| Baytril | 
Baytril is a synthetic, broad spectrum antibiotic used in dogs, cats, rabbits, chickens and other animals. For use in dogs and cats it is normally supplied as Baytril flavour tablets. Baytril can be used in a wide variety of other animals, and for these Baytril Oral Solution is normally best. Baytril has been used very widely in rabbits, guinea pigs, rats, mice, hamsters, as well as many species of bird and reptile. The solution can be added to drinking water, or placed directly in the mouth. If it is placed in drinking water, it should not be in a metal dispenser if possible as this may denature it chemically and reduce its effectiveness. Baytril is also available as an injection or in a doser for use in piglets. Baytril treats a wide variety of bacterial infections of the alimentary, respiratory and urogenital
tracts and skin. Where possible the veterinary surgeon should perform sensitivity testing of
the bacteria involved before deciding if Baytril is appropriate.
| | | | Baytril | 2.5% Oral Solution » 100ml
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£19.22
(inc. VAT) | | 2.5% Solution for Injection » 50ml
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£13.18
(inc. VAT) | | 5% Solution for Injection » 100ml
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£29.17
(inc. VAT) | | 10% Oral Solution » 1 Litre
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£141.38
(inc. VAT) | | 10% Oral Solution » 100ml
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£42.38
(inc. VAT) | | 10% Solution for Injection » 100ml
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£49.28
(inc. VAT) | | Flavour Tablets 15mg » Priced per Tablet
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£0.38
(inc. VAT) | | Flavour Tablets 50mg » Priced per Tablet
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£0.80
(inc. VAT) | | Flavour Tablets 150mg » Priced per Tablet
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£1.74
(inc. VAT) | | Max Solution for Injection » 100ml
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£53.04
(inc. VAT) | | Piglet Doser 0.5% » 100ml
• Usually ships in 24 hours, subject to prescription.
• Veterinary prescription from your vet required. (what's this?) |
£18.43
(inc. VAT) | | |
Baytril should not be used in young growing animals as it can have an adverse effect on the cartilage in joints. Overdosing cats can cause eye damage so accurate dosing is important. The usual dose rate is 5mg/kg bodyweight. For full datasheet information of each product, click on its description above.
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Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction 
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
A ready to use oral solution containing as active ingredient 25 mg/ml enrofloxacin, and 14 mg/ml benzyl alcohol as a preservative.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action with activity against many gram positive and gram negative bacteria as well as mycoplasmas.
Baytril 2.5% Oral Solution is indicated for use in calves for the treatment of infections of the alimentary and respiratory tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis and salmonellosis), where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Baytril 2.5% Oral Solution may also be used in exotic animals (small mammals, reptiles and avian species) for the treatment of bacterial infections of the alimentary and respiratory tracts where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration Calves
Baytril 2.5% Oral Solution is administered via the milk, milk replacer, electrolyte solution or water. The dose rate is 2.5 mg per kg body weight (5 ml per 50 kg) daily for 3 days. This rate may be doubled to 5 mg per kg (10 ml per 50 kg) for 5 days for salmonellosis and complicated respiratory disease. Medicated fluids should be made up immediately prior to provision on a daily basis.
Exotic animals
See Table 1.
The dose rates given are for guidance only. Veterinary surgeons are advised to contact the company prior to use to discuss the particulars of each individual case. |
Table 1: Dosage for Baytril 2.5% Oral Solution | |
Species |
Dosage |
Route |
Dose Frequency |
Treatment period | |
Small mammals |
5 mg enrofloxacin per kg bodyweight
(0.2 ml/kg bw) |
Orally diluted in water |
Twice daily |
7 days | |
Reptiles |
5 mg enrofloxacin per kg bodyweight
(0.2 ml/kg bw) |
Orally diluted in water |
24-48 hour intervals |
6 days |
Birds
(excluding chickens and turkeys) |
10 mg enrofloxacin per kg bodyweight
(0.4 ml/kg bw) |
Orally diluted in water |
Twice daily |
7 days |
For direct administration by gavage, dilutions of 1 part Baytril 2.5% Oral Solution to 4 parts water are recommended. If the product is to be given via the drinking water, concentrations of between 50 and 200 ppm should be considered as suitable working dilutions. Concentrations in excess of 250 ppm should be avoided as precipitation may occur. The dilution should be made on a daily basis, immediately prior to provision, preferably in a glass container. The use of 0.5 ml (100 unit) insulin syringe should be considered for the withdrawal of the very small volumes of Baytril 2.5% Oral Solution required for dilution prior to administration.
Treatment may be initiated with Baytril 2.5% Injection and maintained with Baytril 2.5% Oral Solution.
Medicated fluids should be made up immediately prior to provision on a daily basis.
Use during pregnancy and lactation
In the absence of data on its use in some exotic species, caution should be used when prescribing during these periods and a careful risk/benefit assessment made.
Contra-indications, warnings, etc
Baytril 2.5% Oral Solution should not be used for prophylaxis.
Consult the Technical Services Department of Bayer prior to use in exotic animals.
Official and local antimicrobal policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Wherever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given on the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
During the period of rapid growth, enrofloxacin may affect articular cartilage.
Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.
For animal treatment only.
This product should not be used for the treatment of poultry (chickens and turkeys). Baytril 10% Oral Solution is indicated for these animals.
Not for use in exotic animals or birds intended for human consumption.
User safety
Wear impervious gloves when handling the product.
Wash any splashes from skin or eyes immediately with water.
Wash hands and exposed skin after use.
Do not eat, drink or smoke whilst using the product.
Withdrawal Periods
Calves must not be slaughtered for human consumption during treatment. Calves may be slaughtered for human consumption only after 8 days from the last treatment.
Not for use in exotic animals or birds intended for human consumption.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Keep out of reach of children.
Following withdrawal of the first dose use the product within 28 days.
Any medicated liquid remaining 24 hours after preparation must be discarded.
Any unused product or waste material should be disposed of in accordance with national requirements.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin are such that both oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
White high density polyethylene bottles with a polypropylene screw cap containing 100 ml.
Marketing authorisation number
Vm 00010/4078
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
A ready to use sterile clear pale yellow aqueous injectable solution containing 25 mg/ml enrofloxacin and 30 mg/ml n-butyl alcohol as a preservative.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action with activity against many gram positive and gram negative bacteria and mycoplasmas.
The product is for use in dogs and cats in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism indicates enrofloxacin as the drug of choice.
The product may also be used in exotic animals (small mammals, reptiles and avian species) for the treatment of bacterial infections of the alimentary and respiratory tracts where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration Dogs and cats
1 ml of product per 5 kg body weight (5 mg enrofloxacin per kg body weight) by subcutaneous injection once daily for 3 to 5 days. Treatment may be initiated with the injection and maintained orally with Baytril Flavour Tablets.
Exotic animals
See Table 1.
The dose rates given below are for guidance only. Veterinary surgeons are advised to contact the company prior to use to discuss the particulars of each individual case. The use of a 0.5 ml (100 unit) insulin syringe should be considered for administration of the very small volumes required by some species of small mammals (mice, gerbils etc).
Table 1: Dosage for Baytril 2.5% Solution for Injection
| Species
| Dosage
| Route
| Dose Frequency
| Treatment period
| Small mammals
| 5 mg/kg bw
(0.2 ml/kg)
| s.c.
| Twice daily
| 7 days
| Reptiles
| 5 mg/kg bw
(0.2 ml/kg)
| i.m.
| 24-48 hour intervals
| 6 days
| Avian spp
| 10 mg/kg bw
(0.4 ml/kg)
| i.m.
| Twice daily
| 7 days
|
Treatment may be initiated with the injection and maintained with Baytril 2.5% Oral Solution. Use during pregnancy and lactation
There is no restriction on the use of this product during pregnancy and lactation of the bitch and queen.
In the absence of data on its use in some exotic species, caution should be used when prescribing during these periods and a careful risk/benefit assessment made. Contra-indications, warnings, etc
Baytril 2.5% Injection should not be used for prophylaxis.
Dogs:Not for use in dogs less than one year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age.
In dogs enrofloxacin may affect articular cartilage during the period of rapid growth.
Occasionally skin reactions have been seen after administration to kennelled greyhounds.
Cats:Not for use in cats less than 8 weeks of age.
Retinotoxic effects including blindness can occur when the recommended dose is exceeded.
Exotic animals:Muscle bruising after injection in reptiles and birds has been reported occasionally.
Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken.
Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.
There is no restriction on the use of this product during pregnancy and lactation of the bitch or queen. In the absence of data on its use in some exotic species, caution should be used when prescribing during these periods and a careful risk/benefit assessment made.
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15mg/kg once daily for 21 consecutive days. Doses of 30mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50mg/kg given once daily for 21 consecutive days, blindness can occur.
Not for use in exotic animals or birds intended for human consumption.
User safety:
Baytril 2.5% Solution for Injection is an alkaline solution. Wash any splashes from skin or eyes immediately with water
Do not eat, drink or smoke whilst using the product.
Care should be taken to avoid accidental self-injection. If accidental injection occurs, seek medical advice immediately.
Pharmaceutical precautions
Do not store above 25°C.
Following withdrawal of the first dose, use the product within 28 days.
Any unused product or waste material should be disposed of in accordance with national requirements.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin in dogs and cats are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
50 ml amber type II glass vials with a grey teflonised butyl rubber stopper or a chlorobutyl PTFE stopper.
Marketing authorisation number
Vm 00010/4075
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
Baytril 5% Solution for Injection is a clear sterile light yellow solution for injection containing as active ingredient enrofloxacin 50 mg/ml with 30 mg/ml n-butyl alcohol as a preservative.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action and effective against many gram positive and gram negative bacteria and mycoplasmas.
Dogs and Cats
The product is indicated in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Cattle
Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis) and secondary bacterial infections subsequent to viral conditions (e.g. viral pneumonia) where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Pigs
Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal origin (e.g. pasteurellosis, actinobacillosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis) and mulifactorial diseases such as atrophic rhinitis and enzootic pneumonia, where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration Dogs and Cats
1 ml product per 10 kg bodyweight (5 mg enrofloxacin per kg bodyweight) by subcutaneous injection once daily for up to 5 days. Treatment may be initiated with the injection and maintained orally with Baytril Flavour Tablets.
Cattle
0.5 ml per 10 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by subcutaneous injection for 3 days. This rate may be doubled (1 ml per 10 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 10 ml should be administered at one subcutaneous injection site.
Pigs
0.5 ml per 10 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by intramuscular injection for 3 days. This rate may be doubled (1 ml per 10 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 2.5 ml should be administered at one intramuscular injection site.
Use during pregnancy and lactation
There is no restriction on the use of this product during pregnancy and lactation.
Contra-indications, warnings, etc
Baytril 5% Injection should not be used for prophylaxis.
Dogs under 1 year of age should not be treated with Baytril as damage to the articular cartilage may occur during the period of rapid growth, specifically in large breeds of dog. As a precaution very large breeds of dog should not be treated with Baytril until they are 18 months of age because of their longer growth period.
Not for use in cats less than 8 weeks of age.
Do not exceed the recommended dosage. In accidental overdose there is no antidote and treatment should be symptomatic.
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
During the period of rapid growth, enrofloxacin may affect articular cartilage.
Local tissue reactions may occur at the injection site. Normal sterile precautions should be taken. Repeat injections should be made at different sites.
Cats: Retinotoxic effects including blindness can occur when the recommended dose is exceeded. In accidental overdose there is no antidote and treatment should be symptomatic.
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15mg/kg once daily for 21 consecutive days. Doses of 30mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50mg/kg given once daily for 21 consecutive days, blindness can occur.
Dogs: Occasionally skin reactions have been seen after administration to kennelled greyhounds.
Withdrawal Periods
MEAT
Cattle: Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 14 days from the last treatment.
Pigs: Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 10 days from the last treatment.
MILK
Not to be used in animals producing milk for human consumption.
User Safety: Baytril 5% Solution for Injection is an alkaline solution. Wash any splashes from skin and eyes immediately with water.
Do not eat, drink or smoke whilst using the product.
Care should be taken to avoid accidental self-injection. If accidental injection occurs, seek medical advice immediately.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Unused product or waste material should be disposed of in accordance with national requirements.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication.
Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin in dogs and cats are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
100 ml amber type II glass vials with a grey teflonised butyl rubber stopper or a chlorobutyl PTFE stopper.
Marketing authorisation number
Vm 00010/4076
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
A clear yellowish oral solution containing as active ingredient 100 mg/ml enrofloxacin, and 14 mg/ml benzyl alcohol as a preservative.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action by a concentration - dependant activity against many gram positive and gram negative bacteria as well as mycoplasmas.
It is indicated for use in turkeys, broiler chickens, broiler breeders and pullets being reared as layers for treatment of diseases of the respiratory and alimentary tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis), where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration
The product is administered via the drinking water. Medicated water should be made up immediately prior to provision. Medication of the water supply should be continuous during the treatment period and no other source of water should be available.
The product should be given over a minimum period of 6 hours per day to allow all birds to drink.
The dose rate is 10 mg per kg body weight daily for 3 to 10 days.
Each ml of Baytril 10% Oral Solution contains 100 mg enrofloxacin.
Calculate the daily quantity (ml) of Baytril 10% Oral Solution required for treatment period as follows:
Total number of birds x Average body weight in kg x 0.1 = Total volume of Baytril 10% Oral Solution (ml) per day
Baytril may be put directly into the header tank or introduced via a water proportioner pump.
For the treatment of salmonellosis or pasteurellosis a treatment period of 5 to 10 days must be used.
For other conditions the duration of treatment may be 3 to 5 days.
Contra-indications, warnings, etc
The product should not be used for prophylaxis.
Do not exceed the recommended dose.
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly to other classes of antimicrobials. Wherever possible fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given on the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Do not use in poultry producing eggs for human consumption.
Do not administer to layer replacement birds within 14 days of coming into lay.
User safety
Wear impervious gloves when handling the product.
Wash any splashes from skin or eyes immediately with water.
Wash hands and exposed skin after use.
Do not eat, drink or smoke whilst using the product.
Withdrawal Periods
Animals must not be slaughtered for human consumption during treatment. Chickens and turkeys may be slaughtered for human consumption only after 8 days from the last treatment.
Not for use in birds producing eggs for human consumption.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Store away from food, drink and animal feedingstuffs.
Following withdrawal of the first dose use the product within 28 days.
Medicated water should be made up on a daily basis. Any medicated water remaining 24 hours after preparation must be discarded.
Any unused product and containers should be disposed of in accordance with national requirements.
Shelf life after first opening the immediate packaging : 28 days.
Shelf life after dilution or reconstitution according to directions : 24 hours.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action by a concentration-dependant killing activity against many Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 higher than that found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
Cardboard box containing 1 white high density polyethylene bottle of 100 ml with a white polypropylene screw cap.
White high density polyethylene bottle of 1,000 ml with a white polypropylene screw cap.
Marketing authorisation number
Vm 00010/4077
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
A clear yellowish oral solution containing as active ingredient 100 mg/ml enrofloxacin, and 14 mg/ml benzyl alcohol as a preservative.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action by a concentration - dependant activity against many gram positive and gram negative bacteria as well as mycoplasmas.
It is indicated for use in turkeys, broiler chickens, broiler breeders and pullets being reared as layers for treatment of diseases of the respiratory and alimentary tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis), where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration
The product is administered via the drinking water. Medicated water should be made up immediately prior to provision. Medication of the water supply should be continuous during the treatment period and no other source of water should be available.
The product should be given over a minimum period of 6 hours per day to allow all birds to drink.
The dose rate is 10 mg per kg body weight daily for 3 to 10 days.
Each ml of Baytril 10% Oral Solution contains 100 mg enrofloxacin.
Calculate the daily quantity (ml) of Baytril 10% Oral Solution required for treatment period as follows:
Total number of birds x Average body weight in kg x 0.1 = Total volume of Baytril 10% Oral Solution (ml) per day
Baytril may be put directly into the header tank or introduced via a water proportioner pump.
For the treatment of salmonellosis or pasteurellosis a treatment period of 5 to 10 days must be used.
For other conditions the duration of treatment may be 3 to 5 days.
Contra-indications, warnings, etc
The product should not be used for prophylaxis.
Do not exceed the recommended dose.
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly to other classes of antimicrobials. Wherever possible fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given on the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Do not use in poultry producing eggs for human consumption.
Do not administer to layer replacement birds within 14 days of coming into lay.
User safety
Wear impervious gloves when handling the product.
Wash any splashes from skin or eyes immediately with water.
Wash hands and exposed skin after use.
Do not eat, drink or smoke whilst using the product.
Withdrawal Periods
Animals must not be slaughtered for human consumption during treatment. Chickens and turkeys may be slaughtered for human consumption only after 8 days from the last treatment.
Not for use in birds producing eggs for human consumption.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Store away from food, drink and animal feedingstuffs.
Following withdrawal of the first dose use the product within 28 days.
Medicated water should be made up on a daily basis. Any medicated water remaining 24 hours after preparation must be discarded.
Any unused product and containers should be disposed of in accordance with national requirements.
Shelf life after first opening the immediate packaging : 28 days.
Shelf life after dilution or reconstitution according to directions : 24 hours.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action by a concentration-dependant killing activity against many Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 higher than that found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
Cardboard box containing 1 white high density polyethylene bottle of 100 ml with a white polypropylene screw cap.
White high density polyethylene bottle of 1,000 ml with a white polypropylene screw cap.
Marketing authorisation number
Vm 00010/4077
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
A ready to use sterile aqueous solution for injection containing as active ingredient 100 mg/ml enrofloxacin, and 30 mg/ml n-butyl alcohol as a preservative.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action and effective against many gram positive and gram negative bacteria and mycoplasmas.
Cattle
Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis) and secondary bacterial infections subsequent to viral infections (e.g. viral pneumonia) where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating dairy cattle caused by E. coli, where herd history and previous sensitivity testing indicate enrofloxacin as the drug of choice.
Pigs
Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis), and multifactorial diseases such as atrophic rhinitis and enzootic pneumonia, where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration Cattle
For respiratory and alimentary infections in cattle and secondary bacterial infections: administer by subcutaneous injection.
2.5 ml per 100 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by subcutaneous injection for 3 days. This rate may be doubled (5 ml per 100 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 10 ml should be administered at any one injection site.
For E. coli mastitis: administer by slow intravenous injection.
5.0 ml per 100 kg bodyweight (5 mg enrofloxacin per kg bodyweight) daily for 2 days.
Pigs
For respiratory and alimentary infections in pigs and secondary bacterial infections: administer by intramuscular injection.
2.5 ml per 100 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by intramuscular injection for 3 days. This rate may be doubled (5 ml per 100 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 2.5 ml should be administered at any one injection site in store pigs or 5 ml at any one site in sows.
To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Use during pregnancy and lactation
There is no restriction on the use of this product during pregnancy and lactation.
Contra-indications, warnings, etc
Baytril 10% Solution for Injection should not be used for prophylaxis.
The safety of this product has not been established in pigs or calves when administered by the intravenous route, and use of this route of administration is not recommended in these animal groups.
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly to other classes of antimicrobials. Wherever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Do not exceed the recommended dose. In accidental overdosage there is no antidote and treatment should be symptomatic.
Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken.
User safety
Baytril 10% Solution for Injection is an alkaline solution, wash any splashes from skin or eyes immediately with water.
Do not eat, drink or smoke whilst using the product.
Care should be taken to avoid accidental self injection. If accidental self injection occurs seek medical advice immediately.
Withdrawal Periods
MEAT
Cattle:
Subcutaneous Use
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 10 days from the last treatment.
Intravenous Use
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 4 days from the last treatment.
Pigs: Animals must not be slaughtered for human consumption during treatment. Pigs may be slaughtered for human consumption only after 10 days from the last treatment.
MILK
Subcutaneous Use
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 84 hours (i.e. 7 milkings) from the last treatment.
Intravenous Use
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be
taken from cattle after 72 hours (i.e 6 milkings) from the last treatment.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Following withdrawal of the first dose use the product within 28 days. Discard unused material.
Any unused product or waste material should be disposed of in accordance with national requirements.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics.
Enrofloxacin is bactericidal in action with activity against a wide range of Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
Molecular resistance to fluoroquinolones has been observed to arise from two principal sources, (i) alteration to DNA gyrase or topoisomerase IV and (ii) alterations in drug permeability of the bacterial cell. Both mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Clinical resistance is dependent on several mutations accumulating in a step-wise manner. The pharmacokinetics of enrofloxacin are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 higher than that found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
After an intravenous dose of 5 mg enrofloxacin per kg body weight (bw) to lactating dairy cattle, the total systemic exposure over the dosing interval of 24 h was at 7.1 mg*h/L. In cattle serum, approximately 30% of drug exposure (2.31 mg*h/L) consisted of ciprofloxacin, the active metabolite of enrofloxacin. The drug was well distributed into the body compartments (Venro = 1.5 L/kg, Vcipro = 8.51 L/kg). Total body clearance was 0.71 L/h/kg. In milk, most of drug activity consisted of ciprofloxacin. Overall drug concentrations peaked at 4.1 mg/kg two hours after treatment. Overall drug exposure over 24 h was
22.1 mg*h/L. The actives were eliminated from milk with a mean exposure half-life of 2.8 h.
Legal category
POM-V
Packaging Quantities
100 ml type II amber glass vial with a grey teflonised butyl rubber stopper or a chlorobutyl PTFE stopper.
Marketing authorisation number
Vm 00010/4080
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Incorporating the data sheets for the following products:
Baytril Flavour Tablets 15 mg
Baytril Flavour Tablets 50 mg
Baytril Flavour Tablets 150 mg
Baytril Flavour Tablets 250 mg
Presentation
Baytril Flavour Tablets 15 mg are light brown to brown, slightly marbled, round, flavoured tablets containing 15 mg enrofloxacin for oral administration to dogs and cats.
Baytril Flavour Tablets 50 mg 150 mg and 250 mg are light brown to brown, slightly marbled, round, scored, flavoured tablets containing 50 mg, 150 mg or 250 mg enrofloxacin for oral administration to dogs.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action and effective against many gram positive and gram negative bacteria and mycoplasmas.
The product is for use in dogs and cats in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration Dogs and cats
Dogs and cats
The dose rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice daily for 3 to 10 days with or without food. Treatment may be initiated with Baytril 5% Solution for Injection or Baytril 2.5% Solution for Injection and maintained with Baytril Flavour Tablets.
The daily dose is achieved as follows:
Cats and small dogs: Baytril 15 mg – 1 tablet per 3 kg bodyweight
Medium dogs: Baytril 50 mg – 1 tablet per 10 kg bodyweight
Large dogs: Baytril 150 mg – 1 tablet per 30 kg bodyweight
Extra large dogs: Baytril 250 mg – 1 tablet per 50 kg bodyweight – Tablets can be halved to achieve the appropriate dose in dogs above 50 kg.
Use during pregnancy and lactation
The product may be used safely in pregnant and lactating animals.
Contra-indications, warnings, etc
Baytril flavour tablets should not be used for prophylaxis.
Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth.
Not recommended for use in cats less than 8 weeks of age.
Do not exceed the recommended dose. In accidental overdose, vomiting, diarrhoea, and CNS/behavioural changes may occur. There is no antidote and treatment should be symptomatic.
In cats, retinotoxic effects including blindness can occur when the recommended dose is exceeded.
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days.
Doses of 30 mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50 mg/kg given once daily for 21 consecutive days, blindness can occur.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Return any halved 250 mg Tablets to the opened blister and use within 7 days.
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics.
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration lead to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2–3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone, and lymphatic system. Enrofloxacin also distributes into the C.S.F., the aqueous humour, and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
Baytril Flavour Tablets 15mg, 50 mg, 150 mg:
Silver coloured aluminium foil blister strips of 10 tablets supplied in dispensing cartons containing 100 tablets.
Baytril Flavour Tablets 250 mg:
Silver coloured aluminium foil blister strips of 6 tablets supplied in dispensing cartons containing 96 tablets.
Marketing authorisation numbers Baytril® Flavour Tablets 15 mg tablets
| Vm 00010/4081
| Baytril® Flavour Tablets 50 mg tablets
| Vm 00010/4082
| Baytril® Flavour Tablets 150 mg tablets
Baytril® Flavour Tablets 250 mg tablets
| Vm 00010/4083
Vm 00010/4169
|
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Incorporating the data sheets for the following products:
Baytril Flavour Tablets 15 mg
Baytril Flavour Tablets 50 mg
Baytril Flavour Tablets 150 mg
Baytril Flavour Tablets 250 mg
Presentation
Baytril Flavour Tablets 15 mg are light brown to brown, slightly marbled, round, flavoured tablets containing 15 mg enrofloxacin for oral administration to dogs and cats.
Baytril Flavour Tablets 50 mg 150 mg and 250 mg are light brown to brown, slightly marbled, round, scored, flavoured tablets containing 50 mg, 150 mg or 250 mg enrofloxacin for oral administration to dogs.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action and effective against many gram positive and gram negative bacteria and mycoplasmas.
The product is for use in dogs and cats in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration Dogs and cats
Dogs and cats
The dose rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice daily for 3 to 10 days with or without food. Treatment may be initiated with Baytril 5% Solution for Injection or Baytril 2.5% Solution for Injection and maintained with Baytril Flavour Tablets.
The daily dose is achieved as follows:
Cats and small dogs: Baytril 15 mg – 1 tablet per 3 kg bodyweight
Medium dogs: Baytril 50 mg – 1 tablet per 10 kg bodyweight
Large dogs: Baytril 150 mg – 1 tablet per 30 kg bodyweight
Extra large dogs: Baytril 250 mg – 1 tablet per 50 kg bodyweight – Tablets can be halved to achieve the appropriate dose in dogs above 50 kg.
Use during pregnancy and lactation
The product may be used safely in pregnant and lactating animals.
Contra-indications, warnings, etc
Baytril flavour tablets should not be used for prophylaxis.
Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth.
Not recommended for use in cats less than 8 weeks of age.
Do not exceed the recommended dose. In accidental overdose, vomiting, diarrhoea, and CNS/behavioural changes may occur. There is no antidote and treatment should be symptomatic.
In cats, retinotoxic effects including blindness can occur when the recommended dose is exceeded.
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days.
Doses of 30 mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50 mg/kg given once daily for 21 consecutive days, blindness can occur.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Return any halved 250 mg Tablets to the opened blister and use within 7 days.
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics.
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration lead to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2–3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone, and lymphatic system. Enrofloxacin also distributes into the C.S.F., the aqueous humour, and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
Baytril Flavour Tablets 15mg, 50 mg, 150 mg:
Silver coloured aluminium foil blister strips of 10 tablets supplied in dispensing cartons containing 100 tablets.
Baytril Flavour Tablets 250 mg:
Silver coloured aluminium foil blister strips of 6 tablets supplied in dispensing cartons containing 96 tablets.
Marketing authorisation numbers Baytril® Flavour Tablets 15 mg tablets
| Vm 00010/4081
| Baytril® Flavour Tablets 50 mg tablets
| Vm 00010/4082
| Baytril® Flavour Tablets 150 mg tablets
Baytril® Flavour Tablets 250 mg tablets
| Vm 00010/4083
Vm 00010/4169
|
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Incorporating the data sheets for the following products:
Baytril Flavour Tablets 15 mg
Baytril Flavour Tablets 50 mg
Baytril Flavour Tablets 150 mg
Baytril Flavour Tablets 250 mg
Presentation
Baytril Flavour Tablets 15 mg are light brown to brown, slightly marbled, round, flavoured tablets containing 15 mg enrofloxacin for oral administration to dogs and cats.
Baytril Flavour Tablets 50 mg 150 mg and 250 mg are light brown to brown, slightly marbled, round, scored, flavoured tablets containing 50 mg, 150 mg or 250 mg enrofloxacin for oral administration to dogs.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action and effective against many gram positive and gram negative bacteria and mycoplasmas.
The product is for use in dogs and cats in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration Dogs and cats
Dogs and cats
The dose rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice daily for 3 to 10 days with or without food. Treatment may be initiated with Baytril 5% Solution for Injection or Baytril 2.5% Solution for Injection and maintained with Baytril Flavour Tablets.
The daily dose is achieved as follows:
Cats and small dogs: Baytril 15 mg – 1 tablet per 3 kg bodyweight
Medium dogs: Baytril 50 mg – 1 tablet per 10 kg bodyweight
Large dogs: Baytril 150 mg – 1 tablet per 30 kg bodyweight
Extra large dogs: Baytril 250 mg – 1 tablet per 50 kg bodyweight – Tablets can be halved to achieve the appropriate dose in dogs above 50 kg.
Use during pregnancy and lactation
The product may be used safely in pregnant and lactating animals.
Contra-indications, warnings, etc
Baytril flavour tablets should not be used for prophylaxis.
Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth.
Not recommended for use in cats less than 8 weeks of age.
Do not exceed the recommended dose. In accidental overdose, vomiting, diarrhoea, and CNS/behavioural changes may occur. There is no antidote and treatment should be symptomatic.
In cats, retinotoxic effects including blindness can occur when the recommended dose is exceeded.
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days.
Doses of 30 mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50 mg/kg given once daily for 21 consecutive days, blindness can occur.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Return any halved 250 mg Tablets to the opened blister and use within 7 days.
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics.
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration lead to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2–3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone, and lymphatic system. Enrofloxacin also distributes into the C.S.F., the aqueous humour, and the foetus in pregnant animals.
Legal category
POM-V
Packaging Quantities
Baytril Flavour Tablets 15mg, 50 mg, 150 mg:
Silver coloured aluminium foil blister strips of 10 tablets supplied in dispensing cartons containing 100 tablets.
Baytril Flavour Tablets 250 mg:
Silver coloured aluminium foil blister strips of 6 tablets supplied in dispensing cartons containing 96 tablets.
Marketing authorisation numbers Baytril® Flavour Tablets 15 mg tablets
| Vm 00010/4081
| Baytril® Flavour Tablets 50 mg tablets
| Vm 00010/4082
| Baytril® Flavour Tablets 150 mg tablets
Baytril® Flavour Tablets 250 mg tablets
| Vm 00010/4083
Vm 00010/4169
|
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
A ready to use clear yellow sterile aqueous injectable solution containing as active ingredient 100 mg/ml enrofloxacin, with 20 mg/ml benzyl alcohol and 30 mg/ml butyl alcohol as preservatives.
Uses Cattle
The product is indicated for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma species, where clinical experience, supported where possible, by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Indicated for the treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating dairy cattle caused by E. coli, where herd history and previous sensitivity testing indicate enrofloxacin as the drug of choice.
Dosage and administration Dosage and duration of treatment
For respiratory infections in cattle: administer by subcutaneous injection.
A single dose of 7.5 mg/kg body weight (7.5 ml per 100 kg body weight)
Not more than 15 ml should be administered at one subcutaneous injection site.
For E.coli mastitis in cattle: administer by slow intravenous injection.
5.0 ml per 100 kg body weight (5 mg enrofloxacin per kg body weight) daily for 2 days.
To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Use during pregnancy and lactation
Not restricted
Contra-indications, warnings, etc
Baytril Max 10% Solution for Injection should not be used for prophylaxis.
The safety of the product has not been established in calves when administered by the intravenous route and use of this route of administration in calves is therefore not recommended.
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Transient local reactions may occur at injection site. Normal sterile precautions should be taken.
Do not exceed the recommended dose. A dose of 25 mg/kg bodyweight administered by the subcutaneous route for 15 consecutive days is tolerated without any clinical symptoms. Clinical signs seen in gross overdosage include lethargy, lameness, ataxia, slight salivation and muscle tremors. In accidental overdose there is no antidote and treatment should be symptomatic.
User safety
Baytril Max is an alkaline solution.
Wash any splashes from skin or eyes immediately with water.
Do not eat, drink or smoke whilst using the product.
Care should be taken to avoid self-injection. If accidental self-injection occurs, seek medical advice immediately.
Withdrawal Periods
Subcutaneous Use: Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 14 days from the injection. Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 84 hours (i.e. 7 milkings) from the last treatment.
Intravenous Use: Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 4 days from the injection. Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 72 hours (i.e. 6 milkings) from the last treatment.
Pharmaceutical precautions
Store below 25°C. Do not freeze.
Following withdrawal of the first dose, use product within 28 days. Discard if visibly contaminated.
Any unused product and containers should be disposed of in accordance with national requirements.
Legal category
POM-V
Packaging Quantities
Individually packed multi-dose bottles of 100 ml amber type I glass with siliconised grey rubber butyl stopper.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance belonging to the fluoroquinolone group of antibiotics.
It is bactericidal in action with activity against many Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall but are inactive against strict anaerobes.
Molecular resistance to fluoroquinolones has been observed to arise from two principal sources, (i) alteration to DNA gyrase or topoisomerase IV and (ii) alterations in drug permeability of the bacterial cell. Both mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Clinical resistance is dependent on several mutations accumulating in a step-wise manner.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin is lipid soluble and amphoteric and possesses a high distribution volume. Tissue levels 2-3 higher than that found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
After subcutaneous administration of 7.5 mg/kg the mean peak plasma concentration is 0.8 µg/ml achieved within 6 hours. Enrofloxacin is partly metabolised in the liver. Approximately 45 per cent of the dose is excreted in the urine and 55 per cent in the faeces as active and metabolites.
After an intravenous dose of 5 mg enrofloxacin per kg body weight (bw) to lactating dairy cattle, the total systemic exposure over the dosing interval of 24 h was at 7.1 mg*h/L. In cattle serum, approximately 30% of drug exposure (2.31 mg*h/L) consisted of ciprofloxacin, the active metabolite of enrofloxacin. The drug was well distributed into the body compartments (Venro = 1.5 L/kg, Vcipro = 8.51 L/kg). Total body clearance was 0.71 L/h/kg. In milk, most of drug activity consisted of ciprofloxacin. Overall drug concentrations peaked at 4.1 mg/kg two hours after treatment. Overall drug exposure over 24 h was 22.1 mg*h/L. The actives were eliminated from milk with a mean exposure half-life of 2.8 h.
Marketing authorisation number
Vm 00010/4103
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Presentation
Baytril Piglet Doser is a clear aqueous solution for oral use containing as active ingredient, 5 mg/ml enrofloxacin with 14 mg/ml benzyl alcohol as a preservative.
Uses
Pigs (piglets): The product is for use in the treatment of diseases of the respiratory and alimentary tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis), and multifactorial diseases such as atrophic rhinitis and enzootic pneumonia, where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration
Dose rate is 1.5 – 5 mg enrofloxacin/kg body weight daily. The contents of Baytril Piglet Doser are administered orally using the dosing pump. 1 pump stroke delivers 1 ml.
For piglets up to 3 kg body weight – 1 ml once daily for 3 to 5 days
For piglets 3 kg up to 10 kg body weight – 3 ml once daily for 3 to 5 days
Contra-indications, warnings, etc
The product should not be used for prophylaxis.
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic .
Consumer Safety
Withdrawal Period: Piglets: Meat: 10 days
User Safety
Wear impervious gloves when handling the product.
Wash any splashes from skin or eyes immediately with water.
Wash hands and exposed skin after use.
Do not eat, drink or smoke while using the product.
Environmental Safety
Any unused product or waste material should be disposed of in accordance with national requirements.
Pharmaceutical precautions
Do not store above 25°C.
Following withdrawal of the first dose, use the product within 28 days.
Discard unused material.
Legal category
POM-V
Packaging Quantities
White high density polyethylene bottles with polypropylene screw cap containing 100 ml.
Dosing Device: a polypropylene/polyethylene/stainless steel pump dispensing 1ml
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
Marketing authorisation number
Vm 00010/4079
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