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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 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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Description

Baytril Flavour Tablets

Presentation

Baytril Flavour Tablets 15 mg are light brown to brown, slightly marbled, round, planar, tablets containing 15 mg enrofloxacin and 6 mg artificial beef flavour irradiated for oral administration to dogs and cats.

Baytril Flavour Tablets 50 mg and 150 mg are light brown to brown, slightly marbled, round, curved, scored, tablets containing 50 mg or 150 mg enrofloxacin and 12 mg or 42 mg artificial beef flavour irradiated respectively for oral administration to dogs.

Baytril Flavour Tablets 250 mg are light brown to brown, slightly marbled, tablets containing 250 mg enrofloxacin and 70 mg artificial beef flavour irradiated for oral administration to dogs.

Uses

Baytril Flavour Tablets 15 mg

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.

Baytril Flavour Tablets 50 mg, 150 mg and 250 mg

The product is for use in dogs 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

The dosage 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% Injection or Baytril 2.5% Injection and maintained with Baytril Flavour Tablets.

The daily dose is achieved as follows:

Cats and small dogs: 1 Baytril Flavour Tablet 15 mg per 3 kg bodyweight

Medium dogs: 1 tablet Baytril Flavour Tablets 50 mg per 10 kg bodyweight

Large dogs: 1 tablet Baytril Flavour Tablets 150 mg per 30 kg bodyweight

1 tablet Baytril Flavour Tablets 250 mg 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.

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.

Dogs: In dogs enrofloxacin may affect articular cartilage during the period of rapid growth.

Environmental safety

Any unused product or waste material should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Baytril Flavour Tablets 15mg, 50 mg and 150 mg:

Do not store above 25°C. Store in a dry place.

Shelf-life as packaged for sale: 5 years

Baytril Flavour Tablets 250 mg:

Do not store above 25°C. Store in a dry place. Store in original package. Return any halved 250 mg tablet to the opened blister and use within 7 days.

Shelf-life as packaged for sale: 3 years

Further information

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. ATC Vet Code: QJ01MA90.

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 cerebrospinal fluid, the aqueous humour, and the foetus in pregnant animals.

Legal category

POM-V

Packaging Quantities

Baytril Flavour Tablets 15mg: Silver or white coloured aluminium foil blister or plastic coated aluminium blister strips of 10 light brown unmarked tablets supplied in dispensing cartons containing 100 tablets.

Baytril Flavour Tablets 50 mg and 150 mg: Silver or white coloured aluminium foil blister or plastic coated aluminium blister strips of 10 light brown to brown, scored tablets supplied in dispensing cartons containing 100 tablets.

Baytril Flavour Tablets 250 mg: Silver or white coloured aluminium foil blister or plastic coated aluminium blister of 6 light brown to brown tablets supplied in dispensing cartons containing 96 tablets.

Marketing authorisation numbers

Baytril Flavour Tablets 15 mg

Vm 00010/4081

Baytril Flavour Tablets 50 mg

Vm 00010/4082

Baytril Flavour Tablets 150 mg

Baytril Flavour Tablets 250 mg

Vm 00010/4083

Vm 00010/4169

GTIN (Global Trade Item No)

Baytril Flavour Tablets 15mg (100 Tablets)

05032756180014

Baytril Flavour Tablets 50 mg (100 Tablets)

05032756280011

Baytril Flavour Tablets 150 mg (100 Tablets)

05032756380018

Baytril Flavour Tablets 250mg (96 Tablets)

04007221025443

Baytril 2.5% Oral Solution

Presentation

An oral solution containing as active ingredient 25 mg/ml enrofloxacin, and 14 mg/ml benzyl alcohol.

Uses

Baytril 2.5% Oral Solution is 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

Administer 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 below are for guidance only. Veterinary surgeons are advised to contact the company prior to use to discuss the particulars of each individual case.

For direct administration by gavage, dilutions of 1 part product 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.

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

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

The product should not be used for prophylaxis.

Exotic animals: Consult the Technical Services Department of Bayer prior to use.

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 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.

Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.

Not for use in poultry (chickens and turkeys).

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 period(s)

Calves: Meat: 8 days

Not for use in exotic animals or birds intended for human consumption.

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. Store in a dry place.

Following withdrawal of the first dose use the product within 28 days.

Any medicated liquid remaining 24 hours after preparation must be discarded.

Shelf-life of the unopened container: 3 years.

Shelf-life of the broached container: Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Shelf-life of the diluted product: Any medicated liquid remaining 24 hours after preparation must be discarded.

Further information

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. ATC Vet Code: QJ01MA90

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

GTIN (Global Trade Item No)

Baytril 2.5% Oral Solution (100ml)

04007221019251

Baytril 10% Oral Solution

Presentation

Clear yellowish oral solution for use in drinking water containing, as active ingredient, enrofloxacin. One ml of Baytril 10% Oral Solution contains 100mg enrofloxacin and 14mg benzyl alcohol

Uses

Baytril 10% Oral Solution is indicated for use in chickens, turkeys and rabbits, for the treatment of respiratory tract and digestive tract infections caused by the following bacteria susceptible to enrofloxacin:

Chickens

Mycoplasma gallisepticum,

Mycoplasma synoviae,

Avibacterium paragallinarum,

Pasteurella multocida,

Escherichia coli.

Turkey

Mycoplasma gallisepticum,

Mycoplasma synoviae,

Pasteurella multocida,

Escherichia coli.

Rabbits

For the treatment of infectious diseases due to Pasteurella multocida and bacterial enteritis due to infection with E.coli.

Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the active substance of choice.

Dosage and administration

Chickens and turkeys

10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days.

Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms. If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.

Via the drinking water. Always make sure that the entire dose offered has been consumed. The medicated water should be made up fresh each day just before it is offered to the animals. The drinking water must be medicated throughout the treatment period, and no other water source should be available. Determine the bodyweight of the birds as accurately as possible in order to avoid underdosing.

Use only fresh pre-solutions, prepared every day before start of treatment. Pumping systems should be checked constantly to assure proper medication. Empty the water system and fill it with medicated water before starting the treatment.

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 (ml) per day

Baytril 10% Oral Solution may be put directly into the header tank or introduced via a water proportioner pump.

Rabbits

10 mg/kg bodyweight per day for 5 consecutive days.

Calculate the daily quantity (ml) of Baytril 10% Oral Solution required for treatment period as follows:

Total number of rabbits x Average body weight in kg x 0.1= Total volume (ml) per day

Use during pregnancy, lactation or lay

Do not use in laying hens producing eggs for human consumption.

Do not administer to layer replacement birds within 14 days of coming into lay

Contra-indications, warnings, etc

Do not use for prophylaxis.

Do not use when resistance/ cross-resistance to (fluoro)quinolones is known to occur.

Do not use in the case of known hypersensitivity to the active substance, other (fluoro)quinolones or to any of the excipients.

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.

Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E.coli to fluoroquinolones and emergence of resistant organisms. Resistance has also been reported in Mycoplasma synoviae in the EU.

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.

In vitro, an antagonism was shown, when combining fluoroquinolones with bacteriostatic antimicrobial agents such as macrolides or tetracyclines and phenicols. The simultaneous application of substances containing aluminium or magnesium can impair the absorption of enrofloxacin.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

No adverse clinical symptoms were observed in chickens and turkeys treated respectively with doses up to 10 and 6 times higher than the therapy dose.

The use of fluoroquinolones during the growth phase combined with a marked and prolonged increase in the intake of drinking water, and hence active ingredient, possibly due to high temperatures, may potentially be associated with damage of the articular cartilage.

User Safety:

Those with known hypersensitivity to (fluoro)quinolones should avoid contact with this product.

Avoid contact with skin and eyes.

Rinse 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.

Withdrawal period(s)

Chickens: Meat and offal: 3 days.

Turkeys: Meat and offal: 3 days.

Rabbits: Meat and offal: 15 days.

Not authorised for use in birds producing eggs for human consumption.

Do not administer to layer replacement birds within 14 days of coming into lay.

Environmental Safety:

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Pharmaceutical precautions

This veterinary medicinal product does not require any special storage conditions.

Shelf life of the veterinary medicinal product as packaged for sale: 4 years

Shelf-life after first opening the immediate packaging: 12 weeks

Shelf-life after dilution or reconstitution according to directions: 24 hours

Further information

Pharmacotherapeutic group: quinolone and quinoxaline antibacterials, fluoroquinolones. ATCvet Code QJ01MA90.

Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones. They modulate the topological state of DNA through cleaving and resealing reactions. Initially, both strands of the DNA double helix are cleaved. Then, a distant segment of DNA is passed through this break before the strands are resealed. Target inhibition is caused by non-covalent binding of fluoroquinolone molecules to an intermediate state in this sequence of reactions, in which DNA is cleaved, but both strands are retained covalently attached to the enzymes. Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependant killing of pathogenic bacteria.

Enrofloxacin is active against many Gram-negative bacteria, against Gram-positive bacteria and Mycoplasma spp.

In vitro susceptibility has been shown in strains of (i) Gram-negative species such as Escherichia coli, Pasteurella multocida and Avibacterium (Haemophilus) paragallinarum and (ii) Mycoplasma gallisepticum and Mycoplasma synoviae.

Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins. All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Cross-resistance within the fluoroquinolone class of antimicrobials is common.

Enrofloxacin administered via drinking water to poultry is rapidly and very well absorbed with a bioavailability of approx. 90%. Maximum plasma concentrations of 2 mg/L are reached within 1.5 hours after a single bolus dose rate of 10 mg/kg body weight, with a total systemic availability of 14.4 mg.hr/L. Enrofloxacin is eliminated from the body with a total body clearance of 10.3 ml/min.kg. If dosed as continuous drinking water medication (multiple dosing) steady-state concentrations of 0.5 mg (turkeys) to 0.8 mg (chicken) enrofloxacin per litre are achieved. A high mean volume of distribution (5 L/kg) indicated good tissue penetration of enrofloxacin. Concentrations in target tissues like lungs, liver, kidney, intestine and muscle tissue, exceed plasma concentrations by far. In poultry enrofloxacin is poorly metabolised to its active metabolite ciprofloxacin (approximately 5%). Enrofloxacin is eliminated from the body at a half-life of 6 hours. Protein binding in poultry is approximately 25%.

Legal category

POM-V

Packaging Quantities

100 ml, 500 ml, and 1,000 ml high density polyethylene (HDPE) bottles with an HDPE insert and a polypropylene screw closure.

5,000 ml HDPE canister with an aluminium / HDPE screw closure.

The containers are provided with a graduated polypropylene measuring cup.

Not all pack sizes may be marketed.

Marketing authorisation number

Vm 00010/4077

GTIN (Global Trade Item No)

Baytril 10% Oral Solution (100 ml)

04007221027157

Baytril 10% Oral Solution (1 Litre)

04007221027133

Baytril 2.5% Solution for Injection

Presentation

A clear pale yellow sterile aqueous solution for injection containing 25 mg/ml enrofloxacin and 30 mg/ml n-butyl alcohol.

Uses

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 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 the administration of the 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

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.

Baytril 2.5% Solution for Injection should not be used for prophylaxis.

Do not exceed the recommended dosage. 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 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.

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.

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.

Shelf-life of the product as packaged for sale: 3 years.

Shelf-life after first opening the container: Following withdrawal of the first dose, use the product within 28 days.

Further information

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. ATC Vet Code: QJ01MA90

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 bottle with a grey teflonised butyl rubber stopper or a chlorobutyl PTFE stopper.

Marketing authorisation number

Vm 00010/4075

GTIN (Global Trade Item No)

Baytril 2.5% Solution for Injection (50ml)

04007221019268

Baytril 5% Solution for Injection

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

Dogs and Cats

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

5mg enrofloxacin per kg bodyweight (1.0 ml/10 kg) daily by subcutaneous injection once daily for up to 5 days. Treatment may be initiated with the product and maintained with Baytril Flavour Tablets.

Cattle

2.5 mg enrofloxacin per kg bodyweight (0.5 ml/10 kg) daily by subcutaneous injection for 3 days. This rate may be doubled to 5 mg enrofloxacin per kg bodyweight (1.0 ml/10 kg) for 5 days for salmonellosis and complicated respiratory diseases. Not more than 10 ml should be administered at the one subcutaneous injection site.

Pigs

2.5 mg enrofloxacin per kg bodyweight (0.5 ml/10 kg) daily by intramuscular injection for 3 days. This rate may be doubled to 5 mg enrofloxacin per kg bodyweight (1.0 ml/10 kg) for 5 days for salmonellosis and complicated respiratory diseases. Not more than 2.5 ml should be administered at the one intramuscular 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% Solution for 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 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.

Dogs: Occasionally skin reactions have been seen after administration to kennelled greyhounds.

Withdrawal period(s)

MEAT AND OFFAL

Cattle: Meat and Offal: 14 days

Pigs: Meat and Offal 10 days

MILK

Not permitted for use in lactating 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.

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.

Store in a dry place.

Shelf-life of the unopened vial: 3 years

Shelf-life of the broached vial: Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Further information

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. ATC Vet Code: QJ01MA90

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.

Marketing authorisation number

Vm 00010/4076

GTIN (Global Trade Item No)

Baytril 5% Solution for Injection (100ml)

05032756076010

Baytril 10% Solution for Injection

Presentation

A ready to use solution for injection containing as active ingredient 100 mg/ml enrofloxacin, and 30 mg/ml n-butyl alcohol.

Uses

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

To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Cattle

For respiratory and alimentary infections in cattle and secondary bacterial infections: administer by subcutaneous injection.

2.5 mg enrofloxacin per kg bodyweight daily by subcutaneous injection for 3 days (2.5 ml per 100 kg bodyweight) This rate may be doubled to 5 mg/kg bodyweight (5 ml per 100 kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 10 ml should be administered at any one subcutaneous 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 mg enrofloxacin per kg bodyweight daily by intramuscular injection for 3 days (2.5 ml per 100 kg bodyweight). This rate may be doubled to 5 mg/kg bodyweight (5 ml per 100 kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 2.5 ml should be administered at any one intramuscular injection site in store pigs or 5 ml at any one intramuscular injection site in sows.

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 Period(s)

Cattle:

Subcutaneous Use

Meat and Offal: 10 days

Milk: 84 hours (7 milkings)

Intravenous Use

Meat and Offal: 4 days

Milk: 72 hours (6 milkings)

Pigs:

Intramuscular Use

Meat and Offal: 10 days

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. Store in a dry place.

Shelf-life of the product as packaged for sale: 3 years

Shelf-life after first opening the container: Following withdrawal of the first dose use the product within 28 days. Discard unused material.

Further information

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. ATC Vet Code: QJ01MA90.

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

GTIN (Global Trade Item No)

Baytril 10% Solution for Injection (100ml)

05032756080017

Baytril Piglet Doser

Presentation

Baytril Piglet Doser 0.5% Oral Solution is a clear aqueous oral solution containing as active ingredient, 5 mg/ml enrofloxacin and 14 mg/ml benzyl alcohol.

Uses

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 bodyweight – 1 ml once daily for 3 to 5 days.

For piglets 3 kg up to 10 kg bodyweight – 3 ml once daily for 3 to 5 days.

Use during pregnancy and lactation

Not applicable - this product is only indicated for piglets.

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.

Withdrawal period(s)

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.

Shelf-life of the product as packaged for sale: 3 years.

Shelf-life after first opening the container: 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: Polypropylene/polyethylene/stainless steel pump dispensing 1ml

Further information

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. ATC Vet Code: QJ01MA90.

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

GTIN (Global Trade Item No)

Baytril Piglet Doser (100ml)

05032756079011

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