Excenel Antibiotic Injection | 
Excenel is an antibiotic used to treat various serious disease in cattle and pigs, particularly including respiratory disease, uterine infections after giving birth and foot rot.
For full datasheet information, click on the product names below.
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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: Pfizer Limited
Address: Ramsgate Road
Sandwich
Kent CT13 9NJ
Telephone: 0845 300 8034 (Out of hours: 01304 616161)
Fax: 01737 332521
Email: UKVetLine@pfizer.com
Website: www.pfizerah.co.uk
Presentation
Vials containing 50 or 100 ml of a sterile suspension. Each ml contains ceftiofur hydrochloride equivalent to 50 mg ceftiofur.
Uses
Excenel contains ceftiofur which is a β-lactamase resistant, broad spectrum, bactericidal cephalosporin antibiotic and is effective in the treatment of infections associated with bacteria sensitive to ceftiofur. The product is indicated for:-
Cattle
For the treatment of bacterial respiratory disease associated with Mannheimia spp. (Pasteurella haemolytica), Pasteurella multocida and Histophilus somni.
For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica).
For treatment of acute post-partum (puerperal) metritis within 10 days of calving, associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur.
Pigs
For the treatment of bacterial respiratory disease associated with micro-organisms sensitive to ceftiofur: Actinobacillus pleuropneumoniae, Pasteurella multocida and Streptococcus suis.
Dosage and administration Cattle
For the treatment of respiratory disease: 1 mg/kg bwt/day subcutaneously for 3 to 5 days, i.e. 1 ml/50 kg bwt at each injection.
For the treatment of acute interdigital necrobacillosis: 1 mg/kg bwt/day subcutaneously for 3 days, i.e. 1 ml/50 kg bwt at each injection.
For the treatment of acute post-partum metritis: 1 mg/kg bwt/day subcutaneously for 5 consecutive days, i.e. 1 ml/50 kg bwt at each injection.
Subsequent injections must be given at different sites.
Pigs
3 mg ceftiofur/kg bwt (i.e. 1ml/16kg bwt) intramuscularly once daily at 24 hour intervals for 3 days in total.
Contra-indications, warnings, etc
Do not administer to an animal previously found to be hypersensitive to ceftiofur and other β-lactam antibiotics. Do not inject intravenously.
Even though studies in laboratory animals show no evidence of teratogenesis, abortion or influence on reproduction, the reproductive safety of ceftiofur has not been specifically investigated in pregnant sows or cows. Use only according to a benefit/risk assessment by the attending veterinary surgeon.
Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.
In the case of an allergic reaction the treatment should be withdrawn.
Inappropriate use of the product may increase the prevalence of bacteria resistant to cephalosporins.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Cattle
In cattle, mild inflammatory reactions at the injection site, such as tissue oedema and discolouration of the subcutaneous tissue and/or fascial surface of the muscle may be observed. Clinical resolution is reached in most animals by 10 days after injection although slight tissue discolouration may persist for 28 days or more. In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.
Pigs
In pigs, mild reactions at the injection site such as discolouration of the fascia or fat have been observed in some animals for up to 20 days after injection.
The low toxicity of ceftiofur has been demonstrated in swine using ceftiofur sodium at doses in excess of 8 times the recommended daily dose of ceftiofur administered intramuscularly for 15 consecutive days.
Withdrawal Periods
Animals must not be slaughtered for human consumption during treatment.
Milk
Zero days.
Milk for human consumption may be taken during and after last treatment.
Meat
Cattle may be slaughtered for human consumption only after 8 days from last treatment.
Pigs may be slaughtered for human consumption only after 5 days from last treatment.
Operator Warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious:
1.Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2.Handle this product with great care to avoid exposure taking all recommended precautions.
3.If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Pharmaceutical precautions
Keep out of reach of children.
For animal treatment only.
Shake the bottle well before use to bring the product back into suspension. Do not store above 25°C. Following withdrawal of the first dose, use the product within 30 days. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V
Packaging Quantities
Excenel RTU is supplied in 50 or 100 ml vials. Not all pack sizes may be marketed.
Further information
In case of acute post-partum metritis, additional supportive therapy might be required in some cases.
Marketing authorisation number
Vm 00057/4238.
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction 
Company name: Pfizer Limited
Address: Ramsgate Road
Sandwich
Kent CT13 9NJ
Telephone: 0845 300 8034 (Out of hours: 01304 616161)
Fax: 01737 332521
Email: UKVetLine@pfizer.com
Website: www.pfizerah.co.uk
Presentation
Vials containing a powder for solution for injection. Vials contain either 1 g or 4 g ceftiofur as the sterile, freeze-dried sodium salt. Ceftiofur sodium is a white to beige, amorphous powder requiring reconstitution with Water for Injection. Each ml of reconstituted solution contains ceftiofur sodium equivalent to 50 mg ceftiofur.
Uses
Excenel contains ceftiofur which is a beta-lactamase resistant, broad spectrum, bactericidal cephalosporin antibiotic. The product is indicated for:
1.the treatment of cattle with acute respiratory disease in which Pasteurella haemolytica, Pasteurella multocida, Actinobacillus (Haemophilus) somnus or other sensitive bacterial pathogens of the respiratory tract are involved,
2.the treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which Fusobacterium necrophorum and Bacteroides melaninogenicus are involved. As with all antibiotic therapy, treatment of this condition with Excenel should be instituted as early as possible in order to provide maximum clinical effect.
3.the treatment of pigs with bacterial respiratory disease in which Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida and/or Streptococcus suis are involved,
4.the treatment of horses with bacterial respiratory disease in which Streptococcus spp. (including Streptococcus zooepidemicus and Streptococcus equi), Staphylococcus spp. and/or Pasteurella spp are involved.
Dosage and administration Reconstitution
1 g vial. Reconstitute by adding 20 ml Water for Injection.
4 g vial. Reconstitute by adding 80 ml Water for Injection.
For ease of reconstitution use an 18 gauge needle. Rapid addition of diluent will give best results.
Dosage: Cattle
1 mg/kg bodyweight. This is equivalent to 1 ml of the reconstituted solution per 50 kg bodyweight. For respiratory disease, the dose should be given once daily at 24 hour intervals for 3 to 5 days in total. For foul in the foot, the dose should be given once daily at 24 hour intervals for 3 days in total.
Pigs
3 mg/kg bodyweight. This is equivalent to 1 ml of the reconstituted solution per 16 kg bodyweight. The dose should be given once daily at 24 hour intervals for 3 days in total.
If no response is seen within these periods, the diagnosis should be redetermined.
Horses
2 mg/kg bodyweight. This is equivalent to 2 ml of the reconstituted solution per 50 kg bodyweight. The dose should be given once daily at 24 hour intervals and continued for 48 hours after clinical signs have disappeared. A 10 day treatment period is usually adequate. A maximum of 10 ml solution should be administered per injection site. If no response is seen within 4–5 days, the diagnosis should be redetermined.
Administration
The intramuscular route only should be used in cattle, pigs and horses. In the pig, particular care must be taken to avoid injection into fat tissue. Normal aseptic injection techniques should be practiced.
Contra-indications, warnings, etc
The use of Excenel Sterile Powder is contra-indicated in animals previously found to be hypersensitive to ceftiofur.
The use of the product may cause occasional local discomfort upon injection but this is a transient effect.
The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhoea which could be fatal. If acute diarrhoea is observed, discontinue use of this antimicrobial and initiate appropriate therapy.
Milk withdrawal time
Zero hours.
Meat withdrawal time
Animals must not be slaughtered for human consumption during treatment. Cattle and pigs may be slaughtered for human consumption only after the following times from last treatment: |
Cattle: |
1 day | |
Pigs: |
2 days |
Not for use in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
Operator warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure taking all recommended precautions.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Pharmaceutical precautions
Store unreconstituted product in a refrigerator (2°–8°C).
Store reconstituted product in a refrigerator (2°–8°C); any reconstituted product remaining 24 hours after preparation should be discarded.
Protect from light.
Any unused product or waste materials should be disposed with in accordance with national requirements.
For animal treatment only.
Keep out of reach of children.
Legal category
POM-V
Packaging Quantities
Excenel Sterile Powder is supplied as 1 g vials or 4 g vials.
Further information
After recommended dose, therapeutic levels of ceftiofur are achieved within a few minutes and are maintained for at least 24 hours.
Marketing authorisation numbers
|
1 g |
Vm 00057/4228 | |
4 g |
Vm 00057/4226 | Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Pfizer Limited
Address: Ramsgate Road
Sandwich
Kent CT13 9NJ
Telephone: 0845 300 8034 (Out of hours: 01304 616161)
Fax: 01737 332521
Email: UKVetLine@pfizer.com
Website: www.pfizerah.co.uk
Presentation
Vials containing a powder for solution for injection. Vials contain either 1 g or 4 g ceftiofur as the sterile, freeze-dried sodium salt. Ceftiofur sodium is a white to beige, amorphous powder requiring reconstitution with Water for Injection. Each ml of reconstituted solution contains ceftiofur sodium equivalent to 50 mg ceftiofur.
Uses
Excenel contains ceftiofur which is a beta-lactamase resistant, broad spectrum, bactericidal cephalosporin antibiotic. The product is indicated for:
1.the treatment of cattle with acute respiratory disease in which Pasteurella haemolytica, Pasteurella multocida, Actinobacillus (Haemophilus) somnus or other sensitive bacterial pathogens of the respiratory tract are involved,
2.the treatment of cattle with acute interdigital necrobacillosis (foul in the foot) in which Fusobacterium necrophorum and Bacteroides melaninogenicus are involved. As with all antibiotic therapy, treatment of this condition with Excenel should be instituted as early as possible in order to provide maximum clinical effect.
3.the treatment of pigs with bacterial respiratory disease in which Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida and/or Streptococcus suis are involved,
4.the treatment of horses with bacterial respiratory disease in which Streptococcus spp. (including Streptococcus zooepidemicus and Streptococcus equi), Staphylococcus spp. and/or Pasteurella spp are involved.
Dosage and administration Reconstitution
1 g vial. Reconstitute by adding 20 ml Water for Injection.
4 g vial. Reconstitute by adding 80 ml Water for Injection.
For ease of reconstitution use an 18 gauge needle. Rapid addition of diluent will give best results.
Dosage: Cattle
1 mg/kg bodyweight. This is equivalent to 1 ml of the reconstituted solution per 50 kg bodyweight. For respiratory disease, the dose should be given once daily at 24 hour intervals for 3 to 5 days in total. For foul in the foot, the dose should be given once daily at 24 hour intervals for 3 days in total.
Pigs
3 mg/kg bodyweight. This is equivalent to 1 ml of the reconstituted solution per 16 kg bodyweight. The dose should be given once daily at 24 hour intervals for 3 days in total.
If no response is seen within these periods, the diagnosis should be redetermined.
Horses
2 mg/kg bodyweight. This is equivalent to 2 ml of the reconstituted solution per 50 kg bodyweight. The dose should be given once daily at 24 hour intervals and continued for 48 hours after clinical signs have disappeared. A 10 day treatment period is usually adequate. A maximum of 10 ml solution should be administered per injection site. If no response is seen within 4–5 days, the diagnosis should be redetermined.
Administration
The intramuscular route only should be used in cattle, pigs and horses. In the pig, particular care must be taken to avoid injection into fat tissue. Normal aseptic injection techniques should be practiced.
Contra-indications, warnings, etc
The use of Excenel Sterile Powder is contra-indicated in animals previously found to be hypersensitive to ceftiofur.
The use of the product may cause occasional local discomfort upon injection but this is a transient effect.
The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhoea which could be fatal. If acute diarrhoea is observed, discontinue use of this antimicrobial and initiate appropriate therapy.
Milk withdrawal time
Zero hours.
Meat withdrawal time
Animals must not be slaughtered for human consumption during treatment. Cattle and pigs may be slaughtered for human consumption only after the following times from last treatment:
Cattle:
| 1 day
| Pigs:
| 2 days
|
Not for use in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation. Operator warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure taking all recommended precautions.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use. Pharmaceutical precautions
Store unreconstituted product in a refrigerator (2°–8°C).
Store reconstituted product in a refrigerator (2°–8°C); any reconstituted product remaining 24 hours after preparation should be discarded.
Protect from light.
Any unused product or waste materials should be disposed with in accordance with national requirements.
For animal treatment only.
Keep out of reach of children.
Legal category
POM-V
Packaging Quantities
Excenel Sterile Powder is supplied as 1 g vials or 4 g vials.
Further information
After recommended dose, therapeutic levels of ceftiofur are achieved within a few minutes and are maintained for at least 24 hours.
Marketing authorisation numbers 1 g
| Vm 00057/4228
| 4 g
| Vm 00057/4226
|
| 
