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.only4vets.co.uk
Synulox Bolus 500 mg film-coated tablet
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.only4vets.co.uk
Presentation
Synulox Bolus 500 mg film-coated tablets are presented as large, pink, film-coated, bolus-shaped tablets, with a break line on one side and 'SYNULOX' engraved on the other. Each bolus contains 100 mg clavulanic acid as potassium clavulanate and 400 mg amoxicillin as Amoxicillin trihydrate.
Uses
Synulox boluses have a notably broad spectrum of bactericidal activity against bacteria commonly found in calves.
In vitro Synulox is active against a wide range of clinically important bacteria including:
Gram-positive: | Staphylococci (including β-lactamase producing strains); Streptococci; Corynebacteria; Clostridia; Actinomyces bovis. |
Gram-negative: | Escherichia coli (including β-lactamase producing strains); Salmonellae (including β-lactamase producing strains); Klebsiellae; Proteus spp.; Pasteurellae; Fusobacterium spp.; Haemophilus spp. |
The clinical indications for Synulox boluses are in the treatment of enteritis and navel ill in calves.
Dosage and administration
Administration
By the oral route.
Dosage rate
6.25–12.5 mg/kg bodyweight twice daily, e.g. a 40 kg calf will require ½ bolus twice daily, but this may be doubled in cases of severe infection.
Treatment should be continued for up to 12 hours after the clinical signs have subsided to a maximum of 3 days of treatment.
Contra-indications, warnings, etc
Animals must not be slaughtered for human consumption for 9 days following the last treatment.
Do not use in animals with known sensitivity to the active ingredients.
In common with other penicillins, the product should not be administered orally to rabbits, guinea pigs, hamsters or gerbils.
The combination is of a low order of toxicity and is well tolerated by the oral route. Limited overdose normally produces no adverse effects.
Operator warning
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reaction to cephalosporins and vice-versa. Allergic reaction 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. Wash hands after use.
3.If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and may require urgent medical attention.
Pharmaceutical precautions
Do not store above 25°C. Store in a dry place.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V
Packaging Quantities
Packs containing 20 and 100 boluses.
Further information
Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in Synulox counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the organisms sensitive to amoxicillin's rapid bactericidal effect.
Synulox is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.
Marketing authorisation number
Vm 00057/4186.
Significant Changes
Change in withdrawal period | 14/03/2007 |