Presentation

A sterile, aqueous white to off-white suspension for injection containing 300 mg/ml Procaine Benzylpenicillin Ph.Eur. Preservative methylparahydroxybenzoate 1.1 mg/ml.

Uses

For the treatment of infections caused by bacteria sensitive to penicillin in horses, cattle, sheep, pigs, dogs and cats.

Dosage and administration

Horses and cattle 12 mg per kg bodyweight, by intramuscular injection.

Sheep and pigs 15 mg per kg bodyweight, by intramuscular injection.

Dogs and cats 30 mg per kg bodyweight (1 ml per 10 kg bodyweight) by subcutaneous administration.

Clean the area of the injection site and swab with spirit.  Shake well before use.

Treatment may be repeated at intervals of 24 hours for up to 5 administrations.  For organisms highly susceptible to penicillin, such as Streptococcus dysgalactiae in sheep, treatment may be repeated at 48 hour intervals for up to 3 administrations.

DO NOT USE THE SAME INJECTION SITE MORE THAN ONCE DURING A COURSE OF TREATMENT.
Do not inject more than 20 ml per injection site in cattle.

Do not inject more than 5 ml per injection site in pigs and sheep.

Contra-indications, warnings, etc.

Not to be administered to animals sensitive to penicillin.

Not to be used in rabbits, guinea pigs, hamsters or gerbils.  Caution is advised in its use in other small herbivores.

Not effective against beta-lactamase-producing organisms.

Occasionally in sucking and fattening pigs, administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. Additionally in pregnant sows and gilts, a vulval discharge which could be associated with abortion has been reported.

Not recommended for intravenous or intrathecal administration.

Occasional allergies to penicillin have been observed but they are very rare.

Antagonism between the product and bacteriostatic preparations may occur.  Resistant bacteria, particularly gram-negative, that show a cross-resistance with other beta-lactams might occur.

Withdrawal periods:

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken only from cows after 11 days (264 hours) from the last treatment.

Not to be used in sheep producing milk intended for human consumption.

Animals must not be slaughtered for human consumption during treatment. Cattle, pigs and sheep may be slaughtered for human consumption only after 5 days from the last treatment. Not to be used in horses intended for human consumption.

Operator warnings:

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances are occasionally 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 or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

FOR ANIMAL TREATMENT ONLY.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Pharmaceuticalprecautions

Store in a refrigerator at between +2^oC and +8^oC. Do not freeze. Protect from light.

Shake the container well before use.

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

Keep container in outer carton.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V           To be supplied only on veterinary prescription.      

Package quantities

Multidose glass or PET vials of 100 ml.

Further information

Nil.

Marketing Authorisation number

Vm 06376/4018       

Marketing Authorisation holder
Intervet International B.V.
Represented in the UK by:
Intervet UK Ltd.               
Walton, Milton Keynes
Buckinghamshire MK7 7AJ 

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation:

February 2008.