Introduction

Company name: Animalcare Limited

Address: Common Road

Dunnington

York YO19 5RU

Telephone: 01904 487687

Fax: 01904 487611

Email: animalcare@animalcare.co.uk

Presentation

A white/off-white suspension for parenteral administration containing Procaine penicillin/Procaine Benzylpenicillin Ph.Eur. 300 mg per ml.

Methyl Hydroxybenzoate 0.112% w/v (as preservative)

Ethyl Hydroxybenzoate 0.023% w/v (as preservative)

Propyl Hydroxybenzoate 0.016% w/v (as preservative)

Uses

Penacare is indicated for use in cattle, sheep and pigs in the treatment of infections caused by or associated with organisms sensitive to penicillin. In vitro tests have shown the following organisms to be sensitive:

Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Listeria spp, Pasteurella haemolytica, Pasteurella multocida, Staphylococcus spp. (non-penicillinase producing) and Streptococcus spp.

Penacare in recommended, therefore, in the treatment of diseases caused by susceptible organisms including:

erysipelas; navel/joint-ill; respiratory tract infection including pneumonia and atrophic rhinitis; listeriosis; septicemia; urogenital tract infections and the control of secondary bacterial invaders in diseases of primary viral origin.

Dosage and administration

Penacare should be administered by the intramuscular route after shaking to ensure resuspension. Normal aseptic precautions should be observed.

The recommended dose rate is:

10 mg procaine penicillin/kg bodyweight (1 ml/30 kg) daily for three to five days

Contra-indications, warnings, etc

Penacare is contra-indicated in known cases of hypersensitivity to penicillins.

Do not inject intravenously or intrathecally.

Occasionally, in sucking and fattening pigs administration of such products may cause a transient pyrexia, vomiting, shivering, listlessness and inco-ordination.

Additionally in pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported.

Care should be taken not to overdose.

Not to be used on very small herbivores such as guinea pigs, gerbils and hamsters.

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

Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cows 84 hours after the last treatment.

Animals must not be slaughtered for human consumption during treatment. Cattle sheep and pigs may be slaughtered for human consumption only after 7 days from the last treatment.

Operator warning – Penicillin/Cephalosporin sensitivity

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 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 type of 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.

Pharmaceutical precautions

Do not store above 25°C.

Protect from light

Keep out of the reach of children

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Legal category

POM-V

Packaging Quantities

Multidose vials of 100 ml.

Further information

When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on the package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written on the space provided on the label

Disposal

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

Marketing authorisation number

2000/4154.