Introduction

FDAH

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A white/off-white suspension for injection containing Procaine Penicillin 300mg/ml. Also contains mixed hydroxybenzoate esters (as sodium salts) 1.5 mg/ml as preservative.

Uses

Duphapen Injection is indicated for use in cattle, sheep and pigs in the treatment of systemic infections caused by or associated with organisms sensitive to penicillin.

In vitro tests have shown the following organisms to be sensitive: Arcanobacterium pyogenes, Erysipelothrix rhusiopathiae, Listeria, Mannheimia haemolytica, Pasteurella multocida, Staphylococcus spp. (non-penicillinase producing) and Streptococcus spp.

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

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

Dosage and administration

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

The recomended dose rate is:

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

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in known cases of hypersensitivity to penicillins.

Do not inject intravenously or inthrathecally.

Occasionally in suckling 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 to be used on small herbivores such as guinea pigs, gerbils and hamsters.

Care should be taken not to overdose. Not to be used in sheep where the milk is intended for human consumption.

Milk taken from cows during treatment and for 84 hours after treatment must not be used for human consumption.

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 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.

4.Wash hands after use.

Pharmaceutical precautions

Do not store above 25°C. Protect from light.

When the container is broached for the first time, the date on which any product remaining in the container should be discarded should be calculated. A statement of the in-use shelf life of the product is given on this data sheet. This discard date should be written on the space provided on the label.

Keep out of the reach and sight of children. Following withdrawal of the first dose, use the product within 28 days. Discard any unused material.