Introduction

FDAH

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A white/off white suspension for injection.

Each ml contains:

Procaine benzylpenicillin

300mg

Butylhydroxyanisole 0.07mg and butyhydroxytoluene 0.07mg as antioxidants in a long acting oily base.

Uses

Duphapen Fort is indicated in the treatment of infections in cattle and pigs caused by, or associated with, organisms sensitive to penicillin including: Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Mannheimia haemolytica, Pasteurella multocida and Streptococcus spp.

Duphapen Fort may be used in the treatment and control of a wide range of common systemic, respiratory, urinary and local infections caused by penicillin-susceptible organisms including:

Erysipelas; navel/joint-ill; respiratory tract infections including pneumonia and atrophic rhinitis; meningitis; septicaemia; urogenital tract infections and the control of secondary bacterial invaders in diseases primarily of viral origin.

Dosage and administration

Intramuscular route: Non-lactating cattle, lactating cattle and pigs.

Subcutaneous route: Non-lactating cattle only.

The recommended dosage rate is 1ml per 15kg bodyweight which is the equivalent of 20mg procaine penicillin per kg bodyweight.

If signs persist at 72 hours repeat the dose.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in known cases of hypersensitivity to penicillin.

Not suitable for intravenous administration.

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

This product does not contain an antimicrobial preservative. Use a dry, sterile needle and syringe. Swab the septum before removing each dose.

Occasionally in suckling and fattening pigs administration of this product 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.

Although Duphapen Fort is well tolerated, occasionally a slight local reaction of a transient nature may be observed.

Withdrawal periods

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows only after 132 hours from the last intramuscular treatment.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 13 days from the last treatment by subcutaneous administration and 23 days following the last intramuscular injection. Pigs may be slaughtered for human consumption only after 10 days from the last treatment.

Operator Warning

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 or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.

4.Wash hands after use.

Pharmaceutical precautions

Shake the vial well before use.

Do not store above 25°C.

Protect from light.

Keep out of the reach and sight of children.

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

When the container is broached for the first time, the date on which any product remaining in the container should be calculated. The discard date should be written in the space provided on the label.

Disposal

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