Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A sterile white aqueous suspension for injection.

Each ml contains:

Procaine Benzylpenicillin (procaine penicillin)	200 mg
Dihydrostreptomycin-Sulphate	250 mg

The product also contains nipasept sodium as antimicrobial preservative and sodium formaldehyde sulphoxylate dihydrate as antioxidant.

Uses

Duphapen+Strep is indicated for use in cattle, horses, sheep and pigs for the treatment of infections caused by, or associated with, organisms sensitive to penicillin and/or streptomycin including:

Corynebacterium pyogenes, Erysipelothrix rhusiopathiae, Klebsiella pneumoniae, Listeria spp, Mannheimia haemolytica, Pasteurella multocida, Staphylococcus spp, Streptococcus spp, and Salmonella spp.

Duphapen+Strep will therefore be effective in the treatment of infections caused by susceptible organisms including: Erysipelas, navel/joint-ill, respiratory tract infections, including pneumonia and atrophic rhinitis, listeriosis, meningitis, septicaemia, toxaemia associated with mastitis, urogenital tract infections, enteritis associated with Salmonella spp, salmonellosis and the control of secondary bacterial invaders in diseases of primary viral origin.

The combination of penicillin and dihydrostreptomycin is especially useful in the treatment of mixed infections involving both Gram-positive and Gram-negative organisms.

Dosage and administration

Shake the vial well before use.

Duphapen+Strep should be administered by intramuscular injection.

Normal aseptic precautions should be observed.

The recommended dose rate for cattle, horses, pigs and sheep is 8 mg procaine penicillin and 10 mg dihydrostreptomycin sulphate per kg bodyweight achieved by administering 1 ml per 25 kg bodyweight once daily for up to 3 consecutive days. The maximum dose volume administered at one site should not exceed 15 ml for horses, 6ml for cattle, 3ml for sheep and 1.5ml for pigs.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in known cases of hypersensitivity to penicillin.

Not suitable for intravenous or intrathecal administration.

Occasionally in suckling and fattening pigs, administration of this product may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. A mild transient local reaction may occur at the site of injection in horses. Additionally, in pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported.

Do not administer with other antibiotics such as tetracyclines or with other aminoglycosides.

Use with care in animals known to have kidney disease or defective renal function.

Do not exceed the recommended dosage or duration of treatment.

Animals must not be slaughtered for human consumption during treatment.

Cows: Milk: 60 hours.

Milk must not be taken during treatment.

Meat: 23 days.

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

Meat: 31 days.

Pigs: Meat: 18 days.

Horses: Not to be used in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

Operator warnings

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.

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.

Legal category

POM-V

Packaging Quantities

Multidose vials of 100 ml.

Further information

Disposal:

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

Marketing authorisation number

Vm 01596/4138.