Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Duphacillin is an off-white oily injectable suspension containing 150 mg/ml Ampicillin as Ampicillin Trihydrate.

Uses

Duphacillin is a broad-spectrum semi-synthetic penicillin, bactericidal in action, for use in cattle, sheep and pigs. In vitro it is effective against a wide range of Gram-positive and Gram-negative pathogenic bacteria including: Bordetella bronchiseptica, Arcanobacterium pyogenes, Erysipelothrix rhusiopathiae, Mannheimia haemolytica, Pasteurella multocida, Salmonella spp, non penicillinase producing Staphylococcus spp, and Streptococcus spp.

Duphacillin 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; meningitis; septicaemia; urogenital tract infections and the control of secondary bacterial invaders in diseases of primary viral origin.

Duphacillin will also have some effect in the treatment of enteritis caused by Salmonella species.

Dosage and administration

By intramuscular injection, after shaking the vial to ensure suspension of active material, at a dosage rate of 7.5 mg/kg bodyweight (1 ml/20 kg) once daily for up to five days.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

As with other penicillins, Duphacillin should not be administered to penicillin sensitive animals or small herbivores such as gerbils, guinea pigs, hamsters and rabbits.

Although normally non‑irritant, Duphacillin may occasionally cause local reaction at the site of injection.

Withdrawal periods

Milk for human consumption must not be taken from a cow during treatment. Milk for human consumption may only be taken after 24 hours from the last treatment.

Not for use in sheep producing milk 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 18 days from the last treatment.

Operator warning

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross reactions to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.

1.Do not handle this type of 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.

4.Wash hands after use.

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Shake vial before use. Use a dry, sterile needle and syringe. Keep out of the reach and sight of children. This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Following withdrawal of the first dose, use the product within 28 days. When the container is broached for the first time, using the in-use shelf-life which is specified on this data sheet, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label. Discard unused material. Keep container in outer carton.

Legal category

POM-V

Packaging Quantities

Multidose vials of 50 ml and 100 ml.

Further information

To ensure that the product is administered by deep intramuscular injection, a needle of appropriate length should be used.

As Salmonella species show variable susceptibility to ampicillin, sensitivity testing is recommended prior to treatment.

Disposal

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

Marketing authorisation number

Vm 01596/4178