SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Duphapen Fort 300 mg/ml Suspension for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Procaine Benzylpenicillin 30% w/v [300 mg/ml]

Excipient(s):

Butyl hydroxytoluene 0.007% w/v

Butyl Hydroxanisole 0.007% w/v

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

A sterile white/off-white suspension for injection containing 300 mg procaine

penicillin G per ml in a long-acting oily base.

4. CLINICAL PARTICULARS

Cattle

Pigs

The product is specifically formulated to provide sustained antibacterial activity following a single administration.

It is indicated for use in cattle and pigs for the treatment and control of a wide range of common systemic, respiratory, urinary and local infections caused by or associated with organisms sensitive to penicillin, including Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Mannheimia haemolytica, Pasteurella multocida and Streptococcusspp.

The product 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 primarily of viral origin.

4.3 Contraindications

Do not use in known cases of hypersensitivity to penicillins.

Do not inject intravenously.

Do not use on very small herbivores such as guinea pigs, gerbils and hamsters.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Shake the vial before use.

This product does not contain an antimicrobial preservative.

Swab the septum before removing each dose.

Use a dry, sterile needle and syringe.

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.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure, taking all recommended precautions.

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.

4.6 Adverse reactions (frequency and seriousness)

Occasionally in suckling and fattening pigs administration of 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.

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

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

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

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Indicated for intramuscular and subcutaneous administration to non-lactating cattle and for intramuscular administration only to pigs and lactating cattle.

The recommended dose rate is 20 mg procaine penicillin per kg bodyweight equivalent to 1 ml per 15 kg bodyweight. If signs persist at 72 hours repeat the dose.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Betalactam antibiotics have a wide margin of safety and even overdose is unlikely to cause clinical signs.

4.11 Withdrawal periods

Subcutaneous Administration

Cattle: Meat - 13 days.

Intramuscular Administration

Cattle: Meat - 23 days.

Pigs: Meat - 10 days.

Cattle: Milk - 132 hours.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:Antibacterials for systemic use, Beta-lactam antibacterials, penicillins, Beta-lactamase sensitive penicillins.

ATC Vet Code:QJ01CE09

Penicillin G is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins.

Penicillin G shows excellent activity against susceptible Gram-positive bacteria such as Streptococci, Corynebacterium, Erysipelothrix andClostridia but has limited activity against Gram-negative bacteria with the exception of the more fastidious Gram-negative aerobes such as Pasteurellaspp.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross- linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis only of growing cells.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butyl hydroxytoluene

Butyl Hydroxanisole

Aluminium distearate

Propylene glycol dicaprylate/dicaprate

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 28 days

6.4. Special precautions for storage

Do not store above 25 °C

Protect from light

6.5 Nature and composition of immediate packaging

Supplied in 50 ml and 100 ml Type II clear glass vials, complete with nitryl bungs and aluminium caps.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4047

9. DATE OF FIRST AUTHORISATION

Date:17 July 1998

10. DATE OF REVISION OF THE TEXT

Date:April 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

03 April 2014