Pharmaceutical Form

            Suspenion for Injection

            A white to off-white aqueous suspension for injection.

      Target species:

            Cattle,Horses,Sheep,Pigs

Indications for use, specifying the target species:

            For the treatment of systemic infections in cattle, horses, sheep and pigs caused by or associated with organisms sensitive to penicillin and/or streptomycin including:

Contraindications:

            Contraindicated in known cases of hypersensitivity to penicillins.

       Special Warnings for Each Target Species:

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

            Do not exceed the recommended dosage or duration of treatment.

        Special Precautions for Use:

            i.    Special precautions for use in animals:

Care should be taken not to exceed the recommended dosage.  Aminoglycosides have a narrower margin of safety than beta lactam antibiotics.

ii.   Special precautions to be taken by the person administering the product to the animals:           

Care should be taken to avoid accidental self-injection.  In the case of accidental self-injection, seek medical advice immediately.

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 reaction 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 in breathing are more serious symptoms and require urgent medical attention. 

Wash hands after use.  

       Adverse reactions (frequency and seriousness): 

Occasionally in sucking and fattening pigs, administration may cause a transient pyrexia, vomiting, shivering, listlessness and in-coordination.

A palpable but transient local reaction may occur at the site of intramuscularadministration in horses.

Amount to be administered and administration route: 

            Shake the vial before use.

            Administer by deep intramuscular injection.

            Recommended dosage rate is 8 mg/kg bodyweight procaine penicillin with 10 mg/kg bodyweight dihydrostreptomycin sulphate equivalent to 1 ml per 25 kg bodyweight.  Treatment should be given once daily for up to 3 consecutive days.  The maximum dose volume administered at one site should not exceed 15 ml for horses, 6 ml for cattle, 3 ml for sheep and 1.5 ml for pigs.  

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

            No treatment specified.

Withdrawal periods: 

            Animals must not be slaughtered for human consumption during treatment. 

            Sheep:

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

            Sheep intended for human consumption should not be slaughtered until 31 days after the last treatment.

            Cattle:

            Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cows after 60 hours from the last treatment.

            Cattle intended for human consumption should not be slaughtered until 23 days after the last treatment. 

            Pigs:

            Pigs intended for human consumption should not be slaughtered until 18 days after the last treatment.  

            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