Mamyzin 269.5 mg/ml powder and solvent for suspension

Mamyzin 269.5 mg/ml powder and solvent for suspension for injection.

Presentation

Powder and solvent for suspension for injection. Vial containing 5 g or 10 g Penethamate hydriodide powder. A second vial contains 15 ml or 30 ml sterile diluent containing 1.5 mg per ml methylparahydroxybenzoate as preservative.

Use only 5 g vial with 15ml diluent and 10 g vial with 30 ml diluent to provide the correct dose.

Uses

For the treatment of mastitis in dairy cows caused by penicillin sensitive organisms.

Penethamate hydriodide is a prodrug which releases benzyl penicillin on hydrolysis. The in-vitro spectrum of activity is mainly within the Gram-positive class of bacteria e.g. Staphylococcus spp., Streptococcus spp., Clostridium spp., Bacillus spp.

Dosage and administration

Reconstitution: Reconstitute the suspension using the entire contents of the 5g vial and 15 ml vial of diluent provided OR the 10g vial and 30ml vial of diluent provided. Shake well after reconstitution.

Dosage: The dose is 10-15 mg Penethamate hydriodide per kg bodyweight. This is equivalent to 3.5 - 5.5 ml of the reconstituted suspension per 100kg bodyweight. Shake well before administration.

The injection can be repeated at intervals of 24 hours for up to 4 days in total.

For intramuscular use only. Do not administer intravenously.

Contra-indications, warnings, etc

Do not use in animals known to be hypersensitive to penicillin.

Do not administer by intravenous injection.

Can be used during pregnancy.

Should not be administered concurrently with bacteriostatic antibiotics.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 7 days from the last treatment.

Milk for human consumption must not be taken from cows during treatment. Milk for human consumption may only be taken 108 hours from the last treatment.

Therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

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

(3) If you develop symptoms following exposure such as 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.

In the event of self-administration seek medical advice.

Unused product and containers should be disposed of in accordance with national requirements.

For animal treatment only.

Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C

After reconstitution, use immediately. Discard unused suspension.

Keep the container in the outer carton.

Legal category

POM-V

Packaging Quantities

Pack sizes:

10g vials and 30ml solvent x 10

5g vials and 15ml solvent x 10

Not all pack sizes may be marketed