White to off-white crystalline powder and clear solution of solvent for suspension for injection.

Each 5 g vial contains: Penethamate hydriodide 5 million IU.

Each 10 g vial contains: Penethamate hydriodide 10 million IU.

Each 15 ml and 30 ml vial of solvent contains: methyl parahydroxybenzoate, as preservative 1.5 mg/ml

Each ml of the reconstituted product contains 269.5 mg of penethamate hydriodide.

Bovine mastitis caused by penicillin sensitive organisms.

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

Shake well after reconstitution.

Dosage: The daily dose is 15 mg Penethamate hydriodide per kg bodyweight for 3 consecutive days. This is equivalent to 5.5 ml of the reconstituted suspension per 100kg bodyweight. Shake well before administration.

For intramuscular use only. Do not administer intravenously.

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under-dosing.

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

Do not administer by intravenous injection.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Official, national and regional antimicrobial policies should be taken into account when the product is used.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to benzylpenicillin and may decrease the effectiveness of treatment with other beta-lactams due to the potential for cross-resistance.

In very rare cases anaphylactic shock may occur, which can be fatal.

Can be used during pregnancy.

Penicillins should not be administered concurrently with bacteriostatic antibiotics.

Penicillins have a very wide margin of safety.

Cattle meat and offal: 7 days

Cattle milk: 96 hours

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.

Wash hands after use. In the event of self-injection, seek medical advice.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after reconstitution according to directions: Use immediately.

Do not store above 25°C

Discard unused suspension.

Keep the container in the outer carton.

Keep out of the reach and sight of children. For animal treatment only.

To be supplied only on veterinary prescription.

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

Colourless, Type I Ph Eur glass vials, closed with butyl rubber stoppers and metal caps containing either 5 or 10 g of penethamate hydriodide and 15 or 30 ml solvent to produce a reconstituted suspension. Pack sizes: 10g vials and 30ml solvent x 10 or 5g vials and 15ml solvent x 10. Not all pack sizes may be marketed

Its mode of action is by prevention of cell wall synthesis during bacterial cell growth and is primarily bactericidal. The in-vitro spectrum of activity is mainly within the gram-positive class of bacteria eg Staphylococcus spp, Streptococcus spp, Clostridium spp, Bacillus spp etc.

Penethamate hydriodide is a prodrug which releases benzylpenicillin quantitatively at hydrolysis. The pKa-value of penethamate hydriodide is 8.4. This means that in aqueous solution at physiological pH of 7.2, 8.2% of the drug will be present as the uncharged molecule while 91.8% will be present as the ion. In aqueous solution penethamate is hydrolysed to form benzylpenicillin and diethylaminoethanol. After intramuscular injection the prodrug itself as well as the released alcohol, diethylaminoethanol has not shown any unexpected pharmacological effects.