White to off white intramammary suspension. Each 4.5 g intramammary syringe contains the following active ingredients: Penethamate Hydriodide 100 mg (equivalent to 77.2 mg penethamate), Benethamine Penicillin 280 mg (equivalent to 171.6 mg penicillin) and Framycetin sulphate 100 mg (equivalent to 71.0 mg framycetin).

Target species: Cattle (at drying off).

For treatment of subclinical mastitis at drying off, and the prevention of new bacterial infections of the udder during the dry period in dairy cows, caused by bacteria susceptible to penicillin and framycetin.

Intramammary administration of 100 mg penethamate hydriodide, 280 mg benethamine penicillin and 100 mg framycetin sulphate into each quarter, i.e. the contents of one syringe to be infused into each quarter immediately after the last milking of a lactation.

Before infusion, the teats should be thoroughly cleaned and disinfected, and care should be taken to avoid contamination of the injector nozzle. Following infusion, it is advisable to use a teat wipe or spray.

Do not use in lactating cows.

Do not use in case of hypersensitivity to the active substances or to any of the excipients.

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 and local antimicrobial policies should be taken into account when the product is used.

Serious acute mastitis [potentially lethal] due to pathogens like Pseudomonas aeruginosa, can occur after drying off despite preventive treatment. Good aseptic practices should be thoroughly respected in order to reduce that risk; cows should be housed in a hygienic paddock far from the milking parlour and regularly checked several days after drying off.

Do not use during lactation. Can be used during pregnancy.

Adverse reactions: None known.

Overdose: No data available.

Cattle (meat and offal) : 10 days

Cattle (milk) : If treated at least 35 days before calving, milk must not be used for 36 hours after calving. If treated less than 35 days before calving, milk must not be used for 37 days after treatment.

Skin sensitisation may occur in persons handling the product; care should be taken to avoid contact with skin.

Penicillins and cephalosporins may cause hypersensitivity 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.

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

Do not store above 25°C.

To be supplied only on veterinary prescription.

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

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

Cardboard box or plastic container containing 20, 60 or 120 single use intramammary syringes and 20, 60 or 120 teat wipes (containing isopropanol 70 %). Each 4.5 g syringe (cylinder with piston and cap, all made of low density polyethylene) contains 5 ml intramammary suspension. Not all pack sizes may be marketed.

Benethamine benzylpenicillin is the N-benzyl-2phenylethylamine salt of benzylpenicillin, designed as a long-acting formulation of benzylpenicillin. Penethamate is a prodrug from which benzylpenicillin and diethylaminoethanol are released by hydrolysis. Antimicrobial activity is derived exclusively from benzylpenicillin.

The free benzylpenicillin is effective chiefly against a variety of Gram-positive pathogens, excluding β-lactamase producing staphylococci. Penicillins act bactericidally on proliferating micro-organisms by inhibiting cell wall synthesis. The antibacterial activity is time dependent.

Framycetin, also known as neomycin B, is a bactericidal aminoglycoside antibiotic. Inhibition of bacterial protein synthesis and presumed interference with permeability at the cell membrane play a role in effecting bacterial cell death. Its action spectrum encompasses numerous Gram-negative and some Gram-positive bacteria.

In vitro efficacy of the combination of benzylpenicillin and framycetin has been demonstrated against: Staphylococcus spp., Streptococcus spp., Arcanobacterium spp. (Corynebacterium spp.), Escherichia coli, Klebsiella spp. and Pseudomonas spp.

The penicillin components of the product will remain in the dry udder for up to 3 weeks. In the majority of cows the framycetin components will remain in the dry udder for 10 weeks, or until calving.