A clear amber solution for injection containing 200 mg/ml oxytetracycline (as dihydrate). (Equivalent to 216 mg/ml oxytetracycline dihydrate)

Cattle, sheep and pigs.

The product is indicated for the treatment of infections caused by oxytetracycline susceptible bacteria in cattle, sheep and pigs as follows:

Cattle:

Pasteurellosis and respiratory tract infections caused by Mannheimia haemolytica or Pasteurella multocida.

Umbilical infections and septic arthritis caused by Trueperella pyogenes, Escherichia coli or Staphylococcus aureus.

Clinical Mastitis caused by Trueperella pyogenes, Escherichia coli, Staphylococcus aureus, Streptococcus agalactiae or Streptococcus uberis.

Metritis caused by Escherichia coli

Sheep:

Pasteurellosis and respiratory tract infections caused by Mannheimia haemolytica or Pasteurella multocida.

Umbilical infections and septic arthritis caused by Trueperella pyogenes- or Escherichia coli.

Clinical Mastitis caused by Trueperella pyogenes, Escherichia coli or Staphylococcus aureus.

Erysipelas caused by Erysipelothrix rhusiopathiae.

The product can also be used for treatment and metaphylaxis of enzootic abortion in sheep caused by Chlamydophila abortus.

Pigs:

Pasteurellosis and respiratory tract infections caused by Mannheimia haemolytica or Pasteurella multocida.

Umbilical infections and septic arthritis caused by Trueperella pyogenes, Escherichia coli or Staphylococcus aureus.

Clinical Mastitis caused by Escherichia coli.

Erysipelas caused by Erysipelothrix rhusiopathiae.

Atrophic rhinitis caused by Bordetella bronchiseptica or Pasteurella multocida.

The product is to be administered by deep intramuscular injection. The recommended dose rate is 20 mg/kg bodyweight ( 1 ml per 10 kg bodyweight ). The product is recommended for a single administration only.

The cap may be safely punctured up to 35 times. When treating groups of animals, use a draw-off needle.

Maximum volume to be administered per injection site:

Cattle : 20ml

Pigs : 10ml

Sheep : 5ml

Do not use in horses, dogs and cats.

Do not use in animals with hepatic or renal damage.

Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.

None.

Do not dilute the product

If concurrent treatment is administered, use a separate injection site

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.

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

This product may cause sensitisation.

People with known hypersensitivity to tetracyclines, such as oxytetracycline, should avoid contact with the product.

This product may cause skin and eye irritation.

Avoid contact of the skin and eyes with the product. In case of accidental spillage onto skin or eyes, rinse the affected area with large amounts of water.

Take care to avoid accidental injection. In case of self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

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

Tetracyclines have also been associated with photosensitivity reactions and, rarely, hepatotoxicity and blood dyscrasias.

Oxytetracycline given to young animals can cause a yellow, brown or grey discolouration of bones and teeth. High dose or chronic administration may delay bone growth or healing.

The product can be safely administered to lactating animals.

The active substance, oxytetracycline, readily crosses the placenta and concentrations in the foetal blood may reach those of the maternal circulation, although the concentration is usually somewhat lower. Tetracyclines are deposited in teeth, causing discolouration, enamel hypoplasia and reduced mineralisation. Tetracyclines can also retard foetal skeletal development. As such, the product should only be used in the last half of pregnancy following risk benefit assessment by the responsible veterinarian.

Oxytetracycline is excreted in milk; concentrations are generally low.

Oxytetracycline should not be administered simultaneously with bactericidal antimicrobials, such as penicillins and cephalosporins.

Divalent or trivalent cations (Mg, Fe, Al, Ca) can chelate tetracyclines.

There is no known specific antidote, if signs of possible overdose occur treat the animal symptomatically.

Meat and offal: 31 days

Milk: 10 days

Meat and offal: 9 days

Milk: 7 days

Meat and offal: 18 days

Oxytetracycline is a bacteriostatic antibiotic that inhibits protein synthesis in susceptible bacteria. Inside the cell it binds irreversibly to receptors on the 30S subunit of the bacterial ribosome where it interferes with the binding of the aminoacyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex. This effectively prevents the addition of amino acids to the elongating peptide chain, inhibiting protein synthesis.

Oxytetracycline had been shown to be active in vitro against the following bacterial species: Bordetella bronchiseptica, Trueperella pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Mannheimia haemolytica, Pasteurella multocida, Staphylococcus aureus, Streptococcus agalactiae, and Streptococcus uberis.

Multiple genes have been identified which mediate resistance to tetracyclines and these genes may be carried on plasmids or transposons between both pathogenic and non-pathogenic bacteria. The most common mechanisms of resistance involve either the removal of the antibiotic from the organism by energy dependent efflux pumps or protection of the ribosome from binding by altered target sites. Resistance to one tetracycline confers cross-resistance across the whole group.

Oxytetracycline resistance has been identified in many veterinary pathogens; however, the prevalence of resistance varies widely between different locations. For veterinary isolates, the susceptible breakpoint is ≤ 2 µg/mL for bovine respiratory pathogens and ≤ 0.5 µg/mL for swine pathogens. For other isolates, the breakpoint for sensitive organisms in humans is used, which is ≤ 4 µg/mL for all organisms, except streptococci, which is ≤ 2 µg/mL (CLSI, 2007).

Maximum blood levels are achieved between 4 and 8 hours following intramuscular administration.

Sodium Formaldehyde Sulphoxylate Dihydrate

Magnesium Oxide Light

Dimethylacetamide

Disodium Edetate

Ethanolamine (for pH adjustment)

Hydrochloric Acid, concentrated (for pH adjustment)

Water for Injection

The product should not be mixed with other veterinary medicinal products.

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

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

Do not store above 25ºC.

Keep the vial in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater.

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

Amber type II glass vials of 100 ml sealed with a bromobutyl rubber stopper with aluminium overseals and packaged individually into outer cartons.

Bimeda Animal Health Limited

2 / 3 / 4 Airton Close

Tallaght

Dublin 24

Ireland

Vm 50146/4008