Clinical Particulars

       Target species:

     Cattle, sheep and pigs.

        Indications for use, specifying the target species:

                   The product is indicated for use in cattle, sheep and pigs in the treatment of:

            - Atrophic rhinitis caused by Bordetella bronchiseptica, Mannheimia haemolytica and Pasteurella multocida.

            - Navel/joint ill caused by Arcanobacterium pyogenes, E. coli or Staphylococcus aureus.

            - Mastits caused by Corynebacterium pyogenes, E. coli, Staphylococcus aureus, Streptococcus agalactiae or Streptococcus uberis.

            - Metritis caused by E. coli or Streptococcus pyogenes.

            - Pasteurellosis and infections of the respiratory tract caused by Mannheimia haemolytica and Pasteurella multocida.

            - Septicaemia caused by Salmonella dublin and Streptococcus pyogenes.

            - Erysipelas caused by Erysipelothrix rhusiopathiae.

            The product can also be used in the control of enzootic abortion in sheep.

  Contraindications:

            Not for use in horses, dogs, cats.

            Not for use in animals suffering from hepatic or renal damage.

       Special Warnings for Each Target Species:

            No special warnings.

       Special Precautions for Use:

            Special Precautions for use in animals:

            Do not dilute the product.

            If concurrent treatment is administered, use a separate injection site.

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

            Wash hands after use.  In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur.

Take care to avoid accidental injection

       Adverse reactions (frequency and seriousness):

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

  Use during pregnancy, lactation or lay:

            The use of oxytetracycline during the period of tooth and bone development, including late pregnancy may lead to tooth discoloration, the product can be safely administered to lactating animals.

      Interactions with other medicinal products and other forms of interaction:

            None known.

       Amount to be administered and administration route:

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

            Maximum recommended dose at any one site:

            Cattle      :      20ml

            Pigs  :      10ml

            Sheep      :      5ml

            Piglets     :      1 day 0.2ml

                                   7 days 0.3ml

                                   14 days 0.4ml

                                   21 days 0.5ml

                     over       21 days 1.0 ml/10kg.

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

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

4.11     Withdrawal periods:

            Cattle:            Meat – 31 days

                                   Milk – 10 days

            Sheep:            Meat – 9 days

                                   Milk – 7 days

            Pigs:               Meat – 18 days

         Pharmacological Properties

            Pharmacotherapeutic group: Antibiotic

            ATCvet Code: QJ01AA06

      Pharmacodynamic properties:

            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.  The product is specifically formulated to provide a prolonged action resulting in sustained antibacterial activity.

Oxytetracycline had been shown to be effective in vitro against the following bacterial species: Bordetella bronchiseptica, Corynebacterium pyogenes, Erysipelothrix rhusiopathiae, Escherichia coli, Haemophilus somnus, Pasteurella haemolytica, Pasteurella multocida, Salmonella dublin, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes and Streptococcus uberis.

       Pharmacokinetic properties:

            Blood levels persist for at least 4 days after administration by the intramuscular route.  Maximum blood levels are achieved between 4 and 8 hours following intramuscular administration.

         Pharmaceutical Particulars

              List of excipients:

Sodium formaldehyde sulphoxylate dihydrate

Magnesium Oxide Light

Dimethylacetamide

Disodium Edetate Dihydrate

Ethanolamine

Water for Injections

       Incompatibilities:

            None Known.

       Shelf-life:

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

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

       Special precautions for storage:

            Do not store above 25oC.  Protect from light.

            Following withdrawal of the first dose, use the product within 28 days.

            Discard unused material

            When the vial has been broached and contents exposed to air, the solution may darken but the potency will be unchanged.