TERRAMYCIN

Presentation Terramycin/LA Injectable Solution is a concentrated, sterile, clear, yellow to amber, stable, ready to use solution containing Oxytetracycline Dihydrate PhEur equivalent to 200 mg oxytetracycline base per ml as the magnesium complex in an aqueous solution Uses Terramycin/LA Injectable Solution is a solution of oxytetracycline specially formulated to give long acting effect when given by intramuscular injection. Terramycin/LA Injectable Solution may also be used by intravenous injection in cattle. Intravenous administration does not give long acting effect. Terramycin is a broad spectrum antibiotic, and is indicated for the treatment and control of conditions caused by, or associated with, oxytetracycline-sensitive organisms. A large number of Gram-positive and Gram-negative bacteria, certain mycoplasma species, rickettsiae, protozoa and the chlamydiae are sensitive to oxytetracycline. Indications Cattle For the treatment and control of pasteurellosis and pneumonia caused by oxytetracycline sensitive organisms and as an aid in the treatment of infectious bovine keratoconjunctivitis (New Forest Disease), due to oxytetracycline sensitive strains of Moraxella bovis . The product may also be of value for foul-in-the-foot. Pigs For the treatment of pneumonia caused by Pasteurella and the control of atrophic rhinitis. Sheep For the control of enzootic abortion and pneumonia caused by oxytetracycline-sensitive organisms. The product may be an aid in the treatment of foot rot, acute severe mastitis, infectious ovine keratoconjunctivitis (pink-eye) and, in lambs, of tick-borne fever. It may also be of value in the treatment of tick pyaemia in lambs. Red deer May be used as an aid in the control of yersiniosis in deer. Dosage and administration For long acting effect Terramcyin/LA should be given by deep intramuscular injection at a rate of 20 mg equivalent of oxytetracycline base/kg bodyweight (ie 1 ml Terramycin/LA Injectable Solution per 10 kg bodyweight). It is recommended that in cattle and pigs not more than 10 ml, and in sheep and red deer not more than 5 ml be injected at any one site. In pigs weighing less than 10 kg a 1 ml dose should be used, which may be given subcutaneously. For atrophic rhinitis, a 0.5 ml dose is recommended at 3 days of age followed by a 1 ml dose at 12 and 21 days of age. In young lambs for the treatment of tick pyaemia and as an aid in the treatment of tick-borne fever, a 2 ml dose is recommended per lamb. For intravenous injection of cattle a dosage rate of 10 mg/kg bodyweight is recommended. The use of Terramycin/LA intravenous route permits low volume injections but does not give long acting effect. Following an initial intravenous injection of Terramycin/LA, treatment may be continued after 24 hours with a single long-acting intramuscular injection at 20 mg/kg. Alternatively treatment may be continued with daily intramuscular injections of Terramycin Q-100 at 10 mg/kg; a total course of treatment of 3–5 days is usually sufficient but may be varied at the veterinary surgeon's discretion. Contra-indications, warnings, etc Animals must not be slaughtered for human consumption during treatment. Cattle, sheep and pigs may be slaughtered for human consumption only after 21 days from the last treatment. Red deer may be slaughtered for human consumption only after 30 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 from cows after 7 days from the last treatment. Not for use in ewes producing milk for human consumption. Not recommended for cats, dogs or horses. Not to be injected subcutaneously except in piglets under 10kg bodyweight. Use with caution in animals with hepatic or renal involvement. Concomitant vaccination is not recommended. Intravenous administration in cattle should be performed slowly as rapid injection may result in collapse. Do not combine with bactericidal antimicrobial products or with infusion fluids. Local reactions at the injection site may occur. Bacterial resistance may exist or develop after prolonged use of tetracyclines. The use of tetracyclines during the period of tooth development, including late pregnancy, may lead to tooth discolouration. Do not dilute. The period of time between the withdrawal of the first and last dose from a multi-dose vial should not be longer than 28 days. Discard unused material. Contamination of broached vials should be avoided. Wash hands after use. Keep out of reach of children. Pharmaceutical precautions Do not store above 25°C. The product will freeze at –2°C but, on thawing, reverts completely to its original condition. Unused product or waste material should be disposed of in accordance with any guidance from an appropriate waste regulation authority. Legal category POM-V (previously POM). Packaging Quantities Multi-dose vial of 100 ml. Further information Terramycin/LA Injectable Solution is stable for two years from date of manufacture if stored as directed. The preparation may darken on exposure to air but the potency of the Terramycin remains unchanged. Following intramuscular injection oxytetracycline is rapidly absorbed into the blood with high peak blood levels being reached within 4 hours. Oxytetracycline is also slowly released from the depot at the injection site giving rise to a prolonged action lasting 3 – 5 days after a single injection. Oxytetracycline is concentrated in respiratory and ocular tissues. Marketing authorisation number Vm 00057/4085.