NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Monday, June 24, 2024 10:29

Release 2.94
Terramycin/LA 200 mg/ml Solution for Injection
 
Species: Cattle, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Oxytetracycline Dihydrate
Product:Terramycin®/LA
Product index: Terramycin/LA
Cattle - milk: 7 days
Cattle - meat: 36 days
Sheep - meat: 24 days
Pig - meat: 36 days
Incorporating:
Presentation
Terramycin/LA 200 mg/ml Solution for Injection is a concentrated, sterile, clear, yellow to amber, stable, ready to use solution containing Oxytetracycline Dihydrate equivalent to 200 mg oxytetracycline base per ml as the magnesium complex in an aqueous solution.
Uses
Terramycin/LA 200 mg/ml Solution for Injection is a solution of oxytetracycline specially formulated to give long acting effect when given by intramuscular injection.
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.
Sheep
For the control of enzootic abortion and pneumonia caused by oxytetracycline-sensitive organisms. The product may be used as an aid in the treatment of foot rot, acute severe mastitis and infectious ovine keratoconjunctivitis (pink-eye).
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). In cattle not more than 10 ml, and in sheep and pigs not more than 5 ml to be given at any one site.
In pigs weighing less than 10 kg a 1 ml dose should be used.
Contra-indications, warnings, etc
Not recommended for cats, dogs or horses.
Use with caution in animals with hepatic or renal involvement.
Concomitant vaccination is not recommended.
Do not combine with bactericidal antimicrobial products or with infusion fluids.
Oxytetracycline may interfere with the action of bactericidal antimicrobials, such as penicillins and cephalosporins, and therefore they should not be used simultaneously.
Local reactions at the injection site may occur.
In very rare cases, hypersensitivity, allergic or anaphylactic type reactions may occur. In case of a serious anaphylactic reaction the administration of appropriate treatment (epinephrine, adrenaline, steroids, antihistamines, Ca) is recommended.
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.
If concurrent treatment is administered use a separate injection site.
Resistance against oxytetracycline may vary.
Use of the product should be based on susceptibility testing of 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. Inappropriate use of the product may increase the prevalence of bacteria resistant to oxytetracycline and may decrease the effectiveness of treatment with tetracyclines due to the potential for cross resistance.
Withdrawal periods
Meat: Cattle: 36 days. Pigs: 36 days. Sheep: 24 days.
Milk: Cattle: Milk for human consumption must not be taken during treatment. Milk from cows may only be taken for human consumption after 7 days from the last treatment.
Not for use in ewes producing milk for human consumption.
User warnings
This product may cause hypersensitivity reactions (allergy). Persons with a known hypersensitivity to tetracyclines should not handle this product.
Wash hands after use.
In case of contact with eyes or skin, wash off immediately with water as irritation may occur. Avoid accidental self-injection.
Pharmaceutical precautions
Do not store above 25°C.
The product will freeze at –2°C but, on thawing, reverts completely to its original condition.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material. Contamination of broached vials should be avoided.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Multi-dose vial of 100 ml.
Further information
Terramycin/LA 200 mg/ml Solution for Injection 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.
Terramycin/LA can be used during pregnancy and lactation, but not in ewes producing milk for human consumption.
Marketing Authorisation Number
Vm 42058/4151
Significant changes
GTIN
GTIN description:100 ml:
GTIN:05013457070170