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 Trueperella 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
Do not use in horses, dogs, cats. Do not 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.
Resistance against oxytetracycline may vary. Use of the product should be based on susceptibility testing and taking into account official and local antimicrobial policies.
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.
Special precautions to be taken by the person administering the product to the animals
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 immediately with plenty of water as irritation may occur.
Take care to avoid accidental injection.
Adverse reactions (frequency and seriousness)
Local reactions at the injection site may occur.
Collapse has been reported with tetracyclines in weak or debilitated animals. Other adverse reactions to oxytetracycline that have been observed include gastrointestinal disorders and, less frequently, allergic and photosensitivity reactions.
In very rare cases, hypersensitivity, allergic or anaphylactic type reactions may occur. If such reactions occur, appropriate treatment is recommended.
The frequency of adverse reactions is defined using the following convention:
•very common (more than 1 in 10 animals treated displaying adverse reaction(s))
•common (more than 1 but less than 10 animals in 100 animals treated)
•uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
•rare (more than 1 but less than 10 animals in 10,000 animals treated)
•very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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
Oxytetracycline may interfere with the action of bactericidal antimicrobials, such as penicillins and cephalosporins, and therefore they should not be used simultaneously.
Concomitant vaccination is not recommended because of possible immunosuppressive activity of tetracyclines.
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.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
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.
Overdose (symptoms, emergency procedures, antidotes) (if necessary)
There is no known specific antidote, if signs of possible overdose occur, treat the animal symptomatically.
Withdrawal periods
Cattle:
•Meat – 41 days
•Milk – 8 days
Sheep:
•Meat – 24 days
•Milk – 7 days
Pigs:
•Meat – 20 days