Target species
Cattle and pigs.
Indications for use
Cattle: For the treatment of respiratory infections caused by oxytetracycline susceptible organisms such as Arcanobacterium (Actinomyces) pyogenes and Haemophilus somnus.
Pigs: For the treatment of respiratory infections caused by oxytetracycline susceptible organisms such as Pasteurella multocida.
Contraindications
Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.
Do not use in animals with an impaired liver and/or kidney function.
Special precautions for use in animals
For the 250 ml pack, the use of a multidose syringe is recommended. To refill the syringe, the use of a draw off needle is recommended to avoid excessive broaching of the stopper.
It is recommended to use the veterinary medicinal product in the early stages of disease and to evaluate the response to treatment within 72 hours. Resistance against oxytetracycline may vary. Use of the veterinary medicinal 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.
Because oxytetracycline can retard foetal skeletal development and may cause discoloration and enamel hypoplasia of foetal teeth, the veterinary medicinal product should be used cautiously in the last half of pregnancy.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with a known hypersensitivity to tetracyclines should avoid contact with the veterinary medicinal product.
The direct or indirect contact of the user via skin or mucosa should be avoided because of the risk of sensitisation. Wash hands after use. In case of contact with eyes or skin, wash immediately with water as irritation may occur.
Laboratory studies in rabbits and rats conducted with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.
Adverse reactions
GB:
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reaction (including anaphylaxisa) Hepatic toxicosis, Haematologic effects |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site reactionsb |
Undetermined frequency (cannot be estimated from the available data) | Photosensitivityc Decreased milk productiond |
a Which may be fatal. In case of a serious anaphylactic reaction in cattle the administration of epinephrine, antihistamines and corticosteroids should be considered.
b Transient swelling and/or yellow staining (and local necrosis) will occur following intramuscular administration. Swelling will be visible for several days after injection.
c When exposed to intensive sunlight, particularly treated animals with poor skin pigmentation. d Small drop in lactating animals for up to 3 days following injection.
Pigs:
Rare (1 to 10 animals / 10,000 animals treated): | Hepatic toxicosis, Haematologic effects |
Undetermined frequency (cannot be estimated from the available data) | Photosensitivitya , Injection site reactionsb, Decreased milk productionc |
a When exposed to intensive sunlight, particularly treated animals with poor skin pigmentation.
b Transient swelling and/or yellow staining (and local necrosis) will occur following intramuscular administration. Swelling will be visible for several days after injection.
c Small drop in lactating animals for up to 3 days following injection.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for contact details.
NI:
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reaction including anaphylaxisa, Hepatic toxicosis, Haematologic effects |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site swelling, injection site reaction (yellow discolouration), injection site necrosisb |
Undetermined frequency (cannot be estimated from the available data) | Photosensitivityc, Decreased milk productiond |
Pigs:
Rare (1 to 10 animals / 10,000 animals treated): | Hepatic toxicosis, Haematologic effects |
Undetermined frequency (cannot be estimated from the available data) | Injection site swelling, injection site reaction (yellow discolouration), injection site necrosisb, Photosensitivityc, Decreased milk productiond |
a Which may be fatal. In case of a serious anaphylactic reaction in cattle the administration of epinephrine, antihistamines and corticosteroids should be considered.
b Swelling will be visible for several days after injection.
c When exposed to intensive sunlight, particularly treated animals with poor skin pigmentation.
d Small drop in lactating animals for up to 3 days following injection.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy and lactation
The placenta is readily passed by oxytetracycline and concentration in the foetal blood may reach those of the maternal circulation, although concentration is usually somewhat lower. The use is not recommended in the last 2-3 weeks of pregnancy.
The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy until 3 weeks before expected partus, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats conducted with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
Tetracyclines are deposited in deciduous and permanent teeth causing discoloration, enamel hypoplasia, and reduced mineralisation. Tetracyclines can retard foetal skeletal development. Oxytetracycline is excreted in the milk; concentrations are generally low.
Interactions
Oxytetracycline should not be administered simultaneously with penicillins or cephalosporins.
Amounts to be administered and administration route
Administration route: intramuscular use (deep). It is strongly recommended to divide the intramuscular dosages over two or more injection sites - maximum 15 ml per injection site in cattle over 150 kg body weight and 7 ml in pigs and calves. Injection sites should be alternated.
Pigs: 20 mg oxytetracycline per kg body weight, if necessary repeat after 72 hours.
Cattle not producing milk for human consumption:
20 mg oxytetracycline per kg body weight, if necessary repeat after 72 hours.
Cattle producing milk for human consumption:
20 mg oxytetracycline per kg body weight as a single injection only.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Overdose
After intramuscular administration of the antibiotic in lethal dosages, central nervous system symptoms as excitation and convulsions, followed by depression, generalized muscular paralysis and respiratory arrest, preceding death were observed (death usually occurs through respiratory failure). Long-term treatment may result in gastrointestinal disturbances and changes of gut flora (supra-infections). High dosages or chronic administration of oxytetracycline may delay bone growth and healing in young animals. Chronic overdose may lead to drug accumulation and nephrotoxicity. There are no known antidotes to oxytetracycline toxicity.
Withdrawal periods
Cattle: meat and offal: 35 days; milk: 8 days.
Pigs: meat and offal: 28 days.