Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

Clear yellow to reddish-brown aqueous solution packed in amber coloured, glass type II vials with a volume of 100 and 250 ml. Each ml contains 200 mg oxytetracycline (as dihydrate).

Uses

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.

Dosage and administration

The product is indicated for (deep) intramuscular injection. 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 bodyweight and 7 ml in pigs and calves. Injection sites should be alternated.

•Pigs

20 mg oxytetracycline per kg bodyweight, if necessary repeat after 72 hours

•Cattle not producing milk for human consumption

20 mg oxytetracycline per kg bodyweight, if necessary repeat after 72 hours

•Cattle producing milk for human consumption

20 mg oxytetracycline per kg bodyweight as a single injection only

Contra-indications, warnings, etc

Absolute

Hypersensitivity to tetracyclines. The use of oxytetracycline in animals with an impaired liver and/or kidney function should be avoided.

Relative

Because oxytetracycline can retard skeletal development and may cause discolouration and enamel hypoplasia of fetal teeth, the product should be used cautiously in the last half of pregnancy.

Hypersensitivity reactions (cattle), hepatotoxicity and haematologic effects have been reported, but are rare. Treated animals, particularly those with poor skin pigmentation, may develop photodermatitis when exposed to intensive sunlight. Following intramuscular administration a transient swelling and/or yellow staining (and local necrosis) will occur at the site of the injection. Swelling will be visible for several days after injection. Following injection a small drop in milk production may be observed in lactating animals for up to 3 days.

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 product is not recommended in the last 2-3 weeks of pregnancy.

Oxytetracycline is excreted in the milk; concentrations are generally low. In case of a serious anaphylactic reaction in cattle the administration of epinephrine, antihistamines and corticosteroids should be considered. Oxytetracycline should not be administered simultaneously with penicillins or cephalosporins.

Overdose

After intramuscular administration of the antimicrobial in lethal dosages, central nervous system symptoms such as excitation and convulsions, followed by depression, generalised 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.

User safety

Persons with a known hypersensitivity to tetracyclines should not handle this 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. 

For animal treatment only. Keep out of reach and sight of children.

Withdrawal periods

Cattle: meat and offal: 35 days

Milk: 8 days

Pigs: meat and offal: 28 days

Special precautions for use

It is strongly recommended to divide the intramuscular dosages over two or more injection sites. For the 250 ml pack, the use of a multi-dose 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 Cyclosol® LA in the early stages of disease and to evaluate the response to treatment within 72 hours.

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.

Pharmaceutical precautions

The product should not be mixed with other products. Any unused product or waste material should be disposed of in accordance with national requirements. Do not freeze. Keep container in the outer carton.

Legal category

POM-V

Packaging Quantities

Vials of 100 ml and 250 ml solution.

Further information

Nil.

Marketing authorisation number

Vm 16849/4000.