CYCLOSOL LA
Solution for injection.
Target species
Cattle and pigs
Composition
Each millilitre contains:
Active substance:
Oxytetracycline (as dihydrate) 200.0 mg
(Equivalent to 216 mg Oxytetracycline dihydrate)
Excipients:
Sodium formaldehyde sulphoxylate dihydrate (preservative) 5.0 mg
Povidone (complexing agent) 50.0 mg
Pharmaceutical form
Solution for Injection
A clear yellow to reddish-brown aqueous solution.
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
Hypersensitivity to tetracyclines. The use of oxytetracycline in animals with an impaired liver and/or kidney function should be avoided.
Amounts to be administered and administration route
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 body weight 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
Special precautions to be taken by the person administering
the veterinary medicinal product to animals
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.
Special precautions for use in animals
It is strongly recommended to divide the intramuscular dosages over two or more injection sites (see posology). 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 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. Because oxytetracycline can retard skeletal development and may cause discoloration and enamel hypoplasia of fetal teeth, the product should be used cautiously in the last half of pregnancy
Undesirable effects (frequency and seriousness)
Hypersensitivity reactions (cattle), hepatotoxicity and haematologic effects have been reported, but are rare. In case of a serious anaphylactic reaction in cattle the administration of epinephrine, antihistamines and corticosteroids should be considered. 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.
Use during pregnancy or 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 product is not recommended in the last 2-3 weeks of pregnancy. Tetracyclines are deposited in deciduous and permanent teeth causing discoloration, enamel hypoplasia, and reduced mineralisation. Tetracyclines can retard fetal skeletal development. Oxytetracycline is excreted in the milk; concentrations are generally low.
Interactions with other veterinary medicinal products and
other forms of interaction
Oxytetracycline should not be administered simultaneously with penicillins or cephalosporins.
Overdose (symptoms, emergency procedures, antidotes) if necessary
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
