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Date: Saturday, June 15, 2024 2:18

Release 2.58
Cyclosol® LA 200 mg/ml Solution for Injection
 
Species: Cattle, Pigs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Oxytetracycline
Product:Cyclosol® LA 200 mg/ml Solution for Injection
Product index: Cyclosol LA 200 mg/ml Solution for Injection
Cattle - milk: 8 days
Cattle - meat: 35 days
Pig - meat: 28 days
Incorporating:
Qualitative and quantitative 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.
Clinical particulars
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
Hypersensitivity to tetracyclines. The use of oxytetracycline in animals with an impaired liver and/or kidney function should be avoided.
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.
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.
Adverse reactions
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 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 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
Oxytetracycline should not be administered simultaneously with penicillins or cephalosporins.
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 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
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.

Pharmacological particulars
Pharmacotherapeutic group: Tetracycline antimicrobial
ATCvet code: QJ01AA06
Pharmacodynamic properties
Oxytetracycline is a bacteriostatic antibiotic. It exerts its action by inhibiting the protein synthesis of the bacterial cell. Inhibition of bacterial protein synthesis results in disturbance of all functions necessary for the life of bacteria, especially cell-division, and the formation of the cell wall are impaired.
Resistance is usually plasmid-mediated. Micro-organisms that have become resistant to one tetracycline frequently exhibit resistance to the others.
Pharmacokinetic properties
Absorption of oxytetracycline following intramuscular injection of CYCLOSOL LA is fast. In pigs the Cmax is measured within 2-3 hours; the Cmax is approximately 4 µg/ml. In cattle absorption is somewhat slower; the Cmax is measured after 3-5 hours; the Cmax is approximately 3-6 µg/ml.
A plasma concentration of 0.5 µg/ml or more is maintained for 72 hours in cattle and pigs. Concentrations of 0.1 μg/ml are maintained for 5 days. Bioavailability of CYCLOSOL LA is approximately 100%.
High concentrations of oxytetracycline are detectable in kidney, liver, and urine, but oxytetracycline is widely distributed in the body, including lungs and muscle. The placenta is readily passed by oxytetracycline and concentration in the foetal blood may reach that of the maternal circulation.
Oxytetracycline apparently is not metabolized in vivo and is eliminated primarily unchanged, via glomerular filtration. It is also excreted into the GI tract via both biliary and nonbiliary routes and may become inactive after chelation with faecal material.
Pharmaceutical particulars
Incompatibilities
In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Shelf life after first opening the container: 14 days.
Special precautions for storage
Do not freeze. Keep container in the outer carton.
Immediate packaging
Amber coloured, glass type II vials containing 50/100/250 ml solution for injection. Not all pack sizes may be marketed.
Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Eurovet Animal Health BV, Handelsweg 25, 5331 AE Bladel, The Netherlands.
Marketing Authorisation Number
VM 16849/4000
Significant changes
Date of the first authorisation or date of renewal
2 July 2008
Date of revision of the text
July 2008
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Cyclosol LA 200 mg/ml Solution for Injection 250 ml:
GTIN:08714225152049