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QuALitAtive And QuAntitAtive
Adverse reactions
Withdrawal periods
immediate packaging
ComPosition
Hypersensitivity reactions (cattle), hepatotoxicity Cattle: Meat and offal - 35 days; Milk - 8 days.
Amber coloured, glass type II vials containing each millilitre contains: Active substance:
and haematologic effects have been reported, Pigs: Meat and offal - 28 days.
50/100/250 ml solution for injection. Not but are rare. In case of a serious anaphylactic (equivalent to 216 mg oxytetracycline dihydrate) reaction in cattle the administration of PhArmACoLogiCAL PArtiCuLArs
excipients: Sodium formaldehyde sulphoxylate
epinephrine, antihistamines and corticosteroids disposal
Any unused veterinary medicinal product or particularly those with poor skin pigmentation, waste materials derived from such veterinary For a full list of excipients, see Excipients.
may develop photodermatitis when exposed to Pharmacodynamic properties
medicinal products should be disposed of in intensive sunlight. Following intramuscular Oxytetracycline is a bacteriostatic antibiotic. It PhArmACeutiCAL form
administration a transient swelling and/or yellow exerts its action by inhibiting the protein Solution for injection. A clear yellow to reddish- staining (and local necrosis) will occur at the synthesis of the bacterial cell. Inhibition of marketing authorisation holder (if different
site of the injection. Swelling will be visible for bacterial protein synthesis results in disturbance from distributor)
several days after injection. Following injection a of all functions necessary for the life of bacteria, Eurovet Animal Health BV, Handelsweg 25, CLiniCAL PArtiCuLArs
small drop in milk production may be observed especially cell-division, and the formation of target species
in lactating animals for up to 3 days.
the cell wall are impaired. Resistance is usually plasmid-mediated. Micro-organisms that have marketing authorisation number
use during pregnancy and lactation
become resistant to one tetracycline frequently indications for use
Cattle: For the treatment of respiratory
oxytetracycline and concentration in the date of the first authorisation or date of
infections caused by oxytetracycline susceptible foetal blood may reach those of the maternal Pharmacokinetic properties
intramuscular injection of Cyclosol LA is fast. In not recommended in the last 2-3 weeks of pigs, the Cmax is measured within 2 to 3 date of revision of the text
Pigs: For the treatment of respiratory infections
pregnancy. Tetracyclines are deposited in hours; the Cmax is approximately 4 μg/ml. In cattle, absorption is somewhat slower; organisms such as Pasteurella multocida.
discolouration, enamel hypoplasia and reduced the Cmax is measured after 3 to 5 hours; Any other information
mineralisation. Tetracyclines can retard the Cmax is approximately 3 to 6 μg/ml. A For animal treatment only. To be supplied only Contraindications
foetal skeletal development. Oxytetracycline plasma concentration of 0.5 μg/ml or more Hypersensitivity to tetracyclines. The use of is excreted in the milk; concentrations are is maintained for 72 hours in cattle and pigs. Manufacturing authorisation holder responsible oxytetracycline in animals with an impaired Concentrations of 0.1 μg/ml are maintained liver and/or kidney function should be avoided.
for 5 days. Bioavailability of Cyclosol LA is interactions
special precautions for use in animals
Oxytetracycline should not be administered of oxytetracycline are detectable in kidney, It is strongly recommended to divide the liver, and urine, but oxytetracycline is widely Legal category
distributed in the body, including lungs and injection sites (see Amounts to be administered muscle. The placenta is readily passed by and administration route). For the 250 ml pack, Amounts to be administered and
oxytetracycline and concentration in the signifiCAnt ChAnges
the use of a multidose syringe is recommended. administration route
foetal blood may reach that of the maternal gtin (global trade item no)
To refill the syringe, the use of a draw off needle circulation. Oxytetracycline apparently is not Cyclosol LA 200 mg/ml Solution for Injection is recommended to avoid excessive broaching metabolised in vivo and is eliminated primarily of the stopper. It is recommended to use unchanged, via glomerular filtration. It is also Cyclosol LA 200 mg/ml Solution for Injection 50 Cyclosol LA in the early stages of disease and dosages over two or more injection sites - excreted into the GI tract via both biliary and to evaluate the response to treatment within 72 maximum 15 ml per injection site in cattle non-biliary routes and may become inactive hours. Resistance against oxytetracycline may over 150 kg body weight and 7 ml in pigs and after chelation with faecal material.
vary. Use of the product should be based on calves. Injection sites should be alternated.
(A business unit of Dechra Pharmaceuticals PLC) susceptibility testing and taking into account Pigs: 20 mg oxytetracycline per kg body weight, PhArmACeutiCAL PArtiCuLArs
official and local antimicrobial policies.
if necessary repeat after 72 hours. Cattle not excipients
Inappropriate use of the product may increase producing milk for human consumption: 20 mg Magnesium oxide light, ethanolamine (for pH oxytetracycline per kg body weight, if necessary repeat after 72 hours. Cattle producing milk for agent), sodium formaldehyde sulphoxylate effectiveness of treatment with tetracyclines due human consumption: 20 mg oxytetracycline per dihydrate, n-Methyl-2-pyrrolidone, water for to the potential for cross-resistance. Because kg body weight as a single injection only.
oxytetracycline can retard skeletal development overdose
incompatibilities
hypoplasia of foetal teeth, the product should After intramuscular administration of the In the absence of compatibility studies this be used cautiously in the last half of pregnancy.
antibiotic in lethal dosages, central nervous mixed with other veterinary medicinal products special precautions to be taken by the
person administering the veterinary
generalised muscular paralysis and respiratory medicinal product to animals
arrest, preceding death were observed (death shelf life
Persons with a known hypersensitivity to usually occurs through respiratory failure). Long Shelf life of the veterinary medicinal product as tetracyclines should not handle this product. term treatment may result in gastrointestinal packaged for sale: 30 months. Shelf life after The direct or indirect contact of the user via first opening the container: 14 days.
skin or mucosa should be avoided because of (supra-infections). High dosages or chronic Do not use after the expiry date stated on the the risk of sensitisation. Wash hands after use. administration of oxytetracycline may delay In case of contact with eyes or skin, wash bone growth and healing in young animals.
immediately with water as irritation may occur.
special precautions for storage
accumulation and nephrotoxicity. There are no Do not freeze. Keep container in the outer known antidotes to oxytetracycline toxicity.
carton. Keep out of the reach and sightof children.

Source: http://www.specific-diets.ch/files//dechra/Downloads/Pharma/SPCs%20Global/SPC%20Sheet%20-%20Cyclosol%20(final).pdf