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QuALitAtive And QuAntitAtive
Hypersensitivity reactions (cattle), hepatotoxicity
Meat and offal - 35 days; Milk - 8 days.
Amber coloured, glass type II vials containing
each millilitre contains:
and haematologic effects have been reported,
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
Sodium formaldehyde sulphoxylate
epinephrine, antihistamines and corticosteroids
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
medicinal products should be disposed of in
intensive sunlight. Following intramuscular
Oxytetracycline is a bacteriostatic antibiotic. It
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
several days after injection. Following injection a
of all functions necessary for the life of bacteria,
Eurovet Animal Health BV, Handelsweg 25,
small drop in milk production may be observed
especially cell-division, and the formation of
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
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
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
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
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
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
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
the use of a multidose syringe is recommended.
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,
official and local antimicrobial policies.
if necessary repeat after 72 hours. Cattle not
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
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
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.
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