CYCLOSOL LA 200MG/ML SOLUTION FOR INJECTION
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
07-01-2017
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Senda beiðni.
Virkt innihaldsefni:
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Fáanlegur frá:
Eurovet Animal Health B.V.
ATC númer:
QJ01AA06
INN (Alþjóðlegt nafn):
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Skammtar:
200 Mg/Ml
Lyfjaform:
Solution for Injection
Gerð lyfseðils:
POM
Meðferðarhópur:
Bovine, Porcine
Lækningarsvæði:
Oxytetracycline
Ábendingar:
Antibacterial
Leyfisstaða:
Authorised
Leyfisdagur:
1988-10-01
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclosol LA 200mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Oxytetracycline (as dihydrate)
200 mg
Excipients:
Sodium formaldehyde sulphoxylate dihydrate
5 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellow to reddish-brown solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cyclosol LA is indicated for the treatment of infections caused by oxytetracycline sensitive microorganisms.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use by intravenous route.
Do not use in animals with serious kidney and liver disturbances.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In case of a serious anaphylactic reaction the administration of epinephrine, antihistamines and/or corticosteroids
should be considered.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/12/2016_
_CRN 7025269_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
It is strongly recommended to divide the intramuscular dosages over two or more injection sites (see posology).
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not
possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the
target bacteria.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant t
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