CYCLOSOL LA 200MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-01-2017
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Active ingredient:
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Available from:
Eurovet Animal Health B.V.
ATC code:
QJ01AA06
INN (International Name):
OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)
Dosage:
200 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Oxytetracycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1988-10-01
Summary of Product characteristics
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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