CYCLOSOL LA 200MG/ML SOLUTION FOR INJECTION

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)

제공처:

Eurovet Animal Health B.V.

ATC 코드:

QJ01AA06

INN (International Name):

OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)

복용량:

200 Mg/Ml

약제 형태:

Solution for Injection

처방전 유형:

POM

치료 그룹:

Bovine, Porcine

치료 영역:

Oxytetracycline

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

1988-10-01

제품 특성 요약

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