Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
LECIRELIN ACETATE
FATRO S.p.A.
QH01CA92
LECIRELIN ACETATE
25 Microgram/ML
Solution for Injection
POM
Bovine, Rabbits
Lecirelin
Hormone
Authorised
2004-03-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DALMARELIN, 25 micrograms/ml, solution for injection for cattle and rabbits. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and rabbits. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE Treatment of follicular ovarian cysts. Induction of ovulation at the time of insemination in cases of short, silent heat or prolonged heat. RABBITS Induction of ovulation. Conception rate enhancement. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. ACTIVE SUBSTANCE: Lecirelin acetate equivalent to lecirelin 25 micrograms EXCIPIENTS: Benzyl alcohol (E1519) 20 mg For a full list of exciients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/05/2015_ _CRN 7019402_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Women of childbearing age should administer Dalmarelin with caution since lecirelin has been shown to be foetotoxic in rats. In case of accidental self-injection, seek medical advice.GnRH-analogues may be absorbed through intact skin. In case of dermal contact wash the exposed area immediately with soap and water. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None observed. 4.7 USE DURING PREGNANCY, LACTATION OR LAY The use of Dalmarelin is not recommended during pregnancy. Dalmarelin can be used during lactation. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None k Citiți documentul complet