Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
OXYTOCIN PH. EUR. 0.018 MG EQUIVALENT TO
aniMedica GmbH
QH01BB02
OXYTOCIN PH. EUR. 0.018 MG EQUIVALENT TO
10 IU/ML
Solution for Injection
POM
Bovine, Canine, Caprine, Equine - Food, Feline, Ovine, Porcine
Oxytocin
Hormone
Authorised
1999-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxytocin aniMedica 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Equine, Bovine, Porcine, Ovine, Caprine, Canine and Feline. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Oxytocin aniMedica is indicated for obstetric use (stimulation of paturition, promotion of uterine involution and control of post partum haemorrhage) and the treatment of agalactia in the mare, cow, sow, ewe, goat, bitch and cat. 4.3 CONTRAINDICATIONS Use in any form of obstructive dystocia. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Adrenaline at physiological levels markedly reduces the effect of Oxytocin on the uterus or mammary gland. For this reason the animal should not be frightened when complete Oxytocin effect is desired to cause either milk "let-down" or uterine contractions. Each ml contains: ACTIVE SUBSTANCE Oxytocin 10 I.U. (Voegtlin units) EXCIPIENTS Chlorobutanol hemihydrate 3.00 mg Ethanol (96 %) 40.10 mg HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 21/11/2016_ _CRN 7024717_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS When Oxytocin aniMedica is used as an aid in parturition cervical dilation must be confirmed prior to administration to prevent risk of foetal death and possible uterine rupture. Excessive doses of Oxytocin aniMedica may delay parturition by producing uncoordinated uterine contractions which interfere with the progress of the foetus especially in multiple pregnancies. SPECIAL PRECAUTIONS TO BE TAKEN BY Прочитать полный документ