Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Oxytocin
Bela-Pharm GmbH & Co. KG
QH01BB02
Oxytocin
10 international unit(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Cattle, Dogs, Goats, Horses, Pigs, Sheep
oxytocin
Hormone
Authorised
2014-02-21
Health Products Regulatory Authority 04 February 2019 CRN000YLY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Oxytocin 16.6 µg (equivalent to 10 IU Oxytocin) EXCIPIENTS: Chlorobutanol hemihydrate 3.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses (mares), cattle (cows), pigs (sows), sheep (ewes), goats (nanny), dogs (bitches) and cats (queen) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In the mare, cow, sow, ewe, nanny, bitch and queen the product is indicated for: Obstetric use (stimulation of uterine contraction to facilitate parturition in the presence of a fully dilated cervix, promotion of involution of the post partum uterus, aid in the control of post partum haemorrhage). Promotion of milk let-down in cases of agalactia. 4.3 CONTRAINDICATIONS Do not use in cases of obstructive dystocia and/or in cases of non-dilatation of the uterine cervix. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Health Products Regulatory Authority 04 February 2019 CRN000YLY Page 2 of 5 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. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS When the veterinary medicinal product 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. SPECIAL PRE Citiți documentul complet