Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
OXYTOCIN PH. EUR. (EQUIVALENT TO 10 IU OXYTOCIN)
Bela-Pharm GmbH & Co. KG
QH01BB02
OXYTOCIN PH. EUR. (EQUIVALENT TO 10 IU OXYTOCIN)
10 IU/ML
Solution for Injection
POM
Bovine, Canine, Caprine, Equine - Food, Feline, Ovine, Porcine
Oxytocin
Hormone
Authorised
2014-02-21
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 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, dogs (bitches) and cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In the mare, cow, sow, ewe, goat, bitch and cat 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 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. 1 ml contains: ACTIVE SUBSTANCE: Oxytocin 16.6 µg (equivalent to 10 IU Oxytocin) EXCIPIENTS: Chlorobutanol hemihydrate 3.0 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _0_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _6_ _4_ _ Preberite celoten dokument