Nazione: Regno Unito
Lingua: inglese
Fonte: VMD (Veterinary Medicines Directorate)
Oxytocin
Bela-Pharm GmbH & Co. KG
QH01BB02
Oxytocin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Cattle, Dogs, Goats, Horses, Pigs, Sheep
Hormone
Authorized
2014-08-06
Revised: January 2019 AN: 00235/2018 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Revised: January 2019 AN: 00235/2018 Page 2 of 5 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 PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Pregnant or lactating women should a Leggi il documento completo