Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Oxytocin
aniMedica GmbH
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
1999-10-01
Health Products Regulatory Authority 23 December 2021 CRN00CMGK Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxytocin aniMedica 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Oxytocin 10 I.U. (Voegtlin units) EXCIPIENTS Chlorobutanol hemihydrate 3.00 mg Ethanol (96 %) 40.10 mg 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. Health Products Regulatory Authority 23 December 2021 CRN00CMGK Page 2 of 4 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 THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Pregnant women should avoid direct contact with the product. Care should be taken to avoid accidental self-injection. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None. 4.7 USE DURING PREGNANCY, read_full_document