Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Oxytocin synthetic
Laboratorios Hipra S.A.
QH01BB02
Oxytocin synthetic
10 international unit(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Cattle, Dogs, Pigs, Sheep
oxytocin
Hormone
Authorised
2000-09-01
Health Products Regulatory Authority 20 June 2019 CRN0094NJ Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRACIN10 IU/ml Synthetic Oxytocin, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Synthetic Oxytocin 10 IU/ml EXCIPIENTS: Chlorobutanol hemihydrate 5 mg/ml 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 Sows, Ewes, Cows, Bitches, and Queens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In general, for all target species: Stimulation of uterine contractions to facilitate parturition in the presence of a fully dilated cervix. To promote involution of the post-parturient uterus and thus aid the passage of retained placenta. To help control post-partum haemorrhage. Promotion of milk let-down in cases of agalactia and as a co-adjuvant in antibiotic treatment of mastitis. 4.3 CONTRAINDICATIONS Do not use in females with obstructive dystochia, pelvic-foetal disproportion or with any other mechanical obstruction. Do not use in animals with cardiovascular problems. To prevent the risk of foetal death and possible uterine rupture, do not use to induce parturition if cervical dilatation is not confirmed. Do not use in sows with normal parturition. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Adrenaline at physiological levels markedly reduces the effect of oxytocin on the uterus and mammary gland. For this reason the animal should not be stressed when complete oxytocin effect is desired to cause either milk let-down or uterine contractions. 4.5 SPECIAL PRECAUTIONS FOR USE Health Products Regulatory Authority 20 June 2019 CRN0094NJ Page 2 of 4 SPECIAL PRECAUTIONS FOR USE IN ANIMALS The intravenous injection must be given by slow intravenous infusion. A low initial dose is recommended and should only be increased if no effect is observed. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PROD Lugege kogu dokumenti