Ország: Egyesült Királyság
Nyelv: angol
Forrás: VMD (Veterinary Medicines Directorate)
Carbetocin
Veyx-Pharma GmbH
QH01BB03
Carbetocin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Hormone
Authorized
2014-08-05
Revised: July 2019 AN: 01071/2018 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hypophysin LA 35 µg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: _Active substance:_ Carbetocin 35.00 µg _Excipients:_ Chlorocresol 1.00 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 Cattle, pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cows: - Uterine atony during the puerperal period - Placental retention as a consequence of uterine atony - Initiation of milk ejection in stress-induced agalactia or in conditions requiring udder emptying Sows: - Acceleration or restart of parturition after disruption of uterine contractions (uterine atony or inertia) following the expulsion of at least one piglet - Supportive therapy of mastitis-metritis-agalactia (MMA-) syndrome - Initiation of milk ejection - Shortening of total parturition duration as a component of synchronisation of parturition in sows. The product may be applied to sows which have previously been administered an appropriate PGF 2 or PGF 2 analogue (e.g. cloprostenol) not prior to day 114 of pregnancy and have not started farrowing within 24 hours after the PGF 2 or PGF 2 analogue injection (day 1 of pregnancy is the last day of insemination) 4.3 CONTRAINDICATIONS Revised: July 2019 AN: 01071/2018 Page 2 of 6 Do not administer to accelerate parturition if cervix is not opened or if there is a mechanical cause for the delayed parturition such as physical obstruction, positional and postural abnormalities, convulsive labour, threatened rupture of uterus, uterine torsion, relative foetal oversize or deformities of the birth canal. 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 The responsiveness to carbetocin of the myometrium is likel Olvassa el a teljes dokumentumot