Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
carbetocin 0.07 mg, carbetocin 0.07 mg/ml
VetCom Phama GmbH
QH01BB03
Solution for injection
Carbetocin
Cattle Food, Pigs Food
2009-03-09
SPC VetCom -Pharma GmbH LONGACTON ® (D; AT; BE; LU) / REPROCINE ® (FR; ESP; UK; IRE; NL) (Procedure-No.: DE/V/0106/001/R/002) SPC-Final-Stand 01/2010 page 1 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT LongActon / Reprocine 0.07 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active Substance: Carbetocin 0.07 mg Excipients: Chlorobutanol hemihydrate 2.00 mg For a 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, pig 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cow: - 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 Sow: - Uterine atony during the puerperal period - Supportive therapy of mastitis-metritis-agalactia (MMA-) syndrome - Initiation of milk ejection - Shortening of total parturition duration in sows: either after delivery of the first piglet or as a component of synchronisation of parturition in sows, which have not farrowed 24 hours after administration of an appropriate PGF 2 (e.g. cloprostenol) not before day 113 of pregnancy. 4.3 CONTRAINDICATIONS 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 abnormali- ties, Read the complete document