LongActon
Nazione: Regno Unito
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
Scheda tecnica
(SPC)
15-05-2012
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Principio attivo:
carbetocin 0.07 mg, carbetocin 0.07 mg/ml
Commercializzato da:
VetCom Phama GmbH
Codice ATC:
QH01BB03
Forma farmaceutica:
Solution for injection
Gruppo terapeutico:
Carbetocin
Area terapeutica:
Cattle Food, Pigs Food
Data dell'autorizzazione:
2009-03-09
Scheda tecnica
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,
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