Hypophysin LA 35 microgram/ml Solution for Injection for Cattle and Pigs

Ország: Egyesült Királyság

Nyelv: angol

Forrás: VMD (Veterinary Medicines Directorate)

Vedd Meg Most

Letöltés Termékjellemzők (SPC)
23-01-2023

Aktív összetevők:

Carbetocin

Beszerezhető a:

Veyx-Pharma GmbH

ATC-kód:

QH01BB03

INN (nemzetközi neve):

Carbetocin

Gyógyszerészeti forma:

Solution for injection

Recept típusa:

POM-V - Prescription Only Medicine – Veterinarian

Terápiás csoport:

Cattle, Pigs

Terápiás terület:

Hormone

Engedélyezési státusz:

Authorized

Engedély dátuma:

2014-08-05

Termékjellemzők

                                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
                                
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