PGF Veyx forte 0.250 mg/ml solution for injection for cattle and pigs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Cloprostenol sodium

Dostopno od:

Veyx-Pharma GmbH

Koda artikla:

QG02AD90

INN (mednarodno ime):

Cloprostenol sodium

Odmerek:

0.250 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cattle, Pigs

Terapevtsko območje:

cloprostenol

Terapevtske indikacije:

Hormone

Status dovoljenje:

Authorised

Datum dovoljenje:

2012-10-19

Lastnosti izdelka

Health Products Regulatory Authority
22 August 2017
CRN000TXD
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PGF Veyx forte 0.250 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCE:
Cloprostenol 0.250 mg (corresponding to 0.263 mg cloprostenol sodium)
EXCIPIENTS:
Chlorocresol 1.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (heifers, cows) and pigs (sows)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle (heifers, cows):

To schedule the time of oestrous and ovulation and for cycle
synchronization in animals with an ovulatory cycle when applied during
the
diestrus (induction of oestrus in non-detected oestrus,
synchronisation of
oestrus)

Treatment of anoestrus and uterine disorders caused by a
progesterone-induced oestrous cycle blockade (induction of oestrous in
anoestrus, endometritis, pyometra, corpus luteal cysts, follicular
luteal cysts,
shortening of the sexual rest period)

Induction of abortion up to day 150 of pregnancy

Expulsion of mummified foetuses

Induction of parturition
Health Products Regulatory Authority
22 August 2017
CRN000TXD
Page 2 of 7
Pigs (sows):

Induction or synchronisation of farrowing from day 114 of pregnancy
onwards (day 1 of pregnancy is the last day of insemination).
4.3 CONTRAINDICATIONS

Do not use for intravenous administration

Do not use in pregnant animals where the induction of abortion or
parturition is not intended

Do not use in case of spastic diseases of the respiratory tract and
gastrointestinal tract

Do not use in cases of hypersensitivity to the active substance or to
any of
excipients
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
To reduce the risk of anaerobic infections care should be taken to
avoid inject