Ovarelin 50 ug/ml, solution for injection for cattle

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Gonadorelin Diacetate Tetrahydrate

Διαθέσιμο από:

Ceva Santé Animale

Φαρμακολογική κατηγορία (ATC):

QH01CA01

INN (Διεθνής Όνομα):

Gonadorelin Diacetate Tetrahydrate

Δοσολογία:

50 microgram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle

Θεραπευτική περιοχή:

gonadorelin

Θεραπευτικές ενδείξεις:

Hormone

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2007-12-07

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
12 April 2019
CRN008S2G
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ovarelin 50 ug/ml, solution for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Composition for 1 ml:_
ACTIVE SUBSTANCE(S):
QUANTITY:
Gonadorelin (as diacetate tetrahydrate)
50.0 µg
EXCIPIENT:
Benzyl alcohol (E1519)
15.0 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: cows, heifers.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction and synchronisation of oestrus and ovulation in combination
with prostaglandin F
2α
(PGF
2α
) or analogue with or
without progesterone as part of Fixed Time Artificial Insemination
(FTAI) protocols.
Treatment of delayed ovulation (repeat breeding).
A repeat breeder cow or heifer is generally defined as an animal that
has been inseminated at least 2 or often 3 times without
becoming pregnant, despite having regular normal œstrus cycles (every
18 -24 days), normal œstrus behaviour and no clinical
abnormalities of the reproductive tract.
4.3 CONTRAINDICATIONS
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 response of dairy cows to synchronisation protocols may be
influenced by the physiological state at the time of treatment,
which includes age of the cow, body condition and interval from
calving.
Responses to treatment are not uniform either across herds or across
cows within herds.
Where a period of progesterone treatment is included in the protocol,
the percentage of cows displaying oestrus within a
given period is usually greater than in untreated cows and the
subsequent luteal phase is of normal duration.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Health Products Regulatory Authority
12 April 2019
CRN008S2G
Page 2 of 5
Special precaution