Ovarelin
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
16-10-2012
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Active ingredient:
gonadorelin diacetate 50 µg
Available from:
CEVA Animal Health
ATC code:
QH01CA01
Pharmaceutical form:
Solution for injection
Therapeutic group:
gonadorelin
Therapeutic area:
Cattle Other
Authorization date:
2011-07-07
Summary of Product characteristics
Revised: August 2012
AN : 01289/2011
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
OVARELIN 50 µg/ml, solution for injection for cattle [AT, BE, DE, HU, IE, LU, NL, NO, PL,
PT, UK]
OVUGEN 50 µg/ml, solution for injection for cattle [ES]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Composition for 1 ml: _
ACTIVE SUBSTANCE (S):_ _
Gonadorelin (as diacetate tetrahydrate) ........................... 50.0 µg
EXCIPIENT
Benzyl alcohol ...................................................................... 15.0 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: cows, heifers.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: August 2012
AN : 01289/2011
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Not applicable.
ii.
Special precautions to be taken by the person administering the medicinal
product to animals
Care should be taken when handling the product to avoid self-injection.
Acciden
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