FERTIPIG HCG 40 IU/ML / PMSG 80 IU/ML LYOPHILISATE AND SOLVENT FOR SOLUTION FOR INJECTION FOR PIGS.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-11-2014
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Active ingredient:
GONADOTROPHIN EQUINE SERUM (PMSG), GONADOTROPHIN CHORIONIC (HCG)
Available from:
Ceva Santé Animale
ATC code:
QG03GA99
INN (International Name):
GONADOTROPHIN EQUINE SERUM (PMSG), GONADOTROPHIN CHORIONIC (HCG)
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate and solvent for solution for injection
Prescription type:
POM
Therapeutic group:
Porcine
Therapeutic area:
Gonadotropins, combinations
Therapeutic indications:
Hormone
Authorization status:
Authorised
Authorization date:
2010-01-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fertipig HCG 40 IU/ml / PMSG 80 IU/ml lyophilisate and solvent for solution for injection for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.
Lyophilisate: white to off-white freeze-dried powder.
Solvent: clear colourless solution.
Reconstituted solution: clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To sows after weaning:
Induction and synchronization of œstrus within 7 days following the treatment.
Reduction of the weaning to oestrus interval in sows with late oestrus.
Treatment of the seasonal anoestrus.
Lyophilisate vial contains:
ACTIVE SUBSTANCES
Equine serum gonadotrophin (PMSG)
2 000 IU
Gonadotrophin chorionic (HCG)
1 000 IU
Solvent vial contains:
EXCIPIENTS
Benzyl alcohol (E1519)
375
mg
One ml of reconstituted solution contains:
ACTIVE SUBSTANCES
Equine serum gonadotrophin (PMSG)
80
IU
Gonadotrophin chorionic (HCG)
40
IU
EXCIPIENTS
Benzyl alcohol (E1519)
Reconstituted solution for 1 dose of 5 ml contains:
ACTIVE SUBSTANCES
Equine serum gonadotrophin (PMSG)
400
IU
Gonadotrophin chorionic (HCG)
200
IU
EXCIPIENTS
Benzyl alcohol (E1519)
75
mg
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 07/11/2014_
_CRN 7017641_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not administer to pregnant animals.
Do not administer to animals with known hypersensitivity to the active substances or to any of the excipients.
Do not administer to sows with follicular cysts.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment during the primary
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