Fertipig HCG 40 IU/ml / PMSG 80 IU/ml Lyophilisate and Solvent for Solution for Injection for Pigs

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Chorionic Gonadotrophin, Serum Gonadotrophin

Dostupné s:

Ceva Animal Health Ltd

INN (Mezinárodní Name):

Chorionic Gonadotrophin, Serum Gonadotrophin

Léková forma:

Powder and solvent for solution for injection

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Pigs

Terapeutické oblasti:

Hormone sex

Stav Autorizace:

Expired

Datum autorizace:

2010-01-22

Charakteristika produktu

Revised: October 2014
AN: 01873/2013
Page 1 of 6
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 [AT, DE, DK, IE, UK]
Fertipig lyophilisate and solvent for solution for injection for pigs
[BE, BG, CY, EL,
ES, FR, HU, IT, LU, NL, PL, PT, RO, SK]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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)
15 mg
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 the full list of excipients, see section 6.1..
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.
Revised: October 2014
AN: 01873/2013
Page 2 of 6
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.
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
Treatment during the primary luteinised phase or in the middle of the
cycle may
increase the risk of ovarian cysts development.
Do not adjust the dose. Increased doses do not incr