Fertipig HCG 40 IU/ml / PMSG 80 IU/ml lyophilisate and solvent for solution for injection for pigs

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Osta kohe

Laadi alla Toote omadused (SPC)
12-06-2017

Toimeaine:

Gonadotrophin, equine serum (pmsg) ; Gonadotrophin, chorionic (hcg); Gonadotrophin, equine serum (pmsg) ; Gonadotrophin, chorionic (hcg)

Saadav alates:

Ceva Santé Animale

ATC kood:

QG03GA99

INN (Rahvusvaheline Nimetus):

Gonadotrophin, equine serum (pmsg) ; Gonadotrophin, chorionic (hcg); Gonadotrophin, equine serum (pmsg) ; Gonadotrophin, chorionic (hcg)

Annus:

40/ 80 international unit(s)/millilitre

Ravimvorm:

Lyophilisate and solvent for solution for injection

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Pigs

Terapeutiline ala:

gonadotropins, combinations

Näidustused:

Hormone

Volitamisolek:

Authorised

Loa andmise kuupäev:

2010-01-25

Toote omadused

                                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
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