Folltropin 700 IU Powder and Solvent for solution for injection

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Porcine follicle stimulating hormone

Saadav alates:

Vetoquinol Ireland Limited

ATC kood:

QG03GA90

INN (Rahvusvaheline Nimetus):

Porcine follicle stimulating hormone

Annus:

700 international unit/vial

Ravimvorm:

Powder and solvent for solution for injection

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Cattle

Terapeutiline ala:

follicle stimulating hormone-pituitary

Näidustused:

Hormone

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-11-06

Toote omadused

Health Products Regulatory Authority
28 August 2019
CRN00990H
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Folltropin 700 IU Powder and Solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of lyophilized product contains:
ACTIVE SUBSTANCE
Follicle Stimulating Hormone (FSH)
700 IU
One vial of solvent contains:
EXCIPIENTS
Benzyl alcohol (E1519)
360 mg
One ml of reconstituted solution contains:
ACTIVE SUBSTANCE:
Follicle Stimulating Hormone (FSH)
35
IU
EXCIPIENTS
Benzyl alcohol (E1519)
18
mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: Freeze dried off-white powder.
Solvent: Clear, colourless solution.
Reconstituted solution: Clear, slightly pink solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (reproductively mature females).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To induce superovulation in reproductively mature heifers or cows.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in males and reproductively immature female cattle.
Do not use in pregnant cattle.
Health Products Regulatory Authority
28 August 2019
CRN00990H
Page 2 of 4
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product should only be used in clinically healthy cows and mature
heifers, which are cycling normally. There is a wide
range in response to superovulation between animals. There may be a
small proportion of non-responders in any group
treated.
Collection of embryo is normally started on day 7 following observed
oestrus or first breeding. Prior to breeding and the
collection of fertilized embryo from these animals, oestrus will have
to be induced with prostaglandin F2α or a prostaglandin
F2α analogue.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals