FOLLTROPIN 700 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PORCINE FOLLICLE STIMULATING HORMONE

Available from:

Vetoquinol UK Limited

ATC code:

QG03GA90

INN (International Name):

PORCINE FOLLICLE STIMULATING HORMONE

Dosage:

700 International Unit

Pharmaceutical form:

Pdr+Solv for Soln for Inj

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Follicle stimulating hormone-pituitary

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2015-11-06

Summary of Product characteristics

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
Powder vial contains:
ACTIVE SUBSTANCE
Follicle Stimulating Hormone (FSH)
700 IU*
*(established by WHO Expert Committee on Biological Standardisation in 1986)
Solvent vial contains:
EXCIPIENTS
Benzyl alcohol
360 mg
One ml of reconstituted solution contains:
ACTIVE SUBSTANCE:
Follicle Stimulating Hormone (FSH)
35 IU
EXCIPIENTS
Benzyl alcohol
18 mg
For a 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 known cases of hypersensitivity to the active ingredient.
Do not use in males and reproductively immature female cattle.
Do not use in pregnant cattle.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 14/06/2016_
_CRN 7023435_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product should only be used in clinically healthy cows, 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.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should