FOLLTROPIN 700 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
FOLLICE STIMULATING HORMONE, PORCINE
Available from:
Bioniche Animal Health Europe Ltd
ATC code:
QG03GA90
Dosage:
700 International Unit
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Therapeutic group:
Hormone
Therapeutic area:
Bovine
Authorization date:
0000-00-00
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 FOR SOLUTION FOR INJECTION
Active substance:
Follicle Stimulating Hormone
equivalent to 700 I.U. */vial
*(established by WHO Expert Committee on Biological Standardisation in1986)
Excipients:
None.
SOLVENT
Active substance:
None.
Excipients:
Benzyl Alcohol 18 mg/ml as antimicrobial preservative.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The Follicle Stimulating Hormone is an off-white freeze dried powder.
The Folltropin Diluent is a clear, colourless 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/01/2012_
_CRN 7007390_
_page number: 1_
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.
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 be taken when handling the product to avoid self-injec
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