GEREF 50 50 Microgram Pdr+Solv for Soln for Inj
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-05-2024
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Active ingredient:
SERMORELIN ACETATE
Available from:
Serono Limited
INN (International Name):
SERMORELIN ACETATE
Dosage:
50 Microgram
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Authorization status:
Withdrawn
Authorization date:
2007-07-06
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
GEREF® 50
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of powder contains sermorelin acetate equivalent to 50 micrograms of sermorelin.
Each ampoule of Geref is accompanied by a solvent ampoule containing 0.9 % Sodium Chloride Injection BP.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection
A white, sterile, pyrogen-free, crystalline powder for solution for injection in a clear, Type I glass ampoule
accompanied by a clear, Type 1 glass ampoule containing a clear colourless, sterile solution for reconstitution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the evaluation of the functional capacity and response of the somatotrophs of the anterior pituitary.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended procedure: A single intravenous injection of 1.0 microgram/kg body weight in the morning following
an overnight fast.
Geref should be reconstituted immediately before use with a minimum of 0.5ml of the accompanying sterile solvent.
Venous blood samples should be drawn 15 minutes before and immediately prior to Geref administration. Venous
blood samples are then drawn at 15, 30, 45 and 60 minutes following Geref injection. Samples at 90 and 120 minutes
are optional, since in the majority of patients they do not give additional information.
4.3 CONTRAINDICATIONS
Use in patients known to be hypersensitive to sermorelin acetate or any of the excipients of Geref.
Use during pregnancy or lactation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The test should only be carried out and interpreted under specialist supervision.
Patients already on growth hormone therapy should have therapy discontinued one to two weeks pre-test.
The test should be carried out with parti
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