Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS
This medicinal product is for diagnostic use only.
GHRH is applied to determine the somatotropic function of the anterior pituitary gland in cases of suspected growth hormone deficiency. The test distinguishes between pituitary and hypothalamic disorders but is not suitable as a screening test for growth hormone deficiencies.
The diluent is supplied for the reconstitution of an injectable preparation.
The recommended dosage for adult patients of standard weight is the content of one ampoule of GHRH Ferring (50 micrograms somatorelin) dissolved in 1ml of the supplied solvent. The solution is administered intravenously as a bolus injection.
In cases of highly overweight adult patients and in children, a dosage of 1 microgram per kg body weight is indicated.
After withdrawal of approximately 2ml of venous blood from the fasted patient, the increase of basal growth hormone levels in plasma or serum after a single intravenous injection of the product is measured. For this procedure, the content of one ampoule is dissolved in 1ml of solvent (0.9% NaCl), or a volume corresponding to 1 microgram per kg body weight if appropriate, is administered intravenously to the fasted patient as a bolus injection (within 30 seconds).
To evaluate the growth hormone increment in plasma or serum, a second blood sample is taken 30 minutes after the injection. Peak growth hormone values may occasionally occur sooner or later. Therefore, additional blood samples may be taken 15, 45, 60 and 90 minutes after GHRH injection for better assessment of growth hormone release.
No case of overdose has been reported.
In case of overdose, the reported undesirable effects may occur (see section 4.8). Since somatorelin is eliminated rapidly from the body no measures in case of overdose are necessary.
The Shelf life is 3 years.
GHRH should not be used after the expiry date printed on the package.
Do not store above 25°C.
GHRH Ferring is supplied in clear glass ampoules of high hydrolytic resistance (hydrolytic Class 1 according to Ph. Eur.).
The diluent is supplied in clear glass ampoules of high hydrolytic resistance (hydrolytic Class 1 according to Ph. Eur.).
Reconstitute GHRH Ferring with the solvent supplied, immediately prior to use.
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