1. Name Of The Medicinal Product
GHRH Ferring
2. Qualitative And Quantitative Composition
Active Ingredient
Somatorelin as acetate, 50 micrograms per ampoule.
3. Pharmaceutical Form
Lyophilised powder for injection.
Sterile solution for reconstitution of an injectable preparation.
4. Clinical Particulars
4.1 Therapeutic Indications
The product is applied to determine the somatotropic function of the anterior pituitary gland in cases of suspected growth hormone deficiency. The test distinguishes between hypophysic 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.
4.2 Posology And Method Of Administration
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.
GHRH Test: 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.
4.3 Contraindications
Hypersensitivity to growth hormone releasing hormone.
4.4 Special Warnings And Precautions For Use
Because of possible inhibitory influence of human growth hormone on the somatotropic function of the pituitary gland, the GHRH Ferring test should not be carried out earlier than one week after discontinuation of treatment with human growth hormone.
The test results may be affected in conditions such as:
− untreated hyperthyroidism
− obesity, hyperglycaemia, elevated plasma fatty acids
− high levels of somatostatin
Although no hypersensitivity reactions have yet been reported, the possibility of this kind of adverse event cannot be completely ruled out because of the peptide nature of this product and the intravenous route of administration. It is recommended that emergency facilities should be available to treat such a reaction if it occurs.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The concomitant administration of substances which influence the release of growth hormone, such as growth hormone itself, somatostatin or its analogues, atropine, levodopa, dopamine, clonidine, arginine, ornithine, glycine, glucagon, insulin, oral glucose, anti thyroid drugs and propranolol should be avoided. High levels of glucocorticoids as well as somatostatin may inhibit the growth hormone response.
4.6 Pregnancy And Lactation
GHRH Ferring is not indicated during pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
Occasionally, a mild sensation of warmth may appear in the head, neck and upper part of the body, and there may be disturbances of smell and taste. These side effects are short lasting and will fade rapidly. In combination with “hot flush”, a slight increase or decrease in blood pressure may occur occasionally in conjunction with the corresponding alterations in heart rate. The described side effects are insignificant when the suggested dose is applied and they do not need any special treatment.
4.9 Overdose
In cases of higher dosage, the known side effects may occur. The undesirable effects fade rapidly and do not need any special treatment.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Somatorelin is normally synthesised in the hypothalamus and stimulates the secretion of growth hormone from the pituitary gland.
GHRH Ferring is the synthetic form of somatorelin and is identical in structure and function to the somatorelin released by the hypothalamus.
Somatorelin physiologically increases plasma growth hormone levels.
5.2 Pharmacokinetic Properties
After intravenous application of different doses of somatorelin in man, the concentrations of somatorelin in plasma increase within 5 minutes to the maximum value, followed by a rapid decrease. The basal values are reached again after 30-40 minutes.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
None
Each diluent ampoule contains
Sodium chloride Ph.Eur | 9mg |
Water for injection Ph.Eur to | 1.0ml |
6.2 Incompatibilities
GHRH Ferring should not be administered together with other preparations for parenteral use (e.g. mixed injections or infusion solutions).
6.3 Shelf Life
The Shelf life is 3 years.
GHRH should not be used after the expiry date printed on the package.
6.4 Special Precautions For Storage
Do not store above 25oC.
6.5 Nature And Contents Of Container
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.).
6.6 Special Precautions For Disposal And Other Handling
Reconstitute GHRH Ferring with the solvent supplied, immediately prior to use.
7. Marketing Authorisation Holder
Ferring Pharmaceuticals Limited
The Courtyard
Waterside Drive
Langley
Berkshire SL3 6EZ.
8. Marketing Authorisation Number(S)
GHRH Ferring PL 03194/0050
Diluent for GHRH Ferring PL 03194/0051
9. Date Of First Authorisation/Renewal Of The Authorisation
24th October 2008
10. Date Of Revision Of The Text
March 2010
11. LEGAL CATEGORY
POM
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