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Drug Details

GHRH Ferring

• Drug Class Description
  Not Specified
• Generic Name
  Somatorelin
• Presentation
  Lyophilised powder for injection. Sterile solution for reconstitution of an injectable preparation.
• Description
  Active Ingredient Somatorelin as acetate, 50 micrograms per ampoule.
• 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.
• Adult Dosage
  

  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.

• Child Dosage
  Refer to Summary of Product Characteristics.
• Contra Indications
  

  Hypersensitivity to growth hormone releasing hormone

• Special Precautions
  

  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.

• Interactions
  

  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.

• Adverse Drug Reactions
  

  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.