Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS
Hypersensitivity to somatorelin (human) acetate or to any of the excipients.
Because of the possible inhibitory influence of human growth hormone (hGH) on the somatotropic function of the pituitary gland the GHRH-test should not be carried out sooner than 1 week after discontinuation of treatment with human growth hormone.
The test results may be affected by the following conditions:
Concomitant use of substances influencing the release of growth hormone, such as growth hormone itself, as well as atropine, levodopa, dopamine, clonidine, arginine, ornithine, glycine, glucagon, insulin, oral glucose, thyreostatics and propranolol should be avoided. High levels of glucocorticoids as well as somatostatin or its analogues may inhibit the growth hormone release.
In general, there is no indication for administration of somatorelin during pregnancy and lactation.
There are no adequate data from the use of GHRH Ferring in pregnant women.
Animal studies are insufficient with respect to effects on pregnancy. The potential risk for humans is unknown. Somatorelin should not be used during pregnancy unless clearly necessary.
There is insufficient information on the excretion of somatorelin in human or animal breast milk. The potential for adverse effects in the nursing infant from exposure to the drug is unknown. Somatorelin should not be used during lactation unless clearly necessary.
No studies on the effects on the ability to drive and use machines have been performed.
Due to the short duration of action of somatorelin the influence on the ability to drive and use machines is expected to be negligible.
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100)
Rare (≥1/10000 to <1/1000)
Very rare (<1/10000)
Common: Transient disturbances in sense of smell and taste
Common: Minor fluctuation in blood pressure*, Minor fluctuation in heart rate*
Uncommon: Nausea, vomiting
Common: Transient flushing
Uncommon: Injection site pain, Chest tightness
* In combination with flushing
As with all intravenous injections of peptides, anaphylactic reactions cannot be excluded.
GHRH Ferring should not be administered together with other preparations for parenteral use (e.g. mixed injections or infusion solutions).
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