GHRH Lyophilised powder for injection Ref.[7658] Active ingredients: Somatorelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS

Contraindications

Hypersensitivity to somatorelin (human) acetate or to any of the excipients.

Special warnings and precautions for use

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:

  • untreated hyper – and hypothyroidism
  • obesity, hyperglycaemia, elevated fatty acids
  • high level somatostatin

Interaction with other medicinal products and other forms of interaction

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.

Pregnancy and lactation

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.

Effects on ability to drive and use machines

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.

Undesirable effects

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)

Nervous system disorders

Common: Transient disturbances in sense of smell and taste

Cardiac disorders

Common: Minor fluctuation in blood pressure*, Minor fluctuation in heart rate*

Gastrointestinal disorders

Uncommon: Nausea, vomiting

General disorders and administration site conditions

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.

Incompatibilities

GHRH Ferring should not be administered together with other preparations for parenteral use (e.g. mixed injections or infusion solutions).

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