GONADORELIN Powder for solution for injection Ref.[9559] Active ingredients: Gonadorelin

Although allergic and hypersensitivity reactions have been observed with other polypeptide hormones, to date no such reactions have been encountered following the administration of a single 100 micrograms dose of gonadorelin used for diagnostic purposes. Rare instances of hypersensitivity reactions have been reported. Therefore, patients in whom re-administration is considered, particularly by the intravenous route, should be carefully observed.

Administration during the follicular phase of a normal cycle may result in premature ovulation and appropriate measures are advised to prevent an unwanted pregnancy in these circumstances.

Gonadorelin and its analogues are not recommended for use in patients with pituitary adenoma as haemorrhagic infarction (pituitary apoplexy) may occur.

The gonadorelin test should be conducted in the absence of other drugs which directly affect the pituitary secretion of gonadotropins. These would include a variety of preparations which contain androgens, oestrogens, progestogens or glucocorticoids.

The gonadotropin levels may be transiently elevated by spironolactone, minimally elevated by methyldopa, and suppressed by oral contraceptives and digoxin.

The response to gonadorelin may be blunted by phenothiazines and dopamine antagonists which cause a rise in prolactin.

Gonadorelin should not be administered to pregnant women or nursing mothers.

Gonadorelin has no or negligible influence on the ability to drive and operate machines.

The following adverse drug reactions have been identified or suspected in clinical trials and through post-marketing use. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).

Frequency categories are defined according to the following convention:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Cardiac disorders

Rare: tachycardia

Gastrointestinal disorders

Rare: nausea, abdominal discomfort

General disorders and administration site conditions

Rare: induration at injection site

Immune system disorders

Rare: hypersensitivity reactions

Infections and infestations:

Frequency unknown: sepsis

Investigations

Rare: antibody test – positive for antibody formation

Nervous system disorders

Uncommon: pain

Rare: headache, dizziness

Reproductive system and breast disorders

Frequency unknown: menorrhagia

Respiratory, thoracic and mediastinal disorders

Rare: bronchospasm

Skin and subcutaneous disorders

Uncommon: swelling, pruritis

Rare: urticaria, erythema, erythema of eyelid

Frequency unknown: rash

Vascular disorders

Rare: flushing

Frequency unknown: thrombophlebitis

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Gonadorelin should not be mixed with any other substance.