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Gonadorelin injection 100mcg/vial

Presentation

Powder for solution for injection containing gonadorelin 100micrograms/vial.

Drugs List

  • gonadorelin 100microgram powder for solution for injection vial
  • Therapeutic Indications

    Uses

    Evaluating gonadotropic pituitary function following surgery/irradiation
    Hypopituitarism (anterior pituitary function assessment)

    Gonadorelin as a single injection is indicated for evaluating the functional capacity and response of the gonadotropes of the anterior pituitary. The LH/FSH-RH response is used in testing patients with suspected gonadotropin deficiency, whether due to the hypothalamus alone or in combination with anterior pituitary failure.

    Gonadorelin is also indicated for evaluating residual gonadotropic function of the pituitary following removal of a pituitary tumour or surgery and/or irradiation.

    Dosage

    Adults

    100 micrograms injected subcutaneously or intravenously.
    In females for whom the phase of the menstrual cycle can be established, the test should be performed in early follicular phase (days 1 to 7).

    Children

    Children aged 1 to 18 years
    2.5 micrograms/kg (up to 100 micrograms) as a single dose, injected subcutaneously or intravenously.

    Additional Dosage Information

    Refer to product information regarding specific methodology and interpretation of test results to determine the status of the gonadotropin secretory capacity of the anterior pituitary gland.

    Administration

    For subcutaneous and intravenous administration.

    Contraindications

    Children under 1 year
    Breastfeeding
    Pregnancy

    Precautions and Warnings

    Pituitary adenoma
    Porphyria

    Contains lactose
    Exclude pregnancy prior to initiation of treatment
    Female: Ensure adequate contraception during treatment

    Ensure adequate contraception during treatment if administered during follicular phase of normal cycle, due to possible premature ovulation.

    Rare instances of hypersensitivity reactions have been reported. Therefore, if intravenous re-administration is considered in patients treated by intermittent pulsatile therapy, they should be carefully observed.

    The Norwegian Porphyria Centre (NAPOS) and the Porphyria centre Sweden, classifies gonadorelin as possibly porphyrinogenic. It should be used only when no safer alternative is available and precautions should be considered in vulnerable patients.

    Not recommended for use in patients with pituitary adenoma as haemorrhagic infarction (pituitary apoplexy) may occur.

    Pregnancy and Lactation

    Pregnancy

    Gonadorelin is contraindicated during pregnancy.

    At the time of writing, there is limited published information regarding the use of gonadorelin during pregnancy.

    Lactation

    Gonadorelin is contraindicated during breastfeeding.

    At the time of writing, there is limited published information regarding the use of gonadorelin during breastfeeding.

    Side Effects

    Abdominal discomfort
    Antibody formation
    Bronchospasm
    Dizziness
    Erythema
    Flushing
    Headache
    Hypersensitivity reactions
    Induration
    Itching
    Localised and generalised rash
    Menstrual bleeding increased
    Nausea
    Pain
    Redness of face, eyelids & lips
    Sepsis
    Swelling
    Tachycardia
    Thrombophlebitis (injection site)
    Urticaria

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: December 2018

    Reference Sources

    Summary of Product Characteristics: Gonadorelin 100 micrograms powder and solvent for solution for injection. Intrapharm Laboratories Ltd. May 2016.

    NAPOS. The drug database for acute porphyria.
    Available at: https://www.drugs-porphyria.org/
    Pituitary and hypothalamic hormones and analogues. Last revised: September 2018.
    Last accessed: 12 December 2018.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 December 2018.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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