Product Information
Registration Status: ActiveSIN12165P
ORGALUTRAN SOLUTION FOR INJECTION 0.25mg/0.5ml is approved to be sold in Singapore with effective from 2003-07-01. It is marketed by MSD PHARMA (SINGAPORE) PTE LTD, with the registration number of SIN12165P.
This product contains Ganirelix 0.25mg/0.5ml in the form of INJECTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by VETTER PHARMA-FERTIGUNG GMBH & CO KG in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Ganirelix is an injectable competitive gonadotropin-releasing hormone antagonist (GnRH antagonist). It is primarily used in assisted reproduction to control ovulation. The drug works by blocking the action of GnRH upon the pituitary, thus rapidly suppressing the production and action of LH and FSH. Ganirelix is used in fertility treatment to prevent premature ovulation that could result in the harvesting of eggs that are too immature to be used in procedures such as in vitro fertilisation. Ganirelix is marketed by Merck & Co., Inc. as Orgalutran®.
Indication
For the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Mechanism of Action
Ganirelix acts by competitively blocking the GnRH receptors on the pituitary gonadotroph and subsequent transduction pathway. It induces a rapid, reversible suppression of gonadotropin secretion. The suppression of pituitary LH secretion by ganirelix is more pronounced than that of FSH. An initial release of endogenous gonadotropins has not been detected with ganirelix, which is consistent with an antagonist effect. Upon discontinuation of ganirelix, pituitary LH and FSH levels are fully recovered within 48 hours.
Pharmacokinetics
- Absorption
- Ganirelix is rapidly absorbed following subcutaneous injection with maximum serum concentrations reached approximately one hour after dosing.
- Distribution
- The mean (SD) volume of distribution of Ganirelix in healthy females following intravenous administration of a single 250 mg dose is 43.7 (11.4) L.
- Metabolism
- Following single-dose intravenous administration of radiolabeled ganirelix acetate to healthy female volunteers, ganirelix Acetate is the major compound present in the plasma (50–70% of total radioactivity in the plasma) up to 4 hours and urine (17.1–18.4% of administered dose) up to 24 hours. Ganirelix Acetate is not found in the feces. The 1–4 peptide and 1–6 peptide of Ganirelix Acetate are the primary metabolites observed in the feces.
- Elimination
Clearance
Single dose: 2.4L/hour Multiple dose: 3.3L/hour
Active Ingredient/Synonyms
Ganirelix | Ganirelix |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.