Orgalutran 0.25 mg/0.5 ml Solution for injection 1 syringe
Composition:
Each pre-filled syringe contains:
Ganirelix — 0.25 mg in 0.5 ml aqueous solution.
Excipients: less than 1 mmol sodium (23 mg) per injection (essentially sodium-free).
Product Description:
Orgalutran is a synthetic decapeptide with high antagonistic activity against gonadotrophin-releasing hormone (GnRH).
It prevents premature LH surges, thereby supporting controlled ovarian stimulation protocols in ART.
Indications for Use:
Prevention of premature LH surges in women undergoing COH for ART.
Used in combination with recombinant human follicle-stimulating hormone (FSH) or corifollitropin alfa.
Method of Administration and Dosage:
- Subcutaneous injection of 0.25 mg once daily.
- Start on day 5 or 6 of FSH or corifollitropin alfa administration, depending on ovarian response.
- Continue daily until sufficient follicles of adequate size are present.
- Final maturation induced with human chorionic gonadotrophin (hCG).
- The interval between injections and between the last injection and hCG should not exceed 30 hours.
Contraindications:
Hypersensitivity to ganirelix or excipients.
Pregnancy and lactation.
Not indicated for use in men or children.
Precautions:
Should only be prescribed by specialists experienced in infertility treatment.
Monitor ovarian response carefully.
Do not mix with FSH; use separate injection sites.
Adverse Effects:
Common: local injection site reactions (redness, swelling, itching).
Possible: headache, nausea.
Rare: hypersensitivity reactions.
Pregnancy and Lactation:
Contraindicated.
Not to be used during pregnancy or breastfeeding.
Storage Conditions:
Store at 2–8 °C (refrigerated).
Do not freeze.
Protect from light.
Packaging:
Carton box containing 1 pre-filled syringe (0.25 mg/0.5 ml each).