Leading the way to safer medication
 Crosscheck  Recommender

CETROTIDE Powder and solvent for solution for injection (2019)

Active ingredients: Cetrorelix

Product Name and Form

Cetrotide 0.25 mg powder and solvent for solution for injection.

Pharmaceutical form

Powder and solvent for solution for injection.

Appearance of the powder: white lyophilisate.

Appearance of the solvent: clear and colourless solution.

The pH of the reconstituted solution is 4.0-6.0.

Qualitative and Quantitative Composition

Each vial contains 0.25 mg cetrorelix (as acetate).

After reconstitution with the solvent provided, each mL of the solution contains 0.25 mg cetrorelix.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Cetrorelix

Cetrorelix is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. GnRH induces the production and release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the gonadotrophic cells of the anterior pituitary. Due to a positive estradiol (E2) feedback at midcycle, GnRH liberation is enhanced resulting in an LH-surge. This LH-surge induces the ovulation of the dominant follicle, resumption of oocyte meiosis and subsequently luteinization as indicated by rising progesterone levels. Cetrorelix competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner. Cetrorelix binds to the gonadotropin releasing hormone receptor and acts as a potent inhibitor of gonadotropin secretion. It competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner. Cetrotide (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

List of excipients

Powder: Mannitol

Solvent: Water for injections

Pack sizes and Marketing

Powder: 2 ml vials (Type I glass) with a stopper (bromobutyl rubber) and flip-off aluminium cap. 1 vial contains 0.25 mg cetrorelix.

Solvent: Pre-filled syringe (Type I glass) with plunger stopper (siliconised bromobutyl rubber) and tip cap (polypropylene and styrene butadiene rubber). 1 pre-filled syringe contains 1 ml of water for injections.

Pack sizes: 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes.

Additionally, for each vial the pack contains:

  • 1 injection needle (20 gauge)
  • 1 hypodermic injection needle (27 gauge)
  • 2 alcohol swabs

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands

Date of first authorisation: 13 April 1999
Date of latest renewal: 13 April 2009

Marketing authorization number:

EU/1/99/100/001
EU/1/99/100/002