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CETROTIDE Powder and solvent for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cetrotide 0.25 mg powder and solvent for solution for injection.

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. ...

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. ...

Therapeutic indications

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. In clinical trials Cetrotide was used with human ...

Posology and method of administration

Cetrotide should only be prescribed by a specialist experienced in this field. Posology The first administration of Cetrotide should be performed under the supervision of a physician and under conditions ...

Contraindications

Cetrorelix is not to be used in the presence of any of the conditions listed below: Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic ...

Special warnings and precautions for use

Allergic conditions Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported (see section 4.8). Special care should be taken in women with ...

Interaction with other medicinal products and other forms of interaction

No formal drug-drug interaction studies have been performed with cetrorelix. In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome ...

Fertility, pregnancy and lactation

Pregnancy and breast-feeding Cetrotide is not intended to be used during pregnancy and lactation (see section 4.3). Fertility Studies in animals have indicated that cetrorelix exerts a dose related influence ...

Effects on ability to drive and use machines

Cetrotide has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. ...

Overdose

Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects. In acute toxicity studies in rodents non-specific toxic symptoms were observed ...

Pharmacodynamic properties

Pharmacotherapeutic group: anti-gonadotropin-releasing hormones ATC code: H01CC02 Mechanism of action Cetrorelix is a luteinising hormone releasing hormone (LHRH) antagonist. LHRH binds to membrane receptors ...

Pharmacokinetic properties

Absorption The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%. Distribution The volume of distribution (V<sub>d</sub>) is 1.1 L x kg<sup>-1</sup>. Elimination The ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. No target ...

List of excipients

Powder: Mannitol Solvent: Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life Unopened vial: 2 years. After reconstitution: use immediately.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Store in the original package in order to protect from light. The unopened medicinal product ...

Nature and contents of container

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 ...

Special precautions for disposal and other handling

This medicinal product must be allowed to reach room temperature prior to injection. It should be removed from the refrigerator approximately 30 minutes before use. Cetrotide should only be reconstituted ...

Marketing authorization holder

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

Marketing authorization number(s)

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

Date of first authorization / renewal of the authorization

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

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