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SPC, UK: Cetrotide 0.25 mg (2010)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Serono
Διεύθυνση :
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
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Δωρεάν εγγραφή

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 a 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. The first administration of Cetrotide should be performed under the supervision of a physician and under conditions where ...

Contraindications

Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic peptide hormones or to any of the excipients. Pregnancy and lactation. Postmenopausal ...

Special warnings and precautions for use

Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with Cetrotide is not advised in women with severe allergic ...

Interaction with other medicinal products and other forms of interaction

In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way. However, though there ...

Pregnancy and lactation

Cetrotide is not intended to be used during pregnancy and lactation (see section 4.3). Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance ...

Effects on ability to drive and use machines

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

Undesirable effects

The most commonly reported side effects are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. In clinical trials, these ...

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 Cetrorelix is a luteinising hormone releasing hormone (LHRH) antagonist. LHRH binds to membrane receptors on pituitary ...

Pharmacokinetic properties

The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%. The total plasma clearance and the renal clearance are 1.2 ml x min-1 x kg-1 and 0.1 ml x min-1 x kg-1, respectively. ...

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

2 years. The solution should be used immediately after preparation.

Special precautions for storage

Do not store above 25°C. Keep the vial(s) in the outer carton in order to protect from light.

Nature and contents of container

Packs with 1 or 7 Type I glass vials sealed with a rubber stopper. Additionally for each vial the packs contain: 1 pre-filled syringe (Type I glass cartridge closed with rubber stoppers) with 1 ml solvent ...

Special precautions for disposal and other handling

Cetrotide should only be reconstituted with the solvent provided, using a gentle, swirling motion. Vigorous shaking with bubble formation should be avoided. The reconstituted solution is without particles ...

Marketing authorization holder

Merck Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom

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 first renewal: 15 April 2004 Date of latest renewal: March 2009

Date of revision of the text

03/2010