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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cetrotide 0.25 mg (2010)

Εκδότης

Εκδότης Merck Serono
Διεύθυνση Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
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Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

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 ...

Pharmaceutical form

Powder and solvent for solution for injection. Appearance of the powder: white lyophilisate Appearance ...

Therapeutic indications

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by ...

Posology and method of administration

Cetrotide should only be prescribed by a specialist experienced in this field. The first administration ...

Contraindications

Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone ...

Special warnings and precautions for use

Special care should be taken in women with signs and symptoms of active allergic conditions or known ...

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 ...

Pregnancy and lactation

Cetrotide is not intended to be used during pregnancy and lactation (see section 4.3). Studies in animals ...

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 ...

Overdose

Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with ...

Pharmacodynamic properties

Pharmacotherapeutic group: anti-gonadotropin-releasing hormones ATC code: H01CC02 Cetrorelix is a luteinising ...

Pharmacokinetic properties

The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%. The total ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

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 ...

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 ...

Special precautions for disposal and other handling

Cetrotide should only be reconstituted with the solvent provided, using a gentle, swirling motion. Vigorous ...

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: ...

Date of revision of the text

03/2010
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.