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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

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

Προτάσεις

SPC, UK: Cinryze 500 Units powder and solvent for solution for injection (2012)

Εκδότης

Εκδότης ViroPharma Limited
Διεύθυνση Chatsworth House, 29 Broadway, Maidenhead, Berkshire, SL6 1LY, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Cinryze 500 Units powder and solvent for solution for injection.

Qualitative and quantitative composition

Active ingredient: C1inhibitor (human) Each single-use powder vial contains 500 Units of C1 inhibitor ...

Pharmaceutical form

Powder and solvent for solution for injection. White powder. The solvent is a clear, colourless solution. ...

Therapeutic indications

Treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary ...

Posology and method of administration

Cinryze therapy should be initiated under supervision of a physician experienced in the care of patients ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Thrombotic events Thrombotic events have been reported in neonatal and infant subjects undergoing cardiac ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been conducted.

Fertility, pregnancy and lactation

Pregnancy Data on a limited number of exposed pregnancies indicate no adverse effects of C1 inhibitor ...

Effects on ability to drive and use machines

Based upon the clinical data currently available, Cinryze has minor influence on the ability to drive ...

Undesirable effects

Summary of the safety profile The only common adverse reaction observed following Cinryze infusion in ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in hereditary angioedema, C1 inhibitor, plasma derived ATC code: ...

Pharmacokinetic properties

A randomised, parallel group, open-label pharmacokinetic study of Cinryze was performed in subjects with ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of general toxicity ...

List of excipients

Powder: Sodium chloride Sucrose Sodium citrate L-valine L-alanine L-threonine 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. After reconstitution, the product should be used immediately. However, chemical and physical ...

Special precautions for storage

Store below 25°C. Do not freeze. Store in the original package in order to protect from light. For storage ...

Nature and contents of container

500 Units of C1 inhibitor in a colourless glass vial (Type I), sealed with a rubber stopper (Type I) ...

Special precautions for disposal and other handling

Reconstitution and administration of Cinryze Reconstitution, product administration and handling of the ...

Marketing authorization holder

ViroPharma SPRL Rue Montoyer 47 B 1000 Brussels Belgium eu.medinfo@viropharma.com

Marketing authorization number(s)

EU/1/11/688/001

Date of first authorization / renewal of the authorization

15 June 2011

Date of revision of the text

17 August 2012
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.