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CINRYZE Powder and solvent for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Cinryze 500 IU powder and solvent for solution for injection.

Qualitative and quantitative composition

Each single-use powder vial contains 500 International Units (IU) of C1 inhibitor (human) produced from the plasma of human donors. After reconstitution, one vial contains 500 IU of C1 inhibitor (human) ...

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, adolescents and children (2 years old and above) with hereditary angioedema (HAE). Routine prevention of angioedema attacks in adults, ...

Posology and method of administration

Cinryze therapy should be initiated under supervision of a physician experienced in the care of patients with hereditary angioedema (HAE). Posology Adult Treatment of angioedema attacks: 1000 IU of Cinryze ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Thrombotic events Thrombotic events have been reported in neonatal and infant subjects undergoing cardiac bypass procedures while receiving off-label high doses of another C1 inhibitor product (up to 500 ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Fertility, pregnancy and lactation

Pregnancy Data on a limited number of exposed pregnancies indicate no adverse effects of C1 inhibitor on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The very common adverse reactions observed following Cinryze infusion in clinical studies were headache and nausea. Tabulated list of adverse reactions Adverse reaction frequencies ...

Overdose

No case of overdose has been reported.

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in hereditary angioedema, C1 inhibitor, plasma derived ATC code: B06AC01 Mechanism of action C1 inhibitor is a member of the serine protease inhibitor, or serpin, ...

Pharmacokinetic properties

A randomised, parallel group, open-label pharmacokinetic study of Cinryze was performed in subjects with non-symptomatic HAE. The subjects received either a single intravenous dose of 1000 Units(*) or ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of general toxicity and toxicity to reproduction. No genotoxicity studies were performed as the active substance is unlikely ...

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 6.6. Only use a silicone-free syringe (provided in the pack) for administration of the product. ...

Shelf life

Shelf life: 2 years. After reconstitution, the product should be used immediately. However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature (15°C-25°C).

Special precautions for storage

Store below 25°C. Do not freeze. Store in the original package in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nature and contents of container

500 IU of C1 inhibitor in a colourless glass vial (Type I), sealed with a rubber stopper (Type I) and an aluminium seal with a plastic flip-off cap. 5 ml of water for injections in a colourless glass vial ...

Special precautions for disposal and other handling

Each kit contains material for either one 1000 IU dose or two 500 IU doses. Reconstitution and administration of Cinryze Reconstitution, product administration and handling of the administration set and ...

Marketing authorization holder

Shire Services BVBA, Rue Montoyer 47, B-1000, Brussels, Belgium

Marketing authorization number(s)

EU/1/11/688/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 June 2011 Date of latest renewal: 26 May 2016

Date of revision of the text

06/2019

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