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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

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

Προτάσεις

SPC, UK: Soliris (2012)

Εκδότης

Εκδότης Alexion Pharma UK Ltd
Διεύθυνση Unit 14, Horizon Business Village , Horizon Business Village , 1 Brooklands Road, Weybridge, Surrey, KT13 0TJ, UK
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Περιεχόμενα

Name of the medicinal product

Soliris 300 mg concentrate for solution for infusion.

Qualitative and quantitative composition

Eculizumab is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA ...

Pharmaceutical form

Concentrate for solution for infusion. Clear, colorless, pH 7.0 solution.

Therapeutic indications

Soliris is indicated for the treatment of patients with: Paroxysmal nocturnal haemoglobinuria (PNH). ...

Posology and method of administration

Soliris must be administered by a healthcare professional and under the supervision of a physician experienced ...

Contraindications

Hypersensitivity to eculizumab, murine proteins or to any of the excipients listed in section 6.1. Soliris ...

Special warnings and precautions for use

Soliris is not expected to affect the aplastic component of anaemia in patients with PNH. Meningococcal ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Fertility, pregnancy and lactation

Woman of childbearing potential Woman of childbearing potential have to use effective contraception during ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The most common or serious adverse reactions were headache (occurred mostly ...

Overdose

No case of overdose has been reported.

Pharmacodynamic properties

Pharmacotherapeutic group: Selective immunosuppressants ATC code: L04AA25 Soliris is a recombinant humanised ...

Pharmacokinetic properties

Pharmacokinetics and Drug Metabolism Biotransformation Human antibodies undergo endocytotic digestion ...

Preclinical safety data

The specificity of eculizumab for C5 in human serum was evaluated in two in vitro studies. The tissue ...

List of excipients

Sodium phosphate, monobasic Sodium phosphate, dibasic Sodium chloride Polysorbate 80 Water for injections ...

Incompatibilities

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

Shelf life

30 months. After dilution, the medicinal product should be used immediately. However, chemical and physical ...

Special precautions for storage

Store in a refrigerator (2°C 8°C). Do not freeze. Store in the original package in order to protect ...

Nature and contents of container

30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) ...

Special precautions for disposal and other handling

Prior to administration, the Soliris solution should be visually inspected for particulate matter and ...

Marketing authorization holder

Alexion Europe SAS 25 Boulevard de lAmiral Bruix 75016 Paris FRANCE

Marketing authorization number(s)

EU/1/07/393/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 June 2007 Date of latest renewal: 20 June 2012

Date of revision of the text

18/06/2012
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.