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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Avastin 25mg/ml concentrate for solution for infusion (2012)

Εκδότης

Εκδότης Roche Products Limited
Διεύθυνση Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
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

Avastin 25 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

Each ml of concentrate contains 25 mg of bevacizumab*. Each 4 ml vial contains 100 mg of bevacizumab, ...

Pharmaceutical form

Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale brown liquid. ...

Therapeutic indications

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult ...

Posology and method of administration

Avastin must be administered under the supervision of a physician experienced in the use of antineoplastic ...

Contraindications

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

Special warnings and precautions for use

Gastrointestinal perforations (see section 4.8) Patients may be at an increased risk for the development ...

Interaction with other medicinal products and other forms of interaction

Effect of antineoplastic agents on bevacizumab pharmacokinetics No clinically relevant pharmacokinetic ...

Fertility, pregnancy and lactation

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

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, there ...

Undesirable effects

The overall safety profile of Avastin is based on data from over 3,500 patients with various malignancies, ...

Overdose

The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated ...

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic ...

Pharmacokinetic properties

The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid ...

Preclinical safety data

In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young ...

List of excipients

Trehalose dihydrate Sodium phosphate Polysorbate 20 Water for injections

Incompatibilities

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

Shelf life

Vial (unopened): 2 years. Diluted medicinal product: Chemical and physical in-use stability has been ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect ...

Nature and contents of container

4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab. ...

Special precautions for disposal and other handling

Avastin should be prepared by a healthcare professional using aseptic technique to ensure the sterility ...

Marketing authorization holder

Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Marketing authorization number(s)

EU/1/04/300/001 – 100 mg/4 ml vial EU/1/04/300/002 – 400 mg/16 ml vial

Date of first authorization / renewal of the authorization

Date of first authorisation: 12 January 2005 Date of latest renewal: 14 January 2010

Date of revision of the text

24 October 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.