SPC, UK: Avastin 25mg/ml concentrate for solution for infusion
||Roche Products Limited
||Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
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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, ...
Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale brown liquid. ...
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 ...
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 ...
The overall safety profile of Avastin is based on data from over 3,500 patients with various malignancies, ...
The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated ...
Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic ...
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
This medicinal product must not be mixed with other medicinal products except those mentioned in section ...
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.