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

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

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

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, corresponding to 1.4 mg/ml when diluted as recommended. Each 16 ml vial contains 400 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 patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel ...

Posology and method of administration

Avastin must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Posology Metastatic carcinoma of the colon or rectum (mCRC) The recommended ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. ...

Special warnings and precautions for use

Gastrointestinal perforations (see section 4.8) Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with Avastin. Intra-abdominal ...

Interaction with other medicinal products and other forms of interaction

Effect of antineoplastic agents on bevacizumab pharmacokinetics No clinically relevant pharmacokinetic interaction of co-administered chemotherapy on Avastin pharmacokinetics has been observed based on ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment. Pregnancy There are no data on the use of Avastin in pregnant ...

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 is no evidence that Avastin treatment results in an increase in adverse reactions that might lead ...

Undesirable effects

The overall safety profile of Avastin is based on data from over 3,500 patients with various malignancies, predominantly treated with Avastin in combination with chemotherapy in clinical trials. The most ...

Overdose

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

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies ATC code: L01XC07 Mechanism of action Bevacizumab binds ...

Pharmacokinetic properties

The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours. In all clinical trials, bevacizumab was administered as an IV infusion. The rate of infusion ...

Preclinical safety data

In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human ...

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 6.6. A concentration dependent degradation profile of bevacizumab was observed when diluted with ...

Shelf life

Vial (unopened): 2 years. Diluted medicinal product: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/ml (0.9%) solution for injection. ...

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 from light. For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab. 16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 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 of the prepared solution. The necessary amount of bevacizumab should be withdrawn and diluted to ...

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