Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
LEGAL STATUS

1. NAME OF THE MEDICINAL PRODUCT

 Avastin 25 mg/ml concentrate for solution for infusion.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each ml contains 25 mg of bevacizumab.

Each vial contains 100 mg of bevacizumab in 4 ml and 400 mg in 16 ml respectively, corresponding to 1.4 to 16.5 mg/ml when diluted as recommended.

Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster ovary cells.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

 Concentrate for solution for infusion.

Clear to slightly opalescent, colourless to pale brown liquid.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.

Avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer. For further information as to HER2 status, please refer to section 5.1.

Avastin in combination with capecitabine is indicated for first-line treatment of patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.

Avastin, in addition to platinum-based chemotherapy, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.

Avastin in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and/or metastatic renal cell cancer.
4.2 Posology and method of administration

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

It is recommended that treatment be continued until progression of the underlying disease.

Dose reduction for adverse events is not recommended. If indicated, the