MVASI Concentrate for Solution for Infusion 25 mgml

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

Bevacizumab

Disponível em:

Amgen Biopharmaceuticals Malaysia Sdn Bhd

DCI (Denominação Comum Internacional):

Bevacizumab

Unidades em pacote:

100 mg; 400 mg

Fabricado por:

Amgen Manufacturing Limited

Folheto informativo - Bula

Not Applicable

Características técnicas

1
FULL PRESCRIBING INFORMATION
MVASI
®
BEVACIZUMAB
1.
DESCRIPTION
MVASI is a biosimilar medicine to the reference product AVASTIN
™
(bevacizumab). The
evidence for comparability supports the use of MVASI for the listed
indications.
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Anti-neoplastic agent
ATC Code: L01XC07
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Clear to slightly opalescent, colourless to slightly yellow, sterile
liquid for intravenous (i.v.)
infusion. MVASI is not formulated for intravitreal use (_see 2.4.1
Warnings and Precautions, _
_General_)
1.4
STERILE/RADIOACTIVE STATEMENT
Sterile
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Bevacizumab (humanised anti-VEGF monoclonal
antibody).
MVASI is supplied in 100 mg preservative-free, single-use vials to
deliver 4 mL of MVASI
(25 mg/mL).
MVASI is supplied in 400 mg preservative-free, single-use vials to
deliver 16 mL of MVASI
(25 mg/mL).
For excipients, see section 4.1 “List of Excipients”.
2
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
_METASTATIC COLORECTAL CANCER (MCRC) _
MVASI (bevacizumab) in combination with fluoropyrimidine-based
chemotherapy is
indicated for treatment of patients with metastatic carcinoma of the
colon or rectum.
_METASTATIC BREAST CANCER (MBC) _
MVASI in combination with paclitaxel is indicated for first-line
treatment of patients with
metastatic breast cancer.
_ADVANCED, METASTATIC OR RECURRENT NON-SMALL CELL LUNG CANCER (NSCLC)
_
MVASI, in addition to platinum-based chemotherapy, is indicated for
first-line treatment of
patients with unresectable advanced, metastatic or recurrent
non-squamous non-small cell
lung cancer.
_ADVANCED AND/OR METASTATIC RENAL CELL CANCER (MRCC) _
MVASI in combination with interferon alfa-2a is indicated for
first-line treatment of patients
with advanced and/or metastatic renal cell cancer.
_GLIOBLASTOMA _
MVASI is indicated for the treatment of glioblastoma with progressive
disease following
prior therapy as single agent.