Avastin Concentrate for Solution for Infusion 400mg16ml

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Bevacizumab

Tilgjengelig fra:

ROCHE SINGAPORE PTE. LTD.

ATC-kode:

L01FG01

Dosering :

400mg

Legemiddelform:

INFUSION, SOLUTION CONCENTRATE

Sammensetning:

Bevacizumab 400mg

Administreringsrute:

INTRAVENOUS

Resept typen:

Prescription Only

Produsert av:

F. Hoffmann-La Roche Ltd

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2012-02-06

Informasjon til brukeren

 
1

AVASTIN
™

Bevacizumab 
ANTI-NEOPLASTIC AGENT 

1.  P
HARMACEUTICAL 
F
ORM

Concentrate for solution for infusion. 
Clear to slightly opalescent, colourless to pale brown, sterile
liquid for intravenous (i.v.) infusion. 
Avastin is not formulated for intravitreal use. _(see section
3.4 Special Warnings and Special Precautions for _
_Use)_ 

2.  Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

_Active ingredient:_ Bevacizumab (humanised anti-VEGF monoclonal
antibody). 
Avastin is supplied in 100 mg and 400
mg preservative-free, single-use vials containing 4 ml or 16
ml of 
Avastin (25 mg/ml)  
Each Avastin 100 mg vial contains 100 mg of bevacizumab.  
Each Avastin 400 mg vial contains 400 mg of bevacizumab. 
For excipients, see section 5.1 List of Excipients. 

3.  C
LINICAL 
P
ARTICULARS

3.1  THERAPEUTIC INDICATIONS 
Avastin 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 the
treatment of patients who have not received 
chemotherapy for metastatic HER2-negative breast cancer.  
Avastin in combination with capecitabine is indicated for
first-line treatment of patients with HER2-
negative 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.  
The effectiveness of Avastin in metastatic breast cancer
(mBC) is based on an improvement in progression-
free survival. Currently, no data are
available that demonstrate an improvement in disea

Preparatomtale

Please visit www.roche.com.sg/pharma/avastin for a
printable version of this leaflet.
INF-AVA-2023 05-0
Avastin
™
Bevacizumab
Anti-neoplastic agent
ATC Code: L01FG01
1.
P
HARMACEUTICAL
F
ORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to pale brown, sterile liquid
for intravenous (i.v.)
infusion.
Avastin is not formulated for intravitreal use. (see section 3.4
Special Warnings and Special
Precautions for Use)
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Active ingredient: Bevacizumab (humanised anti-VEGF monoclonal
antibody).
Avastin is supplied in 100 mg and 400 mg preservative-free, single-use
vials containing 4 ml
or 16 ml of Avastin (25 mg/ml)
Each Avastin 100 mg vial contains 100 mg of bevacizumab.
Each Avastin 400 mg vial contains 400 mg of bevacizumab.
For excipients, see section 5.1 List of Excipients.
3.
C
LINICAL
P
ARTICULARS
3.1 Therapeutic Indications
Metastatic carcinoma of the colon or rectum(mCRC)
Avastin in combination with fluoropyrimidine-based chemotherapy is
indicated for treatment
of patients with metastatic carcinoma of the colon or rectum.
Metastatic Breast Cancer (mBC)
Avastin in combination with paclitaxel is indicated for the treatment
of patients who have not
received chemotherapy for metastatic HER2-negative breast cancer.
Avastin in combination with capecitabine is indicated for first-line
treatment of patients with
HER2-negative 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.
The effectiveness of Avastin in metastatic breast cancer (mBC) is
based on an improvement
in progression-free survival. Currently, no data are available that
demonstrate an improvement
in disease-related symptoms or increased survival with Avastin in
breast cancer.
Non-Small Cell L