AVASTIN bevacizumab 100mg/4mL injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Bevacizumab, Quantity: 100 mg

Saadav alates:

Roche Products Pty Ltd

Ravimvorm:

Injection, concentrated

Koostis:

Excipient Ingredients: monobasic sodium phosphate monohydrate; water for injections; polysorbate 20; trehalose dihydrate; dibasic sodium phosphate heptahydrate

Manustamisviis:

Intravenous

Ühikuid pakis:

1 vial

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

? Metastatic ColorectaI Cancer AVASTIN (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. ? Locally recurrent or metastatic Breast Cancer AVASTIN (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated.(see Clinical Trials). ? Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC) AVASTIN (bevacizumab), in combination with carboplatin and paclitaxel, 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 RenaI Cell Cancer AVASTIN (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer ? Grade IV Glioma AVASTIN (bevacizumab) as a single agent, is indicated for t

Toote kokkuvõte:

Visual Identification: Clear to slightly opalescent, colourless to pale brown solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2005-02-24

Infovoldik

AVASTIN
®
PRONOUNCED (A-VAS-TIN)
_contains the active ingredient bevacizumab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Avastin infusion.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Avastin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT AVASTIN IS USED
FOR
Avastin is used to treat;
•
brain tumours resistant to
previous treatments
•
metastatic (spreading) cancer of
the large bowel (i.e. in the colon
or rectum), breast or cervix in
combination with chemotherapy
agents
•
lung cancer and cancer of the
ovaries and fallopian tubes
(which can extend to the lining of
surrounding organs such as
stomach, liver) in combination
with chemotherapy agents
•
kidney cancer (renal cell cancer)
in combination with interferon
therapy (Roferon-A
®
).
Avastin contains the active ingredient
bevacizumab.
Avastin belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. Avastin belongs to
a class known as anti-angiogenic
agents.
Anti-angiogenic agents inhibit
angiogenesis (the process of forming
new blood vessels in your body).
Avastin selectively binds to vascular
endothelial growth factor (VEGF), a
protein found on the cells that line
blood vessels. Tumours produce high
levels of VEGF, which stimulates
blood vessels to grow, thereby
providing the tumour with nutrients
and oxygen.
When Avastin blocks VEGF it
disrupts the blood supply to the
tumour, stopping or slowing down its
growth.
There are many different types of
medicines used to treat brain tumours
and metastatic cancer of the large
bowel, breast, lung, kidney and
cervix.
Your doctor may have prescribed
Av

Toote omadused

Avastin
®
210126
1
AUSTRALIAN
PRODUCT
INFORMATION
AVASTIN
® (BEVACIZUMAB)
1
NAME OF THE MEDICINE
bevacizumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avastin is available in 100 mg and 400 mg single dose vials containing
4 mL and 16 mL,
respectively, of bevacizumab (25 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Avastin is a clear to slightly opalescent, colourless to pale brown,
sterile solution for intravenous
(IV) infusion. Avastin is not formulated for intravitreal use (see
Section 4.4; Severe Eye Infections
Following Compounding for Unapproved Intravitreal Use).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
METASTATIC COLORECTAL CANCER
Avastin (bevacizumab) in combination with fluoropyrimidine-based
chemotherapy is indicated for
the treatment of patients with metastatic colorectal cancer.
LOCALLY RECURRENT OR METASTATIC BREAST CANCER
Avastin (bevacizumab) in combination with paclitaxel is indicated for
the first-line treatment of
metastatic breast cancer in patients in whom an anthracycline-based
therapy is contraindicated. (see
Section 5.1 Clinical Trials).
ADVANCED, METASTATIC OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG
CANCER (NSCLC)
Avastin (bevacizumab), in combination with carboplatin and paclitaxel,
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
Avastin (bevacizumab) in combination with interferon alfa-2a is
indicated for treatment of patients
with advanced and/or metastatic renal cell cancer.
GRADE IV GLIOMA
Avastin (bevacizumab) as a single agent, is indicated for the
treatment of patients with Grade IV
glioma after relapse or disease progression after standard therapy,
including chemotherapy.
Avastin
®
210126
2
EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER
Avastin (bevacizumab) in combination with carboplatin and paclitaxel,
is indicat