MVASI bevacizumab 100 mg/4 mL injection concentrated vial

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Bevacizumab, Quantity: 100 mg

Pieejams no:

Amgen Australia Pty Ltd

Zāļu forma:

Injection, concentrated

Kompozīcija:

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

Ievadīšanas:

Intravenous Infusion

Vienības iepakojumā:

1 vial

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Metastatic Colorectal Cancer:,MVASI (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.,Locally recurrent or metastatic Breast Cancer:,MVASI (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):,MVASI (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:,MVASI (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.,Grade IV Glioma:,MVASI (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.,Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer:,MVASI (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first line treatment of patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.,Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer:,MVASI (bevacizumab), in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.,MVASI (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.,Cervical Cancer:,MVASI (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. MVASI (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

Produktu pārskats:

Visual Identification: Clear to slightly opalescent, colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

2020-06-30

Lietošanas instrukcija

MVASI
®
_PRONOUNCED (EM VAH' SEE)_
_contains the active ingredient bevacizumab pronounced
bev·a·ciz·u·mab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MVASI 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 MVASI
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 MVASI IS USED
FOR
MVASI contains the active
ingredient bevacizumab.
MVASI is a biosimilar medicine to
AVASTIN
®
. The evidence for
comparability supports the use of
MVASI for the treatment of:
•
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
®
).
MVASI belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. MVASI belongs to
a class known as anti-angiogenic
agents.
Anti-angiogenic agents inhibit
angiogenesis (the process of forming
new blood vessels in your body).
MVASI 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 MVASI 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

Produkta apraksts

MVASI
® (BEVACIZUMAB) PRODUCT INFORMATION PAGE 1 OF 56
MVASI PRODUCT INFORMATION
AUSTRALIAN PRODUCT INFORMATION – MVASI
®
(BEVACIZUMAB)
1.
NAME OF THE MEDICINE
MVASI is a biosimilar medicine to Avastin
®
(bevacizumab). The evidence for
comparability supports the use of MVASI for the listed indications.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MVASI 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.
MVASI is a clear to slightly opalescent, colourless to pale yellow,
sterile solution for
intravenous (IV) infusion. MVASI is not formulated for intravitreal
use (see section 4.4
Special warnings and precautions for use, Severe eye infections
following compounding
for unapproved intravitreal use).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metastatic Colorectal Cancer
MVASI (bevacizumab) in combination with fluoropyrimidine-based
chemotherapy is
indicated for the treatment of patients with metastatic colorectal
cancer.
Locally recurrent or metastatic Breast Cancer
MVASI (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 Pharmacodynamic
properties, Clinical trials).
Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung
Cancer (NSCLC)
MVASI (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.
MVASI
® (BEVACIZUMAB) PRODUCT INFORMATION PAGE 2 OF 56
MVASI PRODUCT INFORMATION
Advanced and/or metastatic Renal Cell Cancer
MVASI (bevacizumab) in combination with interferon alfa-2a is
indicated for treatment of
patients with advanced and/or metastatic renal cell cancer.
Grade IV Glioma
MVASI (bevacizum