Avastin 25mg/ml concentrate for solution for infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

bevacizumab

Доступна с:

Roche Diagnostics GmbH

код АТС:

L01XC07

ИНН (Международная Имя):

bevacizumab

дозировка:

25mg/ml

Фармацевтическая форма:

concentrate for solution for infusion

Штук в упаковке:

(1) glass vial 4ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2016-06-22

тонкая брошюра

AVASTIN
®
Bevacizumab
ANTINEOPLASTIC AGENT
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent
ATC Code: L01X C07
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Clear to slightly opalescent, colourless to pale brown, sterile liquid
for intravenous (i.v.)
infusion.
Avastin is not formulated for intravitreal use (see section 2.4.1
General [2.4 Warnings and
Precautions]).
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 4.1 List of Excipients.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_METASTATIC COLORECTAL CANCER (MCRC)_
Avastin in combination with fluoropyrimidine-based chemotherapy is
indicated for
treatment of patients with metastatic carcinoma of the colon or
rectum.
_LOCALLY RECURRENT OR METASTATIC BREAST CANCER (MBC)_
Avastin in combination with taxane-based chemotherapy is indicated for
first-line treatment
of patients with locally recurrent or metastatic breast cancer.
_ADVANCED, METASTATIC OR RECURRENT NON-SMALL CELL LUNG CANCER (NSCLC)_
Avastin, 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)_
Avastin in combination with interferon alfa-2a is indicated for
first-line treatment of
patients with advanced and/or metastatic renal cell cancer.
_MALIGNANT GLIOMA (WHO GRADE IV) - GLIOBLASTOMA_
Avastin, as a single agent, or in combination with irinotecan, is
indicated for the treatment
of patients with glioblastoma after relapse or disease progression.
_EPITHELIAL

Характеристики продукта

October 2018
Summary of Product Characteristics
Ro 487-6646
Avastin
October 2018
Production Information FE/English
1
AVASTIN
®
Bevacizumab
ANTINEOPLASTIC AGENT
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent
ATC Code: L01X C07
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Clear to slightly opalescent, colourless to pale brown, sterile liquid
for intravenous (i.v.)
infusion.
Avastin is not formulated for intravitreal use (see section 2.4.1
General [2.4 Warnings
and Precautions]).
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 4.1 List of Excipients.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_METASTATIC COLORECTAL CANCER (MCRC) _
Avastin
in
combination
with
fluoropyrimidine-based
chemotherapy
is
indicated
for
treatment of patients with metastatic carcinoma of the colon or
rectum.
October 2018
Summary of Product Characteristics
Ro 487-6646
Avastin
October 2018
Production Information FE/English
2
_LOCALLY RECURRENT OR METASTATIC BREAST CANCER (MBC) _
Avastin in combination with taxane-based chemotherapy is indicated for
first-line
treatment of patients with locally recurrent or metastatic breast
cancer.
_ADVANCED, METASTATIC OR RECURRENT NON-SMALL CELL LUNG CANCER (NSCLC)
_
Avastin, 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) _
Avastin in combination with interferon alfa-2a is indicated for
first-line treatment of
patients with advanced and/or metastatic ren