CAPECITABINE SANDOZ FILM COATED TABLET 150MG

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

CAPECITABINE

Disponível em:

NOVARTIS (SINGAPORE) PTE LTD

Código ATC:

L01BC06

Dosagem:

150mg

Forma farmacêutica:

TABLET, FILM COATED

Composição:

CAPECITABINE 150mg

Via de administração:

ORAL

Tipo de prescrição:

Prescription Only

Fabricado por:

Hetero Labs Ltd, Unit- VI

Status de autorização:

ACTIVE

Data de autorização:

2014-11-26

Características técnicas

1.
NAME OF THE MEDICINAL PRODUCT
Capecitabine Sandoz film-coated tablet 150mg
Capecitabine Sandoz film-coated tablet 500mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPECITABINE SANDOZ FILM-COATED TABLET 150MG:
Each film-coated tablet contains 150 mg capecitabine.
Excipient(s) with known effect:
Each film-coated tablet contains 13.8 mg lactose monohydrate.
CAPECITABINE SANDOZ FILM-COATED TABLET 500MG:
Each film-coated tablet contains 500 mg capecitabine.
Excipient(s) with known effect:
Each film-coated tablet contains 46.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Capecitabine Sandoz film-coated tablet 150mg
Light pink film-coated tablet of modified oval shape (5.5 x 11.0 mm)
with the marking “150” on one
side.
Capecitabine Sandoz film-coated tablet 500mg
Pink film-coated tablet of modified oval shape (8.4 x 16.0 mm) with
the marking “500” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Colorectal cancer: _
Capecitabine Sandoz Film Coated Tablet is indicated for the adjuvant
treatment of patients following
surgery of stage III (Dukes’ stage C) colon cancer.
Capecitabine Sandoz Film Coated Tablet is indicated for the treatment
of metastatic colorectal
cancer.
_Gastric cancer: _
Capecitabine Sandoz Film Coated Tablet is indicated for first-line
treatment of advanced gastric
cancer in combination with a platinum-based regimen.
_Breast cancer: _
Capecitabine Sandoz Film Coated Tablet in combination with docetaxel
is indicated for the
treatment of patients with locally advanced or metastatic breast
cancer after failure of cytotoxic
chemotherapy. Previous therapy should have included an anthracycline.
Capecitabine Sandoz Film
Coated Tablet is also indicated as monotherapy for the treatment of
patients with locally advanced or
metastatic breast cancer after failure of taxanes and an
anthracycline-containing chemotherapy
regimen or for whom further anthracycline therapy is not indicated.
4.2
POSOLOGY AND METHOD OF ADM