Capecitabine Winthrop

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Capecitabine 150mg

Հասանելի է:

sanofi-aventis new zealand limited

INN (Միջազգային անվանումը):

Capecitabine 150 mg

Դոզան:

150 mg

Դեղագործական ձեւ:

Film coated tablet

Կազմը:

Active: Capecitabine 150mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose   Iron oxide red Iron oxide yellow Macrogol 400 Magnesium stearate Microcrystalline cellulose Purified talc Purified water   Titanium dioxide

Ռեկվիզորի տեսակը:

Prescription

Պատրաստված է:

Divi's Laboratories Limited

Թերապեւտիկ ցուցումներ:

Capecitabine Winthrop is indicated for the treatment of patients with locally advanced or / metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated. Capecitabine Winthrop in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Blister pack, Al/PVC/PE/PVDC - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/PVC/PE/PVDC - 200 tablets - 36 months from date of manufacture stored at or below 25°C

Հաստատման ամսաթիվը:

2012-08-16

Տեղեկատվական թերթիկ

Consumer Medicine Information
December-2020
Capecitabine Winthrop - 150mg and 500mg
capecitabine-win-ccdsv1-cmiv6-01dec20
Page 1
CAPECITABINE WINTHROP
®
Capecitabine 150mg and 500mg film-coated tablets
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Capecitabine Winthrop tablets.
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
Capecitabine Winthrop tablets
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 CAPECITABINE
WINTHROP IS USED
FOR
Capecitabine Winthrop
contains the active ingredient
capecitabine.
Capecitabine Winthrop belongs
to a group of medicines called
anti-neoplastic agents. Within
this group, Capecitabine
Winthrop belongs to a class of
medicines called
fluoropyrimidine analogues.
Capecitabine Winthrop is used
to treat cancer of the bowel and
rectum (colorectal),
oesophagus, stomach and
breast. It may be prescribed
alone or in combination with
other medicines used to treat
cancer.
The medicine contained in
Capecitabine Winthrop tablets,
capecitabine, is converted by
liver and cancer cells to another
substance called 5-fluorouracil
(also called 5-FU).
It is 5-FU that acts to kill or
stop the growth of cancer cells.
Your doctor may have
prescribed Capecitabine
Winthrop for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
CAPECITABINE WINTHROP HAS
BEEN PRESCRIBED FOR YOU
.
This medicine is available only
with a doctor’s prescription.
Capecitabine Winthrop is not
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE CAPECITABINE
WINTHROP IF:
1) YOU HAVE HAD AN ALLERGY TO
• CAPECITABINE OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
• 5-FLUOROURACIL (ALSO KNOWN
AS 5-FU), A M

Ապրանքի հատկությունները

DATA SHEET
17-Sep-18
Capecitabine Winthrop - 150mg and 500mg
capecitabine-winthrop-dsv6-an-17sep18
1
DATA SHEET
1
CAPECITABINE WINTHROP 150 MG, 500 MG FILM COATED
TABLET
Capecitabine 150 mg and 500 mg film-coated tablets
Cytostatic agent.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Capecitabine Winthrop 150 mg film-coated tablet contains 150 mg
capecitabine.
Each Capecitabine Winthrop 500 mg film-coated tablet contains 500 mg
capecitabine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capecitabine Winthrop 150 mg film-coated tablets are light peach in
colour, oval in shape
embossed with “150” on one side.
Capecitabine Winthrop 500 mg film-coated tablets are peach in colour,
oblong capsule-shaped
embossed with “500” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BREAST CANCER
Capecitabine Winthrop is indicated for the treatment of patients with
locally advanced or
metastatic breast cancer after failure of taxanes and an anthracycline
containing chemotherapy
regimen unless therapy with these and other standard agents are
clinically contraindicated.
Capecitabine Winthrop in combination with docetaxel is indicated for
the treatment of patients
with locally advanced or metastatic breast cancer after failure of
prior anthracycline containing
chemotherapy
DATA SHEET
17-Sep-18
Capecitabine Winthrop - 150mg and 500mg
capecitabine-winthrop-dsv6-an-17sep18
2
COLON CANCER
Capecitabine Winthrop is indicated for the adjuvant treatment of
patients with Dukes' Stage C and
high-risk Stage B colon cancer, either as monotherapy or in
combination with oxaliplatin.
COLORECTAL CANCER
Capecitabine Winthrop is indicated for first-line treatment of
patients with metastatic colorectal
cancer.
OESOPHAGOGASTRIC CANCER
Capecitabine Winthrop is indicated for the first-line treatment of
patients with advanced
oesophagogastric cancer in combination with a platinum-based regimen.
4.2
DOSE AND METHOD OF ADMINISTRATION
Capecitabine Winthrop should only be prescribed by a qualified
physician ex