CAPECITABINE-DRLA capecitabine 150 mg tablet blister pack

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

capecitabine, Quantity: 150 mg

থেকে পাওয়া:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Capecitabine

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; hypromellose; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

In blister packs of 60

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Colon Cancer ,Capecitabine 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 is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,Oesophagogastric Cancer,Capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,Breast Cancer,Capecitabine 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 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.

পণ্য সারাংশ:

Visual Identification: Light peach film-coated tablet of biconvex, oblong shape with the marking 150 on one side and RDY on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2013-06-24

তথ্য লিফলেট

1
Capecitabine‐DRLA
CAPECITABINE-DRLA
_FILM-COATED TABLETS_
pronounced
cap-eh-SITE-ah-bean
_contains the active ingredient capecitabine_
_ _
CONSUMER MEDICINE INFORMATION
such as
chemotherapy
•
swelling of the face, lips,
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Capecitabine-DRLA 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
this medicine
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 THIS MEDICINE
IS USED FOR
Capecitabine-DRLA
contains
the
active
ingredient
capecitabine.
Capecitabine-DRLA
belongs
to
a
group of medicines called anti-
neoplastic
agents.
Within
this
group,
Capecitabine-DRLA
belongs to a class of medicines
called
fluoropyrimidine
analogues.
Capecitabine-DRLA
is
used
to
treat
cancer
of
the
bowel
and
rectum
(colorectal),
breast
and
stomach
and
food
pipe
(oesophagus).
It
may
be
prescribed
alone
or
in
combination
with
other
medicines used to treat cancer,
medicines.
The
medicine
contained
in
Capecitabine-DRLA
tablets,
capecitabine,
is
converted
by
the
liver
and
cancer
cells
to
another
medicine
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-DRLA
for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
WHY
CAPECITABINE-DRLA HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
Capecitabine-DRLA
is
not
addictive.
BEFORE YOU TAKE
THIS MEDICINE
_WHEN YOU MUST NOT TAKE _
_IT_
DO
NOT
TAKE
CAPECITABINE-
DRLA
IF:
1.
YOU HAVE HAD AN ALLERGY TO
•
CAPECITABINE OR ANY OF THE
INGREDIENTS LISTED AT THE END
OF
THIS LEAFLET
•
5-FLUOROURACIL (ALSO CALLED 5-
FU),
A
MEDICINE
USED
TO
TREAT
CANCER
•
OTHER
FLUO

পণ্য বৈশিষ্ট্য

AUSTRALIAN PRODUCT INFORMATION – CAPECITABINE-DRLA
(CAPECITABINE) TABLETS
1
NAME OF THE MEDICINE
Capecitabine
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Capecitabine tablets are supplied as biconvex oblong film-coated
tablets for oral administration.
Each light
peach coloured tablet contains 150 mg capecitabine and each peach
coloured
tablet contains 500 mg
capecitabine.
Excipients with known effect: lactose. For the full list of
excipients, see Section 6.1 List of
excipients.
150 mg: Light peach film-coated tablet of biconvex, oblong shape with
the marking “150” on
one side
and “RDY” on other side.
500 mg: Peach, film-coated tablet of biconvex, oblong shape with the
marking “500” on one side
and “RDY”
on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
COLON CANCER
Capecitabine-DRLA tablets are 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-DRLA tablets are indicated for the treatment of patients
with advanced or
metastatic
colorectal cancer.
OESOPHAGOGASTRIC CANCER
Capecitabine-DRLA tablets are indicated for the first-line treatment
of patients with
advanced
oesophagogastric cancer in combination with a platinum-based regimen.
BREAST CANCER
Capecitabine-DRLA tablets are 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-DRLA tablets in combination with docetaxel are indicated
for the treatment of
patients with
locally advanced or metastatic breast cancer after failure of prior
anthracycline
containing chemotherapy.
1
4.2
D
OSE AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Capecitabine tablets should be swallowed with water within 30 minutes
after the end of a meal.
_Monotherapy - Colon, co