XELABINE capecitabine 150 mg film-coated tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

capecitabine, Quantity: 150 mg

から入手可能:

Viatris Pty Ltd

医薬品形態:

Tablet, film coated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

120 Tablets in blister pack, 30 Tablets in blister pack, 60 Tablets in blister pack

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Colon Cancer:,Capecitabine is indicated for the adjuvant treatment of patients with Duke?s stage C and highrisk 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.

製品概要:

Visual Identification: Light peach coloured, oblong shaped, biconvex, film-coated tablets, debossed with 150 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Registered

情報リーフレット

XELABINE
CONSUMER MEDICINE INFORMATION
Version: 3.0
-2016- Page: 1 of 5
XELABINE
(CAPECITABINE FILM-COATED TABLETS 150 MG AND 500 MG)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Xelabine 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
Xelabine
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 XELABINE IS USED
FOR
Xelabine contains the active
ingredient capecitabine.
Xelabine belongs to a group of
medicines called anti-neoplastic
agents. Within this group,
Xelabine belongs to a class of
medicines called
fluoropyrimidine analogues.
Xelabine 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,
such as chemotherapy
medicines.
The medicine contained in
Xelabine 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 Xelabine for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY XELABINE HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
_Xelabine is not addictive._
BEFORE YOU TAKE
XELABINE
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE XELABINE 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 FLUOROPYRIMIDINE
MEDICINES
_ _
Some of the symptoms of an
allergic reaction may include:
_ _
•
shortness of breath
•
wheezing or difficulty in
br

製品の特徴

Xelabine (Capecitabine Tablets 150 mg and 500 mg) Version 2.0
Page 1 of 34
PRODUCT INFORMATION
XELABINE
(CAPECITABINE FILM-COATED TABLETS 150 MG AND 500 MG)
NAME OF THE MEDICINE
Capecitabine
(CAS Registry Number: 154361-50-9)
The
chemical
name
for
capecitabine
is
5’-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-
cytidine with the molecular formula C
15
H
22
FN
3
O
6
and a molecular weight of 359.35.
DESCRIPTION
Capecitabine is an oral, antineoplastic agent belonging to the
fluoropyrimidine carbamate
class. It was rationally designed as an orally administered precursor
of 5’-deoxy-5-
fluorouridine
(5’-DFUR),
which
is
selectively
activated
to
the
cytotoxic
moiety,
fluorouracil, in tumours. Capecitabine is a white to off-white
crystalline powder with an
aqueous solubility of 26 mg/mL at 20°C.
Xelabine
is
supplied
as
oblong
shaped,
biconvex
film-coated
tablets
for
oral
administration. Each light peach coloured tablet contains 150 mg
capecitabine and each
peach coloured tablet contains 500 mg capecitabine. The inactive
ingredients in Xelabine
are lactose anhydrous, cellulose microcrystalline, croscarmellose
sodium, hypromellose,
and magnesium stearate. The peach or light peach film coating contains
hypromellose,
purified talc, titanium dioxide and iron oxide yellow and iron oxide
red.
PHARMACOLOGY
Capecitabine itself is non-cytotoxic; however, it is selectively
activated to the cytotoxic
moiety, fluorouracil (5-FU), by thymidine phosphorylase in tumours.
PHARMACODYNAMICS
BIOACTIVATION
Capecitabine is a fluoropyrimidine carbamate derivative that was
designed as an orally
administered, tumour-activated and tumour-selective cytotoxic agent.
Capecitabine is
noncytotoxic
_in vitro_
.
Capecitabine is absorbed unchanged from the gastrointestinal tract,
metabolised primarily
in the liver by the 60 kDa carboxylesterase to
5’-deoxy-5-fluorocytidine (5’-DFCR),
Xelabine (Capecitabine Tablets 150 mg and 500 mg) Version 2.0
Page 2 of 34
which is then converted to 5’-DFUR by cytidine deaminase,
principally located in the
liver