Arabitro® 250mg Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Abiraterone Acetate

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

Abiraterone Acetate

Unit dalam pakej:

120 Tablets

Dikeluarkan oleh:

Glenmark Pharmaceuticals Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ARABITRO
® 250MG TABLETS
Abiraterone Acetate Tablets USP 250mg
1
WHAT IS IN THIS LEAFLET
1.
What ARABITRO is used for
2.
How ARABITRO works
3.
Before you use ARABITRO
4.
How to use ARABITRO
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ARABITRO
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT ARABITRO IS USED FOR
ARABITRO is indicated with
prednisone or prednisolone for the
treatment of prostate cancer that has
spread to other parts of the body.
HOW ARABITRO WORKS
ARABITRO stops your body from
making testosterone. Research has
shown that testosterone helps to fuel
the tumor. Reducing the production
of testosterone is important to
manage your illness.
BEFORE YOU USE ARABITRO
_- When you must not use it _
_Pregnancy and lactation _
ARABITRO must not be taken by
women who are pregnant or breast-
feeding or might be pregnant since
ARABITRO may affect the baby.
If you are pregnant or might be
pregnant, wear gloves if you need to
touch or handle ARABITRO.
_Women, infants and children _
ARABITRO is not for use in women
and children.
_ _
_- Before you start to use it _
ARABITRO can make high blood
pressure or heart failure or low blood
potassium worse. Taking prednisone
or prednisolone with ARABITRO
helps to avoid worsening of these
conditions. If you have these
conditions, or other heart or blood
vessel problems, discuss them with
your doctor.
If you are having sex with a pregnant
woman you need to use a condom. If
you are having sex with a woman
who can become pregnant you need
to use a condom and another
effective birth control method.
ARABITRO may affect your liver.
Rarely, failure of the liver to function
(called acute liver failure) may occur,
which can lead to death. Talk to your
doctor if you develop yellowing of
the skin or eyes, darkening of the
urine, or severe nausea or vomiting,
as these could be signs or symptoms
of liver problems. When you are
taking ARABITRO your doc

Ciri produk

Manufactured by:
At: Plot NO.-B-25, M.I.D.C.,
Shendra, Aurangabad - 431154,
Maharashtra State, INDIA
® Registered Trade Mark
PRODUCT REGISTRATION HOLDER:
Glenmark Pharmaceuticals
(Malaysia) Sdn Bhd (660397-W)
D-31-02, Menara Suezcap 1,
No. 2, Jalan Kerinchi,
59200 Kuala Lumpur, Malaysia
PE00000 MY
SAME SIZE ARTWORK
LEAFLET SIZE : 170 mm x 225 mm
25 mm
34 mm
_For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory_
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE :
PE58020
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
ARABITRO 250 MG TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Arabitro 250 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abiraterone acetate 250 mg
3.
PHARMACEUTICAL FORM
Tablet
4.
PRODUCT DESCRIPTION
White to off white oval shaped uncoated tablets, debossed with “G”
on one side and “135” on
other side that should be swallowed whole with water and cannot be
subdivided.
5.
CLINICAL PARTICULARS
5.1 THERAPEUTIC INDICATION
Arabitro is indicated with prednisone or prednisolone for
l
the treatment of metastatic castration resistant prostate cancer
(mCRPC) in adult men
who are asymptomatic or mildly symptomatic after failure of androgen
deprivation
therapy in whom chemotherapy is not yet clinically indicated.
l the treatment of mCRPC in adult men whose disease has progressed on
or after a
docetaxel-based chemotherapy regimen.
Arabitro is also indicated in combination with prednisone or
prednisolone and androgen
deprivation therapy (ADT) for the treatment of patients with newly
diagnosed high risk
metastatic hormone sensitive prostate cancer (mHSPC) who may have
received up to
3 months of prior ADT.
5.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 1000 mg (four 250 mg tablets) as a single
daily dose that must not
be taken with food (see information on the method of administration).
Taking the tablets with
food increases systemic exposure to abiraterone.
_Dosage of prednisone or presnisolone_
For mCRPC, Arabitro is used with 10 mg prednisone or