Abiratred Abiraterone Acetate Tablets 250mg

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

Abiraterone Acetate

זמין מ:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (שם בינלאומי):

Abiraterone Acetate

יחידות באריזה:

120 Tablets

תוצרת:

DR. REDDY`S LABORATORIES LTD

עלון מידע

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ABIRATRED
Abiraterone Acetate Tablets 250 mg
1
WHAT IS IN THIS LEAFLET
1.
What
_ABIRATRED _
is used for
2.
How
_ABIRATRED _
works
_3._
_ _
Before you use
_ABIRATRED _
_4._
_ _
How to use
_ABIRATRED _
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_ABIRATRED _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
1.
WHAT _ABIRATRED _IS USED FOR
It is used to treat prostate cancer that has
spread to other parts of the body.
Prostate cancer is a disease which only
affects men. Cancer begins to grow in
the prostate - a gland in the male
reproductive system.
2.
HOW _ABIRATRED _WORKS
_ABIRATRED _
stops your body from
making testosterone; this can slow the
growth of prostate cancer. When you
take this medicine your doctor will also
prescribe
another
medicine
called
prednisone or prednisolone. This is to
lower your chances of getting high
blood pressure, having too much water
in your body (fluid retention), or having
reduced levels of a mineral known as
potassium in your blood.
_3._
_ _
BEFORE YOU USE _ABIRATRED _
When you must not use it
-
if you are allergic to
_ABIRATRED _
or
any of the other ingredients of this
medicine.
-
if
you
are
a
woman,
especially
if
pregnant.
_ABIRATRED _
is for use in
male patients only.
-
if you have severe liver damage.
Before you start
_ABIRATRED _
Talk to your doctor or pharmacist before
taking
_ABIRATRED_
:
-
if you have been told you have high
blood pressure or heart failure or low
blood
potassium
(low
blood
potassium may increase the risk of
heart rhythm problems)
-
if you have liver problems
-
about the need to take this medicine
with prednisone or prednisolone
-
about
possible
effects
on
your
bones
-
if you have taken a medicine known
as
ketoconazole
in
the
past
for
prostate cancer
-
if you have high blood sugar.
Decrease
in
red
blood
cells,
sexual
dysfunction,
muscle
weakness
and/or
muscle pain may occur.
If you are not sure if any of the above
apply to you, talk to your do

מאפייני מוצר

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PRESCRIBING INFORMATION
ABIRATRED
ABIRATERONE ACETATE TABLETS 250 MG
COMPOSITION
Each film coated tablet contains:
Abiraterone Acetate 250 mg
Excipients: Lactose Monohydrate, Microcrystalline Cellulose,
Croscarmellose sodium, Povidone,
Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Magnesium Stearate,
Opadry White OY-58900 and
Purified Water.
Colour: Titanium Dioxide
Description: White to off white, oval shaped, film coated tablets,
debossed with “
“(logo)
on one side and “358” on other side.
CLINICAL INFORMATION
THERAPEUTIC INDICATION
ABIRATRED is indicated with prednisone or prednisolone for
• 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 (see section
Pharmacodynamic Properties).
• the treatment of mCRPC in adult men whose disease has progressed
on or after a docetaxel-based
chemotherapy regimen.
ABIRATRED 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.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 1000 mg (two 500 mg tablets or 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 prednisolone _
For mCRPC, ABIRATRED is used with 10 mg prednisone or prednisolone
daily.
For mHSPC, ABIRATRED is used with 5 mg prednisone or prednisolone
daily.
Medical castration with LHRH analogue should be continued during
treatment in patients not
surgically castrated.
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_Recommended monitoring _
Serum transaminases should be measured prior to starting treatment,
every two weeks for the first
three mon