RILTARED 150 (Erlotinib 150 mg Film Coated Tablets)

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

ERLOTINIB HYDROCHLORIDE

Saatavilla:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Kansainvälinen yleisnimi):

ERLOTINIB HYDROCHLORIDE

Kpl paketissa:

30 Tablets

Valmistaja:

DR. REDDY'S LABORATORIES LIMITED

Pakkausseloste

_Consumer Medication Information Leaflet (RiMUP) _
1
RILTARED 25 (ERLOTINIB FILM-COATED TABLETS 25MG)
RILTARED 100 (ERLOTINIB FILM-COATED TABLETS 100MG)
RILTARED 150 (ERLOTINIB FILM-COATED TABLETS 150MG)
_Contains active ingredient Erlotinib Hydrochloride (25mg, 100mg,
150mg as Erlotinib) _
_ _
WHAT IS IN THIS LEAFLET
1.
What Riltared is used for
2.
How Riltared works
3.
Before you use Riltared
4.
How to use Riltared
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Riltared
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
1. WHAT RILTARED IS USED FOR
Riltared contains the active
ingredient erlotinib hydrochloride
Riltared is indicated for adults. This
medicine can be prescribed to you if
you have non-small cell lung cancer at
an
advanced
stage.
It
can
be
prescribed as initial therapy if your
cancer
cells
have
specific
EGFR
mutations. It can also be prescribed if
your
disease
remains
largely
unchanged
after
initial
chemotherapy,
or
if
previous
chemotherapy has not helped to stop
your disease.
Riltared is also used in combination
with gemcitabine for the treatment of
pancreatic cancer.
This medicine is available only with a
doctor's prescription.
2. HOW RILTARED WORKS
As a targeted cancer treatment,
Riltared targets a specific protein on the surface of the cancer ce
3. BEFORE YOU USE RILTARED
-
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE RILTARED IF
:
1.
you have had an allergic reaction
to Riltared or any ingredients listed
at the end of this leaflet
2.
the package is torn or shows signs
of tampering.
3.
the expiry date (EXP) printed on
the pack has passed.
If
you
take
this
medicine
after
the
expiry
date
has
passed,
it
may
not
work as well.
If you are not sure if you should be
taking Riltared, talk to your doctor.
_USE IN CHILDREN _
Do not give Riltared to children. Safety
and effectiveness in patients less than
18
years
of
age
have
not
been
established.
-
_BEFORE YOU START TO USE IT _
Your doctor must know about all the
following
before

Valmisteyhteenveto

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PRESCRIBING INFORMATION
RILTARED 25 (ERLOTINIB FILM-COATED TABLETS 25 MG)
RILTARED 100 (ERLOTINIB FILM-COATED TABLETS 100 MG)
RILTARED 150 (ERLOTINIB FILM-COATED TABLETS 150MG)
COMPOSITION
_RILTARED 25 (Erlotinib Film-Coated Tablets 25 mg)_
:
Each Film-Coated Tablet Contains: Erlotinib Hydrochloride 27.3 mg
equivalent to Erlotinib 25 mg
_RILTARED 100 (Erlotinib Film-Coated Tablets 100 mg)_
:
Each Film-Coated Tablet Contains: Erlotinib Hydrochloride 109.30 mg
equivalent to Erlotinib 100 mg
_RILTARED 150 (Erlotinib Film-Coated Tablets 150 mg)_
:
Each Film-Coated Tablet Contains: Erlotinib Hydrochloride 163.90 mg
equivalent to Erlotinib 150 mg
PHARMACEUTICAL FORM
Film Coated Tablet
_RILTARED 25 (Erlotinib Film-Coated Tablets 25 mg)_
: White to off white film coated round tablets with
‘E’ de-bossed on one side and plain on other side.
_RILTARED 100 (Erlotinib Film-Coated Tablets 100 mg)_
: White to off white film coated round tablets with
‘E’ de-bossed on one side and ‘100’ on other side.
_RILTARED 150 (Erlotinib Film-Coated Tablets 150 mg)_
: White to off white film coated round tablets with
‘E’ de-bossed on one side and ‘150’ on other side.
CLINICAL INFORMATION
THERAPEUTIC INDICATION
Non-small cell lung cancer
Riltared is indicated for the first-line treatment of patients with
locally advanced or metastatic non-small
cell lung cancer (NSCLC) with EGFR activating mutations.
Riltared is indicated for maintenance treatment in patients with
locally advanced or metastatic NSCLC with
EGFR activating mutations who have not progressed after firstline
chemotherapy.
Riltared is also indicated for the treatment of patients with locally
advanced or metastatic NSCLC after
failure of at least one prior chemotherapy regimen.
Pancreatic Cancer
Riltared in combination with gemcitabine is indicated for the
treatment of patients with locally advanced,
unresectable or metastatic pancreatic cancer
POSOLOGY AND METHOD OF ADMINISTRATION
Standard Dosage
_Non-small cell lung cancer _
EGFR mutation testing s