Hovid Gefitinib Tablets 250mg

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

Gefitinib

Inapatikana kutoka:

HOVID BERHAD

INN (Jina la Kimataifa):

Gefitinib

Vitengo katika mfuko:

30 Tablets; 30 Tablets

Viwandani na:

Qilu Pharmaceutical (Hainan) Co., Ltd.

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOVID GEFITINIB TABLETS 250MG
GEFITINIB (250 MG)
1
WHAT IS IN THIS LEAFLET
1.
What
Hovid
Gefitinib
Tablets
250mg is used for
2.
How
Hovid
Gefitinib
Tablets
250mg works
3.
Before
you
use
Hovid
Gefitinib
Tablets 250mg
4.
How
to
use
Hovid
Gefitinib
Tablets 250mg
5.
While
you
are
using
Hovid
Gefitinib Tablets 250mg
6.
Side effects
7.
Storage
and
Disposal
of
Hovid
Gefitinib Tablets 250mg
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HOVID GEFITINIB TABLETS 250MG
IS USED FOR
Hovid Gefitinib Tablets 250mg is used
to treat advanced non-small cell lung
cancer,
which
is
one
type
of
lung
cancer.
HOW HOVID GEFITINIB TABLETS 250MG
WORKS
Hovid
Gefitinib
Tablets
250mg
contains the active substance, gefitinib,
which
blocks
a
protein
called
“epidermal
growth
factor
receptor”
(EGFR). This protein is involved in the
growth and spread of cancer cells.
BEFORE
YOU
USE
HOVID
GEFITINIB
TABLETS 250MG
_ _
_- When you must not use it _
Do not take Hovid Gefitinib Tablets
250mg if you are allergic to gefitinib or
any
other
ingredients
used
in
Hovid
Gefitinib Tablets 250mg, as per listed
in the last page of this leaflet. If you
think you may be allergic, ask your
doctor for advice.
Hovid Gefitinib Tablets 250mg is not
recommended
for
use
in
children
or
adolescents.
_- Before you start to use it _
Before taking Hovid Gefitinib Tablets
250mg:
•
Tell your doctor if you have or
have had any other lung diseases,
other than your lung cancer. Some
of
them
may
worsen
during
treatment
with
Hovid
Gefitinib
Tablets 250mg.
•
Tell
your
doctor
if
you
are
pregnant
or
trying
to
become
pregnant.
You
should
avoid
becoming
pregnant
during
treatment
with
Hovid
Gefitinib
Tablets 250mg.
•
Tell your doctor if you are breast-
feeding.
For
the
safety
of
your
baby,
you
should
discontinue
breast-feeding
during
treatment
with
Hovid
Gefitinib
Tablets
250mg.
_- Taking other medicines _
Please inform your doctor if you are
taking
or
have
taken

Tabia za bidhaa

HOVID GEFITINIB TABLETS 250 MG
VIGEFxx-0
DESCRIPTION
Round, biconvex face, brown film-coated, debossed with “QL” on one
side
and plain on the other side.
COMPOSITION
Each film-coated tablet contains: Gefitinib 250 mg.
PHARMACODYNAMICS
Hovid Gefitinib belongs to drug class antineoplastic agents or protein
kinase
inhibitors.
The epidermal growth factor (EGF) and its receptor (EGFR [HER1;
ErbB1])
have been identified as key drive in the process of cell growth and
proliferation for normal and cancer cells. EGFR activating mutation
within a
cancer cell is an important factor in promotion of tumour cell growth,
blocking
of apoptosis, increasing the production of angiogenic factors and
facilitating
the processes of metastasis.
Gefitinib is a selective small molecule inhibitor of the epidermal
growth factor
receptor tyrosine kinase and is an effective treatment for patients
with
tumours with activating mutations of the EGFR tyrosine kinase domain
regardless of line of therapy. No clinically relevant activity has
been shown in
patients with known EGFR mutation-negative tumours.
Most NSCLC tumours with sensitising EGFR kinase mutations eventually
develop resistance to gefitinib treatment, with a median time to
disease
progression of 1 year.
PHARMACOKINETICS
ABSORPTION AND DISTRIBUTION
Following oral administration of gefitinib, absorption is moderately
slow and
peak plasma concentrations of gefitinib typically occur at 3 to 7
hours after
administration. Exposure to gefitinib is not significantly altered by
food.
DISTRIBUTION
Gefitinib has a mean steady-state volume of distribution of 1400 l
indicating
extensive distribution into tissue. Plasma protein binding is
approximately
90%. Gefitinib binds to serum albumin and alpha 1-acid glycoprotein.
BIOTRANSFORMATION
Gefitinib is extensively metabolised in humans. Five metabolites have
been
fully identified in excreta and 8 metabolites in plasma where the
major
metabolite identified was O-desmethyl gefitinib.
ELIMINATION
Gefitinib is excreted mainly as metabolites via the fa