MEDIXON TABLET

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

METHYLPREDNISOLONE

Dostępny od:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (International Nazwa):

METHYLPREDNISOLONE

Sztuk w opakowaniu:

100Tablet Tablets

Wyprodukowano przez:

PT DEXA MEDICA

Ulotka dla pacjenta

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MEDIXON TABLET
Methylprednisolone (4 mg)
1
WHAT IS IN THIS LEAFLET:
1.
What Medixon is used for
2.
How Medixon works
3.
Before you use Medixon
4.
How to use Medixon
5.
While you are taking it
6.
Side effects
7.
Storage
and
disposal
of
Medixon
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MEDIXON IS USED FOR
Medixon is used in the treatment
of
various
conditions
such
as
allergy or inflammation.
HOW MEDIXON WORKS
Medixon
contains
a
corticosteroid.
It
decreases
the
body’s
immune
response
to
certain
diseases
and
reduces
symptoms such as swelling and
redness.
BEFORE YOU USE MEDIXON
_-When you must not take it _
Do not take Medixon if:
−
You
have
allergies
to
methylprednisolone
or
any
other steroid medicine or any
of the ingredients in Medixon.
An allergic reaction may cause
a
skin
rash
or
reddening,
swollen
face
or
lips
or
shortness of breath.
−
You
have
recently
had
any
vaccination.
−
You have any fungal infection.
−
You
have
bowel
or
stomach
ulcer, osteoporosis, history of
psychosis,
and
herpes
virus
infection, especially when you
take
Medixon
for
long-term
treatment.
If you get a rash or symptom of
an
infection,
tell
your
doctor
immediately.
_-Before you start to take it _
Talk
to
your
doctor
or
pharmacist
before
taking
Medixon if you have any of the
diseases or conditions below:
−
You
are
about
to
have
any
vaccination.
−
You have tuberculosis or you
have
suffered
tuberculosis
in
the past.
−
You
have
an
under-active
thyroid or liver scarring.
−
You have infection including
viral eye infection.
_-Taking other medicines _
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines, including medicines
obtained without a prescription.
This
could
affect
the
way
Medixon or the other medicine
works.
Inform your doctor if you are
taking:
-
Prednisolone
or
anti-
inflammatory
medicines
such
as
NSAID or aspirin.
-
Anti-diabetic
medicines.
-
Ciclosporin:
used
to
prevent

Charakterystyka produktu

SpecPacGen001814/7
Author(s):
29.10.2021, Helen Fransiska Manurung, Artwork Management Officer -
BTR,
Reviewed by:
Approved by:
Effective date
:
02.11.2021
02.11.2021, Riski Amanda Tambunan, Supervisor Packaging Design,
02.11.2021, RA Officer 03, Regulatory Affairs Officer,
Specification Packaging Material
E-67052-04, LEAFLET MEDIXON TABLET MALAYSIA
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
SpecPacGen001814/7
Approved :RA Officer 03, Regulatory Affairs Officer,
Effective date: 02.11.2021
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
SpecPacGen001814/7
Approved :RA Officer 03, Regulatory Affairs Officer,
Effective date: 02.11.2021
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
NO.
PARAMETERS
SPECIFICATION
1.
Material
HVS (Lihat CoA / _See CoA_)
2.
Gramatur / _Grammature_
54 – 66 gsm
3.
Dimensi panjang / _Length dimension_
149 – 151 mm
4.
Dimensi lebar / _Width dimension_
99 – 101 mm
5.
Arah serat / _Fiber direction_
Horisontal / _Horizontal_
6.
Warna / _Colour_
Lihat proof print / _See proof print_
7.
Redaksional / _Redactional_
Lihat proof print / _See proof print_
SpecPacGen001814/7
Approved :RA Officer 03, Regulatory Affairs Officer,
Effective date: 02.11.2021
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
HISTORY
REVISION
NO.
REVISION
DATE
DETAILS
REASON
00
-
-
Dokumen baru menggantikan
SPM-E-67052-01
-
Perubahan NIE Malaysia
CC001976
01
15-Jul-16
Penambahan keterangan tanggal revisi
terakhir dan perubahan distributor
Email RA 15 Juli 2016
02
22-Jul-16
Penambahan tanggal revisi terakhir
Approval Distributor
21 Juli 2016
03
29-Jan-18
-
Perubahan redaksional
TD Medixon 09.01.2018
-
Penghilangan ® setelah nama brand
Email Marketing OBU
22.03.2018
-
Perubahan dimensi
Mengikuti Drawing Leaflet
Cartoning IMA
-
Penambahan parameter warna dan
redaksional pada spesifikasi
MoM Packdev-TS
29.08.2017
04
07 Mei
2019
-
Perubahan dokumen menjadi general
use
-
Penambahan approval site
CC004303
05
22 Jun
2020
-
Revisi item number menjadi E-67052-
04
-