KETAZON SHAMPOO

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

KETOCONAZOLE

থেকে পাওয়া:

SPG PHARMA (MALAYSIA) SDN BHD

INN (International Name):

KETOCONAZOLE

প্যাকেজ ইউনিট:

100 mL per BOTTLE

Manufactured by:

SIAM BHEASACH CO LTD

তথ্য লিফলেট

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
KETAZON SHAMPOO
Ketoconazole (20 mg/g)
_______________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What KETAZON is used for
2.
How KETAZON works
3.
Before you use KETAZON
4.
How to use KETAZON
5.
While you are using
KETAZON
6.
Side effects
7.
Storage and Disposal of
KETAZON
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT KETAZON IS USED FOR
KETAZON is an antifungal agent
used to treat and prevent skin
infections. Both skin and scalp can
be treated with the shampoo.
HOW KETAZON WORKS
KETAZON works by preventing
the growth of fungi or yeasts and
rapidly relieves scaling and
pruritus, which are usually
associated with your infection.
BEFORE YOU USE KETAZON
_- When you must not use it _
Do not use KETAZON if you are
allergic to ketoconazole or any
other ingredients listed at the end of
this leaflet.
_Pregnancy and lactation _
There is no known risk with the use
of KETAZON in pregnancy or
breast-feeding.
_- Before you start to use it _
Tell your doctor or pharmacist if
you have allergies to any other
medicines, preservatives or dyes.
_- Taking other medicines _
Tell your doctor or pharmacist if
you are on a topical corticosteroid
treatment. It is recommended that
the steroid therapy be gradually
withdrawn over a period of 2-3
weeks, while using KETAZON
prevent any potential rebound
effect.
HOW TO USE KETAZON
_- How much to use _
For topical use only.
Wash the infected areas of the skin
or hair with KETAZON and allow
the product to soak in for 3-5
minutes before rinsing. Usually, a
palmful of shampoo suffice for one
wash.
_FOR TREATMENT OF: _
Seborrhoeic dermatitis (reddish
brown-coloured skin with yellow or
white scales) and dandruff:
Apply twice weekly for 2-4 weeks
Pityriasis versicolor (brown or
white-coloured small skin patches):
Apply once daily for up to 5 days
_FOR PREVENTION: _
Once every 1 or 2 weeks as needs
to maintain control
_- When to use it

পণ্য বৈশিষ্ট্য

SCALE: (%)
TO
TO
01
02
03
04
05
06
07
08
09
10
11
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
ทะเบียนยา
16/07/19
22/07/19
18/09/2020
24/09/2020
26/01/2021
W 10.5 cm
H 27
cm
LEAFLET KETAZON SHAMPOO 2 G EXPORT MALAYSIA
FM-RD-DE-04-2
KETAZON-SHAMPOO-100-04-L-ENG-MY-A0004
KET-SHAM-100-04-L-ENG-MY-A0004
Drawing No.
KET-SHAM-100-04-L-ENG-MY-A0004
Sent date 29/01/2021
26/01/2021
UNDESIRABLE EFFECTS
Summary of Safety Profile
The adverse reactions tabulated below are
classified according to frequency and system
organ, from either clinical trial or post marketing
experiences.
SYSTEM
ORGAN
FREQUENCY
ADVERSE
REACTIONS
Immune system
disorders
Rare
: Hypersensitivity
Nervous system
disorders
Rare
: Dysgeusia
Infection and
Infestations
Uncommon
: Folliculitis
Eye disorders
Uncommon
Rare
: Increased
lacrimation
: Eye irritation
Skin and
subcutaneous
tissue disorders
Uncommon
Rare
Not known
: Skin burning
sensation,
alopecia,
dry skin, rash,
hair texture
abnormal
: Skin
exfoliation,
dermatitis
contact, skin
disorder, acne
: Angioedema,
urticaria, hair
colour changes
General
disorders
and
administration
site conditions
Uncommon
Rare
: Application site
reaction/
pruritus/
irritation/
erythema
: Application site
hypersensitivity/
pustules
OVERDOSE AND TREATMENT
In the event of accidental ingestion, supportive
and symptomatic measures should be carried
out. In order to avoid aspiration, neither eme-
sis nor gastric lavage should be instigated.
STORAGE CONDITIONS
Store below 30
°
C, protect from light and heat
SHELF LIFE
3 years
DOSAGE FORMS AND PACKAGING
AVAILABLE
Available in 100 mL per plastic bottle
DATE OF REVISION OF PI
Date of revision : 22/01/2021
MANUFACTURER :-
SIAM BHEASACH CO., LTD.
123 Soi Chokechairuammitr, Vibhavadi-Rangsit
Road, Chomphon, Chatuchak, Bangkok 10900
and 9