MEDINAZINE ORAPASTE 0.1%WW

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
10-03-2022
Ciri produk Ciri produk (SPC)
31-07-2022

Bahan aktif:

DEXAMETHASONE

Boleh didapati daripada:

World Medicare Supplies Sdn Bhd

INN (Nama Antarabangsa):

DEXAMETHASONE

Unit dalam pakej:

1 X 5 gm

Dikeluarkan oleh:

Yuan Chou Chemical & Pharmaceutical Co., Ltd.

Risalah maklumat

                                MEDINAZINE
ORAPASTE 0.1%W/W
Dexamethasone
(
1.0mg in each gram
)
1
_C_
_ONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_
_)_
WHAT IS IN THIS LEAFLET
1.
What _Medinazine_ is used for
2.
How _Medinazine_ works
3.
Before you use _Medinazine_
4.
How to use _Medinazine_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Medinazine_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _Medinazine_ IS USED FOR
Medinazine (Dexamethasone) is used for the
treatment of intractable stomatitis
(inflammation in the mouth) or glossitis
(inflammation of the tongue) associated
with erosion or ulceration
HOW _Medinazine_ WORKS
Dexamethasone is a corticosteroid that
prevents the release of substances in the
body that cause inflammation.
BEFORE YOU USE _Medinazine_
-
_When you must not use it_
You should not use this medication if you
are allergic to dex
a
m
e
tha
s
one, or if you
have
a fungal infection anywhere in your
body.
Unsuitable for phenylketonuric
_Pregnancy and lactation _
Do not use _Medinazine_ if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not use _Medinazine_ if you are breast-
feeding. Ask your doctor or pharmacist for
advice before taking any medicine.
-
_Before you start to use it_
Before you start to use this medication,
let your doctor know if:
-
You have any other medical
conditions.
-
You have unusual stress, such as
serious illness, fever or infection, or
if you have surgery or a medical
emergency.
-
You intend to take any vaccine
during your treatment with this
medication.
-
You have had any illness or
infection within the past several
weeks.
-
_Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE _Medinazine_
-
_How much to use_
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
und
                                
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Ciri produk

                                YUAN CHOU CHEMICAL & PHARMACEUTICAL CO., LTD
NO. 272 , NANGANG 3RD RD., NANTOU CITY , NANTOU COUNTY 54067, TAIWAN
R.O.C
PACKAGE INSERT
1. Name of the medicinal product
Medinazine Orapaste 0.1%w/w
2. Qualitative and quantitative composition
Each gram contains Dexamethasone 1.0mg
3. Pharmaceutical form
Orabase
Description: Cream white color orabase and smells of strawberry.
4. Clinical particulars
4.1 Therapeutic indications
Intractable stomatitis or glossitis associated with erosion or
ulceration.
4.2 Posology and method of administration
Usually apply an adequate amount of Medinazine to the affected area 1
to several times daily. The
dose may be increased or decreased depending on the condition of the
patient.
4.3 Contraindications
Medinazine should not be used on the following patients: Patients with
tuberculosis, viral or
other purulent infections of the oral cavity.
Patients with a past history of hypersensitivity to Medinazine.
4.4 Special warnings and precautions for use
Unsuitable for phenylketonurics.
No food or fluid should be ingested for a short time after application
of Medinazine Orapaste.
Medinazine Orapaste should by no means be applied to the eye.
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient
presents with symptoms such as blurred vision or other visual
disturbances, the patient should be
considered for referral to an ophthalmologist for evaluation of
possible causes which may include
cataract, glaucoma or rare diseases such as central serous
chorioretinopathy (CSCR) which have
been reported after use of systemic and topical corticosteroids
4.5 Interaction with other medicinal products and other forms of
interaction
Medinazine may interact with the following drugs and products:
•
Aspirin,
Cyclosporine,
Diabetes
medications,
Diuretic,
Ketoconazole,
Phenobarbital,
Phenytoin
•
Rifampin, Warfarin
4.6 Pregnancy, breast-feeding and children
Pregnancy:
The safety of Medinazine when used during pregnancy has not yet been
established. Its prolonged
use on 
                                
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