Dexaltin Oral Paste

Maa: Malesia

Kieli: englanti

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

Osta se nyt

Lataa Pakkausseloste (PIL)
22-02-2019
Lataa Valmisteyhteenveto (SPC)
14-08-2020

Aktiivinen ainesosa:

DEXAMETHASONE

Saatavilla:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Kansainvälinen yleisnimi):

DEXAMETHASONE

Kpl paketissa:

2g x 1units Units; 2g x 50units Units

Valmistaja:

Teika Pharmaceutical Co., Ltd

Pakkausseloste

                                DEXALTIN ORAL PASTE
Dexamethasone (1mg/g)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
What is in this leaflet
1.
What Dexaltin is used for
2.
How Dexaltin works
3.
Before you use Dexaltin
4.
How to use Dexaltin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Dexaltin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DEXALTIN IS USED FOR
Dexaltin (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 DEXALTIN_ _WORKS
Dexamethasone is a corticosteroid that
prevents the release of substances in the
body that cause inflammation.
BEFORE YOU USE DEXALTIN
-
_When you must not use it _
You should not use this medication if
you are allergic to dexamethasone, or
if you have a fungal infection
anywhere in your body.
_ _
_ _
_Pregnancy and lactation _
Do not use
_Dexaltin _
if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not use
_Dexaltin_
if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
-
_Before you start use it _
Before you start to use this medication,
let your doctor know if:
- you have any other medical
conditions
- you have any 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 DEXALTIN
-
_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
understand the instructions on the
label, ask your doctor or pharmacist
for help.
-
_When to
                                
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Valmisteyhteenveto

                                表
天
297.0
210.0
品
名
デキサルチン口腔用 1mg(輸出)
制作日
MC
2020.7.28
C
本コード
校
作業者印 AC
仮コード
0114W07273711
初校
島
倉
色
調
スミ
トラップ
(
)
角度
srwd0
APP.TB
COMPOSITION
Dexaltin Oral Paste contains the following components.
ACTIVE INGREDIENT AND CONTENT
DEXAMETHASONE 1.0 MG/G
INACTIVE INGREDIENT
LIQUID PARAFFI N, SODIUM POLYACRYLATE, HYDROCARBON
GEL
EFFICACY AND INDICATIONS
Intractable stomatitis or glossitis associated with erosion or
ulceration.
DOSAGE
Usually apply an adequate amount of Dexaltin Oral Paste to the
affected area 1
to several times daily. The dose may be increased or decreased
depending on the
condition of the patient.
CONTRAINDICATIONS
DEXALTIN ORAL PASTE SHOULD NOT BE USED ON THE FOLLOWING PATIENTS:
(1)
Patients with tuberculous, viral or other purulent infections of the
oral cavity.
(2)
Patients with a past history of hypersensitivity to Dexaltin Oral
Paste.
SIDE EFFECTS
No severe side effects of Dexaltin Oral Paste have been reported
except for the
withdrawal of the drug from one patient for a complaint of numbness at
the site of
application.
Adverse reactions
(1)
Infection of the oral cavity: Fungal or bacterial infection of the
oral cavity may
occur in the course of treatment with Dexaltin Oral Paste. In case
that any symptom
or sign of such an infection has appeared, an appropriate antifungal
or antibacterial
treatment should concomitantly be instituted. In cases where the
symptoms or signs
of the infection fail to subside rapidly, withdraw Dexaltin Oral
Paste.
(2)
Hypersensitivity: On manifestation of any allergic reaction, withdraw
Dexaltin
Oral Paste.
(3)
Function of the pituitary-adrenocortical system: The prolonged use of
Dexaltin
Oral Paste may be associated with hypofunction of the
pituitary-adrenocortical
system.
(4)
Vision, blurred
PREGNANCY AND LACTATION
The safety of Dexaltin Oral Paste when used during pregnancy has not
yet been
established. Its prolonged use on pregnant women or women suspected of
pregnancy
                                
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