ORALON DENTAL PASTE

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

TRIAMCINOLONE ACETONIDE

Saatavilla:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Kansainvälinen yleisnimi):

TRIAMCINOLONE ACETONIDE

Kpl paketissa:

5 gm

Valmistaja:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Pakkausseloste

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ORALON DENTAL PASTE
Triamcinolone Acetonide (0.1% w/w)
WHAT IS IN THIS LEAFLET:
1.
What Oralon Dental Paste is used for
2.
How Oralon Dental Paste works
3.
Before you use Oralon Dental Paste
4.
How to use Oralon Dental Paste
5.
While you are using Oralon Dental
Paste
6.
Side Effects
7.
Storage
and
Disposal
of
Oralon
Dental Paste
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ORALON DENTAL PASTE IS USED FOR
Oralon
dental
paste
is
indicated
as
adjunctive
treatment
and
temporary
relieving
inflammation
and
ulceration
inside
the
mouth that is
not related to
herpes infection.
HOW ORALON DENTAL PASTE WORKS
Triamcinolone
acetonide
is
the
active
ingredient
of
Oralon
Dental
Paste.
Triamcinolone
acetonide
is
used
for
narrowing the blood vessels and relieve
inflammation and itching on the skin or
mucous membranes.
BEFORE YOU USE ORALON DENTAL PASTE
_-When you must not use it _
• If you are allergic (hypersensitive) to
triamcinolone acetonide or any of the
other ingredients of Oralon Dental
Paste.
• If you have herpes lesions of known
viral origin.
_-Before you start to use it _
You must tell your doctor if you have
following
condition
as
Oralon
Dental
Paste should not be used in the following
condition:
i)
presence of infection.
ii)
tuberculosis (bacteria infection that
mainly affect the lung), stomach
ulcer, or diabetes.
If
there
is
no
symptoms
improvement
occurred in 7 days after you use Oralon
Dental
Paste,
you
should
contact
your
doctor as additional investigations into the
condition
of
oral
lesion
should
be
conducted by your doctor.
_Pregnancy and breastfeeding _
You should talk with your doctor if you
are
pregnant,
think
that
you
may
be
pregnant, planning to become pregnant, or
breast-feeding.
Oralon
Dental
Paste
should not be used in women of child-
bearing potential and particularly during
early
pregnancy
unless
the
potential
benefits outweighed the possible hazards.
_-Taking other medicines _
Always
inform
your

Valmisteyhteenveto

7015-04
ORALON Dental Paste
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
ORALON dental paste is Triamcinolone Acetonide 0.1% w/w in emollient
dental paste.
Each gram contains:
Triamcinolone
Acetonide………………………………………………1mg
This product contains gelatin of non-porcine origin.
PRODUCT DESCRIPTION:
A light brown paste in printed tubes with white caps.
PHARMACODYNAMICS
:
Triamcinolone acetonide is used in dermatology for its
anti-inflammatory, antipruritic and vasoconstrictive action on
the skin/mucous membranes.
PHARMACOKINETICS:
Topically applied triamcinolone acetonide is usually metabolised in
the skin. There is some systemic absorption through
the oral mucosa. Once the drug is absorbed into the systemic
circulation, it is bound to plasma proteins. It is mainly
metabolised in the liver.
INDICATION:
ORALON Dental Paste is indicated for adjunctive treatment and
temporary relief of symptoms associated with non-
herpetic, oral inflammatory and ulcerative lesions such as: recurrent
ulcerative stomatitis, erosive lichen planus, denture
stomatitis,
traumatic lesions
including denture sore spots,
desquamative
gingivitis
and stomatitis,
and aphthous
stomatitis.
RECOMMENDED DOSAGE:
Usual
dose:
Apply a small dab of the ORALON Dental Paste (about ½ cm) to the
lesion, two or three times a day, after meals,
and at bed time.
Applying the paste with a cotton applicator will help to eliminate any
possible absorption from contact with skin.
The paste should be pressed, not rubbed, on the lesion. Rubbing the
paste on the lesion will result in a granular, gritty
sensation and cause it to crumble. A smooth, slippery film forms after
application.
ROUTE OF ADMINISTRATION:
To be used topically, to the oral mucous membranes.
CONTRAINDICATIONS:
a)
The use of topical corticosteroids, is contraindicated in herpetic
lesions of known viral origin such as herpes
labialis, intraoral lesions such as primary herpetic gingival
stomatitis and herpanginas.
b)
Known hypersensitivity to any ingredient of the preparation.
W