DYNA ORAPASTE

Country: Մալայզիա

language: անգլերեն

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

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PIL PIL (PIL)
14-02-2023
SPC SPC (SPC)
14-02-2023

active_ingredient:

TRIAMCINOLONE ACETONIDE

MAH:

DYNAPHARM (M) SDN BHD

INN:

TRIAMCINOLONE ACETONIDE

units_in_package:

10gm mcg/mL

manufactured_by:

DYNAPHARM (M) SDN BHD

PIL

                                DYNA ORAPASTE
Triamcinolone Acetonide (0.1% w/w)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Dyna Orapaste is used for
2.
How Dyna Orapaste works
3.
Before you used Dyna Orapaste
4.
How to use Dyna Orapaste
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Dyna
Orapaste
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DYNA ORAPASTE IS USED FOR
Dyna Orapaste indicated for adjunctive
treatment and for temporary relief of
symptoms associated oral inflammatory
lesion and ulcerative lesions resulting
from trauma.
HOW DYNA ORAPASTE WORKS
Triamcinolone provides a synthetic
corticosteroid with mark anti-
inflammatory action. It also provides a
soothing and protective covering, which
augments the effects of the steroid.
BEFORE YOU USE DYNA ORAPASTE
-
_When you must not use it _
Do not use Dyna Orapaste if you have
known hypersensitivity to
Triamcinolone, corticosteroids,
propylene glycol or other ingredients
listed in this leaflet.
_ _
_Pregnancy and lactation _
Tell your doctor if you are pregnant,
think you may be pregnant or planning
to get pregnant or if you are
breastfeeding. Caution should be
exercised when used by nursing
mothers.
Infants born of the mothers who have
received substantial doses of
corticosteroids during pregnancy should
be carefully observed for signs of
underactive adrenal glands such as
hypoadrenalism (weight loss, dizziness,
stomachache, patches of darker skin).
-
_Before you start to use it _
Tell your doctor or pharmacist if you
have any of the following conditions:
-
Tuberculosis (bacterial infection that
mainly affects the lungs)
-
Stomach or intestinal ulcer
-
Diabetes
-
Viral infection
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescriptions from a
pharmacy, supermarket or health food
shop. _ _
HOW TO USE DYNA ORAPASTE
-
_How much to use _
Follow all directions given to you by
your doctor and pharmacists care
                                
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SPC

                                DYNA ORAPASTE
MAL19984055AZ
DESCRIPTION:
GEL
Colour
:
Natural
Flavour
:
Mint
CONTAINS:
Triamcinolone (as Acetonide) ............................ 0.1% w/w
PHARMACODYNAMICS:
Triamcinolone provides a synthetic corticosteroid with marked
anti-inflammatory action. The synthetic analogues are
primarily used for their potent anti-inflammatory effects in disorders
of many organ systems. By using Triamcinolone-
containing gel, the possibility of systemic effects arising from
ingested medication is thereby reduced. Furthermore,
Triamcinolone-containing gel provides a soothing and protective
covering, which augments the effects of the steroid.
PHARMACOKINETICS:
The absorption and fate of Triamcinolone is similar to
corticosteroids. When administered by topical application
particularly under an occlusive dressing or when the skin is broken,
or as a pulmonary aerosol inhalation or a rectal
enema, sufficient corticosteroid may be absorbed to give systemic
effects. Corticosteroids in the circulation are
extensively bound to plasma proteins, mainly to globulin and less so
to albumin. The corticosteroid-binding globulin
has high affinity but low binding capacity, while the albumin has low
affinity but large binding capacity. Only unbound
corticosteroid has pharmacological effects or is metabolised.
Corticosteroids are metabolised mainly in the liver but
also in the kidney, and are excreted in the urine. Triamcinolone is
reported to have a biological half-life in plasma of
about 300 minutes. It is bound to plasma albumin to a much smaller
extent than hydrocortisone.
INDICATIONS:
Indicated for adjunctive treatment and for temporary relief of
symptoms associated with oral inflammatory lesions
and ulcerative lesions resulting from trauma.
RECOMMENDED DOSAGE:
Apply a small dab of Triamcinolone-containing gel to the lesion. A
larger quantity may be required for coverage of
some lesions. For optimal results use only enough to coat the lesion
with a thin film. The gel should be applied at
bedtime to permit steroid contact with the lesion
                                
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