Voltran Kool Gel Diclofenac Sodium 1%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC DIETHYLAMINE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

DICLOFENAC DIETHYLAMINE

Unit dalam pakej:

25gm mcg/mL; 50gm mcg/mL

Dikeluarkan oleh:

The United Drug (1996) Co.,Ltd.

Risalah maklumat

VOLTRAN KOOL
® GEL
_CONSUMER_
_ _
_MEDICATION_
_ _
_INFORMATION_
_ _
_LEAFLET_
_ _
_(RIMUP)_
Diclofenac sodium (1% w/w)
WHAT IS IN THIS LEAFLET
1.
What Voltran Kool Gel is used
for
2.
How Voltran Kool Gel works
3.
Before you use Voltran Kool Gel
4.
How to use Voltran Kool Gel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Voltran Kool Gel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT VOLTRAN KOOL GEL IS USED FOR
For the relief of pain, inflammation and
swelling in: post- traumatic
inflammation of the tendons, ligaments,
muscles, and joints, e.g., due to sprains,
strains, and bruises, or backache;
localized forms of soft-tissue
rheumatism, e.g. tendinitis, tennis
elbow; localised and mild arthritis.
HOW VOLTRAN KOOL GEL WORKS
Voltran Kool Gel is an anti-
inflammatory and analgesic preparation
for topical application. The non-greasy
gel preparation is easy to rub into the
skin, and its aqueous-alcohol base gives
it a soothing and cooling effect. In
inflammation of traumatic or rheumatic
origin, it relieves pain, reduces oedema,
and also affords effective relief from
tenderness and pain on movement.
BEFORE YOU USE VOLTRAN KOOL GEL
-
_When you must not use it_
_ _
Voltran Kool Gel should not be
used by anyone who:
•
is allergic to diclofenac or to any of
the ingredients of the medication.
•
experiences asthma attacks,
itchiness, or runny nose after taking
acetylsalicylic acid or other NSAIDs.
-
_Before you start use it_
_ _
Inform your physician of any medical
conditions or allergies you may have,
any medications you are taking,
whether you are pregnant or breast-
feeding, and any other significant
facts about your health.
These factors may affect how you
should use this medication.
-
_Taking other medicines_
_ _
No drug interactions have been
reported.
HOW TO USE VOLTRAN KOOL GEL
-
_How much to use_
_ _
Apply 2-4 g of Voltran Kool Gel, 3-
4 times daily to the affected sites and
rub in gently.
-
_When to use it_
_ _
Voltra

Ciri produk

PRODUCT NAME :
Voltran Kool
NAME AND STRENGTH OF ACTIVE SUBSTANCE :
Diclofenac Diethylammonium 1.16 % w/w equivalent to Diclofenac Sodium
1.00 % w/w.
PRODUCT DESCRIPTION :
White gel with a characteristic odor, non-greasy.
PHARMACODYNAMICS :
Voltran Kool is an anti-inflammatory and analgesic preparation for
topical application. The
white, creamy, non-greasy preparation is easy to rub into the skin,
and its aqueous-alcohol
base gives it a soothing and cooling effect. In inflammation of
traumatic or rheumatic origin,
it relieves pain, reduces oedema, and also affords effective relief
from tenderness and pain
on movement.
PHARMACOKINETICS :
Absorption: The amount of diclofenac absorbed through the skin is
proportional to the contact
time and skin area covered with Voltran Kool, and depends on the total
topical dose and on
skin hydration.
Distribution: Diclofenac can be detected in the plasma, synovial
tissue and synovial fluid after
topical application of Voltran Kool to the wrists and knees. Peak
plasma concentration of
diclofenac are about 100 times lower after topical application of
Voltran Kool than after oral
administration of tablets. 99.7 % of diclofenac binds to serum
proteins, mainly to albumin (99.4%)
Metabolism: Biotransformation of diclofenac takes place partly by
glucuronidation of the intact
molecule, but mainly by single or multiple hydroxylation resulting in
several phenolic metabolites,
most of which are converted to glucuronide conjugates. Two of these
phenolic metabolites
are biologically active, but to much lesser extent than diclofenac.
Elimination: Total systemic clearance of diclofenac from the plasma is
263 + 56mL/min (mean
value + standard deviation). The terminal plasma half-life is 1-2 hrs.
Four of the metabolites,
including the 2 active metabolites, also have a short plasma half-life
(1-3 hrs). One metabolite,
3’-hydroxy-4’-methoxydiclofenac, has a much longer half-life, but
this metabolite is virtually
inactive. Diclofenac and its metabolites are excreted mainly in the
urine.
No accum