VOLNAC GEL 1% ww

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

DICLOFENAC SODIUM

Saatavilla:

Noripharma Sdn. Bhd.

INN (Kansainvälinen yleisnimi):

DICLOFENAC SODIUM

Kpl paketissa:

15gm mcg/mL; 5gm mcg/mL; 10gm mcg/mL; 30gm mcg/mL; 50gm mcg/mL

Valmistaja:

Noripharma Sdn. Bhd.

Valmisteyhteenveto

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VOLNAC GEL 1% W/W
COMPOSITION: Each gram contains Diclofenac Sodium 10mg.
DESCRIPTION: A clear, colourless to light pink-orange, smooth gel.
PHARMACODYNAMICS:
Diclofenac sodium is non-steroidal anti-inflammatory drug (NSAID) with
marked analgesic, antipyretic and
anti-inflammatory
properties.
It
inhibits
cyclo-oxygenase
which
results
in
a
marked
reduction
in
prostaglandin synthesis. Diclofenac inhibits the enzyme,
cyclooxygenase (COX), an early component of
the arachidonic acid cascade, resulting in the reduced formation of
prostaglandins, thromboxanes and
prostacylin.
PHARMACOKINETICS:
Diclofenac is absorbed through the skin. The topical application of
diclofenac sodium allows the
percutaneous absorption of therapeutic concentrations of the active to
penetrate to, and accumulate at,
the target site of action. The dose to be delivered in a concentration
of a 1% gel, is comparable to the
normal daily doses of oral administration. As with other
percutaneously applied NSAIDs, it is the
concentration reached at the target area that is important for the
therapeutic action rather than the
plasma concentration. Hence, the systemic load produced by oral
parenteral administration can be avoided
through local application.
INDICATION:
Topical treatment of inflammatory or pain conditions caused by chronic
rheumatoid arthritis,
degenerative arthritis and soft tissue rheumatism.
RECOMMENDED DOSE:
Depending on the size of the painful area to be treated, 2 - 4g VOLNAC
should be applied 3-4 times daily
to the affected sites and gently rubbed in. The duration of treatment
depends on the indication and the
patient’s response. It is advisable to review the treatment after
two weeks. VOLNAC can also be used as
an adjunct with other dosage forms of VOLNAC. No dosage
recommendations and indications have been
established to date for the use of VOLNAC in children.
ROUTE OF ADMINISTRATION: Topical administration
CONTRAINDICATION:
Hypersensitivity to diclofenac and NSAID.
VOLNAC should not be administered in patients who have