Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
Noripharma Sdn. Bhd.
DICLOFENAC SODIUM
15gm mcg/mL; 5gm mcg/mL; 10gm mcg/mL; 30gm mcg/mL; 50gm mcg/mL
Noripharma Sdn. Bhd.
Page 1 of 2 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 Przeczytaj cały dokument