Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Lactic Acid; SALICYLIC ACID
DKSH MALAYSIA SDN. BHD.
Lactic Acid; SALICYLIC ACID
15 ml
Delpharm Bladel B.V.
DUOFILM SOLUTION _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ Salicylic acid 16.7% w/w; Lactic acid 15.0% w/w WHAT IS IN THIS LEAFLET 1. What Duofilm Solution is used for 2. How Duofilm Solution works 3. Before you use Duofilm Solution 4. How to use Duofilm Solution 5. While you are using it 6. Side Effects 7. Storage and Disposal of Duofilm Solution 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DUOFILM SOLUTION IS USED FOR Duofilm Solution is indicated in the treatment of warts, corns and calluses. HOW DUOFILM SOLUTION WORKS Duofilm Solution contains two medicines called salicylic acid and lactic acid. It works by softening the skin of a wart, corn and callus, causing it to peel off. Duofilm Solution is used in the treatment of warts, corns and calluses. BEFORE YOU USE DUOFILM SOLUTION - _When you must not use it _ Do not use Duofilm Solution: • if you are allergic (hypersensitive) to salicylic acid, lactic acid or any other ingredients of Duofilm Solution. • if the wart, verruca, corn or callus or skin surrounding it, is red, irritated, broken or infected. • on moles, birthmarks, or warts with hairs growing from them, red edges or that are of an unusual colour. • on warts that are on your face, genital (sex) area or mucous membranes such as eyes, nose or mouth. • on warts that cover an area of the body more than 5 cm 2 (approximately the size of a postage stamp). • for diabetics or those suffering from poor blood circulation or poor sense of feeling (nerve damage) to the hands or feet. • for infants under 2 years old • for children or teenagers showing any signs of fever (raised temperature), who have a viral infection (such as the flu or chickenpox) or who have just recovered from any of these illnesses. There is no information about the safety of Duofilm Solution in pregnant women. Duofilm Solution is not recommended for use during pregnancy. The ingredients of Duofilm Solution may pass into breast milk. Breast-feeding is not recommended Pročitajte cijeli dokument
1. Product Name Duofilm Solution 2. Qualitative And Quantitative Composition Salicylic acid 16.7% w/w Lactic acid 15.0% w/w Excipient: Flexible collodion (contains pyroxylin, colophony, virgin castor oil, ethanol and ether). This product contains Ethanol 90%. 3. Product Description A yellowish to amber coloured clear viscous liquid with a strong odour ether. 4. Pharmacodynamics ATC Code Pharmacotherapeutic group: Wart and anti-corn preparations. ATC code: D11AF Mechanism of Action Topically applied salicylic acid is keratolytic. The keratolytic activity produces desquamation by solubilising the intercellular cement in the stratum corneum resulting in the shedding of skin scales. Lactic acid affects the keratinisation process, reducing the hyperkeratosis which is characteristic of warts, corns and calluses. At high concentrations it can cause epidermolysis, leading to the destruction of the keratotic tissue, and in the case of warts, of the causative virus. It also has antiseptic properties. Flexible collodion provides a viscous vehicle that allows accurate application of the active ingredients to the wart, corn or callus. It also forms a film that helps to hydrate and promote the destruction of hyperkeratotic tissue. 5. Pharmacokinetics Absorption Salicylic acid is absorbed through the skin; where detectable, maximum plasma levels are found 6 to 12 hours after application. Systemic absorption of salicylic acid has been reported to range from 9% to 25% after topical application of other salicylic acid-containing preparations. The extent of absorption is variable depending on the duration of contact and the vehicle. Despite percutaneous absorption, the systemic exposure is low given the low dose topically administered to small, localised areas of hyperkeratotic tissue. Human abdominal skin in a flow-through diffusion system was used to assess the in vitro percutaneous absorption of lactic acid. At a pH of 3, the amount of radioactivity detected in the receptor fluid, stratum corneum, epidermis, and dermis was 3.6, Pročitajte cijeli dokument