Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ADAPALENE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
ADAPALENE
15gm mcg/mL
GLENMARK PHARMACEUTICALS LTD
_Consumer Medication Information Leaflet (RiMUP)_ _ _ 1 DERIVA MS AQUEOUS GEL Adapalene Gel Microspheres 0.1% w/w WHAT IS IN THIS LEAFLET 1. What Deriva MS Aqueous Gel is used for 2. How Deriva MS Aqueous Gelworks 3. Before you use Adapalene Gel Microspheres 0.1 w/w 4. How to use Deriva MS Aqueous Gel 5. While you are using it 6. Side effects 7. Storage and Disposal of Adapalene Gel Microspheres 0.1 w/w 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DERIVA MS AQUEOUS GELIS USED FOR Deriva MS Aqueous Gel is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 12 years of age and older. Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples. It is not known if Deriva MS Aqueous Gel is safe and effective in children younger than 12 years of age HOW DERIVA MS AQUEOUS GEL WORKS The active substance in Deriva MS Aqueous Gel is adapalene which has an anti-inflammatory effect reducing soreness and irritation. BEFORE YOU USE ADAPALENE GEL MICROSPHERES 0.1 W/W - _When you must not use it _ Do not use Deriva MS Aqueous Gel if you are allergic to adapalene or any of the ingredients in this product. See the end of this Consumer Information Leaflet for a complete list of ingredients in Deriva MS Aqueous Gel. - _Before you start to use it _ Tell your doctor if you: have other skin problems, including eczema, seborrhoeic skin inflammation have any other medical conditions have severe forms of acne _Pregnancy, breast-feeding and _ _fertility _ It is not known if Deriva MS Aqueous Gel can harm your unborn baby. The use of Adapalene is not recommended during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Deriva MS Aqueous Gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use Deriva MS Aqueous Gel. To avoid contact exposure of the infant, application of Deriva MS Aqueous Gel to t Lees het volledige document
PE00000 MY PRODUCT REGISTRATION HOLDER Glenmark Pharmaceuticals (Malaysia) Sdn Bhn (660397-W) D-31-02. Menara Suezcap 1, No. 2, Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia SAME SIZE ARTWORK LEAFLET SIZE: 140 mm x 352 mm COMPOSITION: Adapalene 0.1% w/w (As Microspheres) In a aqueous gel base PRESERVATIVES: Methyl Hydroxybenzoate BP 0.1% w/w Phenoxyethanol BP 0.25% w/w PRODUCT DESCRIPTION: A printed carton containing an insert & printed lami tube containing opaque white smooth homogenous gel. GENERAL INFORMATION: Adapalene Gel microspheres, containing Adapalene in a MICROSPONGE DELIVERY SYSTEM, is used for the topical treatment of acne vulgaris. Each gram of Adapalene Gel microspheres contains adapalene 0.1% (1 mg), a retinoid analogue for the topical treatment of acne vulgaris, as microspheres a n d p r e s e r v a t i v e s , v i z . M e t h y l Hydroxybenzoate and phenoxyethanol. The chemical name of adapalene is 6-[3-(1- adamantyl)-4 methoxyphenyl]-2-naphthoic acid. Adapalene is a white to off- white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula of adapalene is C H O , and its molecular 28 28 3 weight is 412.52. Adapalene has the following structural formula: CLINICAL PHARMACOLOGY: PHARMACODYNAMICS: Adapalene is a retinoid analogue for the treatment of acne vulgaris. It is a naphthoic acid Adapalenetive with a methoxyphenyl adamantyl side chain. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris. Adapalene is a chemically stable derivatice of naphthoic acid that binds selectively to the nuclear retinoic acid receptor (RAR) subtypes RAR γ (found in dermal fibroblasts), activating genes responsible for cellular differentiation; it does not bind to cytosolic retinoid acid binding proteins. Adapalene is thought to modulate keratinisation Lees het volledige document