Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOBETASOL PROPIONATE
ZUELLIG PHARMA SDN BHD
CLOBETASOL PROPIONATE
125 ml; 30 ml; 60 ml
LABORATORIES GALDERMA
1 _Consumer Medication Information Leaflet (RiMUP) _ CLOBEX ® SHAMPOO Clobetasol propionate (0.05% w/w) What is in this leaflet 1. What Clobex ® Shampoo is used for 2. How Clobex ® Shampoo works 3. Before you use Clobex ® Shampoo 4. How to use Clobex ® Shampoo 5. While you are using it 6. Side Effects 7. Storage and Disposal of Clobex ® Shampoo 8. Product Description 9. Manufacturer and Product registration holder 10. Date of revision WHAT CLOBEX ® SHAMPOO IS USED FOR Clobex ® Shampoo is used in adult for a short term to treat moderate to severe scalp psoriasis. HOW CLOBEX® SHAMPOO WORKS Clobex ® Shampoo contains clobetasol propionate which reduces the redness, itching and swelling. This medication is a very strong topical corticosteroid. BEFORE YOU USE CLOBEX® SHAMPOO _- When you must not use _ Do not use Clobex ® Shampoo if you are allergic to any of its ingredients, or any other corticosteroids. Ask your doctor or pharmacist if you need a list of other corticosteroids. Shampoo is not recommended for use by people under 18 years of age. _- Before you start to use it _ Tell your doctor: • If you are pregnant, think you are pregnant. Talk with your doctor before using Clobex ® Shampoo or if you are already using Clobex ® Shampoo. It is not known if Clobex ® Shampoo can harm your unborn baby. • If you are breastfeeding. It is not known if Clobex ® Shampoo passes into your milk, and if it can harm your baby. Clobex ® Shampoo should be used cautiously during pregnancy and breastfeeding only if the potential benefit justifies the potential risk to the baby. • If you think you have an infection on your scalp. You may need another medicine to treat the scalp infection before you use Clobex ® Shampoo. Manifestations of Cushing’s syndrome, high blood sugar level, and presence of sugar in the urine can also be produced in some people by systemic absorption of topical corticosteroids while on treatment. Conditions which increase systemic absorption include the application of the more potent cortic Przeczytaj cały dokument
NOTICE RECTO 180x315 PLAN n° MT.09.DRA.0352.R02.2 S H A M P O O C L O B E X ® ( c l o b e t a s o l p r o p i o n a t e ) S h a m p o o , 0 . 0 5 % Product code: MOCK UP Product description: CLOBEX SHA Market: EX2 Article: Leaflet Flat size: 180x315 Font size: 8 pt Fold size: 180x26,25 Pharmacode: TBD DIELINES GRAPHIC DESIGNER: Bérangère BLANCO INDUSTRIALIZATION DEPARTMENT LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN - FRANCE PMS 432U CLOBEX ® (CLOBETASOL PROPIONATE) SHAMPOO, 0.05% Rx Only For External Use Only. Not for Ophthalmic Use. DESCRIPTION: CLOBEX ® (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti- inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11ß, 17-dihydroxy-16ß- methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula: Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C 25 H 32 CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each mL of CLOBEX ® (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, 0.05%, in a shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate. It is a translucent, colourless to pale yellow viscous liquid, with alcoholic odour. CLINICAL PHARMACOLOGY: Like other topical corticosteroids, CLOBEX ® (clobetasol propionate) Shampoo, 0.05%, has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that thes Przeczytaj cały dokument