国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
ANTAH PHARMA SDN. BHD.
DICLOFENAC SODIUM
30gm mcg/mL
DAR AL DAWA DEVELOPMENT &INVESTMENT CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DICLOGESIC _®_ _ _GEL Diclofenac Sodium 1% w/w 1 WHAT IS IN THIS LEAFLET 1. What Diclogesic® Gel is used for 2. How Diclogesic Gel works 3. Before you use Diclogesic Gel 4. How to use Diclogesic Gel 5. While you are using Diclogesic Gel 6. Side Effects 7. Storage and Disposal of Diclogesic Gel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DICLOGESIC GEL IS USED FOR Diclogesic Gel is used for the external treatment of pain, inflammation and swelling in: - Injuries of tendons, ligaments, muscles and joints, e.g. sprains, bruises, strains, or back pain after sport or accidents. - Localized forms of soft tissue rheumatism such as tendinitis (tennis elbow), shoulder-hand syndrome, bursitis, periarthropathies and for the symptomatic treatment of osteoarthritis of small and medium- sized joints located close to the skin such as the finger joints or knee joints. HOW DICLOGESIC GEL WORKS Diclogesic Gel contains the active ingredient diclofenac, which belongs to a group of medicines called non- steroidal anti-rheumatic drugs (analgesic and anti-inflammatory medicines). Diclogesic gel has analgesic and anti- inflammatory properties and has a soothing and cooling effect due to the aqueous-alcoholic base. BEFORE YOU USE DICLOGESIC GEL _-_ _ _ _When you must not use it _ Diclogesic Gel should not be used in cases of hypersensitivity to the active substance diclofenac or other analgesic and anti-inflammatory agents (especially acetylsalicylic acid /aspirin and ibuprofen) and in case of hypersensitivity to propylene glycol, isopropyl alcohol or other excipients. Such hypersensitivity is expressed for example by asthma, respiratory problems, skin rash, urticarial, swelling of the face and tongue, rhinorrhea (runny nose). Diclogesic Gel should not be used during the 3 rd trimester of pregnancy. _-_ _ _ _Before you start to use it _ Diclogesic Gel should not be applied on open wounds (e.g. abrasions, cuts) or on damaged skin (e.g 完全なドキュメントを読む
(Diclofenac Diethylamine) PHARMACODYNAMICS: DICLOGESIC® gel is an anti-inflammatory and analgesic preparation for topical application. Its active substance corresponds to 1% diclofenac sodium. The white, creamy, non-greasy preparation is easy to rub into the skin, and its aqueous-alcohol base gives it a soothing and cooling effect. Diclofenac has been shown in experiment to inhibit prostaglandin biosynthesis and this is regarded as an important factor in its mechanism of action. In inflammation of traumatic origin, DICLOGESIC® gel has been shown to relieve pain, reduce oedema, and shorten the time to return of normal function. PHARMACOKINETICS: ABSORPTION: The amount of diclofenac absorbed through the skin is proportional to the contact time and skin area covered with DICLOGESIC® gel, and depends on the total topical dose and on skin hydration. About 6 % of the active substance is absorbed after topical application of 2.5 g diclofenac gel per 500 cm2, as determined by reference to total renal elimination compared with diclofenac tablets. Absorption of diclofenac increases threefold if an occlusive dressing is applied for 10 hours. DISTRIBUTION: Diclofenac can be detected in the plasma, synovial tissue, and synovial fluid after topical application of diclofenac gel to the wrists and knees. Peak plasma concentration of diclofenac gel are about 100 times lower after topical application of diclofenac gel than after oral administration of diclofenac tablets. 99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). METABOLISM: Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single or multiple hydroxylation resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac. ELIMINATION: Total systemic clearance of diclofenac from the plasma is 263 ± 56 ml/min (mean value ± standard deviation). The terminal pla 完全なドキュメントを読む