Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLURBIPROFEN
RB (HEALTH) MALAYSIA SDN BHD
FLURBIPROFEN
15 ml
Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited
_Consumer Medication Information Leaflet (RiMUP) _ STREPSILS MAX PRO DIRECT 8.75MG SPRAY Flurbiprofen (8.7480mg/0.540ml) _____________________________________________________________________________________________ _____________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET: 1. What Strepsils Max Pro Direct 8.75mg Spray is used for 2. How Strepsils Max Pro Direct 8.75mg Spray works 3. Before you use Strepsils Max Pro Direct 8.75mg Spray 4. How to use Strepsils Max Pro Direct 8.75mg Spray 5. While you are using it 6. Side effects 7. Storage and Disposal of Strepsils Max Pro Direct 8.75mg Spray 8. Product Description 9. Manufacturer and Product Registration Holder. 10. Date of revision 11. Serial Number WHAT STREPSILS MAX PRO DIRECT 8.75MG SPRAY IS USED FOR Strepsils Max Pro Direct 8.75mg Spray is indicated for the short term symptomatic relief of acute sore throat in adults. HOW STREPSILS MAX PRO DIRECT 8.75MG SPRAY WORKS The active ingredient (which makes the medicine work) is flurbiprofen. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines provide relief by changing how the body responds to pain and high temperature. BEFORE YOU USE STREPSILS MAX PRO DIRECT 8.75MG SPRAY _-When you must not use it: _ Do not take Strepsils Max Pro Direct 8.75mg Spray if you - If you are allergic to flurbiprofen or to any of the excipients - have had a previous allergic reaction after taking Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or aspirin (acetylsalicylic acid); e.g. asthma, wheezing, itching, runny nose, skin rashes, swelling - If you have (or have had two or more episodes of) a stomach ulcer or bleeding of the stomach - If you have a history of gastro- intestinal bleeding or perforation related to previous NSAID therapy - During the last three months of pregnancy - If you have severe liver, kidney or heart failure - Or give to children and adolescents below 18 years. _Pregnancy and lactation _ Do not take t Preberite celoten dokument
STREPSILS MAX PRO DIRECT SPRAY Flurbiprofen 8.75mg Product Description : Oromucosal spray, solution. Clear, colourless to slightly yellow solution. The active ingredient is flurbiprofen. The other ingredients are: Betadex, Disodium phosphate dodecahydra te, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium hydroxide, Mint flavour, Cherry flavour, N,2,3 -Trimethyl -2-isopropylbutanamide, Saccharin sodium, Hydroxypropyl betadex and Purified water. Pharmacod ynamics Flurbiprofen is a propionic acid derivative NSAID w hich acts through inhibition of prostaglandin synthesis. In humans flurbiprofen has potent analgesic, a ntipyretic and anti -inflammatory properties and the 8.75 mg dose dissolved in arti ficial saliv a has been shown to reduce prostaglandin synthesis in cultured human respiratory cells. According to studies using the whole blood assay, flurbiprofen is a mixed COX -1/COX -2 inhibitor with some selectivity towards COX -1. Pre -clinical studies suggest that t he R ( -) enantiomer of flur biprofen and related NSAIDs may act on the central nervous system; the suggested mechanism is by inhibition of induced COX -2 at the level of the spinal cord. A single dose of flurbiprofen 8.75 mg delivered locally to the throat a s three sprays has been demonstrated to relieve sore throat, including swollen and inflamed sore throats through a significant change in the severity of throat soreness a rea under the change (AUC) from baseline curve (mean difference (standard deviation)) for active treatment ver sus placebo from 0 to 2 hours ( -1.82 (1.35) vs -1.13 (1.14)), 0 to 3 hours ( -2.01 (1.405) vs -1.31 (1.233)) and 0 to 6 hours ( -2.14 (1.551) vs -1.50 (1.385). Signific ant differences in the AUC from baseline curve from 0 – 6 hours co mpared to placebo were also s een for other qualities of sore throat including pain intensity ( - 22.50 (17.894) vs -15.64 ( 16.413)), difficulty swallowing (-22.50 (18.260) vs -16.01 (15.451)), swollen throat ( - 20.97 ( 18.897) vs Preberite celoten dokument