Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOPROFEN
AETOS PHARMA SDN BHD
KETOPROFEN
7 Pieces
SINIL PHARMACEUTICAL CO., LTD
AETOS KETOTECH 30MG PLASTER _ _ Ketoprofen (30mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Aetos Ketotech 30mg Plaster is used for 2. How Aetos Ketotech 30mg Plaster works 3. Before you use Aetos Ketotech 30mg Plaster 4. How to use Aetos Ketotech 30mg Plaster 5. While you are using it 6. Side effects 7. Storage and Disposal of Aetos Ketotech 30mg Plaster 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. RiMUP serial number WHAT AETOS KETOTECH 30MG PLASTER IS USED FOR Aetos Ketotech 30mg Plaster is used for For relief of the signs and symptoms of the following: Swollen and painful joints Stiff shoulders and shoulder pain Inflammation of tendons Muscular pain Pain, swelling resulting from trauma HOW AETOS KETOTECH 30MG PLASTER WORKS Aetos Ketotech 30mg Plaster contain active substance ketoprofen which belongs to a group of medicines called Nonsteroidal anti-inflammatory drug (NSAIDs). Ketoprofen has pain relieving and fever reducing properties with unique and rapid absorption rate through skin BEFORE YOU USE AETOS KETOTECH 30MG PLASTER - _When you must not use it _ _ _ Do not take this medicinal product if you have the following conditions: Known hypersensitivity to ketoprofen or any component of this formulation. Have or had aspirin or other nonsteroidal anti- inflammatory drug induced asthma or other allergic- type reactions. This product. History of any photosensitivity reaction. Pathological skin changes such as dermatosis, eczema or acne, infected skin lesions, or open wounds. _Pregnancy and lactation _ If you are pregnant, trying to become pregnant or breastfeeding, ask your pharmacist or doctor for advice before using Aetos Ketotech 30mg Plaster. Aetos Ketotech 30mg Plaster use during the first and second trimester of pregnancy should be avoided. Aetos Ketotech 30mg Plaster is contraindicated during the last trimester of pregnancy. _ _ - _Before you start use it _ Tell your doctor or p Baca dokumen lengkap
COMPOSITION Each plaster contains: Ketoprofen .......................................................... 30 mg PHARMACODYNAMICS Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use. ATC code: M02AA10. _MECHANISM OF ACTION_ Ketoprofen is an inhibitor of both the cyclo-oxygenase and lipoxygenase pathways. In addition, ketoprofen is a powerful inhibitor of bradykinin (a chemical mediator of pain and inflammation). _PHARMACODYNAMIC EFFECTS_ Inhibition of prostaglandin synthesis provides for potent anti-inflammatory, analgesic and antipyretic effects. Lipoxygenase inhibitors appear to attenuate cell-mediated inflammation and thus retard the progression of tissue destruction in inflamed joints. Ketoprofen stabilises the lysosomal membranes against osmotic damage and prevents the release of lysosomal enzymes that mediate tissue destruction in inflammatory reactions. RECOMMENDED DOSAGE Adult: Apply one plaster to the affected area after removal of release paper twice daily. ROUTE OF ADMINISTRATION Topical PHARMACOKINETICS By cutaneous route, absorption is very low. The percutaneous application of 50-150 mg of ketoprofen produces plasma levels of the active ingredient of 0.08- 0.15 μg/mL approx. 5-8 hours after application. The systemic passage of the plaster compared to that of the oral formulations of ketoprofen is around 5 per cent, which enables a local effect to be obtained without systemic incidence. 1. Patients with hypersensitivity to this medicine or any of its components. 2. History of any photosensitivity reaction. 3. Patients who have or had Aspirin-induced asthma or asthma attack caused by other non- steroidal anti-inflammatory drugs (NSAID). 4. Patients with hypersensitivity to the following drugs: tiaprofenic acid, fenofibrate, bezafibrate, ciprofibrate, oxybenzone. They may cause cross-hypersensitivity with ketoprofen. 5. Sun exposure, even in the case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation. 6. Third Baca dokumen lengkap