Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
PIROXICAM
PFIZER PRIVATE LIMITED
M02AA07
0.50%
GEL
TOPICAL
Pharmacy Only
PT PFIZER INDONESIA
1988-06-02
Pfizer Confidential 1 PFIZER FELDENE* PIROXICAM GEL For external use only 1. TRADE NAME(S) OF THE MEDICINAL PRODUCT FELDENE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: anhydrous piroxicam 3. PHARMACEUTICAL FORM Gel: 0.5% (5 mg per gram of gel) by weight anhydrous piroxicam 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piroxicam topical is indicated for a variety of conditions characterized by pain, and inflammation such as osteoarthritis (arthrosis, degenerative joint disease), post traumatic or acute musculoskeletal disorders including tendinitis, tenosynovitis, periarthritis, sprains, strains and low back pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This product is intended for external use only. A 1 gram dose of the 0.5% gel (corresponding to 5 mg of piroxicam) should be applied to the affected site three or four times per day. After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. No occlusive dressing should be employed. Rub in the gel, leaving no residual material on the skin. _USE IN CHILDREN -_ Dosage recommendations and indications for use in children have not been established. Pfizer Confidential 2 4.3 CONTRAINDICATIONS 1. Piroxicam topical should not be used in those patients who have previously shown a hypersensitivity to the gel or piroxicam in any of its dosage forms. The potential exists for cross sensitivity to aspirin and other Non Steroidal Anti-Inflammatory Drugs (NSAIDs). 2. Piroxicam topical Les hele dokumentet