Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
nimesulide
Polipharm Co.
M02AA26
nimesulide
20mg/g
gel
aluminium tube 30g
Prescription
Registered
2019-03-25
NIDOL ® GEL 2% SUMMARY OF PRODUCT CHARACTERISTICS (NIMESULIDE 2G/100 MG) 1. NAME OF THE MEDICINAL PRODUCT Nidol ® Gel 2%, nimesulide 2g /100 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nidol Gel 2% contains 2% w/w nimesulide (1 g of gel contains 20 mg of nimesulide). For excipients, see section 6.1 3. PHARMACEUTICAL FORM Gel. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic relief of pain associated with sprains and acute traumatic tendinitis. 4.2. POSOLOGY AND ADMINISTRATION: Adults Nimesulide 2% gel (usually 3 g, corresponding to a line 6-7 cm long) should be applied in a thin layer to the affected area 2-3 times daily and massaged until it is completely absorbed. Duration of treatment: 7-15 days. Children under 12 years Nimesulide 2% gel has not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children (see section 4.3). 4.3. CONTRAINDICATIONS: Known hypersensitivity to nimesulide or to any of the excipients in the gel. Use in patients in whom aspirin, or other medical products inhibiting prostaglandin synthesis, induced allergic reactions such as rhinitis, urticaria or bronchospasm. Use on broken or denuded skin or in the presence of local infection. Simultaneous use with other topical creams. Use in children under 12 years. Patients with gastro-intestinal bleeding, active or suspected peptic ulcer, severe renal or hepatic dysfunction, severe coagulation disorders or severe/non controlled heart failure should be treated with caution. Severe renal and hepatic impairment (creatinine clearance < 30 ml/min). 4.4. PRECAUTIONS AND WARNINGS: Nimesulide 2% gel should not be applied to skin wounds or open injuries. Nimesulide 2% gel should not be allowed to come into contact with the eyes or mucous membranes; in case of accidental contact, wash immediately with water. The product should never be taken by mouth. Hands should be washed after applying the product. Nimesulide 2% gel should not be used with occlusive dressings. Nim Baca dokumen lengkap