Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Sanofi-Aventis Ireland Limited
2.5 %w/w
Gel
2005-11-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oruvail 2.5 % w/w Gel. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The gel contains 2.5% w/w of ketoprofen. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel. A clear, colourless or practically colourless, transparent gel free from visible lumps. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the topical management of soft tissue and for the relief of pain and inflammation associated with extra-articular rheumatism and osteoarthritis in joints. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The route of administration is topical to the affected area. Recommended Dosage: Adults: Application by gentle massage 2 to 4 times daily. Treatment should not extend beyond 6 weeks. Elderly: There are no specific dosage recommendations for the elderly. Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed(_see section 4.4, Special warnings_ _and precautions for use_). Children: Not recommended for children under 12 years of age. Contact with the eyes or mucosa should be avoided. 4.3 CONTRAINDICATIONS o Patients with a history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to ketoprofen, aspirin or non-steroidal anti-inflammatory drugs. o Hypersensitivity to any of the excipients of Oruvail Gel o Use on pathological skin changes such as eczema or acne; or in infectious skin or open wounds o Patients with active peptic ulceration o Use with occlusive dressings o Simultaneous use to the same site with any other topical cream o Use in children under 12 years of age o Third trimester of pregnancy IRISH MEDICI Læs hele dokumentet