Ketoprofen-BP

Lisinat de ketoprofen

1 ml of solution for injection/concentrate for solution for infusion contains ketoprofen 50 mg as ketoprofen lysine salt; each 2 ml ampoule contains ketoprofen 100 mg. Excipient with known effect: benzyl alcohol 20 mg/ml.

Indication: Short-term symptomatic treatment of inflammatory, degenerative and metabolic rheumatic diseases (rheumatoid arthritis, seronegative spondyloarthropathy, gout, osteoarthritis, extra-articular rheumatism), and relief of post-operative pain, low back pain, cancer-related, post-traumatic and musculoskeletal pain.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. − Ketoprofen-BP is contraindicated in patients with a history of hypersensitivity reactions such as bronchospasm, asthma attacks, allergic rhinitis, nasal polyposis, urticaria or other allergic reactions induced by ketoprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Severe, rarely fatal, anaphylactic reactions have been reported in such patients (see section 4.8). − Active peptic ulcer or any history of gastrointestinal bleeding, ulceration or perforation − Haemorrhagic diathesis − Ongoing cerebrovascular, gastrointestinal or other haemorrhage − Severe hepatic impairment − Severe renal impairment − Severe heart failure − Ketoprofen-BP is contraindicated for intramuscular administration in patients with haemostatic disorders or concomitant anticoagulant treatment − Ketoprofen-BP is contraindicated during the third trimester of pregnancy (see section 4.6). − This medicinal product is contraindicated in children and adolescents.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Warnings Concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. - Adverse reactions can be minimised by using the lowest effective dose for the shortest period necessary to control symptoms (see section 4.2 and the cardiovascular and gastrointestinal risks described below). Masking of symptoms of underlying infections Ketoprofen-BP may mask the symptoms of an infection, which may lead to delayed initiation of appropriate treatment and thereby worsen the outcome of the infection. This has been observed in cases of community-acquired bacterial pneumonia and bacterial complications of varicella. When Ketoprofen-BP is administered for fever or pain relief associated with an infection, it is recommended […]