Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
LORNOXICAM
Nycomed UK Limited
8 Milligram
Pdr+Solv for soln for Inf
2010-02-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xefo 8mg powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 8 mg lornoxicam. After reconstitution in 2 ml solvent, reconstituted solution contains 4mg/ml of lornoxicam. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: Yellow, solid substance Solvent: Clear, colourless liquid, practically free from particles The osmolarity of the reconstituted solution is about 328 mosmol/kg and pH is about 8.7 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term relief of acute mild to moderate pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This specific application form should only be used if a quick onset of pain relief is needed or if an oral application or an application via suppository is not possible. Generally the treatment should comprise one single injection for therapy initiation only. For all patients the appropriate dosing regimen should be based upon individual response to treatment. Pain Recommended dose: 8 mg intravenous or intramuscular. Daily dose should not exceed 16 mg. Some patients may need a further 8 mg given during the first 24 hours. The route of administration is intravenous (IV) or intramuscular injection (IM). When given as IV injection, the time of injection should be at least 15 seconds, and for IM injection, at least 5 seconds. After preparation of the solution, the needle should be changed. For IM injection a sufficiently long needle for a deep intramuscular injection. For further instructions on handling of the product before administration, see section 6.1. The medicinal product is for single use only Additional information on special populations Chi Przeczytaj cały dokument