Država: Armenija
Jezik: angleščina
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lornoxicam
Takeda Austria GmbH
M01AC05
lornoxicam
8mg
powder lyophilized for solution for i/v and i/m injection
(5) glass vial
Prescription
Registered
2022-03-23
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xefocam liofilizate for solution for intravenous and intramuscular injection 8mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains: _Active substance_: lornoxicam 8.0 mg*. *Amount of lornoxicam, including an excess of 7.5%, is 8.6 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Liofilizate for solution for intravenous and intramuscular injection. APPEARANCE Yellow dense mass. Reconstituted solution - yellow clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of mild or moderate acute pain syndrome. Symptomatic therapy of pain and inflammation in patients with osteoarthritis. Symptomatic therapy of pain and inflammation in patients with rheumatoid arthritis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For parenteral administration. The solution for injection should be prepared immediately before the use by dissolving the contents of one vial (8 mg of lornoxicam) with water for injection (2 ml). When the solution is prepared, the needle should be replaced. Intramuscular injections should be administered with the use of a long needle. The prepared solution should be administered intravenously or intramuscularly in patients with postoperative pain and intramuscularly in patients with acute attack of lumbago/sciatica. The duration of intravenous administration of the solution should be not less than 15 seconds, intramuscular - not less than 5 seconds. The recommended single dose: 8 mg intravenously or intramuscularly. The daily dose should not exceed 16 mg. Some patients may require an additional dose of 8 mg during the first 24 hours. The lowest effective dose should be used within the minimum possible short course. Additional information for specific patient groups _Children and adolescents_ Lornoxicam is not intended for use in children and adolescents under 18 years of age, as data on its safety and efficacy are not sufficient. _Elderly patients_ No special dose adj Preberite celoten dokument