Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
meloxicam
Boehringer Ingelheim Espana S.A.
M01AC06
meloxicam
15mg/1,5ml
solution for i/m injection
(3) ampoules 1,5ml
Prescription
Registered
2017-11-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Movalis 15 mg / 1.5 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 10 mg meloxicam. One ampoule with 1.5 ml solution contains 15 mg meloxicam in the form of the enolate salt which is formed in situ during the manufacturing process. Excipient(s) with known effect Contains less than 1 mmol sodium (23mg) per 1.5 ml ampoule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A yellow solution with a greenish tinge. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Short-term symptomatic treatment of acute exacerbations of rheumatoid arthritis and ankylosing spondylitis, when other routes of administration are not appropriate. - Movalis solution for injection is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One 15 mg injection once a day. DO NOT EXCEED THE DOSE OF 15 mg/day. The treatment should normally be limited to a single injection for treatment initiation with a maximum extension to 2 to 3 days in substantiated exceptional cases (i.e. when other routes are not possible). Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically. Special populations _Elderly patients (see section 5.2) _ The recommended dose in elderly patients is 7.5 mg per day (half an 1.5 ml ampoule) (see also sections 4.2 ‘Patients with increased risks for adverse reaction’ and 4.4). 1 2 _Patients with increased risks for adverse reaction (see section 4.4) _ In patients with increased risks for adverse reactions, e.g. a history of gastro -intestinal disease or risk factors for cardiovascular disease, the treatment should be started at a dose of 7.5 mg per day (half a 1.5 ml ampoule). _Renal impairment (see section 5.2) _ This medicine is contraindicated in non-dia Прочитать полный документ