Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
KRKA d.d.
M01AB05
diclofenac (diclofenac sodium)
75mg/3ml
solution for injection
(5) ampoules 3ml
Prescription
Registered
2017-05-11
PI_Text008165_1 – Updated: Page 1 of 12 1. NAME OF THE MEDICINAL PRODUCT Naklofen 75 mg/3 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 3 ml of solution for injection (1 ampoule) contains 75 mg diclofenac sodium. Excipients with known effect: - benzyl alcohol: 120 mg/3 ml solution - sodium: 0.29736 mmol/3 ml solution - sodium metabisulphite: 3 mg/3 ml solution For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution for injection is a clear, colourless to slightly yellow solution, practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diseases in which anti-inflammatory and/or analgesic activity is required: - inflammatory rheumatic diseases: rheumatoid arthritis, spondyloarthritides, chronic idiopathic juvenile arthritis, other arthritides, - degenerative rheumatism of the joints and spine: arthrosis, spondylosis, - crystal-induced arthritides: gout and pseudogout, - extra-articular rheumatism: periarthritis, bursitis, myositis, tendinitis, synovitis, - other inflammatory and painful states of the musculoskeletal system. As an analgesic, Naklofen is used in soft tissue injuries, in various dental procedures, after surgery, in severe migraine attacks, in renal and biliary colics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For the suppression of severe pain, 1 ampoule is administered intramuscularly once to twice daily. As soon as possible, treatment should be continued with other forms of the drug (gastro-resistant tablets, prolonged-release tablets, capsules, suppositories). In renal colics, a second injection may be given 30 minutes after the first one. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control (relieve) symptoms (see section 4.4). _Patients with renal insufficiency_ The drug should be administered with caution to patients with renal insufficiency (see section 4.4). CONFIDENTIAL Naklofen 75 mg/3 ml solution for injection Прочитать полный документ