Země: Arménie
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tramadol (tramadol hydrochloride)
KRKA d.d.
N02AX02
tramadol (tramadol hydrochloride)
50mg
capsules
(20/2x10/) in blister
Prescription
Registered
2017-04-03
1.3.1
Tramadol
hydrochloride
SPC,
Labeling and Packa
e Leaflet
AM
HHCTPYKU:HH NO ME.UHU:HHCKOMYNPHMEHEHHIO
JIEKAPCTBEHHORO
cpe~cTBa
TPAMA):(OJI
TOPROBOE
HA3BAHHE
TpaMa,nOJI
Me~YHapO)lHOe
HENATEHTOBAHHOE
HA3BAHHE
TpaMa,nOJI
JIEKAPCTBEHHAH
Přečtěte si celý dokument
Summary of Product Characteristics CONFIDENTIAL Tramadol 50 mg capsules MODULE VOL: 1; P: 13 / 47 1.3.1 Tramadol SPC, Labeling and Package Leaflet AM-Armenia PI_Text007697_4 - Updated: Page 1 of 13 1. NAME OF THE MEDICINAL PRODUCT Tramadol 50 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg tramadol hydrochloride. For a list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. Two-coloured capsules: the body of the capsule is white and the cap is blue. The content of capsules: white or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain in adults and adolescents aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total daily dose of 400 mg active substance should not be exceeded, except in special circumstances. Unless otherwise prescribed, Tramadol should be administered as follows: _Adults and adolescents aged 12 years and over_ Dosage form Single dose Total daily dose Tramadol 50-100 mg Every 4 to 6 hours (1 to 2 hard capsules) (see section 5.1) 400 mg (Up to 8 hard capsules) If there is no sufficient pain relief after administration of a single dose of 50 mg tramadol hydrochloride within 30 to 60 minutes, a second single dose of 50 mg can be administered. If in severe pain the demand is likely to be higher, the higher single dose of Tramadol (100 mg tramadol hydrochloride) may be given as the initial dose. ACUTE PAIN: An initial dose of 100 mg is usually necessary. This can be followed by doses of 50 or 100 mg at 4 - 6 hourly intervals, and duration of treatment should be matched to clinical need. PAIN ASSOCIATED WITH CHRONIC CONDITIONS: An initial dose of 50 mg is advised and then titration CONFIDENTIAL Tramadol 50 mg capsules MODULE VOL: 1; P: 14 / 47 1.3.1 Tramadol SPC, Labeling and Package Leaflet AM- Přečtěte si celý dokument