Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
ELETRIPTAN HYDROBROMIDE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N02CC06
FILM COATED TABLETS
ELETRIPTAN HYDROBROMIDE 96.97 MG
PER OS
Required
R - PHARM GERMANY GMBH
ELETRIPTAN
ELETRIPTAN
Acute treatment of the headache phase of migraine attacks, with or without aura.
2011-12-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת 04.06.2015 םש רישכת תילגנאב רפסמו םושירה םש רישכת תילגנאב רפסמו םושירה / 01 124.28.30370.00 RELERT 20MG RELERT 40MG 124.29.30371.00 /01 RELERT 80MG 124.30.30372.00 /01 םש לעב םושירה : רזייפ יא ףא יפ מ"עב הקיטבצמרפ ! דבלב תורמחהה טורפ תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח SPECIAL WARNINGS AND PRECAUTIONS FOR USE N/A Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5 HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5 HT1 agonists have not been clearly established. UNDESIRABLE EFFECTS In post-marketing experience, the following additional undesirable effects have been reported: … Nervous System Disorders: Rare cases of syncope. In post-marketing experience, the following additional undesirable effects have been reported: … Nervous System Disorders: Serotonin syndrome, rare cases of syncope, cerebrovascular accident. Přečtěte si celý dokument
Relert Tablets, 02 June 2015 2014-0005401, 2014-0005377, 2015-0011107, 2015-0010225 RELERT TABLETS 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20mg, 40mg and 80mg eletriptan (as hydrobromide). Excipients with known effect: Each film-coated tablet of Relert 20 mg contains 23 mg lactose monohydrate and Sunset yellow. Each film-coated tablet of Relert 40 mg contains 46 mg lactose monohydrate and Sunset yellow. Each film-coated tablet of Relert 80 mg contains 92 mg lactose monohydrate and Sunset yellow. For the full list of excipients, see section 6.1. 2. PHARMACEUTICAL FORM Film-coated tablet. Round, convex orange tablets debossed with ‘REP 20’, ‘REP 40’ and ‘REP 80’on one side and ‘Pfizer’ on the other. 3. CLINICAL PARTICULARS 3.1 THERAPEUTIC INDICATIONS Acute treatment of the headache phase of migraine attacks, with or without aura. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION PosologyRELERT tablets should be taken as early as possible after the onset of migraine headache but they are also effective if taken at a later stage during a migraine attack. RELERT, if taken during the aura phase, has not been demonstrated to prevent migraine headache and therefore RELERT should only be taken during the headache phase of migraine. _ _ RELERT tablets should not be used prophylactically _. _ _ _ The tablets should be swallowed whole with water _._ ADULTS (18-65 YEARS OF AGE): The recommended initial dose is 40 mg. _If headache returns within 24 hours_ : If the migraine headache recurs within 24 hours of an initial response, a second dose of the same strength of RELERT has been shown to be effective in treating the recurrence. If a second dose is required, it should not be taken within 2 hours of the initial dose. _If no response is obtained:_ If a patient does not achieve a headache response to the first dose of RELERT within 2 hours, a second dose should not be taken for the same attack as clinical trials have not adequately established efficacy with the second dose. Clinical t Přečtěte si celý dokument