Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
Naratriptan Hydrochloride 2.78 mg eqv Naratriptan
GLAXOSMITHKLINE PTE LTD
N02CC02
2.5 mg
TABLET, FILM COATED
Naratriptan Hydrochloride 2.78 mg eqv Naratriptan 2.5 mg
ORAL
Prescription Only
GlaxoSmithKline Pharmaceuticals S.A.
ACTIVE
1998-07-28
PHARMA CODE REF. NO. 662 1 10000000033419 GSK-AUS-BORONIA-AUBOR SINGAPORE-SGP NARAMIG 1 PROCESS K LFT017 NO BOR ONIA - ADDITIONAL ARTWORK INFORMATION PANEL COMPONENT NAME NARAMIG T ABS 2.5MG LEAFLET SINGAPORE COMPONENT NO. 10000000033419 SITE CHANGE NO. 200291098 SPECIFICATION NO. TLFT010 NOTE TO SUPPLIER: N/A FRONT OF LEAFLET PAGE 1 OF 2 NARAMIG ™ NARATRIPTAN QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 2.5 mg of naratriptan as naratriptan_ _hydrochloride. PHARMACEUTICAL FORM Film coated tablets. CLINICAL PARTICULARS INDICATIONS _NARAMIG_ tablets are indicated for the acute treatment of migraine attacks with or without aura. DOSAGE AND ADMINISTRATION _NARAMIG_ tablets should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage. _NARAMIG_ tablets should not be used prophylactically. _NARAMIG_ tablets should be swallowed whole with water. • ADULTS (18 TO 65 YEARS OF AGE) The recommended dose of _NARAMIG_ tablets is a single 2.5 mg tablet. The total dose should not exceed two 2.5 mg tablets in any 24 h period. If symptoms of migraine should recur, following an initial response, a second dose may be taken provided that there is a minimum interval of 4 h between the two doses. If a patient does not respond to the first dose of _NARAMIG_ tablets it is unlikely that a second dose will be of benefit in the same attack. _NARAMIG_ tablets may be used for subsequent migraine attacks. • ADOLESCENTS (12 TO 17 YEARS OF AGE) In a clinical trial in adolescents, a very high placebo response was observed. The efficacy of _NARAMIG_ in this population has therefore not been demonstrated and its use cannot be recommended. • CHILDREN (UNDER 12 YEARS OF AGE) There are no data available on the use of _NARAMIG_ in children under 12 years of age therefore its use in this age group is not recommended. • ELDERLY (OVER 65 YEARS OF AGE) Th Đọc toàn bộ tài liệu
NARAMIG™ NARATRIPTAN_ _ QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing 2.5 mg of naratriptan as naratriptan _ _ hydrochloride. PHARMACEUTICAL FORM Film coated tablets. CLINICAL PARTICULARS INDICATIONS _NARAMIG_ tablets are indicated for the acute treatment of migraine attacks with or without aura. DOSAGE AND ADMINISTRATION _NARAMIG_ tablets should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage. _NARAMIG_ tablets should not be used prophylactically. _NARAMIG_ tablets should be swallowed whole with water. • ADULTS (18 TO 65 YEARS OF AGE) The recommended dose of _NARAMIG_ tablets is a single 2.5 mg tablet. The total dose should not exceed two 2.5 mg tablets in any 24 hour period. If symptoms of migraine should recur, following an initial response, a second dose may be taken provided that there is a minimum interval of four hours between the two doses. If a patient does not respond to the first dose of _NARAMIG_ tablets it is unlikely that a second dose will be of benefit in the same attack. _NARAMIG_ tablets may be used for subsequent migraine attacks. • ADOLESCENTS (12 TO 17 YEARS OF AGE) In a clinical trial in adolescents, a very high placebo response was observed. The efficacy of _NARAMIG_ in this population has therefore not been demonstrated and its use cannot be recommended. • CHILDREN (UNDER 12 YEARS OF AGE) There are no data available on the use of _NARAMIG_ in children under 12 years of age therefore its use in this age group is not recommended. • ELDERLY (OVER 65 YEARS OF AGE) The safety and effectiveness of _NARAMIG_ in individuals over age 65 have not been evaluated. There is a moderate decrease in clearance with age ( _see Pharmacokinetics_ ). • RENAL IMPAIRMENT The maximum total daily dose in patients with renal impairment is a single 2.5 mg tablet. The use of _NARAMIG_ is contraindicated in patients with severe renal impairment (creatinine clearance less than 15 ml/min) ( _see Contraindications and Pharmaco Đọc toàn bộ tài liệu