TEVA-ZOLMITRIPTAN OD TABLET (ORALLY DISINTEGRATING)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
06-04-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ZOLMITRIPTAN
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
N02CC03
INN (Alþjóðlegt nafn):
ZOLMITRIPTAN
Skammtar:
2.5MG
Lyfjaform:
TABLET (ORALLY DISINTEGRATING)
Samsetning:
ZOLMITRIPTAN 2.5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
2/6
Gerð lyfseðils:
Prescription
Lækningarsvæði:
SELECTIVE SEROTONIN AGONISTS
Vörulýsing:
Active ingredient group (AIG) number: 0134381001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2011-06-07
Vara einkenni
PRODUCT MONOGRAPH
PR
TEVA-ZOLMITRIPTAN
(zolmitriptan) tablets
2.5 mg
PR
TEVA-ZOLMITRIPTAN OD
(zolmitriptan) orally disintegrating tablets
2.5 mg
Teva Standard
Migraine Therapy
5-HT
1
Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 237687
Date of Revision:
April 6, 2020
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
19
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 21
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
...........................................
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