SUVEXX TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
20-12-2021
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE); NAPROXEN SODIUM
Fáanlegur frá:
ARALEZ PHARMACEUTICALS CANADA INC
ATC númer:
N02CC51
INN (Alþjóðlegt nafn):
SUMATRIPTAN AND NAPROXEN
Skammtar:
85MG; 500MG
Lyfjaform:
TABLET
Samsetning:
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 85MG; NAPROXEN SODIUM 500MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0262035001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2020-02-27
Vara einkenni
_SUVEXX_
®
_ Product Monograph _
_(sumatriptan/naproxen sodium) tablets _
_ _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SUVEXX
®
sumatriptan/naproxen sodium tablets
85 mg sumatriptan (as sumatriptan succinate) / 500 mg naproxen sodium
Serotonin (5-HT
1B/1D
) receptor agonist (triptan) / Non-Steroidal Anti-Inflammatory Drug
(NSAID)
Aralez Pharmaceuticals Canada Inc.*
6733 Mississauga Road, Suite 800
Mississauga, Ontario
Canada L5N 6J5
www.miravohealthcare.com
Date of Initial Approval:
February 26, 2020
Date of Revision:
December 20, 2021
Submission Control No: 253456
*Doing business as (d/b/a) Miravo Healthcare
_ _
_SUVEXX_
®
_ Product Monograph _
_(sumatriptan/naproxen sodium) tablets _
_ _
_ _
_Page 2 of 45_
TABLE OF CONTENTS
TABLE OF
CONTENTS.......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 4
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics
..........................................................................................................
4
2
CONTRAINDICATIONS
...........................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................. 6
4
DOSAGE AND ADMINISTRATION
.........................................................................
7
4.1
General
.............................................................................................................
7
4.2
Dosing
Considerations.....................................................................................
7
4.3
Recommended Dose and Dosage Adjustment
.............................................. 7
4.4
Administration...........................
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