PAIN RELIEVER & SLEEP AID TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
30-09-2020
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:
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Fáanlegur frá:
APOTEX INC
ATC númer:
M01AE57
INN (Alþjóðlegt nafn):
NAPROXEN AND DIPHENHYDRAMINE
Skammtar:
25MG; 220MG
Lyfjaform:
TABLET
Samsetning:
DIPHENHYDRAMINE HYDROCHLORIDE 25MG; NAPROXEN SODIUM 220MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
OTC
Lækningarsvæði:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0257270001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2020-10-08
Vara einkenni
Page 1 of 47
PRODUCT MONOGRAPH
PAIN RELIEVER & SLEEP AID
Naproxen Sodium 220 mg and Diphenhydramine Hydrochloride 25mg Tablets
Apotex Inc.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Preparation:
September 30, 2020
Control No. 230683
Page 2 of 47
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
3
WARNINGS AND PRECAUTIONS
...........................................................................................................
4
ADVERSE REACTIONS
.............................................................................................................................
7
DRUG INTERACTIONS
...........................................................................................................................
12
DOSAGE AND ADMINISTRATION
.......................................................................................................
14
OVERDOSAGE...........................................................................................................................................
15
ACTION AND CLINICAL
PHARMACOLOGY......................................................................................
15
STORAGE AND STABILITY
...................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
18
PART II: SCIENTIFIC INFORMATION
.............................................................................................
20
PHARMACEUTICAL INFORMATION
........
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