IBUPROFEN + PSEUDOEPHEDRINE CAPLETS TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
25-08-2016
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:
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Fáanlegur frá:
MARCAN PHARMACEUTICALS INC
ATC númer:
M01AE51
INN (Alþjóðlegt nafn):
IBUPROFEN, COMBINATIONS
Skammtar:
200MG; 30MG
Lyfjaform:
TABLET
Samsetning:
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
10/24/100
Gerð lyfseðils:
OTC
Lækningarsvæði:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0222394001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2016-08-23
Vara einkenni
Page 1 of 47
PRODUCT MONOGRAPH
IBUPROFEN + PSEUDOEPHEDRINE CAPLETS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
Caplets
Analgesic/Antipyretic/Nasal Decongestant
Marcan Pharmaceuticals Inc.
Date of Preparation:
77 Auriga Drive, Unit #4
August 23, 2016
Ottawa, Ontario
K2E 7Z7
Control# 197421
Page 2 of 47
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................................
5
ADVERSE REACTIONS
....................................................................................................................
10
DRUG INTERACTIONS
.....................................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................................
20
OVERDOSAGE
...................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
22
STORAGE AND STABILITY
............................................................................................................
26
SPECIAL HANDLING INSTRUCTION
............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................................
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