IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM); IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM)

Pieejams no:

VITA HEALTH PRODUCTS INC

ATĶ kods:

M01AE51

SNN (starptautisko nepatentēto nosaukumu):

IBUPROFEN, COMBINATIONS

Deva:

25MG; 200MG; 200MG

Zāļu forma:

CAPSULE

Kompozīcija:

DIPHENHYDRAMINE HYDROCHLORIDE 25MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG; IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM) 200MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

DAYTIME 12/24 - NIGHTTIME 6/12

Receptes veids:

OTC

Ārstniecības joma:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0354570001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2015-02-16

Produkta apraksts

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_Page 1 of 61_
PRODUCT MONOGRAPH
IBUPROFEN DAYTIME,
IBUPROFEN NIGHTTIME
(DAY/NIGHT CONVENIENCE PACK)
IBUPROFEN DAYTIME
Ibuprofen Liquid Capsules 200 mg
(free acid and potassium salt)
Analgesic
IBUPROFEN NIGHTTIME
Ibuprofen and Diphenhydramine Hydrochloride Liquid Gel Capsules
Ibuprofen 200 mg (free acid and potassium salt) and Diphenhydramine
Hydrochloride 25 mg
Analgesic/Sleep Aid
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg Manitoba
Canada, R2J 3W2
Submission Control No. 180118
Date of Preparation:
January 30, 2015
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_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 26
STORAGE AND STABILITY
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
CLINICAL TRIALS
..............................