IBUPROFEN ORAL SUSPENSION USP
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
06-01-2021
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
IBUPROFEN
Inapatikana kutoka:
APOTEX INC
ATC kanuni:
M01AE01
INN (Jina la Kimataifa):
IBUPROFEN
Kipimo:
100MG
Dawa fomu:
SUSPENSION
Tungo:
IBUPROFEN 100MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
OTC
Eneo la matibabu:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0108883005; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2007-08-22
Tabia za bidhaa
Page 1 of 30
PRODUCT MONOGRAPH
IBUPROFEN ORAL SUSPENSION
USP
100 MG/5 ML
ANALGESIC, ANTIPYRETIC AGENT – FOR CHILDREN
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
JANUARY 6, 2021
SUBMISSION CONTROL NO. 246862
Page 2 of 30
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND
PRECAUTIONS........................................................................................
3
ADVERSE
REACTIONS.........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
9
DOSAGE AND ADMINISTRATION
.....................................................................................
10
OVERDOSAGE.....................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
12
STORAGE AND STABILITY
................................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
14
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................... 14
PART II: SCIENTIFIC INFORMATION
...................................................................................
15
PHARMACEUTICAL INFORMATION
.................................................................................
15
CLINICAL TRIALS
.............................
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