MEROPENEM FOR INJECTION USP POWDER FOR SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
22-10-2019
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Aktiv bestanddel:
MEROPENEM (MEROPENEM TRIHYDRATE)
Tilgængelig fra:
STERIMAX INC
ATC-kode:
J01DH02
INN (International Name):
MEROPENEM
Dosering:
500MG
Lægemiddelform:
POWDER FOR SOLUTION
Sammensætning:
MEROPENEM (MEROPENEM TRIHYDRATE) 500MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
10 VIALS
Recept type:
Prescription
Terapeutisk område:
CARBAPENEMS
Produkt oversigt:
Active ingredient group (AIG) number: 0128599001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2015-02-17
Produktets egenskaber
PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
500 mg/vial and 1 g/vial
(as meropenem trihydrate)
USP
For intravenous use
Antibiotic
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario L6H 6R4
Date of Preparation:
October 22, 2019
Submission Control No: 213538
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_MEROPENEM FOR INJECTION _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................. 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................
5
ADVERSE REACTIONS
.......................................................................................................
9
DRUG
INTERACTIONS......................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................
12
OVERDOSAGE
....................................................................................................................
16
ACTIONS AND CLINICAL PHARMACOLOGY
.............................................................. 16
STORAGE AND STABILITY
.............................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 23
PART II:SCIENTIFIC INFORMATION
.........................................................................
24
PHARMACEUTICAL INFORMATION
.............................................................................
24
CLINICAL
TRIALS………………………………………………………………………..25
DETAILED PHARMACOLOGY
...................................
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