MEROPENEM FOR INJECTION USP POWDER FOR SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MEROPENEM (MEROPENEM TRIHYDRATE)

Saatavilla:

STERIMAX INC

ATC-koodi:

J01DH02

INN (Kansainvälinen yleisnimi):

MEROPENEM

Annos:

500MG

Lääkemuoto:

POWDER FOR SOLUTION

Koostumus:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

10 VIALS

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CARBAPENEMS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0128599001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2015-02-17

Valmisteyhteenveto

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
...................................