MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEROPENEM (MEROPENEM TRIHYDRATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01DH02

INN (International Name):

MEROPENEM

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

MEROPENEM (MEROPENEM TRIHYDRATE) 1G

Administration route:

INTRAVENOUS

Units in package:

20ML

Prescription type:

Prescription

Therapeutic area:

CARBAPENEMS

Product summary:

Active ingredient group (AIG) number: 0128599003; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-01-26

Summary of Product characteristics

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_Meropenem for Injection _
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PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
(meropenem for injection)
500 mg and 1 g vials
USP
For intravenous use
Antibiotic
Sandoz Canada Inc.
Date of Revision: October 6, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission Control No: 239077
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_Meropenem for Injection _
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TABLE OF CONTENT
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
...........................................................................................................
8
DRUG
INTERACTIONS
.........................................................................................................
11
DOSAGE
AND
ADMINISTRATION
.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
16
STABILITY AND STORAGE RECOMMENDATIONS
........................................................ 22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL
INFORMATION
.................................................................................
24
CLINICAL
TRIALS
...................................................................