MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

MEROPENEM (MEROPENEM TRIHYDRATE)

Disponibbli minn:

JAMP PHARMA CORPORATION

Kodiċi ATC:

J01DH02

INN (Isem Internazzjonali):

MEROPENEM

Dożaġġ:

1G

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

MEROPENEM (MEROPENEM TRIHYDRATE) 1G

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0128599002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2023-03-21

Karatteristiċi tal-prodott

_ Meropenem for Injection Product Monograph Page 1 of 38 _
PRODUCT MONOGRAPH
PR MEROPENEM FOR INJECTION
500 mg / vial and 1 g / vial
Meropenem (as meropenem trihydrate)
Manufacturer’s Standard
For Intravenous Use
ANTIBIOTIC
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Preparation:
March 20, 2023
Submission Control No.: 261951
_ Meropenem for Injection Product Monograph Page 2 of 38 _
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
.................................................................................................8
DRUG
INTERACTIONS
...............................................................................................11
DOSAGE
AND
ADMINISTRATION.............................................................................12
OVERDOSAGE
............................................................................................................15
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................16
STABILITY
AND
STORAGE
RECOMMENDATIONS.................................................23
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..............................................23
PART II: SCIENTIFIC
INFORMATION..................................................................................24
PHARMACEUTICAL
INFORMATION
........................................................................24
CLINICAL
TRIALS..................................................................................................