MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MEROPENEM (MEROPENEM TRIHYDRATE)

Disponibil de la:

JAMP PHARMA CORPORATION

Codul ATC:

J01DH02

INN (nume internaţional):

MEROPENEM

Dozare:

500MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

MEROPENEM (MEROPENEM TRIHYDRATE) 500MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2023-03-21

Caracteristicilor produsului

_ 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..................................................................................................