TARO-MEROPENEM POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MEROPENEM (MEROPENEM TRIHYDRATE)

Disponibil de la:

SUN PHARMA CANADA INC

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:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CARBAPENEMS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-12-22

Caracteristicilor produsului

_Pr_
_TARO-MEROPENEM (Meropenem For Injection USP, 500 mg, 1 g per vial)
Product Monograph _
Page 1 of 36
PRODUCT MONOGRAPH
PR
TARO-MEROPENEM
Meropenem For Injection USP, 500 mg, 1 g per vial
(as meropenem trihydrate)
For intravenous use
Antibiotic
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
December 18, 2020
Submission Control No: 243010
_Pr_
_TARO-MEROPENEM (Meropenem For Injection USP, 500 mg, 1 g per vial)
Product Monograph _
Page 2 of 36
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
.......................................................................................
11
OVERDOSAGE
.........................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
15
STORAGE AND STABILITY
..................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 22
PART II: SCIENTIFIC INFORMATION
......................................................................................
23
PHAR