MERREM Poudre pour solution

Țară: Canada

Limbă: franceză

Sursă: Health Canada

Ingredient activ:

Méropénem

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

J01DH02

INN (nume internaţional):

MEROPENEM

Dozare:

1G

Forma farmaceutică:

Poudre pour solution

Compoziție:

Méropénem 1G

Calea de administrare:

Intraveineuse

Unități în pachet:

30ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CARBAPENEMS

Rezumat produs:

Numéro de groupe d'ingrédients actifs (GIA) :0128599002; AHFS:

Statutul autorizaţiei:

COMMERCIALISÉ

Data de autorizare:

2001-07-16

Caracteristicilor produsului

Page 1 of 41
PRODUCT MONOGRAPH
MERREM

Meropenem for injection, 500 mg, 1 g per vial
(as meropenem trihydrate)
For intravenous use
Antibiotic
Pfizer Canada ULC
17 300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: April 8, 2019
Submission Control No: 222507
® Pfizer Ireland Pharmaceuticals
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC 2019
Page 2 of 41
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
...........................................................................
13
OVERDOSAGE
.............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 17
STORAGE AND
STABILITY.......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 26
PART II: SCIENTIFIC INFORMATION
............................................................................
27
PHARMACEUTICAL INFORMATION
......................................................................
27
CLINICAL TRIALS
.......................................................................................................
27
DETAILED PHARMACOLOGY
..........