MERREM Poudre pour solution

Valsts: Kanāda

Valoda: franču

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

Méropénem

Pieejams no:

PFIZER CANADA ULC

ATĶ kods:

J01DH02

SNN (starptautisko nepatentēto nosaukumu):

MEROPENEM

Deva:

1G

Zāļu forma:

Poudre pour solution

Kompozīcija:

Méropénem 1G

Ievadīšanas:

Intraveineuse

Vienības iepakojumā:

30ML

Receptes veids:

Prescription

Ārstniecības joma:

CARBAPENEMS

Produktu pārskats:

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

Autorizācija statuss:

COMMERCIALISÉ

Autorizācija datums:

2001-07-16

Produkta apraksts

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
..........