MEROPENEM FOR INJECTION POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

MEROPENEM (MEROPENEM TRIHYDRATE)

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

J01DH02

SNN (starptautisko nepatentēto nosaukumu):

MEROPENEM

Deva:

1G

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

MEROPENEM (MEROPENEM TRIHYDRATE) 1G

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

20ML

Receptes veids:

Prescription

Ārstniecības joma:

CARBAPENEMS

Produktu pārskats:

Active ingredient group (AIG) number: 0128599003; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2012-01-26

Produkta apraksts

_ _
_Meropenem for Injection _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
MEROPENEM FOR INJECTION
(meropenem for injection)
500 mg and 1 g vials
USP
For intravenous use
Antibiotic
Sandoz Canada Inc.
Date of Revision: October 6, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission Control No: 239077
_ _
_Meropenem for Injection _
_Page 2 of 38_
TABLE OF CONTENT
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
........................................................ 22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL
INFORMATION
.................................................................................
24
CLINICAL
TRIALS
...................................................................