IMIPENEM AND CILASTATIN FOR INJECTION, USP POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CILASTATIN (CILASTATIN SODIUM); IMIPENEM

Pieejams no:

STERIMAX INC

ATĶ kods:

J01DH51

SNN (starptautisko nepatentēto nosaukumu):

IMIPENEM AND CILASTATIN

Deva:

250MG; 250MG

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

CILASTATIN (CILASTATIN SODIUM) 250MG; IMIPENEM 250MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

CARBAPENEMS

Produktu pārskats:

Active ingredient group (AIG) number: 0218820002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-03-10

Produkta apraksts

Page 1 of 50
PRODUCT MONOGRAPH
PR
IMIPENEM AND CILASTATIN FOR INJECTION, USP
Imipenem 250 mg and Cilastatin 250 mg (as cilastatin sodium) per vial
Imipenem 500 mg and Cilastatin 500 mg (as cilastatin sodium) per vial
Sterile Powder for Intravenous Infusion
ANTIBIOTIC
SteriMax Inc.
2770 Portland Drive
Oakville, ON
L6H 6R4
Control No.: 271444
Date of Preparation:
MAR 10, 2023
Page 2 of 50
TABLE OF CONTENTS
PRODUCT MONOGRAPH
..........................................................................................................
1
THERAPEUTIC
CLASSIFICATION
...........................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.........................................................................................................
3
CONTRAINDICATIONS
..............................................................................................................................
5
WARNINGS
..................................................................................................................................................
5
PRECAUTIONS
............................................................................................................................................
6
OVERDOSAGE
...........................................................................................................................................
12
DOSAGE
AND
ADMINISTRATION
.........................................................................................................
12
PHARMACEUTICAL
INFORMATION
....................................................................................................
16
COMPATIBILITY
AND
STABILITY
........................................................................................................
17
AVAILABILITY
OF
DOSAGE
FORMS
....................................................................................................
18
STORAGE
..................................................................................