IMIPENEM AND CILASTATIN FOR INJECTION, USP POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

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Download Vara einkenni (SPC)
10-03-2023

Virkt innihaldsefni:

CILASTATIN (CILASTATIN SODIUM); IMIPENEM

Fáanlegur frá:

STERIMAX INC

ATC númer:

J01DH51

INN (Alþjóðlegt nafn):

IMIPENEM AND CILASTATIN

Skammtar:

250MG; 250MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

CILASTATIN (CILASTATIN SODIUM) 250MG; IMIPENEM 250MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

CARBAPENEMS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-03-10

Vara einkenni

                                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
..................................................................................
                                
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