TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Disponible depuis:

SUN PHARMA CANADA INC

Code ATC:

J01DH51

DCI (Dénomination commune internationale):

IMIPENEM AND CILASTATIN

Dosage:

500MG; 500MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

30ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CARBAPENEMS

Descriptif du produit:

Active ingredient group (AIG) number: 0218820001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-01-19

Résumé des caractéristiques du produit

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_TARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP)
Page 1 of 57 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-IMIPENEM-CILASTATIN
Imipenem and Cilastatin for Injection
250 mg imipenem and 250 mg cilastatin (as cilastatin sodium) per vial
500 mg imipenem and 500 mg cilastatin (as cilastatin sodium) per vial
Sterile powder for solution, I.V. Infusion
USP
ANTIBIOTIC
Sun Pharma Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
MAY 20, 2010
Date of Revision:
JULY 22, 2022
Submission Control Number: 260927
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_TARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP)
Page 2 of 57 _
RECENT MAJOR LABEL CHANGES
4. DOSAGE AND ADMINISTRATION
07/2022
7. WARNINGS AND PRECAUTIONS
01/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES.............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS........................................................................................................................
4
1.1 PEDIATRICS
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5
1.2 GERIATRICS
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5
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX......................................................................
5
4 DOSAGE AND ADMINISTRATION
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6
4.