TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Disponibil de la:

SUN PHARMA CANADA INC

Codul ATC:

J01DH51

INN (nume internaţional):

IMIPENEM AND CILASTATIN

Dozare:

250MG; 250MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

30ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CARBAPENEMS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-01-19

Caracteristicilor produsului

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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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_Pr_
_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.