TARO-IMIPENEM-CILASTATIN POWDER FOR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Disponible des:

SUN PHARMA CANADA INC

Codi ATC:

J01DH51

Designació comuna internacional (DCI):

IMIPENEM AND CILASTATIN

Dosis:

250MG; 250MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

30ML

tipo de receta:

Prescription

Área terapéutica:

CARBAPENEMS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2021-01-19

Fitxa tècnica

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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.