PRIMAXIN 500 POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Disponible depuis:

MERCK 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:

25 VIALS (100 OR 250 ML)

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CARBAPENEMS

Descriptif du produit:

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

Statut de autorisation:

MARKETED

Date de l'autorisation:

2006-12-13

Résumé des caractéristiques du produit

_ _
_PRIMAXIN_
_®_
_ (imipenem and cilastatin sodium for injection, USP) _
_Page 1 of 61 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PRIMAXIN®
imipenem and cilastatin for injection, USP
500 mg imipenem and 500 mg cilastatin (as cilastatin sodium) per vial
Sterile powder for solution, I.V. Infusion
ANTIBIOTIC
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
JUL 07,1987
Date of Revision:
DEC 21, 2021
Submission Control Number: 253551
_ _
_PRIMAXIN_
_®_
_ (imipenem and cilastatin sodium for injection, USP) _
_Page 2 of 61 _
RECENT MAJOR LABEL CHANGES
4. DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
12/2021
4. DOSAGE AND ADMINISTRATION
06/2020
7. WARNINGS AND PRECAUTIONS
06/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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[To update, right-click anywhere in the Table of Contents and select
“Update Field”, “Update entire
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RECENT MAJOR LABEL CHANGES
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TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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1.1 Pediatrics
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1.2 Geriatrics
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CONTRAINDICATIONS
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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