CEFAZOLIN SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CEFAZOLIN (CEFAZOLIN SODIUM)

Διαθέσιμο από:

STERIMAX INC

Φαρμακολογική κατηγορία (ATC):

J01DB04

INN (Διεθνής Όνομα):

CEFAZOLIN

Δοσολογία:

10G

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

CEFAZOLIN (CEFAZOLIN SODIUM) 10G

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

FIRST GENERATION CEPHALOSPORINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0109442006; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2022-02-11

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFAZOLIN SODIUM FOR INJECTION BP
Powder for Solution, 1 gram, 2 grams and 10 grams Cefazolin (as
cefazolin sodium) per vial
Intravenous, Intramuscular
BP
Antibiotic
SteriMax Inc.
Date of Initial Authorization: JUN 24, 2020
2770 Portland Drive
Oakville, ON
Date of Revision: SEP 14, 2022
L6H 6R4
Control No: 263261
Pr
CEFAZOLIN SODIUM FOR INJECTION BP Page 2 of 21
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, SKIN
01/2021
7 WARNINGS AND PRECAUTIONS, RENAL
09/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage Adjustment
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4.3
Reconstitution
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7
4.4
Administration
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