CEFAZOLIN FOR INJECTION USP POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CEFAZOLIN (CEFAZOLIN SODIUM)

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

J01DB04

INN (International Nazwa):

CEFAZOLIN

Dawkowanie:

500MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

CEFAZOLIN (CEFAZOLIN SODIUM) 500MG

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

FIRST GENERATION CEPHALOSPORINS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0109442002; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2019-06-28

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
CEFAZOLIN FOR INJECTION USP
(IM/IV Use)
500 mg, 1 g and 10 g cefazolin per vial
(incorporated as cefazolin sodium)
Sterile Powder for Solution
Antibiotic
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of revision:
November 09, 2018
_ _
_Manufactured by:_
PFIZER HEALTHCARE INDIA PVT. LTD.
Irungattukottai - 602 105, India
_Distributed by: _
APOTEX INC.
150 Signet Drive
Toronto, ON, M9L 1T9
Control No. 220675
_Product Monograph – _
_Pr_
_Cefazolin for Injection USP _
_ _
_Page 2 of 24 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
4
WARNINGS AND PRECAUTIONS
4
ADVERSE REACTIONS
6
DRUG INTERACTIONS
6
DOSAGE AND ADMINISTRATION
6
OVERDOSAGE
11
ACTION AND CLINICAL PHARMACOLOGY
11
STORAGE AND STABILITY
12
SPECIAL HANDLING INSTRUCTIONS
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
13
PART II: SCIENTIFIC INFORMATION
14
PHARMACEUTICAL INFORMATION
14
CLINICAL TRIALS
14
MICROBIOLOGY
15
TOXICOLOGY
16
REFERENCES
18
PART III: PATIENT MEDICATION INFORMATION
21
_Product Monograph – _
_Pr_
_Cefazolin for Injection USP _
_ _
_Page 3 of 24 _
PR
CEFAZOLIN FOR INJECTION USP
(IM/IV Use)
500 mg, 1 g and 10 g cefazolin per vial
(incorporated as cefazolin sodium)
Sterile Powder for Solution
Antibiotic
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM / STRENGTH
CLINICALLY RELEVANT
NONMEDICINAL
INGREDIENTS
Parenteral
(I.V/ I.M)
Powder for injection
500 mg, 1 g and 10 g
cefazolin per vial
The formulation does not contain
any nonmedicinal ingredients
INDICATIONS AND CLINICAL USE
Cefazolin for Injection USP is indicated in the treatment of the
following infections when
caused by susceptible strains of the listed organisms:
RESPIRATORY
TRACT
INFECTIONS
caused
by
_Streptococcus _
_pneumoniae_
,
_Klebsiella_
_pneumoniae_
,
_Haemophilus _
_influenzae_
,
_Staphylococcus _
_aureus_
(penicillin-sensitive
and
penicillin-resistant) and group
_A beta-haemoly