SANDOZ CEFTRIAXONE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 1G

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0117292003; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2018-08-01

Summary of Product characteristics

_ _
PRODUCT MONOGRAPH
SANDOZ CEFTRIAXONE
Sterile Ceftriaxone for Injection BP
1 G AND 2 G CEFTRIAXONE PER VIAL (INCORPORATED AS CEFTRIAXONE SODIUM)
ANTIBIOTIC
Sandoz Canada Inc.
Date of Revision: January 15, 2010
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
CONTROL # : 133307
_Sandoz Ceftriaxone _
_ Page 2 of 51_
_ _
TABLE OF CONTENTS
HEALTH PROFESSIONAL
INFORMATION.........................................................................
3
ACTION
.....................................................................................................................................
3
INDICATIONS AND CLINICAL
USES...................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS...............................................................................................................................
4
PRECAUTIONS.........................................................................................................................
6
ADVERSE
REACTIONS...........................................................................................................
8
SYMPTOMS AND TREATMENT OF OVERDOSAGE
....................................................... 10
DOSAGE AND
ADMINISTRATION.....................................................................................
10
ADMINISTRATION................................................................................................................
11
PHARMACEUTICAL
INFORMATION.................................................................................
13
DRUG
SUBSTANCE...............................................................................................................
13
DRUG
PRODUCT....................................................................................................................
13
RECONSTITUTION
.......................................................................................