CEFTRIAXONE SODIUM FOR INJECTION POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

J01DD04

INN (Διεθνής Όνομα):

CEFTRIAXONE

Δοσολογία:

1G

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 1G

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

4ML(REGULAR)/2.8ML(LOW VOLUME)

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

THIRD GENERATION CEPHALOSPORINS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2006-11-02

Αρχείο Π.Χ.Π.

_PAGE 1 OF 58 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CEFTRIAXONE SODIUM FOR INJECTION
(STERILE CEFTRIAXONE SODIUM) STERILE POWDER FOR SOLUTION, 1 G AND 10 G CEFTRIAXONE PER VIAL,
INTRAVENOUS OR INTRAMUSCULAR
BP
ANTIBIOTIC
TEVA CANADA LIMITED
30 NOVOPHARM COURT
TORONTO, ONTARIO
M1B 2K9
CONTROL NO: 246728
DATE OF INITIAL
AUTHORIZATION:
NOV. 02, 2006
DATE OF REVISION:
MAY 26, 2021
_PAGE 2 OF 58 _
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS 04/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
Table of Contents
RECENT MAJOR LABEL CHANGES
.....................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1.
INDICATIONS...............................................................................................................
4
1.1
PEDIATRICS.....................................................................................................................
5
1.2 GERIATRICS
.....................................................................................................................
5
2.
CONTRAINDICATIONS
................................................................................................
5
4.
DOSAGE AND ADMINISTRATION
...............................................................................
5
4.1 DOSING CONSIDERATIONS
................................................................................................
5
4.2 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT............................................................
5
4.3 RECONSTITUTION
..............................................................................................................
7
4.4
ADMINISTRATION..................................................................................