APO-CEFEPIME POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

J01DE01

INN (Διεθνής Όνομα):

CEFEPIME

Δοσολογία:

1G

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

FOURTH GENERATION CEPHALOSPORINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0150504004; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-08-17

Αρχείο Π.Χ.Π.

Page 1 of 40
PRODUCT MONOGRAPH
Pr
APO-CEFEPIME
Cefepime for Injection USP
1 g and 2 g cefepime per vial (as cefepime hydrochloride)
Antibiotic
_ _
APOTEX INC.
DATE OF PREPARATION:
150 Signet Drive,
NOVEMBER 12, 2019
Toronto, Ontario
M9L 1T9
Control Number: 231676 _ _
Page 3 of 40
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
8
DRUG
INTERACTIONS.........................................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................................
11
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
..................................................................................
21
PHARMACEUTICAL INFORMATION
................................................................................
21
CLINICAL TRIA