APO-CEFPROZIL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

J01DC10

INN (Διεθνής Όνομα):

CEFPROZIL

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SECOND GENERATION CEPHALOSPORINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0127613002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2007-03-09

Αρχείο Π.Χ.Π.

Page 1 of 27
PRODUCT MONOGRAPH
PR
APO-CEFPROZIL
Cefprozil Tablets
(cefprozil as cefprozil monohydrate)
250 mg and 500 mg cefprozil (on anhydrous basis)
USP
Antibiotic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
DATE OF REVISION:
M9L 1T9
June 3, 2020
_Control Number: _235587
_ _
Page 2 of 27
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
.........................................................................................................
8
DOSAGE AND ADMINISTRATION
.....................................................................................
8
OVERDOSAGE
........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 9
STORAGE AND STABILITY
...............................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 11
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL INFORMATION
...............................................................................
12
CLINICAL TRIALS
...............................................................................................................
13
MIC