NOVO-AZITHROMYCIN PEDIATRIC POWDER FOR SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

זמין מ:

TEVA CANADA LIMITED

קוד ATC:

J01FA10

INN (שם בינלאומי):

AZITHROMYCIN

כמות:

200MG

טופס פרצבטיות:

POWDER FOR SUSPENSION

הרכב:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 200MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15/22.5ML

סוג מרשם:

Prescription

איזור תרפויטי:

OTHER MACROLIDES

leaflet_short:

Active ingredient group (AIG) number: 0126072003; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2016-11-28

מאפייני מוצר

PRODUCT MONOGRAPH
PR
NOVO-AZITHROMYCIN
Azithromycin Tablets 250 mg
Azithromycin (as Azithromycin monohydrate hemiethanolate)
PR
NOVO-AZITHROMYCIN PEDIATRIC
Azithromycin Powder for Oral Suspension
100 mg*/5 mL and 200 mg*/ 5mL
*
Azithromycin (as Azithromycin monohydrate hemiethanolate)
ANTIBIOTIC
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No: 198791
Date of Revision:
October 07, 2016
_Novo-Azithromycin Product Monograph _
_ _
_Page 2 _
_ _
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
..............................................................................................
10
DRUG
INTERACTIONS...............................................................................................
16
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 25
STORAGE AND
STABILITY.......................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
.............................................................................
30
PHARMACEUTICAL INFORMATION
.......................................................................
30
CLINICAL TRIALS
.........................................