NOVO-AZITHROMYCIN PEDIATRIC POWDER FOR SUSPENSION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

J01FA10

INN (Tarptautinis Pavadinimas):

AZITHROMYCIN

Dozė:

200MG

Vaisto forma:

POWDER FOR SUSPENSION

Sudėtis:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 200MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

15/22.5ML

Recepto tipas:

Prescription

Gydymo sritis:

OTHER MACROLIDES

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2016-11-28

Prekės savybės

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
.........................................