NAT-OSELTAMIVIR POWDER FOR SUSPENSION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Disponibbli minn:

NATCO PHARMA (CANADA) INC

Kodiċi ATC:

J05AH02

INN (Isem Internazzjonali):

OSELTAMIVIR

Dożaġġ:

6MG

Għamla farmaċewtika:

POWDER FOR SUSPENSION

Kompożizzjoni:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 6MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

NEURAMINIDASE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0139501005; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2020-06-05

Karatteristiċi tal-prodott

_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
NAT-OSELTAMIVIR
oseltamivir capsules
oseltamivir phosphate capsules, USP
30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate)
oseltamivir powder for oral suspension
6 mg/mL oseltamivir (as oseltamivir phosphate) when reconstituted
Antiviral Agent
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Revision:
September 18, 2020
Submission Control No: 223389
_Page 2 of 50 _
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
.................................................................................................
7
DRUG INTERACTIONS
...............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
14
OVERDOSAGE
.............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 22
STORAGE AND STABILITY
.......................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 21
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
.......................................................................
23
CLINICAL TRIALS
..........................................