VENTOLIN DISKUS POWDER

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SALBUTAMOL (SALBUTAMOL SULFATE)

Tersedia dari:

GLAXOSMITHKLINE INC

Kode ATC:

R03AC02

INN (Nama Internasional):

SALBUTAMOL

Dosis:

200MCG

Bentuk farmasi:

POWDER

Komposisi:

SALBUTAMOL (SALBUTAMOL SULFATE) 200MCG

Rute administrasi :

INHALATION

Unit dalam paket:

60 DOSES

Jenis Resep:

Prescription

Area terapi:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108887005; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2001-07-26

Karakteristik produk

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_Page 1 of 24_
PRODUCT MONOGRAPH
PR
VENTOLIN DISKUS
salbutamol sulfate dry powder for inhalation
200 mcg salbutamol/blister
Bronchodilator
(beta
2
-adrenergic agonist)
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
November 17, 2017
Submission Control No: 207155
© 2017 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK
group of companies.
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_Page 2 of 24_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
..................