RATIO-SALBUTAMOL SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

SALBUTAMOL (SALBUTAMOL SULFATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

R03AC02

INN (International Adı):

SALBUTAMOL

Doz:

5MG

Farmasötik formu:

SOLUTION

Kompozisyon:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Uygulama yolu:

INHALATION

Paketteki üniteler:

10ML

Reçete türü:

Prescription

Terapötik alanı:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Ürün özeti:

Active ingredient group (AIG) number: 0108887006; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2018-05-18

Ürün özellikleri

Teva Canada Limited.
1/33
PRODUCT MONOGRAPH
RATIO-SALBUTAMOL
salbutamol sulphate respirator solution
5 mg/mL
Bronchodilator
(beta
2
-adrenergic agonist)
Teva Canada Limited.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Control: 182939
DATE OF REVISION:
March 19, 2015
Teva Canada Limited.
2/33
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
............................................................................................................
8
DOSAGE AND ADMINISTRATION
......................................................................................
10
OVERDOSAGE
.........................................................................................................................
11
ACTION AND CLINICAL
PHARMACOLOGY.....................................................................
12
STORAGE AND STABILITY
..................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 14
PART II: SCIENTIFIC INFORMATION
....................................................................................
15
PHARMACEUTICAL INFORMATION
..................................................................................
15
CLINICAL TRIALS
................................................................