VENTOLIN I.V. INFUSION SOLUTION 5.0MG SALBUTAMOL IN 5ML (1000MCG/ML)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostępny od:

GLAXOSMITHKLINE INC

Kod ATC:

R03CC02

INN (International Nazwa):

SALBUTAMOL

Dawkowanie:

1MG

Forma farmaceutyczna:

SOLUTION

Skład:

SALBUTAMOL (SALBUTAMOL SULFATE) 1MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

5 ML DOSE X 5

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108887007; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2001-07-26

Charakterystyka produktu

_2014-07-03/131-pristine-eng-ventolin-IV-infusion-sol.doc _
_ _
_Page 1 of 22_
_ _
_ _
_ _
PRODUCT MONOGRAPH
PR
VENTOLIN
® I.V. INFUSION SOLUTION
salbutamol sulphate for injection
1000 mcg/mL
BP
Bronchodilator
(beta
2
-adrenergic agonist)
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
July 3, 2014
Submission Control No: 173386
_©_
_ 2014 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_VENTOLIN is a registered trademark, used under license by
GlaxoSmithKline Inc. _
_2014-07-03/131-pristine-eng-ventolin-IV-infusion-sol.doc _
_ _
_Page 2 of 22_
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
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTI