VENTOLIN I.M. INJECTION 0.5MG SALBUTAMOL IN 1 ML (500MCG/ML) SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostopno od:

GLAXOSMITHKLINE INC

Koda artikla:

R03CC02

INN (mednarodno ime):

SALBUTAMOL

Odmerek:

0.5MG

Farmacevtska oblika:

SOLUTION

Sestava:

SALBUTAMOL (SALBUTAMOL SULFATE) 0.5MG

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

1ML

Tip zastaranja:

Prescription

Terapevtsko območje:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0108887009; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2007-04-19

Lastnosti izdelka

_DCTM/120/633/2006-11-15/131-pm-pristine-ventolin.doc _
_Page 1 of 24_
PRODUCT MONOGRAPH
PR
VENTOLIN
® I.M. INJECTION
salbutamol sulphate for injection
500 mcg/mL
PR
VENTOLIN
® I.V. INFUSION SOLUTION
salbutamol sulphate for injection
1000 mcg/mL
BP
Bronchodilator
(beta
2
-adrenergic stimulant)
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
November 16, 2006
Submission Control No: 107767
_©_
_ 2006 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_VENTOLIN is a registered trademark, used under license by
GlaxoSmithKline Inc. _
_DCTM/120/633/2006-11-15/131-pm-pristine-ventolin.doc _
_Page 2 of 24_
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
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND
STABILITY..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................12
PHARMACEUTICAL
INFORMATION...............................................................