SANDOZ SALBUTAMOL SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

SALBUTAMOL (SALBUTAMOL SULFATE)

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

R03AC02

INN (nume internaţional):

SALBUTAMOL

Dozare:

5MG

Forma farmaceutică:

SOLUTION

Compoziție:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Calea de administrare:

INHALATION

Unități în pachet:

10ML(5MG/ML)

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2017-05-25

Caracteristicilor produsului

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PRODUCT MONOGRAPH
PR
SANDOZ SALBUTAMOL
(salbutamol sulfate inhalation solution)
0.5%
5 mg/mL
BRONCHODILATOR
Beta
2
-adrenergic stimulant
SANDOZ CANADA INC.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision:
May 17, 2017
Submission Control No: 205188
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
................................................................................
9
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 13
PART II: SCIENTIFIC INFORMATION
...............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
..........................................................................................................
15
DETAILED PHARMACOLOGY
...........