MYLAN-IPRATROPIUM SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

IPRATROPIUM BROMIDE

Beszerezhető a:

MYLAN PHARMACEUTICALS ULC

ATC-kód:

R03BB01

INN (nemzetközi neve):

IPRATROPIUM BROMIDE

Adagolás:

250MCG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

IPRATROPIUM BROMIDE 250MCG

Az alkalmazás módja:

INHALATION

db csomag:

20ML

Recept típusa:

Prescription

Terápiás terület:

ANTIMUSCARINICS ANTISPASMODICS

Termék összefoglaló:

Active ingredient group (AIG) number: 0115643001; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2018-07-12

Termékjellemzők

PAGE 1 OF 34
PRODUCT MONOGRAPH
PR
MYLAN-IPRATROPIUM STERINEBS
AND
PR
MYLAN-IPRATROPIUM SOLUTION
(Ipratropium Bromide Inhalation Solution)
0.025% (250
μ
g/mL)
BRONCHODILATOR
Mylan Pharmaceuticals ULC
37 Advance Road
Etobicoke, Ontario
DATE OF REVISION:
Canada M8Z 2S6
December 15, 2010
Control number: 142044
PAGE 2 OF 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY
PRODUCT
INFORMATION................................................................................
3
INDICATIONS
AND
CLINICAL
USES
...................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS...........................................................................................................
6
DRUG
INTERACTIONS
...........................................................................................................
9
DOSAGE
AND
ADMINISTRATION
.......................................................................................
9
OVERDOSAGE
.......................................................................................................................
10
ACTION
AND
CLINICAL
PHARMACOLOGY....................................................................
11
STORAGE
AND
STABILITY
.................................................................................................
14
SPECIAL
HANDLING
INSTRUCTIONS...............................................................................
14
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
16
PHARMACEUTICAL
INFORMATION...........................................................