TEVA-IPRATROPIUM STERINEBS SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IPRATROPIUM BROMIDE

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

R03BB01

INN (nume internaţional):

IPRATROPIUM BROMIDE

Dozare:

250MCG

Forma farmaceutică:

SOLUTION

Compoziție:

IPRATROPIUM BROMIDE 250MCG

Calea de administrare:

INHALATION

Unități în pachet:

1ML/2ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIMUSCARINICS ANTISPASMODICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

1996-04-01

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-IPRATROPIUM STERINEBS
Ipratropium bromide inhalation solution
Solution for inhalation, 250 mcg/mL (0.025%), for oral inhalation use
Bronchodilator (Anticholinergic)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 253021
Date of Initial Authorization:
Mar 04, 1998
Date of Revision:
Feb. 01, 2022
2
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................................
3
1
INDICATIONS
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3
_1.1_
_Pediatrics:
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3_
_1.2_
_Geriatrics:
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3_
2
CONTRAINDICATIONS
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3
4
DOSAGE
AND
ADMINISTRATION
.............................................................................................................
3
_4.1 Dosing Considerations
.........................................................................................................................
3_
_4.2 Recommended Dose and Dosage Adjustment
.....................................................................................
4_
_4.4 Administration
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