APO-IPRAVENT STERULES SOLUTION
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
07-03-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
IPRATROPIUM BROMIDE
Fáanlegur frá:
APOTEX INC
ATC númer:
R03BB01
INN (Alþjóðlegt nafn):
IPRATROPIUM BROMIDE
Skammtar:
250MCG
Lyfjaform:
SOLUTION
Samsetning:
IPRATROPIUM BROMIDE 250MCG
Stjórnsýsluleið:
INHALATION
Einingar í pakka:
2ML
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ANTIMUSCARINICS ANTISPASMODICS
Vörulýsing:
Active ingredient group (AIG) number: 0115643001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
1997-06-23
Vara einkenni
Page 1 of 34
PRODUCT
MONOGRAPH
APO-IPRAVENT
LPRATROPIUM BROMIDE NEBULIZER SOLUTION
250 MCG/ML (0.025%) IN 20 ML BOTTLES AND 2 ML STERULES
125 MCG/ML (0.0125%) IN 2 ML STERULES
BRONCHODILATOR
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
FEBRUARY 07, 2017
CONTROL NO:
190543
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND PRECAUTIONS
........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
6
DRUG INTERACTIONS
.......................................................................................................
10
DOSAGE AND ADMINISTRATION
......................................................................................
10
OVERDOSAGE
....................................................................................................................
11
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
....................................................
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