THEO ER TABLET (EXTENDED-RELEASE)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-09-2021
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:
THEOPHYLLINE
Fáanlegur frá:
AA PHARMA INC
ATC númer:
R03DA04
INN (Alþjóðlegt nafn):
THEOPHYLLINE
Skammtar:
400MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
THEOPHYLLINE 400MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
RESPIRATORY SMOOTH MUSCLE RELAXANTS
Vörulýsing:
Active ingredient group (AIG) number: 0103582009; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2010-12-10
Vara einkenni
Page 1 of 31
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN, ONTARIO
L4K 4N7
Date of Revision: September 28, 2021
Submission Control No.: 255971
BRONCODILATOR
PR
THEO ER
Theophylline Sustained-Release
Tablets
Tablets, 400 mg and 600 mg, Oral
House
Standard
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1.
INDICATIONS
.........................................................................................................................
4
1.1.
Pediatrics
.......................................................................................................................
4
1.2.
Geriatrics
.......................................................................................................................
4
2.
CONTRAINDICATIONS
..........................................................................................................
4
4 DOSAGE AND ADMINISTRATION
............................................................................................
4
4.1 Dosing Considerations
........................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
.................................................................. 4
4.5
Missed Dose
....................................................................................................................
5
5
OVERDOSAGE
.......................................................................................................................
6
6.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................. 8
7
WARNINGS AND PRECAUTIO
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