THEO ER TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

THEOPHYLLINE

Saatavilla:

AA PHARMA INC

ATC-koodi:

R03DA04

INN (Kansainvälinen yleisnimi):

THEOPHYLLINE

Annos:

600MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

THEOPHYLLINE 600MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

RESPIRATORY SMOOTH MUSCLE RELAXANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0103582010; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2010-12-10

Valmisteyhteenveto

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