THEO ER TABLET (EXTENDED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

THEOPHYLLINE

Sẵn có từ:

AA PHARMA INC

Mã ATC:

R03DA04

INN (Tên quốc tế):

THEOPHYLLINE

Liều dùng:

400MG

Dạng dược phẩm:

TABLET (EXTENDED-RELEASE)

Thành phần:

THEOPHYLLINE 400MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

RESPIRATORY SMOOTH MUSCLE RELAXANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0103582009; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2010-12-10

Đặc tính sản phẩm

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