AA-THEO LA 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:

200MG

Dạng dược phẩm:

TABLET (EXTENDED-RELEASE)

Thành phần:

THEOPHYLLINE 200MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100 TABLETS

Loại thuốc theo toa:

Prescription

Khu trị liệu:

RESPIRATORY SMOOTH MUSCLE RELAXANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0103582003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-04-30

Đặc tính sản phẩm

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_AA-THEO LA _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-THEO
LA
Theophylline Anhydrous
Sustained-Release Tablets, 100, 200, 300 mg and Oral
House Standard
Bronchodilator
ATC Code: R03DA04
AA PHARMA INC.
1165 Creditstone Road, Unit#1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
DEC 31, 1993
Date of Revision:
January 13, 2022
Submission Control Number: 254884
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_AA-THEO LA _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
1 Indications
12/2021
3 Serious Warnings and Precautions Box
12/2021
7 Warnings and Precautions
12/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.....................................................................................................5
5
OVERDOSAGE
.................................