ATROPINE SULFATE INJECTION USP SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ATROPINE SULFATE

Sẵn có từ:

PFIZER CANADA ULC

Mã ATC:

A03BA01

INN (Tên quốc tế):

ATROPINE

Liều dùng:

1MG

Dạng dược phẩm:

SOLUTION

Thành phần:

ATROPINE SULFATE 1MG

Tuyến hành chính:

INTRAMUSCULAR

Các đơn vị trong gói:

10ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTIMUSCARINICS ANTISPASMODICS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0104748003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-06-12

Đặc tính sản phẩm

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_ATROPINE SULFATE INJECTION USP (atropine sulfate) Product Monograph _
_Page 1 of 14_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATROPINE SULFATE INJECTION USP
Atropine Sulfate
Solution, 0.1 mg/mL for injection
USP
Anticholinergic
Pfizer Canada ULC
17300 Trans Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
December 31, 1975
Date of Revision:
October 26, 2022
Submission Control Number: 264652
_ _
_ _
_ _
_ATROPINE SULFATE INJECTION USP (atropine sulfate) Product Monograph _
_Page 2 of 14_
RECENT MAJOR LABEL CHANGES
No major label changes related to safety and efficacy have been made
within the past 24 months
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
...............................................