PHL-SALBUTAMOL RESPIRATOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SALBUTAMOL (SALBUTAMOL SULFATE)

Sẵn có từ:

PHARMEL INC

Mã ATC:

R03AC02

INN (Tên quốc tế):

SALBUTAMOL

Liều dùng:

5MG

Dạng dược phẩm:

SOLUTION

Thành phần:

SALBUTAMOL (SALBUTAMOL SULFATE) 5MG

Tuyến hành chính:

INHALATION

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0108887006; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2017-09-13

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PHL-SALBUTAMOL RESPIRATOR SOLUTION
Salbutamol Sulphate Inhalation Solution
0.05%; 0.1%; 0.2%; 0.5%
0.5 mg/mL; 1 mg/mL; 2 mg/mL; 5 mg/mL
BRONCHODILATOR
Beta
2
-adrenergic stimulant
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
October 07, 2016
Submission Control No: 198569
_ _
_phl-SALBUTAMOL RESPIRATOR SOLUTION Product Monograph Page 2 of 36_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
................................................................................
9
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
...................................................................