S.O.S. NALOXONE HYDROCHLORIDE INJECTION SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

NALOXONE HYDROCHLORIDE

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

V03AB15

INN (Tên quốc tế):

NALOXONE

Liều dùng:

0.4MG

Dạng dược phẩm:

SOLUTION

Thành phần:

NALOXONE HYDROCHLORIDE 0.4MG

Tuyến hành chính:

INTRAMUSCULAR

Các đơn vị trong gói:

1ML/2ML

Loại thuốc theo toa:

Ethical

Khu trị liệu:

OPIATE ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0108981002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-03-22

Đặc tính sản phẩm

_S.O.S. Naloxone Hydrochloride Injection _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
S.O.S. NALOXONE HYDROCHLORIDE INJECTION
Naloxone Hydrochloride
0.4 mg/mL and 1.0 mg/mL solution for injection
USP
Opioid Antagonist
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Québec, Canada
J4B 7K8
Date of Revision:
April 26, 2017
Submission Control No: 203781
_ _
_S.O.S. Naloxone Hydrochloride Injection _
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................8
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................8
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL INFORMATION
..........................................................................10
DETAILED PHARMACOLOGY
.....................................................................................10
TOXICOLOGY
.......................................................