OCTOSTIM SPRAY

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DESMOPRESSIN ACETATE

Sẵn có từ:

FERRING INC

Mã ATC:

H01BA02

INN (Tên quốc tế):

DESMOPRESSIN

Liều dùng:

150MCG

Dạng dược phẩm:

SPRAY

Thành phần:

DESMOPRESSIN ACETATE 150MCG

Tuyến hành chính:

NASAL

Các đơn vị trong gói:

2.5ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PITUITARY

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0112050007; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2020-07-17

Đặc tính sản phẩm

_ _
_Octostim_
_®_
_ Injection and Nasal Spray _
_Page 1 of 29 _
PRODUCT MONOGRAPH
OCTOSTIM
®
Desmopressin Acetate
Injection (15 µg/mL)
Nasal Spray (1.5 mg/mL)
(Each metered dose delivers 150 µg/spray)
USP
Antihemorrhagic
Ferring Inc.
200 Yorkland Blvd., Suite 500
North York, Ontario
M2J 5C1
Date of Revision:
April 12, 2018
Submission Control No: 212397
_ _
_Octostim_
_®_
_Injection_
_ _
_and Nasal Spray _
_Page 2 of 29 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
......................................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................................
5
ADVERSE REACTIONS
.......................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................
10
DOSAGE AND ADMINISTRATION
.................................................................................
11
OVERDOSAGE
...................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 12
STORAGE AND STABILITY
.............................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMAT