TEVA-TERIPARATIDE INJECTION SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TERIPARATIDE (TERIPARATIDE ACETATE)

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

H05AA02

INN (Tên quốc tế):

TERIPARATIDE

Liều dùng:

250MCG

Dạng dược phẩm:

SOLUTION

Thành phần:

TERIPARATIDE (TERIPARATIDE ACETATE) 250MCG

Tuyến hành chính:

SUBCUTANEOUS

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PARATHYROID AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0150152001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-08-06

Đặc tính sản phẩm

_Teva-Teriparatide Injection _
_Page 1 of 61_
PRODUCT MONOGRAPH
PR
TEVA-TERIPARATIDE INJECTION
Sterile Solution for Subcutaneous Injection
250 mcg / mL teriparatide (as teriparatide acetate)
Teva Standard
Bone Formation Agent
Teva Canada Limited
30 Novopharm Court
Toronto, ON M1B 2K9
Date of Revision:
April 17, 2023
Submission Control No: 269436
_Teva-Teriparatide _
_Page 2 of 61 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................18
INSTRUCTIONS FOR PEN USE
.....................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
.............................................................