CETROTIDE POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CETRORELIX (CETRORELIX ACETATE)

Sẵn có từ:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Mã ATC:

H01CC02

INN (Tên quốc tế):

CETRORELIX

Liều dùng:

0.25MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

CETRORELIX (CETRORELIX ACETATE) 0.25MG

Tuyến hành chính:

SUBCUTANEOUS

Các đơn vị trong gói:

1ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

GONADOTROPIN-RELEASING HORMONE ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0149341001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2003-08-13

Đặc tính sản phẩm

_ _
_Cetrotide® (cetrorelix acetate) _
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_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CETROTIDE
®
Cetrorelix for Injection
0.25 mg cetrorelix (as cetrorelix acetate)
Powder for Solution, Subcutaneous
GnRH antagonist
EMD Serono, A Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga, Ontario L5K 2N6
A Business of Merck KGaA, Darmstadt, Germany
Date of Revision:
June 13, 2019
Submission Control No: 221823
®
Registered trademark of Zentaris IVF GmbH
_ _
_Cetrotide® (cetrorelix acetate) _
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_Page 2 of 26_
TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................3
1
INDICATIONS
....................................................................................................................3
2
CONTRAINDICATIONS ..................................................................................................3
3
DOSAGE AND ADMINISTRATION ...............................................................................3
3.1
Recommended Dose and Dosage Adjustment
...........................................................3
3.2
Administration
...........................................................................................................4
3.3
Reconstitution
............................................................................................................4
3.4
Missed Dose
...............................................................................................................4
4
OVERDOSAGE .................................................................................................................4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................5
5.1
Composition
...............................................................................................................5
5.2
Dosage Forms and Packaging
..................