MUSTARGEN POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MECHLORETHAMINE HYDROCHLORIDE

Sẵn có từ:

LUNDBECK PHARMACEUTICALS LLC

Mã ATC:

L01AA05

INN (Tên quốc tế):

CHLORMETHINE

Liều dùng:

10MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

MECHLORETHAMINE HYDROCHLORIDE 10MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

10MG VIAL

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0152196001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2011-11-11

Đặc tính sản phẩm

PAGE 1 OF 17
PRODUCT MONOGRAPH
TRITURATION OF
MUSTARGEN
®
mechlorethamine HCl for injection USP
Sterile vial for injection containing 10 mg mechlorethamine
hydrochloride
Alkylating Agent
Lundbeck Inc.
Date of Preparation:
Four Parkway North
September 11, 2009
Deerfield, IL 60015, U.S.A
CONTROL # 132246
PAGE 2 OF 17
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
.............................................................................................
6
DRUG INTERACTIONS
..............................................................................................
8
DOSAGE AND
ADMINISTRATION.............................................................................
8
OVERDOSAGE.........................................................................................................
10
PART II: SCIENTIFIC INFORMATION
.........................................................................
10
ACTION AND CLINICAL
PHARMACOLOGY............................................................
10
STORAGE AND STABILITY
.....................................................................................
10
SPECIAL HANDLING
INSTRUCTIONS....................................................................
11
DOSAGE FORMS, COMPOSITION AND
PACKAGING........................................... 11
PHARMACEUTICAL INFORMATION
.......................................................................
11
REFERENCES..........................................................................................................
12
PART III: C