MUSTARGEN POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MECHLORETHAMINE HYDROCHLORIDE

Tersedia dari:

LUNDBECK PHARMACEUTICALS LLC

Kode ATC:

L01AA05

INN (Nama Internasional):

CHLORMETHINE

Dosis:

10MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

MECHLORETHAMINE HYDROCHLORIDE 10MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

10MG VIAL

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2011-11-11

Karakteristik produk

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