ALKERAN SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION

Dostupné s:

ASPEN PHARMACARE CANADA INC.

ATC kód:

L01AA03

INN (Mezinárodní Name):

MELPHALAN

Dávkování:

50MG; 10ML

Léková forma:

SOLUTION

Složení:

MELPHALAN (MELPHALAN HYDROCHLORIDE) 50MG; BUFFER SOLUTION 10ML

Podání:

INTRA-ARTERIAL

Jednotky v balení:

10ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0225962001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2015-01-05

Charakteristika produktu

_ _
_ _
_ALKERAN_
_®_
_ 2 mg and 50 mg/vial melphalan _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALKERAN
®
Melphalan
Tablets, 2 mg, Oral
Powder for solution for injection, 50 mg/vial, for Intravenous and
intra-arterial use
Mfg. Std., BP
Antineoplastic (Alkylating) Agent
Aspen Pharmacare Canada Inc
8 – 1155 North Service Road West
Oakville, ON, L6M 3E3
Date of Initial Authorization:
DEC 31, 1964
Date of Revision:
SEP 23, 2022
Submission Control Number: 261646
Trademarks are owned by or licensed to the Aspen Group of companies.
_ _
_ _
_ALKERAN_
_®_
_ 2 mg and 50 mg/vial melphalan _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and Dose
Adjustment
08/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5