MELPHALAN FOR INJECTION KIT

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

MELPHALAN (MELPHALAN HYDROCHLORIDE)

Disponível em:

JUNO PHARMACEUTICALS CORP.

Código ATC:

L01AA03

DCI (Denominação Comum Internacional):

MELPHALAN

Dosagem:

50MG

Forma farmacêutica:

KIT

Composição:

MELPHALAN (MELPHALAN HYDROCHLORIDE) 50MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Resumo do produto:

Active ingredient group (AIG) number: 0102597002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2022-03-23

Características técnicas

Melphalan for Injection
Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
P
R
MELPHALAN FOR INJECTION
Melphalan (as melphalan hydrochloride)
Sterile Lyophilized
Powder for Solution
(with Diluent)
50 mg / vial
Intravenous Perfusion
Antineoplastic (Alkylating)
Agent
ATC Code: L01AA03
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Initial Authorization:
March 16, 2022
Control Number: 240053
Melphalan for Injection
Page 2 of 22
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................. 4
1
INDICATIONS
.......................................................................................................
4
1.1 Pediatrics:
...........................................................................................................
4
1.2 Geriatrics (> 65 years):.
.......................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................ 5
4
DOSAGE AND
ADMINISTRATION.....................................................................
5
4.1 Dosing
Considerations.........................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
....................................................... 5
4.3 Administration
....................................................................................................
6
4.4 Reconstitution
.....................................................................................................
6
4.5 Missed
Dose........................................................................................................
7
5
OVERDOSAGE
......................................................................................................
7
6
DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING ............. 8
7
WARNINGS AND