MELPHALAN FOR INJECTION KIT

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MELPHALAN (MELPHALAN HYDROCHLORIDE)

Tersedia dari:

EUGIA PHARMA INC.

Kode ATC:

L01AA03

INN (Nama Internasional):

MELPHALAN

Dosis:

50MG

Bentuk farmasi:

KIT

Komposisi:

MELPHALAN (MELPHALAN HYDROCHLORIDE) 50MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-04-21

Karakteristik produk

Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MELPHALAN FOR INJECTION
MELPHALAN (AS MELPHALAN HYDROCHLORIDE)
Sterile Lyophilized Powder for Injection (with sterile Diluent)
50 mg / vial
Intravenous Perfusion
House Standard
Antineoplastic (Alkylating) Agent
ATC Code: L01AA03
EUGIA PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation:
APR 21, 2023
Submission Control No: 273284
Page 2 of 22
TABLE OF CONTENTS
PART I: HEALTH PROFESSION
AL INFORMATION…………………………………..
3
1
INDICATIONS……………………………………………………….……………….…..
.3
1.1
Pediatrics………………………………………………………………….…….3
1.2
Geriatrics…………………………………………………………………….….3
2
CONTRAINDICATIONS………………………………..……………………………….3
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX………………………………...
..3
4
DOSAGE AND
ANDMINISTRATION…………………………………………...……..4
4.1.
Dosing
Considerations……………………………………………………………...….4
4.2.
Recommended Dose and Dosage
Adjustment………………………………………....4
4.3.
Administration……………………………………………………………………...….4
4.4.
Reconstitution…………………………………………………………………...……..5
4.5.
Missed
Dose………………………………………………………………….….……..5
5.
OVERDOSAGE……………………………..…………………………………………….6
6.
DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING……..……..6
7.
WARNING
S AND
PRECAUTIONS…………………………..………………………...6
7.1.
Special
Populations………………………………………..…….……………………..9
7.1.1.
Pregnant