MELPHALAN FOR INJECTION KIT

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MELPHALAN (MELPHALAN HYDROCHLORIDE)

Dostupno od:

AURO PHARMA INC

ATC koda:

L01AA03

INN (International ime):

MELPHALAN

Doziranje:

50MG

Farmaceutski oblik:

KIT

Sastav:

MELPHALAN (MELPHALAN HYDROCHLORIDE) 50MG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2020-11-19

Svojstava lijeka

Page 1 of 21
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
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation:
November 18, 2020
Submission Control No: 222235
Page 2 of 21
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
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.
WARNINGS AND
PRECAUTIONS…………………………..………………………...6
7.1.
Special
Populations………………………………………..…….……………………..9
7.1.1.
Pregnant