MELPHALAN FOR INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MELPHALAN (MELPHALAN HYDROCHLORIDE); BUFFER SOLUTION

متاح من:

APOTEX INC

ATC رمز:

L01AA03

INN (الاسم الدولي):

MELPHALAN

جرعة:

50MG; 10ML

الشكل الصيدلاني:

SOLUTION

تركيب:

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

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

10ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANTINEOPLASTIC AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2017-10-13

خصائص المنتج

_Melphalan for Injection Product Monograph Page 1 of 27 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MELPHALAN FOR INJECTION
Melphalan (as hydrochloride) Injection
Sterile Lyophilized Powder for Solution for Injection, 50 mg / vial,
Intravenous and intra-arterial
use
Antineoplastic (Alkylating) Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
OCT 13, 2017
Date of Revision:
JUN 09, 2023
Submission Control Number: 271053
_Melphalan for Injection Product Monograph Page 2 of 27 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose
Adjustment
06/2023
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.................................................................4
4
DOSAGE AND ADMINISTRATION
.....................................................................................5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................