UNITUXIN SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DINUTUXIMAB

제공처:

UNITED THERAPEUTICS CORPORATION

ATC 코드:

L01FX06

INN (국제 이름):

DINUTUXIMAB BETA

복용량:

3.5MG

약제 형태:

SOLUTION

구성:

DINUTUXIMAB 3.5MG

관리 경로:

INTRAVENOUS

패키지 단위:

5ML

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0160890001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2018-11-28

제품 특성 요약

_Unituxin Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
UNITUXIN
®
Dinutuximab for injection
3.5 mg/mL Injection for Intravenous Use
Antineoplastic
United Therapeutics Corp.
Research Triangle Park, NC
27709, USA
Imported By:
Unither Biotech Inc.
Magog, QC, J1X 2B4
Date of Initial Approval:
November 28, 2018
Submission Control No: 212066
_Unituxin Product Monograph _
_Page 2 of 32_
TABLE OF CONTENTS
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1.
INDICATIONS
...................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
DOSING CONSIDERATIONS
......................................................................................
4
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
............................................... 5
4.2.1
RECOMMENDED DOSE
.........................................................................................
5
4.2.2
REQUIRED PRE-TREATMENT AND GUIDELINES FOR PAIN MANAGEMENT AND
INFUSION REACTIONS
.............................................................................................
5
4.2.2.1
REQUIRED PRE-TREATMENT AND GUIDELINES FOR PAIN MANAGEMENT AND
INFUSION REACTIONS DURING ALL UNITUXIN-ADMINISTERED COURSES
................. 5
4.2.2.2
REQUIRED PRETREATMENT AND GUIDELINES FOR PAIN MANAGEMENT AND
INFUSION REACTION WHEN IL-2 IS ADMINISTERED ALONE (COURSE 2 AND 4,
COURSE DAYS 0-3)
..............................................................................