FLUDARABINE PHOSPHATE INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

FLUDARABINE PHOSPHATE

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

L01BB05

INN（国際名）:

FLUDARABINE

投薬量:

25MG

医薬品形態:

SOLUTION

構図:

FLUDARABINE PHOSPHATE 25MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

2ML

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0123842003; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2022-02-28

製品の特徴

PRODUCT MONOGRAPH
Pr
FLUDARABINE PHOSPHATE INJECTION
Mylan Standard
(Fludarabine Phosphate)
25 mg/mL
(2 mL per vial)
Antineoplastic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
June 24, 2014
Submission Control No: 174683
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_Page 2 of 51_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..................................................................................................