IDARUBICIN HYDROCHLORIDE INJECTION SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

IDARUBICIN HYDROCHLORIDE

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

L01DB06

INN (Medzinárodný Name):

IDARUBICIN

Dávkovanie:

1MG

Forma lieku:

SOLUTION

Zloženie:

IDARUBICIN HYDROCHLORIDE 1MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

5/10/20

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0122755004; AHFS:

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2022-02-28

Súhrn charakteristických

1
PRODUCT MONOGRAPH
PR
IDARUBICIN HYDROCHLORIDE INJECTION
IDARUBICIN HYDROCHLORIDE
PROFESSED
1 MG/ML
[5 ML, 10 ML AND 20 ML VIALS]
Antineoplastic Agent
Sterile Solution
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: February 20, 2020
Submission Control No.: 234642
2
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
...............................................................................................................
9
DRUG
INTERACTIONS
.............................................................................................................
10
DOSAGE
AND
ADMINISTRATION
.........................................................................................
11
OVERDOSAGE
...........................................................................................................................
12
ACTION
AND
CLINICAL
PHARMACOLOGY
........................................................................
13
STORAGE
AND
STABILITY
.....................................................................................................
14
SPECIAL
HANDLING
INSTRUCTIONS
...................................................................................
14
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ......................................................... 15
PART II: SCIENTIFIC INFORMATION
..................................................................................
17
PHARMACEUTICAL
INFORMATION
..................