CLADRIBINE INJECTION SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

CLADRIBINE

Disponibbli minn:

GENERIC MEDICAL PARTNERS INC

Kodiċi ATC:

L01BB04

INN (Isem Internazzjonali):

CLADRIBINE

Dożaġġ:

1MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

CLADRIBINE 1MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0124270001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2019-12-04

Karatteristiċi tal-prodott

IMPORTANT: PLEASE READ
PRODUCT MONOGRAPH
Pr
CLADRIBINE INJECTION
Solution for Intravenous Injection 1 mg / mL
USP
Antineoplastic/Chemotherapeutic Agent
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 406
Toronto, Ontario
M3B 3K4
Date of Preparation:
December 3, 2019
CONTROL NO.: 225548
IMPORTANT: PLEASE READ
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
3
WARNINGS AND PRECAUTIONS
.....................................................................................
3
ADVERSE REACTIONS
.......................................................................................................
7
DRUG INTERACTIONS
.....................................................................................................
10
DOSAGE AND ADMINISTRATION
.................................................................................
11
OVERDOSAGE
....................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 13
STORAGE AND STABILITY
.............................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 16
PART II: SCIENTIFIC INFORMATION
...........................................................................
17
PHARMACEUTICAL INFORMATION
.............................................................................
17
CLINICAL TRIALS