PMS-CYTARABINE SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CYTARABINE

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

L01BC01

INN (Διεθνής Όνομα):

CYTARABINE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

CYTARABINE 100MG

Οδός χορήγησης:

INTRATHECAL

Μονάδες σε πακέτο:

10ML/VIAL, 20ML/VIAL

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0108854005; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-02-16

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
PMS-CYTARABINE
Cytarabine Solution for Injection
House Standard
Solution for Injection
(20 mg/mL and 100 mg/mL)
ANTILEUKEMIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
February 14, 2017
Submission Control No.: 201917
_pms-CYTARABINE Product Monograph _
_Page 2 of 46_
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
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
.........................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
......................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
DETAILED PHARMACOLOGY
.....