DOXORUBICIN HYDROCHLORIDE INJECTION, USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DOXORUBICIN HYDROCHLORIDE

Διαθέσιμο από:

STRIDES PHARMA CANADA INC

Φαρμακολογική κατηγορία (ATC):

L01DB01

INN (Διεθνής Όνομα):

DOXORUBICIN

Δοσολογία:

2MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

DOXORUBICIN HYDROCHLORIDE 2MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

250ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0110825002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-08-05

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
PR
DOXORUBICIN HYDROCHLORIDE INJECTION, USP
doxorubicin hydrochloride injection
2 mg/mL
10 mg (5 mL), 20 mg (10 mL), 50 mg (25 mL)
and 200 mg (100 mL) Vials
STERILE SOLUTION FOR INTRAVENOUS AND INTRAVESICAL USE
ANTINEOPLASTIC AGENT
Strides Pharma Canada Inc.
Date of Revision:
1565, Boul. Lionel-Boulet
July 31, 2020
Varennes, Quebec
J3X 1P7
Submission Control No.: 240378
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
..................................................................................
11
DRUG INTERACTIONS
...................................................................................
12
DOSAGE AND ADMINISTRATION
............................................................... 13
OVERDOSAGE
.................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................. 16
STORAGE AND STABILITY
...........................................................................
17
SPECIAL HANDLING INSTRUCTIONS
........................................................ 17
DOSAGE FORMS, COMPOSITION AND PACKAGING ..............................
19
PART II: SCIENTIFIC INFORMATION
.........................................................................
20
PHARMACEUTICAL INFORMATION
.......................................................... 20
CLINICAL TRIALS
...........................................................................................
21
DETAILED PHARMACOLOGY
.................................................................