DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
26-06-2019

Aktīvā sastāvdaļa:

DOXORUBICIN HYDROCHLORIDE

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

L01DB01

SNN (starptautisko nepatentēto nosaukumu):

DOXORUBICIN

Deva:

2MG

Zāļu forma:

SOLUTION

Kompozīcija:

DOXORUBICIN HYDROCHLORIDE 2MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

5/25/100ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2021-04-21

Produkta apraksts

                                _ _
_Doxorubicin Hydrochloride Injection _
_Page 1 of 46_
PRODUCT MONOGRAPH
PR
DOXORUBICIN HYDROCHLORIDE INJECTION
doxorubicin hydrochloride
2 mg/mL
10 mg (5 mL), 50 mg (25 mL) and 200 mg (100 mL) Vials
Manufacturer’s Standard
ANTINEOPLASTIC AGENT
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision: June 26, 2019
Submission Control No: 228706
_ _
_Doxorubicin Hydrochloride Injection _
_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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
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
.........................................
                                
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