PHARMORUBICIN RDF POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

EPIRUBICIN HYDROCHLORIDE

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

L01DB03

INN (Διεθνής Όνομα):

EPIRUBICIN

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

EPIRUBICIN HYDROCHLORIDE 50MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

25ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0116901001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2006-08-02

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
PHARMORUBICIN* RDF*
epirubicin hydrochloride for injection
10 mg and 50 mg vials
Antineoplastic agent
Pfizer Canada Inc
Date of Preparation:
17,300 Trans-Canada Highway
June 17, 2004
Kirkland, Quebec H9J 2M5
Control No. 092490
Date of Revision:
October 06, 2004
* TM Pharmacia & Upjohn S.P.A.
Pfizer Canada Inc, Licensee
© Pfizer Canada Inc 2004
2
PRODUCT MONOGRAPH
NAME OF DRUG
PHARMORUBICIN* RDF*
epirubicin hydrochloride for injection
10 mg and 50 mg vials
CAUTION
PHARMORUBICIN RDF (EPIRUBICIN HYDROCHLORIDE INJECTION) IS A POTENT
DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER
CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD COUNTS
AND
HEPATIC
FUNCTION
TESTS
SHOULD
BE
PERFORMED
REGULARLY.
IRREVERSIBLE CARDIAC TOXICITY MAY OCCUR AS THE CUMULATIVE DOSE
APPROACHES 1000 mg/m
2
. CARDIAC MONITORING IS ADVISED IN THOSE PATIENTS
WHO HAVE RECEIVED MEDIASTINAL RADIOTHERAPY, OTHER ANTHRACYCLINE OR
ANTHRACENE THERAPY, WITH PRE-EXISTING CARDIAC DISEASE, OR RECEIVED
PRIOR EPIRUBICIN CUMULATIVE DOSES EXCEEDING 650 mg/m
2
.
SECONDARY
ACUTE
MYELOID
LEUKEMIA
(AML)
WITH
OR
WITHOUT
A
PRELEUKEMIC
PHASE
(MYELODYSPLASTIC
SYNDROME
OR
MDS)
HAS
BEEN
REPORTED IN PATIENTS TREATED WITH EPIRUBICIN-CONTAINING REGIMENS. THE
CUMULATIVE RISK OF DEVELOPING TREATMENT-RELATED AML/MDS IN 7110
PATIENTS WITH EARLY BREAST CANCER WHO RECEIVED ADJUVANT TREATMENT
WITH EPIRUBICIN-CONTAINING REGIMENS WAS ESTIMATED AS 0.27% AT 3 YEARS,
0.46% AT 5 YEARS, AND 0.51% AT 8 YEARS.
3
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
ACTIONS AND CLINICAL PHARMACOLOGY
The mechanism of action of epirubicin, although not completely
elucidated, appears to be related
to its ability to bind to nucleic acids by intercalation of the planar
anthracycline nucleus with the
DNA double helix.
Binding to cell membranes as well as to plasma proteins may also be
involved. Cell culture studies
have demonstrated rapid cell penetration and perinucleolar chromatin
binding, rapid inhibition of
mitotic activity, mutagenesis and chromosomal