ADRIAMYCIN RDF POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DOXORUBICIN HYDROCHLORIDE

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

L01DB01

INN (International Nazwa):

DOXORUBICIN

Dawkowanie:

150MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

DOXORUBICIN HYDROCHLORIDE 150MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

150MG/VIAL

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0110825004; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2006-08-02

Charakterystyka produktu

PRODUCT MONOGRAPH
ADRIAMYCIN
*
RDF
*
(doxorubicin hydrochloride for Injection USP)
10 mg, 50 mg and 150 mg Vials
Antineoplastic agent
Pfizer Canada Inc
Date of Preparation:
17,300 Trans-Canada Highway
11 September 2003
Kirkland, Quebec H9J 2M5
Control No. 086543
* TM Pharmacia Enterprises S.A.
Pfizer Canada Inc, Licensee
© Pfizer Canada Inc 2003
2
NAME OF DRUG
ADRIAMYCIN
*
RDF
*
Doxorubicin Hydrochloride for Injection USP
10 mg, 50 mg and 150 mg Vials
CAUTION:
ADRIAMYCIN (DOXORUBICIN HYDROCHLORIDE) IS A POTENT DRUG AND
SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER
CHEMOTHERAPY DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD
COUNTS
AND
HEPATIC
FUNCTION
TESTS
SHOULD
BE
PERFORMED
REGULARLY. BECAUSE OF THE EXPERIENCE WITH CARDIAC TOXICITY, IT IS
NOT RECOMMENDED TO EXCEED A TOTAL DOSE OF ADRIAMYCIN 550 MG/M
2
WITH THE 21 DAY REGIMEN AND 700 MG/M
2
WITH THE WEEKLY REGIMEN.
CARDIAC
MONITORING
IS
ADVISED
IN
THOSE
PATIENTS
WHO
HAVE
RECEIVED
MEDIASTINAL
RADIOTHERAPY,
OTHER
ANTHRACYCLINE
OR
ANTHRACENE THERAPY, WITH PRE-EXISTING CARDIAC DISEASE, OR WHO
HAVE RECEIVED PRIOR ADRIAMYCIN CUMULATIVE DOSES EXCEEDING 400
MG/M
2
WITH THE 21 DAY REGIMEN AND 550 MG/M
2
UTILIZING THE WEEKLY
REGIMEN.
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CLINICAL PHARMACOLOGY
Though not completely elucidated, the mechanism of action of
doxorubicin is related to its
ability to bind to DNA and inhibit nucleic acid synthesis. Cell
culture studies have
demonstrated rapid cell penetration and perinucleolar chromatin
binding, rapid inhibition of
mitotic activity and nucleic acid synthesis, mutagenesis and
chromosomal aberrations.
Animal studies have shown activity in a wide spectrum of experimental
tumours,
immunosuppression, carcinogenic properties in rodents, induction of a
variety of toxic
effects, including delayed and progressive cardiac toxicity,
myelosuppression in all species
and atrophy of testes in rats and dogs.
3
Pharmacokinetic studies show that the intravenous administration of
normal or radiolabelled
ADRIAMYCIN (doxorubicin hy