DOXORUBICIN EBEWE doxorubicin hydrochloride 100mg/50mL injection vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

doxorubicin hydrochloride, Quantity: 100 mg

Disponible desde:

Sandoz Pty Ltd

Designación común internacional (DCI):

Doxorubicin hydrochloride

formulario farmacéutico:

Injection

Composición:

Excipient Ingredients: water for injections; dilute hydrochloric acid; sodium chloride

Vía de administración:

Intravenous, Intravesical

Unidades en paquete:

1 vial

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Doxorubicin has been successfully used to produce regression in neoplastic conditions, eg acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin's and non-Hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas and ovarian carcinoma, etc. The main antitumour activities are listed in Table 1. Doxorubicin is also indicated in the primary management of nonmetastatic carcinoma of the bladder (Tis, T1, T2) by intravesical administration.

Resumen del producto:

Visual Identification: Clear blood-red solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2005-04-29

Ficha técnica

_Product Information _
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_Doxorubicin Ebewe injection _
04/2014
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_Sandoz Pty Ltd _
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_Version 05 _
PRODUCT INFORMATION
DOXORUBICIN EBEWE
® 10MG/5ML, 50MG/25ML, 100MG/50ML, 200MG/100ML
INJECTION
NAME OF THE MEDICINE
Doxorubicin
COMPOSITION
Active. Doxorubicin hydrochloride.
Inactive. Sodium chloride, dilute hydrochloric acid and water for
injections.
DESCRIPTION
Doxorubicin hydrochloride: Molecular formula, C
27
H
29
NO
11
.HCl.; MW, 580.0 and CAS number,
25316-40-9. It is soluble in water and slightly soluble in methanol.
Doxorubicin hydrochloride solution for injection is red in colour.
Doxorubicin
hydrochloride
is
a
cytotoxic
anthracycline
antibiotic
isolated
from
cultures
of
_Streptomyces peucetius _variant_ caesius_. The chemical structure of
doxorubicin consists of a tetracyclic
ring with the sugar daunosamine attached by a glycosidic linkage.
Structurally, doxorubicin is related
to daunomycin (daunorubicin) and differs only in hydroxyl group
substitution (instead of hydrogen) at
the alkyl side chain at position '9' of the 'A' ring. It is supplied
in solution form containing sodium
chloride.
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.
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_Doxorubicin Ebewe injection _
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Doxorubicin has immunosuppressive effects. It inhibits the titre of
haemolytic and haemagglutinating
antibodies in mice immunised with sheep red blood cells. Similar
evidence in humans indicates that
doxorubicin is a powerful but temporary immunosuppressant agent.
Doxorubicin is a cell cycle, phase
nonspecific cytotoxic medicine.
The toxic effects of doxorubicin on the bone marrow appear to be
related to its