DOXORUBICIN EBEWE doxorubicin hydrochloride 200mg/100mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

doxorubicin hydrochloride, Quantity: 200 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Doxorubicin hydrochloride

Pharmaceutical form:

Injection

Composition:

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

Administration route:

Intravenous, Intravesical

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Registered

Authorization date:

2005-04-29

Summary of Product characteristics

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_Doxorubicin Ebewe injection _
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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 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