EPIRUBICIN EBEWE epirubicin hydrochloride 10mg/5mL injection

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

epirubicin hydrochloride, Quantity: 10 mg

Dostupné z:

Sandoz Pty Ltd

INN (Medzinárodný Name):

epirubicin hydrochloride

Forma lieku:

Injection, solution

Zloženie:

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

Spôsob podávania:

Intravenous, Intravesical

Počet v balení:

1 vial x 5mL

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Epirubicin has produced responses in a wide spectrum of neoplastic diseases, and is indicated for the treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma, and superficial bladder cancer (Tis, Ta). In bladder cancer, Epirubicin is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage TA multifocal papillary cancers (grade 2 and 3).

Prehľad produktov:

Visual Identification: Clear, red solution, free of particles; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2007-01-10

Súhrn charakteristických

_Product Information Page _
_EPIRUBICIN EBEWE 10mg/5mL, 50mg/25mL, 100mg/50mL, 200mg/100mL
injection _
_05/2015 _
_ _
_Sandoz Pty Ltd _
_ _
_Version 10 _
_ _
_1 _
PRODUCT INFORMATION
EPIRUBICIN EBEWE
® 10MG/5ML, 50MG/25ML,
100MG/50ML, 200MG/100ML INJECTION
NAME OF THE MEDICINE
_ _
Epirubicin hydrochloride
CAS: 56390-09-1
Empirical formula: C
27
H
29
NO
11
.HCI
Molecular Weight: 579.99
DESCRIPTION
_ _
Epirubicin hydrochloride is a red-orange, almost odourless,
hygroscopic powder,
sparingly soluble in water and dilute alcohol.
Structurally, epirubicin hydrochloride differs from doxorubicin
hydrochloride only in
the orientation of the hydroxyl group at the 4 position on the
aminoglycoside ring.
Composition
Active: Epirubicin hydrochloride
Inactive: Sodium chloride, water for injections, and dilute
hydrochloric acid.
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PHARMACOLOGY
The mechanism of action of epirubicin hydrochloride has not been fully
elucidated
but is probably related to its ability to bind DNA. Cell culture
studies have shown cell
penetration, localisation in the nucleus and inhibition of nucleic
acid synthesis and
mitosis. Epirubicin hydrochloride has proved to be active on the
following
experimental tumours: L 1210 ascites and P388 leukaemias, sarcoma SA
180 (solid
and ascitic forms), melanoma B 16, mammary carcinoma, Lewis lung
carcinoma and
colon carcinoma 38.
_Product Information Page _
_EPIRUBICIN EBEWE 10mg/5mL, 50mg/25mL, 100mg/50mL, 200mg/100mL
injection _
_05/2015 _
_ _
_Sandoz Pty Ltd _
_ _
_Version 10 _
_ _
_2 _
The specificity of epirubicin hydrochloride toxicity appears to be
related primarily to
proliferative activity of normal tissue. Thus, bone marrow,
gastrointestinal tract,
lymphoid organs and the gonads are the main normal tissues damaged.
Degenerative
or functional alterations in liver and kidneys were also seen in
animals dosed with
epirubicin hydrochloride.
Like most other anti-tumour and immunosuppressant agents, epirubicin
hydrochloride, under experimental conditions, has mutagenic properties
and is
carcinoge