MYLAN EPIRUBICIN HYDROCHLORIDE 2 MGML INJECTION

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

EPIRUBICIN HYDROCHLORIDE

Disponible depuis:

MYLAN HEALTHCARE SDN. BHD.

DCI (Dénomination commune internationale):

EPIRUBICIN HYDROCHLORIDE

Unités en paquet:

25ml mL

Fabriqué par:

Mylan Laboratories Limited (OTL)

Résumé des caractéristiques du produit

VERSION & DATE
SPECIAL INSTRUCTIONS
BUYER / COUNTRY
PRODUC T
DIMENSIO N
COLOUR SHADES
AR TW ORK DET AI L LAB EL
Pack
Component
No. of Colours
Black
Mylan Epirubicin Hydrochloride Injection
Mylan / Malaysia
NA
Ver: 4; Date: 31.05.2019
Pack Insert
1
-
240 x 320 mm
FRONT SIDE
PRODUCT DESCRIPTION
Epirubicin Hydrochloride Injection 2 mg/ml is a clear, red solution
filled in glass vial with rubber stopper
and aluminium seal.
COMPOSITION
Each 25ml vial contains: Epirubicin 50 mg
PHARMACOLOGY
The mechanism of action of Epirubicin 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 has proved to be
active on the following experimental
tumours: L 1210 ascites and P588 leukemias, sarcoma SA 140 solid and
ascetic formed, melanoma 8
16, mammary carcinoma, Lewis lung carcinoma and colon carcinoma 36.
The specificity of Epirubicin 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 the liver
and kidneys were also seen in
animals dosed with Epirubicin.
Like most antitumour and immunosuppressant agents, Epirubicin, under
experimental conditions,
has mutagenic properties and is carcinogenic in laboratory animals.
Toxicity studies in animals have
indicated that on a weight (mg/mg) basis, Epirubicln CS has a better
therapeutic index and less
systemic and cardiac toxicity than doxorubicin
PHARMACOKINETICS
In patients with normal hepatic and renal function, plasma levels
after IV injection of 75-90 mg/m
2
of
Epiubicin follow a tri-exponential decreasing pattern with a very fast
1st phase and a slow terminal
phase with a mean half-life of about 40 hrs. Plasma levels of
Epirubicin HCI main metabolite, the 13-
OH derivative, are constantly somewhat lower and virtually parallel to
those