البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EPIRUBICIN HYDROCHLORIDE
MYLAN HEALTHCARE SDN. BHD.
EPIRUBICIN HYDROCHLORIDE
25ml mL
Mylan Laboratories Limited (OTL)
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 اقرأ الوثيقة كاملة