البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
DOXORUBICIN HYDROCHLORIDE
MEDISON PHARMA LTD
L01DB01
POWDER,DISPERSION AND SOLVENT FOR CONCENTRATE FOR DISPERSION FOR INFUSION
DOXORUBICIN HYDROCHLORIDE 50 MG VIALS
I.V
Required
GP-PHARM POLIGON INDUSTIRAL ELS VINYETS-ELS FOGARS, SPAIN
DOXORUBICIN
DOXORUBICIN
Myocet, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in women.
2016-01-31
– )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולע :ךיראת 30.12.2013 :תילגנאב רישכת םש MYOCET :םושיר רפסמ 145-22-33081-00 מ"עב המראפ ןוסידמ :םושירה לעב םש ןולעב םייונישה בוהצ עקר לע םינמוסמ אפורל ןולעב םי/שקובמה םי/יונישה לע םיטרפ ןולעב קרפ יחכונ טסקט שדח טסקט 4.8 UNDESIRABLE EFFECTS SKIN AND SUBCUTANEOUS TISSUE DISORDERS Alopecia Very Comm on Comm on Rash Comm on Not known Nail disorder Comm on Uncom mon Pruritus Uncom mon Uncom mon Folliculitis Uncom mon Uncom mon Dry skin Uncom mon Not known SKIN AND SUBCUTANEOUS TISSUE DISORDERS Alopecia Very Comm on Comm on Rash Comm on Not known Palmar- plantar erythrodysa esthesia syndrome Not known Not known Nail disorder Comm on Uncom mon Pruritus Uncom mon Uncom mon Folliculitis Uncom mon Uncom mon Dry skin Uncom mon Not known ב"צמ ובש ,ןולע םינמוסמ תורמחהה תושקובמה לע עקר בוהצ . םייוניש םניאש רדגב תורמחהה ונמוס ןולעב עבצב הנוש . רבעוה ראודב ינורטקלא ךיראתב 30.12.2013 اقرأ الوثيقة كاملة
1 PHYSICIAN PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Myocet 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Liposome–encapsulated doxorubicin–citrate complex corresponding to 50 mg doxorubicin hydrochloride (HCl). Excipient(s) with known effect: The reconstituted medicinal product contains approximately 108 mg sodium for a 50 mg doxorubicin HCl dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder, dispersion and solvent for concentrate for dispersion for infusion Myocet is supplied as a three-vial system: Myocet doxorubicin HCl is a red lyophilised powder. Myocet liposomes is a white to off-white, opaque and homogeneous dispersion. Myocet buffer is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myocet, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in adult women._ _ _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of Myocet should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy. Posology When Myocet is administered in combination with cyclophosphamide (600 mg/m 2 ) the initial recommended dose of Myocet is 60-75 mg/m 2 every three weeks. _Elderly patients _ Safety and efficacy of Myocet have been assessed in 61 patients with metastatic breast cancer, age 65 and over. Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet in this population was comparable to that observed in patients less than 65 years old. _Patients with impaired hepatic function _ As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, evaluation of hepatobiliary function should be performed before and during therapy with Myocet. 2 Based on limited data in patients with liver metastases, it is recommende اقرأ الوثيقة كاملة