Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
PACLITAXEL
NEOPHARM SCIENTIFIC LTD
L01CD01
POWDER FOR SUSPENSION FOR INFUSION
PACLITAXEL 100 MG/VIAL
I.V
Required
CELGENE DISTRIBUTION B.V., THE NETHERLANDS
PACLITAXEL
Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
2016-04-14
דבכנ ת/חקור ,ה/אפור ה/ , א ןסקרב ךות ןתמל יוריעל ףיחרת תנכהל הקבא - ידירו ABRAXANE Powder for Suspension for I.V Infusion ה ולע ן אפורל כדוע ן ב ראוני 2019 וז העדוהב הרמחה םיווהמה םייונישה םיניוצמ ןכו הרמחה םניאש םיפסונ םייוניש הצוח וקב ןמוסמ רסוהש טסקט ,יתחת וקב ןמוסמ ףסוותהש טסקט רמוחה ליעפה : Paclitaxel 100 mg/vial רישכתל רשואמה היוותהה חסונ ןלהל : Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. וכדעה םינ רקיעה םיי ןולעב אפורל שענ ו יעסב םיפ אבה םי : 4.6 FERTILITY, PREGNANCY AND LACTATION ….. Pregnancy There are very limited data on the use of paclitaxel in human pregnancy. Paclitaxel is suspected to cause serious birth defects when administered during pregnancy. Studies in animals have shown reproductive toxicity (see section 5.3). Women of childbearing potential should have a pregnancy test prior to starting treatment with Abraxane. Abraxane should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel. Breast-feeding Paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see section 5.3). It is not known if paclitaxel is excreted in human milk. Because of po Lesen Sie das vollständige Dokument
1 1. NAME OF THE MEDICINAL PRODUCT Abraxane ® 5 mg/ml powder for suspension for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles. Excipients with known effect Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for suspension for infusion. The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg. The powder is white to yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4). Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents. It should not be substituted for or with other paclitaxel formulations. Posology 2 _Breast cancer _ The recommended dose of Abraxane is 260 mg/m 2 administered intravenously over 30 minutes every 3 weeks. _Dose adjustments during treatment of breast cancer _ Patients who experience severe neutropenia (neutrophil count < 500 cells/mm 3 for a week or longer) or severe sensory neuropathy during Abraxane therapy should have the dose reduced to 220 mg/m 2 for subsequent courses. Following recurrence of severe neutropenia or sev Lesen Sie das vollständige Dokument