מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
GEMCITABINE AS HYDROCHLORIDE
ELI LILLY ISRAEL LTD
L01BC
LYOPHILIC POWDER FOR CONCENTRATED INFUSION
GEMCITABINE AS HYDROCHLORIDE 1 G/VIAL
I.V
Required
LILLY FRANCE S.A.S., FRANCE
PYRIMIDINE ANALOGUES
Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer. Gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. Breast cancer: Gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Ovarian cancer: Gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.
2012-07-17
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ךיראת 07 - OCT-2014 םש רישכת תילגנאב רפסמו :םושירה GEMZAR 200 MG רפסמ :םושיר 103-72-28801-00/01 GEMZAR 1000 MG רפסמ :םושיר 103-73-2880100/201 םש לעב םושירה : ילא יליל לארשי ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE תפסות 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Posterior reversible encephalopathy syndrome Reports of posterior reversible encephalopathy syndrome (PRES) with potentially severe consequences have been reported in patients receiving gemcitabine as single agent or in combination with other chemotherapeutic agents. Acute hypertension and seizure activity were reported in most gemcitabine patients experiencing PRES, but other symptoms such as headache, lethargy, confusion and blindness could also be present. Diagnosis is optimally confirmed by magnetic resonance imaging (MRI). PRES was typically reversible with appropriate supportive measures. Gemcitabine should be permanently discontinued and supportive measures implemented, including blood pressure control and anti-seizure therapy, if PRES develops during therapy. ADVERSE EVENTS תפסות 4.8 UNDESIRABLE EFFECTS NERVOUS SYSTEM DISORDERS Very rare - Posterior reversible encephalopathy syndrome (see section 4.4.) ב"צמ ובש ,ןולעה נמוסמ תו תורמחהה שקובמה תו לע עקר בוהצ . רבעוה ראודב ינורטקלא ................ךיראתב לכ םייונישה םילוע הנקב דחא םע יאנת םושירה תדועת( תדועת ,םושירה תוכיאה ספוטו יטרפ רישכתה .)ינכדעה לכ בותכה תעצהב םאות ,ןולעה תא יאנת .םושירה םייק ןולע ןכרצל אוהו ןכ קרא את המסמך השלם
X GEMZVL F 05 1. TRADE NAME OF THE MEDICINAL PRODUCT GEMZAR 1,000 mg powder for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 1,000 mg gemcitabine. After reconstitution, the solution contains 38 mg/ml of gemcitabine. _Excipients: _ Each 1,000 mg vial contains 17.5 mg (<1 mmol) sodium. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white plug or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Non-Small Cell Lung Cancer: _ Gemcitabine is indicated for the palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer. _Breast cancer: _ Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant / neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. _Pancreatic Cancer: _ Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer. _Bladder Cancer: _ Gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. Page 1 of 21 X GEMZVL F 05 _Ovarian cancer:_ Gemcitabine in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma who have relapsed at least six months after platinum-based therapy. 4.2_ _ POSOLOGY AND METHOD OF ADMINISTRATION Gemcitabine should only be prescribed by a physician qualified in the use of anti- cancer chemotherapy. Recommended posology: _ _ _Non-Small Cell Lung Cancer:_ _Single-agent use: _ Adults: The recommended dose of gemcitabine is 1,000 mg/m 2 , given by 30 minute intravenous infusion. This should be repeated once weekly for three weeks, followed by a one week rest period. This four week cycle i קרא את המסמך השלם