País: Israel
Idioma: inglés
Fuente: Ministry of Health
GEMCITABINE AS HYDROCHLORIDE
TZAMAL BIO-PHARMA LTD
L01BC05
POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE AS HYDROCHLORIDE 1500 MG
I.V
Required
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
GEMCITABINE
GEMCITABINE
Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locallyadvanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreaticcancer.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 locallyrecurrent 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 epithelialovarian carcinoma whom have relapsed at least six months after platinum - based therapy.
2015-05-31
טסוגוא 2019 ה/דבכנ ת/חקור ,ה/אפור , :ןודנה Gemcitabine medac 200 mg - ןיבטיצמג קאדמ 200 ג"מ g 0 m 00 1 Gemcitabine medac - ןיבטיצמג קאדמ 0 0 0 1 ג"מ mg 0 0 5 1 Gemcitabine medac - ןיבטיצמג קאדמ 0 0 15 ג"מ ליעפ ביכרמ : Gemcitabine medac 200 mg: 200mg Gemcitabine Gemcitabine medac 100 mg: 1000 mg Gemcitabine Gemcitabine medac 150 mg: 1500 mg Gemcitabine ןונימ תרוצ : Powder For Solution For Infusion תויוותה תורשואמ : 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. תרבח מצ ויב ל - המראפ מ"עב תשקבמ עידוהל םכ לע ה םינוכדע םיאבה ןולעב אפורל ה לש רישכת . תועצמאב תנמוסמ הרמחה תחת וק י ש , ועמשמ הל רושקה עדימ תפסות איה ות הרמח . 4.2 Posology and method of administration Recommended posology: Cisplatin has been used at doses between 75-100 mg/ m 2 once every 3 or 4 weeks Paediatric population (<18 years) Gemcitabine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy. Posterior reversible encephalopathy syndrome Reports of posterior reversible encephalopathy syn Leer el documento completo
GEM_PI_PI_app_TZ_04.2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gemcitabine medac 200 mg Gemcitabine medac 1000 mg Gemcitabine medac 1500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine. One vial contains gemcitabine hydrochloride equivalent to 1,000 mg gemcitabine. One vial contains gemcitabine hydrochloride equivalent to 1,500 mg gemcitabine. After reconstitution, the solution contains 38 mg/ml of gemcitabine. Excipients with known effect Each 200 mg vial contains 3.5 mg (< 1 mmol) sodium. Each 1,000 mg vial contains 17.5 mg (< 1 mmol) sodium. Each 1,500 mg vial contains 26.3 mg (> 1 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion White to off-white 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. GEM_PI_PI_app_TZ_04.2021 _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 qual Leer el documento completo