国: イスラエル
言語: 英語
ソース: Ministry of Health
IRINOTECAN HYDROCHLORIDE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
L01XX19
SOLUTION FOR INFUSION
IRINOTECAN HYDROCHLORIDE 20 MG/ML
I.V
Required
PFIZER INC, USA
IRINOTECAN
IRINOTECAN
Campto is indicated for the treatment of patients with metastatic colorectal cancer: In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease. As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. For the treatment of patients with small cell lung cancer. For the treatment of patients with gastric cancer.Irinotecan in combination with leucovorin, Oxaliplatin and 5-fluorouracil for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.
2021-12-31
1 רזייפ יא ףא יפ מ"עב לארשי הקיטבצמרפ רקנש 'חר 9 .ד.ת , 12133 לארשי ,חותיפ הילצרה 46725 :לט 972-9-9700500 :סקפ 972-9-9700501 ינוי 2018 ,ה/דבכנ ת/חקור ,ה/אפור ולעב ןוכדע לע ךעידוהל וננוצרב ן אפורל לש רישכתה CAMPTO :ליעפה ביכרמה IRINOTECAN HYDROCHLORIDE 20MG/ML INDICATED FOR: The treatment of patients with metastatic colorectal cancer: In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease. As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. For the treatment of patients with small cell lung cancer. For the treatment of patients with gastric cancer. Irinotecan in combination with leucovorin, Oxaliplatin and 5-fluorouracil for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.. :אפורל ןולעב םיירקיעה םינוכדעה ןלהל 4.8. UNDESIRABLE EFFECTS .... POST-MARKETING SURVEILLANCE MEDDRA SYSTEM ORGAN CLASS PREFERRED TERM Infections and infestations Pseudomembranous colitis one of which has been documented bacteriologically (_Clostridium _ _difficile_) Sepsis Fungal infections * Viral infections † .... .... e.g. Pneumocystis jirovecii pneumonia, bronchopulmonary aspergillosis, systemic candida. * enza, hepatitis B reactivation, cytomegalovirus colitis. e.g. Herpes zoster, influ † .... .הרמחה םיווהמ בוהצ עקרב םישגדומה םייונישה ינוכדעו עדימ תטמשה ,עדימ תפסות םיללוכה םיפסונ םייוניש ועצוב ,ןכ ומכ .הרמחה םיווהמ םניאש חסונ ולעה םינ כדועמה םי חלשנ ו ךרוצל תואירבה דרשמל מוסרפ ם :תואירבה דרשמ רתאבש תופורתה רגאמב https://www.old.health.gov.il/units/pharmacy/trufot/index.asp?safa=h ולע תלבקל ,ןיפוליחל םינ אלמ םי ספדומ ם 完全なドキュメントを読む
Campto LPD CC 060522 2021-0069540, 2021-0074031 Page 1 of 20 CAMPTO ® 1. NAME OF THE MEDICINAL PRODUCT CAMPTO ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The concentrate contains 20 mg/mL irinotecan hydrochloride, trihydrate (equivalent to 17.33 mg/ml irinotecan). One vial of 2 mL contains 34.66 mg of irinotecan as 40 mg of irinotecan hydrochloride, trihydrate (40 mg/2 mL). One vial of 5 mL contains 86.65 mg of irinotecan as 100 mg of irinotecan hydrochloride, trihydrate (100 mg/5 mL). One vial of 15 mL contains 259.95 mg of irinotecan as 300 mg of irinotecan hydrochloride, trihydrate (300 mg/15 mL). For the full list of excipients, see section 6.1. Excipient(s) with known effect Sorbitol CAMPTO 20 mg/mL concentrate for solution for infusion contains 90 mg of sorbitol in each 2 mL of solution, which is equivalent to 90 mg/2 mL. CAMPTO 20 mg/mL concentrate for solution for infusion contains 225 mg of sorbitol in each 5 mL of solution, which is equivalent to 225 mg/5 mL. CAMPTO 20 mg/mL concentrate for solution for infusion contains 675 mg of sorbitol in each 15 mL of solution, which is equivalent to 675 mg/15 mL. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATION CAMPTO ® is indicated for the treatment of patients with metastatic colorectal cancer: • In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease. • As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. • For the treatment of patients with small cell lung cancer. • For the treatment of patients with gastric cancer. • Irinotecan in combination with leucovorin, oxaliplatin and 5-fluorouracil for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (based on NCCN guidelines, version 2.2015). Campto LPD CC 060522 2021-0069540, 2021-0074031 Page 2 of 20 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For adults only. CAMPTO ® solution for infusion should 完全なドキュメントを読む