Страна: Израел
Език: английски
Източник: Ministry of Health
TOPOTECAN AS HYDROCHLORIDE
NOVARTIS ISRAEL LTD
L01XX17
POWDER FOR SOLUTION FOR INFUSION
TOPOTECAN AS HYDROCHLORIDE 4 MG/VIAL
I.V
Required
GLAXO SMITH KLINE MANUFACTURING SPA,ITALY
TOPOTECAN
TOPOTECAN
Topotecan monotherapy is indicated for the treatment of:• patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.• patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.
2022-03-31
אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת 02/2014 םושירה רפסמו תילגנאב רישכת םש HYCAMTIN: 104-89-28936 םושירה לעב םש GLAXOSMITHKLINE )ISRAEL( LTD : ! דבלב תורמחהה טורפל דעוימ הז ספוט אפורל ןולעב אפורל ןולעב תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט UNDESIRABLE EFFECTS BLOOD AND LYMPHATIC SYSTEM DISORDERS Very Common: Anaemia, febrile neutropenia, leucopenia, neutropenia, thrombocytopenia Not known: Severe bleeding )associated with thrombocytopenia( BLOOD AND LYMPHATIC SYSTEM DISORDERS Very common: febrile neutropenia, neutropenia )see Gastrointestinal disorders(, thrombocytopenia, anaemia, leucopenia Common: pancytopenia Not known: severe bleeding )associated with thrombocytopenia( SKIN AND SUBCUTANEOUS DISORDERS Very Common: Alopecia SKIN AND SUBCUTANEOUS TISSUE DISORDERS Very common: alopecia Common: pruritus INFECTIONS AND INFESTATIONS Common: Infection, sepsis )see Warnings and Precautions( INFECTIONS AND INFESTATIONS Very common: infection Common: sepsis IMMUNE SYSTEM DISORDERS Common: Hypersensitivity, including rash IMMUNE SYSTEM DISORDERS Common: hypersensitivity reaction including rash Rare: anaphylactic reaction, angioedema, urticaria - The incidence of adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status )see section 4.4(. OVERDOSAGE SYMPTOMS AND SIGNS The primary complications of overdosage are anticipated to be bone marrow suppression and stomatitis. TREATMENT There is no known antidote for topotecan overdosage. Overdoses (up to 10-fold of the prescribed dose) occurred in patients treated with intravenous topotecan. The primary complication of overdosage is bone marrow suppression. The observed signs and symptoms of overdose are consistent w Прочетете целия документ
HYC IV API DEC20 V 3 1. NAME OF THE MEDICINAL PRODUCT HYCAMTIN ® I.V. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 4 mg topotecan (as hydrochloride). The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. Light yellow to greenish cake. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1). 4.2 Posology and method of administration The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy. Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6). Posology When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 10 9 /l, a platelet count of ≥ 100 x 10 9 /l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary). Ovarian and small cell lung carcinoma HYC IV API DEC20 V3 Initial dose The recommended dose of topotecan is 1.5 mg/m 2 body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each Прочетете целия документ