Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
VANDETANIB
SANOFI ISRAEL LTD
L01XE12
FILM COATED TABLETS
VANDETANIB 100 MG
PER OS
Required
GENZYME EUROPE B.V., THE NETHERLANDS
VANDETANIB
Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.
2018-01-31
CAP TAB AC SH011116 לפוטמל עדימ יתוחיטב עדימ ליכמ הז סיטרכ • ינפל ,תעדל ךילעש ,בושח הסלרפקב לופיטה תלחתה .הסלרפקב לופיטה ךלהמבו ברועמה אפור לכל הז סיטרכ גצה • .ךלופיטב אדוו אנא ,אפורה לצא רוקיב לכב תופורתה לכ לש המישר ךל שיש .לטונ התאש תופסונה :לפוטמה םש :אפורה םש :אפורה לש ןופלטה רפסמ :הסלרפקב לופיטה תליחת ךיראת :לפוטמל הרהזא סיטרכ TM הסלרפק ( VANDETANIB ) INFORMATION FOR THE PATIENT • THIS CARD CONTAINS IMPORTANT SAFETY INFORMATION THAT YOU SHOULD KNOW BEFORE YOU ARE GIVEN CAPRELSA AND DURING TREATMENT WITH CAPRELSA. • SHOW THIS CARD TO ANY DOCTOR INVOLVED IN YOUR TREATMENT. PLEASE MAKE SURE THAT YOU HAVE A LIST OF ALL YOUR OTHER MEDICINES WITH YOU AT ANY VISIT TO YOUR DOCTOR. PATIENT’S NAME: DOCTOR’S NAME: DOCTOR’S TELEPHONE NUMBER: START DATE OF CAPRELSA TREATMENT: PATIENT ALERT CARD: CAPRELSA ® (VANDETANIB) תוליעפב יונישל םורגל הלולע הסלרפק תארקנה ,ךלש בלה לש תילמשחה וז העפות , QT עטקמ תכראה תורידס אל בל תוקיפדל םורגל הלולע תויהל םילולעה בלה בצקב םייונישו .םייח ינכסמ POSTERIOR :תארקנה חומב תנומסת REVERSIBLE ENCEPHALOPATHY םג העודי) SYNDROME (PRES) REVERSIBLE POSTERIOR :םשב LEUKOENCEPHALOPATHY SYNDROME תליטנ ןמזב םרגיהל הלולע ([RPLS] .הסלרפק תא עדי אנא הסלרפקב לופיטה ךלהמב :ה/שח ךניה םא דימ ךלש אפורה תוקיפד וא תרוחרחס ,ןופליע תשוחת • תויהל םילוכי ולא ,תורידס אל בל . QT עטקמ תכראה לש םינמיס ,לובלב ,תותיווע ,םיסוכרפ ,שאר באכ • ולא ,הבישחב וא הייארב הערפה תנומסת לש םינמיס תויהל םילוכי .P Leggi il documento completo
CAPR-TAB-SPC-V7.0 1. NAME OF THE MEDICINAL PRODUCT CAPRELSA100 mg, film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 100 mg of vandetanib. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM The Caprelsa 100 mg tablet is a round, biconvex, white film-coated tablet with ‘Z100’ impressed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in treatment of MTC and in the use of anticancer medicinal products and experienced in the assessment of electrocardiogram (ECG). Only one supply per prescription is allowed. For a further supply, a new prescription is required. PATIENT SAFETY INFORMATION CARD The marketing of Caprelsa is subject to a risk management plan (RMP) including a 'Patient safety information card'. The 'Patient safety information card', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain the patient the need to review the card before starting treatment. Posology The recommended dose is 300 mg once a day, taken with or without food at about the same time each day. If a dose is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose. Patients treated with Caprelsa must be given the patient alert card and be informed about the risks of Caprelsa (see also Leggi il documento completo