CAPRELSA 100 MG

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

VANDETANIB

Beszerezhető a:

SANOFI ISRAEL LTD

ATC-kód:

L01XE12

Gyógyszerészeti forma:

FILM COATED TABLETS

Összetétel:

VANDETANIB 100 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

GENZYME EUROPE B.V., THE NETHERLANDS

Terápiás terület:

VANDETANIB

Terápiás javallatok:

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.

Engedély dátuma:

2018-01-31

Betegtájékoztató

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

Termékjellemzők

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