VENCLEXTA 50 MG TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VENETOCLAX

متاح من:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC رمز:

L01XX52

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

VENETOCLAX 50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ABBVIE INC., USA

المجال العلاجي:

VENETOCLAX

الخصائص العلاجية:

Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaVENCLEXTA in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), who have received at least one prior therapy.VENCLEXTA in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).Acute Myeloid LeukemiaVENCLEXTA in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

تاريخ الترخيص:

2022-03-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with
a doctor’s prescription only
VENCLEXTA
® 10 MG TABLETS
VENCLEXTA
® 50 MG TABLETS
VENCLEXTA
® 100 MG TABLETS
FILM-COATED TABLETS
THE ACTIVE SUBSTANCE AND ITS QUANTITY:
Each Venclexta 10 mg tablet contains 10 mg
venetoclax
Each Venclexta 50 mg tablet contains 50 mg
venetoclax
Each Venclexta 100 mg tablet contains 100 mg
venetoclax
For the list of inactive ingredients, please see section
6 “Further Information” in this leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for your ailment/
for you. Do not pass it on to others. It may harm them
even if it seems to you that their ailment/medical
condition is similar.
IN ADDITION TO THE LEAFLET, THE MEDICINE VENCLEXTA
HAS A ‘QUICK START GUIDE’ FOR CLL/SLL PATIENTS.
THIS GUIDE INCLUDES IMPORTANT GUIDELINES REGARDING
THE START OF THE TREATMENT, WHICH YOU SHOULD
KNOW. READ THE ‘QUICK START GUIDE’ THAT COMES
WITH THE ‘CLL/SLL STARTING PACK’ BEFORE STARTING
TREATMENT WITH THE MEDICINE. KEEP THE GUIDE FOR
LATER REFERENCE IF NEEDED.
1. WHAT IS THE MEDICINE INTENDED FOR?
Venclexta, as monotherapy or in combination with
rituximab, is intended for the treatment of patients
with chronic lymphocytic leukemia )CLL) or patients
with small lymphocytic lymphoma )SLL), who have
received at least one prior treatment.
Venclexta, in combination with obinutuzumab, is
intended for the treatment of patients with previously
untreated chronic lymphocytic leukemia )CLL) or
patients with small lymphocytic lymphoma )SLL).
Venclexta, in combination with hypomethylating
agents or in combination with low-dose cytarabine,
is intended for the treatment of patients with newly
diagnosed acute myeloid leukemia )AML) who are
not eligible for intense chemotherapy.
THERAPEUTI

خصائص المنتج

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VENCLEXTA
® 10 MG TABLETS
VENCLEXTA
® 50 MG TABLETS
VENCLEXTA
® 100 MG TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Venclexta 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of venetoclax.
Venclexta 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of venetoclax.
Venclexta 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of venetoclax.
For the full list of inactive ingredients, see section
11
.
PATIENT QUICK START GUIDE
The 'Patient Quick Start Guide', includes instructions regarding the
correct medication
schedule and safety information for CLL/SLL Patients. Please explain
to the patient the need
to review the guide before starting treatment. The 'Patient Quick
Start Guide' is included in the
'CLL/SLL Starting Pack'.
1 INDICATIONS AND USAGE
1.1 CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
VENCLEXTA in combination with rituximab or as monotherapy is indicated
for the treatment
of adult patients with chronic lymphocytic leukaemia (CLL) or small
lymphocytic lymphoma
(SLL), who have received at least one prior therapy.
VENCLEXTA in combination with obinutuzumab is indicated for the
treatment of patients
with previously untreated chronic lymphocytic leukaemia (CLL) or small
lymphocytic
lymphoma (SLL).
1.2 ACUTE MYELOID LEUKEMIA
VENCLEXTA in combination with a hypomethylating agent or in
combination with low dose
cytarabine is indicated for newly diagnosed patients with acute
myeloid leukemia (AML) who
are ineligible for intensive chemotherapy.
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2 DOSAGE AND ADMINISTRATION
2.1
IMPORTANT SAFETY INFORMATION
Assess patient-specific factors for level of risk of tumor lysis
syndrome (TLS) and provide
prophylactic hydration and anti-hyperuricemics to patients prior to
first dose of VENCLEXTA
to reduce risk of TLS
_[see Dosage and Administration (2.4) and Warnings and Precautions _
_(5.1)]_
.
2.2 RECOMMENDED DOSAGE FOR CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL
LYMPHOCYTIC
LYMPHOMA
VENCLEXTA dosing beg