LYNPARZA 150 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

OLAPARIB

متاح من:

ASTRAZENECA (ISRAEL) LTD

ATC رمز:

L01XX46

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

OLAPARIB 150 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ASTRA ZENECA UK LIMITED

المجال العلاجي:

OLAPARIB

الخصائص العلاجية:

Ovarian cancer:Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.First-line Maintenance Treatment of Advanced Ovarian Cancer in Combination with BevacizumabLynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:• a deleterious or suspected deleterious BRCA mutation, and/or• genomic instability Breast cancer:Germline BRCA-mutated HER2-negative Metastatic Breast CancerLynparza is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.Adjuvant Treatment of Germline BRCA-mutated HER2-negative High Risk Early Breast Cancer Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Adenocarcinoma of the pancreas:First-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic AdenocarcinomaLynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.Prostate cancer:germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancerLynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.

تاريخ الترخيص:

2019-01-21

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
Lynparza
®
100 mg
Film-coated tablets
Composition:
Each tablet contains:
Olaparib 100 mg
Lynparza
®
150 mg
Film-coated tablets
Composition:
Each tablet contains:
Olaparib 150 mg
For inactive ingredients, please see section 6 – “Further
Information”.
Please see also section 2 – "Important information regarding some of
the medicine
ingredients".
Read this leaflet carefully in its entirety before using the medicine.
Keep this leaflet. You may need it again.
This leaflet contains concise information about the medicine. If you
have any further
questions, ask your doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It
may harm them, even if it seems to you that their ailment is similar.
1. WHAT THE MEDICINE INTENDED FOR?
Lynparza is intended for:
Ovarian cancer:
•
Monotherapy, maintenance treatment of adult patients with advanced
BRCA1/2-mutated (germline or somatic) high-grade epithelial ovarian
(fallopian tube or primary peritoneal) cancer who are in response
(complete
or partial) to first-line platinum-based chemotherapy.
•
Maintenance treatment of patients with platinum-sensitive relapsed
high-
grade epithelial ovarian (or fallopian tube, or primary peritoneal)
cancer who
are
in response (complete response or partial response) to first-line
platinum-based chemotherapy.
•
For the maintenance treatment, in combination with bevacizumab, of
adult
patients with advanced epithelial ovarian, fallopian tube or primary
peritoneal
cancer who are in complete or partial response to first-line
platinum-based
chemotherapy and whose cancer is associated with homologous
recombination deficiency (HRD) positive status defined by either:
-
a deleterious or suspected deleterious BRCA mutation, and/or
-
genomic instability
Breast cancer:
•
For the treatment of metastatic breast cancer in patients with
mutati

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lynparza 100 mg film-coated tablets
Lynparza 150 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lynparza 100 mg film-coated tablets
Each film-coated tablet contains 100 mg olaparib.
Lynparza 150 mg film-coated tablets
Each film-coated tablet contains 150 mg olaparib.
Excipient with known effect
:
This medicinal product contains 0.24 mg sodium per 100 mg tablet and
0.35 mg sodium per
150 mg tablet, i.e.
essentially “sodium
-
free”.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Lynparza 100 mg film-coated tablets
Yellow to dark yellow, oval, bi-
convex tablet, debossed with ‘OP100’ on one side and plai
n on
the other side.
Lynparza 150 mg film-coated tablets
Green to green/grey, oval, bi-
convex tablet, debossed with ‘OP150’ on
one side and plain on
the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OVARIAN CANCER
Lynparza is indicated as monotherapy for the:
•
maintenance treatment of adult patients with advanced (FIGO stages III
and IV) _BRCA1/2_-
mutated (germline and/or somatic) high-grade epithelial ovarian,
fallopian tube or primary
peritoneal cancer who are in response (complete or partial) following
completion of first-line
platinum-based chemotherapy.
•
Maintenance treatment of adult patients with
platinum-sensitive relapsed high-grade
epithelial ovarian, fallopian tube, or primary peritoneal cancer who
are in response
(complete response or partial response) to platinum-based
chemotherapy.
First-line Maintenance Treatment of Advanced Ovarian Cancer in
Combination with
Bevacizumab
Lynparza is indicated in combination with bevacizumab for the
maintenance treatment of adult
patients with advanced epithelial ovarian, fallopian tube or primary
peritoneal cancer who are in
complete or partial response to first-line platinum-based chemotherapy
and whose cancer is
associated with homologous recombination deficiency (HRD) positive
status def