ZEJULA 100 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

NIRAPARIB AS TOSYLATE MONOHYDRATE

可用日期:

MEDISON PHARMA LTD

ATC代码:

L01XX54

药物剂型:

HARD CAPSULE

组成:

NIRAPARIB AS TOSYLATE MONOHYDRATE 100 MG

给药途径:

PER OS

处方类型:

Required

厂商:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

治疗领域:

NIRAPARIB

疗效迹象:

Zejula is indicated as monotherapy for the maintenance treatment of adult patients with Zejula is indicated:• as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.• As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

授权日期:

2019-09-01

资料单张

ZEJULA-PIL-0223-V2
Page 1 of 7
Zejula-PIL-ENG-D30-F
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ZEJULA 100 MG
HARD CAPSULES
NAME AND QUANTITY OF ACTIVE INGREDIENT:
Each capsule contains niraparib 100 mg.
For a list of inactive ingredients and allergens in this medicine, see
section 6 ‘ADDITIONAL
INFORMATION’. See also section 2 under 'IMPORTANT INFORMATION ABOUT
SOME OF THIS
MEDICINE’S INGREDIENTS’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
WHAT ZEJULA IS USED FOR?
Zejula is used as a single maintenance treatment in adult patients
with:
-
advanced high-grade epithelial ovarian cancer (FIGO Stages III and
IV), cancer of
the fallopian tubes, or primary peritoneal cancer after full or
partial response to first-
line platinum-based chemotherapy has been achieved.
-
high-grade recurrent epithelial ovarian cancer that is sensitive to
platinum, cancer of
the fallopian tubes (part of the female reproductive system that
connects the ovaries
to the uterus), or primary peritoneal (the membrane lining the
abdomen) cancer that
has responded (fully or partially) to previous treatment with
platinum-based
chemotherapy.
WHAT ZEJULA IS AND HOW IT WORKS?
Zejula contains the active substance niraparib. Niraparib is a type of
anti-cancer medicine
called a PARP inhibitor. PARP inhibitors block an enzyme called poly
[adenosine
diphosphate-ribose] polymerase (PARP). PARP helps cells repair damaged
DNA so blocking
it means that the DNA of cancer cells cannot be repaired. This results
in death of tumor cells,
which helps to control the cancer.
THERAPEUTIC GROUP: an

产品特点

ZEJULA-SPC-0223-V1
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zejula 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains niraparib tosylate monohydrate equivalent
to 100 mg niraparib.
Excipients with known effect
Each hard capsule contains 254.5 mg of lactose monohydrate (see
section 4.4).
Each hard capsule shell also contains 0.0172 mg of the colouring agent
tartrazine (E 102).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Hard capsule white body with “100 mg” printed in black ink and
purple cap with “Niraparib” printed
in white ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zejula is indicated:
•
as monotherapy for the maintenance treatment of adult patients with
advanced epithelial (FIGO
Stages III and IV) high-grade ovarian, fallopian tube or primary
peritoneal cancer who are in
response (complete or partial) following completion of first-line
platinum-based chemotherapy.
_ _
•
as monotherapy for the maintenance treatment of adult patients with
platinum-sensitive relapsed
high grade serous epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in
response (complete or partial) to platinum-based chemotherapy.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Zejula should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
Posology
_First-line ovarian cancer maintenance treatment _
The recommended starting dose of Zejula is 200 mg (two 100-mg
capsules), taken once daily.
However, for those patients who weigh ≥ 77 kg and have baseline
platelet count ≥ 150,000/μL, the
recommended starting dose of Zejula is 300 mg (three 100-mg capsules),
taken once daily (see section
4.4 and 4.8).
_ _
ZEJULA-SPC-0223-V1
Page 2 of 22
_Recurrent ovarian cancer_
_maintenance treatment_
The dose is three 100 mg hard capsules once daily, equivalent to a
total daily dose of 300 mg.
Patients should be encouraged to take