ZYTIGA 250 MG

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

ABIRATERONE ACETATE

Предлага се от:

J-C HEALTH CARE LTD

АТС код:

L02BX03

Лекарствена форма:

TABLETS

Композиция:

ABIRATERONE ACETATE 250 MG

Начин на приложение:

PER OS

Вид предписание :

Required

Произведено от:

JANSSEN CILAG S.P.A., ITALY

Терапевтична група:

ABIRATERONE

Терапевтична област:

ABIRATERONE

Терапевтични показания:

Zytiga is a CYP17 inhibitor indicated:- in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.- for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

Дата Оторизация:

2017-04-30

Листовка

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed
with a doctor’s prescription only
Zytiga
®
250 mg
Tablets
Active ingredient and its quantity
Abiraterone acetate 250 mg, equivalent to 223 mg of abiraterone.
Inactive ingredients and allergens in the preparation – see section
2 “Important
information
about
some
of
the
ingredients
of
the
medicine” and section 6
“ F u r t h e r
Information”.
Read the 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 the treatment of 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 IS THE MEDICINE INTENDED FOR?
Zytiga 250 mg is a prescription medicine containing an active
ingredient called
abiraterone
acetate.
Zytiga
250 mg
is
a
CYP17
enzyme
inhibitor,
given
in
c o m b i n a t i o n
w i t h
p r e d n i s o n e
f o r
t h e
t r e a t m e n t
of:
•
metastatic castration-resistant prostate cancer.
•
adult males with newly diagnosed high-risk metastatic
hormone-sensitive
prostate cancer (mHSPC) in combination with androgen deprivation
therapy
(ADT).
Therapeutic group:
Specific inhibitor of the enzyme CYP17.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
•
If you are sensitive (allergic) to abiraterone acetate or to any of
the additional
ingredients contained in the medicine. For a list of the additional
ingredients,
see section 6 “Further Information”.
•
If you are a woman, and especially a pregnant woman. Zytiga 250 mg is
intended for use in males only.
•
If you suffer from severe liver damage.
•
In combination with Ra-223 (used to treat prostate cancer).
Do not take the medicine if any of the above apply to your condition.
If you are
not sure, consult with your doctor or pharmacist before taking the
medicine.
Special warnings regardi

Данни за продукта

דומע
1
ךותמ
22
Zytiga 250mg_PI_Apr2023_ref_EU SmPC_Jun2022
1.
NAME OF THE MEDICINAL PRODUCT
ZYTIGA 250 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of abiraterone acetate equivalent to 223
mg of abiraterone.
Excipients with known effect
Each tablet contains 198.65 mg of lactose monohydrate and 6.8 mg of
sodium.
For the full list of excipients, see section
7
.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed
with AA250 on one side.
4
INDICATIONS AND USAGE
Zytiga 250 mg
is
a CYP17 inhibitor
indicated in combination with prednisone for the treatment of
_ _
patients
with metastatic castration-resistant prostate cancer.
The treatment of newly diagnosed high risk metastatic hormone
sensitive prostate cancer
(mHSPC) in adult men in combination with androgen deprivation therapy
(ADT).
5
DOSAGE AND ADMINISTRATION
5.1 recommended dose for metastatic CRPC
The recommended dose of ZYTIGA 250 mg is 1,
000 mg (four
250mg
tablets)
administered orally once
daily
in combination
with
prednisone 5 mg administered orally
TWICE
daily.
5.2 recommended dose for metastatic High-risk mHSPC
The recommended dose of Zytiga 250 mg is 1,000 mg (four 250mg tablets)
administered orally once daily in
combination with prednisone 5mg administered orally
ONCE
daily...
5.3 important administration instructions
Patients receiving Zytiga 250 mg should also receive a
gonadotropin-releasing hormone (GnRH) analog
concurrently or should have had bilateral orchiectomy.
ZYTIGA 250 MG must be taken on an empty stomach. No food should be
consumed for at least two hours before
the dose of ZYTIGA 250 MG is taken and for at least one hour after the
dose of ZYTIGA 250 MG is taken
_[see _
_Method of administration (5.5)]._
The tablets should be swallowed whole
with water. Do not crush or chew tablets.
Serum transaminases should be measured prior to starting treatment
with Zytiga 250 mg, every two weeks for the
first three months of treatment and monthly thereafter. B