GEFITINIB TEVA

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

GEFITINIB

Доступна з:

TEVA ISRAEL LTD

Код атс:

L01XX31

Фармацевтична форма:

FILM COATED TABLETS

Склад:

GEFITINIB 250 MG

Адміністрація маршрут:

PER OS

Тип рецепту:

Required

Виробник:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Терапевтична области:

GEFITINIB

Терапевтичні свідчення:

Gefitinib Teva is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK.

Дата Авторизація:

2020-08-09

інформаційний буклет

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a
doctor's prescription only
GEFITINIB TEVA
COATED TABLETS
250 mg
COMPOSITION
Each coated tablet contains:
Gefitinib 250 mg
For information regarding inactive
ingredients and allergens, see section
2 - “Important information about some
ingredients of the medicine” and section
6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE
USING THE MEDICINE.
This leaflet contains concise information
about the medicine. If you have additional
questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for
treatment of your illness. Do not pass it
on to others. It may harm them even if it
seems to you that their illness is similar.
The medicine is intended for adults over
18 years old.
1. WHAT IS THE MEDICINE INTENDED FOR?
THERAPEUTIC ACTIVITY
Gefitinib Teva is intended for treatment of
non-small cell lung cancer (NSCLC).
Gefitinib Teva is intended for treatment
of adult patients with locally advanced
or metastatic non-small cell lung cancer
(NSCLC), with activating mutations of
EGFR-TK.
THERAPEUTIC CLASS
Anti-cancer agents, EGFR (epidermal
growth factor receptor) inhibitor.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the
active ingredient, gefitinib, or to any
of the other ingredients this medicine
contains (see section 6 – “Additional
information”).
•
You are breastfeeding.
SPECIAL WARNINGS REGARDING THE USE OF
THE MEDICINE:
During treatment with this medicine, liver
function should be tested periodically.
BEFORE TREATMENT WITH GEFITINIB TEVA,
INFORM THE DOCTOR IF:
•
You suffered in the past from other lung
problems. Certain lung problems may
be aggravated during treatment with
Gefitinib Teva.
•
You suffered in the past from liver
problems.
CHILDREN AND ADOLESCENTS
Gefitinib Teva is not indicated for children
and adolescents under the age of 18.
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENT

Характеристики продукта

Gefitinib-Teva-Tab_SPC-new_Notification_10-2023
SUMMARY OF PRODUCT CHARACTERISTICS
Gefitinib Teva 250 mg film-coated tablets
1. NAME OF THE MEDICINAL PRODUCT
Gefitinib Teva 250 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of gefitinib.
Excipient(s) with known effect:
Each tablet contains 162.12 mg of lactose (monohydrate)
Each tablet contains 0.20 mg of sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
A light brown to brown, round, convex tablet, debossed with “250”
on one side of the tablet
and plain on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Gefitinib Teva is indicated for the treatment of adult patients with
locally advanced or
metastatic non-small cell lung cancer (NSCLC) with activating
mutations of EGFR-TK
(see section 4.4).
4.2 Posology and method of administration
Treatment with Gefitinib Teva should be initiated and supervised by a
physician experienced
in the use of anti-cancer therapies.
Posology
The recommended posology of Gefitinib Teva is one 250 mg tablet once a
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.
_ _
_Paediatric population _
The safety and efficacy of Gefitinib Teva in children and adolescents
aged less than 18 years
has not been established. There is no relevant use of gefitinib in the
paediatric population in
the indication of NSCLC.
_ _
_ _
Gefitinib-Teva-Tab_SPC-new_Notification_10-2023
_Hepatic impairment _
Patients with moderate to severe hepatic impairment (Child Pugh B or
C) due to cirrhosis
have increased plasma concentrations of gefitinib. These patients
should be closely
monitored for adverse events. Plasma concentrations were not increased
in patients with
elevated aspartate transaminase (AST), alkaline phosphatase or
bili