Teysuno
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-01-2024
Charakterystyka produktu
(SPC)
18-01-2024
Sprawozdanie z oceny publicznego
(PAR)
28-02-2022
Składnik aktywny:
tegafur, gimeracil, oteracil
Dostępny od:
Nordic Group B.V.
Kod ATC:
L01BC53
INN (International Nazwa):
tegafur, gimeracil, oteracil
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Stomach Neoplasms
Wskazania:
Teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).- as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.
Podsumowanie produktu:
Revision: 21
Status autoryzacji:
Authorised
Data autoryzacji:
2011-03-14
Ulotka dla pacjenta
62
B.
PACKAGE LEAFLET
63
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEYSUNO 15 MG/4.35 MG/11.8 MG HARD CAPSULES
tegafur/gimeracil/oteracil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible any side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Teysuno is and what it is used for
2.
What you need to know before you take Teysuno
3.
How to take Teysuno
4.
Possible side effects
5.
How to store Teysuno
6.
Contents of the pack and other information
1.
WHAT IS TEYSUNO AND WHAT IS IT USED FOR
Teysuno contains the active substances tegafur gimeracil and oteracil.
Teysuno belongs to the fluoropyrimidine class of medicines known as
“antineoplastic agents” which
stop the growth of cancer cells.
Teysuno is prescribed by doctors for:
-
The treatment of adults with advanced stomach (gastric) cancer and is
taken with cisplatin,
another anti-cancer medicine.
-
The treatment of cancer of the large intestines and rectum which has
spread (metastasized)
and where it is not possible to continue with another fluoropyrimidine
(anti-cancer treatments
from the same group of medicines as Teysuno) due to side effects on
the skin of hands or feet
(hand-foot syndrome) or on the heart. In these patients, Teysuno is
used alone or in
combination with other anticancer medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEYSUNO
DO NOT TAKE TEYSUNO IF YOU:
-
are allergic to tegafur, gimeracil, oteracil or any of the other
ingredients of this medicine (listed
in section 6).
-
are taking other fluoropyrimidine anti-cancer medicine such as
fluorouracil and capecitabine, or
have had severe and unexpected reac
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8
mg oteracil (as
monopotassium).
Excipient with known effect
Each hard capsule contains 70.2 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
The capsule has an opaque white body and opaque brown cap imprinted
“TC448” in grey.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teysuno is indicated in adults:
-
for the treatment of advanced gastric cancer when given in combination
with cisplatin (see section
5.1).
-
as monotherapy or in combination with oxaliplatin or irinotecan, with
or without bevacizumab, for
the treatment of patients with metastatic colorectal cancer for whom
it is not possible to continue
treatment with another fluoropyrimidine due to hand-foot syndrome or
cardiovascular toxicity that
developed in the adjuvant or metastatic setting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Teysuno should only be prescribed by a qualified physician experienced
in treating cancer patients
with anti-neoplastic medicinal products.
Patients should be provided with outpatient prescriptions for
anti-emetic and anti-diarrhoeal medicinal
products.
The patient's BSA must be recalculated and the Teysuno dose adjusted
accordingly if a patient’s
weight increases or decreases by ≥10% from the one used for the
previous calculation of BSA and the
change is clearly not related to fluid retention.
Posology
_Advanced gastric cancer when given in combination with cisplatin _
The recommended standard dose of Teysuno when administered in
combination with cisplatin is
25 mg/m
2
(expressed as tegafur content) twice daily, morning and evening, for
21 consecutive days
followed by 7 days rest (1 treatment cycle). This treatment cycle is
repeated every 4 weeks.
The standard and reduced Teysuno and cisplatin doses and calcula
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