Everolimus Teva 2.5 mg Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Everolimus

Dostupné s:

Teva B.V.

ATC kód:

L01XE; L01XE10

INN (Mezinárodní Name):

Everolimus

Dávkování:

2.5 milligram(s)

Léková forma:

Tablet

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Protein kinase inhibitors; everolimus

Stav Autorizace:

Not marketed

Datum autorizace:

2017-06-30

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EVEROLIMUS TEVA 2.5 MG TABLETS
EVEROLIMUS TEVA 5 MG TABLETS
EVEROLIMUS TEVA 10 MG TABLETS_ _
Everolimus
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Everolimus Teva is and what it is used for
2.
What you need to know before you take Everolimus Teva
3.
How to take Everolimus Teva
4.
Possible side effects
5.
How to store Everolimus Teva
6.
Contents of the pack and other information
1.
WHAT EVEROLIMUS TEVA IS AND WHAT IT IS USED FOR
Everolimus Teva is an anticancer medicine containing the active
substance everolimus. Everolimus
reduces the blood supply to the tumour and slows down the growth and
spread of cancer cells.
Everolimus Teva is used to treat adult patients with:

ADVANCED TUMOURS called neuroendocrine tumours that originate from the
stomach, bowels,
lung.
It is given if the tumours are inoperable and do not overproduce
specific hormones or
other related natural substances.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVEROLIMUS TEVA
Everolimus Teva will only be prescribed for you by a doctor with
experience in cancer treatment.
Follow all the doctor’s instructions carefully. They may differ from
the general information contained
in this leaflet. If you have any questions about Everolimus Teva or
why it has been prescribed for you,
ask your doctor.
DO NOT TAKE EVEROLIMUS TEVA:

IF YOU ARE ALLERGIC to everolimus, to related substances such as
sirolimus or temsirolimus, or to
any of the other ingredients of this medicine (listed i

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Everolimus Teva 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg everolimus.
Excipient with known effect:
Each tablet contains 74 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, oblong, flat, bevelled edge tablets, approximately 10mm long
and 4mm wide, marked with “EV” on one side
and “2.5” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Neuroendocrine tumours of gastrointestinal or lung origin
Everolimus Teva is indicated for the treatment of unresectable or
metastatic, well-differentiated (Grade 1 or Grade 2)
non-functional neuroendocrine tumours of gastrointestinal or lung
origin in adults with progressive disease (see
sections 4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Everolimus Teva should be initiated and supervised by a
physician experienced in the use of anticancer
therapies.
Posology
For the different dose regimens, Everolimus Teva is available as 2.5
mg, 5 mg, 7.5 mg and 10 mg tablets.
The recommended dose is 10 mg everolimus once daily. Treatment should
continue as long as clinical benefit is
observed or until unacceptable toxicity occurs.
If a dose is missed, the patient should not take an additional dose,
but take the next prescribed dose as usual.
_Dose adjustment due to adverse reactions_
Management of severe and/or intolerable suspected adverse reactions
may require dose reduction and/or temporary
interruption of Everolimus Teva therapy. For adverse reactions of
Grade 1, dose adjustment is usually not required. If
dose reduction is required, the recommended dose is 5 mg daily and
must not be lower than 5 mg daily.
Table 1 summarises the dose adjustment recommendations for specific
adverse reactions (see also section 4.4).
TABLE 1
EVEROLIMUS TEVA DOSE ADJUSTMENT RECOMMENDATIONS
ADVERSE REACTION
SEVERITY
1
EVEROLIMUS TEVA DOSE ADJUSTMENT
H
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