Tibsovo

Country: European Union

Language: Romanian

Source: EMA (European Medicines Agency)

Buy It Now

Download Patient Information leaflet (PIL)
01-01-1970
Download Summary of Product characteristics (SPC)
01-01-1970
Download Public Assessment Report (PAR)
01-01-1970

Active ingredient:

Ivosidenib

Available from:

Les Laboratoires Servier

ATC code:

L01XX62

INN (International Name):

ivosidenib

Therapeutic group:

Agenți antineoplazici

Therapeutic area:

Leukemia, Myeloid, Acute; Cholangiocarcinoma

Therapeutic indications:

Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.

Authorization status:

Autorizat

Authorization date:

2023-05-04

Patient Information leaflet

                                35
B. PROSPECTUL
36 PROSPECT: INFORMAŢII PENTRU PACIENT
TIBSOVO 250 MG COMPRIMATE FILMATE
ivosidenib
Acest medicament face obiectul unei monitorizări suplimentare. Acest
lucru va permite
identificarea rapidă de noi informații referitoare la siguranță.
Puteți să fiți de ajutor raportând orice
reacții adverse pe care le puteți avea. Vezi ultima parte de la pct.
4 pentru modul de raportare a
reacțiilor adverse.
CITIŢI CU ATENŢIE ŞI ÎN ÎNTREGIME ACEST PROSPECT ÎNAINTE DE A
ÎNCEPE SĂ LUAŢI ACEST MEDICAMENT
DEOARECE CONŢINE INFORMAŢII IMPORTANTE PENTRU DUMNEAVOASTRĂ.
-
Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.
-
Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului
dumneavoastră sau asistentei
medicale.
_ _
-
Acest medicament a fost prescris numai pentru dumneavoastră. Nu
trebuie să-l daţi altor
persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală
ca dumneavoastră.
_ _
-
Dacă manifestaţi orice reacţii adverse, adresaţi-vă medicului
dumneavoastră sau asistentei
medicale.
_ _
Acestea includ orice posibile reacţii adverse nemenţionate în acest
prospect. Vezi
pct. 4.
_ _
CE GĂSIŢI ÎN ACEST PROSPECT
1.
Ce este Tibsovo
şi pentru ce se utilizează
2.
Ce trebuie să ştiţi înainte să luaţi Tibsovo
3.
Cum să luaţi Tibsovo
4.
Reacţii adverse posibile
5.
Cum se păstrează Tibsovo
6.
Conţinutul ambalajului şi alte informaţii
1.
CE ESTE TIBSOVO ŞI PENTRU CE SE UTILIZEAZĂ
CE ESTE TIBSOVO
Tibsovo conține substanța activă ivosidenib. Este un medicament
utilizat pentru a trata anumite tipuri
de cancer care conțin o genă mutantă (modificată) care produce o
proteină cunoscută sub numele de
IDH1 și care joacă un rol important în producerea de energie pentru
celule. Când gena IDH1 este
mutantă, proteina IDH1 este modificată și nu funcționează corect,
iar acest lucru are ca rezultat
modificări ale celulei care pot duce la dezvoltarea cancerului.
Tibsovo blochează forma mutantă a
proteinei IDH1 și ajută
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
2
Acest medicament face obiectul unei monitorizări suplimentare. Acest
lucru va permite
identificarea rapidă de noi informaţii referitoare la siguranţă.
Profesioniştii din domeniul sănătăţii sunt
rugaţi să raporteze orice reacţii adverse suspectate. Vezi pct. 4.8
pentru modul de raportare a reacţiilor
adverse.
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
Tibsovo 250 mg comprimate filmate
2.
COMPOZIȚIA CALITATIVĂ ȘI CANTITATIVĂ
Fiecare comprimat filmat conține ivosidenib 250 mg.
Excipient cu efect cunoscut
Fiecare comprimat filmat conține lactoză monohidrat echivalent cu
lactoză 9,5 mg (vezi pct. 4.4).
Pentru lista tuturor excipienţilor, vezi pct. 6.1.
3.
FORMA FARMACEUTICĂ
Comprimat filmat (comprimat).
Comprimat filmat oval, de culoare albastră, cu diametru de 18 mm,
marcat cu “IVO” pe o față și cu
“250” pe cealaltă față.
4.
DATE CLINICE
4.1
INDICAȚII TERAPEUTICE
Tibsovo administrat în asociere cu azacitidina este indicat pentru
tratamentul pacienților adulți cu
leucemie acută mieloidă (LAM) nou diagnosticată, cu o mutație
izocitrat dehidrogenază-1 (IDH1)
R132, care nu sunt eligibili pentru a primi chimioterapie de inducție
standard (vezi pct. 5.1).
Tibsovo administrat în monoterapie este indicat pentru tratamentul
pacienților adulți cu
colangiocarcinom local avansat sau metastatic, cu o mutație IDH1
R132, care au primit anterior cel
puțin o linie de tratament sistemic (vezi pct. 5.1).
4.2
DOZE ȘI MOD DE ADMINISTRARE
Tratamentul trebuie inițiat sub supravegherea unui medic cu
experienţă în utilizarea medicamentelor
antineoplazice.
Înainte de a lua Tibsovo, pacienții trebuie să aibă confirmarea
unei mutații IDH1 R132 folosind un test
de diagnostic adecvat.
Doze
_Leucemie acută mieloidă _
Doza recomandată este de 500 mg ivosidenib (2 comprimate x 250 mg)
administrată oral, o dată pe zi.
Tratamentul cu ivosidenib trebuie început în Ciclul 1 Ziua 1 în
asociere cu azacitidină în doza de
75 mg/m
2
sup
                                
                                Read the complete document

Similar products

Active ingredient Ivosidenib

Ivosidenib

ATC code L01XX62

L01XX62

Marketed by Les Laboratoires Servier

Les Laboratoires Servier

INN (International Name) ivosidenib

ivosidenib

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Danish 01-01-1970
Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Estonian 01-01-1970
Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
Summary of Product characteristics Summary of Product characteristics English 01-01-1970
Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 01-01-1970
Patient Information leaflet Patient Information leaflet Italian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 01-01-1970
Patient Information leaflet Patient Information leaflet Latvian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Latvian 01-01-1970
Public Assessment Report Public Assessment Report Latvian 01-01-1970
Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
Summary of Product characteristics Summary of Product characteristics Dutch 01-01-1970
Public Assessment Report Public Assessment Report Dutch 01-01-1970
Patient Information leaflet Patient Information leaflet Polish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Polish 01-01-1970
Public Assessment Report Public Assessment Report Polish 01-01-1970
Patient Information leaflet Patient Information leaflet Portuguese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Portuguese 01-01-1970
Public Assessment Report Public Assessment Report Portuguese 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovak 01-01-1970
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovenian 01-01-1970
Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Swedish 01-01-1970
Public Assessment Report Public Assessment Report Swedish 01-01-1970
Patient Information leaflet Patient Information leaflet Norwegian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Norwegian 01-01-1970
Patient Information leaflet Patient Information leaflet Icelandic 01-01-1970
Summary of Product characteristics Summary of Product characteristics Icelandic 01-01-1970
Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Croatian 01-01-1970
Public Assessment Report Public Assessment Report Croatian 01-01-1970

Search alerts related to this product

Alerts Tibsovo Ivosidenib

Tibsovo Ivosidenib

View documents history

Documents history Documents history

Tibsovo