Pemetrexed Baxter

Country: European Union

Language: Slovak

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
19-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
19-01-2023
Public Assessment Report Public Assessment Report (PAR)
19-01-2023

Active ingredient:

pemetrexed disodium heptahydrate

Available from:

Baxter Holding B.V.

ATC code:

L01BA04

INN (International Name):

pemetrexed

Therapeutic group:

Antineoplastické činidlá

Therapeutic area:

Carcinoma, Non-Small-Cell Lung; Mesothelioma

Therapeutic indications:

Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancerPemetrexed Baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. Pemetrexed Baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. Pemetrexed Baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.

Authorization status:

oprávnený

Authorization date:

2022-12-09

Patient Information leaflet

                                30
B. PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA
31
PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA
PEMETREXED BAXTER 100 MG PRÁŠOK NA KONCENTRÁT NA INFÚZNY ROZTOK
PEMETREXED BAXTER 500 MG PRÁŠOK NA KONCENTRÁT NA INFÚZNY ROZTOK
pemetrexed
POZORNE SI PREČÍTAJTE CELÚ PÍSOMNÚ INFORMÁCIU PREDTÝM, AKO
ZAČNETE UŽÍVAŤ TENTO LIEK.
-
Túto písomnú informáciu si uschovajte. Možno bude potrebné, aby
ste si ju znovu prečítali.
-
Ak máte akékoľvek ďalšie otázky, obráťte sa na svojho lekára
alebo lekárnika.
-
Ak sa u vás vyskytne akýkoľvek vedľajší účinok, obráťte sa
na svojho lekára alebo lekárnika.
To sa týka aj akýchkoľvek vedľajších účinkov, ktoré nie sú
uvedené v tejto písomnej informácii
pre používateľa. Pozri časť 4.
V TEJTO PÍSOMNEJ INFORMÁCII SA DOZVIETE
1.
Čo je Pemetrexed Baxter a na čo sa používa
2.
Čo potrebujete vedieť predtým, ako použijete liek Pemetrexed
Baxter
3.
Ako používať liek Pemetrexed Baxter
4.
Možné vedľajšie účinky
5.
Ako uchovávať liek Pemetrexed Baxter
6.
Obsah balenia a ďalšie informácie
1.
ČO JE PEMETREXED BAXTER A NA ČO SA POUŽÍVA
Pemetrexed Baxter je liek určený na liečbu zhubných nádorov.
Pemetrexed Baxter sa podáva v kombinácii s cisplatinou, ďalším
protirakovinovým liekom, na liečbu
malígneho mezoteliómu pleury, typu rakoviny, ktorý postihuje
výstelku pľúc, pacientom, ktorí
predtým nedostávali chemoterapiu.
Pemetrexed Baxter sa tiež podáva v kombinácii s cisplatinou na
počiatočnú liečbu pacientov s
pokročilým štádiom rakoviny pľúc.
Pemetrexed Baxter vám môžu predpísať aj ak máte rakovinu pľúc
v pokročilom štádiu a vaše
ochorenie reagovalo na liečbu alebo ostalo po počiatočnej
chemoterapii prevažne nezmenené.
Pemetrexed Baxter je tiež určený na liečbu pacientov s
pokročilým štádiom rakoviny pľúc, u ktorých
dôjde ku zhoršeniu ochorenia po tom, čo bola použitá iná
úvodná chemoterapia.
2.
ČO POTREBUJETE VEDIEŤ PREDTÝM, AKO POUŽIJETE LIEK P
                                
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Summary of Product characteristics

                                1
PRÍLOHA I
SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
2
1.
NÁZOV LIEKU
Pemetrexed Baxter 100 mg prášok na koncentrát na infúzny roztok
Pemetrexed Baxter 500 mg prášok na koncentrát na infúzny roztok
2.
KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE
Pemetrexed Baxter 100 mg prášok na koncentrát na infúzny roztok
Každá injekčná liekovka obsahuje 100 mg pemetrexedu (ako disodnú
soľ pemetrexedu).
_Pomocná látka so známym účinkom _
Každá injekčná liekovka obsahuje približne 11 mg sodíka.
Pemetrexed Baxter 500 mg prášok na koncentrát na infúzny roztok
Každá injekčná liekovka obsahuje 500 mg pemetrexedu (ako disodnú
soľ pemetrexedu).
_Pomocná látka so známym účinkom _
Každá injekčná liekovka obsahuje približne 54 mg sodíka.
Po rekonštitúcii (pozri časť 6.6) obsahuje každá injekčná
liekovka 25 mg/ml pemetrexedu.
Úplný zoznam pomocných látok, pozri časť 6.1.
3.
LIEKOVÁ FORMA
Prášok na koncentrát na infúzny roztok. (Prášok na koncentrát)
Biely až svetložltý alebo zelenožltý lyofilizovaný prášok.
4.
KLINICKÉ ÚDAJE
4.1
TERAPEUTICKÉ INDIKÁCIE
Malígny mezotelióm pleury
Pemetrexed Baxter v kombinácii s cisplatinou je indikovaný na
liečbu pacientov bez predchádzajúcej
chemoterapie s neresekovateľným malígnym mezoteliómom pleury.
Nemalobunkový karcinóm pľúc
Pemetrexed Baxter v kombinácii s cisplatinou je indikovaný ako
liečba prvej línie pacientov s lokálne
pokročilým alebo metastatickým nemalobunkovým karcinómom pľúc
okrem prevažne skvamóznej
bunkovej histológie (pozri časť 5.1).
Pemetrexed Baxter je indikovaný v monoterapii na udržiavaciu liečbu
lokálne pokročilého alebo
metastázujúceho nemalobunkového karcinómu pľúc, inej ako
prevažne skvamóznej bunkovej
histológie u pacientov, u ktorých po chemoterapii založenej na
platine nedošlo k bezprostrednej
progresii ochorenia (pozri časť 5.1).
Pemetrexed Baxter je indikovaný v monoterapii na liečbu druhej
línie pacientov s lokálne pokročilým
aleb
                                
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Active ingredient pemetrexed disodium heptahydrate

pemetrexed disodium heptahydrate

ATC code L01BA04

L01BA04

Marketed by Baxter Holding B.V.

Baxter Holding B.V.

INN (International Name) pemetrexed

pemetrexed

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Patient Information leaflet Patient Information leaflet Bulgarian 19-01-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 19-01-2023
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