Pemetrexed Baxter

Country: European Union

Language: Croatian

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:

Antineoplastična sredstva

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:

odobren

Authorization date:

2022-12-09

Patient Information leaflet

                                31
B. UPUTA O LIJEKU
32
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
PEMETREKSED BAXTER 100 MG PRAŠAK ZA KONCENTRAT ZA OTOPINU ZA INFUZIJU
PEMETREKSED BAXTER 500 MG PRAŠAK ZA KONCENTRAT ZA OTOPINU ZA INFUZIJU
pemetreksed
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To uključuje
i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Pemetreksed Baxter i za što se koristi
2.
Što morate znati prije nego počnete primati lijek Pemetreksed Baxter
3.
Kako se primjenjuje Pemetreksed Baxter
4.
Moguće nuspojave
5.
Kako čuvati lijek Pemetreksed Baxter
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE PEMETREKSED BAXTER I ZA ŠTO SE KORISTI
Pemetreksed Baxter je lijek koji se koristi za liječenje raka.
Pemetreksed Baxter se primjenjuje u kombinaciji s cisplatinom, još
jednim protutumorskim lijekom,
za liječenje zloćudnog pleuralnog mezotelioma, oblika raka koji
zahvaća plućne ovojnice, u bolesnika
koji prethodno nisu primali kemoterapiju.
Pemetreksed Baxter se također primjenjuje u kombinaciji s cisplatinom
za početno liječenje bolesnika
s uznapredovalim stadijem raka pluća.
Pemetreksed Baxter Vam se može propisati ako imate rak pluća u
uznapredovaloj fazi i ako je Vaša
bolest reagirala na liječenje ili ostala uglavnom nepromijenjena
nakon početne kemoterapije.
Pemetreksed Baxter se također primjenjuje u bolesnika s
uznapredovalim rakom pluća u kojih je
bolest napredovala nakon primjene neke druge početne kemoterapije.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMATI LIJEK PEMETREKSED BAXTER
NEMOJTE PRIMATI LIJEK PEMETREKSED BAXTER
-
ako ste alergični (preosjetljivi) na pemetreksed ili neki drugi
sastojak ovog lijeka
(naveden u dijelu 6).
-
ako dojite; ti
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Pemetreksed Baxter 100 mg prašak za koncentrat za otopinu za infuziju
Pemetreksed Baxter 500 mg prašak za koncentrat za otopinu za infuziju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Pemetreksed Baxter 100 mg prašak za koncentrat za otopinu za infuziju
Jedna bočica sadrži 100 mg pemetrekseda (u obliku
pemetrekseddinatrija).
_Pomoćna tvar s poznatim učinkom _
Jedna bočica sadrži približno 11 mg natrija.
Pemetreksed Baxter 500 mg prašak za koncentrat za otopinu za infuziju
Jedna bočica sadrži 500 mg pemetrekseda (u obliku
pemetrekseddinatrija).
_Pomoćna tvar s poznatim učinkom _
Jedna bočica sadrži približno 54 mg natrija.
Nakon rekonstitucije (vidjeti dio 6.6), jedna bočica sadrži 25 mg/ml
pemetrekseda.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
Bijeli do svijetložuti ili zeleno-žuti liofilizirani prašak.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Maligni pleuralni mezoteliom
Pemetreksed Baxter je u kombinaciji s cisplatinom indiciran za
liječenje bolesnika s neoperabilnim
malignim pleuralnim mezoteliomom koji prethodno nisu primali
kemoterapiju.
Rak pluća nemalih stanica
Pemetreksed Baxter je u kombinaciji s cisplatinom indiciran u prvoj
liniji liječenja bolesnika s lokalno
uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg
histološki ne prevladavaju
skvamozne stanice (vidjeti dio 5.1).
Pemetreksed Baxter je indiciran kao monoterapija u terapiji
održavanja lokalno uznapredovalog ili
metastatskog raka pluća nemalih stanica kod kojeg histološki ne
prevladavaju skvamozne stanice u
bolesnika u kojih bolest nije napredovala neposredno nakon
kemoterapije na bazi platine (vidjeti
dio 5.1).
Pemetreksed Baxter je indiciran kao monoterapija u drugoj liniji
liječenja bolesnika s lokalno
uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg
histološki ne prevladavaju
skvamozne stanice (vidjeti dio 
                                
                                Read the complete document

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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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