Pemetrexed Lilly
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-11-2021
Charakterystyka produktu
(SPC)
26-11-2021
Sprawozdanie z oceny publicznego
(PAR)
26-11-2021
Składnik aktywny:
pemetrexed
Dostępny od:
Eli Lilly Netherlands
Kod ATC:
L01BA04
INN (International Nazwa):
pemetrexed
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Wskazania:
Malignant pleural mesotheliomaPemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Lilly 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.Pemetrexed Lilly 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.Pemetrexed Lilly 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.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2015-09-14
Ulotka dla pacjenta
31
B. PACKAGE LEAFLET
Medicinal product no longer authorised
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED LILLY 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED LILLY 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or pharmacist.
-
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 Pemetrexed Lilly is and what it is used for
2.
What you need to know before you use Pemetrexed Lilly
3.
How to use Pemetrexed Lilly
4.
Possible side effects
5.
How to store Pemetrexed Lilly
6.
Contents of the pack and other information
1.
WHAT PEMETREXED LILLY IS AND WHAT IT IS USED FOR
Pemetrexed Lilly is a medicine used in the treatment of cancer.
Pemetrexed Lilly is given in combination with cisplatin, another
anti-cancer medicine, as treatment for
malignant pleural mesothelioma, a form of cancer that affects the
lining of the lung, to patients who
have not received prior chemotherapy.
Pemetrexed Lilly is also given in combination with cisplatin for the
initial treatment of patients
with advanced stage of lung cancer.
Pemetrexed Lilly can be prescribed to you if you have lung cancer at
an advanced stage if your
disease has responded to treatment or it remains largely unchanged
after initial chemotherapy.
Pemetrexed Lilly is also a treatment for patients with advanced stage
of lung cancer whose disease has
progressed after other initial chemotherapy has been used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PEMETREXED LILLY
DO NOT USE PEMETREXED LILLY
-
if you are allergic (hypersensitive) to pemetrexed or any of the other
ingredients of this
medicine (listed in section 6).
-
if you are breast-feeding; you must discontinue breast-feed
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Lilly 100 mg powder for concentrate for solution for
infusion
Pemetrexed Lilly 500 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed Lilly 100 mg powder for concentrate for solution for
infusion
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
_Excipient with known effect _
Each vial contains approximately 11 mg sodium.
Pemetrexed Lilly 500 mg powder for concentrate for solution for
infusion
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
_Excipient with known effect _
Each vial contains approximately 54 mg sodium.
After reconstitution (see section 6.6), each vial contains 25 mg/mL of
pemetrexed.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to either light yellow or green-yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Lilly in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Lilly 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 5.1).
Pemetrexed Lilly 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
5.1).
Pemetrexed Lilly 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 5.1).
Medicinal produ
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