Alimta
Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
Lietošanas instrukcija
(PIL)
03-05-2022
Produkta apraksts
(SPC)
03-05-2022
Publiskā novērtējuma ziņojums
(PAR)
09-12-2011
Aktīvā sastāvdaļa:
pemetrexed
Pieejams no:
Eli Lilly Nederland B.V.
ATĶ kods:
L01BA04
SNN (starptautisko nepatentēto nosaukumu):
pemetrexed
Ārstniecības grupa:
Antineoplastic agents
Ārstniecības joma:
Mesothelioma; Carcinoma, Non-Small-Cell Lung
Ārstēšanas norādes:
Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.Non-small-cell lung cancerAlimta 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.Alimta 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.Alimta 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.
Produktu pārskats:
Revision: 27
Autorizācija statuss:
Authorised
Autorizācija datums:
2004-09-20
Lietošanas instrukcija
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALIMTA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ALIMTA 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 ALIMTA is and what it is used for
2.
What you need to know before you use ALIMTA
3.
How to use ALIMTA
4.
Possible side effects
5.
How to store ALIMTA
6.
Contents of the pack and other information
1.
WHAT ALIMTA IS AND WHAT IT IS USED FOR
ALIMTA is a medicine used in the treatment of cancer.
ALIMTA 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.
ALIMTA is also given in combination with cisplatin for the initial
treatment of patients with
advanced stage of lung cancer.
Alimta 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.
ALIMTA 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 ALIMTA
DO NOT USE ALIMTA
-
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-feeding during
treatment with ALIMTA.
-
if you have recently received or are about to receive a vaccine
against yellow fever.
WARNINGS AND PRECAUTIONS
Talk to your doctor or hospital
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Produkta apraksts
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ALIMTA 100 mg powder for concentrate for solution for infusion
ALIMTA 500 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALIMTA 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.
ALIMTA 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
ALIMTA in combination with cisplatin is indicated for the treatment of
chemotherapy naïve patients
with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
ALIMTA 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).
ALIMTA 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).
ALIMTA 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).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ALIMTA must only be administered under the supervision of a physician
qualified i
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