Pemetrexed medac

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

pemetrexed

Dostupné z:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC kód:

L01BA04

INN (Medzinárodný Name):

pemetrexed

Terapeutické skupiny:

Folic acid analogues, Antineoplastic agents

Terapeutické oblasti:

Carcinoma, Non-Small-Cell Lung; Mesothelioma

Terapeutické indikácie:

Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac 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 medac 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 medac 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.,

Prehľad produktov:

Revision: 8

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2015-11-26

Príbalový leták

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED MEDAC 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED MEDAC 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED MEDAC 1,000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have further questions, 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 medac is and what it is used for
2.
What you need to know before you use Pemetrexed medac
3.
How to use Pemetrexed medac
4.
Possible side effects
5.
How to store Pemetrexed medac
6.
Contents of the pack and other information
1.
WHAT PEMETREXED MEDAC IS AND WHAT IS IT USED FOR
Pemetrexed medac is a medicine used in the treatment of cancer.
Pemetrexed medac 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 medac is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed 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 medac 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 MEDAC
DO NOT USE PEMETREXED MEDAC
−
if you are allergic to pemetrexed or any of the other ingredients of
this medicine (listed in
section 6).
−
if you are breast-feeding; you must discontinue

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed medac 100 mg powder for concentrate for solution for
infusion
Pemetrexed medac 500 mg powder for concentrate for solution for
infusion
Pemetrexed medac 1,000 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed medac 100 mg powder for concentrate for solution for
infusion
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium
hemipentahydrate).
_Excipient with known effect _
Each 100 mg vial contains approximately 11 mg sodium.
Pemetrexed medac 500 mg powder for concentrate for solution for
infusion
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium
hemipentahydrate).
_Excipient with known effect _
Each 500 mg vial contains approximately 54 mg sodium.
Pemetrexed medac 1,000 mg powder for concentrate for solution for
infusion
Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium
hemipentahydrate).
_Excipient with known effect _
Each 1,000 mg vial contains approximately 108 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 light yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed medac in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed medac 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 medac 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 immed