Pemetrexed Accord

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

pemetrexed disodium hemipentahydrate

Saatavilla:

Accord Healthcare S.L.U.

ATC-koodi:

L01BA04

INN (Kansainvälinen yleisnimi):

pemetrexed

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Non-Small-Cell Lung; Mesothelioma

Käyttöaiheet:

Malignant pleural mesotheliomaPemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Accord 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 Accord 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 Accord 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.

Tuoteyhteenveto:

Revision: 10

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-01-18

Pakkausseloste

58
B. PACKAGE LEAFLET
59
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED ACCORD 25 MG/ML 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 any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Pemetrexed Accord is and what it is used for
2.
What you need to know before you use Pemetrexed Accord
3.
How to use Pemetrexed Accord
4.
Possible side effects
5.
How to store Pemetrexed Accord
6.
Contents of the pack and other information
1.
WHAT PEMETREXED ACCORD IS AND WHAT IT IS USED FOR
Pemetrexed Accord is a medicine used in the treatment of cancer.
Pemetrexed Accord 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 Accord is also given in combination with cisplatin for the
initial treatment of
patients with advanced stage of lung cancer.
Pemetrexed Accord 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 Accord 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 ACCORD
DO NOT USE PEMETREXED ACCORD
-
if you are allergic to pemetrexed or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are breast-feed

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains pemetrexed disodium hemipentahydrate
equivalent to 25 mg
pemetrexed.
One vial of 4 ml of concentrate contains pemetrexed disodium
hemipentahydrate equivalent to 100 mg
Pemetrexed.
One vial of 20 ml of concentrate contains pemetrexed disodium
hemipentahydrate equivalent to 500
mg pemetrexed.
One vial of 34 ml of concentrate contains pemetrexed disodium
hemipentahydrate equivalent to 850
mg pemetrexed.
One vial of 40 ml of concentrate contains pemetrexed disodium
hemipentahydrate equivalent to 1000
mg pemetrexed.
Excipient with known effect
Each ml of solution contains 8.4 mg (0.4mmol) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear, colourless to pale yellow solution.
pH is between 7.0 - 8.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Accord in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Accord 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 Accord 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 Accord 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).