Armisarte (previously Pemetrexed Actavis)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pemetrexed diacid monohydrate

Διαθέσιμο από:

Actavis Group PTC ehf

Φαρμακολογική κατηγορία (ATC):

L01BA04

INN (Διεθνής Όνομα):

pemetrexed

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Carcinoma, Non-Small-Cell Lung; Mesothelioma

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Revision: 14

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-01-18

Φύλλο οδηγιών χρήσης

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARMISARTE 25 MG/ML 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 any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Armisarte is and what it is used for
2.
What you need to know before you use Armisarte
3.
How to use Armisarte
4.
Possible side effects
5.
How to store Armisarte
6.
Contents of the pack and other information
1.
WHAT ARMISARTE IS AND WHAT IT IS USED FOR
Armisarte is a medicine used in the treatment of cancer. It contains
the active substance pemetrexed.
Pemetrexed belongs to a group of medicines known as folic acid
analogues and disrupts processes that
are essential for cells to divide.
Armisarte 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.
Armisarte is also given in combination with cisplatin for the initial
treatment of patients with advanced
stage of lung cancer.
Armisarte 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.
Armisarte 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 ARMISARTE
DO NOT USE ARMISARTE
-
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 breast-feeding during
treatment with Armisarte.
-
if yo

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Armisarte 25 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 25 mg pemetrexed (as pemetrexed
diacid).
Each vial of 4 ml concentrate contains 100 mg pemetrexed (as
pemetrexed diacid).
Each vial of 20 ml concentrate contains 500 mg pemetrexed (as
pemetrexed diacid).
Each vial of 34 ml concentrate contains 850 mg pemetrexed (as
pemetrexed diacid).
Each vial of 40 ml concentrate contains 1000 mg pemetrexed (as
pemetrexed diacid).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is clear, colourless to slightly yellowish or
yellow-greenish solution.
The pH is between 7.0 and 8.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed in combination with cisplatin is indicated for the
treatment of chemotherapy naïve patients
with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed 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 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 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Pemetrexed must only be administered under the supervision of a
physician qualified in the use of
anti-cancer chemotherapy.
3
_Pemetrexed in combination with cisplatin