Pemetrexed Krka

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pemetrexed disodium

Διαθέσιμο από:

KRKA d.d.

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 Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka 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 Krka 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 Krka 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: 6

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-05-22

Φύλλο οδηγιών χρήσης

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED KRKA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED KRKA 500 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 any 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 Krka is and what it is used for
2.
What you need to know before you use Pemetrexed Krka
3.
How to use Pemetrexed Krka
4.
Possible side effects
5.
How to store Pemetrexed Krka
6.
Contents of the pack and other information
1.
WHAT PEMETREXED KRKA IS AND WHAT IT IS USED FOR
Pemetrexed Krka is a medicine used in the treatment of cancer.
Pemetrexed Krka 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 Krka is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed Krka 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 Krka 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 KRKA
DO NOT USE PEMETREXED KRKA
-
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
Pemetrexed Krka.
-
if you have recently received or

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Krka 100 mg powder for concentrate for solution for
infusion
Pemetrexed Krka 500 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed Krka 100 mg powder for concentrate for solution for
infusion
Each vial contains 100 mg pemetrexed (as pemetrexed disodium
hemipentahydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml
pemetrexed.
_Excipient with known effect_
Each vial contains approximately 11 mg (0.48 mmol) sodium.
Pemetrexed Krka 500 mg powder for concentrate for solution for
infusion
Each vial contains 500 mg pemetrexed (as pemetrexed disodium
hemipentahydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml
pemetrexed.
_Excipient with known effect_
Each vial contains approximately 54 mg (2.35 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to either light yellow or green yellow lyophilized cake or
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Krka in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Krka 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 Krka 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 Krka is indicated as monotherapy for the second-line
treatment of patients with locally
advanced or metastat