Pemetrexed Pfizer (previously Pemetrexed Hospira)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pemetrexed disodium, pemetrexed disodium hemipentahydrate

Διαθέσιμο από:

Pfizer Europe MA EEIG

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

2015-11-19

Φύλλο οδηγιών χρήσης

59
B. PACKAGE LEAFLET
60
Package leaflet: Information for the user
Pemetrexed Pfizer 100 mg powder for concentrate for solution for
infusion
Pemetrexed Pfizer 500 mg powder for concentrate for solution for
infusion
Pemetrexed Pfizer 1,000 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 any further questions, ask your doctor or pharmacist or
nurse.
-
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 Pfizer is and what it is used for
2.
What you need to know before you use Pemetrexed Pfizer
3.
How to use Pemetrexed Pfizer
4.
Possible side effects
5.
How to store Pemetrexed Pfizer
6.
Contents of the pack and other information
1.
What Pemetrexed Pfizer is and what it is used for
Pemetrexed Pfizer is a medicine used in the treatment of cancer.
Pemetrexed Pfizer 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 Pfizer is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed Pfizer 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 Pfizer 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 Pfizer
Do not use Pemetrexed Pfizer
-
if you are allergic (hypersensitive) to pemetrexed or any of the other
ingredients of this
medicine (listed in section

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Pfizer 100 mg powder for concentrate for solution for
infusion
Pemetrexed Pfizer 500 mg powder for concentrate for solution for
infusion
Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed Pfizer 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 vial contains approximately 11 mg sodium.
Pemetrexed Pfizer 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 vial contains approximately 54 mg sodium.
Pemetrexed Pfizer 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 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 either light yellow or green-yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Malignant pleural mesothelioma
Pemetrexed Pfizer in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
3
Non-small cell lung cancer
Pemetrexed Pfizer 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 Pfizer 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 pr