Pemetrexed Sandoz

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

pemetrexed disodium hemipentahydrate

MAH:

Sandoz GmbH

ATC_code:

L01BA04

INN:

pemetrexed

therapeutic_group:

Antineoplastic agents

therapeutic_area:

Carcinoma, Non-Small-Cell Lung; Mesothelioma

therapeutic_indication:

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

leaflet_short:

Revision: 7

authorization_status:

Authorised

authorization_date:

2015-09-18

PIL

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED SANDOZ 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED SANDOZ 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED SANDOZ 1000 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, please 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 Sandoz is and what it is used for
2.
What you need to know before you use Pemetrexed Sandoz
3.
How to use Pemetrexed Sandoz
4.
Possible side effects
5.
How to store Pemetrexed Sandoz
6.
Contents of the pack and other information
1.
WHAT PEMETREXED SANDOZ IS AND WHAT IT IS USED FOR
Pemetrexed Sandoz is a medicine used in the treatment of cancer.
Pemetrexed Sandoz 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 Sandoz is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed Sandoz 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 Sandoz 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 SANDOZ
_ _
DO NOT USE PEMETREXED SANDOZ:
-
if you are allergic (hypersensitive) to pemetrexed or any of the other
ingredients of this
medicine (listed in section 6).
-

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Sandoz 100 mg powder for concentrate for solution for
infusion
Pemetrexed Sandoz 500 mg powder for concentrate for solution for
infusion
Pemetrexed Sandoz 1000 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed Sandoz 100 mg powder for concentrate for solution for
infusion
One vial of powder contains 100 mg of pemetrexed (as disodium).
_Excipient with known effect _
One vial of powder contains approximately 11 mg of sodium.
Pemetrexed Sandoz 500 mg powder for concentrate for solution for
infusion
One vial of powder contains 500 mg of pemetrexed (as disodium).
_Excipient with known effect _
One vial of powder contains approximately 54 mg of sodium.
Pemetrexed Sandoz 1000 mg powder for concentrate for solution for
infusion
One vial of powder contains 1000 mg of pemetrexed (as disodium).
_Excipient with known effect _
One vial of powder contains approximately 108 mg of 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 off-white or pale yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Sandoz in combination with cisplatin is indicated for the
treatment of chemotherapy naive
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Sandoz 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 Sandoz 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 followin