Pemetrexed Sandoz 25 mg/ml concentrate for solution for infusion - 20ml vial

País: Malta

Língua: inglês

Origem: Medicines Authority

Disponível em:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

Código ATC:

L01BA04

DCI (Denominação Comum Internacional):

PEMETREXED 25 mg/ml

Forma farmacêutica:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composição:

PEMETREXED 25 mg/ml

Tipo de prescrição:

POM

Área terapêutica:

ANTINEOPLASTIC AGENTS

Resumo do produto:

Licence number in the source country: NOT APPLICAPABLE

Status de autorização:

Authorised

Data de autorização:

2023-01-26

Folheto informativo - Bula

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED SANDOZ 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 or pharmacist.
-
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. 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 are given
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.
This medicinal product is for adults use only.
Page 2 of 12
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PEMETREXED SANDOZ
_ _
DO NOT USE PEMETREXED SANDOZ
-
if you are allergic to pemetrexed or any of the other ingredients of
this medicine (l

Características técnicas

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Sandoz 25 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml concentrate for solution for infusion contains 25 mg
pemetrexed (as pemetrexed disodium
hemipentahydrate).
Each vial with 4 ml contains 100 mg of pemetrexed (as pemetrexed
disodium hemipentahydrate).
Each vial with 20 ml contains 500 mg of pemetrexed (as pemetrexed
disodium hemipentahydrate).
Each vial with 40 ml contains 1000 mg of pemetrexed (as pemetrexed
disodium hemipentahydrate).
Excipient with known effect
Each ml concentrate for solution for infusion contains 2.78 mg (0.12
mmol) sodium.
Each ml concentrate for solution for infusion contains 50 mg propylene
glycol.
Each vial with 4 ml contains 11.12 mg (0.5 mmol) sodium, equivalent to
0.6% of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
Each vial with 4 ml contains 200 mg propylene glycol.
Each vial with 20 ml contains 55.6 mg (2.4 mmol) sodium, equivalent to
3% of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
Each vial with 20 ml contains 1000 mg propylene glycol.
Each vial with 40 ml contains 111.2 mg (4.8 mmol) sodium, equivalent
to 6% of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
Each vial with 40 ml contains 2000 mg propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to yellow or green - yellow solution.
Solution practically free of particles.
The pH of the concentrate is 8.0 – 9.0
Page 2 of 23
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 metas