Pemetrexed Koanaa Pdr/Conc/Soln for Infus 100mg

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

PEMETREXED

Tilgængelig fra:

Koanaa Healthcare GmbH Fehrgasse 7, 2401, Fischamend,, Austria

ATC-kode:

L01BA04

INN (International Name):

PEMETREXED 100 mg

Lægemiddelform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sammensætning:

PEMETREXED 100 mg

Recept type:

POM

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Autorisation status:

Withdrawn

Autorisation dato:

2018-09-04

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE U
SER
PEMETREXED KOANAA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
PEMETREXED KOANAA 500 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 Koanaa is and what it is used for
2. What you need to know before you use Pemetrexed Koanaa
3. How to use Pemetrexed Koanaa
4. Possible side effects
5. How to store Pemetrexed Koanaa
6. Contents of the pack and other information
1.
WHAT PEMETREXED KOANAA IS AND WHAT IT IS USED FOR
Pemetrexed Koanaa is a medicine used in the treatment of cancer.
Pemetrexed Koanaa 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 Koanaa is also given in combination with cisplatin for the
initial treatment of patients
with advanced stage of lung cancer.
Pemetrexed Koanaa 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 Koanaa 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 KOANAA
DO NOT USE PEMETREXED KOANAA
−
if you are allergic (hypersensitive) 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
K

Produktets egenskaber

Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Koanaa 100 mg powder for concentrate for solution for
infusion
Pemetrexed Koanaa 500mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100mg vial contains 100mg of pemetrexed (as pemetrexed disodium).
Excipients with known effect: Each vial contains approximately 11mg
sodium.
Each 500mg vial contains 500mg of pemetrexed (as pemetrexed disodium).
Excipients with known effect: Each vial contains approximately 54mg
sodium.
After reconstitution with 4.2 ml of sterile sodium chloride (0.9%) to
the 100 mg vial,
the solution contains 25 mg/ml pemetrexed (as pemetrexed disodium).
After reconstitution with 20 ml of sterile sodium chloride (0.9%) to
the 500 mg vial,
the solution contains 25 mg/ml pemetrexed (as pemetrexed disodium).
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 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).
Page 2 of 30
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 histo