Pemetrexed Rowex 25 mg/ml concentrate for solution for infusion

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Pemetrexed

Prieinama:

Rowex Ltd

ATC kodas:

L01BA04

INN (Tarptautinis Pavadinimas):

Pemetrexed

Dozė:

25 milligram(s)/millilitre

Vaisto forma:

Concentrate for solution for infusion

Gydymo sritis:

pemetrexed

Autorizacija statusas:

Marketed

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED ROWEX 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.
-
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 Rowex is and what it is used for
2.
What you need to know before you are given
Pemetrexed Rowex
3.
How to use Pemetrexed Rowex
4.
Possible side effects
5.
How to store Pemetrexed Rowex
6.
Contents of the pack and other information
1.
WHAT PEMETREXED ROWEX IS AND WHAT IT IS USED FOR
Pemetrexed Rowex is a medicine used in the treatment of cancer.
Pemetrexed Rowex 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 Rowex is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
Pemetrexed Rowex 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 Rowex 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PEMETREXED ROWEX
_ _
DO NOT USE PEMETREXED ROWEX
-
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
Rowex
-
if you have recently received or are about to receive a vaccine

Prekės savybės

Health Products Regulatory Authority
28 June 2023
CRN00DD4L
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Rowex 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
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Rowex in combination with cisplatin is indicated for the
treatment of chemotherapy naive patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Rowex in combination with cisplatin is indicated for the
first-line treatment of