PEME-SOL 25 MGML

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

PEMETREXED AS DIACID MONOHYDRATE

Disponível em:

TEVA ISRAEL LTD

Código ATC:

L01BA04

Forma farmacêutica:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composição:

PEMETREXED AS DIACID MONOHYDRATE 25 MG / 1 ML

Via de administração:

I.V

Tipo de prescrição:

Required

Fabricado por:

TEVA ISRAEL LTD, ISRAEL

Área terapêutica:

PEMETREXED

Indicações terapêuticas:

Peme-Sol 25mg/ml in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. Peme-Sol 25mg/ml 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. Peme-Sol 25mg/ml 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. Peme-Sol 25mg/ml 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.

Data de autorização:

2022-08-17

Folheto informativo - Bula

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
PEME SOL 25 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
COMPOSITION:
Each 1 ml contains: 25 mg pemetrexed (as diacid monohydrate)
A 4 ml vial contains 100 mg pemetrexed diacid monohydrate
A 20 ml vial contains 500 mg pemetrexed diacid monohydrate
A 34 ml vial contains 850 mg pemetrexed diacid monohydrate
A 40 ml vial contains 1,000 mg pemetrexed diacid monohydrate
Further
dilution
by
a
healthcare
professional
is
required
before
administration.
FOR
INFORMATION
ABOUT
INACTIVE
INGREDIENTS
see
section
6
–
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information about the medicine. If you have
any other questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for treatment of your illness. Do
not pass it on to others. It may harm them even if it seems to you
that
their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
PEME SOL is a medicine used for the treatment of cancer.
PEME SOL in combination with cisplatin is indicated for the treatment
of patients with malignant pleural mesothelioma whose disease is
unresectable or who are otherwise not candidates for any other
curative surgery.
PEME SOL 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.
PEME SOL 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.
PEME SOL is indicated as monotherapy for the maintenance treatment
of patients with 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 chemo