PEMETREXED TARO 1000 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

PEMETREXED

Tillgänglig från:

TARO INTERNATIONAL LTD, ISRAEL

ATC-kod:

L01BA04

Läkemedelsform:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sammansättning:

PEMETREXED 1000 MG/VIAL

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

TARO INTERNATIONAL LTD, ISRAEL

Terapiområde:

PEMETREXED

Terapeutiska indikationer:

1.Pemetrexed Taro 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. 2.Pemetrexed Taro 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. 3.Pemetrexed Taro 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.4.Pemetrexed Taro 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.

Tillstånd datum:

2020-01-16

Bipacksedel

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
PEMETREXED TARO 100 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
PEMETREXED TARO 500 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
PEMETREXED TARO 1000 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ACTIVE INGREDIENT: pemetrexed.
PEMETREXED TARO
100 MG: Each vial contains 100 mg pemetrexed (as pemetrexed disodium
heptahydrate)
PEMETREXED TARO 500 MG: Each vial contains 500 mg pemetrexed (as
pemetrexed disodium
heptahydrate)
PEMETREXED TARO 1000 MG: Each vial contains 1000 mg pemetrexed (as
pemetrexed
disodium heptahydrate).
After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Further dilution by a
healthcare provider is required prior to administration.
Inactive ingredients and allergens: see section 2 under “Important
information about some of
this medicine’s ingredients” and section 6 “Additional
information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, please contact
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
PEMETREXED TARO is a medicine used to treat cancer.
PEMETREXED TARO 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 curative surgery.
PEMETREXED TARO 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 TARO is indicated as monotherapy for the second-line
treatment of patients with
locally advanced or metastatic

Produktens egenskaper

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1.
NAME OF THE MEDICINAL PRODUCT
PEMETREXED TARO 100 MG
powder for concentrate for solution for infusion
PEMETREXED TARO 500 MG
powder for concentrate for solution for infusion
PEMETREXED TARO 1000 MG
powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed Taro 100 mg powder for concentrate for solution for
infusion
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium
heptahydrate).
Excipients with known effect:
Each vial contains approximately 11 mg sodium.
Pemetrexed Taro 500 mg powder for solution for infusion
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium
heptahydrate).
Excipients with known effect:
Each vial contains approximately 54 mg sodium.
Pemetrexed Taro 1000 mg powder for solution for infusion
Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium
heptahydrate).
Excipients with known effect:
Each vial contains approximately 108 mg 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 either light yellow or green yellow lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Taro 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 curatable surgery.
Non-small cell lung cancer:
Pemetrexed Taro 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 Taro is indicated as monotherapy for the maintenance
treatment of locally
advanced or metastatic non-small cell lung cancer other than
predominantly squamous cell
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histology in patients whose disease has not progressed immediately
follow