PEMETREXED TEVA 100 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PEMETREXED

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

L01BA04

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

PEMETREXED 100 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic area:

PEMETREXED

Therapeutic indications:

Malignant pleural mesothelioma :Pemetrexed Teva 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. Non-small cell lung cancer: Pemetrexed Teva 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 Teva 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. Pemetrexed Teva 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.

Authorization date:

2021-05-31

Patient Information leaflet

93.132.309-B
)بلقلا تلاضع خض ةوق يف رثؤت ةلاح( بلقلا
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مضهلا رسع
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نطبلا يف ملأ
مدلا يف دبكلا اهجتني يتلا داوملا ةيمك
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Summary of Product characteristics

Page 1 of 23
Pemetrexed-Teva-100mg-500mg-1000mg-powder-for-sol-for-inj-SPC-notif-KK-07-2022
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pemetrexed Teva 100 mg powder for concentrate for solution for
infusion
Pemetrexed Teva 500 mg powder for concentrate for solution for
infusion
Pemetrexed Teva 1000 mg powder for concentrate for solution for
infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PEMETREXED TEVA 100 MG powder for concentrate for solution for
infusion.
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Excipients with known effect:
Each vial contains approximately 11 mg sodium.
PEMETREXED TEVA 500 MG powder for concentrate for solution for
infusion.
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Excipients with known effect:
Each vial contains approximately 54 mg sodium.
PEMETREXED TEVA 1000 MG powder for concentrate for solution for
infusion.
Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Excipients with known effect:
Each vial contains approximately 109 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 lyophilised powder.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Teva in combination with cisplatin is indicated for the
treatment of patients
Page 2 of 23
Pemetrexed-Teva-100mg-500mg-1000mg-powder-for-sol-for-inj-SPC-notif-KK-07-2022
with malignant pleural mesothelioma whose disease is unresectable or
who are otherwise
not candidates for curatible surgery.
Non-small cell lung cancer:
Pemetrexed Teva 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 Teva is indicated as monotherapy for the maintenance
treatment o