PEMETREXED SANDOZ 100

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PEMETREXED AS DISODIUM

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L01BA04

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

PEMETREXED AS DISODIUM 100 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

GLAND PHARMA LIMITED , INDIA

Therapeutic area:

PEMETREXED

Therapeutic indications:

Pemetrexed Sandoz 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. Pemetrexed Sandoz 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 Sandoz 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.Pemetrexed Sandoz 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.

Authorization date:

2018-04-22

Patient Information leaflet

Novartis Israel Ltd
36 Shaham St., Kiryat Matalon, Petach-Tikva
P.O.B 7759, Petach Tikva 4951729, Israel
Tel: [phone] Fax: [phone]
.מ"עב לארשי סיטרבונ
'חר
םחש
36
חתפ ןולטמ תיירק
-
הוקת
.ד.ת
7759
חתפ
-
הוקת
4951729
:ןופלט
03-9201111
:סקפ
03-9229244
אפור
/
ה
,
חקור
/
ת
דבכנ
/
ה
, :ןודנה
אפורל ןולע ןוכדע לע העדוה
PEMETREXED SANDOZ
® 100MG, 500MG, 1000MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ונא
םישקבמ
עידוהל
ך
יכ
ולעה
אפורל ן
לש
רישכתה
םי
ןודנבש
ילויב ןכדוע
2018
.
®
Pemetrexed Sandoz
ל הוותמ
תויצקידניא
תואבה
:
MALIGNANT PLEURAL MESOTHELIOMA
Pemetrexed Sandoz 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 Sandoz 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 Sandoz 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 Sandoz 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.
ביכרמ
ליעפ
:
pemetrexed disodium
ידומעב
םיאבה ם
יתועמשמ יוניש וא הרמחה הווהמ רשא יוניש
השענ םהב םיפיעס םינייוצמ
.
עב ןייעל שי ,ףסונ עדימל
ןול
אפורל
ףרוצמה
יפכ
רשואש
לע
ידי
דרשמ
תואירבה
.
ןולעה
חלשנ ןכדועמה
םוסרפל
ר�

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Sandoz
®
100 mg powder for concentrate for solution for infusion
Pemetrexed Sandoz
®
500 mg powder for concentrate for solution for infusion
Pemetrexed Sandoz
®
1000 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemetrexed Sandoz 100 mg powder for concentrate for solution for
infusion
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Excipient with known effect
Each vial contains approximately 11 mg sodium.
Pemetrexed Sandoz 500 mg powder for concentrate for solution for
infusion
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Excipient with known effect
Each vial contains approximately 54 mg sodium.
Pemetrexed Sandoz 1000 mg powder for concentrate for solution for
infusion
Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Excipient 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 off-white or pale yellow lyophilised powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
Pemetrexed Sandoz 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 Sandoz 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 Sandoz 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 chem