PEMETREXED S.K. 500 MG

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

PEMETREXED AS DISODIUM HEMIPENTAHYDRATE

Prieinama:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC kodas:

L01BA04

Vaisto forma:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sudėtis:

PEMETREXED AS DISODIUM HEMIPENTAHYDRATE 500 MG

Vartojimo būdas:

I.V

Recepto tipas:

Required

Pagaminta:

THYMOORGAN PHARMAZIE GMBH, GERMANY

Gydymo sritis:

PEMETREXED

Terapinės indikacijos:

Pemetrexed S.K. 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 S.K. 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 S.K. 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 S.K. 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.

Leidimo data:

2021-10-31

Pakuotės lapelis

K.S. Kim International Ltd-part of S.K.-Pharma Group
Moshe Aviv Tower, Jabotinsky 7, 35
th
floor, Ramat Gan, Israel 5252007
Tel.: [phone], Fax: [phone]
www.sk-pharma.com
טסוגוא
2018
ה/אפור
ה/דבכנ
,
ה/דבכנ ת/חקור
, רישכתה :ןודנה
-
PEMETREXED S.K. 500 MG
NFUSION
I
OLUTION FOR
S
ONCENTRATE FOR
C
OWDER FOR
P
רישכתה לש אפורל ןולעב ןוכדע לע עידוהל
וננוצרב
.ןודנבש
.הרמחה הווהמה יוניש השענ םהב םיפיעסל
קר תסחייתמ וז העדוה
.םיפסונ םיירונימ םינוכדע םימייק
:תרשואמה היוותהה
Malignant pleural mesothelioma
PEMETREXED S.K. 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 S.K. 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 S.K. 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 (see section 5.1).
PEMETREXED S.K. 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 (see
section 5.1).
ןוכדעה
ןולעב השענש יתוהמה
פורל
:ונה א
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
…
Nephrogenic diabetes insipidus and renal tubular necrosis were also
reported in post marketing setting with
pemetrexed alone or with other chemotherapeutic agents. Most of these
events resolved after pemetrexed
withdrawal. Patients should be regularly monitored f

Prekės savybės

Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
PEMETREXED S.K. 500 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of pemetrexed (as disodium
hemipentahydrate).
Excipients with known effect:
Each vial contains approximately 54 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 S.K. 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 S.K. 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 S.K. 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 S.K. 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
PEMETREXED S.K. must only be administered under the supervision of a
physician qualified in
the use of anti-cancer chemotherapy.
PEMETREXED S.K. in combination with cisplatin
The recommended dose of PEMETREXED S.K. is 500 mg/m
2
of body surface area (BSA) administered as
an intravenous infusion over 10 minutes on the first day of each
21-day cycle. The recommended dose of
cisplatin is 75 mg/m
2
BSA infused over two hours approximately 30 minute