Pemetrexed Seacross 100mg powder for concentrate for solution for infusion

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

pemetrexed (pemetrexed disodium heptahydrate)

זמין מ:

SEACROSS PHARMACEUTICALS LIMITED

קוד ATC:

L01BA04

INN (שם בינלאומי):

pemetrexed (pemetrexed disodium heptahydrate)

כמות:

100mg

טופס פרצבטיות:

powder for concentrate for solution for infusion

יחידות באריזה:

glass vial

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2022-06-22

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pemetrexed Seacross 100 mg powder for concentrate for solution for
infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipients with known effect:
Each 100 mg vial contains less than 1 mmol (11 mg) of sodium.
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 Seacross in combination with cisplatin is indicated for the
treatment of
chemotherapy naïve patients with unresectable malignant pleural
mesothelioma.
Non-small cell lung cancer
Pemetrexed Seacross 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 Seacross 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 Seacross 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Pemetrexed Seacross must only be administered under the supervision of
a physician
qualified in the use of anti-cancer chemotherapy.
Pemetrexed Seacross in combination with cisplatin
The recommended dose of Pemetrexed Seacross is 500 mg/m2 of body
surface area
(BSA) administered as an intravenous infusion over 10 minutes on the
first day of
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