Alimta

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

pemetrexed (pemetrexed disodium heptahydrate)

Доступно од:

Lilly France (S.A.S).

INN (Међународно име):

pemetrexed (pemetrexed disodium heptahydrate)

Дозирање:

500mg

Фармацеутски облик:

powder for concentrate for solution for infusion

Тип рецептора:

Prescription

Информативни летак

ALIMTA 100 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ALIMTA 500 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
ALIMTA 100 mg powder for concentrate for solution for infusion.
ALIMTA 500 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg or 500 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 approximately 11 mg sodium.
Each 500 mg vial contains approximately 54 mg sodium.
For the full list of excipients see section 6.1.
Not all strengths may be marketed.
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
ALIMTA in combination with cisplatin is indicated for the treatment of
chemotherapy naïve patients with unresectable malignant pleural
mesothelioma.
Non-small cell lung cancer
ALIMTA 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).
ALIMTA 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).
ALIMTA 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:
ALIMTA must only be administered under the supervision of a physician
qualified in the use of anti-cancer chemotherapy.
ALIMTA in combination with cisplatin
The recomm

Карактеристике производа

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
24
1.
NAME OF THE MEDICINAL PRODUCT
ALIMTA 500 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 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 vial contains approximately 54 mg 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
ALIMTA in combination with cisplatin is indicated for the treatment of
chemotherapy naïve patients
with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
ALIMTA 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).
ALIMTA 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).
ALIMTA 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:
ALIMTA must only be administered under the supervision of a physician
qualified in the use of
anti-cancer chemotherapy.
ALIMTA in combination with cisplatin
The recommended dose of ALIMTA 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 m