PEMETREXED TEVA 1000 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

PEMETREXED

Dostopno od:

ABIC MARKETING LTD, ISRAEL

Koda artikla:

L01BA04

Farmacevtska oblika:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sestava:

PEMETREXED 1000 MG

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terapevtsko območje:

PEMETREXED

Terapevtske indikacije:

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.

Datum dovoljenje:

2021-05-31

Navodilo za uporabo

93.132.309-B
)بلقلا تلاضع خض ةوق يف رثؤت ةلاح( بلقلا
لمع روصق
ةمظتنم ريغ بلق مظن ةريتو
مضهلا رسع
كاسمإ
نطبلا يف ملأ
مدلا يف دبكلا اهجتني يتلا داوملا ةيمك
عافترا :دبكلا
دلجلا يف ديازتم غ
ّ
بصت
ج
ّ
يهت
ُ
م
ٌ
دلج
مهسلأا يمر ةبعل ةحولب هيبش حفط
رعشلا طقاست
(urticaria( ىرش
ىلكلا لمع روصق
ىلكلا ءادأ ضافخنا
ى
ّ
م
ُ
ح
ملأ
ا
ً
مروت ببسي يذلا ،مسجلا ةجسنأ يف لئاوسلا
طرف
ردصلا يف ملأ
يمضهلا زاهجلا يطغت يتلا ةيطاخملا
ةجسنلأا يف ةحرقو باهتلا
:1,000 نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ
)UNCOMMON( ةعئاش تسيل ةيبناج ضارعأ
ةيومدلا حئافصلاو ءاضيبلا ،ءارمحلا
مدلا ايلاخ تايوتسم ضافخنا
ةيغامد ةتكس
غامدلا ىلإ ا
ً
مد لقني نايرش دادسنا ببسب ثدحت ةتكس
)ةمجمجلا( فحقلا لخاد فيزن
)بلقلا ىلإ مدلا قفدت صقن ةجيتن ثدحي
ردصلا يف ملأ( ةيردص ةحبذ
ةيبلق ةبون
ةيجاتلا نييارشلا دادسنا وأ ق
ّ
يضت
ةعراستم بلق مظن ةريتو
فارطلأا ىلإ مدلا قفدت يف للخ
ةئرلا نييارش دحأ دادسنا
ةيسفنت لكاشم عم هبدنتو ةئرلا رادج
باهتلا
جرشلا ةحتف نم فيزن
يمضهلا زاهجلا يف فيزن
يعملا يف قزمت
ءيرملا ناردج باهتلا
جمدلا دنع طقف رهظي( ميقتسملا وأ
ءاعملأا نم فيزنب ا
ً
بوحصم نوكي دق يذلا ،نولوقلا ناردج يف
باهتلا
)نيتلاپسيس عم
يعاعشإ جلاع ببسب تلااحلا هذه ثدحتو
ءيرملا لضع حطس لكآتو ،ى
َ
ما
َ
م
ُ
ح ،ةمذو ،باهتلا
.يعاعش�

Lastnosti izdelka

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