qanastek/EMEA-V3 huggingface dataset:
There were no clinically relevant differences observed for the safety profile of ALIMTA within the histology subgroups.
Ma ġewx osservati differenzi klinikament relevanti fil- profil ta 'sigurtà ta' ALIMTA fis- sottogruppi istoloġiċi.
Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression free survival) for pemetrexed are similar between patients previously pre treated with docetaxel (n=41) and patients who did not receive previous docetaxel treatment (n=540).
Informazzjoni klinika limitata, minn studju separat, kkontrollat u, randomised ta 'Fażi 3, tissuġġerixxi li l- informazzjoni dwar l- effikaċja (sopravivenza totali, sopravivenza mingħajr progressjoni) għal pemetrexed huma simili bejn il- pazjenti li kienu ġew ikkurati qabel b' docetaxel( n=41) u pazjenti li ma rċevewx kura b' docetaxel qabel (n=540).
Efficacy of ALIMTA vs docetaxel in NSCLC - ITT Population
13 Effikaċja ta ’ ALIMTA vs docetaxel f’ Popolazzjoni ITT - NSCLC
Survival Time (months) Median (m) 95% CI for median HR
Żmien ta ’ Sopravivenza (xhur) Medjan (m) 95% CI għal medjan HR
(n = 283) 8.3 (7.0 - 9.4)
(n = 283) 8. 3 (7. 0 - 9. 4)
(n = 288) 7.9 (6.3 - 9.2)
(n = 288) 7. 9 (6. 3 - 9. 2)
95% CI for HR Non-inferiority p-value (HR)
95% CI għal HR Il- valur- P (HR) mhux inferjuri
(.82 - 1.20) .226
(. 82 - 1. 20). 226
Progression free survival (months) Median HR (95% CI)
HR (95% CI)
0.97 (.82 – 1.16)
0. 97 (. 82 – 1. 16) (n = 288)
= 288) 2.9
Żmien sal- falliment tal- kura (TTTF – xhur)
Time to treatment failure (TTTF – months) Median HR (95% CI)
Medjan HR (95% CI)
(n = 283) 2.3
2. 3
0.84 (.71 - .997)
0. 84 (. 71 -. 997)
(n
2. 1
Response (n: qualified for response)
Respons (n: eliġibbli għar- respons)
Response rate (%) (95% CI) Stable disease (%)
Persentaġġ ta ’ respons (%) (95% CI) marda stabbli (%)
9.1 (5.9 - 13.2) 45.8
9. 1 (5. 9 - 13. 2) 45. 8
8.8 (5.7 - 12.8) 46.4
8. 8 (5. 7 - 12. 8) 46. 4
Abbreviations:
Abbrevjazzjonijiet:
CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
CI = intervall ta ’ kunfidenza; HR = proporzjon ta ’ riskju; ITT = intenzjoni li tikkura; n = daqs tal- popolazzjoni kollha
14 A multicentre, randomised, open-label, Phase 3 study of ALIMTA plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that ALIMTA plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI 0.84-1.05).
Studju ta ’ Fażi 3, open- label, randomised, magħmul f’ ħafna ċentri b’ ALIMTA flimkien ma ’ cisplatin kontra gemcitabine flimkien ma ’ cisplatin f’ pazjenti b’ kanċer tal- pulmun mhux b’ ċelluli żgħar (NSCLC) lokalment avanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li ALIMTA flimkien ma ’ cisplatin (popolazzjoni bl- Intenzjoni Li Tikkura (ITT) n = 862) laħaq l - endpoint primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma ’ cisplatin (ITT n=863) fis- sopravivenza totali (proporzjon aġġustat ta ’ riskju 0. 94; 95% CI 0. 84- 1. 05).
All patients included in this study had an ECOG performance status 0 or 1.
Il- pazjenti kollha inklużi f' dan l- istudju kellhom ECOG performance status ta ’ 0 jew 1.
The primary efficacy analysis was based on the ITT population.
L- analiżi ta ’ l- effikaċja primarja kienet ibbażata fuq il- popolazzjoni ITT.
Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Ġew evalwati wkoll l- analiżi ta ’ sensittività ta 'endpoints ta' effikaċja primarja fil- popolazzjoni Kwalifikata b' Protokoll (PQ).
The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of AC versus GC.
L - analiżi ta ’ l- effikaċja fil- popolazzjoni PQ huma konsistenti ma 'l- analiżi fil- popolazzjoni ITT u jikkonfermaw li AC m’ humiex inferjuri għal GC.
Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for ALIMTA plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95% CI 0.94-1.15), and overall response rate was 30.6% (95% CI 27.3- 33.9) for ALIMTA plus cisplatin versus 28.2% (95% CI 25.0-31.4) for gemcitabine plus cisplatin.
Il- medjan ta ’ PFS kien ta ’ 4. 8 xhur għal ALIMTA flimkien ma ’ cisplatin kontra 5. 1 xhur għal gemcitabine flimkien ma ’ cisplatin (proporzjon aġġustat ta ’ riskju 1. 04; 95% CI 0. 94- 1. 15), u r- rata ta 'rispons totali kien 30. 6% (95% CI 27. 3 - 33. 9) għal ALIMTA flimkien ma ’ cisplatin kontra 28. 2% (95% CI 25. 0- 31. 4) għal gemcitabine flimkien ma ’ cisplatin.
PFS data were partially confirmed by an independent review (400/ 1725 patients were randomly selected for review).
Id- data tal- PFS ġew parzjalment ikkonfermati minn stħarriġ indipendenti (400/ 1725 pazjent ġew magħżula b’ mod arbitrarju għall - istħarriġ).
The analysis of the impact of NSCLC histology on overall survival demonstrated clinically relevant differences in survival according to histology, see table below.
L- analiżi ta ’ l- impatt ta 'l- istoloġija ta' NSCLC fuq is- sopravivenza totali wriet differenzi statistikamet sinifikanti fis- sopravivenza skond il- fergħa ta ’ kura, ara t- tabella hawn taħt.
Efficacy of ALIMTA + Cisplatin vs.
L- Effikaċja Ta 'ALIMTA + Cisplatin vs.
Gemcitabine + Cisplatin in First-Line Non-Small Cell Lung Cancer – ITT Population and Histology Subgroups.
Gemcitabine + Cisplatin fil- Kura Preferita Tal - Kanċer Tal- Pulmun Mhux b’ Ċelluli Żgħar – Popolazzjoni ITT u Sottogruppi Istoloġiċi.
ITT Population
Popolazzjoni ITT u Sottogruppi
(95% CI)
Medjan ta 'Sopravivenza Totali f' Xhur (95% CI) Gemcitabine +
Hazard Ratio Superiority (HR) p-value
Proporzjon ta ’ Riskju Aġġustat
Subgroups
Valur- p ta '
ALIMTA + Cisplatin
Istoloġiċi
Gemcitabine + Cisplatin
ALIMTA + Cisplatin Cisplatin
(95% CI) a
(HR) (95% CI) 0. 94a
ITT Population
Superjorità
(N = 1725)
Popolazzjoni ITT (N = 1725)
(9.8 – 11.2)
10. 3 N=862 10. 3 (9. 8 – 11. 2) (9. 6 – 10. 9)
(9.6 – 10.9)
N=863
(0.84 – 1.05)
(0. 84 – 1. 05)
Adenocarcinoma
0. 259
12.6
Adenokarċinoma (N=847)
N=436
12. 6 N=436 10. 9 (10. 7 – 13. 6) (10. 2 – 11. 9)
0.84
0. 84 (0. 71– 0. 99)
0.033
0. 033
(N=847)
14
(10.7 – 13.6)
Ċellula Kbira (N=153)
(0.71– 0.99)
10. 4 N=76 6. 7 (8. 6 – 14. 1) (5. 5 – 9. 0)
(N=153)
0. 67 (0. 48– 0. 96)
(8.6
0. 027
(5.5 – 9.0)
Oħrajn (N=252)
(0.48– 0.96)
8. 6 N=106 9. 2 (6. 8 – 10. 2) (8. 1 – 10. 6)
(N=252)
1. 08 (0. 81– 1. 45)
(6.8
0. 586
Squamous Cell (N=473)
Ċellula tat- tip Squamous (N=473)
10.8 (9.5 – 12.1)
9. 4 N=244 10. 8 (8. 4 – 10. 2) (9. 5 – 12. 1)
1.23 (1.00– 1.51)
1. 23 (1. 00– 1. 51)
CI = confidence interval; ITT = intent-to-treat; N = total population size. a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001).
CI = intervall ta ’ kunfidenza; ITT = intenzjoni li tikkura; N = daqs tal - popolazzjoni kollha a Statistikament sinifikanti biex ma tkunx inferjuri, bl- intervall ta ’ kunfidenza għal HR kollu kemm hu ħafna taħt il- marġni ta '1. 17645 li turi li m’ hemmx inferjorità (p <. 001).
15 Kaplan Meier Plots of Overall Survival by Histology
Dijagrammi Kaplan Meier tas- Sopravivenza Totali skont l- Istoloġija Karċinoma ta 'Ċellula Kbira 1. 0 Adenokarċinoma 1. 0 0. 9 AC
Large Cell Carcinoma
Probabbiltà ta 'Sopravivenza
0.9
0. 8
GC
GC GC
Survival Probability Survival Probability
Probabbiltà ta 'Sopravivenza 0. 8 0. 7 0. 7 0. 6 0. 6 0. 5 0. 5 0. 4 0. 4
0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0
0. 3 0. 2 0. 1 0. 0
Survival Time (months)
Żmien ta 'Sopravivenza (xhur)) Żmien ta' Sopravivenza (xhur)
There were no clinically relevant differences observed for the safety profile of ALIMTA plus cisplatin within the histology subgroups.
Ma dehrux differenzi klinikament rilevanti fil- profil ta ’ sigurtà ta ’ Alimta flimkien ma ’ cisplatin fis - sottogruppi ta ’ istoloġija.
Patients treated with ALIMTA and cisplatin required fewer transfusions (16.4% versus 28.9%, p < 0.001), red blood cell transfusions (16.1% versus 27.3%, p < 0.001) and platelet transfusions (1.8% versus 4.5%, p=0.002).
Pazjenti kkurati b' ALIMTA u cisplatin kellhom bżonn ta 'anqas trasfużjonijiet (16. 4% kontra 28. 9%, p < 0. 001), trasfużjonijiet ta' ċelluli ħomor tad- demm (16. 1% kontra 27. 3%, p < 0. 001) u trasfużjonijiet ta 'plejtlits (1. 8% kontra 4. 5%, p=0. 002).
Patients also required lower administration of erythropoietin/ darbopoietin (10.4% versus 18.1%, p < 0.001), G-CSF/ GM-CSF (3.1% versus 6.1%, p=0.004), and iron preparations (4.3% versus 7.0%, p=0.021).
Il- pazjenti kellhom bżonn ukoll ta 'anqas għotjiet ta' erythropoietin/ darbopoietin (10. 4% kontra 18. 1%, p < 0. 001), G- CSF/ GM- CSF (3. 1% kontra 6. 1%, p=0. 004), u preparazzjonijiet ta 'ħadid (4. 3% kontra 7. 0%, p=0. 021).
Pemetrexed has a steady-state volume of distribution of 9 l/ m2.
Wara l- għoti ta ’ pemetrexed bħala mediċina weħidha, il- proprjetajiet farmakokinetiċi ta ’ pemetrexed ġew evalwati f’ dożi li jvarjaw bejn 0. 2 sa 838 mg/ m2 infużi fuq perijodu ta ’ għaxar minuti f’ 426 pazjent bil- kanċer li kellhom diversi tumuri solidi. Pemetrexed għandu volum tad- distribuzzjoni fiss ta ’ 9 l/ m2.
Pemetrexed undergoes limited hepatic metabolism.
Studji in vitro jindikaw li madwar 81% ta ’ pemetrexed jintrabat mal- proteini tal- plażma. Ir - rabta ma kinitx influwenzata b’ mod partikolari minn gradi differenti ta ’ indeboliment tal - kliewi. Pemetrexed jiġi metabolizzat b’ mod limitat fil- fwied.
Pemetrexed is primarily eliminated in the urine, with 70% to 90% of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Pemetrexed jiġi primarjament eliminat fl - awrina, b’ 70% sa 90% tad- doża mgħotija rkuprata mingħajr ebda modifikazzjoni fl- awrina fl- ewwel 24 siegħa minn meta tkun ngħatat id- doża.
Pemetrexed total systemic clearance is 91.8 ml/ min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/ min).
It- tneħħija sistemika totali ta ’ Pemetrexed hija ta ’ 91. 8 ml/ min u l- half- life ta ’ l- eliminazzjoni mill- plażma hija ta ’ 3. 5 sigħat f’ pazjenti b’ funzjoni tal- kliewi normali (tneħħija tal- krejatinina ta ’ 90 ml/ min).
Between patient variability in clearance is moderate at 19.3%.
Il- varjabilità fit- tneħħija bejn il- pazjenti hija moderata f’ perċentwali ta ’ 19. 3%.
Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose.
L- espożizzjoni sistemika totali (AUC) u l- ogħla konċentrazzjoni fil- plażma ta ’ Pemetrexed jiżdiedu proporzjonament mad- doża.
The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Il - farmakokinetiċi ta ’ pemetrexed huma konsistenti f’ diversi ċikli ta ’ kura.
The pharmacokinetic properties of pemetrexed are not influenced by concurrently administered cisplatin.
15 Il- proprjetajiet farmakokinetiċi ta ’ pemetrexed mhumiex influwenzati bl- għoti fl- istess ħin ta ’ cisplatin.
Oral folic acid and intramuscular vitamin B12 supplementation do not affect the pharmacokinetics of pemetrexed.
Is- supplimentazzjoni ta ’ folic acid b’ mod orali u tal- vitamina B12 minn ġol- muskoli ma jinfluwenzawx il- farmakokinetika ta ’ pemetrexed.
Administration of pemetrexed to pregnant mice resulted in decreased foetal viability, decreased foetal weight, incomplete ossification of some skeletal structures and cleft palate.
L- għoti ta ’ pemetrexed lill- ġrieden tqal irriżulta fi tnaqqis fil- vijabiltà tal- fetu, tnaqqis fil- piż tal- fetu, f’ xi strutturi skeletali ma kinitx kompluta l- ossifikazzjoni, u cleft palate.
Administration of pemetrexed to male mice resulted in reproductive toxicity characterised by reduced fertility rates and testicular atrophy.
L- għoti ta ’ pemetrexed lill- ġrieden maskili rriżulta f’ tossiċità fis- sistema riproduttiva, kkaratterizzata b’ rati mnaqqsa ta ’ fertilità u atrofija testikulari.
In a study conducted in beagle dog by intravenous bolus injection for 9 months, testicular findings (degeneration/ necrosis of the seminiferous epithelium) have been observed.
Fi studju magħmul f’ kelb tar- razza beagle, fejn ġiet mogħtija injezzjoni bolus minn ġol- vini għal 9 xhur, ġie osservat tibdil fit- testikoli (deġenerazzjoni/ nekrożi ta ’ l- epitelju seminiferu).
This suggests that pemetrexed may impair male fertility.
Dan jissuġġerixxi li pemetrexed jista ’ jdgħajjef il - fertilità maskili.
Female fertility was not investigated.
Il- fertilità femminili ma ġietx investigata.
Pemetrexed has been shown to be clastogenic in the in vivo micronucleus test in the mouse.
Pemetrexed ma kienx mutaġeniku kemm fl- studju in vitro ta ’ aberrazzjoni kromosomali li sar fuq iċ - ċelluli ovarji tal- ħamster Ċiniż kif ukoll fl- istudju Ames. Fl- istudju mikronuklejiku in vivo li sar fil - ġurdien, deher li pemetrexed huwa klastoġeniku.
Studies to assess the carcinogenic potential of pemetrexed have not been conducted.
Ma sarux studji biex jitkejjel il- potenzjal karċinoġeniku ta ’ pemetrexed.
Mannitol Hydrochloric acid Sodium hydroxide
Mannitol Hydrochloric acid Sodium hydroxide
Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer’ s Injection and Ringer’ s Injection.
Pemetrexed huwa fiżikament inkompatibbli ma dilwenti li fihom calcium, inklużi l- Injezzjoni ta ’ lactated Ringer u l- Injezzjoni ta ’ Ringer.
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Fin- nuqqas ta ’ studji ta ’ kompatibilità (ma ’ mediċini u dilwenti oħra), dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra.
Reconstituted and Infusion Solutions:
Soluzzjonijiet Rikostitwiti u ta ’ Infużjoni:
When prepared as directed, reconstituted and infusion solutions of ALIMTA contain no antimicrobial preservatives.
Meta ppreparati kif suppost, is- soluzzjonijiet rikostitwiti u ta ’ infużjoni ta ’ ALIMTA ma jkun fihom ebda preservattiv antimikrobiku.
Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature or 25°C.
L- istabbilità kimika u fiżika ta ’ waqt l- użu, tas- soluzzjonijiet rikostitwiti u ta ’ infużjoni ta ’ pemetrexed ġiet ippruvata għal 24 siegħa f’ temperatura ta ’ friġġ jew ta ’ 25°C.
From a microbiological point of view, the product should be used immediately.
Minħabba l- fatt mikrobijoliġiku, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużawx immedjatament, iż- żminijiet ta ’ ħażna waqt l- użu u l - kundizzjonijiet ta ’ qabel l- użu huma r- risponsabbiltà ta ’ min qed juża l- prodott u normalment m’ għandhomx ikunux itwal minn 24 siegħa f’ temperaturi ta ’ bejn 2°C u 8°C, sakemm ir- rikostituzzjoni / dilwizzjoni ma jkunux saru f’ kundizzjonijiet asettiċi kkontrollati u validati.
Unopened vial:
Kunjett mhux miftuħ:
This medicinal product does not require any special storage conditions.
Din il- medicina m’ għandiex bżonn ħażna speċjali
Powder in Type I glass vial.
Trab f’ kunjett tal- ħġieġ ta ’ Tip I.
Rubber stopper.
Tapp tal- lasktu.
Pack of 1 vial.
Pakkett b’ kunjett wieħed.
17 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Uża teknika asettika matul ir- rikostituzzjoni u għal iżjed dilwizzjoni ta ’ pemetrexed għall- għoti ta ’ l- infużjoni fil- vini.
Calculate the dose and the number of ALIMTA vials needed.
Ikkalkula d- doża u n- numru ta 'kunjetti ta' ALIMTA li hemm bżonn.
Each vial contains an excess of pemetrexed to facilitate delivery of label amount.
Kull kunjett fih ammont żejjed ta 'pemetrexed sabiex jiffaċilita l- għoti ta' l- ammont miktub fuq it- tikketta.
Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
Irrikostitwixxi kunjetti ta '100mg b' 4. 2 ml ta' soluzzjoni għall- injezzjoni ta '9mg/ ml (0. 9%) sodium chloride, mingħajr preservattiv, li jirriżulta f' soluzzjoni li jkollha 25 mg/ ml pemetrexed.
Gently swirl each vial until the powder is completely dissolved.
Dawwar bil- mod kull kunjett sakemm it- trab ikun inħall kompletament.
The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality.
Is- soluzzjoni li tirriżulta hija ċara u tvarja minn bla kulur sa kulur safrani jew safrani fl- aħdar mingħajr ma tiġi affettwata b’ mod negattiv il- kwalità tal- prodott.
The pH of the reconstituted solution is between 6.6 and 7.8.
Il- pH tas- soluzzjoni rikostitwita hi bejn 6. 6 u 7. 8.
Further dilution is required.
Ikun meħtieġ iżjed dilwizzjoni
The appropriate volume of reconstituted pemetrexed solution should be further diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Il- volum xieraq tas- soluzzjoni rikostitwita ta ’ pemetrexed għandu jerġa ’ jiġi dilwit sa 100ml b ’ soluzzjoni għall- injezzjoni ta ’ 9mg/ ml( 0. 9%) sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil- vini għal 10 minuti.
Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Soluzzjonijiet ta 'infużjoni ta ’ pemetrexed ippreparati kif indikat hawn fuq huma kompatibbli ma' settijiet għall- għoti u boroż ta ’ l- infużjoni miksija bil- polyvinyl chloride u polyolefin.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Qabel ma jingħataw, prodotti mediċinali mgħotija permezz ta ’ injezzjoni għandhom jiġu eżaminati viżwalment għal preżenza ta ’ xi frak u telf ta ’ kulur.
If particulate matter is observed, do not administer.
Tinjettax jekk jiġi osservat xi frak.
Pemetrexed solutions are for single use only.
Soluzzjonijiet ta ’ pemetrexed għandhom jintużaw darba biss.
Preparation and administration precautions:
Prekawzjonijiet fil- preparazzjoni u l- amministrazzjoni:
As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
L- immaniġġar u l- preparazzjoni ta ’ soluzzjonijiet ta ’ infuzjoni ta ’ pemetrexed għandhom isiru b’ attenzjoni kif isir b’ sustanzi oħra kontra l - kanċer u potenzjalment tossiċi.
The use of gloves is recommended.
Hu rrakkomandat li jintużaw l- ingwanti.
If a pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water.
F' każ li s- soluzzjoni ta ’ pemetrexed tiġi f' kuntatt mal- ġilda, aħsel sew il- ġilda bis- sapun u bl- ilma immedjatament.
If pemetrexed solutions contact the mucous membranes, flush thoroughly with water.
Jekk soluzzjonijiet ta ’ pemetrexed jiġu f’ kuntatt mal- membrani mukużi, laħlaħ sew bl- ilma.
Pemetrexed is not a vesicant.
Pemetrexed mhuwiex visikant.
There is not a specific antidote for extravasation of pemetrexed.
M' hemmx antidotu speċifiku għall- estravażjoni ta ’ pemetrexed.
There have been few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator.
Ġew irrapportati xi każijiet ta ’ estravażjoni ta ’ pemetrexed, li ma ġewx meqjusa bħala serji mill- investigatur.
Extravasation should be managed by local standard practice as with other non-vesicants.
L - estravażjoni għandha tiġi kkontrollata permezz tal- prattika lokali standardizzata kif issir b’ sustanzi oħra li mhumiex visikanti.
Eli Lilly Nederland B. V., Grootslag 1-5, NL-3991 RA, Houten, The Netherlands.
Eli Lilly Nederland B. V., Grootslag 1- 5, NL - 3991 RA, Houten, L- Olanda
20 September 2004
20 ta ’ Settembru 2004
ALIMTA 500 mg powder for concentrate for solution for infusion
ALIMTA 500 mg trab għal konċentrat għal soluzzjoni għall- infużjoni
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Kull kunjett fih 500 mg ta ’ pemetrexed (bħala pemexetred disodium).
Each vial must be reconstituted with 20 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection resulting in 25 mg/ ml of solution.
Kull kunjett għandu jkun rikostitwit ma ’ 20 ml soluzzjoni għall- injezzjoni ta ’ 9mg/ ml (0. 9%) sodium chloride li jirriżulta f’ soluzzjoni ta ’ 25 mg/ ml.
ALIMTA in combination with cisplatin:
ALIMTA flimkien ma 'cisplatin:
The recommended dose of ALIMTA is 500 mg/ m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Id- doża rakkomandata ta ’ ALIMTA hi ta ’ 500 mg/ m2 ta ’ l- erja tas - superfiċje tal- ġisem (BSA) mogħtija bħala infużjoni minn ġol- vina fuq perijodu ta ’ 10 minuti fl- ewwel ġurnata ta ’ kull ċiklu ta ’ 21 ġurnata.
19 ALIMTA as single agent:
19 ALIMTA mogħti waħdu:
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of ALIMTA is 500 mg/ m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
F’ pazjenti kkurati għall- kanċer tal- pulmun mhux b’ ċelluli żgħar wara kimoterapija preċedenti, id- doża rakkomandata ta ’ ALIMTA hi ta ’ 500 mg/ m2 BSA mogħtija b’ infużjoni minn ġol- vina fuq perijodu ta ’ 10 minuti fl- ewwel ġurnata ta ’ kull ċiklu ta ’ 21 ġurnata.
20 Table 2 - Dose Modification Table for ALIMTA (as single agent or in combination) and Cisplatin– Non-haematologic Toxicities a, b
20 TABELLA 2 – Tabella Għall- Modifikazzjoni Fid- Doża ta ’ ALIMTA (bħala sustanza waħdenija jew f’ terapija kombinata) u Cisplatin – Tossiċitajiet li mhumiex ematoloġiċia, b Doża ta ’ cisplatin (mg/ m2) Doża ta ’ ALIMTA 2 (mg/ m)
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Kriterji ta ’ Tossiċità Komuni ta 'l - Istitut Nazzjonali tal- Kanċer (CTC) (v2. 0; NCI 1998) b Minbarra n- newrotossiċità
CTCa Grade
Grad CTCa
100% of previous dose
100% tad- doża ta ’
100% of previous dose
qabel 100% tad- doża ta ’ qabel
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Kriterji ta ’ Tossiċità Komuni ta 'l- Istitut Nazzjonali tal- Kanċer (CTC v 2. 0; NCI 1998)
Breast-feeding must be discontinued during pemetrexed therapy (see section 4.6).
21 It- treddigħ għandu jieqaf matul it- terapija b’ pemetrexed (ara Sezzjoni 4. 6).
21 Concomitant yellow fever vaccine (see section 4.5).
Vaċċin tal- yellow fever fl- istess żmien (ara Sezzjoni 4. 5).
Immunodepressed status is common in cancer patients.
22 L- immunodipressjoni hija komuni f’ pazjenti li jkollhom kanċer.
Contraceptive measures or abstinence are
Huma rakkomandati miżuri ta ’ kontraċezzjoni jew l- astinenza.
In the absence of data regarding potential interaction with NSAIDs having longer half-lives as piroxicam or rofecoxib, the concomitant administration with pemetrexed should be avoided for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Fin- nuqqas ta ’ tagħrif dwar l- interazzjoni potenzjali ma ’ NSAIDs li jkollhom half- life itwal bħal piroxicam jew rofecoxib, l- għoti ta ’ pemetrexed fl- istess żmien għandu jkun evitat mill- anqas minn 5 ijiem qabel, dakinhar, sa mill- inqas jumejn wara l- għoti ta ’ pemetrexed (ara sezzjoni 4. 4).
The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
23 bżonn ta ’ monitoraġġ ta ’ l- INR (International Normalised Ratio) aktar spiss, jekk ikun deċiż li l - pazjent għandu jingħatalu kura b’ antikoagulanti orali.
The risk is increased in subjects who are already immunosuppressed by their underlying disease.
Ir - riskju jikber f’ persuni li jkunu diġà immunosoppressi minħabba l- marda li jkollhom.
Use an inactivated vaccine where it exists (poliomyelitis) (see section 4.4).
Uża vaċċin inattivat jekk ikun jeżisti (poljomajelite) (ara sezzjoni 4. 4).
24 System Organ
24 Sistema tal - klassifika ta ’ l -
Blood and Lymphatic System
Disturbi fid - Demm u fis - Sistema limfatika
13.5 3.1
13. 5
Disorders
3. 1
Tissue Disorders
Taħt il- Ġilda
*Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “ creatinine clearance decreased” ** which is derived from the term “ renal/ genitourinary other”. *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
* Irreferi għal verżjoni 2 tas - CTC ta 'l- Istitut Nazzjonali tal- Kanċer għal kull grad ta ’ tossiċità ħlief għat- terminu “ tnaqqis fit- tneħħija tal- krejatinina ” ** li ġejja mit- terminu “ renali/ ġenito- awrinarji oħrajn ”. *** Skont is- CTC (v 2. 0; NCI 1998) ta ’ l- Istitut Nazzjonali tal- Kanċer, it- tibdil fit- togħma u l - alopeċja għandhom jiġu rrapportati biss bħala Grad 1 jew 2.
25 Very common ≥ 10%; Common is normally defined as ≥ 1% and < 10%.
25 Komuni ħafna > 10%; Komuni huwa normalment definit bħala > 1% u < 10%.
Clinically relevant CTC toxicities that were reported in ≥ 1% and < 5% (common) of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f ’ > 1% u < 5% (komuni) tal- pazjenti li ntgħażlu bl- addoċċ biex jirċievu cisplatin u pemetrexed jinkludu: insuffiċjenza renali, infezzjoni, deni, newtropenja bid- deni, żieda fl- AST, ALT u GGT, urtikarja, u uġigħ fis- sider.
14.0
14. 0
0.0
0. 0 6. 2
Very common ≥ 10%; Common is normally defined as ≥ 1% and < 10%.
26 Komuni ħafna > 10%; Komuni huwa normalment definit bħala > 1% u < 10%.
26 Clinically relevant CTC toxicities that were reported in ≥ 1% and < 5% (common) of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/ hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f ’ > 1% u < 5% (komuni) tal- pazjenti li ntgħażlu bl- addoċċ biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja newtropenja bid- deni, reazzjoni allerġika/ sensittivita aċċessiva, żieda fil- krejatinina, newropatija motorja, newropatija sensittiva, eritema multiforme u wġigħ addominali.
27 System Organ Class
27 Sistema tal - klassifika ta ’ l - organi
Blood and Lymphatic
Disturbi fid - Demm u fis -
Hemoglobin decreased
Tnaqqis fl - emoglobina
45.7* 9.9*
45. 7 *
System Disorders
Sistema Limfatika
29.0* 15.1*
38. 4 *
38.4* 26.7*
26. 7 *
17.8 4.8*
20. 6
20.6 7.6*
7. 6 *
10.1* 4.1*
26. 6 *
26.6* 12.7*
12. 7 *
Diarrhea without colostomy
Dijarrea mingħajr kolostomija
AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
28 Tossiċitajiet klinikament rilevanti li ġew irrapportati f ’ ≥ 1% u ≤5% (komuni) tal- pazjenti li ntgħażlu bl- addoċċ biex jirċievu cisplatin u pemetrexed jinkludu: żieda fl- AST, żieda fl- ALT, infezzjoni, newtropenja bid- deni, insuffiċjenza renali, deni, diżidratazzjoni, konġuntivite u tnaqqis fit- tneħħija ta 'krejatinina.
GGT increase, chest pain, arrhythmia, and motor neuropathy.
Tossiċitajiet klinikament rilevanti li ġew irrapportati f ’ < 1% (mhux komuni) tal- pazjenti li b’ mod arbitrarju ntgħażlu biex jirċievu cisplatin u pemetrexed jinkludu: żieda fil- GGT, uġigħ fis- sider, arritmja, u newropatija motorja.
Cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Każijiet ta ’ insuffiċjenza renali akuta ġew irrapportati meta ntuża pemetrexed waħdu jew flimkien ma ’ sustanzi kimoterapewtiċi oħra (ara sezzjoni 4. 4).
Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy (see section 4.4) Cases of radiation recall have been reported in patients who have received radiotherapy previously (see section 4.4).
Ġew irrapportati każijiet fejn reġgħu dehru l- effetti tar- radjazzjoni f’ pazjenti li kienu rċevew ir - radjoterapija qabel (ara sezzjoni 4. 4).
Cases of peripheral ischemia leading sometimes to extremity necrosis have been reported.
Ġew irrapportati każijiet ta ’ iskemija periferali li xi kultant waslu għal nekrożi fl- estremitajiet.
Efficacy of ALIMTA plus Cisplatin vs.
30 Effikaċja ta ’ ALIMTA ma ’ Cisplatin vs.
Cisplatin in Malignant Pleural Mesothelioma
Cisplatin f’ Mesoteljoma Plewrali Malinna Pazjenti mogħtija Pazjenti magħżula bl - suppliment addoċċ u kkurati tul it- terapija kollha Parametru ta ’ Effikaċja
(7.8 - 10.7) (11.4 - 14.9) 0.051
(7. 8 - 10. 7) (11. 4 - 14. 9) 0. 051
(8.4 - 11.9)
(8. 4 - 11. 9)
3.9 6.1
3. 9 6. 1
(4.9 – 6.5) 0.001
(4. 9 - 6. 5) 0. 001
(2.8 - 4.4) (5.3 - 7.0) 0.008
(2. 8 - 4. 4) (5. 3 - 7. 0) 0. 008
4.5 (3.9 – 4.9) 0.001
4. 5 (3. 9 - 4. 9) 0. 001
2.7 4.7 (2.1 - 2.9) (4.3 - 5.6) 0.001
2. 7 4. 7 (2. 1 - 2. 9) (4. 3 - 5. 6) 0. 001
16.7% 45.5%
16. 7% 45. 5%
(34.8 - 48.1)
(34. 8 - 48. 1)
(12.0 - 22.2) (37.8 - 53.4)
(12. 0 - 22. 2) (37. 8 - 53. 4)
Fisher’ s exact p-value* Abbreviation:
Fisher’ s exact p- value *
30
CI = Intervall ta ’ Kunfidenza
** In the ALIMTA/ cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
* p- value jirreferi għat- tqabbil ta ’ bejn iż- żewġ fergħat ** Fil- fergħa ta ’ ALIMTA/ cisplatin, ntgħażlu bl- addoċċ u kkurati (N = 225) u mogħtija suppliment tul it- terapija kollha (N = 167)
Efficacy of ALIMTA vs docetaxel in NSCLC - ITT Population
31 Effikaċja ta ’ ALIMTA vs docetaxel f’ Popolazzjoni ITT - NSCLC
Progression free survival (months) Median
Sopravivenza mingħajr progressjoni (xhur) Medjan
= 283) 2.9
(n = 283) 2. 9
= 288) 2.9
(n = 288) 2. 9
(n
0. 97 (. 82 – 1. 16) (n = 288)
= 288) 2.1
Żmien sal- falliment tal- kura (TTTF – xhur)
HR (95% CI)
Medjan HR (95% CI)
31 A multicentre, randomised, open-label, Phase 3 study of ALIMTA plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that ALIMTA plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI 0.84-1.05).
Studju ta ’ Fażi 3, open- label, randomised, magħmul f’ ħafna ċentri b’ ALIMTA flimkien ma ’ cisplatin kontra gemcitabine flimkien ma ’ cisplatin f’ pazjenti b’ kanċer tal- pulmun mhux b’ ċelluli żgħar (NSCLC) lokalment avanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li ALIMTA flimkien ma ’ cisplatin (popolazzjoni bl- Intenzjoni Li Tikkura (ITT) n = 862) laħaq l - endpoint primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma ’ cisplatin (ITT n=863) fis- sopravivenza totali (proporzjon aġġustat ta ’ riskju 0. 94; 95% CI 0. 84- 1. 05).
Gemcitabine + Cisplatin
Cisplatin
(95% CI) a
(95% CI) Popolazzjoni ITT
ITT Population
N=862 10. 3 N=863 0. 94a
10.3 N=862
10. 3 N=862 10. 3
0.94
0. 94a
0.259
0. 259
(9.8 – 11.2)
(9. 8 – 11. 2)
(9.6 – 10.9)
(9. 6 – 10. 9)
Adenocarcinoma
Adenokarċinoma
12.6
12. 6
(10.7 – 13.6)
(10. 7 –
(10.2
(10. 2 – 11. 9)
– 11.9)
(0. 71– 0. 99)
(0.71– 0.99)
32 13. 6)
Large Cell
Ċellula Kbira
0.027
0. 027
(N=153)
(N=153) Oħrajn
– 14.1)
(8. 6 – 14. 1) (5. 5 – 9. 0) 8. 6
(5.5 – 9.0)
(0. 48– 0. 96)
(0.48– 0.96)
(N=252) Ċellula tat- tip
9.2
9. 2 (6. 8 – 10. 2) (8. 1 – 10. 6) 9. 4
Squamous Cell (N=473)
Squamous (N=473)
10.8 (9.5 – 12.1)
10. 8 (8. 4 – 10. 2) (9. 5 – 12. 1)
32 Kaplan Meier Plots of Overall Survival by Histology
Dijagrammi Kaplan Meier tas- Sopravivenza Totali skont l- Istoloġija
Adenocarcinoma
Probabbiltà ta 'Sopravivenza
Large Cell Carcinoma
Adenokarċinoma
AC
Karċinoma ta 'Ċellula Kbira AC
0.8
Probabbiltà ta 'Sopravivenza
GC
0. 8 0. 7 0. 6 0. 5 0. 4 0. 3 0. 2 0. 1 0. 0
0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0
0. 8 0. 7 0. 6 0. 5 0. 4 0. 3 0. 2 0. 1 0. 0
0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0
GC
Survival Time (months)
Żmien ta 'Sopravivenza (Xhur) Żmien ta' Sopravivenza (Xhur)
Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose.
L- espożizzjoni sistemika totali (AUC) u l- ogħla konċentrazzjoni fil- plażma
The pharmacokinetic properties of pemetrexed are not influenced by concurrently administered cisplatin.
Il- proprjetajiet farmakokinetiċi ta ’ pemetrexed mhumiex influwenzati bl- għoti fl- istess ħin ta ’ cisplatin.
6.5 Nature and contents of container
34 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
34 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Uża teknika asettika matul ir- rikostituzzjoni u għal iżjed dilwizzjoni ta ’ pemetrexed għall - għoti ta ’ l- infużjoni fil- vini.
Calculate the dose and the number of ALIMTA vials needed.
Ikkalkula d- doża u n- numru ta ’ kunjetti ta ’ ALIMTA li hemm bżonn.
Each vial contains an excess of pemetrexed to facilitate delivery of label amount.
Kull kunjett fih ammont żejjed ta ’ pemetrexed sabiex jiffaċilita l- għoti ta ’ l- ammont miktub fuq it- tikketta.
Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
Irrikostitwixxi kunjetti ta ’ 500mg b’ 20 ml ta ’ soluzzjoni għall- injezzjoni ta ’ 9mg/ ml (0. 9%) sodium chloride, mingħajr preservattiv, li jirriżulta f’ soluzzjoni li jkollha 25 mg/ ml pemetrexed.
The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality.
Is - soluzzjoni li tirriżulta hija ċara u tvarja minn bla kulur sa kulur safrani jew safrani fl- aħdar mingħajr ma tiġi affettwata b’ mod negattiv il- kwalità tal- prodott.
Further dilution is required.
Ikun meħtieġ iżjed dilwizzjoni.
35 ANNEX II
36 ANNESS II
36 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
2 rue du Colonel Lilly 67640 Fegersheim France
2 rue du Colonel Lilly 67640 Fegersheim Franza
Summary of Product Characteristics, 4.2)
Sommarju tal - Karatteristiċi tal - Prodott, sezzjoni 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritt fil- verżjoni 2. 0 ippreżentat fit- Taqsima 1. 8. 1 ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq, qiegħda preżenti u qiegħda taħdem qabel ma jpoġġi l- prodott fuq is- suq u waqt li l - prodott qiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġar tar- Riskju Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq jintrabat li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mniżżlin fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni ’ l. 2 tal- Pjan dwar l- Immaniġġar tar- Riskju (PIR) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ kull aġġornament tal- PIR li jista ’ jkun hemm u li jkun qabel miegħu is - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Kif hemm fil- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, il- PIR aġġornat għandu jiġi ppreżentat fl- istess żmien mar- Rapport ta ’ Aġġornament Perjodiku dwar is- Sigurtà (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimization Activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Fi żmien 60 ġurnata minn meta jkun deċiż xi avveniment importanti (ta ’ farmakoviġilanza jew tat- tnaqqis tar- riskju)
37 ANNEX III
•
38 LABELLING
38 ANNESS III
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
39 TIKKETTA
ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed
ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall- infużjoni pemetrexed
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Kull kunjett fih 100 mg ta ’ pemetrexed (bħala pemetrexed disodium).
After reconstitution with 4.2 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, each vial contains 25 mg/ ml of pemetrexed.
Wara r- rikostituzzjoni b’ 4. 2 ml ta ’ soluzzjoni għall- injezzjoni ta ’ 9mg/ ml (0. 9%) sodium chloride, kull kunjett ikun fih 25mg/ ml ta ’ pemetrexed.
Further dilution required prior to intravenous infusion (see package leaflet).
Ikun hemm bżonn ta ’ iżjed dilwizzjoni qabel ma ’ tingħata l- infużjoni fil- vini (ara il- fuljett ta ’ tagħrif)
Mannitol, hydrochloric acid, sodium hydroxide.
Mannitol, hydrochloric acid, sodium hydroxide.
1 vial, powder for concentrate for solution for infusion.
Kunjett wieħed, trab għal konċentrat għal soluzzjoni għall- infużjoni
For intravenous use after reconstitution and dilution.
Għall- użu għal ġol- vini wara r- rikostituzzjoni u dilwizzjoni Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Read the package leaflet before use.
Għall- użu ta ’ darba biss.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
Discard unused contents appropriately.
Armi b’ mod xieraq kull ħaġa li ma ntużatx.
Eli Lilly Nederland B. V., Grootslag 1-5, NL-3991 RA, Houten, The Netherlands
Eli Lilly Nederland B. V., Grootslag 1- 5, NL- 3991 RA, Houten, L- Olanda
CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
41 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed For intravenous use after reconstitution and dilution.
ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall- infużjoni pemetrexed Għall- użu għal ġol- vini wara r- rikostituzzjoni u d- dilwizzjoni
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
ALIMTA 500mg trab għal konċentrat għal soluzzjoni għall- infużjoni pemetrexed
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Kull kunjett fih 500mg ta ’ pemetrexed (bħala pemetrexed disodium).
After reconstitution with 20 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, each vial contains 25 mg/ ml of pemetrexed.
Wara r- rikostituzzjoni b’ 20ml ta ’ soluzzjoni għall- injezzjoni ta ’ 9mg/ ml (0. 9%) sodium chloride, kull kunjett ikun fih 25mg/ ml ta ’ pemetrexed.
44 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed For intravenous use after reconstitution and dilution.
ALIMTA 500mg trab għal konċentrat għal soluzzjoni għall- infużjoni pemetrexed Għall- użu għal ġol- vini wara r- rikostituzzjoni u d- dilwizzjoni
46 PACKAGE LEAFLET:
46 FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
47 FULJETT TA ’ TAGĦRIF:
ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion
Alimta 100 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni Alimta 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni
Read all of this leaflet carefully before you start receiving this medicine.
Aqra sew dan il- fuljett kollu qabel ma tibda tieħu din il- mediċina.
- If you have further questions, please ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
Tista ’ tagħmillhom
if their symptoms are the same as yours.
il- ħsara, anki jekk għandhom l- istess sintomi bħal tiegħek.
What ALIMTA is and what it is used for 2.
X’ inhi ALIMTA u għalxiex tintuża 2.
Before you are given ALIMTA 3.
Qabel ma tingħata ALIMTA 3.
How ALIMTA is given 4.
Kif tingħata ALIMTA 4.
How to store ALIMTA 6.
Kif taħżen ALIMTA 6.
WHAT ALIMTA IS AND WHAT IT IS USED FOR
X’ INHI ALIMTA U GĦALXIEX TINTUŻA
ALIMTA is a medicinal product used in the treatment of cancer.
ALIMTA hija prodott mediċinali li tintuża fil- kura tal- kanċer.
ALIMTA is a treatment for malignant pleural mesothelioma, which is given in combination with cisplatin, another anti-cancer medicine, to patients who have not received prior chemotherapy.
ALIMTA tintuża fil- kura tal- mesoteljoma plewrali malinna, u tingħata ma ’ cisplatin, kura oħra kontra l- kanċer, lil pazjenti li jkunu għadhom ma ngħatawx kimoterapija.
ALIMTA is also a treatment, which is given in combination with cisplatin, for the initial treatment of patients with advanced stage of lung cancer.
ALIMTA jintuża wkoll, flimkien ma 'cisplatin, fil- kura inizjali ta' pazjenti b' kanċer tal- pulmun f' stadju avanzat.
ALIMTA is also a treatment for patients with advanced stage of lung cancer after other chemotherapy has been used.
ALIMTA jintuża wkoll fil- kura ta ’ pazjenti b' stadju avvanzat tal- kanċer tal- pulmun wara li tkun intużat kimoterapija oħra.
BEFORE YOU ARE GIVEN ALIMTA
QABEL MA TIEĦU ALIMTA
You should not be given ALIMTA:
TIEĦUX ALIMTA
- if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of ALIMTA.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal pemetrexed jew sustanzi oħra ta ’
- if you are breast-feeding; you must discontinue breast-feeding during treatment with ALIMTA.
- jekk qiegħda tredda ’, trid twaqqaf it- treddigħ waqt il- kura b’ ALIMTA.
- if you have recently received or are about to receive a vaccine against yellow fever.
- jekk ħadt dan l- aħħar jew dalwaqt ser tieħu tilqima kontra l- yellow fever.
Take special care with ALIMTA:
Oqgħod attent ħafna b’ ALIMTA:
If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive ALIMTA.
Jekk bħalissa għandek jew fil- passat kellek xi problemi fil- kliewi, kellem lit- tabib tiegħek jew lill - ispiżjar fl- isptar għaliex jista ’ jkun li ma tkunx tista ’ tieħu ALIMTA.
Your doctor may decide to change the dose or put off treating you depending on your general condition and if your blood cell counts are too low.
Qabel kull infużjoni ser jitteħdulek kampjuni tad- demm tiegħek biex jiġi evalwat jekk għandekx funzjoni suffiċjenti tal- kliewi u tal- fwied u jekk għandekx biżżejjed ċelluli tad- demm biex tingħata ALIMTA. It- tabib tiegħek jista ’ jiddeċiedi li jbiddel id- doża jew jipposponi l- kura skond il- kundizzjoni ġenerali tiegħek u jekk l- għadd taċ- ċelluli tad- demm tiegħek ikun baxx wisq.
If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.
Jekk tkun qed tingħata cisplatin ukoll, it- tabib tiegħek ser jara li tkun idratat sew u li tingħata kura xierqa kontra r- rimettar qabel u wara li tingħata cisplatin.
If you have had or are going to have radiation therapy, please tell your doctor.
48 Jekk kellek jew se jkollok kura permezz tar- radjazzjoni, jekk jogħġbok għid lit- tabib tiegħek.
47 If you have been recently vaccinated, please tell your doctor.
Jekk dan l- aħħar ħadt xi tilqim, jekk jogħġbok għid lit- tabib tiegħek.
If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you ALIMTA.
Jekk għandek akkumulazzjoni ta ’ fluwidu madwar il- pulmun tiegħek, it- tabib tiegħek jista ’ jiddeċiedi li jneħħilek dak il- fluwidu qabel ma jagħtik ALIMTA.
If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist.
Jekk tixtieq li ssir missier waqt il- kura jew fis- sitt xhur ta ’ wara li tkun ħadt il- kura, ħu parir mingħand it- tabib tiegħek jew l- ispiżjar tiegħek.
You may want to seek counselling on sperm storage before starting your therapy.
Jista ’ jkun li tkun trid tieħu parir dwar il- ħażna ta ’ sperma qabel ma tibda l- kura.
Taking other medicines Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “ nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor’ s prescription (such as ibuprofen).
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu xi mediċini għall- uġigħ jew għall - infjammazzjoni (nefħa), bħal mediċini msejħa “ mediċini anti- infjammatorji li mhumiex sterojdi ” (NSAIDs), fosthom mediċini li jinxtraw mingħajr riċetta tat- tabib (bħal ibuprofen).
There are many sorts of NSAIDs with different durations of activity.
Hemm ħafna tipi ta ’ NSAIDs b’ tul ta ’ żmien ta ’ attività differenti.
Based on the planned date of your infusion of ALIMTA and/ or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
It- tabib tiegħek jgħidlek liema mediċini tista ’ tieħu u meta tista ’ teħodhom skond id- data ta ’ meta tkun ippjanata l- infużjoni ta ’ ALIMTA u/ jew l- istat tal - funzjoni tal- kliewi tiegħek.
If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Jekk għandek xi dubju, staqsi lit- tabib jew lill- ispiżjar tiegħek jekk xi mediċini li għandek humiex NSAIDs.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy If you are pregnant, or thinking about becoming pregnant, tell your doctor.
Tqala Jekk inti tqila, jew qiegħda taħseb biex tinqabad tqila, għid lit- tabib tiegħek.
The use of ALIMTA should be avoided during pregnancy.
L- użu ta ’ ALIMTA għandu jiġi evitat waqt it- tqala.
Your doctor will discuss with you the potential risk of taking ALIMTA during pregnancy.
It- tabib tiegħek jiddiskuti miegħek dwar ir- riskju potenzjali li tieħu ALIMTA waqt it- tqala.
Women must use effective contraception during treatment with ALIMTA.
In- nisa għandhom jużaw kontraċezzjoni effettiva waqt il- kura b’ ALIMTA.
Breast-feeding If you are breast-feeding, tell your doctor.
Treddigħ Jekk qiegħda tredda ’, għid lit- tabib tiegħek.