qanastek/EMEA-V3 huggingface dataset:
Kepivance may cause increased lipase and amylase levels in some patients with or without symptoms of abdominal pain or backache.
Kepivance jista ’ jikkawża żieda fil- livelli ta ’ lipase u amylase f’ ċertu pazjenti bi jew bla sintomi ta ’ uġigħ addominali jew uġigħ fid- dahar.
The incidences of these changes, presented for Kepivance relative to placebo, were: lipase (28% vs.
L- inċidenza ta ’ dawn il- bidliet b’ Kepivance meta mqabbel mal - plaċebo kienet ta ’: lipase (28% vs.
23%) and amylase (62% vs.
23%) u amylase (62% vs.
No overt cases of pancreatitis have been reported in this patient population.
Ma kienux irrappurtati kazijiet ta ’ pankrejatite li jidhru f’ din il- popolazzjoni ta ’ pazjenti.
Fractionation of increased levels of amylase revealed the increase to be predominantly salivary in origin.
L- analiżi tal- frazzjonijiet tal- livelli miżjuda ta ’ amylase wriet li ż- żieda kienet primarjament ta ’ oriġini salivarja.
Dose limiting toxicities were observed in 36% (5 of 14) patients receiving 6 doses of 80 micrograms/ kg/ day administered intravenously over 2 weeks (3 doses preceding and three doses following myeloablative therapy).
Tossiċitajiet li jillimitaw id- doża kienu osservati f’ 36% (5 minn 14) tal- pazjenti li rċevew 6 dożi ta ’ 80 mikrogramma/ kg/ kuljum mogħtija ġol- vini fuq medda ta ’ ġimagħtejn (3 dożi qabel u 3 dożi wara terapija mijeloablattiva).
These events were consistent with those observed at the recommended dose but were generally more severe.
Dawn l- avvenimenti kienu konsistenti ma ’ dawk osservati bid- doża rakkomandata iżda ġeneralment kienu aktar severi.
The following adverse reactions have been identified during post-marketing use of Kepivance: tongue disorder (e. g. redness, bumps, oedema); face oedema, and mouth oedema; hyperpigmentation of the skin; and anaphylactic/ allergic reactions.
4 Ir- reazzjonijiet avversi li ġejjin ġew identifikati waqt l- użu ta ’ wara t- tqegħid fis- suq ta ’ Kepivance: disturb fl- ilsien (e. ż. ħmura, ponot, edima); edima fil- wiċċ, u edima fil- ħalq; iperpigmentazzjoni tal - ġilda; u reazzjonijiet anafilattiċi/ allerġiċi.
4 4.9 Overdose
4. 9 Doża eċċessiva
There is no experience with Kepivance doses greater than 80 micrograms/ kg/ day administered intravenously in patients over 2 weeks (3 doses preceding and 3 doses following myeloablative therapy).
Ma hemmx esperjenza b’ dożi ta ’ Kepivance ta ’ aktar minn 80 mikrogramma/ kg/ kuljum mogħti ġol - vini f’ pazjenti fuq perjodu ta ’ ġimagħtejn (3 dożi qabel u 3 dożi wara t- terapija mijeloablattiva).
For information on dose limiting toxicities see section 4.8.
Għal tagħrif dwar tossiċitajiet li jillimitaw id- doża ara sezzjoni 4. 8.
A single dose of 250 micrograms/ kg has been administered intravenously to 8 healthy volunteers without severe or serious adverse effects.
Doża waħda ta ’ 250 mikrogramma/ kg ingħatat ġol- vini lil 8 voluntiera b’ saħħithom mingħajr effetti avversi severi jew serji.
Detoxifying agents for antineoplastic treatment, ATC code:
Sustanzi detossifikanti għall- kura antineoplastika, Kodiċi ATC:
Palifermin is a 140 amino acid protein with a molecular weight of 16.3 kilodaltons.
Palifermin huwa proteina b’ 140 amino aċidi b’ piż molekolari ta ’ 16. 3 kilodaltons.
It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve protein stability.
Huwa differenti minn KGF uman endoġenu minħabba li l- ewwel 23 amino aċidi fit- tarf tat- terminali N kienu mneħħija biex itejjbu l- istabilità tal- proteina.
KGF is a protein that targets epithelial cells by binding to specific cell-surface receptors thereby stimulating proliferation, differentiation, and upregulation of cytoprotective mechanisms (eg, induction of antioxidant enzymes).
KGF huwa proteina li għandu bħala mira ċ- ċelloli tal- epitilju billi jeħel ma ’ riċetturi speċifiċi fil- wiċċ taċ- ċelluli u b’ hekk jistimola l- proliferazzjoni, id- divrenzjar, u jżid il- mekkaniżmi ċitoprotettivi (e. ż. l - induzzjoni ta ’ enżimi anti- ossidanti).
Endogenous KGF is an epithelial cell specific growth factor which is produced by mesenchymal cells and is naturally upregulated in response to epithelial tissue injury.
KGF endoġenu huwa fattur tat- tkabbir speċifiku taċ- ċelluli ta ’ l - epitilju li huwa magħmul minn ċelluli mesenkimali, u l- ħelsien tiegħu jiżdied b’ mod naturali b’ respons għall- ħsara fit- tessut ta ’ l- epitilju.
Pharmacology
Farmakoloġija
Epithelial cell proliferation was assessed by Ki67 immunohistochemical staining in healthy subjects.
Proliferazzjoni taċ- ċelluli ta ’ l- epitilju kienet studjata permezz ta ’ kolorazzjoni immunoistokimikali Ki67 f’ soġġetti b’ saħħithom.
A 3-fold or greater increase in Ki67 staining was observed in buccal biopsies from 3 of 6 healthy subjects given palifermin at 40 micrograms/ kg/ day intravenously for 3 days, when measured 24 hours after the third dose.
F’ bijopsiji mill- ħalq kienet osservata żieda ta ’ 3 darbiet jew aktar fil - kolorazzjoni Ki67 f’ 3 minn 6 soġġetti b’ saħħithom li ngħataw 40 mikrogramma/ kg/ kuljum ta ’ palifermin minn ġol- vini għal tlett ijiem, meta mkejjel 24 siegħa wara t- tielet doża.
Dose-dependent epithelial cell proliferation was observed 48 hours post-dosing in healthy subjects given single intravenous doses of 120 to 250 micrograms/ kg.
Proliferazzjoni taċ - ċelluli ta ’ l- epitilju dipendenti mid- doża kienet osservata 48 siegħa wara d- dożaġġ f’ soġġetti b’ saħħithom li ngħataw dożi waħda ta ’ 120 sa 250 mikrogramma/ kg minn ġol- vini.
The palifermin clinical program in the setting of myelotoxic therapy requiring haematopoietic stem cell (HSC) support included 650 patients with haematologic malignancies enrolled in 3 randomised, placebo-controlled clinical studies and a pharmacokinetic study.
Il- programm kliniku ta ’ palifermin fl- ambjent ta ’ terapija mijelotossika il- teħtieġ appoġġ ta ’ ċelluli staminali ematopojetiċi (HSC) inkluda 650 pazjent b’ tumuri malinni ematoloġiċi li ddaħħlu fi 3 studji kliniċi, randomised, ikkontrollati bil- plaċebo u fi studju farmakokinetiku.
Efficacy and safety of palifermin were established in a randomised, double-blind, placebo-controlled study in which patients received high-dose cytotoxic therapy consisting of fractionated total-body irradiation (12 Gy total dose), high-dose etoposide (60 mg/ kg), and high-dose cyclophosphamide (100 mg/ kg) followed by PBPC support for the treatment of haematological malignancies ((Non- Hodgkin’ s Lymphoma (NHL), Hodgkin’ s disease, Acute Myeloid Leukaemia (AML), Acute Lymphocytic Leukaemia (ALL), Chronic Myeloid Leukaemia (CML), Chronic Lymphocytic Leukaemia (CLL), or multiple myeloma).
L- effikaċja u s- sigurtà ta ’ palifermin kienu stabbiliti fi studju randomised, double- blind u kkontrollat bil- plaċebo fejn il- pazjenti rċevew terapija ċitotossika ta ’ doża għolja li kkonsistiet f’ irradjazzjoni frazzjonata tal- ġisem kollu (doża totali ta ’ 12 Gy), doża għolja ta ’ etoposide (60 mg/ kg), u doża għolja ta ’ cyclophosphamide (100 mg/ kg) segwita minn appoġġ b’ PBPC għall- kura ta ’ tumuri malinni ematoloġiċi (Limfoma Mhux ta ’ Hodgkin (NHL), marda ta ’ Hodgkin, Lewkimja Mijelojda Akuta (AML), Lewkimja Limfoċitika Akuta (ALL), Lewkimja Mijelojda Kronika (CML), Lewkimja Limfoċitika Kronika (CLL), jew mijeloma multipla).
In this study, 212 patients were randomised and received either palifermin or placebo.
F’ dan l- istudju, 212- il pazjent kienu randomised u rċevew palifermin jew plaċebo.
Palifermin was administered as a daily intravenous injection of 60 micrograms/ kg for 3 consecutive days prior to initiation of cytotoxic therapy and for 3 consecutive days following infusion of peripheral blood progenitor cells.
5 60 mikrogramma/ kg għal tlett ijiem konsekuttivi qabel il- bidu ta ’ terapija ċitotossika u għal tlett ijiem konsekuttivi wara infużjoni ta ’ ċelluli periferali proġenituri tad- demm.
Other endpoints
Il- mira prinċipali ta ’ l- effikaċja ta ’ l- istudju kienet in- numru ta ’ ġranet li waqthom il- pazjenti esperjenzaw mukosite orali severa (grad 3/ 4 fuq l- iskala ta ’ L- Organizzazzjoni Dinjija tas- Saħħa (WHO)).
5 included the incidence, duration and severity of oral mucositis and the requirement for opioid analgesia.
Miri oħra nkludew l- inċidenza, it- tul u s- severità tal- mukosite orali u l- ħtieġa ta ’ analġesja opjoda.
There was no evidence of a delay in time to haematopoietic recovery in patients who received palifermin as compared to patients who received placebo.
Ma kienx hemm evidenza ta ’ dewmien fil- ħin sa l- irkupru ematopoetiku f’ pazjenti li rċevew palifermin meta mqabbel ma ’ pazjenti li rċevew plaċebo.
The efficacy results are presented in Table 2.
Ir- riżultati ta ’ l- effikaċja huma mniżżla f’ Tabella 2.
Oral mucositis and related clinical sequelae - HSC transplant study
Mukosite orali u konsegwenzi kliniċi relatati – Studju ta ’ trapjant ta ’ HSC
Palifermin (60 micrograms/ kg/ day) n = 106
(60 mikrogramma/ kg/ kuljum) n = 106
Median (25th, 75th percentile) days of WHO Grade 3/ 4 oral mucositis**
Medjan (25th, 75th persentajl) ta ’ ġranet 9 (6, 13) ta ’ mukosite orali ta ’ Grad 3/ 4 skond id- WHO **
Patient incidence of WHO Grade 3/ 4 oral mucositis
Inċidenza ta ’ pazjenti b’ mukosite orali 98% ta ’ Grad 3/ 4 skond id- WHO
Median (25th, 75th percentile) days of WHO Grade 3/ 4 oral mucositis in affected patients
Medjan (25th, 75th persentajl) ta ’ ġranet 9 (6, 13) ta ’ mukosite orali ta ’ Grad 3/ 4 skond (n = 104) (n id- WHO f’ pazjenti affettwati
6 (3, 8) (n = 67)
6 (3, 8) = 67)
Patient incidence of WHO Grade 4 oral 62% mucositis
Inċidenza ta ’ pazjenti b’ mukosite orali 62% ta ’ Grad 4 skond id- WHO
14 (11, 19)
Medjan (25th, 75th persentajl) ta ’ 14 (11, ġranet ta ’ mukosite orali ta ’ Grad 2/ 3/ 4 19) skond id- WHO
Opioid Analgesia for oral mucositis:
Analġesja Opjoda għall- mukosite 11 (8, 14) 7 orali:
Median (25th, 75th percentile) Days
Medjan (25th, 75th persentajl) Ġranet
7 (1, 10)
(1, 10)
Median (25th, 75th percentile) Cumulative Dose (morphine mg equivalents)
Medjan (25th, 75th persentajl) Doża Kumulattiva (ekwivalenti għal morphine mg)
Patient Incidence of Total Parenteral Nutrition (TPN)
Inċidenza ta ’ Pazjenti b’ Nutrizzjoni Parenterali Totali (TPN)
* Using Cochran-Mantel-Haenszel (CMH) test stratified for study centre. ** WHO Oral Mucositis Scale:
* Bl- użu tat- test Cochran- Mantel- Haenszel (CMH) stratifikat għaċ- ċentru ta ’ l- istudju. ** Skala tal- Mukosite Orali skond id- WHO:
Grade 1 = soreness/ erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible
Grad 1 = uġigħ/ eritema; Grad 2 = eritema, ulċeri, ħila li tiekol ikel solidu; Grad 3 = ulċeri, teħtieġ dieta ta ’ likwidi biss; Grad 4 = mhux possibli li tiekol
In this Phase 3 clinical study, palifermin treated patients demonstrated significant benefits in patient-reported outcomes of mouth and throat soreness and its impact on swallowing, drinking, eating and talking.
F’ dan l- istudju kliniku ta ’ Fażi 3, pazjenti kkurati b’ palifermin urew benefiċċji sinifikanti fir- riżultati irrappurtati mill- pazjenti ta ’ uġigħ tal- ħalq u tal- griżmejn u l- effett tiegħu fuq il- ħila biex tibla ’, tixrob, tiekol u titkellem.
These patient-reported outcomes were highly correlated to the clinician grading of oral mucositis using the WHO scale.
Dawn ir- riżultati rrappurtati mill- pazjenti kienu korrelati ħafna mal- gradazzjoni tal - mukosite orali bl- użu ta ’ l- iskala tad- WHO.
The pharmacokinetics of palifermin were studied in healthy volunteers and patients with haematological malignancies.
Il- farmakokinetika ta ’ palifermin kienet studjata f’ voluntiera b’ saħħithom u pazjenti b’ tumuri malinni ematoloġiċi.
After single intravenous doses of 20 to 250 micrograms/ kg (healthy volunteers) and 60 micrograms/ kg (cancer patients), palifermin exhibited rapid extravascular distribution In patients with haematological malignancies mean Vss was 5 l/ kg and mean clearance about 1300 ml/ hour/ kg with an average terminal half-life of approximately 4.5 hours.
Wara dożi singulari ġol- vini ta ’ 20 sa 250 mikrogramma/ kg (voluntiera b’ saħħithom) u 60 mikrogramma/ kg (pazjenti bil- kanċer), palifermin wera distribuzzjoni ekstravaskulari mgħaġġla.
Approximately dose-linear pharmacokinetics were observed in healthy volunteers after single dose administration up to 250 micrograms/ kg.
F’ pazjenti b’ tumuri malinni ematoloġiċi il- medja ta ’ Vss kien 5 l/ kg u t- tneħħija medja kienet madwar 1300 ml/ siegħa/ kg b’ medja tal- half- life terminali ta ’ madwar 4. 5 siegħat.
No accumulation of palifermin occurred after 3 consecutive daily doses of 20 and 40 micrograms/ kg (healthy volunteers) or 60 micrograms/ kg (cancer patients).
Ma dehret l- ebda akkumulazzjoni ta ’ palifermin wara 3 dożi konsekuttivi ta ’ kuljum ta ’ 20 u 40 mikrogramma/ kg (voluntiera b’ saħħithom) jew 60 mikrogramma/ kg (pazjenti bil - kanċer).
Inter-subject variability is high with a CV% of about 50% for CL and 60% for Vss
Il- varjabilità bejn is- soġġetti hija għolja b’ CV% ta ’ madwar 50% għal CL u 60% għal Vss.
No gender-related differences were observed in the pharmacokinetics of palifermin.
Ma kienet osservata l- ebda differenza relatata mas- sess fil- farmakokinetika ta ’ palifermin.
Mild to moderate renal impairment (creatinine clearance 30-80 ml/ min) did not influence palifermin pharmacokinetics.
Indeboliment renali ħafif għal moderat (tneħħija ta ’ krejatinina ta ’ 30- 80 ml/ min) ma influwenzatx il - farmakokinetika ta ’ palifermin.
In patients with severe renal impairment (creatinine clearance < 30 ml/ min), clearance was decreased by 22% (n=5).
F’ pazjenti b’ indeboliment renali sever (tneħħija ta ’ krejatinina < 30 ml/ min), it- tneħħija kienet mnaqqsa b’ 22% (n=5).
In patients with end-stage renal disease (requiring dialysis) palifermin clearance was
F’ pazjenti b’ marda renali ta ’ l- aħħar stadju (li teħtieġ id- dijalisi) t- tneħħija ta ’ palifermin kienet mnaqqsa b’ 10% (n=6).
The pharmacokinetic profile in paediatric and geriatric populations (age above 70 years), or in patients with hepatic insufficiency, has not been assessed.
Il- profil farmakokinetiku f’ popolazzjonijiet pedjatriċi u ġerjatriċi (età ’ l fuq minn 70 sena), jew f’ pazjenti b’ insuffiċjenza epatika, ma ġiex stmat.
Salient findings in toxicology studies in rat and monkey were generally attributable to the pharmacological activity of palifermin, specifically, proliferation of epithelial tissues.
Is- sejbiet prinċipali ta ’ l- istudji tossikoloġiċi fil- far u x- xadina kienu ġeneralment attribwiti għal l - attività farmakoloġika ta ’ palifermin, speċifikatament, il- proliferazzjoni tat- tessuti ta ’ l- epitilju.
In fertility/ general reproductive toxicity studies in rats, palifermin treatment was associated with systemic toxicity (clinical signs and/ or changes in body weight) and adverse effects on male and female reproductive/ fertility parameters at doses greater than or equal to 300 micrograms/ kg/ day.
Fi studji dwar it- tossiċità fuq il- fertilità u l- funżjoni riproduttiva ġenerali fil- firien, kura b’ palifermin kienet assoċjata ma ’ tossiċità sistemika (sinjali kliniċi u/ jew tibdil fil- piż tal- ġisem) u effetti avversi fuq il- parametri tar- riproduzzjoni u tal- fertilità maskili u femminnili f’ dożi akbar minn jew ugwali għal 300 mikrogramma/ kg/ kuljum.
No adverse effects on reproductive/ fertility parameters were observed at doses of up to 100 micrograms/ kg/ day.
Ma kienu osservati l- ebda effetti avversi fuq il- parametri tar - riproduzzjoni u tal- fertilità f’ dożi ta ’ mhux aktar minn 100 mikrogramma/ kg/ kuljum.
These no observed adverse effect level (NOAEL) doses were associated with systemic exposures up to 2.5 times greater than anticipated clinical exposure.
Dawn il- livelli ta ’ doża mingħajr l- ebda effetti avversi osservati (NOAEL) kienu assoċjati ma ’ esponimenti sistemiċi sa 2. 5 darbiet aktar mill- esponiment kliniku mistennija.
In embryo/ foetal development toxicity studies in rats and rabbits, palifermin treatment was associated with developmental toxicity (increased post-implantation loss, reduced litter size, and/ or reduced foetal weight) at doses of 500 and 150 micrograms/ kg/ day, respectively.
Fi studji dwar it- tossiċità fuq l- embriju u fuq l- iżvilupp tal- fetu fil- firien u fniek, kura b’ palifermin kienet assoċjata ma ’ tossiċità fuq l- iżvilupp (żieda fit- telf wara l- implantazzjoni, boton ta ’ daqs imnaqqas, u/ jew tnaqqis fil- piż tal- fetu) f’ dożi ta ’ 500 u 150 mikrogramma/ kg/ kuljum, rispettivament.
Treatment with these doses was also associated with maternal effects (clinical signs and/ or changes in body weight/ food consumption), suggesting that palifermin was not selectively toxic to development in either species.
Kura b’ dawn id- dożi kienet assoċjata wkoll ma ’ effeti fuq l- omm (sinjali kliniċi u/ jew bidliet fil- piż tal- ġisem/ konsum ta ’ l- ikel), li jissuġġerixxi li palifermin ma kienx tossiku b’ mod selettiv għall - iżvilupp fiż- żewġ speċi.
No adverse developmental effects were observed in rats and rabbits at doses of up to 300 and 60 micrograms/ kg/ day, respectively.
Ma kienu osservati l- ebda effetti avversi fuq l- iżvilupp fil- firien u fniek f’ dożi sa 300 u 60 mikrogramma/ kg/ kuljum, rispettivament.
These NOAEL doses were associated with systemic exposures (based on AUC) up to 9.7 and 2.1 times, respectively, anticipated clinical exposure.
Dawn id- dożi NOAEL kienu assoċjati ma ’ esponimenti sistemiċi (ibbażati fuq l- AUC) sa 9. 7 u 2. 1 darbiet, rispettivament, l- esponiment kliniku mistenni.
Peri- and postnatal development has not been studied.
Żvilupp waqt u wara t- twelid ma ġiex studjat.
Palifermin is a growth factor that primarily stimulates epithelial cells through the KGF receptor.
Palifermin huwa fattur ta ’ tkabbir li primarjament jistimola iċ- ċelluli ta ’ l- epitilju permezz tar- riċettur għal KGF.
Haematologic malignancies do not express the KGF receptor.
Tumur malinni ma jkollomx ir- riċettur għal KGF.
However, patients treated with chemotherapy and/ or radiotherapy are at higher risk of developing secondary tumours some of which may express KGF receptors, and theoretically, be stimulated by KGF receptor ligands.
Iżda, pazjenti kkurati b’ kemjoterapija u/ jew radjuterapija huma f’ riskju akbar li jiżviluppaw tumuri sekondarji li wħud minnhom jista ’ jkollhom riċetturi għal KGF, u teoretikament, jiġu stimolati mill- ligandi tar- riċetturi ta ’ KGF.
In a study to assess potential carcinogenicity in transgenic rasH2 mice, no treatment related increases in the incidence of neoplastic lesions were observed.
Fi studju biex jivvaluta il- karċinoġeniċità potenzjali fi ġrieden transġeniċi rasH2, ma kienu osservati l- ebda żiediet relatati mal- kura fl- inċidenza ta ’ leżjonijiet nejoplastiċi.
L-histidine Mannitol Sucrose Polysorbate 20 Diluted Hydrochloric acid
L- histidine Mannitol Sucrose Polysorbate 20 Hydrochloric acid dilwit
If heparin is used to maintain an intravenous line, sodium chloride solution should be used to rinse the line prior to and after Kepivance administration, since palifermin has been shown to bind to heparin in vitro.
7 Jekk eparina tintuża biex jinżamm pajp ġol- vina, għandha tintuża soluzzjoni ta ’ sodium chloride biex jitlaħlaħ il- pajp qabel u wara għotja ta ’ Kepivance, minħabba li palifermin intwera li jeħel ma ’ l - eparina in vitro.
7 After reconstitution:
Wara r- rikostituzzjoni:
24 hours at 2°C - 8°C, protected from light.
24 siegħa f’ temperatura ta ’ 2°C - 8°C, protett mid- dawl.
Store in original package in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
6.25mg of powder in a vial (Type I glass) with a rubber stopper, an aluminium seal and a plastic flip- off cap.
6. 25mg trab f’ kunjett (ħġieġ tat- Tip I) b’ tapp tal- lasktu, siġill tal- aluminju u għatu flip- off tal- plastik.
Carton containing 6 vials.
Kartuna fiha 6 kunjetti.
Kepivance is a sterile but unpreserved product and is intended for single use only.
Kepivance huwa prodott sterili iżda mingħajr preservattivi u huwa maħsub għall- użu ta ’ darba biss.
Kepivance should be reconstituted with 1.2 ml water for injections.
Kepivance għandu jiġi rikostitwit b’ 1. 2 ml ilma għall- injezzjonijiet.
The diluent should be injected slowly into the Kepivance vial.
Id- dilwent għandu jiġi njettat bil - mod fil- kunjett ta ’ Kepivance.
The contents should be swirled gently during dissolution.
Il- kontenut għandu jiddawwar bil- mod waqt id- dissoluzzjoni.
Do not shake or vigorously agitate the vial.
Tħawwadx jew tħallatx il- kunjett bis- saħħa.
Generally, dissolution of Kepivance takes less than 5 minutes.
Ġeneralment, id- dissoluzzjoni ta ’ Kepivance tieħu inqas minn 5 minuti.
Visually inspect the solution for discolouration and particulate matter before administration.
Ispezzjoni b’ mod viżwali is - soluzzjoni għal bidliet fil- kulur jew frak li jidher qabel l- għotja.
Kepivance should not be administered if discolouration or particulates are observed.
Kepivance m’ għandu jingħata jekk tkun osservata bidla fil- kulur jew frak li jidher.
Before injection‚ Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light.
Qabel l- injezzjoni, Kepivance jista ’ jitħalla jilħaq it- temperatura tal- kamra għal massimu ta ’ siegħa iżda għandu jiġi protett mid- dawl.
Kepivance left at room temperature for more than 1 hour should be discarded.
Kepivance li jitħall fit- temperatura tal- kamra għal aktar minn siegħa għandu jintrema.
Biovitrum AB (publ) SE-112 76 Stockholm Sweden
Biovitrum AB (publ) SE- 112 76 Stockholm L- Isvezja
8 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
10 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Amgen Inc 5550 Airport Boulevard Boulder, Colorado 80301 United States of America
Amgen Inc 5550 Airport Boulevard Boulder, Colorado 80301 L- Istati Uniti
Amgen Inc 4000 Nelson Road Longmont, Colorado 80503 United States of America
Amgen Inc 4000 Nelson Road Longmont, Colorado 80503 L- Istati Uniti
Minervum 7061 4817 ZK Breda The Netherlands
Minervum 7061 4817 ZK Breda L- Olanda
Kepivance 6.25 mg powder for solution for injection Palifermin
Kepivance 6. 25 mg trab għal soluzzjoni għall- injezzjoni Palifermin
L-histidine, mannitol, sucrose, polysorbate 20 and diluted hydrochloric acid
L- histidine, mannitol, sucrose, polysorbate 20 u hydrochloric acid dilwit
6 vials containing powder for solution for injection
6 kunjetti li fihom trab għal soluzzjoni għall- injezzjoni
For intravenous use For single use only Read the package leaflet before use
Użu għal ġol- vini Użu ta ’ darba biss Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Store in a refrigerator.
Aħżen fi friġġ (2°C - 8°C).
Once reconstituted, store in a refrigerator and use within 24 hours.
Ladarba jiġi rikostitwit, aħżen fi friġġ u uża f’ 24 siegħa.
Medicinal product subject to medical prescription
Prodott mediċinali li jingħata bir- riċetta tat- tabib.
Kepivance 6.25 mg powder for injection Palifermin
Kepivance 6. 25 mg trab għall- injezzjoni Palifermin
Kepivance 6.25 mg powder for solution for injection palifermin
Kepivance 6. 25 mg trab għal soluzzjoni għall- injezzjoni palifermin
If you have further questions, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Kepivance is and what it is used for 2.
X’ inhu Kepivance u għalxiex jintuża 2.
Before you use Kepivance 3.
Qabel ma tuża Kepivance 3.
How to use Kepivance 4.
Kif għandek tuża Kepivance 4.
Possible side effects 5 How to store Kepivance 6.
Kif taħżen Kepivance 6.
WHAT KEPIVANCE IS AND WHAT IT IS USED FOR
X’ INHU KEPIVANCE U GĦALXIEX JINTUŻA
Kepivance should only be used in adults over the age of 18 years.
Kepivance għandu jintuża biss minn adulti b’ età ’ l fuq minn 18- il sena.
Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli.
Kepivance fih is- sustanza attiva palifermin li hija proteina magħmula minn bioteknoloġija f’ batterja msejħa Escherichia coli.
Palifermin is similar to the protein called keratinocyte growth factor (KGF) that is naturally made by your body in small amounts.
Palifermin huwa simili għall- proteina msejħa fattur tat- tkabbir tal - keratinoċiti (KGF) li huwa magħmul b’ mod naturali mill- ġisem tiegħek fi kwantitajiet żgħar.
Palifermin acts in the same way as naturally occurring KGF by stimulating the growth of specific cells called epithelial cells that form the tissue lining of your mouth and digestive tract, as well as other tissues such as skin.
Palifermin jaħdem fl- istess mod bħal KGF magħmul b’ mod naturali, billi jistimola t- tkabbir ta ’ ċelluli speċifiċi msejjħa ċelluli ta ’ l- epitilju li jiffurmaw it- tessut tal- kisja f’ ħalqek u fl- appart gastro - intestinali tiegħek, kif ukoll f’ tessuti oħra bħall- ġilda.
Kepivance is used to reduce the frequency, duration and severity of oral mucositis (soreness, dryness and inflammation of the mouth) and improve related symptoms in patients with haematological malignancies (blood cancers) receiving certain types of chemotherapy and/ or radiotherapy requiring autologous haematopoietic stem cell support (cells from your own body that produce blood).
Kepivance jintuża biex inaqqas il- frekwenza, d- dewmien u s- severità ta ’ mukosite orali (uġigħ, ħalq xott u infjammat) u biex itejjeb is- sintomi relatati f’ pazjenti b’ tumuri malinni ematoloġiċi (kanċer fid - demm) li qed jirċievu ċertu tipi ta ’ kemjoterapija u/ jew radjuterapija li teħtieġ appoġġ ta ’ ċelluli staminali ematopojetiċi awtologi (ċelluli mill- ġisem tiegħek stess li jipproduċu d- demm).
BEFORE YOU USE KEPIVANCE
QABEL MA TUŻA KEPIVANCE
Do not use Kepivance:
Tużax Kepicvace:
• if you are allergic (hypersensitive) to palifermin‚ any other ingredients of Kepivance, or to Escherichia coli derived proteins.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal palifermin jew sustanzi oħra ta ’ Kepivance, jew għal xi proteini ġejjin minn Escherichia coli
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed to you by a doctor.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
18 Pregnancy and breast-feeding
18 Tqala u Treddigħ
Kepivance has not been tested in pregnant women.
Kepivance ma ġiex ittestjat f’ nisa tqal.
It is important to tell your doctor if you:
Huwa mportanti li tgħid lit- tabib tiegħek jekk:
• are pregnant;
• inti tqila;
• think you may be pregnant; or
• taħseb li tista ’ tkun tqila; jew
• plan to get pregnant.
• qed tippjana li toħroġ tqila.
It is not known whether Kepivance is present in human milk.
Mhux magħruf jekk Kepivance jinstabx fil- ħalib uman.
Do not use Kepivance if you are breast- feeding.
Tużax Kepivance jekk qed tredda ’.
The effect of Kepivance on the ability to drive or use machinery is not known.
L- effett ta ’ Kepivance fuq il- ħila biex issuq jew tħaddem magni mhux magħruf.
HOW TO USE KEPIVANCE
KIF GĦANDEK TUŻA KEPIVANCE
As Kepivance is a powder it must be mixed with water for injections before being injected into a vein.
Minħabba li Kepivance huwa trab dan għandu jitħallat ma ’ ilma għall- injezzjonijiet qabel ma jiġi njettat ġo vina.
The usual dose is 60 micrograms of Kepivance per kilogram of bodyweight per day.
Id- doża tas- soltu hija 60 mikrogamma ta ’ Kepivance kull kilogramma ta ’ piż tal- ġisem kuljum.
This is given as an intravenous injection (into a vein) for three days in a row before chemotherapy and/ or radiotherapy and three days in a row after chemotherapy and/ or radiotherapy for a total of six doses.
Dan jingħata bħala injezzjoni ġol- vini (ġo vina) għal tlett ijiem wara xulxin qabel kemjoterapija u/ jew radjuterapija u tlett ijiem wara xulxin wara kemjoterapija u/ jew radjuterapija għal total ta ’ sitt dożi.
Kepivance left at room temperature for more than 1 hour must be disposed of.
Kepivance li jitħalla fit- temperatura tal- kamra għal aktar minn siegħa għandu jintrema.
Do not shake Kepivance.
Tħawwadx Kepivance.
Like all medicines, Kepivance can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Kepivance jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common (more than 1 in every 10 patients) side effects are: • skin rash, itching and redness (pruritus and erythaema); • an increase in the thickness in the mouth or tongue; • change in colour of the mouth or tongue; • generalised swelling (oedema); • pain; • fever; • aching joints (arthralgia); and • altered taste.
Effetti sekondarji komuni ħafna (aktar minn 1 minn kull 10 pazjenti) huma: • raxx fil- ġilda; • ħakk u ħmura (ħakk u eritema); • żieda fil- ħxuna tal- ħalq jew tal- ilsien; • bidla fil- kulur tal- ħalq jew tal- ilsien; • nefħa ġeneralizzata (edima); • uġigħ; • deni; • uġigħ fil- ġogi (artralġja); u • bidla fit- togħma.
Other side effects seen in patients are: • redness, bumps or swelling of the tongue; • swelling (oedema) of the face or mouth; • darkening of an area of skin (hyperpigmentation); and • allergic reactions.
Effetti sekondarji oħra li dehru fil- pazjenti huma: • ħmura, ponot jew nefħa fl- ilsien; • nefħa (edima) tal- wiċċ jew ħalq; • erja tal- ġilda tiskura (iperpigmentazzjoni); u • reazzjonijiet allerġiċi.
19 Some patients have had an increase in lipase and amylase levels (digestive enzymes) in their blood, which do not require treatment and usually return to normal after stopping treatment with Kepivance.
19 Uħud mill- pazjenti kellhom żieda fil- livelli ta ’ lipase u amylase (enżimi diġestivi) fid- demm tagħhom, li ma jinħtieġux kura u ġeneralment jirritornaw għan- normal wara li titwaqqaf il- kura b’ Kepivance.
HOW TO STORE KEPIVANCE
KIF TAĦŻEN KEPIVANCE
Do not use Kepivance after the expiry date which is stated on the carton and vial label, after EXP.
Tużax Kepivance wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- kunjett, wara JIS.
Store in the original carton, in order to protect from light.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
What Kepivance contains
X’ fih Kepivance:
The active substance is palifermin.
Is- sustanza attiva hi palifermin.
The other ingredients of Kepivance are mannitol, sucrose, L-histidine, polysorbate 20 and diluted hydrochloric acid.
Is- sustanzi l- oħra ta ’ Kepivance huma mannitol, sucrose, L- histidine, polysorbate 20 u hydrochloric acid dilwit.
What Kepivance looks like and contents of the pack
Id- Dehra ta ’ Kepivance u l- kontenuti tal- pakkett:
Kepivance is a white powder supplied in vials.
Kepivance huwa trab abjad disponibbli f’ kunjetti.
Each pack contains 6 vials.
Kull pakkett fih 6 kunjetti.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
20 Kepivance should be reconstituted with 1.2 ml water for injections.
Kepivance għandu jiġi rikostitwit b’ 1. 2 ml ilma għall- injezzjonijiet.
The contents should be swirled gently during dissolution.
Il- kontenuti għandhom jiddawru bil- mod waqt id- dissoluzzjoni.
Do not shake or vigorously agitate the vial.
Tħawwadx jew iċċaqlaqx bis- saħħa il- kunjett.
Generally, dissolution of Kepivance takes less than 5 minutes.
20 Ġeneralment, id- dissoluzzjoni ta ’ Kepivance tieħu inqas minn 5 minuti.
Visually inspect the solution for discolouration and particulate matter before administration.
Ispezzjona b’ mod viżwali is - soluzzjoni għal bidla fil- kulur jew frak li jidher qabel l- għotja.
Kepivance should not be administered if discolouration or particulates are observed.
Kepivance m’ għandux jingħata jekk tkun osservata bidla fil- kulur jew frak li jidher.
Kepivance left at room temperature for more than 1 hour should be discarded.
Kepivance li jitħalla fit- temperatura tal- kamra għal aktar minn siegħa għandu jintrema.
European Medicines Agency
Aġenzija Ewropea tal- Mediċini
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jagħti r- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tal- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Keppra?
X’ inhi Keppra?
Keppra is a medicine containing the active substance levetiracetam.
Keppra hija mediċina li fiha levetiracetam bħala s- sustanza attiva.
It is available as oblong tablets (blue:
Din tiġi bħala pilloli tawwalin (blu:
250 mg; yellow:
250 mg; sofor:
500 mg; orange:
500 mg; oranġjo:
750 mg; white:
750 mg; bojod:
1000 mg), as an oral solution (100 mg/ ml), and as a concentrate to be made up into a solution for infusion (drip into a vein, 100 mg/ ml).
1000 mg), bħala soluzzjoni orali (100 mg/ ml), u bħala konċentrat li jinbiddel f’ soluzzjoni għall- infużjoni (dripp f’ vina, 100 mg/ ml).
What is Keppra used for?
Għalxiex tittieħed Keppra?
Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures (fits) with or without secondary generalisation.
Keppra tista ’ tittieħed waħedha minn pazjenti minn 16- il sena ’ l fuq, li jkunu għadhom kif ġew iddijanjostikati bl- epilessija, sabiex tfejjaq attakki qawwija ta ’ puplesija parzjali (fits) b’ ġeneralizzazzjonijiet sekondarji jew mingħajrhom.
This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell, or vision, numbness or a sudden sense of fear.
Din hija tip ta ’ epilessija fejn attività elettrika żejda fuq naħa waħda tal- moħħ tikkawża sintomi bħal moviment bl- iskossi f’ daqqa f’ parti waħda tal - ġisem, nuqqas ta ’ smigħ, xamm u vista, tirżiħ u sens ta ’ biża f’ daqqa.
Secondary generalisation occurs when the overactivity later reaches the whole brain.
Meta l- attività żejda tilħaq il - moħħ kollu, jkun hemm ġeneralizzazzjoni sekondarja.
Keppra can also be used as adjunctive therapy in patients who already receive other anti-epileptic medicines to treat: • partial onset seizures with or without generalisation in patients from four years of age, • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy, • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Keppra tista ’ tintuża wkoll bħala terapija addizzjonali f’ pazjenti li diġà jirċievu mediċini kontra l - epilessija biex tikkura: • attakki qawwija ta ’ puplesija parzjali b’ ġeneralizzazzjoni jew le f’ pazjenti minn erba ’ snin ’ il fuq, • myoclonic seizures (qosra, skossi qishom xokkijiet fil- muskolu jew fi grupp ta ’ muskoli) f’ pazjenti minn 12- il sena ’ l fuq b’ epilessija mijoklonika tat- tfal, • attakki qawwija ta ’ puplesija tonic- clonic primarji u ġeneralizzati (attakki qawwijin, inkluż it - telf mis- sesni) f’ pazjenti minn 12- il sena ’ l fuq b’ epilessija idjopatika ġeneralizzata (it- tip ta ’ epilessija li hi maħsuba li hi ġenetika).
How is Keppra used?
Kif tintuża Keppra?
When Keppra is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Meta Keppra tintuża waħedha, id- doża inizjali hi ta ’ 250 mg darbtejn kuljum, u wara ġimagħtejn din tiżdied għal 500 mg darbtejn kuljum.
The dose can be further increased at two-week intervals according to the patient’ s response, to a maximum dose of 1,500 mg twice a day.
Id- doża tista ’ tiżdied kull ġimagħtejn skond ir- reazzjoni tal - pazjent sad- doża massima ta ’ 1, 500 mg darbtejn kuljum.
When Keppra is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Meta Keppra tingħata flimkien ma ’ trattament ieħor kontra l- epilessija, id- doża inizjali f’ pazjenti ’ l fuq minn 12- il sena b’ piż iktar minn 50 kg hija ta ’ 500 mg darbtejn kuljum.
The daily dose can be increased up to 1,500 mg twice a day.
Id- doża ta ’ kuljum tista ’ tiżdied għal 1, 500 mg darbtejn kuljum.
In children aged four 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/ kg twice a day.
Fi tfal ta ’ bejn l- erba ’ u s- 16- il sena b’ piż inqas minn 50 kg, id - doża inizjali hija ta ’ 10 mg għal kull kilogramma ta ’ piż darbtejn kuljum, li tista ’ tiżdied għal 30 mg/ kg darbtejn kuljum.
The oral solution is recommended when starting treatment in children weighing less than 20 kg.
Is- soluzzjoni orali hija rakkomandata meta jibda t- trattament fi tfal li jiżnu inqas minn 20 kg.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Lower doses are used in patients who have problems with their kidneys (such as older patients).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged F’ pazjenti bi problemi (bħal pazjenti ikbar fl- età) jintużaw dożi iktar baxxi.
Keppra tablets may be taken with or without food and are swallowed with liquid.
Il- pilloli ta ’ Keppra, jistgħu jittieħdu fuq l- ikel jew fuq xejn u jinbelgħu ma ’ xi likwidu.
The oral solution may be mixed in a glass of water before taking.
Is- soluzzjoni orali tista ’ titħallat ma ’ tazza ilma qabel ma tittieħed.
Keppra can be given as an infusion using the same doses at the same frequency when the use of the tablets or the oral solution is temporarily not possible.
Meta l- użu tal- pilloli u s- soluzzjoni orali jkun temporanjament impossibli, Keppra tista ’ tingħata bħala infużjoni bl- istess doża u frekwenza.
How does Keppra work?
Kif taħdem Keppra?
The active substance in Keppra, levetiracetam, is an anti-epileptic medicine.
Is- sustanza attiva f’ Keppra, levetiracetam, hija mediċina kontra l- epilessija.
Epilepsy is caused by excessive electrical activity in the brain.
L- epilessija hija kkawżata b’ attività elettronika eċċessiva fil- moħħ.
The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called the synaptic vesicle protein 2A, which is found in the space between nerves (synapses) and stops the release of chemical messengers between nerve cells.
Il- mod eżatt ta ’ kif jaħdem levetiracetam għadu mhux ċar iżda jidher li jfixkel proteina msejħa synaptic vesicle protein 2A, li tinsab fl- ispazju ta ’ bejn in - nervituri (synapses) u twaqqaf ir- rilaxx ta ’ messaġġiera kimiċi fiċ- ċelluli tan- nervi.
This helps Keppra to stabilise electrical activity in the brain and prevent seizures.
Dan jgħin lil Keppra sabiex tistabbilizza l- attività elettronika fil- moħħ u twaqqaf l- attakki ta ’ puplesija.
How has Keppra been studied?
Kif ġiet studjata Keppra?
The effectiveness of Keppra as an add-on treatment in partial onset seizures has been studied in three main studies in a total of 904 patients.
L- effikaċja ta ’ Keppra bħala trattament addizzjonali f’ attakki ta ’ puplesija parzjali, ġiet studjata fi tliet studji prinċipali f’ total ta ’ 904 pazjent.
All patients were taking at least one other anti-epileptic medicine.
F’ dawn l- istudji, Keppra f’ dożi ta ’ 1, 000, 2, 000 or 3, 000 mg kuljum, ġiet imqabbla ma ’ plaċebo (trattament finta) fuq perjodu minn 12 sa 14- il ġimgħa.
In all studies, the main measure of effectiveness was the reduction in weekly partial seizure rate.
Fl- istudji kollha, il- miżura ewlenija ta ’ l- effettività kienet it- tnaqqis fir- rata ta ’ puplesija parzjali fil- ġimgħa.
In myoclonic seizures, the effectiveness of Keppra was studied in 122 patients, who received either Keppra or placebo in addition to their normal anti-epileptic medicine.
F’ myoclonic seizures, l- effikaċja ġiet studjata f’ 122 pazjent li rċevew jew Keppra jew plaċebo flimkien mal- mediċina normali tagħhom kontra l- epilessija.
The study lasted up to 30 weeks, and looked at the seizure rates before and during the study to see if they had decreased.
L- istudju dam 30 ġimgħa u ta ħarsa lejn ir- rati ta ’ puplesija kemm qabel kif ukoll waqt l- istudju sabiex jara jekk dawn naqsux.
In primary generalised tonic-clonic seizures, the effectiveness of Keppra was compared with that of placebo in 164 patients aged between four and 65 years.
F’ seizures tonic- clonic ġeneralizzati, l- effikaċja ta ’ Keppra ġiet imqabbla ma ’ dik tal- plaċebo f’ 164 pazjent ta ’ bejn l- erba ’ u l- 65 sena.
The study looked at the change in seizure rate between the start of the study and the 20-week period when the patients were taking their full dose.
L- istudju ta ħarsa lejn il- bidla fir- rata ta ’ puplesija bejn il- bidu ta ’ l- istudju u l- perjodu ta ’ 20 ġimgħa fejn il- pazjenti kienu qed jieħdu d- doża sħiħa.
The effectiveness of Keppra used on its own was studied in 579 patients, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years.
L- effikaċja ta ’ Keppra meħuda waħidha ġiet studjata f’ 579 pazjent li rċevew Keppra jew carbamazepine (mediċina oħra kontra l- epilessija) sa perjodu ta ’ sentejn.
The study measured how many patients remained free of seizures for six months once they had reached their effective dose.
L- istudju kejjel kemm kien hemm pazjenti li ma tathomx puplesija għal sitt xhur wara li rċevew id- doża effettiva tagħhom.
What benefit has Keppra shown during the studies?
X’ kienu l- benefiċċji ta ’ Keppra nnutati waqt l- istudji?
As add-on treatment, Keppra was more effective than placebo.
Bħala trattament addizzjonali, Keppra kienet iktar effettiva mill- plaċebo.
For partial onset seizures, placebo treatment reduced the weekly seizure rate by 6.1% to 7.2%, while the reduction with Keppra at a dose of 1000 mg/ day was between 17.7% and 32.5%, depending on the study.
Fil- każ ta ’ attakki qawwija ta ’ puplesija, il- plaċebo naqqas ir- rata ta ’ attakki ta ’ puplesija fil- ġimgħa b’ 6. 1% sa 7. 2%, filwaqt li t - tnaqqis permezz ta ’ Keppra f’ doża ta ’ 1000 mg kuljum kien bejn 17. 7% u 32. 5%, skond l- istudju.
With Keppra at a dose of 2000 mg, the reduction was 26.5%, and with 3000 mg, it was 37.1 or 39.9%.
B’ Keppra f’ doża ta ’ 2000 mg, it- tnaqqis kien ta ’ 26. 5%, u bi 3000 mg, kien ta ’ 37. 1% jew 39. 9%.
In the study in children, the reduction in weekly seizure rate was 43.3% in the group of children who received Keppra, and 16.3% in the placebo group.
Fl - istudju fuq it- tfal, ir- rata ta ’ tnaqqis ta ’ puplesija fil- ġimgħa kien ta ’ 43. 3% fil- grupp ta ’ tfal li rċevew Keppra, u 16. 3% fil- grupp li rċevew plaċebo.
For myoclonic seizures, 58.3% of the patients who received Keppra had at least a halving of the number of seizure days per week, compared with 23.3% of the patients who received placebo.
Għall- myoclonic seizures, 58. 3% tal- pazjenti li rċevew Keppra kellhom in- numru tal- ġranet li fihom tawhom puplesiji imnaqqsa ta ’ l- inqas bin- nofs meta mqabbel mat- 23. 3% tal- pazjenti li rċevew il- plaċebo.
For tonic-clonic seizures, there was an average reduction in seizure rate of 28.2% in the patients taking placebo, compared with 56.5% in those taking Keppra.
Fil- każ ta ’ tonic- clonic seizures, kien hemm tnaqqis medju ta ’ 28. 2% fir- rata ta ’ puplesija fil- pazjenti li ħadu l- plaċebo meta mqabbel mal- 56. 5% f’ dawk li ħadu Keppra.
However, there were too few children aged below 12 to support the use of Keppra for this type of seizure in patients below this age.
Madankollu, kien hemm ftit wisq tfal inqas minn 12- il sena sabiex jiġi sostnut l- użu ta ’ Keppra għal puplesija ta ’ dan it- tip f’ pazjenti taħt din l- età.
Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizures.
Meta ttieħdet waħedha għall- attakki qawwijin ta ’ puplesija parzjali, Keppra kienet effettiva daqs carbamazepine sabiex tħalli lill- pazjenti liberi minn puplesiji.
In both groups, 73% of patients experienced no seizures for six months once on an adequate dose.
Fiż- żewġ gruppi, 73% tal- pazjenti ma esperjenzawx puplesija waħda għal sitt xhur meta ngħataw doża adegwata.
What is the risk associated with Keppra?
X’ inhu r- riskju assoċjat ma ’ Keppra?
The most common side effects with Keppra (seen in more than 1 patient in 10) are somnolence (sleepiness) and asthenia (weakness) or fatigue (tiredness).
L- aktar effetti sekondarji komuni ta ’ Keppra (innutati f’ aktar minn pazjent 1 minn 10) huma ħedla ta ’ rqad (xejra tan- ngħas) u astenja (debbulizza) jew għeja kbira (għeja).
For the full list of all side effects reported with Keppra, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati f’ Keppra, ara l- Fuljett ta ’ Tagħrif.
Keppra should not be used in people who may be hypersensitive (allergic) to levetiracetam or other pyrrolidone derivatives (medicines with a similar structure), or to any of the other ingredients.
Keppra m’ għandiex tintuża minn persuni li jistgħu jkunu sensittivi iżżejjed (allerġiċi) għal levetiracetam jew derivattivi ta ’ pyrrolidone (mediċini bi struttura simili), jew għal sustanzi oħra tagħha.
Why has Keppra been approved?
Meta ġiet approvata Keppra?
The Committee for Medicinal products for Human Use (CHMP) decided that Keppra’ s benefits are greater than its risks as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy, as well as adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures in patients with
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Keppra huma akbar mir- riskji tagħha bħala monoterapija fit- trattament ta ’ attakki qawwija ta ’ puplesija b’ ġeneralizzazzjonijiet sekondarji jew mingħajrhom f’ pazjenti ta ’ 16- il sena li għadhom kif ġew iddijanjostikati b’ epilessija, kif ukoll bħala terapija addizzjonali fit- trattament ta ’ attakki qawwija ta ’ puplesija parzjali, myoclonic seizures f’ pazjenti b’ myoclonic epilepsy tat- tfal, u tonic- clonic
juvenile myoclonic epilepsy, and primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy.
seizures primarji u ġeneralizzati f’ pazjenti b’ epilessija idjopatika ġeneralizzata.
The Committee recommended that Keppra be given marketing authorisation.
Il- Kumitat irrakkomanda li Keppra tingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Keppra:
Tagħrif ieħor dwar Keppra:
The European Commission granted a marketing authorisation valid throughout the European Union for Keppra on 29 September 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Keppra fid- 29 ta ’ Settembru 2000.