FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, based on an integrated population PK analysis of pooled data from the 3 paediatric studies (2 paediatric solid tumour studies and 1 paediatric GIST study; ages: 6 years to 11 years and 12 years to 17 years), baseline body surface area (BSA) was a significant covariate on apparent clearance of sunitinib and its active metabolite.
Maltese: 6 snin sa 11il sena u 12-il sena sa 17-il sena), l-erja tas-superfiċje tal-ġisem (BSA, body surface area) tal-linja bażi kienet kovarjanti sinifikanti fuq it-tneħħija apparenti ta' sunitinib u l-metabolit attiv tiegħu.
English: Treatment-naïve metastatic renal cell carcinoma
Maltese: Karċinoma metastatika refrattarja għaċ-ċitokini
English: Table 4 - pNET efficacy results from the Phase 3 study Efficacy parameter
Maltese: Tabella 4 - Riżultati tal-effikaċja fir-rigward tal-pNET mill-Istudju ta' Fażi 3 Parametru ta' effikaċja
English: Blood TSH increase was reported in 1 (0.9%) patient on sunitinib and no patients on standard of care.
Maltese: Żieda fit-TSH fid-demm ġiet irrappurtata f'pazjent 1 (0.9%) fuq sunitinib u fl-ebda pazjent b'terapija standard.
English: In the second part of the study, including patients with prior anticancer therapy but without risk factors for cardiac toxicity, sunitinib was generally tolerable and clinically manageable at the dose of 15 mg/m daily (MTD) on Schedule 4/2.
Maltese: Fit-tieni parti tal-istudju li tinkludi pazjenti b'terapija kontra l-kanċer minn qabel iżda mingħajr fatturi ta' riskju għat-tossiċità kardijaka, sunitinib kien ġeneralment tollerabbli u klinikament maniġibbli bid-doża ta' 15mg/m2 kuljum (MTD) fuq Skeda
English: • Nasal dryness, congested nose.
Maltese: • Nixfa nażali, konġestjoni nażali.
English: Ejection fraction decreased/abnormal.
Maltese: Proporzjon ta' periklu = 0.
English: QT interval prolongation
Maltese: Waqt l-analiżi Finali
English: Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules.
Maltese: Kapsuli tal-ġelatina b'għatu kulur il-karamella u bil-parti ewlenija kulur il-karamella, bil-kelma “Pfizer” stampata b'inka bajda fuq l-għatu, “STN 50 mg” fuq il-parti ewlenija, u li fihom granijiet safrani għal oranġjo.
English: Periorbital oedema Eyelid oedema Lacrimation increased
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: A confirmatory, open-label, single-arm, multi-centre study evaluating the efficacy and safety of sunitinib was conducted in patients with MRCC who were refractory to prior cytokine therapy.
Maltese: Studju konfermatorju, open-label, ta' driegħ wieħed, f'ċentri multipli li evalwa l-effikaċja u s-sigurtà ta' sunitinib kien magħmul f'pazjenti b'MRCC li kienu refrattarji għat-terapija minn qabel b'ċitokini.
English: You should inform your doctor if you are taking medicines containing the following active substances: ▪ ketoconazole, itraconazole - used to treat fungal infections ▪ erythromycin, clarithromycin, rifampicin -used to treat infections ▪ ritonavir -used to treat HIV ▪ dexamethasone - a corticosteroid used for various conditions (such as allergic/breathing disorders or skin diseases) ▪ phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological conditions ▪ herbal preparations containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety
Maltese: Dawn ilkumplikazzjonijiet huma kkawżati mit-tkissir tal-prodotti ta' ċelluli tal-kanċer li jkunu qed imutu u jistgħu jinkludu dawn li ġejjin: nawseja, qtugħ ta' nifs, taħbit tal-qalb irregolari, bugħawwieġ fil-muskoli, puplesija, tidnis tal-awrina u għeja assoċjata ma' riżultati mhux normali tat-testijiet tal-laboratorju (livelli għoljin tal-potassju, aċidu uriku u fosfru u livelli baxxi ta' kalċju fid-demm) li jistgħu jwasslu għal bidliet fil-funzjoni tal-kliewi u insuffiċjenza renali akuta.
English: (aneurysms and artery dissections).
Maltese: theddida għall-ħajja).
English: T3 increase was reported in 1 (0.8%) patient on sunitinib and no patients on capecitabine.
Maltese: Żieda fit-T3 ġiet irrappurtata f'pazjent 1 (0.8%) b'sunitinib u fl-ebda pazjent b'capecitabine.
English: • Abnormal blood tests including pancreatic and liver enzymes.
Maltese: • Testijiet tad-demm b'riżultat mhux normali li jinkludu enzimi tal-frixa u tal-fwied.
English: Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Maltese: Raxx sever fil-ġilda (sindromu ta' Stevens-Johnson, nekroliżi epidermali tossika, eritema multiformi) kien irrapurtat waqt l-użu ta' sunitinib, li deher fil-bidu bħala tikek bi dbabar ħomor jew irqajja' ċirkolari spiss b'infafet fin-nofs fuq it-tronk.
English: Blood and lymphatic system disorders
Maltese: Disturbi fissistema endokrinarja
English: HDPE BOTTLE OUTER CARTON - 12.5 MG CAPSULES
Maltese: PAKKETT TA' BARRA FLIXKUN HDPE - 12.5
English: Limited information is available on the continued use of sunitinib in patients with fistulae (see section 4.8).
Maltese: Hemm tagħrif limitat dwar ittkomplija ta' l-użu ta' sunitinib f'pazjenti b'fistuli oħra (ara sezzjoni 4.8).
English: - Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
Maltese: - Karċinoma metastatika taċ-ċellola renali (MRCC), tip ta' kanċer tal-kliewi li jkun infirex f'partijiet oħra tal-ġisem.
English: Furthermore, according to the published literatures in paediatric patients with GIST, the calculated starting dose ranged from 16.6 mg/m to 36 mg/m increased to doses as high as 40.4 mg/m
Maltese: Barra minn hekk, skont il-letteraturi ppubblikati fil-pazjenti pedjatriċi b'GIST, id-doża tal-bidu kkalkulata varjat minn 16.6 mg/m 2 sa 36 mg/m 2, żdiedet għal dożi għoljin daqs 40.4 mg/m 2 (biex ma taqbiżx id doża totali ta' 50 mg/jum).
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jaffettwa sa persuna 1 minn kull 100
English: Transient ischaemic attack
Maltese: Waqt l-analiżi
English: Results from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) showed that the overall global health-related quality of life and the 5 functioning domains (physical, role, cognitive, emotional, and social) were maintained for patients on sunitinib treatment as compared to placebo with limited adverse symptomatic effects.
Maltese: Ir-riżultati mill-Kwestjonarju dwar il-Kwalità tal-Ħajja tal-Organizzazzjoni Ewropea għar-Riċerka u tTrattament tal-Kanċer (EORTC QLQ-C30) wrew li l-kwalità ġenerali tal-ħajja relatata mas-saħħa globali u l-5 oqsma ta' funzjonament (fiżiku, rwol, konoxxittiv, emozzjonali u soċjali) kienu miżmuma għall-pazjenti li rċevew trattament b'sunitinib meta mqabbel ma' plaċebo, b'effetti sintomatiċi avversi limitati.
English: Severe hypertension was reported in 12% of treatment-naïve patients on sunitinib and < 1% of patients on IFN-.
Maltese: Pressjoni għolja ħafna żviluppat fi 12% tal-pazjenti fuq sunitinib li qatt ma kienu ttrattati qabel u < 1% tal-pazjenti fuq IFN-.
English: Although an effect on QTcF interval was observed on Day 3 at 24 hours postdose (i.e., at therapeutic plasma concentration expected after the recommended starting dose of 50 mg) with the within-day baseline correction method, the clinical significance of this finding is unclear.
Maltese: Għalkemm ġie osservat effett fuq l-intervall QTcF f'Jum 3, 24 siegħa wara d-doża (jiġifieri filkonċentrazzjoni terapewtika fil-plasma mistennija wara d-doża inizjali rakkomandata ta' 50 mg) bilmetodu ta' korrezzjoni tal-linja bażi fl-istess ġurnata, mhux ċar is-sinifikat kliniku ta' din is-sejba.
English: Haemoptysis Dyspnoea exertional Oropharyngeal painn
Maltese: Emorraġija gastrointestinali Esofaġite Distensjoni addominali
English: Post-marketing adverse reactions identified in clinical studies are also included.
Maltese: Reazzjonijiet avversi wara t-tqegħid fis-suq identifikati fi studji kliniċi huma inklużi ukoll.
English: Pericardial effusion Electrocardiogram QT prolonged
Maltese: Kif jidher Sutent u l-kontenut tal-pakkett
English: Hepatotoxicity
Maltese: Edema periorbitali
English: Additionally, 49% of sunitinib patients had nonfunctioning tumours versus 52% of placebo patients and 92% of patients in both arms had liver metastases.
Maltese: Barra minn hekk, 49% tal-pazjenti li ħadu sunitinib kellhom tumuri li ma jiffunzjonawx kontra 52% tal-pazjenti fuq plaċebo u 92% tal-pazjenti fiż-żewġ gruppi kellhom metastasi tal-fwied.
English: The primary analysis of PFS showed a statistically significant difference in favour of bevacizumab (HR 0.64, 95%CI 0.55-0.74; p<0.0001).
Maltese: L-analiżi primarja tal-PFS uriet differenza statistikament sinifikanti favur bevacizumab (HR 0.64, 95%CI 0.55-0.74; p<0.0001).
English: The CHMP considers that:
Maltese: Is-CHMP iqis li:
English: Disease progression was assessed using adapted Macdonald criteria (Chinot et al., 2013).
Maltese: Il-progressjoni tal-mard ġiet evalwata bl-użu talkriterji Macdonald adattati (Chinot et al., 2013).
English: According to this analysis, 84% of the PFS events could be considered unequivocal.
Maltese: Skont din l-analiżi, 84% tal-avvenimenti ta' PFS jistgħu jitqiesu bħala inekwivoki.
English: Arterial thromboembolic events, mainly ischaemic strokes, were observed at a slightly higher incidence rate in this trial (5.0%) than in previous bevacizumab trials (up to 3.8% in combination with different chemotherapies), and higher than in the placebo group (1.6%).
Maltese: Avvenimenti arterjali tromboemboliċi, l-iktar puplesiji iskemiċi, ġew osservati f'inċidenza ftit ogħla f'din il-prova (5.0%) milli fi provi preċedenti bi bevacizumab (sa 3.8% flimkien ma' kemoterapiji differenti), u ogħla milli fil-grupp tal-plaċebo (1.6%).
English: Key post-hoc sensitivity analyses that took into account the concerns raised by the CHMP on the reliability of the imaging technique to detect disease progression excluded patients 1) with potential or confirmed pseudo-progression, 2) with possible pseudo-progression in the Pl+RT/T arm and possible pseudo-response in the Bv+RT/T arm and 3) with PFS < Day 93 to avoid any potential impact of pseudo-progression and post-radiation imaging changes at the first disease assessment.
Maltese: Analiżijiet ewlenin ta' sensittività post-hoc, li qiesu t-tħassib imqajjem mis-CHMP fuq l-affidabilità tatteknika tal-immaġini, biex jiskopru l-progressjoni tal-mard eskludiet pazjenti 1) bi psewdprogressjoni potenzjali jew ikkonfermata, 2) bi psewdo-progressjoni possibbli fil-fergħa Pl+RT/T u psewdo-rispons fil-fergħa Bv+RT/T u 3) b'PFS < Jum 93 biex jiġi evitat impatt potenzjali fuq il-psewdo-progressjoni u tibdil fl-immaġini ta' wara r-radjazzjoni fl-ewwel valutazzjoni tal-mard.
English: Finally, the applicant provided a post-hoc analysis in line with the RANO criteria (Wen et al., 2010), which are the current standard used in clinical trials.
Maltese: Fl-aħħar nett, l-applikant ipprovda analiżi post-hoc f'konformità mal-kriterji RANO (Wen et al., 2010), li huwa l-istandard attwali użat fil-provi kliniċi.
English: The analysis OS showed no statistically significant difference in survival time between the bevacizumab arm and the placebo arm (HR 0.89, 95% CI 0.75-1.07, p=0.2135).
Maltese: L-OS tal-analiżi ma uriet ebda differenza statistikament sinifikanti fiż-żmien ta' sopravivenza bejn il-fergħa ta' bevacizumab u l-fergħa tal-plaċebo (HR 0.89, 95% CI 0.75-1.07, p=0.2135).
English: Several strategies were applied prospectively in Avaglio in order to minimize the possibility of incorrectly interpreting the MRI scan including implementation of an algorithm for the determination of pseudo-progression.
Maltese: Ġew applikati diversi strateġiji prospettivament f'Avaglio sabiex titnaqqas il-possibilità ta' interpretazzjoni żbaljata tal-iskenn MRI, inkluż implimentazzjoni ta' algorittmu għad-determinazzjoni ta' psewdoprogressjoni.
English: The demonstration of efficacy was based on a randomized, double-blind, placebo controlled, multicenter phase III trial (study BO21990, “AVAglio”) of bevacizumab, temozolomide and radiotherapy (concomitant phase) followed by bevacizumab and temozolomide (maintenance phase) followed by bevacizumab (monotherapy phase) versus placebo, temozolomide (TMZ) and radiotherapy followed by placebo and temozolomide followed by placebo in patients with newly diagnosed glioblastoma (GBM).
Maltese: III, randomizzata, double-blind, ikkontrollata bi plaċebo, b'aktar minn ċentru wieħed (studju BO21990, “AVAglio”) ta' bevacizumab, temozolomide u radjoterapija (fażi konkomittanti) segwit minn bevacizumab u temozolomide (fażi ta' manteniment) segwit minn bevacizumab (fażi ta' monoterapija) meta mqabbel ma' plaċebo f'pazjenti li kienu għadhom kif ġew dijanjostikati bi glijoblastoma (GBM).
English: The most frequent toxicity associated with the bevacizumab treatment group were gastrointestinal (nausea, constipation, vomiting), alopecia, fatigue, thrombocytopenia, headache and hypertension.
Maltese: L-iktar tossiċità frekwenti assoċjata mal-grupp ta' kura bi bevacizumab kienet gastrointestinali (dardir, stitikezza, rimettar), alopeċja, għeja, tromboċitopenja, uġigħ ta' ras u pressjoni għolja.
English: Reliability of PFS: The applicant considered that the robustness and reliability of the primary analysis of PFS was confirmed in a number of predefined and post-hoc sensitivity analyses.
Maltese: L-applikant ikkunsidra li r-robustezza u l-affidabilità tal-analiżi primarja talPFS ġiet ikkonfirmata f'numru ta' analiżijiet predefiniti u ta' sensittività post-hoc.
English: The median PFS was estimated to be 10.6 months in the bevacizumab arm and 6.2 months in the placebo arm.
Maltese: Il-PFS medjan kien stmat li hu 10.6 xhur fil-fergħa ta' bevacizumab u 6.2 xhur fil-fergħa tal-plaċebo.
English: These apparent responses are not always necessarily indicative of a true antiglioma effect.
Maltese: Dawn ir-risponsi evidenti mhux neċessarjament dejjem ikunu indikattivi tal-effett veru tal-antiglijoma.
English: • In the absence of established efficacy, a positive benefit-risk balance has not been established.
Maltese: • Fin-nuqqas ta' effikaċja stabbilita, ma ġiex stabbilit bilanċ pożittiv tal-benefiċċji-riskju.
English: Nominally, statistically significant results were retained for some parameters when PD was not counted as a deterioration event.
Maltese: Nominalment, riżultati statistikament sinifikanti kienu miżmuma għal xi parametri meta l-PD ma ġiex magħdud bħala avveniment ta' deterjorazzjoni.
English: Bevacizumab was administered at a dose of 10 mg/kg every two weeks in the concurrent phase and the maintenance phase, and at a dose of 15 mg/kg every three weeks in the monotherapy phase.
Maltese: Bevacizumab ingħata f'doża ta' 10 mg/kg kull ġimagħtejn fil-fażi simultanja u l-fażi ta' manteniment, u f'doża ta' 15 mg/kg kull tliet ġimgħat fil-fażi ta' monoterapija.
English: The observed efficacy results in study BO21990 were overall consistent with the results reported from another trial investigating the effect of bevacizumab in glioblastoma (RTOG0825), i.e., no effect on OS, no benefit in terms of HRQoL, and possibly even a detriment in neurocognitive functioning (as suggested in study RTOG0825).
Maltese: Ir-riżultati tal-effikaċja osservati fi studju BO21990 kienu ġeneralment konsistenti mar-riżultati rrappurtati minn prova oħra li investigat l-effett ta' bevacizumab fi glijoblastoma (RTOG0825), jiġifieri, ebda effett fuq OS, ebda benefiċċji f'termini ta' HRQoL, u possibbilment saħansitra detriment fil-funzjonament newrokonjittiv (kif issuġġerit minn studju RTOG0825).
English: Radiotherapy and TMZ were administered in line with standard regimens used in the setting of newly diagnosed glioblastoma (Stupp et al., 2005).
Maltese: Radjoterapjia u TMZ ingħataw f'konformità ma' korsijiet standard użati fl-ambjent ta' glijoblastoma kienet għadha kif ġiet dijanjostikata (Stupp et al., 2005).
English: Clinical relevance of PFS: The applicant considered that Avaglio study used a variety of validated and reliable measures to assess the clinical status that captured the patient's perspective (health-related quality of life [HRQOL]), neurocognitive function (Mini Mental Status Examination [MMSE]), and functional status (Karnofsky Performance Status [KPS]).
Maltese: L-applikant qies li l-istudju Avaglio kien uża varjetà ta' miżuri vvalidati u affidabbli biex jivvaluta l-istatus kliniku li kien jinkludi l-perspettiva tal-pazjent (ilkwalità tal-ħajja relatata mas-saħħa [HRQOL]), il-funzjoni newrokonjittiva (Mini Mental Status Examination [MMSE]), u l-istatus funzjonali (Karnofsky Performance Status [KPS]).
English: No new safety signals with bevacizumab were observed in study BO21990, but there was a higher incidence of Grade 3 and 4 AEs, SAEs, non-progression deaths, and discontinuations of treatment in the bevacizumab group.
Maltese: Ebda sinjal ġdid ta' sigurtà ma ġie osservat b'bevacizumab fi studju BO21990, iżda kien hemm inċidenza ogħla ta' AEs ta' Grad 3 u 4, SAEs, imwiet mhux ta' progressjoni, u twaqqif tal-kura fil-grupp ta' bevacizumab.
English: Therefore, the CHMP concluded on 22 May 2014 that the benefit/risk ratio of bevacizumab in combination with radiotherapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma was negative.
Maltese: Għalhekk, fit-22 ta' Mejju 2014, is-CHMP ikkonkluda li l-proporzjon benefiċċju/riskju ta' bevacizumab f'kombinazzjoni ma' radjoterapija u temozolomide għall-kura ta' pazjenti adulti li jkunu għadhom kif ġew dijanjostikati bi glijoblastoma kien wieħed negattiv.
English: Overall survival (OS) and progression-free survival (PFS) as assessed by the investigator were co-primary endpoints of the trial.
Maltese: Sopravivenza ġenerali (OS) u sopravivenza bla progressjoni (PFS) kif evalwati mill-investigatur kienu punti ta' tmiem ko-primarji tal-prova.
English: • Efficacy issues
Maltese: • Kwistjonijiet ta' effikaċja
English: This is in agreement with the conclusions of the Scientific Advisory Group (SAG) consulted.
Maltese: Dan huwa fi qbil malkonklużjonijiet tal-Grupp Konsultattiv Xjentifiku (SAG) li ġie kkonsultat.
English: Overall the conclusion on the efficacy of bevacizumab in this setting was that the clinical relevance of the observed effect on PFS cannot be determined and that a relevant effect has not been established on the basis of any other clinical relevant endpoint.
Maltese: Il-kwistjoni ewlenija tal-effikaċja kienet dwar ir-relevanza klinika tal-punt ta' tmiem radjoloġiku PFS fin-nuqqas ta' effett klinikament relevanti fuq OS.
English: Following the CHMP scientific conclusions adopted in 22 May 2014 that Avastin was not approvable in combination with radiotherapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma on the basis of the following grounds for the refusal of the Marketing Authorisation:
Maltese: Wara l-konklużjonijiet xjentifiċi tas-CHMP adottati fit-22 ta' Mejju 2014 li Avastin ma kienx approvabbli f'kombinazzjoni ma' radjoterapija u temozolomide għall-kura ta' pazjenti adulti li jkunu għadhom kemm ġew dijanjostikati bi glijoblastoma fuq il-bażi tar-raġunijiet għar-rifjut tal-Awtorizzazzjoni għat-Tqegħid fis-Suq li ġejjin:
English: The applicant did not convincingly show that the sensitivity analyses performed were able to mitigate the risk of systematic biases in the evaluation of PFS and were adequate to provide sufficient reassurance that bevacizumab produces a PFS increase of clinically important magnitude.
Maltese: L-applikant ma weriex b'mod konvinċenti li l-analiżijiet ta' sensittività mwettqa kienu kapaċi jtaffu r-riskju tal-preġudizzji sistematiċi fil-valutazzjoni tal-PFS u kienu adegwati biex jipprovdi riassigurazzjoni suffiċjenti li bevacizumab jipproduċi żieda fil-PFS ta' kobor klinikament importanti.
English: In conclusion, as the clinical relevance of the efficacy results is uncertain, and the benefit-risk balance of bevacizumab as an add-on therapy to standard of care for newly diagnosed glioblastoma is considered negative.
Maltese: Bħala konklużjoni, peress li r-relevanza klinika tar-riżultati tal-effikaċja hija waħda inċerta, ilbilanċ tal-benefiċċju-riskju ta' bevacizumab bħala terapija miżjuda ma' standard ta' kura għal glijoblastoma li tkun għadha kif ġiet dijanjostikata huwa meqjus negattiv.
English: 60 minutes later.
Maltese: 60 minuta wara.
English: B - 1000 Brussels Belgium medinfoeuceemea@shire.com
Maltese: B - 1000 Brussels Il-Belġju medinfoeuceemea@shire.com
English: NL-1066 CX Amsterdam The Netherlands
Maltese: NL-1066 CX Amsterdam L-Olanda
English: 1077 XX Amsterdam The Netherlands
Maltese: 1077 XX Amsterdam L-Olanda
English: Units
Maltese: Unità
English: Prevention:
Maltese: Prevenzjoni:
English: Date of first authorisation: 15 June 2011 Date of latest renewal: 26 May 2016
Maltese: Data tal-aħħar tiġdid: 26 Mejju 2016
English: Shire Services BVBA Rue Montoyer 47 B - 1000 Brussels Belgium
Maltese: Shire Services BVBA Rue Montoyer 47 B - 1000
English: (), 1000 Units
Maltese: , 1000 Unità
English: n= number of subjects evaluated.
Maltese: n= numru ta' persuni evalwati.
English: See section 2).
Maltese: Ara sezzjoni 2).
English: subjects (>25 kg) 1500 Units
Maltese: (>25 kg) 1500 Unità
English: Single Dose (1000 Units*)
Maltese: Doża Waħda (1000 Unità*)
English: C1 inhibitor is a member of the serine protease inhibitor, or serpin, superfamily of proteins.
Maltese: L-inibitur ta' C1 hu membru tal-inibitur ta' serine protease, jew serpin, superfamilja ta' proteini.
English: * Historically assigned potency values are expressed in in-house Units (U).
Maltese: * Storikament, valuri ta' potenza assenjati huma espressi f'Unitajiet “in-house” (U).
English: Cinryze contains sodium
Maltese: Cinryze fih sodium
English: 6 to 11 years:
Maltese: 6 sa 11-il sena:
English: 500 IU
Maltese: Agħti 500
English: Age-Group 6-11 years:
Maltese: Grupp ta' età 6-11-il sena:
English: Median interval was 0.5 hours (range: 0.25-2.5 hours): 1.25, 0.25, and 0.5 hours in the 500 Units(), 1000 Units(), and 1500 Units() Cinryze groups, respectively.
Maltese: 0.25-2.5 sigħat): 1.25, 0.25, u 0.5 sigħat fil-gruppi ta' 500
English: Currently available data are described in sections 4.8, 5.1, and 5.2.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5
English: The total protein content of the reconstituted solution is 15 ± 5 mg/ml.
Maltese: Il-kontenut totali tal-proteini tas-soluzzjoni rikostitwita hu ta' 15 ± 5 mg/ml.
English: Powder vial: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine and L-threonine.
Maltese: Kunjett bit-trab: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine u L-threonine.
English: Data from two randomised, double-blind, placebo-controlled studies (LEVP 2005-1/A and LEVP 2005-1/B), data from two open-label studies (LEVP 2006-1 and LEVP 2006-4) and 2 paediatric clinical studies (0624-203 and 0624-301) demonstrated the efficacy of Cinryze for the treatment and prevention of angioedema attacks in subjects with HAE.
Maltese: Dejta minn żewġ studji li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo (LEVP 2005-1/A u LEVP 2005-1/B), dejta minn żewġ studji open-label (LEVP 2006-1 u LEVP 2006-4) u 2 studji kliniċi pedjatriċi (0624-203 u 0624-301) urew l-effikaċja ta' Cinryze għallkura u l-prevenzjoni ta' attakki ta' anġjoedema f'persuni b'HAE.
English: Double Dose (1000 Units dose followed by a second 1000 Units dose 60 minutes later)
Maltese: Doża Doppja (Doża ta' 1000 Unità segwita mit-tieni doża ta' 1000 Unità 60 minuta aktar tard)
English: In open-label study LEVP 2006-1, 101 subjects were treated for a total of 609 acute HAE attacks (median 3 attacks per subject; range: 1-57).
Maltese: Fl-istudju open-label LEVP 2006-1, 101 persuni kienu kkurati għal total ta' 609 attakk akut ta' HAE (medjan ta' 3 attakki f'kull persuna; medda: 1-57).
English: The expected consequence of metabolism of a glycoprotein is via degradation to small peptides and individual amino acids.
Maltese: Il-konsegwenza mistennija ta' metaboliżmu ta' glikoproteina hi permezz ta' degradazzjoni għal peptides żgħar u amino aċidi individwali.