FrancophonIA/ELRC3.0 huggingface dataset:
English: The CMDh, having considered the PRAC recommendation dated 16 May 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the revocation of the marketing authorisations of almitrine containing products for oral use.
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata s-16 ta' Mejju 2013 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq ftehim dwar ir-revoka tal-awtorizzazzjonijiet għattqegħid fis-suq għal prodotti għall-użu orali li fihom l-l-almitrina.
English: The PRAC considered that many of the publications reported that a clinical benefit of oral almitrine could not be seen in terms of exacerbations or hospitalisation, exercise capacity, clinical outcome, survival, or quality of life.
Maltese: Il-PRAC qes li ħafna mill-pubblikazzjonijiet irrapportaw li l-benefiċċju kliniku tal-almitrina orali ma setax jitqies f'termini ta' aggravamenti jew dħul l-isptar, kapaċità ta' eżerċizzju, riżultat kliniku, sopravivenza, jew kwalità tal-ħajja.
English: The PRAC is of the opinion that almitrine cannot be considered as an alternative to LTOT for which reduction in mortality has been achieved.
Maltese: Il-PRAC huwa tal-opinjoni li l-almitrina ma tistax titqies bħala alternattiva għal LTOT li għaliha inkisbet tnaqqis fil-mortalità.
English: However, no data supports the restrictive indication proposed by the MAH.
Maltese: Madankollu, l-ebda dejta ma tappoġġa l-indikazzjoni ristretta proposta mill-MAH.
English: Ansquer J.C., Bertrand A., Blaive B., Charpin J., Chretien J., Decroix G., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle B., Pariente R., Perrin-Fayolle M., Rochemaure J., Sadoul P., Voisin C. The therapeutic value and acceptability of Vectarion 50 mg coated tablets (Almitrine bismesylate) at the dose of 100 mg per day.
Maltese: 1 Ansquer J.C., Bertrand A., Blaive B., Charpin J., Chretien J., Decroix G., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle
English: In addition to peripheral neuropathies with abnormal sensations in the lower limb or paraesthesia and weight loss up to -6%, in the publications reporting clinical studies with continuous administration, the following adverse events were also more frequent in the almitrine groups:
Maltese: Minbarra newropatiji periferali b'sensazzjoni abnormali fir-riġlejn jew parasteżija u telf ta' piż sa -6%, filpubblikazzjonijiet li rrapportaw studji kliniċi b'għoti kontinwu, l-episodji avversi li ġejjin kienu wkoll aktar frekwenti fil-gruppi tal-almitrina:
English: Almitrine bismesylate is indicated in patients with respiratory failure with hypoxemia related to obstructive bronchitis.
Maltese: Two years treatment with Almitrine bismesylate in patients with hypoxic chronic obstructive airways disease.
English: This was supported by the fact that cases of peripheral neuropathy continued to be reported from September 2003 to November 2012 despite the implemented minimisation measures (recommendation for a sequential scheme of administration and dose adjustment initially, followed by contra-indications and warnings).
Maltese: Dan kien appoġġjat mill-fatt li minn Settembru 2003 sa Novembru 2012, minkejja l-miżuri fis-seħħ favur ilminimizzazzjoni implimentati (rakkomandazzjoni għal skema sekwenzjali ta' għoti u l-aġġustament inizjali tad-doża, segwit minn kontraindikazzjonijiet u twissijiet), il-każi ta' newropatija periferali komplew jiġu rrappurtati.
English: • The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Maltese: • Il-PRAC qies li l-użu tal-l-almitrina orali huwa assoċjat ma' reazzjonijiet avversi serji ta' newropatija periferali u telf ta' piż xi kultant b'konsegwenzi negattivi.
English: The PRAC, as a consequence, concluded that pursuant to Article 116 of Directive 2001/83/EC the risk-benefit balance for almitrine containing products for oral administration is not favourable.
Maltese: Għaldaqstant il-PRAC ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE l-bilanċ tar-riskjubenefiċċju għal prodotti għall-għoti orali li fihom l-l-almitrina mhuwiex favorevoli.
English: • Central nervous events (sleep disorders such as insomnia, drowsiness, agitation, anxiety, palpitations, dizziness) Based on the available publications of clinical studies with sequential treatment scheme891011 (i.e. two months of treatment followed by one month treatment interruption), the rate of withdrawal remained predominant in the almitrine groups as compared to placebo groups in the majority of the publications.
Maltese: Abbażi tal-pubblikazzjonijiet disponibbli ta' studji kliniċi bi skema ta' kura sekwenzjali891011 (jiġifieri xahrejn kura segwiti minn xahar ta' interruzzjoni tal-kura), ir-rata ta' rtirar baqgħet predominanti fil-gru tal-almitrina apparagun mal-gruppi tal-plaċebo fil-maġġoranza tal-pubblikazzjonijie ppi t.
English: Eur J
Maltese: J.A.
English: • The PRAC considered the totality of the data available for almitrine containing products for oral administration in relation to the risk of peripheral neuropathy and weight loss.
Maltese: • Il-PRAC qie li t-totalità tad-dejta disponibbli għal prodotti li fihom l-l-almitrina għall-għoti orali firrigward tar-riskju ta' newropatija periferali u telf ta' piż.
English: One of the proposed further risk minimisation measures by the MAH was a restricted indication in patients with PaO2 between 55 mmHg and 65 mmHg or as adjuvant treatment to Long Term Oxygen Therapy (LTOT).
Maltese: Waħda mill-miżuri ulterjuri għall-minimizzazzjoni tar-riskji proposta mill-MAH kienet indikazzjoni ristretta f'pazjenti b'PaO2 bejn 55 mmHg u 65 mmHg jew bħala kura miżjuda ma' Terapija fit-Tul bl-Ossiġnu (LTOT).
English: PRAC noted that in the clinical trials with results in favour of almitrine, effect of almitrine could have been overestimated as a high rate of patients withdrew predominantly in the almitrine group as compared to placebo (Voisin and al, 1987 and in most of all the clinical trials).
Maltese: Il-PRAC innota li fil-provi kliniċi b'riżultati favur l-almitrina, l-effett tal-almitrina seta' kien sopravvalutat peress li kien hemm rata għolja ta' pazjenti li rtiraw b'mod predominanti fil-grupp tal-almitrina apparagun ma' plaċebo (Voisin u al, 1987 u f'ħafna mill-provi kliniċi).
English: During the assessment, the MAH confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical benefit of oral almitrine in in the management of chronic hypoxemia in COPD.
Maltese: Matul il-valutazzjoni, il-MAH ikkonferma li d-dejta kollha disponibbli kienet ġiet ipprovduta u li mhumiex se jkunu kapaċi jipprovdu dejta ulterjuri biex juru l-benefiċċju kliniku tal-almitrina orali fil-ġestjoni talipossjemija kronika f'COPD.
English: Based on the published literature and post marketing data, the PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
Maltese: Abbażi tad-dokumentazzjoni ppubblikata u d-dejta ta' wara t-tqegħid fis-suq, il-PRAC huwa tal-opinjoni li l-miżuri għall-minimizzazzjoni tar-riskji proposti mill-MAH mhumiex se jkunu kapaċi jnaqqsu r-riskji b'mod xieraq ta' reazzjonijiet avversi severi għal livell klinikament aċċettabbli: kwalunkwe komunikazzjoni addizzjonali dwar ir-riskji ta' newropatiji u telf ta' piż, diġà magħrufa sew minn min jippreskrivi, mhijiex se tikkontribwixxi għall-użu aktar sigur tal-prodott.
English: Even if occurrence of peripheral neuropathy in COPD patients with associated conditions could be considered as a confounding factor, the occurrence of cases with positive rechallenge with almitrine during the post-marketing experience is strongly in favour of a causal relationship between almitrine and peripheral neuropathies.
Maltese: Anke jekk l-okkorrenza ta' newropatija periferali f'pazjenti b'COPD b'kundizzjonijiet assoċjati tista' titqies bħala fattur li jfixkel, waqt l-esperjenza ta' wara t-tqegħid fis-suq lokkorrenza ta' każi fejn is-sintomi reġgħu tfaċċaw meta l-almitrina reġgħet ingħatat hija ferm favur relazzjoni kawżali bejn l-almitrina u newropatiji periferali.
English: The PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
Maltese: Il-PRAC huwa tal-opinjoni li l-miżuri għall-minimizzazzjoni tar-riskji proposti mill-MAH mhumiex se jkunu kapaċi jnaqqsu b'mod adegwat ir-riskji ta' reazzjonijiet avversi severi għal livell klinikament aċċettabbli: kwalunkwe komunikazzjoni addizzjonali dwar ir-riskji ta' newropatiji u telf ta' piż, diġà magħrufa sew minn min jippreskrivi, mhijiex sejra tikkontribwixxi favur użu aktar sigur talprodott.
English: It is available as tablets (200 mg; 400 mg).
Maltese: Jiġi f'pilloli (200 mg; 400 mg).
English: The full EPAR for Votrient can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Votrient:
Maltese: Informazzjoni oħra dwar Votrient:
English: The most common side effects with Votrient (seen in more than 1 patient in 10) include reduced appetite, dysgeusia (taste disturbances), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, pain, hair colour change, fatigue (tiredness), skin hypopigmentation (discolouration of the skin), exfoliative (flaky) rash, headache, stomatitis (inflammation of the lining of the mouth), decreased weight and increased blood levels of certain liver enzymes.
Maltese: L-effetti sekondarji l-aktar komuni b'Votrient (li dehru f'aktar minn pazjent 1 minn kull 10) huma tnaqqis fl-aptit, diżgewżija (disturbi fit-togħma), ipertensjoni (pressjoni għolja tad-demm), dijarea, nawżja (tħossok ma tiflaħx), remettar, uġigħ, tibdil fil-kulur tax-xagħar, għeja (ħedla), ipopigmentazzjoni fil-ġilda (bjuda tal-ġilda), raxx esfoljattiv (tqaxxir), uġigħ ta' ras, stomatite (infjammazzjoni tar-rita tal-ħalq), tnaqqis fil-piż u żieda fil-livelli tad-demm ta' ċerti enzimi tal-fwied.
English: The active substance in Votrient, pazopanib, is a protein kinase inhibitor.
Maltese: Is-sustanza attiva f'Votrient, il-pażopanib, hija inibitur tal-proteina kinażi.
English: This document is a summary of the European Public Assessment Report (EPAR) for Votrient.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Votrient.
English: EPAR summary for the public pazopanib
Maltese: Sommarju tal-EPAR għall-pubbliku
English: Votrient is a medicine that contains the active substance pazopanib.
Maltese: Votrient huwa mediċina li fiha s-sustanza attiva pażopanib.
English: Why has Votrient been approved?
Maltese: Għaliex ġie approvat Votrient?
English: What is the risk associated with Votrient?
Maltese: X'inhu r-riskju assoċjat ma' Votrient?
English: In patients with moderate liver problems the dose should be reduced to 200 mg once a day.
Maltese: F'pazjenti bi problemi moderati fil-fwied id-doża għandha titnaqqas għal 200 mg darba kuljum.
English: What is Votrient?
Maltese: X'inhu Votrient?
English: The CHMP considered that Votrient has been shown to be an effective medicine for patients with advanced renal cell carcinoma and soft-tissue sarcoma, with a clinically relevant improvement in progression-free survival.
Maltese: Is-CHMP ikkunsidra li Votrient wera li kien mediċina effettiva għal pazjenti li jbatu minn karċinoma f'ċelloli renali fi stadju avvanzat u sarkoma tat-tessuti rotob, b'titjib klinikament rilevanti f'sopravivenza ħielsa mill-progressjoni tal-marda.
English: These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR', ‘PDGFR' and ‘KIT'.
Maltese: Dawn l-enzimi jinsabu f'xi riċetturi fuq il-wiċċ ta' ċelloli li huma involuti fit-tkabbir u t-tifrix ta' ċelloli tal-kanċer, bħal ‘VEGFR', ‘PDGFR' u ‘KIT'.
English: Votrient has been compared with placebo (a dummy treatment) in one main study involving 435 patients with advanced renal cell carcinoma, some of whom had previously been treated with cytokines.
Maltese: Votrient tqabbel ma' plaċebo (trattament finta) fi studju wieħed ewlieni li kien jinvolvi 435 pazjent li jbatu minn karċinoma f'ċelloli renali fi stadju avvanzat, li xi wħud minnhom kienu diġà ġew ikkurati b'ċitokini.
English: • advanced renal cell carcinoma, a type of kidney cancer.
Maltese: • karċinoma f'ċelloli renali fi stadju avvanzat, tip ta' kanċer tal-kliewi.
English: This was switched to a full marketing authorisation on 1 July 2013.
Maltese: Din l-awtorizzazzjoni għat-tqegħid fis-suq saret sħiħa fl-1 ta' Lulju 2013.
English: Votrient has also been compared with placebo in a main study involving 369 patients with soft-tissue sarcoma whose disease had progressed during or following previous chemotherapy.
Maltese: Votrient tqabbel ukoll ma' plaċebo fi studju ewlieni li kien jinvolvi 369 pazjent b'sarkoma tattessuti rotob li l-marda tagħhom infirxet matul jew wara kimoterapija preċedenti.
English: On average, the patients who took Votrient lived for 9.2 months without their disease getting worse, compared with 4.2 months for the patients who took placebo.
Maltese: Bħala medja, il-pazjenti kkurati b'Votrient għexu għal 9.2 xhur mingħajr ma taggravalhom il-marda tagħhom, meta mqabbla ma' 4.2 xhur għall-pazjenti kkurati bil-plaċebo.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Votrient on 14 June 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni kkondizzjonata għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Votrient fl-14 ta' Ġunju 2010.
English: The safety profile of Votrient is considered acceptable and generally manageable.
Maltese: Il-profil ta' sigurtà ta' Votrient huwa kkunsidrat aċċettabbli u ġeneralment ġestibbli.
English: Votrient is not recommended in patients with severe liver problems.
Maltese: Votrient mhuwiex rakkomandat lil pazjenti bi problemi gravi fil-fwied.
English: How has Votrient been studied?
Maltese: Kif ġie studjat Votrient?
English: The recommended dose is 800 mg once a day, but this may need to be reduced if the patient has side effects.
Maltese: Id-doża rakkomandata hija 800 mg darba kuljum, iżda jista' jkun meħtieġ li din titnaqqas jekk il pazjent ikollu effetti sekondarji.
English: Votrient was also more effective than placebo at treating soft-tissue sarcoma.
Maltese: Votrient kien ukoll iktar effettiv mill-plaċebo fil-kura tas-sarkoma tat-tessuti rotob.
English: It is used in patients who have been previously treated with chemotherapy (medicines to treat cancer) because their cancer had spread, or in patients whose cancer has progressed within 12 months after receiving adjuvant or neoadjuvant therapy (treatment received after or before their main treatment).
Maltese: Jintuża fuq pazjenti li diġà kienu ġew ikkurati b'kimoterapija (mediċini għall-kura talkanċer) peress li l-kanċer kien infirex, jew f'pazjenti li l-kanċer tagħhom infirex fi żmien 12-il xahar wara li kienu rċevew terapija b'adjuvant jew neoadjuvant (kura li rċevew wara jew qabel il-kura prinċipali tagħhom).
English: Votrient was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Maltese: Il-kura b'Votrient għandha tinbeda biss minn tabib b'esperjenza fl-għoti ta' mediċini kontra l-kanċer.
English: For the full list of all side effects reported with Votrient, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Votrient, ara l-fuljett ta' tagħrif.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Maltese: Jiġi bħala pilloli (250 mg, 500 mg, 750 mg u 1,000 mg).
English: The full EPAR for Levetiracetam Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Levetiracetam Accord?
Maltese: X'inhu Levetiracetam Accord?
English: Levetiracetam Accord is a ‘generic medicine'.
Maltese: Levetiracetam Accord huwa ‘mediċina ġenerika'.
English: The active substance in Levetiracetam Accord, levetiracetam, is an epilepsy medicine.
Maltese: Is-sustanza attiva f'Levetiracetam Accord, il-levetiracetam, hija mediċina kontra l-epilessija.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
Maltese: • aċċessjonijiet mijokloniċi (qosra, movimenti spasmodiċi donnhom xokkijiet ta' muskolu jew ta' grupp ta' muskoli) f'pazjenti minn 12-il sena 'l fuq li jbatu bl-epilessija mijoklonika ġuvenili;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Accord on3 October 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Levetiracetam Accord valida flUnjoni Ewropea kollha fit-3 ta' Ottubru 2011.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Accord.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Levetiracetam Accord.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Accord has been shown to have comparable quality and to be bioequivalent to Keppra.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, Levetiracetam Accord wera li għandu kwalità komparabbli u li huwa bijoekwivalenti ma' Keppra.
English: • 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 be inherited).
Maltese: • aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji (attakki severi, inkluż it-telf ta' koxjenza) f'pazjenti minn 12-il sena 'l fuq li jbatu bl-epilessija ġeneralizzata idjopatika (it-tip ta' epilessija li huwa maħsub li tintiret).
English: This is a type of epilepsy where excessive 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.
Maltese: Din hija tip ta' epilessija fejn attività elettrika eċċessiva f'naħa waħda tal-moħħ tikkawża sintomi bħal movimenti spasmodiċi għal għarrieda ta' xi parti millġisem, smigħ, xamm, jew viżta mhux ċari, tnemnim, jew sens ta' biża' f'daqqa.
English: Levetiracetam Accord levetiracetam
Maltese: Informazzjoni oħra dwar Levetiracetam Accord
English: The exact way in which levetiracetam works is unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod preċiż kif jaħdem illevetiracetam għadu mhux ċar iżda jidher li dan jeħel ma' proteina msejħa proteina sinaptika vexxili 2A, li hija involuta fir-rilaxx ta' messaġġiera kimiċi miċ-ċelloli tan-nervituri.
English: When Levetiracetam Accord is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Maltese: Meta Levetiracetam Accord jiżdied ma' kura oħra tal-epilessija, id-doża tal-bidu f'pazjenti minn 12-il sena 'l fuq li jiżnu aktar minn 50 kg hija ta' 500 mg darbtejn kuljum.
English: Because Levetiracetam Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Maltese: Minħabba li Levetiracetam Accord huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet sabiex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Keppra.
English: When Levetiracetam Accord is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Maltese: Meta Levetiracetam Accord jintuża waħdu, id-doża tal-bidu hija ta' 250 mg darbtejn kuljum, u tiżdied ġimagħtejn wara għal 500 mg darbtejn kuljum.
English: This means that Levetiracetam Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Maltese: Dan ifisser li Levetiracetam Accord huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Keppra.
English: Levetiracetam Accord is a medicine that contains the active substance levetiracetam.
Maltese: Levetiracetam Accord huwa mediċina li fiha s-sustanza attiva levetiracetam.
English: Why has Levetiracetam Accord been approved?
Maltese: Għaliex ġie approvat Levetiracetam Accord?
English: Because Levetiracetam Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Levetiracetam Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What are the benefits and risks of Levetiracetam Accord?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Levetiracetam Accord?
English: Epilepsy is caused by excessive electrical activity in the brain.
Maltese: Lepilessija hija kkawżata minn attività elettrika eċċessiva fil-moħħ.
English: The Committee recommended that Levetiracetam Accord be given marketing authorisation.
Maltese: Il-Kumitat irrakkomanda li Levetiracetam Accord jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Levetiracetam Accord 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.
Maltese: Levetiracetam Accord jista' jintuża waħdu f'pazjenti minn 16-il sena 'l fuq li ġew dijanjostikati għallewwel darba bl-epilessija, sabiex jikkura l-bidu parzjali ta' aċċessjoni (attakki ta' epilessija) b'ġeneralizzazzjoni sekondarja jew mingħajrha.
English: This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.
Maltese: Dan jgħin biex Levetiracetam Accord jistabbilizza l-attività elettrika fil-moħħ u jipprevjeni l-aċċessjonijiet.
English: For patients weighing less than 50 kg, the dose depends on body weight.
Maltese: F'pazjenti li jiżnu inqas minn 50 kg, id-doża tiddependi mill-piż tal-ġisem.
English: How is Levetiracetam Accord used?
Maltese: Kif jaħdem Levetiracetam Accord?
English: MA (EU) Number (Invented) name
Maltese: Numru tal-MA Numru ta' l-EU
English: Placebo n=100
Maltese: Plaċebo n=100
English: 10 to 29
Maltese: 10 sa 29
English: E-mail: safety@biocryst.com
Maltese: Indirizz tal-email: safety@biocryst.com
English: In-vitro activity
Maltese: Attività in-vitro
English: 30 to 49
Maltese: 30 sa 49
English: • The active substance is peramivir.
Maltese: • Is-sustanza attiva hi peramivir.
English: gamma-glutamyltransferase, creatine phosphokinase, urea, creatinine
Maltese: gamma-glutamyltransferase, fosfokinażi tal-kreatinina, urea, kreatinina
English: Manufacturer Seqirus Vaccines Limited Gaskill Road, Speke Liverpool
Maltese: Seqirus Vaccines Limited Gaskill Road, Speke Liverpool
English: CI = Confidence Interval
Maltese: CI = Intervall ta' Kunfidenza
English: AUClast (ng•h/mL)
Maltese: AUCaħħar (ng•h/mL)
English: • skin inflammation, eczema, rash, nettle-rash
Maltese: • infjammazzjoni fil-ġilda, ekżema, raxx, nettle-rash
English: Adults and adolescents (13 years and older)
Maltese: Adulti u adolexxenti (minn 13-il sena 'l fuq)