FrancophonIA/ELRC3.0 huggingface dataset:
English: On 18 October 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levothyroxine Alapis.
Maltese: Fit-18 ta' Ottubru 2012 l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' ftehim bejn Stati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Levothyroxine Alapis.
English: The active substance in Levothyroxine Alapis, levothyroxine sodium, is a synthetic form of the hormone thyroxine.
Maltese: Is-sustanza attiva f'Levothyroxine Alapis, il-levotiroksina sodika, hija għamla sintetika tal-ormon tirossina.
English: Alapis S.A. submitted an application for Levothyroxine Alapis to the Dutch medicines regulatory agency for a decentralised procedure.
Maltese: Alapis S.A. ressqet applikazzjoni għal Levothyroxine Alapis lill-aġenzija regolatorja tal-mediċini talPajjiżi l-Baxxi għal proċedura deċentralizzata.
English: • conditions in which the thyroid gland is underactive (hypothyroidism, including diffuse non-toxic goitre) and so does not make enough thyroxine for the body's needs;
Maltese: • kundizzjonijiet li fihom il-glandola tat-tirojde ma tkunx attiva biżżejjed (ipotirojdiżmu inkluż il gozzu diffuż non-tossiku) u għalhekk ma tipproduċix tirossina biżżejjed għall-ħtiġijiet tal-ġisem;
English: • a condition known as Hashimoto's thyroiditis, in which the immune system (the body's natural defences) attacks the thyroid causing it to swell and preventing it from working properly;
Maltese: • kundizzjoni magħrufa bħala tirojdite ta' Hashimoto, li fiha s-sistema immunitarja (id-difiżi naturali tal-ġisem) tattakka lit-tirojde, ġġiegħlha tintefaħ u xxekkilha milli taħdem sewwa;
English: Levothryoxine Alapis is a medicine that contains the active substance levothyroxine sodium.
Maltese: Levothryoxine Alapis hija mediċina li fiha s-sustanza attiva levotiroksina sodika.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that there was a risk that the dropper used for delivery might deliver variable doses, and that large numbers of drops might be hard to count.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli fil-mument u tad-diskussjoni xjentifika li saret millKumitat, is-CHMP qabel li kien hemm riskju li l-qattara użata għad-dożaġġ tista' tagħti dożi varjabbli, u li jkun hemm diffikultajiet fl-għadd preċiż tal-qtar.
English: Therefore the CHMP concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and that the marketing authorisation should not be granted in the concerned Member States.
Maltese: Għalhekk isCHMP ikkonkluda li l-benefiċċji ta' Levothyroxine Alapis ma jisbqux ir-riskji tiegħu, u li għaldaqstant lawtorizzazzjoni għat-tqegħid fis-suq ma għandhiex tingħata fl-Istati Membri interessati.
English: However, the Member States were not able to reach an agreement and the Dutch agency referred the matter to the CHMP for arbitration on 26 January 2012.
Maltese: Madankollu l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini tal-Pajjiżi lBaxxi, irriferiet il-kwistjoni lis-CHMP għal arbitraġġ fis-26 ta' Jannar 2012.
English: This could potentially lead to medication errors and pose a risk to public health.
Maltese: Dan jista' jikkaġuna żbalji terapewtiċi u joħloq riskji għas-saħħa pubblika.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned
Maltese: F'din il-proċedura Stat Membru wieħed (l-'Istat Membru ta' referenza', f'dan il-każ il-Pajjiżi l-Baxxi) jivvaluta mediċina bil-għan li jagħti awtorizzazzjoni għattqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-'Istati Membri interessati',
English: The grounds for the referral were concerns raised by the UK related to the dropper insert as a proposed administration device, due to the large number of drops that may be required and concerns about its accuracy in delivering the required dose.
Maltese: Peress li s-soluzzjoni hija kkonċentrata ħafna u ssustanza attiva hija qawwija ħafna, kien hemm riskju mhux aċċettabbli ta' żbalji terapewtiċi serji.
English: In addition, there remained concern over the safety of the long-term use of the ingredients ethanol and propylene glycol in children, and some groups of adults such as those with alcoholism.
Maltese: Barra dan, kien għad baqa' tħassib dwar is-sigurtà fl-użu fit-tul tas-sustanzi tas-sustanzi etanolu u glikolu propileniku fit-tfal u f'xi gruppi ta' adulti bħal dawk bi problemi ta' alkoħoliżmu.
English: Levothyroxine Alapis was intended to be used to treat:
Maltese: Levothyroxine Alapis kien tfassal biex jintuża fil-kura ta':
English: Thyroxine is normally produced in the body by the thyroid gland in the neck.
Maltese: Normalment il-produzzjoni fil-ġisem tat-tirossina ssir mill-glandola tattirojde fl-għonq.
English: 56 capsules
Maltese: 56 kapsula
English: EU (MA) Number
Maltese: Numru UE (MA)
English: 30 mg Capsule, hard Oral use bottle (HDPE)
Maltese: 30 mg Kapsula, iebsa
English: Strength Pharmaceutical Form
Maltese: Farmaċewtika
English: Pack size
Maltese: Imballaġġ
English: (Invented) name
Maltese: Isem (ivvintat) Qawwa Għamla
English: The full EPAR for Doribax 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: This summary was last updated in 07-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2012.
English: Doribax is an antibiotic.
Maltese: Doribax huwa antibijotiku.
English: The standard dose of Doribax is 500 mg every eight hours.
Maltese: Id-doża standard ta' Doribax hija 500 mg kull tmien sigħat.
English: Doribax is a medicine containing the active substance doripenem.
Maltese: Doribax huwa mediċina li fiha s-sustanza attiva doripenem.
English: This is a summary of the European public assessment report (EPAR) for Doribax.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Doribax.
English: The active substance in Doribax, doripenem, is an antibiotic that belongs to the group ‘carbapenems'.
Maltese: Is-sustanza attiva f'Dorimax, id-doripenem, huwa antibijotiku li jappartjeni għall-grupp ta' ‘karbapenems'.
English: • in complicated urinary tract infections, 82% of the patients receiving Doribax were cured (230 out of 280), compared with 83% of the patients receiving levofloxacin (221 out of 265).
Maltese: • f'infezzjonijiet tal-passaġġ awrinarju, fiequ 82% tal-pazjenti li kienu qegħdin jirċievu Doribax (230 minn 280), meta mqabbla ma' 83% tal-pazjenti li kienu qegħdin jirċievu levofloxacin (221 minn
English: • looking at the results of the two studies in nosocomial pneumonia taken together, 75% of the patients receiving Doribax were cured (195 out of 260), compared with 72% of the patients taking piperacillin/tazobactam or imipenem (174 out of 241);
Maltese: • fir-riżultati taż-żewġ studji ta' pnewmonja nażokomjali meħudin flimkien, fiequ 75% tal-pazjenti li kienu qegħdin jirċievu Doribax (195 minn 260), meta mqabbla ma' 72% tal-pazjenti li kienu qegħdin jieħdu piperacillin/tazobactam jew imipenem (174 minn 241);
English: • looking at the results of the two studies of complicated abdominal infections taken together, 85% of the patients receiving Doribax were cured (275 out of 325), compared with 84% of the patients receiving meropenem (260 out of 309);
Maltese: • fir-riżultati taż-żewġ studji ta' infezzjonijiet addominali kkumplikati meħudin flimkien, fiequ 85% tal-pazjenti li kienu qegħdin jirċievu Doribax (275 minn 325), meta mqabbla ma' 84% tal-pazjenti li kienu qegħdin jirċievu meropenem (260 minn 309);
English: • two studies compared Doribax with meropenem in a total of 962 patients with complicated
Maltese: • żewġ studji qabblu Doribax ma' meropenem f'total ta' 962 pazjent b'infezzjonijiet ikkumplikati fl addome;
English: Why has Doribax been approved?
Maltese: Għaliex ġie approvat Doribax?
English: The list of bacteria against which Doribax is active can be found in the summary of product characteristics (also part of
Maltese: Il-lista ta' batterji kontra liema huwa attiv Doribax tinstab fis-sommarju tal-karatteristiċi tal-prodott (huwa parti wkoll mill-EPAR).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Doribax on 25 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Doribax valida fl-Unjoni Ewropea kollha fil-25 ta' Lulju 2008.
English: • one study compared Doribax with levofloxacin in 753 patients with complicated urinary tract
Maltese: • studju wieħed qabbel Doribax ma' levofloxacin f'753 pazjent b'infezzjonijiet ikkumplikati tal passaġġ awrinarju.
English: What is the risk associated with Doribax?
Maltese: X'inhu r-riskju assoċjat ma' Doribax?
English: Other information about Doribax
Maltese: Doribax doripenem
English: The CHMP decided that Doribax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Doribax huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: It must not be used in patients who are severely allergic to other ‘beta-lactam' antibiotics, such as penicillins or cephalosporins.
Maltese: M'għandux jintuża f'pazjenti li huma severament allerġiċi għal antibijotiċi ‘betalactam' oħrajn, bħall- peniċillini u l-kefalosporini.
English: • complicated infections of the urinary tract (the structures that carry urine).
Maltese: • infezzjonijiet ikkumplikati tal-passaġġ awrinarju (l-istrutturi li jġorru l-awrina).
English: Doribax has been studied in five main studies that compared Doribax with other antibiotics: • two studies compared Doribax with piperacillin/tazobactam or imipenem in a total of 979 patients
Maltese: • pnewmonja nożokomjali (infezzjoni tal-pulmuni). ‘Nożokomjali' tfisser li l-infezzjoni ttieħdet fi sptar, inkluża pnewmonja ikkawżata permezz tal-użu ta' ventilatur (magna li tgħin pazjent biex jieħu n-nifs);
English: How does Doribax work?
Maltese: X'inhu Doribax?
English: When treating nosocomial pneumonia, a dose of 1 g every eight hours infused over four hours may be considered for patients who have augmented renal clearance (where the kidneys clear the medicine from the body too quickly) or whose infection is caused by certain types of bacteria.
Maltese: Fil-kura ta' pnewmonja nożokomjali, tista' tiġi kkunsidrata doża ta' 1 g kull tmien sigħat mogħtija fuq medda ta' erba' sigħat għal pazjenti li jbatu minn tisfija renali awmentata (meta l-kliewi jneħħu l-mediċina mill-ġisem malajr wisq) jew meta linfezzjoni tagħhom hija kkawżata minn ċerti tipi ta' batterji.
English: For the full list of all side effects reported with Doribax, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Doribax ara l-fuljett ta' tagħrif.
English: It is available as a powder to be made up into a solution for infusion (drip into a vein).
Maltese: Jiġi bħala trab li jitħallat f'soluzzjoni għallinfużjoni (dripp fil-vina).
English: 26 July 2013
Maltese: 26 ta' Lulju 2013
English: The full European Public Assessment Report for Effentora 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: The active substance in Effentora, fentanyl, is an opioid.
Maltese: Is-sustanza attiva f'Effentora, fentanyl, hija opjojde.
English: What is Effentora?
Maltese: X'inhu Effentora?
English: Each patient ranked their pain intensity on a scale of 0 to 10.
Maltese: Kull pazjent ikklassifika l-intensità tal-uġigħ tiegħu fuq skala minn 0 sa 10.
English: Effentora is a medicine that contains the active substance fentanyl.
Maltese: Effentora hija mediċina li fiha s-sustanza attiva fentanyl.
English: Effentora is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Maltese: Effentora huwa disponibbli bħala 'pilloli bokkali' (pilloli li jdubu fil-ħalq).
English: It has been authorised in the European Union since 4 April 2008.
Maltese: Ilu awtorizzat fl-Unjoni Ewropea mill-4 ta' April 2008.
English: On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.
Maltese: Fil-11 ta' Lulju 2013, Teva Pharma B.V. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) li hija tixtieq tirtira l-applikazzjoni tagħha għal indikazzjoni ġdida għal Effentora, sabiex testendi l-kura għal uġigħ li jissokta (uġigħ li jibqa' jinħass) anki wara li pazjenti adulti b'uġigħ persistenti kroniku (fit-tul) minn kawżi li mhumiex kanċer, ikunu ħadu mediċina kontrih.
English: The effects of Effentora were compared with those of placebo (a dummy treatment) in 79 patients with neuropathic pain (pain due to nerve damage) in one study, and in 77 patients with lowback pain in a second study.
Maltese: L-effetti ta' Effentora tqabblu ma' dawk ta' plaċebo (kura finta) f'79 pazjent b'uġigħ newropatiku (uġigħ dovut għal ħsara fin-nervituri) fi studju wieħed, u f'77 pazjent b'uġigħ fil-parti t'isfel tad-dahar f'tieni studju.
English: The duration of treatment was determined by the time needed by each patient to control 9 episodes of breakthrough pain within a 21-day period.
Maltese: It-tul tal-kura ġie stabbilit mill-ħin meħtieġ minn kull pazjent għallkontroll ta' 9 episodji ta' uġigħ li jissokta fi żmien perjodu ta' 21 jum.
English: What was Effentora expected to be used for?
Maltese: Kif kien mistenni li jintuża Effentora?
English: The applicant presented data from 3 main studies in adults with breakthrough pain already using opioids.
Maltese: L-applikant ippreżenta dejta minn 3 studji prinċipali f'adulti b'uġigħ li jissokta li jkunu diġà qegħdin jużaw opjojdi.
English: What is happening with Effentora for the treatment ‘breakthrough' pain in adults with cancer?
Maltese: X'inhu jiġri b'Effentora għall-kura ta' uġigħ li jissokta f'adulti b'kanċer?
English: The third study, which lasted for 12 weeks, looked at the effects of Effentora in 148 patients with non-cancer-related longterm pain.
Maltese: It-tielet studju, li dam 12-il ġimgħa, ħares lejn l-effetti ta' Effentora fuq 148 pazjent b'uġigħ għal żmien twil mhux relatat ma' kanċer.
English: How was Effentora expected to work?
Maltese: Għalxiex kien mistenni li jintuża Effentora?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Effentora could not have been approved for the treatment of breakthrough pain in adults with long-term pain other than cancer pain.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u tat-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Effentora ma setax jiġi approvat għall-kura ta' uġigħ li jissokta f'adulti b'uġigħ fit-tul minn kawżi li mhumiex kanċer.
English: In Effentora, it is given as a buccal tablet, so that fentanyl is absorbed through the lining of the mouth.
Maltese: F'Effentora, jingħata bħala pillola bokkali, sabiex fentanyl jiġi assorbit permezz tar-rita tal-ħalq.
English: The CHMP considered that, although the use of Effentora is accepted in cancer patients who have limited survival, further data were needed to support its safe use in adults with non-cancer-related pain, who have normal life expectancy and may need long-term treatment.
Maltese: Jekk inti tinsab fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qiegħed jagħtihielek.
English: Effentora was also expected to be used to treat breakthrough pain in adults with long-term persistent pain from causes other than cancer, who were already receiving regular treatment with opioids to control their persistent pain.
Maltese: Effentora kien mistenni wkoll li jintuża f'uġigħ li jissokta f'adulti b'uġigħ persistenti fit-tul li jkun ġej minn kawżi li mhumiex kanċer, li diġà kienu qed jirċievu kura regolari b'opjojdi sabiex jikkontrollaw luġigħ persistenti tagħhom.
English: Content Package size Withdrawal Period
Maltese: Kontenut Daqs tal-pakkett
English: Target species
Maltese: Perjodu ta' Tiżmin
English: The marketing authorisation was renewed on 12 March 2004 and on 12 March 2009.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-12 ta' Marzu 2004 u fit-12 ta' Marzu 2009.
English: It is available as capsules (white and brown: 5 mg; white: 10 mg).
Maltese: Huwa disponibbli f'kapsuli (bojod u kannella: 5 mg; bojod: 10 mg).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SONATA EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) SONATA Sommarju tal-EPAR għall-pubbliku
English: Sonata has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients.
Maltese: Sonata ġie studjat f'total ta' 14-il studju, li involvew kważi 3,500 adult u pazjenti anzjani.
English: This summary was last updated in 03-2009.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 03-2009.
English: Sonata is a medicine that contains the active substance zaleplon.
Maltese: Sonata huwa mediċina li fiha s-sustanza attiva zaleplon.
English: The marketing authorisation holder is Meda AB.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Meda AB.
English: The active substance in Sonata, zaleplon, belongs to a group of medicines that are related to the benzodiazepines.
Maltese: Is-sustanza attiva f'Sonata, zaleplon, tapartjeni għal grupp ta' mediċini li huma relatati malbenzodiazepines.
English: The most common side effects with Sonata (seen in between 1 and 10 patients in 100) are amnesia (memory problems), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness) and dysmenorrhoea (painful menstruation).
Maltese: L-aktar effetti sekondarji komuni b'Sonata (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma amnesija (problemi bil-memorja), parestesija (sensazzjonijiet anormali bħal tingiż), ħedla tan-ngħas u dismenorrea (mestrwazzjoni li tikkawża l-uġigħ).
English: It must not be used in patients with severe liver or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathing disorders), or in patients under 18 years of age.
Maltese: M'għandux jintuża f'pazjenti bi problemi severi fil-fwied jew il-kliewi, bissindromu ta' apnea tal-irqad (waqfien frekwenti tan-nifs waqt l-irqad), mijastenija gravis (marda li tikkawża indeboliment tal-muskoli) jew insuffiċjenza respiratorja severa (disturbi tan-nifs), jew f'pazjenti ta' taħt it-18-il sena.
English: What is Sonata?
Maltese: X'inhu Sonata?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sonata on 12 March 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Sonata fit-12 ta' Marzu 1999.
English: The powder in Sonata capsules is coloured with an intense dark blue dye, to prevent it being given to someone without their knowledge.
Maltese: It-trab fil-kapsuli Sonata huwa kkulurit b'żebgħa blu skura qawwija, biex jiġi evitat li jingħata lil xi ħadd mingħajr ma jkun jaf.
English: It is a gamma-amino butyric acid (GABA) receptor agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them.
Maltese: Huwa agonist tar-riċetturi tal-aċdu butiriku gamma-amino (GABA- gamma-amino butyric acid receptor agonist), li jfisser li jeħel mar-riċetturi tan-newrotrasmettituri tal-GABA u jattivahom.
English: What is the risk associated with Sonata?
Maltese: X'inhu r-riskju assoċjat ma' Sonata?
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Maltese: Newrotrasmettituri bħal GABA huma kimiċi li jippermettu liċ-ċelluli tan-nervituri jikkomunikaw bejniethom.
English: In elderly patients, the time taken to fall asleep was often decreased with Sonata 5 mg and was always decreased with Sonata 10 mg, when they were compared with placebo in the two-week studies.
Maltese: F'pazjenti anzjani, iż-żmien li damu biex jorqdu ħafna drabi naqas b'Sonata 5 mg u naqas dejjem b'Sonata 10 mg, meta mqabbel mal-plaċebo fl-istudji ta' ġimagħtejn.
English: Why has Sonata been approved?
Maltese: Għaliex ġie approvat Sonata?
English: Five of these studies were comparative: Sonata was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia).
Maltese: Sonata tqabbel ma' plaċebo (trattament finta) jew ma' zolpidem jew triazolam (mediċini oħra użata fl-insonnja).
English: How has Sonata been studied?
Maltese: Kif ġie studjat Sonata?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata's benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Sonata huma akbar mir-riskji tiegħu għat-trattament ta' pazjenti bl-insonnja li jsibuha diffiċli biex jorqdu, meta id-disturb ikun sever, b'indeboliment jew li jikkawża għeja kbira lill-individwi.
English: Sonata 10 mg was more effective than placebo in decreasing the time taken to fall asleep and increasing time spent asleep during the first half of the night.
Maltese: Sonata jintuża fit-trattament ta' adulti li jbatu mill-insonnja li jsibuha diffiċli biex jorqdu.
English: Zaleplon is chemically different from the benzodiazepines, but it acts on the same receptors in the brain.
Maltese: Zaleplon huwa kimikament differenti mill-benzodiazepines, iżda jaħdem fuq l-istess riċetturi fil-moħħ.
English: The Committee recommended that Sonata be given marketing authorisation.
Maltese: L-EPAR sħiħ għal Sonata jista' jiġi kkonsultat hawn.
English: For the full list of all side effects reported with Sonata, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Sonata, ara l-Fuljett ta' Tagħrif.
English: Anakinra - Thrombocytopenia (EPITT no 18337)
Maltese: Anakinra - Tromboċitopenija (EPITT nru 18337)
English: Blood and lymphatic system disorders Frequency ‘common': thrombocytopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Frekwenza ‘komuni': tromboċitopenija
English: Summary of Product Characteristics: Section 4.8 - Undesirable effects:
Maltese: Sommarju tal-Karatteristiċi tal-Prodott: Sezzjoni 4.8 - Effetti mhux mixtieqa:
English: In clinical studies in RA and CAPS patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Maltese: Fl-istudji kliniċi fuq pazjenti bir-RA u l-CAPS, it-tromboċitopenija ġiet rappurtata f'1.9% tal-pazjenti kkurati meta mqabbel ma' 0.3% tal-grupp tal-plaċebo.
English: Adopted at the 5-8 October 2015 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-5-8 ta' Ottubru 2015
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/661880/2015
Maltese: Kliem ġdid tal-informazzjoni dwar il-prodott - Siltiet mir-rakkomandazzjonijiet tal-PRAC dwar is-sinjali EMA/PRAC/680921/2015
English: The thrombocytopenias have been mild, i.e. platelet counts have been >75 x109/l.
Maltese: It-tromboċitopeniji kienu ħfief, jiġifieri in-numru ta' pjastrini kien >75 x109/l.