FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore concluded that the benefits of Yvidually outweigh its risks, and therefore the marketing authorisation for Yvidually should be granted in all concerned Member States.
Maltese: Għalhekk, is-CHMP ikkonkluda li l-benefiċċji ta' Yvidually huma akbar mir-riskji tiegħu, u għaldaqstant, l-awtorizzazzjoni għat-tqegħid fis-suq għal Yvidually għandha tingħata fl-Istati Membri kkonċernati kollha.
English: Based on evaluation of the available data and the scientific discussion within the Committee, the CHMP concluded that the contraceptive effectiveness during an extended use had been demonstrated.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli u tad-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP ikkonkluda li l-effikaċja tal-kontraċettiv matul użu estiż intweriet.
English: Pioglitazone
Maltese: Pijoglitażonu
English: It is available as tablets (15, 30 and 45 mg).
Maltese: Jiġi f'pilloli (15, 30 u 45 mg).
English: The full EPAR for Glidipion 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 08-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f':08-2012.
English: Glidipion is a ‘generic medicine'.
Maltese: Glidipion huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Glidipion on 15 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Glidipion valida fl-Unjoni Ewropea kollha fil-15 ta' Marzu 2012.
English: This is a summary of the European public assessment report (EPAR) for Glidipion.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Glidipion.
English: The recommended starting dose of Glidipion is 15 or 30 mg once a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Glidipion hija 15 jew 30 mg darba kuljum.
English: The CHMP concluded that, in accordance with EU requirements, Glidipion has been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Glidipion għandu kwalità komparabbli u li huwa bijoekwivalenti għal Actos.
English: Glidipion is a medicine that contains the active substance pioglitazone.
Maltese: Glidipion huwa mediċina li fiha s-sustanza attiva pijoglitażonu.
English: This means that Glidipion is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Glidipion huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: The active substance in Glidipion, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Glidipion, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jibda jagħmel użu aħjar mill-insulina li jipproduċi.
English: Why has Glidipion been approved?
Maltese: Għaliex ġie approvat Glidipion?
English: Because Glidipion 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 Glidipion huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Glidipion is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Glidipion huwa mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Actos.
English: Glidipion can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Maltese: Glidipion jista' jintuża wkoll kemm mal-metaformina u kemm mas-sulfonilurea fuq pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti minkejja l-għoti ta' terapija doppja mill-ħalq (‘terapija trippla').
English: Glidipion can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Maltese: Glidipion jintuża waħdu fuq pazjenti li ma jistgħux jieħdu l-metformina (mediċina antidijabetika oħra) Glidipion jista' jintuża wkoll flimkien mal-metformina f'pazjenti li ma jkunux jistgħu jiġu kkontrollati b'mod sodisfaċenti bil-metformin biss, jew mas-sulfonilurea (tip ieħor ta' mediċina antidijabetika) meta l-metformina ma tkunx tista' tintuża (‘terapija doppja').
English: Glidipion is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Glidipion jintuża għall-kura tad-dijabete tat-tip 2 f'adulti (minn 18-il sena 'l fuq), b'mod partikolari dawk b'piż eċċessiv.
English: Glidipion should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Maltese: Glidipion m'għandux jintuża fuq pazjenti bid-dijaliżi (teknika tat-tisfija tad-demm użata f'nies b'mard fil-kliewi).
English: What is Glidipion?
Maltese: X'inhu Glidipion?
English: Therefore, the CHMP's view was that, as for Actos, the benefits outweigh the identified risks.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Actos, il-benefiċċji huma akbar mir-riskji identifikati.
English: What is the risk associated with Glidipion?
Maltese: X'inhu r-riskju assoċjat ma' Glidipion?
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Maltese: Jista' jenħtieġ li din iddoża tiżdied wara ġimgħa jew ġimagħtejn sa 45 mg darba kuljum jekk ikun meħtieġ kontroll aħjar filglukożju fid-demm (zokkor).
English: How has Glidipion been studied?
Maltese: Kif ġie studjat Glidipion?
English: Other information about Glidipion
Maltese: Għalxiex jintuża Glidipion?
English: Pregnancy.
Maltese: Tqala.
English: Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
Maltese: Immunodefiċjenza tal-umuri jew ċellulari (primarja jew akkwistata) qawwija, eż., immunodefiċjenza kkombinata qawwija, agammaglobulinemija u AIDS jew infezzjoni bl-HIV bis-sintomi jew perċentwal ta' limfoċiti T CD4+ speċifiku għall-età fi tfal inqas minn 12-il xahar: CD4+ <25%; tfal bejn 12-il xahar u 35 xahar: CD4+ <20%; tfal bejn 36 u 59 xahar: CD4+ <15% (ara sezzjoni 4.4).
English: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g. asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Maltese: It-tilqim jista' jiġi kkunsidrat f'pazjenti b'defiċjenzi immuni magħżula fejn il-benefiċċji jkunu aktar mirriskji (pazjenti bl-HIV mingħajr sintomi, defiċjenzi tas-sottoklassi
English: The wording below should be inserted:
Maltese: TAL-PRODOTT]:
English: Even if a theoretical risk cannot be excluded yet, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with rubella containing vaccines.
Maltese: Anke jekk sa issa ma jistax jiġi eskluż riskju teoretiku, ma ġie rrappurtat l-ebda każ ta' sindrome konġenitali tal-ħosba Ġermaniża f'aktar minn 3500 mara suxxettibbli li ma kinux għadhom jafu li kienu fl-istadji bikrija tat-tqala meta tlaqqmu b'vaċċini li kien fihom il-ħosba Ġermaniża.
English: Section 4.3 Contraindications The wording regarding pregnancy and immunocompromised patients should read as follows:
Maltese: Sezzjoni 4.3 Kontra-indikazzjonijiet Il-kliem dwar it-tqala u l-pazjenti immunokompromessi għandu jinqara hekk:
English: You or your child should be closely monitored as the responses to the vaccines may not be sufficient to ensure a protection against the illness (see section 2 “Do not use [PRODUCT NAME]”)
Maltese: Inti jew it-tifel/tifla tiegħek għandkom tiġu mmonitorjati mill-qrib minħabba li r-risponsi għat-tilqim jistgħu ma jkunux biżżejjed biex tiġi aċċertata protezzjoni kontra l-marda (ara sezzjoni 2 “Tużax [ISEM TALPRODOTT]”)
English: Section 4.6 Fertility, pregnancy and lactation The wording regarding pregnancy should read as follows:
Maltese: Sezzjoni 4.6 Fertilità, tqala u treddigħ Il-kliem dwar it-tqala għandu jinqara hekk:
English: These patients should be monitored carefully for signs of measles, parotitis and rubella.
Maltese: Waqt dan iż-żmien inti għandek tuża metodu effettiv ta' kontraċezzjoni biex tevita t-tqala.
English: These patients should be monitored carefully for signs of parotitis.
Maltese: Dawn il-pazjenti għandhom jiġu immonitorjati b'attenzjoni għal sinjali ta' parotite.
English: Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles, mumps, rubella and varicella containing vaccines
Maltese: Amendi li għandhom jiġu inklużi fis-sezzjonijiet rilevanti tas-sommarju tal-karatteristiċi talprodott għat-tilqim multivalenti li fih il-ħosba, il-gattone, il-ħosba Ġermaniża u l-ġidri r-riħ
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Maltese: Anness III Amendi tas-sezzjonijiet rilevanti fis-sommarji tal-karatteristiċi tal-prodott u fil-fuljetti ta' tagħrif
English: - if you or your child has any illness (such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)) or takes any medicine that weakens the immune system.
Maltese: -jekk inti jew it-tifel/tifla tiegħek għandkom xi mard (bħal Virus tal-Immunodefiċjenza Umana (HIV) jew Sindrome ta' Immunodefiċjenza Akkwistata (AIDS) jew tieħdu xi mediċini li jdgħajfu s-sistema immuni.
English: Amendments to be included in the relevant sections of the package leaflet for multivalent measles, mumps, rubella and varicella containing vaccines 2.
Maltese: Amendi li għandhom jiġu inklużi fis-sezzjonijiet rilevanti tal-fuljett ta' tagħrif għat-tilqim multivalenti li fih il-ħosba, il-gattone, il-ħosba Ġermaniża u l-ġidri r-riħ 2.
English: Further information on Betaferon can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/betaferon.
Maltese: Aktar informazzjoni dwar Betaferon tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/betaferon.
English: Betaferon received a marketing authorisation valid throughout the EU on 30 November 1995.
Maltese: Betaferon ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-30 ta' Novembru 1995.
English: Other information about Betaferon
Maltese: Informazzjoni oħra dwar Betaferon
English: Betaferon is a medicine used to treat adults who have multiple sclerosis (MS).
Maltese: Betaferon huwa mediċina li tintuża għall-kura ta' adulti bi sklerożi multipla (MS).
English: Betaferon contains the active substance interferon beta-1b.
Maltese: Betaferon fih is-sustanza attiva interferon beta-1b.
English: Betaferon was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Betaferon developed MS, compared with 45% of those who received placebo.
Maltese: Betaferon intwera li jnaqqas ir-riskju għall-iżvilupp ta' MS klinikament definita: 28 % tal-pazjenti li ngħataw Betaferon żviluppaw MS, meta mqabbla ma' 45 % ta' dawk li ngħataw il-plaċebo.
English: Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo.
Maltese: Betaferon ġie studjat ukoll fuq 1,657 pazjent f'żewġ studji ta' pazjenti b'MS progressiva sekondarja li kienu kapaċi jimxu, fejn tqabbel ma' plaċebo.
English: Treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms given every other day.
Maltese: Il-kura għandha tinbeda b'62.5 mikrogramma (kwart tad-doża) jum iva u jum le, u tiżdied progressivament fuq 19-il jum biex tintlaħaq id-doża rakkomandata ta' 250 mikrogramma li tingħata jum iva u jum le.
English: The most frequent side effects with Betaferon are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Betaferon huma sintomi li jixbhu dawk tal-influwenza (inkluż deni, tkexkix ta' bard, uġigħ fil-ġogi, telqa [tħossok ma tiflaħx], għeriq, uġigħ ta' ras u wġigħ fil-muskoli) u reazzjonijiet fis-sit tal-injezzjoni.
English: Betaferon is used in patients:
Maltese: Betaferon jintuża fuq pazjenti:
English: What are the risks associated with Betaferon?
Maltese: X'inhuma r-riskji assoċjati ma' Betaferon?
English: How is Betaferon used?
Maltese: Kif jaħdem Betaferon?
English: Betaferon is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Maltese: Betaferon jiġi bħala trab u solvent li jitħalltu biex isiru soluzzjoni li tipprovdi doża ta' 250 mikrogramma.
English: The active substance in Betaferon is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Maltese: Is-sustanza attiva f'Betaferon hija l-proteina interferon beta-1b, waħda minn grupp ta' interferoni li tista' tiġi prodotta b'mod naturali mill-ġisem biex tgħinu jiġġieled kontra l-viruses u attakki oħra.
English: In both studies, Betaferon showed a reduction (30%) in the number of clinical relapses.
Maltese: Fiż-żewġ studji, Betaferon wera tnaqqis (30 %) flgħadd ta' rikaduti kliniċi.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Maltese: FlMS, is-sistema immunitarja (id-difiżi naturali tal-ġisem) ma taħdimx tajjeb u tattakka partijiet missistema nervuża ċentrali (il-moħħ, l-ispina dorsali u n-nerv ottiku [nerv li jibgħat sinjali mill-għajn lejn il-moħħ]), u tikkawża infjammazzjoni li tagħmel ħsara lin-nervituri u lill-kisja ta' madwarhom.
English: Betaferon was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27.
Maltese: Betaferon kien iktar effettiv mill-plaċebo fit-tnaqqis tal-għadd ta' rikaduti annwali: il-pazjenti li kienu qed jingħataw il-mediċina kellhom medja ta' 0.84 rikaduta fis-sena, mentri l-pazjenti fuq plaċebo kellhom 1.27.
English: The exact way that Betaferon works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Maltese: Għadu mhuwiex magħruf il-mod eżatt kif jaħdem Betaferon fl-MS iżda s-sustanza attiva, interferon beta-1b, tidher li tikkalma s-sistema immunitarja, u tipprevjeni rikaduti ta' MS.
English: Betaferon was also studied in 487 patients with a single demyelinating event, who received either Betaferon or placebo for two years.
Maltese: Betaferon ġie studjat ukoll fuq 487 pazjent b'avveniment uniku ta' demijelinazzjoni, li ngħataw Betaferon jew plaċebo għal sentejn.
English: As for all medicines, data on the use of Betaferon are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Betaferon hija ssorveljata kontinwament.
English: Betaferon was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where it was compared with placebo (a dummy treatment).
Maltese: Betaferon ġie studjat fuq perjodu ta' sentejn fuq 338 pazjent b'MS b'rikaduti u b'remissjonijiet li kienu kapaċi jimxu mingħajr għajnuna, fejn tqabbel ma' plaċebo (kura finta).
English: One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%).
Maltese: Wieħed miż-żewġ studji wera dewmien sinifikanti fiżżmien għall-progressjoni tad-diżabilità (tnaqqis tar-riskju ta' 31 % minħabba Betaferon) u fiż-żmien fejn il-pazjenti jkollhom jibdew jużaw siġġu tar-roti (39 %).
English: • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Maltese: • li għandhom MS progressiva sekondarja (it-tip ta' MS li sseħħ wara
English: For the full list of side effects and restrictions with Betaferon, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Betaferon, ara l-fuljett ta' tagħrif.
English: • who have experienced the signs of MS for the first time, and these are severe enough to need treatment with injected corticosteroids (anti-inflammatory medicines).
Maltese: • li esperjenzaw is-sinjali ta' MS għall-ewwel darba, u dawn huma severi biżżejjed biex jeħtieġu kura b'kortikosterojdi injettati (mediċini antiinfjammatorji).
English: What benefits of Betaferon have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Betaferon li ħarġu mill-istudji?
English: Side effects reported with Betaferon are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Betaferon huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Prins Bernhardplein 200 1097JB Amsterdam Netherlands
Maltese: Prins Bernhardplein 200 1097JB Amsterdam l-Olanda
English: - The active substance is miglustat.
Maltese: - Is-sustanza attiva hi miglustat.
English: ATC Code: A16AX06
Maltese: A16AX06
English: Hard capsule 84 capsules 84x1 capsules
Maltese: Kapsula iebsa 84 kapsula 84x1 kapsula
English: Quinto dè Stampi Rozzano (MI)
Maltese: Quinto de Stampi Rozzano (MI)
English: 20089 Quinto dè Stampi - Rozzano (MI)
Maltese: 20089 Quinto dè Stampi - Rozzano (MI) Italja
English: Capsule content Magnesium stearate
Maltese: Kontenut tal-kapsula Magnesium stearate
English: Titanium dioxide (E171)
Maltese: Dijossidu tat-titanju (E171)
English: In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 μM.
Maltese: In vitro, glucosylceramide synthase huwa inibit minn miglustat b'IC50 ta' 20-37 µM.
English: {MM/YYYY}
Maltese: <{XX/SSSS}>
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products.
Maltese: Prodotti oħra ta 'l-uġigħ ta' l-ikel u tal-metaboliżmu, diversi prodotti ta 'l-apparat alimentari u metaboliżmu
English: PCTFE/PVC and Aluminium blister containing 12 (perforated unit dose) or 21 (non-perforated) capsules.
Maltese: Folja tal-PCTFE/PVC u tal-Aluminju li fih 12-il (doża unità perforata) jew 21 kapsula (mhux imtaqqbin).
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia headache, dizziness
Maltese: Newropatija periferali, ataksja, amneżija, parasteżija, ipoestesija, uġigħ ta' ras, sturdament
English: - The other ingredients are magnesium stearate, gelatine, titanium dioxide (E171), printing ink (consisting of black iron oxide (E172), propylene glycol (E1520) potassium hydroxide, shellac).
Maltese: - Is-sustanzi l-oħra huma magnesium stearate, ġelatina, dijossidu tat-titanju (E171), linka għallistampar (li tikkonsisti f'ossidu tal-ħadid iswed (E172), propilengliċ (E1520) idrossidu tal potassju, shellac).
English: Date of first authorisation: 18 February 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta 'Frar 2019
English: The capsules are presented in PCTFE/PVC and Aluminium blister, ain pack size of 84 capsules in non-perforated blisters and 84x1 capsules in perforated unit dose blisters.
Maltese: Il-kapsuli huma ppreżentati f'pakketti tal-folji PCTFE/PVC u Aluminum, f'pakketti ta' 84 kapsula f'folji mhux perforati u 84x1 kapsula f'folji perforati ta' doża ta' unità waħda.
English: Depression, insomnia, libido decreased
Maltese: Depressjoni, nuqqas ta' rqad, tnaqqis fil-libido
English: Black iron oxide (E172) Potassium Hydroxide Shellac
Maltese: Idrossidu tal-potassju Shellac
English: Miglustat Dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Maltese: Miglustat Dipharma huwa indikat għall-kura ta' manifestazzjonijiet newroloġiċi progressivi f'pazjenti adulti u pazjenti pedjatriċi li għandhom il-marda Niemann-Pick ta' tip Ċ (ara sezzjonijiet 4.4, u 5.1).
English: These data suggest a decrease in CL/F by at least 70% in patients with severe renal impairment.
Maltese: CL/F ta' mill-inqas 70% f'pazjenti b'indeboliment sever tal-kliewi.
English: In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
Maltese: F'analiżi miġbura ta' tagħrif mhux ikkontrollat, punteġġi Z tad-densità tal-minerali fl-għadam fl-ispina lombari u flgħonq femorali żdiedu b'aktar minn 0.1 unità mil-linja bażi f'27 (57%) u 28 (65%) tal-pazjenti b'qisien lonġitudinali tad-densità ta' l-għadam.
English: Data to support safety and efficacy of miglustat in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Maltese: Tagħrif li jsostni s-sigurtà u l-effikaċja ta' miglustat fil-marda ta' Niemann-Pick ta' tip Ċ ġej minn prova klinika open-label prospettiva u minn servej retrospettiv.
English: Common side effects - may affect up to 1 in 10 people Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).
Maltese: Effetti komuni - jistgħu jaffettwa sa 1 minn kull 10 persuni Effetti sekondarji komuni tal-kura jinkludu uġigħ ta' ras, sturdament, parasteżija (tnemmin jew tirżiħ), koordinazzjoni mhux normali, ipoestesija (sensazzjoni tal-mess imnaqqsa), dispepsja (ħruq ta' stonku), tqalligħ (tħossok imdardar), stitikezza u rimettar, nefħa jew skomdu fl-addome (stonku) u tromboċitopenja (livelli mnaqqsa ta' plejtlits tad-demm).
English: A mean increase in haemoglobin concentration of 0.26 g/dl and a mean platelet count increase of 8.29 × 109/l were observed.
Maltese: Żjieda medja fil konċentrazzjoni ta' l-emoglobina ta' 0.26 g/dl u żjieda medja fl-għadd tal-plejtlets ta' 8.29 × 109/l kienu osservati.
English: In 11 clinical trials in different indications 247 patients were treated with miglustat at doses of 50-200 mg t.i.d.
Maltese: Fi 11-il prova klinika dwar indikazzjonijiet differenti, 247 pazjent kienu kkurati b'miglustat b'dożaġġ ta' 50-200 mg t.i.d. għal tul medju ta' 2.1 sena.
English: Tabulated list of adverse reactions Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000).
Maltese: ≥1/10, komuni: ≥1/100, <1/10, mhux komuni: ≥1/1,000 sa <1/100, rari: