FrancophonIA/ELRC3.0 huggingface dataset:
English: If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
Maltese: Jekk il-pazjenti huma ttrasferiti minn mediċina kontra d-dijabete għal oħra, id-doża tal-bidu rakkomandata hija ta' 1 mg.
English: The raised insulin levels returned to normal after the meal.
Maltese: Illivelli li kienu telgħu tal-insulina reġgħu marru lura għan-normal wara l-ikla.
English: How has Prandin been studied?
Maltese: Kif ġie studjat Prandin?
English: In the study where Prandin was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
Maltese: Fl-istudju fejn Prandin ġie miżjud ma' metaformin, l-effetti taż-żewġ mediċini kienu talanqas addittivi (ekwivalenti għall-effetti taż-żewġ mediċini miżjuda flimkien).
English: It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels).
Maltese: Ma għandux jintuża wkoll f'pazjenti b'ketoaċidożi dijabetika (livelli għoljin ta' ketoni [aċidi] fid-demm), f'pazjenti bi problemi serji fil-fwied jew f'pazjenti li jkunu qegħdin jieħdu gemfibrozil ukoll (mediċina wżata biex tnaqqas il-livelli ta' xaħam fid-demm).
English: The main studies compared Prandin with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide).
Maltese: L-istudji ewlenin qabblu Prandin ma' mediċini oħrajn użati f'dijabete tat-tip 2 (glibenclamide, glipizide jew gliclazide).
English: What is Prandin used for?
Maltese: X'inhu Prandin?
English: Prandin is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Maltese: Prandin jintuża f'pazjenti li għandhom dijabete tat-tip 2 (dijabete mhux dipendenti fuq l-insulina).
English: Prandin produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal.
Maltese: Prandin ipproduċa rispons tajjeb tal-insulina għal ikla fi żmien 30 minuta mid-dożaġġ f'pazjenti b'dijabete tat-tip 2, li wassal għal effett ta' tnaqqis tal-livell ta' glukożju fid-demm matul l-ikla.
English: What is the risk associated with Prandin?
Maltese: Għal xiex jintuża Prandin?
English: Prandin may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Maltese: Prandin jista' jintuża wkoll ma' metformin (mediċina oħra kontra ddijabete) f'pazjenti b'dijabete tat-tip 2 li l-livelli ta' glukożju fid-demm tagħhom m'humiex ikkontrollati b'mod sodisfaċenti b'metaformin waħdu.
English: Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Maltese: Prandin jgħin lill-frixa tipproduċi aktar insulina f'ħinijiet l-ikel u jintuża biex jikkontrolla d-dijabete tat-tip 2.
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Maltese: Jintuża flimkien ma' dieta u eżerċizzju biex ibaxxi l-livelli ta' glukożju (zokkor) fid-demm f'pazjenti li l-ipergliċemija (livelli għoljin ta' glukożju fid-demm) tagħhom ma tistax tiġi kkontrollata b'dieta, tnaqqis fil-piż u eżerċizzju.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
Maltese: L-istudji kejlu l-livell ta' sustanza fid-demm imsejħa emoglobina glikosilata (HbA1c) li jagħti indikazzjoni ta' kemm il-glukożju fid-demm ikun qiegħed jiġi kkontrollat tajjeb.
English: Further information on Miglustat Dipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
Maltese: ema.europa.eu/medicines/human/EPAR/miglustat-dipharma.
English: Miglustat Dipharma is a ‘generic medicine'.
Maltese: Miglustat Dipharma huwa ‘mediċina ġenerika'.
English: Miglustat Dipharma received a marketing authorisation valid throughout the EU on 18 February 2019.
Maltese: Miglustat Dipharma ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Frar 2019.
English: This overview was last updated in 06-2019
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'06-2019.
English: • adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease.
Maltese: • adulti (minn 18-il sena ‘l fuq) b'marda ta' Gaucher tat-tip 1 minn ħafifa sa moderata.
English: These include loss of coordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
Maltese: Dawn jinkludu telf ta' koordinazzjoni, problemi b'movimenti fl-għajnejn “rapidi” (rapidi) li jistgħu jwasslu għal vista batuta, żvilupp ittardjat, diffikultà biex tibla', tnaqqis fl-issodar tal-muskoli, aċċessi u diffikultajiet ta' tagħlim.
English: Other information about Miglustat Dipharma
Maltese: Informazzjoni oħra dwar Miglustat Dipharma
English: The active substance in Miglustat Dipharma, miglustat, blocks an enzyme called glucosylceramide synthase.
Maltese: Is-sustanza attiva f'Miglustat Dipharma, il-miglustat, timblokka enzima msejħa sintażi talglukożilċeramid.
English: Miglustat Dipharma is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
Maltese: Miglustat Dipharma jintuża f'pazjenti li ma jistgħux jirċievu l-kura standard tat-terapija ta' sostituzzjoni talenzima (ERT);
English: Because Miglustat Dipharma 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 Miglustat Dipharma 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: This enzyme is involved in the first step of the production of glucosylceramide.
Maltese: Din l-enzima hija involuta fl-ewwel pass tal-produzzjoni tal-glukożilċeramid.
English: Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Dipharma.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fil-marda Gaucher bil-mediċina ta' referenza, Zavesca, u ma għandhomx għalfejn jiġu ripetuti għal Miglustat Dipharma.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument bil-mistoqsijiet u ttweġibiet hawnhekk.
English: Miglustat Dipharma is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Maltese: Miglustat Dipharma jintuża fil-kura tas-sintomi newroloġiċi tal-marda (sintomi li jaffettwaw il-moħħ u n-nervituri).
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Ilkumpanija wettqet ukoll studju li wera li hija “bijoekwivalenti” għall-mediċina ta' referenza.
English: Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Maltese: Pazjenti b'din il-marda m'għandhomx enzima msejħa glukoċerebrosidażi, li tirriżulta fi glikosfingolipidi li jissejjaħ il-glukożilċeramid li jiżviluppa f'partijiet differenti tal-ġisem, bħall-milsa, fwied u għadam.
English: What are the benefits and risks of Miglustat Dipharma?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Miglustat Dipharma?
English: As for all medicines, data on the use of Miglustat Dipharma are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Miglustat Dipharma hija ssorveljata kontinwament.
English: • patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Maltese: • pazjenti ta' kull età bil-marda ta' Niemann-Pick tat-tip Ċ, marda potenzjalment fatali fejn lglikosforingolipidi jiżviluppaw fiċ-ċelloli tal-moħħ u xi mkien ieħor fil-ġisem.
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Maltese: Meta tipprevjeni lill-enzima milli taħdem, il-miglustat tista' tnaqqas il-produzzjoni tal-glukożilċeramid fiċċelloli, b'hekk jitnaqqsu s-sintomi tal-marda ta' Gaucher tat-tip 1.
English: This means that Miglustat Dipharma contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Maltese: Dan ifisser li Miglustat Dipharma fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-UE msejħa Zavesca.
English: Miglustat Dipharma is available as 100 mg capsules to be taken by mouth.
Maltese: Miglustat Dipharma jiġi bħala kapsuli ta' 100 mg li għandhom jittieħdu mill-ħalq.
English: Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Dipharma outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, lopinjoni tal-Aġenzija kienet li, bħal fil-każ ta' Zavesca, il-benefiċċju ta' Miglustat Dipharma huwa akbar mir-riskju identifikat u jista' jiġi awtorizzat għall-użu fl-UE.
English: • Ancillary treatment of Raynaud's syndrome
Maltese: • Kura anċillari tas-sindrome ta' Raynaud
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)
Maltese: • Kura anċillari tal-klawdikazzjoni intermittenti f'marda okklussiva arterjali periferali sintomatika (PAOD Fażi
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Maltese: • Kura anċillari tat-tnaqqis tal-akutezza viżiva u disturbi fil-kamp viżiv presumibbilment ta' oriġini vaskulari
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Maltese: • Kura għas-sintomi ta' indeboliment konoxxittiv u newrosensorjali pataloġiku kroniku fl-anzjani (għajr il-marda tal-Alzheimer u dimenzja oħra)
English: B. Package Leaflet
Maltese: II)
English: • Prophylaxis of migraine headache All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Maltese: Ir-referenzi kollha għall-indikazzjonijiet imsemmija hawn fuq għandhom jitneħħew mis-sezzjonijiet relevanti li jibqa' tas-sommarji tal-karatteristiċi tal-prodott.
English: • Acute retinopathies of vascular origin
Maltese: • Kura għas-sintomi ta' insuffiċjenza veno-limfatika
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Maltese: Anness III Emendi għas-sezzjonijiet relevanti tas-sommarji tal-karatteristiċi tal prodott u l-fuljetti ta' tagħrif
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Maltese: [l-indikazzjonijiet approvati attwalment hawn taħt għandhom jitħassru (il-formolazzjoni tal-kliem speċifika tal-indikazzjoni tista' tvarja minn prodott għal prodott)]
English: On 19 December 2012, the European Medicines Agency was made aware of preliminary results from a large randomised clinical study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE) designed to assess the incremental benefit of extended release nicotinic acid (ERN)/laropiprant (LRPT) versus placebo in over 25,673 high-risk patients.
Maltese: Fid-19 ta' Diċembru 2012, l-Aġenzija Ewropea għall-Mediċini ġiet mgħarrfa bir-riżultati preliminarji minn studju kliniku kbir randomizzat (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events - HPS2-THRIVE) li kien iddisinjat biex jevalwa l-benefiċċju inkrimentali ta' aċidu nikotiniku b'rilaxx estiż (ERN)/laropiprant (LRPT) kontra plaċebo f'aktar minn 25,673 pazjent f'riskju għoli.
English: • The PRAC reviewed the totality of the available data, including studies and publications on acipimox, the MAH responses as well as relevant data on nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies;
Maltese: • Il-PRAC irreveda t-totalità tad-dejta disponibbli, inklużi studji u pubblikazzjonijiet dwar acipimox, it-tweġibiet tal-MAH, kif ukoll dejta rilevanti dwar aċidu nikotiniku, inklużi l-istudji AIM-HIGH u HPS2-THRIVE;
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for nicotinic-acid and related substances initiated by Denmark and decided to restrict the scope of the procedure to products containing acipimox, the only high-dose nicotinic acid-related substance indicated in lipid disorders authorised in the EU;
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE bħala riżultat taddejta ta' farmakoviġilanza għal aċidu nikotiniku u sustanzi relatati mibdija mid-Danimarka u ddeċieda li jirrestrinġi l-kamp ta' applikazzjoni tal-proċedura għal prodotti li fihom acipimox, lunika sustanza f'doża għolja indikata f'disturbi fil-lipidi awtorizzata fl-UE;
English: Grounds for PRAC recommendation
Maltese: Rakkomandazzjoni tal-PRAC
English: The CMDh considered the below PRAC recommendation dated 7 November 2013 with regard to substances related to nicotinic acid (acipimox) indicated for the treatment of lipid disorders.
Maltese: Is-CMDh ikkunsidra r-rakkomandazzjoni tal-PRAC ta' hawn taħt datata s-7 ta' Novembru 2013 firrigward ta' sustanzi relatati ma' aċidu nikotiniku (acipimox) indikati għall-kura ta' disturbi fil-lipidi.
English: • The PRAC considered that acipimox is efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia) but only, on the basis of available evidence including current medical knowledge on the use of acipimox, as a second or third line agent in patients who have not responded adequately to other treatments such as statin or fibrate treatment;
Maltese: • Il-PRAC ikkunsidra li acipimox huwa effikaċi fit-tnaqqis tal-livelli tat-trigliċeridi f'pazjenti b'ipertrigliċeridemija (iperlipoproteinemija tat-tip IV skont il-klassifika ta' Fredrickson) u b'iperkolesterolemija u ipertrigliċeridemija (iperlipoproteinemija tat-tip IIb skont il-klassifika ta' Fredrickson) imma biss, abbażi tal-evidenza disponibbli inkluż għarfien mediku attwali dwar l-użu ta' acipimox, bħala aġent tat-tieni jew tat-tielet linja f'pazjenti li ma jkunux irrispondew b'mod adegwat għal kura oħra bħal kura bi statin jew fibrat;
English: Based on the available data, acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
Maltese: Abbażi tad-dejta disponibbli, acipimox kien meqjus li kien effikaċi fit-tnaqqis tal-livelli tat-trigliċeridi f'pazjenti b'ipertrigliċeridemija (iperlipoproteinemija tat-tip IV skont il-klassifika ta' Fredrickson) u superjuri b'mod sinifikanti għal plaċebo f'pazjenti b'iperkolesterolemija u ipertrigliċeridemija (iperlipoproteinemija tat-tip IIb skont il-klassifika ta' Fredrickson).
English: Having reviewed all the available data, including studies and publications on acipimox as well as data on the related substance nicotinic acid, including the AIM-HIGH and HPS2-THRIVE studies, the PRAC considered the efficacy of acipimox in the treatment of certain well-defined lipid disorders to be demonstrated and that acipimox therefore remains a treatment alternative in the management of lipid disorders characterised by elevated plasma levels of triglycerides (Fredrickson type IV hyperlipoproteinaemia), or both triglycerides and cholesterol
Maltese: Wara li rreveda d-dejta kollha disponibbli, inklużi studji u pubblikazzjonijiet dwar acipimox kif ukoll dejta dwar is-sustanza relatata aċidu nikotiniku, inklużi l-istudji AIM-HIGH u HPS2-THRIVE, il-PRAC ikkunsidra li l-effikaċja ta acipimox fil-kura ta' ċerti disturbi fil-lipidi definiti sew kienet intweriet u li għalhekk acipimox jibqa' alternattiva ta' kura fil-ġestjoni ta' disturbi fil-lipidi kkaraterizzati minn żidiet fil-livelli tat-trigliċeridi fil-plasma (iperlipoproteinemija tat-tip IV skont il-klassifika ta' Fredrickson), jew kemm trigliċeridi u kolesterol (iperlipoproteinemija tat-tip IIb skont il-klassifika ta' Fredrickson).
English: The preliminary results of the HPS2-THRIVE study showed that the study did not meet its primary endpoint (reduction of the risk of major vascular events such as heart attack and stroke) as well as a statistically significant increase in the incidence of non-fatal but serious adverse events in the nicotinic acid/laropiprant group compared to the placebo group.
Maltese: Ir-riżultati preliminari tal-istudju HPS2-THRIVE urew li l-istudju ma kienx laħaq lendpoint primarju tiegħu (it-tnaqqis tar-riskju ta' avvenimenti vaskulari maġġuri bħal attakk tal-qalb u puplesija) kif ukoll żieda statistikament sinifikanti fl-inċidenza ta' avvenimenti avversi mhux fatali iżda serji fil-grupp ta' aċidu nikotiniku/laropiprant meta mqabbel mal-grupp tal-plaċebo.
English: The CMDh, having considered the PRAC recommendation pursuant to article 107k of Directive 2001/83/EC dated 7 November 2013, reached a position on the variation to the terms of the marketing authorisations of acipimox for which the relevant sections of the summary of product characteristics and package leaflets are set out in Annex III.
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC skont l-artikolu 107k tadDirettiva 2001/83/KE datata s-7 ta' Novembru 2013, laħaq pożizzjoni dwar il-varjazzjoni lit-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' acipimox li għalihom is-sezzjonijiet relevanti tassommarju tal-karatteristiċi tal-prodott u l-fuljetti ta' tagħrif huma stabbiliti fl-Anness
English: The safety data available for acipimox, including data on nicotinic acid obtained from HPS2-THRIVE, showed that the safety profile of acipimox is well characterised.
Maltese: Id-dejta dwar is-sigurtà disponibbli għal acipimox, inkluż dejta dwar aċidu nikotiniku li nkisbet minn HPS2-THRIVE, uriet li l-profil tas-sigurtà ta' acipimox huwa kkaratterizzat sew.
English: Most identified adverse events are already reflected in the acipimox product information and the PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity, which was addressed by adding a warning to the product information.
Maltese: Ħafna mill-avvenimenti avversi identifikati huma diġà riflessi fl-informazzjoni dwar il-prodott ta' acipimox u l-PRAC ikkunsidra li d-dejta disponibbli ma identifikat l-ebda informazzjoni ġdida dwar is-sigurtà li għandha impatt fuq ilbilanċ tal-benefiċċju-riskju ta' acipimox, bl-eċċezzjoni ta' riskju potenzjali ta' tossiċità fil-muskoli, li kien indirizzat permezz ta' żieda fl-informazzjoni dwar il-prodott.
English: The PRAC concluded that the benefit-risk balance of acipimox-containing products remains favourable under normal conditions of use, subject to the agreed changes to the product information.
Maltese: Il-PRAC ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' prodotti li fihom acipimox jibqa' favorevoli taħt kondizzjonijiet normali ta' użu, soġġett għat-tibdil miftiehem lill-informazzjoni dwar il-prodott.
English: The PRAC also agreed that acipimox should not be indicated for increasing HDL-C or for cardiovascular prevention in line with the recent data casting doubts on the association between elevating HDL-C levels and reducing the risk of cardiovascular disease.
Maltese: Il-PRAC qabel ukoll li acipimox m'għandux ikun indikat biex iżid l-HDL-C jew għall-prevenzjoni kardjovaskulari f'konformità ma' dejta riċenti li tefgħet dubji dwar lassoċjazzjoni bejn iż-żieda fil-livelli ta' HDL-C u t-tnaqqis tar-riskju ta' mard kardjovaskulari.
English: Having reviewed the list of EU products containing nicotinic acid or related substances, the PRAC noted that acipimox is the only high-dose substance indicated in lipid disorders still authorised in the EU and the scope of the procedure was therefore restricted to acipimox-containing products.
Maltese: Wara li rreveda l-lista talprodotti tal-UE li fihom aċidu nikotiniku jew sustanzi relatati, il-PRAC innota li acipimox huwa l-unika sustanza f'doża għolja indikata f'disturbi fil-lipidi li għadu awtorizzat fl-UE u għalhekk il-kamp ta' applikazzjoni tal-proċedura ġie ristrett għal prodotti li fihom acipimox.
English: Overall conclusion
Maltese: Konklużjoni globali
English: Sci Rep. 2016 Nov 7;6:36250
Maltese: Nov 7;6:36250
English: Proc Natl Acad Sci U S A. 2015 Jan 6;112(1):E56-64.
Maltese: Jan 6;112(1):E56-64.
English: Choi CS, Gonzales EL, Kim KC, Yang SM, Kim JW, Mabunga DF, et al.
Maltese: 2 Choi CS, Gonzales EL, Kim KC, Yang SM, Kim
English: The medicinal products will continue to be listed in the additional monitoring list.
Maltese: Il-prodotti mediċinali se jibqgħu jiġu elenkati fil-lista ta' monitoraġġ addizzjonali.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products containing substances related to valproate.
Maltese: • Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom sustanzi relatati ma' valproate.
English: This resulted in a value which was more than 25,000 times lower than the AUC in a woman treated orally with an equal dose (single oral dose 500 mg).
Maltese: Dan irriżulta f'valur li kien aktar minn 25,000 darba inqas mill-AUC f'mara kkurata oralment b'doża ugwali (doża orali waħda ta' 500 mg).
English: The PRAC adopted a recommendation on 08 February 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni, fit-8 ta' Frar 2018 li dak iż-żmien kienet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: In the previous European review (2014)3, several educational measures for patients and healthcare professionals (HCPs) were recommended.
Maltese: Fir-rieżami Ewropew preċedenti (2014)3, ġew irrakkomandati diversi miżuri edukattivi għall-pazjenti u l-professjonisti fil-qasam tal-kura tas-saħħa (HCPs).