FrancophonIA/ELRC3.0 huggingface dataset:
English: As Haldol Decanoate is an injectable long-acting depot formulation recommended to be used every 4 weeks, in order to avoid medication errors in which either haloperidol injectable or haloperidol decanoate are administered in error, the MAH has committed to conduct further post-marketing safety analysis after completion of the Art 30 referral, while assessing the need for changing the name of the medicinal product thereafter.
Maltese: Billi l-Haldol Decanoate huwa formulazzjoni ta' depot injettabbli li ddum taġixxi u li hija rrakkomandata li tintuża kull 4 ġimgħat, sabiex jiġu evitati żbalji fil-medikazzjoni fejn haloperidol injettabbli jew inkella haloperidol decanoate tiġi amministrata bi żball, il-MAH impenja ruħu li jwettaq analiżi ulterjuri tas-sikurezza wara t-tqegħid fis-suq wara t-tlestija tar-riferiment fl-Art 30, filwaqt li jivvaluta l-ħtieġa għat-tibdil tal-isem tal-prodott mediċinali wara.
English: The final indication agreed for Haldol decanoate is for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol.
Maltese: L-indikazzjoni finali miftiehma għal Haldol Decanoate hija għall-kura ta' manteniment ta' skiżofrenija u disturb skiżoaffettiv f'pazjenti adulti li bħalissa huma stabbilizzati b'haloperidol orali.
English: After intramuscular injection (IM), Haldol Decanoate is gradually released from muscle tissue and hydrolysed slowly into free haloperidol, which enters the systemic circulation.
Maltese: Wara injezzjoni intramuskulari (IM), Haldol Decanoate jiġi rilaxxat gradwalment mit-tessut tal-muskolu u jiġi idrolizzat bil-mod f'haloperidol ħielsa, li tidħol fiċ-ċirkolazzjoni sistemika.
English: Contraindications relating to children less than 3 years of age and breastfeeding women were not included due to the lack of adequate data to support such contraindications.
Maltese: Il-kontraindikazzjonijiet li jirrigwardjaw tfal ta' inqas minn 3 snin u nisa li qegħdin ireddgħu ma ġewx inklużi minħabba nnuqqas ta' data adegwata li tappoġġja dawn il-kontraindikazzjonijiet.
English: Based on the review of all available data and the consultations with the Healthcare Professionals Organisations (HCPOs), the CHMP recommended the following revision and harmonisation of the product information for Haldol Decanoate and associated names.
Maltese: Abbażi tar-rieżami tad-data kollha disponibbli u tal-konsultazzjonijiet mal-Organizzazzjonijiet ta' Professjonisti fil-Qasam tal-Kura tas-Saħħa (HCPOs), is-CHMP irrakkomanda r-reviżjoni u larmonizzazzjoni li ġejjin tal-informazzjoni dwar il-prodott għal Haldol Decanoate u l-ismijiet assoċjati.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission (EC) notified the European Medicines Agency's Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve the divergences amongst the nationally approved SmPCs and thus to harmonise its divergent SmPCs across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri fir-rigward tal-awtorizzazzjoni tal-prodott imsemmi hawn fuq (u l-ismijiet assoċjati tiegħu), il-Kummissjoni Ewropea (KE) nnotifikat lisSegretarjat tal-Aġenzija Ewropea għall-Mediċini dwar riferiment uffiċjali skont l-Artikolu 30 tadDirettiva 2001/83/KE sabiex jiġu riżolti d-diverġenzi fost l-SmPCs approvati fuq livell nazzjonali u b'hekk jiġu armonizzati l-SmPCs diverġenti tagħha madwar l-UE kollha.
English: The full EPAR for Victoza 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: Cardiovascular events occurred in 13% (608 out of 4668) of patients taking Victoza compared with 14.9% (694 out of 4672) of patients taking placebo.
Maltese: L-avvenimenti kardjovaskulari seħħew fi 13% (608 minn 4668) tal-pazjenti li jieħdu Victoza meta mqabbla ma' 14.9% (694 minn 4672) tal-pazjenti li ngħataw il-plaċebo.
English: This compared with a reduction of 0.5 percentage points with glimepiride.
Maltese: Dan huwa komparabbli ma' tnaqqis ta' 0.5 punti perċentwali bi glimepiride.
English: The triple therapies containing Victoza led to a reduction of between 1.3 and 1.5 percentage points compared with a reduction equal or less than 0.5 points without Victoza.
Maltese: It-terapiji tripli li fihom Victoza wasslu għal tnaqqis ta' bejn 1.3 u 1.5 punti perċentwali meta mqabbla ma' tnaqqis ugwali għal 0.5 punti jew inqas mingħajr Victoza.
English: The active substance in Victoza, liraglutide, is an ‘incretin mimetic'.
Maltese: Is-sustanza attiva f'Victoza, il-liraglutide, hija ‘inkretin mimetiku'.
English: Other information about Victoza
Maltese: Informazzjoni oħra dwar Victoza
English: This is a summary of the European public assessment report (EPAR) for Victoza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Victoza.
English: Results from this study show that Victoza at a dose of 1.2 mg reduced HbA1c by 0.8 percentage points, whereas Victoza at a dose of 1.8 mg led to reductions of 1.1 percentage points.
Maltese: Ir-riżultati minn dan listudju juru li Victoza f'doża ta' 1.2 mg naqqas HbA1c b'0.8 punti perċentwali, filwaqt li Victoza f'doża ta' 1.8 mg wassal għal tnaqqis ta' 1.1 punti perċentwali.
English: Patients were followed up on average for 3.8 years.
Maltese: Il-pazjenti kienu segwiti għal medja ta' 3.8 snin.
English: Victoza is used:
Maltese: Victoza jintuża:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Victoza on 30 June 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Victoza valida fl-Unjoni Ewropea kollha fit-30 ta' Ġunju 2009.
English: In one ‘monotherapy' study, Victoza on its own was compared with glimepiride (a sulphonylurea).
Maltese: Fi studju dwar ‘monoterapija', Victoza waħdu tqabbel ma' glimepiride (sulfonilurea).
English: Why is Victoza approved?
Maltese: Għal xiex ġiet approvat Victoza?
English: Adding Victoza to treatment with basal insulin plus metformin reduced HbA1c by 0.7 percentage points, compared with 0.4 points when adding Victoza to insulin aspart.
Maltese: Iż-żieda ta' Victoza ma' kura b'insulina bażali flimkien ma' metformina naqqset l-HbA1c b'0.7 punti perċentwali, meta mqabbla ma' 0.4 punti meta ġiet miżjuda doża ta' insulina Victoza.
English: Victoza is a solution for injection available in pre-filled pens (6 mg/ml).
Maltese: Victoza huwa soluzzjoni għall-injezzjoni li tiġi f'pinen mimlija lesta (6 mg/ml).
English: Victoza was effective at controlling blood glucose in six main studies involving 4,155 adults with type 2 diabetes.
Maltese: Victoza kien effettiv fil-kontroll tal-livelli tal-glukożju fid-demm f'sitt studji prinċipali li involvew 4,155 adult bid-dijabete tat-tip 2.
English: What are the risks associated with Victoza?
Maltese: X'inhuma r-riskji assoċjati ma' Victoza?
English: In two ‘triple therapy' studies, Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione) were compared with treatments that included placebo or another anti-diabetes medicine instead of Victoza.
Maltese: F'żewġ studji dwar ‘terapija tripla', Victoza mal-metformina u mal-glimepiride jew mar-rosiglitazone (tip ta' tijazolidinedjon), tqabblu flimkien ma' kuri li inkludew plaċebo jew mediċina oħra kontra ddijabete minflok Victoza.
English: Combinations containing Victoza were more effective at controlling blood glucose than combinations without the medicine.
Maltese: Kombinazzjonijiet li fihom Victoza kienu aktar effettivi fil-kontroll tal-glukożju fid-demm minn kombinazzjonijiet mingħajr il-mediċina.
English: • as an ‘add-on' to other diabetes medicines.
Maltese: • bħala 'żieda' ma' mediċini oħra tad-dijabete.
English: The study involved 9,340 patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack or stroke).
Maltese: L-istudju kien involva 9,340 pazjent bid-dijabete tat-tip 2 li diġà kellhom mard kardjovaskulari (bħal anġina, attakk tal-qalb u puplesija).
English: The starting dose of Victoza is 0.6 mg. After at least one week, the dose is increased to 1.2 mg.
Maltese: Wara tal-inqas ġimgħa, id-doża tiżdied għal 1.2 mg.
English: Dual therapies containing Victoza and metformin or glimepiride led to reductions in HbA1c of around 1 percentage point compared with no reduction without Victoza.
Maltese: Terapiji doppji li fihom Victoza u l-metformina jew il-glimepiride wasslu għal tnaqqis flHbA1c ta' madwar 1 punt perċentwali meta mqabbel mal-ebda tnaqqis mingħajr Victoza.
English: Victoza used on its own was more effective at controlling blood glucose than glimepiride.
Maltese: Victoza użat waħdu kien aktar effettiv fil-kontroll tal-glukożju fid-demm minn glimepiride.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Maltese: HbA1c tagħti indikazzjoni ta' kemm il-glukożju fid-demm huwa kkontrollat tajjeb.
English: • on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;
Maltese: • waħdu meta l-użu ta' metformina (mediċina oħra għad-dijabete tat-tip 2) ma jkunx rakkomandat;
English: How is Victoza used?
Maltese: Kif jintuża Victoza?
English: The most common side effects with Victoza (seen in more than 1 patient in 10) are nausea and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni b'Victoza (li dehru f'iktar minn pazjent 1 minn kull 10) huma nnawżja u d-dijarrea.
English: In another triple therapy study, Victoza was compared with a single dose of a short-acting insulin, insulin aspart, when added to treatment with basal insulin (a long-acting insulin) plus metformin.
Maltese: Minbarra l-istudji msemmija hawn fuq, Victoza intwera li kien effettiv fit-tnaqqis tal-effetti kardjovaskulari avversi (il-qalb u l-vażijiet).
English: It is given independent of meals and preferably at the same time each day.
Maltese: Jingħata indipendentament mill-ikliet u preferibbilment kuljum fl-istess ħin.
English: When Victoza is added to treatment with a sulphonylurea or insulin, the doctor should consider lowering the dose of the other medicine to reduce the risk of having hypoglycaemia (low blood glucose).
Maltese: tabib għandu jikkunsidra li jnaqqas id-doża tal-mediċina l-oħra sabiex inaqqas ir-riskju li sseħħ ipogliċemija (livell baxx ta' glukożju fid-demm).
English: For the full list of all side effects and restrictions with Victoza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Victoza, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Victoza?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Victoza?
English: The full EPAR for Keppra 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: With Keppra at a dose of 2,000 mg, the reduction was 27%, and with 3,000 mg, it was around 39%.
Maltese: B'doża ta' 2,000 mg ta' Keppra, it-tnaqqis kien 27%, u bi 3,000 mg, kien madwar 39%.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg), as an oral solution (100 mg/ml), and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Maltese: Keppra jiġi bħala pilloli (250 mg, 500 mg, 750 mg u 1,000 mg), bħala soluzzjoni orali (100 mg/ml), u bħala konċentrat li jsir soluzzjoni għall-infużjoni (dripp fil-vina, 100 mg/ml).
English: This summary was last updated in 07-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2013.
English: The active substance in Keppra, levetiracetam, is an anti-epileptic medicine.
Maltese: Is-sustanza attiva f'Keppra, levetiracetam, hija mediċina antiepilettika.
English: This document is a summary of the European public assessment report (EPAR) for Keppra.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Keppra.
English: • for partial onset seizures, placebo treatment reduced the weekly number of seizures by 6 to 7%, while the reduction with Keppra at a dose of 1,000 mg per day was between 18 and 33%, depending on the study.
Maltese: • għal aċċessjonijiet parzjali tal-bidu, it-trattament bil-plaċebo naqqas l-għadd ta' aċċessjonijiet ta' kull ġimgħa b'bejn 6 u 7%, filwaqt li t-tnaqqis b'Keppra b'doża ta' 1,000 mg kuljum kienet bejn 18 u 33%, skont l-istudju.
English: This can be increased up to 21 mg/kg twice a day.
Maltese: Din tista' tiżdied sa 21 mg/kg darbtejn kuljum.
English: Keppra is a medicine that contains the active substance levetiracetam.
Maltese: Keppra huwa mediċina li fiha s-sustanza attiva levetiracetam.
English: • in partial-onset seizures, it has been studied in three main studies in a total of 904 patients aged 16 years and over.
Maltese: • f'aċċessjonijiet parzjali tal-bidu, fi tliet studji ewlenin b'total ta' 904 pazjenti minn 16-il sena 'l fuq.
English: • for tonic-clonic seizures, the number of seizures fell by an average of 28% in the patients receiving placebo, compared with 57% in those receiving Keppra.
Maltese: • għal aċċessjonijiet kloniċi toniċi, in-numru ta' aċċessjonijiet naqas b'medja ta' 28% fil-pazjenti li kienu qed jirċievu l-plaċebo, apparagun mas-57% f'dawk li kienu qed jirċievu Keppra.
English: In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Maltese: F'pazjenti bejn sitt xhur u 17-il sena li jiżnu inqas minn 50 kg, iddoża tal-bidu għandha tkun 10 mg għal kull kilogramm tal-piż tal-ġisem darbtejn kuljum, li tista' tiżdied sa 30mg/kg darbtejn kuljum.
English: Keppra used on its own has been studied in 579 patients with partial-onset seizures aged 16 years and over, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years.
Maltese: Keppra użat waħdu ġie studjat f'579 pazjent b'aċċessjonijiet parzjali tal-bidu minn 16-il sena 'l fuq, li ngħataw jew Keppra jew carbamazepine (mediċina antiepilettika oħra) fuq medda ta' sentejn.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod preċiż kif taħdem il-levetiracetam għadu mhux ċar iżda jidher li din tinterferixxi ma' proteina msejħa proteina sinaptika vexxili 2A, li tinstab fl-ispazji ta' bejn in-nervituri, u għandha sehem fir-rilaxx ta' messaġġiera kimiċi miċ-ċelloli tan-nervituri.
English: • in myoclonic seizures, Keppra was studied in 122 patients aged 12 years and over, who received either Keppra or placebo in addition to their normal anti-epileptic medicine for up to 30 weeks;
Maltese: • f'aċċessjonijiet mijokloniċi, f'122 pazjent minn 12 -il sena ‘l fuq, li rċevew jew Keppra jew plaċebo flimkien mal-mediċina antiepilettika sa 30 ġimgħa;
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 have a genetic cause).
Maltese: • aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji (attakki severi, inkluż it-telf tal-kuxjenza) f'pazjenti minn 12-il sena 'l fuq li jbatu bl-epilessija ġeneralizzata idjopatika (it-tip ta' epilessija li maħsuba li għandha kawża ġenetika).
English: In these studies, Keppra at doses of 1,000, 2,000 or 3,000 mg per day, was compared with placebo (a dummy treatment) over 12 to 14 weeks.
Maltese: F'dawn l-istudji, Keppra f'dożi ta' 1,000, 2,000, jew 3,000 mg kuljum, tqabblu ma' plaċebo (trattament finta) fuq medda ta' 12 u 14-il ġimgħa.
English: • in primary generalised tonic-clonic seizures, Keppra was compared with placebo in 164 patients aged four years or over.
Maltese: • f'aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji, Keppra ġie mqabbel ma' plaċebo f'164 pazjent minn 4 snin ‘il fuq.
English: This is a type of epilepsy where too much 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 talmoħħ tikkawża sintomi bħal movimenti spażmodiċi għal għarrieda ta' xi parti mill-ġisem, smigħ, xamm, jew viżta mhux ċari, titrix jew sens ta' biża' f'daqqa.
English: Keppra has also been compared with placebo in 314 patients aged between one month and 17 years;
Maltese: Keppra ġie mqabbel ukoll ma' plaċebo f'314 pazjent taletajiet bejn xahar u 17 -il sena;
English: The most common side effects with Keppra (seen in more than 1 patient in 10) are nasopharyngitis (inflammation of the nose and throat), somnolence (sleepiness), and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Keppra (li dehru f'aktar minn pazjent 1 minn kull 10) huma nasofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma), ħedla u wġigħ ta' ras.
English: The daily dose can be increased up to 1,500 mg twice a day.
Maltese: Id-doża ta' kuljum tista' tiżdied sa 1,500 mg darbtejn kuljum.
English: • for myoclonic seizures, the number of seizure days per week was halved in 58% of the patients receiving Keppra and in 23% of the patients receiving placebo;
Maltese: • f'aċċessjonijiet mijokloniċi, in-numru ta' ġranet ta' aċċessjonijiet kull ġimgħa naqas bin-nofs f'58% tal-pazjenti li kienu qed jirċievu Keppra u fi 23% tal-pazjenti li kienu qed jirċievu l-plaċebo;
English: As an add-on treatment, Keppra was more effective than placebo:
Maltese: Bħala trattament ta' żieda, Keppra kien iktar effettiv mill-plaċebo:
English: Epilepsy is caused by excessive electrical activity in the brain.
Maltese: L-epilessija tiġi kkawżata millattività elettrika eċċessiva fil-moħħ.
English: When Keppra is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Maltese: Meta Keppra jingħata flimkien ma' trattamenti antiepilettiċi oħra, id-doża inizjali f'pazjenti minn 12-il sena 'l fuq li jiżnu iktar minn 50 kg għandha tkun ta' 500 mg darbtejn kuljum.
English: All of the patients were taking at least one other anti-epileptic medicine.
Maltese: Il-pazjenti kollha kienu qegħdin jieħda għallinqas mediċina antiepilettika oħra.
English: Why has Keppra been approved?
Maltese: Għaliex ġie approvat Keppra?
English: Keppra has also been studied as an add-on treatment:
Maltese: Keppra ġie studjat ukoll bħala trattament ta' żieda:
English: How has Keppra been studied?
Maltese: Kif ġie studjat Keppra?
English: What is Keppra?
Maltese: X'inhu Keppra?
English: Keppra must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.
Maltese: Keppra ma għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għal-levetiracetam jew għal kwalunkwe sustanza oħra misluta mill-pirrolidoniċi (mediċini bi struttura simili għal-levetiracetam), jew għal xi ingredjenti oħra tiegħu.
English: What is the risk associated with Keppra?
Maltese: X'inhu r-riskju assoċjat ma' Keppra?
English: In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Maltese: Fi trabi li għandhom bejn xahar u sitt xhur, id-doża inizjali għandha tkun 7 mg/kg darbtejn kuljum, permezz tas-soluzzjoni orali.
English: Other information about Keppra:
Maltese: Aktar tagħrif dwar Keppra:
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Maltese: • aċċessjonijiet mijokloniċi (qosra, movimenti spażmodiċi donnhom xokkijiet ta' muskolu jew ta' grupp ta' muskoli) f'pazjenti minn tnax-il sena 'l fuq li jbatu bl-epilessija mijoklonika ġuvenili;
English: The CHMP decided that Keppra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Keppra huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Maltese: Id-doża tista' tiżdied aktar f'intervalli ta' ġimagħtejn skont ir-rispons talpazjent, għal doża massima ta' 1,500 mg darbtejn kuljum.
English: When Keppra 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 Keppra jintuża waħdu, id-doża tal-bidu hija 250 mg darbtejn kuljum, u tiżdied ġimagħtejn wara għal 500 mg darbtejn kuljum.
English: Keppra 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: Keppra jista' jintuża waħdu f'pazjenti minn 16-il sena 'l fuq li ġew dijanjostikati għall-ewwel darba blepilessija, sabiex ifejjaq il-bidu parzjali ta' aċċessjoni (epilessija severa) bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizures.
Maltese: Keppra jista' jintuża wkoll bħala żieda ma' mediċini antiepilettiċi oħra biex jikkura:
English: Keppra was also more effective than placebo in children;
Maltese: Keppra kien iktar effettiv ukoll mill-plaċebo fit-tfal;
English: Keppra tablets are swallowed with liquid.
Maltese: Il-pilloli Keppra jinbelgħu mal-likwidu.
English: The full EPAR for Tasermity 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 02-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 02-2015.
English: Tasermity is available as tablets (800 mg).
Maltese: Tasermity jiġi bħala pilloli (800 mg).
English: In a study of 84 patients undergoing haemodialysis, there was an average fall in phosphate levels of 0.65 mmol/l in patients taking Tasermity for 8 weeks, compared with a fall of 0.68 mmol/l in patients taking calcium acetate, another phosphate-lowering medicine.
Maltese: Fi studju ta' 84 pazjent li kienu qegħdin jagħmlu emodijaliżi, kien hemm tnaqqis medju fil-livelli ta' fosfat ta' 0.65 mmol/l f'pazjenti li ħadu Tasermity għal 8 ġimgħat, meta mqabbel ma' tnaqqis ta' 0.68 mmol/l f'pazjenti li kienu qegħdin jieħdu aċetat tal-kalċju, mediċina oħra li tnaqqas il-fosfat.
English: Other information about Tasermity
Maltese: Informazzjoni oħra dwar Tasermity
English: Tasermity contains the active substance sevelamer hydrochloride.
Maltese: Tasermity fih is-sustanza attiva sevelamer kloridrat.
English: This is a summary of the European public assessment report (EPAR) for Tasermity.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tasermity.
English: The benefit of Tasermity has also been shown in a study of 143 patients undergoing peritoneal dialysis: patients receiving Tasermity in this study had similar falls in phosphate levels over 12 weeks as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).
Maltese: Il-benefiċċju ta' Tasermity intwera wkoll fi studju ta' 143 pazjent li kienu għaddejjin minn dijaliżi peritonali: pazjenti li rċevew Tasermity f'dan l-istudju kellhom tnaqqis simili fil-livelli ta' fosfat fuq 12il ġimgħa bħall-pazjenti li rċevew kalċju aċetat (0.52 u 0.58 mmol/l, rispettivament).
English: The active substance in Tasermity, sevelamer hydrochloride, is a phosphate binder.
Maltese: Is-sustanza attiva f'Tasermity, is-sevelamer kloridrat, teħel mal-fosfat.
English: Why is Tasermity approved?
Maltese: Għaliex ġie approvat Tasermity?