FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi pulmonari indikattivi ta' (ILD) (eż. sogħla, deni, dispnea u/jew ipossija), u topotecan għandu jitwaqqaf jekk tiġi kkonfermata dijanjożi ġdida ta' ILD.
English: Antitumour activity was demonstrated primarily in patients with neuroblastoma.
Maltese: Attività kontra t-tumur intweriet primarjament f'pazjenti b'newroblastoma.
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Maltese: TAL-PRODOTT MEDIĊINALI Topotecan Actavis 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni topotecan
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Maltese: Flimkien ma' newtropenija severa, kien hemm inċidenza ta' deni jew infezzjoni f'16 % tal-pazjenti waqt l-ewwel kors u b'kollox f'23 % tal-pazjenti (6 % tal-korsijiet).
English: The volume of reconstituted concentrate corresponding to the calculated individual dose, should be further diluted with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion, to a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Maltese: Il-volum tal-konċentrat rikostitwit li jikkorrispondi għad-doża individwali kkalkulata, għandu jkompli jiġi dilwit jew b' soluzzjoni għall-injezzjoni klorur tas-sodju 9 mg/ml (0.9 %) jew 50 mg/ml (5 %) ,soluzzjoni tal-glukożju għall-infużjoni għal konċentrazzjoni finali ta' bejn 25 u 50 mikrogramma kull ml fis-soluzzjoni għall-infużjoni, per eżempju:
English: How to use Topotecan Actavis
Maltese: Topotecan Actavis
English: Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Maltese: Topotecan ġie ippruvat li jikkawża il-mewt jew malformazzjoni tal-embrijun jew il-fetu, fi studji prekliniċi (ara sezzjoni 5.3).
English: In clinical trials,
Maltese: Prova klinika tal-fażi
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX17.
Maltese: Aġenti antineoplastiċi oħra, kodiċi.
English: In an open-label trial involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m given as a
Maltese: Fi prova open-label li kienet tinvolvi t-tfal (n = 108, varjazzoni fl-età: trabi sa 16-il sena) b'tumuri li reġgħu feġġew jew solidi progressivi, topotecan inbeda f'doża ta' 2.0 mg/m2 mogħtija bħala infużjoni ta' 30 minuta għal 5 ijiem ripetuta kull 3 ġimgħat sa sena skond ir-rispons għat-terapija.
English: For more information about cisplatin, please refer to the corresponding package leaflet.
Maltese: Għal aktar informazzjoni dwar cisplatin, jekk jogħġbok irreferi għall-fuljett korrispondenti mal-pakkett.
English: Topotecan Actavis 1 mg vials must be reconstituted with 1.1 ml water for injections.
Maltese: Fjali ta' Topotecan Actavis ta' 1 mg iridu jiġu rikostitwiti b'1.1 ml ta' ilma għal injezzjonijiet.
English: Topotecan Actavis is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
Maltese: Topotecan Actavis mhuwiex rakkomandat fil-każ ta' problemi serji tal-fwied, - jekk għandek infjammazzjoni tal-pulmuni b'sinjali ta' sogħla, deni u diffikultajiet biex tieħu n nifs, ara wkoll is-sezzjoni 4 “Effetti sekondarji possibbli”.
English: If severe it may cause breathing difficulties.
Maltese: Jekk severa tista' tikkawża diffikultajiet respiratorji.
English: Pregnancy and breast-feeding
Maltese: Disturbi tal-metaboliżmu u n-nutrizzjoni
English: Do not use this medicine after the expiry date which is stated on the vial and carton.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li hemm fuq il-fjala u l-kartuna.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Maltese: Iridu jiġu addotati l-proċeduri normali għat-trattament u r-rimi ta' prodotti mediċinali kontra l-kanċer, speċifikament:
English: Cytotoxic
Maltese: Kanċer ċervikali
English: Initial dose The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Maltese: Id-doża rakkommandata ta' topotecan hija ta' 0.75 mg/m2/jum amministrata bħala infużjoni ġol-vina għal 30 minuta kuljum fil-jiem 1, 2 u 3. Cisplatin huwa amministrat bħala infużjoni ġol-vina fil-jum 1 f'doża ta' 50 mg/m2/jum u wara tingħata d-doża ta' topotecan.
English: The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Maltese: Ir-rata ta' rispons għal topotecan fil-programm ikkombinat tal-kanċer taċ-ċelluli ż-żgħar tal-pulmun (n = 480) għall-pazjenti fejn reġgħet feġġet il-marda li kienet sensittiva għat-terapija ewlenija, kien ta' 20.2 %.
English: Symptoms may include yellow skin (jaundice).
Maltese: Is-sintomi jafu jinkludu ġilda safra (suffejra).
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 1 mg powder for concentrate for solution for infusion topotecan
Maltese: TAL-PRODOTT MEDIĊINALI Topotecan Actavis 1 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni topotecan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 4 mg topotecan (as hydrochloride).
Maltese: Kull fjala fiha 4 mg topotecan (bħala idrokloridu).
English: Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Maltese: It-tagħrif integrat ta' sikurezza għal monoterapija b'topotecan huma ppreżentati hawn taħt.
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Maltese: In-newtropenija kkawżata minn topotecan tista' tikkawża l-kolite newtropenika.
English: Add 19 ml to give 20 ml 4 ml of 1 mg/ml topotecan solution Add 156 ml to give 160 ml Add 76 ml to give 80 ml
Maltese: Żid 156 ml biex tagħti 160 ml
English: Patients without prior cisplatin chemoradiotherapy Cisplatin
Maltese: Pazjenti li ma ħadu l-ebda Kimoradjuterapija b'Cisplatin qabel Cisplatin
English: The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95 % CI 0.78 -1.40).
Maltese: Il-proporzjon ta' periklu għassoppravivenza ta' topotecan li jingħata fil-vina meta mqabbel ma' CAV kien 1.04 (95 % CI
English: The median survival for patients treated with topotecan + BSC was 25.9 weeks (95 % C.I.
Maltese: Is-soppravivenza medjana għall-pazjenti trattati b'topotecan + BSC kienet ta' 25.
English: Актавис ЕАД Teл.
Maltese: Żomm dan il-fuljett.
English: This concentrate (1 mg/ml) must be diluted prior to administration.
Maltese: Dan il-konċentrat (1 mg/ml) għandu jiġi dilwit qabel l-amministrazzjoni.
English: Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Maltese: Il-ftit informazzjoni li teżisiti tindika li d-doża trid titnaqqas f'pazjenti li jbatu minn indeboliment moderat tal-kliewi.
English: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Maltese: L-użu ta' Topotecan għandu jkun limitat għal dipartimenti speċjalizzati fl-amministrazzjoni talkimoterapija ċitotossika u għandu jiġi amministrat biss taħt l-osservazzjoni ta' tabib li għandu esperjenza fl-użu tal- kimoterapija (ara sezzjoni 6.6).
English: • Risk Management Plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I.
Maltese: F'pazjenti (n = 39) b'rikorrenza fi żmien 180 jum wara kemoradjuterapija b'cisplatin, issoppravivenza medjana meta topotecan ingħata flimkien ma' cisplatin kienet ta' 4.6 xhur (95 % C.I.: 2.6, 6.1) versu 4.5 xhur (95 % C.I.: 2.9, 9.6) għal cisplatin bi proporzjon ta' periklu ta' 1.15 (0.59, 2.23).
English: As expected, patients with poor performance status (PS > 1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Maltese: Kif inhu mistenni, pazjenti li għandhom stat ta' saħħa ħażina (PS>1) għandhom rata ta' rispons aktar baxxa u inċidenza ogħla ta' kumplikazzjonijiet bħal deni, infezzjoni u sepsis (ara sezzjoni 4.8).
English: : 4.9, 9.5) for the cisplatin arm with a hazard ratio of 0.75 (0.49, 1.16).
Maltese: F'dawk (n = 102) b'rikorrenza wara 180 jum, is-soppravivenza medjana meta topotecan ingħata flimkien ma' cisplatin kienet ta' 9.9 xhur (95 % C.I.: 7, 12.6) versu 6.3 xhur (95 % C.I.: 4.9, 9.5) għal cisplatin bi proporzjoni ta' periklu ta' 0.75 (0.49, 1.16).
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion
Maltese: TAL-PRODOTT MEDIĊINALI Topotecan Actavis 4 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: Topotecan is contraindicated in patients who - have a history of severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - are breast-feeding (see section 4.6) - already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 10
Maltese: Topotecan huwa kontroindikat f'pazjenti li - għandhom ipersensittività qawwija għas-sustanza attiva jew kwalunkwe mill-eċċipjenti elenkati fis-sezzjoni 6.1 - ikunu qed ireddgħu (ara sezzjoni 4.6) - qabel ma bdew l-ewwel kors diġà jkollhom depressjoni qawwija tal-mudullun, kif muri mil-linja bażi ta' newtrofili ta' < 1.5 x 109/l u/jew għadd ta' plejtlits ta' ≤ 100 x 109/l.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg topotecan (as hydrochloride).
Maltese: Kull fjala fiha 1 mg topotecan (bħala idrokloridu).
English: EMA/898508/2018 EMEA/H/C/003954
Maltese: EMA/843782/2018 EMA/H/C/003954
English: Further information on Orkambi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Orkambi.
Maltese: ema.europa.eu/medicines/human/EPAR/Orkambi.
English: Other information about Orkambi
Maltese: Informazzjoni oħra dwar Orkambi
English: Orkambi (lumacaftor / ivacaftor)
Maltese: Orkambi (lumakaftor / ivakaftor)
English: Orkambi received a marketing authorisation valid throughout the EU on 19 November 2015.
Maltese: Orkambi ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Novembru 2015.
English: Overall the number of exacerbations was reduced by 39% when compared with placebo.
Maltese: B'mod ġenerali n-numru ta' aggravamenti tnaqqas b'39% meta mqabbel ma' plaċebo.
English: Orkambi contains the active substances lumacaftor and ivacaftor.
Maltese: Orkambi fih is-sustanzi attivi lumakaftor u ivakaftor.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system.
Maltese: Il-fibrożi ċistika hija marda ereditarja li għandha effetti severi fuq il-pulmun u s-sistema diġestiva.
English: Orkambi improved lung function in two main studies involving 1,108 cystic fibrosis patients aged 12 years and above, and one study involving 204 children aged from 6 to 11 years.
Maltese: Orkambi tejjeb il-funzjoni tal-pulmun f'żewġ studji ewlenin li involvew 1,108 pazjenti b'fibrożi ċistika li għandhom minn 12-il sena ‘l fuq, u fi studju ieħor li involva 204 tifel u tifla li għandhom bejn 6 snin u 11-il sena.
English: What are the risks associated with Orkambi?
Maltese: X'inhuma r-riskji assoċjati ma' Orkambi?
English: One of the active substances in Orkambi, lumacaftor, increases the amount of CFTR protein on the cell and the other, ivacaftor, increases the activity of the defective CFTR protein.
Maltese: Waħda mis-sustanzi attivi f'Orkambi, lumakaftor, iżżid l-ammont tal-proteina CFTR fuq wiċċ iċ-ċellola u l-oħra, ivakaftor, iżżid l-attività tal-proteina CFTR difettuża.
English: Orkambi is available as tablets and granules.
Maltese: Orkambi jiġi bħala pilloli u granuli.
English: A further study involved 60 children aged 2 to 5 years with cystic fibrosis who had the F508del mutation in the CFTR gene.
Maltese: Studju ieħor involva 60 tifel u tifla ta' bejn sentejn u 5 snin bil-fibrożi ċistika li kellhom il-mutazzjoni F508del fil-ġene CFTR .
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Maltese: Il-fibrożi ċistika tiġi kkawżata minn mutazzjonijiet fil-ġene CFTR.
English: Serious side effects include liver problems such as raised liver enzymes, cholestatic hepatitis (build-up of bile leading to inflammation of the liver) and hepatic encephalopathy (a brain disease caused by liver problems).
Maltese: L-effetti sekondarji serji jinkludu problemi fil-fwied bħal livelli għoljin ta' enzimi fil-fwied, epatite kolestatika (l-akkumulu ta' bili li jwassal għal infjammazzjoni tal-fwied) u enċefalopatija epatika (marda tal-moħħ ikkawżata minn problemi filfwied).
English: This gene makes the CFTR protein, which is involved in regulating the production of mucus and digestive juices.
Maltese: Dan il-ġene jipproduċi l-proteina CFTR, li hija involuta fir-regolamentazzjoni tal-produzzjoni tal-mukus u l-likwidi diġestivi.
English: Results from the first study showed that after 24 weeks of treatment patients who took Orkambi had an average improvement in FEV1 of 2.41 percentage points more than those who took placebo; this figure was 2.65 in the second study.
Maltese: Ir-riżultati mill-ewwel studju wrew li wara 24 ġimgħa ta' kura l-pazjenti li ħadu Orkambi kellhom titjib medju fl-FEV1 ta' 2.41 punti perċentwali aktar minn dawk li ħadu l-plaċebo, filwaqt li din i-ċifra kienet 2.65 fit-tieni studju.
English: How is Orkambi used?
Maltese: Orkambi?
English: As for all medicines, data on the use of Orkambi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Orkambi hija ssorveljata kontinwament.
English: After 24 weeks of treatment, LCI2.5 decreased by 1.01 in patients treated with Orkambi compared with an increase of 0.08 in patients treated with placebo.
Maltese: Wara 24 ġimgħa ta' kura, lLCI2.5 naqas b'1.01 f'pazjenti li ngħataw kura b'Orkambi meta mqabbla ma' żieda ta' 0.08 f'pazjenti kkurati bi plaċebo.
English: The most common side effects with Orkambi (which may affect more than 1 in 10 people) are dyspnoea (shortness of breath), diarrhoea and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Orkambi (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dispnea (qtugħ ta' nifs), dijarea u nawsja (tħossok ma tiflaħx).
English: All patients had the F508del mutation in the CFTR gene.
Maltese: Il-pazjenti kollha kellhom il-mutazzjoni F508del fil-ġene CFTR.
English: Orkambi is used in patients who have a genetic mutation (change) called the F508del mutation.
Maltese: Orkambi jintuża f'pazjenti li jkollhom mutazzjoni ġenetika (bidla) msejħa l-mutazzjoni F508del.
English: The company that markets Orkambi is required to conduct a 5-year study in patients with cystic fibrosis to evaluate the long-term effects of the medicine.
Maltese: Il-kumpanija li tqiegħed Orkambi fis-suq hija meħtieġa li twettaq studju ta' 5 snin f'pazjenti b'fibrożi ċistika sabiex jiġu evalwati l-effetti fit-tul tal-mediċina.
English: Orkambi has been shown to improve lung function and lung ventilation in patients with cystic fibrosis from 6 years of age.
Maltese: Orkambi ntwera li jtejjeb il-funzjoni tal-pulmun u l-ventilazzjoni tal-pulmun f'pazjenti b'fibrożi ċistika minn 6 snin ‘il fuq.
English: In the study in children aged 6 to 11 years, the main measure of effectiveness was a decrease in the lung clearance index (LCI2.5), which indicates an improvement in lung ventilation.
Maltese: Fl-istudju fi tfal ta' bejn is-6 snin u l-11-il sena, il-kejl ewlieni tal-effikaċja kien tnaqqis fl-indiċi tattneħħija mill-pulmun (LCI2.5), li jindika titjib fil-ventilazzjoni tal-pulmun.
English: Treatment with Orkambi also reduced the number of exacerbations (flares-up) requiring hospital admission or antibiotic therapy.
Maltese: Il-kura b'Orkambi naqqset ukoll in-numru ta' aggravamenti (taħrix) li kienu jeħtieġu kura fi sptar jew terapija antibijotika.
English: However, as cystic fibrosis caused by F508del mutation is particularly severe, the observed effects were considered clinically relevant for patients with no other option.
Maltese: Madankollu, peress li fibrożi ċistika kkawżata millmutazzjoni F508del hija partikolarment severa, l-effetti osservati ġew ikkunsidrati klinikament rilevanti għal pazjenti mingħajr ebda għażla alternattiva oħra.
English: Orkambi's side effects mainly affected the gut and breathing and were generally considered mild to moderate and manageable.
Maltese: L-effetti sekondarji ta' Orkambi prinċipalment affettwaw il-musrana u t-teħid tan-nifs u ġeneralment tqiesu bħala ħfief għal moderati u maniġġabbli.
English: This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR) which is involved in regulating the production of mucus and digestive juices.
Maltese: Din ilmutazzjoni taffettwa l-ġene għal proteina li tissejjaħ regolatur tal-konduttanza transmembranja talfibrożi ċistika (CFTR) li għandha x'taqsam mar-regolamentazzjoni tal-produzzjoni tal-mukus u l-likwidi diġestivi.
English: How does Orkambi work?
Maltese: Kif jintuża Orkambi?
English: Side effects reported with Orkambi are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Orkambi huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The effects of Orkambi in children aged 2 to 5 years were considered to be similar to those in older children and a long-term study will be carried out to confirm this.
Maltese: L-effetti ta' Orkambi fi tfal li għandhom bejn sentejn u 5snin kienu kkunsidrati li huma simili għal dawk fi tfal akbar fl-età u se jitwettaq studju fit-tul biex dan jiġi kkonfermat.
English: In cystic fibrosis, the secretions become thick and cause blockage.
Maltese: Fil-fibrożi ċistika, is-sekrezzjonijiet jagħqdu u jikkawżaw imblokk.
English: There was improvement in CFTR protein activity as measured by a decrease in the amount of chloride in sweat after 24 weeks of treatment.
Maltese: Kien hemm titjib fl-attività tal-proteina tas-CFTR kif imkejla minn tnaqqis fl-ammont ta' klorur fl-għaraq wara 24 ġimgħa ta' kura.
English: A further long-term study in children aged 2 to 5 years with cystic fibrosis is also required to compare those who have the F508del mutation in the CFTR gene and are treated with Orkambi with those who have not been treated with Orkambi.
Maltese: Jinħtieġ ukoll studju ieħor fit-tul fit-tfal ta' bejn sentejn u 5 snin b'fibrożi ċistika biex jitqabblu dawk li għandhom il-mutazzjoni F508del fil-ġene CFTR u huma kkurati b'Orkambi ma' dawk li ma ġewx ikkurati b'Orkambi.
English: The beneficial effects of Orkambi were smaller than expected for a medicine that treats the mechanism of the disease rather than its symptoms.
Maltese: L-effetti ta' benefiċċju ta' Orkambi kienu inqas minn dawk mistennija għal mediċina li tikkura lmekkaniżmu tal-mard minflok is-sintomi tiegħu.
English: Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above.
Maltese: Id-doża rakkomandata tiddependi mill-età u l-piż tal-pazjent.
English: 22 March 2013 EMA/402540/2013
Maltese: 22 ta' Marzu 2013 EMA/402540/2013
English: Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Maltese: Ikkuntattja lill-uffiċjali tal-stampa tagħna Monika Benstetter jew Martin Harvey Allchurch
English: • Tredaptive, Pelzont and Trevaclyn contain two active substances: nicotinic acid (1,000 mg) and laropiprant (20 mg).
Maltese: • Tredaptive, Pelzont u Trevaclyn fihom żewġ sustanzi attivi: aċidu nikotiniku (1,000 mg) u laropiprant (20 mg).
English: Patients were followed for a median of 3.9 years.
Maltese: Il-pazjenti kienu segwiti għal perjodu medjan ta' 3.9 snin.
English: Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg to achieve a total cholesterol level of less than 3.5 mmol/l, and were then randomised to nicotinic acid / laropiprant or placebo.
Maltese: Il-pazjenti ngħataw kura b'simvastatin 40 mg jew simvastatin 40 mg flimkien ma' ezetimibe 10 mg biex jinkiseb livell totali ta' kolesterol ta' anqas minn 3.5 mmol/l, u mbagħad kienu randomizzati għal aċidu nikotiniku / laropiprant jew plaċebo.
English: • The review of Tredaptive, Pelzont and Trevaclyn was initiated at the request of the European Commission on 19 December 2012, under Article 20 of Regulation (EC) No 726/2004 following the procedural steps laid out in Article 107j and 107k of Directive 2001/83/EC.
Maltese: • Ir-reviżjoni ta' Tredaptive, Pelzont u Trevaclyn inbdiet fuq talba tal-Kummissjoni Ewropea fid19 ta' Diċembru 2012, skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 wara li segwiet ilpassi proċedurali stabbiliti fl-Artikolu 107j u 107k tad-Direttiva 2001/83/KE.
English: • The HPS2-THRIVE study was a large, long-term study involving 25,673 patients considered to be at high risk for cardiovascular events due to a history of occlusive vascular disease.
Maltese: • L-istudju HPS2-THRIVE kien studju kbir, fit-tul li fih ħadu sehem 25,673 pazjent meqjusa li kienu f'riskju għoli ta' avvenimenti kardjovaskulari minħabba storja ta' mard vaskulari okklużiv.
English: • The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 22 March 2013.
Maltese: • L-opinjoni tas-CHMP ġiet mgħoddija lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti fit-22 ta' Marzu 2013.
English: Of those enrolled, 14,741 were from Europe and 10,932 were from China.
Maltese: Minn dawk li ħadu sehem, 14,741 kienu mill-Ewropa u 10,932 kienu miċ-Ċina.
English: • An increase in the incidence of non-fatal but serious adverse events was seen.
Maltese: • Dehret żieda fl-inċidenza ta' avvenimenti avversi mhux fatali imma serji.
English: More information on the HPS2-THRIVE study is available below.
Maltese: Aktar informazzjoni dwar l-istudju HPS2-THRIVE hija disponibbli hawn taħt.
English: The medicine has been marketed under one of these trade names by Merck Sharp & Dohme Ltd in all EU Member States, except Bulgaria, France and Romania.
Maltese: Il-mediċina tqiegħdet fis-suq taħt wieħed minn dawn l-ismijiet kummerċjali minn Merck Sharp & Dohme Ltd fl-Istati Membri kollha tal-UE, ħlief fil-Bulgarija, Franza u r-Rumanija.
English: • The two active substances, nicotinic acid and laropiprant, have different functions.
Maltese: • Iż-żewġ sustanzi attivi, l-aċidu nikotiniku u laropiprant, għandhom funzjonijiet differenti.
English: The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available.
Maltese: Ir-reviżjoni ta' Tredaptive, Pelzont u Trevaclyn inbdiet f'Diċembru 2012 wara li saret disponibbli dejta ġdida minn studju kbir, fit-tul imsejjaħ HPS2-THRIVE.
English: • Tredaptive, Pelzont and Trevaclyn are identical medicines used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
Maltese: • Tredaptive, Pelzont u Trevaclyn huma mediċini identiċi li jintużaw fil-kura ta' adulti b'dislipidemija (livelli abnormalment għoljin ta' xaħam fid-demm bħal trigliċeridi u kolesterol).