FrancophonIA/ELRC3.0 huggingface dataset:
English: Pifeltro contains the active substance doravirine.
Maltese: Pifeltro fih is-sustanza attiva doravirina.
English: Other information about Pifeltro
Maltese: Informazzjoni oħra dwar Pifeltro
English: Pifeltro is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Pifeltro huwa mediċina antivirali li tintuża fil-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: In a second study with 728 patients, 84% of patients treated with Pifeltro in combination with tenofovir disoproxil and lamivudine had undetectable HIV levels by 48 weeks compared with 80% of patients given a combination of efavirenz, tenofovir disoproxil and emtricitabine.
Maltese: Fit-tieni studju fuq 728 pazjent, 84 % tal-pazjenti kkurati b'Pifeltro b'kombinazzjoni ma' tenofovir disoproksil u lamivudina kellhom livelli mhux rilevabbli ta' HIV sat-48 ġimgħa meta mqabbla ma' 80 % tal-pazjenti mogħtija kombinazzjoni ta' efavirenz, tenofovir disoproksil u emtriċitabina.
English: Pifeltro is used together with other antiviral medicines.
Maltese: Pifeltro jintuża flimkien ma' mediċini antivirali oħra.
English: In a study of 766 patients, 83% of patients taking Pifeltro (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine) had undetectable levels of HIV in their blood (fewer than 40 copies/ml) after 48 weeks of treatment.
Maltese: Fi studju fuq 766 pazjent, 83 % tal-pazjenti li ħadu Pifeltro (flimkien ma' emtriċitabina u tenofovir disoproksil jew abakavir u lamivudina) kellhom livelli mhux rilevabbli ta' HIV fid-demm tagħhom (inqas minn 40 kopji/ml) wara 48 ġimgħa ta' kura.
English: Pifeltro (doravirine) EMA/821744/2018
Maltese: EMA/661893/2018
English: The active substance in Pifeltro, doravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Maltese: Is-sustanza attiva f'Pifeltro, id-doravirina, hija inibitur mhux nukleosidiku tat-traskriptażi inversa (NNRTI).
English: This compares with 79% of patients taking standard combination of darunavir plus ritonavir (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine).
Maltese: Dan jitqabbel ma' 79 % tal-pazjenti li ħadu kombinazzjoni standard ta' darunavir u ritonavir (flimkien ma' emtriċitabina u tenofovir disoproksil jew abakavir u lamivudina).
English: What are the risks associated with Pifeltro?
Maltese: X'inhuma r-riskji assoċjati ma' Pifeltro?
English: Pifeltro is available as tablets (100 mg) and can only be obtained with a prescription.
Maltese: Pifeltro jiġi bħala pilloli (100 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Pifeltro used in combination with other antivirals is as effective as standard HIV combination treatments at keeping HIV infection under control.
Maltese: Pifeltro użat b'kombinazzjoni ma' antivirali oħra huwa effettiv daqs kuri ta' kombinazzjoni standard talHIV biex iżomm l-infezzjoni tal-HIV taħt kontroll.
English: Studies showed that Pifeltro taken with other antivirals was as effective at keeping HIV infection under control as standard HIV combination treatments.
Maltese: Studji wrew li Pifeltro meħud ma' antivirali oħra kien effettiv biex iżomm l-infezzjoni tal-HIV taħt kontroll daqs kuri ta' kombinazzjoni standard tal-HIV.
English: As for all medicines, data on the use of Pifeltro are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Pifeltro hija ssorveljata kontinwament.
English: The medicine is not suitable for patients who are infected with HIV that is resistant to medicines in the same class as Pifeltro (non-nucleoside reverse transcriptase inhibitors or NNRTIs).
Maltese: Il-mediċina mhijiex adattata għal pazjenti li huma infettati b'HIV reżistenti għal mediċini fl-istess klassi bħal Pifeltro (inibituri mhux nukleosidiċi tat-traskriptażi inversa jew NNRTIs).
English: Why is Pifeltro authorised in the EU?
Maltese: Għaliex Pifeltro huwa awtorizzat fl-UE?
English: Side effects reported with Pifeltro are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Pifeltro huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Doravirine blocks the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Maltese: Id-doravirina timblokka l-attività tat-traskriptażi inversa, enzima li tħalli lill-HIV jipproduċi lilu nnifsu fiċ-ċelluli li jkun infetta.
English: How is Pifeltro used?
Maltese: Kif jintuża Pifeltro?
English: What measures are being taken to ensure the safe and effective use of Pifeltro?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Pifeltro?
English: For the full list of side effects and restrictions with Pifeltro, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji u r-restrizzjonijiet kollha b'Pifeltro, ara l-fuljett ta' tagħrif.
English: What benefits of Pifeltro have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Pifeltro li ħarġu mill-istudji?
English: 1ml (200 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Maltese: 1ml (200 mg/ml) 12 (3 x 4) -il pinna mimlija għal-lest
English: The full EPAR for Avastin 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: Ovarian, fallopian tube and peritoneal cancer
Maltese: Kanċer tal-ovarji, tat-tubu fallopjan u peritoneali
English: • advanced or metastatic kidney cancer, in combination with interferon alfa-2a;
Maltese: • kanċer avvanzat jew metastatiku tal-kliewi, flimkien ma' interferon alfa-2a;
English: This is a summary of the European public assessment report (EPAR) for Avastin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Avastin.
English: Avastin contains the active substance bevacizumab.
Maltese: Avastin fih is-sustanza attiva bevacizumab.
English: The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Maltese: L-effetti sekondarji l-iktar serji huma perforazzjoni gastrointestinali (toqba fil-musrana), emorraġija (fsada) u tromboemboliżmu arterjali (koagulazzjoni fl-arterji).
English: Why has Avastin been approved?
Maltese: Għaliex ġie approvat Avastin?
English: Other information about Avastin
Maltese: Informazzjoni oħra dwar Avastin
English: In the second study, overall survival in patients given Avastin in combination with carboplatin and paclitaxel was 42.6 months, compared with 37.3 months in patients treated with carboplatin and paclitaxel only.
Maltese: Fit-tieni studju, is-sopravivenza globali f' pazjenti li ngħataw Avastin flimkien ma' karboplatin u paklitaksel kienet 42.6 xhur, meta mqabbla ma' 37.3 xhur f' pazjenti kkurati b' karboplatin u paklitaksel waħdu.
English: • Recurrent disease: three studies with Avastin in recurrent ovarian, fallopian tube and peritoneal cancers were performed in a total of 1,518 patients.
Maltese: • Marda rikorrenti: saru tliet studji b' Avastin f' kanċers tal-ovarji, tat-tubu fallopjan u peritoneali rikorrenti f' total ta' 1,518-il pazjent.
English: The third study involved 829 patients who had failed previous treatment including a fluoropyrimidine and irinotecan.
Maltese: It-tielet studju involva 829 pazjent li ma kinitx ħadmitilhom il-kura preċedenti li kien fiha fluoropyrimidine u irinotecan.
English: • Newly diagnosed disease (including advanced disease, first-line treatment): in newly diagnosed ovarian, fallopian tube and peritoneal cancer, Avastin, in combination with carboplatin and paclitaxel, has been shown to increase progression-free survival in two main studies involving 3,401 patients: the average progression-free survival was 19.3 months in patients adding Avastin versus 16.9 months with carboplatin and paclitaxel alone in one study, and 14.7 months versus 10.6 months in the second study.
Maltese: • Marda li tkun għadha kif ġiet dijanjostikata (inkluż marda avvanzata, kura tal-ewwel linja): f' kanċer tal-ovarji, tat-tubu fallopjan u peritoneali li jkun għadu kif ġie dijanjostikat, intwera li Avastin, flimkien ma' karboplatin u paklitaksel, iżid is-sopravivenza mingħajr progressjoni f' żewġ studji ewlenin li involvew 3,401 pazjent: is-sopravivenza mingħajr progressjoni kienet 19.3 xhur f' pazjenti li żiedu Avastin kontra 16.9 xhur b' karboplatin u paklitaksel waħdu fi studju wieħed, u 14.7 xhur kontra 10.6 xhur fit-tieni studju.
English: Cancer of the colon or rectum
Maltese: Kanċer tal-kolon jew tar-rektum
English: In advanced or metastatic kidney cancer, Avastin plus interferon alfa-2a has been shown to increase progression-free survival in one study in 649 patients: the average progression-free survival was 10.2 months in the patients receiving Avastin plus interferon alfa-2a and 5.4 months in those receiving interferon alfa-2a.
Maltese: Fil-kanċer tal-kliewi avvanzat jew metastatiku, intwera li Avastin flimkien ma' interferon alfa-2a jżid is-sopravivenza mingħajr progressjoni fi studju wieħed f'649 pazjent: is-sopravivenza medja mingħajr progressjoni kienet 10.2 xhur fil-pazjenti li kienu qed jirċievu Avastin flimkien ma' interferon alfa-2a u 5.4 xhur f' dawk li kienu qed jirċievu interferon alfa-2a.
English: Results showed that the average overall survival was 16.8 months with chemotherapy including Avastin compared with 12.9 months on chemotherapy alone.
Maltese: Ir-riżultati wrew li s-sopravivenza globali medja kienet 16.8 xhur bil-kimoterapija li inkludiet Avastin meta mqabbla ma' 12.9 xhur bil-kimoterapija weħidha.
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Maltese: Is-sustanza attiva f' Avastin, il-bevacizumab, hija antikorp monoklonali (tip ta'' proteina), li tfassal sabiex jirrikonoxxi u jeħel mal-fattur ta' tkabbir endoteljali vaskulari (VEGF, vascular endothelial growth factor), proteina li tiċċirkola fid-demm u tkabbar il-vażi.
English: In the second study (1,237 patients), when Avastin was added to capecitabine, the average progression-free survival was 8.6 months, compared with 5.7 months in those receiving capecitabine with placebo.
Maltese: (1,237 pazjent) meta Avastin żdied ma' kapeċitabina, is-sopravivenza mingħajr progressjoni medja kienet 8.6 xhur, meta mqabbla ma' 5.7 xhur f' dawk li rċevew kapeċitabine mal-plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Avastin on 12 January 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Avastin fit-12 ta' Jannar 2005.
English: In metastatic cancer of the colon or rectum, Avastin used with chemotherapy including a fluoropyrimidine has been shown to increase overall and progression-free survival in three main studies.
Maltese: Fil-kanċer metastatiku tal-kolon jew tar-rektum, meta Avastin intuża mal-kimoterapija inkluż fluoropyrimidine, wera li jżid is-sopravivenza globali u mingħajr progressjoni fi tliet studji ewlenin.
English: The first two studies involved patients whose metastatic disease was being treated for the first time (‘first-line' treatment): in the first study (923 patients),the average overall survival was 20.3 months in patients adding Avastin and 15.6 months in those receiving chemotherapy alone; in the second study in 1,401 patients, progression-free survival was 9.4 months in patients adding Avastin and 8.0 months in those receiving chemotherapy alone.
Maltese: Lewwel żewġ studji involvew pazjenti li l-marda metastatika tagħhom kienet qed tiġi kkurata għallewwel darba (kura tal-'ewwel linja'): fl-ewwel studju (923 pazjent), is-sopravivenza globali medja kienet 20.3 xhur f' pazjenti li żiedu Avastin u 15.6 xhur f' dawk li rċevew il-kimoterapija waħidha; fittieni studju f' 1,401 pazjenti, is-sopravivenza mingħajr progressjoni kienet 9.4 xhur f' pazjenti li żiedu Avastin u 8.0 xhur f' dawk li rċevew il-kimoterapija waħidha.
English: In the third study in patients with more aggressive cancer, progression-free survival was 6.7 months when Avastin was added to paclitaxel, topotecan, or pegylated liposomal doxorubicin, compared with 3.4 months when these chemotherapies were used on their own.
Maltese: Fit-tielet studju f' pazjenti b' kanċer aktar aggressiv, is-sopravivenza mingħajr progressjoni kienet ta' 6.7 xhur meta Avastin żdied ma' paklitaksel, topotecan, jew pegylated liposomal doxorubicin, meta mqabbla ma' 3.4 xhur meta dawn il-kimoterapiji ntużaw waħidhom.
English: In the first study (722 patients), progression-free survival was 11.4 months in patients receiving Avastin with paclitaxel, compared with 5.8 months in those receiving paclitaxel alone.
Maltese: Fl-ewwel studju (722 pazjent) is-sopravivenza mingħajr progressjoni kienet 11.4 xhur f' pazjenti li rċevew Avastin ma' paklitaksel u 5.8 xhur f'dawk li rċevew paklitaksel waħdu.
English: • In advanced, metastatic or recurrent lung cancer, Avastin plus platinum-based chemotherapy has been shown to increase overall survival in one study in 878 patients: the average overall survival was 12.3 months in the patients taking Avastin with platinum-based chemotherapy, and 10.3 months for those taking chemotherapy alone.
Maltese: • Fil-kanċer tal-pulmun avvanzat metastatiku jew rikorrenti, intwera li Avastin flimkien malkimoterapija bbażata fuq il-platinu jżid is-sopravivenza globali fi studju wieħed fi 878 pazjent: issopravivenza globali medja kienet 12.3 xhur fil-pazjenti li kienu qed jieħdu Avastin ma' kimoterapija bbażata fuq il-platinu, u 10.3 xhur għal dawk li kienu qed jieħdu l-kimoterapija waħidha.
English: • epithelial cancer of the ovary, cancer of the fallopian tube (that connect the ovaries to the womb) or the peritoneum (the membrane lining the abdomen).
Maltese: • kanċer epiteljali tal-ovarji, kanċer tat-tubu fallopjan (li jgħaqqad l-ovarji mal-utru) jew talperitonjum (ir-rita tal-membrana tal-addome).
English: • In patients with a certain subtype of non-small cell lung cancer with activating mutations in the EGFR gene, Avastin plus erlotinib has been shown to increase progression-free survival in one study in 152 patients: patients on Avastin plus erlotinib had progression-free survival of 16.0 months on average compared with 9.7 months in patients given erlotinib alone.
Maltese: • F' pazjenti b' ċertu sottotip ta' kanċer tal-pulmun mhux b' ċelloli żgħar b' mutazzjonijiet li jattivaw fil-ġene EGFR, intwera li Avastin flimkien ma' erlotinib jżid is-sopravivenza mingħajr progressjoni fi studju wieħed f' 152 pazjent: il-pazjenti fuq Avastin flimkien ma' erlotinib, bħala medja, kellhom sopravivenza mingħajr progressjoni ta' 16.0 xhur meta mqabbla ma' 9.7 xhur f' pazjenti li ngħataw erlotinib waħdu.
English: Avastin is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Maltese: Avastin jiġi bħala konċentrat li huwa magħmul minn soluzzjoni għall-infużjoni (dripp) ġo vina.
English: • cancer of the cervix (the neck of the womb) that is persistent, recurrent or metastatic.
Maltese: • kanċer taċ-ċerviċi (l-għonq tal-utru) li hu persistenti, rikorrenti jew metastatiku.
English: The most common side effects with Avastin are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Maltese: L-effetti sekondarji l-aktar komuni b' Avastin huma ipertensjoni (pressjoni tad-demm għolja), għeja jew astenija (dgħufija), dijarea u uġigħ addominali (fiż-żaqq).
English: Overall survival was 12.9 months in patients adding Avastin and 10.8 months in those receiving chemotherapy alone.
Maltese: Is-sopravivenza globali kienet 12.9 xhur f' pazjenti li żiedu Avastin u 10.
English: In cancer of the cervix, Avastin has been shown to increase overall survival in one main study involving 452 patients with advanced persistent, recurrent or metastatic cancer of the cervix.
Maltese: Fil-kanċer taċ-ċerviċi, intwera li Avastin jżid is-sopravivenza globali fi studju ewlieni wieħed li involva 452 pazjent b' kanċer taċ-ċerviċi avvanzat persistenti, rikorrenti jew metastatiku.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated.
Maltese: Id-doża hija bejn 5 u 15-il mg kull kilogramma tal-piż tal-ġisem kull ġimagħtejn jew tliet ġimgħat, skont it-tip ta' kanċer li jkun qed jiġi kkurat.
English: • cancer of the colon (large intestine) or rectum that is metastatic (has spread to other parts of the body), in combination with chemotherapy medicines that include a ‘fluoropyrimidine';
Maltese: • kanċer tal-kolon (il-musrana l-ħoxna) jew tar-rektum li huwa metastatiku (li jkun infirex ma' partijiet oħra tal-ġisem), flimkien ma' mediċini ta' kimoterapija li jinkludu 'fluoropyrimidine';
English: Avastin is given in combination with paclitaxel and either the platinum-based medicine cisplatin or, if this cannot be used, another chemotherapy medicine, topotecan.
Maltese: Avastin jingħata flimkien mal-paklitaksel u jew il-mediċina ċisplatia bbażata fuq il-platinu jew, jekk dan ma jkunx jista' jintuża, mediċina ta' kimoterapija oħra, it-topotekan.
English: In the first study, average progression-free survival was 12.4 months when Avastin was added to carboplatin and gemcitabine, compared with 8.4 months when placebo was added.
Maltese: Fl-ewwel studju, is-sopravivenza mingħajr progressjoni medja kienet 12.4 xhur meta Avastin żdied ma' karboplatin u gemcitabine, meta mqabbla ma' 8.4 xhur meta żdied il-plaċebo.
English: Avastin is a cancer medicine used to treat adults with the following types of cancer, in combination with other cancer medicines:
Maltese: Avastin huwa mediċina kontra l-kanċer li jintuża biex jikkura adulti bit-tipi ta' kanċer li ġejjin, flimkien ma' mediċini oħra kontra l-kanċer:
English: The first two studies included patients whose cancer came back 6 months or more after previous treatment (‘platinum-sensitive disease'), while the third study was in patients with more aggressive cancer that had come back within 6 months of previous treatment (‘platinum-resistant disease').
Maltese: L-ewwel żewġ studji inkludew pazjenti li l-kanċer tagħhom reġa' ħareġ wara 6 xhur jew aktar mill-kura preċedenti ('marda sensittiva għall-platinu'), filwaqt li t-tielet studju kien f' pazjenti b' kanċer aktar aggressiv li reġa' ħareġ fi żmien 6 xhur mill-kura preċedenti ('marda reżistenti għall-platinu').
English: • metastatic breast cancer, in combination with paclitaxel or capecitabine;
Maltese: • kanċer tas-sider metastatiku, fejn jintuża flimkien ma' paklitaksel jew kapeċitabina;
English: Several studies have shown that Avastin is effective at treating the types of cancers for which it is approved.
Maltese: Diversi studji wrew li Avastin huwa effettiv biex jikkura t-tipi ta' kanċers li ġie approvat għalihom.
English: The full EPAR for Talmanco 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: Talmanco is a ‘generic medicine'.
Maltese: Talmanco huwa "mediċina ġenerika".
English: Talmanco is available as 20 mg tablets.
Maltese: Talmanco jiġi bħala pilloli ta' 20 mg.
English: Talmanco contains the active substance tadalafil.
Maltese: Talmanco fih is-sustanza attiva tadalafil.
English: The active substance in Talmanco, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Maltese: Issustanza attiva f'Talmanco, it-tadalafil, tappartjeni lil grupp ta' mediċini msejħa “inibituri talfosfodjesterażi tat-tip 5 (PDE5)”, jiġifieri li jfisser li jimblokka l-enzima PDE5.
English: This is a summary of the European public assessment report (EPAR) for Talmanco.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Talmanco.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Generics on 9 January 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Talmanco valida fl-Unjoni Ewropea kollha fid-9 ta' Jannar 2017.
English: Other information about Talmanco
Maltese: Informazzjoni oħra dwar Talmanco
English: Talmanco is used in patients with class-II (slight limitation of physical activity) or class-III (marked limitation of physical activity) PAH.
Maltese: Talmanco jintuża fuq pazjenti b'PAH tal-klassi II (limitazzjoni parzjali fl-attività fiżika) jew tal-klassi III (limitazzjoni notevoli fl-attività fiżika).
English: Previously known as Tadalafil Generics.
Maltese: Preċedentement magħruf bħala Tadalafil Generics.
English: Talmanco tadalafil
Maltese: Talmanco0F
English: The recommended dose is two tablets (40 mg) once a day.
Maltese: Id-doża rakkomandata hija ta' żewġ pilloli (40 mg) darba kuljum.
English: What are the benefits and risks of Talmanco?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Talmanco?
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Adcirca, and do not need to be repeated for Talmanco.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Adcirca, u ma għandhomx għalfejn jiġu ripetuti għal Talmanco.
English: Because Talmanco 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: Peress li Talmanco 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: Talmanco is a medicine used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Maltese: Talmanco jintuża għall-kura ta' adulti b'ipertensjoni arterjali pulmonari (PAH) sabiex titjieb il-kapaċità tal-eżerċizzju fiżiku (il-kapaċità li wieħed jagħmel attività fiżika).
English: Why is Talmanco approved?
Maltese: Għaliex ġie approva Talmanco?
English: How has Talmanco been studied?
Maltese: Kif ġie studjat Talmanco?
English: The name of the medicine was changed to Talmanco on 1 March
Maltese: L-isem tal-mediċina nbidel għal Talmanco fl-1 ta' Marzu 2017.
English: When the enzyme is blocked, a substance called ‘cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes widening of the blood vessels.
Maltese: Meta l-enzima tiġi mblukkata, sustanza msejħa ‘gwanożina monofosfat ċikliku' (cGMP) ma tistax titkisser u tibqa' fil-vażi tad-demm fejn tikkawża t-twessigħ fil-vażi taddemm.
English: In patients with PAH, this lowers the blood pressure in the lungs and improves symptoms.
Maltese: F'pazjenti b'PAH, dan inaqqas il-pressjoni tad-demm fil-pulmuni u jtejjeb is-sintomi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Talmanco has been shown to have comparable quality and to be bioequivalent to Adcirca.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Talmanco wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Adcirca.
English: The Committee recommended that Talmanco be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Talmanco jkun approvat għall-użu fl-UE.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija għamlet studji li wrew li hija 'bijoekwivalenti' għall-mediċina ta' referenza.