FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC concluded that ginkgo leaf medicines containing the dry extract can be used to improve the age-related cognitive impairment (worsening of mental abilities) and quality of life of adults with mild dementia.
Maltese: L-HMPC ikkonkluda li l-mediċini tal-weraq tal-ġinko li fihom l-estratt niexef jistgħu jintużaw biex itejbu indeboliment konjittiv relatat mal-età (aggravar tal-abbiltajiet mentali) u l-kwalità tal-ħajja f'adulti b'dimensja ħafifa.
English: The HMPC conclusions on the use of ginkgo leaf medicines for minor circulation problems are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini tal-werqa tal-ġinko għal problemi żgħar fiċċirkolazzjoni huma bbażati fuq l-"użu tradizzjonali" tagħhom.
English: Other information about ginkgo leaf medicines
Maltese: Aktar informazzjoni dwar il-mediċini tal-werqa tal-ġinko
English: Ginkgo leaf medicines containing these preparations are usually available in liquid and solid forms to be taken by mouth.
Maltese: Mediċini erbali tal-weraq tal-ġinko li fihom dawn il-preparazzjonijiet normalment huma disponibbli f'forom likwidi u solidi sabiex jittieħdu mill-ħalq.
English: The HMPC also concluded that, on the basis of their long-standing use, ginkgo leaf medicines containing the powdered leaf can be used for the relief of heaviness in the legs and the sensation of cold hands and feet that may occur with minor circulation problems.
Maltese: L-HMPC ikkonkluda wkoll li, abbażi tal-użu għal żmien twil tagħhom, mediċini tal-ġinko li fihom il-werqa mfarrka jistgħu jintużaw għas-serħan minn sensazzjoni ta' toqol fis-saqajn u sensazzjoni ta' idejn u saqajn kesħin li jistgħu jseħħu bi problemi zgħar fiċ-ċirkolazzjoni.
English: Although clinical studies with ginkgo leaf medicines for minor circulation problems are available, they were too limited to be used as evidence and the HMPC conclusions for this indication are based on the medicines' long-standing use.
Maltese: Għalkemm huma disponibbli studji kliniċi b'mediċini tal-weraq tal-ġinko għal problemi żgħar fiċċirkolazzjoni, kienu limitati wisq biex jintużaw bħala evidenza u l-konklużjonijiet tal-HMPC għal din lindikazzjoni huma abbażi tal-użu għal żmien twil tal-mediċini.
English: What are the risks associated with ginkgo leaf medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-werqa tal-ġinko?
English: It is available as gastroresistant capsules (blue: 20 mg; white and blue: 30 mg; orange: 40 mg; green and blue: 60 mg).
Maltese: Huwa disponibbli f'forma ta' kapsuli gastroreżistenti (blu: 20 mg; bojod u blu: 30 mg; oranġjo:
English: The IEF decreased by 52% in the Duloxetine Boehringer Ingelheim group, compared with a decrease of 33% in the placebo-treated group.
Maltese: L-IEF naqset bi 52% fil-grupp ta' Duloxetine Boehringer Ingelheim, kontra tnaqqis ta' 33% fil-grupp ittrattat bil-plaċebo.
English: Duloxetine Boehringer Ingelheim must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Maltese: Duloxetine Boehringer Ingelheim ma għandux jintuża flimkien ma' inibituri tal-monoamino ossidażi (monoamine oxidase inhibitors, grupp ta' antidepressivi), fluvoxamine (antidipressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta' antibijotiċi).
English: • moderate to severe stress urinary incontinence (SUI) in women.
Maltese: • tal-inkontinenza urinarja minn sforz (SUI - stress urinary incontinence) minn moderata għal gravi fin-nisa.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DULOXETINE BOEHRINGER INGELHEIM EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) DULOXETINE BOEHRINGER INGELHEIM Sommarju tal-EPAR għall-pubbliku
English: The active substance in Duloxetine Boehringer Ingelheim, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva fi Duloxetine Boehringer Ingelheim, duloxetine, hija inibitur tal-assorbiment millġdid tas-serotonina u tan-noradrenalina (serotonin-noradrenaline re-uptake inhibitor).
English: Duloxetine Boehringer Ingelheim is a medicine that contains the active substance duloxetine.
Maltese: Duloxetine Boehringer Ingelheim huwa mediċina li fiha s-sustanza attiva duloxetine.
English: The four main studies involved 1,913 women and lasted 12 weeks, comparing Duloxetine Boehringer Ingelheim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
Maltese: L-erba' studji prinċipali involvew 1,913-il mara u damu 12-il ġimgħa u qabblu Duloxetine Boehringer Ingelheim (l-aktar bħala doża 40 mg darbtejn kuljum) mal-plaċebo (trattament finta).
English: For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Maltese: Għat-trattament tal-uġigħ newropatiku dijabetiku, Duloxetine Boehringer Ingelheim ġie eżaminat f'żewġ studji li damu 12-il ġimgħa fuq 809 adulti dijabetiċi li ħassew uġigħ kuljum għal talanqas sitt xhur.
English: For the treatment of SUI, Duloxetine Boehringer Ingelheim has been studied in a total of 2,850 women.
Maltese: Għat-trattament ta' SUI, Duloxetine Boehringer Ingelheim ġie studjat f'total ta' 2,850 mara.
English: The European Commission granted a marketing authorisation valid throughout the EU for Duloxetine Boehringer Ingelheim to Boehringer Ingelheim International GmbH on 8 October 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Duloxetine Boehringer Ingelheim għal Boehringer Ingelheim International GmbH fit-8 ta' Ottubru 2008.
English: For SUI, the recommended dose of Duloxetine Boehringer Ingelheim is 40 mg twice a day.
Maltese: Għal SUI, id-doża rakkomandata ta' Duloxetine Boehringer Ingelheim hija 40 mg darbtejn kuljum.
English: Duloxetine Boehringer Ingelheim is used to treat:
Maltese: Duloxetine Boehringer Ingelheim jintuża għat-trattament:
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Duloxetine Boehringer Ingelheim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
Maltese: Fiż-żewġ studji, it-tnaqqis tal-uġigħ deher mill-ewwel ġimgħa ta' trattament sa perjodu massimu ta' 12-il ġimgħa u lpazjenti ttrattati b'Duloxetine Boehringer Ingelheim kellhom punteġġ ta' wġigħ bejn 1.17 u 1.45 punt anqas minn dawk il-pazjenti ttrattati bil-plaċebo.
English: It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Dan jaħdem billi jipprevjeni lin-newrotrasmettituri 5-idrossitriptamina (5-hydroxytrypamine, imsejħa wkoll serotonina) u n-noradrenalina milli jerġgħu jiġu assorbiti fiċ-ċelloli nervużi fil-moħħ u fis-sinsla tad-dahar.
English: The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients' scores on an incontinence-specific quality-of-life (I-QOL) questionnaire.
Maltese: Il-kejl ewlieni tal-effikaċja kienu l-frekwenza tal-episodji ta' inkontinenza (IEF, jiġifieri l-għadd ta' episodji ta' inkontinenza kull ġimgħa) imniżżla fuq djarju tal-pazjenti u l-punteġġ tal-pazjenti fuq il-bażi ta' kwestjonarju ta' kwalità tal-ħajja speċifiku għall-inkontinenza (I-QOL).
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Maltese: • uġigħ newropatiku periferiku dijabetiku (ħsara lin-nervituri tal-estremitajiet li tista' sseħħ f'pazjenti bid-dijabete).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Boehringer Ingelheim's benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-bniedem (CHMP) iddeċieda li l-benefiċċji ta' Duloxetine Boehringer Ingelheim huma ogħla mir-riskji tiegħu għat-trattament ta' SUI minn moderata għal gravi u tal-uġigħ newropatiku periferiku dijabetiku f'adulti.
English: For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Maltese: Għat-trattament tal-uġigħ newropatiku dijabetiku, Duloxetine Boehringer Ingelheim f'dożi ta' 60 mg darba jew darbtejn kuljum irriżulta aktar effikaċi mill-plaċebo biex inaqqas l-uġigħ.
English: For the full list of all side effects reported with Duloxetine Boehringer Ingelheim, see the Package Leaflet.
Maltese: Għal lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Duloxetine Boehringer Ingelheim, ara lFuljett ta' Tagħrif.
English: How duloxetine works in SUI is not clear but it is thought that by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Maltese: L-azzjoni ta' duloxetine fi SUI mhijiex ċara iżda jitqies li billi żżid il-livelli ta' 5-idrossitripamina e noradrenalina fil-livell tan-nervituri li jikkontrollaw il-muskolatura tal-uretra (il-kanal li jgħaqqad ilbużżieqa ma' barra), duloxetine tikkawża għeluq tal-uretra aktar bis-saħħa waqt il-bużżieqa timtela blawrina.
English: What is Duloxetine Boehringer Ingelheim?
Maltese: X'inhu Duloxetine Boehringer Ingelheim?
English: Duloxetine Boehringer Ingelheim was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Maltese: Duloxetine Boehringer Ingelheim irriżulta aktar effikaċi mill-plaċebo biss fil-pazjenti li kellhom iktar minn 14-il episodju ta' inkontinenza fil-ġimgħa (SUI minn moderata għal gravi) fil-bidu tal-istudju.
English: Combining Duloxetine Boehringer Ingelheim with pelvic floor muscle training may provide additional benefit.
Maltese: Li tgħaqqad Duloxetine Boehringer Ingelheim ma' programm ta' eżerċizzju talmuskolatura tal-qiegħ pelviku (pelvic floor) jista' jagħti aktar benefiċċju.
English: The I-QOL questionnaire scores were also improved in the Duloxetine Boehringer Ingelheim group compared with the placebo group.
Maltese: Il-punteġġi talkwestjonarju I-QOL tjiebu wkoll fil-grupp tal-pazjenti ttrattati b'Duloxetine Boehringer Ingelheim meta mqabbel mal-grupp ittrattat bil-plaċebo.
English: The most common side effects with Duloxetine Boehringer Ingelheim when used to treat SUI (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Duloxetine Boehringer Ingelheim fit-trattament ta' SUI (li dehru f'aktar minn pazjent 1 minn kull 10) huma nawżea, ħalq xott, stitikezza u għeja.
English: For diabetic neuropathic pain, the recommended dose is 60 mg once a day, but some patients may need a higher dose of 120 mg per day.
Maltese: Għall-uġigħ newropatiku dijabetiku, id-doża rakkomandata hija 60 mg darba kuljum, iżda xi pazjenti aktarx jeħtieġu doża aktar qawwija ta' 120 mg kuljum.
English: Why has Duloxetine Boehringer Ingelheim been approved?
Maltese: Għaliex ġie approvat Duloxetine Boehringer Ingelheim?
English: Other information about Duloxetine Boehringer Ingelheim:
Maltese: Aktar tagħrif dwar Duloxetine Boehringer Ingelheim:
English: The company that makes Ariclaim has agreed that its scientific data can be used for Duloxetine Boehringer Ingelheim.
Maltese: Ilkumpanija li tipproduċi Ariclaim qablet li t-tagħrif xjentifiku tagħha jista' jintuża għal Duloxetine Boehringer Ingelheim.
English: Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Maltese: Xi pazjenti jistgħu jiksbu benefiċċju minn trattament inizjali b'doża ta' 20 mg darbtejn kuljum għal ġimagħtejn qabel ma jgħaddu għad-doża rakkomandata ta' 40 mg, biex inaqqsu n-nawżea (dardir) u listurdament.
English: By closing the urethra more powerfully, Duloxetine Boehringer Ingelheim prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Maltese: Billi jagħlaq l-uretra aktar bis-saħħa, Duloxetine Boehringer Ingelheim jipprevjeni t-telf involontarju ta' awrina waqt sforz fiżiku bħas-sogħla jew id-daħk.
English: What is the risk associated with Duloxetine Boehringer Ingelheim?
Maltese: Għal xiex jintuża Duloxetine Boehringer Ingelheim?
English: 5 April 2016 EMA/823974/2015
Maltese: 5 ta' April 2016 EMA/823974/2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom instructions on how to take saw palmetto fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Common side effects (seen between 1 and 10 patients in 100) reported with saw palmetto fruit are abdominal (belly) pain and headache.
Maltese: Effetti sekondarji komuni (osservati f'pazjent 1 sa 10 minn kull 100) ġew irrapportati bil-frotta tasSerenoa huma wġigħ fl-addome (ta' żaqq) u wġigħ ta' ras.
English: Saw palmetto fruit is the common name for the fruit of the plant Serenoa repens (W. Bartram) Small.
Maltese: Frotta tas-Serenoa huwa l-isem komuni tal-frotta tal-pjanta Serenoa repens (W. Bartram) Small.
English: The way saw palmetto fruit acts is not fully known, but from laboratory studies it is thought to work by reducing the action of male sex hormones such as testosterone, which play a role in causing enlargement of the prostate gland in BPH; and it may also have anti-inflammatory effects.
Maltese: Il-mod kif taħdem il-frotta tas-Serenoa mhux magħruf bis-sħiħ, imma minn studji fil-laboratorju huwa maħsub li taħdem billi tnaqqas l-azzjoni tal-ormoni tas-sess maskili bħat-testosteron, li għandhom rwol fit-tkabbir tal-glandola tal-prostata fil-BPH; u jista' jkollha wkoll effetti antinfjammatorji.
English: The HMPC concluded that saw palmetto fruit (extracted with hexane) can be used to treat the symptoms of benign prostatic hyperplasia (BPH).
Maltese: L-HMPC ikkonkluda li l-frotta tas-Serenoa (estratta permezz tal-eżan) tista' tintuża sabiex tikkura ssintomi tat-tkabbir benin tal-prostata (BPH).
English: What are the risks associated with saw palmetto fruit medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom il-frotta tas-Serenoa?
English: In its assessment, the HMPC also considered clinical studies with saw palmetto fruit ethanol extract.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra wkoll studji kliniċi bl-estratt tal-frotta tas-Serenoa permezz tal-etanol.
English: Saw palmetto fruit
Maltese: Frotta tas-Serenoa
English: Although a possible effect in relief of lower urinary tract symptoms related to BHP was observed, there were shortcomings in the studies such as too few patients and too short a treatment period.
Maltese: Għalkemm kien osservat effett possibbli fis-serħan tas-sintomi tal-kanal saflieni tal-awrina relatati mal-BPH, kien hemm nuqqasijiet fl-istudji bħal ftit wisq pazjenti u perjodu tal-kura qasir wisq.
English: Further information on the HMPC assessment of saw palmetto fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: In its assessment, the HMPC considered a number of clinical studies with saw palmetto fruit hexane extract some of which showed that it is as effective as finasteride and tamsulosin (other medicines approved to treat BPH) at treating BPH symptoms for periods up to 1 year.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom il-frotta tas-Serenoa, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' (All Documents') fis-sit elettroniku tal-Aġenzija:
English: Saw palmetto fruit preparations may be obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (hexane or ethanol), which is then partially evaporated to obtain a soft extract.
Maltese: Il-preparazzjonijiet tal-frotta tas-Serenoa jistgħu jinkisbu bl-użu ta' teknika għall-estrazzjoni ta' komposti minn materjali tal-pjanta billi dawn jiddewbu f'solvent (eżan jew etanol), li mbagħad jiġi parzjalment evaporat biex jinkiseb estratt artab.
English: Further information on the risks associated with saw palmetto fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom il-frotta tas-Serenoa, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fis-sit elettroniku tal-Aġenzija:
English: 23 January 2015
Maltese: 23 ta' Jannar 2015
English: The full European Public Assessment Report for Teysuno 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: It is available as capsules.
Maltese: Huwa disponibbli bħala kapsuli.
English: Teysuno has been authorised in the EU since March 2011.
Maltese: Teysuno ilu awtorizzat fl-UE minn Marzu 2011.
English: Teysuno contains the active substances tegafur, gimeracil and oteracil.
Maltese: Teysuno fih is-sustanzi attivi tegafur, gimeracil u oteracil.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni inizjali pprovduta millkumpanija u fformula lista ta' mistoqsijiet.
English: The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Maltese: Is-sustanza attiva ewlenija f'Teysuno, it-tegafur, hija mediċina ċitotossika (mediċina li toqtol ċelloli li jkunu qed jiddividu, bħal ċelloli tal-kanċer) li tagħmel parti mill-grupp ta' ‘anti-metaboliti'.
English: It is used in combination with cisplatin (a platinum-based cancer medicine).
Maltese: Tintuża flimkien ma' ċisplatina (mediċina tal-kanċer abbażi tal-platinu).
English: Teysuno is a cancer medicine that is used to treat adults with advanced gastric (stomach) cancer.
Maltese: Teysuno huwa mediċina tal-kanċer li tintuża fil-kura ta' adulti b'kanċer gastriku (tal-istonku) avvanzat.
English: Tegafur is a ‘prodrug' that is converted in the body to another medicine called 5-fluorouracil (5-FU).
Maltese: Tegafur huwa ‘prodroga' li tinbidel fil-ġisem għal mediċina oħra msejħa 5-fluorouracil (5-FU). 5-FU hija simili għal pirimidina, sustanza li tinsab fil-materjal ġenetiku taċ-ċelloli (DNA jew RNA).
English: On 6 January 2015, Nordic Group BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the indication for Teysuno.
Maltese: Fis-6 ta' Jannar 2015, Nordic Group BV għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għall-awtorizzazzjoni għattqegħid fis-suq għal Teysuno.
English: The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU, and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Maltese: Iż-żewġ sustanzi attivi l-oħrajn f'Teysuno jippermettu lil tegafur sabiex ikun effettiv f'dożi iktar baxxi u b'inqas effetti sekondarji: gimeracil billi jipprevjeni t-tkissir ta' 5-FU, u oteracil billi jnaqqas l-attività ta' 5-FU f'tessut normali mhux kanċeruż fl-imsaren.
English: How is Teysuno expected to work?
Maltese: Kif huwa mistenni li jaħdem Teysuno?
English: The company presented data from two studies involving a total of 43 patients with advanced gastric cancer or other tumours, in which Teysuno was used in combination with oxaliplatin and other cancer medicines.
Maltese: Il-kumpanija ppreżentat data minn żewġ studji li involvew total ta' 43 pazjent b'kanċer gastriku avvanzat jew tumuri oħrajn, li fihom Teysuno ntuża ma' oksaliplatina u mediċini tal-kanċer oħrajn.
English: Teysuno was also expected to be used in combination with platinum-based cancer medicines other than cisplatin, such as oxaliplatin.
Maltese: Teysuno kien mistenni li jintuża wkoll flimkien ma' mediċini tal-kanċer abbażi tal-platinu apparti ċisplatina, bħal oksaliplatina.
English: The data provided were too limited to allow a benefit-risk evaluation of Teysuno in combination with other platinum-based medicines in patients with advanced gastric cancer.
Maltese: Id-data pprovduta kienet limitata wisq biex tippermetti evalwazzjoni tal-benefiċċju-riskju ta' Teysuno flimkien ma' mediċini oħrajn abbażi tal-platinu f'pazjenti b'kanċer gastriku avvanzat.
English: What was Teysuno expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża?
English: 5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA).
Maltese: Fil-ġisem, 5-FU tieħu post pirimidina u tinterferixxi mal-enzimi involuti fil-formazzjoni ta' DNA ġdid.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Teysuno could not have been approved for the treatment of advanced gastric cancer in combination with platinumbased medicines other than cisplatin.
Maltese: Fuq il-bażi tar-reviżjoni tad-data u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Teysuno ma setax jiġi approvat għall-kura ta' kanċer gastriku avvanzat flimkien ma' mediċini abbażi tal-platinu apparti ċisplatina.
English: In particular very limited data were provided on the combination of Teysuno with oxaliplatin and no data were provided on the use with carboplatin.
Maltese: B'mod partikolari, ġiet ipprovduta data limitata ħafna fuq il-kombinazzjoni ta' Teysuno ma' oksaliplatina u ebda data ma ġiet ipprovduta dwar l-użu ma' karboplatina.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the data provided were too scarce to allow adequate evaluation of the benefits and risks of Teysuno in combination with platinumbased medicines other than cisplatin in patients with advanced gastric cancer.
Maltese: Għalhekk, fiż-żmien tal-irtirar, is-CHMP kien tal-opinjoni li d-data pprovduta kienet wisq skarsa biex tippermetti evalwazzjoni adegwata tal-benefiċċji u tar-riskji ta' Teysuno flimkien ma' mediċini oħrajn abbażi tal-platinu apparti ċisplatina f'pazjenti b'kanċer gastriku avvanzat.
English: Page 6/6
Maltese: Paġna 5/5
English: Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Maltese: Qabel it-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq, l-awtoritajiet kompetenti nazzjonali, ikkoordinati mill-Istat Membru ta' referenza, għandhom jiżguraw li d-detentur talawtorizzazzjoni għat-tqegħid fis-suq jissodisfa l-kondizzjonijijiet li ġejjin: