FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding its safety, the most frequent side effects reported with Relvar Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
Maltese: Fir-rigward tas-sigurtà tiegħu, l-effetti sekondarji rrappurtati l-aktar ta' spiss b'Relvar Ellipta kienu simili għal dawk li dehru b'kuri oħrajn għas-COPD u għall-ażma; ġiet osservata żieda fl-inċidenza ta' pulmonite f'pazjenti bis-COPD.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/679015/2015 EMEA/H/C/003914
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 ta' Ottubru 2015
English: What is VeraSeal?
Maltese: X'inhu VeraSeal?
English: On 29 September 2015, Instituto Grifols S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for marketing authorisation of VeraSeal, which was intended to help stop bleeding during vascular (blood vessel) surgery when standard surgical methods for controlling bleeding are insufficient.
Maltese: Fid-29 ta' Settembru 2015, Instituto Grifols S.A. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għallawtorizzazzjoni għat-tqegħid fis-suq għal VeraSeal, li kien maħsub biex jgħin iwaqqaf il-fsada waqt kirurġija vaskulari (il-vini) meta metodi kirurġiċi standard għall-kontroll tal-fsada ma jkunux biżżejjed.
English: The applicant presented data from one main study involving 167 patients who underwent vascular surgery.
Maltese: L-applikant ippreżenta data minn studju ewlieni wieħed li sar fuq 167 pazjent li kienet saritilhom kirurġija vaskulari.
English: The main measure of effectiveness was the ability to stop bleeding during a 10-minute observation period, after applying the method to stop the bleeding.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-kapaċità li titwaqqaf il-fsada matul perjodu ta' osservazzjoni ta' 10 minuti, wara l-applikazzjoni tal-metodu għat-twaqqif tal-fsada.
English: applying manual pressure (a standard way of stopping bleeding during surgery).
Maltese: VeraSeal jew bl-applikazzjoni ta' pressjoni manwali (mod standard kif titwaqqaf il-fsada waqt ilkirurġija).
English: VeraSeal is a medicine that contains the active substances human fibrinogen and human thrombin.
Maltese: VeraSeal huwa mediċina li fiha s-sustanzi attivi fibrinoġena tal-bniedem u trombina tal-bniedem.
English: VeraSeal was expected to be used to help stop bleeding during vascular surgery when standard surgical methods for controlling bleeding are insufficient.
Maltese: VeraSeal kien mistenni li jintuża biex jgħin iwaqqaf il-fsada waqt kirurġija vaskulari meta metodi kirurġiċi standard għall-kontroll tal-fsada ma jkunux biżżejjed.
English: What was VeraSeal expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża VeraSeal?
English: When applied to a moist surface, the thrombin is activated and cuts fibrinogen up into smaller units called fibrin.
Maltese: Meta jiġi applikat fuq wiċċ niedi, it-trombina tiġi attivata u taqta' l-fibrinoġena f'biċċiet iżgħar li jissejħu fibrina.
English: The active substances in VeraSeal, human fibrinogen and human thrombin, are natural proteins in the blood and are obtained from blood donors.
Maltese: Is-sustanzi attivi f'VeraSeal, il-fibrinoġena tal-bniedem u t-trombina tal-bniedem, huma proteini naturali fid-demm u jinkisbu mid-donaturi tad-demm.
English: In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to not being able to gather the additional data required by the CHMP, including data from three ongoing clinical studies with the product, within the available timeframe.
Maltese: Fl-ittra tagħha li tgħarraf lill-Aġenzija bl-irtirar tal-applikazzjonijiet, il-kumpanija ddikjarat li l-irtirar kien minħabba li ma setgħux jiġbru data addizzjonali meħtieġa mis-CHMP, inkluża data minn tliet studji kliniċi li għadhom għaddejjin bil-prodott, fil perjodu taż-żmien disponibbli.
English: It was to be available as two separate solutions that are mixed together to prepare a sealant that is applied to the surface of blood vessels.
Maltese: Kellha tkun disponibbli bħala żewġ soluzzjonijiet separati li jitħalltu flimkien biex tiġi ppreparata sustanza siġillanti li tiġi applikata fuq wiċċ il-vini.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had concerns and was of the provisional opinion that VeraSeal could not have been approved to help stop bleeding during vascular surgery.
Maltese: Fuq il-bażi tar-reviżjoni tad-data u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li VeraSeal ma setax jiġi approvat biex jgħin iwaqqaf il-fsada matul kirurġija vaskulari.
English: What was the recommendation of the CHMP at that time?
Maltese: Kif huwa mistenni li jaħdem VeraSeal?
English: This summary was last updated in 05-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 05-2008.
English: Other information about Pelzont:
Maltese: Informazzjoni oħra dwar Pelzont:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PELZONT EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) PELZONT Sommarju ta' l-EPAR għall-pubbliku
English: The second study showed that the LDL cholesterol levels were further reduced when Pelzont was taken with simvastatin (48% reduction), compared with Pelzont alone (17% reduction) or simvastatin alone (37% reduction).
Maltese: It-tieni studju wera li l-livelli ta' kolesterol LDL tnaqqsu iktar meta Pelzont ittieħed flimkien mas-simvastatina (tnaqqis ta' 48%), milli meta Pelzont ittieħed waħdu (tnaqqis ta' 17%) jew mas-simvastatina waħedha (tnaqqis ta' 37%).
English: The first study compared the effectiveness of Pelzont with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Maltese: Lewwel studju qabbel l-effikaċja ta' Pelzont ma' dik ta' l-aċidu nikotiniku jew tal-plaċebo (trattament finta) fit-tnaqqis tal-livelli ta' kolesterol LDL f'total ta' 1,613-il pazjent.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pelzont to Merck Sharp & Dohme Ltd. on 3 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea, għal Pelzont lil Merck Sharp & Dohme Ltd. fl-14 ta' Lulju 2008.
English: In the first study, LDL cholesterol levels were reduced by 19% in patients taking Pelzont, compared with 1% in those taking placebo.
Maltese: Fl-ewwel studju, il-livelli ta' kolesterol LDL tnaqqsu bi 19% fil-pazjenti li kienu qed jieħdu Pelzont, meta mqabbla ma' 1% f'dawk li kienu qed jieħdu l-plaċebo.
English: The two active substances in Pelzont, nicotinic acid and laropiprant, have different modes of action.
Maltese: Iż-żewġ sustanzi attivi f'Pelzont, aċidu nikotiniku u laropiprant, għandhom modi differenti ta' azzjoni.
English: The second study compared the combination of Pelzont and simvastatin (a statin) with Pelzont alone or simvastatin alone in 1,398 patients.
Maltese: It-tieni studju qabbel il-kombinazzjoni ta' Pelzont u simvastatina (statina) ma' Pelzont waħdu jew simvastatina waħedha f'1,398 pazjent.
English: Primary means that the hypercholesterolaemia does not have any identifiable cause.
Maltese: Primajru tfisser li l-iperkolesterolemija ma jkollhiex kawża identifikabbli.
English: Why has Pelzont been approved?
Maltese: Għaliex ġie approvat Pelzont?
English: Pelzont is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Maltese: Pelzont huwa mediċina li fiha żewġ sustanzi attivi: aċidu nikotiniku (magħruf ukoll bħala nijaċina [niacin] jew vitamina
English: Patients with combined mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Maltese: Il-pazjenti b'dislipidemja kombinata mħallta jkollhom livelli għoljin ta' kolesterol LDL 'ħażin' u ta' trigliċeridi (tip ta' xaħam), u livelli baxxi ta' kolesterol 'tajjeb' HDL fiddemm.
English: Pelzont was effective in reducing the blood levels of LDL cholesterol.
Maltese: Pelzont irriżulta effikaċi fit-tnaqqis tal-livelli ta' kolesterol LDL fid-demm.
English: It is available as modified-release tablets.
Maltese: Huwa disponibbli bħala pilloli b'rilaxx modifikat.
English: They included a total of 2,349 patients who were taking either Pelzont or nicotinic acid.
Maltese: F'dawn b'kollox ħadu sehem 2,349 pazjent li kienu qegħdin jieħdu Pelzont jew aċidu nikotiniku.
English: How has Pelzont been studied?
Maltese: Kif ġie studjat Pelzont?
English: What is Pelzont?
Maltese: X'inhu Pelzont?
English: Nicotinic acid is a naturally occurring substance that is used in low doses as a vitamin.
Maltese: L-aċidu nikotiniku huwa sustanza naturali li tintuża f'dożi baxxi bħala vitamina.
English: Pelzont is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Maltese: Pelzont jintuża flimkien mad-dieta u l-eżerċizzju fiżiku f'pazjenti b'dislipidemija (livelli għoljin b'mod anomalu ta' xaħam fid-demm), b'mod partikolari 'dislipidemija kombinata mħallta' u 'iperkolesterolemija primarja'.
English: Flushing due to nicotinic acid is thought to occur because of the release of a substance called ‘prostaglandin D2' (PGD2) from cells in the skin, which dilates (widens) the blood vessels in the skin.
Maltese: Huwa maħsub li l-ħmura fil-wiċċ minħabba l-aċidu nikotiniku sseħħ minħabba r-rilaxx ta' sustanza magħrufa bħala 'prostaglandina D2' (PGD2) minn ċelluli fil-ġilda, li twessa' l-arterji u l-vini fil-ġilda.
English: Pelzont is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Maltese: Pelzont normalment jingħata flimkien ma' statina (statin, il-mediċina standard użata għat-tnaqqis talkolesterol) meta l-effikaċja ta' l-istatina meħuda waħedha ma jkunx biżżejjed.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Pelzont's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Pelzont huma ogħla mir-riskji tiegħu għat-trattament tad-dislipidemija, b'mod partikolari f'pazjenti b'dislipidemija kombinata mħallta u f'pazjenti b'iperkolesterolemija primarja.
English: It should also not be used in patients who have problems with their liver, an active stomach ulcer or bleeding from an artery.
Maltese: Lanqas ma għandu jintuża f'pazjenti bi problemi filfwied, b'ulċera attiva fl-istonku jew bi fsada minn arterja.
English: Adding laropiprant to nicotinic acid reduced the symptoms of flushing caused by nicotinic acid.
Maltese: Iż-żieda ta' laropiprant ma' l-aċidu nikotoniku naqset is-sintomi tal-ħmura fil-wiċċ ikkawżata millaċidu nikotiniku.
English: What is the risk associated with Pelzont?
Maltese: X'inhu r-riskju assoċjat ma' Pelzont?
English: The effects of Pelzont were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Pelzont għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Pelzont was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Maltese: Pelzont ġie studjat f'erba' studji ewlenin b'iperkolesterolemija jew b'dislipidemja mħallta.
English: may be given to adults or children from 3 years of age and weighing at least 15 kg.
Maltese: Darunavir Krka d.d. jista' jingħata lill-adulti u lit-tfal minn 3 snin 'il fuq u li jiżnu millinqas 15-il kg.
English: The active substance in Darunavir Krka d.d., darunavir, is a protease inhibitor.
Maltese: Is-sustanza attiva f'Darunavir Krka d.d., darunavir, hija inibitur tal-proteażi.
English: can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Darunavir Krka d.d. jista' jinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Darunavir Krka d.d. huwa mediċina antivirali li tintuża f'kombinazzjoni ma' mediċini oħra tal-HIV filkura ta' pazjenti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża ssindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka d.d.
Maltese: Diġà saru l-istudji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Prezista, u m'hemmx għalfejn jiġu ripetuti għal Darunavir Krka d.d.
English: The full EPAR for Darunavir Krka d.d.
Maltese: Kif jintuża Darunavir Krka d.d.?
English: It is given with low-dose ritonavir or, in adults, with cobicistat.
Maltese: Jingħata ma' ritonavir b'doża baxxa jew, fl-adulti, ma' cobicistat.
English: The medicine is to be taken with low-dose ritonavir or, as an alternative in adults, with cobicistat and with other HIV medicines, and should be taken with food.
Maltese: Din il-mediċina għandha tittieħed ma' doża baxxa ta' ritonavir jew, bħala alternattiva fl-adulti, ma' cobicistat u ma' mediċini oħra tal-HIV, u għandha tittieħed mal-ikel.
English: For more information on generic medicines, see the questionand-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsijiet u tweġibiet hawnhekk.
English: is always given with ritonavir.
Maltese: Darunavir Krka d.d. jingħata dejjem flimkien ma' ritonavir.
English: is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Darunavir Krka d.d. huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What are the benefits and risks of Darunavir Krka d.d.
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Darunavir Krka d.d.?
English: This is a summary of the European public assessment report (EPAR) for Darunavir Krka d.d.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Darunavir Krka d.d. Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tagħha fl-UE u lkondizzjonijiet ta' użu tagħha.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body.
Maltese: Meta l-enzima tiġi mblokkata, il-virus ma jirriproduċix ruħu b'mod normali, u jittardja r-rata ta' multiplikazzjoni fil-ġisem.
English: Spain
Maltese: Applikant
English: DIDANOSINA AUROBINDO 250mg cápsulas duras gastrorresistente s
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, applicant fl-Istati Membri
English: Didanosina Aurobindo
Maltese: Mnjen jingħata
English: Didanosina Aurobindo 250mg capsule rigide gastroresistenti
Maltese: Qawwa Għamla Farmaċewtika
English: United Kingdom
Maltese: Stat Membru EU/EEA
English: Further information on Verzenios 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: Verzenios is available as tablets (50 mg, 100 mg and 150 mg).
Maltese: Verzenios jiġi bħala pilloli (50 mg, 100 mg u 150 mg).
English: Verzenios contains the active substance abemaciclib.
Maltese: Verzenios fih is-sustanza attiva abemaciclib.
English: Other information about Verzenios
Maltese: Informazzjoni oħra dwar Verzenios
English: The most common side effects with Verzenios (which may affect more than 1 in 10 people) are diarrhoea, infections, neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), tiredness, nausea (feeling sick), vomiting and decreased appetite.
Maltese: L-effetti sekondarji l-aktar komuni b'Verzenios (li jistgħu jaffetwaw aktar minn persuna 1 minn kull 10) huma dijarea, infezzjonijiet, newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), anemija (għadd baxx taċ-ċelloli ħomor tad-demm), għeja, nawsja (tħossok ma tiflaħx), rimettar u tnaqqis fl-aptit.
English: The recommended dose is 150 mg twice a day.
Maltese: Id-doża rakkomandata hija ta' 150 mg darbtejn kuljum.
English: The dose should be reduced if the patient is also taking certain medicines called ‘CYP3A4 inhibitors'.
Maltese: Id-doża għandha titnaqqas jekk il-pazjent ikun qiegħed jieħu wkoll ċerti mediċini msejħa “inibituri ta' CYP3A4”.
English: What are the risks associated with Verzenios?
Maltese: X'inhuma r-riskji assoċjati ma' Verzenios?
English: As for all medicines, data on the use of Verzenios are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Verzenios hija ssorveljata kontinwament.
English: How is Verzenios used?
Maltese: Verzenios?
English: The active substance in Verzenios, abemaciclib, blocks the activity of enzymes known as cyclindependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide.
Maltese: Is-sustanza attiva f'Verzenios, l-abemaciclib, timblokka l-attività ta' enzimi magħrufa bħala kinażijiet li jiddependu miċ-ċiklina (CDK) 4 u 6, li għandhom rwol ewlieni biex jirregolaw il-mod ta' kif iċ-ċelloli jikbru u jinqasmu.
English: In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably.
Maltese: F'xi kanċers, inkluż il-kanċer tas-sider pożittiv għall-HR, l-attività ta' CDK 4 u 6 tiżdied, u dan jgħin biex iċ-ċelloli tal-kanċer jimmultiplikaw bla kontroll.
English: How does Verzenios work?
Maltese: Kif jaħdem Verzenios?
English: By blocking CDK4 and CDK6, Verzenios slows the growth of HR-positive breast cancer cells.
Maltese: Billi jimblokka CDK4 u CDK6, Verzenios inaqqas it-tkabbir taċ-ċelloli tal-kanċer tas-sider pożittiv għall-HR.
English: It is used together with a hormonal medicine, either an aromatase inhibitor or fulvestrant.
Maltese: Dan jintuża flimkien ma' mediċina ormonali, jew inibitur tal-aromatażi jew fulvestrant.
English: For the full list of side effects and restrictions of Verzenios, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Verzenios, ara l-fuljett ta' tagħrif.
English: In the second study women taking Verzenios and fulvestrant lived on average 16 months without their disease getting worse, compared with 9 months for women taking placebo and fulvestrant.
Maltese: Fit-tieni studju, in-nisa li kienu qegħdin jieħdu Verzenios u fulvestrant għexu medja ta' 16-il xahar mingħajr ma ggravat il-marda tagħhom; meta mqabbel ma' 9 xhur għan-nisa li kienu qegħdin jieħdu plaċebo u fulvestrant.
English: Regarding safety, the main risk is diarrhoea, which is considered manageable with dose reduction.
Maltese: Fir-rigward tas-sigurtà, ir-riskju ewlieni huwa dijarea, li titqies li tista' tiġi mmaniġġjata bi tnaqqis fiddoża.
English: Verzenios used with an aromatase inhibitor or fulvestrant increased the time it took for the disease to get worse in postmenopausal women with HR-positive and HER2-negative breast cancer that is advanced or metastatic.
Maltese: Verzenios jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda u tiġi sorveljata minn tabib b'esperjenza fl-użu ta' mediċini tal-kanċer.
English: Two main studies, involving 1,162 women, mostly postmenopausal, with HR-positive, HER2-negative breast cancer that had started to spread, showed that Verzenios can prolong the time patients live without their disease getting worse (progression-free survival).
Maltese: Żewġ studji ewlenin, li involvew 1,162 mara, li ħafna minnhom għaddew mill-menopawża, b'kanċer tas-sider pożittiv għall-HR, negattiv għall-HER2 li kien beda jinfirex, urew li Verzenios jista' jtawwal iżżmien li jgħixu l-pazjenti mingħajr ma tiggrava l-marda tagħhom (sopravivenza mingħajr progressjoni).
English: In the first study women taking Verzenios and an aromatase inhibitor (letrozole or anastrozole) lived on average 28 months without their disease getting worse compared with 15 months for women taking placebo (a dummy treatment) and an aromatase inhibitor.
Maltese: Fl-ewwel studju, in-nisa li kienu qegħdin jieħdu Verzenios u inibitur tal-aromatażi (letrozole jew anastrozole) għexu medja ta' 28 xahar mingħajr ma ggravat il-marda tagħhom meta mqabbel ma' 15il xahar għan-nisa li kienu qegħdin jieħdu plaċebo (kura finta) u inibitur tal-aromatażi.
English: In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
Maltese: F'nisa li għadhom ma waslux sal-menopawża, għandha tingħata wkoll mediċina msejħa agonista ta' ormon luteinizzanti li tirrilaxxa l-ormoni.
English: Verzenios can only be used when the cancer cells have certain types of receptor (called hormone receptors) on their surface (HR-positive) and do not produce abnormally large quantities of another receptor called HER2 (HER2-negative).
Maltese: Verzenios jista' jintuża biss meta ċ-ċelloli talkanċer ikollhom ċerti tipi ta' riċetturi (imsejħa riċetturi tal-ormon) fuq il-wiċċ tagħhom (pożittiv għallHR) u ma jipproduċux kwantitajiet kbar b'mod anormali ta' riċettur ieħor imsejjaħ HER2 (negattiv għall-HER2).
English: A third study, conducted in 132 women who had received previous cancer treatment, failed to demonstrate that Verzenios used on its own was of benefit in the treatment of HR-positive, HER2negative breast cancer that had started to spread.
Maltese: It-tielet studju, li sar f'132 mara li kienu rċivew kura preċedenti għall-kanċer, naqas milli juri li Verzenios użat waħdu kien ta' benefiċċju fil-kura tal-kanċer tas-sider pożittiv għall-HR, negattiv għallHER2 li kien beda jinfirex.
English: Grapefruit juice should be avoided during treatment with Verzenios as it may affect the way the medicine is absorbed and broken down in the body.
Maltese: Il-meraq tal-grejpfrut għandu jiġi evitat waqt il-kura b'Verzenios peress li dan jista' jaffettwa l-mod ta' kif il-mediċina tiġi assorbita u mkissra fil-ġisem.
English: Ref.: EMEA/350155/2009 EMEA/H/C/1015
Maltese: EMEA/350155/2009 EMEA/H/C/1015
English: The injections were given 21 days apart.
Maltese: L-injezzjonijiet ingħataw f'intervalli ta' 21 jum.
English: At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Maltese: Fil-21 jum wara t-tieni injezzjoni, 84 % tal-persuni li rċevew il-vaċċin kellhom livelli ta' antikorpi li jistgħu jipproteġuhom kontra l-H5N1.
English: The resulting ‘emulsion' is then injected.
Maltese: L-‘emulsjoni' riżultanti imbagħad tiġi injettata.
English: This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Maltese: Dan huwa tip ta' vaċċin speċjali intiż sabiex jipproteġi kontra razza ta' influenza li tista' tikkawża pandemija fil-futur.