FrancophonIA/ELRC3.0 huggingface dataset:
English: The additional studies showed that Prevenar 13 led to an increase in antibody production following booster vaccinations and supported a switch to Prevenar 13 in children who had started vaccination with Prevenar.
Maltese: L-istudji addizzjonali wrew li Prevenar 13 ikkaġuna żieda fil-produzzjoni ta' antikorpi wara t-tilqim buster u ppermetta l-qlib għal Prevenar 13 fi tfal li kienu bdew jitlaqqmu bi Prevenar.
English: The fourth study in adults over 65 years of age showed that Prevenar 13 reduced the incidence of pneumonia by almost half: 49 out of 42,240 (around 0.1%) subjects fell ill with pneumonia caused by
Maltese: Ir-raba' studju f'adulti ta' ‘l fuq minn 65 sena wera li Prevenar 13 naqqas l-inċidenza ta' pulmonite bi kważi nofs: 49 minn 42,240 (madwar 0.1%) suġġett mardu bil-pulmonite kkawżata minn S. pneumoniae fil-grupp tal-vaċċin, meta mqabbel ma' 90 minn 42,256 (madwar 0.2%) individwu filgrupp tal-plaċebo.
English: In adults aged 50 and older, in the first two main studies Prevenar 13 produced an immune response that was at least as good as the 23-valent polysaccharide vaccine for all 12 of the S. pneumoniae polysaccharides they share in common, and for several of these serotypes the immune response was better with Prevenar 13.
Maltese: F'adulti minn 50 sena 'l fuq, fl-ewwel żewġ studji prinċipali, Prevenar 13 kellu rispons immunitarju li kien mill-inqas tajjeb daqs il-vaċċin 23-valent polisakkaridi għat-12-il polisakkaridi S. pneumoniae kollha li għandhom komuni, u għal diversi minn dawn is-sirotipi r-rispons immunitarju kien aħjar bi Prevenar 13.
English: The second study involved 938 adults aged 70 years or older who had already been vaccinated against invasive disease caused by S. pneumoniae at least five years earlier.
Maltese: It-tieni studju involva 938 adult ta' 70 sena jew akbar li kienu diġà tlaqqmu mill-inqas ħames snin qabel kontra mard invażiv ikkawżat minn S. pneumoniae.
English: A third study, which involved 900 adults aged 18 to 49, compared the immune response to Prevenar 13 with the response in adults aged 60 to 64.
Maltese: It-tielet studju, li involva 900 adult ta' bejn it-18 u d-49 sena, qabbel ir-rispons immunitarju ta' Prevenar 13 mar-rispons taladulti f'etajiet li jvarjaw bejn is-60 u l-64 sena.
English: Prevenar 13 was compared with Prevenar.
Maltese: Prevanar 13 tqabbel ma' Prevenar.
English: For the prevention of pneumonia, although the use of Prevenar 13 was only investigated in adults over 65 years of age, the CHMP considered that the results could also be applied to younger adults as studies have shown that their immune response is similar or higher than that among adults older than 65.
Maltese: Għall-prevenzjoni ta' pulmonite, għalkemm l-użu ta' Prevenar 13 ġie biss investigat f'adulti ta' ‘l fuq minn 65 sena, is-CHMP ikkunsidra li r-riżultati jistgħu jiġu applikati wkoll għal adulti iżgħar peress li studji wrew li r-rispons immunitarju tagħhom huwa simili jew ogħla minn dak fost adulti ikbar minn 65 sena.
English: The vaccine is also ‘adsorbed' (fixed) onto an aluminium compound to enhance the immune response.
Maltese: Il-vaċċin jiġi wkoll “assorbit” (imwaħħal) f'kompost tal-aluminju biex jistimula r-rispons immunitarju.
English: In Europe, it is estimated that these are responsible for between 73 and 100% of the cases of invasive disease in children under the age of five years, and at least 50 - 76% of the cases of invasive disease in adults, depending on the country.
Maltese: Fl-Ewropa, huwa stmat li dawn huma responsabbli għal bejn 73 u 100% tal-każijiet kollha ta' mard invażiv fi tfal taħt il-ħames snin, u mill-inqas 50 - 76% tal-każijiet ta' mard invażiv f'adulti, skont il-pajjiż.
English: In adults and the elderly, the Committee noted that community-acquired pneumonia and invasive pneumococcal disease may be an important health problem and that the benefit in terms of protection outweighed the risk of adverse reactions.
Maltese: Fl-adulti u l-anzjani, il-Kumitat innota li pulmonite miksuba mill-komunità u mard pnewmokokkali invażiv jistgħu jkunu problemi ta' saħħa importanti u li l-benefiċċju fir-rigward tal-protezzjoni kien akbar mir-riskju ta' reazzjonijiet avversi.
English: Adults aged 18 to 49 had an immune response with Prevenar 13 which was as good as the response in adults aged 60 to 64.
Maltese: L-adulti ta' bejn it-18 u d-49 sena kellhom rispons immunitarju bi Prevenar 13 li kien tajjeb daqs ir-rispons f'adulti ta' bejn is-60 u l-64 sena.
English: The CHMP noted that in children the immune system's response to Prevenar 13 was comparable to that of Prevenar, which is already authorised for the protection of children against S. pneumoniae in the EU.
Maltese: Is-CHMP innota li fit-tfal ir-rispons tas-sistema immunitarja għal Prevenar 13 kien komparabbli ma' dak ta' Prevenar, li huwa diġà awtorizzat għallprotezzjoni tat-tfal kontra s-S. pneumoniae fl-UE.
English: The most common side effects with Prevenar 13 (seen in more than 1 patient in 10) in children are decreased appetite, fever (only very common in children aged 6 weeks to 5 years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor quality sleep.
Maltese: L-effetti sekondarji l-aktar komuni bi Prevenar 13 (li dehru f'iktar minn pazjent 1 minn kull 10) fit-tfal kienu tnaqqis fl-aptit, deni (komuni ħafna biss fit-tfal ta' bejn 6 ġimgħa u 5 snin), irritabbiltà,
English: All six of the additional polysaccharides in Prevenar 13 produced a response that was similar to the response seen with Prevenar against the seven polysaccharides.
Maltese: Is-sitt polisakkaridi addizzjonali kollha fi Prevenar 13 kellhom rispons li kien simili għal dak li deher bi Prevaner kontra sseba' polisakkaridi.
English: What is the risk associated with Prevenar 13?
Maltese: X'inhu r-riskju assoċjat ma' Prevenar 13?
English: In adults, Prevenar 13 was investigated in four main studies.
Maltese: Fl-adulti, Prevenar 13 ġie studjat f'erba' studji ewlenin.
English: How has Prevenar 13 been studied?
Maltese: Kif ġie studjat Prevenar 13?
English: The fourth dose, the booster, is given between 11 and 15 months of age.
Maltese: Ir-raba' doża, il-buster, tingħata meta t-tfal ikollhom bejn 11 u 15-il xahar.
English: What is Prevenar 13?
Maltese: Għal xiex jintuża Prevenar 13?
English: Further information on the use of Prevenar 13 in people at increased risk of pneumococcal infections (such as patients with HIV or people who have received a haematopoietic stem cell transplant) and on how to switch from Prevenar to Prevenar 13 can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Aktar tagħrif dwar l-użu ta' Prevenar 13 f'nies b'riskju miżjud ta' infezzjonijiet pnewmokokkali (bħal pazjenti b'HIV jew nies li rċevew trapjant taċ-ċelloli staminali ematopojetiċi) u fuq kif taqleb minn Prevenar għal Prevenar 13 jinsab fis-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Prevenar 13 must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients or to diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Maltese: Prevenar 13 ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi, għal kwalunkwe sustanza oħra tiegħu jew għat-tossojde difterika (tossina mdgħajfa mill-batterju li jikkawża d-difterite).
English: Prevenar 13 can be used in children who have started vaccination with Prevenar (another vaccine authorised in the European Union for S. pneumoniae, which contains parts of seven of the 13 types of S. pneumoniae included in Prevenar 13).
Maltese: Prevenar 13 jista' jintuża fi tfal li bdew jitlaqqmu bi Prevenar (vaċċin ieħor awtorizzat fl-Unjoni Ewropea għal S. pneumoniae, li fih partijiet minn seba' mit-13-il tip ta' S. pneumoniae li jinsabu fi Prevenar 13).
English: It is also used to protect adults and the elderly against invasive disease and pneumonia caused by S. pneumoniae.
Maltese: Jintuża wkoll biex jipproteġi lill-adulti u lill-anzjani minn mard invażiv u minn pulmonite kkawżati minn S. pneumoniae.
English: Why has Prevenar 13 been approved?
Maltese: Għaliex ġie approvat Prevenar 13?
English: • children between two and 17 years of age should receive a single dose.
Maltese: • tfal ta' bejn sentejn u 17-il sena għandhom jingħataw doża waħda.
English: Invasive disease occurs when the bacterium spreads through the body causing serious infections such as septicaemia (blood infection) and meningitis (infection of the membranes around the brain and spine).
Maltese: Mard invażiv iseħħ meta l-batterju jinfirex mal-ġisem kollu, u jikkawża infezzjonijiet serji bħal settiċemija (infezzjoni fid-demm) u meninġite (infezzjoni fil-membrani madwar il-moħħ u l-ispina).
English: A risk management plan has been developed to ensure that Prevenar 13 is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Prevenar 13 jintuża bl-aktar mod sigur possibbli.
English: Adults and children aged two years and above should receive one single dose of Prevenar 13 into the shoulder muscle.
Maltese: Adulti u tfal mill-età ta' sentejn ‘il fuq għandhom jingħataw doża waħda ta' Prevenar 13 fil-muskolu talispalla.
English: In children aged between five and 17 years old, Prevenar 13 produced a response that was at least as good as Prevenar for all seven S. pneumoniae polysaccharides they share in common.
Maltese: Fi tfal fl-etajiet ta' bejn ħamsa u 17-il sena, Prevenar 13 kellu rispons li kien għall-inqas tajjeb daqs Prevenar għas-seba' polisakkaridi S. pneumoniae kollha li għandhom inkomuni.
English: Additional studies in children looked at the effects of giving booster vaccinations, switching from Prevenar to Prevenar 13 and using Prevenar 13 alongside other vaccines routinely given to children.
Maltese: Studji ulterjuri fit-tfal stħarrġu l-effetti tal-għoti tat-tilqim buster, bil-qlib minn Prevenar għal Prevenar 13 u bl-użu ta' Prevenar 13 flimkien ma' vaċċini oħra li jingħataw lit-tfal b'rutina.
English: The studies compared the immune response for Prevenar 13 with that for Prevenar against the seven polysaccharides that they share in common.
Maltese: L-istudji qabblu r-rispons immunitarju għal Prevenar 13 ma' dak għal Prevenar kontra s-seba' polisakkaridi li għandhom inkomuni.
English: How is Prevenar 13 used?
Maltese: X'inhu Prevenar 13?
English: The immune response to the additional six polysaccharides in Prevenar 13 was compared with the lowest immune response to any of the polysaccharides in Prevenar.
Maltese: Ir-rispons immunitarju għas-sitt polisakkaridi addizzjonali fi Prevenar 13 tqabbel marrispons immunitarju l-aktar baxx ta' kwalunkwe wieħed mill-polisakkaridi fi Prevenar.
English: The full EPAR for Docetaxel Mylan 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: EPAR summary for the public docetaxel
Maltese: Sommarju tal-EPAR għall-pubbliku docetaxel
English: Docetaxel Mylan is a ‘generic medicine'.
Maltese: Docetaxel Mylan huwa ‘mediċina ġenerika'.
English: Docetaxel Mylan is used with cisplatin and 5-fluorouracil.
Maltese: Docetaxel Mylan jintuża ma' cisplatin u 5-fluorouracil.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Mylan on 31 January 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Docetaxel Mylan fil-31 ta' Jannar 2012.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Mylan.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Docetaxel Mylan.
English: The company provided data from the published literature on docetaxel.
Maltese: Il-kumpannija pprovdiet dejta minn dokumentazzjoni ppubblikata dwar docetaxel.
English: Docetaxel Mylan is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Maltese: Docetaxel Mylan jintuża ma' cisplatin u 5-fluorouracil (mediċini oħra kontra l-kanċer).
English: Docetaxel Mylan is used with prednisone or prednisolone (anti-inflammatory medicines);
Maltese: Docetaxel Mylan jintuża ma' prednisone jew prednisolone (mediċini antiinfjammatorji).
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Mylan has been shown to be comparable to Taxotere.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, Docetaxel Mylan intwera li jista' jitqabbel ma' Taxotere.
English: The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva f'Docetaxel Mylan, docetaxel, tagħmel parti mill-grupp ta' mediċini kontra l-kanċer magħrufa bħala taxanes.
English: Docetaxel Mylan is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Maltese: Docetaxel Mylan jintuża biss meta n-numru ta' newtrofili (il-livell ta' tip ta' ċelloli bojod fid-demm) ikun normali (millinqas 1,500 ċellola/mm3).
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Maltese: • adenokarċinoma tal-istonku (tip ta' kanċer fl-istonku) f'pazjenti li għadhom ma rċevew l-ebda trattament għall-kanċer tagħhom.
English: What is Docetaxel Mylan?
Maltese: X'hinu Docetaxel Mylan?
English: This means that Docetaxel Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Maltese: Dan ifisser li Docetaxel Mylan huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Taxotere.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: Jista' jintuża wkoll ma' mediċini oħra kontra l-kanċer (doxorubicin, cyclophosphamide, trastuzumab jew capecitabine), f'pazjenti li jkunu għadhom ma rċevew l-ebda trattament għall-kanċer tagħhom jew wara li jkunu ħadu trattamenti oħra li ma jkunux ħadmu.
English: Why has Docetaxel Mylan been approved?
Maltese: Għaliex ġie approvat Docetaxel Mylan ?
English: Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Mylan infusion.
Maltese: Dexamethasone (mediċina antiinfjammatorja) għandu jingħata wkoll lillpazjent, jum qabel l-infużjoni ta' Docetaxel Mylan.
English: Docetaxel Mylan should be used in wards specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Maltese: Docetaxel Mylan għandu jintuża f'taqsimiet tal-kura speċjalizzati fl-għoti ta' kimoterapija (mediċini għall-kura tal-kanċer) taħt superviżjoni ta' tabib ikkwalifikat fl-għoti ta' kimoterapija.
English: What are the benefits and risks of Docetaxel Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Docetaxel Mylan?
English: Other information about Docetaxel Mylan
Maltese: Kif jintuża Docetaxel Mylan?
English: Because Docetaxel Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Docetaxel Mylan huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: How has Docetaxel Mylan been studied?
Maltese: Kif ġie studjat Docetaxel Mylan?
English: No additional studies were needed as Docetaxel Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali peress li Docetaxel Mylan huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Taxotere.
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: The full EPAR for Descovy 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: Other information about Descovy
Maltese: Informazzjoni oħra dwar Descovy
English: Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Maltese: Tenofovir u emtricitabine huma aġenti antivirali relatati msejħa inibituri ta' traskriptażi inversa.
English: Descovy is available as tablets, each containing 200 mg of emtricitabine and either 10 or 25 mg of tenofovir alafenamide.
Maltese: Descovy huwa disponibbli bħala pilloli, b'kull waħda jkun fiha 200 mg ta' emtricitabine u jew 10 jew 25 mg ta' tenofovir alafenamide.
English: The active substances in Descovy (emtricitabine and tenofovir alafenamide) are already approved to treat HIV infection together with two other active substances (elvitegravir and cobicistat) as part of the combination medicine Genvoya.
Maltese: Is-sustanzi attivi f'Descovy (emtricitabine u tenofovir alafenamide) diġà huma approvati sabiex jikkuraw l-infezzjoni tal-HIV flimkien ma' żewġ sustanzi attivi oħrajn (elvitegravir u cobicistat) bħala parti mill-mediċina ta' kombinazzjoni Genvoya.
English: The company therefore presented data from the studies previously used to approve Genvoya, including 2 studies in 1,733 previously untreated adults, where around 90% of patients responded to treatment, and another study showing benefit was maintained when patients treated with other effective combinations were switched to Genvoya.
Maltese: Għaldaqstant, il-kumpanija ppreżentat data mill-istudji użati preċedentament għall-approvazzjoni ta' Genvoya, inkluż 2 studji f'1,733 adult li ma kinux ikkurati qabel, fejn madwar 90% tal-pazjenti rrispondew għall-kura, u studju ieħor li juri li l-benefiċċju nżamm meta pazjenti kkurati b'kombinazzjonijiet effettivi oħrajn bdew jingħataw Genvoya.
English: Why is Descovy approved?
Maltese: Għaliex ġiet approvat Descovy?
English: Descovy is an antiviral medicine used in combination with other medicines to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Descovy huwa mediċina antivirali li tintuża f'kombinazzjoni ma' mediċini oħrajn fil-kura ta' pazjenti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu talimmunodefiċjenza akkwiżita (AIDS).
English: It is used in adults and adolescents aged over 12 years and who weigh at least 35 kg.
Maltese: Dan jintuża fl-adulti u fl-adolexxenti li għandhom aktar minn 12il sena u li mill-inqas jiżnu 35 kg.
English: Descovy contains the active substances emtricitabine and tenofovir alafenamide.
Maltese: Descovy fih is-sustanzi attivi emtricitabine u tenofovir alafenamide.
English: This is a summary of the European public assessment report (EPAR) for Descovy.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Descovy.
English: Similarly to Genvoya, Descovy offers an alternative option to giving emtricitabine with tenofovir disoproxil
Maltese: B'mod simili għal Genvoya, Descovy joffri għażla alternattiva għall-għoti ta' emtricitabine ma' tenofovir disoproxil
English: What are the risks associated with Descovy?
Maltese: X'inhuma r-riskji assoċjati ma' Descovy?
English: The company also provided data from supporting studies including studies looking at the way Descovy was absorbed in the body.
Maltese: Il-kumpanija pprovdiet ukoll data minn studji ta' appoġġ inkluż studji li jfittxu l-mod kif Descovy kien assorbit fil-ġisem.
English: Other common side effects include diarrhoea and headache.
Maltese: Effetti sekondarji komuni oħrajn jinkludu d-dijarea u uġigħ ta' ras.
English: They block the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected.
Maltese: Dawn jimblokkaw l-attività tat-transkrittażi inversa, enzima prodotta mill-virus li tippermettilha tirreplika lilha nnifisha fiċ-ċelluli li tkun infettat.
English: A risk management plan has been developed to ensure that Descovy is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Descovy jintuża bl-aktar mod sigur possibbli.
English: This summary was last updated in 04-2016.
Maltese: Descovy EMA/169100/2016
English: These studies showed that Descovy produces comparable levels of emtricitabine and tenofovir alafenamide in the body to Genvoya.
Maltese: Dawn l-istudji juru li Descovy jipproduċi livelli komaparabbli ta' emtricitabine u tenofovir alafenamide fil-ġisem għal Genvoya.
English: How is Descovy used?
Maltese: Kif jaħdem Descovy?
English: For the full list of all side effects and restrictions with Descovy, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Descovy, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Descovy?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Descovy?
English: It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Maltese: Dan ma jfejjaqx infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara prodotta lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Descovy contains tenofovir alafenamide which is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects.
Maltese: Desocvy fih tenofovir alafenamide li huwa effikaċi f'doża aktar baxxa mill-mediċina stabbilita tenofovir disoproxil u joffri lpossibbiltà li jnaqqas l-effetti sekondarji.
English: It can only be used in patients who weigh more than 47 kg.
Maltese: Jista' jintuża biss f'pazjenti li jiżnu aktar minn 47 kg.
English: This summary was last updated in 02-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 02-2010.
English: Ribavirin BioPartners is a ‘generic medicine'.
Maltese: Ribavirin BioPartners huwa ‘mediċina ġenerika'.
English: The active substance in Ribavirin BioPartners, ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Maltese: Is-sustanza attiva f'Ribavirin BioPartners, ribavirin, hija antivirali li jappartjeni għall-klassi ta' ‘analogi ta' nukleoside'.
English: This includes adults (aged 18 years and older) who are also infected with human immunodeficiency virus (HIV).
Maltese: Dan jinkludi adulti (ta' 18-il sena u iktar) li huma infettati wkoll bil-virus tal-immunodefiċjenza umana (HIV).
English: Ribavirin BioPartners must never be used on its own but only together with peginterferon alfa 2b or interferon alfa 2b (other medicines used in
Maltese: Ribavirin BioPartners qatt ma għandu jintuża waħdu iżda biss ma' peginterferon alfa 2b jew ma' interferon alfa 2b (mediċini
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ribavirin BioPartners to BioPartners GmbH on 6 April 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għal tqegħid fis-suq valida mal-Unjoni Ewropea kollha għal Ribavirin BioPartners lil BioPartners GmbH fis-6 ta' April 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Ribavirin BioPartners.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ribavirin BioPartners.
English: Because Ribavirin BioPartners is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Rebetol.
Maltese: Minħabba li Ribavirin BioPartners hija mediċina ġenerika, studji f'pazjenti ġew limitati għal testijiet li jiddeterminaw li hija bijoekwivalenti għall-mediċina ta' referenza, Rebetol.