FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, the available efficacy data showed only limited efficacy in support of the claimed indications of local fusafungine in rhinopharyngitis which does not translate in evidence of a benefit for patients in the current context of the therapeutic clinical practice.
Maltese: Barra minn hekk, id-data tal-effikaċja disponibbli wriet effikaċja limitata biss f'appoġġ talindikazzjonijiet iddikjarati ta' fusafungine lokali fir-rinofarinġite li ma jsarrafx f'evidenza ta' benefiċċju għal pazjenti fil-kuntest attwali tal-prattika klinika terapewtika.
English: The MAH was asked to provide a cumulative review of all case reports, both serious and non-serious, along with causality assessment for serious cases and stratification by age as well as analyses on age and sex of patient, indication of use, duration and dose, time to onset, outcome, seriousness, concomitant medications and illnesses, relevant medical history or any other factors.
Maltese: Il-MAH kien mitlub jipprovdi reviżjoni kumulattiva tar-rapporti tal-każijiet kollha, kemm serji kif ukoll mhux serji, flimkien ma' valutazzjoni tal-kawżalità għal każi serji u stratifikazzjoni permezz tal-età kif ukoll analiżi dwar l-età u s-sess tal-pazjent, indikazzjoni dwar l-użu, it-tul ta' żmien u ddoża, iż-żmien għall-bidu, ir-riżultat, is-serjetà, il-mediċini u l-mard konkomitanti, l-istorja medika rilevanti jew kwalunkwe fattur ieħor.
English: The advice of the CHMP Scientific Advisory Group (SAG) in Anti-Infectives was requested by the PRAC.
Maltese: Il-PRAC talab il-parir tal-Grupp ta' Konsulenza Xjentifika (SAG) tas-CHMP dwar l-Anti-Infettivi.
English: In addition, although there is insufficient evidence to conclude on potential risk of inducing bacterial resistance, the risk of cross-resistance cannot be excluded.
Maltese: Ir-riskju ta' reżistenza inkroċjata lanqas ma jista' jiġi eskluż.
English: The PRAC acknowledged that specific information on the efficacy of fusafungine in documented infections sustained by streptococcus pyogenes or viridans could not be provided.
Maltese: Il-PRAC fehem li informazzjoni speċifika dwar l-effikaċja ta' fusafungine f'infezzjonijiet dokumentati sostnuti minn treptococcus pyogenes jew viridans ma tistax tiġi pprovduta.
English: The PRAC noted that no established susceptibility interpretive criteria (clinical breakpoints) for fusafungine were determined by EUCAST (European Committee for Antibacterial Susceptibility Testing) in Europe or CLSI (Clinical and Laboratory Standards Institution) in the US.
Maltese: Il-PRAC innota li ma ġewx iddeterminati kriterji ta' interpretazzjoni dwar is-suxxetibbiltà stabbilita (valuri tal-limiti kliniċi) għal fusafungine mill-EUCAST (Kumitat Ewropew dwar it-Testijiet tas-Suxxettibbiltà) fll-Ewropa jew CLSI (Istitut ta' Kriterji Kliniċi u talLaboratorju) fl-Istati Uniti.
English: It was also noted that while EUCAST is currently recommending to use epidemiological cut-off values (ECOFFs) for topical agents, in particular when clinical breakpoints are not available, ECOFFs for fusafungine are not available on the EUCAST website.
Maltese: Kien innotat li filwaqt li attwalment il-EUCAST qiegħed jirrakkomanda lużu tal-valuri epidemjoloġiċi tal-qtugħ (ECOFFs) għal aġenti topiċi, b'mod partikolari meta l-valuri tal-limiti kliniċi mhumiex disponibbli, l-ECOFFs ta' fusafungine mhumiex disponibbli fuq is-sit web tal-EUCAST.
English: In addition, concerns have also been raised with regards to the role of the excipients in the occurrence of allergic reactions.
Maltese: ADRs li jirreferu għal reazzjonijiet allerġiċi.
English: The in vitro and in vivo data can be generally regarded as supportive of anti-inflammatory effect of fusafungine although the mechanism of action of antiinflammatory activity of fusafungine is complex and remains unknown.
Maltese: Id-data in vitro u in vivo tista' tkun ġeneralment meqjusa bħala waħda ta' appoġġ tal-effett antiinfjammatorju ta' fusafungine għalkemm il-mekkaniżmu ta' azzjoni tal-attività anti-infjammatorja ta' fusafungine huwa kumpless u jibqa' mhux magħruf.
English: FFU*** ................................................................................................................................................per 0.2 ml dose
Maltese: FFU*** ............................................................................................................................................................. f'kull doża ta' 0.2 ml
English: EU/1/10/661/002
Maltese: EU/1/10/661/002 FLUENZ -
English: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029) 10
Maltese: Virus tal-influwenza reassortant* (ħaj attenwat) tar-razez li ġejjin**: A/California/7/2009 razza qisha (H1N1)pdm09 (A/California/7/2009, MEDI 228029)
English: Nasal use sprayer (glass/PE) 0.2ml
Maltese: Użu għall-imnieħer sprayer (ħġieġ/PE)
English: * propagated in fertilised hens' eggs from healthy chicken flocks.
Maltese: * ippropagat f'bajd fertilizzat tat-tiġieġ minn gruppi ta' tiġieġ b'saħħithom.
English: Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Elevated circulating levels of Chromogranin A (EPITT no 18614)
Maltese: Inibituri tal-pompa tal-protoni (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Livelli li jiċċirkolaw elevati ta' Kromogranin A (EPITT nru 18614)
English: Ferrous sulfate - Mouth ulceration (EPITT no 18623)
Maltese: Ferrous sulfate - Ulċerazzjoni tal-ħalq (EPITT nru 18623)
English: Adopted at the 4-8 July 2016 PRAC
Maltese: Adottati fil-PRAC ta' bejn l-4-8 ta' Mejju 2016
English: To avoid this interference, [Product name] treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Maltese: Biex din l-interferenza tiġi evitata, il-kura bi [Isem tal-prodott] għandha titwaqqaf għal mill-inqas 5 ijiem qabel il-kejl ta' CgA (ara sezzjoni 5.1).
English: Method of administration:
Maltese: Wara t-tqegħid fis-suq:
English: • You are due to have a specific blood test (Chromogranin A)
Maltese: • Inti wasalt biex ikollok test tad-demm speċifiku (Kromogranin A)
English: Not known (frequency cannot be estimated from the available data) Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth) Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.
Maltese: Ulċerazzjoni tal-ħalq (fil-każ ta' użu inkorrett, meta l-pilloli jintmagħdu, jiġu msoffija jew jitħallew filħalq) Pazjenti anzjani u pazjenti b'diffikultà biex jibilgħu jistgħu jkunu f'riskju ta' ulċerazzjoni talgerżuma, esofagu (it-tubu li jgħaqqad il-ħalq mal-istonku tiegħek) jew mal-bronki (il-passaġġi tal-arja maġġuri tal-pulmuni) jekk il-pillola tidħol fil-passaġġi tal-arja.
English: The frequency of these reactions is considered not known (cannot be estimated from the available data).
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli).
English: If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Maltese: Jekk il-livelli ta' CgA u gastrin ma jkunux irritornaw għall-medda ta' referenza wara kejl inizjali, il-kejl jenħtieġ li jiġi ripetut 14-il jum wara lwaqfien tal-kura tal-inibitur tal-pompa tal-proton.
English: Gastrointestinal disorders: mouth ulceration* * in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth.
Maltese: Disturbi gastrointestinali: ulċerazzjoni tal-ħalq* * fil-kuntest ta' amministrazzjoni mhux korretta, meta l-pilloli jiġu msoffija, jintmagħdu jew jinżammu fi-ħalq.
English: The increased CgA level may interfere with investigations for neuroendocrine tumours.
Maltese: Il-livell ta' CgA miżjud jista' jinterferixxi mal-investigazzjonijiet għal tumuri newroendokrinali.
English: Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.
Maltese: Pazjenti anzjani u pazjenti b'disturbi ta' deglutinazzjoni jistgħu jkunu wkoll f'riskju ta' leżjonijiet esofaġeali jew ta' nekrożi bronkjali, fil-każ ta' rotta falza.
English: Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.
Maltese: Il-pilloli jenħtieġ li jittieħdu qabel l-ikel jew matul l-ikel, jiddependi mit-tolleranza gastrointestinali.
English: Post-marketing: The following ADRs have been reported during post-marketing surveillance.
Maltese: L-ADRs li ġejjin ġew irrapportati matul is-sorveljanza ta' wara t-tqegħid fissuq.
English: The application was withdrawn before ‘day 120'.
Maltese: L-applikazzjoni ġiet irtirata qabel ‘jum 120'.
English: What is Epostim?
Maltese: X'inhu Epostim?
English: A second main study in 188 kidney patients compared Epostim with the reference medicine Eprex.
Maltese: It-tieni studju prinċipali li sar fuq 188 pazjent bi problemi fil-kliewi qabbel Epostim mal-mediċina ta' referenza Eprex.
English: Epostim was developed as a ‘biosimilar' medicine.
Maltese: Epostim kien żviluppat bħala mediċina ‘bijosimili'.
English: The reference medicine for Epostim is Eprex.
Maltese: Il-mediċina ta' referenza għal Epostim hija Eprex.
English: The epoetin alfa in Epostim is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Maltese: L-epoetina alfa f'Epostim huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': dan huwa magħmul permezz ta' ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi li tipproduċih.
English: Epostim is a solution for injection that contains the active substance epoetin alfa.
Maltese: Epostim huwa soluzzjoni għal injezzjoni li fih s-sustanza attiva epoetina alfa.
English: On 15 March 2011, Reliance GeneMedix Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epostim to be used to treat anaemia and stimulate red blood cell production.
Maltese: Fil-15 ta' Marzu 2011, Reliance GeneMedix Plc għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal Epostim li għandu jintuża fil-kura tal-anemija u jistimula l-produzzjoni taċ-ċelloli tad-demm ħomor.
English: In a main study in 75 adults with anaemia caused by kidney problems, patients were treated with Epostim and their blood levels of haemoglobin (a protein in red blood cells) measured to see how much their anaemia improved.
Maltese: Fi studju prinċipali li sar fuq 75 adult bl-anemija kkawżata minn problemi tal-kliewi, ilpazjenti ġew ikkurati b'Epostim u l-livelli ta' emoglobina (proteina fiċ-ċelloli tad-demm ħomor) fiddemm tagħhom tkejlu biex jiġi osservat kemm kien hemm titjib fl-anemija tagħhom.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar mediċini bijosimili, ara d-dokument ta' mistoqsija u tweġiba hawn.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
Maltese: • fil-kura tal-anemija (għadd baxx taċ-ċelloli tad-demm ħomor) li tkun qiegħda tikkawża sintomi fladulti u t-tfal li għandhom ‘insuffiċjenza renali kronika' (tnaqqis progressiv fuq perjodu ta' żmien twil, fil-kapaċità tal-kliewi li jaħdmu kif suppost);
English: What was Epostim expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Epostim?
English: The effects of Epostim were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Epostim ġew l-ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbnedmin.
English: • to reduce the need for blood transfusions in non-iron deficient patients who are about to undergo major orthopaedic (bone) surgery.
Maltese: • biex inaqqas il-ħtieġa ta' trasfużjonijiet tad-demm fil-pazjenti li ma għandhomx defiċjenza ta' ħadid li jkunu sejrin jagħmlu kirurġija ortopedika (tal-għadam) maġġuri.
English: The active substance in Epostim, epoetin alfa, is a copy of human erythropoietin and was expected to work in exactly the same way as the natural hormone to stimulate red blood cell production.
Maltese: Is-sustanza attiva f'Epostim, l-epoetina alfa, hija kopja tal-eritropojetina uman u kienet mistennija li taħdem eżattament bl-istess mod bħall-ormon naturali biex tistimula l-produzzjoni taċ-ċelloli taddemm ħomor.
English: This means that Epostim was intended to be similar to a biological medicine that is already authorised in the European Union (also known as the ‘reference medicine') and contains the same active substance.
Maltese: Dan ifisser li Epostim kien maħsub biex ikun simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (magħrufa wkoll bħala l-‘mediċina ta' referenza') u fih l-istess sustanza attiva.
English: Erythropoietin is produced by the kidneys.
Maltese: L-eritropojetina jiġi prodott mill-kliewi.
English: A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Maltese: Ormon magħruf bħala eritropojetina (erythropoietin) jistimula l-produzzjoni taċ-ċelloli tad-demm ħomor mill-mudullun.
English: This was then compared with results reported in the scientific literature.
Maltese: Dan imbagħad tqabbel ma' riżultati rrapportati fid-dokumentazzjoni xjentifika.
English: Page 2/2
Maltese: Mistoqsijiet u Tweġibiet
English: 1 vial + 1 pre-filled syringe + 2 separate needles
Maltese: 1 kunjett + 1 siringa mimlija għal-lest + 2 labar separati
English: 1 vial + 1 pre-filled syringe + 1 separate needle
Maltese: 10 kunjetti + 10 siringi mimlijin għal-lest + 10 labar separati
English: 06 March 2012
Maltese: 06 ta' Marzu 2012
English: EMA/CHMP/966954/2011 Rev. 1 EMEA/H/A-13/1304
Maltese: EMA/CHMP/966954/2011 Rev.
English: What is Norditropin?
Maltese: X'inhu Norditropin?
English: Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom1.
Maltese: Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja u r-Renju Unit1.
English: On 20 April 2011, Denmark referred the matter to the CHMP for arbitration.
Maltese: Fl-20 ta' April 2011, id-Danimarka rreferiet il-kwistjoni lis-CHMP għal arbitraġġ.
English: 1 In May 2011 the marketing authorisations of the concerned products were withdrawn in Estonia, and in June 2011 the marketing authorisations of the concerned products were withdrawn in Latvia.
Maltese: 1 F'Mejju 2011 l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti kkonċernati ġew irtirati fl-Estonja, u f'Ġunju 2011 lawtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti kkonċernati ġew irtirati fil-Latvja.
English: In May 2010, the company applied for an additional indication in Denmark and in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Maltese: F'Mejju 2010, il-kumpanija applikat għal indikazzjoni addizzjonali fidDanimarka u fl-Istati Membri li ġejjin: l-Awstrija, il-Belġju, il-Bulgarjia, Ċipru, ir-Repubblika Ċeka, l
English: The somatropin in Norditropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes the organism able to produce it. Norditropin is marketed in the EU Member States under the names Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx and associated names.
Maltese: Norditropin jiġi kummerċjalizzat fl-Istati Membri tal-UE bl-ismijiet ta' Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx u ismijiet assoċjati.
English: Why was Norditropin reviewed?
Maltese: Għaliex saret reviżjoni ta' Norditropin?
English: The company that makes the medicine is NovoNordisk.
Maltese: Il-kumpanija li timmanifattura l-mediċina hija NovoNordisk.
English: Norditropin is used as replacement therapy in children and adults who have a growth hormone deficiency.
Maltese: Norditropin jintuża bħala terapija ta' sostituzzjoni fit-tfal u l-adulti li għandhom defiċjenza tal-ormon tat-tkabbir.
English: Norditropin is a medicine that contains somatropin, which is a copy of naturally occurring human growth hormone.
Maltese: Norditropin huwa mediċina li fiha somatropin, li hija kopja ta' ormon tat-tkabbir uman li huwa disponibbli b'mod naturali.
English: Norditropin is authorised under a mutual recognition procedure based on an initial authorisation granted by Denmark.
Maltese: Norditropin huwa awtorizzat bi proċedura ta' rikonoxximent reċiproku bbażata fuq awtorizzazzjoni inizjali mogħtija mid-Danimarka.
English: The European Commission issued a decision on 06 March 2012.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fis-6 ta' Marzu 2012.
English: Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Maltese: L-ormon tat-tkabbir jippromwovi t-tkabbir matul it-tfulija u l-adoloxxenza, u jaffettwa anki l-mod kif il-ġisem jamministra l-proteini, ix-xaħam u l-karboidrati.
English: The new indication was for the use of Norditropin in children with Prader-Willi syndrome, a rare genetic disease that affects children's growth and development.
Maltese: L-indikazzjoni l-ġdida kienet għall-użu ta' Norditropin fit-tfal bissindromu ta' Prader-Willi, marda ġenetika rari li taffettwa t-tkabbir u l-iżvilupp tat-tfal.
English: The Member States cited methodological weaknesses in the study presented, the wide range of doses used and insufficient data (e.g. missing data on body composition measurements).
Maltese: L-Istati Membri ċċitaw dgħjufijiet metodoloġiċi fl-istudju ppreżentat, il-firxa wiesgħa ta' dożi użati u d-dejta insuffiċjenti (eż. dejta nieqsa dwar il-kejl tal-kompożizzjoni tal-ġisem).
English: The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ għal Norditropin u ismijiet assoċjati.
English: The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome.
Maltese: Ir-raġuni għar-referenza kien it-tħassib ta' wħud mill-Istati Membri li d-dejta dwar Norditropin sottomessa fl-applikazzjoni ma kinitx biżżejjed sabiex turi l-effikaċja tiegħu fis-sindromu ta' PraderWilli.
English: Gastro-resistant tablet
Maltese: Magensaftresistente Tablette
English: The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Olinka application was UK and the Concerned Member States (CMS) were: Germany and Poland.
Maltese: L-Istat Membru ta' Referenza (RMS) għall-proċedura deċentralizzata għal applikazzjoni ta' Pantoprazole Olinka kien ir-Renju Unit u l-Istati Membri Kkonċernati (CMS) kienu: ir-Repubblika Ċeka, il-Ġermanja, ilPolonja u r-Repubblika Slovakka.
English: Pantoprazole 20 mg Volkspharma Gastroresistant tablets
Maltese: Pantoprazole 20 mg Volkspharma
English: Pantoprazole 40 mg Volkspharma Gastroresistant tablets
Maltese: Pantoprazole 40 mg Volkspharma
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan huwa mediċina antivirali li tintuża fil-kura ta' adulti li jkunu infettati bil-virus tal-immunodefiċjenza umana 1 (HIV-1, human immunodeficiency virus-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS, acquired immune deficiency syndrome).
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: Din il-mediċina fiha tliet sustanzi attivi: efavirenz, li huwa inibitur mhux nukleosidiku tat-traskriptażi inversa (NNRTI, non-nucleoside reverse transcriptase inhibitor); emtricitabine, li huwa inibitur nukleosidiku tat-traskriptażi inversa; u tenofovir disoproxil, li huwa ‘prodroga' ta' tenofovir, jiġifieri li jinbidel fis-sustanza attiva tenofovir fil-ġisem.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Maltese: Informazzjoni oħra dwar Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
English: The medicine contains the active substances efavirenz, emtricitabine and tenofovir disoproxil and is a ‘generic medicine'.
Maltese: Il-mediċina fiha s-sustanzi attivi efavirenz, emtricitabine u tenofovir disoproxil u hija ‘mediċina ġenerika'.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Maltese: Il-kumpanija li tqiegħed il-mediċina fis-suq se tiżgura li t-tobba kollha li mistennija jippreskrivu lmediċina jiġu pprovduti b'pakkett edukattiv li jinkludi informazzjoni dwar ir-riskju miżjud ta' mard fil
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Atripla, u m'għandhomx għalfejn jiġu ripetuti għal Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk talmediċina ta' referenza.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan keeps the amount of HIV in the blood at a low level.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan iżomm l-ammont ta' HIV fid-demm f'livell baxx.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Maltese: Kemm inibituri nukleosidiċi kif ukoll nukleotidiċi tat-traskriptażi inversa huma magħrufa b'mod komuni bħala NRTIs.
English: Ruconest conestat alfa
Maltese: Ruconest konestat alfa
English: This summary was last updated in 01-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 01-2017.
English: Ruconest contains the active substance conestat alfa.
Maltese: Ruconest fih is-sustanza attiva konestat alfa.
English: Other information about Ruconest
Maltese: Informazzjoni oħra dwar Ruconest
English: The full EPAR for Ruconest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Ruconest jinstab fis-sit elettroniku tal-Aġenzija taħt EMA website/Find medicine/Human medicines/European Public Assessment Reports.