FrancophonIA/ELRC3.0 huggingface dataset:
English: For simpler molecules with well-established action (e.g. filgrastim) and where comparative quality data are solid, it may be sufficient to compare the effect of the biosimilar and reference medicine with PK and PD studies in healthy volunteers.
Maltese: Għal molekuli iktar sempliċi b'azzjoni ferm stabbilita (eż. filgrastim) u meta d-data komparattiva dwar il-kwalità tkun solida, jista' jkun biżżejjed li jitqabbel l-effett talmediċina bijosimili u ta' referenza mal-istudji PK u PD f'voluntiera f'saħħithom.
English: Possible to reproduce the molecule to a high degree of similarity due to unique biomanufacturing methods and natural biological variability
Maltese: Possibbli li tiġi riprodotta l-molekula sa grad għoli ta' similarità minħabba l-metodi uniċi talbijomanifattura u l-varjabbiltà bijoloġika naturali
English: The quality of all medicines (biological and nonbiological) approved in the EU is rigorously proven.
Maltese: Il-kwalità tal-mediċini kollha (bijoloġiċi u mhux bijoloġiċi) approvati fl-UE hi pprovata b'mod rigoruż.
English: The goal is to rule out potential product-related differences that could affect pharmacokinetics (PK), efficacy or safety, including immunogenicity.
Maltese: L-għan hu li tiġi eliminata l-possibbiltà ta' differenzi potenzjali relatati mal-prodott li jistgħu jaffettwaw il-farmakokinetika (PK), l-effikaċja jew is-sikurezza, inkluża l-immunoġeniċità.
English: Clinical data requirements are mainly pharmacokinetic bioequivalence studies
Maltese: Ir-rekwiżiti tad-data klinika huma primarjament studji tal-bijoekwivalenza farmakokinetika
English: Step 2 Comparative non-clinical studies
Maltese: Stadju 2 Studji mhux kliniċi komparattivi
English: For each medicine approved through EMA, including biosimilars, EMA publishes a group of documents known as the european public assessment report (‘EPAR').
Maltese: Għal kull mediċina approvata permezz tal-EMA, inklużi l-bijosimili, l-EMA tippubblika grupp ta' dokumenti magħruf bħala r-rapport pubbliku Ewropew ta' valutazzjoni (“EPAR”).
English: Their assessment reports can be accessed on EMA's website, on the landing page of each medicine, under the tab ‘assessment history'.
Maltese: Ir-rapporti ta' valutazzjoni jistgħu jiġu aċċessati fuq is-sit web talEMA, fuq l-ewwel paġna ta' kull mediċina, taħt ittab “assessment history”.
English: europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500002805.pdf.
Maltese: CPMP/ICH/5721/03. http://www.ema. europa. eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500002805.pdf.
English: Because biosimilars are made in living organisms there may be some minor differences from the reference medicine.
Maltese: Peress li l-bijosimili jsiru f'organiżmi ħajjin, jista' jkun hemm xi differenzi minuri mill-mediċina ta' referenza.
English: Significant change (e.g. changes to the cell system used to produce the active substance)
Maltese: Tibdil sinifikanti (eż. tibdiliet fis-sistema ta' ċelloli użata għall-produzzjoni tas-sustanza attiva)
English: These can differ in size and structural complexity, from simple proteins like insulin or growth hormone to more complex ones such as coagulation factors or monoclonal antibodies (figure 1).
Maltese: Dawn jistgħu jvarjaw fid-daqs u fil-kumplessità strutturali, minn proteini sempliċi bħall-insulina jew ormon tat-tkabbir sa dawk iktar kumplessi bħal fatturi talkoagulazzjoni jew antikorpi monoklonali (figura 1).
English: Most often, analytical and functional data are sufficient, and clinical trials to prove safety and efficacy are not needed (table 5, scenario 1 and 2).
Maltese: Spiss ħafna, id-data analitika u funzjonali tkun biżżejjed, u ma jkunx hemm bżonn ta' provi kliniċi li juru s-sikurezza u l-effikaċja (tabella 5, xenarji 1 u 2).
English: Thus, the active substance in the final biological medicine can have an inherent degree of minor variability
Maltese: B'hekk, is-sustanza attiva fil-mediċina bijoloġika finali jista' jkollha grad inerenti ta' varjabbiltà minuri
English: If patients have questions on whether a particular biological medicine is a biosimilar, their healthcare professionals can find this information in section 5.1 of the SmPC.
Maltese: Jekk il-pazjenti għandhom mistoqsijiet dwar jekk mediċina bijoloġika partikolari hijiex bijosimili, ilprofessjonisti tagħhom fil-kura medika jistgħu jsibu din l-informazzjoni fis-sezzjoni 5.1 tal-SmPC.
English: Comprehensive comparability studies must show that the biosimilar is highly similar to the reference medicine (by means of safety, efficacy and immunogenicity data) in a key indication in a population in which potential differences in clinical performance can be detected.
Maltese: L-istudji komprensivi tal-komparabilità jridu juru li l-bijosimili hi simili ħafna għall-mediċina ta' referenza (permezz ta' data dwar issikurezza, l-effikaċja u l-immunoġeniċità) f'indikazzjoni importanti f'popolazzjoni li fiha jistgħu jiġu identifikati d-differenzi potenzjali filprestazzjoni klinika.
English: This trial should be adequately powered, randomised, parallel-group, preferably doubleblind, and should use efficacy endpoints.
Maltese: Jenħtieġ li l-prova tkun msaħħa b'mod adegwat, aleatorja, bi grupp parallel, idealment double-blind, u jenħtieġ li tuża l-punti ta' tmiem li juru effikaċja.
English: Comparison of data requirements for approval of a biosimilar versus the reference medicine
Maltese: Tqabbil tar-rekwiżiti tad-data għall-approvazzjoni ta' bijosimili meta mqabbla mal-mediċina ta' referenza
English: Variability (yellow shadow) between a biosimilar and the reference medicine is comparable to what may occur between different batches of the same biological medicine (figure 2).
Maltese: Il-varjabbiltà (dell isfar) bejn bijosimili u l-mediċina ta' referenza hi komparabbli għal dik li tista' sseħħ bejn lottijiet differenti tal-istess mediċina bijoloġika (figura 2).
English: Table 2 lists the classes of biological medicines for which biosimilars have been approved in the EU.
Maltese: It-Tabella 2 telenka l-klassijiet ta' mediċini bijoloġiċi li għalihom ġew approvati bijosimili fl-UE.
English: Comparative clinical studies
Maltese: Studji komparattivi mhux kliniċi
English: Clinical immunogenicity studies are generally required for biological medicines.
Maltese: Ġeneralment studji tal-immunoġeniċità klinika huma meħtieġa għal mediċini bijoloġiċi.
English: Biological medicines approved after 1 January 2011 are subject to socalled ‘additional monitoring' and are included in a list of medicines under ‘additional monitoring'.
Maltese: Il-mediċini bijoloġiċi approvati wara l-1 ta' Jannar 2011 huma soġġetti għall-hekk imsejjaħ “monitoraġġ addizzjonali” u huma inklużi f'lista ta' mediċini taħt “monitoraġġ addizzjonali”.
English: Alternatively, a live list of EPAR summaries for all biosimilars can be found on EMA's website.
Maltese: Inkella, lista diretta ta' sommarji tal-EPAR għallbijosimili kollha tista' tinstab fuq is-sit web tal-EMA.
English: Data from a given indication (e.g. rheumatoid arthritis) may not be directly applicable in terms of safety or efficacy to an indication falling within another therapeutic area where the mode of action, posology or pharmacokinetics may be different (e.g. oncology).
Maltese: Data minn indikazzjoni partikolari (eż. artrite rewmatojde) tista' ma tkunx direttament applikabbli f'termini tas-sikurezza jew tal-effikaċja għal indikazzjoni li taqa' taħt qasam terapewtiku ieħor li fih il-modalità ta' azzjoni, il-pożoloġija jew il-farmakokinetika tista' tkun differenti (eż. onkoloġija).
English: In vitro studies compare the protein structure and biological function using sensitive techniques capable of detecting minor differences with clinical relevance between the biosimilar and its reference medicine.
Maltese: Studji in vitro jqabblu l-istruttura tal-proteini u l-funzjoni bijoloġika billi jużaw tekniki sensittivi li kapaċi jindividwaw differenzi minuri b'rilevanza klinika bejn il-bijosimili u l-mediċina ta' referenza tagħha.
English: Glycosylation
Maltese: Bijoekwivalenza
English: Inherent degree of variability
Maltese: Grad inerenti ta' varjabbiltà
English: In cases where clinically relevant immunogenic responses have been observed (e.g. epoetins) immunogenicity testing is more frequent, there is a longer patient follow-up with intensified clinical monitoring, and specific post-marketing studies may be required.
Maltese: F'każijiet li fihom jiġu osservati risponsi immunoġeniċi klinikament rilevanti (eż. epoetini), l-ittestjar tal-immunoġeniċità hu iktar frekwenti, hemm segwitu itwal tal-pazjenti b'monitoraġġ kliniku intensifikat, u jistgħu jkunu meħtieġa studji speċifiċi ta' wara t-tqegħid fis-suq.
English: Implications of the availability of biosimilars
Maltese: Interchangeability of biosimilars: a European perspective.
English: If a suspected ADR is identified for a biological medicine, healthcare professionals should report it, taking care to include the tradename and batch number of the medicine.
Maltese: Jekk tiġi identifikata ADR issuspettata għal mediċina bijoloġika, jenħtieġ li l-professjonisti fil-kura medika jirrapportawha, filwaqt li jaraw li jinkludu l-isem kummerċjali u n-numru tal-lott tal-mediċina.
English: Pharmacokinetic(s)
Maltese: Farmakokinetika
English: However, confirmatory clinical trials with the biosimilar are usually not needed in every indication that has been approved for the reference medicine.
Maltese: Madankollu, provi kliniċi ta' konferma bil-bijosimili normalment ma jkunux meħtieġa f'kull indikazzjoni li ġiet approvata għall-mediċina ta' referenza.
English: Data on biosimilarity: published in the assessment report
Maltese: Id-data dwar il-bijosimilarità: ippubblikata fir-rapport ta' valutazzjoni
English: The aim of biosimilar development is to demonstrate biosimilarity - high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile.
Maltese: L-għan tal-iżvilupp bijosimili hu li tintwera l-bijosimilarità - similarità għolja f'termini tal-istruttura, tal-attività bijoloġika u tal-profil tal-effikaċja, tas-sikurezza u tal-immunoġeniċità.
English: Compared with small chemical substances, biological medicines consist of large and often complex molecular structures.
Maltese: Imqabbla ma' sustanzi kimiċi żgħar, il-mediċini bijoloġiċi jikkonsistu fi strutturi molekulari kbar u spiss kumplessi.
English: This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular microheterogeneity.
Maltese: Dan l-aktar għaliex il-varjabbiltà naturali u l-manifattura iktar kumplessa tal-mediċini bijoloġiċi ma jippermettux replika eżatta talmikroeteroġenità molekulari.
English: Extension of the efficacy and safety data from a therapeutic indication for which the biosimilar has been clinically tested to another therapeutic indication approved for the reference medicine.
Maltese: Dan jevita ripetizzjoni żejda ta' provi kliniċi diġà mwettqa bilmediċina ta' referenza.
English: EMA does not regulate interchangeability, switching and substitution of a reference medicine by its biosimilar.
Maltese: L-EMA ma tirregolax l-interkambjabbiltà, il-qlib u s-sostituzzjoni ta' mediċina ta' referenza millbijosimili tagħha.
English: Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
Maltese: Ċerti bijosimili jistgħu jiġu approvati f'livell nazzjonali, bħal ċerti eparini b'piż molekulari baxx derivati millmukoża intestinali tal-ħnieżer.
English: Since the EU approved the first biosimilar medicine (‘biosimilar') in 2006, the EU has pioneered the regulation of biosimilars.
Maltese: Peress li l-UE approvat l-ewwel mediċina bijosimili (“bijosimili”) fl-2006, l-UE kienet il-pijunier tarregolamentazzjoni tal-bijosimili.
English: Follitropin alfa
Maltese: Kriterji għall-estrapolazzjoni
English: Switching
Maltese: Glikosilazzjoni
English: Development based on demonstration of biosimilarity using comparability studies (comprehensive head-to-head comparison of the biosimilar with the reference medicine to show high similarity in chemical structure, biological function, efficacy, safety and immunogenicity)
Maltese: Żvilupp ibbażat fuq il-wiri tal-bijosimilarità bl-użu ta' studji tal-komparabilità (tqabbil komprensiv ras imb'ras tal-bijosimili mal-mediċina ta' referenza biex tintwera similarità għolja fl-istruttura kimika, fil-funzjoni bijoloġika, fleffikaċja, fis-sikurezza u fl-immunoġeniċità)
English: Consecutive batches of the same biological medicine may show a small degree of variability (yellow shadow) within the accepted ranges, for example in glycosylation (sugar molecules attached to the protein, which are represented by small blue triangles).
Maltese: Lottijiet konsekuttivi tal-istess mediċina bijoloġika jistgħu juru grad baxx ta' varjabbiltà (dell isfar) fi ħdan il-meded aċċettati, pereżempju fil-glikosilazzjoni (molekuli taz-zokkor imqabbda mal-proteina, li huma rappreżentati minn triangoli blu żgħar).
English: The non-clinical and clinical data needed to approve a biosimilar are different from those needed for a biological medicine with a new active substance.
Maltese: Id-data mhux klinika u d-data klinika meħtieġa għall-approvazzjoni ta' bijosimili huma differenti minn dawk meħtieġa għal mediċina bijoloġika b'sustanza attiva ġdida.
English: EMA continues to share the extensive experience gained in the EU on biosimilars with other regulators around the world and participates in a number of international forums such as the International Pharmaceutical Regulators Forum.
Maltese: L-EMA tkompli taqsam l-esperjenza estensiva miksuba fl-UE dwar il-bijosimili ma' regolaturi oħrajn madwar id-dinja u tieħu sehem f'numru ta' forums internazzjonali bħall-Forum Internazzjonali ta' Regolaturi Farmaċewtiċi.
English: These summaries (called ‘EPAR summaries'), are available on each medicine's landing page on EMA's website in the form of questions-andanswers documents in all official EU languages.
Maltese: Dawn is-sommarji (imsejħa “sommarji tal-EPAR”) huma disponibbli fuq l-ewwel paġna ta' kull mediċina fuq issit web tal-EMA fil-forma ta' dokumenti ta' mistoqsijiet u tweġibiet bil-lingwi uffiċjali kollha tal-UE.
English: Same strict standards of quality, safety and efficacy
Maltese: L-istess standards stretti tal-kwalità, tassikurezza u tal-effikaċja
English: For any biological medicine with a new active substance, a positive benefit-risk balance is determined mainly from evidence of safety and efficacy in pivotal trials in humans (figure 4), supported by solid pharmaceutical quality data and non-clinical data.
Maltese: Għal kwalunkwe mediċina bijoloġika b'sustanza attiva ġdida, bilanċ pożittiv bejn ir-riskji u l-benefiċċji hu ddeterminat primarjament minn evidenza tas-sikurezza u tal-effikaċja fi provi pivotali fil-bniedem (figura 4), sostnuta minn data solida dwar il-kwalità farmaċewtika u data mhux klinika.
English: Specific features of biosimilar medicines Highly similar to the reference medicine
Maltese: Karatteristiċi speċifiċi tal-mediċini bijosimili Ferm simili għallmediċina ta' referenza
English: Comparability studies: the cornerstone of biosimilar development
Maltese: Biosimilars: the science of extrapolation.
English: Biological medicines: overview
Maltese: Mediċini bijoloġiċi: ħarsa ġenerali
English: National regulatory authorities in the EU regularly inspect manufacturing sites for compliance with GMP requirements.
Maltese: L-awtoritajiet regolatorji nazzjonali fl-UE jispezzjonaw is-siti tal-manifattura b'mod regolari għall-konformità mar-rekwiżiti tal-PTM.
English: Reference medicine A biological medicine approved in the EU, which is chosen by a company developing a biosimilar as a reference for the head-to-head comparison of quality, safety and efficacy.
Maltese: Mediċina ta' referenza Mediċina bijoloġika approvata fl-UE, li tintgħażel minn kumpanija li tiżviluppa bijosimili bħala referenza għat-tqabbil ras imb ras tal-kwalità, tas-sikurezza u tal-effikaċja.
English: Mostly smaller molecules, easier to characterise In general, larger, structurally more complex molecules, which require multiple technologies for their characterisation
Maltese: B'mod ġenerali, molekuli ikbar u iktar strutturalment kumplessi, li jeħtieġu diversi teknoloġiji biex jiġu kkaratterizzati
English: glucose infusion rate in a glucose clamp study for biosimilar insulins (rather than measures of HbA1c or long-term consequences of diabetes)
Maltese: Ma taffettwax il-kwalità farmaċewtika talmediċina (ebda impatt fuq l-ispeċifikazzjonijiet tal-prodott)
English: The experience over the past 10 years indicates that biosimilar competition can offer advantages to EU healthcare systems, as having more treatment alternatives available is expected to improve patients' access to biological medicines with proven pharmaceutical quality.
Maltese: Il-kompetizzjoni fil-bijosimili tista' toffri vantaġġi lis-sistemi tal-kura tas-saħħa tal-UE, peress li hu mistenni li din ittejjeb l-aċċess tal-pazjenti għal mediċini bijoloġiċi sikuri u effettivi bi kwalità murija bilprovi.
English: Classes of biological medicines for which a biosimilar is currently approved in the EU Classes of biological medicines
Maltese: Klassijiet ta' mediċini bijoloġiċi li għalihom bħalissa hemm bijosimili approvata fl-UE Klassijiet ta' mediċini bijoloġiċi
English: Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilar medicines and their reference medicines.
Maltese: Tul l-aħħar 10 snin, is-sistema ta' monitoraġġ tal-UE ma identifikat l-ebda differenza rilevanti finnatura, fis-severità jew fil-frekwenza tal-effetti avversi bejn il-bijosimili u l-mediċini ta' referenza tagħhom.
English: No clinically meaningful differences compared with the reference medicine
Maltese: L-ebda differenza klinikament sinifikanti meta mqabbla malmediċina ta' referenza
English: Comparative clinical trials are specifically designed to rule out clinically relevant differences in safety or efficacy between the biosimilar and the reference medicine, and to confirm biosimilarity.
Maltese: Provi kliniċi komparattivi huma mfassla b'mod speċifiku biex jeliminaw il-possibbiltà ta' differenzi klinikament rilevanti fis-sikurezza jew fl-effikaċja bejn il-bijosimili u l-mediċina ta' referenza, u biex jikkonfermaw il-bijosimilarità.
English: This involves a comprehensive head-to-head comparison of the biosimilar and the reference medicine (figure 5).
Maltese: Dan jinvolvi tqabbil komprensiv ras imb'ras tal-bijosimili u tal-mediċina ta' referenza (figura 5).
English: Head-to-head comparison of a biosimilar with its reference medicine to rule out any significant differences between them in terms of structure and function.
Maltese: Tqabbil ras imb'ras ta' bijosimili mal-mediċina ta' referenza tagħha biex tiġi eliminata kwalunkwe possibbiltà ta' differenza sinifikanti bejniethom f'termini tal-istruttura u tal-funzjoni.
English: % difference -33.8; 95% CI:
Maltese: % differenza -33.8; 95% CI:
English: Date of latest renewal: 14 January 2013
Maltese: Data tal-aħħar tiġdid: 14 ta' Jannar 2013
English: P-value, Log-rank test
Maltese: Valur P, Test Log-rank
English: Polyvinyl alcohol (partially hydrolysed) Talc (E553b)
Maltese: Polyvinyl alcohol (parzjalment idroliżżat) Talc (E553b)
English: Odds ratio 1.56; 95% CI: 1.05,
Maltese: Proporzjon ta' probabbiltà 95% CI: 1.05,
English: Difference and Confidence Interval p value
Maltese: Differenza u Intervall ta' Kunfidenza valur p
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
English: 22.75m; 95% CI: 12.00, 33.50 p<0.0001
Maltese: 22.75m; 95% CI: 12.00, 33.50
English: The mean age of all patients was 54 years (SD 15; range 18-75 years of age).
Maltese: L-età medja tal-pazjenti kollha kienet ta' 54 sena (SD 15; medda ta' 18-75 sena).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 April 2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' April 2008
English: Lecithin (soya) (E322) Allura red AC Aluminium Lake (E129)
Maltese: Lecithin (sojja) (E322) Allura red AC Aluminium Lake (E129)
English: Don't take Volibris:
Maltese: Tieħux Volibris:
English: Patients WHO FC at baseline was II (31%) and FC III (69%).
Maltese: FC talpazjenti fil-linja bażi kienet FC II (31%) u FC III (69%).
English: Ambrisentan is primarily bound to albumin (96.5%) and to a lesser extent to alpha1-acid glycoprotein.
Maltese: Ambrisentan jintrabat primarjament mal-albumina (96.5%) u ftit anqas minn hekk mal-glikoproteina alpha1-acid.
English: Manufacturer Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany
Maltese: Aspen Bad Oldesloe GmbH Industriestrasse 32-36
English: Volibris contains the active substance ambrisentan.
Maltese: Volibris fih is-sustanza attiva ambrisentan.
English: The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
Maltese: Is-sustanzi l-oħra huma: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stereate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, lecithin (sojja) (E322) u Allura red AC Aluminium Lake (E129).
English: Volibris 10 mg film-coated tablets EU/1/08/451/003
Maltese: Volibris 10 mg pilloli miksija b'rita EU/1/08/451/003
English: The majority of patients had WHO functional Class II (38.4%) or Class III (55.0%) symptoms.
Maltese: Il-maġġoranza ta' pazjenti kellhom sintomi Klassi funzjonali WHO II (38.4%) jew Klassi III (55.0%).
English: Immune system disorders Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Maltese: Disturbi fis-sistema immuni Reazzjonijiet ta' sensittività eċċessiva (eż. anġjoedima, raxx, ħakk)
English: • Ambrisentan is a potent (Ki 0.016 nM) and highly selective ETA antagonist (approximately 4000-fold more selective for ETA as compared to ETB).
Maltese: • Ambrisentan huwa antagonist ETA potenti (Ki 0.016M) u selettiv ħafna (bejn wieħed u ieħor 4000-darba aktar selettiv għal ETA meta mqabbel ma' ETB).
English: In vitro data indicate that ambrisentan at 300 μM resulted in less than 50 % inhibition of UGT1A1, UGT1A6, UGT1A9, UGT2B7 (up to 30%) or of cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 (up to 25%).
Maltese: Dejta in vitro tindika li ambrisentan fi 300 μM irriżulta f'inqas minn inibizzjoni ta' 50 % ta' UGT1A1, UGT1A6, UGT1A9, UGT2B7 (sa 30%) jew ta' enzimi ta' P450 ta' cytochrome 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4 (sa 25%).
English: Volibris tablets contain lecithin derived from soya.
Maltese: Il-pilloli Volibris fihom lecithin derivat mis-sojja.
English: Tadalafil monotherapy (N=121)
Maltese: Monoterapija b'Tadalafil (N=121)
English: The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily)
Maltese: L-effetti ta' dożi ripetuti ta' cyclosporine A (100 - 150 mg darbtejn kuljum) fuq il-farmakokinetika fi stat fiss ta' ambrisentan (5 mg darba kuljum), u l-effetti ta' dożi ripetuti ta' ambrisentan (5 mg darba kuljum) fuq il-farmakokinetiċi ta' cyclosporine A (100 - 150 mg darbtejn kuljum) ġew studjati f'voluntiera b'saħħithom.
English: ARIES-2 included 192 patients and compared ambrisentan 2.5 mg and 5 mg with placebo.
Maltese: ARIES 2 kien jinkludi 192 pazjent u pparaguna ambrisentan 2.5 mg u 5 mg ma' plaċebo.