FrancophonIA/ELRC3.0 huggingface dataset:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF UMAN BIG
Maltese: Finalment, id-dokumenti kkwotati mill-Applikant jindikaw li UMAN
English: The BPWP noted that a guideline would not be helpful for currently ongoing applications but that a combined Guideline on the data expected to support applications for specific immunoglobulins against hepatitis B, varicella, tetanus, tick-borne encephalitis and rabies, for which there is currently only a core SPC.
Maltese: Il-BPWP ikkunsidra li d-dejta minn studji prekliniċi ma tipprovdix xi informazzjoni addizzjonali li tikkonċerna l-immunoglobulina attwali u li spiss, id-dejta dwar is-sustanzi mhux attivi hija neċessarja.
English: Moreover, the potential risk of transmitting infective agents through administration of anti hepatitis B immunoglobulins is only theoretical due to the state of the art knowledge and procedures for quality control.
Maltese: Barra minn hekk, ir riskju potenzjali li jiġu trasmessi aġenti infettivi permezz tat-teħid ta' immunoglobulini kontra l epatite B huwa biss teoriku minħabba l-għarfien u l-proċeduri mill-aktar moderni għall-kontroll tal kwalità.
English: According to the Applicant, the characteristics of the product, the available safety data, and the overall safety system in place do not warrant any recommendations for further risk minimisation activities.
Maltese: Skont l-Applikant, il-karatteristiċi talprodott, id-dejta disponibbli dwar is-sigurtà, u s-sistema ta' sigurtà globali fis-seħħ ma jeħtiġux rakkomandazzjonijiet għal attivitajiet oħra għat-tnaqqis tar-riskji.
English: Whereas - the CHMP considered that the post marketing safety data submitted are adequate to establish the positive safety profile of UMAN BIG, - the CHMP considered the efficacy profile of UMAN BIG to be satisfactory for the indications applied for in the SPC, - the CHMP considered that the benefit/risk of UMAN BIG is positive, the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination Group procedure as mentioned in Annex III for UMAN BIG.
Maltese: L-Applikant iddikjara li l-unika miżura rilevanti tal-effikaċja għal dan it-tip ta' prodott hija l-livell ta' anti-HBs protettivi miksubin fil-plażma, billi wara l-introduzzjoni ta' tilqima, ma jibqax fattibbli li tiġi valutata l-effikaċja tal-prodott fuq il-bażi tal-inċidenza ta' infezzjonijiet ġodda.
English: Content (concentration)
Maltese: FARMAĊEWTIĊI), QAWWA (QAWWIET)
English: The study was performed in different populations and in much higher posology than recommended in the relevant core SPC because the Applicant considered that the indications, posology and pharmacokinetic information reported in the core SPC are not product specific, but rather that they apply to products complying with the relative European Pharmacopoeia monograph, such as UMAN BIG.
Maltese: L-istudju sar f'popolazzjonijiet differenti u f'pożoloġija ħafna ogħla minn dik speċifikata flSPC ewlieni għax l-Applikant ikkunsidra li l-indikazzjonijiet, il-pożoloġija u l-informazzjoni farmakokinetika rrappurtata fl-SPC ċentrali mhumiex speċifiċi għall-prodott, iżda li japplikaw għal prodotti li huma konformi mal-monografija tal-Farmakopea Ewropea relattiva, bħal UMAN
English: The BPWP considered that post marketing safety data generated in only one EU member state can be adequate to define the safety profile of the product provided that the quality of the data and the Pharmacovigilance system is sufficient.
Maltese: Il-BPWP ikkunsidra li d-dejta ta' sigurtà wara t-tqegħid fis-suq iġġenerata fi Stat Membru tal-UE wieħed biss tista' tkun xierqa biex tiddefinixxi l-profil ta' sigurtà tal-prodott sakemm il-kwalità taddejta u s-sistema ta' Farmakoviġilanza ikunu biżżejjed.
English: The procedure was therefore referred to the CHMP in October 2008.
Maltese: BIG imfissra mill-BWPW f'rapport datat is-27 ta' Novembru 2008.
English: Does the BPWP consider necessary the development of a specific Note for Guidance on the Clinical Investigation of Human Plasma derived Hepatitis-B Immunoglobulins to outline requirements particularly with regard to the design of the clinical studies and the required safety data for the claimed indications?
Maltese: Il-BPWP jikkunsidra neċessarju l-iżvilupp ta' Nota speċifika għal Gwida dwar lInvestigazzjoni Klinika tal-Immunoglobulini tal-Epatite B derivata mill-Plażma Umana biex jiġu deskritti r-rekwiżiti partikolarment fir-rigward tad-disinn tal-istudji kliniċi u d-dejta dwar is-sigurtà meħtieġa għall-indikazzjonijiet iddikjarati?
English: The BPWP considered that UMAN BIG adheres to the Ph. Eur.
Maltese: Il-CHMP innota li UMAN
English: Furthermore, published data from non-sponsor driven studies using UMAN BIG in the prophylaxis of hepatitis B in approximately 1000 newborns of HBsAg carrier mothers was submitted.
Maltese: BIG fil-profilassi tal-epatite B f'bejn wieħed u ieħor 1000 tarbija tat-twelid minn ommijiet li jġorru l-HbsAg.
English: Should non-clinical product-specific safety data be submitted for this product, in line with point 5.3 the Core SPC for human Immunoglobulin for IV administration?
Maltese: 3. Għandha tkun sottomessa dejta dwar is-sigurtà mhux klinika speċifika għall-prodott, skont ilpunt 5.3 tal-SPC ewlieni għall-Immunoglobulina umana għal amministrazzjoni
English: In addition, the Applicant submitted several clinical studies conducted in populations that are representative of the populations indicated in the SPC as bibliographic reference, which confirm the efficacy of UMAN BIG in the claimed indications.
Maltese: Barra minn hekk, lApplikant issottometta diversi studji kliniċi mwettqa f'popolazzjonijiet li huma rappreżentattivi talpopolazzjonijiet indikati fl-SPC bħala referenza bibljografika, li jikkonfermaw l-effikaċja ta' UMAN
English: There are enough data regarding the safety and PK of UMAN BIG in newborns, administered for the prevention of HBV transmission from HBsAg infected mothers.
Maltese: BIG fit-trabi tat-twelid, meħud għallprevenzjoni tat-trasmissjoni tal-HBV minn ommijiet infettati bl-HBsAg.
English: Doxycycline is a semi-synthetic tetracycline antibiotic.
Maltese: Doxycycline huwa antibijotiku tetracycline semi-sintetiku.
English: Written explanations were provided by the applicant/marketing authorisation holder on 15 October 2010 and 8 March 2011.
Maltese: Ingħataw spjegazzjonijiet bil-miktub mill-applikant/detentur tal-awtorizzazzjoni għattqegħid fis-suq fil-15 ta' Ottubru 2010 u fit-8 ta' Marzu 2011.
English: Opinion following an Article 34 referral for Doxyfar 50% and associated names
Maltese: Opinjoni wara riferiment tal-Artikolu 34 għal Doxyfar 50% u l-ismijiet assoċjati
English: Doxyfar 50 % and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g.
Maltese: Doxyfar 50 % u l-ismijiet assoċjati huwa trab sabiex jintuża fl-ilma tax-xorb, li fih is-sustanza attiva doxycycline hyclate 500 mg/g.
English: Due to divergent national decisions taken by Member States regarding the target species, indications, amounts to be administered and withdrawal periods concerning the authorisation of Doxyfar 50% and associated names, on 18 June 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised summary of product characteristics across the European Union.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri dwar l-ispeċi mira, lindikazzjonijiet, l-ammonti li għandhom jingħataw u l-perjodi ta' tiżmim dwar l-awtorizzazzjoni ta' Doxyfar 50% u l-ismijiet assoċjati, fit-18 ta' Ġunju 2010, ir-Renju Unit irrefera l-kwistjoni lis-CVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE, sabiex jiġu solvuti diverġenzi forst il-karatteristiċi talprodott fil-qosor awtorizzati fuq livell nazzjonali fl-Unjoni Ewropea kollha.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Doxyfar 50% and associated names remains positive subject to variation of the marketing authorisations in accordance with the summary of product characteristics, and therefore adopted a positive opinion on 4 May 2011.
Maltese: Fuq il-bażi tal-valutazzjoni tar-rapporteurs tad-dejta disponibbli attwalment, is-CVMP ikkunsidra li lprofil ta' benefiċċju/riskju għal Doxyfar 50% u l-ismijiet assoċjati jibqa' pożittiv, bil-kundizzjoni li jiġu rraportati l-modifiki fl-awtorizzazzjonijiet għat-tqegħid fis-suq skont il-karatteristiċi tal-prodott filqosor, u għaldaqstant adottaw opinjoni pożittiva fl-4 ta' Mejju 2011.
English: EMA/597493/2015 EMEA/H/C/003759
Maltese: EMA/597493/2015 EMA/H/C/003759
English: Intuniv guanfacine
Maltese: Intuniv gwanfaċina
English: The medicine is available as tablets (1, 2, 3 and 4 mg).
Maltese: Il-mediċina tiġi bħala pilloli (1, 2, 3 u 4 mg).
English: The full EPAR and risk management plan summary for Intuniv 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: This is a summary of the European public assessment report (EPAR) for Intuniv.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Intuniv.
English: Intuniv is used as part of a comprehensive treatment programme that typically involves psychological, educational and other interventions.
Maltese: Intuniv jintuża bħala parti minn programm ta' kura komprensiva li ġeneralment tinvolvi interventi psikoloġiċi, edukattivi u interventi oħrajn.
English: In a study of 337 children aged 6 to 17 years, the reduction in ADHD symptoms with Intuniv treatment after 10 to 13 weeks was 24 points compared with a reduction of 15 points seen with placebo (a dummy treatment) and 19 points seen with atomoxetine (an ADHD medicine).
Maltese: Fi studju ta' 337 tifel u tifla li kellhom bejn 6 u 17-il sena, it-tnaqqis fis-sintomi tal-ADHD bil-kura b'Intuniv wara 10 sa 13-il ġimgħa kien ta' 24 punt meta mqabbel ma' tnaqqis ta' 15-il punt osservat bi plaċebo (kura finta) u 19-il punt osservat b'atomoxetine (mediċina kontra ADHD).
English: Several studies have shown Intuniv improving ADHD symptom scores (ADHD-RS-IV) in children and adolescents.
Maltese: Diversi studji wrew li Intuniv itejjeb il-punteġġi ta' sintomi ta' ADHD (ADHD-RS-IV) fit-tfal u ladolexxenti.
English: Why is Intuniv approved?
Maltese: Għaliex ġie approvat Intuniv?
English: Other information about Intuniv
Maltese: Informazzjoni oħra dwar Intuniv
English: The CHMP has recommended several measures, including regular monitoring to manage these risks.
Maltese: Is-CHMP irrakkomanda diversi miżuri, inkluż sorveljanza regolari biex jiġu ġestiti dawn ir-riskji.
English: The active substance in Intuniv is guanfacine.
Maltese: Is-sustanza attiva f'Intuniv hija gwanfaċina.
English: In a long-term maintenance study in 301 children and adolescents aged 6 to 17 years treatment failures occurred in 49% of patients taking Intuniv compared with 65% of those taking placebo.
Maltese: Fi studju ta' manteniment fit-tul f'301 tifel u tifla u adoloxxenti li kellhom bejn 6 u 17-il sena, il-falliment tal-kura seħħew f'49% tal-pazjenti li kienu qed jieħdu Intuniv meta mqabbel ma' 65% ta' dawk li kienu qed jieħdu plaċebo.
English: Intuniv is used to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when stimulant medicines are not appropriate or do not control their symptoms well enough.
Maltese: Intuniv jintuża fil-kura tad-disturb ta' nuqqas ta' attenzjoni u iperattività (attention deficit hyperactivity disorder(ADHD) fi tfal u adoloxxenti li jkollhom bejn 6 u 17-il sena li l-mediċini stimulanti mhumiex adattati għalihom jew ma jikkontrollawx is-sintomi tagħhom tajjeb biżżejjed.
English: In another study of 312 adolescents aged 13 to 17, the reduction in ADHD scores at 13 weeks was 25 points with Intuniv and 19 points with placebo.
Maltese: Fi studju ieħor ta' 312-il adoloxxent li kellhom bejn 13 u 17-il sena, it-tnaqqis fil-punteġġi tal-ADHD wara 13-il ġimgħa kien ta' 25 punt b'Intuniv u 19-il punt bi plaċebo.
English: What are the risks associated with Intuniv?
Maltese: X'inhuma r-riskji assoċjati ma' Intuniv?
English: The most important safety risks are slow heart rate, low blood pressure, fainting, sleepiness and sedation.
Maltese: L-aktar riskji ta' sigurtà importanti huma qalb tħabbat bil-mod, pressjoni tad-demm baxxa, ħass ħażin, ngħas u sedazzjoni.
English: More serious side effects are less common and include: low blood pressure and weight gain (both in around 1 patient in 30), slow heart rate (1 in 60) and fainting (in less than 1 in 100).
Maltese: Effetti sekondarji aktar serji huma anqas komuni u jinkludu: pressjoni tad-demm baxxa u żieda fil-piż (it-tnejn f'madwar pazjent 1 minn kull 30), qalb tħabbat bil-mod (1 minn kull 60) u ħass ħażin (f'anqas minn 1 minn kull 100).
English: It is thought that the active substance, guanfacine, might influence the way signals are transmitted between cells in areas of the brain called the prefrontal cortex and basal ganglia by attaching to certain receptors that are heavily concentrated in these areas.
Maltese: Huwa maħsub li s-sustanza attiva, gwanfaċina, tista' taffettwa l-mod ta' kif is-sinjali jiġu trażmessi bejn iċ-ċelloli f'żoni differenti tal-moħħ imsejħa lkortiċi prefrontali u l-gangliji tal-bażi billi jeħel ma' ċerti riċetturi li huma kkonċentrati ħafna f'dawn iżżoni.
English: The education material should include information on side effects, a checklist to identify children at risk, and a checklist and chart for monitoring children during treatment.
Maltese: Il-materjal edukattiv għandu jinkludi informazzjoni dwar l-effetti sekondarji, lista ta' verifika biex tidentifika tfal f'riskju, u lista ta' verifika u tabella għas-sorveljanza tat-tfal waqt il-kura.
English: The CHMP therefore concluded that the benefits of Intuniv outweigh the risks recommended that it be approved for authorisation in the EU.
Maltese: Il-Kumitat għalhekk ikkonkluda li l-benefiċċji ta' Intuniv huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Intuniv was also evaluated in terms of treatment failures (based either on worsening of ADHD symptoms or patients stopping treatment).
Maltese: Intuniv ġie evalwat ukoll f'termini ta' fallimenti tal-kura (fuq bażi ta' aggravar tas-sintomi tal-ADHD jew pazjenti li jwaqqfu l-kura).
English: The most common side effects with Intuniv are sleepiness (in nearly half of all patients), headache (in more than a quarter), tiredness (in about 1 patient in 5), and upper abdominal pain and sedation (both in around 1 in 10).
Maltese: L-effetti sekondarji l-aktar komuni b'Intuniv huma ngħas (fi kważi nofs il-pazjenti kollha), uġigħ ta' ras (f'aktar minn kwart minnhom), għeja (f'madwar pazjent 1 minn kull 5), u wġigħ fl-addome ta' fuq u sedazzjoni (it-tnejn f'madwar 1 minn kull 10).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that stimulant medicines are first line treatments for ADHD and that these medicines provide a larger and more consistent improvement in ADHD symptoms as part of a comprehensive treatment programme.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija nnota li l-mediċini stimulanti huma kuri tal-ewwel linja għal ADHD u li dawn il-mediċini jipprovdu titjib akbar u aktar konsistenti fis-sintomi tal-ADHD bħala parti minn programm ta' kura komprensiva.
English: Two other short-term studies involving 631 patients also showed Intuniv at various doses improving ADHD scores more than placebo.
Maltese: Żewġ studji oħrajn fil-qosor li involvew 631 pazjent ukoll urew li Intuniv f'diversi dożi jtejjeb il-punteġġi tal-ADHD aktar minn plaċebo.
English: What measures are being taken to ensure the safe and effective use of Intuniv?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Intuniv?
English: • carbamazepine, phenobarbital and phenytoin (medicines for epilepsy);
Maltese: • carbamazepine, phenobarbital u phenytoin (mediċini għall-epilessija);
English: The full EPAR and risk management plan summary for Harvoni 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: Harvoni is available as tablets which contain 90 mg ledipasvir and 400 mg sofosbuvir.
Maltese: Harvoni jiġi bħala pilloli li fihom 90 mg ledipasvir u 400 mg sofosbuvir.
English: Sofosbuvir blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase', while ledipasvir targets a protein called ‘NS5A'.
Maltese: Is-sofosbuvir timblokka l-azzjoni ta' proteina msejħa ‘polimerażi RNA dipendenti fuq NS5B-RNA', filwaqt li l-ledipasvir tpoġġi fil-mira tagħha proteina msejħa ‘NS5A'.
English: This is a summary of the European public assessment report (EPAR) for Harvoni.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Harvoni.
English: Other information about Harvoni
Maltese: Informazzjoni oħra dwar Harvoni
English: Why is Harvoni approved?
Maltese: Għaliex ġie approvat Harvoni?
English: Sofosbuvir has been authorised as Sovaldi since January 2014.
Maltese: Is-sofosbuvir ilu awtorizzat bħala Sovaldi minn Jannar 2014.
English: Harvoni has been investigated in three main studies involving a total of around 2,000 adult patients infected with hepatitis C of genotype 1 whose liver function was normal.
Maltese: Harvoni ġie investigat fi tliet studji ewlenin li involvew total ta' madwar 2,000 pazjent adult infettati blepatite Ċ tal-ġenotip 1 li l-funzjoni tal-fwied tagħhom kienet waħda normali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Harvoni on 17 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Harvoni fis-17 ta' Novembru 2014.
English: Results in children aged below 12 years are not yet available.
Maltese: Riżultati ta' tfal li għandhom inqas minn 12-il sena għad mhumiex disponibbli.
English: Harvoni must not be used together with the cholesterol medicine rosuvastatin.
Maltese: Harvoni m'għandux jintuża flimkien mal-mediċina kontra l-kolesterol rosuvastatin.
English: Harvoni contains the active substances ledipasvir and sofosbuvir.
Maltese: Harvoni fih is-sustanzi attivi ledipasvir u sofosbuvir.
English: What are the risks associated with Harvoni?
Maltese: X'inhuma r-riskji assoċjati ma' Harvoni?
English: Harvoni is an antiviral medicine used to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Maltese: Harvoni huwa mediċina antivirali użata biex tikkura adulti u tfal minn 12-il sena 'l fuq b'epatite Ċ kronika (fit-tul) marda infettiva li taffettwa l-fwied, ikkawżata mill-virus tal-epatite Ċ.
English: The active substances in Harvoni, ledipasvir and sofosbuvir, block two proteins essential for the hepatitis C virus to multiply.
Maltese: Is-sustanzi attivi f'Harvoni, il-ledipasvir u s-sofosbuvir, jimblokkaw żewġ proteini essenzjali sabiex jimmultiplika l-virus tal-epatite Ċ.
English: • St John's wort (a herbal preparation used to treat depression and anxiety).
Maltese: • Fexfiex tar-raba' (St John's wort) (preparazzjoni erbali għall-kura tad-dipressjoni u tal-ansjetà).
English: Around 94% to up to 99% of patients given Harvoni alone had no sign of the virus 12 weeks after the end of treatment.
Maltese: Madwar 94% sa 99% tal-pazjenti li ngħataw Harvoni waħdu ma kellhom ebda sinjal tal-virus 12-il ġimgħa wara t-tmiem tal-kura.
English: Harvoni is also being investigated in a study in children aged 3 to 18 years infected with hepatitis C. Results from 100 patients aged 12 to 18 years (all of whom had hepatitis C genotype 1) showed that 98% of them had no sign of the virus 12 weeks after the end of treatment.
Maltese: Ir-riżultati minn 100 pazjent li għandhom bejn 12 u 18-il sena (li kollha kellhom l-epatite Ċ tal-ġenotip 1) wrew li 98% minnhom ma kellhom ebda sinjal tal-virus 12-il ġimgħa wara t-tmiem talkura.
English: For the full list of all side effects and restrictions with Harvoni, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Harvoni, ara l-fuljett ta' tagħrif.
English: How does Harvoni work?
Maltese: Kif jintuża Harvoni?
English: Patients whose infection was resistant to other antiviral medicines could also benefit from extending treatment to 24 weeks.
Maltese: Pazjenti li kellhom infezzjoni reżistenti għal mediċini antivirali oħrajn setgħu jibbenefikaw ukoll minn kura estiża għal 24 ġimgħa.
English: The company that markets Harvoni will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Harvoni.
Maltese: Il-kumpanija li tqiegħed Harvoni fis-suq se twettaq studju fuq pazjenti li preċedentement kellhom kanċer fil-fwied sabiex tevalwa r-riskju li jirritorna l-kanċer tal-fwied wara kura b'antivirali b'azzjoni diretta bħal Harvoni.
English: By blocking these proteins, Harvoni stops the hepatitis C virus from multiplying and infecting new cells.
Maltese: Billi jimblokka dawn il-proteini, Harvoni jwaqqaf il-virus tal-epatite Ċ milli jimmultiplika u jinfetta ċelluli ġodda.
English: There are several varieties (called genotypes) of hepatitis C virus and Harvoni is recommended for use in patients with virus of genotypes 1, 4, 5 and 6 and for some patients with genotype 3.
Maltese: Hemm diversi varjetajiet (imsejħin ġenotipi) tal-virus tal-epatite Ċ u Harvoni huwa rrakkomandat għall-użu f'pazjenti b'virus tal-ġenotipi 1, 4, 5 u 6, u għal xi pazjenti bilġenotip 3. It-tul tal-kura b'Harvoni u jekk jintużax waħdu jew f'kombinazzjoni ma' mediċina oħra msejħa ribavirin jiddependu mill-ġenotip tal-virus u n-natura tal-problemi tal-fwied li għandhom ilpazjenti, pereżempju jekk għandhom ċirrożi (ċikatriċi) tal-fwied jew jekk il-fwied tagħhom mhux qiegħed jaħdem sew.
English: The duration of treatment with Harvoni and whether it is used alone or in combination with another medicine called ribavirin depends on the genotype of the virus and the nature of the liver problems patients have, for example if they have liver cirrhosis (scarring) or their liver is not working properly.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġew inklużi wkoll irrakkomandazzjonijiet u l-prekawzjonijiet li għandhom ikunu segwiti mill-professjonisti fil-qasam talkura tas-saħħa u mill-pazjenti għall-użu sigur u effettiv ta' Harvoni.
English: Benefit of Harvoni was also shown for patients with genotype 4, 5 and 6, for those with decompensated cirrhosis (when the liver does not work adequately) and for those who had received a liver transplant.
Maltese: Intwera wkoll benefiċċju ta' Harvoni għal pazjenti bil-ġenotip 4, 5 u 6, għal dawk biċ-ċirrożi dekumpensata (meta l-fwied ma jkunx jaħdem b'mod adegwat) u għal dawk li kellhom trapjant talfwied.
English: 1 ml (20 mg/ml) 10 pre-filled syringes
Maltese: 1 mL (20 mg/mL) 10 siringi mimlija għal-lest
English: 2.5 mg Solution for injection
Maltese: 2.5 mg Soluzzjoni għallinjezzjoni
English: 18 August 2011 EMA/685524/2011 EMEA/H/C/002366
Maltese: EMA/773581/2011 EMEA/H/C/002366
English: The active substance in Ibandronic Acid Hexal and Bondronat, ibandronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Ibandronic Acid Hexal u Bondronat, l-aċidu ibandroniku, hija bisfosfonat.
English: What is Ibandronic Acid Hexal?
Maltese: X'hinu Ibandronic Acid Hexal?
English: Ibandronic Acid Hexal was developed as a ‘generic medicine'.
Maltese: Ibandronic Acid Hexal ġie żviluppat bħala ‘mediċina ġenerika'.