FrancophonIA/ELRC3.0 huggingface dataset:
English: The AUC of lacosamide was increased by approximately 30% in mildly and moderately and 60% in severely renal impaired patients and patients with end-stage renal disease requiring haemodialysis compared to healthy subjects, whereas Cmax was unaffected.
Maltese: L'AUC ta' lacosamide żdiedet b'madwar 30% f'pazjenti b'indeboliment renali baxx u moderat u 60% f'pazjenti b'indeboliment renali sever u f'pazjenti b'mard renali fl-istadji tal-aħħar fejn hemm bżonn ta' emodijaliżi, meta mqabbel ma' pazjenti f'saħħithom, iżda Cmax ma ġiex affettwat.
English: Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks.
Maltese: Lacosamide għandu jingħata lil pazjenti adulti u pedjatriċi b'indeboliment t sever talfwied meta l-benefiċċji terapewtiċi mistennija huma akbar mir-riskji possibbli.
English: Uncommon: may affect up to 1 in 100 children Feeling sleepy or lacking in energy (lethargy).
Maltese: Mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 tifel jew tifla Iħossuhom bi ngħas jew b'nuqqas ta' enerġija (letarġija).
English: Lacosamide Accord 200 mg film-coated tablets
Maltese: Lacosamide Accord 200 mg pilloli miksija b'rita
English: 1 film-coated tablet contains 150 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide Accord150 mg fiha 150 mg lacosamide.
English: Lacosamide Accord 150 mg film-coated tablets
Maltese: Lacosamide Accord 150 mg pilloli miksija b'rita
English: Diplopia Vision blurred
Maltese: .8 Effetti mhux mixtieqa
English: Uncommon: may affect up to 1 in 100 children
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna 1 minn 100
English: Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting).
Maltese: Il-pazjenti jridu jkunu mgħarrfa dwar is-sintomi ta' arritmija kardijaka (pereżempju polz baxx, mgħaġġel jew irregulari, palpitazzjonijiet, qtugħ ta' nifs, tħossok sturdut, ħass ħazin).
English: NAME OF THE MEDICINAL PRODUCT Lacosamide Accord 100 mg film-coated tablets lacosamide
Maltese: IL-PRODOTT MEDIĊINALI Lacosamide Accord 100 mg pilloli miksija b'rita lacosamide
English: Common: may affect up to 1 in 10 people
Maltese: Ir-rata ta' twaqqif minħabba reazzjonijiet avversi kien 10.
English: Following a 4-hour haemodialysis treatment, AUC of lacosamide is reduced by approximately 50 %.
Maltese: Wara trattament t'emodijaliżi ta' 4 sigħat, AUC ta' lacosamide kien mnaqqas b' madwar 50%.
English: Sleepiness, tiredness or weakness (asthenia);
Maltese: • Irritibiltà, tbagħti biex torqod, depressjoni;
English: --P1 Live gEP-P tkP-P double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL: 10P6.3P - 10P7.3P CCIDR50 Rper 2 ml (gEP-P: deleted glycoprotein E; tkP-P: deleted thymidine kinase; CCID: cell culture infectious dose)
Maltese: --P1 PVirus tal-Ħerpes tal-Bovini ħaj tip 1 (BoHV-1) gEP-P tkP-P bil-ġene mneħħi darbtejn, speċi CEDDEL: 10P6.3P - 10P7.3P CCIDR50
English: Lyophilisate: 1 bottle
Maltese: 1 flixkun
English: Target species
Maltese: Daqs talpakkett
English: Lyophilisate: bottle (type I glass); solvent: bottle (type I glass or PET)
Maltese: -P: thymidine kinase mneħħi;CCID: cell culture infectious dose (doża infettuża ta' kultura ta' ċelloli))
English: EU (MA) Number
Maltese: R. (2 ml)
English: Invented Name
Maltese: Kontenut
English: EMA/263379/2014 EMEA/V/C/002759
Maltese: EMEA/V/C/002759
English: The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100%, for parainfluenza virus 73 to 97%, for leptospira 59 to 96% and for rabies virus 86 to 100%.
Maltese: Ilperċentwal ta' klieb b'livelli protettivi ta' antikorpi għal parvovirus varja bejn 73 u 100%, għall-virus tal-parainfluwenza 73 u 97%, għal leptospira 59 u 96% u għall-virus tar-rabja 86 u 100%.
English: This summary was last updated in March 2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Marzu 2015.
English: The effectiveness of Versican Plus DHPPi/L4R was initially investigated in a field study involving 129 dogs.
Maltese: L-effikaċja ta' Versican Plus DHPPi/L4R ġiet investigata fi studju li involva 129 kelb.
English: • canine parainfluenza virus, the cause of kennel cough;
Maltese: • il-virus tal-parainfluwenza tal-klieb, li jikkawża l-"kennel cough";
English: Canine distemper, adenovirus, parvovirus, parainfluenza virus (live attenuated), canine leptospirosis, rabies (inactivated) vaccine
Maltese: Distemper tal-klieb, adenovirus, parvovirus, virus tal-parainfluenza (ħaj attenwat), leptospirożi tal-klieb, vaċċin tar-rabja tal-klieb (inattivat)
English: Versican Plus DHPPi/L4R is available as a lyophilisate (freeze-dried pellet) with solvent for injection.
Maltese: Versican Plus DHPPi/L4R huwa disponibbli bħala lijofilizzat (freeze-dried pellet) b'solvent għal injezzjoni.
English: Versican Plus DHPPi/L4R is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria and rabies virus.
Maltese: Versican Plus DHPPi/L4R huwa vaċċin veterinarju li fih il-virus ħaj attenwat (dgħajjef) distemper talklieb, adenovirus tal-klieb tat-tip 2, parvovirus tal-klieb tat-tip 2b u l-virus parainfluenza tal-klieb tattip 2 kif ukoll razez ta' batterji ta' Leptospira u virusijiet tar-rabja tal-klieb inattivati (maqtula).
English: It is typically transmitted through bites of infected animals.
Maltese: Normalment tiġi trażmessa minn gdim ta' annimali infettati.
English: • leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation);
Maltese: • il-leptospirożi, marda batterjali li tista' tiġi trażmessa minn urina infettata u tirriżulta fi fsad, epatite (infjammazzjoni tal-fwied) u suffejra jew nefrite (infjammazzjoni tal-kliewi);
English: Laboratory studies were conducted subsequently to determine the period of protection against distemper, canine adenovirus (type 1 and 2) and parvovirus.
Maltese: L-istudji fil-laboratorju saru biex ikun determinat il-perjodu ta' protezzjoni kontra d-distemper, ladenovirus tal-klieb (tat-tip 1 u 2) u l-parvovirus.
English: This will help protect them against distemper, adenovirus, parvovirosis, kennel cough, leptospirosis and rabies.
Maltese: Dan jgħin jipproteġihom kontra d-distemper, ladenovirus, il-parvovirus, il-‘kennel cough', il-leptospirożi u r-rabja tal-klieb.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi/L4R is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Maltese: L-effett sekondarju l-aktar komuni (deher f'iktar minn 1 minn kull 100 kelb) b'Versican Plus DHPPi/L4R huwa nefħa għal ftit ħin sa 5 cm li tista' tifforma fis-sit tal-injezzjoni wara t-tilqim.
English: Versican Plus DHPPi/L4R is a vaccine.
Maltese: Versican Plus DHPPi/L4R huwa vaċċin.
English: The canine distemper virus, canine adenovirus, canine parvovirus and canine parainfluenza virus in Versican Plus DHPPi/L4R are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria and rabies virus.
Maltese: Il-virus tad-distemper tal-klieb, ladenovirus tal-klieb, il-parvovirus tal-klieb u l-virus tal-parainfluwenza tal-klieb f'Versican Plus DHPPi/L4R huma ħajjin iżda ġew attenwati (imdgħajfa) biex ma jikkawżawx mard; huma kkombinati b'tipi ta' batterji ta' Leptospira u l-virus tar-rabja tal-klieb (inattivati).
English: Versican Plus DHPPi/L4R contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Maltese: Versican Plus DHPPi/L4R fih aġġuvant (idrossidu tal-aluminju) biex itejjeb ir-rispons immunitarju.
English: • canine distemper, an infectious disease which is sometimes called hard pad since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting and diarrhoea, excessive salivation and in some cases fits;
Maltese: • distemper tal-klieb, marda infettiva xi drabi msejħa ‘hard pad' minħabba li l-klieb jistgħu jiżviluppaw tħaxxin tal-ġilda fuq il-pads tas-saqajn, kif ukoll imnieħer iqattar, sogħla, deni, rimettar u dijarea, salivazzjoni eċċessiva u f'xi każijiet aċċessjonijiet;
English: For revaccination, a single dose of Versican Plus DHPPi/L4R is required every three years for distemper, canine adenovirus (type 1 and 2) and parvovirus.
Maltese: Għall-vaċċinazzjoni mill-ġdid, doża singola ta' Versican Plus DHPPi/L4R hija meħtieġa kull tliet snin għad-distemper, l-adenovirus tal-klieb (tat-tip 1 u 2) u l-parvovirus.
English: What is Versican Plus DHPPi/L4R?
Maltese: X'inhu Versican Plus DHPPi/L4R?
English: Other information about Versican Plus DHPPi/L4R:
Maltese: Tagħrif ieħor dwar Versican Plus DHPPi/L4R:
English: Versican Plus DHPPI/L4R is used to protect dogs against:
Maltese: Versican Plus DHPPi/L4R jintuża biex jipproteġi lill-klieb kontra:
English: • canine parvovirus disease, an infection that may severely affect puppies, resulting in lethargy, fever, vomiting and bloody diarrhoea;
Maltese: • marda tal-parvovirus tal-klieb, infezzjoni li tista' taffettwa severament il-ġriewi, li tirriżulta f'letarġija, deni, rimettar u dijarea mdemmija;
English: Annual revaccination is required for protection against parainfluenza virus, leptospirosis and rabies.
Maltese: Vaċċinazzjoni kull sena hija meħtieġa għall-protezzjoni kontra l-virus tal-parainfluwneza, il-leptospirożi u r-rabja tal-klieb.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4R exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4R be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju(CVMP) ikkonkluda li l-benefiċċji ta' Versican Plus DHPPi/L4 jisbqu r-riskji għal indikazzjonijiet approvati u rrakkomanda li Versican Plus DHPPi/L4 jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is the risk associated with Versican Plus DHPPi/L4R?
Maltese: X'inhu r-riskju assoċjat ma' Versican Plus DHPPi/L4R?
English: • canine adenovirus, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
Maltese: • adenovirus tal-klieb tat-tip 1, li jikkawża infezzjoni akuta fil-fwied li tista' toħloq sinjali ta' suffejra (sfurija tal-ġilda u l-għajnejn);
English: • rabies, a viral zoonotic (communicable to man) disease that affects the central nervous system (brain and spinal cord), leading to death.
Maltese: • ir-rabja, marda virali żoonotika (li tittieħed mill-bniedem) li taffettwa s-sistema nervuża ċentrali (moħħ u sinsla tad-dahar), li twassal għal mewt.
English: Other information about Trudexa:
Maltese: Informazzjoni oħra dwar Trudexa:
English: Medicinal Product no longer authorise©EMEA 2007
Maltese: Prodott mediċinali li m'għadux awtorizza©EMEA 2007
English: This summary was last updated in 03-2007.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 03-2007.
English: Trudexa is an anti-inflammatory medicine.
Maltese: Trudexa hu prodott mediċinali anti-inflammatorju.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRUDEXA EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) TRUDEXA Sommarju ta' l-EPAR għall-pubbliku
English: The active substance in Trudexa, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Trudexa, adalimumab, hi antikorp monoklonali.
English: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Maltese: • artrite rewmatika (marda tas-sistema immunoloġika li tikkawża infjammazzjoni tal-ġogi).
English: In the patients who had not taken methotrexate before, more patients taking Trudexa and methotrexate had a 50% reduction in symptoms than those taking methotrexate alone over a year of treatment (62% and 46%, respectively).
Maltese: Filpazjenti li ma kinux ħadu methotrexate qabel, iktar pazjenti li kienu qed jieħdu Trudexa u methotrexate flimkien kellhom tnaqqis ta' 50% fis-sintomi milli dawk li kienu qed jieħdu methotrexate biss matul sena ta' trattament (62% u 46% rispettivament).
English: Trudexa has been studied in five studies including almost 2,900 patients with moderate to severe rheumatoid arthritis.
Maltese: Trudexa ġie studjat f'ħames studji li fihom ħadu sehem 2,900 pazjent bl-artrite rewmatika moderata jew severa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trudexa to Abbott Laboratories Ltd. on 1 September 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Trudexa lil Abbott Laboratories Ltd. nhar l-1 ta' Settembru 2003.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Trudexa's benefits are greater than its risks for treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults when other treatments have been inadequate.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Trudexa jisbqu r-riskji fit-trattament ta' l-artrite psorjatika, spondilite ankilotika u artrite rewmatika moderata jew severa fl-adulti fil-każ meta t-trattamenti l-oħra jkunu adegwati.
English: Trudexa is a medicine containing the active substance adalimumab.
Maltese: Trudexa hu mediċina li fiha s-sustanza attiva adalimunab.
English: What is the risk associated with Trudexa?
Maltese: X'inhuma r-riskji asssoċjati ma' Trudexa?
English: Due to an increased risk of infection, patients must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment with Trudexa.
Maltese: Minħabba t-tnaqqis fir-riskju ta' infezzjoni, il-pazjenti jridu jiġu sorveljati strettament għal infezzjonijiet fosthom it-tuberkulożi, matul u sa 5 xhur wara t-trattament b'Trudexa.
English: In four of these studies (involving over 2,000 patients), the effectiveness of Trudexa, alone or as an as add-on to other anti-inflammatory medicines, including methotrexate, was compared with that of a placebo (a dummy treatment) in patients who generally had taken anti-arthritis medicines in the past.
Maltese: F'erbgħa minn dawn l-istudji (bis-sehem ta' 2,000 pazjent), l-effikaċja ta' Trudexa, waħdu jew flimkien ma' mediċini anti-inflammatorji oħra, inkluż methotrexate, tqabblet ma' dik ta' plaċebo (trattament finta) f'pazjenti li ġeneralment kienu ħadu mediċini ta' kontra l-artrite fl-imgħoddi.
English: Why has Trudexa been approved?
Maltese: Għaliex ġie approvat Trudexa?
English: By blocking TNF, adalimumab improves the inflammation and other symptoms of the diseases.
Maltese: Bl-imblukkar ta' TNF, adalimumab itejjeb l-infjammazzjoni u s-sintomi l-oħra tal-mardiet.
English: In studies of Trudexa, the most common side effects (seen in more than 1 patient in 10) were upper respiratory infection (colds) and injection site reactions (including pain, swelling, redness or pruritus [itching]).
Maltese: Fl-istudji dwar Trudexa, l-iktar effetti sekondarji komuni (li dehru f'iktar minn pazjent wieħed minn kull 10) kienu l-infezzjonijiet respiratorji (irjiħat) u reazzjonijiet fis-sit ta' l-injezzjoni (inkluż uġigħ, nefħa, ħmura jew ħakk).
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in the body.
Maltese: Antikorp monoklonali hu antikorp (tip ta' proteina) li jkun ġie ddisinjat biex jagħraf u jeħel ma' struttura speċifika (magħrufa bħala antiġen) li tinstab fil-ġisem.
English: In rheumatoid arthritis, Trudexa was more effective than placebo in reducing symptoms.
Maltese: Fl-artrite rewmatika, Trudexa kien iktar effettiv mill-plaċebo fit-tnaqqis tas-sintomi.
English: What is Trudexa?
Maltese: X'inhu Trudexa?
English: The medicines were taken alone or in combination with another anti-inflammatory medicine such as methotrexate.
Maltese: Il-mediċini ttieħdu weħidhom jew flimkien ma' mediċini anti-inflammatorji oħra bħal methotrexate.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) in patients who have not responded adequately to other treatments,
Maltese: • artrite psorjatika (marda li tikkawża rqajja' ħomor, bil-qxur fuq il-ġilda u infjammazzjoni talġogi) f'pazjenti li ma jkunux wieġbu b'mod adegwat għal trattamenti oħra,
English: The greatest reductions were seen in the studies examining Trudexa as an add-on to methotrexate: in the two studies taken together, around two thirds of the patients adding 40 mg Trudexa every 2 weeks had at least a 20% reduction in symptoms after 6 months, compared to a quarter of those adding placebo.
Maltese: L-ikbar tnaqqis deher fl-istudji li eżaminaw Trudexa meta miżjud ma' methotrexate: fiż-żewġ studji meħudin flimkien, madwar żewġ terzi tal-pazjenti li żdidulhom 40 mg ta' Trudexa kull ġimagħtejn kellhom tnaqqis fis-sintomi ta' mill-inqas 20% wara 6 xhur, meta mqabbla ma' kwart minn dawk li żdidilhom il-plaċebo.
English: How does Trudexa work?
Maltese: Għal xiex jintuża Trudexa?
English: • severe ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) in patients who have not responded adequately to other treatments.
Maltese: • spondilite ankilotika (marda li tikkawża infjammazzjoni u uġigħ fil-ġogi tas-sinsla tad-dahar) f'pazjenti li ma jkunux wieġbu b'mod adegwat għal trattamenti oħra.
English: For ankylosing spondylitis, Trudexa and placebo as an add-on to existing treatment were compared in two studies involving 397 patients.
Maltese: Fil-ħames studji kollha, il-kejl ewlieni ta' l-effikaċja kien it-tibdil fis-sintomi wara trattament ta' bejn 6 xhur u sena.
English: The fifth study included 799 patients, none of whom had taken methotrexate in the past, and compared the combination of Trudexa and methotrexate to methotrexate or Trudexa alone.
Maltese: Ilħames studju kien fih 799 pazjent, li l-ebda wieħed minnhom ma kien ħa methotrexate fl-imgħoddi, u qabbel il-kombinazzjoni ta' Trudexa u methotrexate ma' Trudexa jew methotrexate waħdu.
English: How has Trudexa been studied?
Maltese: Kif ġie studjat Trudexa?
English: Adalimumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor (TNF).
Maltese: magħruf bħala fattur tan-nekrożi minn tumur (TNF).
English: The full EPAR for Tybost 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: Tybost is available as tablets (150 mg).
Maltese: Tybost huwa disponibbli bħala pilloli (150 mg).
English: Tybost was shown to be as effective as ritonavir: around 85% of patients (293 out of 344 patients) given Tybost responded to treatment, compared with around 87% of patients (304 out of 348 patients) given ritonavir.
Maltese: Tybost intwera li huwa effikaċi daqs ritonavar: madwar 85 % tal-pazjenti (293 minn 344 pazjent) li ngħataw Tybost irrispondew għall-kura, meta mqabbel ma' madwar 87 % tal-pazjenti (304 minn 348 pazjent) li ngħataw ritonavir.
English: This is a summary of the European public assessment report (EPAR) for Tybost.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Tybost.
English: Other information about Tybost
Maltese: Informazzjoni oħra dwar Tybost
English: Tybost must not be taken together with a number of other medicines that affect the way Tybost is broken down or whose action is affected by Tybost: alfuzosin (used to treat an enlarged prostate gland); amiodarone or quinidine (used to correct irregular heartbeat); carbamazepine, phenobarbital, or phenytoin (used to prevent seizures); rifampicin (used to prevent and treat tuberculosis and other infections); dihydroergotamine, ergometrine or ergotamine (used to treat migraine headache); cisapride (used to relieve certain stomach problems); St. John's wort (a herbal remedy used for depression and anxiety); lovastatin or simvastatin (used to lower blood cholesterol); pimozide (used to treat abnormal thoughts or feelings); sildenafil (used to treat pulmonary arterial hypertension); and oral midazolam or triazolam (used to aid sleep or relieve anxiety).
Maltese: Tybost ma għandux jittieħed flimkien ma' għadd ta' mediċini oħra li jaffettwaw il-mod li bih jitkisser Tybost jew l-azzjoni tiegħu hija affettwata minn Tybost: alfuzosin (użat biex jikkura glandola talprostata mkabbra); amiodarone jew quinidine (użati biex jikkoreġu t-taħbit irregolari tal-qalb); carbamazepine, phenobarbital jew phenytoin (użati biex jipprevjenu l-aċċessjonijiet); rifampicin (użat biex jipprevjeni u jikkura t-tuberkulożi u infezzjonijiet oħra); dihydroergotamine, ergometrine jew ergotamine (jintużaw biex jikkuraw l-emigranja); cisapride (użat biex itaffi ċerti problemi fl-istonku);
English: This summary was last updated in 09-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar f'09-2013.
English: Tybost was compared with another medicine called ritonavir in one main study involving 698 patients infected with HIV-1.
Maltese: Tybost tqabbel ma' mediċina oħra msejħa ritonavir fi studju ewlieni wieħed li involva 698 pazjent infettat bl-HIV-1.
English: It is used in the treatment of adults infected with HIV-1, a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Tintuża fil-kura tal-adulti infettati bl-HIV-1, vajrus li jikkawża sindromu minn immunodefiċjenza akkwiżita (AIDS).
English: Why is Tybost approved?
Maltese: Għal xiex ġiet approvat Tybost?
English: Tybost is a medicine that contains the active substance cobicistat.
Maltese: Tybost huwa mediċina li fiha s-sustanza attiva kobikistat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tybost on 19 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tybost fid-19 ta' Settembru 2013.
English: The active substance in Tybost, cobicistat, blocks the action of a group of liver enzymes called CYP3A, which are involved in breaking down medicines in the body.
Maltese: Is-sustanza attiva f'Tybost, il-kobikistat, timblokka l-azzjoni ta' grupp ta' enzimi tal-fwied imsejħin CYP3A, li huma involuti fit-tkissir tal-mediċini fil-ġisem.
English: Tybost is taken with atazanavir or darunavir, both of which are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of the HIV-1 virus.
Maltese: Tybost jittieħed ma' atazanavir u darunavir, li t-tnejn huma inibituri ta' protease: jimblokkaw enzima msejħa protease li hija involuta fir-riproduzzjoni tal-vajrus HIV-1.
English: Tybost is given together with 300 mg atazanavir once per day or with 800 mg darunavir once per day.
Maltese: Tybost jingħata flimkien ma' atazanavir tat-300 mg darba kuljum jew ma' darunavair tat-800 mg darba kuljum.
English: A risk management plan has been developed to ensure that Tybost is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Tybost jintuża bl-aktar mod sigur possibbli.
English: What measures are being taken to ensure the safe and effective use of Tybost?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Tybost?
English: Studies showed that Tybost was as effective as ritonavir as a booster for atazanavir, and a similar effect is expected for darunavir based on data on the impact of Tybost on the darunavir levels in the body.
Maltese: Studji wrew li Tybost kien effikaċji daqs ritonavir bħala rinforz għal atazanavir, u hu mistenni effett simili għal darunavir abbażi tad-dejta dwar l-impatt ta' Tybost fuq il-livelli ta' darunavir fil-ġisem.
English: What are the risks associated with Tybost?
Maltese: X'inhuma r-riskji assoċjati ma' Tybost?