FrancophonIA/ELRC3.0 huggingface dataset:
English: Valsartan was as effective as captopril in reducing all-cause mortality after myocardial infarction.
Maltese: Valsartan kien effettiv daqs captopril biex inaqqas il-mortalità minn kull kawża wara infart mijokardijaku.
English: Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Maltese: Valsartan mhux magħruf li jeħel jew jimblokka riċetturi ta' ormoni oħra jew kanali tal-joni magħrufa li huma importanti fir-regolazzjoni kardjovaskulari.
English: Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Maltese: L-ikel inaqqas l-espożizzjoni (kif imkejjel mill-AUC) għal valsartan b'madwar 40% u l-konċentrazzjoni massima fil-plażma (Cmax) b'madwar 50%, għalkemm minn madwar 8 h wara d-dożaġġ konċentrazzjonijiet ta' valsartan filplażma huma simili għall-gruppi mitmuma u sajma.
English: Slovak Republic Novartis s.r.o.
Maltese: Ir-Repubblika Ċeka ls-Slovakkja
English: Renal failure and impairment
Maltese: Insuffiċjenza u indeboliment renali
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Valsartan
Maltese: Diovan u ismijiet assoċjati miegħu (Ara Anness I) 40 mg pilloli miksija b'rita Valsartan
English: The first area of disagreement is about the use of triple combination (Valsartan + ACEI+ BB) in chronic HF.
Maltese: 4.2 - Pożoloġija u metodu ta' kif għandu jingħata L-ewwel qasam ta' nuqqas ta' ftehim huwa fir-rigward tal-użu ta' kombinazzjoni tripla (Valsartan + ACEI + BB) f'HF kronika.
English: Dizziness, Postural dizziness
Maltese: DATA TA' META JISKADI
English: Diovan works by blocking the effect of angiotensin II.
Maltese: Diovan jaħdem billi jimblokka l-effett ta' angiotensin II.
English: In a subgroup of patients not receiving an ACE inhibitor (n=366), the morbidity benefits were greatest.
Maltese: Il-benefiċċji għall-morbidità kienu l-akbar f'sottogrupp ta' pazjenti li ma kienux qed jirċievu inibitur ta' ACE (n=366).
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1. [Biex timtela mill-pajjiż partikolari]
English: There was no difference in all-cause mortality, cardiovascular mortality or morbidity when beta blockers were administered together with the combination of valsartan + captopril, valsartan alone, or captopril alone.
Maltese: Ma kienx hemm differenza fil-mortalità minn kull kawża, mortalità kardjovaskulari jew morbidità meta imblokkaturi tar-riċetturi beta ingħataw flimkien mat-taħlita ta' valsartan + captopril, valsartan waħdu, jew captopril waħdu.
English: Additional information on special populations
Maltese: Informazzjoni oħra dwar popolazzjonijiet speċjali
English: With reference to the contraindication for the use of Diovan during pregnancy or lactation, the CHMP in line with the recommendations of the Pharmacovigilance experts considered that the contraindication shall be removed and the following recommendation included in the specific section relevant to pregnancy and lactation as follows: “Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
Maltese: B'referenza għall-kontra-indikazzjoni għall-użu ta' Diovan matul it-tqala jew treddigħ, il-CHMP f'konformità mar-rakkomandazzjonijiet tal-esperti talFarmakoviġilanza qies li l-kontra-indikazzjoni għandha titneħħa u r-rakkomandazzjoni li ġejja għandha tiġi inkluża fis-sezzjoni speċifika relevanti għat-tqala u t-treddigħ kif ġej: “Minħabba li ma hemm ebda informazzjoni disponibbli fir-rigward tal-użu ta' valsartan matul it-treddigħ, Diovan (Valsartan) mhuwiex rakkomandat u kura alternattiva bi profili tas-sigurtà stabbilti aħjar matul ittreddigħ huma preferibbli, b'mod speċjali waqt il-kura ta' tarbija tat-twelid jew ta' tarbija li twieldet qabel”.
English: Acknowledging the comments from the CHMP and the Rapporteurs and in the absence of any new data regarding triple therapy with valsartan, the MAH proposed to substitute the wording “the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended” in chronic heart failure as requested in the relevant sections of the SPC (sections 4.2 and 4.4).
Maltese: Wara li għaraf il-kummenti mill-CHMP u mir-Rapporteurs u fin-nuqqas ta' xi dejta ġdida dwar terapija tripla b'valsartan, il-MAH ippropona li jissostitwixxi l-kliem “il-kombinazzjoni tripla ta' inibitur ACE, beta blocker u valsartan mhijiex rakkomandata” f'indeboliment kroniku tal-qalb kif mitlub fis-sezzjonijiet relevanti tal-SPC (sezzjonijiet 4.2 u 4.2).
English: • dizziness, postural dizziness
Maltese: • sturdament, sturdament mal-waqfien
English: Dose adjustment is therefore not required in patients with renal impairment (creatinine clearance >10 ml/min).
Maltese: Għalhekk mhux meħtieġ aġġustament tad-doża f'pazjenti b'indeboliment renali (tneħħija tal-krejatinina >10 ml/min).
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Meta ssir dijanjosi ta' tqala kura b'AIIRAs għandha titwaqqaf minnufih, u jekk xieraq għandha tinbeda terapija alternattiva.
English: --1 Per 1 ml dose: live feline calicivirus (strain F9) 104.6-106.1 CCID50; live feline viral rhinotracheitis virus (strain F2) 105.0-106.6 CCID50 ; live feline panleucopenia virus (strain LR 72) 103.7-104.5 CCID50; and purified p45 FeLV-envelope antigen, minimum quantity 102 μg
Maltese: --1 Għal kull doża ta' 1 ml: kaliċivirus felin haj (razza F9) 104.6 -106.1 CCID50 ; virus rinotrakeite virali Ħaj Felin (razza F2) 105.
English: 150 (3x50) capsules
Maltese: 150 (3x50) kapsula
English: 150 mg Film-coated tablet Oral use
Maltese: 150 mg Kapsula, iebsa Użu orali
English: The full EPAR for Hirobriz Breezhaler 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: The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.
Maltese: Iż-żieda fl-FEV1 kienet 130 ml b'tiotropium, u 80 ml b'formoterol.
English: This summary was last updated in 09-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'09-2017
English: The active substance in Hirobriz Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Maltese: Is-sustanza attiva f'Hirobriz Breezhaler, l-indakaterol, hija agonista tar-riċettur adrenerġiku ta' beta-2.
English: Hirobriz Breezhaler is used for maintenance (regular) treatment.
Maltese: Hirobriz Breezhaler jintuża għall-kura ta' manteniment (regolari).
English: European Commission granted a marketing authorisation valid throughout the European Union for Hirobriz Breezhaler on 30 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Hirobriz Breezhaler fit-30 ta' Novembru 2009.
English: Overall, the effects of the 150 and 300 microgram doses of Hirobriz Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Maltese: B'mod globali, l-effetti tad-dożi ta' 150 u 300 mikrogramma ta' Hirobriz Breezhaler kienu simili, iżda r-riżultati wrew li d-doża ta' 300 mikrogramma tista' tipprovdi solljev aħjar f'pazjenti b'mard iktar serju.
English: Hirobriz Breezhaler indacaterol
Maltese: Hirobriz Breezhaler indakaterol
English: On average, the increase in FEV1 in patients who received Hirobriz Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Maltese: Bħala medja, iż-żieda fl-FEV1 f'pazjenti li rċevew Hirobriz Breezhaler kienet madwar 150 u 190 ml, waqt li għal pazjenti li rċevew il-plaċebo, il-bidla fl-FEV1 varjat minn tnaqqis ta' 10 ml sa żieda ta' 20 ml.
English: In three main studies involving over 4,000 patients with COPD, Hirobriz Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Maltese: Fi tliet studji ewlenin li involvew 'il fuq minn 4,000 pazjent bis-COPD, Hirobriz Breezhaler tqabbel malplaċebo (kura finta), tiotropium jew formoterol (mediċini oħra li jiġu inalati li jintużaw biex jikkuraw isCOPD).
English: This is a summary of the European public assessment report (EPAR) for Hirobriz Breezhaler.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Hirobriz Breezhaler.
English: Other information about Hirobriz Breezhaler
Maltese: Informazzjoni oħra dwar Hirobriz Breezhaler
English: Hirobriz Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Maltese: Hirobriz Breezhaler huwa mediċina li tintuża biex iżżomm il-passaġġi tal-arja miftuħin f'adulti li jbatu b'mard pulmonari ostruttiv kroniku (COPD, chronic obstructive pulmonary disease).
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Maltese: Din taħdem billi teħel ma' riċetturi ta' beta-2 li jinstabu fiċ-ċelloli tal-muskoli ta' ħafna organi u li jġiegħlu lill-muskoli jirrilassaw.
English: The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.
Maltese: It-tabib jista' jżid id-doża għal kapsula waħda ta' 300 mikrogramma darba kuljum f'każi ta' COPD serja.
English: For the full list of all side effects and restrictions with Hirobriz Breezhaler, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Hirobriz Breezhaler, ara l-fuljett ta' tagħrif.
English: The most common side effects with Hirobriz Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Maltese: L-effetti sekondarji l-aktar komuni b'Hirobriz Breezhaler (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn) u infezzjoni fl-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn).
English: Why is Hirobriz Breezhaler approved?
Maltese: Għaliex ġie approvat Hirobriz Breezhaler?
English: What are the risks associated with Hirobriz Breezhaler?
Maltese: X'inhuma r-riskji assoċjati ma' Hirobriz Breezhaler?
English: The Agency also noted that there were no major safety concerns with Hirobriz Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Maltese: L-Aġenzija nnotat ukoll li ma kien hemm l-ebda tħassib maġġuri dwar issigurtà b'Hirobriz Breezhaler, bl-effetti sekondarji jkunu maniġġabbli u simili għal mediċini agonisti tarriċettur adrenerġiku ta' beta-2 oħra.
English: Hirobriz Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Maltese: Hirobriz Breezhaler kien aktar effettiv mill-plaċebo fit-titjib ta' kif jaħdmu l-pulmuni f'pazjenti bisCOPD.
English: Hirobriz Breezhaler capsules, which contain a powder for inhalation, are only used with a Hirobriz Breezhaler inhaler and must not be swallowed.
Maltese: Il-kapsuli ta' Hirobriz Breezhaler, li fihom trab għall-inalazzjoni, jintużaw biss ma' inalatur Hirobriz Breezhaler u m'għandhomx jinbelgħu.
English: How does Hirobriz Breezhaler work?
Maltese: Kif jintuża Hirobriz Breezhaler?
English: How is Hirobriz Breezhaler used?
Maltese: Kif jaħdem Hirobriz Breezhaler?
English: C208 - C216 (QUEST-1 and QUEST-2;
Maltese: C208 - C216 (QUEST-1 u QUEST-2;
English: MARKETING AUTHORISATION HOLDER
Maltese: MARKETING AUTHORISATION
English: Triazolam (oral)
Maltese: Triazolam (orali)
English: OPTIMIST-1 and OPTIMIST-2
Maltese: OPTIMIST-1 u OPTIMIST-2
English: Antiviral activity in vivo
Maltese: Attività antivirali in vivo
English: ANTITUSSIVE Dextromethorphan (DXM)
Maltese: ANTITUSSIV Dextromethorphan (DXM)
English: GLUCOCORTICOIDS Dexamethasone (systemic)
Maltese: GLUCOCORTICOIDS Dexamethasone (sistemika)
English: EU/1/14/924/002 (28 capsules)
Maltese: EU/1/14/924/002 (28 kapsuli)
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin
Maltese: IMPEDITURI TA' HMG-CO-A REDUCTASE Rosuvastatin
English: Study1
Maltese: Studju1
English: HPC2002 (COSMOS; Phase 2)
Maltese: HPC2002 (COSMOS;
English: HCV genotype 4a - 4d
Maltese: HCV ġenotip 4a - 4d
English: ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Maltese: ANTIKONVULANTI Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
English: Magnesium hydroxide Calcium carbonate
Maltese: Aluminium jew Magnesium hydroxide Calcium carbonate
English: ANTIHISTAMINES Astemizole Terfenadine
Maltese: ANTISTAMINI Astemizole Terfenadine
English: Antibiotics - macrolides (systemic administration) Azithromycin
Maltese: Antibijotiċi - makrolidi (amministrazzjoni sistemika) Azithromycin
English: Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Maltese: Kontenut tal-kapsula Sodium lauryl sulfate Magnesium stearate silica anidru kollojdali Croscarmellose sodium Lactose monohydrate
English: Genotype 1 (N = 9) Genotype 2 (N = 6) Genotype 3 (N = 8) Genotype 4 (N = 8) Genotype 5 (N = 7) Genotype 6 (N = 8)
Maltese: Genotip 1 (N = 9) Genotip 2 (N = 6) Genotip 3 (N = 8) Genotip 4 (N = 8) Genotip 5 (N = 7) Genotip 6 (N = 8)
English: Other NRTIs (Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Zidovudine)
Maltese: (Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Zidovudine)
English: INFORMATION IN BRAILLE olysio 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE olysio 150 mg
English: HIV PRODUCTS Antiretroviral - CCR5 antagonist Maraviroc
Maltese: Antiretrovirali - antagonist ta' CCR5 Maraviroc
English: Antiretroviral - protease inhibitors (PIs) Darunavir/ritonavir3
Maltese: Antiretrovirali - impedituri ta' protease (PIs) Darunavir/ritonavir3
English: Disopyramide Flecainide Mexiletine Propafenone Quinidine
Maltese: Mexiletine Propafenone Quinidine
English: Chemistry Amylase
Maltese: Kimika Amylase
English: ULN = Upper Limit of Normal.
Maltese: ULN = (Upper Limit of Normal) Limitu Ogħla tan-Normal.
English: Laboratory parameter
Maltese: Parametru tallaboratorju
English: C206 (ASPIRE; Phase 2)
Maltese: C206 (ASPIRE;
English: H2-receptor antagonists Cimetidine
Maltese: H2-antagonisti tar-riċettatur Cimetidine
English: Study HPC3007
Maltese: Studju HPC3007
English: Antiretroviral - integrase inhibitor Raltegravir
Maltese: Antiretrovirali - impeditur ta' integrase Raltegravir
English: HPC3011 (RESTORE; Phase 3)
Maltese: HPC3011 (RESTORE;
English: - The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
Maltese: - Is-sustanzi l-oħra huma sodium lauryl sulfate, magnesium stearate, silica anidru kollojdal, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) u shellac (E904).
English: Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) Tenofovir disoproxil fumarate
Maltese: Antiretrovirali - impedituri nukleosidi jew nukleotidi ta' reverse transcriptase (N(t)RTIs) Tenofovir disoproxil fumarate
English: Baseline HCV RNA levels > 800,000 IU/ml
Maltese: Livelli ta' RNA ta' HCV > 800,000 IU/ml
English: Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Genotype
Maltese: Tabella 9: Attività antivirali ta' monoterapija b'simeprevir 200 mg (studji C201 u C202)
English: Study HPC2014 N = 43 % (n/N)
Maltese: Studju HPC2014 N = 43 % (n/N)
English: HPC3021 (PLUTO; Phase 3)
Maltese: HPC3021 (PLUTO;
English: HERBAL PRODUCTS Milk thistle (Silybum marianum)
Maltese: Tfief (Silybum marianum)
English: Lipase Grade 1
Maltese: Lipase Grad 1
English: 1 WHO worst toxicity grades 1 to 4.
Maltese: 1 L-agħar tossiċità tal-WHO minn gradi 1 sa 4.
English: Viral breakthrough rates were 24% (11/45), 20% (5/25) and 11% (4/36) in patients with genotype 4a, 4d and 4/other, respectively.
Maltese: Ir-rati ta' progress virali kienu 24% (11/45), 20% (5/25) u 11% (4/36) f'pazjenti b'ġenotip 4a, 4d u
English: IL28B genotype
Maltese: Ġenotip IL28B
English: Simeprevir does not affect CYP2C9, CYP2C19 or CYP2D6 in vivo.
Maltese: Simeprevir ma jaffettwax CYP2C9, CYP2C19 jew CYP2D6 in vivo.
English: 2 Comparison based on historic controls.
Maltese: 2 Tqabbil ibbażżat fuq kontrolli storiċi.
English: Antiretroviral - non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz
Maltese: Antiretrovirali - impedituri mhux nukleosidi ta' reverse transcriptase (NNRTIs - nonnucleoside reverse transcriptase inhibitors) Efavirenz
English: * darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone.
Maltese: * darunavir/ritonavir + 50 mg simeprevir meta mqabbel ma' 150 mg simeprevir waħdu.
English: Other NNRTIs (Delavirdine, Etravirine, Nevirapine)
Maltese: (Delavirdine, Etravirine, Nevirapine)
English: HPC3007 (PROMISE; Phase 3)
Maltese: HPC3007 (PROMISE;
English: Opaque polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PE/PVDC) aluminium push-through blister strips of 7 capsules.
Maltese: Folji opaki tal-polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PR/PVDC) aluminium ta' 7 kapsuli li timbotthom minnhom
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 14 ta' Mejju 2014
English: HPC3017 (OPTIMIST-1; Phase 3)
Maltese: HPC3017 (OPTIMIST-1;
English: HPC3018 (OPTIMIST-2; Phase 3)
Maltese: HPC3018 (OPTIMIST-2;
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/924/001 (7 capsules) EU/1/14/924/002 (28 capsules)
Maltese: NUMBER(S) EU/1/14/924/001 (7 kapsuli) EU/1/14/924/002 (28 kapsuli)
English: HCV genotype 1b
Maltese: HCV ġenotip 1b
English: Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Hispanic
Maltese: Età (snin) medjan (firxa) % akbar minn 65 sena Sess maskili Razza Bojod Suwed/Amerikani Afrikani
English: Genotype 1b
Maltese: Ġenotip 1b
English: 48 weeks3
Maltese: 48 ġimgħa 3
English: Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at time of failure.
Maltese: Nota, sostituzzjonijiet ta' NS3 f'pożizzjoni 43 u 156 assoċjati ma' tnaqqis fl-attività ta' simeprevir in vitro ma ġewx osservati fi żmien ta' falliment.
English: Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Maltese: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Il-Belġju Manifattur
English: Black printing ink Shellac (E904) Iron oxide black (E172)
Maltese: Iron oxide black (E172)
English: Environmental Risk Assessment (ERA) Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Maltese: Simeprevir huwa kklassifikat bħala sustanza PBT (persistenti, bijoakkumulattiv u tossiku) (ara sezzjoni 6.6).
English: Tacrolimus 2 mg patient individualised dose4
Maltese: Tacrolimus 2 mg doża individwalizzata għal pazjent4
English: Simeprevir is extensively bound to plasma proteins (> 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Maltese: Simeprevir jinrabat b'mod estensiv ma' proteini fil-plażma (> 99.9%), prinċipalment mal-albumina u, sa ċertu punt, ma' alfa-1-acid glycoprotein.
English: The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Maltese: Irreazzjonijiet avversi huma elenkati skont il-klassifika tas-sistema tal-organi (SOC - system organ class) u l-frekwenza: (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari
English: 24 weeks N = 31
Maltese: N = 31
English: Oral: 0.075 mg/kg Intravenous:
Maltese: Midazolam Orali: 0.075 mg/kg Ġol-vina 0.025 mg/kg
English: Table 21: SVR12 rates for selected subgroups (study HPC3007) Subgroup simeprevir + peginterferon + ribavirin % (n/N)
Maltese: Rati ta' SVR12 għal sottogruppi magħżula (studju HPC3007) Sottogrupp simeprevir + peginterferon + ribavirin % (n/N)
English: R155Q3, D168A, D168F3, D168H, D168T, I170T5
Maltese: Q80K3, S122A/G/I/T3, S122R, R155Q D168A, D168F3, D168H, D168T, I170T5
English: R155K Q80X+D168X4
Maltese: Q80X+D168X R155X+ D168X4
English: (inhibition of P-gp transporter)
Maltese: (impediment ta' trasportatur ta' P-gp)
English: (study C212)
Maltese: C212
English: Simeprevir does not inhibit OCT2 in vitro.
Maltese: Simeprevir ma jinibixxix OCT2 in vitro.
English: Pack sizes of 7 or 28 capsules.
Maltese: 7 kapsuli ibsin 28 kapsula iebsa
English: All HCV genotypes N = 197 % (n)
Maltese: HCV N = 197 % (n)
English: Capsule shell Gelatin
Maltese: Il-qoxra tal-kapsula Gelatin
English: (OATP1B1/3, P-gp and CYP3A inhibition by ciclosporin)
Maltese: (impediment ta' OATP1B1/3, P-gp u CYP3A b'ciclosporin)
English: 40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑ omeprazole Cmin not studied
Maltese: 40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑
English: > 1.5 to ≤ 3.0 x ULN 22 (7.7%)
Maltese: > 1.5 sa ≤ 3.0 x ULN 22 (7.7%)
English: 10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑ rosuvastatin Cmin not studied
Maltese: 10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑
English: METAVIR fibrosis score
Maltese: Punteġġ ta' fibrożi METAVIR
English: S-warfarin AUC 1.04 (1.00-1.07) ↔ S-warfarin Cmax 1.00 (0.94-1.06) ↔ S-warfarin Cmin not studied
Maltese: S-warfarin AUC 1.04 (1.00-1.07) ↔ S-warfarin Cmax 1.00 (0.94-1.06) ↔
English: 30-150 mg once daily, individualised dose
Maltese: Methadone7 30-150 mg darba kuljum, doża individwalizzata
English: SEDATIVES/ANXIOLYTICS Midazolam
Maltese: SEDATTIVI/ANSJOLITIĊI
English: Proton pump inhibitors Omeprazole
Maltese: Impedituri tal-proton-pump Omeprazole
English: 2 Relapsers after prior interferon-based therapy.
Maltese: 2 Irkadew wara terapija preċedenti abbażi ta' interferon.
English: OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients (see sections 4.2, 4.4 and 5.1).
Maltese: epatite Ċ kronika (CHC) (chronic hepatitis C, CHC) f'pazjenti adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Oral: midazolam AUC 1.45 (1.35-1.57) ↑ midazolam Cmax 1.31 (1.19-1.45) ↑ midazolam Cmin not studied
Maltese: Orali: midazolam AUC 1.45 (1.35-1.57) ↑ midazolam Cmax 1.31 (1.19-1.45) ↑
English: 24 weeks OLYSIO + sofosbuvir or 12 weeks OLYSIO + sofosbuvir + ribavirin2
Maltese: 24 ġimgħa OLYSIO + sofosbuvir jew 12-il ġimgħa OLYSIO + sofosbuvir + ribavirin2
English: 1 Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
Maltese: 1 Rata ta' kontroll superjuri versus dik storika (rati storiċi approvati ta' SVR ta' kombinazzjonijiet approvati ta' trattamenti ta' antivirali li jaħdmu b'mod dirett flimkien ma' peginterferon alfa u ribavirin).
English: 12, 24 or 48 weeks SMV in combination with 48 weeks peg-IFN-alfa + RBV; control group: 48 weeks placebo + peg-IFN-alfa + RBV
Maltese: 12, 24 jew 48 ġimgħa ta' SMV flimkien ma' 48 ġimgħa peg-IFN-alfa + RBV; grupp ta' kontroll: 48 ġimgħa ta' plaċebo + peg-IFN-alfa + RBV
English: (OATP1B1 inhibition by tacrolimus)
Maltese: (impediment ta' OATP1B1 b'tacrolimus)
English: HCV PRODUCTS Antiviral
Maltese: PRODOTTI GĦAL HCV
English: CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine
Maltese: TAL-KANAL TAL-KALĊJU (tingħata mill-ħalq) Amlodipine