FrancophonIA/ELRC3.0 huggingface dataset:
English: Nonafact has been studied in two clinical studies, including 26 patients who received Nonafact as a prevention treatment (for example before extensive exercise), and 8 patients who received Nonafact during 11 surgical interventions.
Maltese: Nonafact ġie studjat f'żewġ studji kliniċi, li inkludew 26 pazjent li rċevew Nonafact bħala kura ta' prevenzjoni (pereżempju qabel eżerċizzju intensiv), u 8 pazjenti li rċevew Nonafact waqt 11-il intervent kirurġiku.
English: Patients with haemophilia B lack factor IX, and this causes bleeding problems, such as bleeding in the joints, muscle or internal organs.
Maltese: Pazjenti bl-emofilija B huma neqsin mill-fattur IX, u dan jikkawża problemi ta' fsada, bħal fsada fil-ġogi, fil-muskoli jew fl-organi interni.
English: Nonafact can be used in adults and children over the age of 6.
Maltese: Nonafact jista' jintuża f'adulti u fi tfal li għandhom iktar minn 6 snin.
English: What is Nonafact?
Maltese: X'inhu Nonafact?
English: Nonafact contains human coagulation factor IX, a protein extracted and purified from human plasma (the liquid part of the blood).
Maltese: Nonafact fih il-fattur IX tal-koagulazzjoni tal-bniedem, proteina meħuda u ppurifikata mill-plażma talbniedem (il-parti likwida tad-demm).
English: Nonafact is given by infusion into a vein at a rate of no more than 2 ml per minute.
Maltese: Nonafact jingħata permezz ta' injezzjoni ġol-vina b'rata ta' mhux iktar minn 2 ml kull minuta.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nonafact on 3 July 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nonafact fit-3 ta' Lulju 2001.
English: Nonafact is a powder and solvent that are mixed together to form a solution for infusion (drip) into a vein.
Maltese: Nonafact huwa disponibbli bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni jew infużjoni (dripp) ġol-vina.
English: Haemophilia B patients may develop antibodies (inhibitors) to factor IX.
Maltese: Sensittività eċċessiva (reazzjonijiet allerġiċi) kultant dehret f'pazjenti kkurati bi prodotti li fihom il-fattur IX.
English: A risk management plan has been developed to ensure that Nonafact is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Nonafact jintuża bl-aktar mod sigur possibbli.
English: The CHMP decided that Nonafact's benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B. They recommended that Nonafact be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Nonafact huma akbar mir-riskji tiegħu għall-kura u l-prevenzjoni tal-fsada f'pazjenti li jbatu minn emofilija B.
English: Why has Nonafact been approved?
Maltese: Għaliex ġie approvat Nonafact?
English: What is the risk associated with Nonafact?
Maltese: X'inhu r-riskju assoċjat ma' Nonafact?
English: Nonafact must not be used in people who are hypersensitive (allergic) to human coagulation factor IX or to any of the other ingredients, or to mouse proteins.
Maltese: Nonafact ma għandux jintuża f'nies li jista' jkollhom sensittività eċċessiva (allerġiċi) għall-fattur IX ta' koagulazzjoni tal-bniedem, għal xi waħda mis-sustanzi l-oħra, jew għall-proteini tal-ġurdien.
English: Nonafact is used to replace the missing factor IX; it corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Maltese: Nonafact jintuża sabiex jissostitwixxi l-fattur IX nieqes; jikkoreġi d-defiċjenza tal-fattur IX u jagħti kontroll temporanju tad-disturb tal-fsada.
English: Most patients had severe haemophilia B. The studies assessed the number of major or life-threatening bleeding episodes that occurred during treatment, or during and after surgery.
Maltese: L-istudji vvalutaw in-numru ta' episodji ta' fsada maġġuri jew ta' theddida għall-ħajja li seħħew waqt il-kura, jew waqt u wara l-intervent kirurġiku.
English: Nonafact was rated as “good” or “excellent” in its ability to prevent bleeding in patients with haemophilia B.
Maltese: Jekk iseħħ dan, Nonafact jista' ma jaħdimx b'mod effikaċi.
English: How has Nonafact been studied?
Maltese: Kif ġie studjat Nonafact?
English: For the full list of all the side effects reported with Nonafact, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Nonafact, ara l-fuljett ta' tagħrif.
English: IMMUNOSUPPRESSANTS Ciclosporine
Maltese: IMMUNOSOPPRESSANTI Ciclosporine
English: EU/1/13/894/002
Maltese: EU/1/13/894/001 EU/1/13/894/002
English: SVR12 rate % (n/N)
Maltese: Sottogrupp Rata ta' % ta' SVR12 (n/N)
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Maltese: Carbamazepine Phenobarbital Phenytoin
English: ANTICOAGULANTS
Maltese: ANTIKOAGULANTI
English: Tenofovir disoproxil fumaratef (300 mg once daily)d
Maltese: Tenofovir disoproxil fumaratef (300 mg darba kuljum)d
English: Overall
Maltese: Totala
English: ANTIMYCOBACTERIALS Rifampicinf
Maltese: ANTIMIKOBATTERJALI Rifampicinf
English: 12 weeks (n = 256)a
Maltese: (n = 256)a
English: The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.
Maltese: (LLOQ - lower limit of quantification) ta' 25
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf
Maltese: INIBITURI TA' INTEGRASE Raltegravirf
English: • Rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
Maltese: • Rifampicin u rifabutin (antibijotiċi li jintużaw għall-kura ta' infezzjonijiet, li jinkludu t tuberkulożi);
English: Treatment-experienced (LONESTAR-2b)
Maltese: (LONESTAR-2b)
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Maltese: * Tinkludi pazjenti infettati wkoll bil-virus tal-immonodefiċjenza umana (HIV).
English: SVR12 rates were similarly high in subjects with baseline IL28B C/C allele [94/95 (99%)] and non-C/C (C/T or T/T) allele [202/232 (87%)].
Maltese: Ir-rati ta' SVR12 kienu għoljin b'mod simili f'individwi b'IL28B C/C allele [94/95 (99%)] fil-linja bażi u non-C/C (C/T jew T/T) allele [202/232 (87%)].
English: Preliminary SVR12 data are available for 210 subjects.
Maltese: Dejta preliminari dwar SVR12 hi disponibbli għal 210 individwi.
English: Genotype 4, 5 or 6 97% (34/35) Cirrhosis
Maltese: Ġenotip 4, 5 jew 6 97% (34/35)
English: Vitamin K antagonists
Maltese: Antagonisti talvitamina K
English: Overallc Genotype 1a c
Maltese: Ġenotip 1a Ġenotip 1b
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
Maltese: EU/1/13/894/001 28 pillola miksija b'rita EU/1/13/894/002 84 (3 fliexken ta' 28) pillola miksija b'rita
English: • Have kidney problems.
Maltese: • Għandek problemi tal-kliewi.
English: Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Maltese: GS-331007 mhumiex substrati jew inibituri ta' UGT1A1 jew enzimi ta' CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, u CYP2D6.
English: 12 weeks (n = 103)a
Maltese: (n = 103)a
English: 12 weeks (n = 207)
Maltese: (n = 207)
English: 12 weeks (n = 327)
Maltese: (n = 327)
English: INFORMATION IN BRAILLE Sovaldi [Outer packaging only]
Maltese: INFORMAZZJONI BIL-BRAILLE Sovaldi [Ippakkjar ta' barra biss]
English: In HCV replicon assays, the effective concentration (EC50) values of sofosbuvir against full-length replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05, 0.05 and 0.04 μM, respectively, and EC50 values of sofosbuvir against chimeric 1b replicons encoding NS5B from genotype 2b, 5a or 6a were 0.014 to 0.015 μM.
Maltese: F'assaġġi HCV replicon, il-valuri tal-konċentrazzjoni effettiva (EC50) ta' sofosbuvir kontra replicons b'tul sħiħ minn ġenotip 1a, 1b, 2a, 3a u 4a kienu 0.04, 0.11, 0.05, 0.05 u 0.04 μM, rispettivament, u l valuri EC50 ta' sofosbuvir kontra replicons 1b kimeriċi encoding NS5B minn ġenotip 2b, 5a jew 6a kienu 0.014 sa 0.015 μM.
English: The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Maltese: Il-medjan tad-doża ta' ribavirin kien ta' 600 mg-800 mg kuljum f'ġimgħat 4-24.
English: (600 mg single dose)
Maltese: (600 mg doża waħda)
English: In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 subjects) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
Maltese: Fi studju 0126, tnaqqis fl-emoglobina waqt il-kura kien komuni ħafna, bi 32.5% (13/40 individwi) li kellhom tnaqqis fl-emoglobina għal < 10 g/dL, li 1 minnhom kellu wkoll tnaqqis għal <8.5 g/dL.
English: Relative to subjects with normal renal function (eGFR >80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Maltese: (eGFR > 80 mL/min/1.73 m2), l-AUC0-inf ta' sofosbuvir kienet ta' 61%, 107% u 171% ogħla f'individwi b'indeboliment ħafif, moderat u sever tal-kliewi, filwaqt li l-AUC0-inf ta' GS-331007 kienet ta' 55%, 88% u 451% ogħla, rispettivament.
English: Sovaldi + ribavirin + peginterferon alfa 12 weeksa,b
Maltese: Sovaldi + ribavirin + peginterferon alfa 12-il ġimgħaa, b
English: post-transplant (pTVR)b
Maltese: wara t-trapjant (pTVR)b
English: Common disturbance in attention migraine, memory impairment, disturbance in attention
Maltese: Komuni disturbi fl-attenzjoni emigranja, disturbi fil-memorja, disturb fl-attenzjoni
English: 28 out of 40 (70%) subjects achieved SVR12: 22/33 (73%) with HCV genotype 1 infection, 6/6 (100%) with HCV genotype 3 infection, and 0/1 (0%) with HCV genotype 4 infection.
Maltese: 22/33 (73%) b'infezzjoni bl-HCV ta' ġenotip 1, 6/6 (100%) b'infezzjoni bl-HCV ta' ġenotip 3, u 0/1 (0%) b'infezzjoni bl-HCV ta' ġenotip 4.
English: Sofosbuvir was fully active against substitutions associated with resistance to other direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors, NS3 protease inhibitors and NS5A inhibitors.
Maltese: Sofosbuvir kien attiv b'mod sħiħ kontra sostituzzjonijiet assoċjati ma' reżistenza għal antivirali oħrajn li jaġixxu b'mod dirett b'mekkaniżmi ta' azzjoni differenti, bħal inibituri non nucleoside ta' NS5B, inibituri ta' protease NS3 u inibituri ta' NS5A.
English: 12 weeks (n = 68)
Maltese: (n = 68)
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Maltese: Sofosbuvir hu prodroga nucleotide li jgħaddi minn metaboliżmu intraċellulari biex jifforma l-uridine analog triphosphate (GS-461203) farmakoloġikament attiv (GS-461203), li jista' jiġi inkorporat ġo HCV RNA mill-NS5B polymerase u jaġixxi bħala terminatur tal-katina.
English: Post-baseline NS5B sequences were available for 225 of the 226 subjects, with deep sequencing data (assay cutoff of 1%) from 221 of these subjects.
Maltese: Sekwenzi NS5B wara l-linja bażi kienu disponibbli għal 225 mill-226 individwu, b'dejta b'sekwenzar profond (cutoff tal-assaġġ ta' 1%) ta'
English: Sovaldi + ribavirin + peginterferon alfa 12 weeksb
Maltese: Sovaldi + ribavirin + peginterferon alfa 12-il ġimgħab
English: The pharmacokinetics of sofosbuvir and GS-331007 in paediatric subjects have not been established (see section 4.2).
Maltese: Il-farmakokinetika ta' sofosbuvir u GS-331007 f'individwi pedjatriċi ma ġietx stabbilita (ara sezzjoni 4.2).
English: Sovaldi is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Maltese: Sovaldi hu kontraindikat ma' carbamazepine, phenobarbital u phenytoin, indutturi potenti ta' P-gp fl-imsaren (ara sezzjoni 4.3).
English: The pharmacokinetics of sofosbuvir were studied in HCV negative subjects with mild (eGFR ≥50 and <80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and subjects with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
Maltese: Il-farmakokinetika ta' sofosbuvir ġiet studjata f'individwi li kienu negattivi għal HCV, b'indeboliment tal-kliewi ħafif (eGFR ≥ 50 u < 80 mL/min/1.73m2), moderat (eGFR ≥ 30 u < 50 mL/min/1.73m2), u sever (eGFR < 30 mL/min/1.73 m2) u individwi b'ESRD li kienu jeħtieġu l-emodijaliżi wara doża waħda ta' 400 mg ta' sofosbuvir.
English: The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV infected subjects with moderate and severe hepatic impairment (CPT class B and C).
Maltese: Il-farmakokinetika ta' sofosbuvir ġiet studjata wara dożaġġ ta' 7 ijiem ta' 400 mg ta' sofosbuvir f'individwi infettati b'HCV b'indeboliment moderat u sever tal-fwied (CPT klassi B u Ċ).
English: Tenofovir ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91,
Maltese: Tenofovir ↑ Cmax 1.25 (1.08, 1.45)
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir.
Maltese: u 3. Il-preżenza ta' 40% tas-serum uman ma kellu l-ebda effett fuq l-attività kontra HCV ta' sofosbuvir.
English: Genotype 3
Maltese: ġenotip 3
English: The parent sofosbuvir accounts for approximately 4% of drug-related material systemic exposure (see section 5.2).
Maltese: Sofosbuvir ġenitur jammonta għal madwar 4% tal-esponiment sistemiku relatat mal-mediċina (ara sezzjoni 5.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 16 jannar 2014
English: (400 mg twice daily)
Maltese: (400 mg darbtejn kuljum)
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
Maltese: ↑ AUC 4.53 (3.26, 6.30)
English: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Maltese: chronic hepatitis C) fl-adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Maltese: Wara doża waħda orali ta' 400 mg ta' [14C]-sofosbuvir, sofosbuvir u GS-331007 kienu jammontaw għal madwar 4% u > 90% tal-esponiment sistemiku tal-materjal relatat mal-mediċina (it-total tal-AUC
English: Table 3: Interactions between Sovaldi and other medicinal products Medicinal product by therapeutic areas
Maltese: Tabella 3: Interazzjonijiet bejn Sovaldi u prodotti mediċinali oħrajn Prodott mediċinali skont iż-żoni terapewtiċi
English: Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in subjects who are interferon intolerant, ineligible or unwilling.
Maltese: POSITRON kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi placebo, li evalwa 12-il ġimgħa ta' kura b'sofosbuvir u ribavirin (n = 207) meta mqabbla ma' plaċebo (n = 71) f'individwi li kienu intolleranti, ineliġibbli jew li ma ridux interferonin.
English: How to store Sovaldi
Maltese: Tiħux Sovaldi
English: Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Maltese: Prodotti mediċinali li huma indutturi potenti ta' P-gp fl-imsaren (rifampicin, rifabutin, St.
English: The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and
Maltese: Il-medja ta' ± SD EC50 ta' sofosbuvir kontra sekwenzi ta' replicons kimeriċi li jikkodifikaw NS5B minn iżolati kliniċi kienet ta' 0.068 ± 0.024 μM għal ġenotip 1a (n = 67),
English: While subject to active tubular secretion, GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or 3, OCT2, MRP2, P-gp, BCRP or MATE1.
Maltese: Filwaqt li jkun soġġett għal tnixxija tubular attiva, GS-331007 mhuwiex substrat għal trasportaturi tal-kliewi li jinkludu organic anion transporter (OAT) 1 jew 3, OCT2, MRP2, P-gp, BCRP jew MATE1.
English: Genotype 2/3 treatment-experienced SOF+RBV
Maltese: Ġenotip 2/3 qatt ma rċivew kura fil-passat SOF+RBV
English: Genotype 2 (n = 109)
Maltese: (n = 109)
English: Table 5 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Maltese: Tabella 5 tippreżenta r-rati ta' rispons għall-grupp ta' kura b'sofosbuvir + peginterferon alfa + ribavirin.
English: Genotype 1
Maltese: Ġenotip Ġenotip 1
English: Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1).
Maltese: Korsijiet mingħajr interferon għal pazjenti b'infezzjoni bl-HCV ta' ġenotip 1, 4, 5 u 6 b'Sovaldi ma ġewx investigati fi studji ta' fażi 3 (ara sezzjoni 5.1).
English: Table 11: Response rates in study FUSION SOF+RBV
Maltese: Tabella 11: Rati ta' rispons fl-istudju FUSION SOF+RBV
English: Effects on drug levels.
Maltese: Effetti fuq il-livelli tal mediċina.
English: The predominant inactive circulating metabolite GS-331007 that accounts for greater than 90% of drug-related material systemic exposure is formed through pathways sequential and parallel to formation of active metabolite.
Maltese: Il-metabolit predominanti inattiv li jiċċirkola GS-331007 li jammonta għal iktar minn 90% tal-esponiment sistemiku relatat mal-mediċina jiġi ffurmat permezz ta' passaġġi sekwenzjali u paralleli għall-formazzjoni tal-metabolit attiv.
English: In these assays, the in vitro antiviral activity of sofosbuvir against the less common genotypes 4, 5 and 6 was similar to that observed for genotypes 1, 2 and 3.
Maltese: sofosbuvir kontra l-ġenotipi inqas komuni 4, 5 u 6 kienet simili għal dik osservata għal ġenotipi 1, 2
English: Eight subjects (20%) received epoetin and/or a blood product.
Maltese: Tmien individwi (20%) irċivew epoetin u/jew prodott tad-demm.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another DAA (including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta sofosbuvir jintuża flimkien ma' DAA ieħor (inkluż daclatasvir, simeprevir u ledipasvir) u amiodarone konkomitanti u/jew mediċini oħrajn li jbaxxu r-rata ta' taħbit tal-qalb (ara s-sezzjonijiet 4.4 u 4.5).
English: Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Maltese: Tabella 9 tippreżenta r-rati ta' rispons għall-gruppi ta' kura b'sofosbuvir + ribavirin u plaċebo.
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 1.4% for subjects receiving placebo, 0.5% for subjects receiving sofosbuvir + ribavirin for 12 weeks, 0% for subjects receiving sofosbuvir + ribavirin for 16 weeks, 11.1% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2.4% for subjects receiving sofosbuvir + peginterferon alfa + ribavirin for 12 weeks.
Maltese: Il-proporzjon ta' individwi li waqqfu l-kura għal kollox minħabba reazzjonijiet avversi kien ta' 1.4% għal individwi li kienu qed jirċievu plaċebo, 0.5% għal individwi li kienu qed jirċievu sofosbuvir + ribavirin għal 12-il ġimgħa, 0% għal individwi li kienu qed jirċievu sofosbuvir + ribavirin għal 16il ġimgħa, 11.1% għal individwi li kienu qed jirċievu peginterferon alfa + ribavirin għal 24 ġimgħa u 2.4% għal individwi li kienu qed jirċievu sofosbuvir + peginterferon alfa + ribavirin għal 12-il ġimgħa.
English: No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Maltese: norgestimate/ethinyl estradiol mhu meħtieġ meta sofosbuvir u norgestimate/ethinyl estradiol jintużaw fl-istess ħin.
English: When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) <50 mL/min (see also section 5.2).
Maltese: Meta Sovaldi jintuża flimkien ma' ribavirin jew peginterferon alfa/ribavirin, irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin għal pazjenti bi tneħħija tal krejatinina (CrCl) ta' < 50 mL/min (ara wkoll sezzjoni 5.2).
English: Other medicines and Sovaldi
Maltese: Mediċini oħra u Sovaldi
English: Population pharmacokinetic analysis in HCV infected subjects showed that within the age range (19 to 75 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'individwi infettati b'HCV uriet li fil-medda ta' età (19 sa 75 sena) analizzata, l-età ma kellhiex effett klinikament rilevanti fuq l-esponiment għal sofosbuvir u GS-331007.
English: Relative to subjects with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Maltese: ogħla f'individwi b'indeboliment moderat u sever tal-fwied, filwaqt li l-AUC0-24 ta' GS-331007 kien 18% u 9% ogħla, rispettivament.
English: Table 8: SVR12 rates by cirrhosis and genotype in study FISSION
Maltese: Tabella 8: Rati ta' SVR12 skont iċ-ċirrożi u l-ġenotip fl-istudju FISSION Ġenotip 2
English: Cirrhosis n = number of subjects with SVR12 response; N = total number of subjects per group.
Maltese: Ċirrożi ċ n = numru ta' individwi b'rispons għal SVR12; N = numru total ta' individwi f'kull grupp.
English: Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Maltese: Għall-użu biss f'pazjenti ineliġibbli jew intolleranti għal peginterferon alfa (ara sezzjoni 4.4)
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus DAAs.
Maltese: L-użu konkomitanti ta' amiodarone kien limitat permezz tal-iżvilupp kliniku ta' sofosbuvir flimkien ma' DAAs.
English: Elimination Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Maltese: Eliminazzjoni Wara doża orali waħda ta' 400 mg ta' [14C]-sofosbuvir, il-medja tal-irkupru totali tad-doża kienet iktar minn 92%, u kienet tikkonsisti minn madwar 80%, 14%, u 2.5% irkuprata fl-awrina, fl-ippurgar u flarja li tintrema 'l barra man-nifs, rispettivament.
English: Česká republika Gilead Sciences s.r.o.
Maltese: Gilead Sciences s.r.o.
English: The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 4).
Maltese: Ir-reazzjonijiet avversi tal-mediċina li ġejjin ġew identifikati b'sofosbuvir flimkien ma' ribavirin jew flimkien ma' peginterferon alfa u ribavirin (Tabella 4).
English: Clinical studies in subjects with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve subjects - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 1, 4, 5 or 6 HCV infection.
Maltese: Individwi li qatt ma rċivew kura fil-passat - NEUTRINO (studju 110) NEUTRINO kien studju open-label, li kellu parti waħda biss, li evalwa 12-il ġimgħa ta' kura b'sofosbuvir flimkien ma' peginterferon alfa 2a u ribavirin f'pazjenti li qatt ma rċivew kura fil-passat b'infezzjoni bl-HCV ta' ġenotip 1, 4, 5 jew 6.