FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of sofosbuvir and ribavirin in liver transplant adult recipients with chronic hepatitis C was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Maltese: Il-profil tas-sigurtà ta' sofosbuvir u ribavirin f'adulti b'epatite Ċ kronika li jirċievu trapjant tal-fwied, kien simili għal dak osservat f'pazjenti kkurati b'sofosbuvir u ribavirin fi studji kliniċi ta' Fażi 3 (ara sezzjoni 5.1).
English: Dialysis
Maltese: Ċirrożi
English: a. For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin.
Maltese: Għal pazjenti li rċivew kura fil-passat b'infezzjoni HCV ta' ġenotip 1, ma teżisti l-ebda dejta bil-kombinazzjoni ta' sofosbuvir, peginterferon alfa u ribavirin.
English: • shortness of breath, cough
Maltese: • qtugħ ta' nifs, sogħla
English: Genotype Genotype 1
Maltese: Ġenotip 1
English: The dose of ribavirin, when used in combination with Sovaldi is weight-based (<75 kg = 1,000 mg and ≥75 kg = 1,200 mg) and administered orally in two divided doses with food.
Maltese: Id-doża ta' ribavirin, meta tintuża flimkien ma' Sovaldi, hi bbażata fuq il-piż (< 75 kg = 1,000 mg u ≥ 75 kg = 1,200 mg) u tingħata mill-ħalq f'żewġ dożi maqsumin mal-ikel.
English: It is formed through sequential and parallel pathways to the formation of active metabolite.
Maltese: Jiġi ffurmat permezz ta' passaġġi sekwenzjali u paralleli għall-formazzjoni tal-metabolit attiv.
English: The safety profile of sofosbuvir and ribavirin in HCV infected adult patients prior to liver transplantation was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Maltese: Il-profil tas-sigurtà ta' sofosbuvir u ribavirin f'pazjenti adulti infettati b'HCV qabel it-trapjant talfwied kien simili għal dak osservat f'pazjenti kkurati b'sofosbuvir u ribavirin fi studji kliniċi ta' Fażi 3 (ara sezzjoni 5.1).
English: ANALEPTICS Modafinil
Maltese: Modafinil
English: Clinical studies of sofosbuvir included 65 patients aged 65 and over.
Maltese: L-istudji kliniċi ta' sofosbuvir kienu jinkludu 65 pazjent li kellhom 65 sena jew aktar.
English: Treated patients (n = 499) had a median age of 50 years (range: 19 to 77); 66% of the patients were male; 87% were White; 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Maltese: Il-pazjenti kkurati (n = 499) kellhom età medjana ta' 50 sena (medda: 19 sa 77); 66% tal-pazjenti kienu rġiel; 87% kienu Bojod; 3% kienu Suwed; 14% kienu Ispaniċi jew mill-Amerika Latina; ilmedja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 28 kg/m2 (medda: 17 sa 52 kg/m2); 57% kellhom livelli ta' HCV RNA fil-linja bażi ta' iktar minn 6 log10
English: In addition, S282R and L320F substitutions were detected on treatment by deep sequencing in a pre-transplant subject with a partial treatment response.
Maltese: Barra minn hekk, sostituzzjonijiet S282R u L320F ġew osservati matul il-kura permezz ta' sekwenzar profond f'individwu qabel it-trapjant b'rispons parzjali għall-kura.
English: If the starting dose of ribavirin is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing <75 kg and 1,200 mg for patients weighing ≥75 kg).
Maltese: Jekk id-doża tal-bidu ta' ribavirin tkun ittollerata tajjeb, id-doża tista' tiġi titrata għal massimu ta' 1,000-1,200 mg kuljum (1,000 mg għal pazjenti li jiżnu < 75 kg u 1,200 mg għal pazjenti li jiżnu ≥ 75 kg).
English: • getting a cold (nasopharyngitis)
Maltese: • tieħu riħ (nażofarinġite)
English: 20% had cirrhosis; 72% had HCV genotype 3.
Maltese: IU/mL; 21% kellhom ċirrożi; 78% kellhom ġenotip HCV 3; 65% kellhom rikaduta fil-passat.
English: Overallc Genotype 1ac Genotype 1bc No cirrhosisc Cirrhosisc n = number of patients with SVR12 response; N = total number of patients per group.
Maltese: Ġenotip 1aċ Ġenotip 1bċ L-ebda ċirrożiċ Ċirrożiċ n = numru ta' pazjenti b'rispons għal SVR12; N = numru total ta' pazjenti f'kull grupp.
English: The pharmacokinetics of sofosbuvir and GS-331007 have not been established in paediatric patients < 12 years of age.
Maltese: Ilfarmakokinetika ta' sofosbuvir u GS-331007 għadhom ma ġewx determinati f'pazjenti pedjatriċi li jkollhom < 12-il sena.
English: • severe headaches (migraine), memory loss, loss of concentration
Maltese: • uġigħ ta' ras qawwi(emigranja), telf tal-memorja, telf tal-konċentrazzjoni
English: • Oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Maltese: • Oxcarbazepine (mediċina li tintuża għall kura ta' epilessija u għall prevenzjoni ta'
English: a. See Table 4 for weight based ribavirin dosing recommendations b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Maltese: Għandha tingħata konsiderazzjoni li t-tul tat-terapija jista' potenzjalment jiġi estiż għal aktar minn 12-il ġimgħa u sa u mhux aktar minn 24 ġimgħa; speċjalment għal dawk is-sottogruppi li jkollhom fattur wieħed jew aktar storikament assoċjat ma' rati iktar baxxi ta' rispons għal terapiji bbażati fuq interferon (eż. fibrożi/ċirrożi avvanzata, konċentrazzjonijiet virali għoljin fil-linja bażi, razza sewda, ġenotip IL28B mhux CC), l-ebda rispons fil-passat għal terapija b'peginterferon alfa u ribavirin).
English: Effects on drug levels.
Maltese: Effetti fuq il-livelli talmediċina.
English: On-treatment virologic failure < 1% (1/256) Relapseb
Maltese: Riżultat għal pazjenti mingħajr SVR12 Falliment viroloġiku waqt il-kura 1% (1/68) Rikadutaa
English: Treated patients (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the patients were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6.
Maltese: Il-pazjenti kkurati (n = 327) kellhom età medjana ta' 54 sena (medda: 19 sa 70); 64% tal-pazjenti kienu rġiel; 79% kienu Bojod; 17% kienu Suwed; 14% kienu Ispaniċi jew mill-Amerika Latina; ilmedja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 29 kg/m2 (medda: 18 sa 56 kg/m2); 78% kellhom livelli ta' HCV RNA fil-linja bażi ta' iktar minn 6 log10
English: Contents of the pack and other information What Sovaldi contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Sovaldi
English: Treatment-naïve (ELECTRONb and PROTONb) SOF+PEG+RBV 12 weeks
Maltese: Rati ta' rispons fl-istudju NEUTRINO SOF+PEG+RBV
English: The SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed sofosbuvir with velpatasvir treatment and relapsed.
Maltese: Ir-rata ta' SVR kienet ta' 95% (56/59); mit-tliet pazjenti li ma kisbux SVR12, pazjent wieħed lesta t-trattament b'sofosbuvir flimkien ma' velpatasvir u rkada.
English: All patients who achieved SVR12 achieved SVR24 and SVR48.
Maltese: Il-pazjenti kollha li kisbu SVR12, kisbu SVR24 u SVR48.
English: Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected patients in the Phase 3 clinical studies.
Maltese: Żewġ sostituzzjonijiet ta' NS5B, L159F u V321A, ġew osservati f'kampjuni minn rikaduta wara l-kura minn pazjenti multipli infettati b'HCV ta' ġenotip 3 fi studji kliniċi ta' Fażi 3. Ma ġie osservat l-ebda ċaqliq fis-suxxettibilità fenotipika għal sofosbuvir jew ribavirin ta' iżolati ta' individwi b'dawn is-sostituzzjonijiet.
English: Efficacy, in terms of rapid virologic response, has been shown to correlate with exposure to sofosbuvir as well as GS 331007.
Maltese: Intwera li l-effikaċja, f'termini ta' rispons viroloġiku rapidu, tikkorrela ma' esponiment għal sofosbuvir kif ukoll għal GS-331007.
English: HCV replicons expressing the sofosbuvir-associated resistance substitution S282T were fully susceptible to other classes of anti-HCV agents.
Maltese: Replicons HCV li jesprimu s-sostituzzjoni S282T assoċjata ma' reżistenza għal sofosbuvir kienu suxxettibbli b'mod sħiħ għal klassijiet oħrajn ta' mediċini kontra l-HCV.
English: Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 5 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM)
Maltese: Informazzjoni dwar interazzjonijiet ta' Sovaldi ma' prodotti mediċinali potenzjali li jingħataw fl-istess ħin qed jintwerew fil-qosor f'Tabella 5 hawn taħt (fejn 90% intervall ta' kunfidenza (CI - confidence interval) tal-proporzjon tal-geometric least-squares mean (GLSM) kien fil-medda ta' “↔”, estiża 'l fuq “↑”, jew estiża 'l isfel “↓” tal-limiti determinati minn qabel tal-ekwivalenza).
English: The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Maltese: Il-proprjetajiet farmakokinetiċi ta' sofosbuvir u tal-metabolit predominanti li jiċċirkola GS-331007 ġew evalwati f'individwi adulti b'saħħithom u f'pazjenti bl-epatite Ċ kronika.
English: Table 16 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Maltese: Tabella 16 tippreżenta l-analiżi tas-sottogrupp skont il-ġenotip għaċ-ċirrożi u esponiment għall-kura kontra HCV fil-passat.
English: Other medicines and Sovaldi
Maltese: Tiqafx tieħu Sovaldi
English: SOF+RBV 12 weeks (n = 256)a
Maltese: 12-il ġimgħa (n = 256)a
English: Treatment-naïvea (NEUTRINO)
Maltese: Qatt ma rċivew kura fil-passat (NEUTRINO)
English: Sovaldi has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection.
Maltese: Sovaldi ma ġiex studjat fi studju ta' Fażi 3 f'pazjenti li rċivew kura fil-passat, b'infezzjoni bl-HCV ta' ġenotip 1, 4, 5 jew 6.
English: Patients with genotype 2 CHC Sovaldi + ribavirin
Maltese: Kif għandek tieħu Sovaldi
English: Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08) ↔ AUC 0.95 (0.82, 1.09) Cmin (NA)
Maltese: 87 (0.71, 1.08) ↔ AUC 0.95 (0.82, 1.09) Cmin (NA)
English: ESRD Requiring Dialysis
Maltese: L-ebda ċirrożia Ċirrożia
English: Treated patients (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the patients were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
Maltese: Il-pazjenti kkurati (n = 419) kellhom età medjana ta' 51 sena (medda: 19 sa 74); 60% tal-pazjenti kienu rġiel; il-medjan tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 25 kg/m2 (medda: 17 sa 44 kg/m2); il-livell medju tal-HCV RNA fil-linja bażi kien ta' 6.4 log10
English: Genotype 2/3 treatment-experienced SOF+RBV
Maltese: Tabella 13: Rati ta' rispons fl-istudju FUSION SOF+RBV
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13) Cmin (NA)
Maltese: ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13) Cmin (NA)
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30) Cmin (NA)
Maltese: ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30) Cmin (NA)
English: Gilead Sciences Slovakia s.r.o Tel: + 421 232 121 210
Maltese: Gilead Sciences Poland Sp. z o.o. Tel: +48 22 262 8702
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69) ↔ AUC 1.04 (0.90, 1.20) Cmin (NA)
Maltese: ↓ Cmax 0.60 (0.53, 0.69) ↔ AUC 1.04 (0.90, 1.20) Cmin (NA)
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite ranged from 8 to 28 times higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: Fi studji fil-firien, l-esponiment għal sofosbuvir ma setax jiġi determinat iżda l-marġni tal-esponiment ibbażati fuq il-metabolit maġġuri uman kienu bejn 8 u 28 darba ogħla mill-esponiment kliniku b'doża ta' 400 mg ta' sofosbuvir.
English: GS-331007 ↔ Cmax 1.23 (1.14, 1.34) ↔ AUC 0.95 (0.88, 1.03) Cmin (NA)
Maltese: ↔ Cmax 1.23 (1.14, 1.34) ↔ AUC 0.95 (0.88, 1.03) Cmin (NA)
English: The study was designed as a direct comparison of sofosbuvir and ribavirin versus placebo for 12 weeks.
Maltese: L-istudju kien maħsub bħala paragun dirett ta' sofosbuvir u ribavirin kontra plaċebo għal 12-il ġimgħa.
English: Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Maltese: Tabella 23: Riżultati skont il-kors terapewtiku u t-tul tal-kura, paragun bejn l-istudji f'infezzjoni bl-HCV ta' ġenotip 4, 5 u 6
English: Unwilling
Maltese: Suwed
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.20) ↔ AUC 1.03 (0.97, 1.08) Cmin (NA)
Maltese: ↔ Cmax 1.09 (0.99, 1.20) ↔ AUC 1.03 (0.97, 1.08) Cmin (NA)
English: • back pain, muscle spasms
Maltese: • uġigħ fid-dahar, spażmi fil-muskoli
English: Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li l-għeja u disturb fl-attenzjoni, sturdament u vista mċajpra ġew irrapportati waqt il-kura b'sofosbuvir flimkien ma' peginterferon alfa u ribavirin (ara sezzjoni 4.8).
English: Concerning co-administration with other direct-acting antivirals against HCV, see section 4.4.
Maltese: Fir-rigward ta'għoti flimkien ma' antivirali oħrajn li jaġixxu b'mod dirett kontra HCV, ara sezzjoni 4.4.
English: 130 mg/daily])
Maltese: 1000 mg/jum
English: The dose linearity of sofosbuvir and its primary metabolite, GS-331007, was evaluated in fasted healthy subjects.
Maltese: Il-linearità tad-doża ta' sofosbuvir u tal-metabolit primarju tiegħu, GS-331007, ġew evalwati f'individwi f'saħħithom sajmin.
English: GS-331007 ↔ Cmax 1.06 (0.99, 1.14) ↔ AUC 1.01 (0.97, 1.04) Cmin (NA)
Maltese: ↔ Cmax 1.06 (0.99, 1.14) ↔ AUC 1.01 (0.97, 1.04) Cmin (NA)
English: Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Maltese: Tel: + + 353 (0) 1 686 1888
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Maltese: Għandha tingħata konsiderazzjoni għall-kura ta' dawn il-pazjenti, u li t-tul tatterapija b'sofosbuvir, peginterferon alfa u ribavirin jista' potenzjalment jiġi estiż għal aktar minn 12-il ġimgħa u mhux aktar minn 24 ġimgħa; speċjalment għal dawk is-sottogruppi li jkollhom fattur wieħed jew aktar storikament assoċjat ma' rati iktar baxxi ta' rispons għal terapiji bbażati fuq interferon (l-ebda rispons fil-passat għal terapija b'peginterferon alfa u ribavirin, fibrożi/ċirrożi avvanzata, konċentrazzjonijiet virali għoljin fil-linja bażi, razza sewda, ġenotip IL28B mhux CC).
English: SOF+PEG+RBV 12 weeks
Maltese: SOF+PEG+RBV 12-il ġimgħa Totalċ
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin (see section 4.4).
Maltese: Effetti teratoġeniċi u/jew embrijoċidali sinifikanti ntwerew fl-ispeċi kollha ta' annimali esposti għal ribavirin (ara sezzjoni 4.4).
English: The active metabolite is formed in hepatocytes and not observed in plasma.
Maltese: Il-metabolit attiv jiġi ffurmat f'epatoċiti u mhuwiex osservat fil-plażma.
English: • fever, chills, flu-like symptoms
Maltese: • deni, tertir ta' bard, sintomi bħal tal-influwenza
English: Regimen/Duration
Maltese: Reżistenza inkroċjata
English: Co-administration of Sovaldi with medicinal products that inhibit P-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
Maltese: L-għoti flimkien ta' Sovaldi ma' prodotti mediċinali li jinibixxu P-gp u/jew BCRP jistgħu jżidu l-konċentrazzjoni ta' sofosbuvir fil-plażma mingħajr ma jżidu l-konċentrazzjoni ta' GS-331007 fil-plażma, u għalhekk Sovaldi jista' jingħata flimkien ma' P-gp u/jew ma' inibituri ta' BCRP.
English: Patients had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic HCV infection pre-transplantation.
Maltese: IU/mL fl-iscreening u evidenza dokumentata ta' infezzjoni kronika bl-HCV qabel it-trapjant.
English: Women of childbearing potential / contraception in males and females
Maltese: Waqfien tad-doża fl-adulti u adolexxenti
English: The extent of absorption of sofosbuvir was increased approximately 1.8-fold, with little effect on peak concentration.
Maltese: Il-grad ta' assorbiment ta' sofosbuvir żdied b'madwar 1.8 drabi, bi ftit effett fuq l-ogħla konċentrazzjoni.
English: Biotransformation
Maltese: Tenofovir
English: Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Maltese: Interazzjonijiet bejn Sovaldi u prodotti mediċinali oħrajn Prodott mediċinali skont iż-żoni terapewtiċi
English: SOF+RBV 24 weeks
Maltese: SOF+RBV 24 ġimgħa
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at the adverse dose was 29 times (rat) and 123 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: GS-331007 fid-doża avversa kien 29 darba (fil-firien) u 123 darba (fil-klieb) ogħla millesponiment kliniku f'doża ta' 400 mg ta' sofosbuvir.
English: Hepatic impairment
Maltese: IMMUNOSOPPRESSANTI
English: The highest documented dose of sofosbuvir was a single supratherapeutic dose of sofosbuvir 1,200 mg administered to 59 healthy subjects.
Maltese: L-ogħla doża dokumentata ta' sofosbuvir kienet doża waħda supraterapewtika ta' sofosbuvir 1,200 mg mogħtija lil 59 individwu b'saħħithom.
English: Cirrhosis No
Maltese: Mhux Suwed
English: No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly.
Maltese: L-ebda aġġustament fid-doża ta' sofosbuvir jew tenofovir disoproxil mhu meħtieġ meta sofosbuvir u tenofovir disoproxil jintużaw fl-istess ħin.
English: Thus, the optimal treatment duration in this population has not been established (see also sections 4.2 and 5.1).
Maltese: Għalhekk, l-aħjar tul ta' kura f'din il-popolazzjoni ma ġiex stabbilit (ara wkoll sezzjonijiet 4.2. u 5.1).
English: FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in patients who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders).
Maltese: FUSION kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, li evalwa 12 jew 16-il ġimgħa ta' kura b'sofosbuvir u ribavirin f'pazjenti li ma kisbux SVR, u li rċivew kura fil-passat ibbażata fuq interferon (dawk li rkadew u dawk li ma rrispondewx).
English: Interaction not studied Close monitoring of INR is recommended with all vitamin K antagonists.
Maltese: Antagonisti tal-vitamina K L-interazzjoni ma ġietx studjata.
English: ESRD Requirin g
Maltese: FULJETT TA' TAGĦRIF
English: ↓ AUC 0.76 (0.63, 0.91)
Maltese: ↓ Cmax 0.64 (0.53, 0.77) ↓ AUC 0.76 (0.63, 0.91) Cmin (NA)
English: A single subject with genotype 5 and all 6 patients with genotype 6 HCV infection in this study achieved SVR12.
Maltese: Individwu wieħed b'ġenotip 5 u s-6 pazjenti kollha b'infezzjoni bl-HCV ta' ġenotip 6 f'dan l-istudju kisbu SVR12.
English: The adverse reactions are listed below by body system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt, skont is-sistema tal-klassifika tal-organi tal-ġisem u l-frekwenza.
English: Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sovaldi.
Maltese: Ikkonsulta s-Sommarju tal-Karatteristiċi tal-Prodott għal prodotti mediċinali li jiġu preskritti fl-istess ħin qabel tibda t-terapija b'Sovaldi.
English: Table 15 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Maltese: Tabella 15 tippreżenta r-rati ta' rispons għall-gruppi ta' kura ta' sofosbuvir + ribavirin għal 12-il ġimgħa u 24 ġimgħa.
English: Treatment-naïve (FISSION)
Maltese: Qatt ma rċivew kura fil-passat (FISSION)
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Maltese: Għandha tingħata konsiderazzjoni għall-kura ta' dawn il-pazjenti, u li t-tul tat-terapija b'sofosbuvir, peginterferon alfa u ribavirin jista' potenzjalment jiġi estiż għal aktar minn 12-il ġimgħa u sa u mhux aktar minn 24 ġimgħa; speċjalment għal dawk is-sottogruppi li jkollhom fattur wieħed jew aktar storikament assoċjat ma' rati iktar baxxi ta' rispons għal terapiji bbażati fuq interferon (fibrożi/ċirrożi avvanzata, konċentrazzjonijiet virali għoljin fil-linja bażi, razza sewda, ġenotip IL28B mhux CC).
English: Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Maltese: Tabella 13 tippreżenta r-rati ta' rispons għall-gruppi ta' kura ta' sofosbuvir + ribavirin għal 12-il ġimgħa u 16-il ġimgħa.
English: b. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Maltese: b. Oħrajn jinkludu pazjenti li ma kisbux SVR12 u ma ssodisfawx il-kriterji ta' falliment viroloġiku (eż., ma ġewx segwiti (lost to follow-up)).
English: Sovaldi [Outer packaging only]
Maltese: INFORMAZZJONI BIL-BRAILLE Sovaldi [Ippakkjar ta' barra biss]
English: SOF+RBV 12 weeks
Maltese: SOF+RBV
English: The recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy are provided in Table 1.
Maltese: Il-prodott(i) mediċinali mogħti(ja) flimkien rakkomandat(i) u t-tul ta' żmien tat-terapija kkombinata b'Sovaldi huma pprovduti f'Tabella 1.
English: Digoxin and lisinopril
Maltese: Digoxin u lisinopril
English: System organ class /adverse reaction terms
Maltese: Sistema tal-klassifika tal-organi /termini ta' reazzjonijiet avversi
English: Ethinyl estradiol and levonorgestrel
Maltese: Ethinyl estradiol u levonorgestrel
English: Needles (2)
Maltese: Labar (2)
English: • flatulence (passing gas)
Maltese: • flatulenza (gass)
English: Needle (monoject)
Maltese: Labra (monoject)
English: IMPORTANT:
Maltese: Importanti:
English: E. Attach the needle to the pen,
Maltese: Bydureon jiġi injettat fil-ġilda (taħt il-ġilda).
English: Powder poly (D,L-lactide-co-glycolide) sucrose
Maltese: Trab poly (D,L-lactide-co-glycolide) sucrose
English: Number at Risk
Maltese: Numru f'Riskju
English: Acute pancreatitis (see section 4.4)
Maltese: Pankreatite akuta (ara sezzjoni 4.4)
English: Interaction with warfarin
Maltese: Interazzjoni ma' warfarin
English: Placebo + Insulin glargine
Maltese: Plaċebo + Insulina glargine
English: Pruritus, and/ or urticaria
Maltese: Ħakk, u/ jew urtikarja
English: HR=hazard ratio, CI=confidence interval
Maltese: HR=proporzjon ta' periklu, CI=intervall ta' fiduċja
English: #nominal p-value <0.05,
Maltese: # valur p nominali <0.05,