FrancophonIA/ELRC3.0 huggingface dataset:
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Lithuanian: A grupė: dasabuviras ir ombitasviras / paritapreviras / ritonaviras + RBV (12
English: Treatment-naïve and peginterferon+ribavirin-experienced, with compensated cirrhosis
Lithuanian: Anksčiau peginterferonu+ribavirinu gydyti tiriamieji, nesergantys kepenų ciroze
English: Ribavirin dose modification did not impact SVR rates.
Lithuanian: Ribavirino dozės keitimas neturėjo įtakos ilgalaikio virusologinio atsako (IVA) dažniui.
English: ANTIBIOTICS (SYSTEMIC ADMINISTRATION)
Lithuanian: ANTIMIKOBAKTERINIAI (ANTITUBERKULIOZINIAI) VAISTINIAI PREPARATAI
English: Lopinavir/ritonavir 400/100 mg twice daily or 800/200 mg once daily is contraindicated dasabuvir
Lithuanian: 400/100 mg lopinaviro / ritonaviro du kartus per parą arba 800/200 mg vieną kartą per parą negalima vartoti kartu su dasabuviru ir ombitasviru / paritapreviru / ritonaviru, nes padidėja paritapreviro ekspozicijos (žr.
English: dasabuvir and ombitasvir/paritaprevir/ritonavir for 8 weeks Treated subjects (N=166) had a median age of 53 years (range: 22 to 82); 56.6% were female; 3.0% were Asian; 0.6% were Black; 7.2% had baseline HCV RNA levels of at least 6,000,000 IU per mL;
Lithuanian: Dasabuviras ir ombitasviras / paritapreviras / ritonaviras (8 savaites) Gydytų asmenų (N=166) amžiaus mediana buvo 53 metai (intervalas nuo 22 iki 82), 56,6 % buvo moterys, 3,0 % azijiečiai, 0,6 % juodaodžiai, 7,2 % pradinės HCV RNR koncentracijos buvo ne mažesnės kaip 6 000 000 TV/ml, 9 % buvo pažengusi fibrozė (F3) ir 98,2 % buvo nustatyta HCV 1b genotipo infekcija (trims tyrime dalyvavusiems pacientams buvo atitinkamai nustatyta 1a, 1d ir 6 genotipo infekcija).
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Lithuanian: Mechanizmas: paritapreviras, ombitasviras ir dasabuviras gali slopinti UGT1A1.
English: ombitas vir/parit aprevir/r itonavir atazanavir dasabuvir ombitasvir paritaprevir
Lithuanian: Dasabuviras + ombitasviras / paritapreviras / ritonaviras atazanaviro dasabuviro ombitasviro paritapreviro
English: Ελλάδα
Lithuanian: (žr.
English: Three interrupted dasabuvir and ombitasvir/paritaprevir/ritonavir for one to seven days, including one on ethinyloestradiol.
Lithuanian: Trys pacientai, iš kurių viena pacientė vartojo etinilestradiolį, 1-7 dienoms sustabdė dasabuviro ir ombitasviro / paritapreviro / ritonaviro vartojimą.
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in subjects with mild (CrCl: 60 to 89 ml/min), moderate (CrCl: 30 to 59 ml/min) and severe (CrCl: 15 to 29 ml/min) renal impairment, relative to subjects with normal renal function.
Lithuanian: Sutrikusi inkstų funkcija Buvo įvertintos 25 mg ombitasviro, 150 mg paritapreviro ir 100 mg ritonaviro derinio, vartojamo kartu su 400 mg dasabuviro, farmakokinetinės savybės tiriamųjų, kuriems yra lengvas (kreatinino klirensas
English: Pharmacokinetic steady state for dasabuvir when coadministered with ombitasvir/paritaprevir/ritonavir is achieved after approximately 12 days of dosing.
Lithuanian: Dasabuviro skiriamo kartu su ombitasviru / paritapreviru / ritonaviru farmakokinetikos pusiausvyra pasiekiama per maždaug 12 dozavimo parų.
English: Refer to the ombitasvir/paritaprevir/ritonavir Summary of Product Characteristics for details.
Lithuanian: Ombitasviro / paritapreviro / ritonaviro farmakologinės savybės aprašytos šio preparato charakteristikų santraukoje.
English: If the combination is used, repeated ECGmonitoring should be done, see section 4.4.
Lithuanian: intervalą. Jeigu vartojamas toks derinys, reikia pakartotinai registruoti EKG
English: No dose adjustment is necessary for norethindrone or dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Lithuanian: Noretindrono arba dasabuviro + ombitasviro / paritapreviro / ritonaviro dozės keisti nereikia.
English: 8 weeks may be considered in previously untreated genotype 1binfected patients with minimal to moderate fibrosis** (see section 5.1, GARNET study)
Lithuanian: 1b genotipu infekuotiems pacientams, kuriems yra minimali ar vidutinio sunkumo fibrozė**, gali būti apsvarstytas
English: 400 mg twice daily
Lithuanian: Raltegraviras 400 mg du kartus per parą
English: Dasabuvir is administered with ombitasvir/paritaprevir/ritonavir.
Lithuanian: Dasabuviras vartojamas kartu su ombitasviru / paritapreviru / ritonaviru.
English: See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Lithuanian: Dozavimo rekomendacijas pacientams, užsikrėtusiems HCV + ŽIV-1 infekcijomis, žr.
English: 6.6 Special precautions for disposal
Lithuanian: SPECIALIOS ATSARGUMO PRIEMONĖS DĖL NESUVARTOTO VAISTINIO
English: nordiazepam
Lithuanian: nordiazepam o ↓
English: Common: may affect up to 1 in 10 people
Lithuanian: Dažnas: gali pasireikšti ne dažniau kaip 1 iš 10 žmonių
English: In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatmentemergent variants were seen in all 3 drug targets in 30 subjects.
Lithuanian: mutacijos buvo stebėtos 50 tiriamųjų, NS5A mutacijos - 46 tiriamiesiems, NS5B mutacijos
English: HCV Genotype 1a dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV
Lithuanian: 1a genotipo HCV Dasabuviras ir ombitasviras / paritapreviras / ritonaviras kartu su RBV
English: Darunavir combined with ombitasvir/paritaprevir/ ritonavir + dasabuvir is not recommended in patients with extensive PI resistance.
Lithuanian: Klinikinės pastabos vartoti kartu su ombitasviru / paritapreviru / ritonaviru + dasabuviru pacientams, kuriems pasireiškia didelis atsparumas proteazės inhibitoriams.
English: Monitor ciclosporin levels and adjust dose and/or dosing frequency as needed.
Lithuanian: Reikia stebėti ciklosporino koncentracijas ir keisti dozę ir
English: Elderly
Lithuanian: Kiti
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when dasabuvir is taken in combination with ribavirin (see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information).
Lithuanian: 4.6 Vaisingumas, nėštumo ir žindymo laikotarpis Vaisingos moterys / vyrų ir moterų kontracepcija Pacientės ir pacientų partnerės turi imtis visų atsargumo priemonių, kad nepastotų, vartodamos dasabuvirą kartu su ribavirinu.
English: ↑ Sulfamethoxazole,
Lithuanian: Tiriamieji,
English: *Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
Lithuanian: infekcija, reikia taikyti dozavimo rekomendacijas, skirtas 1a genotipo infekcija užsikrėtusiems pacientams.
English: The persistence of dasabuvir, ombitasvir and paritaprevir resistance-associated amino acid substitutions in NS5B, NS5A and NS3, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials.
Lithuanian: Su atsparumu dasabuvirui, ombitasvirui ir paritaprevirui susijusio atitinkamai NS5B, NS5A ir NS3
English: Rosuvastatin
Lithuanian: Pravastatinas
English: Clinical trial in subjects with compensated cirrhosis
Lithuanian: Sergantys kompensuota kepenų ciroze
English: Oral use
Lithuanian: Vaisto paskirtis
English: Mechanism: CYP3A4 induction by phenytoin.
Lithuanian: Mechanizmas: fenitoinas sužadina CYP3A4.
English: The replicon activity of dasabuvir was attenuated 12- to 13fold in the presence of 40% human plasma.
Lithuanian: Dasabuviro replikono aktyvumas sumažėjo nuo 12
English: Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Lithuanian: Mechanizmas: paritapreviras, ombitasviras ir dasabuviras slopina
English: Darunavir/ ritonavir 800/100 mg once daily (administere d in the evening)
Lithuanian: rekomenduojama darunaviro dozė yra 800 mg vieną kartą per parą, be ritonaviro
English: Smephenytoin Mechanism: CYP2C19 induction by ritonavir.
Lithuanian: Mechanizmas: ritonaviras sužadina CYP2C19.
English: This regimen can be used in the absence of extensive PI resistance (i.e. lack of darunavir associated RAMs), see also section 4.4.
Lithuanian: nėra atsparumo darunavirui mutacijų), taip pat žr. 4.4 skyrių.
English: No dose adjustment of dasabuvir is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 4.2).
Lithuanian: Dasabuviro dozės pacientams, kuriems yra lengvas, vidutinio sunkumo ar sunkus inkstų funkcijos sutrikimas, ar dializuojamiems pacientams, kuriems yra galutinė inkstų ligos stadija,
English: dasabu vir + ombitas vir/parit aprevir/ ritonavi r atazanavir
Lithuanian: Dasabuviras + ombitasviras / paritapreviras / ritonaviras atazanaviro
English: ANTICONVULSANTS carbamazepine dasabu vir +
Lithuanian: ND Sofosbuviro dozės vartojant su dasabuviru +
English: SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
Lithuanian: IVA12 anksčiau negydytiems tiriamiesiems, užsikrėtusiems 1b genotipo infekcija, kuriems nėra cirozės
English: NNRTIs other than rilpivirine (efavirenz, etravirine, and nevirapine) are contraindicated (see section
Lithuanian: etravirino ir nevirapino) vartoti negalima (žr.
English: tenofovir dasabuvir ombitasvir paritaprevir
Lithuanian: tenofoviro dasabuviro ombitasviro paritapreviro
English: The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Lithuanian: Toks derinys yra susijęs su hiperbilirubinemijos (įskaitant akių geltą) rizikos padidėjimu,
English: ↑ sofosbuvir
Lithuanian: ombitasviro
English: Mechanism: CYP3A4 inhibition by ritonavir.
Lithuanian: Mechanizmas: fenobarbitalis sužadina CYP3A4.
English: NA No dose adjustment is necessary for escitalopram.
Lithuanian: ND Escitalopramo dozės keisti nereikia.
English: Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Lithuanian: Gydymo dasabuviru sukeltos NS5B M414T, G554S, S556G,
English: Lansoprazole Mechanism: CYP2C19 induction by ritonavir.
Lithuanian: Mechanizmas: ritonaviras indukuoja CYP2C19
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Lithuanian: Dasabuviras ir ombitasviras / paritapreviras / ritonaviras kartu su RBV 12 savaičių n/N
English: No dose adjustment is necessary for methadone and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Lithuanian: Metadono ir dasabuviro + ombitasviro / paritapreviro / ritonaviro dozės keisti nereikia.
English: Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Lithuanian: tiriamųjų buvo vyriškos lyties, 11,8 % - juodaodžiai, 20,7 % anksčiau buvo patyrę depresiją arba bipolinį sutrikimą, 86,6 % pradinės HCV RNR koncentracijos buvo ne mažesnės kaip 800 000 TV/ml, 18,4 % buvo diagnozuota vartų (portinė) kepenų fibrozė (F2) ir 17,7 % - tiltinė kepenų fibrozė (F3).
English: No dose adjustment is necessary for buprenorphine/naloxon e and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Lithuanian: Buprenorfino / naloksono ir dasabuviro + ombitasviro / paritapreviro / ritonaviro dozės keisti nereikia.
English: No dose adjustment is necessary for raltegravir or dasabuvir ombitasvir/paritaprevir/ ritonavir.
Lithuanian: Raltegraviro arba dasabuviro + ombitasviro / paritapreviro / ritonaviro dozės keisti nereikia.
English: Adverse reactions identified with dasabuvir in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Lithuanian: paritapreviru / ritonaviru arba dasabuvirą kartu su ombitasviru / paritapreviru / ritonaviru ir ribavirinu
English: Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim ombitasvir
Lithuanian: Mechanizmas: dasabuviro ekspozicijos padidėjimas, nes gemfibrozilis slopina
English: Baseline platelet count, median (× 109/L) < 90, n (%) ≥ 90, n (%) Pooled analyses of clinical trials Durability of response Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Lithuanian: Ir IVA12, ir IVA24 HCV RNR duomenis turėjo iš viso 660 tiriamųjų, dalyvavusių II ir III fazės klinikiniuose tyrimuose.
English: dasabu vir + ombitas vir/parit aprevir/ ritonavi r ciclosporin
Lithuanian: Dasabuviras + ombitasviras / paritapreviras / ritonaviras ciclosporino
English: Vomiting
Lithuanian: Smefenitoinas
English: Atazanavir
Lithuanian: Lansoprazolas
English: SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
Lithuanian: IVA12 anksčiau negydytiems tiriamiesiems, užsikrėtusiems 1a genotipo HCVinfekcija,
English: Treatment-emergent amino acid substitutions in the pooled analysis of dasabuvir and ombitasvir/paritaprevir/ritonavir, with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510)
Lithuanian: Bendra gydymo sukelto aminorūgšties pasikeitimo, gydant pagal planą, kurio sudėtyje yra dasabuviro ir ombitasviro / paritapreviro / ritonaviro kartu su ribavirinu (RBV) ar be jo,
English: Angioedema
Lithuanian: Takrolimuzas
English: SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Lithuanian: 1b genotipo HCVinfekcija, remiantis PEARL II tyrimo duomenimis
English: Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects).
Lithuanian: Kiti a. 97,5 % pasikliautinieji intervalai buvo naudojami, vertinant svarbiausias veiksmingumo vertinamąsias baigtis (bendrojo IVA12 dažnį); 95 % pasikliautinieji intervalai buvo naudojami, vertinant papildomas veiksmingumo vertinamąsias baigtis (IVA12 dažnius tiriamiesiems, užsikrėtusiems 1a ir 1b genotipų HCV infekcija).
English: How long to take Exviera for
Lithuanian: Kiek laiko vartoti Exviera tabletes?
English: 25 mg once daily administered in the morning, with food
Lithuanian: 25 mg vieną kartą per parą,
English: This is because serious or lifethreatening effects can occur when Exviera and ombitasvir/paritaprevir/ritonavir are taken with these medicines.
Lithuanian: • jeigu vartojate kurį nors iš toliau lentelėje išvardytų vaistų, nes vartojant Exviera ir ombitasvirą / paritaprevirą / ritonavirą kartu su šiais vaistais, gali pasireikšti sunkus ar gyvybei pavojingas poveikis.
English: dasabuvir and ombitasvir/paritaprevir /ritonavir
Lithuanian: Dasabuviras + ombitasviras / paritapreviras / ritonaviras buprenorfino
English: ↑ fluvastatin ↑ pitavastatin ↔ dasabuvir ↔ ombitasvir ↔ paritaprevir
Lithuanian: Numatomas: fluvastatino ↑ pitavastatino ↑ dasabuviro ↔ ombitasviro ↔ paritapreviro ↔
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir dasabuvi r + ombitas vir/parit aprevir/r itonavir dolutegravir
Lithuanian: kad paritapreviras, dasabuviras ir ombitasviras slopina UGT1A1 ir ritonaviras slopina CYP3A4
English: 9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection).
Lithuanian: 1a genotipo HCV infekcija, 31, 3 % - 1b genotipo HCV infekcija.
English: Frequency dasabuvir and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Lithuanian: ritonaviras + ribavirinas * N = 2 044
English: ANTIHYPERLIPIDAEMICS Gemfibrozil
Lithuanian: PRIEŠTRAUKULINIAI VAISTINIAI PREPARATAI Karbamazepinas
English: dasabu vir + Ombita svir/par itaprevi r /ritonav ir
Lithuanian: Dasabuviras + ombitasviras / paritapreviras / ritonaviras emtricitabin o
English: dasabu vir + ombitas vir/parit aprevir/ ritonavi r everolimus
Lithuanian: Dasabuviras + ombitasviras / paritapreviras / ritonaviras everolimuzo
English: The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Lithuanian: Vartojant kartu su su dasabuviru + ombitasviru / paritapreviru / ritonaviru, rekomenduojama atazanaviro dozė yra 300 mg, be ritonaviro.
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
Lithuanian: Kitokių nei rilpivirinas nenukleozidinių atvirkštinės transkriptazės inhibitorių (NNATI) (efavirenzo,
English: Breastfeeding
Lithuanian: Gemfibrozilis
English: As the incidence of such elevations was 26% among women taking a concomitant ethinyloestradiol-containing medicine, such medicinal products are contraindicated with dasabuvir and ombitasvir/paritaprevir/ritonavir.
Lithuanian: Kadangi tokio padidėjimo dažnis tarp moterų, vartojusių etinilestradiolio vaistinius preparatus, buvo 26 %,
English: Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection
Lithuanian: Omeprazolas, lansoprazolas, ezomeprazolas Skrandžio opoms ir kitiems skrandžio sutrikimams gydyti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Lithuanian: REGISTRAVIMO / PERREGISTRAVIMODATA
English: Ethinyloestradiol containing oral contraceptives are contraindicated (see section 4.3).
Lithuanian: Etinilestradiolio turinčių geriamųjų kontraceptikų vartoti kartu negalima (žr.
English: dasabuvir and ombitasvir/paritaprevir /ritonavir + ribavirin
Lithuanian: Dasabuviras ir ombitasviras / paritapreviras / ritonaviras + ribavirinas
English: • There is a risk for birth defects when ribavirin is given to a female patient that becomes pregnant.
Lithuanian: • Jeigu ribavirino vartojanti moteris pastoja, yra vaisiaus apsigimimų rizika.
English: SVR12, n/N (%) [95% CI] Outcome for subjects not achieving SVR12 On-treatment virologic failure Post-treatment relapse Otherb a. Includes all HCV GT1 subjects in Part 2 excluding Arm G subjects that did not receive recommended regimen.
Lithuanian: Apima visus 2 dalies HCV GT1 tiriamuosius, išskyrus G grupės tiriamuosius, kurie negavo rekomenduojamo gydymo režimo.
English: ↑ sulfasalazine
Lithuanian: Sulfasalazinas
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV 12 weeks
Lithuanian: Dasabuviras ir ombitasviras / paritapreviras / ritonaviras su RBV
English: ↑ naloxone
Lithuanian: ritonavirą.
English: TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Lithuanian: Klinikiniai tyrimai, kuriuose dalyvavo tiriamieji, sergantys kompensuota ciroze TURQUOISE-II -anksčiau negydyti arba pegIFN + RBV gydyti tiriamieji, sergantys kompensuota kepenų ciroze
English: trimethopri m
Lithuanian: Deferasiroksa s
English: A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with dasabuvir + ombitasvir/paritaprevir /ritonavir.
Lithuanian: ND Vartojant kartu su dasabuviru + ombitasviru / paritapreviru / ritonaviru reikia apsvarstyti hidrokodono dozės sumažinimą
English: increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
Lithuanian: Atkrytis 2 iš 15 pacientų (patvirtintas HCV RNR ≥ 15 TV/ml kiekis po gydymo prieš arba per IVA12
English: Relapse
Lithuanian: Nemiga
English: Dasabuvir and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Lithuanian: Pacientams, kuriems buvo persodintos kepenys, rekomenduojama skirti dasabuvirą ir ombitasviro / paritapreviro / ritonaviro derinį kartu su ribavirinu 24 savaites.
English: No dose adjustment needed for dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Lithuanian: Dasabuviro + ombitasviro / paritapreviro / ritonaviro dozės keisti nereikia.
English: This is due to liver function changes during treatment with dasabuvir + ombitasvir/paritaprevir/ ritonavir
Lithuanian: To reikia dėl kepenų funkcijos pokyčio gydymo dasabuviru ir ombitasviru / paritapreviru / ritonaviru metu.
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir
Lithuanian: Mechanizmas: ketokonazolas ir paritapreviras / ritonaviras /ombitasviras slopina
English: ombitasvir/paritaprevir/ritonavir with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Lithuanian: 12 arba 24 savaičių gydymas ombitasviru / paritapreviru / ritonaviru su dasabuviru arba be jo, kartu su pagal svorį parenkamu ribavirinu arba be jo.
English: Mechanism: CYP3A4 induction by carbamazepi ne.
Lithuanian: Klinikinės pastabos karbamazepinas sužadina CYP3A4.
English: Duloxetine 60 mg single dose dasabu vir + ombitas vir/parit aprevir/ ritonavi r duloxetine
Lithuanian: Dasabuviras + ombitasviras / paritapreviras / ritonaviras duloksetino
English: dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 or 24 weeks with or without ribavirin (investigator chosen dose) for GT1 and GT4 infection
Lithuanian: 12 arba 24 savaičių GT1 ir GT4 infekcijų gydymas dasabuviru ir ombitasviru / paritapreviru / ritonaviru su ribavirinu arba be jo (tyrėjo parinkta doze).
English: Axumin fluciclovine (
Lithuanian: Axumin fluciklovinas (
English: The full EPAR for Axumin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lithuanian: Išsamų Axumin EPAR rasite agentūros interneto svetainėje adresu: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Axumin?
Lithuanian: Kokios priemonės taikomos siekiant užtikrinti saugų ir veiksmingą Axumin vartojimą?
English: Other information about Axumin
Lithuanian: Kita informacija apie Axumin
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Axumin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Lithuanian: Todėl agentūros Žmonėms skirtų vaistinių preparatų komitetas (CHMP) priėjo prie išvados, kad Axumin nauda yra didesnė už jo keliamą riziką, ir rekomendavo leisti vartoti šį vaistą ES.
English: It is not intended to provide practical advice on how to use Axumin.
Lithuanian: Šiame dokumente nepateikta praktinės informacijos apie tai, kaip vartoti Axumin.
English: What is Axumin and what is it used for?
Lithuanian: Kas yra Axumin ir kam jis vartojamas?
English: The most common side effects with Axumin (seen in between 1 and 10 patients in 100) are taste disturbances, altered sense of smell, and pain or rash at the site of injection.
Lithuanian: Dažniausi Axumin šalutiniai reiškiniai (pasireiškę 1-10 pacientų iš 100) yra skonio pojūčių sutrikimai, padidėjęs jautrumas kvapams ir skausmas arba bėrimas injekcijos vietoje.
English: Axumin is available as a solution for injection, which is given as a single injection into a vein around 3 to 5 minutes before the patient is to undergo a PET scan.
Lithuanian: Axumin tiekiamas injekcinio tirpalo forma, kuris pacientui leidžiamas į veną maždaug 3-5 minutes prieš atliekant PET skenavimą.
English: Why is Axumin approved?
Lithuanian: Kodėl Axumin buvo patvirtintas?
English: Axumin is a ‘radiopharmaceutical': it contains the active substance fluciclovine (18F), which emits a small amount of radiation.
Lithuanian: Axumin yra radioaktyvusis preparatas: jo sudėtyje yra veikliosios medžiagos fluciklovino (18F), kuris skleidžia nedidelį kiekį radiacijos.
English: Axumin delivers a very low amount of radiation which could pose a very low risk of cancer and hereditary abnormalities.
Lithuanian: Axumin skleidžia labai nedidelį radiacijos kiekį, dėl kurio gali kilti labai menka vėžio ir apsigimimo rizika.
English: What benefits of Axumin have been shown in studies?
Lithuanian: Kokia Axumin nauda nustatyta tyrimuose?