FrancophonIA/ELRC3.0 huggingface dataset:
English: Pravastating
Lithuanian: Talkas
English: GS-331007 ↑ Cmax 1.33 (1.22, 1.44)
Lithuanian: GS-331007 ↑ Cmax 1,33 (1,22; 1,44) ↑ AUC 1,44 (1,41; 1,48) ↑ Cmin 1,53 (1,47; 1,59)
English: Harvoni is contraindicated with rifampicin (see section 4.3).
Lithuanian: Harvoni negalima vartoti su rifampicinu (žr.
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.19)
Lithuanian: GS-331007 ↔ Cmax 1,09 (0,99; 1,19) ↔ AUC 1,02 (0,97; 1,08)
English: In female rats, the mean number of corpora lutea and implantation sites were slightly reduced at maternal exposures 6-fold the exposure in humans at the recommended clinical dose.
Lithuanian: Žiurkių patelėms, ekspozicijai 6 kartus viršijant ekspoziciją žmogui, nustatytą skiriant rekomenduojamą klinikinę dozę, nustatytas šiek tiek sumažėjęs geltonkūnių ir implantacijos vietų kiekis.
English: No dose adjustment of Harvoni or tacrolimus is required at initiation of co-administration.
Lithuanian: Pradedant skirti kartu, Harvoni ar takrolimuzo dozės koreguoti nereikia.
English: NS5A transient replicons Median (range)a
Lithuanian: Stabilūs replikonai NS5A laikini replikonai
English: Harvoni is contraindicated with rifabutin (see section 4.3).
Lithuanian: Harvoni negalima vartoti su rifabutinu (žr.
English: ↑ Statins
Lithuanian: Ranitidinase
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Lithuanian: Darunaviras, sustiprintas ritonaviru (800 mg/ 100 mg kartą per parą) + emtricitabinas/ tenofoviro dizoproksilio fumaratas (200 mg/ 300 mg kartą per parą)/ ledipasviras (90 mg kartą per parą)c/ sofosbuviras (400 mg kartą per parą)c, d
English: Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50)
Lithuanian: Sofosbuviras ↑ Cmax 1,15 (0,88; 1,50) ↔ AUC 1,11 (1,00; 1,24)
English: GS 331007 ↔ Cmax 1.15 (1.03, 1.27)
Lithuanian: GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12) Cmin (DN)
English: Age (years): median (range) Male gender Race: Black/ African American White Genotype 1aa IL28CC genotype FibroTest-Determined Metavir scoreb F0-F1 F2 F3-F4 Not interpretable a Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Lithuanian: Dviems 12 savaičių gydymo LDV/SOF grupės pacientams, vienam 12 savaičių gydymo LDV/SOF+RBV grupės pacientui, dviems 24 savaičių gydymo LDV/SOF grupės pacientams ir dviems 24 savaičių gydymo LDV/SOF+RBV grupės pacientams 1 genotipo potipis nebuvo nustatytas.
English: These medicines can decrease the amount of ledipasvir in your blood.
Lithuanian: Jeigu Jūs vemiate po Harvoni vartojimo, tai gali turėti įtakos Harvoni kiekiui Jūsų kraujyje.
English: The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing.
Lithuanian: 3 fazės tyrimo metu populiacijos arba giliosios sekoskaitos metodu su atsparumu sofosbuvirui susijusio S282T pakeitimo pradinio NS5B sekoje nebuvo aptikta nė vienam pacientui.
English: ↑ Cmin 1.39 (1.29, 1.51)
Lithuanian: Ledipasviras ↑ Cmax 1,45 (1,34; 1,56) ↑ AUC 1,39 (1,28; 1,49) ↑ Cmin 1,39 (1,29; 1,51)
English: Male
Lithuanian: Vyrai
English: Table 4: Ribavirin dose modification guideline for co-administration with Harvoni in adults Laboratory values
Lithuanian: Ribavirino dozės koregavimo rekomendacijos suaugusiesiems, kai jis vartojamas kartu su Harvoni
English: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Lithuanian: Nustatyta, kad, ypač vartojant kartu su preparatais nuo ŽIV, kurių sudėtyje yra tenofoviro dizoproksilio fumarato, ir su farmakokinetiką stiprinančiu preparatu (ritonaviru arba kobicistatu), Harvoni didina tenofoviro ekspoziciją.
English: H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Lithuanian: Famotidinas (40 mg vienkartinė dozė)/ ledipasviras (90 mg vienkartinė dozė)c/ sofosbuviras (400 mg vienkartinė dozė)c,d
English: IMMUNOSUPPRESSANTS Ciclosporing
Lithuanian: IMUNOSUPPRESANTAI Ciklosporinasg
English: Patients were randomised in a 1:1:1 ratio to one of the three treatment groups and stratified by HCV genotype (1a versus 1b).
Lithuanian: Pacientai buvo suskirstyti pagal HCV genotipą (1a plg.
English: Genotype 4a
Lithuanian: 1b genotipas a.
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43)
Lithuanian: Sofosbuviras ↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57)
English: Ledipasvir
Lithuanian: Ledipasviras
English: No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
Lithuanian: Ledipasviro, sofosbuviro ar GS-331007 kliniškai svarbių farmakokinetikos skirtumų, susijusių su rase, nebuvo nustatyta.
English: ↑ Cmin 1.63 (1.45, 1.84) Ritonavir ↔ Cmax 0.86 (0.79, 0.93)
Lithuanian: ↑ Cmax 1,40 (1,1; 1,66) ↔ AUC 1,20 (1,04; 1,39) ↔ Cmin 0,98 (0,79; 1,22)
English: ↑ Cmin 1.91 (1.76, 2.08) Sofosbuvir ↑ Cmax 1.33 (1.14, 1.56)
Lithuanian: Sofosbuviras ↑ Cmax 1,33 (1,14; 1,56) ↑ AUC 1,36 (1,21; 1,52)
English: GS 331007 ↔ Cmax 1.04 (0.97, 1.11)
Lithuanian: GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04) Cmin (DN)
English: GS-331007 ↓ Cmax 0.73 (0.65, 0.83)
Lithuanian: GS-331007 ↓ Cmax 0,73 (0,65; 0,83) ↔ AUC 1,04 (0,89; 1,22)
English: Ledipasvir/sofosbuvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Lithuanian: Atvirojo tyrimo (tyrimo 0154) metu ledipasvirą / sofosbuvirą 12 savaičių vartojo 18 pacientų, kuriems nustatytas 1 genotipo LHC ir sunkus inkstų veiklos sutrikimas.
English: Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
Lithuanian: Ledipasviras ↓ Cmax 0,65 (0,56; 0,76) ↓ AUC 0,41 (0,36; 0.48)
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69)
Lithuanian: GS-331007 ↓ Cmax 0,60 (0,53; 0,69) ↔ AUC 1,04 (0,90; 1,20)
English: Harvoni is contraindicated with carbamazepine (see section 4.3).
Lithuanian: Harvoni negalima vartoti su karbamazepinu (žr.
English: GS-331007 ↔ Cmax 1.13 (1.07, 1.20)
Lithuanian: GS-331007 ↔ Cmax 1,13 (1,07; 1,20) ↔ AUC 1,06 (1,01; 1,12)
English: Not interpretable 0% (0)
Lithuanian: 0 % (0 iš 22) 0 % (0 iš 22)
English: Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5).
Lithuanian: Tokių vaistinių preparatų nerekomenduojama vartoti kartu su Harvoni (žr.
English: Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
Lithuanian: Ledipasviras ↓ Cmax 0,80 (0,69; 0,93) ↔ AUC 0,89 (0,76; 1,06)
English: Ledipasvir ↓ Cmax 0.83 (0.69, 1.00)
Lithuanian: Ledipasviras ↓ Cmax 0,83 (0,69; 1,00) ↔ AUC 0,98 (0,80; 1,20)
English: ↑ Cmin 1.47 (1.38, 1.57) Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Lithuanian: Ledipasviras ↑ Cmax 1,63 (1,51; 1,75) ↑ AUC 1,78 (1,64; 1,94) ↑ Cmin 1,91 (1,76; 2,08)
English: ↔ Cmin 1.04 (0.98, 1.11) Tenofovir ↑ Cmax 1.79 (1.56, 2.04)
Lithuanian: Tenofoviras ↑ Cmax 1,79 (1,56; 2,04) ↑ AUC 1,98 (1,77; 2,23) ↑ Cmin 2,63 (2,32; 2,97)
English: GS-331007 ↔ Cmax 1.06 (0.97, 1.14)
Lithuanian: GS-331007 ↔ Cmax 1,06 (0,97; 1,14) ↔ AUC 1,06 (1,02; 1;11)
English: ↑ Cmin 1.59 (1.49, 1.70) Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Lithuanian: Ledipasviras ↔ Cmax 1,11 (0,99; 1,24) ↔ AUC 1,12 (1,00; 1,25) ↔ Cmin 1,17 (1,04; 1,31)
English: LDV/SOF+RBV 24 weeks (n = 307)a,b
Lithuanian: 24 savaitės (n = 307)a,b
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min).
Lithuanian: Išgėrus vienkartinę 90 mg ledipasviro dozę, ledipasviro farmakokinetika buvo tiriama HCV neigiamiems pacientams, kuriems nustatytas sunkus (aGFG < 30 ml/min.
English: Post-transplant
Lithuanian: Iki transplantacijos CPT B
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Lithuanian: Sofosbuviras ↓ Cmax 0,63 (0,52; 0,75) ↓ AUC 0,73 (0,65; 0,82)
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05)
Lithuanian: GS-331007 ↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30)
English: ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, 1.13)
Lithuanian: ↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
English: • you have diabetes.
Lithuanian: • jeigu laukiate kepenų transplantanto;
English: ↔ Cmin 1.12 (1.03, 1.21) Tenofovir ↔ Cmax 1.32 (1.25, 1.39)
Lithuanian: Tenofoviras ↔ Cmax 1,32 (1,25; 1,39) ↑ AUC 1,40 (1,31; 1,50) ↑ Cmin 1,91 (1,74; 2,10)
English: ↔ Cmin 1.07 (0.89, 1.28) Norgestrel ↔ Cmax 1.18 (0.99, 1.41)
Lithuanian: Norgestrelis ↔ Cmax 1,03 (0,87; 1,23) ↔ AUC 0,99 (0,82; 1,20) ↔ Cmin 1,00 (0,81; 1,23)
English: Package leaflet: Information for the user Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir This medicine is subject to additional monitoring.
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS Harvoni 90 mg/400 mg plėvele dengtos tabletės ledipasviras/sofosbuviras
English: Oxcarbazepine
Lithuanian: Okskarbazepinas
English: Yesd
Lithuanian: h.
English: Ledipasvir ↑ Cmax 1.98 (1.78, 2.20)
Lithuanian: Ledipasviras ↑ Cmax 1,98 (1,78; 2,20) ↑ AUC 2,13 (1,89; 2,40) ↑ Cmin 2,36 (2,08; 2,67)
English: ↔ Cmin 1.16 (1.08, 1.25) Sofosbuvir ↔ Cmax 1.05 (0.93, 1.20)
Lithuanian: Sofosbuviras ↔ Cmax 1,08 (0,85; 1,35) ↔ AUC 1,21 (1,09; 1,35)
English: Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Lithuanian: Sofosbuviras ↓ Cmax 0,64 (0,53; 0,77) ↓ AUC 0,76 (0,63; 0,91) Cmin (DN)
English: ↑ Cmin 1.91 (1.74, 2.10) Ledipasvir ↔ Cmax 1.01 (0.95, 1.07)
Lithuanian: Ledipasviras ↔ Cmax 1,01 (0,95; 1,07) ↔ AUC 1,08 (1,02; 1,15) ↔ Cmin 1,16 (1,08; 1,25)
English: Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42)
Lithuanian: Sofosbuviras ↔ Cmax 1,12 (0,88; 1,42) ↔ AUC 1,00 (0,80; 1,25)
English: ↑ Cmin 2.63 (2.32, 2.97) Ledipasvir ↓ Cmax 0.66 (0.59, 0.75)
Lithuanian: Ledipasviras ↓ Cmax 0,66 (0,59; 0,75) ↓ AUC 0,66 (0,59; 0,75) ↓ Cmin 0,66 (0,57; 0,76)
English: EXP
Lithuanian: Taipd
English: Otherb
Lithuanian: SVA
English: Table 12: Response rates in study ION-1 LDV/SOF
Lithuanian: Atsako dažnis ION-1 tyrimo metu
English: ↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Lithuanian: ↔ Cmax 1,25 (1,18; 1,32) ↑ AUC 1,59 (1,49; 1,70) ↑ Cmin 4,25 (3,47; 5,22)
English: ↔ Cmin 0.91 (0.83, 0.99) Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Lithuanian: ↔ Cmax 1,02 (0,96; 1,08) ↔ AUC 1,04 (1,00; 1,08) ↔ Cmin 1,03 (0,97; 1,10)
English: ↔ Cmin 0.95 (0.81, 1.12) Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08)
Lithuanian: Sofosbuviras ↔ Cmax 0,96 (0,88; 1,05) ↔ AUC 1,08 (1,02; 1,15)
English: ↑ Cmin 2.18 (1.91, 2.50) Sofosbuvir ↔ Cmax 1.01 (0.88, 1.15)
Lithuanian: Sofosbuviras ↔ Cmax 1,01 (0,88; 1,15) ↔ AUC 1,11 (1,02; 1,21)
English: ↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
Lithuanian: ↔ Cmax 1,02 (0,98; 1,06) ↔ AUC 1,05 (1,02; 1,08) ↔ Cmin 1,06 (0,97; 1,15)
English: When ribavirin is added to Harvoni, refer also to the Summary of Product Characteristics of ribavirin.
Lithuanian: Kai kartu su Harvoni vartojama ribavirino, taip pat žr.
English: ↔ Cmin 1.26 (1.17, 1.36) Sofosbuvir ↔ Cmax 1.08 (0.85, 1.35)
Lithuanian: Sofosbuviras ↔ Cmax 1,00 (0,76; 1,32) ↔ AUC 0,95 (0,82; 1,10)
English: ↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir
Lithuanian: ↔ Dolutegraviras ↔ Ledipasviras ↔ Sofosbuviras ↔ GS-331007
English: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18)
Lithuanian: Ciklosporinas ↔ Cmax 1,06 (0,94; 1,18) ↔ AUC 0,98 (0,85; 1,14)
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Lithuanian: Sofosbuviras ↔ Cmax 1,05 (0,93; 1,20) ↔ AUC 1,10 (1,01; 1,21)
English: GS-331007 ↔ Cmax 1.23 (1.14, 1.34)
Lithuanian: GS-331007 ↔ Cmax 1,23 (1,14; 1,34) ↔ AUC 0,95 (0,88; 1,03)
English: ↔ Cmin 0.97 (0.86, 1.10) Ledipasvir ↑ Cmax 1.45 (1.34, 1.56)
Lithuanian: Sofosbuviras ↑ Cmax 1,45 (1,10; 1,92) ↑ AUC 1,34 (1,12; 1,59)
English: Previously treated adults with cirrhosis - SIRIUS - Genotype 1
Lithuanian: Anksčiau gydyti suaugusieji, sergantys arba nesergantys kepenų ciroze - ION-2 (0109 tyrimas)1 genotipas
English: ↔ Cmin 0.95 (0.74, 1.22) Sofosbuvir ↓ Cmax 0.95 (0.68, 1.33)
Lithuanian: Sofosbuviras ↔ Cmax 0,87 (0,71; 1,08) ↔ AUC 0,95 (0,82; 1,09)
English: Raltegravir ↓ Cmax 0.82 (0.66, 1.02)
Lithuanian: Raltegraviras ↓ Cmax 0,82 (0,66; 1,02) ↔ AUC 0,85 (0,70; 1,02) ↑ Cmin 1,15 (0,90; 1,46)
English: ↔ Cmin 1.04 (0.96, 1.12) Tenofovir ↑ Cmax 1.47 (1.37, 1.58)
Lithuanian: Tenofoviras ↑ Cmax 1,47 (1,37; 1,58) ↔ AUC 1,35 (1,29; 1,42) ↑ Cmin 1,47 (1,38; 1,57)
English: Hepatic impairment
Lithuanian: Inkstų veiklos sutrikimas
English: These measures will help to protect the environment .
Lithuanian: Šios priemonės padės apsaugoti aplinką.
English: • if you are pregnant, think you are pregnant or planning to have a baby.
Lithuanian: • jeigu esate nėščia, manote, kad galbūt esate nėščia arba planuojate pastoti.
English: NO-0485 Oslo Norway
Lithuanian: NO-0485 Oslo Norvegija
English: These effects usually do not last longer than 30 minutes.
Lithuanian: Dažniausiai šis poveikis netrunka ilgiau nei 30 minučių.
English: The doctor, nurse or medical technician will let you know when you can stand up.
Lithuanian: Gydytojas, slaugytojas arba medicinos technikas Jums praneš, kada galėsite atsistoti.
English: They don't usually need any treatment.
Lithuanian: Dažniausiai jokio gydymo nereikia.
English: Classification agreement Cohen's kappa
Lithuanian: Klasifikacijos susitarimas Cohen'o kappa
English: Patients initiated exercise using a standard or modified Bruce protocol.
Lithuanian: Pacientai pradėjo mankštą, naudodami standartinį arba modifikuotą Bruce protokolą.
English: The potential risk for humans is unknown.
Lithuanian: Galima rizika žmogui nėra žinoma.
English: 400 micrograms
Lithuanian: 400 mikrogramų
English: Adverse reactions occurred in approximately 80% of patients.
Lithuanian: Nepageidaujamos reakcijos pasireiškė maždaug 80 % pacientų.
English: The dose injected does not depend on your weight.
Lithuanian: Leidžiama dozė nepriklauso nuo Jūsų svorio.
English: UNIQUE IDENTIFIER - 2D BARCODE
Lithuanian: UNIKALUS IDENTIFIKATORIUS - 2D BARKODAS
English: More serious side effects include:
Lithuanian: Sunkesnis šalutinis poveikis yra:
English: Stolker et al. 2015 (n=149) van Nunen et al. 2015 (n=98)
Lithuanian: Stolker ir kiti, 2015 (n=149) van Nunen ir kiti, 2015 (n=98)
English: Harmful effects have been seen in animal studies but it is not known if there is a risk to humans.
Lithuanian: Su gyvūnais atlikti tyrimai parodė kenksmingą poveikį, bet nėra žinoma, ar yra pavojus žmogui.
English: For the measurement of FFR, five independent studies have been conducted.
Lithuanian: FSR išmatuoti buvo atlikti penki nepriklausomi tyrimai.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Lithuanian: Atidžiai perskaitykite visą šį lapelį, prieš pradedami vartoti vaistą, nes jame pateikiama Jums svarbi informacija.
English: They normally start soon after the Rapiscan injection and are usually over within 30 minutes.
Lithuanian: Įprastai jis prasideda netrukus po Rapiscan injekcijos ir dažniausiai išnyksta per 30 minučių.
English: The side effects are usually mild.
Lithuanian: Dažniausiai šalutinis poveikis būna lengvas.
English: What Rapiscan is and what it is used for
Lithuanian: Kas yra Rapiscan ir kam jis vartojamas
English: ADVANCE ADVANCE Combined MPI 1
Lithuanian: ADVANCE ADVANCE Apibendrinti MPI 1
English: Long QT syndrome
Lithuanian: Ilgo QT sindromas
English: This is because caffeine can interfere with the effect of Rapiscan.
Lithuanian: Tai yra dėl to, kad kofeinas gali trikdyti Rapiscan poveikį.
English: Bronchoconstriction
Lithuanian: Bronchokonstrikcija
English: It is not known whether Rapiscan can pass into breast milk and will only be given to you if your doctor thinks it is necessary.
Lithuanian: Nėra žinoma, ar Rapiscan išsiskiria į motinos pieną ir bus skiriamas tik jeigu Jūsų gydytojas mano, kad tai būtina.
English: Your doctor will only give you Rapiscan if it is clearly necessary.
Lithuanian: Gydytojas skirs Jums Rapiscan tik jei tai tikrai būtina;
English: • ringing in the ears
Lithuanian: • skambėjimas ausyse;
English: Children and adolescents Rapiscan should not be used in children and adolescents below the age of 18 years.
Lithuanian: Vaikams ir paaugliams Rapiscan negalima vartoti vaikams ir paaugliams iki 18 metų.
English: The median time between scans was 7 days (range of 1-104 days).
Lithuanian: Vidutinis laiko tarpas tarp tyrimų atlikimo buvo 7 dienos (ribos: 1- 104 dienų).
English: • anxiety, difficulty sleeping
Lithuanian: • nerimas, sunkumas užmigti;
English: The half-life of this initial phase is approximately 2 to 4 minutes.
Lithuanian: Preparato pradinės fazės pusperiodis yra maždaug nuo 2 iki 4 minučių.
English: Rapiscan with food and drink
Lithuanian: Rapiscan vartojimas su maistu ir gėrimais
English: Sensitivity Specificity
Lithuanian: Jautrumas Specifiškumas
English: Adenosine was treated as a gold standard to estimate sensitivity, specificity, and the proportion of accuracy.
Lithuanian: Adenozinas buvo laikomas „auksiniu standartu“, su kuriuo galima įvertinti jautrumą, specifiškumą ir tikslumą.
English: Multiple injections
Lithuanian: Kelios injekcijos
English: Dyspnoea did not correlate with a decrease in FEV1.
Lithuanian: Dusulys nekoreliavo su FEV1 sumažėjimu.
English: Rate Difference (regadenoson - Adenosine) (± 95% Confidence Interval
Lithuanian: Santykio skirtumas (Regadenozonas-adenozinas) (± SP) 95 % patikimumo intervalas
English: Safety and tolerability of repeated use of this product within 24 hours has not been characterised.
Lithuanian: Šio preparato kartotinio vartojimo saugumas ir toleravimas per 24 valandų laikotarpį nebuvo nustatytas.
English: Consideration should be given to delaying regadenoson administration until blood pressure is well controlled
Lithuanian: Reikėtų apsvarstyti galimybę atidėti regadenozonas vartojimą tol, kol kraujospūdis bus gerai kontroliuojamas.
English: It may cause other symptoms (headache or shortness of breath) that could affect your ability to drive or use machinery.
Lithuanian: Tai gali sukelti kitus simptomus (galvos skausmą arba dusulį), kurie gali paveikti Jūsų gebėjimą vairuoti ir valdyti mechanizmus.
English: The healthcare professionals will be responsible for the storage and disposal of this medicinal product.
Lithuanian: Už šio vaisto saugojimą ir išmetimą bus atsakingi sveikatos priežiūros specialistai.
English: The headache was considered severe in 3% of subjects.
Lithuanian: Stiprus galvos skausmas nustatytas 3 % asmenų.
English: Hyperaemia may fluctuate between sub-maximum and maximum until it slowly vanishes.
Lithuanian: Hiperemija gali svyruoti tarp submaksimalios ir didžiausios, kol ji lėtai išnyks.
English: The doctor can then see if the heart muscles are getting enough blood flow when it is under stress.
Lithuanian: Tuomet gydytojas gali matyti, ar į širdies raumenį patenka pakankamai kraujo, kai ji patiria stresą.
English: All adverse reactions are presented in the table below and are listed by system organ class and frequency.
Lithuanian: Visos toliau lentelėje pateiktos nepageidaujamos reakcijos išvardytos pagal organų sistemos klasę ir dažnį.
English: • if you have any heart or blood vessel condition, particularly one that gets worse when your blood pressure decreases.
Lithuanian: • jeigu Jums yra kokia nors širdies arba kraujagyslių būklė, ypač, kuri pablogėja, kai sumažėja kraujospūdis.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Lithuanian: Dažnis yra apibūdinamas taip: labai dažni (≥ 1/10), dažni (nuo ≥ 1/100 iki < 1/10), nedažni (nuo ≥ 1/1 000 iki < 1/100) ir reti (≥ 1/10 000 iki < 1/1 000).
English: • changes in heart tracing tests (electrocardiogram)
Lithuanian: • širdies veiklos sekimo tyrimo (elektrokardiogramos) pokyčiai;
English: Like all medicines, Rapiscan can cause side effects, although not everybody gets them.
Lithuanian: Šis vaistas, kaip ir kiti, gali sukelti šalutinį poveikį, nors jis pasireiškia ne visiems žmonėms.
English: Rapiscan is injected by a healthcare professional (a doctor, nurse or medical technician) in a medical facility where your heart and blood pressure can be monitored.
Lithuanian: Rapiscan leidžia sveikatos priežiūros specialistas (gydytojas, slaugytojas arba medicinos technikas) medicinos įstaigoje, kurioje galima stebėti Jūsų širdies veiklą ir kraujo spaudimą.
English: • if you have a heart rhythm disorder called long QT syndrome.
Lithuanian: • jeigu Jūs sergate širdies ritmo sutrikimu, vadinamu ilgo QT sindromu;
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Lithuanian: • Periodiškai atnaujinami saugumo protokolai Šio vaistinio preparato periodiškai atnaujinamo saugumo protokolo pateikimo reikalavimai išdėstyti Direktyvos 2001/83/EB 107c straipsnio 7 dalyje numatytame Sąjungos referencinių datų sąraše (EURD sąraše), kuris skelbiamas Europos vaistų tinklalapyje
English: These images show how well blood flows to the muscles of the heart.
Lithuanian: Šie vaizdai rodo, kaip gerai kraujas teka į širdies raumenį.
English: If any of these apply to you, tell your doctor before you are given the injection.
Lithuanian: Jeigu bet kuri iš šių būklių Jums tinka, prieš Jums suleidžiant injekciją pasakykite apie tai savo gydytojui.
English: However, the maximum observed plasma concentrations as well as volumes of distribution estimates were similar across the groups.
Lithuanian: Tačiau didžiausių stebėtų koncentracijų plazmoje bei pasiskirstymo tūrių vertinimai grupėse buvo panašūs.
English: Contents of the pack and further information
Lithuanian: Pakuotės turinys ir kita informacija
English: MPI 2
Lithuanian: MPI 2 tyrimai
English: • if you have asthma or lung disease.
Lithuanian: • jeigu Jūs sergate astma arba plaučių liga.
English: For use in radionuclide MPI: This product is to be administered only once within a 24 hour period.
Lithuanian: Naudojimui radionuklidiniam MPV: šį preparatą galima vartoti tik kartą per 24 valandų laikotarpį.
English: If you have any further questions, ask your doctor or pharmacist.
Lithuanian: • Jeigu kiltų daugiau klausimų, kreipkitės į gydytoją arba vaistininką.
English: An intermediate phase follows, with a half-life on average of 30 minutes coinciding with loss of the pharmacodynamic effect.
Lithuanian: Po jos seka vidurinioji fazė, kurios pusperiodis vidutiniškai yra 30 minučių, jis sutampa su farmakodinaminio poveikio mažėjimu.
English: A total of 1,871 of these patients had images considered valid for the primary efficacy evaluation, including 1,294 (69%) men and 577 (31%) women with a median age of 66 years (range 26-93 years of age).
Lithuanian: Iš viso 1 871 šių pacientų tyrimo vaizdai nustatyti tinkami pirminio veiksmingumo vertinimui, iš jų 1 294 (69 %) vyrų ir 577 (31 %) moterų, kurių vidutinis amžius buvo 66 metai (amžiaus ribos: 26-93 metai).
English: Patients who did not achieve ≥ 85% maximum predicted heart rate (MPHR) and/or ≥ 5 METS (metabolic equivalents), transitioned into a 3-5 minutes walking recovery where during the first 3 minutes of recovery, patients were randomized 1:1.
Lithuanian: Pacientai, kurie nepasiekė ≥ 85 % maksimalaus numatyto širdies susitraukimų dažnio (MNŠSD) ir/arba ≥ 5 MET (metabolinių ekvivalentų), perėjo į 3-5 minučių žingsniavimo atsigavimą, kur per pirmąsias 3 atsigavimo minutes pacientai buvo atsitiktiniu būdu suskirstyti santykiu 1:1.
English: The risk of significant increases in blood pressure may be higher in patients with uncontrolled hypertension.
Lithuanian: Stipraus kraujospūdžio padidėjimo rizika gali būti didesnė pacientams, kuriems pasireiškia nekontroliuojama hipertenzija.