FrancophonIA/ELRC3.0 huggingface dataset:
English: The exposure to GS-331007 was not altered in the presence of a high-fat meal.
Slovenian: Prisotnost obroka z visoko vsebnostjo maščobe ni spremenila izpostavljenosti presnovku GS-331007.
English: Treatment-experienced co-infected with HIV (PHOTON-1)
Slovenian: Predhodno zdravljeni s sočasno okužbo s HIV
English: Rilpivirine ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04)
Slovenian: ↔ Cmax 1,05 (0,97; 1,15) ↔ AUC 1,06 (1,02; 1,09)
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA)
Slovenian: ↓ AUC 0,52 (0,46; 0,59) Cmin (n/n)
English: Genotype 2/3 treatment-naïve SOF+RBV 12 weeks (n = 68)
Slovenian: Genotip 2/3 predhodno zdravljeni SOF+RBV 24 tednov (n = 28)
English: Intolerant
Slovenian: ANALEPTIKI
English: Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08) ↔ AUC 0.95 (0.82, 1.09) Cmin (NA)
Slovenian: ↔ Cmax 0,87 (0,71; 1,08) ↔ AUC 0,95 (0,82; 1,09) Cmin (n/n)
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, 1.40) Cmin (NA)
Slovenian: ↓ Cmax 0,73 (0,59; 0,90) ↔ AUC 1,09 (0,84; 1,40) Cmin (n/n)
English: Discontinuation of dosing in adults and adolescents If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.4).
Slovenian: Dajanje zdravila Sovaldi kot monoterapija se ne priporoča, zato ga je treba predpisati v kombinaciji z drugimi zdravili za zdravljenje okužbe s hepatitisom C. Ob trajni ukinitvi drugih zdravil, ki se uporabljajo v kombinaciji z zdravilom Sovaldi, je treba ukiniti tudi uporabo zdravila Sovaldi (glejte poglavje 4.2).
English: Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
Slovenian: Preglednica 20: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 1
English: SOF+RBV 12 weeks
Slovenian: SOF+RBV 12 tednov
English: SOF+RBV 12 weeks (n = 73)a
Slovenian: SOF+RBV 12 tednov (n = 73)a
English: Emtricitabine ↔ Cmax 0.97 (0.88, 1.07) ↔ AUC 0.99 (0.94, 1.05) ↔ Cmin 1.04 (0.98, 1.11)
Slovenian: ↔ Cmax 0,97 (0,88; 1,07) ↔ AUC 0,99 (0,94; 1,05)
English: Gilead Sciences Ireland UC Tel: + 353 (0) 214 825999
Slovenian: Tel: + 353 (0) 214 825999
English: Overall Genotype 1a Genotype 1b No cirrhosis Cirrhosis
Slovenian: Skupaj Genotip 1a Genotip 1b
English: Treated patients (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the patients were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL; 16% had cirrhosis; 49% had HCV genotype 3.
Slovenian: Mediana starost zdravljenih bolnikov (n = 278) je bila 54 let (razpon: 21 do 75); 54 % bolnikov je bilo moških; 91 % je bilo belcev; 5 % je bilo črne rase; 11 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 18 do 53 kg/m2); 70 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 16 % jih je imelo cirozo; 49 % jih je imelo HCV genotipa 3.
English: The safety and efficacy of Sovaldi in adolescents aged 12 to <18 years are based on data from 50 patients who were treated with Sovaldi and ribavirin for 12 weeks (genotype 2 patients) and 24 weeks (genotype 3 patients) in a Phase 2, open-label clinical trial.
Slovenian: 50 bolnikov, zdravljenih z zdravilom Sovaldi in ribavirinom 12 tednov (bolniki z genotipom 2) oz.
English: Norgestromin ↔ Cmax 1.06 (0.93, 1.22)
Slovenian: ↔ Cmax 1,06 (0,93; 1,22)
English: ↔ AUC 1.19 (0.98, 1.44)
Slovenian: ↔ AUC 1,19 (0,98; 1,44) Cmin (n/n)
English: ANALEPTICS Modafinil
Slovenian: Modafinil
English: Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Slovenian: Preglednica 21: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 2
English: Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 20 to Table 23) present data from Phase 2 and Phase 3 studies relevant to the dosing to help clinicians determine the best regimen for individual patients.
Slovenian: V naslednjih preglednicah (preglednica 20 do preglednice 23) so predstavljeni podatki študij 2. faze in
English: Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Slovenian: Sovaldi z okskarbazepinom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
English: Treated patients (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the patients were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers.
Slovenian: Mediana starost zdravljenih bolnikov (n = 201) je bila 56 let (razpon: 24 do 70); 70 % bolnikov je bilo moških; 87 % je bilo belcev; 3 % so bili črne rase; 9 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 29 kg/m2 (razpon: 19 do 44 kg/m2); 73 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 34 % jih je imelo cirozo; 63 % jih je imelo HCV genotipa 3; 75 % jih je imelo predhodno relaps.
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.
Slovenian: Mediana starost zdravljenih bolnikov (n = 327) je bila 54 let (razpon: 19 do 70); 64 % bolnikov je bilo moških; 79 % je bilo belcev; 17 % je bilo črne rase; 14 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 29 kg/m2 (razpon: 18 do 56 kg/m2); 78 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 17 % jih je imelo cirozo; 89 % jih je imelo HCV genotipa 1 in 11 % jih je imelo HCV genotipa 4, 5 ali 6.
English: SOF+RBV 16 weeks (n = 35)
Slovenian: SOF+RBV 16 tednov (n = 35)
English: Table 22: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Slovenian: Preglednica 22: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 3
English: Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12)
Slovenian: ↓ Cmax 0,57 (0,44; 0,75) ↓ AUC 0,73 (0,59; 0,91)
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).
Slovenian: Razmisliti je treba o zdravljenju teh bolnikov in morebitnem podaljšanju trajanja zdravljenja s sofosbuvirjem, peginterferonom alfa in ribavarinom na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom, napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču,
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;
Slovenian: Mediana starost zdravljenih bolnikov (n = 499) je bila 50 let (razpon: 19 do 77); 66 % bolnikov je bilo moških; 87 % je bilo belcev; 3 % so bili črne rase; 14 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 17 do 52 kg/m2); 57 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 20 % jih je imelo cirozo; 72 % jih je imelo HCV genotipa 3.
English: SOF+RBV 12 weeks (n = 11)
Slovenian: SOF+RBV 12 tednov (n = 11)
English: ↔ AUC 1.08 (0.93, 1.25)
Slovenian: ↔ AUC 1,04c (0,89; 1,22)
English: ↔ AUC 1.05 (0.92, 1.20)
Slovenian: ↔ AUC 1,05 (0,92; 1,20) Cmin (n/n)
English: Response rates for patients with cirrhosis at baseline are presented in Table 10 by HCV genotype.
Slovenian: Stopnje odziva za bolnike s cirozo ob izhodišču so predstavljene v preglednici 10 po genotipu HCV. Preglednica 10: Stopnje SVR12 po cirozi in genotipu v študiji FISSION
English: Overall No cirrhosis
Slovenian: Brez ciroze Ciroza
English: No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in dizoproksiltenofovirata odmerka sofosbuvirja ali dizoproksiltenofovirata ni treba prilagajati.
English: SOF+RBV 16 weeks (n = 63)
Slovenian: SOF+RBV 16 tednov (n = 63)
English: Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders:
Slovenian: Infekcijske in parazitske bolezni:
English: • shortness of breath, cough
Slovenian: • zasoplost, kašelj
English: • Rifampicin (antibiotic used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Slovenian: • rifampicin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
English: SOF+RBV 12 weeks (n = 73)
Slovenian: SOF+RBV 12 tednov (n = 73)
English: SOF+RBV 12 weeks (n = 64)
Slovenian: SOF+RBV 12 tednov (n = 64)
English: Table 13: Response rates in study FUSION
Slovenian: Preglednica 13: Stopnje odziva v študiji FUSION SOF+RBV
English: SOF+RBV 12 weeks (n = 39)
Slovenian: SOF+RBV 12 tednov (n = 39)
English: GS-331007 ↔ Cmax 1.23 (1.14, 1.34) ↔ AUC 0.95 (0.88, 1.03) Cmin (NA)
Slovenian: GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12) Cmin (n/n)
English: Overallc
Slovenian: Emtricitabin
English: Tablet core:
Slovenian: Bolezni prebavil:
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13) Cmin (NA)
Slovenian: ↔ Cmax 0,97 (0,83; 1,14) ↔ AUC 1,00 (0,87; 1,13) Cmin (n/n)
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA)
Slovenian: ↓ AUC 0,28 (0,24; 0,32) Cmin (n/n)
English: Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Slovenian: ↓ Cmax 0,60 (0,53; 0,69)
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30) Cmin (NA)
Slovenian: ↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30) Cmin (n/n)
English: Tenofovir ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91, 1.05) ↔ Cmin 0.99 (0.91, 1.07)
Slovenian: ↔ AUC 0,98 (0,91; 1,05) ↔ Cmin 0,99 (0,91; 1,07)
English: 20% had cirrhosis; 72% had HCV genotype 3.
Slovenian: HCV ob izhodišču je bila 6,4 log10 i.e./ml; 21 % jih je imelo cirozo; 78 % jih je imelo HCV
English: Genotype Genotype 1
Slovenian: Genotip Genotip 1
English: No dose adjustment of sofosbuvir or efavirenz is required when sofosbuvir and efavirenz are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in efavirenza odmerka sofosbuvirja ali efavirenza ni treba prilagajati.
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.
Slovenian: Mediana starost zdravljenih bolnikov (n = 419) je bila 51 let (razpon: 19 do 74); 60 % bolnikov je bilo moških; mediani indeks telesne mase je bil 25 kg/m2 (razpon: 17 do 44 kg/m2); povprečna raven RNA
English: ↔ AUC 1.03 (0.95, 1.12)
Slovenian: ↔ Cmin 0,95 (0,81; 1,12)
English: Mild RI
Slovenian: Stopnja SVR
English: R-methadone ↔ Cmax 0.99 (0.85, 1.16) ↔ AUC 1.01 (0.85, 1.21) ↔ Cmin 0.94 (0.77, 1.14)
Slovenian: ↔ AUC 1,01 (0,85; 1,21) ↔ Cmin 0,94 (0,77; 1,14)
English: Table 17: Response rates in study PHOTON-1
Slovenian: Preglednica 17: Stopnje odziva v študiji PHOTON-1 Genotip 2/3 predhodno nezdravljeni
English: General disorders and administration site conditions: Very common fatigue, irritability chills, fatigue, influenza-like illness, irritability, pain, pyrexia
Slovenian: zelo pogosti navzea driska, navzea, bruhanje pogosti nelagodje v trebuhu, konstipacija,
English: Treatment-naïve and co-infected with HIV (PHOTON-1)
Slovenian: Predhodno nezdravljeni s sočasno okužbo s HIV
English: Treatment-naïve (NEUTRINO)
Slovenian: (NEUTRINO)
English: Cirrhosis
Slovenian: Efavirenz
English: Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Slovenian: Tel: + + 353 (0) 1 686 1888
English: Outcome for patients without SVR12 On-treatment virologic failure Relapseb
Slovenian: Virološki neuspeh med zdravljenjem Relapsa
English: Genotype 2/3 treatment-experienced SOF+RBV
Slovenian: Preglednica 7: Stopnje odziva v študiji NEUTRINO SOF+PEG+RBV
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
Slovenian: Efavirenzf (600 mg enkrat na dan)d
English: Patients with Renal Impairment
Slovenian: Neodzivni bolniki
English: and <50 mL/min/1.73 m2)
Slovenian: (eGFR ml/min/1, 73 m2)
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing-regimes are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Slovenian: Pri uporabi režimov zdravljenja, ki vključujejo sofosobuvir v kombinaciji z amiodaronom in/ali drugimi zdravili, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka
English: Table 12: SVR12 rates for selected subgroups by genotype in POSITRON
Slovenian: Preglednica 12: Stopnje SVR12 za izbrane podskupine po genotipu v študiji POSITRON SOF+RBV 12 tednov
English: Severe RI (eGFR <30 mL/min/1.7 3m2)
Slovenian: (eGFR < ml/min/1,7
English: SOF+RBV 24 weeks TE (n = 13)
Slovenian: SOF+RBV 24 tednov predhodno zdravljeni (n = 13)
English: What should I do?
Slovenian: Kaj naj naredim?
English: • Take your time.
Slovenian: • Vzemite si čas.
English: What's inside
Slovenian: Kaj je notri
English: You will need it later.
Slovenian: Potrebovali jo boste kasneje.
English: Where is the needle?
Slovenian: Kje je igla?
English: • You may need to tap 80 times or more.
Slovenian: • Morda boste morali potrkati 80-krat ali še večkrat.
English: This is also normal.
Slovenian: Tudi to je normalno.
English: • You will need enough time to complete all the steps without stopping.
Slovenian: • Potrebovali boste dovolj časa, da izvedete vse korake brez prekinitve.
English: Pay attention to the bottom surface.
Slovenian: Bodite pozorni na spodnjo površino.
English: Date of first authorisation: 17 June 2011
Slovenian: Datum prve odobritve: 17. junij 2011
English: 1b Wash your hands.
Slovenian: 1b Umijte si roke.
English: 24-Week Study
Slovenian: 24-tedenska študija
English: Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Slovenian: Prosimo, imejte to možno težavo v mislih v vseh situacijah, v katerih lahko sebe ali druge izpostavite tveganju (npr. vožnja avtomobila ali upravljanje strojev).
English: Date of first authorisation: 17 June 2011 Date of latest renewal: 18 February 2016
Slovenian: Datum prve odobritve: 17. junij 2011 Datum zadnjega podaljšanja: 18. februar 2016
English: A. Inject and hold:
Slovenian: A. Injicirajte in držite:
English: • You may need to turn the cap a few times before it loosens (if you hear clicking you are turning in the wrong direction).
Slovenian: • Pokrovček boste morda morali nekajkrat obrniti, preden se bo sprostil (če slišite klikanje, ga obračate v napačno smer).
English: (This question relates to the steps shown in sections 3a to 3d).
Slovenian: (To vprašanje je povezano s koraki, prikazanimi v poglavjih 3a do 3d).
English: I am at step 4c.
Slovenian: Sem pri koraku 4c.
English: Each week you can use the same area of your body.
Slovenian: Vsak teden lahko uporabite isti del telesa.
English: If your question is about:
Slovenian: Če imate vprašanje o:
English: C. Wash your hands.
Slovenian: C. Umijte si roke.
English: Do not give this medicine to children and adolescents less than 18 years, as there is no experience with this medicine in this age group.
Slovenian: Tega zdravila ne dajajte otrokom ali mladostnikom, mlajšim od 18 let, ker z njim v tej starostni skupini ni izkušenj.
English: After a standard meal tolerance test.
Slovenian: Po tolerančnem testu s standardnim obrokom.
English: Read the next steps carefully and look closely at the pictures.
Slovenian: Previdno preberite naslednje korake in si dobro oglejte sličice.
English: If you need to give yourself both at the same time, use two separate injections.
Slovenian: Če si ju morate dati hkrati, uporabite dve ločeni injekcijski brizgi.
English: For more information, please see Figure N in Step 3B in the Instructions for the User.
Slovenian: Za več informacij glejte sliko N v koraku 3B v navodilih za uporabnika.
English: • is large enough to hold the entire pen,
Slovenian: • je dovolj velik, da drži celoten peresnik,
English: You do not have to save any parts.
Slovenian: Ni vam potrebno shraniti nobenega od delov.
English: 80 times or more
Slovenian: 80- ali večkrat
English: Approximately 62% of the patients were male.
Slovenian: Približno 62 % bolnikov je bilo moških.
English: Last Observation Carried Forward (LOCF).
Slovenian: Prenos zadnjega opažanja (LOCF - Last Observation Carried Forward).
English: The needle is now prepared.
Slovenian: Igla je sedaj pripravljena.
English: Before your next injection in 1 week, carefully review the instructions for steps 3a to 4h.
Slovenian: Pred naslednjim injiciranjem čez teden dni previdno preberite navodila za korake 3a do 4h.
English: Put it down for later.
Slovenian: Odložite jo za kasneje.
English: All randomised patients who received at least one dose of study medication.
Slovenian: Vsi randomizirani bolniki, ki so prejeli vsaj en odmerek raziskovanega zdravila.
English: STOP when you hear the click and the green label disappears.
Slovenian: USTAVITE SE, ko zaslišite klik in zelena nalepka izgine.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Slovenian: Podatki, ki so trenutno na voljo, so opisani v poglavju 5.2, a priporočil za odmerjanje ni mogoče dati.
English: • Follow these instructions step by step.
Slovenian: • Sledite navodilom korak za korakom.
English: When it is time for your next weekly dose, start again at step 1.
Slovenian: Ko je čas za vaš naslednji odmerek, ponovno začnite pri koraku 1.
English: • is properly labelled to warn of hazardous waste inside the container.
Slovenian: • je ustrezno označen z opozorilom, da vsebuje nevarne odpadke.
English: (This question relates to step 4a.)
Slovenian: (To vprašanje je povezano s korakom 4a.)
English: This guide is divided into sections:
Slovenian: Ta vodič je razdeljen v poglavja:
English: • You will probably need less time as you get used to giving yourself injections.
Slovenian: • Sčasoma boste potrebovali manj časa, saj se boste navadili na injiciranje.
English: This means the needle has become clogged.
Slovenian: To pomeni, da se je igla zamašila.
English: When you remove the cover, you may see 1 or 2 drops of liquid.
Slovenian: Ko odstranite pokrovček, boste morda opazili eno ali dve kapljici tekočine.
English: This medicine may reduce your appetite, the amount of food you eat, and your weight.
Slovenian: To zdravilo lahko zmanjša vaš apetit, količino hrane, ki jo zaužijete in vašo telesno maso.
English: The safety and efficacy of prolonged-release exenatide in children and adolescents aged under 18 years have not yet been established.
Slovenian: Varnosti in učinkovitosti eksenatida v obliki s podaljšanim sproščanjem pri otrocih in mladostnikih, mlajših od 18 let, še niso ugotovili.
English: For more information on injection techniques talk with your health care professional.
Slovenian: Za več informacij o tehniki injiciranja se pogovorite z vašim zdravstvenim delavcem.
English: This means the medicine is not mixed evenly.
Slovenian: To pomeni, da zdravilo ni enakomerno premešano.
English: Weight loss of this rate may have harmful consequences.
Slovenian: Takšna izguba telesne mase ima lahko škodljive posledice.
English: The medicine can still be fully mixed but it will take more shaking and more time.
Slovenian: Zdravilo je sicer še vedno mogoče popolnoma premešati, vendar bo to zahtevalo več stresanja in več časa.
English: Do not skip steps.
Slovenian: Ne preskakujte korakov.
English: The difference between the two treatment groups was not significant.
Slovenian: Razlika med obema zdravljenjema ni bila signifikantna.
English: Once weekly
Slovenian: enkrat tedensko
English: You should inject this medicine once a week, at any time of day, with or without meals.
Slovenian: To zdravilo si injicirajte enkrat tedensko kadarkoli tekom dneva, s hrano ali brez nje.
English: It is not known if this medicine may harm your unborn child, therefore you should not use it during pregnancy and for at least 3 months before a planned pregnancy.
Slovenian: Ni znano, ali to zdravilo lahko škoduje nerojenemu otroku, zato ga ne smete uporabljati med nosečnostjo ali manj kot 3 mesece pred načrtovano nosečnostjo.
English: Your step by step guide
Slovenian: Vaš vodič korak za korakom
English: To review how to:
Slovenian: Za ponovitev, kako:
English: After you receive your injection, you will see an orange rod in the window.
Slovenian: Potem ko ste prejeli injekcijo, boste v okencu videli oranžno paličico.
English: These pharmacokinetic characteristics of exenatide are independent of the dose.
Slovenian: Te farmakokinetične značilnosti eksenatida so neodvisne od odmerka.
English: Safety findings at 156 weeks were consistent with those reported at 26 weeks.
Slovenian: Ugotovitve o varnosti po 156 tednih so bile skladne s tistimi, ki so bile poročane po 26 tednih.
English: To take the correct dose, read each section so that you do every step in order.
Slovenian: Da boste vzeli pravilen odmerek, previdno preberite vsako poglavje, tako da boste vse korake izvedli v pravilnem zaporedju.
English: If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection.
Slovenian: Če je bil vrh bata pritisnjen preko črte, nadaljujte s korakom 4d in dajte injekcijo.
English: Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.
Slovenian: Glejte Navodilo za uporabo (poglavje 3), kaj narediti v primeru, če niste prepričani, ali ste prejeli celotni odmerek.
English: Read and follow each step in these instructions carefully every time you take Bydureon.
Slovenian: Previdno preberite in sledite vsakemu koraku teh navodil vsakokrat, ko vzamete zdravilo Bydureon.
English: You should see your doctor immediately if you experience symptoms such as
Slovenian: Takoj se obrnite na zdravnika, če imate simptome kot so:
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Slovenian: V primeru prevelikega odmerjanja je potrebno začeti z ustreznim podpornim zdravljenjem glede na bolnikove klinične znake in simptome.
English: • Bydureon BCise pen should not be used by people who are blind or cannot see well, unless another person who is trained to use this device can help.
Slovenian: • Peresnika Bydureon BCise ne smejo uporabljati slepe ali slabovidne osebe, razen če jim lahko pomaga druga oseba, usposobljena za uporabo tega pripomočka.