natgillin/translations-raw huggingface dataset:
Co-administration of Sovaldi with modafinil is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Sovaldi z modafinilom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
No dose adjustment of sofosbuvir or raltegravir is required when sofosbuvir and raltegravir are used concomitantly.
Pri sočasni uporabi sofosbuvirja in raltegravirja odmerka sofosbuvirja ali raltegravirja ni treba prilagajati.
Table 9: Response rates in study FISSION
Preglednica 9: Stopnje odziva v študiji FISSION SOF+RBV
The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 adult patients with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve patients with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in patients with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve patients, one in interferon intolerant, ineligible or unwilling patients, one in patients previously treated with an interferon-based regimen, and one in all patients irrespective of prior treatment history or ability to receive treatment with interferon.
Druge štiri študije pa so opravili pri bolnikih s kroničnim hepatitisom C genotipa 2 ali 3 v kombinaciji z ribavirinom, in sicer eno študijo z bolniki, ki se predhodno še niso zdravili, eno študijo z bolniki, ki niso prenašali interferona ali za zdravljenje z njim niso bile primerni ali voljni, eno študijo z bolniki, ki so bili predhodno zdravljeni z režimom na podlagi interferona, in eno študijo z vsemi bolniki, ne glede na predhodno anamnezo zdravljenja ali zmožnost zdravljenja z interferonom.
Until liver transplantationc
Do presaditve jeterc
FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 2 or 3 HCV infection.
Odrasli, ki se predhodno še niso zdravili - FISSION (študija 1231) Študija FISSION je bila randomizirana, odprta, z aktivno učinkovino kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom v primerjavi s 24-tedenskim zdravljenjem s peginterferonom alfa 2a in ribavirinom za zdravljenje bolnikov, ki se predhodno še niso zdravili, z okužbo s HCV genotipa 2 ali 3.
No dose adjustment of Sovaldi is required when concomitantly used with rifabutin.
Pri sočasni uporabi z rifabutinom odmerka zdravila Sovaldi ni treba prilagajati.
No dose adjustment of sofosbuvir or ciclosporin is required at initiation of co-administration.
Odmerka sofosbuvirja ali ciklosporina ob uvedbi sočasnega dajanja ni treba prilagajati.
Co-administration with other direct-acting antivirals against HCV
Sočasno dajanje z drugimi zdravili proti HCV z direktnim delovanjem na viruse
SOF+RBV 12 weeks (n = 183)
SOF+RBV 12 tednov (n = 183)
No dose adjustment of sofosbuvir or tacrolimus is required at initiation of co-administration.
Odmerka sofosbuvirja ali takrolimusa ob uvedbi sočasnega dajanja ni treba prilagajati.
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf (400 mg twice daily)
Raltegravirf (400 mg dvakrat na dan)
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).
a. Glejte preglednico 4 za priporočila o odmerjanju ribavirina na podlagi telesne mase b. Razmisliti je treba o možnem podaljšanju trajanja zdravljenja 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 (npr. napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28B, predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom).
PEG+RBV 24 weeks (n = 67)
PEG+RBV 24 tednov (n = 67)
Sofosbuvir was administered at a dose of 400 mg once daily.
Sofosbuvir so dajali v odmerku 400 mg enkrat na dan. Odmerek ribavirina je bil določen na podlagi telesne mase in je znašal
The exposure to GS-331007 was not altered in the presence of a high-fat meal.
Prisotnost obroka z visoko vsebnostjo maščobe ni spremenila izpostavljenosti presnovku GS-331007.
Treatment-experienced co-infected with HIV (PHOTON-1)
Predhodno zdravljeni s sočasno okužbo s HIV
Rilpivirine ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04)
↔ Cmax 1,05 (0,97; 1,15) ↔ AUC 1,06 (1,02; 1,09)
Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA)
↓ AUC 0,52 (0,46; 0,59) Cmin (n/n)
Genotype 2/3 treatment-naïve SOF+RBV 12 weeks (n = 68)
Genotip 2/3 predhodno zdravljeni SOF+RBV 24 tednov (n = 28)
Intolerant
ANALEPTIKI
Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08) ↔ AUC 0.95 (0.82, 1.09) Cmin (NA)
↔ Cmax 0,87 (0,71; 1,08) ↔ AUC 0,95 (0,82; 1,09) Cmin (n/n)
Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, 1.40) Cmin (NA)
↓ Cmax 0,73 (0,59; 0,90) ↔ AUC 1,09 (0,84; 1,40) Cmin (n/n)
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).
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).
Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
Preglednica 20: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 1
SOF+RBV 12 weeks
SOF+RBV 12 tednov
SOF+RBV 12 weeks (n = 73)a
SOF+RBV 12 tednov (n = 73)a
Emtricitabine ↔ Cmax 0.97 (0.88, 1.07) ↔ AUC 0.99 (0.94, 1.05) ↔ Cmin 1.04 (0.98, 1.11)
↔ Cmax 0,97 (0,88; 1,07) ↔ AUC 0,99 (0,94; 1,05)
Overall Genotype 1a Genotype 1b No cirrhosis Cirrhosis
Skupaj Genotip 1a Genotip 1b
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.
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.
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.
50 bolnikov, zdravljenih z zdravilom Sovaldi in ribavirinom 12 tednov (bolniki z genotipom 2) oz.
Norgestromin ↔ Cmax 1.06 (0.93, 1.22)
↔ Cmax 1,06 (0,93; 1,22)
↔ AUC 1.19 (0.98, 1.44)
↔ AUC 1,19 (0,98; 1,44) Cmin (n/n)
ANALEPTICS Modafinil
Modafinil
Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Preglednica 21: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 2
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.
V naslednjih preglednicah (preglednica 20 do preglednice 23) so predstavljeni podatki študij 2. faze in
Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Sovaldi z okskarbazepinom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
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.
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.
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.
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.
SOF+RBV 16 weeks (n = 35)
SOF+RBV 16 tednov (n = 35)
Table 22: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Preglednica 22: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 3
Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12)
↓ Cmax 0,57 (0,44; 0,75) ↓ AUC 0,73 (0,59; 0,91)
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).
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,
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;
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.
SOF+RBV 12 weeks (n = 11)
SOF+RBV 12 tednov (n = 11)
↔ AUC 1.08 (0.93, 1.25)
↔ AUC 1,04c (0,89; 1,22)
↔ AUC 1.05 (0.92, 1.20)
↔ AUC 1,05 (0,92; 1,20) Cmin (n/n)
Response rates for patients with cirrhosis at baseline are presented in Table 10 by HCV genotype.
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
Overall No cirrhosis
Brez ciroze Ciroza
No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly.
Pri sočasni uporabi sofosbuvirja in dizoproksiltenofovirata odmerka sofosbuvirja ali dizoproksiltenofovirata ni treba prilagajati.
SOF+RBV 16 weeks (n = 63)
SOF+RBV 16 tednov (n = 63)
Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders:
Infekcijske in parazitske bolezni:
• shortness of breath, cough
• zasoplost, kašelj
• Rifampicin (antibiotic used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
• rifampicin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
SOF+RBV 12 weeks (n = 73)
SOF+RBV 12 tednov (n = 73)
SOF+RBV 12 weeks (n = 64)
SOF+RBV 12 tednov (n = 64)
Table 13: Response rates in study FUSION
Preglednica 13: Stopnje odziva v študiji FUSION SOF+RBV
SOF+RBV 12 weeks (n = 39)
SOF+RBV 12 tednov (n = 39)
GS-331007 ↔ Cmax 1.23 (1.14, 1.34) ↔ AUC 0.95 (0.88, 1.03) Cmin (NA)
GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12) Cmin (n/n)
Tablet core:
Bolezni prebavil:
GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13) Cmin (NA)
↔ Cmax 0,97 (0,83; 1,14) ↔ AUC 1,00 (0,87; 1,13) Cmin (n/n)
Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA)
↓ AUC 0,28 (0,24; 0,32) Cmin (n/n)
Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
↓ Cmax 0,60 (0,53; 0,69)
GS-331007 ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30) Cmin (NA)
↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30) Cmin (n/n)
Tenofovir ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91, 1.05) ↔ Cmin 0.99 (0.91, 1.07)
↔ AUC 0,98 (0,91; 1,05) ↔ Cmin 0,99 (0,91; 1,07)
20% had cirrhosis; 72% had HCV genotype 3.
HCV ob izhodišču je bila 6,4 log10 i.e./ml; 21 % jih je imelo cirozo; 78 % jih je imelo HCV
No dose adjustment of sofosbuvir or efavirenz is required when sofosbuvir and efavirenz are used concomitantly.
Pri sočasni uporabi sofosbuvirja in efavirenza odmerka sofosbuvirja ali efavirenza ni treba prilagajati.
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.
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
↔ AUC 1.03 (0.95, 1.12)
↔ Cmin 0,95 (0,81; 1,12)
Mild RI
Stopnja SVR
R-methadone ↔ Cmax 0.99 (0.85, 1.16) ↔ AUC 1.01 (0.85, 1.21) ↔ Cmin 0.94 (0.77, 1.14)
↔ AUC 1,01 (0,85; 1,21) ↔ Cmin 0,94 (0,77; 1,14)
Table 17: Response rates in study PHOTON-1
Preglednica 17: Stopnje odziva v študiji PHOTON-1 Genotip 2/3 predhodno nezdravljeni
General disorders and administration site conditions: Very common fatigue, irritability chills, fatigue, influenza-like illness, irritability, pain, pyrexia
zelo pogosti navzea driska, navzea, bruhanje pogosti nelagodje v trebuhu, konstipacija,
Treatment-naïve and co-infected with HIV (PHOTON-1)
Predhodno nezdravljeni s sočasno okužbo s HIV
Outcome for patients without SVR12 On-treatment virologic failure Relapseb
Virološki neuspeh med zdravljenjem Relapsa
Genotype 2/3 treatment-experienced SOF+RBV
Preglednica 7: Stopnje odziva v študiji NEUTRINO SOF+PEG+RBV
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
Efavirenzf (600 mg enkrat na dan)d
Patients with Renal Impairment
Neodzivni bolniki
and <50 mL/min/1.73 m2)
(eGFR ml/min/1, 73 m2)
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).
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
Table 12: SVR12 rates for selected subgroups by genotype in POSITRON
Preglednica 12: Stopnje SVR12 za izbrane podskupine po genotipu v študiji POSITRON SOF+RBV 12 tednov
Severe RI (eGFR <30 mL/min/1.7 3m2)
(eGFR < ml/min/1,7
SOF+RBV 24 weeks TE (n = 13)
SOF+RBV 24 tednov predhodno zdravljeni (n = 13)
What should I do?
Kaj naj naredim?
• Take your time.
• Vzemite si čas.
What's inside
Kaj je notri
You will need it later.
Potrebovali jo boste kasneje.
Where is the needle?
Kje je igla?
• You may need to tap 80 times or more.
• Morda boste morali potrkati 80-krat ali še večkrat.
This is also normal.
Tudi to je normalno.
• You will need enough time to complete all the steps without stopping.
• Potrebovali boste dovolj časa, da izvedete vse korake brez prekinitve.
Pay attention to the bottom surface.
Bodite pozorni na spodnjo površino.
Date of first authorisation: 17 June 2011
Datum prve odobritve: 17. junij 2011
1b Wash your hands.
1b Umijte si roke.
24-Week Study
24-tedenska študija
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).
Prosimo, imejte to možno težavo v mislih v vseh situacijah, v katerih lahko sebe ali druge izpostavite tveganju (npr. vožnja avtomobila ali upravljanje strojev).
Date of first authorisation: 17 June 2011 Date of latest renewal: 18 February 2016
Datum prve odobritve: 17. junij 2011 Datum zadnjega podaljšanja: 18. februar 2016
A. Inject and hold:
A. Injicirajte in držite:
• You may need to turn the cap a few times before it loosens (if you hear clicking you are turning in the wrong direction).
• Pokrovček boste morda morali nekajkrat obrniti, preden se bo sprostil (če slišite klikanje, ga obračate v napačno smer).
(This question relates to the steps shown in sections 3a to 3d).
(To vprašanje je povezano s koraki, prikazanimi v poglavjih 3a do 3d).
I am at step 4c.
Sem pri koraku 4c.
Each week you can use the same area of your body.
Vsak teden lahko uporabite isti del telesa.
If your question is about:
Če imate vprašanje o:
C. Wash your hands.
C. Umijte si roke.
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.
Tega zdravila ne dajajte otrokom ali mladostnikom, mlajšim od 18 let, ker z njim v tej starostni skupini ni izkušenj.
After a standard meal tolerance test.
Po tolerančnem testu s standardnim obrokom.
Read the next steps carefully and look closely at the pictures.
Previdno preberite naslednje korake in si dobro oglejte sličice.
If you need to give yourself both at the same time, use two separate injections.
Če si ju morate dati hkrati, uporabite dve ločeni injekcijski brizgi.
For more information, please see Figure N in Step 3B in the Instructions for the User.
Za več informacij glejte sliko N v koraku 3B v navodilih za uporabnika.
• is large enough to hold the entire pen,
• je dovolj velik, da drži celoten peresnik,
You do not have to save any parts.
Ni vam potrebno shraniti nobenega od delov.
80 times or more
80- ali večkrat
Approximately 62% of the patients were male.
Približno 62 % bolnikov je bilo moških.
Last Observation Carried Forward (LOCF).
Prenos zadnjega opažanja (LOCF - Last Observation Carried Forward).
The needle is now prepared.
Igla je sedaj pripravljena.
Before your next injection in 1 week, carefully review the instructions for steps 3a to 4h.
Pred naslednjim injiciranjem čez teden dni previdno preberite navodila za korake 3a do 4h.
Put it down for later.
Odložite jo za kasneje.
All randomised patients who received at least one dose of study medication.
Vsi randomizirani bolniki, ki so prejeli vsaj en odmerek raziskovanega zdravila.
STOP when you hear the click and the green label disappears.
USTAVITE SE, ko zaslišite klik in zelena nalepka izgine.
Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Podatki, ki so trenutno na voljo, so opisani v poglavju 5.2, a priporočil za odmerjanje ni mogoče dati.
• Follow these instructions step by step.
• Sledite navodilom korak za korakom.
When it is time for your next weekly dose, start again at step 1.
Ko je čas za vaš naslednji odmerek, ponovno začnite pri koraku 1.
• is properly labelled to warn of hazardous waste inside the container.
• je ustrezno označen z opozorilom, da vsebuje nevarne odpadke.
(This question relates to step 4a.)
(To vprašanje je povezano s korakom 4a.)
This guide is divided into sections:
Ta vodič je razdeljen v poglavja:
• You will probably need less time as you get used to giving yourself injections.
• Sčasoma boste potrebovali manj časa, saj se boste navadili na injiciranje.
This means the needle has become clogged.
To pomeni, da se je igla zamašila.
When you remove the cover, you may see 1 or 2 drops of liquid.
Ko odstranite pokrovček, boste morda opazili eno ali dve kapljici tekočine.
This medicine may reduce your appetite, the amount of food you eat, and your weight.
To zdravilo lahko zmanjša vaš apetit, količino hrane, ki jo zaužijete in vašo telesno maso.
The safety and efficacy of prolonged-release exenatide in children and adolescents aged under 18 years have not yet been established.
Varnosti in učinkovitosti eksenatida v obliki s podaljšanim sproščanjem pri otrocih in mladostnikih, mlajših od 18 let, še niso ugotovili.
For more information on injection techniques talk with your health care professional.
Za več informacij o tehniki injiciranja se pogovorite z vašim zdravstvenim delavcem.
This means the medicine is not mixed evenly.
To pomeni, da zdravilo ni enakomerno premešano.
Weight loss of this rate may have harmful consequences.
Takšna izguba telesne mase ima lahko škodljive posledice.
The medicine can still be fully mixed but it will take more shaking and more time.
Zdravilo je sicer še vedno mogoče popolnoma premešati, vendar bo to zahtevalo več stresanja in več časa.
Do not skip steps.
Ne preskakujte korakov.
The difference between the two treatment groups was not significant.
Razlika med obema zdravljenjema ni bila signifikantna.
Once weekly
enkrat tedensko
You should inject this medicine once a week, at any time of day, with or without meals.
To zdravilo si injicirajte enkrat tedensko kadarkoli tekom dneva, s hrano ali brez nje.
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.
Ni znano, ali to zdravilo lahko škoduje nerojenemu otroku, zato ga ne smete uporabljati med nosečnostjo ali manj kot 3 mesece pred načrtovano nosečnostjo.
Your step by step guide
Vaš vodič korak za korakom
To review how to:
Za ponovitev, kako:
After you receive your injection, you will see an orange rod in the window.
Potem ko ste prejeli injekcijo, boste v okencu videli oranžno paličico.
These pharmacokinetic characteristics of exenatide are independent of the dose.
Te farmakokinetične značilnosti eksenatida so neodvisne od odmerka.
Safety findings at 156 weeks were consistent with those reported at 26 weeks.
Ugotovitve o varnosti po 156 tednih so bile skladne s tistimi, ki so bile poročane po 26 tednih.
To take the correct dose, read each section so that you do every step in order.
Da boste vzeli pravilen odmerek, previdno preberite vsako poglavje, tako da boste vse korake izvedli v pravilnem zaporedju.