FrancophonIA/ELRC3.0 huggingface dataset:
English: Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected patients in the Phase 3 clinical studies.
Croatian: U kliničkim ispitivanjima faze 3 su u uzorcima više bolesnika zaraženih genotipom 3 HCV­a s relapsom nakon liječenja bile otkrivene dvije NS5B supstitucije, L159F i V321A.
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA)
Croatian: ↓ Cmax 0,23 (0,19; 0,29) ↓ AUC 0,28 (0,24; 0,32) Cmin (ND/NP)
English: Efavirenz ↔ Cmax 0.95 (0.85, 1.06) ↔ AUC 0.96 (0.91, 1.03) ↔ Cmin 0.96 (0.93, 0.98)
Croatian: ↔ Cmax 0,95 (0,85; 1,06) ↔ AUC 0,96 (0,91; 1,03) ↔ Cmin 0,96 (0,93; 0,98)
English: Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, 1.27) Cmin (NA)
Croatian: ↑ Cmax 1,21 (0,90; 1,62) ↔ AUC 1,09 (0,94; 1,27) Cmin (NA)
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
Croatian: ↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57) Cmin (ND/NP)
English: b. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Croatian: b. Nazivnik za relaps je broj bolesnika s HCV RNK < donje granice kvantifikacije na njihovom posljednjem pregledu za vrijeme trajanja terapije.
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.
Croatian: Medijan dobi liječenih bolesnika (n = 419) bio je 51 godina (raspon: 19 do 74); 60% bolesnika bili su muškarci; medijan indeksa tjelesne mase iznosio je 25 kg/m2 (raspon: 17 do 44 kg/m2); srednja vrijednost početne razine HCV RNK bila je 6,4 log10 IU/ml; 21% imalo je cirozu; 78% imalo je HCV­genotip 3; 65% je prethodno imalo relaps.
English: SOF+RBV 16 weeks (n = 98)a
Croatian: SOF+RBV 16 tjedana (n = 98)a
English: Overall Genotype 1a Genotype 1b No cirrhosis Cirrhosis
Croatian: Ukupnoc Genotip 1ac Genotip 1bc Bez cirozec
English: Rilpivirine ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04)
Croatian: ↔ Cmax 1,05 (0,97; 1,15) ↔ AUC 1,06 (1,02; 1,09) ↔ Cmin 0,99 (0,94; 1,04)
English: PEG+RBV 24 weeks (n = 67)
Croatian: PEG+RBV 24 tjedna (n = 67)
English: Adults The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).
Croatian: Preporučena doza je jedna tableta od 400 mg, koja se uzima peroralno jedanput na dan s hranom
English: Of the 50 treated patients, the median age was 15 years (range: 12 to 17); 42% of the patients were female; 90% were White, 4% were Black, and 2% were Asian; 4% were Hispanic/Latino; mean body mass index was 22 kg/m2 (range: 16 to 32 kg/m2); 18% were treatment experienced; 66% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 74% of patients had non-CC IL28B alleles (CT or TT); and no patients had known cirrhosis.
Croatian: U tih 50 liječenih bolesnika, medijan dobi iznosio je 15 godina (raspon: od 12 do 17); 42% bolesnika bile su žene, 90% bili su bijelci, 4% crnci i 2% Azijci; 4% bili su hispano­ ili latino porijekla; srednja vrijednost indeksa tjelesne mase bila je 22 kg/m2 (raspon: od 16 do 32 kg/m2); 18% bilo je prethodno liječeno; 66% imalo je početne razine HCV RNK više ili jednake 800 000 IU/ml; 74% bolesnika imalo je ne­CC IL28B alele (CT ili TT) te nijedan bolesnik nije imao utvrđenu cirozu.
English: Patients with Renal Impairment
Croatian: Bolesnici s oštećenjem bubrega
English: Table 11: Response rates in study POSITRON
Croatian: Tablica 11: Stope odgovora u ispitivanju POSITRON SOF+RBV
English: Table 18: SVR12 rates for selected subgroups by genotype in study PHOTON-1
Croatian: Tablica 18 prikazuje analizu prisutnosti ciroze u podskupinama prema genotipu Tablica 18: Stope SVR12 za odabrane podskupine prema genotipu u ispitivanju PHOTON-1
English: Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Croatian: Očekuje se da će istodobna primjena Sovaldija s okskarbazepinom smanjiti koncentraciju sofosbuvira i tako dovesti do smanjenog terapijskog učinka Sovaldija.
English: Patients with HCV genotype 2 or 3 infection in the trial were treated with sofosbuvir with ribavirin for 12 or 24 weeks, respectively.
Croatian: Bolesnici zaraženi HCV­om genotipa 2 u kliničkom su ispitivanju liječeni sofosbuvirom s ribavirinom tijekom 12 tjedana, a oni zaraženi HCV­om genotipa 3 liječeni su tijekom 24 tjedna.
English: SOF+RBV 12 weeks (n = 183)
Croatian: SOF+RBV 12 tjedana (n = 183)
English: No dose adjustment of sofosbuvir or tacrolimus is required at initiation of co-administration.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili takrolimusa na početku istodobne primjene.
English: Dialysis
Croatian: Doziranje
English: SOF+RBV 12 weeks
Croatian: SOF+RBV 12 tjedana
English: No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili tenofovirdizoproksila kad se sofosbuvir i tenofovirdizoproksil primjenjuju istodobno.
English: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18) ↔ AUC 0.98 (0.85, 1.14) Cmin (NA)
Croatian: ↔ Cmax 1,06 (0,94; 1,18) ↔ AUC 0,98 (0,85; 1,14) Cmin (ND/NP)
English: • fainting
Croatian: ● nesvjesticu
English: R-methadone ↔ Cmax 0.99 (0.85, 1.16) ↔ AUC 1.01 (0.85, 1.21) ↔ Cmin 0.94 (0.77, 1.14)
Croatian: ↔ Cmax 0,99 (0,85; 1,16) ↔ AUC 1,01 (0,85; 1,21) ↔ Cmin 0,94 (0,77; 1,14)
English: The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Croatian: Farmakokinetička svojstva sofosbuvira i glavnog cirkulirajućeg metabolita GS­331007 ocijenjena su u zdravih odraslih ispitanika i u bolesnika s kroničnim hepatitisom C.
English: SOF+RBV 12 weeks TN (n = 42)
Croatian: SOF+RBV 12 tjedana TN (n = 42)
English: The safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis was also studied in Study 0154.
Croatian: U ispitivanju 0154 procijenjene su također sigurnost i djelotvornost 12­tjednog liječenja ledipasvirom/sofosbuvirom u 18 bolesnika zaraženih HCV­om genotipa 1 i teškim oštećenjem bubrega koje nije zahtijevalo dijalizu.
English: SOF+RBV 12 weeks (n = 73)a
Croatian: SOF+RBV 12 tjedana (n = 73)a
English: SOF+RBV 12 weeks TN (n = 26)
Croatian: SOF+RBV 12 tjedana TN (n = 26)
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.
Croatian: Medijan dobi liječenih bolesnika (n = 278) bio je 54 godine (raspon: 21 do 75); 54% bolesnika bili su muškarci; 91% bili su bijelci, 5% bili su crnci; 11% bili su hispano­ ili latino­porijekla; srednja vrijednost indeksa tjelesne mase bila je 28 kg/m2 (raspon: 18 to 53 kg/m2); 70% imalo je početne razine HCV RNK veće od 6 log10 IU/ml; 16% imalo je cirozu; 49% imalo je HCV­genotip 3.
English: • light-headedness
Croatian: ● ošamućenost
English: Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
Croatian: Tablica 20: Ishodi prema terapijskom režimu i trajanju liječenja, usporedba ispitivanja za infekciju genotipom 1 HCV­a
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.
Croatian: Medijan dobi liječenih bolesnika (n = 201) bio je 56 godina (raspon: 24 do 70); 70% bolesnika bili su muškarci; 87% bili su bijelci; 3% bili su crnci; 9% bili su hispano­ ili latino­porijekla; srednja vrijednost indeksa tjelesne mase bila je 29 kg/m2 (raspon: 19 do 44 kg/m2); 73% imalo je početnu razinu HCV RNK veću od 6 log10 IU/ml; 34% imalo je cirozu; 63% imalo je HCV­genotip 3; 75% je prethodno imalo relaps.
English: Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Croatian: Tablica 21: Ishodi prema terapijskom režimu i trajanju liječenja, usporedba ispitivanja za infekciju genotipom 2 HCV­a
English: Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76, 1.16) Cmin (NA)
Croatian: ↓ Cmax 0,81 (0,60; 1,10) ↔ AUC 0,94 (0,76; 1,16) Cmin (ND/NP)
English: • diarrhoea, feeling sick (nausea), being sick (vomiting)
Croatian: ● proljev, mučnina, povraćanje
English: Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08) ↔ AUC 0.95 (0.82, 1.09) Cmin (NA)
Croatian: ↔ Cmax 0,87 (0,71; 1,08) ↔ AUC 0,95 (0,82; 1,09) Cmin (ND/NP)
English: While subject to active tubular secretion, GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or 3, OCT2, MRP2, P-gp, BCRP or MATE1.
Croatian: Sofosbuvir nije supstrat jetrenih prijenosnika za unos tvari, polipeptida za prijenos organskih aniona (OATP) 1B1 ili 1B3 i prijenosnika organskih kationa (OCT) 1. Iako je podložan aktivnoj tubularnoj sekreciji, GS­331007 nije supstrat bubrežnih prijenosnika uključujući prijenosnik organskih aniona (OAT) 1 ili 3, OCT 2, MRP2, P­gp, BCRP ili MATE1.
English: No dose adjustment of sofosbuvir or raltegravir is required when sofosbuvir and raltegravir are used concomitantly.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili raltegravira kad se sofosbuvir i raltegravir primjenjuju istodobno.
English: Based on population pharmacokinetic analysis in patients with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively.
Croatian: HCV­infekcije (n = 986), AUC0­24 za sofosbuvir u stanju dinamičke ravnoteže bio je 1010 ng•h/ml, a za GS­331007 7200 ng•h/ml.
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, 1.40) Cmin (NA)
Croatian: ↓ Cmax 0,73 (0,59; 0,90) ↔ AUC 1,09 (0,84; 1,40) Cmin (ND/NP)
English: SOF+RBV 24 weeks TE (n = 13)
Croatian: SOF+RBV 24 tjedna TE (n = 13)
English: Table 22: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Croatian: Tablica 22: Ishodi prema terapijskom režimu i trajanju liječenja, usporedba ispitivanja za infekciju genotipom 3 HCV­a
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;
Croatian: Medijan dobi liječenih bolesnika (n = 499) bio je 50 godina (raspon: 19 do 77); 66% bolesnika bili su muškarci; 87% bili su bijelci, 3% bili su crnci; 14% bili su hispano­ ili latino­porijekla; srednja vrijednost indeksa tjelesne mase bila je 28 kg/m2 (raspon: 17 do 52 kg/m2); 57% je imalo početnu razinu HCV RNK veću od 6 log10 IU/ml; 20% imalo je cirozu; 72% imalo je HCV genotip 3.
English: • back pain, muscle spasms
Croatian: ● bol u leđima, mišićni grčevi
English: SOF+RBV 12 weeks (n = 11)
Croatian: SOF+RBV 12 tjedana (n = 11)
English: SOF+RBV 16 weeks (n = 35)
Croatian: SOF+RBV 16 tjedana (n = 35)
English: It is important not to miss a dose of this medicine.
Croatian: Ako ste zaboravili uzeti Sovaldi Važno je da ne propustite uzeti dozu ovog lijeka.
English: 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.
Croatian: Klinička ispitivanja u bolesnika s genotipovima 2 i 3 kroničnog hepatitisa C Odrasli koji prethodno nisu bili liječeni - FISSION (ispitivanje 1231) FISSION je bilo randomizirano, otvoreno ispitivanje s aktivnom kontrolom u kojem se procjenjivalo 12 tjedana liječenja sofosbuvirom i ribavirinom u usporedbi s 24 tjedna liječenja peginterferonom alfa 2a i ribavirinom bolesnika koji prethodno nisu bili liječeni i imali su infekciju genotipovima 2 ili 3 HCV­a.
English: Cirrhosis No Yes Response to prior HCV treatment Relapser Nonresponder 70% (7/10)
Croatian: Odgovor na prethodno liječenje HCV­a Relaps Bez odgovora
English: 130 mg/daily])
Croatian: 800 mg/dan
English: SOF+RBV 24 weeks TE (n = 15)
Croatian: SOF+RBV 24 tjedna TE (n = 15)
English: SOF+RBV 16 weeks (n = 63)
Croatian: SOF+RBV 16 tjedana (n = 63)
English: • Rifampicin (antibiotic used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Croatian: ● rifampicin (antibiotik koji se primjenjuje za liječenje infekcija, uključujući tuberkulozu);
English: Table 9: Response rates in study FISSION
Croatian: Table 9: Stope odgovora u ispitivanju FISSION SOF+RBV
English: SOF+RBV 12 weeks (n = 73)
Croatian: SOF+RBV 12 tjedana (n = 73)
English: GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA)
Croatian: ↓ Cmax 0,77 (0,70; 0,84) ↔ AUC 0,84 (0,76; 0,92) Cmin (ND/NP)
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.
Croatian: Medijan dobi liječenih bolesnika (n = 327) bio je 54 godine (raspon: 19 do 70); 64% bolesnika bili su muškarci; 79% bili su bijelci, 17% bili su crnci; 14% bili su hispano ili latino­porijekla; srednja vrijednost indeksa tjelesne mase iznosila je 29 kg/m2 (raspon: 18 do 56 kg/m2); 78% imalo je početni HCV RNK veći od 6 log10 IU/ml; 17% imalo je cirozu; 89% imalo je HCV­genotip 1 i 11% je imalo HCV­genotip 4, 5 ili 6. Tablica 7 prikazuje stope odgovora u terapijskoj skupini koja je primala sofosbuvir + peginterferon alfa + ribavirin.
English: SOF+RBV 12 weeks (n = 64)
Croatian: SOF+RBV 12 tjedana (n = 64)
English: SOF+RBV 12 weeks (n = 39)
Croatian: SOF+RBV 12 tjedana (n = 39)
English: If you are not sure of what medicines can be taken with Sovaldi, talk to your doctor or pharmacist.
Croatian: Obratite se svom liječniku ili ljekarniku ako niste sigurni koje lijekove možete uzimati uz lijek Sovaldi.
English: Table 8: SVR12 rates for selected subgroups in NEUTRINO
Croatian: Table 8: Stope SVR12 za odabrane podskupine u ispitivanju NEUTRINO SOF+PEG+RBV
English: Genotype 2/3 treatment-naïve SOF+RBV 12 weeks (n = 68)
Croatian: Bolesnici s genotipom 2/3 koji su prethodno liječeni SOF+RBV 24 tjedna (n = 28)
English: Tablet core:
Croatian: Poremećaji probavnog sustava:
English: Table 12: SVR12 rates for selected subgroups by genotype in POSITRON
Croatian: Tablica 12: Stope SVR12 u odabranim podskupinama prema genotipu u ispitivanju POSITRON SOF+RBV 12 tjedana
English: • blurred vision
Croatian: ● zamagljen vid
English: Genotype 2/3 treatment-experienced SOF+RBV
Croatian: Bolesnici s genotipom 1 koji prethodno nisu liječeni SOF+RBV
English: Sovaldi is contraindicated with carbamazepine (see section 4.3).
Croatian: Sovaldi je kontraindiciran s karbamazepinom
English: Overallc
Croatian: Genotip
English: Treatment-naïve (FISSION)
Croatian: Bolesnici koji prethodno nisu liječeni (FISSION)
English: Nervous system disorders: Very common headache dizziness, headache
Croatian: Glavobolja omaglica, glavobolja
English: Sovaldi is contraindicated with rifampicin (see section 4.3).
Croatian: Sovaldi je kontraindiciran s rifampicinom
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
Croatian: Efavirenzf (600 mg jedanput na dan)d
English: and <50 mL/min/1.73 m2)
Croatian: Umjereno oštećenje bubrega (eGFR ≥ 30 i < 50 ml/min/ 1,73 m2)
English: ANTICONVULSANTS Phenobarbital Phenytoin
Croatian: Darunavir pojačan ritonaviromf
English: Psychiatric disorders: Very common insomnia insomnia
Croatian: HIV ANTIVIRUSNI LIJEKOVI: INHIBITORI INTEGRAZE
English: GS-331007 ↔ Cmax 1.23 (1.14, 1.34) ↔ AUC 0.95 (0.88, 1.03) Cmin (NA)
Croatian: ↔ Cmax 1,23 (1,14; 1,34) ↔ AUC 0,95 (0,88; 1,03) Cmin (ND/NP)
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.20) ↔ AUC 1.03 (0.97, 1.08) Cmin (NA)
Croatian: ↔ Cmax 1,09 (0,99; 1,20) ↔ AUC 1,03 (0,97; 1,08) Cmin (ND/NP)
English: Cirrhosis
Croatian: Efavirenz
English: Table 7 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Croatian: Tablica 7: Stope odgovora u ispitivanju NEUTRINO SOF+PEG+RBV
English: Intolerant
Croatian: ANALEPTICI
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13) Cmin (NA)
Croatian: ↔ Cmax 0,97 (0,83; 1,14) ↔ AUC 1,00 (0,87; 1,13) Cmin (ND/NP)
English: ↓ AUC 0.76 (0.63, 0.91)
Croatian: ↓ Cmax 0,64 (0,53; 0,77) ↓ AUC 0,76 (0,63; 0,91) Cmin (NA)
English: GS-331007 ↔ Cmax 1.06 (0.99, 1.14) ↔ AUC 1.01 (0.97, 1.04) Cmin (NA)
Croatian: ↔ Cmax 1,06 (0,99; 1,14) ↔ AUC 1,01 (0,97; 1,04) Cmin (ND/NP)
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30) Cmin (NA)
Croatian: ↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30) Cmin (ND/NP)
English: <1/1,000) or very rare (<1/10,000).
Croatian: S cirozom 100% (1/1)
English: Film-coating
Croatian: Okskarbazepin
English: What should I do?
Croatian: Što da učinim?
English: What's inside
Croatian: Što je unutra
English: You will need it later.
Croatian: Trebat će Vam kasnije.
English: 80 times or more
Croatian: 80 puta ili više
English: This is also normal.
Croatian: To je također normalno.
English: • You may need to tap 80 times or more.
Croatian: • Možda ćete morati lupnuti 80 puta ili više.
English: Where is the needle?
Croatian: Gdje je igla?
English: • You will need enough time to complete all the steps without stopping.
Croatian: • Trebat će Vam dovoljno vremena da dovršite sve korake bez prekida.
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).
Croatian: Molimo da imate na umu ovaj mogući problem u svim situacijama u kojima biste mogli ugroziti sebe i druge (npr. vožnja automobila ili rukovanje strojevima).
English: The difference between the two treatment groups was not significant.
Croatian: Razlika između tih dviju liječenih skupina nije bila značajna.
English: If your question is about:
Croatian: Ako se Vaše pitanje odnosi na:
English: • Follow these instructions step by step.
Croatian: • Slijedite ove upute korak po korak.
English: Read the next steps carefully and look closely at the pictures.
Croatian: Pažljivo pročitajte sljedeće korake i dobro pogledajte slike.
English: Date of first authorisation: 17 June 2011
Croatian: Datum prvog odobrenja: 17. lipnja 2011.
English: 1b Wash your hands.
Croatian: 1b Operite ruke.
English: You may see or feel a small bump under the skin after your injection; it should go away after 4 to 8 weeks.
Croatian: Možda ćete vidjeti ili osjetiti malu kvržicu ispod kože nakon injekcije; ona bi trebala nestati nakon 4 do 8 tjedana.
English: After a standard meal tolerance test.
Croatian: Nakon testa tolerancije standardnog obroka.
English: Each week you can use the same area of your body.
Croatian: Svakog tjedna možete koristiti isti dio tijela.
English: I am at step 4c.
Croatian: Ja sam na koraku 4c.
English: This is how the parts should now look when they are connected.
Croatian: Ovako trebaju izgledati dijelovi sada kada su spojeni.
English: You will hear a “click” when the injection begins.
Croatian: Čut ćete 'klik' kad injekcija započne.
English: You do not see it before, during, or after using the pen.
Croatian: Nećete je vidjeti ni prije, ni tijekom, ni nakon uporabe brizgalice.
English: (This question relates to the steps shown in sections 3a to 3d).
Croatian: (Ovo se pitanje odnosi na korake prikazane u dijelovima 3a do 3d).
English: STOP when you hear the click and the green label disappears.
Croatian: STANITE kad začujete klik, a zelena naljepnica nestane.
English: Before your next injection in 1 week, carefully review the instructions for steps 3a to 4h.
Croatian: Prije sljedeće injekcije za tjedan dana pažljivo proučite upute za korake od 3a do 4h.
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).
Croatian: • Zatvarač ćete možda morati okrenuti nekoliko puta prije nego se oslobodi (ako čujete klikove, okrećete ga u krivom smjeru).
English: C. Check the suspension.
Croatian: Pregledajte suspenziju.
English: If you need to give yourself both at the same time, use two separate injections.
Croatian: Ako morate primijeniti oba u isto vrijeme, koristite dvije zasebne injekcije.
English: This medicine may reduce your appetite, the amount of food you eat, and your weight.
Croatian: Ovaj lijek može smanjiti apetit, količinu hrane koju jedete i Vašu tjelesnu težinu.
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.
Croatian: Nemojte primjenjivati ovaj lijek u djece i adolescenata mlađih od 18 godina jer nema iskustva s primjenom ovog lijeka u ovoj dobnoj skupini.
English: Pay attention to the bottom surface.
Croatian: Obratite pozornost na dno.
English: Do not worry that the vial might come off.
Croatian: Ne brinite da bi bočica mogla otpasti.
English: When it is time for your next weekly dose, start again at step 1.
Croatian: Kada je vrijeme za sljedeću tjednu dozu, ponovno krenite od koraka 1.
English: Before You Begin
Croatian: Prije nego što počnete
English: You should not need to stop your treatment.
Croatian: Neće biti potrebno prekidati liječenje.
English: You will feel the needle go into your skin.
Croatian: Osjetit ćete kako igla ulazi u kožu.
English: For more information, please see Figure N in Step 3B in the Instructions for the User.
Croatian: Za više informacija pogledajte sliku N u koraku 3B u Uputama za korisnika.
English: This guide is divided into sections:
Croatian: Ovaj vodič je podijeljen u poglavlja:
English: When you remove the cover, you may see 1 or 2 drops of liquid.
Croatian: Kad skinete poklopac s igle, možda ćete vidjeti 1 ili 2 kapljice tekućine.
English: The safety and efficacy of prolonged-release exenatide in children and adolescents aged under 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost eksenatida s produljenim oslobađanjem u djece i adolescenata mlađih od 18 godina još nisu ustanovljene.
English: (This question relates to step 4a.)
Croatian: (Ovo se pitanje odnosi na korak 4a.)
English: The clinical relevance of these findings is currently unknown.
Croatian: Klinički značaj tih nalaza za ljude trenutno nije poznat.
English: Read and follow each step in these instructions carefully every time you take Bydureon.
Croatian: Pažljivo pročitajte i slijedite svaki korak u ovim uputama svaki puta kada primjenjujete Bydureon.
English: Put it down for later.
Croatian: Odložite je za kasnije.
English: A. Inject and hold:
Croatian: Injicirajte i zadržite:
English: You should inject this medicine once a week, at any time of day, with or without meals.
Croatian: Ovaj lijek trebate injicirati jednom na tjedan, u bilo koje doba dana, uz obrok ili bez njega.
English: Date of first authorisation: 17 June 2011 Date of latest renewal: 18 February 2016
Croatian: Datum posljednje obnove: 18. veljače 2016.
English: See question number:
Croatian: Vidjeti pitanje broj:
English: All randomised patients who received at least one dose of study medication.
Croatian: Svi randomizirani bolesnici koji su primili najmanje jednu dozu ispitivanog lijeka.
English: The needle is now prepared.
Croatian: Igla je sada pripremljena.