natgillin/translations-raw huggingface dataset:
Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 19.8% had a body mass index of at least 30 kg/m2; 20.6% had a history of depression or bipolar disorder; 89.6% had IL28B non-CC genotype; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection. 
Zdravljeni preiskovanci (N = 394) so bili mediano stari 54 let (razpon: od 19 do 71); 49,0 % jih predhodno ni imelo odziva na pegIFN/RBV; 21,8 % jih je predhodno imelo delen odziv na pegIFN/RBV in 29,2 % jih je predhodno imelo recidiv ob pegIFN/RBV; 57,6 % je bilo moških; 8,1 % je bilo črncev; 19,8 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 20,6 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 89,6 % jih je imelo genotip IL28B ne-CC; 87,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 17,8 % jih je imelo portalno fibrozo (F2) in 14,5 % jih je imelo fibrozo z mostiči (F3); 58,4 % jih je imelo okužbo s HCV genotipa 1a; 41,4 % jih je imelo okužbo s HCV genotipa 1b.
Exviera safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin. 
Sočasna uporaba z drugimi neposredno delujočimi protivirusnimi zdravili proti HCV Varnost in učinkovitost zdravila Exviera sta bili ugotovljeni v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem, z ribavirinom ali brez njega.
Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks) 
Skupina A: Exviera in ombitasvir/paritaprevir/ritonavir + RBV (12 tednov)
metabolite were not meaningfully different in subjects with hepatic impairment compared to normal control subjects (see sections 4.2, 4.4 and 4.8). 
Vezava dasabuvirja in njegovega presnovka M1 na beljakovine v plazmi se pri preiskovancih z okvaro jeter nista bistveno razlikovali od tistih pri zdravih kontrolnih osebah (glejte poglavja 4.2, 4.4 in 5.2).
Subjects were randomised in a 1:1 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment. 
Preiskovanci so bili randomizirani v razmerju 1:1 za 12-tedensko zdravljenje z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
What Exviera contains 
Kaj vsebuje zdravilo Exviera
Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; 21.8% had a body mass index of at least 30 kg/m2; 12.8% had a history of depression or bipolar disorder; 90.5% had IL28B non-CC genotype; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3). 
Zdravljeni preiskovanci (N = 179) so bili mediano stari 57 let (razpon: od 26 do 70); 35,2 % jih predhodno ni imelo odziva na pegIFN/RBV; 28,5 % jih je predhodno imelo delen odziv na pegIFN/RBV in 36,3 % jih je predhodno imelo recidiv ob pegIFN/RBV; 54,2 % je bilo moških; 3,9 % je bilo črncev; 21,8 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 12,8 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 90,5 % jih je imelo genotip IL28B ne-CC; 87,7 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 17,9 % jih je imelo portalno fibrozo (F2) in 14,0 % jih je imelo fibrozo z mostiči (F3).
Table 10 shows the SVR12 rates for treatment-experienced subjects with genotype 1-infection receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-II. 
Preglednica 10 prikazuje deleže SVR12 pri že zdravljenih preiskovancih, okuženih z genotipom 1, ki so v preskušanju SAPPHIRE-II 12 tednov dobivali zdravilo Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
Atazanavir/ ritonavir 300/100 mg once daily 
atazanavir 300 mg enkrat na dan (dan ob istem času)
Subjects were randomised in a 1:2 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment. 
Preiskovanci so bili randomizirani v razmerju 1:2 za 12-tedensko zdravljenje z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
TURQUOISE-II was a randomised, global multicentre, open-label trial conducted exclusively in 380 genotype 1-infected subjects with compensated cirrhosis (Child-Pugh A) who were either treatmentnaïve or did not achieve SVR with prior treatment with pegIFN/RBV. 
Preskušanje TURQUOISE-II je bilo globalno multicentrično, randomizirano, odprto preskušanje izključno pri 380 preiskovancih, okuženih z genotipom 1, ki so imeli kompenzirano cirozo (Child
PEARL-III was a randomised, global multicentre, double-blind, controlled trial conducted in 419 treatment-naïve adults with genotype 1b chronic hepatitis C virus infection without cirrhosis. 
Preskušanje PEARL-III je bilo globalno multicentrično, randomizirano, dvojno slepo, kontrolirano preskušanje pri 419 še nezdravljenih odraslih, ki so imeli kronično okužbo z virusom hepatitisa C
Arm B: Exviera and ombitasvir/paritaprevir/ritonavir 
Skupina B: Exviera in ombitasvir/paritaprevir/ritonavir
Patients should be informed that fatigue has been reported during treatment with Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin (see section 4.8). 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Bolnikom je treba povedati, da je bila med zdravljenjem z zdravilom Exviera v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem in ribavirinom opisana utrujenost (glejte poglavje 4.8).
In all seven trials, the Exviera dose was 250 mg twice daily and the ombitasvir/paritaprevir/ritonavir dose was 25 mg/150 mg/100 mg once daily. 
V vseh sedmih preskušanjih je bil odmerek zdravila Exviera 250 mg dvakrat na dan in odmerek kombinacije ombitasvir/paritaprevir/ritonavir 25/150/100 mg enkrat na dan. Preiskovanci, ki so dobivali ribavirin, so dobivali odmerek 1000 mg ribavirina na dan, če so tehtali manj kot 75 kg,
Plasma protein binding of dasabuvir and its M1 
Upoštevaje vezavo na beljakovine in aktivnost M1 proti
No dose adjustment is necessary for emtricitabine/tenofovir and Exviera + ombitasvir/paritaprevir/ ritonavir. 
Prilagoditev odmerka ni potrebna za emtricitabin/tenof ovir in kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
Exviera and ombitasvir/paritaprevir /ritonavir + ribavirin 
Exviera in ombitasvir/paritaprevir /ritonavir + ribavirin
Interactions between Exviera with ombitasvir/paritaprevir/ritonavir and other medicinal products 
Medsebojna delovanja z drugimi zdravili med uporabo zdravila Exviera s kombinacijo ombitasvir/paritaprevir/ritonavir
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Exviera is used with ribavirin. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Če je zdravilo Exviera uporabljeno z ribavirinom, je potrebna skrajna previdnost, da bi preprečili nosečnost bolnic in partnerk bolnikov.
Treatment duration was fixed in each trial and was not guided by subjects' 
Trajanje zdravljenja je bilo v vsakem preskušanju fiksno in ga niso prilagajali koncentraciji HCV RNA pri preiskovancih (algoritem brez upoštevanja odziva).
CYP3A4 inhibition by ritonavir. 
Indukcija CYP3A4 s fenobarbitalom.
The pharmacokinetic properties of the combination of Exviera with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 17 shows mean Cmax and AUC of Exviera 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers. 
C. Preglednica 16 prikazuje povprečni Cmax in AUC za zdravilo Exviera 250 mg dvakrat na dan s kombinacijo ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg enkrat na dan po večkratnih odmerkih s hrano pri zdravih prostovoljcih.
PEARL-IV was a randomised, global multicentre, double-blind, controlled trial conducted in 305 treatment-naïve adults with genotype 1a chronic hepatitis C virus infection without cirrhosis. 
Preskušanje PEARL-IV je bilo globalno, multicentrično, randomizirano, dvojno slepo, kontrolirano preskušanje pri 305 še nezdravljenih odraslih, ki so imeli kronično okužbo z virusom hepatitisa C
Table 7 shows the SVR12 rates for genotype 1-infected, treatment-naïve subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-I. 
Preglednica 7 prikazuje deleže SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1, ki so v preskušanju SAPPHIRE-I 12 tednov dobivali zdravilo Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
Table 11 shows the SVR12 rates for genotype 1b-infected, treatment-experienced subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL II. 
Preglednica 11 prikazuje deleže SVR12 pri že zdravljenih preiskovancih, okuženih z genotipom 1b, ki so v preskušanju PEARL II 12 tednov dobivali zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 28.4% had a body mass index of at least 30 kg/m2; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 81.8% had IL28B non-CC genotype; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection. 
Zdravljeni preiskovanci (N = 380) so bili mediano stari 58 let (razpon: od 21 do 71); 42,1 % jih še ni bilo zdravljenih, 36,1 % jih predhodno ni imelo odziva na pegIFN/RBV; 8,2 % jih je predhodno imelo delen odziv na pegIFN/RBV in 13,7 % jih je predhodno imelo recidiv ob pegIFN/RBV; 70,3 % je bilo moških; 3,2 % je bilo črncev; 28,4 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 14,7 % jih je imelo število trombocitov manj kot 90 x 109/l; 49,7 % jih je imelo albumin manj kot 40 g/l; 86,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 81,8 % jih je imelo genotip IL28B
No increase in incidence of ALT elevations was observed with other types of systemic estrogens commonly used for hormone replacement therapy (e.g., estradiol and conjugated estrogens). 
Z drugimi vrstami sistemskih estrogenov, ki se pogosto uporabljajo za hormonsko nadomestno zdravljenje (npr. z estradiolom in konjugiranimi estrogeni), niso opažali večje incidence zvišanj ALT. Zvišanja ALT so bila praviloma asimptomatska, so se po navadi pojavila v prvih 4
Table 8 shows the SVR12 rates for genotype 1b-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL III. 
Preglednica 8 prikazuje deleže SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1b, ki so v preskušanju PEARL III 12 tednov dobivali zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
NA Clinical monitoring of 
Kumulativne analize kliničnih preskušanj
Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 16.5% had a body mass index of at least 30 kg/m2; 9.3% had a history of depression or bipolar disorder; 79.0% had IL28B non-CC genotype; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3). 
Zdravljeni preiskovanci (N = 419) so bili mediano stari 50 let (razpon: od 19 do 70); 45,8 % je bilo moških; 4,8 % je bilo črncev; 16,5 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 9,3 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 79,0 % jih je imelo genotip IL28B ne-CC; 73,3 %
As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicine, such medicinal products are contraindicated with Exviera and ombitasvir/paritaprevir/ritonavir. 
Ker je bila incidenca takšnih zvišanj med ženskami, ki so sočasno jemale zdravilo z etinilestradiolom, 26 %,
20-120 mg once daily5 
20-120 mg enkrat na dan
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir. 
OATP1B s paritaprevirjem in zavrtje BCRP z dasabuvirjem, paritaprevirjem in ritonavirjem.
300 mg single dose 
Po uporabi 400-mg odmerka
↔ es citalopram 
ANTIDEPRESIVI escitalopram
No dose adjustment is necessary for raltegravir or Exviera + ombitasvir/paritaprevir/ ritonavir. 
Prilagoditev odmerka ni potrebna za raltegravir ali kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
Caution should be used when sulfasalazine is co-administered with Exviera + ombitasvir/paritaprevir/ ritonavir. 
Previdnost je potrebna, ko se sulfasalazin daje sočasno z zdravilom Exviera ombitasvir/paritap revir/ritonavir.
↔ nor ethindrone 
buprenorfin/nal okson
carbamaze pine 10, 11epoxide dasabuvir 
Sočasna uporaba je kontraindicirana (glejte poglavje karbamazepin 10, 11-epoksid dasabuvir
Exviera and ombitasvir/paritaprevir/ritonavir with RBV 24-week arm 
Exviera in ombitasvir/paritaprevir/ritonavir z RBV 24-tedenska skupina
MEDICINAL PRODUCTS USED IN MULTIPLE SCLEROSIS Teriflunomid e 
ZDRAVILA, KI SE UPORABLJAJO PRI ZDRAVLJENJU MULTIPLE SKLEROZE teriflunomid Exviera + ombitasvir/p aritaprevir/ri tonavir
AMINOSALICYLATE Sulfasalazine 
AUC Ctrough Klinične opombe sulfasalazin
The overall safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV mono-infected subjects. 
Celotne varnostne značilnosti pri prejemnikih presadka, okuženih s HCV, ki so prejemali zdravilo
Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 19.7% had a body mass index of at least 30 kg/m2; 20.7% had a history of depression or bipolar disorder; 69.2% had IL28B non-CC genotype; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3). 
Zdravljeni preiskovanci (N = 305) so bili mediano stari 54 let (razpon: od 19 do 70); 65,2 % je bilo moških; 11,8 % je bilo črncev; 19,7 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 20,7 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 69,2 % jih je imelo genotip IL28B ne-CC; 86,6 %
Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir. 
Mehanizem: Zavrtje P-gp v črevesju s paritaprevirjem in ritonavirjem.
buprenorphin e/ naloxone 4-24 mg/16 mg once daily 
4-24 mg/1-6 mg enkrat na dan
ombitas vir/parit aprevir/r itonavir 
Exviera + paritaprevir/r itonavir
Exviera and ombitasvir/paritaprevir/ritonavir with RBV 12 weeks 
Exviera in ombitasvir/paritaprevir/ritonavir z RBV 12 tednov
Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV 
Exviera in ombitasvir/paritaprevir/ritonavir 12 tednov Z RBV
Clinical Comments paritaprevir changes during treatment with Exviera ombitasvir/paritaprevir/ ritonavir 
Neželeni učinki pri jemanju zdravila Exviera s kombinacijo ombitasvir/paritaprevir/ritonavir
Exviera and ombitasvir/paritaprevir/ritonavir 
Exviera in ombitasvir/paritaprevir /ritonavir
Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin was given for 12 weeks of treatment. 
Preiskovanci so zdravljenje z zdraviloma Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom dobivali 12 tednov.
Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin were administered for either 12 or 24 weeks of treatment. 
Preiskovanci so zdravljenje z zdravilom Exviera in ombitasvirjem/paritaprevirjem/ritonavirjem v kombinaciji z ribavirinom dobivali 12 ali 24 tednov.
Duration 
Recidiv
THYROID HORMONES Levothyroxin e 
ZDRAVILA Z DELOVANJEM NA BAKTERIJO MYCOBACTERIUM TUBERCULOSIS rifampicin
NA No dose adjustment is necessary for paracetamol when administered with Exviera + ombitasvir/paritaprevir/ ritonavir. 
NP Prilagoditev odmerka paracetamola ni potrebna, kadar se sočasno daje s kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
Efavirenz/ emtricitabine / tenofovir disoproxil fumarate mg once daily 
efavirenz/emtri citabin/tenofovi rijev dizoproksilfum arat
Exviera ombitas vir/parit aprevir/r itonavir 
Exviera + ombitasvir/ paritaprevir/r itonavir
Lansoprazole 
levotiroksin
Exviera and ombitasvir/paritaprevir/ritonavir with RBV 12-week arm 
Exviera in ombitasvir/paritaprevir/ritonavir z RBV 12-tedenska skupina
↑ fluvastatin ↑ pitavastatin ↔ dasabuvir ↔ ombitasvir ↔ paritaprevir 
↔ dasabuvir ↔ ombitasvir ↔ paritaprevir esomeprazol lansoprazol
↑ levothyroxine 
↑ furosemid
When starting coadministration with Exviera and ombitasvir/paritaprevir/ ritonavir, give one fifth of the total daily dose of ciclosporin once daily with ombitasvir/ paritaprevir /ritonavir. 
Na začetku sočasne uporabe z zdravilom Exviera in kombinacijo ombitasvir/paritap revir/ritonavir dajte eno petino
NA No dose adjustment needed for abacavir or lamivudine when administered with Exviera + ombitasvir/paritaprevir/ ritonavir. 
Prilagoditev odmerka abakavirja ali lamivudina ni potrebna, kadar se sočasno daje s kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
Concomitant use is contraindicated (see section 4.3). 
Sočasna uporaba je kontraindicirana (glejte poglavje imatinib
Very common 
Pogosti pruritus
nordiazepam 
norgestrel
ANTIDEPRESSANTS Escitalopram 10 mg single dose 
ANTIARITMIKI digoksin enkraten odmerek 0,5 mg
Table 9 shows the SVR12 rates for genotype 1a-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL IV. Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin was not non-inferior to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin. 
Preglednica 9 prikazuje deleže SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1a, ki so v preskušanju PEARL IV 12 tednov dobivali zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
No dose adjustment of Exviera is required in patients with mild hepatic impairment (Child-Pugh A). 
Bolnikom z blago okvaro jeter (Child-Pugh A) odmerkov zdravila Exviera ni treba prilagoditi.
↓ dasabuvir ↓ paritaprevir ↓ ombitasvir 
↓ dasabuvir ↓ombitasvir ↓ paritaprevir
200 mg once daily followed by 
200 mg enkrat na dan in nato 200 mg dvakrat na dan
NA No dose adjustment needed for sofosbuvir when administered with Exviera + ombitasvir/paritaprevir /ritonavir. 
NP Prilagoditev odmerka sofosbuvirja ni potrebna, kadar se sočasno daje s kombinacijo Exviera + ombitasvir/paritapr evir/ritonavir.
↓ dasabuvir ombitasvir paritaprevir norethindrone (progestin only pill) 0.35 mg once daily 
dasabuvir ombitasvir paritaprevir duloksetin Posamezen odmerek 60 mg
PEARL-II was a randomised, global multicentre, open-label trial conducted in 179 adults with chronic genotype 1b hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV. 
odraslih, ki so imeli kronično okužbo z virusom hepatitisa C genotipa 1b brez ciroze in s predhodnim zdravljenjem s pegIFN/RBV niso dosegli SVR.
Co-administration of Exviera and ombitasvir/paritaprevir/ ritonavir with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QTprolongation coadministered medicinal products. 
↑ paritaprevir enkrat na dan pride v poštev le pri bolnikih brez znanega podaljšanja intervala QT in brez sočasne uporabe kakšnih drugih zdravil, ki podaljšajo interval
ANTIMYCOBACTERIALS 
ŠČITNIČNI HORMONI
In a pooled analysis of clinical trials with Exviera and ombitasvir/paritaprevir/ritonavir with and without ribavirin, 1% of subjects experienced serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment. 
V kumulativni analizi kliničnih preskušanj zdravila Exviera s kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega se je po začetku zdravljenja zvišanje
NA No dose adjustment for cyclobenzaprine required; increase dose if clinically indicated. 
Prilagoditev odmerka ciklobenzaprina ni potrebna;
ombitas vir/parit aprevir/ ritonavi r alprazolam (1.03-1.15) (1.15-1.55) 
Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir (glejte poglavji 4.3 in 4.5).
No dose adjustment needed for Exviera + ombitasvir/paritaprevir/ ritonavir. 
Prilagoditev odmerka ni potrebna za kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
Posology 
Zavrtje
Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 16.2% had a body mass index of at least 30 kg/m2; 15.2% had a history of depression or bipolar disorder; 69.3% had IL28B non-CC genotype; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection. 
Zdravljeni preiskovanci (N = 631) so bili mediano stari 52 let (razpon: od 18 do 70); 54,5 % je bilo moških; 5,4 % je bilo črncev; 16,2 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 15,2 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 69,3 % jih je imelo genotip IL28B ne-CC; 79,1 %
The EC50 of dasabuvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 7.7 and 1.8 nM, respectively. 
Aktivnost v celični kulturi in biokemičnih študijah V preizkusih z replikonsko celično kulturo HCV je bila EC50 dasabuvirja proti sevu genotipa 1a-H77
A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment. 
Sočasna uporaba s fluvastatinom in pitavastatinom ni priporočljiva
The recommended dose is one tablet taken once a day. 
Priporočeni odmerek je ena tableta enkrat dnevno.
Other information about Qtern 
Druge informacije o zdravilu Qtern
What measures are being taken to ensure the safe and effective use of Qtern? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Qtern?
This is a summary of the European public assessment report (EPAR) for Qtern. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Qtern.
The full EPAR for Qtern can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Qtern je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Qtern contains two different active substances, which work in different ways: 
Zdravilo Qtern vsebuje dve različni zdravilni učinkovini, ki delujeta na različna načina:
Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012; 
Dapagliflozin je v Evropski uniji (EU) odobren od leta 2012 kot zdravilo Forxiga;
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Qtern's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Qtern večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtern have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Qtern, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
It is not intended to provide practical advice on how to use Qtern. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.