natgillin/translations-raw huggingface dataset:
Potent inhibitors of P-gp, BCRP, OATP1B1 and/or OATP1B3 have the potential to increase the exposure to paritaprevir.
Močni zaviralci P-gp, BCRP, OATP1B1 in/ali OATP1B3 lahko povečajo izpostavljenost paritaprevirju.
Coadministration with ethinyloestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Sočasna uporaba z etinilestradiolom lahko poveča tveganje za zvišanje ALT (glejte poglavji 4.3 in 4.4).
Viekirax with or without dasabuvir was also evaluated without ribavirin in 18 GT1a- and GT4-infected patients; no adverse events of anaemia were seen in these subjects.
Zdravilo Viekirax z ali brez dasabuvirja je bil ovrednoten tudi brez ribavirina pri 18 bolnikih, okuženih z GT1a in GT4; pri teh preiskovancih niso opazili nobenih neželenih učinkov anemije.
All treatment-emergent variants in NS5A remained detectable at post-treatment Week 48.
Vse med zdravljenjem nastale variante gena NS5A so ostale zaznavne 48. teden po zdravljenju.
Viekirax with or without dasabuvir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim..
Zdravilo Viekirax z dasabuvirjem ali brez njega so uporabljali v večkratnih odmerkih v vseh študijah medsebojnega delovanja zdravil, razen v študijah medsebojnega delovanja s karbamazepinom, gemfibrozilom, ketokonazolom in kombinacijo sulfametoksazol/trimetoprim.
Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Pri bolnikih, ki so sočasno okuženi s HIV, je treba skrbno upoštevati medsebojna delovanja zdravil (za podrobnosti glejte poglavje 4.5, preglednico 2):
It is not known whether the active substances in Viekirax (ombitasvir, paritaprevir and ritonavir) pass into breast milk.
Ni znano, ali učinkovine v zdravilu Viekirax (ombitasvir, paritaprevir in ritonavir) prehajajo v materino mleko.
− Tablet film-coating: poly(vinyl alcohol) (E 1203), macrogol (3350), talc (E 553b), titanium dioxide (E 171) and red iron oxide (E 172).
− Filmska obloga tablete: polivinilalkohol (E 1203), makrogol 3350, smukec (E 553b), titanov dioksid (E 171), rdeči železov oksid (E 172).
The combination of atazanavir and Viekirax + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen (see sections 4.4 and 4.8).
Kombinacija atazanavirja in zdravila Viekirax + dasabuvirja zviša ravni bilirubina, zlasti kadar je ribavirin del sheme zdravljenja okužbe z virusom hepatitisa C (glejte poglavji 4.4 in 4.8).
The effect on Cmax and AUC of DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg twice daily was administered with Viekirax with or without dasabuvir.
Vpliv na Cmax in AUC DAA in lopinavirja je bil podoben, kot ko sta bila lopinavir/ritonavir 400 mg/100 mg dvakrat na dan uporabljena skupaj z zdravilom Viekirax, z dasabuvirjem ali brez njega.
No dose adjustment of gemfibrozil is necessary.
Prilagoditev odmerka gemfibrozila ni potrebna.
Although ALT elevations associated with Viekirax and dasabuvir have been asymptomatic, patients should be instructed to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice and discoloured faeces, and to consult a doctor without delay if such symptoms occur.
Čeprav so bila z zdravilom Viekirax in dasabuvirjem povezana zvišanja ALT asimptomatska, je treba bolnikom naročiti, da morajo biti pozorni na zgodnje opozorilne znake vnetja jeter, npr. na utrujenost, šibkost, pomanjkanje apetita, navzeo in bruhanje, pa tudi na poznejše znake, npr. zlatenico, spremembo barve blata, in da se morajo v primeru pojava simptomov brez odlašanja posvetovati z zdravnikom.
Hydrocodone (as given in a fixed-dose hydrocodone/ paracetamol)
Hidrokodon (kot fiksni odmerek kombinacije hidrokodon/par acetamol)
• efavirenz, nevirapine, etravirine
• efavirenz, nevirapin
Unchanged ombitasvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups.
Nespremenjeni ombitasvir je bil glavna snov v mleku doječih podgan, brez vpliva na dojene mladiče.
In the greater than 500 genotype 1a baseline samples in this analysis, the most frequently observed resistance-associated variants were M28V (7.4%) in NS5A and S556G (2.9%) in NS5B.
V več kot 500 izhodiščnih vzorcih genotipa 1a v tej analizi sta bili najpogosteje opaženi z odpornostjo povezani varianti M28V (7,4 %) v NS5A in S556G (2,9 %) v NS5B.
HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
PROTIVIRUSNA ZDRAVILA PROTI HIV: NENUKLEOZIDNI ZAVIRALCI REVERZNE TRANSKRIPTAZE rilpivirin2
↔ dasabuvir sirolimus is used together with Viekirax + dasabuvir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Če je sirolimus uporabljen skupaj z zdravilom Viekirax in dasabuvirjem, dajte sirolimus 0,2 mg dvakrat na teden (vsake 3 ali 4 dni na enaka dva dni vsak teden).
Atazanavir can be used in combination with Viekirax and dasabuvir, if administered at the same time.
Atazanavir se lahko uporablja v kombinaciji z zdravilom Viekirax in dasabuvirjem, če se dajejo ob istem času.
How long to take Viekirax for
Kako dolgo jemati zdravilo Viekirax
Concomitant use of Viekirax and glucocorticoids, particularly long-term use, should only be initiated if the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.5).
Sočasno uporabo zdravila Viekirax in glukokortikoidov, zlasti v primeru dolgoročne uporabe, se sme začeti le, če možna korist zdravljenja odtehta tveganja za sistemske učinke kortikosteroidov (glejte poglavje 4.5).
Table 20.
Preglednica 20.
Accumulation is minimal for ombitasvir and approximately 1.5- to 2-fold for ritonavir and paritaprevir.
Kopičenje ombitasvirja in dasabuvirja je minimalno, kopičenje ritonavirja in paritaprevirja pa približno 1,5- do 2-kratno.
Genotype 1a, with compensated cirrhosis
Genotip 1a, s kompenzirano cirozo
Purpose of the medicine alfuzosin for an enlarged prostate amiodarone, disopyramide, dronedarone used to correct irregular heartbeats astemizole, terfenadine for allergy symptoms.
Namen uporabe zdravila alfuzosin pri povečani prostati amiodaron, dizopiramid, dronedaron za uravnavanje nerednega srčnega utripa astemizol, terfenadin pri simptomih alergije.
Substitutions R155C, A156T/V, and D168H/V in HCV NS3 reduced susceptibility to paritaprevir by 40- to 323-fold.
Substitucije R155C, A156T/V in D168H/V v HCV NS3 so zmanjšale občutljivost za paritaprevir za 40- do 323-krat.
The pharmacokinetics of Viekirax in paediatric patients has not been established (see section 4.2).
Farmakokinetika zdravila Viekirax pri pediatričnih bolnikih ni ugotovljena (glejte poglavje 4.2).
Ombitasvir, paritaprevir and ritonavir should be administered with food.
Ombitasvir, paritaprevir in ritonavir je treba jemati s hrano.
Lopinavir/ritonavir 800/200 mg once daily (administered in the evening) was also administered with Viekirax with or without dasabuvir.
Lopinavir/ritonavir 800 mg/200 mg enkrat na dan (uporabljen zvečer) so uporabili tudi z zdravilom Viekirax, z dasabuvirjem ali brez njega.
Darunavir combined with Viekirax + dasabuvir is not recommended in patients with extensive PI resistance.
Darunavir v kombinaciji z zdravilom Viekirax in dasabuvirjem ni priporočljiv pri bolnikih z obsežno odpornostjo proti PI.
SVR12 for HCV Genotype 4-Infected Subjects with Compensated Cirrhosis Ombitasvir + Paritaprevir + Ritonavir with RBV 12 Weeks
SVR12 pri preiskovancih, okuženih z HCV genotipom 4, s kompenzirano cirozo Ombitasvir + Paritaprevir + Ritonavir z RBV 12 tednov
Ritonavir does not inhibit OAT1 and is not expected to inhibit OCT2, OAT3, MATE1 and MATE2K at clinically relevant concentrations.
Ritonavir ne zavira OAT1 in ni pričakovati, da bi v klinično pomembni koncentraciji zaviral OCT2, OAT3, MATE1 in MATE2K.
Clinical trial in patients receiving opioid substitution therapy
Klinična preskušanja pri prejemnikih opioidnega nadomestnega zdravljenja
Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Opomba: Naslednje variante so bile selekcionirane v celični kulturi, vendar niso nastale med zdravljenjem: varianta gena NS3 A156T v genotipu 1a ter R155Q v genotipu 1b in D168H; varianta gena NS5A Y93C/H v genotipu 1a in L31F/V ali Y93H v kombinaciji z L28M, L31F/V ali P58S v genotipu 1b; in varianta gena NS5B Y448H v genotipu 1a in M414T in Y448H v genotipu 1b.
If a patient is already taking medicinal product(s) or initiating a medicinal product while receiving Viekirax with or without dasabuvir for which potential for drug interaction is expected, dose adjustment of the concomitant medicinal product(s) or appropriate clinical monitoring should be considered (Table 2).
Če bolnik že jemlje zdravilo/zdravila ali med zdravljenjem z zdravilom Viekirax (z dasabuvirjem ali brez njega) začne jemati kakšno zdravilo, za katero obstaja možnost medsebojnega delovanja, je treba razmisliti o prilagoditvi odmerka sočasno uporabljanega zdravila/zdravil ali ustreznem kliničnem spremljanju (preglednica 2).
Available pharmacokinetic data in animals have shown excretion of active substance and metabolite in milk (see section 5.3).
Farmakokinetični podatki, ki so na voljo za živali, so pokazali izločanje učinkovine in presnovka v mleko (glejte poglavje 5.3).
Mechanism: Effect on ciclosporin is due to
Mehanizem: Vpliv na ciklosporin je posledica zavrtja
The changes in ombitasvir, paritaprevir, and ritonavir exposures in subjects with mild, moderate and severe renal impairment are not considered to be clinically significant.
Okvara ledvic Spremembe izpostavljenosti ombitasvirju, paritaprevirju in ritonavirju pri osebah z blago, zmerno in hudo okvaro ledvic ne veljajo za klinično pomembne.
In HCV-infected subjects, in comparison to those without cirrhosis, paritaprevir AUC increased to 2.2- to 2.4-fold for those with compensated cirrhosis (Child-Pugh A) and 3- to 4-fold for those with Child-Pugh B cirrhosis.
Pri preiskovancih, okuženih z virusom hepatitisa C, se je v primerjavi s preiskovanci brez ciroze AUC paritaprevirja povečal 2,2- do 2,4-krat pri tistih s kompenzirano cirozo (Child-Pugh A) in 3- do 4-krat pri tistih z Child-Pugh B cirozo.
Norethindrone (progestin only pill) 0.35 mg once daily
↓ dasabuvir noretindron (tablete, ki vsebujejo samo progestin) 0,35 mg enkrat na dan
GLUCOCORTICOIDS (INHALED) Fluticasone
GLUKOKORTIKOIDI (ZA INHALIRANJE) flutikazon
The activity of ombitasvir was reduced by 661-, 77-, 284- and 142-fold against the genotype 1b substitutions L28T, Y93H, R30Q in combination with Y93H, and L31M in combination with Y93H, respectively.
Aktivnost ombitasvirja se je zmanjšala za 661-, 77-, 284- oziroma 142-krat proti substitucijam genotipa 1b L28T, Y93H, R30Q v kombinaciji z Y93H oziroma L31M v kombinaciji z Y93H.
• oral midazolam, triazolam
• peroralni midazolam, triazolam
Simvastatin, lovastatin and atorvastatin are contraindicated (see sections 4.3 and 4.5).
Simvastatin, lovastatin in atorvastatin so kontraindicirani (glejte poglavji 4.3 in 4.5).
Recommended co-administered medicinal product(s) and treatment duration for Viekirax by patient population
Preglednica 1: Priporočena sočasna zdravila in trajanje zdravljenja z zdravilom Viekirax glede na populacijo bolnikov
Table 17 shows the primary efficacy analysis of SVR12 performed on subjects with HCV GT1/HIV-1 coinfection that received recommended regimen in Part 2 of the TURQUOISE-I study.
Preglednica 17 prikazuje analizo primarne učinkovitosti SVR12 pri preiskovancih, sočasno okuženih s HCV GT1/HIV-1, ki so prejemali priporočen režim zdravljenja v delu 2 študije TURQUOISE-I.
Examples of other CYP3A4 substrates which may require dose adjustment and/or clinical monitoring include calcium channel blockers (e.g. nifedipine), and trazodone.
Med primeri drugih substratov CYP3A4, pri katerih je lahko potrebna prilagoditev odmerka, klinično spremljanje ali oboje, so zaviralci kalcijevih kanalčkov (npr. nifedipin) in trazodon.
Coadministration with enzyme inducers may increase the risk of adverse reactions and ALT elevations (see Table 2).
Sočasna uporaba z induktorji encimov lahko poveča tveganje za neželene učinke in zvišanje ALT (glejte preglednico 2).
Titanium dioxide (E 171) Iron oxide red (E 172)
rdeči železov oksid (E 172)
In subjects receiving Viekirax and dasabuvir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea.
Pri preiskovancih, ki so prejemali zdravili Viekirax in dasabuvir z ribavirinom, sta bila najpogosteje opisana neželena učinka (pri več kot 20 % preiskovancev) utrujenost in navzea.
Viekirax in combination with ribavirin is recommended in genotype 4 infection.
Uporaba zdravila Viekirax z ribavirinom je priporočljiva pri okužbah genotipa 4.
b. Includes subjects who discontinued due to adverse event, loss to follow-up or subject withdrawal, and subjects with reinfection
b. Vključuje preiskovance, ki so prenehali z zdravljenjem zaradi neželenih učinkov, ki so jih prenehali spremljati v zvezi z neželenimi učinki ali pa so sami odstopili in preiskovance, ki so se ponovno okužili.
See Table 2 for guidance regarding potential interactions with other medicinal products and dosing recommendations.
Za vodila glede možnih medsebojnih delovanj z drugimi zdravili in priporočila za odmerjanje glejte preglednico 2.
Concomitant use of inhaled glucocorticoids metabolised with CYP3A can increase systemic exposures of the glucocorticoids, and cases of Cushing's syndrome and subsequent adrenal suppression have been reported with ritonavir-containing regimens.
Sočasna uporaba inhaliranih glukokortikoidov, ki se presnavljajo s CYP3A, lahko poveča sistemsko izpostavljenost glukokortikoidom; med uporabo shem zdravljenja z ritonavirjem so bili opisani primeri Cushingovega sindroma in posledične supresije nadledvičnih žlez.
Table 19.
Preglednica 19.
As liver function may change during treatment with Viekirax administered with or without dasabuvir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Ker se delovanje jeter med zdravljenjem z zdravilom Viekirax ob jemanju z ali brez dasabuvirja lahko spremeni, je priporočljivo skrbno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR
Ritonavir is a strong inhibitor of CYP3A.
Ritonavir močno zavira CYP3A.
What you need to know before you take Viekirax Do not take Viekirax
Kaj morate vedeti, preden boste vzeli zdravilo Viekirax Ne jemljite zdravila Viekirax:
The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 Kcal versus approximately 1000 Kcal).
Povečanje izpostavljenosti je bilo podobno ne glede na vrsto obroka (npr. zelo masten obrok v primerjavi z zmerno mastnim) ali kalorično vrednost (približno
Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2D6/CYP1A2 substrate, duloxetine.
Zdravilo Viekirax, uporabljeno z dasabuvirjem ali brez njega, ni vplivalo na izpostavljenost substratu CYP2D6/CYP1A2, duloksetinu.
NA Patients should be monitored for clinical effects; a decrease in furosemide dose of up to 50% may be required.
potrebno je lahko do 50 % zmanjšanje odmerka furosemida.
In the presence of paritaprevir/ritonavir, dasabuvir exposures decreased by approximately 50% to 60% while ombitasvir exposures increased by 31-47%.
Vpliv paritaprevirja/ritonavirja na ombitasvir in dasabuvir V prisotnosti paritaprevirja/ritonavirja se je izpostavljenost dasabuvirju zmanjšala za približno 50 do 60 %, izpostavljenost ombitasvirju pa se je povečala za 31 do 47 %.
In the greater than 200 genotype 1b baseline samples in this analysis, the most frequently observed resistance-associated variants observed were Y93H (7.5%) in NS5A, and C316N (17.0%) and S556G (15%) in NS5B.
V več kot 200 izhodiščnih vzorcih genotipa 1b v tej analizi sta bili najpogosteje opaženi z odpornostjo povezani varianti Y93H (7,5 %) v NS5A in C316N (17,0 %) v NS5B.
Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper limit of normal according to testing laboratory.
(3. stopnja) > 10 × ZNM (4. stopnja) *ZNM: zgornja normalna meja v laboratoriju, ki je opravil testiranje.
Lurasidone Pimozide Quetiapine
ANTIPSIHOTIKI lurasidon pimozid kvetiapin
Severe renal impairment or ESRD includes CKD Stage 4 defined as eGFR <30-15 mL/min/1.73 m2 or CKD Stage 5 defined as <15 mL/min/1.73 m2 or requiring haemodialysis.
ml/min/1,73 m2, ali CKD 5. stopnje, definirane kot <15 mL/min/1,73 m2 ali če je potrebna hemodializa.
Ombitasvir is metabolised via amide hydrolysis followed by oxidative metabolism.
Ombitasvir se presnovi z amidno hidrolizo, ki ji sledi oksidativna presnova.
No clinically relevant changes in dasabuvir, paritaprevir and ombitasvir exposures (based on comparison with historical data) were observed during co-administration.
Med sočasno uporabo niso opazili klinično pomembnih sprememb izpostavljenosti dasabuvirju, paritaprevirju in ombitasvirju (na podlagi primerjave historičnih podatkov).
− Tablet core: copovidone, tocofersolan, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E 551), sodium stearyl fumarate.
− Jedro tablete: kopovidon, tokofersolan, propilenglikol monolavrat, sorbitan monolavrat, koloidni brezvodni silicijev dioksid (E 551), natrijev stearilfumarat.
NA Clinical monitoring of patients is recommended.
NA Bolnike je priporočljivo klinično
5 days after completion of Viekirax + dasabuvir treatment, the sirolimus dose and dosing frequency prior to receiving Viekirax should be resumed, along with routine monitoring of sirolimus blood concentrations.
5 dni po zaključenem zdravljenju z zdravilom Viekirax in dasabuvirjem je potrebno ponovno vzpostaviti odmerek in pogostnost odmerjanja sirolimusa kot pred začetkom jemanja zdravila Viekirax in dasabuvirja, skupaj z rutinskim spremljanjem koncentracij sirolimusa v krvi.
In vitro data indicate that paritaprevir is a substrate for the human hepatic uptake transporters, OATP1B1 and OATP1B3.
Podatki in vitro kažejo, da je paritaprevir substrat humanih jetrnih privzemnih prenašalcev OATP1B1 in OATP1B3.
Resistance to paritaprevir and ombitasvir conferred by variants in NS3 and NS5A respectively, selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons.
Genotip 1 Odpornost proti paritaprevirju in ombitasvirju, povezana z variantami NS3 in NS5A, selekcioniranih v celičnih kulturah ali identificiranih v kliničnih preskušanjih faze 2b in 3, so fenotipsko opredelili v ustreznih replikonih genotipa 1a ali 1b.
Contents of the pack and other information
Shranjevanje zdravila Viekirax Vsebina pakiranja in dodatne informacije
Administration of Viekirax with or without dasabuvir with erythromycin may result in increased concentrations of erythromycin and paritaprevir.
Sočasna uporaba zdravila Viekirax z ali brez dasabuvirja in eritromicina lahko povzroči povečanje koncentracij eritromicina in paritaprevirja.
300/100 mg once daily (administered 12 hours apart)
300/100 mg enkrat na dan (uporabljena v razmaku 12 ur)
When taking Viekirax with dasabuvir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems:
Če zdravilo Viekirax jemljete z dasabuvirjem, obvestite svojega zdravnika, če imate naslednje simptome,
Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Sočasna uporaba s fluvastatinom in pitavastatinom ni priporočljiva (glejte poglavje 4.4).
During clinical trials with Viekirax and dasabuvir with or without ribavirin, transient elevations of ALT to greater than 5 times the upper limit of normal occurred in approximately 1% of subjects (35 of 3,039).
Med kliničnimi preskušanji z zdravilom Viekirax in dasabuvirjem skupaj z ribavirinom ali brez njega se je prehodno zvišanje ALT v serumu na več kot 5-kratno zgornjo normalno mejo pojavilo pri približno 1 % preiskovancev (35 od 3.039).
Beginning the day after Viekirax and dasabuvir are initiated; reinitiate tacrolimus at a reduced dose based on tacrolimus blood concentrations.
En dan po začetku uporabe zdravila Viekirax in dasabuvirja se lahko ponovno uvede takrolimus v zmanjšanem odmerku, ki temelji na koncentracijah takrolimusa v krvi.
Viekirax without ribavirin and without dasabuvir was also evaluated in genotype 1b infected subjects in Phase 2 studies M13-393 (PEARL-I) and M12-536.
Pri preiskovancih, okuženih z genotipom 1b, so raziskali tudi zdravilo Viekirax brez ribavirina in brez dasabuvirja, in sicer v študijah 2. faze M13-393 (PEARL-I) in M12-536.
Viekirax contains the active substances ombitasvir, paritaprevir and ritonavir.
Zdravilo Viekirax vsebuje učinkovine ombitasvir, paritaprevir in ritonavir.
Viekirax and dasabuvir with or without ribavirin were assessed in 68 subjects with genotype 1 infection with or without cirrhosis who have severe renal impairment or ESRD (see Section 5.1).
Zdravilo Viekirax in dasabuvir z ali brez ribavirina je bilo ovrednoteno pri 68 preiskovancih z okužbo genotipa 1 z ali brez ciroze, ki so imeli hudo okvaro ledvic ali končno ledvično odpoved (glejte poglavje 5.1).
Ombitasvir, paritaprevir and ritonavir were absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Ombitasvir, paritaprevir in ritonavir so se po peroralni uporabi absorbirali s povprečnim tmax približno 4 do 5 ur.
Viekirax and dasabuvir 12 weeks N = 509 n (%)
Viekirax in dasabuvir 12 tednov N = 509 n (%)
14 film-coated tablets Component of a multipack, can't be sold separately.
Komponenta večkratnega pakiranja, ni za ločeno prodajo.
Nearly the entire plasma radioactivity after a single 600 mg dose of 14C-ritonavir oral solution in humans was attributed to unchanged ritonavir.
Skoraj vsa radioaktivnost v plazmi, po enkratnem 600 mg odmerku peroralne raztopine 14C-ritonavirja pri človeku, je izvirala od nespremenjenega ritonavirja.
Viekirax tablets are taken with other antiviral medicines such as dasabuvir and ribavirin.
Tablete zdravila Viekirax se jemljejo skupaj z drugimi protivirusnimi zdravili, kot sta dasabuvir in ribavirin.
The recommended oral dose of Viekirax is two 12.5 mg / 75 mg / 50 mg tablets once daily with food.
Priporočeni peroralni odmerek zdravila Viekirax sta dve tableti 12,5 mg/75 mg/50 mg 1-krat na dan s hrano.
You should not breast-feed during treatment with Viekirax.
Med zdravljenjem z zdravilom Viekirax ne smete dojiti.
TURQUOISE-II: Relapse Rates by Baseline Laboratory Values after 12 and 24 Weeks of Treatment in Subjects with Genotype 1a Infection and Compensated Cirrhosis
Preglednica 14: TURQUOISE-II: Deleži recidivov glede na izhodiščne laboratorijske vrednosti, po 12 in 24 tednih zdravljenja, pri preiskovancih s kompenzirano cirozo, okuženih z genotipom 1a
Overall, 107 of 113 subjects without cirrhosis and 147 of 155 subjects with cirrhosis achieved SVR12 after 12-24 weeks of treatment.
V celoti je po 12 do 24 tednih zdravljenja SVR12 doseglo 107 od 113 bolnikov brez ciroze in 147 od 155 bolnikov s cirozo.
Tell your doctor or pharmacist if you notice any of the following side effects.
Obvestite zdravnika ali farmacevta, če opazite kateri koli neželeni učinek, naveden v nadaljevanju.
Compared to the subjects with normal renal function, ombitasvir exposures were comparable in subjects with mild, moderate and severe renal impairment.
V primerjavi s preiskovanci z normalnim delovanjem ledvic je bila izpostavljenost ombitasvirju primerljiva kot pri preiskovancih z blago, zmerno in hudo okvaro ledvic.
Expected: ↑ amiodarone
Pričakovano: ↑ amiodaron