FrancophonIA/ELRC3.0 huggingface dataset:
English: Ivacaftor has been studied with an oestrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the oral contraceptive.
Slovenian: Ivakaftor so proučevali z estrogensko/progesteronskim peroralnim kontraceptivom in ugotovili, da nima pomembnega učinka na izpostavljenost peroralnemu kontraceptivu.
English: No specific antidote is available for overdose with ivacaftor.
Slovenian: Za preveliko odmerjanje ivakaftorja nimamo na voljo specifičnega antidota.
English: The apparent clearance (CL/F) of ivacaftor was similar for healthy subjects and patients with CF.
Slovenian: Navidezni očistek (CL/F) ivakaftorja je bil pri zdravih preiskovancih in bolnikih s CF podoben.
English: Ivacaftor was permanently discontinued in one patient.
Slovenian: Pri enem bolniku so ivakaftor trajno ukinili.
English: Do not give this medicine to children under 6 months of age with gating mutations as it is not known if ivacaftor is safe and effective in these children, or in patients under 18 years of age with an R117H mutation as ivacaftor may not work in them.
Slovenian: Ne dajajte tega zdravila otrokom, mlajšim od 6 mesecev, z mutacijami spreminjanja prehodnosti kanalčkov celične membrane, ker ni znano, ali je ivakaftor pri teh otrocih varen in učinkovit, niti bolnikom z mutacijo R117H, mlajšim od 18 let, ker ivakaftor pri njih mogoče ne bo učinkovit.
English: Absolute change in percent predicted FEV1 (percentage points)
Slovenian: Absolutna sprememba v odstotkih napovedanega FEV1 (odstotne točke)
English: • Tear or cut sachet open along cut line.
Slovenian: • Pretrgajte ali prerežite vrečico po prekinjeni črti.
English: In part 2, all patients received ivacaftor as indicated in part 1 for 16 additional weeks.
Slovenian: V drugem delu so vsi bolniki še 16 dodatnih tednov prejemali ivakaftor v skladu z indikacijo v prvem delu.
English: • A fat-containing meal or snack should be given to your child just before or just after dosing (some examples are provided below).
Slovenian: • Tik pred odmerjanjem ali tik po njem naj otrok dobi masten obrok ali prigrizek (nekaj primerov je navedenih v nadaljevanju).
English: The AUC of ivacaftor when given in combination with tezacaftor increased approximately 3-fold when given with fat containing food.
Slovenian: AUC ivakaftorja, ki so ga dajali v kombinaciji s tezakaftorjem, se je zvečala približno 3-krat, kadar so ga dajali skupaj s hrano, ki je vsebovala maščobe.
English: No dose adjustment is considered necessary unless moderate hepatic impairment exists.
Slovenian: Menijo, da prilagajanje odmerka ni potrebno, če ni prisotna zmerna okvara jeter.
English: Do not break, chew or dissolve the tablets.
Slovenian: Tablet ne prelomite, ne žvečite in ne raztopite.
English: Take Kalydeco tablets with food that contains fat.
Slovenian: Tablete zdravila Kalydeco jemljite s hrano, ki vsebuje maščobe.
English: The mean (SD) Faecal Elastase-1 value at baseline (n = 27) was 28 µg/g (95).
Slovenian: Povprečna (SD) vrednost fekalne elastaze-1 v izhodišču (n = 27) je bila 28 µg/g (95).
English: Less evidence of a positive effect of ivacaftor has been shown for patients with an R117H-7T mutation associated with less severe disease (see section 5.1).
Slovenian: Manj dokazov pozitivnega vpliva ivakaftorja so našli pri bolnikih z mutacijo R117H-7T, povezano z manj težko boleznijo (glejte poglavje 5.1).
English: The pharmacokinetic parameters of ivacaftor, either as monotherapy or in combination with tezacaftor, are similar in males and females.
Slovenian: Farmakokinetični parametri ivakaftorja, bodisi samega ali v kombinaciji s tezakaftorjem, so podobni pri moških in ženskah.
English: Do not give your child a double dose to make up for a forgotten dose.
Slovenian: Ne dajte otroku dvojnega odmerka, če ste mu pozabili dati prejšnji odmerek.
English: Long-term effectiveness study to compare disease progression among children with CF who have a specified CFTR gating mutation and are aged 2 through 5 years at the time of Kalydeco treatment initiation versus disease progression among concurrent matched cohort of children with CF who have never received Kalydeco treatment.
Slovenian: Dolgoročna študija učinkovitosti za primerjavo napredovanja bolezni pri otrocih s CF, ki imajo določeno mutacijo spreminjanja prehodnosti CFTR in bodo v času uvedbe zdravljenja z zdravilom Kalydeco stari 2 do 5 let, z napredovanjem bolezni pri skladni kohorti otrok primerljive starosti s CF, ki se niso nikoli zdravili z zdravilom Kalydeco.
English: There is no experience of the use of Kalydeco in patients with severe hepatic impairment; therefore, its use is not recommended unless the benefits outweigh the risks.
Slovenian: Izkušenj z uporabo zdravila Kalydeco pri bolnikih s težkimi okvarami jeter ni, zato uporabe zdravila Kalydeco pri teh bolnikih ne priporočajo, razen če koristi zdravljenja odtehtajo tveganje.
English: • Cheese, whole milk, whole-milk dairy products, yogurt, chocolate
Slovenian: • sir, neposneto mleko, mlečni izdelki iz neposnetega mleka, jogurt, čokolada
English: A single ivacaftor-treated patient (2.5%) in this age range had an elevation of ALT and AST > 8 x ULN.
Slovenian: En sam bolnik v tej starostni skupini (2,5 %), zdravljen z ivakaftorjem, je imel zvišanje ALT in AST > 8 x ULN.
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in adolescent patients (12 to 17 year-olds) are comparable to those in adults (see Table 8).
Slovenian: Farmakokinetični parametri ivakaftorja v kombinaciji s tezakaftorjem pri mladostnikih (starih 12 do 17 let) so primerljivi s tistimi pri odraslih (glejte preglednico 8).
English: If you have been prescribed Kalydeco to be taken with tezacaftor/ivacaftor, read the tezacaftor/ivacaftor package leaflet.
Slovenian: Če so vam predpisali zdravilo Kalydeco za jemanje s tezakaftorjem/ivakaftorjem, preberite navodilo za uporabo tezakaftorja/ivakaftorja.
English: Clinical efficacy in patients with the G970R mutation of the CFTR gene could not be established (see section 5.1).
Slovenian: Klinične učinkovitosti pri bolnikih z mutacijo G970R gena CFTR niso mogli dokazati (glejte poglavje 5.1).
English: The observed treatment difference (95% CI) between ivacaftor and placebo was 10.7% (7.3, 14.1) (P < 0.0001).
Slovenian: Opažena razlika zaradi zdravljenja (95 % IZ) med ivakaftorjem in placebom je bila 10,7 % (7,3; 14,1) (P < 0,0001).
English: Ivacaftor dosing was interrupted in most patients with transaminase elevations > 5 x ULN.
Slovenian: Zdravljenje z ivakaftorjem so prekinili pri večini bolnikov z zvišanji transaminaz > 5 x ULN.
English: • Herbal medicines such as St. John's wort (Hypericum perforatum)
Slovenian: • zdravila rastlinskega izvora, npr. šentjanževka (Hypericum perforatum);
English: When they rolled over into study 4, the rate of annualised pulmonary exacerbations was 0.91 events/year across day 1 to week 48 and 0.77 events/year across weeks 48 to 96.
Slovenian: Ko so prešli v študijo 4, je bila pogostnost pljučnih eksacerbacij, preračunana na leto, 0,91 dogodka/leto v obdobju med 1. dnem in 48. tednom in 0,77 dogodka/leto v obdobju med 48. in 96. tednom.
English: Thirty-nine patients (mean age 23 years) with baseline FEV1 ≥ 40% predicted (mean FEV1 78% predicted [range: 43% to 119%]) were enrolled.
Slovenian: Vključenih je bilo 39 bolnikov (povprečna starost 23 let) z izhodiščnim FEV1 ≥ 40 % napovedanega (povprečni FEV1 78 % napovedanega [razpon: 43 % do 119 %]).
English: The primary efficacy endpoint in both studies was the mean absolute change from baseline in percent predicted FEV1 through 24 weeks of treatment.
Slovenian: Primarni cilj študije glede učinkovitosti v obeh študijah je bila povprečna absolutna sprememba od izhodišča v odstotkih napovedanega FEV1 v obdobju 24 tednov zdravljenja.
English: In particular, tell your child's doctor if your child is taking any of the medicines listed below.
Slovenian: Še posebno povejte otrokovemu zdravniku, če otrok jemlje katero od spodaj navedenih zdravil.
English: In the cohort of patients aged 6 months to less than 12 months one patient (9.1%) had elevated ALT of > 3 to ≤5 x ULN.
Slovenian: V kohorti bolnikov, starih 6 mesecev do manj kot 12 mesecev, je imel en bolnik (9,1 %) zvišano ALT med > 3 do ≤ 5 x ULN.
English: BMI-for-age z-score at week 48e
Slovenian: ITM-za starost z-vrednost v tednu 48e
English: Potential for ivacaftor to interact with transporters
Slovenian: Potencial ivakaftorja za interakcije s prenašalci
English: In a human pharmacokinetic study, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Slovenian: V farmakokinetični študiji na ljudeh je bilo odstranjevanje ivakaftorja in njegovih presnovkov iz telesa z urinom minimalno (v urinu so prestregli samo 6,6 % celotne radioaktivnosti).
English: Ivacaftor is a sensitive CYP3A substrate.
Slovenian: Ivakaftor je občutljiv substrat CYP3A.
English: In vitro and in vivo data indicate that ivacaftor is primarily metabolised by CYP3A.
Slovenian: Podatki in vitro in in vivo kažejo, da ivakaftor presnavlja predvsem CYP3A.
English: • Feeling sick (nausea)
Slovenian: • občutek slabosti (navzea)
English: If your child has liver problems, either moderate or severe, your child's doctor may need to reduce the dose of Kalydeco as your child's liver will not clear the medicine as fast as in children who have normal liver function.
Slovenian: Če ima vaš otrok težave z delovanjem jeter, bodisi zmerne bodisi hude, bo otrokov zdravnik mogoče moral zmanjšati odmerek zdravila Kalydeco, ker jetra vašega otroka ne čistijo zdravila iz krvi tako hitro kot pri otrocih, ki imajo normalno delovanje jeter.
English: Transaminase elevations
Slovenian: Zvišanja transaminaz
English: CFQ-R respiratory domain score (points)
Slovenian: Rezultat respiracijske domene CFQ-R (točke)
English: BMI (kg/m2)
Slovenian: (kg/m2)
English: Two patients, one on placebo and one on ivacaftor, permanently discontinued treatment for elevated transaminases, each > 8 x ULN.
Slovenian: Dva bolnika, eden na placebu in eden na ivakaftorju, sta trajno prekinila zdravljenje zaradi zvišanih transaminaz, pri obeh so bile > 8 x ULN.
English: Patients in both studies were randomised 1:1 to receive either 150 mg of ivacaftor or placebo every 12 hours with food containing fat for 48 weeks in addition to their prescribed CF therapies (e.g., tobramycin, dornase alfa).
Slovenian: Bolnike v obeh študijah so randomizirali v razmerju 1:1 na 150 mg ivakaftorja ali placebo skupaj z obrokom, ki vsebuje maščobe, vsakih 12 ur za 48 tednov poleg njihovih predpisanih terapij CF (npr. tobramicin, dornaza alfa).
English: Ivacaftor was associated with slight decreases of the seminal vesicle weights, a decrease of overall fertility index and number of pregnancies in females mated with treated males and significant reductions in number of corpora lutea and implantation sites with subsequent reductions in the average litter size and average number of viable embryos per litter in treated females.
Slovenian: Ivakaftor je bil povezan z rahlim zmanjšanjem mase semenskih mešičkov, zmanjšanjem indeksa celotne plodnosti in števila brejosti pri samicah, ki so se sparile z zdravljenimi samci, in značilnim zmanjšanjem števila rumenih telesc in ugnezditvenih mest s posledičnim zmanjšanjem povprečne velikosti gnezda in povprečnega števila za življenje sposobnih zarodkov na gnezdo pri zdravljenih samicah.
English: Kalydeco in combination with tezacaftor/ivacaftor should not be prescribed in patients with CF who are heterozygous for the F508del mutation and have a second CFTR mutation not listed in section 4.1.
Slovenian: Zdravila Kalydeco v kombinaciji s tezakaftorjem/ivakaftorjem ne smemo predpisovati bolnikom s CF, ki so heterozigotni za mutacijo F508del in imajo drugo mutacijo CFTR, ki ni navedena v poglavju 4.1.
English: One tablet of tezacaftor 100 mg/ivacaftor 150 mg should be taken twice a week, taken approximately 3 to 4 days apart.
Slovenian: Eno tableto tezakaftorja 100 mg/ivakaftorja 150 mg je treba vzeti dvakrat na teden, presledek med njima naj bo 3 do 4 dni.
English: The apparent terminal half-life was approximately 12 hours following a single dose in the fed state.
Slovenian: Navidezni končni razpolovni čas je bil po enkratnem odmerku na poln želodec približno 12 ur.
English: Efficacy results from a Phase 2 study in patients with CF who are homozygous for the F508del mutation in the CFTR gene showed no statistically significant difference in FEV1 over 16 weeks of ivacaftor treatment compared to placebo (see section 5.1).
Slovenian: Rezultati učinkovitosti iz študije 2. faze pri bolnikih s CF, ki so homozigotni za mutacijo F508del na genu CFTR, niso pokazali statistično značilne razlike v FEV1 vseh 16 tednov zdravljenja z ivakaftorjem v primerjavi s placebom (glejte poglavje 5.1).
English: Study 7: study in paediatric patients with CF aged 2 to less than 6 years with G551D or another gating mutation
Slovenian: Študija 7: študija pri pediatričnih bolnikih s CF, starih od 2 leti do manj kot 6 let, z mutacijo G551D ali drugo mutacijo spreminjanja prehodnosti
English: Pregnancy and fertility
Slovenian: Nosečnost in plodnost
English: The safety and efficacy of Kalydeco in a combination regimen with tezacaftor/ivacaftor in children aged less than 12 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Kalydeco v kombinirani shemi s tezakaftorjem/ivakaftorjem pri otrocih, mlajših od 12 let, nista bili dokazani.
English: • Medicines for diabetes such as glimepiride and glipizide, used to lower sugar blood levels.
Slovenian: • zdravila za sladkorno bolezen, na primer glimepirid in glipizid, ki se uporabljajo za zniževanje ravni krvnega sladkorja.
English: At the 4-week follow-up visit (4 weeks after dosing with ivacaftor ended), mean sweat chloride values for each group were trending to pre-treatment levels.
Slovenian: Pri kontrolnem pregledu po 4 tednih (4 tedne po koncu odmerjanja z ivakaftorjem) so se povprečne vrednosti kloridov v znoju za vsako skupino približevale koncentracijam pred zdravljenjem.
English: Light blue, capsule-shaped film-coated tablets, printed with “V 150” in black ink on one side and plain on the other (16.5 mm x 8.4 mm in modified tablet shape).
Slovenian: Svetlo modre filmsko obložene tablete v obliki kapsule z natisnjenim napisom “V 150” s črnim črnilom na eni strani in brez napisa na drugi (16,5 mm x 8,4 mm v obliki modificirane tablete).
English: One hundred and forty-four (144) patients from study 1 were rolled over in study 4, 67 in the placebo/ivacaftor group and 77 in the ivacaftor/ivacaftor group.
Slovenian: Sto štiriinštirideset (144) bolnikov iz študije 1 je prešlo v študijo 4, 67 v skupino placebo/ivakaftor in 77 v skupino ivakaftor/ivakaftor.
English: Forty-eight (48) patients from study 2 were rolled over in study 4, 22 in the placebo/ivacaftor group and 26 in the ivacaftor/ivacaftor group.
Slovenian: Oseminštirideset (48) bolnikov iz študije 2 je prešlo v študijo 4, 22 v skupino placebo/ivakaftor in 26 v skupino ivakaftor/ivakaftor.
English: In vitro responses seen in single channel patch clamp experiments using membrane patches from rodent cells expressing mutant CFTR forms do not necessarily correspond to in vivo pharmacodynamic response (e.g., sweat chloride) or clinical benefit.
Slovenian: Ni nujno, da odzivi in vitro, ugotovljeni v poskusih z enokanalnim ojačevalnikom »patch clamp«, v katerih so bile uporabljene površine membran glodavskih celic z izraženimi mutantnimi oblikami CFTR, ustrezajo farmakodinamičnemu odzivu in vivo (npr. kloridom v znoju) ali klinični koristi.
English: If you have been told by your child's doctor that your child has an intolerance to some sugars, contact your child's doctor before your child takes this medicine.
Slovenian: Če vam je otrokov zdravnik povedal, da ima vaš otrok intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z otrokovim zdravnikom.
English: Through week 24
Slovenian: V 24. tednu
English: Give the missed dose if less than 6 hours have passed since the time your child missed the dose.
Slovenian: Otroku dajte izpuščeni odmerek, če je preteklo manj kot 6 ur od takrat, ko ste izpustili otrokov odmerek.
English: The recommended dose of Kalydeco is one 150 mg tablet every 12 hours (in total 2 tablets: 300 mg per day).
Slovenian: Priporočeni odmerek zdravila Kalydeco je ena 150-miligramska tableta vsakih 12 ur (skupaj 2 tableti: 300 mg na dan).
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for your child.
Slovenian: Preden bo vaš otrok začel jemati zdravilo, natančno preberite navodilo, ker vsebuje za vašega otroka pomembne podatke!
English: Administration of ivacaftor may increase systemic exposure of medicinal products that are sensitive substrates of CYP2C9, and/or P-gp, and/or CYP3A which may increase or prolong their therapeutic effect and adverse reactions.
Slovenian: Uporaba ivakaftorja lahko zveča sistemsko izpostavljenost zdravilom, ki so občutljivi substrati CYP2C9 in/ali P-gp in/ali CYP3A, kar lahko zveča ali podaljša njihov terapevtski učinek in neželene učinke.
English: In children aged 6 to less than 12 years, the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 15.0% (6/40) in ivacaftor-treated patients and 14.6% (6/41) in patients who received placebo.
Slovenian: Pri otrocih, starih od 6 do manj kot 12 let, je bila pogostost bolnikov z zvišanjem transaminaz (ALT ali AST) > 3 x ULN 15,0 % (6/40) pri tistih, zdravljenih z ivakaftorjem, in 14,6 % (6/41) pri bolnikih, ki so prejemali placebo.
English: The recommended dose of Kalydeco in combination with tezacaftor/ivacaftor is one tezacaftor/ivacaftor tablet in the morning and one Kalydeco 150 mg tablet in the evening.
Slovenian: Priporočeni odmerek zdravila Kalydeco v kombinaciji s tezakaftorjem/ivakaftorjem je ena tableta tezakaftorja/ivakaftorja zjutraj in ena 150-miligramska tableta zdravila Kalydeco zvečer.
English: Ivacaftor is a potentiator of the CFTR protein, i.e., in vitro ivacaftor increases CFTR channel gating to enhance chloride transport in specified gating mutations (as listed in section 4.1) with reduced channel-open probability compared to normal CFTR.
Slovenian: Ivakaftor je ojačevalec beljakovine CFTR, t.j., ivakaftor in vitro zvečuje prehodnost kanalčkov CFTR in tako zveča transport kloridov pri določenih mutacijah spreminjanja prehodnosti (navedenih v poglavju 4.1) z zmanjšano verjetnostjo odprtih kanalčkov v primerjavi z normalnim CFTR.
English: Simulations for predicting the steady-state exposure of ivacaftor showed that by reducing the dosage from 150 mg q12h to 150 mg once daily, adults with moderate hepatic impairment would have comparable steady-state Cmin values as those obtained with a dose of 150 mg q12h in adults without hepatic impairment.
Slovenian: Simulacije napovedovanja izpostavljenosti ivakaftorju v stanju dinamičnega ravnovesja so pokazale, da bi z zmanjšanjem odmerjanja s 150 mg na 12 ur na 150 mg enkrat na dan imeli odrasli bolniki z zmerno okvaro jeter primerljive vrednosti Cmin v stanju dinamičnega ravnovesja kot tiste, ki jih dobimo z odmerkom 150 mg na 12 ur pri odraslih bolnikih brez okvare jeter.
English: In a human pharmacokinetic study with ivacaftor monotherapy, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Slovenian: V farmakokinetični študiji na ljudeh z monoterapijo z ivakaftorjem je bilo odstranjevanje ivakaftorja in njegovih presnovkov iz telesa z urinom minimalno (v urinu so prestregli samo 6,6 % celotne radioaktivnosti).
English: Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance).
Slovenian: Ivakaftor je tudi zvečal verjetnost odprtih kanalčkov pri R117H-CFTR, kjer je tako majhna verjetnost odprtih kanalčkov (spremenjena prehodnost kanalčkov celične membrane) kot tudi zmanjšana amplituda toka kanalčkov (prevodnost).
English: The efficacy of Kalydeco monotherapy in patients less than 18 years of age with an R117H mutation in the CFTR gene has not been established.
Slovenian: Učinkovitost monoterapije z zdravilom Kalydeco pri bolnikih, mlajših od 18 let, z mutacijo R117H na genu CFTR ni bila dokazana.
English: Predicted ivacaftor exposure based on observed ivacaftor concentrations in Phase 2 and 3 studies as determined using population PK analysis is presented by age group in Table 7.
Slovenian: Napovedana izpostavljenost ivakaftorju, ki temelji na ugotovljenih koncentracijah ivakaftorja v študijah 2. in 3. faze s populacijsko farmakokinetično (FK) analizo, je prikazana po starostnih skupinah v preglednici 7.
English: The mean change from baseline through week 24 in FEV1 (L) was 0.37 L in the ivacaftor group and 0.01 L in the placebo group in study 1 and 0.30 L in the ivacaftor group and 0.07 L in the placebo group in study 2.
Slovenian: Povprečna sprememba FEV1 (l) od izhodišča do 24. tedna je bila 0,37 l v skupini z ivakaftorjem in 0,01 l v skupini s placebom v študiji 1 in 0,30 l v skupini z ivakaftorjem in 0,07 l v skupini s placebom v študiji 2.
English: Your child's doctor may decide to adjust your child's dose or if extra check-ups are needed.
Slovenian: Otrokov zdravnik se bo mogoče odločil, da bo otroku prilagodil odmerek ali da otrok potrebuje dodatne kontrolne preglede.
English: Results were consistent in both the 12 months to less than 24 months and 6 months to less than 12 months age cohorts.
Slovenian: Rezultati so se ujemali v starostnih kohortah 12 mesecev do manj kot 24 mesecev in 6 mesecev do manj kot 12 mesecev.
English: After steady-state dosing of ivacaftor in combination with tezacaftor in CF patients, the mean (SD) terminal half-life of ivacaftor was approximately 9.3 (1.7) hours.
Slovenian: Po odmerjanju ivakaftorja v kombinaciji z tezakaftorjem bolnikom s CF v stanju dinamičnega ravnovesja je bila povprečna (SD) končna razpolovna doba ivakaftorja približno 9,3 (1,7) ure.
English: • Immunosuppressants such as ciclosporin, tacrolimus, everolimus and sirolimus used after an organ transplantation
Slovenian: • imunosupresivi, na primer ciklosporin, takrolimus, everolimus in sirolimus, ki se uporabljajo po presaditvi organov;
English: The mean (SD) overall change in percent predicted FEV1 from baseline at week 24 (exploratory endpoint) was 1.8 (17.81).
Slovenian: Povprečna (SD) celotna sprememba odstotka napovedanega FEV1 od izhodišča v 24. tednu (eksploratorno končno stanje) je bila 1,8 (17,81).
English: After oral administration of a single 150 mg dose to healthy volunteers in a fed state, the mean (± SD) for AUC and Cmax were 10600 (5260) ng*hr/mL and 768 (233) ng/mL, respectively.
Slovenian: Po peroralni aplikaciji enega samega 150-miligramskega odmerka zdravim prostovoljcem po obroku je bilo povprečje (± SD) za AUC in Cmax 10.600 (5.260) ng*h/ml oziroma 768 (233) ng/ml.
English: Gender The pharmacokinetic parameters of ivacaftor are similar in males and females.
Slovenian: Farmakokinetični parametri ivakaftorja so podobni pri moških in ženskah.
English: 4 individual wallets with 14 sachets per wallet
Slovenian: 4 posamezne pretisne zgibanke s po 14 vrečicami na zgibanko
English: Ivacaftor granules (2 x 75 mg sachets) had similar bioavailability as the 150 mg tablet when given with fat-containing food to healthy adult subjects.
Slovenian: Zrnca ivakaftorja (vrečke z 2 x 75 mg) so imela podobno biološko uporabnost kot 150-miligramske tablete, ko so jih z obrokom hrane, ki vsebuje maščobe, dajali zdravim odraslim preiskovancem.
English: Lactose content
Slovenian: Vsebnost laktoze
English: Table 8: Mean (SD) of ivacaftor exposure when used in combination with tezacaftor, by age group
Slovenian: Preglednica 8: Povprečna (SD) izpostavljenost ivakaftorju, kadar ga dajemo v kombinaciji s tezakaftorjem, po starostnih skupinah