natgillin/translations-raw huggingface dataset:
• Antibacterial agents such as telithromycin, clarithromycin, erythromycin, rifampicin and rifabutin, used for the treatment of bacterial infections
• antibiotiki, na primer telitromicin, klaritromicin, eritromicin, rifampicin in rifabutin, ki se uporabljajo za zdravljenje bakterijskih okužb;
Table 3: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Preglednica 3: Vpliv ivakaftorja na druge cilje učinkovitosti v študijah 1 in 2
For patients randomised to the placebo/ivacaftor treatment sequence in part 1 there was a further mean (SD) change of 3.3% (9.3%) in percent predicted FEV1 after the additional 16 weeks of treatment with ivacaftor.
Pri bolnikih, randomiziranih na zaporedje zdravljenja placebo/ivakaftor v prvem delu, so po dodatnih 16 tednih zdravljenja z ivakaftorjem ugotovili še dodatno povprečno (SD) spremembo 3,3 % (9,3 %) napovedanega FEV1 v odstotkih.
In study 5, part 1 in patients who had a non-G551D gating mutation in the CFTR gene, treatment with ivacaftor led to a rapid (15 days) and substantial mean change from baseline in sweat chloride of -49 mmol/L (95% CI -57, -41) through 8 weeks of treatment.
V prvem delu študije 5 pri bolnikih, ki so imeli ne-G551D mutacijo spreminjanja prehodnosti v genu CFTR, je zdravljenje z ivakaftorjem povzročilo hitro (15 dni) in znatno povprečno spremembo kloridov v znoju od izhodišča za -49 mmol/l (95 % IZ -57, -41) v 8 tednih zdravljenja.
The treatment difference for ivacaftor versus placebo was -6.3 percentage points (95% CI -12.0, -0.7).
Razlika zaradi zdravljenja z ivakaftorjem proti placebu je bila -6,3 odstotne točke (95 % IZ -12,0; -0,7).
Co-administration of ivacaftor with rifampicin, a strong CYP3A inducer, decreased ivacaftor exposure (AUC) by 89% and decreased hydroxymethyl ivacaftor (M1) to a lesser extent than ivacaftor.
Sočasna uporaba ivakaftorja z rifampicinom, ki je močan spodbujevalec CYP3A, je zmanjšala izpostavljenost (AUC) ivakaftorju za 89 % in zmanjšala hidroksimetil-ivakaftor (M1) v manjši meri kot ivakaftor.
No dose adjustment of CYP3A substrates, such as midazolam, alprazolam, diazepam or triazolam, is required when these are coadministered with ivacaftor.
Prilagajanje odmerkov substratov CYP3A, na primer midazolama, alprazolama, diazepama ali triazolama, ni potrebno, kadar jih dajete sočasno z ivakaftorjem.
No patients had elevations in total bilirubin or discontinued ivacaftor treatment due to transaminase elevations in either cohort.
Pri nobenem bolniku ni bil zvišan celotni bilirubin in noben bolnik v nobeni od kohort ni prekinil zdravljenja z ivakaftorjem zaradi zvišanja transaminaz.
150 mg q12h 958 (546)
150 mg na 12h 958 (546)
It is unknown whether ivacaftor and/or its metabolites are excreted in human milk.
Ni znano, ali se ivakaftor/presnovki izločajo v materino mleko.
In study 4, patients who completed treatment in studies 1 and 2 with placebo were switched to ivacaftor while patients on ivacaftor continued to receive it for a minimum of 96 weeks, i.e., the length of treatment with ivacaftor was at least 96 weeks for patients in the placebo/ivacaftor group and at least 144 weeks for patients in the ivacaftor/ivacaftor group.
V študiji 4 so bolniki, ki so dokončali zdravljenje v študijah 1 in 2 s placebom, prešli na ivakaftor, medtem ko so bolniki, ki so prejemali ivakaftor, to zdravilo prejemali še najmanj 96 tednov, t.j., dolžina zdravljenja z ivakaftorjem je bila pri bolnikih v skupini s placebom in ivakaftorjem vsaj 96 tednov, v skupini z ivakaftorjem in ivakaftorjem pa vsaj 144 tednov.
Kalydeco is for oral use.
Zdravilo Kalydeco je namenjeno za peroralno uporabo.
No dose adjustments are recommended for mild and moderate renal impairment.
Pri blagi in zmerni okvari ledvic prilagajanja odmerkov ne priporočajo.
At baseline, mean predicted FEV1 was 63.6% (range: 31.6% to 98.2%) and mean age was 26 years (range: 12 to 53 years).
V izhodišču je bil povprečni napovedani FEV1 63,6 % (razpon: 31,6 % do 98,2 %), povprečna starost je bila 26 let (razpon: 12 do 53 let).
The estimated treatment difference for ivacaftor versus placebo was 5.0 percentage points (95% CI 1.1, 8.8).
Ocenjena razlika zaradi zdravljenja z ivakaftorjem proti placebu je bila 5,0 odstotne točke (95 % IZ 1,1; 8,8).
Refer to the Summary of Product Characteristics of tezacaftor/ivacaftor for additional data.
Za dodatne podatke glejte povzetek glavnih značilnosti zdravila tezakaftor/ivakaftor.
50 mg q12h 577 (317)
50 mg na 12h 577 (317)
Table 7: Mean (SD) ivacaftor exposure by age group Age group
Preglednica 7: Povprečna (SD) izpostavljenost ivakaftorju po starostnih skupinah Starostna skupina
Table 4: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Preglednica 4: Vpliv ivakaftorja na druge cilje učinkovitosti v študijah 1 in 2
50 mg q12h 440 (212)
50 mg na 12h 440 (212)
If the patient's genotype is unknown, an accurate and validated genotyping method should be performed before starting treatment to confirm the presence of an indicated mutation in the CFTR gene (see section 4.1).
Če bolnikov genotip ni znan, je treba pred začetkom zdravljenja z natančno in validirano metodo genotipizacije potrditi prisotnost mutacije z indikacijo na genu CFTR (glejte poglavje 4.1).
The safety and efficacy of Kalydeco monotherapy in children aged less than 6 months with a gating (class III) mutation have not been established.
Varnost in učinkovitost monoterapije z zdravilom Kalydeco pri otrocih, mlajših od 6 mesecev, z eno od mutacij spreminjanja prehodnosti kanalčkov celične membrane (skupina III), nista bili dokazani.
• Antifungal medicines such as ketoconazole, itraconazole, posaconazole, voriconazole and fluconazole, used for the treatment of fungal infections
• Protiglivična zdravila, na primer ketokonazol, itrakonazol, posakonazol, vorikonazol in flukonazol, ki se uporabljajo za zdravljenje glivičnih okužb;
What you need to know before you take Kalydeco Do not take Kalydeco
Kaj morate vedeti, preden boste vzeli zdravilo Kalydeco Ne jemljite zdravila Kalydeco
A fat-containing meal or snack should be consumed just before or just after dosing.
Obrok ali prigrizek hrane, ki vsebuje maščobe, naj otrok zaužije tik pred odmerjanjem ali tik po njem.
If you forget to take Kalydeco
Če ste pozabili vzeti zdravilo Kalydeco
For patients aged 6 months to less than 24 months, with both baseline and week 24 values available, mean (SD) weight-for-age, length-for-age, and weight-for-length z-scores are provided in Table 6.
Za bolnike, stare 6 mesecev do manj kot 24 mesecev, za katere so bile na voljo tako izhodiščne vrednosti kot vrednosti v 24. tednu, preglednica 6 kaže povprečne (SD) z-vrednosti telesne mase za starost, telesne dolžine za starost in telesne mase za telesno dolžino.
In almost all instances where dosing was interrupted for elevated transaminases and subsequently resumed, ivacaftor dosing was able to be resumed successfully (see section 4.4).
V skoraj vseh primerih, ko je bilo odmerjanje prekinjeno zaradi zvišanih transaminaz, pozneje pa se je spet začelo, je bil ponovni začetek odmerjanja ivakaftorja uspešen (glejte poglavje 4.4).
Ivacaftor is extensively metabolised in humans.
Ivakaftor se pri ljudeh izdatno presnavlja.
No patients discontinued ivacaftor treatment due to transaminase elevations.
Noben bolnik ni prekinil zdravljenja z ivakaftorjem zaradi zvišanja transaminaz.
Following a single dose of 150 mg of ivacaftor, adult subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had similar ivacaftor Cmax (mean [± SD] of 735 [331] ng/mL) but an approximately two-fold increase in ivacaftor AUC0-∞ (mean [± SD] of 16800 [6140] ng*hr/mL) compared with healthy subjects matched for demographics.
Po enkratnem odmerku 150 mg ivakaftorja so odrasli bolniki z zmerno zmanjšano funkcijo jeter (razred B po Child-Pughovi lestvici, rezultat 7 do 9) imeli podobno Cmax ivakaftorja (povprečje [± SD] 735 [331] ng/ml), a približno dvakrat večjo AUC0-∞ ivakaftorja (povprečje [± SD] 16.800 [6.140] ng*h/ml) kot zdravi preiskovanci z enakimi demografskimi podatki.
The recommended dose is one Kalydeco 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food (see Method of administration).
Priporočeni odmerek je ena tableta zdravila Kalydeco 150 mg peroralno vsakih 12 ur (skupni dnevni odmerek 300 mg) z obrokom hrane, ki vsebuje maščobe (glejte Način uporabe).
• Increased liver enzymes in the blood have been seen in some people receiving Kalydeco.
• Pri nekaterih ljudeh, ki jemljejo zdravilo Kalydeco, so opazili zvišane jetrne encime v krvi.
The other ingredients are: silica, colloidal anhydrous , croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose and sodium laurilsulfate (E487).
Druge sestavine zdravila so: koloidni brezvodni silicijev dioksid, premrežen natrijev karmelozat, hipromeloza acetat sukcinat, laktoza monohidrat, magnezijev stearat, manitol, sukraloza in natrijev lavrilsulfat (E487).
The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 5.
Učinek ivakaftorja v celotni populaciji študije 5 (vključno s sekundarnima ciljema absolutno spremembo indeksa telesne mase (ITM) po 8 tednih zdravljenja in absolutno spremembo rezultata v respiracijski domeni CFQ-R po 8 tednih zdravljenja) in po posameznih mutacijah (absolutna sprememba kloridov v znoju in v odstotkih napovedanega FEV1 v 8. tednu) kaže preglednica 5.
Moderate transaminase (alanine transaminase [ALT] or aspartate transaminase [AST]) elevations are common in subjects with CF. Transaminase elevations have been observed in some patients treated with ivacaftor monotherapy.
Zmerno zvišanje transaminaz (alanin-aminotransferaza [ALT] ali aspartat-aminotransferaza [AST]) je pri bolnikih s CF pogosto.
150 mg q12h 564 (242)
150 mg na 12h 564 (242)
• Talk to your child's doctor if you have been told your child has kidney problems, or has previously had them.
• Posvetujte se z otrokovim zdravnikom, če so vam povedali, da vaš otrok ima ali je kdaj prej imel težave z ledvicami.
2- to 5-year-olds (< 14 kg)
2 do 5 let stari otroci (< 14 kg)
The safety data of ivacaftor were evaluated in 11 patients between 6 months to less than 12 months of age, 19 patients between 12 months to less than 24 months of age, 34 patients between 2 to less than 6 years of age, 61 patients between 6 to less than 12 years of age and 94 patients between 12 to less than 18 years of age.
Varnostne podatke ivakaftorja so ovrednotili pri 11 bolnikih med 6 meseci in manj kot 12 meseci starosti, pri 19 bolnikih med 12 meseci in manj kot 24 meseci starosti, pri 34 bolnikih med 2 in manj kot 6 leti starosti, pri 61 bolnikih med 6 in manj kot 12 leti starosti in pri 94 bolnikih med 12 in manj kot 18 leti starosti.
• Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents during treatment.
• Pri nekaterih otrocih in mladostnikih so med zdravljenjem opazili nenormalnost očesne leče (katarakta) brez vpliva na vid.
The safety data of ivacaftor monotherapy were evaluated in 11 patients between 6 months to less than 12 months of age, 19 patients between 12 months to less than 24 months of age, 34 patients between 2 to less than 6 years of age, 61 patients between 6 to less than 12 years of age and 94 patients between 12 to less than 18 years of age.
Varnostne podatke monoterapije z ivakaftorjem so ovrednotili pri 11 bolnikih med 6 meseci in manj kot 12 meseci starosti, pri 19 bolnikih med 12 meseci in manj kot 24 meseci starosti, pri 34 bolnikih med 2 in manj kot 6 leti starosti, pri 61 bolnikih med 6 in manj kot 12 leti starosti in pri 94 bolnikih med 12 in manj kot 18 leti starosti.
Food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.5).
Med zdravljenjem se je treba izogibati hrani in pijači, ki vsebujeta grenivke ali grenke pomaranče (glejte poglavje 4.5).
• Cheese, whole milk, whole-milk dairy products, yogurt, breast milk, infant formula, chocolate
• sir, neposneto mleko, mlečni izdelki iz neposnetega mleka, jogurt, materino mleko, adaptirano mleko za dojenčke, čokolada
Therefore, co-administration of Kalydeco with strong CYP3A inducers is not recommended (see section 4.5).
Zato sočasna uporaba zdravila Kalydeco z močnimi induktorji CYP3A ni priporočljiva (glejte poglavje 4.5).
When co-administered with moderate inhibitors of CYP3A, the dose of Kalydeco and tezacaftor/ivacaftor should be adjusted according to the recommendations in Table 1 (see section 4.4 and 4.5).
Kadar dajemo zdravilo Kalydeco skupaj z zmernimi zaviralci CYP3A, moramo odmerek zdravila Kalydeco in tezakaftorja/ivakaftorja prilagoditi v skladu s priporočili v preglednici 1 (glejte poglavji 4.4 in 4.5).
Avoid giving your child food or drink containing grapefruit or Seville oranges during treatment with Kalydeco as they may increase the side effects of Kalydeco by increasing the amount of ivacaftor in your child's body.
Med zdravljenjem z zdravilom Kalydeco ne dajajte otroku hrane ali pijače, ki vsebuje grenivke ali grenke pomaranče, ker bi lahko zvečali neželene učinke zdravila Kalydeco, tako da bi zvečali količino ivakaftorja v otrokovem telesu.
In patients heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity, the treatment difference in mean absolute change from baseline in sweat chloride through week 8 was -9.5 mmol/L (95% CI: -11.7, -7.3) between ivacaftor in combination with tezacaftor/ivacaftor and placebo, and -4.5 mmol/L (95% CI: -6.7, -2.3) between ivacaftor and placebo.
Pri bolnikih, heterozigotnih za mutacijo F508del, ki so imeli še drugo mutacijo, povezano z rezidualno aktivnostjo CFTR, je bila razlika zaradi zdravljenja, izražena kot povprečna absolutna sprememba kloridov v znoju od izhodišča do vključno 8. tedna, -9,5 mmol/l (95 % IZ: -11,7; -7,3) med ivakaftorjem v kombinaciji s tezakaftorjem/ivakaftorjem in placebom, in -4,5 mmol/l (95 % IZ: -6,7; -2,3) med ivakaftorjem in placebom.
The dose of Kalydeco must be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see sections 4.2 and 4.5).
Odmerek zdravila Kalydeco je treba prilagoditi, kadar ga uporabljamo sočasno z močnimi ali zmernimi zaviralci CYP3A (glejte poglavji 4.2 in 4.5).
If not immediately consumed, the mixture has been shown to be stable for one hour and therefore should be ingested during this period.
Izkazalo se je, da je mešanica obstojna še eno uro, zato jo je treba zaužiti vsaj v tem času, če je otrok ne zaužije takoj.
In study 6 in patients aged 6 years or older with CF who had an R117H mutation in the CFTR gene, the treatment difference in mean change in sweat chloride from baseline through 24 weeks of treatment was -24 mmol/L (95% CI -28, -20).
V študiji 6 pri bolnikih, starih 6 let ali več, s CF, ki so imeli mutacijo R117H na genu CFTR, je bila razlika zaradi zdravljenja povprečne spremembe kloridov v znoju od izhodišča po 24 tednih zdravljenja -24 mmol/l (95 % IZ -28, -20).
The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 4.
Učinek ivakaftorja v celotni populaciji študije 5 (vključno s sekundarnima ciljema absolutno spremembo indeksa telesne mase (ITM) po 8 tednih zdravljenja in absolutno spremembo rezultata v respiracijski domeni CFQ-R po 8 tednih zdravljenja) in po posameznih mutacijah (absolutna sprememba kloridov v znoju in v odstotkih napovedanega FEV1 v 8. tednu) kaže preglednica 4.
In all instances where dosing was interrupted for elevated transaminases and subsequently resumed, ivacaftor dosing was able to be resumed successfully (see section 4.4).
V vseh primerih, ko je bilo odmerjanje prekinjeno zaradi zvišanih transaminaz, pozneje pa se je spet začelo, je bil ponovni začetek odmerjanja ivakaftorja uspešen (glejte poglavje 4.4).
The pharmacokinetic profile, safety, and efficacy of ivacaftor in patients with CF aged 6 months to less than 24 months were assessed in a completed cohort of patients in an on-going 24-week, open-label, Phase 3 clinical study in patients aged less than 24 months (study 8).
Študija 8: študija pri pediatričnih bolnikih s CF, starih manj kot 24 mesecev Farmakokinetični profil, varnost in učinkovitost ivakaftorja pri bolnikih s CF, starih 6 mesecev do manj kot 24 mesecev, so ocenili v dokončni kohorti bolnikov v 24-tedenski odprti klinični študiji 3. faze, ki še poteka, pri bolnikih, mlajših od 24 mesecev (študija 8).
Kalydeco 50 mg granules
Kalydeco 50 mg zrnca
Morning Dose
zjutraj zvečer
Uncommon side effects (may affect up to 1 in 100 people)
Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov)
Findings of cataracts were observed in juvenile rats dosed from postnatal day 7 through 35 at ivacaftor exposure levels of 0.22 times the MRHD based on systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy.
Pri mladih podganah, ki so od 7. do 35. dneva po rojstvu prejemale odmerke ivakaftorja pri ravneh izpostavljenosti ivakaftorju, ki so bile 0,22-kratnik MHRD na podlagi sistemske izpostavljenosti ivakaftorju in njegovim presnovkom, ko so ga dajali kot monoterapijo z ivakaftorjem, so opažali katarakto.
In study 8 in patients with CF aged less than 24 months, the mean absolute change from baseline in sweat chloride was -67.9 mmol/L (95% CI -77.6, -58.2) at week 24.
V študiji 8 pri bolnikih s CF, starih manj kot 24 mesecev, je bila povprečna absolutna sprememba klorida v znoju od izhodišča v 24. tednu -67,9 mmol/l (95 % IZ -77,6; -58,2).
Co-administration with (oral) midazolam, a sensitive CYP3A substrate, increased midazolam exposure 1.5-fold, consistent with weak inhibition of CYP3A by ivacaftor.
Sočasna uporaba s (peroralnim) midazolamom, ki je občutljiv substrat CYP3A, je zvečala izpostavljenost midazolamu za 1,5-krat, kar se ujema z dejstvom, da je ivakaftor šibek zaviralec CYP3A.
Pharmacokinetic studies have not been performed with ivacaftor in patients with renal impairment, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor.
Farmakokinetičnih študij z ivakaftorjem pri bolnikih z okvarami ledvic niso opravili niti z monoterapijo niti s kombinirano shemo s tezakaftorjem/ivakaftorjem.
See section 4.5 for interactions with ciclosporin or tacrolimus.
Za medsebojno delovanje s ciklosporinom ali takrolimusom glejte poglavje 4.5.
• Loss of appetite
• izguba teka,
Absolute change from baseline in percent predicted FEV1 (percentage points) N
Absolutna sprememba od izhodišča v odstotkih napovedanega FEV1 (odstotne točke)
No dose adjustment of CYP3A substrates, such as midazolam, alprazolam, diazepam or triazolam, is required when these are co-administered with ivacaftor (as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Prilagajanje odmerkov substratov CYP3A, na primer midazolama, alprazolama, diazepama ali triazolama, ni potrebno, kadar jih dajete sočasno z ivakaftorjem (bodisi samim bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem).
After oral administration of ivacaftor 150 mg every 12 hours in combination with tezacaftor 100 mg once daily in patients with CF in the fed state, the mean (± SD) for apparent clearance of ivacaftor was 15.7 (6.38) L/h.
Po peroralnem dajanju 150 mg ivakaftorja vsakih 12 ur skupaj s 100 mg tezakaftorja enkrat na dan bolnikom s CF v stanju sitosti je bil povprečni (± SD) navidezni očistek ivakaftorja 15,7 (6,38) l/h.
After oral administration of ivacaftor 150 mg every 12 hours in combination with tezacaftor 100 mg once daily in patients with CF in the fed state, the mean (± SD) for apparent volume of distribution of ivacaftor was 206 (82.9) L.
Po peroralnem dajanju 150 mg ivakaftorja vsakih 12 ur v kombinaciji s 100 mg tezakaftorja enkrat na dan bolnikom s CF v stanju sitosti je bil povprečni (± SD) navidezni volumen porazdelitve ivakaftorja 206 (82,9) l.
What you need to know before your child takes Kalydeco 3.
Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Kalydeco 3.
Kalydeco 25 mg granules in sachet Kalydeco 50 mg granules in sachet Kalydeco 75 mg granules in sachet
Kalydeco 25 mg zrnca v vrečici Kalydeco 50 mg zrnca v vrečici Kalydeco 75 mg zrnca v vrečici
• Severe liver problems: the use is not recommended but your child's doctor will decide if it is appropriate for your child to use this medicine in which case the dose (as indicated in the table above) must be reduced to one sachet every other day.
• Hude težave z jetri: uporabe ne priporočajo, vendar bo otrokov zdravnik odločil, ali je primerno,
At week 8
v 8. tednu v 8. tednu
Table 1: Dosing recommendations for concomitant use with moderate CYP3A inhibitors Day 1 Day 2 Day 3 Day 4*
Preglednica 1: Priporočila za odmerjanje pri sočasni uporabi z zmernimi zaviralci CYP3A
Therefore, its use is not recommended unless the benefits outweigh the risks (see Table 2 and sections 4.4 and 5.2).
Zato uporabe tega zdravila ne priporočajo, razen če koristi zdravljenja odtehtajo tveganje (glejte preglednico 2 in poglavji 4.4 in 5.2).
Severe (Child-Pugh Class C)
Težke (razred C po Child-Pughovi lestvici)
Ivacaftor was administered orally every 12 hours with fat-containing food.
Ivakaftor so jemali peroralno vsakih 12 ur z mastno hrano.
• If you have any further questions, ask your child's doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z otrokovim zdravnikom ali farmacevtom.
Kalydeco tablets should be taken with fat-containing food.
Tablete Kalydeco je treba jemati z obrokom hrane, ki vsebuje maščobe.
How to take Kalydeco
Kako jemati zdravilo Kalydeco
S549R (4)
G970R # (4)
Take with fat-containing food.
Jemljite z obrokom hrane, ki vsebuje maščobe.
The mean (± SD) CL/F for a single 150 mg dose was 17.3 (8.4) L/hr in healthy subjects.
Povprečje (± SD) CL/F za enkratni 150-miligramski odmerek je bilo pri zdravih preiskovancih 17,3 (8,4) l/h.
The NOAEL for viability and growth in the offspring provides an exposure level approximately 3 times the systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy in adult humans at the MRHD.
NOAEL za sposobnost za življenje in rast potomstva je dala raven izpostavljenosti, ki je približno trikratnik sistemske izpostavljenosti ivakaftorju in njegovim presnovkom, kadar so ga dajali kot monoterapijo z ivakaftorjem odraslim ljudem v MHRD.
During the 24-week, open-label, Phase 3 clinical study of ivacaftor in patients aged less than 24 months (study 8), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3, > 5, and > 8 x ULN in the cohort of patients aged 12 months to less than 24 months was 27.8% (5/18), 11.1% (2/18) and 11.1% (2/18), respectively.
Med 24-tedensko odprto klinično študijo z ivakaftorjem 3. faze pri bolnikih, mlajših od 24 mesecev (študija 8), je bila pogostnost bolnikov, ki so imeli zvišanja transaminaz (ALT ali AST) > 3, > 5 in > 8 x ULN, v kohorti bolnikov, starih 12 mesecev do manj kot 24 mesecev, 27,8 % (5/18), 11,1 % (2/18) oziroma 11,1 % (2/18).
75 mg q12h 641 (329)
75 mg na 12h 641 (329)
Co-administration of Kalydeco with strong CYP3A inducers, such as rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort (Hypericum perforatum), is not recommended (see section 4.4).
Sočasna uporaba zdravila Kalydeco z močnimi spodbujevalci CYP3A, kot so rifampicin, rifabutin, fenobarbital, karbamazepin, fenitoin in šentjanževka (Hypericum perforatum), ni priporočljiva (glejte poglavje 4.4).