natgillin/translations-raw huggingface dataset:
Co-administration of Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) 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 (bodisi samega bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) z močnimi spodbujevalci CYP3A, kot so rifampicin, rifabutin, fenobarbital, karbamazepin, fenitoin in šentjanževka (Hypericum perforatum), ni priporočljiva (glejte poglavje 4.4).
The dose of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) must be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see sections 4.2 and 4.5). 
Odmerek zdravila Kalydeco (monoterapija ali v kombinaciji s tezakaftorjem/ivakaftorjem) je treba prilagoditi, kadar ga uporabljamo sočasno z močnimi ali zmernimi zaviralci CYP3A (glejte poglavji 4.2 in 4.5).
If you have any further questions on the use of this medicine, ask your child's doctor or pharmacist. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z otrokovim zdravnikom ali farmacevtom.
No safety data are available in infants aged 6 to less than 12 months of age with moderate or severe hepatic impairment treated with ivacaftor. 
Pri dojenčkih, starih 6 mesecev do manj kot 12 mesecev, z zmerno ali težko okvaro jeter, zdravljenih z ivakaftorjem, podatkov o varnosti ni na voljo.
Therefore, co-administration of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) with strong CYP3A inducers is not recommended (see section 4.5). 
Zato sočasna uporaba zdravila Kalydeco (monoterapija ali v kombinaciji s tezakaftorjem/ivakaftorjem) z močnimi induktorji CYP3A ni priporočljiva (glejte poglavje 4.5).
Table 3: Adverse reactions in patients treated with ivacaftor monotherapy or in combination with tezacaftor System organ class 
Preglednica 3: Neželeni učinki pri bolnikih, zdravljenih z monoterapijo z ivakaftorjem ali v kombinaciji s tezakaftorjem
In study 7 in patients aged 2 to less than 6 years with a gating mutation on at least 1 allele of the CFTR gene administered either 50 mg or 75 mg of ivacaftor twice daily, the mean absolute change from baseline in sweat chloride was -47 mmol/L (95% CI -58, -36) at week 24. 
V študiji 7 pri bolnikih, starih 2 leti do manj kot 6 let, z mutacijo spreminjanja prehodnosti kanalčkov celične membrane na vsaj 1 alelu gena CFTR, ki so prejemali bodisi 50 mg bodisi 75 mg ivakaftorja dvakrat na dan, je bila po 24 tednih povprečna absolutna sprememba kloridov v znoju od izhodišča 47 mmol/l (95 % IZ -58, -36).
Ivacaftor, administered as monotherapy or in combination with tezacaftor, should be administered with fat-containing food. 
Ivakaftor, ki ga dajemo v obliki monoterapije ali v kombinaciji s tezakaftorjem, je treba dajati skupaj s hrano, ki vsebuje maščobe.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
All patients (N = 39) Results shown as mean (95% CI) change from baseline ivacaftor vs placebo-treated patients: 
Rezultati so prikazani kot povprečna (95 % IZ) sprememba od izhodišča bolnikov, zdravljenih z ivakaftorjem, proti bolnikom, ki so prejemali placebo:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER - 56-TABLET PACK 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE - PAKIRANJE S 56 TABLETAMI
The estimated treatment difference for ivacaftor versus placebo was 2.1 percentage points (95% CI -1.1, 5.4). 
Ocenjena razlika zaradi zdravljenja z ivakaftorjem proti placebu je bila 2,1 odstotne točke (95 % IZ -1,1; 5,4).
When co-administered with strong inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg twice a week (see sections 4.4 and 4.5). 
Kadar zdravilo Kalydeco uporabljamo skupaj z močnimi zaviralci CYP3A, moramo odmerek zdravila Kalydeco zmanjšati na 150 mg dvakrat na teden (glejte poglavji 4.4 in 4.5).
Your child may experience side effects, including those mentioned in section 4 below. 
Če je vaš otrok vzel večji odmerek zdravila Kalydeco, kot bi smel Mogoče bo vaš otrok dobil neželene učinke, vključno s tistimi, ki so omenjeni v poglavju 4 v nadaljevanju.
During the placebo controlled Phase 3 studies (up to 24 weeks) of ivacaftor in a combination regimen with tezacaftor/ivacaftor, the incidence of maximum transaminase (ALT or AST) > 8, > 5, or > 3 x ULN were similar between tezacaftor/ivacaftor in combination with ivacaftor and placebo-treated patients; 0.2%, 1.0%, and 3.4% in tezacaftor/ivacaftor in combination with ivacaftor-treated patients, and 0.4%, 1.0%, and 3.4% in placebo-treated patients. 
Med študijami ivakaftorja v kombinirani shemi s tezakaftorjem/ivakaftorjem 3. faze, kontroliranimi s placebom (do 24 tednov), je bila incidenca najvišje transaminaze (ALT ali AST) > 8, > 5 ali > 3 x ULN podobna pri bolnikih, zdravljenih s tezakaftorjem/ivakaftorjem v kombinaciji z ivakaftorjem, in bolnikih, ki so jim dajali placebo; 0,2 %, 1,0 % in 3,4 % pri bolnikih, zdravljenih s tezakaftorjem/ivakaftorjem v kombinaciji z ivakaftorjem, in 0,4 %, 1,0 % in 3,4 % pri bolnikih, ki so jim dajali placebo.
Insert tab below to close 
PON TOR SRE ČET PET SOB NED
Starting dose: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily. 
Začetni odmerek: ena tableta tezakaftorja 100 mg/ivakaftorja 150 mg enkrat na dan.
Titanium dioxide (E171) Macrogol (PEG 3350) Talc 
Filmska prevleka tablete polivinilalkohol titanov dioksid (E171) makrogol (PEG 3350) smukec indigotin (E132) karnauba vosek
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
* Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days. 
* Nadaljujte odmerjanje s tabletami tezakaftorja 100 mg/ivakaftorja 150 mg ali ivakaftorja 150 mg vsak drugi dan.
No dose adjustment is considered necessary for patients with mild hepatic impairment. 
Menimo, da prilagajanje odmerkov pri bolnikih z blago okvaro jeter ni potrebno.
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET FOR SACHET 
PODATKI NA VMESNI OVOJNINI PRETISNA ZGIBANKA ZA VREČICE
• Tablet core: cellulose microcrystalline, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, sodium laurilsulfate (E487), silica, colloidal anhydrous, and magnesium stearate. 
• Sredica tablete: mikrokristalna celuloza, laktoza monohidrat, hipromeloza acetat sukcinat, premrežen natrijev karmelozat, natrijev lavrilsulfat (E487), koloidni brezvodni silicijev dioksid in magnezijev stearat.
Study 1 and 2: studies in patients with CF with G551D gating mutations The efficacy of Kalydeco has been evaluated in two Phase 3 randomised, double-blind, placebo-controlled, multi-centre studies of clinically stable patients with CF who had the G551D mutation in the CFTR gene on at least 1 allele and had FEV1 ≥ 40% predicted. 
Učinkovitost zdravila Kalydeco so ovrednotili v dveh randomiziranih, dvojno slepih, s placebom kontroliranih multicentričnih študijah 3. faze, opravljenih na klinično stabilnih bolnikih s CF, ki so imeli mutacijo G551D na genu CFTR na vsaj 1 alelu in FEV1 ≥ 40 % napovedane.
Treatment with ivacaftor resulted in a mean absolute change in percent predicted FEV1 through week 24 of 4.5 percentage points in the ivacaftor group versus -0.46 percentage points in the placebo group. 
Zdravljenje z ivakaftorjem je povzročilo povprečno absolutno spremembo v odstotkih napovedanega FEV1 do 24. tedna 4,5 odstotne točke v skupini z ivakaftorjem in -0,46 odstotne točke v skupini s placebom.
Ivacaftor Mean (SD) Cmin, ss (ng/mL) 
Ivakaftor povprečje (SD) Cmin, ss (ng/ml)
• if your child is allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabite zdravila Kalydeco • če je vaš otrok alergičen na ivakaftor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Always give your child this medicine exactly as your child's doctor has told you to. 
Pri dajanju tega zdravila svojemu otroku natančno upoštevajte navodila otrokovega zdravnika.
6 months to less than 12 months (5 kg to < 7 kg) * 
6 mesecev do manj kot 12 mesecev (5 kg do < 7 kg) *
Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with ivacaftor. 
Pri pediatričnih bolnikih, zdravljenih z ivakaftorjem, so poročali o primerih ne-prirojenih motnjav leče brez vpliva na vid.
• Dark urine 
• temen urin.
No dose adjustment is necessary for patients with mild to moderate renal impairment. 
Pri bolnikih z blago do zmerno okvaro ledvic ni potrebno prilagajanje odmerjanja.
When co-administered with moderate inhibitors of CYP3A, the Kalydeco dose is as above recommended, but administered once daily (see sections 4.4 and 4.5). 
Kadar zdravilo Kalydeco uporabljamo skupaj z zmernimi zaviralci CYP3A, naj bo odmerek zdravila Kalydeco tak, kot je priporočen zgoraj, a uporabljen enkrat na dan (glejte poglavji 4.4 in 4.5).
• Nausea or vomiting 
• slabost ali bruhanje,
Kalydeco in a combination regimen with tezacaftor/ivacaftor in adults and adolescents aged 12 years and older 
Zdravilo Kalydeco v kombinirani shemi s tezakaftorjem/ivakaftorjem pri odraslih in mladostnikih,
The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 was 10.6 percentage points (8.6, 12.6) in study 1 and 12.5 percentage points (6.6, 18.3) in study 2. 
Razlika zaradi zdravljenja med ivakaftorjem in placebom za povprečno absolutno spremembo (95 % IZ) v odstotkih napovedanega FEV1 od izhodišča do 24. tedna je bila 10,6 odstotnih točk (8,6; 12,6) v študiji 1 in 12,5 odstotnih točk (6,6; 18,3) v študiji 2.
12 months to less than 24 months (≥ 14 kg to < 25 kg) 
12 mesecev do manj kot 24 mesecev (≥ 14 kg do < 25 kg)
Study 3: study in patients with CF with the F508del mutation in the CFTR gene Study 3 (part A) was a 16-week, 4:1 randomised, double-blind, placebo-controlled, parallel-group Phase 2 study of ivacaftor (150 mg every 12 hours) in 140 patients with CF age 12 years and older who were homozygous for the F508del mutation in the CFTR gene and who had FEV1 ≥ 40% predicted. 
Študija 3 (del A) je bila 16-tedenska, v razmerju 4:1 randomizirana, dvojno slepa, s placebom kontrolirana študija ivakaftorja (150 mg vsakih 12 ur) 2. faze s paralelnimi skupinami pri 140 bolnikih s CF, starih najmanj 12 let, ki so bili homozigotni za mutacijo F508del na genu CFTR in ki so imeli FEV1 ≥ 40% napovedanega.
When co-administered with moderate inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg once daily (see sections 4.4 and 4.5). 
Kadar zdravilo Kalydeco uporabljamo skupaj z zmernimi zaviralci CYP3A, moramo odmerek zdravila Kalydeco zmanjšati na 150 mg enkrat na dan (glejte poglavji 4.4 in 4.5).
Iron oxide black (E172) Propylene glycol (E1520) 
Tiskarsko črnilo šelak črni železov oksid (E172) propilenglikol (E1520) koncentrirana raztopina amoniaka
2- to 5-year-olds (≥ 14 kg to < 25 kg) 
2 do 5 let stari otroci (≥ 14 kg do < 25 kg)
The mean absolute change from baseline through week 24 in percent predicted FEV1 was -2.8 percentage points in the ivacaftor group and 3.5 percentage points in the placebo group. 
Povprečna absolutna sprememba od izhodišča do 24. tedna v odstotkih napovedanega FEV1 je bila -2,8 odstotne točke v skupini z ivakaftorjem in 3,5 odstotne točke v skupini s placebom.
During the 24-week open-label Phase 3 clinical study of ivacaftor in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34). 
Med 24-tedensko odprto klinično študijo z ivakaftorjem 3. faze pri 34 bolnikih, starih 2 leti do manj kot 6 let (študija 7), je bila incidenca bolnikov, pri katerih so se zvišale transaminaze (ALT ali AST) na > 3 x ULN, 14,7 % (5/34).
You may experience side effects, including those mentioned in section 4 below. 
Če ste vzeli večji odmerek zdravila Kalydeco, kot bi smeli Mogoče boste dobili neželene učinke, vključno s tistimi, ki so omenjeni v poglavju 4 v nadaljevanju.
Ivacaftor in a combination regimen with tezacaftor/ivacaftor In patients homozygous for the F508del mutation, the treatment difference between ivacaftor in combination with tezacaftor/ivacaftor and placebo in mean absolute change from baseline in sweat chloride through week 24, was -10.1 mmol/L (95% CI: -11.4, -8.8). 
Pri bolnikih, homozigotnih za mutacijo F508del, je bila razlika zaradi zdravljenja med ivakaftorjem v kombinaciji s tezakaftorjem/ivakaftorjem in placebom, izražena kot povprečna absolutna sprememba kloridov v znoju od izhodišča do vključno 24. tedna, -10,1 mmol/l (95 % IZ: -11,4; -8,8).
Study 5 was a Phase 3, two-part, randomised, double-blind, placebo-controlled, crossover study (part 1) followed by a 16-week open-label extension period (part 2) to evaluate the efficacy and safety of ivacaftor in patients with CF aged 6 years and older who have a G970R or non-G551D gating mutation in the CFTR gene (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D). 
Študija 5 je bila randomizirana, dvojno slepa, s placebom kontrolirana navzkrižna študija 3. faze v dveh delih (prvi del), ki ji je sledilo 16-tedensko odprto obdobje podaljšanja (drugi del) za vrednotenje učinkovitosti in varnosti ivakaftorja pri bolnikih s CF, starih 6 let ali več, ki imajo G970R ali ne-G551D mutacijo spreminjanja prehodnosti na genu CFTR (G178R, S549N, S549R, G551S,
The treatment difference between ivacaftor and placebo for the mean relative change (95% CI) in percent predicted FEV1 from baseline through week 24 was 17.1% (13.9, 20.2) in study 1 and 15.8% (8.4, 23.2) in study 2. 
Razlika zaradi zdravljenja med ivakaftorjem in placebom za povprečno relativno spremembo (95 % IZ) v odstotkih napovedanega FEV1 od izhodišča do 24. tedna je bila 17,1 % (13,9; 20,2) v študiji 1 in 15,8 % (8,4; 23,2) v študiji 2.
No dose adjustment is required when Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is co-administered with ciprofloxacin. 
Kadar dajemo zdravilo Kalydeco (bodisi samo bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) sočasno s ciprofloksacinom, ni potrebno prilagajanje odmerka.
Moderate (Child-Pugh Class B) 
Blage (razred A po Child-Pughovi lestvici)
• Blister card pack containing 28 film-coated tablets 
• pretisna zgibanka, ki vsebuje 28 filmsko obloženih tablet,
Table 4: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1 
Preglednica 4: Učinek ivakaftorja na učinkovitostne spremenljivke v celotni populaciji in po specifičnih mutacijah CFTR
Ivacaftor has not been studied in patients with CF who have undergone organ transplantation. 
Pri bolnikih s CF, pri katerih je bil presajen kak organ, ivakaftorja niso proučevali.
Each film-coated tablet contains 150 mg of ivacaftor. 
Ena filmsko obložena tableta vsebuje 150 mg ivakaftorja.
Very limited data are available for elderly patients treated with ivacaftor (administered as monotherapy or in a combination regimen with tezacaftor/ivacaftor). 
Za starejše bolnike, zdravljene z ivakaftorjem (bodisi v obliki monoterapije bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem), so na voljo zelo omejeni podatki.
Breast mass common 
Telesna masa Odmerek
Table 5: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1 
Preglednica 5: Učinek ivakaftorja na učinkovitostne spremenljivke v celotni populaciji in po specifičnih mutacijah CFTR
During the 24-week open-label Phase 3 clinical study of ivacaftor monotherapy in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34). 
Med 24-tedensko odprto klinično študijo monoterapije z ivakaftorjem 3. faze pri 34 bolnikih, starih 2 leti do manj kot 6 let (študija 7), je bila incidenca bolnikov, pri katerih so se zvišale transaminaze (ALT ali AST) na > 3 x ULN, 14,7 % (5/34).
M1 and M6 are the two major metabolites of ivacaftor in humans. 
Dva poglavitna presnovka ivakaftorja pri ljudeh sta M1 in M6.
The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients 12 to 17 years of age in study 1 was 11.9 percentage points (5.9, 17.9). 
Razlika zaradi zdravljenja med ivakaftorjem in placebom za povprečno absolutno spremembo (95 % IZ) v odstotkih napovedanega FEV1 od izhodišča do 24. tedna pri bolnikih, starih od 12 do 17 let, v študiji 1 je bila 11,9 odstotne točke (5,9; 17,9).
Caution is recommended in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.4 and 5.2). 
Previdnost je priporočljiva pri bolnikih s težkimi okvarami ledvic (očistek kreatinina 30 ml/min ali manj) ali v končnem stadiju bolezni ledvic (glejte poglavji 4.4 in 5.2).
Your doctor may perform some eye examinations prior to and during treatment. 
Zdravnik bo pred zdravljenjem z ivakaftorjem in med njim mogoče opravil nekatere očesne preiskave.
Weight-for-age z-score Length-for-age z-score Weight-for-length z-score 28 
Z-vrednost telesne dolžine za starost Z-vrednost telesne mase za telesno dolžino
The active substance is ivacaftor. 
Učinkovina je ivakaftor.
Table 2: Adverse reactions in ivacaftor-treated patients aged 6 months and older System organ class 
Preglednica 2: Neželeni učinki pri bolnikih, zdravljenih z ivakaftorjem, starih 6 mesecev ali več
The mean absolute change from baseline through week 8 in percent predicted FEV1 (primary efficacy endpoint) was 7.5% in the ivacaftor period and -3.2% in the placebo period. 
Povprečna absolutna sprememba od izhodišča do 8. tedna v odstotkih napovedanega FEV1 (primarni cilj učinkovitosti) je bila 7,5 % v obdobju prejemanja ivakaftorja in -3,2 % v obdobju prejemanja placeba.
• Redness in the throat 
• rdečica v žrelu
• Breast inflammation 
• zatrdlina v dojki
During the 48-week placebo-controlled studies 1 and 2 in patients aged 6 years and older, the incidence of maximum transaminase (ALT or AST) > 8, > 5 or > 3 x ULN was 3.7%, 3.7% and 8.3% in ivacaftor-treated patients and 1.0%, 1.9% and 8.7% in placebo-treated patients, respectively. 
Med študijama 1 in 2, kontroliranima s placebom, ki sta trajali 48 tednov, pri bolnikih, starih 6 let ali več, je bila pojavnost najvišje transaminaze (ALT ali AST) > 8, > 5 oziroma > 3 x ULN, 3,7 %, 3,7 % oziroma 8,3 % pri bolnikih, zdravljenih z ivakaftorjem, in 1,0 %, 1,9 % oziroma 8,7 % pri bolnikih, ki so prejemali placebo.
Cellulose, microcrystalline Lactose monohydrate Hypromellose acetate succinate Croscarmellose sodium Sodium laurilsulfate (E487) Silica, colloidal anhydrous Magnesium stearate 
Sredica tablete mikrokristalna celuloza laktoza monohidrat hipromeloza acetat sukcinat premreženi natrijev karmelozat natrijev lavrilsulfat (E487) koloidni brezvodni silicijev dioksid magnezijev stearat
Kalydeco monotherapy 
Monoterapija z zdravilom Kalydeco
Kalydeco in a combination regimen with tezacaftor/ivacaftor The efficacy and safety of Kalydeco in a combination regimen with tezacaftor/ivacaftor in patients with CF was assessed in two clinical studies; a 24 week, randomized, double-blind, placebo-controlled study with 504 patients aged 12 years and older who were homozygous for the F508del mutation; and a randomized, double-blind, placebo-controlled and ivacaftor controlled, 2 period, 3 treatment, 8-week crossover study with 244 patients aged 12 years and older who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity. 
Učinkovitost in varnost zdravila Kalydeco v kombinirani shemi s tezakaftorjem/ivakaftorjem pri bolnikih s CF so ocenili v dveh kliničnih študijah, 24-tedenski randomizirani, dvojno slepi študiji, kontrolirani s placebom, pri 504 bolnikih, starih 12 let ali več, ki so bili homozigotni za mutacijo
Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating ivacaftor treatment. 
Pri pediatričnih bolnikih, ki začenjajo zdravljenje z ivakaftorjem, priporočajo izhodiščne in kontrolne oftalmološke preiskave.
No dose adjustment is required when Kalydeco is co-administered with ciprofloxacin. 
Kadar dajemo zdravilo Kalydeco sočasno s ciprofloksacinom, ni potrebno prilagajanje odmerka.
Co-administration with fluconazole, a moderate inhibitor of CYP3A, increased ivacaftor exposure by 3-fold and increased M1 to a lesser extent than ivacaftor. 
Sočasna uporaba s flukonazolom, ki je zmeren zaviralec CYP3A, je zvečala izpostavljenost ivakaftorju za 3-krat in zvečala izpostavljenost M1 v manjši meri kot izpostavljenost ivakaftorju.
Give Kalydeco to your child for as long as your child's doctor recommends. 
Če ste otroku prenehali dajati zdravilo Kalydeco Otroku dajajte zdravilo Kalydeco, dokler to priporoča otrokov zdravnik.
The mean absolute change from baseline through week 24 in percent predicted FEV1 (primary efficacy endpoint) was 2.57 percentage points in the ivacaftor group and 0.46 percentage points in the placebo group. 
Povprečna absolutna sprememba od izhodišča do 24. tedna v odstotkih napovedanega FEV1 (primarni cilj študije glede učinkovitosti) je bila 2,57 odstotne točke v skupini z ivakaftorjem in 0,46 odstotne točke v skupini s placebom.
A reduction of the Kalydeco dose is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin (see sections 4.2 and 4.4). 
Za bolnike, ki sočasno jemljejo zmerne zaviralce CYP3A, kakršna sta flukonazol in eritromicin, priporočajo zmanjšanje odmerka zdravila Kalydeco (glejte poglavji 4.2 in 4.4).
Baseline 
OVOJNINAH
Important information about the contents of Kalydeco 
Pomembne informacije o vsebini zdravila Kalydeco Zdravilo Kalydeco vsebuje laktozo.
• Increased liver enzymes in the blood have been seen in some people receiving Kalydeco (alone or in combination with tezacaftor/ivacaftor). 
• Pri nekaterih ljudeh, ki jemljejo zdravilo Kalydeco (bodisi samo bodisi v kombinaciji s tezakaftorjem/ivakaftorjem), so opazili zvišane jetrne encime v krvi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER CARD - 28-TABLET PACK 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNO ZGIBANKO - PAKIRANJE Z 28 TABLETAMI
6- to 11-year-olds † (≥ 14 kg to < 25 kg) 
6 do 11 let stari otroci (≥ 14 kg do < 25 kg)
Weight-for-age z-score at week 48e 
Povprečna sprememba od izhodišča v z-vrednostih telesna masa za starost zvrednost v tednu 48e
The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients with baseline predicted FEV1 greater than 90% in study 2 was 6.9 percentage points (-3.8, 17.6). 
Razlika zaradi zdravljenja med ivakaftorjem in placebom za povprečno absolutno spremembo (95 % IZ) v odstotkih napovedanega FEV1 od izhodišča do 24. tedna pri bolnikih, ki so imeli v izhodišču napovedani FEV1 večji od 90 % v študiji 2, je bila 6,9 odstotne točke (-3,8; 17,6).
The use of Kalydeco monotherapy or in combination with tezacaftor/ivacaftor in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see Table 2 in section 4.2 and section 4.4). 
Uporaba monoterapije z zdravilom Kalydeco ali v kombinaciji s tezakaftorjem/ivakaftorjem pri bolnikih s težko okvaro jeter zato ni priporočljiva, razen če pričakovana korist odtehta tveganja (glejte preglednico 2 v poglavju 4.2 in poglavje 4.4).
6- to 11-year-olds † (≥ 25 kg) 
6 do 11 let stari otroci (≥ 25 kg)
• Talk to your doctor if you have liver problems, or have previously had them. 
• Posvetujte se z zdravnikom, če imate ali ste kdaj prej imeli težave z jetri.
Concomitant use of CYP3A inhibitors 
Sočasna uporaba zaviralcev CYP3A