FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: • Nausea or vomiting
Slovenian: • slabost ali bruhanje,
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor in adults and adolescents aged 12 years and older
Slovenian: Zdravilo Kalydeco v kombinirani shemi s tezakaftorjem/ivakaftorjem pri odraslih in mladostnikih,
English: 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.
Slovenian: 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.
English: 12 months to less than 24 months (≥ 14 kg to < 25 kg)
Slovenian: 12 mesecev do manj kot 24 mesecev (≥ 14 kg do < 25 kg)
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Iron oxide black (E172) Propylene glycol (E1520)
Slovenian: Tiskarsko črnilo šelak črni železov oksid (E172) propilenglikol (E1520) koncentrirana raztopina amoniaka
English: 2- to 5-year-olds (≥ 14 kg to < 25 kg)
Slovenian: 2 do 5 let stari otroci (≥ 14 kg do < 25 kg)
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: You may experience side effects, including those mentioned in section 4 below.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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,
English: 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.
Slovenian: 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.
English: No dose adjustment is required when Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is co-administered with ciprofloxacin.
Slovenian: Kadar dajemo zdravilo Kalydeco (bodisi samo bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem) sočasno s ciprofloksacinom, ni potrebno prilagajanje odmerka.
English: Moderate (Child-Pugh Class B)
Slovenian: Blage (razred A po Child-Pughovi lestvici)
English: • Blister card pack containing 28 film-coated tablets
Slovenian: • pretisna zgibanka, ki vsebuje 28 filmsko obloženih tablet,
English: Table 4: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1
Slovenian: Preglednica 4: Učinek ivakaftorja na učinkovitostne spremenljivke v celotni populaciji in po specifičnih mutacijah CFTR
English: Ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Slovenian: Pri bolnikih s CF, pri katerih je bil presajen kak organ, ivakaftorja niso proučevali.
English: Each film-coated tablet contains 150 mg of ivacaftor.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg ivakaftorja.
English: Very limited data are available for elderly patients treated with ivacaftor (administered as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Slovenian: Za starejše bolnike, zdravljene z ivakaftorjem (bodisi v obliki monoterapije bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem), so na voljo zelo omejeni podatki.
English: Breast mass common
Slovenian: Telesna masa Odmerek
English: Table 5: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1
Slovenian: Preglednica 5: Učinek ivakaftorja na učinkovitostne spremenljivke v celotni populaciji in po specifičnih mutacijah CFTR
English: 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).
Slovenian: 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).
English: M1 and M6 are the two major metabolites of ivacaftor in humans.
Slovenian: Dva poglavitna presnovka ivakaftorja pri ljudeh sta M1 in M6.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Your doctor may perform some eye examinations prior to and during treatment.
Slovenian: Zdravnik bo pred zdravljenjem z ivakaftorjem in med njim mogoče opravil nekatere očesne preiskave.
English: Weight-for-age z-score Length-for-age z-score Weight-for-length z-score 28
Slovenian: Z-vrednost telesne dolžine za starost Z-vrednost telesne mase za telesno dolžino
English: The active substance is ivacaftor.
Slovenian: Učinkovina je ivakaftor.
English: Table 2: Adverse reactions in ivacaftor-treated patients aged 6 months and older System organ class
Slovenian: Preglednica 2: Neželeni učinki pri bolnikih, zdravljenih z ivakaftorjem, starih 6 mesecev ali več
English: 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.
Slovenian: 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.
English: • Redness in the throat
Slovenian: • rdečica v žrelu
English: • Breast inflammation
Slovenian: • zatrdlina v dojki
English: G1244E (5) G1349D (2) G178R (5) G551S (2) G970R# (4) S1251N (8) S1255P (2) S549N (6) S549R (4)
Slovenian: S1251N (8) S1255P (2) S549N (6) S549R (4)
English: 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.
Slovenian: 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.
English: Cellulose, microcrystalline Lactose monohydrate Hypromellose acetate succinate Croscarmellose sodium Sodium laurilsulfate (E487) Silica, colloidal anhydrous Magnesium stearate
Slovenian: Sredica tablete mikrokristalna celuloza laktoza monohidrat hipromeloza acetat sukcinat premreženi natrijev karmelozat natrijev lavrilsulfat (E487) koloidni brezvodni silicijev dioksid magnezijev stearat
English: Kalydeco monotherapy
Slovenian: Monoterapija z zdravilom Kalydeco
English: 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.
Slovenian: 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
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating ivacaftor treatment.
Slovenian: Pri pediatričnih bolnikih, ki začenjajo zdravljenje z ivakaftorjem, priporočajo izhodiščne in kontrolne oftalmološke preiskave.
English: No dose adjustment is required when Kalydeco is co-administered with ciprofloxacin.
Slovenian: Kadar dajemo zdravilo Kalydeco sočasno s ciprofloksacinom, ni potrebno prilagajanje odmerka.
English: Co-administration with fluconazole, a moderate inhibitor of CYP3A, increased ivacaftor exposure by 3-fold and increased M1 to a lesser extent than ivacaftor.
Slovenian: 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.
English: Give Kalydeco to your child for as long as your child's doctor recommends.
Slovenian: Če ste otroku prenehali dajati zdravilo Kalydeco Otroku dajajte zdravilo Kalydeco, dokler to priporoča otrokov zdravnik.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Baseline
Slovenian: OVOJNINAH
English: Important information about the contents of Kalydeco
Slovenian: Pomembne informacije o vsebini zdravila Kalydeco Zdravilo Kalydeco vsebuje laktozo.
English: • Increased liver enzymes in the blood have been seen in some people receiving Kalydeco (alone or in combination with tezacaftor/ivacaftor).
Slovenian: • Pri nekaterih ljudeh, ki jemljejo zdravilo Kalydeco (bodisi samo bodisi v kombinaciji s tezakaftorjem/ivakaftorjem), so opazili zvišane jetrne encime v krvi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER CARD - 28-TABLET PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNO ZGIBANKO - PAKIRANJE Z 28 TABLETAMI
English: 6- to 11-year-olds † (≥ 14 kg to < 25 kg)
Slovenian: 6 do 11 let stari otroci (≥ 14 kg do < 25 kg)
English: Weight-for-age z-score at week 48e
Slovenian: Povprečna sprememba od izhodišča v z-vrednostih telesna masa za starost zvrednost v tednu 48e
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 6- to 11-year-olds † (≥ 25 kg)
Slovenian: 6 do 11 let stari otroci (≥ 25 kg)
English: • Talk to your doctor if you have liver problems, or have previously had them.
Slovenian: • Posvetujte se z zdravnikom, če imate ali ste kdaj prej imeli težave z jetri.
English: Concomitant use of CYP3A inhibitors
Slovenian: Sočasna uporaba zaviralcev CYP3A
English: There was negligible urinary excretion of ivacaftor as unchanged parent.
Slovenian: Ivakaftor kot nespremenjena izhodna snov se je izločal v urinu v zanemarljivih količinah.
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (see section 4.2).
Slovenian: Med zdravljenjem z zdravilom Kalydeco se je treba izogibati hrani in pijači, ki vsebujeta grenivke ali grenke pomaranče (glejte poglavje 4.2).
English: During the 48-week placebo-controlled studies 1 and 2 of ivacaftor monotherapy 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.
Slovenian: Med študijama 1 in 2 monoterapije z ivakaftorjem, kontroliranima s placebom, ki sta trajali 48 tednov, pri bolnikih, starih 6 let ali več, je bila pogostnost 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.
English: Caution is recommended for patients with severe renal impairment or end-stage renal disease (see section 5.2).
Slovenian: Pri bolnikih s težko okvaro ledvic ali boleznijo ledvic v končnem stadiju je priporočljiva previdnost (glejte poglavje 5.2).
English: • Rash
Slovenian: • driska
English: At the follow-up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -5.9% (9.4%).
Slovenian: Pri kontrolnem pregledu 4 tedne po koncu odmerjanja z ivakaftorjem je bila povprečna (SD) absolutna sprememba v odstotkih napovedanega FEV1 iz 16. tedna drugega dela -5,9 % (9,4 %).
English: Kalydeco 75 mg granules in sachet are white to off-white granules.
Slovenian: Kalydeco 75 mg zrnca v vrečici so bela do belkasta zrnca.
English: At the follow up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -7.4% (5.5%).
Slovenian: Pri kontrolnem pregledu 4 tedne po koncu odmerjanja ivakaftorja je bila povprečna (SD) absolutna sprememba napovedanega FEV1 v odstotkih od 16. tedna drugega dela -7,4 % (5,5 %).
English: Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Slovenian: Na podlagi teh rezultatov pri bolnikih z zmerno okvaro jeter priporočajo spremenjeno shemo monoterapije z zdravilom Kalydeco (glejte preglednico 2 v poglavju 4.2).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHETS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: The mean absolute change from baseline through week 16 in percent predicted FEV1 (primary efficacy endpoint) was 1.5 percentage points in the ivacaftor group and -0.2 percentage points in the placebo group.
Slovenian: Povprečna absolutna sprememba od izhodišča do 16. tedna v odstotkih napovedanega FEV1 (cilj študije glede učinkovitosti) je bila 1,5 odstotne točke v skupini z ivakaftorjem in -0,2 odstotne točke v skupini s placebom.
English: Use of ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Slovenian: Uporaba ivakaftorja, bodisi samega bodisi v kombinirani shemi s tezakaftorjem/ivakaftorjem, pri bolnikih s težkimi okvarami jeter ni priporočljiva, razen če pričakujemo, da bodo koristi odtehtale tveganja (glejte poglavji 4.2 in 5.2).
English: Mean absolute change from baseline in body weight (kg)
Slovenian: Povprečna absolutna sprememba telesne mase (kg) od izhodišča
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanja transaminaz zelo pogosti
English: Based on these results, a modified regimen for Kalydeco in a combination regimen with tezacaftor/ivacaftor is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Slovenian: Na podlagi teh rezultatov pri bolnikih z zmerno okvaro jeter priporočajo spremenjeno shemo zdravila Kalydeco v kombinirani shemi s tezakaftorjem/ivakaftorjem (glejte preglednico 2 v poglavju 4.2).
English: The use of Kalydeco in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see section 4.2 and section 4.4).
Slovenian: Uporaba zdravila Kalydeco pri bolnikih s težko okvaro jeter zato ni priporočljiva, razen če pričakovana korist odtehta tveganja (glejte poglavji 4.2 in 4.4).
English: Caution is recommended when administering ivacaftor, either as monotherapy or in combination with tezacaftor, to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.2 and 4.4).
Slovenian: Priporočljiva je previdnost, kadar dajemo ivakaftor, bodisi kot monoterapijo bodisi v kombinaciji s tezakaftorjem, bolnikom s težko okvaro ledvic (očistek kreatinina največ 30 ml/min) ali z boleznijo ledvic v končnem stadiju (glejte poglavji 4.2 in 4.4).
English: Kalydeco can make you dizzy.
Slovenian: Zdravilo Kalydeco lahko povzroči omotico.
English: After oral administration of ivacaftor150 mg every 12 hours for 7 days in healthy volunteers in a fed state, the mean (± SD) apparent volume of distribution was 353 (122) L.
Slovenian: Po peroralni aplikaciji 150 mg ivakaftorja vsakih 12 ur 7 dni dolgo zdravim prostovoljcem po obroku hrane je bilo povprečje (± SD) navideznega porazdelitvenega volumna 353 (122) l.
English: Tezacaftor 100 mg/ ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Slovenian: Jutranji odmerek tableta tezakaftorja 100 mg/ ivakaftorja 150 mg tableta ivakaftorja 150 mg
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj zelo pogosti
English: Kalydeco 50 mg granules in sachet are white to off-white granules.
Slovenian: Kalydeco 50 mg zrnca v vrečici so bela do belkasta zrnca.
English: Table 5: Effect of ivacaftor on percent predicted FEV1 in study 4 Original study and treatment group
Slovenian: Preglednica 5: Vpliv ivakaftorja na spremembe v odstotkih napovedanega FEV1 v študiji 4
English: Table 6: Effect of ivacaftor on percent predicted FEV1 in study 4 Original study and treatment group
Slovenian: Preglednica 6: Vpliv ivakaftorja na spremembe v odstotkih napovedanega FEV1 v študiji 4
English: Contact your doctor straight away if you get any of these.
Slovenian: Če dobite katerega od teh, se takoj obrnite na svojega zdravnika.
English: • Redness inside the ear
Slovenian: • rdečica v ušesu
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 7 tablet
English: Kalydeco 25 mg granules in sachet are white to off-white granules.
Slovenian: Kalydeco 25 mg zrnca v vrečici so bela do belkasta zrnca.
English: • If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: • Če opazite pri otroku kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: After oral administration of ivacaftor 150 mg every 12 hours for 7 days in healthy volunteers in a fed state, the mean (± SD) apparent volume of distribution was 353 (122) L.
Slovenian: Po peroralni aplikaciji ivakaftorja v odmerku 150 mg vsakih 12 ur 7 dni dolgo zdravim prostovoljcem po obroku hrane je bilo povprečje (± SD) navideznega porazdelitvenega volumna 353 (122) l.