FrancophonIA/ELRC3.0 huggingface dataset:
English: P value
Slovenian: vrednost P
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Pogostost neželenih učinkov je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: * Treatment occurred during blinded, controlled, 48-week Phase 3 study.
Slovenian: * Zdravljenje med slepo, kontrolirano 48-tedensko študijo 3. faze.
English: Each sachet is for single use only.
Slovenian: Vsaka vrečica je samo za enkratno uporabo.
English: Relative risk of pulmonary exacerbation
Slovenian: Relativno tveganje pljučne eksacerbacije
English: Absolute change at week 24
Slovenian: Absolutna sprememba v 24. tednu
English: Patients continued on their prescribed standard-of-care CF therapies.
Slovenian: Bolniki so se še naprej zdravili s svojimi predpisanimi standardnimi terapijami CF.
English: Tertiary endpoints included efficacy measures such as Faecal Elastase-1 and growth parameters.
Slovenian: Terciarni cilji so vključevali merila učinkovitosti, na primer fekalno elastazo-1 in parametre rasti.
English: Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs.
Slovenian: Obroki ali prigrizki, ki vsebujejo maščobe, vključujejo tiste, ki so pripravljeni z maslom ali olji, in tiste, ki vsebujejo jajca.
English: †† n = 3 for the analysis of absolute change in sweat chloride.
Slovenian: †† n = 3 za analizo absolutne spremembe kloridov v znoju.
English: If you feel dizzy, do not drive, cycle or use machines.
Slovenian: Če ste omotični, ne vozite, ne kolesarite in ne uporabljajte strojev.
English: An open-label, rollover, 96 week study is on-going to evaluate the long-term safety and efficacy of the combination regimen in both patient populations.
Slovenian: Odprta obnovitvena 96-tedenska študija za ocenjevanje dolgoročne varnosti in učinkovitosti kombinirane sheme v obeh populacijah bolnikov je v teku.
English: Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Slovenian: Druga zdravila, katerih izpostavljenost se lahko zveča, vključujejo glimepirid in glipizid; ta zdravila je treba uporabljati previdno.
English: A total of 36 patients continued into part 2 (18 per treatment sequence).
Slovenian: Vsega skupaj 36 bolnikov je nadaljevalo v drugi del (18 na posamezno zaporedje zdravljenja).
English: At the start of the study, patients in the placebo group used some medicinal products at a higher frequency than the ivacaftor group.
Slovenian: V začetku študije so bolniki v skupini s placebom uporabljali nekatera zdravila pogosteje kot v skupini z ivakaftorjem.
English: * Statistical testing was not performed due to small numbers for individual mutations.
Slovenian: * Zaradi majhnega števila posameznih mutacij statistično testiranje ni bilo opravljeno.
English: Study 1
Slovenian: Študija 1
English: Digoxin and other P-gp substrates
Slovenian: Digoksin in drugi substrati P-gp
English: Kalydeco should only be prescribed by physicians with experience in the treatment of cystic fibrosis.
Slovenian: Zdravilo Kalydeco naj predpisujejo le zdravniki, ki imajo izkušnje z zdravljenjem cistične fibroze.
English: In both studies, improvements in FEV1 were rapid in onset (day 15) and durable through 48 weeks.
Slovenian: V obeh študijah so izboljšanja FEV1 nastopila hitro (15. dne) in so trajala vseh 48 tednov.
English: Exposures in 6- to 11-year-olds are predictions based on simulations from the population PK model using data obtained for this age group.
Slovenian: Izpostavljenosti pri 6 do 11 let starih otrocih so napovedi na podlagi simulacij iz populacijskega FK modela z uporabo podatkov, dobljenih pri tej starostni skupini.
English: Adults (≥ 18 years old)
Slovenian: Odrasli (stari ≥ 18 let)
English: Open
Slovenian: Odprite.
English: Ensure that the mixture is completely and immediately consumed.
Slovenian: Zagotovite, da bo otrok mešanico zaužil v celoti in takoj.
English: Patients in study 7 were aged 2 to less than 6 years (mean age 3 years).
Slovenian: Bolniki v študiji 7 so bili stari 2 leti do manj kot 6 let (povprečna starost 3 leta).
English: Patients should be instructed to swallow the tablets whole.
Slovenian: Bolnikom je treba naročiti, naj tablete pogoltnejo cele.
English: Your child's doctor will determine the correct dose for your child.
Slovenian: Otrokov zdravnik bo določil pravilen odmerek za vašega otroka.
English: • Moderate liver problems: the dose may be reduced to one half of the indicated dose in the table above, that is one sachet once daily.
Slovenian: • Zmerne težave z jetri: odmerek lahko zmanjšamo na polovico odmerka, ki je naveden v zgornji preglednici, to je na eno vrečico enkrat na dan.
English: In vitro studies showed that ivacaftor is not a substrate for OATP1B1 or OATP1B3.
Slovenian: Študije in vitro so pokazale, da ivakaftor ni substrat za OATP1B1 ali OATP1B3.
English: Therefore, liver function tests are recommended for all patients prior to initiating ivacaftor, every 3 months during the first year of treatment and annually thereafter.
Slovenian: Zato je priporočljivo, da vsi bolniki opravijo teste funkcije jeter, preden uvedemo ivakaftor, vsake 3 mesece prvo leto zdravljenja, nato pa enkrat na leto.
English: The major metabolites M1 and M6 accounted for approximately 65% of the total dose eliminated with 22% as M1 and 43% as M6.
Slovenian: Poglavitna presnovka M1 in M6 sta predstavljala približno 65 % celotnega odstranjenega odmerka, od tega 22 % kot M1 in 43 % kot M6.
English: The phase of the poly-T variant identified with the R117H mutation should be determined in accordance with local clinical recommendations.
Slovenian: Fazo variante poli-T, identificirano z mutacijo R117H, je treba določiti v skladu z lokalnimi kliničnimi priporočili.
English: • Yellowing of the skin or the white part of the eyes
Slovenian: • porumenelost kože ali očesne beločnice,
English: See Kalydeco tablets SmPC for further details.
Slovenian: Glejte SmPC za tablete Kalydeco za dodatne podrobnosti
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • Pain or discomfort in the upper right stomach (abdominal) area
Slovenian: • bolečina ali nelagodje v zgornjem desnem predelu trebuha,
English: Effect on liver function tests
Slovenian: Vpliv na teste funkcije jeter
English: No statistical analysis was conducted for subjects 12 to 17 years of age because only 2 patients were enrolled in this study.
Slovenian: Pri preiskovancih, starih 12 do 17 let, niso opravili statistične analize, ker sta bila v to študijo vključena samo 2 bolnika.
English: The use of inhaled hypertonic sodium chloride was not permitted.
Slovenian: Uporaba inhaliranega hipertoničnega natrijevega klorida ni bila dovoljena.
English: In study 5, four patients with the G970R mutation were included.
Slovenian: V študijo 5 so bili vključeni štirje bolniki z mutacijo G970R.
English: The effect of the potentially reduced activity of CYP3A4 in patients carrying the CYP3A4*22 variant on ivacaftor exposure is not known.
Slovenian: Učinek potencialno zmanjšane aktivnosti CYP3A4 pri bolnikih z različico CYP3A4*22 ob izpostavljanju ivakaftorju ni znan.
English: • Hold sachet of granules with cut line on top.
Slovenian: • Primite vrečico z zrnci s prekinjeno črto na vrhu.
English: The safety profile is generally consistent among paediatric patients aged 6 months and older and adult patients.
Slovenian: Varnostni profil se na splošno ujema med pediatričnimi bolniki, starimi 6 mesecev ali več, in odraslimi bolniki.
English: Infants aged at least 6 months, toddlers, children, adolescents and adults should be dosed according to Table 1.
Slovenian: Dojenčki, stari najmanj 6 mesecev, malčki, otroci, mladostniki in odrasli morajo prejeti odmerek glede na priporočila v preglednici 1.
English: The exact mechanism leading ivacaftor to potentiate the gating activity of normal and some mutant CFTR forms in this system has not been completely elucidated.
Slovenian: Natančni mehanizem, s katerim ivakaftor podaljša aktivnost odpiranja kanalčkov normalnih in nekaterih mutantnih oblik CFTR v tem sistemu, še ni popolnoma pojasnjen.
English: Tell your doctor right away if you have any of these symptoms, which may be a sign of liver problems:
Slovenian: Takoj povejte svojemu zdravniku, če imate katerega od teh simptomov, ki utegnejo biti znak težav z jetri:
English: Ciprofloxacin
Slovenian: Ciprofloksacin
English: Kalydeco is available in the following pack sizes:
Slovenian: Zdravilo Kalydeco je na voljo v naslednjih velikostih pakiranj:
English: • Ringing in the ears
Slovenian: • zvenenje v ušesih
English: You must keep using all other medicines you use, unless your doctor tells you to stop using any.
Slovenian: Še naprej morate jemati vsa druga zdravila, ki jih jemljete, razen če vam zdravnik naroči, da prenehajte jemati katero od zdravil.
English: Serious side effects include stomach (abdominal) ache and increased liver enzymes in the blood.
Slovenian: Med resnimi neželenimi učinki so bolečine v želodcu (trebuhu) in zvišani jetrni encimi v krvi.
English: Giving Kalydeco to your child:
Slovenian: Dajanje zdravila Kalydeco otroku:
English: Co. Armagh BT63 5UA United Kingdom
Slovenian: Co. Armagh BT63 5UA Velika Britanija
English: What Kalydeco is and what it is used for 2.
Slovenian: Kaj je zdravilo Kalydeco in za kaj ga uporabljamo 2.
English: The other ingredients are:
Slovenian: • Druge sestavine zdravila so:
English: • Avocados, hummus, soy-based products (tofu)
Slovenian: • avokado, humus, izdelki iz soje (tofu)
English: An appropriate dose for children under 6 years of age and weighing less than 25 kg cannot be achieved with Kalydeco tablets.
Slovenian: Primernega odmerka za otroke, mlajše od 6 let, in s telesno maso, manjšo od 25 kg, s tabletami zdravila Kalydeco ne moremo doseči.
English: Pharmacotherapeutic group: Other respiratory system products, ATC code: R07AX02
Slovenian: Farmakoterapevtska skupina: Druga zdravila za zdravljenje bolezni dihal, oznaka ATC: R07AX02
English: Dosing intervals should be modified according to clinical response and tolerability.
Slovenian: Presledke med odmerki je treba spreminjati glede na klinični odziv in prenašanje.
English: The tablets should not be chewed, crushed, or broken before swallowing.
Slovenian: Bolniki tablet ne smejo žvečiti, zdrobiti ali raztopiti, preden jih pogoltnejo.
English: Patients grouped under mutation types (n)
Slovenian: Bolniki, razporejeni po vrstah mutacij (n)
English: The confirmed R117H poly-T variant was 5T in 38 patients and 7T in 16 patients.
Slovenian: Potrjena varianta poli-T R117H je bila 5T pri 38 bolnikih in 7T pri 16 bolnikih.
English: 12- to 17-year-olds
Slovenian: 12 do 17 let stari otroci
English: The median (range) tmax is approximately 4.0 (3.0; 6.0) hours in the fed state.
Slovenian: Mediana (razpon) tmax je približno 4,0 (3,0; 6,0) ur pri polnem želodcu.
English: Kalydeco with food and drink
Slovenian: Zdravilo Kalydeco skupaj s hrano in pijačo
English: The magnitude of increase in exposure in these patients is unknown but is expected to be higher than that observed in patients with moderate hepatic impairment.
Slovenian: Ni znano, kako veliko je zvečanje izpostavljenosti pri teh bolnikih, vendar pričakujemo, da je večje kot pri bolnikih z zmerno okvaro jeter.
English: Other fat-containing foods are:
Slovenian: Druge vrste hrane, ki vsebujejo maščobe, so:
English: One patient (0.2%) on therapy and 2 patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Slovenian: En bolnik (0,2 %) na terapiji in 2 bolnika (0,4 %) na placebo sta se trajno prenehala zdraviti zaradi zvišanih transaminaz.
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Slovenian: Približno 99 % ivakaftorja se veže na plazemske beljakovine, predvsem na alfa 1-kisli glikoprotein in albumin.
English: The pharmacokinetics of ivacaftor are generally linear with respect to time or dose ranging from 25 mg to 250 mg.
Slovenian: Farmakokinetika ivakaftorja je na splošno linearna, kar se tiče časa ali odmerka med 25 mg in 250 mg.
English: • Kalydeco is not recommended for patients who have undergone an organ transplant.
Slovenian: • Zdravila Kalydeco ne priporočajo bolnikom, ki so jim presadili kak organ.
English: Otherwise, wait until your next scheduled dose as you normally would.
Slovenian: Drugače počakajte na naslednji načrtovani odmerek, kot bi tudi normalno.
English: Clinical studies of ivacaftor monotherapy did not include sufficient numbers of patients age 65 years and older to determine whether pharmacokinetic parameters are similar or not to those in younger adults.
Slovenian: V klinične študije monoterapije z ivakaftorjem ni bilo vključenih dovolj bolnikov, starih 65 let ali več, da bi ugotovili, ali so farmakokinetični parametri podobni tistim pri mlajših odraslih ali ne.
English: Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: If possible, have your medicine and this leaflet with you.
Slovenian: Če je le mogoče, imejte zdravilo in to navodilo s seboj.
English: Six patients with initial levels below 200 µg/g achieved, at week 24, a level of ≥ 200 µg/g.
Slovenian: Šest bolnikov z začetnimi vrednostmi pod 200 µg/g je imelo v 24. tednu vrednost ≥ 200 µg/g.
English: Due to its high intrinsic permeability and low likelihood of being excreted intact, co-administration of BCRP inhibitors is not expected to alter exposure of ivacaftor and M1-IVA, while any potential changes in M6-IVA exposures are not expected to be clinically relevant.
Slovenian: Zaradi velike intrinzične permeabilnosti in majhne verjetnosti, da se bo izločil nespremenjen, ne pričakujemo, da bo sočasno dajanje zaviralcev BCRP spremenilo izpostavljenost ivakatorju in M1-IVA, in ne pričakujemo, da bodo možne spremembe izpostavljenosti M6-IVA klinično pomembne.
English: Vertex Pharmaceuticals (Ireland) Limited
Slovenian: DRUGI PODATKI Vertex Pharmaceuticals (Ireland) Limited
English: The mean overall post-baseline value was 76.0% and 83.7%, respectively.
Slovenian: Povprečna celotna vrednost po izhodišču je bila 76,0 % oziroma 83,7 %.
English: Use within one hour after mixing, just before or after a fat-containing meal or snack.
Slovenian: Porabite v eni uri po pripravi mešanice tik pred obrokom ali prigrizkom, ki vsebuje maščobe, ali tik po njem.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ivacaftor in pregnant women.
Slovenian: Podatkov o uporabi ivakaftorja pri nosečnicah ni oziroma so omejeni (manj kot 300 izidov nosečnosti).
English: Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Slovenian: Pri tem bo zdravnik pretehtal prednosti dojenja za otroka in prednosti zdravljenja za vas.
English: d Hazard ratio for time to first pulmonary exacerbation e In subjects under 20 years of age (CDC growth charts)
Slovenian: d razmerje tveganja za čas do prve pljučne eksacerbacije e pri osebah, mlajših od 20 let (referenčne vrednosti rasti CDC)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kalydeco in one or more subsets of the paediatric population in cystic fibrosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Kalydeco za eno ali več podskupin pediatrične populacije pri cistični fibrozi (glejte poglavje 4.2 za informacije o uporabi pri otrocih).
English: Your doctor may decide to adjust your dose or that you need extra check-ups.
Slovenian: Zdravnik se bo mogoče odločil, da vam bo prilagodil odmerek ali da potrebujete dodatne kontrolne preglede.
English: If possible, have your child's medicine and this leaflet with you.
Slovenian: Če je le mogoče, imejte otrokovo zdravilo in to navodilo s seboj.
English: In particular, tell your doctor if you are taking any of the medicines listed below.
Slovenian: Še posebno povejte zdravniku, ali jemljete katero od spodaj navedenih zdravil.
English: Available pharmacokinetic data in animals have shown excretion of ivacaftor into the milk of lactating female rats.
Slovenian: Farmakokinetični podatki na živalih, ki so na voljo, kažejo, da se ivakaftor izloča v mleko podganjih samic.
English: The primary endpoint of safety was evaluated through week 24 (see section 4.8).
Slovenian: Primarno končno stanje varnosti so ocenjevali v teku 24 tednov (glejte poglavje 4.8).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kalydeco therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Kalydeco, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za žensko.
English: In three of four patients the change in the sweat chloride test was < 5 mmol/L and this group did not demonstrate a clinically relevant improvement in FEV1 after 8 weeks of treatment.
Slovenian: Pri treh od štirih bolnikov se je test kloridov v znoju spremenil za < 5 mmol/l in ta skupina ni pokazala klinično pomembnega izboljšanja FEV1 po 8 tednih zdravljenja.
English: Food or liquid should be at room temperature or below.
Slovenian: Hrana ali tekočina mora biti segreta na sobno temperaturo ali manj.
English: Therefore, no dose adjustment of oral contraceptives is necessary.
Slovenian: Zato prilagajanje odmerka peroralnih kontraceptivov ni potrebno.
English: Race had no clinically meaningful effect on the PK of ivacaftor in white (n = 379) and non-white (n = 29) patients based on a population PK analysis.
Slovenian: Rasa nima klinično pomembnega učinka na FK ivakaftorja pri belcih (n = 379) in bolnikih drugih ras (n = 29) na podlagi populacijske FK analize.
English: The G970R mutation causes a splicing defect resulting in little-to-no CFTR protein at the cell surface which may explain the results observed in subjects with this mutation in study 5 (see Pharmacodynamic effects and Clinical efficacy data).
Slovenian: Mutacija G970R povzroči cepitveni defekt, ta pa povzroči, da je na celični površini malo ali nič beljakovine CFTR, kar lahko pojasni rezultate, ki so bili opaženi pri bolnikih s to mutacijo v študiji 5 (glejte podatke v poglavjih Farmakodinamični učinki in Klinična učinkovitost).
English: Ivacaftor had an effect on fertility in rats (see section 5.3).
Slovenian: Ivakaftor je vplival na plodnost pri podganah (glejte poglavje 5.3).
English: Following oral administration in healthy volunteers, the majority of ivacaftor (87.8%) was eliminated in the faeces after metabolic conversion.
Slovenian: Po peroralni uporabi pri zdravih prostovoljcih se je večina ivakaftorja (87,8 %) po presnovni pretvorbi odstranila iz telesa z blatom.
English: Otherwise, wait until your child's next scheduled dose as you normally would.
Slovenian: Drugače počakajte na naslednji načrtovani otrokov odmerek, kot bi tudi normalno.
English: Ivacaftor decreased survival and lactation indices and caused a reduction in pup body weights.
Slovenian: Ivakaftor je zmanjšal indeksa preživetja in laktacije in povzročil zmanjšanje telesne mase mladičkov.
English: Patients received ivacaftor 25 mg, 50 mg or 75 mg according to their weight at each study visit (see section 4.2).
Slovenian: Bolniki so jemali ivakaftor v odmerku 25 mg, 50 mg ali 75 mg v skladu s svojo telesno maso pri vsakem pregledu zaradi študije (glejte poglavje 4.2).
English: After every 12-hour dosing, steady-state plasma concentrations of ivacaftor were reached by days 3 to 5, with an accumulation ratio ranging from 2.2 to 2.9.
Slovenian: Po odmerjanju vsakih 12 ur so plazemske koncentracije ivakaftorja dosegle stanje dinamičnega ravnovesja v 3 do 5 dneh, pri tem je bilo akumulacijsko razmerje od 2,2 do 2,9.
English: • Once mixed, give the product to your child immediately.
Slovenian: • Ko je mešanica pripravljena, jo naj otrok takoj zaužije.
English: If a dose is missed within 6 hours of the time it is usually taken, the patient should be told to take it as soon as possible and then take the next dose at the regularly scheduled time.
Slovenian: Če bolnik ugotovi, da je pozabil vzeti odmerek, prej kot 6 ur po času, ko ga navadno vzame, mu povejte, naj ga vzame čimprej in potem vzame naslednji odmerek ob redno načrtovanem času.
English: It is a weak inhibitor of CYP3A and P-gp and a potential inhibitor of CYP2C9.
Slovenian: Je šibek zaviralec CYP3A in P-gp in možen zaviralec CYP2C9.
English: If more than 6 hours have passed since the time the dose is usually taken, the patient should be told to wait until the next scheduled dose.
Slovenian: Če je od časa, ko bolnik navadno vzame odmerek, minilo več kot 6 ur, povejte bolniku, naj počaka do naslednjega načrtovanega odmerka.
English: If you plan to breast-feed, ask your doctor for advice before taking Kalydeco.
Slovenian: Če nameravate dojiti, prosite zdravnika za nasvet, preden začnete jemati zdravilo Kalydeco.
English: Ivacaftor is a substrate of CYP3A4 and CYP3A5.
Slovenian: Ivakaftor je substrat CYP3A4 in CYP3A5.
English: Mutation (n) Absolute change in sweat chloride (mmol/L)
Slovenian: Mutacija (n) Absolutna sprememba kloridov v znoju (mmol/l)
English: M6 has less than one-fiftieth the potency of ivacaftor and is not considered pharmacologically active.
Slovenian: M6 ima manj kot eno petdesetinko jakosti ivakaftorja in ne velja za farmakološko aktivnega.
English: • Inner ear disorder (feeling dizzy or spinning)
Slovenian: • bolezen notranjega ušesa (občutek omotičnosti ali vrtenja)
English: A pre-planned subgroup analysis was conducted in patients 18 years and older (26 patients on placebo and 24 on ivacaftor).
Slovenian: Vnaprej načrtovano analizo podskupin so opravili pri bolnikih, starih 18 let ali več (26 bolnikov na placebu in 24 na ivakaftorju).
English: Some examples of age-appropriate soft foods or liquids include puréed fruits or vegetables, yogurt, applesauce, water, milk, breast milk, infant formula, or juice.
Slovenian: Primeri za starost primerne mehke hrane ali tekočine so sadna ali zelenjavna kaša, jogurti, jabolčni sok, voda, mleko, materino mleko, adaptirano mleko za dojenčke ali sok.
English: • if you are allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na ivakaftor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Kalydeco (alone or in combination with tezacaftor/ivacaftor) should only be used if you have one of the mutations in the CFTR gene indicated in section 1 (What Kalydeco is and what it is used for).
Slovenian: • Zdravilo Kalydeco (samo ali v kombinaciji s tezakaftorjem/ivakaftorjem) se sme uporabljati samo, če imate na svojem genu CFTR eno od mutacij, ki so navedene v poglavju 1 (Kaj je zdravilo Kalydeco in za kaj ga uporabljamo).
English: No patients had elevations in total bilirubin.
Slovenian: Pri nobenem bolniku ni bil zvišan celotni bilirubin.
English: There are no data available on the effect of ivacaftor on fertility in humans.
Slovenian: Podatkov o vplivu ivakaftorja na plodnost pri ljudeh ni na voljo.