natgillin/translations-raw huggingface dataset:
• Increase of an enzyme in your blood (blood creatine phosphokinase) 
• zvišanje encima (kreatin-fosfokinaze) v vaši krvi,
Swallow the tablets whole. 
Tablete pogoltnite cele.
Therefore, concomitant use of lumacaftor/ivacaftor with CYP3A substrates may decrease the exposure of these substrates (see section 4.4). 
Zato lahko sočasna uporaba lumakaftorja/ivakaftorja s substrati CYP3A zmanjša izpostavljenost tem substratom (glejte poglavje 4.4).
Clinical experience in patients with ppFEV1 < 40 is limited and additional monitoring of these patients is recommended during initiation of therapy (see section 4.8). 
Kliničnih izkušenj pri bolnikih s ppFEV1 < 40 je malo in med uvajanjem zdravljenja priporočajo dodatno spremljanje teh bolnikov (glejte poglavje 4.8).
Following resolution of transaminase elevations, the benefits and risks of resuming dosing should be considered (see sections 4.2, 4.8, and 5.2). 
Potem ko zvišanja transaminaz izzvenijo, je treba pretehtati koristi in tveganja ponovnega odmerjanja (glejte poglavja 4.2, 4.8 in 5.2).
Taking Orkambi with fat-containing food is important to get the right levels of medicine in the body. 
Jemanje zdravila Orkambi z mastno hrano je pomembno za doseganje ustreznih koncentracij zdravila v telesu.
Especially tell your doctor if you take any of the following medicines: 
Zdravniku še posebno povejte, če jemljete katero od naslednjih zdravil:
The impact of mild hepatic impairment (Child-Pugh Class A, score 5 to 6) on pharmacokinetics of lumacaftor given in combination with ivacaftor has not been studied, but the increase in exposure is expected to be less than 50%. 
Vpliva blage okvare jeter (razred A po Child-Pughovi lestvici, rezultat 5 do 6) na farmakokinetiko lumakaftorja, dajanega v kombinaciji z ivakaftorjem, niso raziskovali, vendar se pričakuje, da je zvečanje izpostavljenosti manj kot 50 %.
Do not chew, break, or dissolve the tablets. 
Tablet ne žvečite, ne drobite in ne raztapljajte.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of lumacaftor/ivacaftor in pregnant women. 
Podatkov o uporabi lumakaftorja/ivakaftorja pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
Increased blood pressure 
Zvišan krvni tlak
In healthy subjects, the half-life of ivacaftor when given with lumacaftor is approximately 9 hours. 
Pri zdravih osebah je bil razpolovni čas ivakaftorja, če so ga dajali z lumakaftorjem, približno 9 ur.
Due to potential induction or inhibition of P-gp 
Zaradi možne indukcije ali zaviranja P-gp
Important information about the contents of Orkambi This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free'. 
Pomembne informacije o vsebini zdravila Orkambi To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Proportion of patients with ≥5% relative change in ppFEV1 at Week 24 
Delež bolnikov z ≥ 5 % relativno spremembo ppFEV1 v
Tell your child's doctor straight away if your child has any of these symptoms, which may be a sign of liver problems: 
Obvestite otrokovega zdravnika, če ima vaš otrok katerega od teh simptomov, ki bi bil lahko znak težav z jetri:
Especially tell the doctor if your child takes any of the following medicines: 
Še zlasti pa povejte zdravniku, če otrok jemlje katero od naslednjih zdravil:
CYP2B6 and CYP2C substrates 
Substrati CYP2B6 in CYP2C
An alternative to these antibiotics, such as azithromycin, should be considered. 
Razmisliti je treba o uporabi drugih antibiotikov, na primer azitromicina.
Table 8: Summary of secondary outcomes in Trial 8 
Preglednica 8: Povzetek sekundarnih izidov v preskušanju 8 Sekundarna končna stanja*
Blood creatine phosphokinase increased uncommon Blood pressure increased 
pogosti zvišana kreatin-fosfokinaza v krvi občasni zvišan krvni tlak
Therefore, after weighing the risks and benefits of treatment, Orkambi should be used with caution at a reduced dose (see sections 4.4, 4.8, and 5.2). 
Zato je treba po presoji tveganja in koristi zdravljenja zdravilo Orkambi previdno uporabljati v zmanjšanem odmerku (glejte poglavja 4.4, 4.8 in 5.2).
Due to the induction effect of lumacaftor on CYP3A, at steady-state, the net exposure of ivacaftor when co-administered with a CYP3A inhibitor is not expected to exceed that when given in the absence of lumacaftor at a dose of 150 mg every 12 hours, the approved dose of ivacaftor monotherapy. 
Zaradi indukcijskega učinka lumakaftorja na CYP3A v stanju dinamičnega ravnovesja ni pričakovati, da bi neto izpostavljenost ivakaftorju, kadar ga dajemo sočasno z zaviralcem CYP3A, presegla tisto pri dajanju brez lumakaftorja v odmerku 150 mg vsakih 12 ur, kar je odobreni odmerek monoterapije z ivakaftorjem.
There are different strengths of Orkambi tablet for different age groups. 
Za različne starostne skupine so na voljo različne jakosti tablet zdravila Orkambi.
METHOD AND ROUTE(S) OF ADMINISTRATION Instructions for use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Navodilo za uporabo
If you forget to take Orkambi 
Če ste pozabili vzeti zdravilo Orkambi
• Severe liver problems: the dose may be reduced to one sachet per day, or less often. 
• Resne težave z jetri: odmerek se lahko zmanjša na eno vrečico na dan ali še redkeje.
↓ citalopram, escitalopram, sertraline 
↓ citalopram, escitalopram, sertralin
The exposures of ivacaftor and the anticonvulsant may be significantly decreased, which may reduce the efficacy of both active substances. 
Izpostavljenost ivakaftorju in antikonvulzivu se lahko znatno zmanjša, kar lahko zmanjša učinkovitost obeh učinkovin.
This medicine contains less than 1 mmole sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Seven patients who received lumacaftor/ivacaftor had liver-related serious adverse events with elevated transaminases, including 3 with concurrent elevation in total bilirubin. 
Sedem bolnikov, ki so prejemali lumakaftor/ivakaftor, je imelo z jetri povezane resne neželene učinke z zvišanimi transaminazami, vključno s tremi, ki so imeli sočasno zvišanje celotnega bilirubina.
If you take more Orkambi than you should 
Če ste vzeli večji odmerek zdravila Orkambi, kot bi smeli
Ivacaftor was not teratogenic when dosed orally to pregnant rats and rabbits during the organogenesis stage of foetal development at doses approximately 7 times (ivacaftor and metabolite exposure) and 46 times the ivacaftor exposure in humans at the therapeutic lumacaftor/ivacaftor dose, respectively. 
Ivakaftor ni bil teratogen, kadar so ga peroralno dajali brejim samicam podgan in kuncev med stadijem organogeneze fetalnega razvoja v odmerkih, ki so približno 7-krat (izpostavljenost ivakaftorju in presnovkom) oziroma 46-krat presegli izpostavljenost ivakaftorju pri ljudeh ob terapevtskem odmerku lumakaftorja/ivakaftorja.
Findings of cataracts were observed in juvenile rats dosed with ivacaftor at 0.32 times the maximum recommended human dose based on systemic exposure of ivacaftor and its metabolites when co-administered with lumacaftor as Orkambi. 
Katarakte so ugotovili pri mladih podganah, ki so prejemale 0,32-kratnik največjega priporočenega odmerka za človeka na podlagi sistemske izpostavljenosti ivakaftorju in njegovim presnovkom, ko so ga dajali sočasno z lumakaftorjem v obliki zdravila Orkambi.
A double dose should not be taken to make up for the forgotten dose. 
Bolnik ne sme vzeti dvojnega odmerka, da bi nadomestil pozabljeni odmerek.
Very common may affect more than 1 in 10 people: 
Zelo pogosti se lahko pojavijo pri več kot 1 od 10 bolnikov:
While taking Orkambi, you may notice that your breathing is easier, that you do not get ill as often, and/or that it is easier to gain weight. 
Med jemanjem zdravila Orkambi boste mogoče opazili, da lažje dihate, da ne zbolite tako pogosto in/ali da lažje pridobite telesno maso.
Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate 
Ime in naslov izdelovalca, odgovornega za sproščanje serij Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
• Anti-inflammatory medicines (used for the treatment of inflammation) for example: ibuprofen 
• protivnetna zdravila (uporabljajo se za zdravljenje vnetja), na primer: ibuprofen;
Adverse reactions observed with ivacaftor alone are also provided in Table 4. 
Neželeni učinki, ki so jih ugotovili pri ivakaftorju samem, so tudi navedeni v preglednici 4.
• This medicine has been prescribed for your child only. 
• Zdravilo je bilo predpisano le vašemu otroku in ga ne smete dajati drugim.
Co-administration of Orkambi with medicinal products that inhibit BCRP may increase plasma lumacaftor concentration. 
Sočasno dajanje zdravila Orkambi z zdravili, ki zavirajo BRCP, lahko zviša koncentracijo lumakaftorja v plazmi.
The safety and efficacy of Orkambi in patients aged 65 years or older have not been evaluated. 
Varnosti in učinkovitosti zdravila Orkambi pri bolnikih, starih 65 let ali več, niso ocenjevali.
• Yellowing of the skin or the white part of the eyes 
• porumenitev kože ali očesnih beločnic,
In vitro and in vivo data indicate that lumacaftor is mainly metabolised via oxidation and glucuronidation. 
Podatki in vitro in in vivo kažejo, da se lumakaftor v glavnem presnavlja z oksidacijo in glukuronidacijo.
Clinical comment erythromycin 
Klinični komentar eritromicin
Trial 8 evaluated 60 patients aged 2 to 5 years at screening (mean age at baseline 3.7 years). 
V preskušanju 8 so ocenjevali 60 bolnikov, ki so bili ob presejanju stari 2 do 5 let (povprečna starost v izhodišču 3,7 let).
Two patients in the lumacaftor/ivacaftor group and two patients in the placebo group discontinued treatment permanently due to transaminase elevations. 
Dva bolnika v skupini, ki je prejemala lumakaftor/ivakaftor, in dva bolnika v skupini s placebom sta trajno prenehala z zdravljenjem zaradi zvišanja transaminaz.
Cataracts were not observed in foetuses derived from rat dams treated during the organogenesis stage of foetal development, in rat pups exposed to a certain extent through milk ingestion prior to weaning, or in repeated dose toxicity studies with ivacaftor. 
Katarakt niso ugotovili pri plodovih podganjih samic, ki so zdravilo prejemale med stadijem organogeneze fetalnega razvoja, pri podganjih mladičih, ki so bili v določeni meri pred odstavitvijo od prsi izpostavljeni preko materinega mleka, ali v študijah toksičnosti ponavljajočih se odmerkov ivakaftorja.
*Side effects seen for ivacaftor alone. 
*Neželeni učinki, ki so jih opazili pri ivakaftorju samem.
Table 1: Recommended dose of Orkambi in patients aged 6 years and older Age 
Preglednica 1: Priporočeni odmerek zdravila Orkambi za bolnike, stare 6 let ali več Starost
Lumacaftor is not extensively metabolised in humans, with the majority of lumacaftor excreted unchanged in the faeces. 
Lumakaftor se pri ljudeh ne presnavlja izdatno, večinoma se nespremenjen izloči v blatu.
Ivacaftor may cause dizziness (see section 4.8). 
Ivakaftor lahko povzroča omotico (glejte poglavje 4.8).
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from lumacaftor/ivacaftor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom lumakaftor/ivakaftor, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
No dose adjustment 
brez prilagoditve odmerka
Lumacaftor had no effects on fertility and reproductive performance indices in male and female rats. 
Lumakaftor ni vplival na indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan.
The event occurred within 5 days of the start of dosing and resolved following discontinuation of lumacaftor/ivacaftor (see section 4.4). 
Do dogodka je prišlo v 5 dneh po začetku odmerjanja, po ukinitvi lumakaftorja/ivakaftorja pa se je razrešil (glejte poglavje 4.4).
The percentage of patients with heart rate values < 50 bpm on treatment was 11% for patients who received lumacaftor/ivacaftor, compared to 4.9% for patients who received placebo. 
Odstotni delež bolnikov z vrednostmi srčne frekvence < 50 bpm med zdravljenjem je bil 11 % pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem, v primerjavi s 4,9 % pri bolnikih, ki so prejemali placebo.
No specific antidote is available for overdose with lumacaftor/ivacaftor. 
Specifičen antidot za prevelik odmerek lumakaftorja/ivakaftorja ni na voljo.
The safety data from 1029 patients aged 12 years and older who were homozygous for the F508del mutation in the CFTR gene treated with lumacaftor/ivacaftor for up to an additional 96 weeks in the long-term safety and efficacy rollover study (Trial 3) were similar to the 24-week, placebo-controlled studies (see section 5.1). 
Varnostni podatki pri 1029 bolnikih, starih 12 let ali starejših, ki so bili homozigotni za mutacijo F508del na genu CFTR, zdravljenih z lumakaftorjem/ivakaftorjem največ dodatnih 96 tednov v dolgoročni obnovitveni študiji varnosti in učinkovitosti (preskušanje 3), so bili podobni kot v 24-tedenskih, s placebom kontroliranih študijah (glejte poglavje 5.1).
Orkambi should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene. 
Zdravilo Orkambi se sme uporabljati samo pri bolnikih, ki imajo dve kopiji mutacije F508del na svojem genu CFTR.
You can help by reporting any side effects your child may get. 
Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vašem otroku.
• Severe liver problems: the dose may be reduced to one tablet every 12 hours. 
• Resne težave z jetri: odmerek se lahko zmanjša na eno tableto na 12 ur.
Among different age paediatric cohorts, in the 2 to 5 years old patients, transaminase elevations have been observed more frequently than in the 6 to 11 years old (see section 4.8). 
Med pediatričnimi kohortami različnih starosti so zvišanja transaminaz pogosteje ugotavljali pri bolnikih, starih 2 do 5 let, kot pri bolnikih, starih 6 do 11 let (glejte poglavje 4.8).
The exposure of ivacaftor will be decreased, which may reduce the efficacy of lumacaftor/ivacaftor. 
Izpostavljenost ivakaftorju se bo zmanjšala, kar lahko zmanjša učinkovitost lumakaftorja/ivakaftorja.
• Benzodiazepines (used for the treatment of anxiety or sleeplessness [insomnia], agitation, etc.) for example: midazolam, triazolam 
• benzodiazepini (uporabljajo se za zdravljenje tesnobe (anksioznosti) ali nespečnosti [insomnije], vznemirjenosti itn.), na primer: midazolam, triazolam;
Table 4: Adverse reactions in lumacaftor/ivacaftor-treated patients and in patients treated with ivacaftor alone 
Preglednica 4: Neželeni učinki pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem, in pri bolnikih, zdravljenih samo z ivakaftorjem
St. John's wort (Hypericum perforatum) 
šentjanževka (Hypericum perforatum);
Three patients discontinued lumacaftor/ivacaftor treatment permanently due to transaminase elevations. 
Trije bolniki so se trajno prenehali zdraviti z lumakaftorjem/ivakaftorjem zaradi zvišanih transaminaz.
• Anti-allergic medicines (used for the treatment of allergies and/or asthma) for example: montelukast, fexofenadine 
• zdravila proti alergijam (uporabljajo se za zdravljenje alergij in/ali astme), na primer: montelukast, feksofenadin;
Potential for lumacaftor/ivacaftor to interact with transporters In vitro experiments show that lumacaftor is a substrate for Breast Cancer Resistance Protein (BCRP). 
Potencial lumakaftorja/ivakaftorja za medesebojno delovanje s prenašalci Poskusi in vitro kažejo, da je lumakaftor substrat beljakovine odpornosti pri raku dojke (Breast Cancer Resistance Protein - BCRP).
If you forget to give your child Orkambi 
Če ste pozabili otroku dati zdravilo Orkambi
** For patients rolled over from Trials 1 and 2 (placebo-to-lumacaftor/ivacaftor group) total exposure was up to 96 weeks. 
** Pri bolnikih, ki so nadaljevali iz preskušanj 1 in 2 (skupina, ki je prejemala najprej placebo, nato lumakaftor/ivakaftor), je trajala skupna izpostavljenost do 96 tednov.
The serum concentration of digoxin should be monitored and the dose should be titrated to obtain the desired clinical effect. 
Treba je spremljati koncentracijo digoksina v serumu in titrirati odmerek, da bomo dosegli želeni klinični učinek.
In addition, the mean absolute change in sweat chloride from Week 24 at Week 26 following the 2-week washout period (to evaluate off-drug response) was an increase of 33.0 mmol/L (95% CI: 28.9, 37.1; nominal P < 0.0001), representing a return to baseline after treatment washout. 
Poleg tega je bila povprečna absolutna sprememba kloridov v znoju od 24. tedna v 26. tednu po dvotedenskem obdobju spiranja (za ocenjevanje odziva brez prejemanja zdravila) zvečanje za 33,0 mmol/l (95 % IZ: 28,9, 37,1; nominalna P < 0,0001), ki predstavlja povratek na izhodišče po spiranju zdravila.
Patients treated with lumacaftor/ivacaftor in Trial 1 or Trial 2 showed an effect that was maintained with respect to baseline after an additional 96 weeks through Trial 3. 
Bolniki, zdravljeni z lumakaftorjem/ivakaftorjem v preskušanju 1 ali preskušanju 2, so pokazali učinek, ki je glede na izhodišče trajal še dodatnih 96 tednov do konca preskušanja 3.
• Abdominal pain (stomach ache) 
• abdominalna bolečina (bolečina v trebuhu)*,
Give the missed dose with fat-containing food if less than 6 hours have passed since the time your child missed the dose. 
Dajte mu izpuščeni odmerek z mastno hrano, če je preteklo manj kot 6 ur od takrat, ko bi otrok moral dobiti odmerek.
The exposure of ivacaftor when given in combination with lumacaftor increased approximately 3-fold when given with fat-containing food in healthy volunteers. 
Izpostavljenost ivakaftorju, ko so ga dajali skupaj z lumakaftorjem, se je zvečala za približno trikrat, če so ju dajali z mastno hrano zdravim prostovoljcem.
The efficacy of lumacaftor/ivacaftor in patients with CF who are homozygous for the F508del mutation in the CFTR gene was evaluated in two randomised, double-blind, placebo-controlled clinical trials of 1108 clinically stable patients with CF, in which 737 patients were randomised to and dosed with lumacaftor/ivacaftor. 
Učinkovitost lumakaftorja/ivakaftorja pri bolnikih s CF, ki so homozigotni za mutacijo F508del na genu CFTR, so ovrednotili v dveh randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih preskušanjih 1108 klinično stabilnih bolnikov s CF, v katerih je bilo 737 bolnikov randomiziranih na lumakaftor/ivakaftor, ki so ga nato prejemali.
Lumacaftor is a strong inducer of CYP3A. 
Lumakaftor je močan induktor CYP3A.
The combined effect of lumacaftor and ivacaftor is increased quantity and function of F508del-CFTR at the cell surface, resulting in increased chloride ion transport. 
Kombinirani učinek lumakaftorja in ivakaftorja je zvečana količina in funkcionalnost F508del-CFTR na celični površini, kar povzroči zvečan transport kloridnih ionov.
Appropriate clinical monitoring should be employed, as is reasonable, when co-administered with lumacaftor/ivacaftor. 
Uporabiti je treba ustrezno klinično spremljanje, kot je primerno, kadar se uporablja sočasno z lumakaftorjem/ivakaftorjem.
In lumacaftor/ivacaftor-treated patients, approximately two-thirds of these reactions resolved, and the median duration was 10 days. 
Pri bolnicah, zdravljenih z lumakaftorjem/ivakaftorjem, sta se približno dve tretjini teh reakcij razrešili,
The safety and efficacy of Orkambi in children aged less than 2 years have not yet been established. 
Varnost in učinkovitost zdravila Orkambi pri otrocih, mlajših od 2 let, še nista bili dokazani.
Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop lumacaftor/ivacaftor therapy. 
Zdravnik se bo odločil, ali naj vam svetuje prenehanje dojenja ali prekinitev zdravljenja z lumakaftorjem/ivakaftorjem.
Following discontinuation of lumacaftor/ivacaftor, liver function tests returned to baseline or improved substantially in all patients (see section 4.4). 
Po ukinitvi lumakaftorja/ivakaftorja so se testi funkcije jeter pri vseh bolnikih vrnili na izhodiščne vrednosti ali bistveno izboljšali (glejte poglavje 4.4).
If your child takes more Orkambi than he/she should Contact your child's doctor or pharmacist for advice. 
Če je vaš otrok vzel večji odmerek zdravila Orkambi, kot bi smel Obrnite se na otrokovega zdravnika ali farmacevta za nasvet.
If lumacaftor/ivacaftor is used in these patients, they should be closely monitored after the initiation of treatment and the dose should be reduced (see sections 4.2, 4.8, and 5.2). 
Če uporabljamo lumakaftor/ivakaftor pri teh bolnikih, jih moramo po uvedbi zdravljenja skrbno spremljati, odmerek pa moramo zmanjšati (glejte poglavja 4.2, 4.8 in 5.2).
Treatment with lumacaftor/ivacaftor resulted in no significant improvement in ppFEV1 relative to placebo in patients with CF heterozygous for the F508del mutation in the CFTR gene (treatment difference 0.60 [P = 0.5978]) and no meaningful improvements in BMI or weight (see section 4.4). 
Zdravljenje z lumakaftorjem/ivakaftorjem ni povzročilo niti signifikantnega izboljšanja ppFEV1 glede na placebo pri bolnikih s CF, heterozigotnih za mutacijo F508del na genu CFTR (razlika zaradi zdravljenja 0,60 [P = 0,5978]) niti pomembnih izboljšanj ITM ali telesne mase (glejte poglavje 4.4).
Secondary endpoints included absolute change from baseline in sweat chloride at Week 24 and absolute change in sweat chloride from Week 24 at Week 26 (see Pharmacodynamic effects) as well as the endpoints listed in Table 8. 
Sekundarna končna stanja so vključevala absolutno spremembo kloridov v znoju od izhodišča v 24. tednu in absolutno spremembo kloridov v znoju od 24. tedna v 26. tednu (glejte Farmakodinamični učinki), pa tudi končna stanja, navedena v preglednici 8.
Immunosuppressants: ciclosporin, everolimus, sirolimus, tacrolimus (used after organ transplant) 
Zdravila za zaviranje imunske odzivnosti: ciklosporin, everolimus, sirolimus, takrolimus (uporabljajo se po presaditvi organov)
While taking Orkambi, you may notice that your child's breathing is easier, that they do not get ill as often, and/or that it is easier to gain weight. 
Med jemanjem zdravila Orkambi boste mogoče opazili, da vaš otrok lažje diha, da ne zboli tako pogosto in/ali da lažje pridobi telesno maso.
• Printing ink: shellac; iron oxide black (E172); propylene glycol; and ammonium hydroxide. 
• tiskarsko črnilo: šelak; črni železov oksid (E172); propilenglikol; in amonijev hidroksid.
• Obligation to conduct post-authorisation measures: 
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji ukrep:
In the subgroup of 28 patients who were initiated at the full dose of lumacaftor/ivacaftor (2 tablets every 12 hours), the incidence was 71.4%, and in the 18 patients who were initiated at a reduced dose of lumacaftor/ivacaftor (1 tablet every 12 hours for up to 2 weeks, and subsequently increased to the full dose), the incidence was 55.6%. 
V podskupini 28 bolnikov, ki so jim uvedli lumakaftor/ivakaftor v polnem odmerku (2 tableti vsakih 12 ur), je bila incidenca 71,4 %, pri 18 bolnikih, ki so jim uvedli lumakaftor/ivakaftor v zmanjšanem odmerku (1 tableta vsakih 12 ur do 2 tedna, nato pa zvečanje na polni odmerek), pa je bila incidenca 55,6 %.
The side effects reported with Orkambi and ivacaftor alone (one of the active substances of Orkambi) are listed below and may occur with the use of Orkambi. 
Neželeni učinki, o katerih poročajo pri zdravilu Orkambi in pri ivakaftorju samem (ena od učinkovin zdravila Orkambi), so navedeni v nadaljevanju in se lahko pojavijo pri jemanju zdravila Orkambi.
Trial 7 was a 24-week, placebo-controlled, Phase 3 clinical study in 204 patients with CF aged 6 to 11 years old (mean age 8.8 years). 
Preskušanje 7 je bila 24-tedenska, s placebom kontrolirana klinična študija faze 3 pri 204 bolnikih s CF, starih 6 do 11 let (povprečna starost 8,8 leta).
Relative change in ppFEV1 at Week 24 (%) 
Relativna sprememba ppFEV1 v 24. tednu (%)