natgillin/translations-raw huggingface dataset:
Following multiple oral doses of lumacaftor, the exposure of lumacaftor generally increased proportional to dose over the range of 50 mg to 1000 mg every 24 hours.
Po dajanju večkratnih peroralnih odmerkov lumakaftorja se je izpostavljenost lumakaftorju na splošno zvečevala sorazmerno odmerku v razponu od 50 mg do 1000 mg na 24 ur.
Respiratory events (e.g., chest discomfort, dyspnoea, and respiration abnormal) were more common during initiation of lumacaftor/ivacaftor therapy.
Respiratorni dogodki (npr. neugodje v prsih, dispneja in nenormalno dihanje) so bili pogostejši med uvajanjem zdravljenja z lumakaftorjem/ivakaftorjem.
Additionally, in vitro studies suggest that ivacaftor may inhibit CYP2C9.
Poleg tega študije in vitro kažejo, da ivakaftor lahko zavira CYP2C9.
Take the missed dose with fat-containing food if less than 6 hours have passed since the time you missed the dose.
Vzemite izpuščeni odmerek z mastno hrano, če je preteklo manj kot 6 ur od takrat, ko ste izpustili odmerek.
Lumacaftor increases the amount of CFTR available and ivacaftor helps the abnormal protein to work more normally.
Lumakaftor zvečuje količino CFTR, ki je na voljo, ivakaftor pa pomaga nenormalni beljakovini bolj normalno delovati.
At maternally toxic doses in rats, ivacaftor produced reductions in foetal body weight; an increase in the incidence of variations in cervical ribs, hypoplastic ribs, and wavy ribs; and sternal irregularities, including fusions.
Pri podganah je ivakaftor v odmerkih, toksičnih za mater, povzročil zmanjšanje telesne mase plodov; zvečanje pogostnosti variacij cervikalnih reber, hipoplastičnih reber in valovite deformacije reber; in nepravilnosti prsnice, vključno s fuzijami.
The event rate per year, annualised to 48 weeks, was 0.70 in the lumacaftor/ivacaftor group and 1.14 in the placebo group.
Pogostnost dogodkov na leto, preračunana na 48 tednov, je bila 0,70 v skupini z lumakaftorjem/ivakaftorjem in 1,14 v skupini s placebom.
The safety and efficacy of lumacaftor/ivacaftor in patients age 65 years or older have not been evaluated.
Starejši Varnosti in učinkovitosti lumakaftorja/ivakaftorja pri bolnikih, starih 65 let ali več, niso ocenjevali.
In a human pharmacokinetic study with lumacaftor alone, there was minimal elimination of lumacaftor and its metabolites in urine (only 8.6% of total radioactivity was recovered in the urine with 0.18% as unchanged parent).
V farmakokinetični študiji na ljudeh samo z lumakaftorjem so ugotovili minimalno odstranjevanje lumakaftorja in njegovih presnovkov v urinu (samo 8,6 % celotne radioaktivnosti so prestregli v urinu, od tega je bilo 0,18 % v obliki nespremenjene izhodne snovi).
Table 7: Summary of primary and key secondary outcomes in Trial 7
Preglednica 7: Povzetek primarnih in ključnih sekundarnih ciljev v preskušanju 7
Patients with advanced liver disease
Bolniki z napredovalo boleznijo jeter
You may experience side effects, including those mentioned in section 4 below.
Mogoče boste dobili neželene učinke, vključno s tistimi, ki so omenjeni v poglavju 4 v nadaljevanju.
• Moderate liver problems: the dose may be reduced to two tablets in the morning and one tablet in the evening.
• Zmerne težave z jetri: odmerek se lahko zmanjša na dve tableti zjutraj in eno tableto zvečer.
Following oral administration of ivacaftor alone, the majority of ivacaftor (87.8%) is eliminated in the faeces after metabolic conversion.
Po peroralnem dajanju ivakaftorja samega se večina ivakaftorja (87,8 %) po presnovnem preoblikovanju izloči v blatu.
Giving Orkambi granules to your child:
Dajanje zrnc zdravila Orkambi otroku:
• 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.