FrancophonIA/ELRC3.0 huggingface dataset:
English: Presentation of the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h dose group is consistent with recommended posology.
Slovenian: Rezultati skupine z odmerkom lumakaftorja 400 mg/12 h/ivakaftorja 250 mg/12 h so skladni s priporočenim odmerjanjem.
English: Due to induction of CYP3A by LUM
Slovenian: Zaradi indukcije CYP3A z LUM
English: The primary efficacy endpoint was absolute change in LCI2.5 from baseline through Week 24.
Slovenian: Primarni učinkovitostni cilj študije je bila absolutna sprememba LCI2,5 od izhodišča do 24. tedna.
English: Always give your child this medicine exactly as your child's doctor has told you.
Slovenian: Pri dajanju tega zdravila svojemu otroku natančno upoštevajte navodila otrokovega zdravnika.
English: Component of a multipack, cannot be sold separately
Slovenian: Prodaja posamezne enote ni možna.
English: During the 24-week, placebo-controlled Phase 3 clinical study in 204 patients aged 6 to 11 years (Trial 7), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 1.0%, 4.9%, and 12.6% in the lumacaftor/ivacaftor patients, and 2.0%, 3.0%, and 7.9% in the placebo-treated patients.
Slovenian: Med 24-tedensko s placebom kontrolirano klinično študijo faze 3 pri 204 bolnikih, starih 6 do 11 let (preskušanje 7), je bila incidenca najvišjih ravni transaminaze (ALT ali AST) > 8, > 5 in > 3 x ULN 1,0 %, 4,9 % oziroma 12,6 % pri bolnikih, ki so jemali lumakaftor/ivakaftor, in 2,0 %, 3,0 % oziroma 7,9 % pri bolnikih, ki so prejemali placebo.
English: rifapentine
Slovenian: rifapentin
English: ↔ LUM
Slovenian: z LUM
English: If Orkambi is interrupted for more than one week and then re-initiated while taking strong CYP3A inhibitors, the Orkambi dose should be reduced to one sachet (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 2 to 5 years and weighing less than 14 kg; lumacaftor 150 mg/ivacaftor 188 mg for patients aged 2 to 5 years and weighing 14 kg or greater) every other day for the first week of treatment re-initiation.
Slovenian: Če dajanje zdravila Orkambi prekinemo za več kot en teden in ga nato spet začnemo dajati, medtem ko bolnik jemlje močne zaviralce CYP3A, moramo odmerek zdravila Orkambi zmanjšati na eno vrečico (lumakaftor 100 mg/ivakaftor 125 mg za bolnike, stare 2 do 5 let, ki tehtajo manj kot 14 kg; lumakaftor 150 mg/ivakaftor 188 mg za bolnike, stare 2 do 5 let, ki tehtajo 14 kg ali več) vsak drugi dan za prvi teden ponovnega začetka zdravljenja.
English: Post-Authorisation Efficacy Study (PAES) Based on an agreed protocol, the Applicant should conduct a long-term effectiveness study to compare disease progression among children with CF homozygous for F508del-CFTR and are aged 2 through 5 years at the time of Orkambi treatment initiation versus disease progression among concurrent matched cohort of children with CF who have never received Orkambi treatment, in addition to a longitudinal historical cohort.
Slovenian: homozigotnih za F508del-CFTR, starih 2 leti do 5 let v času uvedbe zdravljenja z zdravilom Orkambi, z napredovanjem bolezni pri sočasni kohorti otrok s CF s primerljivimi demografskimi značilnostmi, ki niso nikoli prejeli zdravljenja z zdravilom Orkambi, poleg longitudinalne zgodovinske kohorte.
English: The international normalised ratio (INR) should be monitored when warfarin co-administration with lumacaftor/ivacaftor is required.
Slovenian: Kadar je potrebna sočasna uporaba varfarina z lumakaftorjem/ivakaftorjem, je treba spremljati mednarodno normalizirano razmerje (INR-international normalised ratio).
English: Trial 1 evaluated 549 patients with CF who were aged 12 years and older (mean age 25.1 years) with percent predicted FEV1 (ppFEV1) at screening between 40-90 (mean ppFEV1 60.7 at baseline [range: 31.1 to 94.0]).
Slovenian: V preskušanju 1 so ovrednotili 549 bolnikov s CF, ki so bili stari 12 let ali več (povprečna starost 25,1 leta) z napovedanim FEV1 v odstotkih (ppFEV1) ob presejanju med 40 in 90 (povprečni ppFEV1 60,7 v izhodišču [razpon: 31,1 do 94,0]).
English: Anticonvulsants: carbamazepine, phenobarbital, phenytoin
Slovenian: karbamazepin, fenobarbital, fenitoin
English: No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with fluconazole.
Slovenian: Prilagajanja odmerka lumakaftorja/ivakaftorja ne priporočajo, kadar se uporablja sočasno s flukonazolom.
English: During the 24-week, open-label Phase 3 clinical study (Trial 6) in 58 patients aged 6 to 11 years (mean baseline ppFEV1 was 91.4), the incidence of respiratory adverse reactions was 6.9% (4/58).
Slovenian: Med 24-tedensko odprto klinično študijo faze 3 (preskušanje 6) pri 58 bolnikih, starih 6 do 11 let (povprečni izhodiščni ppFEV1 je bil 91,4), je bila incidenca respiratornih neželenih učinkov 6,9 %
English: Tell your child's doctor straight away if he/she gets any of these:
Slovenian: Nemudoma obvestite otrokovega zdravnika, če se pri otroku pojavi:
English: No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with erythromycin.
Slovenian: Prilagajanja odmerka lumakaftorja/ivakaftorja ne priporočajo, kadar se uporablja sočasno z eritromicinom.
English: n = 57 95% CI: 0.07, 0.47; P = 0.0091
Slovenian: 95 % IZ: 0,07, 0,47; P = 0,0091
English: During the 24-week, placebo-controlled Phase 3 clinical study (Trial 7) in patients aged 6 to 11 years (mean baseline ppFEV1 was 89.8), the incidence of respiratory adverse reactions was 18.4% in lumacaftor/ivacaftor patients and 12.9% in placebo patients.
Slovenian: Med 24-tedensko s placebom kontrolirano klinično študijo faze 3 (preskušanje 7) pri bolnikih, starih 6 do 11 let (povprečni izhodiščni ppFEV1 je bil 89,8), je bila incidenca respiratornih neželenih učinkov 18,4 % pri bolnikih, ki so jemali lumakaftor/ivakaftor, in 12,9 % pri bolnikih s placebom.
English: What you need to know before you take Orkambi Do not take Orkambi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Orkambi Ne jemljite zdravila Orkambi
English: Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli/pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: A population pharmacokinetic analysis of clearance versus creatinine clearance shows no trend for subjects with mild and moderate renal impairment (see section 4.2).
Slovenian: Populacijska farmakokinetična analiza očistka proti očistku kreatinina pri bolnikih z blago in zmerno okvaro ledvic ni pokazala trenda
English: Therefore, lumacaftor/ivacaftor should be administered with fat-containing food.
Slovenian: Zato je treba dajati lumakaftor/ivakaftor z mastno hrano.
English: A higher dose of these antidepressants may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek teh antidepresivov, da bomo dosegli želeni klinični učinek.
English: Ivacaftor, which is one of the active components of Orkambi, has a minor influence on the ability to drive or use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Ivakaftor, ki je ena od učinkovin zdravila Orkambi, ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Do not take a double dose to make up for the forgotten tablets.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets).
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 112 filmsko obloženih tablet (4 pakiranja po 28 tablet).
English: Check with the doctor if you are not sure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom.
English: During the 24-week, open-label Phase 3 clinical study in 60 patients aged 2 through 5 years (Trial 8), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 8.3% (5/60), 11.7% (7/60), and 15.0% (9/60).
Slovenian: Med 24-tedensko odprto klinično študijo faze 3 pri 60 bolnikih, starih 2 leti do 5 let (preskušanje 8), je bila pogostnost najvišjih ravni transaminaz (ALT ali AST) > 8, > 5, oziroma > 3 x ULN 8,3 % (5/60), 11,7 % (7/60) oziroma 15,0 % (9/60).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHETS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: • Herbal medicines, for example: St. John's wort (Hypericum perforatum)
Slovenian: Zdravila rastlinskega izvora: šentjanževka (Hypericum perforatum)
English: n = 57 95% CI: 3.3, 3.9; P < 0.0001
Slovenian: 95 % IZ: 3,3, 3,9; P < 0,0001
English: There was negligible urinary excretion of lumacaftor as unchanged drug.
Slovenian: Količina lumakaftorja, ki se je izločila v urinu kot nespremenjeno zdravilo, je bila zanemarljiva.
English: You may start giving your child Orkambi on any day of the week.
Slovenian: Zdravilo Orkambi lahko začnete otroku dajati katerega koli dne v tednu.
English: Gastrointestinal disorders very common Abdominal pain*, abdominal pain upper, diarrhoea, nausea common
Slovenian: Bolezni prebavil zelo pogosti bolečina v trebuhu*, bolečina v zgornjem delu trebuha, driska, navzea pogosti vetrovi, bruhanje
English: Inducers of CYP3A
Slovenian: Induktorji CYP3A
English: 1 tablet of 200 mg/125 mg in the evening (12 hours later)
Slovenian: 1 tableto po 200 mg/125 mg zvečer (12 ur pozneje)
English: For patients aged 6 to 11 years 2 tablets of 100 mg/125 mg in the morning + 1 tablet of 100 mg/125 mg in the evening (12 hours later)
Slovenian: 2 tableti po 100 mg/125 mg zjutraj + 1 tableto po 100 mg/125 mg zvečer (12 ur pozneje)
English: During a 24-week, open label, Phase 3b clinical study (Trial 5) in 46 patients aged 12 years and older with advanced lung disease (ppFEV1 < 40) [mean ppFEV1 29.1 at baseline (range: 18.3 to 42.0)], the incidence of respiratory events was 65.2%.
Slovenian: Med 24-tedensko odprto klinično študijo faze 3b (preskušanje 5) pri 46 bolnikih, starih 12 let ali več, z napredovalo boleznijo pljuč (ppFEV1 < 40) [srednji ppFEV1 29,1 v izhodišču (razpon: 18,3 do 42,0)],
English: Trial 2 evaluated 559 patients aged 12 years and older (mean age 25.0 years) with ppFEV1 at screening between 40-90 (mean ppFEV1 60.5 at baseline [range: 31.3 to 99.8]).
Slovenian: V preskušanju 2 so ovrednotili 559 bolnikov s CF, ki so bili stari 12 let ali več (povprečna starost 25,0 let) s ppFEV1 ob presejanju med 40 in 90 (povprečni ppFEV1 60,5 v izhodišču [razpon: 31,3 do 99,8]).
English: Respiratory, thoracic and mediastinal disorders very common Nasal congestion, dyspnoea, productive cough, sputum increased common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kongestija nosu, dispneja, produktiven kašelj, zvečano izkašljevanje sputuma pogosti nenormalno dihanje, bolečina v ustih in žrelu,
English: ↓ montelukast Due to the induction of CYP3A/2C8/2C9 by LUM
Slovenian: ↓ montelukast Zaradi indukcije CYP3A/2C8/2C9 z
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WALLET FOR SACHET
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZLOŽENKA ZA VREČICE
English: • Common cold*
Slovenian: • navadni prehlad*,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - SINGLE PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - POSAMEZNO PAKIRANJE
English: Do not stop unless your child's doctor advises you to. You should keep giving the medicine as the doctor directs even if the child feels well.
Slovenian: Otroku morate dajati zdravilo po zdravnikovih navodilih, tudi če se otrok dobro počuti.
English: Menstruation irregular, dysmenorrhoea, metrorrhagia, breast mass* uncommon Menorrhagia, amenorrhoea, polymenorrhoea, breast inflammation*, gynaecomastia*, nipple disorder*, nipple pain*, oligomenorrhoea
Slovenian: občasni menoragija, amenoreja, polimenoreja, vnetje dojke*, ginekomastija*, bolezen bradavice*,
English: One lumacaftor 150 mg/ivacaftor 188 mg sachet every 12 hours lumacaftor 300 mg/ ivacaftor 376 mg
Slovenian: 14 kg ali več ena vrečica lumakaftor 150 mg/ivakaftor 188 mg na 12 ur lumakaftor 300 mg/ ivakaftor 376 mg
English: Caution is recommended while using lumacaftor/ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Slovenian: Pri uporabi lumakaftorja/ivakaftorja pri bolnikih s hudo okvaro ledvic ali boleznijo ledvic v končnem stadiju je priporočljiva previdnost (glejte poglavji 4.2 in 5.2).
English: Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.
Slovenian: Rožnate, ovalne tablete (velikost 14 × 8,4 × 6,8 mm) z natisnjenim napisom “2V125” s črnim črnilom na eni strani.
English: Lumacaftor/ivacaftor may alter the exposure of dabigatran.
Slovenian: Lumakaftor/ivakaftor lahko spremeni izpostavljenost dabigatranu.
English: • Nausea or vomiting
Slovenian: • siljenje na bruhanje (navzea) ali bruhanje,
English: No dose adjustment of lumacaftor/ivacaftor is recommended when clarithromycin or telithromycin are initiated in patients currently taking lumacaftor/ivacaftor.
Slovenian: Prilagajanja odmerka lumakaftorja/ivakaftorja ne priporočajo pri uvajanju klaritromicina ali telitromicina bolnikom, ki trenutno jemljejo lumakaftor/ivakaftor.
English: During the 24-week, open-label Phase 3 clinical study in 58 patients aged 6 to 11 years (Trial 6), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and >3 x ULN was 5.3%, 8.8%, and 19.3%.
Slovenian: Med 24-tedensko odprto klinično študijo faze 3 pri 58 bolnikih, starih 6 do 11 let (preskušanje 6), je bila incidenca najvišjih ravni transaminaze (ALT ali AST) > 8, > 5 in > 3 x ULN 5,3 %, 8,8 % oziroma 19,3 %.
English: ↔ LUM, IVA ↑ or ↓ fexofenadine
Slovenian: ↔ LUM, IVA ↓ metilprednizolon,
English: Cellulose, microcrystalline Croscarmellose sodium Hypromellose acetate succinate Povidone (K30) Sodium laurilsulfate Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza premreženi natrijev karmelozat hipromeloza acetat sukcinat povidon (K30)
English: Concomitant use of lumacaftor/ivacaftor with these benzodiazepines is not recommended.
Slovenian: Sočasne uporabe lumakaftorja/ivakaftorja s temi benzodiazepini ne priporočajo.
English: Absolute change in CFQ-R Respiratory Domain Score Treatment difference
Slovenian: Absolutna sprememba rezultata respiracijske domene CFQ-R do konca
English: Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.
Slovenian: Rožnate, ovalne tablete (velikost 14 × 7,6 × 4,9 mm) z natisnjenim napisom “1V125” s črnim črnilom na eni strani.
English: No effects on male or female fertility and reproductive performance indices were observed at ≤ 100 mg/kg/day (yielding exposures approximately 8 and 5 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 100 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the embryofoetal development study in this species).
Slovenian: Pri odmerkih ≤ 100 mg/kg/dan (ki so povzročili izpostavljenosti, ki so približno 8-krat oziroma 5-krat presegle tiste, ki so bile dosežene z največjim priporočenim odmerkom ivakaftorja (učinkovina zdravila Orkambi) za človeka na podlagi seštetih AUC ivakaftorja in njegovih presnovkov, ekstrapoliranih iz izpostavljenosti 90. dne pri odmerku 100 mg/kg/dan v 6-mesečni študiji toksičnosti ponavljajočih se odmerkov, in izpostavljenosti 17. dne brejosti v študiji embriofetalnega razvoja pri tej živalski vrsti) niso ugotovili učinkov na indekse plodnosti samcev ali samic ali indekse reproduktivne uspešnosti.
English: Lumacaftor/ivacaftor may decrease the exposure of hormonal contraceptives, which may reduce their efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost hormonskim kontraceptivom, kar lahko zmanjša njihovo učinkovitost.
English: Method of administration Orkambi is for oral use.
Slovenian: Zdravilo Orkambi se jemlje peroralno.
English: n = 57 95% CI: 1.2, 1.7; P < 0.0001
Slovenian: 95 % IZ: 1,2, 1,7; P < 0,0001
English: Orkambi 100 mg/125 mg film-coated tablets 3 years
Slovenian: Orkambi 100 mg/125 mg filmsko obložene tablete 3 leta
English: The steady-state exposure of ivacaftor is lower than that of Day 1 due to the CYP3A induction effect of lumacaftor (see section 4.5).
Slovenian: Izpostavljenost ivakaftorju v stanju dinamičnega ravnovesja je zaradi lumakaftorjevega učinka indukcije CYP3A manjša kot tista 1. dne
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi (see section 4.5).
Slovenian: Kadar dajemo hormonske kontraceptive, vključno s peroralnimi kontraceptivi, kontracepcijskimi injekcijami, transdermalnimi kontracepcijskimi obliži in kontracepcijskimi vsadki, se nanje ne smemo zanašati kot na učinkovito kontracepcijsko metodo, kadar jih dajemo sočasno z zdravilom Orkambi
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: Če pri svojem otroku opazite katerega koli izmed neželenih učinkov, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
English: A fat-containing meal or snack should be consumed just before or just after taking Orkambi.
Slovenian: Tik pred jemanjem zdravila Orkambi ali tik po njem zaužijte masten obrok ali prigrizek.
English: Trials in patients with CF aged 12 years and above who are homozygous for the F508del mutation in the CFTR gene
Slovenian: Preskušanja pri bolnikih s CF, starih 12 let ali več, ki so homozigotni za mutacijo F508del na genu
English: Uncommon may affect up to 1 in 100 people:
Slovenian: Občasni se lahko pojavijo pri največ 1 od 100 bolnikov:
English: NAME OF THE MEDICINAL PRODUCT Orkambi 150 mg/188 mg granules in sachet lumacaftor/ivacaftor
Slovenian: IME ZDRAVILA Orkambi 150 mg/188 mg zrnca v vrečici lumacaftorum/ivacaftorum
English: ↑ or ↓ digoxin Due to potential induction or inhibition of P-gp
Slovenian: ↑ ali ↓ dabigatran Zaradi možne indukcije ali zaviranja P-gp
English: Due to induction of CYP3A/2C19 by LUM
Slovenian: Zaradi indukcije CYP3A/2C19 z
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating treatment with lumacaftor/ivacaftor.
Slovenian: Pri pediatričnih bolnikih, ki začenjajo zdravljenje z lumakaftorjem/ivakaftorjem, priporočajo izhodiščne in kontrolne oftalmološke preiskave.
English: Abnormality of the lens of the eye (cataract) without any effect on vision has been noted in some children and adolescents treated with Orkambi and ivacaftor alone (one of the components of Orkambi).
Slovenian: Pri nekaterih otrocih in mladostnikih, zdravljenih z zdravilom Orkambi ali samo z ivakaftorjem (ena od sestavin zdravila Orkambi), so opazili motnje očesne leče (siva mrena, katarakta) brez kakega vpliva na vid.
English: Infections and infestations very common Nasopharyngitis* common
Slovenian: Infekcijske in parazitske bolezni zelo pogosti vnetje nosu in žrela*
English: Respiration abnormal, oropharyngeal pain, sinus congestion*, rhinorrhoea, pharyngeal erythema*
Slovenian: kongestija obnosnih votlin*, rinoreja, eritem žrela*
English: Patients aged 2 to 5 years and weighing 14 kg or greater lumacaftor 150 mg/ivacaftor 188 mg sachet every 12 hours
Slovenian: Bolniki, stari 2 do 5 let, s telesno maso 14 kg ali več vrečica lumakaftorja 150 mg/ivakaftorja 188 mg na 12 ur
English: At Week 24, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline in the pooled Trials 1 and 2 were 3.39 percentage points (P = 0.0382) for patients with ppFEV1 < 40 and 2.47 percentage points (P < 0.0001) for patients with ppFEV1 ≥ 40.
Slovenian: V 24. tednu je bila razlika zaradi zdravljenja med lumakaftorjem 400 mg/ivakaftorjem 250 mg na 12 ur in placebom za povprečno absolutno spremembo (95 %CI) ppFEV1 od izhodišča v združenih preskušanjih 1 in 2 3,39 odstotne točke (P = 0,0382) za bolnike s ppFEV1 < 40 in 2,47 odstotne točke (P < 0,0001) za bolnike s ppFEV1 ≥ 40.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet Orkambi 150 mg/188 mg granules in sachet
Slovenian: Orkambi 100 mg/125 mg zrnca v vrečici Orkambi 150 mg/188 mg zrnca v vrečici
English: If Orkambi is interrupted for more than one week and then re-initiated while taking strong CYP3A inhibitors, the Orkambi dose should be reduced to one tablet daily (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 6 to 11 years; lumacaftor 200 mg/ivacaftor 125 mg for patients aged 12 years and older) for the first week of treatment re-initiation.
Slovenian: Če dajanje zdravila Orkambi prekinemo za več kot en teden in ga nato spet začnemo dajati, medtem ko bolnik jemlje močne zaviralce CYP3A, moramo odmerek zdravila Orkambi zmanjšati na eno tableto na dan (lumakaftor 100 mg/ivakaftor 125 mg za bolnike, stare 6 do 11 let; lumakaftor
English: Pharmacokinetic studies have not been performed with lumacaftor/ivacaftor in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic farmakokinetičnih študij z lumakaftorjem/ivakaftorjem niso izvedli.
English: GGT ≥ 3 times the ULN or total bilirubin ≥ 2 times the ULN) were excluded.
Slovenian: > 5-kratnika ULN, ali celotni bilirubin > 2-kratnika ULN, so bili izključeni.
English: fexofenadine
Slovenian: feksofenadin
English: • Corticosteroid medicines (used to treat inflammation): methylprednisolone, prednisone
Slovenian: • kortikosteroidna zdravila (uporabljajo se za zdravljenje vnetja): metilprednizolon, prednizon;
English: It may harm them even if their signs of illness are the same as your child's.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, ki so podobni kot pri vašem otroku.
English: • If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: • Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: No dose adjustment is recommended when used with moderate or weak CYP3A inhibitors.
Slovenian: Pri uporabi z zmernimi ali šibkimi zaviralci CYP3A se prilagajanje odmerka ne priporoča.
English: What Orkambi looks like and contents of the pack Orkambi 100 mg/125 mg granules in sachet are white to off-white granules.
Slovenian: Orkambi 100 mg/125 mg zrnca v vrečici so bela do belkasta zrnca.
English: Ear pain*, ear discomfort*, tinnitus*, tympanic membrane hyperaemia*, vestibular disorder* uncommon Ear congestion*
Slovenian: Ušesne bolezni, vključno z motnjami labirinta pogosti bolečina v ušesu*, neugodje v ušesu*, tinitus*, hiperemija bobniča*, vestibularna bolezen*
English: Proportion of patients with
Slovenian: Bolniki, ki so imeli
English: During Trials 1 and 2, adverse reactions related to increased blood pressure (e.g., hypertension, blood pressure increased) were reported in 0.9% (7/738) of patients treated with lumacaftor/ivacaftor and in no patients who received placebo.
Slovenian: Zvišan krvni tlak Med preskušanjima 1 in 2 so pri 0,9 % (7/738) bolnikov, zdravljenih z lumakaftorjem/ivakaftorjem, in pri nobenem od bolnikov, ki so prejemali placebo, poročali o neželenih učinkih, povezanih z zvišanim krvnim tlakom (npr. hipertenziji, zvišanem krvnem tlaku).
English: Moderate hepatic impairment (Child-Pugh Class B)
Slovenian: Zmerna okvara jeter (razred B po
English: Lumacaftor/ivacaftor may decrease the exposures of these antidepressants, which may reduce their efficacy.
Slovenian: Lumakaftor/ivakaftor lahko zmanjša izpostavljenost tem antidepresivom, kar lahko zmanjša njihovo učinkovitost.
English: Treatment difference
Slovenian: razlika zaradi zdravljenja sprememba znotraj skupine
English: M1 and M6 are the two major metabolites of ivacaftor in humans.
Slovenian: Oba poglavitna presnovka ivakaftorja pri ljudeh sta M1 in M6.
English: • Redness inside the ear*
Slovenian: • rdečina v ušesu*,
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali s farmacevtom.