FrancophonIA/ELRC3.0 huggingface dataset:
English: The treatment difference between lumacaftor 400 mg q12h alone and placebo evaluated as mean absolute change in ppFEV1 was -4.6 percentage points (95% CI: -9.6, 0.4) from baseline to Day 28, 4.2 percentage points (95% CI: -1.3, 9.7) from baseline to Day 56, and 7.7 percentage points (95% CI: 2.6, 12.8; statistically significant) from Day 28 to Day 56 (following the addition of ivacaftor to lumacaftor monotherapy).
Slovenian: Razlika zaradi zdravljenja med lumakaftorjem 400 mg na 12 ur samim in placebom, ocenjena kot povprečna absolutna sprememba ppFEV1, je bila -4,6 odstotne točke (95 % IZ: -9,6, 0,4) od izhodišča do 28. dne, 4,2 odstotne točke (95 % IZ: -1,3, 9,7) od izhodišča do 56. dne in 7,7 odstotne točke (95 % IZ: 2,6, 12,8; statistično signifikantno) od 28. dne do 56. dne (po dodatku ivakaftorja monoterapiji z lumakaftorjem).
English: Patients with a history of colonisation with organisms such as Burkholderia cenocepacia, Burkholderia dolosa, or Mycobacterium abscessus or who had 3 or more abnormal liver function tests (ALT, AST, AP, GGT ≥ 3 times the ULN or total bilirubin ≥ 2 times the ULN) were excluded.
Slovenian: kot so Burkholderia cenocepacia, Burkholderia dolosa ali Mycobacterium abscessus, ali ki so imeli 3 ali več nenormalnih testov funkcije jeter (ALT, AST, AP, GGT ≥ 3-krat ULN ali celotni bilirubin ≥ 2krat ULN), so izključili.
English: Ivacaftor impaired fertility and reproductive performance indices in male and female rats.
Slovenian: Ivakaftor je zmanjšal indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan.
English: The most common adverse reactions experienced by patients aged 12 years and older who received lumacaftor/ivacaftor in the pooled, placebo-controlled, Phase 3 studies were dyspnoea (14.0% versus 7.8% on placebo), diarrhoea (11.0% versus 8.4% on placebo), and nausea (10.2% versus 7.6% on placebo).
Slovenian: Najpogostejši neželeni učinki pri bolnikih, starih 12 let ali več, ki so prejemali lumakaftor/ivakaftor v združenih študijah 3. faze, kontroliranih s placebom, so bili dispneja (14,0 % proti 7,8 % pri placebu), driska (11,0 % proti 8,4 % pri placebu), in navzea (10,2 % proti 7,6 % pri placebu).
English: Treatment with lumacaftor/ivacaftor significantly decreased the risk for exacerbations requiring hospitalisation versus placebo by 61% (rate ratio=0.39, P < 0.0001; event rate per 48 weeks 0.17 for lumacaftor/ivacaftor and 0.45 for placebo) and reduced exacerbations requiring treatment with intravenous antibiotics by 56% (rate ratio = 0.44, P < 0.0001; event rate per 48 weeks 0.25 for lumacaftor/ivacaftor and 0.58 for placebo).
Slovenian: Zdravljenje z lumakaftorjem/ivakaftorjem je značilno zmanjšalo tveganje poslabšanj, zaradi katerih je bila potrebna hospitalizacija, v primerjavi s placebom za 61 % (razmerje pogostnosti = 0,39, P < 0,0001; pogostnost dogodkov na 48 tednov 0,17 za lumakaftor/ivakaftor in 0,45 za placebo) in zmanjšalo poslabšanja, pri katerih je bilo potrebno zdravljenje z intravenskimi antibiotiki, za 56 % (razmerje pogostnosti = 0,44, P < 0,0001; pogostnost dogodkov na 48 tednov 0,25 za lumakaftor/ivakaftor in 0,58 za placebo).
English: A decline in ppFEV1 at initiation of therapy was observed during serial post dose spirometry assessments.
Slovenian: Med serijskim spirometričnim testiranjem po prejemu odmerka so med uvajanjem zdravljenja ugotovili zmanjšanje ppFEV1.
English: Decrease in heart rate
Slovenian: Zmanjšanje srčne frekvence
English: The exposure of lumacaftor increased approximately 2.0-fold when given with fat-containing food relative to fasted conditions.
Slovenian: Izpostavljenost lumakaftorju se je v primerjavi s stanjem na tešče zvečala približno za dvakrat, ko so ga dajali z mastno hrano.
English: Orkambi 100 mg/125 mg granules in sachet One sachet in the morning; One sachet in the evening
Slovenian: Orkambi 100 mg/125 mg zrnca v vrečici ena vrečica zjutraj; ena vrečica zvečer
English: In the pooled analysis, the rate ratio of exacerbations through week 24 in subjects treated with lumacaftor/ivacaftor (lumacaftor 400 mg/ivacaftor 250 mg q12h; n = 369) was 0.61 (P < 0.0001), representing a reduction of 39% relative to placebo.
Slovenian: V združeni analizi je bilo razmerje pogostnosti poslabšanj do 24. tedna pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem (lumakaftor 400 mg/ivakaftor 250 mg na 12 ur; n = 369) 0,61 (P < 0,0001), kar predstavlja zmanjšanje za 39 % glede na placebo.
English: In patients treated with lumacaftor/ivacaftor (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 3.1 mmHg and 1.8 mmHg, respectively.
Slovenian: Pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem (srednji izhodiščni sistolični tlak 114 mm Hg in srednji izhodiščni diastolični tlak 69 mm Hg), je bil največji porast srednjega sistoličnega in diastoličnega krvnega tlaka od izhodišča 3,1 mm Hg oziroma 1,8 mm Hg.
English: * Adverse reactions and frequencies observed in patients in clinical studies with ivacaftor monotherapy (a component of
Slovenian: *Neželeni učinki in njihova pogostnost, ki so jih ugotovili pri bolnikih v kliničnih študijah z monoterapijo z ivakaftorjem (sestavina zdravila Orkambi).
English: Patients with CF who are heterozygous for the F508del mutation in the CFTR gene Lumacaftor/ivacaftor is not effective in patients with CF who have the F508del mutation on one allele plus a second allele with a mutation predicted to result in a lack of CFTR production or that is not responsive to ivacaftor in vitro (see section 5.1).
Slovenian: Bolniki s CF, ki so heterozigotni za mutacijo F508del na genu CFTR Lumakaftor/ivakaftor ni učinkovit pri bolnikih s CF, ki imajo mutacijo F508del na enem alelu, na drugem alelu pa mutacijo, za katero je napovedano, da bo povzročila pomanjkanje izdelave CFTR, ali ki ni odzivna na ivakaftor in vitro (glejte poglavje 5.1).
English: Orkambi 150 mg/188 mg granules in sachet One sachet in the morning; One sachet in the evening
Slovenian: Orkambi 150 mg/188 mg zrnca v vrečici ena vrečica zjutraj; ena vrečica zvečer
English: It is unknown if lumacaftor or ivacaftor are found in human milk.
Slovenian: Ni znano, ali se lumakaftor ali ivakaftor izloča v materino mleko.
English: • Anticoagulants (used to prevent blood clots from forming or growing larger in blood and blood vessels) for example: warfarin, dabigatran
Slovenian: • antikoagulanti (uporabljajo se za preprečevanje nastajanja ali rasti krvnih strdkov v krvi in krvnih žilah), na primer:
English: • Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)
Slovenian: • Velikost pakiranja 56 vrečic (vsebuje 4 posamezne zloženke s po 14 vrečic na zloženko).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets EU/1/15/1059/002 56 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/001 112 filmsko obloženih tablet EU/1/15/1059/002 56 filmsko obloženih tablet
English: If your child has poor lung function your child's doctor may monitor your child more closely when she/he starts Orkambi.
Slovenian: Če ima vaš otrok slabše delovanje pljuč, ga bo zdravnik mogoče skrbneje spremljal, ko bo začel jemati zdravilo
English: The treatment difference (LS mean) in sweat chloride for the absolute change at Week 24 as compared to placebo was -24.9 mmol/L (nominal P < 0.0001).
Slovenian: kloridov v znoju za absolutno spremembo v 24. tednu v primerjavi s placebom -24,9 mmol/l (nominalna P < 0,0001).
English: No dose adjustment is recommended when used with moderate or weak CYP3A inducers.
Slovenian: Pri uporabi z zmernimi ali šibkimi induktorji CYP3A prilagajanja odmerka ne priporočajo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/003 28 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/003 28 filmsko obloženih tablet
English: See section 4.5 for interactions with immunosuppressants.
Slovenian: Glede medsebojnega delovanja z imunosupresivi glejte poglavje 4.5.
English: Absolute change from baseline in stature-for-age z-score n = 57 95% CI: 0.02, 0.15; P = 0.0104
Slovenian: Absolutna sprememba telesne višine za starost od izhodišča z-vrednost n = 57 95 % IZ: 0,02, 0,15; P = 0,0104
English: Lumacaftor/ivacaftor will decrease the exposure of these immunosuppressants, which may reduce the efficacy of these immunosuppressants.
Slovenian: Lumakaftor/ivakaftor bo zmanjšal izpostavljenost tem imunosupresivom, kar lahko zmanjša učinkovitost teh imunosupresivov.
English: After oral administration of lumacaftor 400 mg q12h/ivacaftor 250 mg q12h in a fed state, the steady-state mean (± SD) for AUC0-12h and Cmax were 198 (64.8) µg∙hr/mL and 25.0 (7.96) µg/mL for lumacaftor, respectively, and 3.66 (2.25) µg∙hr/mL and 0.602 (0.304) µg/mL for ivacaftor, respectively.
Slovenian: Po peroralnem dajanju lumakaftorja 400 mg na 12 ur/ivakaftorja 250 mg na 12 ur po obroku hrane sta bili povprečji (±SD) AUC0-12h oziroma Cmax v stanju dinamičnega ravnovesja 198 (64,8) µg∙h/ml oziroma 25,0 (7,96) µg/ml za lumakaftor in 3,66 (2,25) µg∙h/ml oziroma 0,602 (0,304) µg/ml za ivakaftor.
English: Nervous system disorders very common Headache, dizziness* uncommon Hepatic encephalopathy†
Slovenian: Bolezni živčevja zelo pogosti glavobol, omotica*
English: Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).
Slovenian: 4.1 Terapevtske indikacije Tablete zdravila Orkambi so indicirane za zdravljenje cistične fibroze (CF) pri bolnikih, starih 6 let ali več, ki so homozigotni za mutacijo F508del na genu CFTR (glejte poglavja 4.2, 4.4 in 5.1).
English: Table 2: Dose adjustment recommendations for patients with hepatic impairment Hepatic impairment
Slovenian: Preglednica 2: Priporočila za prilagoditve odmerkov pri bolnikih z okvaro jeter
English: Due to inhibition of CYP3A by clarithromycin, telithromycin
Slovenian: CYP3A s klaritromicinom, telitromicinom
English: Orkambi 200 mg/125 mg is available in the following pack sizes:
Slovenian: Zdravilo Orkambi 200 mg/125 mg je na voljo v naslednjih velikostih pakiranja:
English: Patients in both trials were randomised 1:1:1 to receive lumacaftor 600 mg once daily/ivacaftor 250 mg q12h, lumacaftor 400 mg q12h/ivacaftor 250 mg q12h, or placebo.
Slovenian: Bolniki v obeh preskušanjih so bili randomizirani v razmerju 1:1:1 na prejemanje lumakaftorja 600 mg enkrat na dan/ivakaftorja 250 mg na 12 ur, lumakaftorja 400 mg na 12 ur/ivakaftorja 250 mg na 12 ur, ali placeba.
English: During Trials 1 and 2, the incidence of combined menstrual abnormality events (amenorrhoea, dysmenorrhoea, menorrhagia, menstruation irregular, metrorrhagia, oligomenorrhoea, and polymenorrhoea) was 9.9% in lumacaftor/ivacaftor-treated female patients and 1.7% in placebo-treated females.
Slovenian: Med preskušanjima 1 in 2 je bila incidenca dogodkov združenih motenj menstrualnega ciklusa (amenoreja, dismenoreja, menoragija, neredna menstruacija, metroragija, oligomenoreja in polimenoreja) 9,9 % pri bolnicah, zdravljenih z lumakaftorjem/ivakaftorjem, in 1,7 % pri ženskah, ki so prejemale placebo.
English: Description of selected adverse reactions for patients aged 6 to 11 years Hepatobiliary events
Slovenian: Opis izbranih neželenih učinkov pri bolniki, starih 6 do 11 let Dogodki, povezani z jetri in žolčevodom
English: Benzodiazepines: midazolam, triazolam ↔ LUM, IVA
Slovenian: midazolam, triazolam ↔ LUM, IVA ↓ midazolam, triazolam
English: • Dizziness*
Slovenian: • omotica*,
English: An increase in blood pressure has been seen in some patients treated with Orkambi.
Slovenian: Pri nekaterih bolnikih, zdravljenih z zdravilom Orkambi, so ugotovili porast krvnega tlaka.
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets) 56 film-coated tablets (2 packs of 28 tablets)
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 112 filmsko obloženih tablet (4 pakiranja po 28 tablet) 56 filmsko obloženih tablet (2 pakiranji po 28 tablet)
English: 4 individual wallets with 14 sachets per wallet
Slovenian: 56 vrečic 4 posamezne zloženke s po 14 vrečicami na zloženko
English: The entire content of each sachet of granules should be mixed with one teaspoon (5 mL) of age-appropriate soft food or liquid and the mixture completely consumed.
Slovenian: Vso vsebino vsake vrečice z zrnci zmešajte z eno čajno žličko (5 ml) za starost primerne mehke hrane ali tekočine.
English: • Contraceptive medicines (used for the prevention of pregnancy): oral, injectable, and implantable contraceptives as well as contraceptive skin patches; that may include ethinyl estradiol, norethindrone, and other progestogens.
Slovenian: peroralni kontraceptivi, kontracepcijske injekcije, kontracepcijski vsadki in kontracepcijski obliži; lahko vključujejo etinil estradiol, noretindron in druge progestogene.
English: Due Date
Slovenian: DRUGI PODATKI
English: 6 years and older
Slovenian: 6 let ali več
English: Lumacaftor/ivacaftor will decrease the exposures of midazolam and triazolam, which will reduce their efficacy.
Slovenian: Lumakaftor/ivakaftor bo zmanjšal izpostavljenost midazolamu in triazolamu, kar bo zmanjšalo njuno učinkovitost.
English: Substrates of CYP3A
Slovenian: Substrati CYP3A
English: Due to induction of CYP3A by these anticonvulsants
Slovenian: Zaradi indukcije CYP3A s temi antikonvulzivi
English: Baseline ppFEV1‡ Absolute change from baseline ppFEV1 (percentage points)
Slovenian: izhodiščni ppFEV1‡ Absolutna sprememba od izhodiščnega ppFEV1 (odstotne točke)
English: However, when initiating Orkambi in patients taking strong CYP3A inhibitors, the 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 to allow for the steady state induction effect of lumacaftor.
Slovenian: Kadar pa uvajamo zdravilo Orkambi pri bolnikih, ki jemljejo močne zaviralce CYP3A, moramo odmerek zmanjšati na eno tableto na dan (lumakaftor 100 mg/ivakaftor 125 mg za bolnike, stare 6 do 11 let; lumakaftor 200 mg/ivakaftor 125 mg za bolnike, stare 12 let ali več) za prvi teden zdravljenja, da upoštevamo indukcijski učinek lumakaftorja v stanju dinamičnega ravnovesja.
English: Final CSR December 2021
Slovenian: decembra 2021.
English: Do not use this medicine after the expiry date which is stated on the carton/sachet after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli/vrečici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The treatment difference between lumacaftor 400 mg q12h alone and placebo evaluated as mean change in sweat chloride from baseline to Day 28 was statistically significant at -8.2 mmol/L (95% CI: -14, -2).
Slovenian: Razlika zaradi zdravljenja med lumakaftorjem 400 mg na 12 ur samim in placebom, ocenjena kot povprečna sprememba kloridov v znoju od izhodišča do 28. dne, je bila statistično signifikantna pri -8,2 mmol/l (95 % IZ: -14, -2).
English: # of events (rate per 48 wks)
Slovenian: # dogodkov (pogostnost na 48 tednov) razmerje pogostnosti
English: Abnormal blood tests of the liver have been commonly seen in some people receiving Orkambi.
Slovenian: Pri nekaterih ljudeh, ki so jemali zdravilo Orkambi, so pogosto ugotovili nenormalne krvne izvide jetrnih preiskav.
English: According to their weight at screening, patients were administered granules mixed with food every 12 hours, at a dose of lumacaftor 100 mg/ivacaftor 125 mg granules for patients weighing less than14 kg (n = 19) or lumacaftor 150 mg/ivacaftor 188 mg for patients weighing 14 kg or greater (n = 41), for 24 weeks in addition to their prescribed CF therapies.
Slovenian: Glede na svojo telesno maso ob presejanju so bolniki prejemali s hrano zmešana zrnca vsakih 12 ur, in sicer odmerek zrnc lumakaftorja 100 mg/ivakaftorja 125 mg za bolnike, ki so tehtali manj kot 14 kg (n = 19), ali lumakaftorja 150 mg/ivakaftorja 188 mg za bolnike, ki so tehtali 14 kg ali več (n = 41), 24 tednov poleg svojih predpisanih zdravil za CF. Za ocenjevanje učinkov brez prejemanja zdravila so prišli bolniki na varnostni kontrolni pregled po dvotedenskem obdobju izpiranja.
English: Anticoagulants: dabigatran
Slovenian: Antiaritmiki: digoksin
English: n = 35 95% CI: 22.5, 82.7; P = 0.0012
Slovenian: 95 % IZ: 22,5, 82,7; P = 0,0012
English: What Orkambi contains
Slovenian: Kaj vsebuje zdravilo Orkambi
English: n = 17 95% CI: -1.17, 0.02; P = 0.0559
Slovenian: 95 % IZ: -1,17, 0,02; P = 0,0559
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with lumacaftor/ivacaftor.
Slovenian: transdermalnimi kontracepcijskimi obliži in kontracepcijskimi vsadki, se ne smemo zanašati kot na učinkovito kontracepcijsko metodo, kadar jih dajemo sočasno z lumakaftorjem/ivakaftorjem.
English: Due to inhibition of CYP3A by fluconazole
Slovenian: Zaradi indukcije CYP3A s flukonazolom
English: Orkambi 150 mg/188 mg granules in sachet are white to off-white granules.
Slovenian: Orkambi 150 mg/188 mg zrnca v vrečici so bela do belkasta zrnca.
English: Absolute change in CFQ-R Respiratory Domain Score through Week 24 (points)
Slovenian: Absolutna sprememba rezultata respiracijske domene CFQ-R do konca 24. tedna (točke)
English: What you need to know before your child takes Orkambi Do not take Orkambi
Slovenian: Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Orkambi Otroku ne dajte zdravila Orkambi
English: What Orkambi looks like and contents of the pack Orkambi 100 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.
Slovenian: Izgled zdravila Orkambi in vsebina pakiranja Orkambi 100 mg/125 mg filmsko obložene tablete (tablete) so rožnate ovalne tablete (velikost 14 × 7,6 × 4,9 mm) z natisnjenim napisom “1V125” s črnim črnilom na eni strani.
English: • Antifungal medicines (used for the treatment of fungal infections) for example: fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
Slovenian: • protiglivična zdravila (uporabljajo se za zdravljenje glivičnih okužb), na primer: flukonazol, ketokonazol, itrakonazol, posakonazol, vorikonazol;
English: Absolute change in CFQ-R Respiratory Domain Score (points)
Slovenian: Absolutna sprememba izhodiščnega rezultata respiracijske domene CFQ-R (točke)
English: Therefore, co-administration of lumacaftor/ivacaftor is not recommended with strong CYP3A inducers (see sections 4.2 and 4.4).
Slovenian: Zato sočasno dajanje lumakaftorja/ivakaftorja z močnimi induktorji CYP3A ni priporočljivo (glejte poglavji 4.2 in 4.4).
English: Trials in patients with CF aged 6 to 11 years old who are homozygous for the F508del mutation in the CFTR gene
Slovenian: Preskušanja pri bolnikih s CF, starih 6 do 11 let, ki so homozigotni za mutacijo F508del na genu
English: Placebo transitioned to Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n = 176)**
Slovenian: Placebo, nato prehod na lumakaftor 400 mg/12 h/ ivakaftor 250 mg/12 h (n = 176)**
English: Following multiple doses of lumacaftor/ivacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had higher exposures (AUC0-12hr by approximately 50% and Cmax by approximately 30%) compared with healthy subjects matched for demographics.
Slovenian: Po večkratnih odmerkih lumakaftorja/ivakaftorja, ki so jih prejemale 10 dni, so imele osebe z zmerno okvarjeno funkcijo jeter (razred B po Child-Pughovi lestvici, rezultat 7 do 9) večje izpostavljenosti
English: The exposure of ivacaftor is similar between healthy adult volunteers and patients with CF. After twice-daily dosing, steady-state plasma concentrations of lumacaftor and ivacaftor in healthy subjects were generally reached after approximately 7 days of treatment, with an accumulation ratio of approximately 1.9 for lumacaftor.
Slovenian: Po odmerjanju dvakrat na dan so bile plazemske koncentracije lumakaftorja in ivakaftorja v stanju dinamičnega ravnovesja pri zdravih osebah na splošno dosežene po približno 7 dneh zdravljenja, razmerje kopičenja za lumakaftor je bilo približno 1,9.
English: Common may affect up to 1 in 10 people:
Slovenian: Pogosti se lahko pojavijo pri največ 1 od 10 bolnikov:
English: A higher dose of these systemic corticosteroids may be required to obtain the desired clinical effect.
Slovenian: Mogoče bo potreben večji odmerek teh sistemskih kortikosteroidov, da bomo dosegli želeni klinični učinek.
English: The treatment difference between the combination of lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo evaluated as mean change in sweat chloride from baseline to Day 56 was statistically significant at -11 mmol/L (95% CI: -18, -4).
Slovenian: Razlika zaradi zdravljenja med kombinacijo lumakaftorja 400 mg in ivakaftorja 250 mg na 12 ur in placebom, ocenjena kot povprečna sprememba kloridov v znoju od izhodišča do 56. dne, je bila statistično signifikantna pri -11 mmol/l (95 % IZ: -18, -4).
English: No meaningful changes in QTc interval or blood pressure were observed in a thorough QT clinical study evaluating either lumacaftor 600 mg once daily/ivacaftor 250 mg q12h or lumacaftor 1000 mg once daily/ivacaftor 450 mg q12h, demonstrating a lack of translation of these non-clinical findings to the clinic.
Slovenian: V temeljiti klinični študiji intervala QT, v kateri so vrednotili bodisi lumakaftor 600 mg enkrat na dan/ivakaftor 250 mg na 12 ur, bodisi lumakaftor 1000 mg enkrat na dan/ivakaftor 450 mg na 12 ur, niso ugotovili nikakršnih pomembnih sprememb intervala QTc ali krvnega tlaka, kar kaže, da teh predkliničnih ugotovitev ne moremo prenesti v kliniko.
English: The absolute change from predose at 4 to 6 hours post-dose was -7.7 on Day 1 and -1.3 on Day 15 in lumacaftor/ivacaftor patients.
Slovenian: Absolutna sprememba pri bolnikih, ki so jemali lumakaftor/ivakaftor, od časa pred odmerkom do 4 do 6 ur po odmerku je bila -7,7 1. dne in -1,3 15. dne.
English: How to store Orkambi
Slovenian: Kako dajati zdravilo Orkambi
English: Primary Endpoint through Week 24 (points)
Slovenian: 24. tedna (točke)
English: ↓ rifabutin Due to induction of CYP3A by LUM
Slovenian: ↓ rifabutin Zaradi indukcije CYP3A z LUM
English: Orkambi 200 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.
Slovenian: Orkambi 200 mg/125 mg filmsko obložene tablete (tablete) so rožnate ovalne tablete (velikost 14 × 8,4 × 6,8 mm) z natisnjenim napisom “2V125” s črnim črnilom na eni strani.
English: No dose adjustment of lumacaftor/ivacaftor is recommended when these antifungals are initiated in patients currently taking lumacaftor/ivacaftor.
Slovenian: Prilagajanja odmerka lumakaftorja/ivakaftorja ne priporočajo pri uvajanju teh antimikotikov bolnikom, ki trenutno jemljejo lumakaftor/ivakaftor.
English: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving Orkambi.
Slovenian: Pri bolnikih, ki so jemali zdravilo Orkambi, so poročali o lažno pozitivnih urinskih presejalnih testih za tetrahidrokanabinol (THC).
English: Patients aged 6 to 11 years lumacaftor 200 mg/ivacaftor 250 mg every 12 hours
Slovenian: Bolniki, stari 6 do 11 let lumakaftor 200 mg/ivakaftor 250 mg vsakih 12 ur
English: Severe hepatic impairment (Child-Pugh Class C)
Slovenian: Huda okvara jeter (razred C po
English: After oral administration of ivacaftor alone as 150 mg q12h in a fed state, the steady-state mean (± SD) for AUC0-12h and Cmax were 9.08 (3.20) µg∙hr/mL and 1.12 (0.319) µg/mL, respectively.
Slovenian: Po peroralnem dajanju ivakaftorja samega v odmerku 150 mg na 12 ur po obroku hrane sta bili povprečji (±SD) AUC0-12h oziroma Cmax v stanju dinamičnega ravnovesja 9,08 (3,20) µg∙h/ml oziroma 1,12 (0,319) µg/ml.