natgillin/translations-raw huggingface dataset:
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).
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).
Orkambi 150 mg/188 mg granules in sachet One sachet in the morning; One sachet in the evening
Orkambi 150 mg/188 mg zrnca v vrečici ena vrečica zjutraj; ena vrečica zvečer
It is unknown if lumacaftor or ivacaftor are found in human milk.
Ni znano, ali se lumakaftor ali ivakaftor izloča v materino mleko.
• Anticoagulants (used to prevent blood clots from forming or growing larger in blood and blood vessels) for example: warfarin, dabigatran
• antikoagulanti (uporabljajo se za preprečevanje nastajanja ali rasti krvnih strdkov v krvi in krvnih žilah), na primer:
• Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)
• Velikost pakiranja 56 vrečic (vsebuje 4 posamezne zloženke s po 14 vrečic na zloženko).
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets EU/1/15/1059/002 56 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/001 112 filmsko obloženih tablet EU/1/15/1059/002 56 filmsko obloženih tablet
If your child has poor lung function your child's doctor may monitor your child more closely when she/he starts Orkambi.
Če ima vaš otrok slabše delovanje pljuč, ga bo zdravnik mogoče skrbneje spremljal, ko bo začel jemati zdravilo
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).
kloridov v znoju za absolutno spremembo v 24. tednu v primerjavi s placebom -24,9 mmol/l (nominalna P < 0,0001).
No dose adjustment is recommended when used with moderate or weak CYP3A inducers.
Pri uporabi z zmernimi ali šibkimi induktorji CYP3A prilagajanja odmerka ne priporočajo.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/003 28 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1059/003 28 filmsko obloženih tablet
See section 4.5 for interactions with immunosuppressants.
Glede medsebojnega delovanja z imunosupresivi glejte poglavje 4.5.
Absolute change from baseline in stature-for-age z-score n = 57 95% CI: 0.02, 0.15; P = 0.0104
Absolutna sprememba telesne višine za starost od izhodišča z-vrednost n = 57 95 % IZ: 0,02, 0,15; P = 0,0104
Lumacaftor/ivacaftor will decrease the exposure of these immunosuppressants, which may reduce the efficacy of these immunosuppressants.
Lumakaftor/ivakaftor bo zmanjšal izpostavljenost tem imunosupresivom, kar lahko zmanjša učinkovitost teh imunosupresivov.
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.
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.
Nervous system disorders very common Headache, dizziness* uncommon Hepatic encephalopathy†
Bolezni živčevja zelo pogosti glavobol, omotica*
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).
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).
Table 2: Dose adjustment recommendations for patients with hepatic impairment Hepatic impairment
Preglednica 2: Priporočila za prilagoditve odmerkov pri bolnikih z okvaro jeter
Due to inhibition of CYP3A by clarithromycin, telithromycin
CYP3A s klaritromicinom, telitromicinom
Orkambi 200 mg/125 mg is available in the following pack sizes:
Zdravilo Orkambi 200 mg/125 mg je na voljo v naslednjih velikostih pakiranja:
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.
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.
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.
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.
Description of selected adverse reactions for patients aged 6 to 11 years Hepatobiliary events
Opis izbranih neželenih učinkov pri bolniki, starih 6 do 11 let Dogodki, povezani z jetri in žolčevodom
Benzodiazepines: midazolam, triazolam ↔ LUM, IVA
midazolam, triazolam ↔ LUM, IVA ↓ midazolam, triazolam
• Dizziness*
• omotica*,
An increase in blood pressure has been seen in some patients treated with Orkambi.
Pri nekaterih bolnikih, zdravljenih z zdravilom Orkambi, so ugotovili porast krvnega tlaka.
PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets) 56 film-coated tablets (2 packs of 28 tablets)
FARMACEVTSKA OBLIKA IN VSEBINA 112 filmsko obloženih tablet (4 pakiranja po 28 tablet) 56 filmsko obloženih tablet (2 pakiranji po 28 tablet)
4 individual wallets with 14 sachets per wallet
56 vrečic 4 posamezne zloženke s po 14 vrečicami na zloženko
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.
Vso vsebino vsake vrečice z zrnci zmešajte z eno čajno žličko (5 ml) za starost primerne mehke hrane ali tekočine.
• 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.
peroralni kontraceptivi, kontracepcijske injekcije, kontracepcijski vsadki in kontracepcijski obliži; lahko vključujejo etinil estradiol, noretindron in druge progestogene.
Due Date
DRUGI PODATKI
6 years and older
6 let ali več
Lumacaftor/ivacaftor will decrease the exposures of midazolam and triazolam, which will reduce their efficacy.
Lumakaftor/ivakaftor bo zmanjšal izpostavljenost midazolamu in triazolamu, kar bo zmanjšalo njuno učinkovitost.
Substrates of CYP3A
Substrati CYP3A
Due to induction of CYP3A by these anticonvulsants
Zaradi indukcije CYP3A s temi antikonvulzivi
Baseline ppFEV1‡ Absolute change from baseline ppFEV1 (percentage points)
izhodiščni ppFEV1‡ Absolutna sprememba od izhodiščnega ppFEV1 (odstotne točke)
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.
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.
Final CSR December 2021
decembra 2021.
Do not use this medicine after the expiry date which is stated on the carton/sachet after EXP.
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.
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).
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).
# of events (rate per 48 wks)
# dogodkov (pogostnost na 48 tednov) razmerje pogostnosti
Abnormal blood tests of the liver have been commonly seen in some people receiving Orkambi.
Pri nekaterih ljudeh, ki so jemali zdravilo Orkambi, so pogosto ugotovili nenormalne krvne izvide jetrnih preiskav.
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.
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.
Anticoagulants: dabigatran
Antiaritmiki: digoksin
n = 35 95% CI: 22.5, 82.7; P = 0.0012
95 % IZ: 22,5, 82,7; P = 0,0012
What Orkambi contains
Kaj vsebuje zdravilo Orkambi
n = 17 95% CI: -1.17, 0.02; P = 0.0559
95 % IZ: -1,17, 0,02; P = 0,0559
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.
transdermalnimi kontracepcijskimi obliži in kontracepcijskimi vsadki, se ne smemo zanašati kot na učinkovito kontracepcijsko metodo, kadar jih dajemo sočasno z lumakaftorjem/ivakaftorjem.
Due to inhibition of CYP3A by fluconazole
Zaradi indukcije CYP3A s flukonazolom
Orkambi 150 mg/188 mg granules in sachet are white to off-white granules.
Orkambi 150 mg/188 mg zrnca v vrečici so bela do belkasta zrnca.
Absolute change in CFQ-R Respiratory Domain Score through Week 24 (points)
Absolutna sprememba rezultata respiracijske domene CFQ-R do konca 24. tedna (točke)
What you need to know before your child takes Orkambi Do not take Orkambi
Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Orkambi Otroku ne dajte zdravila Orkambi
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.
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.
• Antifungal medicines (used for the treatment of fungal infections) for example: fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
• protiglivična zdravila (uporabljajo se za zdravljenje glivičnih okužb), na primer: flukonazol, ketokonazol, itrakonazol, posakonazol, vorikonazol;
Absolute change in CFQ-R Respiratory Domain Score (points)
Absolutna sprememba izhodiščnega rezultata respiracijske domene CFQ-R (točke)
Therefore, co-administration of lumacaftor/ivacaftor is not recommended with strong CYP3A inducers (see sections 4.2 and 4.4).
Zato sočasno dajanje lumakaftorja/ivakaftorja z močnimi induktorji CYP3A ni priporočljivo (glejte poglavji 4.2 in 4.4).
Trials in patients with CF aged 6 to 11 years old who are homozygous for the F508del mutation in the CFTR gene
Preskušanja pri bolnikih s CF, starih 6 do 11 let, ki so homozigotni za mutacijo F508del na genu
Placebo transitioned to Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n = 176)**
Placebo, nato prehod na lumakaftor 400 mg/12 h/ ivakaftor 250 mg/12 h (n = 176)**
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.
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
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.
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.
Common may affect up to 1 in 10 people:
Pogosti se lahko pojavijo pri največ 1 od 10 bolnikov:
A higher dose of these systemic corticosteroids may be required to obtain the desired clinical effect.
Mogoče bo potreben večji odmerek teh sistemskih kortikosteroidov, da bomo dosegli želeni klinični učinek.
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).
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).
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.
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.
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.
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.
How to store Orkambi
Kako dajati zdravilo Orkambi
Primary Endpoint through Week 24 (points)
24. tedna (točke)
↓ rifabutin Due to induction of CYP3A by LUM
↓ rifabutin Zaradi indukcije CYP3A z LUM
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.
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.
No dose adjustment of lumacaftor/ivacaftor is recommended when these antifungals are initiated in patients currently taking lumacaftor/ivacaftor.
Prilagajanja odmerka lumakaftorja/ivakaftorja ne priporočajo pri uvajanju teh antimikotikov bolnikom, ki trenutno jemljejo lumakaftor/ivakaftor.
There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving Orkambi.
Pri bolnikih, ki so jemali zdravilo Orkambi, so poročali o lažno pozitivnih urinskih presejalnih testih za tetrahidrokanabinol (THC).
Patients aged 6 to 11 years lumacaftor 200 mg/ivacaftor 250 mg every 12 hours
Bolniki, stari 6 do 11 let lumakaftor 200 mg/ivakaftor 250 mg vsakih 12 ur
Severe hepatic impairment (Child-Pugh Class C)
Huda okvara jeter (razred C po
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.
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.
Presentation of the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h dose group is consistent with recommended posology.
Rezultati skupine z odmerkom lumakaftorja 400 mg/12 h/ivakaftorja 250 mg/12 h so skladni s priporočenim odmerjanjem.
Due to induction of CYP3A by LUM
Zaradi indukcije CYP3A z LUM
The primary efficacy endpoint was absolute change in LCI2.5 from baseline through Week 24.
Primarni učinkovitostni cilj študije je bila absolutna sprememba LCI2,5 od izhodišča do 24. tedna.
Always give your child this medicine exactly as your child's doctor has told you.
Pri dajanju tega zdravila svojemu otroku natančno upoštevajte navodila otrokovega zdravnika.
Component of a multipack, cannot be sold separately
Prodaja posamezne enote ni možna.
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.
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.
↔ LUM
z LUM
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.
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.
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.
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.
The international normalised ratio (INR) should be monitored when warfarin co-administration with lumacaftor/ivacaftor is required.
Kadar je potrebna sočasna uporaba varfarina z lumakaftorjem/ivakaftorjem, je treba spremljati mednarodno normalizirano razmerje (INR-international normalised ratio).
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]).
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]).
Anticonvulsants: carbamazepine, phenobarbital, phenytoin
karbamazepin, fenobarbital, fenitoin
No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with fluconazole.
Prilagajanja odmerka lumakaftorja/ivakaftorja ne priporočajo, kadar se uporablja sočasno s flukonazolom.
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).
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 %
Tell your child's doctor straight away if he/she gets any of these:
Nemudoma obvestite otrokovega zdravnika, če se pri otroku pojavi:
No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with erythromycin.
Prilagajanja odmerka lumakaftorja/ivakaftorja ne priporočajo, kadar se uporablja sočasno z eritromicinom.
n = 57 95% CI: 0.07, 0.47; P = 0.0091
95 % IZ: 0,07, 0,47; P = 0,0091
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.
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.
What you need to know before you take Orkambi Do not take Orkambi
Kaj morate vedeti, preden boste vzeli zdravilo Orkambi Ne jemljite zdravila Orkambi
Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
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.
A population pharmacokinetic analysis of clearance versus creatinine clearance shows no trend for subjects with mild and moderate renal impairment (see section 4.2).
Populacijska farmakokinetična analiza očistka proti očistku kreatinina pri bolnikih z blago in zmerno okvaro ledvic ni pokazala trenda
Therefore, lumacaftor/ivacaftor should be administered with fat-containing food.
Zato je treba dajati lumakaftor/ivakaftor z mastno hrano.
A higher dose of these antidepressants may be required to obtain the desired clinical effect.
Mogoče bo potreben večji odmerek teh antidepresivov, da bomo dosegli želeni klinični učinek.
Ivacaftor, which is one of the active components of Orkambi, has a minor influence on the ability to drive or use machines.
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.
Do not take a double dose to make up for the forgotten tablets.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.