natgillin/translations-raw huggingface dataset:
The pharmacokinetic parameters of tezacaftor in combination with ivacaftor in the elderly patients (65 to 72 years) are comparable to those in younger adults.
Farmakokinetični parametri tezakaftorja v kombinaciji z ivakaftorjem pri starejših bolnikih (65 do 72 let) so primerljivi tistim pri mlajših odraslih.
±Nominal p value, based on hierarchical testing procedure.
±Nominalna vrednost p na podlagi hierarhičnega postopka testiranja.
Very limited PK data indicate comparable exposure to tezacaftor in white (n=652) and non-white (n=8) patients.
Zelo omejeni FK podatki kažejo na primerljivo izpostavljenost tezakaftorju pri belih (n = 652) in nebelih (n = 8) bolnikih.
Patients had a confirmed genotype of a protocol-specified CFTR mutation, and a confirmed diagnosis of CF.
Bolniki so imeli potrjen genotip v protokolu natančno določene mutacije CFTR in potrjeno diagnozo CF.
Tezacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Tezakaftor je približno 99-odstotno vezan na plazemske beljakovine, predvsem na albumin.
These include glimepiride and glipizide.
Vključujejo glimepirid in glipizid.
At steady-state, the accumulation ratio is approximately 2.3 for tezacaftor and 3.0 for ivacaftor.
V stanju dinamičnega ravnovesja je razmerje kopičenja približno 2,3 za tezakaftor in 3,0 za ivakaftor.
Yellow, capsule-shaped tablet debossed with “V100” on one side and plain on the other (dimensions 15.9 mm x 8.5 mm).
Rumena tableta v obliki kapsule z vtisnjenim napisom “V100” na eni strani in brez napisa na drugi strani (velikost 15,9 mm x 8,5 mm).
See Table 6 for a summary of primary and key secondary outcomes.
Glejte preglednico 6 za povzetek primarnega in ključnih sekundarnih izidov.
(may affect more than 1 in 10 people)
(lahko se pojavijo pri največ 1 od 10 bolnikov)
• Upper respiratory tract infection (the common cold), including sore throat and nasal congestion
• okužba zgornjih dihal (navadni prehlad), vključno z vnetim žrelom in kongestijo nosu,
Study 1 was a 24-week, randomized, double-blind, placebo-controlled study.
Študija 1 je bila 24-tedenska, randomizirana, dvojno slepa, s placebom kontrolirana študija.
In particular, tell your doctor if you take any of the medicines listed below.
Še posebej povejte zdravniku, če jemljete katero od zdravil, ki so našteta v nadaljevanju.
tacrolimus, sirolimus and everolimus.
sirolimus in everolimus;
The mean (SD) elimination half-lives for M1-IVA and M6-IVA were 11.3 (2.12) h and 14.4 (6.14) h, respectively.
Povprečna (SD) razpolovna časa izločanja M1-IVA in M6-IVA sta bila 11,3 (2,12) ure oziroma 14,4 (6,14) ure.
When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index, such as ciclosporin, everolimus, sirolimus, and tacrolimus, caution and appropriate monitoring should be used.
Kadar jih dajemo sočasno z digoksinom ali drugimi substrati P-gp z ozkim terapevtskim indeksom, na primer ciklosporinom, everolimusom, sirolimusom ali takrolimusom, sta potrebna previdnost in ustrezno spremljanje.
Combination repeat-dose toxicity studies in rats and dogs involving the co-administration of tezacaftor and ivacaftor to assess the potential for additive and/or synergistic toxicity did not produce any unexpected toxicities or interactions.
Kombinirane študije toksičnosti ponavljajočih se odmerkov pri podganah in psih, v katerih so sočasno dajali tezakaftor in ivakaftor, da bi ocenili možnost aditivne in/ali sinergistične toksičnosti, niso pokazale nepričakovanih toksičnosti ali interakcij.
Symkevi in combination with ivacaftor has been studied with an estrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the hormonal contraceptive.
Zdravilo Symkevi v kombinaciji z ivakaftorjem so proučevali z estrogensko/progesteronskim peroralnim kontraceptivom in ugotovili, da nima pomembnega vpliva na izpostavljenost hormonskemu kontraceptivu.
• Medicines for diabetes.
• zdravila za sladkorno bolezen.
The safety profile of Symkevi in combination with ivacaftor, including respiratory events (e.g., chest discomfort, dyspnea, and respiration abnormal), was generally similar across all subgroups of patients, including analysis by age, gender, and baseline percent predicted FEV1 (ppFEV1).
Varnostni profil zdravila Symkevi v kombinaciji z ivakaftorjem, vključno z respiracijskimi dogodki (npr. nelagodje v prsih, dispnea in nenormalno dihanje), je bil na splošno podoben pri vseh podskupinah bolnikov, vključno z analizo po starosti, spolu in izhodiščnem odstotnem deležu napovedanega FEV1 (ppFEV1).
• Yellowing of the skin or the white part of the eyes
• porumenitev kože ali beločnic,
For patients with a history of transaminase elevations, more frequent monitoring should be considered.
Pri bolnikih z zvišanjem transaminaz v anamnezi pride v poštev pogostnejše spremljanje.
M2-TEZ is much less pharmacologically active than tezacaftor or M1-TEZ, and M5-TEZ is not considered pharmacologically active.
M2-TEZ je mnogo manj farmakološko aktiven kot tezakaftor ali M1-TEZ, za M5-TEZ pa velja, da ni farmakološko aktiven.
Administration of Symkevi in combination with ivacaftor may increase systemic exposure of medicinal products that are sensitive substrates of P-gp, which may increase or prolong their therapeutic effect and adverse reactions.
Dajanje zdravila Symkevi v kombinaciji z ivakaftorjem lahko zveča sistemsko izpostavljenost zdravilom, ki so občutljivi substrati P-gp, kar lahko zveča ali podaljša njihove terapevtske učinke in neželene učinke.
• Breast-feeding: It is not known if tezacaftor or ivacaftor pass into breast milk.
• Dojenje: Ni znano, ali se tezakaftor ali ivakaftor izloča v materino mleko.
After a single dose in healthy subjects in the fed state, tezacaftor was absorbed with a median (range) time to maximum concentration (tmax) of approximately 4 hours (2 to 6 hours).
Po enkratnem odmerku pri zdravih osebah po obroku hrane se je tezakaftor absorbiral z medianim (razpon) časom do najvišje koncentracije (tmax) približno 4 ure (2 do 6 ur).
However, exposure to M2-TEZ (tezacaftor metabolite) may be increased by inhibitors of P-gp.
Izpostavljenost M2-TEZ (presnovek tezakaftorja) pa lahko zvečajo zaviralci P-gp.
For ivacaftor to function CFTR protein must be present at the cell surface.
Da lahko ivakaftor deluje, mora biti beljakovina CFTR prisotna na površini celice.
See Table 5 for a summary of primary and key secondary outcomes.
Glejte preglednico 5 za povzetek primarnih in ključnih sekundarnih izidov.
Due to its high intrinsic permeability and low likelihood of being excreted intact, co-administration of BCRP inhibitors is not expected to alter exposure of ivacaftor and M1-IVA, while any potential changes in M6-IVA exposures are not expected to be clinically relevant.
Zaradi njegove velike intrinzične permeabilnosti in majhne verjetnosti, da se bo izločil nespremenjen, ne pričakujemo, da bi sočasno dajanje zaviralcev BCRP spremenilo izpostavljenost ivakaftorju in M1-IVA, prav tako ne pričakujemo, da bi bile možne spremembe izpostavljenosti M6-IVA klinično pomembne.
As a precautionary measure, it is preferable to avoid the use of therapy during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila bolje izogibati.
Symkevi and ivacaftor are not expected to modify the efficacy of hormonal contraceptives.
Ne pričakujemo, da bosta zdravilo Symkevi in ivakaftor spremenila učinkovitost hormonskih kontraceptivov.
Avoid food or drinks containing grapefruit or Seville oranges (marmalade oranges) during treatment as these may increase the side effects of Symkevi by increasing the amount of Symkevi in your body.
Med zdravljenjem se izogibajte hrani in pijačam, ki vsebujejo grenivke ali grenke pomaranče, ker lahko zvečajo neželene učinke zdravila Symkevi, in sicer tako, da zvečajo količino zdravila Symkevi v vašem telesu.
In the pre- and post-natal study ivacaftor decreased survival and lactation indices and caused a reduction in pup body weights.
V pred- in poporodni študiji je ivakaftor zmanjšal preživetje in laktacijske indekse in povzročil zmanjšanje telesne mase mladičev.
These include telithromycin,
Vključujejo telitromicin,
Symkevi is available in the following pack size: Pack size of 28 tablets (4 blister cards, each with 7 tablets).
Zdravilo Symkevi je na voljo v naslednji velikosti pakiranja: velikost pakiranja 28 tablet (4 pretisni omoti, v vsakem je 7 tablet).
• Anticonvulsant medicines (used for the treatment of epilepsy and epileptic seizures or fits).
• antikonvulzivna zdravila (uporabljajo se za zdravljenje epilepsije in epileptičnih napadov oziroma krčev).
Open
Odpiranje
Some medicines can affect how Symkevi works or may make side effects more likely.
Nekatera zdravila lahko vplivajo na delovanje zdravila Symkevi ali pa lahko zvečajo verjetnost njegovih neželenih učinkov.
Increased liver enzymes in the blood are very common in patients with CF.
Zvišani jetrni encimi v krvi so zelo pogosti pri bolnikih s CF.
Number of subjects with events (n)/N Number of events (estimated event rate per year†) Rate ratio (RR) (95% CI) P value
število dogodkov (ocenjena pogostnost dogodkov na leto†) razmerje pogostnosti (rate ratio - RR) (95 % IZ) vrednost P
Treatment difference versus IVA LS mean
razlika zaradi zdravljenja proti IVA
The pharmacokinetics of tezacaftor and ivacaftor are similar between healthy adult volunteers and patients with CF.
Farmakokinetika tezakaftorja in ivakaftorja je pri zdravih odraslih prostovoljcih in bolnikih s CF
CFQ-R respiratory domain score
Rezultat respiracijske domene CFQ-R
These include St. John's wort (Hypericum perforatum).
Vključujejo šentjanževko (Hypericum perforatum);
Available pharmacokinetic/toxicological data in animals have shown excretion of tezacaftor and ivacaftor into the milk of lactating female rats (see section 5.3).
Razpoložljivi farmakokinetični/toksikološki podatki pri živalih kažejo na izločanje tezakaftorja in ivakaftorja v mleko doječih podganjih samic (glejte poglavje 5.3).
Co-administration with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure of ivacaftor and tezacaftor; therefore, food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.2).
Sočasna uporaba s sokom grenivke, ki vsebuje eno ali več sestavin, ki zmerno zavirajo CYP3A, lahko zveča izpostavljenost ivakaftorju in tezakaftorju; zato se je treba med zdravljenjem izogibati hrani in pijači, ki vsebujeta grenivke ali grenke pomaranče (glejte poglavje 4.2).
If 6 hours or less have passed since the missed morning or evening dose, the patient should take the missed dose as soon as possible and continue on the original schedule.
Če je od izpuščenega jutranjega ali večernega odmerka minilo največ 6 ur, naj bolnik čimprej vzame izpuščeni odmerek in nadaljuje z originalno shemo.
Pack size of 28 tablets (4 blister cards of 7 tablets each).
Velikost pakiranja po 28 tablet (4 pretisni omoti s po 7 tabletami).
• Immunosuppressants (used after an organ transplantation).
• imunosupresivi (uporabljajo se po presaditvi organov).
*Nominal p-value, based on hierarchical testing procedure.
*Nominalna vrednost p na podlagi hierarhičnega postopka testiranja.
The impact of severe hepatic impairment (Child-Pugh Class C, score 10 to 15) on the pharmacokinetics of tezacaftor and ivacaftor has not been studied.
Vpliva težke okvare jeter (razred C po Child-Pughovi lestvici, rezultat 10 do 15) na farmakokinetiko tezakaftorja in ivakaftorja niso raziskali.
Do not use this medicine after the expiry date that is stated on the package after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
In such cases, Symkevi should be used at a reduced dose (see sections 4.4 and 5.2).
V takih primerih uporabljajte zdravilo Symkevi v zmanjšanem odmerku (glejte poglavji 4.4 in 5.2).
Other fat-containing foods are:
Druge vrste mastne hrane so:
If more than 6 hours have passed since the missed morning or evening dose, the patient should not take the missed dose.
Če je od izpuščenega jutranjega ali večernega odmerka minilo več kot 6 ur, naj bolnik ne vzame izpuščenega odmerka.
Children aged less than 12 years
Otroci, mlajši od 12 let
These include ketoconazole,
Vključujejo ketokonazol,
The evening dose of ivacaftor should not be taken (see sections 4.4 and 4.5).
Večernega odmerka ivakaftorja bolnik ne sme vzeti (glejte poglavji 4.4 in 4.5).
There are no data available on the effect of tezacaftor on fertility in humans.
Podatkov o vplivu tezakaftorja na plodnost pri ljudeh ni na voljo.
• Ear pain, ear discomfort
• bolečina v ušesu, neugodje v ušesu,
The effect of the CYP3A4*22 heterozygous genotype on tezacaftor and ivacaftor exposure is consistent with the effect of co-administration of a weak CYP3A4 inhibitor, which is not clinically relevant.
Učinek heterozigotnega genotipa CYP3A4*22 na izpostavljenost tezakaftorju in ivakaftorju se sklada z učinkom sočasnega dajanja šibkega zaviralca CYP3A4, ki ni klinično pomemben.
Neither tezacaftor nor ivacaftor prolong the QTcF interval in healthy subjects at 3 times the therapeutic dose.
Niti tezakaftor niti ivakaftor pri trikratnem terapevtskem odmerku pri zdravih preiskovancih ne podaljšujeta intervala QTcF.
Co-administration with (oral) midazolam, a sensitive CYP3A substrate, did not affect midazolam exposure.
Sočasno dajanje s (peroralnim) midazolamom, ki je občutljiv substrat CYP3A, ni vplivalo na izpostavljenost midazolamu.
(mcg∙h/mL)*
(µg∙h/ml)*
Blister consisting of PCTFE (polychlorotrifluoroethylene)/PVC (polyvinyl chloride) with a paper-backed aluminum foil lidding.
Pretisni omot iz PCTFE (poliklorotrifluoroetilen)/PVC (polivinilklorid) z aluminijasto prekrivno folijo, podloženo s papirjem.
Tezacaftor and ivacaftor are substrates of CYP3A (ivacaftor is a sensitive substrate of CYP3A).
Tezakaftor in ivakaftor sta substrata CYP3A (ivakaftor je občutljiv substrat CYP3A).
Patients had a ppFEV1 at screening between 40 to 90%.
Bolniki so imeli ob presejanju ppFEV1 med 40 in 90 %.
The tablets should not be chewed, crushed, or broken before swallowing.
Preden tablete pogoltnejo, jih ne smejo žvečiti, zdrobiti ali prelomiti.
Similar trends were observed for CFQ-R respiratory domain score, pulmonary exacerbation rate and BMI.
Podobne tendence so ugotovili za rezultat respiracijske domene CFQ-R, pogostnost pljučnih eksacerbacij in ITM.
Side effects in children and adolescents are similar to those observed in adults.
Dodatni neželeni učinki pri otrocih in mladostnikih Neželeni učinki pri otrocih in mladostnikih so podobni tistim, ki so jih ugotovili pri odraslih.
• Inner ear disorder (feeling dizzy or spinning)
• bolezen notranjega ušesa (občutek omotice ali vrtenja),
Patients had a percent predicted forced expiratory volume in one second (ppFEV1) at screening between 40 to 90%.
Bolniki so imeli odstotni delež napovedanega forsiranega ekspiracijskega volumna v eni sekundi (percent predicted forced expiratory volume in one secondppFEV1) ob presejanju med 40 in 90 %.
Table 1: Dosing recommendations for concomitant use with moderate CYP3A inhibitors Day 1 Day 2 Day 3 Day 4*
Preglednica 1: Priporočila za odmerjanje pri sočasni uporabi z zmernimi zaviralci CYP3A Dan 1 Dan 2
Paediatric population The safety profile is generally consistent among adolescents and adult patients.
Varnostni profil mladostnikov in odraslih bolnikov se na splošno ujemata.
For dose adjustment for patients with hepatic impairment, see Table 2.
Za prilagoditev odmerjanja pri bolnikih z okvarami jeter glejte preglednico 2.
Subgroup analysis of patients with severe lung dysfunction (ppFEV1 <40) Study 1 and Study 2 included a total of 39 patients treated with Symkevi in combination with ivacaftor with ppFEV1 <40.
Analiza podskupine bolnikov s težko disfunkcijo pljuč (ppFEV1 < 40) V študijo 1 in študijo 2 so vključili vsega skupaj 39 bolnikov, zdravljenih z zdravilom Symkevi v kombinaciji z ivakaftorjem s ppFEV1 < 40.
In vitro studies showed that ivacaftor is not a substrate for OATP1B1, OATP1B3, or P-gp.
Študije in vitro so pokazale, da ivakaftor ni substrat OATP1B1, OATP1B3 ali P-gp.
Long-term safety and efficacy rollover study (Study 3) An ongoing, Phase 3, open-label, multicenter, rollover, 96-week study to evaluate the safety and efficacy of long-term treatment with Symkevi in combination with ivacaftor is being conducted with patients from Studies 1 (n=459) and 2 (n=226).
Dolgoročna obnovitvena študija varnosti in učinkovitosti (študija 3) Odprta multicentrična obnovitvena 96-tedenska študija 3. faze, ki še traja, za ocenjevanje varnosti in učinkovitosti dolgoročnega zdravljenja z zdravilom Symkevi v kombinaciji z ivakaftorjem poteka na bolnikih iz študij 1 (n = 459) in 2 (n = 226).
Another minor circulating metabolite, M3-TEZ, is formed by direct glucuronidation of tezacaftor.
Drugi manj pomemben presnovek v krvi, M3-TEZ, nastane z neposredno glukuronidacijo tezakaftorja.
• Talk to your doctor if you have kidney problems, or you have previously had them.
• Posvetujte se z zdravnikom, če imate težave z ledvicami ali če ste jih imeli kdaj prej.
Potential for tezacaftor/ivacaftor to interact with transporters In vitro studies showed that tezacaftor is a substrate for the uptake transporter OATP1B1, and efflux transporters P-gp and Breast Cancer Resistance Protein (BCRP).
Potencial tezakaftorja/ivakaftorja za medsebojno delovanje s prenašalci Študije in vitro so pokazale, da je tezakaftor substrat prenašalca privzema OATP1B1 (polipeptid, ki prenaša organske anione 1B1), in prenašalca iztoka P-glikoproteina (P-gp) in proteina odpornosti proti raku dojke (Breast Cancer Resistance Protein - BCRP).
The safety and efficacy of Symkevi in children aged less than 12 years has not yet been established.
Varnost in učinkovitost zdravila Symkevi pri otrocih, mlajših od 12 let, še ni bila dokazana.
It is unknown whether tezacaftor, ivacaftor, or their metabolites are excreted in human milk.
Ni znano, ali se tezakaftor, ivakaftor ali njuni presnovki izločajo v materino mleko.
If the patient's genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of an indicated mutation using a genotyping assay.
Če bolnikov genotip ni znan, je treba pred začetkom zdravljenja z natančno in validirano metodo genotipizacije potrditi prisotnost domnevne mutacije z uporabo testa genotipizacije.
for patients from Study 1 and Week 16 for patients from Study 2.
Vmesno analizo so opravili do vključno 24. tedna za bolnike iz študije 1 in do vključno 16. tedna za bolnike iz študije 2.
BMI increased in both treatment groups (Symkevi in combination with ivacaftor: 0.18 kg/m2, placebo: 0.12 kg/m2).
ITM se je zvečal v obeh zdravljenih skupinah (zdravilo Symkevi v kombinaciji z ivakaftorjem: 0,18 kg/m2, placebo: 0,12 kg/m2).
• Antibiotic medicines (used for the treatment of bacterial infections).
• antibiotična zdravila (uporabljajo se za zdravljenje bakterijskih okužb).
clarithromycin, erythromycin, rifampicin and rifabutin.
klaritromicin, eritromicin, rifampicin in rifabutin;
The efficacy of Symkevi in combination with ivacaftor 150 mg tablet in patients with CF was demonstrated in two Phase 3, double-blind, controlled studies (Study 1 and Study 2), and one Phase 3, open-label extension study (Study 3).
Učinkovitost zdravila Symkevi v kombinaciji s 150 mg tabletami ivakaftorja pri bolnikih s CF so dokazali v dveh dvojno slepih kontroliranih študijah 3. faze (študija 1 in študija 2) in eni odprti podaljšani študiji 3. faze (študija 3).
Ivacaftor was associated with slight decreases of the seminal vesicle weights, a decrease of overall fertility index and number of pregnancies in females mated with treated males and significant reductions in number of corpora lutea and implantation sites with subsequent reductions in the average litter size and average number of viable embryos per litter in treated females.
Ivakaftor je bil povezan z rahlim zmanjšanjem mase semenskih mešičkov, zmanjšanjem indeksa celotne plodnosti in števila brejosti pri samicah, ki so se parile s samci, ki so prejemali zdravilo, in s pomembnim zmanjšanjem števila rumenih telesc in ugnezditvenih mest s posledičnim zmanjšanjem povprečne velikosti legla in povprečnega števila za življenje sposobnih zarodkov na leglo pri samicah, ki so prejemale zdravilo.
These include phenobarbital, carbamazepine and phenytoin.
Vključujejo fenobarbital, karbamazepin in fenitoin;
AUCτ,ss (mcg∙h/mL)
Ivakaftor povprečje (SD) AUCτ,ss (µg∙h/ml)
No data are available for CYP3A4*22 homozygous genotype patients.
Za bolnike s homozigotnim genotipom CYP3A4*22 podatki niso na voljo.
No dose adjustment specific to this patient population is required (see section 5.2).
Prilagoditev odmerkov, ki bi bila značilna za to skupino bolnikov, ni potrebna (glejte poglavje 5.2).
Symkevi is not to be used in children under the age of 12 years.
Zdravilo Symkevi se pri otrocih, mlajših od 12 let, ne sme uporabljati.
The mean (SD) elimination half-lives for M1-TEZ, M2-TEZ and M5-TEZ were similar to that of the parent compound.
Povprečni (SD) razpolovni čas izločanja M1-TEZ, M2-TEZ in M5-TEZ je bil podoben kot pri izhodni spojini.
Both Symkevi and ivacaftor tablets should be taken with fat-containing food, such as food recommended in standard nutritional guidelines (see section 5.2).
Tako tablete zdravila Symkevi kot tablete ivakaftorja je treba jemati z mastno hrano, na primer tisto, ki jo priporočajo standardne prehranske smernice (glejte poglavje 5.2).
Laboratory abnormalities
Laboratorijske nenormalnosti
The pharmacokinetics of tezacaftor/ivacaftor in children below 12 years of age has not been investigated.
Farmakokinetike tezakaftorja/ivakaftorja pri otrocih, mlajših od 12 let, niso raziskovali.
Therefore, co-administration with strong CYP3A inducers is not recommended (see section 4.5).
Zato sočasna uporaba z močnimi induktorji CYP3A ni priporočljiva (glejte poglavje 4.5).
Medicinal products affected by tezacaftor and ivacaftor CYP2C9 substrates
Zdravila, na katera vplivata tezakaftor in ivakaftor Substrati CYP2C9
Adolescents aged 12 years and older Adolescents were included together with adults in the trials.
Mladostniki so bili v preskušanjih vključeni skupaj z odraslimi.
Co-administration of ciprofloxacin did not affect the exposure of ivacaftor or tezacaftor.
Sočasno dajanje ciprofloksacina ni vplivalo na izpostavljenost ivakaftorju ali tezakaftorju.
Co-administration of ivacaftor with rifampicin, a strong CYP3A inducer, significantly decreased ivacaftor exposure [area under the curve (AUC)] by 89%.
Sočasna uporaba ivakaftorja z rifampicinom, ki je močan induktor CYP3A, je pomembno zmanjšala izpostavljenost ivakaftorju [površina pod krivuljo (area under the curve - AUC)] za 89 %.
CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus.
CF je podedovana bolezen, pri kateri se lahko pljuča in prebavila mašijo z gosto, lepljivo sluzjo.
Symkevi taken with ivacaftor is for long-term treatment of patients aged 12 and over who have CF with certain genetic mutations that result in reduced amount and/or function of the CFTR protein.
Zdravilo Symkevi skupaj z ivakaftorjem je namenjeno za dolgoročno zdravljenje bolnikov, starih 12 let ali več, ki imajo CF z nekaterimi genetskimi mutacijami, ki povzročijo zmanjšano količino in/ali delovanje beljakovine CFTR.
Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Ivakaftor je približno 99-odstotno vezan na plazemske beljakovine, predvsem na alfa 1-kisli glikoprotein in albumin.