natgillin/translations-raw huggingface dataset:
Symkevi 100 mg tezacaftor/150 mg ivacaftor film-coated tablets are yellow, oval-shaped tablets stamped with “V100” on one side and plain on the other.
Filmsko obložene tablete Symkevi 100 mg tezakaftorja/150 mg ivakaftorja so rumene ovalne tablete z vtisnjenim napisom “V100” na eni strani in brez napisa na drugi strani.
• Herbal medicines.
• zdravila rastlinskega izvora.
In vitro data suggested that tezacaftor is metabolized mainly by CYP3A4 and CYP3A5.
Podatki in vitro so pokazali, da tezakaftor presnavljata v glavnem CYP3A4 in CYP3A5.
Exposure to tezacaftor and ivacaftor may be reduced by the concomitant use of CYP3A inducers, potentially resulting in reduced efficacy of Symkevi and ivacaftor.
Izpostavljenost tezakaftorju in ivakaftorju se lahko zmanjša s sočasno uporabo induktorjev CYP3A, kar lahko povzroči izgubo učinkovitosti zdravila Symkevi in ivakaftorja.
Study 2 was a randomized, double-blind, placebo-controlled, 2-period, 3-treatment, 8-week crossover study.
Študija 2 je bila randomizirana, dvojno slepa, s placebom kontrolirana 8-tedenska navzkrižna študija z 2 obdobjema in 3 vrstami zdravljenja.
Iron oxide yellow (E172)
titanov dioksid (E171)
Patients in Studies 1 and 2 continued on their standard-of-care CF therapies during the studies (e.g., bronchodilators, inhaled antibiotics, dornase alfa, and hypertonic saline), and were eligible to roll over into a 96-week open-label extension study (Study 3).
bronhodilatatorji, inhalacija antibiotikov, dornaza alfa in hipertonične solne raztopine) in so bili primerni za prehod v 96-tedensko odprto podaljšano študijo (študija 3).
Insert tab below to close
Zaprete tako, da vstavite noter spodnji zavihek.
Examples of strong CYP3A inducers include:
Primeri močnih zaviralcev CYP3A vključujejo:
Moderate (Child-Pugh Class B)
Zmerne (razred B po ChildPughovi lestvici)
No dose adjustment is recommended for patients with mild or moderate renal impairment.
Prilagajanje odmerkov za bolnike z blago ali zmerno okvaro ledvic ni priporočljivo.
Therefore, caution should be used when P-gp inhibitors are used with Symkevi.
Zato je pri sočasni uporabi zaviralcev P-gp in zdravila Symkevi potrebna previdnost.
Symkevi in combination with ivacaftor has been studied with pitavastatin, an OATP1B1 substrate, and was found to have no clinically relevant effect on the exposure of pitavastatin (1.24 fold increased exposure based on AUC).
OATP1B1, in ugotovili, da nima klinično pomembnega učinka na izpostavljenost pitavastatinu (1,24-krat zvečana izpostavljenost na podlagi AUC).
Transaminase elevations
Zvišanje transaminaz
How to take Symkevi
Kako jemati zdravilo Symkevi
Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W,
Zdravilo Symkevi je indicirano v kombinirani shemi s 150 mg tabletami ivakaftorja za zdravljenje bolnikov s cistično fibrozo (CF), starih 12 let ali več, ki so homozigotni za mutacijo F508del ali ki so heterozigotni za mutacijo F508del in imajo eno od naslednjih mutacij v genu regulatorju transmembranske prevodnosti pri cistični fibrozi (cystic fibrosis transmembrane conductance regulator
ppFEV1: percent predicted forced expiratory volume in 1 second; SD: Standard Deviation; LS mean: least squares mean; CI: confidence interval; NA: not applicable; IVA: ivacaftor; CFQ-R: Cystic Fibrosis Questionnaire-Revised.
ppFEV1: odstotek napovedanega forsiranega ekspiracijskega volumna v 1 sekundi; SD: standardna deviacija; IZ: interval zaupanja; NA: navedba smiselno ni potrebna; IVA: ivakaftor;
The use of Symkevi in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see Table 2 in section 4.2).
Uporaba zdravila Symkevi pri bolnikih s težkimi okvarami jeter zato ni priporočljiva, razen če koristi odtehtajo tveganja (glejte preglednico 2 v poglavju 4.2).
Key pharmacokinetic parameters for tezacaftor and ivacaftor at steady-state are shown in Table 7.
Ključne farmakokinetične parametre za tezakaftor in ivakaftor v stanju dinamičnega ravnovesja navaja preglednica 7.
No patients treated with Symkevi in combination with ivacaftor experienced a transaminase elevation >3 x ULN associated with elevated total bilirubin >2 x ULN.
Nobeden od bolnikov, zdravljenih z zdravilom Symkevi v kombinaciji z ivakaftorjem, ni imel zvišanja transaminaz > 3 x ULN,
Tezacaftor is not a substrate for OATP1B3.
Tezakaftor ni substrat OATP1B3.
Pulmonary exacerbations requiring IV antibiotic therapy were lower in the treatment group compared to placebo (RR: 0.53 [95% CI: 0.34, 0.82]; nominal P=0.0042).
Pljučnih eksacerbacij, pri katerih je bilo potrebno intravensko antibiotično zdravljenje, je bilo manj v zdravljeni skupini kot v skupini s placebom (RR: 0,53 [95 % IZ: 0,34; 0,82]; nominalna vrednost P = 0,0042).
Symkevi is normally taken with ivacaftor, another medicine.
Zdravilo Symkevi se običajno jemlje skupaj z drugim zdravilom, ivakaftorjem.
In vitro and in vivo data indicate that ivacaftor is metabolized primarily by CYP3A4 and CYP3A5.
Podatki in vitro in in vivo kažejo, da ivakaftor presnavljata predvsem CYP3A4 in CYP3A5.
Study in patients with CF who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity (Study 2)
Študija bolnikov s CF, ki so bili heterozigotni za mutacijo F508del in drugo mutacijo, povezano z rezidualno aktivnostjo CFTR (študija 2)
Table 4 reflects adverse reactions observed in clinical studies in patients treated with ivacaftor monotherapy.
Preglednica 4 kaže neželene učinke, ki so jih ugotovili v kliničnih študijah bolnikov, zdravljenih samo z ivakaftorjem.
The use of Symkevi is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Uporaba zdravila Symkevi ni priporočljiva pri bolnikih s težkimi okvarami jeter, razen če pričakujemo, da bodo koristi zdravljenja odtehtale tveganja (glejte poglavji 4.2 in 5.2).
In a combination regimen with ivacaftor 150 mg tablets The recommended dose is one Symkevi (tezacaftor 100 mg/ivacaftor 150 mg) tablet taken in the morning and one ivacaftor 150 mg tablet taken in the evening, approximately 12 hours apart with fat-containing food (see Method of administration).
Priporočeni odmerek je ena tableta zdravila Symkevi (tezakaftor 100 mg/ivakaftor 150 mg) zjutraj in ena 150-miligramska tableta ivakaftorja zvečer, približno 12 ur narazen, z mastno hrano (glejte Način uporabe).
Absolute change from baseline through Week 24 (points)**
Relativna sprememba ppFEV1 od izhodišča do vključno 24. tedna)**
Patients who were previously treated with ivacaftor and placebo and received Symkevi in combination with ivacaftor in Study 3 showed an increase of 1.6 (1.6) percentage points and 7.2 (1.2) percentage points, respectively.
Bolniki, ki so predhodno prejemali ivakaftor in placebo, v študiji 3 pa so prejemali zdravilo Symkevi v kombinaciji z ivakaftorjem, so pokazali zvečanje za 1,6 (1,6) odstotne točke oziroma 7,2 (1,2) odstotne točke.
Severe (Child-Pugh Class C)
Težke (razred C po ChildPughovi lestvici)
The European Medicines Agency has deferred the obligation to submit the results of studies with Symkevi in combination with ivacaftor in children aged less than 12 years in cystic fibrosis, as per PIP decision in the granted indication.
Symkevi v kombinaciji z ivakaftorjem za otroke, mlajše od 12 let, s cistično fibrozo, v skladu z odločbo za pediatrično populacijo (PIP) v odobreni indikaciji zdravila.
Findings of cataracts were observed in juvenile rats dosed from postnatal Day 7 through 35 at ivacaftor exposure levels of 0.25 times the MRHD based on systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor.
Katarakte so ugotavljali pri juvenilnih podganah, ki so od 7. do 35. postnatalnega dne prejemale odmerke ivakaftorja, ki so bili četrtina MHRD na podlagi sistemske izpostavljenosti ivakaftorju in njegovim presnovkom, kadar so ga dajali kot tezakaftor/ivakaftor).
The mean absolute change (SE) from baseline in ppFEV1 was 11.7 (1.2) percentage points in the Symkevi in combination with ivacaftor group, 7.6 (1.2) percentage points in the ivacaftor group and -0.4 (1.2) percentage points in the placebo group in Study 2.
Povprečna absolutna sprememba (SE) ppFEV1 od izhodišča je bila v študiji 2 11,7 (1,2) odstotne točke v skupini z zdravilom Symkevi v kombinaciji z ivakaftorjem, 7,6 (1,2) odstotne točke v skupini z ivakaftorjem in -0,4 (1,2) odstotne točke v skupini s placebom.
Each film-coated tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.
Ena filmsko obložena tableta vsebuje 100 mg tezakaftorja in 150 mg ivakaftorja.
There were 23 patients with ppFEV1 <40 at baseline receiving Symkevi and 24 patients receiving placebo in Study 1.
V študiji 1 je 23 bolnikov s ppFEV1 < 40 v izhodišču prejemalo zdravilo Symkevi, 24 bolnikov pa placebo.
Symkevi in combination with ivacaftor has a minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Symkevi v kombinaciji z ivakaftorjem ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Your doctor may change the dose of one of the medicines if you take any of these.
Če jemljete katero od teh zdravil, vam bo zdravnik mogoče spremenil odmerek tega zdravila:
Ivacaftor is also metabolized extensively in humans.
Tudi ivakaftor se pri ljudeh obsežno presnavlja.
Absolute change from baseline to the average of Week 4 and Week 8 (points)**
Absolutna sprememba od izhodišča do povprečja 4. tedna in 8. tedna
Adolescent patients with CF who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity
Mladostniški bolniki s CF, ki so bili heterozigotni za mutacijo F508del in drugo mutacijo, povezano z rezidualno aktivnostjo CFTR
In Study 2 (patients heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity), the treatment difference in mean absolute change from baseline in sweat chloride through Week 8 was -9.5 mmol/L (95% CI: -11.7, -7.3; nominal P<0.0001*) between Symkevi in combination with ivacaftor and placebo, and -4.5 mmol/L (95% CI: -6.7, -2.3; nominal P<0.0001*) between ivacaftor and placebo.
V študiji 2 (bolniki heterozigotni za mutacijo F508del in drugo mutacijo, povezano z rezidualno aktivnostjo CFTR) je bila razlika zaradi zdravljenja, izražena kot srednja absolutna sprememba kloridov v znoju od izhodišča do 8. tedna -9,5 mmol/l (95 % IZ: -11,7; -7,3; nominalna vrednost P < 0,0001*) med zdravilom Symkevi v kombinaciji z ivakaftorjem in placebom, in -4,5 mmol/l (95 % IZ: -6,7; -2,3; nominalna vrednost P < 0,0001*) med ivakaftorjem in placebom.
Co-administration of fluconazole increased ivacaftor AUC by 3-fold.
Sočasna uporaba flukonazola je zvečala AUC ivakaftorja za 3-krat.
The mean absolute change (SE) from baseline in BMI z-value was 0.24 (0.07) kg/m2 in the Symkevi in combination with ivacaftor group, 0.20 (0.07) kg/m2 in the ivacaftor group and 0.04 (0.07) kg/m2 in the placebo group in Study 2.
Povprečna absolutna sprememba (SE) z-vrednosti ITM od izhodišča v študiji 2 je bila 0,24 (0,07) kg/m2 v skupini z zdravilom Symkevi v kombinaciji z ivakaftorjem, 0,20 (0,07) kg/m2 v skupini z ivakaftorjem in 0,04 (0,07) kg/m2 v skupini s placebo.
• ketoconazole, itraconazole, posaconazole, and voriconazole
• ketokonazol, itrakonazol, posakonazol in vorikonazol; • telitromicin in klaritromicin.
Mean improvement in ppFEV1 was observed at the first assessment on Day 15 and sustained throughout the 24-week treatment period.
Povprečno izboljšanje ppFEV1 so ugotovili pri prvem ocenjevanju 15. dne in je trajalo vse
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino (učinkovine) ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
Symkevi, especially if your blood tests showed high liver enzymes in the past.
• Zdravnik bo pred zdravljenjem z zdravilom Symkevi in med njim naredil nekaj krvnih preiskav za preskus vaših jeter, zlasti, če ste v preteklosti že imeli izvide z visokimi jetrnimi encimi.
No dose adjustment is recommended for mild and moderate renal impairment.
Prilagajanje odmerka pri blagih in zmernih okvarah ledvic ni priporočljivo.
The combination targets the abnormal CFTR protein by increasing the quantity and function of CFTR at the cell surface and subsequently increasing airway surface liquid height, and ciliary beat frequency in vitro in human bronchial epithelial (HBE) cells from homozygous F508del CF patients.
Kombinacija cilja na nenormalno beljakovino CFTR, tako da zveča količino in delovanje CFTR na celični površini in nato zveča višino tekočine v zračnih potih in frekvenco utripanja migetalk in vitro v celicah človeškega bronhialnega epitelija (human bronchial epithelial - HBE) iz homozigotnih celic F508del bolnikov s CF. Natančni mehanizmi, s katerimi tezakaftor izboljša celično procesiranje in transport F508del-CFTR, ivakaftor pa ojači F508del-CFTR, niso znani.
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Neželeni učinki so navedeni po organskih sistemih MedDRA in pogostnosti: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10);
For CFQ-R respiratory domain score (a measure of respiratory symptoms relevant to patients with CF including cough, sputum production, and difficulty breathing) the percentage of subjects with at least a
Kar zadeva rezultat respiracijske domene CFQ-R (merilo respiracijskih simptomov, pomembnih za bolnike s CF, vključno s kašljem, nastajanjem izmečka in oteženim dihanjem), je bil v 24. tednu odstotni delež oseb z zvečanjem vsaj 4 točk od izhodišča (najmanjša klinično pomembna razlika)
The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through the average of Week 4 and Week 8 was 4.4 percentage points (95% CI: 1.1, 7.8).
Povprečna razlika zaradi zdravljenja med bolniki, ki so prejemali zdravilo Symkevi, in bolniki, ki so prejemali placebo, v absolutni spremembi ppFEV1 do vključno povprečja 4. tedna in 8. tedna je bila 4,4 odstotne točke (95 % IZ: 1,1; 7,8).
The mean treatment difference between ivacaftor and placebo-treated patients was 4.4 percentage points (95% CI: 0.9,
Povprečna razlika zaradi zdravljenja med bolniki, ki so se zdravili z ivakaftorjem, in bolniki, ki so prejemali placebo, je bila 4,4 odstotne točke (95 % IZ: 0,9; 7,9).
Patients who received Symkevi in combination with ivacaftor in Study 1 and Study 2, and continued on treatment, showed sustained improvements in ppFEV1 through 48 weeks (Week 24 Study 3) and through 24 weeks (Week 16 Study 3), respectively.
Bolniki, ki so prejeli zdravilo Symkevi v kombinaciji z ivakaftorjem v študiji 1 in študiji 2 in nadaljevali z zdravljenjem, so pokazali dolgotrajno izboljšanje ppFEV1 do vključno 48. tedna (v študiji 3 do vključno 24. tedna) oziroma do vključno 24. tedna (v študiji 3 do 16. tedna).
Symkevi is usually taken with ivacaftor.
Zdravilo Symkevi se običajno jemlje skupaj z ivakaftorjem.
When co-administered with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin), the dose should be adjusted to one Symkevi tablet twice a week, taken approximately 3 to 4 days apart.
itrakonazol, posakonazol, vorikonazol, telitromicin in klaritromicin), je treba odmerek prilagoditi na eno tableto zdravila Symkevi dvakrat na teden, ki jo bolnik vzame v presledku 3 do 4 dni.
In the event of significant elevations of transaminases (e.g., patients with ALT or AST >5 x the upper limit of normal (ULN), or ALT or AST >3 x ULN with bilirubin >2 x ULN), dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve.
ali ALT ali AST, > 3-krat višjo od ULN, in bilirubinom, > 2-krat višjim od ULN), je treba odmerjanje prekiniti in skrbno spremljati laboratorijske teste, dokler nenormalnosti ne izzvenijo.
Following resolution of transaminase elevations, the benefits and risks of resuming treatment should be considered (see section 4.8).
Potem ko zvišanja transaminaz izzvenijo, je treba pretehtati koristi in tveganja ponovnega začetka zdravljenja
There were 16 patients with ppFEV1 <40 at baseline receiving Symkevi, 13 receiving ivacaftor and 15 receiving placebo in Study 2.
V študiji 2 je bilo 16 bolnikov s ppFEV1 < 40 v izhodišču, ki so prejemali zdravilo Symkevi, 13 jih je prejemalo ivakaftor, 15 pa placebo.
The dose of Symkevi and ivacaftor should be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see section 4.5 and Table 1 in section 4.2).
Odmerek zdravila Symkevi in ivakaftorja je treba prilagoditi, kadar ju uporabljamo sočasno z močnimi ali zmernimi zaviralci CYP3A (glejte poglavje 4.5 in preglednico 1 v poglavju 4.2).
Ear pain, Ear discomfort, Tinnitus, Tympanic membrane hyperaemia, Vestibular disorder common
Ušesne bolezni, vključno z motnjami labirinta bolečina v ušesih, nelagodje v ušesih, tinitus, hiperemija bobniča, vestibularna bolezen pogosti kongestija ušesa občasni
• Nuts, fat-containing nutritional bars or drinks
• orehi in lešniki, mastne prehranske ploščice in pijače.
• Antifungal medicines (used for the treatment of fungal infections).
• protiglivična zdravila (uporabljajo se za zdravljenje glivičnih okužb).
Table 3: Adverse reactions in patients treated with Symkevi in combination with ivacaftor MedDRA System Organ Class
Preglednica 3: Neželeni učinki pri bolnikih, zdravljenih z zdravilom Symkevi v kombinaciji z ivakaftorjem Organski sistem po MedDRA Neželeni učinek
Nasopharyngitis very common
nazofaringitis zelo pogosti rinitis pogosti
Symkevi 100 mg/150 mg film-coated tablets
Symkevi 100 mg/150 mg filmsko obložene tablete
Under steady-state, for each of the metabolites, exposure to M1-TEZ, M2-TEZ and M5-TEZ is approximately 1.5-fold higher than for tezacaftor.
M1-TEZ, M2-TEZ in M5-TEZ približno 1,5-krat večja kot za tezakaftor.
• rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum)
Primeri močnih induktorjev CYP3A vključujejo: • rifampicin, rifabutin, fenobarbital, karbamazepin, fenitoin in šentjanževko (Hypericum perforatum).
R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A,
- CFTR): P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G ali 3849+10kbC→T.
It is not known if Symkevi is safe and effective in children under 12.
Symkevi pri otrocih, mlajših od 12 let, varno in učinkovito.
The AUC of ivacaftor when given in combination with tezacaftor increased approximately 3-fold when given with fat-containing food; therefore, Symkevi and ivacaftor should be administered with fat-containing food.
AUC ivakaftorja, kadar so ga dali v kombinaciji s tezakaftorjem, se je zvečala za približno trikrat, če so ga dali z obrokom mastne hrane;
TEZ 100 mg qd/IVA 150 mg q12h
TEZ 100 mg na dan/IVA 150 mg/12 h
In Study 1 (patients homozygous for the F508del mutation), the treatment difference between Symkevi in combination with ivacaftor and placebo in mean absolute change from baseline in sweat chloride through Week 24, was -10.1 mmol/L (95% CI: -11.4, -8.8; nominal P<0.0001*).
V študiji 1 (bolniki, homozigotni za mutacijo F508del) je bila razlika zaradi zdravljenja med zdravilom Symkevi v kombinaciji z ivakaftorjem in placebom, izražena kot srednja absolutna sprememba kloridov v znoju od izhodišča do 24. tedna -10,1 mmol/l (95 % IZ: -11,4; -8,8; nominalna vrednost P < 0,0001*).
The mean absolute change (SE) from baseline in BMI z-value was -0.01(0.05) kg/m2 in the Symkevi in combination with ivacaftor group and 0.00 (0.05) kg/m2 in the placebo group in Study 1.
Povprečna absolutna sprememba (SE) z-vrednosti ITM od izhodišča je bila -0,01(0,05) kg/m2 v skupini z zdravilom Symkevi v kombinaciji z ivakaftorjem in 0,00 (0,05) kg/m2 v skupini s placebom v študiji 1.
Examples of moderate CYP3A inhibitors include:
Primera zmernih zaviralcev CYP3A vključujeta:
Caution is recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.4 and
Pri bolnikih s težkimi okvarami ledvic ali končnim stadijem bolezni ledvic je priporočljiva previdnost (glejte poglavji 4.4 in 5.2).
CFTR activity were represented: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L,
Od 244 bolnikov, vključenih v študijo 2, so bile zastopane naslednje mutacije z indikacijo, povezane z rezidualno aktivnostjo CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L,
After oral administration of tezacaftor 100 mg once daily in combination with ivacaftor 150 mg every 12 hours in patients with CF in the fed state, the mean (±SD) for apparent volume of distribution of tezacaftor and ivacaftor was 271 (157) L and 206 (82.9) L, respectively.
Po peroralni uporabi tezakaftorja v odmerku 100 mg enkrat na dan v kombinaciji z ivakaftorjem 150 mg na 12 ur pri bolnikih s CF po obroku hrane je bilo povprečje (±SD) navideznega volumna porazdelitve tezakaftorja in ivakaftorja 271 (157) l oziroma 206 (82,9) l. Niti tezakaftor niti ivakaftor se prednostno ne porazdeljujeta v človeške rdeče krvničke.
• Feeling sick (nausea)
• občutek slabosti (navzea),
Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Vertex Pharmaceuticals (Ireland) Limited
Patients who received Symkevi in combination with ivacaftor in Study 2 and continued on treatment showed sustained improvements in ppFEV1 through 24 weeks [within-group change=0.7 (1.5) percentage points from Study 3 baseline].
Bolniki, ki so v študiji 2 prejemali zdravilo Symkevi v kombinaciji z ivakaftorjem in nadaljevali z zdravljenjem, so pokazali trajno izboljšanje ppFEV1 do vključno 24. tedna [sprememba znotraj skupine=0,7 (1,5) odstotne točke od izhodišča v študiji 3].
Caution is recommended while using Symkevi in combination with ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Pri uporabi zdravila Symkevi v kombinaciji z ivakaftorjem pri bolnikih s težkimi okvarami ledvic ali boleznijo ledvic v končnem stadiju je priporočljiva previdnost (glejte poglavji 4.2 in 5.2).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
As presented in Table 8, the pharmacokinetic parameters of tezacaftor and ivacaftor in adolescents (12 to 17 years) are comparable to those in adults when given in combination.
Kot kaže preglednica 8, so farmakokinetični parametri tezakaftorja in ivakaftorja pri mladostnikih (12
Symkevi in combination with ivacaftor can make you dizzy.
Zdravilo Symkevi v kombinaciji z ivakaftorjem lahko povzroči omotico.
Table 4: Adverse reactions in patients treated with ivacaftor monotherapy MedDRA System Organ Class
Preglednica 4: Neželeni učinki pri bolnikih, zdravljenih samo z ivakaftorjem Organski sistem po MedDRA
Tezacaftor exposures can also be expected to decrease significantly during co-administration with strong CYP3A inducers; therefore, co-administration with strong CYP3A inducers is not recommended.
Lahko tudi pričakujemo, da se bo izpostavljenost tezakaftorju pomembno zmanjšala med sočasno uporabo z močnimi induktorji CYP3A.
Tezacaftor Mean (SD)
n/N povprečje (SD)
• Stomach (abdominal) ache
• bolečine v trebuhu (abdomnu),
4 point-increase from baseline (minimal clinically important difference) was 51.1% for Symkevi and 35.7% for placebo at Week 24.
51,1 % pri zdravilu Symkevi in 35,7 % pri placebu.