FrancophonIA/ELRC3.0 huggingface dataset:
English: Following resolution of transaminase elevations, the benefits and risks of resuming treatment should be considered (see section 4.8).
Slovenian: Potem ko zvišanja transaminaz izzvenijo, je treba pretehtati koristi in tveganja ponovnega začetka zdravljenja
English: Investigations
Slovenian: Analiza
English: There were 16 patients with ppFEV1 <40 at baseline receiving Symkevi, 13 receiving ivacaftor and 15 receiving placebo in Study 2.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Ear pain, Ear discomfort, Tinnitus, Tympanic membrane hyperaemia, Vestibular disorder common
Slovenian: Ušesne bolezni, vključno z motnjami labirinta bolečina v ušesih, nelagodje v ušesih, tinitus, hiperemija bobniča, vestibularna bolezen pogosti kongestija ušesa občasni
English: • Nuts, fat-containing nutritional bars or drinks
Slovenian: • orehi in lešniki, mastne prehranske ploščice in pijače.
English: • Antifungal medicines (used for the treatment of fungal infections).
Slovenian: • protiglivična zdravila (uporabljajo se za zdravljenje glivičnih okužb).
English: Table 3: Adverse reactions in patients treated with Symkevi in combination with ivacaftor MedDRA System Organ Class
Slovenian: Preglednica 3: Neželeni učinki pri bolnikih, zdravljenih z zdravilom Symkevi v kombinaciji z ivakaftorjem Organski sistem po MedDRA Neželeni učinek
English: Nasopharyngitis very common
Slovenian: nazofaringitis zelo pogosti rinitis pogosti
English: Symkevi 100 mg/150 mg film-coated tablets
Slovenian: Symkevi 100 mg/150 mg filmsko obložene tablete
English: 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.
Slovenian: M1-TEZ, M2-TEZ in M5-TEZ približno 1,5-krat večja kot za tezakaftor.
English: • rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's wort (Hypericum perforatum)
Slovenian: Primeri močnih induktorjev CYP3A vključujejo: • rifampicin, rifabutin, fenobarbital, karbamazepin, fenitoin in šentjanževko (Hypericum perforatum).
English: R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A,
Slovenian: - CFTR): P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G ali 3849+10kbC→T.
English: It is not known if Symkevi is safe and effective in children under 12.
Slovenian: Symkevi pri otrocih, mlajših od 12 let, varno in učinkovito.
English: 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.
Slovenian: AUC ivakaftorja, kadar so ga dali v kombinaciji s tezakaftorjem, se je zvečala za približno trikrat, če so ga dali z obrokom mastne hrane;
English: TEZ 100 mg qd/IVA 150 mg q12h
Slovenian: TEZ 100 mg na dan/IVA 150 mg/12 h
English: 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*).
Slovenian: 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*).
English: 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.
Slovenian: 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.
English: Examples of moderate CYP3A inhibitors include:
Slovenian: Primera zmernih zaviralcev CYP3A vključujeta:
English: Caution is recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.4 and
Slovenian: Pri bolnikih s težkimi okvarami ledvic ali končnim stadijem bolezni ledvic je priporočljiva previdnost (glejte poglavji 4.4 in 5.2).
English: CFTR activity were represented: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L,
Slovenian: 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,
English: 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.
Slovenian: 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.
English: • Feeling sick (nausea)
Slovenian: • občutek slabosti (navzea),
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Vertex Pharmaceuticals (Ireland) Limited
English: 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].
Slovenian: 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].
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Kot kaže preglednica 8, so farmakokinetični parametri tezakaftorja in ivakaftorja pri mladostnikih (12
English: Symkevi in combination with ivacaftor can make you dizzy.
Slovenian: Zdravilo Symkevi v kombinaciji z ivakaftorjem lahko povzroči omotico.
English: Ivacaftor
Slovenian: (ivacaftorum).
English: Table 4: Adverse reactions in patients treated with ivacaftor monotherapy MedDRA System Organ Class
Slovenian: Preglednica 4: Neželeni učinki pri bolnikih, zdravljenih samo z ivakaftorjem Organski sistem po MedDRA
English: 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.
Slovenian: Lahko tudi pričakujemo, da se bo izpostavljenost tezakaftorju pomembno zmanjšala med sočasno uporabo z močnimi induktorji CYP3A.
English: Tezacaftor Mean (SD)
Slovenian: n/N povprečje (SD)
English: • Stomach (abdominal) ache
Slovenian: • bolečine v trebuhu (abdomnu),
English: 4 point-increase from baseline (minimal clinically important difference) was 51.1% for Symkevi and 35.7% for placebo at Week 24.
Slovenian: 51,1 % pri zdravilu Symkevi in 35,7 % pri placebu.
English: Cloudiness of the eye lens (cataract) without any effect on vision has occurred in some children and adolescents receiving this treatment.
Slovenian: Pri nekaterih otrocih in mladostnikih, ki so prejemali to zdravljenje, se je pojavila zamegljenost očesne leče (katarakta) brez vpliva na vid.
English: CYP3A substrates
Slovenian: Zaviralci CYP3A
English: Co-administration with digoxin, a sensitive P-gp substrate, increased digoxin exposure by 1.3-fold, consistent with weak inhibition of P-gp by ivacaftor.
Slovenian: Sočasno dajanje z digoksinom, ki je občutljiv substrat P-gp, je zvečalo izpostavljenost digoksinu za
English: The dose of Symkevi should be adjusted when co-administered with strong CYP3A inhibitors (see Table 1 in section 4.2).
Slovenian: Odmerek zdravila Symkevi je treba prilagoditi, kadar ga uporabljamo skupaj z močnimi zaviralci CYP3A (glejte preglednico 1 v poglavju 4.2).
English: Evening No dose adjustment No ivacaftor 150 mg dose
Slovenian: Zvečer brez prilagoditve odmerka brez odmerka ivakaftorja 150 mg brez odmerka ivakaftorja 150 mg
English: Cmax
Slovenian: Zdravilo Cmax
English: Almac Pharma Services Ltd 20 Seagoe Industrial Estate Portadown
Slovenian: Almac Pharma Services Ltd
English: Primary ppFEV1 Baseline value
Slovenian: Primarna ppFEV1
English: In Study 3, the change in BMI z-value in the Symkevi in combination with ivacaftor group was maintained and patients previously treated with placebo showed an increase of 0.10 (0.05) kg/m2.
Slovenian: V študiji 3 se je sprememba z-vrednosti ITM v skupini z zdravilom Symkevi v kombinaciji z ivakaftorjem vzdrževala in bolniki, ki so predhodno prejemali placebo, so pokazali zvečanje za
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: Caution is recommended when administering Symkevi in combination with ivacaftor to patients with severe renal impairment or end-stage renal disease.
Slovenian: Pri dajanju zdravila Symkevi v kombinaciji z ivakaftorjem bolnikom s težkimi okvarami ledvic ali boleznijo ledvic v končnem stadiju je potrebna previdnost.
English: Placental transfer of tezacaftor was observed in pregnant rats.
Slovenian: Pri brejih podganah so ugotovili prehod tezakaftorja skozi posteljico.
English: Dizziness has been reported in patients receiving Symkevi in combination with ivacaftor, as well as ivacaftor monotherapy (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Symkevi v kombinaciji z ivakaftorjem, pa tudi pri tistih, ki so prejemali samo ivakaftor, so poročali o omotici (glejte poglavje 4.8).
English: Symkevi 100 mg/150 mg tablets tezacaftor/ivacaftor
Slovenian: Symkevi 100 mg/150 mg tablete tezacaftorum/ivacaftorum
English: Tezacaftor/ivacaftor
Slovenian: Tezakaftor/ivakaftor
English: Study in patients with CF who were homozygous for the F508del mutation in the CFTR gene (Study 1)
Slovenian: Mladostniški bolniki s CF, ki so bili homozigotni za mutacijo F508del v genu CFTR
English: Ivacaftor 150 mg tablet *Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Slovenian: Večerni odmerek ivakaftor 150 mg tableta *Nadaljujte odmerjanje tablet tezakaftorja 100 mg/ivakaftorja 150 mg ali ivakaftorja 150 mg vsak drugi dan.
English: Adolescents TEZ 100 mg qd/IVA 150 mg q12h Adults
Slovenian: Mladostniki TEZ 100 mg na dan/IVA 150 mg/12 h Odrasli
English: sex, age group (<18, >=18 years) at screening, baseline value, and baseline value-by-visit interaction as fixed effect.
Slovenian: **Model mešanih učinkov za ponovljene ukrepe, pri čemer so zdravljenje, pregled, interakcija zdravljenja s pregledom, spol, starostna skupina (< 18, > = 18 let) ob presejanju, izhodiščna vrednost in interakcija izhodiščne vrednosti s pregledom nespremenljiv učinek.
English: • Nipple changes or pain
Slovenian: • zvečanje dojk pri moških, • spremembe ali bolečine v prsnih bradavicah.
English: Following once daily dosing of tezacaftor and twice-daily dosing of ivacaftor in patients with CF, plasma concentrations of tezacaftor and ivacaftor reach steady-state within 8 days and within 3 to 5 days, respectively, after starting treatment.
Slovenian: Po odmerjanju tezakaftorja enkrat na dan in odmerjanju ivakaftorja dvakrat na dan bolnikom s CF plazemske koncentracije tezakaftorja in ivakaftorja dosežejo stanje dinamičnega ravnovesja v
English: M1-IVA and M6-IVA are the two major metabolites of ivacaftor in humans.
Slovenian: M1-IVA in M6-IVA.
English: • Blocked nose (sinus congestion)
Slovenian: • zamašen nos (kongestija obnosnih votlin), • omotica.
English: • Your doctor may do eye examinations before and during treatment with Symkevi.
Slovenian: • Pred zdravljenjem z zdravilom Symkevi in med njim vam bo zdravnik mogoče naredil očesne preiskave.
English: Relative change from baseline through Week 24
Slovenian: Absolutna sprememba ITM od izhodišča do vključno 24. tedna
English: No dose adjustment One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
Slovenian: Zjutraj brez prilagoditve odmerka ena tableta tezakaftorja 100 mg/ivakaftorja 150 mg enkrat na dan
English: 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 clearance values of tezacaftor and ivacaftor were 1.31 (0.41) and 15.7 (6.38) L/h, respectively.
Slovenian: 12 ur bolnikom s CF po obroku hrane sta bili povprečji (±SD) za vrednosti navideznega očistka tezakaftorja in ivakaftorja 1,31 (0,41) oziroma 15,7 (6,38) l/h.
English: • Ear congestion
Slovenian: • kongestija ušesa,
English: No dose adjustment is considered necessary for patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blagimi okvarami jeter prilagajanje odmerka ni potrebno.
English: − Tablet film coating: Hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), and iron oxide yellow (E172).
Slovenian: − filmska obloga tablete: hipromeloza (E464), hidroksipropilceluloza (E463), titanov dioksid
English: Abdominal pain, Diarrhoea very common
Slovenian: Bolezni prebavil bolečine v trebuhu, driska zelo pogosti
English: Baseline value
Slovenian: Izhodiščna vrednost
English: ppFEV1 Baseline value
Slovenian: ppFEV1
English: An interim analysis was conducted through Week 24
Slovenian: od izhodišča do vključno 24. tedna
English: • Redness in the throat
Slovenian: • zatrdlina v dojki.
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating treatment with Symkevi in combination with ivacaftor (see section 5.3).
Slovenian: Pri pediatričnih bolnikih, ki začenjajo zdravljenje z zdravilom Symkevi v kombinaciji z ivakaftorjem, priporočajo izhodiščne in kontrolne oftalmološke preiskave (glejte poglavje 5.3).
English: • Redness inside the ear
Slovenian: • rdečina v ušesu,
English: These include ciclosporin,
Slovenian: Vključujejo ciklosporin, takrolimus,
English: Based on these results, a modified regimen of Symkevi is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Slovenian: Na podlagi teh rezultatov je za bolnike z zmernimi okvarami jeter priporočljiva modificirana shema zdravila Symkevi
English: How to store Symkevi
Slovenian: Shranjevanje zdravila Symkevi
English: After steady-state dosing of tezacaftor in combination with ivacaftor in CF patients, the mean (SD) terminal half-lives of tezacaftor and ivacaftor were approximately 156 (52.7) and 9.3 (1.7) hours, respectively.
Slovenian: končna razpolovna časa tezakaftorja in ivakaftorja približno 156 (52,7) oziroma 9,3 (1,7) ure.
English: SN:
Slovenian: n/N
English: No dose adjustment of OATP1B1 substrates is required when coadministered with Symkevi.
Slovenian: Pri sočasnem dajanju z zdravilom Symkevi prilagajanje odmerkov substratov ATP1B1 ni potrebno.
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with Symkevi in combination with ivacaftor, as well as with ivacaftor monotherapy.
Slovenian: Pri pediatričnih bolnikih, zdravljenih z zdravilom Symkevi v kombinaciji z ivakaftorjem, pa tudi samo z ivakaftorjem, so poročali o primerih ne-prirojenih motnjav leče brez vpliva na vid.
English: Symkevi in combination with ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Slovenian: Bolniki po presaditvi organov Pri bolnikih s CF, ki so imeli presaditev organa, zdravila Symkevi v kombinaciji z ivakaftorjem niso proučevali.
English: No dose adjustment is required when Symkevi is co-administered with ciprofloxacin.
Slovenian: Pri sočasnem dajanju zdravila Symkevi in ciprofloksacina ni potrebno prilagajanje odmerjanja.
English: Upper respiratory tract infection, Nasopharyngitis very common
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje transaminaz zelo pogosti
English: Tezacaftor 100 mg/ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Slovenian: Jutranji odmerek tezakaftor 100 mg/ivakaftor 150 mg tableta ivakaftor 150 mg tableta
English: Ivacaftor 1.28 (0.440) 9.3 (1.7) *AUC0-24h for tezacaftor and AUC0-12h for ivacaftor
Slovenian: Tezakaftor 100 mg enkrat na dan/ivakaftor 150 mg vsakih 12 ur tezakaftor 6,52 (1,83) 156 ivakaftor *AUC0-24h za tezakaftor in AUC0-12h za ivakaftor
English: Adolescent patients with CF who were homozygous for the F508del mutation in the CFTR gene The mean absolute change (SE) from baseline in ppFEV1 was 3.5 (0.6) percentage points in the Symkevi in combination with ivacaftor group and -0.4 (0.6) percentage points in the placebo group in Study 1.
Slovenian: Povprečna absolutna sprememba (SE) ppFEV1 od izhodišča je bila v študiji 1 3,5 (0,6) odstotne točke v skupini z zdravilom Symkevi v kombinaciji z ivakaftorjem in -0,4 (0,6) odstotne točke v skupini, ki je prejemala placebo.
English: Oropharyngeal pain, Nasal congestion very common
Slovenian: Bolezni živčevja glavobol, omotica zelo pogosti
English: Almac Pharma Services Limited Seagoe Industrial Estate Craigavon
Slovenian: Almac Pharma Services Limited
English: Symkevi contains two active substances, tezacaftor and ivacaftor.
Slovenian: Kaj je zdravilo Symkevi in za kaj ga uporabljamo Zdravilo Symkevi vsebuje dve učinkovini, tezakaftor in ivakaftor.
English: There is no experience of the use of Symkevi in patients with severe hepatic impairment (Child-Pugh Class C); therefore, its use is not recommended unless the benefits outweigh the risks.
Slovenian: Izkušenj z uporabo zdravila Symkevi pri bolnikih s težkimi okvarami jeter (razred C po Child-Pughovi lestvici) ni.
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference versus placebo LS mean (95% CI) P value
Slovenian: sprememba znotraj skupine povprečje najmanjših kvadratov (95 % IZ) razlika zaradi zdravljenja proti placebu povprečje najmanjših kvadratov (95 % IZ) vrednost P
English: The treatment difference between Symkevi (in combination with ivacaftor) and placebo for the primary endpoint of mean absolute change (95% CI) in ppFEV1 from baseline through Week 24 was 4.0 percentage points (95% CI: 3.1, 4.8; P<0.0001).
Slovenian: (95 % IZ) ppFEV1 od izhodišča do 24. tedna je bila 4,0 odstotne točke (95 % IZ: 3,1; 4,8; P < 0,0001).
English: The most common adverse reactions experienced by patients aged 12 years and older who received Symkevi in combination with ivacaftor in the pooled, placebo-controlled, Phase 3 studies were headache (14% versus 11% on placebo) and nasopharyngitis (12% versus 10% on placebo).
Slovenian: sta bila glavobol (14 % proti 11 % pri placebu) in nazofaringitis (12 % proti 10 % pri placebu).
English: Patients who received placebo in both Study 1 and Study 2 demonstrated improvements in ppFEV1 when treated with Symkevi in combination with ivacaftor in Study 3 [Study 1: within-group change=4.2 (0.5) percentage points, Study 2: within-group change=4.9 (0.6) percentage points].
Slovenian: Bolniki, ki so tako v študiji 1 kot v študiji 2 prejemali placebo, so pokazali izboljšanje ppFEV1, ko so jih zdravili z zdravilom Symkevi v kombinaciji z ivakaftorjem v študiji 3, že 15. dne študije 3
English: No dose adjustment of CYP3A substrates is required when co-administered with Symkevi in combination with ivacaftor.
Slovenian: Pri sočasnem dajanju z zdravilom Symkevi v kombinaciji z ivakaftorjem prilagajanje odmerkov substratov CYP3A ni potrebno.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kongestija obnosnih votlin pogosti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNIH OVOJNINAH PRETISNI OMOT
English: Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
Slovenian: Navodilo za uporabo Symkevi 100 mg/150 mg filmsko obložene tablete tezakaftor (tezacaftorum)/ivakaftor (ivacaftorum)
English: Hypromellose (E464) Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Talc (E553b)
Slovenian: hidroksipropilceluloza (E463)
English: n/N Mean (SD) n/N Within-group change LS mean (95% CI) Treatment difference LS mean (95% CI) P value
Slovenian: sprememba znotraj skupine povprečje najmanjših kvadratov (95% CI) razlika zaradi zdravljenja povprečje najmanjših kvadratov (95 % IZ) vrednost P
English: • Diarrhoea
Slovenian: • nahod,
English: Drug
Slovenian: Spol
English: Hypromellose acetate succinate Sodium laurilsulfate (E487) Hypromellose (E464) Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Slovenian: mikrokristalna celuloza (E460(i)) natrijev karmelozat, premreženi (E468)
English: Package leaflet: Information for the patient Symkevi 100 mg/150 mg film-coated tablets tezacaftor/ivacaftor
Slovenian: IME ZDRAVILA Symkevi 100 mg/150 mg filmsko obložene tablete tezacaftorum/ivacaftorum
English: Important information about the contents of Symkevi
Slovenian: Kaj vsebuje zdravilo Symkevi
English: (95% CI)
Slovenian: do 96,2 %).
English: • Nausea or vomiting
Slovenian: • navzea (občutek slabosti) ali bruhanje,
English: The treatment difference between ivacaftor alone- and placebo-treated patients was 4.7 percentage points (95% CI: 3.7, 5.8; P<0.0001) and 2.1 percentage points (95% CI: 1.2, 2.9) between Symkevi in combination with ivacaftor- and ivacaftor alone-treated patients.
Slovenian: P < 0,0001), razlika med bolniki, zdravljenimi z zdravilom Symkevi v kombinaciji z ivakaftorjem, in bolniki, zdravljenimi samo z ivakaftorjem, pa 2,1 odstotne točke (95 % IZ: 1,2; 2,9).
English: The mean treatment difference between Symkevi and placebo-treated patients for absolute change in ppFEV1 through Week 24 in this subgroup was 3.5 percentage points (95% CI: 1.0, 6.1).
Slovenian: 24. tedna v tej podskupini je bila 3,5 odstotne točke (95 % IZ: 1,0; 6,1).
English: Reproductive system and breast disorders
Slovenian: Infekcijske in parazitske bolezni okužbe zgornjih dihal,
English: ** Tissue culture infectious dose 50%
Slovenian: * infektivni odmerek na tkivni kulturi 50%
English: --1 Modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50*, Modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50*.
Slovenian: modificirani živi virus bovine virusne driske tipa 2, necitopatični matični sev NY-93: