FrancophonIA/ELRC3.0 huggingface dataset:
English: See the end of section 2 for important information about the contents of Symkevi.
Danish: Se til sidst i punkt 2 for vigtige oplysninger om Symkevis indhold.
English: The medicine helps lung cells to work better in some patients with cystic fibrosis (CF).
Danish: Lægemidlet hjælper lungecellerne med at virke bedre hos nogle patienter med cystisk fibrose (CF).
English: The median (range) tmax of ivacaftor was approximately 6 hours (3 to 10 hours) in the fed state.
Danish: Median (interval) tmax for ivacaftor var ca. 6 timer (3 til 10 timer) i den ikke-fastende tilstand.
English: These include glimepiride and glipizide.
Danish: Disse omfatter glimepirid og glipizid.
English: Pack size of 28 tablets (4 blister cards of 7 tablets each).
Danish: Pakningsstørrelse med 28 tabletter (4 blisterkort med 7 tabletter i hver).
English: Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Danish: Andre lægemidler, hvor eksponeringen kan være øget, omfatter glimepirid og glipizid som skal anvendes med forsigtighed.
English: CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus.
Danish: CF er en arvelig sygdom, hvor lungerne og fordøjelsessystemet kan blive fyldt med tykt, klæbrigt slim.
English: Patients had a confirmed genotype of a protocol-specified CFTR mutation, and a confirmed diagnosis of CF.
Danish: Patienterne havde en bekræftet genotype på en protokolspecificeret CFTR-mutation og en bekræftet diagnose på CF.
English: Neither tezacaftor nor ivacaftor prolong the QTcF interval in healthy subjects at 3 times the therapeutic dose.
Danish: Hverken tezacaftor eller ivacaftor forlænger QTcF-intervallet hos raske personer ved 3 gange den terapeutiske dosis.
English: See Table 6 for a summary of primary and key secondary outcomes.
Danish: Se tabel 6 for et resumé af primære og vigtigste sekundære udfald.
English: 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.
Danish: Påvirkningen af svært nedsat leverfunktion (Child-Pugh klasse C, score 10 til 15) på farmakokinetikken for tezacaftor og ivacaftor er ikke blevet undersøgt.
English: Tell your doctor right away if you have any symptoms of liver problems.
Danish: Fortæl det straks til lægen, hvis du har symptomer på leverproblemer.
English: The pharmacokinetics of tezacaftor/ivacaftor in children below 12 years of age has not been investigated.
Danish: Farmakokinetikken for tezacaftor/ivacaftor hos børn under 12 år er ikke undersøgt.
English: What you need to know before you take Symkevi 3.
Danish: Det skal du vide, før du begynder at tage Symkevi 3.
English: 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.
Danish: De gennemsnitlige (SD) eliminationshalveringstider for M1-IVA og M6-IVA var hhv. 11,3 (2,12) t og 14,4 (6,14) t.
English: *Indicates statistical significance confirmed in the hierarchical testing procedure.
Danish: *Indikerer statistisk signifikans bekræftet i den hierarkiske testprocedure.
English: Similar trends were observed for CFQ-R respiratory domain score, pulmonary exacerbation rate and BMI.
Danish: Der blev observeret tilsvarende tendenser for CFQ-R respiratorisk domænescore, lungeforværringshyppighed og BMI.
English: Symkevi is not to be used in children under the age of 12 years.
Danish: Symkevi må ikke anvendes til børn under 12 år.
English: Tezacaftor had no effects on fertility and reproductive performance indices in male and female rats at doses up to 100 mg/kg/day.
Danish: Tezacaftor havde ingen virkning på indeksværdier for fertiliteten og reproduktionsevnen hos han- og hunrotter ved doser op til 100 mg/kg/dag.
English: ** Linear Mixed Effects model with treatment, period, and study baseline ppFEV1 as fixed effects and subject as a random effect.
Danish: ** Lineær blandet virkningsmodel med behandling, periode og studie-baseline ppFEV1 som fikserede virkninger og personen som en vilkårlig virkning.
English: Race had no clinically meaningful effect on the PK of ivacaftor in white (n=379) and non-white (n=29) patients based on a population PK analysis.
Danish: Racen havde ingen klinisk betydningsfuld virkning på farmakokinetikken for ivacaftor hos hvide (n=379) og ikke-hvide (n=29) patienter baseret på en populationsfarmakokinetisk analyse.
English: 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.
Danish: På grund af den høje intrinsiske permeabilitet og en lav sandsynlighed for en intakt udskillelse forventes samtidig administration af BCRP-hæmmere ikke at ændre eksponeringen af ivacaftor og M1-IVA, mens eventuelle ændringer i M6-IVA-eksponeringer ikke forventes at være klinisk relevante.
English: There was negligible urinary excretion of ivacaftor as unchanged drug.
Danish: Der var en ubetydelig udskillelse af ivacaftor som uændret lægemiddel i urinen.
English: Patients had a ppFEV1 at screening between 40 to 90%.
Danish: Patienterne havde ppFEV1 ved screening på 40 til 90 %.
English: 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.
Danish: Ivacaftor var forbundet med små fald i seminal vesikelvægt, en reduktion i det samlede fertilitetsindeks og antallet af drægtigheder hos hunner, der blev parret med behandlede hanner og signifikante reduktioner i antallet af corpora lutea og implantationssteder med efterfølgende reduktioner i den gennemsnitlige kuldstørrelse og det gennemsnitlige antal levedygtige embryoer pr. kuld hos behandlede hunner.
English: Symkevi taken with ivacaftor helps your breathing by improving your lung function.
Danish: Symkevi, der tages sammen med ivacaftor, hjælper din vejrtrækning ved at forbedre din lungefunktion.
English: ≥3 x ULN or total bilirubin ≥2 x ULN) or AST or ALT ≥5 x ULN, were excluded from both studies.
Danish: eller totalt bilirubin ≥2 x ULN) eller ASAT eller ALAT ≥5 x ULN, blev ekskluderet fra begge studier.
English: 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.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Symkevi i kombination med ivacaftor hos børn under 12 år med cystisk fibrose, i den godkendte indikation i henhold til afgørelsen i PIP. Se pkt.
English: In the pre- and post-natal study ivacaftor decreased survival and lactation indices and caused a reduction in pup body weights.
Danish: I det præ- og postnatale studie reducerede ivacaftor overlevelses- og laktationsindekser og forårsagede en reduktion i kropsvægten af afkommet.
English: Following resolution of transaminase elevations, the benefits and risks of resuming treatment should be considered (see section 4.8).
Danish: Efter transaminaseforhøjelserne er vendt tilbage til normalen bør fordele og risici ved at genoptage behandlingen overvejes (se pkt.
English: For dose adjustment for patients with hepatic impairment, see Table 2.
Danish: For dosisjustering til patienter med nedsat leverfunktion, se tabel 2.
English: No patients treated with Symkevi in combination with ivacaftor experienced a transaminase elevation >3 x ULN associated with elevated total bilirubin >2 x ULN.
Danish: Ingen patienter i behandling med Symkevi i kombination med ivacaftor oplevede en forhøjelse af transaminaser >3 x ULN forbundet med forhøjet totalt bilirubin >2 x ULN.
English: See Table 5 for a summary of primary and key secondary outcomes.
Danish: Se tabel 5 for et resumé af primære og vigtigste sekundære udfald.
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.
Danish: Under steady-state for hver af metabolitterne er eksponeringen for M1-TEZ, M2-TEZ og M5-TEZ ca. 1,5 gange højere end for tezacaftor.
English: Clinical trials of Symkevi in combination with ivacaftor did not include patients over 75 years of age.
Danish: Kliniske studier af Symkevi i kombination med ivacaftor inkluderede ikke patienter over 75 år.
English: No dose adjustment specific to this patient population is required (see section 5.2).
Danish: En dosisjustering specifik for denne patientpopulation er ikke nødvendig (se pkt.
English: There are no data available on the effect of tezacaftor on fertility in humans.
Danish: Der foreligger ingen data for den mulige påvirkning af tezacaftor på fertiliteten hos mennesker.
English: 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).
Danish: Patienter i studie 1 og 2 fortsatte deres standardbehandling for CF i løbet af studierne (f.eks. bronkodilatatorer, inhalerede antibiotika, dornase alfa og hypertonisk saltvand) og var egnede til at overgå til et 96-ugers åbent forlængelsesstudie (studie 3).
English: These include phenobarbital, carbamazepine and phenytoin.
Danish: Disse omfatter phenobarbital, carbamazepin og phenytoin.
English: In Study 3, the change in BMI z-value in the Symkevi in combination with ivacaftor group was maintained.
Danish: I studie 3 blev ændringen BMI z-værdi i gruppen med Symkevi i kombination med ivacaftor opretholdt.
English: What you need to know before you take Symkevi Do not take Symkevi:
Danish: Det skal du vide, før du begynder at tage Symkevi Tag ikke Symkevi:
English: M6-IVA is not considered pharmacologically active.
Danish: M6-IVA anses ikke for at være farmakologisk aktiv.
English: 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.
Danish: Ved administration sammen med digoxin eller andre P-gp-substrater med et snævert terapeutisk indeks, såsom ciclosporin, everolimus, sirolimus og tacrolimus, skal der udvises forsigtighed med passende monitorering.
English: Table 2: Dosing recommendations for patients with hepatic impairment Mild (Child-Pugh Class A)
Danish: Tabel 2: Doseringsanbefalinger til patienter med nedsat leverfunktion Let (Child-Pugh klasse A)
English: Placental transfer of ivacaftor was observed in pregnant rats and rabbits.
Danish: Der blev observeret en placental overførsel af ivacaftor hos drægtige rotter og kaniner.
English: Blister consisting of PCTFE (polychlorotrifluoroethylene)/PVC (polyvinyl chloride) with a paper-backed aluminum foil lidding.
Danish: Blister bestående af PCTFE (polychlortrifluorethylen)/PVC (polyvinylchlorid) med et aluminiumsfolielag med papir på bagsiden.
English: Exposure to tezacaftor is not expected to be affected significantly by concomitant inhibitors of OATP1B1, P-gp, or BCRP due to its high intrinsic permeability and low likelihood of being excreted intact.
Danish: Eksponeringen for tezacaftor forventes ikke at påvirkes signifikant af samtidige hæmmere af OATP1B1, P-gp eller BCRP på grund af den høje intrinsiske permeabilitet og en lav sandsynlighed for en intakt udskillelse.
English: ±Nominal p value, based on hierarchical testing procedure.
Danish: ±Nominel p-værdi, baseret på en hierarkisk testprocedure.
English: 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.
Danish: Hvis der kun er gået op til 6 timer siden den glemte morgen- eller aftendosis, skal patienten tage den glemte dosis snarest muligt og fortsætte med det oprindelige program.
English: Ivacaftor causes the protein to work better while tezacaftor increases the amount of protein at the cell surface.
Danish: Ivacaftor får proteinet til at virke bedre, mens tezacaftor øger mængden af protein på celleoverfladen.
English: 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.
Danish: Undgå mad eller drikkevarer, der indeholder grapefrugt eller Sevilla-appelsiner (marmeladeappelsiner), i løbet af behandlingen, da de kan øge bivirkningerne af Symkevi ved at øge mængden af Symkevi i blodet.
English: No dose adjustment is required when Symkevi is co-administered with ciprofloxacin.
Danish: Dosisjustering er ikke nødvendig, når Symkevi administreres sammen med ciprofloxacin.
English: • Immunosuppressants (used after an organ transplantation).
Danish: • Immunsupprimerende midler (anvendes efter en organtransplantation).
English: 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.
Danish: Administration af Symkevi i kombination med ivacaftor kan øge den systemiske eksponering af lægemidler, der er følsomme P-gpsubstrater, hvilket kan øge eller forlænge den terapeutiske virkning og bivirkningerne.
English: These include telithromycin,
Danish: Disse omfatter telithromycin,
English: Tezacaftor and ivacaftor are substrates of CYP3A (ivacaftor is a sensitive substrate of CYP3A).
Danish: Tezacaftor og ivacaftor er substrater for CYP3A (ivacaftor er et følsomt substrat for CYP3A).
English: Symkevi in combination with ivacaftor has a minor influence on the ability to drive and use machines.
Danish: Symkevi i kombination med ivacaftor påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Increased liver enzymes in the blood are very common in patients with CF.
Danish: Forhøjede leverenzymer i blodet er meget almindeligt hos patienter med CF.
English: Co-administration with (oral) midazolam, a sensitive CYP3A substrate, did not affect midazolam exposure.
Danish: Administration sammen med (oralt) midazolam, et følsomt CYP3A-substrat, påvirkede ikke eksponeringen af midazolam.
English: Take the tablets with fat-containing food.
Danish: Tag tabletterne med fedtholdig mad.
English: No data are available for CYP3A4*22 homozygous genotype patients.
Danish: Der forefindes ingen data for patienter med homozygot CYP3A4*22-genotype.
English: Tezacaftor is not a substrate for OATP1B3.
Danish: Tezacaftor er ikke et substrat for OATP1B3.
English: Medicinal products affected by tezacaftor and ivacaftor CYP2C9 substrates
Danish: Lægemidler, der påvirkes af tezacaftor og ivacaftor CYP2C9-substrater
English: Symkevi is normally taken with ivacaftor, another medicine.
Danish: Symkevi tages normalt med ivacaftor, et andet lægemiddel.
English: The AUC of tezacaftor did not change when given with fat-containing food relative to fasted conditions.
Danish: AUC for tezacaftor var ikke ændret ved indtagelse sammen med fedtholdig mad sammenlignet med fastende tilstande.
English: If more than 6 hours have passed since the missed morning or evening dose, the patient should not take the missed dose.
Danish: Hvis der er gået over 6 timer siden den glemte morgen- eller aftendosis, skal patienten ikke tage den glemte dosis.
English: CYP3A, digoxin and other P-gp Substrates
Danish: CYP3A, digoxin og andre P-gp-substrater
English: 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).
Danish: Efter en enkelt dosis til raske personer, som havde indtaget mad, blev tezacaftor absorberet med en mediantid (interval) til maksimal koncentration (tmax) på ca. 4 timer (2 til 6 timer).
English: Symkevi works on a protein called CFTR (cystic fibrosis transmembrane conductance regulator), which is damaged in some people with CF (who have a mutation in the CFTR gene).
Danish: Symkevi virker på et protein kaldet CFTR (cystisk fibrose transmembran konduktansregulator), som er beskadiget hos nogle personer med CF (der har en mutation i CFTR-genet).
English: The safety, efficacy and pharmacokinetics of Symkevi in combination with ivacaftor have been examined in a limited number of elderly patients.
Danish: Symkevis sikkerhed, virkning og farmakokinetik i kombination med ivacaftor er blevet undersøgt hos et begrænset antal ældre patienter.
English: (mcg/mL)
Danish: (µg/ml)
English: Following oral administration of 14C-tezacaftor, the majority of the dose (72%) was excreted in the faeces (unchanged or as the M2-TEZ metabolite) and about 14% was recovered in urine (mostly as M2-TEZ metabolite), resulting in a mean overall recovery of 86% up to 21 days after the dose.
Danish: Efter oral administration af 14C-tezacaftor blev størstedelen af dosen (72 %) elimineret i fæces (uændret eller som M2-TEZ-metabolitten) og ca. 14 % blev genfundet i urinen (primært som M2-TEZ-metabolitten), hvilket fører til en gennemsnitlig samlet genfinding af 86 % op til 21 dage efter dosis.
English: Abdominal pain, Diarrhoea very common
Danish: Abdominalsmerter, diarré meget almindelig
English: 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.
Danish: I tilfælde af en signifikant forhøjelse af transaminaser (f.eks. patienter med ALAT eller ASAT >5 x den øvre normalgrænse (ULN) eller ALAT eller ASAT >3 x ULN med bilirubin >2 x ULN) bør doseringen seponeres, og laboratorieprøver skal følges nøje, indtil anormaliteterne har fortaget sig.
English: Effects on sweat chloride
Danish: Virkning på svedchlorid
English: These include St. John's wort (Hypericum perforatum).
Danish: Disse omfatter prikbladet perikon (Hypericum perforatum).
English: Symkevi is available in the following pack size: Pack size of 28 tablets (4 blister cards, each with 7 tablets).
Danish: Symkevi fås i følgende pakningsstørrelser: Pakningsstørrelse på 28 tabletter (4 blisterkort, hver med 7 tabletter).
English: 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).
Danish: Sikkerhedsprofilen for Symkevi i kombination med ivacaftor, herunder luftvejshændelser (f.eks. brystgener, dyspnø og unormal vejrtrækning), var generelt ens for alle patientundergrupper,-inklusiv analyse efter alder, køn og procent forventet FEV1 (ppFEV1) ved baseline.
English: • Anticonvulsant medicines (used for the treatment of epilepsy and epileptic seizures or fits).
Danish: • Antikonvulsiva (anvendes til behandling af epilepsi og epileptiske anfald eller krampeanfald).
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Danish: Ivacaftor er ca. 99 % bundet til plasmaproteiner, primært til alfa-1-syre-glykoprotein og albumin.
English: • Breast-feeding: It is not known if tezacaftor or ivacaftor pass into breast milk.
Danish: • Amning: Det er ukendt, om tezacaftor eller ivacaftor udskilles i brystmælk.
English: • ketoconazole, itraconazole, posaconazole, and voriconazole
Danish: • ketoconazol, itraconazol, posaconazol og voriconazol
English: Symkevi in combination with ivacaftor can make you dizzy.
Danish: Symkevi i kombination med ivacaftor kan gøre dig svimmel.
English: • Nipple changes or pain
Danish: • ændringer eller smerter i brystvorter
English: 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).
Danish: Mulighed for, at tezacaftor/ivacaftor påvirker transportere In vitro-studier viste, at tezacaftor er et substrat for den organiske aniontransporter OATP1B1 og efflukstransporterne P-gp og brystcancerresistensprotein (BCRP).
English: 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.
Danish: Ved administration sammen med potente CYP3A-hæmmere (f.eks. ketoconazol, itraconazol, posaconazol, voriconazol, telithromycin og clarithromycin) skal dosis justeres til én tablet med Symkevi to gange ugentligt med ca. 3-4 dages mellemrum.
English: Table 5: Primary and key secondary efficacy analyses, full analysis set (Study 1) Analysis
Danish: Tabel 5: Primære og vigtigste sekundære virkningsanalyser, fuldstændigt analysesæt (studie 1)
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.
Danish: Der er ingen erfaring med anvendelsen af Symkevi til patienter med svært nedsat leverfunktion (Child-Pugh klasse C) og bør derfor ikke anvendes, medmindre fordelene opvejer risiciene.
English: Ivacaftor is also metabolized extensively in humans.
Danish: Ivacaftor metaboliseres også i udtalt grad hos mennesker.
English: Symkevi in combination with ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Danish: Symkevi i kombination med ivacaftor er ikke blevet undersøgt hos patienter med CF, som har gennemgået organtransplantation.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: 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.
Danish: Virkningen af den heterozygote CYP3A4*22-genotype på tezacaftor- og ivacaftor-eksponering er sammenlignelig med virkningen af administration sammen med en svag CYP3A4-hæmmer, som ikke er klinisk relevant.
English: The exact mechanisms by which tezacaftor improves cellular processing and trafficking of F508del-CFTR and ivacaftor potentiates F508del-CFTR are not known.
Danish: Den præcise mekanisme hvorved tezacaftor forbedrer den cellulære behandling og transporten af F508del-CFTR, og ivacaftor potenserer F508del-CFTR er ukendt.
English: Number of subjects with events (n)/N Number of events (estimated event rate per year†) Rate ratio (RR) (95% CI) P value
Danish: Antal personer med hændelser (n)/N Antal hændelser (estimeret hyppighed af hændelser pr. år†) Hyppighedsratio (RR) (95 % CI) P værdi
English: The pharmacokinetic parameters of tezacaftor in combination with ivacaftor in the elderly patients (65 to 72 years) are comparable to those in younger adults.
Danish: De farmakokinetiske parametre for tezacaftor i kombination med ivacaftor hos ældre patienter (65 til 72 år) er sammenlignelige med parametrene for yngre voksne.
English: (mcg∙h/mL)*
Danish: (µg∙t/ml)*
English: Side effects seen with ivacaftor: Very common side effects
Danish: Bivirkninger observeret med ivacaftor: Meget almindelige bivirkninger