FrancophonIA/ELRC3.0 huggingface dataset:
English: Your child's doctor will do some blood tests to check your child's liver before and during treatment, particularly during the first year and especially if blood tests showed high liver enzymes in the past.
Danish: • mørk urin Dit barns læge vil tage nogle blodprøver for at kontrollere dit barns lever før og under behandlingen, især i løbet af det første år, og især hvis dits barns blodprøver tidligere har vist høje leverenzymer.
English: A single ivacaftor-treated patient (2.5%) in this age range had an elevation of ALT and AST > 8 x ULN.
Danish: En enkelt ivacaftorbehandlet patient (2,5 %) i denne aldersgruppe havde en stigning i ALAT og ASAT >8 x ULN.
English: The observed treatment difference (95% CI) between ivacaftor and placebo was 10.7% (7.3, 14.1) (P < 0.0001).
Danish: Den observerede behandlingsforskel (95 % CI) mellem ivacaftor og placebo var 10,7 % (7,3; 14,1) (p <0,0001).
English: If you forget to give your child Kalydeco
Danish: Hvis du har glemt at give dit barn Kalydeco
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: At week 24 At week 48
Danish: Ved uge 24 Ved uge 48
English: Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell.
Danish: Ivacaftor hjælper visse unormale CFTR-proteiner med at åbne kanalerne hyppigere, så chlorid nemmere kan føres ind og ud af cellen.
English: There is no experience of the use of Kalydeco in patients with severe hepatic impairment; therefore, its use is not recommended unless the benefits outweigh the risks.
Danish: Der er ingen erfaring med anvendelsen af Kalydeco hos patienter med svært nedsat leverfunktion, derfor bør det ikke anvendes til disse patienter, medmindre fordelene opvejer risici.
English: • Cardiac glycosides such as digoxin, used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation
Danish: • hjerteglycosider, såsom digoxin, der anvendes til behandling af let til moderat kronisk hjertesvigt og en unormal hjerterytme, der kaldes atrieflimren.
English: Table 8: Mean (SD) of ivacaftor exposure when used in combination with tezacaftor, by age group
Danish: Tabel 8: Gennemsnitlig (SD) ivacaftor-eksponering når anvendt i kombination med tezacaftor, i henhold til aldersgruppe Aldersgruppe
English: Interim analysis 1: December 2017 Interim analysis 2: December 2019 Interim analysis 3: December 2021 Final report: December 2023
Danish: Interimanalyse 3: December 2021
English: • Nausea or vomiting
Danish: • kvalme eller opkastning
English: If possible, have your child's medicine and this leaflet with you.
Danish: Hvis det er muligt, skal du medbringe dit barns medicin og denne indlægsseddel.
English: The recommended dose of Kalydeco in combination with tezacaftor/ivacaftor is one tezacaftor/ivacaftor tablet in the morning and one Kalydeco 150 mg tablet in the evening.
Danish: Den anbefalede dosis af Kalydeco i kombination med tezacaftor/ivacaftor er én tablet med tezacaftor/ivacaftor om morgenen, og én tablet med 150 mg Kalydeco om aftenen.
English: If the patient's genotype is unknown, an accurate and validated genotyping method should be performed before starting treatment to confirm the presence of an indicated mutation in the CFTR gene (see section 4.1).
Danish: Hvis patientens genotype er ukendt, skal genotypebestemmelse udføres ved en præcis og valideret metode før behandlingsstart, så tilstedeværelsen af en indiceret mutation i CFTR-genet bekræftes (se pkt.
English: Kalydeco dosing recommendations are provided in Table 1.
Danish: Doseringsanbefalinger for Kalydeco kan ses i tabel 1.
English: Ivacaftor has been studied with an oestrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the oral contraceptive.
Danish: Ivacaftor er blevet undersøgt sammen med oral kontraception indeholdende østrogen/progesteron, og der blev ikke fundet nogen signifikant indvirkning på eksponeringen for det orale kontraceptivum.
English: Each film-coated tablet contains 167.2 mg of lactose (as monohydrate)
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 167,2 mg lactose (som monohydrat)
English: Two patients, one on placebo and one on ivacaftor permanently discontinued treatment for elevated transaminases, each > 8 x ULN.
Danish: To patienter, en på placebo og en på ivacaftor seponerede permanent behandlingen som følge af forhøjede aminotransferaser, hver >8 x ULN.
English: • Increased liver enzymes in the blood have been seen in some people receiving Kalydeco (alone or in combination with tezacaftor/ivacaftor).
Danish: • Forhøjede niveauer af leverenzymer i blodet er blevet observeret hos nogle personer, der fik Kalydeco (alene eller i kombination med tezacaftor/ivacaftor).
English: Severe (Child-Pugh Class C)
Danish: Svær (Child-Pugh klasse C)
English: • Meats, oily fish
Danish: • kød, fed fisk
English: Absolute change from baseline in percent predicted FEV1 (percentage points) N
Danish: Absolut ændring fra baseline i procent af forventet FEV1 (procentpoints) N
English: For patients aged 6 months to less than 24 months, with both baseline and week 24 values available, mean (SD) weight-for-age, length-for-age, and weight-for-length z-scores are provided in Table 6.
Danish: For patienter i alderen 6 måneder til under 24 måneder, hvor både værdier ved baseline og uge 24 var tilgængelige, er de gennemsnitlige (SD) z-scorer for vægt-for-alder, længde-for-alder og vægt-forlængde vist i tabel 6.
English: • Loss of appetite
Danish: • appetitløshed
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in the elderly patients (65-72 years) are comparable to those in younger adults.
Danish: De farmakokinetiske parametre for ivacaftor i kombination med tezacaftor hos de ældre patienter (65-72 år) er sammenlignelige med parametrene for yngre voksne.
English: Diarrhoea very common
Danish: Diarré meget almindelig
English: If you stop giving your child Kalydeco
Danish: Hvis du holder op med at give dit barn Kalydeco
English: The mean (SD) overall (both ivacaftor dosing groups combined) absolute change from baseline in BMI at week 24 was 0.32 kg/m2 (0.54) and the mean (SD) overall change in BMI-for-age z-score was 0.37 (0.42).
Danish: Den gennemsnitlige (SD) samlede (begge doseringsgrupper med ivacaftor kombineret) absolutte ændring fra baseline i BMI ved uge 24 var 0,32 kg/m2 (0,54), og den gennemsnitlige (SD) samlede ændring i BMI-for-alder z-score var 0,37 (0,42).
English: Each sachet of granules should be mixed with 5 mL of age-appropriate soft food or liquid and completely and immediately consumed.
Danish: Hvert brev med granulat skal blandes med 5 ml ”alderssvarende” mosede fødevarer eller 5 ml væske og skal indtages fuldstændigt straks derefter.
English: The mean change from baseline through week 24 in FEV1 (L) was 0.37 L in the ivacaftor group and 0.01 L in the placebo group in study 1 and 0.30 L in the ivacaftor group and 0.07 L in the placebo group in study 2.
Danish: Den gennemsnitlige ændring fra baseline til og med uge 24 i FEV1 (l) var 0,37 l i ivacaftorgruppen og 0,01 l i placebo-gruppen i studie 1, og 0,30 l i ivacaftor-gruppen og 0,07 l i placebogruppen i studie 2.
English: • Cheese, whole milk, whole-milk dairy products, yogurt, chocolate
Danish: • ost, sødmælk, sødmælksprodukter, yoghurt, chokolade
English: All 5 patients had maximum ALT or AST levels > 8 x ULN, which returned to baseline levels following interruption of dosing with ivacaftor granules.
Danish: Alle 5 patienter havde maksimale ALAT- eller ASAT-niveauer >8 x ULN, som vendte tilbage til baseline-niveauer efter afbrydelse af dosering med ivacaftorgranulat.
English: Ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, has not been studied in patients with CF who have undergone organ transplantation.
Danish: Ivacaftor, enten som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor, er ikke blevet undersøgt hos patienter med CF, som har gennemgået organtransplantation.
English: Following multiple doses of ivacaftor and tezacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had a 50% increase in ivacaftor AUC, and an approximate 36% and 10% increase in AUC and Cmax for tezacaftor, respectively.
Danish: Efter flere doser af ivacaftor og tezacaftor i 10 dage havde personer med en moderat nedsat leverfunktion (Child-Pugh klasse B, score 7 til 9) en 50 % forhøjelse af AUC for ivacaftor og en hhv. ca. 36 % og 10 % forhøjelse af AUC og Cmax for tezacaftor.
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAlLLESKRIFT
English: • Ringing in the ears
Danish: • rødmen i ørerne
English: If the patient's genotype is unknown, an accurate and validated genotyping method should be performed before starting treatment to confirm the presence of an indicated mutation in at least one allele of the CFTR gene (see section 4.1).
Danish: Hvis patientens genotype er ukendt, skal genotypebestemmelse udføres ved en præcis og valideret metode før behandlingsstart, så tilstedeværelsen af en indiceret mutation i mindst én allel af CFTR-genet bekræftes, før behandlingen påbegyndes (se pkt.
English: The impact of severe hepatic impairment (Child Pugh Class C, score 10 to15) on the pharmacokinetics of ivacaftor have not been studied.
Danish: Påvirkningen af svært nedsat leverfunktion (Child Pugh klasse C, score 10 til 15) på farmakokinetikken for ivacaftor er ikke undersøgt.
English: Serious adverse reactions in patients who received ivacaftor included abdominal pain and transaminase elevations (see section 4.4).
Danish: Alvorlige bivirkninger hos patienter, der fik ivacaftor, omfattede abdominalsmerter og stigninger i aminotransferaser (se pkt.
English: Kalydeco tablets should be taken with fat-containing food.
Danish: Kalydeco tabletter skal tages sammen med fedtholdig mad.
English: Therefore, use of Kalydeco monotherapy in these patients is not recommended.
Danish: Derfor bør Kalydeco-monoterapi ikke anvendes til disse patienter.
English: Mean (SD)
Danish: Gennemsnit (SD)
English: Ivacaftor, administered as monotherapy or in combination with tezacaftor, should be administered with fat-containing food.
Danish: Ivacaftor skal, administreret som monoterapi eller i kombination med tezacaftor, administreres sammen med fedtholdig mad.
English: Very limited data are available for elderly patients treated with ivacaftor (administered as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Danish: Meget begrænsede data er tilgængelige vedrørende ældre patienter behandlet med ivacaftor (administreret som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor).
English: If this is not possible, give it within the following hour after mixing.
Danish: Hvis dette ikke er muligt, skal barnet have blandingen inden for en time.
English: The mean (SD) overall change in percent predicted FEV1 from baseline at week 24 (exploratory endpoint) was 1.8 (17.81).
Danish: Den gennemsnitlige (SD) samlede ændring i procent forventet FEV1 fra baseline ved uge 24 (eksploratorisk endepunkt) var 1,8 (17,81).
English: The primary endpoint of safety was evaluated through week 24 (see section 4.8).
Danish: Det primære sikkerhedsendepunkt blev evalueret til og med uge 24 (se pkt.
English: Moderate (Child-Pugh Class B)
Danish: Moderat (Child-Pugh klasse B)
English: Your doctor may need to adjust your dose.
Danish: Lægen kan finde det nødvendigt at justere din dosis.
English: The safety and efficacy of Kalydeco in a combination regimen with tezacaftor/ivacaftor in children aged less than 12 years have not been established.
Danish: Kalydecos sikkerhed og virkning i et kombinationsregime med tezacaftor/ivacaftor hos børn i alderen under 12 år er ikke klarlagt.
English: At week 8
Danish: Ved uge 8
English: • Changes in the type of bacteria in mucus
Danish: • ændrede bakterietyper i slim
English: Forty-eight (48) patients from study 2 were rolled over in study 4, 22 in the placebo/ivacaftor group and 26 in the ivacaftor/ivacaftor group.
Danish: 48 patienter fra studie 2 indgik i studie 4, 22 i placebo/ivacaftor-gruppen og 26 i ivacaftor/ivacaftor-gruppen.
English: Efficacy results from a Phase 2 study in patients with CF who are homozygous for the F508del mutation in the CFTR gene showed no statistically significant difference in FEV1 over 16 weeks of ivacaftor treatment compared to placebo (see section 5.1).
Danish: Resultater for virkning fra et fase 2-studie hos patienter med CF, som er homozygote for F508delmutationen i CFTR-genet, viste ingen statistisk signifikant forskel i FEV1 i løbet af 16-ugers behandling med ivacaftor, sammenlignet med placebo (se pkt.
English: Secondary and exploratory efficacy endpoints evaluated were absolute change from baseline in sweat chloride through 24 weeks of treatment, absolute change from baseline in weight, body mass index (BMI) and stature (supported by weight, BMI and stature z-scores) at 24 weeks of treatment, and measures of pancreatic function such as Faecal Elastase-1.
Danish: Sekundære og eksploratoriske evaluerede virkningsendepunkter var absolut ændring fra baseline i sved-chlorid til og med 24 ugers behandling, absolut ændring fra baseline i vægt, body mass index (BMI) og statur (støttet af z-scorer for vægt, BMI og statur) efter 24 ugers behandling og måling af pankreasfunktion såsom fækal elastase-1.
English: The safety and efficacy of Kalydeco monotherapy in children aged less than 6 months with a gating (class III) mutation have not been established.
Danish: Kalydecos sikkerhed og virkning som monoterapi hos børn under 6 måneder med en gating (klasse III)-mutation er ikke klarlagt.
English: Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)
Danish: Pakningsstørrelse på 56 breve (indeholder 4 enkeltmapper med 14 breve i hver).
English: Tell your child's doctor or pharmacist if your child is using, has recently used or might use any other medicines.
Danish: Fortæl altid dit barns læge eller apotekspersonalet, hvis dit barn bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in adolescent patients (12 to 17 year-olds) are comparable to those in adults (see Table 8).
Danish: De farmakokinetiske parametre for ivacaftor i kombination med tezacaftor hos unge patienter (12 til 17 år) er sammenlignelige med parametrene for voksne (se tabel 8).
English: Ivacaftor should be administered with fat-containing food.
Danish: Ivacaftor skal administreres sammen med fedtholdig mad.
English: One tablet of tezacaftor 100 mg/ivacaftor 150 mg should be taken twice a week, taken approximately 3 to 4 days apart.
Danish: Én tablet tezacaftor 100 mg/ivacaftor 150 mg skal tages to gange ugentligt med ca. 3 til 4 dages mellemrum.
English: Always give your child this medicine exactly as your child's doctor has told you to.
Danish: Giv altid dit barn lægemidlet nøjagtigt efter dit barns læges anvisning.
English: However, in patients with the G970R-CFTR mutation, the mean (SD) absolute change in sweat chloride at week 8 was -6.25 (6.55) mmol/L.
Danish: Hos patienter med G970R-CFTR-mutation var den gennemsnitlige (SD) absolutte ændring i sved-chlorid ved uge 8 imidlertid -6,25 (6,55) mmol/l.
English: There is no experience of the use of Kalydeco monotherapy or in combination with tezacaftor/ivacaftor in patients with severe hepatic impairment.
Danish: Der er ingen erfaring med anvendelsen af Kalydeco som monoterapi eller i kombination med tezacaftor/ivacaftor hos patienter med svært nedsat leverfunktion.
English: A fat-containing meal or snack should be consumed just before or just after dosing.
Danish: Et fedtholdigt måltid eller mellemmåltid skal indtages lige før eller lige efter medicinindtagelsen.
English: For patients in the ivacaftor/ivacaftor group from study 1, the annualised rate of pulmonary exacerbations was 0.57 events/year across day 1 to week 48 when patients were on ivacaftor.
Danish: For patienter i ivacaftor/ivacaftor-gruppen fra studie 1 var den annualiserede hyppighed af lungeeksacerbationer 0,57 hændelser/år over dag 1 til uge 48, når patienterne fik ivacaftor.
English: Table 2: Adverse reactions in ivacaftor-treated patients aged 6 months and older System organ class
Danish: Tabel 2: Bivirkninger hos ivacaftor-behandlede patienter i alderen 6 måneder og derover Systemorganklasse
English: Part B of study 8 enrolled, 19 patients aged 12 months to less than 24 months (mean age 15.2 months at baseline), with 18 patients completing the 24-week treatment period, and 11 patients aged 6 months to less than 12 months (mean age 9.0 months at baseline) with all 11 patients completing the 24-week treatment period.
Danish: Del B af studie 8 inkluderede 19 patienter i alderen 12 måneder til under 24 måneder (gennemsnitlig alder på 15,2 måneder ved baseline), hvoraf 18 patienter gennemførte den 24-ugers behandlingsperiode, og 11 patienter i alderen 6 måneder til under 12 måneder (gennemsnitlig alder 9,0 måneder ved baseline), hvor alle 11 patienter gennemførte den 24-ugers behandlingsperiode.
English: When co-administered with moderate inhibitors of CYP3A, the dose of Kalydeco and tezacaftor/ivacaftor should be adjusted according to the recommendations in Table 1 (see section 4.4 and 4.5).
Danish: Ved administration sammen med moderate hæmmere af CYP3A, skal dosen af Kalydeco og tezacaftor/ivacaftor justeres i henhold til anbefalingerne i tabel 1 (se pkt.
English: • Tear or cut sachet open along cut line.
Danish: • Riv eller klip langs klippelinjen for at åbne brevet.
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating ivacaftor treatment.
Danish: Oftalmologiske undersøgelser ved start af behandlingen og som opfølgning anbefales hos pædiatriske patienter, der påbegynder behandling med ivacaftor.
English: The mean (SD) overall change from baseline in Faecal Elastase-1 (n = 27) was 99.8 µg/g (138.4).
Danish: Den gennemsnitlige (SD) samlede ændring fra baseline i fækal elastase-1 (n=27) var 99,8 µg/g (138,4).
English: Give the missed dose if less than 6 hours have passed since the time your child missed the dose.
Danish: Giv den glemte dosis, hvis der er gået under 6 timer fra dit barn skulle have haft en dosis.
English: After oral administration of a single 150 mg dose to healthy volunteers in a fed state, the mean (± SD) for AUC and Cmax were 10600 (5260) ng*hr/mL and 768 (233) ng/mL, respectively.
Danish: Efter oral administration af en enkelt 150 mg dosis til raske frivillige, som havde indtaget mad, var gennemsnittet (±SD) for AUC og Cmax hhv. 10600 (5260) ng*t/ml og 768 (233) ng/ml.
English: Gender The pharmacokinetic parameters of ivacaftor are similar in males and females.
Danish: Køn De farmakokinetiske parametre for ivacaftor er sammenlignelige for mænd og kvinder.
English: Findings of cataracts were observed in juvenile rats dosed from postnatal day 7 through 35 at ivacaftor exposure levels of 0.22 times the MRHD based on systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy.
Danish: Der blev observeret fund af grå stær hos unge rotter doseret fra dag 7 efter fødslen til og med dag 35 ved eksponeringsniveauer af ivacaftor på 0,22 gange MRHD baseret på den systemiske eksponering for ivacaftor og dets metabolitter, når det administreres som ivacaftor-monoterapi.
English: • if your child is allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis dit barn er allergisk over for ivacaftor eller et af de øvrige indholdsstoffer i Kalydeco (angivet i punkt 6).
English: The pharmacokinetic parameters of ivacaftor, either as monotherapy or in combination with tezacaftor, are similar in males and females.
Danish: De farmakokinetiske parametre for ivacaftor, enten som monoterapi eller i kombination med tezacaftor, er sammenlignelige for mænd og kvinder.
English: Table 4: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1
Danish: Tabel 4: Ivacaftors virkning på virkningsvariable i den samlede population og for specifikke CFTR-mutationer Absolut ændring i procent af forventet FEV1
English: Therefore, monitoring of the international normalised ratio (INR) is recommended during co-administration of warfarin with Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Danish: Derfor anbefales det, at den internationale, normaliserede ratio (INR) overvåges ved administration af warfarin sammen med Kalydeco (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor).
English: • Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents treated with Kalydeco (alone or in combination with tezacaftor/ivacaftor).
Danish: • En unormal linse i øjet (grå stær), der ikke påvirker synet, er blevet bemærket hos nogle børn og unge behandlet med Kalydeco (alene eller i kombination med tezacaftor/ivacaftor).
English: Sixty-two percent (24/39) of them carried the F508del-CFTR mutation in the second allele.
Danish: 62 % (24/39) var bærere af F508del-CFTR-mutationen i den anden allel.
English: Mild (Child-Pugh Class A)
Danish: Let (Child-Pugh klasse A)
English: Tablet film coat
Danish: Tablet filmovertræk
English: For patients in the placebo/ivacaftor group from study 1, the annualised rate of pulmonary exacerbations was higher in the initial study when patients were on placebo (1.34 events/year) than during the subsequent study 4 when patients rolled over to ivacaftor (0.48 events/year across day 1 to week 48, and 0.67 events/year across weeks 48 to 96).
Danish: For patienter i placebo/ivacaftor-gruppen fra studie 1 var den annualiserede hyppighed af lungeeksacerbationer højere i det indledende studie, hvor patienterne fik placebo (1,34 hændelser/år) end i det efterfølgende studie 4, hvor patienterne blev overført til ivacaftor (0,48 hændelser/år over dag 1 til uge 48 og 0,67 hændelser/år over uge 48 til 96).
English: In patients aged 6 months to less than 24 months, with both baseline and week 24 values available, sixteen patients were pancreatic insufficient at baseline (defined as Faecal Elastase-1 < 200 µg/g) with mean (SD) Faecal Elastase-1 values at baseline and week 24 of 19.8 µg/g (23) and 248.2 µg/g (135.6), respectively (mean [SD] absolute change 228.4 µg/g [136.5]).
Danish: Hos patienter i alderen 6 måneder til under 24 måneder, hvor både baseline- og uge 24-værdier var tilgængelige, havde 16 patienter pankreasinsufficiens ved baseline (defineret som fækal elastase-1 <200 µg/g) med gennemsnitlige (SD) fækal elastase-1-værdier ved baseline og uge 24 på hhv. 19,8 µg/g (23) og 248,2 µg/g (135,6) (gennemsnitlig [SD] absolut ændring 228,4 µg/g [136,5]).
English: If you forget to take Kalydeco
Danish: Hvis du har glemt at tage Kalydeco
English: • if you are allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for ivacaftor eller et af de øvrige indholdsstoffer i Kalydeco (angivet i punkt 6).
English: In part 2 of study 5, the mean (SD) absolute change in percent predicted FEV1 following 16 weeks (patients randomised to the ivacaftor/placebo treatment sequence in part 1) of continuous ivacaftor treatment was 10.4% (13.2%).
Danish: I del 2 af studie 5 var den gennemsnitlige (SD) absolutte ændring i procent forventet FEV1 efter 16 uger kontinuerlig ivacaftor-behandling (patienter randomiseret til ivacaftor/placebobehandlingssekvensen i del 1) 10,4 % (13,2 %).