FrancophonIA/ELRC3.0 huggingface dataset:
English: When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Danish: Når det gives med tenofovirdisoproxilfumarat, der bruges sammen med atazanavir/ritonavir, øgede Harvoni koncentrationen af tenofovir.
English: Harvoni is contraindicated with rifabutin (see section 4.3).
Danish: Harvoni er kontraindiceret sammen med rifabutin (se pkt.
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)d
Danish: Darunavir boostet med ritonavir (800 mg/ 100 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)d
English: Harvoni is contraindicated with rifampicin (see section 4.3).
Danish: Harvoni er kontraindiceret sammen med rifampicin (se pkt.
English: In study ION-4, 13 HCV/HIV-1 co-infected patients with genotype 1, including 1 cirrhotic patient, who had failed a sofosbuvir + ribavirin regimen were enrolled; the SVR was 100% (13/13) after 12 weeks of treatment with ledipasvir/sofosbuvir.
Danish: I studie ION-4 indgik 13 patienter med samtidig HCV/hiv 1-infektion med genotype 1, herunder 1 patient med cirrose, hvor et regime med sofosbuvir + ribavirin havde svigtet.
English: Adult and adolescent patients 12 years of age or older with genotype 3 CHC
Danish: Voksne og unge patienter 12 år eller ældre med genotype 3-CHC Patienter med kompenseret cirrose og/eller tidligere behandlingssvigt
English: If you take more Harvoni than you should
Danish: Hvis du har taget for meget Harvoni
English: LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC.
Danish: Ja a. En patient blev ekskluderet fra behandlingsarmen med 12 ugers LDV/SOF, og en patient blev ekskluderet fra behandlingsarmen med 24 ugers LDV/SOF+RBV, da begge patienter var inficeret med genotype 4 CHC.
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h
Danish: Ciclosporin (600 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)h
English: (Inhibition of CYP3A) Midazolam ↔ Cmax 0.95 (0.87, 1.04)
Danish: (Hæmning af CYP3A) Midazolam ↔ Cmax 0,95 (0,87; 1,04) ↔ AUC 0,89 (0,84; 0,95) (Induktion af CYP3A) Forventet:
English: For the same treatment arm, patients with baseline NS5A RAVs conferring a fold-change of > 100, relapse occurred in 4/13 (31%), as compared to 3/95 (3%) in those without any baseline RAVs or RAVs conferring a fold-change of ≤ 100.
Danish: For den samme behandlingsarm opstod der recidiv hos 4/13 (31 %) patienter med baseline-NS5A-RAVs, der gav >100 gange større ændring, sammenlignet med 3/95
English: Table 12: Response rates in study ION-1 LDV/SOF
Danish: Tabel 12: Responsrater i ION-1-studiet LDV/SOF
English: Table 14: Response rates in study ION-2 LDV/SOF
Danish: Tabel 14: Responsrater i studie ION-2 LDV/SOF
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Danish: HIV ANTIVIRALE STOFFER: HIV PROTEASEHÆMMERE Atazanavir boostet med ritonavir (300 mg/ 100 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
English: When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Danish: Når det gives med lopinavir/ritonavir, der bruges sammen med tenofovirdisoproxilfumarat, forventes Harvoni at øge koncentrationen af tenofovir.
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Danish: Protonpumpehæmmere Omeprazol (20 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis)c
English: When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir.
Danish: Når det gives med darunavir/ritonavir, der bruges sammen med tenofovirdisoproxilfumarat, øgede Harvoni koncentrationen af tenofovir.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c
Danish: Elvitegravir/ cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat (150 mg/ 150 mg/ 200 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c
English: b The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: b. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
English: 1.6-fold↑
Danish: Ledipasvir gange↑
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29)
Danish: Sofosbuvir ↓ Cmax 0,23 (0,19; 0,29) ↓ AUC 0,28 (0,24; 0,32)
English: ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Danish: Voksne med samtidig infektion med HCV/hiv - ERADICATE ERADICATE var et åbent studie til evaluering af 12 ugers behandling med ledipasvir/sofosbuvir hos 50 patienter med genotype 1 CHC med samtidig hiv-infektion.
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45)
Danish: Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30)
English: Harvoni + ribavirinA for 24 weeks (see sections 4.4 and 5.1).
Danish: Harvoni + ribavirinA i 24 uger (se pkt.
English: Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below.
Danish: 4.4) Ledipasvir/sofosbuvirs sikkerhed og virkning til behandling af non-genotype 1-infektion blev evalueret i små fase 2-studier.
English: ↑ Ritonavir
Danish: ↑ Ledipasvir
English: Site-directed mutagenesis of NS5A RAVs showed that substitutions conferring a fold-change > 100 and ≤ 1,000 in ledipasvir susceptibility are Q30H/R, L31I/M/V, P32L and Y93T in genotype 1a and P58D and Y93S in genotype 1b; and substitutions conferring a fold-change > 1,000 are M28A/G, Q30E/G/K, H58D, Y93C/H/N/S in genotype 1a and A92K and Y93H in genotype 1b.
Danish: Q30H/R, L31I/M/V, P32L og Y93T i genotype 1a og P58D og Y93S i genotype 1b, og substitutioner, der giver en >1.000 gange større ændring er M28A/G, Q30E/G/K, H58D, Y93C/H/N/S i genotype 1a og A92K og Y93H i genotype 1b.
English: Metavir score F0-F3 95% (94/99) CPT Ac
Danish: Efter transplantation Metavir-score F0-F3 CPT Ac
English: ↑ Cmin 1.53 (1.47, 1.59)
Danish: ↑ AUC 1,50 (1,42; 1,59)
English: Harvoni is contraindicated with carbamazepine (see section 4.3).
Danish: Harvoni er kontraindiceret sammen med carbamazepin (se pkt.
English: LDV/SOF 24 weeks (n = 109)
Danish: LDV/SOF 24 uger (n = 109)
English: LDV/SOF 12 weeks (n = 335)
Danish: LDV/SOF 12 uger (n = 335)
English: What Harvoni is and what it is used for What you need to know before you take Harvoni How to take Harvoni
Danish: Det skal du vide, før du begynder at tage Harvoni Sådan skal du tage Harvoni Bivirkninger
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Danish: HIV ANTIVIRALE STOFFER: REVERS TRANSKRIPTASEHÆMMERE Efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat (600 mg/ 200 mg/ 300 mg/ én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
English: LDV/SOF 8 weeks (n = 215)
Danish: LDV/SOF 8 uger (n = 215)
English: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Danish: • rifampicin og rifabutin (antibiotika, der anvendes til behandling af infektioner, herunder tuberkulose)
English: Abacavir ↔ Cmax 0.92 (0.87, 0.97)
Danish: Abacavir ↔ Cmax 0,92 (0,87; 0,97) ↔ AUC 0,90 (0,85; 0,94)
English: The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively.
Danish: Den højeste dokumenterede dosis af ledipasvir og sofosbuvir var hhv. 120 mg to gange dagligt i 10 dage, og en enkeltdosis på 1.200 mg. I disse studier med raske frivillige blev der ikke dokumenteret nogen uønskede virkninger ved disse dosisniveauer, og bivirkningerne var sammenlignelige med hensyn til hyppighed og sværhedsgrad med dem, der blev rapporteret i placebogrupperne.
English: ↑ Dabigatran ↔ Ledipasvir
Danish: ↑ Lopinavir ↑ Ritonavir
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Danish: Darunavir boostet med ritonavir (800 mg/ 100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c, d
English: ↔ Cmin 1.28 (1.21, 1.36)
Danish: ↔ AUC 1,31 (1,25; 1,36)
English: Dosed simultaneouslyf
Danish: Doseret samtidigtf
English: LDV/SOF+RBV 8 weeks (n = 210)
Danish: LDV/SOF+RBV 8 uger (n = 210)
English: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Danish: Emtricitabin/ rilpivirin/ tenofovirdisoproxilfumarat (200 mg/ 25 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
English: LDV/SOF 24 weeks (n = 217)
Danish: LDV/SOF 24 uger (n = 217)
English: LDV/SOF+RBV 8 weeks (n = 216)
Danish: LDV/SOF +RBV 8 uger (n = 216)
English: Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Danish: Atazanavir boostet med ritonavir (300 mg/ 100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c, d
English: Relapsea
Danish: Træthed
English: Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50)
Danish: Sofosbuvir ↑ Cmax 1,15 (0,88; 1,50) ↔ AUC 1,11 (1,00; 1,24)
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62)
Danish: Sofosbuvir ↓ Cmax 0,52 (0,43; 0,62) ↓ AUC 0,52 (0,46; 0,59) Cmin (NA)
English: It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
Danish: de to aktive stoffer i Harvoni, udskilles i modermælken.
English: LDV/SOF 12 weeks (n = 216)
Danish: LDV/SOF 12 uger (n = 216)
English: NS5A transient replicons Median (range)a
Danish: Stabile replikoner NS5A transitoriske replikoner
English: Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Danish: ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis)c,d
English: Pravastating
Danish: Famotidin
English: ↔ Cmin 1.07 (1.02, 1.13)
Danish: ↔ AUC 1,11 (1,02; 1,21)
English: NS5B transient replicons Median (range)a
Danish: Stabile replikoner NS5B transitoriske replikoner
English: ↔ Cmin 0.99 (0.80, 1.23)
Danish: ↔ AUC 1,04 (0,99; 1,08)
English: LDV/SOF 12 weeks (n = 211)
Danish: LDV/SOF 12 uger (n = 211)
English: Otherb
Danish: Recidiva
English: Ledipasvir ↑ Cmax 1.98 (1.78, 2.20)
Danish: ↑ AUC 1,96 (1,74; 2,21)
English: Table 9: Response rates in study ION-3 LDV/SOF
Danish: Tabel 9: Responsrater i ION-3-studiet LDV/SOV
English: ANTICOAGULANTS Dabigatran etexilate
Danish: ANTIKOAGULANTIA Dabigatranetexilat
English: ↔ Cmin 1.08 (1.01, 1.14)
Danish: ↔ AUC 1,04 (1,00; 1,08)
English: Treatment-naïve Patients without cirrhosis 100% (20/20) Patients with cirrhosis Treatment-experienced
Danish: Behandlingsnaive Patienter uden cirrose Patienter med cirrose Behandlingserfarne
English: LDV/SOF 12 weeks (n = 214)
Danish: LDV/SOF 12 uger (n = 214)
English: Ledipasvir ↓ Cmax 0.89 (0.61, 1.30)
Danish: Ledipasvir ↓ Cmax 0,89 (0,61; 1,30) ↓ AUC 0,96 (0,66; 1,39)
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43)
Danish: Sofosbuvir ↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57)
English: ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, 1.13)
Danish: S-methadon ↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
English: Cirrhosisd
Danish: Cirrosed
English: and <50 mL/min/1.73 m2)
Danish: Svært RI (eGFR <30 ml/min/ 1,73 m2)
English: Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
Danish: Ledipasvir ↓ Cmax 0,80 (0,69: 0,93) ↔ AUC 0,89 (0,76; 1,06)
English: ↔ Cmin 1.18 (1.13, 1.24)
Danish: ↔ AUC 1,27 (1,18; 1,37)
English: ACID REDUCING AGENTS
Danish: SYREREDUCERENDE STOFFER
English: Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
Danish: Ledipasvir ↓ Cmax 0,66 (0,59; 0,75) ↓ AUC 0,66 (0,59; 0,75) ↓ Cmin 0,66 (0,57; 0,76)
English: Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Danish: Samtidig administration af lægemidler, der er stærke P-glykoprotein (P-gp)-inducere i tarmen (carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon) vil nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir signifikant og kan medføre manglende virkning af Harvoni (se pkt.
English: Overall
Danish: I alt
English: Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42)
Danish: Sofosbuvir ↔ Cmax 1,12 (0,88; 1,42) ↔ AUC 1,00 (0,80; 1,25)
English: Cirrhosis
Danish: Cirrose
English: Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Danish: Sofosbuvir ↓ Cmax 0,64 (0,53; 0,77) ↓ AUC 0,76 (0,63; 0,91) Cmin (NA)
English: ↑ Cmin 1.91 (1.76, 2.08) Sofosbuvir ↑ Cmax 1.33 (1.14, 1.56)
Danish: Sofosbuvir ↑ Cmax 1,33 (1,14; 1,56) ↑ AUC 1,36 (1,21; 1,52)
English: Ledipasvir ↓ Cmax 0.83 (0.69, 1.00)
Danish: Ledipasvir ↓ Cmax 0,83 (0,69; 1,00) ↔ AUC 0,98 (0,80; 1,20)
English: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18)
Danish: Ciclosporin ↔ Cmax 1,06 (0,94; 1,18) ↔ AUC 0,98 (0,85; 1,14)
English: Cmin (NA)
Danish: Median (interval)a
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Danish: Tacrolimus ↓ Cmax 0,73 (0,59; 0,90) ↑ AUC 1,09 (0,84; 1,40)
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.19)
Danish: GS-331007 ↔ Cmax 1,09 (0,99; 1,19) ↔ AUC 1,02 (0,97; 1,08)
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69)
Danish: GS-331007 ↓ Cmax 0,60 (0,53; 0,69) ↔ AUC 1,04 (0,90; 1,20)
English: ↑ Cmin 1.39 (1.29, 1.51)
Danish: ↔ AUC 1,35 (1,29; 1,42)
English: ↔ Cmin 0.98 (0.79, 1.22)
Danish: ↔ AUC 0,97 (0,89; 1,05)
English: Norelgestromin ↔ Cmax 1.07 (0.94, 1.22)
Danish: Norelgestromin ↔ Cmax 1,07 (0,94; 1,22) ↔ AUC 1,06 (0,92; 1,21) ↔ Cmin 1,07 (0,89; 1,28)
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05)
Danish: GS-331007 ↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30)
English: ↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Danish: Cobicistat ↔ Cmax 1,25 (1,18; 1,32) ↑ AUC 1,59 (1,49; 1,70) ↑ Cmin 4,25 (3,47; 5,22)
English: • palpitations
Danish: Tabletkerne
English: ↔ Cmin 1.07 (0.89, 1.28) Norgestrel ↔ Cmax 1.18 (0.99, 1.41)
Danish: Norgestrel ↔ Cmax 1,03 (0,87; 1,23) ↔ AUC 0,99 (0,82; 1,20) ↔ Cmin 1,00 (0,81; 1,23)
English: • feeling tired
Danish: • træthed
English: ↑ Digoxin ↔ Ledipasvir
Danish: ↑ Digoxin ↔ Ledipasvir ↔ Sofosbuvir
English: ↔ Cmin 0.97 (0.86, 1.10) Ledipasvir ↑ Cmax 1.45 (1.34, 1.56)
Danish: Sofosbuvir ↑ Cmax 1,45 (1,10; 1,92) ↑ AUC 1,34 (1,12; 1,59)
English: Norelgestromin ↔ Cmax 1.02 (0.89, 1.16)
Danish: Norelgestromin ↔ Cmax 1,02 (0,89; 1,16) ↔ AUC 1,03 (0,90; 1,18) ↔ Cmin 1,09 (0,91; 1,31)
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Danish: Sofosbuvir ↔ Cmax 1,05 (0,93; 1,20) ↔ AUC 1,10 (1,01; 1,21)
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
Danish: GS-331007 ↔ Cmax 0,97 (0,83; 1,14) ↔ AUC 1,00 (0,87; 1,13)
English: These effects usually do not last longer than 30 minutes.
Danish: Disse virkninger varer normalt ikke længere end 30 minutter.
English: NO-0485 Oslo Norway
Danish: NO-0485 Oslo Norge
English: Regadenoson should not be used during pregnancy unless clearly necessary.
Danish: Regadenoson bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
English: More serious side effects include:
Danish: Mere alvorlige bivirkninger omfatter:
English: Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015
Danish: Dato for første markedsføringstilladelse: 06/09/2010 Dato for seneste fornyelse: 24/04/2015
English: They don't usually need any treatment.
Danish: De behøver normalt ikke at blive behandlet.
English: • if you are pregnant, think you are pregnant or planning to have a baby.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: Images are then taken of the heart.
Danish: Dernæst tages der billeder af hjertet.
English: The half-life of this initial phase is approximately 2 to 4 minutes.
Danish: Halveringstiden for denne indledende fase er ca. 2 til 4 minutter.
English: For the measurement of FFR, five independent studies have been conducted.
Danish: Til måling af FFR er der gennemført fem uafhængige undersøgelser.
English: Rapiscan with food and drink
Danish: Brug af Rapiscan sammen med mad og drikke
English: Classification agreement Cohen's kappa
Danish: Klassifikationsaftale Cohen's kappa
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: 400 micrograms
Danish: 400 mikrogram
English: The dose injected does not depend on your weight.
Danish: Den injicerede dosis afhænger ikke af din vægt.
English: Heart rate returns to baseline within 10 minutes.
Danish: Hjertefrekvensen vender tilbage til baseline i løbet af 10 minutter.
English: Your doctor will only give you Rapiscan if it is clearly necessary.
Danish: Din læge vil kun give dig Rapiscan, hvis det er klart nødvendigt.
English: Harmful effects have been seen in animal studies but it is not known if there is a risk to humans.
Danish: Der er blevet observeret skadelige virkninger i dyreforsøg, men det vides ikke, om der er en risiko for mennesker.
English: Safety and tolerability of repeated use of this product within 24 hours has not been characterised.
Danish: Sikkerhed og tolerabilitet ved gentagen brug af dette lægemiddel inden for 24 timer er ikke blevet karakteriseret.
English: Patients initiated exercise using a standard or modified Bruce protocol.
Danish: Patienterne startede træning ved brug af en standard eller modificeret Bruce-protokol.
English: This belongs to a group of medicines called ‘coronary vasodilators'.
Danish: Det tilhører en gruppe af medicin, som hedder ‘koronare vasodilatatorer'.
English: Tell your doctor straight away if you think you are having severe side effects.
Danish: Fortæl det straks til din læge, hvis du tror, at du har alvorlige bivirkninger.
English: Adverse reactions occurred in approximately 80% of patients.
Danish: Bivirkninger opstod hos ca. 80% af patienterne.
English: Children and adolescents Rapiscan should not be used in children and adolescents below the age of 18 years.
Danish: Børn og unge Rapiscan bør ikke anvendes til børn og unge under 18 år.
English: Ask your doctor for advice before using any medicine.
Danish: Spørg din læge til råds, før du bruger nogen form for medicin.
English: The side effects are usually mild.
Danish: Bivirkningerne er normalt milde.
English: The median time between scans was 7 days (range of 1-104 days).
Danish: Det mediane tidsinterval mellem skanningerne var 7 dage (interval på 1-104 dage).
English: Sensitivity Specificity
Danish: Sensitivitet Specificitet
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Danish: Indlægsseddel: Information til brugeren
English: It is not known whether Rapiscan can pass into breast milk and will only be given to you if your doctor thinks it is necessary.
Danish: Det er ukendt, om Rapiscan kan udskilles i brystmælk, og det vil kun blive givet til dig, hvis din læge mener, at det er nødvendigt.
English: • if you have low blood pressure (hypotension).
Danish: • hvis du har lavt blodtryk (hypotension).
English: The doctor, nurse or medical technician will let you know when you can stand up.
Danish: Lægen, sygeplejersken eller medicoteknikeren vil fortælle dig, hvornår du må rejse dig op.
English: Adenosine was treated as a gold standard to estimate sensitivity, specificity, and the proportion of accuracy.
Danish: Adenosin blev behandlet som guldstandard til at estimere sensitivitet, specificitet og nøjagtighed.
English: Effect of caffeine
Danish: Indvirkning af caffein
English: If any of these apply to you, tell your doctor before you are given the injection.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til din læge, før du får injektionen.
English: Suboptimal Exercise Stress Test
Danish: Suboptimal stresstest ved træning
English: All adverse reactions are presented in the table below and are listed by system organ class and frequency.
Danish: Alle bivirkninger er vist i tabellen nedenfor og er opstillet efter systemorganklasse og hyppighed.
English: Most increases resolved within 10 to 15 minutes, but in some cases, increases were observed at 45 minutes following administration.
Danish: De fleste stigninger forsvandt inden for 10-15 minutter, men i nogle tilfælde sås stigningerne 45 minutter efter indgiften.
English: They normally start soon after the Rapiscan injection and are usually over within 30 minutes.
Danish: De begynder normalt hurtigt efter injektionen med Rapiscan, og de er normalt overstået i løbet af 30 minutter.
English: However, the maximum observed plasma concentrations as well as volumes of distribution estimates were similar across the groups.
Danish: De maksimalt observerede plasmakoncentrationer samt estimater af fordelingsvoluminer var imidlertid sammenlignelige blandt grupperne.
English: The headache was considered severe in 3% of subjects.
Danish: Hovedpinen blev anset som alvorlig hos 3% af forsøgspersonerne.
English: The terminal phase consists of a decline in plasma concentration with a half-life of approximately 2 hours.
Danish: Den terminale fase består af en reduktion af plasmakoncentrationen med en halveringstid på ca. 2 timer.
English: However, given the proposed duration of use, the effects of the drug transporters are unlikely to be clinically relevant.
Danish: I betragtning af den påtænke anvendelsesvarighed er det dog usandsynligt, at lægemiddeltransportproteinernes virkninger vil være klinisk relevante.
English: Safety and tolerability testing
Danish: Test af sikkerhed og tolerabilitet
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Danish: Hyppighederne er defineret som meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10), ikke almindelige (≥ 1/1.000 til < 1/100) og sjælden (≥ 1/10.000 til < 1/1.000).
English: The risk of significant increases in blood pressure may be higher in patients with uncontrolled hypertension.
Danish: Risikoen for signifikante blodtryksstigninger kan være højere hos patienter med ukontrolleret hypertension.
English: Pack size of 1.
Danish: Pakningsstørrelse: 1.
English: Distribution Regadenoson is moderately bound to human plasma proteins (25-30%).
Danish: Fordeling Regadenoson bindes til humane plasmaproteiner i moderat grad (25-30 %).
English: • changes in heart tracing tests (electrocardiogram)
Danish: • ændringer i testresultater fra undersøgelser af hjertet (elektrokardiogram)
English: Dyspnoea did not correlate with a decrease in FEV1.
Danish: Der var ikke korrelation mellem dyspnø og reduktion i FEV1.
English: Do not use Rapiscan after the expiry date which is stated on the vial and carton after EXP.
Danish: Brug ikke Rapiscan efter den udløbsdato, der står på hætteglasset og æske efter EXP.
English: No serious cardiac adverse reactions occurred in patients receiving regadenoson 1 hour following inadequate exercise stress.
Danish: Der opstod ingen alvorlige hjertebivirkninger hos patienter, der fik regadenoson 1 time efter utilstrækkelig træningsinduceret stress.
English: • if you have heart failure.
Danish: • hvis du har hjertesvigt.