FrancophonIA/ELRC3.0 huggingface dataset:
English: Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with dasabuvir.
Swedish: Se produktresumén för de läkemedel som används i kombination med Exviera.
English: TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Swedish: TURQUOISE II - behandlingsnaiva eller pegIFN- + RBV-erfarna patienter med kompenserad cirros
English: PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
Swedish: PEARL III - genotyp 1b, behandlingsnaiva, utan cirros Design:
English: Prior pegIFN/RBV relapser
Swedish: Tidigare recidiv med pegIFN/RBV
English: Other
Swedish: Övriga
English: St. John's Wort (hypericum perforatum)
Swedish: VÄXTBASERADE LÄKEMEDEL Johannesört (hypericum perforatum)
English: In Part 2, subjects with HCV GT1 received dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 weeks.
Swedish: I del 2, fick patienter med HCV GT1 dasabuvir och ombitasvir/paritaprevir/ritonavir med eller utan ribavirin i 12 eller 24 veckor.
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Swedish: Dasabuvir och ombitasvir/paritaprevir/ritonavir med RBV i 12 veckor n/N % 95 % KI
English: 13/15 (86.7)c a. Calculated using the normal approximation to the binomial distribution b. 1 patient discontinued due to non-compliance c. Relapse in 2/15 patients (confirmed HCV RNA ≥ 15 IU/mL post-treatment before or during SVR12 window among subjects with HCV RNA < 15 IU/mL at last observation with at least 51 days of treatment).
Swedish: b. 1 patient avbröt på grund av bristande följsamhet c. Recidiv hos 2/15 patienter (bekräftat HCV RNA ≥ 15 IE/ml efter behandling före eller under SVR12
English: Enzyme inducers:
Swedish: Enzyminducerare:
English: They are always taken with other antiviral medicines such as ombitasvir/paritaprevir/ritonavir.
Swedish: De tas alltid tillsammans med andra virushämmande läkemedel som ombitasvir/paritaprevir/ritonavir.
English: 5 mg once daily
Swedish: 5 mg en gång dagligen
English: Mechanism: decrease possibly due to CYP1A2 induction by ritonavir dasabu vir +
Swedish: Mekanism: Minskning möjligen på grund av CYP1A2induktion av ritonavir.
English: Side effects when taking Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin:
Swedish: Biverkningar när Exviera används med ombitasvir/paritaprevir/ritonavir och ribavirin:
English: The majority of adverse reactions presented in Table 3 were of grade 1 severity in dasabuvir- and ombitasvir/paritaprevir/ritonavir-containing regimens.
Swedish: Merparten av biverkningarna som anges i Tabell 3 hade svårhetgrad 1 vid behandlingen med dasabuvir och ombitasvir/paritaprevir/ritonavir.
English: Film-coating
Swedish: Filmdragering:
English: dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 or 24 weeks with or without ribavirin (investigator chosen dose) for GT1 and GT4 infection
Swedish: Behandling: dasabuvir och ombitasvir/paritaprevir/ritonavir i 12 eller 24 veckor med eller utan ribavin (prövarbestämd dos) för GT1- och GT4-infektion.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Swedish: C. ÖVRIGA VILLKOR OCH KRAV FÖR GODKÄNNANDET FÖR FÖRSÄLJNING • Periodiska säkerhetsrapporter (PSUR)
English: Ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide atazanavir pharmacokinetic enhancement.
Swedish: Ritonavirdosen ingår i ombitasvir/ paritaprevir/ritonavir kommer att öka farmakokinetiken av atazanavir.
English: Mitotane
Swedish: Mitotan
English: What you need to know before you take Exviera 3.
Swedish: Vad Exviera är och vad det används för Vad du behöver veta innan du tar Exviera Hur du tar Exviera
English: ↑ rilpivirine
Swedish: ↑ rilpivirin
English: Mechanism: CYP3A4 induction by phenytoin.
Swedish: Mekanism: CYP3A4induktion av fenytoin
English: During clinical trials with dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin, transient elevations of ALT to greater than 5 times the upper limit of normal occurred in approximately 1% of subjects (35 of 3,039).
Swedish: Under kliniska studier med dasabuvir och ombitasvir/paritaprevir/ritonavir med eller utan ribavirin uppvisade 1 % (35 av 3039) av patienterna övergående serum ALAT-stegringar som var större än 5 gånger den övre normalvärdegränsen.
English: Enzalutamid e
Swedish: Enzalutamid
English: SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
Swedish: SVR12 för genotyp 1-infekterade behandlingsnaiva patienter i SAPPHIRE I
English: 0.75 mg single dose
Swedish: 0,75 mg enkeldos
English: Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection.
Swedish: Behandlade patienter (N=22) hade en medianålder på 54 år (intervall 34-68); 41 % var svarta; 14 % hade kompenserad cirros; 86 % var HCV-behandlingsnaiva; 14 % hade misslyckats med tidigare behandling med pegIFN/RBV; 68 % hade en HCV genotyp 1a-infektion.
English: Uncommon: may affect up to 1 in 100 people
Swedish: Mindre vanliga: kan förekomma hos upp till 1 av 100 personer
English: Lopinavir/ritonavir 400/100 mg twice daily or 800/200 mg once daily is contraindicated dasabuvir
Swedish: Lopinavir/ritonavir 400/100 mg två gånger eller 800/200 mg en gång dagligen är kontraindicerat med dasabuvir och ombitasvir/paritaprevir/ ritonavir pga.
English: SEDATIVES / HYPNOTICS Zolpidem
Swedish: SÖMNMEDEL OCH LUGNANDE MEDEL Zolpidem
English: Pooled efficacy analysis
Swedish: Samlad effektanalys
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Swedish: Arm A: dasabuvir och ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
English: Pravastatin 10 mg once daily
Swedish: Pravastatin 10 mg en gång dagligen.
English: Hepatic decompensation and hepatic failure
Swedish: Leverdekompensation och leversvikt
English: Genotype 1b, without cirrhosis or with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir
Swedish: Genotyp 1b, utan cirros eller med kompenserad cirros dasabuvir + ombitasvir/paritaprevir/ritonavir
English: Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Swedish: Mekanism: CYP3A4hämning av ritonavir och UGThämning av paritaprevir, ombitasvir och dasabuvir.
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Swedish: Mekanism: Troligtvis UGT1A1 hämning av paritaprevir, ombitasvir och dasabuvir.
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% were Black; 19% had compensated cirrhosis; 67% were treatment-naïve; 33% had failed prior treatment with pegIFN/RBV; 89% had HCV genotype 1a infection.
Swedish: Behandlade patienter (N = 63) hade en medianålder på 51 år (intervall 31-69); 24 % var svarta; 19 % hade kompenserad cirros; 67 % var behandlingsnaiva; 33 % hade misslyckats med tidigare behandling med pegIFN/RBV; 89 % hade en HCV genotyp 1a-infektion.
English: Dose normalized sirolimus ratios are shown for interaction with ombitasvir/paritaprevir/ritonavir + dasabuvir.
Swedish: Dosnormaliserad sirolimusratio visas för interaktionen med ombitasvir/paritaprevir/ritonavir + dasabuvir.
English: NA If clinically indicated, higher doses of omeprazole should be used.
Swedish: NA Högre doser av omeprazol bör användas om det är kliniskt indicerat.
English: Dasabuvir must always be administered together with ombitasvir/paritaprevir/ritonavir .
Swedish: Dasabuvir måste alltid administreras tillsammans ombitasvir/paritaprevir/ritonavir.
English: The majority of these ALT elevations were transient and assessed as related to dasabuvir and ombitasvir/paritaprevir/ritonavir.
Swedish: Merparten ALAT-stegringar var övergående och bedömdes vara relaterat till dasabuvir och ombitasvir/paritaprevir/ritonavir.
English: 400 mg once daily
Swedish: 400 mg en gång dagligen
English: Ciclosporin 100 mg dosed alone and 30 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Swedish: Ciklosporin 100 mg ensamt och 30 mg administrerat med dasabuvir + ombitasvir/paritaprevir/ritonavir.
English: They are always taken with another antiviral medicine containing ombitasvir/paritaprevir/ritonavir.
Swedish: De tas alltid tillsammans med andra virushämmande läkemedel innehållande ombitasvir/paritaprevir/ritonavir.
English: Atazanavir must be administered at dasabuvir ombitasvir
Swedish: Atazanavir måste administreras vid samma tidpunkt som dasabuvir + ombitasvir/paritaprevir/
English: 40 mg once daily
Swedish: 40 mg en gång dagligen
English: If you get any side effects, talk to your doctor or pharmacist.
Swedish: Om du får biverkningar, tala med läkare eller, apotekspersonal eller sjuksköterska.
English: Genotype 1a, without cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Swedish: Genotyp 1a, utan cirros dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
English: The M1 metabolite of dasabuvir had EC50 values of 39 and 8 nM against genotype 1a-H77 and 1bCon1 strains in HCV replicon cell culture assays, respectively, and the activity of the M1 metabolite was attenuated 3- to 4-fold in the presence of 40% human plasma.
Swedish: Dasabuvirs metabolit M1 hade EC50-värden på 39 respektive 8 nM mot genotyp 1a-H77 och 1b-CON1 stammar i HCV replikoncellsanalysen.
English: In Part 1b, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 weeks.
Swedish: I del 1b fick alla patienter dasabuvir och ombitasvir/paritaprevir/ritonavir tillsammans med ribavirin i 12 veckor.
English: SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
Swedish: SVR12 för genotyp 1a-infekterade behandlingsnaiva patienter i PEARL IV
English: ombitasvir/paritaprevir/ritonavir with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Swedish: Behandling: ombitasvir/paritaprevir/ritonavir med eller utan dasabuvir samadministrerat med eller utan viktbaserad ribavirin i 12 eller 24 veckor
English: Genotype 1a, with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Swedish: Genotyp 1a, med kompenserad cirros dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
English: SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
Swedish: SVR12 för genotyp 1b-infekterade behandlingsnaiva patienter i PEARL III
English: Sirolimus 2 mg was dosed alone, 0.5 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Swedish: Sirolimus 2 mg ensamt, 0,5 mg administrerat med dasabuvir + ombitasvir/paritaprevir/ritonavir.
English: In Part 1a, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 weeks.
Swedish: I del 1a, fick alla patienter dasabuvir och ombitasvir/paritaprevir/ritonavir tillsammans med ribavirin i 12 eller 24 veckor.
English: Tacrolimus or sirolimus whole blood concentrations should be monitored upon initiation and throughout co-administration with dasabuvir and ombitasvir/paritaprevir/ritonavir and the dose and/or dosing frequency should be adjusted as needed.
Swedish: Helblodskoncentrationen av takrolimus eller sirolimus ska kontrolleras vid inledning och under hela perioden av samtidig administrering med dasabuvir och ombitasvir/paritaprevir/ritonavir.
English: Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Swedish: Mekanism: Troligtvis UGThämning av paritaprevir, ombitasvir och dasabuvir.
English: 50 mg once daily
Swedish: 50 mg en gång dagligen
English: Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Swedish: Behandlade patienter (N = 419) hade en medianålder på 50 år (intervall: 19-70), 45,8 % var män; 4,8 % var svarta; 9,3 % hade en anamnes av depression eller bipolär sjukdom; 73,3 % hade baslinjenivåer av HCV-RNA på minst 800000 IE/ml; 20,3 % hade portal fibros (F2) och 10,0 % hade septal fibros (F3).
English: How to store Exviera
Swedish: Hur Exviera ska förvaras
English: For contra-indications with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Swedish: För kontraindikationer för ombitasvir/paritaprevir/ritonavir, se deras produktresumé.
English: 600 mg twice daily
Swedish: 600 mg två gånger dagligen
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Swedish: Takrolimus 2 mg ensamt och 2 mg administrerat med dasabuvir + ombitasvir/paritaprevir/ritonavir.
English: Mechanism: CYP2C19 induction by ritonavir.
Swedish: Mekanism: CYP2C19induktion av ritonavir
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV
Swedish: Arm A: dasabuvir och ombitasvir/paritaprevir/ritonavir + RBV
English: 250 mg single dose
Swedish: 500 mg enkeldos
English: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Swedish: TURQUOISE III: behandlingsnaiva eller pegIFN- + RBV-erfarna patienter med kompenserad cirros Design:
English: HCV Genotype 1a dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV
Swedish: HCV Genotyp 1a dasabuvir och ombitasvir/paritaprevir/ritonavir med RBV
English: GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (12 weeks)
Swedish: GT1b Dasabuvir och ombitasvir/paritaprevir/ritonavir (12 veckor)
English: This is due to liver function changes during treatment with dasabuvir + ombitasvir/paritaprevir/ ritonavir
Swedish: Detta på grund av förändringar i leverfunktionen under behandling med dasabuvir + ombitasvir/paritaprevir/ ritonavir.
English: 400 mg twice daily
Swedish: 400 mg två gånger dagligen
English: HCV Genotype 1b dasabuvir and ombitasvir/paritaprevir/ritonavir
Swedish: HCV Genotyp 1b dasabuvir och ombitasvir/paritaprevir/ritonavir
English: Refer to the Summary of Product Characteristics of ombitasvir/paritaprevir/ritonavir for its pharmacological properties.
Swedish: I produktresumén för ombitasvir/paritaprevir/ritonavir finns mer information om deras farmakologiska egenskaper.
English: Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV (24 weeks)
Swedish: Arm B: dasabuvir och ombitasvir/paritaprevir/ritonavir + RBV (24 veckor)
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Swedish: Arm A: dasabuvir och ombitasvir/paritaprevir/ritonavir + RBV Arm B: dasabuvir och ombitasvir/paritaprevir/ritonavir
English: Tell your doctor or pharmacist if you notice any of the following side effects: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir:
Swedish: Sluta att ta Exviera och kontakta omedelbart läkare eller sök vård om något av följande händer: Biverkningar när Exviera används med ombitasvir/paritaprevir/ritonavir med eller utan ribavirin:
English: Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Swedish: Behandlade patienter (N = 305) hade en medianålder på 54 år (intervall: 19-70); 65,2 % var män; 11,8 % var svarta;; 20,7 % hade en anamnes av depression eller bipolär sjukdom; 86,6 % hade baslinjenivåer av HCV RNA på minst 800000 IE/ml; 18,4 % hade portal fibros (F2) och 17,7 % hade septal fibros (F3).
English: Endpoint dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 Weeks N = 200a
Swedish: Dasabuvir och ombitasvir/paritaprevir/ritonavir med eller utan ribavirin i 12 eller 24 veckor N = 200a
English: Co-administration of dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine).
Swedish: Samtidig administrering av dasabuvir med läkemedel som primärt metaboliseras av UGT1A1 resulterar i förhöjda plasmakoncentrationer av dessa läkemedel.
English: Mechanism: CYP3A4 inhibition by ritonavir.
Swedish: Mekanism: CYP3A4hämning av ritonavir.
English: Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Swedish: Mekanism: UGT1A1hämning av paritaprevir, ombitasvir och dasabuvir.
English: • The other ingredients are:
Swedish: Frekvenserna definieras enligt följande:
English: Mechanism: P-gp inhibition by dasabuvir, paritaprevir, and ritonavir.
Swedish: Mekanism: P-gphämning av dasabuvir, paritaprevir och ritonavir
English: For interactions with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Swedish: För interaktioner med ombitasvir/ritonavir se deras produktresumé.
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Swedish: Behandlade patienter (N = 631) hade en medianålder på 52 år (intervall: 18 -70); 54,5 % var män; 5,4 % var svarta; 15,2 % hade en anamnes av depression eller bipolär sjukdom; 79,1 % hade baslinjenivåer av HCV RNA på minst 800000 IE/ml; 15,4 % hade portal fibros (F2) och 8,7 % hade septal fibros (F3); 67,7 % hade HCV-infektion genotyp 1a; 32,3 % hade HCV-infektion genotyp 1b.
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir
Swedish: Mekanism: CYP3A4/Pgp-hämning av ketokonazol och paritaprevir/ ritonavir/ ombitasvir
English: - Confusion - Notice swelling of your stomach area
Swedish: - märker av svullnad av magområdet.
English: NS5A M28T M28Ve
Swedish: NS5B A553T
English: Mechanism: CYP3A4 induction by carbamazepi ne.
Swedish: Mekanism: CYP3A4induktion av karbamazepin.
English: GIVE N WITH
Swedish: GIVEN MED
English: In subjects receiving dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea.
Swedish: De vanligaste rapporterade biverkningarna (mer än 20 % av patienterna) hos personer som fick dasabuvir och ombitasvir/paritaprevir/ritonavir med ribavirin var trötthet och illamående.
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Swedish: Övergående förhöjningar av serumbilirubin (främst okonjugerat) observerades hos patienter som fick dasabuvir och ombitasvir/paritaprevir/ritonavir med ribavirin, pga.
English: CYP3A4 inhibition by ritonavir.
Swedish: CYP3A4hämning av ritonavir
English: If clinically indicated, higher doses of esomeprazole/lansopraz ole may be needed.
Swedish: Högre doser av esomeprazol/lansoprazol bör användas om det är kliniskt indicerat.
English: Concomitant use is contraindicated (see
Swedish: Samtidig användning är kontraindicerat (se avsnitt
English: Exviera contains lactose.
Swedish: Exviera innehåller laktos.
English: Mechanism: OATP1B inhibition by paritaprevir.
Swedish: Mekanism: OATP1Bhämning av paritaprevir
English: Other pegIFN/RBV failures
Swedish: Tidigare utebliven respons med pegIFN/RBV
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Swedish: Arm A: dasabuvir och ombitasvir/paritaprevir/ritonavir + RBV (12 veckor)
English: • Vomiting
Swedish: • Uttorkning
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Swedish: Behandlade patienter (N = 380) hade en medianålder på 58 år (intervall: 21-71); 42,1 % var behandlingsnaiva, 36,1 % hade tidigare utebliven respons med pegIFN/RBV; 8,2 % hade tidigare partiell respons med pegIFN/RBV, 13,7 % hade tidigare recidiv pegIFN/RBV; 70,3 % var män; 3,2 % var svarta; 14,7 % hade trombocytantal under 90 x 109/l; 49,7 % hade ett albuminvärde under 40 g/l; 86,1 % hade baslinjenivåer av HCV RNA på minst 800000 IE/ml; 24,7 % hade en anamnes av depression eller bipolär sjukdom; 68,7 % hade HCV genotyp 1a, 31,3 % hade HCV genotyp 1b.
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Swedish: Mekanism: OATP1B hämning av paritaprevir och BCRPhämning av dasabuvir, paritaprevir och ritonavir.
English: Ethinyloestradiol containing oral contraceptives are contraindicated (see section 4.3).
Swedish: Etinylestradiol-innehållande orala preventivmedel är kontraindicerat (se avsnitt
English: Contents of the pack and other information What Exviera contains
Swedish: Hur Exviera ska förvaras Förpackningens innehåll och övriga upplysningar
English: Dose normalized cyclosporine ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Swedish: Dosnormaliserad ciklosporinratio visas för interaktion med dasabuvir + ombitasvir/paritaprevir/ritonavir.
English: IRON CHELATORS Deferasirox dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Swedish: JÄRNKELATKOMPLEXBILDARE Deferasirox Dasabuvir + ombitasvir/ paritaprevir/ ritonavir
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; ; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Swedish: Behandlade patienter (N = 179) hade en medianålder på 57 år (intervall: 26-70); 35,2 % hade tidigare utebliven respons med pegIFN/RBV; 28,5 % hade tidigare partiell respons med pegIFN/RBV, och 36,3 % hade tidigare recidiv med pegIFN/RBV; 54,2 % var män; 3,9 % var svarta; 12,8 % hade en anamnes av depression eller bipolär sjukdom; 87,7 % hade baslinjenivåer av HCV RNA på minst 800000 IE/ml; 17,9 % hade portal fibros (F2) och 14,0 % hade septal fibros (F3).
English: Two patients discontinued dasabuvir and ombitasvir/paritaprevir/ritonavir due to elevated ALT, including one on ethinyloestradiol.
Swedish: Två patienter avslutade behandlingen på grund av stegring i ALAT, inklusive en som använde etinylestradiol.
English: Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Swedish: Arm B: dasabuvir och ombitasvir/paritaprevir/ritonavir
English: AbbVie B.V. Tel: +31 (0)88 322 2843
Swedish: Tel: +31 (0)88 322 2843
English: dasabuvir and ombitasvir/paritaprevir/ritonavir with or without RBV for 12 or 24 weeks
Swedish: Behandling: dasabuvir och ombitasvir/paritaprevir/ritonavir med eller utan RBV i 12 eller 24 veckor
English: Dose normalized tacrolimus ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Swedish: Dosnormaliserad takrolimusratio visas för interaktion med dasabuvir + ombitasvir/paritaprevir/ritonavir.
English: ↔ ethinyl oestradiol
Swedish: Nevirapin Etravirin
English: CYP3A4 induction by St. John's
Swedish: CYP3A4induktion av johannesört.
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Swedish: Se avsnitt 4.4 och 5.1 för genotyp-specifik aktivitet mot hepatit C-virus (HCV).