FrancophonIA/ELRC3.0 huggingface dataset:
English: simeprevir + peginterferon alfa + ribavirin N = 781 n (%)
Danish: Puljede fase 3-studier simeprevir + peginterferon alfa + ribavirin N = 781 n (%)
English: It is not recommended to co-administer OLYSIO with rifampicin as co-administration may result in loss of therapeutic effect of OLYSIO.
Danish: Det anbefales ikke at administrere OLYSIO sammen med rifampicin, da det kan medføre manglende terapeutisk virkning af OLYSIO.
English: Genotype 4, treatment-naïve or treatment-experienced patients, with compensated cirrhosis or without cirrhosis treatment-naïve patients or prior relapsers: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV prior non-responder patients (partial and null responders): 12 weeks SMV + peg-IFN-alfa + RBV, followed by 36 weeks peg-IFN-alfa + RBV
Danish: 12 ugers SMV + peg-IFN-alfa + RBV efterfulgt af 12 eller 36 ugers peg-IFN-alfa + RBV patienter med tidligere manglende respons (delvist eller nul respons): 12 ugers SMV + peg-IFN-alfa + RBV efterfulgt af 36 ugers peg-IFN-alfa + RBV
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, photosensitivity reactions were reported in 4.7% of simeprevir-treated patients compared to 0.8% in placebo-treated patients (all grades; pooled phase 3).
Danish: Simeprevir i kombination med peginterferon alfa og ribavirin: I løbet af de 12 ugers behandling med simeprevir blev der indberettet fotosensibilitet hos 4,7% af de simeprevir-behandlede patienter sammenlignet med 0,8% i placebo-gruppen (alle grader; puljede fase 3-studier).
English: Eighty-eight percent (459/521) of the simeprevir-treated patients were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 88%.
Danish: 88% (459/521) af de simeprevir-behandlede patienter var egnede til en samlet behandlingsvarighed på 24 uger.
English: Resistance to simeprevir was characterised in HCV genotype 1a and 1b replicon-containing cells.
Danish: Celler, der indeholdt HCV-genotype 1a- og 1b-replikoner, var resistente over for simeprevir.
English: Table 22 shows the response rates in HCV genotype 1 infected patients with HIV-1 co-infection.
Danish: Tabel 22 viser responsraterne hos HCV-genotype 1-inficerede patienter med samtidig HIV 1
English: - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
Danish: - øget følsomhed for sollys (fotosensibilitet) - for meget bilirubin i blodet (bilirubin er et farvestof, der dannes i leveren) * Hududslæt kan ramme flere end 1 ud af 10 personer (meget almindelig bivirkning), hvis
English: Eighty-nine percent (54/61) of the simeprevir-treated treatment-naïve patients and prior relapsers without cirrhosis were eligible for 24 weeks of treatment; in these patients the SVR12 rate was 87%.
Danish: 89% (54/61) af de simeprevir-behandlede, behandlingsnaive patienter og patienter med tidligere recidiv uden cirrose var egnede til 24 ugers behandling.
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the first 12 weeks treatment with simeprevir, dyspnoea was reported in 11.8% of simeprevir-treated patients, compared to 7.6% in placebo-treated patients (all grades; pooled phase 3).
Danish: Simeprevir i kombination med peginterferon alfa og ribavirin: I løbet af de første 12 ugers behandling med simeprevir blev der indberettet dyspnø hos 11,8% af de simeprevir-behandlede patienter sammenlignet med 7,6% i placebo-gruppen (alle grader; puljede fase 3-studier).
English: Efficacy in treatment-experienced patients with HCV genotype 1 infection In study HPC3007 (PROMISE), patients who relapsed after prior IFN-based therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Danish: Effekt hos behandlingserfarne patienter med HCV-genotype 1-infektion I studie HPC3007 (PROMISE) fik patienter, der havde haft recidiv efter tidligere IFN-baseret behandling, simeprevir (150 mg én gang dagligt) + peginterferon alfa-2a + ribavirin i 12 uger efterfulgt af yderligere 12 eller 36 ugers behandling med peginterferon alfa-2a + ribavirin (se tabel 17 og 18).
English: Seventy-nine percent (404/509) of simeprevir-treated patients had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 90%.
Danish: 79% (404/509) af de simeprevir-behandlede patienter havde udetekterbart HCV-RNA ved uge 4.
English: Mild increases in concentrations of PDE-5 inhibitors may be expected.
Danish: Let forhøjede koncentrationer af disse antihistaminer kan forventes.
English: If adverse reactions, potentially related to the medicinal products that are used in combination with OLYSIO for the treatment of CHC, require dosage adjustment or interruption of the medicinal product(s), refer to the instructions outlined in the respective Summary of Product Characteristics for
Danish: Der henvises til produktresumeet for de respektive præparater, hvis der opstår bivirkninger, der kan være forbundet med de lægemidler, der anvendes i kombination med OLYSIO til behandling af CHC, og som kræver dosisjustering eller seponering af et eller flere af disse lægemidler.
English: HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a
Danish: HCV-geno-/undertype og forekomst af Q80K-polymorfisme i HCV-genotype 1a
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: Leverdekompensation og leverinsufficiens
English: Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT.
Danish: Raterne for virusrecidiv er beregnet med patienter med udetekterbart HCV-RNA ved den egentlige EOT som nævner.
English: Mild increased or decreased plasma
Danish: Der kan forekomme let forhøjet eller reduceret plasmakoncentration af sirolimus.
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, ‘blood bilirubin increased' was reported in 7.4% of simeprevir-treated patients, compared to 2.8% in placebo-treated patients (all grades; pooled phase 3).
Danish: Simeprevir i kombination med peginterferon alfa og ribavirin: I løbet af de 12 ugers behandling med simeprevir blev der indberettet forhøjet blodbilirubin hos 7,4% af de simeprevir-behandlede patienter sammenlignet med 2,8% i placebo-gruppen (alle grader; puljede fase 3-studier).
English: Then take the next dose of
Danish: Dosen skal tages sammen
English: Fluvastatin
Danish: Krydsresistens
English: 600 mg once daily efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.87 (0.81-0.93) ↔ simeprevir AUC 0.29 (0.26-0.33) ↓ simeprevir Cmax 0.49 (0.44-0.54) ↓ simeprevir Cmin 0.09 (0.08-0.12) ↓
Danish: 10 mg én gang dagligt escitalopram Cmax 1,03 (0,99-1,07) ↔ escitalopram Cmin 1,00 (0,95-1,05) ↔ simeprevir AUC 0,75 (0,68-0,83)  simeprevir Cmax 0,80 (0,71-0,89)  simeprevir Cmin 0,68 (0,59-0,79) 
English: Titrate the rosuvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Danish: Dosis af rosuvastatin skal titreres omhyggeligt, og den laveste nødvendige dosis skal anvendes.
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12.
Danish: Andelen af OLYSIO-behandlede patienter med HCV-RNA < 25 IE/ml detekterbart ved uge 4 var 14%
English: Table 8: ‘Blood bilirubin increased' events observed in Asian patients from the phase 3 study HPC3005 versus the pooled phase 3 studies C208, C216 and HPC3007 receiving simeprevir or placebo in combination with peginterferon alfa and ribavirin (first 12 weeks of treatment)
Danish: Tabel 8: Bivirkningen ‘forhøjet bilirubin i blodet', observeret hos asiatiske patienter fra fase 3-studiet HPC3005 vs. de puljede fase 3-studier C208, C216 og HPC3007.
English: - The days of the week are printed on the blister strip - this will help you remember to take your
Danish: - Ugedagene er trykt på blisterpakningen.
English: IMMUNOSUPPRESSANTS
Danish: Hjertearytmier
English: Cobicistat-containing medicinal products
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, patients should be tested for the presence of virus with the NS3 Q80K polymorphism before starting treatment (see section 4.4).
Danish: Hvis man overvejer OLYSIO-behandling i kombination med peginterferon alfa og ribavirin til HCVgenotype 1a-patienter, skal patienterne testes for virus med NS3 Q80K-polymorfisme før
English: 2-OH-atorvastatin AUC 2.29 (2.08-2.52) ↑ 2-OH-atorvastatin Cmax 1.98 (1.70-2.31) ↑
Danish: DXM AUC 1,08 (0,87-1,35) ↑ DXM Cmax 1,21 (0,93-1,57) ↑
English: Efficacy in patients with HCV genotype 4 infection In study HPC3011 (RESTORE), patients who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Danish: Effekt hos patienter med HCV-genotype 4-infektion I studie HPC3011 (RESTORE) fik patienter, der var behandlingsnaive, eller hvor tidligere pegIFN/RBV-behandling havde fejlet, simeprevir (150 mg én gang dagligt) + peginterferon alfa-2a + ribavirin i 12 uger efterfulgt af yderligere 12 eller 36 ugers behandling med peginterferon alfa-2a +
English: Carcinogenicity studies with
Danish: Karcinogenicitet og mutagenicitet
English: (CYP3A4 enzyme induction)
Danish: (Induktion af CYP3A4.)
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a
Danish: HCV-geno-/subtype og forekomst af Q80K-polymorfisme i HCV-genotype 1a ved baseline
English: Seventy-seven percent (200/259) of simeprevir-treated patients had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 87%.
Danish: 77% (200/259) af de simeprevir-behandlede patienter havde udetekterbart HCV-RNA ved uge 4.
English: Photosensitivity reactions have been observed with OLYSIO combination treatment (see section 4.8).
Danish: Der er observeret udslæt hos patienter, der fik kombinationsbehandling med OLYSIO (se pkt.
English: Felodipine
Danish: Amning
English: (intestinal CYP3A4 enzyme inhibition)
Danish: (Hæmning af intestinalt CYP3A4)
English: 0.035 mg once daily/ 1 mg once daily ethinylestradiol AUC 1.12 (1.05-1.20) ↔ ethinylestradiol Cmax 1.18 (1.09-1.27) ↑ ethinylestradiol Cmin 1.00 (0.89-1.13) ↔ norethindrone AUC 1.15 (1.08-1.22) ↔ norethindrone Cmax 1.06 (0.99-1.14) ↔ norethindrone Cmin 1.24 (1.13-1.35) ↑
Danish: ethinylestradiol AUC 1,12 (1,05-1,20) ↔ ethinylestradiol Cmax 1,18 (1,09-1,27)  ethinylestradiol Cmin 1,00 (0,89-1,13) ↔
English: EE-11415 Tallinn
Danish: 04100 Latina
English: Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or
Danish: Inkluderer patienter med recidiv og patienter med delvist eller nul respons inden behandling med interferon (pegyleret eller ikke-pegyleret) med eller uden ribavirin.
English: Chemistry Amylase
Danish: Resistens i cellekultur
English: Titrate the atorvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Danish: Dosis af atorvastatin skal titreres omhyggeligt, og den laveste nødvendige dosis skal anvendes.
English: If you have any further questions about any of these medicines, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis du vil vide mere om disse lægemidler.
English: Clarithromycin
Danish: Virusrecidiv
English: Discontinuation of simeprevir due to adverse reactions occurred in 0.9% of patients receiving simeprevir with peginterferon alfa and ribavirin.
Danish: 0,9% af de patienter, der fik simeprevir sammen med peginterferon alfa og ribavirin, seponerede simeprevir som følge af bivirkninger.
English: Nisoldipine
Danish: Rifabutin Rifapentin
English: Efficacy in patients with HCV genotype 1 and HIV-1 co-infection In study C212, patients with HIV-1 co-infection who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Danish: I studie C212 fik patienter med samtidig HIV 1-infektion, der var behandlingsnaive, eller hvor tidligere peg-IFN/RBV-behandling havde fejlet, simeprevir (150 mg én gang dagligt) + peginterferon alfa-2a + ribavirin i 12 uger efterfulgt af yderligere 12 eller 36 ugers behandling med peginterferon alfa-2a + ribavirin (se tabel 17 og 18).
English: HCV/HIV-1 co-infected patients.
Danish: Patienter med samtidig HIV-1-infektion
English: Daclatasvir 60 mg once daily daclatasvir AUC 1.96 (1.84-2.10) ↑ daclatasvir Cmax 1.50 (1.39-1.62) ↑ daclatasvir Cmin 2.68 (2.42-2.98) ↑ simeprevir AUC 1.44 (1.32-1.56) ↑ simeprevir Cmax 1.39 (1.27-1.52) ↑ simeprevir Cmin 1.49 (1.33-1.67) ↑
Danish: 800/100 mg én gang dagligt darunavir AUC 1,18 (1,11-1,25)  darunavir Cmax 1,04 (0,99-1,10) ↔ darunavir Cmin 1,31 (1,13-1,52)  ritonavir AUC 1,32 (1,25-1,40)  ritonavir Cmax 1,23 (1,14-1,32)  ritonavir Cmin 1,44 (1,30-1,61)  simeprevir AUC 2,59 (2,15-3,11) * simeprevir Cmax 1,79 (1,55-2,06) *
English: Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Danish: Janssen-Cilag AB c/o Vistor hf.
English: Titrate the lovastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Danish: Dosis af lovastatin skal titreres omhyggeligt, og den laveste nødvendige dosis skal anvendes.
English: Rīga, LV-1004
Danish: Karla Engliše 3201/06
English: Titrate the simvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Danish: Dosis af simvastatin skal titreres omhyggeligt, og den laveste nødvendige dosis skal anvendes.
English: DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied
Danish: 40 mg omeprazol AUC 1,21 (1,00-1,46)  omeprazol Cmax 1,14 (0,93-1,39)  omeprazol Cmin ikke undersøgt
English: It is not recommended to co-administer OLYSIO with products containing St John's wort as co-administration may result in loss of therapeutic effect of OLYSIO.
Danish: Det anbefales ikke at administrere OLYSIO sammen med præparater, der indeholder perikon, da det kan medføre manglende terapeutisk virkning af OLYSIO.
English: In particular tell your doctor or pharmacist if you take any of the following medicines:
Danish: Kontakt din læge eller apotekspersonalet, hvis du er i tvivl om, hvad du skal gøre.
English: (mild intestinal CYP3A4 enzyme inhibition)
Danish: (Svag hæmning af det intestinale CYP3A4
English: Disopyramide
Danish: dyspnø*
English: Mild increases in simeprevir concentrations may occur due to mild inhibition of OATP1B1 by sildenafil.
Danish: Let forhøjet koncentration af simeprevir kan opstå på grund af sildenafils svage hæmning af
English: 4.2 Posology and method of administration
Danish: 4.2 for oplysninger om pædiatrisk
English: CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine
Danish: ANTITUSSIVA Dextromethorphan (DXM)
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking OLYSIO.
Danish: Tal med din læge eller apotekspersonalet, inden du tager OLYSIO, hvis noget af ovenstående gør sig gældende for dig, eller hvis du er i tvivl.
English: Riprazo with food and drink
Danish: Brug af Riprazo sammen med mad og drikke
English: Therefore dialysis is not adequate to
Danish: Dialyse er derfor ikke tilstrækkeligt
English: The RMP shall include the following:
Danish: RMP'en skal indeholde følgende:
English: Some side effects can be serious:
Danish: Nogle bivirkninger kan være alvorlige:
English: The AUC is 50% higher in elderly (>65 years) than in young subjects.
Danish: AUC er 50 % højere hos ældre (> 65 år) end hos yngre individer.
English: Elderly patients aged 65 years and over
Danish: Ældre patienter 65 år eller derover
English: Keep your appointments with the doctor even if you
Danish: Overhold dine aftaler med lægen, også selvom
English: This medicine may make you feel dizzy and this can affect your ability to concentrate.
Danish: Dette lægemiddel kan få dig til at føle dig svimmel, og det kan påvirke din koncentrationsevne.
English: Within a month following the Commission Decision of the renewal procedure
Danish: Inden for en måned efter kommissionens beslutning for genregistreringsproceduren
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og blisterkortet.
English: There are no clinical data on fertility.
Danish: Der er ingen kliniske data vedrørende fertilitet.
English: The tablets should be swallowed whole with some water.
Danish: Tabletterne skal synkes hele med lidt vand.
English: In addition, an updated RMP should be submitted within 1 month after the Commission Decision of the renewal procedure.
Danish: Desuden skal der fremsendes en opdateret RMP inden for 1 måned efter Kommissionsbeslutningen for genregistrerinsproceduren.
English: A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people).
Danish: Nogle få patienter har oplevet disse alvorlige bivirkninger (forekommer hos op til 1 ud af 1.000 patienter).
English: Your doctor may prescribe Riprazo together with other medicines used to
Danish: Din læge kan ordinere Riprazo sammen med anden medicin, der bruges til
English: The use of Riprazo in children and adolescents up to 18 years of age is not recommended.
Danish: Riprazo anbefales ikke til børn og unge op til 18 år.
English: This condition should be corrected prior to administration of Riprazo, or the treatment should start under close medical
Danish: Denne tilstand bør korrigeres før administration af Riprazo, eller behandlingen skal indledes under nøje
English: Riprazo has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Danish: Riprazo er evalueret med henblik på sikkerhed hos mere end 7.800 patienter, herunder over 2.300, som var i behandling i mere end 6 måneder, og mere end 1.200, som var i behandling i over 1 år.
English: Do not take this medicine if you are pregnant or breast-feeding (see section Do not take Riprazo).
Danish: Du må ikke tage dette lægemiddel hvis du er gravid eller ammer (se afsnittet ”Tag ikke Riprazo”).
English: You should not take this medicine together with grapefruit juice.
Danish: Du må ikke tage dette lægemiddel sammen med grapefrugtjuice.
English: Riprazo has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged
Danish: Riprazo er undersøgt i 1.864 patienter i alderen 65 år eller derover og i 426 patienter
English: Your doctor may need to change your dose and/or to take other precautions if you are taking one of
Danish: Det kan være nødvendigt for din læge at ændre din dosis og/eller tage andre forsigtighedsregler, hvis
English: - medicines that increase the amount of potassium in your blood.
Danish: - medicin, der kan øge mængden af kalium i dit blod.
English: Date of first authorisation: 22 August 2007 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 22. august 2007 Dato for seneste fornyelse: 24. august 2012
English: The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy
Danish: Den antihypertensive effekt er til stede i betydelig grad inden for to uger (85-90 %) efter initiering af
English: Therefore, because of the risk of therapeutic failure, grapefruit juice should not be taken together with Riprazo.
Danish: På grund af risiko for terapeutisk svigt bør grapefrugtjuice ikke tages sammen med Riprazo.
English: Lowering the blood pressure to a normal level reduces the risk
Danish: Når blodtrykket sænkes til normalt niveau, mindskes risikoen for at få
English: What you need to know before you take Riprazo
Danish: Det skal du vide, før du begynder at tage Riprazo
English: A possible mechanism is saturation of transporters at the absorption site or at the hepatobiliary clearance route.
Danish: En mulig mekanisme er mætning af transportere på absorptionsstedet eller ved den hepatobiliære
English: It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible under-utilisation in clinical situations of
Danish: Det anbefales derfor at monitorere virkningen ved initiering og justering af furosemidbehandling for at undgå potentiel underudnyttelse i kliniske situationer med volumen
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: • senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering).
English: If you forget to take a dose of Riprazo, take it as soon as you remember and then take the next dose at its usual time.
Danish: Hvis du glemmer at tage Riprazo, skal du tage det så snart, du kommer i tanker om det, og derefter tage den næste dosis til sædvanlig tid.
English: - Second and third trimesters of pregnancy (see section 4.6).
Danish: - 2. og 3. trimester af graviditet (se pkt.
English: Riprazo helps to lower high blood pressure in adult patients.
Danish: Riprazo hjælper med at sænke et forhøjet blodtryk hos voksne patienter.
English: Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender,
Danish: Aliskiren er en effektiv en gang daglig antihypertensiv behandling til voksne patienter uanset køn,
English: The PSUR cycle for the medicinal product should follow the yearly cycle until otherwise agreed by the CHMP.
Danish: PSUR'er Lægemidlets PSUR-cyklus skal følge en årlig cyklus, indtil andet aftales med CHMP.
English: If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor.
Danish: Hvis du bliver gravid, mens du tager dette lægemiddel, skal du med det samme stoppe med at tage det og kontakte din læge.
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Danish: Muligheden for interaktioner med lægemidler ved P-gp's bindingssted vil sandsynligvis afhænge af, i hvor stor udstrækning denne transportør
English: The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne (tabel 1) er ordnet i frekvensgrupper med den mest almindelige først og ved anvendelse af følgende definition: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.
English: Riprazo was not teratogenic in rats or rabbits (see section 5.3).
Danish: Riprazo var ikke teratogent i rotter eller kaniner (se pkt.
English: The RMP shall include: - Deadlines for submission of the APOLLO study results.
Danish: RMP'en skal indeholde: - tidsfrister for indsendelse af rapport over studieresultater fra APOLLO.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Riprazo.
Danish: I kontrollerede kliniske forsøg blev klinisk relevante ændringer i standardlaboratorieparametre i få tilfælde associeret med administration af Riprazo.