FrancophonIA/ELRC3.0 huggingface dataset:
English: As dolutegravir and rilpivirine are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Danish: Da dolutegravir og rilpivirin i høj grad er bundet til plasmaproteiner, er det usandsynligt, at stofferne vil kunne elimineres signifikant ved hæmodialyse eller peritonealdialyse (se pkt.
English: Co-administration of Juluca with systemic dexamethasone is contraindicated (except as a single dose) see section 4.3.
Danish: Samtidig administration af Juluca og systemisk dexamethason er kontraindiceret (undtagen som en enkelt dosis), se pkt.
English: How to take Juluca
Danish: Sådan skal du tage Juluca
English: The most frequently reported adverse reactions considered possibly or probably related to the combined administration of dolutegravir plus rilpivirine in 513 HIV-1 infected subjects in the Phase III clinical trials (see section 5.1), were diarrhoea (2%) and headache (2%).
Danish: De hyppigst rapporterede bivirkninger, der anses for muligvis eller sandsynligvis at være relateret til den kombinerede administration af dolutegravir plus rilpivirin hos 513 personer inficeret med hiv-1 i fase III kliniske forsøg (se pkt.
English: Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/ Rilpivirine
Danish: Antacida (f.eks. aluminiummagnesiumhydroxid og/eller calciumcarbonat)/ rilpivirin
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir or rilpivirine.
Danish: Farmakokinetiske populationsanalyser tydede på, at co-infektion med hepatitis C-virus ikke havde nogen klinisk relevant effekt på eksponeringen for dolutegravir eller rilpivirin.
English: Cmin ↔ Cmax ↔
Danish: Cmin NA Cmax ↔
English: Rilpivirine ↑ Not studied.
Danish: Rilpivirin ↑ Ikke undersøgt.
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (38 times the 50 mg human clinical exposure based on AUC).
Danish: Oral administration af dolutegravir til drægtige rotter i doser op til 1.000 mg/kg dagligt fra dag 6 til 17 i drægtighedsperioden udløste ikke maternel toksicitet, udviklingstoksicitet eller teratogenicitet (38 gange den humane kliniske eksponering ved 50 mg baseret på AUC).
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Danish: In vitro hæmmer rilpivirin transportøren MATE-2K med IC50 på < 2,7 nM.
English: No dose adjustment is needed for patients with mild or moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat nyrefunktion.
English: Juluca must be taken with a meal (see section
Danish: Juluca skal tages sammen med et måltid (se pkt.
English: No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment (ChildPugh score A or B).
Danish: Det anses ikke for nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion (Child-Pugh-klasse A eller B).
English: This may result in loss of therapeutic effect of Juluca (induction of CYP3A enzymes).
Danish: Dette kan medføre tab af Julucas terapeutiske effekt (induktion af CYP3Aenzymer).
English: → Talk to your doctor for further advice on taking these medicines with Juluca.
Danish:  Tal med lægen for yderligere råd om, hvordan du skal tage disse lægemidler sammen med Juluca.
English: Calcium supplements, iron supplements or multivitamins Calcium supplements, iron supplements or multivitamins can stop Juluca being absorbed into your body and make it less effective.
Danish: Calciumtilskud, jerntilskud eller multivitaminer kan modvirke optagelsen af Juluca i kroppen og gøre det mindre effektivt.
English: Each pack consists of one bottle containing 30 film-coated tablets and a desiccant.
Danish: Hver pakning indeholder en beholder med 30 filmovertrukne tabletter og et tørremiddel.
English: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes).
Danish: Dolutegravir  AUC  5 % Cmax  16 % Cτ 30 % (induktion af UGT1A1 og CYP3A-enzymer).
English: Juluca should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Danish: Juluca skal anvendes med forsigtighed ved administration sammen med lægemidler med en kendt risiko for torsades de pointes.
English: No efficacy and safety data are available for the combination of dolutegravir and rilpivirine in pregnancy.
Danish: Der foreligger ingen data om virkningen og sikkerheden for kombinationen af dolutegravir og rilpivirin under graviditet.
English: There are limited data from the use of dolutegravir or rilpivirine in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af dolutegravir eller rilpivirin til gravide kvinder.
English: AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14%
Danish: R(-) methadon: AUC: ↓ 16 % Cmin: ↓ 22 %
English: Oxcarbazepine Phenytoin Phenobarbital/ Rilpivirine
Danish: Oxcarbazepin Phenytoin Phenobarbital/ rilpivirin
English: A risk for increases in dabigatran plasma concentrations cannot be excluded
Danish: Dabigatranetexilat  En risiko for stigning i plasmakoncentrationen af dabigatran kan ikke udelukkes (hæmning af intestinal P-gp).
English: This leaflet was last revised in.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: Lower exposures of dolutegravir and rilpivirine were observed during pregnancy.
Danish: Lave eksponeringer for dolutegravir og rilpivirin blev observeret under graviditet.
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.56 times the 50 mg human clinical exposure based on AUC).
Danish: Oral administration af dolutegravir til drægtige kaniner i doser op til 1.000 mg/kg dagligt fra dag 6 til 18 i drægtighedsperioden udløste ikke udviklingstoksicitet eller teratogenicitet (0,56 gange den humane kliniske eksponering ved 50 mg baseret på AUC).
English: When Juluca is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day should be taken at the same time with Juluca, for the duration of the rifabutin co-administration (a separate formulation of rilpivirine is available for this dose adjustment, see section 4.2).
Danish: pr. dag samtidigt med Juluca i den periode, hvor rifabutin administreres samtidigt (der findes en separat formulering af rilpivirin til denne dosisjustering, se pkt.
English: Antacids and supplements Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/
Danish: Antacida og tilskud Antacida (f.eks. aluminiummagnesiumhydroxid og/eller calciumcarbonat)/ dolutegravir
English: A dose adjustment of metformin should be considered when starting and stopping co-administration of Juluca with metformin, to maintain glycaemic control (see section 4.5).
Danish: Justering af metformindosis bør overvejes ved opstart eller ophør af samtidig administration af Juluca og metfomin for at opretholde glykæmisk kontrol (se pkt.
English: If possible, show them the Juluca pack.
Danish: Tag Julucapakningen med, hvis det er muligt.
English: Each bottle contains 30 film-coated tablets and a desiccant to reduce moisture.
Danish: Hver beholder indeholder 30 filmovertrukne tabletter og et tørremiddel for at mindske fugtindholdet.
English: The pharmacokinetics was evaluated in 11 children 6 to 12 years of age and showed that 25 mg once daily in patients weighing at least 20 kg and 35 mg once daily in patients weighing at least 30 kg resulted in dolutegravir exposure comparable to adults.
Danish: Farmakokinetikken blev evalueret hos 11 børn i alderen 6 til 12 år og viste, at 25 mg én gang dagligt hos patienter, som vejede mindst 20 kg,
English: Antimalarials Artemether/ Lumefantrine/ Dolutegravir
Danish: Malariamidler Artemether/lumefantrin/ dolutegravir
English: In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
Danish: Et studie hos raske forsøgspersoner viste, at supraterapeutiske doser rilpivirin (75 mg en gang dagligt og 300 mg en gang dagligt) forlængede QTc-intervallet på EKG (se pkt.
English: → Talk to your doctor for further advice on taking rifabutin with Juluca.
Danish:  Tal med lægen for yderligere råd om, hvordan du skal tage rifabutin sammen med Juluca.
English: If you vomit less than 4 hours after taking Juluca, take another tablet with a meal.
Danish: Hvis du kaster op inden for 4 timer efter at have taget Juluca, skal du tage en anden tablet sammen med et måltid.
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion (ChildPugh-klasse A eller B).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
Danish: YDRE KARTON (KUN ENKELTPAKNINGER)
English: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and to prevent fits) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis)
Danish: - carbamazepin, oxcarbazepin, phenobarbital, phenytoin (lægemidler til behandling af epilepsi og til forebyggelse af anfald).
English: Rilpivirine ↔ (Not studied)
Danish: Rilpivirin ↓ (Ikke undersøgt)
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Danish: Dolutegravirs IC50 mod forskellige laboratoriestammer var ved brug af PBMC 0,5 nM og lå ved brug af MT-4-celler i intervallet 0,7-2 nM. Der blev set tilsvarende IC50-værdier for kliniske isolater uden nogen større forskel mellem undertyperne; i et panel på 24 hiv-1-isolater af clade A, B, C, D, E, F og G og gruppe O var den gennemsnitlige IC50-værdi 0,2 nM (interval 0,02-2,14).
English: Juluca contains lactose.
Danish: Juluca indeholder lactose.
English: Antacids, to treat indigestion and heartburn, can stop Juluca being absorbed into your body and make it less effective.
Danish: Antacida, der anvendes til behandling af fordøjelsesbesvær og halsbrand, kan modvirke optagelsen af Juluca i kroppen og gøre det mindre effektivt.
English: Artemether/ Lumefantrine/ Rilpivirine
Danish: Artemether/lumefantrin/ rilpivirin
English: If you can't take these supplements at the same time as Juluca, do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Danish: Hvis du ikke kan tage disse tilskud samtidig med Juluca, må du ikke tage calciumtilskud, jerntilskud eller multivitaminer i 6 timer, før du tager Juluca, eller i mindst 4 timer efter at du har taget Juluca (se også punkt 3, 'Sådan skal du tage Juluca')
English: Of the 12 subjects that completed the study, 10 subjects were suppressed at the end of the study; in the other 2 subjects an increase in viral load was observed postpartum, for 1 subject due to suspected suboptimal adherence.
Danish: Hos de andre 2 personer blev der postpartum observeret en forøgelse i viral belastning, for 1 person på grund af suboptimal adhærens.
English: If calcium or iron supplements, or multivitamins cannot be taken at the same time as Juluca, these supplements are recommended to be administered 6 hours before or 4 hours after taking Juluca (see section
Danish: Hvis calcium- eller jerntilskud eller multivitaminer ikke kan tages samtidig med Juluca, anbefales det, at disse tilskud administreres 6 timer før eller 4 timer efter, at patienten har taget Juluca (se pkt.
English: Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Danish: Meget almindelig Forhøjet total faste-cholesterol
English: If you can't take these supplements at the same time as Juluca, do not take a calcium supplements, iron supplements or multivitamins during the 6 hours before you take Juluca, or for at least 4 hours after you take it.
Danish: Hvis du ikke kan tage disse tilskud samtidig med Juluca, må du ikke tage calciumtilskud, jerntilskud eller multivitaminer i 6 timer, før du tager Juluca, eller i mindst 4 timer efter at du har taget Juluca.
English: Atovaquone/ Proguanil/ Dolutegravir
Danish: Atovaquon/ proguanil/ dolutegravir
English: Co-administration of Juluca with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of Juluca.
Danish: Samtidig administration af Juluca og lægemidler, der øger gastrisk pH, kan resultere i nedsat plasmakoncentration af rilpivirin, hvilket muligvis kan reducere Julucas terapeutiske effekt.
English: AUC ↓ 14% Cmin NA Cmax ↓ 14%
Danish: Omeprazol AUC ↓ 14 % Cmin NA Cmax ↓ 14 %
English: Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Danish: Fås også i multipakninger, der indeholder 90 filmovertrukne tabletter (3 pakninger med 30 filmovertrukne tabletter i hver).
English: AUC ↑ 16%* Cmin ↔* Cmax ↑ 43%*
Danish: Rilpivirin AUC ↑ 16 %* Cmin ↔* Cmax ↑ 43 %*
English: Co-administration of Juluca with medicinal products that induce CYP3A may result in decreased plasma concentrations of rilpivirine, which could reduce the therapeutic effect of Juluca (see Table 1).
Danish: Samtidig administration af Juluca og lægemidler, der inducerer CYP3A, kan resultere i nedsat plasmakoncentration af rilpivirin, hvilket muligvis kan reducere Julucas terapeutiske effekt (se tabel 1).
English: Rilpivirine ↔
Danish: Rilpivirin ↔
English: AUC ↑ 23% Cmin ↑ 24% Cmax ↑ 19%
Danish: Tenofovir AUC ↑ 23 % Cmin ↑ 24 % Cmax ↑ 19 %
English: If a patient vomits within 4 hours of taking Juluca, another Juluca tablet should be taken with a meal.
Danish: Hvis en patient kaster op inden for 4 timer efter at have taget Juluca, skal patienten tage en anden Julucatablet sammen med et måltid.
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes).
Danish: Dolutegravir  AUC  54 % Cmax  43 % Cτ 72 % (induktion af UGT1A1 og CYP3A-enzymer).
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Danish: Hver tablet indeholder dolutegravirnatrium svarende til 50 mg dolutegravir og rilpivirinhydrochlorid svarende til 25 mg rilpivirin.
English: Do not take these medicines during the 12 hours before you take Juluca, or for at least 4 hours after you take it.
Danish: Tag ikke disse lægemidler i 12 timer, før du tager Juluca, eller i mindst 4 timer efter at du har taget Juluca.
English: AUC ↓ 42% Cmin ↓ 48% Cmax ↓ 31%
Danish: Rilpivirin AUC ↓ 42 % Cmin ↓ 48 % Cmax ↓ 31 %
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Danish: Hver filmovertrukken tablet indeholder dolutegravirnatrium svarende til 50 mg dolutegravir og rilpivirinhydrochlorid svarende til 25 mg rilpivirin.
English: NAME OF THE MEDICINAL PRODUCT Juluca 50 mg/25 mg film-coated tablets
Danish: Juluca 50 mg/25 mg filmovertrukne tabletter.
English: Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it.
Danish: Tag ikke et antacid i 6 timer, før du tager Juluca, eller i mindst 4 timer efter at du har taget Juluca.
English: Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Danish: Samtidig administration af Juluca og disse metaboliske inducere er kontraindiceret (se pkt 4.3).
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: If you take more Juluca than you should
Danish: Hvis du har taget for meget Juluca
English: In limited data from small numbers of women in study IMPAACT P1026 who received dolutegravir 50 mg once daily during the 2nd trimester of pregnancy, mean intra-individual values for total dolutegravir Cmax, AUC24h and C24h values were, respectively, 26%, 37% and 51% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 25%, 29% and 34% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6).
Danish: I begrænsede data fra et mindre antal kvinder i studiet IMPAACT P1026, som fik 50 mg dolutegravir en gang dagligt under graviditetetens 2. trimester, var de gennemsnitlige intraindividuelle værdier for Cmax, AUC24h og Cmin for total-dolutegravir henholdsvis 26 %, 37 % og 51 % lavere ved sammenligning med postpartum.
English: The combination of Juluca and dabigatran etexilate should be used with caution.
Danish: Kombinationen af Juluca og dabigatranetexilat skal anvendes med særlig forsigtighed.
English: Co-administration of Juluca with medicinal products that inhibit CYP3A may result in increased plasma concentrations of rilpivirine (see Table 1).
Danish: Samtidig administration af Juluca og andre lægemidler, der hæmmer CYP3A, kan resultere i øget plasmakoncentration af rilpivirin (se tabel 1).
English: Each pack of 30 film-coated tablets contains a desiccant.
Danish: Hver pakning med 30 tabletter indeholder et tørremiddel.
English: Co-administration may significantly decrease rilpivirine plasma concentration.
Danish: Samtidig administration kan nedsætte plasmakoncentrationen af rilpivirin signifikant.
English: Ketoconazole
Danish: Fluconazol
English: HMG CO-A reductase inhibitors Atorvastatin/
Danish: HMG CO-A reductasehæmmere Atorvastatin/ dolutegravir
English: Nervous system disorders very common headache dizziness common somnolence
Danish: Søvnighed Mave-tarm-kanalen Meget almindelig Kvalme
English: Baseline Third Treatment Agent Class INI
Danish: Lægemiddel i klassen af tredjebehandlingsmidler ved baseline
English: 40 mg single dose taken 4 hours after rilpivirine
Danish: Famotidin/ rilpivirin 40 mg som enkeltdosis taget 4 timer efter rilpivirin
English: Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.
Danish: Der er ingen tilgængelige kliniske data om patienter med samtidig infektion med hepatitis B. Læger henvises til de aktuelle retningslinjer for behandling af hiv-infektion hos patienter, der er co-inficeret med hepatitis B-virus.
English: If you have been told by your doctor that you have intolerance to some sugars, speak with your doctor before taking this medicine.
Danish: Tal med lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Calcium supplements, iron supplements or multivitamins must be taken at the same time as Juluca.
Danish: Calciumtilskud, jerntilskud eller multivitaminer skal tages samtidig med Juluca.
English: Significant decreases in rilpivirine plasma concentrations are expected.
Danish: Der forventes signifikant fald i plasmakoncentrationen af rilpivirin.
English: 40 mg single dose taken 12 hours before rilpivirine
Danish: Famotidin/ rilpivirin 40 mg som enkeltdosis taget 12 timer før rilpivirin
English: Dexamethasone/ Dolutegravir
Danish: Dexamethason/ dolutegravir
English: Rilpivirine ↔* EE ↔
Danish: Rilpivirin * EE 
English: • calcium supplements, iron supplements and multivitamins must be taken at the same time as Juluca with a meal.
Danish: • calciumtilskud, jerntilskud og multivitaminer skal tages samtidig med Juluca sammen med et måltid.
English: Co-administration may cause significant decreases in rilpivirine plasma concentrations.
Danish: Samtidig administration kan forårsage signifikant fald i plasmakoncentrationen af rilpivirin.
English: The combination of Juluca and antacids should be used with particular caution.
Danish: Kombinationen af Juluca og antacida skal anvendes med særlig forsigtighed.
English: Vardenafil Tadalafil/ Rilpivirine
Danish: Vardenafil Tadalafil/ rilpivirin
English: Antiviral active substances Tenofovir disoproxil / Dolutegravir1
Danish: Antivirale aktive stoffer Tenofovirdisoproxil/ dolutegravir1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/002
Danish: EU/1/18/1282/001 EU/1/18/1282/002
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions).
Danish: Dolutegravir  AUC  54 % Cmax  57 % C24  56 % (Kompleksbinding til polyvalente ioner).
English: 40 mg single dose taken 2 hours before rilpivirine
Danish: Famotidin/ rilpivirin 40 mg som enkeltdosis taget 2 timer før rilpivirin
English: The combination of Juluca and supplements should be used with particular caution.
Danish: Kombinationen af Juluca og tilskud skal anvendes med særlig forsigtighed.
English: Daclatasvir/ Rilpivirine
Danish: Daclatasvir/ rilpivirin
English: Sofosbuvir/ Velpatasvir/ Rilpivirine
Danish: Sofosbuvir/ velpatasvir/ rilpivirin
English: Don't stop unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Juluca, medmindre lægen beder dig om det.
English: • stomach (abdominal) pain or discomfort
Danish: • mavesmerter eller ubehag i maven
English: Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45%
Danish: Dolutegravir  AUC  33 % Cmax  29 % C  45 %
English: AUC ↑ 13% Cmin NA Cmax ↑ 21%
Danish: Rilpivirin AUC ↑ 13 % Cmin NA Cmax ↑ 21 %
English: Ledipasvir/Sofosbuvir / Rilpivirine
Danish: Ledipasvir/sofosbuvir / rilpivirin
English: Dolutegravir ↓ AUC ↓ 74% Cmax ↓ 72% C24 ↓ 74% (Complex binding to polyvalent ions).
Danish: Dolutegravir  AUC  74 % Cmax  72 % C24  74 % (Kompleksbinding til polyvalente ioner).
English: when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Danish: - dexamethason (et kortikosteroid, som bruges til behandling af mange tilstande, f.eks. betændelse og allergiske reaktioner), når det tages gennem munden eller som indsprøjtning, bortset fra som enkeltdosis - produkter, som indeholder perikon (Hypericum perforatum) (et naturlægemiddel, som anvendes mod depression).
English: Co-administration of Juluca with rifampicin is contraindicated (see section 4.3).
Danish: Samtidig administration af Juluca og rifampicin er kontraindiceret (se pkt 4.3).
English: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions).
Danish: Dolutegravir  AUC  39 % Cmax  37 % C24  39 % (Kompleksbinding til polyvalente ioner).
English: Rifapentine/ Dolutegravir
Danish: Rifapentin/ dolutegravir
English: Steadystate administration of rilpivirine 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, higher than the mean steady-state Cmax observed with the recommended 25 mg once daily dose of rilpivirine (see section 4.4).
Danish: Ved undersøgelse af supraterapeutiske doser rilpirivin på 75 mg en gang daglig og 300 mg en gang dagligt til raske voksne var de højeste gennemsnitlige tidsmæssigt afstemte (øvre konfidensgrænse på 95 %) forskelle i QTcF- interval i forhold til placebo efter baselinekorrektion henholdsvis 10,7 (15,3) og 23,3 (28,4) ms. Steady state-administration af rilpivirin 75 mg en gang dagligt og 300 mg en gang dagligt resulterede i et gennemsnitligt Cmax på henholdsvis ca. 2,6 og 6,7 gange højere end det gennemsnitlige Cmax ved steady state, der blev observeret med den anbefalede dosis rilpivirin på 25 mg en gang dagligt (se pkt.
English: Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (33 times the 50 mg human clinical exposure based on AUC).
Danish: 1.000 mg/kg/dag var den højeste dosis, der blev afprøvet (33 gange den humane kliniske eksponering ved 50 mg baseret på AUC).
English: Corticosteroids Prednisone/ Dolutegravir1
Danish: Kortikosteroider Prednison/ dolutegravir
English: Hepatic impairment
Danish: Meget almindelig Hovedpine