FrancophonIA/ELRC3.0 huggingface dataset:
English: (See section 4.4 Withdrawal of ritonavir only under restrictive conditions).
Danish: 4.4 Seponering af ritonavir udelukkende under restriktive omstændigheder).
English: d Ritonavir oral solution or capsule/tablet.
Danish: d Ritonavir oral opløsning eller kapsler/tabletter.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter opblanding af lægemidlet, se pkt.
English: If you miss a dose or if you forget to give your child a dose, take or give the missed dose as soon as possible with food and then take or give the next scheduled dose at its regular time.
Danish: Hvis du glemmer en dosis eller glemmer at give dit barn en dosis, skal du tage eller give den manglende dosis så hurtigt som muligt sammen med et måltid, og derefter tage næste planlagte dosis til sædvanlig tid.
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Danish: Under hiv-behandling kan der forekomme vægtstigning samt forhøjede niveauer af lipider og glucose i blodet.
English: The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.
Danish: Stoffet blokerer bearbejdningen af virale gagpol-proteiner i hiv-1 inficerede celler og hindrer dermed dannelsen af modne virioner og infektion af andre celler.
English: *Ritonavir capsules, tablets or oral solution may be used.
Danish: *Ritonavirkapsler, -tabletter eller oral opløsning kan anvendes.
English: If the patient has developed SJS or DRESS associated with the use of REYATAZ, REYATAZ may not be restarted.
Danish: Hvis patienten har udviklet SJS eller DRESS under behandling med REYATAZ, bør REYATAZ-behandling ikke genoptages.
English: The proportion of patients with HIV RNA < 400 copies/ml were 53% and 43% for ATV/RTV and 54% and 46% for LPV/RTV at weeks 48 and 96 respectively.
Danish: Andelen af patienter med hiv-RNA < 400 kopier/ml var 53% og 43% for ATV/RTV og 54% og 46% for LPV/RTV ved henholdsvis uge 48 og 96.
English: The use of REYATAZ in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.
Danish: Anvendelse af REYATAZ til børn under 3 måneder og som vejer under 5 kg, er ikke blevet undersøgt på grund af risikoen for alvorlige komplikationer.
English: common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance a These adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to REYATAZ in randomised controlled and other available clinical trials (n = 2321).
Danish: almindelig: træthed ikke almindelig: brystsmerter, ubehag, pyreksi, asteni sjælden: gangforstyrrelser a Disse bivirkninger blev identificeret under post-marketing-overvågning, men hyppigheden er dog estimeret ud fra en statistisk beregning baseret på det totale antal patienter, der har været eksponeret for REYATAZ i randomiserede, kontrollerede og andre tilgængelige kliniske studier (n = 2.321).
English: What you need to know before you take REYATAZ 3.
Danish: Det skal du vide, før du begynder at tage REYATAZ 3.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REYATAZ 50 mg ORAL POWDER - FOIL SACHET 1.
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER REYATAZ 50 mg ORALT PULVER - FOLIEBREV 1.
English: In a multiple-dose study in HIVinfected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
Danish: I et flerdosis-studie med hivinficerede patienter, der fik 400 mg atazanavir én gang dagligt med et let måltid i 12 uger, kunne atazanavir påvises i cerebrospinalvæsken og sæd.
English: After mixing with food or beverage, mixture may be stored for up to 1 hour at temperatures not above 30°C.
Danish: Efter opblanding med føde eller drikke, kan blandingen opbevares i op til 1 time ved temperaturer under 30°C.
English: Assessment of the pharmacokinetics, safety, tolerability, and virologic response of REYATAZ oral powder was based on data from two open-label, multicenter clinical trials.
Danish: Vurderingen af farmakokinetik, sikkerhed, tolerabilitet og virologisk respons for REYATAZ oralt pulver var baseret på data fra to åbne, multicenterundersøgelser.
English: Co-administration of REYATAZ with voxilaprevircontaining products is expected to increase the concentration of voxilaprevir.
Danish: Samtidig administration af REYATAZ med produkter indeholdende voxilaprevir forventes at øge koncentrationen af voxilaprevir.
English: Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much REYATAZ.
Danish: Hvis du har taget for mange REYATAZ-kapsler Gulfarvning af huden/øjnene (gulsot) og uregelmæssig hjerterytme (QTc-forlængelse) kan forekomme, hvis du eller dit barn har taget for meget REYATAZ.
English: Cut each sachet along the dotted line.
Danish: Klip langs den stiplede linje.
English: Table 6: Efficacy Outcomes at Week 48a and at Week 96 (Study 045) Parameter
Danish: Tabel 6: Effektresultater ved uge 48a og uge 96 (Studie 045) Parameter
English: Table 5: Efficacy Outcomes in Study 138 a Parameter
Danish: Tabel 5: Effektresultater i Studie 138a Parameter
English: REYATAZ + saquinavir was shown to be inferior to lopinavir + ritonavir.
Danish: REYATAZ + saquinavir er vist at være ringere end lopinavir + ritonavir.
English: ANTIEPILEPTICS
Danish: ANTIEPILEPTIKA
English: It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Danish: Mødre med hiv-infektion frarådes at amme, da virus kan overføres gennem mælken.
English: Interactions between atazanavir and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Interaktioner mellem atazanavir og andre lægemidler angives i tabellen nedenfor (stigninger er angivet med “↑”, fald med “↓”, ingen ændring med “↔”).
English: Of importance, many studies were conducted with unboosted atazanavir, which is not the approved regimen of atazanavir.
Danish: Det er vigtigt at nævne, at mange studier er udført med ikke-boostet atazanavir, hvilket ikke er det godkendte atazanavir-regime.
English: Do not take or give a double dose to make up for a forgotten dose.
Danish: Du må ikke tage eller give en dobbeltdosis som erstatning for den glemte dosis.
English: The increase in progestin exposure may lead to related side-effects (e.g. insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance.
Danish: Den øgede progestin-eksponering kan give bivirkninger (f.eks. insulinresistens, dyslipidæmi, akne og pletblødning), hvorved compliance muligvis påvirkes.
English: CD4 Mean Change from Baseline, cells/mm3 All patients 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
Danish: CD4 Middelændring fra baseline, celler/mm3 Alle patienter 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
English: Four subjects in the unboosted REYATAZ group and 2 in the REYATAZ + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Danish: 4 forsøgspersoner i gruppen med ikke-boostet REYATAZ og 2 forsøgspersoner i gruppen med REYATAZ + ritonavir havde hivRNA > 500 kopier/ml i vedligeholdelsesfasen.
English: The pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV-infected patients; significant differences were observed between the two groups.
Danish: Farmakokinetik for atazanavir er evalueret hos raske, voksne frivillige og hos hiv-inficerede patienter; der er observeret væsentlige forskelle mellem de to grupper.
English: postpartuma (n=36)
Danish: Post partuma (n=36)
English: 100 mgc aEach sachet contains 50 mg of REYATAZ bRitonavir oral solution cRitonavir oral solution or capsule/tablet
Danish: 100 mgc aHvert brev indeholder 50 mg REYATAZ bRitonavir oral opløsning cRitonavir oral opløsning eller kapsler/tabletter
English: Table 8: Efficacy Outcomes for oral powder (paediatric patients at least 3 months of age and weighing at least 5 kg) at Week 48 (Studies AI424-397 and AI424-451) Parameter
Danish: Tabel 8: Effektresultater for oralt pulver (pædiatriske patienter på mindst 3 måneder og som vejer mindst 5 kg) ved uge 48 (studierne AI424-397 og AI424-451) Parameter
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of REYATAZ is based on data from the open-label, multicenter clinical trial AI424-020 conducted in patients from 3 months to 21 years of age.
Danish: Vurdering af farmakokinetik, sikkerhed, tolerabilitet og virkning af REYATAZ er baseret på data fra et åbent, klinisk multicenterstudie (AI424-020), der blev udført med patienter i alderen 3 måneder til 21 år.
English: AI424-451 (PRINCE II): In paediatric patients from 3 months to less than 11 years of age In these studies, 155 patients (59 antiretroviral-naive and 96 antiretroviral-experienced) received once daily REYATAZ oral powder and ritonavir, in combination with two NRTIs.
Danish: AI424-451 (PRINCE II): Hos pædiatriske patienter fra 3 måneder til under 11 år I disse studier fik 155 patienter (59 antiretroviral-naive og 96 antiretroviral-erfarne) en daglig dosis REYATAZ oralt pulver og ritonavir i kombination med to NRTI'er.
English: If an oral contraceptive is administered with REYATAZ/ritonavir, it is recommended that the oral contraceptive contain at least 30 μg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen.
Danish: Hvis oral kontraception administreres samtidig med REYATAZ/ritonavir, anbefales det, at det indeholder mindst 30 μg ethinylestradiol, og at patienten forstår nødvendigheden af omhyggelig compliance med dette kontraceptionsmiddel.
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between REYATAZ and comparator regimens (see section 4.4).
Danish: Hyppigheden af behandlingsrelateret hepatitis eller transaminaseforhøjelser hos samtidigt inficerede patienter var sammenlignelig mellem REYATAZ og sammenlignelige regimer (se pkt.
English: These instructions show you how to prepare and give a dose of REYATAZ oral powder.
Danish: Følgende anvisninger fortæller, hvordan du tilbereder og giver en dosis REYATAZ oralt pulver.
English: Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Danish: Hos antiretroviralt behandlingserfarne patienter fra studie 009, 043 og 045 blev 100 isolater fra patienter angivet som virologisk svigt under behandling, der omfattede enten atazanavir, atazanavir + ritonavir eller atazanavir + saquinavir og blev fastsat til at have udviklet resistens over for atazanavir,.
English: Food effect: co-administration of REYATAZ and ritonavir with food optimises the bioavailability of atazanavir.
Danish: Fødepåvirkning: samtidig indtag af REYATAZ og ritonavir og mad optimerer biotilgængeligheden af atazanavir.
English: Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows: if you have hepatitis B or C if you develop signs or symptoms of gall stones (pain at the right side of your stomach) if you have type A or B haemophilia if you require haemodialysis
Danish: Kontakt lægen eller apotekspersonalet, før du tager REYATAZ, og vær sikker på, at din læge ved det: hvis du har hepatitis B eller C hvis du får tegn eller symptomer på galdesten (smerter i højre side af maven) hvis du har type A- eller B-blødersygdom hvis du er i hæmodialysebehandling.
English: Effect on atazanavir and ritonavir exposure has not been studied.
Danish: Effekt ved eksponering af atazanavir og ritonavir er ikke blevet undersøgt.
English: Fifteen of 120 (13%) patients in the REYATAZ + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
Danish: Femten ud af 120 (13%) patienter i REYATAZ + ritonavir-behandlingsarmen og 17 ud af 123 (14%) patienter i lopinavir + ritonavir-armen havde fire eller flere af PI-substitutionerne L10, M46, I54, V82, I84 og L90.
English: REYATAZ should not be used in children less than 3 months because of safety concerns especially taking into account the potential risk of kernicterus.
Danish: REYATAZ bør ikke anvendes til børn under 3 måneder på grund af problemstillinger vedrørende sikkerhed, især på grund af den potentielle risiko for kernicterus.
English: Immunosuppressants Cyclosporin Tacrolimus Sirolimus
Danish: Ciclosporin Tacrolimus Sirolimus
English: Table 7: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Danish: Tabel 7: Effektparametre (pædiatriske patienter fra 6 år til under 18 år) ved uge 48 (AI424-020 studie)
English: No recommendation regarding dose reduction can be made; therefore, caution should be exercised if REYATAZ is coadministered with clarithromycin.
Danish: Der kan ikke gives anbefalinger vedrørende dosisreduktion; der bør derfor udvises forsigtighed, hvis REYATAZ administreres samtidig med clarithromycin.
English: The safety and efficacy of REYATAZ has not been established in patients with significant underlying liver disorders.
Danish: Sikkerhed og effekt af REYATAZ er ikke bestemt hos patienter med signifikante underliggende leverforstyrrelser.
English: - The other ingredients are aspartame (E951), sucrose and orange vanilla flavour.
Danish: - - Øvrige indholdsstoffer: aspartam (E951), saccharose og Appelsin-vaniljesmagsstof.
English: They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system.
Danish: Medicinen nedsætter mængden af hiv i kroppen og styrker derved immunforsvaret.
English: Take REYATAZ capsules with food (a meal or a substantial snack).
Danish: Tag REYATAZ sammen med mad (et måltid eller et større mellemmåltid).
English: The M184I/V substitution emerged in 5/26 REYATAZ/ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Danish: M184I/V substitution opstod hos henholdsvis 5/26 REYATAZ/ritonavir og 7/26 lopinavir/ritonavir patienter med virologisk svigt.
English: REYATAZ oral powder contains :
Danish: REYATAZ oralt pulver indeholder:
English: Place the syringe in your child's mouth towards the cheek and push the plunger down to release the medicine.
Danish: Placer sprøjten i barnets mund ind mod kinden og tryk stemplet ned for at give medicinen.
English: Add another 15 ml of the drink, mix and have the child drink the mixture.
Danish: Tilsæt yderligere 15 ml væske, rør rundt og få barnet til at drikke blandingen.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, som er behandlet med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt dødelige leverbivirkninger.
English: Co-administration with a high-fat meal did not affect the AUC of atazanavir relative to fasting conditions and the Cmax was within 11% of fasting values.
Danish: Samtidig indtag af fedtrigt måltid påvirkede ikke AUC for atazanavir i forhold til i fastende tilstand, og Cmax lå inden for 11% i forhold til fasteværdierne.
English: The mechanism of interaction between REYATAZ/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A.
Danish: Interaktionsmekanismen mellem REYATAZ/ritonavir og sofosbuvir/velpatasvir/voxilaprevir er hæmning af OATP1B, Pgp, og CYP3A.
English: Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and CYP2C19 induction.
Danish: Ritonavir kan reducere plasmakoncentrationen af phenytoin og/eller phenobarbital på grund af CYP2C9- og CYP2C19-induktion.
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when coadministered with protease inhibitors.
Danish: Selvom det ikke er undersøgt, er der risiko for en øget pravastatin- eller fluvastatineksponering ved administration sammen med proteasehæmmere.
English: Linearity/non-linearity: the pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV infected patients; significant differences were observed between the two groups.
Danish: Linearitet/non-linearitet: Farmakokinetik for atazanavir er evalueret hos raske, voksne frivillige og hos hiv-inficerede patienter; der er observeret væsentlige forskelle mellem de to grupper.
English: Patients who received REYATAZ or REYATAZ/ritonavir at any time prior to study enrollment or who had a history of treatment failure on two or more protease inhibitors, protease inhibitor resistance or evidence of pre-existing cardiac abnormalities were excluded from the trials.
Danish: Patienter, som fik REYATAZ eller REYATAZ/ritonavir på et vilkårligt tidspunkt før studieinklusion eller som havde behandlingssvigt i anamensen med to eller flere proteasehæmmere, proteasehæmmerresistens eller tegn på præeksisterende hjerteanomalier blev ekskluderet fra studierne.
English: OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
Danish: TEKST PÅ YDRE ÆSKE (BEHOLDER OG BLISTRE) OG TEKST PÅ ETIKET TIL BEHOLDER
English: During this time, postpartum patients should follow the same dose recommendation as for nonpregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Danish: I denne periode skal post partum-patienter følge de samme dosisanbefalinger som ikke-gravide, inklusive anbefalingerne for samtidig administration af lægemidler, der er kendt for at påvirke atazanavireksponeringen (se pkt.
English: No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg. the need to consider that co-administration of voriconazole and REYATAZ without ritonavir may affect atazanavir concentrations co-administration of fluticasone and REYATAZ without ritonavir may increase fluticasone concentrations relative to fluticasone given alone if an oral contraceptive is administered with REYATAZ without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol no dose adjustment of lamotrigine is required
Danish: Enkeltdosis af famotidin bør aldrig overstige 20 mg, og den totale daglige dosis af famotidin bør ikke overstige 40 mg. at det er nødvendigt at tage højde for, at samtidig administration af voriconazol og REYATAZ uden ritonavir kan påvirke koncentrationen af atazanavir samtidig administration af fluticason og REYATAZ uden ritonavir kan øge koncentrationen af fluticason i forhold til administration af fluticason alene ved samtidig administration af et oralt kontraceptivum og REYATAZ uden ritonavir, anbefales det, at det orale kontraceptivum indeholder højst 30 µg ethinylestradiol dosisjustering af lamotrigin ikke er nødvendig
English: Polyester film/Aluminum/Polyethylene sealant film sachet.
Danish: Polyesterfilm/aluminium/polyethylen brev med klæbelukning.
English: There are no pharmacokinetic data available for REYATAZ with ritonavir in patients with renal insufficiency.
Danish: Der foreligger ingen farmakokinetiske data for REYATAZ med ritonavir hos patienter med nyreinsufficiens.
English: In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic singlecell necrosis.
Danish: I toksicitetsstudier med gentagne doser på mus, rotter og hunde var atazanavirrelaterede fund generelt begrænset til leveren og omfattede generelt minimale til milde forhøjelser af serum bilirubin og leverenzymer, hepatocellulær vacuolation og hypertrofi, og kun i hunmus hepatisk enkeltcellenekrose.
English: Co-administration with REYATAZ/ritonavir has the potential to produce a decrease or, less often, an increase in INR (International Normalised Ratio).
Danish: Samtidig administration med REYATAZ/ritonavir kan potentielt reducere eller, mindre hyppigt, øge International Normaliseret Ratio (INR).
English: Overall in this study, 182 paediatric patients (81 antiretroviral-naive and 101 antiretroviral-experienced) received once daily REYATAZ (capsule or powder formulation), with or without ritonavir, in combination with two NRTIs.
Danish: Totalt fik 182 pædiatriske patienter (81 antiretroviral-naive og 101 antiretroviral-erfarne) i dette studie REYATAZ en gang dagligt (kapsler eller pulverformulering) med eller uden ritonavir, i kombination med to NRTI'er.
English: 100 mg a Ritonavir capsules, tablets or oral solution.
Danish: 100 mg a Ritonavirkapsler, tabletter eller oral opløsning.
English: Atazanavir plasma trough concentrations were approximately 2-fold higher during the postpartum period when compared to those observed historically in HIV infected non-pregnant patients.
Danish: Atazanavirs minimumkoncentration var ca. 2 gange højere i post partum perioden sammenlignet med værdierne observeret historisk hos hiv-smittede ikke-gravide patienter.
English: Atazanavir, the active substance of REYATAZ, is excreted in human milk.
Danish: Atazanavir, det aktive stof i REYATAZ, udskilles i modermælk.
English: The entire dosage of REYATAZ oral powder (mixed in the liquid infant formula, beverage or food) is administered within one hour of preparation (the mixture can be left at room stored at temperatures not above 30°C during this period).
Danish: Den hele dosis REYATAZ oralt pulver (blandet med modermælkserstatning, væske eller føde) skal administreres inden for en time efter opblanding (i dette tidsrum kan blandingen opbevares ved stuetemperatur under 30°C).
English: Your doctor should do blood tests prior you start REYATAZ and during treatment.
Danish: Din læge bør tage blodprøver før og under behandling med REYATAZ.
English: 100 mgd a The same recommendations regarding the timing and maximum doses of concomitant proton pump inhibitors and H2receptor antagonists in adults also apply to paediatric patients (see section 4.5).
Danish: 100 mgd a De samme anbefalinger for voksne vedrørende tidspunkt og maksimal dosis af samtidigt administrerede protonpumpehæmmere og H2-receptorantagonister gælder også for pædiatriske patienter (se pkt.
English: The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with REYATAZ and ritonavir.
Danish: Produktresumé for ritonavir bør kontrolleres, inden behandling med REYATAZ og ritonavir initieres.
English: When REYATAZ/ritonavir is co-administered with either phenytoin or phenobarbital, a dose adjustment of phenytoin or phenobarbital may be required.
Danish: Når REYATAZ/ritonavir administreres sammen med phenytoin eller phenobarbital, kan det være nødvendigt at justere dosis af phenytoin eller phenobarbital.
English: Administration of REYATAZ with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and Cmax by approximately 25% compared to the fasting state.
Danish: Administration af REYATAZ og ritonavir sammen med et let eller et fedtrigt måltid nedsatte variationskoefficienten for AUC og Cmax med ca. 25% sammenlignet med i fastende tilstand.
English: Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Danish: Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil og vardenafil metaboliseres af CYP3A4.
English: The use of REYATAZ may be considered during pregnancy only if the potential benefit justifies the potential risk.
Danish: Brug af REYATAZ kan overvejes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko.