FrancophonIA/ELRC3.0 huggingface dataset:
English: In animal studies, avatrombopag had no effect on male and female fertility or early embryogenesis in rats (see section 5.3).
Danish: I dyreforsøg havde avatrombopag ingen virkning på handyrs og hundyrs fertilitet eller tidlig embryogenese hos rotter (se pkt.
English: Pharmacokinetics and pharmacodynamics of avatrombopag have not been investigated in patients with severe renal impairment (CrCL < 30 mL/min, Cockcroft-Gault) including patients requiring haemodialysis.
Danish: Avatrombopags farmakokinetik og farmakodynamik er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min, Cockcroft-Gault), herunder patienter med behov for hæmodialyse.
English: 10 film-coated tablets 15 film-coated tablets
Danish: 10 filmovertrukne tabletter 15 filmovertrukne tabletter
English: Doptelet 20 mg film-coated tablets are pale yellow, round, rounded on the upper and lower side, marked with “AVA” imprinted on one side and “20” on the other.
Danish: Doptelet 20 mg filmovertrukne tabletter er bleggule, runde tabletter, som buer ud foran og bagpå og har "AVA" trykt på den ene side og "20" på den anden.
English: Should overdose occur or be suspected, Doptelet dosing should be stopped and platelet count should be carefully monitored since avatrombopag increases platelet count in a dose-dependent fashion.
Danish: I tilfælde af overdosering eller mistanke om overdosering skal dosering af Doptelet seponeres og trombocyttallet overvåges nøje, da avatrombopag øger trombocyttallet på en dosisafhængig måde.
English: Concomitant use of avatrombopag with P-gp inhibitors resulted in alterations in exposure that were not clinically significant.
Danish: Samtidig brug af avatrombopag og P-gp-hæmmere medførte ændringer i eksponeringen, som ikke var klinisk signifikante.
English: Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
Danish: Doptelet er indiceret til behandling af svær trombocytopeni hos voksne patienter med kronisk leversygdom, for hvem et invasivt indgreb er planlagt.
English: Doptelet is not recommended in pregnancy and in women who are able to have children and are not using contraception.
Danish: Doptelet frarådes under graviditeten og til kvinder, som kan blive gravide, og som ikke bruger prævention.
English: Avatrombopag is not a substrate for OATP1B1, OATP1B3, OCT2, OAT1, and OAT3.
Danish: Avatrombopag er ikke et substrat for OATP1B1, OATP1B3, OCT2, OAT1 og OAT3.
English: Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering avatrombopag with interferon preparations.
Danish: Det vides, at interferonpræparater kan reducere trombocyttallet, og der skal tages højde for dette ved samtidig administration af avatrombopag og interferonpræparater.
English: The efficacy and safety of avatrombopag for the treatment of adult patients with chronic liver disease and a platelet count ˂ 50 x 109/L who were scheduled to undergo a procedure were studied in 2 identically-designed multicenter, randomised, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2).
Danish: Avatrombopags virkning og sikkerhed ved behandling af voksne patienter med kronisk leversygdom og et trombocyttal ˂ 50 x 109/l, for hvem et indgreb var planlagt, blev undersøgt i 2 randomiserede, dobbeltblinde, placebokontrollerede fase 3-multicenterstudier med identisk design (studie 1 og studie 2).
English: Avatrombopag is a substrate for p-glycoprotein (P-gp) mediated transport, although no clinically important differences in platelet count elevations are expected when avatrombopag is co-administered with a strong P-gp inhibitor.
Danish: Avatrombopag er et substrat for p-glykoprotein (P-gp)-medieret transport.Der forventes ingen klinisk betydende forskel i trombocytstigningen, når avatrombopag administreres samtidigt med en stærk P-gp-hæmmer.
English: In Study 2, a total of 204 patients were randomised; 128 patients to the avatrombopag treatment group and 76 patients to the placebo treatment group.
Danish: I studie 2 blev i alt 204 patienter randomiseret: 128 patienter til avatrombopag-gruppen og 76 patienter til placebogruppen.
English: Avatrombopag inhibits organic anion transporter (OAT) 1 and 3 and breast cancer resistance protein (BCRP) but not organic anion transporter polypeptide (OATP) 1B1 and 1B3, and organic cation transporter (OCT) 2 in vitro.
Danish: Avatrombopag hæmmer organisk aniontransportør (OAT) 1 og 3 samt brystcancerresistensprotein (BCRP), men ikke organisk aniontransportørpolypeptid (OATP) 1B1 og 1B3 og organisk kationtransportør (OCT) 2 in vitro.
English: • Doptelet is available in 20 mg tablets.
Danish: • Doptelet fås i 20 mg tabletter.
English: Based on the known metabolic profile of avatrombopag and the fact that only 6% of the dose is excreted in urine, the likelihood of effects of renal impairment on pharmacokinetics of avatrombopag is considered to be very low (see sections 4.2 and 4.8).
Danish: På baggrund af avatrombopags kendte metaboliske profil og det faktum, at kun 6 % af dosen udskilles i urin, anses sandsynligheden for, at nedsat nyrefunktion påvirker avatrombopags farmakokinetik, for at være meget lille (se pkt.
English: However, there was a significant reduction (by approximately 50%) in the between- and within-subject variability of avatrombopag AUC and Cmax when administered with food (see sections 4.2 and 4.5).
Danish: Der var dog en signifikant reduktion (på ca. 50 %) i den inter- og intraindividuelle variabilitet af avatrombopags AUC og Cmax ved administration sammen med mad (se pkt.
English: Avatrombopag is an orally active, small molecule thrombopoietin (TPO) receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in increased production of platelets.
Danish: Avatrombopag er en oralt aktiv, lavmolekylær trombopoietin (TPO)-receptoragonist, som stimulerer proliferation og differentiering af megakaryocytter fra progenitorceller i knoglemarven, hvilket medfører øget produktion af trombocytter.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Doptelet in all subsets of the paediatric population in thrombocytopenia secondary to liver disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Doptelet i alle undergrupper af den pædiatriske population ved trombocytopeni sekundært til leversygdom (se pkt.
English: Patients with Child Pugh class C liver disease, should be evaluated on the day of the procedure for an unexpectedly high increase in platelet count.
Danish: Patienter med Child-Pugh-klasse C-leversygdom skal evalueres for en uventet høj stigning i trombocyttallet på dagen for indgrebet.
English: The safety of avatrombopag was evaluated in two randomised, double-blind, placebo-controlled trials, Study 1 and Study 2, in which 430 patients with chronic liver disease and thrombocytopenia received either avatrombopag (n = 274) or placebo (n = 156), and had 1 post-dose safety assessment.
Danish: Avatrombopags sikkerhed blev evalueret i to randomiserede, dobbeltblindede, placebokontrollerede forsøg, studie 1 og studie 2, hvor 430 patienter med kronisk leversygdom og trombocytopeni fik enten avatrombopag (n = 274) eller placebo (n = 156), og fik foretaget 1 sikkerhedsvurdering efter dosering.
English: In each study, patients were assigned to the low baseline platelet count cohort (˂ 40 x 109/L) or the high baseline platelet count cohort (≥ 40 to ˂ 50 x 109/L) based on their platelet count at baseline.
Danish: I hvert studie blev patienterne randomiseret til kohorten med lavt trombocyttal ved baseline (˂ 40 x 109/l) eller kohorten med højt trombocyttal ved baseline (≥ 40 til ˂ 50 x 109/l) på baggrund af deres trombocyttal ved baseline.
English: However, administration of avatrombopag with both a high- and low-fat meal reduced inter-subject and intra-subject pharmacokinetic variability of avatrombopag by approximately 50%.
Danish: Administration af avatrombopag med både et måltid med højt og lavt fedtindhold reducerede dog avatrombopags inter- og intraindividuelle farmakokinetiske variabilitet med ca. 50 %.
English: Doptelet is used in adults with chronic liver disease to treat low platelet count (called thrombocytopenia) before having a medical procedure where there is a risk of bleeding.
Danish: Doptelet bruges til voksne med kronisk leversygdom til at behandle et lavt antal blodplader (lavt trombocyttal, trombocytopeni), inden de skal have udført et indgreb, hvor der er risiko for blødning.
English: In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n = 1/430) with chronic liver disease and thrombocytopenia which was reported 14 days after treatment with Doptelet ended.
Danish: I de kliniske forsøg ADAPT-1 og ADAPT-2 var der 1 bivirkning i forbindelse med behandlingen i form af portvenetrombose hos en patient (n = 1/430) med kronisk leversygdom og trombocytopeni, som blev rapporteret 14 dage efter afslutning af behandlingen med Doptelet.
English: Avatrombopag did not affect fertility or early embryonic development in male rats at exposures 22-times, or in female rats at exposures 114-times, the AUC observed in patients at the recommended dose of 60 mg once daily.
Danish: Avatrombopag påvirkede ikke fertiliteten eller den tidlige embryoniske udvikling ved eksponeringer hos han- og hunrotter, der var henholdsvis 22 gange og 114 gange højere end det AUC, der blev observeret hos patienter, som fik den anbefalede dosis på 60 mg en gang dagligt.
English: No clinically important difference in avatrombopag exposures were observed between patients with Child-Turcotte-Pugh Scores (Range = 5 to 12) or MELD scores (Range = 4 to 23) and healthy subjects.
Danish: Der blev ikke observeret klinisk vigtige forskelle i avatrombopag-eksponeringen mellem patienter med Child-Turcotte-Pugh-scorer (interval = 5 til 12) eller MELD-scorer (interval = 4 til 23) og raske forsøgsdeltagere.
English: Open label, randomised, cross-over replicate design clinical trials were conducted in healthy subjects to assess the effects of high-fat and low-fat food on the bioavailability and pharmacokinetic variability of avatrombopag.
Danish: Der blev gennemført åbne, randomiserede kliniske forsøg med cross-over-replikatdesign med raske forsøgsdeltagere for at vurdere virkningerne af fødevarer med højt og lavt fedtindhold på avatrombopags biotilgængelighed og farmakokinetiske variabilitet.
English: Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag.
Danish: En filmovertrukket tablet indeholder avatrombopagmaleat svarende til 20 mg avatrombopag.
English: Other medicines and Doptelet
Danish: Brug af anden medicin sammen med Doptelet
English: Avatrombopag was present in the milk of lactating rats, see section 5.3.
Danish: Avatrombopag var til stede i mælken hos diegivende rotter; se pkt.
English: Thrombotic/thromboembolic events
Danish: Trombotiske/tromboemboliske hændelser
English: The most important treatment-emergent adverse reaction associated with avatrombopag was portal vein thrombosis.
Danish: Den vigtigste bivirkning i forbindelse med behandlingen, som var forbundet med avatrombopag, var portvenetrombose.
English: In these species, avatrombopag was associated with histopathologic changes in the fundic mucosa of the glandular stomach, characterised by degeneration of the glandular epithelium with a decrease in matured parietal cells.
Danish: Hos disse arter var avatrombopag forbundet med histopatologiske ændringer i fundusslimhinden i kirtelmaven, der er kendetegnet ved degeneration af kirtelepitelet med et fald i modne parietalceller.
English: Co-administration of avatrombopag with either a high-fat or low-fat meal did not result in clinically important changes in rate or extent of absorption of avatrombopag.
Danish: Samtidig administration af avatrombopag og et måltid med enten højt eller lavt fedtindhold medførte ikke klinisk vigtige ændringer i hastigheden eller omfanget af absorption af avatrombopag.
English: No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let (Child-Pugh-klasse A) eller moderat (Child-Pugh-klasse B) nedsat leverfunktion.
English: The apparent volume of distribution of avatrombopag in patients with thrombocytopenia and chronic liver disease based on population pharmacokinetic analysis is approximately 180 L, suggesting that avatrombopag is extensively distributed.
Danish: Avatrombopags tilsyneladende fordelingsvolumen hos patienter med trombocytopeni og kronisk leversygdom baseret på farmakokinetisk populationsanalyse er omtrent 180 l, hvilket tyder på, at avatrombopags fordeling er ekstensiv.
English: The primary toxicity of avatrombopag in pivotal repeated-dose studies was in the stomach at high doses with adequate safety margins when compared to the exposure at the maximum recommended human dose; these effects were reversible even in the chronic toxicity studies.
Danish: Avatrombopags primære toksicitet i pivotale studier med gentagne doser fandtes i mavesækken ved høje doser med tilstrækkelige sikkerhedsmargener sammenlignet med eksponeringen ved den maksimalt anbefalede humane dosis.
English: A population pharmacokinetic analysis evaluated avatrombopag plasma exposures in patients with mild to moderate hepatic impairment based on Model for End-Stage Liver Disease (MELD) scores and Child-Turcotte-Pugh scores.
Danish: En farmakokinetisk populationsanalyse evaluerede avatrombopag-plasmaeksponeringer hos patienter med let til moderat nedsat leverfunktion baseret på MELD-scorer (Model for End-Stage Liver Disease) og Child-Turcotte-Pugh-scorer.
English: However, these patients should be evaluated on the day of the procedure for an unexpectedly high increase in platelet count (see section 4.2 and 5.2).
Danish: Disse patienter skal dog evalueres for uventet høj stigning i trombocyttallet på dagen for indgrebet (se pkt.
English: Each carton contains one blister of 10 or 15 film-coated tablets.
Danish: En æske indeholder én blister med 10 eller 15 filmovertrukne tabletter.
English: Contains lactose, see leaflet for further information.
Danish: Se indlægssedlen for at få yderligere oplysninger.
English: Avatrombopag should only be used in such patients if the expected benefit outweighs the expected risks (see sections 4.2 and 5.2).
Danish: Avatrombopag bør kun bruges til disse patienter, hvis den forventede fordel opvejer de forventede risici (se pkt.
English: Obtain a platelet count prior to the administration of Doptelet therapy and on the day of a procedure to ensure an adequate increase in platelet count, and no unexpectedly high increase in platelet count in the patient populations specified in sections 4.4 and 4.5.
Danish: Der skal indhentes trombocyttal inden administration af behandling med Doptelet samt på dagen for indgrebet for at sikre en tilstrækkelig stigning i trombocyttallet og fravær af en uventet høj stigning i trombocyttallet hos de patientpopulationer, der er beskrevet i pkt.
English: • blood clot in the portal vein (blood vessel that carries blood to the liver from the intestines)
Danish: • blodprop i portvenen (et blodkar, der fører blod til leveren fra tarmene), hvilket kan medføre smerter eller hævelser i den øverste del af maven
English: There is limited information on the use of avatrombopag in patients with severe (Child-Pugh class C, MELD score > 24) hepatic impairment.
Danish: Der foreligger begrænsede oplysninger om brugen af avatrombopag hos patienter med svært (Child-Pugh-klasse C, MELD-score > 24) nedsat leverfunktion.
English: Population pharmacokinetic analysis of avatrombopag plasma concentrations from clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease, that included 11% (84/787) of the study population ≥ 65 years of age, suggested that avatrombopag exposures are not affected by age (see section 4.2).
Danish: En farmakokinetisk populationsanalyse af plasmakoncentrationer af avatrombopag fra kliniske studier med raske forsøgsdeltagere og patienter med trombocytopeni som følge af kronisk leversygdom, som omfattede 11 % (84/787) af studiepopulationen ≥ 65 år, tyder på, at eksponering for avatrombopag ikke påvirkes af alder (se pkt.
English: Avatrombopag 40 mg (n = 58) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec a Two-sided 95% confidence interval based on normal approximation.
Danish: Avatrombopag 40 mg (n = 58) Andel af forsøgsdeltagere, som ikke havde behov for trombocyttransfusion eller nødprocedure i forbindelse med blødning Respondere 95 % CIa P-værdib Andel af forsøgsdeltagere, som opnåede et trombocyttal ≥ 50 × 109/l på dagen for indgrebet Respondere 95 % CIa P-værdib Ændring i trombocyttal fra baseline til dagen for indgrebet Middel (SD) x 109/l Median x 109/l P-værdic a Tosidet 95 % konfidensinterval baseret pånormalfordelingstilnærmelse.
English: Lactose monohydrate Microcrystalline cellulose (E460(i)) Crospovidone type B (E1202) Silica, colloidal anhydrous (E551) Magnesium stearate (E470b)
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose (E460(i)) Crospovidon type B (E1202) Silica, kolloid vandfri (E551) Magnesiumstearat (E470b)
English: Avatrombopag 60 mg (n = 70) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec
Danish: Avatrombopag 60 mg (n = 70) Andel af forsøgsdeltagere, som ikke havde behov for trombocyttransfusion eller nødprocedure i forbindelse med blødning Respondere 95 % CIa P-værdib Andel af forsøgsdeltagere, som opnåede et trombocyttal ≥ 50 × 109/l på dagen for indgrebet Respondere 95 % CIa P-værdib Ændring i trombocyttal fra baseline til dagen for indgrebet Middel (SD) x 109/l Median x 109/l P-værdic
English: Table 2: Efficacy results by baseline platelet count cohort and treatment group - Study 1 and Study 2
Danish: kohorte efter trombocyttal ved baseline og behandlingsgruppe - studie 1 og studie 2
English: 40 mg (Two 20 mg tablets)
Danish: 40 mg (to 20 mg tabletter)
English: Tablet core: lactose monohydrate (see section 2 “Doptelet contains lactose”); microcrystalline cellulose [E460(i)]; crospovidone type B [E1202]; silica, colloidal anhydrous [E551]; magnesium stearate [E470b].
Danish: Tabletkerne: lactosemonohydrat (se afsnit 2, "Doptelet indeholder lactose"); mikrokrystallinsk cellulose [E460(i)]; crospovidon type B [E1202]; silica, kolloid vandfri [E551]; magnesiumstearat [E470b].
English: Concomitant use of avatrombopag with strong CYP3A4/5 or CYP2C9 inhibitors increases avatrombopag exposure.
Danish: Samtidig brug af avatrombopag og stærke CYP3A4/5- eller CYP2C9-hæmmere øger eksponeringen for avatrombopag.
English: Avatrombopag was not mutagenic in an in vitro bacterial reverse mutation (AMES) assay or clastogenic in an in vitro human lymphocyte chromosomal aberrations assay or in an in vivo rat bone marrow micronucleus assay.
Danish: Avatrombopag var ikke mutagent i en in vitro-analyse af bakteriel tilbagemutation (AMES) eller klastogent i en in vitro-analyse af humane lymfocytkromosomafvigelser eller i en in vivo-mikronukleusanalyse af knoglemarv hos rotter.
English: Due to limited information available, the safety and efficacy of avatrombopag in patients with severe hepatic impairment (Child-Pugh class C, MELD score > 24) have not been established (see section 4.4).
Danish: Da der foreligger begrænsede data, er avatrombopags sikkerhed og virkning hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C, MELD-score > 24) ikke klarlagt (se pkt.
English: The population pharmacokinetic analysis of avatrombopag in healthy subjects and subjects with thrombocytopenia due to chronic liver disease indicated similar exposures between healthy subjects and subjects with mild and moderate renal impairment (CrCL ≥ 30 mL/min, Cockcroft-Gault).
Danish: Den farmakokinetiske populationsanalyse af avatrombopag hos raske forsøgsdeltagere og forsøgsdeltagere med trombocytopeni som følge af kronisk leversygdom indikerede lignende eksponeringer mellem raske forsøgsdeltagere og forsøgsdeltagere med let og moderat nedsat nyrefunktion (CrCl ≥ 30 ml/min, Cockcroft-Gault).
English: Portal vein thrombosis has been reported at an increased frequency in patients with chronic liver disease who had platelet counts > 200 x 109/L receiving a thrombopoietin receptor agonist (see section 4.8).
Danish: Der er rapporteret portvenetrombose med øget hyppighed hos patienter med kronisk leversygdom, som havde trombocyttal > 200 x 109/l, og som fik en trombopoietinreceptoragonist (se pkt.
English: If you are breast-feeding, ask your doctor or pharmacist for advice before taking Doptelet.
Danish: Hvis du ammer, skal du spørge lægen eller apotekspersonalet til råds, inden du tager Doptelet.
English: Portal vein thrombosis
Danish: Portvenetrombose
English: Each film-coated tablet contains 120.8 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på En filmovertrukket tablet indeholder 120,8 mg lactosemonohydrat.
English: P-gp inhibitor
Danish: P-gp-hæmmer
English: Film coating: poly(vinyl alcohol) [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; iron oxide yellow [E172].
Danish: Filmovertræk: polyvinylalkohol [E1203]; talcum [E553b]; macrogol 3350 [E1521]; titandioxid [E171]; gul jernoxid [E172].
English: • Your dose will depend on your platelet counts.
Danish: • Din dosis afhænger af antallet af blodplader i dit blod (dit trombocyttal).
English: Avatrombopag therapy should only be initiated in patients with severe hepatic impairment if the expected benefit outweighs the expected risks (see sections 4.4 and 5.2).
Danish: Behandling med avatrombopag bør kun indledes hos patienter med svært nedsat leverfunktion, hvis den forventede fordel opvejer de forventede risici (se pkt.
English: Low baseline platelet count cohort (< 40 x 109/L)
Danish: Kohorte med lavt trombocyttal ved baseline (< 40 x 109/l)
English: High baseline platelet count (≥ 40 to < 50 x 109/L)
Danish: Kohorte med højt trombocyttal ved baseline (≥ 40 til < 50 x 109/l)
English: Concomitant use of strong CYP3A4/5 or CYP2C9 inducers reduces avatrombopag exposure, and may result in a decreased effect on platelet counts; however, no dose adjustment is recommended (see section 5.2).
Danish: Samtidig brug af stærke CYP3A4/5- eller CYP2C9-induktorer reducerer eksponeringen for avatrombopag og kan medføre en nedsat virkning på trombocyttallet.
English: Strong CYP3A4/5 or CYP2C9 inducers
Danish: Stærke CYP3A4/5- eller CYP2C9-induktorer
English: Population pharmacokinetic analysis of avatrombopag plasma concentrations from the clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease indicated that avatrombopag exposures were similar across the different races studied.
Danish: En farmakokinetisk populationsanalyse af plasmakoncentrationer af avatrombopag fra de kliniske studier med raske forsøgsdeltagere og patienter med trombocytopeni som følge af kronisk leversygdom indikerede, at eksponering for avatrombopag var ens på tværs af de forskellige undersøgte racer.
English: Doptelet is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Doptelet bør ikke anvendes under graviditeten og til fertile kvinder, som ikke anvender sikker kontraception.
English: Moderate CYP2C9 and strong CYP3A inducer
Danish: Moderat CYP2C9- og stærk CYP3A-induktor