FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypergastrinemia-related gastric carcinoids in rodents are generally considered to be of low risk or relevance to humans.
Danish: Hypergastrinæmi-relaterede gastriske karcinoider hos gnavere anses generelt for at have lav risiko eller relevans for mennesker.
English: There is no specific antidote for overdose with avatrombopag.
Danish: Der er ingen specifik antidot mod en overdosis af avatrombopag.
English: Doptelet is for oral use, and the tablets should be taken once daily with food (see section 5.2).
Danish: Doptelet er til oral anvendelse, og tabletterne skal tages en gang dagligt sammen med mad (se pkt.
English: The effect of avatrombopag on human fertility has not been established.
Danish: Avatrombopags virkning på human fertilitet er ikke klarlagt.
English: It belongs to a group of medicines called thrombopoietin receptor agonists.
Danish: Det tilhører en gruppe lægemidler, der kaldes trombopoietin-receptor-agonister.
English: There is limited information on the use of avatrombopag in patients previously exposed to avatrombopag.
Danish: Der foreligger begrænsede oplysninger om brugen af avatrombopag hos patienter, som tidligere er blevet eksponeret for avatrombopag.
English: Responders were defined as patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomisation and up to 7 days following a scheduled procedure.
Danish: Respondere blev defineret som patienter, som ikke havde behov for trombocyttransfusion eller en nødprocedure i forbindelse med blødning efter randomisering og op til 7 dage efter et planlagt indgreb.
English: This effect was not associated with inflammatory response or any evidence of erosion or ulcer formation.
Danish: Denne virkning var ikke forbundet med inflammatorisk respons eller tegn på erosion eller sårdannelse.
English: • Swallow the tablets whole, once daily with food.
Danish: • Tabletterne skal synkes hele, tages en gang om dagen og indtages sammen med mad.
English: Animal Toxicology and/or Pharmacology
Danish: Toksikologi og/eller farmakologi i dyr
English: Following administration of a single 20 mg 14C-avatrombopag dose to healthy male volunteers, 88% of the dose was recovered in faeces and 6% in urine.
Danish: Efter administration an en enkelt dosis på 20 mg 14C-avatrombopag til raske frivillige mænd blev 88 % af dosen genfundet i fæces og 6 % i urin.
English: Avatrombopag is a substrate for P-glycoprotein (P-gp) mediated transport (see Table 3).
Danish: Avatrombopag er et substrat for P-glykoprotein (P-gp)-medieret transport (se tabel 3).
English: What you need to know before you take Doptelet 3.
Danish: Det skal du vide, før du begynder at tage Doptelet 3.
English: Do not stop taking Doptelet unless your doctor tells you to.
Danish: Du må ikke holde op med at tage Doptelet, medmindre lægen beder dig om det.
English: Common (may affect up to 1 in 10 people) • feeling tired
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) • træthed
English: Co-administered drug*
Danish: Samtidigt administreret lægemiddel*
English: You may be at higher risk of blood clots as you get older or if: - you have had to stay in bed for a long time - you have cancer - you are taking the contraceptive birth control pill or hormone replacement therapy - you have recently had surgery or been injured
Danish: Du kan have højere risiko for at få blodpropper med alderen, eller hvis: - du har været sengeliggende igennem længere tid - du har kræft - du tager p-piller eller får hormonbehandling - du er blevet opereret eller er kommet til skade for nylig
English: Patients' MELD scores ranged from < 10 (37.5%), 10 to 14 (46.3%) and from > 14 to < 24 (16.2%), and included patients with CTP Class A (56.4%), Class B (38.1%), and Class C (5.6%).
Danish: Patienternes MELD-scorer lå i intervallet < 10 (37,5 %), fra 10 til 14 (46,3 %) og fra > 14 til < 24 (16,2 %) og omfattede patienter med CTP klasse A (56,4 %), klasse B (38,1 %) og klasse C (5,6 %).
English: The gastric carcinoids were considered likely due to prolonged hypergastrinemia observed in toxicity studies.
Danish: De gastriske karcinoider blev anset for sandsynligvis at skyldes længerevarende hypergastrinæmi, som blev observeret i toksicitetsstudier.
English: The severity of gastric lesions was dependent on the dose and duration of avatrombopag administration and showed a clear trend towards reversibility during the recovery period.
Danish: De gastriske læsioners sværhedsgrad afhang af dosis og varighed af administration af avatrombopag og viste en klar tendens mod reversibilitet i restitutionsperioden.
English: The efficacy of avatrombopag was similar across various subgroups for the pooled Phase 3 study population (Study 1 and Study 2).
Danish: Avatrombopags virkning var ens i de forskellige undergrupper i den samlede fase 3-studiepopulation (studie 1 og studie 2).
English: Doptelet is not expected to affect you being able to drive, cycle or use tools or machines.
Danish: Doptelet forventes ikke at påvirke din evne til at føre motorkøretøj eller cykel eller til at bruge værktøj og maskiner.
English: Elderly No dose adjustment is required for patients aged 65 years and older (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis hos patienter i alderen 65 år og ældre (se pkt.
English: The mean plasma elimination half-life (%CV) of avatrombopag is approximately 19 hours (19%).
Danish: Avatrombopags gennemsnitlige plasmaeliminationshalveringstid (%CV) er ca. 19 timer (19 %).
English: No metabolites of avatrombopag were detected in plasma.
Danish: Der blev ikke påvist nogen metabolitter af avatrombopag i plasma.
English: Blister (polyamide and polyvinyl chloride-laminated aluminium film with push-through aluminium and polyethylene terephthalate foil) containing either 10 or 15 film-coated tablets.
Danish: Blister (polyamid og polyvinylchlorid-lamineret aluminiumsfilm med perforerbar aluminiums- og polyethylentereftalatfolie) med enten 10 eller 15 filmovertrukne tabletter.
English: The patient should undergo their procedure 5 to 8 days after the last dose of avatrombopag.
Danish: Patienten skal have indgrebet foretaget 5 til 8 dage efter den sidste dosis avatrombopag.
English: Each blister contains either 10 or 15 tablets.
Danish: En blister indeholder enten 10 eller 15 tabletter.
English: Your doctor will help you decide whether the benefit of breast-feeding outweighs any possible risks to your baby while you are breast-feeding.
Danish: Din læge vil hjælpe dig med at beslutte, om fordelene ved amning opvejer eventuelle risici for dit barn, mens du ammer.
English: Human studies demonstrated that the renal route is not a major pathway for either unchanged avatrombopag or its metabolite's elimination.
Danish: Studier med mennesker påviste, at nyrerne ikke er en vigtig eliminationsvej for hverken uændret avatrombopag eller dets metabolitter.
English: The recommended daily dose of avatrombopag is based on the patient's platelet count (see Table 1).
Danish: Den anbefalede daglige dosis avatrombopag er baseret på patientens trombocyttal (se tabel 1).
English: What you need to know before you take Doptelet Do not take Doptelet if:
Danish: Det skal du vide, før du begynder at tage Doptelet Tag ikke Doptelet:
English: Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX08
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, andre systemiske hæmostatika, ATC-kode: B02BX08
English: Avatrombopag was present in milk of lactating rats after oral administration of radioactive labeled avatrombopag.
Danish: Avatrombopag fandtes i mælken hos diegivende rotter efter oral administration af radioaktivt mærket avatrombopag.
English: Therefore, data from these animal studies do not fully model potential adverse effects related to platelet count increases due to avatrombopag in humans.
Danish: Derfor modellerer data fra disse dyreforsøg ikke fuldt ud potentielle bivirkninger relateret til stigninger i trombocyttal som følge af administration af avatrombopag til mennesker.
English: Avatrombopag does not stimulate platelet production in mice, rats, monkeys, or dogs because of the unique TPO receptor specificity.
Danish: Avatrombopag stimulerer ikke produktion af trombocytter hos mus, rotter, aber eller hunde på grund af den unikke TPO-receptorspecificitet.
English: Table 3: Drug interactions: Changes in pharmacokinetics of avatrombopag in the presence of co-administered drug
Danish: Tabel 3: Lægemiddelinteraktioner: Ændringer i avatrombopags farmakokinetik ved tilstedeværelse af et samtidigt administreret lægemiddel
English: Package leaflet: Information for the patient Doptelet 20 mg film-coated tablets avatrombopag This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Doptelet 20 mg filmovertrukne tabletter avatrombopag Dette lægemiddel er underlagt supplerende overvågning.
English: The exposures (AUC) at doses that showed no gastric lesions across the species were 3- to 33-fold higher than the exposures in humans at the maximum recommended human dose (MRHD).
Danish: Eksponeringen (AUC) ved doser, som ikke viste gastriske læsioner i nogen arter, var 3 til 33 gange højere end eksponeringen hos mennesker ved den maksimalt anbefalede dosis til mennesker (MRHD).
English: Effect of avatrombopag
Danish: Avatrombopags virkning
English: It is unknown whether avatrombopag or its metabolites are excreted in human milk.
Danish: Det er ukendt, om avatrombopag/metabolitter udskilles i human mælk.
English: Avatrombopag demonstrated dose-proportional pharmacokinetics after single doses from 10 mg (0.25-times the lowest approved dosage) to 80 mg (1.3-times the highest recommended dosage).
Danish: Avatrombopag udviste dosisproportional farmakokinetik efter enkelte doser fra 10 mg (0,25 gange den laveste godkendte dosis) til 80 mg (1,3 gange den højeste anbefalede dosis).
English: Patients were then randomised 2:1 to either avatrombopag or placebo.
Danish: Patienterne blev derefter randomiseret 2:1 til at få enten avatrombopag eller placebo.
English: The mean (%CV) of the clearance of avatrombopag is estimated to be 6.9 L/hr (29%).
Danish: Avatrombopags middelclearance (%CV) anslås at være 6,9 l/t (29 %).
English: The tablets are supplied in cartons containing one aluminium blister.
Danish: Tabletterne udleveres i æsker med én aluminiumsblister.
English: • low red blood cell count (anaemia)
Danish: • lavt antal røde blodlegemer (blodmangel/anæmi)
English: Doptelet has no or negligible influence on the ability to drive and use machines.
Danish: Doptelet påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Talk to your doctor or pharmacist before taking Doptelet if: - you are at risk of blood clots in your veins or arteries, or members of your family have had blood clots.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Doptelet, hvis: - du har risiko for blodpropper i dine blodårer, eller hvis nogen i din familie har haft en blodprop.
English: In a multiple-dose pharmacokinetic study in healthy volunteers, steady state was reached by day 5 of dosing.
Danish: I et farmakokinetisk studie med flere doser administreret til raske frivillige blev steady state nået på dag 5 med dosering.
English: Doptelet contains lactose
Danish: Doptelet indeholder lactose
English: Eligible patients were scheduled to undergo their procedure (low bleeding risk procedures, such as endoscopy and colonoscopy (60.8%); moderate bleeding risk, such as liver biopsy and chemoembolization for HCC (17.2%); or high bleeding risk, such as dental procedures and radiofrequency ablation (22.1%)) 5 to 8 days after their last dose of treatment.
Danish: Egnede patienter fik deres indgreb planlagt (indgreb med lav blødningsrisiko som for eksempel endoskopi og koloskopi (60,8 %), moderat blødningsrisiko som for eksempel leverbiopsi og kemoembolisering for HCC (17,2 %) eller høj blødningsrisiko som for eksempel tandbehandlinger og radiofrekvensablation (22,1 %) 5 til 8 dage efter deres sidste dosis af behandlingen.
English: Patient populations were similar between the low and high baseline platelet count cohorts, and consisted of 66% male and 35% female; median age 58 years and 61% White, 34% Asian, and 3% Black.
Danish: Patientpopulationerne i kohorterne med lavt og højt trombocyttal ved baseline var ens og bestod af 66 % mænd og 35 % kvinder, medianalderen var 58 år, og 61 % var hvide, 34 % var asiater og 3 % var sorte.
English: Dosing should begin 10 to 13 days prior to the planned procedure.
Danish: Doseringen skal påbegyndes 10 til 13 dage inden det planlagte indgreb.
English: The safety and efficacy of avatrombopag in children aged less than 18 years have not been established.
Danish: Pædiatrisk population Avatrombopags sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Patients with chronic liver disease are known to be at increased risk for thromboembolic events.
Danish: Patienter med kronisk leversygdom vides at have øget risiko for tromboemboliske hændelser.
English: Consider the potential increased thrombotic risk when administering Doptelet to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).
Danish: Den potentielt øgede risiko for trombose skal overvejes ved administration af Doptelet til patienter med kendte risikofaktorer for tromboemboli, herunder genetiske protrombotiske tilstande (faktor V Leiden, protrombin 20210A, antitrombinmangel eller protein C- eller S-mangel).
English: While the benefit-risk profile for procedures that were not specifically included in the clinical studies is likely to be comparable, the efficacy and safety of avatrombopag have not been established in major surgeries like laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.
Danish: Benefit-risk-profilen for indgreb, som ikke specifikt var medtaget i de kliniske studier, er sandsynligvis sammenlignelig, men avatrombopags virkning og sikkerhed er ikke blevet fastlagt ved større operationer som for eksempel laparotomi, torakotomi, åben hjertekirurgi, kraniotomi eller ekscision af organer.
English: Therefore, avatrombopag is recommended to be administered with food (see section 4.2).
Danish: Det anbefales derfor, at avatrombopag administreres sammen med mad (se pkt.
English: Two doses should not be taken at one time to make up for a missed dose.
Danish: Der bør ikke tages to doser samtidigt som kompensation for en glemt dosis.
English: Reproductive and Developmental Toxicity
Danish: Reproduktions- og udviklingstoksicitet
English: You should be scheduled to undergo your procedure 5 to 8 days after the last dose of Doptelet.
Danish: Dit indgreb skal være planlagt til at blive udført 5 til 8 dage efter den sidste dosis Doptelet.
English: Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.
Danish: Avatrombopag konkurrerer ikke med TPO om binding til TPO-receptoren og har en additiv virkning med TPO på trombocytproduktionen.
English: The pharmacokinetic parameters of avatrombopag in milk were similar to those in plasma with an exposure ratio of avatrombopag-related radioactivity (milk to plasma) of 0.94.
Danish: De farmakokinetiske parametre for avatrombopag i mælk svarede til dem i plasma, med et eksponeringsforhold for avatrombopag-relateret radioaktivitet (mælk til plasma) på 0,94.
English: Avatrombopag does not inhibit CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A, does not induce CYP1A, CYP2B6, CYP2C, and CYP3A, and weakly induces CYP2C8 and CYP2C9 in vitro.
Danish: Avatrombopag hæmmer ikke CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A, inducerer ikke CYP1A, CYP2B6, CYP2C og CYP3A og inducerer CYP2C8 og CYP2C9 svagt in vitro.
English: Doptelet was not studied in patients with prior thromboembolic events.
Danish: Doptelet er ikke undersøgt hos patienter med tidligere tromboemboliske hændelser.
English: • fever
Danish: • feber.
English: The proportion of subjects not requiring a platelet transfusion or any rescue procedure for bleeding was generally similar across the various subgroups.
Danish: Andelen af forsøgsdeltagere, som ikke havde behov for trombocyttransfusion eller en nødprocedure i forbindelse med blødning var stort set ens i de forskellige undergrupper.
English: Doptelet contains an active substance called avatrombopag.
Danish: Doptelet indeholder et aktivt stof, der kaldes avatrombopag.
English: Due to the limited information available, avatrombopag should only be used in Child-Pugh class C patients when the expected benefit outweighs the expected risks.
Danish: Da der foreligger begrænsede oplysninger, bør avatrombopag kun bruges hos patienter med Child-Pugh-klasse C, hvis de forventede fordele opvejer de forventede risici.
English: Administration with either type of food did not have any clinically important effects on rate (Cmax) or extent (AUC) of avatrombopag exposure.
Danish: Administration sammen med mad, uanset type, havde ingen klinisk vigtige virkninger på hastigheden (Cmax) eller omfanget (AUC) af eksponering for avatrombopag.
English: Geometric mean ratio [90% CI] of avatrombopag PK with/without co administered drug (No Effect = 1.00)
Danish: Geometrisk middelratio [90 % CI] for avatrombopags farmakokinetik med/uden et samtidigt administreret lægemiddel (ingen virkning = 1,00)
English: Table 1 Daily dose recommendation for avatrombopag
Danish: Tabel 1 Anbefaling om daglig dosis for avatrombopag
English: Patients with severe hepatic impairment should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.
Danish: Patienter med svært nedsat leverfunktion skal have understøttende behandling i overensstemmelse med klinisk praksis i form af nøje overvågning for tidlige tegn på forværret eller nyt udbrud af hepatisk encefalopati, ascites og tendens til trombose eller blødning ved hjælp af overvågning af leverfunktionstests, tests anvendt til at vurdere koagulationsstatus samt billeddannelse af portvaskulatur efter behov.
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister after ‘EXP'.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen og hvert blisterkort efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Use in patients with chronic liver disease undergoing invasive procedures The objective of treatment with Doptelet is to increase platelet counts.
Danish: Anvendelse til patienter med kronisk leversygdom, som skal have foretaget invasive indgreb Formålet med behandling med Doptelet er at øge trombocyttallet.
English: If you stop taking Doptelet
Danish: Hvis du holder op med at tage Doptelet
English: The increase in avatrombopag exposure is not expected to have a clinically important effect on platelet counts due to the 5-day treatment duration, and no dose adjustment is recommended.
Danish: Stigningen i eksponeringen for avatrombopag forventes ikke at have klinisk betydningsfuld virkning på trombocyttallet, da behandlingen kun varer 5 dage, og der er ingen anbefalinger om dosisjustering.
English: In 4-week or longer repeated-dose toxicity studies, treatment-related gastric lesions were observed in mice, rats, and cynomolgus monkeys.
Danish: I toksicitetsstudier med gentagne doser med en varighed på 4 uger eller længere blev der observeret behandlingsrelaterede gastriske læsioner hos mus, rotter og cynomolgusaber.
English: The oxidative metabolism of avatrombopag is mainly mediated by CYP2C9 and CYP3A4.
Danish: Avatrombopags oxidative metabolisme medieres hovedsagelig via CYP2C9 og CYP3A4.
English: Doptelet should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.
Danish: Doptelet bør ikke administreres til patienter med kronisk leversygdom som forsøg på at normalisere trombocyttallet.
English: In two-year carcinogenicity studies in mice and rats, neuroendocrine cell (enterochromaffin-like cell, ECL cell) gastric tumours (carcinoids) occurred in the stomach at high doses.
Danish: I toårige karcinogenicitetsstudier med mus og rotter opstod der gastriske neuroendokrincelletumorer (enterokromaffin-lignende celler, ECL-celler) (karcinoider) i mavesækken ved høje doser.
English: Platelet count (x109/L)
Danish: Trombocyttal (x109/l)
English: The plasma concentration-time profiles following the oral administration of avatrombopag were characterised by a short lag time (0.5 - 0.75 hours) with peak exposure at 6 - 8 hours post dose.
Danish: Plasmakoncentrationstidskurven efter oral administration af avatrombopag var kendetegnet ved en kort latenstid (0,5 - 0,75 timer) med højeste eksponering 6 - 8 timer efter administration.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Doptelet therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Doptelet seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Avatrombopag is not renally excreted, therefore no dose adjustment is required in patients with mild or moderate renal impairment.
Danish: Avatrombopag udskilles ikke via nyrerne, og derfor er det ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat nyrefunktion.
English: Based on in vitro studies, no other transporting proteins (OATP1B1, OATP1B3, OCT2, OAT1, and OAT3) are expected to play a significant role in the disposition of avatrombopag.
Danish: På baggrund af in vitro-studier forventes ingen andre transportproteiner (OATP1B1, OATP1B3, OCT2, OAT1 og OAT3) at spille en signifikant rolle i omsætningen af avatrombopag.
English: - The active substance is avatrombopag.
Danish: - Aktivt stof: avatrombopag.
English: In Study 1, a total of 231 patients were randomised; 149 patients to the avatrombopag group and 82 patients to the placebo group.
Danish: I studie 1 blev i alt 231 patienter randomiseret: 149 patienter til avatrombopag-gruppen og 82 patienter til placebogruppen.
English: Pale yellow, round biconvex film-coated 7.6 mm tablet debossed with “AVA” on one side and “20” on the other.
Danish: Bleggul, rund, bikonveks, 7,6 mm filmovertrukket tablet med "AVA" præget på den ene side og "20" på den anden.
English: If you forget to take Doptelet
Danish: Hvis du har glemt at tage Doptelet
English: 60 mg (Three 20 mg tablets)
Danish: 60 mg (tre 20 mg tabletter)
English: Contents of the pack and other information What Doptelet contains
Danish: Pakningsstørrelser og yderligere oplysninger Doptelet indeholder:
English: Patients in the low baseline platelet count cohort received 60 mg avatrombopag or matching placebo once daily for 5 days, and patients in the high baseline platelet count cohort received 40 mg avatrombopag or matching placebo once daily for 5 days.
Danish: Patienterne i kohorten med lavt trombocyttal ved baseline fik 60 mg avatrombopag eller tilsvarende placebo en gang dagligt i 5 dage, og patienterne i kohorten med højt trombocyttal ved baseline fik 40 mg avatrombopag eller tilsvarende placebo en gang dagligt i 5 dage.
English: Avatrombopag plasma exposure was comparable in patients with chronic liver disease secondary to viral hepatitis (n = 242), non-alcoholic steatohepatitis (n = 45) and alcoholic liver disease (n = 49) in the pivotal Phase 3 studies, and also comparable to that in healthy subjects (n = 391).
Danish: Avatrombopag-plasmaeksponeringen var sammenlignelig hos patienter med kronisk leversygdom sekundært til viral hepatitis (n = 242), non-alkoholisk steatohepatitis (n = 45) og alkoholisk leversygdom (n = 49) i de pivotale fase 3-studier og var også sammenlignelig med raske forsøgsdeltageres (n = 391).