FrancophonIA/ELRC3.0 huggingface dataset:
English: Step 5: Dispense the bottle with inserted PIBA, package leaflet, and oral dosing syringe in the original carton to the patient or caregiver.
Danish: Trin 5: Dispensér flasken med den monterede PIBA, indlægssedlen samt den orale doseringssprøjte i den originale karton til patienten eller omsorgspersonen.
English: SPRYCEL can be taken with or without a meal.
Danish: SPRYCEL kan tages med eller uden mad.
English: In patients, dasatinib has a large apparent volume of distribution (2,505 L), coefficient of variation (CV% 93%), suggesting that the medicinal product is extensively distributed in the extravascular space.
Danish: Dasatinib har hos patienter et stort tilsyneladende fordelingsvolumen (2.505 l), variationskoefficient (CV% 93%), hvilket tyder på, at produktet i omfattende grad fordeles i det ekstravaskulære rum.
English: Paediatric patients with ALL
Danish: Pædiatriske patienter med ALL
English: • Store the constituted oral suspension in a refrigerator (2°C - 8°C).
Danish: • Opbevar den rekonstituerede orale suspension i køleskab (2°C - 8°C).
English: g Musculoskeletal pain reported during or after discontinuing treatment.
Danish: g Smerter i bevægeapparatet rapporteret under eller efter ophør af behandling.
English: • A small container filled with water to use to rinse the syringe.
Danish: • En lille beholder med vand til at skylle sprøjten efter brug.
English: • If the amount needed is greater than 11 mL, it must be split into 2 doses as shown below:
Danish: • Hvis mængden, der er behov for, overstiger 11 ml, skal den deles op i 2 doser, som vist nedenfor:
English: Women of childbearing potential/contraception in males and females Both sexually active men and women of childbearing potential should use effective methods of contraception during treatment.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Både seksuelt aktive mænd og kvinder i den fødedygtige alder skal anvende effektive antikonceptionsmetoder under behandlingen.
English: The geometric means of dosenormalized dasatinib Cmax, AUC (0-T), and AUC (INF) appeared to be similar between children and adolescents at different dose levels.
Danish: De geometriske middelværdier for dosisnormaliseret dasatinib Cmax, AUC (0-T) og AUC (INF) så ud til at være sammenlignelige mellem børn og unge ved forskellige dosisniveauer.
English: The relevance of the findings from the rat carcinogenicity study for humans is not known.
Danish: Hvorvidt fundene fra karcinogenicitetsstudiet med rotter har relevans for mennesker er ukendt.
English: Escalation
Danish: Eskalering
English: In a two-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day.
Danish: I et to-årigt karcinogenicitetsstudie fik rotter orale dasatinib doser på 0,3, 1 og 3 mg/kg/dag.
English: The backbone chemotherapy regimen was the same as used in the AIEOP-BFM ALL 2000 trial (chemotherapeutic standard multi-agent chemotherapy protocol).
Danish: Standardkemoterapiregimet var det samme som det, der blev anvendt i AIEOP-BFM ALL 2000-studiet (kemoterapeutisk standardmultistofskemoterapiprotokol).
English: Myelosuppression was also reported less frequently in the 100 mg once daily treatment group (see Laboratory test abnormalities below).
Danish: Myelosuppression sås også mindre hyppigt i behandlingsgruppen med 100 mg én gang dagligt (se nedenstående: Afvigelser i laboratorieundersøgelser).
English: Based on the patient population PK analysis, variability in dasatinib exposure was estimated to be mainly due to inter-occasion variability in bioavailability (44% CV) and, to a lesser extent, due to inter-individual variability in bioavailability and inter-individual variability in clearance (30% and 32% CV, respectively).
Danish: På baggrund af PK-analysen af patientpopulationen blev variabiliteten i dasatinib-eksponering estimeret til hovedsageligt at skyldes variation i biotilgængelighed mellem prøvetagningerne (44% CV) og i mindre grad interindividuel variabilitet i biotilgængelighed og interindividuel variabilitet i clearance (henholdsvis 30 % og 32% CV).
English: SPRYCEL is mainly handled by the liver.
Danish: SPRYCEL nedbrydes hovedsageligt af leveren.
English: Rare aplasia pure red cell
Danish: “pure red cell” aplasi
English: This is because SPRYCEL could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at SPRYCEL kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket kan være dødeligt i nogle tilfælde.
English: b Complete cytogenetic response (CCyR) is based on a single bone marrow cytogenetic evaluation.
Danish: b Komplet cytogenisk respons (CCyR) er baseret på en enkelt cytogenetisk knoglemarvsundersøgelse.
English: The recommended starting daily dosage of SPRYCEL tablets in paediatric patients is shown in Table 1.
Danish: Den anbefalede daglige startdosis af SPRYCEL tabletter til pædiatriske patienter er vist i Tabel 1.
English: If a pleural effusion is diagnosed, dasatinib should be interrupted until patient is examined, asymptomatic or has returned to baseline.
Danish: Hvis pleuraeffusion diagnosticeres, skal dasatinib afbrydes, indtil patienten er undersøgt, asymptomatisk eller er vendt tilbage til baseline.
English: MCyR (0%-35%) combines both complete and partial responses.
Danish: MCyR (0%-35%) kombinerer både fuldstændigt og delvist respons.
English: • If unable to fill with one bottle, use the second bottle to complete the full prescribed dose.
Danish: • Hvis ikke sprøjten kan fyldes tilstrækkeligt med én flaske, tag da en anden flaske i brug for at fylde sprøjten med den ordinerede dosis.
English: Dosing is on the basis of body weight (see Table 1).
Danish: Dosering er baseret på legemsvægt (se Tabel 1).
English: However, when antacids were administered 2 hours prior to a single dose of SPRYCEL, no relevant changes in dasatinib concentration or exposure were observed.
Danish: Når antacida administreredes 2 timer inden indtagelse af enkeltdosis SPRYCEL sås der imidlertid ingen relevante ændringer i koncentration eller eksponeringen af dasatinib.
English: If you are pregnant or think you may be pregnant, tell your doctor immediately.
Danish: Hvis du er gravid, eller har mistanke om, at du er gravid, skal du straks informere lægen om dette.
English: Seventeen patients had 2 separate adverse reactions, 6 had 3 adverse reactions, 18 had 4 to 8 adverse reactions and 5 had > 8 episodes of pleural effusions.
Danish: 17 patienter havde 2 separate bivirkninger, 6 havde 3 bivirkninger, 18 havde 4-8 bivirkninger og 5 havde > 8 hændelser med pleuraeffusion.
English: MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients.
Danish: MCyR opnåedes hos 55% af de imatinib resistente patienter og 82% af de imatinib intolerante patienter.
English: Not known nephrotic syndrome Pregnancy, puerperium and perinatal conditions
Danish: Ikke kendt nefrotisk syndrom Graviditet, puerperium og den perinatale periode
English: In rats, minimal to mild decreases in erythrocyte parameters were accompanied by bone marrow changes; similar changes occurred in monkeys at a lower incidence.
Danish: Hos rotter var minimale til milde fald i erythrocytparametre ledsaget af knoglemarvsforandringer; tilsvarende forandringer sås hos aber med lavere incidens.
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Danish: LÆGEMIDDELFORM Filmovertrukne tabletter (tablet).
English: Disease progression was defined as increasing white blood cells despite appropriate therapeutic management, loss of CHR, partial CyR or CCyR, progression to accelerated phase or blast phase, or death.
Danish: Sygdomsprogression blev defineret som øget antal hvide blodlegemer til trods for hensigtsmæssig terapeutisk behandling, tab af CHR, partiel CyR eller CCyR, progression til accelereret fase eller blastfase eller død.
English: Therefore, there is a potential for interaction with other concomitantly administered medicinal products that are metabolised primarily by or modulate the activity of CYP3A4 (see section 4.5).
Danish: Der er derfor risiko for interaktion med andre samtidigt administrerede lægemidler, der primært metaboliseres af eller modulerer aktiviteten af CYP3A4 (se pkt.
English: Do not take medicines that neutralise stomach acids (antacids such as aluminium hydroxide or magnesium hydroxide) in the 2 hours before or 2 hours after taking SPRYCEL.
Danish: Du må ikke tage medicin, som neutraliserer mavesyre (syrehæmmende midler som aluminiumhydroxid eller magnesiumhydroxid) i 2 timer inden eller 2 timer efter SPRYCEL.
English: Caution should be exercised if patients are required to take medicinal products that inhibit platelet function or anticoagulants.
Danish: Der bør udvises forsigtighed, hvis patienten har behov for lægemidler, der hæmmer trombocytfunktionen eller antikoagulantia.
English: Non-clinical data demonstrate that the solubility of dasatinib is pH-dependent.
Danish: Ikke-kliniske data viser, at dasatinibs opløselighed er pH-afhængig.
English: Your doctor will decide the right dose based on your weight.
Danish: Din læge vil fastsætte den rigtige dosis baseret på din vægt.
English: Efficacy was also assessed in patients who were intolerant to imatinib.
Danish: Effekten blev også vurderet hos patienter, som var intolerante over for imatinib.
English: Platelet transfusion and red cell transfusion were used as appropriate.
Danish: Transfusion af trombocytter og røde blodlegemer anvendtes i det omfang, det var relevant.
English: See the package leaflet for further information.
Danish: Se indlægsseddel for yderligere oplysninger.
English: Step 3: Remove the closure, insert the press-in bottle adapter (PIBA) into the bottle neck, and close the bottle tightly with the child-resistant closure.
Danish: Trin 3: Fjern lukningen, indsæt adapteren (PIBA) i flaskens hals og luk flasken tæt med den børnesikrede lukning.
English: Thirty-eight percent of patients had baseline mutations known to confer imatinib resistance.
Danish: 38% af patienterne havde baseline-mutationer, der vides at medføre imatinib resistens.
English: Chronic phase CML - Newly diagnosed
Danish: CML i kronisk fase - nyligt diagnosticeret
English: Patients developing grade 3 or 4 hypocalcaemia often had recovery with oral calcium supplementation.
Danish: Patienter, der udviklede grad 3 eller 4 hypokalcæmi, kom sig ofte med oralt calciumtilskud.
English: May rarely cause severe hypersensitivity reactions and bronchospasm.
Danish: Kan i sjældne tilfælde medføre svære overfølsomhedsreaktioner og bronkospasme.
English: In vitro, dasatinib is active in leukaemic cell lines representing variants of imatinib-sensitive and resistant disease.
Danish: In vitro er dasatinib aktivt i leukæmiske cellelinjer, der repræsenterer varianter af imatinibfølsom ogresistent sygdom.
English: Dasatinib had phototoxic potential in an in vitro neutral red uptake phototoxicity assay in mouse fibroblasts.
Danish: Dasatinib havde fototoksisk potentiale i et in vitro neutral red uptake fototoksicitets-assay i musefibroblaster.
English: Use of SPRYCEL is not recommended during pregnancy.
Danish: Det anbefales ikke at bruge SPRYCEL under graviditet.
English: Bleeding in the stomach or bowels that can cause death Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection)
Danish: Blødning i maven eller tarmene, som kan forårsage død Genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B (leverbetændelse type B)
English: Following resolution of the first episode, reintroduction of dasatinib at the same dose level should be considered.
Danish: Efter opklaring af den første episode bør genintroduktion af dasatinib ved det samme dosisniveau overvejes.
English: Less than 10% of patients with pleural effusion had severe (grade 3 or 4) dasatinib-related pleural effusions.
Danish: Færre end 10% af patienterne med pleuraeffusion havde svær (grad 3 eller 4) dasatinib relateret pleuraeffusion.
English: Plasma concentration and measured in vitro activity indicate that metabolites of dasatinib are unlikely to play a major role in the observed pharmacology of the product.
Danish: Plasmakoncentration og målt in vitro aktivitet viser, at dasatinibmetabolitter sandsynligvis ikke spiller en større rolle i produktets observerede farmakologi.
English: Benzoic acid and benzoates
Danish: Benzoesyre og benzoater
English: Pharmacodynamics
Danish: Farmakodynamik
English: Both men and women taking SPRYCEL will be advised to use effective contraception during treatment.
Danish: Både mænd og kvinder, der tager SPRYCEL tilrådes at bruge effektiv beskyttelse mod graviditet under behandling.
English: Based on human experience, dasatinib is suspected to cause congenital malformations including neural tube defects, and harmful pharmacological effects on the foetus when administered during pregnancy.
Danish: Baseret på humane data er dasatinib under mistanke for at medføre medfødte misdannelser, herunder neuralrørsdefekter og skadelige farmakologiske virkninger på fostret, når det anvendes under graviditet.
English: In the paediatric CML studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults.
Danish: I de pædiatriske CML-studier var frekvenserne af laboratorieabnormiteter konsistente med den kendte profil for laboratorieparametre hos voksne.
English: Among patients who had received imatinib 400 mg prior to study entry, MCyR was achieved in 61% of patients in the dasatinib arm and 50% in the imatinib arm.
Danish: Blandt patienter som fik imatinib 400 mg inden inklusion i studiet opnåedes MCyR hos 61% af patienterne i dasatinib armen og 50% i imatinib armen.
English: The primary endpoint was the rate of confirmed complete cytogenetic response (cCCyR) within 12 months.
Danish: Det primære endepunkt var cCCyR (confirmed complete cytogenetic response) inden for 12 måneder.
English: MR4.5 rates over time are displayed graphically in Figure 3.
Danish: MR4.5-rater over tid er vist grafisk i Figur 3.
English: Outer Carton: 2D barcode carrying the unique identifier included.
Danish: Ydre karton: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: After constitution, shake bottle well before each use.
Danish: Før rekonstitution rystes flasken grundigt før hver brug.
English: If the episode does not improve within approximately one week, a course of diuretics or corticosteroids or both concurrently should be considered (see sections 4.4 and 4.8).
Danish: Hvis episoden ikke bedres inden for ca. en uge, bør behandling med diuretika eller kortikosteroider eller begge dele overvejes (se pkt.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE06
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE06
English: GROUP
Danish: GRUPPE
English: Certain medicines may interfere with the effect of SPRYCEL when taken together.
Danish: Visse andre typer medicin kan påvirke virkningen af SPRYCEL, hvis det tages samtidigt med SPRYCEL.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with SPRYCEL should not be resumed.
Danish: Hvis der er et forhøjet niveau af anti-ADAMTS13-antistof kombineret med lav ADAMTS13-aktivitet, skal behandling med SPRYCEL ikke genoptages.
English: Febrile neutropaenia Nausea
Danish: Febril neutropeni Kvalme
English: Accelerated phase CML
Danish: CML i accelereret fase
English: After a minimum of 60 months follow-up, the cumulative rates of neutropaenia, thrombocytopaenia, and anaemia were 29%, 22% and 13%, respectively.
Danish: Efter mindst 60 måneders opfølgning var den kumulative rate for neutropeni, trombocytopeni og anæmi henholdsvis 29%, 22% og 13%.
English: There were 33 newly diagnosed paediatric patients with CML-CP who received SPRYCEL powder for oral suspension at a dose of 72 mg/m2.
Danish: Der var 33 nydiagnosticerede patienter med CML-CP, der fik SPRYCEL pulver til oral suspension ved en dosis på 72 mg/m2.
English: If neutropaenia and/or thrombocytopaenia persist and the next block of treatment is delayed another 7 days, a bone marrow assessment should be performed to assess cellularity and percentage of blasts.
Danish: Hvis neutropeni og/eller trombocytopeni fortsætter, og den næste behandlingsserie udsættes yderligere 7 dage, skal der udføres en knoglemarvsundersøgelse for at vurdere cellularitet og procentdel af blaster.
English: After constitution, one bottle contains 99 mL of oral suspension.
Danish: Efter rekonstitution indeholder én flaske 99 ml oral suspension.
English: In these patients grade 3 or 4 pulmonary oedema and pulmonary hypertension were each reported in 1% of patients.
Danish: Hos disse patienter blev grad 3 eller 4 lungeødem og pulmonal hypertension hver især indberettet hos 1% af patienterne.
English: Dasatinib and its metabolites are minimally excreted via the kidney.
Danish: Dasatinib og dets metabolitter udskilles minimalt via nyrerne.
English: Results are shown in Table 15.
Danish: Resultaterne er angivet i Tabel 15.
English: In a supportive study, of 55 paediatric patients, 35 received SPRYCEL in combination with chemotherapy on a discontinuous dosing regimen (two weeks on treatment followed by one to two weeks off) and 20 received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Danish: I et understøttende studie fik 35 ud af 55 pædiatriske patienter SPRYCEL i kombination med kemoterapi i et diskontinuerligt dosisregime (to uger i behandling efterfulgt af en til to uger uden behandling), og 20 fik SPRYCEL i kombination med kemoterapi i et kontinuerligt dosisregime.
English: In patients in whom rifampicin or other CYP3A4 inducers are indicated, alternative medicinal products with less enzyme induction potential should be used.
Danish: Til patienter med behov for rifampicin eller andre CYP3A4-induktorer bør der anvendes alternative lægemidler med mindre enzyminduktionspotentiale.
English: Grade 3 or 4 pleural effusion may require thoracocentesis and oxygen therapy.
Danish: Pleuraeffusion grad 3 eller 4 kan kræve thoracocentese og iltbehandling.
English: Approximately 5% of the SPRYCEL-treated patients who had normal baseline levels experienced grade 3 or 4 transient hypocalcaemia at some time during the course of the study.
Danish: Ca. 5% af de SPRYCEL behandlede patienter, som havde normale baseline-niveauer, oplevede grad 3 eller 4 forbigående hypokalcæmi på et tidspunkt under forløbet.
English: Paediatric population (Ph+ CML-CP and Ph+ ALL)
Danish: Pædiatrisk population (Ph+ CML-CP og Ph+ ALL)
English: Slowly withdraw the amount of SPRYCEL oral suspension prescribed by pulling the syringe plunger until it reaches the marking of the dose prescribed.
Danish: Træk langsomt den ordinerede mængde SPRYCEL oral suspension ud af flasken ved at trække sprøjtens stempel nedad, indtil markeringen, der svarer til den ordinerede dosis, nås.
English: There is no experience with SPRYCEL treatment in children under 1 year of age.
Danish: Der er ingen erfaring med SPRYCEL behandling til børn under 1 år.
English: The highest dose resulted in a plasma exposure (AUC) level generally equivalent to the human exposure at the recommended range of starting doses from 100 mg to 140 mg daily.
Danish: Den højeste dosis medførte plasmaniveauer (AUC), der generelt svarer til niveauet hos mennesker ved den anbefalede startdosis på mellem 100 mg og 140 mg dagligt.
English: Based on the findings from a single-dose pharmacokinetic study, patients with mild, moderate or severe hepatic impairment may receive the recommended starting dose (see section 5.2).
Danish: Baseret på resultaterne fra et enkeltdosis farmakokinetisk studie, kan patienter med let, moderat eller alvorlig leverinsufficiens få den anbefalede startdosis (se pkt.
English: Unchanged dasatinib accounted for 0.1% and 19% of the dose in urine and faeces, respectively, with the remainder of the dose as metabolites.
Danish: Uomdannet dasatinib stod for henholdsvis 0,1% og 19% af dosis i urin og fæces, mens resten af dosis var metabolitter.
English: Therefore, caution should be recommended when driving a car or operating machines.
Danish: Det anbefales derfor, at patienten er forsigtig, når der føres motorkøretøj eller betjenes maskiner.
English: The rate of major molecular response at 24 months was 45% (35% for imatinib-resistant patients and 74% for imatinib-intolerant patients).
Danish: Hyppigheden af major molekylært respons ved 24 måneder var 45% (35% for imatinib resistente patienter og 74% for imatinib intolerante patienter).
English: Dasatinib was clastogenic in vitro to dividing Chinese Hamster Ovary (CHO) cells.
Danish: Dasatinib var clastogent in vitro med deling af CHO-celler (Chinese Hamster Ovary celler).
English: Constituted oral suspension mixed with milk, yogurt, apple juice, or applesauce may be stored at or below 25°C for up to 1 hour.
Danish: Rekonstitueret oral suspension blandet med mælk, yoghurt, æblejuice eller æblemos kan opbevares ved 25°C eller derunder i op til 1 time.
English: Complete haematologic response or MCyR was achieved in patients harbouring a variety of BCR-ABL mutations associated with imatinib resistance except T315I.
Danish: Der opnåedes fuldstændigt hæmatologisk respons eller MCyR hos patienter med en række BCR-ABL-mutationer forbundet med imatinib resistens bortset fra T315I.
English: The median time from diagnosis to randomisation was 64 months in the dasatinib group and 52 months in the imatinib group.
Danish: Mediantid fra diagnose til randomisering var 64 måneder i dasatinib gruppen og 52 måneder i imatinib gruppen.
English: Responses were durable across all phases of CML and Ph+ ALL.
Danish: Respons var varige i alle faser af CML og Ph+ ALL.
English: These effects occurred at doses that did not produce maternal toxicity, indicating that dasatinib is a selective reproductive toxicant from implantation through the completion of organogenesis.
Danish: Disse virkninger forekom ved doser, der ikke gav maternel toksicitet, hvilket tyder på, at dasatinib er et selektivt reproduktionstoksin fra implantationstidspunktet til organogenesen er afsluttet.
English: Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
Danish: Dasatinib var ikke mutagent i in vitro bakterielle celle-assay (Ames test) og var ikke genotoksisk i et in vivo mikronukleus-studie med rotter.
English: Once constituted, the bottle contains 99 mL of oral suspension, of which 90 mL is intended for dosing and administration.
Danish: Efter rekonstitution indeholder flasken 99 ml oral suspension, heraf er 90 ml tiltænkt dosering og administration.
English: Dasatinib was studied in a randomised clinical study of 519 patients with newly diagnosed CML in chronic phase which included patients with prior cardiac disease.
Danish: Dasatinib er blevet undersøgt i et randomiseret klinisk studie med 519 patienter med nyligt diagnosticeret CML i kronisk fase, som inkluderede patienter med tidligere hjertesygdom.
English: Dasatinib exposure variability is higher under fasted conditions (47% CV) compared to light-fat meal (39% CV) and high-fat meal (32% CV) conditions.
Danish: Variabiliteten i dasatinibeksponering er højere i fastende tilstand (47% CV) sammenlignet med et fedtfattigt måltid (39% CV) og et måltid med højt fedtindhold (32% CV).
English: Nine (12%) patients underwent therapeutic thoracentesis.
Danish: Ni patienter (12%) gennemgik terapeutisk torakocentese.
English: Accelerated (n= 174)
Danish: Accelereret (n= 174)
English: For storage conditions after constitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4.
Danish: Dasatinib er et substrat og en hæmmer af cytochrom P450 (CYP)3A4.
English: Dasatinib is extensively metabolised in humans with multiple enzymes involved in the generation of the metabolites.
Danish: Dasatinib metaboliseres i omfattende grad hos mennesker, og mange enzymer er involverede i metaboliseringen.
English: Imatinib-resistant patients n=124
Danish: Imatinib resistente patienter n=124