natgillin/translations-raw huggingface dataset:
Dosering til børn og unge er baseret på legemsvægt (se Tabel 1).
Dosing for children and adolescents is on the basis of body weight (see Table 1).
Ubrugt suspension skal bortskaffes 60 dage efter rekonstitution.
Discard any unused suspension 60 days after constitution.
En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
At the request of the European Medicines Agency, Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• 1 flaske med SPRYCEL oral suspension indeholdende en hvid til gul uigennemsigtig suspension.
• 1 SPRYCEL oral suspension bottle containing a white to yellow opaque suspension.
Synk tabletterne hele.
Swallow the tablets whole.
Raterne for MRD-negativitet ved afslutningen af induktionen og konsolideringen målt vha. flowcytometri var henholdsvis 66,0% og 84,0%.
The MRD negativity rates at the end of induction and consolidation as measured by flow cytometry were 66.0% and 84.0%, respectively.
Om muligt skal der vælges et andet samtidigt lægemiddel uden eller med minimalt potentiale for enzymhæmning.
If possible, an alternative concomitant medication with no or minimal enzyme inhibition potential should be selected.
Brug af SPRYCEL sammen med mad og drikke Du må ikke tage SPRYCEL sammen med grapefrugt eller grapefrugtjuice.
SPRYCEL with food and drink Do not take SPRYCEL with grapefruit or grapefruit juice.
Vær særligt forsigtig når du kører bil eller bruger maskiner, da du kan opleve bivirkninger som for eksempel svimmelhed og sløret syn.
Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.
Mens patienten står op placeres spidsen af sprøjten i munden mellem tungen og siden af munden.
With the patient in an upright position, place the tip of the syringe into the mouth between the side of the mouth and the tongue.
Ved den maksimale dosis på 16 ml SPRYCEL oral suspension svarer dette til 1,7% af den WHO-anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
At the maximum daily dose of 16 mL oral suspension, this is equivalent to 1.7% of the WHO recommended maximum daily dietary intake of 2 g sodium for an adult.
Din læge vil fastsætte den rigtige dosis baseret på alder og vægt.
Your doctor will decide the right dose based on age and weight.
Sørg for at omryste den anden flaske før brug.
Make sure the second bottle is shaken before use.
Hazard ratio (HR) inden for 12 måneder (99,99% CI)
Hazard ratio (HR) within 12 months (99.99% CI)
PK for dasatinib viste dosisproportionalitet med en dosisrelateret stigning i eksponering observeret hos pædiatriske patienter.
Dasatinib PK showed dose proportionality with a dose-related increase in exposure observed in paediatric patients.
Tilsæt 77,0 ml renset vand til flasken på én gang og luk flasken tæt med låget.
Add 77.0 mL of purified water all at once to the bottle and close tightly with closure.
Patienter med let, moderat eller alvorligt nedsat leverfunktion kan få den anbefalede startdosis.
Patients with mild, moderate or severe hepatic impairment may receive the recommended starting dose.
Ud over imatinib, havde 35% af patienterne tidligere modtaget cytotoksisk kemoterapi, 65% havde tidligere modtaget interferon, og 10% havde tidligere modtaget stamcelletransplantation.
In addition to imatinib, 35% of patients had received prior cytotoxic chemotherapy, 65% had received prior interferon, and 10% had received a prior stem cell transplant.
Dette er blisterkort, hvor ugedagene er angivet.
These are blisters showing the days of the week.
Det kan tages med eller uden mad og bør tages konsekvent enten om morgenen eller om aftenen (se pkt.
It can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2).
Hvidt til næsten hvidt pulver.
White to off-white powder.
6.6 Regler for bortskaffelse og anden håndtering De filmovertrukne tabletter består af en kernetablet, omgivet af filmovertræk for at undgå, at sundhedspersonalet udsættes for det aktive stof.
6.6 Special precautions for disposal and other handling The film-coated tablets consist of a core tablet, surrounded by a film-coating to prevent exposure of healthcare professionals to the active substance.
Disse er kumulative rater, der repræsenterer den tidligste opfølgning i den nævnte periode.
These are cumulative rates representing minimum follow up for the timeframe specified.
n/a Varighed af MaHR (%; Kaplan-Meier estimates) 1 år n/a
n/a Duration of MaHR (%; Kaplan-Meier estimates) 1 year n/a
Et bioækvivalensstudie, der evaluerede pulveret til oral suspension i forhold til referencetabletformuleringen hos 77 voksne patienter, viste at eksponeringen for pulveret til oral suspension var 19% lavere end for referencetabletten.
A bioequivalence study evaluating the powder for oral suspension to the reference tablet formulation in 77 adult patients showed that the exposure for the powder for oral suspension was 19% less than that of reference tablets.
Diagnosticeringen bør følge almindeligt gældende retningslinjer.
The diagnostic approach should follow standard practice guidelines.
Tabletterne kan være pakket i pakninger med kalenderblisterkort.
The tablets may come in packs with calendar blisters.
SPRYCEL filmovertrukne tabletter og SPRYCEL pulver til oral suspension er ikke bioækvivalente.
SPRYCEL film-coated tablets and SPRYCEL powder for oral suspension are not bioequivalent.
Patienten bør testes for HBV-infektion før initiering af behandling med SPRYCEL.
Patients should be tested for HBV infection before initiating treatment with SPRYCEL.
Brug den orale sprøjte der medfølger i pakningen.
Use the oral syringe included in the package.
1 flaske med 33 g pulver 1 adapter til flasken 1 oral sprøjte
1 bottle of 33 g powder 1 bottle adapter 1 oral syringe
HDPE-flaske med børnesikret polypropylenlåg.
HDPE bottle with a polypropylene child-resistant closure.
Legemsvægt (kg)a
Body Weight (kg)a
Bivirkninger rapporteret i disse to pædiatriske studier med en hyppighed på 10% hos patienter i et kontinuerligt dosisregime, fremgår af Tabel 7.
Adverse reactions reported in these two paediatric studies at a frequency of 10% in patients on a continuous dosing regimen are shown in Table 7.
Da dasatinib og dets metabolitter har en nyre-clearance < 4%, forventes total-clearance ikke at falde hos patienter med nyreinsufficiens.
Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Det skal du vide, før du begynder at tage SPRYCEL 3.
What you need to know before you take SPRYCEL 3.
Med en minimumsopfølgning på 24 måneder har kun 21 ud af de 240 patienter, som opnåede et MCyR, progredieret, og MCyRs medianvarighed er ikke bestemt.
With a minimum of 24 months follow-up, 21 of the 240 patients who had achieved a MCyR had progressed and the median duration of MCyR had not been reached.
SPRYCEL indeholder svovldioxid (E220) Kan i sjældne tilfælde medføre svære overfølsomhedsreaktioner og vejrtrækningsproblemer.
SPRYCEL contains sulphur dioxide (E220) May rarely cause severe hypersensitivity reactions and bronchospasm.
519 patienter blev randomiseret til en behandlingsgruppe: 259 til SPRYCEL og 260 til imatinib.
A total of 519 patients were randomised to a treatment group: 259 to SPRYCEL and 260 to imatinib.
Forekomst af cytopenier afhang også tydeligt af sygdommens stadie.
However, the occurrence of cytopaenias was also clearly dependent on the stage of the disease.
Dette inkluderer patienter med hypokaliæmi eller hypomagnesiæmi, patienter med kongenit langt QT-syndrom, patienter der tager antiarytmika eller andre lægemidler, som medfører QTforlængelse samt kumulative høje doser af anthracyclin.
These include patients with hypokalaemia or hypomagnesaemia, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicinal products or other medicinal products which lead to QT prolongation, and cumulative high dose anthracycline therapy.
Det var ikke muligt at afgøre, hvorvidt disse mucokutane bivirkninger var direkte relateret til SPRYCEL eller til samtidig behandling med andre lægemidler.
It could not be determined whether these mucocutaneous adverse reactions were directly related to SPRYCEL or to concomitant medicinal product.
En statistisk signifikant større del af patienterne i SPRYCEL gruppen opnåede cCCyR sammenlignet med patienterne i imatinib gruppen inden for de første 12 måneder af behandlingen.
A statistically significantly greater proportion of patients in the SPRYCEL group achieved a cCCyR compared with patients in the imatinib group within the first 12 months of treatment.
Tag ikke SPRYCEL hvis du er allergisk over for dasatinib eller et af de øvrige indholdsstoffer i SPRYCEL (angivet i afsnit 6).
Do not take SPRYCEL if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).
Trin 5: Dispensér flasken med den monterede PIBA, indlægssedlen samt den orale doseringssprøjte i den originale karton til patienten eller omsorgspersonen.
Step 5: Dispense the bottle with inserted PIBA, package leaflet, and oral dosing syringe in the original carton to the patient or caregiver.
SPRYCEL kan tages med eller uden mad.
SPRYCEL can be taken with or without a meal.
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.
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.
Pædiatriske patienter med ALL
Paediatric patients with ALL
• Opbevar den rekonstituerede orale suspension i køleskab (2°C - 8°C).
• Store the constituted oral suspension in a refrigerator (2°C - 8°C).
g Smerter i bevægeapparatet rapporteret under eller efter ophør af behandling.
g Musculoskeletal pain reported during or after discontinuing treatment.
• En lille beholder med vand til at skylle sprøjten efter brug.
• A small container filled with water to use to rinse the syringe.
• Hvis mængden, der er behov for, overstiger 11 ml, skal den deles op i 2 doser, som vist nedenfor:
• If the amount needed is greater than 11 mL, it must be split into 2 doses as shown below:
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.
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.
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.
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.
Hvorvidt fundene fra karcinogenicitetsstudiet med rotter har relevans for mennesker er ukendt.
The relevance of the findings from the rat carcinogenicity study for humans is not known.
Eskalering
Escalation
I et to-årigt karcinogenicitetsstudie fik rotter orale dasatinib doser på 0,3, 1 og 3 mg/kg/dag.
In a two-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day.
Standardkemoterapiregimet var det samme som det, der blev anvendt i AIEOP-BFM ALL 2000-studiet (kemoterapeutisk standardmultistofskemoterapiprotokol).
The backbone chemotherapy regimen was the same as used in the AIEOP-BFM ALL 2000 trial (chemotherapeutic standard multi-agent chemotherapy protocol).
Myelosuppression sås også mindre hyppigt i behandlingsgruppen med 100 mg én gang dagligt (se nedenstående: Afvigelser i laboratorieundersøgelser).
Myelosuppression was also reported less frequently in the 100 mg once daily treatment group (see Laboratory test abnormalities below).
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).
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).
SPRYCEL nedbrydes hovedsageligt af leveren.
SPRYCEL is mainly handled by the liver.
“pure red cell” aplasi
Rare aplasia pure red cell
Dette skyldes, at SPRYCEL kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket kan være dødeligt i nogle tilfælde.
This is because SPRYCEL could cause hepatitis B to become active again, which can be fatal in some cases.
b Komplet cytogenisk respons (CCyR) er baseret på en enkelt cytogenetisk knoglemarvsundersøgelse.
b Complete cytogenetic response (CCyR) is based on a single bone marrow cytogenetic evaluation.
Den anbefalede daglige startdosis af SPRYCEL tabletter til pædiatriske patienter er vist i Tabel 1.
The recommended starting daily dosage of SPRYCEL tablets in paediatric patients is shown in Table 1.
Hvis pleuraeffusion diagnosticeres, skal dasatinib afbrydes, indtil patienten er undersøgt, asymptomatisk eller er vendt tilbage til baseline.
If a pleural effusion is diagnosed, dasatinib should be interrupted until patient is examined, asymptomatic or has returned to baseline.
MCyR (0%-35%) kombinerer både fuldstændigt og delvist respons.
MCyR (0%-35%) combines both complete and partial responses.
• Hvis ikke sprøjten kan fyldes tilstrækkeligt med én flaske, tag da en anden flaske i brug for at fylde sprøjten med den ordinerede dosis.
• If unable to fill with one bottle, use the second bottle to complete the full prescribed dose.
Dosering er baseret på legemsvægt (se Tabel 1).
Dosing is on the basis of body weight (see Table 1).
Når antacida administreredes 2 timer inden indtagelse af enkeltdosis SPRYCEL sås der imidlertid ingen relevante ændringer i koncentration eller eksponeringen af dasatinib.
However, when antacids were administered 2 hours prior to a single dose of SPRYCEL, no relevant changes in dasatinib concentration or exposure were observed.
Hvis du er gravid, eller har mistanke om, at du er gravid, skal du straks informere lægen om dette.
If you are pregnant or think you may be pregnant, tell your doctor immediately.
17 patienter havde 2 separate bivirkninger, 6 havde 3 bivirkninger, 18 havde 4-8 bivirkninger og 5 havde > 8 hændelser med pleuraeffusion.
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.
MCyR opnåedes hos 55% af de imatinib resistente patienter og 82% af de imatinib intolerante patienter.
MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients.
Ikke kendt nefrotisk syndrom Graviditet, puerperium og den perinatale periode
Not known nephrotic syndrome Pregnancy, puerperium and perinatal conditions
Hos rotter var minimale til milde fald i erythrocytparametre ledsaget af knoglemarvsforandringer; tilsvarende forandringer sås hos aber med lavere incidens.
In rats, minimal to mild decreases in erythrocyte parameters were accompanied by bone marrow changes; similar changes occurred in monkeys at a lower incidence.
LÆGEMIDDELFORM Filmovertrukne tabletter (tablet).
PHARMACEUTICAL FORM Film-coated tablet (tablet).
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.
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.
Der er derfor risiko for interaktion med andre samtidigt administrerede lægemidler, der primært metaboliseres af eller modulerer aktiviteten af CYP3A4 (se pkt.
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).
Du må ikke tage medicin, som neutraliserer mavesyre (syrehæmmende midler som aluminiumhydroxid eller magnesiumhydroxid) i 2 timer inden eller 2 timer efter SPRYCEL.
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.
Der bør udvises forsigtighed, hvis patienten har behov for lægemidler, der hæmmer trombocytfunktionen eller antikoagulantia.
Caution should be exercised if patients are required to take medicinal products that inhibit platelet function or anticoagulants.
Ikke-kliniske data viser, at dasatinibs opløselighed er pH-afhængig.
Non-clinical data demonstrate that the solubility of dasatinib is pH-dependent.
Din læge vil fastsætte den rigtige dosis baseret på din vægt.
Your doctor will decide the right dose based on your weight.
Effekten blev også vurderet hos patienter, som var intolerante over for imatinib.
Efficacy was also assessed in patients who were intolerant to imatinib.
Transfusion af trombocytter og røde blodlegemer anvendtes i det omfang, det var relevant.
Platelet transfusion and red cell transfusion were used as appropriate.
Se indlægsseddel for yderligere oplysninger.
See the package leaflet for further information.
Trin 3: Fjern lukningen, indsæt adapteren (PIBA) i flaskens hals og luk flasken tæt med den børnesikrede lukning.
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.
38% af patienterne havde baseline-mutationer, der vides at medføre imatinib resistens.
Thirty-eight percent of patients had baseline mutations known to confer imatinib resistance.
CML i kronisk fase - nyligt diagnosticeret
Chronic phase CML - Newly diagnosed
Patienter, der udviklede grad 3 eller 4 hypokalcæmi, kom sig ofte med oralt calciumtilskud.
Patients developing grade 3 or 4 hypocalcaemia often had recovery with oral calcium supplementation.
Kan i sjældne tilfælde medføre svære overfølsomhedsreaktioner og bronkospasme.
May rarely cause severe hypersensitivity reactions and bronchospasm.
In vitro er dasatinib aktivt i leukæmiske cellelinjer, der repræsenterer varianter af imatinibfølsom ogresistent sygdom.
In vitro, dasatinib is active in leukaemic cell lines representing variants of imatinib-sensitive and resistant disease.
Dasatinib havde fototoksisk potentiale i et in vitro neutral red uptake fototoksicitets-assay i musefibroblaster.
Dasatinib had phototoxic potential in an in vitro neutral red uptake phototoxicity assay in mouse fibroblasts.
Det anbefales ikke at bruge SPRYCEL under graviditet.
Use of SPRYCEL is not recommended during pregnancy.
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)
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)
Efter opklaring af den første episode bør genintroduktion af dasatinib ved det samme dosisniveau overvejes.
Following resolution of the first episode, reintroduction of dasatinib at the same dose level should be considered.
Færre end 10% af patienterne med pleuraeffusion havde svær (grad 3 eller 4) dasatinib relateret pleuraeffusion.
Less than 10% of patients with pleural effusion had severe (grade 3 or 4) dasatinib-related pleural effusions.
Plasmakoncentration og målt in vitro aktivitet viser, at dasatinibmetabolitter sandsynligvis ikke spiller en større rolle i produktets observerede farmakologi.
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.
Benzoesyre og benzoater
Benzoic acid and benzoates
Farmakodynamik
Pharmacodynamics
Både mænd og kvinder, der tager SPRYCEL tilrådes at bruge effektiv beskyttelse mod graviditet under behandling.
Both men and women taking SPRYCEL will be advised to use effective contraception during treatment.
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.
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.
I de pædiatriske CML-studier var frekvenserne af laboratorieabnormiteter konsistente med den kendte profil for laboratorieparametre hos voksne.
In the paediatric CML studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults.
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.
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.
Det primære endepunkt var cCCyR (confirmed complete cytogenetic response) inden for 12 måneder.
The primary endpoint was the rate of confirmed complete cytogenetic response (cCCyR) within 12 months.
MR4.5-rater over tid er vist grafisk i Figur 3.
MR4.5 rates over time are displayed graphically in Figure 3.
Ydre karton: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
Outer Carton: 2D barcode carrying the unique identifier included.
Før rekonstitution rystes flasken grundigt før hver brug.
After constitution, shake bottle well before each use.
Hvis episoden ikke bedres inden for ca. en uge, bør behandling med diuretika eller kortikosteroider eller begge dele overvejes (se pkt.
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).
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE06
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE06
GRUPPE
GROUP
Visse andre typer medicin kan påvirke virkningen af SPRYCEL, hvis det tages samtidigt med SPRYCEL.
Certain medicines may interfere with the effect of SPRYCEL when taken together.
Hvis der er et forhøjet niveau af anti-ADAMTS13-antistof kombineret med lav ADAMTS13-aktivitet, skal behandling med SPRYCEL ikke genoptages.
If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with SPRYCEL should not be resumed.
Febril neutropeni Kvalme
Febrile neutropaenia Nausea
CML i accelereret fase
Accelerated phase CML
Efter mindst 60 måneders opfølgning var den kumulative rate for neutropeni, trombocytopeni og anæmi henholdsvis 29%, 22% og 13%.
After a minimum of 60 months follow-up, the cumulative rates of neutropaenia, thrombocytopaenia, and anaemia were 29%, 22% and 13%, respectively.
Der var 33 nydiagnosticerede patienter med CML-CP, der fik SPRYCEL pulver til oral suspension ved en dosis på 72 mg/m2.
There were 33 newly diagnosed paediatric patients with CML-CP who received SPRYCEL powder for oral suspension at a dose of 72 mg/m2.