natgillin/translations-raw huggingface dataset:
h Frekvensen er rapporteret som almindelig i pædiatriske studier.
h Frequency reported as common in paediatric studies.
Pleuraeffusion nedsatte ikke patienternes evne til at opnå respons.
Pleural effusion did not impair the ability of patients to obtain a response.
Patienter med ukontrolleret eller betydelig kardiovaskulær sygdom inkluderedes ikke i kliniske studier.
Patients with uncontrolled or significant cardiovascular disease were not included in the clinical studies.
Der er begrænset erfaring med brug af SPRYCEL i denne aldersgruppe.
There is limited experience with the use of SPRYCEL in this age group.
Tag SPRYCEL dagligt, indtil lægen giver dig besked på at stoppe.
Take SPRYCEL daily until your doctor tells you to stop.
SPRYCEL oral suspension skal tages 1 gang dagligt.
SPRYCEL oral suspension is taken once daily.
Alle patienter n=167
All patients n=167
Dette er fordi store mængder benzylalkohol kan ophobe sig i kroppen og kan forårsage bivirkninger (kaldet "metabolisk acidose").
This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Kalenderpakning: Mandag
calendar pack: Monday Tuesday Wednesday Thursday Friday
Du vil også jævnligt få taget blodprøver, mens du tager SPRYCEL.
You will also have blood tests regularly while you are taking SPRYCEL.
• Må ikke vaskes i opvaskemaskine.
• Do not wash in a dishwasher.
SPRYCEL skal tages på samme tid hver dag.
SPRYCEL should be taken at the same time every day.
Alle patienter var ekstensivt forbehandlede.
All patients were extensively pretreated.
Bemærk, at markeringerne på sprøjten angiver ml.
Note that the markings on the syringe are in mL.
Lægen vil regelmæssigt kontrollere din tilstand for at sikre, at SPRYCEL har den ønskede effekt.
Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect.
CI = konfidensinterval
CI = confidence interval
Tryk langsom stemplet ned indtil hele dosen er blevet givet.
Slowly push the plunger down until all of the dose has been given.
Progressionsfri overlevelseb
Progression-free survivalb
Til oral brug efter rekonstitution.
For oral use after constitution.
Der var ingen signifikant forskel på dasatinibs PK mellem børn og unge.
There was no significant difference of dasatinib PK between children and adolescents.
Almindelig kontusion a Inkluderer nedsat appetit, tidlig mæthedsfornemmelse, øget appetit.
Common contusion a Includes decreased appetite, early satiety, increased appetite.
I disse tilfælde blev PAH rapporteret efter initiering af dasatinib behandling, herunder efter mere end et års behandling.
In these cases, PAH was reported after initiation of dasatinib therapy, including after more than one year of treatment.
Dette bør tages med i overvejelserne for patienter med diabetes mellitus.
This should be taken into account in patients with diabetes mellitus.
Trin 4: Skriv udløbsdatoen for den rekonstituerede orale suspension på flaskens etiket (udløbsdatoen for den orale suspension er 60 dage fra datoen for rekonstitution).
Step 4: Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 60 days from the date of constitution).
• Sæt lukningen tilbage på flasken og luk tæt.
• Put closure back on the bottle and close tightly.
En ændring i dosis kan forekomme når der skiftes mellem formuleringer (dvs. tabletter og pulver til oral suspension), så du bør ikke skifte fra den ene til den anden.
A change in dose may occur when switching between formulations (i.e., tablets and powder for oral suspension), so you should not switch from one to the other.
Den observerede effekt af fødeindtag repræsenterer ikke klinisk relevante ændringer i eksponeringen.
The observed food effects do not represent clinically relevant changes in exposure.
Patienter, der fortsætter behandlingen, bør monitoreres regelmæssigt.
Patients continuing treatment should be monitored periodically.
140 mg 1 gang dagligt n = 304
140 mg once daily n = 304
mindst 45
at least 45
Almindelig tinnitus
Common tinnitus
Det primære endepunkt var MCyR ved 12 uger.
The primary endpoint was MCyR at 12 weeks.
• Gennemgå den totale ordinerede dosis og fastlæg antal milliliter (ml), du skal bruge.
• Review total prescribed dose and determine number of milliliters (mL) you will need.
% med MMR
% with MMR
Tabel 16: Sådan deles en dosis af oral suspension, som er større end 11 ml
Table 16: How to split a dose of oral suspension that is greater than 11 mL
Hvis der ikke findes nogen forklaring eller hvis der ikke ses nogen bedring ved dosisreduktion eller -afbrydelse, bør diagnosen PAH overvejes.
If no explanation is found, or if there is no improvement with dose reduction or interruption, the diagnosis of PAH should be considered.
Du kan ikke være sikker på du får den korrekte dosis, hvis du knuser, deler, tygger eller opløser tabletterne.
You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets.
Hyppigheden defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from available post-marketing data).
MÅNEDER
MONTHS
• Hold fast i stemplet for at undgå det bevæger sig.
• Hold plunger to prevent it from moving.
For detaljer vedrørende forberedelse og administration af dette lægemiddel og instruktioner for brugen, se pkt.
For details on preparation and administration of this medicinal product and instructions for use, see section 6.6.
4.2 for den anbefalede startdosis.
See section 4.2 for the recommended starting dose.
QTintervallet korrigeredes for hjertefrekvens ved Fridericias metode.
QT interval was corrected for heart rate by Fridericia's method.
Den orale suspension er stabil i 60 dage.
After constitution The oral suspension is stable for 60 days.
Patienter under 3 år skal monitoreres for respiratoriske symptomer.
Monitor patients less than 3 years of age for respiratory symptoms.
Lægen vil undersøge dig for nogle af disse bivirkninger under behandlingen.
Your doctor will check for some of these effects during your treatment.
Dette blev sædvanligvis håndteret med dosisreduktion eller afbrydelse.
It was usually managed with dose reduction or interruption.
24 måneder 36 måneder 48 måneder 60 måneder p=0,0021
24 months 36 months 48 months 60 months p=0.0021
Du bør stoppe med at amme, mens du tager SPRYCEL.
You should stop breast-feeding while you are taking SPRYCEL.
Vask sprøjten udvendigt og indvendigt med vand og lad den lufttørre efter hver brug, så den er klar til brug den næste dag.
Wash the outside and the inside of the syringe with water and allow to air dry after each use to reuse for the next day.
Hvis du har glemt at tage SPRYCEL
If you forget to take SPRYCEL
Hvis SPRYCEL anvendes under graviditet, skal patienten informeres om den potentielle risiko for fostret.
If SPRYCEL is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Se ”Instruktioner for administration til patienten” sidst i indlægssedlen for, hvordan en dosis SPRYCEL oral suspension skal gives.
See the "Instructions for administration to the patient" at the end of the package leaflet for how to give a dose of SPRYCEL oral suspension.
Hos patienter, der får en efterfølgende stamcelletransplantation, kan SPRYCEL administreres i yderligere et år efter transplantationen.
In patients that receive a subsequent stem cell transplantation, SPRYCEL can be administered for an additional year post-transplantation.
Figur 1: Kaplan-Meier estimat over tid til major molekylært respons (MMR)
Figure 1: Kaplan-Meier estimate of time to major molecular response (MMR)
ANC: absolut neutrofiltal *lavere tabletdosis ikke tilgængelig
ANC: absolute neutrophil count *lower tablet dose not available
Sådan skal du tage SPRYCEL 4.
How to take SPRYCEL 4.
• Hvis en anden dosis er nødvendig for at give hele den ordinerede dosis, gentag da trin 3 til 10.
• If a second dose is needed to complete the total prescribed dose, repeat steps 3 through 10.
SPRYCEL skal administreres oralt.
SPRYCEL must be administered orally.
Afhængigt af hvordan behandlingen virker på dig, kan lægen foreslå en højere eller lavere dosis eller foreslå, at behandlingen afbrydes kortvarigt.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose, or even stopping treatment briefly.
Den gennemsnitlige tilsyneladende orale clearance er 363,8 l/t (CV% 81,3%).
The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%).
Dasatinib bør administreres med forsigtighed til patienter som har, eller kan udvikle, forlængelse af QTc.
Dasatinib should be administered with caution to patients who have or may develop prolongation of QTc.
Der er i alt evalueret 2.712 patienter i kliniske studier; af disse var 23% ≥ 65 år og 5% ≥ 75 år.
A total of 2,712 patients were evaluated in clinical studies; of these 23% were ≥ 65 years of age and 5% were ≥ 75 years of age.
Dette kan være et tegn på skade på blodkarrene kendt som trombotisk mikroangiopati (TMA).
This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
Pulver til oral suspension 5 til under 10
Powder for oral suspension 5 to less than 10
Hvis PAH bekræftes, bør dasatinib seponeres permanent.
If PAH is confirmed, dasatinib should be permanently discontinued.
Disse instruktioner viser dig hvordan du skal give en dosis SPRYCEL oral suspension til patienten.
These instructions show you how to give a dose of SPRYCEL oral suspension to the patient.
Benzoesyre/benzoesalte kan øge gulsot (gulning af huden og øjnene) hos nyfødte (op til 4 uger gamle).
Benzoic acid/Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Der sås 45 forskellige BCR-ABL-mutationer hos 38% af patienterne inkluderet i studiet.
There were 45 different BCR-ABL mutations in 38% of patients enrolled in this study.
SPRYCEL hæmmer væksten af disse leukæmiske celler.
SPRYCEL inhibits the growth of these leukaemic cells.
Erfaring fra kliniske studier med overdosis af SPRYCEL er begrænset til isolerede tilfælde.
Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases.
Pædiatriske patienter med CML
Paediatric patients with CML
Hvis marvcellulariteten er >10%, kan en genoptagelse af behandlingen med SPRYCEL overvejes.
If marrow cellularity is >10%, resumption of treatment with SPRYCEL may be considered.
Major molekulært respons Alle patienter
Major molecular response All patients
PFS blev analyseret ud fra princippet intent-to-treat, og patienterne blev fulgt til hændelser inkluderende efterfølgende behandling.
PFS was analysed on an intent-to-treat principle and patients were followed to events including subsequent therapy.
Omryst flasken gentagende gange i 30 sekunder.
Shake bottle repeatedly for 30 seconds.
Hvis der stadig er synlige klumper, fortsæt da med at ryste, indtil alle synlige klumper er væk.
If there are still visible clumps, continue shaking until no clumps are visible.
Midlertidige dosisreduktioner for intermediære grader af cytopeni og sygdomsrespons kan implementeres efter behov.
Temporary dose reductions for intermediate degrees of cytopaenia and disease response should be implemented as needed.
Nyreforandringer hos aber behandlet i op til 9 måneder var begrænset til en stigning i baggrundsnyremineralisering.
Renal changes in monkeys treated for up to 9 months were limited to an increase in background kidney mineralisation.
Et tilfælde var letalt og var forbundet med trombocytopeni Common Toxicity Criteria (CTC) grad 4.
One case was fatal and was associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopaenia.
Giv ikke dette lægemiddel til børn under 1 år.
Do not give this medicine to children younger than one year of age.
• Tag SPRYCEL oral suspension på tom eller fuld mave.
• Take SPRYCEL oral suspension on an empty or full stomach.
2 Genoptag behandling med den oprindelige startdosis.
2 Resume treatment at the original starting dose.
Læger og andre sundhedspersoner bør rådgive mandlige patienter af passende alder om de mulige virkninger af SPRYCEL på fertilitet, og denne rådgivning kan inkludere overvejelser omkring deponering af sæd.
Physicians and other healthcare providers should counsel male patients of appropriate age about possible effects of SPRYCEL on fertility, and this counseling may include consideration of semen deposition.
De fleste resistente patienter (72%) havde fået > 600 mg imatinib.
Most resistant patients (72%) had received > 600 mg imatinib.
Størstedelen af patienterne (53%) var tidligere behandlet med imatinib igennem mere end 3 år.
The majority of the patients (53%) had received prior imatinib treatment for more than 3 years.
Overlevelse (%; Kaplan-Meier-estimater) Progressionsfri 1 år 2 år Samlet 1 år 2 år
Survival (%; Kaplan-Meier estimates) Progression-Free 1 year 2 year Overall 1 year 2 year
Filmovertræk Hypromellose Titandioxid (E171) Macrogol 400
Film-coating Hypromellose Titanium dioxide (E171) Macrogol 400
Data fra to studier blev poolet og viste, at dasatinib absorberes hurtigt.
Data was pooled across two studies and showed that dasatinib was rapidly absorbed.
Ingen mutationer blev påvist i nydiagnosticerede CML-CP patienter ved behandlingens afslutning.
There were no mutations detected in newly diagnosed CML-CP patients at the end of treatment.
Den højeste overdosis på 280 mg per dag i en uge blev rapporteret hos to patienter, som begge udviklede et signifikant nedsat antal blodplader.
The highest overdose of 280 mg per day for one week was reported in two patients and both developed a significant decrease in platelet counts.
SPRYCEL tabletter kan tages med eller uden mad.
SPRYCEL tablets can be taken with or without a meal.
Almindelig depression, søvnløshed
Common depression, insomnia
hvis du oplever blå mærker, blødning, feber, træthed og forvirring, når du tager SPRYCEL, skal du kontakte din læge.
if you experience bruising, bleeding, fever, fatigue and confusion when taking SPRYCEL, contact your doctor.
Tag næste planlagte dosis på det planlagte tidspunkt.
Take the next scheduled dose at the regular time.
LAD LUFTTØRRE EFTER HVER BRUG
ALLOW TO AIR DRY AFTER EACH USE
SPRYCEL påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
SPRYCEL has minor influence on the ability to drive and use machines.
Ingen af patienterne afbrød behandlingen med SPRYCEL på grund af disse biokemiske laboratorieparametre.
There were no discontinuations of SPRYCEL therapy due to these biochemical laboratory parameters.
In vitro data indikerer en mulig risiko for interaktioner med CYP2C8-substrater såsom glitazoner.
In vitro data indicate a potential risk for interaction with CYP2C8 substrates, such as glitazones.
Crossover til alternativ behandling var tilladt, hvis patienten viste tegn på sygdomsprogression eller intolerans, som ikke kunne håndteres med dosismodifikation.
Crossover to the alternative treatment arm was allowed if patients showed evidence of disease progression or intolerance that could not be managed by dose modification.
Filmovertrukne tabletter bør ikke opløses, da eksponeringen i patienter der får dispergible tabletter er lavere end hos de, der synker en hel tablet.
Film-coated tablets should not be dispersed as the exposure in patients receiving a dispersed tablet is lower than in those swallowing a whole tablet.
Da raten var baseret på 85 patienter med evaulerbare Ig/TCR-vurderinger, var estimatet 89,4%.
When this rate was based on the 85 patients with evaluable Ig/TCR assessments, the estimate was 89.4%.
Tag ikke opløste tabletter.
Do not take dispersed tablets.
Din læge vil fastsætte den rigtige formulering og dosis baseret på din vægt, eventuelle bivirkninger og respons på behandlingen.
Your doctor will decide the right formulation and dose based on your weight, any side effects and response to treatment.
Hypokaliæmi eller hypomagnesiæmi skal korrigeres inden administration af dasatinib.
Hypokalaemia or hypomagnesaemia should be corrected prior to dasatinib administration.
Lægen vil informere dig om risikoen ved at tage SPRYCEL under graviditet.
Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy.
Pilene viser, hvilken tablet der skal tages næste gang i dit behandlingsprogram.
There are arrows to show the next tablet to be taken according to your treatment schedule.
Trin 2: Vend straks flasken på hovedet og ryst den kraftigt i mindst 60 sekunder for at opnå en ensartet suspension.
Step 2: Immediately invert the bottle and shake vigorously for no less than 60 seconds to obtain a uniform suspension.
Fjern den børnesikrede lukning og folieforseglingen.
Remove child-resistant closure and foil seal.
Der er ikke observeret klinisk relevante, aldersrelaterede, farmakokinetiske forskelle hos disse patienter.
No clinically relevant age-related pharmacokinetic differences have been observed in these patients.
Det primære effektendepunkt var hændelsesfri overlevelse (EFS) efter 3 år, som var 65,5% (55,5; 73,7).
The primary efficacy endpoint was 3-year event-free survival (EFS), which was 65.5% (55.5, 73.7).
Cytogenetisk respons inden for 12 måneder cCCyRa p< 0,007*
Cytogenetic response within 12 months cCCyRa p< 0.007*
Hos denne patientpopulation, som fik 100 mg én gang dagligt, blev MCyR opnået hos 77% og CCyR hos 67%.
In this population of patients who received 100 mg once daily, MCyR was achieved in 77% and CCyR in 67%.
Opfølgning skal udføres i henhold til almindeligt gældende retningslinjer.
Follow up should be performed according to standard practice guidelines.
Det bindes både til inaktive og aktive konformationer af BCR-ABL-enzymet.
It binds to both the inactive and active conformations of the BCR-ABL enzyme.
Bland SPRYCEL oral suspension i den lukkede flaske ved at omryste i 30 sekunder.
Mix the SPRYCEL oral suspension in the closed bottle by shaking for 30 seconds.
Nedenstående resultater er baseret på mindst 2 år og 7 års opfølgning efter behandlingsstart med dasatinib.
Results described below are based on a minimum of 2 years and 7 years follow-up after the start of dasatinib therapy.
E255K og F317L blev dog også detekteret før behandlingens start.
However, E255K and F317L were also detected prior to treatment.
Kontakt straks lægen, hvis du får en eller flere af ovenstående bivirkninger.
Contact your doctor immediately if you notice any of the above.
Patienter, der er i stand til at synke tabletter og som gerne vil skifte fra SPRYCEL pulver til oral suspension til SPRYCEL tabletter, eller patienter, der ikke er i stand til at synke tabletter, og som gerne vil skifte fra tabletter til oral suspension, kan frit gøre det, såfremt de korrekte doseringsanbefalinger for doseringsformen følges.
Patients who are able to swallow tablets and who desire to switch from SPRYCEL powder for oral suspension to SPRYCEL tablets or patients who are not able to swallow tablets and who desire to switch from tablets to oral suspension, may do so, provided that the correct dosing recommendations for the dosage form are followed.
Dosismodifikationer var tilladt med henblik på at forbedre aktivitet eller behandling af toksicitet (se pkt.
Dose modifications were allowed for improving activity or management of toxicity (see section 4.2).
Der er utilstrækkelig/begrænset information vedrørende udskillelse af dasatinib i human modermælk og brystmælk hos dyr.
There is insufficient/limited information on the excretion of dasatinib in human or animal breast milk.
A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller(e), der er ansvarlig(e) for batchfrigivelse
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Hyppigheden af hæmatologiske abnormiteter grad 3 og 4 angives i Tabel 8.
The frequency of grade 3 and 4 haematological abnormalities is presented in Table 8.
Samme mutationsfrekvens blev observeret for begge behandlingsarme.
Similar rates of mutation were observed in both the treatment arms.
Andre sekundære endepunkter omfattede varighed af MCyR, PFS samt samlet overlevelse.
Other secondary endpoints included duration of MCyR, PFS, and overall survival.
Hvor længe skal du tage SPRYCEL
How long to take SPRYCEL
Tid-til MMR
Time-to MMR
Hos mennesker med ALL deler de hvide blodlegemer, der kaldes lymfocytter, sig for hurtigt og lever for længe.
In people with ALL, white cells called lymphocytes multiply too quickly and live too long.
Derudover fik 34 (47%) behandling med diuretika, 23 (32%) fik kortikosteroider og 20 (27%) fik både kortikosteroider og diuretika.
Additionally, 34 (47%) received diuretics, 23 (32%) received corticosteroids, and 20 (27%) received both corticosteroids and diuretics.
Gennemsnitlig Tmax blev observeret mellem 0,5 og 6 timer og den gennemsnitlige halveringstid strakte sig fra 2 til 5 timer hen over alle dosisniveauer og aldersgrupper.
Mean Tmax was observed between 0.5 and 6 hours and mean half-life ranged from 2 to 5 hours across all dose levels and age groups.
SPRYCEL må ikke bruges under graviditet, medmindre det er klart nødvendigt.
SPRYCEL is not to be used during pregnancy unless clearly necessary.
Dasatinib absorberes hurtigt hos patienter efter oral administration, med maksimal koncentration efter 0,5 til 3 timer.
Dasatinib is rapidly absorbed in patients following oral administration, with peak concentrations between 0.5-3 hours.
Virkningen af SPRYCEL blev konsistent vist i forskellige undergrupper som f.eks. alder, køn og baseline-Hasford-score.
Efficacy of SPRYCEL was consistently demonstrated across different subgroups, including age, gender, and baseline Hasford score.
a Tal angivet i fed er resultater af de primære endepunkter.
a Numbers in bold font are the results of primary endpoints.
Generelt var fald i calcium ikke forbundet med kliniske symptomer.
In general, there was no association of decreased calcium with clinical symptoms.
Hos patienter, der opnåede tidlig molekylært respons, var der en lavere risiko for transformation, en højere progressionsfri overlevelsesrate (PFS) og en højere samlet overlevelsesrate (OS) som vist i Tabel 10.
Patients achieving early molecular response had a lower risk of transformation, higher rate of progression-free survival (PFS) and higher rate of overall survival (OS), as shown in Table 10.
Der kan være opstået et vakuum, der trækker stemplet tilbage i cylinderen.
There may be a vacuum pulling the plunger back into barrel.
Histamin-2-antagonister og protonpumpe-hæmmere
Histamine-2 antagonists and proton pump inhibitors
Specifikke dosisanbefalinger for ældre er ikke nødvendige.
No specific dose recommendation is necessary in elderly.
Denne dosis repræsenterer 30% lavere eksponering sammenlignet med den anbefalede dosis (se pkt.
This dose represents 30% lower exposure compared to the recommended dose (see section 5.2).
Varigheden af respons og de estimerede overlevelsesrater har givet yderligere evidens for dasatinibs kliniske effekt.
Durability of response and estimated survival rates provide additional evidence of dasatinib clinical benefit.
Pulveret til oral suspension består af pulverblanding med det aktive stof plus hjælpestoffer indeholdt i en flaske til rekonstitution.
The powder for oral suspension consists of powder blend with the active substance plus excipients, contained within a bottle for constitution.
ANC: absolut neutrofiltal
ANC: absolute neutrophil count
Raten for MRD-negativitet (minimal restsygdom) vurderet vha. Ig/TCR var 71,7% ved afslutningen af konsolideringen for alle behandlede patienter.
The minimal residual disease (MRD) negativity rate assessed by Ig/TCR rearrangement was 71.7% by the end of consolidation in all treated patients.
Mind patienten eller omsorgspersonen om, at flasken skal rystes kraftigt inden hver brug.
Remind the patient or caregiver to shake the bottle vigorously prior to each use.