natgillin/translations-raw huggingface dataset:
Disse 6 tilfælde inkluderede tilfælde af forsinket epifysefusion, osteopeni, væksthæmning og gynækomasti (se pkt.
These 6 cases included cases of epiphyses delayed fusion, osteopaenia, growth retardation, and gynecomastia (see section 5.1).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 × 1 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 30 x 1 film-coated tablets
3 Ved trombocytter < 25 × 109/l og/eller recidiv af ANC < 0,5 × 109/l i > 7 dage, gentages trin 1 og behandlingen genoptages med reduceret dosis på 80 mg 1 gang dagligt ved anden episode.
3 If platelets < 25 x 109/L and/or recurrence of ANC < 0.5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
Hvis marvcellulariteten er <10%, skal behandlingen med SPRYCEL afbrydes, indtil ANC > 500/μl (0,5 × 109/l), hvor behandlingen kan genoptages på fuld dosis.
If marrow cellularity is <10%, treatment with SPRYCEL should be interrupted until ANC >500/μL (0.5 x 109/L), at which time treatment may be resumed at full dose.
Samlet overlevelsesrate var konsekvent højere hos dasatinib behandlede patienter, som opnåede BCR-ABL-niveau ≤ 10% ved måned 3, sammenlignet med dem, der ikke gjorde.
Rate of OS was consistently higher in dasatinib treated patients who achieved BCR-ABL level ≤ 10% at 3 months than those who did not.
Tidligere MCyR med imatinib sås hos henholdsvis 28% og 29% af patienterne i dasatinib og imatinib armen.
A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
nydiagnosticeret Ph+ akut lymfoblastisk leukæmi (ALL) i kombination med kemoterapi.
newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.
Derudover tyder in vitro og in vivo undersøgelser på, at behandling med SPRYCEL reversibelt påvirker aktiveringen af blodplader.
Additionally, in vitro and in vivo platelet assays suggest that SPRYCEL treatment reversibly affects platelet activation.
Total ordineret dosis (ml)
Total prescribed dose (mL)
Tid-til cCCyR
Time-to cCCyR
Dasatinibs gennemsnitlige terminale halveringstid er 3-5 timer.
The mean terminal half-life of dasatinib is 3 hours to 5 hours.
Størstedelen af SPRYCEL behandlede patienter oplevede på et tidspunkt bivirkninger.
The majority of SPRYCEL-treated patients experienced adverse reactions at some time.
CML i myeloid blastfase
Myeloid blast phase CML
Patienter med risikofaktorer (f.eks. hypertension, hyperlipidæmi, diabetes) eller med hjertesygdom i anamnesen (f.eks. tidligere perkutan koronar intervention, dokumenteret koronararteriesygdom) bør monitoreres omhyggeligt for kliniske tegn eller symptomer på nedsat hjertefunktion som f.eks. brystsmerter, åndenød og diaforese.
Patients with risk factors (e.g. hypertension, hyperlipidaemia, diabetes) or a history of cardiac disease (e.g. prior percutaneous coronary intervention, documented coronary artery disease) should be monitored carefully for clinical signs or symptoms consistent with cardiac dysfunction such as chest pain, shortness of breath, and diaphoresis.
Dette produkt indeholder lactosemonohydrat.
This medicinal product contains lactose monohydrate.
1 Undersøg om cytopeni er relateret til leukæmi (marvaspirat eller biopsi).
1 Check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
Hver ml oral suspension indeholder omtrent 291 mg saccharose, 2,1 mg natrium, 0,25 mg natriumbenzoat, 0,25 mg benzoesyre, 0,017 mg benzylalkohol og <10 ppm svovldioxid (E220).
Each mL of oral suspension contains approximately 291 mg of sucrose, 2.1 mg of sodium, 0.25 mg of sodium benzoate, 0.25 mg of benzoic acid, 0.017 mg of benzyl alcohol and <10 ppm of sulphur dioxide (E220).
Sjælden hypertyreoidisme, tyroiditis Metabolisme og ernæring
Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
2 år n/a 60% (50-70) 41% (21-60) 10% (0-28) 24% (2-47)
2 year n/a 60% (50-70) 41% (21-60) 10% (0-28) 24% (2-47) Cytogenetic responsec (%)
Effekten af SPRYCEL i kombination med kemoterapi blev vurderet i et pivotalt studie med pædiatriske patienter, der var over 1 år og havde nydiagnosticeret Ph+ ALL.
The efficacy of SPRYCEL in combination with chemotherapy was evaluated in a pivotal study in paediatric patients over one year of age with newly diagnosed Ph+ ALL.
Pulver til oral suspension Ydre karton:
Powder for oral suspension Outer Carton:
Rekonstitueret oral suspension kan yderligere blandes med mælk, yoghurt, æblejuice eller æblemos.
Constituted oral suspension may be further mixed with milk, yogurt, apple juice, or applesauce.
Hver pakning indeholder også en adapter til flasken, som kan presses i (PIBA) og en 12-ml doseringssprøjte i en forseglet plastikpose.
Each pack also contains a press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe in a sealed plastic bag.
Ikke almindelig hepatitis, cholestasis, cholecystitis Hud og subkutane væv
Uncommon hepatitis, cholecystitis, cholestasis Skin and subcutaneous tissue disorders
4 Hvis cytopeni er relateret til leukæmi, skal dosisoptrapning til 180 mg én gang dagligt, overvejes.
4 If cytopaenia is related to leukaemia, consider dose escalation to 180 mg once daily.
I studiet med CML i fremskreden fase og Ph+ ALL var det primære endepunkt MaHR.
In the study in advanced phase CML and Ph+ ALL, the primary endpoint was MaHR.
Hyppigheden af major molekylært respons (defineret som BCR-ABL/kontroltranskriptioner ≤ 0,1% ved RQ-PCR i perifert blod) inden crossover var 29% for dasatinib og 12% for imatinib.
The rate of major molecular response (defined as BCR-ABL/control transcripts ≤ 0.1% by RQ-PCR in peripheral blood samples) prior to crossover was 29% for dasatinib and 12% for imatinib.
Efter rekonstitution, som foretages af apotekspersonalet eller en sundhedsperson, må den orale suspension kun administreres ved brug af den orale doseringssprøjte, der medfølger i hver pakning.
Once constituted by your pharmacist or healthcare professional, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Dosis af pulver til oral suspension til voksne patienter med accelereret, myeloid eller lymfoid blastfase (fremskreden fase) CML eller Ph+ ALL er ikke fastlagt.
The dose for the use of powder for oral suspension in adult patients with accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL has not been determined.
Forudgående imatinib (N = 46)b
Prior imatinib (N = 46)b
I det pivotale studie fik 106 pædiatriske patienter SPRYCEL i kombination med kemoterapi i et kontinuerligt dosisregime.
In the pivotal study, 106 paediatric patients received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Patienterne randomiseredes (2:1) til enten dasatinib (70 mg 2 gange dagligt) eller imatinib (400 mg 2 gange dagligt).
They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily).
I et randomiseret studie med patienter med nydiagnosticeret CML i kronisk fase var medianbehandlingsvarigheden ca. 60 måneder.
In a randomized trial in patients with newly diagnosed chronic phase CML, the median duration of therapy was approximately 60 months.
Efter minimum 7 års opfølgning i det pædiatriske fase-I studie blandt 17 patienter med imatinib resistent eller intolerant CML-CP var medianvarigheden af progressionsfri overlevelse (PFS) 53,6 måneder og raten af OS var 82,4%.
In the Phase I paediatric study, after a minimum of 7 years of follow-up among the 17 patients with imatinib-resistant or intolerant CML-CP, the median duration of PFS was 53.6 months and the rate of OS was 82.4%.
Uanset formulering var den overordnede sikkerhedsprofil af SPRYCEL i den pædiatriske population med Ph+ CML-CP tilsvarende den i den voksne population, med undtagelse af, at der ikke blev rapporteret perikardieansamling, pleuraansamling, pulmonært ødem eller pulmonær hypertension i den pædiatriske population.
The overall safety profile of SPRYCEL in the paediatric Ph+ CML-CP population was similar to that of the adult population, regardless of formulation, with the exception of no reported pericardial effusion, pleural effusion, pulmonary oedema, or pulmonary hypertension in the paediatric population.
Mediantiden til MMR var efter 60 måneders opfølgning 9,3 måneder i SPRYCEL gruppen og 15,0 måneder i imatinib gruppen hos patienter med en MMR.
Median time to MMR after 60 months of follow-up was 9.3 months in the SPRYCEL group and 15.0 months in the imatinib group in patients with a MMR.
Dasatinib er en potent, subnanomolær hæmmer af BCR-ABL-kinase med effekt ved en koncentration på 0,6-0,8 nM.
Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM.
Hjælpestoffer: indeholder saccharose, natrium, natriumbenzoat, benzoesyre, benzylalkohol og svovldioxid (E220).
Excipients: contains sucrose, sodium, sodium benzoate, benzoic acid, benzyl alcohol and sulphur dioxide (E220).
Efter 60 måneders opfølgning var mediantiden til cCCyR 3,1 måneder i SPRYCEL gruppen og 5,8 måneder i imatinib gruppen hos patienter med en bekræftet CCyR.
After 60 months of follow-up, median time to cCCyR was 3.1 months in the SPRYCEL group and 5.8 months in the imatinib group in patients with a confirmed CCyR.
Hvis SPRYCEL ikke tåles efter dosisreduktion, skal enten den potente CYP3A4-hæmmer seponeres, eller behandlingen med SPRYCEL afbrydes, indtil hæmmeren seponeres.
If SPRYCEL is not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or interrupt SPRYCEL until the inhibitor is discontinued.
Hvis du ved en fejl har taget for meget SPRYCEL, skal du straks kontakte lægen.
If you have accidentally taken too much SPRYCEL, talk to your doctor immediately.
Sjælden leukocytoklastisk vaskulitis, hudfibrose
Rare leukocytoclastic vasculitis, skin fibrosis
Hos patienter over 65 år er der større sandsynlighed end hos yngre patienter for at opleve pleuraeffusion, dyspnø, hoste, perikardieeffusion og kongestiv hjertesvigt, og disse patienter bør derfor monitoreres omhyggeligt.
Patients aged 65 years and older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive heart failure, and should be monitored closely.
Ved år 1 5%, p<0,2394
By 1 year 5%, p<.2394
Et åbent, enkeltarms-, multicenter-studie med patienter med resistens eller intolerans over for imatinib (dvs. patienter som oplevede signifikant toksicitet under behandling med imatinib hvor fortsat behandling var udelukket).
An open-label, single-arm, multicentre study was conducted in patients resistant or intolerant to imatinib (i.e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
Behandlingen med 140 mg én gang dagligt viste en virkningsprofil, der svarede til behandling med 70 mg to gange dagligt, men med en mere gunstig sikkerhedsprofil.
The 140 mg once daily regimen showed a comparable efficacy profile to the 70 mg twice daily regimen but a more favourable safety profile.
Hvis SPRYCEL skal administreres med en potent CYP3A4-hæmmer, skal der overvejes en dosisreduktion til:
If SPRYCEL must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:
Hos patienter med CML med resistens eller intolerans over for tidligere imatinib behandling var cytopenier (trombocytopeni, neutropeni og anæmi) et vedvarende fund.
In patients with CML with resistance or intolerance to prior imatinib therapy, cytopaenias (thrombocytopaenia, neutropaenia, and anaemia) were a consistent finding.
Den mediane behandlingsvarighed i behandlingsgruppen med 100 mg én gang dagligt var 37 måneder (1-91 måneder).
The median duration of therapy in the 100 mg once daily group was 37 months (range 1-91 months).
SPRYCEL 10 mg/ml pulver til oral suspension
SPRYCEL 10 mg/mL powder for oral suspension
Disse ikke-kliniske studier har vist, at dasatinib kan overvinde imatinibresistens, der stammer fra BCR-ABL overekspression, BCR-ABL kinasedomænemutationer, aktivering af andre signalveje, der involverer kinaser i SRC-kinasefamilien (LYN, HCK), og overekspression af gener relateret til multimedicinresistens.
These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signalling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
Den overordnede gennemsnitlige halveringstid af dasatinib er cirka 5-6 timer hos patienter.
The overall mean terminal half-life of dasatinib is approximately 5-6 hours in patients.
• For at undgå at beskadige sprøjten må den ikke skilles ad.
• Do not take the syringe apart in order to avoid damaging it.
Den anbefalede pædiatriske dosis SPRYCEL oral suspension indeholder 1,17 g saccharose pr. 40 mg dasatinib og 4,37 g saccharose pr. 150 mg dasatinib.
For the recommended paediatric dosage, SPRYCEL oral suspension contains 1.17 grams sucrose per 40 mg dasatinib and 4.37 grams sucrose per 150 mg dasatinib.
Meget almindelig infektion (inklusive bakteriel, viral, mykotisk, ikke-specifik)
Infections and infestations Very common infection (including bacterial, viral, fungal, non-specified)
Seks procent af de dasatinib behandlede patienter fik seponeret behandlingen på grund af lægemiddelrelateret pleuraeffusion.
Six percent of dasatinib-treated patients discontinued treatment due to drug-related pleural effusion.
Hver filmovertrukken tablet indeholder 20 mg, 50 mg, 70 mg, 80 mg, 100 mg eller 140 mg dasatinib (som monohydrat).
Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).
i Deklivt ødem, lokaliseret ødem, perifert ødem.
i Gravitational oedema, localised oedema, oedema peripheral.
Tabel 8: Hæmatologiske laboratorieabnormiteter af CTC-grad 3/4 i kliniske studier med patienter med resistens eller intolerans over for tidligere behandling med imatiniba
Table 8: CTC grades 3/4 haematological laboratory abnormalities in clinical studies in patients with resistance or intolerance to prior imatinib therapya
Sørg for en udvaskningsperiode på cirka 1 uge efter hæmmeren er seponeret, før dosis af SPRYCEL øges.
Allow a washout period of approximately 1 week after the inhibitor is stopped before the SPRYCEL dose is increased.
SPRYCEL oral suspension kan blandes med mælk, yoghurt, æblejuice eller æblemos.
SPRYCEL oral suspension may be mixed with milk, yogurt, apple juice, or applesauce.
Samtidig brug af dasatinib og et CYP3A4-substrat kan øge eksponeringen af CYP3A4-substratet.
Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
Ikke almindelig overfølsomhed (inklusive erythema nodosum) Sjælden anafylaktisk shock Det endokrine system
Uncommon hypersensitivity (including erythema nodosum) Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism
Indeholder 0,29 g saccharose pr. ml oral suspension.
Contains 0.29 g of sucrose per mL of oral suspension.
I et studie med raske frivillige øgede en enkeltdosis på 100 mg dasatinib AUC og Cmax af simvastatin, der er et kendt CYP3A4-substrat, med henholdsvis 20 og 37%.
In a study in healthy subjects, a single 100 mg dose of dasatinib increased AUC and Cmax exposure to simvastatin, a known CYP3A4 substrate, by 20 and 37% respectively.
Mediantiden til første forekomst af grad ≥ 3 dasatinib relateret pleuraeffusion var 175 uger (114-274 uger).
The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion was 175 weeks (range: 114 to 274 weeks).
Der foreligger ingen dosisanbefalinger for SPRYCEL til børn under 1 år.
There is no dose recommendation for SPRYCEL with children under 1 year of age.
Syvoghalvfems af de 130 pædiatriske patienter med CML-CP blev behandlet med SPRYCEL tabletter 60 mg/m2 en gang dagligt (maximumdosis på 100 mg en gang dagligt for patienter med højt BSA).
Ninety-seven of the 130 paediatric patients with CML-CP were treated with SPRYCEL tablets 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) Infektioner (både infektioner forårsaget af bakterier og af virus samt svampeinfektioner) Hjerte og lunger: åndenød
Very common side effects (may affect more than 1 in 10 people) Infections (including bacterial, viral and fungal) Heart and lungs: shortness of breath
Hver pakning indeholder også en lavdensitets-polyethylenadapter til flasken, som kan presses i (PIBA), og en 12-ml doseringssprøjte (polypropylen sprøjtecylinder med et højdensitetspolyethylenstempel) i en forseglet plastikpose.
Each pack also contains a low-density polyethylene press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe (polypropylene syringe barrel with high-density polyethylene syringe plunger rod) in a sealed plastic bag.
Rådgiv gravide patienter og patienter der kan blive gravide om de potentielle risici for fosteret ved dasitinib og hjælpestoffet benzylalkohol, som kan akkumuleres over tid og kan forårsage metabolisk acidose.
Advise patients who are or may become pregnant of the potential risk to the foetus from dasatinib and the excipient benzyl alcohol, which may accumulate over time and cause metabolic acidosis.
Det anbefales at bruge latex- eller nitrilhandsker til håndtering og passende bortskaffelse af pulver, der utilsigtet spildes fra flasken, for at minimere risikoen for hudeksponering.
The use of latex or nitrile gloves is recommended when handling any powder that is inadvertently spilled from the bottle, for appropriate disposal in order to minimise the risk of dermal exposure.
I kliniske studier med voksne CML- og Ph+ ALL-patienter var dosiseskalering til 140 mg én gang dagligt (CML i kronisk fase) eller 180 mg én gang dagligt (fremskreden CML eller Ph+ ALL) tilladt hos patienter, som ikke opnåede hæmatologisk eller cytogenetisk respons ved den anbefalede startdosis.
In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
Spørg lægen, hvis du har spørgsmål om, hvordan SPRYCEL virker, eller hvorfor du har fået ordineret denne medicin.
If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor.
Sjælden forsinket epifysefusion,h væksthæmningh
Rare epiphyses delayed fusion,h growth retardationh
Følgende dosiseskaleringer, vist i Tabel 2, anbefales til pædiatriske patienter med Ph+ CML-CP, som ikke opnår et hæmatologisk, cytogenetisk og molekylært respons på de anbefalede tidspunkter, ifølge gældende behandlingsvejledninger, og som tåler behandlingen.
The following dose escalations shown in Table 2 are recommended in paediatric patients with Ph+ CML-CP who do not achieve a haematologic, cytogenetic and molecular response at the recommended time points, per current treatment guidelines, and who tolerate the treatment.
Knogler, led, muskler og bindevæv: forsinket sammenvoksning af de afrundede ender, der udgør led (epifyser); langsommere eller forsinket vækst.
Musculoskeletal and connective tissue: delayed fusion of the rounded ends that form joints (epiphyses); slower or delayed growth
Diverse bivirkninger som f.eks. pleuraeffusion, ascites, lungeødem og perikardie-effusion med eller uden superficielt ødem kan samlet set betegnes som ”væskeretention”.
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and pericardial effusion with or without superficial oedema may be collectively described as “fluid retention”.
For patienter, der tager SPRYCEL 60 mg eller 40 mg dagligt, skal det overvejes at seponere SPRYCEL dosen, indtil CYP3A4-hæmmeren er seponeret, eller at skifte til en lavere dosis med formuleringen pulver til oral suspension.
For patients taking SPRYCEL 60 mg or 40 mg daily, consider interrupting the dose of SPRYCEL until the CYP3A4 inhibitor is discontinued, or switching to a lower dose with the powder for oral suspension formulation.
Myeloid blastfase (n= 74)c
Myeloid blast phase (n= 74)c
Hvis cytopeni bliver ved i mere end 3 uger, check da om cytopeni er relateret til leukæmien (knoglemarvsaspirat eller -biopsi)
If cytopaenia persists for more than 3 weeks, check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
Medianbehandlingsvarigheden for alle patienter ved en opfølgningsperiode på 7 år var ca. 29,8 måneder (1-92,9 måneder).
Median duration of treatment for all patients at 7 years of follow-up was 29.8 months (range < 1-92.9 months).
Det anbefales at basere øgning eller reduktion af dosis på den enkelte patients respons og tolerance.
Dose increase or reduction is recommended based on individual patient response and tolerability.
Der opstod gastrointestinal blødning grad 3 eller 4 hos 6% af patienterne med CML i fremskreden fase, hvilket almindeligvis krævede behandlingsafbrydelser og transfusioner.
Grade 3 or 4 gastrointestinal haemorrhage occurred in 6% of patients with advanced phase CML and generally required treatment interruptions and transfusions.
Et fedtfattigt måltid 30 minutter inden dasatinib resulterede i en stigning i gennemsnitligt AUC for dasatinib på 21%.
A low-fat meal 30 minutes prior to dasatinib resulted in a 21% increase in the mean AUC of dasatinib.
For patienter, der tager SPRYCEL 60 mg eller 40 mg dagligt, skal det overvejes at seponere SPRYCEL dosen, indtil CYP3A4-hæmmeren er seponeret, eller at skifte til en lavere dosis med formuleringen pulver til oral suspension (se produktresuméet for SPRYCEL pulver til oral suspension).
For patients taking SPRYCEL 60 mg or 40 mg daily, consider interrupting the dose of SPRYCEL until the CYP3A4 inhibitor is discontinued, or switching to a lower dose with the powder for oral suspension formulation (see Summary of Product Characteristics for SPRYCEL powder for oral suspension).
Dosering til børn med CML eller Ph+ ALL i kronisk fase er baseret på legemsvægt.
Dosing for children with chronic phase CML or Ph+ ALL is on the basis of body weight.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én flaske med pulver til oral suspension indeholder 990 mg dasatinib (som monohydrat).
QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
Kontakt lægen eller apotekspersonalet, før du tager SPRYCEL hvis du tager blodfortyndende medicin eller medicin, der forebygger blodpropper (se ”Brug af anden medicin sammen med SPRYCEL”) hvis du har eller tidligere har haft lever- eller hjerteproblemer hvis du får åndedrætsbesvær, brystsmerter eller hoste, mens du tager SPRYCEL: dette kan være et tegn på ophobning af væske i lungerne eller brystet (som kan være mere almindeligt hos patienter over 65 år) eller skyldes ændringer i de blodårer, der forsyner lungerne med blod hvis du nogensinde har været eller måske er smittet med hepatitis B-virus.
Warnings and precautions Talk to your doctor or pharmacist before using SPRYCEL if you are taking medicines to thin the blood or prevent clots (see "Other medicines and SPRYCEL") if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older), or due to changes in the blood vessels supplying the lungs if you have ever had or might now have a hepatitis B infection.
SPRYCEL bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med dasatinib (se pkt.
SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib (see section 4.6).
SPRYCEL ordineres udelukkende af læger, der har erfaring med behandling af leukæmi.
SPRYCEL will only be prescribed by a doctor with experience in treating leukaemia.
Dasatinib er forbundet med væskeretention.
Dasatinib is associated with fluid retention.