FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
Icelandic: Töflurnar eru ekki ætlaðar sjúklingum sem vega minna en 10 kg; hjá þeim sjúklingum á að nota mixtúru.
English: In the Phase III newly diagnosed chronic phase CML study, the following grade 3 or 4 laboratory abnormalities were reported after a minimum of 12 months follow-up in patients taking SPRYCEL: neutropaenia (21%), thrombocytopaenia (19%), and anaemia (10%).
Icelandic: Í III. stigs rannsókn á sjúklingum með nýlega greint CML í stöðugum fasa sem fengu SPRYCEL var greint frá eftirfarandi óeðlilegum blóðgildum af 3. eða 4. gráðu: daufkyrningafæð (21%), blóðflagnafæð (19%) og blóðleysi (10%) eftir a.m.k.
English: The active substance is dasatinib.
Icelandic: Virka innihaldsefnið er dasatinib.
English: If a moderate, grade 2, non-haematologic adverse reaction develops with dasatinib, treatment should be interrupted until the adverse reaction has resolved or returned to baseline.
Icelandic: Ef meðalalvarleg aukaverkun af 2. gráðu, sem tengist ekki blóðmynd, kemur fram við notkun dasatinibs, skal gera hlé á meðferð þar til aukaverkunin er horfin eða ástandið orðið eins og við upphaf meðferðar.
English: Common contusion a Includes decreased appetite, early satiety, increased appetite.
Icelandic: Mar a M.a. minnkuð matarlyst, mettast fljótt, aukin matarlyst.
English: • 20 mg daily for patients taking SPRYCEL 100 mg tablet daily.
Icelandic: 20 mg daglega fyrir sjúklinga sem fá SPRYCEL 100 mg töflu daglega.
English: Grade 3 or 4 hypocalcaemia, hypokalaemia, and hypophosphataemia were reported in patients with all phases of CML but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML and Ph+ ALL.
Icelandic: Greint var frá kalsíum-, kalíum- og fosfatlækkun í blóði af gráðu 3 eða 4 hjá sjúklingum með CML (allir fasar) en með aukinni tíðni hjá sjúklingum með CML eða Ph+ ALL í eitilfrumufasa eða kyrningafasa.
English: One 120-mL plastic bottle (with child-resistant closure) contains 33 g of powder for oral suspension.
Icelandic: Eitt 120 ml plastglas (með barnaöryggisloki) inniheldur
English: Carton containing 30 x 1 film-coated tablets in perforated unit dose blisters.
Icelandic: Askja með 30 x 1 filmuhúðuðumtöflum í rifgötuðum stakskammtaþynnum.
English: Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Icelandic: Hver filmuhúðuð tafla inniheldur 135,0 mg af laktósaeinhýdrati.
English: In patients with Ph+ ALL treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months the median PFS was 4 months, and the median overall survival was 7 months.
Icelandic: Hjá sjúklingum með Ph+ ALL sem fengu meðferð með 140 mg einu sinni á sólarhring var miðgildi MaHR 5 mánuðir, miðgildi lifunar án versnunar var 4 mánuðir og miðgildi heildarlifunar var 7 mánuðir.
English: Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
Icelandic: Miðgildi meðferðarlengdar með dasatinib var 14 mánuðir og voru 31% sjúklinganna meðhöndlaðir í > 24 mánuði.
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.
Icelandic: 400 mg áður en þeir tóku þátt í rannsókninni náðist meiriháttar litningasvörun hjá 61% sjúklinga í dasatinib hópnum og hjá 50% í imatinib hópnum.
English: Outer Carton: sprycel 100 mg
Icelandic: Ytri umbúðir: sprycel 100 mg
English: Responses were durable across all phases of CML and Ph+ ALL.
Icelandic: Svörunin entist vel í öllum fösum CML og Ph+ ALL.
English: 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.
Icelandic: Filmuhúðuðu töflurnar samanstanda af töflukjarna og filmuhúð til að verja heilbrigðisstarfsmenn fyrir virka efninu.
English: Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
Icelandic: Miðgildi meðferðarlengdar með dasatinib var 3,5 mánuðir og voru 12% sjúklinganna meðhöndlaðir í > 24 mánuði.
English: Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations
Icelandic: Algengar hjartabilun/skert hjartastarfsemi*c, vökvasöfnun í gollurshúsi*, hjartsláttartruflanir (þ.m.t. hraðtaktur), hjartsláttarónot
English: Powder for oral suspension Outer Carton:
Icelandic: Mixtúruduft, dreifa Ytri umbúðir:
English: Lymphoid toxicity in rats consisted of lymphoid depletion of the lymph nodes, spleen, and thymus, and decreased lymphoid organ weights.
Icelandic: Eiturverkanir í eitlum hjá rottum samanstóðu af eyðingu eitla, milta og hóstarkirtils og minnkaðri þyngd eitillíffæra.
English: Daily dose (mg)
Icelandic: Dagsskammtur (mg)
English: SPRYCEL powder for oral suspension contains approximately 0.29 g/mL of sucrose upon constitution with water.
Icelandic: SPRYCEL mixtúruduft, dreifa inniheldur u.þ.b.0,29 g/ml af súkrósa eftir blöndun við vatn.
English: After constitution, one bottle contains 99 mL of oral suspension.
Icelandic: Eftir blöndun inniheldur eitt glas 99 ml af mixtúru, dreifu.
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.
Icelandic: Hjá rottum fylgdi minniháttar til væg lækkun á gildi rauðra blóðkorna, breytingum á beinmerg; svipaðar breytingar urðu hjá öpum en þó ekki eins tíðar.
English: The time to MMR was consistently shorter in dasatinib-treated patients compared with imatinib-treated patients.
Icelandic: Tími að MMR var markvisst styttri hjá sjúklingum sem fengu meðferð með dasatinib samanborið við sjúklinga sem fengu meðferð með imatinib.
English: Outer Carton: sprycel 80 mg
Icelandic: Ytri umbúðir: sprycel 80 mg
English: SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient.
Icelandic: Lyfjafræðingur eða til þess hæfur heilbrigðisstarfsmaður á að blanda SPRYCEL mixtúruna áður en sjúklingurinn fær hana.
English: 2 If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 20 x 109/L and resume at the original starting dose.
Icelandic: 2 Ef frumufæð tengist ekki hvítblæði, skal hætta meðferðinni þar til ANC ≥ 1,0 x 109/l og blóðflögur ≥ 20 x 109/l.
English: 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.
Icelandic: Eftir að fylgst hafði verið með sjúklingunum í að lágmarki 24 mánuði hafði aðeins 21 af þeim 240 sjúklingum sem höfðu náð meiriháttar litningasvörun versnað og miðgildi tímalengdar sem meiriháttar litningasvörun varir ekki náðst.
English: Treatment with SPRYCEL is associated with anaemia, neutropaenia and thrombocytopaenia.
Icelandic: Meðferð með SPRYCEL tengist blóðleysi, daufkyrningafæð og blóðflagnafæð.
English: In Ph+ ALL paediatric patients with non-haematologic adverse reactions, if needed, one level of dose reduction should be followed, according to the dose reduction recommendations for haematologic adverse reactions that are described above.
Icelandic: Hjá börnum með Ph+ ALL með aukaverkanir sem ekki tengjast blóðmynd á að minnka skammta um eitt skammtþrep ef nauðsyn krefur samkvæmt leiðbeiningum um skammtaminnkun fyrir aukaverkanir á blóðmynd sem lýst er hér á undan.
English: within 24 months (95% CI)
Icelandic: innan 24 mánaða (95% CI)
English: Secondary endpoints included time in cCCyR (measure of durability of response), time to cCCyR, major molecular response (MMR) rate, time to MMR, progression free survival (PFS) and overall survival (OS).
Icelandic: Aðrir annars stigs endapunktar voru m.a. lengd MCyR, lifun án versnunar (progression free survival (PFS)) og heildarlifun.
English: The median time from diagnosis to start of treatment was 82 months.
Icelandic: Tími (miðgildi) frá sjúkdómsgreiningu þar til meðferð hófst var 82 mánuðir.
English: Therefore, CYP3A4 substrates known to have a narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving dasatinib (see section 4.4).
Icelandic: Því þarf að gæta varúðar þegar hvarfefni CYP3A4 sem vitað er að eru með þröngt skammtabil (t.d. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil eða ergotalkalóíðar [ergotamin, dihydroergotamin]) eru gefin sjúklingum sem fá dasatinib (sjá kafla 4.4).
English: Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date.
Icelandic: Miðgildi meðferðarlengdar með dasatinib var 24 mánuðir og voru 51% sjúklinganna meðhöndlaðir í > 24 mánuði.
English: within 48 months (95% CI)
Icelandic: innan 48 mánaða (95% CI)
English: If cytopaenia recurs, repeat marrow aspirate/biopsy and resume treatment at a reduced dose.
Icelandic: Ef frumufæð kemur aftur fram á að endurtaka mergsog/vefjasýni og hefja meðferð á ný með minni skammti.
English: Rare abortion
Icelandic: Mjög sjaldgæfar
English: What SPRYCEL contains The active substance is dasatinib.
Icelandic: SPRYCEL inniheldur Virka innihaldsefnið er dasatinib.
English: Your pharmacist or qualified healthcare professional will constitute (mix to form a liquid) SPRYCEL powder for oral suspension to form SPRYCEL oral suspension before dispensing to you.
Icelandic: Lyfjafræðingur eða til þess hæfur heilbrigðisstarfsmaður blandar SPRYCEL mixtúruna áður en þú færð hana.
English: Durability of cCCyR
Icelandic: Tími að cCCyR
English: SPRYCEL 140 mg film-coated tablets
Icelandic: SPRYCEL 140 mg filmuhúðaðar töflur
English: Not known hepatitis B reactivation
Icelandic: Tíðni ekki þekkt endurvirkjun á lifrarbólgu
English: The median time from diagnosis to start of treatment was 18 months.
Icelandic: Tími (miðgildi) frá sjúkdómsgreiningu þar til meðferð hófst var 18 mánuðir.
English: Durability of response and estimated survival rates provide additional evidence of dasatinib clinical benefit.
Icelandic: Varanleiki svörunar og mat á tíðni lifunar veita viðbótar vísbendingar um klínískan ávinning dasatinibs.
English: A reaction with fever, blisters on the skin, and ulceration of the mucous membranes Disease of the kidneys with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low protein level in the blood Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets, and formation of blood clots
Icelandic: Viðbrögð með hita, blöðrum á húð og sáramyndun á slímhúð Sjúkdómur í nýrum með einkennum eins og bjúg og óeðlilegum rannsóknarniðurstöðum eins og eggjahvíta í þvagi og lág gildi próteina í blóði
English: When this rate was based on the 85 patients with evaluable Ig/TCR assessments, the estimate was 89.4%.
Icelandic: Þegar þetta hlutfall var byggt á 85 sjúklingum með matshæft
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Icelandic: Sjúklingar með arfgengt frúktósaóþol, glúkósa-galaktósa vanfrásog eða súkrósa-ísómaltasaþurrð, sem er mjög sjaldgæft, skulu ekki taka lyfið.
English: HAZARD RATIO (95% CI)
Icelandic: ÁHÆTTUHLUTFALL(95% CI)
English: Constitution in this way produces 90 mL (deliverable volume) of 10 mg/mL SPRYCEL oral suspension.
Icelandic: Með þessari blöndun fást 90 ml (magn sem hægt er að gefa) af 10 mg/ml SPRYCEL mixtúru.
English: Lymphoid blast (n= 33)
Icelandic: Eitilfrumufasi (n= 33)
English: All patients Imatinib-resistant patients a Results reported in recommended starting dose of 100 mg once daily.
Icelandic: Imatinib-ónæmir sjúklingar a Greint frá niðurstöðum við ráðlagðan upphafsskammt 100 mg einu sinni á sólarhring.
English: Rare diabetes mellitus
Icelandic: Mjög sjaldgæfar sykursýki
English: Excipients: contains lactose monohydrate.
Icelandic: Hjálparefni: inniheldur mjólkursykureinhýdrat.
English: How to store SPRYCEL
Icelandic: Hvernig nota á SPRYCEL
English: In addition, one open-label, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML.
Icelandic: stigs samanburðarrannsókn með dasatinibi gerð á fullorðnum sjúklingum með nýlega greint CML í stöðugum fasa.
English: within 36 months (95% CI)
Icelandic: innan 36 mánaða (95% CI)
English: Holding the syringe tip firmly in the bottle, turn the bottle with the syringe upright again.
Icelandic: Meðan sprautuendanum er haldið vandlega í glasinu á að snúa glasinu ásamt sprautunni í upprétta stöðu.
English: Very common skin rashe Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria, hyperhidrosis
Icelandic: Mjög algengar húðútbrote Algengar skalli, húðbólga (þ.m.t. exem), kláði, þrymlabólur, þurr húð, ofsakláði, ofsvitnun
English: Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus - CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Icelandic: Algengar lungnabólga (þ.m.t. af völdum baktería (sýkla), veira og sveppa), sýking/bólga í efri öndunarvegi, herpes veirusýking (þ.m.t. cýtómegalóveira - CMV), sýking vegna garnar- og ristilbólgu, sýklasótt (þ.m.t. sjaldgæf tilfelli sem geta verið banvæn)
English: A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the powder for oral suspension, in section 4.2 of the Summary of Product Characteristics for the powder for oral suspension, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
Icelandic: Lyfjahvarfahermun byggð á líkani segir fyrir um að búast má við að skammtaleiðbeiningar samkvæmt líkamsþyngd sem lýst er fyrir mixtúru í kafla 4.2 í samantekt á eiginleikum mixtúrudufts, dreifu hafi í för með sér svipaða útsetningu og töfluskammtur á 60 mg/m2.
English: SPRYCEL 20 mg tablets dasatinib
Icelandic: SPRYCEL 20 mg töflur dasatinib
English: In the Phase III dose-optimisation study in chronic phase CML,
Icelandic: Í skammtarannsókn (dose-optimisation study) í III.
English: Heart and lungs: heart attack (including fatal outcome), inflammation of the lining (fibrous sack) surrounding the heart, irregular heartbeat, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of airway that may cause breathing difficulties, asthma, increased blood pressure in the arteries (blood vessels) of the lungs Digestive problems: inflammation of the pancreas, peptic ulcer, inflammation of the food pipe, swollen tummy (abdomen), tear in the skin of the anal canal, difficulty in swallowing, inflammation of the gallbladder, blockage of bile ducts, gastro-oesophageal reflux (a condition where acid and other stomach contents come back up into the throat) Skin, hair, eye, general: allergic reaction including tender, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, lower sexual drive, fainting, tremor, inflammation of the eye which causes redness or pain, a skin disease characterized by tender, red, well-defined blotches with the sudden onset of fever and raised white blood cell count (neutrophilic dermatosis), loss of hearing, sensitivity to light, visual impairment, increased eye tearing, disturbance in skin colour, inflammation of fatty tissue under the skin, skin ulcer, blistering of the skin, nail disorder, hair disorder, hand-foot disorder, renal failure, urinary frequency, breast enlargement in men, menstrual disorder, general weakness and discomfort, low thyroid function, losing balance while walking, osteonecrosis (a disease of reduced blood flow to the bones, which can cause bone loss and bone death), arthritis, skin swelling anywhere in the body
Icelandic: Húð, hár, augu, almennar aukaverkanir: ofnæmisviðbrögð þar á meðal rauðir hnútar í húðinni (þrymlaroði), kvíði, ringlun, skapsveiflur, minnkuð kynhvöt, yfirlið, skjálfti, bólga í auga sem veldur roða eða sársauka, húðsjúkdómur sem einkennist af viðkvæmum, rauðum vel afmörkuðum blettum með skyndilegum hita og fjölgun hvítra blóðkorna (daufkyrninga húðsjúkdómur), heyrnarleysi, viðkvæmni fyrir ljósi, sjónskerðing, aukið tárarennsli úr augum, litarbreytingar í húð, bólga í fituvef undir húð, sár á húð, húðvörtur, naglakvillar, breyting á hári, handa- og fótaheilkenni, nýrnabilun, tíð þvaglát, brjóstastækkun hjá karlmönnum, tíðatruflanir, almennur slappleiki og óþægindi, skert starfsemi skjaldkirtils, jafnvægisleysi við gang, beindrep (sjúkdómur með skertu blóðflæði til beina, sem getur orsakað rýrnun beina og beindauða), liðbólga, bólgin húð hvar sem er á líkamanum
English: Rare pulmonary embolism, acute respiratory distress syndrome
Icelandic: Mjög sjaldgæfar lungnasegarek, bráð andnauð
English: These data should be considered if patients are to switch from tablets to powder for oral suspension or vice versa.
Icelandic: Þetta á að hafa í huga hjá sjúklingum sem skipta úr töflum í mixtúru og öfugt.
English: Bleeding drug-related adverse reactions, ranging from petechiae and epistaxis to grade 3 or 4 gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking SPRYCEL (see section 4.4).
Icelandic: Greint var frá lyfjatengdum blæðingum sem aukaverkun allt frá punktblæðingum og blóðnösum til 3. eða 4. gráðu blæðinga frá meltingarvegi og miðtaugakerfi hjá sjúklingum sem fengu SPRYCEL (sjá kafla 4.4).
English: Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
Icelandic: Hver ml af mixtúru inniheldur 10 mg af dasatinibi (sem einhýdrat).
English: Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropaenia, gastrointestinal bleeding, high uric acid levels in the blood
Icelandic: vökva í kringum hjartað, vökva í lungum, hjartsláttaróreglu, daufkyrningafæð með hita, blæðingar í meltingarvegi, mikið magn þvagsýru í blóði
English: 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.
Icelandic: Eftirfarandi skammtaaukning sem sýnd er í töflu 2 er ráðlögð hjá börnum með Ph+ CML-CP sem þola meðferðina þegar blóðsvörun, litningasvörun og sameindasvörun hefur ekki náðst við ákveðin tímamörk samkvæmt gildandi meðferðarleiðbeiningum.
English: OUTER CARTON AND LABEL FOR BOTTLE PACK
Icelandic: ASKJA OG MIÐI FYRIR TÖFLUGLAS
English: Table 2: Dose escalation for patients with Ph+CML-CP Dose (maximum dose per day) Starting dose
Icelandic: Skammtaaukning hjá sjúklingum með Ph+ CML-CP Skammtur (hámarksskammtur á dag) Upphafsskammtur
English: A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
Icelandic: Fyrir náðist meiriháttar litningasvörun (MCyR) við imatinibi hjá 28% sjúklinganna sem voru í dasatinib hópnum og 29% þeirra sem voru í imatinib hópnum.
English: Pulmonary arterial hypertension (PAH)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: d Excludes gastrointestinal bleeding and CNS bleeding; these adverse reactions are reported under the gastrointestinal disorders system organ class and the nervous system disorders system organ class, respectively.
Icelandic: d Blæðingar í meltingarfærum og miðtaugakerfi undanskildar, greint er frá þessum aukaverkunum undir meltingarfærum og taugakerfi.
English: SPRYCEL 70 mg film-coated tablets EU/1/06/363/006
Icelandic: SPRYCEL 70 mg filmuhúðaðar töflur EU/1/06/363/006
English: Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating SPRYCEL.
Icelandic: Gera á ráð fyrir u.þ.b. einnar viku útskolunartímabili eftir að notkun hemils er hætt áður en notkun SPRYCEL er hafin á ný.
English: SPRYCEL 50 mg tablets dasatinib
Icelandic: SPRYCEL 50 mg töflur dasatinib
English: In CML-CP paediatric patients with non-haematologic adverse reactions, the dose reduction recommendations for haematologic adverse reactions that are described above should be followed.
Icelandic: Hjá börnum með CML-CP með aukaverkanir sem ekki tengjast blóðmynd á að fylgja ráðleggingum um skammtaminnkun vegna aukaverkana á blóð sem lýst er hér á undan.
English: Patients should be advised that they may experience adverse reactions such as dizziness or blurred vision during treatment with dasatinib.
Icelandic: Upplýsa skal sjúklinginn um að aukaverkanir eins og svimi eða þokusýn geta gert vart við sig meðan á meðferð með dasatinibi stendur.
English: Rates of MMR were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Icelandic: Tíðni MMR var markvisst hærri hjá sjúklingum sem fengu meðferð með dasatinib samanborið við sjúklinga sem fengu meðferð með imatinib.
English: SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
Icelandic: SPRYCEL 80 mg filmuhúðaðar töflur EU/1/06/363/013
English: Haematologic response rateb (%) MaHR (95% CI)
Icelandic: Blóðsvörunb (%) MaHR (95% CI)
English: The powder for oral suspension consists of powder blend with the active substance plus excipients, contained within a bottle for constitution.
Icelandic: Mixtúruduft, dreifa samanstendur af duftblöndu með virka efninu ásamt hjálparefnum í glasi til blöndunar.
English: The other ingredients are: Tablet core: lactose monohydrate (see section 2 "SPRYCEL contains lactose"); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide (E171); macrogol 400
Icelandic: Töflukjarni: mjólkursykureinhýdrat (sjá kafla 2 ,,SPRYCEL inniheldur mjólkursykur“), örkristallaður sellulósi, croscaramellos natríum, hýdroxýprópýlsellulósi, magnesíumsterat Filmuhúð: hýprómellósa, títantvíoxíð, makrógól 400
English: Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
Icelandic: Mjög algengar mergbæling (þ.m.t. blóðleysi, daufkyrningafæð, blóðflagnafæð)
English: Patients should be tested for HBV infection before initiating treatment with SPRYCEL.
Icelandic: B veirusýkingu áður en meðferð með SPRYCEL er hafin.
English: oral syringe bottle
Icelandic: munngjafarsprauta glas
English: Persons other than the patient should use gloves when handling SPRYCEL.
Icelandic: Sérstakar leiðbeiningar um meðhöndlun SPRYCEL Öðrum en sjúklingnum er ráðlagt að nota hanska þegar SPRYCEL er handleikið.
English: Following resolution of the first episode, reintroduction of dasatinib at the same dose level should be considered.
Icelandic: Þegar búið er að yfirvinna aukaverkun sem kemur fram í fyrstu meðferðarlotu skal íhuga að hefja meðferð að nýju með sama skammti af dasatinibi.
English: SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
Icelandic: SPRYCEL 140 mg filmuhúðaðar töflur EU/1/06/363/015
English: Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflammation of the skin, persistent noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, bruise, depression, insomnia, flushing, dizziness, contusion (bruising), anorexia, somnolence, generalised oedema Pain: pain in joints, muscular weakness, chest pain, pain around hands and feet, chills, stiffness in muscles and joints, muscle spasm
Icelandic: Húð, hár, augu, almennar aukaverkanir: náladofi, kláði, húðþurrkur, þrymlabólur, bólga í húð, viðvarandi hávaði í eyrum, hármissir, mikil svitamyndun, sjónvandamál (m.a. þokusýn, sjóntruflanir), augnþurrkur, mar, þunglyndi, svefnleysi, hitakóf, sundl, mar, lystarleysi, svefndrungi, almennur bjúgur
English: ≤ 100,000/mm3.
Icelandic: 60 mg/m2.
English: White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
Icelandic: Hvít til beinhvít, tvíkúpt, kringlótt filmuhúðuð tafla með „BMS 140“ greypt í aðra hliðina og „857“ í hina.