FrancophonIA/ELRC3.0 huggingface dataset:
English: After a minimum of 60 months follow-up, the cumulative rates of neutropaenia, thrombocytopaenia, and anaemia were 29%, 22% and 13%, respectively.
Slovenian: Po najmanj 60-mesečnem obdobju spremljanja je kumulativni delež nevtropenije znašal 29%, kumulativni delež trombocitopenije 22%, kumulativni delež anemije pa 13%.
English: Tests may show: abnormal blood test results and possibly impaired kidney function caused by the waste products of the dying tumour (tumour lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell) in the blood, high level of cholesterol in the blood, swollen lymph nodes, bleeding in the brain, irregularity of the electrical activity of the heart, enlarged heart, inflammation of the liver, protein in the urine, raised creatine phosphokinase (an enzyme mainly found in the heart, brain and skeletal muscles), raised troponin (an enzyme mainly found in the heart and skeletal muscles), raised gamma-glutamyltransferase (an enzyme mainly found in the liver)
Slovenian: Preiskave lahko pokažejo: nenormalne rezultate krvnih preiskav, lahko pa tudi okvaro delovanja ledvic zaradi odpadnih produktov odmirajočega tumorja (sindrom tumorske lize), nizko vrednost albumina v krvi, zmanjšanje števila limfocitov (vrsta belih krvnih celic) v krvi, visoko vrednost holesterola v krvi, otekle bezgavke, krvavitev v možganih, nepravilno električno aktivnost srca, povečanje srca, vnetje jeter, beljakovine v urinu in zvišano vrednost kreatin-fosfokinaze (encim, ki se pretežno nahaja v srcu, možganih in skeletnih mišicah), zvišano vrednost troponina (encim, ki se pretežno nahaja v srčni in skeletni mišičnini) in zvišano vrednost gama-glutamiltransferaze (encim, ki se pretežno nahaja v jetrih).
English: Infections and infestations Very common infection (including bacterial, viral, fungal, non-specified)
Slovenian: Zelo pogosti okužbe (vključno z bakterijskimi, virusnimi, glivičnimi in nespecifičnimi okužbami)
English: In clinical studies, treatment with SPRYCEL in adults with Ph+ CML-CP, accelerated, myeloid or lymphoid blast phase (advanced phase) CML, or Ph+ ALL and paediatric patients with Ph+ CML-CP was continued until disease progression or until no longer tolerated by the patient.
Slovenian: V kliničnih študijah je zdravljenje z zdravilom SPRYCEL pri odraslih bolnikih s Ph+ KML-KO, s KML v obdobju pospešenega poteka, obdobju mieloblastne ali limfoblastne preobrazbe (napredovalo obdobje), ali s Ph+ ALL in pediatričnih bolnikih s Ph+ KML-KO trajalo, dokler bolezen ni napredovala oziroma dokler je bolnik zdravljenje prenašal.
English: b Includes ventricular dysfunction, cardiac failure, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and ventricular failure.
Slovenian: b Vključuje ventrikularno disfunkcijo, srčno popuščanje, kongestivno srčno popuščanje, kardiomiopatijo, kongestivno kardiomiopatijo, diastolno disfunkcijo, zmanjšanje iztisnega deleža in ventrikularno popuščanje.
English: MEDIAN (95% CI)
Slovenian: MEDIANA (95% IZ)
English: The recommended starting dose for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL is 140 mg once daily (see section 4.4).
Slovenian: Priporočeni začetni odmerek za zdravljenje KML v obdobju pospešenega poteka in obdobju mieloblastne ali limfoblastne preobrazbe (napredovalo obdobje) ali zdravljenje Ph+ ALL je 140 mg enkrat na dan (glejte poglavje 4.4).
English: After constitution, one bottle contains 99 mL of oral suspension.
Slovenian: Po rekonstituciji, ena plastenka vsebuje 99 ml peroralne suspenzije.
English: Excipients: contains lactose monohydrate.
Slovenian: Pomožne snovi: vsebuje laktozo monohidrat.
English: Not known atrial fibrillation/atrial flutter Vascular disorders
Slovenian: Neznana pogostnost atrijska fibrilacija/atrijsko plapolanje
English: Histamine-2 antagonists and proton pump inhibitors
Slovenian: Antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke
English: c Major molecular response (at any time) was defined as BCR ABL ratios ≤ 0.1% by RQ PCR in peripheral blood samples standardised on the International scale.
Slovenian: c Dober molekularni odziv (ob katerem koli času) je bil opredeljen kot razmerje BCR ABL ≤ 0,1% z RQ PCR v vzorcu periferne krvi, standardiziranem po mednarodni lestvici.
English: SPRYCEL should not be taken with grapefruit or grapefruit juice (see section 4.5).
Slovenian: Zdravila SPRYCEL se ne sme jemati skupaj z grenivko ali s sokom grenivke (glejte poglavje 4.5).
English: Very common skin rashe Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria, hyperhidrosis
Slovenian: Pogosti alopecija, dermatitis (vključno z ekcemom), pruritus, akne, suha koža, urtikarija, čezmerno znojenje
English: No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration > 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Slovenian: Pri bolnikih z zmanjšanim delovanjem ledvic klinične študije z zdravilom SPRYCEL niso bile izvedene (študija, izvedena pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju, ni vključevala bolnikov, ki so imeli koncentracijo kreatinina v serumu > 3-krat večjo od zgornje meje referenčne vrednosti, študije, izvedene pri bolnikih s KML v kroničnem obdobju, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali, pa niso vključevale bolnikov, ki so imeli koncentracijo kreatinina v serumu > 1,5-krat večjo od zgornje meje referenčne vrednosti).
English: Additionally, in vitro and in vivo platelet assays suggest that SPRYCEL treatment reversibly affects platelet activation.
Slovenian: Razen tega pa in vitro ter in vivo testi funkcije trombocitov kažejo, da ima zdravljenje z zdravilom SPRYCEL tudi reverzibilen vpliv na aktivacijo trombocitov.
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.
Slovenian: Pri bolnikih, ki so se pred vključitvijo v študijo zdravili z imatinibom v odmerku 400 mg, je bil v skupini, ki je prejemala dasatinib dober citogenetski odziv dosežen pri 61% bolnikov, v skupini, ki je prejemala imatinib, pa pri 50% bolnikov.
English: Figure 2: MMR rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
Slovenian: Slika 2: Deleži MMR glede na čas - vsi randomizirani bolniki v študiji 3. faze, izvedeni pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju
English: If a severe grade 3 or 4, non-haematologic adverse reaction develops with dasatinib, treatment must be withheld until the adverse reaction has resolved.
Slovenian: Če se med zdravljenjem z dasatinibom pojavi resen nehematološki neželeni učinek (stopnje 3 ali 4), je treba zdravljenje prekiniti, dokler neželeni učinek ne mine.
English: Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM.
Slovenian: Dasatinib je močan subnanomolaren zaviralec BCR-ABL kinaze, učinkovit pri koncentraciji od 0,6 do 0,8 nM. Dasatinib se veže tako na neaktivno kot na aktivno konformacijo encima BCR-ABL.
English: The other ingredients are: sucrose, carmellose sodium, simethicone emulsion (consisting of simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid), tartaric acid, trisodium citrate anhydrous, sodium benzoate (E211), silica hydrophobic colloidal, mixed berry flavour (containing: benzyl alcohol, sulphur dioxide) (see section 2 "What you need to know before you take SPRYCEL").
Slovenian: Druge sestavine zdravila so: saharoza, natrijev karmelozat, emulzija simetikona (sestavljena iz simetikona, polietilenglikol sorbitan tristearata, polietoksilat stearata, gliceridov, metilceluloze, ksantanskega gumija, benzojske kisline, sorbinske kisline, žveplove kisline), vinska kislina, brezvodni trinatrijev citrat, natrijev benzoat (E211), koloidni hidrofobni silicijev dioksid, aroma mešanega jagodičevja (vsebuje benzilalkohol, žveplov dioksid).
English: SPRYCEL 20 mg, SPRYCEL 50 mg and SPRYCEL 70 mg film-coated tablets Alu/Alu blisters (calendar blisters or perforated unit dose blisters).
Slovenian: SPRYCEL 20 mg, SPRYCEL 50 mg in SPRYCEL 70 mg filmsko obložene tablete Alu/alu pretisni omoti (koledarski pretisni omoti ali perforirani enoodmerni pretisni omoti).
English: n/a = not applicable; CI = confidence interval; ULN = upper limit of normal range.
Slovenian: n/a = ni pomembno; IZ = interval zaupanja
English: 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.
Slovenian: Po 60 mesecih spremljanja je pri bolnikih s potrjenim CCyR mediana vrednost časa do cCCyR v skupini, ki je prejemala zdravilo SPRYCEL znašala 3,1 meseca, v skupini, ki je prejemala imatinib pa 5,8 meseca.
English: SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each, and in cartons containing 60 x 1 film-coated tablets in perforated unit dose blisters.
Slovenian: Zdravilo SPRYCEL 20 mg, 50 mg ali 70 mg filmsko obložene tablete je na voljo v škatlah s 56 filmsko obloženimi tabletami v 4 koledarsko označenih pretisnih omotih (en pretisni omot vsebuje 14 tablet) in v škatlah s 60 x 1 filmsko obloženo tableto v perforiranih, enoodmernih pretisnih omotih.
English: Total prescribed dose (mL)
Slovenian: Skupni predpisani odmerek (ml)
English: Both men and women taking SPRYCEL will be advised to use effective contraception during treatment.
Slovenian: Med zdravljenjem z zdravilom SPRYCEL morajo tako moški kot ženske uporabljati učinkovito metodo kontracepcije.
English: The starting dose recommended for adult patients with accelerated or blast crisis CML or Ph+ ALL is 140 mg once a day.
Slovenian: Priporočeni začetni odmerek za odrasle bolnike s KML v obdobju pospešenega poteka ali blastne krize in pri bolnikih s Ph+ ALL je 140 mg enkrat na dan.
English: Laboratory test abnormalities Haematology
Slovenian: Odstopanja od normalnih vrednosti laboratorijskih preiskav Hematologija
English: Temporary dose reductions for intermediate degrees of cytopaenia and disease response should be implemented as needed.
Slovenian: Pri zmernih stopnjah citopenije in odzivnosti bolezni je treba odmerke po potrebi začasno zmanjšati.
English: The median changes in QTcF from baseline were 3.0 msec in dasatinib-treated patients compared to 8.2 msec in imatinib-treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z dasatinibom, je srednja vrednost spremembe vrednosti QTcF od izhodišča znašala 3,0 milisekunde, pri bolnikih, ki so se zdravili z imatinibom, pa 8,2 milisekund.
English: Powder: Store below 25°C.
Slovenian: Prašek: Shranjujte pri temperaturi do 25 °C.
English: In adult patients with advanced phase CML or Ph+ ALL treated with dasatinib as monotherapy, complete blood counts (CBCs) should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated.
Slovenian: Pri odraslih bolnikih s KML v napredovalem obdobju ali s Ph+ ALL, ki se z dasatinibom zdravijo v monoterapiji, je preiskavo celotne krvne slike prva 2 meseca zdravljenja treba izvajati enkrat na teden, nato pa enkrat na mesec, oziroma kot je to klinično indicirano.
English: Rare side effects (may affect up to 1 in 1,000 people) Heart and lungs: enlargement of the right ventricle in the heart, inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) Srce in pljuča: povečanje desnega srčnega prekata, vnetje srčne mišice, skupek stanj, ki so posledica ovirane oskrbe srčne mišice s krvjo (akutni koronarni sindrom), srčni zastoj (prekinitev iztoka krvi iz srca), bolezen koronarnih (srčnih) arterij, vnetje tkiva, ki obdaja srce in pljuča, krvni strdki in krvni strdki v pljučih.
English: The once daily schedule demonstrated comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MaHR 0.8%; 95% confidence interval [-7.1% - 8.7%]); however, the 140 mg once daily regimen demonstrated improved safety and tolerability.
Slovenian: Pri primarnem opazovanem dogodku učinkovitosti se je izkazalo, da je učinkovitost režima zdravljenja enkrat na dan primerljiva (enakovredna) z režimom zdravljenja dvakrat na dan (razlika v dobrem hematološkem odzivu 0,8%; 95% interval zaupanja [-7,1% - 8,7%]), vendar pa je bil režim odmerjanja 140 mg enkrat na dan povezan z boljšo varnostjo in prenašanjem.
English: • 20 mg daily for patients taking SPRYCEL 100 mg tablet daily.
Slovenian: • 20 mg na dan pri bolnikih, ki jemljejo zdravilo SPRYCEL 100 mg tableto na dan.
English: There was no difference in OS (HR 1.01, 95% CI: 0.58-1.73, p= 0.9800) and PFS (HR 1.00, 95% CI: 0.58-1.72, p = 0.9998) between dasatinib and imatinib.
Slovenian: Pri celokupnem preživetju (razmerje ogroženosti 1,01; 95% IZ: 0,58-1,73; p= 0,9800) in preživetju brez napredovanja bolezni (razmerje ogroženosti 1,00; 95% IZ: 0,58-1,72; p = 0,9998) med dasatinibom in imatinibom ni bilo razlike.
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
Slovenian: Reakcijo z zvišano telesno temperaturo in pojavom mehurjev na koži ter razjed na sluznicah Bolezen ledvic s simptomi, ki vključujejo otekline in nenormalne rezultate laboratorijskih preiskav, kot so prisotnost beljakovin v urinu in znižane vrednosti beljakovin v krvi Poškodbe krvnih žil imenovane trombotična mikroangiopatija (TMA), vključno z zmanjšanim številom rdečih krvnih celic, trombocitov in nastankom krvnih strdkov.
English: Chronic phase CML - Newly diagnosed
Slovenian: KML v kroničnem obdobju - bolniki z na novo diagnosticirano boleznijo
English: Discontinuation within 60 months due to disease progression occurred in 11% of SPRYCEL-treated patients and 14% of imatinib-treated patients.
Slovenian: Zaradi napredovanja bolezni je bilo v 60 mesecih izključenih 11% bolnikov, ki so se zdravili z zdravilom SPRYCEL in 14% bolnikov, ki so se zdravili z imatinibom.
English: There is no experience with SPRYCEL treatment in children under 1 year of age.
Slovenian: Pri otrocih, mlajših od 1 leta, ni izkušenj z zdravljenjem z zdravilom SPRYCEL.
English: 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.
Slovenian: Po 60 mesecih spremljanja je pri bolnikih z MMR mediana vrednost časa do MMR v skupini, ki je prejemala zdravilo SPRYCEL, znašala 9,3 meseca, v skupini, ki je prejemala imatinib pa 15,0 meseca.
English: Myeloid blast phase (n= 74)c
Slovenian: Obdobje mieloblastne preobrazbe (n= 74)c
English: Patients should be advised that they may experience adverse reactions such as dizziness or blurred vision during treatment with dasatinib.
Slovenian: Bolnikom je treba pojasniti, da se med zdravljenjem z dasatinibom lahko pojavijo neželeni učinki, kot sta omotica in zamegljen vid, in da morajo biti zato pri vožnji in upravljanju strojev previdni.
English: A total of 387 patients received dasatinib 70 mg twice daily (288 resistant and 99 intolerant).
Slovenian: Dasatinib v odmerku 70 mg dvakrat na dan je skupaj prejemalo 387 bolnikov (288 rezistentnih in 99 intolerantnih).
English: Pericardial effusion Pulmonary oedema Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported at the recommended starting dose of 140 mg once daily (n=304) population at 2 year final study follow up.
Slovenian: Gastrointestinalne krvavitve a Rezultati študije 3. faze za določitev optimalnega odmerka pri uporabi priporočenega začetnega odmerka 140 mg enkrat na dan (n=304) po končanem 2-letnem obdobju spremljanja.
English: Cytogenetic responsec (%)
Slovenian: Citogenetski odzivc (%)
English: Brain: stroke, temporary episode of neurologic dysfunction caused by loss of blood flow, facial nerve paralysis, dementia
Slovenian: Možgani: možganska kap, prehodni nevrološki izpadi zaradi pomanjkljive prekrvavitve možganov, paraliza obraznega živca in demenca.
English: Contact your doctor immediately if you notice any of the above.
Slovenian: Če opazite kar koli od zgoraj navedenega, se nemudoma posvetujte z zdravnikom.
English: Cutaneous haemorrhage was observed in an acute, single-dose oral study in monkeys but was not observed in repeat-dose studies in either monkeys or rats.
Slovenian: Pri opicah so pri akutni študiji z enim peroralnim odmerkom opazili kožne krvavitve, vendar pa pri študijah s ponavljajočimi se odmerki kožnih krvavitev pri opicah ali podganah niso opazili.
English: Dasatinib was clastogenic in vitro to dividing Chinese Hamster Ovary (CHO) cells.
Slovenian: In vitro na delečih se ovarijskih celicah kitajskega hrčka je dasatinib deloval klastogeno.
English: Concomitant use of dexamethasone, a weak CYP3A4 inducer, with dasatinib is allowed; dasatinib AUC is predicted to decrease approximately 25% with concomitant use of dexamethasone, which is not likely to be clinically meaningful.
Slovenian: Pri sočasni uporabi deksametazona je pričakovati, da se bo vrednost AUC dasatiniba zmanjšala za približno 25%, za kar pa ni verjetno, da bi imelo klinični pomen.
English: In the 2,712 adult patients with either chronic phase CML, advanced phase CML or Ph+ ALL, the median duration of therapy was 19.2 months (range 0 to 93.2 months).
Slovenian: Pri 2.712 odraslih bolnikih s KML v kroničnem obdobju, KML v obdobju pospešenega poteka ali Ph+ ALL je mediana trajanja zdravljenja znašala 19,2 meseca (razpon 0 do 93,2 meseca).
English: SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablets in perforated unit dose blisters.
Slovenian: Zdravilo SPRYCEL 80 mg, 100 mg ali 140 mg filmsko obložene tablete je na voljo v škatlah s 30 x 1 filmsko obloženo tableto v perforiranih, enoodmernih pretisnih omotih.
English: Myeloid blast (n= 109)
Slovenian: Obdobje mieloblastne preobrazbe (n = 109)
English: Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Slovenian: Pri bolnikih, ki se zdravijo z dasatinibom, je torej v primeru sočasnega zdravljenja treba izbrati alternativna zdravila, pri katerih je tveganje za indukcijo CYP3A4 manjše (glejte poglavje 4.5).
English: In the newly diagnosed chronic phase CML study after a minimum of 60 months follow-up, dasatinib-related fluid retention adverse reactions included pleural effusion (28%), superficial oedema (14%), pulmonary hypertension (5%), generalised oedema (4%), and pericardial effusion (4%).
Slovenian: V študiji pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju so po najmanj 60-mesečnem obdobju spremljanja neželeni učinki zastajanja tekočin, povezani z uporabo dasatiniba, vključevali plevralni izliv (28%), površinski edem (14%), pljučno hipertenzijo (5%), generalizirani edem (4%) in perikardialni izliv (4%).
English: 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.
Slovenian: O največjem prevelikem odmerjanju (280 mg na dan v trajanju enega tedna) so poročali pri dveh bolnikih.
English: SPRYCEL film-coated tablets
Slovenian: SPRYCEL filmsko obložene tablete
English: The recommended starting daily dosage of SPRYCEL powder for oral suspension for paediatric patients with Ph+ CML-CP or Ph+ ALL and adult patients with Ph+ CML-CP who cannot swallow tablets is shown in Table 1.
Slovenian: Priporočeni začetni dnevni odmerek zdravila SPRYCEL prašek za peroralno suspenzijo za pediatrične bolnike s Ph+ KML-KO ali Ph+ ALL in odrasle bolnike s Ph+ KML-KO, ki ne morejo pogoltniti tablet, je prikazan v preglednici 1.
English: SPRYCEL is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age, and lymphoid blast CML in adults who are not benefiting from prior therapies.
Slovenian: Zdravilo SPRYCEL uporabljamo tudi za zdravljenje akutne limfoblastne levkemije (ALL) s prisotnostjo kromosoma Philadelphia (Ph+), pri odraslih, mladostnikih in otrocih, starih najmanj 1 leto ter KML v obdobju limfoblastne preobrazbe pri odraslih, pri katerih so bila predhodna zdravljenja neuspešna.
English: Carton containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each.
Slovenian: Škatla s 56 filmsko obloženimi tabletami v 4 koledarskih pretisnih omotih.
English: Holding the syringe tip firmly in the bottle, turn the bottle with the syringe upright again.
Slovenian: Konico brizge trdno držite v plastenki, plastenko pa obrnite tako, da bo brizga zopet zgoraj.
English: Uncommon blood creatine phosphokinase increased, gamma-glutamyltransferase increased Injury, poisoning, and procedural complications
Slovenian: Občasni zvišana vrednost kreatin-fosfokinaze v krvi, zvišana vrednost gama-glutamiltransferaze
English: With the bottle in an upright position, insert the tip of the syringe firmly into the bottle adapter.
Slovenian: S plastenko v pokončnem položaju konico brizge trdno pritrdite v nastavek v plastenki.
English: If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate o delovanju zdravila SPRYCEL kakršno koli vprašanje, ali če vas zanima, zakaj vam je bilo to zdravilo predpisano, se posvetujte z zdravnikom.
English: A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib).
Slovenian: Dasatinib v odmerku 70 mg dvakrat na dan je skupaj prejemalo 174 bolnikov (161 rezistentnih in 13 intolerantnih na imatinib).
English: Dasatinib did not affect male or female fertility in a conventional rat fertility and early embryonic development study, but induced embryolethality at dose levels approximating human clinical exposures.
Slovenian: V klasični študiji plodnosti in zgodnjega embrionalnega razvoja pri podganah dasatinib ni vplival na plodnost samcev ali samic, je pa povzročal smrtnost zarodkov pri odmerkih, ki so bili podobni izpostavljenosti pri človeku.
English: Therefore, caution is warranted when dasatinib is coadministered with CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine) (see section 4.5).
Slovenian: Pri bolnikih, ki se zdravijo z dasatinibom, je potrebna previdnost pri predpisovanju substratov za CYP3A4 z znano ozkim terapevtskim indeksom (npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil ali alkaloidi ergot [ergotamin, dihidroergotamin]) (glejte poglavje 4.4).
English: 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.
Slovenian: Bolnicam, ki so noseče ali bi lahko zanosile, je treba pojasniti možno tveganje za plod, povezano z dasatinibom, pa tudi s pomožno snovjo benzilalkoholom, ki se lahko sčasoma nakopiči in povzroči metabolično acidozo.