FrancophonIA/ELRC3.0 huggingface dataset:
English: • phenobarbital, phenytoin: medicines to treat epilepsy.
Slovenian: • fenobarbital, fenitoin: zdravili za zdravljenje epilepsije
English: Fatal and serious heart failure or left ventricular dysfunction occurred in Iclusig-treated patients, including events related to prior vascular occlusive events.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, se je pojavilo smrtno in resno srčno popuščanje ali disfunkcija levega prekata, vključno z dogodki, povezanimi s predhodnimi vaskularnimi okluzivnimi dogodki.
English: • increased blood level of bilirubin - the yellow breakdown substance of the blood pigment
Slovenian: • zvišana raven bilirubina (rumene razgradne snovi krvnega pigmenta) v krvi
English: Poly(vinyl alcohol) Titanium dioxide (E171)
Slovenian: Obloga tablete smukec makrogol 4000 polivinilalkohol titanov dioksid (E171)
English: • fatigue, accumulation of fluid in arms and/or legs, fever, pain
Slovenian: • utrujenost, kopičenje tekočine v rokah in/ali nogah, zvišana telesna temperatura, bolečine
English: Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone.
Slovenian: Sočasna uporaba enega 15 mg peroralnega odmerka zdravila Iclusig v prisotnosti ketokonazola (400 mg na dan), močnega zaviralca CYP3A, je povzročila blago zvišanje sistemske izpostavljenosti ponatinibu, z vrednostma AUC0-∞ in Cmax, ki sta bili za 78 % oz. 47 % višji kot pri dajanju samega ponatiniba.
English: The frequency of these events is greater in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML).
Slovenian: Pogostnost teh dogodkov je večja pri bolnikih s KLM v pospešeni fazi (AP-KML) ali KLM v blastni fazi (BP-KML)/Ph+ ALL, kot pri bolnikih s KML v kronični fazi (CP-KML).
English: • a 45 mg film-coated tablet for the recommended dose.
Slovenian: • 45 mg filmsko obložene tablete za priporočeni odmerek,
English: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
Slovenian: • s kronično mieloidno levkemijo (KML) v kronični fazi, pospešeni fazi ali blastni fazi, ki so odporni na dasatinib ali nilotinib; ki ne prenašajo dasatiniba ali nilotiniba in pri katerih nadaljnje zdravljenje z imatinibom ni klinčno ustrezno; ali ki imajo mutacijo T315I
English: • fluid in the thorax (may cause breathing difficulty), nosebleed, difficulty producing voice sounds,
Slovenian: • tekočina v prsnem košu (lahko povzroči težave z dihanjem), krvavitev iz nosu, težave pri proizvajanju glasov, hipertenzija v pljučih
English: • upper airway infection
Slovenian: • okužba zgornjih dihal
English: The secondary efficacy endpoints in CPCML were complete haematological response (CHR) and major molecular response (MMR).
Slovenian: Sekundarni opazovani dogodek učinkovitosti pri bolnikih s CP-KML je bil celovit hematološki odgovor (CHR, complete haematological response) in bistven molekularni odgovor (MMR, major molecular response).
English: Ponatinib elicited tumour shrinkage and prolonged survival in mice bearing tumours expressing native or T315I mutant BCR-ABL.
Slovenian: Ponatinib je povzročil krčenje tumorja in podaljšano preživetje pri miših s tumorji, ki so izražali nativen BCR-ABL ali BCR-ABL z mutacijo T315I.
English: • heart failure (symptoms include: weakness, fatigue, swollen legs)
Slovenian: • srčno popuščanje (simptomi vključujejo: šibkost, utrujenost, otekanje nog)
English: A benefit-risk consideration should guide a decision to restart Iclusig therapy (see sections 4.4 and 4.8) after the event is resolved.
Slovenian: Pri odločitvi o ponovni uvedbi zdravljenja z zdravilom Iclusig je treba upoštevati oceno koristi in tveganj (glejte poglavji 4.4 in 4.8), ko se dogodek razreši.
English: Monitoring for evidence of thromboembolism and vascular occlusion should be performed and Iclusig should be interrupted immediately in case of vascular occlusion.
Slovenian: Spremljati je treba znake trombembolije in žilne okluzije in zdravljenje z zdravilom Iclusig takoj prekiniti, če se pojavi žilna okluzija.
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation.
Slovenian: • sulfasalazin: zdravilo za zdravljenje hudega vnetja črevesja ali revmatičnega vnetja sklepov
English: Vascular occlusive adverse events were more frequent with increasing age and in patients with prior history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Slovenian: Neželeni dogodki žilne okluzije so bili pogostejši pri starejših bolnikih in pri bolnikih z ishemijo, hipertenzijo, sladkorno boleznijo ali hiperlipidemijo v anamnezi.
English: approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Slovenian: Po enkratnem peroralnem odmerku s [14C] označenega ponatiniba se je približno 87 % radioativnega odmerka pojavilo v blatu in približno 5 % v urinu.
English: The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BP-CML/Ph+ ALL than in patients with CP-CML (see Table 4).
Slovenian: Pogostnost trombocitopenije, nevtropenije in anemije 3. ali 4. stopnje je bila pogostejša pri bolnikih z AP-KML in BP-KML/Ph+ ALL, kot pri bolnikih s CP-KML (glejte preglednico 4).
English: In the phase 2 trial, serious arterial and venous occlusive adverse reactions occurred in 18% of patients (treatment-emergent frequencies).
Slovenian: V preskušanjih 2. faze so se resni arterijski in venski okluzivni neželeni učinki pojavili pri 18 % bolnikov (pogostnosti v povezavi z zdravljenjem).
English: The trial enrolled 449 patients of which 444 were eligible for analysis: 267 CP-CML patients (R/I Cohort: n=203, T315I Cohort: n=64), 83 AP-CML patients (R/I Cohort: n=65, T315I Cohort: n=18), 62 BP-CML (R/I Cohort: n=38, T315I Cohort: n=24) and 32 Ph+ ALL patients (R/I Cohort: n=10, T315I Cohort: n=22).
Slovenian: V preskušanje je bilo vključenih 449 bolnikov, med katerimi jih je bilo 444 primernih za analizo: 267 bolnikov s CP-KML (kohorta O/N: n = 203, kohorta T315I: n = 64), 83 bolnikov z AP-KML
English: Table 7 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Slovenian: Preglednica 7 Učinkovitost zdravila Iclusig pri bolnikih s KML z napredovalo fazo, ki so na zdravljenje odporni ali ga ne prenašajo KML v pospešeni fazi
English: Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 6.7%, 5.6%, and 5.1% of Iclusig treated patients, respectively.
Slovenian: Resni arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni dogodki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 6,7 %, 5,6 % oz. 5,1 % bolnikov, zdravljenih z zdravilom Iclusig.
English: Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatment-emergent frequencies) occurred in 9.6%, 7.3%, and 6.9% of Iclusig-treated patients, respectively.
Slovenian: Arterijski kardiovaskularni, cerebrovaskularni in periferni vaskularni okluzivni neželeni dogodki (pogostnosti v povezavi z zdravljenjem) so se pojavili pri 9,6 %, 7,3 % oz. 6,9 % bolnikov, zdravljenih z zdravilom Iclusig.
English: What Iclusig looks like and contents of the pack
Slovenian: Izgled zdravila Iclusig in vsebina pakiranja
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median duration of MaHR for AP-CML (median duration of treatment: 590 days) BP-CML (median duration of treatment: 89 days), and Ph+ ALL (median duration of treatment: 81 days) patients was estimated as 13.1 months (range: 1.2 to 35.8+ months), 6.1 months (range: 1.8 to 31.8+ months), and 3.3 months (range: 1.8 to 13.0 months), respectively.
Slovenian: V času posodobljenega poročanja z minimalnim spremljanjem za vse trenutne bolnike 27 mesecev je bila mediana trajanja MaHR za bolnike z AP-KML (mediana trajanja zdravljenja: 590 dni) ocenjena na 13,1 meseca (razpon: 1,2 do 35,8+ mesecev), za bolnike z BP-KML (mediana trajanja zdravljenja: 89 dni) na 6,1 meseca (razpon: 1,8 do 31,8+ mesecev) in za bolnike s Ph+ ALL (mediana trajanja zdravljenja: 81 dni) na 3,3 meseca (razpon: 1,8 do 13,0 mesecev).
English: • ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections.
Slovenian: • ketokonazol, itrakonazol, vorikonazol: zdravila za zdravljenje glivičnih okužb
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/839/001
English: • skin rash, itching, peeling of the skin, redness, bruising, skin pain, hair loss
Slovenian: • kožni izpuščaj, srbenje, luščenje kože, rdečina kože, podplutost, boleča koža, izpadanje las
English: 6.6 Special precautions for disposal and other handling Disposal:
Slovenian: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Odstranjevanje:
English: Gender, race and body weight were not predictive in explaining ponatinib pharmacokinetic intersubject variability.
Slovenian: S pomočjo spola, rase in telesne mase ni mogoče napovedati razlik v farmakokinetiki ponatiniba pri posameznikih.
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Slovenian: • z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph+ ALL), ki so odporni na dasatinib in pri katerih nadaljnje zdravljenje z imatinibom ni klinčno ustrezno; ali ki imajo mutacijo T315I.
English: • blurred vision, dry eye
Slovenian: • zamegljen vid, suhe oči
English: Unchanged ponatinib accounted for 24% and <1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Slovenian: V blatu je bilo 24 % nespremenjenega uporabljenega ponatiniba in v urinu < 1 %, preostali odmerek pa so predstavljali presnovki.
English: The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR).
Slovenian: Primarni opazovani dogodek učinkovitosti pri bolnikih s CP-CML je bil bistven citogenetski odgovor (MCyR, major cytogenetic response), ki je vključeval celovit (CCyR, complete cytogenetic response) ali delni citogenetski odgovor (PCyR, partial cytogenetic response).
English: Ponatinib is not displaced by concomitant administration of ibuprofen, nifedipine, propranolol, salicylic acid, or warfarin.
Slovenian: Sočasna uporaba ibuprofena, nifedipina, propranolola, salicilne kisline ali varfarina ne izpodrine ponatiniba.
English: Substances that may decrease ponatinib serum concentrations
Slovenian: Snovi, ki lahko zmanjšajo koncentracijo ponatiniba v serumu
English: Isolated reports of unintentional overdose with Iclusig were reported in clinical trials.
Slovenian: Iz kliničnih preskušanj poročajo o izoliranih poročilih nenamernega prevelikega odmerjanja.
English: • The active substance is ponatinib.
Slovenian: • Zdravilna učinkovina je ponatinib.
English: What Iclusig contains
Slovenian: Kaj vsebuje zdravilo Iclusig
English: Periodic safety update reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: • colchicine: a medicine to treat gout attacks.
Slovenian: • kolhicin: zdravilo za zdravljenje napadov protina
English: • chills, flu-like illness
Slovenian: • mrzlica, gripi podobna bolezen
English: In the phase 2 trial, arterial and venous occlusive adverse reactions have occurred in 23% of patients (treatment-emergent frequencies).
Slovenian: V preskušanju 2. faze so se arterijski in venski okluzivni neželeni učinki pojavili pri 23 % bolnikov (pogostnosti v povezavi z zdravljenjem).
English: Substances that may increase ponatinib serum concentrations
Slovenian: Snovi, ki lahko povečajo koncentracijo ponatiniba v serumu
English: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, so se pojavili arterijska in venska tromboza in okluzija, vključno s smrtnim miokardnim infarktom, možgansko kapjo, stenozo velikih arterijskih žil v možganih, hudo periferno žilno boleznijo in potrebo po nujnem postopku revaskularizacije.
English: In rats, embryo-foetal toxicity in the form of post-implantation loss, reduced foetal body weight, and multiple soft tissue and skeletal alterations were observed at maternal toxic dosages.
Slovenian: Pri podganah so pri odmerkih, toksičnih za mater, opazili toksičnost za zarodek/plod v obliki izgube po ugnezditvi, zmanjšane telesne mase plodov in številnih sprememb mehkega tkiva in okostja.
English: Talk to your doctor or pharmacist before taking Iclusig if you have:
Slovenian: Pred začetkom jemanja zdravila Iclusig se posvetujte s svojim zdravnikom ali farmacevtom, če imate:
English: • pain in bones, joints, back, arms or legs, muscle spasms
Slovenian: • bolečine v kosteh, sklepih, hrbtu, rokah ali nogah, mišični krči
English: Do not swallow the desiccant canister contained in the bottle.
Slovenian: Ne pogoltnite posode s sušilnim sredstvom, ki je v plastenki.
English: • Consider discontinuing Iclusig
Slovenian: • Razmislite o ukinitvi zdravljenja z zdravilom Iclusig
English: • had a prior heart attack or stroke
Slovenian: • predhodni srčni napad ali možgansko kap
English: In cellular assays, ponatinib was able to overcome imatinib, dasatinib, and nilotinib resistance mediated by BCR-ABL kinase domain mutations.
Slovenian: V celičnih testih je ponatinib premagal odpornost na imatinib, dasatinib in nilotinib, pri kateri posredujejo mutacije domene kinaze BCR-ABL.
English: Consider discontinuation of ponatinib in patients who develop serious heart failure (see sections 4.2 and 4.8).
Slovenian: Pri bolnikih, pri katerih se razvije resno srčno popuščanje, je treba razmisliti o ukinitvi ponatiniba (glejte poglavji 4.2 in 4.8).
English: In cynomolgus monkeys, systolic heart murmurs with no macroscopic or microscopic correlates were noted in individual animals treated with 5 and 45 mg/kg in the single dose toxicity study and at 1, 2.5 and 5 mg/kg in the 4-week repeat-dose toxicity study.
Slovenian: V opicah cynomolgus so pri posameznih živalih, ki so dobivale 5 in 45 mg/kg v študiji toksičnosti pri enkratnem odmerku in 1, 2,5 in 5 mg/kg v 4-tedenski študiji toksičnosti pri ponavljajočih se odmerkih opazili sistolični šum na srcu brez makroskopskih ali mikroskopskih korelatov.
English: No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics.
Slovenian: Intrinzični dejavniki, ki vplivajo na farmakokinetiko ponatiniba Specifičnih študij za ocenitev vpliva spola, starosti, rase in telesne mase na farmakokinetiko ponatiniba niso opravili.
English: Very common side effects (affects more than 1 per 10 users):
Slovenian: Zelo pogosti neželeni učinki (prizadenejo več kot 1 od 10 bolnikov):
English: Iclusig 45 mg film-coated tablets are approximately 9 mm in diameter with "AP4" on one side.
Slovenian: Zdravilo Iclusig 45 mg filmsko obložene tablete imajo v premeru približno 9 mm in vtisnjeno oznako "AP4" na eni strani.
English: Depletion of lymphoid organs was observed in repeat-dose toxicity studies in rats and cynomolgus monkeys.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih so pri podganah in opicah cynomolgus opazili izginjanje limfatičnih organov.
English: *Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Slovenian: *Poročilo v skladu s Poenotenimi kriteriji za neželene učinke Nacionalnega inštituta za raka, različica
English: Dry flaky skin was observed in toxicity studies in rats.
Slovenian: V študijah toksičnosti pri podganah so opazili suho luskavo kožo.
English: Iclusig 15 mg film-coated tablets are approximately 6 mm in diameter with "A5" on one side.
Slovenian: Zdravilo Iclusig 15 mg filmsko obložene tablete imajo v premeru približno 6 mm in vtisnjeno oznako "A5" na eni strani.
English: Table 8 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Slovenian: Preglednica 8 Učinkovitost zdravila Iclusig pri bolnikih Ph+ ALL, ki so na zdravljenje odporni ali ga ne prenašajo
English: • indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection.
Slovenian: • indinavir, nelfinavir, ritonavir, sakvinavir: zdravila za zdravljenje okužbe z virusom HIV
English: Caution is recommended when administering Iclusig to patients with severe hepatic impairment (see section 5.2).
Slovenian: Pri dajanju zdravila Iclusig bolnikom s hudo okvaro jeter se priporoča previdnost (glejte poglavje 5.2).
English: Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triplebond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.
Slovenian: Ponatinib je močan zaviralec pan-BCR-ABL s strukturnimi elementi, vključno s trojno vezjo ogljik-ogljik, ki omogočajo visoko afiniteto vezave na nativni BCR-ABL in mutirane oblike kinaze ABL. Ponatinib zavira aktivnost tirozin-kinaze ABL in mutanta ABL T315I z vrednostmi IC50 0,4 oz. 2,0 nM.
English: Method of use
Slovenian: Način uporabe
English: The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients who received 30 mg, 45 mg, or 60 mg Iclusig once daily.
Slovenian: Potencial zdravila Iclusig za podaljšanje intervala QT so ocenili pri 39 bolnikih z levkemijo, ki so prejemali 30 mg, 45 mg ali 60 mg zdravila Iclusig enkrat na dan. Za ovrednotenje učinka ponatiniba na interval QT so opravili po tri zaporedne EKG-meritve ob izhodišču in v stanju dinamičnega ravnovesja.
English: Calcium decreased
Slovenian: Znižana raven kalcija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/839/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/839/003
English: Iclusig 15 mg film-coated tablets Iclusig 45 mg film-coated tablets
Slovenian: Iclusig 15 mg filmsko obložene tablete Iclusig 45 mg filmsko obložene tablete ponatinib
English: What you need to know before you take Iclusig
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Iclusig Ne jemljite zdravila Iclusig
English: The bottle contains one sealed plastic canister containing molecular sieve desiccant.
Slovenian: Plastenka vsebuje eno zaprto plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with "AP4" debossed on one side.
Slovenian: Bela, bikonveksna, okrogla filmsko obložena tableta s približno 9 mm premera, z vtisnjeno oznako "AP4" na eni strani.
English: Continue Iclusig at the same dose
Slovenian: Nadaljujte z enakim odmerkom zdravila Iclusig
English: • increased blood levels of liver and pancreatic enzymes:
Slovenian: • zvišane ravni jetrnih encimov in encimov trebušne slinavke v krvi:
English: The primary efficacy endpoint in AP-CML and BP-CML/Ph+ ALL was major haematological response (MaHR), defined as either a complete haematological response (CHR) or no evidence of leukaemia (NEL).
Slovenian: Primarni opazovani dogodek učinkovitosti pri bolnikih z AP-KML in BP-KML/Ph+ ALL je bil bistven hematološki odgovor (MaHR, major haematological response), opredeljen kot bodisi celovit hematološki odgovor (CHR, complete haematological response) ali odsotnost dokazov o levkemiji (NEL, no evidence of leukaemia).
English: • fluid retention
Slovenian: • zastajanje tekočine
English: White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side.
Slovenian: Bela, bikonveksna, okrogla filmsko obložena tableta s približno 6 mm premera, z vtisnjeno oznako "A5" na eni strani.
English: A benefit -risk consideration should guide a decision to restart Iclusig therapy (see sections 4.2 and 4.8).
Slovenian: Pri odločitvi o ponovni uvedbi zdravljenja z zdravilom Iclusig je treba upoštevati oceno koristi in tveganj (glejte poglavji 4.2 in 4.8).
English: Iclusig may be administered with or without food.
Slovenian: Zdravilo Iclusig se lahko daje s hrano ali brez nje.
English: In cynomolgus monkeys, thyroid gland follicular atrophy mostly accompanied by a reduction in T3 levels and a tendency toward increased TSH levels were observed in the 4-week repeat-dose toxicity study in cynomolgus monkeys.
Slovenian: Pri opicah cynomolgus so v 4-tedenski študiji toksičnosti s ponavljajočimi se odmerki na opicah cynomolgus opazili atrofijo folikularnih celic ščitnice, ki jo je spremljalo znižanje ravni T3 in tendenca k zvišanju ravni TSH.
English: Liver function abnormality
Slovenian: Nenormalnosti delovanja jeter
English: Very common insomnia
Slovenian: Psihiatrične motnje zelo pogosti nespečnost
English: Venous occlusive reactions (treatment-emergent frequencies) occurred in 5.0% of patients.
Slovenian: Venske okluzivne reakcije (pogostnosti v povezavi z zdravljenjem) so se pojavile pri 5,0 % bolnikov.
English: Serious side effects (common: affects 1 to 10 users in 100):
Slovenian: Resni neželeni učinki (pogosti: prizadenejo 1 do 10 od 100 bolnikov):
English: Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack
Slovenian: Bolezni živčevja zelo pogosti glavobol, omotica pogosti cerebrovaskularni dogodek, cerebralni infarkt, periferna nevropatija, letargija, migrena, hiperestezija, hipoestezija, parestezija, prehodni ishemični napad občasni cerebralna arterijska stenoza
English: Keep the canister in the bottle.
Slovenian: Posodo shranjujte v plastenki.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte zdravnikova ali farmacevtova navodila.
English: Duration of use
Slovenian: Trajanje zdravljenja
English: Phosphorus decreased
Slovenian: Znižana raven fosforja
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients (see section 4.8).
Slovenian: Resne venske okluzivne reakcije (pogostnosti v povezavi z zdravljenjem) so se pojavile pri 4,5 % bolnikov (glejte poglavje
English: With once daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose andsteady state conditions.
Slovenian: Z odmerjanjem enkrat na dan se je med prvim odmerkom in stanjem dinamičnega ravnovesja plazemska izpostavljenost ponatinibu povečala za približno 1,5-krat.
English: Multiple foetal soft tissue and skeletal alterations were also observed at maternal nontoxic dosages.
Slovenian: Tudi pri odmerkih, ki za mater niso bili toksični, so opazili številne spremembe mehkega tkiva in okostja pri plodovih.
English: Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath.
Slovenian: Za hipertenzijo, povezano z zmedenostjo, glavobolom, bolečinami v prsih ali zasoplostjo, bo morda potrebna nujna klinična intervencija.
English: Leukopenia (WBC decreased)
Slovenian: Levkopenija (zmanjšanje števila levkocitov)
English: Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients.
Slovenian: Resne venske okluzivne reakcije (pogostnosti v povezavi z zdravljenjem) so se pojavile pri 4,5 % bolnikov.