FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pups, decreased mean initial body weights and short period of decreased mean body weight gain were observed.
Slovenian: Pri mladičih so opažali manjšo povprečno telesno maso ob rojstvu in krajše obdobje zmanjšanega pridobivanja povprečne telesne mase.
English: Other side effects with Jakavi
Slovenian: Drugi neželeni učinki zdravila Jakavi
English: Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets ruxolitinib
Slovenian: Jakavi 5 mg tablete Jakavi 10 mg tablete Jakavi 15 mg tablete Jakavi 20 mg tablete ruksolitinib
English: In healthy subjects co-administration of ruxolitinib (10 mg single dose) with a dual CYP2C9 and CYP3A4 inhibitor, fluconazole, resulted in ruxolitinib Cmax and AUC that were higher by 47% and 232%, respectively, than with ruxolitinib alone.
Slovenian: Pri zdravih osebah je bila pri sočasnem odmerjanju ruksolitiniba (enkratnega odmerka 10 mg) skupaj z dvojnim zaviralcem CYP2C9 in CYP3A4, flukonazolom, Cmax ruksolitiniba za 47 % višja, AUC ruksolitiniba pa za 232 % večja kot pri odmerjanju samo ruksolitiniba.
English: Some are very common (may affect more than 1 in 10 people), some are common (may affect up to 1 in 10 people): - any sign of bleeding in the brain, such as sudden altered level of consciousness, persistent headache, numbness, tingling, weakness or paralysis (common) - any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood (common) - unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections (possible symptoms of blood disorders) (very common) - painful skin rash with blisters (possible symptoms of shingles (herpes zoster)) (common) - fever, chills or other symptoms of infections (very common) - low level of red blood cells (anaemia), low level of white blood cells (neutropenia) or low level of platelets (thrombocytopenia) (very common)
Slovenian: Nekateri med njimi so zelo pogosti (do njih pride pri več kot 1 od 10 bolnikov), nekateri pa so pogosti (do njih pride pri največ 1 od 10 bolnikov): - kakršen koli znak krvavitve v možganih, kot so nenadna sprememba stopnje zavesti, trdovraten glavobol, odrevenelost, mravljinčenje, šibkost ali paraliza (pogosti) - kakršen koli znak krvavitve v želodcu ali črevesju, kot so črno ali krvavo blato ali bruhanje krvi
English: A dose modification is recommended in patients with severe renal impairment and end-stage renal disease (see section 4.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo je priporočeno prilagajanje odmerkov (glejte poglavje 4.2).
English: Animal studies have shown that ruxolitinib is embryotoxic and foetotoxic.
Slovenian: Rezultati raziskav na živalih kažejo, da ruksolitinib deluje toksično na zarodek in plod.
English: The rate of herpes zoster was similar in PV (4.3%)
Slovenian: Pogostnost herpesa zostra je bila pri bolnikih s pravo policitemijo podobna (4,3 %) kot pri bolnikih z mielofibrozo (4,0 %).
English: Ruxolitinib decreased foetal weight and increased post-implantation loss in animal studies.
Slovenian: V študijah na živalih je ruksolitinib zmanjšal telesno maso ploda in povečal pogostnost smrti zarodka po nidaciji.
English: Jakavi contains lactose
Slovenian: Zdravilo Jakavi vsebuje laktozo
English: Therefore, no increase in exposure of CYP3A4 substrates is anticipated when combining them with ruxolitinib.
Slovenian: Pri sočasni uporabi z ruksolitinibom se tako ne pričakuje povečane izpostavljenosti substratom za CYP3A4.
English: In the randomised period of the pivotal study in PV patients, the mean systolic blood pressure increased by 0.65 mmHg in the ruxolitinib arm versus a decrease of 2 mmHg in the BAT arm.
Slovenian: V randomiziranem delu ključne študije z bolniki s pravo policitemijo se je pri bolnikih z ruksolitinibom povprečna vrednost sistoličnega krvnega tlaka zvišala za 0,65 mmHg v primerjavi z znižanjem za 2 mmHg pri bolnikih z najboljšim razpoložljivim zdravilom.
English: In COMFORT-I, after a median follow-up of 34.3 months, the death rate in patients randomised to the ruxolitinib arm was 27.1% versus 35.1% in patients randomised to placebo; HR 0.687; 95% CI 0.459-1.029; p=0.0668.
Slovenian: V študiji COMFORT-I je po medianem trajanju spremljanja 34,3 meseca umrlo 27,1 % bolnikov, ki so bili randomizirani na prejemanje ruksolitiniba, v primerjavi s 35,1 % umrlih med bolniki, ki so bili randomizirani na prejemanje placeba (razmerje ogroženosti: 0,687; 95% IZ 0,459-1,029; p=0,0668).
English: Jakavi is also used to treat patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Slovenian: Zdravilo Jakavi uporabljamo tudi za zdravljenje bolnikov s pravo policitemijo, pri katerih ne pride do ustreznega odziva na zdravljenje s hidroksiureo ali je ne prenašajo.
English: Non-melanoma skin cancers (NMSCs), including basal cell, squamous cell, and Merkel cell carcinoma, have been reported in patients treated with ruxolitinib.
Slovenian: Pri bolnikih, ki so prejemali ruksolitinib, so poročali o nemelanomskem kožnem raku, vključno z bazalnoceličnim in ploščatoceličnim karcinomom in karcinomom Merklovih celic.
English: Excipient with known effect Each tablet contains 285.80 mg lactose monohydrate.
Slovenian: Pomožna snov z znanim učinkom Ena tableta vsebuje 285,80 mg laktoze monohidrata.
English: OUTER CARTON OF MULTIPACK
Slovenian: ZUNANJA ŠKATLA ZA SKUPNO PAKIRANJE
English: In the randomised period of the pivotal studies, the rate of patients experiencing thrombocytopenia was lower in PV (16.8%) patients compared to MF (69.8%) patients.
Slovenian: V randomiziranem delu ključnih študij je bila trombocitopenija manj pogosta pri bolnikih s pravo policitemijo (16,8 %) kot pri bolnikih z mielofibrozo (69,8 %).
English: The primary efficacy endpoint was proportion of patients achieving ≥35% reduction from baseline in spleen volume at week 48 as measured by MRI or CT.
Slovenian: Primarni cilj opazovanja za oceno učinkovitosti je bil delež bolnikov, pri katerih je po 48 tednih prišlo do najmanj zmanjšanja volumna vranice za ≥35 % od izhodiščne vrednosti, kar so izmerili s pomočjo MR ali CT slikanja.
English: Talk to your doctor or pharmacist during your treatment with Jakavi - if you experience unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections (these are signs of blood disorders).
Slovenian: (pogosti) - nepričakovan pojav podplutbe in/ali krvavitve, neobičajna utrujenost, zadihanost med naporom ali v mirovanju, neobičajno bleda koža ali pogoste okužbe (kar so lahko simptomi bolezni krvi)
English: Figure 1 Patients achieving the primary endpoint and components of the primary endpoint at week 32
Slovenian: Slika 1: Bolniki, ki so do 32. tedna dosegli primarni cilj opazovanja in vsakega od obeh posameznih ciljev
English: A single dose of 15 mg is recommended for MF patients with platelet count between 100,000/mm and 200,000/mm
Slovenian: Enkraten odmerek 15 mg je priporočen za bolnike z mielofibrozo, ki imajo število trombocitov med 100.000/mm3 in
English: The starting dose of Jakavi should be reduced in patients with severe renal impairment.
Slovenian: Pri bolnikih s hudo okvaro ledvic je treba znižati začetni odmerek zdravila Jakavi.
English: How Jakavi works
Slovenian: Kako deluje zdravilo Jakavi
English: The concomitant use of cytoreductive therapies or haematopoietic growth factors with Jakavi has not been studied.
Slovenian: Sočasne uporabe zdravila Jakavi in citoreduktivnih zdravil ali hematopoetskih rastnih faktorjev niso proučevali.
English: Positive (N=110) n (%)
Slovenian: pozitiven (N=110) n (%)
English: - A subject with multiple occurrence of an adverse drug reaction (ADR) is counted only once in that ADR category.
Slovenian: Oseba, pri kateri se je neželeni učinek zdravila večkrat ponovil, je za to kategorijo pogostnosti šteta samo enkrat.
English: Hepatitis B viral load (HBV-DNA titre) increases, with and without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Jakavi.
Slovenian: Pri bolnikih s kronično okužbo z virusom hepatitisa B (HBV), ki so jemali zdravilo Jakavi, so poročali o povečanju virusnega bremena (titra HBV-DNA) skupaj z zvišanjem vrednosti alanin aminotransferaze in aspartat aminotransferaze ali brez navedenega zvišanja.
English: Excipient with known effect Each tablet contains 71.45 mg lactose monohydrate.
Slovenian: Pomožna snov z znanim učinkom Ena tableta vsebuje 71,45 mg laktoze monohidrata.
English: There have been cases of patients discontinuing Jakavi who sustained more severe events, particularly in the presence of acute intercurrent illness.
Slovenian: V nekaterih primerih je pri bolnikih po prekinitvi jemanja zdravila Jakavi prišlo do resnejših dogodkov, zlasti ob sočasni prisotnosti akutne bolezni, vendar niso ugotovili, ali je prekinitev jemanja zdravila Jakavi prispevala k razvoju omenjenih dogodkov.
English: In healthy subjects co-administration of ruxolitinib (10 mg single dose) with erythromycin 500 mg twice daily for four days resulted in ruxolitinib Cmax and AUC that were higher by 8% and 27%, respectively, than with ruxolitinib alone.
Slovenian: Pri zdravih osebah je bila pri sočasnem odmerjanju ruksolitiniba (v enkratnem odmerku 10 mg) z eritromicinom 500 mg dvakrat na dan štiri dni Cmax ruksolitiniba za 8 % višja, njegova AUC pa za 27 % večja kot pri odmerjanju samo ruksolitiniba.
English: - Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
Slovenian: - Ena 20 mg tableta Jakavi vsebuje 20 mg ruksolitiniba.
English: Jakavi has no or negligible sedating effect.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Jakavi nima oziroma ima zanemarljiv sedativen učinek.
English: There was a 33% reduction in risk of death in the ruxolitinib arm compared to the BAT arm (HR 0.67; 95% CI 0.44-1.02; p=0.062).
Slovenian: V skupini z ruksolitinibom je bilo tveganje za smrt za 33 % manjše kot v skupini z najboljšim razpoložljivim zdravilom (razmerje ogroženosti: 0,67; 95% IZ 0,44-1,02; p=0,062).
English: There are no human data on the effect of ruxolitinib on fertility.
Slovenian: O vplivu ruksolitiniba na plodnost pri človeku ni nobenih podatkov.
English: Positive (N=49) n (%)
Slovenian: pozitiven (N=49) n (%)
English: The recommended starting dose for PV patients with ESRD on haemodialysis is a single dose of 10 mg or two doses of 5 mg given 12 hours apart, to be administered post-dialysis and only on the day of haemodialysis.
Slovenian: Priporočeni začetni odmerek za bolnike s pravo policitemijo in končno ledvično odpovedjo, ki se zdravijo s hemodializo, je enkraten odmerek 10 mg ali dva odmerka po 5 mg z 12-urnim presledkom, kar bolnik prejme po dializi, in sicer samo na dan hemodialize.
English: Clearance was 12.7 l/h in PV patients, with a 42% inter-subject variability and no relationship was apparent between oral clearance and gender, patient age or race, based on a population pharmacokinetic evaluation in PV patients.
Slovenian: Povezanosti med očistkom zdravila po peroralnem vnosu in spolom, starostjo ali raso bolnika pri oceni populacijske farmakokinetike bolnikov s pravo policitemijo niso opažali.
English: The recommended starting dose of ruxolitinib in PV is 10 mg given orally twice daily.
Slovenian: Priporočeni začetni odmerek ruksolitiniba pri pravi policitemiji je 10 mg peroralno dvakrat na dan.
English: Excipient with known effect Each tablet contains 142.90 mg lactose monohydrate.
Slovenian: Pomožna snov z znanim učinkom Ena tableta vsebuje 142,90 mg laktoze monohidrata.
English: The primary composite endpoint was the proportion of patients achieving both an absence of phlebotomy eligibility (HCT control) and a ≥35% reduction in spleen volume from baseline at week 32.
Slovenian: Primarni sestavljeni cilj opazovanja je bil delež bolnikov, ki dosežejo ustrezno vrednost hematokrita, tako da niso več primerni za flebotomijo, hkrati pa pri njih po 32 tednih pride do zmanjšanja volumna vranice za ≥35 % od izhodiščne vrednosti.
English: The starting dose of Jakavi was based on platelet count.
Slovenian: Začetni odmerek zdravila Jakavi je bil določen glede na število trombocitov.
English: Negative (N=35) n (%)
Slovenian: negativen (N=35) n (%)
English: Jakavi 20 mg tablets
Slovenian: Jakavi 20 mg tablete
English: Hepatobiliary disorders Raised alanine aminotransferase b
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišana vrednost alanin-aminotransferaze b stopnje 3 po CTCAE
English: The adverse drug reactions listed below reflect the randomised study period (up to week 32 for RESPONSE and up to week 28 for RESPONSE 2) with equivalent exposure to ruxolitinib and Best Available Therapy (BAT).
Slovenian: Spodaj našteti neželeni učinki zdravila odražajo randomizirano obdobje študije (do konca 32. tedna v študiji RESPONSE in do konca 28. tedna v študiji RESPONSE 2), v katerem so bili bolniki enakomerno razporejeni v dve skupini, tako da so prejemali bodisi ruksolitinib ali pa najboljše razpoložljivo zdravljenje (BAT - Best Available Therapy), pri čemer je mediana trajanja izpostavljenosti zdravilu Jakavi v randomiziranih obdobjih obeh študij znašala 7,85 meseca (od 0,03 do 7,85 meseca).
English: Excipient with known effect Each tablet contains 214.35 mg lactose monohydrate.
Slovenian: Pomožna snov z znanim učinkom Ena tableta vsebuje 214,35 mg laktoze monohidrata.
English: Jakavi 20 mg tablets Each tablet contains 20 mg ruxolitinib (as phosphate).
Slovenian: Jakavi 20 mg tablete Ena tableta vsebuje 20 mg ruksolitiniba (v obliki fosfata).
English: Dose modifications or interruption for patients developing anaemia may also be considered.
Slovenian: Poleg tega je pri njih mogoče razmisliti tudi o spremembi odmerka ali prekinitvi odmerjanja zdravila.
English: Jakavi contains lactose.
Slovenian: Zdravilo Jakavi vsebuje laktozo.
English: Bruising was reported in 10.3% of patients treated with ruxolitinib, 8.1% of patients receiving best available therapy in RESPONSE
Slovenian: O podplutbah so poročali pri 10,3 % bolnikov, ki so prejemali ruksolitinib, pri 8,1 % bolnikov, ki so prejemali najboljše razpoložljivo zdravljenje v študiji RESPONSE, in pri 2,7 % bolnikov, ki so prejemali najboljše razpoložljivo zdravljenje v študiji RESPONSE 2.
English: - A subject with multiple occurrences of an ADR is counted only once in that ADR category.
Slovenian: Oseba, pri kateri se je neželeni učinek večkrat ponovil, je za to kategorijo pogostnosti šteta samo enkrat.
English: Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Type A) Povidone K30
Slovenian: 6.1 Seznam pomožnih snovi mikrokristalna celuloza magnezijev stearat brezvodni koloidni silicijev dioksid natrijev karboksimetilškrob (vrsta A) povidon K30 hidroksipropilceluloza 300 do 600 cps laktoza monohidrat
English: Doses were then adjusted in individual patients based on tolerability and efficacy with a maximum dose of 25 mg twice daily.
Slovenian: Začetni odmerek zdravila Jakavi je bil 10 mg dvakrat na dan. Odmerjanje so nato prilagajali posameznemu bolniku glede na prenašanje in učinkovitost zdravila, pri čemer odmerek ni presegal 25 mg dvakrat na dan.
English: A complete blood cell count, including a white blood cell count differential, must be performed before initiating therapy with Jakavi.
Slovenian: Pred začetkom zdravljenja z zdravilom Jakavi je treba določiti celotno krvno sliko, vključno z diferencialno belo krvno sliko.
English: There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and <100,000/mm 3.
Slovenian: Priporočeni začetni odmerek za bolnike s številom trombocitov med 50.000/mm in <100.000/mm je težko opredeliti, ker je na voljo le malo podatkov.
English: Negative (N=27) n (%)
Slovenian: negativen (N=27) n (%)
English: - Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib.
Slovenian: - Ena 5 mg tableta Jakavi vsebuje 5 mg ruksolitiniba.
English: Negative (N=40) n (%)
Slovenian: negativen (N=40) n (%)
English: Significantly more patients treated with Jakavi (23%) achieved a primary response (p<0.0001) compared to BAT (0.9%).
Slovenian: V skupini z zdravilom Jakavi je bil delež bolnikov, ki so dosegli primarni odziv, statistično značilno večji (23 %) v primerjavi z deležem takih bolnikov v skupini z najboljšim razpoložljivim zdravilom (0,9 %) (p<0,0001).
English: Jakavi 15 mg tablets Each tablet contains 15 mg ruxolitinib (as phosphate).
Slovenian: Jakavi 15 mg tablete Ena tableta vsebuje 15 mg ruksolitiniba (v obliki fosfata).
English: Jakavi 10 mg tablets EU/1/12/773/014-016
Slovenian: Jakavi 10 mg tablete EU/1/12/773/014-016
English: Jakavi 20 mg tablets EU/1/12/773/010-012
Slovenian: Jakavi 20 mg tablete EU/1/12/773/010-012
English: - Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
Slovenian: - Ena 15 mg tableta Jakavi vsebuje 15 mg ruksolitiniba.
English: - Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
Slovenian: - Ena 10 mg tableta Jakavi vsebuje 10 mg ruksolitiniba.
English: Jakavi 5 mg tablets EU/1/12/773/004-006
Slovenian: Jakavi 5 mg tablete EU/1/12/773/004-006
English: Jakavi 10 mg tablets Each tablet contains 10 mg ruxolitinib (as phosphate).
Slovenian: Jakavi 10 mg tablete Ena tableta vsebuje 10 mg ruksolitiniba (v obliki fosfata).
English: Jakavi 15 mg tablets EU/1/12/773/007-009
Slovenian: Jakavi 15 mg tablete EU/1/12/773/007-009
English: Two randomised phase 3 studies (COMFORT-I and COMFORT-II) were conducted in patients with MF (primary MF, post-polycythaemia vera MF or post-essential thrombocythaemia MF).
Slovenian: Pri bolnikih z mielofibrozo (s primarno mielofibrozo, z mielofibrozo pri pravi policitemiji ali z mielofibrozo pri esencialni trombocitemiji) so izvedli dve randomizirani študiji faze 3 (COMFORT-I in COMFORT-II).
English: Strong CYP3A4 inhibitors (such as, but not limited to, boceprevir, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole) In healthy subjects co-administration of ruxolitinib (10 mg single dose) with a strong CYP3A4 inhibitor, ketoconazole, resulted in ruxolitinib Cmax and AUC that were higher by 33% and 91%, respectively, than with ruxolitinib alone.
Slovenian: Močni zaviralci CYP3A4 (kot so med drugim boceprevir, klaritromicin, indinavir, itrakonazol, ketokonazol, lopinavir/ritonavir, ritonavir, mibefradil, nefazodon, nelfinavir, posakonazol, sakvinavir, telaprevir, telitromicin, vorikonazol)
English: 50% dose reduction should be considered when using medicinal products which are dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole).
Slovenian: Pri uporabi zdravil, ki so dvojni zaviralci CYP2C9 in CYP3A4 (na primer flukonazola), je treba razmisliti o znižanju odmerjanja za 50 %.
English: Jakavi 10 mg tablets
Slovenian: Jakavi 10 mg tablete
English: Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side.
Slovenian: Jakavi 20 mg tablete so bele do skoraj bele podolgovate tablete z vtisnjeno oznako “NVR” na eni strani in “L20” na drugi.
English: Withdrawal effects
Slovenian: Odtegnitvene reakcije
English: How to store Jakavi
Slovenian: Shranjevanje zdravila Jakavi
English: Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side.
Slovenian: Okroglo zaobljene, bele do skoraj bele tablete premera približno 9,3 mm, z vtisnjeno oznako “NVR” na eni strani in “L10” na drugi.
English: These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
Slovenian: To so lahko znaki resne možganske okužbe, zato vam bo zdravnik morda predlagal nadaljnje preiskave in spremljanje stanja; - če se vam razvije boleč kožni izpuščaj z mehurčki (to so znaki pasavca); - če opazite spremembe na koži.
English: The proportion of patients achieving a complete haematological remission was 23.6% on Jakavi compared to 8.0% on BAT (p=0.0013) and the proportion of patients achieving a durable primary response at week 48 was 20% on Jakavi and 0.9% on BAT (p<0.0001).
Slovenian: Delež bolnikov, ki so dosegli popolno hematološko remisijo, je bil v skupini z zdravilom Jakavi 23,6 % v primerjavi z 8,0 % bolnikov v skupini z najboljšim razpoložljivim zdravilom (p=0,0013).
English: There was no clinically relevant change in the pharmacokinetics of ruxolitinib upon administration with a high-fat meal.
Slovenian: Po zaužitju ruksolitiniba skupaj z obrokom z veliko vsebnostjo maščob ni prišlo do klinično pomembnih sprememb farmakokinetičnih lastnosti ruksolitiniba.
English: No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors (e.g. erythromycin).
Slovenian: Pri sočasni uporabi ruksolitiniba s šibkimi oziroma zmernimi zaviralci CYP3A4 (na primer z eritromicinom) ni priporočeno posebno prilagajanje odmerkov.
English: Jakavi 15 mg tablets
Slovenian: Jakavi 15 mg tablete
English: Jakavi 5 mg tablets
Slovenian: Jakavi 5 mg tablete
English: Stopping Jakavi
Slovenian: Prekinitev jemanja zdravila Jakavi
English: Jakavi contains the active substance ruxolitinib.
Slovenian: Zdravilo Jakavi vsebuje učinkovino ruksolitinib.
English: Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side.
Slovenian: Podolgovate zaobljene, bele do skoraj bele tablete, velikosti približno 16,5 x 7,4 mm, z vtisnjeno oznako “NVR” na eni strani in “L20” na drugi.
English: It has been observed that patients with low platelet counts (<200,000/mm 3) at the start of therapy are more likely to develop thrombocytopenia during treatment.
Slovenian: Opažali so, da so bili bolniki, ki so imeli na začetku zdravljenja nizko število trombocitov (<200.000/mm
English: Jakavi 15 mg tablets are white to almost white oval tablets with “NVR” debossed on one side and “L15” debossed on the other side.
Slovenian: Jakavi 15 mg tablete so bele do skoraj bele ovalne tablete z vtisnjeno oznako “NVR” na eni strani in “L15” na drugi.
English: Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side.
Slovenian: Okroglo zaobljene, bele do skoraj bele tablete premera približno 7,5 mm, z vtisnjeno oznako “NVR” na eni strani in “L5” na drugi.
English: Discontinuation of treatment because of thrombocytopenia occurred in 0.7% of patients receiving ruxolitinib and 0.9%
Slovenian: Do prekinitve zdravljenja zaradi trombocitopenije je prišlo pri 0,7 % bolnikov, ki so prejemali ruksolitinib, in pri 0,9 % tistih bolnikov, ki so prejemali kontrolne sheme zdravljenja.
English: - if you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision.
Slovenian: V času zdravljenja z zdravilom Jakavi se pogovorite z zdravnikom ali farmacevtom: - če opazite nepričakovano pojavljanje podplutb in/ali krvavitev, neobičajno utrujenost, zadihanost pri naporu ali v mirovanju, neobičajno bledo kožo ali pogoste okužbe (to so znaki bolezni krvi); - če opazite zvišano telesno temperaturo, mrazenje ali druge simptome okužbe; - če kašljate daljše obdobje in pri tem izkašljujete izmeček s sledovi krvi, imate zvišano telesno temperaturo, se ponoči znojite in se vam zmanjšuje telesna masa (kar so lahko znaki tuberkuloze); - če se pri vas pojavi kateri od naslednjih simptomov ali če kdo od vaših bližnjih opazi, da se je pri vas pojavil kateri od naslednjih simptomov: zmedenost ali oteženo razmišljanje, motnje ravnotežja ali težave pri hoji, okornost, oteženo govorjenje, zmanjšana mišična moč oziroma šibkost na eni strani telesa, zamegljen vid in/ali izguba vida.