natgillin/translations-raw huggingface dataset:
If the treatment is not considered effective enough, the dose can be increased by 5 mg up to 25 mg twice a day.
Če se zdravljenje ne zdi dovolj učinkovito, se lahko odmerek poveča za 5 mg do 25 mg dvakrat na dan.
The full EPAR for Jakavi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Jakavi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
With regard to safety, the Committee considered that the risk of infections is acceptable but should be monitored further, while other known risks, such as bleeding or a reduction in blood cell counts, can be appropriately managed.
V zvezi z varnostjo je menil, da je tveganje okužb sprejemljivo, vendar ga je treba še naprej nadzirati, druga znana tveganja, kot so krvavitev ali zmanjšanje števila krvnih celic, pa je mogoče ustrezno obravnavati.
Other information about Jakavi
Druge informacije o zdravilu Jakavi
The main measure of effectiveness was the proportion of patients whose spleen had reduced in size by at least 35%, measured after six months in the first study and after one year in the second study.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je velikost vranice zmanjšala za vsaj 35 %, izmerjeno po šestih mesecih v prvi študiji, in po enem letu v drugi študiji.
This is a summary of the European public assessment report (EPAR) for Jakavi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jakavi.
Jakavi is used to treat the following conditions:
Zdravilo Jakavi se uporablja za zdravljenje naslednjih bolezni:
What benefit has Jakavi shown during the studies?
Kakšne koristi je zdravilo Jakavi izkazalo med študijami?
In polycythaemia vera treatment should also be stopped when haemoglobin levels are very low.
Pri pravi policitemiji je treba zdravljenje prekiniti, kadar so ravni hemoglobina zelo nizke.
For more information about treatment with Jakavi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Jakavi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
These blood cells migrate to organs including the spleen, causing them to become enlarged.
Te krvne celice potujejo do organov, vključno z vranico, ki se zaradi tega povečajo.
A risk management plan has been developed to ensure that Jakavi is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Jakavi je bil pripravljen načrt obvladovanja tveganj.
The CHMP decided that Jakavi's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Jakavi večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The second study compared Jakavi with the best available treatment, which included different types of medicines such as anti-cancer agents, hormones and immunosuppressants.
V drugi študiji so zdravilo Jakavi primerjali z najboljšo razpoložljivo obliko zdravljenja, ki vključuje različne vrste zdravil, kot so zdravila proti raku, hormoni in imunosupresivi.
In polycythaemia vera, the company will extend the main study to provide long-term data on the safety and effectiveness of Jakavi.
V zvezi s pravo policitemijo bo družba podaljšala glavno študijo, da bo zbrala dolgoročne podatke o varnosti in učinkovitosti zdravila Jakavi.
What is the risk associated with Jakavi?
Kakšna tveganja so povezana z zdravilom Jakavi?
Treatment should be stopped if the patient's blood levels of platelets or neutrophils (a type of white blood cell) fall below certain thresholds, or if no improvement in spleen size or symptoms is seen after six months.
Zdravljenje je treba prekiniti, če se vrednosti krvnih ploščic ali nevtrofilcev (vrste belih krvnih celic) v bolnikovi krvi znižajo pod določeno vrednost ali če se velikost vranice ali simptomi po šestih mesecih zdravljenja ne izboljšajo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jakavi.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The patient's complete blood cell count must be taken before starting treatment and monitored during treatment.
Pred začetkom zdravljenja je treba opraviti pregled bolnikove krvne slike in jo med zdravljenjem nadzirati.
Treatment with Jakavi should only be started by a doctor who is experienced in treating patients with cancer medicines.
Zdravljenje z zdravilom Jakavi mora uvesti zdravnik z izkušnjami pri zdravljenju bolnikov z zdravili proti raku.
• myelofibrosis in adults who have splenomegaly (enlarged spleen) or symptoms related to the disease such as fever, night sweats, bone pain and weight loss.
• mielofibroze pri odraslih, ki imajo splenomegalijo (povečano vranico) ali simptome, povezane z boleznijo, kot so povišana telesna temperatura, nočno potenje, bolečine v kosteh in izguba telesne mase.
This study, which compared Jakavi with best available treatment, looked at the percentage of patients who showed improvement in their condition, measured as requiring none or no more than one phlebotomy (a procedure to remove excess blood from the body) and whose spleen reduced by at least 35% in size, after 8 months of treatment.
V tej študiji, v kateri so zdravilo Jakavi primerjali z najboljšim razpoložljivim zdravljenjem, so proučevali pri kolikšnem deležu bolnikov je bilo opaziti izboljšanje stanja, tj. da bolnik ni potreboval nobene flebotomije ali ne več kot eno (postopek, pri katerem se odstrani presežna količina krvi iz telesa) in pri katerih se je velikost vranice po osmih mesecih zdravljenja zmanjšala za vsaj 35 %.
The Committee noted that the quality of life of patients treated with Jakavi was improved but that the medicine's effects had still to be evaluated in terms of extending the life of patients or delaying the progress of the disease or the onset of leukaemia.
Ugotovil je, da se je kakovost življenja bolnikov, zdravljenih z zdravilom Jakavi, izboljšala, vendar pa je treba učinke zdravila na podaljšanje življenja bolnikov ali upočasnitev napredovanja bolezni ali pojava levkemije še oceniti.
In addition, the company that makes Jakavi is extending the main studies on myelofibrosis and will provide annual data on the effects of Jakavi in terms of how long patients live and how long they live without their disease getting worse or developing leukaemia.
Poleg tega je družba, ki izdeluje zdravilo Jakavi, podaljšala glavne študije o mielofibrozi in bo vsako leto predložila podatke o učinkih zdravila Jakavi na dolžino življenja bolnikov in dolžino življenja bolnikov brez poslabšanja bolezni ali nastanka levkemije.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jakavi, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Jakavi is a medicine that contains the active substance ruxolitinib.
Jakavi je zdravilo, ki vsebuje zdravilno učinkovino ruksolitinib.
For the full list of all side effects and restrictions with Jakavi, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Jakavi glejte navodilo za uporabo.
In polycythaemia vera, the recommended starting dose is 10 mg twice a day.
Pri pravi policitemiji je priporočeni začetni odmerek 10 mg dvakrat na dan.
A lower dose should be used in certain cases, including in patients reduced liver function or severely reduced kidney function, and in patients taking certain other medicines.
V nekaterih primerih, kot so bolniki z oslabljenim delovanjem jeter ali hudo oslabljenim delovanjem ledvic ter pri bolnikih, ki jemljejo nekatera druga zdravila, je treba uporabiti nižji odmerek.
The active substance in Jakavi, ruxolitinib, works by blocking a group of enzymes known as Janus kinases (JAKs), which are involved in the production and growth of blood cells.
Zdravilna učinkovina v zdravilu Jakavi, ruksolitinib, zavira skupino encimov, ki se imenujejo Janusove kinaze (JAK) ter sodelujejo pri nastajanju in rasti krvnih celic.
Why has Jakavi been approved?
Zakaj je bilo zdravilo Jakavi odobreno?
Myelofibrosis is a disease in which the bone marrow becomes very dense and rigid and produces abnormal, immature blood cells.
Mielofibroza je bolezen, pri kateri se kostni mozeg močno zgosti in otrdi in proizvaja nenormalne, nezrele krvne celice.
By blocking JAKs, Jakavi reduces the abnormal production of blood cells, thereby reducing the symptoms of the diseases.
Z zaviranjem encimov JAK zdravilo Jakavi zmanjša nenormalno tvorbo krvnih celic, s čimer se zmanjšajo simptomi bolezni.
In myelofibrosis, Jakavi was more effective than placebo and the best available treatment at reducing the size of the spleen.
Pri mielofibrozi je bilo zdravilo Jakavi pri zmanjševanju velikosti vranice učinkovitejše od placeba in najboljše razpoložljive oblike zdravljenja.
In myelofibrosis, the recommended starting dose is up to 20 mg twice a day depending on the platelet count.
Pri mielofibrozi je priporočeni začetni odmerek do 20 mg dvakrat na dan, odvisno od števila krvnih ploščic.
In the first study, the target reduction in spleen size was achieved in 42% of patients treated with Jakavi (65 out of 155) compared with less than 1% of patients given placebo (1 out of 153).
V prvi študiji je bilo ciljno zmanjšanje velikosti vranice doseženo pri 42 % (65 od 155) bolnikov, zdravljenih z zdravilom Jakavi, v primerjavi z manj kot 1 % (1 od 153) bolnikov, ki so prejemali placebo.
In polycythaemia vera, 21% (23 out of 110) of patients given Jakavi showed an improvement after 8 months of treatment, compared with 1% (1 out of 112) of patients given the best available treatment.
Pri pravi policitemiji je bilo pri 21 % (23 od 110) bolnikih, zdravljenih z zdravilom Jakavi, po osmih mesecih zdravljenja opaziti izboljšanje, v primerjavi z 1 % (1 od 112) bolnikov, ki so prejemali najboljšo razpoložljivo obliko zdravljenja.
In polycythaemia vera, Jakavi was studied in one main study which involved 222 patients who were resistant or intolerant to treatment with hydroxyurea.
Pri pravi policitemiji so zdravilo Jakavi proučevali v eni glavni študiji, ki je vključevala 222 bolnikov, ki se niso odzivali na zdravljenje s hidroksisečnino ali je ne prenašajo.
The first study compared Jakavi with placebo (a dummy treatment).
V prvi študiji so zdravilo Jakavi primerjali s placebom (zdravilom brez zdravilne učinkovine).
In the second study, the target reduction in spleen size was achieved in 29% of patients treated with Jakavi (41 out of 144) compared with 0% of patients receiving the best available treatment (0 out of 72).
V drugi študiji je bilo ciljno zmanjšanje velikosti vranice doseženo pri 29 % (41 od 144) bolnikov, zdravljenih z zdravilom Jakavi, v primerjavi z 0 % (0 od 72) bolnikov, ki so prejemali najboljšo razpoložljivo obliko zdravljenja.
In myelofibrosis the CHMP considered that the reduction in spleen size and symptoms seen in patients taking Jakavi is clinically important.
Menil je, da je zmanjšanje velikosti vranice in simptomov pri bolnikih, ki so jemali zdravilo Jakavi, klinično pomembno.
• polycythaemia vera in adults who are resistant or intolerant to treatment with the medicine hydroxyurea.
• prave policitemije pri odraslih, ki se ne odzivajo na zdravljenje s hidroksisečnino ali je ne prenašajo.
In myelofibrosis, Jakavi was investigated in two main studies involving 528 patients.
Zdravilo Jakavi so proučevali v dveh glavnih študijah, ki sta vključevali 528 bolnikov z mielofibrozo.
Jakavi can be used in three types of the disease: primary myelofibrosis (also known as chronic idiopathic myelofibrosis, where the cause is unknown), post-polycythaemia vera myelofibrosis (where the disease is linked to an overproduction of red blood cells) and postessential thrombocythaemia myelofibrosis (where the disease is linked to an overproduction of platelets, components that help the blood to clot).
Zdravilo Jakavi se lahko uporablja pri treh vrstah bolezni: primarni mielofibrozi (znani tudi kot kronična idiopatska mielofibroza iz neznanih vzrokov), mielofibrozi po pravi policitemiji (ko je bolezen povezana s prevelikim nastajanjem rdečih krvnih celic) in mielofibrozi po esencialni trombocitemiji (ko je bolezen povezana s prekomernim nastajanjem krvnih ploščic, ki pomagajo pri strjevanju krvi);
In polycythaemia vera, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), bleeding, bruising, hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridemia (high blood fat levels), dizziness, raised liver enzyme levels and high blood pressure.
Pri pravi policitemiji so najpogostejši neželeni učinki zdravila Jakavi (opaženi pri več kot 1 bolniku od 10) trombocitopenija (nizko število krvnih ploščic), anemija (nizko število rdečih krvnih celic), krvavitve, podplutbe, hiperholesterolemija (visoke ravni holesterola v krvi), hipertrigliceridemija (visoka raven maščob v krvi), omotica, povečane ravni jetrnih encimov in visok krvni tlak.
How has Jakavi been studied?
Kako je bilo zdravilo Jakavi raziskano?
Polycythaemia vera is a disease that mainly causes too many red blood cells to be produced, which can cause reduced blood flow to the organs due to ‘thickening' of the blood and occasionally the formation of blood clots.
Prava policitemija je bolezen, pri kateri nastaja preveč rdečih krvnih celic, zaradi česar se kri zgoščuje, kar povzroča zmanjšan pretok krvi do organov.
What is Jakavi used for?
Za kaj se zdravilo Jakavi uporablja?
In myelofibrosis, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils), urinary tract infections (infection of the structures that carry urine), bleeding, bruising, weight gain, hypercholesterolaemia (high blood cholesterol levels), dizziness, headache and raised liver enzyme levels.
Pri mielofibrozi so najpogostejši neželeni učinki zdravila Jakavi (opaženi pri več kot 1 bolniku od 10) trombocitopenija (nizko število krvnih ploščic), anemija (nizko število rdečih krvnih celic), nevtropenija (nizko število nevtrofilcev), okužbe sečil (okužbe struktur za odvajanje urina), krvavitve, podplutbe, povečanje telesne mase, hiperholesterolemija (visoke ravni holesterola v krvi), omotica, glavobol in zvišane vrednosti jetrnega encima.
In polycythaemia vera the CHMP considered that Jakavi is of benefit to patients who do not respond or are intolerant to treatment with hydroxyurea, while the safety profile is acceptable.
V zvezi s pravo policitemijo je menil, da zdravilo Jakavi koristi bolnikom, ki se ne odzivajo na zdravljenje s hidroksisečnino ali je ne prenašajo.
In myelofibrosis and polycythaemia vera, there is too much JAK activity, leading to the abnormal production of blood cells.
Pri mielofibrozi in pravi policitemiji je dejavnost encimov JAK prehuda, kar vodi do nenormalne tvorbe krvnih celic.
Jakavi must not be used in women who are pregnant or breastfeeding.
Nosečnice ali ženske, ki dojijo, zdravila Jakavi ne smejo jemati.
What is Jakavi?
Kaj je zdravilo Jakavi?
How does Jakavi work?
Kako zdravilo Jakavi deluje?
How is Jakavi used?
Kako se zdravilo Jakavi uporablja?
Date of first authorisation: 21 April 2008 Date of latest renewal: 20 December 2012
Datum prve odobritve: 21 april 2008 Datum zadnjega podaljšanja: 20 december 2012
Table 2 summarises the primary efficacy endpoint results:
V tabeli 2 so povzeti izidi primarnih opazovanih dogodkov učinkovitosti:
Not everyone gets flares, but you could get a flare-up even if you are taking ADENURIC, and especially during the first weeks or months of treatment.
Do izbruha ne pride pri vseh ljudeh, vendar se lahko pojavi tudi, če jemljete zdravilo ADENURIC, še zlasti v prvih tednih ali mesecih zdravljenja.
Your doctor might decide to permanently stop treatment with ADENURIC.
Vaš zdravnik se lahko odloči, da za stalno prekine zdravljenje z zdravilom Adenuric.
BL 2 4 6 8 12 16 20 24 28 32 36 40 44 48 52
BL 2 4 6 8 12 16 20 24 28 32 36 40 44 48 52 Teden
Over time, gout flares will occur less often and be less painful if you keep taking ADENURIC every day.
Čez čas se bodo izbruhi protina pojavljali manj pogosto in bodo manj boleči, če boste nadaljevali z jemanjem zdravila ADENURIC vsak dan.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICITONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
The efficacy and safety of ADENURIC in the prevention and treatment of Tumor Lysis Syndrome was evaluated in the FLORENCE (FLO-01) study.
Učinkovitost in varnost zdravila ADENURIC pri preventivi in zdravljenju sindroma tumorske lize sta bili ocenjeni v študiji FLORENCE (FLO-01).
The requirements for submission of periodic safety updated reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redna posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
• If you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section
• če ste alergični na febuksostat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Should you experience allergic reactions to ADENURIC, stop taking this medicine (see also section 4).
Če se med zdravljenjem z zdravilom ADENURIC pojavijo alergijske reakcije, prenehajte jemati zdravilo (glejte tudi poglavje 4).
Plasma protein binding of the active metabolites ranges from about 82% to 91%.
Delež vezave aktivnih presnovkov na plazemske beljakovine je približno 82 % do 91 %.
14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets
14 filmsko obloženih tablet 28 filmsko obloženih tablet 42 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet
In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.
V primeru nenamerno vzetega prevelikega odmerka se o tem, kaj morate storiti, posvetujte s svojim zdravnikom ali pojdite v najbližji urgentni oddelek za nezgode in nujne primere.
If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine.
Če se pri vas razvije izpuščaj ali ti kožni simptomi, se nemudoma posvetujte z zdravnikom in mu povejte, da jemljete to zdravilo.
Febuxostat tablets contain lactose.
Tablete febuksostata vsebujejo laktozo.
About 69 % of patients required no treatment change to achieve a final stable treatment.
Približno 69 % zdravljenih bolnikov je doseglo končno stabilno stanje brez potrebne spremembe režima zdravljenja.
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with ADENURIC and your doctor may wish to consider necessary measures:
Zlasti pomembno je, da zdravnika ali farmacevta obvestite, če jemljete zdravila, ki vsebujejo katero od naslednjih učinkovin, da bo vaš zdravnik ocenil, ali so potrebni ustrezni ukrepi, saj lahko pride do medsebojnega delovanja z zdravilom ADENURIC:
The effect of ADENURIC on human fertility is unknown.
Učinek zdravila ADENURIC na plodnost pri človeku ni znan.
The endpoints (primary and secondary) were analysed according to the intention-to-treat (ITT) analysis including all subjects who were randomized and received at least one dose of double-blind study medication.
Opazovane dogodke (primarne in sekundarne) so preučili v skladu z analizo vključenih bolnikov (ITT - Intention-To-Treat), ki je vključevala vse bolnike, ki so bili randomizirani in so prejeli vsaj en odmerek dvojno slepega zdravila v preskušanju.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8).
Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov navedeno v poglavju 6.1 (glejte tudi poglavje 4.8).
What ADENURIC is and what it is used for
Kaj je zdravilo ADENURIC in za kaj ga uporabljamo
Furthermore, the mean serum uric acid level was significantly lower with ADENURIC since the first 24 hours of treatment and at any following time point.
Tudi srednja serumska vrednost sečne kisline je bila značilno manjša pri uporabi zdravila ADENURIC od prvih 24 ur zdravljenja naprej in v vseh nadaljnih časovnih točkah.
If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with ADENURIC.
Če imate trenutno izbruh protina (nenadni občutek hude bolečine, napetosti, pordelosti, toplote in oteklosti sklepa), počakajte, da izbruh protina mine, preden začnete zdravljenje z zdravilom ADENURIC.
Liver function test is recommended prior to the initiation of therapy with febuxostat and periodically thereafter based on clinical judgment (see section 5.1).
Preverjanje delovanja jeter se priporoča pred začetkom zdravljenja s febuksostatom in nato periodično v skladu s klinično presojo (glejte poglavje
ADENURIC is for adults.
Zdravilo ADENURIC je za odrasle.
ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule shaped.
Filmsko obložene tablete ADENURIC so svetlorumene do rumene barve v obliki kapsul.
Following multiple oral doses of ADENURIC, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Po večkratnih peroralnih odmerkih zdravila ADENURIC sta bili Cmax za 24 % in AUC za 12 % večji pri ženskah kot pri moških.
• severe swelling of the deeper layers of the skin, especially around the lips, eyes, genitals, hands, feet or tongue, with possible sudden difficult breathing
• Hudo otekanje spodnjih slojev kože, predvsem v področju ustnic, oči, spolovil, dlani, stopal ali jezika, z možno nenadno otežitvijo dihanja.
• If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment of Gout)
• če imate ali ste imeli bolezen ledvic in/ali resne alergijske reakcije na alopurinol (zdravilo za zdravljenje protina),
Overall, the FLORENCE trial did not highlight any particular safety concern in addition to the previous experience with ADENURIC in gout, with the exception of the following three adverse reactions (listed above in table 1).
Na splošno v FLORENCE študiji, glede na prejšnje izkušnje z zdravljenjem protina z zdravilom ADENURIC, niso izpostavili nobenih posebnih varnostnih težav, z izjemo treh naslednjih neželenih učinkov (navedenih v Tabeli 1 zgoraj):
BL=baseline SEM=standard error of the mean
BL=izhodišče SEM=standardna napaka srednje vrednosti