FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains 55.8 mg sodium (main component of cooking/table salt) in each daily dose (4 tablets).
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Stivarga To zdravilo vsebuje ali 55,8 mg natrija (glavne sestavine kuhinjske soli) na dnevni odmerek (4 tablete).
English: ≤5 times upper limit of normal (ULN) (maximum Grade 2)
Slovenian: (ULN - Upper Limit of Normal)
English: Monitor liver function weekly until resolution or return to baseline.
Slovenian: Delovanje jeter je treba spremljati vsak teden do izboljšanja ali dokler se delovanje jeter ne vrne na izhodiščno stanje.
English: Abnormalities of liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with Stivarga.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Stivarga, so pogosto opazili odstopanja v izvidih preiskav delovanja jeter (alanin aminotransferaze [ALT], aspartat aminotransferaze [AST] in bilirubina).
English: OS
Slovenian: vsi
English: The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (RESORCE) in patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Slovenian: Klinična učinkovitost in varnost zdravila Stivarga sta bili ocenjeni v mednarodni, multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani študiji III. faze (RESORCE) pri bolnikih z rakom jetrnih celic, ki so bili predhodno zdravljeni s sorafenibom.
English: However, patients could continue Stivarga therapy past progression at the discretion of the investigator.
Slovenian: Po presoji raziskovalca so bolniki lahko nadaljevali zdravljenje z zdravilom Stivarga tudi po napredovanju bolezni.
English: In clinical trials, a higher incidence of severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga, compared with Caucasians (see section 4.2).
Slovenian: V kliničnih preskušanjih so večjo incidenco hudih odstopanj v izvidih preiskav delovanja jeter in moteno delovanje jeter opazili pri bolnikih azijske rase (predvsem pri Japoncih) zdravljenih z zdravilom Stivarga, v primerjavi z belci (glejte poglavje 4.2).
English: Discontinue treatment with Stivarga permanently.
Slovenian: Trajno prenehanje zdravljenja z zdravilom Stivarga.
English: The mean daily regorafenib dose received was 140 mg.
Slovenian: Povprečni dnevni odmerek regorafeniba je bil 140 mg.
English: Avoid drinking grapefruit juice while taking Stivarga.
Slovenian: Med jemanjem zdravila Stivarga ne pijte soka grenivke, ker lahko vpliva na delovanje zdravila Stivarga.
English: No dosage adjustment is necessary if you have a mildly, moderately or severely impaired kidney function.
Slovenian: Pri blagi, zmerni ali hudi okvari ledvic odmerka ni treba prilagajati.
English: TTP was significantly longer in patients receiving regorafenib plus BSC than in patients receiving placebo plus BSC with a hazard ratio of 0.248 [95% CI 0.170, 0.364], and median TTP of 5.4 months vs. 0.9 months (p<0.000001) (see Table 6).
Slovenian: Čas do napredovanja bolezni (TTP - Time To Progression) je bil pri bolnikih, ki so prejemali regorafenib in najboljšo podporno oskrbo, značilno daljši kot pri bolnikih, ki so prejemali placebo in najboljšo podporno oskrbo, z razmerjem ogroženosti 0,248 [95 % IZ 0,170; 0,364] in mediano TTP 5,4 meseca v primerjavi z 0,9 meseci (p < 0,000001) (glejte preglednico 6).
English: TTP
Slovenian: Tlf.
English: There is no relevant use of Stivarga in the paediatric population in the indication of hepatocellular carcinoma.
Slovenian: Zdravilo Stivarga ni namenjeno za uporabo pri pediatrični populaciji za indikacijo raka jetrnih celic.
English: - signs/symptoms of an allergic reaction which may include widespread severe rash, feeling sick, fever, breathlessness, jaundice, changes in chemicals produced by the liver
Slovenian: - znaki/simptomi alergijske reakcije, ki lahko vključujejo obsežen hud izpuščaj, občutek slabosti,
English: - certain skin cancers (keratoacanthoma/squamous cell carcinoma of the skin) - headache, confusion, seizures and visual loss associated with or without high blood pressure (posterior reversible encephalopathy syndrome/PRES) - serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis).
Slovenian: - določene vrste kožnega raka (keratoakantom/ploščatocelični karcinom kože) - glavobol, zmedenost, epileptični napadi in izguba vida, povezana z visokim krvnim tlakom ali brez njega (sindrom posteriorne reverzibilne encefalopatije (PRES))
English: The addition of Stivarga to BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with a hazard ratio of 0.624 [95% CI 0.498, 0.782], p=0.000017 stratified log rank test, and a median OS of 10.6 months vs. 7.8 months (see Table 7 and Figure 4).
Slovenian: Dodatna uporaba zdravila Stivarga k najboljši podporni oskrbi kaže statistično značilno izboljšanje celokupnega preživetja (OS - Overall Survival) v primerjavi s kombinacijo placeba in najboljše podporne oskrbe z razmerjem ogroženosti 0,624 [95 % IZ 0,498, 0,782], p = 0,000017 stratificiran log-rank test, in mediana celokupnega preživetja (OS - Overall Survival) 10,6 mesecev oziroma 7,8 mesecev (glejte preglednico 7 in sliko 4).
English: Important information about some of the ingredients of Stivarga
Slovenian: Pomembne informacije o nekaterih sestavinah
English: Rare side effects (may affect up to 1 in 1,000 users)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: Thrombocytopenia Anaemia
Slovenian: Trombo citopenija anemija levkopenija
English: Thrombocytopenia Neutropenia Lymphopenia Metabolism and nutrition disorders Hypocalcaemia Hypokalemia Hypophosphatemia
Slovenian: Presnovne in prehranske motnje hipokalciemija hipokaliemija hipofosfatemija
English: Stivarga is used to treat: - colon or rectal cancer that has spread to other parts of the body in adult patients who have received other treatments or cannot be treated with other medicines (fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy)
Slovenian: Zdravilo Stivarga se uporablja za zdravljenje: - raka debelega črevesa ali danke, ki se je razširil na druge dele telesa, pri odraslih bolnikih, ki so že prejeli druge oblike zdravljenja, ali jih ni mogoče zdraviti z drugimi zdravili (kemoterapija na osnovi fluoropirimidina, zaviralci VEGF in zaviralci EGFR); - gastrointestinalnih stromalnih tumorjev (GIST), vrsto raka želodca in črevesja, ki se je razširil na druge dele telesa ali ga ni mogoče operirati, pri odraslih bolnikih, ki so se pred tem zdravili z drugimi zdravili proti raku (imatinib in sunitinib); - rak jeter pri odraslih bolnikih, ki so se pred tem zdravili z drugimi zdravili proti raku (sorafenib).
English: It is not known whether Stivarga alters the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali zdravilo Stivarga vpliva na sposobnost vožnje ali upravljanje strojev.
English: Mild, indirect (unconjugated) hyperbilirubinaemia may occur in patients with Gilbert's syndrome.
Slovenian: Pri bolnikih z Gilbertovim sindromom se lahko pojavi blaga, indirektna (nekonjugirana) hiperbilirubinemija.
English: Stivarga plus BSC (n=132)
Slovenian: Stivarga (N=133)
English: The relative risk of disease progression or death was reduced by approximately 73.2% in regorafenib-treated patients, compared to placebo treated patients (see Table 6, Figure 2).The increase in PFS was consistent independent of age, sex, geographic region, prior lines of treatment, ECOG PS.
Slovenian: Relativno tveganje za napredovanje bolezni ali smrt se je pri bolnikih, zdravljenih z regorafenibom, zmanjšalo za približno 73,2 %, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 6, sliko 2).
English: Placebo plus BSC (n=193)
Slovenian: placebo (N = 194)
English: Bayer d. o. o. Tel.: +386-(0)1-58 14 400
Slovenian: Tel.: +386-(0)1-58 14 400
English: The addition of Stivarga to BSC resulted in a significantly longer survival, compared to placebo plus BSC with a hazard ratio of 0.550 (p = 0.000159 stratified log rank test) and a median OS of 8.8 months vs. 6.3 months [95% CI 0.395, 0.765].
Slovenian: Dodatno zdravljenje z zdravilom Stivarga in najboljša podporna oskrba sta pomembno podaljšala preživetje v primerjavi s placebom in najboljšo podporno oskrbo z razmerjem ogroženosti 0,550 (p = 0,000159 stratificiran log-rank test) in mediano celokupnega preživetja 8,8 mesecev v primerjavi s 6,3 meseci [95 % IZ 0,395; 0,765].
English: Severe liver injury*#
Slovenian: stopnja nadzora nad boleznijo**#
English: weakness or pain (peripheral neuropathy) - taste disorders - dry mouth - heartburn (gastro-oesophageal reflux) - infection or irritation of the stomach and intestines (gastroenteritis) - hair loss (alopecia) - dry skin - rash with flaking or peeling of skin (exfoliative rash) - a sudden, involuntary contraction of a muscle (muscle spasms) - protein in the urine (proteinuria) - high levels of certain enzymes involved in digestion (increase in amylase and lipase) - abnormal blood clotting condition (abnormal International Normalized Ratio).
Slovenian: - okužba ali draženje v želodcu in črevesju (gastroenteritis) - izpadanje las (alopecija) - suha koža - izpuščaj z odstopanjem vrhnjih plasti kože ali luščenjem kože (eksfoliativni izpuščaj) - nenadno, nenamerno krčenje mišic (mišični spazmi) - beljakovine v seču (proteinurija)
English: Median (95% CI) Stivarga plus BSC§ (N=505)
Slovenian: Stivarga (N = 505) placebo (N = 255)
English: Uncommon side effects (may affect up to 1 in 100 users)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: They are classified according to System Organ Class and the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Slovenian: Za opis določenega učinka, njegovih sinonimov in sorodnih stanj so uporabljeni najustreznejši izrazi po klasifikaciji MedDRA.
English: - if you experience skin problems Stivarga can cause redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
Slovenian: Zdravilo Stivarga lahko povzroči rdečino, bolečino, oteklino ali mehurje na dlaneh ali podplatih.
English: Re-occurrence
Slovenian: Pojavnost
English: A dose re-escalation is permitted at the discretion of the physician.
Slovenian: Po presoji zdravnika se lahko odmerek ponovno poveča.
English: Grade a
Slovenian: PRILOGA I
English: Muscle spasms
Slovenian: Stivarga placebo
English: or a tear in a blood vessel wall.
Slovenian: - kri v seču,
English: Regorafenib plus BSC resulted in significantly longer PFS, compared to placebo plus BSC with a hazard ratio of 0.268 [95% CI 0.185, 0.388] and a median PFS of 4.8 months vs. 0.9 months (p < 0.000001).
Slovenian: Regorafenib in najboljša podporna oskrba sta pomembno podaljšala PFS v primerjavi s placebom in najboljšo podporno oskrbo z razmerjem ogroženosti 0,268 [95 % IZ 0,185; 0,388] in mediano preživetja brez napredovanja bolezni 4,8 meseca v primerjavi z 0,9 meseca (p < 0,000001).
English: There was no indication for a genotoxic potential of regorafenib tested in standard assays in vitro and in vivo in mice.
Slovenian: Genotoksičnost in kancerogenost Standardni preskusi in vitro ter in vivo pri miših niso pokazali genotoksičnega potenciala regorafeniba.
English: Grade
Slovenian: AST
English: Talk to your doctor or pharmacist before taking Stivarga.
Slovenian: Pred začetkom jemanja zdravila Stivarga se posvetujte z zdravnikom ali farmacevtom.
English: Keep the desiccant in the bottle.
Slovenian: Sušilno sredstvo pustite v plastenki.
English: In particular, tell your doctor if you are taking anything in this list or any other medicines: - some medicines to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole and voriconazole) - some medicines to treat pain (e.g. mefenamic acid, diflunisal, and niflumic acid) - some medicines to treat bacterial infections (e.g. rifampicin, clarithromycin, telithromycin) - medicines typically used to treat epilepsy (seizures) (e.g. phenytoin, carbamazepine or phenobarbital) - methotrexate, a medicine typically used to treat cancer - rosuvastatin, fluvastatin, atorvastatin, medicines typically used to treat high cholesterol - warfarin or phenprocoumon, medicines typically used to thin your blood - St. John's wort (medicine obtained also without a prescription), a herbal treatment for depression.
Slovenian: - nekatera zdravila za zdravljenje glivičnih okužb (npr. ketokonazol, itrakonazol, posakonazol in vorikonazol) - nekatera zdravila za lajšanje bolečin (npr. mefenaminska kislina, diflunizal in niflumska kislina) - nekatera zdravila za zdravljenje bakterijskih okužb (npr. rifampicin, klaritromicin, telitromicin) - zdravila, ki se običajno uporabljajo za zdravljenje epilepsije (epileptičnih napadov) (npr.
English: TSH post baseline >4 times ULN was reported in 6.5% of patients treated with Stivarga and in 1.3% of patients receiving placebo.
Slovenian: Poročali so, da je bil TSH glede na izhodiščno vrednost več kot štirikrat večji od zgornje normalne vrednosti pri 6,5 % bolnikov, zdravljenih z zdravilom Stivarga, in 1,3 % bolnikov, ki so prejemali placebo.
English: The addition of Stivarga to BSC resulted in significantly longer survival, compared to placebo plus BSC with a p value of 0.005178 from stratified log rank test, a hazard ratio of 0.774 [95% CI 0.636, 0.942] ) and a median OS of 6.4 months vs. 5.0 months (see Table 5 and Figure 1).
Slovenian: Zdravljenje z zdravilom Stivarga in najboljša podporna oskrba sta pomembno podaljšala preživetje v primerjavi s placebom in najboljšo podporno oskrbo (p = 0,005178 stratificiran log-rank test), razmerjem ogroženosti 0,774 [95 % IZ 0,636; 0,942]) in mediano celokupnega preživetja 6,4 mesecev v primerjavi s 5,0 (glejte preglednico 5 in sliko 1).
English: Figure 4: Kaplan-Meier curve of OS
Slovenian: Slika 4: Kaplan-Meierjeva krivulja celokupnega preživetja
English: Hypokalaemia Hypophosphatemia Hypocalcaemia Hyponatraemia Hypomagnesaemia Hyperuricaemia Dehydration
Slovenian: Presnovne in prehranske motnje zmanjšan apetit in vnos hrane hipokaliemija hipofosfatemija hipokalciemija hiponatriemija hipomagneziemija hiperurikemija dehidracija
English: Stivarga 40 mg film-coated tablets.
Slovenian: IME ZDRAVILA Stivarga 40 mg filmsko obložene tablete
English: - metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies.
Slovenian: Zdravilo Stivarga je indicirano kot monoterapija za zdravljenje odraslih bolnikov z: - metastatskim kolorektalnim rakom, ki so bili predhodno že zdravljeni ali niso primerni za zdravljenja, ki so na voljo.
English: and fits (hypertensive crisis) - inflammation of the pancreas characterized by pain in the area of the stomach, nausea,
Slovenian: - vnetje trebušne slinavke, ki se kaže kot bolečina v predelu trebuha, občutek siljenja na bruhanje,
English: No dosage adjustment is necessary if you have a mildly impaired liver function.
Slovenian: Pri blagi okvari jeter odmerka ni treba prilagajati.
English: Myocardial infarction Myocardial ischaemia
Slovenian: Srčne bolezni miokardni infarkt miokardna ishemija
English: Pack of 84 (3 bottles of 28) film-coated tablets.
Slovenian: Velikosti pakiranj pakiranje z 28 filmsko obloženimi tabletami pakiranje s 84 (3 plastenke z 28) filmsko obloženimi tabletami Na trgu morda ni vseh navedenih pakiranj.
English: Not known (frequency cannot be estimated from the available data)
Slovenian: Neznana pogostnost polipi)
English: Liver problems
Slovenian: Okvare jeter
English: Diarrhoea Stomatitis Vomiting Nausea
Slovenian: Gastro intestinalna fistula pankreatitis
English: Stivarga has been associated with an increased incidence of haemorrhagic events, some of which were fatal (see section 4.8).
Slovenian: Zdravilo Stivarga je povezano s povečano incidenco krvavitev, od katerih so bile nekatere smrtne (glejte poglavje 4.8).
English: - if you recently had, or are going to have, a surgical procedure Stivarga might affect the way your wounds heal and treatment may need to be stopped until your wound have healed.
Slovenian: Zdravilo Stivarga lahko vpliva na celjenje ran, zato bo morda treba prekiniti zdravljenje, dokler se rana ne zaceli.
English: Dermatological toxicity
Slovenian: Stopnja kožne toksičnosti
English: Package Leaflet: Information for the user Stivarga 40 mg film-coated tablets regorafenib
Slovenian: Navodilo za uporabo Stivarga 40 mg filmsko obložene tablete regorafenib
English: The primary efficacy endpoint was OS.
Slovenian: Primarni cilj učinkovitosti je bilo celokupno preživetje.
English: Hypersensitivity reaction
Slovenian: Bolezni imunskega sistema preobčutljivostn a reakcija
English: Laboratory test abnormalities
Slovenian: Odstopanja v izvidih laboratorijskih preiskav
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Sušilno sredstvo pustite v plastenki.
English: (NASH, 7%)
Slovenian: nealkoholnim steatohepatitisom (NASH, 7 %)
English: How to store Stivarga
Slovenian: Shranjevanje zdravila Stivarga
English: Placebo plus BSC§ (N=194)
Slovenian: placebo in najboljša podporna oskrba § (N = 194)
English: Continue Stivarga treatment.
Slovenian: Nadaljevanje zdravljenja z zdravilom Stivarga.
English: Figure 3: Kaplan-Meier curves of OS
Slovenian: Slika 3: Kaplan-Meierjeva krivulja celokupnega preživetja meseci od randomizacije
English: Bayer S.p.A. Tel: +39-02-397 81
Slovenian: Tel: +39-02-397 81
English: Ask your doctor for advice before taking Stivarga.
Slovenian: Pred začetkom jemanja zdravila Stivarga se posvetujte z zdravnikom.
English: Dose interruption or reduction, or permanent discontinuation of Stivarga should be considered in case of persistent or recurrent significant abnormalities (see section 4.2).
Slovenian: Pri dolgotrajnih ali ponavljajočih se pomembnih odstopanjih od normalnih vrednosti se priporoča prekinitev zdravljenja, zmanjšanje odmerka ali trajno prenehanje zdravljenja z zdravilom Stivarga (glejte poglavje 4.2).
English: - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) - razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij)
English: Stivarga plus BSC (n= 500)
Slovenian: Stivarga in najboljša podporna oskrba (N = 500)
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Haemorrhage* Hypertension
Slovenian: (navzea), bruhanje in krče (hipertenzivna kriza)
English: Gastrointestinal perforation* Gastrointestinal fistula Pancreatitis
Slovenian: Gastro intestinalna perforacija*
English: Leucopenia
Slovenian: Dojenje
English: Pain
Slovenian: SN
English: Common side effects (may affect up to 1 in 10 users)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Genotoxicity and carcinogenicity
Slovenian: Mehanizem delovanja in farmakodinamični učinki
English: 0.9 months
Slovenian: 0,9 mesecev celokupno preživetje
English: Co-administration with neomycin, a poorly absorbed antimicrobial agent used for eradicating the gastrointestinal microflora (which may interfere with the enterohepatic circulation of regorafenib) had no effect on the regorafenib exposure, but there was an approximately 80% decrease in the exposure of the active metabolites M-2 and M-5 which showed in vitro and in vivo comparable pharmacological activity as regorafenib.
Slovenian: Sočasna uporaba z neomicinom, protimikrobno učinkovino, za katero je značilna slaba absorpcija in se uporablja za uničenje črevesne mikroflore (kar lahko vpliva na regorafenib v enterohepatičnem obtoku), ni vplivala na izpostavljenost regorafenibu.
English: Figure 2: Kaplan-Meier curves of PFS
Slovenian: Slika 2: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni
English: These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)
Slovenian: Ta vključujejo kemoterapijo na osnovi fluoropirimidina, zdravljenje z zaviralci VEGF in zdravljenje z zaviralci EGFR (glejte poglavje 5.1); - neoperabilnimi ali metastatskimi gastrointestinalnimi stromalnimi tumorji (GIST), pri katerih je bolezen napredovala ali niso prenašali predhodnega zdravljenja z imatinibom in sunitinibom; - rakom jetrnih celic (hepatocelularni karcinom - HCC), ki so bili predhodno zdravljeni s sorafenibom.
English: Rydapt midostaurin
Slovenian: Rydapt midostavrin
English: About 51% of those given Rydapt and 43% of those given placebo were still alive after 5 years.
Slovenian: Približno 51 % bolnikov, ki so prejemali zdravilo Rydapt, in 43 % tistih, ki so prejemali placebo, je bilo po 5 letih še vedno živih.
English: What measures are being taken to ensure the safe and effective use of Rydapt?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rydapt?
English: The full EPAR for Rydapt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rydapt je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Overall, using the most stringent, up-to-date criteria, the disease responded to treatment in about 28% of patients (32 of 113).
Slovenian: Ob uporabi najstrožjih in najnovejših kriterijev se je bolezen skupno odzvala na zdravljenje pri približno 28 % (32 od 113) bolnikov.
English: This is a summary of the European public assessment report (EPAR) for Rydapt.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rydapt.
English: It is not intended to provide practical advice on how to use Rydapt.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The safety of the medicine was acceptable in such a severe condition and was considered manageable.
Slovenian: Pri tako hudi bolezni je bila varnost zdravila sprejemljiva in ocenjena kot obvladljiva.
English: Other information about Rydapt
Slovenian: Druge informacije o zdravilu Rydapt
English: The company that markets Rydapt will complete three further studies to provide the Agency with evidence to support the effectiveness of the medicine in elderly patients with AML.
Slovenian: Družba, ki trži zdravilo Rydapt, bo izvedla še tri študije in agenciji predložila dokaze v podporo učinkovitosti zdravila pri starejših bolnikih z AML.
English: What is Rydapt and what is it used for?
Slovenian: Kaj je zdravilo Rydapt in za kaj se uporablja?
English: When looked at separately the response rate was highest (60%) in those with aggressive systemic mastocytosis.
Slovenian: Ob ločeni obravnavi bolezni je bila stopnja odziva najvišja (60 %) pri bolnikih z agresivno sistemsko mastocitozo.
English: Treatment is continued for up to 12 cycles depending on how patients respond.
Slovenian: Zdravljenje traja do 12 ciklov, odvisno od bolnikovega odziva.
English: If a patient develops certain severe side effects, the doctor may decide to reduce subsequent doses or delay or stop treatment.
Slovenian: Če se pri bolniku pojavijo določeni resni neželeni učinki, se lahko zdravnik odloči za zmanjšanje nadaljnjih odmerkov, za odložitev ali ukinitev zdravljenja.