natgillin/translations-raw huggingface dataset:
The patient alert card will be integrated in the packaging and the content will be agreed as part of the labelling (Annex III).
Opozorilna kartica za bolnika bo vključena v pakiranje, vsebina pa bo dogovorjena kot del označevanja (Priloga III).
The demographic and baseline characteristics were well-balanced between the two treatment arms.
Demografske in izhodiščne lastnosti so bile med obema skupinama zdravljenja dobro uravnotežene.
My name: ________________________________________________________________________ My contact number: ____________________________________________________________ Emergency contact: ________________________________________________________________ Emergency contact number: ________________________________________________________ Name of Haematologist/Oncologist/Oncology Nurse: _____________________________________ Contact number: _______________________________________________________________ After-hours contact number: _____________________________________________________ Name of my Hospital: ______________________________________________________________ My Hospital contact number: ____________________________________________________
Ime bolnika: _______________________________________________________________________ Telefonska številka bolnika:__________________________________________________________ Stik za nujne primere: ______________________________________________________________ Telefonska številka za nujne primere:__________________________________________________ Ime hematologa/onkologa/medicinske sestre na oddelku: _________________________________ Telefonska številka zdravnika/medicinske sestre:________________________________________ Telefonska številka izven rednega delovnega časa:_______________________________________ Naziv bolnišnice: ___________________________________________________________________ Telefonska številka bolnišnice:________________________________________________________
Efficacy and safety was evaluated in the active-controlled, phase 3 study (2215-CL-0301) .
Učinkovitost in varnost sta bili ovrednoteni v okviru študije 3. faze, kontrolirane z učinkovino (2215-CL-0301).
None of these three metabolites exceeded 10% of overall parent exposure.
Noben od teh treh presnovkov ni presegel 10 % skupne izpostavljenosti starševske spojine.
The safety and efficacy of Xospata in children aged below 18 years has not yet been established.
Varnost in učinkovitost zdravila Xospata pri otrocih, mlajših od 18 let, še nista bili dokazani.
In the study 42% of patients were 65 years or older and 12% were 75 years or older.
V študiji je bilo 42 % bolnikov starih 65 let ali več, 12 % pa jih je bilo starih 75 let ali več.
• Carry this card with you at all times, especially when you travel or when you see another doctor.
• To kartico imejte vedno pri sebi, zlasti ko potujete ali obiščete drugega zdravnika.
- Swallow the tablets whole with water.
- Tablete pogoltnite cele skupaj z vodo.
A risk to the breast-fed children cannot be excluded.
Tveganja za dojene otroke ni mogoče izločiti.
IMPORTANT INFORMATION FOR HEALTHCARE PROVIDERS
POMEMBNE INFORMACIJE ZA ZDRAVSTVENE DELAVCE
Figure 1: Kaplan-Meier plot of overall survival in ADMIRAL study
Slika 1: Kaplan-Meierjev diagram celokupnega preživetja v študiji ADMIRAL
Reversibility of most of the changes was indicated by the end of the 4-week recovery period.
Ob koncu 4-tedenskega obdobja okrevanja je bila večina sprememb reverzibilnih.
b. The 95% CI rate was calculated using the exact method based on binomial distribution.
Raven 95-odstotnega IZ se je izračunala z natančno metodo na podlagi binominalne distribucije.
You will also find this information in the Patient Alert Card that is included in the packaging.
Te informacije boste našli tudi na opozorilni kartici bolnika, ki je priložena pakiranju.
ADMIRAL study (2215-CL-0301)
Študija ADMIRAL (2215-CL-0301)
Patients who develop signs and symptoms suggestive of pancreatitis should be evaluated and monitored.
Stanje bolnikov, pri katerih se razvijejo znaki in simptomi, ki kažejo na pankreatitis, je treba ovrednotiti in spremljati.
Frequency categories are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene tako: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
These changes were observed at plasma exposure levels similar to or less than clinical exposure levels.
Te spremembe so opažali ob ravneh izpostavljenosti v plazmi, ki so bile podobne ali manjše od ravni klinične izpostavljenosti.
Do not give Xospata to children and adolescents under 18 years because it is not known whether it is safe and effective in this age group.
Zdravila Xospata ne dajajte otrokom in mladostnikom, mlajšim od 18 let, ker ni znano, ali je zdravilo za to starostno skupino varno in učinkovito.
Your doctor will also regularly check your heart function before and during treatment.
Zdravnik bo pred in med zdravljenjem tudi redno preverjal delovanje vašega srca.
Approximately 16.4% of the total dose was excreted in urine as unchanged drug and metabolites.
Približno 16,4 % skupnega odmerka se je izločilo z urinom v obliki nespremenjenega zdravila in presnovkov.
Your doctor will tell you what dose of Xospata to take.
Zdravnik vam bo povedal, kakšen odmerek zdravila Xospata morate jemati.
Response may be delayed; therefore, continuation of treatment at the prescribed dose for up to 6 months should be considered to allow time for a clinical response.
Odziv je lahko zakasnel, zato pride v poštev nadaljevanje zdravljenja v predpisanem odmerku še do 6 mesecev, da lahko pride do kliničnega odziva.
There have been reports of pancreatitis.
Poročali so o pankreatitisu.
CHRYSALIS study (2215-CL-0101)
Študija CHRYSALIS (2215-CL-0101)
The tablets can be taken with or without food.
Tablete se lahko jemljejo skupaj s hrano ali brez nje.
Chemotherapy (N=124)
Kemoterapija (N = 124)
Some cases had concomitant acute febrile neutrophilic dermatosis.
V nekaterih primerih je hkrati prišlo do akutne febrilne nevtrofilne dermatoze.
Dose reductions were allowed, to manage adverse reactions, and dose increases were allowed, for those patients who did not respond at the starting dose of 120 mg.
Zmanjšanje odmerka je bilo dovoljeno za obvladovanje neželenih učinkov, povečanje odmerka pa je bilo dovoljeno za tiste bolnike, ki se niso odzvali na začetni odmerek 120 mg.
However, the predicted increase on gilteritinib exposure was less than 2-fold.
Vendar pa je bilo predvideno povečanje izpostavljenosti gilteritinibu manj kot 2kratno.
Treatment with Xospata should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
Zdravljenje z zdravilom Xospata mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo terapij za zdravljenje raka.
It is not known if Xospata passes into your breast milk and could harm your baby.
Ni znano, ali zdravilo Xospata prehaja v materino mleko in ali lahko škoduje otroku.
Embryofoetal toxicity and contraception
Embrio-fetalna toksičnost in kontracepcija
These may be signs of an inflammation of the pancreas (pancreatitis).
To so lahko znaki vnetja trebušne slinavke (pankreatitisa).
In the event of an overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic and supportive treatment initiated, taking into consideration the long half-life estimated at 113 hours.
V primeru prevelikega odmerjanja je treba bolnike pozorno spremljati, če se pokažejo znaki ali simptomi neželenih učinkov, ter uvesti ustrezno simptomatsko in podporno zdravljenje, pri čemer je treba upoštevati dolg razpolovni čas, ki je ocenjen na 113 ur.
It is unknown whether gilteritinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.
Ni znano, ali lahko gilteritinib zmanjša učinkovitost hormonskih kontraceptivov, zato morajo ženske, ki uporabljajo hormonske kontraceptive, hkrati uporabljati še pregradno metodo kontracepcije.
If PRES is suspected, it should be confirmed by brain imaging, preferably magnetic resonance imaging (MRI).
V primeru suma na PRES je treba to stanje potrditi s slikanjem možganov, najbolje z magnetno resonanco (MRI).
5HT2B receptor or sigma nonspecific receptor
Receptor 5HT2B ali nespecifični receptor sigma
QT prolongation can be observed in the first two months of treatment with gilteritinib.
Podaljšanje intervala QT je mogoče opaziti v prvih dveh mesecih zdravljenja z gilteritinibom.
There is no known specific antidote for Xospata.
Za zdravilo Xospata ne obstaja specifični antidot.
Your doctor may do a test to check if you have developed PRES and will stop Xospata treatment if it is confirmed that you have PRES.
Zdravnik lahko s preiskavo preveri, ali se je pri vas razvil PRES, in ustavi zdravljenje z zdravilom Xospata, če potrdi, da imate PRES.
If you use a hormonal contraceptive, you must also use a barrier method, such as a condom or a diaphragm.
Če uporabljate hormonske kontraceptive, morate hkrati uporabljati še pregradno metodo kontracepcije, kot je kondom ali diafragma.
OPA/aluminium/PVC/aluminium blisters containing 21 film-coated tablets.
Pretisni omoti OPA/aluminij/PVC/aluminij, ki vsebujejo po 21 filmsko obloženih tablet.
- Contact details of the treating physician who has prescribed Xospata.
- Kontaktni podatki lečečega zdravnika, ki je predpisal zdravilo Xospata.
The majority of patients (83.8%) had an ECOG performance status score of 0 or 1.
Večina bolnikov (83,8 %) je imela oceno stanja zmogljivosti 0 ali 1 po lestvici ECOG.
The primary metabolites in humans include M17 (formed via N-dealkylation and oxidation), M16 and M10 (both formed via N-dealkylation) and were observed in animals.
Primarni presnovki pri ljudeh vključujejo M17 (tvori se z N-dealkilacijo in oksidacijo), M16 in M10 (oba se tvorita z N-dealkilacijo) in so bili opaženi pri živalih.
Gilteritinib has minor influence on the ability to drive and use machines.
Gilteritinib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
The decision to re-introduce gilteritinib treatment after an event of QT prolongation should be based on a careful consideration of benefits and risks.
Pri odločanju o ponovni uvedbi zdravljenja z gilteritinibom po pojavu podaljšanega intervala QT je treba skrbno pretehtati koristi in tveganja.
The effect of mild or moderate renal impairment was evaluated using a population pharmacokinetic model.
Učinek blage ali zmerne okvare so ovrednotili s populacijskim farmakokinetičnim modelom.
Talk to your doctor, pharmacist or nurse immediately if you have any of the following symptoms:
Nemudoma se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate katerega od naslednjih simptomov:
The primary efficacy endpoint for the final analysis was OS in the intent-to-treat (ITT) population, measured from the date of randomisation until death by any cause (number of events analysed was 261).
Primarni opazovani dogodek učinkovitosti za končno analizo je bilo celokupno preživetje (OSoverall survival) pri populaciji z namenom zdravljenja (ITT - intent-to-treat), merjeno od datuma randomizacije do smrti iz katerega koli vzroka (število analiziranih dogodkov je bilo 261).
• This patient is being treated with Xospata (gilteritinib), which can cause differentiation syndrome.
• Ta bolnik se zdravi z zdravilom Xospata (gilteritinib), ki lahko povzroči sindrom diferenciacije.
Treatment should continue until the patient is no longer clinically benefiting from Xospata or until unacceptable toxicity occurs.
Zdravljenje se mora nadaljevati, dokler bolnik od uporabe zdravila Xospata nima več kliničnih koristi ali dokler ne pride do nedopustne toksičnosti.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
Continue treatment at the dose prescribed by your doctor.
Nadaljujte zdravljenje z odmerkom, ki vam ga je predpisal zdravnik.
MEC and FLAG-Ida were given for up to two cycles depending on response to first cycle.
Zdravljenji z MEC in FLAG-Ida sta se glede na odziv v prvem ciklu izvajali največ dva cikla.
Efficacy was further supported by the rate of complete remission (CR)/complete remission with partial haematologic recovery (CRh) (Table 3, Figure 1).
Učinkovitost sta še nadaljnje podpirali stopnja popolne remisije (CR - complete remission)/popolne remisije z delnim hematološkim okrevanjem (CRh - complete remission with partial haematologic recovery) (preglednica 4, slika 1).
QTc interval >500 msec
Interval QTc > 500 milisekund
Juvenile animal toxicity study
Študija toksičnosti pri živalskih mladičih
Twelve percent of patients received previous treatment with another FLT3 inhibitor.
12 % bolnikov se je predhodno zdravilo z drugim zaviralcem receptorja FLT3.
The tablets are provided in blisters and are available in packs containing 84 film-coated tablets (4-blisters of 21 film-coated tablets).
Tablete so pakirane v pretisnih omotih in so na voljo v pakiranjih, ki vsebujejo 84 filmsko obloženih tablet (4 pretisni omoti s po 21 filmsko obloženimi tabletami).
Xospata may affect the way these medicines work, or these medicines may affect how Xospata works.
Zdravilo Xospata lahko vpliva na delovanje drugih zdravil ali pa lahko druga zdravila vplivajo na delovanje zdravila Xospata.
Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment.
Simptomi sindroma diferenciacije se lahko pri predčasni ustavitvi zdravljenja s kortikosteroidi ponovijo.
Avoid concomitant use of these medicinal products with Xospata unless use is considered essential for the care of the patient.
Izogibajte se hkratni uporabi teh zdravil z zdravilom Xospata, razen če je njihova uporaba bistvena za oskrbo bolnika.
Adverse reactions observed during clinical studies are listed below by frequency category.
Neželeni učinki, opaženi med kliničnimi študijami, so glede na kategorijo pogostnosti navedeni spodaj.
Gilteritinib blocks the action of certain enzymes (kinases) needed for the abnormal cells to multiply and grow, thus preventing the growth of the cancer.
Gilteritinib zavira delovanje določenih encimov (kinaz), ki so potrebni za razmnoževanje in rast abnormalnih celic, ter s tem prepreči širjenje raka.
The estimated apparent clearance (CL/F) based on the population PK model is 14.85 L/h.
Ocenjeni navidezni očistek (CL/F) na podlagi populacijske farmakokinetične analize je 14,85 l/h.
Fertility There are no data on the effect of gilterinitib on human fertility.
Plodnost Ni podatkov o učinku gilterinitiba na plodnost ljudi.
• Interrupt treatment with gilteritinib one week prior to administration of the conditioning regimen for HSCT.
• Zdravljenje z gilteritinibom prekinite en teden pred uporabo sheme priprave za PKMC.
Adverse reactions not observed in clinical studies, but seen in animals (safety pharmacology/repeat dose toxicity) at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Neželeni učinki, ki jih v kliničnih študijah niso opazili, opazili pa so jih v študijah na živalih (farmakološka varnost/toksičnost pri ponavljajočih odmerkih) pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti, in so morda pomembni za klinično uporabo, so naslednji:
Patients had the following confirmed mutations: FLT3-ITD alone (88.4%), FLT3-TKD alone (8.4%) or both FLT3-ITD and FLT3-TKD (1.9%).
Pri bolnikih so bile potrjene naslednje mutacije: samo FLT3-ITD (88,4 %), samo FLT3-TKD (8,4 %) ali FLT3-ITD in FLT3-TKD skupaj (1,9 %).
Xospata is not recommended for use in patients with severe (Child-Pugh Class C) hepatic impairment, as safety and efficacy have not been evaluated in this population (see section 5.2).
Zdravljenje z zdravilom Xospata ni priporočeno pri bolnikih s hudo (Child-Pugh razred C) okvaro jeter, ker varnost in učinkovitost za to populacijo nista bili ocenjeni (glejte poglavje 5.2).
Xospata should be administered at about the same time each day.
Zdravilo Xospata je treba aplicirati vsak dan ob približno istem času.
The safety of Xospata was evaluated in 319 patients with relapsed or refractory AML who have received at least one dose of 120 mg gilteritinib.
Varnost zdravila Xospata so ovrednotili na podlagi 319 bolnikov s ponovljeno ali neodzivno AML, ki so prejeli vsaj en odmerek 120 mg gilteritiniba.
Of the 11 patients who experienced differentiation syndrome, 9 (82%) recovered after treatment or after dose interruption of Xospata.
Od 11 bolnikov, pri katerih je prišlo do sindroma diferenciacije, si je 9 (82 %) bolnikov po zdravljenju ali po prekinitvi odmerjanja zdravila Xospata opomoglo.
Gilteritinib has been associated with differentiation syndrome (see section 4.8).
Gilteritinib je povezan s sindromom diferenciacije (glejte poglavje 4.8).
The recommended dose is 120 mg (three tablets) once a day.
Priporočeni odmerek je 120 mg (tri tablete) enkrat na dan.
If you normally take any of these medicines, your doctor might change it and prescribe a different medicine for you during your treatment with Xospata.
Če običajno jemljete katero koli od teh zdravil, vam ga zdravnik lahko zamenja in predpiše drugo zdravilo, dokler se zdravite z zdravilom Xospata.
Pregnant women should be informed of the potential risk to a foetus (see sections 4.6 and 5.3).
Nosečnice je treba obvestiti o morebitnem tveganju za plod (glejte poglavji 4.6 in 5.3).
Sixteen patients were randomised but not treated in the study (1 patient in the gilteritinib arm and 15 patients in the chemotherapy arm).
Šestnajst bolnikov je bilo randomiziranih, vendar se v študiji niso zdravili (1 bolnik v skupini zdravljenja z gilteritinibom in 15 bolnikov v skupini zdravljenja s kemoterapijo).
For recommendations in case of suspected differentiation syndrome see sections 4.2 and 4.4.
Za priporočila v primeru suma na sindrom diferenciacije glejte poglavji 4.2 in 4.4.
Other Grade 3a or higher toxicity considered related to treatment.
Druge toksičnosti 3. stopnje a ali višje stopnje resnosti, ki so povezane z zdravljenjem.
Gilteritinib did not induce gene mutation or chromosomal aberrations in vitro.
Gilteritinib ni induciral genskih mutacij ali kromosomskih nepravilnosti in vitro.
The educational material is aimed at haematologists who treat patients with leukemias including AML, and patients with AML prescribed Xospata to further inform prescribers and patients regarding the important identified risk of differentiation syndrome.
Izobraževalno gradivo je namenjeno hematologom, ki zdravijo bolnike z levkemijami, vključno z AML, in bolnikom z AML, ki jim je predpisano zdravilo Xospata, in sicer za dodatno seznanjanje zdravnikov, ki predpisujejo zdravilo, in bolnikov o pomembnem ugotovljenem tveganju za sindrom diferenciacije.
In the juvenile toxicity study in rats, the minimum lethal dose level (2.5 mg/kg/day) was much lower than that of adult rats (20 mg/kg/day).
V študiji toksičnosti pri mladičih podgan, je bil najmanjši smrtni odmerek (2,5 mg/kg/dan), veliko manši kot pri odraslih podganah (20 mg/kg/dan).
• Treatment can be resumed 30 days after HSCT if engraftment was successful, the patient did not have grade ≥2 acute graft versus host disease and was in CRc.c a. Grade 1 is mild, Grade 2 is moderate, Grade 3 is serious, Grade 4 is life-threatening.
• Zdravljenje se lahko nadaljuje 30 dni po PKMC, če je bila presaditev uspešna ni prišlo do akutne reakcije presadka proti gostitelju ≥ 2. stopnje in je bila dosežena CRc c. a. 1. stopnja resnosti je blaga, 2. stopnja je zmerna, 3. stopnja je huda, 4. stopnja pa smrtno nevarna.
Median tmax was delayed 2 hours when gilteritinib was administered with a high-fat meal.
Mediana vrednosti tmax se je zamaknila za 2 uri, ko je bil gilteritinib apliciran z obrokom z visoko vsebnostjo maščob.
In the absence of a response (patient did not achieve a CRc) after 4 weeks of treatment, the dose can be increased to 200 mg (five 40 mg tablets) once daily, if tolerated or clinically warranted.
Če po 4 tednih zdravljenja ni odziva (bolnik ni dosegel CRc), je odmerek mogoče povečati na 200 mg (pet 40 mg tablet) enkrat na dan, če bolnik to prenese in če je klinično upravičeno.
Complete remission
Popolna remisija
Your doctor may decide to increase or lower your dose or temporarily interrupt treatment.
Zdravnik se lahko odloči za povečanje ali zmanjšanje odmerka, lahko pa zdravljenje tudi začasno prekine.
• Patient alert card o Patient alert card: - Information for patients that Xospata treatment may cause differentiation syndrome.
• Opozorilna kartica za bolnika o Opozorilna kartica za bolnika: - Informacije za bolnike, da lahko zdravljenje z zdravilom Xospata povzroči sindrom diferenciacije.
EU/1/19/1399/001 84 film coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1399/001 84 filmsko obloženih tablet
In vivo plasma protein binding in humans is approximately 90% and gilteritinib is primarily bound to albumin.
Pri ljudeh je in vivo vezava na beljakovine v plazmi približno 90 %, gilteritinib pa se primarno veže na albumin.
Blood chemistries, including creatine phosphokinase, should be assessed prior to initiation of treatment, on day 15 and monthly for the duration of treatment.
Krvne preiskave kemijskih parametrov, vključno s kreatin fosfokinazo, je treba oceniti pred začetkom zdravljenja, na 15. dan in nato vsak mesec med zdravljenjem.
Prior to the launch of Xospata in each Member State the MAH must agree about the content and format of the physician educational material, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila Xospata na trg v posamezni državi članici se mora imetnik dovoljenja za promet z s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva za zdravnike, vključno s sredstvi obveščanja, načini razdeljevanja in morebitnimi drugimi vidiki programa.
Round, light yellow film-coated tablet, debossed with the company logo and ‘235' on the same side.
Okrogla, svetlo rumena filmsko obložena tableta z vtisnjenim logotipom podjetja in številko „235“ na isti strani.
The median OS was 9.3 months for patients receiving gilteritinib and 5.6 months for those receiving chemotherapy.
Mediana celokupnega preživetja je bila 9,3 meseca pri bolnikih, ki so prejemali gilteritinib, in 5,6 meseca pri bolnikih, ki so prejemali kemoterapijo.
Xospata may harm your unborn baby and should not be used during pregnancy.
Zdravilo Xospata lahko škoduje nerojenemu otroku, zato ga med nosečnostjo ne smete jemati.
- Xospata can be taken with or without food.
- Zdravilo Xospata se lahko jemlje skupaj s hrano ali brez.
Xospata is used if AML is linked to an alteration of a gene called FLT3, and is given to patients whose disease has come back or has not improved after previous treatment.
Zdravilo Xospata se uporablja, če je AML povezana s spremembo gena FLT3, daje pa se bolnikom, pri katerih se je bolezen ponovno pojavila ali se stanje ni izboljšalo s prejšnjimi zdravljenji.
Other clinically significant serious adverse reactions included differentiation syndrome (2.2%), electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.6%).
Drugi klinično pomembni resni neželeni učinki so vključevali sindrom diferenciacije (2,2 %), podaljšan interval QT, izmerjen z elektrokardiogramom (0,9 %), in sindrom posteriorne reverzibilne encefalopatije (0,6 %).
The effect of severe renal impairment on gilteritinib exposure has not been investigated (see section 4.2).
Učinek hude okvare ledvic na izpostavljenost gilteritinibu še ni bil preučen (glejte poglavje 4.2).