natgillin/translations-raw huggingface dataset:
This is a summary of the European public assessment report (EPAR) for Xaluprine.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xaluprine.
The Committee considered that an oral suspension allows more accurate dosing and is more convenient for children unable to swallow tablets.
Odbor je menil, da peroralna suspenzija omogoča točnejše odmerjanje in je primernejša za otroke, ki niso zmožni pogoltniti tablet.
Because 6-mercaptopurine has been used for the treatment of ALL in the European Union for a number of years in the tablet form, the company presented results from the scientific literature of studies previously carried out with mercaptopurine tablets.
Ker se 6-merkaptopurin v obliki tablet v Evropski uniji že vrsto let uporablja za zdravljenje ALL, je družba predstavila rezultate iz znanstvene literature, povezane s študijami, ki so jih izvedli s tabletam merkaptopurina.
The CHMP noted that mercaptopurine is established as an important treatment for ALL and that the only authorised form in the EU is a 50 mg tablet, making it difficult to adjust the dose for smaller children.
CHMP je ugotovil, da je merkaptopurin uveljavljen kot pomembno zdravilo za zdravljenje ALL in da je njegova edina odobrena oblika v EU 50 mg tableta, kar otežuje prilagajanje odmerka za manjše otroke.
It can be taken with food (except dairy products) or on an empty stomach but this should be consistent from day to day.
Zdravilo se lahko jemlje s hrano (razen mlečnih izdelkov) ali na tešče, vendar se morajo bolniki dosledno držati načina, ki si ga izberejo.
The Committee concluded that the benefits of Xaluprine are greater than its risks and recommended that it be granted marketing authorisation.
Odbor je zaključil, da so koristi zdravila Xaluprine večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Because the number of patients with ALL is low, the disease is considered ‘rare', and Xaluprine was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 April 2009.
Ker je bolnikov z ALL malo, velja ta bolezen za redko, zato je bilo zdravilo Xaluprine dne 30. aprila 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
For more information, see the summary of product characteristics (also part of the EPAR).
Več informacij najdete v povzetku glavnih značilnosti zdravila (ki je prav tako sestavni del EPAR).
6mercaptopurine prevents them from dividing and they eventually die, thereby slowing down the progression of the leukaemia.
6-merkaptopurin limfocitom prepreči delitev, zato ti sčasoma odmrejo, kar upočasni napredovanje levkemije.
The summary of the opinion of the Committee for Orphan Medicinal Products for Xaluprine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote za zdravilo Xaluprine je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
In the body, 6-mercaptopurine is converted within cells into a substance that interferes with the production of new DNA.
V telesu se 6-merkaptopurin znotraj celic pretvori v učinkovino, ki ovira nastanek nove DNK.
For more information about treatment with Xaluprine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xaluprine preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Xaluprine is a medicine that contains the active substance mercaptopurine.
Xaluprine je zdravilo, ki vsebuje zdravilno učinkovino merkaptopurin.
The active substance in this medicine, mercaptopurine has a similar chemical structure to purine, which is one of the fundamental chemicals that make up DNA.
Zdravilna učinkovina v tem zdravilu, merkaptopurin, ima podobno kemijsko zgradbo kot purin, ki je ena od osnovnih spojin, ki tvorijo DNK.
The bioavailability study showed that Xaluprine is comparable to the tablets, but it works in a more predictable way and has a higher rate of absorption, for which reason the dose will need to be adjusted when a patient switches from one formulation to the other.
Študija biološke uporabnosti je pokazala, da je zdravilo Xaluprine primerljivo s tabletami, vendar je njegovo delovanje bolj predvidljivo in ima višjo stopnjo absorpcije, zato je treba odmerek prilagoditi, kadar bolnik eno obliko zdravila zamenja z drugo.
Medicines containing mercaptopurine in tablet form have been already used in the EU for many years to treat patients with ALL.
Zdravila, ki vsebujejo merkaptopurin, se v obliki tablet za zdravljenje bolnikov z ALL v EU uporabljajo že vrsto let.
Xaluprine must not be used in people who are hypersensitive (allergic) to mercaptopurine or any of the other ingredients.
Zdravila Xaluprine ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) merkaptopurin ali katero koli drugo sestavino zdravila.
Xaluprine is used to treat children, adolescents and adults who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell).
Zdravilo Xaluprine se uporablja za zdravljenje otrok, mladostnikov in odraslih, ki imajo akutno limfoblastno levkemijo (ALL), tj. raka limfocitov (vrste belih krvnih celic).
What benefit has Xaluprine shown during the studies?
Kakšne koristi je zdravilo Xaluprine izkazalo med študijami?
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 Xaluprine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Xaluprine, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
A study was also carried out to compare the bioavailability of Xaluprine, which is an oral suspension, with that of the tablet.
Izvedena je bila tudi študija, kjer so primerjali biološko uporabnost zdravila Xaluprine, ki je peroralna suspenzija, z biološko uporabnostjo tablete.
The most common side effects with mercaptopurine (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts) and thrombocytopenia (low blood platelet counts).
Najpogostejši neželeni učinki merkaptopurina (opaženi pri več kot 1 bolniku od 10) so levkopenija (zmanjšano število belih krvnih celic) in trombocitopenija (zmanjšano število trombocitov).
The full EPAR for Xaluprine 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 Xaluprine je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The bioavailability study compared the way the two different forms of the same medicine are absorbed in the human body and the levels of the active substance they produce.
V študiji biološke uporabnosti so primerjali, kako človeško telo absorbira različni obliki istega zdravila, in koncentraciji zdravilne učinkovine, ki ju ti obliki dosežeta.
The added benefit of Xaluprine is that, as an oral suspension, it will provide more accuracy in dosing and it is easier to be taken by children.
Dodatna prednost zdravila Xaluprine je to, da ga bo možno kot peroralno suspenzijo točneje odmeriti in da ga bodo otroci lažje jemali.
Other information about Xaluprine
Druge informacije o zdravilu Xaluprine:
In ALL the lymphocytes multiply too quickly and live for too long.
Pri bolnikih z ALL se limfociti delijo prehitro in propadajo prepočasi.
What is the risk associated with Xaluprine?
Kakšna tveganja so povezana z zdravilom Xaluprine?
Why has Xaluprine been approved?
Zakaj je bilo zdravilo Xaluprine odobreno?
What is Xaluprine used for?
Za kaj se zdravilo Xaluprine uporablja?
How does Xaluprine work?
Kako zdravilo Xaluprine deluje?
How has Xaluprine been studied?
Kako je bilo zdravilo Xaluprine raziskano?
How is Xaluprine used?
Kako se zdravilo Xaluprine uporablja?
What is Xaluprine?
Kaj je zdravilo Xaluprine?
Date of first authorisation: 27 May 2015 Date of latest renewal:
Datum prve odobritve: 27. maj 2015 Datum zadnjega podaljšanja:
• feeling tired.
• občutek utrujenosti.
Therefore, use in these patients should be avoided.
Zato se je treba uporabi zdravila pri teh bolnikih izogibati.
Safety and efficacy were maintained throughout all cycles.
Varnost in učinkovitost sta se ohranili skozi celoten čas študije.
Dialysis studies have not been performed.
Študije dialize niso bile opravljene.
In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided.
V primeru prevelikega odmerjanja je treba zdravljenje z zdravilom ukiniti ter poskrbeti za splošno podporno zdravljenje in spremljanje.
Delayed phase
Zakasnjena faza
Women of childbearing potential/ contraception in females
Ženske v rodni dobi/kontracepcija pri ženskah
• rifampicin - to treat tuberculosis (TB) and other infections.
• rifampicin za zdravljenje tuberkuloze (TB) in drugih okužb.
These effects were not considered clinically important.
Teh učinkov niso ocenili kot klinično pomembne.
* p-value from Cochran-Mantel-Haenszel test, stratified by age class and region.
*Vrednost p iz Cochran-Mantel-Haenszelovega testa, statificirana po starostni kategoriji in regiji.
Akynzeo contains two medicines (‘active substances') called:
Zdravilo Akynzeo vsebuje dve zdravili (»učinkovini«), imenovani:
Elimination via both routes was estimated to be complete by Day 29-30 post-dose.
Ocenili so, da je izločanje prek obeh poti dokončano 29. do 30. dan po odmerjanju.
The effects were reversible or partially reversible after the recovery period.
Po obdobju okrevanja so bili učinki reverzibilni ali delno reverzibilni.
A total of 724 patients (99.9%) were treated with cyclophosphamide.
Skupno 724 bolnikov (99,9 %) je bilo zdravljenih s ciklofosfamidom.
There have also been reports of serotonin syndrome.
Poročali so tudi o serotoninskem sindromu.
The hard capsule should be swallowed whole.
Trdo kapsulo je treba pogoltniti celo.
Plasma concentrations followed a first order absorption process and reached Cmax in approximately 5 hours.
Plazemske koncentracije so sledile procesu absorpcije prvega reda in so dosegle Cmax v približno 5 urah.
You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects, you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
It can be taken with or without food.
Kapsulo je mogoče vzeti s hrano ali brez nje.
After completion of cycle 1, patients had the option to participate in a multiple-cycle extension, receiving the same treatment as assigned in cycle 1.
Po zaključku 1. cikla so bolniki imeli možnost sodelovanja v podaljšku z več cikli, v katerem bi prejemali enako zdravljenje kot v 1. ciklu.
Overall phase
Celotna faza
• sleep problems
• težave s spanjem,
• Take the capsule about 1 hour before you start your chemotherapy cycle.
• Vzemite kapsulo približno 1 uro pred začetkom cikla kemoterapije.
• lack of energy (feeling weak)
• izguba energije (občutek slabotnosti),
• you are allergic to netupitant or palonosetron, or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na netupitant ali palonosetron ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Since it may induce dizziness, somnolence or fatigue, patients should be cautioned not to drive or use machines if such symptoms occur.
Ker lahko povzročijo omotičnost, somnolenco ali utrujenost, je treba bolnike opozoriti, naj ne vozijo in naj ne upravljajo strojev, če se pojavijo tovrstni simptomi.
Approximately 62% of palonosetron is bound to plasma proteins.
Približno 62 % palonosetrona se veže na beljakovine v plazmi.
The AUC was 30% higher in cancer patients than in healthy subjects.
AUC je bila 30 % višja pri bolnikih z rakom kot pri zdravih osebah.
Hypokalaemia and hypomagnesaemia should be corrected prior to administration.
Hipokaliemijo in hipomagneziemijo je treba popraviti pred dajanjem zdravila.
If you are allergic to peanut or soya, see your doctor straight away if you notice any signs of an allergic reaction.
Če ste alergični na arašide ali sojo, takoj obiščite zdravnika, če opazite kakršen koli znak alergijske reakcije.
Absolute netupitant bioavailability data are not available in humans; based on data from two studies with intravenous netupitant, the bioavailability in humans is estimated to be greater than 60%.
Podatkov o absolutni biološki uporabnosti netupitanta pri ljudeh ni; na osnovi podatkov iz dveh študij z intravenskim netupitantom ocenjujejo, da je biološka uporabnost pri ljudeh večja od 60 %.
A summary of the key results from this study is shown in Table 3 below.
Povzetek ključnih rezultatov iz te študije je prikazan v spodnji preglednici 3.
There was no pre-specified limit of the number of repeat consecutive cycles for any patient.
Za nobenega bolnika ni bilo vnaprej določene omejitve številka ponovljenih zaporednih ciklov.
• You can take Akynzeo with or without food.
• Zdravilo Akynzeo lahko jemljete s hrano ali brez nje.
The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Vpliv navzee in bruhanja na vsakodnevno življenje bolnikov so ocenili z lestvico Functional Living Index-Emesis (FLIE).
It is not excluded that this effect may be more marked, and then clinically relevant, in cancer patients, notably those having abnormal renal function.
Ni izključeno, da je lahko ta pojav izrazitejši in s tem klinično pomemben pri bolnikih z rakom, še posebej tistih z nenormalnim delovanjem ledvic.
Of these, 1438 patients (98.8%) completed cycle 1 and 1286 patients (88.4%) continued treatment in the multiple-cycle extension.
Od teh je 1438 bolnikov (98,8 %) dokončalo 1. cikel in 1286 bolnikov (88,4 %) je nadaljevalo zdravljenje v podaljšku z več cikli.
In a population PK study, patients with a reduced creatinine clearance (CLCR) also had a reduced palonosetron clearance, but this reduction would not result in a significant change in palonosetron exposure.
V populacijski študiji FK so imeli bolniki z zmanjšanim očistkom kreatinina (CLCR) tudi zmanjšan očistek palonosetrona, vendar pa to zmanjšanje ni povzročilo znatne spremembe izpostavljenosti palonosetronu.
If you do not want to take Akynzeo, discuss this with your doctor.
Če zdravila Akynzeo ne želite jemati, se o tem posvetujte z zdravnikom.
Days 2 to 3
2. do 3. dan
The clinical relevance of this effect is not established.
Klinična pomembnost tega učinka ni bila ugotovljena.
One 300 mg/0.5 mg capsule should be administered approximately one hour prior to the start of each chemotherapy cycle.
Eno 300 mg/0,5 mg kapsulo je treba dati približno eno uro pred začetkom vsakega cikla kemoterapije.
Following oral administration, palonosetron is well absorbed with its absolute bioavailability reaching 97%.
Po peroralnem dajanju se palonosetron dobro absorbira, pri čemer njegova absolutna biološka uporabnost doseže 97 %.
All patients were additionally treated with either doxorubicin (68.0%) or epirubicin (32.0%).
Vsi bolniki so bili dodatno zdravljeni z doksorubicinom (68,0 %) ali epirubicinom (32,0 %).
Days 2 to 4
2. do 4. dan
Effect of ketoconazole and rifampicin
Učinek ketokonazola in rifampicina
Furthermore, the population PK study showed no correlation between PK parameters of netupitant and markers of renal dysfunction.
Poleg tega populacijska študija FK ni pokazala korelacije med FK parametri netupitanta in markerji disfunkcije ledvic.
Recent guidance has updated these regimens to highly emetogenic.
V nedavnih smernicah so bili tovrstni režimi uvrščeni med zelo emetogene.
A summary of the key results from this study is shown in Table below.
Povzetek ključnih rezultatov iz te študije je prikazan v spodnji preglednici.
The significance of these findings in humans is unknown.
Pomen teh ugotovitev za ljudi ni znan.
The safety and efficacy of Akynzeo capsules in the paediatric population have not been established.
Varnost in učinkovitost kapsul zdravila Akynzeo pri pediatrični populaciji nista bili dokazani.
Palonosetron has a volume of distribution of approximately 8.3 ± 2.5 L/kg.
Palonosetron ima volumen porazdelitve približno 8,3 ± 2,5 l/kg.
The underlying mechanisms are not fully understood, but because of the high doses employed and since the medicinal product is intended for single application in humans, these findings are not considered relevant for clinical use.
Mehanizmi v ozadju niso povsem razumljeni, vendar pa zaradi velikih odmerkov in dejstva, da je zdravilo namenjeno za enkratno uporabo pri človeku, te ugotovitve ne veljajo za relevantne za klinično uporabo.
If you think you have forgotten to take your dose, tell your doctor straight away.
Če mislite, da ste pozabili vzeti svoj odmerek, to takoj povejte zdravniku.
Stop taking Akynzeo and tell your doctor straight away if you notice the following serious side effectyou may need urgent medical treatment:
Nehajte jemati zdravilo Akynzeo in takoj povejte zdravniku, če opazite naslednji resni neželeni učinek, saj boste morda potrebovali nujno medicinsko pomoč:
Do not take Akynzeo if you are pregnant or if you are a woman of childbearing potential not using contraception.
Ne vzemite zdravila Akynzeo, če ste noseči ali ste ženska v rodni dobi in ne uporabljate kontracepcije.
If you think you may have taken more than you should, tell your doctor straight away.
Če mislite, da ste morda vzeli večji odmerek, kot bi smeli, to takoj povejte zdravniku.
No common adverse reactions are attributable to netupitant, the new component of the fixed combination.
Nobenega od pogostih neželenih učinkov ni mogoče pripisati netupitantu, ki je nova sestavina fiksne kombinacije.
The hard capsule is filled with three tablets and one soft capsule.
Trda kapsula vsebuje tri tablete in eno mehko kapsulo.
Erythromycin and Midazolam
Eritromicin in midazolam
Patients continued into the Multiple-Cycle extension for up to 7 additional cycles of chemotherapy.
Bolniki so nadaljevali zdravljenje v podaljšku z več cikli, in sicer do največ 7 dodatnih ciklov kemoterapije.
Akynzeo should not be taken by children and adolescents under 18 years.
Otroci in mladostniki, mlajši od 18 let, ne smejo jemati zdravila Akynzeo.
A total of 907 patients (62.3%) completed the multiple-cycle extension up to a maximum of eight treatment cycles.
Skupno 907 bolnikov (62,3 %) je dokončalo podaljšek z več cikli, in sicer z največ osmimi cikli zdravljenja.
Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Netupitant je selektiven antagonist človeških receptorjev snovi P/nevrokinina 1 (NK1).
Caution should be exercised when using this medicinal product in patients over 75 years, due to the long half-life of the active substances and the limited experience in this population.
Pri uporabi tega zdravila pri bolnikih, starejših od 75 let, je potrebna previdnost zaradi dolgega razpolovnega časa učinkovin in omejenih izkušenj s to populacijo.
• ring in the ear
• zvonjenje v ušesu,
However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolizers of CYP2D6 substrates.
Vendar pa se klinični farmakokinetični parametri pomembno ne razlikujejo med slabimi in dobrimi presnavljalci substratov CYP2D6.
• ketoconazole - to treat Cushing's syndrome
• ketokonazol za zdravljenje Cushingovega sindroma;
• erythromycin - to treat bacterial infections
• eritromicin za zdravljenje bakterijskih okužb;
1 hard capsule 4x1 hard capsules
1 trda kapsula 4 x1 trda kapsula
If you decide not to take Akynzeo (or another similar medicine), your chemotherapy is likely to make you feel sick and be sick.
Če se odločite, da zdravila Akynzeo (ali podobnega zdravila) ne boste jemali, bo kemoterapija pri vas verjetno povzročila občutek slabosti in bruhanje.
Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with this medicinal product.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še en mesec po njem.
A pregnancy test should be performed on all pre-menopausal women prior to treatment.
Pred začetkom zdravljenja je treba opraviti test nosečnosti pri vseh ženskah, ki še niso imele menopavze.
Therefore, caution is recommended when netupitant is combined with digoxin or with other P-gp substrates such as dabigatran, or colchicine.
Zato priporočamo previdnost pri kombiniranju netupitanta z digoksinom ali drugimi substrati P-gp, kot sta dabigatran ali kolhicin.
• high levels of certain enzymes, including blood alkaline phosphatase and liver transaminases
• visoke ravni določenih encimov, vključno z alkalno fosfatazo in jetrnimi transaminazami v krvi
EU/1/15/1001/001 1 hard capsule EU/1/15/1001/002 4x1 hard capsules
EU/1/15/1001/001 1 trda kapsula EU/1/15/1001/002 4 x 1 trda kapsula
When netupitant was administered on Day 8 of a 12-day regimen of digoxin, no changes in digoxin pharmacokinetics were observed.
Pri dajanju netupitanta 8. dan 12-dnevnega režima zdravljenja z digoksinom niso opazili sprememb farmakokinetike digoksina.
• sudden nervous breakdown, change in mood
• nenaden živčni zlom, sprememba razpoloženja;
The amount of unchanged palonosetron excreted in the urine represented approximately 40% of the administered dose.
Količina palonosetrona, ki se je nespremenjen izločil v urin, je predstavljala približno 40 % danega odmerka.
Women of childbearing potential should not be pregnant or become pregnant while on treatment with netupitant/palonosetron capsules.
Ženske v rodni dobi ne smejo biti noseče ali zanositi med zdravljenjem s kapsulami netupitanta in palonosetrona.
Post-marketing data indicates that the adverse reactions profile is generally similar to that seen in clinical trials.
Podatki v obdobju trženja zdravila kažejo, da je profil neželenih učinkov na splošno podoben tistemu v kliničnih preskušanjih.
Antiemetic activity of Akynzeo was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles.
Antiemetično delovanje zdravila Akynzeo se je ohranilo skozi ponovljene cikle pri bolnikih, ki so nadaljevali z vsakim od več dodatnih ciklov.
Marketing Authorisation Holder and Manufacturer:
Imetnik dovoljenja za promet z zdravilom in proizvajalec:
The ratios were time dependent with values decreasing gradually beyond 24 h post-dose, indicating that netupitant is being rapidly metabolized.
Razmerja so bila odvisna od časa in vrednosti so postopno upadale po 24 urah po odmerku, kar kaže na zelo hitro presnovo netupitanta.
All these reactions were uncommon.
Vsi ti učinki so bili občasni.
Multiple-cycle safety study in patients receiving either Highly Emetogenic Chemotherapy or Moderately Emetogenic Chemotherapy
Študija varnosti več ciklov pri bolnikih, ki so prejemali zelo emetogeno kemoterapijo ali zmerno emetogeno kemoterapijo
In single dose oral studies, netupitant was measurable in plasma between 15 minutes and 3 hours after dosing.
V študijah z enkratnim peroralnim odmerkom je bil netupitant merljiv v plazmi med 15 minutami in 3 urami po odmerjanju.
Chemotherapeutic substances produce nausea and vomiting by stimulating the release of serotonin from the enterochromaffin cells of the small intestine.
Kemoterapevtske snovi povzročajo navzeo in bruhanje prek stimulacije sproščanja serotonina iz enterokromafinih celic tankega črevesa.
This medicine contains sucrose, sorbitol, sodium and may contain soya - see section 2 for more information.
To zdravilo vsebuje saharozo, sorbitol, natrij ter lahko vsebuje sojo - za več informacij glejte poglavje 2.
Renal clearance is not a significant elimination route for netupitant-related entities.
Ledvični očistek ni pomembna pot izločanja za entitete, povezane z netupitantom.