FrancophonIA/ELRC3.0 huggingface dataset:
English: In humans, netupitant is eliminated mainly by hepatic metabolism mediated by CYP3A4 with a marginal renal excretion.
Slovenian: Pri ljudeh se netupitant večinoma izloča prek presnove v jetrih, ki jo posreduje CYP3A4, ledvično izločanje je zanemarljivo.
English: Rare (≥1/10,000 to <1/1,000),
Slovenian: Kategorije pogostnosti so opredeljene kot: 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).
English: Co-administration of rifampicin did not affect the pharmacokinetics of palonosetron.
Slovenian: Sočasno dajanje rifampicina ni vplivalo na farmakokinetiko palonosetrona.
English: Netupitant tablets Microcrystalline cellulose (E460) Sucrose lauric acid esters Povidone K-30
Slovenian: Tablete netupitanta mikrokristalna celuloza (E460) estri saharoze in lavrinske kisline povidon K-30 premreženi natrijev karmelozat hidratirani koloidni silicijev dioksid natrijev stearilfumarat magnezijev stearat
English: How to take Akynzeo
Slovenian: Kako jemati zdravilo Akynzeo
English: Three metabolites have been detected in human plasma at netupitant oral doses of 30 mg and higher (the desmethyl derivative, M1; the N-oxide derivative, M2; the OH-methyl derivative, M3).
Slovenian: (derivat desmetila M1, derivat N-oksida M2 in derivat OH-metila M3).
English: In vitro metabolism studies have suggested that CYP3A4 and, to a lesser extent, CYP2D6 and CYP2C9 are involved in the metabolism of netupitant.
Slovenian: Študije presnove in vitro nakazujejo, da pri presnovi netupitanta sodelujejo CYP3A4 ter v manjši meri CYP2D6 in CYP2C9.
English: Rare: (may affect up to 1 in 1,000 people)
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov):
English: Akynzeo is indicated in adults for the: - Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy.
Slovenian: Zdravilo Akynzeo je indicirano pri odraslih za: preprečevanje akutne in zakasnjene navzee in bruhanja, povezanih z zelo emetogeno kemoterapijo na osnovi cisplatina za zdravljenje raka, preprečevanje akutne in zakasnjene navzee in bruhanja, povezanih z zmerno emetogeno kemoterapijo za zdravljenje raka.
English: Akynzeo (Netupitant 300 mg + Palonosetron 0.5 mg) Dexamethasone 12 mg
Slovenian: Zdravilo Akynzeo zdravilo Akynzeo (netupitant 300 mg + palonosetron 0,5 mg) deksametazon 12 mg deksametazon 8 mg enkrat dnevno
English: Each hard capsule contains 300 milligrams of netupitant and 0.5 milligrams of palonosetron (as hydrochloride).
Slovenian: Ena trda kapsula vsebuje 300 miligramov netupitanta in 0,5 miligramov palonosetrona (v obliki klorida).
English: • high level of white blood cells (shown in blood tests).
Slovenian: • visoke ravni belih krvničk (vidno pri krvnih preiskavah).
English: Degeneration of seminiferous epithelium was associated with palonosetron following a one month oral repeat dose toxicity study in rats.
Slovenian: Po enomesečni študiji toksičnosti ponovljenih peroralnih odmerkov pri podganah je bila s palonosetronom povezana degeneracija semenskega epitelija.
English: Akynzeo is taken to help prevent you feeling and being sick when you are having chemotherapy.
Slovenian: Zdravilo Akynzeo jemljete, da bi preprečili občutek slabosti in bruhanje, ko se zdravite s kemoterapijo.
English: 4.8 Undesirable effects
Slovenian: Drugi neželeni učinki
English: • high levels of myoglobin - which indicates muscle injury (shown in blood tests)
Slovenian: • visoke ravni mioglobina, kar kaže na poškodbo mišic (vidno pri krvnih preiskavah);
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Slovenian: Povejte zdravniku, farmacevtu ali medicinski sestri, če opazite katerega koli od naslednjih neželenih učinkov:
English: Back pain Pain in extremities
Slovenian: • bolečina v hrbtu, bolečine v sklepih,
English: The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure.
Slovenian: Med te znake lahko spadajo koprivnica, kožni izpuščaj, srbenje, težave z dihanjem ali požiranjem, otekanje ust, obraza, ustnic, jezika ali grla ter včasih tudi padec krvnega tlaka.
English: Acute phase
Slovenian: Akutna faza ni znač.
English: • high level of ‘lymphocytes'- type of white blood cell which help the body fight disease (shown in blood tests)
Slovenian: • visoke ravni »limfocitov«, ki so vrsta belih krvničk, ki telesu pomagajo pri boju z boleznijo
English: Flushing Hypotension
Slovenian: Žilne bolezni hipertenzija napadi rdečice hipotenzija
English: The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop-in blood pressure.
Slovenian: Znaki lahko vključujejo urtikarijo, kožni izpuščaj, srbenje, oteženo dihanje ali požiranje, otekla usta, obraz, ustnice, jezik ali žrelo in včasih padec krvnega tlaka.
English: Acute phase: 0 to 24 hours after anthracycline and cyclophosphamide regimen Delayed phase: 25 to 120 hours after anthracycline and cyclophosphamide regimen Overall: 0 to 120 hours after anthracycline and cyclophosphamide regimen
Slovenian: Akutna faza: 0 do 24 ur po režimu z antraciklinom in ciklofosfamidom.
English: Cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 0.75 mg.
Slovenian: V povezavi z 0,75 mg palonosetrona so poročali o primerih zaprtja z impakcijo blata, pri katerih je bila potrebna hospitalizacija.
English: How Akynzeo works
Slovenian: Kako deluje zdravilo Akynzeo
English: In vitro metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 are involved in the metabolism of palonosetron.
Slovenian: Študije presnove in vitro nakazujejo, da pri presnovi palonosetrona sodelujejo CYP2D6 ter v manjši meri CYP3A4 in CYP1A2.
English: Hard capsule content:
Slovenian: Ovojnica trde kapsule:
English: Phospholipidosis (foamy macrophages) has been observed with the administration of netupitant after repeated administration in rats and dogs.
Slovenian: Pri ponavljajočem se odmerjanju netupitanta pri podganah in psih so opazili fosfolipidozo (penasti makrofagi).
English: Uncommon: (may affect up to 1 in 100 people)
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov):
English: Netupitant is not mutagenic.
Slovenian: Palonosetron ni mutagen.
English: Netupitant AUC0-∞ and Cmax increased by 1.1 fold and 1.2 fold, respectively, after a high fat meal.
Slovenian: Po obroku z veliko vsebnostjo maščobe sta se AUC0-∞ in Cmax za netupitant povečali za 1,1-krat oziroma 1,2 krat.
English: Each hard capsule contains 300 mg of netupitant and palonosetron hydrochloride equivalent to 0.5 mg of palonosetron.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 300 mg netupitanta in palonosetronijev klorid v količini, ki ustreza 0,5 mg palonosetrona.
English: • high levels of the pigment bilirubin - which indicates liver dysfunction (shown in blood tests)
Slovenian: • visoke ravni pigmenta bilirubina, kar kaže na nepravilno delovanje jeter (vidno pri krvnih preiskavah);
English: N=136
Slovenian: N = 136 % Vrednost p
English: • low level of white blood cells (shown in blood tests)
Slovenian: • nizke ravni belih krvničk (vidno pri krvnih preiskavah);
English: • raised, itchy rash on the skin (hives)
Slovenian: • izbočen, srbeč izpuščaj na koži (koprivnica),
English: Palonosetron Palonosetron 0.5 mg Dexamethasone 20 mg
Slovenian: Palonosetron palonosetron 0,5 mg deksametazon 20 mg deksametazon 8 mg dvakrat dnevno
English: Common: (may affect up to 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov):
English: • low level of potassium (shown in blood tests)
Slovenian: • nizke ravni kalija (vidno pri krvnih preiskavah);
English: Atrioventricular block second degree Conduction disorder Bundle branch block left Tachycardia
Slovenian: Srčne bolezni atrioventrikularni blok prve stopnje aritmija kardiomiopatija atrioventrikularni blok druge stopnje motnja prevajanja levokračni blok tahikardija desnokračni blok popuščanje mitralne zaklopke miokardna ishemija ventrikularne ekstrasistole
English: • high levels of creatinine - which measures kidney function (shown in blood tests)
Slovenian: • visoke ravni kreatinina, ki je merilo delovanja ledvic (vidno pri krvnih preiskavah);
English: Very rare cases of anaphylaxis, anaphylactic/anaphylactoid reactions and shock have been reported from the post-marketing use of intravenous palonosetron.
Slovenian: Pri uporabi intravenskega palonosetrona po začetku trženja so poročali o zelo redkih primerih anafilakse, anafilaktičnih/anafilaktoidnih reakcij in šoka.
English: N=725
Slovenian: N = 725 % Vrednost p*
English: • high levels of troponin - which indicates heart muscle dysfunction (shown in blood tests)
Slovenian: • visoke ravni troponina, kar kaže na nepravilno delovanje srčne mišice (vidno pri krvnih preiskavah);
English: No clinically relevant pharmacokinetic interactions have been observed between oral netupitant and oral palonosetron.
Slovenian: Med peroralnim netupitantom in peroralnim palonosetronom niso opazili klinično pomembnega farmakokinetičnega medsebojnega delovanja.
English: An increased incidence of positional foetal abnormalities of the limbs and paws, fused sternebrae and agenesis of accessory lung lobe were observed following daily administration of netupitant in rabbits at 10 mg/kg/day and higher during the period of organogenesis.
Slovenian: Pri vsakodnevnem odmerjanju netupitanta pri kuncih v odmerkih 10 mg/kg/dan in več v obdobju organogeneze so opazili povečano incidenco fetalnih pozicijskih anomalij pri udih in stopalih, spojenih prsnic in ageneze pomožnega režnja pljučnega krila.
English: such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram
Slovenian: • zdravila za depresijo ali anksioznost, ki jim pravimo SSRI (selektivni zaviralci ponovnega privzema serotonina), kot so fluoksetin, paroksetin, sertralin, fluvoksamin, citalopram ali escitalopram;
English: What Akynzeo contains
Slovenian: Kaj vsebuje zdravilo Akynzeo
English: What Akynzeo is used for
Slovenian: Za kaj uporabljamo zdravilo Akynzeo
English: The usual dose is 1 capsule.
Slovenian: Če ste vzeli večji odmerek zdravila Akynzeo, kot bi smeli Običajen odmerek je 1 kapsula.
English: You may feel dizzy or tired after taking Akynzeo.
Slovenian: Po jemanju zdravila Akynzeo boste morda čutili omotico ali utrujenost.
English: No antiemetic treatment
Slovenian: deksametazon 12 mg brez antiemetičnega zdravljenja
English: Metabolism and nutrition disorders
Slovenian: Infekcijske in parazitske bolezni cistitis
English: • high levels of blood urea - which indicates kidney dysfunction (shown in blood tests)
Slovenian: • visoke ravni sečnine v krvi, kar kaže na moteno delovanje ledvic (vidno pri krvnih preiskavah);
English: This is because it is not known whether the medicine passes into breast milk.
Slovenian: Če jemljete zdravilo Akynzeo, ne smete dojiti, ker ni znano, ali se to zdravilo izloča v materino mleko.
English: What Akynzeo is
Slovenian: Kaj je zdravilo Akynzeo
English: The pharmacokinetic profile of netupitant was unaffected by the concomitant administration of either midazolam or erythromycin.
Slovenian: Sočasno dajanje midazolama ali eritromicina ni vplivalo na farmakokinetični profil netupitanta.
English: Non-cardiac chest pain Product taste abnormal
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost astenija občutek vročine nekardialna bolečina v prsnem košu nenormalen okus zdravila
English: Contains sucrose and sorbitol.See package leaflet for further information.
Slovenian: Vsebuje saharozo in sorbitol.
English: Butylhydroxyanisole (E320)
Slovenian: Vsebina kapsule glicerol monokaprilat monokaprinat (tip I) glicerol poligliceril oleat prečiščena voda butilhidroksianizol (E320)
English: Feeling hot
Slovenian: Okvara jeter
English: Constipation Abdominal distension
Slovenian: Očesne bolezni konjuktivitis zamegljen vid
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu bolečine v okončinah
English: Electrocardiogram ST-T segment abnormal Myoglobin blood increased Neutrophil count increased Troponin increased
Slovenian: Preiskave zvišane jetrne transaminaze zvišan bilirubin v krvi zvišana alkalna fosfataza v krvi zvišana kreatin fosfokinaza v krvi zvišan kreatinin v krvi zvišana kreatin fosfokinaza MB v krvi podaljšanje QT v elektrokardiogramu zvišana sečnina v krvi depresija segmenta ST v elektrokardiogramu nenormalen segment ST-T v elektrokardiogramu zvišan mioglobin v krvi zvišano število nevtrofilcev zvišan troponin
English: No data from animal studies with netupitant are available regarding placental transfer and lactation.
Slovenian: Podatkov iz živalskih študij z netupitantom o prehajanju skozi placento in laktaciji ni. Netupitant ni mutagen.
English: How to store Akynzeo
Slovenian: Shranjevanje zdravila Akynzeo
English: Package Leaflet: Information for the patient
Slovenian: Shranjevanje zdravila Akynzeo Vsebina pakiranja in dodatne informacije
English: • severe allergic reaction signs include hives, skin rash, itching, difficulty breathing or swallowing,
Slovenian: • resna alergijska reakcija; znaki vključujejo koprivnico, kožni izpuščaj, srbenje, težave z dihanjem ali požiranjem, otekanje ust, obraza, ustnic, jezika ali grla ter včasih tudi padec krvnega tlaka.
English: Sorbitol
Slovenian: Damastown
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serij Helsinn Birex Pharmaceuticals Ltd.
English: In addition, the combination used in this study is now contraindicated.
Slovenian: Poleg tega je kombinacija, ki so jo uporabljali v študiji, zdaj kontraindicirana.
English: However, the reasons for a possible earlier death seen in this study are not fully understood.
Slovenian: Vzroki za možno prezgodnjo smrt, ki so jo opazili v tej študiji, pa niso popolnoma jasni.
English: Monitoring should continue for at least 24 months.
Slovenian: Bolnika je treba spremljati vsaj 24 mesecev.
English: Medicine to be used only after two previous treatments or when other treatments cannot be taken
Slovenian: Zdravilo se sme uporabljati samo po dveh predhodnih zdravljenjih ali kadar ni mogoče jemati drugih zdravil
English: More information on Xofigo is available on the EMA website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
Slovenian: Več informacij o zdravilu Xofigo je na voljo na spletni strani agencije EMA: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
English: The review of Xofigo was initiated on 1 December 2017 at the request of the European Commission, Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Xofigo se je začel 1. decembra 2017 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: • If you have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Slovenian: • Če imate kakršna koli vprašanja ali pomisleke glede zdravljenja, se posvetujte z zdravnikom ali farmacevtom.
English: The company that markets Xofigo will have to conduct studies to further characterise these events and clarify the mechanisms behind them.
Slovenian: Podjetje, ki trži zdravilo Xofigo, bo moralo opraviti študije za nadaljnjo opredelitev teh dogodkov in pojasnitev mehanizmov, na katerih temeljijo.
English: It is also not recommended in combination with systemic cancer therapies other than LHRH analogues.
Slovenian: Prav tako ni priporočljivo v kombinaciji s sistemskim zdravljenjem raka, razen z analogi LHRH.
English: • Your doctor will not use the combination of Xofigo and the other two medicines for prostate cancer.
Slovenian: • Vaš zdravnik ne bo uporabil kombinacije zdravila Xofigo in drugih dveh zdravil za zdravljenje raka prostate.
English: The final PRAC recommendations were adopted on 12 July 2018 and then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Slovenian: Odbor PRAC je 12. julija 2018 sprejel končna priporočila in jih poslal Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ta pa je nato sprejel končno mnenje agencije.
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Slovenian: Nadaljnje sistemsko zdravljenje raka se ne sme začeti prej kot 30 dni po zadnjem odmerku zdravila Xofigo.
English: EMA restricts use of prostate cancer medicine Xofigo
Slovenian: Agencija EMA omejuje uporabo zdravila za zdravljenje raka prostate Xofigo
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018 EMA/500948/2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28.
English: • In patients with a high baseline risk of fracture, carefully consider the benefit of treatment against the risks.
Slovenian: • Pri bolnikih z visokim izhodiščnim tveganjem za zlome je treba skrbno pretehtati koristi in tveganja zdravljenja.
English: Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy).
Slovenian: Ne sme se uporabljati z drugimi sistemskimi zdravili za zdravljenje raka, razen z zdravili, ki vzdržujejo znižane ravni moških hormonov (hormonsko zdravljenje).
English: It is authorised for use when medical or surgical castration (stopping the production of male hormones in the body using medicines or surgery) does not work, and when the cancer has spread to the bones and is causing symptoms such as pain but is not known to have spread to other internal organs.
Slovenian: Odobreno je za uporabo, kadar kastracija z zdravili ali kirurška kastracija (prekinitev proizvodnje moških hormonov v telesu z zdravili ali kirurškim posegom) ni učinkovita ter kadar se je rak razširil na kosti in povzroča simptome, kot so bolečine, vendar ni znano, ali se je razširil na druge notranje organe.
English: In the study, patients given the combination with Xofigo died on average 2.6 months earlier than those given the combination with placebo.
Slovenian: V študiji so bolniki, ki so prejemali kombinacijo z zdravilom Xofigo, umrli povprečno 2,6 meseca prej kot bolniki, ki so prejemali kombinacijo s placebom.
English: Xofigo is currently used to treat adult men with cancer of the prostate (a gland of the male reproductive system).
Slovenian: Zdravilo Xofigo se trenutno uporablja za zdravljenje odraslih moških z rakom prostate (žleze moškega reproduktivnega sistema).
English: The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms.
Slovenian: Študija je vključevala bolnike brez simptomov ali z le blagimi simptomi, zdravilo Xofigo pa je odobreno samo za bolnike s simptomi.
English: • In mildly symptomatic patients, the benefit of treatment should be carefully assessed against its risks, considering that high osteoblastic activity is likely to be required for treatment benefit (see below for more information).
Slovenian: • Pri blago simptomatskih bolnikih je treba skrbno oceniti koristi in tveganja zdravljenja, pri čemer je treba upoštevati, da bo zdravljenje verjetno koristno le pri visoki osteoblastni aktivnosti (glejte spodaj za več informacij).
English: An increased fracture risk was found particularly in patients with a medical history of osteoporosis and in patients with fewer than 6 bone metastases.
Slovenian: Povečano tveganje za zlome so odkrili predvsem pri bolnikih z osteoporozo v anamnezi in pri bolnikih z manj kot šestimi kostnimi metastazami.
English: Therefore such preventive measures should be considered before starting or resuming treatment with Xofigo.
Slovenian: Zato je treba pred začetkom ali ponovnim nadaljevanjem zdravljenja z zdravilom Xofigo razmisliti o tovrstnih preventivnih ukrepih.
English: Depending on the results of these tests, Xofigo may be interrupted or stopped, and you may be given an alternative treatment.
Slovenian: Glede na rezultate teh preiskav bo zdravljenje z zdravilom Xofigo morda začasno ali trajno prekinil in prejeli boste drugo zdravilo.
English: In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given the placebo combination.
Slovenian: Poleg tega so se zlomi pojavili pri 29 % bolnikov, ki so prejemali kombinacijo z zdravilom Xofigo, in 11 % bolnikov, ki so prejemali kombinacijo s placebom.
English: It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture.
Slovenian: Domneva se, da se zdravilo Xofigo, ki prehaja v kosti, kopiči na mestih, kjer je kost že poškodovana, na primer zaradi osteoporoze ali mikrozlomov, kar poveča tveganje za zlom.
English: Xofigo must also not be used with the medicines Zytiga (abiraterone acetate) and the corticosteroid prednisone or prednisolone.
Slovenian: Zdravilo Xofigo se tudi ne sme uporabljati z zdravilom Zytiga (abirateron acetatom) ali kortikosteroidom prednizonom ali prednizolonom.
English: • Xofigo is not recommended in patients with a low level of osteoblastic bone metastases and in patients with only asymptomatic bone metastases.
Slovenian: • Zdravilo Xofigo ni priporočljivo pri bolnikih z nizko ravnjo osteoblastnih kostnih metastaz in pri bolnikih s samo asimptomatskimi kostnimi metastazami.
English: • Before starting and during treatment with Xofigo, your doctor may also give you a medicine to protect your bones from fractures.
Slovenian: • Pred začetkom zdravljenja z zdravilom Xofigo in med njim vam bo zdravnik morda dal tudi zdravilo, ki bo ščitilo vaše kosti pred zlomi.
English: • Before, during, and after treatment with Xofigo your doctor will carry out tests to check the health status of your bones.
Slovenian: • Pred in med zdravljenjem z zdravilom Xofigo ter po njem bo zdravnik opravil preiskave in preveril zdravstveno stanje vaših kosti.
English: • Before starting and during treatment with Xofigo, an assessment of patients' bone status (e.g. by scintigraphy, bone mineral density measurement) and risk of fractures (e.g. osteoporosis, fewer than 6 bone metastases, medication increasing fracture risk, low body mass index) should be performed.
Slovenian: • Pred začetkom zdravljenja z zdravilom Xofigo in med njim je treba opraviti oceno stanja bolnikovih kosti (npr. s scintigrafijo, meritvijo mineralne kostne gostote kosti) in tveganja za zlome (npr. osteoporoza, manj kot šest kostnih metastaz, zdravila, ki povečujejo tveganje za zlom, nizek indeks telesne mase).
English: • The use of Xofigo is associated with an increased risk of fractures.
Slovenian: • Uporaba zdravila Xofigo je povezana s povečanim tveganjem za zlome.