FrancophonIA/ELRC3.0 huggingface dataset:
English: After one month of treatment, more patients on Kineret (6 out of 12 patients) achieved remission compared with treatment with DMARD (3 out of 10 patients).
Slovenian: Po enem mesecu zdravljenja je remisijo doseglo več bolnikov, ki so prejemali zdravilo Kineret (6 od 12), kot bolnikov, ki so prejemali DMARD (3 od 10).
English: For CAPS, Kineret has been studied in one main study involving 43 patients with neonatal-onset multisystem inflammatory disease (NOMID/CINCA syndrome, the most severe form of CAPS).
Slovenian: Zdravilo Kineret so pri bolnikih, ki imajo s kriopirinom povezane sindrome, proučevali v eni glavni študiji, ki je zajela 43 bolnikov z multisistemsko vnetno boleznijo z začetkom pri novorojenčku (sindrom NOMID/CINCA, najhujša oblika s kriopirinom povezanih sindromov).
English: All three studies compared the effectiveness of Kineret with that of placebo (a dummy treatment).
Slovenian: V vseh treh študijah so učinkovitost zdravila Kineret primerjali s placebom (zdravilom brez učinkovine).
English: Kineret must not be used in people who are hypersensitive (allergic) to anakinra, to any of the other ingredients, or to proteins produced by Escherichia coli (a type of bacterium).
Slovenian: Zdravila Kineret ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) učinkovino anakinra, katero koli drugo sestavino zdravila ali beljakovine, ki jih tvori Escherichia coli (vrsta bakterije).
English: It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone;
Slovenian: Uporablja se v kombinaciji z metotreksatom (zdravilom za ublažitev vnetja) pri bolnikih z nezadostnim odzivom na metotreksat kot samostojno zdravilo;
English: Kineret is available as a solution for injection under the skin.
Slovenian: Zdravilo Kineret je na voljo v obliki raztopine za injiciranje v podkožje.
English: Kineret can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of rheumatoid arthritis, CAPS or Still's disease as appropriate.
Slovenian: Predpisovanje in izdaja zdravila Kineret je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem revmatoidnega artritisa, s kriopirinom povezanih sindromov oziroma Stillove bolezni.
English: CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.
Slovenian: S kriopirinom povezani sindromi so skupina bolezni, pri kateri imajo bolniki okvaro gena, ki proizvaja beljakovino kriopirin.
English: In the study using a fixed dose of Kineret, 38% of the patients adding Kineret had at least a 20% reduction in symptoms after six months, compared with 22% of those adding placebo.
Slovenian: V študiji, v kateri so uporabljali stalni odmerek zdravila Kineret, je bilo pri 38 % bolnikov, ki so kot dodatek prejemali zdravilo Kineret, po šestih mesecih opaženo najmanj 20-odstotno zmanjšanje simptomov, medtem ko je bil pri bolnikih, ki so kot dodatek prejemali placebo, ta delež 22 %.
English: The European Medicines Agency decided that Kineret's benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Kineret pri zdravljenju znakov in simptomov revmatoidnega artritisa v kombinaciji z metotreksatom pri bolnikih z nezadostnim odzivom na metotreksat kot samostojno zdravilo večje od z njim povezanih tveganj.
English: This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain and tiredness.
Slovenian: Zaradi tega pride do vnetja na številnih delih telesa s simptomi, kot so povišana telesna temperatura, izpuščaji, bolečine v sklepih in utrujenost.
English: adult patients who also received corticosteroids for their disease.
Slovenian: Tretjo študijo so izvedli pri 22 odraslih bolnikih, ki so zaradi svoje bolezni prejemali tudi kortikosteroide.
English: Given the beneficial effect and the fact that there were no new safety concerns, the Agency also considered that the benefits outweighed the risks in patients with CAPS and Still's disease.
Slovenian: Zaradi ugodnega učinka in dejstva, da ni bilo ugotovljenih nobenih zadržkov glede varnosti, je menila, da tudi pri bolnikih, ki imajo s kriopirinom povezane sindrome ali Stillovo bolezen, koristi zdravila Kineret odtehtajo tveganja.
English: How is Kineret used?
Slovenian: Kako se zdravilo Kineret uporablja?
English: This messenger is produced in high levels in patients with rheumatoid arthritis, causing inflammation of the joints and joint damage, and is also involved in the inflammation associated with CAPS and Still's disease.
Slovenian: Ta prenašalec pri bolnikih z revmatoidnim artritisom nastaja v velikih količinah, kar povzroča vnetje in poškodbe sklepov, vpleten pa je tudi v proces vnetja, značilnega za s kriopirinom povezane sindrome in Stillovo bolezen.
English: For the full list of side effects of Kineret, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kineret, glejte navodilo za uporabo.
English: In the first study, 11 of 15 children with Still's disease (73 %) had at least a 30% reduction in symptoms after three months treatment with Kineret.
Slovenian: V prvi študiji so se simptomi po treh mesecih zdravljenja z zdravilom Kineret pri 11 od 15 otrok s Stillovo boleznijo (73 %) zmanjšali vsaj za 30 %.
English: • Still's disease, a disease causing inflammation of joints as well as rash and fever.
Slovenian: • Stillove bolezni, tj. bolezni, ki povzroča vnetje sklepov ter izpuščaj in povišano telesno temperaturo.
English: For CAPS and Still's disease, the dose depends on body weight and for CAPS, on the severity of the condition.
Slovenian: Pri bolnikih, ki imajo s kriopirinom povezane sindrome ali Stillovo bolezen, je odmerek odvisen od njihove telesne mase in, pri s kriopirinom povezanih sindromih, od resnosti bolezni.
English: How does Kineret work?
Slovenian: Kako zdravilo Kineret deluje?
English: For CAPS and Still's disease, Kineret is used in patients from 8 months of age and weighing at least 10 kg. Kineret contains the active substance anakinra.
Slovenian: Pri s kriopirinom povezanih sindromih in Stillovi bolezni se zdravilo Kineret uporablja pri bolnikih od 8. meseca starosti naprej, ki tehtajo vsaj 10 kg.
English: For more information about using Kineret, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic mora zdravnik razmisliti o dajanju zdravila Kineret vsak drugi dan. Za več informacij glede uporabe zdravila Kineret glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The overall safety was maintained during all cycles.
Slovenian: Celotna varnost je obdržana v teku vseh ciklusov
English: Date of first authorisation: 08 April 2016
Slovenian: Datum prve odobritve: 8. april 2016
English: 10 μg/kg
Slovenian: 10 µg/kg
English: Ten percent of patients have a mean terminal elimination halflife greater than 100 hours.
Slovenian: Deset odstotkov bolnikov ima srednji končni eliminacijski razpolovni čas višji od 100 ur.
English: • At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: • high levels of sugar in the blood or sugar in the urine
Slovenian: • zvišana koncentracija sladkorja v krvi ali sladkor v urinu
English: Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake 'EXP'.
English: • high levels of certain liver enzymes
Slovenian: • visoke koncentracije nekaterih jetrnih encimov
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden boste prejeli to zdravilo.
English: Manufacturer Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Slovenian: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, Velika Britanija
English: This leaflet was last revised in month YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne mesec LLLL
English: Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3 -antagonist administration.
Slovenian: Hipokaliemijo in hipomagneziemijo je treba korigirati pred uvedbo antagonistov 5-HT3.
English: The antiemetic activity was observed during 0-24 hours, 24-120 hours and 0-120 hours.
Slovenian: Antiemetično učinkovitost so opazovali od 0-24 ur, 24-120 ur in 0- 120 ur.
English: Via Fosse Ardeatine, 2, 20060, Liscate (MI) Italy
Slovenian: Via Fosse Ardeatine, 2, 20060, Liscate (MI) Italija
English: • high or low blood pressure
Slovenian: • zvišan ali znižan krvni tlak
English: • change in the colour of the vein and/or veins becoming larger
Slovenian: • sprememba barve vene in/ali razširitev ven
English: • abdominal (stomach) pain
Slovenian: • bolečine v trebuhu (želodcu)
English: It is not known whether Palonosetron Hospira will cause any harmful effects when used during pregnancy.
Slovenian: Ni znano, ali bo zdravilo Palonosetron Hospira povzročilo škodljive učinke med uporabo v nosečnosti.
English: • weakness, tiredness, fever or flu like symptoms
Slovenian: • šibkost, utrujenost, vročina ali gripi podobni simptomi
English: Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgium
Slovenian: Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgija
English: Palonosetron Hospira should be injected over 30 seconds.
Slovenian: Zdravilo Palonosetron Hospira je potrebno injicirati v 30 sekundah.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
Slovenian: Druga zdravila in zdravilo Palonosetron Hospira Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z:
English: The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives), burning or pain at the site of injection.
Slovenian: Znaki lahko vključujejo otekle ustnice, obraz, jezik ali žrelo, oteženo dihanje ali kolaps, lahko bi opazili tudi srbeč, izbokel izpuščaj (koprivnico), občutek pečenja ali bolečino na mestu injekcije.
English: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italy
Slovenian: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060 Liscate (MI), Italija
English: Significance level at α=0.05.
Slovenian: Hi kvadrat test. Signifikanca je α = 0,05.
English: In the palonosetron 10 μg/kg, 20 μg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Slovenian: V skupinah s palonosetronom 10 µg/kg, 20 µg/kg in ondansetroom je bil delež bolnikov s CR0-24h 54,2 %, 59,4 % in 58,6 %.
English: When the dose was increased from 10 μg/kg to 20 μg/kg a dose-proportional increase in mean AUC was observed.
Slovenian: Ko so odmerek zvečali z 10 µg/kg na 20 µg/kg, so opazili odmerku sorazmerno zvečanje povprečne AUC.
English: Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Palonosetron Hospira overdose.
Slovenian: Raziskave z dializo niso bile opravljene, vendar zaradi velikega volumna porazdelitve, zdravljenje z dializo najverjetneje ni učinkovito pri prevelikem odmerku zdravila Palonosetron Hospira.
English: Prevention of Chemotherapy Induced Nausea and Vomiting (CINV):
Slovenian: Preprečevanje s kemoterapijo povzročene navzee inbruhanja (Chemotherapy Induced Nausea and Vomiting - CINV):
English: Serotonergic Drugs (e.g. SSRIs and SNRIs)
Slovenian: Serotoninergična zdravila (npr.SSRI in SNRI)
English: A doctor or nurse will normally inject Palonosetron Hospira about 30 minutes before the start of chemotherapy.
Slovenian: Zdravnik ali medicinska sestra bosta običajno zdravilo Palonosetron Hospira injicirala 30 minut pred začetkom kemoterapije.
English: Adults Cancer Patients
Slovenian: Odrasli bolniki z rakom
English: Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron.
Slovenian: Približno 40 % se ga izloči preko ledvic, 50 % pa se ga metabolizira v dva primarna metabolita, ki imata manj kot 1 % aktivnosti antagonista receptorja 5HT3
English: • abnormal heart rate or lack of blood flow to the heart
Slovenian: • nenormalna frekvenca srca ali premajhen dotok krvi v srce
English: If you are pregnant or think you might be, your doctor will not administer Palonosetron Hospira to you unless it is clearly necessary.
Slovenian: Če ste noseči ali mislite, da ste, vam bo zdravnik dal zdravilo Palonosetron Hospira le v primeru, da je to nujno potrebno.
English: In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9 %) and constipation (5 %).
Slovenian: V kliničnih študijah pri odraslih pri odmerku 250 mikrogramov (skupaj 633 bolnikov) sta bila najpogostejša neželena učinka, ki ju je mogoče pripisati palonosetronu, glavobol (9 %) in zaprtje (5 %).
English: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, The Netherlands
Slovenian: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, Nizozemska
English: Given the pre-specified noninferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Slovenian: Ob vnaprej določeni meji ne-manjvrednosti, ki je bila -10 %, je bil MantelHaenszlov statistični ne-manjvrednostni interval zaupanja s prilagojeno stratifikacijo za razliko v primarnem kriteriju, popolnem odgovoru (CR), [-10,5, 1,7 %], kar pomeni, da ne-manjvrednost ni bila dokazana.
English: Palonosetron Hospira will be given as a slow infusion into a vein.
Slovenian: Zdravilo Palonosetron Hospira bodo dajali kot počasno infuzijo v veno.
English: Palonosetron Hospira is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age.
Slovenian: Zdravilo Palonosetron Hospira se uporablja za preprečevanje slabosti in bruhanja pri kemoterapiji raka pri odraslih bolnikih, mladostnikih in otrocih, starejših od enega meseca.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since Palonosetron Hospira is intended for single application in humans, these findings are not considered relevant for clinical use.
Slovenian: Odgovorni mehanizmi niso znani, vendar ti podatki zaradi visokih uporabljenih odmerkov in nameravane uporabe zdravila Palonosetron Hospira kot enkratne aplikacije pri ljudeh, klinično niso relevantni.
English: • SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Slovenian: • SNRI (zaviralci privzema serotonina in noradrenalina), ki se uporabljajo za zdravljenje depresivnosti in/ali anksioznosti, vključno z venlafaksinom, duloksetinom.
English: CYP2D6 inducers and inhibitors.
Slovenian: Induktorji in inhibitorji CYP2D6
English: Palonosetron Hospira is indicated in adults for:
Slovenian: Zdravilo Palonosetron Hospira je indicirano pri odraslih za:
English: Table 4: Pharmacokinetic Parameters in Paediatric Cancer Patients following intravenous infusion of palonosetron at 20 μg/kg over 15 min and in Adult Cancer Patients receiving 3 and 10 μg/kg palonosetron doses via intravenous bolus.
Slovenian: Preglednica 4: Farmakokinetični parametri pri pediatričnih bolnikih z rakom po intravenski infuziji palonosetrona s hitrostjo 20 µg/kg v času 15 min in pri odraslih bolnikih z rakom, ki so prejeli odmerka 3 in 10 µg/kg palonosetrona v obliki intravenskega bolusa.
English: Type I glass vial with a chlorobutyl rubber stopper and aluminium seal.
Slovenian: Viala iz stekla tipa I z zamaškom iz klorobutilne gume in aluminijasto zaporko.
English: • high levels of the pigment bilirubin in the blood
Slovenian: • visoka koncentracija barvila bilirubina v krvi
English: Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for:
Slovenian: Zdravilo Palonosetron Hospira je indicirano pri pediatričnih bolnikih od starosti 1 meseca naprej za:
English: For palonosetron no clinical data on exposed pregnancies are available.
Slovenian: Za palonosetron ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
English: • low levels of calcium in the blood
Slovenian: • znižana koncentracija kalcija v krvi
English: There are limited data on the use of palonosetron in the prevention of nausea and vomiting in children under 2 years of age.
Slovenian: Podatkov o uporabi palonosetrona za preprečevanje navzee in bruhanja pri otrocih, mlajših od 2 let, je malo.
English: • decrease or loss of appetite
Slovenian: • zmanjšanje ali izguba teka
English: Since the 97.5% confidence interval (stratum adjusted Mantel-Haenszel test) of the difference in CR0-24h between palonosetron 20 μg/kg and ondansetron was [-11.7%, 12.4%], the 20 μg/kg palonosetron dose demonstrated non-inferiority to ondansetron.
Slovenian: Ker je bil 97,5-odstotni interval zaupanja (stratifikacija prilagojena Mantel-Haenszelovemu testu) razlike v CR0-24h med palonosetronom 20 µg/kg in ondansetronom [-11,7 %, 12,4 %], je bil palonosetron v odmerku 20 µg/kg ne-manjvreden ondansetronu.
English: • if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Palonosetron Hospira ne smete prejeti: - če ste alergični na palonosetron ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • pain at the site of infusion
Slovenian: • bolečina na mestu infuzije.
English: It is not known if Palonosetron Hospira is found in breast milk.
Slovenian: Ni znano, ali zdravilo Palonosetron Hospira prehaja v materino mleko.
English: What Palonosetron Hospira looks like and contents of the pack Palonosetron Hospira solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with a chlorobutyl rubber stopper and aluminium cap, which contains 5 ml of the solution.
Slovenian: Izgled zdravila Palonosetron Hospira in vsebina pakiranja Raztopina za injiciranje zdravila Palonosetron Hospira je bistra, brezbarvna raztopina, na voljo je v pakiranju, v katerem je ena viala iz stekla tipa I z zamaškom iz klorobutilne gume in aluminijasto zaporko, ki vsebuje 5 ml raztopine.
English: • elevated moods or feelings of anxiousness
Slovenian: • obdobja vznesenega razpoloženja ali občutki zaskrbljenosti
English: It is not recommended to receive Palonosetron Hospira in the days following chemotherapy unless you are receiving another chemotherapy cycle.
Slovenian: Zdravila Palonosetron Hospira ni priporočljivo jemati v dneh, ki sledijo kemoterapiji, razen če prejemate naslednji ciklus kemoterapije.
English: Median half-life was 29.5 hours in overall age groups and ranged from about 20 to 30 hours across age groups after administration of 20 μg/kg.
Slovenian: Mediana razpolovna doba v vseh starostnih skupinah skupaj je bila 29,5 ure, v posameznih starostnih skupinah pa je bila po dajanju 20 µg/kg v mejah od okrog 20 do 30 ur.
English: Paediatric Cancer Patients
Slovenian: Pediatrični bolniki z rakom
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 μg/kg or 3 μg/kg (88% vs 84%).
Slovenian: Razmerje bolnikov brez bruhanja v 0-72 urah po operaciji je bilo podobno pri uporabi palonosetrona 1 µg/kg (88 %) in 3 µg/kg (84 %).
English: What you need to know before you are given Palonosetron Hospira
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Palonosetron Hospira
English: Hospira Enterprises B.V. Randstad 22-11 Almere NL-1316 BN The Netherlands
Slovenian: Randstad 22-11 Almere NL-1316 BN Nizozemska
English: Volume of distribution c, d,
Slovenian: Očistek c, l/h/kg Volumen porazdelitve c, d
English: • abnormally high or low levels of potassium in the blood
Slovenian: • nenormalno visoka ali nizka koncentracija kalija v krvi
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'
English: A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 μg/kg (maximum 0.75 mg), palonosetron 20 μg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
Slovenian: Vsega skupaj 493 pediatričnih bolnikov, starih od 64 dni do 16,9 let, ki so prejemali zmerno (69,2 %) ali visoko emetogeno kemoterapijo (30,8 %), so zdravili s palonosteronom 10 µg/kg (največji odmerek 0,75 mg), palonosetronom 20 µg/kg (največji odmerek 1,5 mg) ali ondansetronom (3 x 0,15 mg/kg , največji celotni odmerek 32 mg) 30 minut pred začetkom emetogene kemoterapije med ciklom 1.
English: Palonosetron Hospira should be used only before chemotherapy administration.
Slovenian: Zdravilo Palonosetron Hospira se sme uporabiti samo pred dajanjem kemoterapije.
English: • electrocardiogram abnormalities (QT prolongation)
Slovenian: • nenormalnosti elektrokardiograma (podaljšanje intervala QT)
English: The efficacy of palonosetron for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an intravenous ondansetron regimen.
Slovenian: Učinkovitost palonosetrona za preprečevanje navzee in bruhanja, ki ju povzroča kemoterapija, pri pediatričnih bolnikih z rakom, so pokazali v drugem ključnem preskušanju ne-manjvrednosti, v katerem so primerjali enkratno intravensko infuzijo palonosetrona z i.v.
English: Palonosetron Hospira belongs to a group of medicines known as serotonin (5HT3) antagonists.
Slovenian: Zdravilo Palonosetron Hospira spada v skupino zdravil, znanih pod imenom antagonisti serotoninskih 5HT3 receptorjev.
English: In the unlikely event of overdose with Palonosetron Hospira, this should be managed with supportive care.
Slovenian: V malo verjetnem primeru prevelikega odmerka zdravila Palonosetron Hospira je potrebno le podporno zdravljenje.
English: L/kg
Slovenian: , l/kg a
English: • sleepiness or trouble sleeping
Slovenian: • zaspanost ali nespečnost
English: <2 y 2 to <6 y 6 to <12 y 12 to <17 y μg/kg
Slovenian: 2 do <6 let6 do <12 let
English: Paediatric population No case of overdose has been reported in paediatric clinical studies.
Slovenian: V pediatričnih kliničnih študijah niso poročali o nobenem primeru prevelikega odmerjanja.