natgillin/translations-raw huggingface dataset:
It is not recommended to use systemic corticosteroid medicinal products due to possible interference with immune activation which is necessary for the therapeutic action of dinutuximab.
Uporaba zdravil s sistemskimi kortikosteroidi ni priporočljiva zaradi možne interference z imunsko aktivacijo, ki je potrebna za terapevtski učinek dinutuksimaba.
Patients were aged 11 months to 15 years and had previously achieved at least a partial response to induction chemotherapy, followed by ASCT and radiotherapy.
Bolniki so bili stari od 11 mesecev do 15 let in so prej dosegli vsaj delni odgovor na indukcijsko kemoterapijo, kateri sta sledili ASCT in radioterapija.
During courses (months) 1, 3 and 5
Med cikli (meseci) 1, 3 in 5
If patients meet criteria for discontinuation of these medications, treatment may continue with isotretinoin as clinically indicated.
Če bolnik izpolnjuje pogoje za prekinitev jemanja teh zdravil, se zdravljenje lahko nadaljuje z izotretinoinom, kot je klinično indicirano.
Each carton contains one vial.
Vsaka ovojnina vsebuje eno vialo.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER United Therapeutics Europe, Ltd.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM United Therapeutics Europe, Ltd.
If morphine is not tolerated, then fentanyl or hydromorphone may be utilised.
Če bolnik ne prenaša morfina, se lahko uporabi fentanil ali hidromorfon.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku poleg oznake EXP.
Other medicines and Unituxin
Druga zdravila in Unituxin
Due to overlapping signs and symptoms, it was not possible to distinguish between infusion reactions and hypersensitivity/allergic reactions in some cases.
Zaradi prekrivajočih se znakov in simptomov v določenih primerih ni bilo mogoče razlikovati med infuzijskimi reakcijami in preobčutljivostjo oz. alergijskimi reakcijami.
Systemic infections
Sistemske okužbe
Patients should have no evidence of systemic infection and any identified infection should be under control before beginning therapy.
Bolniki ne smejo kazati simptomov sistemskih okužb in katera koli ugotovljena okužba pred začetkom terapije pa mora biti nadzorovana.
If necessary, its use must be limited to the first 100 days after ASCT, as immunoglobulin may interfere with dinutuximab-dependent cellular cytotoxicity.
Če so potrebni, je treba uporabo omejiti na prvih 100 dni po ASCT, ker imunoglobulin lahko vpliva na celično citotoksičnost dinutuksimaba.
Severe pain (Grade 3 or 4) occurs most frequently during the first 4-day course of dinutuximab, often subsiding over time with subsequent courses.
Hude bolečine (stopnja 3 ali 4) se najpogosteje pojavijo v prvih štirih dneh cikla z dinutuksimabom in se običajno ublažijo med naslednjimi cikli.
• It is recommended to use contraception for 6 months after discontinuation of this medicine.
• Priporočeno je, da 6 mesecev po prenehanju zdravljenja s tem zdravilom uporabljate kontracepcijo.
The European Medicines Agency has deferred the obligation to submit the results of studies with Unituxin in one or more subsets of the paediatric population in neuroblastoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Unituxin za eno ali več podskupin pediatrične populacije z nevroblastomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v šestih mesecih po pridobitvi dovoljenja za promet.
In animals, fertility studies have not been conducted; however in male and female rats, no adverse effects on reproductive organs were observed (see section 5.3).
Študij o plodnosti pri živalih niso izvedli, vendar pa pri miših ženskega in moškega spola niso bili opaženi neželeni učinki na reproduktivne organe (glejte poglavje 5.3).
Unituxin will be given to you in five of the six courses.
Zdravilo Unituxin boste jemali v petih od šestih ciklov.
Therefore caution should be taken when both medicinal products are combined (see section 4.4).
Zato je potrebna previdnost ob uporabi kombinacije obeh zdravil (glejte poglavje 4.4).
Unituxin has been shown to delay the progression or relapse of the disease and to increase survival.
Dokazano je, da zdravilo Unituxin zavira napredovanje oziroma ponoven pojav bolezni in povečuje preživetje.
Depending on the severity of the allergic reaction, the rate of infusion should be reduced or treatment discontinued.
Glede na resnost alergijske reakcije je potrebno zmanjšati hitrost infuzije oziroma prekiniti zdravljenje.
• Allergic reactions, which may be severe (anaphylactic reactions), or other reactions to the infusion - Tell your doctor or nurse straight away if you have any kind of reaction during or after the infusion.
• Alergijske reakcije, ki so lahko hude (anafilaktične reakcije) ali druge reakcije na infuzijo nemudoma obvestite svojega zdravnika ali medicinsko sestro, če se pojavi katera koli reakcija med infuzijo ali po njej.
It is recommended that vasopressor therapy is also administered if necessary to restore an adequate perfusion pressure.
Priporoča se, da se daje tudi vazopresorska podpora, če je potrebno ponovno vzpostaviti primerni tlak.
See section 2 for further information about sodium.
Glejte poglavje 2 za dodatne informacije o natriju.
Table 3: Clinical criteria that must be evaluated prior to the start of each treatment course of Unituxin
Preglednica 3: Klinični kriteriji, ki jih je treba oceniti pred začetkom posameznega cikla zdravljenja z zdravilom Unituxin
The complete dosing regimen is outlined in Table 1 and Table 2.
Celotni režim odmerjanja je naveden v Preglednici 1 in Preglednici 2.
Patients should have an ophthalmic examination before initiating therapy and be monitored for visual changes.
Bolniki morajo na oftalmološki pregled preden začnejo s terapijo in jih je treba spremljati glede sprememb vida.
During courses (months) 2 and 4
Med cikli (meseci) 2 in 4
The primary efficacy outcome measure was investigator-assessed event-free survival (EFS) defined as time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death.
Primarni cilj študije je bilo s strani raziskovalca ocenjeno preživetje brez bolezenskih dogodkov (EFS), opredeljeno kot čas randomizacije do prvega pojava relapsa, progresivne bolezni, sekundarnega malignoma ali smrti.
• Delay course initiation until systemic infection or sepsis has resolved.
• Odložite začetek cikla zdravljenja, dokler sistemska infekcija ali sepsa ni odpravljena.
Unituxin is restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies.
Zdravilo Unituxin je namenjeno samo uporabi v bolnici in pod nadzorom zdravnika, ki ima izkušnje z onkološkimi terapijami.
The infusion duration may be extended up to 20 hours to help minimise reactions during infusion that do not respond adequately to other supportive measures.
Trajanje infuzije se lahko podaljša do 20 ur za zmanjšanje reakcij med infundiranjem, ki se ne odzovejo primerno na ostale podporne ukrepe.
Keep the vial in the outer carton in order to protect from light.
Vialo za zdravilo shranjujte v zunanji ovojnini, da jo zaščitite pred svetlobo.
• 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.
• 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.
- The other ingredients are histidine, polysorbate 20 (E 432), sodium chloride and water for injection.
- Druge sestavine zdravila so histidin, polisorbat 20 (E 432), natrijev klorid in voda za injekcije.
One carton contains one vial.
Ena ovojnina vsebuje eno vialo.
Dinutuximab was administered to cynomolgous monkeys resulting in effects on the cardiovascular system, which consisted of moderate increases in blood pressure (one of three animals) and heart rate (two of three animals).
Dinutuksimab je bil apliciran opicam Cynomolgus, kar je povzročilo učinke na kardiovaskularnem sistemu v obliki zmernega povišanja krvnega tlaka (v eni od treh živali) in srčnega utripa (v deh od treh živali).
The mean (± standard deviation) maximum plasma concentration observed after the 4th infusion was 11.5 (± 2.3) mcg/mL.
Povprečna (± standardni odklon) koncentracija dinutuksimab v plazmi po četrti infuziji je bila 11,5 (± 2,3) mcg/ml.
The incidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay and for these reasons, comparison of the incidence of antibodies to dinutuximab with the incidence of antibodies to other products may be misleading.
Incidenca formiranja protiteles je v veliki meri odvisna od občutljivosti in specifičnosti poskusa, zato je lahko primerjava med incidenco protiteles na dinutuksimab in incidenco protiteles na druga zdravila zavajajoča.
Unituxin has major influence on the ability to drive and use machines.
Zdravilo Unituxin ima močan vpliv na sposobnost vožnje in upravljanja s stroji.
The dose may be subsequently increased (up to a maximum of 60 mg/kg/day or 3600 mg/day) as needed for pain management.
Odmerek se nato po potrebi lahko poveča (do največ 60 mg/kg/dan ali 3600 mg/dan) za lajšanje bolečin.
It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available.
Zdravilo mora aplicirati zdravnik, ki je pripravljen za ukrepanje v primeru hudih alergijski reakcij, vključno z anafilaksijo, v okolju, kjer je na voljo vse potrebno za reanimacijo.
The geometric mean clearance was estimated at 0.025 L/hr and increased with body size.
Izločanje Povprečno geometrično izločanje je bilo ocenjeno na 0,25 l/uro in se je povečalo s telesno velikostjo.
It should be administered by intravenous infusion over 10 hours.
Treba ga je dajati kot intravensko infuzijo po 10 ur.
In a population pharmacokinetic analysis, the geometric mean volume of distribution at steady state was estimated at 5.2 L.
Pri farmakokinetični populacijski analizi je bil geometrični povprečni volumen porazdelitve v stanju dinamičnega ravnovesja 5.2 l.
Additionally, in vivo studies demonstrate that dinutuximab either alone or in combination with IL-2 can partially inhibit tumour growth in mice.
Poleg tega so študije in vivo dokazale, da dinutuksimab sam ali v kombinaciji z IL-2 lahko delno inhibira rast tumorja v miših.
Chemical and physical in-use stability has been demonstrated for 24 hours at ambient conditions (less than 25°C).
Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 24 ur na sobni temperaturi (manj kot 25 °C).
The most frequently occurring (more than 30% of patients) adverse reactions reported during the neuroblastoma studies were hypotension (67 %), pain (66 %), hypersensitivity (56 %), pyrexia (53 %), urticaria (49 %), capillary leak syndrome (45 %), anaemia (45 %), hypokalaemia (41 %), platelet count decreased (40 %), hyponatraemia (37 %), alanine aminotransferase increased (35 %), decreased lymphocyte count (34%) and decreased neutrophil count (31%).
Najbolj pogosti neželeni učinki (več kot 30 % bolnikov) o katerih so poročali v študijah nevroblastoma so hipotenzija (67 %), bolečine (66 %), preobčutljivost (56 %), pireksija (53 %), urtikarija (49 %), sindrom kapilarnih razpok (45 %), anemija (45 %), hipokalemija (41 %), zmanjšanje števila trombocitov (40 %), hiponatremija (37 %), povišanje alanin-aminotransferaze (35 %), zmanjšanje števila limfocitov (34 %) in zmanjšanje števila nevtrofilov (31 %).
Pregnancy There are no data from the use of dinutuximab in pregnant women.
Podatkov o uporabi dinutuksimaba pri nosečnicah ni.
Dinutuximab reacts specifically with the ganglioside GD2, which is highly expressed on the surface of neuroblastoma cells and minimally expressed on the surface of normal human neurons, peripheral pain fibres, and skin melanocytes.
Dinutuksimab reagira specifično z gangliozidom GD2, ki je močno izražen na površini celic nevroblastoma in minimalno izražen na površini normalnih humanih nevronov, perifernih bolečinskih vlaken in kožnih melanocitov.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
V primeru prevelikega odmerjanja je treba pri bolnikih natančno spremljati znake ali simptome neželenih učinkov in izvesti primerno simptomatično terapijo.
Peripheral sensory neuropathy was reported in 3% of patients and peripheral motor neuropathy in 2% of patients; less than 1% of patients experienced serious peripheral neuropathy.
Do periferne senzorne nevropatije je prišlo pri 3 % bolnikov, do periferne motorične nevropatije pa pri 2 % bolnikov, medtem ko je do resne periferne nevropatije prišlo pri manj kot 1 % bolnikov.
It is recommended that antihistamine medicinal product be repeated every 4-6 hours as required during infusion of Unituxin.
Priporoča se, da se dajanje antihistaminika ponovi vsakih 4-6 ur, kot je zahtevano med infuzijo zdravila Unituxin.
Symptomatic and/or systolic BP less than 70 mmHg or a decrease that is more than 15% below baseline Onset of symptoms
Simptomatski in/ali sistolični krvni tlak pod 70 mmHg ali upadanje, ki je več kot 15 % pod standardno mejo Nastop simptomov
In male and female rats, administration of dinutuximab resulted in no adverse effects on reproductive organs at exposures that were at least 60-fold higher than those observed clinically.
Aplikacija dinutuksimaba podganam moškega in ženskega spola ni povzročilo neželenih učinkov na reproduktivne organe pri izpostavljenosti, ki je bila najmanj 60-krat višja od klinične izpostavljenosti.
What Unituxin is and what it is used for 2.
Kaj je zdravilo Unituxin in za kaj ga uporabljamo 2.
These medicines will be given to you over six courses.
Ta zdravila boste jemali v šestih ciklih zdravljenja.
Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC16
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC16
Chemical and physical in-use stability has been demonstrated at ambient conditions (less than 25 °C).
Kemična in fizikalna stabilnost med uporabo sta bili dokazani pri sobni temperaturi (manj kot 25 °C).
Depending on the severity of the allergic reaction, the rate of infusion should be reduced or treatment discontinued (see sections 4.2 and 4.8).
Glede na resnost alergijske reakcije je potrebno zmanjšati hitrost infuzije oziroma prekiniti zdravljenje (glejte poglavji 4.2 in 4.8).
See section 4 for a full list of known side effects.
Glejte poglavje 4 za popoln seznam znanih neželenih učinkov.
From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
Iz mikrobiološkega vidika je razredčeno raztopino treba uporabiti takoj, razen če metoda odpiranja/ obnavljanja/redčenja ne preprečuje tveganja mikrobiološke kontaminacije.
• If symptoms resolve that day, resume the next day with premedication in the intensive care setting (see section 4.4).
• Če simptomi izzvenijo tisti dan, naslednji dan ponovno začnite premedikacijo v intenzivni negi (glejte poglavje 4.4).
• Low blood pressure - this may make you feel dizzy or faint.
• Nizek krvni tlak - ta lahko povzroča omotico ali omedlevico.
Clear, colourless liquid.
Prozorna, brezbarvna tekočina.
The infusion duration may be extended up to 20 hours to help minimise reactions during infusion (see sections 4.4 and 4.8) that do not respond adequately to other supportive measures.
Trajanje infuzije se lahko podaljša do 20 ur za zmanjšanje reakcij med infundiranjem (glejte poglavji 4.4 in 4.8), ki se ne odzovejo primerno na ostale podporne ukrepe.
These changes were noted to be very slight to slight in severity and recovered or tended to recover following the cessation of dosing.
Resnost teh sprememb je bila zmerna do zelo zmerna, do okrevanja oz. izboljševanja pa je prišlo po prekinitvi odmerjanja.
From a microbiological point of view, the diluted solution should be used immediately.
Iz mikrobiološkega vidika je razredčeno raztopino treba uporabiti takoj.
During course (month) 6
Med ciklom (mesecem) 6
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V posamezni skupini pogostnosti so neželeni učinki predstavljeni po podajoči resnosti.
Data from 409 subjects participating in several neuroblastoma studies and having samples available for the determination of human anti-chimeric antibodies (HACA) demonstrated that 71 (17%) developed binding antibodies and 15 (4%) developed a neutralising antibody response.
Podatki 409 bolnikov, ki so sodelovali v številnih študijah o nevroblastomu in pri katerih so razpolagali z vzorci za določitev humanih antihimernih protiteles (HACA- human anti-chimeric antibodies), so pokazali, da jih je 71 (17 %) razvilo vezna protitelesa, 15 (4 %) pa odziv nevtraliziranja protiteles.
It is administered on Days 4-7 during Courses 1, 3, and 5 (each course lasting approximately 24 days) and on Days 8-11 during Courses 2 and 4 (each course lasting approximately 28 days).
Daje se od 4. do 7. dne med cikli 1,3 in 5 (vsak cikel traja približno 24 dni) in od 8. do 11. dne med cikloma 2 in 4 (vsak cikel traja približno 28 dni).
• IL-2 is given as a drip into one of your veins for four days in a row (continuous infustion) - for the first four days of the first week and the first four days of the second week of each course.
• IL-2 boste jemali v obliki kapalne infuzije v žilo štiri dni zaporedoma (kontinuirana infuzija) - prve štiri dni v prvem tednu in prve štiri dni v drugem tednu posameznega cikla.
If required for persistent pain, ibuprofen should be administered orally every 6 hours between doses of paracetamol.
Če bolečine ne popustijo, je treba dati peroralno ibuprofen vsakih 6 ur med odmerki paracetamola.
In this study, 27 children with high-risk neuroblastoma (age: 3.9 ± 1.9 years) received up to 5 cycles of Unituxin at 17.5 mg/m2/day as an intravenous infusion over 10 to 20 hours for 4 consecutive days every 28 days.
V tej študiji je 27 otrok z nevroblastomom z visokim tveganjem (starost 3,9 ± 1,9 let) prejelo do 5 ciklov zdravila Unituxin po 17,5 mg/m2/dan v obliki intravenske infuzije v času 10 do 20 ur, 4 zaporedne dni vsakih 28 dni.
Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures.
Zdravilo Unituxin je treba ukiniti, če bolečine ni mogoče primerno nadzorovati kljub zmanjšanju hitrosti infuzije in vzpostavitvi vseh podpornih ukrepov.
If hypotension occurs, this can be repeated, or intravenous albumin or packed red blood cells can be administered as clinically indicated.
Če pride do hipotenzije, se postopek lahko ponovi oz. se lahko da intravenski albumin ali pakirane eritrocite, kot je klinično indicirano.
Plasma concentrations of dinutuximab, especially trough levels, tended to be lower in patients with HACA.
Koncentracije dinutuksimaba v plazmi, še posebej tik pred naslednjim odmerkom, so bili nižji pri bolnikih s HACA.
Peripheral neuropathy Grade 2 peripheral motor neuropathy
Stopnja 2 periferna motorična nevropatija
In clinical trials, scheduled dinutuximab doses of up to 120 mg/m2 (60 mg/m2/day) have been administered with an adverse reaction profile similar to that described in section 4.8.
V kliničnih preskušanjih so bili aplicirani odmerki dinutuksimaba do 120 mg/m2 (60 mg/m2/dan), s profilom neželenih učinkov, podobnem tistemu, ki je opisan v poglavju 4.8.
What you need to know before you are given Unituxin 3.
Kaj morate vedeti, preden boste uporabili zdravilo Unituxin 3.
Systemic infection or sepsis Grade 3 or 4
Sistemska infekcija ali sepsa Stopnja 3 ali 4
Dinutuximab (or the murine monoclonal antibody 14.18) has been administered to mice, rabbits, rats, and dogs in single- or repeat-dose regimens that exceed the dose that is used clinically.
Dinutuksimab (oz. mišje monoklonsko protitelo 14.18) je bil apiciran mišim, kuncem, podganam in psom v posameznih odmerkih ali v ponavljajočih se odmerkih, ki presegajo klinično uporabljeni odmerek.
Dinutuximab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Biotransformacija Dinutuksimab je protein, katerega predvidena presnovna pot je razgraditev v majhne peptide in individualne aminokisline prek ubikvitarnih proteolitičnih encimov.
There is insufficient information on the excretion of dinutuximab in human milk.
Ni dovolj podatkov o izločanju dinutuksimaba v materino mleko.
• If symptoms resolve that day, resume the next day with premedication in the intensive care setting.
• Če simptomi izzvenijo tisti dan, naslednji dan ponovno začnite premedikacijo v intenzivni negi.
To reduce the risk of the cancer coming back, Unituxin is given at the last stage of the treatment to eliminate small amounts of disease which may still be present after the cancer has responded to chemotherapy, surgery, and an autologous (self-donating) blood cell transplant.
Za preprečevanje ponovnega pojava raka se zdravilo Unituxin daje v zadnji stopnji zdravljenja za uničenje ostankov bolezni, ki so morda še vedno prisotni po tem, ko se je rak odzval na kemoterapijo, kirurški poseg in avtologno presaditev (lastnih) krvnih celic.
Pre-medication should always be considered before starting each infusion (see section 4.4).
Pred začetkom posamezne infuzije je treba vedno upoštevati premedikacijo (glejte poglavje 4.4).
Immunoglobulin must not be given within two weeks before and one week after completing each course of Unituxin.
Imunoglobulina se ne sme dajati dva tedna pred in en teden po zaključku posameznega cikla z zdravilom Unituxin.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo, tudi če ste ga dobili brez recepta.
• Any kind of pain: in the stomach, throat, chest, face, hands, feet, legs or arms (such as numbness, tingling or burning) back, neck, joint, bone, muscle, mouth, eye, genitals.
• katere koli bolečine: v želodcu, grlu, prsih, na obrazu, dlaneh, stopalih, nogah ali rokah (na primer odrevenelost, mravljinčenje ali skelenje), hrbtu, v vratu, sklepu, kosteh, mišicah, ustih, očesu,
In addition, it has been shown to induce both antibody dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity in vitro.
Poleg tega je bilo dokazano, da povzroča bodisi od protiteles odvisno celično posredovano citotoksičnost (ADCC- antibody dependent cell-mediated cytotoxicity) bodisi od komplementa odvisno cititoksičnost in vitro.
Hence, this medicinal product is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravila ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
• Pain - tell your doctor or nurse if you get any pain.
• Bolečine - obvestite svojega zdravnika ali medicinsko sestro, če čutite bolečine.
It is recommended to administer oral metolazone or intravenous furosemide every 6-12 hours as required.
Priporoča se peroralno dajanje metolazona ali intravenskega furosemida vsakih 6-12 ur, če je potrebno.