FrancophonIA/ELRC3.0 huggingface dataset:
English: • Administer dinutuximab at 0.875 mg/m2/h and resume GM-CSF or IL-2.
Slovenian: • Aplicirajte 0,875 mg/m2/h dinutuksimaba in ponovno začnite z dajanjem GM-CSF ali IL-2.
English: Electrolyte abnormalities have been reported in patients who received Unituxin.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Unituxin, so se pojavile nenormalne vrednosti elektrolitov.
English: - higher risk of getting infections especially from the devices used to give you the medicine, blood or gut infections - skin problems where the injection was given, a red rash with small bumps - abnormal blood tests such as low levels of magnesium, glucose, high level of acids or creatinine.
Slovenian: - težave s kožo na mestu injiciranja, rdeč izpuščaj z majhnimi bulami - nenormalne vrednosti krvnih testov, na primer nizke ravni magnezija, glukoze ter visoke ravni kislin oziroma kreatinina
English: Each vial contains 17.5 mg of dinutuximab in 5 mL.
Slovenian: Ena viala vsebuje 17,5 mg dinutuksimaba v 5 ml.
English: • Delay course initiation until creatinine clearance or glomerular filtration rate (GFR) is at least 70 mL/min/1.73 m2 Systemic infection or sepsis
Slovenian: ni najmanj 70 ml/min/1,73 m2 Sistemska infekcija ali sepsa
English: 1 Includes preferred terms abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain, pain in extremity, and proctalgia.
Slovenian: 1 Vključuje priporočene izraze bolečine v trebuhu, bolečine v zgornjem delu trebuha, artralgija, bolečine v križu, bolečine v mehurju, bolečine v kosteh, bolečine v prsih, bolečine na obrazu, bolečine v dlesnih, mišično-kostne bolečine v prsnem košu, mialgija, bolečine v vratu, nevralgija, orofaringealne bolečine, bolečine, bolečine v okončinah in proktalgija.
English: Lidocaine infusion should be discontinued if the patient develops dizziness, perioral numbness, or tinnitus.
Slovenian: Infuzijo lidokaina je treba prekiniti, če bolnik kaže znake omotice,
English: Eye disorders may occur, especially with repeated courses.
Slovenian: Očesne bolezni se pojavijo zlasti pri ponovnem zdravljenju.
English: Adverse reactions are defined as those adverse events that occurred at a higher frequency in the dinutuximab, GMCSF, IL-2 and isotretinoin-treated group compared with the isotretinoin-treated control group during the ANBL0032 randomised, controlled, pivotal study, and that have a plausible mechanistic relationship to treatment with dinutuximab.
Slovenian: zdravljenih z dinutuksimabom, GM-CSF, IL-2 in izotretinoin, v primerjavi s kontrolno skupino, ki je bila zdravljena z izotretinoinom med randomizirano, kontrolirano osrednjo študijo ANBL0032, in ki so vzročno povezani z zdravljenjem z dinutuksimabom.
English: Pain Grade 4
Slovenian: Stopnja 4
English: • Reduce rate of infusion to 0.875 mg/m2/h.
Slovenian: • Znižajte hitrost infuzije na 0,875 mg/m2/h.
English: It is recommended that additional intravenous bolus doses of an opioid are administered as needed for treatment of pain up to once every 2 hours during the dinutuximab infusion.
Slovenian: Med infuzijo dinutuksimaba se priporoča dodatni intravenski bolus opioida po potrebi za lajšanje bolečin, do enkrat vsake dve uri.
English: • Start GM-CSF or IL-2 at 50 % of the dose when administered with dinutuximab.
Slovenian: • Začnite z dajanjem 50 % odmerka GM-CSF ali IL-2, če se daje skupaj z dinutuksimabom.
English: • If IL-2 is not tolerated at 50 % of the dose, substitute with GM-CSF for the remainder of the IL-2 courses.
Slovenian: • Če bolnik ne prenaša 50 % odmerka IL-2, ga zamenjajte z GM-CSF za preostali del cikla z IL-2.
English: • If symptoms recur, discontinue dinutuximab, GM-CSF, and IL-2 for remaining courses.
Slovenian: • Če se simptomi ponovno pojavijo, prekinite dinutuximab, GM-CSF in IL-2 za preostali cikel.
English: Onset of symptoms
Slovenian: Nastop simptomov
English: How to store Unituxin
Slovenian: Kako uporabljati zdravilo Unituxin
English: Adverse reactions reported for subjects receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin are summarised in Table 5.
Slovenian: Neželeni učinki pri bolnikih, zdravljenih z dinutuksimabom v kombinaciji z GM-CSF, IL-2 in izotretinoinom, so povzeti v Preglednici 5.
English: 1 mL of concentrate contains 3.5 mg of dinutuximab.
Slovenian: 1 ml koncentrata vsebuje 3,5 mg dinutuksimaba.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu., kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: • If symptoms recur with the addition of GM-CSF or IL-2 discontinue GM
Slovenian: • Če se simptomi ponovno pojavijo z dodajanjem GM-CSF ali IL-2,
English: Pain
Slovenian: Bolečine
English: The 3-year estimates of OS were 80 % compared with 67 % among subjects receiving dinutuximab immunotherapy plus isotretinoin and isotretinoin alone, respectively (log-rank test p = 0.0165).
Slovenian: Troletna ocena splošnega preživetja je bila 80 % pri bolnikih, zdravljenih z imunoterapijo z dinutuksimabom skupaj z izotretinoinom, v primerjavi s 67 % pri bolnikih, zdravljenih samo z izotretinoinom (log-rank test p = 0,0165).
English: The solution should be mixed by gentle inversion.
Slovenian: Raztopino pomešajte z nežnim obratom.
English: Unituxin 3.5 mg/mL concentrate for solution for infusion dinutuximab
Slovenian: Unituxin 3,5 mg/ml koncentrat za raztopino za infundiranje dinutuksimab
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium flip-off seal containing 5 mL of concentrate for solution for infusion.
Slovenian: Prozorna viala iz stekla tipa I z zamaškom iz bromobutilne gume in aluminijastim tesnilom »flip- off«.
English: Urinary retention, proteinuria, haematuria
Slovenian: Bolezni sečil zastoj urina, proteinurija, hematurija odpoved ledvic
English: How much is given
Slovenian: Koliko zdravila uporabiti
English: Table 4 provides dose modification guidance for dinutuximab, GM-CSF and IL-2.
Slovenian: V Preglednici 4 so navodila za prilagajanje odmerka zdravilnih učinkovin dinutuksimaba, GM-CSF in IL-2.
English: What Unituxin is
Slovenian: Kaj je zdravilo Unituxin
English: Leukopaenia
Slovenian: Levkopenija
English: • If capillary leak syndrome occurred during IL-2 course, substitute GM-CSF for remainder of IL-2 courses.
Slovenian: Poznejši cikel zdravljenja • Če se je sindrom kapilarnih razpok pojavil v med ciklom z IL-2, zamenjajte z GM-CSF za preostali del cikla z IL-2.
English: Respiratory dysfunction
Slovenian: Dihalne motnje
English: The 2-year estimates of EFS were 66 % among subjects receiving dinutuximab immunotherapy plus isotretinoin as compared with 48 % in subjects receiving isotretinoin alone (log-rank test p = 0.033) although this difference did not reach formal statistical significance according to the pre-specified plan for interim analyses.
Slovenian: Dvoletna ocena EFS je bila 66 % pri bolnikih, zdravljenih z imunoterapijo z dinutuksimabom skupaj z izotretinoinom, v primerjavi z 48 % pri bolnikih, zdravljenih samo z izotretinoinom (log-rank test p = 0,033),
English: increase the dinutuximab infusion to 1.75 mg/m2/h.
Slovenian: CSF ali IL-2, povečajte infuzijo dinutuksimaba do 1,75 mg/m2/h.
English: Polysorbate 20 (E 432)
Slovenian: 6.1 Seznam pomožnih snovi histidin polisorbat 20 (E 432) natrijev klorid voda za injiciranje
English: • If GM-CSF is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the GM-CSF courses.
Slovenian: • Če bolnik ne prenaša 50 % odmerka GM-CSF, dajajte samo dinutuksimab za preostali del cikla z GM-CSF.
English: Table 4: Dose modification guidance for the management of treatment-emergent adverse reactions during administration of dinutuximab in combination with GM-CSF, IL-2 and isotretinoin.
Slovenian: Preglednica 4: Navodila za prilagajanje odmerka za obvladovanje z zdravljenjem povezanih neželenih učinkov med dajanjem dinutuksimaba v povezavi z GM-CSF, IL-2 in izotretinoinom.
English: What Unituxin is used for
Slovenian: Za kaj uporabljamo zdravilo Unituxin
English: Each mL of concentrate contains 3.5 mg of dinutuximab.
Slovenian: En ml koncentrata vsebuje 3,5 mg dinutuksimaba.
English: • If IL-2 is not tolerated at 50 % of the dose, administer dinutuximab alone
Slovenian: • Če bolnik ne prenaša 50 % odmerka IL-2, dajte samo dinutuksimab za
English: Serum sickness Grade 4 (life-threatening)
Slovenian: Stopnja 4 (življenje ogrožajoča)
English: Uncommon side effects (may affect up to 1 in 100 people ): - unequal pupils - fluid in or around the lungs - kidney failure - over-active thyroid - serum sickness - an illness similar to an allergy - abnormal heart rhythm - swelling in the back part of the brain (Posterior Reversible Encephalopathy Syndrome) - symptoms may include high blood pressure, headache, fits, change in vision or behaviour, feeling drowsy or tired.
Slovenian: - serumska bolezen - bolezen, podobna alergiji - nepravilni srčni utrip - zatekanje zadnjega dela možganov (sindrom posteriorne reverzibilne encefalopatije) - simptomi lahko vključujejo visok krvni tlak, glavobol, epileptične napade, motnje vida in vedenja, dremavost oziroma utrujenost - atipični hemolitično uremični sindrom (aHUS) - bolezen, ki prizadene krvni sistem in ledvice simptomi lahko vključujejo trdovratne simptome podobne gripi, zmedenost, letargijo, izgubo apetita ali urin temne barve.
English: Intravenous use after dilution
Slovenian: Za intravensko uporabo po razredčitvi.
English: • If symptoms recur, discontinue dinutuximab, GM-CSF, and IL-2 for
Slovenian: • Če se simptomi ponovno pojavijo, prekinite dinutuximab, GM-CSF in
English: Description of selected adverse reactions
Slovenian: Opis nekaterih neželenih učinkov
English: Store and transport refrigerated (2°C - 8°C).
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte in prenašajte na hladnem (2-8 °C).
English: 2/day; for body weight up to 12 kg: 2.67 mg/kg administered orally twice daily for a total daily dose of 160 mg/m
Slovenian: 3. izotretinoin: za telesno maso večjo od 12 kg: 80 mg/m2, ki se daje peroralno dvakrat na dan v skupnem odmerku 160 mg/m2/dan; za telesno maso do 12 kg: 2,67 mg/kg, ki se daje peroralno dvakrat na dan v skupnem odmerku 5,33 mg/kg/dan (odmerek zaokrožite na 10 mg).
English: • Discontinue dinutuximab and GM-CSF or IL-2 for that day.
Slovenian: • Prekinite dinutuksimab in GM-CSF ali IL-2 za tisti dan.
English: THE MEDICINAL PRODUCT
Slovenian: FARMACEVTSKI PODATKI
English: Infusion reactions generally occurred during or within 24 hours of completing the Unituxin infusion.
Slovenian: Infuzijske reakcije so se običajno pojavile med infundiranjem zdravila
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: • For GM-CSF courses, administer GM-CSF at 50 % of the dose starting the next day, and if tolerated, GM-CSF may be given at full dose after completing dinutuximab dosing for that course.
Slovenian: • Za cikle zdravljenja z GM-CSF, aplicirajte 50 % odmerka GM-CSF, začenši z naslednjim dnem.
English: • Resume dinutuximab infusion at 0.875 mg/m2/h.
Slovenian: • Ponovno začnite z dajanjem infuzije dinutuksimaba po 0,875 mg/m2/h.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: • Delay course initiation until CNS toxicity is Grade 1 or resolved and/or seizure disorder is well controlled Hepatic dysfunction
Slovenian: Toksični učinek na osrednji živčni sistem • Odložite začetek cikla zdravljenja, dokler toksični učinek na osrednji živčni sistem ni stopnje 1 ali odpravljen in/ali so epileptični napadi pod kontrolo.
English: hypertension
Slovenian: Hiponatremija
English: Device-related infection, infection susceptibility increased, bacteraemia, enterocolitis
Slovenian: Infekcije in parazitske bolezni okužba, povezana z medicinskimi pripomočki, večja občutljivost za okužbe,
English: Grade 1 or 2
Slovenian: Alergijske reakcije Stopnja 1 ali 2
English: Electrolyte abnormalities occurring in at least 25 % of patients who received Unituxin included hyponatraemia and hypokalaemia.
Slovenian: Nenormalne vrednosti laboratorijskih testov Nenormalne vrednosti elektrolitov so se pojavile pri najmanj 25 % bolnikov, ki so prejemali zdravilo
English: Febrile neutropenia
Slovenian: Periferna nevropatija
English: • Proceed with subsequent planned dinutuximab and GM-CSF or IL-2 courses.
Slovenian: • Nadaljujte z naslednjimi predvidenimi cikli dinutuksimaba in GM-CSF ali IL-2.
English: A population pharmacokinetic analysis conducted on all clinical data available suggests that the disposition of dinutuximab is not altered by age, race, gender, concomitant medications (IL-2, GM-CSF) and the presence of capillary leak syndrome, renal or hepatic impairment.
Slovenian: Farmakokinetična populacijska analiza, ki zajema vse klinično dosegljive podatke, kaže da starost, rasa, spol,
English: Elimination
Slovenian: Po odpravi
English: Sodium chloride
Slovenian: Vsebnost natrija
English: Unituxin 3.5 mg/mL concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Unituxin 3,5 mg/ml koncentrat za raztopino za infundiranje
English: Hypomagnesaemia, acidosis, hypoglycaemia,
Slovenian: Unituxin, vključno s hiponatremijo in hipokalemijo.
English: • Discontinue dinutuximab, GM-CSF, and IL-2 for remaining courses.
Slovenian: • Prekinite dinutuksimab, GM-CSF in IL-2 za preostali del cikla.
English: • You should not breastfeed during treatment with this medicine.
Slovenian: • Ker ni podatkov o prehajanju zdravila v materino mleko, med dojenjem zdravila Unituxin ne smete jemati.
English: Recurrence
Slovenian: Ponovni pojav
English: Refer to section 4.4 for actions to be taken for specific adverse reactions.
Slovenian: Glede ukrepov v primeru določenih neželenih učinkov glejte poglavje 4.4.
English: Diarrhoea, vomiting, nausea
Slovenian: Bolezni prebavil diareja, bruhanje, navzea zaprtost, krvavitve iz spodnjih prebavil
English: Intravenous sodium chloride 9 mg/mL (0.9%) solution for injection (10 mL/kg) should be administered over one hour just prior to the dinutuximab infusion.
Slovenian: Hipotenzija Tik pred infuzijo dinutuksimaba je treba dati injekcijo (10 ml/kg) natrijevega klorida 9 mg/ml (0,9 %)
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja uritikarija, pruritus makulopapulozni izpuščaj
English: Neuralgia, peripheral neuropathy, headache
Slovenian: Bolezni živčevja nevralgija, periferna nevropatija, glavobol sindrom posteriorne reverzibilne encefalopatije
English: • Discontinue dinutuximab and GM-CSF or IL-2 for that course.
Slovenian: • Prekinite dinutuksimab in GM-CSF ali IL-2 za ta cikel.
English: Then increase to full dose if tolerated for the remainder of
Slovenian: Če ga bolnik prenaša, povišajte do celotnega odmerka
English: For shelf life after dilution, see section 6.3.
Slovenian: Glede časa shranjevanja pripravljene raztopine glejte poglavje 6.3.
English: Endocrine disorders
Slovenian: Bolezni endokrinega sistema hipertiroidizem
English: • Discontinue dinutuximab and intravenous GM-CSF or IL-2.
Slovenian: • Prekinite dinutuksimab in intravensko dajanje GM-CSF ali IL-2.
English: GM-CSF for remainder of IL-2 courses.
Slovenian: IL-2 za preostali cikel.
English: • Discontinue dinutuximab and GM-CSF or IL-2 for remainder of course.
Slovenian: • Prekinite dinutuksimab in GM-CSF ali IL-2 za preostali del cikla.
English: • If capillary leak syndrome occurred during GM-CSF course, administer dinutuximab alone for subsequent GM-CSF courses.
Slovenian: • Če se je sindrom kapilarnih razpok pojavil med ciklom z GM-CSF,
English: • Discontinue dinutuximab and GM-CSF or IL-2.
Slovenian: • Prekinite dinutuksimab in GM-CSF ali IL-2.
English: • Any kind of allergic reaction or other reaction at the injection site - symptoms may include a skin rash, hives, swelling in the face or throat, dizziness, a rapid heart beat or palpitations, being short of breath and difficulty breathing, fever, feeling sick, aches and pains in your joints .
Slovenian: Nemudoma obvestite svojega zdravnika ali medicinsko sestro, če se pojavi kateri koli od naslednjih simptomov: • katera koli alergijska ali druga reakcija na mestu injiciranja - simptomi lahko vključujejo kožni izpuščaj, urtikarijo, otekline obraza ali grla, omotico, pospešen srčni utrip ali palpitacije,
English: Respiratory, thoracic and mediastinal disorders
Slovenian: bakteriemija, enterokolitis
English: If tolerated, increase GM-CSF or
Slovenian: Liza celic se je povečala z dodatkom GM-CSF.
English: Unituxin 3.5 mg/mL sterile concentrate dinutuximab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Unituxin 3,5 mg/ml sterilni koncentrat dinutuksimab
English: Cytokine release syndrome
Slovenian: sindrom sproščanja serumska bolezen
English: • Permanently discontinue dinutuximab and GM-CSF or IL-2.
Slovenian: • Dokončno prekinite dinutuksimab in GM-CSF ali IL-2.
English: Capillary leak syndrome, hypotension,
Slovenian: Srčne bolezni tahikardija (sinusna,
English: • If BP remains stable for at least 2 hours after resuming GM-CSF or IL-2,
Slovenian: • Če krvni tlak ostane stabilen najmanj 2 uri po ponovnem dajanju GMCSF ali IL-2, povečajte infuzijo dinutuksimaba do 1,75 mg/m2/h.
English: • If GM-CSF is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the course.
Slovenian: • Če bolnik ne prenaša 50 % odmerka GM-CSF, dajte samo dinutuksimab
English: • Resume dinutuximab at 0.875 mg/m2/h once BP is stable.
Slovenian: • Ponovno začnite z dajanjem dinutuksimaba po 0,875 mg/m2/h, ko je
English: Bronchospasm, pulmonary oedema
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora bronhospazem, pljučni edem stridor, edem grla
English: Your name:
Slovenian: Vaše ime:
English: Doctor's phone number:
Slovenian: Telefonska številka zdravnika:
English: At present it is not known whether this is clinically relevant.
Slovenian: Trenutno ni znano, ali je to klinično pomembno.
English: Population (Number)
Slovenian: Populacija (Število)
English: 28108 Madrid SPAIN
Slovenian: 28108 Madrid ŠPANIJA
English: Active tuberculosis should also be ruled out.
Slovenian: Prav tako je treba izključiti aktivno tuberkulozo.
English: The guide for healthcare professionals shall contain the following key elements:
Slovenian: Vodič za zdravstvene delavce mora vsebovati naslednje ključne elemente:
English: Nausea was most frequent during the first 2 weeks of treatment.
Slovenian: Navzea se je najpogosteje pojavljala v prvih 2 tednih zdravljenja.
English: c Includes changes detected during laboratory monitoring (see text below).
Slovenian: c Vključuje spremembe, zaznane med laboratorijskim spremljanjem (glejte spodnje besedilo).
English: You can take the tablets either with or without food.
Slovenian: Tablete lahko jemljete skupaj s hrano ali brez nje.
English: Doctor's name (who prescribed Olumiant):
Slovenian: Ime zdravnika (ki je predpisal zdravilo Olumiant):
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first Authorisation: 13 February 2017
Slovenian: Datum prve odobritve: 13. februar 2017
English: If the medicine is working well, your doctor may decide the dose can be reduced.
Slovenian: Če zdravilo ustrezno deluje, se bo vaš zdravnik morda odločil, da je odmerek mogoče znižati.
English: Other intrinsic Factors
Slovenian: Drugi intrinzični dejavniki
English: Olumiant is to be taken once daily with or without food and may be taken at any time of the day.
Slovenian: Zdravilo Olumiant se jemlje enkrat na dan s hrano ali brez nje in se ga lahko jemlje v katerem koli času dneva.
English: The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Olumiant pri otrocih in mladostnikih, starih od 0 do 18 let, še nista bili dokazani.
English: All patients who completed these studies were eligible to enrol in a long term extension study for up to 4 years continued treatment.
Slovenian: Vsi bolniki, ki so zaključili te študije, so se lahko vključili v dolgoročno podaljšano študijo za največ 4 leta nadaljevalnega zdravljenja.
English: The majority of these patients (n = 94) were co-treated with methotrexate.
Slovenian: Večina teh bolnikov (n = 94) je bila sočasno zdravljena z metotreksatom.
English: Table 4: Response, Remission and Physical Function Study
Slovenian: Preglednica 4: Odziv, remisija in telesna zmogljivost Študija
English: There was no change in the LDL/HDL ratio.
Slovenian: Sprememb v razmerju LDL/HDL ni bilo.
English: See section 4.2 for dose recommendations.
Slovenian: Glejte poglavje 4.2 za priporočila o odmerjanju.
English: Keep this information with you and share it with other healthcare professionals involved in your medical care or treatment.
Slovenian: Te informacije imejte pri sebi in jih pokažite vsem zdravstvenim delavcem, ki so vključeni v vašo zdravstveno oskrbo ali zdravljenje.
English: You should swallow your tablet with a drink of water.
Slovenian: Tableto morate pogoltniti z nekaj vode.
English: These effects can help you to do normal daily activities and so improve the health-related quality of life for patients with rheumatoid arthritis.
Slovenian: Ti učinki vam lahko pomagajo opravljati vaše običajne vsakodnevne dejavnosti in na ta način izboljšati z zdravjem povezano kakovost življenja bolnikov z revmatoidnim artritisom.
English: These could be symptoms of tuberculosis (an infectious disease of the lungs).
Slovenian: To so lahko simptomi tuberkuloze (infekcijske bolezni pljuč).
English: What Olumiant is and what it is used for
Slovenian: Kaj je zdravilo Olumiant in za kaj ga uporabljamo
English: Olumiant is not for use in children and adolescents under 18 years old because there is no information on use in this age group.
Slovenian: Zdravilo Olumiant ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let, saj ni na voljo nobenih informacij o uporabi v tej starostni skupini.
English: Your doctor may give you a lower dose of 2 mg once a day, particularly if you are over 75 years old or if you have an increased risk of infections.
Slovenian: Vaš zdravnik vam lahko predpiše manjši odmerek 2 mg enkrat na dan, še posebej, če ste starejši od 75 let ali če pri vas obstaja povečano tveganje za okužbe.
English: Most cases were transient and did not require treatment discontinuation.
Slovenian: Večina primerov je bila prehodnih in zaradi njih ni bilo treba prekiniti zdravljenja.
English: The overall incidence rate of serious infections in the clinical trial programme was 3.2 per 100 patient-years.
Slovenian: Skupna incidenca resnih okužb v programu kliničnega preskušanja je bila 3,2 na 100 bolnikovih let.
English: This document contains important information you should be aware of before and during treatment with Olumiant.
Slovenian: Ta dokument vsebuje pomembne informacije, ki jih morate poznati pred in med zdravljenjem z zdravilom Olumiant.
English: Olumiant can be used alone or together with some other medicines, such as methotrexate.
Slovenian: Zdravilo Olumiant lahko uporabljamo samo ali pa skupaj z nekaterimi drugimi zdravili, kot je npr. metotreksat.
English: - if you are pregnant or think you may be pregnant.
Slovenian: - če ste noseči ali menite, da bi lahko bili noseči.
English: Radiographic Changes
Slovenian: Radiografske spremembe
English: In July 2019 VTE reporting rate was 0,13% compared to 0,09% in February 2019.
Slovenian: Julija 2019 je bila pogostnost poročil o VTE 0,13 %, februarja 2019 pa 0,09%.
English: Patients over 18 years of age were eligible to participate.
Slovenian: Za sodelovanje so bili primerni bolniki, starejši od 18 let.