FrancophonIA/ELRC3.0 huggingface dataset:
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Slovenian: To mora vključevati kolonoskopijo in biopsije v skladu z lokalnimi priporočili.
English: Always take the outer carton and this leaflet with you, even if it is empty.
Slovenian: S seboj vedno vzemite to navodilo in škatlo, tudi če je prazna.
English: It should be noted that in the majority of these reports, tuberculosis was extrapulmonary presenting as either local or disseminated disease.
Slovenian: Poudariti je treba, da je bila v večini teh poročil tuberkuloza izven pljuč in je nastopila bodisi v obliki lokalne ali diseminirane bolezni.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Slovenian: Periodično pregledovanje kože se priporoča za vse bolnike, predvsem pa za tiste z dejavniki tveganja za kožnega raka.
English: • Improve your physical function.
Slovenian: • za izboljšanje telesne sposobnosti.
English: Corticosteroids were to be tapered at the start of the maintenance study.
Slovenian: Odmerke kortikosteroidov je bilo treba postopoma zmanjšati ob začetku vzdrževalne študije.
English: The effects of this medicine in pregnant women are not known.
Slovenian: Učinki tega zdravila pri nosečnicah niso znani.
English: Ulcerative colitis • The table below shows how you will usually use this medicine.
Slovenian: Ulcerozni kolitis • Spodnja preglednica prikazuje, kako boste običajno uporabljali to zdravilo.
English: • Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
Slovenian: • huda okužba po celem telesu (sepsa), včasih vključno z nizkim krvnim tlakom (septični šok),
English: It is used in adults for the treatment of the following inflammatory diseases:
Slovenian: Uporablja se pri odraslih ljudeh za zdravljenje naslednjih vnetnih bolezni:
English: Result _______________ • Tell your doctor if you know or suspect you are a carrier of the hepatitis B virus.
Slovenian: Rezultat _______________ • Zdravniku povejte, če veste ali sumite, da ste prenašalec virusa hepatitisa B.
English: It is not known whether this finding was due to effects on the males and/or the females.
Slovenian: Ni znano, ali je bil ta izsledek posledica učinkov zdravila na samce in/ali na samice.
English: All treated population (AT)
Slovenian: Populacija vseh zdravljenih (AT)
English: The potential risk with the combination of AZA or 6-MP and golimumab should be carefully considered.
Slovenian: Možno tveganje kombinirane uporabe AZA ali 6-MP in golimumaba je treba skrbno pretehtati.
English: Component of a multipack, cannot be sold separately
Slovenian: Del večkratnega pakiranja, se ne sme izdajati ločeno.
English: When to inject your next dose:
Slovenian: Kdaj injicirati naslednji odmerek:
English: • reactivation of hepatitis B virus if you are a carrier or have had hepatitis B before (rare).
Slovenian: • reaktivacijo virusa hepatitisa B, če ste prenašalec ali ste v preteklosti imeli hepatitis B (redko).
English: Show this card to any doctor involved in your treatment.
Slovenian: Kartico pokažite vsem zdravnikom, ki sodelujejo pri vašem zdravljenju.
English: Use of live vaccines could result in clinical infections, including disseminated infections.
Slovenian: Uporaba živih cepiv bi lahko povzročila klinične okužbe, vključno z razsejanimi okužbami.
English: This will cause any air bubbles to rise to the top.
Slovenian: To bo povzročilo, da se bodo zračni mehurčki dvignili na površje.
English: After you remove the air bubbles, you may see a line inside the viewing window.
Slovenian: Po odstranitvi zračnih mehurčkov boste v prikazovalnem okencu morda videli črto.
English: EXP EXP, if stored at room temperature___________________
Slovenian: EXP EXP na sobni temperaturi___________________
English: Pregnancy and vaccinations
Slovenian: Nosečnost in cepljenja
English: It is normal to see some drug still visible in the viewing window.
Slovenian: Normalno je, da boste v prikazovalnem okencu še vedno videli nekaj zdravila.
English: • If you are allergic (hypersensitive) to golimumab or any of the other ingredients of this medicine (listed in Section 6).
Slovenian: • če ste alergični (preobčutljivi) na golimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: The Patient Reminder Card shall contain the following key messages:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednja pomembna sporočila:
English: DO NOT press the button at this time.
Slovenian: Gumba v tem trenutku NE pritiskajte.
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Slovenian: Pomembno je, da vi in zdravnik zabeležita ime in številko serije vašega zdravila.
English: Wash your hands well with soap and warm water.
Slovenian: Dobro si umijte roke z milom in toplo vodo.
English: • If you have tuberculosis (TB) or any other severe infection.
Slovenian: • če imate tuberkulozo (TB) ali katero koli drugo hudo okužbo;
English: No dose adjustment is required in the elderly.
Slovenian: Pri starejših ni potrebna prilagoditev odmerka.
English: The number of patients with other PsA subtypes was too small to allow meaningful assessment.
Slovenian: Število bolnikov z drugimi podvrstami psoriatičnega artritisa pa je bilo premajhno, da bi omogočilo smiselno oceno.
English: Do not touch the needle or allow it to touch any surface.
Slovenian: Ne dotaknite se igle in tudi ne dovolite, da bi se igla dotaknila katere koli površine.
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Slovenian: Ta ocena mora vključevati podrobno zdravstveno anamnezo z osebno anamnezo glede tuberkuloze ali morebitnih predhodnih stikov s tuberkulozo in predhodnim in/ali sedanjim imunosupresivnim zdravljenjem.
English: • Positive blood lupus test
Slovenian: • pozitiven izvid krvnih preiskav za lupus,
English: In this study, the type and frequency of adverse events reported were generally similar to those seen in adult RA studies.
Slovenian: V tej študiji sta bila tip in pogostnost poročanih neželenih učinkov na splošno podobna tistima iz študij RA pri odraslih.
English: Your doctor will test you to see if you have TB.
Slovenian: Zdravnik bo opravil preiskave, da bo ugotovil, ali imate TB.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Slovenian: Med vzdrževalnim zdravljenjem je mogoče odmerke kortikosteroidov postopoma zmanjšati v skladu s smernicami za klinično prakso.
English: • Bacterial infections (such as cellulitis)
Slovenian: • bakterijske okužbe (kot je celulitis),
English: However, if you prefer, you may pinch the skin to create a firmer surface for your injection (Figure 5b).
Slovenian: Če pa vam je ljubše, lahko stisnete kožo, da dobite čvrstejšo površino za injiciranje (slika 5b).
English: Hepatitis B virus (HBV)
Slovenian: Virus hepatitisa B (HBV)
English: In these instructions:
Slovenian: Navodila vsebujejo:
English: Before you begin using this pre-filled pen, you should know how to:
Slovenian: Pred začetkom uporabe tega napolnjenega injekcijskega peresnika, morate vedeti, kako:
English: No dose recommendations can be made.
Slovenian: Priporočil za odmerjanje ni mogoče podati.
English: For all of the endpoints described above, statistically significant results were also demonstrated in the OSI population at week 16.
Slovenian: Za vse zgoraj opisane opazovane dogodke so bili v 16. tednu rezultati statistično značilni tudi v populaciji OSI.
English: The stated reasons for discontinuation of prior anti TNF therapies were lack of efficacy (58%), intolerance (13%), and/or reasons other than safety or efficacy (29%, mostly for financial reasons).
Slovenian: Navedeni razlogi za ukinitev predhodne terapije z zaviralci TNF so bili nezadostna učinkovitost (58 %), neprenašanje zdravila (13 %) in drugi razlogi poleg varnosti ali učinkovitosti (29 %, večinoma iz finančnih razlogov).
English: Do not use the 5-centimetre area around your belly-button.
Slovenian: Ne uporabite 5-centimetrskega predela okrog popka.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Zaradi boljše sledljivosti bioloških zdravil morata biti jasno zabeležena ime in serijska številka prejetega zdravila.
English: • allergic reactions which may be serious, or rarely, life-threatening (rare).
Slovenian: • alergijske reakcije, ki so lahko resne ali v redkih primerih življenjsko nevarne (redko).
English: In this case you will get training on how to inject Simponi.
Slovenian: V tem primeru boste deležni usposabljanja o tem, kako injicirati zdravilo Simponi.
English: Tell your doctor straight away if you notice any of the above symptoms.
Slovenian: Nemudoma obvestite zdravnika, če opazite katerega koli od zgoraj navedenih simptomov.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
English: • Reduce the signs and symptoms of your disease.
Slovenian: • za ublažitev znakov in simptomov bolezni,
English: There are no adequate data on the use of golimumab in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi golimumaba pri nosečnicah.
English: N = number of patients ** p ≤ 0.001 * p ≤ 0.01
Slovenian: N = število bolnikov ** p ≤ 0,001 * p ≤ 0,01
English: The systemic clearance of golimumab was estimated to be 6.9  2.0 mL/day/kg.
Slovenian: Sistemski očistek golimumaba so ocenili na 6,9 ± 2,0 ml/dan/kg.
English: • Provision to record the type, date, and result of TB screenings.
Slovenian: • Prostor za beleženje vrste, datuma in rezultata presejalnih testov na TB.
English: If the yellow indicator is not shown in the window, the plunger has not advanced adequately, and the injection has not occurred.
Slovenian: Če rumeni kazalnik ni viden v okencu, se bat ni ustrezno sprožil in do injiciranja ni prišlo.
English: • You usually inject the medicine into the front of the middle thighs.
Slovenian: • Zdravilo si običajno injicirate v sprednji srednji del stegna.
English: Patients taking TNF-blockers are more susceptible to serious infections.
Slovenian: Bolniki, ki jemljejo zaviralce TNF, so bolj občutljivi za resne okužbe.
English: You must not be treated with Simponi if you have tuberculosis (TB) or any other severe infection.
Slovenian: Zdravila Simponi ne smete prejemati, če imate tuberkulozo (TB) ali katero koli drugo hudo okužbo.
English: Concurrent use with other biological therapeutics
Slovenian: Sočasna uporaba z drugimi biološkimi zdravili
English: At week 14, 28% of these patients achieved response defined by partial Mayo score (decreased by ≥ 3 points compared with start of induction).
Slovenian: V 14. tednu je 28 % teh bolnikov doseglo odziv, opredeljen z delno oceno Mayo (znižanje za ≥ 3 točke v primerjavi z začetkom indukcije).
English: Simponi must be discarded if not used within the 30 days of room temperature storage.
Slovenian: Zdravilo Simponi je treba zavreči, če se ga ne uporabi znotraj 30 dni shranjevanja na sobni temperaturi.
English: All patients had a history of heavy smoking.
Slovenian: Vsi ti bolniki so imeli v anamnezi strastno kajenje.
English: • You are pregnant or are planning to become pregnant while using Simponi.
Slovenian: • če ste noseči ali načrtujete nosečnost med uporabo zdravila Simponi.
English: Infections may progress more rapidly and may be more severe.
Slovenian: Okužbe lahko napredujejo hitreje in so lahko hujše.
English: Injecting without pinching the skin is recommended (Figure 5a).
Slovenian: Priporočeno je injiciranje brez stiskanja kože (slika 5a).
English: Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka ali ploda, porod ali poporodni razvoj (glejte poglavje 5.3).
English: Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Slovenian: Aktivna tuberkuloza (TB) ali druge hude okužbe, kot je sepsa, ter oportunistične okužbe (glejte poglavje 4.4).
English: • Infections may progress more rapidly and may be more severe.
Slovenian: • Okužbe lahko napredujejo hitreje in so lahko hujše.
English: Neurological events
Slovenian: Nevrološki dogodki
English: In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment be instituted immediately.
Slovenian: V primeru prevelikega odmerjanja se priporoča, da se bolnika spremlja glede kakršnih koli znakov ali simptomov neželenih učinkov in se mu nemudoma uvede ustrezno simptomatično zdravljenje.
English: • Wash your hands thoroughly with soap and warm water.
Slovenian: • Temeljito si umijte roke z milom in toplo vodo.
English: After proper training in subcutaneous injection technique, patients may self-inject if their physician determines that this is appropriate, with medical follow-up as necessary.
Slovenian: Po ustreznem usposabljanju o tehniki subkutanega injiciranja, si lahko bolniki zdravilo injicirajo sami, če njihov zdravnik presodi, da je to primerno, po potrebi tudi pod zdravniškim nadzorom.
English: Because latex may cause severe allergic reactions, talk to your doctor before using Simponi if you or your carer are allergic to latex.
Slovenian: Ker lahko lateks povzroči hude alergijske reakcije, se pred uporabo zdravila Simponi posvetujte z zdravnikom, če ste vi ali vaš skrbnik alergični na lateks.
English: • While you are waiting you can get the rest of your equipment ready, including an alcohol swab,
Slovenian: • Med čakanjem si lahko pripravite vse ostale potrebščine, vključno z alkoholnim zložencem,
English: This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Slovenian: Ta beljakovina sodeluje pri vnetnih procesih v telesu in lahko z njenim zaviranjem zmanjšamo vnetje v telesu.
English: The concomitant use of golimumab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Slovenian: Sočasna uporaba golimumaba s temi biološkimi zdravili ni priporočljiva zaradi možnosti povečanega tveganja za okužbe in drugih potencialnih farmakoloških interakcij.
English: If this happens, do not drive or use any tools or machines.
Slovenian: Če se vam to zgodi, ne vozite ali uporabljajte orodij ali strojev.
English: At week 54, the clinical outcomes observed in these patients were similar to the clinical outcomes reported for the patients achieving clinical response at week 6.
Slovenian: V 54. tednu so bili klinični izidi, ki so jih opazili pri teh bolnikih, podobni kliničnim izidom, ki so jih poročali pri bolnikih, ki so dosegli klinični odziv v 6. tednu.
English: • Tell your doctor or pharmacist if you are taking any other medicines that affect your immune system.
Slovenian: • Obvestite zdravnika ali farmacevta, če jemljete katera koli druga zdravila, ki vplivajo na vaš imunski sistem.
English: ASAS Partial Remission ASDAS-C
Slovenian: ASAS delna remisija ASDAS-C
English: The orange priming band will disappear.
Slovenian: Oranžen pas bo izginil.
English: The radiographic effects observed at week 52 were maintained through week 104.
Slovenian: Tudi radiografski učinki, ki so jih ugotovili v 52. tednu, so se ohranili do 104. tedna.
English: Talk to your child's doctor regarding vaccinations for your child.
Slovenian: O cepljenjih vašega otroka se posvetujte z otrokovim zdravnikom.
English: It is not known if golimumab treatment influences the risk for developing dysplasia or colon cancer.
Slovenian: Ni znano, ali zdravljenje z golimumabom vpliva na tveganje za nastanek displazije ali raka kolona.
English: The results of the maintenance study (PURSUIT-Maintenance) were based on evaluation of 456 patients who achieved clinical response from previous induction with Simponi.
Slovenian: Rezultati vzdrževalne študije (PURSUIT-Maintenance) so temeljili na oceni 456 bolnikov, ki so med predhodno indukcijo z zdravilom Simponi dosegli klinični odziv.
English: An effect on serum golimumab concentrations was seen at titres of > 1:100 while an effect on efficacy was not seen until titres of > 1:1000, though the numbers of children with titres of > 1:1000 were low (N = 8).
Slovenian: Vpliv na serumske koncentracije golimumaba je bil viden pri titrih > 1:100, medtem ko vpliva na učinkovitost ni bilo opaziti do titrov > 1:1.000, čeprav je bilo število otrok s titri > 1:1.000 majhno (N = 8).
English: Patients should be instructed not to inject a double dose to make up for the forgotten dose.
Slovenian: Bolnikom je treba naročiti, naj si ne injicirajo dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
English: Tell your doctor if you develop symptoms of a disease called lupus.
Slovenian: Obvestite zdravnika, če se vam pojavijo simptomi bolezni, imenovane lupus.
English: The role of golimumab as a contributing or aggravation factor cannot be excluded.
Slovenian: Vloge golimumaba kot dejavnika, ki dodatno prispeva k takemu stanju ali ga poslabša, pri tem dogodku ni mogoče izključiti.
English: Call your doctor, nurse or pharmacist to talk about any questions you may have.
Slovenian: Pokličite zdravnika, medicinsko sestro ali farmacevta, da se boste pogovorili o morebitnih vprašanjih.
English: Table 7 Key efficacy outcomes from PURSUIT - Induction and PURSUIT - Maintenance PURSUIT-Induction
Slovenian: Preglednica 7 Ključni izidi učinkovitosti iz študij PURSUIT - Induction in PURSUIT - Maintenance PURSUIT-Induction
English: Some patients may experience serious side effects and may require treatment.
Slovenian: Pri nekaterih bolnikih se lahko pojavijo resni neželeni učinki, ki lahko potrebujejo zdravljenje.
English: Remove air bubbles*
Slovenian: Odstranite zračne mehurčke*
English: Vaccinations Talk to your doctor if you have had, or are due to have a vaccine.
Slovenian: Cepljenja Posvetujte se z zdravnikom, če ste bili ali morate biti cepljeni.
English: • Once the button is pressed, it will remain pressed in so you do not need to keep pressure on it.
Slovenian: • Ko ste enkrat pritisnili na ta gumb, ga ne bo treba več pritiskati, ker bo ostal v takem položaju.
English: • Tell your doctor if you have an infection.
Slovenian: • Zdravniku povejte, če imate okužbo.
English: • Children weighing less than 40 kg: The recommended dose of Simponi for children weighing less than 40 kg depends on their weight and height.
Slovenian: • Otroci, ki tehtajo manj kot 40 kg: Priporočeni odmerek zdravila Simponi za otroke, ki tehtajo manj kot 40 kg, je odvisen od njihove telesne mase in višine.
English: In addition to the primary endpoint(s), additional assessments of the impact of Simponi treatment on the signs and symptoms of arthritis, radiographic response, physical function and health-related quality of life were performed.
Slovenian: Poleg določitve primarnega končnega rezultata(ov) so opravili tudi dodatne ocene vpliva zdravljenja z zdravilom Simponi na znake in simptome artritisa, radiografski odziv, telesno funkcijo in z zdravjem povezano kakovost življenja.
English: For more information on sorbitol (E420), see Section 2.
Slovenian: Za več informacij glede sorbitola (E420) glejte poglavje 2.
English: • Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor
Slovenian: • nenormalni izvidi jetrnih testov (zvišanje vrednosti jetrnih encimov), ugotovljeni s krvnimi preiskavami, ki jih opravi zdravnik,
English: Throughout this section, median duration of follow-up (approximately 4 years) is generally presented for all golimumab use.
Slovenian: V tem poglavju je mediano trajanje spremljanja bolnikov (približno 4 leta) na splošno predstavljeno za vse načine uporabe golimumaba.
English: The combination of golimumab and abatacept is not recommended.
Slovenian: Kombiniranje golimumaba in abatacepta ni priporočljivo.
English: Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use.
Slovenian: Vsak napolnjen injekcijski peresnik je namenjen za enkratno uporabo pri enem samem bolniku in ga je treba zavreči takoj po uporabi.
English: • Your doctor should test you for HBV
Slovenian: • Zdravnik vas mora testirati za HBV.
English: Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period.
Slovenian: Ker lahko izločanje golimumaba iz telesa traja do 5 mesecev, je treba v tem času bolnika še naprej spremljati.
English: • You should not take Simponi with medicines containing the active substance anakinra or abatacept.
Slovenian: • Zdravila Simponi ne smete jemati hkrati z zdravili, ki vsebujejo učinkovini anakinra ali abatacept.
English: Approximately forty-eight percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Slovenian: Približno 48 % bolnikov je še naprej jemalo stalne odmerke metotreksata (≤ 25 mg/teden).
English: Patients had at least 4 swollen and 4 tender joints.
Slovenian: Ti bolniki so imeli najmanj 4 otekle in 4 boleče sklepe.
English: ACR 70 Week 14 4% 14% p = 0.008
Slovenian: ACR 70 14. teden 4 % 14 % p = 0,008
English: • nervous system disease such as multiple sclerosis (rare).
Slovenian: • bolezni živčevja, kot je multipla skleroza (redko).
English: The higher incidence of antibodies with the drug-tolerant EIA method, because they were mainly low titre antibodies, did not have an apparent impact on drug levels, efficacy and safety and therefore does not represent any new safety signal.
Slovenian: Večja pojavnost protiteles pri metodi EIA, ki je tolerantna za zdravilo, zaradi večinoma nizkega titra protiteles ni imela opaznega vpliva na koncentracije zdravila, učinkovitost in varnost, zato ne predstavlja novega varnostnega signala.
English: If a small dose is set, the plunger will only move a short distance.
Slovenian: Če imate nastavljen majhen odmerek, se bo bat premaknil le malo.
English: Radiographic response:
Slovenian: Radiografski odziv
English: • The second ‘click' means that the injection is finished and the needle has gone back into the pre-filled pen.
Slovenian: • Drugi ‘klik' pomeni, da je injiciranje končano in se je igla vrnila nazaj v napolnjeni injekcijski peresnik.
English: In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Slovenian: Pri nekaterih bolnikih telo morda ne tvori dovolj krvnih celic, ki se borijo proti okužbam ali ustavijo krvavitve.
English: Wipe your chosen injection site with an alcohol swab and allow it to dry.
Slovenian: Izbrano mesto injiciranja obrišite z alkoholnim zložencem in pustite, da se posuši.
English: Additional analyses were performed in subsets representative of the indicated population of patients with severe, active and progressive RA.
Slovenian: Izvedene so bile tudi dodatne analize pri podskupinah, ki so reprezentativne za navedeno populacijo bolnikov s hudim, aktivnim in napredujočim revmatoidnim artritisom.
English: Therefore, a patient who maintained response was in a state of continuous clinical response at each evaluation through week 54.
Slovenian: Zato je bolnik, ki je ohranil odziv, imel kontinuirano klinični odgovor ob vsakem ocenjevanju do 54. tedna.
English: Patients in this study had a diagnosis of PsA for at least 6 months and had at least mild psoriatic disease.
Slovenian: Bolniki v tej študiji so imeli diagnozo psoriatičnega artritisa najmanj 6 mesecev in so imeli najmanj blago psoriatično bolezen.
English: Golimumab should not be given to patients with a clinically important, active infection.
Slovenian: Golimumaba se ne sme dajati bolnikom s klinično pomembno aktivno okužbo.