FrancophonIA/ELRC3.0 huggingface dataset:
English: Cyltezo is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Slovenian: Zdravilo Cyltezo je na voljo kot raztopina za injiciranje pod kožo v napolnjeni injekcijski brizgi ali peresniku in se običajno daje vsaka dva tedna.
English: After training, patients or their carers may inject Cyltezo if their doctor considers it appropriate.
Slovenian: Bolniki ali njihovi skrbniki lahko po opravljenem usposabljanju sami injicirajo zdravilo Cyltezo, če zdravnik meni, da je to zanje primerno.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Slovenian: Adalimumab z vezavo na TNF zavre njegovo delovanje ter tako zmanjša vnetja in druge simptome bolezni.
English: In addition, a study involving 645 patients with moderate or severe rheumatoid arthritis who were also taking methotrexate confirmed that Cyltezo and Humira have similar effectiveness.
Slovenian: Poleg tega je študija, ki je vključevala 645 bolnikov z zmernim ali hudim revmatoidnim artritisom, ki so jemali tudi metotreksat, potrdila, da je učinkovitost zdravil Cyltezo in Humira podobna.
English: For detailed information on the use of Cyltezo in all conditions, including when it can be used in children, see the summary of product characteristics.
Slovenian: Za podrobne informacije o uporabi zdravila Cyltezo pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte povzetek glavnih značilnosti zdravila.
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is calculated according to the child's weight and height.
Slovenian: Odmerek in pogostnost injiciranja sta odvisna od bolezni, ki se zdravi, pri otrocih pa se odmerek izračuna na podlagi njihove telesne mase in višine.
English: For more information about treatment with Cyltezo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cyltezo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Cyltezo?
Slovenian: Kakšna tveganja so povezana z zdravilom Cyltezo?
English: Cyltezo is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Slovenian: Zdravilo Cyltezo se večinoma uporablja pri odraslih, katerih bolezen je huda, zmerno huda ali se poslabšuje oziroma kadar bolnik ne more prejemati drugega zdravljenja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cyltezo have also been included in the summary of product characteristics and the
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cyltezo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za
English: What benefits of Cyltezo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cyltezo izkazalo v študijah?
English: Like other medicines of its class, Cyltezo may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Slovenian: Tako kot druga zdravila iz istega razreda tudi zdravilo Cyltezo lahko vpliva na obrambno sposobnost imunskega sistema proti okužbam in raku, saj so bili pri bolnikih, ki prejemajo adalimumab, zabeleženi nekateri primeri resnih okužb in krvnega raka.
English: The active substance in Cyltezo, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Slovenian: Zdravilna učinkovina v zdravilu Cyltezo, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanjo.
English: All these data were considered sufficient to conclude that Cyltezo will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Cyltezo pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Humira.
English: The company that markets Cyltezo must provide educational packs for doctors who prescribe the medicine.
Slovenian: Družba, ki trži zdravilo Cyltezo, mora pripraviti izobraževalno gradivo za zdravnike, ki zdravilo predpisujejo.
English: The reference medicine for Cyltezo is Humira.
Slovenian: Referenčno zdravilo za zdravilo Cyltezo je zdravilo Humira.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Slovenian: Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 1 000) vključujejo nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podobna obolenja (pri katerih imunski sistem napada bolnikova lastna tkiva, kar povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (hudo kožno obolenje).
English: Cyltezo is a medicine that acts on the immune system and is used to treat the following conditions:
Slovenian: Zdravilo Cyltezo učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Slovenian: Najpogostejši neželeni učinki adalimumaba (ki se pojavijo pri več kot 1 bolniku od 10) so okužbe (vključno z okužbami nosu, grla in sinusov), reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
English: This compared with 61% and 65% of those given Humira.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Humira, je bilo takšnih bolnikov 61 % oziroma 65 %.
English: Therefore, the Agency's view was that, as for Humira, the benefit outweighs the identified risk, and it recommended that Cyltezo be given marketing authorisation.
Slovenian: Agencija je tako menila, da enako kot pri zdravilu Humira koristi odtehtajo znana tveganja, in priporočila, da se za zdravilo Cyltezo izda dovoljenje za promet.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Cyltezo is used to treat.
Slovenian: TNF sodeluje pri povzročanju vnetij in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Cyltezo uporablja.
English: Because Cyltezo is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Cyltezo.
Slovenian: Zdravilo Cyltezo je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti adalimumaba, ki so že bile izvedene z zdravilom Humira, z zdravilom Cyltezo ni treba ponavljati.
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Slovenian: • aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno ankilozirajočega spondilitisa, in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases
Slovenian: • poliartikularnega juvenilnega idiopatskega artritisa in aktivnega artritisa, povezanega z entezitisom
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Cyltezo has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Cyltezo po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Humira in da se po telesu enako porazdeli.
English: It is not intended to provide practical advice on how to use Cyltezo.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Cyltezo must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the
Slovenian: Zdravilo Cyltezo se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati
English: Cyltezo contains the active substance adalimumab and is a ‘biosimilar medicine'.
Slovenian: Zdravilo Cyltezo vsebuje zdravilno učinkovino adalimumab in je „podobno biološko zdravilo“.
English: Treatment with Cyltezo must be started and supervised by a doctor who has experience in the treatment of the diseases for which Cyltezo is used.
Slovenian: Zdravljenje z zdravilom Cyltezo lahko uvede in nadzira le zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se zdravilo Cyltezo uporablja.
English: For the full list of side effects and restrictions with Cyltezo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cyltezo glejte navodilo za
English: In addition, a study in rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Slovenian: Poleg tega je študija revmatoidnega artritisa pokazala, da so učinki zdravila Cyltezo pri tej bolezni enakovredni učinkom zdravila Humira.
English: Doctors treating uveitis should also take advice from doctors who have experience of using Cyltezo.
Slovenian: Zdravniki, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Cyltezo.
English: For practical information about using Cyltezo, patients should read the package leaflet or contact their
Slovenian: Za praktične informacije o uporabi zdravila Cyltezo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
Slovenian: • obolenja hidradenitis suppurativa (inverznih aken), tj. dolgotrajnega obolenja kože, ki povzroča zatrdline, abscese (gnojne tvorbe) in kožne brazgotine;
English: Laboratory studies comparing Cyltezo with Humira have shown that the active substance in Cyltezo is highly similar to that in Humira in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Cyltezo primerjali z zdravilom Humira, so pokazale, da je zdravilna učinkovina zdravila Cyltezo po zgradbi, čistosti in biološkem delovanju zelo podobna zdravilni učinkovini v zdravilu Humira.
English: Studies have also shown that giving Cyltezo produces similar levels of the active substance in the body to giving Humira.
Slovenian: Študije so pokazale tudi, da zdravilo Cyltezo vzpostavi podobne ravni zdravilne učinkovine v telesu kot zdravilo Humira.
English: Comparable benefit continued to be seen with longer term
Slovenian: Primerljivo trajanje koristnega učinka zdravila so opazili tudi med 48-tedenskim dolgotrajnim zdravljenjem.
English: Cyltezo can only be obtained by prescription.
Slovenian: Predpisovanje in izdaja zdravila Cyltezo je le na recept.
English: An alert card will also be
Slovenian: Sočasno bodo bolniki prejeli
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Slovenian: • psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih zaplat na koži in vnetje
English: First 2 weeks:
Slovenian: Prva 2 tedna:
English: Date of first authorisation: 5 March 2014 Date of latest renewal: 11 January 2019
Slovenian: Datum prve odobritve: 5. marec 2014 Datum zadnjega podaljšanja: 11. januar 2019
English: Culture Conversion Status, n (%)
Slovenian: Status konverzije kulture, n (%)
English: Table 1: Culture conversion Status
Slovenian: Preglednica 1: status konverzije kulture
English: You may need to keep taking your other medicines for tuberculosis for longer than 6 months.
Slovenian: Morda boste morali druga zdravila proti tuberkulozi jemati več kot 6 mesecev.
English: The following definitions applies for resistance categories used:
Slovenian: Za kategorije odpornosti veljajo sledeče definicije:
English: The most common cause of death as reported by the investigator was tuberculosis (9 patients).
Slovenian: Najpogostejši vzrok smrti, ki so ga poročali raziskovalci, je bila tuberkuloza (9 bolnikov).
English: A final evaluation was conducted at Week 120.
Slovenian: Končno oceno so izvedli po koncu 120. tedna.
English: you may take SIRTURO on Monday, Wednesday and Friday every week from week 3
Slovenian: Zdravilo SIRTURO lahko jemljete na primer ob ponedeljkih, sredah in petkih vsak teden od 3. tedna dalje.
English: Take the medicine pack with you.
Slovenian: Škatlico z zdravilom vzemite s seboj.
English: The causes of death in the remaining patients varied.
Slovenian: Vzroki smrti pri ostalih bolnikih so bili različni.
English: • make your treatment ineffective and your tuberculosis could get worse, and;
Slovenian: • lahko postane zdravljenje neučinkovito, tuberkuloza pa se vam poslabša in
English: If this happens do not drive or operate machinery.
Slovenian: Če pride do tega, ne vozite in ne upravljajte strojev.
English: * Patients who died during the trial or discontinued the trial were considered as non-responders.
Slovenian: * Bolnike, ki so v času študije umrli ali pa so prekinili sodelovanje v študiji, so šteli kot neodzivne bolnike.
English: The clinical relevance is unknown.
Slovenian: Klinična pomembnost ni znana.
English: • increase the chance that the bacteria will become resistant to the medicine.
Slovenian: • povečujete možnost, da postanejo bakterije odporne na zdravilo.
English: The observed imbalance in deaths between the two treatment groups is unexplained.
Slovenian: Opaženo neravnovesje števila smrti med obema skupinama ni pojasnjeno.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Pri tem je treba upoštevati uradne smernice o primerni uporabi antibakterijskih učinkovin.
English: The food is important to get the right levels of medicine in your body.
Slovenian: Hrana je pomembna za doseganje prave koncentracije zdravila v telesu.
English: 188 tablets
Slovenian: 188 tablet
English: • you have liver disease or you drink alcohol on a regular basis;
Slovenian: • če imate bolezen jeter, ali če redno pijete alkohol
English: Data on longer treatment duration is very limited.
Slovenian: Podatkov o daljšem trajanju zdravljenja je zelo malo.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: The recommended dosage is:
Slovenian: Priporočeno odmerjanje:
English: • increased liver enzymes (shown in blood tests)
Slovenian: • zvišane koncentracije jetrnih encimov (kar pokaže krvna preiskava)
English: For additional information on deaths in the C209 trial, see section 5.1.
Slovenian: Za dodatne informacije o smrtnih primerih v študiji C209 glejte poglavje 5.1.
English: This medicine may pose a risk to the environment.
Slovenian: To zdravilo lahko predstavlja tveganje za okolje.
English: If you forget to take SIRTURO During the first 2 weeks
Slovenian: Če ste pozabili vzeti zdravilo SIRTURO V prvih 2 tednih
English: This means your disease may not be treatable by SIRTURO or other medicines in the future.
Slovenian: To pomeni, da vaše bolezni v prihodnje morda ne bo več mogoče zdraviti z zdravilom SIRTURO ali drugimi zdravili.
English: • you are allergic to bedaquiline or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na bedakilin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Main demographics were as follows: 63.1% were males, median age 34 years, 35% were Black, and 15% were HIV positive.
Slovenian: Glavni demografski podatki so bili naslednji: 63,1% je bilo moških, mediana starost 34 let, 35% je bilo črne rase in 15% je bilo HIV pozitivnih.
English: • Take the missed dose of 200 mg as soon as possible.
Slovenian: • Čim prej vzemite pozabljeni 200 mg odmerek.
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Kategorije pogostnosti so določene kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
English: Lactose intolerance and lactase deficiency
Slovenian: Intoleranca za laktozo in pomanjkanje laktaze
English: Antibiotics are medicines that kill bacteria that cause disease.
Slovenian: Antibiotiki so zdravila, ki delujejo tako, da ubijejo bakterije, ki povzročajo bolezni.
English: These reports should aid the physician in selecting a combination of antibacterial medicinal products for treatment.
Slovenian: Ta poročila naj bodo zdravniku v pomoč pri izbiranju kombinacije antibiotičnih zdravil za zdravljenje.
English: 24 tablets
Slovenian: 24 tablet
English: • Annual updates on study progress in the frame of annual renewal submissions
Slovenian: • Letne posodobitve napredka študije v okviru letnih vlog za podaljšanje dovoljenja za promet z zdravilom
English: S = susceptible R = resistant
Slovenian: S = občutljivi (angl. susceptible) organizmi R = odporni organizmi
English: Patients infected with human immunodeficiency virus (HIV)
Slovenian: Bolniki, okuženi z virusom humane imunske pomanjkljivosti (HIV)
English: • Clinically significant ventricular arrhythmia
Slovenian: • klinično pomembna ventrikularna aritmija
English: The safety and efficacy of SIRTURO in children aged < 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila SIRTURO pri otrocih, starih do 18 let, še nista bili dokazani.
English: Renal excretion of unchanged bedaquiline is insignificant (< 0.001%).
Slovenian: Izločanje nespremenjenega bedakilina skozi ledvice ni pomembno (< 0,001%).
English: This can be seen in a blood test;
Slovenian: To lahko pokaže krvni test.
English: Cavitation in one lung was seen in 58% of patients, and in both lungs in 16%.
Slovenian: 58% bolnikov je imelo kavitacijo v enem pljučnem krilu, 16% pa v obeh pljučnih krilih.
English: • Interim IDMC recommendation when half of the patients reach W76: 4Q2020
Slovenian: • Vmesna IDMC priporočila, ko polovica bolnikov doseže 76. teden: 4.četrtletje 2020
English: Patients should be advised to take SIRTURO exactly as prescribed and to complete the full course of therapy.
Slovenian: Bolnike je treba poučiti, da je treba zdravilo SIRTURO jemati natanko tako, kot je predpisano in da zaključijo celotno zdravljenje.
English: • Skip the missed dose and take the next dose as usual
Slovenian: • Izpustite pozabljeni odmerek in vzemite naslednji odmerek kot običajno.
English: This long terminal elimination phase likely reflects slow release of bedaquiline and M2 from peripheral tissues.
Slovenian: Tako dolga končna faza izločanja verjetno odraža počasno sproščanje bedakilina in presnovka M2 iz perifernih tkiv.
English: Environmental risk assessment studies have shown that bedaquiline has the potential to be persistent, bioaccumulative and toxic to the environment (see section 6.6).
Slovenian: Študije ocene tveganja za okolje so pokazale, da bi bedakilin lahko bil obstojen, bioakumulativen in strupen za okolje (glejte poglavje 6.6).
English: A plastic bottle containing 188 tablets.
Slovenian: Plastenka vsebuje 188 tablet.
English: Bedaquiline may have a minor influence on the ability to drive and use machines.
Slovenian: Bedakilin lahko blago vpliv na sposobnost vožnje in upravljanja s stroji.
English: • feeling or being sick (nausea or vomiting).
Slovenian: • občutek slabosti (navzea ali bruhanje).
English: The significance of phospholipidosis in humans is unknown.
Slovenian: Pomen fosfolipidoze pri ljudeh ni znan.
English: Bedaquiline prolongs the QTc interval.
Slovenian: Bedakilin podaljša interval QTc.
English: SIRTURO tablets should be swallowed whole with water.
Slovenian: Tablete SIRTURO je treba pogoltniti cele z vodo.
English: Any unused medicine should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
English: • aching or tender muscles, not caused by exercise
Slovenian: • bolečine ali občutljivost mišic, ki jih ne povzroči telesni napor
English: The intracellular bactericidal activity of bedaquiline in primary peritoneal macrophages and in a macrophage-like cell line was greater than its extracellular activity.
Slovenian: Znotrajcelična baktericidna aktivnost bedakilina v primarnih peritonealnih makrofagih in v liniji makrofagom podobnih celic je bila večja od njegove zunajcelične aktivnosti.
English: This study included patients of all three resistance categories (MDRH&R-, pre-XDR- and XDR-TB).
Slovenian: Študija je vključevala bolnike z vsemi tremi kategorijami odpornosti (MDRH&R, pre-XDR in XDR-TB).
English: If a dose is missed during the first two weeks of treatment, patients should not make up the missed dose, but should continue the usual dosing schedule.
Slovenian: Če bolnik izpusti odmerek v prvih dveh tednih zdravljenja, izpuščenega odmerka ne sme nadomeščati, ampak mora nadaljevati zdravljenje po običajnem razporedu.
English: Patients should be monitored throughout the treatment course, since the increases in liver enzymes were slow to appear and increased gradually during the 24 weeks.
Slovenian: Bolnike je treba spremljati med celotnim zdravljenjem, saj so se zvišanja koncentracij encimov so se pojavila pozno in koncentracije so se v obdobju 24 tednov postopno zviševale.
English: Clinical monitoring should be considered.
Slovenian: Razmisliti je treba o kliničnem spremljanju bolnika.
English: Maximum plasma concentrations (Cmax) are typically achieved at about 5 hours post-dose.
Slovenian: Normalno pride do najvišje koncentracije v plazmi (Cmax) približno 5 ur po odmerjanju.
English: Each tablet contains 145 mg of lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 145 mg laktoze (v obliki laktoze monohidrata).
English: • you have human immunodeficiency virus (HIV) infection.
Slovenian: • če ste okuženi z virusom humane imunske pomanjkljivosti (HIV).
English: Response rates at week 24 and week 120 (i.e. around 6 months after stopping all therapy) are presented in table 1.
Slovenian: Stopnja odgovora v 24. tednu in 120. tednu (približno 6 mesecev po prekinitvi vsega zdravljenja) je navedena v preglednici 1.