FrancophonIA/ELRC3.0 huggingface dataset:
English: Tacforius is used for the long-term treatment of adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Slovenian: Zdravilo Tacforius se uporablja pri dolgotrajnem zdravljenju odraslih bolnikov s presajenimi ledvicami ali jetri za preprečevanje zavrnitve organa (pri kateri imunski sistem napade presajeni organ).
English: Therefore, the Agency's view was that, as for Advagraf, the benefit outweighs the identified risk.
Slovenian: Zato je menila, da njegove koristi enako kot pri zdravilu Advagraf odtehtajo znana tveganja.
English: Why is Tacforius approved?
Slovenian: Zakaj je bilo zdravilo Tacforius odobreno?
English: Tacforius can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Tacforius je le na recept.
English: Tacrolimus, the active substance in Tacforius, is an immunosuppressive medicine.
Slovenian: Zdravilna učinkovina v zdravilu Tacforius, takrolimus, je zdravilo za zaviranje imunske odzivnosti.
English: How has Tacforius been studied?
Slovenian: Kako je bilo zdravilo Tacforius raziskano?
English: How does Tacforius work?
Slovenian: Kako zdravilo Tacforius deluje?
English: How is Tacforius used?
Slovenian: Kako se zdravilo Tacforius uporablja?
English: This is a life-long treatment.
Slovenian: Zdravljenje je vseživljenjsko.
English: Further information on Ultomiris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ultomiris.
Slovenian: Nadaljnje informacije za zdravilo Ultomiris so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Ultomiris.
English: Patients should take antibiotics for 2 weeks after they have been vaccinated.
Slovenian: Bolniki morajo antibiotike jemati še dva tedna po cepljenju.
English: The Agency therefore decided that Ultomiris' benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Ultomiris večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: It must also not be used in patients who have not been vaccinated against this infection unless they are taking antibiotics to reduce the risk of infection.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki niso bili cepljeni proti tej okužbi, razen če jemljejo antibiotike za zmanjšanje tveganja okužbe.
English: The European Medicines Agency also noted that Ultomiris has a more convenient treatment schedule (with one infusion every 8 weeks instead of every 2 weeks).
Slovenian: Evropska agencija za zdravila je tudi ugotovila, da ima zdravilo Ultomiris bolj primerno shemo zdravljenja (ena infuzija vsakih osem tednov namesto vsaka dva tedna).
English: The change in blood levels of LDH after 6 months of treatment was similar in the 2 groups.
Slovenian: Sprememba ravni LDH v krvi po šestih mesecih zdravljenja je bila podobna v obeh skupinah.
English: What measures are being taken to ensure the safe and effective use of Ultomiris?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ultomiris?
English: In addition, around half of the patients in both groups had achieved normal blood levels of the enzyme LDH.
Slovenian: Poleg tega so bile pri približno polovici bolnikov v obeh skupinah dosežene normalne ravni encima LDH v krvi.
English: As for all medicines, data on the use of Ultomiris are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ultomiris stalno spremljajo.
English: Patients receive an initial dose (called loading dose) and then a maintenance dose once every 8 weeks, starting 2 weeks after the loading dose.
Slovenian: Bolniki prejmejo začetni odmerek (imenovan udarni ali polnilni odmerek) in nato vzdrževalni odmerek enkrat na osem tednov, s čimer se začne dva tedna po udarnem odmerku.
English: After 6 months of treatment, similar benefits were seen in both groups, with two-thirds or more of patients (74% given Ultomiris and 66% given eculizumab) not needing red blood cell transfusions.
Slovenian: Po šestih mesecih zdravljenja so bile v obeh skupinah opažene podobne koristi, saj dve tretjini ali več bolnikov (74 %, ki so jemali zdravilo Ultomiris in 66 %, ki so prejemali ekulizumab), ni potrebovalo transfuzije rdečih krvnih celic.
English: It should be used after patients have been treated with eculizumab (another medicine for PNH) for at least the past 6 months.
Slovenian: Uporabiti bi ga bilo treba po tem, ko je bolnik prejemal ekulizumab (drugo zdravilo za PNH) vsaj zadnjih šest mesecev.
English: Other information about Ultomiris
Slovenian: Druge informacije o zdravilu Ultomiris
English: Why is Ultomiris authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Ultomiris odobreno v EU?
English: What benefits of Ultomiris have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ultomiris izkazalo v študijah?
English: By attaching to the C5 protein, the medicine blocks its effect and thereby reduces the destruction of red blood cells.
Slovenian: Z vezavo na beljakovino C5 zdravilo zavre njen učinek in s tem zmanjša uničenje rdečih krvnih celic.
English: Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH).
Slovenian: Ultomiris je zdravilo, ki se uporablja za zdravljenje odraslih s paroksizmalno nočno hemoglobinurijo (PNH).
English: The most serious side effect is meningococcal infection, a bacterial infection caused by Neisseria meningitidis that can cause meningitis and blood poisoning.
Slovenian: Najresnejši neželeni učinek je okužba z meningokoki, bakterijska okužba, ki jo povzroča bakterija Neisseria meningitidis, ki lahko povzroči meningitis in zastrupitev krvi.
English: The most common side effects with Ultomiris (which may affect more than 1 in 10 people) are upper respiratory tract infection (nose and throat infection), nasopharyngitis (inflammation of the nose and throat) and headache.
Slovenian: Najpogostejši neželeni učinki zdravila Ultomiris (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužba zgornjih dihal (okužba nosu in grla), nazofaringitis (vnetje nosu in žrela) in glavobol.
English: An overview of Ultomiris and why it is authorised in the EU
Slovenian: Pregled zdravila Ultomiris in zakaj je odobreno v EU
English: For more information about using Ultomiris, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ultomiris glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Ultomiris are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ultomiris, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Because patients treated with Ultomiris are more prone to infections, including severe meningococcal disease, Ultomiris must not be used in patients who have an ongoing meningococcal infection.
Slovenian: Ker so bolniki, zdravljeni z zdravilom Ultomiris, bolj nagnjeni k okužbam, vključno s hudo meningokokno boleznijo, se zdravilo Ultomiris ne sme uporabljati pri bolnikih, ki imajo meningokokno okužbo.
English: In PNH, proteins known as the 'complement system', which is part of the immune system, become overactive because of a genetic mutation and start to attack the patients' own red blood cells.
Slovenian: Pri PNH beljakovine, imenovane „sistem komplementa“, ki je del imunskega sistema, zaradi genske mutacije postanejo preveč aktivne in začnejo napadati bolnikove lastne rdeče krvne celice.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ultomiris have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ultomiris upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What are the risks associated with Ultomiris?
Slovenian: Kakšna tveganja so povezana z zdravilom Ultomiris?
English: What is Ultomiris and what is it used for?
Slovenian: Kaj je zdravilo Ultomiris in za kaj se uporablja?
English: The company that markets Ultomiris will ensure that the medicine is only made available to patients when healthcare professionals have made a written declaration that they have been vaccinated or are receiving antibiotic treatment to prevent meningococcal disease.
Slovenian: Podjetje, ki trži zdravilo Ultomiris, bo zagotovilo, da je zdravilo bolnikom na voljo le, če zdravstveni delavci pisno izjavijo, da so bili cepljeni ali prejemajo zdravljenje z antibiotiki za preprečevanje meningokokne bolezni.
English: As for its safety, Ultomiris has similar side effects to eculizumab.
Slovenian: Kar zadeva varnost, ima zdravilo Ultomiris podobne neželene učinke kot ekulizumab.
English: Patients will also be given a special card that explains the symptoms of meningococcal infection, instructing patients to seek medical care immediately if they experience them.
Slovenian: Bolniki bodo prejeli tudi posebno kartico, v kateri so pojasnjeni simptomi meningokokne okužbe, in navodila, da takoj poiščejo zdravniško pomoč, če se pojavijo.
English: PNH is a potentially life-threatening disease in which there is excessive breakdown of red blood cells, leading to problems such as anaemia (low red blood cell counts), kidney problems and blood clots in the blood vessels.
Slovenian: PNH je potencialno življenjsko nevarna bolezen, pri kateri prihaja do čezmerne razgradnje rdečih krvnih celic, kar povzroča težave, kot so anemija (nizko število rdečih krvnih celic), težave z ledvicami in krvni strdki v krvnih žilah.
English: The company will also provide prescribers and patients with information on the safety of the medicine, and will send reminders to prescribers and pharmacists to check if re-vaccination is needed for patients taking Ultomiris.
Slovenian: Zdravnikom, ki predpisujejo zdravilo, in bolnikom bo podjetje priskrbelo tudi informacije o varnosti zdravila ter poslala opomnike zdravnikom, ki predpisujejo zdravilo, in farmacevtom, da preverijo, ali je za bolnike, ki prejemajo zdravilo Ultomiris, potrebno kakršno koli ponovno cepljenje.
English: Ultomiris is used in patients who have symptoms of the disease as well as in patients who have stable blood levels of the enzyme lactate dehydrogenase (LDH), which gives an indication of how many red blood cells are being broken down.
Slovenian: Zdravilo Ultomiris se uporablja pri bolnikih, ki imajo simptome bolezni, in pri bolnikih, ki imajo stabilne ravni encima laktat dehidrogenaze (LDH) v krvi, kar kaže, koliko rdečih krvnih celic je razgrajenih.
English: The active substance contained in Ultomiris, ravulizumab, is a monoclonal antibody (a type of protein) designed to attach to the C5 protein, which is part of the complement system.
Slovenian: Učinkovina zdravila Ultomiris, ravulizumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se veže na beljakovino C5, ki je del sistema komplementa.
English: Ultomiris is given as an infusion (drip) into a vein and the recommended dose depends on the patient's bodyweight.
Slovenian: Zdravilo Ultomiris se daje z infundiranjem (kapalno infuzijo) v veno, priporočeni odmerek pa je odvisen od telesne mase bolnika.
English: The medicine can only be obtained with a prescription and must be given under the supervision of a doctor who has experience in the management of patients with blood disorders.
Slovenian: Predpisovanje in izdaja zdravila Ultomiris je le na recept, dajati pa ga je treba pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem krvnih bolezni.
English: In the second study in 195 patients with PNH who did not have symptoms after at least 6 months of treatment with eculizumab, patients either continued treatment with eculizumab or switched to Ultomiris.
Slovenian: V drugi študiji s 195 bolniki s paroksizmalno nočno hemoglobinurijo, ki niso imeli simptomov po najmanj šestmesečnem zdravljenju z ekulizumabom, so ti zdravljenje bodisi nadaljevali z ekulizumabom ali pa so prešli na zdravilo Ultomiris.
English: In addition, none of the patients treated with Ultomiris had a flare-up of symptoms during this time, in comparison to 5 of those continuing with eculizumab.
Slovenian: Poleg tega pri nobenem od bolnikov, ki so bili zdravljeni z zdravilom Ultomiris, v tem času simptomi niso ponovno izbruhnili, medtem ko se je to zgodilo pri petih bolikih, ki so nadaljevali z jemanjem ekulizumaba.
English: For the full list of side effects and restrictions with Ultomiris, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ultomiris glejte navodilo za uporabo.
English: In the first study, 246 patients with PNH who previously had not been treated with a medicine blocking the complement system, such as eculizumab, received either Ultomiris or eculizumab.
Slovenian: V prvi študiji je 246 bolnikov s paroksizmalno nočno hemoglobinurijo, ki prej niso bili zdravljeni z zdravilom, ki zavira sistem komplementa, kot je ekulizumab, prejemalo zdravilo Ultomiris ali ekulizumab.
English: Ultomiris is as effective as eculizumab in treating patients with PNH, reducing the breakdown of red blood cells and avoiding the need for transfusions.
Slovenian: Zdravilo Ultomiris je enako učinkovito kot ekulizumab pri zdravljenju bolnikov s PNH, saj zmanjšuje razgradnjo rdečih krvnih celic in preprečuje potrebo po transfuzijah.
English: Ultomiris was shown in 2 studies to be as effective as eculizumab in reducing the breakdown of red blood cells and avoiding the need for transfusions in patients with PNH.
Slovenian: Zdravilo Ultomiris se je v dveh študijah izkazalo enako učinkovito kot ekulizumab pri zmanjševanju razgradnje rdečih krvnih celic in izogibanju potrebi po transfuzijah pri bolnikih s paroksizmalno nočno hemoglobinurijo.
English: How is Ultomiris used?
Slovenian: Kako se zdravilo Ultomiris uporablja?
English: How does Ultomiris work?
Slovenian: Kako zdravilo Ultomiris deluje?
English: Ultomiris contains the active substance ravulizumab.
Slovenian: Zdravilo Ultomiris vsebuje učinkovino ravulizumab.
English: Adults and elderly (> 65 years)
Slovenian: Odrasli in starejši (> 65 let)
English: Please tell your doctor immediately:
Slovenian: Nemudoma obvestite zdravnika:
English: Other pharmaceutical forms may be available for this population.
Slovenian: Za to populacijo so morda na voljo druge farmacevtske oblike.
English: The volume of distribution is high (approximately 1,000 litres), indicating extensive distribution.
Slovenian: Volumen porazdelitve je velik (približno 1000 litrov), kar kaže na obširno porazdelitev.
English: The risk of having seizures is higher if you have had them before;
Slovenian: Tveganje za pojav napadov krčev je večje, če ste jih imeli že kdaj prej;
English: Date of first authorisation: 19 November 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 19 november 2015
English: Reference should be made to current treatment guidelines.
Slovenian: Upoštevati je treba veljavne smernice za zdravljenje.
English: Tell your doctor if you are taking the following medicines.
Slovenian: Zdravniku morate povedati, če jemljete naslednja zdravila.
English: For additional information see section 4.
Slovenian: Za dodatne informacije glejte poglavje 4.
English: No change in starting dose is necessary.
Slovenian: Začetnega odmerka ni treba spremeniti.
English: A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics.
Slovenian: Izvedli so populacijsko farmakokinetično analizo za oceno vplivov demografskih značilnosti.
English: The normal calcium range may differ depending on the methods used by your local laboratory.
Slovenian: Razpon normalne koncentracije kalcija se lahko razlikuje glede na metodo, ki jo uporablja vaš lokalni laboratorij.
English: Clearance of cinacalcet may be lower in women than in men.
Slovenian: Očistek cinakalceta je pri ženskah morda manjši kot pri moških.
English: Hypocalcaemia (see sections 4.2 and 4.4).
Slovenian: Hipokalciemija (glejte poglavji 4.2 in 4.4).
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, parturition or postnatal development.
Slovenian: Študije na živalih niso pokazale neposrednih škodljivih vplivov na nosečnost, porod ali postnatalni razvoj.
English: Cinacalcet did not show any genotoxic or carcinogenic potential.
Slovenian: Cinakalcet ni pokazal genotoksičnega ali kancerogenega potenciala.
English: Your doctor will take regular blood samples during treatment to monitor your progress and will adjust your dose if necessary.
Slovenian: Zdravnik vam bo med zdravljenjem redno jemal kri, da bo nadziral potek, in če bo potrebno, vam bo prilagodil odmerek.
English: Other possible side effects:
Slovenian: Ostali možni neželeni učinki:
English: Increases in plasma cinacalcet concentration are similar, regardless of the fat content of the meal.
Slovenian: Zvišanje koncentracije cinakalceta v plazmi je podobno, ne glede na vsebnost maščob v obroku.
English: 66% of patients were receiving vitamin D sterols at study entry, and > 90% were receiving phosphate binders.
Slovenian: 66 % bolnikov je ob vključitvi v študijo dobivalo sterole vitamina D, > 90 % pa jih je dobivalo vezalce fosfatov.
English: You should inform your doctor if you experience any of the signs of low calcium levels as described above.
Slovenian: Zdravnika morate obvestiti, če se vam pojavi kateri koli znak nizke koncentracije kalcija, kot je opisano zgoraj.
English: The clinical significance of these reductions in serum testosterone is unknown.
Slovenian: Klinični pomen teh znižanj testosterona v serumu ni znan.
English: At doses above 200 mg, the absorption was saturated probably due to poor solubility.
Slovenian: V odmerkih nad 200 mg se absorpcija zasiti, verjetno zaradi slabe topnosti.
English: Treatment should be reinitiated using the next lowest dose of cinacalcet.
Slovenian: Zdravljenje je treba ponovno začeti z naslednjim najnižjim odmerkom cinakalceta.
English: Very common: may affect more than 1 in 10 people • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Slovenian: Zelo pogosti: pojavijo se lahko pri najmanj 1 od 10 bolnikov • navzea in bruhanje; ta neželena učinka sta ponavadi blaga in ne trajata dolgo.
English: Approximately 80% of the dose was recovered in the urine and 15% in the faeces.
Slovenian: Približno 80 % odmerka se je pojavilo v urinu in 15 % v blatu.
English: In the event of overdose, patients should be monitored for signs and symptoms of hypocalcaemia, and treatment should be symptomatic and supportive.
Slovenian: V primeru prevelikega odmerka je treba bolnike spremljati glede znakov in simptomov hipokalciemije, zdravljenje pa mora biti simptomatsko in podporno.
English: Reductions in iPTH and Ca x P were maintained for up to 12 months of treatment.
Slovenian: Znižanje iPTH in Ca x P se je ohranilo do 12 mesecev zdravljenja.
English: The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.
Slovenian: Pogostnosti posameznih prednostnih izrazov, vključno z angioedemom in urtikarijo, iz razpoložljivih podatkov ni mogoče oceniti.
English: The clinical relevance is unknown, however, the potential for cinacalcet to act on these secondary targets cannot be fully excluded.
Slovenian: Klinični pomen tega ni znan, ni pa mogoče povsem izključiti možnosti delovanja cinakalceta na te sekundarne cilje.
English: Reduce or withhold dose of cinacalcet.
Slovenian: Zmanjšajte ali zadržite odmerek cinakalceta.
English: Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
Slovenian: Kajenje inducira CYP1A2; očistek cinakalceta pri kadilcih je za 36 - 38 % večji kot pri nekadilcih.
English: Do not take Cinacalcet Mylan if you are allergic to cinacalcet or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Cinakalcet Mylan, če ste alergični na cinakalcet ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: If you experience these side effects do not drive or operate machines.
Slovenian: Če se vam pojavijo ti neželeni učinki, ne upravljajte vozil in strojev.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, še zlasti pa etelkalcetid ali kakšna druga zdravila, ki znižujejo koncentracijo kalcija v krvi.
English: It is used to treat problems with organs called parathyroid glands.
Slovenian: Uporabljamo ga za zdravljenje težav z organi, ki jih imenujemo obščitnične žleze.
English: The maximum dose used in clinical trials was 90 mg four times daily.
Slovenian: Največji odmerek, uporabljen v kliničnih preskušanjih, je bil 90 mg štirikrat na dan.
English: Cinacalcet Mylan should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo Cinakalcet Mylan naj bi med nosečnostjo uporabljati le, če možne koristi odtehtajo potencialno tveganje za plod.
English: Reduction of hypercalcaemia in patients with:
Slovenian: Zmanjšanje hiperkalciemije pri bolnikih s:
English: The safety and efficacy of cinacalcet in the paediatric population have not been established.
Slovenian: Varnost in učinkovitost cinakalceta v pediatrični populaciji nista ugotovljeni.
English: Low calcium levels can have an effect on your heart rhythm.
Slovenian: Nizke koncentracije kalcija lahko vplivajo na vaš srčni ritem.
English: • loss (anorexia) or decrease of appetite
Slovenian: • izguba apetita (anoreksija) ali zmanjšanje apetita,
English: Steady state levels of cinacalcet are achieved within 7 days with minimal accumulation.
Slovenian: Stanje dinamičnega ravnovesja cinakalceta je doseženo v 7 dneh ob minimalnem kopičenju.
English: * see section c) see section 4.4
Slovenian: * glejte podpoglavje c) † glejte poglavje 4.4
English: This analysis showed no significant impact of age, sex, race, body surface area, and body weight on cinacalcet pharmacokinetics.
Slovenian: Ta analiza ni pokazala pomembnega vpliva starosti, spola, telesne površine in telesne mase na farmakokinetiko cinakalceta.
English: Hypotension and/or worsening heart failure
Slovenian: Hipotenzija in/ali poslabšanje srčnega popuščanja
English: 4.8 Undesirable effects a)
Slovenian: 4.8 Neželeni učinki a) Povzetek varnostnega profila
English: Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki, ki jih je na podlagi ocene najboljših dokazov o vzročnosti vsaj možno pripisati zdravljenju s cinakalcetom iz študij, nadzorovanih s placebom, in študij z enim krakom, so navedeni spodaj ob upoštevanju sledečega dogovora: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10), občasni; (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Incidence of adverse reactions from controlled clinical studies and post-marketing experience are:
Slovenian: Pogostnosti neželenih učinkov iz nadzorovanih kliničnih študij in iz obdobja trženja zdravila so: