FrancophonIA/ELRC3.0 huggingface dataset:
English: Lusduna is a ‘biosimilar medicine'.
Slovenian: Zdravilo Lusduna je „podobno biološko zdravilo“.
English: Lusduna insulin glargine
Slovenian: Lusduna insulin glargin
English: Why is Lusduna approved?
Slovenian: Zakaj je bilo zdravilo Lusduna odobreno?
English: Lusduna is available in pre-filled disposable pens and can only be obtained with a prescription.
Slovenian: Zdravilo Lusduna je na voljo v napolnjenih injekcijskih peresnikih za enkratno uporabo ter se predpisuje in izdaja le na recept.
English: Two supportive studies found that the effectiveness of once-daily Lusduna was comparable to Lantus.
Slovenian: V dveh podpornih študijah so ugotovili, da je učinkovitost zdravila Lusduna z enkrat dnevnim odmerjanjem primerljiva z učinkovitostjo zdravila Lantus.
English: It is not intended to provide practical advice on how to use Lusduna.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Extensive laboratory studies comparing Lusduna with Lantus have shown that insulin glargine in Lusduna is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Slovenian: Obsežne laboratorijske študije, v katerih so zdravilo Lusduna primerjali z zdravilom Lantus, so pokazale, da je zdravilna učinkovina insulin glargin zdravila Lusduna po zgradbi, čistosti in biološkem delovanju zelo podobna zdravilni učinkovini zdravila Lantus.
English: How does Lusduna work?
Slovenian: Kako zdravilo Lusduna deluje?
English: How is Lusduna used?
Slovenian: Kako se zdravilo Lusduna uporablja?
English: Lusduna can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 se zdravilo Lusduna lahko uporablja tudi s peroralnimi zdravili za zdravljenje sladkorne bolezni.
English: Further information on Talzenna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/talzenna
Slovenian: Nadaljnje informacije o zdravilu Talzenna so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/talzenna
English: What measures are being taken to ensure the safe and effective use of Talzenna?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Talzenna?
English: The European Medicines Agency therefore decided that Talzenna's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Talzenna večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Women must not breastfeed during treatment with Talzenna and for a month after stopping treatment.
Slovenian: Ženske med zdravljenjem z zdravilom Talzenna in še en mesec po koncu zdravljenja ne smejo dojiti.
English: Talzenna can increase the time these patients live without their disease getting worse.
Slovenian: Zdravilo Talzenna lahko podaljša čas preživetja teh bolnikov brez poslabšanja bolezni.
English: As for all medicines, data on the use of Talzenna are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Talzenna stalno spremljajo.
English: Other information about Talzenna
Slovenian: Druge informacije o zdravilu Talzenna
English: What benefits of Talzenna have been shown in studies?
Slovenian: Kakšne koristi zdravila Talzenna so se pokazale v študijah?
English: The dose may be reduced or treatment interrupted if certain side effects develop.
Slovenian: Odmerek bo morda treba zmanjšati ali zdravljenje prekiniti, če se pojavijo določeni neželeni učinki.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talzenna have 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 Talzenna upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What is Talzenna and what is it used for?
Slovenian: Kaj je zdravilo Talzenna in za kaj se uporablja?
English: An overview of Talzenna and why it is authorised in the EU
Slovenian: Pregled zdravila Talzenna in zakaj je odobreno v EU
English: Why is Talzenna authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Talzenna odobreno v EU?
English: What are the risks associated with Talzenna?
Slovenian: Kakšna tveganja so povezana z zdravilom Talzenna?
English: For more information about using Talzenna, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Talzenna glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and as a result the cancer cells die.
Slovenian: Z zaviranjem beljakovin PARP se poškodovana DNK v rakavih celicah ne more popraviti, zato rakave celice odmrejo.
English: Side effects reported with Talzenna are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Talzenna, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The side effects with Talzenna were generally well-tolerated and when needed, manageable with dose modifications, and/or standard supportive medical therapy.
Slovenian: Neželene učinke zdravila Talzenna so bolniki na splošno dobro prenašali, po potrebi pa so bili obvladljivi s spremembami odmerka in/ali standardnimi podpornimi medicinskimi terapijami.
English: The active substance in Talzenna, talazoparib, blocks the action of enzymes called human poly-ADP ribose polymerase (PARP), which are proteins that help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Slovenian: Učinkovina v zdravilu Talzenna, talazoparib, zavira delovanje encimov, imenovanih humane poli (ADPriboza) polimeraze (PARP), tj. beljakovin, ki v celicah (normalnih in rakavih) med celično delitvijo pomagajo popravljati poškodovano DNK.
English: Talzenna can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Talzenna je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: Talzenna is a cancer medicine used on its own to treat a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site, in patients who have been treated with certain medicines which have stopped working or when these medicines are not suitable.
Slovenian: Talzenna je zdravilo za zdravljenje raka, ki se samostojno uporablja za zdravljenje vrste raka dojke (HER2-negativnega raka dojke z mutacijami BRCA), ki se je razširil zunaj prvotnega mesta, pri bolnikih, ki so bili zdravljeni z določenimi zdravili, ki so prenehala delovati, ali kadar ta zdravila niso primerna.
English: The most common severe side effects (which may affect more than 1 in 10 people) which led to changes in the dose of Talzenna are anaemia, neutropenia and thrombocytopenia.
Slovenian: Najpogostejši resni neželeni učinki (ki se lahko pojavijo pri več kot 1 osebi od 10), zaradi katerih je bilo treba spremeniti odmerke zdravila Talzenna, so anemija, nevtropenija in trombocitopenija.
English: Talzenna was shown to be effective at increasing the time patients live without their disease getting worse in one main study involving 431 patients with HER2-negative breast cancer with BRCA mutations whose cancer had spread.
Slovenian: Zdravilo Talzenna se je izkazalo za učinkovito pri podaljšanju časa, ki ga bolniki preživijo brez poslabšanja bolezni, v eni glavni študiji, v katero je bilo vključenih 431 bolnikov s HER2-negativnim rakom dojke z mutacijami BRCA, pri katerih se je rak razširil.
English: The most common side effects with Talzenna (which may affect more than 1 in 4 people) are tiredness, anaemia (low red blood cell counts which can cause tiredness and pale skin), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), thrombocytopenia (low blood levels of platelets), and headache.
Slovenian: Najpogostejši neželeni učinki zdravila Talzenna (ki se lahko pojavijo pri več kot 1 osebi od 4) so utrujenost, anemija (nizko število rdečih krvnih celic, ki lahko povzroči utrujenost in bledo kožo), navzeja (siljenje na bruhanje), nevtropenija (nizke ravni nevtrofilcev, tj. vrste belih krvnih celic, ki se borijo proti okužbam), trombocitopenija (nizka raven trombocitov) in glavobol.
English: Talzenna is available as capsules (1 mg and 0.25 mg) and the recommended dose is 1 mg once a day.
Slovenian: Zdravilo Talzenna je na voljo v obliki kapsul (1 mg in 0,25 mg), priporočeni odmerek pa je 1 mg enkrat na dan. Zdravljenje je treba nadaljevati, dokler ima bolnik od njega korist, neželeni učinki pa so znosni.
English: Patients treated with Talzenna lived on average for 8.6 months without their disease getting worse compared with 5.6 months for patients treated with the doctor's choice of another cancer medicine.
Slovenian: so v povprečju živeli 8,6 meseca brez poslabšanja bolezni, bolniki, ki so prejemali drugo zdravilo za zdravljenje raka po zdravnikovi presoji, pa 5,6 meseca.
English: Talzenna contains the active substance talazoparib.
Slovenian: Zdravilo Talzenna vsebuje učinkovino talazoparib.
English: Generally the outcome is poor for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread.
Slovenian: Na splošno je za bolnike s HER2-negativnim rakom dojke z mutacijami BRCA, pri katerih rak se je razširil, izid slab.
English: For the full list of side effects and restrictions with Talzenna, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Talzenna glejte navodilo za uporabo.
English: How is Talzenna used?
Slovenian: Kako se zdravilo Talzenna uporablja?
English: How does Talzenna work?
Slovenian: Kako zdravilo Talzenna deluje?
English: Further information on Fasenra can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/fasenra.
Slovenian: Nadaljnje informacije za zdravilo Fasenra so na voljo na spletni strani agencije: ema.europa.eu/medicines/Human/EPAR/fasenra.
English: Fasenra received a marketing authorisation valid throughout the EU on 8 January 2018.
Slovenian: Za zdravilo Fasenra je bilo 8. januarja 2018 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Fasenra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fasenra?
English: The European Medicines Agency therefore decided that Fasenra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Fasenra večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: The recommended dose is 30 mg injected under the skin of the thighs or belly every 4 weeks for the first 3 doses, and every 8 weeks afterwards.
Slovenian: Priporočeni odmerek je 30 mg, injiciran v podkožje stegna ali trebuha vsake štiri tedne pri prvih treh odmerkih, nato pa vsakih osem tednov.
English: Fasenra should be given for as long as the patient benefits from it, and doctors should re-assess at least once a year whether treatment should be continued.
Slovenian: Zdravilo Fasenra je treba dajati, dokler bolniku koristi, zdravnik pa naj o nadaljevanju zdravljenja presodi vsaj enkrat letno.
English: As for all medicines, data on the use of Fasenra are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Fasenra stalno spremljajo.
English: Side effects reported with Fasenra are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Fasenra, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Fasenra have been shown in studies?
Slovenian: Kakšne koristi zdravila Fasenra so se pokazale v študijah?
English: This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.
Slovenian: S tem ublaži vnetje, kar zmanjša število napadov astme in izboljša simptome.
English: The medicine is well tolerated with few side effects.
Slovenian: Bolniki zdravilo dobro prenašajo in imajo malo neželenih učinkov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fasenra have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fasenra upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Why is Fasenra authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Fasenra odobreno v EU?
English: An overview of Fasenra and why it is authorised in the EU
Slovenian: Pregled zdravila Fasenra in zakaj je odobreno v EU
English: For more information about using Fasenra, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Fasenra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Fasenra
Slovenian: Druge informacije o zdravilu Fasenra
English: What are the risks associated with Fasenra?
Slovenian: Kakšna tveganja so povezana z zdravilom Fasenra?
English: What is Fasenra and what is it used for?
Slovenian: Kaj je zdravilo Fasenra in za kaj se uporablja?
English: If the injection is given by a doctor or carer, it can also be given under the skin of the upper arm.
Slovenian: Če zdravilo injicira zdravnik ali negovalec, se lahko injekcija daje tudi v podkožje nadlakti.
English: A third study involving 220 patients showed that more patients given Fasenra had their condition improved to the extent that they could reduce their dose of corticosteroids by an average of 75% compared with 25% of those given placebo.
Slovenian: Tretja študija, v katero je bilo vključenih 220 bolnikov, je pokazala, da je bil delež bolnikov, pri katerih se je stanje izboljšalo toliko, da so lahko zmanjšali odmerek kortikosteroidov, večji pri bolnikih, ki so prejemali zdravilo Fasenra, kot pri tistih, ki so prejemali placebo, in sicer 75 % v primerjavi s 25 %.
English: Among patients with the highest number of blood eosinophils before treatment, the number of severe flareups per year was 0.66 in patients treated with Fasenra (given every 4 weeks for the first 3 doses and every 8 weeks afterwards), compared with 1.14 in patients given placebo (a dummy treatment).
Slovenian: Pri bolnikih z najvišjo koncentracijo eozinofilcev v krvi pred zdravljenjem je bilo število hudih zagonov bolezni na leto v skupini bolnikov, zdravljenih z zdravilom Fasenra (pri čemer so prve tri odmerke prejeli v razmiku štirih tednov, naslednje odmerke pa vsakih osem tednov), 0,66, pri bolnikih, ki so prejemali placebo (zdravilo brez učinkovine), pa 1,14.
English: The most common side effects with Fasenra (which may affect up to 1 in 10 people) include headache and pharyngitis (sore throat).
Slovenian: Najpogostejša neželena učinka zdravila Fasenra (ki se lahko pojavita pri največ 1 bolniku od 10) sta glavobol in faringitis (vnetje žrela).
English: If agreed with the treating doctor, patients already using Fasenra and with no history of severe allergic reactions, or their carers, can inject Fasenra themselves after proper training, including on how to watch out for signs and symptoms of allergic reactions.
Slovenian: Z dovoljenjem lečečega zdravnika lahko bolniki, ki že uporabljajo zdravilo Fasenra in niso nikoli imeli resnih alergijskih reakcij, ali njihovi negovalci po opravljenem ustreznem usposabljanju, ki je vključevalo tudi napotke za spremljanje znakov in simptomov alergijskih reakcij, sami injicirajo zdravilo Fasenra.
English: It can only be obtained with a prescription and treatment should be started by doctors with experience in the diagnosis and treatment of severe asthma.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem hude astme.
English: It is used as an additional treatment in adults with severe asthma that is not adequately controlled by a combination of high-dose inhaled corticosteroids plus medicines called long-acting beta-agonists.
Slovenian: Uporablja se kot dodatno zdravljenje pri odraslih s hudo astmo, ki ni ustrezno urejena s kombinacijo velikih odmerkov inhalacijskih kortikosteroidov in zdravil, imenovanih dolgodelujoči agonisti beta.
English: The active substance in Fasenra, benralizumab, is a monoclonal antibody (a type of protein) designed to attach to receptors (targets) called interleukin-5 receptors on the surface of eosinophils.
Slovenian: Učinkovina v zdravilu Fasenra, benralizumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano za vezavo na receptorje (prijemališča), imenovane receptorji interlevkina-5, na površini eozinofilcev.
English: Fasenra activates the immune system (the body's natural defences) to kill the eosinophils in the blood and lungs.
Slovenian: interlevkina-5 aktivira imunski sistem (naravno obrambo telesa), da uniči eozinofilce v krvi in pljučih.
English: Fasenra has been shown to be more effective than placebo at reducing the number of asthma flare-ups and the need for corticosteroid treatment.
Slovenian: Zdravilo Fasenra se je pri zmanjševanju števila zagonov astme in potrebe po zdravljenju s kortikosteroidi izkazalo za učinkovitejše od placeba.
English: For the full list of side effects and restrictions of Fasenra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Fasenra glejte navodilo za uporabo.
English: Fasenra is an asthma medicine used to treat adults with a particular type of asthma called eosinophilic asthma.
Slovenian: Zdravilo Fasenra je zdravilo za astmo, ki se uporablja za zdravljenje odraslih s posebno vrsto astme, imenovano eozinofilna astma.
English: In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs.
Slovenian: Simptomi pri eozinofilni astmi so povezani s prevelikim številom določene vrste belih krvnih celic, imenovanih eozinofilci, v krvi in pljučni sluzi.
English: Fasenra is available as a solution for injection in pre-filled syringes and pre-filled pens.
Slovenian: Zdravilo Fasenra je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi ali peresniku.
English: How is Fasenra used?
Slovenian: Kako se zdravilo Fasenra uporablja?
English: How does Fasenra work?
Slovenian: Kako zdravilo Fasenra deluje?
English: Fasenra contains the active substance benralizumab.
Slovenian: Vsebuje učinkovino benralizumab.
English: Fasenra was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving a total of 2,511 patients with eosinophilic asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and long-acting beta-agonists.
Slovenian: V dveh glavnih študijah, v kateri je bilo skupno vključenih 2 511 bolnikov z eozinofilno astmo, ki ni bila ustrezno nadzorovana s kombinacijo velikih odmerkov inhalacijskih kortikosteroidov in dolgodelujočih agonistov beta, so dokazali, da zdravljenje z zdravilom Fasenra zmanjša število poslabšanj (zagonov) astme.
English: When should I seek advice or help?
Slovenian: Kdaj naj poiščem nasvet ali pomoč?
English: What can I do to help relieve my symptoms?
Slovenian: Kaj lahko storim, za olajšanje simptomov?
English: Why do you get these symptoms?
Slovenian: Zakaj se pojavijo ti simptomi?
English: Do not use any other liquids.
Slovenian: Ne uporabljajte nobenih drugih tekočin.
English: This could be a sign of a serious condition with your heart.
Slovenian: To je lahko znak resnega stanja povezanega z vašim srcem.
English: If you forget to take a dose, take it as soon as you remember it, on the same day.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, v istem dnevu.
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 25 June 2018
Slovenian: Datum prve odobritve: 26. avgust 2013 Datum zadnjega podaljšanja: 25. junij 2018
English: Children and adolescents This medicine should not be used by children and adolescents under 18 years of age.
Slovenian: Tega zdravila ne smejo jemati otroci in mladostniki, mlajši od 18 let.
English: Always stir the mixture just before drinking it.
Slovenian: Mešanico vedno premešajte, tik preden jo popijete.
English: • Avoid fizzy drinks, coffee, chocolate and alcohol.
Slovenian: • izogibajte se gaziranim pijačam, kavi, čokoladi in alkoholu;
English: • Eat slowly and eat smaller portions.
Slovenian: • jejte počasi in uživajte manjše obroke;
English: This is because this medicine can affect the way some medicines work and some medicines can have an effect on it.
Slovenian: To zdravilo namreč lahko vpliva na delovanje nekaterih zdravil in nekatera zdravila lahko vplivajo na to zdravilo.
English: • Stir until the tablet breaks up (the mixture will not be clear) then drink the mixture straight away or within 30 minutes.
Slovenian: • Mešajte, dokler se tableta ne razpusti (mešanica ne bo bistra), nato mešanico popijte takoj ali v 30 minutah.
English: In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations.
Slovenian: Poleg tega so varnostne značilnosti podobne za različne farmacevtske oblike, indikacije zdravljenja, starostne skupine in populacije bolnikov.
English: FURTHER HELPFUL INFORMATION
Slovenian: DODATNE KORISTNE INFORMACIJE
English: • You are due to have a specific blood test (Chromogranin A).
Slovenian: • ste naročeni na specifično preiskavo krvi (kromogranin A).
English: General Patients should be instructed to consult a doctor if:
Slovenian: Splošno Bolnikom je treba naročiti, naj se posvetujejo z zdravnikom:
English: • Eat healthier food and try to avoid spicy and fatty foods and large meals late before bedtime.
Slovenian: • Uživajte bolj zdravo hrano in se izogibajte začinjeni ter mastni hrani in velikim obrokom pred spanjem;
English: The duration of treatment is up to 2 weeks.
Slovenian: Zdravljenje traja do 2 tedna.
English: The majority of these rated the importance of this change to be Important to Extremely Important in performing their activities of daily living (79 - 86% at week 2).
Slovenian: Večina teh bolnikov je ocenila spremembo kot pomembno do izredno pomembno za opravljanje vsakodnevnih dejavnosti (79 - 86 % 2. teden).
English: If any of the above apply to you (or you are not sure), talk to your doctor straight away.
Slovenian: Če kaj od naštetega velja za vas (ali če niste prepričani), se takoj posvetujte z zdravnikom.
English: • Stop smoking.
Slovenian: • prenehajte kaditi.
English: • The treatment length is up to 14 days.
Slovenian: • Zdravljenje traja do 14 dni.
English: Poor metabolisers
Slovenian: Slabi metabolizatorji
English: Treatment should be symptomatic and general supportive measures should be utilised.
Slovenian: Zdravljenje mora biti simptomatsko, z uporabo splošnih podpornih ukrepov.
English: The clinical importance and the mechanisms behind these reported interactions are not always known.
Slovenian: Klinični pomen in mehanizmi teh opisanih medsebojnih delovanj niso vedno znani.
English: Less than 1% of the parent compound is found in urine.
Slovenian: V urinu se pojavi manj kot 1 % matičnega zdravila.
English: • Seeing, feeling or hearing things that are not there (hallucinations)
Slovenian: • videnje, občutenje ali slišanje stvari, ki jih ni (halucinacije)