FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Kuvan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kuvan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Two other studies in 101 patients looked at how effective Kuvan was at allowing the patients to consume foods containing phenylalanine while keeping blood phenylalanine at target levels (i.e. phenylalanine tolerance).
Slovenian: V drugih dveh študijah, v katerih je sodeloval 101 bolnik, so proučevali učinkovitost zdravila pri tem, da bolnikom omogoči uživanje hrane, ki vsebuje fenilalanin, hkrati pa njegovo raven v krvi ohranja na ciljni ravni (tj. toleranca na fenilalanin).
English: The starting dose of Kuvan depends on the patient's weight.
Slovenian: Začetni odmerek je odvisen od bolnikove telesne mase.
English: How does Kuvan work?
Slovenian: Kako zdravilo Kuvan deluje?
English: For some patients with BH4 deficiency, the dose may need to be divided into two or three doses over the course of the day to get the best effect.
Slovenian: Za dosego najboljšega učinka bo pri nekaterih bolnikih s pomanjkanjem BH4 odmerek morda treba razdeliti na dva ali tri dele, ki jih bolnik vzame čez dan.
English: Patients with PKU have defective versions of the enzyme, and patients with BH4 deficiency have low levels of BH4, a ‘cofactor' that this enzyme needs to work properly.
Slovenian: Bolniki s fenilketonurijo imajo okvarjeno različico encima, bolniki s pomanjkanjem BH4 pa nizko raven kofaktorja BH4, ki ga encim potrebuje za pravilno delovanje.
English: Because the number of patients with conditions leading to high phenylalanine levels is low, the conditions are considered ‘rare', and Kuvan was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2004.
Slovenian: Ker je bolnikov z boleznimi, ki vodijo do visoke ravni fenilalanina v krvi, malo, veljata bolezni za redki, zato je bilo zdravilo Kuvan 8. junija 2004 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: Kuvan is a medicine that is used to treat high blood levels of phenylalanine in adults and children of all ages with the genetic disorders phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.
Slovenian: Zdravilo Kuvan se uporablja za zdravljenje visoke ravni fenilalanina v krvi pri odraslih in otrocih vseh starosti z genskima motnjama fenilketonurijo (PKU) ali pomanjkanjem tetrahidrobiopterina (BH4).
English: For practical information about using Kuvan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Kuvan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The active substance in Kuvan, sapropterin dihydrochloride, is a synthetic copy of BH4.
Slovenian: Zdravilna učinkovina zdravila Kuvan, sapropterinijev dihidroklorid, je sintetična kopija BH4.
English: Kuvan can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in treating PKU and BH4 deficiency.
Slovenian: Predpisovanje in izdaja zdravila Kuvan je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem PKU in pomanjkanja BH4.
English: In PKU, it works by enhancing the activity of the defective enzyme, while in BH4 deficiency it replaces the missing cofactor.
Slovenian: Pri fenilketonuriji deluje tako, da poveča aktivnost okvarjenega encima, pri pomanjkanju BH4 pa nadomesti manjkajoči kofaktor.
English: How is Kuvan used?
Slovenian: Kako se zdravilo Kuvan uporablja?
English: Patients with these disorders cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.
Slovenian: Bolniki s tema boleznima ne morejo razgraditi aminokisline fenilalanin, ki je prisotna v beljakovinah v hrani, zaradi česar se ta kopiči v krvi in dosega neobičajno visoko raven, kar povzroča težave z živčnim sistemom.
English: For the full list of all side effects and restrictions with Kuvan, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Kuvan glejte navodilo za uporabo.
English: These actions help restore the ability of the enzyme to convert phenylalanine into tyrosine, thereby reducing phenylalanine levels in the blood.
Slovenian: S tem se ponovno vzpostavi sposobnost encima, da pretvarja fenilalanin v tirozin, s čimer se zniža raven fenilalanina v krvi.
English: In addition Kuvan allowed patients with PKU who were not on a restricted diet to increase their daily phenylalanine intake by 17.5 mg per kg body weight after 10 weeks compared with 3.3 mg/kg with placebo.
Slovenian: Poleg tega so bolniki s fenilketonurijo, ki niso imeli omejene prehrane in so se zdravili z zdravilom Kuvan, po desetih tednih lahko povečali dnevni vnos fenilalanina za 17,5 mg na kilogram telesne mase, v primerjavi s 3,3 mg/kg pri osebah, ki so prejemale placebo.
English: When Kuvan plus diet restriction was compared with diet restriction alone, the average daily phenylalanine intake that was tolerated after 26 weeks was 81 mg/kg in the Kuvan group and 50 mg/kg in the group on diet restriction alone.
Slovenian: V primerjavi med bolniki, ki so se zdravili z zdravilom Kuvan in s prehranskimi omejitvami, ter osebami, ki so se zdravile zgolj s prehranskimi omejitvami, je bil v prvi skupini po 26 tednih povprečni tolerirani dnevni vnos fenilalanina 81 mg/kg, v drugi skupini pa 50 mg/kg.
English: The high levels of phenylalanine in the blood are due to a problem with the breakdown of phenylalanine through the enzyme ‘phenylalanine hydroxylase'.
Slovenian: Visoke ravni fenilalanina v krvi so posledica težav pri pretvarjanju fenilalanina s pomočjo encima fenilalanin hidroksilaze.
English: Kuvan contains the active substance sapropterin dihydrochloride.
Slovenian: Zdravilo Kuvan vsebuje zdravilno učinkovino sapropterinijev dihidroklorid.
English: The dose is then adjusted depending on blood levels of amino acids including phenylalanine.
Slovenian: Nato se prilagodi glede na raven aminokislin, vključno s fenilaninom, v krvi.
English: In PKU treatment, a main study compared the reductions in blood phenylalanine in 88 patients treated with either Kuvan or placebo (a dummy treatment).
Slovenian: Pri zdravljenju fenilketonurije so v glavni študiji, v kateri je sodelovalo 88 bolnikov, ki so prejemali bodisi zdravilo Kuvan bodisi placebo (zdravilo brez zdravilne učinkovine), primerjali znižanje ravni fenilalanina v krvi.
English: Kuvan was more effective than placebo at reducing blood phenylalanine levels in patients with PKU, achieving a reduction of 236 micromoles per litre after 6 weeks compared with an increase of 3 micromoles per litre seen with placebo.
Slovenian: Po šestih tednih se je raven fenilalanina znižala za 236 mikromolov na liter, pri osebah, ki so prejemale placebo, pa se je zvišala za 3 mikromole na liter.
English: It is important that patients continue with a diet low in phenylalanine and protein when taking Kuvan, and intake of phenylalanine and protein must be monitored and adjusted to make sure that blood phenylalanine levels and nutritional balance are controlled.
Slovenian: Pomembno je, da bolniki med zdravljenjem nadaljujejo z uživanjem prehrane z nizko vsebnostjo fenilalanina in beljakovin.
English: Further information on Yescarta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Yescarta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Serious side effects occur in more than 1 in 2 patients.
Slovenian: Resni neželeni učinki se lahko pojavijo pri več kot 1 od 2 bolnikov.
English: The company must also carry out a study to obtain more information on the long term safety of Yescarta.
Slovenian: Podjetje mora tudi izvesti študijo za pridobitev več informacij o dolgoročni varnosti zdravila Yescarta.
English: The European Medicines Agency therefore decided that Yescarta'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 Yescarta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Patients should be closely monitored for 10 days after treatment for side effects and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.
Slovenian: Bolnike je treba deset dni po zdravljenju skrbno spremljati glede neželenih učinkov in jim priporočiti, da ostanejo blizu specialistične bolnišnice še vsaj štiri tedne po zdravljenju.
English: What measures are being taken to ensure the safe and effective use of Yescarta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Yescarta?
English: Yescarta is a medicine for treating two types of blood cancer:
Slovenian: Yescarta je zdravilo, ki se uporablja za zdravljenje krvnega raka dveh vrst:
English: Yescarta (axicabtagene ciloleucel)
Slovenian: Yescarta (aksicabtagen ciloleucel)
English: As for all medicines, data on the use of Yescarta are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Yescarta stalno spremljajo.
English: The most common serious side effects are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), encephalopathy (a brain disorder caused associated with headache, somnolence and mental confusion) and infections.
Slovenian: Najpogostejši resni neželeni učinki so sindrom sproščanja citokinov (potencialno smrtno nevarno stanje, ki lahko povzroči vročino, bruhanje, zasoplost, bolečino in nizek krvni tlak), encefalopatija (možganska motnja, povezana z glavobolom, zaspanostjo in zmedenostjo) ter okužbe.
English: The number of patients who were cleared of the cancer or had at least a partial response was higher than in patients receiving standard care.
Slovenian: Število bolnikov, pri katerih je bil rak odstranjen ali je prišlo do vsaj delnega odziva, je bilo višje kot pri bolnikih, ki so prejemali standardno zdravljenje.
English: Side effects reported with Yescarta are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Yescarta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Other information about Yescarta
Slovenian: Druge informacije o zdravilu Yescarta
English: What benefits of Yescarta have been shown in studies?
Slovenian: Kakšne koristi zdravila Yescarta so se pokazale v študijah?
English: For more information about using Yescarta, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Yescarta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Yescarta authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Yescarta odobreno v EU?
English: CAR can attach to another protein on the surface of cancer cells called CD19.
Slovenian: CAR se lahko veže na drugo beljakovino na površini rakavih celic, imenovano CD19.
English: An overview of Yescarta and why it is authorised in the EU
Slovenian: Pregled zdravila Yescarta in zakaj je odobreno v EU
English: What is Yescarta and what is it used for?
Slovenian: Kaj je zdravilo Yescarta in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yescarta 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 Yescarta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Serious side effects, particularly cytokine release syndrome, can occur; however these are manageable if appropriate measures are in place (see below).
Slovenian: Lahko se pojavijo resni neželeni učinki, zlasti sindrom sproščanja citokinov, vendar so ob ustreznih ukrepih (glejte v nadaljevanju) obvladljivi.
English: Of the patients who joined the study, 47% had a complete response (which means they had no signs of the cancer left) and 66% had at least a partial response after treatment with Yescarta.
Slovenian: Pri 47 % bolnikov, ki so se pridružili študiji, je prišlo do popolnega odziva (kar pomeni, da niso več imeli znakov raka), pri 66 odstotkih bolnikov pa je po zdravljenju z zdravilom Yescarta prišlo do vsaj delnega odziva.
English: The company that markets Yescarta must ensure that hospitals where Yescarta is given have appropriate expertise, facilities and training.
Slovenian: Podjetje, ki trži zdravilo Yescarta, mora zagotoviti, da je v bolnišnicah, v katerih se daje to zdravilo, na voljo ustrezna oprema ter ima osebje ustrezno strokovno znanje in izkušnje in je ustrezno usposobljeno.
English: These results were better than those from studies of patients receiving standard cancer treatments, where around 7% of patients had a complete response and around 26% had at least a partial response.
Slovenian: Ti izidi so bili boljši kot izidi študij pri bolnikih, ki so prejemali standardna zdravila proti raku, saj je do popolnega odziva prišlo pri 7 % teh bolnikov, do vsaj delnega odziva pa pri 26 % bolnikov.
English: What are the risks associated with Yescarta?
Slovenian: Kakšna tveganja so povezana z zdravilom Yescarta?
English: Yescarta is for adult patients whose blood cancer has returned or has stopped responding to previous treatment.
Slovenian: Zdravilo Yescarta je namenjeno odraslim bolnikom, pri katerih se je krvni rak ponovil ali se je prenehal odzivati na predhodno zdravljenje.
English: When Yescarta is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body.
Slovenian: Po dajanju zdravila Yescarta bolniku se spremenjene celice T pritrdijo na rakave celice in jih uničijo, s tem pa pripomorejo k odstranjevanju raka iz telesa.
English: A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).
Slovenian: Na voljo morata biti zdravilo tocilizumab in nujna medicinska oprema za primer, da bi se pri bolniku pojavil resen neželeni učinek, imenovan sindrom sproščanja citokinov (glejte oddelek o tveganjih v nadaljevanju).
English: A main study of 111 patients with DLBCL and PMBCL that was not responding to previous treatment or had returned showed that Yescarta is effective at clearing the cancer in many patients.
Slovenian: Glavna študija pri 111 bolnikih z difuznim velikoceličnim B-limfomom ali primarnim mediastinalnim velikoceličnim B-limfomom, ki se nista odzvala na predhodno zdravljenje ali sta se ponovila, je pokazala, da zdravilo Yescarta pri številnih bolnikih učinkovito odstrani raka.
English: Yescarta contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR).
Slovenian: Zdravilo Yescarta vsebuje bolnikove lastne celice T (vrsto belih krvnih celic), ki so bile v laboratoriju gensko spremenjene tako, da tvorijo beljakovino, imenovano himerni antigenski receptor (CAR).
English: For the full list of side effects and restrictions with Yescarta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Yescarta glejte navodilo za uporabo.
English: Yescarta is a type of advanced therapy medicine called a ‘gene therapy product'.
Slovenian: Zdravilo Yescarta spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila za gensko zdravljenje“.
English: The blood cancers that Yescarta is used to treat are rare, and Yescarta was designated an ‘orphan medicine' (a medicine used in rare diseases) for DLBCL on 16 December 2014 and for PMBCL on 9 October 2015.
Slovenian: Obliki krvnega raka, za kateri se uporablja zdravilo Yescarta, sta redki, zato je bilo zdravilo Yescarta 16. decembra 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje difuznega velikoceličnega B-limfoma in 9. oktobra 2015 kot „zdravilo sirota“ za zdravljenje primarnega mediastinalnega velikoceličnega B-limfoma.
English: Yescarta is prepared using the patient's own white blood cells which are extracted from the blood and genetically modified in the laboratory.
Slovenian: Zdravilo Yescarta se pripravi iz bolnikovih lastnih belih krvnih celic, pridobljenih iz krvi in gensko spremenjenih v laboratoriju.
English: It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Yescarta, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.
Slovenian: Pred prejemom zdravila Yescarta je treba bolnika kratkotrajno zdraviti s kemoterapijo, da se iz krvi odstranijo obstoječe bele krvne celice, tik pred infuzijo pa bolnik prejme še paracetamol in antihistaminik za zmanjšanje tveganja reakcije na infuzijo.
English: • primary mediastinal large B-cell lymphoma (PMBCL).
Slovenian: • primarnega mediastinalnega velikoceličnega B-limfoma.
English: Yescarta contains the active substance axicabtagene ciloleucel (consisting of genetically modified white blood cells).
Slovenian: Zdravilo Yescarta vsebuje učinkovino aksicabtagen ciloleucel (ta vsebuje gensko spremenjene bele krvne celice).
English: • diffuse large B-cell lymphoma (DLBCL);
Slovenian: • difuznega velikoceličnega B-limfoma;
English: A main study showed that Yescarta is effective at clearing the cancer in many patients with DLBCL and PMBCL that was not responding to previous treatment or had returned.
Slovenian: Glavna študija je pokazala, da zdravilo Yescarta učinkovito odstrani raka pri številnih bolnikih z difuznim velikoceličnim B-limfomom ali primarnim mediastinalnim velikoceličnim B-limfomom, ki se nista odzvala na predhodno zdravljenje ali sta se ponovila.
English: How is Yescarta used?
Slovenian: Kako se zdravilo Yescarta uporablja?
English: How does Yescarta work?
Slovenian: Kako zdravilo Yescarta deluje?
English: Two other studies have shown similar results.
Slovenian: Dve drugi študiji sta dali podobne rezultate.
English: Please consult your doctor if you plan to become pregnant.
Slovenian: Prosimo, posvetujte se s svojim zdravnikom, če načrtujete nosečnost.
English: Do not increase or decrease the amount of medicine without your doctor's approval.
Slovenian: Ne povečujte ali zmanjšujte količine zdravila brez odobritve svojega zdravnika.
English: The potential risk for humans is unknown.
Slovenian: Potencialno tveganje za človeka pa ni znano.
English: It is important to take the dose as close to every 6 hours as possible.
Slovenian: Pomembno je jemati odmerke kar se da točno vsakih 6 ur.
English: Approximately 35% of patients can be expected to experience adverse reactions.
Slovenian: Pri približno 35 % bolnikov lahko pričakujemo pojav neželenih učinkov.
English: Your or your child's doctor will arrange for the blood tests to be done.
Slovenian: Vaš ali otrokov zdravnik bo odredil izvajanje krvnih testov.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Slovenian: NAVODILO ZA UPORABO: INFORMACIJEZA UPORABNIKA
English: In all studies, patient response was better when treatment was started at an early age with good renal function.
Slovenian: V vseh študijah je bil odgovor bolnikov boljši, kadar se je zdravljenje začelo v zgodnji starosti, ob ustrezno dobrem delovanju ledvic.
English: If a dose of medicine is missed, it should be taken as soon as possible.
Slovenian: Če je bil odmerek zdravila izpuščen, ga je treba vzeti kakor hitro je to mogoče.
English: CYSTAGON may cause some people to become drowsy or less vigilant than they are normally.
Slovenian: CYSTAGON lahko pri nekaterih ljudeh povzroči, da postanejo zaspani ali manj pozorni kot običajno.
English: Very common: Anorexia
Slovenian: Zelo pogosto: anoreksija
English: No interaction studies have been performed
Slovenian: Študij medsebojnega delovanja niso izvedli.
English: Do not add to acidic drinks e.g. orange juice.
Slovenian: Ne dodajajte zdravila kislim pijačam, npr. pomarančnemu soku.
English: black ink on hard capsules containing E172
Slovenian: črnilo na trdi kapsuli, ki vsebuje E172.
English: Different organs are affected at different ages.
Slovenian: Prizadetost različnih organov se pokaže v različnih starostih bolnika.
English: Should overdosage occur, the respiratory and cardiovascular systems should be supported appropriately.
Slovenian: Če pride do prevelikega odmerjanja, je treba uvesti ustrezno respiratorno in kardiovaskularno podporno zdravljenje.
English: When these effects appear at the initiation of cysteamine therapy, temporary suspension and gradual reintroduction of treatment may be effective in improving tolerance.
Slovenian: Kadar se ti učinki pojavijo ob uvedbi zdravljenja s cisteaminom, lahko začasna prekinitev in ponovno postopno uvajanje terapije učinkovito izboljša toleranco.
English: - Your or your child's medical treatment may include, in addition to CYSTAGON, one or more supplements to replace important electrolytes lost through the kidneys.
Slovenian: - Vaše ali otrokovo zdravljenje lahko vključuje poleg CYSTAGONa še enega ali več dodatkov za nadomeščanje pomembnih elektrolitov, ki se izgubljajo skozi ledvice.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriouness
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Consult the doctor for complete directions.
Slovenian: Za podrobnejša navodila se posvetujte z zdravnikom.
English: It is important to take or give these supplements exactly as instructed.
Slovenian: Važno je, da se ti dodatki dajejo oz. jemljejo točno po navodilih.
English: No information is available for patients with severe renal insufficiency.
Slovenian: Ni na razpolago podatkov za bolnike s hudo okvaro ledvic.
English: The principal efficacy measurements were serum creatinine and calculated creatinine clearance and growth (height).
Slovenian: Glavna merila učinkovitosti so bila: serumski kreatinin, izračunani očistek kreatinina in rast (višina).
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Slovenian: V študijah na živalih je bila ugotovljena reproduktivna toksičnost vključno s teratogenezo (glejte poglavje 5.3).
English: If you use more CYSTAGON than you should:
Slovenian: Če ste uporabili večji odmerek zdravila CYSTAGON, kot bi smeli:
English: CYSTAGON should be taken 4 times a day, every 6 hours, preferably just after or with food.
Slovenian: CYSTAGON je treba jemati 4-krat na dan, vsakih 6 ur, po možnosti takoj po jedi ali med jedjo.
English: CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells.
Slovenian: CYSTAGON je zdravilo, ki reagira s cistinom in tako znižuje njegovo raven znotraj celic.
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: The dose of CYSTAGON prescribed for you or your child will depend on your or your child's age and weight.
Slovenian: Odmerek CYSTAGONa, ki ga predpišejo vam ali vašemu otroku, bo odvisen od starosti in telesne teže vas samih ali vašega otroka.