FrancophonIA/ELRC3.0 huggingface dataset:
English: To avoid the risk of developing kidney stones, patients should drink plenty of liquids (at least 1.5 litres every day for adults).
Slovenian: Za zmanjšanje tveganja nastanka ledvičnih kamnov morajo bolniki piti veliko tekočine (najmanj 1,5 litra na dan za odraslo osebo).
English: The full EPAR for Crixivan 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 Crixivan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Crixivan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Crixivan?
English: This is a summary of the European public assessment report (EPAR) for Crixivan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Crixivan.
English: Other information about Crixivan
Slovenian: Druge informacije o zdravilu Crixivan
English: The most common side effects with Crixivan (seen in more than 1 patient in 10) are increases in size of red blood cells, decreases in neutrophils (a type of white blood cell), headache, dizziness, nausea (feeling sick), vomiting, diarrhoea, heartburn, instances of high blood bilirubin levels that do not cause any symptoms, increased levels of liver enzymes (alanine and aspartate transaminases), rash, dry skin, blood in the urine, protein in the urine, crystals in the urine, weakness or tiredness, an altered sense of taste and abdominal pain (stomach ache).
Slovenian: Najpogostejši neželeni učinki zdravila Crixivan (opaženi pri več kot enem bolniku od 10) so povečanje velikosti rdečih krvnih celic, zmanjšanje števila nevtrofilcev (vrste belih krvnih celic), glavobol, omotica, slabost, bruhanje, driska, zgaga, pojavi visokih ravni bilirubina v krvi, ki ne povzročajo nobenih simptomov, povečane ravni jetrnih encimov (alanina in aspartat transaminaz), izpuščaji, suha koža, kri v urinu, beljakovine v urinu, kristali v urinu, šibkost ali utrujenost, spremenjeno okušanje in bolečine v trebuhu (bolečine v želodcu).
English: The CHMP decided that Crixivan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Crixivan večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The standard dose is 800 mg every eight hours, but Crixivan can also be taken at a dose of 400 mg twice a day if each dose is taken with 100 mg ritonavir (another antiviral medicine).
Slovenian: Standardni odmerek zdravila Crixivan je 800 mg vsakih osem ur, lahko pa se jemlje tudi v odmerku 400 mg dvakrat dnevno, če se vsak odmerek vzame sočasno s 100 mg ritonavirja (drugega protivirusnega zdravila).
English: It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Slovenian: Ta zavira encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
English: In one study, 90% of those taking Crixivan in combination with zidovudine and lamivudine had viral loads below 500 copies/ml after 24 weeks of treatment, compared with 43% of those taking Crixivan alone and none (0%) of those taking zidovudine and lamivudine without Crixivan.
Slovenian: V eni študiji je 90 % bolnikov, ki so jemali zdravilo Crixivan v kombinaciji z zidovudinom in lamivudinom, imelo po 24 tednih zdravljenja virusno obremenitev pod 500 kopij/ml v primerjavi s 43 % tistih, ki so jemali samo zdravilo Crixivan, in 0 % tistih, ki so jemali zidovudin in lamivudin brez zdravila Crixivan.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Crixivan 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 Crixivan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Crixivan is available as capsules (200 and 400 mg) and is taken by mouth one hour before or two hours after a meal with water or a light low-fat meal.
Slovenian: Zdavilo Crixivan je na voljo v obliki kapsul (200 in 400 mg) in se jemlje peroralno eno uro pred obrokom ali dve uri po njem, in sicer z vodo ali lažjim obrokom z nizko vsebnostjo maščob.
English: Crixivan must not be taken with certain other medicines because of the possibility of harmful interactions.
Slovenian: Zdravilo Crixivan se ne sme jemati z nekaterimi drugimi zdravili zaradi možnosti škodljivih medsebojnih učinkov.
English: It is not intended to provide practical advice on how to use Crixivan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Studies have shown that Crixivan in combination with other antiviral medicines is effective at reducing the level of HIV in the blood (viral load).
Slovenian: Študije so pokazale, da je zdravilo Crixivan v kombinaciji z drugimi protivirusnimi zdravili učinkovito pri zmanjševanju ravni virusa HIV v krvi (virusnega bremena).
English: For more information about treatment with Crixivan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Crixivan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Crixivan is an antiviral medicine for treating adults infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Crixivan je protivirusno zdravilo za zdravljenje odraslih, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: What benefits of Crixivan have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Crixivan izkazalo v študijah?
English: Ritonavir, another protease inhibitor, is sometimes used with Crixivan as a ‘booster'.
Slovenian: Ritonavir, ki je prav tako zaviralec proteaze, se včasih uporablja skupaj z zdravilom Crixivan kot „ojačevalec“.
English: What is Crixivan and what is it used for?
Slovenian: Kaj je zdravilo Crixivan in za kaj se uporablja?
English: Crixivan does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Crixivan ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: What are the risks associated with Crixivan?
Slovenian: Kakšna tveganja so povezana z zdravilom Crixivan?
English: By blocking this enzyme, indinavir stops the virus from reproducing normally and thereby slows down the spread of infection.
Slovenian: Indinavir z zaviranjem proteaze prepreči normalno razmnoževanje virusa in tako upočasni širitev okužbe.
English: Why is Crixivan been approved?
Slovenian: Zakaj je bilo zdravilo Crixivan odobreno?
English: For practical information about using Crixivan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Crixivan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The active substance in Crixivan, indinavir, is a protease inhibitor.
Slovenian: Zdravilna učinkovina zdravila Crixivan, indinavir, je zaviralec proteaze.
English: Crixivan should only be prescribed by doctors with experience in treating HIV and can only be obtained by prescription.
Slovenian: Zdravilo Crixivan lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV, izdaja tega zdravila pa je le na recept.
English: It slows down the rate at which indinavir is broken down, helping to increase levels of indinavir in the blood.
Slovenian: Ker upočasni hitrost razgradnje indinavirja, s tem zviša njegove ravni v krvi.
English: Crixivan is used in combination with other antiviral medicines and contains the active substance indinavir.
Slovenian: Zdravilo Crixivan se uporablja v kombinaciji z drugimi protivirusnimi zdravili, vsebuje pa zdravilno učinkovino indinavir.
English: For the full list of side effects reported with Crixivan, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Crixivan, glejte navodilo za uporabo.
English: How is Crixivan used?
Slovenian: Kako se zdravilo Crixivan uporablja?
English: How does Crixivan work?
Slovenian: Kako zdravilo Crixivan deluje?
English: The frequency of injections is adjusted again after 6 and 9 months depending on how well the medicine is working.
Slovenian: Pogostost injiciranja se ponovno prilagodi po šestih in devetih mesecih, odvisno od tega, kako dobro zdravilo deluje.
English: At the start of treatment, Waylivra is given once a week.
Slovenian: Na začetku zdravljenja se zdravilo Waylivra daje enkrat na teden.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
English: What measures are being taken to ensure the safe and effective use of Waylivra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Waylivra?
English: Patients must therefore be monitored closely and the frequency of injections adjusted if needed.
Slovenian: Zato je treba bolnike pozorno spremljati in po potrebi prilagoditi število injiciranj.
English: Further information on Waylivra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/waylivra.
Slovenian: Nadaljnje informacije o zdravilu Waylivra so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/waylivra.
English: An overview of Waylivra and why it is authorised in the EU
Slovenian: Pregled zdravila Waylivra in zakaj je odobreno v EU
English: Depending on the results, frequency of injections may be adjusted, or treatment paused or discontinued.
Slovenian: Glede na rezultate je mogoče pogostost injiciranja prilagoditi ali zdravljenje začasno prekiniti ali ukiniti.
English: As for all medicines, data on the use of Waylivra are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Waylivra stalno spremljajo.
English: Why is Waylivra authorised in the EU?
Slovenian: Zakaj je zdravilo Waylivra odobreno v EU?
English: After 3 months, patients who have had a sufficient reduction in the level of triglycerides can continue to receive the medicine once every 2 weeks.
Slovenian: Po treh mesecih lahko bolniki, pri katerih so se ravni trigliceridov zadostno znižale, zdravilo prejemajo vsaka dva tedna.
English: The main risk with this medicine is thrombocytopenia which, when severe, can lead to bleeding.
Slovenian: Glavno tveganje pri tem zdravilu je trombocitopenija, ki lahko, kadar je huda, povzroči krvavitve.
English: The most common side effects with Waylivra are reduced platelet levels (which may affect 4 in 10 people) and reactions at the site of the injection such as pain, swelling, itching, or bruising (which may affect 8 in 10 people).
Slovenian: Najpogostejši neželeni učinki zdravila Waylivra so zmanjšane ravni trombocitov (ki se lahko pojavijo pri 4 od 10 bolnikov) in reakcije na mestu injiciranja, kot so bolečina, otekanje, srbenje ali podplutbe (ki se lahko pojavijo pri 8 od 10 bolnikov).
English: Other information about Waylivra
Slovenian: Druge informacije o zdravilu Waylivra
English: Side effects reported with Waylivra are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Waylivra, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: It is only given to patients in whom other medicines to reduce triglycerides have not worked and who are at high risk of developing pancreatitis.
Slovenian: Prejemajo ga lahko samo bolniki, pri katerih druga zdravila za zmanjšanje trigliceridov niso delovala in pri katerih obstaja veliko tveganje za razvoj pankreatitisa.
English: Waylivra has been given ‘conditional authorisation'.
Slovenian: Zdravilo Waylivra je pridobilo „pogojno dovoljenje za promet“.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Waylivra 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 Waylivra upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Waylivra, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Waylivra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Excess fat builds up in various parts of the body and leads to symptoms including abdominal pain (belly ache), deposits of fat under the skin and pancreatitis (inflammation of the pancreas).
Slovenian: Presežna maščoba se kopiči v različnih delih telesa in pri tem povzroča simptome, kot so bolečine v trebuhu, nalaganje maščobe pod kožo in pankreatitis (vnetje trebušne slinavke).
English: Waylivra is available as a solution for injection under the skin, which patients or their carers can inject themselves once they have been trained.
Slovenian: Zdravilo Waylivra je na voljo kot raztopina za injiciranje pod kožo, ki jo bolniki ali njihovi negovalci po ustreznem usposabljanju lahko injicirajo sami.
English: What is Waylivra and what is it used for?
Slovenian: Kaj je zdravilo Waylivra in za kaj se uporablja?
English: The European Medicines Agency decided that, for patients at high risk of pancreatitis and for whom other medicines and a low-fat diet have not worked well enough, Waylivra's benefits are greater than its risks and that it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Waylivra za bolnike, pri katerih obstaja veliko tveganje za pankreatitis in pri katerih druga zdravila in prehrana z nizko vrednostjo maščob niso dovolj učinkoviti, večje od z njim povezanih tveganj, in da se lahko odobri za uporabo v EU.
English: The active substance in Waylivra, volanesorsen, is an ‘antisense oligonucleotide,' a very short piece of synthetic RNA (a type of genetic material).
Slovenian: Učinkovina v zdravilu Waylivra, volanesorsen, je „protismerni oligonukleotid“, zelo kratek košček sintetične RNK (vrste genskega materiala).
English: After 3 months, patients given Waylivra had an average 77% reduction in the level of triglycerides compared with an average 18% reduction in patients given placebo (a dummy treatment).
Slovenian: Po treh mesecih so se pri bolnikih, ki so jemali zdravilo Waylivra, ravni trigliceridov v povprečju zmanjšale za 77 % v primerjavi s povprečnim zmanjšanjem za 18 % pri bolnikih, ki so prejemali placebo (zdravilo brez zdravilne učinkovine).
English: What are the risks associated with Waylivra?
Slovenian: Kakšna tveganja so povezana z zdravilom Waylivra?
English: What benefits of Waylivra have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Waylivra izkazalo v študijah?
English: Waylivra must not be used in patients who have long-term or unexplained thrombocytopenia (low blood platelet levels).
Slovenian: Zdravilo Waylivra se ne sme uporabljati pri bolnikih, ki imajo dolgotrajno ali nepojasnjeno trombocitopenijo (nizke ravni trombocitov v krvi).
English: FCS is rare, and Waylivra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 February 2014.
Slovenian: FCS je redka bolezen, zato je bilo zdravilo Waylivra 19. februarja 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Waylivra contains the active substance volanesorsen.
Slovenian: Zdravilo Waylivra vsebuje učinkovino volanesorsen.
English: Waylivra can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating FCS.
Slovenian: Izdaja zdravila je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem FCS.
English: Since Waylivra has been given conditional authorisation, the company that markets Waylivra will provide results of a study based on a registry of patients to investigate how blood checks and adjustments to frequency of injections are carried out in practice and how well they work to prevent thrombocytopenia and bleeding.
Slovenian: Ker je zdravilo Waylivra pridobilo pogojno dovoljenje, bo podjetje, ki ga trži, zagotovilo rezultate študije na podlagi registra bolnikov, s katero bo preučeno, kako se krvni pregledi in prilagoditve pogostosti injiciranja izvajajo v praksi ter kako dobro delujejo pri preprečevanju trombocitopenije in krvavitev.
English: Waylivra is a medicine used to treat familial chylomicronaemia syndrome (FCS), a genetic condition that gives rise to high levels of fats called triglycerides in the blood.
Slovenian: Waylivra je zdravilo, ki se uporablja za zdravljenje sindroma družinske hilomikronemije (FCS), tj. genetskega stanja, ki povzroča visoko raven maščob, imenovanih trigliceridi, v krvi.
English: All patients in the study were on a low fat diet in addition to receiving Waylivra or placebo.
Slovenian: Vsi bolniki v študiji so poleg jemanja zdravila Waylivra ali placeba uživali tudi hrano z nizko vsebnostjo maščobe.
English: The company that markets Waylivra will provide educational materials for patients and healthcare professionals with information on the risk of thrombocytopenia and bleeding with treatment and the importance of regularly checking platelet levels in patients.
Slovenian: Podjetje, ki trži zdravilo Waylivra, bo priskrbelo izobraževalno gradivo za bolnike in zdravstvene delavce z informacijami o tveganju za trombocitopenijo in krvavitve pri zdravljenju ter pomenu rednega preverjanja ravni trombocitov pri bolnikih.
English: What information is still awaited for Waylivra?
Slovenian: Katere informacije o zdravilu Waylivra še pričakujemo?
English: Waylivra effectively reduces triglyceride levels and is expected to reduce the risk of pancreatitis in patients with FCS.
Slovenian: Zdravilo Waylivra učinkovito zniža ravni trigliceridov in pričakuje se, da bo pri bolnikih z FCS zmanjšalo tveganje za pankreatitis.
English: For the full list of side effects and restrictions with Waylivra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Waylivra glejte navodilo za uporabo.
English: Waylivra, along with a low fat diet, is used to reduce triglyceride blood levels in patients with FCS that has been confirmed by genetic testing.
Slovenian: Zdravilo Waylivra, se skupaj s prehrano z nizko vsebnostjo maščob, uporablja za zmanjšanje ravni trigliceridov v krvi pri bolnikih s FCS, ki je bil potrjen z genetskim testiranjem.
English: Because Waylivra can reduce blood levels of platelets (components that help the blood to clot), patients' blood platelet levels should be checked regularly, in addition to regular checks of triglycerides to see how well the medicine is working.
Slovenian: Ker lahko zdravilo Waylivra zniža ravni trombocitov (komponent, ki pomagajo pri strjevanju krvi) v krvi, je treba poleg rednih pregledov trigliceridov, redno preverjati tudi bolnikove ravni trombocitov v krvi, da se ugotovi, kako dobro zdravilo deluje.
English: How does Waylivra work?
Slovenian: Kako zdravilo Waylivra deluje?
English: How is Waylivra used?
Slovenian: Kako se zdravilo Waylivra uporablja?
English: By blocking the production of this protein, the medicine reduces the level of triglycerides in the blood and, as a result, fat accumulation in the body, which is expected to reduce the risk of pancreatitis.
Slovenian: Zasnovan je bil tako, da zavira tvorjenje beljakovine, ki upočasnjuje razgradnjo maščob, imenovane apolipoprotein C-III. Z zaviranjem tvorjenja te beljakovine zdravilo zmanjša ravni trigliceridov v krvi in s tem kopičenje maščobe v telesu, kar naj bi zmanjšalo tveganje za pankreatitis.
English: Waylivra was effective in reducing triglycerides in the blood in a study of 67 patients with FCS.
Slovenian: Zdravilo Waylivra je bilo v študiji, v katero je bilo vključenih 67 bolnikov s FCS, uspešno pri zmanjšanju trigliceridov v krvi.
English: Close surveillance with regard to immunological reactions is especially important in such situations.
Slovenian: Natančno spremljanje glede imunoloških reakcij je v takšnih situacijah še posebno pomembno.
English: Antithrombin contains two functionally important domains.
Slovenian: Antitrombin vsebuje dve funkcionalno pomembni domeni.
English: The safety and efficacy of ATryn in children and adolescents (<18 years) have not been established.
Slovenian: Varnost in učinkovitost zdravila ATryn pri otrocih in mladostnikih (<18 let) nista bili dokazani.
English: The Physician educational material shall contain the following key elements:
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati naslednje ključne elemente:
English: The experience from repeated treatment with this medicine is very limited.
Slovenian: Izkušnje z večkratnim zdravljenjem s tem zdravilom so zelo omejene.
English: It is one of the most important natural inhibitors of blood coagulation.
Slovenian: Je eden najpomembnejših naravnih zaviralcev koagulacije krvi.
English: Mississauga, Ontario, Canada L5N 8H9
Slovenian: Mississauga, Ontario, Kanada L5N 8H9
English: • bleeding (at site of infusion or after surgery)
Slovenian: • krvavitev (na mestu infundiranja ali po operaciji),
English: This post-marketing surveillance will run up until such time as 40 patients are enrolled.
Slovenian: Pomarketinško spremljanje bo trajalo dokler ne bo vključenih 40 bolnikov.
English: Response may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Slovenian: Odziv se lahko pri posameznih bolnikih razlikuje, dosežene so različne ravni in vivo okrevanja in različne razpolovne dobe.
English: Patients treated with this medicine should be monitored for possible clinical immunological reactions.
Slovenian: Bolnike, zdravljene s tem zdravilom, je treba nadzorovati glede morebitnih kliničnih imunoloških reakcij.
English: • Information about the currently registered indications and population, including that the product is not indicated in the paediatric population.
Slovenian: • Informacije o trenutno odobrenih indikacijah in populaciji, vključno s podatkom, da zdravilo ni indicirano za uporabo pri pediatrični populaciji.
English: Paediatric antithrombin levels may be different from adult levels, particularly in neonates.
Slovenian: Pediatrične ravni antitrombina se lahko razlikujejo od ravni pri odraslih, zlasti pri novorojencih.
English: Frequency category
Slovenian: Kategorija pogostosti
English: After reconstitution, from a microbiological pointy of view, this medicinal product should be used immediately.
Slovenian: Po rekonstituciji je treba iz mikrobiološkega vidika to zdravilo takoj porabiti.
English: Date of first authorisation: 28 July 2006 Date of latest renewal: 15 July 2016
Slovenian: Datum zadnjega podaljšanja: 15. julij 2016
English: Antibody status should be monitored and reported.
Slovenian: Stanje protiteles je treba nadzorovati in zabeležiti.
English: • Clearance: 0.665 ± 0.0493 l/h (Mean ± SE)
Slovenian: • Očistek: 0,665 ± 0,0493 l/h (povprečje ± SE)
English: Do not use solutions that are cloudy or have deposits.
Slovenian: Ne uporabljajte raztopin, ki so motne ali imajo usedline.