FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Febuxostat Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Febuksostat Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What measures are being taken to ensure the safe and effective use of Febuxostat Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Febuksostat Mylan?
English: It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Slovenian: Deluje tako, da zavira encim, imenovan ksantinska oksidaza, ki je potreben za tvorbo sečne kisline v telesu.
English: Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Febuxostat Mylan.
Slovenian: V prvih nekaj mesecih zdravljenja še vedno lahko pride do zagonov protina, zato je priporočljivo, da bolnik vsaj prvih šest mesecev zdravljenja z zdravilom Febuksostat Mylan jemlje druga zdravila za njihovo preprečevanje.
English: This means that Febuxostat Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adenuric.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Adenuric, ki je že odobreno v Evropski uniji (EU).
English: As for every medicine, the company provided studies on the quality of Febuxostat Mylan.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Febuksostat Mylan.
English: When this happens in the joints and causes pain, it is known as ‘gout'.
Slovenian: Kadar pride do odlaganja v sklepih, ki povzroča bolečino, to imenujemo „protin“ ali „putika“.
English: For more information about treatment with Febuxostat Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Febuksostat Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Febuxostat Mylan 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 Febuksostat Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What are the benefits and risks of Febuxostat Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Febuksostat Mylan?
English: In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo, naj bi zmanjšanje ravni sečne kisline po pričakovanjih zmanjšalo tveganje za sindrom tumorske lize.
English: Febuxostat Mylan is available as tablets (80 and 120 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Febuksostat Mylan je na voljo v obliki tablet (80 in 120 mg), njegovo predpisovanje in izdaja je le na recept.
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day.
Slovenian: Za preprečevanje in zdravljenje hiperurikemije pri bolnikih, ki prejemajo kemoterapijo, je priporočeni odmerek 120 mg enkrat dnevno.
English: For practical information about using Febuxostat Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Febuksostat Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Keeping uric acid levels low for long enough can also shrink tophi.
Slovenian: Vzdrževanje koncentracije sečne kisline na nizki ravni dovolj dolgo lahko zmanjša tudi velikost tofov.
English: For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Mylan is 80 mg once a day.
Slovenian: Pri zdravljenju dolgotrajne hiperurikemije je priporočeni odmerek zdravila Febuksostat Mylan 80 mg enkrat na dan.
English: Febuxostat Mylan is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Slovenian: Zdravilo Febuksostat Mylan se uporablja pri bolnikih, ki kažejo znake odlaganja kristalov, vključno s protinskim artritisom (bolečino in vnetjem v sklepih) ali tofi („kamni“večjimi skupki kristalov urata, ki lahko povzročijo poškodbe sklepov in kosti).
English: Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
Slovenian: Hiperurikemija lahko privede do tvorbe kristalov urata in njihovega odlaganja v sklepih in ledvicah.
English: Febuxostat Mylan is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Slovenian: Zdravilo Febuksostat Mylan se uporablja tudi za zdravljenje in preprečevanje visokih ravni sečne kisline v krvi pri odraslih s krvnim rakom, ki prejemajo kemoterapijo (zdravila za zdravljenje raka) in so izpostavljeni tveganju za sindrom tumorske lize (zapletu zaradi razgradnje rakavih celic, ki povzroči nenadno povečanje sečne kisline v krvi, kar lahko privede do okvare ledvic).
English: What is Febuxostat Mylan and what is it used for?
Slovenian: Kaj je zdravilo Febuksostat Mylan in za kaj se uporablja?
English: Febuxostat Mylan contains the active substance febuxostat and is a ‘generic medicine'.
Slovenian: Zdravilo Febuksostat Mylan vsebuje zdravilno učinkovino febuksostat in je „generično zdravilo“.
English: By reducing the production of uric acid, Febuxostat Mylan can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Slovenian: Z zmanjševanjem tvorbe sečne kisline lahko zdravilo Febuksostat Mylan zniža njeno koncentracijo v krvi in jo vzdržuje na nizki ravni ter tako ustavi kopičenje kristalov.
English: Therefore, the CHMP's view was that, as for Adenuric, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Adenuric odtehtajo znana tveganja.
English: Febuxostat Mylan is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Slovenian: Zdravilo Febuksostat Mylan se uporablja za zdravljenje odraslih z dolgotrajno hiperurikemijo (visokimi koncentracijami sečne kisline ali urata v krvi).
English: Febuxostat Mylan febuxostat
Slovenian: Febuksostat Mylan febuksostat
English: It is not intended to provide practical advice on how to use Febuxostat Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Other information about Febuxostat Mylan
Slovenian: Druge informacije o zdravilu Febuksostat Mylan
English: Why is Febuxostat Mylan approved?
Slovenian: Zakaj je bilo zdravilo Febuksostat Mylan odobreno?
English: The active substance in Febuxostat Mylan, febuxostat, reduces the formation of uric acid.
Slovenian: Zdravilna učinkovina zdravila Febuksostat Mylan, febuksostat, zmanjša tvorjenje sečne kisline.
English: How is Febuxostat Mylan used?
Slovenian: Kako se zdravilo Febuksostat Mylan uporablja?
English: Febuxostat Mylan treatment should not be stopped if an attack of gout occurs.
Slovenian: V primeru zagona protina se zdravljenje z zdravilom Febuksostat Mylan ne sme prekiniti.
English: How does Febuxostat Mylan work?
Slovenian: Kako zdravilo Febuksostat Mylan deluje?
English: How has Febuxostat Mylan been studied?
Slovenian: Kako je bilo zdravilo Febuksostat Mylan raziskano?
English: The procedure should be carried out under sterile conditions.
Slovenian: Postopek je treba izvajati v sterilnih pogojih.
English: Jetrea ocriplasmin
Slovenian: Jetrea okriplazmin
English: What measures are being taken to ensure the safe and effective use of Jetrea?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jetrea?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jetrea on 13 March 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Jetrea, veljavno po vsej Evropski uniji, izdala 13. marca 2013.
English: The other eye should not be treated with Jetrea for at least 7 days.
Slovenian: Drugo oko se z zdravilom Jetrea ne sme zdraviti najmanj sedem dni.
English: The full EPAR for Jetrea 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 Jetrea je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Jetrea.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jetrea.
English: After 28 days, the results were that adhesions had cleared in 25% and 28% of patients who were given Jetrea injection (61 out of 219 and 62 out of 245), compared with 13% and 6% of those who received placebo (14 out of 107 and 5 out of 81).
Slovenian: Po 28 dneh so rezultati pokazali odpravo adhezije pri 25 % oziroma 28 % (61 od 219 oziroma 62 od 245) bolnikov, ki so prejeli injekcijo zdravila Jetrea, v primerjavi s 13 % oziroma 6 % (14 od 107 oziroma 5 od 81) bolnikov, ki so prejeli placebo.
English: What benefits of Jetrea have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Jetrea izkazalo v študijah?
English: What is Jetrea and what is it used for?
Slovenian: Kaj je zdravilo Jetrea in za kaj se uporablja?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Jetrea večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The recommended dose is 0.125 mg given as a single injection into the affected eye which should not be repeated.
Slovenian: Priporočeni odmerek je 0,125 mg, ki se daje z enkratnim injiciranjem v prizadeto oko in se ne sme ponoviti.
English: Other information about Jetrea
Slovenian: Druge informacije o zdravilu Jetrea
English: Although the effects shown were modest (resolution of vitreomacular adhesion in a quarter of patients), they were considered to be significant as treatment may improve vision and prevent the need for surgery.
Slovenian: Čeprav so bili učinki zdravila skromni (odprava vitreaomakularne adhezije pri četrtini bolnikov), so bili ocenjeni kot pomembni, saj lahko zdravljenje izboljša vid in odpravi potrebo po kirurškem posegu.
English: Regarding its safety, the most common side effects were short-lived and considered manageable, and often occurred as a response to the injection procedure or were linked to the resolution of the disease itself.
Slovenian: Kar zadeva varnost zdravila, so bili najpogostejši neželeni učinki kratkotrajni in ocenjeni kot obvladljivi ter so se pogosto pojavili kot odziv na injiciranje ali pa so bili povezani z odpravo same bolezni.
English: In two main studies involving 652 adults with vitreomacular adhesion and decreased vision, patients were given a single intravitreal injection of 0.125 mg Jetrea or a placebo injection (a dummy treatment).
Slovenian: V dveh glavnih študijah, ki sta vključevali 652 odraslih z vitreomakularno adhezijo in poslabšanim vidom, so bolniki prejeli eno intravitrealno injekcijo 0,125 mg zdravila Jetrea ali injekcijo placeba (zdravila brez zdravilne učinkovine).
English: What are the risks associated with Jetrea?
Slovenian: Kakšna tveganja so povezana z zdravilom Jetrea?
English: Why is Jetrea approved?
Slovenian: Zakaj je bilo zdravilo Jetrea odobreno?
English: Jetrea must not be used in patients who have or are thought to have infections in or around the eyes.
Slovenian: Zdravila Jetrea ne smejo uporabljati bolniki, ki imajo ali utegnejo imeti okužbo v očesu ali okoli njega.
English: It is not intended to provide practical advice on how to use Jetrea.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: It contains the active substance ocriplasmin.
Slovenian: Vsebuje zdravilno učinkovino okriplazmin.
English: The most common side effects are vitreous floaters (small, often irregular, dark shapes in the field of vision), eye pain, photopsia (flashes of light in the field of vision) and chromatopsia (changes in colour perception), as well as conjunctival haemorrhage (bleeding of the membrane that lies over the white part of the eye).
Slovenian: Najpogostejši neželeni učinki so delci v steklovini (majhne, temne pike, pogosto nepravilnih oblik, v vidnem polju), bolečina v očesu, fotopsija (utrinki svetlobe v vidnem polju) in kromatopsija (spremembe v zaznavanju barv) ter krvavitev v očesni veznici (krvavitev v membrani, ki prekriva beli del očesa).
English: Jetrea is a solution for injection into the eye.
Slovenian: Zdravilo Jetrea je raztopina za injiciranje v oko.
English: For more information about treatment with Jetrea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Jetrea preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jetrea have also 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 Jetrea upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The risk of more serious side effects such as decreased vision that is non-reversible, other changes to the retinal function or supporting structures of the lens appear to be small.
Slovenian: Tveganje za resnejše neželene učinke, kot so trajno poslabšanje vida, druge spremembe delovanja mrežnice ali podpornih struktur leče, je majhno.
English: For practical information about using Jetrea, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Jetrea naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive the summary of product characteristics for the medicine as well as an information pack to be given to patients.
Slovenian: Družba, ki trži zdravilo Jetrea, mora zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi to zdravilo uporabljali, prejeli povzetek glavnih značilnosti zdravila in informativno gradivo za bolnike.
English: The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision.
Slovenian: Zdravilna učinkovina zdravila Jetrea, okriplazmin, je podobna humanemu plazminu, tj. encimu, ki je naravno prisoten v očesu in ima sposobnost razgradnje beljakovin med steklovino in mrežnico, ki so odgovorne za adhezijo, s čimer zmanjšuje otekanje mrežnice in izboljšuje vid.
English: The side effects seen with Jetrea affect the eye.
Slovenian: Neželeni učinki, opaženi pri uporabi zdravila Jetrea, prizadenejo oko.
English: Vitreomacular traction is caused by vitreomacular adhesion in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye).
Slovenian: Vitreomakularno trakcijo povzroča vitreomakularna adhezija, pri kateri je steklovina nenormalno tesno vezana na osrednji del mrežnice (na svetlobo občutljive membrane v ozadju očesa).
English: Studies have shown that Jetrea was effective in treating vitreomacular adhesion and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive vitreomacular traction.
Slovenian: Študije so pokazale, da je bilo zdravilo Jetrea učinkovito pri zdravljenju vitreomakularne adhezije, zato naj bi bilo učinkovito tudi pri preprečevanju poslabšanja vida, do katerega lahko pride zaradi nezdravljene in napredovale vitreomakularne trakcije.
English: Successful treatment of vitreomacular adhesion can help reverse disturbances of the vision caused by vitreomacular traction, and prevent further loss of vision from untreated and progressive traction at the retina.
Slovenian: Uspešno zdravljenje vitreomakularne adhezije lahko pomaga odpraviti motnje vida zaradi vitreomakularne trakcije in preprečiti nadaljnjo izgubo vida zaradi nezdravljene in napredovale trakcije mrežnice.
English: The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections.
Slovenian: Oftalmolog lahko pred zdravljenjem z zdravilom Jetrea in po njem predpiše antibiotične kapljice za oko za preprečevanje očesnih okužb.
English: Jetrea is a medicine used to treat adults with vitreomacular traction, an eye disease that can cause severe visual disturbance.
Slovenian: Zdravilo Jetrea se uporablja za zdravljenje odraslih z vitreomakularno trakcijo, tj. očesno boleznijo, ki lahko povzroči hude motnje vida.
English: It can only be obtained with a prescription and must be given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye).
Slovenian: Predpisovanje in izdaja zdravila je le na recept, injicirati pa ga mora ustrezno usposobljeni oftalmolog (specialist za oči), ki ima izkušnje z dajanjem intravitrealnih injekcij (injiciranjem v steklovino, tj. želatini podobno tekočino v očesu).
English: Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery.
Slovenian: Zdravilo Jetrea se je med študijami izkazalo za učinkovito pri odpravi adhezije med steklovino in mrežnico, s čimer se je zmanjšala potreba po kirurškem posegu.
English: For the full list of all side effects reported with Jetrea, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Jetrea, glejte navodilo za uporabo.
English: When the vitreous humour shrinks with aging, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision.
Slovenian: Ko se steklovina z leti skrči, zaradi tesne vezave za seboj povleče tudi mrežnico, kar povzroči otekanje mrežnice in privede do zamegljenega ali popačenega vida.
English: How does Jetrea work?
Slovenian: Kako zdravilo Jetrea deluje?
English: How is Jetrea used?
Slovenian: Kako se zdravilo Jetrea uporablja?
English: Member State (in EEA)
Slovenian: Država članica (v EGP)
English: (Invented) Name Strength
Slovenian: (Izmišljeno) Ime Jakost
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: 4 mg/40 mg tablet
Slovenian: 4 mg/40 mg tableta peroralna uporaba
English: 0.10 g/1 g per 100 ml oral solution
Slovenian: 0.10 g/1 g na 100 ml peroralna raztopina peroralna uporaba
English: VASOBRAL, solution buvable en flacon
Slovenian: VASOBRAL, peroralna raztopina v viali
English: VASOBRAL, comprimé sécable
Slovenian: VASOBRAL, zarezo tableta
English: Marketing Authorisaton Holder
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: The Committee also noted that the last study performed in infants below one year was completed in 2001.
Slovenian: Prav tako je bil Odbor seznanjen, da je bila zadnja raziskava, opravljena na dojenčkih, mlajših od enega leta, zaključena leta 2001.
English: There is no evidence that either short or long term protection has been impacted.
Slovenian: Nikakršnih dokazov ni o vplivu na kratkoročno ali dolgoročno zaščito.
English: It was considered that a decision will be taken according to the responses given on quality and clinical concerns.
Slovenian: Sklenil je, da bo odločitev temeljila na odgovorih o kakovosti in kliničnih zadržkih.
English: These changes, in principle, address the concerns raised by the CHMP and its Working Parties.
Slovenian: Te spremembe se načeloma naslavljajo na zadržke, ki so se pojavili pri CHMP in njegovih delovnih skupinah.
English: In the past experience, there has never been an instance when high performance in adolescents and young adults did not correspond with high performance in infants.
Slovenian: V preteklih izkušnjah se še ni zgodilo, da bi velik učinek pri mladostnikih in mladih odraslih ne odgovarjal velikemu učinku pri dojenčkih.
English: Therefore, the results of this study provide evidence that the currently available product is providing the expected level of protective antibodies in all populations for which it is indicated.
Slovenian: Zato rezultati te raziskave dokazujejo, da daje trenutno razpoložljiv izdelek pričakovano raven zaščitnih protiteles v vseh populacijah, za katere je indiciran.
English: There are some indications that the Hep B vaccine currently produced is less immunogenic than the vaccine produced in the 1990's.
Slovenian: Nekaj indikacij kaže na to, da je cepivo Hep B, ki se trenutno izdeluje, manj imunogeno kot cepivo, izdelano v 90-ih letih prejšnjega stoletja.
English: Pending the outcome of the studies, the MAH committed to amend the SPC sections 4.2, 4.4, 4.5 (where relevant) and 5.1 as follows:
Slovenian: V pričakovanju izida raziskav se imetnik dovoljenja za promet zavezuje k dopolnitvi poglavij 4.2, 4.4, 4.5 (kjer je primerno) in 5.1 v SPC z naslednjim besedilom:
English: The CHMP endorsed the new product information and agreed to finalise the article 20 procedure without any further regulatory action.
Slovenian: CHMP je potrdil nove podatke o izdelku in sklenil brez nadaljnjih regulatornih ukrepov dokončati postopek iz člena 20.
English: Information will be provided to health care professionals and will ensure that the vaccine will be correctly used in the different age and risk categories.
Slovenian: Podatki bodo na voljo zdravnikom in bodo zagotavljali pravilno uporabo cepiva v različnih starostnih kategorijah in kategorijah tveganja.
English: The reason for decreasing immunogenicity over several years remains still unidentified.
Slovenian: Razlog za večletno padajočo imunogenost še ni znan.
English: These trials were carried out in different risk groups and age categories, i.e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age.
Slovenian: Preizkušanje so izvedli v različnih skupinah tveganja in starostnih kategorijah, npr. otrocih, rojenih hepatitis B pozitivnim materam, dojenčkih, zdravih mladih odraslih in zdravih osebah, starih od 16 do 35 let.