FrancophonIA/ELRC3.0 huggingface dataset:
English: The global symptom score also improved more in the patients taking Prometax.
Slovenian: Tudi rezultat celostne ocene simptomov je bil boljši pri bolnikih, ki so jemali zdravilo Prometax.
English: It is available as capsules (1.5, 3, 4.5 and 6 mg), as an oral solution (2 mg/ml), and as transdermal patches, which release either 4.6 , 9.5 or 13.3 mg rivastigmine across the skin over 24 hours.
Slovenian: Na voljo je v obliki kapsul (1,5 mg, 3 mg, 4,5 mg in 6 mg), kot peroralna raztopina (2 mg/ml) in transdermalni obliž, ki v 24 urah skozi kožo sprosti 4,6 mg, 9,5 mg ali 13,3 mg rivastigmina.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Slovenian: Rivastigmin deluje tako, da zavira encima, ki razgrajujeta acetilholin: acetilholinesterazo in butirilholinesterazo.
English: The company that makes Prometax must ensure that all doctors who intend to prescribe Prometax transdermal patch receive an information pack containing instructions to be given to patients and caregivers on how to use the patch safely as well as a reminder card for patients and caregivers that contains key information on how to use the patch and allows them to record the application and removal of patches.
Slovenian: Družba, ki proizvaja zdravilo Prometax mora zagotoviti, da vsi zdravniki, ki bodo predpisovali transdermalne obliže zdravila Prometax v odmerku 13,3 mg/24 ur, prejmejo informacijsko gradivo z navodili za varno uporabo obližev, ki jih je treba posredovati bolnikom in negovalcem, ter opozorilno kartico za bolnike in negovalce, ki vsebuje ključne informacije o načinu uporabe obližev in beležko za vodenje evidence o namestitvi in odstranitvi obližev.
English: The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Slovenian: Kapsule in peroralna raztopina se lahko uporabljajo tudi za zdravljenje blage do zmerno hude demence pri bolnikih s Parkinsonovo boleznijo.
English: Prometax was more effective than placebo at controlling symptoms.
Slovenian: Zdravilo Prometax je bilo pri obvladovanju simptomov učinkovitejše od placeba.
English: Prometax is a medicine containing the active substance rivastigmine.
Slovenian: Prometax je zdravilo, ki vsebuje zdravilno učinkovino rivastigmin.
English: The types of side effects seen with Prometax depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Slovenian: Vrste neželenih učinkov, opaženih pri zdravilu Prometax, so odvisne od vrste demence, ki se zdravi, in od tega, ali se uporabljajo kapsule, peroralna raztopina ali transdermalni obliži.
English: By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease.
Slovenian: Zdravilo Prometax z zaviranjem teh encimov omogoča, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi Alzheimerjeve demence in demence zaradi Parkinsonove bolezni ublažijo.
English: For the transdermal patch application site reactions are the most commonly seen side effects.
Slovenian: Pri uporabi transdermalnega obliža so najpogostejši neželeni učinki reakcije na mestu uporabe obliža.
English: Prometax has been studied in mild to moderately severe Alzheimer's disease.
Slovenian: Zdravilo Prometax so proučevali pri blagi do zmerno hudi Alzheimerjevi bolezni.
English: In the three studies of Prometax capsules in patients with Alzheimer's dementia, patients taking doses of Prometax between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Slovenian: V treh študijah zdravila Prometax pri bolnikih z Alzheimerjevo demenco je bilo pri tistih, ki so jemali od 6- do 9miligramske odmerke zdravila Prometax, opaziti povprečno povečanje kognitivnih simptomov za 0,2 točke od izhodiščne vrednosti 22,9 točke na začetku študije, pri čemer nižji rezultat pomeni boljšo učinkovitost.
English: What is the risk associated with Prometax?
Slovenian: Kakšna tveganja so povezana z zdravilom Prometax?
English: The patients with dementia due to Parkinson's disease taking Prometax capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Slovenian: Pri bolnikih z demenco zaradi Parkinsonove bolezni, ki so jemali kapsule zdravila Prometax, je bilo opaziti izboljšanje kognitivnih simptomov za 2,1 točke, v primerjavi s poslabšanjem za 0,7 točke pri tistih, ki so jemali placebo, od izhodiščne vrednosti približno 24 točk.
English: The active substance in Prometax, rivastigmine, is an antidementia medicine.
Slovenian: Zdravilna učinkovina zdravila Prometax, rivastigmin, je zdravilo za zdravljenje demence.
English: For the global score, patients taking Prometax capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Slovenian: Kar zadeva rezultat celostne ocene simptomov, je pri bolnikih, ki so jemali kapsule zdravila Prometax, prišlo do povečanja simptomov za 4,1 točke v primerjavi s 4,4 točke pri tistih, ki so jemali placebo.
English: Patients can be switched from the capsules or oral solution to the patches.
Slovenian: Bolniki lahko s kapsul ali peroralne raztopine preidejo na obliže.
English: Why has Prometax been approved?
Slovenian: Zakaj je bilo zdravilo Prometax odobreno?
English: For the full list of all side effects reported with Prometax, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prometax, glejte navodilo za uporabo.
English: See the summary of product characteristics (also part of the EPAR) for detailed information.
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: If the transdermal patches are used, the 4.6 mg per 24 hours patch should be used first, with the dose increased to the 9.5 mg/24 h patch after at least four weeks if the lower dose is well tolerated.
Slovenian: Če se uporabljajo transdermalni obliži, je treba najprej uporabiti obliž, ki v 24 urah sprosti 4,6 mg učinkovine, po najmanj štirih tednih pa je odmerek mogoče povečati na 9,5 mg v 24 urah, če bolnik nižji odmerek dobro prenaša.
English: The 9.5 mg/24 h patch should be used for as long as the patient benefits from it. After six months of treatment with 9.5 mg/24 hours, the doctor may increase the dose to 13.3 mg/24 hours if the patient's condition has worsened.
Slovenian: Po šestih mesecih zdravljenja z obližem, ki vsebuje odmerek 9,5 mg/24 ur, lahko zdravnik odmerke poviša na 13,3 mg/24 ur, če se bolnikovo stanje poslabša.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Slovenian: Pri bolnikih, ki prenašajo navedeni odmerek, se lahko ta postopoma povečuje za 1,5 mg, vendar ne pogosteje kot vsaka dva tedna, dokler se ne doseže stalni odmerek 3 do 6 mg dvakrat na dan. Za dosego največje učinkovitosti se uporabi največji odmerek, ki ga bolnik še prenaša, vendar ta ne sme preseči 6 mg dvakrat na dan.
English: How does Prometax work?
Slovenian: Kako zdravilo Prometax deluje?
English: How has Prometax been studied?
Slovenian: Kako je bilo zdravilo Prometax raziskano?
English: What is Prometax?
Slovenian: Kaj je zdravilo Prometax?
English: What is Prometax used for?
Slovenian: Za kaj se zdravilo Prometax uporablja?
English: How is Prometax used?
Slovenian: Kako se zdravilo Prometax uporablja?
English: After the starting dose, Amgevita is most often given every two weeks, but it may be given every week in certain situations.
Slovenian: Po začetnem odmerku se zdravilo Amgevita najpogosteje daje vsaka dva tedna, vendar pa se v nekaterih okoliščinah lahko daje vsak teden.
English: This means that Amgevita is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: What measures are being taken to ensure the safe and effective use of Amgevita?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Amgevita?
English: The full EPAR for Amgevita 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 Amgevita je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Amgevita.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: These packs will include information on the safety of the medicine and an alert card to be given to patients.
Slovenian: To bo vsebovalo informacije o varnosti zdravila in opozorilno kartico za bolnike.
English: Other information about Amgevita
Slovenian: Druge informacije o zdravilu Amgevita
English: This is a summary of the European public assessment report (EPAR) for Amgevita.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Amgevita.
English: What are the risks associated with Amgevita?
Slovenian: Kakšna tveganja so povezana z zdravilom Amgevita?
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Slovenian: Adalimumab z vezavo na TNF zavre njegovo delovanje in tako zmanjša vnetje in druge simptome bolezni.
English: After training, patients or their carers may inject Amgevita if their doctor considers it appropriate.
Slovenian: Bolniki ali njihovi skrbniki lahko po opravljenem usposabljanju sami injicirajo zdravilo Amgevita, če zdravnik meni, da je to zanje primerno.
English: The medicine is available as a solution for injection under the skin in a pre-filled syringe or pen.
Slovenian: Zdravilo je na voljo kot raztopina za injiciranje pod kožo v napolnjeni injekcijski brizgi ali peresniku.
English: Patients may be given other medicines during treatment with Amgevita, such as methotrexate or corticosteroids (other anti‑inflammatory medicines).
Slovenian: Bolnikom se med zdravljenjem z zdravilom Amgevita lahko dajejo tudi druga zdravila, kot so metotreksat ali kortikosteroidi (druga protivnetna zdravila).
English: Amgevita is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Slovenian: Zdravilo Amgevita se večinoma uporablja pri odraslih, katerih bolezen je huda, zmerno huda ali se poslabšuje oziroma kadar bolnik ne more prejemati drugega zdravljenja.
English: The company that markets Amgevita must provide educational packs for doctors who will prescribe the medicine.
Slovenian: Družba, ki trži zdravilo Amgevita, mora pripraviti izobraževalno gradivo za zdravnike, ki ga bodo predpisovali.
English: What benefits of Amgevita have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Amgevita izkazalo v študijah?
English: For detailed information on the use of Amgevita in all conditions, including when it can be used in children, see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o uporabi zdravila Amgevita pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: The reference medicine for Amgevita is Humira.
Slovenian: Referenčno zdravilo za zdravilo Amgevita je zdravilo Humira.
English: The dose depends on the condition to be treated and in children is usually calculated according to the child's weight and height.
Slovenian: Odmerek je odvisen od bolezni, ki se zdravi, pri otrocih pa se odmerek običajno izračuna na podlagi telesne mase in višine otroka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amgevita 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 Amgevita upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Amgevita is a medicine that acts on the immune system and is used to treat the following conditions:
Slovenian: Zdravilo Amgevita učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
English: Amgevita and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Slovenian: Zdravilo Amgevita in druga zdravila iz istega razreda lahko vplivajo tudi na obrambno sposobnost imunskega sistema proti okužbam in raku, saj so bili pri bolnikih, ki prejemajo adalimumab, zabeleženi nekateri primeri resnih okužb in krvnega raka.
English: In addition, studies in rheumatoid arthritis and psoriasis have shown that the effects of the medicine are equivalent to those of Humira in these conditions.
Slovenian: Poleg tega sta študiji pri revmatoidnem artritisu in psoriazi dokazali, da so učinki zdravila Amgevita pri teh boleznih enakovredni učinkom zdravila Humira.
English: Other rare serious side effects (seen in between 1 in 10,000 and 1 in 1,000 patients) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Slovenian: Drugi redki resni neželeni učinki (ki so se pojavili pri od 1 bolniku od 10 000 do 1 bolniku od 1 000) vključujejo nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podobna stanja (obolenja, pri katerem imunski sistem napada bolnikova lastna tkiva, kar povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (hudo kožno obolenje).
English: Amgevita can only be obtained with a prescription and treatment should be started and supervised by specialist doctors experienced in the diagnosis and treatment of the conditions for which it is authorised.
Slovenian: Predpisovanje in izdaja zdravila Amgevita je le na recept, zdravljenje z njim pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere je zdravilo odobreno.
English: Amgevita must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Slovenian: Zdravilo Amgevita se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
English: Why is Amgevita approved?
Slovenian: Zakaj je bilo zdravilo Amgevita odobreno?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Amgevita has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Amgevita po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Humira in da se po telesu enako prenaša.
English: The Committee recommended that Amgevita be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Amgevita izda dovoljenje za promet.
English: For more information about treatment with Amgevita, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Amgevita preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The active substance in Amgevita, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Slovenian: Zdravilna učinkovina zdravila Amgevita, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna kemični prenašalec, imenovan tumorje nekrotizirajoči faktor (TNF), in se veže nanj.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Slovenian: Najpogostejši neželeni učinki zdravila Amgevita (ki so se pojavili pri več kot 1 bolniku od 10) so okužbe nosu in grla, sinusov in zgornjih dihal, reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
English: Doctors treating uveitis should also take advice from doctors who have experience of using Amgevita.
Slovenian: Zdravniki, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Amgevita.
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Amgevita is used to treat.
Slovenian: Ta prenašalec sodeluje pri povzročanju vnetja in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, ki se zdravijo z zdravilom Amgevita.
English: What is Amgevita and what is it used for?
Slovenian: Kaj je zdravilo Amgevita in za kaj se uporablja?
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Slovenian: • neinfektivnega uveitisa (vnetja sloja pod beločnico očesa).
English: Because Amgevita is a biosimilar medicine, the studies on effectiveness and safety carried out for Humira do not all need to be repeated for Amgevita.
Slovenian: Zdravilo Amgevita je „podobno biološko zdravilo“, zato vseh študij o učinkovitosti in varnosti, izvedenih za zdravilo Humira, za zdravilo Amgevita ni treba ponavljati.
English: Therefore, the CHMP's view was that, as for Humira, the benefit outweighs the identified risk.
Slovenian: Zato je odbor CHMP menil, da njegove koristi enako kot pri zdravilu Humira odtehtajo znana tveganja.
English: All these data were considered sufficient to conclude that Amgevita will behave in the same way as Humira in terms of effectiveness and safety in its approved indications.
Slovenian: Vsi ti podatki so bili zato ocenjeni kot zadostni za zaključek, da se bo zdravilo Amgevita pri odobrenih indikacijah z vidika učinkovitosti vedlo enako kot zdravilo Humira.
English: Amgevita contains the active substance adalimumab and is a ‘biosimilar medicine'.
Slovenian: Zdravilo Amgevita vsebuje zdravilno učinkovino adalimumab in je „podobno biološko zdravilo“.
English: For practical information about using Amgevita, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Amgevita naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there is no damage on X-ray but clear signs of inflammation
Slovenian: • aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno z ankilozirajočim spondilitisom in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
English: The medicine has been shown to have similar effects to Humira in one main study involving 526 patients with moderate to severe rheumatoid arthritis that had not responded adequately to methotrexate, and in another main study in 350 patients with moderate to severe psoriasis.
Slovenian: V eni glavni študiji, ki je vključevala 526 bolnikov z zmernim do hudim revmatoidnim artritisom, ki se niso ustrezno odzvali na metotreksat, in v drugi glavni študiji s 350 bolniki z zmerno do hudo psoriazo so dokazali, da ima zdravilo Amgevita podobne učinke kot zdravilo Humira.
English: For information on the doses to be used for each condition and other information on the use of Amgevita, see the package leaflet.
Slovenian: Za več informacij o odmerjanju pri posameznih boleznih in druge podatke o uporabi zdravila Amgevita glejte navodilo za uporabo.
English: How is Amgevita used?
Slovenian: Kako se zdravilo Amgevita uporablja?
English: weeks, there was an 81% improvement in symptom score with Amgevita compared with an 83% improvement with Humira.
Slovenian: V študiji pri psoriazi, v kateri so preučevali stopnjo izboljšanja po 16 tednih, je bilo izboljšanje na lestvici simptomov pri zdravilu Amgevita 81-odstotno, pri zdravilu Humira pa 83-odstotno.
English: • Crohn's disease (a disease causing inflammation of the gut)
Slovenian: • Crohnove bolezni (bolezni, ki povzroča vnetje črevesa);
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints)
Slovenian: • poliartikularnega juvenilnega idiopatskega artritisa in aktivnega artritisa, povezanega z entezitisom
English: Extensive laboratory studies comparing Amgevita with Humira have shown that adalimumab in Amgevita is highly similar to adalimumab in Humira in terms of chemical structure, purity and biological activity.
Slovenian: Obsežne laboratorijske študije, v katerih so zdravilo Amgevita primerjali z zdravilom Humira, so pokazale, da je zdravilna učinkovina adalimumab v zdravilu Amgevita po zgradbi, čistosti in biološkem delovanju zelo podoben adalimumabu v zdravilu Humira.
English: For the full list of restrictions with Amgevita, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Amgevita glejte navodilo za uporabo.
English: In the rheumatoid arthritis study, response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 75% of those given Amgevita responded, compared with 72% of those given Humira.
Slovenian: V študiji revmatoidnega artritisa so po 24 tednih zdravljenja odziv opredelili kot vsaj 20-odstotno izboljšanje simptomov.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin)
Slovenian: • psoriaze v plakih (bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži);
English: • rheumatoid arthritis (a disease causing inflammation of the joints)
Slovenian: • revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov);
English: • hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses
Slovenian: • obolenja hidradenitis suppurativa (inverznih aken), tj. kroničnega obolenja kože, ki povzroča zatrdline, abscese (gnojne tvorbe) in kožne brazgotine;
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut)
Slovenian: • ulceroznega kolitisa (bolezni, ki povzroča vnetje in razjede v črevesni sluznici);
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)
Slovenian: • psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih zaplat na koži in vnetje sklepov);
English: The European Commission issued a decision on 6 March 2009.
Slovenian: Evropska komisija je odločbo izdala dne 6. marca 2009.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Slovenian: Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, o napotitvi na podlagi razhajajočih se odločitev, ki so jih sprejele države članice.