FrancophonIA/ELRC3.0 huggingface dataset:
English: Flutemetamol (18F) is excreted largely through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure.
Slovenian: Flutemetamol (18F) se v veliki meri izloči skozi hepatobiliarni sistem,
English: falling to 10 % at 180 minutes.
Slovenian: pride v dveh minutah po odmerjanju.
English: In two similar studies of biodistribution and a phase II clinical study, mean quantitative uptake values in PET images differed between pAD and HV subjects in most examined areas of the brain.
Slovenian: V dveh podobnih študijah biološke porazdelitve in v klinični študiji II.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja hiperventilacija draženje grla
English: Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
Slovenian: Po postopku V prvih 24 urah po injiciranju je treba omejiti neposreden stik z dojenčki in nosečnicami.
English: Close contact with infants should be restricted during the initial 24 hours following injection.
Slovenian: Prvih 24 urah po injiciranju je treba omejiti bližnje stike z dojenčki.
English: Clear, colourless to slightly yellow solution.
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje Bistra, brezbarvna do rahlo rumena raztopina.
English: can detect β-amyloid diffuse plaques when they are frequent.
Slovenian: In vivo lahko s flutemetamolom (18F) odkrijemo difuzne lehe, ko so te pogoste.
English: Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dodecahydrate Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid brezvodni etanol polisorbat 80 natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dodekahidrat voda za injekcije
English: How VIZAMYL will be used
Slovenian: Kako uporabljati zdravilo VIZAMYL
English: Multidose vial
Slovenian: Velikost pakiranja
English: You may experience the following uncommon side effects: headache feeling dizzy feeling anxious feeling sick (nausea) chest discomfort low blood sugar (symptoms: hunger, headache)
Slovenian: Občasni - pojavijo se lahko pri največ 1 od 100 bolnikov Izkusite lahko naslednje občasne neželene učinke: glavobol, omotica, občutek tesnobe, siljenje na bruhanje (navzea), nelagodje v prsnem košu, majhna koncentracija sladkorja v krvi (simptom: potenje), bolečine v hrbtu, občutek vročine ali mraza, hitrejše dihanje, bolečina na mestu injiciranja,
English: The effective dose is approximately 5.9 mSv when the maximal recommended activity of 185 MBq of flutemetamol (18F) is administered.
Slovenian: Ker pri odmerjanju največje priporočene aktivnosti 185 MBq flutemetamola (18F) znaša učinkovit odmerek približno 5,92 mSv, je možnost za pojav teh neželenih učinkov izjemno majhna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL / 10 mL
Slovenian: NALEPKA NA ZAŠČITI / 10 mL
English: Dose
Slovenian: Priželjc
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKEDOVOLJENJ ZA PROMET
English: No in vivo interaction studies have been performed.
Slovenian: Študij medsebojnega delovanja z drugimi zdravili in vivo niso izvedli.
English: Lower large intestine wall Lungs
Slovenian: Koža tanko črevo
English: Muscle tightness Musculoskeletal pain
Slovenian: Bolezni mišično - skeletnega sistema in vezivnega tkiva bolečine v hrbtu napetost mišic mišičnoskeletna bolečina
English: VIZAMYL contains the active substance flutemetamol (18F) )and is used to help diagnose Alzheimer's disease and other causes of memory loss.
Slovenian: Zdravilo VIZAMYL vsebuje učinkovino flutemetamol (18F) in se uporablja za diagnosticiranje
English: Psychiatric disorders
Slovenian: Psihiatrične motnje aksioznost
English: Immune system disorders
Slovenian: Bolezni imunskega sistema anafilaktoidna reakcija
English: Anaphylactoid reaction
Slovenian: Žilne bolezni pordevanje
English: You should avoid any close contact with young children and pregnant women for 24 hours following the injection.
Slovenian: Po odmerjanju zdravila VIZAMYL 24 ur po injiciranju se izogibajte neposrednemu stiku z majhnimi otroki in nosečnicami.
English: Gallbladder
Slovenian: Bledica
English: Stomach
Slovenian: Vranica želodec
English: Feeling abnormal Feeling cold Infusion site pain Oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečine v prsnem košu občutek vročine astenija utrujenost nenormalno počutje občutek mraza bolečine na mesti infuzije edem pireksija
English: Renal /Hepatic impairment
Slovenian: Okvara ledvic/okvara jeter
English: Interpretation of VIZAMYL images
Slovenian: Interpretacija posnetkov z uporabo zdravila VIZAMYL).
English: Posology
Slovenian: Slikanje
English: In a secondary analysis that used a standard of truth based on the region of maximum neuritic plaque involvement in the 3 neocortical regions originally recommended by CERAD, sensitivity was 92% (95% CI: 83% to 97%), and specificity was 88% (95% CI: 71% to 97%).
Slovenian: Občutljivost je bila 92 % (95 % IZ: 83 % do 97 %) ter specifičnost 88 % (95 % IZ: 71,0 % do 97%).
English: The recommended dose is 300 micrograms per kilogram body weight once every 3 weeks.
Slovenian: Priporočeni odmerek je 300 mg na kilogram telesne mase enkrat na tri tedne.
English: What measures are being taken to ensure the safe and effective use of Onpattro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Onpattro?
English: The European Medicines Agency therefore decided that Onpattro'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 Onpattro večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What benefits of Onpattro have been shown in studies?
Slovenian: Kakšne koristi zdravila Onpattro so se pokazale v študijah?
English: The most common side effects with Onpattro (which may affect more than 1 in 10 people) are peripheral oedema (swelling, especially of the ankles and feet) and infusion-related reactions including pain, nausea (feeling sick), headache, tiredness, dizziness, cough and breathing problems, reddening of the skin, rapid heartbeat, low or high blood pressure and swelling of the face.
Slovenian: Najpogostejši neželeni učinki zdravila Onpattro (ki se lahko pojavijo pri več kot 1 bolniku od 10) so periferni edem (otekanje, zlasti gležnjev in stopal) in reakcije, povezane z infuzijo, vključno z bolečino, navzeja (slabost), glavobol, utrujenost, omotica, kašelj in težave z dihanjem, pordelost kože, hiter srčni utrip, nizek ali visok krvni tlak ter otekanje obraza.
English: Further information on Onpattro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Onpattro so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Regarding safety, the most serious side effects are infusion-related reactions and these can be managed with premedication and changes to infusion speed.
Slovenian: Kar zadeva varnost, so najresnejši neželeni učinki reakcije, povezane z infuzijo, ki jih je mogoče obvladati s premedikacijo in spremembo hitrosti infundiranja.
English: As for all medicines, data on the use of Onpattro are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Onpattro stalno spremljajo.
English: Onpattro may be given at home by a healthcare professional if the patient has had at least 3 infusions given in hospital without problems.
Slovenian: Zdravilo Onpattro lahko zdravstveni delavec daje v domačem okolju, če je bolnik pred tem prejel vsaj tri infuzije v bolnišnici in ni imel težav.
English: Why is Onpattro authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Onpattro odobreno v EU?
English: Other information about Onpattro
Slovenian: Druge informacije o zdravilu Onpattro
English: What are the risks associated with Onpattro?
Slovenian: Kakšna tveganja so povezana z zdravilom Onpattro?
English: An overview of Onpattro and why it is authorised in the EU
Slovenian: Pregled zdravila Onpattro in zakaj je odobreno v EU
English: Side effects reported with Onpattro are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Onpattro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The company that markets Onpattro will provide educational materials for doctors and patients with information about how to give the medicine safely when at home and how to manage side effects.
Slovenian: Podjetje, ki trži zdravilo Onpattro, bo za zdravnike in bolnike pripravilo izobraževalno gradivo z informacijami o tem, kako varno dajati zdravilo v domačem okolju in kako obvladovati neželene učinke.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onpattro 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 Onpattro upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Patients should also take vitamin A supplements during treatment with Onpattro.
Slovenian: Bolniki morajo med zdravljenjem z zdravilom Onpattro jemati tudi dodatke vitamina A.
English: What is Onpattro and what is it used for?
Slovenian: Kaj je zdravilo Onpattro in za kaj se uporablja?
English: The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Slovenian: Razgrajena beljakovina tvori amiloidne skupke v tkivih in organih po vsem telesu, tudi okoli živcev, v katerih moti njihovo normalno delovanje.
English: Onpattro contains the active substance patisiran.
Slovenian: Zdravilo Onpattro vsebuje učinkovino patisiran.
English: Onpattro is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).
Slovenian: Zdravilo Onpattro se uporablja pri odraslih bolnikih pri prvih dveh stopnjah poškodbe živcev (pri 1. stopnji, pri kateri bolnik lahko hodi brez pomoči, in 2. stopnji, pri kateri bolnik še lahko hodi, vendar potrebuje pomoč).
English: After 18 months of treatment, the mNIS+7 score decreased on average by 6 points with Onpattro (from around 81 to around 75 points), indicating a slight improvement of the patients' condition.
Slovenian: Po 18 mesecih zdravljenja se je rezultat mNIS+7 pri zdravilu Onpattro povprečno znižal za 6 točk (s približno 81 točk na približno 75 točk), kar kaže na majhno izboljšanje stanja bolnikov.
English: For more information about using Onpattro, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Onpattro glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The medicine is available as a solution for infusion (drip) into a vein.
Slovenian: Zdravilo je na voljo v obliki raztopine za infundiranje (kapalne infuzije) v veno.
English: Onpattro can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of patients with amyloidosis.
Slovenian: Predpisovanje in izdaja zdravila Onpattro je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z amiloidozo.
English: This reduces production of defective transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Slovenian: Tako se zmanjša tvorba transtiretina, kar zmanjša nastajanje amiloidov in olajša simptome dedne transtiretinske amiloidoze.
English: The main measure of effectiveness was the change in the patients' nerve damage, as measured using a standard scale called ‘mNIS+7', with scores ranging from 0 to 304 (a higher score indicates more severe nerve damage).
Slovenian: Glavno merilo učinkovitosti je bila sprememba poškodbe živcev pri bolnikih, izmerjena s standardno lestvico, imenovano „mNIS+7“, pri čemer je rezultat v razponu od 0 do 304 (višji rezultat pomeni hujšo poškodbo živcev).
English: The active substance in Onpattro, patisiran, is a ‘small interfering RNA' (siRNA), a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Slovenian: Učinkovina zdravila Onpattro, patisiran, je „majhna interferenčna RNK“, tj. zelo kratek košček umetnega genetskega materiala, ki je bil zasnovan tako, da se pritrdi na genetski material celice, odgovorne za tvorbo transtiretina, in ga zavira.
English: hATTR amyloidosis is rare, and Onpattro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Slovenian: Dedna transtiretinska amiloidoza je redka bolezen, zato je bilo zdravilo Onpattro 15. aprila 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: To reduce the risk of infusion-related reactions, patients should be given corticosteroid medicines, paracetamol and medicines known as H1 and H2 blockers before receiving Onpattro.
Slovenian: Preden bolniki prejmejo zdravilo Onpattro, morajo za zmanjšanje tveganja za reakcije, povezane z infuzijo, prejeti kortikosteroide, paracetamol in zdravila, znana kot zaviralci H1 in H2.
English: For the full list of side effects and restrictions with Onpattro, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Onpattro glejte navodilo za uporabo.
English: This compares with an increase on average by 28 points with placebo (from around 75 to around 101 points), indicating that nerve damage got worse in these patients.
Slovenian: Pri placebu je prišlo do zvišanja rezultata za približno 28 točk (s približno 75 točk na približno 101 točko), kar kaže, da se je poškodba živcev pri teh bolnikih poslabšala.
English: In patients with hATTR amyloidosis, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Slovenian: Pri bolnikih z dedno transtiretinsko amiloidozo je beljakovina transtiretin v krvnem obtoku okvarjena in se hitro razgradi.
English: In one main study involving 225 hATTR amyloidosis patients with stage 1 or 2 nerve damage, Onpattro was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
Slovenian: V eni glavni študiji, ki je vključevala 225 bolnikov z dedno transtiretinsko amiloidozo s 1. ali 2. stopnjo poškodbe živcev, so dokazali, da je zdravilo Onpattro pri upočasnitvi poškodbe živcev, ki jo povzroča bolezen, učinkovitejše od placeba (zdravila brez učinkovine).
English: Onpattro is a medicine used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
Slovenian: Zdravilo Onpattro se uporablja za zdravljenje poškodbe živcev, ki jo povzroča dedna transtiretinska amiloidoza, tj. bolezen, pri kateri se beljakovine, imenovane amiloidi, kopičijo v tkivih po telesu, tudi okoli živcev.
English: How is Onpattro used?
Slovenian: Kako se zdravilo Onpattro uporablja?
English: How does Onpattro work?
Slovenian: Kako zdravilo Onpattro deluje?
English: Onpattro was shown to be effective at slowing down nerve damage in hATTR amyloidosis patients with stage 1 or stage 2 nerve damage; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Slovenian: Zdravilo Onpattro se je izkazalo za učinkovito pri zdravljenju 1. ali 2. stopnje poškodbe živcev pri bolnikih z dedno transtiretinsko amiloidozo; razpoložljivi podatki ne zadoščajo za izpeljavo predpostavke o koristih zdravila pri bolnikih s 3. stopnjo poškodbe (ki so na invalidskem vozičku).
English: − If you are older than 70 years
Slovenian: − če ste starejši od 70 let
English: This is one of the most common causes of heart disease.
Slovenian: To je eden najpogostejših razlogov za bolezni srca.
English: − If you regularly drink a large amount of alcohol
Slovenian: − če redno uživate večje količine alkohola
English: Common: allergic reactions.
Slovenian: Pogosto: alergijske reakcije.
English: The following side effects are important and will require immediate action if you experience them:
Slovenian: Naslednji neželeni učinki so pomembni in v primeru, da jih izkusite, bo potrebno takojšnje ukrepanje:
English: Indeed, many of the patients were at low risk, particularly the females in ASCOT-LLA.
Slovenian: Seveda je v resnici imelo veliko bolnikov majhno tveganje, zlasti ženske v raziskavi ASCOT-LLA.
English: Increases and decreases in blood sugar levels have also been seen (If you have diabetes you should continue careful monitoring of your blood sugar levels).
Slovenian: Opazili so tudi upadanje in naraščanje ravni sladkorja v krvi (Če imate diabetes, morate še naprej skrbno spremljati raven sladkorja v krvi).
English: The CHMP recommended the granting of the type II variation to extend the indication.
Slovenian: CHMP priporoča odobritev variacije tipa II, da se razširi indikacija.
English: At the December plenary meeting, the CHMP adopted a LoQ centred on the following points:
Slovenian: Na decembrskem plenarnem zasedanju je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel seznam vprašanj (LoQ), ki se osredotoča na naslednje točke:
English: - The posology in Section 4.2 has been revised as follows:
Slovenian: - Odmerjanje v poglavju 4.2 je bilo popravljeno na naslednji način:
English: Finally, there has been much discussion regarding the wording of the indication that best reflects the results of the of the assessed trials.
Slovenian: Na koncu je bilo veliko razpravljanja o besedilu indikacije, ki najbolje odraža rezultate pregledanih preskušanj.
English: He/she will decide on the further steps needed.
Slovenian: Ta bo odločil o nadaljnjem ravnanju.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Sealed for your protection.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zalepljeno za vašo varnost.
English: Cholesterol is a naturally occurring substance in the body necessary for normal growth.
Slovenian: Holesterol je snov, ki je normalno prisotna v telesu in je potrebna za normalno rast.
English: • no untoward safety findings related to the extension of the indication have been identified.
Slovenian: • Ni bilo opaženih nobenih neželenih varnostnih ugotovitev v zvezi z razširitvijo indikacije,
English: Atorvastatin was not carcinogenic in rats.
Slovenian: Atorvastatin za podgane ni bil karcinogen.
English: • the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for atorvastatin (Sortis and associated names - see Annex I),
Slovenian: • je CHMP upošteval napotitev, podano po členu 6.12 Uredbe Komisije (ES) št. 1084/2003 za atorvastatin (zdravilo Sortis in povezana imena - glejte Dodatek I),
English: In a compassionate-use study of 64 patients there were 46 patients for whom confirmed LDL receptor information was available.
Slovenian: V raziskavi sočutne uporabe pri 64 bolnikih so bili za 46 bolnikov na voljo podatki o potrjenih receptorjih LDL.
English: The safety profile of atorvastatin in the MIRACL study was consistent with what is described in Section 4.8.
Slovenian: Varnostni profil atorvastatina je bil v študiji MIRACL skladen z navedbami v poglavju 4.8.
English: In order to get the same absolute efficacy of atorvastatin in both sexes, it is therefore necessary to treat women who have the same absolute risk as men, i.e. women with more additional risk factors, such as higher age, menopause, etc.
Slovenian: Da bi dobili enako absolutno učinkovitost atorvastatina pri obeh spolih, je treba zdraviti ženske, ki imajo enako absolutno tveganje kot moški, tj. ženske z več dodatnimi dejavniki tveganja, kot so višja starost, menopavza itd.
English: Dosage in patients with renal insufficiency
Slovenian: Odmerjanje pri bolnikih z ledvično insuficienco
English: Sortis and associated names contain atorvastatin, a well-known HMG-CoA reductase inhibitor (statin), registered in the EU since 1996 through Mutual Recognition Procedure and national procedures.
Slovenian: Sortis in povezana imena vsebujejo atorvastatin, splošno znani zaviralec reduktaze HMG-CoA (statin), ki je v EU registriran od leta 1996 po postopku medsebojnega priznavanja in nacionalnih postopkih.
English: - Section 5.1 has been updated to include the results of the ASCOT-LLA and CARDS trials as follows:
Slovenian: - Poglavje 5.1 je bilo posodobljeno z vključitvijo rezultatov preskušanj ASCOT-LLA in CARDS z naslednjim besedilom:
English: Overall conclusion on benefit/risk
Slovenian: Skupni zaključek o razmerju med koristmi in tveganji
English: • the CHMP, as a consequence, considered the benefit/risk balance for the above-mentioned extension of indication to be favourable,
Slovenian: • zato je CHMP mnenja, da je razmerje med koristmi in tveganji za zgoraj omenjeno razširitev indikacije ugodno.
English: Efficacy and safety in patients older than 70 using recommended doses is similar to that seen in the general population.
Slovenian: Pri bolnikih, starejših od 70 let, sta učinkovitost in varnost zdravila v priporočenih odmerkih podobna kot pri splošni populaciji.
English: Moreover, the Applicant has provided an adequate and objective justification against a restriction to exclude women from the proposed indication given the current knowledge regarding the beneficial effects of statin treatment overall and also in women, including trial results, guidelines and international recommendations.
Slovenian: Poleg tega je vlagatelj predložil zadostno in objektivno utemeljitev proti omejitvi, ki izključuje ženske iz predlagane indikacije, na podlagi trenutnega znanja o koristnih učinkih statinov na splošno in istočasno tudi pri ženskah, vključno z rezultati preskušanj, smernicami in mednarodnimi priporočili.
English: Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of {PRODUCT}.
Slovenian: Na dan ne spijte več kot en ali dva majhna kozarca grenivkinega soka, saj lahko le-ta v velikih količinah spremeni učinek {(Lastniško) ime}.
English: The CHMP agrees that there is no reason to believe that higher doses would have a lower effect than the 10mg dose in the approved indication, independently of individual target cholesterol levels, and the potentially different safety profile of higher dosages.
Slovenian: CHMP se strinja, da ni razlogov za mnenje, da bi imeli večji odmerki manjši učinek za odobreno indikacijo kot 10 mg odmerek, neodvisno od ciljnih ravni holesterola in potencialno drugačnega varnostnega profila večjih odmerkov.
English: Total coronary events
Slovenian: Skupno število koronarnih dogodkov
English: It is accepted that raised cholesterol levels increase the risk of heart disease.
Slovenian: Znano je, da zvišana raven holesterola povečuje tveganje za bolezni srca.
English: An overview of the approved indications for atorvastatin based on the ASCOT-LLA and CARDS studies across the EU.
Slovenian: Pregled odobrenih indikacij za atorvastatin, ki temeljijo na preskušanjih ASCOT-LLA in CARDS po vsej EU.
English: Liver function tests should be performed and serum CPK levels should be monitored.
Slovenian: Narediti je treba laboratorijske preiskave jetrne funkcije in nadzorovati raven CPK v serumu.
English: This wording was based on the results of 2 randomised controlled trials performed with atorvastatin 10 mg for the primary prevention of cardiovascular disease (CVD).
Slovenian: Besedilo je temeljilo na rezultatih 2 randomiziranih kontroliranih preskušanj, ki sta bili opravljeni z atorvastatinom 10 mg za primarno preprečevanje srčno-žilne bolezni (CVD).