natgillin/translations-raw huggingface dataset:
Blood glucose decreased Blood lactate dehydrogenase increased Neutrophil count increased Respiratory rate increased
Preiskave zvišan krvni tlak zmanjšanje koncentracije glukoze v krvi zvišana vrednost laktatdehidrogenaze v krvi povečano število nevtrofilcev zvišana frekvenca dihanja
For cases in which there is uncertainty about the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to clarify the relationship of the PET radioactivity and the grey matter anatomy.
Kadar ima tolmač na voljo posnetek nedavne sočasne preiskave CT ali MR, naj v primeru negotovosti glede lokacije sive možganovine in roba med sivo in belo možganovino na posnetku PET pregleda kombiniran posnetek PET-CT oziroma PET-MR, da razjasni povezavo med radioaktivnostjo PET in anatomijo sive možganovine.
In the 68 patients, a blinded visual patient-level PET read by 5 blinded readers resulted in a majority read sensitivity of 86% (95% CI: 72% to 95%) and specificity 92% (95% CI: 74% to 99%).
Pri 68 bolnikih je bila opravljena preiskava PET, vizualno slepa za bolnike in 5 odčitovalcev, ki so jo interpretirali; občutljivost je bila 86 % (95 % IZ (interval zaupanja): 72 % do 95 %) in specifičnost 92 % (95 % IZ: 74 % do 99 %) pri večini odčitavanj slik.
VIZAMYL may cause transient dizziness or vertigo, which may affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo VIZAMYL lahko povzroči prehodno omotico ali vrtoglavico, ki lahko vpliva na vašo sposobnost vožnje in upravljanja s stroji.
Talk to your nuclear medicine doctor before you are given VIZAMYL if you: have kidney problems have liver problems are pregnant or think you may be pregnant are breast-feeding
Opozorila in previdnostni ukrepi Preden prejmete zdravilo VIZAMYL se posvetujte z zdravnikom, če: imate težave z ledvicami imate težave z jetri ste noseči ali menite, da ste noseči dojite
EXPIRY DATE EXP: {hh:mm} {Time Zone} on {dd-mm-yyyy}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {hh:mm} {časovni pas} dne {dd-mm-llll}
Table 2 Estimated radiation absorbed doses from intravenous injection of VIZAMYL (adults)
Preglednica 2 Ocenjen absorbiran odmerek sevanja zdravila VIZAMYL (odrasli) po intravenoznem injiciranju zdravila
VIZAMYL is supplied in 10-mL and 15-mL Type I glass vials with halobutyl rubber stoppers and aluminium seals.
Zdravilo VIZAMYL je na voljo v 10-mililitrskih in 15-mililitrskih vialah iz stekla tipa I z zamaški iz halobutilne gume, zapečatenimi z aluminijasto zaporko.
If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom nuklearne medicine, ki nadzira postopek.
VIZAMYL has not been studied in patients with significant renal or hepatic impairment.
Zdravila VIZAMYL niso preučevali pri bolnikih s signifikantno okvaro ledvic ali jeter.
At 180 minutes, 90% of the radioactivity was present in plasma in the form of polar metabolites.
180 minut po dajanju ostane v krvi manj kot 90 % injicirane radioaktivnosti v obliki polarnih presnovkov.
20 minutes post-injection, 75% of the radioactivity in plasma was present as polar metabolites.
20 minut po injiciranju ostane v krvi manj kot 75 % injicirane radioaktivnosti v obliki polarnih presnovkov.
Organ uptake Maximal flutemetamol (18F) brain uptake of approximately 7% of an injected dose occurs within two minutes of administration.
Privzemanje v organih Do največjega privzema flutemetamola (18F) v možganih, ki znaša približno 7 % injiciranega odmerka,
However, VIZAMYL may cause transient dizziness and vertigo.
Vendar lahko zdravilo VIZAMYL povzroči prehodno omotico in vrtoglavico.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GE Healthcare AS
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GE Healthcare AS
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x mL YYYY MBq at reference time
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT xx,x ml YYYY MBq na referenčni čas.
VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F).
Posnetke z uporabo zdravila VIZAMYL lahko interpretirajo le osebe, usposobljene za interpretacijo posnetkov PET s flutemetamolom (18F).
Of the 232 patients enrolled, 224 had at least one post-scan review by the independent committee and were included in the analysis.
Od 232 vključenih bolnikov je bila po slikanju pri 224
If you have any further questions, ask your nuclear medicine doctor who will supervise your procedure.
• Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
What VIZAMYL is and what it is used for What you need to know before VIZAMYL is used How VIZAMYL is used
Kaj je zdravilo VIZAMYL in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo VIZAMYL Kako uporabljati zdravilo VIZAMYL Možni neželeni učinki
Advanced Accelerator Applications, 47014 Meldola (FC), Italy Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, France Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Instituto Tecnológico PET, SA, 28040 Madrid, Spain Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italy Nucleis SA, 4000 Liège, Belgium
Advanced Accelerator Applications, 47014 Meldola (FC), Italija Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, Francija Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija Instituto Tecnológico PET, SA, 28040 Madrid, Španija Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Španija Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO), Italija Nucleis SA, 4000 Liège, Belgija
The activity per vial may range from 400 MBq to 4000 MBq or from 400 MBq to 6000 MBq at the reference date and time.
Aktivnost ene viale na referenčni datum in čas je lahko v razponu od 400 MBq do 4000 MBq ali od 400 MBq do 6000 MBq.
Iterative or filtered back projection reconstruction is recommended with a slice thickness of 2 to 4 mm, and an axial matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a postsmoothing filter may be applied with a full width half maximum (FWHM) of not more than 5 mm, the filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of the reconstructed image.
Priporočena je iterativna ali filtrirana povratna projekcija z debelino rezine 2 do 4 mm, velikostjo matrice 128 x 128 z velikostjo slikovnih pik približno 2 mm.
VIZAMYL is supplied in a 10-mL or 15-mL glass vial.
Zdravilo VIZAMYL je na voljo v 10 ml ali 15 ml stekleni viali.
A pivotal study in 68 end-of-life patients was aimed at establishing the diagnostic performance of flutemetamol (18F) to detect the cortical neuritic plaque density.
V klinični študiji, ki podpira vlogo za pridobitev dovoljenja za promet pri 68 bolnikih ob koncu življenja je bil namen določiti diagnostični učinek flutemetamola (18F) za določitev gostote nevritičnih leh.
To minimise radiation dose to the bladder, hydration before and after VIZAMYL administration should be encouraged in order to permit frequent voiding.
Da zmanjšate odmerek sevanja za sečni mehur, spodbujajte hidracijo, kar omogoča pogosto odvajanje urina pred in po odmerjanju zdravila VIZAMYL.
The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously
Priporočena aktivnost za odraslega je 185 MBq flutemetamola (18F), apliciranega intravensko (kot bolus v roku približno 40 sekund).
• Information on amyloid pathology in Alzheimer Disease; relevant information on VIZAMYL as an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of VIZAMYL use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of VIZAMYL.
• Podatke o patologiji amiloida pri Alzheimerjevi bolezni; relevantne podatke o zdravilu VIZAMYL, kot PET indikatorju za β-amiloid, vključno z odobreno indikacijo v skladu z
For each patient, the radiation exposure must be justified by the likely benefit.
Utemeljitev razmerja med koristmi in tveganjem pri posamezniku Pri vsakem bolniku morate izpostavljanje ionizirajočemu sevanju utemeljiti na osnovi verjetnih koristi.
Upper large intestine Bladder
Ščitnica zgornje debelo črevo mehur
There is no evidence of flutemetamol (18F) binding to soluble forms of
Ni dokazov, da se flutemetamol (18F) lahko veže s topnimi oblikami Abeta.
No carcinogenicity and reproductive toxicology studies have been performed with flutemetamol (18F).
Študije rakotvornosti in študije vpliva na sposobnost razmnoževanja s flutemetamolom (18F) niso bile opravljene.
VIZAMYL has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo VIZAMYL nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
This could be harmful for people with alcoholism and needs to be taken into account in pregnant or breast-feeding women and people with liver problems or epilepsy.
Na vsebnost alkohola (etanola) morajo biti pozorne nosečnice in doječe matere in bolniki z jetrnimi boleznimi ali epilepsijo.
Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medicinal products may alter VIZAMYL image results.
Študij farmakodinamskega medsebojnega delovanja z drugimi zdravili pri bolnikih za ugotovitev morebitnih vplivov na rezultate preiskave z uporabo zdravila VIZAMYL niso izvedli.
Advanced Accelerator Applications, 47014 Meldola (FC), Italy Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, France Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Instituto Tecnológico PET, SA, 28040 Madrid, Spain Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italy Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgium MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, Bautzner Landstraβe 400, 01328 Dresden, Germany
Advanced Accelerator Applications, 47014 Meldola (FC), Italija Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, Francija Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija Instituto Tecnológico PET, SA, 28040 Madrid, Španija Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Španija Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO), Italija Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgija MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finska ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italija Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, Bautzner Landstraβe 400, 01328 Dresden, Nemčija
Reproductive system and breast disorders
Motnje reprodukcije in dojk motnje erekcije
Table 1 List of adverse reactions System Organ Class
Preglednica 1 Seznam neželenih učinkov
Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Z dojenjem nadaljujte v dogovoru z zdravnikom nuklearne medicine, ki nadzira postopek.
Withdrawals should be performed under aseptic conditions.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Odvzeme je treba opravljati v aseptičnih pogojih.
What VIZAMYL contains The active substance is flutemetamol (18F).
Kaj vsebuje zdravilo VIZAMYL Učinkovina je flutemetamol (18F).
A recent co-registered Computed Tomography (CT) scan or Magnetic Resonance (MR) scan of the patient to obtain a fused PET-CT or PET-MR image is recommended in cases of uncertainty about the location of grey matter and of the grey/white matter border in the PET scan (see section 4.4 Interpretation of VIZAMYL images).
V primeru negotovosti glede lokacije sive možganovine in meje med sivo in sivo/belo možganovino na posnetku PET se priporoča tudi pregled bolnikovih nedavnih posnetkov sočasne preiskave z računalniško tomografijo (CT) ali magnetno resonanco (MR) bolnika za dosego kombiniranega PET-CT ali PET-MR posnetka (glejte poglavje 4.4.
Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time.
En ml raztopine vsebuje 400 MBq flutemetamola (18F) na referenčni datum in čas.
VIZAMYL is a radioactive medicinal product that emits positrons, which annihilate with electrons to produce gamma rays, and must be handled with safety measures to minimise radiation exposure to clinical personnel and patients.
VIZAMYL je radioaktivno zdravilo, ki oddaja pozitrone, ti pa se izničijo z elektroni in pri tem ustvarjajo gama žarke.
Flutemetamol (18F) is excreted largely through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure.
Flutemetamol (18F) se v veliki meri izloči skozi hepatobiliarni sistem,
falling to 10 % at 180 minutes.
pride v dveh minutah po odmerjanju.
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.
V dveh podobnih študijah biološke porazdelitve in v klinični študiji II.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja hiperventilacija draženje grla
Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
Po postopku V prvih 24 urah po injiciranju je treba omejiti neposreden stik z dojenčki in nosečnicami.
Close contact with infants should be restricted during the initial 24 hours following injection.
Prvih 24 urah po injiciranju je treba omejiti bližnje stike z dojenčki.
Clear, colourless to slightly yellow solution.
FARMACEVTSKA OBLIKA raztopina za injiciranje Bistra, brezbarvna do rahlo rumena raztopina.
can detect β-amyloid diffuse plaques when they are frequent.
In vivo lahko s flutemetamolom (18F) odkrijemo difuzne lehe, ko so te pogoste.
Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dodecahydrate Water for injections
6.1 Seznam pomožnih snovi natrijev klorid brezvodni etanol polisorbat 80 natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dodekahidrat voda za injekcije
How VIZAMYL will be used
Kako uporabljati zdravilo VIZAMYL
Multidose vial
Velikost pakiranja
You may experience the following uncommon side effects: headache feeling dizzy feeling anxious feeling sick (nausea) chest discomfort low blood sugar (symptoms: hunger, headache)
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,
The effective dose is approximately 5.9 mSv when the maximal recommended activity of 185 MBq of flutemetamol (18F) is administered.
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL / 10 mL
NALEPKA NA ZAŠČITI / 10 mL
Dose
Priželjc
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKEDOVOLJENJ ZA PROMET
No in vivo interaction studies have been performed.
Študij medsebojnega delovanja z drugimi zdravili in vivo niso izvedli.
Lower large intestine wall Lungs
Koža tanko črevo
Muscle tightness Musculoskeletal pain
Bolezni mišično - skeletnega sistema in vezivnega tkiva bolečine v hrbtu napetost mišic mišičnoskeletna bolečina
VIZAMYL contains the active substance flutemetamol (18F) )and is used to help diagnose Alzheimer's disease and other causes of memory loss.
Zdravilo VIZAMYL vsebuje učinkovino flutemetamol (18F) in se uporablja za diagnosticiranje
Psychiatric disorders
Psihiatrične motnje aksioznost
Immune system disorders
Bolezni imunskega sistema anafilaktoidna reakcija
Anaphylactoid reaction
Žilne bolezni pordevanje
You should avoid any close contact with young children and pregnant women for 24 hours following the injection.
Po odmerjanju zdravila VIZAMYL 24 ur po injiciranju se izogibajte neposrednemu stiku z majhnimi otroki in nosečnicami.
Gallbladder
Bledica
Stomach
Vranica želodec
Feeling abnormal Feeling cold Infusion site pain Oedema
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
Renal /Hepatic impairment
Okvara ledvic/okvara jeter
Interpretation of VIZAMYL images
Interpretacija posnetkov z uporabo zdravila VIZAMYL).
Posology
Slikanje
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%).
Občutljivost je bila 92 % (95 % IZ: 83 % do 97 %) ter specifičnost 88 % (95 % IZ: 71,0 % do 97%).
The recommended dose is 300 micrograms per kilogram body weight once every 3 weeks.
Priporočeni odmerek je 300 mg na kilogram telesne mase enkrat na tri tedne.
What measures are being taken to ensure the safe and effective use of Onpattro?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Onpattro?
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.
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.
What benefits of Onpattro have been shown in studies?
Kakšne koristi zdravila Onpattro so se pokazale v študijah?
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.
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.
Further information on Onpattro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Onpattro so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Regarding safety, the most serious side effects are infusion-related reactions and these can be managed with premedication and changes to infusion speed.
Kar zadeva varnost, so najresnejši neželeni učinki reakcije, povezane z infuzijo, ki jih je mogoče obvladati s premedikacijo in spremembo hitrosti infundiranja.
As for all medicines, data on the use of Onpattro are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Onpattro stalno spremljajo.
Onpattro may be given at home by a healthcare professional if the patient has had at least 3 infusions given in hospital without problems.
Zdravilo Onpattro lahko zdravstveni delavec daje v domačem okolju, če je bolnik pred tem prejel vsaj tri infuzije v bolnišnici in ni imel težav.
Why is Onpattro authorised in the EU?
Zakaj je bilo zdravilo Onpattro odobreno v EU?
Other information about Onpattro
Druge informacije o zdravilu Onpattro
What are the risks associated with Onpattro?
Kakšna tveganja so povezana z zdravilom Onpattro?
An overview of Onpattro and why it is authorised in the EU
Pregled zdravila Onpattro in zakaj je odobreno v EU
Side effects reported with Onpattro are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Onpattro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
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.
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.
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.
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.
Patients should also take vitamin A supplements during treatment with Onpattro.
Bolniki morajo med zdravljenjem z zdravilom Onpattro jemati tudi dodatke vitamina A.
What is Onpattro and what is it used for?
Kaj je zdravilo Onpattro in za kaj se uporablja?
The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Razgrajena beljakovina tvori amiloidne skupke v tkivih in organih po vsem telesu, tudi okoli živcev, v katerih moti njihovo normalno delovanje.
Onpattro contains the active substance patisiran.
Zdravilo Onpattro vsebuje učinkovino patisiran.
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).
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).
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.
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.
For more information about using Onpattro, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Onpattro glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The medicine is available as a solution for infusion (drip) into a vein.
Zdravilo je na voljo v obliki raztopine za infundiranje (kapalne infuzije) v veno.
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.
Predpisovanje in izdaja zdravila Onpattro je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z amiloidozo.
This reduces production of defective transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Tako se zmanjša tvorba transtiretina, kar zmanjša nastajanje amiloidov in olajša simptome dedne transtiretinske amiloidoze.