natgillin/translations-raw huggingface dataset:
The images should be viewed in a systematic manner (Figure 1) starting at the level of pons (p) and scrolling up through The frontal lobes and anterior cingulate (f, ac, axial review) Posterior cingulate and precuneus (pc, sagittal review) Temporo-parietal aspects including Insula (in, axial review and tp-in, coronal review) Lateral temporal lobes (lt, axial review) Striatal region (s, axial review)
Snimke je potrebno pregledavati sistematično (Slika 1) počevši od razine mosta (p) prema gore kroz Frontalne režnjeve i prednji cingulatni korteks (f, ac, aksijalni prikaz) Stražnji cingulatni korteks i prekuneus (pc, sagitalni prikaz) Temporo-parijetalne dijelove uključujući inzulu (in, aksijalni prikaz i tp-in, koronalni prikaz) Lateralne temporalne režnjeve (It, aksijalni prikaz) Strijatalno područje (s, aksijalni prikaz)
This is equivalent to approximately 2% of the adult recommended maximum daily dietary intake for sodium These amounts may need to be considered for people on a low sodium diet.
To odgovara približno 2% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections.
Pomoćne tvari: etanol bezvodni, polisorbat 80, natrijev klorid, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, voda za injekcije.
VIZAMYL is supplied in a 10-mL or 15-mL glass vial.
VIZAMYL se isporučuje u staklenim bočicama od 10 ml ili 15 ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x m L YYYY MBq at reference time.
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA xx,x ml GGGG MBq u referentno vrijeme.
VIZAMYL PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right).
VIZAMYL PET slučajevi koji pokazuju primjere negativne PET snimke (lijevo) i pozitivne snimke (desno) s flutemetamolom (18F).
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%).
U sekundarnoj analizi koja je koristila standard istine određen prema području maksimalne gustoće neuritičkih plakova u 3 neokortikalna područja, preporučena od CERAD-a osjetljivost je iznosila 92% (95% CI: 83% do 97%), a specifičnost 88% (95% CI: 71% do 97%).
When in doubt, it is important to consult the nuclear medicine doctor who will supervise the procedure.
U slučaju bilo kakve sumnje, važno je posavjetovati se s liječnikom specijalistom nuklearne medicine koji će nadgledati postupak.
In vitro, flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain, with negligible binding to neurofibrillary tangles.
In vitro, flutemetamol (18F) se veže za β-amiloidne neuritičke plakove u mozgu, uz zanemarivo vezivanje na neurofibrilarne čvorove.
VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F).
Snimke dobivene pomoću VIZAMYL-a trebali bi tumačiti samo specijalisti educirani za tumačenje PET snimaka s flutemetamolom (18F).
In a re-reading study that increased the patient population of the pivotal study to include 38 additional autopsied patients (i.e., 106 in total), sensitivity and specificity for detection of moderate-frequent βamyloid neuritic plaque density in the primary analysis were 91% (95% CI: 82% to 96%) and 90% (95% CI: 74% to 98%), respectively, based on the majority read (i.e., the image interpretation reached by at least 3 of the 5 readers after electronic training).
U ispitivanju u kojem je rađeno ponovno očitavanje povećana je populacija bolesnika u odnosu na ključno ispitivanje uključivanjem 38 dodatno obduciranih bolesnika (tj. ukupno 106), osjetljivost i specifičnost u utvrđivanju umjerene i učestale gustoće β-amiloidnih neuritičkih plakova u primarnim analizama je bila 91% (95% CI: 82% do 96%), odnosno 90% (95% CI: 74% do 98%), na temelju većine očitanja (tj. interpretacija slike od strane barem 3 od 5 tumača slika nakon elektronske obuke).
The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised.
Farmakokinetika flutemetamola (18F) u bolesnika s oštećenjem funkcije bubrega ili jetre nije okarakterizirana.
At the 36-month follow-up, 81 (35%) converted to clinical AD. Of the 97 aMCI patients who had a positive PET scan and at least one committee assessment, 52 (54%) were classified clinically as converted to clinical AD after 36 months compared to 29 (23%) of 127 who had a negative scan and at least one committee assessment.
Od 97 s amnestičkim blagim kognitivnim oštećenjem koji su imali pozitivnu PET snimku i barem jednu procjenu odbora, u 52 (54%) je dijagnosticirana klinički AB nakon 36 mjeseci, u usporedbi s 29 (23%) od 127 koji su imali negativnu snimku i barem jednu procjenu odbora.
One multidose vial of 15-mL capacity contains 1 to 15 mL of solution, corresponding to 400 to 6000 MBq at reference date and time.
Jedna višedozna bočica kapaciteta 15 ml sadrži 1 do 15 ml otopine, što odgovara 400 do 6000 MBq na referentni datum i vrijeme.
Breast-feeding It is not known whether flutemetamol (18F) is excreted in human milk during breast-feeding.
Dojenje Nije poznato izlučuje li se flutemetamol (18F) u majčino mlijeko tijekom dojenja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 400 MBq of flutemetamol (18F) at reference date and time.
KVALITATIVNI I KVANTITATIVNI SASTAV Svaki ml otopine za injekciju sadrži 400 MBq flutemetamola (18F) na referentni datum i vrijeme.
One multidose vial of 10-mL capacity contains 1 to 10 mL of solution, corresponding to 400 to 4000 MBq at reference date and time.
Jedna višedozna bočica kapaciteta 10 ml sadrži 1 do 10 ml otopine, što odgovara 400 do 4000 MBq na referentni datum i vrijeme.
VIZAMYL is for intravenous use.
Način primjene VIZAMYL je namijenjen za intravensku primjenu.
INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
If the integrity of the vial is compromised, the medicinal product should not be used.
Ako je bočica oštećena, lijek se ne smije koristiti.
VIZAMYL is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment.
VIZAMYL je radiofarmaceutik indiciran za određivanje gustoće β-amiloidnih neuritičkih plakova pozitronskom emisijskom tomografijom (PET) u mozgu odraslih bolesnika s kognitivnim oštećenjima u kojih se sumnja na Alzheimerovu bolest (AB) ili neki drugi uzrok smanjenja kognitivnih sposobnosti.
Other medicines and VIZAMYL
Drugi lijekovi i VIZAMYL
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%).
U 68 bolesnika, specifičan vizualni PET snimak bez poznavanja identiteta bolesnika očitan od strane 5 tumača slika rezultirao je osjetljivošću od 86% (95% CI: 72% do 95%) i specifičnošću od 92% (95% CI: 74% do 99%).
At 36 months, sensitivity of flutemetamol (18F) scans for predicting conversion from aMCI to AD in 81 converters was 64 % (95% CI: 54% to 75 %), specificity in 143 non-converters was 69% (95% CI: 60% to 76 %).
Nakon 36 mjeseci, osjetljivost snimaka dobivenih pomoću flutemetamola (18F) u predviđanju progresije amnestičkog blagog kognitivnog oštećenja u Alzheimerovu bolest u 81 bolesnika iznosila je 64% (95% CI: 54% do 75%), specifičnost u 143 bolesnika koji nisu progredirali iznosila je 69% (95% CI: 60% do 76 %).
SHIELD LABEL / 15 mL
NALJEPNICA NA ZAŠTITNOM PAKIRANJU / 15 ml
What VIZAMYL contains The active substance is flutemetamol (18F).
Što VIZAMYL sadrži Djelatna tvar je flutemetamol (18F).
VIZAMYL should be used in conjunction with a clinical evaluation.
VIZAMYL je potrebno primjenjivati uz odgovarajuću kliničku procjenu bolesnika.
The frequencies of adverse reactions are defined as follows:
Učestalost nuspojava definirana je kako slijedi:
If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku specijalistu nuklearne medicine koji nadgleda postupak.
• 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.
• Informacije o amiloidnoj patologiji kod Alzheimerove bolesti; važne podatke o VIZAMYL-u kao β-amiloidnom PET obilježivaču, uključujući odobrene indikacije prema SmPC-u,
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, Francuska Seibersdorf Labor GmbH, 2444 Seibersdorf, Austrija Instituto Tecnológico PET, SA, 28040 Madrid, Španjolska Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Španjolska Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italija Nucleis SA, 4000 Liège, Belgija
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GE Healthcare AS
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GE Healthcare AS
IV
V
Osteogenic cells Ovaries
Osteogene stanice
Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Nastavak dojenja morate dogovoriti s liječnikom specijalistom nuklearne medicine koji će nadgledati postupak.
Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Oštećenje funkcije bubrega/jetre Farmakokinetika kod bolesnika s oštećenjem funkcije bubrega ili jetre nije okarakterizirana.
How VIZAMYL is stored
Kako se primjenjuje VIZAMYL
Ethanol, anhydrous
Etanol, bezvodni
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Čuvanje radiofarmaceutika mora biti u skladu s nacionalnom regulativom o radioaktivnim tvarima.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA VIZAMYL 400 MBq/ml otopina za injekciju flutemetamol (18F) i.v.
For precautions with respect to environmental hazard see section 6.6.
Za mjere opreza vezano uz onečišćenje okoliša vidjeti dio 6.6.
The patient's head should be tilted so that the anterior commissure-posterior commissure (ACPC) plane is at right angles to the bore-axis of the PET scanner with the head positioned in a suitable head support.
Postavite odgovarajući podložak ispod bolesnikove glave i podignite mu bradu tako da prednja i stražnja komisurna linija (ACPC) budu pod pravim kutovima u odnosu na os PET snimača.
Reducing head movement with tape or other flexible head restraints may be employed.
Možete dodatno pričvrstiti bolesnikovu glavu pomoću trake ili drugog fleksibilnog stabilizatora kako biste ograničili pomicanja glave.
Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Čuvanje radiofarmaceutika bit će u skladu s nacionalnim propisima o radioaktivnim tvarima.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / 15 mL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI / 15 ml
If at any time in the preparation of this product the integrity of the vial is compromised, it should not be used.
Ako se za vrijeme pripreme lijeka bočica ošteti, lijek se ne smije koristiti.
GE Healthcare d.o.o.
GE Healthcare B.V.
This may need to be taken into consideration by patients on a controlled sodium diet.
Tu je činjenicu potrebno uzeti u obzir u bolesnika na prehrabi s kontroliranim unosom natrija.
SPECIAL STORAGE CONDITIONS Storage in accordance with national regulation on radiopharmaceuticals.
Skladištiti u skladu s nacionalnim propisima o radiofarmaceuticima.
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, Francuska Seibersdorf Labor GmbH, 2444 Seibersdorf, Austrija Instituto Tecnológico PET, SA, 28040 Madrid, Španjolska Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Španjolska 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, Njemačka
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.
Pri rekonstrukciji iterativne projekcije ili unatražne projekcije filtriranih podataka preporučuje se debljina slojeva od 2 do 4 mm i veličina aksijalne matrice od 128 x 128 s veličinom piksela od otprilike 2 mm.
There is no evidence of flutemetamol (18F) binding to soluble forms of
Nema dokaza o vezivanju flutemetamola (18F) za topljive oblike amiloida.
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).
U slučaju nejasnoća u lokalizaciji sive tvari i granice između sive i bijele tvari na PET snimci preporuča se fuzionirati snimku s nedavno učinjenom kompjuteriziranom tomografijom (CT) ili magnetskom rezonancom (MR) kako bi se dobile PET-CT ili PET-MR snimke (vidjeti dio 4.4 Interpretacija snimaka dobivenih pomoću VIZAMYL-a).
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
imate problema s bubrezima imate problema s jetrom ste trudni ili mislite da biste mogli biti trudni dojite
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / 10 mL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI / 10 ml
Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time.
Svaki ml otopine sadrži 400 MBq flutemetamola (18F) na referentni datum i vrijeme.
Lower large intestine wall Lungs
Stijenka donjeg dijela debelog crijeva Pluća
Tell your doctor straight away if you notice any of the signs above.
Ako primijetite bilo koji od gore navedenih simptoma, odmah obavijestite svog liječnika.
GE International Inc. Tel: +371 780 7086
Tel: +371 780 7086
No carcinogenicity and reproductive toxicology studies have been performed with flutemetamol (18F).
S flutemetamolom (18F) nisu provođene studije kancerogenosti i reproduktivne toksičnosti.
You should avoid any close contact with young children for 24 hours following the injection.
Trebate izbjegavati bilo kakav bliski kontakt s malom djecom tijekom prvih 24 sata nakon injekcije.
VIZAMYL is for multidose use.
VIZAMYL je namijenjen za višekratnu primjenu.
Upper large intestine Bladder
Gornji dio debelog crijeva Mjehur
Facial hypoaesthesia Pruritus
Hipoestezija lica Pruritus
Chest discomfort Feeling hot Asthenia Fatigue
Nelagoda u prsištu Osjećaj vrućine Astenija
If you get any side effects, talk to your nuclear medicine doctor.
Ako imate bilo kakvih pitanja, kontaktirajte svog liječnika specijalista nuklearne medicine.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL / 10 mL
NALJEPNICA NA ZAŠTITNOM PAKIRANJU / 10 ml
Close contact with infants should be restricted during the initial 24 hours following injection.
Potrebno je izbjegavati bliski kontakt s djecom tijekom prvih 24 sata nakon injekcije.
can detect β-amyloid diffuse plaques when they are frequent.
In vivo, flutemetamol (18F) može detektirati β-amiloidne difuzne plakove kada su učestali.
VIZAMYL is supplied in 10-mL and 15-mL Type I glass vials with halobutyl rubber stoppers and aluminium seals.
VIZAMYL se isporučuje u bočicama od 10 ml i 15 ml od stakla tipa
Multidose vial
Veličina pakiranja
A positive scan indicates a moderate to frequent density.
Pozitivan rezultat snimanja znači srednju do visoku gustoću.
A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Negativan rezultat snimanja karakteriziran je rijetkim plakovima ili nepostojanjem plakova, što nije u skladu s dijagnozom AB.
Skin tightness Swelling face
Zatezanje kože Oticanje lica
Anaphylactoid reaction
Krvožilni poremećaji
Dyspnoea Hyperventilation Throat irritation
Dispneja Hiperventilacija
Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dodecahydrate Water for injections
Natrijev hidrogenfosfat dodekahidrat
Advanced Accelerator Applications S.r.l.
Advanced Accelerator Applications S.r.l. Via Ribes 5
GE Healthcare Inc. Tel.: +370 68 723 753
Tel.: +370 68 723 753
Pallor
Gušterača
Tel: + 385 1 6170 280
GE Healthcare d.o.o. Tel: + 385 1 6170 280
Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
Nakon postupka Potrebno je izbjegavati bliski kontakt s djecom i trudnicama tijekom prvih 24 sata nakon injekcije.
Muscle tightness Musculoskeletal pain
Nadbubrežne žlijezde Mozak
Contact your nuclear medicine doctor if you have any questions.
Razgovarajte sa svojim liječnikom specijalistom nuklearne medicine prije nego primite VIZAMYL ako:
Interpretation of VIZAMYL images
Primjena VIZAMYL-a i provedba postupka
Gastrointestinal disorders
Mučnina Povraćanje Dispepsija
If you are breast-feeding
Žučni mjehur
The recommended dose is 300 micrograms per kilogram body weight once every 3 weeks.
Preporučena doza iznosi 300 mikrograma po kilogramu tjelesne težine jednom svaka 3 tjedna.
Further information on Onpattro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Više informacija o lijeku Onpattro možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Onpattro?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Onpattro?
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.
Najčešće nuspojave povezane s lijekom Onpattro (mogu se javiti u više od 1 na 10 osoba) jesu periferni edem (oticanje, osobito gležnjeva i stopala) i reakcije povezane s infuzijom, uključujući bol, mučninu, glavobolju, umor, vrtoglavicu, kašalj i probleme s disanjem, crvenilo kože, brz rad srca, nizak ili visok krvni tlak i oticanje lica.
What is Onpattro and what is it used for?
Što je Onpattro i za što se koristi?
The medicine is available as a solution for infusion (drip) into a vein.
Lijek je dostupan kao otopina za infuziju (drip) u venu.
What are the risks associated with Onpattro?
Koji su rizici povezani s lijekom Onpattro?
Onpattro may be given at home by a healthcare professional if the patient has had at least 3 infusions given in hospital without problems.
Zdravstveni radnik može dati lijek Onpattro kod kuće ako je bolesnik primio barem 3 infuzije u bolnici bez problema.
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Više informacija o statusu lijeka za rijetke bolesti možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Side effects reported with Onpattro are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Onpattro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Why is Onpattro authorised in the EU?
Zašto je lijek Onpattro odobren u EU-u?
Regarding safety, the most serious side effects are infusion-related reactions and these can be managed with premedication and changes to infusion speed.
Kad je riječ o sigurnosti, najteže su nuspojave reakcije povezane s infuzijom, kojima se može upravljati premedikacijom i promjenama u brzini infuzije.
As for all medicines, data on the use of Onpattro are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Onpattro kontinuirano se prate.
For more information about using Onpattro, see the package leaflet or contact your doctor or pharmacist.
Za više informacija o primjeni lijeka Onpattro pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
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).
Onpattro se primjenjuje u odraslih bolesnika u prvim dvama stadijima oštećenja živaca (1. stadij, kada bolesnik može hodati bez pomoći i 2. stadij, kada bolesnik može hodati, ali mu je potrebna pomoć).
Onpattro contains the active substance patisiran.
Onpattro sadrži djelatnu tvar patisiran.
The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Raspadnuti protein stvara nakupine amiloida u tkivu i organima u tijelu, uključujući i oko živaca, i ometa njihove normalne funkcije.
An overview of Onpattro and why it is authorised in the EU
Pregled informacija o lijeku Onpattro i zašto je odobren u EU-u
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.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Onpattro nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.