natgillin/translations-raw huggingface dataset:
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients (see section 4.4).
Količino uporabljene aktivnosti je treba skrbno pretehtati, saj je pri teh bolnikih izpostavljenost sevanju lahko večja (glejte poglavje 4.4).
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
NAVODILA ZA PRIPRAVO RADIOFARMAKOV Način priprave
This dose is approximately 500 times the maximum human dose, and showed no evidence of mutagenicity.
krat višji od najvišjega odmerka pri ljudeh in ni dal dokazov o mutagenosti.
As a result of differences in the manufacturing process, it is possible that vials of some product batches are distributed with punctured rubber stoppers.
Zaradi razlik pri proizvodnem procesu obstaja možnost, da imajo viale nekaterih serij zdravila prebodene gumijaste zamaške.
If a CT scan is simultaneously performed as part of the PET procedure, exposure to ionising radiation will increase in an amount dependent on the settings used in the CT acquisition.
Če se hkrati kot del PET-postopka opravi CT-preiskava, se izpostavljenost ionizirajočemu sevanju poveča za količino, odvisno od nastavitev, uporabljenih pri slikanju s CT.
In AD subjects, cortical regions and putamen show significantly greater uptake compared to controls.
Pri preiskovancih z AB kortikalna področja in putamen kažejo značilno večji privzem v primerjavi s kontrolami.
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities (i.e. genetic diseases).
S tem radiofarmakom prejmete majhne količine ionizirajočega sevanja, povezanega z najmanjšim tveganjem za razvoj raka in dednih nenormalnosti (tj. genetskih bolezni).
- The other ingredients are ethanol, sodium ascorbate, sodium chloride, water for injections (see section 2 “Amyvid contains ethanol and sodium”).
- Druge sestavine zdravila so etanol, natrijev askorbat, natrijev klorid, voda za injekcije (glejte poglavje 2 »Zdravilo Amyvid vsebuje etanol in natrij«).
In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defaecation.
V primeru uporabe prevelikega odmerka sevanja je treba odmerek, ki ga bolnik absorbira, čim bolj zmanjšati, tako da bolnik poveča izločanje radionuklida iz telesa s pogostim uriniranjem in odvajanjem blata.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila, http://www.ema.europa.eu/.
In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to help remove radioactivity from your body.
Zdravnik nuklearne medicine, odgovoren za postopek, lahko še zlasti poskrbi za povečano odvajanje urina in blata, da pospešite izločanje radioaktivnosti iz telesa.
Elderly No dose adjustment is recommended based on age.
Prilagoditev odmerka na osnovi starosti ni potrebna.
Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Pred dajanjem radiofarmaka doječi materi je treba razmisliti o možnosti preložitve dajanja radionuklida na kasnejši čas, dokler mati ne neha dojiti, in o izbiri najustreznejšega radiofarmaka, ob upoštevanju izločanja aktivnosti v materino mleko.
This should be taken into account in patients with a low sodium diet.
To je treba upoštevati pri bolnikih na dieti z malo natrija.
It is hypothesised that slower clearance of the radiopharmaceutical may contribute to white matter retention since regional cerebral blood flow in white matter is less than half of that of cortex.
Obstaja hipoteza, da k zadrževanju v beli možganovini morda prispeva počasnejši očistek radiofarmaka, saj je regionalni cerebralni krvni obtok v beli možganovini za polovico manjši od obtoka v skorji.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
Effective Dose [µSv/MBq]a a Assumed quality factor (Q) of 1 for conversion of absorbed dose to effective dose for 18F.
Učinkoviti odmerek [µSv/MBq]a a Privzeti faktor kakovosti (Q) 1 za pretvorbo absorbiranega odmerka v učinkoviti odmerek za 18F.
In a chromosomal aberration in vitro study with cultured human peripheral lymphocyte cells, florbetapir did not increase the percent of cells with structural aberrations with 3 hour exposure with or without activation; however, 22 hour exposure produced an increase in structural aberrations at all tested concentrations.
V študiji kromosomskih aberacij in vitro z gojenimi humanimi perifernimi limfocitnimi celicami florbetapir pri triurni izpostavljenosti z aktivacijo ali brez nje ni povečal odstotka celic s strukturnimi aberacijami, 22-urna izpostavljenost pa je povzročila povečano število strukturnih aberacij pri vseh preskušanih koncentracijah.
Manufacturer For information on the manufacturer, see vial and shield label.
Za informacije o izdelovalcu glejte vialo in oznako na zaščiti.
Florbetapir (18F) is excreted primarily through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure (see section 4.2).
Florbetapir (18F) se izloča predvsem prek hepatobiliarnega sistema, zato pri bolnikih z okvaro jeter obstaja možnost večje izpostavljenosti sevanju (glejte poglavje 4.2).
The reason for this uptake is unknown, but may be due to accumulation of florbetapir (18F) or to any of its radioactive metabolites or to blood radioactivity.
Razlog tega privzema ni znan, morda pa je posledica kopičenja florbetapirja (18F), katerega od njegovih radioaktivnih presnovkov ali radioaktivnosti krvi.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Izpostavljanje ionizirajočemu sevanju je povezano s pojavom raka in z možnostjo razvoja dednih okvar.
Participating readers first evaluated a set of 96 PET scans, including 46 scans with autopsy standard of truth, using the visual qualitative read method to establish a baseline and were subsequently asked to re-evaluate the same set of scans with or without access to quantitative software information.
Sodelujoči odčitovalci so najprej ocenili niz 96 posnetkov PET, vključno s 46 posnetki z obdukcijskim standardom resnice, z uporabo vizualne kvalitativne metode odčitavanja za določitev izhodišča in so bili naknadno naprošeni, naj znova ocenijo isti niz posnetkov z ali brez dostopa do kvantitativnih podatkov programske opreme.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Uporabljena aktivnost mora biti v vsakem primeru najnižja možna, ki še omogoča želene diagnostične informacije.
No assumptions were made regarding urinary bladder voiding.
Predpostavk glede praznjenja sečnega mehurja ni bilo.
Readers should visually interpret the scan, then perform quantitation according to manufacturer's instructions, including quality checks of the quantitative process, and compare quantitation of scan with typical ranges for negative and positive scans.
Odčitovalci morajo vizualno tolmačiti sliko, nato izvesti kvantifikacijo v skladu z navodili izdelovalca, vključno s preverjanji kakovosti postopka kvantifikacije ter primerjati kvantifikacijo posnetka s tipičnimi obsegi za negativne in pozitivne posnetke.
One injection is usually sufficient to carry out the scan that your doctor needs.
Za izvedbo preiskave, ki jo potrebuje zdravnik, je običajno dovolj ena injekcija.
Regional analyses show slightly higher levels of retention in the caudate, putamen and hippocampus.
Regionalne analize so pokazale nekoliko višje zadrževanje v nucleusu caudatusu, putamnu in hipokampusu.
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.
Negativen rezultat preiskave kaže na redke ali odsotne lehe, kar se ne ujema z diagnozo AB. Za omejitve pri interpretaciji pozitivnega rezultata preiskave glejte poglavji 4.4 in 5.1.
In a study of 47 young (<40 years) healthy volunteers, presumed to be free of β-amyloid, all Amyvid PET scans were negative.
V študiji s 47 mladimi (<40 let), zdravimi prostovoljci, za katere so predpostavili, da nimajo β-amiloidov, so imele vse PET-preiskave z zdravilom Amyvid negativne rezultate.
Summary of the safety profile The safety profile of Amyvid is based on its administrations to 2,105 subjects in clinical trials.
Varnostni profil zdravila Amyvid temelji na uporabi zdravila pri 2.105 preiskovancih v kliničnih preskušanjih.
Method of preparation The package must be checked before use and the activity measured using an activimeter.
Pred uporabo je treba pregledati embalažo in z merilnikom aktivnosti izmeriti aktivnost.
This amount may be harmful for those suffering from alcoholism, and should be taken into account in pregnant and breast-feeding women and high-risk groups such as patients with liver disease or epilepsy.
Ta količina lahko škoduje osebam, ki trpijo za alkoholizmom, upoštevati pa jo je treba tudi pri nosečnicah in doječih materah ter pri ogroženih skupinah, kot so bolniki z jetrnimi boleznimi ali epilepsijo.
For each patient, the radiation exposure must be justifiable by the likely benefit.
Pri vsakem bolniku mora verjetna korist upravičiti izpostavljenost sevanju.
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
A brain scan is usually taken about 30 to 50 minutes after the Amyvid injection is given.
Preiskava možganov se ponavadi začne približno 30 do 50 minut po injekciji zdravila Amyvid.
Amyvid, along with other brain function tests, may help your doctor find the reason for your memory problems.
Zdravilo Amyvid lahko skupaj z drugimi testi delovanja možganov vašemu zdravniku pomaga ugotoviti vzrok za vaše težave s spominom.
Potential in vivo genotoxicity of florbetapir was evaluated in a rat micronucleus study.
Potencialno genotoksičnost florbetapirja in vivo so vrednotili v študiji mikronukleusov pri podganah.
An acute dose study was conducted in rats, and the NOAEL (no observable adverse effect level) was determined to be at least 100 times maximum human dose.
Na podganah so izvedli študijo z akutnim odmerkom, pri kateri so ugotovili, da je NOAEL (raven, pri kateri ni opaženih neželenih učinkov) vsaj 100-krat višja od najvišjega odmerka pri ljudeh.
Inter-rater agreement using Fleiss' kappa values ranged from 0.75 to 0.85.
Ujemanje med ocenjevanji, določeno z uporabo Fleissovih vrednosti kappa, je bilo v razponu med 0,75 in 0,85.
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Trajanje postopka Zdravnik nuklearne medicine vam bo povedal, kako dolgo ponavadi traja postopek.
The usual amount recommended for an adult is 370 MBq.
Običajno priporočena količina za odraslega je 370 MBq.
What Amyvid is and what it is used for
Kaj je zdravilo Amyvid in za kaj ga uporabljamo
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Pri načrtovanju dajanja radiofarmakov ženski v rodni dobi je pomembno ugotoviti, ali je ženska noseča.
• Information on amyloid pathology in Alzheimer Disease; relevant information on Amyvid as an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of Amyvid use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of Amyvid
• Informacije o patologiji amiloidov pri Alzheimerjevi bolezni; pomembne informacije o zdravilu Amyvid kot sledilnika β-amiloida pri PET-preiskavi, vključno z odobreno indikacijo v skladu s povzetkom glavnih značilnosti zdravila, omejitvami uporabe zdravila Amyvid, napakami pri interpretaciji, varnostnimi informacijami in rezultati kliničnih preskušanj, ki dajejo informacije o diagnostični uporabi zdravila Amyvid
You should discuss the results of the test with the doctor that requested the scan.
O rezultatih testa se pogovorite z zdravnikom, ki je preiskavo naročil.
Less than 5% of the injected 18F radioactivity remains in blood 20 minutes following administration, and less than 2% is present 45 minutes after administration.
Po 20 minutah po dajanju ostane v krvi manj kot 5 % injicirane radioaktivnosti 18F, po 45 minutah pa manj kot 2 %.
Review of images should be primarily in the transaxial orientation with access as needed to the sagittal and coronal planes.
Slike so pregledujejo predvsem v transaksialni smeri, po potrebi z dostopom do sagitalne in koronarne ravnine.
Cortical average SUV ratios (SUVRs, relative to cerebellum) are higher in AD patients compared with those of healthy volunteer subjects.
Povprečna kortikalna razmerja SUV (SUVR, glede na male možgane) so višja pri bolnikih z AB kot pri zdravih prostovoljcih.
The PET results were compared with the maximal neuritic plaque density measured on sections of frontal, temporal or parietal cortex at the patient's autopsy within 24 months of PET scan.
Rezultate PET-preiskave so primerjali z maksimalno gostoto nevritičnih leh, izmerjeno na delih frontalne, temporalne ali parietalne skorje med obdukcijo bolnika v 24 mesecih po PET-preiskavi.
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Amyvid is marketed, at launch and after launch, all physicians who are expected to use Amyvid have access to a training course in order to ensure accurate and reliable interpretation of the PET images.
Imetnik dovoljenja za promet z zdravilom mora po pogovorih in v dogovoru z nacionalnim pristojnim organom v vsaki državi članici, kjer se zdravilo Amyvid trži, ob in po vpeljavi zdravila na trg poskrbeti, da imajo vsi zdravniki, ki naj bi uporabljali zdravilo Amyvid, dostop do izobraževanja, s katerim se zagotovi pravilna in zanesljiva interpretacija PET-posnetkov.
Incorporation of quantitative information generated by CE-marked image quantitation software as an adjunct to the visual interpretation method may improve readers' accuracy.
Vključevanje kvantitativnih podatkov, ki jih ustvari programska oprema za kvantifikacijo posnetkov z oznako CE kot dodatek vizualni interpretacijski metodi, lahko poveča natančnost odčitovalcev.
The spatial normalisation and fit of the scan to the template should be re-checked to confirm the accuracy of the placement of the regions of interest (ROIs), search for CSF or bone within the ROI, and evaluate the potential impact of atrophy or ventriculomegaly on quantitation.
Znova preverite prostorsko normalizacijo in ujemanje posnetka s predlogo, da boste potrdili natančnost namestitve regij zanimanja (ROI - Regions of interest), iskanje cerebrospinalnega likvorja ali kosti v okviru ROI ter ocenite morebitni vpliv atrofije ali ventrikulomegalije na kvantifikacijo.
EXPIRY DATE EXP {DD/MM/YYYY} {hh:mm}{Time Zone}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {DD/MM/LLLL} {hh:mm}{Time Zone}
Other medicines and Amyvid
Druga zdravila in zdravilo Amyvid
Agreement with baseline diagnosis of clinical AD
Ujemanje z izhodiščno diagnozo klinične AB
Only polypropylene/HDPE syringes should be used.
Uporabite lahko samo injekcijske brizge iz polipropilena/HDPE.
The complete SmPC of Amyvid is provided as a separate document in the medicinal product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Povzetek glavnih značilnosti zdravila Amyvid je v celoti podan kot ločen dokument navodil za uporabo zdravila, in sicer z namenom, da zdravstvenemu osebju nudi dodatne znanstvene in praktične informacije o uporabi tega radiofarmaka.
Final panel to right shows enlarged picture of the brain area in the box.
Zadnja slika na desni strani prikazuje povečan posnetek dela možganov v okvirčku.
Interpretation of the image as negative or positive is made by visually comparing the activity in cortical grey matter with activity in adjacent white matter (see Figure 1).
Slika se interpretira kot pozitivna ali negativna, tako da se vizualno primerja aktivnost v sivi možganovini z aktivnostjo v sosednji beli možganovini (glejte sliko 1).
Amyvid must not be used after the expiry date which is stated on the shield label after EXP.
Zdravila Amyvid ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki zaščite poleg oznake 'EXP'.
A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (Alzheimer's disease, Lewy body dementia, Parkinson's disease dementia).
Omejitve uporabe Pozitiven rezultat preiskave sam po sebi ne postavlja diagnoze AB ali druge kognitivne okvare, saj je odlaganje nevritičnih leh v sivi možganovini lahko prisotno pri asimptomatskih starejših osebah in pri nekaterih nevrodegenerativnih demencah (Alzheimerjeva bolezen, demenca z Lewyjevimi telesci, demenca pri Parkinsonovi bolezni).
For an administered activity of 370 MBq the typical radiation dose to the target organ (brain) is 3.7 mGy.
Pri uporabljeni aktivnosti 370 MBq je tipični odmerek sevanja, ki ga prejme ciljni organ (možgani), 3,7 mGy.
Dose absorbed per activity administered (µGy/MBq) Average
Absorbiran odmerek na enoto dane aktivnosti (µGy/MBq)
Osteogenic cells
Osteogene celice Koža
In an in vitro bacterial reverse mutation assay (Ames test), increases in the number of revertant colonies were observed in 2 of the 5 strains exposed to florbetapir.
Pri bakterijskem testu reverzne mutacije in vitro (Amesov test) so opazili povečano število kolonij povratnih mutantov pri dveh od petih sevov, izpostavljenih florbetapirju.
Only clear solutions, free of visible particles should be used.
Uporabite lahko samo bistre raztopine, ki ne vsebujejo vidnih delcev.
For an administered activity of 370 MBq the typical radiation doses delivered to the critical organs, gallbladder, upper large intestine wall, lower large intestine wall, small intestine and liver are 53 mGy, 27.5 mGy, 10.3 mGy, 24.2 mGy and 23.8 mGy, respectively.
Pri prejeti aktivnosti 370 MBq so tipični odmerki sevanja, ki jih prejmejo bistveni organi, tj. žolčnik, stena zgornjega debelega črevesa, stena spodnjega debelega črevesa, tanko črevo in jetra, 53 mGy, 27,5 mGy, 10,3 mGy, 24,2 mGy oziroma 23,8 mGy.
The organs of greatest exposure are organs of elimination, mainly the gallbladder, liver, and intestines.
Najbolj izpostavljeni organi so organi izločanja, v glavnem žolčnik, jetra in prebavila.
Figure 1: Amyvid PET cases showing examples of negative scans (top two rows) and positive scans (bottom two rows).
Slika 1: Slikanje s PET z zdravilom Amyvid, ki prikazuje primere negativnih rezultatov preiskave (zgornji dve vrstici) in pozitivnih rezultatov preiskave (spodnji dve vrstici).
Animal toxicology and safety pharmacology
Toksikologija pri živalih in farmakološka varnost
If the integrity of the vial is compromised it should not be used.
Če je integriteta viale ogrožena, je ne smete uporabiti.
A positive scan indicates moderate to frequent density.
Pozitiven rezultat preiskave kaže na zmerno do pogosto gostoto.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja in vivo niso izvedli.
Injection of florbetapir (18F) through a short intravenous catheter (approximately 4 cm or less) minimises the potential for adsorption of the active substance to the catheter.
Injiciranje florbetapirja (18F) preko kratkega intravenskega katetra (dolžine približno 4 cm ali manj) zmanjša možnost adsorpcije učinkovine na kateter.
However, in the case of an overdose, you will receive the appropriate treatment.
Če se to vseeno zgodi, bo zdravnik uvedel primerno zdravljenje.
Sensitivity and specificity to detect the cortical neuritic plaque density of Amyvid was further investigated in two additional studies, in which different sets of readers interpreted images from some subjects followed to autopsy in the pivotal study.
Občutljivost in specifičnost zdravila Amyvid za ugotavljanje gostote kortikalnih nevritičnih leh so nadalje preiskovali v dveh dodatnih študijah, pri katerih so različne skupine odčitovalcev interpretirale slike nekaj preiskovancev, ki so jim v ključni študiji sledili do obdukcije.
Sensitivity of Amyvid scan to show the MCI conversion rate to AD in 9 converters was 66.7% (95% CI: 35-88%), specificity in 38 non-converters was 71.0% (95% CI: 55-83%) and positive likelihood ratio was 2.31 (95% CI: 1.2-4.5).
Občutljivost preiskave z zdravilom Amyvid za dokaz stopnje prehoda zmerne kognitivne okvare v AB pri 9 preiskovancih, pri katerih je prišlo do prehoda, je bila 66,7 % (95-odstotni IZ: 35-88 %), specifičnost pri 38 preiskovancih, pri katerih ni prišlo do prehoda, je bila 71,0 % (95-odstotni IZ: 55-83 %), pozitivno razmerje verjetja pa je bilo 2,31 (95-odstotni IZ: 1,2-4,5).
The potential toxicity of 28 days of repeated intravenous injections of florbetapir was tested in rats and dogs, and the NOAEL was found to be at least 25 times the maximum human dose.
Na podganah in psih o preskušali morebitno toksičnost z 28-dnevnim ponavljajočim se injiciranjem florbetapirja in določili, da je NOAEL vsaj 25-krat višja od najvišjega odmerka pri ljudeh.
The recommended activity for an adult weighing 70 kg is 370 MBq florbetapir (18F).
Priporočena aktivnost za odraslega, ki tehta 70 kg, je 370 MBq florbetapirja (18F).
The biophysical basis of the white matter retention of florbetapir (18F) in the living human brain cannot be definitively explained.
Biofizikalne osnove zadrževanja florbetapirja (18F) v beli možganovini živih ljudi ni mogoče dokončno pojasniti.
Adjunctive use of quantitative information for image interpretation:
Dodatna uporaba kvantitativnih podatkov za interpretacijo posnetkov
Method of administration Amyvid is for intravenous use and multidose use.
Zdravilo Amyvid je namenjeno za intravensko uporabo in za večodmerno uporabo.
Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
1/100), redki (> 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi razpoložljivih podatkov).
Due to the small quantity of florbetapir (18F) in each dose, overdose is not expected to result in pharmacological effects.
Zaradi majhne količine florbetapirja (18F) v posameznem odmerku ni pričakovati, da bi imelo preveliko odmerjanje farmakološke učinke.
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images obtained from the brain scan.
Obvestite zdravnika nuklearne medicine, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo, saj bi ta lahko motila interpretacijo slik,
For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Za omejitve uporabe pri bolnikih z zmerno kognitivno okvaro glejte poglavje 5.1.