natgillin/translations-raw huggingface dataset:
Posaconazole Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Predpisovanje in izdaja zdravila Posaconazole Accord je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem glivičnih okužb ali bolnikov z visokim tveganjem za invazivne glivične okužbe.
As for all medicines, data on the use of Posaconazole Accord are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Posaconazole Accord stalno spremljajo.
What are the benefits and risks of Posaconazole Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Posaconazole Accord?
What is Posaconazole Accord and what is it used for?
Kaj je zdravilo Posaconazole Accord in za kaj se uporablja?
• invasive aspergillosis (fungal infection caused by Aspergillus),
• invazivne aspergiloze (glivične okužbe, ki jo povzročajo glive iz rodu Aspergillus),
Why is Posaconazole Accord authorised in the EU?
Zakaj je bilo zdravilo Posaconazole Accord odobreno v EU?
Other information about Posaconazole Accord
Druge informacije o zdravilu Posaconazole Accord
The active substance in Posaconazole Accord, posaconazole, is an antifungal medicine that belongs to the triazole group.
Učinkovina zdravila Posaconazole Accord, posakonazol, je protiglivično zdravilo iz skupine triazolov.
Posaconazole Accord contains the active substance posaconazole and is a ‘generic medicine'.
Zdravilo Posaconazole Accord vsebuje učinkovino posakonazol in je „generično zdravilo“.
• fusariosis (fungal infection caused by Fusarium),
• fuzarioze (glivične okužbe, ki jo povzročajo glive iz rodu Fusarium),
Therefore, the Agency's view was that, as for Noxafil, the benefit of Posaconazole Accord outweighs the identified risk and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Posaconazole Accord enako kot pri zdravilu Noxafil odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
The list of fungi Posaconazole Accord is active against can be found in the summary of product characteristics.
Seznam glivic, proti katerim učinkuje zdravilo Posaconazole Accord, je na voljo v povzetku glavnih značilnosti zdravila.
How has Posaconazole Accord been studied?
Kako je bilo zdravilo Posaconazole Accord raziskano?
How is Posaconazole Accord used?
Kako se zdravilo Posaconazole Accord uporablja?
How does Posaconazole Accord work?
Kako zdravilo Posaconazole Accord deluje?
Activity: {XXX} MBq in {XX} mL ToC: {DDMMYYYY} {XX}h{XX} {Time zone} Volume: {XX} mL
Aktivnost: {XXX} MBq v {XX} ml ToC: {DDMMLLLL} {XX}h{XX} {časovni pas} Prostornina: {XX} ml
Up to 10 hours from the end of the synthesis.
Do 10 ur od konca sinteze.
The training programme should contain the following key elements:
Program usposabljanja mora vsebovati naslednje ključne elemente:
DATE OF REVISION OF THE TEXT 11.
DATUM ZADNJE REVIZIJE BESEDILA 11.
It might be helpful to estimate the effective dose that was applied.
Koristno je, da ocenite učinkoviti odmerek, ki je bil uporabljen.
EXP {DD/MM/YYYY} {XX}h{XX} {Time zone}
EXP {DD/MM/LLLL} {XX}h{XX} {časovni pas}
Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases.
Usposabljanje mora vključevati zadostno število nedvoumno pozitivnih in negativnih primerov ter vmesne primere.
Radioactive material.
radioaktivni material.
It will be the smallest amount necessary to get the desired information.
To bo najmanjša potrebna količina, s katero bodo pridobili potrebne informacije.
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Obstajajo strogi zakoni o uporabi, ravnanju in odstranjevanju radiofarmakov.
Repeat dosing in yearly intervals showed that there was no difference in safety profile after first, second or third dosing.
Ponavljajoči se odmerki v letnih intervalih so pokazali, da ni bilo razlik med varnostnimi profili po prvem, drugem ali tretjem odmerku.
Dosimetry calculations were adapted to the adult model (with a body weight of 70 kg).
Dozimetrični izračuni so bili prilagojeni na model odraslih (s telesno maso 70 kg).
Neuraceq is not intended for use in children and adolescents below the age of 18 years old.
Zdravilo Neuraceq ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
• Expertise and qualification of trainers should be ensured.
• Zagotoviti je treba strokovno usposobljene in kvalificirane izvajalce usposabljanja.
This medicine is intended for adults only.
Zdravilo je namenjeno samo za odrasle.
Individual benefit/risk justification
Utemeljitev koristi in tveganj za posameznika
• Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the read methodology;
• pregled meril PET-odčitavanja, vključno z metodo pregleda slik, merili za interpretacijo in slikami, ki predstavljajo metodologijo odčitavanja;
The adverse reactions are ranked under heading of frequency using the following convention: 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).
Neželeni učinki so razvrščeni po skupinah glede na pogostnost ob upoštevanju sledečih dogovorov: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Neuraceq should be used in conjunction with a clinical evaluation.
Neuraceq je treba uporabiti skupaj s kliničnim vrednotenjem.
This medicine will only be handled and given to you by professionals who are trained and qualified to use it safely.
Z zdravilom bodo ravnali in vam ga dajali le strokovnjaki, usposobljeni za njegovo varno uporabo.
Germany e-mail: gra@life-mi.com
E-pošta: gra@life-mi.com
The nuclear medicine doctor supervising the procedure will decide on the amount of Neuraceq to be used in your case.
Zdravnik nuklearne medicine, ki nadzira postopek, bo določil količino zdravila Neuraceq, ki bo uporabljena v vašem primeru.
The histopathology criteria did not match the CERAD criteria.
Merilo za histopatologijo se ni ujemalo z merilom CERAD.
In AD subjects, cortical regions and striatal regions show significantly greater uptake compared to controls.
Pri preiskovancih z AB kortikalne in striatne regije kažejo značilno večji privzem v primerjavi s kontrolami.
As a result of differences in the manufacturing process, it is possible that some vials are distributed with punctured rubber stoppers.
Zarad razlik pri proizvodnem procesu obstaja možnost, da imajo nekatere viale prebodene gumijaste zamaške.
The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 1,077 subjects and 12 subjects who received vehicle.
Celotni varnostni profil zdravila Neuraceq temelji na podatkih, ki se nanašajo na 1.295 aplikacij zdravila Neuraceq 1.077 preiskovancem in na 12 preiskovancev, ki so prejeli pomožno snov.
The cognitive status of the subjects could not be determined reliably.
Kognitivnega stanja preiskovancev ni bilo mogoče zanesljivo izmeriti.
Act.: ≤ 3000 MBq at ToC (see outer label)
Aktivnost: ≤ 3000 MBq ob ToC (glejte zunanjo ovojnino)
Residual activity in the midsagittal sinus can be sometimes observed likely due to the presence of tracer in the blood pool.
Včasih je mogoče opaziti rezidualno aktivnost v sagitalnem sinusu, verjetno zaradi prisotnosti označevalca v bazenu krvi.
The estimated absorbed radiation doses to organs are listed in Table 3, providing data from Caucasian healthy volunteers (n=17).
Ocenjeni odmerki sevanja, ki ga absorbirajo organi, so navedeni v Tabeli 3, podatki pa se nanašajo na zdrave prostovoljce kavkaške rase (n = 17).
Possible side effects include:
Med možne neželene učinke so vključeni:
- if you are allergic to florbetaben (18F) or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na [18F]florbetaben ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
ATC code: V09AX06
oznaka ATC: V09AX06.
The use of Neuraceq does involve exposure to small amounts of radioactivity.
Uporaba zdravila Neuraceq vključuje izpostavljenost majhnim količinam radioaktivnosti.
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Zdravnik nuklearne medicine vam bo povedal, če morate biti po prejemu tega zdravila na kaj še posebej pozorni.
Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Vaš osebni zdravnik in zdravnik nuklearne medicine sta pretehtala, da koristi tega postopka z radiofarmakom odtehtajo tveganja zaradi izpostavitve sevanju.
One multi-dose vial
Ena večodmerna viala
The administration of radiopharmaceuticals creates risks for other persons (including pregnant healthcare professionals) from external radiation or contamination from spill of urine, vomiting, etc.
Dajanje radiofarmakov pomeni tveganje za druge osebe (vključno z nosečimi zdravstvenimi delavkami) zaradi izpostavljenosti zunanjemu sevanju ali kontaminacije zaradi razlitja urina, bruhanja, itd.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Radiofarmake je treba pripraviti na način, ki bo zadoščal zaščiti pred sevanjem in farmacevtskim zahtevam glede kakovosti.
In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P450 enzyme system.
Študije in vitro ob uporabi človeških jetrnih mikrosomov niso pokazale možnosti za zaviranje encimskega sistema s citokromom P450.
METALLIC BOX (with Blue Box)
KOVINSKA ŠKATLA (z modrim okencem)
Neuraceq will only be used in specially controlled areas.
Zdravilo Neuraceq se uporablja samo v posebno nadzorovanih prostorih.
If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Če obstaja negotovost glede morebitne nosečnosti (če ženska ni dobila menstruacije, če je menstruacija zelo neredna itd.), je treba bolnici ponuditi alternativno tehniko (če je na voljo), ki ne vključuje uporabe ionizirajočega sevanja.
Blood creatinine increased
Zvišanje kreatinina v krvi
RCTU score 3 at least in one of 4 brain regions
RCTU-ocena 3 v vsaj eni od štirih regij v možganih
Chronic studies and carcinogenicity studies have not been carried out, since the medicinal product is not intended for regular or continuous administration.
Daljših študij in študij kancerogenosti niso izvedli, saj zdravilo ni namenjeno za redno ali neprekinjeno uporabo.
At 12 hours post injection 98.93% of the activity is decayed, at 24 hours post injection 99.99 % of the activity is decayed.
V 12 urah po injiciranju aktivni razpad doseže 98,93 %, v 24 urah po injiciranju pa 99,99 %.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advise before you are given this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden prejmete to zdravilo.
For precautions with respect to environmental hazard, see section 6.6.
Za previdnostne ukrepe v zvezi z nevarnostjo za okolje glejte poglavje 6.6.
PET images are read in a transaxial orientation using a grey scale.
PET-posnetki se odčitavajo v transaksialni smeri s sivinsko lestvico.
Neuraceq should not be diluted.
Neuraceq se ne sme razredčiti.
RCTU score 2 in any or all of the 4 brain regions and no score 3 in these 4 brain regions
RCTU-ocena 2 v kateri koli od štirih regij ali v vseh štirih regijah v možganih ter brez ocene 3 v teh štirih regijah
Radiation protection precautions in accordance with national regulations must therefore be taken.
Zato je treba v skladu z nacionalnimi predpisi sprejeti varnostne ukrepe za zaščito pred sevanjem.
The overall decision of the visual PET scan assessment is subject-based and based on a binary outcome as ‘positive' or ‘negative‘.
Skupna odločitev pri vizualnem vrednotenju PET-posnetkov se nanaša na preiskovanca in temelji na binarnem rezultatu kot "pozitivno" ali "negativno".
For each patient, the radiation exposure must be justified by the likely benefit.
Pri vsakem bolniku mora verjetna korist upravičiti izpostavljenost sevanju.
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 from the PET scan.
Obvestite zdravnika nuklearne medicine, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, saj lahko vpliva na interpretacijo posnetkov, narejenih s pozitronsko emisijsko tomografijo (PET).
The quantity to be administered usually recommended for an adult is 300 MBq (megabecquerel, the unit used to express radioactivity).
Količina, ki se običajno priporoča za odraslega, je 300 MBq (megabecquerel, enota za izražanje radioaktivnosti).
The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where Neuraceq is marketed, at launch and after launch, all physicians who are expected to use Neuraceq have access to a training programme in order to ensure accurate and reliable interpretation of the PET images.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da imajo po pogovoru in dogovoru s pristojnim nacionalnim organom v vsaki državi članici, kjer se trži zdravilo Neuraceq, ob začetku dajanja zdravila v promet in po tem vsi zdravniki, za katere se predvideva, da bodo uporabljali zdravilo Neuraceq, dostop do programa usposabljanja, da se zagotovi točna in zanesljiva interpretacija PET-slik.
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 defecation.
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.
Time points beyond that time frame did not allow for further quantitation of activity in urine.
Po tem obdobju nadaljnja kvantifikacija aktivnosti v urinu ni več mogoča.
One injection is sufficient to carry out the scan that your doctor needs.
Za izvedbo preiskave, ki jo potrebuje zdravnik, je dovolj ena injekcija.
Inter-rater agreement using Fleiss' kappa values ranged from 0.68 to 0.87.
Ujemanje med ocenjevanji je bilo ob uporabi Fleissovih vrednosti kappa v razponu med 0,68 in 0,87.
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, dokler mati ne neha dojiti, in o izbiri najustreznejšega radiofarmaka ob upoštevanju zadevnega izločanja v materino mleko.
This medicine is a radiopharmaceutical product for diagnostic use only.
To zdravilo je radiofarmak in je namenjeno samo za diagnostično uporabo.
Florbetaben (18F) is excreted primarily through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure (see section 4.2).
[18F]florbetaben se izloča predvsem prek hepatobiliarnega sistema, zato pri bolnikih z jetrno okvaro obstaja možnost večje izpostavljenosti sevanju (glejte poglavje 4.2).
Residual activity in the midsagittal sinus can be sometimes observed (see section 5.2).
Včasih je mogoče opaziti rezidualno aktivnost v srednjem sagitalnem sinusu (glejte poglavje 5.2).
The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
Nosečnost Zdravnik nuklearne medicine vam bo to zdravilo med nosečnostjo dal samo, če pričakovane koristi odtehtajo tveganja.
BAPL score
Ocena BAPL
Florbetaben (18F) is highly bound to plasma proteins (>98.5%).
[18F]florbetaben se v veliki meri veže na proteine v plazmi (>98,5 %).
The maximum dose should not exceed 360 MBq and not fall below 240 MBq at time of administration.
360 MBq niti ne sme pasti pod 240 MBq ob času dajanja.
Dose absorbed per activity administered [mGy/MBq]
Absorbiran odmerek na enoto dane aktivnosti [mGy/MBq]
Note: For a score of tracer uptake in the cortex, the finding should have been present in the majority of the slices within the region in question.
Opomba: Za oceno privzema označevalca v skorji mora biti ugotovitev potrjena v večini režnjev znotraj zadevne regije.
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Zdravnik nuklearne medicine vam bo povedal, kako dolgo ponavadi traja postopek.
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
S tem radiofarmakom prejmete majhne količine ionizirajočega sevanja, povezanega z najmanjšim tveganjem za razvoj raka in dednih nenormalnosti.
A subject is classified as “positive” or “negative” based on the brain amyloid plaque load (BAPL) score (Table 2) which is derived from RCTU scores in the four brain regions (Table 1).
Preiskovanec je klasificiran kot "pozitiven" ali "negativen" na osnovi ocene odlaganja amiloidnih leh v možganih (brain amyloid plaque loadBAPL) (Tabela 2), ki je izpeljana iz ocen RCTU v štirih regijah v možganih (Tabela 1).
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.
The complete SmPC of Neuraceq is provided as a separate document in the 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 Neuraceq 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 dajanju in uporabi tega radiofarmaka.
Based on in vitro investigations florbetaben (18F) is metabolised predominantly by CYP2J2 and CYP4F2.
Na podlagi preiskav in vitro se [18F]florbetaben presnavlja predvsem s CYP2J2 in CYP4F2.
Seibersdorf Labor GmbH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf Austria
Seibersdorf Labor GmbH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf Avstrija
Condition for assessment
Pogoj za ovrednotenje
The activity of florbetaben (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.
Aktivnost [18F]florbetabena je treba izmeriti z merilnikom aktivnosti (kalibratorjem odmerka) tik pred injiciranjem.
The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity.
Odčitovalec mora primerjati intenzivnost signala kortikalne sive možganovine z maksimalno intenzivnostjo signala bele možganovine.
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Pri teh bolnikih je treba skrbno pretehtati razmerje med koristmi in tveganji, saj je mogoča večja izpostavljenost sevanju.
Cortical SUV ratios (SUVRs, relative to cerebellar cortex) are higher in AD patients compared with those of healthy volunteer subjects.
Kortikalna razmerja SUV (SUVR, glede na cerebelarno skorjo) so višja pri bolnikih z AB kot pri zdravih prostovoljcih.
Table 1: Definitions of regional cortical tracer uptake (RCTU) RCTU score
Tabela 1: Definicije regionalnega kortikalnega privzema označevalca (regional cortical tracer uptake - RCTU) Ocena regionalnega kortikalnega privzema označevalca
Pack size of 1 vial.
Velikost pakiranja je 1 viala.
Sensitivity and specificity to estimate beta-amyloid deposition of florbetaben (18F) was further investigated in one additional study, in which a different set of 5 electronically-trained blinded readers interpreted images from 54 subjects followed to autopsy in the pivotal study.
Občutljivost in specifičnost [18F]florbetabena za ugotavljanje ß-amiloidnega odlaganja so nadalje preiskovali v dodatni študiji, pri kateri je druga skupina petih elektronsko usposobljenih odčitovalcev interpretirala slike 54 preiskovancev, ki so jim v ključni študiji sledili do obdukcije.
Neuraceq has no influence on the ability to drive and use machines.
Zdravilo Neuraceq nima vpliva na sposobnost vožnje in upravljanja strojev.
<Justification for not including Braille accepted>
<Sprejeta je utemeljitev, da Braillova pisava ni potrebna.>
The efficacy of florbetaben (18F) for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Učinkovitost [18F]florbetabena pri napovedovanju razvoja AB ali spremljanju odziva na zdravljenje ni bila ugotovljena (glejte poglavje 5.1).
Tracer uptake (i.e., signal intensity) in grey matter in the region is lower than in white matter.
Privzem označevalca (to je intenzivnost signala) v sivi možganovini v regiji je manjši kot v beli možganovini.
A Neuraceq PET scan, along with other brain function tests, can help your doctor determine whether or not you may have β-amyloid plaques in your brain.
PET-preiskava z zdravilom Neuraceq, skupaj z drugimi testi delovanja možganov, lahko vašemu zdravniku pomaga ugotoviti, ali imate v možganih β amiloidne lehe.
Contents of the pack and other information What Neuraceq contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Neuraceq
Due to the small quantity of florbetaben (18F) in each dose, overdose is not expected to result in pharmacological effects.
Zaradi majhne količine [18F]florbetabena v posameznem odmerku ni pričakovati, da bi imelo preveliko odmerjanje farmakološke učinke.
Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU United Kingdom
Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU Velika Britanija
Table 4: Estimated radiation absorbed doses from intravenous injection of Neuraceq to Caucasian subjects
Tabela 4: Ocenjeni odmerki absorbiranega sevanja od intravenske injekcije z zdravilom Neuraceq pri preiskovancih kavkaške rase
Common (may affect up to 1 in 10 people): - Injection site reactions: injection site pain, redness of the skin at injection site (injection /
pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - reakcije na mestu injiciranja: bolečina na mestu injiciranja, pordelost kože na mestu injiciranja
Feeling hot
Pekoč občutek
Interpretation of the images is made visually comparing the activity in cortical grey matter with activity in adjacent cortical white matter.
Interpretacija slik temelji na vizualnem pregledu, tako da se primerjata aktivnost v kortikalni sivi možganovini in aktivnost v sosednji kortikalni beli možganovini.