natgillin/translations-raw huggingface dataset:
The patient should be encouraged to drink sufficient amounts and void as often as possible during the first hours after the scan in order to reduce radiation exposure of the bladder.
Bolnika je treba spodbujati k pitju zadostnih količin tekočine in čim pogostejšem odvajanju v prvih urah po slikanju, da se zmanjša izpostavljenost sečnega mehurja sevanju.
Prior to administration of fluciclovine (18F), patients should not eat or drink for at least 4 hours (other than small amounts of water for taking medicinal products).
Pred aplikacijo [18F]fluciklovina bolniki ne smejo jesti ali piti vsaj 4 ure (razen majhne količine vode ob jemanju zdravil).
Blinded reads were compared with the histopathological standard of truth.
Slepe razlage so primerjali s histopatološkimi izvidi, določenimi kot standard resnice.
The nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine.
Specialist nuklearne medicine vas bo obvestil, če boste morali po prejemu tega zdravila uporabiti kakršne koli druge posebne previdnostne ukrepe.
You should discuss the results of the test with the doctor that requested the scan.
O rezultatih preiskave se morate pogovoriti z zdravnikom, ki je zahteval pregled.
This medicine will only be handled and given to you by people who are trained and qualified to use it safely.
Z njim bodo ravnali in vam ga dajali samo strokovnjaki, ki so usposobljeni za njegovo varno uporabo.
Uptake by tumours is rapid, with the highest tumour-to-normal tissue contrast between 4 and 10 minutes after injection and continuing for around 30 minutes, with a 61% reduction in mean tumour uptake at 90 minutes after injection.
Privzem v tumorje je hiter, z največjim kontrastom med tumorskim in normalnim tkivom od 4 do 10 minut po injiciranju, in se nadaljuje približno 30 minut, z 61-odstotnim zmanjšanjem povprečnega privzema v tumor 90 minut po injiciranju.
The use of Axumin does involve exposure to small amounts of radioactivity.
Uporaba zdravila Axumin vključuje izpostavljenost majhni količini radioaktivnosti.
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.
Obvestite specialista za nuklearno medicino, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, saj lahko vpliva na razlago slik.
Quality control
Preverjanje kakovosti
The recommended maximum volume of injection of undiluted Axumin is 5 mL.
Največja priporočena količina nerazredčenega zdravila Axumin v injekciji je 5 ml.
GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL UK
GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL Velika Britanija
Mean absorbed dose per unit administered activity (µGy/MBq)
Povprečni absorbirani odmerek na enoto aplicirane aktivnosti (µGy/MBq)
The following side effects of Axumin are common (may affect up to 1 in 100 people).
Naslednji neželeni učinki zdravila Axumin so pogosti (pojavijo se lahko pri največ 1 od 100
Only clear solutions, free of visible particles should be used.
Uporabiti se smejo samo bistre raztopine brez vidnih delcev.
If at any time in the preparation of this medicinal product the integrity of the vial is compromised it should not be used.
Če je kadar koli med pripravo tega zdravila celovitost viale ogrožena, se viala ne sme uporabiti.
Fluciclovine is not incorporated into proteins.
Fluciklovin se ne vgradi v proteine.
Exp{hh:mm}{Time Zone}{DD/MM/YYYY}
Exp{hh:mm}{časovni pas}{DD/MM/LLLL}
The European Medicines Agency has deferred the obligation to submit the results of studies with Axumin in one or more subsets of the paediatric population in diagnosis of amino acid metabolism in solid tumours (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Axumin za eno ali več podskupin pediatrične populacije pri diagnosticiranju presnove aminokislin pri solidnih tumorjih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Washout of 18F activity from the blood is such that about half of the maximum 18F concentration in blood is reached by about 1 hour after administration.
Izpiranje aktivnosti 18F iz krvi je takšno, da je približno polovica največje koncentracije 18F v krvi dosežena približno 1 uro po dajanju.
A CT scan should be obtained for attenuation correction and anatomic correlation.
Izdelati je treba sliko CT za popravek oslabitve in anatomsko korelacijo.
Axumin must not be used after the expiry date which is stated on the shield label after Exp.
Zdravila Axumin ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ščitniku poleg oznake »Exp«.
- if you are allergic to fluciclovine (18F) or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na [18F]fluciklovin ali katero koli sestavino tega zdravila (navedeno v poglavju
The scan will usually start approximately 5 minutes after the Axumin injection is given.
Slikanje se navadno opravi približno 5 minut po injiciranju zdravila Axumin.
Any unused material should be disposed of in accordance with local requirements.
Neuporabljen material je treba odstraniti skladno z lokalnimi predpisi.
As a result of the manufacturing process some vials are distributed with punctured rubber stoppers.
Zaradi postopka izdelave imajo nekatere viale na trgu predrte gumijaste zamaške.
In addition, fluciclovine uptake may be increased by an inflammatory reaction to recent radiotherapy or cryotherapy.
Poleg tega se lahko privzem fluciklovina poveča zaradi vnetne reakcije na nedavno obsevanje ali krioterapijo.
Toxicological studies with rats and dogs have demonstrated that with a single intravenous injection no deaths were observed.
V toksikoloških študijah pri podganah in psih ni bilo po posamezni intravenski injekciji nobenega smrtnega primera.
Axumin is a clear, colourless solution stored in a glass vial.
Zdravilo Axumin je bistra, brezbarvna raztopina, shranjena v stekleni viali.
The complete SmPC of Axumin is provided as a separate document in the package of the medicinal product, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Celoten povzetek glavnih značilnosti zdravila Axumin, ki je na voljo kot ločen dokument v pakiranju izdelka, zagotavlja zdravstvenim delavcem dodatne znanstvene in praktične informacije o dajanju in uporabi tega radiofarmaka.
The quantity to be administered usually recommended for an adult is 370 MBq (megabecquerel, the unit used to express radioactivity).
Količina, ki se običajno priporoča za odrasle, je 370 MBq (megabekerel je enota, ki se uporablja za izražanje radioaktivnosti).
A quantitative correlation between fluciclovine uptake and enhanced fluciclovine influx into cells was not assessed in vivo in healthy volunteers or prostate cancer patients.
Kvantitativna korelacija med privzemom fluciklovina in povečanim dotokom fluciklovina v celice ni bila ocenjena in vivo pri zdravih prostovoljcih ali bolnikih z rakom prostate.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Radiofarmake je treba pripraviti na način, ki zadošča zaščiti pred sevanjem in zahtevam za farmacevtsko kakovost.
As the effective dose is 8.2 mSv when the maximal recommended activity of 370 MBq is administered these adverse reactions are expected to occur with a low probability.
Ker je efektivni odmerek 8,2 mSv pri uporabi največje priporočene aktivnosti 370 MBq, je pojavnost neželenih učinkov malo verjetna.
For detection of extraprostatic recurrences (regional lymph node and/or distal metastases) sensitivity was 84.2% (32/38) (95%CI: 68.7-94%) and specificity was 89.7% (78/87) (95%CI: 81.3-95.2%), respectively.
Pri odkrivanju ponovitev zunaj prostate (regionalne bezgavke in/ali oddaljene metastaze) je bila občutljivost 84,2 % (32/38) (95 % IZ: 68,7-94 %) in specifičnost 89,7 % (78/87) (95 % IZ: 81,3-95,2 %).
The pivotal efficacy data derives from 115 patients recruited into the BED-001 study at Emory
Ključni podatki o učinkovitosti temeljijo na 115 bolnikih, ki so sodelovali v študiji BED-001 na Univerzi Emory.
Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
prenos in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja pristojnega urada.
This medicine contains up to 39 mg sodium per dose.
To zdravilo vsebuje do 39 mg natrija na odmerek.
If you have previously had treatment for prostate cancer and information from other tests (e.g. prostate specific antigen, PSA) indicates that the cancer may have returned, an Axumin PET scan can help your doctor find the locations where the cancer has come back.
Če ste se v preteklosti že zdravili zaradi raka na prostati in podatki iz drugih preiskav (npr. prostatičnega specifičnega antigena, PSA) kažejo, da se je rak morda vrnil, lahko pozitronska emisijska tomografija z zdravilom Axumin pomaga zdravniku najti mesta, kjer se je rak ponovil.
An overdose is unlikely because you will only receive a single dose of Axumin precisely controlled by the nuclear medicine doctor supervising the procedure.
Prevelik odmerek ni verjeten, saj boste prejeli samo en odmerek zdravila Axumin, ki ga bo odgovorni specialist nuklearne medicine natančno nadzoroval.
With increasing time post injection, distributed uptake is apparent and is mostly associated with skeletal muscle.
Po injekciji sčasoma postane očiten porazdeljen privzem, večinoma v skeletne mišice.
They are listed below by MedDRA body system organ class.
Ti so navedeni spodaj, razvrščeni po organskih sistemih skladno z MedDRA.
Each mL of solution contains 7.7 mg of sodium.
En ml raztopine vsebuje 7,7 mg natrija.
No. subjects in analysis
Št. preiskovancev v analizi
Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf AUSTRIA
Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG Forschungszentrum 2444 Seibersdorf AVSTRIJA
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Ta radiofarmak dovede majhne količine ionizirajočega sevanja, povezanega z najmanjšim tveganjem za nastanek raka in dednih anomalij.
Toxicity with repeated administration of up to 1000 mcg/kg/day over 14 days in rats and dogs was not observed.
Pri 14-dnevnem dajanju ponavljajočih odmerkov do 1000 mcg/kg/dan podganam in psom niso opazili toksičnosti.
Axumin has no or negligible influence on the ability to drive and use machines.
Zdravilo Axumin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
The impact of anti-mitotic agents and colony stimulating factors on uptake of fluciclovine in patients with prostate cancer has not been studied.
Vpliv antimitotskih učinkovin in kolonije spodbujajočih faktorjev na privzem fluciklovina pri bolnikih z rakom prostate ni bil raziskan.
Patient based
Na podlagi bolnika
The activities of LAT-1 and ASCT2 are known to be upregulated in prostate cancer, providing a mechanism for the enhanced accumulation of fluciclovine (18F) in prostate cancer.
Znano je, da je aktivnost LAT-1 in ASCT2 povečana pri raku prostate, kar zagotavlja mehanizem za večje kopičenje [18F]fluciklovina pri raku prostate.
Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, should be considered where appropriate.
Kadar je ustrezno, je treba razmisliti o klinični korelaciji, ki lahko vključuje histopatološko oceno domnevnega mesta ponovitve bolezni.
Prior to launch of Axumin in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme with the National Competent Authority.
Pred prihodom zdravila Axumin na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa.
It is recommended that image acquisition should start from mid-thigh and proceed to the base of the skull.
Priporočeno je, da se slikanje začne na sredini stegen in nadaljuje do lobanjskega dna.
In the event of administration of a radiation overdose with fluciclovine (18F) the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis, frequent micturition and defecation.
V primeru prevelikega odmerka sevanja [18F]fluciklovina je treba po možnosti zmanjšati absorbirani odmerek za bolnika s povečanjem odstranjevanja radionuklidov iz telesa s prisilno diurezo, pogostim uriniranjem in odvajanjem blata.
If you have been given more Axumin than you should
Če ste prejeli večji odmerek zdravila Axumin, kot bi smeli
Other medicines and Axumin
Druga zdravila in zdravilo Axumin
Prostate & prostate bed
Prostata in ležišče prostate
- The other ingredients are sodium citrate, concentrated hydrochloric acid, sodium hydroxide, water for injections (see section 2 "Axumin contains sodium")
- Druge sestavine so natrijev citrat, koncentrirana klorovodikova kislina, natrijev hidroksid in voda za injekcije (glejte poglavje 2 »Zdravilo Axumin vsebuje natrij«).
Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
V prvih 12 urah po injiciranju je treba omejiti tesne stike z dojenčki in nosečnicami.
Distant metastases involved distal lymph nodes, soft tissue and bone.
Oddaljene metastaze vključujejo oddaljene bezgavke, mehko tkivo in kosti.
o Physiological distribution of fluciclovine o Image interpretation guidelines o Examples of incidental findings on PET-CT with fluciclovine o Examples of positive and negative findings on PET-CT with fluciclovine o Demonstration cases with image interpretation provided by an expert
o fiziološka porazdelitev fluciklovina, o smernice za razlaganje slik, o primeri naključnih ugotovitev pri slikanju PET-CT s fluciklovinom, o primeri pozitivnih in negativnih ugotovitev pri slikanju PET-CT s fluciklovinom, o ponazoritveni primeri s strokovno interpretacijo posnetkov
Axumin is supplied in a 10 mL or 15 mL type 1 glass vial sealed with a fluoro-coated chlorobutyl, chlorobutyl or bromobutyl rubber closure and aluminium overseal.
Zdravilo Axumin je na voljo v 10 ml ali 15 ml viali iz stekla tipa 1, zaprti s fluoro obloženim klorobutilnim, klorobutilnim ali bromobutilne gumijastim zamaškom in aluminijasto zaporko.
The vial must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Raztopino je treba odvzeti skozi zamašek z uporabo enoodmerne brizge z ustreznim ščitnikom in sterilno iglo za enkratno uporabo ali odobrenega sistema za avtomatizirano aplikacijo.
For an administered activity of 370 MBq the typical radiation doses to the critical organs, pancreas, the cardiac wall and uterine wall are 37.8 mGy, 19.1 mGy and 16.5 mGy, respectively.
Pri aplicirani aktivnosti 370 MBq so značilni odmerki sevanja v kritičnih organih trebušni slinavki, srčni steni in maternični steni 37,8 mGy, 19,1 mGy oziroma 16,5 mGy.
The effective half-life of fluciclovine (18F) equates to the radioactive half-life of fluorine (18F), which is approximately 110 minutes.
Efektivni razpolovni čas [18F]fluciklovina je enak radioaktivnemu razpolovnemu času fluora (18F), ki je približno 110 minut.
No studies on fertility have been performed.
Študij o plodnosti niso izvedli.
False-positive cases have been also described in association with an inflammatory response after cryotherapy and radiation artefacts in patients previously treated with radiotherapy.
Opisali so tudi lažno pozitivne rezultate v povezavi z vnetno reakcijo po krioterapiji in artefakte pri bolnikih, ki so se predhodno zdravili z obsevanjem.
Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le na recept (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Clear, colourless solution.
Bistra in brezbarvna raztopina.
For each patient, the radiation exposure must be justifiable by the likely benefit.
Pri vsakem bolniku mora pričakovana korist upravičiti izpostavljenost sevanju.
Contents of the pack and other information What Axumin contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Axumin
Should you have any further question on the use of Axumin, please ask your nuclear medicine doctor who supervises the procedure.
Če imate dodatna vprašanja o uporabi zdravila Axumin, se posvetujte s specialistom nuklearne medicine, ki nadzoruje postopek.
Fluciclovine (18F) accumulates in prostate cancer and other types of cancer but also in normal tissues and some other prostate pathologies (such as benign prostatic hyperplasia, chronic prostatitis, high grade prostatic intraepithelial hyperplasia).
Privzem v organe [18F]fluciklovin se kopiči pri raku prostate in drugih vrstah raka, a tudi v normalnih tkivih in pri nekaterih drugih patologijah prostate (kot so benigna hiperplazija prostate, kronični prostatitis in prostatična intraepitelijska neoplazija visoke stopnje).
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 facilitate the removal of radioactivity from your body.
zagotovi načine za povečanje izločanja urina in blata, da olajša odstranitev radioaktivnosti iz vašega telesa.
Activity: {YYYY} MBq Volume: {xx.x] mL
Aktivnost: {YYYY} MBq Volumen: {xx,x] mL
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Odmerjeno aktivnost je treba skrbno izbrati, ker pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju.
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc.
Pri uporabi radiofarmakov obstaja tveganje, da bodo druge osebe izpostavljene sevanju ali kontaminaciji zaradi razlitja urina, bruhanja ipd.
The diagnostic performance of fluciclovine (18F) PET-CT for the detection of recurrence overall (at any location), and in 3 different locations (prostate/bed, pelvic lymph nodes, and distant metastases) is shown in Table 1.
Diagnostična uspešnost slikanja PET-CT z [18F]fluciklovinom za odkrivanje splošne ponovitve (na kateri koli lokaciji) ter na 3 različnih lokacijah (prostata/ležišče prostate, medenične bezgavke in oddaljene metastaze) je navedena v preglednici 1.
The impact of quantitative/semiquantitative measurement of fluciclovine (18F) uptake as an aid to image interpretation has not been assessed.
Vpliva kvantitativnega/semikvantitativnega merjenja privzema [18F]fluciklovina kot pripomočka pri razlaganju slik niso ocenili.
What Axumin is and what it is used for 2.
Kaj je zdravilo Axumin in za kaj ga uporabljamo 2.
In in vitro studies, fluciclovine (18F) was not taken up by common drug transporters indicating a negligible potential for drug interactions.
V študijah in vitro običajni prenašalci zdravil niso privzeli [18F]fluciklovina, kar kaže na zanemarljiv potencial za interakcije.
Administration of Axumin and conduct of the procedure
Dajanje zdravila Axumin in potek postopka
Gallbladder wall Lower large intestine wall Small intestine wall Stomach wall Upper large intestine wall Heart wall
Stena zgornjega debelega črevesa Srčna stena
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 preučiti razmerje med koristjo in tveganjem, ker je mogoča povečana izpostavljenost sevanju.
Activity: {YYYY} MBq in {xx.x}mL at {hh:mm}{Time Zone} {DD/MM/YYYY}
Aktivnost: {YYYY} MBq v {xx,x} ml ob {hh:mm}{časovni pas} {DD/MM/LLLL}
Patients were adult and elderly men presenting with suspected recurrence, based on elevated blood PSA levels after primary curative treatment of localized prostate cancer and with negative bone scintigraphy.
Bolniki so bili odrasli in starejši moški s sumom na ponovitev bolezni na podlagi zvišanih krvnih ravni PSA po primarnem kurativnem zdravljenju lokaliziranega raka prostate in z negativno scintigrafijo kosti.
Axumin should be administered as a bolus intravenous injection.
Zdravilo Axumin je treba aplicirati kot intravensko bolus injekcijo.
What you need to know before Axumin is used 3.
Kaj morate vedeti, preden boste uporabili zdravilo Axumin 3.
Excipients: sodium citrate, concentrated hydrochloric acid, sodium hydroxide, and water for injections.
Pomožne snovi: natrijev citrat, koncentrirana klorovodikova kislina, natrijev hidroksid in voda za injekcije.
The estimated absorbed radiation doses for adult patients following intravenous injection of fluciclovine (18F) are shown in Table 3.
Ocenjeni absorbirani odmerki sevanja za odrasle bolnike po intravenski injekciji [18F]fluciklovina so prikazani v preglednici 3.
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Za uporabo, ravnanje z radiofarmaki in njihovo odlaganje veljajo strogi zakoni.
Patients with non-surgical therapy were treated at least 2 years before.
Bolniki, ki so bili deležni nekirurškega zdravljenja, so se zdravili najmanj
Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Shranjevanje radiofarmacevtskih izdelkov bo skladno z lokalnimi predpisi o radioaktivnih snoveh.
Diagnostic performance of fluciclovine (18F) to detect recurrences has not been investigated in patients with a suspected recurrence based on elevated blood PSA levels after primary radical treatment with a recent positive whole-body bone scintigraphy.
Diagnostične učinkovitosti [18F]fluciklovina pri odkrivanju ponovitev niso raziskali pri bolnikih s sumom ponovitve na podlagi zvišanih krvnih ravni PSA po primarnem radikalnem zdravljenju z nedavno pozitivno scintigrafijo kosti po vsem telesu.
The injection should be followed by an intravenous flush of sterile sodium chloride 9 mg/ml (0.9%) solution for injection to ensure full delivery of the dose.
Injekciji mora slediti intravensko izpiranje z 0,9-odstotno (9 mg/ml) sterilno raztopino natrijevega klorida za injiciranje, da se zagotovi dovajanje celotnega odmerka.
The use of either intravenous iodinated CT contrast or oral contrast media is not required to interpret fluciclovine (18F) PET images.
Uporaba intravenskega jodiranega kontrastnega sredstva CT ali peroralnega kontrastnega sredstva ni potrebna za razlago slik PET z [18F]fluciklovinom.
Axumin contains the active ingredient fluciclovine (18F) and is given so that doctors can perform a special type of scan called a PET scan.
Zdravilo Axumin vsebuje učinkovino [18F]fluciklovin in se aplicira bolniku, da lahko zdravniki opravijo posebno vrsto slikanja, ki se imenuje pozitronska emisijska tomografija (PET).
Fluciclovine (18F) is preferentially taken up into prostate cancer cells compared with surrounding normal tissues.
[18F]fluciklovin prednostno privzamejo celice raka prostate v primerjavi z okoliškimi normalnimi tkivi.
- avoid exercise for at least a day before the Axumin scan.
- biti telesno dejavni vsaj en dan pred slikanjem z zdravilom Axumin;
Fluciclovine (18F) is not indicated for use in women.
[18F]fluciklovin ni indiciran za uporabo pri ženskah.
Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
Zdravilo Axumin je indicirano za slikanje s pozitronsko emisijsko tomografijo (PET) za odkrivanje ponovnega pojava raka prostate pri odraslih moških, pri katerih sumimo na ponovitev na podlagi zvišane krvne ravni prostatičnega specifičnega antigena (PSA) po primarnem kurativnem zdravljenju.