FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of EndolucinBeta have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene proizvoda EndolucinBeta nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: EndolucinBeta received a marketing authorisation valid throughout the EU on 6 July 2016.
Croatian: EndolucinBeta dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 6. srpnja
English: Radiolabelling with EndolucinBeta takes place in a laboratory.
Croatian: Radioaktivno označavanje proizvodom EndolucinBeta obavlja se u laboratoriju.
English: As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from EndolucinBeta.
Croatian: Kao i u slučaju svih materijala za radioaktivno označavanje za lijekove, postoje rizici povezani s izlaganjem zračenju proizvoda EndolucinBeta.
English: Other information about EndolucinBeta
Croatian: Ostale informacije o proizvodu EndolucinBeta
English: The active substance in EndolucinBeta, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation.
Croatian: Djelatna tvar proizvoda EndolucinBeta, lutecijev (177Lu) klorid, radioaktivni je spoj koji uglavnom otpušta beta zračenje, s malom količinom gama zračenja.
English: EndolucinBeta is only used by specialists who have experience in radiolabelling.
Croatian: EndolucinBeta smiju primjenjivati samo specijalisti s iskustvom u radioaktivnom označavanju.
English: Information on how to minimise the risks is included in the product information for EndolucinBeta.
Croatian: Informacije o tome kako minimizirati rizike sadržane su u informacijama o lijeku za EndolucinBeta.
English: What is EndolucinBeta and what is it used for?
Croatian: Što je EndolucinBeta i za što se primjenjuje?
English: Why is EndolucinBeta authorised in the EU?
Croatian: Zašto je EndolucinBeta odobren u EU-u?
English: An overview of EndolucinBeta and why it is authorised in the EU
Croatian: Pregled informacija o proizvodu EndolucinBeta i zašto je odobren u EU-u
English: The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well documented in the scientific literature.
Croatian: Europska agencija za lijekove zaključila je da je primjena lutecija (177Lu) za radioaktivno označavanje lijekova dobro dokumentirana u znanstvenoj literaturi.
English: EndolucinBeta is never given to a patient on its own.
Croatian: EndolucinBeta se bolesnicima nikada ne daje kao monoterapija.
English: The side effects with EndolucinBeta depend largely on the medicine it is used with and are described in that medicine's package leaflet.
Croatian: Nuspojave proizvoda EndolucinBeta u velikoj mjeri ovise o lijeku s kojim se primjenjuje i opisane su u uputi o lijeku za dotični lijek.
English: How well EndolucinBeta works will largely depend on the medicine that it is used to radiolabel.
Croatian: Kako dobro djeluje EndolucinBeta uvelike će ovisiti o lijeku koji se koristi za radioaktivno označavanje.
English: EndolucinBeta is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Croatian: EndolucinBeta se upotrebljava za radioaktivno označavanje lijekova koji su posebno razvijeni za primjenu s lutecijevim (177Lu) kloridom.
English: What are the risks associated with EndolucinBeta?
Croatian: Koji su rizici povezani s proizvodom EndolucinBeta?
English: The Agency concluded that the benefits of EndolucinBeta outweigh the risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od proizvoda EndolucinBeta nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
English: As for all medicines, data on the use of EndolucinBeta are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni proizvoda EndolucinBeta kontinuirano se prate.
English: Information on restrictions that apply specifically to medicines radiolabelled with EndolucinBeta can be found in the package leaflets of those medicines.
Croatian: Informacije o ograničenjima koja se primjenjuju na lijekove radioaktivno označene proizvodom EndolucinBeta navedene su u uputi o lijeku za te lijekove.
English: EndolucinBeta contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines.
Croatian: EndolucinBeta sadrži radioaktivni spoj lutecijev (177Lu) klorid i primjenjuje se za radioaktivno označavanje drugih lijekova.
English: How does EndolucinBeta work?
Croatian: Kako djeluje EndolucinBeta?
English: What benefits of EndolucinBeta have been shown in studies?
Croatian: Koje su koristi od proizvoda EndolucinBeta utvrđene u ispitivanjima?
English: For the list of all side effects and restrictions with EndolucinBeta, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni proizvoda EndolucinBeta potražite u uputi o lijeku.
English: How is EndolucinBeta used?
Croatian: Kako se EndolucinBeta primjenjuje?
English: Lu) chloride)
Croatian: EndolucinBeta (lutecijev (177Lu) klorid)
English: Activity in the brain is low.
Croatian: Aktivnost u mozgu je niska.
English: Date of first authorisation: 22 May 2017
Croatian: Datum prvog odobrenja: 22. svibnja 2017.
English: It will be the smallest quantity necessary to get the desired information.
Croatian: To će biti najmanja potrebna količinu za dobivanje željenih informacija.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in sections 6.6 and 12.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6 i 12.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Croatian: Ipak, u slučaju predoziranja, primit ćete odgovarajuće liječenje.
English: Axumin will only be used in specially controlled areas.
Croatian: Axumin će se koristiti samo u posebno kontroliranim područjima.
English: Histopathology standard of truth data was available for 99 of the 115 subjects.
Croatian: Podaci histopatološkog standarda istine bili su dostupni za 99 od 115 ispitanika.
English: It might be helpful to estimate the effective dose that was applied.
Croatian: Bilo bi korisno procijeniti efektivnu dozu koja je primijenjena.
English: Blinded reads were compared with the histopathological standard of truth.
Croatian: Slijepa očitavanja uspoređena su s histopatološkim standardom istine.
English: One injection is usually sufficient to conduct the test that your doctor needs.
Croatian: Jedna injekcija obično je dovoljna za pretragu koja je potrebna Vašem liječniku.
English: Axumin is not intended for use in children and adolescents aged under 18 years.
Croatian: Axumin nije namijenjen za primjenu kod djece i adolescenata mlađih od 18 godina.
English: The Healthcare professionals self-training material shall contain the following key elements:
Croatian: Materijal za samostalnu obuku zdravstvenih radnika sadržavat će sljedeće ključne elemente:
English: Patients with non-surgical therapy were treated at least 2 years before.
Croatian: Bolesnici s nekirurškim liječenjem bili su liječeni najmanje 2 godine prije.
English: radioactive
Croatian: radioaktivno
English: The major route of elimination is via the renal pathway.
Croatian: Glavni put eliminacije je putem bubrega.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Croatian: Njihovo preuzimanje, čuvanje, primjena, prijenos i zbrinjavanje podložni su propisima i/ili odgovarajućim dozvolama nadležnog službenog tijela.
English: You should discuss the results of the test with the doctor that requested the scan.
Croatian: Rezultate testa trebate raspraviti s liječnikom koji je zatražio snimku.
English: Long-term carcinogenicity studies have not been carried out.
Croatian: Nisu provedena dugoročna ispitivanja kancerogenosti.
English: Appropriate aseptic precautions should be taken.
Croatian: Potrebno je poduzeti odgovarajuće aseptičke mjere opreza.
English: Effective dose
Croatian: Efektivna doza
English: From a microbiological point of view, unless the method of opening/ dose withdrawal/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, osim ako metoda otvaranja/uzimanja doze/razrjeđivanja isključuje rizik od mikrobiološke kontaminacije, lijek se mora primijeniti odmah.
English: Washout of activity from most organs and tissues (with the exception of the pancreas) is slow.
Croatian: Eliminacija aktivnosti iz većine organa i tkiva (izuzev gušterače) je spora.
English: Increasing the duration of acquisition over the pelvis may increase the sensitivity of detection of disease.
Croatian: Povećavanje vremena snimanja preko zdjelice može povećati osjetljivost detekcije bolesti.
English: Contents of the pack and other information What Axumin contains
Croatian: Sadržaj pakiranja i druge informacije Što Axumin sadrži
English: The patient should be positioned supine with arms above the head.
Croatian: Bolesnika treba postaviti u ležeći položaj na leđima s rukama iznad glave.
English: - not eat or drink for at least 4 hours before the scan (you can take your usual medicines with small amounts of water).
Croatian: - ne jesti niti piti najmanje 4 sata prije snimanja (možete uzeti uobičajene lijekove uz malu količinu vode).
English: The nuclear medicine doctor supervising the procedure will decide on the quantity of Axumin to be used in your case.
Croatian: Liječnik specijalist nuklearne medicine koji nadgleda postupak odlučit će o količini lijeka Axumin koja će se koristiti u Vašem slučaju.
English: Urinary excretion is slow, reaching approximately 3% of administered radioactivity within 4 hours and 5% within 24 hours.
Croatian: Izlučivanje urinom odvija se sporo, a dostiže približno 3% primijenjene radioaktivnosti u roku od 4 sata odnosno 5% u roku od 24 sata.
English: - Pain or rash at the site of injection, altered taste in the mouth, altered sense of smell.
Croatian: - Bol ili osip na mjestu injekcije, izmijenjen okus u ustima, izmijenjen osjet njuha.
English: The nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine.
Croatian: Liječnik specijalist nuklearne medicine obavijestit će Vas trebate li poduzeti neke druge posebne mjere opreza nakon primanja ovog lijeka.
English: Histological assessment of extraprostatic sites (either regional lymph nodes or distant sites) was only conducted for sites with positive image findings.
Croatian: Histopatološka procjena izvanprostatičnih mjesta (bilo regionalnih limfnih čvorova ili udaljenih mjesta) bila je provedena samo za snimke mjesta s pozitivnim nalazom.
English: Typical total scan time is between 20-30 minutes.
Croatian: Ukupno trajanje snimanja uobičajeno iznosi između 20 i 30 minuta.
English: The recommended maximum volume of injection of undiluted Axumin is 5 mL.
Croatian: Preporučen maksimalni volumen injekcije nerazrijeđenog lijeka Axumin je 5 ml.
English: Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway.
Croatian: Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norveška.
English: For the limitations in the interpretation of a positive scan, see section 4.4 and 5.1.
Croatian: Za ograničenja u tumačenju pozitivnog nalaza snimanja, pogledajte dijelove 4.4 i 5.1.
English: 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.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove jer to može utjecati na tumačenje snimki.
English: Exp{hh:mm}{Time Zone}{DD/MM/YYYY}
Croatian: Exp{hh:mm}{vremenska zona}{DD/MM/GGGG}
English: 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).
Croatian: Prije primjene fluciklovina (18F), bolesnici ne smiju jesti niti piti najmanje 4 sata (osim malih količina vode za uzimanje lijekova).
English: Other medicines and Axumin
Croatian: Drugi lijekovi i Axumin
English: The MAH shall ensure that in each Member State where Axumin is marketed, all Healthcare professionals who are expected to use Axumin have access to self-training educational material in order to reduce the risk of PET imaging interpretation errors.
Croatian: Nositelj odobrenja će osigurati da, u svakoj državi članici gdje je Axumin na tržištu, svi zdravstveni radnici od kojih se očekuje da će koristiti Axumin imaju pristup edukacijskom materijalu za samostalnu obuku kako bi umanjili opasnost od pogrešaka u tumačenju PET snimki.
English: The scan will usually start approximately 5 minutes after the Axumin injection is given.
Croatian: Snimanje obično započinje približno 5 minuta nakon injekcije lijeka Axumin.
English: With increasing time post injection, distributed uptake is apparent and is mostly associated with skeletal muscle.
Croatian: S povećanjem vremena nakon injekcije vidljivo je distribuirano nakupljanje, a najviše je povezano uz skeletne mišiće.
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: To treba uzeti u obzir ako ste na dijeti s kontroliranim unosom natrija.
English: Values were calculated from human biodistribution data using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software.
Croatian: Vrijednosti su izračunate na temelju podataka o biodistribuciji u ljudi primjenom softvera OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Croatian: Kod svakog bolesnika izlaganje zračenju mora biti opravdano očekivanom koristi.
English: This medicinal product is not intended for regular or continuous administration.
Croatian: Ovaj lijek nije namijenjen redovitoj ili kontinuiranoj primjeni.
English: Individual benefit/risk justification
Croatian: Opravdanost koristi/rizika za pojedinog bolesnika
English: - if you are allergic to fluciclovine (18F) or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na fluciklovin (18F) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: It is considered unlikely that Axumin will affect your ability to drive or to use machines.
Croatian: Smatra se malo vjerojatnim da će Axumin utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud France
Croatian: Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud Francuska
English: It should be recommended to the patient that they do not undertake any significant exercise for at least a day before the fluciclovine (18F) scan.
Croatian: Potrebno je savjetovati bolesnika da ne poduzima nikakvo značajno vježbanje najmanje jedan dan prije snimanja s fluciklovinom (18F).
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Radiofarmaceutici se moraju pripremati na način koji zadovoljava i sigurnost od zračenja i zahtjeve farmaceutske kvalitete.
English: The solution should be inspected visually prior to use.
Croatian: Otopinu treba vizualno pregledati prije upotrebe.
English: Parcelas 1 y 2 La Almunia de Doña Godina 50100 Zaragoza
Croatian: Polígono Industrial La Cuesta-Sector 3. Parcelas 1 y 2 La Almunia de Doña Godina 50100 Zaragoza
English: - avoid exercise for at least a day before the Axumin scan.
Croatian: - izbjegavati vježbanje najmanje jedan dan prije snimanja s lijekom Axumin.
English: A CT scan should be obtained for attenuation correction and anatomic correlation.
Croatian: Potrebno je napraviti snimku CT-om radi korekcije atenuacije i anatomske korelacije.
English: Fluciclovine is not metabolised in vivo.
Croatian: Fluciklovin se ne metabolizira in vivo.
English: As a result of the manufacturing process some vials are distributed with punctured rubber stoppers.
Croatian: Kao rezultat proizvodnog postupka, neke se bočice distribuiraju s probušenim gumenim čepovima.
English: The following side effects of Axumin are common (may affect up to 1 in 100 people).
Croatian: Sljedeće nuspojave lijeka Axumin su česte (mogu se javiti u do 1 na 100 osoba):
English: Fluciclovine is not incorporated into proteins.
Croatian: Fluciklovin se ne ugrađuje u proteine.
English: What Axumin looks like and contents of the pack
Croatian: Kako Axumin izgleda i sadržaj pakiranja
English: Adverse reactions were reported commonly (≥ 1/100 to < 1/10) during clinical trials.
Croatian: Nuspojave su prijavljivane često (≤1/100 do <1/10 bolesnika) tijekom kliničkih ispitivanja.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc.
Croatian: Primjena radiofarmaceutika predstavlja rizik za druge osobe zbog vanjskog zračenja ili kontaminacije od prolijevanja urina, povraćenog sadržaja i slično.
English: Exp: ToC + 8h
Croatian: Rok valjanosti: ToC + 8h
English: DATE OF REVISION OF THE TEXT 11.
Croatian: DATUM REVIZIJE TEKSTA
English: N True positive n (%) False positive n (%) True negative n (%) False negative n (%) Sensitivity [95% CI] Specificity [95% CI] Positive likelihood ratio [95% CI] Negative likelihood ratio [95% CI]
Croatian: N Istinski pozitivna n (%) Lažno pozitivna n (%) Istinski negativna n (%) Lažno negativna n (%) Osjetljivost [95% CI] Specifičnost [95% CI] Omjer vjerojatnosti pozitivnog rezultata [95% CI] Omjer vjerojatnosti negativnog rezultata [95% CI]
English: In addition, fluciclovine uptake may be increased by an inflammatory reaction to recent radiotherapy or cryotherapy.
Croatian: Nadalje, nakupljanje fluciklovina može biti povećano uslijed upalne reakcije na nedavnu radioterapiju ili krioterapiju.
English: 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.
Croatian: Nakupljanje u tumorima odvija se brzo, s najvišim kontrastom između tumora i okolnog normalnog tkiva između 4 i 10 minuta nakon injekcije, što traje približno 30 minuta, a 61%tno smanjenje srednje vrijednosti nakupljanja u tumoru nastupa 90 minuta nakon injekcije.
English: 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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Axumin u jednoj ili više podskupina pedijatrijske populacije u dijagnosticiranju metabolizma aminokiselina u solidnih tumora (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This medicine is not indicated for use in women.
Croatian: Ovaj lijek nije namijenjen za primjenu u žena.
English: The use of Axumin does involve exposure to small amounts of radioactivity.
Croatian: Primjena lijeka Axumin uključuje izlaganje malim količinama radioaktivnosti.
English: Only clear solutions, free of visible particles should be used.
Croatian: Smije se koristiti samo bistra otopina bez vidljivih čestica.
English: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria.
Croatian: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austrija.
English: 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.
Croatian: Kompletan sažetak opisa svojstava lijeka Axumin nalazi se u obliku zasebnog dokumenta u pakiranju lijeka, s ciljem pružanja drugih dodatnih znanstvenih i praktičnih informacija o primjeni i uporabi ovog radiofarmaceutika zdravstvenim radnicima.
English: 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.
Croatian: Bolesnika treba poticati da pije dovoljne količine tekućine i da mokri što češće tijekom prvih sati nakon snimanja kako bi smanjio izloženost mjehura zračenju.
English: Withdrawals should be performed under aseptic conditions.
Croatian: Uzimanje doza treba obavljati u aseptičkim uvjetima.
English: 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.
Croatian: Bočica se ne smije otvarati prije dezinficiranja čepa, otopinu treba povući kroz čep korištenjem jednodozne štrcaljke opremljene odgovarajućim štitnikom i sterilnom iglom za jednokratnu upotrebu ili primjenom odobrenog automatskog sustava primjene.
English: Talk to your nuclear medicine doctor before you are given Axumin if you: - have kidney problems - are on a low sodium diet (see section "Axumin contains sodium").
Croatian: Obratite se svom liječniku specijalisti nuklearne medicine prije nego primite Axumin: - ako imate problema s bubrezima - ako ste na dijeti s ograničenim unosom natrija (vidjeti dio „Axumin sadrži natrij“).
English: If you have been given more Axumin than you should
Croatian: Ako primite više lijeka Axumin nego što ste trebali
English: No. subjects in analysis
Croatian: Br. ispitanika u analizi
English: 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.
Croatian: Prije stavljanja lijeka Axumin u promet u svakoj državi članici, nositelj odobrenja mora dogovoriti oblik i sadržaj edukacijskog programa s nadležnim državnim tijelom.
English: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf AUSTRIA
Croatian: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf AUSTRIJA
English: It is recommended that image acquisition should start from mid-thigh and proceed to the base of the skull.
Croatian: Preporučuje se započeti snimanje od sredine bedara i nastaviti do dna lubanje.
English: 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.
Croatian: Ako ste se prethodno liječili zbog raka prostate i informacije dobivene drugim pretragama (npr. antigen specifičan za prostatu, PSA) ukazuju na mogućnost povratka karcinoma, PET snimanje s lijekom Axumin može pomoći Vašem liječniku u pronalasku mjesta gdje se karcinom ponovno pojavio.
English: Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
Croatian: Potrebno je izbjegavati bliski kontakt s malom djecom i trudnicama tijekom prvih 12 sati nakon injekcije.
English: Exp: ToC + 10h
Croatian: Rok valjanosti: ToC + 10h
English: This medicine contains up to 39 mg sodium per dose.
Croatian: Ovaj lijek sadrži do 39 mg natrija po dozi.
English: Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Croatian: Vaš liječnik i liječnik specijalist nuklearne medicine smatraju da je klinička korist ovog postupka s primjenom radiofarmaceutika veća od rizika izlaganja malim količinama zračenja.