FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Croatian: Vaš liječnik i liječnik specijalist nuklearne medicine smatraju da je klinička korist od ovog postupka s primjenom radiofarmaceutika veća od rizika izlaganja zračenju.
English: No dose adjustment is recommended based on age.
Croatian: Ne preporučuje se prilagodba doze ovisna o dobi.
English: Total volume: ________mL
Croatian: Ukupan volumen: ________mL
English: For patient preparation, see section 4.4.
Croatian: Za pripremu bolesnika vidjeti dio 4.4.
English: Before administration of Lymphoseek you should: Follow the instructions of your doctor or nuclear medicine doctor.
Croatian: Prije primjene lijeka Lymphoseek morate: Pridržavati se uputa koje Vam je dao Vaš liječnik ili liječnik specijalist nuklearne medicine.
English: Determination of injection volumes
Croatian: Utvrđivanje volumena injekcije
English: • if you have kidney or liver problems (renal or heptatic disease)
Croatian: • ako imate problema s bubrezima ili jetrom (bolesti bubrega ili jetre)
English: Vials are sealed under nitrogen; air or oxygen is harmful to the contents of the vial and therefore the vial should not be vented.
Croatian: Bočice su zabrtvljene pod dušikom; zrak ili kisik su štetni za sadržaj bočice te se stoga bočica ne smije odzračivati.
English: The quantity to be administered usually recommended for an adult ranges from 18.5 to 74 MBq (megabecquerel, the unit used to express radioactivity).
Croatian: Uobičajena preporučena količina koja se primjenjuje za odrasle je u rasponu od 18,5 do 74 MBq (megabekerel je jedinica kojom se izražava radioaktivnost).
English: Pharmacotherapeutic group: diagnostic radiopharmaceutical, tumour detection, ATC Code: V09IA09.
Croatian: Farmakoterapijska skupina: dijagnostički radiofarmaceutik, otkrivanje tumora, ATK oznaka: V09IA09.
English: The surgeon will also use a machine that finds the 99mTc part of the medicine.
Croatian: Kirurg također koristi uređaj kojim pronalazi 99mTc dio lijeka.
English: Use within the expiry time on the label.
Croatian: Upotrijebite unutar roka trajanja navedenog na naljepnici.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: c. Do not vent the tilmanocept powder vial prior to or during radiolabelling.
Croatian: c. Ne odzračujte bočicu praška tilmanocepta prije ili tijekom radioaktivnog obilježavanja.
English: Patient preparation
Croatian: Priprema bolesnika
English: • irritation or pain where the injection is given (including the breast and skin)
Croatian: • nadraženost ili bol na mjestu primjene injekcije (uključujući dojku i kožu)
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Radiofarmaceutici se moraju pripremiti na način koji zadovoljava i zahtjeve sigurnosti kod zračenja i zahtjeve farmaceutske kvalitete.
English: If you are pregnant, the nuclear medicine doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks.
Croatian: Ako ste trudni, liječnik specijalist nuklearne medicine ovaj će lijek primijeniti tijekom trudnoće isključivo ako se očekuje da će korist biti veća od rizika.
English: Table 4: Example of three-sigma rule threshold Background counta
Croatian: Tablica 4.: Primjeri praga tri sigma pravila Pozadinski broja
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 and 12.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelovima 6.6. i 12. 6.3. Rok valjanosti
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lymphoseek in one or more subsets of the paediatric population for visualisation of lymphatic drainage of solid malignant tumours for diagnostic purposes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Lymphoseek u jednoj ili više podskupina pedijatrijske populacije za vizualizaciju limfatičke drenaže solidnih malignih tumora u dijagnostičke svrhe (vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni).
English: If you are allergic to tilmanocept or any of the other ingredients of this medicine (listed in section 6) or to any of the ingredients of the radiolabelled pharmaceutical.
Croatian: Ako ste alergični na tilmanocept ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ili na bilo koji sastojak radioaktivno obilježenog farmaceutika.
English: Elderly patients aged 65 or older (32%) were evaluated in clinical studies; no safety issues were identified.
Croatian: U kliničkim ispitivanjima ocijenjena je primjena u starijih bolesnika u dobi od 65 godina ili više godina (32%); nisu identificirani sigurnosni problemi.
English: Macrophages are present in high concentrations in lymph nodes.
Croatian: Makrofagi su prisutni u visokim koncentracijama u limfnim čvorovima.
English: In clinical trials with 553 patients, the most common adverse reactions were: ◦ Injection site irritation (0.7%; 4 of 553 patients) ◦ Injection site pain (0.2%; 1 of 553 patients)
Croatian: U kliničkim ispitivanjima koja su uključivala 553 bolesnika, najčešće nuspojave bile su: ◦ nadraženost na mjestu primjene injekcije (0,7%; 4 od 553 bolesnika), ◦ bol na mjestu primjene injekcije (0,2%; 1 od 553 bolesnika).
English: • In clinical studies, patients received Lymphoseek up to 30 hours before surgery.
Croatian: • U kliničkim ispitivanjima, bolesnici primaju lijek Lymphoseek do 30 sati prije kirurškog zahvata.
English: • Keep this leaflet.
Croatian: • Sačuvajte ovu uputu.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Croatian: Primijenjena aktivnost mora u svakom slučaju biti najniža moguća aktivnost koja će osigurati dobivanje potrebnih dijagnostičkih informacija.
English: The dose of 50 micrograms should not be adjusted for body weight differences.
Croatian: Dozu od 50 mikrograma nije potrebno prilagođavati tjelesnoj težini.
English: Radiopharmaceuticals should be used by or under the control of healthcare professionals who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorised to license the use of radionuclides.
Croatian: Radiofarmaceutike smiju primjenjivati ili njihovu primjenu nadgledati samo kvalificirani zdravstveni djelatnici sa specifičnom obukom i iskustvom u sigurnoj primjeni i rukovanju radionuklidima, i čije su iskustvo i obuku odobrile odgovarajuće vladine agencije koje izdaju licence za primjenu radionuklida.
English: 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.
Croatian: Ako postoji sumnja na trudnoću (ako je u žene izostala mjesečnica, ako je mjesečnica neredovita, itd.), bolesnici je potrebno ponuditi druge metode koje ne uključuju primjenu ionizirajućeg zračenja (ako su iste dostupne).
English: For injection after radiolabelling.
Croatian: Za primjenu injekcijom nakon radioaktivnog obilježavanja.
English: For injection
Croatian: Za primjenu injekcijom
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total activity: ________MBq
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Ukupna aktivnost: ________MBq
English: • feeling of warmth, a pricking or tingling sensation, or pain in an extremity, shoulder, the neck or jaw
Croatian: • osjećaj topline, peckanja ili trnaca, ili boli u udovima, ramenima, vratu ili čeljusti
English: Allow the solvent to migrate to the solvent front line (5 cm from the bottom of the Whatman strips and 3.5 cm for the Biodex strip).
Croatian: Ostavite otapalo da migrira do fronte otapala (5 cm od donjeg ruba papira Whatman i 3,5 cm za trakicu Biodex).
English: The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder.
Croatian: Bočica sadrži sterilan, nepirogeni, bijeli do prljavo bijeli liofilizirani prašak.
English: Affix the label to the shield.
Croatian: Zalijepite naljepnicu na zaštitu.
English: Use within 6 hours of radiolabelling.
Croatian: Uporaba u roku od 6 sati nakon radioaktivnog obilježavanja.
English: These rates were significantly greater (p<0.0001) against a random effects meta-analysis of localisation rates from published literature for colloidal lymphatic mapping agents as used in European clinical practice.
Croatian: Ove stope su značajno više (p<0,0001) u usporedbi s podacima iz meta analize stopa lokalizacije metodom nasumičnih učinaka dostupnim u objavljenoj literaturi za koloidna sredstva za limfatičko označavanje koja se primjenjuju u europskoj kliničkoj praksi.
English: If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Croatian: Ako nastupi reakcija preosjetljivosti ili anafilaktička reakcija, potrebno je odmah prekinuti primjenu lijeka i započeti s intravenskim liječenjem ako je potrebno.
English: This means that it is used in breast cancer, melanoma or oral cavity cancers to help find out about your illness.
Croatian: To znači da se koristi u slučaju raka dojke, melanoma ili raka usne šupljine kao pomoć pri prikupljanju informacija o bolesti.
English: Calibration time: ________Time/Date
Croatian: Vrijeme kalibracije: ________ vrijeme / datum 6. DRUGO
English: It is not a treatment for your illness.
Croatian: Ovaj lijek nije namijenjen liječenju bolesti.
English: • The active substance is tilmanocept.
Croatian: • Djelatna tvar je tilmanocept.
English: This medicine is for diagnostic use in adults only.
Croatian: Ovaj lijek se koristi samo u dijagnostičke svrhe u odraslih.
English: • wound pain, wound opening or accumulation of fluid at surgical site
Croatian: • bolna rana, otvaranje rane ili nakupljanje tekućine na mjestu kirurškog zahvata
English: Prior to preparation, determine the planned injection technique and the number of injections that will be used for a given patient.
Croatian: Prije pripreme utvrdite planirani put primjene i broj injekcija koje želite primijeniti pojedinom bolesniku.
English: Exposure to ionizing radiation is linked with cancer induction and a potential for the development of hereditary defects.
Croatian: Izlaganje ionizirajućem zračenju povezano je s nastankom raka i mogućim razvojem nasljednih mana.
English: Based on clinical studies, the rate of localisation (percent of all patients with at least one hot node) and degree of localisation (average number of hot nodes per patient) of Lymphoseek is not dependent on the radiopharmaceutical injection technique.
Croatian: Na temelju kliničkih ispitivanja, stopa lokalizacije (postotak svih bolesnika s najmanje jednim „toplim“ čvorom) i stupanj lokalizacije (prosječan broj „toplih“ čvorova po bolesniku) lijeka Lymphoseek ne ovise o radiofarmaceutskoj tehnici ubrizgavanja.
English: However, after sodium pertechnetate (99mTc) is added, adequate shielding of the final preparation must be maintained.
Croatian: No, nakon dodavanja natrijevog pertehnetata [99mTc] mora se osigurati primjerena zaštita završnog pripravka.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting, etc.
Croatian: Primjena radiofarmaceutika rizična je za druge osobe jer može doći do vanjskog zračenja ili kontaminacije uslijed prolijevanja mokraće, povraćanja itd.
English: Without withdrawing the needle, remove an equal volume of headspace gas.
Croatian: Bez izvlačenja igle izvadite jednaki volumen plina iznad otopine (tzv. headspace plina).
English: You must inform the nuclear medicine doctor before the administration of Lymphoseek if there is a possibility you might be pregnant, if you have missed your period, or if you are breast-feeding.
Croatian: Morate obavijestiti liječnika specijalista nuklearne medicine prije primjene lijeka Lymphoseek ako postoji mogućnost da ste trudni, ako niste dobili mjesečnicu ili ako dojite.
English: No reproductive toxicity studies in animals were performed, and it is not known if Lymphoseek can cause foetal harm when administered to a pregnant woman.
Croatian: Nisu provedena ispitivanja reproduktivne toksičnosti na životinjama, te nije poznato može li Lymphoseek uzrokovati oštećenje fetusa prilikom primjene u trudnica.
English: Follow appropriate radiation safety precautions during preparation and administration.
Croatian: Pridržavajte se odgovarajućih mjera zaštite od zračenja tijekom pripreme i primjene.
English: Lymphoseek has no or negligible influence on the ability to drive or use machines.
Croatian: Lymphoseek ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: This medicinal product is restricted to hospital use only.
Croatian: Ovaj je lijek ograničen samo za bolničku uporabu.
English: Since technetium (99mTc) tilmanocept contains a small amount of radioactivity it can make parts of the body areas visible to doctors during tests to help them see if the cancer has spread to places called ‘lymph nodes' that are found near tumours.
Croatian: Budući da tehnecij (99mTc) tilmanocept sadrži malu količinu radioaktivnosti, može liječnicima učiniti vidljivima dijelove tijela tijekom ispitivanja kako bi lakše utvrdili je li se rak proširio do mjesta koja se nazivaju „limfni čvorovi“ i koja se nalaze u blizini tumora.
English: Your doctor and nuclear medicine doctor will tell you when it is safe to drive after your surgery.
Croatian: Vaš liječnik i liječnik specijalist nuklearne medicine obavijestit će Vas kada možete voziti nakon kirurškog zahvata.
English: Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands
Croatian: Antonio Vivaldistraat 150 1083 HP Amsterdam Nizozemska
English: Lymphoseek must not be used after the expiry date which is stated on the carton and label after “Exp”.
Croatian: Lymphoseek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza „Rok valjanosti“ i „EXP“.
English: When the sentinel lymph node is found, the surgeon removes it.
Croatian: Ako je limfni čvor čuvar pronađen, kirurg ga uklanja.
English: 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.
Croatian: Prije primjene radiofarmaceutika majci koja doji potrebno je razmotriti mogućnost odgode primjene radionuklida sve dok majka ne prekine dojenje, te izabrati najprikladniji radiofarmaceutik, imajući na umu količinu aktivnosti koja se izluči u majčino mlijeko.
English: It is considered unlikely that Lymphoseek will affect your ability to drive or to use machines.
Croatian: Smatra se kako nije vjerojatno da će Lymphoseek utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Radiopharmaceuticals should be received, used, and administered only by authorised persons in designated clinical settings.
Croatian: Radiofarmaceutike moraju preuzimati, koristiti i primjenjivati samo ovlaštene osobe u za to određenim kliničkim uvjetima.
English: Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Lymphoseek to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
Croatian: Koristite vodootporne rukavice, djelotvornu zaštitu od zračenja i odgovarajuće mjere sigurnosti prilikom rukovanja lijekom Lymphoseek kako biste izbjegli nepotrebno ozračivanje bolesnika, zaposlenika, kliničkog osoblja i drugih osoba.
English: Please ask your nuclear medicine doctor when you can resume breast-feeding.
Croatian: Pitajte specijalista nuklearne medicine kada možete nastaviti s dojenjem.
English: Table 1.
Croatian: Tablica 1.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Instructions for the reconstitution and radiolabelling of the product are included in this pack.
Croatian: Upute za rekonstituciju i radioaktivno obilježavanje lijeka uključeni su u ovo pakiranje.
English: 1083 HP Amsterdam
Croatian: 1083 Amsterdam
English: Do not use if particulate matter and/or discoloration are seen.
Croatian: Ne koristiti ako su vidljive čestice i/ili promjena boje.
English: 1 x 0.1 mL injection
Croatian: 1 x 0,1 mL injekcija
English: Write the radioactivity amount, date and time of assay, volume, and expiration time (this is not to exceed 6 hours from preparation time) on a syringe label and affix it to the syringe(s).
Croatian: Zapišite količinu radioaktivnosti, datum i vrijeme analize, volumen i rok trajanja (koje ne smije premašiti 6 sati od trenutka pripreme) na naljepnicu štrcaljke i zalijepite na štrcaljku(e).
English: The radiolabelled solution is stable for 6 hours at a maximum of 25°C.
Croatian: Radioaktivno obilježena otopina je stabilna tijekom 6 sati ako se čuva na temperaturi od najviše 25°C.
English: Recommended time for preoperative imaging is 15 minutes post-injection but may begin as early as 10 minutes.
Croatian: Preporučeno vrijeme za preoperativno oslikavanje iznosi 15 minuta nakon injekcije, no može započeti najranije nakon 10 minuta.
English: The radiolabelled product is a clear, colourless solution with no visible particles.
Croatian: Radioaktivno obilježeni lijek je bistra, bezbojna otopina bez vidljivih čestica.
English: No clinical consequences were observed at dose levels of 3.7 times the recommended dose of Lymphoseek in humans, or at 390 times the anticipated human exposure of tilmanocept in animals.
Croatian: Nisu zabilježene kliničke posljedice pri razinama doze 3,7 puta većima od preporučene doze lijeka Lymphoseek u ljudi, niti u životinja kod izloženosti tilmanoceptu 390 puta veće od one očekivane u ljudi.
English: Lymphoseek finds the lymph nodes and can be detected using a special camera or detector.
Croatian: Lymphoseek pronalazi limfne čvorove te se može vidjeti primjenom posebne kamere ili detektora.
English: Tilmanocept is a macromolecule consisting of multiple units of diethylenetriaminepentaacetic acid (DTPA) and mannose, each synthetically attached to a 10 kDa dextran backbone.
Croatian: Tilmanocept je makromolekula koja se sastoji od više jedinica dietilentriaminpentaacetatne kiseline (DTPA) i manoze, pri čemu je svaka jedinica sintetski povezana s dekstranskom okosnicom od 10 kDa.
English: Contact your doctor if you have any questions.
Croatian: Ako imate bilo kakvih pitanja, kontaktirajte svog liječnika.
English: k. Withdraw the required volume of the radiolabelled product into the required number of syringes.
Croatian: k. Izvucite potreban volumen radioaktivno obilježenog lijeka u potreban broj štrcaljki.
English: Sodium pertechnetate (Tc 99m) injection containing oxidants should not be used to reconstitute this kit.
Croatian: Injekcija natrijevog pertehnetata (Tc 99m) koja sadrži oksidanse ne smije se koristiti za rekonstituciju ovog seta.
English: To normalize pressure, withdraw an equal volume of headspace gas.
Croatian: Kako biste normalizirali pritisak, izvucite jednaki volumen plina iznad otopine.
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Croatian: Potrebno je pažljivo razmotriti omjer koristi i rizika u ovih bolesnika budući da je moguće povećano izlaganje zračenju.
English: What Lymphoseek is and what it is used for 2.
Croatian: Što je Lymphoseek i za što se koristi 2.
English: Individual injection volumes should not exceed 0.5 mL or be less than 0.1 mL.
Croatian: Volumeni pojedinačnih injekcija ne smiju biti veći od 0,5 mL niti manji od 0,1 mL.
English: Kit for radiopharmaceutical preparation.
Croatian: Set za pripravu radiofarmaceutika.
English: These lymph nodes are where cancer cells are most likely to have spread.
Croatian: Ovi limfni čvorovi predstavljaju mjesto gdje su se stanice raka najčešće šire.
English: 4.4 Special warnings and precautions for use
Croatian: Posebna upozorenja i mjere opreza pri uporabi
English: Following reconstitution and labelling, Lymphoseek is intended to be injected in close proximity to the tumour and used in preoperative gamma detection imaging in conjunction with a stationary gamma camera (scintigraphy), single photon emissioncomputed tomography (SPECT), or SPECT/computerized tomography SPECT/CT, and/or intraoperatively in conjunction with a gamma detection probe to localise sentinel lymph nodes in the lymphatic pathway draining the tumour.
Croatian: Nakon rekonstitucije i označavanja, Lymphoseek je predviđen za ubrizgavanje u neposrednu blizinu tumora te se koristi u preoperativnom oslikavanju gama detekcijom stacionarnom gama kamerom (scintigrafija), jednofotonskom emisijskom kompjuteriziranom tomografijom (SPECT), ili SPECT/kompjuteriziranom tomografijom SPECT/CT, i/ili intraoperativno zajedno sa sondom za gama detekciju kako bi se lokalizirali limfni čvorovi čuvari u području limfne drenaže tumora.
English: j. Determine the radiochemical purity of the radiolabelled product as described below.
Croatian: j. Utvrdite radiokemijsku čistoću radioaktivno obilježenog lijeka kako je niže opisano.
English: Based on the planned number of injection syringes and the planned total injection volume per patient, determine (from Table 3 below) the reconstituted vial volume of radiolabelled Lymphoseek.
Croatian: Na temelju planiranog broja injekcijskih štrcaljki i planiranog ukupnog volumena injekcije po bolesniku, utvrdite (pomoću niže navedene tablice 3.) rekonstituirani volumen bočice radioaktivno obilježenog lijeka Lymphoseek.
English: The substance, tilmanocept, specifically binds to mannose binding receptor proteins (CD206) that reside on the surface of macrophages and dendritic cells.
Croatian: Djelatna tvar, tilmanocept, specifično se veže na receptorske proteine koji vežu manozu (CD206), a koji se nalaze na površini makrofaga i dendritičnih stanica.
English: Total injection volume should be no greater than 1.0 mL and no less than 0.1 mL.
Croatian: Ukupni volumen injekcije ne smije biti veći od 1,0 mL niti manji od 0,1 mL.
English: Do not administer the unprepared vial components of the kit directly to a patient.
Croatian: Ne primjenjujte nepripremljene bočice seta izravno bolesniku.
English: The radiation doses to organs and tissues of an average patient (70 kg) per MBq of radiolabelled Lymphoseek are shown in Table 1 and Table 2.
Croatian: Doze zračenja za organe i tkiva za prosječnog bolesnika (70 kg) po MBq radioaktivno obilježenog lijeka Lymphoseek prikazane su u tablici 1. i tablici 2.
English: The complete SmPC of Lymphoseek is provided as a tear-off section at the end of the printed leaflet 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.
Croatian: Cjeloviti sažetak opisa svojstava lijeka za Lymphoseek priložen je u pakiranju lijeka kao zaseban dokument na kraju printane verzije upute, koji je od nje odvojiv, a cilj mu je zdravstvenim radnicima pružiti dodatne znanstvene i praktične informacije o primjeni i uporabi ovoga radiofarmaceutika.
English: Other medicines and Lymphoseek
Croatian: Drugi lijekovi i Lymphoseek