FrancophonIA/ELRC3.0 huggingface dataset:
English: Determination of radiochemical purity of radiolabelled Lymphoseek Determine radiochemical purity of the radiolabelled Lymphoseek by Instant Thin Layer Chromatography (ITLC) using either Whatman Grade 1, 3MM, 31ET Chr or Biodex 150-001 Red Strips (cellulose chromatography paper) using the following method:
Croatian: Utvrđivanje radiokemijske čistoće radioaktivno obilježenog lijeka Lymphoseek Sljedećom metodom utvrdite radiokemijsku čistoću radioaktivno obilježenog lijeka Lymphoseek pomoću instantne tankoslojne kromatografije (ITLC) primjenom papira Whatman br. 1, 3MM, 31ET Chr ili crvenih trakica Biodex 150-001 (celulozni papir za kromatografiju):
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Zbog toga se moraju poduzeti mjere zaštite od zračenja u skladu s nacionalnim propisima.
English: The surgeon uses the pictures taken to see where the sentinel lymph nodes are located.
Croatian: Kirurg koristi te snimke kako bi utvrdio gdje se nalaze limfni čvorovi čuvari.
English: Unopened vial
Croatian: Neotvorena bočica
English: In in vitro studies, technetium Tc 99m tilmanocept exhibited specific and tight binding to human CD206 receptors with a primary binding site affinity of Kd = 2.76 x x 10-11 M. In Phase 1 clinical studies,
Croatian: Tc 99m pokazao je specifično i snažno vezanje za humane CD206 receptore s afinitetom za primarno mjesto vezivanja od Kd = 2,76 x 10-11
English: f. Aseptically add sodium pertechnetate (Tc 99m) solution (from step d above) to the tilmanocept powder vial.
Croatian: f. Aseptičkom tehnikom dodajte otopinu natrijevog pertehnetata (Tc 99m) (iz prethodnog koraka d) u bočicu praška tilmanocepta.
English: approximately 0.5 to 1.8% of the dose is accumulated in draining lymph nodes through specific binding after 30 minutes.
Croatian: U kliničkim ispitivanjima faze I, otprilike 0,5 do 1,8% doze akumulirano je u drenažnim limfnim čvorovima specifičnim vezivanjem nakon 30 minuta.
English: Intraoperative lymphatic mapping may begin as early as 15 minutes post injection.
Croatian: Intraoperativno limfatičko označavanje može započeti najranije 15 minuta nakon primjene injekcije.
English: Eye disorders
Croatian: Poremećaji oka
English: The overall accuracy of technetium Tc 99m tilmanocept for identification of true positive and true negative patients relative to pathology in the localised lymph nodes was 98.80%.
Croatian: Tc 99m u identifikaciji stvarno pozitivnih i stvarno negativnih bolesnika u odnosu na patološki nalaz u lokaliziranim limfnim čvorovima iznosila je 98,80%.
English: d. Using a sterile syringe, aseptically draw approximately 23.1 MBq or 92.5 MBq of sodium pertechnetate (Tc 99m) solution in either about 0.125 mL volume (for 0.125 mL reconstituted vial volume) or about 0.5 mL volume (for 0.625 mL or 1.25 mL reconstituted vial volume).
Croatian: d. Pomoću sterilne štrcaljke aseptičkim postupkom uvucite otprilike 23,1 MBq ili 92,5 MBq otopine natrijevog pertehnetata (Tc 99m) u otprilike 0,125 mL volumena (za bočicu rekonstituiranog volumena od 0,125 mL) ili otprilike 0,5 mL volumena (za bočicu rekonstituiranog volumena od 0,625 mL ili 1,25 mL).
English: The mannose acts as a substrate for the receptor, and the DTPA serves as a chelating agent for labelling with technetium Tc 99m.
Croatian: Manoza djeluje kao supstrat za receptor, a DTPA služi kao kelacijsko sredstvo za označavanje tehnecijem
English: Adults with melanoma brain breast (injection site) gall bladder wall lower large intestine wall small intestine stomach upper large intestine wall kidney liver lungs muscle ovaries red marrow bone spleen testes thymus thyroid urinary bladder total body (blood)b
Croatian: Odrasla osoba s melanomom mozak dojka (mjesto injekcije) stijenka žučnog mjehura stijenka donjeg debelog crijeva tanko crijevo želudac stijenka gornjeg debelog crijeva bubreg jetra pluća mišići jajnici crvena koštana srž kost slezena testisi timus štitna žlijezda mokraćni mjehur cijelo tijelo (krv)b
English: Patients scheduled for surgery on the day after injection will receive 74 MBq technetium Tc 99m radiolabelled product.
Croatian: Bolesnici za koje je zakazan kirurški zahvat dan nakon primjene injekcije primit će 74 MBq lijeka radioaktivno obilježenog tehnecijem Tc 99m.
English: Technetium Tc 99m labelling reactions depend on maintaining the stannous ion in the reduced state.
Croatian: Tc 99m ovise o održavanju iona kositra u reduciranom stanju.
English: Uncommon: Pain in extremity, Musculoskeletal pain, Neck pain, Pain in jaw
Croatian: Manje često: bol u ekstremitetima, mišićno-koštana bol, bol u vratu, bol u čeljusti
English: Radiation safety - Product handling
Croatian: Sigurnost pri zračenju - rukovanje lijekom
English: The total injection amount should not exceed 50 micrograms tilmanocept, with a total maximum radioactivity of 74 MBq (2.0 mCi) per dose.
Croatian: Ukupna količina u injekciji ne smije biti veća od 50 mikrograma tilmanocepta, s ukupnom maksimalnom radioaktivnošću od 74 MBq (2,0 mCi) po dozi.
English: The lymph nodes nearest the tumour are called ‘sentinel' lymph nodes.
Croatian: Limfni čvorovi koji su najbliže tumoru nazivaju se limfni čvorovi „čuvari“.
English: The total injection amount should not exceed 50 micrograms tilmanocept, with a total maximum radioactivity of 74 MBq per dose.
Croatian: Ukupna doza lijeka u injekciji ne smije biti veća od 50 mikrograma tilmanocepta, s ukupnom maksimalnom radioaktivnošću od 74 MBq po dozi.
English: The recommended dose is 50 micrograms tilmanocept radiolabelled with technetium Tc 99m at 18.5 MBq for same day surgery or 74 MBq for next day surgery.
Croatian: Preporučena doza iznosi 50 mikrograma tilmanocepta radioaktivno obilježenog tehnecijem Tc 99m s aktivnošću od 18,5 MBq ako se kirurški zahvat provodi isti dan ili s aktivnošću od 74 MBq ako se kirurški zahvat provodi sljedeći dan.
English: Write the technetium Tc 99m activity concentration, total volume, assay time and date, expiration time, and lot number on the shield label supplied with the kit.
Croatian: Tc 99m, ukupni volumen, vrijeme i datum analize, rok trajanja i broj serije na naljepnicu za zaštitu koja se isporučuje sa setom.
English: As the effective dose to an adult (70 kg) is 0.69 mSv when the maximal recommended activity of 74 MBq is administered adverse reactions are expected to occur with a low probability.
Croatian: Budući da kod primjene maksimalne preporučene aktivnosti od 74 MBq efektivna doza zračenja u odraslih osoba (70 kg) iznosi 0,69 mSv, vjerojatnost pojave nuspojava je mala.
English: Each 50 microgram vial contains an additional overfill to ensure that 50 micrograms of tilmanocept can be delivered.
Croatian: Jedna bočica od 50 mikrograma sadrži dodatni suvišak kako bi se osigurala doza od 50 mikrograma tilmanocepta.
English: Technetium Tc 99m tilmanocept is eliminated primarily through the kidneys.
Croatian: Tc 99m eliminira se primarno putem bubrega.
English: In one Phase 1 study in breast cancer patients, Lymphoseek at all three doses tested (4, 20, and 100 micrograms) exhibited fast injection site clearance (elimination rate constants in the range of 0.222/h to 0.278/h).
Croatian: U jednom ispitivanju faze I provedenom u bolesnika s rakom dojke, Lymphoseek testiran u sve tri doze (4, 20, i 100 mikrograma) brzo je eliminiran s mjesta injekcije (konstante stope eliminacije bile su u rasponu od 0,222/h do 0,278/h).
English: Administration should occur within 15 hours of the scheduled time of the surgery and intraoperative detection.
Croatian: Lijek je potrebno primijeniti unutar 15 sati prije zakazanog kirurškog zahvata i intraoperativne detekcije.
English: 1 vial
Croatian: 1 bočica
English: Lymphoseek is a receptor-targeted radiopharmaceutical that is designed to rapidly transit lymphatic vessels; it biotargets, accumulates, and is retained in primary, key predictive, draining lymph nodes (sentinel lymph nodes).
Croatian: Lymphoseek je radiofarmaceutik usmjeren na receptor osmišljen kako bi brzo prolazio limfni sustav; on se ciljano veže, nakuplja i zadržava u primarnim, predikcijski ključnim drenažnim limfnim čvorovima (limfni čvorovi čuvari).
English: Before it is used, the powder in the vial which contains tilmanocept is mixed with a radioactive medicine called sodium pertechnetate (containing 99mTc) to make a substance called technetium (99mTc) tilmanocept.
Croatian: Prije primjene, prašak u bočici koji sadrži tilmanocept miješa se s radioaktivnim lijekom naziva natrijev pertehnetat (koji sadrži 99mTc) za pripremu tvari naziva tehnecij (99mTc) tilmanocept.
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Croatian: Za čuvanje ovog lijeka u za to namijenjenom prostoru odgovoran je specijalist.
English: The vial components of the kit are sterile, non-pyrogenic, and are intended solely for use in the preparation of Lymphoseek.
Croatian: Bočice, kao dio seta, su sterilne, nepirogene i predviđene isključivo za potrebe pripreme lijeka Lymphoseek.
English: For breast cancer, administration is intradermal, subareolar (single or multiple divided injections) or peritumoural (multiple divided injections).
Croatian: U slučaju raka dojke, primjena je intradermalna, subareolarna (jednom injekcijom ili dozom podijeljenom u više injekcija) ili peritumorska (dozom podijeljenom u više injekcija).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Intradermal, subcutaneous, intratumoural, or peritumoural use after radiolabelling with sodium pertechnetate (99mTc).
Croatian: Za intradermalnu, supkutanu, intratumoralnu ili peritumoralnu primjenu nakon radioaktivnog obilježavanja natrijevim pertehnetatom (99mTc).
English: Image acquisition/sentinel lymph node mapping Breast cancer, melanoma, and squamous cell carcinoma of the oral cavity applications in adults:
Croatian: Dobivanje slike/označavanje limfnog čvora čuvara Primjene u slučaju raka dojke, melanoma i karcinoma pločastih stanica oralne šupljine u odraslih:
English: The radiation dose to the patient would not exceed 0.69 mSv even if none of a 74 MBq dose were eliminated.
Croatian: Doza zračenja u bolesnika neće iznositi više od 0,69 mSv čak i ako se niti jedan dio primijenjene doze od 74 MBq ne eliminira.
English: 5.2 Pharmacokinetic properties
Croatian: 5.2. Farmakokinetička svojstva
English: Effective dose (E) (females, mSv/MBq) a Calculated from data of 18 melanoma patients who received four intradermal injections of 20, 100,
Croatian: Efektivna doza (E) (žene, mSv/MBq) a Izračunato na temelju podataka 18 bolesnika oboljelih od melanoma koji su primili četiri intradermalne injekcije u dozama od 20, 100 i 200 mikrograma lijeka Lymphoseek.
English: Administration should occur within 30 hours of the scheduled time of the surgery and intraoperative detection.
Croatian: Lijek je potrebno primijeniti unutar 30 sati prije zakazanog kirurškog zahvata i intraoperativne detekcije.
English: Technetium Tc 99m tilmanocept binding is independent of tumour type or severity.
Croatian: Tc 99m neovisno je o tipu ili stupnju malignosti tumora.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Uncommon: Incision site pain, Seroma, Wound dehiscence
Croatian: Manje često: bol na mjestu incizije, seromi, dehiscijencija rane
English: The radiation dose estimation for a number of organs is based on MIRD reference man and MIRD S values, and has been calculated from biological data of organ uptake and blood clearance.
Croatian: Medical Internal Radiation Dose) i vrijednostima MIRD S, a temelji se na biološkim podacima o unosu u organe i eliminaciji iz krvotoka.
English: If you get any side effects, talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki
English: The metabolism of technetium Tc 99m tilmanocept has not been investigated experimentally.
Croatian: Tc 99m nije eksperimentalno ispitan.
English: If you get any side effects, talk to your nuclear medicine doctor.
Croatian: Ako primijetite bilo koju nuspojavu, obratite se specijalistu nuklearne medicine.
English: The dose must contain no less than the intended level of Tc 99m radioactivity for same day surgery (18.5 MBq) or next day surgery (74 MBq) at the time of administration.
Croatian: Ovisno o predviđenom zahvatu, doza u trenutku primjene ne smije sadržavati razinu Tc 99m radioaktivnosti manju od one predviđene za kirurški zahvat koji se obavlja na isti dan (18,5 MBq) odnosno one predviđene za kirurški zahvat koji se obavlja sljedećeg dana (74 MBq).
English: The percent-of-injected dose reaching the primary sentinel node (%IDSN) was 0.05% ± 0.10%, 0.52% ± 0.38%, 0.21% ± 0.17% in the 4, 20, and 100 microgram Lymphoseek dose groups, respectively.
Croatian: Postotak ubrizgane doze koji je dosegnuo primarni čvor čuvar (%IDSN) iznosio je 0,05% ± 0,10%, 0,52% ± 0,38%, odnosno 0,21% ± 0,17% u skupini koja je primala 4, 20, odnosno 100 mikrograma lijeka Lymphoseek.
English: Effective dose (E) (females, mSv/MBq) a Calculated from data of 18 breast cancer patients who received four peritumoural injections of 4,
Croatian: Efektivna doza (E) (žene, mSv/MBq) a Izračunato na temelju podataka 18 bolesnika oboljelih od raka dojke koji su primili četiri peritumorske injekcije u dozama od 4, 20 i 100 mikrograma lijeka Lymphoseek.
English: For injection after radiolabelling with sodium pertechnetate (99mTc).
Croatian: Za primjenu injekcijom nakon radioaktivnog obilježavanja natrijevim pertehnetatom (99mTc).
English: The plasma %ID per gram for two dose levels peaked at 4 hours; the mean values for the 4 and 100 microgram doses were 0.0090%/g ± 0.0048%/g and 0.0039%/g ± 0.0046%/g, respectively.
Croatian: U plazmi je vrijednost %ID po gramu za dvije razine doze dosegnula vrhunac nakon 4 sata, pri čemu su srednje vrijednosti za doze od 4 i 100 mikrograma iznosile 0,0090%/g ± 0,0048%/g, odnosno 0,0039%/g ± 0,0046%/g.
English: Patients scheduled for surgery on the day of injection will receive 18.5 MBq technetium Tc 99m radiolabelled product.
Croatian: Bolesnici koji imaju zakazani kirurški zahvat na isti dan kada su primili injekciju primit će 18,5 MBq lijeka radioaktivno obilježenog tehnecijem Tc 99m.
English: h. Aseptically add sterile sodium chloride 9 mg/mL (0.9%) solution for injection, if needed, to the radiolabelled product in the tilmanocept powder vial to bring the volume to the reconstituted vial volume of 0.125 mL, 0.625 mL, or 1.25 mL prior to filling the patient dose in syringe(s).
Croatian: h. Po potrebi aseptičkom tehnikom dodajte sterilnu 0,9%-tnu otopinu natrijevog klorida (9 mg/mL) za injekciju u radioaktivno obilježeni lijek u bočici praška tilmanocepta kako biste dobili rekonstituirani volumen bočice od 0,125 mL, 0,625 mL ili 1,25 mL prije punjenja bolesniku pripadajuće doze u jednu ili više štrcaljki.
English: Women of childbearing potential
Croatian: Žene reproduktivne dobi
English: Special populations Hepatic or renal impairment
Croatian: Posebne populacije Oštećenje funkcije jetre ili bubrega
English: Place the vial in a radiation shield and sanitize the septum with an alcohol wipe.
Croatian: Stavite bočicu u zaštitu od zračenja i očistite pregradu alkoholnom maramicom.
English: Each vial contains 50 micrograms tilmanocept.
Croatian: Jedna bočica sadrži 50 mikrograma tilmanocepta.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica na bočici
English: Do not store above 25°C.
Croatian: Ne čuvajte na temperaturi većoj od 25°C.
English: As with all general metabolites, especially those in which the liver plays a measurable roll of elimination, some biliary elimination of technetium Tc 99m tilmanocept is also likely to occur.
Croatian: Kao i u slučaju svih metabolita, posebice onih koji se u zamjetnoj mjeri eliminiraju putem jetre, očekuje se određena eliminacija tilmanocepta obilježenog radioaktivnim tehnecijem
English: Should you have any further questions on the use of Lymphoseek, please ask the nuclear medicine doctor who supervises the procedure.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom lijeka Lymphoseek, obratite se svom liječniku specijalistu nuklearne medicine koji nadgleda postupak.
English: However, it is required that the vial be prepared as instructed and a 50 microgram aliquot be used for a single patient dose.
Croatian: No, bočica se mora pripremiti u skladu s uputama te se količina koja odgovara dozi od 50 mikrograma mora primijeniti kao pojedinačna doza u bolesnika.
English: For the highest radiochemical purity, reconstitute with freshly eluted technetium Tc 99m generator eluate.
Croatian: Za najviši stupanj radiokemijske čistoće, rekonstituirajte svježe eluiranim eluatima generatora tehnecija
English: Tabulated list of adverse reactions
Croatian: Tablični popis nuspojava
English: Estimated dose absorbed from Lymphoseek in patients with melanomaa
Croatian: Table 2. Procijenjena apsorbirana doza za lijek Lymphoseek u bolesnika s melanomoma
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Croatian: Postupci primjene moraju se provesti tako da se rizik od kontaminacije lijeka i ozračivanja osoblja svede na najmanju moguću mjeru.
English: The 100 microgram dose peaked at 1 and 2 hours with a mean %ID/g of 0.0018%/g ± 0.001%/g at each timepoint.
Croatian: Doza od 100 mikrograma dosegnula je vrhunac nakon 1 i 2 sata s prosječnim %ID/g od 0,0018%/g ± 0,001%/g u svakoj vremenskoj točki.
English: For melanoma, administration is intradermal in single or multiple divided injections.
Croatian: U slučaju melanoma primjena je intradermalna, jednom injekcijom ili dozom podijeljenom u više injekcija.
English: 5.1 Pharmacodynamic properties
Croatian: 5.1. Farmakodinamička svojstva
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lymphoseek 50 micrograms solution for injection technetium (99mTc) tilmanocept
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Lymphoseek 50 mikrograma otopina za injekciju tehnecij (99mTc) tilmanocept
English: Fertility Animal fertility studies have not been conducted with Lymphoseek.
Croatian: Plodnost Nisu provedena ispitivanja utjecaja lijeka Lymphoseek na plodnosti u životinja.
English: In the Phase 1 study in melanoma patients, Lymphoseek at all three doses tested (20, 100, and 200 micrograms) cleared the injection site with elimination rate constants in the range of 0.227/h to 0.396/h, resulting in drug half-life at the injection site of 1.75 to 3.05 h).
Croatian: U jednom ispitivanju faze I provedenom u bolesnika s melanomom, Lymphoseek testiran u sve tri doze (20, 100 i 200 mikrograma) eliminiran je s mjesta injekcije konstantom stope eliminacije u rasponu od 0,227/h do 0,396/h, rezultirajući poluvijekom na mjestu primjene od 1,75 do 3,05.
English: Sodium ascorbate (E301) Stannous chloride dihydrate (E512) Sodium hydroxide (E524) Hydrochloric acid, dilute (E507)
Croatian: Natrijev askorbat (E301) Kositrov(II) klorid dihidrat Natrijev hidroksid (E524) Razrijeđena kloridna kiselina (E507)
English: 6.2 Incompatibilities
Croatian: Inkompatibilnosti
English: The plasma %ID per gram for two dose levels peaked at 15 minutes; the mean values for the 20 and 200 microgram doses were 0.0104%/g ± 0.0135%/g and 0.0065%/g ± 0.0082%/g, respectively.
Croatian: Vrijednost %ID u plazmi po gramu za razine dvije doze dosegnuo je vrhunac nakon 15 minuta, pri čemu su srednje vrijednosti za doze od 20 i 200 mikrograma bile 0,0104%/g ± 0,0135%/g, odnosno 0,0065%/g ± 0,0082%/g.
English: Use only eluate from technetium Tc 99m generator which was previously eluted within 8 hours.
Croatian: Tc 99m koji su prethodno eluirani unutar 8 sati.
English: In clinical studies using Lymphoseek, study investigators employed a threshold rule for positive localisation of technetium Tc 99m that was estimated using the background radioactivity counts plus three standard deviations from the mean background count level (i.e., the three-sigma rule, representing >99.7% probable difference from background) [see Table 4].
Croatian: Tc 99m koji je procijenjen zbrajanjem pozadinske radioaktivnosti plus tri standardne devijacije prosječnog pozadinskog broja (tj. tri sigma pravilo, predstavljajući >99,7% izglednu razliku u odnosu na pozadinu) [vidjeti tablicu 4.]. Pozadinski brojevi se tipično utvrđuju na temelju tkiva koje se nalazi najmanje 20 cm distalno u odnosu na mjesto injekcije.
English: Estimated dose absorbed from Lymphoseek in patients with breast cancera
Croatian: Procijenjena apsorbirana doza za lijek Lymphoseek u bolesnika s rakom dojkea
English: Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept
Croatian: Lymphoseek 50 mikrograma set za pripravu radiofarmaceutika tilmanocept
English: Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Croatian: Čuvanje radiofarmaceutika će biti u skladu s nacionalnim propisima o radioaktivnim materijalima.
English: Cardiac disorders
Croatian: Srčani poremećaji
English: Uncommon: Nausea
Croatian: Manje često: mučnina
English: The 20 microgram dose peaked at 2.5 hours with a mean %ID/g of 0.0023%/g ± 0.0005%/g.
Croatian: Doza od 20 mikrograma dosegnula je vrhunac nakon 2,5 sata s prosječnim %ID/g od 0,0023%/g ± 0,0005%/g.
English: Uptake of technetium Tc 99m tilmanocept into the primary sentinel node increased dose-dependently (p=0.009): Lymphoseek injection at 4, 20, and 100 micrograms produced primary sentinel node levels (LSN) of 0.09 ± 0.20 pmol, 6.53 ± 2.52 pmol, and 10.58 ± 8.43 pmol of technetium Tc 99m tilmanocept, respectively.
Croatian: Tc 99m u primarni čvor čuvar rastao je ovisno o dozi (p=0,009): pri primjeni injekcije lijeka Lymphoseek u dozi od 4, 20 odnosno 100 mikrograma, primarne razine u čvoru čuvaru (LSN) iznosile su 0,09 ± 0,20 pmol, 6,53 ± 2,52 pmol odnosno 10,58 ± 8,43 pmol tilmanocepta obilježenog tehnecijem
English: MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Uncommon: Vision blurred
Croatian: Manje često: zamagljen vid
English: The %IDSN taken up into the primary lymph node was 0.50% for the 20 microgram dose, 0.35% for the 100 microgram dose, 0.58% for the 200 microgram dose of Lymphoseek.
Croatian: Za dozu od 20 mikrograma %IDSN nakupljen u primarnom limfnom čvoru čuvaru iznosio je 0,50%, 0,35% za 100 mikrograma, 0,58% za 200 mikrograma lijeka Lymphoseek.
English: Do not use if vial integrity appears compromised.
Croatian: Ne koristite ako se bočica čini oštećenom.
English: Trehalose dihydrate Glycine (E640)
Croatian: Glicin (E640)
English: Counts(activity) in bottom half + Counts(activity) in top half e. Do not use the radiolabelled Lymphoseek if the radiochemical purity is less than 90%.
Croatian: Ne koristite radioaktivno obilježeni Lymphoseek ako je radiokemijska čistoća manja od 90%.
English: BATCH NUMBER
Croatian: 4. BROJ SERIJE
English: What to do after adminstration of Lymphoseek
Croatian: Što morate učiniti nakon primjene lijeka Lymphoseek?
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Croatian: Čuvanje radiofarmaceutika mora biti u skladu s nacionalnim propisima o radioaktivnim materijalima.
English: Uncommon: Breast pain
Croatian: Manje često: bol u dojkama