natgillin/translations-raw huggingface dataset:
Intradermal, subcutaneous, intratumoural, or peritumoural use after radiolabelling with sodium pertechnetate (99mTc). 
Za intradermalnu, supkutanu, intratumoralnu ili peritumoralnu primjenu nakon radioaktivnog obilježavanja natrijevim pertehnetatom (99mTc).
Image acquisition/sentinel lymph node mapping Breast cancer, melanoma, and squamous cell carcinoma of the oral cavity applications in adults: 
Dobivanje slike/označavanje limfnog čvora čuvara Primjene u slučaju raka dojke, melanoma i karcinoma pločastih stanica oralne šupljine u odraslih:
The radiation dose to the patient would not exceed 0.69 mSv even if none of a 74 MBq dose were eliminated. 
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.
5.2 Pharmacokinetic properties 
5.2. Farmakokinetička svojstva
Effective dose (E) (females, mSv/MBq) a Calculated from data of 18 melanoma patients who received four intradermal injections of 20, 100, 
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.
Administration should occur within 30 hours of the scheduled time of the surgery and intraoperative detection. 
Lijek je potrebno primijeniti unutar 30 sati prije zakazanog kirurškog zahvata i intraoperativne detekcije.
Technetium Tc 99m tilmanocept binding is independent of tumour type or severity. 
Tc 99m neovisno je o tipu ili stupnju malignosti tumora.
Name and address of the manufacturer(s) responsible for batch release 
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
Uncommon: Incision site pain, Seroma, Wound dehiscence 
Manje često: bol na mjestu incizije, seromi, dehiscijencija rane
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. 
Medical Internal Radiation Dose) i vrijednostima MIRD S, a temelji se na biološkim podacima o unosu u organe i eliminaciji iz krvotoka.
If you get any side effects, talk to your doctor or nurse. 
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
Reproductive system and breast disorders 
Poremećaji reproduktivnog sustava i dojki
The metabolism of technetium Tc 99m tilmanocept has not been investigated experimentally. 
Tc 99m nije eksperimentalno ispitan.
If you get any side effects, talk to your nuclear medicine doctor. 
Ako primijetite bilo koju nuspojavu, obratite se specijalistu nuklearne medicine.
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. 
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).
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. 
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.
Effective dose (E) (females, mSv/MBq) a Calculated from data of 18 breast cancer patients who received four peritumoural injections of 4, 
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.
For injection after radiolabelling with sodium pertechnetate (99mTc). 
Za primjenu injekcijom nakon radioaktivnog obilježavanja natrijevim pertehnetatom (99mTc).
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. 
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.
Patients scheduled for surgery on the day of injection will receive 18.5 MBq technetium Tc 99m radiolabelled product. 
Bolesnici koji imaju zakazani kirurški zahvat na isti dan kada su primili injekciju primit će 18,5 MBq lijeka radioaktivno obilježenog tehnecijem Tc 99m.
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). 
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.
Women of childbearing potential 
Žene reproduktivne dobi
Special populations Hepatic or renal impairment 
Posebne populacije Oštećenje funkcije jetre ili bubrega
Place the vial in a radiation shield and sanitize the septum with an alcohol wipe. 
Stavite bočicu u zaštitu od zračenja i očistite pregradu alkoholnom maramicom.
Each vial contains 50 micrograms tilmanocept. 
Jedna bočica sadrži 50 mikrograma tilmanocepta.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica na bočici
Do not store above 25°C. 
Ne čuvajte na temperaturi većoj od 25°C.
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. 
Kao i u slučaju svih metabolita, posebice onih koji se u zamjetnoj mjeri eliminiraju putem jetre, očekuje se određena eliminacija tilmanocepta obilježenog radioaktivnim tehnecijem
Should you have any further questions on the use of Lymphoseek, please ask the nuclear medicine doctor who supervises the procedure. 
U slučaju bilo kakvih pitanja u vezi s primjenom lijeka Lymphoseek, obratite se svom liječniku specijalistu nuklearne medicine koji nadgleda postupak.
However, it is required that the vial be prepared as instructed and a 50 microgram aliquot be used for a single patient dose. 
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.
For the highest radiochemical purity, reconstitute with freshly eluted technetium Tc 99m generator eluate. 
Za najviši stupanj radiokemijske čistoće, rekonstituirajte svježe eluiranim eluatima generatora tehnecija
Tabulated list of adverse reactions 
Tablični popis nuspojava
Estimated dose absorbed from Lymphoseek in patients with melanomaa 
Table 2. Procijenjena apsorbirana doza za lijek Lymphoseek u bolesnika s melanomoma
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. 
Postupci primjene moraju se provesti tako da se rizik od kontaminacije lijeka i ozračivanja osoblja svede na najmanju moguću mjeru.
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. 
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.
For melanoma, administration is intradermal in single or multiple divided injections. 
U slučaju melanoma primjena je intradermalna, jednom injekcijom ili dozom podijeljenom u više injekcija.
5.1 Pharmacodynamic properties 
5.1. Farmakodinamička svojstva
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lymphoseek 50 micrograms solution for injection technetium (99mTc) tilmanocept 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Lymphoseek 50 mikrograma otopina za injekciju tehnecij (99mTc) tilmanocept
Fertility Animal fertility studies have not been conducted with Lymphoseek. 
Plodnost Nisu provedena ispitivanja utjecaja lijeka Lymphoseek na plodnosti u životinja.
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). 
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.
Sodium ascorbate (E301) Stannous chloride dihydrate (E512) Sodium hydroxide (E524) Hydrochloric acid, dilute (E507) 
Natrijev askorbat (E301) Kositrov(II) klorid dihidrat Natrijev hidroksid (E524) Razrijeđena kloridna kiselina (E507)
6.2 Incompatibilities 
Inkompatibilnosti
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. 
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.
Use only eluate from technetium Tc 99m generator which was previously eluted within 8 hours. 
Tc 99m koji su prethodno eluirani unutar 8 sati.
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]. 
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.
Estimated dose absorbed from Lymphoseek in patients with breast cancera 
Procijenjena apsorbirana doza za lijek Lymphoseek u bolesnika s rakom dojkea
Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept 
Lymphoseek 50 mikrograma set za pripravu radiofarmaceutika tilmanocept
Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials. 
Čuvanje radiofarmaceutika će biti u skladu s nacionalnim propisima o radioaktivnim materijalima.
Cardiac disorders 
Srčani poremećaji
Uncommon: Nausea 
Manje često: mučnina
The 20 microgram dose peaked at 2.5 hours with a mean %ID/g of 0.0023%/g ± 0.0005%/g. 
Doza od 20 mikrograma dosegnula je vrhunac nakon 2,5 sata s prosječnim %ID/g od 0,0023%/g ± 0,0005%/g.
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. 
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
MARKETING AUTHORISATION HOLDER 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Uncommon: Vision blurred 
Manje često: zamagljen vid
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. 
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.
Do not use if vial integrity appears compromised. 
Ne koristite ako se bočica čini oštećenom.
Trehalose dihydrate Glycine (E640) 
Glicin (E640)
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%. 
Ne koristite radioaktivno obilježeni Lymphoseek ako je radiokemijska čistoća manja od 90%.
BATCH NUMBER 
4. BROJ SERIJE
What to do after adminstration of Lymphoseek 
Što morate učiniti nakon primjene lijeka Lymphoseek?
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials. 
Čuvanje radiofarmaceutika mora biti u skladu s nacionalnim propisima o radioaktivnim materijalima.
Uncommon: Breast pain 
Manje često: bol u dojkama
Uptake of technetium Tc 99m tilmanocept into the primary sentinel node increased dose-dependently: Lymphoseek injection at 20, 100, and 200 micrograms produced LSN values of 5.01 ± 8.02 pmol, 17.5 ± 13.7 pmol, and 58.2 ± 41.2 pmol of technetium Tc 99m tilmanocept, respectively. 
Tc 99m u primarni čvor čuvar rastao je ovisno o dozi: pri primjeni lijeka Lymphoseek u dozama 20, 100 i 200 mikrograma, LSN vrijednosti iznosile su od 5,01 ± 8,02 pmol, 17,5 ± 13,7 pmol, odnosno 58,2 ± 41,2 pmol tilmanocepta obilježenog radioaktivnim tehnecijem
The %ID for liver, kidneys, and bladder as calculated from the whole body scans of melanoma patients at 1 and 12 hours after administration ranged from 1.1% to 3.1% at 1 hour, and all decreased to less than 1% by 12 hours. 
Vrijednost %ID za jetru, bubrege i mjehur izračunat na temelju snimanja cijeloga tijela u bolesnika s rakom dojke 1, 2,5 i 12 sati nakon primjene bio je niži od 2,6% u svim vremenima (za sve razine doza zajedno), a %ID za jetru, bubrege i mjehur izračunat na temelju snimanja cijeloga tijela u bolesnika s melanomom 1 i 12 sati nakon primjene bio je između 1,1% i 3,1% u prvom satu, te se u svim slučajevima smanjio na manje od 1% do 12. sata.
Chronic or acute overdose is unlikely to occur given the total injection amount. 
S obzirom na ukupnu dozu lijeka u injekciji, nije vjerojatno kronično niti akutno predoziranje.
This medicine contains less than 1 mmol sodium (23 mg) per dose. 
Lymphoseek sadrži natrij: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
How to use Lymphoseek 
Kako primjenjivati Lymphoseek
How to store Lymphoseek 
Kako čuvati Lymphoseek
• blurred vision 
• navale crvenila
For squamous cell carcinoma of the oral cavity, administration is peritumoural (multiple divided injections). 
U slučaju karcinoma pločastih stanica usne šupljine, primjena je peritumorska (dozom podijeljenom u više injekcija).
Nervous system disorders 
Poremećaji probavnog sustava
A handheld gamma counter (represented by any handheld gamma detection probe) was used intraoperatively to identify sentinel lymph nodes localising technetium Tc 99m. 
Ručni gama brojač (bilo koja ručna sonda za otkrivanje gama zračenja) korišten je intraoperativno za identifikaciju limfnih čvorova čuvara lokaliziranih tehnecijem
Method of preparation Preparation of the Lymphoseek radiolabelled solution for injection from the kit is done by the following aseptic procedure: a. Prior to radiolabelling, inspect the tilmanocept powder vial for any damage. 
Način pripreme Priprema radioaktivno obilježene otopine lijeka Lymphoseek za injekciju iz seta obavlja se sljedećim aseptičkim postupkom: a.
i. Assay the radiolabelled vial for total radioactivity using a dose calibrator. 
Analizirajte ukupnu radioaktivnost u radioaktivno obilježenoj bočici kalibratorom doze.
CLINICAL PARTICULARS 
4. KLINIČKI PODACI
What Lymphoseek looks like and contents of the pack Before it is used, the powder in the vial is mixed with another medicine called sodium pertechnetate to make a substance called technetium (99mTc) tilmanocept. 
Prije uporabe, prašak u bočici miješa se s drugim lijekom naziva natrijev pertehnetat za potrebe pripreme tvari naziva tehnecij (99mTc) tilmanocept.
Discard unused product. 
Neiskorišteni lijek bacite.
Please refer to the SmPC [SmPC should be included in the box]. 
Pročitajte sažetak opisa svojstava lijeka [sažetak opisa svojstava lijeka mora biti priložen u kutiji].
• increased heart rate 
• ubrzan puls
Biodex 150-001 Red Strips b. Apply a small drop (3 - 10 microliters) of the radiolabelled product at the center of the origin line chromatography strip. 
Primijenite malu kapljicu (3 - 10 mikrolitara) radioaktivno obilježenog lijeka u središte bazne linije kromatografske trakice.
PHARMACEUTICAL PARTICULARS 
6. FARMACEUTSKI PODACI
Lymphoseek 50 micrograms kit for radiopharmaceutical preparation 
NAZIV LIJEKA Lymphoseek 50 mikrograma set za pripravu radiofarmaceutika
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Lymphoseek 50 mikrograma set za pripravu radiofarmaceutika tilmanocept
Relative to the pathology status of lymph node collection from a complete lymph node dissection, technetium Tc 99m tilmanocept correctly localised in sentinel lymph nodes predictive of harbouring metastatic tumour in 38 of 39 patients, for a false negative rate of 2.56%. 
Tc 99m točno je lokalizirao limfne čvorove čuvare koji ukazuju na metastatski tumor u 38 od 39 bolesnika, s postotkom lažno negativnog rezultata od 2,56%.
Table 2. 
PRILOG II.
Alternatively, vital blue dye localised in 66.96% of the excised lymph nodes detected by technetium Tc 99m tilmanocept (reverse concordance). 
Alternativno, vitalna plava boja lokalizirana je u 66,96% kirurški odstranjenih limfnih čvorova otkrivenih pomoću tilmanocepta obilježenog radioaktivnim tehnecijem
In Phase 3 clinical studies, technetium Tc 99m tilmanocept was detectable in sentinel lymph nodes within 10 minutes. 
Tc 99m otkriven je u limfnim čvorovima čuvarima unutar 10 minuta.
PHARMACEUTICAL FORM 
3. FARMACEUTSKI
Store using appropriate radiation shielding. 
Čuvajte uz primjenu odgovarajuće zaštite od zračenja.
5.3 Preclinical safety data 
Neklinički podaci o sigurnosti primjene
Skin and subcutaneous tissue disorders Uncommon: Skin irritation Musculoskeletal and connective tissue disorders 
Poremećaji kože i potkožnog tkiva
Directions for radiolabelling the tilmanocept powder 50 micrograms vial with technetium Tc 99m general considerations 
Upute za radioaktivno obilježavanje bočice tilmanocept praška doze 50 mikrograma tehnecijem
What you need to know before Lymphoseek is used 3. 
Što morate znati prije nego počnete primjenjivati Lymphoseek 3. Kako primjenjivati Lymphoseek 4. Moguće nuspojave
Each Lymphoseek vial, once reconstituted and radiolabelled, would contain 50 micrograms of product with an additional overfill when prepared according to the instructions and administered as noted in Table 3. 
Nakon što se rekonstituira i radioaktivno obilježi, svaka bočica lijeka Lymphoseek treba sadržavati 50 mikrograma lijeka s dodatnim suviškom ako se pripremi u skladu s uputom i primijeni kako je navedeno u tablici 3. Suvišak iznosi 12,5 mikrograma kako bi se omogućilo ispitivanje radiokemijske čistoće i kako bi se osigurala isporuka doze od 50 mikrograma tilmanocepta.
a. Mark the chromatographic strip for origin, mid and solvent front lines with a pencil as shown below: 
Kako je prikazano niže na slici, olovkom označite na kromatografskoj trakici baznu liniju, srednju liniju i frontu otapala:
In a fixed effects meta-analysis of two Phase 3 studies, technetium Tc 99m tilmanocept localised in 99.99% of the excised lymph nodes stained blue by a vital blue dye (concordance). 
Tc 99m lokaliziran je u 99,99% kirurški odstranjenih limfnih čvorova obojanih plavom vitalnom plavom bojom (konkordancija).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER Contains an overfill. 
5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 6. DRUGO
b. For radiolabelling, use sodium pertechnetate (Tc 99m) solution from a technetium Tc 99m generator within 8 hours of its elution. 
b. Za radioaktivno obilježavanje iskoristite otopinu natrijevog pertehnetata (Tc 99m) iz tehnecij
SPECIAL STORAGE CONDITIONS Do not store above 25°C. 
Ne čuvati na temperaturi iznad 25°C.
Alternatively, vital blue dye localised in 63.50% of the excised lymph nodes detected by technetium Tc 99m tilmanocept (reverse concordance). 
Alternativno, vitalna plava boja lokalizirana je u 63,50% kirurški odstranjenih limfnih čvorova otkrivenih pomoću tilmanocepta obilježenog radioaktivnim tehnecijem
Outer carton 
Vanjska kutija
EXP: ________Time/Date 
Rok valjanosti: ________ vrijeme / datum 4. BROJ SERIJE
Trehalose, dihydrate Glycine (E640) 
Kositrov(II) klorid dihidrat (E512)
In Phase 3 clinical studies in breast cancer patients mapped with both technetium Tc 99m tilmanocept and vital blue dye, technetium Tc 99m tilmanocept localised in 99.91% of patients with a mean 2.08 localised sentinel lymph nodes per patient by fixed effects meta-analyses. 
Tc 99m lokalizirao je u 99,91% bolesnika s prosječnih 2,08 lokaliziranih limfnih čvorova čuvara po bolesniku prema meta analizama metoda fiksnih učinaka.
In the second Phase 1 study in breast cancer patients in which patients were injected with 20 micrograms Lymphoseek, the mean elimination rate constant of technetium Tc 99m tilmanocept was 0.299/h and the drug half-life at the injection site was 2.6 h. The %IDSN was 1.68% ± 1.22% in the 3 hour injection-to-surgery group and 1.81% ± 2.19% in the Lymphoseek 16 hour injection-to-surgery group. 
U skupini koja je primila injekciju 3 sata prije kirurškog zahvata %IDSN iznosio je 1,68% ± 1,22%, a 1,81% ± 2,19% u skupini koja je primila injekciju lijeka Lymphoseek 16 sati prije kirurškog zahvata.
In one Phase 3 clinical study in patients with intraoral or cutaneous squamous cell carcinoma, technetium Tc 99m tilmanocept localised sentinel lymph nodes in 97.59% of patients who underwent lymph node evaluation. 
Tc 99m lokalizirao je limfne čvorove čuvare u 97,59% bolesnika koji su podvrgnuti evaluaciji limfnih čvorova.
Assay the syringe for technetium Tc 99m activity in a dose calibrator. 
Tc 99m kalibratorom doze.
Disposal of radiopharmaceuticals should be done in accordance with national regulation on radioactive materials. 
Radiofarmaceutike treba zbrinuti sukladno nacionalnim propisima o radioaktivnim materijalima.
In Phase 3 clinical studies in melanoma patients mapped with both technetium Tc 99m tilmanocept and vital blue dye, technetium Tc 99m tilmanocept localised in 99.89% of patients with a mean 2.30 localised sentinel lymph nodes per patient by fixed effects meta-analyses. 
Tc 99m lokaliziran je u 99,89% bolesnika s prosječnih 2,30 lokaliziranih limfnih čvorova čuvara po bolesniku prema meta analizama metoda fiksnih učinaka.
PHARMACOLOGICAL PROPERTIES 
5. FARMAKOLOŠKA SVOJSTVA
Posology 
Doziranje
Lymphoseek contains sodium 
Kako Lymphoseek izgleda i sadržaj pakiranja
Do not store above 25ºC Contains an overfill. 
Ne čuvati na temperaturi iznad 25ºC
Assay the syringe(s) in a dose calibrator. 
Analizirajte štrcaljke kalibratorom doze.
Careful consideration of the activity to be administered in these patients is required since an increased radiation exposure is possible. 
Budući da je moguće povećano izlaganje zračenju potrebno je pažljivo razmotriti količinu aktivnosti koja će se primijeniti u ovih bolesnika.
MARKETING AUTHORISATION NUMBER(S) 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
System Organ Class (SOC) 
Klasifikacija organskih sustava
Vascular disorders 
Prijavljivanje nuspojava
Breast-feeding It is not known whether technetium Tc 99m tilmanocept is excreted into human milk. 
Dojenje Nije poznato izlučuje li se tilmanocept obilježen radioaktivnim tehnecijem
Total volume to be injected Total Lymphoseek vial reconstitution volume 
Ukupan volumen rekonstituirane bočice lijeka Lymphoseek