FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 x 0.1 mL injections, or 2 x 0.25 mL injections, or 1 x 0.5 mL injection
Slovenian: 5 x 0,1 ml injekcije ali 2 x 0,25 ml injekciji ali 1 x 0,5 ml injekcija
English: 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.
Slovenian: Vrednost %ID za jetra, ledvice in sečni mehur, kot je bila izračunana na podlagi slikanj celotnega telesa pri bolnikih z melanomom 1 in 12 ur po injiciranju, je bila od 1,1 % do 3,1 % po 1 uri in se je do 12 ur pri vseh zmanjšala na manj kot 1 %.
English: The estimated radiation dose to the patient would not exceed 0.69 mSv even if none of a 74 MBq dose (2.0 mCi) were eliminated (see section 4.2).
Slovenian: Ocenjeni odmerek sevanja pri bolniku ne bo presegel 0,69 mSv, tudi če v telesu ostane celoten odmerek 74 MBq (2,0 mCi) (glejte poglavje 4.2).
English: 4.4 Special warnings and precautions for use
Slovenian: Posebna opozorila in previdnostni ukrepi
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%.
Slovenian: Splošna točnost s tehnecijem Tc99m označenega tilmanocepta pri zaznavanju pravilno pozitivnih in pravilno negativnih bolnikov glede na patologijo v lokaliziranih bezgavkah je bila 98,80-odstotna.
English: Contact your doctor if you have any questions.
Slovenian: Če imate kakršna koli vprašanja, se posvetujte z zdravnikom.
English: Adding very large volumes of tracing agents or other injectants temporally or anatomically proximal to Lymphoseek could affect the in vivo disposition of Lymphoseek.
Slovenian: Dodajanje zelo velikih prostornin sledilcev ali drugih snovi za injiciranje kmalu po injiciranju zdravila Lymphoseek ali v bližino njegovega injiciranja bi lahko vplivalo na porazdelitev zdravila Lymphoseek in vivo.
English: Place the vial in a radiation shield and sanitize the septum with an alcohol wipe.
Slovenian: Vialo postavite v ščit pred sevanjem in pregrado očistite z alkoholnim robčkom.
English: Distortion of the underlying lymphatic system architecture and function by prior extensive surgery, radiation, or metastatic disease may result in diminished Lymphoseek localisation in lymph nodes.
Slovenian: Nepravilnosti na arhitekturi limfnih obtočil pod preiskovanim tkivom, ki so posledica predhodnega obsežnega kirurškega posega, sevanja ali metastatske bolezni, lahko poslabšajo lokalizacijo bezgavk z zdravilom Lymphoseek.
English: 6.2 Incompatibilities
Slovenian: Inkompatibilnosti
English: Intradermal, subcutaneous, intratumoural, or peritumoural use after radiolabelling with sodium pertechnetate (99mTc).
Slovenian: Intradermalna, subkutana, intratumorna ali peritumorna uporaba po radiooznačevanju z natrijevim pertehnetatom (99mTc).
English: EXP: ________Time/Date
Slovenian: Uporabno do: ________čas/datum
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
English: If you are breast-feeding, breast milk should be discarded for 24 hours after administration of Lymphoseek.
Slovenian: Če dojite, je treba zavreči mleko, nastalo v 24 urah po prejemu zdravila Lymphoseek.
English: 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.
Slovenian: Priprava radiooznačene raztopine zdravila Lymphoseek na injiciranje vključuje naslednji aseptični postopek: a. Pred označevanjem preglejte vialo s praškom tilmanocepta in se prepričajte, da ni poškodovana.
English: The imaging and detection of sentinel lymph nodes with Lymphoseek is dependent upon its specific molecular targeting and binding to reticuloendothelial cells within lymph nodes.
Slovenian: Slikanje in zaznavanje varovalnih bezgavk z zdravilom Lymphoseek sta odvisna od specifičnega načina izbire molekularnih tarč in vezave na retikuloendotelijske celice v bezgavkah.
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:
Slovenian: Določanje radiokemijske čistote radiooznačenega zdravila Lyphoseek Radiokemijsko čistoto radiooznačenega zdravila Lymphoseek določite s hitro tankoplastno kromatografijo (Instant Thin Layer Chromatography - ITLC), pri kateri uporabite pripomočke Whatman Grade 1, 3MM, 31ET Chr ali Biodex 150-001 Red Strips (celulozni papir za kromatografijo).
English: Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.
Slovenian: Radiološko označeno zdravilo Lymphoseek je indicirano za slikanje in medoperacijsko zaznavanje varovalnih bezgavk, v katere odtekajo maligne celice primarnega tumorja pri odraslih bolnikih z rakom dojke, melanomom ali lokaliziranim skvamoznim karcinomom ustne votline.
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.
Slovenian: Pred uporabo se prašek v viali, ki vsebuje tilmanocept, zmeša z radioaktivnim zdravilom, imenovanim natrijev pertehnetat (ki vsebuje 99mTc), s čimer se pridobi snov, imenovana tehnecijev (99mTc) tilmanocept.
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Slovenian: Če niste gotovi, je pomembno, da se posvetujte z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
English: The total injection amount should not exceed 50 micrograms tilmanocept, with a total maximum radioactivity of 74 MBq per dose.
Slovenian: Skupna injicirana količina ne sme preseči 50 mikrogramov tilmanocepta s skupno največjo radioaktivnostjo 74 MBq na odmerek.
English: The nuclear medicine doctor uses a special camera to find Lymphoseek.
Slovenian: Zdravnik nuklearne medicine zdravilo Lymphoseek poišče s posebno kamero.
English: Table 3: Lymphoseek injections by injection volume Desired number of injections
Slovenian: Preglednica 3: Injiciranje zdravila Lymphoseek glede na prostornino injekcije
English: The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder.
Slovenian: Viala vsebuje sterilni, apirogeni, bel do umazano bel liofilizirani prašek.
English: For squamous cell carcinoma of the oral cavity, administration is peritumoural (multiple divided injections).
Slovenian: Pri skvamoznem karcinomu ustne votline je uporaba peritumorna (večkratno ločeno injiciranje).
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Navedba smiselno ni potrebna.
English: The metabolism of technetium Tc 99m tilmanocept has not been investigated experimentally.
Slovenian: Presnove s tehnecijem Tc99m označenega tilmanocepta niso preučevali eksperimentalno.
English: Intradermal, subcutaneous, intratumoural, or peritumoural use.
Slovenian: Intradermalna, subkutana, intratumorna ali peritumorna uporaba.
English: The %ID for liver, kidneys, and bladder as calculated from the whole body scans of breast cancer patients at 1, 2.5, and 12 hours after administration was below 2.6% at all times (all dose levels combined).
Slovenian: Vrednost %ID za jetra, ledvice in sečni mehur, kot se je izračunala na podlagi slikanj celega telesa pri bolnicah z rakom dojke 1, 2,5 in 12 ur po injiciranju, je bila ves čas manjša od 2,6 % (za vse odmerke).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: For the highest radiochemical purity, reconstitute with freshly eluted technetium Tc 99m generator eluate.
Slovenian: Za najboljšo radiokemijsko čistoto rekonstituirajte s sveže eluiranim eluatom iz generatorja tehnecija Tc99m.
English: Women of childbearing potential
Slovenian: Ženske v rodni dobi
English: Follow appropriate radiation safety precautions during preparation and administration.
Slovenian: Med pripravo in dajanjem upoštevajte ustrezne varnostne ukrepe glede sevanja.
English: The overall rate of agreement between lymph node localisation (determined by radioactivity detection) on preoperative lymphoscintigraphy and intraoperative lymph node survey was 97.8% for all patients.
Slovenian: Splošni delež skladnosti pri določanju mesta bezgavk (kar se je določilo radiološko) s predoperacijsko limfoscintigrafijo in medoperacijski preiskavi bezgavk je bil pri vseh bolnikih 97,8-odstoten.
English: What you need to know before Lymphoseek is used 3.
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Lymphoseek 3.
English: In external gamma imaging analysis, bound technetium Tc 99m tilmanocept has been shown to be retained in the same draining lymph nodes for up 30 hours.
Slovenian: V analizi zunanjega slikanja gama so pokazali, da vezani, s tehnecijem Tc99m označeni tilmanocept v istih drenažnih bezgavkah ostane do 30 ur.
English: 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.
Slovenian: Izgled zdravila Lymphoseek in vsebina pakiranja Pred uporabo se prašek v viali zmeša z drugim zdravilom, imenovanim natrijev pertehnetat, s čimer se pridobi snov, imenovana tehnecijev (99mTc) tilmanocept.
English: Administration should occur within 15 hours of the scheduled time of the surgery and intraoperative detection.
Slovenian: Injiciranje je treba opraviti v 15 urah pred načrtovanim kirurškim posegom in medoperacijskim zaznavanjem.
English: For each patient, the radiation exposure must be justifiable by the likely benefit.
Slovenian: Presoja razmerja med tveganji in koristmi pri posameznem bolniku Pri vsakem bolniku je treba izpostavljenost sevanju upravičiti z verjetno koristjo.
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).
Slovenian: d. S sterilno injekcijsko brizgo aseptično izvlecite približno 23,1 MBq ali 92,5 MBq raztopine natrijevega pertehnetata (Tc99m) v prostornino približno 0,125 ml (za 0,125 ml rekonstituirane prostornine) ali približno 0,5 ml (za 0,625 ml ali 1,25 ml rekonstituirane prostornine).
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).
Slovenian: Porazdelitev V eni študiji 1. faze pri bolnicah z rakom dojke so pokazali, da je imelo zdravilo Lymphoseek pri vseh treh preizkušenih odmerkih (4, 20 in 100 mikrogramih) hiter očistek na mestu injiciranja (hitrost izločanja je bila konstantna v razponu med 0,222/h in 0,278/h).
English: Uncommon: Injection site irritation, Injection site pain, Feeling hot
Slovenian: Občasni: draženje na mestu injiciranja, bolečina na mestu injiciranja, občutek vročice
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: Zdravilo Lymphoseek vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek.
English: 6.4 Special precautions for storage
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE
English: Each 50 microgram vial contains an additional overfill to ensure that 50 micrograms of tilmanocept can be delivered.
Slovenian: Ena viala 50 mikrogramov vsebuje dodatno čezmerno količino, kar zagotavlja, da se bo dalo 50 mikrogramov tilmanocepta.
English: What you need to know before Lymphoseek is used
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Lymphoseek
English: • The other ingredients are trehalose, dihydrate, glycine (E640), sodium ascorbate (E301), stannous chloride, dihydrate, sodium hydroxide (E524) and hydrochloric acid, dilute (E507).
Slovenian: • Druge sestavine zdravila so trehaloza, dihidrat, glicin (E 640), natrijev askorbat (E 301), kositrov klorid, dihidrat, natrijev hidroksid (E 524) in klorovodikova kislina, razredčena (E 507).
English: Uncommon: Incision site pain, Seroma, Wound dehiscence
Slovenian: Občasni: bolečina na mestu incizije, serom, dehiscenca rane
English: Intraoperative lymphatic mapping may begin as early as 15 minutes post injection.
Slovenian: Medoperacijsko mapiranje bezgavk se lahko začne že 15 minut po injiciranju.
English: How to store Lymphoseek 6.
Slovenian: Shranjevanje zdravila Lymphoseek 6.
English: Breast-feeding It is not known whether technetium Tc 99m tilmanocept is excreted into human milk.
Slovenian: Dojenje Ni znano, ali se s tehnecijem Tc99m označen tilmanocept izloča v materino mleko.
English: The mean diameter of tilmanocept is 7 nm and this small molecular size permits enhanced transit into lymphatic channels resulting in rapid and consistent injection site clearance.
Slovenian: Ta majhna velikost molekule omogoča pospešen prehod v limfne kanale, kar povzroči hiter in enakomeren očistek na mestu injiciranja.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: Patients scheduled for surgery on the day after injection will receive 74 MBq technetium Tc 99m radiolabelled product.
Slovenian: Bolniki, pri katerih načrtujejo kirurški poseg dan po injiciranju, bodo prejeli zdravilo, radiološko označeno s tehnecijem Tc99m, z aktivnostjo 74 MBq.
English: The total injection amount should not exceed 50 micrograms tilmanocept, with a total maximum radioactivity of 74 MBq (2.0 mCi) per dose.
Slovenian: Skupna injicirana količina ne sme preseči 50 mikrogramov tilmanocepta s skupno največjo radioaktivnostjo 74 MBq (2,0 mCi) na odmerek.
English: Each vial contains 50 micrograms tilmanocept.
Slovenian: Ena viala vsebuje 50 mikrogramov tilmanocepta.
English: Technetium Tc 99m tilmanocept is eliminated primarily through the kidneys.
Slovenian: Izločanje S tehnecijem Tc99m označen tilmanocept se primarno izloča skozi ledvice.
English: Directions for radiolabelling the tilmanocept powder 50 micrograms vial with technetium Tc 99m general considerations
Slovenian: Navodila za radiooznačevanje viale s praškom tilmanocepta 50 mikrogramov s tehnecijem Tc99m
English: Administration should occur within 30 hours of the scheduled time of the surgery and intraoperative detection.
Slovenian: Injiciranje je treba opraviti v 30 urah pred načrtovanim kirurškim posegom in medoperacijskim zaznavanjem.
English: Solvent Front Line
Slovenian: Sprednja črta za topilo
English: How to use Lymphoseek
Slovenian: Kako uporabljati zdravilo Lymphoseek
English: Uncommon: Pain in extremity, Musculoskeletal pain, Neck pain, Pain in jaw
Slovenian: Občasni: bolečina v okončini, mišično-skeletna bolečina, bolečina v vratu, bolečina v čeljusti
English: Image acquisition/sentinel lymph node mapping Breast cancer, melanoma, and squamous cell carcinoma of the oral cavity applications in adults:
Slovenian: Zajem slike/mapiranje varovalnih bezgavk Uporaba pri raku dojke, melanomu in skvamoznem karcinomu ustne votline pri odraslih:
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.
Slovenian: Vrednost %ID na gram v plazmi za dva odmerka je bila največja po 4 urah; povprečni vrednosti za odmerka 4 in 100 mikrogramov sta bili 0,0090 %/g ± 0,0048 %/g oziroma 0,0039 %/g ± 0,0046 %/g.
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.
Slovenian: Priporočeni odmerek je 50 mikrogramov tilmanocepta, radiološko označenega s tehnecijem Tc99m pri 18,5 MBq za kirurški poseg v istem dnevu ali 74 MBq za kirurški poseg naslednji dan. Odmerek 50 mikrogramov se ne sme prilagajati glede na razlike v telesni masi.
English: EXP: The radiolabelled solution can be used for 6 hours when stored below 25°C.
Slovenian: Radiooznačena raztopina se lahko shranjuje 6 ur pri temperaturi do 25°C.
English: It is considered unlikely that Lymphoseek will affect your ability to drive or to use machines.
Slovenian: Ni verjetno, da bo imelo zdravilo Lymphoseek vpliv na spodobnost upravljanja vozil in strojev.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lymphoseek 50 micrograms solution for injection technetium (99mTc) tilmanocept
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Lymphoseek 50 mikrogramov raztopina za injiciranje tehnecijev (99mTc) tilmanocept
English: f. Aseptically add sodium pertechnetate (Tc 99m) solution (from step d above) to the tilmanocept powder vial.
Slovenian: f. Viali s praškom tilmanocepta aseptično dodajte raztopino natrijevega pertehnetata (Tc99m) (iz zgornjega koraka d).
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).
Slovenian: h. Radiooznačenemu zdravilu v viali s praškom tilmanocepta po potrebi aseptično dodajte sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %), da prostornino v rekonstituirani viali povečate do 0,125 ml, 0,625 ml ali 1,25 ml, preden napolnite bolnikov odmerek v injekcijsko(e) brizgo(e).
English: This medicinal product must be radiolabelled before administration to the patient.
Slovenian: Preden se zdravilo da bolniku, ga je treba radiološko označiti.
English: Chronic or acute overdose is unlikely to occur given the total injection amount.
Slovenian: Glede na skupni injicirani odmerek ni verjetno, da bo prišlo do kroničnega ali akutnega prevelikega odmerjanja.
English: For injection after radiolabelling with sodium pertechnetate (99mTc).
Slovenian: POSTOPEK UPORABE Za injiciranje po radiooznačevanju z natrijevim pertehnetatom (99mTc).
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).
Slovenian: Zdravilo Lymphoseek je radiofarmak, usmerjen na receptorje in zasnovan za hitro prehajanje skozi limfne žile; je biološko usmerjen na primarne ključne napovedne drenažne bezgavke (varovalne bezgavke) in se nakopiči ter zadrži v njih.
English: Technetium Tc 99m tilmanocept binding is independent of tumour type or severity.
Slovenian: Vezava s tehnecijem Tc99m označenega tilmanocepta ni odvisna od vrste ali resnosti tumorja.
English: 5.3 Preclinical safety data
Slovenian: Predklinični podatki o varnosti
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.
Slovenian: Na nalepko za ščit, priloženo kompletu, zabeležite koncentracijo aktivnosti tehnecija Tc99m, skupno prostornino, čas ter datum preizkusa, rok uporabnosti in številko serije.
English: Disposal of radiopharmaceuticals should be done in accordance with national regulation on radioactive materials.
Slovenian: Odstranjevanje radiofarmakov mora potekati v skladu z nacionalnimi predpisi o radioaktivnih materialih.
English: Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept
Slovenian: Lymphoseek 50 mikrogramov komplet za pripravo radiofarmaka tilmanocept
English: • If you get any side effects, talk to your nuclear medicine doctor.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom nuklearne medicine.
English: The sentinel lymph nodes are then checked to see if cancer cells have spread to them.
Slovenian: Potem bezgavke preučijo in preverijo, ali so se vanje razširile rakave celice.
English: Determination of injection volumes
Slovenian: Določanje prostornine injiciranja
English: This medicinal product is for diagnostic use only.
Slovenian: Zdravilo je samo za diagnostične namene.
English: • Keep this leaflet.
Slovenian: • Navodilo shranite.
English: 4.3 Contraindications
Slovenian: Kontraindikacije
English: Alternatively, vital blue dye localised in 66.96% of the excised lymph nodes detected by technetium Tc 99m tilmanocept (reverse concordance).
Slovenian: Nasprotno se je z vitalnim modrim barvilom lokaliziralo 66,96 % odstranjenih bezgavk, zaznanih s tilmanoceptom, označenim s tehnecijem Tc99m (reverzno ujemanje).
English: Uncommon: Vision blurred
Slovenian: Občasni: zamegljen vid
English: 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).
Slovenian: V metaanalizi fiksnih učinkov dveh študij 3. faze je s tehnecijem Tc99m označeni tilmanocept lokaliziralo 99,99 % odstranjenih bezgavk, ki so se z vitalnim modrim barvilom obarvale modro (ujemanje).
English: Uncommon: Nausea
Slovenian: Občasni: zardevanje
English: The radiation dose to the patient would not exceed 0.69 mSv even if none of a 74 MBq dose were eliminated.
Slovenian: Odmerek sevanja pri bolniku ne bo presegel 0,69 mSv, tudi če v telesu ostane celoten odmerek 74 MBq.
English: Table 2.
Slovenian: Preglednica 2.
English: Uncommon: Micturition urgency, Pollakiuria
Slovenian: Občasni: močna nuja po uriniranju, polakisurija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Nalepka na viali
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable.
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI Navedba smiselno ni potrebna.
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.
Slovenian: Odmerek mora v času injiciranja vsebovati najmanj predvideno raven radioaktivnosti Tc99m, ki je pri kirurškem posegu na isti dan 18,5 MBq, pri kirurškem posegu, ki se opravi naslednji dan, pa 74 MBq.
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.
Slovenian: Vrednost %ID na gram v plazmi za dva odmerka je bila največja po 15 minutah; povprečni vrednosti za odmerka 20 in 200 mikrogramov sta bili 0,0104 %/g ± 0,0135 %/g oziroma 0,0065 %/g ± 0,0082 %/g.
English: Store using appropriate radiation shielding.
Slovenian: Pri shranjevanju uporabljajte ustrezen ščit pred sevanjem.
English: If you get any side effects, talk to your nuclear medicine doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom nuklearne medicine.
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.
Slovenian: Večanje privzema s tehnecijem Tc99m označenega tilmanocepta v primarni varovalni bezgavki je bilo odvisno od odmerka (p = 0,009): injiciranje zdravila Lymphoseek v odmerkih 4, 20 in 100 mikrogramov je povzročilo ravni s tehnecijem Tc99m označenega tilmanocepta v primarni varovalni bezgavki (LSN) 0,09 ± 0,20 pmol, 6,53 ± 2,52 pmol oziroma 10,58 ± 8,43 pmol.