FrancophonIA/ELRC3.0 huggingface dataset:
English: • The active substance is tilmanocept.
Maltese: • Is-sustanza attiva hija tilmanocept.
English: % RCP = Counts (activity) in bottom half x 100
Maltese: % RCP = Għadd (attività) fin-nofs ta' taħt x 100
English: Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands
Maltese: Antonio Vivaldistraat 150 1083 HP Amsterdam L-Olanda
English: Table 2.
Maltese: Tabella 2.
English: Netherlands
Maltese: L-Olanda
English: 4.3 Contraindications
Maltese: .3. Kontraindikazzjonijiet
English: Summary of safety profile
Maltese: Sommarju tal-profil ta' sigurtà
English: Excipients:
Maltese: Eċċipjenti:
English: Total volume: ________mL
Maltese: Volum totali: ________mL
English: 1 vial
Maltese: 1 kunjett
English: For each injection prepare a separate syringe.
Maltese: Għal kull injezzjoni lesti siringa separata.
English: EXP: ________Time/Date
Maltese: JIS: ________Ħin/Data
English: Calibration time: ________Time/Date
Maltese: Ħin ta' kalibrar: ________ Ħin/Data
English: Adequate shielding is mandatory.
Maltese: Protezzjoni adegwata hija obbligatorja.
English: 5 vials
Maltese: 5 kunjetti
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Mhux applikabbli.
English: 6 hours.
Maltese: 6 sigħat.
English: d. Calculate the percent radiochemical purity (% RCP) as follows:
Maltese: d. Ikkalkula l-perċentwal ta' purità radjukimika (% RCP) kif ġej:
English: Individual benefit/risk justification
Maltese: Benefiċċju individwali/ġustifikazzjoni tar-riskju
English: For patient preparation, see section 4.4.
Maltese: Għat-tħejjija tal-pazjent, ara sezzjoni 4.4.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża
English: Determination of injection volumes
Maltese: Determinazzjoni tal-volumi ta' injezzjoni
English: Whatman Grade 1, 3MM, 31ET Chromatography strip
Maltese: Strixxa KromatografikaWhatman Grad 1, 3MM,
English: Table 4: Example of three-sigma rule threshold Background counta
Maltese: Tabella 4: Eżempju ta' limitu tat-three-sigma rule Għadd tal-isfonda
English: Lot:
Maltese: Lott:
English: Date of first authorisation: 19 November 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Novembru 2014
English: Uncommon: Sinus tachycardia
Maltese: Mhux komuni: Takikardija tas-sinus
English: Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza huma definiti kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000) u mhux magħrufa (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli).
English: • flushing
Maltese: • fwawar
English: Sodium ascorbate (E301) Stannous chloride dihydrate (E512) Sodium hydroxide (E524) Hydrochloric acid, dilute (E507)
Maltese: Sodium ascorbate (E301) Stannous chloride, dihydrate (E512) Sodium hydroxide (E524) Hydrochloric acid, dilwit (E507)
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100):
English: • The other ingredients are trehalose, dihydrate, glycine (E640), sodium ascorbate (E301), stannous chloride, dihydrate, sodium hydroxide (E524) and hydrochloric acid, dilute (E507).
Maltese: • Is-sustanzi l-oħra huma trehalose, dihydrate, glycine (E640), sodium ascorbate (E301), stannous chloride, dihydrate, sodium hydroxide (E524) u aċidu idrokloriku, dilwit (E507).
English: 20, and 100 microgram doses of Lymphoseek.
Maltese: dożi ta' 20, 100, u 200 mikrogramma Lymphoseek.
English: The radiolabelled solution is stable for 6 hours at a maximum of 25°C.
Maltese: Is-soluzzjoni radjutikkettata hija stabbli għal 6 sigħat f'temperatura massima ta' 25°C.
English: Effective preoperative imaging procedures include planar gamma camera scintigraphy, SPECT, and SPECT/CT.
Maltese: Il-proċeduri effettivi ta' teħid tal-immaġnijiet wara l-operazzjonijiet jinkludu xintigrafija bil-kamera gamma planari, SPECT, u SPECT/CT.
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.
Maltese: Wara r-rikostituzzjoni u t-tikkettar, Lymphoseek huwa mfassal biex jiġi injettat qrib it-tumur u jintuża fitteħid ta' immaġnijiet ta' detezzjoni gamma qabel l-intervent kirurġiku flimkien ma' kamera gamma wieqfa (xintigrafija), tomografija kompjuterizzata b'emissjoni ta' foton wieħed (single photon emissioncomputed tomography - SPECT), jew SPECT/tomografija kompjuterizzata SPECT/CT, u/jew bejn operazzjoni u oħra flimkien ma' sonda gamma ta' detezzjoni li tfittex u ssib nodi limfatiċi sentinelli fil-passaġġ limfatiku li jkun qed joskula t-tumur.
English: Mid Line
Maltese: Linja Medja
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: Gastrointestinal disorders
Maltese: Disturbi gastro-intestinali
English: DOSIMETRY
Maltese: Technetium
English: Adverse Drug Reaction (ADR)
Maltese: Reazzjoni Avversa għall-Mediċina (ADR, Adverse Drug Reaction)
English: The metabolism of technetium Tc 99m tilmanocept has not been investigated experimentally.
Maltese: Il-metaboliżmu ta' technetium Tc 99m tilmanocept ma ġiex investigat permezz ta' esperimenti.
English: LIST OF EXCIPIENTS
Maltese: Lista ta' eċċipjenti
English: Marketing Authorisation Holder Norgine B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Norgine B.V.
English: Uncommon: Aphasia, Dizziness, Headache, Paraesthesia
Maltese: Mhux komuni: Afażja, Sturdament, Uġigħ ta' ras, Paresteżija
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).
Maltese: Ħalli s-solvent jimxi sal-linja ta' quddiem tas-solvent (5 cm mill-qiegħ tal-istrixxi Whatman u 3.5 cm mill-istrixxa Biodex).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) f'kull doża.
English: f. Aseptically add sodium pertechnetate (Tc 99m) solution (from step d above) to the tilmanocept powder vial.
Maltese: f. Żid b'mod asettiku soluzzjoni ta' sodium pertechnetate (Tc 99m) (mill-punt d hawn fuq) fil-kunjett tattrab tilmanocept.
English: Estimated radiation absorbed dose for melanoma, mGy/MBq Target organ
Maltese: Stima tad-doża ta' radjazzjoni assorbita għall-melanoma, mGy/MBq Organu fil-mira
English: Pack-size of 1 and 5 vials.
Maltese: Daqs tal-pakkett ta' 1 kunjett u ta' 5 kunjetti.
English: Each vial contains 50 micrograms tilmanocept.
Maltese: Kull kunjett fih 50 mikrogramma tilmanocept.
English: Pharmacotherapeutic group: diagnostic radiopharmaceutical, tumour detection, ATC Code: V09IA09.
Maltese: Kategorija farmakoterapewtika: radjufarmaċewtiku dijanjostiku, skoperta tat-tumuri, Kodiċi ATC:
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:
Maltese: Determinazzjoni tal-purità radjukimika ta' Lymphoseek radjutikkettat Iddetermina l-purità radjukimika ta' Lymphoseek radjutikkettat permezz ta' Instant Thin Layer Chromatography (ITLC) kemm billi tuża Whatman Grade 1, 3MM, 31ET Chr kif ukoll Strixxi Ħomor Biodex 150-001 (karta taċ-ċelluloża għall-kromatografija) u bil-metodu li ġej:
English: 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.
Maltese: It-teħid ta' technetium Tc 99m tilmanocept fin-nodu ewlieni sentinella żdied skont id-doża: l-injezzjoni ta' Lymphoseek f'20, 100, u 200 mikrogramma pproduċiet valuri LSN ta' 5.01 ± 8.02 pmol, 17.5 ± 13.7 pmol, u 58.2 ± 41.2 pmol ta' technetium Tc 99m tilmanocept, rispettivament.
English: Uncommon: Incision site pain, Seroma, Wound dehiscence
Maltese: Mhux komuni: Uġigħ fil-post tal-ferita, Seroma, ftuħ ta' feriti
English: 4.6 Fertility, pregnancy and lactation
Maltese: Fertilità, tqala u treddigħ
English: Italia
Maltese: L-Italja
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%.
Maltese: L-eżattezza globali ta' technetium Tc 99m tilmanocept għall-identifikazzjoni ta' pazjenti vera pożittivi u vera negattivi rigward il-patoloġija finnodi limfatiċi lokalizzati kienet ta' 98.80%.
English: • All lymphatic mapping agents use elements of the lymphatic system for distribution.
Maltese: • Is-sustanzi kollha tal-immappjar limfatiku jużaw elementi tas-sistema limfatika għad-distribuzzjoni.
English: Tilmanocept is a macromolecule consisting of multiple units of diethylenetriaminepentaacetic acid (DTPA) and mannose, each synthetically attached to a 10 kDa dextran backbone.
Maltese: Tilmanocept huwa makromolekula li tikkonsisti f'diversi unitajiet ta' aċidu diethylenetriaminepentaacetic acid (DTPA) u mannose, kull wieħed imwaħħal b'mod sintetiku ma' sinsla dextran 10 kDa.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Clinical efficacy
Maltese: Effikaċja klinika
English: 6.2 Incompatibilities
Maltese: Inkompatibbiltajiet
English: • In clinical studies, patients received Lymphoseek up to 30 hours before surgery.
Maltese: • Fi studji kliniċi, il-pazjenti ngħataw Lymphoseek sa 30 siegħa qabel l-intervent kirurġiku.
English: Uncommon: Hypercalcaemia
Maltese: Mhux komuni: Iperkalċemija
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)
Maltese: ◦ Irritazzjoni fil-post tal-injezzjoni (0.7%; 4 minn 553 pazjent)
English: Elderly patients aged 65 or older (32%) were evaluated in clinical studies; no safety issues were identified.
Maltese: Il-pazjenti anzjani ta' 65 sena jew aktar (32%) ġew ivvalutati fi studji kliniċi; ma ġiet identifikata l-ebda kwistjoni ta' sigurtà.
English: Tabulated list of adverse reactions
Maltese: Lista f'tabella ta' reazzjonijiet avversi
English: Uncommon: Flushing
Maltese: Mhux komuni: Fwawar
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.
Maltese: Il-%IDSN li ttieħed fin-nodu limfatiku ewlieni kien ta' 0.50% għad-doża ta' 20 mikrogramma, 0.35% għad-doża ta' 100 mikrogramma, 0.58% għad-doża ta' 200 mikrogramma ta' Lymphoseek.
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.
Maltese: Il-%ID tal-plażma għal kull gramma għal żewġ livelli ta' dożi laħaq il-massimu f'4 sigħat; il-valuri medji għad-dożi ta' 4 u 100 mikrogramma kienu 0.0090%/g ± 0.0048%/g u 0.0039%/g ± 0.0046%/g, rispettivament.
English: Table 3: Lymphoseek injections by injection volume Desired number of injections
Maltese: Tabella 3: Injezzjonijiet ta' Lymphoseek skont il-volum ta' injezzjoni
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lymphoseek 50 micrograms solution for injection technetium (99mTc) tilmanocept
Maltese: U MNEJN GĦANDU JINGĦATA Lymphoseek 50 mikrogramma soluzzjoni għall-injezzjoni technetium (99mTc) tilmanocept
English: The 20 microgram dose peaked at 2.5 hours with a mean %ID/g of 0.0023%/g ± 0.0005%/g.
Maltese: Id-doża ta' 20 mikrogramma laħqet il-massimu f'sagħtejn u nofs b'%ID/g medju ta' 0.0023%/g ± 0.0005%/g.
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva u fissider
English: Kit for radiopharmaceutical preparation.
Maltese: Informazzjoni għall-pazjent
English: Children and adolescents
Maltese: Tfal u adolexxenti
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.
Maltese: It-teħid ta' technetium Tc 99m tilmanocept finnodu ewlieni sentinella żdied skont id-doża (p=0.009): l-injezzjoni ta' Lymphoseek f'4, 20, u 100 mikrogramma pproduċiet livelli ta' nodi sentinelli ewlenin (LSN) ta' 0.09 ± 0.20 pmol, 6.53 ± 2.52 pmol, u 10.
English: Technetium Tc 99m tilmanocept is eliminated primarily through the kidneys.
Maltese: Tc 99m tilmanocept huwa eliminat primarjament mill-kliewi.
English: • Periodic safety update reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: 5 x 0.2 mL injections, or 4 x 0.25 mL injections, or 2 x 0.5 mL injections
Maltese: 2 injezzjonijiet ta' 0.25 mL kull waħda, jew injezzjoni waħda ta' 0.5 mL
English: A handheld gamma counter (represented by any handheld gamma detection probe) was used intraoperatively to identify sentinel lymph nodes localising technetium Tc 99m.
Maltese: Kontatur gamma li jinżamm fl-idejn (irrappreżentat minn kwalunkwe sonda ta' detezzjoni gamma li tinżamm flidejn) intuża bejn operazzjoni u oħra sabiex jidentifika nodi limfatiċi sentinelli li jillokalizzaw technetium Tc 99m.
English: For injection after radiolabelling with sodium pertechnetate (99mTc).
Maltese: Għall-injezzjoni wara r-radjutikkettar b'sodium pertechnetate (99mTc).
English: Estimated dose absorbed from Lymphoseek in patients with melanomaa
Maltese: Stima tad-doża assorbita minn Lymphoseek fil-pazjenti b'melanomaa
English: • blurred vision
Maltese: • vista mċajpra
English: Three-sigma threshold value a Average of three 2-second counts or one 10-second count
Maltese: Il-valur tal-limitu tat-three-sigma a Medja ta' tliet għedud ta' 2 sekondi jew għadd wieħed ta' 10 sekondi
English: Assay the syringe(s) in a dose calibrator.
Maltese: Ipprova s-siringa/i f'kalibratur tad-dożi.
English: Total volume to be injected Total Lymphoseek vial reconstitution volume
Maltese: Numru mixtieq ta' injezzjonijiet Volum totali li għandu jiġi injettat
English: Lymphoseek 50 micrograms kit for radiopharmaceutical preparation tilmanocept
Maltese: Lymphoseek 50 mikrogramma sett għal tħejjija radjufarmaċewtika tilmanocept
English: Assay the syringe for technetium Tc 99m activity in a dose calibrator.
Maltese: Ipprova s-siringa għall-attività ta' technetium Tc 99m f'kalibratur tad-dożi.
English: Tilmanocept may be metabolised in the liver to its component molecules, namely dextran (which is renally excreted and/or further metabolised to glucose), mannose (an endogenous sugar) and diethylenetriaminepentaacetic acid (which is renally excreted).
Maltese: Tilmanocept jista' jkun immetabolizzat filfwied għall-molekuli tal-komponenti tiegħu, jiġifieri dextran (li jitneħħa mill-kliewi u/jew ikompli jiġi mmetabolizzat għal glukożju), mannose (zokkor endoġenu) u aċidu diethylenetriaminepentaacetic (li jitneħħa mill-kliewi).
English: The 99mTc shows the surgeon where the sentinel lymph nodes are located.
Maltese: It-99mTc juri lill-kirurgu fejn jinsabu n-nodi limfatiċi sentinelli.
English: Potential for hypersensitivity or anaphylactic reactions The possibility of hypersensitivity including severe life-threatening fatal anaphylactic / anaphylactoid reactions must always be considered.
Maltese: Il-potenzjal ta' sensittività eċċessiva jew reazzjonijiet anafilattiċi Il-possibbiltà ta' sensittività eċċessiva inklużi reazzjonijiet anafilattiċi/anafilattojdi fatali għandha dejjem tkun ikkunsidrata.
English: The pharmacokinetics of technetium Tc 99m tilmanocept in patients with renal or hepatic impairment have not been characterised (see section 5.2).
Maltese: Il-farmakokinetika ta' technetium Tc 99m tilmanocept f'pazjenti b'insuffiċjenza talkliewi jew tal-fwied ma ġietx ikkaratterizzata (ara sezzjoni 5.2).
English: Intradermal, subcutaneous, intratumoural, or peritumoural use after radiolabelling with sodium pertechnetate (99mTc).
Maltese: Użu minn ġol-ġilda, taħt il-ġilda, fit-tumur, jew madwar it-tumur wara r-radjutikkettar b'sodium pertechnetate (99mTc).
English: Origin Line 1 cm from Bottom
Maltese: Inizjali 1 cm mill-Qiegħ
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.
Maltese: Peress li d-doża effettiva għal adult (70 kg) hija 0.69 mSv meta tingħata l-attività massima rrakkomandata ta' 74
English: Kit for radiopharmaceutical preparation 1 vial
Maltese: Fi studji kliniċi tal-Fażi 1, madwar
English: 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.
Maltese: Applika qatra żgħira (3 - 10 mikrolitri) tal-prodott radjutikkettat fiċ-ċentru tal-linja inizjali tal-istrixxa kromatografika.
English: Vascular disorders
Maltese: Disturbi vaskulari
English: 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.
Maltese: Il-%IDSN kien 1.68% ± 1.22% fil-grupp li ħa l-injezzjoni 3 sigħat qabel l-intervent kirurġiku u 1.81% ± 2.19% fil-grupp Lymphoseek li ħa l-injezzjoni 16-il siegħa qabel l-intervent kirurġiku.
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].
Maltese: Fi studji kliniċi li jużaw Lymphoseek, l-investigaturi tal-istudju użaw regola ta' limitu għal-lokalizzazzjoni pożittiva ta' technetium Tc 99m li kienet stmata bl-użu tal-għadd ta' radjuattività tal-isfond miżjuda bi tliet devjazzjonijiet standard mil-livell ta' għadd ta'sfond medju (jiġifieri, it-three-sigma rule, li tirrappreżenta >99.7% probabbiltà ta' differenza mill-isfond) [ara tTabella 4].
English: Trehalose dihydrate Glycine (E640)
Maltese: Glycine (E640)
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.
Maltese: It-tħarbit tal-arkitettura u l-funzjoni tas-sistema limfatika sottostanti permezz ta' kirurġija estensiva preċedenti, radjazzjoni, jew mard metastatiku tista' tirriżulta f'lokalizzazzjoni mnaqqsa ta' Lymphoseek fin-nodi limfatiċi.
English: Posology
Maltese: LISTA
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.
Maltese: Il-perċentwal ta' doża injettata li laħqet in-nodu sentinella ewlieni (%IDSN) kien 0.05% ± 0.10%, 0.52% ± 0.38%, 0.
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).
Maltese: MBq (2.0 mCi) xejn ma jiġi eliminat (ara sezzjoni 4.2).
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.
Maltese: Id-doża ta' 100 mikrogramma laħqet il-massimu f'siegħa u f'sagħtejn b' %ID/g medju ta' 0.0018%/g ± 0.001%/g f'kull punt ta' ħin.
English: How to use Lymphoseek
Maltese: Lymphoseek
English: EXPIRY DATE
Maltese: DATA TA' SKADENZA
English: • headache
Maltese: • uġigħ
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.
Maltese: Id-dożi ta' radjazzjoni għall-organi u t-tessuti ta' pazjent medju (70 kg) għal kull MBq ta'Lymphoseek radjutikkettat huma mogħtija fit-Tabella 1 u t-Tabella 2.
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.
Maltese: Lymphoseek radjutikkettat huwa indikat għat-teħid ta' xbihat u għall-kxif intraoperattiv ta' nodi limfatiċi sentinelli li jkunu qegħdin jostru tumur primarju f'pazjenti adulti b'kanċer tas-sider, melanoma, jew karċinoma lokalizzat taċ-ċelluli skwamużi fil-kavità orali.
English: The total injection amount should not exceed 50 micrograms tilmanocept, with a total maximum radioactivity of 74 MBq per dose.
Maltese: L-ammont totali injettat ma għandux jaqbeż il-50 mikrogramma tilmanocept, b'radjuattività massima totali ta' 74
English: Reporting of suspected adverse reactions
Maltese: Rappurtar ta' reazzjonijiet avversi ssuspettati
English: Pregnancy
Maltese: Pożoloġija
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
Maltese: Adulti b'melanoma il-moħħ is-sider (sit tal-injezzjoni) il-ħajt tal-marrara il-ħajt t'isfel tal-intestin il-kbir l-intestin iż-żgħir l-istonku il-ħajt ta' fuq tal-intestin il-kbir il-kilwa il-fwied il-pulmun il-muskoli l-ovarji il-mudullun aħmar l-għadam il-milsa it-testikoli it-timu it-tirojde il-bużżieqa tal-awrina il-ġisem kollu (id-demm)b
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Adults 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
Maltese: Adulti il-moħħ is-sider (sit tal-injezzjoni) il-ħajt tal-marrara il-ħajt t'isfel tal-intestin il-kbir l-intestin iż-żgħir l-istonku il-ħajt ta' fuq tal-intestin il-kbir il-kilwa il-fwied il-pulmun il-muskoli l-ovarji il-mudullun aħmar l-għadam il-milsa it-testikoli it-timu it-tirojde il-bużżieqa tal-awrina il-ġisem kollu (id-demm)b