FrancophonIA/ELRC3.0 huggingface dataset:
English: Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours to technetium (99mTc) which, in view of its long half-life of 2.13 x 105 years can be regarded as quasi stable.
Maltese: Technetium (99mTc) huwa prodott permezz ta' ġeneratur (99Mo/99mTc) u jiddegrada bl-emissjoni ta' radjazzjoni gamma b'enerġija medja ta' 140 keV u nofs ħajja ta' 6.02 sigħat għal technetium (99mTc) li, fiddawl tan-nofs ħajja twila tiegħu ta' 2.13 x 105 snin jista' jitqies bħala kważi stabbli.
English: Alternatively, vital blue dye localised in 66.96% of the excised lymph nodes detected by technetium Tc 99m tilmanocept (reverse concordance).
Maltese: Għall-kuntrarju, iż-żebgħa blu vitali lokalizzat f'66.96% tan-nodi limfatiċi maqtugħa misjuba permezz ta' technetium Tc 99m tilmanocept (konkordanza bil-maqlub).
English: • After injection of Lymphoseek, external gamma detection imaging may be conducted.
Maltese: • Wara l-injezzjoni ta' Lymphoseek, jistgħu jittieħdu l-immaġnijiet gamma għad-detezzjoni esterna.
English: The place depends on the type of tumour.
Maltese: MBq) meta din tingħata.
English: 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.
Maltese: Fi studji kliniċi tal-Fażi 3 f'pazjenti b'melanoma mmappjati kemm b'technetium Tc 99m tilmanocept u żżebgħa blu vitali, technetium Tc 99m tilmanocept illokalizza f'99.89% tal-pazjenti b'medja ta' 2.30 nodi limfatiċi sentinelli lokalizzati għal kull pazjenti permezz ta' meta-analiżijiet b'effetti fissi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total activity: ________MBq
Maltese: Attività totali: ________MBq
English: These rates were significantly greater (p<0.0001) against a random effects meta-analysis of localisation rates from published literature for colloidal lymphatic mapping agents as used in European clinical practice.
Maltese: 0001) meta mqabbla ma' meta-analiżi b'effetti każwali ta' rati ta' lokalizzazzjoni mil-letteratura ppubblikata għal sustanzi tal-immappjar limfatiku kollojdali kif jintużaw filprattika klinika tal-Ewropa.
English: CAUTION RADIOACTIVE MATERIAL
Maltese: MATERJAL RADJUATTIV
English: Preoperative lymphoscintigraphy was performed in 100% of melanoma patients, 100% of head and neck squamous cell carcinoma patients, and 82% of breast cancer patients.
Maltese: Saret limfoxintigrafija ta' wara lintervent kirurġiku f'100% tal-pazjenti bil-melanoma, 100% tal-pazjenti b'karċinoma taċ-ċelloli skwamużi tar-ras u l-għonq, u 82% tal-pazjenti b'kanċer tas-sider.
English: The medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting sentinel lymph node mapping procedures.
Maltese: Il-prodott mediċinali għandu jingħata biss minn professjonisti dwar il-kura tas-saħħa mħarrġa b'esperjenza teknika fit-twettiq u l-interpretazzjoni ta' proċeduri ta' mmappjar ta' nodi limfatiċi sentinelli.
English: 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.
Maltese: Tc 99m tilmanocept u b'żebgħa blu vitali, technetium Tc 99m tilmanocept illokalizza f'99.91% tal-pazjenti b'medja ta' 2.08 nodi limfatiċi sentinelli lokalizzati għal kull pazjent b'meta-analiżijiet ta' effetti fissi.
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.
Maltese: Ikteb ilkonċentrazzjoni tal-attività ta' technetium Tc 99m, il-volum totali, il-ħin u d-data tal-prova, il-ħin ta' meta jiskadi, u n-numru tal-lott fuq it-tikketta tal-borża ta' protezzjoni pprovduta fis-sett.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi ssuspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
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).
Maltese: MBq ta' soluzzjoni sodium pertechnetate (Tc 99m) kemm f'volum ta' madwar 0.125 mL (għal volum ta' kunjett rikostitwit ta' 0.125 mL) jew volum ta' madwar 0.5 mL (għal volum ta' kunjett rikostitwit ta' 0.625 mL jew 1.25 mL).
English: Uncommon: Vision blurred
Maltese: Mhux komuni: Vista mċajpra
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).
Maltese: F'meta-analiżi b'effetti fissi ta' żewġ studji tal-Fażi 3, technetium Tc 99m tilmanocept illokalizza f'99.99% tan-nodi limfatiċi maqtugħa u miżbugħin blu permezz ta' żebgħa blu vitali (konkordanza).
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).
Maltese: Jekk meħtieġ, żid b'mod asettiku soluzzjoni sterili ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni mal-prodott radjutikkettat fil-kunjett ta' trab tilmanocept biex iġġib il-volum għall-volum tal-kunjett irrikostitwit ta' 0.125 mL, 0.625 mL, jew 1.25 mL qabel ma timla d-doża tal-pazjent fis-siringa/i.
English: Renal and urinary disorders
Maltese: Trehalose dihydrate
English: Alternatively, vital blue dye localised in 63.50% of the excised lymph nodes detected by technetium Tc 99m tilmanocept (reverse concordance).
Maltese: Għall-kuntrarju, iż-żebgħa blu vitali lokalizzat f'63.50% tan-nodi limfatiċi maqtugħa misjuba permezz ta' technetium Tc 99m tilmanocept (konkordanza bil-maqlub).
English: Skin and subcutaneous tissue disorders Uncommon: Skin irritation Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: Estimated radiation absorbed dose for breast cancer, mGy/MBq Target organ
Maltese: Stima tad-doża ta' radjazzjoni assorbita għall-kanċer tas-sider, mGy/MBq
English: For squamous cell carcinoma of the oral cavity, administration is peritumoural (multiple divided injections).
Maltese: Fil-każ ta' karċinoma taċ-ċelloli skwamużi tal-kavità orali, dan għandu jingħata madwar it-tumur (diversi injezzjonijiet diviżi).
English: Other sources of information
Maltese: Sorsi oħra ta' informazzjoni
English: b. For radiolabelling, use sodium pertechnetate (Tc 99m) solution from a technetium Tc 99m generator within 8 hours of its elution.
Maltese: Għar-radjutikkettar uża soluzzjoni ta' sodium pertechnetate (Tc 99m) minn ġeneratur ta' technetium Tc 99m fi żmien 8 sigħat mill-elużjoni tiegħu.
English: • If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tal-mediċina nukleari tiegħek li jkun qed jissorvelja lproċedura.
English: How to store Lymphoseek
Maltese: Tużax Lymphoseek
English: PHARMACEUTICAL PARTICULARS
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Lymphoseek contains sodium
Maltese: Kif jidher Lymphoseek u l-kontenut tal-pakkett
English: i. Assay the radiolabelled vial for total radioactivity using a dose calibrator.
Maltese: Ipprova l-kunjett radjutikkettat għar-radjuattività totali permezz ta' kalibratur tad-dożi.
English: Uncommon: Micturition urgency, Pollakiuria
Maltese: Mhux komuni: Irritazzjoni fil-ġilda
English: The surgeon will also use a machine that finds the 99mTc part of the medicine.
Maltese: Il-kirurgu juża wkoll apparat li jsib il-parti 99mTc tal-mediċina.
English: OTHER
Maltese: Tqala
English: Image acquisition/sentinel lymph node mapping Breast cancer, melanoma, and squamous cell carcinoma of the oral cavity applications in adults:
Maltese: Il-kisba tal-immaġni/l-immappjar ta' nodi limfatiċi sentinelli Applikazzjonijiet għall-kanċer tas-sider, melanoma, u karċinoma taċ-ċelloli skwamużi tal-kavità orali fladulti:
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.
Maltese: Ir-rata globali ta' qbil bejn is-sejbien tan-nodi limfatiċi (iddeterminat bid-deher tar-radjuattività) fil-limfoxintigrafija ta' wara l-intervent kirurġiku u listħarriġ tan-nodi limfatiċi bejn intervent u ieħor kienet ta' 97.8% għall-pazjenti kollha.
English: Dilution of the product in volumes greater than 1.0 mL could affect the in vivo disposition of Lymphoseek.
Maltese: Iddilwizzjoni tal-prodott f'volumi akbar minn 1.0 mL tista' taffettwa d-dispożizzjoni in vivo ta' Lymphoseek.
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).
Maltese: Fi studju wieħed ta' Fażi 1 fil-pazjenti bil-kanċer tas-sider, fit-tliet dożi kollha ttestjati (4, 20, u 100 mikrogramma) Lymphoseek wera eliminazzjoni rapida fis-sit tal-injezzjoni (kostanti fir-rata ta' eliminazzjoni f'medda ta' 0.222/siegħa sa 0.278/siegħa).
English: 5.2 Pharmacokinetic properties
Maltese: Tagħrif farmakokinetiku
English: • feeling sick (nausea) or dizzy
Maltese: • dardir (nawsja) jew l-isturdament
English: Uncommon: Injection site irritation, Injection site pain, Feeling hot
Maltese: Mhux komuni: Irritazzjoni fil-post tal-injezzjoni, Uġigħ filpost tal-injezzjoni, Sħana
English: Total injection volume should be no greater than 1.0 mL and no less than 0.1 mL.
Maltese: Ilvolum totali ta' injezzjonijiet ma għandux ikun akbar minn 1.0 mL u mhux inqas minn 0.1 mL.
English: approximately 0.5 to 1.8% of the dose is accumulated in draining lymph nodes through specific binding after 30 minutes.
Maltese: 0.5 sa 1.8% tad-doża tinġabar fin-nodi limfatiċi ta' tbattil permezz ta' twaħħil speċifiku wara 30 minuta.
English: In Phase 3 clinical studies, technetium Tc 99m tilmanocept was detectable in sentinel lymph nodes within 10 minutes.
Maltese: Fi studji kliniċi tal-Fażi 3, technetium Tc 99m tilmanocept seta' jinstab fin-nodi limfatiċi sentinelli fi żmien għaxar minuti.
English: For the highest radiochemical purity, reconstitute with freshly eluted technetium Tc 99m generator eluate.
Maltese: Għallogħla purità radjukimika, irrikostitwixxi b'elużjoni ta' ġeneratur technetium Tc 99m elwita friska.
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the radiolabelled product.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għal kwalunkwe wieħed mill-komponenti tal-prodott radjutikkettat.
English: Technetium Tc 99m tilmanocept binding is independent of tumour type or severity.
Maltese: Ittwaħħil ta' technetium Tc 99m tilmanocept ma jiddependix mit-tip jew mis-severità tat-tumur.
English: Count each half of the strip with a suitable radioactivity counting apparatus (dose calibrator or multichannel analyzer).
Maltese: Għodd kull nofs tal-istrixxa b'apparat apposta tal-għadd tar-radjuattività (kalibratur tad-dożi jew analizzatur b'diversi kanali).
English: 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%.
Maltese: Rigward l-istat patoloġiku ta' ġabra ta' nodi limfatiċi minn qtugħ sħiħ tan-nodi limfatiċi, technetium Tc 99m tilmanocept illokalizza tajjeb f'nodi limfatiċi li jipprevedu l-preżenza ta' tumur metastatiku fi 38 minn 39 pazjent, għal rata negattiva falza ta' 2.56%.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi talProdott, sezzjoni 4.2).
English: 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.
Maltese: Fi studju kliniku tal-Fażi 3 f'pazjenti b'karċinoma taċ-ċelloli skwamużi ġol-ħalq jew fil-ġilda, technetium Tc 99m tilmanocept illokalizza nodi limfatiċi sentinelli f'97.59% tal-pazjenti li saritilhom valutazzjoni tannodi limfatiċi.
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.
Maltese: Il-%ID tal-plażma għal kull gramma għal żewġ livelli ta' dożi laħaq ilmassimu fi 15-il minuta; il-valuri medji għad-dożi ta' 20 u 200 mikrogramma kienu 0.0104%/g ± 0.
English: Directions for radiolabelling the tilmanocept powder 50 micrograms vial with technetium Tc 99m general considerations
Maltese: Id-doża rrakkomandata hija 50 mikrogramma tilmanocept radjutikkettat b'technetium Tc 99m b'rata ta' 18.5
English: 5.1 Pharmacodynamic properties
Maltese: Proprjetajiet farmakodinamiċi
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).
Maltese: Fl-istudju tal-Fażi 1 fil-pazjenti b'melanoma, fit-tliet dożi kollha ttestjati (20, 100, u 200 mikrogramma) Lymphoseek ikklerja s-sit tal-injezzjoni b'kostanti ta' rata ta' eliminazzjoni fil-medda ta' 0.227/siegħa sa 0.396/siegħa, li rriżulta f'nofs ħajja tal-mediċina fis-sit tal-injezzjoni ta' 1.75 sa 3.05 siegħa).
English: The substance, tilmanocept, specifically binds to mannose binding receptor proteins (CD206) that reside on the surface of macrophages and dendritic cells.
Maltese: Is-sustanza, tilmanocept, teħel speċifikament ma' proteini riċetturi li jorbtu l-mannose (CD206) li jinstabu fuq il-wiċċ taċ-ċelloli makrofaġi u dendritiċi.
English: Intraoperative lymphatic mapping may begin as early as 15 minutes post injection.
Maltese: L-immappjar limfatiku bejn l-operazzjonijiet jista' jibda minn 15-il minuta wara l-injezzjoni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: GĦAMLA KWALITATTIVA
English: Do not store above 25°C.
Maltese: Taħżinx il-mediċina f'temperatura ta' aktar minn 25°C.
English: This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Maltese: Dan ir-radjufarmaċewtiku jwassal ammonti baxxi ta' radjazzjoni jonizzanti assoċjata mal-iċken riskju ta' kanċer u anormalitajiet ereditarji.
English: b Blood represents total body exposure segregated from independent measurements of other organs and tissues.
Maltese: b Id-demm jirrappreżenta l-esponiment tal-ġisem sħiħ isseparata minn kejl indipendenti ta' organi u tessuti oħrajn.
English: Store using appropriate radiation shielding.
Maltese: Mhux applikabbli.
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).
Maltese: Lymphoseek huwa radjufarmaċewtiku mmirat għar-riċetturi li huwa mfassal sabiex jgħaddi malajr mill-vini limfatiċi; huwa jimmira b'mod bijoloġiku, jakkumula, u jinżamm f'nodi limfatiċi primarji u ewlenin ta' previżjoni u li joskulaw (nodi limfatiċi sentinelli).
English: • wound pain, wound opening or accumulation of fluid at surgical site
Maltese: • uġigħ fil-ferita, ftuħ tal-ferita jew akkumulazzjoni ta' fluwidu fis-sit tal-intervent kirurġiku
English: No dose adjustment is recommended based on age.
Maltese: Mhumiex irrakkomandati aġġustamenti tad-doża abbażi tal-età.
English: • if you have experienced any signs of allergic reaction (listed in section 4) after previous admistration of Lymphoseek
Maltese: • jekk kellek sinjali ta' reazzjoni allerġika (imniżżla f'sezzjoni 4) wara għoti preċedenti ta'
English: Other medicines and Lymphoseek
Maltese: Mediċini oħra u Lymphoseek
English: External imaging and intraoperative evaluation may be performed using a gamma detection device.
Maltese: It-teħid ta' immaġnijiet esterni u l-valutazzjoni bejn operazzjoni u oħra jistgħu jsiru permezz ta' apparat ta' detezzjoni bir-raġġi gamma.
English: • irritation or pain where the injection is given (including the breast and skin)
Maltese: • irritazzjoni jew uġigħ fejn tingħata l-injezzjoni (inkluż is-sider u l-ġilda)
English: Technetium Tc 99m labelling reactions depend on maintaining the stannous ion in the reduced state.
Maltese: Ir-reazzjonijiet għat-tikkettar ta' technetium Tc 99m jiddependu miż-żamma tal-jon stannjuż fi stat imnaqqas.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 and 12.
Maltese: Dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn ħlief dawk imsemmija f'sezzjoni 6.6 u 12.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Maltese: Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata
English: Store the vial in the outer carton in order to protect from light.
Maltese: Waħħal it-tikketta fuq il-kontenitur ta' protezzjoni.
English: Use only eluate from technetium Tc 99m generator which was previously eluted within 8 hours.
Maltese: MBq technetium Tc 99m prodott radjutikkettat.
English: Unopened vial
Maltese: Doża eċċessiva
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,
Maltese: Fi studji in vitro, technetium Tc 99m tilmanocept wera twaħħil speċifiku u sod mar-riċetturi CD206 talbniedem b'affinità ewlenija fis-sit ta' twaħħil ta' Kd = 2.76 x x 10-11 M.
English: 5 x 0.1 mL injections, or 2 x 0.25 mL injections, or 1 x 0.5 mL injection
Maltese: 5 injezzjoniijiet ta' 0.1 mL kull waħda, jew
English: These measures will help protect the environment.
Maltese: l. Aħżen il-prodott radjutikkettat f'kontenitur ta' protezzjoni.
English: Additional tracing agents should not be injected within 30 minutes of Lymphoseek administration.
Maltese: Sustanzi oħrajn ta' traċċar ma għandhomx ikunu injettati fi żmien 30 minuta mill-għoti ta' Lymphoseek.
English: Individual injection volumes should not exceed 0.5 mL or be less than 0.1 mL.
Maltese: Il-volumi ta' injezzjonijiet individwali ma għandhomx jaqbżu 0.5 mL jew ikunu inqas minn 0.1 mL.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: For instructions for preparation and control of the radiochemical purity of the radiopharmaceutical, see section 12.
Maltese: Għal istruzzjonijiet fuq it-tħejjija u l-kontroll tal-purità radjukimika tar-radjufarmaċewtiku, ara sezzjoni 12.
English: The lymph nodes nearest the tumour are called ‘sentinel' lymph nodes.
Maltese: In-nodi limfatiċi li jkunu l-aktar viċin it-tumur jissejħu nodi limfatiċi ‘sentinelli'.
English: The complete SmPC of Lymphoseek is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Maltese: L-SmPC sħiħ ta' Lymphoseek huwa pprovdut bħala sezzjoni li tista' tinqata' barra fl-aħħar tal-fuljett stampat fil-pakkett tal-prodott, bl-għan li jipprovdi lill-professjonisti fil-kura tas-saħħa aktar informazzjoni xjentifika u prattika dwar l-għoti u l-użu ta' dan ir-radjufarmaċewtiku.
English: g. Remove the needle, gently swirl the vial to mix the contents, and then let it stand at room temperature for at least 15 minutes.
Maltese: Oħroġ il-labra, dawwar il-kunjett bil-mod biex tħallat il-kontenut, u mbagħad ħallieh joqgħod f'temperatura ambjentali għal mill-inqas 15-il minuta.
English: 6.3 Shelf life
Maltese: TAGĦRIF
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The recommended minimum time for imaging is 15 minutes post injection.
Maltese: Il-ħin minimu rrakkomandat għat-teħid tal-immaġnijiet huwa ta' 15-il minuta wara l-injezzjoni.
English: Clinical studies have evaluated the incidence of adverse reactions listed below in 553 subjects 18 years and above who received Lymphoseek.
Maltese: Fi provi kliniċi b'553 pazjent, l-aktar reazzjonijiet avversi komuni kienu:
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Hefiya jiġi injettat taħt il-ġilda (użu għal taħt il-ġilda).
English: Tuberculosis (TB)
Maltese: Tuberkulożi (TB)
English: Investigations*
Maltese: Investigazzjonijiet *
English: Age over 65 years
Maltese: Età ta' aktar minn 65 sena
English: PROBABILITY OF NO FLARE
Maltese: PROBABILTA' TA' ‘NO FLARE'
English: • impotence;
Maltese: • impotenza;
English: See “4.
Maltese: Ara “4.
English: No data are available.
Maltese: M'hemm l-ebda data disponibbli.
English: Citric acid monohydrate Sodium chloride
Maltese: Citric acid monohydrate Sodium chloride Mannitol
English: (see section 4.4).
Maltese: (ara sezzjoni 4.4).
English: Alternative Storage:
Maltese: Ħażna Alternattiva:
English: • intestinal infections (including gastroenteritis);
Maltese: • infezzjonijiet intestinali (inkluża gastroenterite);
English: These include:
Maltese: *Nota:
English: b 2-sided p value from log rank test.
Maltese: 2-naħat valur P minn test log rank.
English: Tuberculosis
Maltese: Tuberkulożi
English: This is normal.
Maltese: Dan huwa normali.
English: Figure H).
Maltese: Figura F).
English: • multiple sclerosis;
Maltese: • sklerosi multipla;
English: Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Maltese: Ir-rispons kliniku (CR-100) kien mantenut f'102 u 233 pazjent, rispettivament.
English: 6336 Langkampfen Austria
Maltese: 6336 Langkampfen L-AWSTRIJA
English: placebo / MTX
Maltese: plaċebo /MTX
English: Treatment
Maltese: Trattament
English: -56.2a a p < 0.001, adalimumab vs. placebo
Maltese: -56.2a a p < 0.001, adalimumab kontra plaċebo
English: 4 to 7 years
Maltese: Minn 4 sa 7 snin
English: p value*
Maltese: valur P *
English: Sarcoidosis1), vasculitis
Maltese: Sarcoidosis1), infjammazzjoni vaskulari
English: PGA-F clear / minimal and ≥ 2-grade improvement (%)
Maltese: PGA-F xejn/minimali u ≥2-grad ta' titjib (%)
English: − The active substance is adalimumab.
Maltese: − Is-sustanza attiva hi adalimumab.
English: System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi