FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Maltese: L-ebda aġġustament fid-doża ma huwa meħtieġ għall-pazjenti b'indeboliment ħafif tal-kliewi (CLcr ≥50 u <80 mL/min).
English: Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate.
Maltese: Ipokalċimija li tkun klinikament rilevanti għandha tkun ittrattata permezz ta' amministrazzjoni ġol-vina ta' calcium gluconate.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Maltese: U KWANTITATTIVA Kunjett wieħed b'2 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 2 mg ibandronic acid (bħala sodium monohydrate).
English: Pyrexia, influenza-like illness**, oedema peripheral, asthenia, thirst
Maltese: Deni, marda li tixbaħ lillinfluwenza**, edima periferali, astenja, għatx
English: The dose should be infused over at least 15 minutes.
Maltese: Id-doża għandha tiġi infuża fuq medda ta' mill-inqas 15-il minuta.
English: As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Maltese: Hekk kif il-funzjoni renali tonqos bl-eta', dan huwa l-uniku fattur li għandu jiġi kkunsidrat (ara sezzjoni indeboliment tal-kliewi).
English: • Keep this medicine out of the sight and reach of children• Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna li tintewa u fuq it tikketta wara EXP.
English: Dosage: Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Maltese: Id-doża rakkomandata għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam hija ta' 6 mg bħala injezzjoni ġol-vini li tingħata kull 3-4 ġimgħat.
English: Excipients with known effect Bondronat is essentially sodium free.
Maltese: Eċċipjenti b'effett magħruf Bondronat huwa essenzjalment mingħajr sodium.
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Bondronat.
Maltese: Jekk qed tirċievi trattament dentali jew ser tagħmel kirurġija dentali (eż. qlugħ ta' snien), għarraf littabib tiegħek dwar it-trattament dentali tiegħek u għid lid-dentist tiegħek li qed tiġi ttrattat b'Bondronat.
English: The safety and efficacy of Bondronat in children and adolescents below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Bondronat fit-tfal u l-adolexxenti b'età inqas minn 18-il sena ma ġewx stabbiliti.
English: Urinary retention, renal cyst
Maltese: 3FR Ir-Renju Unit
English: Osteonecrosis of jaw†**
Maltese: Kwalità tal-Ħajja *
English: Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial with a bromobutyl rubber stopper).
Maltese: Bondronat huwa disponibbli f'pakketti li fihom kunjett wieħed (kunjett tal-ħġieġ ta' 2 ml tat-tip I b'għatu magħmul minn lastku bromobutyl).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/009
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/012/009
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Maltese: Kull kunjett fih 6 mg ta' ibandronic acid (bħala sodium monohydrate).
English: One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate)
Maltese: Kunjett wieħed b'6 ml ta' konċentrat għal soluzzjoni għall infużjoni fih 6 mg ibandronic acid (bħala sodium monohydrate)
English: • severe stomach pain.
Maltese: • għandek kanċer.
English: A statistically significant improvement in bone pain score was shown for Bondronat 50 mg compared to placebo.
Maltese: Titjib għall-aħjar fil-punteġg tal-uġigħ fl-għadam statistikament sinifikanti intwera għal Bondronat 50 mg meta mqabbel mal-plaċebo.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2).
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 mL/min) jew b'indeboliment sever tal-kliewi (CLcr <30 mL /min) li qed jiġu ttrattati għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u mard metastatiku tal-għadam huwa rakkomandat aġġustament fid-doża (ara sezzjoni 4.2).
English: In a study in 130 patients with metastatic breast cancer the safety of Bondronat infused over 1 hour or 15 minutes was compared.
Maltese: Fi studju f'130 pazjent b'kanċer metastatiku tas-sider, kienet imqabbla is-sigurtà ta' Bondronat mgħoti bħala infużjoni fuq medda ta' siegħa jew 15-il minuta.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 mL/min) jew b'indeboliment sever tal-kliewi (CLcr <30 mL/min) li qed jiġu ttrattati għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u mard metastatiku tal-għadam għandhom jiġu segwiti r-rakkomandazzjonijiet ta' dożaġġ li ġejjin:
English: One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate)
Maltese: Kunjett wieħed b'2 ml ta' konċentrat għal soluzzjoni għall infużjoni fih 2 mg ibandronic acid (bħala sodium monohydrate)
English: • Do not use this medicine after the expiry date which is stated on the folding box and on the label after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u l-kartuna wara EXP.
English: • stomach problems such as ‘gastroenteritis' or ‘gastritis'
Maltese: • problema fl-għajnejn imsejħa ‘kataretti'
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Bondronat in patients with concomitant risk factors.
Maltese: Eżami dentali b'dentistrija preventiva u stima tal-benefiċċju u r-riskju individwali huma rakkomandati qabel trattament b'Bondronat f'pazjenti li għandhom fatturi ta' riskju fl-istess waqt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2 mg of ibandronic acid (as sodium monohydrate).
Maltese: Kull kunjett fih 2 mg ta' ibandronic acid (bħala sodium monohydrate).
English: Benign skin neoplasm
Maltese: Jekk tinsa tieħu Bondronat
English: • Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Maltese: Skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadammiżjud ma' 100 ml ta' soluzzjoni isotonika ta' sodium chloride jew ma' 100 ml 5 % dextrose u infuż fuq medda ta' mill-anqas 15-il minuta.
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 Authorsation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: NAME OF THE MEDICINAL PRODUCT Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Maltese: TAL-PRODOTT MEDIĊINALI Bondronat 2 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Maltese: Il-farmakokinetika ta' ibandronic acid u l-bijodisponibilità huma simili kemm fl-irġiel kif ukoll finnisa.
English: Investigations Gamma-GT increased, creatinine increased
Maltese: Żieda f'gamma-GT, żieda filkrejatinina
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Bondronat (see section 4.2).
Maltese: Madankollu, skont l-eżami kliniku tal-pazjent individwali, huwa rakkomandat li jsir monitoraġġ talfunzjoni renali, tal-kalċju fis-serum, tal-fosfat u tal-manjesju f'pazjenti li jiġu trattati b'Bondronat (ara sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Maltese: TAL-PRODOTT MEDIĊINALI Bondronat 6 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: Batch
Maltese: Jew
English: In order to avoid potential incompatibilities, Bondronat concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Maltese: Sabiex jiġu evitati inkompatibilitajiet potenzjali, Bondronat konċentrat għal soluzzjoni għall-infużjoni għandu jitħallat biss ma' soluzzjoni isotonika ta' sodium chloride jew ma' soluzzjoni ta' 5 % dextrose.
English: Table 1 lists adverse reactions from 2 pivotal phase III studies (Prevention of skeletal events in patients with breast cancer and bone metastases: 286 patients treated with Bondronat 50 mg administered orally), and from post-marketing experience.
Maltese: III (Prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam: 286 pazjent ittrattat b'Bondronat 50 mg mogħti mill-ħalq), u minn esperjenza ta' wara t-tqegħid fis-suq.
English: While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Maltese: Waqt it-trattament, għandek iżżomm iġene orali tajba (inkluż ħasil regolari tas-snien) u tirċievi eżaminazzjonijiet dentali b'mod regolari.
English: A 15 minute infusion time has not been studied in cancer patients with a creatinine clearance of <50ml/min.
Maltese: Ħin tal-infużjoni ta' 15-il minuta ma ġiex studjat f'pazjenti tal-kanċer bi tneħħija tal-krejatinina ta' <50 ml/min.
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 minimization) 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: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Maltese: It-tneħħija mill-kliewi (madwar 60 ml/min f'nisa f'saħħithom li għaddew mill-menopawża) hija responsabbli għal 50-60 % tat-tneħħija totali u hija relatata mat-tneħħija tal-krejatinina.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see section 4.4.)
Maltese: Kienu rrappurtati każijiet ta' osteonekrosi tax-xedaq, il-biċċa l-kbira f'pazjenti bil-kanċer ittrattati bi prodotti mediċinali li jinibixxu l-assorbiment mill-ġdid tal-għadam, bħal ibandronic acid (ara sezzjoni 4.4.).
English: No difference was observed in the indicators of renal function.
Maltese: L-ebda differenza ma kienet osservata flindikaturi tal-funzjoni renali.
English: This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Maltese: Dan kien punt finali kompost li kellu l-episodji relatati mal-iskeletru (SREsskeletal related events) li ġejjin bħala sottokomponenti tiegħu:
English: Chest pain, influenza-like illness, malaise, pain
Maltese: Uġigħ fis-sider, marda li tixbaħ lill-influwenza, telqa, uġigħ
English: Clinical studies in the treatment of tumour-induced hypercalcaemia Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Maltese: L-ebda evidenza ta' tossiċità diretta fuq il-fetu jew effetti teratoġeniċi ma ġew osservati għal ibandronic acid fil-firien u fil-fniek ttrattati ġol-vina jew b'mod orali.
English: Bone pain *
Maltese: Infjammazzjo ni flgħajnejn†**
English: - Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases
Maltese: - prevenzjoni ta' avvenimenti skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jirrikjedu radjuterapija jew kirurġija) f'pazjenti b'kanċer tas-sider u metastasi fl-għadam
English: • you are a smoker (as this may increase the risk of dental problems)
Maltese: • tpejjep (għax dan jista' jżid ir-riskju ta' problemi dentali)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/012/011
English: For the prevention of skeletal events in patients with breast cancer and bone metastases, the Bondronat infusion is repeated at 3-4 week intervals.
Maltese: Għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam, linfużjoni ta' Bondronat hija ripetuta f'intervalli ta' 3-4 ġimgħat.
English: The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Maltese: L-inibizzjoni ta' assorbiment endoġenu tal-għadam ġiet dokumentata wkoll permezz ta' studji kinetiċi ta' 45Ca u r-reħa ta'
English: How to receive Bondronat
Maltese: X'fih Bondronat
English: Anaemia, blood dyscrasia
Maltese: Reazzjoni/xokk anafilattiku
English: A statistically significant improvement in bone pain score was shown for intravenous Bondronat 6 mg compared to placebo.
Maltese: Titjib għall-aħjar fil-punteġg tal-uġigħ fl-għadam statistikament sinifikanti intwera għal Bondronat 6 mg ġol-vina meta mqabbel mal-plaċebo.
English: While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Maltese: Filwaqt li fi provi kliniċi kkontrollati ma kienet osservata l-ebda żieda fir-riskju, bl-użu ta' bisfosfonati orali kien hemm rapporti ta' wara t-tqegħid fis-suq ta' ulċeri gastriċi u duwodenali, uħud severi u b'kumplikazzjonijiet.
English: use
Maltese: Tqala
English: Prevention of skeletal events in patients with breast cancer and bone metastases with Bondronat 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Maltese: Pożoloġija Id-doza rakkomandata hija pillola waħda miksija b'rita ta' 50 mg kuljum.
English: Water may be taken at any time during the course of Bondronat treatment (see section 4.5).
Maltese: Ilma jista' jittieħed f'kull ħin matul il-kors ta' trattament b'Bondronat (ara sezzjoni 4.5).
English: See the package leaflet for further information.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.
Maltese: Ipokalċemija (livelli baxxi ħafna ta' kalċju fis-serum) li tkun klinikament rilevanti għandha tkun ikkoreġuta permezz ta' amministrazzjoni ġol-vina ta' calcium gluconate.
English: Table 3 Secondary Efficacy Results (Breast cancer Patients with Metastatic Bone Disease)
Maltese: Tabella 3 Riżultati Sekondarji tal-Effikaċja (Pazjenti b'Kanċer tas-Sider b'Mard Metastatiku tal-Għadam)
English: Pregnancy
Maltese: Katarretta
English: Method and route of administration Bondronat concentrate for solution for infusion should be administered as an intravenous infusion.
Maltese: Il-metodu u rotta tal-amministrazzjoni Bondronat konċentrat għal soluzzjoni għall-infużjoni għandu jingħata bħala infużjoni ġol-vina.
English: Atypical subtrochanteric and diaphyseal femoral fractures†
Maltese: Ksur subtrochan teric u diaphyseal mhux tipiku talgħadma tal-wirk †
English: Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone.
Maltese: Ibandronic acid jappartjeni għall-grupp ta' komposti magħrufa bħala bisfosfonati li jaħdmu speċifikament fuq l-għadam.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/011: 1 vial
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/012/011: kunjett wieħed
English: No evidence of direct foetal toxicity or teratogenic effects was observed for ibandronic acid in intravenously or orally treated rats and rabbits.
Maltese: L-ebda evidenza ta' tossiċità diretta fuq il-fetu jew effetti teratoġeniċi ma ġew osservati għal ibandronic acid fil-firien u fil-fniek ittrattati ġol-vina.
English: • It helps to prevent other bone problems that may need surgery or radiotherapy Bondronat can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Maltese: • jekk għandek problemi fil-qalb u t-tabib irrakkomanda li tillimita l-konsum ta' fluwidu ta'
English: Blood alkaline phosphatase increase, weight decrease
Maltese: Żieda fl-alkaline phosphatase fiddemm, tnaqqis filpiż
English: In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
Maltese: Fil-bnedmin, il-volum apparenti tad-distribuzzjoni terminali huwa mill-inqas 90 l u l-ammont tad-doża li jilħaq l-għadam huwa stmat li huwa 40-50 % tad-doża fiċ-ċirkolazzjoni.
English: Osteoarthritis, myalgia, arthralgia, joint disorder, bone pain
Maltese: Osteoartrite, uġigħ filmuskoli, uġigħ fil-ġogi, disturb fil-ġogi, uġigħ fl-għadam
English: Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Maltese: Mhux hekk biss imma, peress li lgħaqda ta' ibandronic acid mal-proteini hija madwar 87 % f'konċentrazzjonijiet terapewtiċi, ipoprotejnimja f'mard sever fil-fwied x'aktarx ma twassalx għal żidiet ta' sinifikat kliniku filkonċentrazzjoni ħielsa fil-plażma.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 mL/min) huwa rakkomandat aġġustament fid-dożaġġ għal pillola waħda miksija b'rita ta' 50 mg, ġurnata iva u oħra le (ara sezzjoni
English: Clinical studies in the prevention of skeletal events in patients with breast cancer and bone metastases Clinical studies in patients with breast cancer and bone metastases have shown that there is a dose dependent inhibitory effect on bone osteolysis, expressed by markers of bone resorption, and a dose dependent effect on skeletal events.
Maltese: Studji kliniċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam urew li hemm effett inibitorju dipendenti mid-doża fuq l-osteolisi tal-għadam, espress b'markaturi ta' assorbiment tal-għadam, u effett dipendenti mid-doża fuq reazzjonijiet skeletriċi.
English: Frequency of administration
Maltese: Frekwenza tal-amministrazzjoni
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease) All Skeletal Related Events (SREs) Placebo n=158
Maltese: Tabella 2 Riżultati tal-Effikaċja (Pazjenti b'Kanċer tas-Sider b'Mard Metastatiku talGħadam)
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-EU Isem inventat Qawwa
English: Immediate Packaging Pack size
Maltese: Mnejn jingħata Il-pakkett
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LEUKOSCAN EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) LEUKOSCAN
English: When LeukoScan is radiolabelled, the radioactive compound technetium-99 (99mTc) becomes attached to sulesomab.
Maltese: Meta LeukoScan ikun radjutikkettat, il-kompost radjuattiv technetium-99 (99mTc) jeħel ma' sulesomab.
English: This summary was last updated in 02-2007.©EMEA 2007
Maltese: ©EMEA 2007
English: The active substance in LeukoScan, sulesomab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'LeukoScan, suleomab, hija anti-korp monoklonali.
English: The second study investigated LeukoScan in 130 patients with suspected long bone osteomyelitis.
Maltese: It-tieni studju investiga LeukoScan f'130 pazjent b'long bone osteomyelitis suspettata.
English: Rare side effects are eosinophilia (increase in eosinophils, a type of white blood cells) and facial rash.
Maltese: Effetti sekondarji rari huma eosinofilja (żieda fil-eosinofili, tip ta' ċelluli bojod tad-demm) u raxx talwiċċ.
English: Scintigraphy is a scanning method that uses a special camera (gamma camera) that can detect radioactivity.
Maltese: Sintigrafija hija metodu ta' scanning li juża kamera speċjali (kamera gamma) li tista' tikxef ir-radjuattività.
English: LeukoScan is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Maltese: LeukoScan huwa radjutikkettat billi jiġi mħallat ma' soluzzjoni ta' techmetium radjuattiv (99mTc).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for LeukoScan to Immunomedics GmbH on 14 February 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea, għal LeukoScan għal Immunomedics GmbH fl-14 ta' Frar 1997.
English: As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate where there is an infection, and it can be detected using special scanning techniques, such as scintigraphy or SPECT (single photon emission computed tomography).
Maltese: Hekk kif numru kbir ta' granuloċiti jinġabru fis-sit ta' injezzjoni, irradjuattività takkumula fejn ikun hemm infezzjoni u din tista' tinkixef bl-użu ta' tekniki speċjali ta' scanning, bħal sintigrafija jew SPECT (single photon emission computed tomography).
English: How has LeukoScan been studied?
Maltese: Kif ġie studjat LeukoScan?
English: LeukoScan was more effective than the standard technique of radiolabelled white blood cells, with a higher sensitivity (detection of 88% of the infections with LeukoScan, compared to 73% with the radiolabelled white blood cells).
Maltese: Intwera li LeukoScan huwa aktar effettiv mit-teknika standard ta' radjuttikkettar ta' ċelluli bojod radjutikkettati, b'sensittività ogħla (kxif ta' 88% ta' l-infezzjonijiet b'LeukoScan, imqabbel ma' 73% ta' ċelluli bojod tad-demm
English: Sulesomab has been designed to target an antigen called NCA90, which is present on the surface of granulocytes (a type of white blood cell).
Maltese: Sulesomab ġie iddisinjat biex jimmira antiġen magħruf bħala NCA90, li huwa preżenti fil-wiċċ ta' granuloċiti (tip ta' ċellula tad-demm bajda).
English: The first investigated LeukoScan in the detection of osteomyelitis in 102 patients with diabetic foot ulcers.
Maltese: L-ewwel investiga LeukoScan fil-kxif ta' osteomyelitis f'102 pazjenti b'ulċeri tas-saqjn dijabetiċi.
English: The marketing authorisation was renewed on 14 February 2002 and 14 February 2007.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fl-14 ta' Frar 2002 u fl-14 ta' Frar 2007.