FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinical data are available in patients with hepatitis B co-infection.
Maltese: M'hemm l-ebda data klinika disponibbli f'pazjenti b'koinfezzjoni tal-epatite B.
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Maltese: In vivo, ġie osservat tnaqqis ta' 1014 % ta' tneħħija tal-kreatinina (frazzjoni tas-sekrezzjonijiet hija dipendenti fuq it-trasport ta' OCT2 u
English: Limited data are available regarding the use of dolutegravir during pregnancy.
Maltese: Hemm data disponibbli limitata dwar l-użu ta' dolutegravir waqt it-tqala.
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.56 times the 50 mg human clinical exposure based on AUC).
Maltese: L-għoti orali ta' dolutegravir lil fniek tqal b'dożi sa 1000 mg/kg kuljum minn jiem 6 sa 18 tal-ġestjoni ma wassalx għal effett tossiku fl-iżvilupp jew teratoġeniċità (0.56 darba l-50 mg esponiment kliniku tal-bniedem abbażi tal-AUC).
English: Don't stop unless your doctor tells you to.
Maltese: Imbagħad ħu d‑doża li jkun imissek tieħu bħas‑soltu.
English: The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
Maltese: L-esponimenti fil-Livelli Bla Effett Avvers Osservat (NOAELs) fuq l-embrijun u l-fetu fil-firien u l-fniek kienu rispettivament 15 u 70 darba ogħla mill-esponiment fil-bnedmin bid-doża rakkomandata ta' 25 mg darba kuljum
English: At baseline, in the pooled analysis, characteristics were similar between treatment arms with the median age of subjects of 43 years (28%, 50 years of age or older; 3%, 65 years of age or older), 22% female, 20% nonwhite and 77% were CDC Class A. Median CD+cell count was about 600 cells per mm3 with 11% having CD4+ cell count less than 350 cells per mm3.
Maltese: Fil-linja bażi, fl-analiżi miġbura, il-karatteristiċi kienu simili bejn iż-żewġ fergħat ta' kura bl-età medjana tal individwi ta' 43 sena (28 %, ta' età ta' 50 sena jew aktar; 3 %, ta' età ta' 65 sena jew aktar), 22 % nisa, 20 %
English: Changes in laboratory biochemistries
Maltese: Antibijotiċi macrolide
English: In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the CYP3A system.
Maltese: Esperimenti in vitro jindikaw li rilpivirine primarjament jgħaddi minn metaboliżmu ossidattiv medjat mis‑sistem a ta' C Y P3A .
English: Musculoskeletal and connective tissue disorders uncommon arthralgia myalgia
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi mhux komuni artralġja majalġja
English: • increase in triglycerides (a type of fat)
Maltese: • żieda fit-trigliċeridi (tip ta' xaħam)
English: 40 mg single dose taken 4 hours after rilpivirine
Maltese: doża waħda ta' 40 mg meħuda 4 sigħat qabel rilpivirine
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets.
Maltese: 30 pillola.
English: Gastrointestinal disorders very common nausea increased pancreatic amylase diarrhoea common abdominal pain vomiting flatulence increased lipase abdominal discomfort upper abdominal pain dry mouth
Maltese: Disturbi gastrointestinali komuni ħafna nawsja amylase pankreatika miżjuda dijarea komuni uġigħ addominali remettar gass fl-istonku lipase miżjuda skumdità fl-addome uġigħ addominali ta' fuq ħalq xott
English: • medicines called H2 receptor antagonists (for example cimetidine, famotidine, nizatidine, ranitidine) to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux).
Maltese: • mediċini msejħa antagonisti tar-riċettur H2 (pereżempju cimetidine, famotidine, nizatidine, ranitidine) biex jikkuraw ulċeri fl-istonku jew ulċeri intestinali jew jintużaw biex itaffu ħruq ta' stonku minħabba rifluss tal-aċidu).
English: Limited data is available in patients with hepatitis C co-infection.
Maltese: Hemm data disponibbli limitata f'pazjenti b'koinfezzjoni tal-epatite Ċ.
English: Hypersensitivity reactions
Maltese: sensittività eċċessiva.
English: • dabigatran etexilate, used to treat or prevent blood clots.
Maltese: • dabigatran etexilate, jintuża biex jikkura u jipprevjeni l-koagulazzjoni tad-demm.
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to primary mutations (excluding at Q148) in experiments with site directed mutants, dolutegravir susceptibility remains at or near wildtype level.
Maltese: Meta jiżdiedu lmutazzjonijiet elenkati bħala mutazzjonijiet assoċjati ma' inibitur ta' integrase sekondarju (għal raltegravir/elvitegravir) mal-mutazzjonijiet primarji (eskluż f'Q148) f'esperimenti bil-mutanti diretti lejn is sit, is-suxxettibbiltà ta' dolutegravir tibqa' fil-livell tip selvaġġ jew viċin tiegħu.
English: Juluca must not be taken with some other medicines (see ‘Do not take Juluca' earlier in section 2).
Maltese: Juluca m'għandux jittieħed ma' xi mediċini oħra (ara “Tiħux Juluca” aktar 'il fuq f'sezzjoni 2).
English: common decreased appetite increased triglycerides (fasted) Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood anxiety uncommon suicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness)
Maltese: Disturbi psikjatriċi komuni ħafna insomnja komuni ħolm anormali dipressjoni disturbi tal-irqad burdata dipressanti ansjetà mhux komuni formazzjoni ta' ħsieb biex jitwettaq suwiċidju jew tentattiv ta' suwiċidju (partikularment f'pazjenti bi storja preeżistenti ta' dipressjoni jew mard psikjatriku)
English: NNRTI
Maltese: Treddigħ
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Maltese: Dolutegravir jinibixxi HIV integrase billi jeħel mas-sit attiv ta' integrase u jimblokka l-pass tat-trasferiment tal-istrand tal-integrazzjoni ta' Deoxyribonucleic acid (DNA) retrovirali li huwa essenzjali għaċ-ċiklu ta'
English: Signs of osteonecrosis include:
Maltese: Sinjali ta' osteonekrożi jinkludu:
English: Effects on bone
Maltese: IIb u Fażi
English: Rilpivirine 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
Maltese: Rilpivirine 25 mg darba kuljum mhuwiex probabbli li jkollu effett klinikament rilevanti fuq l-esponiment ta'
English: (inhibition of CYP3A enzymes).
Maltese: CYP3A).
English: Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects.
Maltese: Il-farmakokinetika ta' dolutegravir hija simili bejn individwi b'saħħithom u infettati bl-HIV.
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Maltese: Dolutegravir ma kienx mutaġeniku jew klastoġeniku permezz ta' testijiet in vitro fil-batterja u ċ-ċelluli talmammiferi kolturati, u f'analiżi tal-mikronukleu tar-rodituri in vivo.
English: While the total dolutegravir concentration in plasma was similar, a 1.5- to 2-fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Maltese: Filwaqt li l-konċentrazzjoni totali ta' dolutegravir fil-plażma kienet simili, ġiet osservata żieda ta' 1.5 sa 2 f'esponiment mhux marbut ma' dolutegravir f'individwi b'indeboliment tal-fwied moderat meta mqabbel ma' kontrolli b'saħħithom.
English: Cardiovascular
Maltese: Antiarritmiċi
English: The PK variability of dolutegravir is low to moderate.
Maltese: PK ta' dolutegravir hija baxxa għal moderata.
English: HIV-1 RNA <50 copies/mL Treatment Difference* Virologic non response** Reasons Data in window not <50 copies/mL Discontinued for lack of efficacy Discontinued for other reasons while not <50 copies/mL Change in ART No virologic data at Week 48 window Reasons Discontinued study/study drug due to adverse event or death Discontinued study/study drug for other reasons Missing data during window but on study HIV-1 RNA <50 copies/mL by baseline covariates n/N (%)
Maltese: L-individwi ġew irreġistrati jekk kienu fuq l-ewwel jew it-tieni reġimenen antiretrovirali tagħhom bl-ebda storja ta' insuffiċjenza viroloġika, ma kellhom l-ebda reżistenza suspettata jew magħrufa għal xi antiretrovirali u kienu soppressati b'mod stabbli (HIV-1 RNA < 50 kopja/mL) għal tal inqas 6 xhur qabel l-iskrinjar.
English: Calcium supplements/ Dolutegravir1
Maltese: Supplimenti tal kalċju/Dolutegravir1
English: In serial passage with strain NL432-based site directed mutants at N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
Maltese: F'passaġġ serjali bil-mutanti diretti lejn is-sit ibbażati fuq ir razza NL432 f'N155H jew E92Q, ma ntweriet ebda għażla oħa ta' reżistenza (FC mhux mibdul madwar 1).
English: Co-administration of Juluca with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of Juluca.
Maltese: Effetti sekondarji oħra possibbli Nies li jkunu qed jieħdu terapija kombinata għall-HIV jistgħu jkollhom effetti sekondarji oħra.
English: Juluca is used to treat HIV in adults aged 18 years and over who are taking other antiretroviral medicines and whose HIV-1 infection is under control for at least 6 months.
Maltese: Juluca jintuża biex jikkura l-HIV f'adulti li jkollhom 18-il sena jew aktar li jkunu qed jieħdu mediċini antiretrovirali oħra u l-infezzjoni tagħhom tal-HIV-1 tkun taħt kontroll għal tal-inqas 6 xhur.
English: Juluca contains lactose
Maltese: Juluca fih il-lactose.
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase inhibitor experienced or infected with integrase inhibitor resistant virus by transmission.
Maltese: massimu ta' 1.93 darba, individwu kellu sostituzzjoni ta' integrase V151V/I polimorfika, b'FC massimu ta'
English: It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Maltese: Mhuwiex magħruf jekk dan kollu jew parti minnu huwiex dovut għal sustanza attiva mhux assorbita jew eskrezzjoni biljari tal-konjugat glucuronidate, li tista' tiġi ddegradata aktar biex jiġi ffurmat il-kompost ewlieni fil-lumen tal-imsaren.
English: From rilpivirine Phase III trials, in the week 48 pooled resistance analysis conducted with previously untreated patients, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
Maltese: III ta' rilpivirine, fl-analiżi ta' reżistenza miġbura ta' ġimgħa 48 li saret b'pazjenti li ma ġewx ikkurati preċedentement, 62 (minn total ta' 72) insuffiċjenza viroloġika fil-fergħa ta' rilpivirine kellhom data ta' reżistenza fil-linja bażi u meta seħħet l-insuffiċjenza.
English: In contrast, starting passage with mutants with mutation Q148H (FC 1), a variety of raltegravir associated secondary mutations accumulated with a consequent increase of FC to values >10.
Maltese: B'kuntrast, il-bidu b'passaġġ b'mutanti li għandhom mutazzjoni Q148H (FC 1), akkumulaw varjetà ta'
English: 2 years.
Maltese: 50 mg.
English: Total blood and plasma drug-related radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components.
Maltese: Il-proporzjonijiet totali fil-konċentrazzjoni ta' radjuattività relatata mal mediċina fil-plażma u fid-demm kellhom medja ta' bejn 0.441 sa 0.535, u dan jindika assoċjazzjoni minima ta' radjuattività mal-komponenti ċellulari tad-demm.
English: Juluca should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema).
Maltese: (inkluż, iżda mhux limitati għal, raxx severi jew raxx akkumpanjat minn żieda fl-enzimi tal-fwied, deni, telqa ġenerali, għeja, uġigħ fil-muskoli jew fil-ġogi, infafet, leżjonijiet fil-ħalq, konġuntivite, edema fil-wiċċ,
English: Co-administration of Juluca and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 1).
Maltese: L-għoti flimkien ta' Juluca u prodotti mediċinali oħra li jinibixxu dawn l-enzimi jista' jżid il-konċentrazzjoni fil-plażma ta' dolutegravir (ara Tabella 1).
English: Other possible side effects
Maltese: Effetti sekondarji rari
English: Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Juluca ma' dawn l-indutturi metaboliċi huwa kontraindikat (ara sezzjoni 4.3).
English: The single amino acid substitutions associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Maltese: K101P, Y181I u Y181V.
English: Rilpivirine-resistant strains were selected in cell culture starting from wild type HIV-1 of different origins and clades as well as NNRTI-resistant HIV-1.
Maltese: Rilpivirine wera wkoll attività antivirali kontra sensiela wiesgħa ta' iżolati primarji tal-grupp M tal-HIV-1
English: • stomach ache
Maltese: • burdata dipressa • ansjetà
English: Iron supplements/ Dolutegravir1
Maltese: Supplimenti tal ħadid/Dolutegravir1
English: Co-administration of Juluca with medicinal products that inhibit CYP3A may result in increased plasma concentrations of rilpivirine (see Table 1).
Maltese: L-għoti flimkien ta' Juluca ma' prodotti mediċinali li jinduċu CYP3A jista' jirriżulta f'konċentrazzjonijiet fil-plażma mnaqqsa ta'
English: Moderate and high fat meals increased the dolutegravir AUC(0-∞) by approximately 87% and Cmax by approximately 75%.
Maltese: Ikel b'xaħam moderat u għoli żied l-AUC(0-∞) ta' dolutegravir b'madwar 87 % u s-Cmax b'madwar 75 %.
English: Juluca must be taken with a meal to obtain optimal absorption of rilpivirine (see section 4.2).
Maltese: emodijaliżi jew dijaliżi peritoneali (ara sezzjoni 4.2).
English: Renal elimination of rilpivirine is negligible.
Maltese: dolutegravir u rilpivirine.
English: Reproductive toxicology studies
Maltese: TAL-PRODOTT MEDIĊINALI
English: Available toxicological data in animals has shown excretion of dolutegravir and rilpivirine in milk.
Maltese: Data tossikoloġika disponibbli f'annimali wriet li kien hemm l-eliminazzjoni ta' dolutegravir u rilpivirine fil-ħalib.
English: Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Maltese: L-għoti flimkien aktarx jikkawża tnaqqis sinifikanti fil-konċentrazzjonijiet ta' rilpivirine fil plażma (induzzjoni tal-enzimi ta' CYP3A).
English: 1 The interaction between dolutegravir and/or rilpivirine and the medicinal product was evaluated in a clinical study.
Maltese: L-interazzjoni bejn dolutegravir u/jew rilpivirine u l-prodott mediċinali ġiet evalwata fi studju kliniku.
English: Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay.
Maltese: mutazzjoni invertita Ames in vitro u fl-assaġġ tal-limfoma tal-ġurdien tal-klastoġeniċità in vitro.
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Maltese: il-metrika mg/kg jew mg/m2 hija xierqa għal determinati xierqa ta' kopertura tas-sigurtà għal dan l-effett tossiku.
English: What you need to know before you take Juluca 3.
Maltese: X'għandek tkun taf qabel ma tieħu Juluca 3.
English: NAME OF THE MEDICINAL PRODUCT Juluca 50 mg/25 mg film-coated tablets
Maltese: Juluca 50 mg/25 mg pilloli miksijin b'rita
English: The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Maltese: L-effett ta' rilpivirine bid-doża rakkomandata ta' 25 mg darba kuljum fuq l-intervall tal-QTcF ġie evalwata fi studju crossover, randomised, ikkontrollat bi plaċebo u b'mod attiv (moxifloxacin 400 mg darba kuljum)
English: If you forget to take Juluca
Maltese: L-għoti flimkien ta' Juluca
English: A risk for increases in dabigatran plasma concentrations cannot be excluded
Maltese: Ma jistax jiġi eskluż riskju għal żidiet filkonċentrazzjonijiet filplażma ta' dabigatran
English: Rifabutin, a medicine to treat some bacterial infections, can lower the amount of Juluca in your body and make it less effective.
Maltese: Rifabutin, mediċina li tikkura xi infezzjonijiet batteriċi, tista' tbaxxi l-ammont ta' Juluca f'ġismek u tagħmlu inqas effettiv.
English: Juluca has not been studied in patients on dialysis.
Maltese: Juluca ma ġiex studjat f'pazjenti fuq dijaliżi.
English: Organ/Tissue
Maltese: Organu/Tessut
English: GE Medical Systems Polska Sp. z o.o.
Maltese: GE Medical Systems Polska Sp. z o.o. Tel.:
English: Remaining organs Effective dose (mSv/MBq)
Maltese: Doża effettiva(mSv/MBq)
English: White matter - p pons and cc corpus callosum.
Maltese: Materja l-bajda - p pons u cc corpus callosum.
English: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA) Italy
Maltese: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA)
English: GE Healthcare Bio-Sciences, S.A.U.
Maltese: GE Healthcare Bio-Sciences, S.
English: Volume: xx.x mL
Maltese: Volum: xx.x mL
English: Otherwise it should be classified as negative (normal).
Maltese: Inkella għandha tiġi kklassifikata bħala negattiva (normali).
English: NO-0485 Oslo
Maltese: NO-0485
English: Vial No: xxx
Maltese: Kunjett Nr: xxx
English: Seibersdorf Laboratories, Seibersdorf Seibersdorf Labor GmbH Grundstuck Nr. 482/2 EZ98 KG 2444 Seibersdorf
Maltese: Seibersdorf Laboratories, Seibersdorf Seibersdorf Labor GmbH Grundstuck Nr. 482/2 EZ98 KG 2444
English: falling to 10 % at 180 minutes.
Maltese: 180 minuta.
English: Nucleis SA Allée du Six-Août, 8 4000 Liège Belgium
Maltese: Nucleis SAAllée du Six-Août, 8 4000 Liège
English: Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} Activity: YYYY MBq {at hh:mm} {Time Zone} on {dd-mm-yyyy}
Maltese: Attività: 400 MBq/mL fi {ss:mm} {Żona ta' ħin} nhar il- {jj-xx-ssss} Attività:
English: Advanced Accelerator Applications Technopole de l'Aube 14 rue Gustave Eiffel 10430 Rosières près Troyes France
Maltese: Advanced Accelerator Applications Technopole de l'Aube 14 rue Gustave Eiffel 10430
English: Table 1 List of adverse reactions System Organ Class
Maltese: Tabella 1 List ta' reazzjonijiet avversi Sistema tal-Klassifika tal--Organi
English: AAA, Colleretto Giacosa (TO) Advanced Accelerator Applications S.r.l.
Maltese: AAA, Colleretto Giacosa (TO) Advanced Accelerator Applications S.r.l. Via Ribes 5
English: Nr. 482/2 EZ98 KG 2444 Seibersdorf Austria
Maltese: Nr. 482/2 EZ98 KG 2444
English: The scan duration should typically be 20 minutes.
Maltese: Normalment, l-iskan għandu jdum 20 minuta.
English: Each mL of solution contains 55.2 mg of ethanol and 4.1 mg of sodium.
Maltese: Kull mL ta' soluzzjoni fih 55.2 mg ta' ethanol u 4.1 mg ta' sodju.
English: Radioactive material.
Maltese: Materjal radjuattiv.
English: Each dose contains up to 552 mg alcohol.
Maltese: Kull doża fiha sa 552 mg ta' alkoħol.
English: trgovina d.o.o Tel: + 386 2 4716300
Maltese: Biomedics M.B. trgovina d.o.o Tel: + 386 2 4716300
English: 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 (cannot be estimated from the available data).
Maltese: 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 magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Germany
Maltese: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Il-Finlandja ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, L-Italja Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Il-Ġermanja
English: 98 (42%) of the 232 patients had abnormal (positive) flutemetamol (18F) scans.
Maltese: 98 (42%) mill-232 pazjent kellhom skans bi flutemetamol (18F) mhux normali (pożittivi).
English: Instituto Tecnológico PET, SA. C/Manuel Bartolome Cossio 10 28040 Madrid
Maltese: C/Manuel Bartolome Cossio 10 28040
English: Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dodecahydrate Water for injections
Maltese: Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dodecahydrate Ilma għall-injezzjonijiet
English: Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections.
Maltese: Eċċipjenti: ethanol anidru, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, ilma għall-injezzjonijiet.
English: 20 minutes post-injection, 75% of the radioactivity in plasma was present as polar metabolites.
Maltese: F'20 minuta wara l-injezzjoni, 75% tar-radjuattività fil-plażma kienet preżenti bħala metaboliti polari.
English: At 180 minutes, 90% of the radioactivity was present in plasma in the form of polar metabolites.
Maltese: F'180 minuta, 90% tar-radjuattività kienet preżenti fil-plasma fil-forma ta' metaboliti polari.
English: Table 2 below shows the dosimetry as calculated using the OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential Modeling) software.
Maltese: It-Tabella 2 hawn taħt turi d-dożimetrija kif ikkalkolata bl-użu tas-softwer OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential Modeling) .
English: This medicinal product contains (7 vol %) of ethanol (alcohol), i.e. up to 552 mg (approximately 0.7 mL) per dose.
Maltese: Dan il-prodott mediċinali fih (7 vol %) ta' etanol (alkoħol), jiġifieri sa 552 mg (madwar 0.7 mL) kull doża.
English: GE Healthcare A.E Τηλ: + 30 (2)10 8930600
Maltese: Τηλ: + 30 (2)10 8930600
English: A positive scan indicates a moderate to frequent density.
Maltese: Sken pożittiv jindika densità moderata għal densità frekwenti.
English: The majority read sensitivity and specificity were 93% (95% CI: 81% to 99%) and 84% (95% CI: 64% to 96%), respectively.
Maltese: Il-maġġoranza ta' sensittività u speċifiċità interpretati kienet ta' 93% (CI ta' 95%: 81% sa 99%) u 84% (CI ta' 95%: 64% sa 96%), rispettivament.
English: The effective dose is approximately 5.9 mSv when the maximal recommended activity of 185 MBq of flutemetamol (18F) is administered.
Maltese: Doża effettiva hi madwar 5.9 mSv meta tingħata l-attività massima rakkomandata ta' 185 MBq ta' flutemetamol (18F).
English: Dose absorbed per activity administered [mGy/MBq]
Maltese: Doża assorbita għal kull attività mogħtija [mGy/MBq]
English: Axial (a), Sagittal (b) and coronal (c) views of a negative and positive flutemetamol (18F)
Maltese: Dehriet assjali (a), Sagittali (b) u koronali (ċ) ta' skans negattivi u pożittiv għal flutemetamol (18F) (xellug u lemin rispettivament).