FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Zentiva, whether or not you also have HIV.
Maltese: Jekk għandek HBV, hemm riskju serju ta' problemi tal-fwied meta tieqaf tieħu Emtricitabine/Tenofovir disoproxil Zentiva, kemm jekk għandek l-HIV jew le.
English: • pain, stomach pain,
Maltese: • sturdament, uġigħ ta' ras,
English: Therefore, the same problems may be seen if Emtricitabine/Tenofovir disoproxil Zentiva is administered with a third nucleoside analogue.
Maltese: Għalhekk, l-istess problema tista' tiġi osservata jekk Emtricitabine/Tenofovir disoproxil Zentiva jingħata ma' tielet analogu tan-nucleosides.
English: In vivo - treatment of HIV-1 In an open-label randomised clinical study (GS-01-934) in antiretroviral-naïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/ml at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
Maltese: HIV 1 tal-plażma fuq il-pazjenti kollha li kien ikkonfermat li kellhom RNA tal-HIV ta' > 400 kopja/mL f'ġimgħat 48, 96 jew 144, jew fiż-żmien tattwaqqif bikri tal-mediċina.
English: The bioequivalence of one emtricitabine/tenofovir disoproxil phosphate film-coated tablet with one emtricitabine 200 mg hard capsule and one tenofovir disoproxil 245 mg film-coated tablet was established following single dose administration to fasting healthy subjects.
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva fiha sodium Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull pillola, jiġifieri essenzjalment hija ‘mingħajr sodium'.
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Maltese: 032 u 0.087 fil-punteġġ Z tal-ispina lumbari, u -0.184 u -0.
English: • Emtricitabine/Tenofovir disoproxil Zentiva is used to treat Human Immunodeficiency
Maltese: • Emtricitabine/Tenofovir disoproxil Zentiva għandu jintuża dejjem flimkien ma' mediċini oħra għat-trattament tal-infezzjoni tal-HIV.
English: Do not take Emtricitabine/Tenofovir disoproxil Zentiva to reduce your risk unless you are confirmed to be HIV negative.
Maltese: Tiħux Emtricitabine/Tenofovir disoproxil Zentiva biex tnaqqas irriskju tiegħek sakemm ma jkunx ikkonfermat li inti negattiv għall-HIV.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect.
Maltese: • Aċidożi lattika (ammont żejjed ta' aċidu lattiku fid-demm) hu effett sekondarju rari iżda potenzjalment ta'theddida għall-ħajja.
English: • increased triglycerides (fatty acids), bile or sugar in the blood,
Maltese: • żieda ta' triglycerides (aċidi tax-xaħam), bile jew zokkor fid-demm,
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Maltese: Sa 30% tad-doża ta' emtricitabine u madwar 10% tad-doża ta' tenofovir tista' titneħħa permezz ta' dijaliżi tad-demm.
English: Cmin: ↑ 91% (↑ 74 to ↑ 110)
Maltese: Cmax: ↔ Cmin: ↑ 91% (↑ 74 għal ↑
English: P-valuea, b mITT Analysis Seroconversions / N Relative Risk Reduction (95% CI)b URAI Within 12 Weeks Prior to Screening, mITT Analysis Seroconversions / N Relative Risk Reduction (95% CI)b a P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Maltese: Tnaqqis fir-Riskju Relattiv (95% CI)b a Valuri P skont il-logrank test.
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to initiating Emtricitabine/Tenofovir disoproxil Zentiva for treatment of HIV-1 or for pre-exposure prophylaxis, and should be monitored during use as in adults (see above).
Maltese: Il-funzjoni tal-kliewi (it-tneħħija tal-kreatinina u l-fosfat fis-serum) għandha tiġi evalwata qabel ilbidu ta' Emtricitabine/Tenofovir disoproxil Zentiva għat-trattament tal-HIV-1 jew għall-profilassi ta' qabel l-esponiment, u għandha tiġi mmonitorjata waqt l-użu bħal fl-adulti (ara hawn fuq).
English: It is important not to stop taking Emtricitabine/Tenofovir disoproxil Zentiva without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir disoproxil Zentiva.
Maltese: Huwa importanti li ma tiqafx tieħu Emtricitabine/Tenofovir disoproxil Zentiva mingħajr ma tkellem lit-tabib tiegħek: ara sezzjoni 3, Tiqafx tieħu Emtricitabine/Tenofovir disoproxil Zentiva.
English: • That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
Maltese: • Li jekk anormalitajiet tal-għadam huma osservati jew issuspettati, allura għandha ssir konsultazzjoni ma' endokrinoloġista u/jew nefroloġista
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjoni ta' tenofovir fil-plażma li tirriżulta mill-għoti flistess ħin ta' tenofovir disoproxil, ledipasvir/sofosbivir u atazanavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Invented name Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package sizes EU/1/01/173/001 Vaniqa
Maltese: EU/1/01/173/001 EU/1/01/173/002
English: EU-Numbers
Maltese: Il-pakkett
English: Samsca is available as tablets (7.5, 15 and 30 mg).
Maltese: Samsca jiġi bħala pilloli (7.5, 15 u 30 mg).
English: Normal sodium levels are between 135 and 145 mmol/l.
Maltese: Livelli normali tas-sodju huma bejn 135 u 145 mmol/l.
English: Further information on Samsca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Samsca tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This overview was last updated in 06-2018
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'06-2018.
English: The active substance in Samsca, tolvaptan, is a ‘vasopressin-2 receptor antagonist'.
Maltese: Is-sustanza attiva f'Samsca, it-tolvaptan, hija “antagonista tarriċettur vasopressin-2”.
English: Other information about Samsca
Maltese: Informazzjoni oħra dwar Samsca
English: Samsca contains the active substance tolvaptan.
Maltese: Samsca fih is-sustanza attiva tolvaptan.
English: What are the risks associated with Samsca?
Maltese: X'inhuma r-riskji assoċjati ma' Samsca?
English: Samsca is a medicine for treating abnormally low levels of sodium in the blood in adults with a condition called ‘syndrome of inappropriate antidiuretic hormone secretion' (SIADH).
Maltese: Samsca huwa mediċina li tintuża għall-kura ta' livelli anormalment baxxi ta' sodju fid-demm f'adulti b'kundizzjoni msejħa “sindromu tas-sekrezzjoni inadegwata tal-ormon antidijuretiku” (SIADH).
English: By day 30, sodium had increased by an average of 7.4 mmol/l in patients who took Samsca, compared with 1.5 mmol/l in patients receiving placebo.
Maltese: Sal-jum 30, is-sodju kien żdied b'medja ta' 7.4 mmol/l f'pazjenti li ħadu Samsca, meta mqabbel ma' 1.5 mmol/l f'pazjenti li ħadu plaċebo.
English: As for all medicines, data on the use of Samsca are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Samsca hija ssorveljata kontinwament.
English: In patients with SIADH, sodium levels, which were around 129 mmol/l at the start of treatment, rose by an average of 4.8 mmol/l by day 4 in those who took Samsca, compared with 0.2 mmol/l in those who took placebo (dummy treatment).
Maltese: F'pazjenti b'SIADH, il-livelli ta' sodju, li kienu ta' madwar 129 mmol/l fil-bidu tal-kura, żdiedu b'medja ta' 4.8 mmol/l sal-jum 4 f'dawk li ħadu Samsca, meta mqabbel ma' 0.2 mmol/l f'dawk li ħadu plaċebo (kura finta).
English: The starting dose is 15 mg once a day.
Maltese: Id-doża tal-bidu hija ta' 15 mg darba kuljum.
English: Samsca must not be used in patients with anuria (an inability to pass urine), very low blood volume, low blood sodium levels with low blood volume, hypernatremia (abnormally high levels of sodium in the blood) or in patients who cannot perceive thirst.
Maltese: Samsca ma jistax jintuża f'pazjenti b'anurja (inabbiltà li jgħaddu l-awrina), b'volum baxx ħafna tad-demm, b'livelli baxxi ta' sodju fid-demm b'volum baxx tad-demm, ipernatremija (livelli anormalment għoljin ta' sodju fid-demm) jew f'pazjenti li ma jistgħux jipperċepixxu l-għatx.
English: For the full list of side effects reported with Samsca, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Samsca, ara l-fuljett ta' tagħrif.
English: A dose of 7.5 mg once a day can be used for patients at risk of excessively quick rise in blood sodium.
Maltese: Għal pazjenti f'riskju ta' żieda f'daqqa fis-sodju fid-demm tista' tintuża doża ta' 7.5 mg darba kuljum.
English: Side effects reported with Samsca are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Samsca huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa għallprotezzjoni tal-pazjenti.
English: This means that it blocks one type of receptor (target) to which the hormone vasopressin normally attaches itself.
Maltese: Dan ifisser li timblokka tip ta' riċettur (il-mira) li miegħu normalment jeħel l-ormon vasopressin.
English: Two studies involving 424 adults showed that Samsca is effective at increasing sodium levels in patients with low levels caused by SIADH and other conditions such as liver and heart problems.
Maltese: Żewġ studji li fihom ħadu sehem 424 adult urew li Samsca huwa effettiv biex iżid il-livelli ta' sodju f'pazjenti b'livelli baxxi kkawżati minn SIADH u kundizzjonijiet oħra bħal problemi tal-fwied u talqalb.
English: The most common side effects with Samsca (which may affect more than 1 patient in 10) are thirst, nausea (feeling sick) and sodium levels rising too quickly.
Maltese: L-effetti sekondarji l-aktar komuni b'Samsca (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) huma għatx, nawsja (tħossok ma tiflaħx) u żieda f'daqqa fil-livelli tas-sodju.
English: Samsca has been shown to be effective at increasing sodium levels, particularly in patients with SIADH.
Maltese: Samsca ntwera li huwa effettiv fiż-żieda tal-livelli tas-sodju, b'mod partikolari f'pazjenti b'SIADH.
English: How does Samsca work?
Maltese: Kif jintuża Samsca?
English: People with SIADH have an excessive amount of vasopressin, leading to decreased urine production and dilution of the blood.
Maltese: Persuni b'SIADH għandhom ammont eċċessiv ta' vasopressin, li jwassal għal tnaqqis fil-produzzjoni tal-awrina u dilwizzjoni tad-demm.
English: In SIADH, an excessive amount of the hormone vasopressin makes the patient produce less urine and thereby retain more water in the body, which dilutes the concentration of sodium in the blood.
Maltese: F'SIADH, ammont eċċessiv tal-ormon vasopressin iġiegħel lill-pazjent jipproduċi inqas awrina u b'hekk iżomm aktar ilma fil-ġisem, li jnaqqas il-konċentrazzjoni tas-sodju fid-demm.
English: How is Samsca used?
Maltese: Samsca?
English: Samsca received a marketing authorisation valid throughout the European Union on 3 August
Maltese: Samsca rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fit3 ta' Awwissu 2009.
English: PSA progression d
Maltese: Progressjoni ta' PSA d
English: Drammensveien 288 NO-0283 Oslo Norway
Maltese: Drammensveien 288 NO-0283 Oslo In-Norveġja
English: • 41% received bisphosphonates.
Maltese: • 41% irċivew bisphosphonates.
English: N = 541 Placebo N = 268 Xofigo N = 541 Placebo N = 268
Maltese: N = 541 Plaċebo N = 268 Xofigo N = 541 Plaċebo N = 268
English: Symptomatic skeletal event (SSE)
Maltese: Avveniment skeletriku sintomatiku (SSE)
English: Total ALP progression c
Maltese: Progressjoni totali ta' ALP ċ
English: Date of first authorisation: 13 November 2013 Date of latest renewal: 21 June 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Novembru 2013 Data tal-aħħar tiġdid: 21 ta' Ġunju 2018
English: (7.2 - NE)b
Maltese: (7.2 - NE
English: Hydrochloric acid, dilute
Maltese: Hydrochloric acid, dilwit
English: Interim analysis
Maltese: Analiżi interim
English: (12.9 - NE) 10.8 (7.9 - NE)
Maltese: (12.9 - NE) 10.
English: Each mL of solution contains 0.194 mmol (equivalent to 4.5 mg) of sodium.
Maltese: Kull mL ta' soluzjoni fih 0.194 mmol (ekwivalenti għal 4.5 mg) ta' sodium.
English: Water for injections, sodium citrate, sodium chloride, hydrochloric acid.
Maltese: Ilma għall-injezzjonijiet, sodium citrate, sodium chloride, hydrochloric acid.
English: b Hazard ratio (Xofigo over placebo) < 1 favours Xofigo.
Maltese: b Proporzjon ta' periklu (Xofigo fuq plaċebo) < 1 jiffavorixxi Xofigo.
English: Surgical intervention 9
Maltese: Intervent kirurġiku 9
English: DK factor  1100 kBq/mL
Maltese: Fattur DK  1100 kBq/mL
English: Combination with abiraterone and prednisone/prednisolone
Maltese: Kombinazzjoni ma' abiraterone u prednisone/prednisolone
English: Radium-223 is an alpha particle-emitter with a half-life of 11.4 days.
Maltese: Radium-223 jerħi partiċelli alpha b'half-life ta' 11.4 jiem.
English: The specific activity of radium-223 is 1.9 MBq/ng.
Maltese: L-attività speċifika ta' radium-223 hi ta' 1.9 MBq/ng.
English: The pharmacokinetics of radium-223 dichloride were linear in the activity range investigated (51 to 276 kBq/kg).
Maltese: Il-farmakokinetika ta' radium-223 dichloride kienet lineari fil-firxa ta' attività investigata (51 sa 276 kBq/kg).
English: • the mean age of patients was 70 years (range 49 to 90 years).
Maltese: • l-età medja tal-pazjenti kienet ta' 70 sena (firxa minn 49 sa 90 sena).
English: Figure 2: Kaplan-Meier overall survival curves (updated analysis)
Maltese: Kaplan-Meier ta' sopravivenza globali (analiżi aġġornata)
English: Clear, colourless isotonic solution with pH between 6.0 and 8.0.
Maltese: Soluzzjoni isotonika ċara, bla kulur b'pH bejn 6.0 u 8.0.
English: = Body weight (kg)  activity (55 kBq/kg body weight)
Maltese: = Piż tal-ġisem (kg)  attività (55 kBq/kg ta' piż tal-ġisem)
English: SSE composite endpoint a
Maltese: Punt aħħari kompost ta' SSE a
English: - The active substance is: radium Ra 223 dichloride (radium-223 dichloride).
Maltese: - Is-sustanza attiva hi: radium Ra 223 dichloride (radium-223 dichloride).
English: • 87% of patients enrolled had an ECOG performance status score of 0-1.
Maltese: • 87% tal-pazjenti rreġistrati kellhom punteġġ tal-istat ta' ħila ECOG ta' 0-1.
English: Xofigo contains sodium
Maltese: Xofigo fih sodium
English: For additional instructions on the use of the medicinal product, see sections 6.6 and 12.
Maltese: Għal istruzzjonijiet addizzjonali dwar l-użu tal-prodott mediċinali, ara sezzjonijiet 6.6 u 12.
English: During the treatment period, 83% of patients received luteinising hormone-releasing hormone (LHRH) agonists and 21% of patients received anti-androgens concomitantly.
Maltese: Matul il-perijodu ta' kura, 83% tal-pazjenti rċivew agonisti ta' luteinising hormone releasing hormone (LHRH) u 21% tal-pazjenti rċivew antiandroġeni fl-istess ħin.
English: At an interim analysis, an increased incidence of fractures (28.6% vs 11.4%) and reduced median overall survival (30.7 months versus 33.3 months, HR 1.195, 95% CI [0.950 - 1.505], p=0.13) was observed among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone compared to patients receiving placebo in combination with abiraterone acetate and prednisone/prednisolone.
Maltese: F'analiżi interim, kienu osservati żieda fl-inċidenza ta' ksur (28.6% vs 11.4%) u tnaqqis fis-sopravivenza globali medjana (30.7 xhur kontra 33.3 xhur, HR 1.195, CI ta' 95% [0.950-1.505], p=0.13) fost pazjenti li kienu qed jirċievu Xofigo flimkien ma' abiraterone acetate u prednisone/prednisolone meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo flimkien ma' abiraterone acetate u prednisone/prednisolone.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100).
English: Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.4).
Maltese: Xofigo huwa kontraindikat flimkien ma' abiraterone acetate u prednisone/prednisolone (ara sezzjoni 4.4).
English: Table 1: Adverse reactions reported in clinical trials in patients treated with Xofigo System Organ Class
Maltese: Tabella 1:Reazzjonijiet avversi rrappurtati fil-provi kliniċi f'pazjenti kkurati b'Xofigo Klassi tas-Sistemi u tal-Organi
English: Time to event data on ALP progression were supported by statistically significant advantage with respect to ALP normalisation and ALP responses at week 12.
Maltese: Dejta dwar iżżmien sal-avveniment dwar progressjoni ta' ALP ġiet appoġġata minn vantaġġ statistikament sinifikanti rigward normalizzazzjoni ta' ALP u rispons ta' ALP f'ġimgħa 12.
English: Xofigo is a therapeutic alpha particle-emitting pharmaceutical.
Maltese: Xofigo hu mediċina terapewtika li tarmi partiċelli alpha.
English: Cardiac electrophysiology / QT prolongation
Maltese: Elettrofiżjoloġija kardijaka / titwil ta' QT
English: Limited data are available for patients with moderate (CLCR: 30 to 50 mL/min) renal impairment.
Maltese: Hemm disponibbli dejta limitata għal pazjenti b'indeboliment moderat tal-kliewi (CLCR: 30 sa 50 mL/min).
English: Manufacturer Bayer AS
Maltese: Manifattur Bayer AS
English: Crohn's disease and ulcerative colitis
Maltese: Marda ta' Crohn u kolite ulċerattiva
English: ALP = alkaline phosphatase; CI = confidence interval; NE = not estimable; PSA = prostate-specific antigen;
Maltese: ALP = alkaline phosphatase; CI = intervall ta' kunfidenza; NE = ma jistax jiġi stmat; PSA = antiġen speċifiku għall-prostata;
English: Relative to placebo, the decline in quality of life was slower for Xofigo during the on-treatment period as measured by EQ-5D utility index score (-0.040 versus - 0.109; p=0.001), EQ-5D self-reported Visual Analogue health status scores (VAS) (-2.661 versus -5.860; p=0.018) and the FACT P total score (-3.880 versus -7.651, p=0.006) but did not reach published minimally important differences.
Maltese: Imqabbel malplaċebo, it-tnaqqis fil-kwalità tal-ħajja kien aktar bil-mod għal Xofigo matul il-perijodu ta' kura kif imkejjel mill-punteġġ tal-indiċi tal-utilità EQ-5D (-0.040 kontra - 0.109; p=0.001), punteġġi tal-istat ta' saħħa talAnalogu Viżiv (VAS - Visual Analogue health status scores) awto-rappurtat EQ-5D (-2.661 kontra -5.860; p=0.018) u l-punteġġ totali FACT P (-3.880 kontra -7.651, p=0.006) iżda ma laħqux differenzi importanti minimi ppubblikati.
English: Embryotoxicity / Reproduction toxicity
Maltese: Effett tossiku fuq l-embriju/Effett tossiku fuq is-sistema riproduttiva
English: Pharmacokinetic, biodistribution and dosimetry data were obtained in 6 patients at an activity of 110 kBq/kg given twice, 6 weeks apart, and in 10 patients at an activity of 55, 110 or 221 kBq/kg.
Maltese: Dejta farmakokinetika u dwar il-bijodistribuzzjoni u d-dożimetrija inkisbet minn 6 pazjenti f'attività ta' 110 kBq/kg mogħtija darbtejn, b'intervall ta' 6 ġimgħat, u minn 10 pazjenti f'attività ta' 55, 110 jew 221 kBq/kg.
English: Combination with abiraterone and prednisone/prednisolone or with systemic cancer therapies other than LHRH analogues
Maltese: Kombinazzjoni ma' abiraterone u prednisone/prednisolone jew ma' terapiji sistemiċi għall-kanċer minbarra analogi ta' LHRH
English: Figure 1: Radium-223 decay chain with physical half-lives and mode of decay:
Maltese: Figura 1: Katina ta' tnaqqis fil-potenza ta' Radium-223 b'half-lives fiżiċi u l-mod tat-tnaqqis filpotenza:
English: Xofigo 1100 kBq/mL solution for injection radium Ra 223 dichloride
Maltese: Xofigo 1100 kBq/mL soluzzjoni għall-injezzjoni radium Ra 223 dichloride
English: Best standard of care included e.g. local external beam radiotherapy, bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine or ketoconazole.
Maltese: L-aħjar standard ta' kura kien jinkludi pereżempju: radjuterapija b'raġġ lokali estern, bisphosphonates, kortikosterojdi, antiandroġeni, estroġeni, estramustine jew ketoconazole.
English: Distribution and organ uptake
Maltese: Distribuzzjoni u assorbiment mill-organi
English: This medicine contains the active substance radium Ra 223 dichloride (radium-223 dichloride).
Maltese: Din il-mediċina fiha s-sustanza attiva radium Ra 223 dichloride (radium-223 dichloride).
English: Xofigo 1100 kBq/mL solution for injection
Maltese: Xofigo 1100 kBq/mL soluzzjoni għall-injezzjoni
English: A statistically significant overall survival benefit of treatment could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.553 -1.466], p=0.674) or a baseline total alkaline phosphatase (ALP) < 220 U/L (HR 0.823; 95% CI [0.633 -1.068], p=0.142) in the phase III ALSYMPCA study.
Maltese: Ma jistax jintwera benefiċċju ta' sopravivenza globali statistikament sinifikanti fis-sottogruppi ta' pazjenti b'inqas minn 6 metastasi (HR għal radium-223 għal plaċebo 0.901; CI ta' 95% [0.553-1.466], p=0.674) jew alkaline phosphatase (ALP) totali fil-linja bażi (ALP) < 220 U/L (HR 0.823; CI ta' 95% [0.
English: d Defined as a ≥ 25% increase and an increase in absolute value of ≥ 2 ng/mL compared to baseline/nadir.
Maltese: d Definit bħala żieda ta' ≥ 25% u żieda fil-valur assolut ta' ≥ 2 ng/mL meta mqabbel mal-linja bażi/livell minimu.
English: Compared with placebo, there was a significant difference in favour of Xofigo for all five serum biomarkers for bone turnover studied in a phase II randomised study (bone formation markers: bone alkaline phosphatase [ALP], total ALP and procollagen I N propeptide [PINP], bone resorption markers: C-terminal crosslinking telopeptide of type I collagen / serum C-terminal crosslinked telopeptide of type I collagen [S-CTX-I] and type I collagen crosslinked C-telopeptide [ICTP]).
Maltese: II li fih il-parteċipanti ntgħażlu b'mod każwali (markaturi tal-formazzjoni tal-għadam: alkaline phosphatase [ALP] tal-għadam, ALP totali u procollagen I N propeptide [PINP], markaturi tal-assorbiment mill-ġdid tal-għadam: C-terminal crosslinking telopeptide ta' collagen ta' tip I / C-terminal crosslinked telopeptide ta' collagen ta' tip I fis-serum [S-CTXI] u crosslinked C-telopeptide [ICTP] ta' collagen ta' tip I).
English: Uterine polyps (endometrial stroma) were observed in female rats after single or repeated administration of ≥ 359 kBq/kg body weight radium-223 dichloride (≥ 6.5 times the clinically recommended activity).
Maltese: Ġew osservati polipi fl-utru (stroma endometrijali) f'firien nisa wara għoti ta' darba jew għoti ripetut ta' ≥ 359 kBq/kg ta' piż tal-ġisem ta' radium-223 dichloride (≥ 6.5 darbiet lattività rrakkomandata klinikament).
English: Calculations of absorbed doses were performed using OLINDA/EXM (Organ Level INternal Dose Assessment/EXponential Modeling), a software based on the Medical Internal Radiation Dose (MIRD) algorithm, which is widely used for established beta and gamma emitting radionuclides.
Maltese: Kalkoli ta' dożi assorbiti saru bl-użu ta' OLINDA/EXM (Organ Level INternal Dose Assessment/EXponential Modeling), programm elettroniku ibbażat fuq l-algoritmu tad-Doża ta' Radjazzjoni Interna Medika (MIRDMedical Internal Radiation Dose), li jintuża ħafna għal radjunukleidi stabbiliti li jarmu partiċelli beta u gamma.
English: • 42% of patients did not receive prior docetaxel because they were deemed ineligible or refused to receive docetaxel.
Maltese: • 42% tal-pazjenti ma rċivewx docetaxel fil-passat għax ġew ikkunsidrati li ma kinux eliġibbli jew irrifjutaw li jirċievu docetaxel.
English: 1100 kBq/mL at 12 h (CET) ref. date: [DD/MM/YYYY] 6.6 MBq/vial at 12 h (CET) ref. date: [DD/MM/YYYY]
Maltese: 1100 kBq/mL wara 12-il siegħa (CET) data ta' ref: [JJ/XX/SSSS] 6.6