FrancophonIA/ELRC3.0 huggingface dataset:
English: Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle label for the presentations of 28, 98 and 500 film-coated tablets
Maltese: Kaxxa tal-kartun ta' daqsijiet ta' 28, 98 u 500 pilloli miksija b'rita fi fliexken HDPE / it-tikketta tal-flixkun HDPE għad-daqsijiet ta' 28, 98 u 500 pilloli miksija b'rita
English: Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets.
Maltese: Fliexken opaki u bojod tal-HDPE li fihom 28, 98 u 500 pillola miksija b'rita.
English: Experience in patients over 75 years and Orientals/Asians was limited.
Maltese: Lesperjenza hija limitata f'pazjenti 'l fuq minn 75 sena u f'nies Orjentali/Asjatiċi.
English: Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Maltese: (bħal ketoconazole, ritonavir, telithromycin, clarithromycin u nefazodone).
English: Hallucinations
Maltese: Alluċinazzjonijiet
English: Excipients:
Maltese: Sess:
English: In standard fertility studies in female rats (dosing for 2 weeks prior to mating) there was abnormal oestrous cyclicity and a decrease in corpora lutea and fertility index at doses of rimonabant that induced maternal toxicity (30 and 60 mg/kg/day).
Maltese: Fi studji ‘standard' fuq il-fertilità fil-firien ta' sess femminil, meta ngħataw dożi fil-ġimgħatejn qabel it-tgħammir, kien hemm ċikli abnormali fis-saħna sesswali u t-tnaqqis fil-corpora lutea u l-indiċi talfertilità, b'dożi ta' rimonabant li ikkaġunaw tossiċità lill-omm (30 sa 60 mg/kg/jum).
English: Generally ACOMPLIA 20 mg had no significant effect on Total-C or LDL-C levels.
Maltese: Bhala regola 20 mg ta' ACOMPLIA ma kellux effett fuq il-livelli totali ta' C jew ta' LDL-C.
English: Clinical study results
Maltese: Riżultati ta'studji kliniċi
English: − itraconazole (antifungal medicine)
Maltese: MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: The effect of renal function on the pharmacokinetics of rimonabant has not been studied specifically.
Maltese: L-effet tal-funzjoni renali fuq il-komportament farmakokinetiku ta' rimonabant ma kienx speċifikament studjat.
English: Although concomitant administration of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of efficacy.
Maltese: Għalkemm it-teħid ta' rimonabant flimkien ma' sustanzi li jistimulaw CYP3A4 (bħal rifampicin, phenytoin, phenobarbital, carbamazepine u St John's wort) ma ġiex studjat, huwa mistenni li l-użu konkomitanti ta' sustanzi li jinduċu CYP3A4, jistgħu jnaqqsu l-ammont ta' rimonabant fil-plażma u dan jirriżulta f'nuqqas ta' effikaċja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of rimonabant.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg ta' rimonabant.
English: Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4)
Maltese: Mard depressiv sever li għadu sejjer u/jew kura antidepressiva li għada sejra (ara sezzjoni 4.4)
English: A mean weight loss of 6.5 kg from baseline to one year was shown for ACOMPLIA 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3;-4.4, p< 0.001).
Maltese: Intwera telf medju ta' 6.5 kg fil-piż mil-linja bażi sa sena għal 20 mg ta' ACOMPLIA, kontra t-telf medju ta' 1.6 kg għall-plaċebo (Differenza -4.9 kg CI95% -5.3; -4.4, p<0.001).
English: Rimonabant should not be used in patients with severe renal impairment (see section 4.2 and 5.2).
Maltese: Rimonabant m'għandux jintuża f'pazjenti li għandhom indeboliment renali sever (ara sezzjoni 4.2 u 5.2).
English: ACOMPLIA 20 mg film-coated tablets (rimonabant)
Maltese: ACOMPLIA 20 mg pilloli miksija b'rita rimonabant
English: PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun magħmula ghal 14, 28, 30, 56, 70, 84, 90 u 98 pilloli miksija b'rita fil-folji
English: − Skin and subcutaneous tissue disorders: rash.
Maltese: - Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda: raxx.
English: Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant.
Maltese: Meta jingħataw sustanzi li jinduċu s-sistema CYP3A4 konkomitanti ma' rimonabant dan mistenni li jnaqqas l-espożizzjoni għal rimonabant.
English: Subjects with a 10% weight reduction Difference (CI 95%)
Maltese: Differenza (CI 95%) Suġġetti b'tnaqqis filpiż ta' 10%
English: As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).
Maltese: Bħala żieda mad-dieta u l-eżerċizzju fil-kura tal-obeżità f' pazjenti ħoxnin (BMI ≥ 30 kg/m2), jew pazjenti qawwija (BMI > 27 kg/m2) li għandhom ukoll fattur(i) miżjud(a) ta' riskju, bhad-dijabete tattip 2 jew livelli abnormali ta' xaħam fid-demm (ara sezzjoni 5.1).
English: Pharmaco-therapeutic group: Anti obesity agent ATC code: A08AX01
Maltese: A08AX01
English: Patients had a BMI ≥ 30 kg/m² or BMI > 27 kg/m² with hypertension and/or dyslipidemia at inclusion.
Maltese: BMI > 27 kg/m2, akkompanjat ma' pressjoni għolja tad-demm u/jew abnormalitajiet fil-livelli taxxaħmijiet fid-demm.
English: The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.
Maltese: Il-komportament farmakokinetiku ta' kontraċettiv orali (magħmul minn ethinyl estradiol/levonorgestrel ) meta jilħaq livelli kostanti fid-demm, ma kienx sinifikantement mibdul meta ngħata rimonabant fl-istess ħin.
English: Take special care with ACOMPLIA
Maltese: Waqgħa Kontużjoni Tfekkik ta' ġog
English: One film-coated tablet contains 20 mg rimonabant.
Maltese: Pillola waħda miksija b'rita fiha 20 mg rimonabant.
English: The potential for inhibition of CYP2C8 in vivo appears to be low.
Maltese: Il-potenzjal għall-inibizzjoni in vivo fuq CYP2C8 jidher li huwa baxx.
English: Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability; slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.
Maltese: Swied il-qalb, burdata depressiva; nuqqas ta'interess f'attivitajiet li qabel kienu jagħtu gost; aġitazzjoni; irritabilità ; inibizzjoni u dewmien biex tagħmel xi ħaġa; konċentrazzjoni baxxa; ansjetà; diffikultà biex torqod (insomnja); ħsibijiet jew kliem dwar mewt jew suwiċidju.
English: ACOMPLIA 20 mg film-coated tablets
Maltese: ACOMPLIA 20 mg pilloli miksija b'rita
English: In clinical studies, ACOMPLIA 20 mg was taken in the morning usually before breakfast.
Maltese: Fi studji kliniċi, 20 mg ta' ACOMPLIA ittieħdu filgħodu, normalment qabel il-kolazzjon.
English: • Diabetic patients
Maltese: • Pazjenti dijabetiċi
English: Based on a population pharmacokinetic analysis (age range 18 - 81 years) a 75 year old patient is estimated to have a 21% higher Cmax and a 27% higher AUC than a 40 year old patient.
Maltese: Meta saret l-analiżi farmakokinetika, ibbażata fuq popolazzjoni ta' 18-il sena sa 81 sena, pazjent ta' 75 sena huwa stmat li għandu 21% Cmax ogħla u 27% ogħla fl-AUC, meta mqabbel ma' pazjent ta' 40 sena.
English: Data are insufficient to draw conclusions regarding pharmacokinetics in moderate hepatic impairment.
Maltese: Id-data mhux biżżejjed li tippermetti li wieħed jasal għal konklużjonijiet rigward il-komportament farmakokinetiku f'indeboliment moderat tal-fwied.
English: Paediatrics:
Maltese: Tfal:
English: Memory loss Dizziness Hypoaesthesia Sciatica Paresthesia
Maltese: Nuqqas ta' memorja Sturdament Ipoestesija Xjatika Parasteżija
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni Disturbi psikjatriċi
English: At one year a mean weight loss of 5.3 kg was shown for ACOMPLIA 20 mg versus a loss on placebo of 1.4 kg (Difference -3.9 kg CI95% -4.6;-3.3 p<0.001).
Maltese: Wara sena, intwera tnaqqis medju fil-piż ta' 5.3 kg b'ACOMPLIA 20 mg meta mqabbel mat-tnaqqis ta' 1.4 kg bil-plaċebo (Differenza -3.9 kg CI95% -4.6;-3.3 p<0.001).
English: Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Maltese: Peress li l-pilloli ta' ACOMPLIA għandhom il-lattosju, pazjenti b'mard rari ereditarju ta' intolleranza ghall- galattosju, id-defiċjenza tal-lactase tat-tip Lapp jew in-nuqqas ta' assorbiment tal-glukosju u lgalattosju, m'għandhomx jieħdu din il-mediċina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/344/007
Maltese: FIS-SUQ EU/1/06/344/007
English: • Seizures
Maltese: • KUNDIZZJONIJIET OĦRA
English: The absolute change in HbA1c at one year was -0.6 for rimonabant 20 mg (baseline 7.3%) and +0.1 on placebo (baseline 7.2%).
Maltese: Il-bidla assoluta fil-livelli ta' HbA1c mat-tmiem lewwel sena kien ta' -0.6 b'20 mg rimonabant (linja bażi 7.3%) u +0.
English: A direct effect of rimonabant cannot be ruled out.
Maltese: Effett dirett ta' rimonabant ma jistax ikun eskluż.
English: Changes in HDL-C and TG in this population were similar to that of the non-diabetic population.
Maltese: Il-bidliet f'HDL-C u t-TG f'dan il-grupp ta' suġġetti kienu simili għal dawk li ma kienux dijabetiċi.
English: Suomi/Finland sanofi-aventis Oy Puh/Tel: +358 (0) 201 200 300
Maltese: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560
English: Depressive disorders Mood alterations with depressive symptoms Anxiety
Maltese: Mard depressiv Bidla fil-burdata b'sintomi depressivi Ansjetà
English: A similar increase in exposure is expected with other potent CYP3A4 inhibitors.
Maltese: Żieda simili fl-espożizzjoni hija mistennija b'inibituri oħra qawwija ta' CYP3A4.
English: Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg.
Maltese: Mard depressiv kien irrapportat f'3.2% tal-pazjenti, li kienu jbatu mill-obeżitza jew dawk kienu jiżnu aktar milli suppost u li kellhom fatturi miżjuda ta' riskju li kienu ittrattati b'20 mg ta' rimonabant.
English: However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8.
Maltese: Madankollu, ir-rimonabant kellu effett inibitorju ħafif fuq CYP2C8 in vitro.
English: Please inform your doctor or pharmacist if you are taking or have recently taken the above mentioned medicines or any other medicines, including those obtained without a prescription such as St John's wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), antidiabetes medicines and medicines to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) or depression.
Maltese: Jekk jogħgbok, għid lit-tabib jew lill-ispiżjar tiegħek jekk int qiegħed tieħu jew ħadt dan l-aħħar ilmediċini msemmija hawn fuq jew xi mediċini oħra, anki dawk mingħajr riċetta, bħal St John's wort, rifampicin (antibijotiku), mediċini biex tonqos fil-piż, mediċini biex tikkontrolla x-xaħmijiet fiddemm, mediċini għad-dijabete u mediċini biex tikkura l-epilessija (bħal phenytoin, phenobarbital, carbamazepine) jew id-depressjoni.
English: Tendonitis Muscle cramp Muscle spasms
Maltese: Infjammazzjoni ta' l-għerq Bugħawwieġ Spażmi muskolari
English: The potential relevance of this to administration of a CB1 antagonist is unknown.
Maltese: Ir-relevanza potenzjali ta' dan, għall-għoti ta' sustanza antagonistika għar-reċetturi CB1, mhux magħruf.
English: Experience with rimonabant in overdosage is limited.
Maltese: L-esperjenza b'rimonabant b'dożaġġi eċċessivi hija limitata.
English: The increased pup mortality might be attributable to a failure of the dam to nurse or ingestion of rimonabant in milk and/or inhibition of the suckling reflex that is reported in the literature to be initiated in neonatal mice by endocannabinoid signalling via CB1 receptors.
Maltese: Iż-zieda fil-mortalità tal-wild tista' tkun dovuta għan-nuqqas tattreddigħ mill-omm, jew il-preżenza ta'rimonabant fil-ħalib u/jew l-inibizzjoni ta' l-azzjoni riflessa tadtreddigħ, minn naħa tal-wild; din ta' l-aħħar hija irrapportata fil-letteratura xjentifika li tinbeda filġrieden tat-twelid, permezz ta' sinjali minn endocannabinoid diretti lejn ir-reċetturi CB1.
English: Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg. AUC increased less than in proportion to dose above 20 mg.
Maltese: Il-komportament farmakokinetiku hu pjuttost proporzjonali sa madwar 20 mg.
English: The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
Maltese: Din id-differenza filhalf-life hija dovuta għal differenzi fil-volum periferali ta' distribuzzjoni, bħala konsegwenza li ssuġġetti Ġappuniżi jiżnu anqas.
English: 174 Avenue de France F-75013 Paris France
Maltese: F-75013 Paris
English: Polska sanofi-aventis Sp. z o.o.
Maltese: Italia sanofi-aventis S.p.A.
English: The activity of ACOMPLIA is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:
Maltese: Il-kawtela hija irrakkomandata fl-użu simultanju ta' ACOMPLIA u inibituri qawwija ta' CYP3A4
English: In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo.
Maltese: Fi provi kliniċi, ma kienx hemm differenza fl-inċidenza ta' attakki epilettiċi f'pazjenti li rċevew rimonabant jew il-plaċebo.
English: The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥ 1%) or considered clinically relevant (for events < 1%).
Maltese: It-tabella li tmiss (tabella 1) turi r-reazzjonijiet avversi kollha, dovuti għat-trattament, minn studji ikkontrollati bil-plaċebo, f'pazjenti ittrattati għal telf fil-piż u mard ħafif metaboliku relatat, meta dawn kellhom inċidenza statistikament sinifikanti, akbar mir-rata korrispondenti bil-plaċebo, (għal grajjiet ta' ≥ 1%), jew ikkunsidrati klinikament rilevanti (għal grajjiet ta' < 1%)
English: Circulating metabolites do not contribute to its pharmacologic activity.
Maltese: Il-prodotti metaboliċi li jiċċirkulaw ma jikkontribixxux fuq l-attività farmakoloġika tiegħu.
English: Biconvex, teardrop-shaped, white tablets debossed with “20” on one side.
Maltese: Pilloli bojod, bikonvessi, taħt għamla ta' qatra dmugħ, bin-numru “20” imnaqqax fuq faċċata waħda.
English: Slovenija sanofi-aventis d.o.o.
Maltese: Franza sanofi-aventis S.p.A.
English: Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma levels of rimonabant.
Maltese: L-użu konkomitanti ta' orlistat, ethanol jew lorazepam ma' rimonabant ma kellux effett sinifikanti fuq il-livelli ta' rimonabant fil-plażma.
English: In obese patients, the elimination half-life is longer (about 16 days) than in non-obese patients (about 9 days) due to a larger volume of distribution.
Maltese: F' pazjenti li qed ibatu mill-obeżità, l'half-life ta' eliminazzjoni huwa itwal (madwar 16-il jum), minn pazjenti li mhumiex ħoxnin (madwar 9 ijiem), dovut għallvolum akbar ta' distribuzzjoni.
English: In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese and Caucasian subjects, whereas elimination half-life was shorter in Japanese subjects (3-4 days) compared to Caucasian subjects (about 9 days).
Maltese: Fi studji ibbażati fuq doża waħda u dawk repetuti, Cmax u l-AUC ta' rimonabant kienu simili f'suġġetti Ġappuniżi u Kawkasi b'saħħithom, filwaqt li l'half-life ta' eliminazzjoni kien iqsar f'suġġetti Ġappuniżi (3 - 4 ijiem), meta mqabbel ma' suġġetti Kawkasi (madwar 9 ijiem).
English: Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
Maltese: Disturbi depressivi jistgħu jkunu assoċjati ma' riskju akbar ta' ħsibijiet suwiċidali, li l-persuna tagħmel ħsara lilha innifisha u suwiċidju.
English: Rimonabant has not been studied in patients being treated for epilepsy.
Maltese: Ma kienux innotati malformazzjonijiet relatati mat-trattament fil-far.
English: Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 10 mg/kg/day.
Maltese: L-effetti ta' rimonabant fuq l-iżvilupp qabel u wara t-twelid kienu studjati fil-far f'dożi sa 10 mg/kg/jum.
English: In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with metformin or sulfonylurea improvements in HbA1c and body weight were observed.
Maltese: Fl-istudji investigattivi dwar il-pazjenti li kellhom id-dijabete tip 2 (RIO-Diabetes), u li kienu jiżnu aktar minn normal, jew kienu qed ibatu mill-obeżità, it-trattament bil-metformin jew bis-sulfonylurea ġew innotati titjib fil-HbA1c u fil-piż tal-ġisem .
English: For the triglycerides an average decrease of 6.9% was seen under rimonabant 20 mg (baseline TG 1.62 mmol/l) compared to an increase of 5.8% for placebo (baseline TG 1.65 mmol/l).
Maltese: TG 1.62 mmol/l), meta mqabbel ma' żieda ta' 5.8% bil-plaċebo (linja bażi
English: Only an approximate 3% of the dose of rimonabant is eliminated in the urine, while approximately 86% of the dose is excreted in the faeces as unchanged drug and metabolites.
Maltese: Madwar 3% biss tad-doża ta' rimonabant hija eliminata fl-urina, fil-waqt li madwar 86% tad-doża titneħħa fl-ippurgar, bħala s-sustanza mhux mibdula u bħala sustanzi metaboliċi.
English: At two years, the difference in total weight loss between ACOMPLIA and placebo was -4.2 kg (CI95% -5.0;3.4, p< 0.001).
Maltese: Fl-ahhar tas-sentejn iddifferenza fil-piż totali bejn ACOMPLIA u l-plaċebo kienet ta' -4.2 kg (CI95% -5.0;
English: NAME OF THE MEDICINAL PRODUCT ACOMPLIA 20 mg film-coated tablets rimonabant
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg ta' rimonabant
English: 70 x 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs.
Maltese: Għalkemm tossiċità fuq l-omm kienet irrapportata b'dawn id-dożi , ir-relazzjoni mat-trattament ma tistax tkun eskluża.
English: If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped.
Maltese: Terapija b'rimonabant mhux irrakkomandata f'pazjenti b'mard psikjatriku mhux kontrollat.
English: Population pharmacokinetic analysis demonstrated less fluctuation in peak to trough plasma concentration but no differences in steady state AUC as weight increases.
Maltese: L-analiżi tal-komportament farmakokinetiku fi grupp ta' persuni wera anqas varjazzjoni fl-ogħla (peak) u fl-anqas (trough) livelli fil-plażma, iżda ma kienx hemm differenzi meta stabiliżża l-AUC, hekk kif il-piż jiżdied.
English: Regarding reproductive parameters, at 30 mg/kg no differences were observed between treated animals and controls, at 60 mg/kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
Maltese: Firrigward tal-parametri riproduttivi, f'doża ta' 30 mg/kg, ma kienux innotati xi differenzi bejn lannimali ittrattati u dawk li ma kienux.
English: Hiccups
Maltese: Fwawar
English: Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant cognitive or sedative effect.
Maltese: Investigazzjonijiet konoxxittivi fi studju tal-farmakoloġija klinika urew li rimonabant m'għandu ebda effett sinifikanti ta' natura konoxxittiva jew sedattiva.
English: 1 Canadian Laboratory Initiative on PEdiatric Reference Intervals, http://www.caliperdatabase.com/caliperdatabase/controller?op=menu_reference_intervals&sm=0, accessed 29/08/2013
Maltese: 1 Canadian Laboratory Initiative on PEdiatric Reference Intervals (Inizjattiva tal-Laboratorju Kanadiż dwar l-Intervalli ta' Referenza Pedjatrika), http://www.caliperdatabase.com/caliperdatabase/controller?op=menu_reference_intervals&sm=0, aċċessat fid-29/08/2013
English: The magnesium content of Numeta G13%E is 0.43mmol/100mL.
Maltese: Il-kontenut tal-manjesju ta' Numeta G13%E huwa ta' 0.43mmol/100mL.
English: Numeta G13%E and Numeta G16%E are industrially manufactured, heat sterilised parenteral nutrition solutions (glucose, lipids, amino acids and electrolytes).
Maltese: Numeta G13%E u Numeta G16%E huma soluzzjonijiet li jiġu sterilizzati bis-sħana, manifatturati b'mod industrijali, għan-nutrizzjoni parenterali (glukosju, lipidi, aċidi amminiċi u elettroliti).
English: Studies investigating levels of magnesium in preterm infants have reported higher levels of magnesium as compared to more mature newborn infants indicating that plasma magnesium may be inversely related to somatic maturity (Ariceta et al, 1995; Tsang et al, 1970).
Maltese: Studji li investigaw il-livelli ta' manjesju fi trabi prematuri rrapportaw livelli ogħla ta' manjesju meta mqabbla ma' trabi tat-twelid aktar maturi li jindika li l-manjesju fil-plasma jista' jkun inversament relatat mal-maturità somatika (Ariceta et al, 1995; Tsang et al, 1970).
English: The initial application for Numeta G13%E and Numeta G16%E was supported by a prospective, multicentre, non-comparative, open-label phase 3 study (Ped3CB/P01/06/MuB).
Maltese: L-applikazzjoni inizjali għal Numeta G13%E u Numeta G16%E kienet appoġġjata minn studju prospettiv, multiċentriku, mhux-komparattiv, b'tikketta miftuħa tal-fażi 3 (Ped3CB/P01/06/MuB).
English: At a maximal dose of 96.2 ml/kg/d Numeta G16%E delivers 0.3 mmol/kg/d of magnesium which is above the recommended levels.
Maltese: F'doża massima ta' 96.2 ml/kg/d Numeta G16%E jwassal 0.3 mmol/kg/d ta' manjesju li huwa ogħla millivelli rakkomandati.
English: Pursuant to Article 6(1)(d) of Regulation (EC) No 1901/2006 as amended, the PDCO's opinion on Numeta was sought in the context of this review.
Maltese: Skont l-Artikolu 6(1)(d) tar-Regolament (KE) Nru 1901/2006 kif emendat, fil-kuntest ta' din ir-reviżjoni intalbet l-opinjoni tal-PDCO dwar Numeta.
English: This magnesium intake with Numeta G13%E appears higher than the recommendation of the American Society of Parenteral and Enteral Nutrition (ASPEN) and ESPGHAN/ESPEN guidelines for preterm neonates (0.15 to 0.25mmol/kg/d and 0.13-0.25mmol/kg/d respectively).
Maltese: Dan it-teħid ta' manjesju b'Numeta G13%E jidher ogħla mirrakkomandazzjoni tas-Soċjetà Amerikan tan-Nutrizzjoni Parenterali u Enterali (ASPEN) u l-linji gwida talESPGHAN/ESPEN għal trabi tat-twelid twieldu qabel iż-żmien (0.15 għal 0.25mmol/kg/d u 0.130.25 mmol/kg/d rispettivament).
English: Magnesium serves several important functions in the human body; it is a co-factor for DNA and protein synthesis, oxidative phosphorylation, enzyme activity and regulation of parathyroid hormone secretion (Volpe, 2013; Ayuk & Gittoes, 2011; Shils et al, 1999).
Maltese: Il-manjesju jservi diversi funzjonijiet importanti fil-ġisem tal-bniedem; huwa ko-fattur għas-sinteżi tad-DNA u talproteini, il-fosforilazzjoni ossidattiva, l-attività enzimatika u jirregola t-tnixxija tal-ormon tal-paratirojde (Volpe, 2013; Ayuk & Gittoes, 2011;
English: No clinical symptoms relative to hypermagnesaemia have been reported with the use of Numeta G13%E or Numeta G16%E.
Maltese: L-ebda sintomi kliniċi relattivi għal ipermagnesimja ma kienu rrapportati bl-użu ta' Numeta G13%E jew b'Numeta G16%E.
English: Although glomerular immaturity does persist during
Maltese: Għalkemm l-immaturità glomerulari ma tippersistix matul l
English: The levels of magnesium reported in these case reports ranged mainly from 1.025mmol/L to > 1.5mmol/L with levels greater than 1.2mmol/L reported in 9 out of 14 cases while one case was reported as > 1.5mmol/L.
Maltese: Il-livelli ta' manjesju rrapportati f'dawn ir-rapporti ta' każijiet kienu jvarjaw prinċipalment minn 1.025mmol/L għal > 1.5mmol/L b'livelli akbar minn 1.2mmol/L irrapportati f'9 minn 14-il każ filwaqt li każ wieħed kien irrapportat bħala > 1.5mmol/L.