FrancophonIA/ELRC3.0 huggingface dataset:
English: Intuniv 4 mg tablet
Maltese: Intuniv 4 mg pillola
English: See leaflet for further information.
Maltese: Aqra l-fuljett ta' għal aktar informazzjoni.
English: Guanfacine was not genotoxic in a variety of test models, including the Ames test and an in vitro chromosomal aberration test.
Maltese: Guanfacine ma kienx ġenotossiku f'varjetà ta' mudelli ta' ttestjar, li jinkludu t-test ta' Ames u t-test ta' aberrazzjoni kromosomali in vitro.
English: The recommended dose titration for children and adolescents is provided below (see tables 1 and 2).
Maltese: It-titrazzjoni rakkomandata tad-doża għal tfal u adolexxenti hi pprovduta hawn taħt (ara tabelli 1 u 2).
English: The blister strips comprise of 2 layers, a clear thermoformable rigid film which is laminated with PCTFE to a PVC backing to which a push-through aluminium foil is adhered.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih L-istrixxi bil-folji jikkonsistu minn 2 saffi, rita riġida thermoformable ċara, li hi laminata bil-PCTFE ma' PVC backing, li miegħu hemm imwaħħal push-through aluminium foil.
English: Formal pharmacokinetic studies for race have not been conducted.
Maltese: Ma twettqu l-ebda studji farmakokinetiċi formali dwar ir-razza.
English: Each 1 mg tablet contains 22.41 mg of lactose (as monohydrate).
Maltese: Kull pillola ta' 1 mg fiha 22.41 mg ta' lactose (bħala monohydrate).
English: Concomitant administration of guanfacine with OCT1 substrates with a similar Tmax (e.g., metformin) may result in increases in Cmax of these medicinal products.
Maltese: L-għoti konkomitanti ta' guanfacine ma' sottostrati ta' OCT1 b'Tmax simili (eż. metformin) jista' jirriżulta f'żidiet fis-Cmax ta' dawn il-prodotti mediċinali.
English: Renal and urinary disorders Enuresis
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Enuresi
English: 12.34mm x 6.10mm oblong shaped, green tablets debossed with ‘4MG' on one side and ‘503' on the other side.
Maltese: Pilloli tawwalin ta' 12.34 mm x 6.10 mm, ta' kulur aħdar, imnaqqxin b'4MG' fuq naħa waħda u ‘503' fuq in-naħa l-oħra.
English: Patients treated with CYP3A4 and CYP3A5 inhibitors/inducers CYP3A4/5 inhibitors have been shown to have a significant effect on the pharmacokinetics of guanfacine when co-administered.
Maltese: Intwera li inibituri ta' CYP3A4/5 għandhom effett sinifikanti fuq il-farmakokinetika ta' guanfacine meta jingħataw flimkien.
English: Substance dependence.
Maltese: Dipendenza fuq id-drogi.
English: Three hundred and thirty-seven patients aged 6-17 years were evaluated in the pivotal Phase 3 Study SPD503-316, to assess safety and efficacy of once-daily dosing (children:1-4mg/day, adolescents: 1-7 mg/day).
Maltese: Tliet mija u sebgħa u tletin pazjent li kellhom bejn 6-17-il sena, ġew evalwati fl-Istudju importanti ħafna SPD 503-316, ta' Fażi 3, biex jiġu evalwati s-sigurtà u l-effikaċja ta' dożaġġ ta' darba kuljum (tfal: 1-4 mg/jum, adolexxenti: 1-7 mg/jum).
English: Due to a lack of proper toxicokinetic data, comparison to human clinical exposure was not possible.
Maltese: Minħabba nnuqqas ta' dejta tossikokinetika adattata, ma kienx possibbli li jsir paragun ma' esponiment kliniku uman.
English: Concomitant administration of guanfacine with MATE1 substrates may result in increases in the plasma concentrations of these medicinal products.
Maltese: L-għoti konkomitanti ta' guanfacine ma' sottostrati ta' MATE1 jista' jirriżulta f'żidiet fil-konċentrazzjonijiet ta' dawn il-prodotti mediċinali fil-plażma.
English: By stimulating alpha 2A-adrenergic receptors, guanfacine reduces sympathetic nerve impulses from the vasomotor centre to the heart and blood vessels.
Maltese: Billi jistimula riċetturi alpha2A-adrenerġiċi, guanfacine inaqqas l-impulsi tan-nervaturi simpatetiċi miċ-ċentru vażomotorili lill-qalb u lill-vini/arterji tad-demm.
English: Study SPD503-307 was a 9-week, double-blind, randomised, placebo-controlled, dose-optimisation study with guanfacine (1-4 mg/day) conducted in children aged 6-12 years with ADHD and oppositional symptoms (n=217).
Maltese: Studju SPD503-307 kien studju li dam 9 ġimgħat, double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, dwar l-ottimizzazzjoni tad-doża bi guanfacine (1-4 mg/jum), li twettaq fi tfal li kellhom minn 6-12-il sena, b'ADHD u sintomi oppożizzjonali (n=217).
English: • Your daily dose will be between 1 and 7 mg depending on your age and how you respond to Intuniv, but not more that 7 mg.
Maltese: • Id-doża tiegħek ta' kuljum se tkun bejn 1 u 7 mg, skont l-età tiegħek u skont kif tirrispondi għal Intuniv, iżda mhux iktar minn 7 mg.
English: Intuniv contains lactose.
Maltese: Intuniv fih il-lactose.
English: Intuniv 1mg prolonged-release tablets Intuniv 2mg prolonged-release tablets Intuniv 3mg prolonged-release tablets Intuniv 4mg prolonged-release tablets
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: below).
Maltese: JIS.
English: Intuniv 4 mg pack sizes: 28 or 84 tablets.
Maltese: Daqsijiet tal-pakketti ta' Intuniv 4 mg: 28 jew 84 pillola.
English: Dose reduction may be required in patients with severe renal impairment (GFR 29-15 ml/min) and an end stage renal disease (GFR<15 ml/min) or requiring dialysis.
Maltese: It-tnaqqis fid-doża jista' jkun meħtieġ f'pazjenti b'indeboliment sever talkliewi (GFR 29-15 ml/min) u mard tal-kliewi fl-aħħar stadju (GRF<15 ml/min) jew li jkun jeħtieġ iddijalisi.
English: Date of first authorisation: 17/09/2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Settembru 2015
English: In a maintenance of efficacy study, upon switching from guanfacine to placebo, 7/158 (4.4%) subjects experienced increases in blood pressure to values above 5 mmHg and also above the 95
Maltese: Fi studju ta' manteniment tal-effikaċja, mal-qlib minn guanfacine għal plaċebo, 7/158 (4.4 %) individwu esperjenzaw żidiet fil-pressjoni tad-demm għall-valuri ta' aktar minn 5 mmHg u wkoll aktar mill-95 perċentili għall-età, sess u statura (ara sezzjonijiet 4.8 u 5
English: Respiratory, thoracic, and mediastinal disorders Asthma
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Ażżma
English: Dose adjustment is recommended with concomitant use of moderate/strong CYP3A4/5 inhibitors (e.g., ketoconazole, grapefruit juice), or strong CYP3A4 inducers (e.g., carbamazepine) (see section 4.5).
Maltese: Aġġustament fid-doża hu rakkomandat bl-użu fl-istess ħin ta' inibituri moderati/qawwija ta' CYP3A4/5 (eż. ketoconazole, meraq tal-grejpfrut), jew indutturi qawwija ta' CYP3A4
English: Adult patients Intuniv has not been studied in adults with ADHD.
Maltese: Intuniv ma ġiex studjat f'adulti bl-ADHD.
English: Intuniv with food, drinks and alcohol
Maltese: Intuniv ma' ikel, xorb u alkoħol
English: Guanfacine showed a significantly greater improvement in the ADHD-RS-IV total score compared with subjects receiving placebo.
Maltese: Guanfacine wera titjib akbar b'mod sinifikanti filpunteġġ totali ta' ADHD-RS-IV meta mqabbel ma' individwi li rċivew plaċebo.
English: In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval prolongation that exceeded change from baseline greater than >60 ms Fridericia-correction and Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among Intuniv patients.
Maltese: II-III li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, dwar monoterapija, iż-żidiet rispettivi fit-titwil tal-intervall tal-QTc li qabżu l-bidla mil-linja bażi b'aktar minn > 60 ms Fridericia-correction u Bazett-correction, kienu 0 (0.0%) u 2 (0.3%) fost il-pazjenti li kienu qed jieħdu plaċebo, u 1 (0.1%) u 1 (0.1%) fost pazjenti li kienu qed jieħdu Intuniv.
English: There was a substantial increase in the rate and extent of guanfacine exposure when administered with ketoconazole; the guanfacine peak plasma concentrations (Cmax) and exposure (AUC) increased 2- and 3-fold, respectively.
Maltese: Kien hemm żieda sostanzjali fir-rata u l-grad ta' esponiment ta' guanfacine meta jingħata ma' ketoconazole; il-konċentrazzjonijiet massimi fil-plażma (Cmax) ta' guanfacine u l-esponiment (AUC) żdiedu bid-doppju u bi 3 darbiet, rispettivament.
English: Intuniv 3 mg pack sizes: 28 or 84 tablets.
Maltese: Daqsijiet tal-pakketti ta' Intuniv 3 mg: 28 jew 84 pillola.
English: Co-administration of Intuniv with moderate and strong CYP3A4/5 inhibitors elevates plasma guanfacine concentrations and increases the risk of adverse reactions such as hypotension, bradycardia, and sedation.
Maltese: L-għoti ta' Intuniv ma' inibituri moderati u qawwija ta' CYP3A4/5 jgħolli l-konċentrazzjonijiet ta' guanfacine fil-plażma u jżid ir-riskju ta' reazzjonijiet avversi bħal pressjoni baxxa, bradikardija, u sedazzjoni.
English: Guanfacine is a selective alpha2A-adrenergic receptor agonist in that it has 15-20 times higher affinity for this receptor subtype than for the alpha2B or alpha2C subtypes.
Maltese: Guanfacine hu agonist selettiv tar-riċettur alpha2A-adrenerġiku, fis-sens li għandu affinità ogħla ta' 15-20 darba għal dan is-sottotip ta' riċettur milli għas-sottotipi alpha2B jew alpha2C.
English: 58.5 kg and above
Maltese: 58.5 kg u aktar Doża
English: • pale skin colour (pallor)
Maltese: • kulur pallidu tal-ġilda (sfurija)
English: Depending on the patient's response and tolerability for Intuniv the recommended maintenance dose range is 0.05-0.12 mg/kg/day.
Maltese: Skont ir-rispons u t-tollerabilità tal-pazjent għal Intuniv, il-medda rakkomandata tad-doża ta' manteniment hi ta' 0.05-0.12 mg/kg/jum.
English: Used to treat
Maltese: Tqala u treddigħ
English: Sinus arrhythmia
Maltese: Arritmija tas-sinus
English: EU/1/15/1040/003 7 prolonged-release tablets EU/1/15/1040/004 28 prolonged-release tablets EU/1/15/1040/005 84 prolonged-release tablets
Maltese: EU/1/15/1040/003 7 pilloli li jerħu l-mediċina bil-mod EU/1/15/1040/004 28 pillola li jerħu l-mediċina bil-mod EU/1/15/1040/005 84 pillola li jerħu l-mediċina bil-mod
English: Common: feeling drowsy (sedation), feeling dizzy (hypotension), slow heart beat (bradycardia).
Maltese: Komuni: tħossok bi ngħas (sedazzjoni), tħossok stordut (pressjoni baxxa) rata ta' taħbit tal-qalb bil-mod (bradikardija).
English: Used to control epilepsy.
Maltese: Jintużaw biex jikkontrollaw l-epilessija.
English: Very rare: a serious withdrawal side effect of high blood pressure after suddenly stopping Intuniv; symptoms may include headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).
Maltese: Rari ħafna: effett sekondarju serju ta' twaqqif ta' pressjoni tad-demm għolja wara li twaqqaf Intuniv f'daqqa; is-sintomi jistgħu jinkludu uġigħ ta' ras, tħossok konfuż/a, nervi, aġitazzjoni, u rogħda (enċefalopatija ipertensiva).
English: The elimination half-life of guanfacine is approximately 18 hours.
Maltese: Il-half-life tal-eliminazzjoni ta' guanfacine hi ta' madwar 18-il siegħa.
English: 7 prolonged-release tablets 28 prolonged-release tablets 84 prolonged-release tablets
Maltese: 7 pilloli li jerħu l-mediċina bil-mod 28 pillola li jerħu l-mediċina bil-mod 84 pillola li jerħu l-mediċina bil-mod
English: Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
Maltese: Intuniv irid jintuża bħala parti minn programm komprensiv ta' kura għall-ADHD, li tipikament jinkludi miżuri psikoloġiċi, edukattivi u soċjali.
English: In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval prolongation that exceeded change from baseline greater than 60 ms Fridericia-correction and Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among Intuniv patients.
Maltese: II-III li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, dwar monoterapija, iż-żidiet rispettivi fit-titwil tal-intervall tal-QTc li qabżu l-bidla mil-linja bażi b'aktar minn 60 ms Fridericia-correction u Bazett-correction, kienu 0 (0.0%) u 2 (0.3%) fost il-pazjenti li kienu qed jieħdu plaċebo, u 1 (0.1%) u 1 (0.1%) fost pazjenti li kienu qed jieħdu Intuniv.
English: The effects of guanfacine in the treatment of ADHD has been examined in 5 controlled studies in children and adolescents (6 to 17 years), 3 short-term controlled trials in children and adolescents aged 6 to 17 years, 1 short-term controlled study in adolescents aged 13 to 17 years, and 1 randomised withdrawal trial in children and adolescents aged 6-17 years, all of whom met the DSM-IV-TR criteria for ADHD.
Maltese: L-effetti ta' guanfacine fil-kura ta' ADHD ġew eżaminati f'5 studji kkontrollati fi tfal u adolexxenti (minn 6 sa 17-il sena), 3 provi kkontrollati li damu żmien qasir fi tfal u adolexxenti li kellhom minn 6 sa 17-il sena, 1 studju kkontrollat li dam żmien qasir fl-adolexxenti li kellhom minn 13 sa 17-il sena, u prova waħda li fiha l-parteċipanti ntgħażlu b'mod każwali, dwar it-twaqqif tal-mediċina fi tfal u adolexxenti li kellhom bejn 6-17-il sena, li kollha ssodisfaw il-kriterji DSM-IV-TR għall-ADHD.
English: Moderate CYP3A4/5 inhibitors
Maltese: Inibituri moderati ta' CYP3A4/5
English: Intuniv 4 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Maltese: Intuniv 4 mg pillola Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 4 mg ta' guanfacine.
English: Paediatric patients (children and adolescents 6-17 years old inclusive) who develop lethargy should be observed for the development of more serious toxicity including coma, bradycardia, and hypotension for up to 24 hours, due to the possibility of delayed onset of these symptoms.
Maltese: Pazjenti pedjatriċi (tfal u adolexxenti li jkollhom minn 6-17-il sena, inklużivi) li jiżviluppaw letarġija, għandhom jiġu osservati għall-iżvilupp ta' tossiċità aktar serja li tinkludi koma, bradikardija u pressjoni baxxa għal sa 24 siegħa, minħabba l-possibbiltà ta' dewmien fil-bidu ta' dawn is-sintomi.
English: When Intuniv is co-administered with valproic acid, patients should be monitored for potential additive central nervous system (CNS) effects and consideration should be given to the monitoring of serum valproic acid concentrations.
Maltese: Meta Intuniv jingħata flimkien ma' valproic acid, il-pazjenti għandhom jiġu mmonitorjati għal potenzjal ta' effetti addittivi fuq is-sistema nervuża ċentrali (CNS) u għandha tingħata konsiderazzjoni għall-monitoraġġ tal-konċentrazzjonijiet ta' valproic acid fis-serum.
English: Intuniv can cause syncope, hypotension and bradycardia.
Maltese: Intuniv jista' jikkawża sinkope, pressjoni baxxa u bradikardija.
English: • feeling sleepy (somnolence)
Maltese: • tħossok bi ngħas (sonnolenza)
English: • diarrhoea, abdominal discomfort or constipation
Maltese: • dijarea, skonfort addominali jew stitikezza
English: Uncommon: feeling faint or loss of conciousness (syncope).
Maltese: Mhux komuni: ħass ħażin jew telf mis-sensi (sinkope).
English: Study (SPD503-315) was a 41 week long term maintenance of efficacy study which included an open-label phase (up to 13 weeks) followed by double-blind, placebo-controlled, randomised-withdrawal phase (up to 26 weeks), conducted in paediatric patients (children and adolescents aged 6-17 years old inclusive) (n=526 in the open-label phase and n=315 in the double-blind randomised-withdrawal phase) to assess the efficacy, safety, and tolerability of once-daily dosing with guanfacine (children: 1-4 mg/day, adolescents:1-7 mg/day) in the treatment of ADHD.
Maltese: L-istudju (SPD503-315) kien studju fit-tul li dam 41 ġimgħa, dwar il-manteniment tal-effikaċja, li kien jinkludi fażi open-label (sa 13-il ġimgħa) segwita minn fażi double-blind, ikkontrollata bi plaċebo, li fiha l-parteċipanti ntgħażlu b'mod każwali, dwar it-twaqqif tal-mediċina (sa 26 ġimgħa), li twettaq fuq pazjenti pedjatriċi (tfal u adolexxenti li kellhom bejn 6-17-il sena, inklużivi) (n=526 fil-fażi open-label u n=315 fil-fażi double-blind, li fiha l-parteċipanti ntgħażlu b'mod każwali, dwar it-twaqqif talmediċina) biex jevalwa l-effikaċja, is-sigurtà, u t-tollerabilità ta' dożaġġ ta' darba kuljum bi guanfacine (tfal: 1-4 mg/jum, adolexxenti: 1-7 mg/jum) fil-kura tal-ADHD.
English: CNS depressant medicinal products
Maltese: GĦAMLA FARMAĊEWTIKA
English: • difficulty to get or keep an erection (erectile dysfunction).
Maltese: • diffikultà biex ikollok jew iżżomm erezzjoni (disfunzjoni erettili).
English: Effects on height, weight and body Mass index (BMI) Careful follow-up for weight suggests that children and adolescents who took Intuniv in the study (i.e., treatment for 7 days per week throughout the year) have demonstrated by an age- and sex-normalised mean change from baseline in BMI percentile, 4.3 over 1 year (average percentiles at baseline and 12 months were 68.3 and 73.1, respectively).
Maltese: Effetti fuq it-tul, il-piż u Indiċi tal-Massa tal-Ġisem (BMI) Follow-up bir-reqqa tal-piż jissuġġerixxi li t-tfal u l-adolexxenti li ħadu Intuniv fl-istudju (i.e. kura għal 7 ijiem kull ġimgħa matul is-sena) urew, skont bidla medja normalizzata għall-età u s-sess talpersuna mil-linja bażi fil-percentile tal-BMI, 4.3 fuq perjodu ta' sena (il-percentiles medji fil-linja bażi u 12-il xahar kienu ta' 68.3 u 73.1, rispettivament).
English: • Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine
Maltese: • Kull pillola ta' 2 mg fiha guanfacine hydrochloride ekwivalenti għal 2 mg ta' guanfacine.
English: • Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine
Maltese: • Kull pillola ta' 1 mg fiha guanfacine hydrochloride ekwivalenti għal 1 mg ta' guanfacine.
English: The primary efficacy assessment was the ADHD-RS-IV total score.
Maltese: L-evalwazzjoni tal-effikaċja primarja kien il-punteġġ totali ta' ADHD-RS-IV.
English: The impact of renal impairment on the pharmacokinetics of guanfacine in paediatric patients (children and adolescents 6-17 years old) was not assessed.
Maltese: L-impatt ta' indeboliment tal-kliewi fuq il-farmakokinetika ta' guanfacine f'pazjenti pedjatriċi (tfal u adolexxenti li jkollhom minn 6-17-il sena) ma ġiex evalwat.
English: EU/1/15/1040/008 28 prolonged-release tablets EU/1/15/1040/009 84 prolonged-release tablets
Maltese: EU/1/15/1040/008 28 pillola li jerħu l-mediċina bil-mod EU/1/15/1040/009 84 pillola li jerħu l-mediċina bil-mod
English: Similar results for the efficacy of guanfacine in the treatment of ADHD were established in 2 randomised, double-blind, placebo-controlled, fixed-dose (range of 1-4 mg/day) monotherapy trials in paediatric patients (children and adolescents 6-17 years old inclusive).
Maltese: Riżultati simili għall-effikaċja ta' guanfacine fil-kura tal-ADHD ġew stabbiliti f'2 provi li fihom ilparteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo, b'doża fissa (medda ta' 14 mg/jum), dwar monoterapija f'pazjenti pedjatriċi (tfal u adolexxenti li kellhom minn 6-17-il sena, inklużivi).
English: Intuniv 3 mg tablet 7.94mm round, green tablets debossed with ‘3MG' on one side and ‘503' on the other side.
Maltese: Pilloli tondi ta' 7.94 mm, ta' kulur aħdar, imnaqqxin bi ‘3MG' fuq naħa waħda u ‘503' fuq in-naħa loħra.
English: • The 4 mg prolonged-release tablets are oval and green, hard tablets, debossed with 4MG on one side and 503 on the other side.
Maltese: • Il-pilloli ta' 4 mg li jerħu mediċina bil-mod huma ovali u ħodor, pilloli ibsin, imnaqqxin b'4MG fuq naħa waħda u 503 fuq in-naħa l-oħra.
English: • The 3 mg prolonged-release tablets are round and green, hard tablets, debossed with 3MG on one side and 503 on the other side.
Maltese: • Il-pilloli ta' 3 mg li jerħu mediċina bil-mod huma tondi u ħodor, pilloli ibsin, imnaqqxin bi 3MG fuq naħa waħda u 503 fuq in-naħa l-oħra.
English: The increases in blood pressure were observed in some individuals at the end of the follow up period which ranged between 3 and 26 weeks post final dose (see sections 4.2 and 5.1).
Maltese: Fl-aħħar tal-perjodu ta' segwitu, ġew osservati żidiet filpressjoni tad-demm f'xi individwi li varjaw bejn 3 u 26 ġimgħa wara d-doża finali (ara sezzjonijiet 4.2 u 5.1).
English: • a serious withdrawal side effect of high blood pressure after suddenly stopping Intuniv; symptoms may include headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).
Maltese: • effett sekondarju serju ta' twaqqif ta' pressjoni tad-demm għolja wara li twaqqaf Intuniv f'daqqa; is-sintomi jistgħu jinkludu uġigħ ta' ras, tħossok konfuż/a, nervi, aġitazzjoni, u rogħda (enċefalopatija ipertensiva).
English: Renal excretion is the major elimination pathway (80%) with parent drug accounting for 30% of the urinary radioactivity.
Maltese: It-tneħħija mill-kliewi hu l-passaġġ maġġuri ta' eliminazzjoni (80%) bil-mediċina primarja li tammonta għal 30% tar-radjuattività fl-awrina.
English: Weight Group Week 1 Week 2 Week 3 Week 4 25 kg and up
Maltese: Grupp ta' Piż Ġimgħa 1 Ġimgħa 2 Ġimgħa 3 Ġimgħa 4 25 kg u aktar
English: Study SPD503-314 was conducted in children aged 6-12 years to assess the efficacy of once daily dosing with guanfacine (1-4 mg) administered either in the morning or the evening.
Maltese: Studju SPD503-314 twettaq fi tfal li kellhom minn 6-12-il sena biex jevalwa l-effikaċja ta' dożaġġ ta' darba kuljum bi guanfacine (1-4 mg) mogħti jew filgħodu jew filgħaxija.
English: • Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine
Maltese: • Kull pillola ta' 4 mg fiha guanfacine hydrochloride ekwivalenti għal 4 mg ta' guanfacine.
English: • Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine
Maltese: • Kull pillola ta' 3 mg fiha guanfacine hydrochloride ekwivalenti għal 3 mg ta' guanfacine.
English: Adolescents weighing 58.5 kg and above may be titrated to a 7 mg/day dose after the subject has completed a minimum of 1 week of therapy on a 6 mg/day dose and the physician has performed a thorough review of the subject's tolerability and efficacy.
Maltese: Adolexxenti li jiżnu 58.5 kg jew aktar, jistgħu jiġu ttitrati għal doża ta' 7 mg/jum wara li lindividwu jkun lesta minimu ta' ġimgħa waħda ta' terapija fuq doża ta' 6 mg/jum, u t-tabib ikun wettaq reviżjoni dettaljata tat-tollerabilità u l-effikaċja tal-individwu.
English: Intuniv 2 mg tablet Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Maltese: Intuniv 2 mg pillola Kull pillola fiha guanfacine hydrochloride ekwivalenti għal 2 mg ta' guanfacine.
English: Before Intuniv is used with any other centrally active depressants (such as alcohol, sedatives, phenothiazines, barbiturates, or benzodiazepines) the potential for additive sedative effects should be considered.
Maltese: Qabel Intuniv jintuża ma' kwalunkwe depressanti oħrajn attivi b'mod ċentrali (bħal alkoħol, sedattivi, barbiturates, phenothiazines, jew benzodiazepines), il-potenzjal għal effetti sedattivi addittivi għandu jiġi kkunsidrat.
English: Intuniv 2 mg prolonged-release tablets Guanfacine
Maltese: Intuniv 2 mg pilloli li jerħu l-mediċina bil-mod Guanfacine
English: Careful dose titration and monitoring is necessary at the start of treatment with Intuniv since clinical improvement and risks for several clinically significant adverse reactions (syncope, hypotension, bradycardia, somnolence and sedation) are dose- and exposure-related.
Maltese: Titrazzjoni tad-doża u monitoraġġ bir-reqqa huma meħtieġa fil-bidu tal-kura b'Intuniv, billi titjib kliniku u riskji għal diversi reazzjonijiet avversi klinikament sinifikanti (sinkope, pressjoni baxxa, bradikardija, ngħas u sedazzjoni) huma relatati mad-doża u mal-esponiment.
English: Furthermore, based on in vitro studies, guanfacine may be an inhibitor of OCT1 at maximal portal vein concentrations.
Maltese: Barra minn hekk, abbażi ta' studji in vitro, guanfacine jista' jkun inibitur ta' OCT1 f'konċentrazzjonijiet massimali fil-vina portali.