FrancophonIA/ELRC3.0 huggingface dataset:
English: Qizenday was to be used to treat adults with the progressive form of multiple sclerosis, a disease in which the protective sheath around the nerve cells in the brain and spinal cord is damaged, and the nerves progressively degenerate.
Maltese: Qizenday kellu jintuża biex jikkura adulti bil-forma progressiva tal-isklerożi multipla, marda li fiha r-rita protettiva madwar iċ-ċelloli tan-nervituri fil-moħħ u fil-korda spinali titħassar, u n-nervituri jiddeġeneraw progressivament.
English: The second study involved 93 patients with multiple sclerosis who had visual loss due to inflammation of the optic nerve.
Maltese: It-tieni studju involva 93 pazjent bi sklerożi multipla li kellhom telf fil-vista minħabba infjammazzjoni tan-nerv ottiku.
English: The mechanism of action of Qizenday in multiple sclerosis is not well understood; however, it is thought that the medicine acts on enzymes (known as carboxylases) to increase energy production in the damaged nerves and to help repair the protective sheath around the nerve cells.
Maltese: Il-mekkaniżmu ta' azzjoni ta' Qizenday fl-isklerożi multipla għadu mhux mifhum sew; madankollu, huwa maħsub li l-mediċina taġixxi fuq l-enzimi (magħrufa bħala karbossilażi) biex iżżid il-produzzjoni tal-enerġija fin-nervituri bi ħsara u tgħin biex tissewwa r-rita protettiva madwar iċ-ċelloli tan-nervituri.
English: The company presented data from two main studies comparing Qizenday with placebo (a dummy treatment).
Maltese: Il-kumpanija ppreżentat data minn żewġ studji ewlenin li jqabblu Qidenzay mal-plaċebo (kura finta).
English: Symptoms include weakness, difficulty walking and problems with vision.
Maltese: Is-sintomi jinkludu dgħufija, diffikultà fil-mixi u problemi fil-vista.
English: What was Qizenday expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Qizenday?
English: The CHMP considered that the data on the medicine's effectiveness were not robust enough, and that there were uncertainties regarding the medicine's safety given the small number of patients treated with Qizenday.
Maltese: Is-CHMP qies li d-data dwar l-effikaċja tal-mediċina ma kinitx robusta biżżejjed, u li kien hemm inċertezzi dwar is-sigurtà tal-mediċina minħabba n-numru żgħir ta' pazjenti kkurati b'Qizenday.
English: Three of these enzymes are involved in energy production, while a fourth is believed to be involved in the production of sheaths around the nerve cells.
Maltese: Tlieta minn dawn l-enzimi huma involuti fil-produzzjoni tal-enerġija, filwaqt li huwa mifhum li oħra hija involuta fil-produzzjoni tar-rita madwar iċ-ċelloli tan-nervituri.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qizenday could not have been approved for the treatment of progressive multiple sclerosis.
Maltese: Fuq il-bażi tar-rieżami tad-data u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-fehma provviżorja li Qizenday ma setax jiġi approvat għall-kura tal-isklerożi multipla progressiva.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP's opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.
Maltese: Fl-ittra tagħha li fiha għarrfet lill-Aġenzija dwar l-irtirar tal-applikazzjoni, il-kumpanija ddikjarat li lirtirar kien ibbażat fuq l-opinjoni tas-CHMP li d-data klinika ppreżentata ma tippermettix lill-Kumitat jislet konklużjoni fuq bilanċ pożittiv bejn il-benefiċċju u r-riskju għal Qizenday.
English: St. John's Wort
Maltese: John's Wort
English: Fluconazole, itraconazole, posaconazole Fungal infections.
Maltese: Fluconazole, itraconazole, posaconazole Infezzjonijiet fungali.
English: • medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics)
Maltese: • mediċini għal problemi ta' saħħa mentali (benzodiazepines, barbiturates u antipsikotiċi)
English: Difference from placebo (95%CI)
Maltese: Differenza mill-plaċebo (95%CI)
English: Adolescent subjects must weigh at least 34 kg.
Maltese: Individwi adolexxenti iridu jkunu jiżnu mill-inqas 34 kg.
English: Adults and elderly
Maltese: Pazjenti adulti
English: Oral Methylphenidate
Maltese: Methylphenidate Orali
English: Intuniv contains the active substance guanfacine.
Maltese: Intuniv fih is-sustanza attiva guanfacine.
English: Summary of primary efficacy for study SPD503-316: ADHD-RS-IV
Maltese: Sommarju tal-effikaċja primarja għal studju SPD503-316: ADHD-RS-IV Gruppi ta' Kura
English: Crospovidone Type A Microcrystalline cellulose Silica, colloidal anhydrous Sodium laurilsulphate Polysorbate 80
Maltese: Microcrystalline cellulose Silica, colloidal anhydrous Sodium laurilsulphate Polysorbate 80
English: • indigestion (dyspepsia)
Maltese: • indiġestjoni (dispepsija)
English: Studies SPD503-301 and SPD503-304 were 8 and 9 weeks in duration, respectively, both conducted in the United States.
Maltese: Studji SPD503-301 u SPD503-304 damu 8 u 9 ġimgħat, rispettivament, u t-tnejn saru flIstati Uniti.
English: Guanfacine is not dialysable in clinically significant amounts (2.4%).
Maltese: Guanfacine mhuwiex dijalizzabbli f'ammonti klinikalment sinifikanti (2.4%).
English: The major urinary metabolites were 3-hydroxy guanfacine glucuronide, guanfacine dihydrodiol, 3-hydroxy guanfacine sulphate.
Maltese: Ilmetaboliti maġġuri fl-awrina kienu 3-hydroxy guanfacine glucuronide, guanfacine dihydrodiol, 3-hydroxy guanfacine sulphate.
English: Guanfacine is a non-stimulant.
Maltese: Guanfacine mhuwiex stimulant.
English: Difference from placebo (95%CI) Effect size
Maltese: Differenza minn plaċebo (95% CI)
English: • The other ingredients are hypromellose, methacrylic acid-ethyl acrylate copolymer, lactose monohydrate, povidone, crospovidone (Type A), microcrystalline cellulose, silica colloidal anhydrous, sodium laurilsulphate, polysorbate 80, fumaric acid, glyceryl dibehenate.
Maltese: • Is-sustanzi l-oħra huma hypromellose, methacrylic acid-ethyl acrylate copolymer, lactose monohydrate, povidone, crospovidone (Tip A), microcrystalline cellulose, silica colloidal anhydrous, sodium laurilsulphate, polysorbate 80, fumaric acid, glyceryl dibehenate.
English: • psychological therapy
Maltese: • terapija psikoloġika
English: Shire Pharmaceuticals Ireland Limited (as MA Logo)
Maltese: Shire Pharmaceuticals Ireland Limited (bħala Logo tal-MA)
English: Viral hepatitis.
Maltese: Epatite virali.
English: Atomoxetine
Maltese: Atomoxet ine
English: The peak plasma concentrations (Cmax) and exposure (AUC) of guanfacine decreased by 54% and 70% respectively.
Maltese: Ilkonċentrazzjonijiet massimi fil-plażma (Cmax) u l-esponiment (AUC) ta' guanfacine naqsu b'54% u 70% rispettivament.
English: 49.5-58.4 kg Max
Maltese: 49.5-58.4 kg Doża
English: • weight increase/risk of obesity
Maltese: • żieda fil-piż/riskju ta' obeżità
English: Hypotension, bradycardia and syncope
Maltese: Pressjoni baxxa, bradikardija u sinkope
English: 34-41.4 kg Max
Maltese: 34-41.4 kg Doża
English: Children (under 6 years old) and adults (18 years and over)
Maltese: Tfal (inqas minn 6 snin) u adulti (minn 18-il sena 'l fuq)
English: In human hepatic microsomes, guanfacine did not inhibit the activities of the other major cytochrome P450 isoenzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 or CYP3A5); guanfacine is also not expected to be an inducer of CYP3A, CYP1A2 and CYP2B6.
Maltese: Fil-mikrosomi tal-fwied tal-bniedem, guanfacine ma impedixxiex lattivitajiet tal-iżoenzimi maġġuri oħrajn ta' ċitokrom P450 (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 jew CYP3A5); guanfacine lanqas ma huwa mistenni li jkun induttur ta' CYP3A, CYP1A2 u CYP2B6.
English: The results showed that patients treated with add-on guanfacine improved more on the ADHD-RS-IV compared to those treated with add-on placebo (20.7 (12.6) points vs. 15.9 (11.8); difference: 4.9 95% CI 2.6 , 7.2).
Maltese: Ir-riżultati wrew li pazjenti kkurati b'add-on guanfacine, tjiebu aktar meta kienu fuq ADHD-RS-IV meta mqabbla ma' dawk ikkurati bi plaċebo add-on (20.7 (12.6) punti vs. 15.9 (11.8); differenza: 4.9 95% CI 2.6, 7.2).
English: HIV infection.
Maltese: Infezzjoni bl-HIV.
English: Guanfacine showed embryo foetal developmental toxicity in mice and rats (NOAEL 0.5 mg/kg/day) and in rabbits (NOAEL 3.0 mg/kg/day) in the presence of maternal toxicity.
Maltese: Guanfacine wera tossiċità fl-iżvilupp embrijofetali fil-ġrieden u l-firien (NOAEL 0.5 mg/kg/jum) u filfniek (NOAEL 3.0 mg/kg/jum) fil-preżenza ta' tossiċità materna.
English: Based on in vitro studies, guanfacine is a substrate of OCT1 and OCT2, but not BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1 or MATE2.
Maltese: Abbażi ta' studji in vitro, guanfacine huwa sottostrat ta' OCT1 u OCT2, iżda mhux BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1 jew MATE2.
English: • medicines for epilepsy such as valproic acid
Maltese: • mediċini għall-epilessija, bħal valproic acid
English: N Baseline ADHD-RS-IV (SD)
Maltese: N ADHDRS-IV (SD) fillinja bażi
English: Serious adverse reactions commonly reported include hypotension (3.2%), weight increase (2.9%), bradycardia (1.5%) and syncope (uncommon) (0.7%).
Maltese: Reazzjonijiet avversi serji rrappurtati b'mod komuni jinkludu pressjoni baxxa (3.2%), żieda fil-piż (2.9%), bradikardija (1.5%) u sinkope (mhux komuni) (0.7%).
English: These reductions represent a percentage reduction of 56% vs. 33% for guanfacine vs. placebo, respectively.
Maltese: 33% għal guanfacine vs. plaċebo, rispettivament.
English: Reproductive system and breast disorders Erectile dysfunction
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Disfunzjoni erettili
English: Guanfacine is not an inhibitor of BSEP, MRP2, OATP1B1, OATP1B3, OAT1, OAT3, OCT2 or MATE2K, but it is an inhibitor of MATE1 and may be an inhibitor of OCT1 at maximal portal vein concentrations.
Maltese: Guanfacine mhuwiex inibitur ta' BSEP, MRP2, OATP1B1, OATP1B3, OAT1, OAT3, OCT2 jew MATE2K, iżda huwa inibitur ta' MATE1 u jista' jkun inibitur ta' OCT1 f'konċentrazzjonijiet massimali fil-vina portali.
English: Guanfacine is moderately bound to plasma proteins (approximately 70%), independent of drug concentration.
Maltese: Guanfacine jeħel b'mod moderat mal-proteini fil-plażma (bejn wieħed u ieħor 70%), indipendentement mill-konċentrazzjoni tad-mediċina.
English: Bacterial infections.
Maltese: Infezzjonijiet batterjali.
English: The percentages of subjects who met response criteria (≥30% reduction from baseline in ADHD-RS-IV Total Score and a CGI-I value of 1 or 2) was 64.3% for guanfacine, 55.4% for atomoxetine and 42.3% for placebo.
Maltese: Ilperċentwali ta' individwi li laħqu l-kriterji ta' rispons (tnaqqis ta' ≥30% mil-linja bażi fil-Punteġġ Totali ta' ADHD-RS-IV u valur CGI-I ta' 1 jew 2) kienu ta' 64.3% għal guanfacine, 55.4% għal atomoxetine u 42.3% għall-plaċebo.
English: In addition 3 mg and 4 mg tablets include Indigo carmine aluminium lake E 132 Iron oxide yellow E 172
Maltese: • Il-pilloli ta' 3 mg u 4 mg fihom ukoll indigo carmine E132 u yellow iron oxide E 172
English: 41.5-49.4 kg Max
Maltese: 41.5-49.4 kg Doża
English: Somnolence/sedation, hypotension, bradycardia and syncope In the overall pool of guanfacine-treated patients, somnolence occurred in 40.6% and sedation in 10.2% of guanfacine-treated patients.
Maltese: Ngħas/sedazzjoni, pressjoni baxxa, bradikardija u sinkope Fil-ġabra globali ta' pazjenti kkurati bi guanfacine, ngħas seħħew f'40.6% u sedazzjoni f'10.2% talpazjenti kkurati bi guanfacine.
English: Treatment failure was defined as a ≥50% increase in ADHD-RS-IV total score and a ≥2 point increase in CGI-S score compared to the respective scores at the double-blind baseline visit.
Maltese: Il-falliment talkura kien definit bħala żieda ta' ≥50% fil-punteġġ totali ta' ADHD-RS-IV u żieda ta' ≥2 punti filpunteġġ CGI-S meta mqabbel mal-punteġġi rispettivi fil-viżta double-blind fil-linja bażi.
English: Intuniv can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4/5 (see sections 4.2, 4.4 and 5.2).
Maltese: Intuniv jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali mogħtija flimkien li jiġu metabolizzati permezz ta' CYP3A4/5 (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: ADHD with Oppositional Symptoms Study
Maltese: ADHD bi Studju ta' Sintomi Oppożizzjonali
English: Posaconazole
Maltese: Posaconazol
English: Cardiac disorders Bradycardia
Maltese: Disturbi fil-qalb Bradikardija
English: • educational therapy
Maltese: • terapija edukattiva
English: Pharmacotherapeutic group: Antihypertensives, antiadrenergic agents, centrally acting ATC code: C02AC02.
Maltese: Kodiċi ATC: C02AC02.
English: Co-administration with Psychostimulants
Maltese: L-għoti flimkien ma' Psikostimulanti
English: Thorough QT /QTc study
Maltese: Studju bir-reqqa tal-QT/QTc
English: The pharmacokinetics of guanfacine is similar in children (aged 6 to 12) and adolescents (aged 13 to 17) ADHD patients, and healthy adult volunteers.
Maltese: Il-farmakokinetika ta' guanfacine hi simili f'pazjenti tfal bl-ADHD (li jkollhom minn 6 sa 12) u f'pazjenti adolexxenti bl-ADHD (li jkollhom minn 13 sa 17-il sena), u voluntiera adulti b'saħħithom.
English: Preclinical research suggests guanfacine modulates signalling in the prefrontal cortex and basal ganglia through direct modification of synaptic noradrenalin transmission at the alpha 2- adrenergic receptors.
Maltese: Riċerka preklinika tissuġġerixxi li guanfacine jimmodula s-senjalazzjoni fil-kortiċi prefrontali u l-gangliji bażali permezz ta' modifikazzjoni diretta tat-trasmissjoni sinattika ta' noradrenalin fir-riċetturi alpha 2-adrenerġiċi.
English: The majority of patients achieved an optimised dose between 0.05-0.12mg/kg/day.
Maltese: Ilmaġġoranza tal-pazjenti kisbu doża ottimizzata bejn 0.05-0.12 mg/kg/jum.
English: Intuniv contains lactose:
Maltese: Intuniv fih il-lactose:
English: Signs and symptoms of overdose may include hypotension, initial hypertension, bradycardia, lethargy, and respiratory depression.
Maltese: Sinjali u sintomi ta' doża eċċessiva jistgħu jinkludu pressjoni baxxa, pressjoni għolja inizjali, bradikardija, letarġija, u tnaqqis respiratorju.
English: Weight Group a
Maltese: Grupp ta' Piż a
English: Intuniv 2 mg tablet EU/1/15/1040/003-005
Maltese: Intuniv 2 mg pillola EU/1/15/1040/003-005
English: Guanfacine was superior to placebo in the long-term maintenance of treatment in children and adolescents with ADHD as measured by cumulative treatment failures (49.3% for Intuniv, and 64.9% for placebo, p=0.006).
Maltese: Guanfacine kien superjuri għall-plaċebo fil-manteniment fit-tul tal-kura fi tfal u adolexxenti bl-ADHD, kif imkejjel millfallimenti kumulattivi tal-kura (49.3% għal Intuniv, u 64.9% għal plaċebo, p=0.006).
English: Oppositional symptoms were evaluated as the change from baseline to endpoint in the Oppositional Subscale of the Conners' Parent Rating Scale - revised Long Form (CPRS-R:L) score.
Maltese: Sintomi oppożizzjonali ġew evalwati bħala l-bidla mil-linja bażi sal-punt aħħari fis-Sottoskala Oppożizzjonali tal-punteġġ Conners' Parent Rating Scale - revised Long Form (CPRS-R:L).
English: Intuniv 4 mg tablet EU/1/15/1040/008-009
Maltese: Intuniv 4 mg pillola EU/1/15/1040/008-009
English: Cancer.
Maltese: Kanċer.
English: Each 3 mg tablet contains 37.81 mg of lactose (as monohydrate).
Maltese: Kull pillola ta' 3 mg fiha 37.81 mg ta' lactose (bħala monohydrate).
English: Results show statistically significantly (p≤0.05) greater mean reductions at endpoint from Baseline (indicating improvement) in oppositional subscale of CPRS-R:L scores in the guanfacine group compared to placebo (10.9 points vs. 6.8 for guanfacine vs. placebo, respectively) and the effect size was 0.6 (p<0.001).
Maltese: Ir-riżultati juru tnaqqis medju akbar b'mod statistikament sinifikanti (p≤0.05) fil-punt aħħari mil-Linja Bażi (li jindika titjib) fis-sottoskala oppożizzjonali tal-punteġġi CPRS-R:L fil-grupp ta' guanfacine meta mqabbel malplaċebo (10.9 punti vs 6.8 għal guanfacine vs. plaċebo, rispettivament) u d-daqs tal-effett kien ta' 0.6 (p<0.001).
English: General toxicity observed in animals (rat, dog) upon treatment with guanfacine included prolongation of uncorrected QT interval (heart), atrophic spleen and decreased white blood cells, affected liverincreased bilirubin and ALT levels included, irritated and inflamed intestines, increased creatinine and blood urea nitrogen levels (kidney), corneal clouding (eye) in rat and mouse only, alveolar macrophage infiltration & pneumonitis and reduced spermatogenesis.
Maltese: Tossiċità ġenerali osservata fl-annimali (firien, klieb) mal-kura bi guanfacine kienet tinkludi titwil talintervall tal-QT (qalb) mhux ikkorreġut, milsa atrofika u tnaqqis fiċ-ċelluli tad-demm bojod, fwied affettwat - żieda fil-livelli tal-bilirubina u fl-ALT inklużi, imsaren irritati u infjammati, żieda fil-livelli tal-kreatinina u tal-urea nitrogen fid-demm (kliewi), tidnis tal-kornea (għajn) fil-firien u fil-ġrieden biss, infiltrazzjoni tal-makrofaġi alveolari u pnewmonite u tnaqqis fl-ispermatoġenesi.
English: Dose Titration Schedule for Adolescents (Aged 13-17 Years)
Maltese: Skeda ta' Titrazzjoni tad-Doża għall-Adolexxenti (Li Jkollhom minn 13-17-il sena)
English: Bradycardia occurred in 1.5%, hypotension in 3.2% and syncope occurred in 0.7% of all guanfacine-treated patients.
Maltese: Bradikardija seħħet f'1.5%, pressjoni baxxa fi 3.2% u sinkope seħħ f'0.7% tal-pazjenti kollha kkurati bi guanfacine.
English: Intuniv 3 mg tablet EU/1/15/1040/006-007
Maltese: Intuniv 3 mg pillola EU/1/15/1040/006-007
English: Dose= 6 mg
Maltese: Massima=6 mg
English: In a drug interaction study, administration of Intuniv in combination with lisdexamfetamine dimesylate induced a 19% increase in guanfacine maximum plasma concentrations, whereas exposure (AUC) was increased by 7%.
Maltese: Fi studju dwar l-interazzjoni tal-mediċina, l-għoti ta' Intuniv flimkien ma' lisdexamfetamine dimesylate, ikkawża żieda ta' 19% fil-konċentrazzjonijiet massimi ta' guanfacine fil-plażma, filwaqt li l-esponiment (AUC) żdied b'7%.
English: Dose= 5 mg
Maltese: Massima=5 mg
English: Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate).
Maltese: Kull pillola ta' 4 mg fiha 50.42 mg ta' lactose (bħala monohydrate).
English: • Chart for ongoing monitoring (vital signs, height, weight) of patients during treatment with Intuniv.
Maltese: • Ċart għal monitoraġġ kontinwu (sinjali vitali, tul, piż) tal-pazjenti matul il-kura b'Intuniv.
English: Adverse Drug Reactions Reported with Intuniv System/Organ Class
Maltese: Reazzjonijiet Avversi tal-Mediċina Rrappurtati b'Intuniv Sistema tal-Klassifika tal-Organi
English: Available pharmacodynamic and toxicological data in animals have shown excretion of guanfacine and its metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika u tossikoloġika fl-annimali wriet li kien hemm eliminazzjoni ta' guanfacine/metaboliti fil-ħalib tas-sider (gћad-dettalji ara sezzjoni 5.3).
English: Guanfacine is an in vitro inhibitor of MATE1 and the clinical relevance of MATE1 inhibition cannot be excluded.
Maltese: Guanfacine huwa inibitur in vitro ta' MATE1 u r-relevanza klinika tal-inibizzjoni ta' MATE1 ma tistax tiġi eskluża.
English: Guanfacine is a substrate of CYP3A4 and CYP3A5, and exposure is affected by CYP3A4 and CYP3A5 inducers and inhibitors.
Maltese: Guanfacine hu substrat ta' CYP3A4 u CYP3A5, u l-esponiment jiġi affettwat minn indutturi u inibituri ta' CYP3A4 u CYP3A5.
English: The tablets come in pack sizes of 7, 28 or 84 but not all pack sizes may be available.
Maltese: Il-pilloli jiġu f'daqsijiet ta' pakketti ta' 7, 28 jew 84, iżda mhux id-daqsijiet kollha tal-pakkett jistgħu jkunu disponibbli.
English: Intuniv 1 mg prolonged-release tablets Intuniv 2 mg prolonged-release tablets Intuniv 3 mg prolonged-release tablets Intuniv 4 mg prolonged-release tablets
Maltese: Intuniv 1 mg pilloli li jerħu l-mediċina bil-mod Intuniv 2 mg pilloli li jerħu l-mediċina bil-mod Intuniv 3 mg pilloli li jerħu l-mediċina bil-mod Intuniv 4 mg pilloli li jerħu l-mediċina bil-mod
English: Intuniv 2 mg pack sizes: 7, 28 or 84 tablets.
Maltese: Daqsijiet tal-pakketti ta' Intuniv 2 mg: 7, 28 jew 84 pillola.
English: See section 4.2 for further dosing recommendations
Maltese: Ara sezzjoni 4.2 għal rakkomandazzjonijiet addizzjonali dwar id-dożaġġ
English: Active renal secretion is mediated via OCT2 transporter.
Maltese: It-tnixxija attiva mill-kliewi hi medjata permezz tat-trasportatur OCT2.
English: There is no evidence of any impact of ethnicity on the pharmacokinetics of Intuniv.
Maltese: M'hemm l-ebda evidenza ta' kwalunkwe impatt tal-etniċità fuq il-farmakokinetika ta' Intuniv.
English: Intuniv 1 mg pack sizes: 7 or 28 tablets.
Maltese: Daqsijiet tal-pakketti ta' Intuniv 1 mg: 7 jew 28 pillola.
English: • It can be taken with or without food, but do not take it with fatty foods (e.g., high fat breakfast).
Maltese: • Ibla' l-pillola sħiħa ma' belgħa ilma jew xi likwidu ieħor (iżda mhux meraq tal-grejpfrut).
English: How to store Intuniv
Maltese: X'inhu Intuniv
English: Dose= 7 mg
Maltese: Massima=7 mg
English: In the data set from controlled, doubled blinded and open-label clinical studies with Intuniv the most frequently reported adverse reactions (very common) include somnolence (40.6%), headache (27.4%), fatigue (18.1%), abdominal pain upper (12.0%), and sedation (10.2%).
Maltese: Fis-sett ta' dejta minn studji kliniċi kkontrollati, doubled blinded u open-label b'Intuniv l-iktar reazzjonijiet avversi rrappurtati b'mod frekwenti (komuni ħafna) jinkludu ngħas (40.6%), uġigħ ta' ras (27.4%), għeja (18.1%), uġigħ addominali fin-naħa ta' fuq (12.0%), u sedazzjoni (10.2%).
English: Syncope may involve risks of falls or accidents, which could result in serious harm (see sections 4.8 and 4.7).
Maltese: Sinkope jista' jinvolvu riskji ta' waqgħat jew inċidenti, li jistgħu jirriżultaw f'korriment serju (ara sezzjonijiet 4.8 u 4.7).
English: Intuniv 1 mg tablet
Maltese: Intuniv 1 mg pillola
English: It was designed to evaluate the efficacy and safety of guanfacine (1, 2, 3, and 4 mg/day) when co-administered with long-acting psychostimulants (amphetamine, lisdexamphetamine, methylphenidate, dexmethylphenidate) in children and adolescents aged 6-17 years with a diagnosis of ADHD and a suboptimal, partial response to psychostimulants.
Maltese: Kien maħsub biex jevalwa l-effikaċja u s-sigurtà ta' guanfacine (1, 2, 3, u 4 mg/jum) meta jingħata flimkien ma' psikostimulanti li jaħdmu fit-tul (amphetamine, lisdexamphetamine, methylphenidate, dexmethylphenidate) fi tfal u adolexxenti li kellhom bejn 6-17-il sena, b'dijanjosi ta' ADHD u rispons parzjali subottimali għal psikostimulanti.
English: Dose= 4 mg
Maltese: Massima=4 mg
English: CYP3A4 and CYP3A5 inhibitors
Maltese: Inibituri ta' CYP3A4 u CYP3A5
English: Change from baseline (SD)
Maltese: Tibdil mil-linja bażi (SD)
English: Guanfacine-treated patients were in statistically significantly better conditions on the functional outcome as measured by the clinical global impression of severity (CGI-S) at endpoint compared to placebo-treated patients.
Maltese: Pazjenti kkurati bi guanfacine kienu f'kundizzjonijiet aħjar b'mod statistikament sinifikanti fuq ir-riżultat funzjonali kif imkejjel mill-impressjoni globali klinika tas-severità (clinical global impression of severity, CGI-S) fil-punt aħħari meta mqabbla ma' pazjenti kkurati bi plaċebo.
English: Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.
Maltese: Intuniv hu indikat għal kura ta' attention deficit hyperactivity disorder (ADHD) fi tfal u adolexxenti li jkollhom minn 6-17-il sena li għalihom l-istimulanti mhumiex adattati, huma intollerabbli jew li wrew li mhumiex effikaċi.
English: Other medicines and Intuniv
Maltese: Mediċini oħra u Intuniv
English: Intuniv 2 mg tablet
Maltese: Intuniv 2 mg pillola
English: Syncope/loss of consciousness
Maltese: Sinkope/tintilef minn sensik