FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients with X-linked hypophosphataemia is low, the disease is considered ‘rare', and Crysvita was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 October 2014.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn ipofosfatażija marbuta ma' X huwa baxx, il-marda hija kkunsidrata “rari”, u Crysvita ġie kklassifikat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fil15 ta' Ottubru 2014.
English: The recommended dose at the start of treatment is 0.4 mg per kg of body weight, and then 0.8 mg/kg every two weeks to continue treatment.
Maltese: Id-doża rrakkomandata fil-bidu tal-kura hija ta' 0.4 mg għal kull kg tal-piż tal-ġisem, u mbagħad 0.8 mg/kg kull ġimagħtejn biex tkompli l-kura.
English: An additional ongoing study in 13 younger children shows that Crysvita is effective in those aged between 1 and 4 years.
Maltese: Studju kontinwu addizzjonali fi 13-il tifel u tifla iżgħar juri li Crysvita huwa effettiv f'dawk li għandhom bejn 1 u 4 snin.
English: Crysvita is a medicine used for the treatment of X-linked hypophosphataemia, a hereditary disorder characterised by low levels of phosphate in the blood (hypophosphataemia).
Maltese: Crysvita huwa mediċina użata għall-kura tal-ipofosfatemija marbuta ma' X, marda ereditarja kkaratterizzata minn livelli baxxi ta' fosfat fid-demm (ipofosfatemija).
English: Oral phosphate and vitamin D medicines must not be used during treatment with Crysvita.
Maltese: Il-fosfat orali u l-mediċini tal-vitamina D m'għandhomx jintużaw waqt il-kura bi Crysvita.
English: Why is Crysvita approved?
Maltese: Għaliex ġie approvat Crysvita?
English: What are the risks associated with Crysvita?
Maltese: X'inhuma r-riskji assoċjati ma' Crysvita?
English: What information is still awaited for Crysvita?
Maltese: Liema informazzjoni għadha mistennija għal Crysvita?
English: By attaching to the FGF23 protein, the medicine blocks its activity, allowing the kidneys to reabsorb phosphate and restore normal levels of phosphate in the blood.
Maltese: Billi tingħaqad mal-proteina FGF23, il-mediċina timblokka l-attività tagħha, li tippermetti lill-kliewi jerġgħu jeħilsu l-fosfat u jirrestawraw il-livelli normali ta' fosfat fid-demm.
English: Crysvita was shown to reduce the severity of bone deformities in the wrist and knee and improve the level of phosphate in the blood of children with X-linked hypophosphataemia in one ongoing study, and further data are awaited.
Maltese: Crysvita wera li jnaqqas is-severità tad-deformitajiet tal-għadam fil-polz u fl-irkoppa u li jtejjeb il-livell ta' fosfat fid-demm ta' tfal b'ipofosfatemija marbuta ma' X fi studju wieħed kontinwu, u hija mistennija aktar data.
English: Since Crysvita has been granted a conditional approval, the company that markets Crysvita will provide updated results from two ongoing studies in children aged between 5 and 12 years and between 1 and 4 years.
Maltese: Peress li Crysvita ngħatat approvazzjoni kondizzjonali, il-kumpanija li tikkummerċjalizza Crysvita sejra tipprovdi riżultati aġġornati minn żewġ studji kontinwi fi tfal ta' bejn 5 snin u 12-il sena u ta' bejn sena u 4 snin.
English: Patients with X-linked hypophosphataemia have abnormally high levels of a protein called FGF23 which causes the kidneys to stop reabsorbing phosphate into the bloodstream.
Maltese: Pazjenti b'ipofosfatemija marbuta ma' X għandhom livelli anormalment għoljin ta' proteina msejħa FGF23 li tikkawża li l-kliewi jieqfu milli jerġgħu jeħilsu l-fosfat fid-demm.
English: Crysvita reduced the severity of rickets as shown in X-rays in children with X-linked hypophosphataemia.
Maltese: Crysvita naqqas is-severità tar-rakitiżmu kif jidher fir-raġġi-X fi tfal b'ipofosfatemija marbuta ma' X.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in the management of patients with bone diseases caused by alterations in the body's chemical processes.
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn tabib b'esperjenza flimmaniġġjar ta' pazjenti b'mard tal-għadam ikkawżat minn alterazzjonijiet fil-proċessi kimiċi tal-ġisem.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru(i) jew tal-Istat(i) Membru(i) ta' Referenza jekk applikabbli, għandhom jiżguraw li l-kondizzjonijiet li ġejjin ikunu ssodisfati mill-MAH(s):
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Maltese: Anness IV Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjoni għattqegħid fis-suq
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Maltese: Il-MAHs għandhom jidentifikaw popolazzjoni speċifika ta' pazjenti li għaliha l-benefiċċji tal-prodott jegħlbu r-riskju.
English: Conditions for lifting the suspension of the marketing authorisation
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjoni għattqegħid fis-suq
English: Initiation pack: 28 tablets (7 x 90 mg + 21 x 180 mg)
Maltese: 28 pillola (7 x 90 mg +
English: 90 mg + 180 mg Film-coated tablet
Maltese: 90 mg + 180 mg
English: Invented name
Maltese: Apvalkotā tablete
English: Pharmaceutical Form Route of Administration
Maltese: 112-il pillola
English: Description:
Maltese: Deskrizzjoni:
English: Titanium dioxide (E171) Red iron oxide (E172)
Maltese: Diossidu tat-titanju (E171) Red iron oxide (E172)
English: • Pivotal study (07-AVR-123)
Maltese: • Studju pivitali (07-AVR-123)
English: BEGINNING DAY 8 Day 8
Maltese: TAL-BIDU 8 Jum 8
English: There are several hydroxylated metabolites of quinidine.
Maltese: Hemm diversi metaboliti idroksilati ta' quinidine.
English: DAYS 1-7 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
Maltese: JIEM 1-7 Jum 1 Jum 2 Jum 3 Jum 4 Jum 5
English: perphenazine, aripiprazole and chlorpromazine
Maltese: perphenazine, aripiprazole u chlorpromazine
English: In vitro transporter interaction studies
Maltese: Studji tal-interazzjoni mat-trasportaturi in vitro
English: Anticholinergic effects of quinidine
Maltese: Effetti antikolinerġiċi ta' quinidine
English: flecainide and beta-blockers (such as metoprolol)
Maltese: flecainide u imblokkaturi beta (bħal metoprolol)
English: Day 9
Maltese: Jum 9
English: Shellac glaze (20% esterified) Propylene glycol Titanium dioxide (E171)
Maltese: Inka tal-istampar Shellac glaze (20% esterifikat) Glikol tal-propilen Diossidu tat-titanju (E171)
English: • The other ingredients are croscarmellose sodium, cellulose microcrystalline, silica colloidal, lactose monohydrate, magnesium stearate and gelatin, titanium dioxide (E171), red iron oxide (E172), printing ink (shellac glaze, propylene glycol, titanium dioxide (E171)).
Maltese: • Is-sustanzi l-oħra huma croscarmellose sodium, cellulose microcrystalline, silica colloidal, lactose monohydrate, magnesium stearate u gelatin, titanium dioxide (E171), red iron oxide (E172), printing ink (shellac glaze, propylene glycol, titanium dioxide (E171)).
English: (syncope), fall
Maltese: (sinkope), waqgħa
English: • Weeks 2-4 (day 8-28):
Maltese: • Ġimgħat 2-4 (jum 8-28):
English: NMDA receptor antagonists (memantine)
Maltese: Antagonisti tar-riċetturi NMDA (memantine)
English: NUEDEXTA is a combination of two active substances:
Maltese: NUEDEXTA huwa kombinazzjoni ta' żewġ sustanzi attivi:
English: Dextromethorphan has been shown to be a mild/moderate inhibitor of the OCT1 transporter in vitro.
Maltese: Dextromethorphan intwera li huwa inibitur ħafif/moderat tat-trasportatur OCT1 in vitro.
English: • you have a tendency to have falls.
Maltese: • għandek tendenza li taqa'.
English: • excessive muscle stiffness (spasticity)
Maltese: • ebusija eċċessiva fil-muskoli (spastiċità)
English: Dextromethorphan hydrobromide is the pharmacologically active ingredient that acts on the central nervous system (CNS).
Maltese: Dextromethorphan hydrobromide huwa s-sustanza farmakoloġikament attiva li taġixxi fuq is-sistema nervuża ċentrali (CNS).
English: Drug abuse and dependence
Maltese: Abbuż u dipendenza mid-droga
English: • increased liver enzymes (GGT, AST, ALT)
Maltese: • żieda fl-enzimi tal-fwied (GGT, AST, ALT)
English: Pack size: 60 capsules
Maltese: Daqs tal-pakkett: 60 kapsula
English: • loss of appetite (anorexia)
Maltese: • telf tal-aptit (anoressija)
English: Digoxin and other P-glycoprotein substrates
Maltese: Digoxin u substrati oħra tal-glikoproteina P
English: 60 hard capsules
Maltese: 60 kapsula iebsa
English: • Drug-drug interactions including involvement of CYP2D6 substrates and inhibitors
Maltese: • Interazzjonijiet mediċina-mediċina inkluż involviment ta' substrati u inibituri CYP2D6
English: The pharmacokinetics of dextromethorphan/quinidine in paediatric patients has not been studied (see section 5.1).
Maltese: Il-farmakokinetika ta' dextromethorphan/quinidine f'pazjenti pedjatriċi ma ġietx studjata (ara sezzjoni 5.1).
English: Skeletal injury
Maltese: Korriment skeletriku
English: Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Maltese: Silika, anhydrous kollojdali Lactose monohydrate Magnesium stearate
English: Serotonin syndrome
Maltese: Sindromu tas-serotonin
English: • medicines containing quinidine, quinine, or mefloquine.
Maltese: • mediċini li fihom quinidine, quinine, jew mefloquine.
English: The tricyclic antidepressant desipramine is metabolized primarily by CYP2D6.
Maltese: L-antidepressant triċikliku desipramine huwa metabolizzat primarjament minn CYP2D6.
English: In vitro CYP P450 interaction studies
Maltese: Studji in vitro tal-interazzjoni ma' CYP P450
English: Paroxetine exposure (AUC0-24) increased by 1.7 fold and Cmax increased by 1.5 fold.
Maltese: L-esponiment għal paroxetine (AUC0-24) żdied b'1.7 darbiet u s-Cmax żdiedet b'1.5 darbiet.
English: The maximum mean (95% upper confidence bound) difference from placebo after baseline correction was 10.2 (12.6) ms.
Maltese: Id-differenza massima medja (95% limitu ta' fuq ta' kunfidenza) mill-plaċebo wara korrezzjoni fil-linja bażi kienet 10.2 (12.6) ms.
English: • medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
Maltese: • mediċini użati għall-kura ta' infezzjonijiet fungali, bħal ketoconazole, itraconazole, fluconazole
English: • Serotonin syndrome
Maltese: • Sindromu tas-serotonin
English: • rare (≥1/10,000 to <1/1,000)
Maltese: • rari (≥1/10,000 sa <1/1,000)
English: • From Week 4 on:
Maltese: Wara 4 ġimgħat:
English: Marketing Authorisation Holder and Manufacturer Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
English: The pharmacokinetics of dextromethorphan/quinidine have not been investigated systematically in elderly subjects (aged >65 years) although such subjects were included in the clinical programme (14% ≥65 years, 2% ≥75 years).
Maltese: Il-farmakokinetika ta' dextromethorphan/quinidine ma ġietx studjata b'mod sistematiku f'persuni anzjani (età ta' >65 sena) għalkemm tali individwi kienu inklużi fil-programm kliniku (14% ≥65 sena, 2% ≥75 sena).
English: These may be a sign of a serious condition called “serotonin syndrome”.
Maltese: Dawn jistgħu jkunu sinjali ta' kondizzjoni serja msejħa “sindromu tas-serotonin”.
English: A population pharmacokinetic analysis revealed similar pharmacokinetics in patients <65 years and those ≥65 years of age (see section 5.2).
Maltese: Analiżi farmakokinetika tal-popolazzjoni żvelat farmakokinetika simili fil-pazjenti ta' <65 sena u dawk ta' ≥65 sena (ara sezzjoni 5.2).
English: Quinidine did not inhibit (<30% inhibition) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4 in human microsomes at concentrations up to 5 µM.
Maltese: Quinidine ma inibiex (<30% inibizzjoni) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, jew CYP3A4 f'mikrosomi umani b'konċentrazzjonijiet sa 5 µM.
English: • Week 1 (day 1-7):
Maltese: • Ġimgħa 1 (jum 1-7):
English: • medicines used to treat various heart conditions, such as diltiazem, verapamil, digoxin,
Maltese: • mediċini użati għall-kura ta' diversi kundizzjonijiet tal-qalb, bħal diltiazem, verapamil, digoxin,
English: Desipramine (CYP2D6 substrate)
Maltese: Desipramine (substrat ta' CYP2D6)
English: • common (≥1/100 to <1/10)
Maltese: • komuni (≥1/100 sa <1/10)
English: • Summary of Product Characteristics (SmPC)
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott (SmPC)
English: They include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil.
Maltese: Dawn jinkludu, iżda mhumiex limitati għal, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, meraq tal-grejpfrut, u verapamil.
English: Dextromethorphan may increase the risk of serotonin syndrome (see Warnings and precautions and Possible side effects).
Maltese: Dextromethorphan jista' jżid ir-riskju tas-sindromu tas-serotonin (ara Twissijiet u prekawzjonijiet u Effetti sekondarji possibbli).
English: Combination with MAOIs is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni malMAOIs hija kontraindikata (ara sezzjoni 4.3).
English: The p-value for NUEDEXTA 23 mg /9 mg vs placebo was p=0.0002 and for NUEDEXTA 15 mg /9 mg vs placebo was p=0.008.
Maltese: Il-valur p għal NUEDEXTA 23 mg /9 mg vs placebo kien p=0.0002 u għal NUEDEXTA 15 mg /9 mg vs placebo kien p=0.008.
English: Diplopia, Vision blurred
Maltese: Vista doppja, Vista mċajpra
English: • Myocardial infarction, Palpitations, Ventricular extrasystoles
Maltese: Infart mijokardijaku, Palpitazzjonijiet, Extrasistoli
English: • weakness (asthenia), irritability
Maltese: • dgħufija (astenja), irritabilità
English: Thioridazine, a CYP2D6 substrates that also prolong the QT interval is contraindicated (see section 4.3).
Maltese: Thioridazine, substrat ta' CYP2D6 li wkoll itawwal l-intervall QT huwa kontraindikat (ara sezzjoni 4.3).
English: Approximately 1-10% of individuals of Caucasian descent, 5-30% of Black African descent, 12-40% of Arab descent and 1% of Asian descent exhibit increased metabolic activity for CYP2D6 substrates and are classified as Ultra-rapid Metabolizer (UMs).
Maltese: Madwar 1-10% tal-individwi ta' nisel Kawkasu, 5-30% tal-individwi ta' nisel Iswed Afrikan, 12-40% tal-individwi ta' nisel Għarbi u 1% tal-individwi ta' nisel Asjatiku juru attività metabolika akbar għassubstrati ta' CYP2D6 u huma kklassifikati bħala Metabolizzaturi Ultra-rapidi (UMs).
English: • certain medicines for depression, called monoamine oxidase inhibitors (MAOIs- for example phenelzine and moklobemide).
Maltese: • ċerti mediċini għad-depressjoni, imsejħa inibituri tal-monoamine oxidase (MAOIs- pereżempju phenelzine u moklobemide).
English: • Educational material for Healthcare Professionals (HCPs)
Maltese: • Materjal Edukattiv għall-Professjonisti tal-Kura tas-Saħħa (HCPs)
English: Quinidine is metabolized by CYP3A4.
Maltese: Quinidine jiġi metabolizzat minn CYP3A4.
English: A population pharmacokinetic analysis of 170 subjects (148 subjects <65 years old and 22 subjects ≥65 years old) administered dextromethorphan 23 mg / quinidine 26 mg revealed similar pharmacokinetics in subjects <65 years and those ≥65 years of age.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' 170 individwu (148 persuna kellhom <65 sena u 22 persuna kellhom ≥65 sena) li ngħataw dextromethorphan 23 mg / quinidine 26 mg żvelat farmakokinetika simili fil-persuni ta' <65 sena u dawk ta' ≥65 sena.
English: Dextromethorphan is rapidly metabolized by CYP2D6 to its primary metabolite, dextrorphan, which is rapidly glucuronidated and renally eliminated.
Maltese: Dextromethorphan jiġi metabolizzat malajr minn CYP2D6 fil-metabolit prinċipali tiegħu, dextrorphan, li jiġi glukuronidat rapidament u eliminat mill-kliewi.
English: Efficacy has only been studied in patients with underlying Amyotrophic Lateral Sclerosis or Multiple Sclerosis (see section 5.1).
Maltese: L-effikaċja ġiet studjata biss f'pazjenti bi Sklerożi Laterali Amijotrofika jew Sklerożi Multipla (ara sezzjoni 5.1).
English: The treatment of cardiac effects (haemodynamically unstable polymorphic ventricular tachycardia (including torsades de pointes)) is either immediate cardioversion or immediate overdrive pacing.
Maltese: Il-kura tal-effetti kardijaċi (takikardija ventrikolari poliformika emodinamikament instabbli) (inkluż ittorsades de pointes)) hija jew kardjoverżjoni immedjata jew overdrive pacing immedjat.
English: Pack size: 13 capsules
Maltese: Daqs tal-pakkett: 13-il kapsula
English: NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4).
Maltese: NUEDEXTA huwa indikat għall-kura sintomatika tal-effett psewdobulbari (PBA) f'persuni adulti (ara sezzjoni 4.4).
English: Cardiac effects
Maltese: Effetti kardijaċi
English: The mean plasma Cmax of quinidine following NUEDEXTA 15 mg / 9 mg twice daily in subjects with PBA was 1 to 3% of the therapeutic concentrations associated with antiarrhythmic efficacy (2 to 5 µg/mL).
Maltese: Is-Cmax medja fil-plażma ta' quinidine wara NUEDEXTA 15 mg / 9 mg darbtejn kuljum f'individwi b'PBA kienet 1 sa 3% tal-konċentrazzjonijiet terapewtiċi assoċjati mal-effikaċja antiarritmika (2 sa 5 µg/mL).
English: Plasma concentrations of quinidine increased 20-30% when memantine was added.
Maltese: Il-konċentrazzjonijiet ta' quinidine fil-plażma żdiedu b'20-30% meta żdied memantine.
English: Tricyclic antidepressants (TCAs e.g. desipramine, nortriptyline, imipramine, amitriptyline) are metabolised by CYP2D6 and therefore are also subject to pharmacokinetic interaction with quinidine.
Maltese: L-antidepressanti triċikliċi (TCAs eż. desipramine, nortriptyline, imipramine, amitriptyline) jiġu metabolizzati minn CYP2D6 u għalhekk huma soġġetti wkoll għal interazzjoni farmakokinetika ma' quinidine.
English: Dextromethorphan / quinidine has not been studied in patients with severe renal impairment.
Maltese: Dextromethorphan / quinidine ma ġiex studjat f'pazjenti b'indeboliment sever tal-kliewi.
English: Based on literature citations, drug-drug interactions as a result of quinidine inhibition of OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1, and MATE2-K are not expected.
Maltese: Fuq il-bażi ta' referenzi mil-letteratura, mhumiex mistennija interazzjonijiet bejn il-mediċini b'riżultat tal-inibizzjoni ta' OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1, u MATE2-K minn quinidine.
English: • medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbital
Maltese: • mediċini għall-kura tal-epilessija jew l-aċċessjonijiet, bħal phenytoin, carbamazepine u phenobarbital
English: Patients with a history of quinidine-, quinine-, mefloquine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome (see section 4.4).
Maltese: Pazjenti bi storja ta' tromboċitopenija kkawżata minn quinidine jew quinine jew mefloquine, epatite, depressjoni tal-mudullun jew sindromu jixbah il-lupus (ara sezzjoni 4.4).
English: Potent CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort/Hypericum perforatum) may accelerate the metabolism of quinidine, resulting in lower plasma concentrations and hence decreased inhibition of CYP2D6.
Maltese: (eż. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort/Hypericum perforatum) jistgħu jaċċelleraw il-metaboliżmu ta' quinidine, li jirriżulta f'konċentrazzjonijiet aktar baxxi fil-plażma u b'hekk inibizzjoni anqas ta' CYP2D6.
English: Other antiarrhythmics with Class I (procainamide) or Class III activities should (if possible) be avoided.
Maltese: Antiarritmiċi oħra b'attivitajiet ta' Klassi I (procainamide) jew ta' Klassi
English: The safety of NUEDEXTA was investigated in a double-blind, randomized, placebo-controlled, multicenter study over 12 weeks in 326 PBA patients with underlying ALS (60%) or MS (40%) and in a follow-up open-label extension phase with a patient subgroup of this study (253 patients) for an additional 84 days.
Maltese: Is-sigurtà ta' NUEDEXTA ġiet investigata fi studju multiċentri, double-blind, randomizzat u kkontrollat bil-plaċebo fuq 12-il ġimgħa fi 326 pazjent PBA b'ALS (60%) jew MS (40%) sottostanti u f'fażi ta' estensjoni ta' prova miftuħa ta' segwitu b'sottogrupp ta' pazjenti ta' dan l-istudju (253 pazjent) għal 84 jum addizzjonali.
English: Pharmacotherapeutic group: Other nervous system drugs; ATC code: N07XX59
Maltese: Mediċini oħra li jaħdmu fuq is-sistema nervuża; Kodiċi ATC:
English: The effects of supra-therapeutic doses of dextromethorphan /quinidine (23 mg /26 mg and 46 mg / 53 mg, for 7 consecutive doses) on QTc prolongation were evaluated in a randomised, placebocontrolled, double-blind, crossover design with an additional open-label positive control (400 mg moxifloxacin) arm in 36 healthy volunteers.
Maltese: L-effetti ta' dożi ogħla mid-doża terapewtika ta' dextromethorphan /quinidine (23 mg /26 mg u 46 mg / 53 mg, għal 7 dożi konsekuttivi) fuq it-titwil tal-QTc ġew evalwati f'disinn crossover randomizzat, double-blind u kkontrollat bil-plaċebo b'fergħa addizzjonali ta' prova miftuħa b'kontroll pożittiv (400 mg moxifloxacin) f'36 voluntier b'saħħithom.
English: • medicines used to treat HIV infection and AIDS, such as atazanavir, indinavir, nelfinavir,
Maltese: • mediċini użati għall-kura ta' infezzjoni tal-HIV u l-AIDS, bħal atazanavir, indinavir, nelfinavir,
English: Mean baseline CNS-LS scores were 19.8 in the NUEDEXTA 23 mg /9 mg group, 21.0 in the NUEDEXTA 15 mg /9 mg group, and 19.9 in the placebo group.
Maltese: Il-punteġġi medji fuq is-CNS-LS fil-linja bażi kienu 19.8 fil-grupp fuq NUEDEXTA 23 mg /9 mg, 21.0 fil-grupp fuq NUEDEXTA 15 mg /9 mg, u 19.9 fil-grupp li ħa l-plaċebo.
English: • uncommon (≥1/1,000 to <1/100)
Maltese: • mhux komuni (≥1/1,000 sa <1/100)
English: CYP2D6 substrates include certain beta-blockers such as metoprolol, antipsychotics such as haloperidol, perphenazine and aripiprazole, antidepressants such as nortriptyline, imipramine, amitriptyline and desipramine, the chemotherapeutic tamoxifen, and the noradrenaline transporter inhibitor atomoxetine.
Maltese: Is-substrati ta' CYP2D6 jinkludu ċerti imblokkaturi beta bħal metoprolol, antipsikotiċi bħal haloperidol, perphenazine u aripiprazole, antidepressanti bħal nortriptyline, imipramine, amitriptyline u desipramine, is-sustanza kimoterapewtika tamoxifen, u linibitur tat-trasportatur tan-noradrenaline, atomoxetine.
English: NUEDEXTA may cause dizziness (see section 4.8).
Maltese: NUEDEXTA jista' jikkawża sturdament (ara sezzjoni 4.8).
English: • heart attack (myocardial infarction), heart palpitations
Maltese: • attakk tal-qalb (infart mijokardijaku), palpitazzjonijiet tal-qalb
English: Mean baseline daily PBA episode rates (calculated from the total number of episodes reported for up to 7 pre-treatment days) were 4.7 in the NUEDEXTA 23 mg/9 mg group, 6.8 in the NUEDEXTA 15 mg/9 mg group, and 4.5 in the placebo group.
Maltese: Ir-rati medji ta' episodji ta' PBA kuljum fil-linja bażi (ikkalkulati min-numru totali ta' episodji rrappurtati sa 7 ijiem ta' prekura) kienu 4.7 fil-grupp fuq NUEDEXTA 23 mg/9 mg, 6.8 fil-grupp fuq NUEDEXTA 15 mg/9 mg, u 4.5 fil-grupp li ħa l-plaċebo.
English: • certain medicines used to treat depression, including nortriptyline, desipramine, paroxetine imipramine and amitriptyline, nefazodone
Maltese: • ċerti mediċini użati għall-kura tad-depressjoni, fosthom nortriptyline, desipramine, paroxetine imipramine u amitriptyline, nefazodone