FrancophonIA/ELRC3.0 huggingface dataset:
English: Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Maltese: Terapija aġġuntiva fit-trattament ta' aċċessjonijiet ġeneraliżżati primarji tat-tip tonic-clonic f'adulti u adolexxenti minn 12-il sena b'epilessija ġeneralizzata idjopatika.
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1,800 mg/kg/day (x 6-17 the MRHD on a mg/m2 basis)
Maltese: Studji fl-annimali tat-twelid u ġovanili fil-firien u l-klieb urew li ma kienx hemm effetti avversi fil-punti tat-tmiem standard tal-iżvilupp jew maturazzjoni b'dożi sa 1800 mg/kg/ġurnata (x 6-17-il MRHD fuq bażi ta' mg/m
English: This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis.
Maltese: Dan il-post fejn jeħel huwa l-proteina tal-bużżieqa tas-sinapsi 2A, li hu magħruf li hu involut fil-fużjoni tal-bu żżieqa u exositożi ta' neurotransmitter.
English: How to store Levetiracetam Hospira
Maltese: Tiħux Levetiracetam Hospira
English: The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Maltese: Il-metodu prinċipali li bih jitneħħa huwa fl-awrina li tgħodd medja ta' 95 % tad-doża (madwar 93 % tad-doża kienet eliminata fi żmien 48 siegħa).
English: Add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg The initial therapeutic dose is 10 mg/kg twice daily.
Maltese: Doża fi tfal (4 sa 11-il sena) u adolexxenti (12 sa 17-il sena) li jiżnu inqas minn 50 kg:
English: Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Maltese: ma kienux mibdulin. Levetiracetam 2,000 mg kuljum ma kellux effett fuq il-farmakokinetika ta' digoxin u warfarin; ma kienux mibdulin il-prothrombin times.
English: 500 to 1,000 mg twice daily
Maltese: 500 sa 1,000 mg darbtejn kuljum
English: A large amount of post-marketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Maltese: Ammont kbir ta' dejta minn wara t-tqegħid fis-suq dwar nisa tqal esposti għal monoterapija b'levetiracetam ('il fuq minn 1800, li fosthom f'iktar minn 1500, l-esponiment seħħ matul l-ewwel trimestru tat-tqala) ma jissuġġerix żieda fir-riskju ta' malformazzjonijiet konġenitali maġġuri.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew derivati oħrajn ta' pyrrolidone, jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Levetiracetam Hospira 100 mg/ml concentrate for solution for infusion levetiracetam
Maltese: Levetiracetam Hospira 100 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function:
Maltese: Regolar tad-doża f'pazjenti adulti u adolexxenti li jiżnu iżjed minn 50 kg b'indeboliment fil-kliewi:
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Maltese: • sinjali ta' tibdil mentali serju, jew jekk xi ħadd madwarek jinnota sinjali ta' konfużjoni, sonnolenza (ngħas), amnesija (telf tal-memorja), indeboliment tal-memorja (tinsa), imġiba mhux normali jew sinjali newroloġiċi oħrajn li jinkludu movimenti involontarji jew mhux ikkontrollati.
English: Epilepsy is a condition where the patients have repeated fits (seizures).
Maltese: L-epilessija hija kundizzjoni fejn ilpazjent ikollu aċċessjonijiet ripetuti.
English: However, based on the pharmacokinetic characteristics of levetiracetam, the pharmacokinetics in adults after intravenous administration and the pharmacokinetics in children after oral administration, the exposure (AUC) of levetiracetam is expected to be similar in paediatric patients aged 4 to 12 years after intravenous and oral administration.
Maltese: Madanakollu, abbażi tal-karatteristiċi farmakokinetiċi ta' levetiracertam, il-farnakokinetiċi f'adulti wara l-għoti ġol-vina l-farmakokinetiċi fi tfal wara għoti orali, l-esponiment (AUC) ta' levetiracetam hu mistenni li jkun simili f'pazjenti pedjatriċi bejn l-etajiet ta' 4 sa 12-il sena wara għoti ġol-vina u orali.
English: Dose and frequency Children from 4 years and adolescents weighing less than 50 kg
Maltese: Tfal minn 4 snin u adolexxenti li jiżnu inqas minn 50 kg
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jista' jaffettwa sa 1 f'1,000 persuna)
English: Breast-feeding is not recommended during treatment.
Maltese: Mhux irrikkmandat ttreddigħ waqt it-trattament.
English: Cough
Maltese: Zaventem
English: Levetiracetam Hospira is used: on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Maltese: • waħdu f'pazjenti adulti u adolexxenti minn 16-il sena b'epilessija li għadha kif ġiet iddijanjostikata, fit-trattament ta' ċertu forma ta' epilessija.
English: 250 to 500 mg twice daily
Maltese: 250 sa 500 mg darbtejn kuljum
English: The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo.
Maltese: Ma kien hemmx tibdil filfarmakokinetika ta' levetiracetam meta ittieħed flimkien ma' digoxin, kontraċettivi orali u warfarin.
English: 1200 mg/kg/day for foetuses.
Maltese: 1,000 mg/ ġurnata
English: Then CLcr is adjusted for body surface area (BSA) as follows:
Maltese: Imbagħad, CLcr huwa aġġustat għall-erja tas-superfiċje tal-ġisem (BSA) bħal hawn taħt:
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Maltese: Wara d-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 5 u 10 mg/kg (0.05 sa 0.10 ml/kg).
English: In this study, levetiracetam dose was 3,000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Maltese: F'dan l-istudju, id-doża ta' levetiracetam kienet ta' 3,000 mg/jum fl-adulti u l-adolexxenti jew 60 mg/kg/jum fi tfal, li ingħataw f'2 dożi separati.
English: Convulsion, balance disorder, dizziness, lethargy, tremor
Maltese: Aċċessjoni, disturb fl-ekwilibriju, sturdament, letarġija, rogħda
English: The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1,500 mg intravenous infusion for 4 days with twice daily dosing.
Maltese: Il-profil farmakokinetiku ta' levetiracetem dwar l-indipendenza mill-ħin ġie kkonfermat wara għoti ta' 1,500 mg infużjoni ġol-vina għal 4 ijiem b'doża darbtejn kuljum.
English: If you stop using Levetiracetam Hospira:
Maltese: Levetiracetam Hospira huwa użat:
English: Levetiracetam Hospira concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Maltese: Id-doża rrikkmandata għandhatiġi dilwita f'tal-anqas 100 ml ta' diluwent kompatibbli u infuż fuq perijodu ta' 15-il minuta.
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Maltese: In-NOAEL kien ta' ≥ 1800 mg/kg/ġurnata għal firien feminili F0, u għas-sopravivenza, kobor u l-iżvilupp taż-żrameġ F1 sa kemm jibdew jieklu weħedhom ( x 6 ilMRHD fuq bażi ta'mg/m
English: Directions for the proper use of Levetiracetam Hospira is provided in section 3.
Maltese: Istruzzjonijiet dwar l-użu kif suppost ta' Levetiracetam Hospira hu mogħti f'sezzjoni 3.
English: 500 mg 5 ml (one 5 ml vial)
Maltese: 500 mg 5 ml (kunjett wieħed ta' 5 ml)
English: For doctors and nurses, more detailed direction for the proper use of Levetiracetam Hospira is provided in section 6.
Maltese: Għal tobba u infermiera, ara istruzzjonijiet dettaljati dwar l-użu korrett ta' Levetiracetam Hospira f'sezzjoni 6.
English: Add-on therapy for infants and children less than 4 years The safety and efficacy of levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
Maltese: Terapija miżjuda fi trabi u tfal ta'inqas minn età ta' 4 snin Is-sigurtà u l-effikaċja ta' levetiracetam konċentrat għal soluzzjoni għall-infużjoni fi trabi u tfal ta'inqas minn età ta' 4snin, ma ġietx stabbilita.
English: The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Maltese: Il-pazjenti kienu magħżula b'mod każwali biex jieħdu jew carbamazepine CR 400-1200 mg/ġurnata jew levetiracetam 1000-3000 mg/ġurnata, b'trattament li dam sa 12-i1 ġimgħa skont kemm kien ir-rispons.
English: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment.
Maltese: Każijiet rari ta' tnaqqis fl-għadd taċ-ċelluli tad-demm (newtropenija, agranuloċitożi, lewkopenija, tromboċitopenija u panċitopenija) ġew deskritti f'assoċjazzjoni mal-għoti ta' levetiracetam, ġeneralment fil-bidu tal-kura.
English: Hepatic failure, hepatitis
Maltese: Nekrolisi epidermali tossika,
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of
Maltese: Fi studju li jirrifletti l-prattika klinika, l-mediċini ta' kontra l-epilessija li ngħataw fl-istess ħin setgħu jiġu mwaqqfa f'numru limitat ta' pazjenti li rrispondew għal terapija miżjuda b'levetiracetam (36 pazjent minn 69).
English: nasopharyngitis (infection of the nose or throat); somnolence (sleepiness), headache.
Maltese: • nasofarinġite (infezzjoni fl-imnieħer jew il-griżmejn);
English: Levetiracetam Hospira concentrate for solution for infusion is packed in a cardboard box containing 10 or 25 vials of 5 ml.
Maltese: Levetiracetem Hospira konċentrat għal soluzzjoni għall-infużjoni huwa ppakkjat f'kaxxa tal-kartun li fiha 10 jew 25 kunjett ta 5ml.
English: Levetiracetam is excreted in human breast milk.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance for clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Maltese: F'livelli ta' esponiment simili ta' dik fil-bniedem, effetti avversi li ma ġewx osservati fl-istudji kliniċi imma osservati fil-firien u f'livelli inqas fil-ġurdien u b'rilevanza possibbli għal użu kliniku kienu bidliet fil-fwied li jindika rispons adattiv żieda fil-piż u ipertrofija ċentrilobulari, infiltrazzjoni ta' xaħam u żieda fl-enżimi tal-fwied fil-plażma.
English: Concentrate for solution for infusion (sterile concentrate).
Maltese: Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili)
English: Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Maltese: L-effikaċja ta' levetitacetam bħala monoterapija ġiet stabbilita fi studju double-blind, fi grupp parallel, mhux ta' inferjorità ma' carbamazepine f'għamla li jintreħa b'mod kontrollat (CR) f'576 pazjent ta' 16-il sena jew iżjed li għadhom kif ġew dijanjostikati b'epilessija.
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1,800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Maltese: Ebda reazzjonijiet avversi fuq il-fertilità maskili jew femminili jew prestazzjoni riproduttiva ma kienu osservati fil-firien f'dożi sa 1800 mg/kg/day (x 6 l-MRHD fuq bażi ta' mg/m2 jew ta' esponiment)
English: As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Maltese: Bħal fil-każ tal-mediċini kollha kontra l-epilessija, it-twaqqif f'daqqa ta' levetiracetam għandu jiġi evitat, għaliex dan jista' jwassal għal attakki ta' epilessija mhux mistennija li jista' jkollhom konsegwenzi serji għall-mara u t-tarbija mhux imwielda.
English: If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Maltese: • Jekk inti allerġiku għal levetiracetam, derivattivi ta' pyrrolidone jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-Sezzjoni 6).
English: 250 mg 2.5 ml (half 5 ml vial) 100 ml
Maltese: Doża Totali ta' Kuljum250 mg 2.5 ml (nofs kunjett ta' 5 ml)
English: Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
Maltese: L-effiċjenza ta' levetiracetam dehret fi studju double-blind ikkontrollata minn plaċebo fi studju li dam 16-il ġimgħa, f'pazjenti ta' 12-il sena jew iżjed li jbatu minn epilessija ġeneralizzata idjopatika b'aċċessjonijiet mijokloniċi b'sindromi differenti.
English: as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
Maltese: Terapija aġġuntiva fit-trattament ta' aċċessjonijiet tat-tip parzjali kemm b'ġeneralizazzjoni sekondarja kif ukoll mingħajr f'adulti, adolexxenti u tfal minn 4 snin b'epilessija.
English: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite, but not of levetiracetam.
Maltese: Madankollu, studji epidemjoloġiċi kurrenti (fuq madwar 100 tifel u tifla) ma jissuġġerux żieda fir-riskju ta' disturbi ta' jew dewmien fl-iżvilupp newroloġiku.
English: Since there was limited exposure for levetiracetam intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of levetiracetam intravenous will rely on levetiracetam oral use.
Maltese: Peress li kien hemm esponiment limitat għal levetiracetam li ngħata minn ġol-vina u peress li l-formulazzjonijiet li tingħata ġol-vina u dik orali huma bijoekwivalenti, l-informazzjoni ta' sigurtà ta' levetiracetam li jingħata minn ġol-vina ser joqgħod fuq l-użu orali ta' levetiracetam
English: • swelling of the face, lips, tongue and throat (Quincke's oedema)
Maltese: • nefħa tal-wiċċ, tax-xufftejn, tal-ilsien jew tal-gerżuma (edema ta' Quincke)
English: The mean total body clearance was 0.96 ml/min/kg.
Maltese: Ir-rata medja li biha jitneħħa għall-kollox kienet ta' 0.96 ml/min/kg.
English: Levetiracetam elimination is correlated to creatinine clearance.
Maltese: L-eliminazzjoni ta' levetiracetam tikkorelata mat-tneħħija tal-kreatinina.
English: The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Maltese: Il-profil ta' reazzjonijiet avversi ta' levetiracetam huwa ġeneralment simili fil-gruppi kollha ta' letajjiet (adulti u pażjenti pedjatriċi) u fl-indikazzjonijiet approvati ta' epilessija kollha.
English: Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Maltese: Żiediet lineari u proporzjonali għad-doża kienu osservati bil-konċentrazzjonijiet massimi fil-plażma u l-erja taħt il-kurva.
English: Levetiracetam Hospira concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic levetiracetammedicine by mouth is temporarily not feasible.
Maltese: Il-konċentrat ta' Levetiracetem Hospira huwa alternattiva għal pazjenti li temporanjament ma' jistgħux jieħdu mediċina mill-ħalq.
English: 600 mg twice daily
Maltese: 200 mg darbtejn kuljum 600 mg darbtejn kuljum25 kg
English: • a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Maltese: • raxx tal-ġilda li jista' jifforma nfafet li jidhru qishom miri żgħar (tikek skuri ċentrali mdawrin minn żona aktar pallida, b'ċirku skur madwar ix-xifer) (eritema multiforme)
English: • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
Maltese: • attentat ta' suwiċidju jew ħsibijiet ta' suwiċidju, disturbi mentali, imġieba abnormali, alluċinazzjoni, rabja, konfużjoni, attakki ta' paniku, instabilità emozzjonali, bidliet bil-burdata, aġitazzjoni;
English: In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Maltese: Kienu wkoll identifikati żewġ prodotti tal-metaboliżmu inqas importanti.
English: Package size l t o r
Maltese: Mnejn jingħata Il-pakkett
English: Pack size
Maltese: Daqs talPakkett
English: Route of administration
Maltese: 30 qaertas
English: respectively).
Maltese: rispettivament).
English: (See sections 4.5 and 5.2.)
Maltese: (ara taqsimiet 4.5 u 5.2).
English: Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Maltese: Hvězdova 1716/2b, 140 78 Praha 4 Ir-Repubblika Ċeka
English: Magnesium stearate
Maltese: Crospovidone Magnesium stearate
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjent
English: Parkinsonism6 Dyskinesia6
Maltese: Parkinsoniżmu6 Diskineżja6
English: LIST OF EXCIPIENTS Contains aspartame.
Maltese: LISTA TA' ĊĊIPJENTI Fiha aspartame.
English: (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l - < 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Maltese: (≥ 1.467 mmol/l) u tibdil fit-trigliċeridi waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 1.016 mmol/l - < 1.467 mmol/l) għal għoljin (≥ 1.467 mmol/l).
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Maltese: Olanzapine ma jinibixxix l-iżoenżimi CYP450 prinċipali in vitro (eż 1A2, 2D6, 2C9, 2C19, 3A4).
English: Olazax Disperzi with alcohol
Maltese: Olazax Disperzi mal-alkohol
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olazax Disperzi dose.
Maltese: • Carbamazepine (anti-epilettiku u stabilizzatur tal-burdata), fluvoxamine (anti-dipressant), jew ciprofloxacin (antibijotiku), għax jista' jkun hemm bżonn li tbiddel id-doża tiegħek ta' Olazax
English: Elevated cholesterol levels2,3
Maltese: kolesterol2,3
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: 'dati ta' referenza tal-Unjoni (lista EURD) previsti fl-Artikolu 107c (7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-web-portal.
English: Olazax Disperzi 5mg, 7.5 mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28, 56 orodispersible tablets
Maltese: Olazax Disperzi 5 mg, 7.5 mg, 10 mg, 15 mg u 20 mg jiġu f'folji tal-fojl tal-aluminju ta' 28 & 56
English: Investigations Elevated plasma prolactin levels 8
Maltese: Investigazzjonijiet Livelli elevati ta' prolactin fil-plażma 8
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 10,000), not known (cannot be estimated from the data available).
Maltese: komuni ( > 1/100 sa < 1/10), mhux komuni ( > 1/1,000 sa < 1/100), rari ( > 1/10,000 sa < 1/1,000, rari ħafna ( < 1/10,000), mhux magħrufa (ma jistgħux jiġu stmati mill-informazzjoni li hemm disponibbli).
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Maltese: Kategorija farmakoterapewtika: psikolettiċi, diazepines, oxazepines, thiazepins u oxepines, kodiċi
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n = 467) as in male patients (n = 869).
Maltese: Madankollu, olanzapine (5-20 mg) wera profil ta' sigurtà kumparabbli f'pazjenti nisa (n=467) u f'pazjenti rġiel
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Maltese: Olanzapine hija fil-biċċa 'l kbira marbuta mal-albumina u α1-aċidglycoprotein.
English: Olazax Disperzi contains aspartame
Maltese: Olazax Disperzi fih Aspartame:
English: Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite.
Maltese: Komuni ħafna: Żieda fil-piż13, livelli elevati ta' trigliċeridi14, żieda fl-aptit.
English: Neuroleptic malignant syndrome (see section 4.4)12
Maltese: Sindromu Newrolettiku Malinn (ara taqsima 4.4)12
English: Store below 30 C.
Maltese: Aħżen f'temperatura ta' inqas minn 30°C.
English: There were more smokers among subjects with cirrhosis (4/6; 67 %) than among subjects with no hepatic dysfunction (0/3; 0 %).
Maltese: Kien hemm aktar nies li jpejpu fost is-suġġetti b'ċirrożi (4/6; 67 %) milli fost is suġġetti li ma kellhom ebda disfunzjoni epatika (0/3; 0 %).
English: Date of first authorisation: 10.12.2009 Date of renewal of authorisation: 06.08.2014
Maltese: 12.2009 Data tal-aħħar tiġdid: 10.
English: Mannitol (E 421) Microcrystalline cellulose Aspartame (E 951) Crospovidone Magnesium stearate
Maltese: Microcrystalline cellulose Aspartame E 951
English: Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton.
Maltese: Folji ta' aluminju/aluminju f'kartun ta' 28 & 56 pillola għal kull kartuna.
English: Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Maltese: Id-differenzi demografiċi bejn l-adolexxenti u l-adulti jinkludu medja anqas ta'
English: In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1 % to 1 %) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Maltese: QTcF < 500 msek) ma kienux komuni (0.1% sa 1%) f'pazjenti kkurati b'olanzapine, b'ebda differenza sinifikattiva fl-avvenimenti assoċjati kardijaċi meta mqabbla ma' plaċebo.