FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension,
Maltese: Sintomi oħra morbużi ta' doża eċċessiva li huma medicament sinifikanti jinkludu d-delirju, il konvulżjoni, koma, possibilment Sindromu Newrolettiku Malinn, depressjoni respiratorja,
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Maltese: M'hemmx dejta kkontrollata dwar il-manteniment tal-effett jew dwar is-sigurtà fit-tul (ara taqsimiet 4.4 u 4.8).
English: This leaflet was last revised in {month/YYYY}.
Maltese: DATA TA' META ĠIET RIVEDUTA
English: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3 % versus 0.4 %, respectively).
Maltese: f'pazjenti ttattati b'olanzapine, meta mqabblin ma' pazjenti ttrattati bil-plaċebo (1.3% kontra 0.4%,
English: Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Maltese: (jirrapreżenta l-aktar il-passaġġ permezz ta' CYP2D6), warfarina (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
English: Gynaecomastia/breas t enlargement in males
Maltese: Ginekomastija/tkabbir żejjed tas-sider fl-irġiel
English: Olazax 15 mg tablets
Maltese: Olazax 15 mg pilloli
English: Olazax 10 mg tablets
Maltese: Olazax 10 mg pilloli
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Maltese: L-età ta' >75 sena u d demenzja tat-tip vaskulari jew imħallta kienu identifikati bħala fatturi ta' riskju għal CVAE f'assoċjazzjoni ma' trattament b'olanzapine.
English: SmokingIn non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr).
Maltese: F'pazjenti li ma jpejpux f'paragun ma' dawk li jpejpu (irġiel u nisa) il-medja tal-half life ta' l eliminazzjoni kien imtawwal (38.6 kontra 30.4 siegħa) u l-clearance tnaqqset (18.6 kontra 27.7 l/hr).
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5 HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Maltese: Olanzapine wera affinità akbar in vitro għar-riċetturi ta' serotonin 5-HT2 milli ta' dopamine D2 u attività in vivo akbar għal 5-HT2 milli għal D2.
English: (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Maltese: 5.17 - < 6.2 mmol/l) għal għoljin (≥ 6.2 mmol/l) kienu komuni ħafna.
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Maltese: Effetti sekondarji mhux komuni ( jistgħu jaffettwaw sa 1 minn kull 100 persuna) jinkludu sensittività eċċessiva (eż. nefħa fil-ħalq u l-gerżuma, ħakk, raxx);dijabete jew dijabete li tmur għall-agħar, kultant assoċjata ma' ketoaċidożi (ketoni fid-demm u fl-awrina) jew koma; aċċessjonijiet, normalment assoċjati ma' storja ta' aċċessjonijiet (epilessija); ebusija tal-muskoli jew spażmi (inklużi movimenti fl-għajnejn); sindrome ta' saqajn irrekwieti; problemi fil-mod kif titkellem; temtim; il-qalb tħabbat bil-mod; sensittività għad-dawl tax-xemx; tinfaraġ; nefħa fl-addome; telf tal-memorja jew tibda tinsa;
English: Olazax 5 mg tablets
Maltese: Olazax 5 mg pilloli
English: Each tablet contains 7.5 mg olanzapine.
Maltese: Kull pillola fiha 7.5 mg ta' olanzapine.
English: Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7 % from baseline body weight in 39.9 % of patients.
Maltese: Trattament b'olanzapine għal żmien twil (sa 12-il xahar) bl-għan ta' prevenzjoni ta' episodju ieħor f'pazjenti b'mard bipolari kien assoċjat ma' żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem f' 39.9% tal pazjenti.
English: 15Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Maltese: 15 Tibdil fil-livelli tal-kolesterol totali waqt is-sawm minn normal fil-linja bażi (< 4.39 mmol/l) għal għoljin (≥ 5.17 mmol/l) kienu komuni.
English: Dystonia
Maltese: Fertilità
English: The daily dose of Olazax is between 5 mg and 20 mg.
Maltese: Iddoża ta' kuljum ta' Olazax hija bejn 5 mg u 20 mg.
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
Maltese: 5 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.69 mmol/l) li żdiedu għal għoljin (≥
English: Neuroleptic malignant syndrome (see section 4.4) 12
Maltese: Sindromu ta' rtirar mill-mediċina neonatali (ara taqsima 4.6)
English: Excipient with known effect: Each tablet contains 0.69 mg aspartame For the full list of excipients, see section 6.1.
Maltese: Kull pillola fiha 0.69 mg ta' aspartame Għal-lista kompluta ta' eċċipjent, ara sezzjoni 6.1.
English: Reversible neutropenia, thrombocytopenia, or anaemiaa developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Maltese: Newtropenja, tromboċitopenja jew l-anemija riversibbli żviluppaw fi ftit klieb ittrattati b' 8 jew 10 mg/kg/ġurnata (espożizzjoni totali ta' olanzapine [erja taħt il-kurva] hija 12 sa 15-il darba aktar minn dik ta' raġel mogħti doża ta' 12 mg).
English: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during shortterm clinical trials in adolescent patients.
Maltese: It-tabella li ġejja tiġbor fil-qosor ir-reazzjonijiet avversi rrapportati b'frekwenza akbar f'pazjenti adolexxenti (minn 13 sa 17-il sena) milli f'pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta' terminu qasir f'pazjenti adolexxenti.
English: Excipient with known effect: Each tablet contains 0.46 mg aspartame For the full list of excipients, see section 6.1.
Maltese: Kull pillola fiha 0.46 mg ta' aspartame Għal-lista kompluta ta' eċċipjent, ara sezzjoni 6.1.
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor sideeffects.
Maltese: Olanzapine naqqas ir-rispons ta' ħrib kundizzjonat, test indikattiv ta' l-attività antipsikotika, f'dożi anqas minn dawk li jwasslu għall-katalepsi, konsegwenza indikattiva ta' effett motorju mhux mixtieq.
English: Neuroleptic malignant syndrome (see section 4.4)12
Maltese: Malinn (ara taqsima 4.4)12
English: 13Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Maltese: 13 Wara kura għal żmien qasir (medjan ta' tul ta' żmien ta' 22 ġurnata), żieda fil-piż ta' > 7% mil-linja bażi tal-piż tal-ġisem (kg) kienet komuni ħafna (40.6 %), ≥ 15% mil-linja bażi tal-piż tal-ġisem kienet komuni (7.1 %) u ≥ 25 % kienet komuni (2.5 %).
English: Excipient with known effect: Each tablet contains 0.35 mg aspartame For the full list of excipients, see section 6.1.
Maltese: Kull pillola fiha 0.35 mg ta' aspartame Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/597/004
English: Excipient with known effect: Each tablet contains 0.23 mg aspartame For the full list of excipients, see section 6.1.
Maltese: Kull pillola fiha 0.23 mg ta' aspartame Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Maltese: Pazjenti kkurati b'mediċini antipsikotiċi, inkluż ZYPREXA, għandhom ikunu taħt osservazzjoni għal sinjali u sintomi ta' ipergliċemija (bħal polidipsja, polijurja, polifaġja u debbulizza) u pazjenti bid-dijabete mellitus jew li għandhom fatturi ta' riskju għad-dijabete mellitus għandhom jiġu segwiti b'mod regolari f'każ li l-kontroll tal-glukosju jmur għall-agħar.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 7.5 mg olanzapine.
English: NAME OF THE MEDICINAL PRODUCT Olazax 7.5 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Olazax 7.5 mg pilloli
English: 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Maltese: It-tnejn dehru sinifikatament anqas f'attività farmakoloġika in vivo milli olanzapine fi studji fuq l-annimali.
English: Microcrystalline cellulose
Maltese: Kif taħżen Olazax
English: 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Maltese: 1 Ġiet osservata żieda fil-piż klinikament sinifikanti fil-kategoriji kollha fil-linja bażi ta' l-Indiċi talMassa tal-Ġisem (BMI).
English: Breastfeeding
Maltese: MEDIĊINALI
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax.
Maltese: • Livell għoli ta' zokkor fid-demm u livelli għolja ta' xaħmijiet (trigliċeridi u kolesterol) instabu f'pazjenti li qed jieħdu Olazax.
English: Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Maltese: Mutaġeniċità Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f'firxa sħiħata' testijiet standard, li nkludew testijiet ta' mutazzjoni tal-mikrobi kif ukoll testijiet fuq il-mammiferi kemm in vitro kif ukoll in vivo.
English: < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Maltese: 6.2 mmol/l).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Mannitol E 421
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Maltese: B'mod mhux komuni (≥ 0.1% u < 1%) ġiet irrapportata assoċjazzjoni temporali bejn il-kura b'olanzapine u t- tromboemboliżmu fil-vini.
English: categories.
Maltese: D.
English: Dizziness Akathisia6
Maltese: .9 Doża eċċessiva
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Maltese: haloperidol fit-termini tal-proporzjon ta' pazjenti f'remissjoni sintomatika minn manija u depressjoni f'
English: Dysarthria Stuttering11Restle
Maltese: kolestatiku jew tat-tnejn flimkien)11
English: Other medicines and Olazax
Maltese: Mediċini oħra u Olazax
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.emae.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall -Mediċini http://www.ema.europa.eu
English: Amenorrhea Breast enlargement Galactorrhea in females
Maltese: Olanzapine wera wkoll riżultati effikaċji li jistgħu jiġu kumparati ma'
English: Thromboembo lism (including pulmonary embolism and deep vein thrombosis) (see section
Maltese: Epatite (inkluż mard tal-fwied tat tip epatoċellulari,
English: east enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10
Maltese: Popolazzjoni pedjatrika Olanzapine mhux indikat għall-użu fil-kura tat-tfal u adolexxenti.
English: Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
Maltese: aċċessjonijiet (epilessija), koma, taħlita ta' dawn is-sintomi, deni, nifs aktar mgħaġġel, għaraq, ebusija tal-muskoli u ħedla jew ngħas, tnaqqis fil-frekwenza ta' nifsijiet, aspirazzjoni, pressjoni tad-demm għolja jew baxxa, ritmi mhux normali tal-qalb.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC: {numru}
English: Drug withdraw al syndrome neonatal
Maltese: Sindrome ta' Saqajn Irrekwieti
English: Potential for olanzapine to affect other medicinal products
Maltese: Il-potenzjal ta' olanzapine biex jaffetwa prodotti mediċinali oħra
English: NAME OF THE MEDICINAL PRODUCT Olazax 20 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Olazax 20 mg pilloli
English: Vascular disorders Orthostatic hypotension10
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI
English: In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % versus 1.5 %, respectively).
Maltese: darbtejn akbar fl-inċidenza ta' mwiet fil-pazjenti ttrattati b'olanzapine, mqabbla ma' pazjenti ttrattati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: Gynaecomastia/br
Maltese: FULJETT TA' TAGĦRIF
English: ss legs syndrome
Maltese: Sintomi Sistemiċi
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinal tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall -Mediċini http://www.ema.europa.eu
English: Olazax 20 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘F' debossed on other side.
Maltese: Fix-xadini, dożi orali b'wahdiet sa 100 mg/kg irriżultaw f'prostrazzjoni u, f'dożi ogħla, telf parzjali mis-sensi.
English: 6.4 Special precautions for storage Store below 30ºC
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen f'temperatura ta' inqas minn 30°C.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/005
Maltese: FIS-SUQ EU/1/09/597/001 Olazax - 5 mg - Pillola - Użu orali - Folja (alu/alu) - 28 pillola EU/1/09/597/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/597/002
Maltese: FIS-SUQ EU/1/09/597/002 Olazax - 7.5 mg - Pillola - Użu orali - Folja (alu/alu) - 28 pillola EU/1/09/597/007
English: Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartatetransferase (AST) have been seen commonly, especially in early treatment.
Maltese: Livelli għolja ta' aminotransferases tal-fwied, ALT, AST, temporanji u mingħajr sintomi kienu komuni, speċjalment fil-bidu tal-kura.
English: Clinical particulars
Maltese: TAL-PRODOTT MEDIĊINALI
English: Pyrexia10
Maltese: Edima Deni10
English: NAME OF THE MEDICINAL PRODUCT Olazax 10 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Olazax 10 mg pilloli
English: 5.2 Pharmacokinetic propertiesAbsorption
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel.
Maltese: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil u Valhel.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014 EMA/709243/2014
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Meador K, Reynolds MW, Crean S, et al. Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
Maltese: Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
English: In addition, children exposed to valproate in the womb are at an approximately 11% risk of malformations at birth (such as neural tube defects and cleft palate)9 compared with a 2 to 3% risk for children in the general population.
Maltese: Barra minn hekk, tfal li ġew esposti għal valproate fil-ġuf qegħdin f'riskju ta' madwar 11% ta' malformazzjonijiet fit-twelid (bħal difetti fit-tubu newrali u palat mixquq)9 meta mqabbla ma' riskju ta' 2 sa 3% għal tfal fil-popolazzjoni ġenerali.
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Maltese: Mediċini li fihom valproate ġew awtorizzati permezz ta' proċeduri nazzjonali fl-Istati Membri kollha talUE u fin-Norveġja u l-Islanda.
English: Cohen MJ, Meador KJ, Browning N, et al. Fetal antiepileptic drug exposure: motor, adaptive, and emotional/behavioral functioning at age 3 years.
Maltese: Fetal antiepileptic drug exposure: motor, adaptive, and emotional/behavioral functioning at age 3 years.
English: Christensen J, Grønborg TK, Sørensen MJ, et al. Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
Maltese: Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
English: Meador KJ, Penovich P, Baker GA, et al. Antiepileptic drug use in women of childbearing age.
Maltese: 2. Meador KJ, Penovich P, Baker GA, et al.
English: There are also limited data suggesting that children exposed to valproate in the womb may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).6,7,8
Maltese: Hemm ukoll data limitata li tissuġġerixxi li hemm probabbiltà akbar li tfal li ġew esposti għal valproate fil-ġuf jiżviluppaw sintomi ta' disturb ta' nuqqas ta' attenzjoni u iperattività (ADHD).6,7,8
English: Bromley RL, Mawer G, Clayton-Smith J, et al. Autism spectrum disorders following in utero exposure to antiepileptic drugs.
Maltese: 3. Bromley RL, Mawer G, Clayton-Smith J, et al.
English: Cummings C, Stewart M, Stevenson M, et al. Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
Maltese: Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
English: The review of valproate medicines started in October 2013 at the request of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Article 31 of Directive 2001/83/EC, following the publication of new data on the risks of malformations and developmental problems in babies exposed to valproate in the womb.
Maltese: Ir-rieżami ta' mediċini li fihom valproate nbeda f'Ottubru 2013 fuq talba tal-Aġenzija Regolatorja talMediċini u tal-prodotti għall-Kura tas-Saħħa (MHRA) tar-Renju Unit skont l-Artikolu 31 tadDirettiva 2001/83/KE, wara l-pubblikazzjoni ta' dejta ġdida dwar ir-riskji ta' malformazzjonijiet u problemi relatati mal-iżvilupp fi trabi li ġew esposti għal valproate fil-ġuf.
English: Neurology 2008;71(23):1923-4.
Maltese: Neurology 2008;71(23):1923-4. 4. Cummings C, Stewart M, Stevenson M, et al.
English: Thomas SV, Ajaykumar B, Sindhu K, et al. Motor and mental development of infants exposed to antiepileptic drugs in utero.
Maltese: Motor and mental development of infants exposed to antiepileptic drugs in utero.
English: The active ingredients are listed on the packages as valproic acid, sodium valproate, valproate semisodium or valpromide.
Maltese: Is-sustanzi attivi huma elenkati fuq il-pakketti bħala aċidu valproiku, sodju valproate, valproate semisodju jew valpromide.
English: Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study.
Maltese: Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurol 2013;12(3):244-52.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards across the EU for medicines authorised via national procedures.
Maltese: Is-CMDh, korp li jirrappreżenta l-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards armonizzati ta' sigurtà fl-UE kollha għal mediċini awtorizzati permezz ta' proċeduri nazzjonali.
English: Epilepsy Behav 2008 Jul;13(1):229-36.
Maltese: Epilepsy Behav 2008 Jul;13(1):229-36. 6. Christensen J, Grønborg TK, Sørensen MJ, et al.
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Maltese: Mediċini li fihom valproate jintużaw għall-kura ta' epilessija u ta' disturb bipolari.
English: • For treatment of epilepsy and bipolar disorder in female patients who can have children
Maltese: Antiepileptic drug use in women of childbearing age.
English: Epilepsy Behav 2013;29(2):308-15
Maltese: Epilepsy Behav 2013;29(2):308-15 8. Cohen MJ, Meador KJ, Browning N, et al.
English: The review of valproate was conducted by the EMA's Pharmacovigilance and Risks Assessment Committee (PRAC), following which the CMDh endorsed the PRAC's recommendations.
Maltese: Ir-rieżami ta' valproate tmexxamill-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam talFarmakoviġilanza (PRAC) tal-EMA, u wara dan is-CMDh approva r-rakkomandazzjonijiet tal-PRAC.
English: These recommendations follow a review of recent studies showing developmental problems in up to 30 to 40% of pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.1,2,3,4,5
Maltese: Dawn ir-rakkomandazzjonijiet isegwu rieżami ta' studji reċenti li juru problemi relatati mal-iżvilupp f'sa 30 għal 40% tat-tfal qabel l-età tal-iskola li ġew esposti għal valproate fil-ġuf, inkluż li jitkellmu u jimxu tard, problemi bil-memorja, diffikultà fid-diskors u l-lingwa u kapaċità intellettwali aktar baxxa.
English: The CMDh,* a regulatory body representing EU Member States, has agreed to strengthen warnings on the use of valproate medicines in women and girls due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb.
Maltese: Is-CMDh*, korp regolatorju li jirrappreżenta l-Istati Membri tal-UE, qabel li jissaħħu t-twissijiet dwar lużu ta' mediċini li fihom valproate fin-nisa u t-tfajliet minħabba r-riskju ta' malformazzjonijiet u problemi relatati mal-iżvilupp fi trabi li jiġu esposti għal valproate fil-ġuf.