FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin of male genital organs Prior to injection of local anaesthetics
Maltese: Qabel l-injezjoni ta' anestetiċi lokali Ġilda tal-organi ġenitali femminili
English: After a 5-10 minute application of EMLA to female genital mucosa the average duration of effective analgesia to an argon laser stimulus, which produced a sharp, pricking pain was 15-20 minutes (individual variations in the range 5-45 minutes).
Maltese: analġeżija effikaċi għal stimulu tal-lejżer tal-argon, li pproduċiet uġigħ qawwi bi qris kien ta' 15-20 minuta
English: Reproduction toxicity has been shown with subcutaneous/intramuscular administration of high doses of lidocaine or prilocaine much exceeding the exposure from topical application (see section 5.3).
Maltese: Tossiċità fir-riproduzzjoni ntweriet b'amministrazzjoni taħt il-ġilda/fil-muskoli ta' dożi għoljin ta' lidocaine jew prilocaine ħafna aktar millespożizzjoni minn applikazzjoni topikali (ara sezzjoni 5.3).
English: The maximum observed plasma concentration for lidocaine, monoglycinexylidide and 2,6-xylidine were 0.41, 0.03 and 0.01 µg/mL respectively.
Maltese: Il-konċentrazzjoni massima osservata fil-plażma għal lidocaine, monoglycinexylidide u 2,6
English: Increasing the ulcer area by 1 cm2 results in an increased Cmax for the sum of lidocaine and prilocaine concentrations of 7.2 ng/mL.
Maltese: Jekk iż-żona tal-ulċera tiżdied b'1 cm2, dan jirriżulta f'żieda fis-Cmax għat-total tal-konċentrazzjonijiet ta' lidocaine u prilocaine ta' 7.2 ng/mL.
English: o superficial surgical procedures; in adults and in the paediatric population
Maltese: f'adulti u fil-popolazzjoni pedjatrika
English: [To be completed nationally]
Maltese: (ara d-dettalji taħt)
English: Prior to cervical curettage
Maltese: Qabel curettage ċervikali
English: Application site oedema 1, 2, 3
Maltese: Edema fis-sit talapplikazzjoni1, 2, 3
English: • Topical anaesthesia of the skin in connection with:
Maltese: • Anesteżija topikali tal-ġilda f'konnessjoni ma':
English: Animals with an intact tympanic membrane, however, show no abnormality when exposed to EMLA in the external auditory canal.
Maltese: Madankollu, annimali b'membrana timpanika sħiħa, ma juru ebda abnormalità meta esposti għal EMLA fil-kanal awditorju estern.
English: Therefore, a decrease in clearance, such as in patients with severely impaired liver function, has limited effects on the systemic plasma concentrations after a single dose of EMLA, and after single doses repeated once daily short term (up to 10 days).
Maltese: Għalhekk, tnaqqis fit-tneħħija, bħal f'pazjenti b'funzjoni tal-fwied indebolità sew, għandu effetti limitati fuq il-konċentrazzjonijiet sistemiċi fil-plażma wara doża unika ta' EMLA, u wara dożi uniċi ripetuti darba kuljum fi żmien qasir (sa 10 ijiem).
English: The cream is put on under a dressing.
Maltese: - Il-krema titpoġġa taħt dressing.
English: The quality of anaesthesia depends upon the application time and the dose.
Maltese: Il-kwalità tal-anesteżija tiddependi fuq il-ħin ta' applikazzjoni u d-doża.
English: Rare cases of clinically significant methaemoglobinaemia have been reported.
Maltese: Ġew irrapportati każijiet rari ta' metemoglobinemija klinikament sinifikanti.
English: Because of thin facial skin and high tissue blood flow, maximal local anaesthetic effect is obtained after 30-60 minutes on the forehead and on the cheeks.
Maltese: Minħabba ġilda tal-wiċċ irqiqa u fluss tad-demm għoli fit tessut, l-effett anestetiku lokali massimu jinkiseb wara 30-60 minuta fuq il-moħħ u l-ħaddejn.
English: The maximum plasma concentrations of lidocaine and prilocaine after application of EMLA in paediatric patients of different ages were also below potentially toxic levels.
Maltese: Il-konċentrazzjonijiet massimi fil-plażma ta' lidocaine u prilocaine wara l-applikazzjoni ta' EMLA f'pazjenti pedjatriċi ta' etajiet differenti, kienu wkoll taħt il-livelli potenzjalment tossiċi.
English: Procedure
Maltese: LISTA
English: Leg ulcer Following a single application of 5 to 10 g of EMLA to leg ulcers with an area of up to 64 cm2 for 30
Maltese: Wara applikazzjoni ripetuta ta' 2-10 g EMLA fl-ulċeri tar-riġlejn b'żona sa 62 cm2 għal 30-60 minuta 3
English: Application times of longer than 30 minutes in patients with atopic dermatitis may result in an increased incidence of local vascular reactions, particularly application site redness and in some cases petechia and purpura (see section 4.8).
Maltese: Ħinijiet ta' applikazzjoni ta' iktar minn 30 minuta f'pazjenti b'dermatite atopika jistgħu jirriżultaw f'inċidenza ta' reazzjonijiet vaskulari lokali miżjuda, partikolarment ħmura fiż-żona tal-applikazzjoni u f'ċertu każijiet tbenġil u purpura (ara sezzjoni 4.8).
English: Following repeated application of 10 g EMLA to chronic leg ulcers with an area between 62-160 cm2 for 60 minutes once daily during 10 consecutive days, the mean maximum plasma concentration of the sum of lidocaine and prilocaine concentrations was 0.6 µg/mL.
Maltese: Wara applikazzjoni unika ta' 5 sa 10 g ta' EMLA fuq l-ulċeri fir-riġlejn b'żona sa 64 cm2 għal 30 minuta, il konċentrazzjonijiet massimi fil-plażma ta' lidocaine (medda ta' 0.05-0.25 µg/mL, valur individwali wieħed ta' 0.84 µg/mL) u ta' prilocaine (0.
English: A thick layer of EMLA should be applied to the skin, including genital skin, under an occlusive dressing.
Maltese: Saff oħxon ta' EMLA għandu jiġi applikat fuq il-ġilda, inkluż ġilda ġenitali, taħt dressing oklussiva.
English: Application site warmth 2, 3
Maltese: Ħakk fis-sit talapplikazzjoni 2, 3
English: The major elimination pathway of lidocaine and prilocaine is via hepatic metabolism and metabolites are renally excreted.
Maltese: Il-mogħdija ewlenija ta' eliminazzjoni ta' lidocaine u prilocaine hija permezz tal-metaboliżmu epatiku u l-metaboliti huma eliminati mill-kliewi.
English: Clinical data from a longer waiting period are not available.
Maltese: o proċeduri kirurġiċi superfiċjali;
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ [Ara Anness I - Li għandha timtela fuq livell nazzjonali]
English: The table is based on adverse events reported during clinical trials, and/or post-marketing use.
Maltese: It-tabella hija bbażata fuq avvenimenti avversi rappurtati waqt provi kliniċi, u/jew użu wara t-tqegħid fis-suq.
English: if you are allergic to lidocaine or prilocaine, other similar local anaesthetics or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tużax EMLA - inti allerġiku/a għal lidocaine jew prilocaine, anastetiku lokali simili ieħor jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: Genital mucosa
Maltese: Tfal u adolexxenti
English: Newborn infants and infants 0-2
Maltese: Adulti, Adolexxenti u Tfal
English: Patients treated with anti-arrhythmics of class III (e.g. amiodarone) should be carefully monitored and ECG monitoring considered, as cardiac effects may be additive.
Maltese: Pazjenti trattati b'anti-arritmiċi ta' klassi III (eż. amiodarone) għandhom jiġu ssorveljati b'attenzjoni u għandha tiġi kkunsidrata sorveljanza b'ECG, minħabba li effetti kardijaċi jistgħu jkunu addittivi.
English: Eleven clinical studies in newborn infants and infants showed that peak methaemoglobin concentrations occur about 8 hours after epicutaneous EMLA administration, are clinically insignificant with recommended dosage, and return to normal values after about 12-13 hours.
Maltese: Ħdax-il studju kliniku fi trabi tat-twelid u fi trabi wrew li l-ogħla konċentrazzjonijiet ta' methaemoglobin iseħħu madwar 8 sigħat wara l-għoti ta' EMLA epikutanju, huma klinikament insinifikanti bid-doża rakkomandata, u jerġgħu lura għal valuri normali wara madwar 12-13-il siegħa.
English: A mild reaction (paleness or redness of the skin, slight puffiness, initial burning or itching) may occur on the area on which EMLA is used.
Maltese: Reazzjoni ħafifa (bjudija jew ħmura tal-ġilda, nefħa ħafifa, ħruq jew ħakk tal-bidu) tista' sseħħ fuq il-parti li fuqha qed jintuża EMLA.
English: Cutaneous use
Maltese: TAL-PRODOTT
English: The use of EMLA prior to measles-mumps-rubella or intramuscular diphtheria-pertussis-tetanusinactivated poliovirus-Haemophilus influenzae b or Hepatitis B vaccines does not affect mean antibody titres, rate of seroconversion, or the proportion of patients achieving protective or positive antibody titres post immunization, as compared to placebo treated patients.
Maltese: Għal applikazzjoni għal partijiet kbar, bħal grafting ta' ġilda maqsuma, għandha tiġi applikata faxxa elastika fuq id-dressing okklussiva biex tagħti distribuzzjoni ugwali ta' krema u tipproteġi ż-żona.
English: Care should be taken when applying EMLA to patients with atopic dermatitis.
Maltese: Għandha tingħata attenzjoni meta jiġi applikat EMLA lil pazjenti b'dermatite atopika.
English: Children 6-11 years
Maltese: Tfal 6-11-il sena
English: o needle insertion, e.g. intravenous catheters or blood sampling;
Maltese: - Qatgħat, grif jew feriti, inkluż ulċeri tas-saqajn.
English: The most frequently observed adverse drug reactions (ADRs) are related to administration site conditions (transient local reactions at the application site), reported as common.
Maltese: L-iktar reazzjonijiet avversi tal-mediċina (ADRs) li ġew osservati b'mod frekwenti huma relatati mal kundizzjoni tal-parti tal-amministrazzjoni (reazzjonijiet lokali temporanji fil-parti tal-applikazzjoni),
English: Patients with defective glucose-6-phosphate dehydrogenase hereditary or idiopathic methaemoglobinaemia are more susceptible to active-substance-induced signs of methaemoglobinaemia.
Maltese: Testijiet fuq annimali tal-laboratorju urew li EMLA għandu effett ototossiku meta mdaħħal fil-parti tan-nofs tal-widna.
English: EMLA is equally effective and has the same anaesthetic onset time across the range of light to dark pigmented skin (skin types I to VI).
Maltese: EMLA huwa ugwalment effikaċi u għandu l-istess ħin tal-bidu anestetiku fil-medda ta' ġilda pigmentata ċara sa skura (tipi ta' ġilda I sa VI).
English: Plasma concentrations of lidocaine and prilocaine in both geriatric and non-geriatric patients following application of EMLA to intact skin are very low and well below potentially toxic levels.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' lidocaine u prilocaine fil-pazjenti ġerjatriċi u mhux ġerjatriċi wara lapplikazzjoni ta' EMLA fuq ġilda intatta huma baxxi ħafna u ferm aktar baxxi minn livelli potenzjalment tossiċi.
English: Application site pruritus1
Maltese: L-Awstrija
English: Skin and subcutaneous tissue disorders
Maltese: Ġilda tal-organi ġenitali maskili
English: This is done for 15 minutes on male genital skin and for 60 minutes on female genital skin.
Maltese: Dan isir għal 15-il minuta fuq ġilda ġenitali tal-irġiel u għal 60 minuta fuq ġilda ġenitali tan-nisa.
English: 10 g/100 cm2
Maltese: 4 sigħat sentejn - 3 snin 10 g/100 cm2
English: EMLA reduces the number of cleansing sessions required to achieve a clean ulcer compared to debridement with placebo cream.
Maltese: EMLA jnaqqas in-numru ta' sessjonijiet ta' tindif meħtieġa biex tinkiseb ulċera nadifa meta mqabbel ma' debrajdment bi krema bi plaċebo.
English: Summary of the safety profile
Maltese: .8 Effetti mhux mixtieqa Sommarju tal-profil tas-sigurtà
English: How to store EMLA
Maltese: Jekk tieħu aktar EMLA milli suppost
English: Prior to removal of mollusca
Maltese: Qabel it-tneħħija tal-molluska
English: EMLA can be used during breastfeeding if clinically needed.
Maltese: EMLA jista' jintuża waqt it- treddigħ jekk ikun klinikament meħtieġ.
English: Smooth down the edges of the dressing carefully.
Maltese: Illixxja t-truf tad-dressing b'attenzjoni.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 June 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ġunju 2017
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/119)
Maltese: Riżultat ta' proċedura ta' referenza skont l-Artikolu 35 tadDirettiva 2001/82/KE (EMEA/V/A/119)
English: Methylprednisolone hydrogen succinate is an ester of the synthetic glucocorticoid methylprednisolone.
Maltese: Metilprednisolon idroġenu suksinat huwa ester ta' metilprednisolon glukokortikojde sintetiku.
English: What are the conclusions of the CVMP?
Maltese: X' inhuma l-konklużjonijiet tas-CVMP?
English: On 2 May 2016, Germany initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned products.
Maltese: Fit-2 ta' Mejju 2016, il-Ġermanja bdiet proċedura ta' referenza skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti msemmija qabel.
English: In the absence of product-specific residue depletion data or any other information concerning residues of veterinary medicinal products containing methylprednisolone hydrogen succinate, the CVMP considered the available residue depletion data used for the establishment of maximum residue limits for methylprednisolone (EMEA/MRL/798/01)1.
Maltese: Fin-nuqqas ta' data dwar it-tnaqqis tar-residwi speċifika għall-prodott jew kwalunkwe informazzjoni oħra dwar residwi ta' prodotti mediċinali veterinarji li fihom metilprednisolon idroġenu suksinat, isCVMP ikkunsidra d-data dwar it-tnaqqis tar-residwi disponibbli użata biex jiġu stabbiliti livelli massimi ta' residwi għal metilprednisolon (EMEA/MRL/798/01)
English: What is methylprednisolone hydrogen succinate?
Maltese: X' inhu metilprednisolon idroġen suksinat?
English: Why were veterinary medicinal products containing methylprednisolone hydrogen succinate reviewed?
Maltese: Għaliex ġew rieżaminati l-prodotti mediċinali veterinarji li fihom metilprednisolon idroġenu suksinat?
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and offal) for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
Maltese: Fis-16 ta' Marzu 2017, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet rieżami dwar is-sigurtà tal-konsumatur tal-perjodi tal-irtirar għal frat (laħam u ġewwieni tal-annimal) għal prodotti mediċinali veterinarji li fihom metilprednisolon idroġenu suksinat li huma ppreżentati bħala soluzzjonijiet għallinjezzjoni.
English: Germany considered that the withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products might not be sufficient to ensure consumer safety.
Maltese: Il-Ġermanja kkunsidrat li l-perjodu tal-irtirar ta' 6 ijiem għall-frat (laħam u ġewwieni tal-annimal) ikkurati bi prodotti li fihom metilprednisolon idroġenu suksinat jista' ma jkunx biżżejjed biex jiżgura s-sigurtà tal-konsumatur.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal).
Maltese: Abbażi tal-valutazzjoni tad-data disponibbli bħalissa, is-CVMP ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju għal prodotti mediċinali veterinarji li fihom metilprednisolon idroġenu suksinat li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni mhuwiex favorevoli minħabba n-nuqqas ta' data dwar it-tnaqqis tar-residwi adegwata sabiex tiġġustifika perjodu tal-irtirar ta' 6 ijiem għall-frat (laħam u ġewwieni tal-annimal).
English: The European Commission issued a decision on 20 June 2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fl-20 ta' Ġunju 2017.
English: The CVMP recommended the refusal of the granting of a marketing authorisation for the target species cattle and variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection.
Maltese: Il-Kumitat irrakkomanda r-rifjut tal-għoti talawtorizzazzjoni għat-tqegħid fis-suq għall-frat l-ispeċi fil-mira u l-varjazzjoni għall-awtorizzazzjonijiet għat-tqegħid fis-suq eżistenti sabiex titneħħa kwalunkwe referenza għall-frat l-ispeċi fil-mira għal prodotti mediċinali veterinarji li fihom metilprednisolon idroġenu suksinat.
English: 2 Safety
Maltese: 2 Sikurezza
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for valproic acid/valproate containing medicinal products initiated by The Netherlands.
Maltese: - Il-Kumitat ikkunsidra r-referenza magħmula skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għal valproic acid/prodotti mediċinali li fihom valproate li ġiet inizjata mill-Olanda.
English: Overall Safety
Maltese: SOMMARJU GLOBALI
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALPROIC ACID/VALPROATE CONTAINING PRODUCTS (see Annex I)
Maltese: TAL-PRODOTTI LI FIHOM VALPROIC ACID/VALPROATE (ara l-Anness I)
English: In the two-arm study performed by Calabrese and co-workers (2005), patients in the valproate group performed better in several efficacy parameters compared to the lithium group (in a statistically nonsignificant way), however significantly more patients in the lithium group experienced various adverse effects (tremor, polyuria, polydipsia) compared to the valproate group.
Maltese: Fl-istudju b'żewġ fergħat imwettaq minn Calabrese u ko-ħaddiema (2005), il-pazjenti fil-grupp ta' valproate kellhom prestazzjoni aħjar f'bosta parametri tal-effikaċja meta mqabbla mal-grupp ta' litju (b'mod li huwa statistikament mhux sinifikanti), madankollu ħafna aktar pazjenti fil-grupp ta' litju kellhom effetti avversi varji (rogħda, polyuria, polydipsia) meta mqabbla mal-grupp ta' valproate.
English: The scientific conclusions of the CHMP Opinion of 17 Decemeber 2009 were revised accordingly.
Maltese: Il-konklużjonijiet xjentifiċi tal-Opinjoni tas-CHMP tas-17 ta' Diċembru 2009 ġew riveduti bix-xieraq.
English: 2.2 Risk Management Plan
Maltese: 2.2 Pjan tal-Ġestjoni tar-Riskji
English: - The Committee considered the grounds for re-examination submitted by various MAHs for valproic acid/valproate containing medicinal products on 13 April 2010 and the discussion within the Committee;
Maltese: - Il-Kumitat ikkunsidra r-raġunijiet għall-eżaminazzjoni mill-ġdid sottomessi mill-MAHs varji għal valproic acid/prodotti mediċinali li fihom valproate fit-13 ta' April 2010 u d-diskussjoni fi ħdan il-Kumitat;
English: In addition, the time to recurrence of manic events has not shown statistically significant differences.
Maltese: Barra minn hekk, il-ħin għar-rikorrenza tal-avvenimenti manijaċi ma weriex differenzi statistikament sinifikanti.
English: It was highlighted that although the indication exists in many Member States, sustained efficacy both in acute mania as well as in the prevention of recurrence of mood episodes has not been clearly demonstrated in well designed clinical trials which comply with the requirements of the CPMP Note for Guidance on Clinical Investigation of Medicinal products for the Treatment and Prevention of Bipolar Disorder (CPMP/EWP/567/98).
Maltese: Ġie enfasizzat li għalkemm l-indikazzjoni teżisti f'bosta Stati Membri, l-effikaċja sostnuta kemm fil-manija akuta kif ukoll fil-prevenzjoni tarrikorrenza ta' episodji tal-burdata ma ntweritx b'mod ċar fi provi kliniċi mfasslin tajjeb li jikkonformaw mar-rekwiżiti tan-Nota ta' Gwida tas-CPMP dwar l-Investigazzjoni Klinika tal-prodotti Mediċinali għat-Trattament u l-Prevenzjoni tad-Disturb Bipolari (CPMP/EWP/567/98).
English: The MAHs for valproic acid/valproate authorised products applying to the new indication should submit a Risk Management Plan to the the national competent authorities (NCAs) of the respective member states.
Maltese: Il-MAHs għal valproic acid/prodotti mediċinali li fihom valproate li japplikaw għall-indikazzjoni lġdida għandhom jissottometti Pjan tal-Ġestjoni tar-Riskji lill-awtoritajiet kompetenti nazzjonali (AKNs) tal-Istati Membri rispettivi.
English: Whereas, in the original analysis time to recurrence of any mood episode or depressive episode, respectively was not significantly different in the three treatment groups, post-hoc analyses showed that valproate treated patients dropped out significantly less frequent than placebo treated patients due to a mood episode, whereas the respective difference was not statistically significant compared to lithium treated patients.
Maltese: Filwaqt li, fl-analiżi oriġinali, il-ħin għar-rikorrenza ta' kwalunkwe episodju tal-burdata jew episodju depressiv, rispettivament ma kienx differenti b'mod sinifikanti fit-tliet gruppi ta' trattament, l-analiżi post-hoc urew li l-pazjenti trattati b'valproate ħarġu mill-istudju b'mod ferm inqas frekwenti mill-pazjenti trattati b'plaċebo minħabba episodju tal-burdata, filwaqt li d-differenza rispettiva ma kinitx statistikament sinifikanti meta mqabbla mal-pazjenti li ġew ittrattati b'litju.
English: - The Committee concluded that valproic acid/valproate containing medicinal products have a positive benefit-risk ratio in the proposed amended indication “treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Maltese: - Il-Kumitat ikkonkluda li valproic acid/prodotti mediċinali li fihom valproate għandhom proporzjon pożittiv tal-benefiċċji/riskji fl-indikazzjoni emendata proposta “trattament ta'
English: Taking into account that in different EU member States the authorised valproate products may have or not the indication for the bipolar disorder the CHMP agreed with the following:
Maltese: Wara li kkunsidra li fi Stati Membri diversi tal-UE, il-prodotti ta' valproate awtorizzati jista' jkollhom l-indikazzjoni għad-disturb bipolari jew le, is-CHMP qabel ma' li ġej:
English: In 2008, in light of the results of the US FDA meta-analysis of clinical trial data for antiepileptics, and in light of the spontaneous and literature reports, the Pharmacovigilance Working Party concluded that any antiepileptic drug may be associated with a low risk of suicidal thoughts and behaviour.
Maltese: Fl-2008, fid-dawl tar-riżultati tal-meta-analiżi tal-US FDA tad-dejta tal-provi kliniċi għallantiepilettiċi, u fid-dawl tar-rapporti spontanji u dokumentati, il-Grupp ta' Ħidma għallFarmakoviġilanza kkonkluda li kwalunkwe mediċina antiepilettika tista' tiġi assoċjata ma' riskju baxx ta' ideat u mġiba ta' suwiċidju.
English: The CHMP agreed that the recommendations are applicable to all oral use formulations.
Maltese: Għal raġunijiet teoretiċi, il-formulazzjonijiet ta'
English: The continuation of treatment after manic episode could be considered in patients who have responded to the medicinal product for acute mania”.
Maltese: Il kontinwazzjoni tal-kura wara episodju ta' manija tista' tiġi kkunsidrata f'pazjenti li jkunu rrispondew għall-prodott mediċinali f'manija akuta”.
English: - The Committee concluded that the Product Information of all valproic acid/valproate containing medicinal products should be amended to include information on the treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristic and Package
Maltese: - Il-Kumitat ikkonkluda li l-Informazzjoni dwar il-Prodott ta' valproic acid/prodotti mediċinali li fihom valproate kollha għandhom jiġu emendati sabiex jinkludu informazzjoni dwar it trattament ta' episodju ta' manija f'disturb bipolari meta litju jkun kontra-indikat jew ma jkunx tollerat u għalhekk irrakkomanda l-emendi għas-sezzjonijiet rilevanti tas-Sommarju tal