FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall provide relevant healthcare professionals with educational material highlighting important medical risks for which monitoring and/or dose adjustment are recommended, instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal and available data on the relationship between dose and risk of vascular occlusive events.
Maltese: L-MAH għandu jipprovdi lillprofessjonisti tal-kura tas-saħħa rilevanti b'materjal edukattiv li jenfasizza r-riskji mediċi importanti għal liema huma rakkomandati l-monitoraġġ u/jew l-aġġustament fid-doża, l-istruzzjonijiet dwar ilġestjoni ta' avvenimenti avversi bbażati fuq il-monitoraġġ u l-modifikazzjonijiet tad-doża jew lirtirar tal-kura u d-dejta disponibbli dwar ir-relazzjoni bejn id-doża u r-riskju ta' avvenimenti okklużivi vaskulari.
English: There is also an association between vascular occlusive events and a risk of cardiac failure as a secondary event.
Maltese: Hemm ukoll assoċjazzjoni bejn avvenimenti okklużivi vaskulari u riskju ta' insuffiċjenza tal-qalb bħala avveniment sekondarju.
English: However these data include a relatively small number of patients, most of which had been dose reduced due to adverse events, and follow-up time is limited.
Maltese: Madankollu, din id-dejta tinkludi numru relattivament żgħir ta' pazjenti, li ħafna minnhom tnaqqsitilhom id-doża minħabba avvenimenti avversi, u ż-żmien ta' segwitu huwa limitat.
English: • The PRAC considered Iclusig (ponatinib) in the procedure under Article 20 of Regulation (EC) No
Maltese: • Il-PRAC qies Iclusig (ponatinib) fil-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, li nbdiet mill-Kummissjoni Ewropea.
English: The Product Information for Iclusig was revised to include the following:
Maltese: L-Informazzjoni dwar il-Prodott għal Iclusig ġiet riveduta biex tinkludi dan li ġej:
English: A type II variation was submitted and additional risk minimisation measures such as updates to the product information were put in place.
Maltese: Ġiet sottomessa varjazzjoni tat-tip II u ddaħħlu fis-seħħ miżuri addizzjonali ta' minimizzazzjoni tar-riskju bħal aġġornamenti fl-informazzjoni dwar il-prodotti.
English: Therefore the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 27 November 2013.
Maltese: Għalhekk, fis-27 ta' Novembru 2013, il-Kummissjoni Ewropea tat bidu għal proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: In October 2013, the EMA was informed that the rate of vascular occlusive events was higher than observed in the clinical trials that supported the initial marketing authorisation.
Maltese: F'Ottubru 2013, l-EMA ġiet infurmata li r-rata ta' avvenimenti okklużivi vaskulari kienet ogħla milli osservat fil-provi kliniċi li appoġġjaw l-awtorizzazzjoni inizjali għat-tqegħid fis-suq.
English: The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisation for Iclusig should be varied.
Maltese: Is-CHMP, wara li kkunsidra r-rakkomandazzjoni tal-PRAC, jaqbel mal-konklużjonijiet xjentifiċi ġenerali magħmula mill-PRAC u huwa tal-opinjoni li l-awtorizzazzjoni għat-tqegħid fis-suq għal Iclusig għandha tiġi varjata.
English: • The PRAC reviewed all data presented by the MAH on the safety and efficacy of Iclusig, as well as the views expressed by the oncology scientific advisory group.
Maltese: • Il-PRAC irreveda d-dejta kollha ppreżentata mill-MAH dwar is-sigurtà u l-effikaċja ta' Iclusig, kif ukoll il-fehmiet imfissra mill-grupp konsultattiv xjentifiku dwar l-onkoloġija.
English: A dose-ranging study will be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR.
Maltese: Sejjer jitwettaq studju b'doża varjata f'pazjenti b'CP-CML sabiex tiġi ddeterminata d-doża ta' bidu ottimali ta' Iclusig u jiġu kkaratterizzati s-sigurtà u l-effikaċja ta' Iclusig wara tnaqqis fid-doża wara li jkunu kisbu MCyR.
English: Non-clinical issues
Maltese: Kwistjonijiet li mhumiex kliniċi
English: As part of the assessment of potential causes that may lead to an increased occurrence of vascular occlusive events in ponatinib treated patients, molecular mechanisms based on on-target and offtarget effects were discussed.
Maltese: Bħala parti mill-valutazzjoni tal-kawżi potenzjali li jistgħu jwasslu għal żieda fl-okkorrenza ta' avvenimenti okklużivi vaskulari f'pazjenti kkurati b'ponatinib, ġew diskussi mekkaniżmi molekulari bbażati fuq effetti fil-mira u mhux fil-mira.
English: This raises the question of whether similar outcomes in terms of efficacy could be achieved with lower (starting and/or maintenance) doses, which are expected to reduce the risk of vascular occlusive events.
Maltese: Dan iqajjem id-dubju jekk jistgħux jintlaħqu eżiti simili f'termini ta' effikaċja b'dożi (ta' bidu u/jew ta' manteniment) aktar baxxi, li huma mistennija li jnaqqsu r-riskju ta' avvenimenti okklużivi vaskulari.
English: • Additional warnings about hypertension, cardiac failure and risk of bleeding with anti-clotting agents.
Maltese: • Twissijiet addizzjonali dwar pressjoni għolja, insuffiċjenza tal-qalb u riskju ta' fsada b'sustanzi kontra l-koagulazzjoni.
English: The PRAC also recommended that a dose-ranging study be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving major cytogenetic response.
Maltese: Il-PRAC irrakkomanda wkoll li għandu jitwettaq studju b'doża varjata f'pazjenti b'CP-CML sabiex tiġi ddeterminata d-doża tal-bidu ottimali ta' Iclusig u jiġu kkaratterizzati s-sigurtà u l-effikaċja ta' Iclusig wara tnaqqis fid-doża wara li jkunu kisbu rispons ċitoġeniku kbir.
English: The risk of vascular occlusive events is likely to be dose related and therefore a dose reduction would be expected to reduce the risk of vascular occlusive events.
Maltese: Ir-riskju ta' avvenimenti okklużivi vaskulari x'aktarx ikun relatat mad-doża u għalhekk huwa mistenni li tnaqqis fid-doża jnaqqas ir-riskju ta' avvenimenti okklużivi vaskulari.
English: Based on the totality of the data assessed during the procedure and on the advice from the Scientific Advisory Group for oncology, the PRAC concluded that the benefit-risk balance of Iclusig remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
Maltese: Abbażi tat-totalità tad-dejta vvalutata matul il-proċedura u abbażi tal-parir mill-Grupp Konsulattiv Xjentifiku għall-onkoloġija, il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju ta' Iclusig jibqa' wieħed favorevoli, meta wieħed iqis l-emendi fl-informazzjoni dwar il-prodott u soġġett għallmiżuri ta' minimizzazzjoni tar-riskju u l-attivitajiet addizzjonali ta' farmakoviġilanza maqbula.
English: A number of plausible molecular mechanism exists that may contribute to vascular occlusive events.
Maltese: Jeżistu għadd ta' mekkaniżmi molekulari plawżibbli li jistgħu jikkontribwixxu għal avvenimenti okklużivi vaskulari.
English: EMA/256694/2010 rev. EMEA/H/A-6(13)/001190
Maltese: EMEA/H/A-6(13)/001190
English: 30 October 2009, 25 January 2010, 22 February 2010, 26 March 2010
Maltese: 30 ta' Ottubru 2009, 25 ta' Jannar 2010, 22 ta' Frar 2010, 26 ta' Marzu 2010
English: Seroquel XR is an antipsychotic medicine that contains the active substance quetiapine.
Maltese: Seroquel XR huwa mediċina antipsikotika li fiha s-sustanza attiva quetiapine.
English: What is Seroquel XR?
Maltese: X'inhu Seroquel XR?
English: Seroquel XR is authorised in Austria, Belgium, Cyprus, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, and Sweden under a mutual recognition procedure on the basis of the initial authorisation granted by the ‘reference Member State', the Netherlands, in August 2007.
Maltese: Seroquel XR huwa awtorizzat fl-Awstrija, il-Belġju, Ċipru, il-Ġermanja, id-Danimarka, il-Greċja, Spanja, il-Finlandja, l-Irlanda, l-Iżlanda, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, ilPortugall u l-Iżvezja taħt proċedura ta' rikonoxximent reċiproku fuq il-bażi tal-awtorizzazzjoni inizjali mogħtija mill-Istat Membru ta' referenza, il-Pajjiżi l-Baxxi, f'Awwissu 2007.
English: Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine) EMA/256694/2010
Maltese: Mistoqsijiet u tweġibiet dwar Seroquel XR u l-ismijiet assoċjati (50, 150, 200, 300 u 400 mg pilloli b'rilaxx prolongat li fihom quetiapine) EMA/256694/2010
English: Outcome of a procedure under Article 6(13) of Regulation (EC) 1084/2003 as amended
Maltese: Riżultat ta' proċedura skont l-Artikolu 6(13) tar-Regolament (KE) 1084/2003 kif emendat
English: However, Astra Zeneca was not in agreement with the grounds for refusal and, on 22 May 2009, it referred the matter to the CHMP for arbitration.
Maltese: Madankollu, Astra Zeneca ma qablitx mar-raġunijiet għar-rifjut u, fit-22 ta' Mejju 2009, irriferiet ilkwistjoni lis-CHMP għal arbitraġġ.
English: Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine)
Maltese: Mistoqsijiet u tweġibiet dwar Seroquel XR u l-ismijiet assoċjati (50, 150, 200, 300 u 400 mg pilloli b'rilaxx prolongat li fihom quetiapine)
English: 26 August 2010
Maltese: 26 ta' Awwissu 2010
English: It is used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: Jintuża f'pazjenti bi skizofrenija, marda mentali b'għadd ta' sintomi, inkluż ħsibijiet u diskorsi disorganizzati, alluċinazzjonijiet (li wieħed jara jew jisma' affarijiet li mhumiex hemm), li wieħed ikun suspettuż u delużjonijiet (twemminiet foloz).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that Seroquel XR can be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) ikkonkluda li Seroquel XR jista' jintuża bħala kura bla waqfien addizzjonali għal episodji ta' dipressjoni maġġuri f'pazjenti b'disturb dipressiv maġġuri li kellhom rispons sub-ottimali għall-kura b'antidipressanti oħrajn.
English: Seroquel XR is available as prolonged-release tablets.
Maltese: Seroquel XR jiġi bħala pilloli ta' rilaxx prolongat.
English: It is also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Maltese: Jintuża wkoll għall-prevenzjoni u għall-kura ta' disturb bipolari, mard mentali li bih, pazjenti jkollhom episodji manijaċi (perjodi ta' burdata tajba b'mod mhux normali), li jalternaw ma' perjodi ta' burdati normali, kif ukoll episodji ta' depressjoni.
English: The Committee recommended that the medicine be used as add-on to ongoing treatment for major depressive episodes in MDD patients who have had sub-optimal response to monotherapy with another antidepressant.
Maltese: MDD li kellhom rispons sub-ottimali għal monoterapija ma' antidepressant ieħor.
English: The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin.
Maltese: Il-mekkaniżmu ta' azzjoni eżatt ta' quetiapine mhuwiex magħruf, iżda jeħel ma' bosta riċetturi fuq ilwiċċ taċ-ċelloli tan-nevituri fil-moħħ, inkluż mar-riċetturi għan-newrotrasmettituri dopamine u serotonin.
English: Seroquel XR is also marketed under other trade names: Seroquel Depot, Seroquel Prolong, and Seroquel SR.
Maltese: Seroquel XR jiġi kkummerċjalizzat ukoll taħt ismijiet kummerċjali oħrajn: Seroquel Depot, Seroquel Prolong, u Seroquel SR. Il-kumpanija li tpoġġi dawn il-mediċini fis-suq hija Astra Zeneca.
English: The European Medicines Agency has completed an arbitration procedure for Seroquel XR and associated names.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ għal Seroquel XR u l-ismijiet assoċjati.
English: The variation to the marketing authorisation was rejected because the Member States concluded that the benefit-risk balance of the medicine was unfavourable.
Maltese: Il-varjazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq ġiet rifjutata minħabba li l-Istati Membri kkonkludew li l-bilanċ bejn il-benefiċċju-riskju tal-mediċina kien wieħed mhux favorevoli.
English: Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Maltese: Rilaxx prolongat ifisser li s-sustanza attiva tiġi tilaxxata bil-mod mill-pillola tul ammont żgħir ta' sigħat.
English: On 15 May 2009, the Netherlands and all the other concerned Member States rejected a change (variation) to the marketing authorisation to add as a new indication the treatment of recurrent depressive episodes in patients with major depressive disorder (MDD).
Maltese: Fil-15 ta' Mejju 2009, il-Pajjiżi l-Baxxi u l-Istati Membri l-oħrajn kollha kkonċernati rrifjutaw bidla (varjazzjoni) għall-awtorizzazzjoni għat-tqegħid fis-suq biex tiżdied indikazzjoni ġdida, il-kura ta' episodji dipressivi rikorrenti f'pazjenti b'disturb dipressiv maġġuri (MDD). L-indikazzjoni eskludiet l-użu ta' Seroquel XR bħala kura inizjali, u llimitat l-użu tiegħu biss għal pazjenti li ma jistgħux jiġu ġestiti b'mod xieraq fuq kura antidipressanti alternattiva.
English: Treatment difference (SE)
Maltese: Differenza fit trattament (SE)
English: INFECTOPHARM Arzneimittel und Consilium GmbH
Maltese: Arzneimittel und Consilium GmbH
English: p-value*
Maltese: valur p*
English: 4 rue de Marivaux
Maltese: SARL 4 rue de Marivaux
English: 5- or 8-methoxypsoralen
Maltese: 5- jew 8-methoxypsoralen
English: France e-mail: regulatory@neurim.com
Maltese: Franza e-mail: regulatory@neurim.com
English: EU/1/18/1318/001 EU/1/18/1318/002 EU/1/18/1318/003 EU/1/18/1318/004 EU/1/18/1318/005
Maltese: EU/1/18/1318/001 EU/1/18/1318/002 EU/1/18/1318/003 EU/1/18/1318/004
English: Mood swings, Aggression, Irritability
Maltese: Bidliet fil-burdata, Aggressjoni, Irritabbiltà
English: Group Adjusted treatment means (SE) [95% CI]
Maltese: Grupp Trattament aġġustat tfisser (SE) [95 % CI]
English: Slenyto 1.43(0.565)(0.31,2.55) Placebo -0.75(0.608)(-1.95,0.46)
Maltese: Slenyto 1.43(0.565)(0.31,2.55) Plaċebo -0.75(0.608)(-1.95,0.
English: Adjusted treatment means (SE) [95% CI]
Maltese: Trattament aġġustat tfisser (SE) [95 % CI]
English: Slenyto contains lactose monohydrate.
Maltese: Slenyto fih lactose monohydrate.
English: The adjusted estimated treatment differences were 43.2 minutes in the all Randomized Set (MI, p=0 .039).
Maltese: Id-differenzi fit-trattament stmati aġġustati kienu 43.2 minuti fis-Sett Randomized kollu (MI, p=0 .039).
English: Slenyto is available in two strengths: 1 mg and 5 mg.
Maltese: Slenyto huwa disponibbli f'żewġ qawwiet: 1 mg u 5 mg.
English: Terminal half life (t½) is 3.5-4 hours.
Maltese: Il-half life terminali (t½) hija bejn 3 sigħat u nofs u erba' sigħat.
English: • carbamazepine (used in the treatment of epilepsy)
Maltese: • carbamazepine (użata fit-trattament tal-epilessija)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 Settembru 2018
English: • oestrogens (used in contraceptives or hormone replacement therapy)
Maltese: • oestrogens (użati fil-kontraċettivi jew fit-terapija għas-sostituzzjoni tal-ormoni)
English: • Hangover feeling
Maltese: • Sensazzjoni ta' hangover
English: • quinolones (for example ciprofloxacin and norfloxacin) and rifampicin (used in the treatment of bacterial infections)
Maltese: • quinolones (pereżempju ciprofloxacin u norfloxacin) u rifampicin (użati fit-trattment ta'
English: Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo Barcarena
Maltese: Iberfar - Indústria Farmacêutica, S.A. Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo Barcaena
English: • beta-blockers (used to control blood pressure).
Maltese: • beta-blockers (użati għall-kontroll tal-pressjoni tad-demm).
English: 30 months (PVC/PVDC blister) 18 months (HDPE bottle)
Maltese: 30 xhur (folja tal-PVC/PVDC) 18 xhur (flixkun tal-HDPE)
English: There is a significant first pass effect with an estimated first pass metabolism of 85%.
Maltese: Hemm effett sinifikanti tal-ewwel pass (first pass effect) b'metaboliżmu stmat tal-ewwel pass ta' 85 %.
English: 3 years (PVC/PVDC blister and HDPE bottle)
Maltese: 3 snin (folja tal-PVC/PVDC u flixkun tal-HDPE)
English: • Risk Management Plan (RMP)
Maltese: • Pjan TAl-Ġestjoni tar-Riskju (RMP)
English: CARTON AND LABEL (HDPE BOTTLE) - 1 MG
Maltese: KARTUNA U TIKKETTA (FLIXKUN tal-HDPE) - 1 MG
English: • non-steroidal anti-inflammatory medicines such as aspirin and ibuprofen (used for treating pain and inflammation).
Maltese: • Mediċini antinfjammatorji nonsterojdali bħall-aspirina u l-ibuprofen (użati għat-trattament tal-uġigħ u l-infjammazzjoni).
English: Fluvoxamine increases melatonin levels (by 17-fold higher AUC and a 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19.
Maltese: Fluvoxamine żżid il-livelli tal-melatonina (bi 17-il darba aktar AUC u bi 12-il darba aktar serum Cmax) billi tinibixxi l-metaboliżmu tagħha permezz ta' iżoenżimi ta' ċitokromu epatiku P450 (CYP) CYP1A2 and CYP2C19.
English: Bioavailability is in the order of 15%.
Maltese: Il-bijodisponibbiltà hija bejn wieħed u ieħor ta' 15 %.
English: Elimination is by renal excretion of metabolites, 89% as sulfated and glucoronide conjugates of 6-hydroxymelatonin (over 80% as 6-sulfatoxy melatonin) and 2% is excreted as melatonin (unchanged active substance).
Maltese: It-tneħħija sseħħ permezz tal-eliminazzjoni mill-kliewi tal-metaboliti, 89 % bħala konjugati talglukoronida u tas-sulfat ta' 6-hydroxymelatonin (aktar minn 80 % bħala melatonina 6-sulfatoxy) u 2 % jiġi eliminat bħala melatonina (sustanza attiva mingħajr tibdil).
English: Slenyto contains lactose.
Maltese: Slenyto fih lactose.
English: *MMRM analysis CI = confidence interval; WHO-5= the World Health Organization Well-Being Index; CSDI =
Maltese: *MMRM analiżi tas-CI = intervall ta' fiduċja; WHO-5=
English: Pack size: 60 tablets.
Maltese: Daqs tal-pakkett: 60 pillola.
English: At baseline, mean TST was 457.2 minutes in the Slenyto and 459.9 minutes in the placebo group.
Maltese: Bħala linja bażi, it-TST medju kien 457.2 minuti fil-grupp ta' Slenyto u 459.9 minuti fil-grupp tal-plaċebo.
English: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.86 mg lactose.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha lactose monohydrate ekwivalenti għal 8.86 mg ta' lactose.
English: INFORMATION IN BRAILLE Slenyto 1 mg
Maltese: Slenyto 1 mg
English: Puh/Tel: +3589 329 59100 e-mail: info@biocodex.fi
Maltese: +3589 329 59100 e-mail: info@biocodex.fi
English: Clinical efficacy and safety in the paediatric population
Maltese: Effikaċja klinika u sigurtà fil-popolazzjoni pedjatrika
English: Data are available for up to 2 years' treatment.
Maltese: Data hija disponibbli sa trattament ta' sentejn.
English: Pack size: 30 tablets.
Maltese: Daqs tal-pakkett: 30 pillola.
English: The following adverse reactions (frequency unknown) have been reported with off-label use of the adult formulation, 2 mg prolonged-release melatonin tablets: epilepsy, visual impairment, dyspnoea, epistaxis, constipation, decreased appetite, swelling face, skin lesion, feeling abnormal, abnormal behaviour and neutropenia.
Maltese: Ir-reazzjonijiet avversi li ġejjin (frekwenza mhux magħrufa) ġew irrappurtati bl-użu mhux skont ittikketta tal-formulazzjoni tal-adulti, pilloli tal-melatonina li jerħu l-mediċina bil-mod ta' 2 mg: epilessija, indeboliment viżiv, dispnea, epistassi, stitikezza, tnaqqis fl-aptit, nefħa tal-wiċċ, leżjoni filġilda, tħossok mhux sew, imġiba anormali u newtropenija.
English: Concomitant use with fluvoxamine, alcohol, benzodiazepines/non-benzodiazepines hypnotics, thioridazine and imipramine is not recommended (see section 4.5).
Maltese: L-użu konkomitanti ma' fluvoxamine, mal-alkoħol, ma' benzodiazepines/non-benzodiazepines hypnotics, ma' thioridazine u ma' imipramine mhuwiex rakkomandat (ara sezzjoni 4.5).
English: The principal metabolite is 6-sulfatoxy-melatonin (6-S-MT), which is inactive.
Maltese: Il-metabolit prinċipali huwa 6-sulfatoxy-melatonin (6-S-MT), li mhuwiex attiv.
English: • Fits (epilepsy)
Maltese: • Attakki ta' epilessija (epilessija)
English: • benzodiazepines and non-benzodiazepine hypnotics such as zaleplon, zolpidem and zopiclone
Maltese: • benzodiazepines u non-benzodiazepine hypnotics bħal zaleplon, zolpidem u zopiklon (użati biex jikkawżaw l-irqad)
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-klassijiet tal-organi u l-kategoriji tal-frekwenzi tassistema MedDRA.
English: When
Maltese: JIS
English: RAD Neurim Pharmaceuticals EEC SARL
Maltese: RAD Neurim Pharmaceuticals EEC
English: Fidia Farmaceutici S.p.A. Tel: +39 049 8232355 e-mail: info@fidiapharma.it
Maltese: Tel: +39 049 8232355 e-mail: info@fidiapharma.it
English: CSDI satisfaction Slenyto 1.43(0.175)(1.08,1.78) Placebo 0.71(0.184)(0.34,1.07)
Maltese: Slenyto 1.43(0.175)(1.08,1.
English: Tel: +34 91 7711500 e-mail: comunicación@exeltis.com
Maltese: EXELTIS HEALTHCARE, S.L. Tel: +34 91 7711500 e-mail: comunicación@exeltis.com
English: Each prolonged-release tablet contains lactose monohydrate equivalent to 8.32 mg lactose.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha lactose monohydrate ekwivalenti għal 8.32 mg ta' lactose.
English: Total score
Maltese: Punteġġ Totali
English: By the end of the 13-week treatment period, children fell asleep on average 39.6 minutes faster with Slenyto and 12.5 minutes faster with placebo adjusted mean treatment difference -25.3 minutes in the all Randomized Set; MI( p=0.012) without causing earlier wakeup time.
Maltese: Sa tmiem il-perjodu tat-trattament ta' 13-il ġimgħa, it-tfal bħala medja raqdu 39.6 minuta aktar malajr b'Slenyto u 12.5 minuta aktar malajr bil-plaċebo differenza ta' trattament medju aġġustat -25.3 minuti fis-Sett Randomized kollu; MI (p=0.012) mingħajr ma kkawżaw ħin ta' qawmien aktar bikri.
English: The kinetics of melatonin are linear over the range of 2-8 mg.
Maltese: Il-kinetika tal-melatonina hija lineari fuq firxa ta' bejn 2 u 8 mg.
English: The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Maltese: L-assorbiment ta' melatonina oralment inġestita huwa komplut fl-adulti u jista' jitnaqqas b'sa massimu ta' 50 % fl-anzjani.
English: System Organ Class
Maltese: Sistema tal-Klassifikazzjoni tal
English: At baseline, mean Sleep Latency (SL) was 95.2 minutes in the Slenyto and 98.8 minutes in the placebo group.
Maltese: Bħala linja bażi, il-Latenza medja tal-Irqad (SL) kienet 95.2 minuti fil-grupp ta' Slenyto u 98.8 minuti fil-grupp tal-plaċebo.
English: Melatonin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Maltese: Il-melatonina filbiċċa l-kbira hija mwaħħla ma' albumin, alpha1-acid glycoprotein u lipoprotein ta' densità għolja.
English: Table 1: CHILD BEHAVIOUR (13 weeks Double-blind)
Maltese: Tabella 1: IMĠIBA TAT-TFAL (13-il ġimgħa Double-blind)