FrancophonIA/ELRC3.0 huggingface dataset:
English: A large epidemiological study based on data from the Association France-Hypophyse registry was ongoing since 2007 - the French Santé Adulte GH Enfant (SAGHE) study.
Maltese: Studju epidemijoloġiku kbir ibbażat fuq dejta mir-reġistru ta' Association France-Hypophyse ilu għaddej mill-2007 - l-istudju Franċiż Santé Adulte GH Enfant (SAGHE).
English: On 9 December 2010, the French National Competent Authority (AFSSAPS) informed the European Commission, the European Medicines Agency and all Member States of unpublished results of the SAGHE study that showed an all-cause mortality significantly higher in children treated with rhGH (standard mortality ratio - SMR of 1.33, 95% CI 1.08;1.64).
Maltese: Fid-9 ta' Diċembru 2010, l-Awtorità Kompetenti Nazzjonali Franċiża (AFSSAPS) informat lillKummissjoni Ewropea, lill-Aġenzija Ewropea għall-Mediċini u lill-Istati Membri kollha b'riżultati mhux ippubblikati tal-istudju SAGHE li wrew mortalità ta' kull kawża ferm ogħla fi tfal ikkurati b'rhGH (proporzjon ta' mortalità standard - SMR ta' 1.33, 95% CI 1.08;1.64).
English: Annex II
Maltese: Lancet 2002;
English: It is noted that in this group, 225 (80%) patients were part of a company-sponsored study conducted in children born short for gestational age (SGA) and overall this is considered a very small subpopulation for a clear association of the suggested risk with the dose.
Maltese: Huwa nnotat li f'dan ilgrupp, 225 (80%) pazjent kienu parti mill-istudju sponsorjat mill-kumpanija mwettaq fi tfal li twieldu qosra għall-età ġestazzjonali (SGA) u b'mod ġenerali din hija meqjusa bħala subpopolazzjoni żgħira ħafna għal assoċjazzjoni ċara tar-riskju ssuġġerit bid-doża.
English: The suggested increased risk with the higher doses is only statistically significant in the group treated with mean doses above 50 µg/kg/day (n=281).
Maltese: Ir-riskju miżjud suġġerit bl-ogħla dożi huwa biss statistikament sinifikanti fil-grupp ikkurat bid-dożi medji ogħla minn 50 µg/kg/jum (n=281).
English: 2 Sklar CA, Mertens AC, Mitby P, et al. Risk of disease recurrence and second neoplasms in survivors of childhood cancer treated with growth hormone: A report from the Childhood Cancer Survivor Study.
Maltese: Risk of disease recurrence and second neoplasms in survivors of childhood cancer treated with growth hormone:
English: In the Union, somatropin is approved to be used in children for growth hormone deficiency (including idiopathic growth hormone deficiency), growth failure in patients with Turner syndrome, chronic renal insufficiency or short stature homebox-containing gene (SHOX) deficiency, PraderWilli syndrome and in patients born small for gestational age (SGA).
Maltese: Fl-Unjoni, somatropin huwa approvat sabiex jintuża fi tfal għal nuqqas ta' ormon tat-tkabbir (inkluż nuqqas ta' ormon tat-tkabbir idjopatiku), nuqqas ta' tkabbir f'pazjenti bis-sindromu ta' Turner, indeboliment renali kroniku jew nuqqas ta' ġene li fih homebox ta' statura qasira (SHOX), is-sindromu ta' Prader-Willi u f'pazjenti li twieldu żgħar għal età ġestazzjonali (SGA).
English: The SAGHE study in Europe is part of the FP7 Health work programme and approximatelly the sample size is of 30,000 patients will be included in the 8 involved countries (France, Belgium, United Kingdom, Netherlands, Switzerland, Italy, Germany and Sweden).
Maltese: L-istudju SAGHE fl-Ewropa huwa parti mill-programm ta' ħidma tas-Saħħa FP7 u kampjun ta' bejn wieħed u ieħor id-daqs ta' 30,000 pazjent sejjer jiġi inkluż fi 8 pajjiżi involuti (Franza, il-Belġju, ir-Renju Unit, il-Pajjiżi l-Baxxi, lIsvizzera, l-Italja, il-Ġermanja u l-Isvezja).
English: Furthermore, the Committee agreed to emphasise in the Product Information (section 4.4) the need for the maximum recommended dose not to be exceeded.
Maltese: il-Kumitat qabel li jenfasizza fl-Informazzjoni tal-Prodott (sezzjoni 4.4), il-ħtieġa li d-doża massima rakkomandata ma tinqabiżx.
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended for somatropin-containing medicinal products;
Maltese: • Il-Kumitat qies li l-proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata għal prodotti mediċinali li fihom somatropin.
English: • The Committee agreed that the French SAGHE study has significant methodological limitations (e.g. general population used as reference for the calculation of mortality).
Maltese: • Il-Kumitat qabel li l-istudju Franċiż SAGHE kellu limitazzjonijiet metodoloġiċi sinifikanti (eż. popolazzjoni ġenerali użata bħala referenza għall-kalkolu tal-mortalità).
English: All 10,330 patients were assigned to three risk categories for long-term mortality based on the clinical condition.
Maltese: L-10,330 pazjent kollha ġew assenjati lil tliet kategoriji ta' riskji għal mortalità fit-tul fuq il-bażi talkundizzjoni klinika.
English: No information on the presence of cardiovascular risk factors was available for 3 out of 9 patients.
Maltese: Ebda informazzjoni dwar il-preżenza ta' fatturi ta' riskji kardjovaskulari ma kienet disponibbli għal 3 minn 9 pazjenti.
English: Some indications are not approved for all somatropin containing medicines.
Maltese: Xi indikazzjonijiet mhumiex approvati għall-mediċini kollha li fihom somatropin.
English: The CHMP reviewed all data submitted including data from the French SAGHE study and from clinical trials, registries, cohorts and safety databases (pharmacovigilance) as well as data available in the literature relating to the cardiovascular risk and risk of neoplasm associated with somatropin-treatment.
Maltese: Is-CHMP irreveda d-dejta kollha sottomessa inkluż dejta mill-istudju tas-SAGHE Franċiż u mill-provi kliniċi, reġistri, koorti u databases tas-sikurezza (farmakoviġilanza) kif ukoll dejta disponibbli firriċensjoni relatata mar-riskju kardjovaskulari u r-riskju ta' neoplasma assoċjat ma' kura b'somatropin.
English: Results of the French SAGHE study, a long-term surveillance study in a high number of patients and with a mean follow up of 17 years suggested an overall increase of mortality in patients treated with somatropin for isolated growth hormone deficiency (GDH), idiopathic short stature (ISS) and short for gestational age (SGA) compared to the general population.
Maltese: Riżultati mill-istudju Franċiż SAGHE, studju ta' sorveljanza fit-tul f'numru kbir ta' pazjenti u b'segwitu medju ta' 17-il sena ssuġġerixxa żieda ġenerali fil-mortalità f'pazjenti kkurati b'somatropin għal nuqqas ta' ormon tat-tkabbir iżolat (GDH), statura qasira idjopatika (ISS) u tul qasir għall-età ġestazzjonali (SGA) meta mqabbel mal-popolazzjoni ġenerali.
English: This information is very limited not allowing a conclusion with regards the cardiovascular risks.
Maltese: Din l-informazzjoni hija limitata ħafna u ma tippermettix li tinġibed konklużjoni fir-rigward tar-riskji kardjovaskulari.
English: Therefore, limited information on long-term safety of somatropin treatment is currently available.
Maltese: Għaldaqstant, fil-preżent hemm informazzjoni limitata disponibbli dwar is-sikurezza fit-tul ta' kura b'somatropin.
English: Overall summary of the scientific evaluation of somatropin-containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom somatropin (ara Anness I)
English: Considering previously published data and information already included in the Product Information for some somatropins, the Committee considered that it is justified to harmonise existing contraindications for all somatropin containing medicines when there is any evidence of activity of a tumour.
Maltese: Meta wieħed iqis dejta ppubblikata preċedentament u informazzjoni inkluża diġà flInformazzjoni tal-Prodott għal xi somatropins, il-Kumitat qies li jkun iġġustifikat li kontraindikazzjonijiet eżistenti jiġu armonizzati għall-mediċini kollha li fihom somatropin meta jkun hemm xi evidenza ta' attività ta' tumur.
English: Of the 93 allcause mortality cases, 21 classified as resulting from “ill-defined conditions” are of unknown cause.
Maltese: Mit-93 każ ta' mortalità ta' kull kawża, 21 ikklassifikati bħala li jirriżultaw minn “kundizzjonijiet definiti ħażin” huma ta' kawża mhux magħrufa.
English: Secondly, due to several published studies that reported a higher risk of tumour and/or tumour related mortality for patients treated with growth hormone (Swerdlow et al. 20021, Sklar et al. 20022 and by Ergun-Longmire et al. 20063).
Maltese: L-ewwel nett, minħabba l-plawsibilità bijoloġika bbażata fuq il-potenzjal tumuriġeniku stabbilit ta' fattur tat-tkabbir simili għallinsulina-1 (IGF-1), li huwa l-medjatur ewlieni ta' attività GH u li huwa mnixxi b'rispons għal attivazzjoni ta' riċettur GH. It-tieni nett, minħabba bosta studji ppubblikati li rrapportaw riskju ogħla ta' tumur u/jew mortalità relatata mat-tumuri għal pazjenti kkurati b'ormon tat-tkabbir (Swerdlow et al. 20021, Sklar et al. 20022 u minn Ergun-Longmire et al. 20063).
English: The specific wording to be include in section 4.3 of the SmPCs and reflected in the package leaflets of all somatropin-containing medicinal products was agreed (see Annex II).
Maltese: Sar qbil dwar il-formulazzjoni tal-kliem speċifika li għandha tiġi inkluża fis-sezzjoni 4.3 tal-SmPCs u li hija riflessa fil-fuljetti ta' tagħrif tal-prodotti mediċinali kollha li fihom somatropin (ara Anness II).
English: Also, the characteristics of the treated patients that per se may be associated with increased mortality, even if in a low risk group (i.e. treated for isolated GHD, ISS and SGA).
Maltese: Barra minn hekk, il-karatteristiċi tal-pazjenti kkurati li per se jistgħu jkunu assoċjati ma' żieda filmortalità, anki jekk fi grupp ta' riskju baxx (jiġifieri ikkurati għal GHD, ISS u SGA iżolati).
English: Somatropin-treatment has been associated with tumour-promoting potential and this is currently reflected in the product information of all somatropin-containing medicinal products.
Maltese: Il-kura b'somatropin kienet assoċjata mal-potenzjal ta' promozzjoni ta' tumur u fil-preżent hija riflessa fl-informazzjoni tal-prodott, tal-prodotti mediċinali kollha li fihom somatropin.
English: - Agitation, aggression and psychotic symptoms associated with dementia
Maltese: - Aġitazzjoni, aggressjoni u sintomi psikotiċi assoċjati mad-demenzja.
English: Grounds for the CHMP opinion Whereas
Maltese: Raġunijiet għall-opinjoni tas-CHMP Billi
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC for Haldol and associated names;
Maltese: • Il-Kumitat ikkunsidra r-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE għal Haldol u l-ismijiet assoċjati.
English: As CYP3A4 and, to a lesser extent, CYP2D6 are involved in the metabolism of haloperidol, the potential increase in haloperidol plasma concentrations when a CYP3A4 and/or CYP2D6 inhibitor is coadministered may range between 20 to 40%, although in some cases, increases of up to 100% have been reported, and has been added in section 4.5 Interaction with other medicinal products and other forms of interaction.
Maltese: Billi CYP3A4 u, sa ċertu punt inqas, CYP2D6 huma involuti fil-metaboliżmu ta' haloperidol, iż-żieda potenzjali fil-konċentrazzjonijiet ta' plażma fil-haloperidol meta jiġi koamministrat inibitur ta' CYP3A4 u/jew CYP2D6 tista' tvarja bejn 20 sa 40%, għalkemm f'xi każijiet, ġew irrapportati żidiet sa massimu ta' 100% u din żdiedet fis-sezzjoni 4.5
English: Section 4.3 was also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Maltese: Is-sezzjoni 4.3 ġiet emendata wkoll sabiex tinkludi l-formulazzjoni relatata mal-kontraindikazzjoni ta' riskju kardjotossiku tal-haloperidol.
English: It is a potent central dopamine type 2 receptor antagonist, and at recommended dosages, has no antihistaminergic or anticholinergic activity and minimal alpha 1 adrenergic activity.
Maltese: Huwa antagonista ċentrali potenti ta' riċettur dopaminerġiku tat-tip 2 u, f'dożi rakkomandati, ma għandu ebda attività antistaminerġika jew antikolinerġika, filwaqt li għandu attività adrenerġika minima ta' alfa 1.
English: Scientific conclusions Haldol, which contains the active substance haloperidol, is an antipsychotic belonging to the butyrophenone group.
Maltese: Haldol, li fih is-sustanza attiva haloperidol, huwa antipsikotiku li jappartjeni għall-grupp butyrophenone.
English: Haldol has been approved nationally in the European Union (EU) with many differences in the wording of the summary of product characteristics (SmPC), in the various Member States.
Maltese: Haldol Decanoate kien approvat fuq livell nazzjonali fl-Unjoni Ewropea (UE) b'ħafna differenzi filformulazzjoni tas-sommarju tal-karatteristiċi tal-prodott (SmPC), fid-diversi Stati Membri.
English: - Treatment of schizophrenia in paediatric population
Maltese: - Il-kura ta' skiżofrenija fil-popolazzjoni pedjatrika
English: - Treatment of acute alcohol intoxication
Maltese: - Il-kura ta' intossikazzjoni akuta bl-alkoħol
English: For the injectable formulations: - Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
Maltese: - Il-kontroll rapidu ta' aġitazzjoni psikomotorja akuta gravi assoċjata ma' disturb psikotiku jew episodji ta' manija ta' disturb bipolari I meta t-terapija orali ma tkunx addattata.
English: Section 4.6 has been harmonised and the information presented under the separate subheadings of Pregnancy, Lactation and Fertility in compliance with the SmPC guideline.
Maltese: Is-sezzjoni 4.6 ġiet armonizzata u l-informazzjoni ppreżentata taħt is-subintestaturi separati ta' Tqala, Treddigħ u Fertilità f'konformità mal-linja gwida tal-SmPC.
English: - Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.
Maltese: - Skiżofrenija f'adoloxxenti fl-età ta' bejn 13 u 17-il sena meta kwalunkwe kura farmakoloġika oħra tkun falliet jew ma tkunx ittollerata.
English: - Tic disorders including Tourette's syndrome
Maltese: - Disturbi li jinvolvu tgħawwiġ involontarju tal-muskoli, l-aktar tal-wiċċ, inkluża s-sindrome ta' Tourette
English: - Tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.
Maltese: - Disturbi li jinvolvu tgħawwiġ involontarju tal-muskoli, l-aktar tal-wiċċ, inkluża s-sindrome Tourette, fi tfal u adoloxxenti fl-età ta' bejn 10 snin u 17-il sena b'indeboliment sever wara li tkun falliet il-kura edukattiva, psikoloġika u kwalunkwe kura farmakoloġika oħra.
English: Paediatric indications were agreed only for the oral formulations for the treatment of:
Maltese: Għall-formulazzjonijiet orali:
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Maltese: Il-bidliet fl-SmPC, meta rilevanti għallutent, kienu riflessi wkoll fil-PL u approvati mis-CHMP.
English: The questions to the HCPOs mainly pertained to the clinical value of the indications (section 4.1) and dosing recommendations in clinical practice (section 4.2), as well as the contraindication for haloperidol due to central nervous system depression, and whether it was possible to define the severity/degree of central nervous system depression due to alcohol or other depressant medicinal products, and whether there specific cases where the use of haloperidol should be contraindicated.
Maltese: Il-mistoqsijiet lill-HCPOs primarjament kellhom x'jaqsmu mal-valur kliniku tal-indikazzjonijiet (sezzjoni 4.1) u mar-rakkomandazzjonijiet ta' dożaġġ fil-prattika klinika (sezzjoni 4.2), kif ukoll mal-kontraindikazzjoni għal haloperidol minħabba dipressjoni fis-sistema nervuża ċentrali u jekk kienx possibbli li jiġu definiti s-severità/il-grad tad-dipressjoni fis-sistema nervuża ċentrali minħabba l-alkoħol jew prodotti mediċinali dipressanti oħrajn u jekk hemmx każijiet speċifiċi fejn lużu ta' haloperidol għandu jiġi kontraindikat.
English: - Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.
Maltese: - Il-kura ta' sintomi psikotiċi u ta' aggressjoni persistenti f'pazjenti b'demenzja ta' Alzheimer moderata sa severa meta tkun falliet il-kura farmakoloġika u meta jkun hemm riskju ta' ħsara għall-pazjent jew għal oħrajn.
English: Furthermore, observational studies have consistently reported an increased mortality in elderly haloperidol users - the highest mortality risk with haloperidol was in the first 30 days and persists for at least 6 months.
Maltese: Barra minn hekk, l-istudji ta' osservazzjoni rrapportaw b'mod konsistenti żieda filmortalità ta' anzjani li jagħmlu użu minn haloperidol - l-ogħla riskju ta' mortalità b'haloperidol kien fl-ewwel 30 jum u jippersisti għal mill-inqas 6 xhur.
English: The SAG Psychiatry was consulted on the clinical value of the following adult and paediatric indications (section 4.1) and also on dosing recommendations in clinical practice (section 4.2):
Maltese: L-SAG fil-Psikjatrija ġie kkonsultat dwar il-valur kliniku tal-indikazzjonijiet adulti u pedjatriċi li ġejjin (sezzjoni 4.1), kif ukoll dwar irrakkomandazzjonijiet ta' dożaġġ fil-prattika klinika (sezzjoni 4.2):
English: The information under the subheading extrapyramidal symptoms was further elaborated to include the symptoms and time to onset of acute dystonia and akathisia.
Maltese: L-informazzjoni taħt is-subintestatura sintomi ekstrapiramidali ġiet elaborata aktar sabiex tinkludi s-sintomi u ż-żmien għal bidu ta' distonja akuta u akatiżja.
English: Overall summary of the scientific evaluation by the CHMP Based on the review of all available data, the consultations with the Healthcare Professionals Organisations (HCPOs) and Scientific Advisory Group (SAG) Psychiatry, the CHMP recommended the following revisions to harmonise the product information for Haldol oral and injectable formulations.
Maltese: Abbażi tar-rieżami tad-data kollha disponibbli, il-konsultazzjonijiet mal-Organizzazzjonijiet ta' Professjonisti fil-Qasam tal-Kura tas-Saħħa (HCPOs) u mal-Grupp Konsultattiv Xjentifiku (SAG) filPsikjatrija, is-CHMP irrakkomanda r-reviżjonijiet li ġejjin għall-armonizzazzjoni tal-informazzjoni dwar il-prodott għall-formulazzjonijiet orali u injettabbli ta' Haldol.
English: As regards the posology, section 4.2 of the SmPC, the initial and maximum doses were clarified and listed for each indication, for all patient populations - adult, elderly and paediatric.
Maltese: Fir-rigward tal-pożoloġija, is-sezzjoni 4.2 tal-SmPC, id-dożi inizjali u massimi ġew iċċarati u elenkati għal kull indikazzjoni, għall-popolazzjonijiet tal-pazjenti kollha - adulti, anzjani u pedjatriċi.
English: - Treatment of moderate to severe manic episodes associated with bipolar I disorder.
Maltese: - Il-kura ta' episodji moderati sa severi ta' manija assoċjati ma' disturb bipolari I.
English: - Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.
Maltese: - Il-kura ta' aġitazzjoni psikomotorja akuta assoċjata ma' disturb psikotiku jew episodji ta' manija ta' disturb bipolari I.
English: - Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated.
Maltese: - Il-kura ta' korea ħafifa sa moderata fil-marda ta' Huntington, meta prodotti mediċinali oħrajn ikunu ineffettivi jew mhux ittollerati.
English: - Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated.
Maltese: - Profilassi unika jew f'kombinazzjoni f'pazjenti f'riskju moderat sa għoli ta' dardir u remettar wara operazzjoni, meta prodotti mediċinali oħrajn ikunu ineffettivi jew mhux ittollerati.
English: • The Committee agreed on a harmonised product information for Haldol and associated names.
Maltese: • Il-kumitat qabel ma' informazzjoni dwar il-prodott armonizzata għal Haldol u l-ismijiet assoċjati.
English: Angioedema was added to section 4.8 Undesirable effects and additional information on the site of action of injectable haloperidol in the treatment and prophylaxis of nausea and vomiting has been included in section 5.1 Pharmacodynamic properties.
Maltese: L-anġjoedema żdiedet fis-sezzjoni 4.8 Effetti mhux mixtieqa u informazzjoni addizzjonali dwar is-sit ta' azzjoni ta' haloperidol injettabbli fil-kura u l-profilassi tad-dardir u r-remettar ġiet inkluża fissezzjoni 5
English: In section 5.2 Pharmacokinetic properties, a statement that back-conversion to haloperidol cannot be fully excluded has been included although it is not possible to quantitate the role of back-oxidation of reduced haloperidol to haloperidol on haloperidol half-life, clearance and activity.
Maltese: .2 Proprjetajiet farmakokinetiċi ġiet inkluża dikjarazzjoni li l-konverżjoni lura għal haloperidol ma tistax tiġi eskluża għal kollox, għalkemm mhuwiex possibbli li jiġi kwantifikat ir-rwol tal-ossidazzjoni lura ta' haloperidol imnaqqsa għal nofs ħajja, ikklirjar u attività ta' haloperidol fuq haloperidol.
English: In patients with hepatic impairment, it is recommended to halve the initial dose, since haloperidol is extensively metabolised in the liver.
Maltese: F'pazjenti b'indeboliment epatiku, huwa rrakkomandat li d-doża inizjali titnaqqas bin-nofs, minħabba li l-haloperidol tiġi metabolizzata b'mod estensiv fil-fwied.
English: - Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.
Maltese: - Il-kura ta' korea ħafifa sa moderata fil-marda ta' Huntington, meta prodotti mediċinali oħrajn ikunu ineffettivi jew mhux ittollerati u meta t-terapija orali ma tkunx addattata.
English: The list of examples of contraindicated combinations considered essential for the prescriber to be informed of the risk of an additive QT prolonging effect of two or more QT prolonging antipsychotics, was moved to section 4.4.
Maltese: Il-lista ta' eżempji ta' kombinazzjonijiet kontraindikati, meqjusa bħala essenzjali sabiex il-preskrittur jiġi informat dwar ir-riskju ta' effett fit-tul ta' QT addittiv ta' żewġ antipsikotiċi fit-tul jew aktar ta' QT, ġiet imċaqilqa għas-sezzjoni 4.4.
English: - Treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.
Maltese: - Il-kura ta' disturbi li jinvolvu tgħawwiġ involontarju tal-muskoli, l-aktar tal-wiċċ, inkluża ssindrome Tourette, f'pazjenti b'indeboliment sever wara li tkun falliet il-kura edukattiva, psikoloġika u kwalunkwe kura farmakoloġika oħra.
English: - Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated.
Maltese: - Aggressjoni severa u persistenti fi tfal u adoloxxenti fl-età ta' bejn 6 snin u 17-il sena b'awtiżmu jew disturbi mifruxa tal-iżvilupp meta kwalunkwe kura farmakoloġika oħra tkun falliet jew ma tkunx ittollerata.
English: - Acute treatment of delirium when non-pharmacological treatments have failed.
Maltese: - Il-kura akuta ta' delirju meta tkun falliet il--kura mhux farmakoloġika.
English: It was agreed that the maximum dose in elderly patients should be 5 mg/day, while higher doses should only be considered in patients who have tolerated higher doses and after reassessment of the patient's individual benefit-risk profile.
Maltese: Kien maqbul li d-doża massima f'pazjenti anzjani għandha tkun ta' 5 mg/jum, filwaqt li dożi ogħla għandhom jiġu kkunsidrati biss f'pazjenti li jkunu ttolleraw dożi ogħla u wara rivalutazzjoni talprofil individwali ta' benefiċċju u riskju tal-pazjent.
English: Pharmaceutical Form Route of Administration Packaging
Maltese: Qawwa Għamla farmaċewtika
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: <Numru tal-proċedura ta' l-EMA> <Numru ta' l-EU>
English: Immediate Packaging
Maltese: Mnejn jingħata Il-pakkett Daqs talpakkett