FrancophonIA/ELRC3.0 huggingface dataset:
English: Anticholinergics: concomitant use of anticholinergics may increase the risk of anticholinergic side effects.
Maltese: Antikolinerġiċi: l-użu konkomitanti ta' antikolinerġiċi jista' jżid ir-riskju ta' effetti sekondarji antikolinerġiċi.
English: In most paediatric subjects, plasma glycopyrronium vs. time plots are reported to show a triexponential curve; adults generally show a biexponential curve.
Maltese: ħin huma rrapportati li juru kurva tri-esponenzjali; l-adulti ġeneralment urew kurva bi-esponenzjali.
English: At least a 3-point improvement in mTDS
Maltese: Mill-anqas titjib ta' 3 punti flmTDS
English: • constipation
Maltese: • Aġitazzjoni
English: Sensitivity, shyness, and social withdrawal disorder specific to childhood or adolescence
Maltese: Sensittività, mistħija, u disturb ta' iżolament soċjali speċifiċi għat-tfulija jew l-adolexxenza
English: Sialanar is not recommended in children below the age of 3 years since there is very limited data on the efficacy and safety of glycopyrronium in this age group.
Maltese: Sialanar mhuwiex rakkomandat fi tfal taħt l-età ta' 3 snin minħabba li hemm data limitata ħafna dwar l-effikaċja u s-sigurtà ta' glikopirronju f'dan il-grupp tal-età.
English: A reduction in anticholinergic and/or tricyclic antidepressants and MAOIs dosage may be necessary.
Maltese: Jista' jkun hemm bżonn ta' tnaqqis fid-doża antikolinerġika u/jew ta' antidepressanti triċikliċi u MAOIs.
English: • Swelling mainly of the tongue, lips, face or throat (possible signs of angioedema) - frequency not known
Maltese: • Nefħa l-aktar tal-ilsien, xufftejn, wiċċ jew griżmejn (sinjali possibbli ta' anġjoedema)frekwenza mhux magħrufa
English: As such Sialanar should not be used in patients over the age of 65 years.
Maltese: Għaldaqstant Sialanar m'għandux jintuża f'pazjenti li għandhom aktar minn 65 sena.
English: The safety and efficacy of glycopyrronium have been studied in an open labelled study with no control group over a 24-week period in children aged 3 to 18 years.
Maltese: Is-sigurtà u l-effikaċja ta' glikopirronju ġew studjati fi studju bit-tikketta mikxufa bl-ebda grupp ta' kontroll fuq perjodu ta' 24 ġimgħa fi tfal li għandhom minn 3 sa 18-il sena.
English: Glycopyrronium can cause thickening of secretions, which may increase the risk of respiratory infection and pneumonia.
Maltese: Glikopirronju jista' jikkawża l-ħxuna tas-sekrezzjonijiet, li jistgħu jikkawżaw żieda fir-riskju ta' infezzjoni respiratorja u pulmonite.
English: The most common anticholinergic adverse reactions in the placebo-controlled studies (see section 5.1) related to the gastrointestinal system and were dry mouth, constipation, diarrhoea and vomiting, all of which occurred at a rate of ≥15%.
Maltese: relatati mas-sistema gastrointestinali kienu ħalq xott, stitikezza, dijarea u rimettar, fejn kollha seħħew b'rata ta' ≥15%.
English: Glycopyrronium is contraindicated in patients with severe renal impairment.
Maltese: L-għoti flimkien mal-ikel jirriżulta fi tnaqqis evidenti fl-esponiment sistemiku tal-prodott mediċinali.
English: • severe allergic reaction (angioedema); signs include swelling mainly of the tongue, lips, face or throat
Maltese: • rezzjoni allerġika severa (anġjoedema); sinjali jinkludu nefħa l-aktar tal-ilsien, xufftejn, wiċċ jew griżmejn
English: Urinary tract infection
Maltese: IL-PRODOTT MEDIĊINALI
English: Due to the lack of long term safety data, Sialanar is recommended for short -term intermittent use (see section 4.4)
Maltese: Minħabba n-nuqqas ta' data dwar is-sigurtà fit-tul, Sialanar huwa rrakkomandat għall-użu intermittenti għal żmien qasir (ara sezzjoni 4.4).
English: EMA/445120/2019 EMEA/H/C/001208
Maltese: EMA/445120/2019 EMA/H/C/001208
English: Further information can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/foclivia.
Maltese: ema.europa.eu/Find medicine/Human medicines/foclivia.
English: Other information about Foclivia
Maltese: Informazzjoni oħra dwar Foclivia
English: Foclivia received a marketing authorisation valid throughout the EU on 19 October 2009.
Maltese: Foclivia rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Ottubru 2009.
English: Twenty-one days after the second injection, 86% of the people receiving the vaccine with 7.5 micrograms haemagglutinin had levels of antibodies that would protect them against H5N1.
Maltese: Wieħed u għoxrin jum wara t-tieni injezzjoni, 86% tan-nies li ngħataw il-vaċċin b'7.5 mikrogrammi ta' emagglutinin kellhom livelli ta' antikorpi li jipproteġuhom kontra H5N1.
English: It contains a flu strain called A/Vietnam/1194/2004 (H5N1).
Maltese: Fih ir-razza tal-influwenza msejħa A/Vietnam/1194/2004
English: The figure was 85% in people who received the 15-microgram dose.
Maltese: Iċ-ċifra kienet 85% fil-persuni li ngħataw iddoża ta' 15-il mikrogramma.
English: The participants received two injections of Foclivia, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Maltese: Il-parteċipanti ngħataw żewġ injezzjonijiet ta' Foclivia, li kien fihom 7.5 jew 15-il mikrogramma ta' emagglutinin (proteina li tinsab fil-virusijiet tal-influwenza), b'21 jum bejn injezzjoni u oħra.
English: The most common side effects with Foclivia (which may affect up to 1 people in 10) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, feeling unwell, tiredness and shivering.
Maltese: L-effetti sekondarji l-aktar komuni b'Foclivia (li jistgħu jaffettwaw sa 1 minn kull 10) huma uġigħ ta' ras, ħruġ ta' għaraq, artralġja (uġigħ fil-ġogi), mijalġja (uġigħ fil-muskoli), reazzjonijiet fis-sit talinjezzjoni (ħmura, nefħa, ebusija, tbenġil, uġigħ), deni, ma tħossokx tajjeb, eżawriment u tertir ta' bard.
English: Foclivia is a ‘pandemic preparedness' vaccine.
Maltese: Foclivia (vaċċin għall-influwenza pandemika
English: Foclivia should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as egg, chicken protein, kanamycin or neomycin (antibiotics), formaldehyde and cetyltrimethylammonium bromide (CTAB).
Maltese: Foclivia ma għandux jingħata lil persuni li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi filvaċċin, bħal bajd, proteini tat-tiġieġ, kanamiċina jew neomiċina (antibijotiċi), formaldeid u bromur taċċetiltrimetilammonju (CTAB).
English: The authorisation was based on the authorisation granted to Focetria in 2007 (‘informed consent').
Maltese: Din lawtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Focetria fl-2007 ("kunsens infurmat”).
English: What information is still awaited for Foclivia?
Maltese: Liema informazzjoni għadha mistennija għal Foclivia?
English: What are the risks associated with Foclivia?
Maltese: X'inhuma r-riskji assoċjati ma' Foclivia?
English: Foclivia has been authorised under ‘exceptional circumstances'.
Maltese: Foclivia ġie awtorizzat taħt “ċirkostanzi ta' eċċezzjoni”.
English: The main study of Foclivia included 486 healthy people (a third of whom were over the age of 60) and compared the ability of two doses of Foclivia to trigger the production of antibodies (immunogenicity).
Maltese: L-istudju ewlieni ta' Foclivia inkluda 486 persuna f'saħħithom (terz minnhom kellhom aktar minn 60 sena) u qabbel l-abbiltà ta' żewġ dożi ta' Foclivia fit-tqanqil tal-produzzjoni ta' antikorpi (immunoġeniċità).
English: As for all medicines, data on the use of Foclivia are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Foclivia hija ssorveljata kontinwament.
English: Foclivia is a vaccine used in adults to protect against flu when a ‘pandemic' has been officially declared by the World Health Organization (WHO) or the European Union (EU).
Maltese: Foclivia huwa vaċċin li jintuża f'adulti sabiex jilqa' kontra l-influwenza meta tiġi ddikjarata uffiċjalment influwenza “pandemika” mill-Organizzazzjoni Dinjija tas-Saħħa (WHO) jew mill-Unjoni Ewropea (UE).
English: Foclivia contains some parts the H5N1 virus.The virus has been first inactivated so that it does not cause disease.
Maltese: Foclivia fih xi partijiet mill-virus H5N1.
English: The study showed that Foclivia produced an antibody response that satisfies these criteria.
Maltese: L-istudju wera li Foclivia pproduċa reazzjoni ta' antikorpi li tissodisfa dawn il-kriterji.
English: According to EMA's criteria, a pandemic preparedness vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Maltese: Skont il-kriterji tal-EMA, vaċċin ta' tħejjija għal pandemija jeħtieġ li joħloq livelli ta' protezzjoni ta' antikorpi f'mhux inqas minn 70% tan-nies biex jitqies adatt.
English: Foclivia contains some parts of inactivated (killed) influenza (flu) virus.
Maltese: Foclivia fih xi partijiet tal-virus inattivat (maqtul) tal-influwenza.
English: Since Foclivia has been authorised under exceptional circumstances, the company that markets Foclivia will collect information on the safety and effectiveness of the final pandemic vaccine when it includes the flu strain responsible for a pandemic in the vaccine.
Maltese: Minħabba li Foclivia ġie awtorizzat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed Foclivia fissuq se tiġbor informazzjoni dwar is-sikurezza u l-effettività tal-vaċċin pandemiku finali meta din tinkludi r-razza tal-influwenza responsabbli għal pandemija fil-vaċċin.
English: When the person comes into contact with this or a similar virus, these antibodies, together with other components of the immune system, will be able to kill the viruses and help protect against the disease.
Maltese: Meta l-persuna tiġi esposta għal dan il-virus jew għal virus simili, dawn l-antikorpi, flimkien ma' komponenti oħra tas-sistema immuni, ikunu kapaċi joqtlu l-virusijiet u jgħinu biex jipproteġu kontra l-marda.
English: Side effects reported with Foclivia are carefully evaluated and any necessary action taken to protect people who receive Foclivia.
Maltese: L-effetti sekondarji rrappurtati b'Foclivia huma evalwati bir-reqqa u kull azzjoni meħtieġa hija meħuda biex tipproteġi lill-pazjenti li jirċievu Foclivia.
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 22), and 21 days later (day 43).
Maltese: Il-kejl ewlieni tal-effikaċja kienu l-livelli ta' antikorpi kontra l-virus tal-influwenza fid-demm qabel il-vaċċinazzjoni, fil-jum tat-tieni injezzjoni (jum 22), u 21 jum aktar tard (jum 43).
English: During a pandemic, the virus strain in Foclivia will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Maltese: Matul pandemija, ir-razza tal-virus f'Foclivia jkollha tinbidel bir-razza li tkun qiegħda tikkaġuna l-pandemija qabel ma l-vaċċin ikun jista' jintuża.
English: For the full list of all side effects of Foclivia, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha ta' Foclivia, ara l-fuljett ta' tagħrif.
English: How is Foclivia used?
Maltese: Kif jintuża Foclivia?
English: What measures are being taken to ensure the safe and effective use of Foclivia?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat użu sigur u effettiv ta' Foclivia?
English: A flu pandemic occurs when a new type (strain) of flu virus can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Maltese: Influwenza pandemika sseħħ meta tip ġdid (razza) tal-virus tal-influwenza jkun jista' jinfirex faċilment minn persuna għal oħra minħabba li n-nies ma jkollhom l-ebda immunità (protezzjoni) kontra tiegħu.
English: Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi jippreparaw lis-sistema immunitarja (id-difiżi naturali tal-ġisem) biex tiddefendi ruħha kontra marda.
English: Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*: A/California/7/2009 (H1N1)v 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin.
Maltese: A/California/07/2009 (H1N1)v 7.5 mikrogrammi** għal kull doża ta' 0.5 ml * propagati f'ċelluli Vero (razza ta' ċelluli kontinwi ta' oriġini mammaljana) ** espressi f'mikrogrammi emaglutinin t x
English: Celvapan microgram /0.5 ml1
Maltese: 7.5 mikrogrammi/ 0.5 ml
English: l t o r
Maltese: Numru ta' l-EU
English: Intramuscular use vial (glass) 0.5 ml
Maltese: Jingħata ġol-muskolu kunjett (ħġieġ)
English: Benefit/risk
Maltese: Benefiċċju/riskju
English: Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edifício 72º e 3º Porto Salvo
Maltese: Produtos Farmacêuticos, S.A. PRT Empreendimento Lagoas Park - Edificio 7 - 2° e 3° Porto Salvo
English: Sanofi-Aventis France 1-13 Boulevard Anatole France 75014 Paris
Maltese: Sanofi-Aventis France 1-13 Boulevard Anatole France 75014
English: Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c, B-1831 Diegem
Maltese: Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c
English: The 27-year post-marketing period offers a long period of safety profile surveillance.
Maltese: Il-perijodu ta' wara t-tqegħid fis-suq ta' 27 sena joffri perijodu twil ta' sorveljanza tal-profil ta' sigurtà.
English: Until June 2005, veralipride was authorised in Spain.
Maltese: Sa Ġunju 2005, veralipride kienet awtorizzata fi Spanja.
English: Spain therefore withdrew veralipride's marketing authorisation on 27 June 2005.
Maltese: Għaldaqstant, Spanja irtirat lawtorizzazzjoni tat-tqegħid fis-suq ta' veralipride fis-27 ta' Ġunju 2005.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing veralipride
Maltese: • Il-Kumitat ikkunsidra r-referenza magħmula taħt l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għal prodotti mediċinali li fihom veralipride;
English: It was first authorised in 1979 and is currently authorised in the EU in Belgium, France, Italy, Luxembourg and Portugal under the names Agreal and Agradil.
Maltese: Ġiet approvata għall-ewwel darba fl-1979 u bħalissa hija awtorizzata fl-UE fil-Belġju, Franza, l-Italja, il-Lussemburgu u l-Portugall taħt l-ismijiet Agreal u Agradil.
English: -Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
Maltese: -Rakkomandazzjonijiet ta' monitoraġġ mediku tas-sider u skeda intermittenti (20 jum segwiti minn perijodu ta' 10 ijiem mingħajr trattament) biex inaqqsu r-riskju ta' iperprolaktinimja, immirati biex itejbu s-sigurtà tas-sider (madankollu, mhux magħruf jekk din il-miżura għandhiex xi effett fuq ilforma ta' episodju avvers osservat relatat ma' l-iperprolaktinimja bħal tkabbir tas-sider, galaktorreja u riskju għal pazjenti b'tumuri dipendenti fuq il-prolaktin bħal ma huma prolaktinoma tal-glandola pitwitarja u kanċer tas-sider).
English: -Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
Maltese: -Introduzzjoni ta' twissijiet rigward effetti tal-klassi ta' mediċini newrolettiċi (sindromu newrolettiku malinn, prolungament tal-QT, diżkajnijżja tardiva) u sintomi ta' irtirar bħal ma huwa s-sindromu ta' lansjetà u d-dipressjoni.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING VERALIPRIDE (see Annex I)
Maltese: SOMMARJU TOTALI TA' L-EVALWAZZJONI XJENTIFIKA TA' PRODOTTI MEDIĊINALI LI FIHOM VERALIPRIDE (ara l-Anness I)
English: Psychiatric adverse events mainly referred to depressive and anxiety states have also been reported with veralipride.
Maltese: Reazzjonijiet psikjatriċi avversi prinċipalment b'referenza għal stati depressivi u ta' ansjetà ġew ukoll irrapportati b'veralipride.
English: • The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
Maltese: • Il-Kumitat ikkunsidra li reazzjonijiet newroloġiċi (diżkajnijżja, disturb ekstrapiramidali, issindromu ta' Parkinson) u reazzjonijiet psikjattriċi (dipressjoni, ansjetà, sindromu ta' l-irtirar) ġew irrapportati b'veralipride, inklużi diżkajnijżja tardiva li tista' tkun potenzjalment irriversibbli.
English: In order to avoid psychiatric AE, extrapyramidal symptoms and tardive dyskinesia, the MAH proposed a maximally allowed duration of 3 months veralipride treatment.
Maltese: Sabiex ikunu evitati episodji psikjatriċi avversi, sintomi ektrapiramidali u diskajnijżji tardivi, il-MAH ippropona tul ta' żmien ta' trattament massimu permess ta' 3 xhur.
English: Pharmaceutical Form Route of administration
Maltese: Qawwa Għamla Farmaċewtika
English: Veralipride treatment is contra-indicated in patients with prolactindependent tumours such as pituitary gland prolactinoma and breast cancer.
Maltese: Trattament b'veralipride huwa kontra-indikat f'pazjenti b'tumuri dipendenti fuq il-prolaktin bħalma huma prolaktinoma tal-glandola pitwitarja u l-kanċer tas-sider.
English: • The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause;
Maltese: • Il-Kumitat ikkunsidra li prodotti mediċinali li fihom veralipride urew effikaċja limitata fittrattament ta' fwawar assoċjati mal-menopawsa;
English: Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptoms associated with the menopause.
Maltese: Veralipride hija mediċina benzamide newrolettika indikata fit-trattament ta' sintomi vażomotorili assoċjati mal-menopawsa.
English: This included mainly 11 studies involving around 600 women, in which veralipride was compared with placebo, and two studies in around 100 women where it was compared with conjugated oestrogens.
Maltese: Dan kien jinkludi 11-il studju li involvew madwar 600 mara, li fihom veralipride tqabbel ma' plaċebo, u żewġ studji fuq madwar 100 mara fejn tqabbel ma' estroġeni ikkonġugati.
English: Italy
Maltese: Milano Italy
English: Lastly, QT-prolongation is a class-effect of dopamine-antagonists.
Maltese: Fl-aħħarnett, wieħed mill-effetti tal-klassi ta' l-antagonisti tad-dopamine huwa l-prolungament tal-QT.
English: In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Maltese: Minħabba t-tagħrif kliniku disponibbli, il-CHMP ikkonkluda li r-riskji assoċjati ma' l-użu ta' veralipride fit-trattament ta' fwawar assoċjati mal-menopawsa, b'mod partikolari r-reazzjonijiet newroloġiċi (diżkajnijżja, disturb ektrapiramidali, is-sindromu ta' Parkinson) u reazzjonijiet psikjatriċi (dipressjoni, ansjetà, sindromu ta' irtirar) jegħlbu l-benefiċċji limitati.
English: The CHMP concluded that the data submitted showed only limited effect of veralipride in the treatment of vasomotor symptoms associated with the menopause.
Maltese: Is-CHMP ikkonkluda li t-tagħrif sottomess wera biss effett limitat ta' veralipride fit-trattament ta' sintomi vażomotorili assoċjati mal-menopawsa.
English: Whereas
Maltese: Billi:
English: Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QTprolongation are considered a concern.
Maltese: Każijiet ta' diżkajnijżja tardiva mhux prevedibbli u potenzjalment irriversibbli, kif ukoll sintomi ekstrapiramidali bikrija, dipressjoni, ansjetà u reazzjonijiet ta' irtirar ġew irrapportati bi trattament b'veralipride; dawn ir-riskji flimkien mar-riskju ta' l-iperprolaktinimja, u r-riskju ta' l-effett tal-klassi fuq il-prolungament tal-QT huma ikkunsidrati ta' tħassib.
English: Overall, the restriction to limit the use of veralipride to 3 months in combination with monthly medical neurological examinations and breast monitoring is not considered adequate to limit the risk of all adverse effects reported with veralipride and adequately treat the vasomotor symptoms associated with the menopause.
Maltese: Kollox ma' kollox, ir-restrizzjoni biex ikun limitat l-użu ta' veralipride għal 3 xhur f'kumbinazzjoni ma' eżaminazzjonijiet newroloġiċi mediċi u monitoraġġ tas-sider, m'hijiex meqjusa adegwata biex ikun limitat ir-riskju ta' l-effetti avversi kollha irrapportati b'veralipride u jkunu ttrattati adegwatament is-sintomi vażomotorili assoċjati mal-menopawsa.
English: The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Maltese: Il-benefiċċju jista' jkun ikkwalifikat bħala wieħed limitat, madankollu id-daqs ta' l-effett ma jistax jiġi ikkwantifikat b'mod preċiż minħabba defiċjenzi metodoloġiċi ta' studji disponibbli (eż. fil-parti l-kbira tal-każijiet, valuri fil-linja bażi ma kinux iddikjarati, u b'hekk ma setgħetx issir valutazzjoni adegwata tat-titjib osservat; la s-sinjifikat statistiku u lanqas dak kliniku tad-daqs ta' dan l-effett ma seta' jiġi ikkwantifikat b'mod preċiż, minħabba li l-pjan statistiku ma kienx ċar jew kien assenti; il-preżentazzjoni tar-riżultati kienet dgħajfa).
English: In addition, hyperprolactinemia and the risk of QT prolongation are also concerns;
Maltese: Barra minn hekk, iperprolaktinimja u r-riskju ta' prolungament tal-QT huma wkoll ta' tħassib;
English: Invented name
Maltese: ANNESS I LISTA TA`
English: -Introduction of the contraindications in patients with Parkinson's disease, or in combination with other neuroleptics and dopaminergic agonists.
Maltese: -Introduzzjoni tal-kontra-indikazzjonijiet f'pazjenti b'marda tal-Parkinson, jew f'kumbinazzjoni ma' newrolettiċi u agonisti dopaminerġiċi oħrajn.
English: The CHMP also looked at other small studies.
Maltese: Is-CHMP studja wkoll studji żgħar oħra.
English: The CHMP therefore concluded on 19 July 2007 that the benefit/risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Maltese: Għaldaqstant, fid-19 ta' Lulju 2007, is-CHMP ikkonkluda li l-bilanċ ta' riskju/benefiċċju ta' prodotti mediċinali li fihom veralipride, m'huwiex wieħed pożittiv taħt kundizzjonijiet ta' użu normali.
English: The absence of cases of suggestive QT-prolongation in the database is not sufficient to conclude that this effect does not occur with veralipride.
Maltese: In-nuqqas ta' każijiet ta' prolungament tal-QT suġġestiv fid-database m'huwiex suffiċjenti biex wieħed jikkonkludi li dan l-effett ma jseħħx b'veralipride.