FrancophonIA/ELRC3.0 huggingface dataset:
English: Scintimun contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Maltese: Scintimun fih inqas minn 1 mmol ta' sodium (23 mg) f'kull fjala, i.e. huwa essenzjalment ‘ħieles mis-sodju'.
English: For an administered activity of 800 MBq the typical radiation dose to the target organ bone is 14.2 mGy and the typical radiation doses to the critical organs, bone marrow, spleen and kidneys are 19.4 mGy, 21.7 mGy, and 16.8 mGy respectively.
Maltese: Għal attività mogħtija ta' 800 MBq id-doża ta' radjazzjoni tipika lil għadam tal-organu fil-mira hija ta' 14.2 mGy u d-doża ta' radjazzjoni tipika lill-organi kritiċi, mudullun, milsa u kliewi hija ta'
English: For repeated use, see section 4.4.
Maltese: Għal użu ripetut, ara sezzjoni 4.4.
English: Tc) solution, the technetium (
Maltese: - Is-sustanzi eluwati għandhom jittieħdu biss minn ġeneratur ta' Technetium (
English: Only limited data is available about binding of technetium (99mTc) besilesomab to CarcinoEmbryonic
Maltese: Hemm biss dejta ristretta dwar l-irbit ta' technetium (99mTc) besilesomab mal-Antiġen
English: Renal impairment / Hepatic impairment
Maltese: Indeboliment tal-kliewi / Indeboliment tal-fwied
English: Introduce the ITLC-SG or RBM-1 paper strip immediately into the chromatography tank using forceps to avoid formation of pertechnetate (99mTc) due to oxygen.
Maltese: Daħħal l-istrippa tal-karta tal-ITLC-SG jew RBM-1 minnufih ġot-tank tal-kromatografija permezz ta' pinzetta sabiex tevita l-formazzjoni ta' pertechnetate (99mTc) minħabba l-ossiġenu.
English: Containers: appropriate containers such as chromatography tank or 1 000 mL Erlenmeyer flasks.
Maltese: - Solvent: methyl ethyl ketone (MEK) - Reċipjenti: reċipjenti xierqa bħal tank tal-kromatografija jew fliexken Erlenmeyer tal1 000 mL.
English: Pregnancy The use of besilesomab is contraindicated in pregnant women (see section 4.3).
Maltese: L-użu ta' besilesomab huwa kontraindikat f'nisa tqal (ara sezzjoni 4.3).
English: The low renal clearance of activity (0.2 L/h for a glomerular filtration rate around 7 L/h) indicates that the kidney is not the major route of besilesomab elimination.
Maltese: It-tneħħija baxxa mill-kliewi tal attività (0.2 L/h għal rata ta' filtrazzjoni glomerulari ta' madwar 7 L/siegħa) tindika li l-kliewi mhumiex il-passaġġ ewlieni tal-eliminazzjoni ta' besilesomab.
English: Administration of murine monoclonal antibodies can lead to the development of Human Anti-Mouse Antibodies (HAMA).
Maltese: L-għoti ta' antikorpi monoklonali murini jista' jwassal għal l-iżvillup ta'Antikorpi Umani kontra l-Ġurdien (HAMA).
English: The radiochemical purity (the percentage of bound Technetium (99mTc)) must be more than or equal to 95 %.
Maltese: Il-purità radjukimika (il-perċentwali ta' Technetium (99mTc) marbut) għandu jkun aktar minn jew ugwali għal 95 %.
English: After 1 min, check that the content of the vial of Scintimun has completely dissolved.
Maltese: Wara 1 min, iċċekkja li l-kontenut tal-kunjett ta' Scintimun ikun inħall kompletament.
English: MedDRA System Organ Classes
Maltese: Assorbiment mill-organi
English: Solvent: methyl ethyl ketone (MEK)
Maltese: Il-Musrana ż-Żgħira Mudullun (aħmar)
English: Antigen (CEA) expressing tumours in vivo.
Maltese: KarcinoEmbrijoniku (CarcinoEmbryonia Antogen, CEA) li jwassal għal tumuri in vivo.
English: Pack sizes:
Maltese: Eċċipjenti b'effett magħruf:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of Scintimun contains 1 mg of besilesomab
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kunjett ta' Scintimun fih 1 mg ta' besilesomab
English: About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun.
Maltese: Madwar 14 minn 100 pazjent li jieħdu din l-injezzjoni nstabu li jipproduċu antikorpi fid-demm tagħhom li jirreaġixxi kontra l-antikorpi preżenti f'Scintimun.
English: 10 min after the addition of pertechnetate (99mTc) the solution is ready for injection.
Maltese: 10 min wara li tkun żidt il-pertechnetate (99mTc) is-soluzzjoni hi lesta għall-injezzjoni.
English: Since allergic reactions to the murine protein cannot be excluded, cardiovascular treatment, corticosteroids, and antihistamines must be available during administration of the product.
Maltese: Peress li reazzjonijiet allerġiċi għal proteina murina ma jistgħux jiġu esklużi, trattament kardjovaskulari, kortikosterojdi, u anti-istaminiċi għandhom ikunu disponibbli waqt l-għoti tal prodott.
English: Scintimun contains sorbitol therefore patients with rare hereditary problems of fructose intolerance should not be administered this product.
Maltese: Scintimun fih sorbitol u għalhekk pazjenti bi problemi ereditarji rari ta' intolleranza għal fruttozju m'għandhomx jingħataw dan il-prodott.
English: Dispose of radioactive waste in accordance with local regulations.
Maltese: Armi l-iskart radjuattiv b'mod konformi mar-regolamenti lokali
English: Method of preparation To ensure the highest radiolabelling efficiency: Radiolabelling is performed using freshly eluted sodium pertechnetate (99mTc).
Maltese: Tikketta addizzjonali wara r-rikostituzzjoni u r-radjutikkettar b'soluzzjoni ta' sodium pertechnetate (99mTc).
English: Pancreas
Maltese: Proċedura
English: Scintimun is a sterile powder containing 1 mg of besilesomab per vial Scintimun.
Maltese: Scintimun huwa trab sterili li fih 1 mg ta' besilesomab f'kull kunjett ta' Scintimun.
English: For storage conditions after reconstitution and radiolabelling of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara r-rikostituzzjoni u r-radjutikkettar tal-prodott mediċinali, ara sezzjoni 6.3.
English: Scintimun vial:
Maltese: Kunjett ta' Scintimun
English: Adsorbent: strips (2.5 x 20 cm) for thin layer chromatography coated with silica gel (ITLC-SG) or for paper chromatography (RBM-1).
Maltese: (ITLC-SG ) jew għall-kromatografija tal-karta (RBM-1).
English: One vial of Scintimun contains 1 mg of besilesomab.
Maltese: Kull kunjett ta' Scintimun fih 1 mg ta' besilesomab.
English: Testis
Maltese: Besilesomab
English: Measurement of radioactivity levels in urine shows that up to 14 % of the administered activity is excreted via the bladder during the 24 h post-injection.
Maltese: Kejl tal-livell ta' radjuattività fl-awrina jindika li sa 14 % tal-attivita amministrata tiġi eliminata mill-bużżieqa tal-awrina matul l-24 siegħa ta' wara l-injezzjoni.
English: Bone marrow (red) Muscles
Maltese: Muskoli Ovarji Frixa
English: Take a vial of Solvent for Scintimun (yellow crimped aluminium capsule) from the kit.
Maltese: Ħu kunjett ta' Solvent għal Scintimun (kapsula tal-aluminju pjegata) minn ġol-kitt.
English: Where, % free technetium (99mTc) =
Maltese: sodium pertechnetate (99mTc).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION (99mTc)- Scintimun
Maltese: (99mTc)- Scintimun
English: Data on repeated dosing of Scintimun are very limited.
Maltese: Dejta dwar l-użu ripetut ta' Scintimun huwa ristrett ħafna.
English: Bladder
Maltese: Pożoloġija
English: Thyroid
Maltese: Treddigħ
English: After correcting for the decay of radionuclide, the calculated half-life of the early phase is 0.5 h whereas the late phase shows a half-life of elimination of 16 h.
Maltese: Wara li jsiru lkorrezzjonijiet għad-dekompożizzjoni tar-radjunuklide, il-half-life kkalkulata tal-fażi bikrija hi 0.5 sigħat filwaqt li l-fażi tardiva turi half-life ta' eliminazzjoni ta' 16-il siegħa.
English: Reporting of suspected adverse reactions
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Maltese: METODU TA' KIF GĦANDU JINGĦATA Aqra l-fuljett tal-pakkett qabel tuża.
English: Preclinical data obtained with the non-radioactive compound reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose and repeated-dose toxicity, although antimurine antibodies were found in all dose groups (including controls) in a repeated-dose study in monkeys.
Maltese: Studji ta' qabel l-użu kliniku miksuba bil-kompost mhux radjuattiv ma juru ebda periklu speċjali ta' sigurtà farmakoloġika, effett tossiku minn doża waħda u dożi ripetuti, għalkemm antikorpi awtoimmuni rriżultaw fil-gruppi ta' kull doża (li jinkludu l-kontrolli) fi studju b'dożi ripetuti fuq ixxadini.
English: The frequencies are based on the most recent clinical trial and non interventional safety survey.
Maltese: Il-frekwenzi huma bbażati fuq l-aktar prova klinika riċenti u stħarriġ fuq is-sigurtà mhux intervenzjonali.
English: Thymus
Maltese: Uteru
English: Using a hypodermic syringe, introduce through the rubber seal 2-7 mL of pertechnetate (99mTc) (the eluate complies with the requirements of current Eur.
Maltese: minħabba n-natura tal-molekula u l-half-life qasira ta' technetium (99mTc), besilesomab, l-aġġustament fid-doża mhux meħtieġ f'xi pazjenti.
English: A risk to a breast-fed child cannot be excluded.
Maltese: Riskju għal wild li qed jitredda' ma jistax jiġi eskluż.
English: Besilesomab is a murine immunoglobulin of IgG1 isotype that specifically binds to NCA-95 (non specific cross-reacting antigen 95), an epitope expressed at the cell membrane of granulocytes and granulocyte precursors.
Maltese: Sustanzi attivi li jimpedixxu l-infjammazjoni jew jaffettwaw is-sistema ematopojetika (bħal antibijotiċi u kortikosterojdi) jistgħu jwasslu għal riżultati negattivi foloz.
English: Six hours after injection, about 1.5 % of the whole body radioactivity is found in the liver whereas about 3.0 % is found in the spleen.
Maltese: Sitt sigħat wara l-injezzjoni, madwar 1.5 % tar-radjuattività sħiħa tal-ġisem tinsab fil-fwied filwaqt li madwar 3.0 % tinsab fil-milsa.
English: PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation.
Maltese: U KONTENUT Sett għall-preparazzjoni radjufarmaċewtika
English: Materials and reagents
Maltese: Materjali u soluzzjonijiet
English: Shake smoothly.
Maltese: Ż-ŻGĦAR EWLENIN
English: There are currently no criteria to distinguish infection and inflammation by means of Scintimun imaging.
Maltese: Interpretazzjoni tal-immaġini Attwalment mhemmx kriterji li jiddistingwu infezzjoni u infjammazzjoni bl-immaġini bi Scintimun.
English: Ovaries
Maltese: Ġilda
English: Elderly No dose adjustment is required.
Maltese: Ksib ta' immaġini addizzjonali
English: Colon
Maltese: OĦRAJN
English: Trace a starting line 2.5 cm from the bottom of the paper strip.
Maltese: Intraċċa linja tal-bidu 2.5 ċm millqiegħ tal-istrippa tal-karta.
English: Development of human anti-mouse antibodies reacting against the antibody in Scintimun (antibody of the mouse cells) with a risk of allergic reaction
Maltese: Żvilupp ta' antikorpi li jirreaġixxu kontra l-antikorp fi Scintimun (antikorp kontra ċelluli talġurdien) b'riskju ta' reazzjoni allerġika.
English: GERMANY
Maltese: Franza
English: Myalgia, arthralgia
Maltese: OĦRA, JEKK MEĦTIEĠA
English: Eluates should only be taken from a technetium (99mTc)-generator that has been eluted within the past 24 hours (i.e. with less than 24 h in-grow).
Maltese: Tc) li jkun ġie eluwat fl-aħħar 24 siegħa (i.e. f'inqas minn 24 siegħa in-grow).
English: The full EPAR for Neparvis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Neparvis is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 mg valsartan).
Maltese: Neparvis jiġi bħala pilloli (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, u 97 mg sacubitril / 103 mg valsartan).
English: Why is Neparvis approved?
Maltese: Għaliex ġie approvat Neparvis?
English: Other information about Neparvis
Maltese: Informazzjoni oħra dwar Neparvis
English: This is a summary of the European public assessment report (EPAR) for Neparvis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Neparvis.
English: What are the risks associated with Neparvis?
Maltese: X'inhuma r-riskji assoċjati ma' Neparvis?
English: The study was stopped early because there was compelling evidence that Neparvis was more effective than enalapril.
Maltese: L-istudju twaqqaf qabel għax kien hemm evidenza konvinċenti li Neparvis kien aktar effikaċi minn enalapril.
English: In the group treated with Neparvis, 21.8% (914 of 4,187) patients either died as a result of heart and circulation problems or were admitted to hospital with heart failure compared to 26.5% (1,117 of 4,212) patients treated with enalapril.
Maltese: Fil-grupp ikkurat b'Neparvis, 21.8% (914 minn 4,187) tal-pazjenti mietu jew bħala riżultat ta' problemi tal-qalb u taċ-ċirkolazzjoni jew iddaħħlu l-isptar b'insuffiċjenza talqalb meta mqabbel ma' 26.
English: The two active substances in Neparvis, sacubitril and valsartan, work in different ways.
Maltese: Iż-żewġ sustanzi attivi f'Neparvis, is-sacubitril u l-valsartan, jaħdmu b'modi differenti.
English: Sacubitril blocks the breakdown of natriuretic peptides produced in the body.
Maltese: Is-sacubitril timblokka t-tkissir tal-peptidi natrijuretiċi prodotti fil-ġisem.
English: The recommended starting dose is one tablet of Neparvis 49 mg / 51 mg twice a day and the dose is then doubled after 2 to 4 weeks to 97 mg / 103 mg twice a day.
Maltese: Id-doża rakkomandata tal-bidu hija ta' pillola waħda ta' Neparvis 49 mg / 51 mg darbtejn kuljum u d-doża mbagħad tiġi rduppjata wara ġimagħtejn sa 4 ġimgħat għal 97 mg / 103 mg darbtejn kuljum.
English: Neparvis tablets are taken twice a day.
Maltese: Il-pilloli ta' Neparvis jittieħdu darbtejn kuljum.
English: A potentially severe side effect, angioedema (rapid swelling of deeper skin tissues as well as the tissues around the throat, causing breathing difficulty), can occur uncommonly (affecting fewer than 1 in 100 people).
Maltese: Effett sekondarju potenzjalment sever, anġjoedema (nefħa mgħaġġla ta' tessuti tal-ġilda aktar fil-fond kif ukoll tat-tessuti madwar il-gerżuma, li jikkawżaw diffikultà fit-teħid tan-nifs), jista' jseħħ b'mod mhux komuni (jaffettwa anqas minn persuna waħda minn kull 100 persuna).
English: A risk management plan has been developed to ensure that Neparvis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Neparvis jintuża bl-aktar mod sigur possibbli.
English: Natriuretic peptides also reduce blood pressure and protect the heart from developing fibrosis (scar tissue) that occurs in heart failure.
Maltese: Il-peptidi natrijuretiċi jnaqqsu wkoll il-pressjoni tad-demm u jipproteġu l-qalb milli tiżviluppa fibrożi (tessuti taċ-ċikatriċi) li sseħħ f'insuffiċjenza tal-qalb.
English: Neparvis is a heart medicine that contains the active substances sacubitril and valsartan.
Maltese: Neparvis huwa mediċina tal-qalb li fiha s-sustanzi attivi sacubitril u valsartan.
English: The company that makes Entresto has agreed that its scientific data can be used for Neparvis (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Entresto qablet li d-data xjentifika tagħha tista' tintuża għal Neparvis (“kunsens infurmat”).
English: How does Neparvis work?
Maltese: Kif jintuża Neparvis?
English: It is used in adults with long-term heart failure who have symptoms of the disease.
Maltese: Tintuża f'adulti li jbatu minn insuffiċjenza tal-qalb fit-tul li għandhom sintomi tal-marda.
English: For the full list of all side effects reported with Neparvis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Neparvis, ara l-fuljett ta' tagħrif.
English: Valsartan is an ‘angiotensin-II-receptor antagonist', which means that it blocks the action of a hormone called angiotensin II.
Maltese: Il-valsartan huwa tip ta' 'antagonista tar-riċettur tal-anġjotensina
English: It is not intended to provide practical advice on how to use Neparvis.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Neparvis.
English: Valsartan, one of the active substances in the medicine, is well established for the treatment of high blood pressure and heart failure; its side effects are well known.
Maltese: Il-valsartan, waħda mis-sustanzi attivi fil-mediċina, hija stabbilita sew għall-kura ta' pressjoni għolja tad-demm u insuffiċjenza tal-qalb; l-effetti sekondarji tagħha huma magħrufin sew.
English: In the study, Neparvis was compared to enalapril, another medicine used for heart failure.
Maltese: Fl-istudju ewlieni, Neparvis tqabbel ma' enalapril, mediċina oħra użata għall-insuffiċjenza tal-qalb.
English: The serious side effects of Neparvis in the main study were similar to those of enalapril, which is already authorised for use in heart failure.
Maltese: L-effetti sekondarji serji ta' Neparvis fl-istudju ewlieni kienu simili għal dawk ta' enalapril, li diġà huwa awtorizzat għall-użu f'insuffiċjenza tal-qalb.
English: Neparvis must not be taken with medicines known as ACE inhibitors (which are used to treat heart failure and high blood pressure).
Maltese: Neparvis ma għandux jittieħed ma' mediċini magħrufin bħala inibituri ACE (li jintużaw biex jikkuraw insuffiċjenza tal-qalb u pressjoni għolja tad-demm).
English: The most common side effects with Neparvis (which may affect more than 1 in 10 people) are high blood potassium levels, low blood pressure and the kidneys working less well.
Maltese: L-effetti sekondarji l-aktar komuni b'Neparvis (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma livelli għoljin ta' potassju fid-demm, pressjoni baxxa tad-demm u l-kliewi jaħdmu b'mod anqas tajjeb.
English: Neparvis has been shown to be effective in treating heart failure in one main study.
Maltese: Neparvis intwera li huwa effettiv fil-kura ta' insuffiċjenza tal-qalb fi studju ewlieni.
English: Patients in the study had long-term heart failure with symptoms of the disease and reduced ejection fraction (the proportion of blood leaving the heart).
Maltese: Il-pazjenti f'dan listudju kellhom insuffiċjenza tal-qalb fit-tul b'sintomi tal-marda u tnaqqis tal-frazzjoni ta' tneħħija (ilproporzjon ta' demm li jħalli l-qalb).
English: What measures are being taken to ensure the safe and effective use of Neparvis?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effikaċi ta' Neparvis?
English: Cutaneous use Multidose container with airless pump (PP/TPO/HDPE)
Maltese: 1 pompa dożi b'pompa bla arja (PP/TPO/HDPE)
English: Immediate Packaging Content (concentration)
Maltese: (konċentrazzjoni) tal-pakkett
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (UE) Isem Qawwa Għamla
English: 1 pump
Maltese: Daqs
English: Strength Pharmaceutical Form
Maltese: farmaċewtika jingħata mal-prodott
English: Pack size
Maltese: Il-pakkett li jmiss Kontenut
English: 3 inhalers with 60 actuations
Maltese: 3 inalaturi b'60 attwazzjoni
English: 17 December 2009 EMA/809491/2009 EMEA/H/C/471
Maltese: EMEA/H/C/471
English: The evaluation was withdrawn after ‘day 90'.
Maltese: L-evalwazzjoni ġiet irtirata wara ‘jum 90'.
English: The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Abilify, aripiprazole, hija mediċina antipsikotika.
English: At the start of the study, the patients were put on an eight-week course of an antidepressant (escitalopram, sertraline, venlafaxine, fluoxetine or paroxetine).
Maltese: Fil-bidu tal-istudju, il-pazjenti tpoġġew fuq kors ta' tmien ġimgħat ta' antidipressant (escitalopram, sertraline, venlafaxine, fluoxetine jew paroxetine).
English: Abilify is a medicine that contains the active substance aripiprazole.
Maltese: Abilify huwa mediċina li fiha s-sustanza attiva aripiprazole.
English: On 17 November 2009, Otsuka Pharmaceutical Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Abilify, in the treatment of resistant major depressive episodes.
Maltese: Fis-17 ta' Novembru 2009, Otsuka Pharmaceutical Europe Ltd. għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) li hija tixtieq tirtira l-applikazzjoni tagħha għal indikazzjoni ġdida għal Abilify, fit-trattament ta' episodji dipressivi maġġuri reżistenti.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: F'liema stadju tal-evalwazzjoni kienet l-applikazzjoni meta ġiet irtirata?
English: Since dopamine and 5-hydroxytryptamine are involved in major depression, Abilify is expected to help to normalise the activity of the brain when it is added to antidepressants, reducing the symptoms of major depressive episodes.
Maltese: Billi dopamine u 5-hydroxytryptamine huma involuti f'depressjoni maġġuri, Abilify huwa mistenni li jgħin sabiex jinnormalizza l-attività tal-moħħ meta jiżdied mal-antidipressanti, u hekk inaqqas is-sintomi talepisodji dipressivi maġġuri.
English: It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth), an oral solution and a solution for injection.
Maltese: Huwa jiġi bħala pilloli, pilloli li jinħallu filħalq, soluzzjoni orali u soluzzjoni għal injezzjoni.
English: What was Abilify expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Abilify?
English: Abilify has been authorised since June 2004.
Maltese: Abilify ilu awtorizzat f'Ġunju 2004.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: Dan ifisser li l-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: The 1,090 patients who did not respond to this antidepressant then added either Abilify or placebo (a dummy treatment).
Maltese: L-1,090 pazjent li ma rrispondewx għal dan l-antidipressant imbagħad żiedu jew Abilify jew plaċebo (trattament finta).
English: What is happening with Abilify for the treatment of schizophrenia and the treatment and prevention of manic episodes in bipolar I disorder?
Maltese: X'se jiġri b'Aibilify għat-trattament tal-iskiżofrenija u lprevenzjoni tal-episodji ta' manija f'disturb bipolari tat-tip I?
English: The Committee was also concerned that there was no long-term information from ‘double-blind' studies looking at the maintenance of Abilify's effects and its ability to prevent depression coming back.
Maltese: IlKumitat kien imħasseb ukoll li ma kien hemm ebda informazzjoni minn studji ‘double-blind' li ħarsu lejn iż-żamma tal-effetti ta' Abilify u l-ħila tiegħu li jimpedixxi r-ritorn tad-dipressjoni.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Maltese: Dan ifixkel is-sinjali trasmessi bejn iċ-ċelloli tal-moħħ min-‘newrotrasmettituri', sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri li jikkomunikaw ma' xulxin.
English: It is already used to treat schizophrenia, and to treat and prevent manic episodes (periods of extremely high mood) in patients with bipolar I disorder.
Maltese: Huwa diġà jintuża għat-trattament tal-iskiżofrenija, u għattrattament u l-evitar ta' episodji ta' manija (perjodi ta' burdata għolja ħafna) f'pazjenti b'disturb pilolari tat-tip I.
English: The full European Public Assessment Report for Abilify is available here.
Maltese: Ir-Rapport ta' Valutazzjoni Pubblika Ewropew sħiħ għal Abilify jista' jinstab hawnhekk.
English: The short-term studies were ‘double-blind', which means that neither the patients nor the investigators knew which patients were receiving Abilify and which were receiving placebo.
Maltese: Listudji fuq perjodu qasir kienu ‘double-blind', li jfisser li la l-pazjenti u lanqas l-investigaturi ma kienu jafu liema pazjenti kienu qegħdin jirċievu Abilify u liema kienu qegħdin jirċievu l-plaċebo.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Abilify?
Maltese: X'inhuma l-konsegwenzi tal-irtirar għall-pazjenti fi provi kliniċi jew fi programmi b'użu ta' kompassjoni li kienu qegħdin jużaw Abilify?