FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee considered that in view of the currently available safety data in order to maintain a favourable benefit-risk balance, these parenteral SABAs (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products should be contraindicated in patients at a gestational age less than 22 weeks, in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease and in patients with threatened abortion during the first and second trimester of gestation.
Maltese: Il-Kumitat ikkunsidra li fid-dawl tad-dejta attwalment disponibbli dwar is-sigurtà sabiex jinżamm bilanċ favorevoli tal-benefiċċju-riskju, dawn il-prodotti mediċinali li fihom SABAs parenterali (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline u isoxsuprine) għandhom jiġu kontraindikati f'pazjenti f'età ġestazzjonali ta' anqas minn 22 ġimgħa, f'pazjenti b'mard iskemiku pre-eżistenti tal-qalb jew f'dawk il-pazjenti b'fatturi sinifikanti ta' riskju għal mard iskemiku tal-qalb u f'pazjenti li kellhom theddida ta' abort matul l-ewwel u t-tieni trimestru ta' ġestazzjoni.
English: The available data showed that injectable forms are effective at supressing labour contractions in the short term (up to 48 hours).
Maltese: Id-dejta disponibbli wriet li l-forom injettabbli huma effettivi fis-soppressjoni tal-kontrazzjonijiet talħlas għal żmien qasir (sa 48 siegħa).
English: However, the CMDh considered that a minor change was necessary to the wording proposed in the conditions to the Marketing Authorisations (Annex IV).
Maltese: Madankollu, is-CMDh ikkunsidra li kien hemm il-ħtieġa ta' bidla minuri lill-kliem propost fil-kundizzjonijiet tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq (Anness IV).
English: In contrast to other SABAs, no maternal fatality and no case of myocardial infarction have been reported following hexoprenaline administration for tocolysis.
Maltese: B'kuntrast ma' SABAs oħra, ma ġiet irrapportata l-ebda fatalità materna u l-ebda każ ta' infart mijokardijaku wara l-għoti ta' hexoprenaline għal tokolosi.
English: Regardless of this, 18 serious cardiovascular cases have been identified in EudraVigilance showing that, not only predisposed, but also otherwise healthy subjects have developed serious cardiovascular complications.
Maltese: Irrispettivament minn dan, ġew identifikati 18-il każ kardjovaskulari serju f'EudraVigilance li juru li, mhux biss individwi predisposti, iżda wkoll individwi altrimenti b'saħħithom żviluppaw komplikazzjonijiet kardjovaskulari serji.
English: These cases of adverse events under ritodrine therapy included both welldocumented case reports from the literature and cases recorded by the MAH from spontaneous reporting from healthcare personnel or Health Authorities.
Maltese: Matul din ir-reviżjoni, ġew ivvalutati dejta minn studji kliniċi, rapportar wara t-tqegħid fis-suq u letteratura ppubblikata, fosthom linji gwida rilevanti għall-kura.
English: A review of safety data for fenoteral showed that the cardiovascular events tachycardia and palpitations were frequently reported in clinical studies and are listed as very common side effects of the drug.
Maltese: Ir-reviżjoni tad-dejta dwar is-sigurtà għal fenoteral uriet li l-avvenimenti kardjovaskulari takikardja u palpitazzjonijiet ġew irrappurtati b'mod frekwenti fl-istudji kliniċi u huma elenkati bħala effetti sekondarji komuni ħafna tal-mediċina.
English: The PRAC noted eight infant fatalities, two of which were in association with pulmonary oedema and cardiovascular events.
Maltese: Il-PRAC innota tmien imwiet ta' trabi, li tnejn minnhom kienu b'rabta ma' edema pulmonari u avvenimenti kardjovaskulari.
English: The seriousness of AEs seems to be directly related to the dose of ritodrine administered to the patient, but also to the treatment duration as most of life-threatening AEs occurred after prolonged ritodrine administration (>72h to months).
Maltese: Barra minn hekk, il-ħlas prematur huwa fattur stabbilit tar-riskju ta' morbidità u mortalità tat-trabi tat-twelid.
English: The authorised obstetric indications include partus prematurus, tocolysis (for some products use is restricted to particular weeks of gestation but for others no specific gestation period is specified), external cephalic version (ECV), and hyper-uterine contractility.
Maltese: L-indikazzjonijiet ostetriċi awtorizzati jinkludu partus prematurus, tokolosi (għal xi prodotti l-użu huwa ristrett għal ġimgħat partikolari ta' ġestazzjoni iżda għal oħrajn ma hemm l-ebda perjodu speċifiku ta' ġestazzjoni speċifikat), verżjoni ċefalika esterna (ECV), u iper-kontrattilità tal-utru.
English: • epilepsy.
Maltese: • epilessija.
English: EMA/229012/2010 EMEA/H/C/546
Maltese: EMA/229012/2010
English: Lyrica pregabalin
Maltese: Pregabalin
English: It is available as capsules (white: 25, 50 and 150 mg; white and orange: 75, 225 and 300 mg; orange: 100 mg; light orange: 200 mg) and as an oral solution (20 mg/ml).
Maltese: Huwa disponibbli f'forma ta' kapsuli (bojod: 25, 50 u 150 mg; bojod u oranġjo: 75, 225 u 300 mg; oranġjo: 100 mg; oranġjo ċar: 200 mg) u bħala soluzzjoni orali (20mg/ml).
English: The maximum dose is 600 mg per day.
Maltese: Id-doża massima hija ta' 600 mg.
English: This summary was last updated in 04-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 04-2010.
English: Lyrica is a medicine that contains the active substance pregabalin.
Maltese: Lyrica huwa mediċina li fih s-sustanza attiva pregabalin.
English: Lyrica has been compared with placebo (a dummy treatment) in 22 studies:
Maltese: Lyrica tqabbel ma' plaċebo (trattament finta) f'22 studju:
English: The active substance in Lyrica, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva f'Lyrica, pregabalin, hija simili fl-istruttura għall-aċidu butriku tal-gamma-amino (GABA) ‘newrotrażmettitur' tal-ġisem stess, iżda għandu effetti bijoloġiċi differenti ħafna.
English: This document is a summary of the European Public Assessment Report (EPAR) for Lyrica.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Lyrica.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Lyrica lil Pfizer Limited fis-6 ta' Lulju 2004.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: • disturb tal-ansjetà ġeneralizzat (ansjetà u nervi fit-tul dwar ħwejjeġ ta' kuljun).
English: • for epilepsy, there were three studies involving over 1,000 patients.
Maltese: • għall-epilessija, kien hemm tliet studji li involvew ‘il fuq minn 1,000 pazjent.
English: In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more.
Maltese: F'każ ta' epilessija, Lyrica naqqas in-numru ta' aċċessjonijiet: madwar 45% tal-pazjenti li jieħdu 60 mg ta' Lyrica u madwar 35% ta' dawk li jieħdu 300 mg ta' Lyrica kuljum kellhom tnaqqis ta' aċċessjonijiet b'50% jew aktar.
English: What is the risk associated with Lyrica?
Maltese: X'inhu r-riskju assoċjat ma' Lyrica?
English: • for generalised anxiety disorder, there were eight studies involving over 3,000 patients.
Maltese: • għal disturb tal-ansjetà ġeneralizzat, kien hemm tmien studji li involvew ‘il fuq minn 3,000 pazjent.
English: • neuropathic pain (pain due to nerve damage).
Maltese: • uġigħ newropatiku (uġigħ dovut għal ħsara fin-nervituri).
English: Why has Lyrica been approved?
Maltese: Għaliex ġie approvat Lyrica?
English: In peripheral neuropathic pain, 35% of the patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo.
Maltese: Għall-uġigħ newropatiku periferiku, 35% tal-pazjenti trattati b'Lyrica kellha tnaqqis fit-tabella tal-uġigħ ta' 50% jew aktar, meta mqabbla ma' 18% tal-pazjenti trattati bi plaċebo.
English: In central neuropathic pain, 22% of patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
Maltese: Għall-uġigħ newropatiku ċentrali, 22% tal-pazjenti trattati b'Lyrica kellha tnaqqis fit-tabella tal-uġigħ ta' 50% jew aktar, meta mqabbla ma' 8% tal-pazjenti trattati bi plaċebo.
English: After three to seven days, the dose can be increased to 300 mg per day.
Maltese: Wara tlieta jew sebat ijiem, id-doża tista' tiżdied għal 300 mg kuljum.
English: • for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles.
Maltese: • għall-uġigħ newropatiku periferiku, kien hemm għaxar studji li involvew ‘il fuq minn 3,000 pazjent, madwar nofshom kellhom newropatija dijabetika u n-nofs l-ieħor kellhom uġigħ wara l-ħruq ta' Sant'Antnin.
English: Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Maltese: Lyrica jista' jintuża għal uġigħ newropatiku periferiku, bħal uġigħ esperjenzat minn pazjenti dijabetiċi jew minn pazjenti li kellhom il-herpes zoster (ħruq ta' Sant'Antnin), u wġigħ newropatiku ċentrali, bħalma huwa wġigħ esperjenzat minn pazjenti li kellhom ħsara fil-mudullun tas-sinsla tad-dahar;
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Maltese: Innewrotrasmettituri huma sustanzi kimiċi li jippermettu li ċ-ċelluli nervużi jikkomunikaw ma' xulxin.
English: In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo.
Maltese: F'każ ta' disturb tal-ansjetà ġeneralizzat, Lyrica kien aktar effikaċi mill-plaċebo: 52% tal-pazjenti li jieħdu Lyrica kellhom titjib b'50% jew aktar, meta mqabbel ma' 38% tal-pazjenti li jieħdu plaċebo.
English: A further study was carried out in 137 patients with central neuropathic pain due to a spinal cord injury.
Maltese: Sar studju ieħor fuq 137 pazjent li jbatu b'uġigħ newropatiku ċentrali dovut għal ħsara tas-sinsla tad-dahar.
English: For the full list of all side effects reported with Lyrica, see the Package Leaflet.
Maltese: Għal lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Lyrica, ara l-Fuljett ta' Tagħrif.
English: The main measure of effectiveness was the change in the number of seizures after 11 to 12 weeks;
Maltese: Il-kejl prinċipali taleffikaċja kien it-tibdil fin-numru ta' aċċessjonijiet wara 11 sa 12-il-ġimgħa;
English: The CHMP decided that Lyrica's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Lyrica huma akbar mir-riskji tiegħu u rrakkomanda li Lyrica jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: This compared with about 10% of the patients taking placebo.
Maltese: Dan tqabbel ma' madwar 10% tal-pazjenti li kienu qed jieħdu plaċebo.
English: How has Lyrica been studied?
Maltese: Kif ġie studjat Lyrica?
English: The recommended starting dose of Lyrica is 150 mg per day, divided into two or three doses.
Maltese: Id-doża rakkomandata inizjali ta' Lyrica hija ta' 150 mg kuljum, maqsuma f'żewġ jew tliet dożi.
English: Other information about Lyrica:
Maltese: Aktar tagħrif dwar Lyrica:
English: The most common side effects with Lyrica (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Maltese: L-aktar effetti sekondarji komuni b'Lyrica (li dehru f'aktar minn pazjent 1 minn 10) huma sturdament u ħedla tan-ngħas.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Maltese: Dan inaqqas l-attività ta' xi ċelloli nervużi fil-moħħ u filmudullun tas-sinsla tad-dahar, billi jnaqqas ir-rilaxx ta' newrotrasmettituri oħrajn li huma involuti fluġigħ, l-epilessija u l-ansjetà.
English: Lyrica is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Maltese: Lyrica jintuża bħala ‘żieda' flimkien ma' trattament eżistenti f'pazjenti li kellhom aċċessjoni parzjali (epilessija severa li tibda f'parti speċifika tal-moħħ) li ma tistax tiġi kkontrollata bit-trattament attwali;
English: The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Maltese: Ilmod eżatt ta' kif jaħdem pregabalin mhuwiex totalment magħruf, iżda huwa maħsub li jaffettwa l-mod ta' kif il-kalċju jidħol fiċ-ċelloli nervużi.
English: The effectiveness of Lyrica was measured using a standard pain questionnaire;
Maltese: L-istudji damu sa 12 -il ġimgħa u l-effikaċja ta' Lyrica kienet imkejla bl-użu ta' kwestjonarju standard dwar l-uġiegħ;
English: Lyrica is used to treat adults with the following conditions:
Maltese: Lyrica jintuża għat-trattament ta' adulti li jbatu minn dan il-mard:
English: The full EPAR for Buccolam 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: Each syringe contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of midazolam.
Maltese: Kull siringa fiha 2.5 mg, 5 mg, 7.5 mg jew 10 mg ta' midazolam.
English: In the brain, GABA is involved in reducing the electrical activity.
Maltese: Filmoħħ, GABA huwa involut fit-tnaqqis fl-attività elettrika.
English: EPAR summary for the public midazolam
Maltese: Sommarju tal-EPAR għall-pubbliku midazolam
English: This summary was last updated in 09-2011.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi 09-2011.
English: Other information about Buccolam
Maltese: Informazzjoni oħra dwar Buccolam
English: Buccolam is a medicine that contains the active substance midazolam.
Maltese: Buccolam huwa mediċina li fiha s-sustanza attiva midazolam.
English: This is a summary of the European public assessment report (EPAR) for Buccolam.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Buccolam.
English: In the four studies, oromucosal midazolam was effective in stopping a seizure within 10 minutes in 65 to 78% of children compared with 41 to 85% of children who received rectal diazepam.
Maltese: Fl-erba' studji, midazolam għall-mukuża tal-ħalq kien effettiv fit-twaqqif ta' attakk fi żmien 10 minuti f'65 sa 78% tat-tfal meta mqabbel ma' 41 sa 85% tat-tfal li rċevew diazepam li jingħata mir-rektum.
English: The recommended dose ranges from 2.5.mg to 10 mg, depending on the child's age.
Maltese: Id-doża rakkomandata tvarja minn 2.5 mg għal 10 mg jiddependi mill-età tat-tifel/tifla.
English: The active substance in Buccolam is midazolam, a benzodiazepine, which acts as an anti-convulsant medicine.
Maltese: Is-sustanza attiva f'Buccolam hija midazolam, benzodiazepine, li taġixxi bħala mediċina kontra lkonvulżjonijet.
English: Buccolam is used to stop prolonged, acute (sudden) convulsive seizures in children and adolescents (from 3 months to less than 18 years of age).
Maltese: Buccolam jintuża biex iwaqqaf attakk konvulżiv imtawwal, akut (f'daqqa) fi tfal u adolexxenti (li għandhom bejn 3 xhur u inqas minn 18-il sena).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Buccolam on 5 September 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Buccolam fil-5 ta' Settembru 2011.
English: The most common side effects with Buccolam (seen in more than 1 patient in 10) are sedation, somnolence (sleepiness), depressed levels of consciousness, respiratory depression and nausea (feeling sick) and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Buccolam (li dehru f'aktar minn pazjent 1 minn kull 10) huma sedazzjoni, ngħas, livelli mnaqqsa ta' għarfien, tnaqqis respiratorju u nawsja (tħossok imdardar) u rimettar.
English: Why has Buccolam been approved?
Maltese: Għaliex ġie approvat Buccolam?
English: It must not be used in patients with myasthenia gravis (a disease causing muscle weakness), severe respiratory insufficiency (lung conditions that cause difficulty breathing), sleep apnoea syndrome (frequent interruption of breathing during sleep) or severe liver problems.
Maltese: Ma għandux jintuża f'pazjenti b'myasthenia gravis (marda li tikkawża dgħjufija tal-muskoli), insuffiċjenza respiratorja serja (kundizzjonijiet tal-pulmun li jikkawżaw diffikultà fit-teħid tan-nifs), sindromu ta' apnea fl-irqad (interruzzjoni frekwenti tat-teħid tan-nifs fl-irqad) jew problemi serji bil-fwied.
English: What is the risk associated with Buccolam?
Maltese: X'inhu r-riskju assoċjat ma' Buccolam?
English: If the seizure has not stopped within 10 minutes of giving Buccolam, they should seek medical help immediately.
Maltese: Jekk l-attakk ma jieqafx fi żmien 10 minuti minn meta jingħata Buccolam, għandhom ifittxu għajnuna medika minnufih.
English: What is Buccolam?
Maltese: X'inhu Buccolam?
English: In infants from 3 months to less than 6 months Buccolam should only be used within a hospital and where equipment is available for resuscitation and monitoring of the patient due to an increased risk respiratory depression (inhibition of breathing).
Maltese: Fi trabi ta' bejn 3 xhur u 6 xhur, Buccolam għandu jintuża biss ġewwa sptar u fejn ikun hemm apparat ta' risuxitazzjoni u ta' monitoraġġ tal-pazjent disponibbli minħabba żieda fir-riskju ta' tnaqqis respiratorju (inibizzjoni tat-teħid tan-nifs).
English: Reports from the published literature confirmed that oromucosal midazolam is effective in stopping seizures in children.
Maltese: Rapporti mil-litteratura ppubblikata kkonfermaw li midazolam għall-mukuża tal-ħalq huwa effettiv fittwaqqif tal-attakki fit-tfal.
English: The company presented results of five key studies from the published literature.
Maltese: Il-kumpanija ppreżentat riżultati ta' ħames studji ewlenin mil-litteratura ppubblikata.
English: With regard to side effects, the medicine may cause respiratory depression, as is the case with other comparable medicines, but is generally well tolerated.
Maltese: Fir-rigward tal-effetti sekondarji, il-mediċini jistgħu jikkawżaw tnaqqis respiratorju, bħalma jiġri fil-każ ta' mediċini komparabbli oħrajn, iżda ġeneralment huwa ttollerat sew.
English: How has Buccolam been studied?
Maltese: Kif ġie studjat Buccolam?
English: The fifth study compared buccal midazolam with intravenous diazepam, where the measure of effectiveness was the treatment's ability to stop the seizure within 5 minutes.
Maltese: Il-ħames studju qabbel midazolam li jingħata mill-ħalq ma' diazepam li jingħata ġol-vina, fejn il-kejl tal-effikaċja kien l-abilità tal-kura li twaqqaf lattakk fi żmien 5 minuti.
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Maltese: Newrotrasmettituri bħalma huma GABA huma kimiċi li jippermettu liċ-ċelloli tan-nervituri sabiex jikkomunikaw ma' xulxin.
English: In four of these studies, oromucosal midazolam was compared with rectal diazepam and the measure of effectiveness was the treatment's ability to stop the seizure within 10 minutes.
Maltese: F'erbgħa minn dawn l-istudji, midazolam għall-mukuża tal-ħalq tqabbel ma' diazepam li jingħata fir-rektum u l-kejl tal-effikaċja kien l-abilità tal-kura li twaqqaf l-attakk fi żmien 10 minuti.
English: For the full list of all side effects reported with Buccolam, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Buccolam, ara l-fuljett ta' tagħrif.
English: These studies looked at children with acute convulsions and compared the effects of oromucosal midazolam with those of diazepam (another benzodiazepine) when given intravenously (into a vein) or rectally (into the rectum).
Maltese: Dawn l-istudji ħarsu lejn tfal b'konvulżjonijiet akuti u qabblu l-effetti ta' midazolam għall-mukuża tal-ħalq ma' dawk ta' diazepam (benzodiazepine ieħor) meta mogħti ġo vina jew fir-rektum.
English: Package size l t o r
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: Content (concentration)
Maltese: Il-Kontenut
English: l t o r
Maltese: Daqs tal-Pakkett t x
English: EMA/361680/2011 EMEA/H/C/002104
Maltese: 19 ta' Mejju 2011 EMA/361680/2011 EMEA/H/C/002104
English: What is Joicela?
Maltese: X'inhu Joicela?
English: Joicela is a medicine that contains the active substance lumiracoxib.
Maltese: Joicela huwa mediċina li fiha s-sustanza attiva lumiracoxib.
English: Two of the studies involved 3,235 patients with knee osteoarthritis while the third study involved 1,262 patients with hip osteoarthritis.
Maltese: Tnejn mill-istudji involvew 3,235 pazjent b'osteoartrite tal-irkoppa filwaqt li t-tielet studju involva 1,262 pazjenti b'osteoartrite tal-ġenbejn.
English: The active substance in Joicela, lumiracoxib, is a selective ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'.
Maltese: Is-sustanza attiva f'Joicela, lumiracoxib, hija ‘mediċina kontra l-infjammazzjoni mhux sterojdali' (NSAID) li tappartjeni għall-grupp ta' ‘inibituri ta' cyclo-oxygenase 2 (COX-2)‘.
English: Withdrawal of the marketing authorisation application for Joicela (lumiracoxib) EMA/917506/2011
Maltese: Irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Joicela (lumiracoxib) EMA/917520/2011
English: Withdrawal of the marketing authorisation application for Joicela (lumiracoxib)
Maltese: Irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Joicela (lumiracoxib)
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Maltese: Hija timblokka l-enzima COX-2, li tirriżulta fi tnaqqis fil-produzzjoni ta' prostaglandins, sustanzi li huma involuti fil-proċess ta' infjammazzjoni.
English: What was Joicela expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Joicela?
English: DQA1*0102 is thought to increase the risk of liver toxicity in patients taking Joicela.
Maltese: DQA1*0102 huwa maħsub li jżid ir-riskju ta' tossiċità tal-fwied f'pazjenti li jkunu qegħdin jieħdu Joicela.
English: Joicela was compared with celecoxib (another medicine used in osteoarthritis) and placebo (a dummy treatment) in three main studies.
Maltese: Joicela tqabbel ma' celecoxib (mediċina oħra użata fl-osteoartrite) u ma' plaċebo (kura finta) fi tliet studji ewlenin.
English: On 15 April 2011, Novartis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joicela for the symptomatic relief in the treatment of osteoarthritis of the knee and hip in patients who are not carriers of the DQA1*0102 allele.
Maltese: Fil-15 ta' April 2011, Novartis innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Joicela għas-serħan mis-sintomi fil-kura tal-osteoartrite tal-irkoppa u tal-ġenbejn f'pazjenti li mhumiex ġarriera tal-allele DQA1*0102.
English: Joicela was expected to be used to relieve the symptoms of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of a gene variant called ‘DQA1*0102'.
Maltese: Joicela kien mistenni li jintuża biex iserraħ mis-sintomi tal-osteoartrite (nefħa u uġigħ fil-ġogi) talirkoppa u l-ġenbejn f'adulti li mhumiex ġarriera ta' varjant ta' ġene msejjaħ ‘DQA1*0102'.