FrancophonIA/ELRC3.0 huggingface dataset:
English: Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases.
Maltese: Il-mediċini ta' fenspiride jiġu bħala ġulepp jew pilloli u jintużaw f'adulti u fi tfal mill-età ta' sentejn biex itaffu s-sogħla li tirriżulta minn mard tal-pulmun.
English: The PRAC recommendation will now be implemented by EU Member States, Iceland, Lichtenstein and Norway.
Maltese: Ir-rakkomandazzjoni tal-PRAC issa ser tiġi implimentata mill-Istati Membri tal-UE, mill-Iżlanda, milLiechtenstein u min-Norveġja.
English: • Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines.
Maltese: • Il-pazjenti huma biss f'riskju ta' problemi fir-ritmu tal-qalb bi fenspiride waqt li jkunu qed jieħdu dawn il-mediċini.
English: 1 Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human
Maltese: 1 Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem
English: Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride.
Maltese: Il-problemi fir-ritmu tal-qalb jistgħu jkunu serji u jseħħu f'daqqa waħda, u mhux fattibbli li jiġu identifikati minn qabel il-pazjenti li jistgħu jkunu f'riskju ta' dawn il-problemi b'fenspiride.
English: Rua do Centro Cultural, 13 1749-066 Lisboa Portugal
Maltese: Rua do Centro Cultural, 13 1749-066 Lisboa
English: Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Maltese: Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244
English: 00-113 Warsaw Poland
Maltese: 00-113 Warsaw Il-Polonja
English: Trancopal Dolo capsule
Maltese: Trancopal Dolo kapsula
English: MEDA PHARMA S.p.A., Viale Brenta 18, 20139 Milano Italy
Maltese: MEDA PHARMA S.p.A., Viale Brenta 18, 20139 Milano L-Italja
English: Trancopal Dolo Suppositorien 150 mg suppository rectal use
Maltese: Trancopal Dolo Suppositorien 150 mg suppositorju
English: kabelovny 130, Dolní Mecholupy
Maltese: Ul. kabelovny 130, Dolní Mecholupy
English: Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o.
Maltese: TEVA Pharmaceuticals Slovakia, s.r.o.
English: 61352 Bad Homburg v. d. H. Germany
Maltese: 61352 Bad Homburg v. d. H. Il-Ġermanja
English: 55218 Ingelheim Germany
Maltese: 55218 Ingelheim Il-Ġermanja
English: Katadolon Kinderzäpfchen suppository rectal use
Maltese: Katadolon Kinderzäpfchen suppositorju
English: Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Germany
Maltese: Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Il-Ġermanja
English: Katadolon Zäpfchen suppository rectal use
Maltese: Katadolon Zäpfchen suppositorju
English: Dolokadin einmal täglich prolonged release tablet
Maltese: Dolokadin einmal täglich pillola li terħi l-mediċina bil-mod
English: Kabelovny 130 102 37 Praha 10 Czech Republic
Maltese: Kabelovny 130 102 37 Praha 10
English: 164,5 mg / 3 ml solution for injection intramuscular use
Maltese: 164,5 mg / 3 ml soluzzjoni għall-injezzjoni uża ġol-muskolu
English: 61352 Bad Homburg Germany
Maltese: 61352 Bad Homburg Il-Ġermanja
English: AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Maltese: AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm
English: 102 37, Praga 10, Czech Republic
Maltese: 102 37, Praga 10, Ir-Repubblika Ċeka
English: Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Maltese: Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm
English: Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Maltese: Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm
English: FLUPIZEN 100 mg capsule
Maltese: FLUPIZEN 100 mg kapsula
English: Flupirtinmaleat Winthrop 400 mg Retardtabletten prolonged release tablet
Maltese: Flupirtinmaleat Winthrop 400 mg Retardtabletten pillola li terħi l-mediċina bil-mod
English: Midas Pharma GmbH Rheinstrasse, 49 55218 Ingelheim Germany
Maltese: Midas Pharma GmbH Rheinstrasse, 49
English: MEDA Pharma GmbH & Co. KG Benzstr.
Maltese: MEDA Pharma GmbH & Co.
English: Katadolon 100 mg hard capsules
Maltese: Katadolon 100 mg iebsa kapsulas
English: Katadolon S long prolonged release tablet
Maltese: Katadolon S long pillola li terħi l-mediċina bil-mod
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, detenturi tal-awtorizzazzjoni għat-tqegħidfis-suq fl-Istati Membri
English: 3542 DR Utrecht The Netherlands
Maltese: Teva Pharma B.V. Computerweg 10 3542 DR Utrecht L-Olanda
English: Slovak Republic Zentiva k.s.
Maltese: Ir-Repubblika Ċeka
English: Further information can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016 EMA/358774/2016 EMEA/H/C/003978
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Mejju 2016 EMA/358774/2016 EMEA/H/C/003978
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus) EMA/358774/2016
Maltese: (sirolimus) EMA/358774/2016
English: What is Opsiria?
Maltese: X'inhu Opsiria?
English: Opsiria is a medicine that contains the active substance sirolimus.
Maltese: Opsiria huwa mediċina li fiha s-sustanza attiva sirolimus.
English: Opsiria was investigated in one main study in 347 patients with non-infectious uveitis.
Maltese: Opsiria kien investigat fi studju prinċipali wieħed fi 347 pazjent b'uvejtis mhux infettiva.
English: The active substance in Opsiria, sirolimus, is expected to work by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR).
Maltese: Is-sustanza attiva f'Opsiria, sirolimus, hija mistennija li taħdem billi timblokka enzima msejħa "mira ta' rapamajsin mammaljana" (mTOR, mammalian target of rapamycin).
English: The application was withdrawn after that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula listi ta' mistoqsijiet.
English: On 20 May 2016, Santen Oy officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opsiria, for the treatment of non-infectious uveitis.
Maltese: Fl-20 ta' Mejju 2016, Santen Oy għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal Opsiria, għall-kura ta' uvejtis mhux infettiva.
English: Opsiria was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 30 August 2011 for the treatment of chronic non-infectious uveitis.
Maltese: Opsiria kien ikklassifikat bħala "mediċina orfni" (mediċina li tintuża f'mard rari) fit-30 ta' Awwissu 2011 għall-kura ta' uvejtis mhux infettiva kronika.
English: Opsiria was expected to be used for the treatment of non-infectious uveitis (inflammation of the uvea, the middle layer of the eye) in adults.
Maltese: Opsiria kien mistenni li jintuża għall-kura ta' uvejtis mhux infettiva (infjammazzjoni tal-uvea, is-saff tan-nofs tal-għajn) fl-adulti.
English: How is Opsiria expected to work?
Maltese: Għalxiex kien mistenni li jintuża Opsiria?
English: Since mTOR is involved in the activation and proliferation of T lymphocytes (white blood cells that play a role in inflammation), sirolimus is expected to reduce the inflammation in chronic non-infectious uveitis.
Maltese: Peress li l-mTOR hija involuta flattivazzjoni u fil-proliferazzjoni ta' limfoċiti T (ċelloli tad-demm bojod li għandhom rwol flinfjammazzjoni), sirolimus hija mistennija li tnaqqas l-infjammazzjoni f'uvejtis mhux infettiva kronika.
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Opsiria (sirolimus)
English: In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Maltese: Barra minn hekk, il-Kumitat ma kienx żgur mill-metodu propost ta' sterilizzazzjoni tal-mediċina.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Opsiria could not have been approved for the treatment of non-infectious uveitis.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Opsiria ma setax jiġi approvat għall-kura ta' uvejtis mhux infettiva.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Opsiria.
Maltese: Id-dejta mill-istudju kliniku ma kinetx suffiċjenti biex turi lbenefiċċju ta' Opsiria, partikolarment f'pazjenti Ewropej.
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis.
Maltese: IrRapporteur kien Dr Karl Broich u l-Ko-Rapporteur(s) kien Dr Pierre Demolis.
English: London, 25 October 2007 EMEA/CHMP/350251/2007
Maltese: Londra, 25 ta' Ottubru 2007 EMEA/CHMP/350251/2007
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI SKOND L-ARTIKOLU 29(4)1 REFERENZA GĦAL Xeomin Denominazzjoni Komuni Internazzjonali (INN- Internatinal Non-proprietary Name ): Clostridium botulinum neurotoxin tip A
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: Dan huwa dwar l-Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendat.
English: The Reference Member State was Germany and the Concerned Member States were Austria, Denmark, Spain, Finland, France, Italy, Luxembourg, Norway, Poland, Portugal, Sweden and United Kingdom.
Maltese: L-Istat Membru ta' Referenza kien il-Ġermanja u l-Istati Membri Konċernati kienu l-Awstrija, id-Danimarka, Spanja, il-Finlandja, Franza, l-Italja, il-Lussemburgu, in-Norveġja, il-Polonja, il-Portugall, l-Iżvezja u rRenju Unit.
English: Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Maltese: Xeomin, 100 unitajiet fi trab LD50 għal soluzzjoni f'injezzjoni, huwa indikat għal ġestjoni ta' symptomatika ta' blepharospasm u dystonia ċervikali ta' forma predominantement rotazzjonali (spasmodic torticollis) f'adulti.
English: The Marketing Authorisation Holder provided written explanations on 25 May 2007.
Maltese: Il-Pussessur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq ta' spjegazzjonijiet bil-miktub fil-25 ta' Mejju 2007.
English: Merz Pharmaceuticals GmbH submitted applications for mutual recognition of Xeomin, 100 LD50 units powder for solution for injection, on the basis of the marketing authorisation granted by Germany on 31 May 2005.
Maltese: GmbH issottomettiet applikazzjonijiet għar-rikonoxximent reċiproku ta' Xeomin, 100 unitajiet fi trab LD50 għal soluzzjoni f'injezzjoni, abbażi ta' awtorizzazzjoni għat-tqegħid fis-suq millĠermanja fil-31 ta' Mejju 2005.
English: Germany referred the reasons for disagreement to the EMEA on 29 March 2007.
Maltese: Il-Ġermanja irreferiet għarraġunijiet ta' nuqqas ta' qbil lill-EMEA fid-29 ta' Marzu 2007.
English: The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Maltese: Il-proċedura ta' l-arbitraġġ bdiet fis-26 ta' Lulju 2007 permezz ta' l-adozzjoni ta' lista ta' domandi.
English: During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Waqt il-laqgħa tiegħu tas-16-19 ta' Lulju ta' l-2007, il-CHMP, fid-dawl tat-tagħrif sottomess kollu u fid-dawl tad-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li l-bilanċ bejn il-benefiċċji u r-riskji kien favorevoli għal Xeomin, li l-objezzjonijiet imqajma ma għandhomx jimpedixxu l-għoti ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom jiġu emendati.
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.
Maltese: It-tuberkulożi hija infezzjoni kkawżata mill-batterju Mycobacterium tuberculosis.
English: The full EPAR and risk management plan summary for Sirturo 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: The summary of the opinion of the Committee for Orphan Medicinal Products for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The medicine is available as 100 mg tablets.
Maltese: Il-mediċina tiġi bħala pilloli tal-100 mg.
English: The study showed that after 24 weeks, 79% of the patients given Sirturo (52 out of 66 patients) tested negative for the bacteria in the sputum (phlegm) compared with 58% of patients given placebo (38 out of 66 patients).
Maltese: L-istudju wera li wara 24 ġimgħa, 79 % tal-pazjenti li ngħataw Sirturo (52 minn 66 pazjent) ittestjati negattivi għall-batterija fl-ispuntum (materja) meta mqabbel ma' 58 % talpazjenti li ngħataw plaċebo (38 minn 66 pazjent).
English: Sirturo is a tuberculosis medicine that contains the active substance bedaquiline.
Maltese: Sirturo huwa mediċina kontra t-tuberkulożi li fiha s-sustanza attiva bedaquiline.
English: This is a summary of the European public assessment report (EPAR) for Sirturo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Sirturo.
English: Sirturo has been given ‘conditional approval'.
Maltese: Sirturo ngħata ‘approvazzjoni kundizzjonali'.
English: Other information about Sirturo
Maltese: Informazzjoni oħra dwar Sirturo
English: Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Sirturo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005.
Maltese: Peress li n-numru ta' pazjenti bit-tuberkolożi huwa baxx fl-UE, il-marda titqies ‘rari', u Sirturo ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fis-26 ta' Awwissu 2005.
English: Why is Sirturo approved?
Maltese: Għalxiex ġie approvat Sirturo?
English: What are the risks associated with Sirturo?
Maltese: X'inhuma r-riskji assoċjati ma' Sirturo?
English: Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines).
Maltese: Sirturo jintuża flimkien ma' mediċini kontra t-tuberkulożi oħrajn f'adulti bit-tuberkulożi li tkun qiegħda taffettwa l-pulmun u li hija reżistenti għal ħafna mediċini (reżistenti għallinqas għal isoniazid u rifampicin, żewġ mediċini kontra ttuberkulożi standard).
English: The most common side effects with Sirturo (which may affect more than 1 in 10 people) are headache, dizziness, nausea (feeling sick), vomiting, and arthralgia (joint pain).
Maltese: L-effetti sekondarji l-aktar komuni b'Sirturo (li jistgħu jaffettwaw lil aktar minn persuna 1 minn kull 10) huma uġigħ ta' ras, sturdament, dardir (tħossok ma tiflaħx), rimettar u artralġja (uġigħ fil-ġogi).
English: With regard to safety, the side effects reported in the Sirturo group in the main study were not markedly different from those in the placebo group, though there were higher levels of liver enzymes and some reports of alterations in the heart's electrical activity (known as prolonged QT interval).
Maltese: Fir-rigward tas-sigurtà, l-effetti sekondarji rrapportati fil-grupp ta' Sirturo fl-istudju prinċipali ma kinux sostanzjalment differenti minn dawk fil-grupp tal-plaċebo, għalkemm kien hemm livelli ogħla ta' enzimi tal-fwied u xi rapporti ta' alterazzjonijiet fl-attività elettrika tal-qalb (magħrufa bħala intervall QT imtawwal).
English: Since Sirturo has been granted a conditional approval, the company that markets Sirturo will provide additional data on the medicine's benefits and safety when used with different combinations of medicines.
Maltese: Peress li Sirturo ngħata approvazzjoni kundizzjonali, il-kumpanija li tikkummerċjalizza Sirturo ser tipprovdi dejta addizzjonali dwar il-benefiċċji u s-sigurtà tal-mediċina meta tintuża flimkien ma' mediċini differenti.
English: What information is still awaited for Sirturo?
Maltese: Liema informazzjoni għadha mistennija għal Sirturo?
English: The company will also provide longer term safety data on the medicine.
Maltese: Il-kumpanija ser tipprovdi wkoll dejta ta' sigurtà fit-tul dwar il-mediċina.
English: In a main study in adults with multi-drug resistant tuberculosis affecting the lung, Sirturo was compared with placebo (a dummy treatment) when added to combination treatment with other standard tuberculosis medicines.
Maltese: Fi studju ewlieni fl-adulti, b'tuberkolożi reżistenti għal ħafna mediċini li taffettwa l-pulmuni, Sirturo tqabbel ma' plaċebo (kura finta) meta jiġi miżjud ma' kura ta' kombinazzjoni ma' mediċini oħra kontra t-tuberkulożi standard.
English: The active substance in Sirturo, bedaquiline, works by specifically blocking an enzyme inside the M. tuberculosis bacteria called ATP synthase, which the bacteria need to generate energy.
Maltese: Is-sustanza attiva f'Sirturo, bedaquiline, taħdem billi timblokka b'mod speċifiku enzima ġewwa lbatterja M. tuberculosis imsejħa snythase ATP, li l-batterji għandhom bżonnha biex jiġġeneraw lenerġija.
English: A risk management plan has been developed to ensure that Sirturo is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Sirturo jintuża bl-aktar mod sigur possibbli.
English: For practical information about using Sirturo, patients should read the package leaflet or contact their doctor or pharmacist.
Maltese: Kien hemm numru ogħla ta' mwiet irrapportati fil-grupp ta' Sirturo.
English: The recommended dose is 4 tablets once a day for the first 2 weeks and then 2 tablets taken 3 times a week for the next 22 weeks.
Maltese: Id-doża rrakkomandata hija 4 pilloli darba kuljum għall-ewwel ġimagħtejn u mbagħad 2 pilloli li jittieħdu 3 darbiet fil-ġimgħa għat-22 ġimgħa li jmiss.
English: The average time it took to clear the bacteria from the sputum was also shorter for patients in the Sirturo group than for those in the placebo group (83 days versus 125 days).
Maltese: Il-ħin medju li kien meħtieġ biex il-batterji jitneħħew mill-isputum kien ukoll iqsar għal pazjenti fil-grupp ta' Sirturo minn dak fil-grupp ta' plaċebo (83 jum meta mqabbel ma' 125 jum).
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mnejn għandu jingħata, applikanti/detenturi tal-awtorizzazzjoni għattqegħid fis-suq fl-Istati Membri
English: The injection is given into a vein over several minutes.
Maltese: L-injezzjoni tingħata ġol-vina matul diversi minuti.
English: Further information on Elocta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Elocta.
Maltese: ema.europa.eu/medicines/human/EPAR/Elocta.
English: This summary was last updated in 10-2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2018.
English: Elocta received a marketing authorisation valid throughout the EU on 19 November 2015.
Maltese: Elocta ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Novembru 2015.
English: It contains the active substance efmoroctocog alfa.
Maltese: Fih is-sustanza attiva efmoroctocog alfa.
English: Other information about Elocta
Maltese: Informazzjoni oħra dwar Elocta
English: Hypersensitivity (allergic) reactions are seen rarely with Elocta and these include: swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the injection site, chills, flushing, itching over the whole body, headache, low blood pressure, lethargy, nausea, restlessness, and a fast heartbeat.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġika) jintwerew b'mod rari b'Elocta u dawn jinkludu: nefħa fil-wiċċ, raxx, urtikarja, tagħfis fis-sider u diffikultà biex tieħu nifs, ħruq u tingiż fil-post fejn ingħatat linjezzjoni, sirda, fwawar, ħakk mal-ġisem kollu, uġigħ ta' ras, pressjoni tad-demm baxxa, letarġija, dardir, irrekwitezza, u tħabbit mgħaġġel tal-qalb.
English: In a study of 165 adult patients with haemophilia A, patients who were given Elocta as a tailored preventive treatment had around 3 bleeding episodes a year, which compares with 37 episodes a year in patients not given preventive treatment.
Maltese: Fi studju ta' 165 pazjent adult bl-emofilja A, il-pazjenti li ngħataw Elocta bħala kura preventiva mfassla apposta kellhom madwar 3 episodji ta' fsada fis-sena, mqabbla ma' 37 episodju fis-sena f'pazjenti li ma ngħatawx kura preventiva.
English: In a study in 69 children, Elocta was similarly effective: 2 bleeding episodes occurred per year on average and 81% of bleeding episodes resolved with only one injection.
Maltese: Fi studju fuq 69 tifel u tifla, Elocta kien effikaċi b'mod simili: bħala medja seħħew 2 episodji ta' fsada fis-sena u 81 % tal-episodji ta' fsada ġew riżolti b'injezzjoni waħda biss.
English: What are the risks associated with Elocta?
Maltese: X'inhuma r-riskji assoċjati ma' Elocta?
English: The active substance in Elocta, efmoroctocog alfa, works in the body in the same way as human factor VIII.
Maltese: Is-sustanza attiva f'Elocta, efmoroctocog alfa, taħdem fil-ġisem bl-istess mod bħall-fattur VIII uman.
English: As for all medicines, data on the use of Elocta are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Elocta hija ssorveljata kontinwament.
English: Elocta is available as a powder and solvent used to make a solution for injection.
Maltese: Elocta jiġi bħala trab u solvent li jintuża biex tiġi prodotta soluzzjoni għall-injezzjoni.
English: There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Hemm ukoll riskju li bil-mediċini ta' fattur VIII ċerti pazjenti jiżviluppaw inibituri (antikorpi) kontra fattur VIII, u dan jikkawża lill-mediċina biex tieqaf taħdem u jirriżulta f'telf tal-kontroll tal-fsada.
English: In addition, when bleeding did occur, Elocta treatment was rated as ‘excellent' or ‘good' in more than 78% of cases, with 87% of bleeding episodes resolving with only one injection.
Maltese: Barra minn hekk, meta seħħet il-fsada, il-kura b'Elocta kienet ikklassifikata bħala ‘eċċellenti' jew ‘tajba' f'aktar minn 78 % tal-każijiet, b'87 % tal-episodji ta' fsada riżolti b'injezzjoni waħda biss.
English: Why is Elocta authorised in the EU?
Maltese: Għaliex Elocta huwa awtorizzat fl-UE?