FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant provided data supporting the pharmacokinetic bridging strategy and demonstrating that fentanyl delivery from Rapinyl provides effective pain relief in the target population.
Maltese: L-applikant ipprovda informazzjoni li ssostni l-istrateġija ta' bridging farmakokinetiku u wera li t-twassil ta' fentanyl minn Rapinyl jipprovdi serħan reali mill-uġigħ fil-popolazzjoni fil-mira.
English: The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State:
Maltese: L-applikant jimpenja ruħu li jipprovdi l-informazzjoni segwenti lill-Awtorità Nazzjonali Kompetenti ta' l-Istat Membru ta' Referenza:
English: The CHMP considered that the information provided was sufficient for concluding that repeat dose data following Actiq and Rapinyl are similar, and the dose proportionalilty between Actiq and Rapinyl was considered as established through the single dose data, pending further clinical safety and efficacy data.
Maltese: Is-CHMP ikkunsidra li l-informazzjoni pprovduta kienet suffiċjenti biex wieħed jikkonkludi li ttagħrif dwar dożi ripetuti ta' Actiq u Rapinyl kien simili, u li l-proporzjonalità tad-doża bejn Actiq u Rapinyl kienet ikkunsidrata bħala stabbilita mill-informazzjoni dwar doża waħda, sakemm toħroġ aktar informazzjoni dwar l-effikaċja u s-sigurtà klinika.
English: Marketing authorisation holder: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ [Biex jimtela mill-pajjiż partikolari]
English: Rapinyl 100 µg sublingual tablets
Maltese: Rapinyl 100 mikrogramma pilloli għal taħt l-ilsien
English: Dose titration needs to be approached with particular care and patients observed carefully for signs of fentanyl toxicity (see section 4.4).
Maltese: It-titrazzjoni tad-doża trid issir b'attenzjoni partikolari u l-pazjenti għandhom jiġu osservati b'attenzjoni għal sinjali ta' tossiċità minn fentanyl (ara sezzjoni 4.4).
English: Rapinyl 400 µg sublingual tablets
Maltese: Rapinyl 400 µg pilloli għal taħt l-ilsien
English: Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed child. Fentanyl should only be used by breast-feeding women if the benefits clearly outweigh the potential risks for both mother and child.
Maltese: Fentanyl, bħal fil-każ ta' l-agonisti riċettaturi opjojdi-µ kollha, jipproduċi dipressjoni respiratorja li tiddependi mid-doża mogħtija.
English: The CHMP considered that while there are no reasons to suspect that individualised dose titration would not work for the majority of the patients, the CHMP noted that the highest dose was not studied and considered the study size (n=8) to be too small to draw any reliable conclusions due to the limited number of observations and the absence of statistical analysis of the available data.
Maltese: Is-CHMP ħass li filwaqt li ma kien hemm ebda raġuni biex wieħed jissuspetta li t-titrazzjoni personalizzata tad-doża ma kinitx ser taħdem għall-maġġoranza tal-pazjenti, huwa nnota li l-akbar doża ma kinitx ġiet studjata u qies id-daqs ta' l-istudju (n=8) bħala żgħir wisq biex wieħed ikun jista' joħroġ xi konklużjonijiet affidabbli minħabba n-numru limitat ta' osservazzjonijiet u n-nuqqas ta' analiżi statistika mill-informazzjoni disponibbli.
English: A range of dose strengths allow individualised upward titration from the recommended starting dose to a dose that provides analgesia with acceptable side-effects.
Maltese: Ilvarjetà ta' dożaġġi disponibbli tippermetti titrazzjoni personalizzata li tiżdied mid-doża inizjali rakkomandata għal doża li tipprovdi serħan mill-uġigħ b'effetti sekondarji aċċettabbli.
English: Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain.
Maltese: Rapinyl huwa maħsub għat-trattament ta' wġigħ episodiku (breakthrough) qawwi filpazjenti ttrattati bl-oppjojdi għall-uġigħ kroniku tal-kanċer.
English: In addition, the oral cavity was inspected by the clinician or nurse 15-20 minutes after treatment to check for local irritation, no abnormal results were identified and the tablets were well tolerated after both single and repeat doses.
Maltese: Barra minn hekk, il-kavità orali ġiet eżaminata mit-tabib jew l-infermier 15-20 minuta wara t-trattament biex jikkontrollow jekk hemmx irritazzjoni orali, ma kien identifikat ebda riżutat anomalu u l-pilloli kienu tollerati sewwa kemm wara doża waħda kif ukoll wara dożi ripetuti.
English: The symptoms of fentanyl overdose are an extension of its pharmacological actions, the most serious effect being respiratory depression, which may lead to respiratory arrest.
Maltese: Is-sintomi ta' doża eċċessiva ta' fentanyl huma estensjoni ta' l-azzjonijiet farmakoloġiċi tiegħu, bl-aktar effett serju jkun dipressjoni respiratorja li jista' jwassal għal arrest respiratorju.
English: EU (MA) Number
Maltese: Numru tal-UE (MA) Isem (ivvintat)
English: Pack size
Maltese: Il-Pakkett Li Jmiss Mal-Prodott
English: Annex I List of the names, pharmaceutical form, 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, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl
English: Kampenringweg 45 D-E Gouda Netherlands
Maltese: D-E Gouda Netherlands
English: Netherlands Sanofi-Aventis Netherlands B.V.
Maltese: Sanofi-Aventis
English: This overview was last updated in 05-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi 05-2019.
English: Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex.
Maltese: ema.europa.eu/medicines/human/EPAR/imvanex.
English: It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara', which is related to the smallpox virus.
Maltese: Fiha forma ħajja modifikata talvirus vaccinia magħruf bħala ‘vaccinia Ankara', li huwa relatat mal-virus tal-ġidri.
English: Other information about Imvanex
Maltese: Informazzjoni oħra dwar Imvanex
English: Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013.
Maltese: Imvanex irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fil-31 ta' Lulju 2013.
English: Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977.
Maltese: Il-ġidri ġiet uffiċjalment eradikata fl-1980 bl-aħħar każ magħruf tal-marda jseħħ fl-1977.
English: The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching).
Maltese: L-effetti sekondarji l-aktar komuni b'Imvanex (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma uġigħ ta' ras, dardir, mijalġja (uġigħ fil-muskoli), għeja u reazzjonijiet fis-sit tal-injezzjoni (uġigħ, ħmura, nefħa, ebusija u ħakk).
English: The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past.
Maltese: Fl-istudji ħadu sehem aktar minn 2,000 adult, inklużi pazjenti bl-HIV u b'dermatite atopika (kundizzjoni tal-ġilda bil-ħakk ikkawżata minn sistema immuni attiva żżejjed) u persuni li fil-passat kienu ġew imlaqqma kontra l-ġidri.
English: Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin.
Maltese: Imvanex m'għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għas-sustanza attiva jew għal xi sustanza oħra li tinsab f'livelli traċċa, bħall-proteini tat-tiġieġ, benzonase u gentamicin.
English: Imvanex has been authorised under ‘exceptional circumstances'.
Maltese: Imvanex ġie awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: How is Imvanex used?
Maltese: Imvanex?
English: Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future.
Maltese: Minħabba li Imvanex ġie awtorizzat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed Imvanex fis-suq se tipprovdi data dwar il-benefiċċji u r-riskji tat-tilqim minn studji ta' osservazzjoni fil-pazjenti li jingħataw it-tilqim u jekk qatt ikun hemm tifqigħa tal-marda fil-futur.
English: What are the risks associated with Imvanex?
Maltese: X'inhuma r-riskji assoċjati ma' Imvanex?
English: Imvanex is a vaccine used to protect against smallpox in adults.
Maltese: Imvanex huwa tilqima li tintuża għall-prevenzjoni tal-ġidri fl-adulti.
English: However, the duration of protection is not known.
Maltese: Għadu mhux magħruf kemm se ddum il-protezzjoni.
English: The vaccinia virus in Imvanex cannot replicate in human cells and hence is less likely to cause side effects than conventional smallpox vaccines.
Maltese: Il-virus vaccinia f'Imvanex ma jistax jirreplika fiċ-ċelluli tal-bniedem u għalhekk huwa anqas probabbli li jikkawża effetti sekondarji minn tilqim konvenzjonali tal-ġidri.
English: Imvanex was shown in studies to be effective at triggering the production of antibodies to a level expected to provide protection against smallpox.
Maltese: Imvanex intwera fl-istudji li huwa effettiv fl-attivazzjoni tal-produzzjoni ta' antikorpi għal livell mistenni li jipprovdi protezzjoni kontra l-ġidri.
English: A subsequent study in 433 people who had not been vaccinated before found that the level of protective antibodies after vaccination with Imvanex was at least as high as with a conventional smallpox vaccine.
Maltese: Studju sussegwenti f'433 persuna li ma ġewx imlaqqma qabel sab li l-livell tal-antikorpi protettivi wara t-tilqim b'Imvanex kien mill-inqas għoli daqs b'vaċċin konvenzjonali tal-ġidri.
English: Imvanex (live modified vaccinia ankara virus)
Maltese: Għaliex Imvanex ġie awtorizzat fl-UE?
English: What information is still awaited for Imvanex?
Maltese: Liema informazzjoni għadha mistennija għal Imvanex?
English: Because of its similarity to the smallpox virus, antibodies produced against this virus are also expected to protect against smallpox.
Maltese: Minħabba s-similaritajiet tiegħu mal-virus tal-ġidri, l-antikorpi prodotti kontra dan il-virus huma mistennija wkoll jipproteġu kontra lġidri.
English: If a booster dose is necessary for those who have been vaccinated against smallpox in the past, a single 0.5 ml dose should be given except for patients with a weakened immune system (the body's natural defences) who should receive two booster doses, with the second dose given at least 28 days after the first.
Maltese: Jekk doża booster titqies li hija neċessarja għal dawk li fil-passat tlaqqmu kontra l-ġidri, għandha tingħata doża unika ta' 0.5 ml ħlief għal pazjenti b'sistema immuni mdgħajfa (id-difiżi naturali talġisem) li għandhom jirċievu żewġ dożi booster, bit-tieni doża tingħata mhux inqas minn 28 ġurnata wara l-ewwel waħda.
English: Two of the studies specifically looked at the effectiveness of Imvanex as a booster.
Maltese: Tnejn mill-istudji speċifikament eżaminaw leffikaċja ta' Imvanex bħala booster.
English: Imvanex contains a modified form of the vaccinia virus called vaccinia Ankara, which does not cause disease in humans and cannot replicate (reproduce) in human cells.
Maltese: Imvanex fih forma modifikata tal-virus vaccinia magħruf bħala vaccinia Ankara, li ma jikkawżax mard fil-bnedmin u ma jistax jirreplika (jirriproduċi) fiċ-ċelluli tal-bniedem.
English: As for all medicines, data on the use of Imvanex are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Imvanex hija ssorveljata kontinwament.
English: Imvanex is given by injection under the skin, preferably in the upper arm. People who have not been previously vaccinated against smallpox should receive two 0.5 ml doses, with the second dose given at least 28 days after the first.
Maltese: Persuni li ma jkunux ġew imlaqqma qabel kontra l-ġidri għandhom jirċievu żewġ dożi ta' 0.5 ml, bittieni doża tingħata mhux inqas minn 28 ġurnata wara l-ewwel waħda.
English: The European Medicines Agency considered that Imvanex is effective at triggering the production of antibodies against smallpox to a level that provides protection at least as high as that from conventional smallpox vaccines.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkunsidrat li Imvanex huwa effettiv fl-attivazzjoni tal-produzzjoni ta' antikorpi kontra l-ġidri għal livell li jipprovdi protezzjoni tal-inqas daqs dik minn vaċċini konvenzjonali tal-ġidri.
English: Vaccines containing vaccinia viruses were effective in the campaign to eradicate smallpox.
Maltese: Tilqim li fih virusijiet tal-vaccinia ntuża b'mod effettiv fil-kampanja biex tinqered il-ġidri.
English: When the person comes into contact again 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 terġa' tiġi esposta għal dan il-virus jew għal virus simili, dawn l-antikorpi flimkien ma' komponenti oħra tas-sistema immuni jkunu kapaċi joqtlu l-virusijiet u jgħinu biex jipproteġu kontra l-marda.
English: When a person is given the vaccine, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata t-tilqima, is-sistema immuni tagħraf il-virus fit-tilqima bħala ‘barrani' u tagħmel antikorpi kontrih.
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Maltese: • Il-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE ntweriet, abbażi ta' data rilevanti, skont ir-rekwiżiti tal-Artikolu 10 tad-Direttiva 2001/83/KE (eż. studju ta' bijoekwivalenza mwettaq fir-rigward tal-prodott mediċinali ta' referenza tal-UE).
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holder(s)
Maltese: Sabiex titneħħa s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq imsemmija fl-anness IB, lawtoritajiet kompetenti tal-Istati Membri tal-UE għandhom jiżguraw li l-kundizzjoni t'hawn taħt ġiet issodisfata mid-detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq
English: Condition for lifting the suspension of the marketing authorisations
Maltese: Anness
English: It is available as tablets (15, 30 and 45 mg).
Maltese: Jiġi f'għamla ta' pilloli (15, 30 u 45 mg).
English: The full EPAR for Sepioglin 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: Sepioglin is a ‘generic medicine'.
Maltese: Sepioglin huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sepioglin on 9 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sepioglin Fid-9 ta' Marzu 2012.
English: The recommended starting dose of Sepioglin is 15 or 30 mg once a day.
Maltese: Id-doża inizjali rakkomandata ta' Sepioglin hija 15 jew 30 mg darba kuljum.
English: EPAR summary for the public pioglitazone
Maltese: Sommarju tal-EPAR għall-pubbliku pijoglitażonu
English: This is a summary of the European public assessment report (EPAR) for Sepioglin.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sepioglin.
English: This summary was last updated in 10-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f':10-2011.
English: The CHMP concluded that, in accordance with EU requirements, Sepioglin has been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Sepioglin għandu kwalità komparabbli u li huwa bijoekwivalenti għal Actos.
English: What are the benefits and risks of Sepioglin?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Sepioglin?
English: Sepioglin is a medicine that contains the active substance pioglitazone.
Maltese: Sepioglin huwa mediċina li fiha s-sustanza attiva pijoglitażonu.
English: Why has Sepioglin been approved?
Maltese: Għaliex ġie approvat Sepioglin?
English: The active substance in Sepioglin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva fi Sepioglin, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jibda jagħmel użu aħjar mill-insulina li jipproduċi.
English: This means that Sepioglin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Sepioglin huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: Because Sepioglin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Sepioglin huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Sepioglin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Sepioglin huwa mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Actos.
English: What is Sepioglin?
Maltese: Kif jaħdem Sepioglin?
English: Sepioglin can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Maltese: Sepioglin jista' jintuża wkoll kemm mal-metaformina u kemm mas-sulfonilurea fuq pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti minkejja l-għoti ta' terapija doppja mill-ħalq (‘terapija trippla').
English: Sepioglin can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Maltese: Sepioglin jista' jintuża wkoll flimkien mal-metformina f'pazjenti li ma jkunux jistgħu jiġu kkontrollati b'mod sodisfaċenti bil-metformin biss, jew mas-sulfonilurea (tip ieħor ta' mediċina antidijabetika) meta l-metformina ma tkunx tista' tintuża (‘terapija doppja').
English: How has Sepioglin been studied?
Maltese: Kif ġie studjat Sepioglin?
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Actos, il-benefiċċji huma akbar mir-riskji identifikati.
English: Sepioglin should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Maltese: Sepioglin m'għandux jintuża fuq pazjenti bid-dijaliżi (teknika tat-tisfija tad-demm użata f'nies b'mard fil-kliewi).
English: Sepioglin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Sepioglin jintuża għall-kura tad-dijabete tat-tip 2 f'adulti (minn 18-il sena 'l fuq), b'mod partikolari dawk b'piż eċċessiv.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Maltese: Jista' jenħtieġ li din iddoża tiżdied wara ġimgħa jew ġimgħatejn sa 45 mg darba kuljum jekk ikun meħtieġ kontroll aħjar fuq il-glukożju fid-demm (zokkor).
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar tagħrif dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet-u-tweġibiet hawnhekk.
English: Other information about Sepioglin
Maltese: Għalxiex jintuża Sepioglin?
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika
English: MA (EU) Number (Invented) name
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: 1 pre-filled pen + 1 pre-filled pen
Maltese: Pinna 1 mimlija għal-lest + pinna 1 mimlija għal-lest
English: nonacog alfa
Maltese: nonakog alfa
English: The full EPAR for BeneFIX 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: In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX.
Maltese: F'pazjenti li kienu diġà rċevew kura, 82% mis-693 episodju ta' fsada kkurat ġew riżolti wara infużjoni unika ta' BeneFIX.
English: This summary was last updated in 09-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'09-2015.
English: They include angioedema (swelling of the face and limbs), burning and stinging at the injection site, chills, flushing, urticaria (itchy rash), headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (fast heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Maltese: Dawn jinkludu anġjodema (nefħa fil-wiċċ u fil-ġogi), ħruq u tingiż fis-sit talinjezzjoni, tertir, ħmura, urtikarja (raxx bil-ħakk), uġigħ ta' ras, ħorriqija, ipotensjoni (pressjoni taddemm baxxa), ħedla, nawżja (tħossok ma tiflaħx), nuqqas ta' sabar, takikardja (taħbit tal-qalb mgħaġġel), għafis tas-sider, tnemnim, remettar u tħarħir ta' nifs.
English: BeneFIX is a medicine that contains the active substance nonacog alfa.
Maltese: BeneFIX huwa mediċina li fiha s-sustanza attiva nonakog alfa.
English: This document is a summary of the European Public Assessment Report (EPAR) for BeneFIX.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal BeneFIX.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal BeneFIX valida fl-Unjoni Ewropea kollha fis-27 ta' Awwissu 1997.
English: Out of 972 infusions, 84% were rated as bringing about ‘good' or ‘excellent' responses.
Maltese: Minn 972 infużjoni, 84% ġew stmati li kellhom rispons “tajjeb” jew “eċċellenti”.
English: Other information about BeneFIX
Maltese: Aktar informazzjoni dwar BeneFIX
English: The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs.
Maltese: In-nuqqas tal-fattur IX jikkawża problemi ta' tagħqid tad-demm, bħal fsada fil-ġogi, fil-muskoli u fl-organi interni.
English: Nonacog alfa is not extracted from human blood but produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce human coagulation factor IX.
Maltese: In-nonakog alfa mhijiex estratta mid-demm tal-bniedem iżda tiġi prodotta permezz ta' metodu magħruf bħala 'teknoloġija tad-DNA rikombinanti': hija magħmula minn ċelloli li jkunu rċevew ġene (DNA), li tagħmilhom kapaċi jipproduċu l-fattur IX tal-bniedem tal-koagulazzjoni.
English: It corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Maltese: Huwa jsewwi d-defiċjenza tal-fattur IX u jagħti kontroll temporanju fuq id-disturb tal-fsada.