FrancophonIA/ELRC3.0 huggingface dataset:
English: The main clinical study of Aflunov involved over 4,000 adults.
Maltese: Fl-istudju kliniku ewlieni dwar Aflunov ħadu sehem iktar minn 4,000 adult.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)
Maltese: MISTOQSIJA U TWEĠIBA DWAR L-IRTIRAR TA' L-APPLIKAZZJONI GĦAT-TQEGĦID FIS-SUQ għal AFLUNOV Isem komuni: Vaċċin prepandemiku ta' l-influwenza (H5N1) (antiġen tal-wiċċ, inattivat, imsaħħaħ) (A/VietNam/1194/2004)
English: Aflunov is a vaccine.
Maltese: Aflunov huwa vaċċin.
English: It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/VietNam/1194/2004.
Maltese: Jikkonsisti minn sospensjoni għall-injezzjoni li fiha xi partijiet (membrani ta' barra) tar-razza tal-vajrus ta' l-influwenza magħrufa bħala A/VietNam/1194/2004.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun tat tweġibiet għall-mistoqsijiet, is-CHMP janalizzahom u jista', qabel ma' jagħti opinjoni, jistaqsi xi mistoqsijiet oħra li jista' jkollu fil-180 jum.
English: Aflunov also contains an ‘adjuvant' (a compound containing oil), which is expected to stimulate a better response.
Maltese: Aflunov fih ukoll ‘adjuvant' (kompost li jkun fih żejt), li hu mistenni jistimula rispons aħjar.
English: Aflunov was expected to be used in adults and the elderly to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Maltese: Aflunov kien mistenni li jintuża għall-adulti u l-anzjani biex jipproteġihom kontra influwenza kkawżata mir-razza(tip) H5N1 tal-vajrus ta' l-influwenza A.
English: This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Maltese: Dan huwa tip speċjali ta' vaċċin li huwa maħsub biex jipproteġi kontra tip ta' influwenza li tista' tikkawża pandemija fil-ġejjieni.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Abbażi ta' l-analiżi taddokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-120 jum, u din tintbagħat lillkumpanija.
English: Aflunov was expected to provide protection against this strain, so that it could be used before or during a flu pandemic.
Maltese: Aflunov kien mistenni li jagħti protezzjoni kontra dan it-tip, u għalhekk jista' jintuża qabel jew waqt pandemija ta' l-influwenza.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Maltese: Abbażi ta' l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien l-irtirar, is-CHMP kellu xi tħassib u kien tal-fehma proviżorja li Aflunov ma setax jiġi approvat għallprevenzjoni ta' l-influwenza avjarja H5N1.
English: What documentation did the company present to support its application to the CHMP?
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija għas-sostenn ta' l-applikazzjoni tagħha lis-CHMP?
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Aflunov?
Maltese: Għalxiex kien mistenni li jintuża Aflunov?
English: The effects of Aflunov were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Aflunov għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Maltese: L-esperti tas-saħħa huma mħassba billi l-pandemija ta' l-influwenza li jmiss tista' tkun ikkawżata mit-tip H5N1 tal-vajrus.
English: When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-partijiet talvajrus ta' l-influwenza fil-vaċċin bħala ‘barranin' u tagħmel antikorpi kontrihom.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP ivvaluta t-tweġibiet millkumpanija għal-lista ta' mistoqsijiet, kien għad hemm xi kwistjonijiet pendenti.
English: The comparator vaccine contained different strains of seasonal flu virus, but the rest of the components were the same as in Aflunov.
Maltese: vaċċin simili kontra l-influwenza staġjonali.
English: It compared Aflunov's safety and its ability to stimulate the production of antibodies (‘immunogenicity') with those of a similar vaccine against seasonal flu.
Maltese: Is-sistema immunitarja tkun tista' tipproduċi antikorpi iktar malajr meta tkun esposta għal vajrus ta' l-influwenza ta' l-istess tip.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Maltese: Pandemija ta' l-influwenza sseħħ meta jitfaċċa tip ġdid ta' vajrus ta' l-influwenza li jkun jista' jinfirex malajr minn persuna għal oħra għax in-nies ma jkollhom l-ebda immunità kontrih.
English: On 13 June 2008, Novartis Vaccines and Diagnostics S.r.l.
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra marda.
English: As a result, the size of the clinical database for the assessment of the vaccine's safety was not sufficient to fulfil the requirements of the EMEA's guidelines on prepandemic vaccines.
Maltese: Minħabba f'hekk, id-daqs tad-database klinika għall-valutazzjoni tassigurtà tal-vaċċin ma kienx biżżejjed biex jissodisfa r-rekwiżiti tal-linji gwida ta' l-EMEA fuq ilvaċċini prepandemiċi.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
Maltese: Fit-13 ta' Ġunju 2008, Novartis Vaccines and Diagnostics S.r.l. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Aflunov, għall-prevenzjoni ta' l-influwenza avjarja H5N1 fl-adulti u l-anzjani.
English: Then, the outer membranes that contain the ‘surface antigens' (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Maltese: Imbagħad, il-membrani ta' barra li fihom l‘antiġeni tal-wiċċ' (proteini fuq il-membrana ta' barra tal-varjus li l-ġisem jagħraf bħala barranin) ġew estratti u ppurifikati qabel ma ġew inklużi fil-vaċċin.
English: The full EPAR for Bondronat 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: Bondronat reduced the risk of having a skeletal event by about 40% compared with placebo.
Maltese: Bondronat naqqas ir-riskju ta' avveniment skelettriku b'madwar 40% apparagun mal-plaċebo.
English: Other information about Bondronat
Maltese: Informazzjoni oħra dwar Bondronat
English: This is a summary of the European public assessment report (EPAR) for Bondronat.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bondronat.
English: The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Bondronat, l-aċidu ibandroniku, hija bisfosfonat.
English: Bondronat is a medicine that contains the active substance ibandronic acid.
Maltese: Bondronat huwa mediċina li fiha s-sustanza attiva aċidu ibandroniku.
English: In the prevention of skeletal events, Bondronat is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Maltese: Fil-prevenzjoni ta' avvenimenti skeletriċi, Bondronat jingħata b'infużjoni ta' 6-mg li ddum mill-inqas 15-il minuta kull tlieta sa erba' ġimgħat, jew f'pillola darba kuljum.
English: The most serious side effects with Bondronat are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), and eye inflammation.
Maltese: L-effetti sekondarji l-aktar gravi b'Bondronat huma reazzjoni anafilattika (reazzjoni allerġika gravi), fratturi atipiċi tal-wirk (tip mhux tas-soltu tal-frattura tal-għadma tas-sieq ta' fuq), osteonekrożi tax-xedaq (ħsara lill-għadam tax-xedaq, li tista' twassal għal uġigħ, selħiet fil-ħalq jew laxkament tas-snien) u infjammazzjoni talgħajn.
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat has been compared with placebo (a dummy treatment) in three main studies lasting two years: one with the infusions in 466 patients and two with the tablets in a total of 846 patients.
Maltese: Fil-prevenzjoni ta' avvenimenti skelettriċi f'pazjenti b'kanċer tas-sider u b'metastażi fl-għadam, Bondronat tqabbel ma' plaċebo (kura finta) fi tliet studji ewlenin li saru tul sentejn: wieħed blinfużjonijiet f'466 pazjent u tnejn bil-pilloli f'total ta' 846 pazjent.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and as tablets (50 mg).
Maltese: Jiġi f'konċentrat li jissawwar f'soluzzjoni li tingħata b'infużjoni (dripp) fil-vina, u bħala pilloli (50 mg).
English: It took longer for patients on Bondronat infusions or tablets to develop a new bone complication (50 to 76 weeks) than for patients on placebo (33 to 48 weeks).
Maltese: Il-pazjenti li kienu qed jingħataw Bondronat b'infużjonijiet jew f'pilloli damu aktar sa ma żviluppaw kumplikazzjoni ġdida fl-għadam (50 sa 76 ġimgħa) mill-pazjenti li ngħataw plaċebo (33 sa 48 ġimgħa).
English: Why has Bondronat been approved?
Maltese: Għaliex ġie approvat Bondronat?
English: How has Bondronat been studied?
Maltese: Kif ġie studjat Bondronat?
English: The most common side effects with the tablets are hypocalcaemia and dyspepsia (heartburn).
Maltese: L-effetti sekondarji l-iżjed komuni bil-pilloli huma iperkalċemija u dispepsija (qrusa tal-istonku).
English: About three-quarters responded to a 4-mg dose.
Maltese: Madwar tliet kwarti irreaġġixxew għal doża ta' 4-mg.
English: The most common side effects with Bondronat infusions are a rise in body temperature, hypocalcaemia (low blood calcium levels), asthenia (weakness) and headache.
Maltese: L-effetti sekondarji l-iżjed komuni bl-infużjonijiet b'Bondronat huma tlugħ fit-temperatura tal-ġisem, ipokalċemija (livelli baxxi ta' kalċju fid-demm), astenija (dgħjufija) u wġigħ ta' ras.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bondronat on 25 June 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Bondronat valida fl-Unjoni Ewropea kollha fil-25 ta' Ġunju 1996.
English: Bondronat has also been studied in the treatment of hypercalcaemia caused by tumours in three fourweek studies involving a total of 343 patients.
Maltese: Bondronat ġie studjat ukoll fil-kura tal-iperkalċimja kkaġunata minn tumuri fi tliet studji ta' erba' ġimgħat li saru fuq total ta' 343 pazjent.
English: Bondronat ibandronic acid
Maltese: Sommarju tal-EPAR għall-pubbliku aċidu ibandroniku
English: What is the risk associated with Bondronat?
Maltese: X'inhu r-riskju assoċjat ma' Bondronat?
English: • as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Maltese: • bħala infużjoni jew pillola għall-prevenzjoni ta' ‘avvenimenti skelettriċi' (frattuti [ksur fl-għadam]
English: A risk management plan has been developed to ensure that Bondronat is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Bondronat jintuża bl-aktar mod sigur possibbli.
English: In addition, the company that markets Bondronat will provide a card to inform patients receiving Bondronat infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Bondronat fis-suq ser tipprovdi kard biex tinforma lillpazjenti li jirċievu Bondronat bir-riskju ta' osteonekrożi tax-xedaq u tagħtihom parir jikkuntattjaw littabib tagħhom jekk jesperjenzaw sintomi.
English: For the full list of all side effects and restrictions reported with Bondronat, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u tar-restrizzjonijiet irrappurtati b'Bondronat, ara l-fuljett ta' tagħrif.
English: • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Maltese: • bħala infużjoni fil-kura tal-iperkalċimija (livelli għolja ta' kalċju fid-demm) ikkawżata minn tumuri.
English: What is Bondronat?
Maltese: X'inhu Bondronat?
English: The infusion will normally bring the blood calcium level down to normal levels within a week.
Maltese: L-infużjoni normalment tniżżel illivell tal-kalċju fid-demm għal-livelli normali fi żmien ġimgħa.
English: Bondronat was also effective in treating hypercalcaemia caused by tumours.
Maltese: Bondronat kien aktar effikaċi fil-kura tal-iperkalċemija kkawżata minn tumuri.
English: What is Bondronat used for?
Maltese: Kif jaħdem Bondronat?
English: About a half to two-thirds of the patients responded to a 2-mg dose of Bondronat, with blood calcium levels returning to within the normal range.
Maltese: Madwar nofs sa żewġ terzi tal-pazjenti rreaġġixxew għal doża ta' 2-mg ta' Bondronat, tant li l-livelli ta' kalċju fid-demm tagħhom irritornaw fil-parenteżi normali.
English: How is Bondronat used?
Maltese: Għal xiex jintuża Bondronat?
English: These included spine fractures, fractures outside the spine and any bone complications that needed treatment with radiotherapy or surgery.
Maltese: Dawn inkludew ksur vertebrali, ksur mhux vertebrali u kwalunkwe kumplikazzjoni tal-għadam li ħtieġet kura bir-radjuterapija jew bil-kirurġija.
English: Intravenous use vial (glass) 12 (12x1) vials (multipack)
Maltese: 12 (12x1)-il kunjett (pakkett multiplu)
English: (Invented) name Strength Pharmaceutical form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Pack size
Maltese: Kunjett 1
English: Intravenous use vial (glass) 1 vial
Maltese: Il-pakkett li jmiss mal-prodott
English: Convincing data to identify a patient population in which the benefits of meprobamate clearly outweigh its identified risks.
Maltese: Dejta konvinċenti biex tiġi identifikata popolazzjoni ta' pazjenti li fuqhom il-benefiċċji ta' meprobamat jegħlbu b'mod ċar ir-riskji identifikati tiegħu.
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Maltese: Anness III Kundizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq
English: For the suspension to be lifted, the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Maltese: Biex is-sospensjoni titneħħa, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jeħtieġu jipprovdu lill-Awtoritajiet Kompetenti Nazzjonali b'dan li ġej:
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU)
English: Pack size
Maltese: Mnejn għandu Jingħata
English: 2 sets of constituents
Maltese: Kunjetti tal-ħġieġ 2 settijiet ta' kostitwenti
English: This summary was last updated in 09-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'09-2016.
English: The full EPAR for Elaprase 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: Elaprase is a medicine that contains the active substance idursulfase.
Maltese: Elaprase huwa mediċina li fiha s-sustanza attiva idursulfase.
English: The active substance in Elaprase, idursulfase, is a copy of the human enzyme iduronate-2-sulfatase.
Maltese: Is-sustanza attiva f'Elaprase, l-idursulfase, hija kopja tal-enzima umana iduronate-2-sulfatase.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Elaprase jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Elaprase on 8 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Elaprase valida fl-Unjoni Ewropea kollha fit-8 ta' Jannar 2007.
English: This is a summary of the European public assessment report (EPAR) for Elaprase.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Elaprase.
English: Other information about Elaprase
Maltese: Informazzjoni oħra dwar Elaprase
English: Elaprase is given every week, as an infusion into a vein, at a dose of 0.5 mg per kilogram body weight.
Maltese: Elaprase jingħata kull ġimgħa, bħala infużjoni ġol-vina, f'doża ta' 0.5 mg għal kull kilogramma tal-piż tal-ġisem.
English: Other side effects seen in more than 1 patient in 10 are wheezing, dyspnoea (difficulty breathing), abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), diarrhoea, vomiting, swelling at the site of infusion and chest pain.
Maltese: Effetti sekondarji oħrajn li dehru f'aktar minn pazjent 1 minn 10 huma tħarħir, dispnea (diffikultà biex tieħu n-nifs), uġigħ addominali (uġigħ fl-istonku), nawżja (tħossok ma tiflaħx), dispepsja (ħruq ta' stonku), dijarea, rimettar, nefħa fis-sit tal-infużjoni u wġigħ fis-sider.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku idursulfase
English: At the start of the study, the patients could walk an average of around 395 metres in six minutes.
Maltese: Fil-bidu tal-istudju, il-pazjenti setgħu jimxu medja ta' madwar 395 metru f'sitt minuti.
English: The main study of Elaprase involved 96 male patients aged between 5 and 31 years, and compared it with placebo (a dummy treatment).
Maltese: L-istudju ewlieni ta' Elaprase involva 96 pazjenti rġiel li għandhom bejn il-5 snin u l-31 sena, u qabblu ma' plaċebo (kura finta).
English: Patients with Hunter syndrome do not produce an enzyme called iduronate-2-sulfatase.
Maltese: Pazjenti bis-sindrome ta' Hunter ma jipproduċux enzima msejħa iduronate-2-sulfatase.
English: Why has Elaprase been approved?
Maltese: Għaliex ġie approvat Elaprase?
English: Because the number of patients with Hunter syndrome is low, the disease is considered ‘rare', and Elaprase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Maltese: Minħabba li l-għadd ta' pazjenti li għandhom is-sindrome ta' Hunter huwa baxx, il-marda hija kkunsidrata ‘rari', u għaldaqstant Elaprase ingħata l-klassifikazzjoni ta' ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil-11 ta' Diċembru 2001.
English: How has Elaprase been studied?
Maltese: Kif ġie studjat Elaprase?
English: What information is still awaited for Elaprase?
Maltese: Liema informazzjoni għadha mistennija għal Elaprase?
English: The CHMP concluded that the improvements shown in the study, even if limited, represent a clinical benefit in the treatment of Hunter syndrome.
Maltese: Is-CHMP ikkonkluda li t-titjib muri fl-istudju, anke jekk limitat, jirrappreżenta benefiċċju kliniku fil-kura tas-sindrome ta' Hunter.
English: What is the risk associated with Elaprase?
Maltese: X'inhu r-riskju assoċjat ma' Elaprase?
English: This enzyme is needed to break down substances in the body called glycosaminoglycans (GAGs).
Maltese: Din l-enzima hija meħtieġa biex tkisser sustanzi fil-ġisem imsejħa glikosaminoglikani (GAGs).
English: Elaprase is used to treat patients with Hunter syndrome.
Maltese: Elaprase jintuża biex jikkura l-pazjenti bis-sindrome ta' Hunter.
English: What is Elaprase?
Maltese: X'inhu Elaprase?
English: The most common side effects with Elaprase are related to the infusion, including skin reactions (rash or itching), fever, headache, high blood pressure and flushing.
Maltese: L-effetti sekondarji l-aktar komuni b'Elaprase huma relatati mal-infużjoni, inkluż reazzjonijiet tal-ġilda (raxx jew ħakk), deni, uġigħ ta' ras, pressjoni tad-demm għolja u fwawar.
English: After a year, the patients receiving Elaprase could walk a further 43 metres on average, and the patients receiving placebo could walk a further 8 metres.
Maltese: Wara sena, il-pazjenti li ħadu Elaprase setgħu jimxu 43 metru ieħor bħala medja, u l-pazjenti li ħadu l-plaċebo setgħu jimxu 8 metri oħra.
English: The main measures of effectiveness were lung function (‘forced vital capacity', the maximum amount of air the patient could breathe out), and the distance the patients could walk in six minutes, which measures the combined effects of the illness on the heart, lungs, joints and other organs.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-funzjoni tal-pulmun ('kapaċità vitali sfurzata', l-ammont massimu tal-arja li l-pazjent seta' joħroġ man-nifs 'il barra) u d-distanza li lpazjenti setgħu jimxu f'sitt minuti, li tkejjel l-effetti kkombinati tal-mard fuq il-qalb, il-pulmuni, il-ġogi u organi oħrajn.
English: Severe allergic reactions have occurred in some patients taking Elaprase.
Maltese: Xi wħud mill-pazjenti li ħadu Elaprase kellhom reazzjonijiet allerġiċi gravi.
English: Elaprase idursulfase
Maltese: L-infużjoni jenħtieġ iddum tliet sigħat.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Maltese: Jiġi bħala konċentrat biex jitħallat f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: Patients who tolerate the infusions well for several months in a clinic may be able to start having them at home. Home infusions should be supervised by a doctor or nurse.
Maltese: Il-pazjenti li jittolleraw sew l-infużjonijiet għal diversi xhur fi klinika jistgħu jibdew joħduhom id-dar. Linfużjonijiet fid-dar għandhom ikunu ssorveljati minn tabib jew infermier.
English: Elaprase treatment should be supervised by a doctor or other healthcare professional who has experience in the management of patients with Hunter syndrome or other inherited diseases affecting the metabolism.
Maltese: Il-kura b'Elaprase għandha tkun issorveljata minn tabib jew professjonist ieħor fil-qasam tal-kura tassaħħa b'esperjenza fil-ġestjoni ta' pazjenti bis-sindrome ta' Hunter jew mard ereditarju ieħor li jaffettwa l-metaboliżmu.
English: Elaprase must not be used in people who have had a severe or life-threatening allergic (anaphylactic) reaction to idursulfase or any of the other ingredients if their allergy is not controllable.
Maltese: Elaprase ma għandux jintuża minn persuni li kellhom reazzjoni allerġika (anafilattika) gravi li poġġitilhom ħajjithom f'periklu għal idursulfase jew għal kwalunkwe ingredjent ieħor jekk l-allerġija tagħhom mhijiex kontrollabbli.
English: Hunter syndrome, which is also known as mucopolysaccharidosis II, is a rare, inherited disease that primarily affects male patients.
Maltese: Is-sindrome ta' Hunter, li huwa magħruf ukoll bħala mukopolisakkaridożi II, huwa marda rari li tintiret li taffettwa primarjament lill-pazjenti rġiel.
English: QI09AA03
Maltese: Q109AA03
English: Sodium chloride solution (0.9 %)
Maltese: Soluzzjoni tas-sodium chloride ( 0.9%)
English: Thiomersal
Maltese: Tiomersal