FrancophonIA/ELRC3.0 huggingface dataset:
English: In the post-hoc immunogenicity analysis of data from TKT024/024EXT studies, 51% (32/63) patients treated with 0.5mg/kg weekly idursulfase had at least 1 blood sample that tested positive for antiidursulfase antibodies, and 37 % (23/63) tested positive for antibodies on at least 3 consecutive study visits.
Maltese: Fl-analiżi tal-immunoġeniċità post-hoc ta' dejta mill-istudji TKT024/024EXT, 51% (32/63) pazjenti kkurati b'0.5 mg/kg kull ġimgħa, idursulfase kellu għallinqas kampjun 1 tad-demm li ġie ttestjat pożittiv għal anti-korpi kontra idursulfase, u 37% (23/63) ittestjaw pożittivi għal antikorpi fuq għallinqas 3 żjarat ta' studju konsekuttivi.
English: This medicine has been authorised under “exceptional circumstances”.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: The study included patients with a documented deficiency in iduronate-2sulfatase enzyme activity, a percent predicted FVC <80%, and a broad spectrum of disease severity.
Maltese: L-istudju nkluda pazjenti b'defiċjenza dokumentata fl-attività ta' l-enzima iduronate-2-sulfatase, FVC perċentwali mbassar <80%, u spettru wiesa' ta' serjetà talmarda.
English: Concentrate for solution for infusion 3 ml
Maltese: Konċentrat għal soluzzjoni għal-infużjoni 3 ml
English: Nervous system disorders Headache
Maltese: Disturbi gastro-intestinali
English: Idursulfase is produced in a human cell line by genetic engineering technology (it involves the introduction of genetic information into human cells in the lab, which will then produce the desired product).
Maltese: Idursulfase jiġi prodott f'linja ta' ċelloli umani permezz tat-teknoloġija ta' l-inġinerija ġenetika (tinvolvi lintroduzzjoni ta' informazzjoni ġenetika fiċ-ċelloli umani fil-laboratorju, li mbagħad jipproduċu lprodott mixtieq).
English: P-value (compared with placebo)
Maltese: Valur-P (imqabbel ma' plaċebo)
English: - The total volume required of Elaprase should be diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
Maltese: - Il-volum totali meħtieġ ta' Elaprase għandu jiġi dilwit f'100 ml ta' 9 mg/ml (0.9%) soluzzjoni ta' sodium chloride għal infużjoni.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB09.
Maltese: Prodotti oħra tal-passaġġ ta' l-ikel u metaboliżmu - enżimi, Kodiċi ATC:
English: ▼This medicine is subject to additional monitoring.
Maltese: ▼Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Table 1: Adverse reactions from clinical trials and post-marketing experience in patients treated with Elaprase.
Maltese: Tabella 1: Reazzjonijiet avversi minn provi kliniċi u esperjenza wara t-tqegħid fis-suq f'pazjenti ttrattati b'Elaprase.
English: This is equivalent to 0.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.6% tal-konsum massimu ta' kuljum rakkomandat mid-WHO ta' 2 g sodium għal adult.
English: Elaprase contains sodium
Maltese: Elaprase fih is-sodium
English: Infusion-related reactions were treated or ameliorated by slowing the infusion rate, interrupting the infusion, or by administration of medicinal products, such as antihistamines, antipyretics, low-dose corticosteroids (prednisone and methylprednisolone), or beta-agonist nebulisation.
Maltese: Reazzjonijiet relatati ma' l-infużjoni kienu ittrattati jew imtejjba billi tnaqqset ir-rata ta' l-infużjoni, twaqqif ta' l-infużjoni, jew permezz ta' amministrazzjoni ta' prodotti mediċinali, bħalma huma mediċini kontra l-ħistamina, kontra d-deni, kortikosterojdi f'doża baxxa (prednisone u methylprednisolone), jew nebulizzazzjoni b'agonist-beta.
English: • Swollen tongue, indigestion
Maltese: • Ħmura tal-ġilda, indiġestjoni
English: Pharmacokinetic parameters at week 1 as a function of body weight in studies TKT024 and HGT-ELA-038
Maltese: Il-parametri farmakokinetiċi f'ġimgħa 1 bħala funzjoni tal-piż tal-ġisem fi studji TKT024 u HGT-ELA-038
English: Assessment of long term pulmonary morbidity (e.g., incidence of infections, pulmonary function status) and mortality Assessment of long term cardiovascular morbidity (e.g., incidence of events, and echocardiography data, where available) and mortality Assessment of long term urinary GAG excretion patterns Assessment of long term antibody levels, isotype and correlation to other therapeutic parameters
Maltese: - Stima tal-morbożità (eż., l-inċidenza ta' infezzjonijiet, l-istejtus talfunzjoni pulmonari) u l-mortalità pulmonari fuq żmien twil - Stima tal-morbożità (eż., l-inċidenza tal-avvenimenti, u dejta ekokardjografika, fejn din tkun disponibbli) u l-mortalità kardjovaskulari fuq żmien twil - Stima tal-modi ta' tneħħija tal-GAG fl-awrina fuq żmien twil - Stima tal-livelli tal-antikorpi, l-isotip u l-korrelazzjoni ma' parametri terapewtiċi oħrajn fuq żmien twil
English: The complete deletion/ large rearrangement genotype was most commonly associated with development of high titre of antibodies and neutralising antibodies to idursulfase and was most likely to display a muted response to the medicinal product.
Maltese: Il-ġenotip ta' tħassir komplet / riarranġament kbir kien spiss assoċjat mal-iżvilupp ta' titre għoli ta' antikorpi u ta' antikorpi newtralizzanti għal idursulfase u kien probabbli li juri rispons imtaffi għallprodott mediċinali.
English: In the placebo treatment group 128 infusion-related reactions were reported in 21 out of 32 patients following administration of a total of 1612 infusions.
Maltese: Fil-grupp ta' trattament bil-plaċebo, ġew irrapportati 128 reazzjoni relatata ma' l-infużjoni f'21 minn 32 pazjent wara l-amministrazzjoni ta' total ta' 1612-il infużjoni.
English: Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Wheezing, dyspnoea
Maltese: Pressjoni għolja, Pressjoni baxxa Disturbi respiratorji, toraċiċi u medjastinali Tħarħir, dispneja
English: The most common were infusion-related reactions, 202 of which were reported in 22 out of 32 patients following administration of a total of 1580 infusions.
Maltese: L-aktar komuni kienu reazzjonijiet relatati ma' l-infużjoni, li 202 minnhom ġew rapportati fi 22 minn 32 pazjent wara l-amministrazzjoni ta' total ta' 1580 infużjoni.
English: Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion .
Maltese: Iddilwa l-volum totali meħtieġ ta' Elaprase f'100 ml ta' soluzzjoni ta' sodium chloride ta' 9 mg/ml (0.9%) għal infużjoni.
English: Approximately half of the patients in the weekly treatment group (15 of 32; 47%) had left ventricular hypertrophy at baseline, defined as LVM index 103 g/m2.
Maltese: Bejn wieħed u ieħor nofs il-pazjenti fil-grupp ta' trattament ta' kull ġimgħa (15 minn 32; 47%) kellhom ipertrofija ventrikulari xellugija fil-linja bażi, iddefinita bħal indiċi LVM 103 g/m2.
English: Patients with complete deletion/large rearrangement genotype have a higher probability of developing infusion related adverse events (see section 4.4).
Maltese: Pazjenti b'ġenotip ta' tħassir komplet/riarranġament kbir għandhom probabilità akbar li jiżviluppaw episodji avversi relatati mal-infużjoni (ara sezzjoni 4.4).
English: Mannose-6-phosphate (M6P) residues on the oligosaccharide chains allow specific binding of the enzyme to the M6P receptors on the cell surface, leading to cellular internalization of the enzyme, targeting to intracellular lysosomes and subsequent catabolism of accumulated GAG.
Maltese: Residwi ta' mannose-6-phosphate (M6P) fuq il-ktajjen ta' oligosaccharide iħallu rbit speċifiku ta' l-enzima ma' riċetturi M6P fuq il-wiċċ taċ-ċellola, li jwassal għal internalizzazzjoni ċellolari ta' l-enzima, immirata għal liżożomi ċellolari u kataboliżmu sussegwenti ta' GAG akkumulati.
English: At their final visit 21/31 patients in the TKT024 Weekly group, 24/32 in the TKT024 EOW group and 18/31 patients in the TKT024 placebo group had final normalised urine GAG levels that were below the upper limit of normal.
Maltese: Fil-viżta finali tagħhom, 21/31 pazjent fil-grupp ta' Kull Ġimgħa ta' TKT024, 24/32 fil-grupp ta' TKT024 ġimgħa iva u ġimgħa le u 18/31 pazjent fil-grupp tal-plaċebo ta' TKT024 kellhom livelli ta' GAG tal-awrina normalizzati finali li kienu taħt il-limitu ta' fuq tan-normal.
English: There is no clinical experience in patients over 65 years of age.
Maltese: Ma hemm l-ebda esperjenza klinika f'pazjenti li għandhom aktar minn 65 sena.
English: Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Maltese: Idursulfase m'huwiex kandidat għal interazzjonijiet medjati minn ċitokroma P450, fuq il-bażi talmetaboliżmu tagħha f'liżożomi ċellulari.
English: Tachypnoea
Maltese: FARMAĊEWTIKU
English: In a post-hoc analysis of immunogenicity in studies TKT024 and TKT024EXT (see section 4.8), patients were shown to have either the mis-sense mutation or the frameshift / nonsense mutation.
Maltese: F'analiżi post-hoc tal-immunoġeniċità fl-istudji TKT024 u TKT024EXT (ara sezzjoni 4.8), il-pazjenti ntwerew li għandhom jew il-mutazzjoni ta' sens żbaljat jew il-mutazzjoni frameshift / ma tagħmilx sens.
English: A higher volume of distribution at steady state (Vss) was observed in the lowest weight groups.
Maltese: Volum akbar ta' distribuzzjoni fi stat fiss (Vss) ġie osservat fl-inqas gruppi ta' piż.
English: A total of 11 of 31 (36%) patients in the weekly treatment group versus 5 of 31 (16%) patients in the placebo group had an increase in FEV1 of at least 0.2 l at or before the end of the study, indicating a dose-related improvement in airway obstruction.
Maltese: Total ta' 11-il pazjent minn 31 (36%) fil-grupp ta' trattament ta' kull ġimgħa kontra 5 pazjenti minn 31 (16%) fil-grupp tal-plaċebo kellhom żieda fl-FEV1 ta' mill-inqas 0.2 l fi jew qabel tmiem l-istudju, u dan jindika titjib kontra l-imblokkar tal-passaġġ ta' l-arja relatat mad-doża.
English: Idursulfase
Maltese: TIKKETTAR
English: Placebo
Maltese: Idursulfase Plaċebo
English: Late emergent symptoms and signs of anaphylactoid/anaphylactic reactions have been observed as long as 24 hours after an initial reaction.
Maltese: Sintomi li joħorġu tard u sinjali ta' reazzjonijiet anafilaktojdi/anafilattiċi ġew osservati għal 24 siegħa wara r-reazzjoni inizjali.
English: Method of administration For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Metodu ta' kif għandu jingħata Għal struzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Mean changes from 0.07 l to 0.31 l and percent ranged from 6.3% to 25.5% (maximum at Month 30).
Maltese: It-tibdiliet medji kienu minn 0.07 l għal 0.31 l u l-perċentwal varja minn 6.3% għal 25.
English: Due to the missing or defective iduronate-2-sulfatase enzyme in patients with Hunter syndrome, glycosaminoglycans progressively accumulate in the cells, leading to cellular engorgement, organomegaly, tissue destruction, and organ system dysfunction.
Maltese: Minħabba l-enzima iduronate-2-sulfatase nieqsa jew difettuża f'pazjenti bissindromu Hunter, il-glycoaminoglycans jakkumulaw progressivament fiċ-ċelloli, u jwasslu għal nefħa ċellolari, organomegalija, qerda tat-tessuti, u funzjoni ħażina tas-sistema ta' l-organi.
English: Each vial contains 6 mg of idursulfase.
Maltese: Kull kunjett fih 6 mg ta' idursulfase.
English: The current medical standards for emergency treatment are to be observed.
Maltese: Għandhom jiġu segwiti listandardis mediċi attwali għal trattament ta' emerġenza.
English: Dizziness, tremor
Maltese: Tqala u treddigħ
English: Idursulfase is taken up by selective receptor-mediated mechanisms involving binding to mannose 6phosphate receptors.
Maltese: Idursulfase jittieħed permezz ta' mekkaniżmi selettivi medjati mir-riċetturi li jinvolvu rbit ma' riċetturi ta' mannose 6-phosphate.
English: Patients with the most severe pulmonary impairment at baseline (as measured by % predicted FVC) tended to show the least improvement.
Maltese: Pazjenti bl-aktar indeboliment pulmonari serju fil-linja bażi (kif imkejjel b'FVC % mbassar) kellhom it-tendenza li juru l-inqas titjib.
English: The most common of these infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria, and erythema), pyrexia, flushing, wheezing, dyspnoea, headache, vomiting,
Maltese: L-aktar komuni fost dawn ir-reazzjonijiet relatati ma' l-infużjoni kien hemm reazzjonijiet tal-ġilda (raxx, prurite, urtikarja u eritema), deni, fwawar, tħarħir, dispneja, uġigħ ta' ras, rimettar, uġigħ addominali, nawseja u uġigħ fis-sider.
English: During clinical trials, the most common infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, hypertension, and flushing.
Maltese: Waqt provi kliniċi, l-aktar reazzjonijiet komuni relatati ma' l-infużjoni inkludew reazzjonijiet fil-ġilda (raxx, prurite, urtikarja), deni, uġigħ ta' ras, pressjoni għolja, u fwawar.
English: Adverse reactions reported in the paediatric population were, in general, similar to those reported in adults.
Maltese: Reazzjonijiet avversi rrapportati fil-popolazzjoni pedjatrika kienu, b'mod ġenerali, simili għal dawk irrapportati fl-adulti.
English: Patients with the complete deletion/large rearrangement genotype Paediatric patients with the complete deletion/large rearrangement genotype have a high probability of developing antibodies, including neutralizing antibodies, in response to exposure to idursulfase.
Maltese: Pazjenti bil-ġenotip ta' tħassir komplet/riarranġament kbir Pazjenti pedjatriċi bil-ġenotip ta' tħassir komplet/riarranġament kbir għandhom probabilità għolja li jiżviluppaw antikorpi, inkluż antikorpi newtralizzanti, b'rispons għal espożizzjoni għal idursulfase.
English: Elaprase is used as enzyme replacement therapy to treat children and adults with Hunter syndrome (Mucopolysaccharidosis II) when the level of the enzyme iduronate-2-sulfatase in the body is lower than normal, helping improve the symptoms of the disease.
Maltese: Elaprase jintuża bħala terapija ta' sostituzzjoni ta' l-enzimi biex jikkura tfal u adulti bis-sindromu ta' Hunter (Mucopolysaccharidosis II) meta l-livell tal-enzim iduronate-2-sulfatase fil-ġisem ikun iktar baxx mis-soltu, fejn jgħin fit-titjib tas-sintomi tal-marda.
English: This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.6% tal-konsum massimu rakkomandat ta' sodium meħud fid-dieta kuljum għal adult.
English: Fertility No effects on male fertility were seen in reproductive studies in male rats.
Maltese: Fertilità L-ebda effett fuq il-fertilità tal-irġiel ma deher fi studji riproduttivi f'firien irġiel.
English: Pharmacokinetic parameters measured during the first infusion at week 1 of studies TKT024 (0.5 mg/kg weekly arm) and HGT-ELA-038 are displayed in table 3 and table 4 below as a function of age and body weight, respectively.
Maltese: Il-parametri farmakokinetiċi mkejla matul l-ewwel infużjoni f'ġimgħa 1 tal-istudji TKT024 (fergħa ta' 0.5 mg/kg fil-ġimgħa) u HGT-ELA-038 huma murija f'tabella 3 u f'tabella 4 ta' hawn taħt bħala funzjoni tal-età u piż tal-ġisem, rispettivament.
English: The patients in the weekly treatment group experienced a clinically significant 15% mean improvement in FEV1 at the end of the study.
Maltese: Il-pazjenti fil-grupp ta' trattament ta' kull ġimgħa esperjenzaw titjib medju ta' 15% klinikament sinifikattiv f'FEV1 fit-tmiem ta' l-istudju.
English: 52 weeks of treatment 0.5 mg/kg weekly Marginally weighted (OM) mean (SE)
Maltese: Punt ta' tmiem 52 ġimgħa ta' trattament 0.5 mg/kg kull ġimgħa
English: • Infusion-site swelling, swelling of the extremities, facial swelling
Maltese: • Nefħa fis-sit ta' l-infużjoni, nefħa fl-estremitajiet, nefħa fil-wiċċ
English: Analyses of genotypes of patients in study HGT-ELA-038
Maltese: Analiżi ta' ġenotipi ta' pazjenti fi studju HGT-ELA-038
English: Each vial of Elaprase contains 6 mg of idursulfase.
Maltese: Kull kunjett ta' Elaprase jkun fiha 6 mg idursulfase.
English: Adverse reactions are listed in table 1 with information presented by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati f'tabella 1 b'tagħrif ippreżentat permezz ta' sistema talklassifika tal-organi u frekwenza.
English: Elaprase 2 mg/ml concentrate for solution for infusion idursulfase
Maltese: Elaprase 2 mg/ml konċentrat għal soluzzjoni għal-infużjoni idursulfase
English: 5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion.
Maltese: Kunjett ta' 5 ml (ħġieġ tip I) b'tapp (lastiku butyl -miksi bi fluoro-resin), siġill f'biċċa waħda u kappa blu li titneħħa b'saba' wieħed.
English: Patients in the TKT024 and HGT-ELA-038 studies were also stratified across five weight categories; as shown in the following table:
Maltese: Il-pazjenti fl-istudji TKT024 u HGT-ELA-038 ġew stratifikati wkoll tul ħames kategoriji ta' piż, kif muri fit-tabella li ġejja:
English: The fifth patient, who had preexisting cardiopathy, was diagnosed with ventricular premature complexes and pulmonary embolism during the study.
Maltese: Il-ħames pazjent, li kellu kardjomajopatija diġà eżistenti, ġie dijanjożizzat li kellu kumplessi ventrikulari prematuri u emboliżmu pulmonari waqt l-istudju.
English: Idursulfase treatment resulted in up to 60% reduction in urine output of glycosaminoglycans and in reductions of liver and spleen size: results were comparable to those found in study TKT024.
Maltese: Il-kura b'idursulfase irriżultat fi tnaqqis ta' mhux aktar minn 60% fl-eliminazzjoni ta' glycosaminoglycans fl-awrina u fi tnaqqis tad-daqs tal-fwied u tal-milsa: ir-riżultati kienu komparabbli ma' dawk li nstabu fl-istudju TKT024.
English: Flushing
Maltese: Treddigħ
English: Each ml contains 2 mg of idursulfase*.
Maltese: Kull ml fih 2 mg ta' idursulfase*.
English: After 105 weeks of exposure to idursulfase, neither antibody status nor genotype affected reductions in liver and spleen size or distance walked in the 6-minute walk test or forced vital capacity measurements.
Maltese: Wara 105 ġimgħat ta' espożizzjoni għal idursulfase, la l-istatus u lanqas il-ġenotip tal-antikorpi ma affettwaw it-tnaqqis fid-daqs tal-fwied u tal-milsa jew id-distanza li mxew fit-test tal-mixi ta' 6 minuti jew il-kejl tal-kapaċità vitali furzata.
English: Anaphylactoid/ anaphylactic reaction
Maltese: Reazzjonijiet anafilaktojdi/anafilattiċi
English: All patients with the frameshift/splice site mutation genotype developed antibodies and 4/6 also tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Maltese: Il-pazjenti kollha bil-ġenotip ta' mutazzjoni frameshift/splice site żviluppaw antikorpi u 4/6 ittestjaw ukoll pożittivi għall-antikorpi newtralizzanti f'mill-inqas 3 żjarat konsekuttivi tal-istudju.
English: During the 53-week study, 67.9% (19 of 28) of patients had at least one blood sample that tested positive for anti-idursulfase antibodies, and 57.1% (16 of 28) tested positive for antibodies on at least three consecutive study visits.
Maltese: Matul l-istudju ta' 53 ġimgħa, 67.9% (19 minn 28) tal-pazjenti kellhom għallinqas kampjun tad-demm wieħed li ttestja pożittiv għal antikorpi kontra idursulfase, u 57.1% (16 minn 28) ittestjaw pożittivi għal antikorpi f'għallinqas tliet żjarat konsekuttivi tal-istudju.
English: 6MWT (m)
Maltese: 6MWT (m) % FVC Previst
English: Twenty-one percent (13/63) tested positive for neutralizing antibodies at least once and 13 % (8/63) tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Maltese: Wieħed u għoxrin fil-mija (13/63) ittestjaw pożittivi għal antikorpi newtralizzanti għallinqas darba u 13% (8/63) ittestjaw pożittivi għal antikorpi newtralizzanti f'mill-inqas 3 żjarat ta' studju konsekuttivi.
English: The primary efficacy endpoint was a two-component composite score based on the sum of the ranks of the change from baseline to the end of the study in the distance walked during six minutes (6minute walk test or 6MWT) as a measure of endurance, and % predicted forced vital capacity (FVC) as a measure of pulmonary function.
Maltese: Il-punt tat-tmiem primarju ta' l-effikaċja kien skor imżewwaq b'żewġ komponenti ibbażat fuq issomma tar-ranki tal-bidla mil-linja bażi sat-tmiem ta' l-istudju fid-distanza koperta matul sitt minuti (test ta' mixja ta' 6-minuti jew 6MWT) bħala miżura tal-kapaċità li wieħed jissaporti t-tbatija, u lkapaċità % vitali sfurzata prevista (FVC) bħala miżura tal-funzjoni pulmonari.
English: These events did not recur with subsequent infusions using a slower infusion rate and administration of pre-infusion medicinal products, usually low-dose steroids, antihistamine, and beta-agonist nebulisation.
Maltese: Dawn l-episodji ma reġgħux seħħew b'infużjonijiet sussegwenti bl-użu ta' rata ta' infużjoni aktar bil-mod u amministrazzjoni ta' prodotti mediċinali qabel l-infużjoni, ġeneralment sterojdi f'dożi baxxi, mediċini kontra l-ħistamina u nebulizzazzjoni b'agonist-beta.
English: Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use.
Maltese: Elaprase huwa għal-infużjoni intravenuża u għandu jiġi dilwit f'soluzzjoni għalinfużjoni ta' sodium chloride 9 mg/ml (0.9%) qabel l-użu.
English: Each ml contains 2 mg of idursulfase.
Maltese: Kull millilitru jkun fih 2 mg idursulfase.
English: Treatment of Hunter syndrome patients with intravenous idursulfase provides exogenous enzyme for uptake into cellular lysosomes.
Maltese: Trattament intravenuż b'idursulfase fuq pazjenti bis-sindromu Hunter jipprovdi enzima eżoġena biex tittieħed fil-liżożomi ċellolari.
English: • Rapid heartbeat, irregular heartbeat, bluish skin
Maltese: • Taħbit mgħaġġel tal-qalb, taħbit irregolari tal-qalb, ġilda kaħlanija
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul talRMP.
English: • Hives, rash, itching, redness of the skin
Maltese: IL-KONTENUT SKONT IL-PIŻ, VOLUM, JEW PARTI
English: Specific Obligation 1 - Hunter Outcome Survey (HOS): available data and updates will be provided within Annual Reassessments.
Maltese: Obbligu Speċifiku 1 - Stħarriġ dwar ir-Riżultati tal-Marda ta' Hunter (HOS): id-dejta disponibbli u l-aġġornamenti sejrin jiġu pprovduti fl-Istimi mill-ġdid li jsiru kull sena.
English: Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 if hypersensitivity is not controllable.
Maltese: Sensittività eċċessiva severa jew ta' theddida għas-saħħa għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1, jekk is-sensittività eċċessiva ma tkunx kontrollabbli.
English: Please consult your doctor for additional information.
Maltese: Jekk jogħġbok ikkonsulta lit-tabib tiegħek għal informazzjoni addizzjonali.
English: Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Maltese: Elaprase huwa indikat għat-trattament fuq tul ta' żmien ta' pazjenti bis-sindromu ta' Hunter (Mucopolysaccharidosis
English: Elaprase 2 mg/ml concentrate for solution for infusion
Maltese: Elaprase 2 mg/ml konċentrat għal soluzzjoni għal-infużjoni
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3). Bħala prekawzjoni hu preferibbli li ma j/tintuzax idursulfasewaqt it-tqala.