FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose regimen of 100 IU/kg (1 mg/kg) administered twice daily should be used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Maltese: L-iskeda ta' doża ta' 100 UI/kg (1 mg/kg) mogħtija darbtejn kuljum għandha tintuża fil-pazjenti l-oħra kollha bħal dawk b'ħafna piż żejjed, b'PE bis-sintomi, bil-kanċer, b'VTE rikorrenti jew bi trombożi prossimali (vena iliaca).
English: 1.0 mL of solution in a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a black polypropylene plunger rod.
Maltese: 1.0 mL ta' soluzzjoni f'bettija tas-siringa ggradata ta' ħġieġ newtrali ċar, mingħajr kulur tat-tip I b'labra mwaħħla u għatu tal-labra magħluq b'tapp tal-gomma tal-chlorobutyl u virga tal-planġer ta' polypropylene iswed.
English: When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy.
Maltese: Meta jingħata flimkien ma' trombolitiku (speċifiku għall-fibrin jew mhux speċifiku għall-fibrin), enoxaparin sodium għandu jingħata bejn 15-il minuta qabel u 30 minuta wara l-bidu tat-terapija fibrinolitika.
English: This results in differences in pharmacokinetics and associated biological activities (e.g. anti-thrombin activity, and platelet interactions).
Maltese: Dan iwassal għal differenzi fil-farmakokinetika u fl-attivitajiet bijoloġiċi assoċjati magħhom (eż. l-attività kontra t-trombin, u linterazzjonijiet mal-plejtlits).
English: The mean maximum plasma anti-Xa activity level is observed 3 to 5 hours after SC injection and achieves approximately 0.2, 0.4, 1.0 and 1.3 anti-Xa IU/mL following single SC administration of 2,000 IU, 4,000 IU, 100 IU/kg and 150 IU/kg (20 mg, 40 mg, 1 mg/kg and 1.5 mg/kg) doses, respectively.
Maltese: Il-medja tal-livell tal-attività massima anti-Xa fil-plażma jiġi osseervat minn 3 sa 5 sigħat wara injezzjoni SC u jikseb madwar 0.2, 0.4, 1.0 u 1.3 anti-Xa UI/mL wara għoti SC ta' darba ta' dożi ta' 2,000
English: These patients should be observed carefully for signs and symptoms of thromboembolism.
Maltese: Dawn il-pazjenti għandhom jiġu osservati b'attenzjoni għal sinjali u sintomi ta' tromboemboliżmu.
English: 0.2 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod.
Maltese: 0.2 mL ta' soluzzjoni f'bettija tas-siringa ta' ħġieġ newtrali ċar, mingħajr kulur tat-tip I b'labra mwaħħla u għatu tal-labra magħluq b'tapp tal-gomma tal-chlorobutyl u virga tal-planġer ta' polypropylene blu.
English: Medicinal product subject to medical prescription.
Maltese: Armi kwalunkwe mediċina mhux użata.
English: STEMI type of heart attack if you are 75 years old or older:
Maltese: Tip ta' attakk tal-qalb STEMI jekk inti għandek anqas minn 75 sena:
English: In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 710 days whatever the recovery status (e.g. mobility).
Maltese: F'pazjenti b'riskju moderat, it-trattament b'enoxaparin sodium għandu jinżamm għal perjodu minimu ta' 7-10 ijiem irrispettivament mill-istat ta' rkupru (eż. mobilità).
English: When used as curative treatment, aPTT can be prolonged by 1.5-2.2 times the control time at peak activity.
Maltese: Meta jintuża bħala trattament biex jikkura, aPTT jista' jitwal b'1.5-2.2 drabi aktar mill-ħin ta' kontroll meta jkun hemm attività massima.
English: • An initial dose of 3,000 IU (30 mg) of Thorinane will be given as injection into your vein.
Maltese: • Doża tal-bidu ta' 3,000 UI (30 mg) ta' Thorinanese tingħata bħala injezzjoni fil-vina tiegħek.
English: • The usual dose is 150 IU (1.5 mg) for every kilogram of your weight each day or 100 IU (1 mg) for every kilogram of your weight twice a day.
Maltese: • Id-doża s-soltu tkun 150 UI (1.5 mg) għal kull kilogramma tal-piż tiegħek kuljum jew 100 UI (1 mg) għal kull kilogramma tal-piż tiegħek darbtejn kuljum.
English: Thorinane works in two ways.
Maltese: Thorinanejaħdem b'żewġ modi.
English: Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin sodium for thromboprophylaxis.
Maltese: Każijiet iżolati ta' trombożi fil-valv prostetiku tal-qalb kienu rrappurtati f'pazjenti b'valvi mekkaniċi prostetiċi tal-qalb li rċivew enoxaparin sodium għal tromboprofilassi.
English: To reduce the potential risk of bleeding associated with the concurrent use of enoxaparin sodium and epidural or spinal anaesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of enoxaparin sodium (see section 5.2).
Maltese: Biex jitnaqqas ir-riskju possibbli ta' fsada assoċjat mal-użu fl-istess ħin ta' enoxaparin sodium u anestesija/analġesja fis-sinsla jew fl-ispazju madwar id-dura jew titqib tas-sinsla, qis il-profil farmakokinetiku ta' enoxaparin sodium (ara sezzjoni 5.2).
English: These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dosage and clinical efficacy and safety.
Maltese: Dawn il-prodotti mediċinali jvarjaw fil-proċess tal-manifattura tagħhom, fil-piżijiet molekulari, fl-attivitajiet speċifiċi antiXa u anti-IIa tagħhom, fl-unitajiet, fid-doża u fl-effikaċja klinika u s-sigurtà.
English: For continuous techniques, a similar delay of at least 12 hours should be observed before removing the catheter.
Maltese: Għal tekniki kontinwi, dewmien simili ta' mill-anqas 12-il siegħa għandu jiġi osservat qabel ma
English: • Spinal/Epidural anaesthesia or lumbar puncture
Maltese: • Warfarin - jintuża biex iraqqaq id-demm
English: • Rare: Anaphylactic/Anaphylactoid reactions including shock*
Maltese: Reazzjonijiet anafilattiċi/anafilaktojd inkluż xokk*
English: All patients also received warfarin sodium (dose adjusted according to prothrombin time to achieve an INR of 2.0 to 3.0), commencing within 72 hours of initiation of enoxaparin sodium or standard heparin therapy, and continuing for 90 days.
Maltese: Ilpazjenti kollha rċivew ukoll warfarin sodium (doża aġġustata skont il-ħin tal-protrombin biex jinkiseb INR ta' 2.0 sa 3.0), li nbeda fi żmien 72 siegħa minn meta nbdew enoxaparin sodium jew terapija standard bil-heparin, u tkompla għal 90 jum.
English: • Elderly
Maltese: Anzjani
English: Thorinane 6,000 IU (60 mg)/0.6 mL solution for injection
Maltese: Thorinane 6,000 IU (60 mg)/0.6 mL
English: Should the physician decide to administer anticoagulation in the context of epidural or spinal anaesthesia/analgesia or lumbar puncture, frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), bowel and/or bladder dysfunction.
Maltese: Jekk it-tabib jiddeċiedi li jagħti antikoagulazzjoni fil-kuntest ta' anestesija/analġesja fis-sinsla jew flispazju madwar id-dura jew tneħħija ta' fluwidu mis-sit lumbar, għandu jkun hemm monitoraġġ frekwenti biex jiġu nnutati kwalunkwe sinjali u sintomi ta' indeboliment newroloġiku bħal uġigħ f'linja vertikali f'nofs id-dahar, defiċjenzi marbuta mas-sensi jew mal-moviment (titrix jew dgħufija fir-riġlejn), funzjoni ħażina tal-imsaren u jew tal-bużżieqa tal-awrina.
English: In practice, if a confirmed significant decrease of the platelet count is observed (30 to 50 % of the initial value), enoxaparin sodium treatment must be immediately discontinued and the patient switched to another non-heparin anticoagulant alternative treatment.
Maltese: Fil-prattika, jekk jiġi osservat tnaqqis sinifikanti ikkonfermat fl-għadd tal-plejtlits (30 sa 50 % tal-valur inizjali), trattament b'enoxaparin sodium għandu jitwaqqaf immedjatament u l-pazjent għandu jinqaleb fuq trattament antikoagulanti alternattiv li mhuwiex heparin.
English: Plasma potassium should be monitored regularly especially in patients at risk.
Maltese: Il-potassium fil-plażma għandu jiġi mmonitorjat b'mod regolari speċjalment f'pazjenti li qegħdin f'riskju.
English: In a clinical study of pregnant women with mechanical prosthetic heart valves given enoxaparin sodium (100 IU/kg (1 mg/kg ) twice daily) to reduce the risk of thromboembolism, 2 of 8 women developed clots resulting in blockage of the valve and leading to maternal and foetal death.
Maltese: UI/kg bid (1 mg/kg) darbtejn kuljum) biex jitnaqqas ir-riskju ta' tromboemboliżmu, 2 minn 8 nisa żviluppaw tagħqid ta' demm li wassal għal sadda tal-valv u mewt talomm u tal-fetu.
English: Patients receiving the twice daily doses (i.e. 75 IU/kg (0.75 mg/kg) twice daily or 100 IU/kg (1 mg/kg) twice-daily) should omit the second enoxaparin sodium dose to allow a sufficient delay
Maltese: UI/kg (0.75 mg/kg) darbtejn kuljum jew 100 UI/kg (1 mg/kg) darbtejn kuljum) għandhom jaqbżu doża ta' enoxaparin sodium biex jitħalla dewmien biżżejjed għat-tqegħid jew it-tneħħija tal-kateter.
English: Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150-300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75-325 mg/day long-term regardless of treatment strategy.
Maltese: Acetylsalicylic acid huwa rrakkomandat għall-pazjenti kollha mingħajr kontraindikazzjonijiet b'doża għolja fil-bidu ta' 150-300 mg (f'pazjenti li qatt ma jkunu ħadu acetylsalicylic acid) mill-ħalq u doża ta' manteniment ta' 75-325 mg/kuljum mill-ħalq għal tul ta' żmien irrispettivament mill-istrateġija ta'
English: Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4).
Maltese: Globalment, id-dejta tissuġġerixxi li ma hemm l-ebda xhieda ta' żieda fir-riskju ta' emorraġija, tromboċitopenija jew osteoporożi rigward ir-riskju osservat f'nisa mhux tqal, ħlief dak osservat f'nisa tqal b'valvi postetiċi tal-qalb (ara sezzjoni 4.4).
English: Inject the complete contents of the 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe into the 20 mL remaining in the bag.
Maltese: Injetta l-kontenut kollu ta' siringa mimlija għal-lest ta' 6,000 UI (60 mg) enoxaparin sodium fl-20 mL li jkun għad fadal fil-borża.
English: Administration in spinal/epidural anaesthesia or lumbar puncture Should the physician decide to administer anticoagulation in the context of epidural or spinal anaesthesia/analgesia or lumbar puncture, careful neurological monitoring is recommended due to the risk of neuraxial haematomas (see section 4.4).
Maltese: Jekk it-tabib jiddeċiedi li jagħti l-antikoagulazzjoni fil-kuntest ta' anestesija/analġesja fl-ispazju madwar id-dura jew fis-sinsla jew fit-tneħħija ta' fluwidu mis-sit lumbar, huwa rrakkomandat li jsir monitoraġġ newroloġiku minħabba r-riskju ta' ematomi newrassijali (ara sezzjoni 4.4).
English: Intracranial haemorrhage, Retroperitoneal haemorrhage
Maltese: Tromboċitopenija u tromboċitożi
English: Enoxaparin sodium is a low clearance drug with a mean anti-Xa plasma clearance of 0.74 L/h after a 150 IU /kg (1.5 mg/kg) 6-hour IV infusion.
Maltese: L/siegħa wara infużjoni IV ta' 6 sigħat ta' 150 UI /kg (1.5 mg/kg).
English: 111 20 Stockholm Sweden
Maltese: 111 20 Stockholm
English: 205 Alewife Brook Parkway Cambridge, MA 02138 USA
Maltese: 205 Alewife Brook Parkway Cambridge, MA 02138 L-Istati Uniti
English: 300 Shire Way Lexington MA 02421 USA
Maltese: 300 Shire Way Lexington, MA 02421 L-Istati Uniti
English: Age (years)
Maltese: Età (snin)
English: Composite (6MWT and %FVC)
Maltese: Tiżwieqa (6MWT u %FVC)
English: Urine GAG levels (μg GAG/mg creatinine)
Maltese: Livelli ta' GAG flawrina (μg GAG/mg kreatinin)
English: Pack sizes of 1, 4 and 10 vials.
Maltese: Daqsijiet tal-pakkett ta' 1, 4 u10 kunjetti.
English: 1.4 to 7.5 (n=27)
Maltese: 1.4 sa 7.5 (n=27)
English: Mean treatment difference compared with placebo (SE)
Maltese: Differenza medja fit-trattament meta imqabbla ma' plaċebo (SE)
English: 5 to 11 (n=11)
Maltese: 5 sa 11 (n=11)
English: Frequency is given as very common (≥1/10), common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100).
Maltese: Il-frekwenza tingħata bħala komuni ħafna (≥1/10) komuni (≥1/100 sa <1/10) jew mhux komuni (1/1,000 sa <1/100).
English: 12 to 18 (n=8)
Maltese: 12 sa 18 (n=8)
English: The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase.
Maltese: Is-sustanza attiva hi idursulfase, li hi forma ta' l-enzim uman iduronate-2-sulfatase.
English: Urine GAG levels were normalized below the upper limit of normal (defined as 126.6 µg GAG/mg creatinine) in 50% of the patients receiving weekly treatment.
Maltese: Livelli ta' GAG fl-awrina kienu innormalizzati taħt il-limitu ta' fuq tan-normal (iddefiniti bħala 126.6 µg GAG/mg kreatinin) f'50% tal-pazjenti li jirċievu trattament ta' kull ġimgħa.
English: Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) CL (mL/min/kg) Mean ± SD Vss (mL/kg)
Maltese: Cmax (μg/mL) Medja ± SD AUC0-∞ (min*μg/mL) CL (mL/min/kg) Medja ± SD
English: Idursulfase has a molecular weight of approximately 76 kD.
Maltese: Idursulfase għandu piż molekulari ta' madwar 76 kD.
English: Date of first authorisation: 08 January 2007 Date of latest renewal: 09 September 2016
Maltese: Data tal-aħħar tiġdid: 09 ta' Settembru 2016
English: FVC absolute volume (L)
Maltese: Volum assolut FVC (L)
English: This medicinal product contains 0.482 mmol sodium (or 11.1 mg) per vial.
Maltese: 482 mmol ta' sodium (jew 11.1 mg) kull kunjett.
English: Keeping a record
Maltese: Żamma ta' rekord
English: Patients were classified into the following groups: missense (13), complete deletion/large rearrangement (8), and frameshift/ splice site mutations (5).
Maltese: Il-pazjenti ġew ikklassifikati fil-gruppi li ġejjin: sens żbaljat (13), tħassir komplet/riarranġament kbir (8), u mutazzjonijiet frameshift/ splice site (5).
English: Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) Mean ± SD CL (mL/min/kg) Mean ± SD Vss (mL/kg) Mean ± SD
Maltese: Cmax (μg/mL) Medja ± SD AUC0-∞ (min*μg/mL) Medja ± SD CL (mL/min/kg) Medja ± SD Vss (mL/kg) Medja ± SD
English: • Infusion-related reaction (see section entitled “Warnings and precautions”)
Maltese: • Reazzjoni relatata mal-infużjoni (ara s-sezzjoni intitolata “Twissijiet u prekawzjonijiet”)
English: Adverse reaction (preferred term)
Maltese: Reazzjoni avversa (terminu ppreferut)
English: Study HGT-ELA-038
Maltese: Studju HGT-ELA-038
English: The overall neutralizing antibody rate was 26/107 patients (24%).
Maltese: Ir-rata totali ta' antikorpi newtralizzanti kienet 26/107 pazjenti (24%).
English: Clinical study HGT-ELA-038 evaluated immunogenicity in children 16 months to 7.5 years of age.
Maltese: L-istudju kliniku HGT-ELA-038 evalwa l-immunoġeniċità fi tfal ta' bejn 16-il xahar u 7.5 snin.
English: Iduronate-2-sulfatase functions to catabolize the glycosaminoglycans (GAG) dermatan sulfate and heparan sulfate by cleavage of oligosaccharide-linked sulfate moieties.
Maltese: Iduronate-2-sulfatase taħdem biex tikkatabolizza glycosaminoglycans (GAG) dermatan sulfate u heparan sulphate permezz ta' qsim ta' oligosaccharidelinked sulfate moieties.
English: For instructions for use, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar l-użu, ara sezzjoni 6.6.
English: Store in a refrigerator (2C - 8C).
Maltese: Aħżen fi friġġ (2C - 8C).
English: Results from pivotal clinical study at 0.5 mg/kg per week (Study TKT024).
Maltese: Riżultati minn studju kliniku pivotali b'0.5 mg/kg kull ġimgħa (Studju TKT024).
English: Across 4 clinical studies (TKT008, TKT018, TKT024 and TKT024EXT), 53/107 patients (50%) developed anti-idursulfase IgG antibodies at some point.
Maltese: Fil-medda ta' 4 studji kliniċi (TKT008, TKT018, TKT024 u TKT024EXT), 53/107 pazjenti (50%) f'ċertu punt żviluppaw antikorpi
English: Store in a refrigerator (2C - 8C)
Maltese: Aħżen fi friġġ (2C - 8C)
English: Study TKT024
Maltese: Studju TKT024
English: ≥ 40 and < 50 (n=5)
Maltese: ≥ 40 u < 50 (n=5)
English: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Water for injections
Maltese: Dibasic sodium phosphate, heptahydrate Monobasic sodium phosphate, monohydrate Ilma għal injezzjonijiet
English: Idursulfase is secreted as a 525 amino acid glycoprotein and contains 8 N-linked glycosylation sites that are occupied by complex, hybrid, and high-mannose type oligosaccharide chains.
Maltese: Idursulfase tiġi rilaxxata bħala 525 amino acid glycoprotein u fiha 8 siti ta' N-linked glycosylation li huma okkupati minn ktajjen oligosaccharide tat-tip ibridi u b'ħafna mannose kumplessi.
English: Antibodynegative patients were found exclusively in the missense mutation genotype group (see sections 4.4 and 5.1).
Maltese: Pazjenti negattivi għall-anti-korpi instabu esklussivament fil-grupp tal-ġenotipi ta' mutazzjoni ta' sens żbaljat (ara s-sezzjonijiet 4.4 u 5.1).
English: ≥ 30 and < 40 (n=9)
Maltese: ≥ 30 u < 40 (n=9)
English: ≥ 20 and < 30 (n=18)
Maltese: ≥ 20 u < 30 (n=18)
English: Hypoxia, bronchospasm, cough
Maltese: Ipossija, bronkospażmu, sogħla
English: Cyanosis, arrhythmia, tachycardia
Maltese: Ċjanożi, arritmija, takikardija
English: Reductions were evident by week 18 and were maintained to week 53.
Maltese: It-tnaqqis kien evidenti sa ġimgħa 18 u nżamm sa ġimgħa 53.
English: The other ingredients are Polysorbate 20, sodium chloride, dibasic sodium phosphate, heptahydrate, monobasic sodium phosphate, monohydrate and water for injections.
Maltese: Is-sustanzi l-oħra huma Polysorbate 20, sodium chloride, dibasic sodium phosphate, heptahydrate, monobasic sodium phosphate, monohydrate u ilma għall-injezzjonijiet.
English: Hunter syndrome is an X-linked disease caused by insufficient levels of the lysosomal enzyme iduronate-2-sulfatase.
Maltese: Is-sindromu Hunter huwa marda tat-tip X-linked ikkaġunata minn livelli insuffiċjenti ta' l-enzima liżożomali iduronate-2-sulfatase.
English: Elaprase 2 mg/ml sterile concentrate idursulfase
Maltese: Elaprase 2 mg/ml sterili konċentrat idursulfase
English: Spleen volume normalised by Months 12 and 24 for 9.7% of patients in the TKT024 Weekly group with splenomegaly.
Maltese: Il-volum tal-milsa nnormalizza sa Xhur 12 u 24 għal 9.7% tal-pazjenti fil-grupp ta' kull Ġimgħa ta' TKT024 bi splenomegalija.
English: Idursulfase is a purified form of the lysosomal enzyme iduronate-2-sulfatase, produced in a human cell line providing a human glycosylation profile, which is analogous to the naturally occurring enzyme.
Maltese: Idursulfase hija l-forma ippurifikata ta' l-enzima liżożomali iduronate-2-sulfatase, magħmula f'linja ta' ċellula umana li tipprovdi profil ta' glajkosilazzjoni umana, li hija analoga ma' enzima li tinstab naturali.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Maltese: Stabbiltà kimika u fiżika ta' waqt l-użu ġiet murija għal 8 sigħat f'25°C.
English: A total of 108 male Hunter syndrome patients with a broad spectrum of symptoms were enrolled in the two randomized, placebo-controlled clinical studies, 106 continued treatment in two open-label, extension studies.
Maltese: Total ta' 108 pazjenti bis-sindromu Hunter bi spettru wiesa ta' sintomi kienu inklużi fiż-żewġ studji kliniċi fuq bażi każwali, ikkontrollati bi plaċebo, 106 komplew it-trattament f'żewġ studji ta' estensjoni b'tikketta mikxufa.
English: This endpoint differed significantly from placebo for patients treated weekly (p=0.0049).
Maltese: Il-punt ta' tmiem kien ferm differenti mill-plaċebo għal pazjenti ittrattati kull ġimgħa (p=0.0049).
English: Pharmacokinetic parameters at week 1 as a function of age in Studies TKT024 and HGT-ELA-038
Maltese: Tabella 3. Il-parametri farmakokinetiċi f'ġimgħa 1 bħala funzjoni tal-età fi Studji TKT024 u HGT-ELA-038
English: Other medicines and Elaprase
Maltese: Mediċini oħra u Elaprase
English: In a 52-week, randomized, double-blind, placebo-controlled clinical study, 96 patients between the ages of 5 and 31 years received Elaprase 0.5 mg/kg every week (n=32) or 0.5 mg/kg every other week (n=32), or placebo (n=32).
Maltese: Fi studju kliniku ta' 52 ġimgħa, fuq bażi każwali, double-blind, ikkontrollat bi plaċebo, 96 pazjent ta' età bejn 5 u 31 sena rċievew Elaprase 0.5 mg/kg kull ġimgħa (n=32) jew 0.5 mg/kg ġimgħa iva u ġimgħa le (n=32), jew plaċebo (n=32).
English: Among all patients, statistically significant mean increases from treatment baseline (TKT024 baseline for TKT024 idursulfase patients and Week 53 baseline for TKT024 placebo patients) were seen in the distance walked 6MWT at the majority of time points tested, with significant mean and percent increases ranging from 13.7m to 41.5m (maximum at Month 20) and from 6.4% to 13.3% (maximum at Month 24) respectively.
Maltese: Fost il-pazjenti kollha, dehru żidiet medji statistikament sinifikanti mil-linja bażi tal-kura (linja bażi TKT024 għal pazjenti b'idursulfase ta' TKT024 u l-linja bażi ta' Ġimgħa 53 għal pazjenti ta' TKT024 bi plaċebo) fid-distanza li mxew 6MWT fil-maġġoranza tal-punti ta' żmien ittestjati, b'żidiet medji u perċentwali sinifikanti li jvarjaw minn 13.7 m għal 41.5 m (massimu f'Xahar 20) u minn 6.4% għal 13.3% (massimu f'Xahar 24) rispettivament.
English: Heterozygous females were not studied in the clinical trials.
Maltese: Nisa eterożiġotiċi ma ġewx studjati fi provi kliniċi.
English: Typical organs where glycosaminoglycan accumulates are spleen, liver, lungs, heart, and connective tissue.
Maltese: L-organi tipiċi fejn jakkumula glycosaminoglycan huma l-milsa, il-fwied, il-pulmun, il-qalb, u t-tessut konnettiv.
English: Additional clinical benefit analyses were performed on individual components of the primary endpoint composite score, absolute changes in FVC, changes in urine GAG levels, liver and spleen volumes, measurement of forced expiratory volume in 1 second (FEV1), and changes in left ventricular mass (LVM).
Maltese: Saru analiżi ta' benefiċċju kliniku addizzjonali fuq komponenti individwali ta' l-iskor imżewwaq talpunt ta' tmiem primarju, bidliet assoluti fl-FVC, bidliet fil-livelli ta' GAG awrinarji, volumi tal-fwied u l-milsa, miżura tal-volum tan-nifs sfurzat 'il barra (FEV1), u bidliet fil-massa ventrikulari tax-xellug (LVM).
English: Of these 6 (40%) had normalised LVM by the end of the study.
Maltese: Minn dawn 6 (40%) kellhom LVM innormalizzat sa tmiem l-istudju.
English: Posology
Maltese: Takipneja
English: Swollen tongue, dyspepsia
Maltese: Nefħa fl-ilsien, dispepsija
English: Liver volume normalised by Month 24 for 73% (52 out of 71) of patients with hepatomegaly at baseline.
Maltese: Il-volum tal-fwied innormalizza sa Xahar 24 għal 73% (52 minn 71) tal-pazjenti b'epatomegalija fil-linja bażi.
English: How to store Elaprase
Maltese: Tużax Elaprase
English: Degradation of idursulfase is achieved by generally well understood protein hydrolysis mechanisms to produce small peptides and amino acids, consequently renal and liver function impairment is not expected to affect the pharmacokinetics of idursulfase.
Maltese: Degradazzjoni ta' idursulfase tinkiseb permezz ta' mekkaniżmi mifhuma sewwa ta' idroliżi tal-proteina biex jipproduċu peptidi u aċidi amino, konsegwentemant funzjoni indebolita renali u tal-fwied mhix mistennija li taffettwa il-farmakokinetiċi ta' idursulfase.
English: • Abdominal pain, nausea, vomiting, frequent and/or loose stools
Maltese: • Uġigħ addominali, nawseja, rimettar, ippurgar frekwenti u/jew maħlul
English: The safety and efficacy of Elaprase has been shown in three clinical studies: two randomised, placebo-controlled clinical studies (TKT008 and TKT024) in adults and children above the age of 5 years and one open-label, safety study (HGT-ELA-038) in children between the age of 16 months and 7.5 years.
Maltese: Is-sigurtà u l-effikaċja ta' Elaprase intwerew fi tliet studji kliniċi: żewġ studji kliniċi kkontrollati bi plaċebo randomizzati (TKT008 u TKT024) fl-adulti u fi tfal ta' aktar minn 5 snin u studju tas-sigurtà bit-tikketta mikxufa (HGT-ELA-038) fi tfal bejn l-etajiet ta' 16-il xahar u 7.5 snin.