FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G6PD deficiency before starting KRYSTEXXA.
Maltese: Il-pazjenti kollha li qegħdin f'riskju ogħla għal defiċjenza ta' G6PD (eż. pazjenti ta' dixxendenza Afrikana jew Mediterranja) għandhom jiġu skrinjati għal defiċjenza ta' G6PD qabel ma jibdew jieħdu KRYSTEXXA.
English: A total of 32% (27 of 85) of patients treated with KRYSTEXXA 8 mg every 2 weeks had a creatinine clearance of ≤62.5 ml/min.
Maltese: Total ta' 32% (27 minn 85) tal-pazjenti li rċevew kura bi KRYSTEXXA 8 mg kull ġimgħatejn kellhom tneħħija ta' krejatinina ta' ≤62.5 ml/min.
English: As shown in Table 3 at Month 6, the percentage of patients who achieved complete tophus response (defined as 100% resolution of at least one target tophus, without the appearance of any new tophi or any progression of existing tophi) was 29.0% in patients treated with 8 mg pegloticase every 2 weeks compared to 6.9% in placebo patients excluding patients with missing data, who were considered as a failure.
Maltese: Kif jidher fit-Tabella 3 fix-Xahar 6, il-persentaġġ ta' pazjenti li kisbu rispons sħiħ tat-tofus (definit bħala riżoluzzjoni ta' 100% ta' millinqas tofus wieħed fil-mira, mingħajr il-dehra ta' xi tofi ġodda jew xi progressjoni tat-tofi eżistenti) kien ta' 29.0% f'pazjenti li rċevew kura bi 8 mg pegloticase kull ġimgħatejn meta mqabbla ma' 6.9% f'pazjenti li rċevew plaċebo imma bl-esklużjoni ta' pazjenti b'dejta nieqsa, li kienu kkunsidrati bħala li fallew.
English: Physical and chemical stability of KRYSTEXXA diluted in 250 ml sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) has been demonstrated for 4 hours at 2°C to 8°C and at room temperature (20°C to 25°C), if the solution is prepared as described in section 6.6.
Maltese: L-istabbiltà fiżika u kimika ta' KRYSTEXXA dilwit f'250 ml ta' klorur tas-sodju 4.5 mg/ml (0.45%) jew 9 mg/ml (0.9%) intweriet għal 4 sigħat f'temperatura ta' 2°C sa 8°C u f'temperatura talkamra (20°C sa 25°C), jekk is-soluzzjoni tiġi ppreparata kif deskritt fis-sezzjoni 6.6.
English: Instructions for preparation of the solution for infusion:
Maltese: Istruzzjonijiet għall-preparazzjoni tas-soluzzjoni għal infużjoni:
English: Disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections
Maltese: Disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, klorur tas-sodju, ilma għall-injezzjonijiet
English: 1 95% confidence interval for differences in responder rate between pegloticase group vs. placebo 2 P-value using Fisher's exact test to compare pegloticase group vs. placebo 3GOUT = Gout Outcomes and Urate-lowering Therapy
Maltese: Intervall ta' fiduċja ta' 95% fir-rata ta' rispons bejn il-grupp ta' pegloticase kontra l-plaċebo Valur-P bl-użu tat-test eżatt ta' Fisher biex iqabbel il-grupp ta' pegloticase kontra l-plaċebo GOTTA = Riżultati tal-Gotta u Terapija li Tnaqqas l-Urate
English: KRYSTEXXA is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated (see section 4.4).
Maltese: KRYSTEXXA huwa indikat għall-kura tal-gotta tophaceous kronika severa u debilitanti fuq pazjenti adulti li jista' jkollhom ukoll l-involviment ta' erosive joint u li jkunu naqsu milli jinnormalizzaw laċidu uriku fis-serum permezz ta' inibituri ta' xanthine oxidase fid-doża massima medikament adegwata jew li għalihom dawn il-mediċini ikunu kontraindikati (ara sezzjoni 4.4).
English: Plasma Uric Acid < 6 mg/dl for at Least 80% of the Time During Months 3 and 6 Treatment Group
Maltese: Aċidu uriku fil-plasma < 6 mg/dl għal mill-Inqas 80% tal-Ħin Matul ix-Xhur 3 u 6 Għadd (%) ta' Suġġetti li Laħqu lKriterji ta' Rispons
English: Clearance was 0.0145 L/h with a range of 0.00904 - 0.0229 for no increase in anti-pegloticase antibodies and 0.0193 L/h with a range of 0.00675 - 0.0340 for an increase in anti-pegloticase antibodies.
Maltese: It-tneħħija kienet ta' 0.0145 L/h b'firxa ta' 0.009040.0229 għall-ebda żieda fl-antikorpi kontra pegloticase u ta' 0.0193 L/h b'firxa ta' 0.00675 - 0.
English: p-Value2
Maltese: Valur-p
English: Infusion-related reactions / Anaphylaxis
Maltese: Reazzjonijiet relatati mal-infużjoni /Anafilassi
English: 2 ml vial (Type I glass) with a Teflon coated bromobutyl rubber stopper and aluminium seal with polypropylene flip-off cap, containing 1 ml concentrate for solution for infusion.
Maltese: Kunjett ta' 2 ml (ħġieġ tat-Tip I) b'tapp tal-gomma tal-bromobutyl miksi bit-Teflon u siġill tal-aluminju b'għatu tal-polypropylene tat-tip flip-off, li fih 1 ml ta' konċentrat għal soluzzjoni għal infużjoni.
English: From the nonclinical studies, the elimination of pegloticase is via renal/urinary excretion.
Maltese: Mill-istudji mhux kliniċi, l-eliminazzjoni ta' pegloticase hija permezz tat-tneħħija renali/urinarja.
English: Bio-Technology General (Israel) Ltd. Be'er Tuvia Industrial Park Kiryat Malachi 83104
Maltese: Bio-Technology General (Israel) Ltd.
English: KRYSTEXXA 8 mg concentrate for solution for infusion pegloticase
Maltese: KRYSTEXXA 8 mg konċentrat għal soluzzjoni għal infużjoni pegloticase
English: The volume of distribution was 4.45 L with a range of 2.625.89 for no increase in anti-pegloticase antibodies and 5.77 L with a range of 2.77 - 10.6 for an increase in anti-pegloticase antibodies.
Maltese: Il-volum tad-distribuzzjoni kien ta' 4.45 L b'firxa ta' 2.625.89 għall-ebda żieda fl-antikorpi kontra pegloticase u ta' 5.77 L b'firxa ta' 2.77 - 10.6 għal żieda flantikorpi kontra pegloticase.
English: Fertility Effect on male and female fertility has not been studied.
Maltese: Fertilità L-effett fuq il-fertilità maskili u femminili ma ġiex studjat.
English: Sodium intake KRYSTEXXA contains 4.2 mg sodium (less than 1 mmol) per dose (essentially sodium free).
Maltese: Konsum ta' sodju KRYSTEXXA fih 4.2 mg ta' sodju (inqas minn 1 mmol) kull doża (essenzjalment ħieles mis-sodju).
English: Disodium hydrogen phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
Maltese: Sodium dihydrogen phosphate dihydrate
English: The average molecular mass of pegloticase is approximately 545 kDa of which the protein moiety constitutes approximately 137 kDa.
Maltese: Il-massa molekulari medja ta' pegloticase hija ta' madwar 545 kDa li minnha l-moiety tal-proteina tikkostitwixxi madwar 137 kDa.
English: The efficacy and safety of KRYSTEXXA was assessed in two replicate Phase III pivotal trials (GOUT 1 and GOUT 2) that were conducted in 212 adult patients with chronic gout refractory to allopurinol.
Maltese: L-effikaċja u s-sigurtà ta' KRYSTEXXA kienu evalwati f'żewġ provi pivotali repliki tal-Fażi III (GOTTA 1 u GOTTA 2) li saru fuq 212-il pazjent adult b'gotta kronika refrattorja għal allopurinol.
English: KRYSTEXXA should not be administered if two consecutive levels above 6 mg/dl (360 µmol/L) have been measured (see section 4.4).
Maltese: KRYSTEXXA ma għandux jingħata jekk ikunu tkejlu żewġ livelli konsekuttivi ogħla minn 6 mg/dl (360 µmol/L) (ara sezzjoni 4.4).
English: Very common: Dermatitis, urticaria, pruritus, skin irritation, dry skin
Maltese: Komuni ħafna: Dermatite, urtikarja, prurite, irritazzjoni tal-ġilda, ġilda xotta Mhux komuni: Ċellulite
English: In clinical trials, 91% of patients who experienced an infusion-related reaction had a serum uric acid level above 6 mg/dl (360 μmol/L) due to the development of anti-pegloticase antibodies.
Maltese: Fil-provi kliniċi, 91% tal-pazjenti li esperjenzaw reazzjoni relatata mal-infużjoni kellhom livell ta' aċidu uriku fis-serum ogħla minn 6 mg/dl (360 μmol/L) minħabba l-iżvilupp ta' antikorpi kontra pegloticase.
English: In the pregnant rat study there was no evidence of embryotoxicity or teratogenicity at 46 times the clinical exposure (AUC).
Maltese: Fl-istudju fuq firien tqal ma kien hemm l-ebda evidenza ta' embrijotossiċità jew teratoġeniċità f'46 darba l-espożizzjoni klinika (AUC).
English: No formal studies were conducted to examine the effects of hepatic impairment.
Maltese: Ma sar l-ebda studju formali biex jeżamina l-effetti tal-indeboliment epatiku.
English: Each vial contains 8 mg of pegloticase (8 mg/ml concentrate).
Maltese: Kull kunjett fih 8 mg ta' pegloticase (8 mg/ml konċentrat).
English: In repeated dose toxicity studies with KRYSTEXXA in rats and dogs, the occurrence of pegloticase-containing vacuoles was observed in different tissues.
Maltese: Fi studji tat-tossiċità tad-dożi ripetuti bi KRYSTEXXA fil-firien u fil-klieb, l-okkorrenza ta' vacuoles li fihom pegloticase kienet osservata f'tessuti differenti.
English: Each vial contains 8 mg of pegloticase (8 mg/ml concentrate)
Maltese: Kull kunjett fih 8 mg ta' pegloticase (8 mg/ml konċentrat)
English: Pegloticase belongs to the class anti-gout medicines.
Maltese: Pegloticase tagħmel parti mill-klassi ta' mediċini kontra l-gotta.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Pharmacotherapeutic group: Anti-gout preparations, other anti-gout preparations, ATC code: M04AX02
Maltese: Taħlit kontra l-gotta, taħlit ieħor kontra l-gotta, Kodiċi ATC:
English: Pegloticase catalyses the conversion of uric acid into the inert highly water-soluble metabolite allantoin, with hydrogen peroxide and carbon dioxide as oxidative by-products.
Maltese: Pegloticase jikkatalizza l-konverżjoni tal-aċidu uriku fil-metabolit inerti li jinħall faċilment fl-ilma allantoin, b'perossidu tal-idroġenu u dijossidu tal-karbonju bħala prodotti sekondarji ossidattivi.
English: • Before administration, the diluted solution of KRYSTEXXA should be allowed to reach room temperature.
Maltese: • Qabel l-għoti, is-soluzzjoni dilwita ta' KRYSTEXXA għandha titħalla tilħaq it-temperatura talkamra.
English: The HAQ-DI scores were 1.1 at baseline vs. 0.84 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 1.2 vs. 1.3 in the placebo group (p≤0.01).
Maltese: Il-punteġġi HAQ-DI kienu ta' 1.1 fil-linja bażi kontra 0.84 fil-Ġimgħa 25 fil-pazjenti li rċevew kura bi pegloticase 8 mg kull ġimgħatejn meta mqabbla ma' 1.2 kontra 1.3 fil-grupp tal-plaċebo (p≤0.01).
English: The most common signs and symptoms of systemic infusion reactions are: urticaria, dyspnoea, flushing, hyperhidrosis, chest discomfort or pain, chills, and hypertension.
Maltese: Is-sinjali u sintomi l-aktar komuni ta' reazzjonijiet sistematiċi għall-infużjoni huma: urtikarja, dispneja, fwawar, iperidrożi, skumdità jew uġigħ fis-sider, tkexkix ta' bard, u ipertensjoni.
English: In the post-marketing setting, severe anaphylactic reactions have been reported, including loss of consciousness, circulatory collapse, and cardiac arrest, which required transfer to hospital emergency department.
Maltese: Fl-esperjenza ta' wara t-tqegħid fis-suq, ġew irrapportati reazzjonijiet anafilattiċi severi, inkluż telf mis-sensi, kollass ċirkolatorju, u arrest kardijaku, li kienu jeħtieġu trasferiment lejn id-dipartiment talemerġenza fi sptar.
English: In the clinical studies, 34% (29 of 85) of patients treated with KRYSTEXXA 8 mg every 2 weeks were 65 years of age and older and 12% (10 of 85) were 75 years of age and older.
Maltese: Fl-istudji kliniċi, 34% (29 minn 85) tal-pazjenti li rċevew kura bi KRYSTEXXA 8 mg kull ġimgħatejn kellhom minn 65 sena 'l fuq u 12% (10 minn 85) kellhom minn 75 sena 'l fuq .
English: No formal studies were conducted to examine the effects of renal insufficiency on pegloticase pharmacokinetics.
Maltese: Ma sar l-ebda studju biex jeżamina l-effetti tal-insuffiċjenza renali fuq il-farmakokinetika ta' pegloticase.
English: To reduce the likelihood of gout flares after initiation of KRYSTEXXA prophylaxis with colchicine or a non-steroidal anti-inflammatory drug (NSAID) is recommended.
Maltese: Biex titnaqqas il-probabbiltà ta' rikaduti tal-gotta wara li jinbeda KRYSTEXXA huwa rakkomandat li ssir profilassi b'colchicine jew b'mediċina antiinfjammatorja mhux sterojdi (NSAID).
English: • 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection for infusion.
Maltese: • 1 ml ta' KRYSTEXXA għandu jiġi injettat ġo borża unika ta' 250 ml ta' klorur tas-sodju ta' 4.5 mg/ml (0.45%) jew ta' 9 mg/ml (0.9%) soluzzjoni għal injezzjoni għal infużjoni.
English: Week 25
Maltese: Ġimgħa 25
English: The primary endpoint in both trials was the proportion of responder patients that achieved plasma uric acid (PUA) less than 0.36 mmol/L (6 mg/dl) for at least 80% of the time during Month 3 and Month 6.
Maltese: Il-punt aħħari primarju fiż-żewġ provi kien il-proporzjon ta' pazjenti li rrispondew li laħqu aċidu uriku fil-plasma (PUA) ta' inqas minn 0.36 mmol/L (6 mg/dl) għal mill-inqas 80% tal-ħin matul Xahar 3 u Xahar 6.
English: In clinical trials, anti-pegloticase antibodies (IgM and IgG) developed in 89% of patients treated with KRYSTEXXA 8 mg every 2 weeks and 15% in the placebo group.
Maltese: Fi provi kliniċi, antikorpi kontra pegloticase (IgM u IgG) żviluppaw f'89% tal-pazjenti li rċevew kura bi KRYSTEXXA 8 mg kull ġimgħatejn u fi 15% fil-grupp tal-plaċebo.
English: Sustained decrease in plasma uric acid below the solubility concentration of 6 mg/dl was observed for more than 12 days with single doses of 8 mg and 12 mg.
Maltese: Kien osservat tnaqqis sostnut fl-aċidu uriku fil-plasma taħt il-konċentrazzjoni ta' solubbilità ta' 6 mg/dl għal aktar minn 12-il jum b'dożi uniċi ta' 8 mg u ta' 12 mg.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet tal-ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Retreatment with KRYSTEXXA
Maltese: Mediċini oħra u KRYSTEXXA
English: The most commonly reported serious side effects are: severe acute allergic reactions (common), infusion reactions (very common), and gout flares (very common).
Maltese: L-effetti sekondarji l-aktar serji komunement irrapportati huma: reazzjonijiet allerġiċi akuti severi (komuni), reazzjonijiet għall-infużjoni (komuni ħafna), u rikaduti tal-gotta (komuni ħafna).
English: The most common signs and symptoms of generalised infusion reactions were: hives, shortness of breath, redness in the face, sweating, chest discomfort or pain, chills, and high blood pressure.
Maltese: Is-sinjali u sintomi l-aktar komuni ta' reazzjonijiet ġeneralizzati għallinfużjoni kienu: urtikarja, qtugħ ta' nifs, ħmura fil-wiċċ, għaraq, skumdità jew uġigħ fis-sider, tkexkix ta' bard, u pressjoni għolja tad-demm.
English: The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4).
Maltese: Id-deċiżjoni li tingħata kura bi KRYSTEXXA għandha tiġi bbażata fuq evalwazzjoni kontinwa talbenefiċċji u tar-riskji għall-pazjent individwali (ara sezzjoni 4.4).
English: Based on similar efficacy and safety profiles of pegloticase in patients with creatinine clearance below and above 50 ml/min, no dose adjustment is required for patients with renal impairment (see section 5.2).
Maltese: Abbażi ta' profili simili ta' effikaċja u ta' sigurtà ta' pegloticase fuq pazjenti bi tneħħija ta' krejatinina inqas u ogħla minn 50 ml/min, ma huwa meħtieġ l-ebda aġġustament tad-doża għal pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: KRYSTEXXA 8 mg concentrate for solution for infusion
Maltese: KRYSTEXXA 8 mg konċentrat għal soluzzjoni għal infużjoni
English: Continuous treatment with pegloticase decreases frequency and intensity of gout flares.
Maltese: Kura kontinwa bi pegloticase tnaqqas il-frekwenza u lintensità ta' rikaduti tal-gotta.
English: KRYSTEXXA, once diluted with 250 ml of sodium chloride solution, 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%), is administered as an intravenous infusion over no less than 2 hours, at a flow rate of approximately 2 ml/minute.
Maltese: KRYSTEXXA, ladarba jiġi dilwit b'250 ml ta' soluzzjoni ta' klorur tas-sodju, 4.5 mg/ml (0.45%) jew 9 mg/ml (0.9%), jingħata bħala infużjoni ġol-vina fuq perjodu ta' mhux inqas minn sagħtejn, b'rata ta' fluss ta' madwar 2 ml/minuta.
English: The HAQ-PGA scores were 42.4 at baseline vs. 27.1 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 51.6 vs. 53.4 in the placebo group (p≤0.001).
Maltese: Il-punteġġi HAQ-PGA kienu ta' 42.4 fil-linja bażi kontra 27.1 fil-Ġimgħa 25 fil-pazjenti li rċevew kura bi pegloticase 8 mg kull ġimgħatejn meta mqabbla ma' 51.6 kontra 53.4 fil-grupp tal-plaċebo (p≤0.
English: The Pain scores using a visual analogue scale were 44.2 at baseline vs. 28.4 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 53.9 vs. 57.2 in the placebo group (p≤0.001).
Maltese: Ilpunteġġi għall-Uġigħ bl-użu ta' skala analoga viżwali kienu ta' 44.2 fil-linja bażi kontra 28.4 filĠimgħa 25 fil-pazjenti li rċevew kura bi pegloticase 8 mg kull ġimgħatejn meta mqabbla ma' 53.9 kontra 57.2 fil-grupp tal-plaċebo (p≤0.
English: Responders maintained PUA values < 6 mg/dl throughout the 6-month treatment period.
Maltese: Pazjenti li rrispondew żammew valuri tal-PUA ta' < 6 mg/dl matul il-perjodu ta' kura ta' 6 xhur.
English: It is unknown whether the development of anti-PEG antibodies may reduce the efficacy of other PEGylated medicinal products.
Maltese: Mhuwiex magħruf jekk l-iżvilupp ta' antikorpi kontra PEG jistgħux inaqqsu l-effikaċja ta' prodotti mediċinali PEGylated oħra.
English: Common side effects (may affect up to 1 in 10 people): high blood sugar levels, vomiting, joint swelling, flu-like symptoms
Maltese: Effetti sekondarji komuni (jistgħu jaffetwaw sa persuna 1 minn kull 10): livelli għoljin ta' zokkor fid-demm, remettar, nefħa fil-ġogi, sintomi bħal tal-influwenza
English: In clinical trials, the percentage of patients that had flares in the first 3 months was 75% in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with 54% in placebo-treated patients.
Maltese: Fi provi kliniċi, il-persentaġġ ta' pazjenti li kellhom rikaduti fl-ewwel 3 xhur kien ta' 75% f'pazjenti li rċevew kura bi KRYSTEXXA 8 mg kull ġimgħatejn meta mqabbla ma' 54% f'pazjenti li rċevew kura bi plaċebo.
English: In clinical trials, the mean plasma uric acid (PUA) levels fell to 0.7 mg/dl approximately 24 hours following the first dose of pegloticase in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with a mean PUA of 8.2 mg/dl in the placebo-treated patients.
Maltese: Fi provi kliniċi, il-livelli medji tal-aċidu uriku fil-plasma (PUA) waqgħu għal 0.7 mg/dl madwar 24 siegħa wara l-ewwel doża ta' pegloticase f'pazjenti li rċevew kura bi KRYSTEXXA 8 mg kull ġimgħatejn meta mqabbla mal-PUA medju ta' 8.2 mg/dl f'pazjenti li rċevew kura bi plaċebo.
English: Concentrate for solution for infusion 1 vial
Maltese: Konċentrat għal soluzzjoni għal infużjoni Kunjett 1
English: Anti-PEG antibodies also developed in 41% of patients treated with KRYSTEXXA 8 mg every 2 weeks.
Maltese: Antikorpi kontra PEG żviluppaw ukoll f'41% tal-pazjenti li rċevew kura bi KRYSTEXXA 8 mg kull ġimgħatejn.
English: Before starting the treatment and especially before monitoring the serum uric acid levels, patients should discontinue oral urate-lowering medication and not institute therapy with oral urate-lowering medication while taking KRYSTEXXA (see section 4.4).
Maltese: Qabel tinbeda t-terapija, u speċjalment qabel il-monitoraġġ tal-livelli tal-aċidu uriku fis-serum, ilpazjenti għandhom jieqfu jieħdu mediċini orali li jnaqqsu l-urate u ma jibdewx terapija b'mediċini orali li jnaqqsu l-urate waqt li jkunu qegħdin jieħdu KRYSTEXXA (ara sezzjoni 4.4).
English: Most infusion-related reactions have been observed after loss of therapeutic response due to the development of anti-pegloticase antibodies, i.e. when serum uric acid values were above 6 mg/dl (360 µmol/L).
Maltese: Ħafna mir-reazzjonijiet relatati mal-infużjoni kienu osservati wara telf ta' rispons terapewtiku minħabba l-iżvilupp ta' antikorpi kontra pegloticase, jiġifieri meta l-valuri tal-aċidu uriku fis-serum kienu ogħla minn 6 mg/dl (360 µmol/L).
English: The mean PUA at baseline was 9.8 mg/dl. Seventy-one percent (71%) of patients had baseline tophi.
Maltese: Wieħed u sebgħin fil-mija (71%) tal-pazjenti kellhom tofi fil-linja bażi.
English: What KRYSTEXXA looks like and contents of the pack
Maltese: Kif jidher KRYSTEXXA u l-kontenut tal-pakkett
English: In controlled clinical trials, the most commonly reported serious adverse reactions were anaphylaxis, which occurred at a frequency of 6.5% (8/123) in patients treated with 8 mg every 2 weeks; infusion reactions, which occurred at a frequency of 26% and gout flares, which were more common during the first 3 months of treatment.
Maltese: Fi provi kliniċi kkontrollati, ir-reazzjonijiet l-aktar avversi serji komunement irrapportati kienu anafilassi, li seħħet bi frekwenza ta' 6.5% (8/123) f'pazjenti li rċevew kura b'8 mg kull ġimgħatejn; reazzjonijiet għall-infużjoni, li seħħew bi frekwenza ta' 26% u rikaduti tal-gotta, li kienu aktar komuni matul l-ewwel 3 xhur tal-kura.
English: Week 19
Maltese: Ġimgħa 19
English: Overall Complete Tophus Resolution (Pooled Analysis of GOUT 1 and GOUT 2)
Maltese: Tabella 3. Riżoluzzjoni Ġenerali Kompluta tat-Tofus (Analiżi Miġbura ta' GOTTA 1 u GOTTA 2)
English: The maximum dose that has been administered as a single intravenous dose during clinical studies was 12 mg. A post-marketing report documented administration of the contents of 2 vials (16 mg) without any adverse reaction related to KRYSTEXXA administration.
Maltese: Rapport wara ttqegħid fis-suq iddokumenta l-għoti tal-kontenut ta' 2 kunjetti (16 mg) mingħajr ebda reazzjoni avversa relatata mal-għoti ta' KRYSTEXXA.
English: The safety and efficacy of KRYSTEXXA in children and adolescents aged below 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' KRYSTEXXA fit-tfal u fl-adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: Week 13
Maltese: Ġimgħa 13
English: Allantoin is eliminated by renal excretion, thereby lowering serum uric acid.
Maltese: Allantoin jiġi eliminat permezz tat-tneħħija mill-kliewi, u b'hekk inaqqas l-aċidu uriku fis-serum.
English: Anti-pegloticase antibodies were associated with an increase in CL and Vc as determined by compartmental analysis.
Maltese: Antikorpi kontra pegloticase kienu assoċjati ma' żieda fis-CL u Vc kif iddeterminat permezz ta' analiżi kompartimentali.
English: The most common signs and symptoms of local infusion reactions were: redness at the injection site, itching, and rash.
Maltese: Is-sinjali u sintomi l-aktar komuni ta' reazzjonijiet lokali għall-infużjoni huma: eritema, prurite, u raxx.
English: The optimal treatment duration has not been established (see section 4.4).
Maltese: It-tul ottimali taż-żmien tal-kura ma ġiex stabbilit (ara sezzjoni 4.4).
English: • The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride and water for injections.
Maltese: • Is-sustanzi l-oħra huma disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, klorur tas-sodju u ilma għall-injezzjonijiet.
English: Uncommon: Exacerbation of congestive heart failure
Maltese: Mhux komuni: Aggravar tal-insuffiċjenza konġestiva tal-qalb
English: • 1 ml of KRYSTEXXA should be withdrawn from the vial into a sterile syringe.
Maltese: • 1 ml ta' KRYSTEXXA għandu jinġibed mill-kunjett ġo siringa sterili.
English: The pharmacokinetics of KRYSTEXXA has not been studied in children and adolescents.
Maltese: Il-farmakokinetika ta' KRYSTEXXA ma ġietx studjata fit-tfal u fl-adolexxenti.