FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of sebelipase alfa in children and adults were determined using a population pharmacokinetic analysis of 65 patients with LAL deficiency who received intravenous infusions of KANUMA at 1 mg/kg once every other week in LAL-CL02.
Maltese: Il-farmakokinetika ta' sebelipase alfa fi tfal u adulti kienet determinata bl-użu ta' analiżi farmakokinetika tal-popolazzjoni ta' 65 pazjent b'defiċjenza ta' LAL li rċivew infużjonijiet fil-vini ta' KANUMA b'doża ta' 1 mg/kg darba kull ġimagħtejn f'LAL-CL02.
English: KANUMA is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.
Maltese: KANUMA hu indikat għal terapija ta' sostituzzjoni tal-enzimi (ERT - enzyme replacement therapy) fit-tul f'pazjenti ta' kull età b'defiċjenza ta' lysosomal acid lipase (LAL).
English: In the spleen, LAL deficiency results in splenomegaly, anemia, and thrombocytopenia.
Maltese: Fil-milsa, defiċjenza ta' LAL twassal għal splenomegalija, anemija, u tromboċitopenija.
English: The difference in exposures to sebelipase alfa between the once weekly 0.35 mg/kg and 3 mg/kg groups was more than dose proportional, with a 8.6-fold increase in dose resulting in a 9.6-fold increase in exposure for AUC and a 10.0-fold increase for Cmax.
Maltese: Id-differenza fl-esponimenti għal sebelipase alfa bejn il-gruppi ta' 0.35 mg/kg u 3 mg/kg darba fil-ġimgħa kienet aktar minn proporzjonali mad-doża, b'żieda ta' 8.6 darbiet fid-doża twassal għal żieda ta' 9.6 darbiet flesponiment għall-AUC u żieda ta' 10.
English: Body temperature increased b,c
Maltese: Żieda fit-temperatura tal-ġisem b,ċ
English: Each vial contains 20 mg of sebelipase alfa in 10 ml (2 mg/ml).
Maltese: Kull kunjett fih 20 mg ta' sebelipase alfa f'10 ml (2 mg/ml).
English: Almac Pharma Services Ltd. Seagoe Industrial Estate Craigavon
Maltese: Seagoe Industrial Estate Craigavon
English: The other ingredients are trisodium citrate dihydrate (see section 2 under ‘KANUMA contains sodium'), citric acid monohydrate, human serum albumin, and water for injections.
Maltese: Is-sustanzi l-oħra huma trisodium citrate dihydrate (ara sezzjoni 2 taħt ‘KANUMA fih sodium'), citric acid monohydrate, serum albumin uman, u ilma għall-injezzjonijiet.
English: Animal studies show no evidence of impaired fertility (see section 5.3).
Maltese: Studji fuq l-annimali ma jurux evidenza ta' fertilità indebolita (ara sezzjoni 5.3).
English: Mechanism of action Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL).
Maltese: Sebelipase alfa huwa lysosomal acid lipase rikombinanti tal-bniedem (rhLAL - recombinant human lysosomal acid lipase).
English: Sebelipase alfa catalyses the lysosomal hydrolysis of cholesteryl esters and triglycerides to free cholesterol, glycerol and free fatty acids.
Maltese: Sebelipase alfa jikkatalizza l-idrolisi lisosomali ta' cholesteryl esters u trigliċeridi f'kolesterol ħieles, glycerol u aċidi grassi ħielsa.
English: Primary Endpoint Normalisation of ALT
Maltese: Punt finali Primarju
English: There are no clinical data on the effects of sebelipase alfa on fertility.
Maltese: M'hemmx dejta klinika dwar l-effetti ta' sebelipase alfa fuq il-fertilità.
English: From baseline to week 48, mean weight-for-age percentile improved from 12.74% to 29.83% and mean serum albumin levels increased from 26.7 g/l to 38.7 g/l.
Maltese: Mil-linja bażi sa ġimgħa 48, il-percentile medju tal-piż tal-ġisem għall-età tjieb minn 12.74% għal 29.83% u l-livelli medji ta' albumina fisserum żdiedu minn 26.
English: This medicinal product contains 33 mg sodium per vial and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Maltese: Dan il-prodott mediċinali fih 33 mg sodium f'kull kunjett u jingħata f'soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) sodium chloride (ara sezzjoni 6.6).
English: See Table 5 for recommended total infusion volumes by weight range.
Maltese: Ara Tabella 5 għall-volumi totali tal-infużjoni rakkomandati skont il-firxa tal-piż.
English: Each vial contains 33 mg sodium.
Maltese: Kull kunjett fih 33 mg ta' sodium.
English: These reported signs and symptoms occurring in two or more patients included abdominal pain, agitation, chills, diarrhoea, eczema, hypertension, irritability, laryngeal oedema, nausea, oedema, pallor, pruritus, pyrexia/body temperature increased, rash, tachycardia, urticaria, and vomiting.
Maltese: Dawn is-sinjali u s-sintomi rrappurtati li seħħew f'żewġ pazjenti jew aktar kienu jinkludu wġigħ addominali, aġitazzjoni, dehxa ta' bard, dijarea, ekżema, pressjoni għolja, irritabilità, edima fil-larinġi, dardir, edima, sfurija, ħakk, deni/żieda fit-temperatura tal-ġisem, raxx, takikardija, urtikarja, u rimettar.
English: After dilution: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C, or up to 12 hours below 25°C.
Maltese: Stabbilità kimika u fiżika waqt l-użu ntweriet sa 24 siegħa f'temperatura ta' 2 °C sa 8 °C, jew sa 12-il siegħa f'temperatura taħt 25 °C.
English: Very common Respiratory distress, wheezing, cough, rhinitis, nasal congestion, sneezing
Maltese: Komuni ħafna Distress respiratorju, tħarħir, sogħla, rinite, konġestjoni fl-imnieħer, għatis
English: Anxietyc, insomnia
Maltese: Ansjetà ċ, insomnja
English: In clinical studies, 21 of 106 (20%) KANUMA-treated patients, including 9 of 14 (64%) infants and 12 of 92 (13%) children and adults, experienced signs and symptoms either consistent with or that may be related to a hypersensitivity reaction.
Maltese: Fi studji kliniċi, 21 minn 106 (20%) pazjenti kkurati b'KANUMA, inkluż 9 minn 14-il (64%) tarbija u 12 minn 92 (13%) tfal u adulti, kellhom sinjali u sintomi konsistenti ma', jew li jistgħu jkunu relatati ma' reazzjoni ta' sensittività eċċessiva.
English: Skin and subcutaneous tissue disorders Very common Urticariab, rashb, eczemab, pruritis, rash maculo-papular
Maltese: Komuni ħafna Urtikarjab, raxxb, ekżemab, ħakk, raxx makulo-papulari
English: Table 1: Adverse reactions reported in infants c receiving KANUMA
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati fi trabi ċ li rċivew KANUMA
English: oedema
Maltese: edima
English: Each vial of 10 ml contains 20 mg sebelipase alfa.
Maltese: Kull kunjett ta' 10 ml fih 20 mg ta' sebelipase alfa.
English: LDL-cholesterol, mean % change from baseline non-HDL-cholesterol, mean % change from baseline Normalisation of AST
Maltese: LDL kolesterol, bidla % medja mil-linja bażi kolesterol mhux HDL, bidla % medja mil-linja bażi Normalizzazzjoni ta' AST
English: Of patients with paired liver biopsies, 63% (10/16) of KANUMA-treated patients had improvement in hepatic steatosis (at least ≥ 5% reduction) as measured by morphometry compared to 40% (4/10) of placebo patients.
Maltese: Mill-pazjenti b'bijopsiji tal-fwied f'pari, 63% (10/16) tal-pazjenti kkurati b'KANUMA kellhom titjib fl-isteatosi tal-fwied (mill-inqas tnaqqis ta' ≥ 5%) kif imkejjel permezz ta' morfometrija meta mqabbel ma' 40% (4/10) tal-pazjenti fuq plaċebo.
English: LAL enzyme activity leads to reductions in liver fat content and transaminases, and enables metabolism of cholesteryl esters and triglycerides in the lysosome, leading to reductions in lowdensity lipoprotein (LDL) cholesterol and non-high-density lipoprotein (HDL) cholesterol, triglycerides, and increases in HDL cholesterol.
Maltese: Sostituzzjoni talattività tal-enzima LAL twassal għal tnaqqis fil-kontenut ta' xaħam fil-fwied u fit-transaminases, u tippermetti l-metaboliżmu ta' cholesteryl esters u trigliċeridi fil-lisosomi, u b'hekk twassal għal tnaqqis fil-kolesterol tal-lipoproteina ta' densità baxxa (LDL - low-density lipoprotein) u fil-kolesterol tal-lipoproteina mhux ta' densità għolja (HDL - high-density lipoprotein), fit-trigliċeridi, u żidiet f'HDL kolesterol.
English: KANUMA at doses up to 1 mg/kg once weekly resulted in improvements in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels and weight gain within the first several weeks of treatment.
Maltese: KANUMA f'dożi sa 1 mg/kg darba fil-ġimgħa wassal għal titjib fil-livelli ta' alanine aminotransferase (ALT) u aspartate aminotransferase (AST) u għal żieda fil-piż fl-ewwel diversi ġimgħat ta' kura.
English: infection of the urinary system swelling of the eyelids temporary increased cholesterol or triglyceride (fats) levels in the blood fast heartbeat anxiety sleeplessness dizziness low blood pressure redness in face shortness of breath swelling of the throat diarrhoea stomach ache stomach bloating nausea hives rash itching red swollen skin increased menstrual bleeding shivers chest discomfort swelling tiredness hardened area around the infusion site fever
Maltese: infezzjoni fis-sistema tal-awrina nefħa tal-kpiepel tal-għajnejn żieda temporanja fil-livelli ta' kolesterol jew trigliċeridi (xaħmijiet) fid-demm taħbit tal-qalb mgħaġġel ansjetà nuqqas ta' rqad sturdament pressjoni baxxa ħmura fil-wiċċ qtugħ ta' nifs nefħa tal-gerżuma dijarea uġigħ fl-istonku nefħa fl-istonku dardir ħorriqija raxx ħakk ġilda ħamra u minfuħa żieda fil-fsada mestrwali tertir skonfort fis-sider nefħa għeja żona iebsa madwar is-sit talinfużjoni deni
English: Based on a noncompartmental analysis of data from adults (LAL-CL01/LAL-CL-04), the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dosages.
Maltese: Ibbażat fuq analiżi mhux kompartimentali ta' dejta minn adulti (LAL-CL01/LAL-CL-04), il farmakokinetika ta' sebelipase alfa dehret li mhix lineari b'żieda akbar minn proporzjonali mad-dożafl-esponiment osservat bejn dożaġġi ta' 1 u 3 mg/kg.
English: In a separate open-label study (LAL-CL01/LAL-CL04) in adult patients with LAL deficiency, improvements in serum transaminase and lipid levels were sustained through the 104-week treatment period.
Maltese: Fi studju open-label separat (LAL-CL01/LAL-CL04) f'pazjenti adulti b'defiċjenza ta' LAL, titjib fillivelli ta' transaminase u tal-lipidi fis-serum kien sostnut tul il-perjodu ta' kura ta' 104 ġimgħat.
English: Of the 32 patients who had a liver biopsy at study entry, 100% had fibrosis and 31% had cirrhosis.
Maltese: Minn 32 pazjent li kellhom bijopsija tal-fwied meta daħlu fl-istudju, 100% kellhom fibrożi u 31% kellhom ċirrożi.
English: In the historical cohort, 0 of 21 patients survived beyond 8 months of age (0% 12-month survival, 95% CI: 0% to
Maltese: Fil-koorti storiku, ħadd (0) minn 21 pazjent ma baqa' ħaj aktar minn 8 xhur (sopravivenza ta' 12-il xahar ta' 0%, CI ta' 95%: 0% sa 16%).
English: KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Maltese: KANUMA għandu jiġi dilwit b'soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) sodium chloride permezz ta' teknika asettika.
English: *Sebelipase alfa is produced in egg white of transgenic Gallus by recombinant DNA (rDNA) technology.
Maltese: *Sebelipase alfa huwa magħmul fl-abjad tal-bajd ta' Gallus transġeniku permezz ta' teknoloġija tattfassil tad-DNA (rDNA - recombinant DNA).
English: During the covariate analysis of the population pharmacokinetics model for sebelipase alfa, age, body weight, and sex were not found to have a significant influence on CL and Vc of sebelipase alfa.
Maltese: Matul l-analiżi kovarjabbli tal-mudell tal-farmakokinetika tal-popolazzjoni għal sebelipase alfa, l-età, il-piż tal-ġisem, u s-sess ma nstabux li għandhom influwenza sinifikanti fuq CL u Vc ta' sebelipase alfa.
English: Paired liver biopsies at baseline and week 20 were available in a subset of patients (n = 26).
Maltese: Bijopsiji tal-fwied f'pari fil-linja bażi u f'ġimgħa 20 kienu disponibbli f'sottogrupp ta' pazjenti (n=26).
English: United Kingdom
Maltese: UNITI TAL-AMERIKA
English: Menorrhagia
Maltese: Menorraġja
English: ≥ 18 years old N=18 Week 0 Week 22* Week 0 Week 22* Week 0 Week 22* AUCss (ng∙hr/mL) 1133.8 941.6 1436.4 1453.6 1989.3 1861.0 Cmax (ng/mL) Tmax (hr) CL (L/hr) Vc (L) T1/2 (hr) * Week 22 for placebo patients reset to Week 0, i.e. first week of active treatment.
Maltese: età ta' ≥ 18-il sena n=18 Ġimgħa 0 Ġimgħa 22* Ġimgħa 0 Ġimgħa 22* Ġimgħa 0 Ġimgħa 22*
English: See Table 1 for recommended total infusion volumes by weight range.
Maltese: Ara Tabella 1 għall-volumi totali tal-infużjoni rakkomandati skont il-firxa tal-piż.
English: Study LAL-CL08: an open-label, Phase 2 study in infants with rapidly progressive LAL Deficiency to explore long-term safety and efficacy data.
Maltese: Studju LAL-CL08: studju open-label, ta' Fażi 2 fi trabi b'Defiċjenza ta' LAL li
English: KANUMA 2 mg/ml concentrate for solution for infusion sebelipase alfa
Maltese: KANUMA 2 mg/ml konċentrat għal soluzzjoni għall-infużjoni sebelipase alfa
English: • Information on how to manage patients experiencing severe hypersensitivity reactions including anaphylaxis.
Maltese: • Informazzjoni dwar kif jiġu mmaniġġjati pazjenti li jkollhom reazzjonijiet severi ta' sensittività eċċessiva inkluż anafilassi.
English: Clear glass vial (Type I) with a siliconised butyl rubber stopper, and an aluminium seal with a plastic flip-off cap, containing 10 ml of concentrate.
Maltese: Kunjett ċar tal-ħġieġ (Tip I) b'tapp tal-lastku butyl silikonizzat, u siġill tal-aluminju b'għatu flip-off tal-plastik, li fih 10 ml ta' konċentrat.
English: * The infusion volume should be based on the prescribed dose and should be prepared to a final sebelipase alfa concentration of 0.1-1.5 mg/ml.
Maltese: * Il-volum tal-infużjoni għandu jkun ibbażat fuq id-doża preskritta u għandu jiġi ppreparat sa konċentrazzjoni finali ta' sebelipase alfa ta' 0.1-1.5 mg/ml.
English: There is limited information on the impact of anti-drug antibodies on sebelipase alfa pharmacokinetics.
Maltese: Hemm informazzjoni limitata dwar l-impatt ta' antikorpi kontra l-mediċina fuq il-farmakokinetika ta' sebelipase alfa.
English: Infants presenting with LAL deficiency
Maltese: Reġistru ta' defiċjenza ta' LAL
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 2 mg sebelipase alfa*.
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 2 mg sebelipase alfa*.
English: This medicine may contain egg proteins.
Maltese: Din il-mediċina jista' jkun fiha proteini mill-bajd.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg sebelipase alfa in 10 ml of solution (2 mg/ml)
Maltese: Kull kunjett fih 20 mg ta' sebelipase alfa f'10 ml ta' soluzzjoni (2 mg/ml)
English: The data in Table 2 describe adverse reactions reported in children and adults who received sebelipase alfa in clinical studies at a dose of 1 mg/kg once every other week.
Maltese: Id-dejta f'Tabella 2 tiddeskrivi reazzjonijiet avversi rrappurtati fi tfal u adulti li rċivew sebelipase alfa fi studji kliniċi b'doża ta' 1 mg/kg darba kull ġimagħtejn.
English: LAL deficiency presenting in infants is a medical emergency with rapid disease progression over a period of weeks that is typically fatal within the first 6 months of life.
Maltese: Defiċjenza ta' LAL fit-trabi hija emerġenza medika bi progressjoni rapida tal-marda fuq perjodu ta' ġimgħat li tipikament hija fatali fi żmien lewwel 6 xhur tal-ħajja.
English: These medicines may include antihistamines, fever-reducing medicines and/or corticosteroids (a type of antiinflammatory medicines).
Maltese: Dawn il-mediċini jistgħu jinkludu antistamini, mediċini li jnaqqsu d-deni u/jew kortikosterojdi (tip ta' mediċina li taħdem kontra l-infjammazzjoni).
English: Urticaria, rashc,e (including rash papular and rash pruritic), prurituse, eczema e
Maltese: (inkluż raxx bl-infafet u raxx bil-ħakk), ħakk e, ekżema e
English: The educational material is aimed to encourage healthcare professionals to enrol patients in the prospective disease and clinical outcome registry of patients with Lysosomal Acid Lipase (LAL) Deficiency to monitor for efficacy and safety of Kanuma (LAL Deficiency Registry), with particular regard to hypersensitivity reactions, including anaphylaxis, and anti-drug antibodies (ADA) development impacting response to drug.
Maltese: Il-materjal edukattiv huwa mmirat biex jinkoraġġixxi professjonisti fil-kura tas-saħħa biex idaħħlu lpazjenti fir-reġistru ta' mard prospettiv u ta' riżultat kliniku ta' pazjenti b'Defiċjenza ta' Lysosomal Acid Lipase (LAL) biex jiġu ssorveljati l-effikaċja u s-sigurtà ta' Kanuma (Reġistru ta' Defiċjenza ta' LAL), b'attenzjoni partikolari għal reazzjonijiet ta' sensittività eċċessiva, inkluż anafilassi, u żvilupp ta' antikorpi kontra l-mediċina (ADA - anti-drug antibodies) b'impatt fuq ir-rispons għall-mediċina.
English: LAL-CL03 was a multicentre, open-label, single-arm study of KANUMA in 9 patients with LAL deficiency with growth failure or other evidence of rapidly progressive disease prior to 6 months of age.
Maltese: LAL-CL03 kien studju multiċentriku, open-label, bi grupp wieħed dwar KANUMA f'9 pazjenti b'defiċjenza ta' LAL b'insuffiċjenza tat-tkabbir jew b'evidenza oħra ta' marda li qed tavvanza malajr qabel l-età ta' 6 xhur.
English: Very common Diarrhoea, gastro-oesophageal reflux disease, retching, vomiting b
Maltese: Komuni ħafna Dijarea, marda ta' rifluss gastroesofagali, tqalligħ, rimettar b
English: Each ml of concentrate contains 2 mg sebelipase alfa.
Maltese: Kull ml ta' konċentrat fih 2 mg sebelipase alfa.
English: Twenty-four patients were aged 411 years, 23 were aged 12-17 years, and 18 were aged ≥ 18 years (Table 4).
Maltese: Erbgħa u għoxrin pazjent kellhom età ta' 4-11-il sena, 23 kellhom età ta' 12-17-il sena, u 18 kellhom età ta' ≥ 18-il sena (Tabella 4).
English: Sebelipase alfa is similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body uses to breakdown fats.
Maltese: Sebelipase alfa huwa simili għall-enzima li sseħħ b'mod naturali lysosomal acid lipase (LAL), li l-ġisem juża biex ikisser ix-xaħmijiet.
English: Aseptic technique should be used.
Maltese: Għandha tintuża teknika asettika.
English: Patients were randomised to receive KANUMA at a dose of 1 mg/kg (n = 36) or placebo (n = 30) once every other week for 20 weeks in the double-blind period.
Maltese: Il-pazjenti kienu mqassma b'mod każwali biex jirċievu KANUMA b'doża ta' 1 mg/kg (n=36) jew plaċebo (n=30) darba kull ġimagħtejn għal 20 ġimgħa fil-perjodu double-blind.
English: The data in Table 1 describe adverse reactions reported in infants who received KANUMA in clinical studies at doses up to 3 mg/kg weekly.
Maltese: Id-dejta f'Tabella 1 tiddeskrivi reazzjonijiet avversi rrappurtati fi trabi li rċivew KANUMA fi studji kliniċi f'dożi sa 3 mg/kg kull ġimgħa.
English: , abdominal pain b,e abdominal distension, nausea b e
Maltese: , nefħa addominali, dardir b e
English: Chronic toxicity studies in juvenile cynomolgous monkeys showed no toxicity at doses up to 3 times the recommended dose in infants and 10 times the recommended dose in adults/children.
Maltese: Studji dwar it-tossiċità kronika f'xadini cynomolgous ġovenili ma wrew l-ebda tossiċità b'dożi sa 3 darbiet id-doża rakkomandata fit-trabi u 10 darbiet id-doża rakkomandata fl-adulti/tfal.
English: Prior to launch of Kanuma in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational material including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel ma Kanuma jitqiegħed fis-suq f'kull Stat Membru, il-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH - Marketing Authorisation Holder) għandu jiftiehem dwar il-kontenut u ddisinn tal-materjal edukattiv inkluż mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Interim reports expected yearly
Maltese: Rapporti interim mistennija kull sena
English: LAL deficiency is a rare disease associated with significant morbidity and mortality, which affects individuals from infancy through adulthood.
Maltese: Defiċjenza ta' LAL hija marda rari assoċjata ma' morbidità u mortalità sinifikanti, li taffettwa individwi minn meta jkunu trabi sa matul l-istat adult.
English: Because it is a recombinant human protein, sebelipase alfa is an unlikely candidate for cytochrome P450 mediated or other drug-drug interactions.
Maltese: Peress li huwa proteina rikombinanti umana, sebelipase alfa x'aktarx li mhux kandidat għall-interazzjonijiet bejn mediċina u oħra medjati miċ-ċitokroma P450 jew għall-interazzjonijiet oħrajn bejn mediċina u oħra.
English: See section 5.2.
Maltese: Ara sezzjoni 5
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance when attempts to rechallenge are unsuccessful, or to egg or any of the excipients listed in section 6.1, (see section 4.4).
Maltese: Sensittività eċċessiva ta' theddida għall-ħajja (reazzjoni anafilattika) għas-sustanza attiva meta tentattivi biex jingħata mill-ġdid ma jirnexxux, jew għall-bajd jew għal kwalunkwe wieћed milleċċipjenti elenkati fis-sezzjoni 6.1 (ara sezzjoni 4.4).
English: For instructions on the preventive measures and monitoring of hypersensitivity reactions, see section 4.4.
Maltese: Għal struzzjonijiet dwar miżuri preventivi u l-monitoraġġ ta' reazzjonijiet ta' sensittività eċċessiva, ara sezzjoni 4.4.
English: Very common Eyelid oedema
Maltese: Kunjett wieħed
English: • Warning and precautions on the the risk of hypersensitivity including anaphylaxis or ADA development, with particular reference to symptoms, time to onset and severity.
Maltese: • Twissija u prekawzjonijiet dwar ir-riskju ta' sensittività eċċessiva inkluż anafilassi jew żvilupp ta' ADA, b'referenza partikolari għal sintomi, ħin biex jibdew u severità.
English: Sixty-five of 66 patients entered the open-label period (up to 130 weeks) at a KANUMA dose of 1 mg/kg once every other week.
Maltese: Ħamsa u sittin minn 66 pazjent daħlu fil-perjodu open-label (sa 130 ġimgħa) b'doża ta' KANUMA ta' 1 mg/kg darba kull ġimagħtejn.
English: The most serious adverse reactions experienced by 3% of patients in clinical studies were signs and symptoms consistent with anaphylaxis.
Maltese: Ir-reazzjonijiet avversi l-aktar serji esperjenzati minn 3% tal-pazjenti fl-istudji kliniċi kienu sinjali u sintomi konsistenti ma' anafilassi.
English: LAL deficiency is an autosomal recessive lysosomal storage disorder characterised by a genetic defect resulting in a marked decrease or loss in activity of the lysosomal acid lipase (LAL) enzyme.
Maltese: Defiċjenza ta' LAL hija disturb awtosomali riċessiv fil-ħażna tal-lisosomi kkaratterizzat minn difett ġenetiku li jwassal għal tnaqqis jew telf sostanzjali fl-attività tal-enzima lysosomal acid lipase (LAL).
English: Laryngeal oedema e, dyspnoea b,c,e
Maltese: , uġigħ addominali b,e
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of sebelipase alfa.
Maltese: Konsegwentement, indeboliment fil-funzjoni tal-fwied mhux mistenni li jaffettwa lfarmakokinetika ta' sebelipase alfa.
English: Two patients were determined to be positive for antibodies that inhibit in vitro enzyme activity and cellular uptake of the enzyme.
Maltese: Żewġ pazjenti kienu determinati li huma pożittivi għall-antikorpi li jinibixxu l-attività in vitro tal-enzima u t-teħid ċellulari tal-enzima.
English: Dose escalation to 3 mg/kg once weekly was associated with additional improvements in weight gain, lymphadenopathy and serum albumin.
Maltese: Żieda fid-doża għal 3 mg/kg darba fil-ġimgħa kienet assoċjata ma' titjib addizzjonali fiż-żieda fil-piż, limfadenopatija u albumina fis-serum.
English: The management of hypersensitivity reactions may include temporarily interrupting the infusion, lowering the infusion rate, and/or treatment with antihistamines, antipyretics, and/or corticosteroids.
Maltese: L-immaniġġjar ta' reazzjonijiet ta' sensittività eċċessiva jista' jinkludi interruzzjoni temporanja talinfużjoni, tnaqqis tar-rata tal-infużjoni, u/jew kura b'antistamini, sustanzi kontra d-deni, u/jew kortikosterojdi.
English: Chills, chest discomfort c,e
Maltese: Urtikarja, raxx ċ,e