FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall summary of the scientific evaluation of Tobramycin VVB and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' Tobramycin VVB u ismijiet assoċjati (ara Anness I)
English: On day 210, major issues on safety and efficacy were raised which remained unsolved; hence the procedure was referred to the CMDh, under Article 29, paragraph 1 of Directive 2001/83/EC by Lithuania on 24 July 2015.
Maltese: Fil-jum 210, tqajmu kwistjonijiet maġġuri dwar is-sigurtà u l-effikaċja li baqgħu ma ssolvewx; għaldaqstant il-proċedura ġiet riferuta lis-CMDh, skont l-Artikolu 29, il-paragrafu 1 tad-Direttiva 2001/83/KE mill-Litwanja fll-24 ta' Lulju 2015.
English: Poland considered that the clinical superiority of Tobramycin VVB vs. the orphan-designated medicinal product TOBI Podhaler 28 mg inhalation powder (hereinafter “TOBI Podhaler”) was not demonstrated, therefore derogation as per Article 8(3) of Regulation (EC) No 141/2000 was not fulfilled and a marketing authorisation as proposed by the RMS could not be granted.
Maltese: Il-Polonja qieset li s-superjorità klinika ta' Tobramycin VVB kontra l-prodott mediċinali ddisinjat bħala orfni TOBI Podhaler 28 mg trab għall-inalazzjoni (minn hawn 'il quddiem "TOBI Podhaler") ma ntweritx, għaldaqstant deroga skont l-Artikolu 8(3) tar-Regolament (KE) Nru 141/2000 ma ġietx issodisfata u l-awtorizzazzjoni għat-tqegħid fis-suq kif proposta mir-RMS ma setgħetx tingħata.
English: To substantiate the relevance of difference in the incidence of adverse events (e.g. cough, discontinuation, etc.) between Tobramycin VVB and the orphan-designated medicinal product TOBI Podhaler based on own and/or published data.
Maltese: Sabiex jissostanzja r-relevanza tad-differenza fl-inċidenza ta' avvenimenti avversi (eż. sogħla, twaqqif, eċċ.) bejn Tobramycin VVB u l-prodott mediċinali ddeżinjat orfni TOBI Podhaler abbażi ta' data proprja u/jew ippubblikata.
English: Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial.
Maltese: Sigurtà, effikaċja u konvenjenza ta' tobramycin trab għall-inalazzjoni f'pazjenti bil-fibrożi ċistika:
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the claim for clinical superiority of Tobramycin VVB vs. TOBI Podhaler;
Maltese: • Il-Kumitat irrieżamina r-risponsi sottomessi mill-applikant sabiex jindirizza l-kwistjonijiet imqajma fir-rigward tal-istqarrija ta' superjorità klinika ta' Tobramycin VVB kontra TOBI Podhaler;
English: Post hoc analysis of AEs profile in different age groups confirmed the results that were originally observed in EAGER study, i.e., any AE and cough, dysphonia and dysgeusia were more frequent among TIP-treated patients across all age groups.
Maltese: Analiżi post hoc tal-profil tal-AEs fi gruppi tal-eta differenti kkonfermat ir-riżultati li kienu osservati oriġinarjament fl-istudju EAGER, jiġifieri kwalunkwe AE u sogħla, disfonija u disgewsja kienu aktar frekwenti fost il-pazjenti kkurati bit-TIP tul il-gruppi tal-età kollha.
English: Tobramycin inhalation powder in cystic fibrosis patients: response by age group.
Maltese: Skont ir-Reġistru tal-Pazjenti tas-Soċjetà Ewropea dwar il-Fibrożi Ċistika (European Cystic Fibrosis Society Patient
English: Therefore the CHMP concluded that the clinical relevance of the abovementioned differences between Tobramycin VVB and TOBI Podhaler demonstrates the clinical superiority of Tobramycin VVB over TOBI Podhaler based on greater safety in a substantial portion of the target population.
Maltese: Għaldaqstant, is-CHMP ikkonkluda li r-relevanza klinika tad-differenzi imsemmija hawn fuq bejn Tobramycin VVB u TOBI Podhaler turi s-superjorità klinika ta' Tobramycin VVB fuq TOBI Podhaler abbażi tas-sigurtà akbar f'parti sostanzjali tal-popolazzjoni fil-mira.
English: Day 60 of the CMDh procedure was on 01 October 2015 and since the Member States failed to reach an agreement, the procedure was referred to the CHMP in accordance with Article 29(4) of Directive 2001/83/EC.
Maltese: Il-jum 60 tal-proċedura tas-CMDh kien fl-1 ta' Ottubru 2015 u peress li l-Istati Membri naqsu milli jilħqu qbil, il-proċedura ġiet riferuta lis-CHMP skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE.
English: When taken together, these elements allow to estimate that at least 10% of the target population may not be able to use TOBI Podhaler due to intolerance.
Maltese: Meta jittieħdu flimkien, dawn l-elementi jippermettu li jiġi stmat li mill-anqas 10% tal-popolazzjoni filmira ma tkunx tista' tuża TOBI Podhaler minħabba l-intolleranza.
English: Cough (not including productive cough) was the most frequently reported AE throughout the entire study period (TIP: 48.4%; TIS: 31.1%) despite being present in the same proportion of patients (42%) in both groups as a baseline symptom.
Maltese: Sogħla (sogħla produttiva mhux inkluża) kienet l-aktar AE rrapportat frekwenti matul ilperjodu kollu tal-istudju (TIP: 48.4%; TIS:
English: The importance of cough as AE for a powder formulation was already acknowledged during the assessment of TOBI Podhaler, and it is recommended that alternative treatment with the nebuliser solution is considered for patients using TOBI Podhaler who experience continued therapy-induced cough.
Maltese: L-importanza tas-sogħla bħala AE għal formulazzjoni tat-trab kienet digà rikonoxxuta waqt il-valutazzjoni ta' TOBI Podhaler, u huwa rrakkomandat li kura alternattiva bis-soluzzjoni għan-nebulizzatur titqies għal pazjenti li qed jużaw TOBI Podhaler li jesperjenzaw sogħla kontinwa minħabba l-kura.
English: However, CHMP concluded that these differences are not relevant in the context of the claim of clinical superiority based on greater safety as the patients constituting a substantial portion of the target population are intolerant to Tobi Podhaler and cannot use therefore Tobi Podhaler.
Maltese: Madankollu, is-CHMP ikkonkluda li dawn id-differenzi mhumiex relevanti fil-kuntest tal-istqarrija tas-superjorità klinika abbażi ta' sigurtà akbar minħabba li l-pazjenti li jikkostitwixxu parti sostanzjali tal-popolazzjoni fil-mira huma intolleranti għal Tobi Podhaler u għaldaqstant ma jistgħux jużaw Tobi Podhaler.
English: • The Committee therefore considered that, in the context of Article 8(3) of Regulation (EC) No 141/2000, clinical superiority of Tobramycin VVB over TOBI Podhaler in a substantial portion of the target population can be established.
Maltese: • Għaldaqstant il-Kumitat ikkunsidra li, fil-kuntest tal-Artikolu 8(3) tar-Regolament (KE) Nru 141/2000, is-superjorità klinika ta' Tobramycin VVB fuq TOBI Podhaler f'parti sostanzjali talpopolazzjoni fil-mira tista' tkun stabbilita.
English: Local respiratory intolerability to the dry powder inhalation can manifest itself through symptoms such as cough, and result in discontinuation of treatment.
Maltese: Intollerabbiltà respiratorja lokali għall-inalazzjoni tat-trab xott tista' tidher permezz ta' sintomi bħassogħla, u tirriżulta fi twaqqif tal-kura.
English: With regards to the claim of clinical superiority on the ground of greater safety in a substantial portion of the target population, the applicant was requested by CHMP during the procedure:
Maltese: Fir-rigward tal-istqarrija ta' superjorità klinika għar-raġuni ta' sigurtà akbar f'parti sostanzjali talpopolazzjoni fil-mira, l-applikant kien mitlub mis-CHMP waqt il-proċedura:
English: Strength Pharmaceutical Form
Maltese: Isem ivvintat Qawwa Għamla farmaċewtika
English: Immediate packaging Pack size
Maltese: Il-pakkett li jmiss mal-prodott
English: Route of administration
Maltese: Daqs talpakkett
English: EMA/732937/2010 EMEA/V/C/002233
Maltese: EMEA/V/C/002233
English: It is available as chewable tablets in five strengths (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) for dogs and cats and in three additional strengths for larger dogs (665 mg, 1040 mg and 1620 mg).
Maltese: Jiġi f'pilloli li jintmagħdu, f'ħames qawwiet (90 mg, 140 mg, 180 mg, 270 mg, 425 mg), għall-klieb u l-qtates u fi tliet qawwiet addizzjonali għallklieb akbar (665 mg, 1040 mg u 1620 mg).
English: Comfortis is a veterinary medicine that contains spinosad.
Maltese: Comfortis huwa mediċina veterinarja li fiha s-spinosad.
English: The studies involved dogs and cats of different age groups, genders, breeds and weights.
Maltese: Listudji involvew klieb u qtates minn gruppi ta' età, sess, razez u piżijiet differenti.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Comfortis on 11/02/2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Comfortis fl-11/02/2011.
English: In the clinical studies, Comfortis was compared with a veterinary medicine authorised in the EU for the treatment and prevention of flea infestations (selamectin, a ‘spot-on' applied to the skin of the dog or cat).
Maltese: Fl-istudji kliniċi Comfortis tqabbel ma' mediċina veterinarja awtorizzata fl-UE għall-kura u l-prevenzjoni ta' infestazzjonijiet bil-briegħed (selamestin, ‘spot-on' applikat fuq il-ġilda tal-kelb jew tal-qattus).
English: The active substance in Comfortis, spinosad, is an insecticide which works by interfering with certain receptors (nicotinic acetylcholine receptors) in the fleas' nervous system, which results in their subsequent paralysis and death.
Maltese: Is-sustanza attiva f'Comfortis, is-spinosad, hija insettiċida li taħdem billi tinterferixxi f'ċerti riċetturi (riċetturi nikotiniċi tal-aketilkolina) fis-sistema nervuża tal-briegħed, u dan jikkaġunalhom paraliżi u mbagħad il-mewt.
English: What is Comfortis?
Maltese: X'inhu Comfortis?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid iktar informazzjoni relatata mar-rakkomandazzjonijiet tasCVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: Why has Comfortis been approved?
Maltese: Għaliex ġie approvat Comfortis?
English: How has Comfortis been studied?
Maltese: Kif ġie studjat Comfortis?
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Ilbilanċ tal-benefiċċju-riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Comfortis tablets are not recommended for use in dogs weighing less than 1.3 kg or in cats weighing less than 1.2 kg (as accurate dosing of the product in such small dogs or cats is not possible and they may be accidentally overdosed).
Maltese: Mhux irrakkomandat li l-pilloli Comfortis jintużaw fi klieb li jiżnu inqas minn 1.3 kg jew fi qtates li jiżnu inqas minn 1.2 kg (minħabba li dożaġġ preċiż tal-prodott fi klieb jew qtates tant żgħar mhuwiex possibbli u jistgħu aċċidentalment jingħataw doża eċċessiva).
English: What is the risk associated with Comfortis?
Maltese: X'inhu r-riskju assoċjat ma' Comfortis?
English: Comfortis can also be used as part of a treatment strategy for flea allergic dermatitis (an allergic reaction to flea bites).
Maltese: Comfortis jista' jintuża wkoll bħala parti mill-istrateġija ta' kura għal dermatite allerġika tal-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: Use of Comfortis tablets in dogs or cats which have epilepsy may involve additional risks.
Maltese: L-użu tal-pilloli Comfortis fi klieb jew qtates li għandhom l-epilessija jista' jinvolvi riskji addizzjonali.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan il-prodott tista' tinstab fuq it-tikketta/il-pakkett ta' barra.
English: The medicine starts killing fleas on the dog or cat 30 minutes after giving the tablet(s) and it remains active for up to four weeks.
Maltese: Il-mediċina tibda toqtol il-briegħed fuq il-kelb jew il-qattus fi żmien 30 minuta minn meta jingħataw il-pillola(i) u tibqa' attiva sa erba' ġimgħat wara.
English: Accidental ingestion, including by children, may cause adverse reactions.
Maltese: Inġestjoni aċċidentali, inkluż mit-tfal, tista' tikkawża reazzjonijiet avversi.
English: The studies also showed that the preventive effect of spinosad against new flea infestations (which results from its residual insecticidal activity) lasts for up to 4 weeks.
Maltese: L-istudji wrew ukoll li l-effett ta' prevenzjoni tas-spinosad kontra l-infestazzjonijiet ġodda bil-briegħed (li jirriżulta mill-attività residwa tal-insettiċida) idum sa 4 ġimgħat.
English: Comfortis has been studied in laboratory animals, as well as in dogs or cats that were treated in various veterinary practices and clinics across Europe (“clinical studies”).
Maltese: Comfortis ġie studjat fuq annimali f'laboratorju kif ukoll fuq klieb jew qtates li jkunu ngħataw kura f'diversi prattiki u kliniċi veterinarji fl-Ewropa kollha (“studji kliniċi”).
English: The CVMP concluded that the benefits of Comfortis outweigh the risks when used for the approved indications and recommended that Comfortis be given a marketing authorisation.
Maltese: Is-CVMP iddeċieda li l-benefiċċji ta' Comfortis huma akbar mir-riskji tiegħu meta jintuża għallindikazzjonijiet approvati u rrakkomanda li Comfortis jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Studies also showed that the frequency and severity of flea allergy dermatitis (an allergic reaction to flea bites) is significantly decreased in dogs and cats treated with Comfortis and so its use as part of a treatment strategy for the control of this condition is justified.
Maltese: L-istudji wrew ukoll li l-frekwenza u s-serjetà tad-dermatite allerġika tal-briegħed (reazzjoni allerġika għall-gdim tal-briegħed) titnaqqas b'mod sinifikanti fi klieb u qtates ittrattati b'Comfortis, u li għalhekk l-użu tiegħu bħala parti mill-istrateġija tat-trattament għall-kontroll ta' din il-kundizzjoni huwa ġġustifikat.
English: Comfortis is used to treat and prevent flea infestations in dogs and cats.
Maltese: Comfortis jintuża biex jikkura u jipprevjeni infestazzjonijiet tal-briegħed fil-klieb u l-qtates.
English: Placebo (n = 30)
Maltese: Plaċebo (n=30)
English: Human serum albumin
Maltese: Serum albumin uman
English: 12-17 years old N=23
Maltese: età ta' 12-17-il sena n=23
English: P-value d
Maltese: Valur p d
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fi friġġ (2 °C sa 8 °C).
English: Diarrhoea b,e
Maltese: Dijarea b,e
English: Secondary Endpoints
Maltese: Punti finali Sekondarji
English: Very common Agitation b, irritability b
Maltese: Komuni ħafna Aġitazzjoni b, irritabilità b
English: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA United Kingdom
Maltese: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA
English: Total infusion volume (ml)
Maltese: Volum totali tal-infużjoni (ml)
English: Fujifilm Diosynth Biotechnologies USA Inc 6051 George Watts Hill Drive Research Triangle Park North Carolina
Maltese: Inc 6051 George Watts Hill Drive Research Triangle Park North Carolina
English: MedDRA preferred term
Maltese: Terminu ppreferut MedDRA
English: KANUMA contains sodium
Maltese: KANUMA fih sodium
English: Table 3: Primary and secondary efficacy endpoints in LAL-CL02 Endpoint
Maltese: Tabella 3: Punti finali primarji u sekondarji tal-effikaċja f'LAL-CL02
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1033/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1033/001
English: This medicine is an enzyme replacement therapy.
Maltese: Din il-mediċina hija terapiji ta' sostituzzjoni ta' enzimi.
English: PC: {number} SN: {number} NN: {number}
Maltese: X'għandek tkun taf qabel ma jingħata KANUMA
English: The active substance is sebelipase alfa.
Maltese: Is-sustanza attiva hi sebelipase alfa.
English: Lysosomal acid lipase (LAL) deficiency
Maltese: Defiċjenza ta' lysosomal acid lipase (LAL)
English: Open-label period
Maltese: Perjodu open-label
English: P-values are from Fisher's exact test for normalisation endpoints and Wilcoxon rank-sum test for all other endpoints.
Maltese: d Valuri p huma mit-test eżatt ta' Fisher (Fisher's exact test) għall-punti finali tan-normalizzazzjoni u mit-test Wilcoxon rank-sum għall-punti finali l-oħra kollha.
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ilfrekwenzi huma definiti skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: LAL-CL02 was a multicentre, double-blind, placebo-controlled study in 66 children and adults with LAL deficiency.
Maltese: LAL-CL02 kien studju multiċentriku, double-blind u kkontrollat bil-plaċebo f'66 tfal u adulti b'defiċjenza ta' LAL.
English: Common side effects reported in children and adolescents (4 to 18 years old) and adults are: severe allergic reaction (anaphylactic reaction)
Maltese: Effetti sekondarji komuni irrappurtati fi tfal u adolexxenti (età minn 4 snin sa 18-il sena) u adulti huma: reazzjoni allerġika severa (reazzjoni anafilattika)
English: Table 4: Mean Population Pharmacokinetic Parameters
Maltese: Tabella 4: Parametri Medji tal-Farmakokinetika tal-Popolazzjoni
English: Trisodium citrate dihydrate Citric acid monohydrate Human serum albumin Water for injections
Maltese: Trisodium citrate dihydrate Citric acid monohydrate Serum albumin uman
English: MedDRA System organ class
Maltese: Klassi tas-Sistemi u tal-Organi
English: Children and adults
Maltese: Tfal u adulti
English: Sebelipase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Maltese: Sebelipase alfa huwa proteina u huwa mistenni li jiġi metabolikament degradat permezz ta' idrolisi talpeptidi.
English: T1/2 = Half-life
Maltese: T1/2 (siegħa)
English: Each 10 ml vial contains 33 mg sodium.
Maltese: Kull kunjett ta' 10 ml fih 33 mg sodium.
English: KANUMA should be administered through a 0.2 μm filter (see section 6.6).
Maltese: KANUMA għandu jingħata minn ġo filtru ta' 0.2 μm (ara sezzjoni 6.6).
English: Transient hyperlipidaemia
Maltese: Iperlipidimja temporanja
English: Patients have developed anti-drug antibodies (ADA) to sebelipase alfa.
Maltese: Pazjenti żviluppaw antikorpi kontra l-mediċina (ADA - anti-drug antibodies) għal sebelipase alfa.
English: Table 1: Recommended infusion volumes (1 mg/kg dose)* Weight range (kg)
Maltese: Tabella 1: Volumi tal-infużjoni rakkomandati (doża ta' 1 mg/kg)* Firxa tal-piż (kg)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI awi 28, 2015
English: In LAL-CL03, sebelipase alfa was eliminated from the systemic circulation with a median T1/2 of 0.1 hr (range: 0.1-0.2) at the 3 mg/kg once weekly dose (n = 4).
Maltese: F'LAL-CL03, sebelipase alfa kien eliminat miċ-ċirkolazzjoni sistemika b'T1/2 medjana ta' 0.1 siegħa (firxa: 0.1-0.2) bid-doża ta' 3 mg/kg darba fil-ġimgħa (n = 4).
English: Elderly population (≥ 65 years old)
Maltese: Popolazzjoni anzjana (età ta' ≥ 65 sena)
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes; ATC code: not yet assigned
Maltese: Prodotti oħra tal-passaġġ alimentari u tal-metaboliżmu, Enzimi; Kodiċi ATC: mhux assenjat
English: Very common Tachycardia b
Maltese: Komuni ħafna Takikardija b
English: Fifty-six of 84 patients (67%) who received sebelipase alfa during clinical studies (LAL-CL01/LALCL04, LAL-CL02 and LAL-CL03) were in the paediatric and adolescent age range (1 month up to 18 years).
Maltese: Sitta u ħamsin minn 84 pazjent (67%) li rċivew sebelipase alfa waqt l-istudji kliniċi (LAL-CL01/LALCL04, LAL-CL02 u LAL-CL03) kienu fil-firxa ta' età pedjatrika u adolexxenti (minn xahar sa 18-il sena).
English: KANUMA contains the active substance sebelipase alfa.
Maltese: KANUMA fih is-sustanza attiva sebelipase alfa.
English: Study LAL-CL02 - Children and Adults 1 mg/kg once every other week
Maltese: Studju LAL-CL02 - Tfal u Adulti 1 mg/kg darba kull ġimagħtejn età ta' 4-11-il sena n=24
English: The following endpoints were assessed: normalisation of ALT, decrease in LDL-cholesterol, decrease in non-HDL-cholesterol, normalisation of AST, decrease in triglycerides, increase in HDLcholesterol, decrease in liver fat content assessed by multi-echo gradient echo magnetic resonance imaging (MEGE-MRI), and improvement in hepatic steatosis measured by morphometry.
Maltese: Kienu evalwati l-punti finali li ġejjin: normalizzazzjoni ta' ALT, tnaqqis f'LDL kolesterol, tnaqqis filkolesterol mhux HDL, normalizzazzjoni ta' AST, tnaqqis fit-trigliċeridi, żieda f'HDL kolesterol, tnaqqis fil-kontenut ta' xaħam fil-fwied stmat permezz ta' multi-echo gradient echo magnetic resonance imaging (MEGE-MRI), u titjib fl-isteatosi epatika mkejla permezz ta' morfometrija.
English: Transient hypercholesterolaemia, transient hypertriglyceridaemia
Maltese: Iperkolesterolimja temporanja, ipertrigliċeridemija temporanja
English: Proportion of patients who achieved normalisation defined as 34-59 U/l, depending on age and gender.
Maltese: Proporzjon ta' pazjenti li kisbu normalizzazzjoni definita bħala 34-59 U/l, skont l-età u s-sess.
English: b. It is recommended to allow KANUMA vials to reach a temperature between 15°C and 25°C prior to reconstitution to minimize the potential for the formation of sebelipase alfa protein particles in solution.
Maltese: Huwa rakkomandat li l-kunjetti ta' KANUMA jitħallew jilħqu temperatura bejn 15°C u 25°C qabel ir-rikostituzzjoni biex jiġi minimizzat il-potenzjal ta' formazzjoni ta' partiċelli ta' proteini ta' sebelipase alfa fis-soluzzjoni.
English: There is limited information of sebelipase alfa pharmacokinetics in non-Caucasian ethnic groups.
Maltese: Hemm informazzjoni limitata dwar il-farmakokinetika ta' sebelipase alfa fi gruppi etniċi mhux Kawkasi.
English: Infants (< 6 months of age)
Maltese: Trabi (età ta' < 6 xhur)
English: Trisodium citrate dihydrate (see leaflet for further information) Citric acid monohydrate
Maltese: Trisodium citrate dihydrate (ara l-fuljett ta' tagħrif għal aktar informazzjoni) Citric acid monohydrate
English: The majority of patients (58%) had LDLcholesterol > 190 mg/dl at study entry, and 24% of patients with LDL-cholesterol > 190 mg/dl were on lipid lowering medicinal products.
Maltese: Il-maġġoranza tal-pazjenti (58%) kellhom LDL kolesterol ta' > 190 mg/dl meta daħlu fl-istudju, u 24% tal-pazjenti b'LDL kolesterol ta' > 190 mg/dl kienu qed jieħdu prodotti mediċinali li jbaxxu l-lipidi.
English: Three patients of 106 (3%) patients treated with KANUMA, including 1 of 14 (7%) infants and 2 of 92 (2%) children and adults, in clinical studies experienced signs and symptoms consistent with anaphylaxis.
Maltese: Tliet pazjenti minn 106 (3%) pazjenti kkurati b'KANUMA, inkluż 1 minn 14-il (7%) tarbija u 2 minn 92 (2%) tfal u adulti, fi studji kliniċi kellhom sinjali u sintomi konsistenti ma' anafilassi.
English: In LAL-CL02, 5 of 35 evaluable children and adults (14%) who were administered KANUMA during the 20-week double-blind period of the study developed ADA.
Maltese: F'LAL-CL02, 5 minn 35 tfal u adulti (14%) li setgħu jiġu evalwati li ngħataw KANUMA matul ilperjodu double-blind ta' 20 ġimgħa tal-istudju, żviluppaw ADA.
English: AUCss = Area under the plasma concentration time curve at steady-state Cmax = Maximum concentration
Maltese: AUCss = Erja taħt il-kurva tal-konċentrazzjoni fil-plażma kontra l-ħin fi stat fiss Cmax = Konċentrazzjoni massima
English: The age range at randomisation was 4-58 years old (71% were < 18 years old).
Maltese: Ilfirxa ta' età meta l-parteċipanti ntgħażlu b'mod każwali kienet ta' 4-58 sena (71% kellhom età ta' < 18-il sena).