FrancophonIA/ELRC3.0 huggingface dataset:
English: • Administration
Maltese: • Rikostituzzjoni
English: Deficiency of this enzyme leads to glycogen accumulation in various tissues, particularly cardiac, respiratory and skeletal muscle, leading to the development of hypertrophic cardiomyopathy and progressive muscle weakness, including impairment of respiratory function.
Maltese: partikularment fil-muskoli kardijaċi, respiratorji u skeletriċi, li twassal għall-iżvilupp ta' kardjomijopatija ipertrofika u dgħjufija progressiva fil-muskoli, li tinkludi indeboliment tal-funzjoni respiratorja.
English: • Nausea
Maltese: • Sfura
English: *One patient who did not have data post baseline was excluded from the analyses.
Maltese: *Pazjent li ma kellux dejta ta' wara l-linja bażi ġie eskluż mill-analiżi.
English: 4 Additional adverse reactions from post-marketing, expanded access programs and non-controlled clinical trials.
Maltese: Reazzjonijiet avversi addizzjonali minn wara t-tqegħid fis-suq, programmi ta' aċċess imkabbar u provi kliniċi mhux ikkontrollati.
English: Mean plasma clearance (CL) was 21.4 ml/h/kg and mean volume of distribution at steady state (Vss) was 66.2 ml/kg for both dose groups with small between-subject variability of 15% and 11%, respectively.
Maltese: Il-medja tat-tneħħija tal-plażma (CL) kienet ta' 21.4 ml/siegħa/kg u l-medja tad distribuzzjoni tal-volum fl-istat fiss (Vss) kienet ta' 66.2 ml/kg għaż-żewġ gruppi li kienu qed jieħdu d-doża, b'varjabilità żgħira bejn il-pazjenti ta' 15% u 11%, rispettivament.
English: The late-onset form of Pompe disease manifests during infancy, childhood, adolescence or even adulthood and is much less rapidly progressive than the infantile-onset form.
Maltese: Il-forma tal-marda ta' Pompe li tibda aktar tard fil-ħajja tkun osservata matul l-infanzja, it-tfulija, l adolexxenza jew meta persuna ssir adulta, u hi ħafna inqas progressiva b'mod mgħaġġel mill-forma tal-marda li tibda fl-infanzja.
English: Fertility
Maltese: Dilwizzjoni
English: In clinical studies doses up to 40 mg/kg body weight were used.
Maltese: Fi studji kliniċi, intużaw dożi sa 40 mg/kg ta' piż tal-ġisem.
English: Myozyme is given through a drip into a vein (by intravenous infusion).
Maltese: Myozyme jingħata minn ġo dripp ġo vina (permezz ta' infużjoni ġol-vini).
English: 25 vials powder for concentrate for solution for infusion.
Maltese: 25 kunjett trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Because it is a recombinant human protein, alglucosidase alfa is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Maltese: Minħabba li hu proteina umana rikombinanti, alglucosidase alfa mhux mistenni li jikkawża interazzjonijiet bejn mediċina u oħra medjati minn ċitokrom P450.
English: Week 12
Maltese: Ġimgħa 12
English: In a pivotal trial including 18 patients, the pharmacokinetics of alglucosidase alfa were evaluated in 15 patients with infantile-onset Pompe disease (all less than 6 months of age at treatment-onset) who received doses of 20 mg/kg or 40 mg/kg alglucosidase alfa as an approximate 4 to 6.5-hour infusion, respectively.
Maltese: Pazjenti li fihom il-marda ta' Pompe bdiet fl-infanzja Fi prova importanti ħafna li kienet tinkludi 18-il pazjent, il-farmakokinetika ta' alglucosidase alfa kienet evalwata fi 15-il pazjent li fihom il-marda ta' Pompe bdiet fl-infanzja (li kollha kellhom inqas minn 6 xhur fil-bidu tal-kura) li rċivew dożi ta' 20 mg/kg jew 40 mg/kg ta' alglucosidase alfa bħala infużjoni ta' madwar 4 sa 6.5 sigħat, rispettivament.
English: Adverse reactions reported in at least 2 patients are listed in Table 1.
Maltese: (ADRs) rrappurtati f'mill-inqas 2 pazjenti huma elenkati f'Tabella 1.
English: Marketing Authorisation Holder Genzyme Europe B.V.
Maltese: Genzyme Europe B.V.
English: A retrospective chart review at Duke Center identified 21 CRIM-negative IOPD patients of which 19 patients were ERT naïve at the time of ITI initiation.
Maltese: Analiżi retrospettiva tal-profil kliniku fiċ-Ċentru Duke identifikat 21 pazjent IOPD negattivi għal CRIM li minnhom 19-il pazjent qatt ma kienu rċevew ERT fiż-żmien li nbeda t-trattament b'ITI.
English: Nausea3
Maltese: Għeja kbira3
English: It was demonstrated that the use of a 0.2 micron in-line filter removes visible particles and does not result in an apparent loss of protein or activity.
Maltese: Kien muri li l-użu ta' filtru in-line ta' 0.2 micron ineħħi partikuli viżibbli u ma jirriżultax f'telf apparenti ta' proteina jew attività.
English: AUC∞ and Cmax were similar at week 0, 12 and 52 visits indicating alglucosidase alfa pharmacokinetics were not timedependent (Table 5).
Maltese: AUC∞ u Cmax kienu simili fil-viżti f'ġimgħa 0, 12 u 52 li jindika li l-farmakokinetika ta'
English: This enzyme helps the body control levels of glycogen (a type of carbohydrate).
Maltese: Din l-enzima tgħin lill-ġisem jikkontrolla l-livelli ta' glycogen (tip ta' carbohydrate).
English: IgG antibody titres should be regularly monitored.
Maltese: It-titres ta' l-antikorpi għal IgG għandhom ikunu mmonitorjati regolarment.
English: The t½ of approximately 2-3 hours was also similar in this group of patients.
Maltese: It-t½ ta' madwar 2-3 sigħat kienet simili wkoll f'dan il-grupp ta' pazjenti.
English: Use of ITI and alglucosidase alfa has been evaluated in 1 clinical trial and a retrospective chart review of patients naïve to ERT at the initiation of treatment and 1 clinical trial of patients already receiving alglucosidase alfa at time of initiating ITI.
Maltese: L-użu ta' ITI u alglucosidase alfa ġew evalwati f'prova klinika 1 u b'analiżi retrospettiva tal-profil kliniku ta' pazjenti li qatt ma rċevew ERT fil-bidu tat-trattament u prova klinika 1 ta' pazjenti li diġà kienu qed jirċievu alglucosidase alfa fiż-żmien li bdew jieħdu ITI.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The % predicted FVC changed by a median of 0.0 for Myozyme-treated patients and decreased by a median of 3% for placebo-treated patients, indicating a statistically significant treatment effect (p=0.0026).
Maltese: Il-% imbassar tal-FVC inbidel b'medjan ta' 0.0 għal pazjenti kkurati b'Myozyme u naqas b'medjan ta' 3% għal pazjenti kkurati bil-plaċebo, u dan jindika effett tal kura li hu statistikament sinifikanti (p=0.0026).
English: Myozyme contains an artificial enzyme called alglucosidase alfa - this can replace the natural enzyme which is lacking in Pompe disease.
Maltese: Myozyme fih enzima artifiċjali msejħa alglucosidase alfa - din tista' tissostitwixxi l-enzima naturali li tkun nieqsa fil-marda ta' Pompe.
English: Each vial contains 50 mg of alglucosidase alfa.
Maltese: Kull kunjett fih 50 mg ta' alglucosidase alfa
English: Infantile-onset Pompe disease; clinical trial in patients aged 6 months to 3.5 years A second open-label clinical trial also assessed the safety and efficacy of Myozyme in 21 patients with predominantly a non-typical form of infantile-onset Pompe disease who ranged in age from 6 months to 3.5 years at initiation of treatment.
Maltese: It-tieni studju kliniku tat-tip open-label evalwa wkoll is-sigurtà u effikaċja ta' Myozyme f'21 pazjent li fil-biċċa l-kbira tagħhom kellhom forma mhux tipika tal-marda ta' Pompe li bdiet fl-infanzja, li varjaw fl-età minn 6 xhur sa 3.5 snin fil-bidu tal-kura.
English: • Muscle spasms
Maltese: • Tħoss is-sħana
English: • Retching
Maltese: • Rimettar
English: Recurrent reactions consisting of flu-like illness or a combination of events such as fever, chills, myalgia, arthralgia, pain, or fatigue occurring post-infusion and lasting usually for a few days, have been observed in some patients treated with alglucosidase alfa.
Maltese: Reazzjonijiet rikorrenti li jikkonsistu minn mard simili għall-influwenza jew kombinazzjoni ta' avvenimenti bħal deni, tertir, mijalġja, artralġja, uġigħ jew għeja li jseħħu wara l-infużjoni u li normalment idumu xi ftit tal-jiem, ġew osservati f'xi pazjenti kkurati b'alglucosidase alfa.
English: After 52 weeks of treatment, all 18 patients treated with Myozyme were alive and 15 of these 18 patients were alive and free of invasive ventilatory support whereas 1 of 42 patients in the untreated historical cohort was alive at 18 months of age.
Maltese: Wara 52 ġimgħa ta' kura, it-18-il pazjent kollha kkurati b'Myozyme kienu ħajjin, u 15 minn dawn it-18-il pazjent kienu ħajjin u ħielsa minn sapport ta' ventilazzjoni invażiva, filwaqt li 1 minn 42 pazjent filkoorti storiku mhux ikkurat kien ħaj meta kellu 18-il xahar.
English: Nephrotic syndrome was observed in a few patients with Pompe disease treated with alglucosidase alfa and who had high IgG antibody titres (≥ 102,400) (see section 4.8).
Maltese: Is-sindrome nefrotiku ġie osservat fi ftit pazjenti bil-marda ta' Pompe ikkurati b'alglucosidase alfa u li kellhom titres għoljin ta' antikorpi għal IgG (≥ 102,400)
English: Survival in the treated patients was compared to survival in a similar historical cohort of untreated subjects using a Cox proportional hazards regression analysis (See Table 3).
Maltese: Is-sopravivenza fil-pazjenti kkurati tqabblet mas-sopravivenza f'koorti storiku simili ta' pazjenti mhux ikkurati bl-użu ta' l-analiżi tar-rigressjoni tal-perikli proporzjonali ta' Cox (Ara Tabella 3).
English: • One study in Italy enrolled 74 late-onset patients with up to 48 months follow up.
Maltese: •Fl-Italja sar studju wieħed b'follow-up sa 48 xahar fejn kienu rreġistrati 74 pazjenti bil-marda ta' Pompe li bdiet tard fil-ħajja tagħhom
English: Serious adverse reactions reported in 4 patients treated with Myozyme were: angioedema, chest discomfort, throat tightness, non-cardiac chest pain and supraventricular tachycardia.
Maltese: Reazzjonijiet avversi serji rrappurtati f'4 pazjenti kkurati b'Myozyme kienu: anġjoedema, skonfort fis-sider, dwejjaq filgerżuma, uġigħ mhux kardijaku fis-sider u takikardija supraventrikulari.
English: Patients with infantile-onset Pompe disease who demonstrated motor gains, had greater preservation of motor function and lower glycogen content in the quadriceps muscle at baseline.
Maltese: Pazjenti li fihom il-marda ta' Pompe bdiet fl-infanzja li urew titjib fil-moviment, kellhom preservazzjoni akbar tal-funzjoni tal-moviment u kontenut ta' glycogen aktar baxx fil-muskolu quadriceps fil-linja bażi.
English: Pyrexia common Irritability Chills
Maltese: Disturbi psikjatriċi komuni
English: Patients with Pompe disease are at increased risk of respiratory infections due to the progressive effects of the disease on the respiratory muscles.
Maltese: Il-pazjenti bil-marda ta' Pompe huma f'riskju ogħla ta' infezzjonijiet respiratorji minħabba effetti progressivi tal-marda fuq il-muskoli respiratorji.
English: Rash common Erythema Rash maculopapular Rash macular Rash papular Pruritus
Maltese: Raxx makulopapulari Raxx makulari
English: It is postulated that Myozyme will restore lysosomal GAA activity resulting in stabilisation or restoration of cardiac and skeletal muscle function (including respiratory muscles).
Maltese: Hu kkalkulat li Myozyme ser ireġġa' lura għan-normal l-attività lisosomali GAA li tirriżulta fl istabbilizzazzjoni jew fir-restituzzjoni tal-funzjoni kardijaka u tal-muskoli skeletriċi (li tinkludi lmuskoli respiratorji).
English: • Wheezing
Maltese: • Dilwizzjoni
English: Of the 21 patients, 16 survived through the end of this study, with a median time from ERT initiation to last assessment of 44.6 months (range: 5.7 to 105.47); 5 patients died due to respiratory failure and disease progression, all of whom were ERTnaïve at the start of ERT+ITI treatment.
Maltese: Mill21 pazjent, 16 baqgħu ħajjin sal-aħħar tal-istudju, bi żmien medjan mill-bidu ta' trattament b'ERT sal aħħar evalwazzjoni ta' 44.6 xhur (marġni: 5.7 sa 105.
English: Hypersensitivity/Anaphylactic reactions
Maltese: Linearità/nuqqas ta' linearità
English: Therefore, a 0.2 micron low protein binding in-line filter should be used for administration.
Maltese: Għalhekk, filtru in-line low protein binding ta' 0.2 micron għandu jintuża għallgħoti.
English: Mean ± s.d.
Maltese: Vistor hf.
English: Reference
Maltese: LISTA
English: • Sudden constriction of bronchi restricting air going in and out the lungs (bronchospasm)
Maltese: • Restrizzjoni għal għarrieda tal-bronki li jikkawżaw restrizzjoni fl-arja dieħla u ħierġa mill pulmun (bronkospażmu)
English: After the first year (58 up to 168 weeks) of treatment LVM further decreased in 9 out of 12 patients with available data.
Maltese: Wara l-ewwel sena (minn 58 sa 168 ġimgħa) ta' kura, lLVM naqas b'mod ulterjuri f'9 minn 12-il pazjent b'dejta disponibbli.
English: • Itchy skin
Maltese: • Tħarħir
English: Myozyme has to be reconstituted with water for injections, then diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and then administered by intravenous infusion.
Maltese: Injetta bil mod Myozyme rikostitwit direttament ġos-sodium chloride 9 mg/ml (0.9%) soluzzjoni għallinjezzjoni.
English: Additional efficacy data showed that of 16 patients who were free of invasive-ventilator support at baseline, 7 remained so after 104 weeks of treatment.
Maltese: Informazzjoni addizzjonali dwar l-effikaċja wriet li mis-16-il pazjent li kienu ħielsa minn sapport ta' ventilazzjoni invażiva fil-linja bażi, 7 baqgħu hekk wara 104 ġimgħat ta' kura.
English: How to store Myozyme
Maltese: X'fih Myozyme
English: Excipients:
Maltese: NN:
English: In 12 patients with available data the AUC∞ and Cmax were approximately equivalent to those observed for the 20 mg/kg dose group in the pivotal trial.
Maltese: Fi 12-il pazjent li għalihom kien hemm informazzjoni disponibbli, l-AUC∞ u s-Cmax kienu ta' bejn wieħed u ieħor ekwivalenti għal dawk osservati għallgrupp li ngħata doża ta' 20 mg/kg fil-prova importanti ħafna.
English: Chest discomfort Peripheral oedema Local swelling Fatigue3
Maltese: Skonfort fis-sider Edema periferali
English: Myozyme 50 mg powder for concentrate for solution for infusion Alglucosidase alfa
Maltese: Myozyme 50 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Patients should be monitored for signs and symptoms of systemic immune-mediated reactions involving skin and other organs while receiving alglucosidase alfa.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' reazzjonijiet sistemiċi immuni medjati li jinvolvu l-ġilda u organi oħra waqt li jkunu qed jirċievu alglucosidase alfa.
English: 10 vials powder for concentrate for solution for infusion.
Maltese: 10 kunjetti trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni jkun fiha 5 mg ta' alglucosidase alfa/ml u wara d-dilwizzjoni, il konċentrazzjoni tvarja minn 0.5 mg sa 4 mg/ml.
English: Respiratory distress Bronchospasm Wheezing Pharyngeal oedema Dyspnoea Tachypnoea Throat tightness Stridor
Maltese: Dan il-fuljett kien rivedut l-aħħar f' Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall
English: Marketing Authorisation Holder and Manufacturer
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: • Dizziness
Maltese: • Aġitazzjoni
English: Late-onset Pompe disease; pivotal clinical trial
Maltese: Pazjenti li fihom il-marda ta' Pompe bdiet tard fil-ħajja; prova klinika prinċipali
English: Median Week 78/Last Observation Mean ± s.d.
Maltese: Tibdil mil-Linja Bażi sa Ġimgħa 78/L-Aħħar
English: Pre-treatment Baseline
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: The study data demonstrated that prophylactic ITI prevents or reduces the occurrence of antibodies against alglucosidase alfa over time, which may maintain clinical benefit of ERT and improve survival in CRIM-negative IOPD patients.
Maltese: It-tagħrif mill-istudju juri li ITI mogħti bħala profilassi jippreveni jew inaqqas li maż-żmien ikun hemm antikorpi kontra alglucosidase alfa, li jista' jmantni l-benefiċċju kliniku ta' ERT u jtejjeb is-sopravivenza f'pazjenti IOPD negattivi għal CRIM.
English: Cough
Maltese: Wara
English: Patients who have experienced IARs (and in particular anaphylactic reactions) should be treated with caution when re-administering Myozyme (see sections 4.3 and 4.8).
Maltese: Pazjenti li kellhom IARs (u b'mod partikulari reazzjonijiet anafilattiċi) għandhom ikunu kkurati blattenzjoni meta jerġa' jingħata Myozyme (ara sezzjonijiet 4.3 u 4.8).
English: The reconstituted volume is 10.5 ml containing 5 mg enzyme/ml, and appears as a clear, colourless to pale yellow solution which may contain particles in the form of thin white strands or translucent fibres.
Maltese: Il-volum rikostitwit hu ta' 10.5 ml li fih 5 mg/ml, u jidher bħala soluzzjoni ċara li tkun minn bla kulur sa isfar ċar, u li jista' jkun fiha frak fis-sura ta' ħjut rqaq bojod jew fibri transluċidi.
English: Infantile-onset Pompe disease
Maltese: GĦAMLA FARMAĊEWTIKA
English: Patients with an acute illness (e.g. pneumonia, sepsis) at the time of Myozyme infusion appear to be at greater risk for IARs.
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3). Mhux magħruf ir-riskju potenzjali fuq in-nies.
English: There is no experience with overdose of alglucosidase alfa.
Maltese: (HSAT) kontra alglucosidase alfa.
English: Arthralgia
Maltese: Ċijanosi
English: Infantile-onset Pompe disease1
Maltese: Pazjenti li fihom ilmarda bdiet flinfanzja Marda ta' Pompe1
English: • Muscle pain
Maltese: Raxx papulari
English: Serious and life-threatening anaphylactic reactions, including anaphylactic shock, have been reported in infantile- and late-onset patients during Myozyme infusions (see section 4.8).
Maltese: Reazzjonijiet anafilattiċi serji u ta' periklu għall-ħajja, li jinkludu xokk anafilattiku, kienu rrappurtati f pazjenti li fihom il-marda bdiet fl-infanzja u dawk li fihom il-marda bdiet tard fil-ħajja waqt l infużjonijiet ta' Myozyme (ara sezzjoni 4.8).
English: Late-onset Pompe disease
Maltese: Spażmi tal-muskoli
English: Wilcoxon-Mann-Whitney Test p-value Forced Vital Capacity (Percent of predicted normal) Pre-treatment Baseline
Maltese: Kapaċità Vitali Sfurzata (Perċentwali tan-normal imbassar) Linja Bażi Qabel il-Kura
English: Some reactions were severe (see section 4.8).
Maltese: Xi reazzjonijiet kienu severi (ara sezzjoni 4.8).
English: Peripheral coldness Infusion site pain Infusion site reaction Infusion site swelling Infusion site induration
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Late-onset Pompe disease; other clinical trials and analyses Three independent, open-label, single arm, investigator-initiated studies with Myozyme were conducted:
Maltese: Pazjenti li fihom il-marda ta' Pompe bdiet tard fil-ħajja; provi kliniċi oħrajn u analiżi Saru tlett studji bil-Myozyme li huma ndipendenti, open-label, b'fergħa waħda u mibdija minn investigaturi
English: Myozyme 50 mg powder for concentrate for solution for infusion
Maltese: TAL-PRODOTT MEDIĊINALI Myozyme 50 mg, trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The recommended dose regimen of alglucosidase alfa is 20 mg/kg of body weight administered once every 2 weeks.
Maltese: Il-kors tad-dożaġġ rakkomandat ta' alglucosidase alfa hu ta' 20 mg/kg ta' piż tal-ġisem, mogħti darba kull ġimagħtejn.
English: Reconstitute each 50 mg vial of Myozyme with 10.3 ml water for injections using a syringe with a needle diameter not larger than 20 gauge.
Maltese: Irrikostitwixxi kull kunjett ta' 50 mg ta' Myozyme b'10.3 ml ta' ilma għall-injezzjonijiet billi tuża siringa b'labra ta' dijametru ta' mhux aktar minn 20 gauge.
English: It is recommended that the infusion begin at an initial rate of 1 mg/kg/h and be gradually increased by 2 mg/kg/h every 30 minutes if there are no signs of infusion associated reactions (IARs) until a maximum rate of 7 mg/kg/h is reached.
Maltese: Hu rakkomandat li l-infużjoni tinbeda b'rata inizjali ta' 1 mg/kg/siegħa u tiżdied gradwalment b'2 mg/kg/siegħa kull 30 minuta jekk ma jkun hemm l-ebda sinjali ta' reazzjonijiet assoċjati ma' l-infużjoni (IARs) sakemm tintlaħaq rata massima ta' 7 mg/kg/siegħa.
English: Some patients have experienced infusion related side effects in the form of flu-like symptoms, which lasted for a few days after completion of the infusion.
Maltese: Xi pazjenti kellhom effetti sekondarji relatati mal-infużjoni fil-forma ta' sintomi simili għal dawk tal-influwenza, li damu għal ftit jiem wara li ntemmet l-infużjoni.
English: After 52 weeks of treatment, 3 out of 8 patients with available data made gains in motor function over baseline as measured by raw scores and age-equivalent scores from baseline in the AIMS.
Maltese: Wara 52 ġimgħa ta' kura, 3 minn 8 pazjenti b'dejta disponibbli kellhom titjib fil-funzjoni tal moviment fuq il-linja bażi kif imkejjel mill-punteġġi mhux analizzati u punteġġi ekwivalenti għall-età mil-linja bażi fl-AIMS.
English: 1 vial powder for concentrate for solution for infusion.
Maltese: 1 kunjett trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Periorbital edema Livedo reticularis Lacrimation increased Rash
Maltese: Jekk tuża dawn il-mediċini biex trażżan lis-sistema immuni, dan jista'
English: Some patients have been successfully rechallenged and continued to receive alglucosidase alfa under close clinical supervision.
Maltese: Xi pazjenti reġgħu ngħataw u komplew jirċievu alglucosidase alfa b'suċċess, taħt superviżjoni klinika mill-qrib.
English: Diarrhoea Vomiting
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Throat tightness
Maltese: • Ġilda bi tbajja'
English: Heart rate increased
Maltese: Komparatur Storiku tar
English: Treatment Effect Hazard Ratio
Maltese: .8 Effetti mhux mixtieqa
English: Due to the bloodbrain barrier effect and the enzyme's size, uptake of alglucosidase alfa in the central nervous system is unlikely.
Maltese: alglucosidase alfa fis-sistema nervuża ċentrali mhuwiex mistenni.
English: No significant adverse findings on embryofoetal development were observed in a mouse and a rabbit embryofoetal study and no significant adverse findings were observed in a mouse fertility and early embryonic development study.
Maltese: u l-ebda sejbiet avversi sinifikanti ma kienu osservati fi studju dwar il-fertilità u liżvilupp bikri embrijufetali fil-ġrieden.
English: Infantile-onset Pompe disease; clinical trial in patients aged 6 months or less The safety and efficacy of Myozyme was assessed in a pivotal, randomised, open-label, historicallycontrolled clinical trial of 18 non-ventilated infantile-onset patients aged 6 months or less at the onset of treatment.
Maltese: Is-sigurtà u l-effikaċja ta' Myozyme kienet evalwata fi prova klinika importanti ħafna, randomised,
English: Infantile- and Lateonset Pompe disease
Maltese: • Uġigħ fil-muskoli • Spażmi tal-muskoli
English: Also remove an equal volume of sodium chloride 9 mg/ml (0.9%) solution for injection, that will be replaced with reconstituted Myozyme.
Maltese: Neħħi wkoll l-istess volum ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, li ser ikun sostitwit b'Myozyme rikostitwit.
English: Flushing common Hypertension Pallor
Maltese: GĦAMLA KWALITATTIVA
English: Based on these results the 20 mg/kg qow dose is recommended.
Maltese: Ibbażat fuq dawn ir-riżultati, id-doża ta' 20 mg/kg kull ġimagħtejn hi rakkomandata.
English: Hypertension Hypotension Vasoconstriction Pallor
Maltese: Żieda fit-temperatura tal-ġisem
English: • Cough
Maltese: • Nawsja