FrancophonIA/ELRC3.0 huggingface dataset:
English: Nephrotic syndrome Proteinuria
Maltese: Sindrome nefrotiku Proteinurija
English: Wilcoxon-Mann-Whitney Test p-value
Maltese: Test ta' Wilcoxon-MannWhitney valur p
English: Kaplan-Meier survival rates at 12, 24 and 36 months of age were 26%, 9% and 7%, respectively.
Maltese: Ir-rati ta' sopravivenza ta' Kaplan-Meier fi 12, 24 u 36 xahar ta' età kienu ta' 26%, 9% u 7%, rispettivament.
English: Sanofi A/S Tlf: +45 45 16 70 00
Maltese: Danmark Sanofi A/S Tlf: +45 45 16 70 00
English: Pack sizes of 1, 10 or 25 vials.
Maltese: Kull pakkett fih 1, 10 jew 25 kunjett.
English: Myozyme contains sodium
Maltese: Myozyme fih sodium
English: Class, presented by frequency categories: 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
Maltese: frekwenza: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Cmax (µg/ml) AUC∞ (µg•h/ml) CL (ml/h/kg) Vss (ml/kg) Effective half-life (h)
Maltese: AUC∞ (µg•siegħa/ml) CL (ml/siegħa/kg)
English: Additional adverse reactions4
Maltese: Reazzjonijiet avversi addizzjonali4
English: IOPD Immune Tolerance Induction
Maltese: Stimulazzjoni għat-tolleranza immunitarja IOPD
English: Immunomodulation
Maltese: Immunoġeniċità
English: Gastrointestinal disorders very common
Maltese: Disturbi gastrointestinali komuni ħafna
English: Confidence Interval p-value
Maltese: Intervall talKunfidenza valur p
English: Mean ± s.d Median
Maltese: Medja ± s.d Medjan
English: Other names for Pompe disease include glycogen storage disease type II (GSDII), acid maltase deficiency (AMD) and glycogenosis type II.
Maltese: glycogen ta' tip II (GSD-II), defiċjenza ta' acid maltase (AMD) u glikoġenesi ta' tip II.
English: 50 mg of powder in a vial (Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic).
Maltese: 50 mg ta' trab f'kunjett (ħġieġ ta' Tip 1) b'tapp (siliconised butyl) u siġill (ta' l-aluminju) b'għatu flip off (tal-plastik).
English: *Human acid α-glucosidase is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology.
Maltese: *Acid α-glucosidase uman u hu magħmul fiċ-ċelluli tal-ovarji tal-ħamster Ċiniż (CHO) minn teknoloġija DNA rikombinanti.
English: Of the 3 patients with significant pulmonary involvement at screening/baseline (percentage predicted forced vital capacity in the sitting position ranging from 5867%), two demonstrated clinically meaningful improvements in FVC (+11.5% and +16.0%) in the sitting position by Week 26.
Maltese: 3 pazjenti b'involviment pulmonari sinifikanti fl-iscreening/linja bażi (il-perċentwali bassret il-ħila vitali sfurzata fil-pożizzjoni ta' bilqiegħda li varjat minn 58 - 67%), tnejn urew titjib klinikament sinifikanti fl-FVC (+11.5% u +16.0%) fil-pożizzjoni ta' bilqiegħda minn ġimgħa 26.
English: Nervous system disorders common Tremor
Maltese: Disturbi fis-sistema nervuża komuni
English: The co-primary efficacy outcome assessments were distance walked (meters) in 6 minutes (6-Minute Walk Test, 6MWT) and FVC (Forced Vital Capacity) % predicted in the sitting position.
Maltese: L-evalwazzjonijiet tar-riżultat tal-effikaċja ko-primarja kienu d-distanza li l-pazjenti mxew (metri) f'6 minuti (Test tal-Mixja ta' 6 minuti, 6MWT) u l-% imbassar tal-FVC (Kapaċità Vitali Sfurzata) filpożizzjoni ta' bilqiegħda.
English: Tachypnoea Cough common
Maltese: Sogħla komuni
English: At 104 weeks of treatment LVM assessments were available for 10 patients, of which 9 decreased to within normal limits.
Maltese: Wara 104 ġimgħat ta' kura, evalwazzjonijiet tal-LVM kienu disponibbli għal 10 pazjenti, li minnhom 9 naqsu sal-limiti normali.
English: Pompe disease is a rare, progressive and fatal metabolic myopathy with an estimated global incidence of 1 in 40,000 births.
Maltese: Il-marda ta' Pompe hi mijopatija metabolika rari, progressiva u fatali b'inċidenza globali stmata ta' 1 minn kull 40,000 twelid.
English: Immunogenicity
Maltese: Immunomodulazzjoni
English: Use aseptic technique
Maltese: Uża t-teknika asettika
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini
English: 2 Reactions reported in 60 late-onset patients in a placebo-controlled clinical trial.
Maltese: 2 Reazzjonijiet irrappurtati f'60 pazjenti li fihom il-marda bdiet tard fil-ħajja fi prova klinika kkontrollata bil-plaċebo.
English: Pompe disease belongs to the lysosomal storage disorders as it is caused by a deficiency of a naturally-occurring lysosomal hydrolase, acid αglucosidase (GAA) that degrades lysosomal glycogen to glucose.
Maltese: Il-marda ta' Pompe tappartieni għad-disturbi tal-ħażna lisosomali għax hi kkawżata minn defiċjenza ta' hydrolase lisosomali li sseħħ b'mod naturali, acid α-glucosidase (GAA) li jiddegrada glycogen lisosomali għal glucose.
English: At 104 weeks of treatment LVM assessments were available for 8 patients, of which 5 decreased to within normal limits.
Maltese: Wara 104 ġimgħat ta' kura, evalwazzjonijiet talLVM kienu disponibbli għal 8 pazjenti, li minnhom 5 naqsu sal-limiti normali.
English: Cardiac arrest Bradycardia Tachycardia Cyanosis
Maltese: Waqfien tal-qalb Bradikardija Takikardija
English: • Irritability
Maltese: • Sturdament • Irritabilità
English: IARs are described in section 4.8.
Maltese: L-IARs huma deskritti f'sezzjoni 4.8.
English: The distance walked in 6 minutes increased by a median of 15.0 meters for Myozyme-treated patients and decreased by a median of 7.5 meters for placebo-treated patients, indicating a statistically significant Myozyme treatment effect compared to placebo (p=0.0283).
Maltese: 0 metri għal pazjenti kkurati b'Myozyme u naqset b'medjan ta' 7.5 metri għal pazjenti kkurati bil-plaċebo, u dan jindika effett tal-kura b'Myozyme li hu statistikament sinifikanti meta mqabbel mal-plaċebo (p=0.0283).
English: Patients were randomized in a 2:1 ratio and received 20 mg/kg Myozyme (n=60) or placebo (n=30) once every two weeks for 78 weeks (18 months).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 2:1 u rċivew 20 mg/kg ta' Myozyme (n=60) jew plaċebo (n=30) darba kull ġimagħtejn għal 78 ġimgħa (18-il xahar).
English: Other medicines and Myozyme
Maltese: Mediċini oħra u Myozyme
English: An open-label clinical trial assessed the safety and efficacy of Myozyme in 5 patients with late-onset Pompe disease who ranged in age from 5 to 15 years at initiation of treatment (AGLU02804).
Maltese: Studju kliniku tat-tip open-label evalwa s-sigurtà u effikaċja ta' Myozyme f'5 pazjenti li fihom ilmarda ta' Pompe bdiet tard fil-ħajja, li varjaw fl-età minn 5 sa 15-il sena fil-bidu tal-kura (AGLU02804).
English: Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Maltese: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: The safety and efficacy of Myozyme was assessed in a randomized, double-blind, placebo-controlled study in 90 patients with late-onset Pompe disease who ranged in age from 10 to 70 years at initiation of treatment and were all naive to enzyme replacement therapy.
Maltese: Is-sigurtà u l-effikaċja ta' Myozyme kienu evalwati fi studju randomized, double-blind, ikkontrollat bil-plaċebo f'90 pazjent li fihom il-marda ta' Pompe bdiet tard fil-ħajja, li varjaw fl-età minn 10 sa 70il sena fil-bidu tal-kura u li kollha kienu naive għat-terapija tas-sostituzzjoni tal-enzimi.
English: Placebo (N = 30)
Maltese: (N = 30)
English: The untreated historical cohort was matched to the pivotal study population and was derived from a retrospective natural history study (n=42) in patients with infantile-onset Pompe disease.
Maltese: Il-koorti storiku mhux ikkurat kien imqabbel ma' l-istudju importanti ħafna u kien miksub minn studju retrospettiv ta' l-istorja naturali (n=42)
English: Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency).
Maltese: Myozyme hu indikat għat-terapija fit-tul ta' sostituzzjoni tal-enzimi (ERT) f'pazjenti b'dijanjosi kkonfermata tal-marda ta' Pompe (defiċjenza ta' acid α-glucosidase).
English: Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1, when rechallenge was unsuccessful (see sections 4.4 and 4.8).
Maltese: Sensittività eċċessiva (reazzjoni anafilattika) ta' periklu għall-ħajja għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1, meta r-rechallenge ma rnexxiex (ara sezzjonijiet 4.4 u 4.8).
English: In two additional open-label clinical trials with Myozyme with a follow-up of 24 months, ten patients with severe late-onset Pompe disease (moderate to severe motor impairment and assisted ventilation) showed a variable response on measures of motor and respiratory functions, mostly in the form of a modest improvement (AGLU03105, AGLU04107).
Maltese: F'żewġ provi kliniċi open-label b'Myozyme, għaxar pazjenti b'marda severa ta' Pompe li bdiet tard fil-ħajja (indeboliment motorju moderat għal sever u ventilazzjoni assistita) urew rispons varjabbli fil miżuri ta' funzjoni motorja u ta' funzjoni respiratorja, l-aktar bħala titjib modest (AGLU03105, AGLU04107)
English: The probability of a poor outcome and of developing high and sustained IgG antibody titres appears higher among CRIM-negative patients (Cross Reactive Immunologic Material- negative patients in whom no endogenous GAA protein was detected by Western blot analysis) than among CRIM-positive patients in whom endogenous GAA protein was detected by Western blot analysis and/or predicted based on genotype.
Maltese: Il-probabbiltà ta' riżultat batut u li wieħed jiżviluppa titres għoljin u sostnuti ta' antikorpi għal IgG tidher ogħla fost pazjenti li huma negattivi għal CRIM (Materjal Immunoloġiku Cross Reactive-pazjenti negattivi li fihom ma kienet osservata l-ebda proteina GAA endoġena mill-analiżi Western blot) milli fost pazjenti li kienu pożittivi għas-CRIM li fihom kienet osservata l-proteina GAA endoġena mill-analiżi Western blot u/jew mistennija skont il-ġenotip.
English: After the first and sixth infusion of Myozyme, mean maximum plasma concentrations (Cmax) ranged from 178.2 to 263.7 µg/ml for the 20 mg/kg and 40 mg/kg dose groups respectively.
Maltese: (Cmax) varjat minn 178.2 sa 263.7 µg/ml għall-gruppi li kienu qed jieħdu doża ta' 20 mg/kg u 40 mg/kg rispettivament.
English: People with Pompe disease have low levels of an enzyme called alpha-glucosidase.
Maltese: Nies bil-marda ta' Pompe għandhom livelli baxxi ta' enzima msejħa alpha-glucosidase.
English: Late-onset Pompe disease2
Maltese: Marda ta' Pompe2
English: Subjects ranged in age from 6 months to 3.5 years at initiation of treatment.
Maltese: Il-pazjenti varjaw minn età ta' 6 xhur sa 3.5 snin fil-bidu tal-kura.
English: In a retrospective natural history study in patients with infantile-onset Pompe disease (n=168), the median age at onset of symptoms was 2.0 months and the median age of death was 9.0 months.
Maltese: Fi studju retrospettiv dwar l-istorja naturali f'pazjenti li fihom il-marda ta' Pompe bdiet fl-infanzja (n=168), il-medjan ta' l-età meta bdew is-sintomi kien ta' xahrejn, u l-medjan ta' l-età tal-mewt kien ta' 9.0 xhur.
English: Week 0
Maltese: Ġimgħa 0
English: Myozyme is indicated in adults and paediatric patients of all ages.
Maltese: Myozyme hu indikat għall-użu f'persuni adulti u pazjenti pedjatriċi ta' kull età.
English: Table 1: Adverse reactions (reported in at least 2 patients) and adverse reactions reported in postmarketing setting, expanded access programs and non-controlled clinical trials, per System Organ
Maltese: Tabella 1: Reazzjonijiet avversi tal-mediċina (irrappurtati f'mill-inqas 2 pazjenti) u reazzjonijiet avversi rrappurtati fi sfond ta' wara t-tqegħid fis-suq, programmi ta' aċċess imkabbar u provi kliniċi mhux ikkontrollati, skont il-Klassi tal-Organi tas-Sistema, ippreżentata permezz tal-kategoriji ta'
English: Urticaria
Maltese: Pożoloġija
English: Such a reaction comprises different symptoms like low blood pressure, chest discomfort, throat tightness, face, lips or tongue swelling (angioedema), hives (urticaria), dizziness, rash, itchy skin, nausea, vomiting, cough and bronchospasm (see section 4 for an overview of all infusion-associated reactions).
Maltese: Reazzjoni bħal din tinkludi sintomi differenti bħal pressjoni tad-demm baxxa, skumdità fis-sider, sensazzjoni ta' għafis fil griżmejn, nefħa fil-wiċċ, xufftejn jew ilsien (anġjoedema), ħakk (urtikarja), sturdament, raxx, ħakk filġilda, nawsja, rimettar, sogħla u bronkospażmi (ara sezzjoni 4 għal deskrizzjoni fil-qosor tarreazzjonijiet kollha assoċjati mal-infużjoni).
English: The pharmacokinetics of alglucosidase alfa were studied in a population analysis of 32 late-onset Pompe disease patients from the randomized, double-blind, placebo-controlled study ranging in age from 21 to 70 years who received Myozyme 20 mg/kg once every two weeks.
Maltese: Il-farmakokinetika ta' alglucosidase alfa kienet studjata f'analiżi ta' popolazzjoni ta' 32 pazjent li fihom il-marda ta' Pompe bdiet tard fil-ħajja, minn studju randomized, double-blind, u kkontrollat bil plaċebo, li l-età tagħhom kienet tvarja minn 21 sa 70 sena li rċivew Myozyme 20 mg/kg darba kull ġimagħtejn.
English: • Nephrotic Syndrome: swelling of lower limbs, generalized swelling and protein loss in urine
Maltese: • Telf ta' proteina fl-awrina • Sindrome Nefrotiku: nefħa fir-riġlejn, nefħa ġeneralizzata u telf ta' proteina fl-awrina
English: • Cold extremities (e.g. hands, feet)
Maltese: • Kesħa fl-estremitajiet (eż. idejn, saqajn)
English: The pulmonary benefits observed in patients included a clinically meaningful improvement in FVC of 35% in one patient, and significant reductions in the number of hours of ventilator support needed in 2 patients.
Maltese: Il-benefiċċji pulmonari osservati fil-pazjenti inkludew titjib klinikament sinifikanti fl-FVC ta' 35% f'pazjent wieħed, u tnaqqis sinifikanti finnumru ta' sigħat ta' sapport tal-ventilatur meħtieġ f'2 pazjenti.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Genzyme Europe B.V. Paasheuvelweg 25
Maltese: Genzyme Europe B.V. Paasheuvelweg 25 1105 BP Amsterdam L-Olanda
English: There was no evidence that IgG antibodies to alglucosidase alfa affected pharmacokinetics.
Maltese: Ma kien hemm l-ebda evidenza li antikorpi għal IgG għal alglucosidase alfa affettwaw ilfarmakokinetika.
English: Table 4: Change from baseline: efficacy outcomes in the placebo-controlled study
Maltese: Tabella 4: Tibdil mil-linja bażi: riżultati tal-effikaċja fi studju kkontrollat bil-plaċebo
English: After 52 weeks of treatment 14 of 18 patients (77.8%) had maintained or improved weight-for-age percentiles (above the 3rd percentile), 14 of 15 patients (93.3%) were above the 3rd percentile for length and 12 of 15 patients (80.0%) were above the 3rd percentile for head circumference.
Maltese: Wara 52 ġimgħa ta' kura, 14 minn 18-il pazjent (77.8%) żammew jew tejbu l-percentiles piż-età (‘il fuq mit-3et percentile), 14 minn 15-il pazjent (93.3%) kienu ‘l fuq mit-3et percentile għat-tul u 12 minn 15-il pazjent (80.
English: 1 Reactions reported in 39 infantile-onset patients in 2 clinical trials.
Maltese: 1 Reazzjonijiet irrappurtati f'39 pazjent li fihom il-marda bdiet fl-infanzja f'2 provi kliniċi.
English: There are no clinical data on the effects of alglucosidase alfa on fertility.
Maltese: Fertilità M'hemm l-ebda dejta klinika dwar l-effetti ta' alglucosidase alfa fuq il-fertilità.
English: Immunogenicity data from clinical trials and published literature in CRIM-negative infantile-onset patients (IOPD) suggests that the administration of immune tolerance induction (ITI) regimen given to alglucosidase alfa naive patients (prophylactic ITI) may be effective in preventing or reducing the development of High Sustained Antibody Titer (HSAT) against alglucosidase alfa.
Maltese: Tagħrif dwar l-immunoġeniċità minn provi kliniċi u mill-letteratura ppublikata f'pazjenti negattivi għal CRIM u li kellhom il-marda minn meta kienu trabi-CRIM-negative infantile-onset patients (IOPD) jissuġġerixxi li l-għoti ta' skeda ta' stimulazzjoni għat-tolleranza immunitarja immune tolerance induction (ITI) mogħtija lil pazjenti li qatt ma rċevew alglucosidase alfa (ITI bħala profilassi) tista' tkun effettiva biex tippreveni jew tnaqqas l-iżvilupp ta' High Sustained Antibody Titer
English: -The active substance is alglucosidase alfa.
Maltese: - Is-sustanza attiva hi alglucosidase alfa 50 mg.
English: In a placebo-controlled study lasting 78 weeks, 90 patients with late-onset Pompe disease, aged 10 to 70 years, were treated with Myozyme or placebo randomized in a 2:1 ratio (see section 5.1).
Maltese: Pazjenti li fihom il-marda ta' Pompe bdiet tard fil-ħajja Fi studju kkontrollati bil-plaċebo li dam 78 ġimgħa, 90 pazjent li fihom il-marda ta' Pompe bdiet tard fil-ħajja, li kellhom minn 10 sa 70 sena, kienu kkurati b'Myozyme jew bil-plaċebo randomized fi proporzjon ta' 2:1 (ara sezzjoni 5.1).
English: Slowly inject the reconstituted Myozyme directly into the sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Injetta bil-mod Myozyme rikostitwit direttament ġos-sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: One vial contains 50 mg of alglucosidase alfa.
Maltese: Kunjett wieħed fih 50 mg ta' alglucosidase alfa.
English: The mean area under the plasma concentration-time curve (AUC∞) ranged from 977.5 to 1,872.5 µg•h/ml for the 20 mg/kg and 40 mg/kg dose groups.
Maltese: Il-medja taż-żona taħt il-konċentrazzjoni tal-plażma-kurva tal-ħin (AUC∞) varjat minn 977.5 sa 1,872.5 µg•siegħa/ml għall-gruppi li kienu qed jieħdu doża ta' 20 mg/kg u
English: Patients presented with a constellation of signs and symptoms, primarily respiratory, cardiovascular, edematous and/or cutaneous in nature (see section 4.4).
Maltese: Il-pazjenti kellhom varjetà kbira ta' sinjali u sintomi, li primarjament kienu respiratorji, kardjovaskulari, edematużi u/jew tal-ġilda fin natura tagħhom (ara sezzjoni 4.4).
English: Parameter
Maltese: terapija Parametru
English: Ten patients with advanced late-onset Pompe disease (i.e. wheelchair-bound for 10/10 and ventilatordependent for 9/10) aged 9-54 years were treated in expanded access programs with alglucosidase alfa 20-40 mg/kg once every two weeks for various periods of time between 6 months and 2.5 years.
Maltese: Għaxar pazjenti li fihom il-marda ta' Pompe bdiet tard fil-ħajja, bil-marda fi stat avvanzat (i.e. li kienu f'siġġu bir-roti għal 10/10 u jiddependu fuq ventilatur għal 9/10), li kellhom minn 9 sa 54 sena, kienu kkurati fi programmi b'aċċess imkabbar b'alglucosidase alfa 20-40 mg/kg darba kull ġimagħtejn għal diversi perjodi ta' żmien ta' bejn 6 xhur u 2.5 snin.
English: Tabulated list of adverse reactions
Maltese: Lista f'tabella ta' rezzjonijiet avversi
English: Table 5: Alglucosidase alfa pharmacokinetics after a single dose and after 12 and 52 weeks of therapy
Maltese: Il-farmakokinetika ta' alglucosidase alfa wara doża waħda u wara 12 u 52 ġimgħa ta'
English: The pharmacokinetics of alglucosidase alfa were also evaluated in a separate trial in 21 patients with infantile-onset Pompe disease (all aged between 6 months and 3.5 years at treatment-onset) who received doses of 20 mg/kg of alglucosidase alfa.
Maltese: Il-farmakokinetika ta' alglucosidase alfa kienet evalwata wkoll fi prova separata f'21 pazjent li fihom il-marda ta' Pompe bdiet fl-infanzja (kollha bejn l-età ta' 6 xhur u 3.5 snin fil-bidu tal-kura) li rċivew dożi ta' 20 mg/kg ta' alglucosidase alfa.
English: After 52 weeks of treatment, 16 of 21 patients (76.2%) treated with Myozyme were alive.
Maltese: Wara 52 ġimgħa ta' kura, 16 minn 21 pazjent (76.2%) kkurati b'Myozyme kienu ħajjin.
English: Serious infusion reactions including urticaria, rales, tachycardia, decreased oxygen saturation, bronchospasm, tachypnea, periorbital edema and hypertension have been reported.
Maltese: Reazzjonijiet serji għall-infużjoni kienu jinkludu urtikarja, ħsejjes tal-pulmun, takikardija, tnaqqis fissaturazzjoni tal-ossiġnu, bronkospażmu, takipnea, edema periorbitali, u pressjoni għolja kienu rrappurtati.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Maltese: Prodotti oħrajn għall-passaġġ ta' l-ikel u tal-metaboliżmu, enzimi.
English: Evaluation of motor function gave disparate results.
Maltese: L-evalwazzjoni tal-funzjoni tal-moviment tat riżultati differenti.
English: Musculoskeletal and connective tissue disorders common
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi komuni
English: A limited number of the IgG positive patients evaluated tested positive for inhibitory effects on in vitro testing.
Maltese: Instab li numru limitat ta' pazjenti li kienu evalwati kienu pożittivi għal IgG, instab li kienu pożittivi għal effetti inibitorji meta sar ittestjar in vitro.
English: Myozyme is a powder for concentrate for solution for infusion in a vial (50 mg/vial).
Maltese: Myozyme hu trab għal konċentrat għal soluzzjoni għall-infużjoni f'kunjett (50 mg/kunjett).
English: Severe cutaneous reactions, possibly immune mediated, have been reported with alglucosidase alfa, including ulcerative and necrotizing skin lesions (see section 4.8).
Maltese: Reazzjonijiet immuni medjati Reazzjonijiet severi tal-ġilda, possibbilment medjati mill-immunità, kienu rrappurtati b'alglucosidase alfa, li jinkludu leżjonijiet nekrotizzanti u ulċerattivi tal-ġilda (ara sezzjoni 4.8).
English: The recommended final concentration of alglucosidase in the infusion bags ranges from 0.5 mg/ml to 4 mg/ml.
Maltese: Il konċentrazzjoni finali rakkomandata ta' alglucosidase fil-boroż ta' l-infużjoni tvarja minn 0.5 mg/ml sa 4 mg/ml.
English: The clinical presentation of Pompe disease can be described as a spectrum of disease which ranges from a rapidly-progressing infantile-onset form (onset of symptoms of Pompe disease typically within the first year of life and a very short expected life-span) to a less rapidly-progressing late-onset form.
Maltese: Il-preżentazzjoni klinika tal-marda ta' Pompe tista' tkun deskritta bħala l-medda tal-marda li tvarja mill-forma tal-marda li tibda fl-infanzja li jkollha progressjoni mgħaġġla (il-bidu tas-sintomi tal-marda ta' Pompe li tipikament jidhru fl-ewwel sena tal-ħajja u b'tul ta' ħajja mistenni li jkun qasir ħafna),
English: The majority of these reactions were non-serious, mild to moderate in intensity and resolved spontaneously.
Maltese: intensità minn ħafifa sa moderata u fiequ b'mod spontanju.
English: Slightly more patients in the Myozyme group than in the placebo group experienced IARs (28% versus 23%).
Maltese: L-iktar reazzjonijiet avversi komuni osservati kienu IARs: Ftit iktar pazjenti fil-grupp ta' Myozyme milli fil-grupp tal-plaċebo kellhom IARs (28% kontra 23%).
English: Reconstitute each 50 mg vial of Myozyme with 10.3 ml water for injections.
Maltese: Irrikostitwixxi kull kunjett ta' 50 mg ta' Myozyme b'10.3 ml ta' ilma għall-injezzjonijiet.
English: • Tiredness
Maltese: • Urtikarja
English: Respiratory arrest Apnea
Maltese: Problemi respiratorji
English: See section 4
Maltese: Tabella 5:
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: Pregnancy and breast-feeding and fertility
Maltese: Tqala, treddigħ u fertilità
English: Muscle spasms Muscle twitching Myalgia not known
Maltese: Jekk tinsa tuża Myozyme