FrancophonIA/ELRC3.0 huggingface dataset:
English: For all patients weighing more than 40 kg an incremental adjustment increase in daily dose would be 1.25 mg or 0.25 mL injection volume.
Maltese: Għall-pazjenti kollha li jiżnu aktar minn 40 kg, żieda inkrementali flaġġustament fid-doża ta' kuljum tkun ta' 1.25 mg jew volum ta' injezzjoni ta'
English: Hypoglycaemia, deemed as related to metreleptin treatment, occurred in 14.2% of patients studied.
Maltese: Ipogliċemija, ikkunsidrata bħala relatata ma' trattament b'metreleptin, seħħet f'14.2% tal-pazjenti studjati.
English: Myalepta 5.8 mg powder for solution for injection metreleptin
Maltese: Myalepta 5.8 mg trab għal soluzzjoni għall-injezzjoni
English: o Ways to prevent the occurrence of medication errors - Myalepta is administered by SC injection and proper technique should be used to avoid intramuscular injection in patients with minimal SC tissue.
Maltese: Barra minn hekk, xi mediċini oħra jistgħu jaffettwaw il-mod kif taħdem din il-mediċina.
English: The weighted average daily dose (i.e., the average dose taking into account duration of treatment at different doses) for all 31 patients with baseline body weight greater than 40 kg was 7.0 mg during the first year of treatment, and 8.4 mg over the entire study period.
Maltese: Id-doża medja ta' kuljum ippiżata (weighted) (i.e., id-doża medja jekk wieħed iqis it-tul tat-trattament b'dożi differenti) għat-31 pazjent kollha b'piż tal-ġisem fil-linja bażi ta' aktar minn 40 kg kienet ta' 7.0 mg matul l-ewwel sena ta' trattament, u ta' 8.4 mg matul il-perjodu kollu tal-istudju.
English: Your doctor will monitor you for side effects.
Maltese: It-tabib tiegħek se jimmonitorjak għal effetti sekondarji.
English: Myalepta 3 mg powder for solution for injection.
Maltese: Myalepta 3 mg trab għal soluzzjoni għall-injezzjoni.
English: Excipients
Maltese: Deskrizzjoni
English: • The glass ampoule should be at a 45 degree angle to the ground.
Maltese: • Il-labra hija qasira fit-tul, u l-labra kollha għandha tidħol fil-ġilda f'angolu ta' 45 grad.
English: Table 4 Required administration syringe per Myalepta dose Syringe
Maltese: Jekk tinsa tuża Myalepta
English: ATC code: A16AB05.
Maltese: Kodiċi ATC: A16AB05.
English: MedDRA Preferred term
Maltese: Terminu preferut
English: 6MWT (meters)
Maltese: 6MWT (metri)
English: 1105 BP Amsterdam The Netherlands
Maltese: 1105 BP Amsterdam
English: Store at 2°C - 8°C.
Maltese: Aħżen f'temperatura ta' 2°C - 8°C.
English: Tel. aus dem Ausland: +49 69 305 7013
Maltese: aus dem Ausland: +49 69 305 7013
English: 2 Both groups exceeded the minimal clinically important difference (-0.24)
Maltese: Iż-żewġ gruppi qabżu d-differenza importanti klinikament minima (-0.24)
English: Vss (l/kg) t1/2 (h)
Maltese: Vss (l/kg) t1/2 (sigħat)
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Maltese: Manifattur Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, ir-Renju Unit.
English: Date of latest renewal: 10 June 2008
Maltese: Data tal-aħħar tiġdid: 10 ta' Ġunju, 2008
English: The molecule contains 6 N-linked oligosaccharide modifications sites.
Maltese: Il-molekula fiha 6 siti ta' modifikazzjonijiet N-linked ta' oligosaccharide.
English: CHAQ/HAQ Disability Index 2
Maltese: CHAQ/HAQ Indiċi tad-Diżabilità
English: EU/1/03/253/003 25 Vials
Maltese: EU/1/03/253/003 25 Kunjett
English: MedDRA System Organ Class
Maltese: Sistema tal-Klassi ta' l-Organi
English: Pack size: 1, 10 and 25 vials per carton.
Maltese: Daqs tal-pakkett: 1, 10 u 25 kunjett f'kull kaxxa tal-kartun.
English: Musculoskeletal pain
Maltese: Uġigħ muskoloskeletali
English: Apnea/Hypopnea Index (AHI)
Maltese: Indiċi ta' l-Apnea/Ipopnea (AHI)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 U of laronidase.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA 1 ml fih 100 U ta' laronidase.
English: MPS I is a heterogeneous and multisystemic disorder characterised by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyses the hydrolysis of terminal α-L-iduronic residues of dermatan sulfate and heparan sulfate.
Maltese: MPS I hu disturb eteroġenu u multisistemiku li hu kkaratterizzat mid-defiċjenza ta' α-L-iduronidase, hydrolase lisosomali li jikkatalizza l-idrolisi ta' residwi α-L-iduronic terminali ta' dermatan sulfate u heparan sulfate.
English: Aldurazyme contains sodium
Maltese: Aldurazyme fih sodium
English: Percent Predicted FVC (percentage point)
Maltese: Perċentwali mbassar FVC (punt perċentwali)
English: Severe hypersensitivity (e.g. anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8).
Maltese: Sensittività eċċessiva severa (eż. reazzjoni anafilattika) għas-sustanza attiva jew għal xi kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1(ara sezzjonijiet 4.4 u 4.8).
English: Infusion 1 Mean ± SD
Maltese: Infużjoni 1 Medja ± SD
English: EU/1/03/253/002 10 Vials
Maltese: EU/1/02/216/002 10 Kunjetti
English: Infusion 26 Mean± SD
Maltese: Infużjoni 26 Medja ± SD
English: What Aldurazyme contains - The active substance is laronidase.
Maltese: X'fih Aldurazyme - Is-sustanza attiva hi laronidase.
English: Patients were enrolled with a Forced Vital Capacity (FVC) less than 80% of the predicted value and had to be able to stand for 6 minutes and to walk 5 meters.
Maltese: Il-pazjenti rreġistrati kellhom Forced Vital Capacity (FVC) ta' inqas minn 80% tal-valur imbassar, u kellhom ikunu kapaċi jibqgħu bilwieqfa għal 6 minuti u jimxu 5 metri.
English: Several patients showed an increase in height (n=7) and weight (n=3) for age Z-score.
Maltese: Diversi pazjenti wrew żieda fit-tul (n=7) u fil-piż (n=3) għall-Punteġġ Z ta' l-età.
English: Mean change from pre-treatment baseline Percent predicted FVC (%)1
Maltese: Perċentwali mbassar FVC (%)1
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA Name and address of the manufacturer responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ir-Renju Unit Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda Fuq il-fuljett ta' tagħrif tal-prodott mediċinali għandu jkun hemm l-isem u l-indirizz tal-manifattur responsabbli għall-ħruġ tal-lott konċernat.
English: Infusion 12 Mean ± SD
Maltese: Infużjoni 12 Medja ± SD
English: ADRs to Aldurazyme reported during the Phase 3 study and its extension in a total of 45 patients age 5 years and older and treated up to 4 years are listed below using the following categories of frequency: 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: ADRs għal Aldurazyme li kienu rrappurtati matul l-istudju ta' Fażi 3 u l-estensjoni tiegħu f'total ta' 45 pazjent li kellhom 5 snin jew aktar, u li kienu kkurati sa perijodu ta' 4 snin, huma elenkati hawn taħt bl-użu tal-kategoriji tal-frekwenza li ġejjin: 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-data disponibbli).
English: Aldurazyme is an artificial enzyme called laronidase.
Maltese: Aldurazyme hu enzima artifiċjali msejħa laronidase.
English: The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute.
Maltese: L-unità ta' l-attività (U) hi definita bħala l-idrolisi ta' mikromol wieħed ta' substrat (4-MUI) kull minuta.
English: 5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).
Maltese: 5 ml ta' konċentrat għal soluzzjoni f'kunjett (ħġieġ ta' tip I) b'tapp (lastku siliconised tal-chlorobutyl) u siġill (aluminju) b'għatu flip-off (polypropylene).
English: The primary efficacy endpoints were changes in percent of predicted normal FVC and absolute distance travelled in the six-minute walk test (6MWT).
Maltese: Ir-riżultati aħħarin ta' leffikaċja kienu tibdil fil-perċentwali tal-FVC normali imbassra u d-distanza assoluta li mxew fit-test tal-mixja ta' 6 minuti (6MWT).
English: Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I).
Maltese: Aldurazyme jintuża biex jikkura pazjenti bil-marda MPS I (Mucopolysaccharidosis I).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 U (approximately 0.58 mg) of laronidase.
Maltese: 1 ml fih 100 U (madwar 0.58 mg) ta' laronidase.
English: The proportion of patients with mild left ventricular hypertrophy decreased from 53% (10/19) to 17% (3/18), and mean left ventricular mass normalized for body surface area decreased by 0.9 Z-Score (n=17).
Maltese: Il-proporzjon ta' pazjenti b'ipertrofija ventrikulari ħafifa tax-xellug naqas minn 53% (10/19) għal 17% (3/18), u l-medja tal-piż ventrikulari tax-xellug normalizzat għall-erja tas-superfiċje tal-ġisem naqas b'0.9 Punteġġ Z (n=17).
English: Urinary GAG levels decreased by 77% and 66% in the Placebo/Aldurazyme and Aldurazyme/Aldurazyme groups, respectively; at the end of the study one-third of the patients (15 of 45) had reached normal urinary GAG levels.
Maltese: Il-livelli ta' GAG fl-awrina naqsu b'77% u 66% fil-gruppi tal-Plaċebo/Aldurazyme u Aldurazyme/Aldurazyme, rispettivament; fit-tmiem ta' l-istudju, terz tal-pazjenti (15 minn 45) kienu laħqu livelli normali ta' GAG fl-awrina.
English: Erythema, facial edema, laryngeal edema, edema peripheral
Maltese: Eritema, edema fil-wiċċ, edema fil-larinġi, edema periferali
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 June 2003
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10 ta' Ġunju, 2003
English: • increased body temperature
Maltese: • żieda fit-temperatura tal-ġisem
English: Other medicines and Aldurazyme
Maltese: Aldurazyme/Aldurazyme
English: Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Maltese: Problemi tal-ħażna tal-mucopolysaccharide huma kkawżati mid-defiċjenza ta' enzimi lisosomali speċifiċi li huma meħtieġa għall-kataboliżmu ta' glycosaminoglycans (GAGs).
English: Marketing Authorisation Holder Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, L-Olanda
English: MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, L-Olanda
English: Paraesthesia, dizziness
Maltese: Rimettar, dijarea
English: The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase 3 study (treated for up to 4 years) and 35% of the patients in the under 5 study (up to 1 year of treatment).
Maltese: Il-maġġoranza ta' l-avvenimenti avversi relatati fil-provi kliniċi kienu kklassifikati bħala reazzjonijiet li kienu marbuta ma' l-infużjoni (IARs), li seħħew fi 53% tal-pazjenti fl-istudju ta' Fażi 3 (ikkurati sa perijodu ta' 4 snin) u 35% tal-pazjenti fil-kategorija ta' taħt il-5 snin (sa perijodu ta' sena ta' kura).
English: Unopened vials: 3 years
Maltese: Kunjetti mhux miftuħa: 3 snin
English: Renal elimination of laronidase is considered to be a minor pathway for clearance (see section 4.2).
Maltese: It-tneħħija renali ta' laronidase hi kkunsidrata bħala rotta minuri għat-tneħħija (ara sezzjoni 4.2).
English: Aldurazyme should not be administered simultaneously with chloroquine or procaine due to a potential risk of interference with the intracellular uptake of laronidase.
Maltese: Aldurazyme m'għandux jingħata fl-istess ħin ma' chloroquine jew procaine minħabba li riskju potenzjali ta' interferenza fl-assorbiment intraċellulari ta' laronidase.
English: Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease (see section 5.1).
Maltese: Aldurazyme hu indikat għal terapija fit-tul tas-sostituzzjoni ta' l-enzimi f'pazjenti b'dijanjosi kkonfermata ta' Mucopolysaccharidosis I (defiċjenza ta' MPS I; α-L-iduronidase) għall-kura ta' manifestazzjonijiet mhux newroloġiċi tal-marda (ara sezzjoni 5.1).
English: After intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 U/kg body weight pharmacokinetic properties were measured at Weeks 1, 12 and 26.
Maltese: Wara l-għoti fil-vini ta' laronidase b'ħin ta' l-infużjoni ta' 240 minuta u b'doża ta' 100 U/kg ta' piż tal-ġisem, il-proprjetajiet farmakokinetiċi tkejlu f'Ġimgħat 1, 12 U 26.
English: There are no clinical data on the effects of laronidase on fertility.
Maltese: M'hemm l-ebda dejta klinika dwar l-effetti ta' laronidase fuq il-fertilità.
English: The pharmacokinetic profile in patients less than 5 years old was similar to that of older and less severely affected patients.
Maltese: Il-profil farmakokinetiku f'pazjenti li kellhom inqas minn 5 snin kien simili għal dak ta' pazjenti li kellhom iktar żmien u li kienu affettwati b'mod inqas sever.
English: To address the heterogeneity in disease manifestation across patients, using a composite endpoint that summed up clinically significant changes across five efficacy variables (percent predicted normal FVC, 6MWT distance, shoulder flexion range of motion, AHI, and visual acuity) the global response was an improvement in 26 patients (58%), no change in 10 patients (22%), and a deterioration in 9 patients (20%).
Maltese: Biex jindirizza l-eteroġeneità fil-manifestazzjoni tal-marda fil-pazjenti, bl-użu ta' riżultat aħħari kompost li kien juri t-total tal-bidliet klinikament sinifikanti ta' ħames fatturi varjabbli ta' l-effikaċja (perċentwali imbassra tal-FVC normali, distanza 6MWT, medda tal-moviment tal-liwi ta' l-ispallejn, AHI, u ċarezza tal-vista), ir-rispons globali kien titjib f'26 pazjent (58%), l-ebda bidla f'10 pazjenti (22%), u deterjorament f'9 pazjenti (20%).
English: Each vial of 5 ml contains 1.29 mmol sodium.
Maltese: Kull kunjett ta' 5 ml fih 1.29 mmol ta' sodium
English: Angioneurotic edema, swelling face, urticaria, pruritus, cold sweat, alopecia, hyperhidrosis
Maltese: Edema anġjonewrotika, nefħa fil-wiċċ, urtikarja, ħakk, għaraq kiesaħ, alopeċja, iperidrosi
English: Respiratory distress, dyspnoea, cough
Maltese: Problemi respiratorji, qtugħ ta' nifs, sogħla
English: Of the 26 patients with abnormal liver volumes at pre-treatment baseline, 22 (85%) achieved a normal liver size by the end of the study.
Maltese: Mis-26 pazjenti b'volumi anormali tal-fwied fil-linja ta' qabel il-kura, 22 (85%) kisbu daqs normali tal-fwied sat-tmiem ta' l-istudju.
English: The open label extension study showed improvement and/or maintenance of these effects up to 208 weeks in the Aldurazyme/Aldurazyme group and 182 weeks in the Placebo/Aldurazyme group as indicated in the table below.
Maltese: L-istudju ta' estensjoni open label wera titjib u/jew il-manteniment ta' dawn l-effetti sa 208 ġimgħat fil-grupp ta' Aldurazyme/Aldurazyme u sa 182 ġimgħa fil-grupp tal-Plaċebo/Aldurazyme kif indikat fit-tabella hawn taħt.
English: Reduced or absent α-L-iduronidase activity results in the accumulation of the GAGs, dermatan sulfate and heparan sulfate in many cell types and tissues.
Maltese: Attività mnaqqsa jew assenti ta' α-L-iduronidase tirriżulta fl-akkumulazzjoni tal-GAGs, dermatan sulfate u heparan sulfate f'ħafna tipi ta' ċelluli u tessuti.
English: Cyanosis, hypoxia, tachypnoea, bronchospasm, respiratory arrest
Maltese: Ċijanozi, ipoksija, takipnea, bronkospażmu, waqfien tan-nifs
English: Patients who have developed antibodies or symptoms of IARs should be treated with caution when administering Aldurazyme (see sections 4.3 and 4.8).
Maltese: Pazjenti li żviluppaw antikorpi jew sintomi ta' IARs għandhom ikunu kkurati bl-attenzjoni meta jingħata Aldurazyme (ara sezzjonijiet 4.3 u 4.8).
English: Following 26 weeks of therapy, Aldurazyme-treated patients showed improved respiratory function and walking ability as compared to placebo as indicated below.
Maltese: Wara 26 ġimgħa ta' terapija, il-pazjenti li kienu kkurati b'Aldurazyme wrew funzjoni respiratorja mtejba u kapaċità tal-mixi kif imqabbla mal-plaċebo kif indikat hawn taħt.
English: All patients subsequently enrolled in an open label extension study where they all received 100 U/kg of Aldurazyme every week for an additional 3.5 years (182 weeks).
Maltese: Sussegwentement, il-pazjenti kollha rreġistraw fi studju ta' estensjoni open label fejn kollha ngħataw 100 U/Kg ta' Aldurazyme kull ġimgħa għal 3.5 snin addizzjonali (182 ġimgħa).
English: Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Maltese: Laronidase hu forma rikombinanti ta' α-L-glucosidase uman u hu magħmul minn teknoloġija tad-DNA rikombinanti bl-użu ta' koltura taċ-ċelluli mammiferi ta' l-Ovarji tal-Ħamster Ċiniż (CHO).
English: Laronidase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Maltese: Laronidase hu proteina u hu mistenni li jiddegrada metabolikament permezz ta' l-idrolisi tal-peptidi.
English: For instruction on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq dilwizzjoni tal-prodott mediċinali qabel il-amministrazzjoni, ara sezzjoni 6.6.
English: A Phase 2 open-label, 1-year study was conducted that mainly assessed the safety and pharmacokinetics of Aldurazyme in 20 patients less than 5 years of age at the time of enrolment (16 patients with the severe phenotype and 4 with the intermediate phenotype).
Maltese: Sar studju ta' sena ta' Fażi 2, open-label, li primarjament evalwa s-sigurtà u l-farmakokinetika ta' Aldurazyme f'20 pazjent li kellhom inqas minn 5 snin meta kienu rreġistrati fl-istudju (16-il pazjent b'fenotip sever u 4 b'fenotip intermedju).
English: Marketing Authorisation Holder: Genzyme Europe B.V.
Maltese: Genzyme Europe B.V.
English: In addition 60 patients in the Phase 2 and 3 studies were tested for in-vitro neutralising effects.
Maltese: Flimkien ma' dan, 60 pazjent fl-istudji ta' Fażi 2 U 3 kienu ttestjati għal effetti li jinnewtralizzaw in vitro.
English: Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Żid il-volumi mħallta ta' Aldurazyme mas-soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) ta' sodium chloride.
English: Four patients (three in the Phase 3 study and one in the Phase 2 study) showed marginal to low level in vitro inhibition of laronidase enzymatic activity, which did not appear to impact clinical efficacy and/or urinary GAG reduction.
Maltese: Erba' pazjenti (tlieta fl-istudju ta' Fażi 3 u wieħed fl-istudju ta' Fażi 2) urew inibizzjoni in vitro ta' attività enzimatika laronidase, li ma deherx li kellha impatt fuq l-effikaċja klinika u/jew tnaqqis tal-GAG urinarju.
English: The volume of distribution decreased with continued treatment, possibly related to antibody formation and/or decreased liver volume.
Maltese: Il-volum tad-distribuzzjoni naqas mat-tkomplija tal-kura, u dan kien possibbilment marbut mal-formazzjoni ta' l-antikorpi u/jew mat-tnaqqis fil-volum tal-fwied.
English: The most frequent adverse drug reactions (ADRs) were: headache, nausea, abdominal pain, rash, arthralgia, backpain, pain at extremity, flushing, pyrexia, infusion site reactions, blood pressure increased, oxygen saturation decreased,
Maltese: L-iktar reazzjonijiet avversi tal-mediċina (ADRs) frekwenti kienu: uġigħ ta' ras, nawseja, uġigħ addominali, raxx, artralġja, uġigħ fid-dahar, uġigħ fl-estremitajiet, fwawar, deni, reazzjonijiet fis-sit ta' l-infużjoni, żieda fil-pressjoni tad-demm, tnaqqis fis-saturazzjoni ta' l-ossiġnu, takikardija u tertir.
English: A phase 4 study was conducted to evaluate the pharmacodynamic effects on urinary GAGs, liver volume, and 6MWT, of different Aldurazyme dose regimens.
Maltese: Studju ta' fażi 4 sar biex jevalwa l-effetti farmakodinamiċi fuq il-GAGs urinarji, il-volum tal-fwied, u 6MWT, ta' korsijiet ta' doża differenti ta' Aldurazyme.
English: This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Maltese: Dan il-prodott mediċinali fih is-sodium u jingħata f'soluzzjoni ta' 0.9% sodium chloride ġol-vini (ara sezzjoni 6.6).
English: Antibody status should be regularly monitored and reported.
Maltese: L-istatus ta' l-antikorpi għandu jkun immonitorjat u rrappurtat regolarment.
English: In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol/ibuprofen and/or corticosteroids) and a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the previous reaction occurred.
Maltese: IAR severa waħda, għandu jkun ikkunsidrata li jingħataw mediċini ta' qabel il-kura (antistamini u paracetamol/ibuprofen u/jew kortikosterojdi), u tnaqqis fir-rata ta' l-infużjoni għal 1/2 - 1/4 tar-rata ta' l-infużjoni li fiha seħħet ir-reazzjoni ta' qabel.
English: Hypotension, pallor, peripheral coldness
Maltese: Pressjoni baxxa, sfurija, kesħa periferali
English: Almost all patients developed IgG antibodies to laronidase.
Maltese: IgG għal laronidase.
English: Based on its metabolism, laronidase is an unlikely candidate for Cytochrome P450 mediated interactions.
Maltese: Ibbażat fuq il-metaboliżmu tiegħu, laronidase mhux mistenni li jkollu interazzjonijiet medjati permezz ta' Ċitokrom P450.
English: One clinical study focussed mainly on assessing the effect of Aldurazyme on the systemic manifestations of MPS I such as poor endurance, restrictive lung disease, upper airway obstruction, reduced joint range of motion, hepatomegaly and visual impairment.
Maltese: Studju kliniku kkonċentra primarjament fuq l-evalwazzjoni ta' l-effett ta' Aldurazyme fuq il-manifestazzjonijiet sistemiċi ta' MPS I bħal ħila batuta li wieħed jissaporti t-tbatija, mard restrittiv fil-pulmun, ostruzzjoni fin-naħa ta' fuq tal-pajp tan-nifs, tnaqqis fil-medda tal-moviment tal-ġogi, epatomegalija u indeboliment tal-vista.
English: As there is little experience on resumption of treatment following prolonged interruption, use caution due to the theoretical increased risk of hypersensitivity reaction after treatment interruption.
Maltese: Minħabba li hemm ftit esperjenza dwar il-bidu mill-ġdid tal-kura wara interruzzjoni fit-tul, oqgħod attent minħabba r-riskju ogħla teoretiku ta' reazzjoni minħabba sensittività eċċessiva wara linterruzzjoni tal-kura.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001-003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/253/001-003
English: • fatigue
Maltese: • sfura
English: The mean urinary GAG level declined by 50% at Week 13 and was reduced by 61% at the end of the study.
Maltese: Il-medja tal-livell ta' GAG fl-awrina naqset b'50% f'Ġimgħa 13 u tnaqqset b'61% fit-tmiem ta' listudju.
English: This medicinal product contains 1.29 mmol sodium per vial.
Maltese: Dan il-prodott mediċinali fih madwar 1.29 mmol ta' sodium f'kull kunjett.
English: • tingling
Maltese: • tnemnim
English: Aldurazyme/Aldurazyme Placebo/Aldurazyme At 208 weeks
Maltese: Plaċebo/Aldurazym e