FrancophonIA/ELRC3.0 huggingface dataset:
English: The following side effects have been seen with Opatanol:
Maltese: L-effetti sekondarji li ġejjin kienu osservati b'OPATANOL
English: Common nasal dryness
Maltese: TA' PRODOTTI MEDIĊINALI MHUX
English: - The active substance is agalsidase alfa.
Maltese: - Is-sustanza attiva hi agalsidae alfa.
English: Agalsidase alfa is a protein.
Maltese: Agalsidase alfa huwa proteina.
English: There is a theoretical risk of decreased agalsidase alfa activity.
Maltese: Hemm riskju teoretiku ta' attività mnaqqsa ta' agalsidase alfa.
English: What Replagal is and what it is used for The active substance in Replagal is agalsidase alfa (1mg/ml).
Maltese: Is-sustanza attiva ta' Replagal hi agalsidase alfa (1 mg/ml).
English: Shire Human Genetic Therapies Inc., 205 Alewife Brook Parkway Cambridge, MA 02138
Maltese: Alewife Brook Parkway Cambridge, MA 02138
English: Information is presented by system organ class and frequency (very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100).
Maltese: L-informazzjoni qed tiġi preżentata skond il-kategorija tas-sistema ta' l-organi u l-frekwenza (komuni ħafna ≥1/10; komuni ≥1/100 sa <1/10; mhux komuni ≥1/1,000, sa <1/100).
English: Pack sizes of 1, 4 or 10 vials.
Maltese: Daqsijiet tal-pakkett ta' 1, 4 jew 10 kunjetti.
English: Sodium phosphate monobasic, monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injections
Maltese: Sodium phosphate monobasic, monohydrate polysorbate 20 sodium chloride sodium hydroxide ilma għall-injezzjonijiet
English: Table 1 System organ class
Maltese: Sistema talklassifika talorgani
English: Date of last renewal: 03/08/2006
Maltese: Data tal-ewwel awtorizzazzjoni: 03/08/2001 Data tal-aħħar tiġdid: 03/08/2006
English: Metabolism and nutrition disorders peripheral oedema
Maltese: Disturbi fil metaboliżmu u n nutrizzjoni edema periferika
English: EU/1/01/189/002
Maltese: EU/1/01/189/001 EU/1/01/189/002 EU/1/01/189/003
English: It is expected that its metabolic degradation will follow the pathways of other proteins, i.e. peptide hydrolysis.
Maltese: Huwa mistenni li d-degradazzjoni metabolika tiegħu timxi fil-mogħdijiet ta' proteini oħra, i.e. idroliżi tal-peptide.
English: - The other ingredients are: Sodium phosphate monobasic, monohydrate Polysorbate 20
Maltese: Sodium phosphate monobasic, monohydrate Polysorbate 20
English: After 12 to 18 months treatment a reduction of 5080% was observed in plasma and urine sediment.
Maltese: Wara trattament ta' bejn 12 sa 18-il xahar tnaqqis ta' 50-80 % kien osservat fil-plażma u fis-sediment ta' l-awrina.
English: Agalsidase alfa catalyses the hydrolysis of Gb3, cleaving a terminal galactose residue from the molecule.
Maltese: Agalsidase alpha jikkatalizza l-idroliżi ta' Gb3, billi jofroq residwu terminali ta' galaktosju mill-molekula.
English: It is not expected to bind to proteins.
Maltese: Mhux mistenni li jintrabat ma' proteini.
English: Hypersensitivity, including anaphylaxis, has been reported.
Maltese: Ġiet irrapportata sensittività eċċessiva, inkluż anafilassi.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Mediċini: http://www.ema.europa.eu/.
English: Table 1 lists adverse reactions reported for the 177 patients treated with Replagal in clinical trials, including 21 patients with history of end stage renal disease, 24 paediatric patients (7 to 17 years of age) and 17 female patients, and from post-marketing spontaneous reports.
Maltese: Tabella 1 telenka r-reazzjonijiet avversi rapportati fuq 177 pazjent ittrattati b'Replagal fi provi kliniċi, li jinkludu 21 pazjent bi storja ta' mard renali fl-istadju finali, 24 pazjent pedjatriku (7 - 17-il sena) u 17-il pazjent mara, u minn rapporti spontanji ta' wara t-tqegħid fis-suq.
English: The following adverse reactions have been identified for agalsidase alfa:
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati għal agalsidase alfa:
English: PHARMACEUTICAL FORM AND CONTENTS 1 x 3.5 ml concentrate for solution for infusion 4 x 3.5 ml concentrate for solution for infusion 10 x 3.5 ml concentrate for solution for infusion
Maltese: U KONTENUT Replagal 1 x 3.5 ml konċentrat għal soluzzjoni għall-infużjoni Replagal 4 x 3.5 ml konċentrat għal soluzzjoni għall-infużjoni Replagal 10 x 3.5 ml konċentrat għal soluzzjoni għall-infużjoni
English: Infusion related reactions have been experienced by 9 patients of the naïve population (31.0%) compared to 27 patients of the switched population (38.0%).
Maltese: Reazzjonijiet relatati mal-infużjoni ġew esperjenzati minn 9 pazjenti tal-popolazzjoni li qatt ma ħadet il-kura qabel (31.0%) meta mqabbel ma' 27 pazjent tal-popolazzjoni li qelbet (38.0%).
English: Other medicines and Replagal
Maltese: Mediċini oħra u Replagal
English: Patients received the recommended dosage of 0.2 mg/kg of Replagal.
Maltese: Pazjenti ngħataw id-doża rakkomandata ta' 0.2 mg/kg ta' Replagal.
English: Mean clearance of Replagal in children aged (7-11 years), in adolescents (aged 12-18 years), and adults was 4.2 ml/min/kg, 3.1 ml/min/kg, and 2.3 ml/min/kg, respectively.
Maltese: Ir-rata ta' eliminazzjoni medja ta' Replagal fit-tfal (etajiet bejn 7-11-il sena), fl-adolexxenti (etajiet 12-18-il sena), u fl-adulti kienet 4.2 ml/min/kg, 3.1 ml/min/kg, u 2.3 ml/min/kg, rispettivament.
English: 13.7% of adult patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
Maltese: Fi provi kliniċi 13.7% ta' pazjenti adulti trattati b'Replagal kellhom reazzjonijiet idjosinkratiċi relatati ma' l-infużjoni.
English: There is very limited data on pregnancies exposed to Replagal.
Maltese: Hemm dejta limitata ħafna dwar tqaliet esposti għal Replagal.
English: How to store Replagal
Maltese: X'fih Replagal
English: Method of administration For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Metodu ta' kif għandu jingħata Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Following a single intravenous dose of 0.2 mg/kg, agalsidase alfa had a biphasic distribution and elimination profile from the circulation.
Maltese: Wara doża waħda intravenuża ta' 0.2 mg/kg, agalsidase alfa kellu distribuzzjoni u profil ta' eliminazzjoni miċ ċirkulazzjoni bifażiku.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva gћas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Replagal has to be diluted in 9 mg/ml (0.9%) sodium chloride solution before use.
Maltese: Replagal għandu jiġi dilwit f'9 mg/ml (0.9%) ta' soluzzjoni ta' sodium chloride qabel ma jintuża.
English: In paediatric patients <7 yrs of age, 0/7 male patients tested positive for IgG anti-agalsidase alfa antibodies.
Maltese: F'pazjenti pedjatriċi <7 snin, ebda pazjent maskili minn sebgħa (0/7) ma ġie ttestjat pożittiv għall-antikorpi antiagalsidase alfa IgG.
English: In an open‐label randomised study, there were no statistically significant differences between adult patients treated for 52 weeks with 0.2 mg/kg intravenously every other week (n=20) and those treated with 0.2 mg/kg weekly (n=19) in mean change from baseline LVMI or other endpoints (cardiac functional status, renal function, and pharmacodynamic activity).
Maltese: Fi studju randomizzat bit-tikketta mikxufa, ma kien hemm ebda differenza statistikament sinifikanti bejn pazjenti adulti kkurati għal 52 ġimgħa b'0.2 mg/kg ġol-vini, ġimgħa iva u ġimgħa le (n=20) u dawk ikkurati b'0.2 mg/kg kull ġimgħa (n=19) fit-tibdil medju mil-LVMI tal-linja bażi jew punti tat tmiem oħrajn (status funzjonali kardijaku, funzjoni renali u attività farmakodinamika).
English: Fabry Disease is a glycosphingolipid storage disorder that is caused by deficient activity of the lysosomal enzyme α-galactosidase A, resulting in accumulation of globotriaosylceramide (Gb3 or GL-3, also known as ceramidetrihexoside (CTH)), the glycosphingolipid substrate for this enzyme.
Maltese: Il-Marda Fabry hija disturb li taffettwa l-ħażna ta' glycosphingolipid kkaġunata minn attività defiċjenti ta' l-enżima liżosomali α-galactosidase A, li tirriżulta f'akkumulazzjoni ta' globotriaosylceramide (Gb3 jew GL-3, magħruf ukoll bħala ceramidetrihexoside (CTH)), is-substrat ta' glycosphingolipid għal din l-enżima.
English: Replagal 1 mg/ml concentrate for solution for infusion Agalsidase alfa
Maltese: Replagal 1 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Clearance normalised for body weight was 2.66 and 2.10 ml/min/kg for males and females, respectively.
Maltese: Ir-rata ta' eliminazzjoni nnormalizzat għal piż korporali kienet ta' 2.66 u 2.10 ml/min/kg għall-irġiel u għan-nisa, rispettivament.
English: Pack sizes of 1, 4 or 10 vials are available.
Maltese: Daqsijiet tal-pakkett ta' 1, 4 jew 10 kunjetti huma disponibbli.
English: After 12 to 18 months of maintenance therapy, Replagal improved renal function as measured by inulin based glomerular filtration rate by 8.7 ± 3.7 ml/min.
Maltese: Wara 12 sa 18-il xahar ta' terapija ta' manteniment, Replagal tejjeb il-funzjoni renali kif imkejla b'rata ta' filtrazzjoni glomerulari bbażata fuq inulin bi 8.7 ± 3.7 ml/min (p=0.030). (p=0.030).
English: Pharmacokinetic parameters were not significantly different between male and female patients.
Maltese: Parametri farmakokinetiċi ma kinux sinifikattivament differenti bejn pazjenti nisa u rġiel.
English: Chemical and physical in use stability has been demonstrated for 24 hours at 25°C.
Maltese: Madankollu, l-istabbilità kimika jew fiżika tas-soluzzjoni dilwita ntweriet għal 24 siegħa f'temperatura ta' 25°C.
English: Serious infusion reactions have been reported uncommonly; symptoms reported include pyrexia, rigors, tachycardia, urticaria, nausea/vomiting, angioneurotic oedema with throat tightness, stridor and swollen tongue.
Maltese: Reazzjonijiet serji ta' linfużjoni ġew rapportati mhux komunement; sintomi rapportati jinkludu deni, tertir, takikardja, urtikarja, dardir/remettar, edema anġjonewrotika b'issikkar fil-griżmejn, stridor u nefħa fl-ilsien.
English: Treatment with Replagal resulted in an 11.5 g decrease in left ventricular mass as measured by magnetic resonance imaging (MRI) in the controlled study, while patients receiving placebo exhibited an increase in left ventricular mass of 21.8 g. In addition, in the first study involving 25 patients, Replagal effected a significant reduction in cardiac mass after 12 to 18 months of maintenance therapy (p<0.001).
Maltese: Trattament b'Replagal irriżulta fi tnaqqis ta' 11.5 g fil-massa ventrikulari tax-xellug kif imkejla bl-immaġini ta' resonanza manjetika (MRI) fl-istħarriġ ikkontrollat, waqt li pazjenti li kienu qegħdin jingħataw plaċebo wrew żieda fil-massa ventrikulari tax-xellug ta' 21.8 g. Barraminhekk, fl-ewwel studju li kien jinvolvi 25 pazjent, Replagal kellu effett sinifikanti fit-tnaqqis tal-massa kardijaka wara 12 sa 18-il xahar ta' terapija ta' manteniment (p<0.
English: Elimination half-lives were 108 ± 17 minutes in males compared to 89 ± 28 minutes in females and volume of distribution was approximately 17% body weight in both sexes.
Maltese: 89 ± 28 minuta fin-nisa u l-volum ta' distribuzzjoni kien bejn wieħed u ieħor fi 17% tal-piż korporali fiż-żewġ sessi.
English: Patients switched from agalsidase beta to Replagal had a safety profile consistent with that observed in other clinical experience.
Maltese: Il-pazjenti li qelbu minn agalsidase beta għal Replagal kellhom profil tas-sigurtà konsistenti ma' dak osservat f'esperjenza klinika oħra.
English: Common: may affect up to 1 in 10 people: - tingling or numbness or pain in fingers or toes, change in the taste of food, eyes tearing, blink reflex abnormal, ears ringing, shakes, prolonged sleep - palpitations, increased heart rate, increased blood pressure - cough, chest pain or tightness, hoarseness, sore or tight throat, sticky throat secretions, runny nose, cold symptoms - vomiting, abdominal pain or discomfort, diarrhoea - acne, red or itchy or mottled skin, rash at the infusion site - back or limb pain, muscle pain, joint pain, muscle and bone discomfort, swelling of the extremities or joints - feeling cold or hot, flu-like symptoms, feeling sick, feeling lack of energy
Maltese: - palpitazzjonijiet, il-qalb tħabbat aktar, pressjoni tad-demm ogħla - sogħla, uġigħ jew issikkar fis-sider, hanqa, uġigħ jew issikkar fil-griżmejn, katarru maqgħud tal-griżmejn, imnieħer iqattar, sintomi ta' riħ - remettar, uġigħ addominali jew skumdità, dijarrea - akne, ġilda ħamra, jew li ġgagħlek tħokk jew bi tbajja', raxx fis-sit ta' l-infużjoni
English: E-mail: medinfoEMEA@shire.com
Maltese: uġigħ/dwejjaq addominali
English: As with all protein pharmaceutical products, patients may develop antibodies to the protein.
Maltese: Bħal bil-prodotti farmaċewtiċi kollha li fihom il-proteina, il-pazjenti jistgħu jiżviluppaw antikorpi għall-proteina.
English: After the first 6 months of therapy mean decreases of approximately 20 - 50 % were observed in plasma, urine sediment, liver, kidney, and heart biopsy samples.
Maltese: 6 xhur ta' terapija tnaqqis medju ta' madwar 20-50% kienu osservati fil-plażma, fis-sediment ta' l-awrina, kampjuni ta' bijopsiji tal-fwied, tal-kliewi u tal-qalb.
English: *agalsidase alfa is the human protein α-galactosidase A produced in a human cell line by genetic engineering technology.
Maltese: *agalsidase alfa hija proteina α-galactosidase A umana li hija prodotta minn razza ta' ċelloli umani bit-teknoloġija tal-inġinerija ġenetika.
English: Consistent with the clinical effects of Replagal, treatment with the enzyme reduced accumulation of Gb3 in many cell types, including renal glomerular and tubular epithelial cells, renal capillary endothelial cells (cardiac and dermal capillary endothelial cells were not examined) and cardiac myocytes.
Maltese: Konsistenti ma' l-effetti kliniċi ta' Replagal, trattament bl-enżima naqqas l-akkumulazzjoni ta' Gb3 f'ħafna tipi ta' ċelloli, inklużi ċelloli renali glomerulari u tubulari epiteljali, ċelloli renali endoteljali kapillarji (ċelloli endoteljali kappilarji kardjaċi u dermali ma kinux eżaminati) u majoċiti kardijaċi.
English: Cardiac disorders tachycardia, palpitations cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischaemia, heart failure
Maltese: (fibrillazzjoni atrijali, ekstrasistoli ventrikulari, takiarritmija), iskemja mijokardijaka, kollass tal-qalb
English: The safety and efficacy of Replagal was assessed in two randomised, double blind, placebo controlled studies and open label extension studies, in a total of forty patients with a diagnosis of Fabry Disease based on clinical and biochemical evidence.
Maltese: Is-sigurtà u l-effikaċja ta' Replagal kien assaġġjat f'żewġ studji randomizzati, double blind, ikkontrollati bi plaċebo u bi studji ta' estensjoni b'tikketta miftuħa, f'total ta' erbgħin pazjent biddijanjożi tal-Marda Fabry ibbażati fuq evidenza klinika u bijokemikali.
English: Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.
Maltese: 3.5 mg/3.5 ml ta' agalsidase alfa.
English: Pharmacodynamic data suggest that at a dose of 0.2 mg/kg Replagal, the reductions in plasma Gb3 are more or less comparable between adolescents and young children (see section 5.1).
Maltese: Dejta farmakodinamika ssuġġeriet li f'doża ta' 0.2 mg/kg Replagal, it tnaqqis f'Gb3 fil-plażma huma ftit jew xejn komparabbli bejn l-adolexxenti u t-tfal żgħar (ara sezzjoni 5.1).
English: • Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
Maltese: • Iddilwa l-volum totali tal-konċentrat ta' Replagal meħtieġ f'100 ml ta' 9 mg/ml (0.9%)
English: The selection of 0.2 mg/kg dose (infused over 40 minutes) for the registration clinical studies was intended to temporarily saturate the ability of the mannose-6phosphate receptors to internalize the agalsidase alfa in the liver and allow distribution of enzyme to other relevant organ tissues.
Maltese: L-għażla tad-doża ta' 0.2 mg/kg (infuża fuq 40 minuta) għall-istudji kliniċi ta' reġistrazzjoni kienet maħsuba biex tiġi saturata temporanjament il-ħila tar-riċetturi ta' mannose-6-phosphate sabiex jinternalizzaw l agalsidase alfa fil-fwied u tiġi permessa d-distribuzzjoni tal-enzima lejn tessuti tal-organi rilevanti oħrajn.
English: As α-galactosidase A is itself an enzyme, it would be an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Maltese: Peress li α-galactosidase A hija hi stess enżima, hi tkun kandidata improbabbli għal effetti interattivi bejn mediċina u pħra li jsiru permezz ta' cytochrome P450.
English: Among 9 boys with left ventricular mass (LVMI) indexed to height2.7 within the normal range for children (<39 g/m2.7 in boys) at baseline, LVMI remained stable at levels below the left ventricular hypertrophy
Maltese: Fost 9 subien b'massa ventrikulari tax-xellug (LVMI) indiċjata sa tul2.7 fil-medda normali għat-tfal (<39 g/m2.7 fis-subien) fil-linja bażi, l-LVMI baqgħet stabbli f'livelli taħt il-limitu tal-ipertrofija ventrikulari tax-xellug (LVH) tul is-6.5 snin ta' kura.
English: Three of 8 (37.5%) paediatric patients <7 years of age experienced at least one infusion related reaction over a mean observation time of 4.2 years.
Maltese: Tliet pazjenti pedjatriċi minn 8 (37.5%) <7 snin esperjenzaw mill-inqas reazzjoni waħda relatata ma' infużjoni fuq medja ta' żmien ta' osservazzjoni ta' 4.2 snin.
English: In clinical studies, neuropathic pain medicinal products (such as carbamazepine, phenytoin and gabapentin) were administered concurrently to most patients without any evidence of interaction.
Maltese: Fi studji kliniċi, prodotti mediċinali għal uġigħ newropatiku (bħal ma huma carbamazepine, phenytoin u gabapentin) kienu mogħtija fl-istess waqt ‘il parti l-kbira tal-pazjenti mingħajr l-ebda evidenza ta' interazzjoni.
English: Children and adolescents may be more likely than adults to experience an infusion related reaction.
Maltese: Tfal u adolexxenti jistgħu jkunu aktar probabbli minn adulti li jesperjenzaw reazzjoni relatata ma' infużjoni.
English: Agalsidase alfa is unlikely to be a candidate for drug-drug interactions.
Maltese: Agalsidase alfa mhux kandidat probabbli għal effetti bejn mediċina u oħra.
English: Following six months of Replagal treatment 12 of 28 male patients showed altered pharmacokinetics including an apparent increase in clearance.
Maltese: Wara trattament ta' sitt xhur b'Replagal 12 minn 28 pazjent rġiel urew farmakokinetiċi mibdula li inkludew żieda fid-deher fir-rata ta' eliminazzjoni.
English: Longer term therapy (48-54 months) resulted in stabilisation of GFR in male patients with normal baseline GFR (≥ 90 mL/min/1.73 m2) and with mild to moderate renal dysfunction (GFR 60 to < 90 mL/min/1.73 m2), and in slowing of the rate of decline in renal function and progression to end-stage renal disease in male Fabry patients with more severe renal dysfunction (GFR 30 to < 60 mL/min/1.73 m2).
Maltese: xahar) irriżultat fi stabbilizzazzjoni ta' GFR f'pazjenti rġiel bi GFR normali fil-linja bażi ta' riferiment (≥ 90 ml/min/1.73 m2) u b'funzjoni ħazina renali minn ħafifa għal moderata (GFR 60 sa
English: Administer the infusion solution over a period of 40 minutes using an intravenous line with an integral filter.
Maltese: Agħti s-soluzzjoni ta' l-infużjoni ġol-vina permezz ta' pajp li għandu filter integrat fuq perijodu ta' 40 minuta.
English: Antibodies to the protein
Maltese: Antikorpi għall-proteina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON / 3.5 ML VIAL
Maltese: KARTUNA TA' BARRA / KUNJETT TA' 3.5 ML
English: Renal elimination of agalsidase alfa is considered to be a minor clearance pathway since pharmacokinetic parameters are not altered by impaired renal function.
Maltese: L-eliminazzjoni renali ta' agalsidase alfa hija kunsidrata li hija mogħdija ta' eliminazzjoni minuri għaliex parametri farmakokinetiċi mhumiex mibdula minn funzjoni renali imxekkla.
English: 3.5 ml of concentrate for solution for infusion in a 5 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 3.5 ml ta' konċentrat għal soluzzjoni għall-infużjoni f'kunjett ta' 5 ml (ħġieġ ta' Tip I) b'tapp (lastku butyl ta' reżina tal-fluworo), siġġill ta' parti waħda (aluminju) u għatu li jinqala bis-saba'.
English: After 6 months of therapy Replagal stabilised renal function compared with a decline in placebo treated patients.
Maltese: Wara terapija ta' 6 xhur Replagal stabbilizza l-funzjoni renali kkomparat ma' tnaqqis f'pazjenti trattati bi plaċebo.
English: This would be about 14 mg or 4 vials (glass bottles) of Replagal for an average size (70 kg) individual.
Maltese: 4 kunjetti (fliexken tal-ħġieġ) ta' Replagal għal individwu ta' daqs medju (70 kg).
English: A low titre IgG antibody response has been observed in approximately 24% of the male patients treated with Replagal.
Maltese: IgG f'titru baxx ġiet osservata f'bejn wieħed u ieħor 24% talpazjenti rġiel ittrattati b'Replagal.
English: In male paediatric Fabry patients ≥ 7 years of age, hyperfiltration can be the earliest manifestation of renal involvement in the disease.
Maltese: F'pazjenti pedjatriċi maskili ≥ 7 snin bil-marda Fabry, iperfiltrazzjoni tista' tkun l-aktar manifestazzjoni bikrija ta' involviment renali fil-marda.
English: Agalsidase alfa is a form of the human enzyme α-galactosidase.
Maltese: Agalsidase alfa hi għamla ta' l-enżima umana ta' α-galactosidase.
English: In children (aged 7-18 years), Replagal administered at 0.2 mg/kg was cleared faster from the circulation than in adults.
Maltese: Fit-tfal (etajiet bejn 7-18-il sena), Replagal mogħti f'0.2 mg/kg kien eliminat aktar malajr miċċirkulazzjoni milli fl-adulti.
English: Single doses ranging from 0.007 - 0.2 mg enzyme per kg body weight were administered to adult male patients as 20 - 40 minute intravenous infusions while female patients received 0.2 mg enzyme per kg body weight as 40 minute infusions.
Maltese: Dożi waħdanin li jvarjaw minn 0.007 - 0.2 mg enżima għal kull kg ta' piż korporali kienu mogħtija lil pazjenti adulti rġiel bħala infużjonijiet intravenużi ta' 20-40 minuta waqt li pazjenti nisa ngħataw 0.2 mg enżima għal kull kg piż korporali bħala infużjonijiet ta' 40 minuta.
English: A single patient could be affected by several adverse reactions.
Maltese: jiġi affettwat b'diversi reazzjonijiet avversi.
English: Your doctor may stop the infusion temporarily (5 - 10 min) until the symptoms go away and then begin the infusion again.
Maltese: It tabib tiegħek jista' jwaqqaf l-infużjoni temporanjament (5 - 10 min) sakemm is-sintomi jisparixxu u mbagħad jerġa' jibda l-infużjoni.
English: The presence of extensive renal damage (eGFR <60mL/min) may limit the renal response to enzyme replacement therapy.
Maltese: Il-preżenza ta' ħsara estensiva fil-kliewi (eGFR <60mL/min) tista' tirristrinġi r-rispons tal-kliewi għal terapija ta' sostituzzjoni ta' enżimi.
English: After 6 months of therapy there was a significant reduction in pain in the Replagal treated patients compared with placebo (p=0.021), as measured by the Brief Pain Inventory (a validated pain measurement scale).
Maltese: Wara 6 xhur ta' terapija kien hemm tnaqqis sinifikanti fl-uġigħ fil-pazjenti trattati b'Replagal meta mqabbel ma' plaċebo (p=0.021), kif imkejjel permezz ta' l-Inventarju ta'
English: Dilute the total volume of Replagal concentrate required in 100 ml 9 mg/ml sodium chloride solution for infusion (0.9%w/v).
Maltese: Iddilwa l-volum totali tal-konċentrat ta' Replagal meħtieġ f'100 ml ta' 9 mg/ml soluzzjoni ta'
English: After one year of treatment with agalsidase alfa 0.2 mg/kg every other week, the abnormally high eGFR decreased from 143.4 ± 6.8 to 121.3 ± 5.6 mL/min/1.73 m2 in this subgroup and these eGFRs stabilized in the normal range during 4 years of
Maltese: Wara sena kura bl-agalsidase alfa 0.2 mg/kg darba f'ġimagħtejn, l-eGFR li kien għoli b'mod abnormali naqas minn 143.4 ± 6.8 għal