FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 95 patients (73 adult and 22 paediatric) who participated in studies 032, 034, and 039 enrolled in the open label extension study and were treated with velaglucerase alfa.
Maltese: Total ta' 95 pazjent (73 adult u 22 pedjatriku) li pparteċipaw fl-istudji 032, 034 u 039 ġew irreġistrati fi studju ta' estensjoni b'tikketta mikxufa u ġew ikkurati b'velaglucerase alfa. 57 pazjent qatt ma kienu ħadu l-kura qabel.
English: After the end of the infusion, velaglucerase alfa serum concentrations fell rapidly in a monophasic or biphasic fashion with a mean t1/2 ranging from 5 to 12 minutes at doses of 15, 30, 45, and 60 Units/kg.
Maltese: Wara t-tmiem tal-infużjoni, il-konċentrazzjonijiet tas-serum ta' velaglucerase alfa niżlu malajr b'mod monofażiku jew bifażiku b'medja ta' t1/2 li tvarja bejn il-5 sa 12-il minuta għad-dożi ta' 15, 30, 45, u 60 unità/kg.
English: One vial contains 400 Units* of velaglucerase alfa**.
Maltese: Kunjett wieħed fih 400 Unità* ta' velaglucerase alfa**.
English: This increase in haemoglobin concentration was demonstrated to be clinically and statistically non-inferior to imiglucerase (mean treatment difference of change from baseline to 9 months [velaglucerase alfa - imiglucerase]: 0.135 g/dl).
Maltese: Din iż-żieda fil-konċentrazzjoni talemoglobina ntweriet li ma kinitx klinikament u statistikament inferjuri għal imiglucerase (differenza medja bejn it-trattamenti tal-bidla mil-linja bażi sa 9 xhur [velaglucerase alfa - imiglucerase]: 0.135 g/dl).
English: 63 kDa, has 497 amino acids, and the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase.
Maltese: Ilmonomeru huwa madwar 63 kDa, għandu 497 aċidi amino, u l-istess sekwenza ta' aċidu amino talenzim uman glucocerebrosidase li jseħħ b'mod naturali.
English: In Study 025EXT, 7 of 10 patients received home therapy at least once during 60 months of treatment.
Maltese: Fi Studju 025EXT, 7 minn 10 pazjenti rċevew terapija d-dar tal-inqas darba tul is-60 xahar ta' trattament.
English: 9/l), liver volume was reduced from 1.46 to 1.22 times normal (mean reduction of 17%) and spleen volume was reduced from 14.0 to 5.75 times normal (mean reduction of 50%).
Maltese: 9/l), il-volum talfwied tnaqqas minn 1.46 għal 1.22 darba n-normal (tnaqqis medju ta' 17%) u l-volum tal-milsa tnaqqas minn 14.0 għal 5.75 darba n-normal (tnaqqis medju ta' 50%).
English: OUTER CARTON - 400 UNITS (5 vial pack)
Maltese: KARTUNA TA' BARRA - 400 UNITÀ (pakkett ta' 5 kunjetti)
English: Twenty of the 94 patients (21%) who received velaglucerase alfa during clinical studies were in the paediatric and adolescent age range (4 to 17 years).
Maltese: Għoxrin mill-94 pazjent (21%) li rċevew velaglucerase alfa waqt l-istudji kliniċi kienu fil-medda ta' età pedjatrika u adolexxenti (4 sa 17-il sena).
English: Patients received either 60 Units/kg of velaglucerase alfa (N=17) or 60 Units/kg of imiglucerase (N=17) every other week.
Maltese: Il-pazjenti rċevew jew 60 unità/kg ta' velaglucerase alfa (N=17) jew 60 unità/kg ta' imunoglicerase (N=17) kull ġimgħa.
English: OUTER CARTON - 400 UNITS (25 vial pack)
Maltese: KARTUNA TA' BARRA - 400 UNITÀ (pakkett ta' 25 kunjett)
English: Use in the age group 4 to 17 is supported by evidence from controlled studies in adults and paediatric [20 of 94 (21%)] patients.
Maltese: L-użu f'dan il-grupp ta' età huwa appoġġjat b'evidenza minn studji kkontrollati f'pazjenti adulti u pedjatriċi [20 minn 94 (21%)].
English: Nervous system disorders headache, dizziness
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras, sturdament
English: Reconstituted and diluted solution for infusion:
Maltese: Soluzzjoni rikostitwita u dilwita għal infużjoni:
English: Powder for solution for infusion 1 vial
Maltese: Trab għal soluzzjoni għal infużjoni 1 kunjett
English: VPRIV 400 Units powder for solution for infusion velaglucerase alfa
Maltese: VPRIV 400 Unità trab għal soluzzjoni għal infużjoni velaglucerase alfa
English: 9/l), liver volume was reduced from 1.40 to 1.24 times normal (mean reduction of 6%) and spleen volume was reduced from 14.5 to 9.50 times normal (mean reduction of 40%).
Maltese: 9/l), il-volum tal-fwied tnaqqas minn 1.40 għal 1.24 darba n-normal (tnaqqis medju ta' 6%) u l-volum tal-milsa tnaqqas minn 14.5 għal 9.50 darba n-normal (tnaqqis medju ta' 40%).
English: After seven years of treatment, the mean increase from baseline in Z-scores were 0.7 (95% CI 0.4, 1.0) for the lumbar spine and 0.5 (95% CI 0.2, 0.7) for the femoral neck.
Maltese: Wara seba' snin ta' kura, iż-żieda medja mil-linja bażi fil-punteġġi-Z kienu 0.7 (95% CI 0.4, 1.0) għall-ispina lumbari u 0.5 (95% CI 0.2, 0.7) għall-għonq femorali.
English: Patients received doses ranging from 30 to 60 Units/kg (median dose 35 Units/kg) every other week for up to 84 months (7 years).
Maltese: Il-pazjenti rċevewdożi li jvarjaw minn 30 sa 60 unità/kg (doża medja 35 unità/kg) kull ħmistax għal 84 xahar (7 snin).
English: The total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Il-volum totali meħtieġ jiġi dilwit f'100 ml ta' soluzzjoni għal infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: The Marketing Authorisation Holder (MAH) must agree on the content and format of the educational materials for use of VPRIV in home infusion, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) irid jaqbel dwar il-kontenut u l-format tal-materjali edukattivi għall-użu ta' VPRIV f'infużjoni d-dar, li jinkludi media talkomunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħrajn tal-programm, malAwtorità Kompetenti Nazzjonali.
English: There were no statistically significant differences between velaglucerase alfa and imiglucerase in changes in platelet counts and liver and spleen volumes after 9 months of velaglucerase alfa treatment, and in the time to first haemoglobin response (defined as 1 g/dl increase from baseline).
Maltese: Ma kienx hemm differenzi statistikament sinifikanti bejn velaglucerase alfa u imiglucerase f'bidliet fl-għadd ta' plejtlits u fil-volumi tal-fwied u tal-milsa wara 9 xhur ta' trattament b'velaglucerase alfa, u fiż-żmien tal-ewwel rispons tal-emoglobina (definit bħala żieda ta' 1 g/dl millinja bażi).
English: Improvement from baseline in mean lumbar spine and femoral neck bone mineral density (BMD) Z-scores were observed at month 24 (0.4; 95% CI 0.1, 0.7) and month 33 (0.4; 95% CI 0.2, 0.6), respectively.
Maltese: .4; 95% CI 0.1, 0.7) u fix-xahar 33 (0.4; 95% CI 0.2, 0.6), rispettivament.
English: In the clinical trials, one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa.
Maltese: Fi provi kliniċi, pazjent wieħed minn 94 (1%) żviluppa antikorpi ta' klassi
English: Each vial is reconstituted using sterile water for injections:
Maltese: Kull kunjett jiġi rikostitwit permezz ta' ilma sterili għall-injezzjonijiet:
English: The accumulation of glucocerebroside in the liver and spleen leads to organomegaly.
Maltese: L-akkumulazzjoni ta' glucocerebroside fil-fwied u l-milsa twassal għal organomegalija.
English: Velaglucerase alfa 60 Units/kg given intravenously every other week demonstrated clinically meaningful increases from baseline in mean haemoglobin concentration (+2.4 g/dl) and platelet count (+50.9 x 10
Maltese: Velaglucerase alfa 60 unità/kg ġol-vina kull ġimgħa wera żidiet klinikament sinifikanti mil-linja bażi fil-konċentrazzjoni emoglobina medja (+2.4 g/dl) u fl-għadd tal-plejtlits (+50.
English: Similar treatment effects were seen through 48 months in the paediatric population who received 9 months of imiglucerase followed by velaglucerase alfa.
Maltese: Effetti simili tal-kura dehru tul 48 xahar fil-popolazzjoni pedjatrika li rċievew 9 xhur ta' imiglucerase segwit b'velaglucerase alfa.
English: After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.
Maltese: Wara preparazzjoni, it-tabib jew in-ners tiegħek jagħtik il-mediċina permezz ta' drip fil-vina (permezz ta' infużjoni ġol-vini) fuq perjodu ta' 60 minuta.
English: Gastrointestinal disorders abdominal pain/abdominal pain upper,
Maltese: Disturbi gastrointestinali uġigħ addominali/uġigħ addominali fin-naħa ta' fuq,
English: Chest discomfort
Maltese: Mhux komuni
English: Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide in the lysosome, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.
Maltese: Velaglucerase alfa jissupplimenta jew jissostitwixxi beta-glucocerebrosidase, l-enzim li jikkatalizza lidroliżi ta' glucocerebroside għal glukosju u ċeramide fil-liżosoma, billi jnaqqas l-ammont ta' glucocerebroside akkumulat u jirranġa l-patofiżjoloġija tal-marda ta' Gaucher.
English: The safety profile of VPRIV in clinical studies involving children and adolescents aged 4 to 17 years was similar to that observed in adult patients.
Maltese: Il-profil ta' sigurtà ta' VPRIV fi studji kliniċi li jinvolvu t-tfal u adoloxxenti ta' bejn 4 u 17-il sena kien simili għal dak osservat f'pazjenti adulti.
English: Extractable volume
Maltese: U KWANTITATTIVA
English: Velaglucerase alfa serum concentrations rose rapidly for the first 20 minutes of the 60-minute infusion before leveling off, and Cmax was typically attained between 40 and 60 minutes after the start of the infusion.
Maltese: Il-konċentrazzjonijiet tas-serum ta' velaglucerase alfa għolew b'mod mgħaġġel għall-ewwel 20 minuta tal-infużjoni ta' 60 minuta qabel ma ġew illivellati, u s-Cmax intlaħaq tipikament bejn l-40 u s60 minuta wara l-bidu tal-infużjoni.
English: All patients received at least 2 years of ERT and were followed for a mean of 4.5 years (min. 2.3 years, max 5.8 years).
Maltese: Il-pazjenti kollha rċevew mill-inqas sentejn ta' ERT u ġew segwiti għal medja ta' 4.5 snin (min. 2.3 snin, mass. 5.8 snin).
English: Normal spleen is defined as 0.2% of body weight; normal liver as 2.5% of body weight Note: Imputation was applied to intermittent missing data.
Maltese: Milsa normali hija definita bħala 0.2% tal-piż tal-ġisem; fwied normali bħala 2.5% tal-piż tal-ġisem Nota:
English: Musculoskeletal and connective tissue disorders bone pain, arthralgia, back pain
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi uġigħ fl-għadam, artralġja, uġigħ fiddahar
English: Patients who switched from long-term imiglucerase treatment to velaglucerase alfa (N=38)
Maltese: Pazjenti li qelbu minn kura fit-tul fuq imiglucerase għal velaglucerase alfa (N=38)
English: These medicines may include antihistamines, antipyretics, and corticosteroids.
Maltese: Dawn il-mediċini jistgħu jinkludu antistamini, antipiretiċi, u kortikosterojdi.
English: Velaglucerase alfa is manufactured to contain predominantly high-mannose-type glycans to facilitate internalisation of the enzyme by the phagocytic target cells via the mannose receptor.
Maltese: Velaglucerase alfa jiġi manifatturat biex iżomm glikani tat-tip mannose għoli b'mod predominanti sabiex jiffaċilita l-internalizzazzjoni tal-enzim miċċelloli fagoċitiċi fil-mira permezz tar-reċettur mannose.
English: The recommended dose is 60 Units/kg given every other week.
Maltese: Dożi ogħla minn 60 unità/kg ma ġewx studjati.
English: The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia/body temperature increased (see section 4.4 for further information).
Maltese: Is-sintomi tarreazzjonijiet relatati mal-infużjoni li l-aktar li ġew osservati kienu: uġigħ ta' ras, sturdament, pressjoni baxxa, pressjoni għolja, nawsja, għeja/astenja, u deni/żieda fit-temperatura tal-ġisem (ara sezzjoni 4.4 għal aktar informazzjoni).
English: Fertility Animal studies show no evidence of impaired fertility.
Maltese: Fertilità Studji fuq il-bhejjem ma juru l-ebda evidenza dwar indeboliment fil-fertilità.
English: The total volume of infusion should be delivered over a period of 60 minutes.
Maltese: Il-volum totali talinfużjoni għandu jingħata fuq perijodu ta' 60 minuta.
English: OUTER CARTON - 400 UNITS (single vial pack)
Maltese: KARTUNA TA' BARRA - 400 UNITÀ (pakkett ta' kunjett wieħed)
English: VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.
Maltese: VPRIV huwa indikat għat-terapija ta' sostituzzjoni tal-enzimi (ERT) fit-tul f'pazjenti bit-tip 1 talmarda ta' Gaucher.
English: An IRR often appears as a hypersensitivity reaction.
Maltese: IRR ta' spiss tidher bħala reazzjoni ta' sensittività eċċessiva.
English: Therefore, it was not possible to evaluate the effect of antibody response on the pharmacokinetic profile of velaglucerase alfa.
Maltese: Għaldaqstant, ma kienx possibbli li jiġi evalwat l-effett tar-rispons tal-antikorpi fuq il-profil farmakokinetiku ta' velaglucerase alfa.
English: There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease.
Maltese: Ma kien hemm l-ebda differenza farmakokinetika apparenti bejn il-pazjenti rġiel u dawk nisa bilmarda ta' Gaucer tat-tip 1.
English: Velaglucerase alfa was initially administered in a dose-escalating fashion in the first 3 patients (15, 30, 60 Units/kg) and the 9 remaining patients began treatment with 60 Units/kg.
Maltese: Għall-ewwel, Velaglucerase alfa ngħata b'mod li d-doża tiżdied fl-ewwel 3 pazjenti (15, 30, 60 unità/kg) u d-9 pazjenti li kien fadal bdew it-trattament b'60 unità/kg.
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Maltese: Reazzjoni allerġika qawwija għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: In Study 034, 25 of 40 patients received home therapy at least once during the 12-month study.
Maltese: Fi Studju 034EXT, 25 minn 40 pazjent irċevew terapija d-dar tal-inqas darba tul it-12-il xahar ta' studju.
English: Table 1: Adverse reactions reported with VPRIV observed in patients with type 1 Gaucher disease Italic text denotes post-marketing event.
Maltese: Tabella 1: Reazzjonijiet avversi rappurtati b'VPRIV f'iktar minn pazjent wieħed bil-marda ta' Gaucher tat-tip 1 It-test b'tipa korsiva juri avveniment li seħħ wara t-tqegħid fis-suq.
English: VPRIV is supplied in a vial as a packed powder which is mixed with sterile water and further diluted in sodium chloride 9 mg/ml (0.9%) solution prior to intravenous infusion.
Maltese: VPRIV jiġi f'kunjett bħala trab ippakkjat li jitħallat ma' ilma sterili u jiġi dilwit iktar f'soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) qabel infużjoni ġol-vini.
English: Patients treated with imiglucerase for 9 months and then velaglucerase alfa for 15 months (N=16)
Maltese: Pazjenti kkurati b'imiglucerase għal 9 xhur u mbagħad velaglucerase alfa għal 15-il xahar (N=16)
English: Normalized Liver Volume* (%BW) Normalized Spleen Volume* (%BW) Excludes patients with splenectomy.
Maltese: Volum tal-Fwied Normalizzat* (%BW) Volum tal-Milsa Normalizzat * (%BW) Jeskludi pazjenti bi splenektomija N=30, 6 u 34 għat-3 gruppi ta' hawn fuq.
English: The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received velaglucerase alfa at doses ranging from 15 to 60 Units/kg every other week in 5 clinical studies.
Maltese: Id-dejta deskritta hawn taħt tirrifletti l-espożizzjoni ta' 94 pazjent bil-marda ta' Gaucher tat-tip 1 li rċevew velaglucerase alfa f'dożi li jvarjaw minn 15 sa 60 unità/kg ġimgħa iva u ġimgħa le f'5 studji kliniċi.
English: Study 039 was a 9-month, randomized, double-blind, non-inferiority, active-comparator (imiglucerase) controlled, parallel-group efficacy study in 34 patients aged 2 years and older who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry).
Maltese: L-Istudju 039 kien studju tal-effikaċja li dam 9 xhur, fortuwitu, mingħajr l-ebda għarfien tal-mediċina min-naħa tal-pazjenti u tal-istudjużi, ta' non-inferjorità, ikkontrollat minn komparatur attiv (imiglucerase), fuq grupp parallel b'34 pazjent li kellhom sentejn u aktar li ma kinux irċevew trattament ERT (definiti bħala li ma ġewx ittrattati b'ERT għal mill-inqas 12-il xahar qabel ma daħlu fl-istudju).
English: Patients were between 4 and 71 years old at the time of first treatment with VPRIV, and included 46 male and 48 female patients.
Maltese: Il-pazjenti kellhom bejn 4 u 71 sena fiż-żmien tal-ewwel trattament b'VPRIV, u kienu jinkludu 46 raġel u 48 mara.
English: Patients transferring from a dose of <15 Units/kg imiglucerase were administered 15 Units/kg of velaglucerase alfa.
Maltese: Pazjenti li kienu qegħdin jinqelbu minn doża ta' <15 Unità/kg imiglucerase ingħataw 15 Unità/kg ta' velaglucerase alfa.
English: Infusion-related-reactions
Maltese: Reazzjonijiet relatati mal-infużjoni
English: The most frequently reported symptoms of hypersensitivity include nausea, rash dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache.
Maltese: L-aktar sintomi rrappurtati b'mod frekwenti ta' sensittività eċċessiva jinkludu dardir, qtugħ ta' nifs, raxx, uġigħ fid-dahar, skonfort fis-sider (li jinkludi tagħfis fis-sider), urtikarja, artralġja, u wġigħ ta' ras.
English: Deposits in the bone marrow and splenic sequestration lead to clinically significant anaemia and thrombocytopenia.
Maltese: Id-depożiti filmudullun u s-sekwestru tal-milsa jwasslu għal anemija u tromboċitopenja klinikament sinifikanti.
English: Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week.
Maltese: Studji kliniċi evalwaw dożi li jvarjaw minn 15 sa 60 unità/kg kull ħmistax.
English: Vascular disorders hypertension, hypotension, flushing
Maltese: Disturbi vaskulari pressjoni għolja, pressjoni baxxa, fwawar
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials and the total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Il-volum ikkalkolat tal-prodott mediċinali jinġibed min-numru xieraq ta' kunjetti u l-volum totali meħtieġ jiġi dilwit f'100 ml ta' soluzzjoni għal infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: The maximum dose of velaglucerase alfa in clinical studies was 60 Units/kg.
Maltese: Id-doża massima ta' velaglucerase alfa fl-istudji kliniċi kienet ta' 60 unità/kg.
English: Vial size
Maltese: Tużax VPRIV
English: Clinically meaningful improvements from baseline were observed in haemoglobin concentration and platelet counts as early as 3 months and in liver and spleen volumes at both 6 months and 9 months following the initiation of treatment with velaglucerase alfa.
Maltese: Titjib klinikament sinifikanti mil-linja bażi ġie osservat fil-konċentrazzjoni tal-emoglobina u fl-għadd ta' plejtlits sa minn 3 xhur wara u fil-volumi tal-fwied u tal-milsa kemm wara 6 xahar kif ukoll wara 9 xhur mill-bidu tat-trattament b'velaglucerase alfa.
English: The safety profile in these patients was similar to that observed in other clinical trials.
Maltese: Il-profil ta' sigurtà f'dawn il-pazjenti kien simili għal dak osservat fi provi kliniċi oħrajn.
English: Adverse reactions reported in patients with type 1 Gaucher disease are listed in Table 1.
Maltese: Ir-reazzjonijiet avversi li ġew rappurtati f'pazjenti bil-marda ta' Gaucher tat-tip 1 huma elenkati fitTabella 1.
English: You may need to read it again.
Maltese: Għandha tingħata permezz ta' filtru ta' 0.
English: VPRIV contains sodium
Maltese: Kif jidher VPRIV u l-kontenut tal-pakkett
English: Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase.
Maltese: Il-marda ta' Gaucher hija disturb reċessiv awtosomali kkawżat minn mutazzjonijiet fil-ġene GBA li jirriżulta f'nuqqas tal-enzim beta-glucocerebrosidase liżosomali.
English: After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa.
Maltese: Wara rikostituzzjoni, 1 ml tas-soluzzjoni fih 100 Unità ta' velaglucerase alfa.¶
English: In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs.
Maltese: F'dan id-disturb ta' ħażna liżosomali (LSD), il-karatteristiċi kliniċi jirriflettu t-tqassim taċċelloli Gaucher fil-fwied, fil-milsa, fil-mudullun, fl-iskeletru, u fil-pulmuni.
English: By month 57, 8 out of the 8 patients had achieved a reduction of at least 2 points in the lumbar spine Bone Marrow Burden (BMB) score as assessed by MRI scan.
Maltese: Sa xahar 57, 8 pazjenti minn 8 kisbu tnaqqis ta' mill-inqas 2 punti fil-punteġġ tal-Piż tal-Mudullun talIspina Lumbari (BMB - Bone Marrow Burden) kif ivvalutat minn sken tal-MRI. Ġie osservat titjib mil-linja bażi fil-punteġġi-Z medji tad-densità minerali tal-għadam (BMD - bone mineral density) talispina lumbari u tal-għonq femorali fix-xahar 24 (0
English: One vial contains 400 Units of velaglucerase alfa.
Maltese: VPRIV 400 unità trab għal soluzzjoni għal infużjoni velaglucerase alfa
English: Velaglucerase alfa increases haemoglobin concentration and platelet counts and reduces liver and spleen volumes in patients with type 1 Gaucher disease.
Maltese: Dawn l-effetti tal-kura fuq l-emoglobina, l-għadd ta' plejtlits, volum tal-organi, densità minerali talgħadam u t-tul inżammu sa tmiem l-istudju.
English: Eye disorders vision blurred
Maltese: ** prodott f'linja ta' ċelloli fibroblast
English: Study in patients switching from imiglucerase treatment to VPRIV Study 034 was a 12-month, open-label safety study in 40 patients aged 2 years and older who had been receiving treatment with imiglucerase at doses ranging from 15 to 60 Units/kg for a minimum of 30 consecutive months.
Maltese: Studju fuq pazjenti li qalbu minn trattament b'Imiglucerase għal VPRIV L-Istudju 034 kien studju ta' sigurtà li dam 12-il xahar, bl-għarfien tal-mediċina fuq 40 pazjent ta' sentejn u aktar li kienu qegħdin jirċievu trattament b'imiglucerase f'dożi li jvarjaw bejn il-15 u s60 unità/kg għal minimu ta' 30 xahar konsekuttiv.
English: No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa.
Maltese: L-ebda wieħed mis-suġġetti fl-istudji farmakokinetiċi ma nstab pożittiv għal antikorpi anti-velaglucerase alfa fil-jiem ta' evalwazzjoni farmakokinetika.
English: Skin and subcutaneous tissue disorders rash, urticaria, pruritus
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: Patients were randomized to receive velaglucerase alfa at a dose of either 45 Units/kg (N=13) or 60 Units/kg (N=12) every other week.
Maltese: Il-pazjenti ntgħażlu b'mod fortuwitu sabiex jirċievu velaglucerase alfa f'doża ta' 45 unità/kg (N=13) jew ta' 60 unità/kg (N=12) kull ħmistax.
English: • Annex: SmPC; Healthcare Professional Reconstitution Guide, Infusion diary
Maltese: • Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni;
English: Hypersensitivity reactions, including symptoms consistent with anaphylaxis, have been reported in patients in clinical studies and in post-marketing experience.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, li jinkludu sintomi konsistenti ma' anafilassi, ġew irrapportati f'pazjenti fi studji kliniċi u fl-esperjenza wara t-tqegħid fis-suq.
English: The active substance of VPRIV is velaglucerase alfa, which is produced by gene activation technology in a human cell line.
Maltese: Is-sustanza attiva ta' VPRIV hija velaglucerase alfa, li tiġi prodotta permezz ta' teknoloġija ta' attivazzjoni tal-ġeni f'linja ta' ċelloli tal-bniedem.
English: Posology The recommended dose is 60 Units/kg administered every other week.
Maltese: Pożoloġija Id-doża rakkomandata hija ta' 60 unità/kg amministrata ġimgħa iva u ġimgħa le.
English: No patients developed IgE antibodies to velaglucerase alfa.
Maltese: Ebda pazjent ma żviluppa antikorpi IgE għal velaglucerase alfa.