FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution each millilitre (mL) contains 20 mg polatuzumab vedotin.
Maltese: Iddetermina l-volum tas-soluzzjoni rikostitwita ta' 20 mg/mL meħtieġ abbażi tad-doża meħtieġa (ara hawn taħt):
English: In the Polivy plus BR arm, the median onset to first event of PN was 1.8 months, and 61.1% of patients with PN events reported event resolution.
Maltese: Fil-grupp ta' Polivy flimkien ma' BR, il-bidu medjan sal-ewwel avveniment ta' PN kien ta' 1.8 xhur, u 61.1% tal-pazjenti b'avvenimenti ta' PN irrappurtaw li l-avveniment għadda.
English: However, treatment of pregnant rats with MMAE at 0.2 mg/kg caused embryolethality and foetal malformations (including protruding tongue, malrotated limbs, gastroschisis, and agnathia).
Maltese: Madankollu, it-trattament ta' firien tqal b'MMAE b'doża ta' 0.2 mg/kg ikkawża mewt tal-embriju u malformazzjonijiet fil-fetu (inklużi lsien li joħroġ 'il barra, dirgħajn u riġlejn mhux imdawra sew, intestini li joħorġu 'l barra mill-ġisem, u agnatja).
English: In vivo studies in rats dosed with polatuzumab vedotin (radiolabel on MMAE) demonstrate that the majority of radioactivity is excreted in faeces and the minority of radioactivity is excreted in urine.
Maltese: Studji in vivo f'firien li ngħataw doża ta' polatuzumab vedotin (radjutikkettar fuq MMAE) juru li l-maġġoranza tar-radjuattività tiġi eliminata fl-ippurgar u l-minoranza tar-radjuattività tiġi eliminata fl-awrina.
English: Very common (may affect more than 1 in 10 people)
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni)
English: Polivy has not been evaluated in patients with HIV.
Maltese: Polivy ma ġiex evalwat f'pazjenti bl-HIV.
English: Polivy, bendamustine and rituximab can be administered in any order on Day 1 of each cycle.
Maltese: Polivy, bendamustine u rituximab jistgħu jingħataw fi kwalunkwe ordni fil-Jum 1 ta' kull ċiklu.
English: MMAE is a weak time-dependent inhibitor of CYP3A4/5 but does not competitively inhibit CYP3A4/5 at clinically relevant concentrations.
Maltese: Studji in vitro jindikaw li MMAE hija substrat għal CYP3A4/5 iżda ma tinduċix enzimi maġġuri ta' CYP. MMAE hija inibitur dgħajjef li jiddependi miż-żmien ta' CYP3A4/5 iżda ma tinibixxix lil CYP3A4/5 b'mod kompetittiv f'konċentrazzjonijiet klinikament rilevanti.
English: • severe infections
Maltese: • infezzjonijiet severi
English: Do not shake
Maltese: DATA TA' SKADENZA
English: Patients should be monitored closely for TLS during treatment with Polivy.
Maltese: Ilpazjenti għandhom jiġu mmonitorjati mill-qrib għal TLS waqt it-trattament b'Polivy.
English: General disorders and administration site conditions Very common fatigue, pyrexia, asthenia, chills Investigations
Maltese: Komuni problemi fil-mixi, paraestesija, ipoestesija
English: Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 6.
Maltese: L-istabbiltà kimika u fiżika tas-soluzzjoni għall-infużjoni ppreparata ġiet murija għat-tul ta' żmien elenkat fit-Tabella 6.
English: NAME OF THE MEDICINAL PRODUCT Polivy 140 mg powder for concentrate for solution for infusion polatuzumab vedotin
Maltese: Bħal fil-każ tal-proteini terapewtiċi kollha, hemm il-potenzjal għal rispons immuni f'pazjenti ttrattati b'polatuzumab vedotin.
English: No dedicated clinical drug-drug interaction studies with polatuzumab vedotin in humans have been conducted.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Polivy was given intravenously at 1.8 mg/kg administered on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6.
Maltese: Polivy ingħata fil-vini b'doża ta' 1.8 mg/kg mogħtija fil-Jum 2 taċ-Ċiklu 1 u fil-Jum 1 taċ-Ċikli 2-6.
English: Tumour lysis syndrome (TLS)
Maltese: Effett tossiku fuq l-embriju u l-fetu
English: There are insufficient data to assess the impact of severe renal impairment (CrCL 15-29 mL/min, n = 3) on PK. No data are available in patients with end-stage renal disease and/or who are on dialysis.
Maltese: M'hemmx biżżejjed data biex jiġi evalwat l-impatt ta' indeboliment sever tal-kliewi (CrCL 15-29 mL/min, n = 3) fuq il-PK.
English: There are insufficient data to assess the impact of moderate hepatic impairment (total bilirubin > 1.5-3×ULN, n = 2) on PK. No data are available in patients with severe hepatic impairment or liver transplantation.
Maltese: M'hemmx biżżejjed data biex jiġi evalwat l-impatt ta' indeboliment moderat tal-fwied (bilirubina totali > 1.5-3×ULN, n = 2) fuq il-PK.
English: Patients experiencing new or worsening PN may require a delay, dose reduction, or discontinuation of Polivy (see section 4.2).
Maltese: Pazjenti li jkollhom PN ġdida jew li taggrava jistgħu jeħtieġu ttardjar, tnaqqis fid-doża, jew waqfien ta' Polivy (ara sezzjoni 4.2).
English: Drug interactions of rituximab and bendamustine in combination with polatuzumab vedotin
Maltese: L-effetti sekondarji li ġejjin ġew irrappurtati b'din il-mediċina:
English: • if a bendamustine dose reduction to 50 mg/m2 has already occurred, discontinue all treatment.
Maltese: • jekk diġà sar tnaqqis fid-doża ta' bendamustine għal 50 mg/m waqqaf it-trattament kollu.
English: • itchiness
Maltese: • sogħla
English: Prophylactic granulocyte colony stimulating factor (G-CSF) administration was required in the clinical development and should be considered.
Maltese: L-għoti profilattiku ta' fattur li jistimola l-kolonja tal-granuloċiti (G-CSF - granulocyte colony stimulating factor) kien meħtieġ waqt l-iżvilupp kliniku u għandu jiġi kkunsidrat.
English: The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanized immunoglobulin G1 monoclonal antibody via a cleavable linker.
Maltese: Il-molekula ta' polatuzumab vedotin tikkonsisti f'MMAE marbuta b'mod kovalenti ma' antikorp monoklonali tal-immunoglobulina G1 umanizzata permezz ta' sustanza li torbot li tista' tinqasam.
English: Testicular seminiferous tubule degeneration did not reverse following a 6-week treatment-free period and correlated with decreased testes weight and gross findings at recovery necropsy of small and/or soft testes in males given ≥ 2 mg/kg.
Maltese: Deġenerazzjoni tat-tubuli seminiferużi testikulari ma reġgħetx lura għan-normal wara perjodu ta' 6 ġimgħat mingħajr trattament u kienet ikkorrelatata ma' tnaqqis fil-piż tat-testikoli u sejbiet kompluti waqt nekroskopija ta' rkupru ta' testikoli żgħar u/jew rotob f'irġiel li ngħataw ≥ 2 mg/kg.
English: Tumour lysis syndrome
Maltese: Effett tossiku fuq il-ġeni
English: Patients should be monitored for IRRs/hypersensitivity reactions during the infusion and for at least 90 minutes following completion of the initial dose.
Maltese: Ilpazjenti għandhom jiġu mmonitorjati għal IRRs/reazzjonijiet ta' sensittività eċċessiva matul linfużjoni u għal mill-inqas 90 minuta wara t-tlestija tad-doża inizjali.
English: • sore throat
Maltese: • deni jew sirdat
English: • painful rash
Maltese: • raxx li juġgħek
English: If no infusionrelated reaction occurs, subsequent infusions may be administered over 30 minutes.
Maltese: Jekk ma sseħħx reazzjoni relatata mal-infużjoni, l-infużjonijiet sussegwenti jistgħu jingħataw fuq medda ta' 30 minuta.
English: If you are a woman of childbearing age, you must use effective contraception during treatment and for 9 months after the last dose of Polivy.
Maltese: Jekk inti mara f'età li tista' toħroġ tqila, għandek tuża kontraċezzjoni effettiva waqt it-trattament u għal 9 xhur wara l-aħħar doża ta' Polivy.
English: Gastrointestinal toxicity events were reported in 80.0% of patients in the Polivy plus BR arm compared to 64.1% of patients in the BR arm.
Maltese: 0% tal-pazjenti filgrupp ta' Polivy flimkien ma' BR meta mqabbla ma' 64.1% tal-pazjenti fil-grupp ta' BR.
English: This was a reduction of 55%.
Maltese: Dan ifisser tnaqqis ta' 55%.
English: The full EPAR for Synagis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It contains the active substance palivizumab.
Maltese: Fih issustanza attiva palivizumab.
English: The active substance in Synagis, palivizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Synagis, palivizumab, hu antikorp monoklonali.
English: This is a summary of the European public assessment report (EPAR) for Synagis.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Synagis.
English: Palivizumab has been designed to attach to a protein called ‘fusion protein A' on the surface of RSV.
Maltese: Palivizumab ġie ddisinjat biex jeħel ma' proteina magħrufa bħala ‘proteina tal-fużjoni A' fuq is-superfiċje tal-RSV.
English: In children born with heart disease, there was a reduction of 45%.
Maltese: Fit-tfal b'mard konġenitali tal-qalb, kien hemm tnaqqis ta' 45%.
English: Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.
Maltese: Synagis jingħata darba fix-xahar meta jkun hemm riskju ta' infezzjoni tal-RSV fil-komunità: fl-emisfera tat-tramuntana, dan idum minn Novembru sa April.
English: The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season.
Maltese: L-istudju ewlieni fuq Synagis sar fuq 1,502 itfal b'riskju għoli u qabbel l-effikaċja ta' Synagis ma' dik ta' plaċebo (trattament finta) matul staġun wieħed tal-RSV.
English: Why has Synagis been approved?
Maltese: Għaliex ġie approvat Synagis?
English: The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash.
Maltese: L-aktar effett sekondarju komuni b'Synagis (li deher f'bejn pazjent wieħed u 10 fost 100) huwa d-deni u raxx.
English: Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo.
Maltese: Synagis kien iktar effikaċi mill-plaċebo biex inaqqas l-għadd ta' tfal li kellhom jiddaħħlu l-isptar minħabba infezzjoni bl-RSV: waqt l-istudju 5% tat-tfal li kienu ngħataw Synagis kellhom jiddaħħlu lisptar minħabba infezzjoni tal-RSV, meta mqabbla ma' 11% ta' dawk li kienu ngħataw plaċebo.
English: Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.
Maltese: Synagis jintuża għall-prevenzjoni ta' infezzjonijiet serji fil-parti ta' isfel tas-sistema tan-nifs (filpulmun) ikkawżati minn vajrus respiratorju sinsitiku (RSV respiratory syncytial virus ) li minħabba f'hekk il-pazjent ikollu jiddaħħal l-isptar.
English: Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease.
Maltese: Sar ukoll studju ieħor biex iqabbel Synagis ma' plaċebo f'1,287 tifel u tifla li twieldu b'mard tal-qalb.
English: • children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
Maltese: • tfal ta' inqas minn sentejn li jkunu ħadu trattament għad-displażija bronkopulmonari (tessut anomalu fil-pulmun, li ġeneralment jinstab fi trabi li jkunu twieldu qabel iż-żmien) fl-aħħar sitt xhur;
English: If possible, the first dose should be given before this season starts.
Maltese: Jekk ikun possibbli, l-ewwel doża għandha tingħata qabel ma jibda l-istaġun.
English: What is Synagis?
Maltese: X'inhu Synagis?
English: For the full list of all side effects reported with Synagis, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati ma' Synagis, ara l-fuljett ta' tagħrif.
English: What is the risk associated with Synagis?
Maltese: X'riskji huma assoċjati ma' Synagis?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).
Maltese: Antikorp monoklonali hu antikorp (tip ta' proteina) li jkun ġie ddisinjat biex jagħraf u jeħel ma' struttura speċifika (magħrufa bħala antiġen).
English: Patients generally receive a total of five monthly injections into the thigh muscle.
Maltese: Il-pazjenti ġeneralment jirċievu total ta' ħames injezzjonijiet fil-muskolu talkoxxa.
English: Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised' monoclonal antibodies.
Maltese: Synagis ma għandux jintuża minn persuni ipersensittivi (allerġiċi) għal palivizumab jew għal xi sustanza oħra tiegħu, jew għal antikorpi monoklonali “umanizzati” oħra.
English: This helps to prevent RSV infection.
Maltese: Dan jgħin biex tiġi pprevenuta infezzjoni mill-RSV.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synagis on 13 August 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Synagis valida fl-Unjoni Ewropea kollha fit-13 ta' Awwissu 1999.
English: Other information about Synagis
Maltese: Kif jintuża Synagis?
English: How has Synagis been studied?
Maltese: Kif ġie studjat Synagis?
English: Synagis is a powder and solvent that are made up into a solution for injection.
Maltese: Synagis huwa trab u solvent li jitħalltu flimkien sabiex jiffurmaw soluzzjoni għall-injezzjoni.
English: 400 Units
Maltese: 400 unità
English: - The active substance is velaglucerase alfa.
Maltese: - Is-sustanza attiva hi velaglucerase alfa.
English: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 USA
Maltese: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 Stati Uniti tal-Amerika
English: • Organisation of home infusion/preparation of infusion;
Maltese: • Organizzazzjoni tal-infużjoni d-dar/preparazzjoni tal-infużjoni;
English: Overall velaglucerase alfa group (N=39)
Maltese: Grupp velaglucerase alfa ġenerali (N=39)
English: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 USA
Maltese: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 Stati Uniti tal-Amerika
English: Velaglucerase alfa is a glycoprotein.
Maltese: Velaglucerase alfa huwa glikoproteina.
English: Immune system disorders hypersensitivity reactions (includes dermatitis allergic and anaphylactic/anaphylactoid reactions)
Maltese: Disturbi fis-sistema immuni reazzjonijiet ta' sensittività eċċessiva (jinkludu dermatite allerġika u reazzjonijiet anafilattiċi/anafilattojde)
English: Pack sizes of 1, 5 and 25 vials.
Maltese: Daqsijiet tal-pakkett ta' 1, 5 u 25 kunjett.
English: VIAL - 400 UNITS
Maltese: KUNJETT - 400 UNITÀ
English: Extension Study 044
Maltese: Studju ta' Estensjoni 044
English: Frequency is defined as very common (1/10), common (1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Maltese: Il-frekwenza hija definita bħala komuni ħafna (1/10), komuni (1/100 sa <1/10), u mhux komuni (≥1/1,000 sa <1/100).
English: Citric acid monohydrate
Maltese: Sodium citrate dihydrate Citric acid monohydrate
English: Mean change from baseline (95% CI)
Maltese: Bidla medja millinja bażi (95% CI)
English: Table 2: Results at 24 months - Change from Baseline - Study 044 ITT Population Clinical Parameters
Maltese: Tabella 2: Riżultati f'24 xahar - Tibdil mil-Linja Bażi - Popolazzjoni ITT tal-Istudju 044 Parametri Kliniċi
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C under protection from light.
Maltese: Intweriet stabilità kimika u fiżika fl-użu għal 24 siegħa f'2°C sa 8°C bi protezzjoni mid-dawl.
English: Store in the refrigerator (2ºC - 8ºC).
Maltese: Aħżen fi friġġ (2 ºC - 8ºC).
English: Elderly (≥65 years old)
Maltese: L-anzjani (≥65 sena)
English: Cartons with 1, 5 or 25 vials.
Maltese: Kartun b'1, 5 jew 25 kunjett.
English: Among 31 treatment-naïve adult patients treated with velaglucerase alfa, the mean lumbar spine BMD Z-score at baseline was -1.820 (95% CI: -2.21, -1.43) and increased by 0.62 (95% CI: 0.39, 0.84) from baseline following 24 months of treatment with velaglucerase alfa.
Maltese: Fost il-31 pazjent adult li qatt ma ħadu l-kura b'velaglucerase alfa qabel, ilpunteġġ Z tal-BMD tal-ispina lumbari medju kien -1.820 (95% CI: -2.21, -1.43) u żdied b'0.62 (95% CI: 0.39, 0.84) mil-linja bażi wara 24 xahar ta' kura b'velaglucerase alfa.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB10.
Maltese: Prodotti oħrajn tal-apparat alimentari u tal-metaboliżmu - enzimi, Kodiċi ATC:
English: Haemoglobin concentration (g/dL) Platelet count (x 10
Maltese: Konċentrazzjoni talemoglobina (g/dL) Għadd tal-plejtlits (x 9/L)
English: - The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 “VPRIV contains sodium”).
Maltese: - Is-sustanzi l-oħrajn huma sucrose, sodium citrate dihydrate, citric acid monohydrate, u polysorbate 20 (ara s-sezzjoni 2 “VPRIV fih sodju”).
English: *An enzyme unit is defined as the amount of enzyme that is required to convert one micromole of p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at 37ºC.
Maltese: *Unità ta' enzim hija definita bħala l-ammont ta' enzim li huwa meħtieġ biex micromole wieħed ta' p-nitrophenyl β-D-glucopyranoside jinqaeb għal p-nitrophenol kull minuta f'37ºC.
English: • Infusion diary;
Maltese: • Djarju tal-infużjoni;
English: The high clearance of velaglucerase alfa from serum (mean 6.7 to 7.6 ml/min/kg) is consistent with the rapid uptake of velaglucerase alfa into macrophages via mannose receptors.
Maltese: L-eliminazzjoni għolja ta' velaglucerase alfa mis-serum (medja ta' 6.7 sa 7.6 ml/min/kg fl-Istudju 032) hija konsistenti mat-teħid rapidu ta' velaglucerase alfa f'makrofaġi permezz ta' riċetturi mannose.
English: The effect on height was assessed in the study 044 (see section 5.1, Extension Study 044).
Maltese: L-effett fuq it-tul ġie vvalutat fl-istudju 044 (ara sezzjoni 5.1, Studju ta' Estensjoni 044).
English: Contains sodium, see leaflet for further information.
Maltese: Fih sodium, ara l-fuljett għal aktar informazzjoni.
English: Powder for solution for infusion 25 vials
Maltese: Trab għal soluzzjoni għal infużjoni. 25 kunjett
English: Velaglucerase alfa exhibited an approximately linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased approximately proportional to the dose over the dose range 15 to 60 Units/kg.
Maltese: Velaglucerase alfa wera profil farmakokinetiku kważi lineari (jiġifieri l-ewwel ordni), u s-Cmax u AUC żdiedu kważi proporzjonalment mad-doża tul il-medda tad-doża 15 sa 60 unità/kg.
English: Only 1 out of 163 patients assessed developed anti-velaglucerase alfa antibodies during the study.
Maltese: Pazjent 1 biss minn 163 pazjent li ġew evalwati żviluppa antikorpi anti-velaglucerase alfa matul l-istudju.
English: Information is presented by system organ class and frequency according to MedDRA convention.
Maltese: L-informazzjoni hija ppreżentata skont il-klassi tal-organi tas-sistema tal-ġisem u skont ilfrekwenza skont il-konvenzjoni MedDRA.
English: Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies.
Maltese: Reazzjonijiet relatati mal-infużjoni (IRR) kienu l-aktar reazzjonijiet avversi komuni osservati fil-pazjenti ttrattati fi studji kliniċi.
English: In Studies 025EXT and 034, patients were offered home therapy.
Maltese: Fi Studji 025EXT u 034, il-pazjenti ġew offruti terapija d-dar.
English: Study 058 was an open-label clinical safety study in 211 patients including 205 patients previously treated with imiglucerase 6 treatment-naïve patients and 57 patients aged 65 years or older (56/57 had switched from imiglucerase to velaglucerase alfa).
Maltese: L-Istudju 058 kien studju bil-mediċina magħrufa dwar is-sigurtà klinika f'211-il pazjent inkluż 205 pazjenti li qabel ġew ittrattati b'imiglucerase u 6 pazjenti li qatt ma ħadu l-kura u 57 pazjent ta' 65 sena jew aktar (56/57 qelbu minn imiglucerase għal velaglucerase alfa).
English: ** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
Maltese: HT-1080 b'teknoloġija rikombinanti tad-DNA.
English: Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
Maltese: Kull kunjett ikun fih volum li jittieħed ta' 4.0 ml (100 unità/ml).
English: The safety and efficacy profiles were similar between paediatric and adult patients.
Maltese: Il-profili tas-sigurtà u l-effikaċja kienu simili bejn pazjenti pedjatriċi u adulti.
English: Meaningful increases from baseline were observed in the 45 Units/kg dose group in haemoglobin concentration (+2.4 g/dl) and platelet count (+40.9 x 10
Maltese: Ġew osservati żidiet sinifikanti mil-linja bażi fil-grupp tad-doża ta' 45 unità/kg fil-konċentrazzjoni tal-emoglobina (+2.4 g/dl) u lgħadd ta' plejtlits (+40.9 x 10
English: To be administered as a 60-minute intravenous infusion.
Maltese: Għandha tingħata bħala infużjoni ta' 60 minuta ġol-vini.
English: Store in a refrigerator (2C - 8C).
Maltese: Aħżen fi friġġ (2C - 8C)
English: The range of velaglucerase alfa clearance in paediatric patients (N=7, age range 4 to 17 years) was contained within the range of clearance values in adult patients (N=15, age range 19 to 62 years).
Maltese: Il-medda ta' eliminazzjoni ta' velaglucerase alfa fil-pazjenti pedjatriċi (N=7, firxa ta' età minn 4 sa 17-il sena) inżammet fi ħdan il-limitu tal-valuri ta' eliminazzjoni f'pazjenti adulti (N=15, medda ta' età minn 19 sa 62 sena).
English: The steady state volume of distribution was approximately 10% of the body weight.
Maltese: Il-volum ta' distribuzzjoni fi stat stabbli kien bejn wieħed u ieħor 10% tal-piż tal-ġisem.
English: Date of first authorisation: 26 August 2010 Date of latest renewal: 19 June 2015
Maltese: Data tal-aħħar tiġdid: 19 Ġunju, 2015
English: Each 400 Units vial is reconstituted with 4.3 ml of sterile water for injections.
Maltese: Kull kunjett ta' 400 unità jiġi rikostitwit ma' 4.3 ml ta' ilma sterili għall-injezzjonijiet.
English: In studies with VPRIV additional side effects have also been reported:
Maltese: Fi studji b'VPRIV ġew irrappurtati effetti sekondarji addizzjonali wkoll:
English: Mix gently.
Maltese: Tħawwadx.
English: Each 400 Units vial of this medicine contains 12.15 mg sodium.
Maltese: Kull kunjett ta' 400 unità ta' din il-mediċina fih 12.15 mg sodium.
English: After a minimum of 12 months of continuous treatment with velaglucerase alfa, all patients qualified to have the dose of velaglucerase alfa reduced in a step-wise fashion from 60 to 30 Units/kg after achieving at least 2 of the 4 “Year 1” therapeutic goals of ERT for type 1 Gaucher disease.
Maltese: Wara minimu ta' 12-il xahar ta' trattament kontinwu b'velaglucerase alfa, il-pazjenti kollha kkwalifikaw sabiex ikollhom id-doża ta' velaglucerase alfa mnaqqsa b'mod gradwali minn 60 sa 30 unità/kg wara li kisbu mill-inqas 2 mill-4 miri terapewtiċi tal“1 Sena” ta' ERT għat-tip 1 tal-marda ta' Gaucher.
English: Investigations activated partial thromboplastin time prolonged, neutralizing antibody positive
Maltese: Investigazzjonijiet thromboplastin parzjali fuq tul ta' żmien attivata, innewtralizzar tal-antikorp f'pożittiv
English: This medicinal product contains 12.15 mg sodium per vial.
Maltese: Kunjett wieħed fih 12.15 mg ta' sodium.
English: 20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap.
Maltese: Kunjett ta' 20 ml (ħġieġ tat-tip I) b'tapp (butyl rubber miksi bil-fluoro-resin), siġill f'biċċa waħda, u għatu flip-off.