FrancophonIA/ELRC3.0 huggingface dataset:
English: This increased risk of acute stent thrombosis was observed during the first 4 hours following the end of the procedure among patients who either discontinued the infusion of bivalirudin at the end of the procedure or received a continued infusion at the reduced dose of 0.25 mg/kg/h (see section 4.2).
Maltese: Dan ir-riskju miżjud ta' trombożi akuta tal-istent ġie osservat matul l-ewwel 4 sigħat wara t-tmiem tal-proċedura fost pazjenti li, jew waqqfu l-infużjoni ta' bivalirudin fit-tmiem tal-proċedura jew li rċevew infużjoni kontinwata bid-doża mnaqqsa ta' 0.25 mg/kg/h (ara sezzjoni 4.2).
English: Pericardial haemorrhage,
Maltese: koagulazzjoni irriversibbli
English: *Superiority p-value.
Maltese: * valur-p ta' superjorita'.
English: Renal Insufficiency
Maltese: GĦAMLA KWALITATTIVA
English: In the HORIZONS study both major and minor bleeding occurred commonly (1/100 and <1/10).
Maltese: Fl-istudju Horizons kemm fsad maġġuri u fsad minuri kienu komuni (1/100 u <1/10).
English: In healthy volunteers and patients, bivalirudin exhibits dose- and concentration-dependent anticoagulant activity as evidenced as prolongation of the ACT, aPTT, PT, INR and TT. Intravenous administration of bivalirudin produces measurable anticoagulation within minutes.
Maltese: F'voluntiera u pazjenti b'saħħithom, bivalirudin juri attività antikoagulanti dipendenti fuq id-doża u lkonċentrazzjoni kif jidher mit-titwil ta' l-ACT, l-aPTT, il-PT, l-INR u TT.
English: Reconstituted solution: Store in a refrigerator (2 - 8
Maltese: Aħżen fi friġġ (2 - 8
English: Co-administration with platelet inhibitors or anti-coagulants
Maltese: Plejtlits, fsada u koagulazzjoni
English: Elderly
Maltese: ACUITY
English: Renal and urinary disorders
Maltese: Disturbi fil-kliewi u fis-sistema urinarja ematurija
English: Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at oC. Store in a refrigerator (2
Maltese: Stabilità kimika u fiżika waqt l-użu ġiet murija għal 24 siegħa f'temperatura ta'
English: Unplanned revasc.
Maltese: Intenzjoni li titratta
English: The primary metabolite resulting from the cleavage of Arg3-Pro4 bond of the Nterminal sequence by thrombin is not active because of the loss of affinity to the catalytic active site of thrombin.
Maltese: Il-metabolit primarju li jirriżulta mill-qasma tar-rabta Arg3-Pro4 tas-sekwenza N-terminali mit-thrombin mhuwiex attiv minħabba t-telf ta' l-affinità għas-sit katalittiku attiv tat-thrombin.
English: Patients must be observed carefully for symptoms and signs of bleeding during treatment particularly if bivalirudin is combined with another anticoagulant (see section 4.5).
Maltese: Il-pazjenti jridu jiġu osservati b'attenzjoni għal sintomi u sinjali ta' fsada waqt it-trattament b'mod partikolari jekk bivalirudin huwa kkombinat ma' antikoagulant ieħor (ara sezzjoni 4.5).
English: C - A Risk diff. (95% CI)
Maltese: (95% CI)
English: All the undesirable effects, primary and secondary, resulting from excessive pharmacological activity were reversible.
Maltese: L-effetti mhux mixtieqa kollha, primarji u sekondarji, li rriżultaw minn attività farmakoloġika eċċessiva kienu riversibbli.
English: The infusion of 1.75 mg/kg body weight/hour may be continued for up to 4 hours post-PCI and at a reduced dose of 0.25 mg/kg body weight/hour for an additional 4 - 12 hours as clinically necessary.
Maltese: L-infużjoni ta' 1.75 mg/kg piż talġisem/siegħa tista' titkompla għal massimu ta' 4 sigħat wara PCI u b'doża mnaqqsa ta' 0.25 mg/kg piż tal-ġisem/siegħa għal 4 - 12-il siegħa addizzjonali skont dak li jkun hemm bżonn klinikament.
English: Major bleeding in the HORIZONS study was also defined using the ACUITY scale.
Maltese: Fsad maġġuri fl-istudju HORIZONS kien definit ukoll billi ntuża l-iskala ACUITY.
English: For patients undergoing PCI, an additional intravenous bolus of 0.5 mg/kg bivalirudin was administered and the rate of intravenous infusion increased to 1.75 mg/kg/h.
Maltese: Pazjenti li kienu qegħdin jagħmlu PCI, ingħataw bolus ġol-vina addizzjonali ta' 0.5 mg/kg ta' bivalirudin u r-rata ta' infużjoni ġol-vina żdiedet għal 1.75 mg/kg/h.
English: Κύπρος THESPIS PHARMACEUTICAL LtdΤηλ: Τηλ:
Maltese: Angiox jintuża biex jittratta pazjenti:
English: However, the maximal ACT values for all groups (adults and all paediatric groups) converge at a similar level near an ACT of 400 seconds.
Maltese: Madankollu, il-valuri massimi ta' ACT għall-ġruppi kollha (adulti u l-gruppi pedjatriċi kollha) jiltaqgħu f'livell simili qrib ACT ta' 400 sekonda.
English: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Denmark
Maltese: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Id-Danimarka
English: Member State (in EEA)
Maltese: Membru UE/ŻEE
English: Acipimox Olbetam 250 mg kemény kapszula
Maltese: Olbetam 250 mg kemény kapszula
English: Denmark
Maltese: IdDanimarka
English: via Isonzo, 71 04100 Latina Italy
Maltese: Pfizer Italia S.r.l. via Isonzo, 71 04100 Latina L-Italja
English: Sandwich, Kent CT13 9NJ United Kingdom
Maltese: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Ir-Renju Unit
English: Italy
Maltese: Stat
English: Acipimox Olbetam 250 mg Capsules 250 mg capsule
Maltese: Olbetam 250 mg Capsules
English: Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Vienna
Maltese: L-Awstrija Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1
English: Belgium PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
Maltese: Il-Belġju PFIZER S.A. Boulevard de la Plaine 17 1050
English: 1123 Budapest
Maltese: 1210 Vienna
English: Pfizer Gyógyszerkereskedelmi Kft. Alkotás St 53
Maltese: L-Ungerija Pfizer Gyógyszerkereskedelmi
English: Pfizer Italia S.r.l.
Maltese: PFIZER S.A.
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn għandhom jingħataw, detenturi tal-awtorizzazzjoni għat-tqegħid fis suq fl-istati membri
English: 2909 LD, Capelle a/d Ijssel The Netherlands
Maltese: Westlaan 142 2909 LD,
English: The Netherlands Pfizer B.V. Rivium Westlaan 142
Maltese: Pfizer B.V.
English: Acipimox Olbetam - Kapseln
Maltese: Olbetam - Kapseln 250 mg
English: Marketing authorisaton holder INN Invented name
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq
English: Atlantic salmon (Salmo salar)
Maltese: Atlantiku (Salmo salar)
English: Bag (ethyl vinyl acetate)
Maltese: Borża (ethyl vinyl acetate)
English: 1 bag
Maltese: 1 borża
English: EU (MA) number Invented name
Maltese: Numru ta' l-UE (MA)
English: Packaging Content Package size
Maltese: Daqs talpakkett
English: MA 01701 United States
Maltese: MA 01701 Stati
English: ATC code: A16AB04.
Maltese: A16AB04.
English: Genzyme Corporation 45, 51, 68, 74, 76 and 80 New York Avenue Framingham
Maltese: Genzyme Corporation 45, 51, 68, 74, 76 and 80
English: Antibody status should be regularly monitored.
Maltese: L-istat ta' l-antikorpi għandu jiġi monitorat regolarment.
English: Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Maltese: Genzyme Europe B.V. Paasheuvelweg 25 1105 BP Amsterdam L-Olanda
English: Use Aseptic Technique
Maltese: Uża Teknika Asettika
English: Package sizes: 1, 5 and 10 vials per carton.
Maltese: Qisien tal-pakketti: 1, 5 u 10 kunjetti kull kartuna.
English: 1105 BP Amsterdam The Netherlands
Maltese: BP Amsterdam, L-Olanda
English: • syncope
Maltese: • sinkope
English: Eye disorders --
Maltese: Disturbi vaskulari --
English: There is a theoretical risk of decreased agalsidase beta activity.
Maltese: Hemm riskju teoretiku ta' tnaqqis fl-attività ta' agalsidase beta.
English: • bronchospasm
Maltese: • bronkospażmu
English: Vss ranged from 8.3-40.8 l, plasma clearance from 119-345 ml/min and the mean elimination half-life from 80-120 minutes.
Maltese: Il-Vss varja bejn 8.3-40.8 1/kg, it-tneħħijja mil-plażma kienet bejn 119-345 ml/min u l-half-life ta' l-eliminazzjoni medja kienet bejn 80-120 minuta.
English: Agalsidase beta is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Maltese: Agalsidase beta hi proteina u hi mistennija li tkun degradata metabolikament permezz ta' l-idrolisi tal-peptidi.
English: The rate of clinical events was substantially lower among Fabrazyme-treated patients compared to placebo-treated patients (risk reduction = 53% intent-to-treat population (p=0.0577); risk reduction = 61 % per-protocol population (p=0.0341)).
Maltese: (p=0.0577); tnaqqis fir-riskju = 61% skont popolazzjoni ta' protokoll (p=0.0341)).
English: Incidence of adverse reactions with Fabrazyme treatment System organ class
Maltese: Inċidenza ta' reazzjonijiet avversi bi trattament b'Fabrazyme Sistema tal-klassifika ta' l-organi
English: • oedema
Maltese: • edema
English: Adverse reactions reported from clinical trials with a total of 168 patients (154 males and 14 females) treated with Fabrazyme administered at a dose of 1 mg/kg every 2 weeks for a minimum of one infusion up to a maximum of 5 years are listed by System Organ Class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10 and uncommon ≥ 1/1000 to < 1/100) in the table below.
Maltese: Reazzjonijiet avversi rapportati minn provi b'total ta' 168 pazjent (154 raġel u 14-il mara) ittrattati b'Fabrazyne li ngħataw doża ta' 1 mg/kg kull ġimagħtejn għal minimu ta' infużjoni waħda sa massimu ta' 5 snin huma elenkati skont is-Sistema tal-Klassifika ta' l-Organi u frekwenza (komuni ħafna ≥1/10; komuni ≥ 1/100 sa < 1/10 u mhux komuni ≥1/1000 sa <1/100) fit-tabella t'hawn taħt.
English: It is characterised by the deficiency of α-galactosidase.
Maltese: Hija karatterizzata minn nuqqas ta' l-α-galactosidase.
English: Plasma GL-3 levels rapidly normalised with treatment and remained normal through 5 years.
Maltese: Livelli ta' GL-3 fil-plażma innormalizzaw malajr bi trattament u baqgħu normali matul il- 5 snin.
English: The elimination half-life was dose independent and ranged from 45 to 100 minutes.
Maltese: Il-half-life ta' l-eliminazzjoni kienet indipendenti mid-doża u kienet mifruxa fuq medda ta' bejn 45 u 100 minuta.
English: For doses lower than 35 mg use a minimum of 50 ml, for doses 35 to 70 mg use a minimum of 100 ml, for doses 70 to 100 mg use a minimum of 250 ml and for doses greater than 100 mg use only 500 ml.
Maltese: 35 mg uża minimu ta' 50 ml, għal dożi ta' 35 sa 70 mg uża minimu ta' 100 ml, għal dożi ta' 70 mg sa 100 mg uża minimu ta' 250 mg u għal dożi akbar minn 100 mg uża biss 500 ml.
English: Cardiac Disorders tachycardia, palpitations, bradycardia sinus bradycardia --
Maltese: takikardja, palpitazzjonijiet, bradikardja sinus bradikarja
English: Sustained clearance of GL-3 from kidney vascular endothelium upon agalsidase beta treatment was demonstrated further in the open label extension of this trial.
Maltese: Tneħħija sostnuta ta' GL-3 mill-endotelju vaskulari tal-kliewi bi trattament b'agalsidase beta kien appoġġjat aktar fl-estensjoni open label ta' din il-prova.
English: After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta.
Maltese: Wara r-rikostituzzjoni b'7.2 ml ta' ilma għall-injezzjonijiet, kull kunjett ta' Fabrazyme ikun fih 5 mg/ml (35 mg/7 ml) ta' agalsidase beta.
English: The infusion-associated reactions were managed by a reduction in the infusion rate together with the administration of non-steroidal anti-inflammatory medicinal products, antihistamines and/or corticosteroids.
Maltese: Reazzjonijiet assoċjati ma' l-infużjoni kienu mmaniġġati bi tnaqqis fir-rata ta' l-infużjoni flimkien ma' l-għoti ta' prodotti mediċinali anti-infjammatorji mhux sterojdi, antistamini u/jew kortikosterojdi.
English: Additional symptoms included mild or moderate dyspnoea, hypoxia (oxygen saturation decreased), throat tightness, chest discomfort, flushing, pruritus, urticaria, face oedema, angioneurotic oedema, rhinitis, bronchospasm, tachypnoea, wheezing, hypertension, hypotension, tachycardia, palpitations, abdominal pain, nausea, vomiting, infusion-related pain including pain at the extremities, myalgia, and headache.
Maltese: Sintomi addizzjonali kienu jinkludu dispnea ħafifa jew moderata, ipoksja (saturazzjoni tal-ossiġenu mnaqqsa), griżmejn issikkati, skonfort fis-sider, fwawar, ħakk, urtikarja, edema tal-wiċċ, edema anġjonewrotika, rinite, bronkospażmu, takipneja, tħarħir, pressjoni għolja, pressjoni baxxa, takikardja, palpitazzjonijiet, uġigħ addominali, nawsja, rimettar, uġigħ relatat ma' l-infużjoni li jinkludi uġigħ fl-estremitajiet, uġigħ fl-għadam u uġigħ ta' ras.
English: In the dose finding study, the effects of 0.3, 1.0 and 3.0 mg/kg once every 2 weeks and 1.0 and 3.0 mg/kg once every 2 days were evaluated.
Maltese: Fl-istudju dwar id-dożi l-effetti ta' 0.3, 1.0 u 3.0 mg/kg darba kull ġimagħtejn u 1.0 u 3.0 mg/kg darba kull jumejn kienu evalwati.
English: Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
Maltese: Fabrazyme hu indikat f'persuni adulti, tfal u adolexxenti li għandhom 8 snin jew iżjed.
English: It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles which will not lead to any loss of agalsidase beta activity.
Maltese: Huwa rakkomandat li s-soluzzjoni dilwita tingħata permezz ta' pajp low-protein binding b'filter ta' 0.2 µm sabiex jitneħħew il-partiċelli tal-proteini li ma jwasslux għal xi telf fl-attività ta' agalsidase beta.
English: Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006
Maltese: Data tal-aħħar tiġdid: 03 ta' Awwissu, 2006
English: No clinical studies have been performed in children 0-4 years old.
Maltese: Ma saru ebda studji kliniċi fi tfal bejn 0-4 snin.
English: • upper respiratory tract congestion
Maltese: • konġestjoni fl-apparat respiratorju ta' fuq
English: Baseline CL was 77 ml/min with a Vss of 2.6 l; half-life was 55 min. After IgG seroconversion, CL decreased to 35 ml/min, Vss increased to 5.4 l, and half-life increased to 240 min.
Maltese: Wara serokonverżjoni ta' IgG, is-CL tnaqqset għal 35 ml/min, Vss żdied għal 5.4 l u l-half-life żdied għal 240 min.
English: This was achieved in 47 of the 49 patients (96%) with available information at month 6, and in 8 of the 8 patients (100%) with available information at the end of the study (up to a total of 5 years of treatment).
Maltese: Dan intlaħaq f'47 mid-49 pazjent (96%) b'informazzjoni disponibbli fis-6 xahar, u fi 8 mit-8 pazjenti (100%) b'informazzjoni disponibbli fl-aħħar ta' l-istudju (sa total ta' 5 snin ta'
English: Superficial skin capillary endothelium GL-3 scores were reduced to zero or maintained at zero at all time points post-baseline upon treatment in 19/27 patients completing the study without a dose increase.
Maltese: Ilpunteġġi GL-3 tal-endotiljum kapillari tas-superfiċje tal-ġilda tnaqqsu għal zero jew inżammu f'zero f'kull punt tal-ħin wara l-linja bażi waqt it-trattament f'19/27 pazjent li komplew l-istudju mingħajr żieda fid-doża.
English: Determine the total volume of sodium chloride 0.9% solution for infusion (between 50 and 500 ml) based on the individual dose.
Maltese: Iddetermina l-volum totali ta' 0.9% soluzzjoni għall-infużjoni ta' sodium chloride (bejn 50 u 500 ml) skont id-doża individwali.
English: Other medicines and Fabrazyme
Maltese: Mediċini oħra u Fabrazyme
English: EU/1/01/188/001 Fabrazyme 35 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 Fabrazyme 35 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 Fabrazyme 35 mg 10 vials of powder for concentrate for solution for infusion EU/1/01/188/004 Fabrazyme 5 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 Fabrazyme 5 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 Fabrazyme 5 mg 10 vials of powder for concentrate for solution for infusion
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/188/004 kunjett 1 ta' trab għall-konċentrat għal soluzzjoni għall-infużjoni EU/1/01/188/005 5 kunjetti ta' trab għall-konċentrat għal soluzzjoni għall-infużjoni EU/1/01/188/006 10 kunjetti ta' trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: The net effect of these changes after seroconversion was an increase in exposure of 2- to 3-fold based on AUC and Cmax.
Maltese: L-effett nett ta' dawn ilbidliet wara serokonverżjoni kien żieda ta' 2 sa 3 darbiet fl-espożizzjoni skont l-AUC u Cmax.
English: After IgG seroconversion, there was no apparent change in CL (+24% and +6%, resp.), while Vss was 1.8 and 2.2 fold higher, with the net effect being a small decrease in Cmax (up to -34% and -11%, resp.) and no change in AUC (-19% and6%, resp.).
Maltese: Wara serokonverżjoni ta' IgG, deher li ma kien hemm ebda bidla fis-CL (+24% u +6%, risp.), waqt li l-Vss kien 1.8 u 2.2-il darba ogħla, b'effett nett ikun tnaqqis żgħir fis-Cmax (sa -34% u -11%,
English: In another study with 30 paediatric patients with available pharmacokinetics data, aged 5 to 18 years, treated with two lower dose regimens of 0.5 mg/kg every 2 weeks and 1.0 mg/kg every 4 weeks, mean CL was 4.6 and 2.3 ml/min/kg, respectively, mean Vss was 0.27 and 0.22 l/kg, respectively, and mean elimination half-life was 88 and 107 minutes, respectively.
Maltese: 4 ġimgħat, medja CL ta' 4.6 u 2.3 ml/min/kg, rispettivament, medja Vss kienet ta' 0.27 u 0.22 l/kg, rispettivament, u l-medja tal-half-life tal-eliminazzjoni kienet ta' 88 u 107 minuti, rispettivament.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel l amministrazzjoni, ara sezzjoni 6.6.
English: • nasopharyngitis
Maltese: • nasofarinġite
English: Infections and infestations nasopharyngitis rhinitis
Maltese: Disturbi fis-sistema immuni reazzjoni anafilattojdi
English: Sanofi S.p.A. Tel: +39 02 39394275
Maltese: Tel: +39 02 39394275
English: Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva li tista' tikkawża l-mewt (reazzjoni anafilattika) għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: - The training to be provided to the patient and /or caregiver should address the following elements: - That it is essential to follow strictly the prescribed dose and infusion rate - Method of preparation and administration of Fabrazyme - Instructions in handling possible adverse events - Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion - The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy - The need to keep a diary to document each treatment received at home and to bring it at each visit - It is the responsibility of the prescribing physician to verify that all necessary skills have been acquired by the non-healthcare professional and that Fabrazyme may be safely and effectively administered at home.
Maltese: - Li hi r-responsabbiltà tat-tabib li jkun qed jagħti r-riċetta li jipprovdi taħriġ adattat lill persuna li mhix professjonista fil-qasam tal-kura tas-saħħa, bħal pazjent għall-għoti lilu nnifsu jew persuna li tkun qed tieħu ħsiebu li tkun se tagħti l-kura d-dar, jekk it-tabib li jkun qed jikkura lill-pazjent jiddeċiedi li dan hu adattat.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Maltese: Prodotti oħrajn tal-apparat alimentari u tal-metaboliżmu, enżimi.
English: Patients with antibodies to r-hαGAL have a greater potential to experience infusion-associated reactions (IARs).
Maltese: Pazjenti b'antikorpi għal r-hαGAL għandhom potenzjal akbar li jkollhom reazzjonijiet assoċjati mal-infużjoni (IARs).
English: Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta
Maltese: Fabrazyme 35 mg, trab għall-konċentrat għal soluzzjoni għall-infużjoni agalsidase beta
English: Patients experiencing mild or moderate infusion-associated reactions when treated with agalsidase beta during clinical trials have continued therapy after a reduction in the infusion rate (~0.15 mg/min; 10 mg/hr) and/or pre-treatment with antihistamines, paracetamol, ibuprofen and/or corticosteroids.
Maltese: 15 mg/min; 10 mg/siegħa) u/jew trattament minn qabel b'antistamini , paracetamol, ibuprofen u/jew kortikosterojdi.
English: Fabrazyme contains the active substance agalsidase beta and is used as enzyme replacement therapy in Fabry disease, where the level of α-galactosidase enzyme activity is absent or lower than normal.
Maltese: Fabrazyme fih is-sustanza attiva agalsidase beta u jingħata bħala terapija ta' sostituzzjoni ta' enżimi fil-marda Fabry, meta l-livell ta' l-attività enżimatika ta' α-galactosidase hija nieqsa jew inqas min-normal.
English: • tinnitus
Maltese: • tinnite
English: Skin and subcutaneous tissue disorders pruritus, urticaria, rash, erythema, pruritus generalized, angioneurotic oedema, swelling face, rash maculo-papular livedo reticularis, rash erythematous, rash pruritic, skin discolouration, skin discomfort leukocytoclastic vasculitis
Maltese: taħt il-ġilda ħakk, urtikarja, raxx, eritema, ħakk ġeneralizzat, edema anġjonewrotika, wiċċ minfuħ, raxx makulo papulari livedo reticularis, raxx eritematosi,
English: The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase A.
Maltese: Ċiniż (CHO). Is-sekwenza ta' l-aċidi aminiċi tal-forma rikombinanti, flimkien mas-sekwenza tan-nukleotidi li tiddeċifrha, huma identiċi għall-forma naturali ta' l-α-galactosidase A.
English: - The active substance is agalsidase beta, one vial contains 35 mg. - The other ingredients are:
Maltese: - Is-sustanza attiva hi agalsidase beta, kunjett wieħed fih 35 mg.
English: • urticaria
Maltese: Pożoloġija
English: Then slowly inject the reconstituted solution directly into the 0.9% sodium chloride intravenous solution (not in any remaining airspace) to a final concentration between 0.05 mg/ml and 0.7 mg/ml.
Maltese: Imbagħad injetta bil-mod is-soluzzjoni rikostitwita fis-soluzzjoni intravenuża ta' 0.9% sodium chloride (mhux f'xi wiċċ li fadal ta' arja) għal konċentrazzjoni finali ta' bejn 0.05 mg/ml u 0.7 mg/ml.
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħrufa (il-frekwenza ma tistax tkun stmata mid-data disponibbli):
English: • rhinitis
Maltese: • rinite
English: Adverse reactions only reported during the Post Marketing period are also included in the table below at a frequency category of “not known” (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġew rapportati biss waqt il-perijodu ta' Wara t-Tqegħid fis-Suq ġew inklużi wkoll fit-tabella t'hawn isfel fil-kategorija ta' frekwenzi ta' “mhux magħrufa” (ma tistax tittieħed stima mid-data disponibbli).
English: Studies have not been performed to examine the effects of Fabrazyme on fertility.
Maltese: Ma sarux studji biex jeżaminaw l-effetti ta' Fabrazyme fuq il fertilità.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad