FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical efficacy of Esperoct for prophylaxis and treatment of bleeds was investigated in five prospective, multi-centre clinical studies in 270 previously treated patients (PTPs) with severe haemophilia A.
Maltese: L-effikaċja klinika ta' Esperoct fil-prevenzjoni u t-trattament ta' fsada kienet investigata f'ħames studji kliniċi prospettivi u multiċentriċi f'pazjenti li kienu diġà ttrattati qabel (PTPs) għal emofilja A severa.
English: Rash Erythema Pruritus
Maltese: Reazzjonijiet allerġiċi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 10.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Maltese: Il-kumpless magħmul minn fattur VIII/fattur von Willebrand jikkonsisti f'żewġ molekuli (ilfattur VIII u l-fattur von Willebrand) b'funzjonijiet fiżjoloġiċi differenti.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Reazzjonijiet ta' sensittività eċċessiva jew allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit tal-infużjoni, tkexkix ta' bard, fwawar, urtikarja mifruxa, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, nawsja, irrekwitezza, takikardija, tagħfis fis-sider, tingiż, rimettar, tħarħir) ġew osservati b'mod rari u jistgħu f'xi każijiet jiżviluppaw f'anafilassi qawwija (inkuż xokk).
English: For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-ħażna f'temperatura tal-kamra u kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Esperoct 3000 IU powder and solvent for solution for injection Each powder vial contains nominally 3000 IU turoctocog alfa pegol*.
Maltese: Esperoct 3000 UI trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett tat-trab fih nominalment 3000 UI ta' turoctocog alfa pegol*.
English: Factor VIII is a protein found in the blood that helps to prevent and stop bleeding.
Maltese: Il-fattur VIII huwa proteina li tinstab fid-demm li tgħin tippreveni u twaqqaf il-fsada.
English: Table 4 Single-dose pharmacokinetic parameters of Esperoct 50 IU/kg in children, adolescents and adults by age using the chromogenic assay (geometric mean [CV%])
Maltese: UI/kg fit-tfal, fl-adolexxenti u fl-adulti skont l-età bl-użu tal-assaġġ kromoġeniku (medja ġeometrika [CV%])
English: Novo Nordisk A/S Novo Allé
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Novo Nordisk A/S
English: The frequencies of adverse reactions as observed in 270 unique subjects across five prospective, multi-centre clinical studies in previously treated patients (PTPs) with severe haemophilia A (<1% endogenous factor VIII activity) and no history of inhibitors are listed in table 3.
Maltese: Il-frekwenzi tar-reazzjonijiet avversi osservati f'270 individwu minn ħames studji kliniċi prospettivi, multiċentriċi f'pazjenti ttrattati preċedentement (PTPs, previously treated patients) għal emofilja A qawwija (<1% attività ta' fattur VIII endoġenu) u b'ebda storja medika ta' inibituri huma mniżżla fittabella 3. Il-kategoriji ta' reazzjonijiet avversi ppreżentati fit-tabella 3 huma skont is-sistema talklassifika tal-organi MedDRA (SOC - system organ classification u Livell ta' Terminu Preferut ).
English: Repeat every 8 to 24 hours to maintain factor VIII activity within the target range
Maltese: Irrepeti kull 8 sa 24 siegħa biex iżżomm l-attività talfattur VIII fil-marġni ta' mira ta' attività
English: • chest tightness
Maltese: • tħarħir
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Maltese: L-emofilja A hija disturb ereditarju ta' koagulazzjoni tad-demm marbut mas-sess tal-persuna fejn ikun hemm livelli mnaqqsa ta' fattur VIII:C u twassal għal fsada kbira fil-ġogi, fil-muskoli, jew fl-organi interni, li tista' tkun jew b'mod spontanju jew minħabba trawma aċċidentali jew kirurġika.
English: Powder: 500 IU turoctocog alfa pegol (approx. 125 IU/mL after reconstitution),
Maltese: UI turoctocog alfa pegol (madwar 125 UI/mL wara r-rikostituzzjoni),
English: Esperoct 3000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Maltese: IL-PRODOTT MEDIĊINALI Esperoct 3000 UI trab u solvent għal soluzzjoni għall-injezzjoni turoctocog alfa Pegol (fattur VIII rikombinanti ta' koagulazzjoni)
English: Factor VIII inhibition Uncommon (PTPs)**
Maltese: Reazzjonijiet fis-sit talinjezzjoni***
English: Powder: 1500 IU turoctocog alfa pegol (approx. 375 IU/mL after reconstitution),
Maltese: UI turoctocog alfa pegol (madwar 375 UI/mL wara r-rikostituzzjoni),
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Maltese: F'pazjenti li diġà għandhom fatturi ta' riskju kardjovaskulari, terapija ta' sostituzzjoni b'fattur VIII tista' żżid ir-riskju kardjovaskulari.
English: Single-dose pharmacokinetic parameters of Esperoct are listed in table 4.
Maltese: Il-parametri farmakokinetiċi wara doża waħda ta' Esperoct huma mniżżla f'tabella 4.
English: For treatment of bleeds a maximum single dose of Esperoct at 75 IU/kg and a maximum total dose of 200 IU/kg/24 hours may be administered.
Maltese: Tista' tingħata doża waħda massima ta' Esperoct ta' 75 UI/kg u doża totali massima ta' 200
English: Each pack of Esperoct contains: - 1 glass vial (type I) with powder closed with a chlorobutyl rubber stopper, an aluminium seal with a plastic snap-off cap - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 mL solvent with backstop (polypropylene), a rubber plunger
Maltese: Kull pakkett ta' Esperoct fih: - kunjett wieħed tal-ħġieġ (tat-tip I) bi trab magħluq b'tapp tal-gomma tal-chlorobutyl, siġill tal aluminju b'għatu tal-plastik li jitqaċċat - adapter tal-kunjett wieħed sterili għar-rikostituzzjoni - siringa waħda mimlija għal-lest b'4 mL ta' solvent bi lqugħ fuq wara (polypropylene), planġer tal-gomma (bromobutyl) u tapp fit-tarf tal-gomma (bromobutyl) - lasta tal-planġer waħda (polypropylene).
English: a The required dose is determined using the following formula: Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Maltese: Unitajiet meħtieġa (UI) = il-piż tal-ġisem (kg) x kemm hu meħtieġ jogħla l-fattur VIII (%) (UI/dL) x 0.5
English: Clinical efficacy during prophylaxis and treatment of bleeding episodes
Maltese: Effikaċja klinika matul il-profilassi u t-trattament ta' episodji ta' fsada
English: 2000 IU
Maltese: UI, 2000
English: Minor surgery
Maltese: Operazzjoni minuri
English: Within one hour before surgery
Maltese: Immaniġġjar waqt kirurġija
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: • Use a clean and germ-free (aseptic) technique.
Maltese: • Uża teknika nadifa u mingħajr mikrobi (asettika).
English: In general, there was a trend of increasing incremental recovery and decreasing clearance (mL/h/kg) with age.
Maltese: B'mod ġenerali, kien hemm tendenza ta' żieda fl-irkupru inkrementali u tnaqqis fit-tneħħija (mL/siegħa/kg) mal-età.
English: Table 2 includes general recommendation for dosing of Esperoct for perioperative management.
Maltese: Tabella 2 tinkludi rakkomandazzjonijiet ġenerali għad-dożaġġ ta' Esperoct għall-immaniġġjar waqt kirurġija.
English: • Bring the vial and the pre-filled syringe to room temperature.
Maltese: • biċċiet ħoxnin tal-garża u stikk.
English: The efficacy and safety of Esperoct for prophylaxis treatment of bleeds were evaluated in an open-label, single-arm, non-controlled trial in 68 children below 12 years with severe haemophilia A. The prophylactic effect of Esperoct was demonstrated with a dosing at 60 IU per kg body weight (50-75 IU/kg) twice weekly.
Maltese: L-effikaċja u s-sigurtà ta' Esperoct għat-trattament ta' profilassi ta' fsada kienu evalwati fi prova open label, b'fergħa waħda, mhux ikkontrollata fi 68 tifel u tifla li kellhom età taħt it-12-il sena b'emofilja A severa.
English: Powder: 3000 IU turoctocog alfa pegol (approx. 750 IU/mL after reconstitution),
Maltese: UI turoctocog alfa pegol (madwar 750 UI/mL wara r-rikostituzzjoni),
English: To treat bleeding
Maltese: Tqala u treddigħ
English: By factor VIII replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Maltese: Permezz ta' terapija ta' sostituzzjoni tal-fattur VIII il-livelli talfattur VIII fil-plażma jiżdiedu, b'hekk issir possibbli korrezzjoni temporanja tad-defiċjenza fil-fattur u korrezzjoni tad-tendenzi tal-fsada.
English: What is in this leaflet
Maltese: Sa meta jkun hemm fejqan
English: Syringe cap
Maltese: Kemm għandek tuża
English: Table 2 Guidance for dosing of Esperoct for perioperative management Type of surgical procedure
Maltese: Tabella 2 Gwida għad-dożaġġ ta' Esperoct għall-immaniġġjar waqt kirurġija Tip ta' proċedura kirurġika
English: Injecting Esperoct via needleless connectors for intravenous (IV) catheters
Maltese: Meta tinjetta Esperoct permezz ta' konnetturi ta' mingħajr labra għal kateters fil-vina (IV)
English: The half-life of Esperoct was 1.6 fold longer compared to unmodified factor VIII products in adults.
Maltese: Fl-adulti, il-half-life ta' Esperoct kienet 1.6 darbiet itwal meta imqabbla ma' prodotti tal-fattur VIII
English: When including imputations, (replacing missing data for withdrawn patients with a substituted value) the estimated mean ABR for all bleeds was 3.70 (95% CI: 2.94;4.66).
Maltese: Meta tinkludi imputazzjonijiet (tissostitwixxi tagħrif nieqas minħabba pazjent li jkun ħareġ mill-istudju b'valur ieħor) l-istma medja ta' ABR għall-fsadi kollha kienet ta' 3.70 (95% CI: 2.94;4.66).
English: The efficacy of Esperoct for prophylaxis and treatment of bleeds was evaluated in an open-label, non-controlled trial in adolescents and adult patients with severe haemophilia A ages 12 years and above.
Maltese: L-effikaċja ta' Esperoct għall-profilassi u t-trattament ta' fsada kienet evalwata fi prova mhux ikkontrollata u open-label, f'pazjenti adolexxenti u adulti b'emofilja A severa b'etajiet minn 12-il sena 'l fuq.
English: Record the date when you store Esperoct at room temperature on the carton.
Maltese: Terġax tpoġġi Esperoct fil-friġġ wara li tkun ħżintu f'temperatura tal-kamra.
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota li r-rata annwali ta' fsada (ABR) ma tistax tiġi mqabbla bejn konċentrati differenti ta' fattur u bejn studji kliniċi differenti.
English: If you have previously received more than 150 days of treatment with factor VIII, inhibitors (antibodies) may develop (may affect up to 1 in 100 people).
Maltese: Jekk fil-passat inti rċevejt iktar minn 150 jum ta' trattament b'fattur VIII, tista' tiżviluppa inibituri (antikorpi) (jista' jaffettwa sa persuna waħda minn kull 100).
English: The factor VIII activity of Esperoct can be measured using the conventional factor VIII assays, the chromogenic assay and the one-stage assay.
Maltese: L-attività tal-fattur VIII ta' Esperoct tista' titkejjel bl-użu tal-assaġġ konvenzjonali tal-fattur VIII, lassaġġ kromoġeniku u l-assaġġ ta' stadju wieħed.
English: of patients
Maltese: KLINIKU
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Clinical efficacy of Esperoct in treatment of bleeding episodes and during on-demand treatment
Maltese: L-effikaċja klinika ta' Esperoct fit-trattament ta' episodji ta' fsada u waqt trattament fil-pront
English: Adults and adolescents (12 years of age and above): The recommended starting dose is 50 IU of Esperoct per kg body weight every 4 days.
Maltese: Adulti u adolexxenti (tfal minn età ta' 12-il sena u ikbar) Id-doża rrakkomandata tal-bidu hija ta' 50
English: • Injecting into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the reconstituted solution.
Maltese: • Meta tinjetta f'CVAD jista' jkollok bżonn tuża siringa sterili tal-plastik ta' 10 mL biex tiġbed is-soluzzjoni rrikostitwita.
English: Powder: 1000 IU turoctocog alfa pegol (approx. 250 IU/mL after reconstitution),
Maltese: UI ta' turoctocog alfa pegol (madwar 250
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Maltese: Ir-rilevanza klinika tal-iżvilupp ta' inibitur se tiddipendi fuq it-titru tal-inibitur, b'titru baxx ta' inibituri jimponi inqas riskju li jkun hemm rispons kliniku li ma jkunx suffiċjenti milli kieku jkun hemm titru għoli ta' inibituri.
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing is achieved
Maltese: Irrepeti l-injezzjoni kull 8 sa 24 siegħa kif meħtieġ sakemm ikun hemm fejqan adegwat tal ferita
English: Mild
Maltese: LOTT
English: • 1 vial adapter
Maltese: • adapter wieħed tal-kunjett
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Maltese: Dan huwa ta' importanza speċjalment meta tibdel illaboratorju u/jew ir-reaġenti użati fl-assaġġ.
English: Esperoct 3000 IU powder for solution for injection turoctocog alfa Pegol
Maltese: U MNEJN GĦANDU JINGĦATA Esperoct 3000 UI trab għal soluzzjoni għall-injezzjoni turoctocog alfa pegol
English: (bromobutyl) and a rubber tip cap (bromobutyl) - 1 plunger rod (polypropylene).
Maltese: Għatu tal-plastik Tapp tal-lastku (taħt l-għatu tal-plastik)
English: These early signs may include rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, or dizziness, headache, nausea and vomiting.
Maltese: Il-pazjenti għandhom jiġu mgħarrfa dwar lewwel sinjali ta' reazzjonijiet ta' sensittività eċċessiva inkluż ħorriqija, urtikarja mifruxa, tagħfis fissider, tħarħir, pressjoni baxxa u anafilassi.
English: Esperoct 2000 IU powder and solvent for solution for injection turoctocog alfa Pegol (recombinant coagulation factor VIII)
Maltese: UI trab u solvent għal soluzzjoni għall-injezzjoni turoctocog alfa Pegol (fattur VIII rikombinanti ta' koagulazzjoni)
English: • Remove the protective cap from the vial adapter.
Maltese: • Neħħi l-għatu protettiv mill-adapter tal-kunjett.
English: Attach the vial adapter • Remove the protective paper from the vial adapter.
Maltese: Ponta tal-adapter (taħt il-karta protettiva)
English: Esperoct 2000 IU powder for solution for injection turoctocog alfa Pegol
Maltese: UI trab għal soluzzjoni għall-injezzjoni turoctocog alfa pegol
English: Esperoct is for intravenous use.
Maltese: Esperoct huwa għall-użu minn ġol-vini.
English: Eleven patients developed transient low titre anti-PEG antibodies.
Maltese: Ħdax-il pazjent żviluppaw ammont tranżitorju żgħir ta' antikorpi kontra PEG.
English: Wide top end
Maltese: GĦALL-ĦRUĠ TAL
English: a Incremental recovery and factor VIII were assessed 30 min post-dosing for patients 12 years and above and 60 min post-dosing (first sample) for children below12 years.
Maltese: L-irkupru inkrementali u l-fattur VIII kienu evalwati 30 min wara d-dożaġġ għal pazjenti li kellhom 12-il sena u ikbar u 60 min wara d dożaġġ (l-ewwel kampjun) għal tfal li għandhom inqas minn 12-il sena.
English: Powder: 2000 IU turoctocog alfa pegol (approx. 500 IU/mL after reconstitution),
Maltese: UI turoctocog alfa pegol (madwar 500
English: • Check the reconstituted solution.
Maltese: • Iċċekkja s-soluzzjoni rrikostitwita.
English: If a central venous access device (CVAD) is required, the risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Maltese: Jekk ikun hemm bżonn ta' apparat li jagħti aċċess għall-vina ċentrali (CVAD, central venous access device), wieħed irid joqgħod attent għar-riskju ta' kumplikazzjonijiet marbuta ma' CVAD li jinkludu infezzjonijiet lokali, batterimja u trombożi fis-sit tal-kateter.
English: Powder
Maltese: MedDRA
English: Unopened vial
Maltese: Novo Allé
English: An infusion set (butterfly needle with tubing), sterile alcohol swabs, gauze pads and plasters will also be needed.
Maltese: Inti se jkollok bżonn ukoll sett tal-infużjoni (labra butterfly b'pajp irqiq), mselħiet sterili bl-alkoħol, biċċiet ħoxnin tal-garża u stikk.
English: Leave the plunger rod untouched in the carton.
Maltese: Ħalli l-lasta talplanġer bla ma tmissha fil-kartuna.
English: No correlation with adverse events could be established.
Maltese: Ma setgħetx tiġi stabbilita korrelazzjoni ma' avvenimenti avversi.
English: Esperoct 500 IU powder and solvent for solution for injection Esperoct 1000 IU powder and solvent for solution for injection Esperoct 1500 IU powder and solvent for solution for injection Esperoct 2000 IU powder and solvent for solution for injection Esperoct 3000 IU powder and solvent for solution for injection turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)) This medicine is subject to additional monitoring.
Maltese: UI trab u solvent għal soluzzjoni għall-injezzjoni Esperoct 3000 UI trab u solvent għal soluzzjoni għall-injezzjoni turoctocog alfa pegol (fattur VIII tal-koagulazzjoni tal-bniedem (rDNA) pegilat)
English: • skin reactions where the injection is given
Maltese: • reazzjonijiet fil-ġilda fejn tingħata l-injezzjoni
English: Esperoct is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Maltese: Jekk tieħu Esperoct aktar milli suppost Jekk tieħu aktar Esperoct milli suppost, kellem lit-tabib tiegħek immedjatament.
English: • Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Maltese: • Tkomplix tagħfas il-lasta tal-planġer u ħalliha tersaq lura waħedha waqt li ssoluzzjoni rrikostitwita timla s-siringa.
English: Plastic cap
Maltese: Lasta talplanġer
English: Esperoct 1000 IU powder for solution for injection turoctocog alfa Pegol
Maltese: UI trab għal soluzzjoni għall-injezzjoni turoctocog alfa Pegol
English: Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 mL solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Maltese: Il-pakkett fih: kunjett wieħed ta' trab, 4 mL ta' solvent f'siringa mimlija għal-lest, lasta tal-planġer waħda u adapter tal-kunjett wieħed
English: Anti-drug antibodies
Maltese: IL-PRODOTT MEDIĊINALI
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Maltese: Il-fattur VIII attivat jiffunzjona bħala kofattur għall-fattur IX attivat, li jaċċelera l-bidla tal-fattur X f'fattur X attivat.
English: Each pack of Esperoct contains a vial with white to off-white powder, a 4 mL pre-filled syringe with a clear colourless solvent, a plunger rod and a vial adapter.
Maltese: Kull pakkett ta' Esperoct fih kunjett bi trab abjad jew kemxejn isfar, siringa ta' 4 mL mimlija għal-lest b'soluzzjoni ċara u mingħajr kulur, lasta tal-planġer u adapter tal-kunjett.
English: In the case of major surgical interventions in particular, monitoring of the factor VIII substitution therapy by measurement of plasma factor VIII activity is necessary.
Maltese: B'mod partikolari f'każ ta' interventi kirurġiċi maġġuri, huwa meħtieġ monitoraġġ tat-terapija ta' sostituzzjoni tal-fattur VIII permezz tal-kejl tal-attività tal-fattur VIII fil-plażma.
English: Esperoct is given as an injection into a vein (intravenously), see “Instructions on how to use Esperoct” for more information.
Maltese: Esperoct jingħata bħala injezzjoni ġol-vina, ara “Struzzjonijiet dwar kif tuża Esperoct” għal aktar informazzjoni.
English: The summaries of opinion of the Committee for Orphan Medicinal Products for Carbaglu can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations (NAGS deficiency: 18 October 2000; isovaleric acidaemia: 7 November 2008; methylmalonic acidaemia: 7 November 2008; propionic acidaemia: 7 November 2008).
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designations (NAGS deficiency: 18 ta' Ottubru 2000; isovaleric acidaemia: 7 ta' Novembru 2008; methylmalonic acidaemia: 7 ta' Novembru 2008; propionic acidaemia: 7 ta' Novembru 2008).
English: The full EPAR for Carbaglu 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: • N-acetylglutamate synthase (NAGS) deficiency.
Maltese: • Disturbi fis-sintażi N-aċetilglutamat (NAGS).
English: Carbaglu carglumic acid
Maltese: Carbaglu aċidu karglumiku
English: This is a summary of the European public assessment report (EPAR) for Carbaglu.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Carbaglu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Carbaglu to Orphan Europe on 24 January 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Carbaglu lil Orphan Europe fl-24 ta' Jannar 2003.
English: Carbaglu is a medicine that contains the active substance carglumic acid.
Maltese: Carbaglu huwa mediċina li fiha s-sustanza attiva aċidu karglumiku (carglumic acid)
English: Carbaglu has been studied in 20 patients, 12 of whom had NAGS deficiency and were treated for an average of about three years.
Maltese: Carbaglu ġie studjat f'20 pazjent, fejn 12 minnhom kellhom id-disturb NAGS u kienu trattati għal medja ta' madwar tliet snin.
English: The company also presented information from the published literature on a further four patients treated with the active substance in Carbaglu.
Maltese: Il-kumpanija ppreżentat ukoll informazzjoni minn dokumentazzjoni pubblikata dwar erba' pazjenti oħra trattati bis-sustanza attiva Carbaglu.
English: Because the number of patients with these diseases is low, they are considered ‘rare' and Carbaglu was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates (see below).
Maltese: Minħabba li n-numru ta' pazjenti li għandhom dan il-mard huwa wieħed baxx, huma ġew ikkunsidrati bħala ‘rari', u Carbaglu ġie kklassifikata bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) f'diversi dati (ara aktar ‘l isfel).
English: In patients with isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia, Carbaglu also induced a decrease in ammonia levels in the blood, following an average of 5.5 days of treatment.
Maltese: Fil-pazjenti li kienu jbatu minn aċidemja isovalerika, aċidemja metilmalonika u aċidemja propjonika, Carbaglu kellu effett ukoll fit-tnaqqis ta' livelli ta' ammonja fid-demm, wara medja ta' 5.5 jien ta' kura.