FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness of Nobivac Piro has been studied in three laboratory studies in which dogs were vaccinated and then challenged (exposed to wild type Babesia).
Maltese: L-effikaċja ta' Nobivac Piro ġiet studjata fi tliet studji tal-laboratorju li fihom il-klieb tlaqqmu u mbagħad ġew esposti għal Babesia tat-tip selvaġġ.
English: Vaccination with Novibac Piro does not prevent infection, so a milder form of disease caused by B. canis can occur.
Maltese: It-tilqimiet b'Novibac Piro ma jipprevenux infezzjoni, u allura, bihom tista' sseħħ forma inqas gravi tal-marda kkawżata minn B. canis.
English: What is the risk associated with Nobivac Piro?
Maltese: X'inhu r-riskju assoċjat ma' Nobivac Piro?
English: Nobivac Piro is a vaccine.
Maltese: Nobivac Piro hu tilqima.
English: The effects of vaccination were compared with those of vaccination using a placebo (a dummy treatment).
Maltese: L-effetti tat-tilqima tqabblu ma' dawk tat-tilqima bl-użu ta' plaċebo (trattament finta).
English: After vaccination, painful swelling or hardened nodules occur commonly at the site of vaccination.
Maltese: It-tilqima fiha wkoll kompost magħruf bħala saponin li jistimulaha tipproduċi rispons aħjar.
English: The main measure of effectiveness was the proportion of the dogs that developed antibodies against B. canis and B. rossi two weeks after the second injection.
Maltese: Il-kejl ewlieni ta' l-effikaċja kien il-proporzjon ta' klieb li żviluppaw antikorpi kontra B. canis u B. rossi ġimagħtejn wara t-tieni injezzjoni.
English: This overview was last updated in 06-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'06-2018.
English: Cerdelga contains the active substance eliglustat.
Maltese: Cerdelga fih is-sustanza attiva eliglustat.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Further information on Cerdelga 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: Other information about Cerdelga
Maltese: Informazzjoni oħra dwar Cerdelga
English: Cerdelga received a marketing authorisation valid throughout the EU on 19 January 2015.
Maltese: Cerdelga ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Jannar 2015.
English: Cerdelga is available as capsules (84 mg) to be taken by mouth.
Maltese: Cerdelga jiġi bħala kapsuli (84 mg) li għandhom jittieħdu mill-ħalq.
English: Gaucher disease is rare, and Cerdelga was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 December 2007.
Maltese: Il-marda ta' Gaucher hija rari, u Cerdelga ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-4 ta' Diċembru 2007.
English: The most common serious side effect is fainting, in 8 out of every 1,000 patients.
Maltese: L- effett sekondarju serju l-aktar komuni huwa ħass ħażin, li kien immanifestat fi 8 minn kull 1,000 pazjent.
English: In a study of 40 previously untreated patients with type-1 Gaucher disease, patients taking Cerdelga had a 28% reduction in spleen size, compared with a 2% increase in those taking placebo (a dummy treatment) after 9 months of treatment.
Maltese: Fi studju li involva 40 pazjent li ma kinux ikkurati qabel għall-marda ta' Gaucher tat-tip 1, il-pazjenti li ħadu Cerdelga kellhom tnaqqis ta' 28% fid-daqs tal-milsa, wara 9 xhur ta' kura, meta mqabbel ma' żieda ta' 2% f'dawk li ħadu l-plaċebo (kura finta).
English: What are the risks associated with Cerdelga?
Maltese: X'inhuma r-riskji assoċjati ma' Cerdelga?
English: Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults.
Maltese: Cerdelga hija mediċina użata għal kura fit-tul ta' pazjenti adulti bil-marda ta' Gaucher tat-tip 1.
English: Another study looked at Cerdelga in 159 patients whose disease was well controlled by enzyme replacement therapy.
Maltese: Studju ieħor eżamina Cerdelga f'159 pazjent, li l-marda tagħhom kienet ikkontrollata sew bit-terapija ta' sostituzzjoni tal-enzimi.
English: As for all medicines, data on the use of Cerdelga are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Cerdelga hija ssorveljata kontinwament.
English: The active substance in Cerdelga, eliglustat, works by blocking the action of an enzyme involved in the production of the glucosylceramide fat.
Maltese: Is-sustanza attiva f'Cerdelga, l-eliglustat, taħdem billi twaqqaf l-azzjoni ta' enzima involuta filproduzzjoni tax-xaħam tal-glukosilċeramide.
English: This causes symptoms such as anaemia (low red blood cell counts), tiredness, easy bruising, an enlarged spleen and liver, and bone pain and fractures.
Maltese: Dan jikkawża sintomi bħal anemija (għadd baxx ta' ċelluli tad-demm ħomor), għeja, tbenġil malajr, milsa u fwied imkabbrin, u wġigħ fl-għadam u ksur tal-għadam.
English: For the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara lfuljett ta' tagħrif.
English: All patients switching from enzyme replacement should be regularly monitored for disease progression.
Maltese: Il-pazjenti kollha li jaqilbu mill-kura ta' sostituzzjoni tal-enzimi għandhom jiġu sorveljati regolarment biex tkun ivverifikata l-progressjoni tal-marda.
English: Because the build-up of this fat in organs like the spleen, liver and bones is responsible for the symptoms of type-1 Gaucher disease, reducing its production helps prevent its build-up, and thereby helps the affected organs to function better.
Maltese: Minħabba li l-akkumulazzjoni ta' dan ix-xaħam fl-organi bħal ma huma l-milsa, il-fwied u l-għadam hija responsabbli għas-sintomi tal-marda Gaucher tat-tip 1, it-tnaqqis tal-produzzjoni ta' dan ix-xaħam jgħin biex jipprevjeni l-akkumulazzjoni tiegħu, u b'hekk lorgani affettwati jkunu mgħejjuna biex jaħdmu aħjar.
English: What measures are being taken to ensure the safe and effective use of Cerdelga?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cerdelga?
English: Gaucher disease is a genetic condition, in which a fat called glucosylceramide (or glucocerebroside) builds up in the body, typically in the liver, spleen and bone.
Maltese: Il-marda ta' Gaucher hija kundizzjoni ġenetika, li timmanifesta ruħha f'xaħam imsejjaħ glukosilċeramide (jew glukoċerebroside) li jibda jakkumula fil-ġisem, tipikament fil-fwied, fil-milsa u flgħadam.
English: In this study, the disease remained stable in 85% of patients who switched to Cerdelga for a year and in 94% of patients who continued with enzyme replacement therapy.
Maltese: F'dan l-istudju, irriżulta li l-marda baqgħet stabbli f'85% tal-pazjenti li qalbu għal Cerdelga għal sena u f'94% tal-pazjenti li komplew b'terapija ta' sostituzzjoni tal-enzimi.
English: However, a minority of patients (about 15%) who were switched from enzyme replacement to Cerdelga, did not respond optimally after treatment for one year.
Maltese: Madankollu, minoranza ta' pazjenti (madwar 15%) li nbidlitilhom il-kura minn sostituzzjoni tal-enzimi għal Cerdelga, ma rrispondewx blaħjar mod wara sena jieħdu l-kura.
English: The company will also keep record of patients treated with Cerdelga to look at the long-term safety of the medicine.
Maltese: Il-kumpanija se żżomm ukoll rekord ta' pazjenti kkurati b'Cerdelga biex teżamina s-sigurtà fit-tul tal-mediċina.
English: Patients who took Cerdelga also showed an improvement of other signs of the disease such as a reduction in liver size and increased levels of haemoglobin (the protein in red blood cells that carries oxygen).
Maltese: Pazjenti li ħadu Cerdelga wrew ukoll sinjali oħra ta' titjib fejn jidħlu s-sinjali tal-marda bħal tnaqqis fid-daqs tal-fwied u livelli ogħla ta' emoglobina (ilproteina fiċ-ċelluli tad-demm ħomor li ġġorr l-ossiġnu).
English: For the full list of side effects reported for Cerdelga, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Cerdelga, ara l-fuljett ta' tagħrif.
English: The company that markets Cerdelga will provide doctors and patients with educational materials to ensure that only patients with type-1 Gaucher disease are treated with Cerdelga and that Cerdelga is not used in some patients with liver problems and together with other medicines which can significantly alter its blood levels.
Maltese: Il-kumpanija li tqiegħed Cerdelga fis-suq se tipprovdi lit-tobba u lill-pazjenti b'materjal edukattiv biex tiżgura li pazjenti bil-marda Gaucher tat-tip 1 biss jiġu kkurati b'Cerdelga u li Cerdelga ma jintużax f'xi pazjenti bi problemi tal-fwied u flimkien ma' mediċini oħra li jistgħu jbiddlu b'mod sinifikanti l-livelli tad-demm.
English: Side effects reported with Cerdelga are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Cerdelga huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Studies show that Cerdelga is effective at treating the disease, including reducing the size of enlarged spleens and livers.
Maltese: L-istudji juru li Cerdelga huwa effettiv għall-kura tal-marda, inkluż għat-tnaqqis tad-daqs ta' tkabbir filmilsa u l-fwied.
English: All patients who are prescribed Cerdelga will be provided with a patient alert card. All healthcare professionals who are expected to prescribe Cerdelga will be provided with a prescriber guide.
Maltese: Il-professjonisti kollha fil-qasam tal-kura tas-saħħa li huma mistennija li jippreskrivu Cerdelga se jingħataw gwida ta' preskrizzjoni.
English: Studies show that Cerdelga is effective in improving the symptoms of the disease for a majority of previously untreated patients with type-1 Gaucher disease and in keeping the disease stable in most patients previously treated by enzyme replacement.
Maltese: L-istudji juru li fil-maġġoranza ta' pazjenti li ma kinux ħadu kura qabel għall-marda Gaucher tat-tip 1, Cerdelga huwa effettiv biex inaqqas is-sintomi tal-marda u biex iżomm il-marda stabbli fil-biċċa l-kbira tal-pazjenti li qabel kienu kkurati b'sostituzzjoni tal-enzimi.
English: The most common side effect seen with Cerdelga is dyspepsia (heartburn) in approximately 6 out of 100 patients.
Maltese: L- effett sekondarju l-aktar komuni manifestat, riżultat tat-teħid ta' Cerdelga, huwa dispepsja (ħruq ta' stonku), b'madwar 6 minn kull 100 pazjent.
English: How does Cerdelga work?
Maltese: Kif jintuża Cerdelga?
English: Patients who break down the medicine at normal speed take 1 capsule twice a day, while those who break down the medicine slowly take 1 capsule once a day.
Maltese: Pazjenti li jkissru lmediċina b'veloċità normali jieħdu kapsula waħda darbtejn kuljum, filwaqt li dawk li jkissru l-mediċina bil-mod jieħdu kapsula waħda darba kuljum.
English: The active substance is:
Maltese: Is-sustanza attiva hi:
English: CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows
Maltese: Pty Ltd 189-209 Camp Road Broadmeadows
English: Date of first authorisation: 12 August 2013 Date of latest renewal: 26 April 2018
Maltese: 12 ta' Awissu 2013 Data tal-aħħar tiġdid: 26 ta' April 2018
English: MedDRA Standard System Organ Class
Maltese: Organi Standard MedDRA
English: parameter
Maltese: parameteru
English: See section 2 “Voncento contains sodium”.
Maltese: Ara sezzjoni 2 “Voncento fih sodium”.
English: Half-life (h)
Maltese: Half-life (sigħat)
English: Store below 25 °C.
Maltese: Aħżen f'temperatura taħt 25°C.
English: Uncommon (PTPs)** Very common (PUPs)**
Maltese: Mhux komuni (PTPs)** Komuni ħafna (PUPs)** Mhux magħruf***
English: Haemophilia A
Maltese: Emofilja A
English: Voncento contains approximately 128.2 mmol/l (2.95 mg/ml) of sodium.
Maltese: Voncento fih madwar 128.2 mmol/l (2.95 mg/ml) ta 'sodju.
English: Haemophilia A (congenital FVIII deficiency)
Maltese: Emofilija A (defiċjenza konġenita ta' FVIII)
English: *** Observed during postmarketing surveillance, not observed in clinical trials.
Maltese: *** Osservati waqt sorveljanza wara t-tqegħid fis-suq, mhux osservati fi provi kliniċi.
English: Calcium chloride Human albumin Sodium chloride Sodium citrate Sucrose
Maltese: Calcium chloride Albumina tal-bniedem Sodium chloride Sodium citrate
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Maltese: • testijiet ta' kull donazzjoni u ġabra ta' plażma għal sinjali tal-vajrus/infezzjonijiet,
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Trombin imbagħad jikkonverti fibrinogen ġo fibrin u jista' jifforma demm magħqud (clots).
English: The relative content of HMW (high molecular weight) VWF multimers in Voncento is on average 86 % when compared to normal human plasma (NHP).
Maltese: Il-kontenut relattiv ta' multimers ta' HMW (high molecular weight - piż molekulari għoli) ta' VWF f'Voncento hu medja ta' 86% meta mqabbel ma' plażma normali ta' bniedem (normal human plasma, NHP).
English: Other medicines and Voncento
Maltese: Mediċini oħra u Voncento
English: There are no data on fertility available.
Maltese: M'hemmx dejta disponibbli dwar il-fertilità.
English: - VWF produces delayed correction of the associated FVIII deficiency.
Maltese: - VWF jikkawża korrezzjoni ritardata tad-defiċjenza FVIII assoċjata.
English: Required units = body weight [kg] x desired factor VIII rise [% or IU/dl] x 0.5.
Maltese: Unitajiet meħtieġa = piż tal-ġisem [kg] x żieda mixtieqa ta' fattur VIII [% jew IU/dl] x 0.5.
English: von Willebrand disease (VWD)
Maltese: Marda von Willebrand (VWD)
English: Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Il-frekwenzi kienu evalwati skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (<1/10,000),
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Maltese: Il-prekawzjonijiet li jittieħdu jistgħu jkunu ta' valur limitat kontra vajruses mhux miksijin bħal parvovirus B19.
English: Levels of VWF:RCo of > 0.6 IU/ml (60 %) and of FVIII:C of > 0.4 IU/ml (40 %) should be achieved.
Maltese: Livelli ta' VWF:RCo ta' > 0.6 IU/ml (60 %) u ta' FVIII:
English: Voncento contains sodium
Maltese: Voncento fih sodium
English: -not applicable
Maltese: -ma japplikax
English: 50 IU/ml FVIII and 120 IU/ml VWF.
Maltese: IU/ml FVIII u 120 IU/ml VWF.
English: Other ingredients: calcium chloride, human albumin, sodium chloride, sodium citrate, sucrose, trometamol.
Maltese: L-ingredjenti l-oħra : calcium chloride, human albumin, sodium chloride, sodium citrate, sucrose, trometamol.
English: Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by 0.02 IU/ml (2 %).
Maltese: Ġeneralment, 1 IU/kg VWF:RCo jgħolli l-livell ta' VWF:RCo fiċ-ċirkolazzjoni b'0.02 IU/ml (2 %).
English: CSL Behring GmbH, 35041 Marburg, Germany
Maltese: CSL Behring GmbH, 35041 Marburg, Il-Ġermanja
English: Thromboembolic events
Maltese: Episodji tromboemboliċi:
English: Voncento 1000 IU / 2400 IU
Maltese: Voncento 1000 IU FVIII/2400
English: CSL Behring s.r.o.
Maltese: Česká republika CSL Behring s.r.o.
English: Collagen Binding; VWF:RCo = von Willebrand factor: Ristocetin Cofactor, FVIII:C = Factor VIII: Coagulant
Maltese: Irbit mal-Kollaġen; VWF:RCo = fattur von Willebrand: Kofattur Ristocetin, FVIII:C
English: Incremental recovery (IU/mL)/(IU/kg) Half-life (h)
Maltese: (IU/mL)/(IU/kg) Half-life
English: Trometamol
Maltese: Sucrose Trometamol
English: N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) <6 years 6-12 years <6 years 6-12 years <6 years 6-12 years <6 years 6-12 years
Maltese: medjan (firxa) <6 snin 6-12-il sena <6 snin 6-12-il sena <6 snin 6-12-il sena <6 snin 6-12-il sena
English: Tel: +385 (1) 631-1833
Maltese: PharmaSwiss d.o.o. Tel: +385 (1) 631-1833
English: Tmax (h)
Maltese: Tmax (siegħa)
English: Voncento 500 IU / 1200 IU
Maltese: IU/1200 IU
English: Based on a pharmacokinetic study with 12 subjects ≥12 years with VWD, the following pharmacokinetic characteristics for VWF:RCo, VWF:Ag, VWF:CB and FVIII:C were observed:
Maltese: Ibbażat fuq studju farmakokinetiku bi 12 individwu ≥12-il sena b'VWD, il-karatteristiċi farmakokinetiċi li ġejjin għal VWF:RCo, VWF:Ag, VWF:CB u FVIII:C kienu osservati:
English: The ratio between FVIII:C and VWF:RCo in a vial is approximately 1:2.4.
Maltese: Il-proporzjon bejn FVIII:C u VWF:RCo f'kunjett huwa madwar 1:2.4.
English: <6 years
Maltese: <6 snin
English: Baseline-adjusted initial PK parameters of FVIII:C in subjects <6 (N=15) and 6-12 years old (N=16) FVIII:C
Maltese: C aġġustati għal-linja bażi f'individwi <6 (N=15) u bejn 6-12-il sena (N=16)
English: human coagulation factor VIII 1000 IU human von Willebrand factor 2400 IU
Maltese: INDIVIDWALI fattur tal-koagulazzjoni VIII 1000 IU fattur von Willebrand 2400
English: Hypersensitivity or allergic reactions, thromboembolic events, pyrexia, headache, dysgeusia and abnormal liver function test levels.
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi, episodji tromboembolitiċi, deni, uġigħ ta' ras, disgewżja u livelli anormali tattestijiet tal-fwied.
English: Liver function test abnormal
Maltese: Test tal-funzjoni tal-fwied anormali
English: Ristocetin Cofactor, FVIII:C = Factor VIII: Coagulant
Maltese: Ko-fattur Ristocetin, FVIII:C
English: Тел: +359 2 850 8617
Maltese: Новимед Фарма EООД Тел: +359 2 850 8617
English: For safety with respect to transmissible agents, see section 4.4.
Maltese: Għas-sigurtà mil-lat ta' sustanzi li jistgħu jiġu trasmessi, ara sezzjoni 4.4.
English: Incremental recovery (IU/mL)/(IU/kg)
Maltese: Irkupru inkrementali (IU/mL)/(IU/kg)
English: EXPIRY DATE
Maltese: Data meta Jis
English: The injection/infusion rate should not exceed 6 ml per minute.
Maltese: Ir-rata ta' injezzjoni/infużjoni m'għandhiex taqbeż 6 mL fil-minuta.
English: • Taste alteration (dysgeusia)
Maltese: • Bidla fit-togħma (disgewżja)
English: Bring the solvent to room temperature.
Maltese: Ħalli s-solvent jilħaq it-temperatura ambjentali.
English: Frequency of doses (hours) / Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat) / Tul tat-terapja (ġranet)
English: Baseline-adjusted initial PK parameters of VWF and FVIII:C in subjects <6 (N=9) and 6-12 years old (N=5)
Maltese: C aġġustati fil-linja bażi f'individwi <6 snin (N=9) u 6-12-il sena (N=5)
English: EU/1/13/857/003
Maltese: FIS-SUQ EU/1/13/857/003
English: Haemorrhage
Maltese: Preżentazzjonijiet
English: Prophylaxis treatment
Maltese: Trattament bi profilassi
English: How to store Voncento
Maltese: Tużax Voncento
English: 1 disposable 10 ml syringe 1 venipuncture set 2 alcohol swabs
Maltese: Siringa 1 ta' 10 ml li tintrema wara li tintuża Sett 1 għat-titqib tal-vina 2 imselħiet bl-alkoħol
English: Tel: +386 1 25 71 496
Maltese: MediSanus d.o.o. Tel: +386 1 25 71 496
English: The specific VWF activity of Voncento, prior to the addition of stabiliser, is approximately 100 IU of VWF/mg protein.
Maltese: L-attività speċifika ta' Voncento, qabel ma jiġi miżjud l-istabilizzatur, hija madwar 100 IU VWF/mg ta' proteina.
English: The FVIII/VWF complex consists of two molecules (FVIII and VWF) with different physiological functions.
Maltese: Il-kumpless FVIII/VWF jikkonsisti f'żewġ molekoli (FVIII u VWF) b'funzjonijiet fiżjoloġiċi differenti.
English: AUC = area under the curve; Cmax = maximum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration occurs; Vss = volume of distribution at steady state; VWF:Ag = von Willebrand factor: Antigen; VWF:CB = von Willebrand factor: Collagen Binding; VWF:RCo = von Willebrand factor:
Maltese: MRT = medja tal-ħin residenti; N = numru ta' individwi; tmax = ħin sakemm tintlaħaq l-ogħla konċentrazzjoni; Vss = volum ta' distribuzzjoni fi stat fiss; VWF:Ag = fattur von Willebrand: Antiġen; VWF:CB = fattur von Willebrand:
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at room temperature (below 25 °C).
Maltese: Wara r-rikostituzzjoni l-istabilità kimika u fiżika waqt l-użu intweriet għal 8 sigħat f'temperatura ambjentali (taħt 25 °C).
English: - 600 IU*** human von Willebrand factor** (VWF).
Maltese: IU*** fattur von Willebrand tal-bniedem (VWF).
English: MRT (h)
Maltese: MRT (sigħat)
English: PK parameters from the repeat PK evaluation were similar to those from initial PK. Voncento exposure and disposition were comparable between <6-year-old and 6-12-year-old subjects.
Maltese: Parametri ta' PK mill-evalwazzjoni ripetuta ta' PK kienu simili għal dawk mill-PK inizjali. Lesponiment u d-dispożizzjoni għal Voncento kienu komparabbli bejn individwi <6 snin u dawk bejn 612-il sena.
English: 2 alcohol swabs
Maltese: 2 imselħiet bl-alkoħol
English: CSL Behring sp. z o.o.
Maltese: CSL Behring S.p.A.
English: Pharmacotherapeutic group: antihaemorrhagics,blood coagulation factors, von Willebrand factor and coagulation factor VIII in combination, ATC code: B02BD06
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, fatturi tal-koagulazzjoni tad-demm, fattur von Willebrand u fattur VIII tal-koagulazzjoni f'kombinazzjoni.
English: Name and address of the manufacturer(s) responsible for batch release CSL Behring GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur CSL Behring GmbH
English: There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors.
Maltese: Hemm riskju li jseħħu episodji trombotiċi, l-aktar b'fatturi kliniċi jew tal-laboratorju magħrufa għarriskju.
English: Voncento can be used for all age groups.
Maltese: Voncento jista 'jintuża għall-etajiet kollha.
English: * The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Maltese: 1 Il-qawwa ta' FVIII (IU) tiġi determinata permezz ta' essej kromoġeniku mill-Farmakopeja Ewropeja.
English: Voncento 250 IU / 600 IU
Maltese: IU/600 IU jew 500
English: Incremental recovery (IU/mL)/(IU/kg) 15 0.015 0.009-0.019 16 0.016 0.010-0.026 Half-life (h)
Maltese: (IU/mL)/(IU/kg) Half-life (sigħat) 8 11.53 6.05-35.10
English: This is equivalent to 1.48% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.48% tad-doża rakkomandata ta 'kuljum ta' sodju għal adult.
English: • von Willebrand disease
Maltese: • Marda von Willebrand
English: Life-threatening haemorrhages:
Maltese: Data tal-ewwel awtorizzazzjoni:
English: Prophylaxis against venous thromboembolism should be instituted, according to the current recommendations.
Maltese: Profilassi kontra tromboembolismi fil-vini għandha tingħata, skont ir-rakkomandazzjonijiet kurrenti.
English: Based on a pharmacokinetic study with 16 subjects ≥ 12 years of age with haemophilia A, the following pharmacokinetic characteristics for FVIII:C were observed:
Maltese: Abbażi ta' studju farmakokinetiku b'16-il individwu b'età ta' ≥ 12-il sena b'emofilija A, kienu osservati l-karatteristiċi farmakokinetiċi li ġejjin għal FVIII:C:
English: CSL Behring S.A. Tél: + 33 -(0)-1 53 58 54 00
Maltese: Tél: + 33 -(0)-1 53 58 54 00
English: The table presented below is according to the MedDRA system organ classification.
Maltese: It-tabella ta' hawn taħt hija skont il-klassifika tal-organi tas-sistema MedDRA.
English: • Abnormal liver function test
Maltese: • Riżultat mhux normali tat-test tal-funzjoni tal-fwied
English: Common Very common
Maltese: Komuni Komuni ħafna