FrancophonIA/ELRC3.0 huggingface dataset:
English: Presentations with 500 IU FVIII / 1200 IU VWF (10 ml solvent) and 1000 IU FVIII / 2400 IU VWF (10 ml solvent): contain up to 29.50 mg (1.28 mmol) sodium per vial, equivalent to 1.48% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: fihom sa 29.50 mg (1.28 mmol) sodium f'kull kunjett, ekwivalenti għal 1.48% tal-konsum massimu rakkomandat tad-WHO ta '2 g ta' sodju għal adult.
English: AM Mangion Ltd. Tel: +356 2397 6333
Maltese: Tel: +356 2397 6333
English: Following infusion, peak concentrations of VWF markers (VWF:RCo, VWF:Ag, and VWF:CB) and FVIII:C were achieved immediately with a median IR of 0.012-0.016 (IU/mL)/(IU/kg) for VWF markers and 0.018-0.020 (IU/mL)/(IU/kg) for FVIII:C. The median elimination t1/2 of VWF markers was between 10.00 and 13.48 h whereas FVIII:C had a longer t1/2 between 11.40 and 19.54 h due to a plateau effect that may represent the net effect of decreasing levels of exogenous FVIII, combined with increasing endogenous FVIII levels.
Maltese: u 13.48 sigħat, filwaqt li FVIII:C kellu t1/2 itwal bejn 11.40 u 19.54 sigħat minħabba l-effett plateau li jista' jirrapreżenta leffett nett ta' livelli li jonqsu ta' FVIII eżoġenu ikkombinat ma livelli ta' FVIII endoġenu li jiżdiedu.
English: In patients receiving FVIII-containing VWF products, sustained excessive FVIII:C plasma levels may increase the risk of thromboembolic events (see also section 4.4).
Maltese: F'pazjenti li jkunu qed jirċievu prodotti VWF li fihom FVIII, livelli sostnuti ta' FVIII:C fil-plażma jistgħu jgħollu r-riskju ta' episodji tromboemboliċi (ara wkoll sezzjoni 4.4).
English: Voncento 250 IU FVIII / 600 IU VWF powder and solvent for solution for injection/infusion Powder (250 IU/600 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: IU VWF trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni Trab (250 IU/600IU) f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku), diska (tal-plastik) u għatu (talaluminju).
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota, ir-rata annwali ta' fsada (ABR - annualized bleeding rate) mhix komparabbli bejn konċentrati ta' fatturi differenti u bejn studji kliniċi differenti.
English: 1 disposable 10 ml syringe 1 venipuncture set
Maltese: Siringa 1 ta' 10 ml li tintrema wara li tintuża Sett 1 għat-titqib tal-vina
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma, using the modified assay.
Maltese: IgG diretti lejn l-attività prokoagulanti tal-fattur VIII, li jiġu kwantifikati f'Unitajiet Bethesda (BU) għal kull ml ta' plażma billi tintuża l-analiżi modifikata (modified assay).
English: Activated FVIII 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: Fattur X attivat jikkonverti protrombin fi trombin.
English: Minor surgery including tooth extraction
Maltese: Operazzjoni minuri inkluża qlugħ ta' sinna
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Maltese: Infezzjoni bil-parvovirus B19 tista' tkun serja għal nisa waqt it-tqala (infezzjoni tal-fetu) u għal individwi b'immunodefiċjenza jew b'iżjed eritropojesi (eż anemija emolitika).
English: Prevention of haemorrhage in case of surgery:
Maltese: Prevenzjoni ta' emorraġija f'każ ta' operazzjoni:
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived factor VIII/VWF products.
Maltese: Tilqim xieraq (epatite A u B) għandu jitqies għall-pazjenti li jirċievu b'mod regolari/ripetut prodotti ta' fattur VIII/VWF derivati mill-plażma tal-bniedem.
English: The measures taken are considered effective for so-called “enveloped” viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (which cause inflammation of the liver), and for the “non-enveloped” hepatitis A virus (which also causes inflammation of the liver).
Maltese: Il-prekawzjonijiet li jittieħdu huma meqjusa effettivi kontra l-hekk imsejjħa “vajruses miksijin”, bħallvajrus tal-immunodefiċjenza tal-bniedem (HIV, il-vajrus tal-AIDS), vajrus tal-epatite B u vajrus talepatite C (infjammazzjoni tal-fwied), u għal vajrus “mhux miksi” tal-epatite A (li jikkawża wkoll infjammazzjoni tal-fwied).
English: Presentations with 250 IU FVIII / 600 IU VWF (5 ml solvent) and 500 IU FVIII / 1200 VWF IU (5 ml solvent): contain up to 14.75 mg (0.64 mmol) sodium per vial, equivalent to 0.74% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: fihom sa 14.75 mg (0.64 mmol) sodium f'kull kunjett, ekwivalenti għal 0.74% tal-konsum massimu rakkomandat tad-WHO ta '2 g ta' sodju għal adult.
English: When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. In patients receiving FVIII-containing VWF products, plasma levels of FVIII:C should be monitored to avoid sustained excessive FVIII:C plasma levels which may increase the risk of thrombotic events, and antithrombotic measures should be considered (see also section 5.2).
Maltese: C fil-plażma għandhom jiġu monitorjati sabiex jiġu evitati livelli eċċessivi sostnuti ta' FVIII:C fil-plażma li jistgħu jżidu r-riskju ta' episodji ta' trombosi, u miżuri kontra t-trombosi għandhom jitqiesu (ara wkoll sezzjoni 5.2).
English: Usually 40 - 80 IU/kg of VWF (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.
Maltese: Is-soltu 40 - 80 IU/kg ta' VWF (VWF:RCo) li jikkorrispondu għal 20 - 40 IU FVIII:C/kg tal-piż talġisem (BW) huma rakkomandati sabiex tinkiseb emostasi.
English: * Adverse events assessed as related to administration of the Voncento **Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.
Maltese: PTPs = pazjenti kkurati qabel (previously-treated patients), PUPs = pazjenti li ma ġewx ikkurati qabel (previously-untreated patients)
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI U MANIFATTUR RESPONSABBLI
English: This is equivalent to 0.74 % of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.74% tad-doża rakkomandata ta 'kuljum ta' sodju għal adult.
English: (<1/10,000), not known (cannot be estimated from the available data).
Maltese: mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: 1 disposable 10 ml syringe
Maltese: Stikka 1 mhux sterili
English: coagulation factor VIII 500 IU von Willebrand factor 1200 IU
Maltese: IU fattur von Willebrand 1200
English: България Новимед Фарма EООД
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: AUC0-48(h*IU/mL)
Maltese: AUC0-48 (sigħat *IU/mL) MRT (sigħat)
English: One pack with 250 IU/600 IU or 500 IU/1200 IU containing: - 1 vial with powder - 1 vial with 5 ml water for injections - 1 filter transfer device 20/20 - One inner box containing:
Maltese: IU/1200 IU fih: - Kunjett 1 bit-trab - Kunjett 1 b'5 ml ilma għall-injezzjonijiet - Apparat 1 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha:
English: For intravenous use.
Maltese: IU = Unità Internazzjonali;
English: 1000 IU FVIII and 2400 IU VWF per vial; after reconstitution with 10 ml of water for injection approx. 100 IU/ml FVIII and 240 IU/ml VWF.
Maltese: IU VWF f'kull kunjett; wara r-rikostituzzjoni b'10 ml ta' ilma għall-injezzjoni madwar 100 IU/ml FVIII u 240
English: (h)
Maltese: 3. LISTA
English: Hypersensitivity (including tachycardia, chest pain, chest discomfort and back pain)
Maltese: Sensittività eċċessiva (inklużi takikardija, uġigħ fis-sider, skomdità fis-sider u uġigħ fiddahar)
English: Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.
Maltese: Is-soltu 40 - 80 IU/kg ta' fattur von Willebrand (VWF:RCo) li jikkorrispondu għal 20 - 40 IU FVIII:C/kg tal-piż tal-ġisem (BW) huma rakkomandati sabiex tinkiseb emostasi.
English: - 1000 IU* human coagulation factor VIII** (FVIII).
Maltese: IU* fattur tal-koagulazzjoni tal-bniedem VIII** (FVIII).
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 (including chest pain and chest discomfort), back pain, tingling, vomiting, wheezing) have been observed, and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva (reazzjonijiet allerġiċi): Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedema, ħruq jew tingiż mnejn tingħata l-infużjoni, dehxiet, fwawar, urtikarja mal-ġisem kollu, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, nawżeja, irrikwjetezza, takikardija, għafsa fis-sider (inkluż uġigħ fis-sider u skomdità fis-sider), uġigħ fid-dahar, tingiż, rimettar, tħarħir) kienu osservati, u jistgħu f'xi każijiet jaggravaw f'anafilassi severa (inkluż xokk).
English: (h*IU/mL)
Maltese: (sigħat*IU/mL)
English: GENERAL CLASSIFICATION FOR SUPPLY
Maltese: Rikostituzzjoni u applikazzjoni
English: Tabulated list of adverse reactions
Maltese: Deskrizzjoni ta' reazzjonijiet avversi mgħażulin
English: Surgery
Maltese: operazzjoni
English: N median range N median range N median range N median range
Maltese: Mhux meħtieġ tibdil fid-doża għall-popolazzjoni ta' nies ixjaħ.
English: Powder
Maltese: UŻU
English: Preclinical studies with repeated dose applications (chronic toxicity, carcinogenicity and mutagenicity) cannot be reasonably performed in conventional animal models due to the development of antibodies following the application of heterologous human proteins.
Maltese: Studji ta' qabel l-użu kliniku b'applikazzjoni ta' dożi ripetuti (tossiċità kronika, karċinoġeniċità u mutaġeniċità) ma jistgħux isiru b'mod raġunevoli f'mudelli konvenzjonali tal-annimali minħabba l-iżvilupp ta' antikorpi wara l-applikazzjoni ta' proteini eterologi tal-bniedem.
English: Solvent Water for injections
Maltese: Solvent Ilma għall-injezzjonijiet
English: von Willebrand disease
Maltese: Marda von Willebrand
English: VWF inhibition
Maltese: Ilma għall-injezzjonijiet
English: Exogenously administered human plasma-derived VWF behaves in the same way as endogenous VWF.
Maltese: VWF derivat mill-plażma tal-bniedem mogħti b'mod exoġenu jġib ruħu bl-istess mod ta' VWF endoġenu.
English: Paediatric VWD population
Maltese: Popolazzjoni pedjatrika b'VWD
English: FVIII inhibition
Maltese: Irkupru inkrementali
English: CSL Behring AG Wankdorfstrasse 10 3014 Bern SWITZERLAND
Maltese: Wankdorfstrasse 10
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Maltese: F'pazjenti li diġà għandhom fatturi ta' riskju kardjovaskulari, terapija ta' sostituzzjoni b'FVIII tista' żżid ir-riskju kardjovaskulari.
English: Currently available data are described in Sections 4.8and 5.2.
Maltese: Dejta disponibbli bħalissa hija deskritta f'Sezzjonijiet 4.8 u 5
English: CSL Behring AB Tlf: +46 8 544 966 70
Maltese: Tlf: +46 8 544 966 70
English: What is in this leaflet:
Maltese: Inibizzjoni ta' FVIII:
English: 1 venipuncture set
Maltese: Kunjett 1 bit-trab
English: 1 IU of FVIII activity is equivalent to that quantity of factor VIII in 1 ml of normal human plasma.
Maltese: 1 IU ta' attività FVIII hija ekwivalenti għall-dik il-kwantità ta' fattur VIII f'1 mL ta' plażma normali tal-bniedem.
English: 6-12 years
Maltese: 6-12-il sena
English: 5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: 5 ml ta' solvent f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku), diska (tal-plastik), u għatu (tal-aluminju).
English: coagulation factor VIII 250 IU von Willebrand factor 600 IU
Maltese: IU fattur von Willebrand 600
English: Presentations
Maltese: LISTA
English: 5.2 Pharmacokinetic properties von Willebrand disease
Maltese: .2 Tagħrif farmakokinetiku
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Maltese: Ħames każijiet ta' doża eċċessiva kienu rapportati minn provi kliniċi.
English: • the site and intensity of the bleeding
Maltese: • tinnota sintomi ta' reazzjonijiet allerġiċi
English: Factor VIII level required (% or IU/dl)
Maltese: ta' 30 % - 60 % (IU/dl).
English: Pyrexia Headache
Maltese: Dawn jinkludu:
English: For long term prophylaxis in patients with VWD, a dose of 25 - 40 IU VWF:RCo /kg body weight should be considered at a frequency of 1 to 3 times per week.
Maltese: Għal profilassi fuq terminu ta' żmien twil f'pazjenti b'VWD, doża ta' 25 - 40 IU VWF:RCo/kg piż tal-ġisem għandha tiġi kkonsidrata bi frekwenza ta' 1 sa 3 darbiet fil-ġimgħa.
English: PK of single dose of 50 IU FVIII/kg body weight was evaluated in 31 paediatric subjects less than 12 years of age with Haemophilia A (see Table below).
Maltese: IU FVIII/kg ta' piż tal-ġisem ġiet ivvalutata f'31 individwu pedjatriku b'età inqas minn 12-il sena bl-Emofilja A (ara t-Tabella taħt).
English: • for individuals with a weakened immune system or with an increased production of red blood cells due to certain types of anaemia (e.g. sickle cell anaemia or haemolytic anaemia).
Maltese: • għal individwi b'sistema immuni dgħajfa jew bi produzzjoni akbar ta' ċelluli ħomor tad-demm minħabba ċerti tipi ta' anemija (eż anemija tas-sickle cell jew anemija emolitika).
English: Voncento 1000 IU FVIII / 2400 IU VWF powder for solution for injection/infusion ForIV use
Maltese: IU VWF trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni Trab (1000 IU/2400
English: The vials must not be heated above body temperature (37 ºC).
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting by screwing clockwise.
Maltese: Għalhekk, pazjenti b'riskju għandhom ikunu monitorjati għal sinjali bikrija ta' trombożi.
English: Dysgeusia
Maltese: Anzjani
English: PK of single dose of 80 IU VWF:RCo/kg body weight was evaluated in paediatric subjects less than 12 years of age with severe VWD (see Table below).
Maltese: Il-PK ta' doża waħda ta' 80 IU VWF:RCo/kg piż tal-ġisem kienet evalwata f'individwi pedjatriċi iżgħar minn 12-il sena b'VWD sever (ara Tabella isfel).
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Maltese: F'każ ta' operazzjonijiet kirurġiċi maġġuri b'mod partikolari, il-monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi ta' koagulazzjoni (l-attivita tal-fattur VIII filplażma) hija indispensabbli.
English: Powder and solvent for solution for injection/infusion.
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni.
English: N median range
Maltese: Tqala u treddigħ
English: CSL Behring NV Tél/Tel: +32 15 28 89 20
Maltese: CSL Behring sp. z o.o Tel: +48 22 213 22 65
English: Allergic reactions may include the following symptoms: Swollen face, tongue, mouth or throat, difficulty in breathing and swallowing, hives, wheezing, burning and stinging where the infusion was given, chills, flushing, skin rash over the whole body, headache, fall in blood pressure, restlessness, faster heart beat, tightness of the chest (including chest pain and chest discomfort), back pain, tiredness (lethargy), nausea, vomiting, tingling.
Maltese: Reazzjonijiet allerġiċi jistgħu jinkludu s-sintomi li ġejjin: wiċċ, ilsien, ħalq jew griżmejn minfuħa, tbatija biex tieħu n-nifs jew biex tibla', ħorriqija, tħarħir, ħruq u tingiż fejn ingħatat l-infużjoni, tkexkix ta' bard, fwawar, raxx fil-ġilda mal-ġisem kollu, uġigħ ta' ras, tinżel il-pressjoni, nuqqas ta' sabar, il-qalb tħabbat aktar tgħaġġel, tagħfis fis-sider (inkluż uġigħ fis-sider u skumdità fis-sider), uġigħ fid-dahar, għeja (letarġija), nawsja, rimettar, tingiż.
English: Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
Maltese: IU VWF (5 ml solvent) u 500
English: It is important to calculate the dose using the number of IU of VWF:RCo specified.
Maltese: Huwa importanti li tikkalkula d-doża billi tuża in-numru ta' IU ta' VWF:RCo speċifikat.
English: 1 IU of factorVIII activity is equivalent to that quantity of factor VIII in 1 ml of normal human plasma.
Maltese: 1 IU ta' attività tal-fattur VIII hija ekwivalenti għall-dik il-kwantità ta' fattur VIII f'1 mL ta' plażma normali tal-bniedem.
English: 10 ml of solvent in a vial (type I glass) with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: 10 ml ta' solvent f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku) diska (tal-plastik) u għatu (tal-aluminju).
English: Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusionhuman coagulation factor VIII/human von Willebrand factor
Maltese: IU VWF(10 ml solvent) trab u solvent għal soluzzjoni għallinjezzjoni/infużjoni fattur VIII tal-koagulazzjoni tal-bniedem/fattur von Willebrand tal-bniedem
English: When infused into a haemophiliac patient, FVIII binds to VWF in the patient's circulation.
Maltese: Parametri PK inizjali ta' VWF u FVIII:
English: The presentations 500 IU FVIII /1200 IU VWF (10 ml solvent) and 1000 IU FVIII /2400 IU VWF (10 ml solvent) contain up to 29.50 mg sodium per vial (main component of cooking/table salt).
Maltese: (10 ml solvent) fihom sa 29.50 mg sodium f'kull kunjett (komponent prinċipali tal-melħ tat-tisjir/talmejda).
English: Administration set
Maltese: Rikostituzzjoni
English: 10 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: 10 ml ta' solvent f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku), diska (tal-plastik), u għatu (talaluminju).
English: CSL Behring AB Sími: +46 8 544 966 70
Maltese: Sími: +46 8 544 966 70
English: Your doctor may recommend that you consider being vaccinated against hepatitis A and B if you regularly/repeatedly receive human plasma-derived medicines such as Voncento.
Maltese: It-tabib tiegħek jista' jirrakkomanda li tikkonsidra li titlaqqam kontra l-epatite A u B jekk int tirċievi b'mod regolari/ripetut mediċini li ġejjin mill-plażma tal-bniedem bħal Voncento.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of FVIII and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: Emofilija A hija marda ereditarja relatata mas-sess tal-koagulazzjoni tad-demm minħabba livelli baxxi ta' FVIII u twassal għal fsada qawwija fil-ġogi, muskoli jew organi interni, b'mod spontanju jew inkella minħabba trawma aċċidentali jew ta' operazzjoni.
English: Prophylaxis and treatment of bleeding in patients with haemophilia A.
Maltese: Għall-prevenzjoni u l-kura ta' fsada f'pazjenti b'emofilija A.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV).
Maltese: Il-miżuri li jittieħdu huma meqjusa xierqa għall-vajrusis miksijin b'envelop bħal vajrus talimmunodefiċjenza tal-bniedem (HIV), vajrus tal-epatite (HBV) u vajrus tal-epatite C (HCV), u għallvajrus mhux miksi b'envelop tal-epatite A (HAV).
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Maltese: Armi l-kunjett tas-solvent bl-edapter blu talMix2Vial imwaħħal.
English: The immediate container of product and solvent vial consists of glass vial with a rubber stopper, plastic disc, and aluminium cap.
Maltese: Il-kontenitur immedjat tal-prodott u l-kunjett tas-solvent jikkonsisti f'kunjett tal-ħġieġ b'tapp tal- lastku, diska tal-plastik, u għatu tal-aluminju.
English: Voncento 1000 IU FVIII / 2400 IU VWF powder and solvent for solution for injection/infusion Powder (1000 IU/2400 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Maltese: IU/1200 IU) f'kunjett (ħġieġ tat-tip I), b'tapp (tal-lastku), diska (tal-plastik), u għatu (talaluminju).
English: Voncento 250 IU FVIII / 600 IU VWF powder for solution for injection/infusion For IV use
Maltese: IU VWF trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni Trab (500
English: PharmaSwiss d.o.o.
Maltese: • il-kundizzjoni medika tiegħek
English: Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusionhuman coagulation factor VIII/human von Willebrand factor
Maltese: IU VWF (5 ml solvent) trab u solvent għal soluzzjoni għallinjezzjoni/infużjoni fattur VIII tal-koagulazzjoni tal-bniedem/fattur von Willebrand tal-bniedem
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta l-ewwel rapport perjodiku aġġornat dwar is-sigurtà għal dan il-prodott fi żmien 6 xhur mill-awtorizzazzjoniSussegwentement, iddetentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Patients with VWD, especially type 3 patients, may develop neutralising antibodies (inhibitors) to VWF.
Maltese: Pazjenti b'VWD, l-aktar pazjenti tat-tip 3, jistgħu jiżviluppaw antikorpi li jinnewtralizzaw (inibituri) għal VWF.
English: CSL Behring S.p.A. Tel: +39 02 34964 200
Maltese: Tel: +39 02 34964 200
English: România
Maltese: България
English: The presentations 250 IU FVIII /600 IU VWF (5 ml solvent) and 500 IU FVIII /1200 IU VWF (5 ml solvent) contain up to 14.75 mg sodium per vial (main component of cooking/table salt).
Maltese: ml solvent) fihom sa 14.75 mg sodium f'kull kunjett (komponent prinċipali tal-melħ tat-tisjir/talmejda).
English: AUC = area under the curve; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration; Vss = volume of distribution at steady state; FVIII:C = Factor VIII: Coagulant
Maltese: MRT = medja tal-ħin residenti; N = numru ta' individwi; tmax = ħin sakemm tintlaħaq l-ogħla konċentrazzjoni; Vss = volum ta' distribuzzjoni fi stat fiss; FVIII:C
English: One pack with 500 IU/1200 IU or 1000 IU/2400 IU containing: - 1 vial with powder - 1 vial with 10 ml water for injections - 1 filter transfer device 20/20 - One inner box containing:
Maltese: IU fih: - Kunjett 1 bit-trab - Kunjett 1 b'10 ml ilma għall-injezzjonijiet - Apparat 1 20/20 biex tiffiltra u tittrasferixxi Kaxxa waħda ta' ġewwa li fiha:
English: Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion human coagulation factor VIII/human von Willebrand factor
Maltese: IU VWF (5 ml solvent) trab u solvent għal soluzzjoni għall injezzjoni/infużjoni fattur VIII tal-koagulazzjoni tal-bniedem/fattur von Willebrand tal-bniedem