FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, trattament mediku standard għal xokk għandu jiġi implimentat.
English: Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF).
Maltese: Vonicog alfa hu fattur von Willebrand uman rikombinanti purifikat (rVWF).
English: This is equivalent to 2.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult, assuming a body weight of 70 kg and a dose of 80 IU/kg body weight.
Maltese: Dan huwa ekwivalenti għal 2.2% tad-doża massima ta' kuljum rakkomandata mill-WHO ta' 2 g ta' sodium għal adult, jekk wieħed jassumi piż tal-ġisem ta' 70 kg u doża ta' 80 IU/kg piż tal-ġisem.
English: Initial Dose a
Maltese: ANNESS II A.
English: VWF:RCo Target Peak Plasma Level
Maltese: VWF:RCo Livell Minimu fil-Mira fil-Plażma
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 3 sigħat f'temperatura ta' 25°C.
English: Table 3 Recommended Target Trough Plasma Levels of VWF:RCo and FVIII:C and Minimum Duration of Treatment for Subsequent Maintenance Doses for the Prevention of Excessive Bleeding During and After Surgery
Maltese: Tabella 3 Livelli Minimi fil-Mira Rakkomandati ta' VWF:RCo u FVIII:C fil-Plażma u t-Tul Minimu tat-Trattament għal Dożi Sussegwenti ta' Manteniment għall-Prevenzjoni ta' Ħruġ ta' Demm Eċċessiv Wara Operazzjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1298/002
English: For minor bleeding (e.g. nose bleed, oral bleeding, menorrhagia), each initial dose is usually 40 to 50 IU/kg and for major bleeding (severe or refractory nose bleed, menorrhagia, gastrointestinal bleeding, Central nervous system trauma, haemarthrosis, or traumatic haemorrhage), each initial dose is 50 to 80 IU/kg.
Maltese: IU/kg u għal ħruġ ta' demm maġġuri (epistassi severa jew refrattarja, menorraġija, ħruġ ta' demm gastro-intestinali, trawma fis-sistema nervuża ċentrali, emartrożi, jew emorraġija trawmatika), kull doża tal-bidu hija ta' 50 sa 80 IU/kg.
English: Number and Frequency by Subject a
Maltese: Numru u Frekwenza Skont l-Individwu a
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1298/001
English: 1 vial contains 650 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 5 mL water for Injections
Maltese: IU vonicog alfa, madwar 130 IU/mL wara r-rikostituzzjoni b'5 mL ta' ilma għall-Injezzjonijiet
English: The potency of VWF (IU) is measured using the European Pharmacopeia ristocetin cofactor activity assay (VWF: RCo).
Maltese: Il-qawwa ta' VWF (IU) titkejjel bl-użu tal-assaġġ tal-Farmakopea Ewropea għall-attività tal-kofattur ristocetin (VWF: RCo).
English: Do not mix VEYVONDI with other medicinal products except for rFVIII.
Maltese: Tħallatx VEYVONDI ma' prodotti mediċinali oħra minbarra ma' rFVIII.
English: After 72 hours post surgery
Maltese: 72 siegħa wara l-operazzjoni
English: Binding antibodies against impurities such as rFurin, CHO-protein or mouse IgG were not observed after treatment with VEYVONDI.
Maltese: Antikorpi li jeħlu kontra impuritajiet bħal rFurin, proteini CHO jew IgG tal-ġrieden, ma ġewx osservati wara t-trattament b'VEYVONDI.
English: In clinical trials, one case of clinically asymptomatic deep vein thrombosis (DVT) was reported for a subject in the surgery study who had total hip replacement.
Maltese: Fil-provi kliniċi, każ wieħed ta' trombożi tal-vini profondi (DVT, deep vein thrombosis) klinikament asintomatika ġie rrappurtat għal individwu fl-istudju kirurġiku li kellu sostituzzjoni totali tal-ġenbejn.
English: Patients and/or their caregivers should be informed of the early signs of hypersensitivity reactions, which may include but are not limited to tachycardia, tightness of the chest, wheezing and/or acute respiratory distress, hypotension, generalised urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, restlessness, and may progress to anaphylactic shock.
Maltese: Il-pazjenti u/jew il-persuni li jieħdu ħsiebhom, għandhom jiġu infurmati bis-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva, li jistgħu jinkludu, iżda mhumiex limitati għal, takikardija, tagħfis tas-sider, tħarħir u/jew problemi akuti respiratorji, pressjoni baxxa, urtikarja ġeneralizzata, ħakk, rinokonġuntivite, anġjoedema, letarġija, dardir, rimettar, parestesija, irrekwitezza, u jistgħu jaggravaw għal xokk anafilattiku.
English: VEYVONDI 650 IU powder and solvent for solution for injection Each pack contains: - powder in a vial (type I glass), with a butyl rubber stopper - 5 mL of solvent in a vial (type I glass), with a rubber stopper (chlorobutyl) - one reconstitution device (Mix2Vial)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Kull pakkett fih: - trab f'kunjett (ħġieġ ta' tip I), b'tapp tal-lastku tal-butyl - 5 mL ta' solvent f'kunjett (ħġieġ ta' tip I), b'tapp tal-lastku (chlorobutyl) - tagħmir wieħed għar-rikostituzzjoni (Mix2Vial)
English: Fertility The effects of VEYVONDI on fertility have not been established.
Maltese: Fertilità L-effetti ta' VEYVONDI fuq il-fertilità ma ġewx stabbiliti.
English: Chest discomfort
Maltese: Disturbi Vaskulari
English: You can store the reconstituted product at room temperature not to exceed 25° C for up to three hours.
Maltese: Tista' taħżen il-prodott rikostitwit fit-temperatura tal-kamra li ma taqbiżx 25°C għal sa tliet sigħat.
English: No treatment-emergent development of neutralizing antibodies against human VWF or neutralizing antibodies against human rFVIII was observed.
Maltese: Ma kien hemm l-ebda żvilupp ta' antikorpi newtralizzanti kontra VWF uman jew antikorpi newtralizzanti kontra rFVIII uman li seħħ minħabba t-trattament.
English: Frequency of dosing
Maltese: Frekwenza tad-dożaġġ
English: FVIII products may contain varying amounts of VWF.
Maltese: Prodotti ta' FVIII jista' jkun fihom ammonti li jvarjaw ta' VWF.
English: Prevention of bleeding/haemorrhage and treatment in case of elective surgery Assess FVIII:C levels prior to initiation of any surgical procedure.
Maltese: Prevenzjoni ta' ħruġ ta' demm/emorraġija u trattament f'każ ta' operazzjoni elettiva Evalwa l-livelli ta' FVIII:C qabel il-bidu ta' kwalunkwe proċedura kirurġika.
English: Slowly infuse VEYVONDI.
Maltese: Agħti l-infużjoni ta' VEYVONDI bil-mod.
English: Haemorrhage
Maltese: Maġġuri
English: 3 Open the Mix2Vial device package by completely peeling away the lid, without touching the inside of the package.
Maltese: 3 Iftaħ il-pakkett tat-tagħmir Mix2Vial billi tqaxxar kompletament l-għatu, mingħajr ma tmiss in-naħa ta' ġewwa tal-pakkett.
English: VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF).
Maltese: VEYVONDI fih is-sustanza attiva vonicog alfa, li hija fattur von Willebrand rikombinanti uman (rVWF).
English: Thrombolism and embolism
Maltese: Trombożi u Emboliżmu
English: 1 vial contains1300 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 10 mL Water for Injections
Maltese: IU vonicog alfa, madwar 130 IU/mL wara r-rikostituzzjoni b'10 mL ta' Ilma għall-Injezzjonijiet
English: VEYVONDI is a recombinant human von Willebrand factor (rVWF).
Maltese: VEYVONDI hu fattur von Willebrand uman rikombinanti (rVWF, recombinant human von Willebrand factor).
English: Frequency by Subject: Total number of subjects experiencing the AE (related and unrelated) divided by total number of subjects (N) and multiplied by 100.
Maltese: Numru totali ta' individwi li jesperjenzaw l-avvenimenti avversi (relatati u mhux relatati) diviż bin-numru totali ta' individwi (N) immultiplikat b'100.
English: Prior to Surgery:
Maltese: Matul u Wara Operazzjoni
English: The rFVIII dose should be calculated according to the difference between the patient's baseline plasma FVIII:C level, and the desired peak FVIII:C level to achieve an appropriate plasma FVIII:C level based on the approximate mean recovery of 0.02 (IU/mL)/(IU/kg).
Maltese: Id-doża ta' rFVIII għandha tiġi kkalkulata skont id-differenza bejn il-livell tal-pazjent ta' FVIII:C fil-plażma fil-linja bażi, u l-livell massimu ta' FVIII:C, sabiex jinkiseb livell adattat ta' FVIII:C fil-plażma bbażat fuq l-irkupru medju approssimattiv ta' 0.02 (IU/mL)/(IU/kg).
English: What VEYVONDI contains The active substance is vonicog alfa (recombinant human von Willebrand factor).
Maltese: Is-sustanza attiva hi vonicog alfa (fattur von Willebrand uman rikombinanti).
English: Based on experience from clinical studies, once VWF has been replaced, endogenous FVIII levels will remain normal or near normal as long as VEYVONDI is continued to be administered.
Maltese: Ibbażat fuq l-esperjenza mill-istudji kliniċi, ġaladarba VWF ikun ġie sostitwit, il-livelli ta' FVIII endoġenu se jibqgħu normali jew qrib in-normali sakemm VEYVONDI ikompli jingħata.
English: Pharmacotherapeutic group: Antihaemorrhagics: blood coagulation factor von Willebrand factor.
Maltese: Antiemorraġiċi: fattur tal-koagulazzjoni tad-demm fattur von Willebrand.
English: It is manufactured by recombinant DNA (rDNA) technology in the Chinese Hamster Ovary (CHO) cell line without the addition of any exogenous human-or animal-derived protein in the cell culture process, purification or final formulation.
Maltese: Hu prodott permezz ta' teknoloġija ta' DNA rikombinanti (rDNA) f'razza ta' ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO, Chinese Hamster Ovary), mingħajr iż-żieda ta' kwalunkwe proteina esoġena derivata mill-bniedem jew mill-annimali, fil-proċess tal-koltura, purifikazzjoni jew formulazzjoni finali taċ-ċelluli.
English: If the FVIII:C levels are not at the recommended target levels, rFVIII should be administered in addition to vonicog alfa to raise VWF:RCo and FVIII:C. Please refer to (Table 2) for FVIII:C recommended target levels.
Maltese: Jekk il-livelli ta' FVIII:C ma jkunux fil-livelli rakkomandati tal-mira, rFVIII għandu jingħata flimkien ma' vonicog alfa biex jgħolli VWF:RCo u FVIII:C, fi żmien siegħa (1) qabel il-proċedura.
English: Administer a subsequent dose of 40 IU to 60 IU/kg of VEYVONDI infused every 8 to 24 hours as per the dosing ranges in Table 1, as long as clinically required.
Maltese: IU/kg ta' VEYVONDI mogħtija bħala infużjoni kull 8 sa 24 siegħa skont il-meded tad-dożaġġ f'Tabella 1, sakemm ikun klinikament xieraq.
English: Table 1 Dosing recommendations for the treatment of Minor and Major Haemorrhages
Maltese: Tabella 1 Rakkomandazzjonijiet tad-dożaġġ għat-trattament ta' emorraġiji minuri u maġġuri
English: Table 1 Dosing recommendations for the treatment of minor and major haemorrhages
Maltese: Tabella 1 Rakkomandazzjonijiet tad-dożaġġ għat-trattament ta' Emorraġiji Minuri u Maġġuri
English: VEYVONDI is indicated in adults (age 18 and older) with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the - Treatment of haemorrhage and surgical bleeding - Prevention of surgical bleeding.
Maltese: VEYVONDI huwa indikat f'adulti (li jkollhom 18-il sena u aktar) bil-marda ta' von Willebrand (VWD, von Willebrand Disease), meta t-trattament b'desmopressin (DDAVP) waħdu ma jkunx effettiv jew mhux indikat għal - Trattament ta' emorraġija u ħruġ ta' demm waqt operazzjoni
English: - Use the reconstituted product within 3 hours to avoid the risk of microbial contamination because the product does not contain preservatives.
Maltese: - Uża l-prodott rikostitwit fi żmien 3 sigħat sabiex jiġi evitat ir-riskju ta' kontaminazzjoni mikrobjali, għax il-prodott ma fihx preservattivi.
English: The solution should be slowly administered intravenously (see section 4.2) not exceeding 4 mL/min.
Maltese: Is-soluzzjoni għandha tingħata bil-mod ġol-vini (ara sezzjoni 4.2) b'rata li ma taqbiżx 4 mL/min.
English: There is a risk of occurrence of thrombotic events if you have known clinical or laboratory risk factors.Therefore your doctor will monitor you for early signs of thrombosis.
Maltese: Hemm ir-riskju ta' okkorrenza ta' avvenimenti trombotiċi jekk għandek fatturi ta' riskju magħrufa kliniċi jew tal-laboratorju.
English: VEYVONDI is a rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process.
Maltese: VEYVONDI hu rVWF li fih multimers kbar ħafna flimkien mal-multimers kollha li jinsabu fil-plażma, billi mhuwiex espost għal proteolisi minn ADAMTS13 matul il-proċess tal-manifattura.
English: The filter included in the Mix2Vial device removes those particles completely.
Maltese: Il-filtru inkluż fit-tagħmir Mix2Vial ineħħi kompletament dak il-frak.
English: c a Additional rFVIII may be required to attain the recommended FVIII:C target peak plasma levels.
Maltese: c a rFVIII addizzjonali jista' jkun meħtieġ biex jintlaħqu l-livelli massimi fil-mira ta' FVIII:C fil-plażma.
English: Steps
Maltese: Passi
English: Major b
Maltese: Maġġuri b
English: In a human ex vivo placenta perfusion model, it has been demonstrated that VEYVONDI does not cross the human placenta barrier.
Maltese: F'mudell ta' perfużjoni ex vivo tal-plaċenta umana, intwera li VEYVONDI ma jaqsamx il-barriera tal-plaċenta umana.
English: After the initiation of the surgical procedure, the VWF:RCo and FVIII:C plasma levels should be monitored and the intra- and post-operative substitution regimen should be individualised according to the PK results, intensity and duration of the haemostatic challenge, and the institution's standard of care.
Maltese: Wara l-bidu tal-proċedura kirurġika, il-livelli ta' VWF:RCo u FVIII:C fil-plażma għandhom jiġu mmonitorjati, u l-kors ta' sostituzzjoni ta' waqt u wara l-operazzjoni għandu jiġi individwalizzat skont ir-riżultati PK, l-intensità u t-tul tal-isfida emostatika, u l-istandard ta' trattament tal-istituzzjoni.
English: 48 hours Every 12-24 hrs / every other day
Maltese: 48 siegħa Kull 12-24 siegħa/ kull jumejn Maġġuri > 0.50
English: In general, the frequency of VEYVONDI dosing for post-operative substitution should range from twice a day to every 48 hours.
Maltese: B'mod ġenerali, il-frekwenza tad-dożaġġ ta' VEYVONDI għal sostituzzjoni wara l-operazzjoni għandha tvarja minn darbtejn kuljum sa kull 48 siegħa.
English: Method of administration
Maltese: Industriestraße 67
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni vonicog alfa (fattur von Willebrand uman rikombinanti)
English: General Instructions - Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation.
Maltese: Istruzzjonijiet Ġenerali - Iċċekkja d-data ta' skadenza, u żgura li t-trab ta' VEYVONDI u l-ilma għall-injezzjonijiet (solvent) ikunu fit-temperatura tal-kamra qabel il-preparazzjoni.
English: Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Maltese: Aqla l-labra 'l barra mill-vina u uża garża sterili biex tagħmel pressjoni fuq is-sit tal-infużjoni għal diversi minuti.
English: Skin and subcutaneous tissue disorders
Maltese: Trombożi tal-vini profondi
English: Powder
Maltese: Mejt
English: There is a possibility of developing hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, rhinoconjunctivitis, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) which may in some cases progress to anaphylaxis (including shock).
Maltese: Hemm il-possibbiltà li jiżviluppaw reazzjonijiet ta' sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedema, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, rinokonġintivite, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet f'ġismek, takikardija, tagħfis fis-sider, tnemnim, rimettar, tħarħir), li f'xi każijiet jistgħu jaggravaw għal anafilassi (li tinkudi xokk).
English: VEYVONDI should not be used in the treatment of Haemophilia A.
Maltese: VEYVONDI m'għandux jintuża fit-trattament ta' Emofilija A.
English: Each pack of VEYVONDI 1300 IU contains: - powder in a vial (type I glass), with a butyl rubber stopper - 10 mL of solvent in a vial (type I glass), with a rubber stopper (bromobutyl) - one reconstitution device (Mix2Vial)
Maltese: Kull pakkett fih: - trab f'kunjett (ħġieġ ta' tip I), b'tapp tal-lastku tal-butyl - 10 mL ta' solvent f'kunjett (ħġieġ ta' tip I), b'tapp tal-lastku (bromobutyl) - tagħmir wieħed għar-rikostituzzjoni (Mix2Vial)
English: Calculation of rVWF dose (to be administered within 1 hour prior to surgery) (IU VWF:RCo required)
Maltese: Kalkolu tad-doża ta' rVWF (li għandha tingħata fi żmien siegħa (1) qabel l-operazzjoni) (IU VWF:RCo meħtieġ)
English: In actively bleeding patients it is recommended to co-administer a FVIII product with VEYVONDI as a first line treatment and depending on the FVIII activity levels (see section 4.2).
Maltese: F'pazjenti bi ħruġ ta' demm attiv, hu rakkomandat li jingħata fl-istess ħin prodott li fih FVIII ma' VEYVONDI bħala trattament primarju, u skont il-livelli ta' attività ta' FVIII (ara sezzjoni 4.2).
English: Side effects that have been reported with VEYVONDI that can occur commonly (up to 1 in 10 patients) are: nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, vertigo, blood clots, hot flushes, itching, high blood pressure, muscle twitching, unusual taste, and increased heart rate.
Maltese: Effetti sekondarji li ġew irrappurtati b'VEYVONDI li jistgħu jseħħu b'mod komuni (sa 1 minn kull 10 pazjenti) huma: dardir, rimettar, tnemnim jew ħruq fis-sit tal-infużjoni, skumdità fis-sider, sturdament, vertigo, emboli fid-demm, fwawar, ħakk, pressjoni tad-demm għolja, ġbid fil-muskoli, togħma mhux tas-soltu, u żieda fir-rata tat-taħbit tal-qalb.
English: 0.5-0.6 IU/mL 0.4 - 0.5 IU/mL Δ
Maltese: IU/mL > 0.30 IU/mL > 0.50
English: After reconstitution For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Wara r-rikostituzzjoni Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Subsequent Dose
Maltese: Doża Sussegwenti
English: In patients with inadequate levels of FVIII, a dose of 40-60 IU/kg VEYVONDI should be administered 12-24 hours prior to initiating elective surgery (pre-operative dose), to ensure preoperative endogenous FVIII levels of at least 0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery.
Maltese: IU/kg VEYVONDI għandha tingħata 12-24 siegħa qabel il-bidu tal-operazzjoni mhux obbligatorja (doża qabel l-operazzjoni), biex jiġu żgurati livelli ta' FVIII endoġenu ta' mill-inqas 0.4
English: If the patient's baseline plasma FVIII:C level is < 40% or is unknown and in all situations where a rapid correction of haemostasis should be achieved, such as treatment of an acute haemorrhage, severe trauma or emergency surgery, it is necessary to administer a recombinant factor VIII product with the first infusion of VEYVONDI, in order to achieve a haemostatic plasma level of FVIII:C.
Maltese: Jekk il-livell tal-pazjent ta' FVIII:C fil-plażma fil-linja bażi jkun ta' < 40% jew ma jkunx magħruf, u fis-sitwazzjonijiet kollha fejn ikollha titwettaq korrezzjoni mgħaġġla tal-emostasi, bħal trattament ta' emorraġija akuta, trawma severa jew operazzjoni ta' emerġenza, ikun meħtieġ li tagħti prodott li fih fattur VIII rikombinanti mal-ewwel infużjoni ta' VEYVONDI, sabiex jinkiseb livell emostatiku ta' FVIII:C fil-plażma.
English: How to store VEYVONDI
Maltese: X'fih VEYVONDI
English: VEYVONDI behaves in the same way as endogenous von Willebrand factor.
Maltese: VEYVONDI iġib ruħu bl-istess mod bħall-fattur von Willebrand endoġenu.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 650 IU powder vonicog alfa
Maltese: IU/kg VWF:RCo) u għoti kkombinat ta' VEYVONDI u octocog alfa (50
English: Prevention of bleeding/haemorrhage and treatment in case of elective surgery
Maltese: Prevenzjoni ta' ħruġ ta' demm/emorraġija u trattament f'każ ta' operazzjoni elettiva
English: VEYVONDI 650 IU powder and solvent for solution for injection VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni VEYONDI 1300
English: This medicine contains 5.2 mg sodium in each 650 IU vial or 10.4 mg sodium in each 1300 IU vial.
Maltese: Dan il-prodott mediċinali fih 5.2 mg ta' sodium f'kull kunjett ta' 650
English: Dosing guidance should be done based on the IR.
Maltese: Dan ser jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida dwar is-sigurtà.
English: Dosing guidelines for treatment of minor and major haemorrhages are provided in Table 1.
Maltese: Linji gwida dwar id-dożaġġ għat-trattament ta' emorraġiji minuri u maġġuri huma pprovduti f'Tabella 1.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Baxalta Manufacturing Sarl
English: Your doctor will perform tests to make sure that you have adequate levels of von Willebrand factor.
Maltese: Ma ġew irrappurtati l-ebda sintomi ta' doża eċċessiva bil-fattur von Willebrand.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial , 1 vial with solvent (10ml), 1 Mix2Vial device
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett bit-trab, 1 kunjett b'solvent (10 mL), 1 tagħmir ta' Mix2Vial.
English: Administration of von Willebrand factor (VWF) allows for correction of von Willebrand factor deficiency.
Maltese: L-għoti tal-fattur von Willebrand (VWF) jippermetti li n-nuqqas tal-fattur von Willebrand jiġi kkoreġut.
English: VEYVONDI 650 IU powder and solvent for solution for injection Each vial of powder contains nominally 650 International Units (IU) vonicog alfa.
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett ta' trab nominalment fih 650
English: The first dose of VEYVONDI should be 40 to 80 IU/kg body weight.
Maltese: L-ewwel doża ta' VEYVONDI għandha tkun ta' 40 sa 80 IU/kg ta' piż tal-ġisem.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial, 1 vial with solvent (5 mL), 1 Mix2Vial device
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett bit-trab, 1 kunjett b'solvent (5 mL), 1 tagħmir ta' Mix2Vial.
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Maltese: - Taħżinx f'temperatura 'l fuq minn 30 °C.
English: Subsequent doses (as clinically required) are 40 to 50 IU/kg every 8 to 24 hours for minor bleeds as long as deemed clinically necessary and for major bleeds 40 to 60 IU/kg for approximately 2-3 days.
Maltese: IU/kg kull 8 sa 24 siegħa għal ħruġ ta' demm minuri sakemm ikun ikkunsidrat li hu klinikament meħtieġ u ta' 40 sa 60
English: Pruritus generalized
Maltese: Doża eċċessiva
English: After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Maltese: Wara r-rikostituzzjoni bis-solvent ta' 5 mL ipprovdut, VEYVONDI jkun fih madwar 130
English: Clinical and compatibility studies were conducted to administer vonicog alfa (human von Willebrand factor) with octocog alfa (human coagulation factor) in the same syringe.
Maltese: Twettqu studji kliniċi u dwar il-kompatibbiltà biex jingħata vonicog alfa (fattur von Willebrand uman) b'octocog alfa (fattur tal-koagulazzjoni umana) fl-istess siringa.
English: Patients with VWD, especially Type 3, may develop neutralising antibodies (inhibitors) to von Willebrand factor.
Maltese: Pazjenti b'VWD, speċjalment ta' Tip 3, jistgħu jiżviluppaw antikorpi newtralizzanti (inibituri) għall-fattur von Willebrand.