FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity or allergic reactions (which may include angiooedema, burning and stinging at the infusion site, chills, flushing, headache, hives, hypotension, lethargy, nausea, rash, restlessness, tachycardia, tightness of the chest, tingling, urticaria, including generalised urticaria, vomiting, wheezing) have rarely been observed with FVIII preparations and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Is-sensittività eċċessiva jew ir-reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedema, ħruq u tingiż fis-sit tal-infużjoni, sirdat, fwawar, uġigħ ta' ras, ħorriqija, pressjoni baxxa, għejja kbira, dardir, raxx, irrikwitezza, takikardja, sider jinħass magħfus, ċenċil, urtikarja, inkluż uritkarja ġeneralizzata, rimettar, tħarħar) rarament ġew osservati b'taħlitiet ta' FVIII u f'xi każijiet jistgħu jwasslu għal anafilassi severa (li jinkludi xokk).
English: AUC (hr*IU/ml)
Maltese: AUC (hr*IU/ml) T1/2 (hr)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 February 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Frar 2017
English: How to store Vihuma 6.
Maltese: Kif taħżen Vihuma 6.
English: Remove the adapter packaging and discard.
Maltese: Neħħi l-ippakkjar tal-adapter u armi.
English: Specific studies with long-term repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with Vihuma due to the immune response to heterologous proteins in all non-human mammalian species.
Maltese: Studji speċifiċi b'għoti ripetut fuq perijodu ta' żmien twil għal tossiċità riproduttiva, tossiċità kronika, u karċinoġeniċità ma sarux b'Vihuma minħabba r-rispons immuni għal proteini eterologi fi speċi mammiferi li mhumiex umani.
English: INFORMATION IN BRAILLE Vihuma 2500
Maltese: INFORMAZZJONI BIL-BRAILLE Vihuma 2500
English: INFORMATION IN BRAILLE Vihuma 250
Maltese: INFORMAZZJONI BIL-BRAILLE Vihuma 250
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota, ir-rata ta' emorraġija fis-sena (ABR, annualised bleeding rate) mhijiex komparabbli bejn konċentrati ta' fatturi differenti u bejn studji kliniċi differenti.
English: If severe, sudden allergic reactions (anaphylactic) occur (very rare, up to 1 in 10,000), the injection must be stopped immediately.
Maltese: Jekk ikun hemm reazzjonijiet allerġiċi severi, u f'daqqa (anafilattiċi), (rari ħafna, sa 1 f'10,000 ), l-injezzjoni għandha titwaqqaf minnufih.
English: Individualised prophylaxis: Individualised PK-based prophylaxis was evaluated in 66 adult PTPs with severe haemophilia A. Following a 1-3 month standard prophylaxis phase (every other day or 3 times weekly dosing), 44 (67%) patients were switched to a dosing regimen based on their PK assessment, and 40 completed the 6 months of prophylaxis according to the assigned dosing and treatment scheme.
Maltese: Wara l-fażi ta' profilassi standard ta' 1-3 xhur (doża kull jumejn jew 3 darbiet fil-ġimgħa), 44 (67%) pazjent qalbu għal kors ta' doża bbażat fuq il-valutazzjoni tal-PK tagħhom, u 40 ikkompletaw is-6 xhur ta' profilassi skont l-iskema ta' doża u trattament assenjata lilhom.
English: No studies were performed on the mutagenic potential of Vihuma.
Maltese: Ma sarux studji dwar il-potenzjal mutaġeniku ta' Vihuma.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni tal-prodott mediċinali qabel ma jingħata, ara sezzjoni 6.6.
English: INFORMATION IN BRAILLE Vihuma 4000
Maltese: INFORMAZZJONI BIL-BRAILLE Vihuma 4000
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4000 IU/vial
Maltese: INDIVIDWALI 4000 IU/vial
English: Degree of haemorrhage/ Type of surgical procedure
Maltese: Grad ta' emorraġija/ Tip ta' proċedura kirurġika
English: All (n=20)
Maltese: (n=14)
English: PK parameters for Vihuma (Dose: 50 IU/kg) in adult previously treated patients (age 18-65 years) with severe haemophilia A (n = 20)
Maltese: IU/kg) f'pazjenti adulti trattati qabel (età 18-65 sena) b'emofilja A severa (n=20) Parametru PK
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Maltese: Il-fattur VIII/il-kumpless tal-fattur von Willebrand jikkonsisti minn żewġ molekuli (fattur VIII u l-fattur von Willebrand) b'funzjonijiet fiżjoloġiċi differenti.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 1 Powder vial, 1 pre-filled syringe, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs 1 Pre-filled syringe contains 2.5 ml water for injections.
Maltese: Kunjett 1 ta' trab, siringa 1 mimlija għal-lest, adapter 1 tal-kunjett, labra farfett 1, 2 msiħ tal-alkoħol Siringa mimlija għal-lest 1 fiha 2.5 ml ilma għal injezzjonijiet.
English: Each powder vial contains 250, 500, 1000, 2000, 2500, 3000 or 4000 IU of simoctocog alfa.
Maltese: Kull kunjett ta' trab fih 250, 500, 1000, 2000, 2500, 3000 jew 4000
English: INFORMATION IN BRAILLE Vihuma 3000
Maltese: INFORMAZZJONI BIL-BRAILLE Vihuma 3000
English: This should be taken into consideration if you are on a controlled sodium diet.
Maltese: Dan għandu jittieħed in konsiderazzjoni minn pazjenti fuq dieta ta' sodium ikkontrollat.
English: The reconstituted medicinal product is a clear, colourless solution, free from foreign particles and has a pH of 6.5 to 7.5.
Maltese: Il-prodott mediċinali rikostitwit jikkonsisti minn soluzzjoni ċara, mingħajr kulur, ħieles minn frak barrani u li għandu pH ta' 6.5 sa 7.5.
English: Detailed information on this medicine is available on the web site of the European Medicines Agency: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Vihuma 250 IU powder and solvent for solution for injection Vihuma 500 IU powder and solvent for solution for injection Vihuma 1000 IU powder and solvent for solution for injection Vihuma 2000 IU powder and solvent for solution for injection Vihuma 2500 IU powder and solvent for solution for injection Vihuma 3000 IU powder and solvent for solution for injection Vihuma 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: IU, trab u solvent għal soluzzjoni għall-injezzjoni Vihuma 3000 IU, trab u solvent għal soluzzjoni għall-injezzjoni Vihuma 4000 IU, trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: Each pack of Vihuma contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa - 1 pre-filled syringe with 2.5 ml water for injections - 1 vial adapter - 1 butterfly needle - 2 alcohol swabs
Maltese: Kull pakkett fih: - Kunjett 1 ta' trab b'250, 500, 1000, 2000, 2500, 3000 jew 4000 IU simoctocog alfa f' kunjett tal-ħġieġ ta' tip 1, magħluq b'tapp miksi bil-bromobutyl u ssiġillat b'għatu tal-aluminju li jinqala' b'saba'.
English: Weight-adjusted PK parameters for Vihuma (Dose: 50 IU/kg) in adult previously treated patients (age 18-65 years) with severe haemophilia A (n = 20)
Maltese: IU/kg) f'pazjenti adulti trattati qabel (età 18-il sena-65 sena) b'emofilja A severa (n=20) Parametru PK Kollha (n=20)
English: Vertigo
Maltese: Vertiġni
English: A non-neutralizing anti-Factor VIII antibody was detected in one adult patient (see Table 1).
Maltese: Antikorp kontra Fattur VIII mhux newtralizzanti kien osservat f'pazjent adult wieħed (ara Tabella 1).
English: Dyspnoea
Maltese: Dispneja
English: Taken out of refrigerator: _____________
Maltese: Tneħħa mill-friġġ: _____________
English: Haemorrhagic anaemia Factor VIII inhibition
Maltese: Kif għandek tuża Vihuma
English: Powder: white to off-white friable powder.
Maltese: Tagħmlux fil-friża.
English: INFORMATION IN BRAILLE Vihuma 1000
Maltese: INFORMAZZJONI BIL-BRAILLE Vihuma 1000
English: * Calculated as patients with ADR per total number of 280 trial patients, of which 190 previously treated patients (PTPs) and 90 previously untreated patients (PUPs).
Maltese: Mhux komuni* *Ikkalkulata bħala pazjenti b'ADR skont in-numru totali ta' 280 pazjent fil-provi, li minnhom 190 pazjent ġew ikkurati preċedentement (PTPs, previously treated patients) u 90 pazjent li ma ġewx ikkurati preċedentement
English: Treatment of bleeding
Maltese: Anemija emorraġika
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 International Units simoctocog alfa (800 IU/ml after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 2000 unità internazzjoni ta' simoctocog alfa (800
English: Factor VIII level required (%) (IU/dL)
Maltese: Fattur VIII ta' 30% sa 60% (IU/dL).
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 X attivat jikkonverti prothrombin għal thrombin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 International Units simoctocog alfa (16000 IU/ml after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 4000 unità internazzjoni ta' simoctocog alfa (1600
English: Toxicology studies showed that local intravenous administration and systemic exposure were well tolerated in laboratory animals (rats and cynomolgus monkeys).
Maltese: Studji tossikoloġiċi wrew li l-għoti ġol-vina lokali u l-esponiment sistemiku kienu tollerati sew f'annimali tal-laboratorju (firien u xadini ċinomolgus).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 250 International Units simoctocog alfa (100 IU/ml after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 250 unità internazzjoni ta' simoctocog alfa (100
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: Fil-każ ta' interventi kirurġiċi maġġuri, b'mod partikolari, il-monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal-koagulazzjoni (attività ta' fattur VIII fil-plażma) huwa indispensabbli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 International Units simoctocog alfa (1000 IU/ml after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 2500 unità internazzjoni ta' simoctocog alfa (1000
English: Uncommon* Uncommon* Uncommon*
Maltese: Komuni* Mhux komuni*
English: Solvent Water for injections
Maltese: Ilma għal injezzjonijiet
English: • if you are allergic to the active substance simoctocog alfa or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għas-sustanza attiva, simoctocog alfa, jew għal xi sustanza oħra ta' din ilmediċina (elenkati fis-sezzjoni 6).
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 International Units simoctocog alfa (1200 IU/ml after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 3000 unità internazzjoni ta' simoctocog alfa (1200
English: España
Maltese: Stockholm
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Maltese: jistgħu jiffurmaw b'mod komuni ħafna (aktar minn pazjent 1 minn kull 10); madankollu, pazjenti li jkunu rċivew kura b'Fattur VIII fil-passat (aktar minn 150 jum ta' kura), ir-riskju huwa mhux komuni
English: Solvent: a clear, colourless liquid.
Maltese: Solvent: likwidu ċar, mingħajr kulur.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Maltese: Il livelli fil-mira ta' fattur VIII ser jiddependu mis-severità u l-post tal-emorraġija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/001
Maltese: FIS-SUQ EU/1/16/1168/001
English: One International Unit (IU) of factor VIII activity is equivalent to the quantity of factor VIII in one ml of normal human plasma.
Maltese: Unità Internazzjonali wieħed (IU) ta' fattur VIII hu ekwivalenti għall-kwantità ta' fattur VIII f'ml wieħed ta' plażma umana normali.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Maltese: Il-qawwa (IU) hi stabbilita permezz tal-assaġġ kromoġeniku tal-Farmakopea Ewropea.
English: INFORMATION IN BRAILLE Vihuma 500
Maltese: INFORMAZZJONI BIL-BRAILLE Vihuma 500
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours when stored at room temperature.
Maltese: Wara r-rikostituzzjoni, l-istabilità kimika u fiżika waqt l-użu ġiet murija għal 24 siegħa meta miżmum f'temperatura ambjentali tal-kamra.
English: Side effects related to central venous access devices (CVAD): Catheter-related infection, general (systemic) infection and local blood clot at the catheter site.
Maltese: Infezzjoni marbuta mal-katiter; infezzjoni ġenerali (sistemika) u embolu tad-demm lokali fis-sit tal katiter.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta wara EXP.
English: Keep the reconstituted solution at room temperature.
Maltese: Żomm is-soluzzjoni rikostitwita fit-temperatura ambjentali tal-kamra.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dl.
Maltese: Il-kalkulazzjoni tad-doża meħtieġa ta' fattur VIII hi bażata fuq ir-riżultat empiriku li Unità Internazzjonali 1 (IU) ta' fattur VIII għal kull kg ta' piż tal-ġisem jgħolli l-attività ta' fattur VIII filplażma b'madwar 2% tal-attività normali jew 2 IU/dl.
English: Data have been obtained in 29 previously treated children between 2 and 5 years of age, 31 children between 6 and 12 years of age and one adolescent of 14 years.
Maltese: 31 tifel u tifla bejn l-etajiet ta' 6 snin u 12-il sena u adolexxent wieħed ta' 14-il sena.
English: Place the powder vial on an even surface and hold it. Take the adapter package and place the vial adapter over the centre of the rubber stopper of the powder vial.
Maltese: Agħfas sew 'l isfel il-pakkett taladapter sakemm il-labra tal-adapter tippenetra ġot-tapp tal-lastku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 International Units simoctocog alfa (200 IU/ml after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 500 unità internazzjoni ta' simoctocog alfa (200
English: NAME OF THE MEDICINAL PRODUCT Vihuma 250 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Vihuma 250 unità internazzjonali trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: 33 (82.5%) patients did not experience any bleeds and 36 (90.0%) patients had no spontaneous bleeds.
Maltese: 33 (82.5%) pazjent ma kellhom l ebda emorraġija u 36 (90.
English: NAME OF THE MEDICINAL PRODUCT Vihuma 2500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Vihuma 2500 unità internazzjonali trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Maltese: Il-kampjun kien ittestjat fil-laboratorju ċentrali fi tmien dilwazzjonijiet.
English: Vihuma 3000 IU contains approximately 1200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Maltese: Vihuma 3000 IU fih madwar 1200 IU/ml ta' fattur VIII ta' koagulazzjoni (rDNA) uman, simoctocog alfa wara r-rikostituzzjoni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 International Units simoctocog alfa (400 IU/ml after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 1000 unità internazzjoni ta' simoctocog alfa (400
English: PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Maltese: IU/kg) f'pazjenti tfal trattati qabel ta' età bejn 6 snin sa 12-il sena b'emofilja A severa (n=12) Parametru PK
English: NAME OF THE MEDICINAL PRODUCT Vihuma 4000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Vihuma 4000 unità internazzjonali trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: Vihuma 4000 IU powder and solvent for solution for injection.
Maltese: Vihuma 4000 IU trab u solvent għal soluzzjoni għall-injezzjoni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 250 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Maltese: U MNEJN GĦANDU JINGĦATA Vihuma 250 unità internazzjonali trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 2500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Maltese: U MNEJN GĦANDU JINGĦATA Vihuma 2500 unità internazzjonali trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Vihuma 500 unità internazzjonali trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 1000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Maltese: U MNEJN GĦANDU JINGĦATA Vihuma 1000 unità internazzjonali trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Maltese: U MNEJN GĦANDU JINGĦATA Vihuma 500 unità internazzjonali trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti).
English: Vihuma 3000 IU powder and solvent for solution for injection.
Maltese: Vihuma 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 4000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Maltese: U MNEJN GĦANDU JINGĦATA Vihuma 4000 unità internazzjonali trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 3000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Vihuma 3000 unità internazzjonali trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
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 marbut mas-sess tal-koagulazzjoni tad-demm minħabba livelli baxxi ta' fattur VIII:C u jirriżulta f'emorraġija qawwija ġol ġogi, muskoli jew organi interni, jew spontanjament jew kif jirriżulta minn trawma aċċidentali jew kirurġika.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 3000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Maltese: U MNEJN GĦANDU JINGĦATA Vihuma 3000 unità internazzjonali trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 2000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Maltese: U MNEJN GĦANDU JINGĦATA Vihuma 2000 unità internazzjonali trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 1000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Vihuma 1000 unità internazzjonali trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: Vihuma 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Maltese: Kull kunjett fih ġeneralment 3000 IU ta' fattur VIII ta' koagulazzjoni (rDNA) uman, simoctocog alfa.
English: NAME OF THE MEDICINAL PRODUCT Vihuma 2000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Vihuma 2000 unità internazzjonali trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Maltese: Dan huwa ta' importanza partikolarment meta jinbidlu l-laboratorju u/jew (i)r-‘reagents' użati fl-‘assay'.
English: Treatment of bleeding: The median dose to treat break-through bleeding episodes was 33.0 IU/kg in these patients who were on prophylaxis.
Maltese: Id-doża medjana sabiex jiġu trattati każijiet ta' emorraġija li jseħħu bejn infużjoni u oħra kienet ta' 33.0 IU/kg f'dawn il-pazjenti li kienu fuq profilassi.
English: Octapharma AB Lars Forssells gata 23 112 75 Stockholm SWEDEN
Maltese: Lars Forssells gata 23
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Vihuma
Maltese: Parametri farmakokinetiċi (pharmacokinetic properties, PK) għal Vihuma (Doża:
English: Non-neutralising antibody positive (in PTPs)
Maltese: Antikorp mhux newtralizzanti pożittiv (f'PTPs)
English: Vihuma 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Maltese: Kull kunjett fih ġeneralment 4000 IU ta' fattur VIII ta' koagulazzjoni (rDNA) uman, simoctocog alfa.
English: (<1/10,000), not known (cannot be estimated from the available data).
Maltese: (PUPs, previously untreated patients). #
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Maltese: Pazjenti għandhom jiġu infurmati dwar is-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu ħorriqija, urtikarja ġeneralizzata, sider li jinħass issikkat, tħarħar, pressjoni baxxa u anafilassi.
English: The following table can be used to guide dosing in bleeding episodes and surgery.
Maltese: tintuża bħala gwida għal dożaġġ f'episodji emorraġiċi u kirurġija.