FrancophonIA/ELRC3.0 huggingface dataset:
English: • the preparation of the selected paraspinal site where the intended implantation will occur
Maltese: • il-metodi rrakkomandati tar-rikostituzzjoni tal-prodott qabel l-impjantazzjoni
English: • the methods for soft tissue closure around the implant.
Maltese: • il-metodi tal-għeluq tat-tessut artab madwar l-impjant.
English: • the risks of ectopic bone formation interaction with bone void fillers that the product should only be used once - details of the post marketing surveillance studies including information on how to enroll patients
Maltese: • li l-prodott għandu jintuża darba biss - dettalji ta' studji tas-sorveljanza ta' wara t-tqegħid fis-suq inkluż tagħrif dwar kif tingaġġa pazjenti
English: • the recommended manner of placement of the material together with some comments on the importance of local haemostasis
Maltese: • Sensittività eċċessiva u formazzjoni ta' antikorpi
English: It contains the active substance daclizumab (5 mg/ml).
Maltese: Fih is-sustanza attiva daclizumab (5 mg/ml).
English: Medicinal product no longer authorise©EMEA 2007
Maltese: ©EMEA 2007
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZENAPAX EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) ZENAPAX Sommarju ta' l-EPAR għall-pubbliku
English: azathioprine.
Maltese: Il-miżura
English: The active substance in Zenapax, daclizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Zenapax, daclizumab, hija antikorp monoklonali.
English: The most common side effects (seen in more than 1 patient in 10) were insomnia (difficulty sleeping), tremor (shaking), headache, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, diarrhoea, vomiting, nausea (feeling sick), dyspepsia (heartburn), musculoskeletal pain (pain in the muscles and joints), oedema (swelling), impaired healing and post-traumatic pain (pain after surgery).
Maltese: L-aktar effetti sekondarji komuni (dehru f'aktar minn pazjent 1 minn kull 10) kienu insomnja (diffikultà fl-irqad), rogħda, uġigħ ta' ras, pressjoni għolja tad-demm, dispnija (diffikultà fit-teħid tan-nifs), stitikezza, dijarea, remettar, nawżja (dardir), dispepsja (ħruq ta' stonku), uġigħ muskoloskeletali (uġigħ fil-muskoli u l-ġogi), edima (nefħa), fejqan imxekkel u uġigħ ta' wara t-trawma (uġigħ wara l-kirurġija).
English: This summary was last updated in 10-2007.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2007.
English: In the second study, 39 (28%) of the 141 adults adding Zenapax to ciclosporin, prednisone and azathioprine experienced rejection of the kidney, compared with 63 (47%) of the 134 adding placebo.
Maltese: Fit-tieni studju, 39 (28%) mill-141 adult li żiedu Zenapax ma' ciclosporin, prednisone u azathioprine esperjenzaw irrifjutar tal-kilwa, meta mqabbla ma' 63 (47%) mill-134 li żiedu plaċebo.
English: The marketing authorisation was renewed on 26 February 2004.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fis-26 ta' Frar 2004.
English: The recommended dose for adults and children is 1 mg per kilogram body weight, diluted in 50 ml sterile saline solution and given over 15 minutes.
Maltese: Id-doża irrikkmandata għal adulti u tfal hija 1 mg għal kull kilogramm piż korporju, dilwit f'50 ml soluzzjoni ta' salina sterili u mogħti fuq 15-il minuta.
English: It is used together with other immunosuppressive (anti-rejection) medicines including ciclosporin and corticosteroids.
Maltese: Huwa jintuża flimkien ma' mediċini immunosoppressivi (kontra l-irrifjutar) oħra inklużi ciclosporin u kortikosterojdi.
English: In the first study, 28 (22%) of the 126 adults adding Zenapax to ciclosporin and prednisone experienced rejection, compared with 47 (35%) of the 134 adding placebo.
Maltese: Fl-ewwel studju, 28 (22%) mill-126-il adult li żiedu Zenapax ma' ciclosporin u prednisone esperjenzaw irrifjutar, imqabbla ma' 47 (35%) tal-134 li żiedu plaċebo.
English: Zenapax has been studied in two main studies involving a total of 535 adults undergoing kidney transplant.
Maltese: Zenapax ġie studjat f'żewġ studji ewlenin li jinvolvu total ta' 535 adult li se jsirilhom trapjant talkilwa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zenapax to Roche Registration Limited on 26 February 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Zenapax valida fl-Unjoni Ewropea kollha lil Roche Registration Limited fis-26 ta' Frar 1999.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Zenapax's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation, used concomitantly with an immunosuppressive regimen, including ciclosporin and corticosteroids in patients who are not highly immunised.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu tal-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Zenapax huma akbar mir-riskji tiegħu għall-profilassi ta' irrifjutar akut ta' organi fi trapjant renali alloġeniku de novo, meta wżat f'konkomitanza ma' reġimen immunosuppressiv, inklużi ciclosporin u kortikosterojdi f'pazjenti li mhumiex immunizzati ħafna.
English: What is Zenapax?
Maltese: Għal xiex jintuża Zenapax?
English: In the first study, the patients were receiving ciclosporin and prednisone (a corticosteroid), and in the second study, they were receiving ciclosporin, prednisone and
Maltese: Fl-ewwel studju, il-pazjenti kienu qed jirċievu ciclosporin u prednisone (kortikosterojde), u fit-tieni studju, kienu qed jirċievu ciclosporin, prednisone u azathioprine.
English: Zenapax is a concentrate to be made up into a solution for infusion (drip into a vein).
Maltese: Zenapax huwa konċentrat li jitħallat f'soluzzjoni għal infużjoni (drip ġol-vina).
English: Why has Zenapax been approved?
Maltese: Għaliex ġie approvat Zenapax?
English: For the full list of side effects reported with Zenapax, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji irrapportati b'Zenapax, ara l-Fuljett ta' Tagħrif.
English: In studies, side effects were seen at similar rates in patients taking Zenapax and those taking placebo, when given in combination with immunosuppressive medicines.
Maltese: Fl-istudji, effetti sekondarji dehru f'rati simili f'pazjenti li qed jieħdu Zenapax u dawk li qed jieħdu plaċebo, meta mogħti f'kombinazzjoni ma' mediċini immunosoppressivi.
English: Daclizumab has been designed to bind to the receptor for interleukin-2 on the surface of white blood cells called T-lymphocytes.
Maltese: F'dan l-istudju, Zenapax kien miżjud mal-mediċini immunosoppressivi diġà eżistenti tat-tfal.
English: Zenapax was more effective than placebo in reducing the rate of rejection when added to immunosuppressive therapy.
Maltese: Zenapax kien aktar effettiv minn plaċebo f'li jnaqqas ir-rata ta' irrifjutar meta miżjud ma' terapija immunosoppressiva.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li ġie iddisinnjat biex jagħraf u jorbot ma' struttura speċifika (imsejħa antiġen) li tinsab fuq ċerti ċelloli fil-ġisem.
English: By binding to and blocking the receptor, daclizumab prevents interleukin-2 activating the T-lymphocytes, reducing the chance that the transplanted kidney will be rejected.
Maltese: Fl-istudju tat-tfal, ħamsa (8%) esperjenzaw irrifjutar fl-ewwel sitt xhur wara t-trapjant.
English: What is the risk associated with Zenapax?
Maltese: X'inhu r-riskju assoċjat ma' Zenapax?
English: MedDRA system organ class (SOC)
Maltese: Sistema tal-klassifika talorgani MedDRA (SOC)
English: Contents:
Maltese: Kontenut:
English: Viral safety
Maltese: Sigurtà virali
English: ATC code: B02BD04.
Maltese: B02BD04
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, the Netherlands 12.
Maltese: U INDIRIZZ TAD-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, l-Olanda 12.
English: EU/1/01/186/001 (500 IU)
Maltese: EU/1/01/186/001
English: Contains: sodium chloride, histidine and sucrose.
Maltese: Fih: sodium chloride, histidine u sucrose.
English: EU/1/01/186/002 (1000 IU)
Maltese: EU/1/01/186/002
English: Do not use Nonafact:
Maltese: Tużax Nonafact:
English: NL-1066 CX Amsterdam The Netherlands
Maltese: NL-1066 CX Amsterdam Olanda
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 (<1/10,000), not known (cannot be estimated from the available data)
Maltese: Il-frekwenzi ġew 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 1066 CX Amsterdam The Netherlands
Maltese: 1066 CX Amsterdam L-Olanda
English: Contraindications
Maltese: Kontra-indikazzjonijiet
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Maltese: Trombin imbagħad jibdel fibrinoġen għal fibrin u hekk jifforma embolu.
English: Nonafact contains sodium chloride
Maltese: Nonafact fih sodium chloride
English: What Nonafact contains - The active substance is human coagulation factor IX.
Maltese: X'fih Nonafact - Is-sustanza attiva hi fattur IX koagulazzjoni umana.
English: Produced from the plasma of human donors.
Maltese: Magħmul mill-plażma ta' donaturi umani.
English: BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT Lot:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/186/001 EU/1/01/186/002 13.
Maltese: NUMRU(I) TA' L- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/186/001 EU/1/01/186/002 13.
English: Nonafact has a half-life of approximately 19 (17 - 21) hours.
Maltese: Nonafact għandu half-life ta' bejn wieħed u ieħor 19 (17 - 21)-il siegħa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 03 July 2001
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 03 ta' Lulju 2001
English: Prophylaxis
Maltese: Profilassi
English: • Risk Management Plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (RMP)
English: Frequency of doses (hours)/Duration of therapy (days)
Maltese: Frekwenza tad-doża (sigħat)/Tul tatterapija (jiem)
English: Bring the two vials to a temperature between 15°C and 25°C.
Maltese: Ġib it-temperatura taż-żewġ kunjetti bejn 15C u 25C.
English: Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.9
Maltese: Unitajiet meħtieġa = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur IX (%) (IU/dl) x 0.9
English: Renewal of authorisation: 03 July 2006
Maltese: Tiġdid ta' l-awtorizzazzjoni: 03 ta' Lulju 2006
English: [*For the printed material, please refer to the guidance of the annotated QRD template.]
Maltese: [*Għall-materjal stampat, jekk jogħġbok irreferi għall-gwida tal-mudell annotat tal-QRD.]
English: Store in a refrigerator (at 2°C - 8°C ).
Maltese: Aħżen fi friġġ (2C - 8C).
English: Intravenous use.
Maltese: Injetta immedjatament.
English: The safety and efficacy of Nonafact in children 0 to 6 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Nonafact għal tfal ta' età 0 sa 6 snin ma ġewx stabbiliti.
English: EXP:
Maltese: Trab:
English: Your doctor will consider whether administration of Nonafact imposes a risk for coagulation complications.
Maltese: It-tabib tiegħek jara jekk Nonafact ipoġġikx f'riskju għal komplikazzjonijiet ta' koagulazzjoni.
English: There are no known interactions between Nonafact and other medicinal products.
Maltese: Ma hemm l-ebda interazzjonijiet magħrufa bejn Nonafact u prodotti mediċinali oħra.
English: Nonafact contains trace amounts (< 0.1 ng mouse IgG/IU of factor IX) of the murine monoclonal antibody used in its purification.
Maltese: Nonafact fih ammonti żgħar ħafna (< 0.1 ng ta' IgG/IU tal-ġrieden ta' fattur IX) tal-antikorp monoklonali murine użat fil-purifikazzjoni tiegħu.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature of 21°C.
Maltese: L-istabilità kimika u fiżika waqt l-użu ġiet murija għal sa 3 sigħat f'temperatura ta' 21 C.
English: The adverse reaction flushing is reported in a clinical trial.
Maltese: Ir-reazzjoni avversa fwawar ġiet irrappurtata fi prova klinika.
English: Pharmacotherapeutic group: antihemorrhagics, blood coagulation factor IX.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, fattur IX ta' koagulazzjoni tad-demm. kodiċi ATC:
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Maltese: Hemm riskju potenzjali ta' episodji tromboemboliċi meta jingħataw prodotti ta' fattur IX, b'riskju ogħla meta dawn ikunu ta' purità baxxa.
English: For safety information with respect to transmissible agents, see 4.4.
Maltese: Għall-informazzjoni dwar is-sigurta f'dak li għandu x'jaqsam ma' aġenti trasmissibbli, ara 4.4
English: Adverse reaction (PT)
Maltese: U MANIFATTUR(I) RESPONSABBLI
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Ipersensittività jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit ta' linfużjoni, tkexkix ta' bard, fwawar, urtikarja ġenerali, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' sabar, takikardija, għafsa fis-sider, tnemnim, remettar, tħarħir) ġew osservati b'mod rari u jistgħu f' xi każijiet jistgħu jaggrwvw għal anafilassi severa (li tinkludi xokk).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini (EMA) http://www.ema.europa.eu/.
English: Hypersensitivity
Maltese: Ipersensittività
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Maltese: L-użu ta' prodotti b' fattur IX ta' purità baxxa kien assoċjat ma' każijiet ta' infart mijokardijaku, koagulazzjoni intravaskulari mifruxa, trombożi fil-vina u emboliżmu pulmonari.
English: Cardiovascular events
Maltese: Avvenimenti kardjovaskulari
English: Thrombosis
Maltese: Tromboemboliżmu
English: VIAL OF SOLVENT 5 ml VIAL OF SOLVENT 10 ml
Maltese: KUNJETT TA' SOLVENT TA' 5 ml
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Maltese: Il-Fattur X attivat jikkonverti protrombin għal trombin.
English: 500 IU: one vial (glass type I) of powder + one vial (glass type I) of 5 ml solvent with stoppers (bromobutyl).
Maltese: IU: kunjett (tip ta' ħġieġ I) ta' trab + kunjett (tip ta' ħġieġ I) ta' 5 ml solvent bit-tappijiet (bromobutyl).
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 and parvovirus B19 viruses.
Maltese: Il-miżuri mittieħda huma kkunsidrati bħala effettivi għall-virusis imgeżwrin, bħall-immunodeficiency virus uman (HIV), il-virus ta' l-epatite B (HBV) u l-virus ta' l-epatite C (HCV), u għall-virusis ta' lepatite A u l-paravirus B19 li m'humiex imgezwra.
English: Factor IX level required (%) (IU/dl)
Maltese: Livell ta' Fattur IX meħtiġ (%) (IU/dl)
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Maltese: Il-fattur IX huwa glikoproteina ta' katina waħda b'massa molekulari ta' madwar 68,000
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 viruses such as hepatitis A and parvovirus B19.
Maltese: Il-miżuri mittieħda huma kkunsidrati bħala effettivi għall-virusis imgeżwra bħall-virus talimmunodefiċjenza umana (HIV), hepatitis B virus (HBV) virus tal-epatite Ċ (HCV), u għall-virusis mhux imgeżwra bħal epatite A u parovirus B19.
English: Nonafact is presented as a powder and a solvent for solution for injection (vial of 5 ml or 10 ml)
Maltese: Nonafact huwa provdut bħala trab u solvent għal soluzzjoni għall-injezzjoni (kunjett ta' 5 ml jew 10 ml)
English: The in vivo increase in factor IX levels obtained with Nonafact is 1.1 IU/dl per IU administered per kg body weight, which corresponds to an in vivo recovery of 49 %.
Maltese: Iż-żieda fil-livelli ta' fattur IX in vivo miksuba b'Nonafact hija ta' 1.1 IU/dl għal kull IU li tingħata għal kull kg ta' piż tal-ġisem, li jikkorrispondi għal fejqan ta' 49% in vivo.
English: As with all medicinal products derived from human blood, the use of Nonafact can cause allergic reactions which may include swelling of the larynx, burning and stinging at the infusion site, chills, flushing, hives, itching and rash, headache, tiredness, nausea, restlessness, fast heartbeat, chest tightness, tingling, vomiting, wheezing.
Maltese: Bħal kull prodott mediċinali derivat mid-demm uman, l-użu ta' Nonafact jista' jikkawża reazzjonijiet allerġiċi li jistgħu jinkludu nefħa fil-larinġi, ħruq u tingiż fil-post ta' l-infużjoni, tkexkix ta' bard, fwawar, ħorriqija, ħakk u raxx, uġigħ ta' ras, għejja, dardir, nuqqas ta' sabar, taħbit mgħaġġel tal-qalb, għafsa fis-sider, tnemnim, remettar, tħarħir.
English: Solvent: Water for injections.
Maltese: Solvent: ilma għall-injezzjonijiet.
English: Powder:
Maltese: Solvent:
English: Conventional animal toxicity studies and mutagenicity studies with plasma coagulation factor IX were not carried out.
Maltese: Ma twettqux studji konvenzjonali dwar it-tossiċità fuq l-annimali u studji ta' mutaġeniċità bil-fattur IX ta' koagulazzjoni tal-plasma.
English: Other medicines and Nonafact
Maltese: Mediċini oħra u Nonafact
English: Nephrotic syndrome has been reported following attempted immune tolerance induction on haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Maltese: Sindromu nefrotiku ġie rappurtat wara attentat ta' induzzjoni ta' tolleranza immuni f'pazjenti li jbatu minn emofilja B b'inibituri ta' fattur IX u li kellhom reazzjoni allerġika fil-passat.
English: In pharmacodynamic studies in rabbits and guinea pigs, the thrombogenicity of Nonafact was shown to be minimal.
Maltese: Minn studji farmakodinamiċi fuq fniek u fuq il-fniek ta' l-Indi, irriżulta li t-tromboġeniċità ta' Nonafact hija minima.
English: If you have existing cardiovascular risk factors, substitution therapy with Factor IX may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari eżistenti, terapija ta' sostituzzjoni b'Fattur IX tista' żżid ir-riskju kardjovaskulari.
English: Factor IX is a normal constituent of human blood.
Maltese: Il-fattur IX huwa kostitwent normali taddemm uman.
English: Nonafact 100 IU/ml powder and solvent for solution for injection Human coagulation factor IX
Maltese: Nonafact 100 IU/ml trab u solvent għall-injezzjoni Fattur IX ta' koagulazzjoni umana
English: DD month YYYY
Maltese: U MNEJN GĦANDU JINGĦATA
English: Degree of haemorrhage / Type of surgical procedure
Maltese: Il-Grad ta' emorraġija/ Tip ta' proċedura kirurġika
English: Neutralising antibodies (Inhibitors)
Maltese: Antikorpi li jinnewtralizzaw (Inibituri)
English: 1000 IU: one vial (glass type I) of powder + one vial (glass type I) of 10 ml solvent with stoppers (bromobutyl).
Maltese: IU: kunjett (tip ta' ħġieġ I) ta' trab + kunjett (tip ta' ħġieġ I) ta' 10 ml solvent bit-tappijiet (bromobutyl).
English: Known allergic reaction to mouse protein.
Maltese: IU/mg proteina.
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Maltese: Wara kura ripetuta bi prodotti li fihom products ta' fattur IX tal-koagulazzjoni umana, il-pazjenti għandhom jiġu mmonitorjati għall-iżvilupp ta' antikorpi newtralizzanti (inibituri) li għandhom jiġu kkwantifikati f'Unitajiet Bethesda (BUs) billi jintuża ttestjar bijoloġiku adattat.
English: Plasma coagulation factor IX is a normal constituent of human plasma.
Maltese: Il-fattur IX ta' koagulazzjoni huwa kostitwent normali tal-plażma umana.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30 % to 60 % (IU/dl).
Maltese: Irrepeti l-infużjoni kull 8-24 siegħa sakemm il-ferita tagħlaq sewwa, wara kompli t-terapija għal millinqas 7 ijiem oħra biex iżżomm lattività ta' fattur IX ta' 30% sa 60% (IU/dl).
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Maltese: B'mod partikulari, fil-każ ta' interventi kirurġiċi maġġuri, hu indispensabbli li jsir monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal-koagulazzjoni (attività ta' fattur IX fil-plażma).
English: The use of high purity factor IX is rarely associated with such adverse reactions.
Maltese: L-użu ta' fattur IX ta' purità għolja huwa rarament assoċjat ma' dawn irreazzjonijiet avversi.
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived factor IX products.
Maltese: F'każ ta' pazjenti li jirċievu prodotti ta' fattur IX derivati mill-plażma b'mod regolari/ripetutament, għandu jiġi kkunsidrat it-tilqim adattat (epatite A u B).
English: • A vial of Nonafact containing 500 IU or 1000 IU of factor IX
Maltese: • Kunjett ta' Nonafact li fiha 500
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bioloġika/ċi attiva/i
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingћata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: For long-term prophylaxis against bleeding in patients with severe haemophilia B, the usual doses are 20 to 40 IU of factor IX per kilogram of body weight at intervals of 3 to 4 days.
Maltese: Għal profilassi kontra l-ħruġ tad-demm għal żmien twil f'pazjenti b'emofilja B serja, id-dożi tas-soltu huma ta' 20 sa 40 IU ta' fattur IX għal kull kilogramma ta' piz tal-ġisem f'intervalli ta' 3 sa 4 ijiem.