FrancophonIA/ELRC3.0 huggingface dataset:
English: • one vial of BeneFIX 250, 500, 1000, 1500, 2000 or 3000 IU powder
Maltese: • kunjett wieħed ta' trab BeneFIX 250, 500, 1000,1500, 2000 jew 3000 IU
English: • Hypersensitivity/allergic reactions
Maltese: • Sensittività eċċessiva/reazzjonijiet allerġiċi
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), 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), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hija skont is-sistema tal-klassifika tal-organi MedDRA (SOC u lLivell tat-Terminu Ppreferut).
English: The active ingredient in BeneFIX is nonacog alfa.
Maltese: Is-sustanza attiva f'BeneFIX hi nonacog alfa.
English: Children 6 to < 12
Maltese: Tfal 6 sa < 12
English: Vomiting; nausea
Maltese: Sturdament; Disġewsja
English: • Phlebitis (pain and redness of veins), flushing
Maltese: • Flebite (uġigħ u ħmura tal-vini), fwawar
English: Number of subjects Clearance (mL/h/kg)
Maltese: Numru ta' suġġetti Eliminazzjoni (mL/h/kg)
English: Children 2 to < 6
Maltese: Tfal 2 sa < 6
English: Safety analysis of 25 evaluable patients reflected a safety profile as expected.
Maltese: Analiżi tas-sigurtà ta' 25 pazjent evalwabbli rriflettiet profil tas-sigurtà kif mistenni.
English: BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Maltese: Meta rikostitwit, BeneFIX ikun fih polysorbate-80, li hu magħruf li jgħolli r-rata ta' l-estrazzjoni ta' di-(2-ethylhexyl)phthalate (DEHP) minn polyvinyl chloride (PVC).
English: Renal infarct l
Maltese: Infart talkliewi
English: The parameters estimated using the final 2-compartment model are shown in Table 2.
Maltese: Il-parametri stmati permezz tal-mudell ta' 2 kompartimenti finali huma murija fit-Tabella 2.
English: Two patients underwent surgical procedures (circumcision and port-a-catheter insertion).
Maltese: Żewġ pazjenti għamlu proċeduri kirurġiċi (ċirkonċiżjoni u inseriment ta' port-a-catheter).
English: Efficacy analysis in study 3090A1-301-WW was based on 22 evaluable paediatric subjects on prophylaxis regimen including 4 on-demand patients who shortly changed to prophylaxis.
Maltese: Analiżi tal-effikaċja fi studju 3090A1-301-WW kienet ibbażata fuq 22 suġġett pedjatriku evalwabbli fuq reġimen ta' profilassi inkluż 4 pazjenti lesti preżenti li malajr qelbu għal profilassi.
English: Tel: 1800 633 363 (toll free)
Maltese: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)
English: BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU of powder in a 10 mL vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 mL of clear, colourless solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad.
Maltese: IU, 3000 IU ta' trab f'kunjett ta' 10 mL (ħġieġ ta' tip 1) b'tapp (chlorobutyl) u siġill flip-off (aluminju) u 5 mL ta' solvent ċar u bla kulur f'siringa mimlija għal-lest (ħġieġ ta' tip 1) b'tapp-planġer (bromobutyl), għatu tat-tarf (bromobutyl) u adapter sterili talkunjett tat-tagħmir tar-rikostituzzjoni, sett sterili ta' l-infużjoni, żewġ biċċiet bl-alkoħol biex tnaddaf, stikka, u pad tal-garża.
English: In a randomized, cross-over pharmacokinetic study, BeneFIX reconstituted in 0.234% sodium chloride diluent was shown to be pharmacokinetically equivalent to the previously marketed BeneFIX (reconstituted with sterile water) in 24 previously treated patients (≥12 years) at a dose of 75 IU/kg.
Maltese: Fi studju farmakokinetiku randomizzat, cross-over, BeneFIX rikostitwit f'dilwent ta' 0.234% sodium chloride intwera li huwa farmakokinetikament ekwivalenti għall-BeneFIX ikkummerċjalizzat preċedentament (rikostitwit b'ilma sterili) f'24 pazjent ikkurati preċedentament (≥12-il sena) b'doża ta' 75 IU/kg.
English: - The active substance is nonacog alfa (recombinant coagulation factor IX).
Maltese: - Is-sustanza attiva hi nonacog alfa (fattur IX tal-koagulazzjoni rikombinanti).
English: In most of the cases, an infusion rate of up to 4 mL per minute has been used.
Maltese: Fil-maġġoranza tal-każi, intużat rata ta' infużjoni sa 4 mL kull minuta.
English: BeneFIX should be injected intravenously over several minutes.
Maltese: BeneFIX għandu jiġi injettat ġol-vina għal perijodu ta' diversi minuti.
English: 1 pre-filled syringe with 5 ml solvent 1 sterile vial adapter reconstitution device 1 sterile infusion set
Maltese: Siringa mimlija għal-lest b'5 ml solvent Adapter sterili tal-kunjett tat-tagħmir tar-rikostituzzjoni Sett sterili ta' l-infużjoni
English: Desvio Algete, Km.
Maltese: Desvio Algete, Km. 1, 28700 S.
English: = body weight (in kg) X desired factor IX increase (%) or (IU/dL)
Maltese: = piż tal-ġisem (f'kg) X żjieda ta' fattur IX mixtieqa (%) jew (IU/dL)
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Maltese: Individwalment, pazjenti jista' jkollhom rispons differenti għall-fattur IX, u juru half-lives u rkupri differenti.
English: Hypersensitivity/allergic reactions
Maltese: Sensittività eċċessiva/reazzjonijiet allerġiċi
English: • Thrombotic events (abnormal blood clots)
Maltese: • Episodji trombotiċi (emboli mhux normali tad-demm)
English: Factor IX level required (%) or (IU/dL)
Maltese: Fattur IX mixtieq (%) jew (IU/dL)
English: The only documented serious adverse event related with BeneFIX was reported from the only included PUP, who experienced hypersensitivity and inhibitor development.
Maltese: L-uniku episodju avvers serju ddokumentat relatat ma' BeneFIX ġie rrapportat mill-uniku PUP inkluż, li esperjenza sensittività eċċessiva u żvilupp tal-inibitur.
English: - The other ingredients are sucrose, glycine, L-histidine, polysorbate 80.
Maltese: - Is-sustanzi l-oħra huma sucrose, glycine, L-histidine, polysorbate 80.
English: Nonacog alfa is a purified protein that has 415 amino acids in a single chain.
Maltese: Nonacog alfa hi proteina ppurifikata li għandha 415-il amino acid f'katina waħda.
English: Mean dosage ( standard deviation) for prophylaxis was 63.7 ( 19.1) IU/kg at intervals of 3 to 7 days.
Maltese: Id-doża medja ( devjazzjoni standard) għall-profilassi kienet 63.7 (19.1)
English: Elimination half-life (h) Recovery (IU/dL per IU/kg)
Maltese: Half-life taleliminazzjoni (h) Irkupru (IU/dL għal kull IU/kg)
English: BeneFIX can be used for all age groups.
Maltese: BeneFIX jista' jintuża għal kull grupp ta' età.
English: The table lists adverse reactions reported in the clinical trials of previously treated patients and identified in postmarketing use.
Maltese: It-tabella telenka r-reazzjonijiet avversi rrapportati fil-provi kliniċi ta' pazjenti kkurati preċedentement u identifikati fl-użu ta' wara t-tqegħid fis-suq.
English: BeneFIX may be administered for long term prophylaxis against bleeding in patients with severe haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for previously treated patients (PTP) was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days.
Maltese: Fi studju kliniku għal profilassi sekondarja, id-doża medja għal pazjenti li kienu ġew ikkurati qabel (PTP) kienet ta' 40 IU/kg (medda minn 13 sa 78 IU/kg) f'intervalli ta' 3 sa 4 ijiem ta' rutina.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one mL of normal human plasma.
Maltese: Unità Internazzjonali waħda (IU) tal-attività tal-fattur IX hija ekwivalenti għall-kwantità ta' fattur IX f'millilitru tal-plażma ta' bniedem normali.
English: Reconstitution:
Maltese: Maġġuri:
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Maltese: Ma ġiet irrapportata ebda interazzjoni ta' prodotti tal-fattur IX tal-koagulazzjoni fil-bniedem (rDNA) ma' prodotti mediċinali oħrajn.
English: How to store BeneFIX
Maltese: X'fih BeneFIX
English: Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor IX; ATC code: B02BD04
Maltese: Fattur IX tal-koagulazzjoni tad-demm kontra l-emorraġiji; Kodiċi ATC:
English: BeneFIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU nonacog alfa (recombinant coagulation factor IX).
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett nominalment fih 3000 IU ta' nonacog alfa (fattur IX tal-koagulazzjoni rikombinanti).
English: The terminal phase has not been covered unambiguously due to lack of data beyond 24 hours in paediatric subjects < 6 years of age.
Maltese: Il-fażi terminali ma ġietx koperta b'mod mhux ambigwu minħabba nuqqas ta' dejta lil hinn minn 24 siegħa f'suġġetti pedjatriċi < 6 snin.
English: BeneFIX contains recombinant coagulation factor IX, (nonacog alfa).
Maltese: BeneFIX fih il-fattur IX, (Nonacog alfa) tal-koagulazzjoni rikombinanti.
English: 1 vial: 3000 IU nonacog alfa (approx. 600 IU/ml after reconstitution).
Maltese: kunjett 1: 3000 IU nonacog alfa (madwar 600
English: Potentially life-threatening anaphylactic/anaphylactoid reactions have occurred with factor IX products, including BeneFIX.
Maltese: Reazzjonijiet anafilattiċi/anafilattojdi li huma ta' theddida għall-ħajja dehru bi prodotti tal-fattur IX, inkluż BeneFIX.
English: 2 alcohol swabs 1 plaster 1 gauze pad
Maltese: 2 biċċiet bl-alkoħol Stikka waħda Pad wieħed tal-garża
English: There are insufficient data to provide information on inhibitor incidence in PUPs (see also section 5.1).
Maltese: Ma hemmx dejta biżżejjed sabiex tkun tista' tiġi pprovduta informazzjoni dwar l-inċidenza ta' inibitur f'PUPs (ara wkoll is-sezzjoni 5.1).
English: Record of use
Maltese: Rekord tal-użu
English: • Rash, hives
Maltese: • Raxx, ħorriqija
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Maltese: Dan huwa ta' importanza partikolarment meta ssir bidla tal-laboratorju u/jew tar-reaġenti użati fl-assay.
English: BeneFIX may increase the risk of thrombosis (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter.
Maltese: BeneFIX jista' jżid ir-riskju ta' trombożi (emboli anormali) f'ġismek jekk għandek fatturi ta' riskju li tiżviluppa emboli, li jinkludu kateter venuż indwelling.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Thrombin imbagħad jibdel il-fibrogen f'fibrin u jista' jifforma embolu.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: L-emofilja B hi marda ereditarja tal-koagulazzjoni tad-demm minħabba livelli mnaqqsa ta' fattur IX u tirriżulta fi fsada fil-ġogi, fil-muskoli u fl-organi interni, li tkun spontaneja jew bħala riżultat ta' trawma aċċidentali jew kirurġika.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu kienet murija għal 3 sigħat f'temperaturi sa 25ºC.
English: Recombinant coagulation factor IX is a glycoprotein that is secreted by genetically engineered mammalian cells derived from a Chinese hamster ovary (CHO) cell line.
Maltese: Il-fattur IX rikombinanti tal-koagulazzjoni huwa glikoproteina, miksub permezz ta' l-inġinerija ġenetika ta' ċelluli mammiferi derivat mir-razza ta' ċelluli ta' l-ovarji ta' ħamster ċiniż (CHO).
English: Phlebitis; flushing g
Maltese: Flebite; fwawar
English: Frequency of doses (hours)/Duration of Therapy (days)
Maltese: Frekwenza ta' dożi (siegħat)/Tul tatTerapija (ġranet)
English: Every 24 hours, at least 1 day, until healing is achieved.
Maltese: Kull 24 siegħa, mill-anqas għal ġurnata, sakemm tfiq.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Maltese: Sindrome nefrotiku kien rappurtat wara prova ta' żvilupp ta' tolleranza immuni f'pazjenti bl-emofilija B b'impedituri ta' fattur IX li kellhom reazzjoni allerġika fil-passat.
English: Number of factor IX IU required
Maltese: Numru ta' IU ta' fattur IX meħtieġa
English: The safety and efficacy of BeneFIX administration by continuous infusion have not been established (see also sections 4.2 and 4.8).
Maltese: Is-sigurtà u l-effikaċja tal-għoti ta' BeneFIX permezz ta' infużjoni kontinwa ma kinux stabbiliti (ara wkoll sezzjonijiet 4.2 u 4.8).
English: BeneFIX contains recombinant coagulation factor IX, (INN = nonacog alfa).
Maltese: BeneFIX fih il-fattur IX rikombinanti tal-koagulazzjoni, (INN = nonacog alfa).
English: BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile 0.234% sodium chloride solution (see section 6.6).
Maltese: 234% sodium chloride sterilizzat (ara sezzjoni 6.6).
English: • Sleepiness, shaking
Maltese: • Rimettar, dardir
English: Peel back the lid from the clear plastic vial adapter package.
Maltese: Qaxxar lura l-għatu mill-pakkett ta' l-adapter tal-kunjett tal-plastik ċar.
English: • two alcohol swabs
Maltese: • żewġ biċċiet bl-alkoħol
English: Parameter
Maltese: Impedituri
English: • Renal infarct (interruption to the blood supply to the kidney)
Maltese: • Infart renali (interruzzjoni tal-provvista tad-demm lejn il-kliewi)
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: Fil-każ ta' interventi kirurġiċi maġġuri b'mod partikolari, monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi ta' koagulazzjoni (attività tal-fattur IX filplażma) huwa indispensabbli.
English: As one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor during clinical studies and experience on antigenicity with recombinant factor IX is still limited, patients treated with BeneFIX should be carefully monitored for the development of factor IX inhibitors that should be titrated in Bethesda Units using appropriate biological testing.
Maltese: Billi pazjent PTP wieħed li kien qed jieħu BeneFIX żviluppa impeditur klinikament relevanti ta rispons baxx u l-esperjenza dwar l-antiġeniċità mal-fattur IX rikombinanti għadha ristretta, il-pazjenti li jiġu kkurati b'BeneFIX għandhom ikunu sorveljati b'attenzjoni għall-iżvilupp ta' impedituri tal-fattur IX li għandhom ikunu ttitrati f'Unitajiet Bethesda permezz ta' ttestjar bijoloġiku xieraq.
English: • one gauze pad
Maltese: • pad wieħed tal-garża
English: It has a primary amino acid sequence that is comparable to the Ala allelic form of plasma-derived factor IX, and some post-translational modifications of the recombinant molecule are different from those of the plasma-derived molecule.
Maltese: Għandha sekwenza primarja ta' amino acids li tista' tqabbilha ma' l-għamla allelika Ala148 tal-fattur IX derivat mill-plażma, u xi modifiki ta' wara t-translazzjonali tal-molekula rikombinanti huma differenti minn dawk tal-molekula li hi derivata mill-plażma.
English: Visual impairment e
Maltese: Indeboliment tal-vista
English: m including injection site pain, infusion-site discomfort n including infusion-site pruritus, infusion-site erythema o including chest pain and chest tightness p
Maltese: fsada. inklużi uġigħ fis-sit tal-injezzjoni, skumdità fis-sit tal-infużjoni inklużi prurite fis-sit tal-infużjoni, eritema fis-sit tal-infużjoni inklużi uġigħ fis-sider u għafis fuq is-sider Dan huwa terminu verbatim.
English: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Maltese: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
English: Factor IX inhibition b
Maltese: Inibizzjoni talfattur IX
English: Lot See front label (Lot, Exp.)
Maltese: Ara t-tikketta ta' quddiem (Lott, JIS)
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 jinkiseb fejqan adegwat talferita, imbagħad t-terapija titkompla għal mill-anqas 7 ijiem oħra sabiex tinżamm l-attività tal-fattur IX ta' 30% sa' 60% (IU/dL)
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IU/dL, il-formula taqra:
English: Allergic-type hypersensitivity reactions are possible with BeneFIX.
Maltese: Reazzjonijiet ta' sensittività eċċessiva ta' tip allerġiku huma possibbli b'BeneFIX.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data)
Maltese: Effetti sekondarji bi frekwenza mhix magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: A population pharmacokinetic model was developed using data collected in 73 patients aged 7 months to 60 years.
Maltese: Mudell tal-farmakokinetika ta' popolazzjoni ġie żviluppat permezz ta' dejta miġbura fi 73 pazjent ta' bejn is-7 xhur u s-60 sena.
English: Cough j
Maltese: U L-UŻU
English: Potentially life-threatening anaphylactic reactions (severe allergic reactions) have occurred with factor IX products, including BeneFIX.
Maltese: Reazzjonijiet anafilattiċi li jistgħu jkunu ta' theddida għall-ħajja (reazzjonijiet allerġiċi severi) dehru bi prodotti tal-fattur IX, inkluż BeneFIX.
English: Infants
Maltese: Emorraġija
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Maltese: Minħabba r-riskju ta' kumplikazzjonijiet trombotiċi, huwa mportanti li jsir monitoraġġ kliniku għal sinjali bikrija tal-koagulopatija trombotika u konsumattiva u għandha ssir eżaminazzjoni bijoloġika xierqa meta jingħata dan il-prodott lil pazjenti b'mard tal-fwied, pazjenti wara li jkunu għamlu xi operazzjoni, trabi tat-twelid, jew pazjenti li qiegħdin f'riskju ta' fenomeni trombotiċi jew DIC.
English: • one pre-filled syringe of solvent, 5 ml sterile 0.234% sodium chloride solution for injection for reconstitution, with one plunger rod
Maltese: 234% sodium chloride soluzzjoni sterili għall injezzjoni għar-rikostituzzjoni, b'lasta tal-planġer waħda
English: In case of severe allergic reactions, alternative therapy should be considered.
Maltese: Fil-każ ta' reazzjonijiet ta' allerġija serja, terapija alternattiva għandha tkun ikkunsidrata.
English: Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Maltese: Studji kliniċi fuq BeneFIX ma kinux inkludew numru suffiċjenti ta' pazjenti minn 65 sena 'l fuq biex ikun determinat jekk jirrispondux b'mod differenti minn pazjenti iżgħar.
English: - Allergic reactions are possible.
Maltese: - Reazzjonijiet allerġiċi huma possibbli.
English: There is limited documentation of on-demand treatment and surgery in paediatric patients less than 6 years of age treated with BeneFIX.
Maltese: Ftit hemm dokumentazzjoni ta' kura u kirurġija dak il-ħin f'pazjenti pedjatriċi li għandhom inqas minn 6 snin ikkurati b'BeneFIX.
English: There have been post-marketing reports of thrombotic events, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion BeneFIX through a central venous catheter (see also section 4.8).
Maltese: Kien hemm rapporti ta' avvenimenti trombotiċi wara li l-prodott beda jinbiegħ, li kienu jinkludu sindrome tal-vena cava superjuri (SVC) li kienu ta' periklu għall-ħajja fi trabi tat-twelid morda b'mod kritiku, waqt li l-pazjent kien qed jirċievi infużjoni kontinwa ta' BeneFIX minn ġo kateter venuż ċentrali (ara wkoll sezzjoni 4.8).
English: How to take BeneFIX
Maltese: Tiħux BeneFIX
English: Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.
Maltese: L-attività tal-fattur IX hi assenti jew imnaqqsa sew f'pazjenti bl-emofilja B u jista' jkun hemm bżonn terapija ta' sostituzzjoni.
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 and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Ġiet osservata sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedema, ħruq u tingiż fis-sit tal-infużjoni, tertir, ħmura fil-wiċċ, urtikarja ġeneralizzata, uġigħ ta' ras, urtikarja, pressjoni baxxa, letarġija, dardir, irrikwetezza, takikardja, għafis fis-sider, tagħrix, rimettar, tħarħir) u f'xi każijiet jistgħu javvanzaw għal anafilassi severa (inkluż xokk).
English: If any suspected hypersensitivity reaction takes place that is thought to be related to the administration of BeneFIX see sections 4.2 and 4.4.
Maltese: Jekk isseħħ xi reazzjoni ta' sensittività eċċessiva ssuspettata li hija maħsuba li hija relatata mal-għoti ta' BeneFIX, ara sezzjonijiet 4.2 u 4.4.
English: - If you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6).
Maltese: - Jekk inti allerġiku għal nonacog alfa jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Maltese: Pazjenti b'emofilja B jistgħu jiżviluppaw anti-korpi newtralizzanti (impedituri) għall-fattur IX.
English: • Anaphylactic reaction
Maltese: • Reazzjoni anafilattika
English: infusion-site reaction n; infusion-site pain m
Maltese: IU/dL) f'pazjenti  12-il sena (aktar informazzjoni fis-sezzjoni
English: Headache d
Maltese: ANNESS I
English: Remove the plastic flip-top cap from the BeneFIX vial to expose the central portion of the rubber stopper.
Maltese: Neħħi l-għatu flip-top tal-plastik mill-kunjett ta' BeneFIX biex tikxef il-parti ċentrali tat-tapp tal-lastku.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa.
Maltese: 234%) sodium chloride li hi pprovduta miegħu, kull 1 mL ta' soluzzjoni jkun fih madwar 300 IU nonacog alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 400 IU nonacog alfa.
Maltese: 234%) sodium chloride li hi pprovduta miegħu, kull 1 mL ta' soluzzjoni jkun fih madwar 400 IU nonacog alfa.
English: A solvent (0.234% sodium chloride solution) is also supplied for reconstitution.
Maltese: 234% sodium chloride) hi fornuta wkoll għar-rikostituzzjoni.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 5 ml of 0.234% sodium chloride solution for injection
Maltese: 234% sodium chloride soluzzjoni għall-injezzjoni
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Maltese: Jekk jidhru dawn l-impedituri, il-kondizzjoni tista' tintwera bħala rispons kliniku mhux suffiċjenti.
English: Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TALUŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI