FrancophonIA/ELRC3.0 huggingface dataset:
English: • The other ingredients in the powder are sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide and hydrochloric acid.
Maltese: • Is-sustanzi l-oħra fit-trab huma sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide u hydrochloric acid.
English: Table 2 Treatment in surgery with Refixia
Maltese: Tabella 2 Kura f'każ ta' kirurġija b'Refixia
English: In children aged 0-12 years, the median (IQR) annualised bleeding rate was 1.0 (0.00; 2.06) and the spontaneous bleeding rate was 0.00 (0.00; 0.00).
Maltese: Fi tfal li kellhom minn 0-12-il sena, il-medjan (IQR) tar-rata annwalizzata ta' fsada kien ta' 1.0 (0.00; 2.06), u r-rata ta' fsada spontanja kienet ta' 0.00 (0.00; 0.00).
English: Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) selectively attached to specific N-linked glycans in the rFIX activation peptide.
Maltese: Refixia hu fattur IX uman rikombinanti (rFIX) ippurifikat b'40 kDa polyethylene-glycol (PEG) imwaħħal b'mod selettiv ma' N-linked glycans speċifiċi fil-peptide ta' attivazzjoni ta' rFIX.
English: • chest tightness
Maltese: taħt il-ġilda
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota li l-ABR mhijiex komparabbli bejn konċentrati differenti ta' fattur u bejn studji kliniċi differenti.
English: In case of residual FIX activity levels, there is a risk of interference when performing the Nijmegen modified Bethesda assay for inhibitor testing.
Maltese: F'każ ta' livelli residwi ta' attività ta' FIX, hemm riskju ta' interferenza meta jsir l-assaġġ Bethesda mmodifikat ta' Nijmegen għall-ittestjar tal-inibitur.
English: The overall success rate for treatment of breakthrough bleeds was 97.1% (67 out of 69 evaluated bleeds).
Maltese: Ir-rata globali ta' suċċess għall-kura taliżvilupp ta' fsada, kienet ta' 97.1% (67 minn 69 episodju ta' fsada evalwati).
English: Histidine solution
Maltese: Soluzzjoni ta' histidine
English: The overall success rate (defined as excellent or good) for treatment of bleeds was 93% (551 out of 591).
Maltese: Ir-rata globali ta' suċċess (definita bħala eċċellenti jew tajba) għall-kura tal-fsada kienet ta' 93% (551 minn 591).
English: (bromobutyl) and a tip cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
Maltese: (polypropylene), planġer tal-gomma (bromobutyl) u tarf li jingħalaq b'tapp (bromobutyl) - lasta tal-planġer waħda (polypropylene).
English: Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid
Maltese: Histidine, ilma għall-injezzjonijiet, sodium hydroxide, hydrochloric acid
English: Refixia has a prolonged half-life compared to unmodified factor IX.
Maltese: Refixia għandu half-life imtawla meta mqabbel ma' fattur IX mhux immodifikat.
English: Haemostatic effect of Refixia during surgery was confirmed with a success rate of 100% in the 15 major surgeries in the trials.
Maltese: Effett emostatiku ta' Refixia waqt il-kirurġija ġie kkonfermat b'rata ta' suċċess ta' 100% fil15-il kirurġija maġġuri fil-provi.
English: Each vial of Refixia contains nominally 500 IU, 1000 IU or 2000 IU nonacog beta pegol corresponding to approximately 125 IU/ml, 250 IU/ml or 500 IU/ml respectively after reconstitution with histidine solvent.
Maltese: IU nonacog beta pegol, li jikkorrispondu għal madwar 125 IU/mL, 250 IU/mL jew 500
English: Overall haemostatic efficacy
Maltese: Effikaċja emostatika globali
English: 2000 IU powder in a vial and 4 ml solvent in a pre-filled syringe, a plunger rod with a vial adapter - pack size of 1).
Maltese: IU ta' trab f'kunjett u 4 mL ta' solvent f'siringa mimlija għal-lest, lasta tal-planġer b'adapter tal-kunjett - daqs tal-pakkett ta' 1).
English: Pre-operative dose.
Maltese: Kirurġija maġġuri.
English: • you have recently had surgery
Maltese: • riċentement kellek intervent kirurġiku
English: After reconstitution, 1 ml of Refixia contains approximately 125 IU nonacog beta pegol.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' Refixia jkun fih madwar 125 IU ta' nonacog beta pegol.
English: Clearance (CL) (ml/hour/kg) Mean residence time (MRT) (hours)
Maltese: (17) Ħin medju ta' residenza (MRT, Mean residence time) (sigħat)
English: In this pivotal trial in adolescent and adult patients, there were 70 breakthrough bleeding episodes for 16 out of 29 patients in the 40 IU/kg prophylaxis arm.
Maltese: F'din il-prova pivitali f'pazjenti adolexxenti u adulti, kien hemm 70 episodju ta' żvilupp ta' fsada għal 16 mid-29 pazjent fil-fergħa ta' profilassi b'40 IU/kg.
English: Half-life (t1/2) (hours) Incremental Recovery (IR) (IU/ml per IU/kg)
Maltese: Irkupru Inkrementali (IR, Incremental Recovery) (IU/ml kull IU/kg)
English: Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Maltese: Il-pakkett fih: kunjett wieħed ta' trab, 4 ml ta' solvent f'siringa mimlija għal-lest, lasta tal-planġer u adapter tal-kunjett
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Maltese: IU ta' nonacog beta pegol (madwar 125 IU/mL wara r-rikostituzzjoni),
English: Table 6 Mean of trough levels* of Refixia (40 IU/kg) at steady state
Maltese: Tabella 6 Medja ta' livelli minimi* ta' Refixia (40
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Maltese: Thrombin imbagħad jibdel fibrinogen f'fibrin u jiġi ffurmat tagħqid tad demm.
English: The powder is white to off-white.
Maltese: It-trab hu ta' kulur abjad sa off-white.
English: Common Uncommon Common
Maltese: Mhux komuni Komuni
English: Upon activation of Refixia, the activation peptide including the 40 kDa polyethylene-glycol moiety is cleaved off, leaving the native activated factor IX molecule.
Maltese: Wara lattivazzjoni ta' Refixia, il-peptide ta' attivazzjoni inkluż il-parti tal-polyethylene-glycol 40 kDa tinqata' u b'hekk tibqa' l-molekula attivata nattiva ta' fattur IX.
English: Injection site reactions**
Maltese: Reazzjonijiet fis-sit talinjezzjoni**
English: * Factor IX trough levels = factor IX activity measured prior to next weekly dose (5 to 10 days post dosing) at steady state.
Maltese: * Livelli minimi ta' fattur IX = attività ta' fattur IX imkejla qabel id-doża ta' kull ġimgħa li jkun imiss (5 sa 10 ijiem wara l għoti tad-doża) fl-istat fiss.
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).
Maltese: Kura u profilassi għall-fsada f'pazjenti minn 12-il sena 'l fuq b'emofilja B (defiċjenza konġenitali talfattur IX).
English: Refixia contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri huwa essenzjalment “ħieles mis-sodium”.
English: Table 5 Single-dose pharmacokinetic parameters of Refixia (40 IU/kg) by age (geometric mean (CV%))
Maltese: Tabella 4 Parametri farmakokinetiċi fl-istat fiss ta' Refixia (40
English: When comparing the 10 IU/kg and 40 IU/kg treatments, the annualised bleeding rate for patients in the 40 IU/kg arm was found to be 49% lower than the bleeding rate (95% CI: 5%;73%) for patients in the 10 IU/kg arm (p<0.05).
Maltese: Meta ġiet imqabbla l-kura b'10 IU/kg ma' 40 IU/kg, ir-rata annwalizzata ta' fsada għall-pazjenti fil-fergħa ta' 40 IU/kg instabet li kienet 49% inqas mir-rata ta' fsada (95% CI) għallpazjenti fil-fergħa ta' 10 IU/kg (p <0.05).
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: Ġie rappurtat sindromu nefrotiku wara prova ta' induzzjoni ta' tolleranza immuni f'pazjenti b'emofilja B b'inibituri ta' fattur IX u storja ta' reazzjoni allerġika.
English: The solvent is a histidine solution.
Maltese: Is-solvent huwa soluzzjoni ta' histidine.
English: Allergic reactions and development of inhibitors There is a rare risk that you may experience a sudden and severe allergic reaction (e.g. anaphylactic reaction) to Refixia.
Maltese: Reazzjonijiet allerġiċi u l-iżvilupp ta' inibituri Hemm riskju rari li inti jista' jkollok reazzjoni allerġika f'daqqa u severa (eż. reazzjoni anafilattika)
English: Based on modelled data using observed terminal half-lives (1549 days) in rat tissue distribution studies, the 40 kDa polyethylene-glycol (PEG) moiety will reach steady state levels in all human tissues within 1-2 years of treatment.
Maltese: Skont tagħrif magħmul fuq mudelli bl-użu ta' half-lives terminali (15-49 ġurnata) osservati f'studji ta' distribuzzjoni fit-tessuti tal-far, il-parti 40 kDa polyethylene-glycol (PEG) tilħaq livelli ta' stat fiss fit-tessuti umani kollha fi żmien sena sa sentejn ta'
English: Due to the interference of polyethylene glycol (PEG) in the one-stage clotting assay with various aPTT reagents, it is recommended to use a chromogenic assay (e.g. Rox Factor IX or Biophen) when monitoring is needed.
Maltese: Minħabba l-interferenza ta' polyethylene glycol (PEG) fl-assaġġ ta' tagħqid tad-demm fi stadju wieħed ma' diversi reaġenti ta' aPTT, hu rakkomandat l-użu ta' assaġġ kromoġeniku (eż. Rox Factor IX jew Biophen) meta jkun meħtieġ il-monitoraġġ.
English: Stop the injection and contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, shortness of breath, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, and/or dizziness.
Maltese: Waqqaf l-injezzjoni u kkuntattja lit-tabib tiegħek jew dipartiment tal-emerġenza immedjatament jekk ikollok sinjali ta' reazzjoni allerġika bħal raxx, ħorriqija, feriti, ħakk fuq żoni kbar tal-ġilda, ħmura u/jew nefħa fix-xofftejn, fl-ilsien, fil-wiċċ jew fl-idejn, tbatija biex tibla' jew tieħu n-nifs, qtugħ ta' nifs, tħarħir, tagħfis tas-sider, ġilda pallida u kiesħa, qalb tħabbat b'rata mgħaġġla, u/jew sturdament.
English: Each pack contains: - 1 glass vial (type I) with powder and chlorobutyl rubber stopper - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 ml histidine solvent with backstop (polypropylene), a rubber plunger
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kull pakkett fih: - kunjett wieħed tal-ħġieġ (tip I) bi trab u tapp tal-gomma chlorobutyl - adapter wieħed sterili għall-kunjett għar-rikostituzzjoni - siringa waħda mimlija għal-lest b'4 ml ta' solvent ta' histidine b'ilqugħ fuq wara
English: Minor surgery including tooth extraction.
Maltese: Kirurġija minuri inkluż qlugħ ta'
English: All pharmacokinetic studies with Refixia were conducted in previously treated patients with haemophilia B (factor IX ≤2%).
Maltese: L-istudji farmakokinetiċi kollha b'Refixia saru f'pazjenti b'emofilja B li kienu ħadu kura qabel (fattur IX ≤2%).
English: • Take out the number of Refixia packages you need.
Maltese: • Oħroġ in-numru ta' pakketti Refixia li għandek bżonn.
English: A pre-operative dose of 80 IU/kg Refixia was effective and no patients required additional doses on the day of surgery.
Maltese: Id-doża ta' 80 IU/kg ta' Refixia qabel il-kirurġija kienet effettiva u l-ebda pazjent ma kien jeħtieġ dożi addizzjonali fil-jum tal-kirurġija.
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 hija disturb ereditarju ta' tagħqid tad-demm marbut mas-sess tal-persuna minħabba livelli mnaqqsa ta' fattur IX u twassal għal fsada kbira fil-ġogi, fil-muskoli, jew fl-organi interni, b'mod spontanju jew inkella minħabba trawma aċċidentali jew kirurġika.
English: Pivotal trial
Maltese: Prova pivitali
English: The patients received 1 pre-operative injection of 80 IU/kg on the day of surgery, and post-operatively, injections of 40 IU/kg.
Maltese: Il-pazjenti rċivew injezzjoni waħda ta' 80 IU/kg qabel l-operazzjoni fil-jum tal-kirurġija, u injezzjonijiet ta' 40 IU/kg wara lkirurġija.
English: Store the reconstituted product in the vial.
Maltese: Refixia huwa fornut bħala trab.
English: In a dedicated surgery trial, the efficacy analysis included 13 major surgical procedures performed in 13 previously treated adult and adolescent patients.
Maltese: Fi prova ddedikata għal kirurġija l- analiżi tal-effikaċja kienet tinkludi 13-il proċedura kirurġika maġġuri mwettqa fi 13-il pazjent adult u adolexxenti li kienu kkurati qabel.
English: There is a rare risk of developing a specific kidney disorder called “nephrotic syndrome” following high doses of factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Maltese: Hemm riskju rari li jiżviluppa disturb speċifiku fil-kliewi msejjaħ “sindromu nefrotiku” wara dożi għolja ta' fattur IX f'pazjenti b'emofilja B b'inibituri ta' fattur IX u storja ta' reazzjonijiet allerġiċi.
English: • 1 vial with Refixia powder
Maltese: • kunjett wieħed bit-trab Refixia
English: In repeat dose toxicity studies in rats and monkeys, 40 kDa polyethylene-glycol (PEG) was detected by immunohistochemical staining in epithelial cells of choroid plexus in the brain.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti fil-firien u fix-xadini, instab 40 kDa polyethyleneglycol (PEG) permezz ta' għoti ta' kulur immunoistokimiku f'ċelluli tal-epitelju tal-choroid plexus fil moħħ.
English: Consider two repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after surgery.
Maltese: IU/kg (f'intervalli ta' 1-3 ijiem) fl ewwel ġimgħa wara l-kirurġija.
English: During the shelf life Refixia may be stored up to 30°C for a single period not exceeding 6 months.
Maltese: Waqt il-perjodu qabel jiskadi, Refixia jista' jinħażen f'temperatura sa 30°C għal perjodu wieħed li ma jaqbiżx 6 xhur.
English: Steady state pharmacokinetic parameters for adolescents and adults are shown in Table 4
Maltese: Il-parametri farmakokinetiċi fl-istat fiss għall-adolexxenti u l-adulti qed jintwerew f'Tabella 4.
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Maltese: (rDNA) u prodotti mediċinali oħra.
English: BATCH NUMBER
Maltese: Tapp tassiringa
English: After repeated treatment with human coagulation factor IX (rDNA) 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 tal-fattur IX ta' koagulazzjoni umana (rDNA), il-pazjenti għandhom jiġu mmonitorjati għall-iżvilupp ta' antikorpi li jinnewtralizzaw (inibituri) li għandhom jiġu kkwantifikati f'Unitajiet Bethesda (BU - Betsada Units) bl-użu ta' ttestjar bijoloġiku xieraq.
English: Remove the protective cap from the vial adapter.
Maltese: Neħħi l-għatu protettiv mill-adapter tal kunjett.
English: Excipient with known effect Less than 1 mmol sodium (23 mg) per vial.
Maltese: Anqas minn 1 mmol ta' sodium (23 mg) f'kull kunjett.
English: By replacement therapy the plasma levels of factor IX are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Maltese: Permezz ta' terapija ta' sostituzzjoni l-livelli tal-fattur IX fil-plażma jiżdiedu, b'hekk issir possibbli korrezzjoni temporanja tad-defiċjenza fil-fattur u korrezzjoni tat-tendenzi għall-fsada.
English: NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni nonacog beta pegol (fattur IX rikombinanti ta' koagulazzjoni)
English: Non-interventional post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study deriving from a registry of Haemophilia patients according to an agreed protocol.
Maltese: Sabiex jiġu investigati l-effetti li jista' jkun hemm minħabba l-akkumulazzjoni ta' PEG filchoroid plexus tal-moħħ u tessuti/organi oħra, l-MAH għandu jagħmel u jissottometti r-riżultati ta' tudju mhux intervenzjonali dwar is-sigurta wara lawtorizzazzjoni li jkun sar minn reġistru ta' pazjenti bl-Emofilja skont protokoll miftiehem.
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Maltese: • Meta tinjetta f'CVAD jista' jkollok bżonn tuża siringa sterili tal-plastik ta' 10 mL biex tiġbed is-soluzzjoni rrikostitwita.
English: Table 4 Steady state pharmacokinetic parameters of Refixia (40 IU/kg) in adolescents and adults (geometric mean (CV%)) PK Parameter
Maltese: IU/kg) f'pazjenti pedjatriċi, adolexxenti u adulti skont l-età (medja ġeometrika (CV))
English: A trial including 25 paediatric previously treated patients (ages 0-12 years) who received a prophylactic dose 40 IU/kg once weekly was performed.
Maltese: Saret prova li kienet tinkludu 25 pazjent pedjatriku kkurati preċedentement (etajiet 0-12-il sena) li rċevew doża profilattika ta' 40 UI/kg darba fil-ġimgħa.
English: Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds or 80 IU/kg for severe bleeds, where one bleed was evaluated as severe.
Maltese: IU/kg għal fsada ħafifa jew moderata, jew bi 80 IU/kg għal fsada severa, fejn episodju wieħed ta' fsada ġie evalwat bħala sever.
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari diġà eżistenti, terapija ta' sostituzzjoni b'FIX tista' żżid ir-riskju kardjovaskulari.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Maltese: Kien hemm rapporti fil-letteratura li juru korrelazzjoni bejn l-okkorrenza ta' impeditur ta' fattur IX u reazzjonijiet allerġiċi.
English: Keep reconstituted Refixia solution out of direct light.
Maltese: Tesponix is-soluzzjoni rrikostitwita ta' Refixia għal dawl dirett.
English: In the pivotal trial there was a non-randomised arm where 15 patients were treated in an on-demand regimen with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds.
Maltese: Fil-prova pivitali, kien hemm fergħa tal-istudju fejn 15-il pazjent li ma ntagħżlux b'mod arbitrarju ġew ikkurati bi skeda ta' kura skont il-bżonn b'40 IU/kg għal fsada ħafifa jew moderata u 80 IU/kg għal fsada severa.
English: How to store Refixia
Maltese: X'fih Refixia
English: You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters.
Maltese: Se jkollok bżonn ukoll sett tal-infużjoni (pajp irqiq u labra butterfly), mselħiet sterili bl-alkoħol, gareż u stikk.
English: • hot flush.
Maltese: Aħżen fi friġġ.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),
Maltese: IU ta' nonacog beta pegol (madwar 250 IU/mL wara r-rikostituzzjoni),
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: Tromboemboliżmu Minħabba r-riskju potenzjali ta' kumplikazzjonijiet trombotiċi, għandha tinbeda sorveljanza klinika għal sintomi bikrin ta' koagulopatija trombotika u li tikkonsma b'ittestjar bijoloġiku xieraq meta wieħed jagħti dan il-prodott lill-pazjenti b'mard tal-fwied, lill-pazjenti wara operazzjonijiet, lit-trabi tat-twelid, jew lill-pazjenti li qegħdin f'riskju ta' fenomeni trombotiċi jew DIC.
English: The rate of administration should be determined by the patient's comfort level up to a maximum injection rate of 4 ml/min.
Maltese: Ir-rata tal-għoti għandha tiġi stabbilita skont il-livell ta' kumidità tal-pazjent sa rata massima ta' injezzjoni ta' 4 ml/min.
English: Clearance CL (ml/hour/kg)
Maltese: Tneħħija (CL, Clearance) (ml/siegħa/kg) 0.4
English: Attach the vial adapter
Maltese: Adapter tal-kunjett
English: Clearance = body weight adjusted clearance; Incremental recovery = incremental recovery 30 min post dosing, Volume of distribution = body weight adjusted volume of distribution at steady state.
Maltese: Tneħħija = tneħħija aġġustata skont il-piż tal-ġisem; Irkupru inkrementali = Irkupru inkrementali 30 minuta wara l-għoti taddoża, Volum ta' distribuzzjoni = volum ta' distribuzzjoni fl-istat fiss aġġustat skont il-piż tal-ġisem.
English: More extensive haemarthrosis, muscle bleeding or haematoma.
Maltese: trombożi venuża u emboliżmu pulmonari.
English: • you have risk factors for heart disease e.g high blood pressure, obesity, or smoking.
Maltese: • għandek fatturi ta' riskju għal mard tal-qalb, eż. pressjoni tad-demm għolja, obeżità, jew tpejjep.
English: Plunger rod
Maltese: Ż-ŻGĦAR EWLENIN
English: These body tremors were seen at doses of Refixia (3,750 IU/kg), which were more than 90 times higher than the recommended dose for humans (40 IU/kg).
Maltese: Refixia (3,750 UI/kg), li kienu aktar minn 90 darba ogħla mid-doża rrakkomandata għall-umani
English: • The ingredients in the sterilised solvent are histidine, water for injections, sodium hydroxide and hydrochloric acid.
Maltese: • Is-sustanzi fis-solvent sterilizzat huma histidine, ilma għall-injezzjonijiet, sodium hydroxide u hydrochloric acid.
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Maltese: Segwi l-istruzzjonijiet għall-użu xieraq tal konnettur tiegħek u tas-CVAD, b'konsultazzjoni mat-tabib u mal-infermier tiegħek.
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 jibdel prothrombin fi thrombin.
English: Hypersensitivity Anaphylaxis Inhibitors
Maltese: sensittività eċċessiva marbuta miegħu.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Maltese: Jekk ikun hemm bżonn ta' apparat li jagħti aċċess għall-vina ċentrali (CVAD, central venous access device), wieħed irid joqgħod attent għar-riskju ta' kumplikazzjonijiet marbuta ma' CVAD li jinkludu infezzjonijiet lokali, batterimja u trombożi fis-sit tal-kateter.
English: • If the CVAD line needs to be flushed before or after Refixia injection, use sodium chloride 9 mg/ml solution for injection.
Maltese: • Jekk il-pajp tas-CVAD ikollu bżonn jitlaħlaħ qabel jew wara l-injezzjoni ta' Refixia, uża soluzzjoni għall-injezzjoni ta' 9 mg/ml sodium chloride.
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: Il-pazjenti għandhom jiġu infurmati bis-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva inkluż ħorriqija, urtikarja mifruxa, tagħfis fis-sider, tħarħir, pressjoni baxxa, u anafilassi.
English: • Remove the protective paper from the vial adapter.
Maltese: • Neħħi l-karta protettiva mill-adapter tal kunjett.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.