FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity (allergic) reactions are uncommon with Refixia (may affect up to 1 in 100 patients) and may include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġiċi) mhumiex komuni b'Refixia (jistgħu jaffettwaw sa persuna 1 minn kull 100) u jistgħu jinkludu: nefħa, ħruq u tingiż fis-sit tal-injezzjoni, dehxiet ta' bard, fwawar, raxx bil-ħakk, uġigħ ta' ras, urtikarja, pressjoni tad-demm baxxa, letarġija, dardir u rimettar, nuqqas ta' sabar, taħbita mgħaġġla tal-qalb, tagħfis fis-sider u tħarħir.
English: Refixia contains the active substance nonacog beta pegol.
Maltese: Refixia fih is-sustanza attiva nonacog beta pegol.
English: This is a summary of the European public assessment report (EPAR) for Refixia.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Refixia.
English: What are the risks associated with Refixia?
Maltese: X'inhuma r-riskji assoċjati ma' Refixia?
English: Why is Refixia approved?
Maltese: Għaliex ġie approvat Refixia?
English: It can be used in adults and children from 12 years of age.
Maltese: Jista' jintuża fl-adulti u fi tfal ta' aktar minn 12-il sena.
English: In a study involving 74 adults and adolescents aged 13 or above, 29 patients given Refixia as a weekly preventive treatment had around 1 bleeding episode a year, and 15 patients given Refixia for treating bleedings ‘on demand' had around 16 bleeding episodes a year.
Maltese: Fi studju li fih ħadu sehem 74 adult u adolexxenti ta' 13-il sena jew akbar, 29 pazjent li ngħataw Refixia bħala kura preventiva fil-ġimgħa kellhom madwar episodju wieħed ta' fsada fis-sena, u 15-il pazjent li ngħataw Refixia għall-kura ta' fsada ‘fuq talba' kellhom madwar 16-il episodju ta' fsada fissena.
English: Around 86% of bleeding episodes resolved with one injection.
Maltese: Madwar 86% talepisodji ta' fsada kienu solvuti b'injezzjoni waħda.
English: The company that markets Refixia will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Maltese: Il-kumpanija li tqiegħed Refixia fis-suq ser twettaq studju biex jiġu investigati l-effetti potenzjali talakkumulazzjoni ta' PEG fil-choroid plexus tal-moħħ u f'organi oħra.
English: The active substance in Refixia, nonacog beta pegol, works in the body in the same way as human factor IX.
Maltese: Is-sustanza attiva f'Refixia, nonacog beta pegol, taħdem fil-ġisem bl-istess mod bħall-fattur IX uman.
English: However, part of the active substance in Refixia (called PEG) may accumulate in the body, including in a structure in the brain called choroid plexus, following long-term treatment.
Maltese: Madankollu, parti mis-sustanza attiva f'Refixia (imsejħa PEG) tista' takkumula fil-ġisem, inkluż fi struttura fil-moħħ imsejħa choroid plexus, wara kura fit-tul.
English: Studies show that Refixia is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products.
Maltese: L-istudji juru li Refixia huwa effettiv fil-prevenzjoni u fil-kura tal-episodji ta' fsada f'pazjenti blemofilja B u s-sigurtà tiegħu hija komparabbli ma' dik ta' prodotti oħrajn tal-fattur IX.
English: Since this could potentially cause problems especially in children below 12 years of age, Refixia is only approved for use in in adults and children from 12 years of age.
Maltese: Minħabba li potenzjalment dan jista' jikkawża problemi speċjalment fi tfal taħt it-12-il sena, Refixia huwa approvat biss għall-użu fl-adulti u fi tfal ta' aktar minn 12-il sena.
English: Patients had around 1 bleeding episode per year and Refixia was rated excellent or good at treating around 93% of bleeding episodes.
Maltese: Il-pazjenti kellhom madwar episodju wieħed ta' fsada fis-sena u Refixia kien ikkunsidrat bħala eċċellenti jew tajjeb fil-kura ta' madwar 93% tal-episodji ta' fsada.
English: Refixia is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Maltese: Refixia huwa mediċina li tintuża għall-kura u għall-prevenzjoni ta' fsada f'pazjenti bl-emofilja B, disturb tad-demm li jintiret ikkawżat minn nuqqas ta' proteina li tgħaqqad id-demm imsejħa fattur IX.
English: How is Refixia used?
Maltese: Kif jaħdem Refixia?
English: Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Xi pazjenti li jieħdu mediċini tal-fattur IX jistgħu jiżviluppaw inibituri (antikorpi) kontra l-fattur IX, u dan iwassal sabiex il-mediċina tieqaf taħdem u jirriżulta f'telf tal-kontroll tal-fsada.
English: Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Maltese: Pazjenti b'emofilja B għandhom nuqqas ta' fattur IX, proteina meħtieġa għall-koagulazzjoni normali tad-demm, u bħala riżultat jinfasdu faċilment.
English: Refixia must not be used in patients allergic to hamster proteins.
Maltese: Refixia ma għandux jintuża f'pazjenti allerġiċi għall-proteini tal-ħemster.
English: What measures are being taken to ensure the safe and effective use of Refixia?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Refixia?
English: The dose and frequency of treatment depend on whether Refixia is used to treat or prevent bleeding, or to reduce bleeding during surgery, the extent and location of the bleeding, and the patient's bodyweight.
Maltese: Iddoża u l-frekwenza tal-kura jiddependu fuq jekk Refixia jintużax għall-kura jew għall-prevenzjoni ta ᾽ fsada, jew għat-tnaqqis ta' fsada waqt kirurġija, il-firxa u l-post tal-emorraġija, u l-piż tal-ġisem talpazjent.
English: In addition, when bleeding did occur, Refixia was rated excellent or good at treating around 92% of bleeding episodes.
Maltese: Barra minn hekk, meta seħħet il-fsada, il-kura b'Refixia kienet ikklassifikata bħala eċċellenti jew tajba f'madwar 92% tal-episodji ta' fsada. 87% tal-episodji ta' fsada kienu riżolti b'injezzjoni waħda ta' Refixia.
English: Date of first authorisation: 16 March 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Marzu 2016
English: Repeat at intervals of 24 hours until the bleed stops.
Maltese: Irrepeti f'intervalli ta' 24 siegħa sakemm il-fsada tieqaf.
English: A total of 184 infusions of Coagadex were given as a preventative measure.
Maltese: Total ta' 184 infużjoni ta' Coagadex ingħataw bħala miżura preventiva.
English: Virus safety
Maltese: Sigurtà mill-virus
English: 70 kg x 90 IU/dL/{[2 IU/dL]/[IU/kg]} = 3150 IU.
Maltese: IU/dL/{[2 IU/dL]/[IU/kg]} = 3150 IU.
English: 500 IU
Maltese: IU u 500
English: List of adverse reactions (ADRs) in 27 treated subjects MedDRA System Organ Class
Maltese: Lista ta' reazzjonijiet avversi (ADR) f'27 individwu kkurat Sistema tal-Klassifika tal-Organi
English: Paediatric population (less than 12 years of age)
Maltese: Popolazzjoni pedjatrika (inqas minn 12-il sena)
English: Of the 187 bleeding episodes in the efficacy analysis, 155 bleeds (83%) were treated with one infusion, 28 bleeds (15%) with two infusions, 3 bleeds (2%) with three infusions and 1 bleed (0.5%) with four infusions.
Maltese: Mill-187 episodju ta' fsada fl-analiżi tal-effikaċja, 155 episodju ta' fsada (83%) kienu kkurati b'infużjoni waħda, 28 episodju ta' fsada (15%) b'żewġ infużjonijiet, 3 episodji ta' fsada (2%) bi tliet infużjonijiet u episodju 1 ta' fsada (0.5%) b'erba' infużjonijiet.
English: Six children (66.7%) remained free of bleeds during routine prophylaxis.
Maltese: Sitt itfal (66.7%) baqgħu ħielsa minn fsadiet matul il-profilassi ta' rutina.
English: Volume of solvent
Maltese: Volum ta' solvent
English: Transfer Device (Mix2Vial).
Maltese: Tagħmir tat-Trasferiment (Mix2Vial).
English: Sodium hydroxide (for pH adjustment) Disodium phosphate dihydrate Sodium chloride
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Disodium phosphate dihydrate Sodium chloride
English: Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium.
Maltese: Coagadex fih sa 0.4 mmol/mL (9.2 mg/mL) ta' sodium.
English: A total of 537 (mean 59.7 per subject) prophylactic infusions were administered.
Maltese: Ġew mogħtija total ta' 537 (medja ta' 59.7 kull pazjent) infużjoni profilattika.
English: BPL Bioproducts Laboratory GmbH Dornhofstraße, 63263 Neu-Isenburg Germany
Maltese: BPL Bioproducts Laboratory GmbH Dornhofstraße,63263 Neu-Isenburg
English: 1 powder vial
Maltese: 1 kunjett bit-trab
English: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg Germany
Maltese: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg
English: The mean age was 7.3 (range 2.6 to 11.9) years.
Maltese: L-età medja kienet ta' 7.3 (medda minn 2.6 sa 11.9) snin.
English: Allergic type hypersensitivity reactions, including anaphylaxis, are possible.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiku, inkluż anafilassi huma possibbli.
English: 1 Transfer Device (Mix2Vial)
Maltese: 1 Tagħmir ta' Trasferiment (Mix2Vial)
English: The mean (CV%) for area under the curve (AUC 0-144h) was 17.1 (21.0) IU.hr/mL.
Maltese: Il-medja (CV%) għall-erja taħt il-kurva (AUC 0-144h) kienet ta' 17.1 (21.0) IU hr/mL.
English: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Maltese: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, Ir Renju Unit
English: Also contains: Powder vial: citric acid, sodium hydroxide, disodium phosphate dihydrate, sodium chloride, sucrose.
Maltese: Fih ukoll: Powder vial: citric acid, sodium hydroxide, disodium phosphate dihydrate, sodium chloride, sucrose.
English: The mean (CV%) maximum plasma concentration (Cmax) was 0.504 (17.2) IU/mL.
Maltese: Il-medja (CV%) għall-konċentrazzjoni fil-plażma massima (Cmax) kienet 0.504 (17.2) IU/mL.
English: The mean (CV%) half-life of human coagulation factor X was 30.3 (22.8) hr and clearance was 1.35 (21.7) mL/kg/hr.
Maltese: Il-medja (CV%) half-life tal-fattur X tal-koagulazzjoni umana kienet ta' 30.3 (22.8) hr u leliminazzjoni kienet ta' 1.35 (21.7) mL/kg/siegħa.
English: Coagadex contains sodium
Maltese: Coagadex fih is-sodium
English: For the subgroup aged 6-11 years (n=5), the geometric mean IR30min was 1.91 (range 1.6 -2.2) IU/mL per IU/kg and for the youngest subgroup, 0-5 years (n=4) was 1.53range 1.3-1.8) IU/mL per IU/kg.
Maltese: il-medja ġeometrika tal-IR30min kienet ta' 1.91 (medda 1.6-2.2) IU/mL għal kull IU/kg mogħti u għall-iżgħar sottogrupp, 0-5 snin (n=4) kienet ta' 1.53 (medda 1.3-1.8) IU/mL għal kull IU/kg.
English: This medicinal product contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium.
Maltese: Dan il-prodott mediċinali fih sa 0.4 mmol/mL (9.2 mg/mL) ta' sodium.
English: Coagadex was considered to be good (7%) or excellent (91%) in treating 98% of bleeding episodes.
Maltese: Coagadex kien meqjus bħala tajjeb (7%) jew eċċellenti (91%) fil-kura ta' 98% tal-episodji ta' fsada.
English: Human coagulation factor X is largely retained within the vascular compartment: mean apparent volume of distribution (Vss) was 56.3 (24.0) mL/kg.
Maltese: Il-fattur X tal-koagulazzjoni umana huwa prinċipalment miżmum fil-kompartiment vaskulari: medja tal-volum li jidher tad-distribuzzjoni (Vss) kienet ta' 56.3 (24.0) mL/kg.
English: The mean (CV%) for incremental recovery was 2.08 (18.1).
Maltese: Il-medja (CV%) għall-irkupru inkrementali kienet 2.08 (18.1).
English: Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-linked fibrin clot.
Maltese: Thrombin imbagħad jaġixxi fuq fibrinogen solubbli u fattur XIII biex jiġġenera embolu ta' cross-linked fibrin.
English: However, chemical and physical in-use stability has been demonstrated for 1 hour at room temperature (up to 25°C +/-2°C).
Maltese: Madankollu, l-istabbilità kimika u fiżika waqt l-użu ntweriet għal 1 siegħa f'temperatura ambjentali (sa 25°C +/- 2°C).
English: The listed warnings and precautions for adults also apply to children (aged 2 to 11 years) and adolescents (aged 12 to 18 years).
Maltese: It-twissijiet u prekawzjonijiet elenkati għall-adulti japplikaw ukoll għat-tfal (2 sa 11-il sena) u adolexxenti (b'età minn 12 sa 18-il sena).
English: Of the 208 bleeding episodes treated with Coagadex, 187 bleeding episodes in 15 subjects were evaluated for efficacy.
Maltese: Mill-208 episodji ta' fsada kkurati b'Coagadex, 187 episodju ta' fsada fi 15-il pazjent ġew evalwati għall-effikaċja.
English: All were treated with a single infusion of Coagadex; mean and median doses 31.7 IU/kg (range 24.6 to 38.8 IU/kg) and all recorded efficacy ratings were categorized as excellent.
Maltese: Kollha ġew ikkurati b'infużjoni waħda ta' Coagadex; dożi medji u medjani ta' 31.7 IU/kg (medda ta' 24.6 sa 38.8 IU/kg) u l-klassifikazzjoni tal-effikaċja kollha rreġistrati kienu meqjusa bħala eċċellenti.
English: Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL (250 IU) or 5 mL (500 IU) sterilised water for injections.
Maltese: Coagadex fih madwar 100 IU/mL ta' Fattur X tal-koagulazzjoni umana wara r-rikostituzzjoni bi 2.5 mL (250 IU) jew 5 mL (500
English: Each pack contains:
Maltese: Kull pakkett fih:
English: Coagadex contains traces of human proteins other than factor X. Patients should be informed of the early signs of hypersensitivity reactions including angioedema, infusion site inflammation (e.g. burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalised urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar is-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu anġjoedema, infjammazzjoni fis-sit tal-infużjoni (eż. ħruq, tingiż, eritema), tertir ta' bard, sogħla, sturdament, deni, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, uġigħ muskuloskeletali, dardir, ħakk, raxx, nuqqas ta' kwiet fil-ġisem, takikardja, tagħfis tas-sider, tnemnim, rimettar, tħarħir.
English: 500 IU human coagulation factor X, approximately 100 IU/mL
Maltese: IU fattur X tal-koagulazzjoni umana, bejn wieħed u ieħor 100 IU/mL
English: Frequencies have been evaluated according to the following convention: very common (≥1/10 subjects); common (≥1/100 to <1/10).
Maltese: Il-frekwenzi ġew evalwati skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10 individwi), komuni (≥1/100 sa <1/10).
English: Combining IR values for FX:C at the baseline visit (n=16) and the Repeat PK assessment (n=15) gave an overall geometric mean IR of 2.07 IU/dL per IU/kg administered (n=31).
Maltese: Il-kombinament tal-valuri IR għal FX:C fil-viżta tal-linja bażi (n = 16) u l-valutazzjoni tal-PK ripetuta (n = 15) taw medja ġeometrika globali tal-IR ta' 2.07 IU/dL għal kull IU/kg mogħti (n = 31).
English: Pharmacokinetic (PK) parameters were calculated from plasma factor X:C (one-stage clotting assay) activity measurements after subtraction of the pre-dose value.
Maltese: Il-parametri farmakokinetiċi (PK) ġew ikkalkulati mill-kejl tal-attività fil-plażma ta' fattur X:C (assaġġ tat-tagħqid ta' stadju wieħed) wara li tnaqqas il-valur ta' qabel id-doża.
English: Factor X is converted from its inactive form to the active form (factor Xa) by the cleavage of a 52-residue peptide from the heavy chain.
Maltese: Fattur X jiġi kkonvertit mill-forma inattiva tiegħu għall-forma attiva (fattur Xa) mill-qsim ta' peptide bi 52 residwu mill-katina tqila.
English: The measures taken are considered effective for the following viruses: human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus and parvovirus B19.
Maltese: Il-miżuri li jittieħdu huma kkunsidrati li huma effettivi għall-virusijiet li ġejjin: virus tal-immunodefiċjenza umana (HIV), il-virus tal-epatite B, il-virus tal-epatite Ċ, il-virus tal-epatite A, u l-parvovirus B19.
English: A clear or slightly pearl-like solution should be obtained, usually in less than 1 minute (5 minutes maximum).
Maltese: Għandha tinkiseb soluzzjoni ċara jew xi ftit mil-lewn il-perli, normalment f'inqas minn minuta (massimu ta' 5 minuti).
English: There are limited data on the use of Coagadex for long periods of prophylaxis in adults.
Maltese: Hemm data limitata dwar l-użu ta' Coagadex għal perjodi twal ta' profilassi fl-adulti.
English: Detailed information on this medicine is available on the European Medicines Agency web site: 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: Required dose (IU) = body weight (kg) x desired factor X rise (IU/dL) x 0.5
Maltese: Doża meħtieġa (IU) = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur X (IU/dL) x 0.5
English: Coagadex is derived from human plasma and used as a replacement for the naturally existing coagulation factor X in patients with hereditary factor X deficiency.
Maltese: Coagadex hu derivat mill-plażma umana u jintuża bħala sostitut għall-fattur X tal-koagulazzjoni li jeżisti b'mod naturali f'pazjenti b'defiċjenza ereditarja ta' fattur X.
English: The 250 IU and 500 IU presentations should be reconstituted using 2.5 mL and 5 mL water for injections, respectively.
Maltese: IU għandhom jiġu rikostitwiti bl-użu ta' 2.5 mL u 5 mL ilma għall-injezzjonijiet, rispettivament.
English: Example: to raise plasma factor X level from 15 IU/dL to 90 IU/dL in a 70 kg patient, the appropriate dose is:
Maltese: Eżempju: biex iżżid il-livell fil-plażma ta' fattur X minn 15 IU/dL għal 90 IU/dL f'pazjent li jiżen 70 kg, id-doża adattata hi:
English: The median prophylactic dose per infusion per subject was 39.60 IU/kg (mean 38.76 IU/kg), and ranged from 18.0 to 47.3 IU/kg.
Maltese: IU/kg (medja 38.76 IU/kg), fuq medda minn 18.0 sa 47.3
English: 1 vial 250 IU powder 1 vial 2.5 mL water for injections 1 Transfer Device (Mix2Vial)
Maltese: IU ta' trab 1 kunjett ta' 2.5 mL ta' ilma għall-injezzjonijiet 1 tagħmir ta' Trasferiment (Mix2Vial)
English: Step 6: Immediately invert the vial of solution, which will be drawn into the syringe.
Maltese: Pass 6: Immedjatament aqleb il-kunjett bis-soluzzjoni, li se jinġibed għal ġos-siringa.
English: Coagadex should not be used as an antidote to the effects of direct oral anti-coagulants (DOACs) in patients who do not have factor X deficiency.
Maltese: Coagadex m'għandux jintuża bħala antidotu għall-effetti ta' antikoagulanti orali diretti (direct oral anti-coagulants, DOACs) f'pazjenti li ma jkollhomx defiċjenza tal-fattur X.
English: There are no data available on routine prophylaxis in paediatric patients aged >12 to <18 years.
Maltese: M'hemm l-ebda data disponibbli dwar il-profilassi ta' rutina f'pazjenti pedjatriċi ta' età >12-il sena u <18-il sena.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Maltese: Il-miżuri meħudin huma meqjusa effettivi għal virusijiet enveloppati bħal HIV, HBV u HCV, u għall virusijiet mhux enveloppati HAV u parvovirus B19.
English: 1 solvent vial of 5 mL water for injections
Maltese: 1 kunjett tas-solvent ta' 5 mL ilma għall-injezzjonijiet
English: Pharmacokinetic studies have not been performed in children under the age of 12 years.
Maltese: Ma sarux studji farmakokinetiċi fi tfal taħt l-età ta' 12-il sena.
English: Three children (33.3%), one in the 0-5 years age group and two in the 6-11 years age group had a total of 10 bleeds due to epistaxes, trauma or menorrhagia.
Maltese: Tlett itfal (33.3%), wieħed fil-grupp ta' età bejn 0-5 snin u tnejn fil-grupp ta' età ta' 6-11
English: Hypersensitivity reactions, allergic reactions, and anaphylaxis have not been reported in Coagadex clinical trials.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, reazzjonijiet allerġiċi, u anafilassi ma ġewx irrappurtati fi provi kliniċi b'Coagadex.
English: Frequencies of uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Maltese: Il-frekwenzi ta' mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000) jew rari ħafna (<1/10,000) ma tistax tittieħed stima mid-data disponibbli.
English: Eight subjects had severe FX deficiency, the other had moderate deficiency.
Maltese: Tmien pazjenti kellhom insuffiċjenza severa ta' FX, l-ieħor kellu insuffiċjenza moderata.
English: Bio Products Laboratory Ltd Teл.
Maltese: Bio Products Laboratory Ltd Tlf: +44
English: 1 solvent vial of 2.5 mL water for injections
Maltese: 1 kunjett tas-solvent b'2.5 mL ilma għall-injezzjonijiet.
English: Prophylaxis of Bleeding Episodes
Maltese: Profilassi ta' Episodju ta' Fsada
English: Similarly, combining t½ values at the Baseline Visit and the Repeat PK assessment gave an overall geometric mean t½ of 29.36 hours.
Maltese: Bl-istess mod, il-kombinament tal-valuri t½ fil-Viżta tal-Linja Bażi u l-valutazzjoni tal-PK ripetuta taw medja ġeometrika globali ta' t½ ta' 29.36 siegħa.
English: Pregnancy
Maltese: Preżentazzjonijiet
English: The factor X in Coagadex is extracted from human plasma (the liquid part of blood).
Maltese: Il-fattur X f'Coagadex huwa estratt mill-plażma umana (il-parti likwida tad-demm).
English: Patients may vary in their pharmacokinetic (e.g. half-life, in vivo recovery) and clinical responses to Coagadex.
Maltese: Il-pazjenti jistgħu jvarjaw fir-risponsi farmakokinetiċi tagħhom (eż. half-life, in vivo irkuprar) u kliniċi għal Coagadex.
English: For minor surgery, a median of 2.5 infusions (range 1 to 4 infusions) and a median cumulative dose of 89 IU/kg (range 51 to 127 IU/kg) were used to maintain haemostasis.
Maltese: Għal kirurġija minuri, medja ta' 2.5 infużjonijiet (medda ta' 1 sa 4 infużjonijiet) u doża kumulattiva medja ta' 89 IU/kg (medda ta' 51 sa
English: Not more than 60 IU/kg daily should be administered in any age group.
Maltese: IU/kg kuljum fi kwalunkwe grupp ta' età.
English: Median and mean doses per infusion in the four children less than 6 years of age were both 40.1 IU/kg (95% CI 30.70, 49.57) and in the five children 6 to 11 years of age inclusive, median dose was 39.6 IU/kg and mean dose was 37.7 IU/kg (95% CI: 23.42, 51.91).
Maltese: IU/kg u doża medja ta' 37.7 IU/kg (95% CI: 23.42, 51.91).
English: Perioperative Management (Adults and adolescents aged at least 12 years of age) Pre-surgery: calculate dose of Coagadex to raise plasma factor X levels to 70-90 IU/dL.
Maltese: Immaniġġjar Perioperattiv (Adulti u adolexxenti li għandhom tal-anqas 12-il sena) Qabel l-operazzjoni: ikkalkula d-doża ta' Coagadex biex iżżid il-livelli fil-plażma ta' fattur X għal 70-90
English: - Solvent: water for injections.
Maltese: - Solvent: ilma għall-injezzjonijiet.
English: Factor Xa associates with factor Va on a phospholipid surface to form the prothrombinase complex, which activates prothrombin to thrombin in the presence of calcium ions.
Maltese: Fattur Xa jassoċja ma' fattur Va fuq wiċċ fosfolipidu biex jifforma l-kumpless prothrombinase, li jattiva prothrombin għal thrombin fil-preżenza ta' joni tal-kalċju.
English: In a multicentre, open-label, non-randomised clinical trial to evaluate the pharmacokinetics, safety and efficacy of Coagadex, 16 subjects (aged 12 years and above) with moderate to severe hereditary factor X deficiency (FX:C < 5 IU/dL) received a dose of 25 IU/kg Coagadex to treat spontaneous, traumatic and menorrhagic bleeding episodes.
Maltese: Fi prova klinika b'ħafna ċentri, open-label, mhux randomizzata sabiex tevalwa l-farmakokinetika, is-sigurtà u l-effikaċja ta' Coagadex, 16-il individwu (età minn 12-il sena 'l fuq) b'defiċjenza ereditarja tal-fattur X minn moderata għal severa (FX:C <5