FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety was demonstrated in 3-week-old and adult chickens treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.
Maltese: Is-sigurtà ġiet demostrata f`tiġieġ ta` 3 ġimġħat u tiġieġ adulti ddużati b`doża sa 5 darbiet aktar middik rakkomandata għall-perjod ta` trattament 3 darbiet dak rakkomandat.
English: Target tissues Other provisions
Maltese: TWISSIJIET SPEĊJALI
English: Fluralaner degrades in aquatic sediment under anaerobic conditions while it has been shown to be very persistent under aerobic conditions.
Maltese: Fluralaner ġie muri li jippersisti ħafna fil-ħamrija kemm taħt kundizzjonijiet anerobiċi kif ukoll erobiċi.
English: Exzolt 10 mg/ml solution for use in drinking water for chickens fluralaner
Maltese: Exzolt 10 mg/ml soluzzjoni għall-użu fl-ilma tax-xorb għat-tiġieġ fluralaner
English: Treatment of poultry red mite (Dermanyssus gallinae) infestation in pullets, breeders and layer hens.
Maltese: Trattament għall-infestazzjoni tal-mite aħmar tat-tiġieġ (Dermanyssus gallinae) f`għawietaq, tattgħammir u tiġieġ tal-bajd.
English: Muscle Skin and fat in natural proportions Liver
Maltese: Muskolu Ġilda u xaħam fi proporzj onijiet naturali Fwied Kliewi Bajd
English: No significant metabolites are observed in chickens, and fluralaner is mainly eliminated via the hepatic route.
Maltese: L-ebda metaboliti sinifikanti mhuma osservati fit-tiġieġ, u fluralaner huwa prinċipalment eliminat mill-fwied.
English: No adverse reactions were observed following the treatment of 3-week old and adult chickens dosed with up to 5 times the recommended dose for 3 times the recommended duration of treatment.
Maltese: L-ebda effetti mhux mixtieqa ma ġew osservati wara trattament ta` tiġieġ ta` 3 ġimġħat u tiġieġ adulti ddużati b`doża sa 5 darbiet aktar minn dik rakkomandata għall-perjod ta` trattament 3 darbiet dak rakkomandat.
English: Chickens (pullets, breeders and layer hens).
Maltese: Tiġieġ (għawietaq, tat-tgħammir u tiġieġ tal-bajd).
English: Kidney Eggs
Maltese: U L-UŻU
English: Scale
Maltese: Skala
English: Adolescents <18 years) PTP
Maltese: Adolexxenti <18-il sena) PTP
English: The specific activity of NovoEight is approximately 8,300 IU/mg protein.
Maltese: L-attività speċifika ta' NovoEight hija madwar 8,300 IU/mg ta' proteina.
English: Solvent for NovoEight Sodium chloride 9 mg/ml
Maltese: Sodium chloride 9 mg/ml
English: NovoEight contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa.
Maltese: Kull kunjett ta' NovoEight b'mod nominali fih 250, 500, 1000, 1500, 2000 jew 3000 IU turoctocog alfa.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata taħt hija skont il-klassifikazzjoni tas-sistemi u tal-organi MedDRA (SOC - system organ classification u Preferred Term Level).
English: The solvent is a sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Is-solvent huwa soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: NovoEight contains sodium
Maltese: NovoEight fih sodium
English: Date of first authorisation: 13 November 2013 Date of latest renewal: 30 July 2018
Maltese: Data tal-aħħar tiġdid: 30 Lulju 2018
English: Of the 3,293 reported bleeds observed in 298 of the patients, 2,902 (88.1%) of the bleeds were resolved with 1-2 infusions of NovoEight.
Maltese: Mit-3,293 fsada rrappurtata, osservati f'298 tal-pazjenti, 2,902 (88.1%) mit-total ta' fsada twaqfu b'1-2 infużjonijiet ta' NovoEight.
English: Surgery There is limited experience of surgery in paediatric patients.
Maltese: Anzjani Hemm esperjanza limitata f'kirurġija ta' pazjenti pedjatriċi.
English: Turoctocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 1,445 amino acids with an approximate molecular mass of 166 kDA.
Maltese: Turoctocog alfa (fattur VIII tal-koagulazzjoni tal-bniedem (rDNA)) huwa proteina ppurifikata li għandu 1,445 aċidu amminiku b'massa molekulari ta' madwar 166 kDA.
English: Store in refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Table 3 Consumption of NovoEight and haemostatic success rates in previously untreated patients (PUP) and previously treated patients (PTP)
Maltese: Tabella 3 Konsum ta' NovoEight u rati emostatiċi ta' suċċess f'pazjenti mhux ikkurati preċedentement (PUP- previously untreated patients ) u f'pazjenti kkurati preċedentement (PTP
English: Some variation was observed in the pharmacokinetic parameters of NovoEight between paediatric and adult patients.
Maltese: Kienet osservata xi varjazzjoni fil-parametri farmakokinetiċi ta' NovoEight bejn pazjenti pedjatriċi u adulti.
English: Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid Solvent: Sodium chloride, water for injections
Maltese: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid
English: Obese class II/III N=7
Maltese: Obeżità klassi II/III
English: AUC ((IU*h)/dl) 1510 (360) 1920 (610) CL (ml/h/kg) t½ (h)
Maltese: AUC ((IU*siegħa)/dl) 992 (411) CL (ml/siegħa/kg) t½ (sigħat)
English: Normal weight N=7
Maltese: Piż normali N=7
English: AUC ((IU*h)/dl)
Maltese: AUC (IU*siegħa)/dl)
English: 188 out of 238 previously treated patients continued into the safety extension trial.
Maltese: 188 minn 238 pazjent ikkurati preċedentement komplew fil-prova ta' estensjoni ta' sigurtà.
English: Frequency of doses (hours)/Duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat)/Tul ta' żmien tat-terapija (jiem)
English: Abbreviations: AUC = area under the factor VIII activity time profile; CL = clearance; t1/2 = terminal half-life; Vss = volume of distribution at steady-state; Cmax = maximum factor VIII activity.
Maltese: AUC = erja taħt il-profil tal-attività tal-fattur VIII mal-ħin; CL = tneħħija; t1/2 = half-life terminali;
English: <6 years) PUP
Maltese: Tfal żgħar <6 snin) PUP
English: The injection is given every 2 to 3 days.
Maltese: Linjezzjoni tingħata kull 2 sa 3 ijiem.
English: CL (ml/h/kg) t½ (h)
Maltese: CL (ml/siegħa/kg) t½ (sigħat)
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
Maltese: Il-frekwenzi ġew stmati 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: AUC ((IU*h)/dl) 1860 (700) 2730 (860)
Maltese: AUC ((IU*siegħa)/dl) 1,223 (436)
English: Incremental recovery (IU/dl)/(IU/kg)
Maltese: Irkupru inkrementali (IU/dl)/(IU/kg)
English: NovoEight 250 IU
Maltese: NovoEight 250
English: Calcium chloride dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Calcium chloride dihydrate Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: The recommended infusion rate for NovoEight is 1-2 ml/min.
Maltese: Ir-rata ta' infużjoni rrakkomanadata għal NovoEight hija 1-2 ml/min.
English: EXP
Maltese: PTP
English: High risk genetic mutations were identified in 92.3% of the overall and 93.8% of the high titre confirmed inhibitors.
Maltese: Ġew identifikati mutazzjonijiet ġenetiċi ta' riskju għoli f'92.3% tat-total u f'93.8% ta' dawk li kellhom inibituri kkonfemati b'titru għoli.
English: The tyrosine sulphation site present at Tyr1680 (native full length), which is important for the binding to von Willebrand factor, has been found to be fully sulphated in the turoctocog alfa molecule.
Maltese: Is-sit ta' sulfazzjoni ta' tyrosine preżenti fil-punt Tyr1680 (tul sħiħ nattiv), li huwa importanti għall-irbit mal-fattur von Willebrand, instab li huwa kompletament sulfatat fil-molekula turoctocog alfa.
English: 9 months at room temperature (≤30°C)
Maltese: 9 xhur f'temperatura tal-kamra (≤ 30°C)
English: The maximum exposure (Cmax) and the total exposure (AUC) increase with increasing BMI indicating that dose adjustments may be required for underweight (BMI <18.5 kg/m2) and obese patients (BMI ≥30 kg/m2), see section 4.2.
Maltese: L-espożizzjoni massima (Cmax) u lespożizzjoni totali (AUC) jiżdiedu meta jiżdied il-BMI li turi li jista' jkun hemm bżonn ta' aġġustamenti fiddoża għal pazjenti neqsin mill-piż (BMI <18.5 kg/m2) u obeżi (BMI ≥30 kg/m2), ara sezzjoni 4.2.
English: FVIII level required (%) (IU/dl)
Maltese: Livell meħtieġ ta' FVIII (%) (IU/dl)
English: 0 − <6 years 6 − <12 years ≥12 years n=14
Maltese: 0 − <6 snin 6 − <12-il sena
English: • 24 hours stored at 2°C - 8°C
Maltese: • 24 siegħa meta nħażen f'temperatura ta' 2°C - 8°C
English: Flushing, Thrombophlebitis superficial
Maltese: tromboflebite superfiċjali
English: Three of these trials were performed in previously treated patients and the fourth in previously untreated patients.
Maltese: previously treated patients)
English: BW: Body weight, SD: Standard deviation a Success is defined as either 'Excellent' or 'Good'.
Maltese: BW: Piż tal-ġisem (BW -body weight), SD: Devjazzjoni standard (SD - Standard deviation) a Is-suċċess ġie ddefinit jew bħala 'Eċċellenti' jew 'Tajjeb'.
English: The trials included 298 exposed patients; 175 adolescents or adult patients without inhibitors from the age of 12 years (≥150 exposure days), 63 previously treated paediatric patients without inhibitors below 12 years of age (≥50 exposure days) and 60 previously untreated patients below 6 years of age.
Maltese: Il-provi kienu jinkludu 298 pazjent espost; 175 adolexxent jew pazjent adult mill-età ta' 12-il sena mingħajr inibituri (≥150 jum ta' esponiment), 63 pazjent pedjatriku kkurati preċedentement taħt l-età ta' 12-il sena mingħajr inibituri (≥50 jum ta' esponiment) u 60 pazjent taħt l-età ta' 6 snin li ma kinux ikkurati preċedentement.
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dl) x 0.5 (IU/kg per IU/dl).
Maltese: Unitajiet meħtieġa = il-piż tal-ġisem (kg) x kemm hu meħtieġ jogħla l-fattur VIII (%) (IU/dl) x 0.5
English: Table 2 Frequency of adverse drug reactions in clinical trials
Maltese: Tabella 2 Frekwenza tar-reazzjonijiet avversi għall-mediċina fi provi kliniċi Klassi tas-Sistemi u tal
English: Sinus tachycardia, acute myocardial infarction
Maltese: Takikardija tas-sinus, infart mijokardijaku akut
English: Musculoskeletal stiffness, arthropathy, pain in extremity, musculoskeletal pain
Maltese: Ebusija muskoluskeletrika, artropatija, uġigħ fl-idejn u fis-saqajn, uġigħ muskoluskelettriku
English: Mean residence time (h)
Maltese: residenza (sigħat)
English: NovoEight 1500 IU
Maltese: NovoEight 1500
English: Mean residence time (h) a BMI groups: Underweight: BMI <18.5 kg/m2, Normal weight: BMI 18.5-24.9 kg/m2, Overweight: BMI 25-29.9 kg/m2, Obese class I: BMI 30-34.9 kg/m2, Obese class II/III: BMI ≥35 kg/m2.
Maltese: 9 kg/m2, Obeżità klassi I: BMI 30-34.9 kg/m2, Obeżità klassi II/III:
English: For storage at room temperature (≤30°C) or up to 40°C and storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-ħażna f'temperatura tal-kamra (≤30°C) jew sa 40°C u kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: - The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)).
Maltese: − Is-sustanza attiva hi turoctocog alfa (fattur VIII tal-koagulazzjoni tal-bniedem (rDNA)).
English: In clinical trials involving 63 previously treated paediatric patients between 0 and 12 years of age and 24 adolescents between 12 and 18 years of age with severe haemophilia A no difference in the safety profile of NovoEight was observed between paediatric patients and adults.
Maltese: F'provi kliniċi li kienu jinvolvu 63 pazjent pedjatriku kkurat preċedentement bejn l-etajiet ta' 0 u 12-il sena u 24 adolexxent bejn l-etajiet ta' 12 u 18-il sena b'emofilja A qawwija, ma kienet osservata l-ebda differenza fil-profil ta' sigutrtà ta' NovoEight bejn pazjenti pedjatriċi u adulti.
English: After reconstitution with the supplied solvent (sodium chloride 9 mg/ml (0.9%) solution for injection), the prepared solution for injection contains 62.5, 125, 250, 375, 500 or 750 IU turoctocog alfa per ml, respectively, (based on the strength of turoctocog alfa, i.e. 250, 500, 1000, 1500, 2000 or 3000 IU).
Maltese: Wara r-rikostituzzjoni bis-solvent fornut (soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride) issoluzzjoni għall-injezzjoni ppreparata jkun fiha 62.5, 125, 250, 375, 500 jew 750
English: A total of 30 surgeries were performed in 25 patients of which 26 were major surgeries and 4 were minor.
Maltese: Saru total ta' 30 operazzjoni fuq 25 pazjent li minnhom 26 kienu operazzjonijiet serji u 4 kienu żgħar.
English: In the trial with previously untreated patients, between 0 and 6 years of age, a total of 46 adverse reactions were reported in 33 of 60 patients exposed to NovoEight.
Maltese: Fil-prova f'pazjenti li ma kinux ikkurati preċedentement, bejn l-etajiet ta' 0 u 6 snin, ġew irrapportati total ta' 46 reazzjoni avversa f'33 minn 60 pazjent esposti għal NovoEight.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Maltese: Ma ġew irrappurtati l-ebda interazzjonijiet bejn prodotti ta' fatturi VIII (rDNA) tal-koagulazzjoni talbniedem ma' prodotti mediċinali oħra.
English: Overweight N=8
Maltese: Piż żejjed N=8
English: This is equivalent to 1.5% of the recommended maximum dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.5% tal-ammont massimu rrakkomandat ta' sodium li jista' jittieħed mid-dieta għal adult.
English: L-histidine
Maltese: L-histidine Sucrose
English: NovoEight 500 IU
Maltese: NovoEight 500
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji,toraċiċi u medjastinali
English: Uncommonb
Maltese: Tbenġil
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, fattur VIII tal-koagulazzjoni tad-demm, Kodiċi ATC:
English: Inject slowly over 2 to 5 minutes.
Maltese: • Injetta bil-mod fuq perjodu ta' 2 sa 5 minuti.
English: During all clinical studies with NovoEight in previously treated patients, a total of 35 adverse reactions were reported in 23 of 242 patients exposed to NovoEight.
Maltese: Waqt l-istudji kliniċi kollha b'NovoEight f'pazjenti kkurati preċedentement, total ta' 35 reazzjoni avversa kienu rrappurtati f'23 mill-242 pazjent esposti għal NovoEight.
English: - The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine,
Maltese: − Is-sustanzi l-oħra huma L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide u hydrochloric acid.
English: Excipient with known effect The medicinal product contains 30.5 mg sodium per reconstituted vial.
Maltese: Eċċipjenti b'effett magħruf Il-prodott mediċinali fih 30.5 mg sodium f'kull kunjett rikostitwit.
English: Spike (under protective paper)
Maltese: Ponta (taħt il-karta protettiva)
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Thrombin imbagħad jibdel fibrinogen f'fibrin u jista' jiġi ffurmat tagħqid tad-demm.
English: NovoEight 2000 IU
Maltese: NovoEight 2000
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali ara sezzjoni 6.3.
English: Cardiovascular event
Maltese: Avveniment kardjovaskulari
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Maltese: IgG immirati kontra l-attività favur il-koagulazzjoni tal-fattur VIII, li huma kkwantifikati f'Unitajiet Bethesda (BUBethesda Units) f'kull ml ta' plażma bl-użu tal-assaġġ modifikat.
English: Overweight N=9
Maltese: Piż żejjed N=9
English: SN: NN:
Maltese: SN:
English: Plastic cap
Maltese: Għatu tal-plastik
English: 3 months at above room temperature (30°C up to 40°C).
Maltese: 3 xhur f'temperatura aktar 'il fuq minn dik ta' kamra (30°C sa 40°C).
English: Rash, lichenoid keratosis, skin burning sensation
Maltese: Raxx, raxx eritematożu, keratożi liċenojde, sensazzjoni ta' ħruq fil-ġilda
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: Reazzjonijiet ta' sensittività eċċessiva jew allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit talinfużjoni, tkexkix ta' bard, fwawar, urtikarja mifruxa, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, nawsja, nuqqas ta' kwiet, takikardija, tagħfis fis-sider, tingiż, rimettar, tħarħir) ġew osservati b'mod rari u jistgħu f'xi każijiet jiżviluppaw f'anafilassi qawwija (inkuż xokk).
English: NovoEight contains turoctocog alfa, a human coagulation factor VIII (rDNA), with a truncated Bdomain.
Maltese: NovoEight fih turoctocog alfa, fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), b'dominju B mqassar.
English: This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
Maltese: Din il-mediċina fiha 30.5 mg sodium (komponent prinċipali tal-melħ tat-tisjir/ta' fuq il-mejda) f'kull kunjett rikostitwit.
English: Mean (SD) Min ; Max Success ratea
Maltese: (IU/kg BW) Medja (SD) Min ; Max
English: NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII.
Maltese: NovoEight fih is-sustanza attiva turoctocog alfa, fattur VIII tal-koagulazzjoni tal-bniedem.
English: The medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Il-prodott mediċinali fih 30.5 mg sodium għal kull kunjett rikostitwit, ekwivalenti għal 1.5% tal-ammont massimu rrakkomandat mill-WHO ta' 2 g sodium li jista' jittieħed kuljum minn adult.
English: Check the expiry date.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: • Periodic Safety Update Reports (PSUR)
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà (PSUR)
English: Novo Nordisk A/S Novo Allé
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Novo Nordisk A/S
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Maltese: B'mod partikolari f'każ ta' interventi kirurġiċi maġġuri, monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz tal-analiżi tal-koagulazzjoni (attività tal-fattur VIII fil-plażma) hija indispensabbli.
English: In a single dose pharmacokinetic study in adult patients the maximum exposure (Cmax) and the total exposure (AUC) increased with increasing body mass index (BMI) indicating that dose adjustments may be required.
Maltese: F'studju farmakokinetiku b'doża waħda f'pazjenti adulti l-espożizzjoni massima (Cmax) u lespożizzjoni totali (AUC) żdiedu meta żdiedet l-indiċi tal-massa tal-ġisem (BMI) li turi li jista' jkun hemm bżonn ta' aġġustamenti fid-doża.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Maltese: Ta' min jinnota li r-rata annwalizzata ta' fsada (ABR, annualised bleeding rate) mhijiex kumparabbli bejn konċentrati ta' fatturi differenti u bejn studji kliniċi differenti.
English: Table 1 Guide for dosing in bleeding episodes and surgery
Maltese: Tabella 1 Gwida għad-dożaġġ f'episodji ta' fsada u kirurġija
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl)
Maltese: Irrepeti l-infużjoni kull 8-24 siegħa sakemm ikun hemm fejqan xieraq talferita, imbagħad terapija għal millinqas 7 ijiem oħra biex l-attività talfattur VIII tinżamm minn 30% sa 60% (IU/dl)
English: Turoctocog alfa is a B-domain truncated recombinant human coagulation factor VIII (B-domain consists of 21 amino acids of the wild type B-domain) without any other modifications in the amino acid sequence.
Maltese: Turoctocog alfa huwa fattur VIII tal-koagulazzjoni tal-bniedem rikombinat bid-dominju B mqassar (iddominju B jikkonsisti f'21 aċidu amminiku tad-dominju B li jinstab fin-natura) mingħajr l-ebda tibdil ieħor fis-sekwenza tal-aċidi amminiċi.
English: Pyrexia, catheter site erythema
Maltese: Reazzjonijiet fis-sit talinjezzjonic
English: Fatigue, feeling hot, oedema peripheral, pyrexia
Maltese: Għeja, tħoss is-sħana, edima periferali, deni
English: NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Maltese: NovoEight 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett ta' trab fih nominalment 3000 IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa.
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Maltese: Kura u profilassi għall-fsada f'pazjenti b'emofilja A (defiċjenza konġenitali tal-fattur VIII).
English: NovoEight 1000 IU
Maltese: NovoEight 1000
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Maltese: Għal tfal li ma ġewx ikkurati preċedentement b'mediċini ta' Fattur VIII, il-formazzjoni ta' antikorpi inibitorji tista' tkun komuni ħafna (aktar minn pazjent 1 minn kull 10); madankollu, pazjenti li rċevew kura preċedentement b'Fattur VIII (aktar minn 150 ġurnata ta' kura) ir-riskju mhuwiex komuni (anqas minn pazjent 1 minn kull 100).
English: • stiffness of muscles
Maltese: • ebusija tal-muskoli
English: Of the 35 adverse reactions, 2 were reported in 1 out of 31 patients below 6 years of age, none in patients from 6 to ≤12 years of age, 1 event in 1 out of 24 patients (12 to <18 years of age) and 32 were reported in 21 out of 155 adults (≥18 years).
Maltese: Mill-35 reazzjoni avversa, 2 kienu rrappurtati f'1 mill-31 pazjent taħt l-età ta' 6 snin, l-ebda waħda f'pazjenti mill-età ta' 6 sa ≤12 -il sena, avveniment 1 f'1 mill-24 pazjent (12 sa <18-il sena) u 32 kienu rrappurtati f'21 minn 155 adult (≥18-il sena).
English: Hypertension, lymphoedema, hyperaemia
Maltese: Pressjoni għolja, limfedima, iperimja
English: Other medicines and NovoEight
Maltese: Mediċni oħra u NovoEight
English: Underweight N=5
Maltese: N=5
English: Older children
Maltese: Adulti
English: Thread
Maltese: Rimettar
English: Prevention of bleeding
Maltese: Għatu protettiv