FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, the solution has a pH of 6.7 to 7.3.
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni jkollha pH ta' 6.7 sa 7.3.
English: The safety, efficacy, and pharmacokinetics of ADYNOVI were evaluated in a pivotal multicenter, open-label, prospective clinical trial that compared the efficacy of a twice weekly prophylactic treatment regimen to on-demand treatment and determined haemostatic efficacy in the treatment of bleeding episodes.
Maltese: Is-sigurtà, l-effikaċja, u l-farmakokinetika ta' ADYNOVI ġew evalwati fi prova klinika multiċentrika, open-label u prospettiva li qabblet l-effikaċja ta' kors ta' kura profilattika darbtejn fil-ġimgħa ma' kura skont il-bżonn (on demand treatment) u ddeterminat l-effikaċja emostatika fil-kura ta' episodji ta' fsada.
English: Allow the vials of powder and solvent to reach room temperature (between 15 °C and 25 °C) before use.
Maltese: Ħalli l-kunjetti tat-trab u s-solvent jilħqu t-temperatura ambjentali (bejn 15°C u 25°C) qabel lużu.
English: The median overall ABR was 2.0 (IQR: 3.9) for the 65 subjects in the per-protocol population and the median ABRs for spontaneous and joint bleeding episodes were both 0 (IQR: 1.9).
Maltese: L-ABR globali medjana kienet 2.0 (IQR: 3.9) għall-65 individwu fil-popolazzjoni skont il-protokoll u l-ABRs medjani għal episodji ta' fsada spontanja u dik fil-ġogi kienu t-tnejn 0 (IQR: 1.9).
English: The specific activity of ADYNOVI is approximately 4000-6500 IU/mg protein.
Maltese: L-attività speċifika ta' ADYNOVI hija madwar 4000-6500
English: These measures will help protect the environment.
Maltese: IU /mg ta' proteina.
English: A total of 21 major surgical procedures and 5 additional minor surgeries were performed and assessed in 21 unique subjects in the surgery study.
Maltese: Fl-istudju tal-kirurġija twettqu total ta' 21 proċedura kirurġika maġġuri u 5 kirurġiji minuri addizzjonali u ġew ivvalutati f'21 individwu uniku.
English: The mean dose (SD) was 54.3 (6.3) IU/kg and the median frequency of infusions per week was 1.87.
Maltese: Id-doża medja (SD) kienet 54.3 (6.3) IU/kg u l-frekwenza medjana ta' infużjonijiet fil-ġimgħa kienet 1.87.
English: Overall, 95.9% of bleeding episodes were controlled with 1 to 2 infusions and 85.5% were controlled with only 1 infusion.
Maltese: B'mod ġenerali, 95.9% tal-episodji ta' fsada kienu kkontrollati b'infużjoni 1 sa 2 u 85.
English: ADYNOVI contains sodium
Maltese: ADYNOVI fih is-sodium
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30 °C.
Maltese: L-istabbilità kimika u fiżika waqt l-użu ntweriet għal 3 sigħat f'temperatura ta' mhux aktar minn 30°C.
English: Rurioctocog alfa pegol (pegylated recombinant human coagulation factor VIII)
Maltese: Rurioctocog alfa pegol (fattur VIII pegilat tal-koagulazzjoni tal-bniedem rikombinanti)
English: An increase in AUC and a decrease in clearance as compared to the parent molecule, octocog alfa, were also observed.
Maltese: Ġew osservati wkoll żieda fl-AUC u tnaqqis fl-eliminazzjoni meta mqabbla mal-molekula oriġinali, octocog alfa.
English: Paediatric population < 12 years of age
Maltese: Popolazzjoni pedjatrika < 12-il sena
English: The median number of exposure days to ADYNOVI per subject was 103.5 (min-max: 1-278).
Maltese: In-numru medjan ta' jiem ta' esponiment għal ADYNOVI għal kull pazjent kien 103.5 (minimumassimu: 1-278).
English: A higher dose may be required in children less than 12 years of age, see section 4.2.
Maltese: Tista' tkun tkun meħtieġa doża ogħla fi tfal ta' inqas minn 12-il sena, ara sezzjoni 4.2.
English: - ADYNOVI with BAXJECT II Hi-Flow device: Each pack contains a powder vial, a solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Maltese: - ADYNOVI b'apparat BAXJECT II HI-FLOW: Kull pakkett fih kunjett tat-trab, kunjett tassolvent u apparat għar-rikostituzzjoni (BAXJECT II HI-FLOW).
English: • Administer as soon as possible, but no later than 3 hours after reconstitution.
Maltese: • Agħtiha malajr kemm jista' jkun iżda mhux aktar tard minn 3 sigħat wara r-rikostituzzjoni.
English: The clearance value of 12.18 ml/(kg·h) for subject 122001 in age group 12 to < 18 years was not included in the analysis of clearance.
Maltese: Il-valur tat-tneħħija ta' 12.18 mL/(kg·h) għal individwu 122001 fil-grupp ta' età ta' 12 sa < 18il sena ma kienx inkluż fl-analiżi tat-tneħħija.
English: Store refrigerated (2°to 8 °C).
Maltese: Aħżen fi friġġ (2C - 8°C).
English: Population PK with sparse sampling b
Maltese: Popolazzjoni PK b'kampjunar skars b
English: Every 24 hours at least 1 day, until healing is achieved.
Maltese: Kull 24 siegħa mill-inqas ġurnata, sakemm ikun hemm fejqan.
English: The median total dose for major surgeries was 553 IU/kg (range: 248-1394 IU/kg) and the median total dose of minor surgeries was 106 IU/kg (range: 76132 IU/kg).
Maltese: IU/kg) u d-doża totali medjana għal kirurġiji minuri kienet 106 IU/kg (medda: 76-132 IU/kg).
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi, Fattur VIII ta' koagulazzjoni tad-demm, Kodiċi ATC:
English: Usually, the replacement therapy with ADYNOVI is a life-long treatment.
Maltese: Ġeneralment it-terapija ta' sostituzzjoni b'ADYNOVI hija trattament għal tul ħajtek.
English: Forty out of 101 subjects (40%) experienced no bleeding episodes, 58 out of 101 subjects (57%) experienced no joint bleeding episodes, and 58 out of 101 subjects (57%) experienced no spontaneous bleeding episodes in the prophylaxis arm. All subjects in the on-demand arm experienced a bleeding episode, including a joint or spontaneous bleeding episode.
Maltese: Erbgħin minn 101 individwu (40%) ma esperjenzaw l-ebda episodju ta' fsada, 58 minn 101 individwu (57%) ma esperjenzaw l-ebda episodju ta' fsada fil-ġogi, u 58 minn 101 individwu (57%) ma esperjenzaw l-ebda episodju ta' fsada spontanja fil-fergħa ta' profilassi.
English: Abbreviations: Cmax: maximum observed activity; AUC: area under the curve; MRT: mean residence time; CL: clearance; Vss: body weight adjusted volume of distribution at steady-state,
Maltese: Cmass: attività massima osservata; AUC: l-erja taħt il-kurva;
English: The pharmacokinetics (PK) of ADYNOVI were evaluated in a crossover study with octocog alfa in 26 subjects (18 adults and 8 adolescents) and in 22 subjects (16 adults and 6 adolescents) after 6 months of treatment with ADYNOVI.
Maltese: Il-farmakokinetika (PK) ta' ADYNOVI ġiet evalwata fi studju inkroċjat (crossover study) b'octocog alfa f'26 individwu (18-il adult u 8 adolexxenti) u fi 22 individwu (16-il adult u 6 adolexxenti) wara 6 xhur ta' kura b' ADYNOVI. L-attività tal-fattur VIII fil-plażma tkejlet mill-assaġġ ta' koagulazzjoni ta' stadju wieħed u l-assaġġ kromoġeniku.
English: Adjustments of doses and administration intervals may be considered based on achieved FVIII levels and individual bleeding tendency (see section 5.2).
Maltese: Aġġustamenti tad-dożi u intervalli tal-għoti jistgħu jiġu aġġustati abbażi livelli miksuba ta' FVIII u t-tendenza individwali ta' fsada (ara sezzjoni 5.2).
English: Marketing Authorisation Holder Baxalta Innovations GmbH Industriestrasse 67
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Baxalta Innovations GmbH Industriestrasse 67
English: Terminal half--life [h] MRT [h] CL [mL/(kg·h)]
Maltese: [h] MRT [h] CL [mL/(kg·h)] Irkupru inkrementali [(IU/dL)/(IU/kg)]
English: Common side effects (may affect up to 1 in 10 people) Headache, nausea, diarrhoea, rash
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn 10) uġigħ ta' ras, dardir, dijarea, raxx
English: ADYNOVI contains the active substance rurioctocog alfa pegol, pegylated human coagulation factor VIII.
Maltese: ADYNOVI fih is-sustanza attiva rurioctocog alfa pegol, fattur VIII pegilat tal-koagulazzjoni talbniedem.
English: 1 powder vial, 1 vial with 5 ml solvent, 1 BAXJECT II Hi-Flow device.
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni 1 kunjett bit-trab, 1 kunjett b'solvent ta' 5 mL, apparat BAXJECT II HI-FLOW 1.
English: Pharmacokinetic parameters calculated from 39 subjects less than 18 years of age (intent-to-treat analysis) are available for 14 children (2 to less than 6 years), 17 older children (6 to less than 12 years) and 8 adolescent subjects (12 to < 18 years of age).
Maltese: Il-parametri farmakokinetiċi kkalkulati minn 39 individwu ta' anqas minn 18-il sena (analiżi bl-iskop li tikkura) huma disponibbli għal 14-il tifel u tifla (sentejn sa inqas minn 6 snin), 17-il tifel u tifla akbar (6 sa inqas minn 12-il sena) u 8 individwi adolexxenti (12 sa < 18-il sena).
English: - The other ingredients are mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80 and sterilised water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma mannitol, trehalose di-hydrate, histidine, glutathion, sodium chloride, calcium chloride di-hydrate, tris(hydroxymethyl)aminomethane, polysorbate 80 u ilma sterilizzat għall-injezzjonijiet.
English: Table 2: Adverse reactions reported for ADYNOVI
Maltese: Tabella 2: Reazzjonijiet avversi rrappurtati għal ADYNOVI Sistema tal-Klassifika tal-Organi
English: This medicine contains 0.45 mmol sodium (10 mg) per vial.
Maltese: Dan il-prodott mediċinali fih 0.45 mmol ta' sodium (10 mg) f'kull kunjett.
English: Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għall-molekula ġenitur octocog alfa jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
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 għallMediċini: http://www.ema.europa.eu/
English: Twenty four out of 65 subjects (37%) experienced no bleeding episodes, 47 out of 65 subjects (72%) experienced no joint bleeding episodes, and 43 out of 65 subjects (66%) experienced no spontaneous bleeding episodes on prophylaxis.
Maltese: Erbgħa u għoxrin minn 65 individwu (37%) ma esperjenzaw l-ebda episodju ta' fsada, 47 minn 65 individwu (72%) ma esperjenzaw l-ebda episodju ta' fsada fil-ġogi, u 43 minn 65 individwu (66%) ma esperjenzaw l-ebda episodju ta' fsada spontanja fuq il-profilassi.
English: * Human factor VIII produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line.
Maltese: * Fattur uman VIII jiġi prodott minn teknoloġija tad-DNA rikombinanti fil-linja taċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO).
English: 1 powder vial, 1 vial with 2 ml solvent, 1 BAXJECT II Hi-Flow device.
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni 1 kunjett bit-trab, 1 kunjett b'solvent ta' 2 mL, apparat BAXJECT II HI-FLOW 1.
English: Including tooth extraction.
Maltese: Inkluż l-estrazzjoni tas-snien.
English: Paediatric Pharmacokinetics
Maltese: .1 Proprjetajiet farmakodinamiċi
English: These could be early symptoms of anaphylactic shock; additional symptoms may include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
Maltese: Dawn is-sintomi jistgħu jkunu sintomi bikrin ta' xokk anafilattiku; sintomi addizzjonali jistgħu jinkludu sturdament estrem, telfien mis-sensi, u diffikultà estrema biex tieħu n-nifs.
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 diretti lejn l-attività prokoagulanti tal-fattur VIII, li jiġu kwantifikati f'Unitajiet Bethesda (BU) għal kull mL ta' plażma billi tintuża l-analiżi modifikata (modified assay).
English: Excipient(s) with known effect Each powder vial contains 0.45 mmol (10 mg) sodium, see section 4.4.
Maltese: Eċċipjent(i) b'effett magħruf Din il-mediċina fiha 0.45 mmol ta' sodium (10 mg) f'kull kunjett tat-trab, ara sezzjoni 4.4.
English: A total of 66 PTPs with severe haemophilia A were dosed (32 subjects aged < 6 years and 34 subjects aged 6 to < 12 years) in the paediatric study.
Maltese: Fl-istudju pedjatriku, total ta' 66 PTPs b'emofilja A severa ngħataw id-doża (32 individwu li kellhom < 6 snin u 34 individwu li kellhom 6 sa < 12-il sena).
English: Control of bleeding was rated excellent (full relief of pain and cessation of objective signs of bleeding after a single infusion) or good (definite pain relief and/or improvement in signs of bleeding after a single infusion) in 63 out of 70 (90.0%) bleeding episodes.
Maltese: Il-kontroll tal-fsada kien ikklassifikat bħala eċċellenti (solliev sħiħ mill-uġigħ u waqfien ta' sinjali oġġettivi ta' fsada wara infużjoni waħda) jew tajjeb (solliev mill-uġigħ definit u/jew titjib fis-sinjali ta' fsada wara infużjoni waħda) fi 63 minn 70 (90.0%) episodju ta' fsada.
English: Do not refrigerate.
Maltese: Aħżen fi friġġ.
English: The medicinal product is provided in one of the following configurations:
Maltese: Il-prodott mediċinali jiġi pprovdut f'waħda mill-konfigurazzjonijiet li ġejjin:
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Maltese: Tabella 1 Gwida għad-dożaġġ f'episodji ta' fsada u kirurġija Grad ta' emorraġija/tip ta' proċedura kirurġika
English: ADYNOVI has an extended half-life of 1.4 to 1.5-fold compared to recombinant human coagulation factor VIII (octocog alfa) in the adolescent and adult population, as determined based on one stage clotting and chromogenic assays, respectively.
Maltese: ADYNOVI għandu half-life estiża ta' 1.4 sa 1.5 drabi meta mqabbel mal-fattur VIII tal-koagulazzjoni tal-bniedem rikombinanti ta' tul sħiħ (octocog alfa) fil-popolazzjoni tal-adolexxenti u l-adulti, kif determinat abbażi tal-assaġġi ta' koagulazzjoni ta' stadju wieħed u dawk kromoġeniċi, rispettivament.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari eżistenti, terapija ta' sostituzzjoni b'fattur VIII tista' żżid ir-riskju kardjovaskulari.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma ġiet irrappurtata l-ebda interazzjoni ta' prodotti tal-fattur VIII tal-koagulazzjoni tal-bniedem (rDNA) ma' prodotti mediċinali oħrajn.
English: A total of 137 male PTPs (12 to 65 years of age) with severe haemophilia A received at least one infusion with ADYNOVI.
Maltese: Total ta' 137 PTPs irġiel (12 sa 65 sena) b'emofilja A severa rċevew mill-inqas infużjoni waħda b'ADYNOVI.
English: Of these, 361 bleeding episodes (n=17 subjects) occurred in the on-demand arm and 157 (n=61 subjects) occurred in the prophylaxis arm.
Maltese: Minn dawn, 361 episodju ta' fsada (m= 17-il suġġett) seħħew fil-fergħa ta' skont il-bżonn u 157 (n=61 suġġett) seħħew fil-fergħa tal-profilassi.
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: Hu indispensabbli li fil-każ ta' interventi kirurġiċi maġġuri, ikun hemm osservazzjoni preċiża tat-terapija ta' sostituzzjoni, permezz tal-analiżi ta' koagulazzjoni (l-attivà tal-fattur VIII fil-plażma).
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Maltese: Il-kumpless tal-Fattur VIII/fattur von Willebrand jikkonsisti minn żewġ molekuli (il-fattur VIII u lfattur von Willebrand) b'funzjonijiet fiżjoloġiċi differenti.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L­MAH għandu jwettaq l­attivitajiet u l­interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The therapeutic activity of rurioctocog alfa pegol is derived from octocog alfa, which is produced by recombinant DNA technology from a Chinese hamster ovary cell line.
Maltese: L-attività terapewtika ta' rurioctocog alfa pegol hija derivata minn octocog alfa, li huwa prodott minn teknoloġija b'DNA rikombinanti minn linja ta' ċelluli ovarji tal-ħamster Ċiniż.
English: For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Maltese: Għal pazjenti li kienu kkurati qabel b'Fattur VIII (aktar minn 150 jum ta' kura), antikorpiinibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod mhux komuni (inqas minn pazjent 1 minn kull 100).
English: Prophylactic treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: Allergic type hypersensitivity reactions are possible with ADYNOVI.
Maltese: Reazzjonijiet ta' sensittività eċċessiva ta' tip allerġiku huma possibbli b'ADYNOVI.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection 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: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjodema, ħruq u tingiż fis-sit talinjezzjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, nawsja, irrikwetezza, takikardija, tagħfis tas-sider, tnemnim, rimettar, tħarħir) ġew osservati rarament u jistgħu f'xi każijiet javvanzaw għal anafilassi severa (inkluż xokk).
English: NA, Not applicable, as Incremental Recovery and Cmax in children were determined by individual PK.
Maltese: NA, Mhux Applikabbli, peress li l-Irkupru Inkrementali u s-Cmass fit-tfal ġew determinati minn PK individwali.
English: Use of a Luer-lock syringe is recommended.
Maltese: Luer-lock.
English: Individual PK with full sampling a
Maltese: PK individwali b'kampjunar sħiħ a
English: The median joint ABR (Q1 ; Q3) in the on-demand arm was 38.1 (24.5 ; 44.6) compared to 0.0 (0.0 ; 2.0) while on prophylaxis, and the median spontaneous ABR was 21.6 (11.2 ; 33.2) on the on-demand arm compared to 0.0 (0.0 ; 2.2) while on prophylaxis.
Maltese: L-ABR konġunta medjana (Q1; Q3) fil-fergħa skont il-bżonn kienet 38.1 (24.5; 44.6) mqabbla ma' 0.0
English: Of the 518 bleeding episodes, 96.1% were rated excellent (full relief of pain and cessation of objective signs of bleeding after a single infusion) or good (definite pain relief and/or improvement in signs of bleeding after a single infusion) in their response to treatment with ADYNOVI.
Maltese: Mill-518-il episodju ta' fsada, 96.1% kienu kklassifikati bħala eċċellenti (solliev sħiħ mill-uġigħ u waqfien ta' sinjali oġġettivi ta' fsada wara infużjoni waħda) jew tajbin (solliev mill-uġigħ definit u/jew titjib fis-sinjali ta' fsada wara infużjoni waħda) fir-rispons tagħhom għall-kura b'ADYNOVI.
English: OUTER CARTON (BAXJECT III SYSTEM)
Maltese: TIKKETTA TAL-IMMUNTAR (SISTEMA BAXJECT III)
English: Connect the syringe to BAXJECT III.
Maltese: Qabbad is-siringa malapparat BAXJECT III.
English: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Maltese: - raxx, ħorriqija, wheals, ħakk ġeneralizzat, - nefħa tax-xufftejn u l-ilsien - diffikultà biex tieħu n-nifs, tħarħir, tagħfis fis-sider, - sensazzjoni ġenerali li ma tħossokx tajjeb/tajba, - sturdament u tintilef minn sensik.
English: Haemophilia A is a X-chromosomal linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Maltese: L-emofilja A hija disturb ereditarju marbut mal-kromożoma X ta' koagulazzjoni tad-demm minħabba livelli mnaqqsa tal-fattur VIII:C u dan jirriżulta fi fsada abbundanti fil-ġogi, fil-muskoli jew fl-organi interni, jew b'mod spontanju jew b'riżultat ta' trawma aċċidentali jew kirurġika.
English: VIAL LABEL FOR THE SOLVENT (BAXJECT II HI-FLOW DEVICE)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT GĦAS-SOLVENT (APPARAT BAXJECT II HI-FLOW)
English: Open the BAXJECT II Hi-Flow device package by peeling away the lid, without touching the inside (Figure A).
Maltese: Iftaħ il-pakkett tal-apparat BAXJECT II Hi-Flow billi tqaxxar l-għatu, mingħajr ma tmiss ġewwa (Figura A).
English: PHARMACEUTICAL PARTICULARS
Maltese: Farmakokinetika pedjatrika
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 meħtieġ apparat ta' aċċess venuż ċentrali (CVAD - central venous access device), għandu jiġi kkunsidrat ir-riskju ta' kumplikazzjonijiet relatati mas-CVAD, inkluż infezzjonijiet lokali, batteremija u trombożi fis-sit tal-kateter.
English: The safety of ADYNOVI was evaluated in 243 previously treated patients with severe haemophilia A (factor VIII less than 1% of normal), who received at least one dose of ADYNOVI in 3 completed multi-center, prospective, open label clinical studies and 2 ongoing clinical studies.
Maltese: Is-sigurtà ta' ADYNOVI ġiet evalwata f'243 pazjent b'emofilja A severa (fattur VIII inqas minn 1% tan-normal) li ġew ikkurati qabel, li rċevew mill-inqas doża waħda ta' ADYNOVI fi 3 studji kliniċi mitmuma multiċentriċi, prospettivi u open label u 2 studji kliniċi li għadhom għaddejjin.
English: A total of 518 bleeding episodes were treated with ADYNOVI in the per-protocol population.
Maltese: Fil-popolazzjoni skont il-protokoll ġew ikkurati total ta' 518-il episodju ta' fsada b'ADYNOVI.
English: The vacuum will draw the solvent into the powder vial.
Maltese: Soluzzjoni ċara u mingħajr kulur.
English: Do not touch the exposed purple plastic spike.
Maltese: Tmissx il-ponta talplastik vjola esposta.
English: Each powder vial contains nominally 250, 500,
Maltese: Kull kunjett bit-trab fih nominalment 250, 500, 1000, jew 2000
English: - The solvent vial contains 5 ml of sterilised water for injections.
Maltese: - Il-kunjett bis-solvent fih 5 mL ta' ilma sterilizzat għall-injezzjonijiet.
English: The PEG moiety is conjugated to octocog alfa to increase the plasma half-life.
Maltese: Il-frazzjoni PEG hija kkonjugata għall-octocog alfa biex tiżdied il-half-life talplażma.
English: The solvent vial has a blue stripe.
Maltese: Ilkunjett tas-solvent għandu strixxa bajda.
English: Solvent Sterilised water for injections
Maltese: Ilma sterilizzat għall-injezzjonijiet
English: Rurioctocog alfa pegol, is a pegylated recombinant human factor VIII with an extended half-life.
Maltese: Rurioctocog alfa pegol, huwa fattur VIII pegilat tal-bniedem rikombinanti b'half-life estiża.
English: For major surgeries, the preoperative loading dose ranged from 36 IU/kg to 109 IU/kg (median: 63 IU/kg); and postoperative total dose ranged from 186 IU/kg to 1320 IU/kg (median: 490 IU/kg).
Maltese: IU/kg sa 1320 IU/kg (medjan: 490 IU/kg).
English: OUTER CARTON (BAXJECT II HI-FLOW DEVICE)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT BIT-TRAB (APPARAT BAXJECT II HI-FLOW)
English: Powder and solvent vials preassembled in BAXJECT III system.
Maltese: Kunjetti bit-trab u bis-solvent immuntati minn qabel f'sistema BAXJECT III.
English: Verify that the solvent transfer is complete.
Maltese: Ivverifika li t-trasferiment tas-solvent ikun tlesta.