FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, adverse reaction rates were highest in induction and titration phases (time prior to reaching blood phenylalanine levels less than 600 micromol/l while on a stable dose) coinciding with the period when titres of IgM and anti-PEG antibodies were highest.
Maltese: Fi provi kliniċi, ir-rati ta' reazzjoni avversa kienu l-ogħla fil-fażijiet tal-induzzjoni u t-titrazzjoni (iż-żmien qabel ma jintlaħqu l-livelli ta' phenylalanine fid-demm kien inqas minn 600 micromol/L waqt li fuq doża stabbli) li jikkoinċidu mal-perjodu meta t-titres ta' antikorpi IgM u kontra l-PEG kienu l-ogħla.
English: Step 12: Use a quick motion to fully insert the needle into the pinched skin at a 45 to 90 degree angle (see Figure L).
Maltese: Pass 12: Uża moviment mgħaġġel biex iddaħħal l-labra kollha fil-ġilda maqrusa f'angolu ta' 45 sa 90 grad (ara Figura L).
English: Each 10 mg pre-filled syringe contains 10 mg pegvaliase in 0.5 ml solution.
Maltese: Kull siringa mimlija għal-lest ta' 10 mg fiha 10 mg ta' pegvaliase f'soluzzjoni ta' 0.5 mL.
English: The mean duration of arthralgia was 15 days and ranged 1 day to 936 days; 78% of arthralgia episodes had a duration of less than 14 days, and 1% of arthralgia episodes persisted at least 180 days.
Maltese: Id-dewmien medju tal-artralġija kien ta' 15-il jum u varja minn jum sa 936 jum; 78% tal-episodji tal-artralġija damu inqas minn 14-il jum, u 1% tal-episodji tal-artralġija ppersistew mill-inqas 180 jum. 14-il pazjent (5%) kellhom artralġija severa (uġigħ sever li jillimita attivitajiet tal-kura personali tal-ħajja ta' kuljum).
English: Patients should be monitored every 2 weeks until blood phenylalanine levels are within a clinically acceptable range (see section 4.4, Hypophenylalaninaemia).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati kull ġimagħtejn sakemm il-livelli ta' phenylalanine fid-demm jkunu f'medda klinikament aċċettabbli (ara sezzjoni 4.4, Livelli baxxi ta' phenylalanine fid-demm).
English: Each 20 mg pre-filled syringe contains 20 mg pegvaliase in 1 ml solution.
Maltese: Kull siringa mimlija għal-lest ta' 20 mg fiha 20 mg ta' pegvaliase f'soluzzjoni ta' 1 mL.
English: You may have blood phenylalanine levels that are too low when using Palynziq.
Maltese: Jista' jkollok livelli ta' phenylalanine fid-demm baxxi wisq meta tkun qed tuża Palynziq.
English: In clinical trials, 241 out of 285 (85%) patients experienced episodes consistent with arthralgia (including back pain, musculoskeletal pain, pain in extremity, and neck pain).
Maltese: Artralġija u sinjali u sintomi oħra relatati mal-ġogi Fi provi kliniċi, 241 minn 285 (85%) pazjent kellhom episodji konsistenti mal-artralġija (li jinkludu wġigħ fid-dahar, uġigħ muskoluskeletriku, uġigħ fl-estremitajiet, u wġigħ fl-għonq).
English: 16 weeks2
Maltese: 16-il ġimgħa2
English: Palynziq-treated patients were able to maintain their blood phenylalanine reductions compared to the placebo patients whose blood phenylalanine levels returned to their pre-treatment baseline levels after 8 weeks (p < 0.0001, see Table 3).
Maltese: Pazjenti ttrattati b'Palynziq setgħu jżommu t-tnaqqis tagħhom tal-phenylalanine fid-demm meta mqabbla mal-pazjenti fuq il-plaċebo, liema livelli ta' phenylalanine fid-demm marru lura għal-livelli tagħhom fil-linja bażi ta' qabel it-trattament wara 8 ġimgħat (p < 0.0001, ara Tabella 3).
English: Acute systemic hypersensitivity reactions
Maltese: Reazzjoni ta' sensittività eċċessiva sistemika akuta³
English: Acute systemic hypersensitivity reactions require treatment with adrenaline and immediate medical care.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti jeħtieġu trattament bl-adrenalina u kura medika immedjata.
English: Pre-filled syringe 10 mg (green plunger): Each 10 mg carton contains 1 pre-filled syringe.
Maltese: Siringa mimlija għal-lest ta' 10 mg (planġer aħdar): Kull kartuna ta' 10 mg fiha siringa waħda mimlija għal-lest.
English: Starting Palynziq
Maltese: Kif taħżen Palynziq
English: Do not use this medicine after the expiry date which is stated on the syringe label, tray cover, and carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tas-siringa, l-għatu tat-trej, u l-kartuna wara “EXP”.
English: Of the 11 patients initially enrolled in Study 301, 3 patients reached blood phenylalanine levels ≤ 600 micromol/l by 12 months, 7 patients reached this threshold by 24 months, and 8 patients reached this threshold by 36 months.
Maltese: Mill-11-il pazjent li kienu fil-bidu rreġistraw fi Studju 301, 3 pazjenti laħqu livelli ta' phenylalanine fid-demm ta' ≤ 600 micromol/L sa 12-il xahar, 7 pazjenti laħqu dan il-livell limitu sa 24 xahar, u 8 pazjenti laħqu dan il-livell limitu sa 36 xahar.
English: The risk of a hypersensitivity reaction occurring is 2.6-fold higher in induction/titration phase compared to maintenance phase.
Maltese: Ir-riskju li sseħħ reazzjoni ta' sensittività eċċessiva hija 2.6 drabi ogħla fil-fażi ta' induzzjoni/titrazzjoni meta mqabbel mal-fażi tal-manteniment.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palynziq 10 mg injection pegvaliase
Maltese: U MNEJN GĦANDU JINGĦATA Injezzjoni ta' Palynziq 10 mg pegvaliase
English: 4 weeks2
Maltese: 4 ġimgħat2
English: The mean duration of injection site reaction was 9 days, and ranged 1 day to 970 days; 91% of injection site reactions had a duration of less than 14 days, 0.8% of injection site reactions persisted at least 180 days, and 99% of injection site reactions resolved by the time of the data cut-off.
Maltese: Id-dewmien medju tar-reazzjonijiet fis-sit talinjezzjoni kien ta' 9 ijiem, u kien ivarja minn jum wieħed sa 970 jum; 91% tar-reazzjonijiet fis-sit talinjezzjoni damu inqas minn 14-il jum, 0.8% tar-reazzjonijiet ta' sensittività eċċessiva ppersistew għal mill-inqas 180 jum, u 99% tar-reazzjonijiet fis-sit talinjezzjoni fiequ saż-żmien tal-għeluq tal-ġbir tad-dejta.
English: The mean duration of hypersensitivity reactions was 7 days, and ranged less than 1 day to 227 days; 89% of hypersensitivity reactions had a duration of less than 14 days, 0.4% of hypersensitivity reactions persisted at least 180 days, and 99% of hypersensitivity reactions resolved by the time of the data cut-off.
Maltese: Id-dewmien medju tar-reazzjonijiet ta' sensittività eċċessiva kien ta' 7 ijiem, u kien ivarja sa minn inqas minn jum wieħed għal 227 jum; 89% tar-reazzjonijiet ta' sensittività eċċessiva damu inqas minn 14-il jum, 0.4% tar-reazzjonijiet ta'
English: More pressure may be needed to inject all the medicine for the 10 mg and 20 mg strengths.
Maltese: Jaf ikun hemm bżonn ta' aktar pressjoni biex tinjetta l-mediċina kollha għall-qawwiet ta' 10 mg u 20 mg.
English: Of the 100 patients who discontinued treatment, 40 patients discontinued due to an adverse event, 29 patients discontinued due to patient decision, 10 patients discontinued due to physician decision, and 21 patients discontinued to other reasons (e.g. lost to follow-up, pregnancy, or protocol deviation).
Maltese: Mill-100 pazjent li waqqfu t-trattament, 40 pazjent waqfu minħabba avveniment avvers, 29 pazjent waqfu minħabba deċiżjoni tal-pazjent, 10 pazjenti waqfu minħabba deċiżjoni tat-tabib, u 21 pazjent waqfu għal raġunijiet oħra (eż., persuna li tirtira, tqala, jew devjazzjoni mill-protokoll).
English: During titration and maintenance of Palynziq treatment, patients may develop blood phenylalanine levels below 30 micromol/l.
Maltese: Matul it-titrazzjoni u l-manteniment tat-trattament ta' Palynziq, il-pazjenti jistgħu jiżviluppaw livelli ta' phenylalanine fid-demm aktar baxxi minn 30 micromol/L.
English: In clinical trials, 133 out of 285 (47%) patients treated with Palynziq experienced cutaneous reactions (not limited to the injection site) lasting at least 14 days.
Maltese: Reazzjonijiet tal-ġilda (mhux limitati għas-sit tal-injezzjoni) li damu ≥ 14-il jum Fi provi kliniċi, 133 minn 285 (47%) pazjent ittrattati b'Palynziq kellhom reazzjonijiet tal-ġilda (mhux limitati għas-sit tal-injezzjoni) li damu mill-inqas 14-il jum.
English: Subcutaneous use
Maltese: Effett tal-esponiment
English: Angioedema was most frequent during induction and titration phase (6% of patients; 27 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (3% of patients; 10 episodes over mean treatment duration of 28 months).
Maltese: L-anġjoedema kienet l-aktar frekwenti matul il-fażi tal-induzzjoni u t-titrazzjoni (6% tal-pazjenti; 27 episodju fuq tul ta' żmien tat-trattament medju ta' 12-il xahar) u naqsu fil-fażi tal-manteniment (3% tal-pazjenti; 10 episodji fuq tul ta' żmien tat-trattament medju ta' 28 xahar).
English: The risk of angioedema occurring is 4.5-fold higher in induction/titration phase compared to maintenance phase.
Maltese: Ir-riskju li sseħħ anġjoedema hija 4.5 drabi ogħla fil-fażi ta' induzzjoni/titrazzjoni meta mqabbel mal-fażi tal-manteniment.
English: 10 mg and 20 mg pre-filled syringe:
Maltese: 2.5 mg, 10 mg, and 20 mg.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palynziq 20 mg injection pegvaliase
Maltese: U MNEJN GĦANDU JINGĦATA Injezzjoni ta' Palynziq 20 mg pegvaliase
English: Study 301 an open-label randomised (1:1), multi-centre study of patients with PKU to assess the safety and tolerability of self-administered Palynziq in an induction/titration/maintenance dose regimen.
Maltese: Studju 301: Il-bidu tat-trattament (Induzzjoni u Titrazzjoni) Studju 301, studju open-label, multiċentriku, fejn il-pazjenti ntgħażlu b'mod każwali (1:1) dwar pazjenti b'PKU biex jiġu evalwati s-sigurtà u t-tollerabilità ta' Palynziq li jingħata mill-pazjent innifsu fi skeda tad-doża tal-induzzjoni/titrazzjoni/manteniment.
English: Management of hypersensitivity reactions should be based on the severity of the reaction; in clinical trials, this has included dose adjustment, treatment interruption, additional antihistamines, antipyretics, and/or corticosteroids.
Maltese: L-immaniġġjar tar-reazzjonijiet ta' sensittività eċċessiva għandu jkun ibbażat fuq is-severità tar-reazzjoni; fi provi kliniċi, dan kien jinkludi aġġustament tad-doża, interruzzjoni tat-trattament, antistamini addizzjonali, antipiretiċi, u/jew kortikosterojdi.
English: Therefore, a reduction in pegvaliase dose should be considered in patients experiencing hypophenylalaninaemia despite appropriate levels of protein intake (see section 4.2).
Maltese: Għalhekk, għandu jiġi kkunsidrat tnaqqis fid-doża ta' pegvaliase f'pazjenti li jkollhom livelli baxxi ta' phenylalanine fid-demm minkejja livelli xierqa ta' konsum tal-proteina (ara sezzjoni 4.2).
English: ADHD inattention and PKU-POMS confusion over time
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: Palynziq 20 mg solution for injection in pre-filled syringe pegvaliase
Maltese: Palynziq 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest pegvaliase
English: Dose was not changed for 23 (96%) episodes and dose was reduced for 1 (4%) episode.
Maltese: Id-doża ma ġietx mibdula għal 23 (96%) episodju u d-doża ġiet imnaqqsa għal episodju wieħed (4%).
English: Let the skin air dry for at least 10 seconds before injecting (see Figure H).
Maltese: Ħalli l-ġilda tinxef għal mill-inqas 10 sekondi qabel tinjetta (ara Figura H).
English: Three of these patients experienced severe serum sickness (3/285; 1%), which resulted in treatment discontinuation (2 patients) or treatment interruption (1 patient).
Maltese: Tlieta minn dawn il-pazjenti kellhom mard tas-serum sever (3/285; 1%), li rriżulta fit-twaqqif tat-trattament (2 pazjenti) jew interruzzjoni tat-trattament (pazjent wieħed).
English: Maternal blood phenylalanine levels must be strictly controlled between 120 and 360 micromol/l both before and during pregnancy.
Maltese: Il-livelli ta' phenylalanine fid-demm tal-omm iridu jiġu kkontrollati b'mod strett bejn 120 u 360 micromol/L kemm qabel u matul it-tqala.
English: Neutralising antibodies (NAb) capable of inhibiting PAL enzyme activity were detected in a majority of patients over time with 78% of patients testing positive for NAb at one year after treatment initiation and maintaining stable NAb titres through long-term treatment.
Maltese: Kienu identifikati antikorpi newtralizzanti (NAb, neutralising antibodies) li għandhom il-kapaċità jinibixxu attività tal-enzimi ta' PAL fil-maġġoranza tal-pazjenti fuq perjodu ta' żmien b'78% tal-pazjenti jkollhom test b'riżultat pożittiv għal NAb wara sena mill-bidu tat-trattamanet u jżommu titres ta' NAb stabbli permezz ta' trattament fit-tul.
English: Serum sickness3
Maltese: Mard tas-serum
English: Of these 188 patients, 164 patients received treatment for at least 2 years, 2 patients continued treatment but had not yet reached 2 years of treatment, and 22 patients discontinued in the second year, and 9 patients discontinued after 2 years of treatment.
Maltese: Minn dawn il-188 pazjent, 164 pazjent irċivew trattament għal mill-inqas sentejn, żewġ pazjenti komplew it-trattament iżda ma kinux għadhom laħqu sentejn ta' trattament, u 22 pazjent waqfu fit-tieni sena, u 9 pazjenti waqfu wara sentejn ta' trattament.
English: Table 2 provides adverse reactions in patients treated with Palynziq.
Maltese: Tabella 2 tipprovdi reazzjonijiet avversi fil-pazjenti ttrattati b'Palynziq.
English: Marketing Authorisation Holder and Manufacturer BioMarin International Limited Shanbally, Ringaskiddy
Maltese: FIS-SUQ BioMarin International Limited
English: ADHD inattention3 subscale (investigator-rated)
Maltese: Sottoskala ta' distrazzjoni ta' ADHD³ (ikklassifikata mill-investigatur) N
English: The dose should be escalated gradually based on tolerability to the daily maintenance dose required to achieve blood phenylalanine level of 120 to 600 micromol/l according to Table 1.
Maltese: Id-doża għandha tiżdied b'mod gradwali abbażi tat-tollerabilità għad-doża ta' manteniment ta' kuljum meħtieġa biex jinkiseb livell ta' phenylalanine fid-demm ta' 120 sa 600 micromol/L skont it-Tabella 1.
English: Palynziq 2.5 mg solution for injection in pre-filled syringe Palynziq 10 mg solution for injection in pre-filled syringe Palynziq 20 mg solution for injection in pre-filled syringe pegvaliase
Maltese: Il-pazjenti bdew it-trattament b'Palynziq b'kors tal-induzzjoni (2.5 mg darba fil-ġimgħa għal 4 ġimgħat) u kienu ttitrati b'mod pass pass (doża u frekwenza miżjuda) biex jilħqu d-doża fil-mira magħżula b'mod każwali ta' 20 mg darba kuljum jew 40 mg darba kuljum.
English: In clinical trials, a direct correlation between pegvaliase plasma exposure and blood phenylalanine reduction was observed.
Maltese: Fi provi kliniċi, kienet osservata korrelazzjoni diretta bejn l-esponiment għal pegvaliase fil-plażma u t-tnaqqis ta' phenylalanine fid-demm.
English: 1 If blood phenylalanine levels are below 30 micromol/l, dietary protein intake should be increased to appropriate levels, and then, if needed, the dose of Palynziq should be reduced (see section 4.4, Hypophenylalaninaemia).
Maltese: 1 Jekk il-livelli ta' phenylalanine fid-demm ikunu taħt 30 micromol/L, il-konsum fid-dieta tal-proteina għandu jiżdied għal-livelli xierqa, u mbagħad, jekk meħtieġ, id-doża ta' Palynziq għandha tiġi mnaqqsa (ara sezzjoni 4.4, Livelli baxxi ta' phenylalanine fid-demm).
English: • gauze pad or cotton ball
Maltese: • pad tal-garża jew ballun tat-tajjar
English: Patients usually need a daily dose of 20 mg, 40 mg, or 60 mg to reach their target blood phenylalanine level.
Maltese: Normalment il-pazjenti jkollhom bżonn doża ta' kuljum ta' 20 mg, 40 mg, jew 60 mg biex jilħqu l-livell ta' phenylalanine fid-demm fil-mira tagħhom.
English: Acute systemic hypersensitivity reactions were most frequent during induction and titration phase (5% of patients; 19 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (2% of patients; 6 episodes over mean treatment duration of 28 months).
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti kienu l-aktar frekwenti matul il-fażi tal-induzzjoni u t-titrazzjoni (5% tal-pazjenti; 19-il episodju fuq tul ta' żmien tat-trattament medju ta' 12-il xahar) u naqsu fil-fażi tal-manteniment (2% tal-pazjenti; 6 episodji fuq tul ta' żmien tat-trattament medju ta' 28 xahar).
English: Look at the liquid through the viewing window (see Figure D).
Maltese: Ħares lejn il-likwidu minn ġot-tieqa tal-ispezzjoni (ara Figura D).
English: Hypophenylalaninaemia
Maltese: Trometamol hydrochloride
English: Of the 5 serum sickness episodes where time to onset was evaluable, 1 episode occurred within 1 hour of injection and 4 episodes occurred between 24 hours and up to 5 days following injection.
Maltese: Mill-5 episodji ta' mard tas-serum fejn iż-żmien għall-bidu tagħhom seta' jiġi evalwat, seħħ episodju wieħed fi żmien siegħa mill-injezzjoni u seħħew 4 episodji bejn 24 siegħa u sa 5 ijiem mill-injezzjoni.
English: Results for PKU-POMS confusion subscale over time are shown in Table 4.
Maltese: Ir-riżultati tas-sottoskala ta' konfużjoni ta' PKU-POMS maż-żmien huma murija f'Tabella 4.
English: Hypersensitivity reactions decreased over time in maintenance as the incidence of these antibodies decreased, and C3/C4 returned towards baseline.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva naqsu maż-żmien matul il-manteniment hekk kif l-inċidenża ta' dawn l-antikorpi naqset, u s-C3/C4 marru lura għal-linja bażi.
English: ADHD inattention3 subscale (investigator-rated) with baseline score > 9
Maltese: Sottoskala ta' distrazzjoni ta' ADHD³ (ikklassifikata mill-investigatur) b'punteġġ fil-linja bażi
English: 2.5 mg twice weekly
Maltese: 2.5 mg darbtejn fil-ġimgħa ġimgħa2
English: Patients in the 20 mg once daily randomised arm reached their maintenance dose at a median time of 10 weeks (range: 9 to 29 weeks) and patients in the 40 mg once daily arm reached their maintenance dose at a median time of 11 weeks (range: 10 to 33 weeks).
Maltese: Il-pazjenti fil-parti tal-istudju ta' 20 mg darba kuljum magħżula b'mod każwali laħqu d-doża ta' manteniment fi żmien medjan ta' 10 ġimgħat (medda: 9 sa 29 ġimgħa) u pazjenti fil-parti tal-istudju ta' 40 mg darba kuljum laħqu d-doża ta' manteniment tagħhom fi żmien medjan ta' 11-il ġimgħa (medda: 10 sa 33 ġimgħa).
English: Individual values for half-life range from 14 to 132 hours.
Maltese: Il-valuri individwali għall-half-life jvarjaw minn 14 sa 132 siegħa.
English: Time to response (achieving blood phenylalanine levels ≤ 600 micromol/l) varies among patients.
Maltese: Iż-żmien għar-rispons (biex jintlaħqu livelli ta' phenylalanine fid-demm ta' ≤ 600 micromol/L) ivarja fost il-pazjenti.
English: 2.5 mg once a week 2.5 mg two times a week
Maltese: 2.5 mg darba fil-ġimgħa 2.5 mg darbtejn fil-ġimgħa
English: 2 Based on the mixed model repeated measures (MMRM) method, with treatment arm, visit, and treatment arm-by-visit interaction (the time profile of blood phenylalanine changes is assessed separately for each treatment arm) as factors adjusting for baseline blood phenylalanine concentration.
Maltese: 2 Abbażi tal-metodu tal-mudell imħallat għal miżuri ripetuti (MMRM, mixed model repeated measures), bil-parti tal-istudju tat-trattament, żjara, u l-parti tal-istudju tat-trattament skont l-interazzjoni taż-żjara (il-profil taż-żmien tal-bidliet tal-phenylalanine fid-demm jiġi evalwat b'mod separat għal kull parti tal-istudju tat-trattament) bħala fatturi li jaġġustaw ruħhom għall-konċentrazzjoni fil-linja bażi tal-phenylalanine fid-demm.
English: Due to the potential for an acute systemic hypersensitivity reaction, premedication prior to each dose is required during induction and titration (time prior to reaching blood phenylalanine levels less than 600 micromol/l while on a stable dose; see section 4.8).
Maltese: Minħabba l-potenzjal għal reazzjoni ta' sensittività eċċessiva sistemika akuta, hija meħtieġa medikazzjoni qabel kull doża matul l-induzzjoni u t-titrazzjoni (iż-żmien qabel ma jintlaħqu l-livelli ta' phenylalanine fid-demm ta' inqas minn 600 micromol/L waqt li fuq doża stabbli; ara sezzjoni 4.8).
English: After 6 months of Palynziq treatment, the need for an observer may be reconsidered.
Maltese: Wara 6 xhur ta' trattament b'Palynziq, il-ħtieġa għal osservatur tista' terġa' tiġi kkunsidrata.
English: Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
Maltese: Palynziq huwa indikat għat-trattament ta' pazjenti b'fenilketonurija (PKU, phenylketonuria) li jkollhom 16-il sena jew aktar u li jkollhom kontroll mhux adegwat ta' phenylalanine fid-demm (il-livelli ta' phenylalanine fid-demm ikunu ogħla minn 600 micromol/L) minkejja li qabel kien sar immaniġġjar bl-għażliet tat-trattament disponibbli.
English: All 11 patients had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) at baseline.
Maltese: Il-11-il pazjent kollha kellhom kontroll mhux adegwat tal-phenylalanine fid-demm (livelli ta' phenylalanine fid-demm ogħla minn 600 micromol/L) fil-linja bażi.
English: 2 Hypersensitivity reactions cover a group of terms, including acute systemic hypersensitivity reactions, and can manifest as a range of symptoms including angioedema, serum sickness, rash, and urticaria.
Maltese: sensittività eċċessiva sistemiċi akuti, u jistgħu jimmanifestaw bħala firxa ta' sintomi li jinkludu anġjoedema, mard tas-serum, raxx, u urtikarja.
English: Phenylalanine levels over time
Maltese: Livelli baxxi ta' phenylalanine fid-demm
English: • Physician educational material • Patient information pack
Maltese: • Materjal edukattiv tat-tabib • Pakkett ta' tagħrif għall-pazjent
English: * Anabaena variabilis rAvPAL produced by recombinant DNA technology in Escherichia coli.
Maltese: • Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni;
English: EU/1/19/1362/001 2.5 mg pre-filled syringe
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1362/001 siringa mimlija għal-lest ta' 2.5 mg
English: White plunger
Maltese: KIF TINJETTA
English: Angioedema can also present as one of the symptoms of an acute systemic hypersensitivity reaction.
Maltese: L-anġjoedema tista' wkoll tidher bħala wieħed mis-sintomi ta' reazzjoni ta' sensittività eċċessiva sistemika akuta.
English: Randomised study arm
Maltese: Planġer abjad
English: All 16 patients who experienced acute systemic hypersensitivity reactions tested negative for pegvaliase-specific IgE at or near the time of the acute systemic hypersensitivity reactions episode.
Maltese: Is-16-il pazjent kollha li kellhom reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti kellhom test b'riżultat negattiv għal IgE speċifika għal pegvaliase fiż-żmien jew viċin iż-żmien tal-episodju tar-reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti.
English: • The goal is to reach a daily dose that lowers your blood phenylalanine levels to within the target range of 120 to 600 micromol/l and does not cause too many side effects.
Maltese: • L-għan huwa li tilħaq doża ta' kuljum li tbaxxi l-livelli tiegħek ta' phenylalanine fid-demm għall-medda fil-mira ta' 120 sa 600 micromol/L u ma tikkawżax ħafna effetti sekondarji.
English: Pegvaliase is a PEGylated recombinant phenylalanine ammonia lyase (rAvPAL), derived from the cyanobacterium Anabaena variablis expressed in Escherichia coli.
Maltese: IgM kontra phenylalanine ammonia lyase (PAL, phenylalanine ammonia lyase) kienet identifikata fil-pazjenti kollha bil-maġġoranza tal-pazjenti ttrattati (98%) li saru pożittivi f'xahrejn.
English: • train the observer to recognise signs and symptoms of an acute systemic hypersensitivity reaction and to seek immediate medical care if a reaction occurs, and how to properly administer adrenaline injection device (auto-injector or pre-filled syringe/pen).
Maltese: • iħarreġ lill-osservatur biex jagħraf is-sinjali u s-sintomi ta' reazzjoni ta' sensittività eċċessiva sistemika akuta u biex ifittex kura medika immedjata jekk isseħħ reazzjoni, u dwar il-mod xieraq kif għandu jintuża apparat għall-injezzjoni tal-adrenalina (awto-injettur jew siringa/pinna mimlija għal-lest).