FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline, 149 (57%) patients were receiving part of their total protein intake from medical food and 41 out of 261 (16%) patients were on a phenylalanine-restricted diet (defined as receiving greater than 75% of total protein intake from medical food).
Maltese: Fil-linja bażi, 149 (57%) pazjent kienu qed jirċievu parti mill-konsum totali tal-proteina minn ikel mediku u 41 minn 261 (16%) pazjent kienu fuq dieta ristretta tal-phenylalanine (definita bħala li wieħed jirċievi aktar minn 75% tal-konsum totali tal-proteina minn ikel mediku).
English: Figure 1: Mean (SE) phenylalanine levels over time
Maltese: Figura 1: Il-livelli medji (SE) ta' phenylalanine maż-żmien
English: Mean (SD) Median n=130
Maltese: Medjan n = 130
English: Blood phenylalanine concentration (micromol/l) Mean (SD)
Maltese: Konċentrazzjoni ta' phenylalanine fid-demm (micromol/L) Medja (SD)
English: Angioedema was managed with dose reduction (3 episodes; 8%), treatment interruption (5 episodes; 14%), treatment withdrawal (3 episodes; 8%), and/or concomitant medicinal products.
Maltese: L-anġjoedema kienet immaniġġjata permezz ta' tnaqqis fid-doża (3 episodji; 8%) interruzzjoni tat-trattament (5 episodji; 14%), waqfien mit-trattament (3 episodji; 8%), u/jew prodotti mediċinali konkomitanti.
English: Mean (SD) Median n=80
Maltese: Medjan n = 80
English: A total of 164 previously-treated Palynziq patients (152 patients from Study 301, and 12 patients from other Palynziq trials) continued treatment for up to 13 weeks.
Maltese: Total ta' 164 pazjent li qabel ġew ittrattati b'Palynziq (152 pazjent minn Studju 301, u 12-il pazjent minn provi oħra b'Palynziq) komplew it-trattament sa 13-il ġimgħa.
English: Of the 261 patients who enrolled in Study 301, 152 patients continued to the eligibility period of Study 302, and 51 patients continued directly from Study 301 into the long-term extension period of Study 302.
Maltese: Mill-261 pazjent li rreġistraw fi Studju 301, 152 pazjent komplew għall-perjodu ta' eliġibbiltà ta' Studju 302, u 51 pazjent komplew direttament minn Studju 301 fil-perjodu ta' estensjoni fit-tul ta' Studju 302.
English: All episodes resolved without sequelae (see Immunogenicity section).
Maltese: L-episodji kollha fiequ mingħajr konsegwenzi (ara s-sezzjoni Immunoġeniċità).
English: Pegvaliase is a PEGylated recombinant phenylalanine ammonia lyase enzyme that converts phenylalanine to ammonia and trans-cinnamic acid that are primarily eliminated by liver metabolism.
Maltese: Pegvaliase huwa enzima ta' phenylalanine ammonia lyase rikombinanti PEGilata li tikkonverti phenylalanine għal ammonja u trans-cinnamic acid li jiġu eliminati primarjament mill-metaboliżmu tal-fwied.
English: Do not use a microwave and do not place in hot water.
Maltese: Tużax microwave u tpoġġix f'ilma sħun.
English: The effects of Palynziq in the treatment of PKU have been demonstrated in patients with phenylketonuria in Study 301, an open-label study to initiate Palynziq treatment, and Study 302, a follow-on study for efficacy assessment.
Maltese: L-effetti ta' Palynziq fit-trattament ta' PKU ġew murija f'pazjenti b'fenilketonurija fi Studju 301, studju open-label biex jinbeda t-trattament b'Palynziq, u Studju 302, studju ta' segwitu għall-evalwazzjoni tal-effikaċja.
English: Treatment difference in LS mean change (95% CI)
Maltese: Differenza fit-trattament fil-bidla medja LS (95% CI) valur-P2
English: Mean (SD) blood phenylalanine (micromol/l)
Maltese: Il-livelli medji (SD) ta' phenylalanine fid-demm (micromol/L)
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes, ATC code: A16AB19
Maltese: Prodotti oħra tal-passaġġ tal-ikel u tal-metaboliżmu, Enzimi, Kodiċi ATC:
English: Injection site reactions were reported in 266 out of 285 (93%) patients.
Maltese: Ir-reazzjonijiet fis-sit tal-injezzjoni kienu rrappurtati f'266 minn 285 (93%) pazjent.
English: Angioedema occurred as early as 4 days and up to 1222 days into Palynziq treatment (median: 91 days from Palynziq treatment initiation).
Maltese: L-anġjoedema seħħet sa minn 4 ijiem u sa 1,222 jum tat-trattament b'Palynziq (medjan: 91 jum mill-bidu tat-trattament b'Palynziq).
English: Arthralgia episodes were managed with concomitant medicinal products (e.g., nonsteroidal anti-inflammatory drugs, glucocorticoids, and/or antipyretic), dose reduction (4% of episodes), treatment interruption (4% of episodes), or treatment withdrawal (0.6% of episodes), and 97% of arthralgia episodes resolved by the time of the data cut-off.
Maltese: L-episodji tal-artralġija kienu mmaniġġjati bi prodotti mediċinali konkomitanti (eż., mediċini kontra l-infjammazzjoni li mhumiex sterojdi, glukokortikojdi, u/jew antipiretiċi), tnaqqis fid-doża (4% tal-episodji), interruzzjoni tat-trattament (4% tal-episodji), jew waqfien mit-trattament (0.6% tal-episodji), u 97% tal-episodji tal-artralġija fiequ saż-żmien tal-għeluq tal-ġbir tad-dejta.
English: The immune response stabilises over 6 to 9 months of total treatment.
Maltese: Ir-reazzjoni immuni tistabbilizza fuq perjodu ta' 6 sa 9 xhur ta' trattament totali.
English: Cough2
Maltese: Treddigħ
English: Palynziq contains the active substance pegvaliase, an enzyme that can break down a substance called phenylalanine in the body.
Maltese: Palynziq fih is-sustanza attiva pegvaliase, enzima li tista' tkisser sustanza msejħa phenylalanine fil-ġisem.
English: Inject Palynziq
Maltese: Injetta Palynziq
English: The ADHD-RS IV inattention subscale ranges from 0 to 27, higher scores indicate a greater degree of impairment, and a score below 9 indicates that the patient is asymptomatic (i.e. has a score that is in the normative range).
Maltese: Is-sottoskala tad-distrazzjoni tal-ADHD-RS IV tvarja minn 0 għal 27, punteġġi ogħla jindikaw grad akbar ta' indeboliment, u punteġġ taħt 9 jindika li l-pazjent huwa mingħajr sintomi (jiġifieri, għandu punteġġ li jinsab fil-medda normativa).
English: Table 3: LS Mean change from RDT baseline in blood phenylalanine concentration (micromol/l) at RDT Week 8 in patients with PKU (Study 302)
Maltese: Tabella 3: Bidla medja LS minn linja bażi tar-RDT fil-konċentrazzjoni ta' phenylalanine fid-demm (micromol/L) f'Ġimgħa 8 tar-RDT f'pazjenti b'PKU (Studju 302)
English: Palynziq 20 mg
Maltese: Palynziq 20 mg darba kuljum³
English: 40 mg/day):
Maltese: (20 mg/jum jew 40 mg/jum):
English: Three injection site reactions consistent with granulomatous skin lesions were reported (each reaction occurring in one patient): granulomatous dermatitis (occurred 15 months after Palynziq treatment and lasted 16 days), xanthogranuloma (occurred 12 months after Palynziq treatment and lasted 21 months), and necrobiosis lipoidica diabeticorum (occurred 9 months after Palynziq treatment and lasted 9 months).
Maltese: Kienu rrappurtati tliet reazzjonijiet fis-sit talinjezzjoni konsistenti ma' feriti fuq il-ġilda granulomatużi (kull reazzjoni seħħet f'pazjent wieħed): dermatite granulomatuża (seħħet 15-il xahar wara t-trattament b'Palynziq u damet 16-il jum), ksantogranuloma (seħħet 12-il xahar wara t-trattament b'Palynziq u damet 21 xahar), u necrobiosis lipoidica diabeticorum (seħħet 9 xhur wara t-trattament b'Palynziq u damet 9 xhur).
English: Pretreatment baseline1
Maltese: Qabel it-trattament linja bażi1
English: The mean duration of serum sickness was 5 days and ranged from 1 to 8 days.
Maltese: Id-dewmien medju tal-mard tas-serum kien 5 ijiem u varja minn jum sa 8 ijiem.
English: The mean (SD) time from first dose of pegvaliase to onset was 372 (384) days.
Maltese: Iż-żmien medju (SD) mill-ewwel doża ta' pegvaliase għall-bidu kien ta' 372 (384) jum.
English: In clinical trials, 16 out of 285 (6%) patients experienced 25 acute systemic hypersensitivity reactions of any severity based on acute onset of skin and/or mucosal tissue manifestations and at least either respiratory compromise or reduced blood pressure (or associated symptoms of end-organ dysfunction).
Maltese: Reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti Fi provi kliniċi, 16 minn 285 (6%) pazjent kellhom 25 reazzjoni ta' sensittività eċċessiva sistemika akuta ta' kull tip ta' severità bbażati fuq bidu akut ta' manifestazzjonijiet tal-ġilda u/jew tat-tessut mukuż u mill-inqas kompromess respiratorju jew tnaqqis fil-pressjoni tad-demm (jew sintomi assoċjati ta' disfunzjoni fl-organi tat-tarf).
English: During dose escalation from 20 mg/day to 40 mg/day and 40 mg/day to 60 mg/day, a greater dose proportional increase in exposure was observed.
Maltese: Matul iż-żieda fid-doża minn 20 mg/jum għal 40 mg/jum u 40 mg/jum għal 60 mg/jum, kienet oservata żieda akbar fl-esponiment proporzjonali għad-doża.
English: Pegvaliase is primarily cleared by immune-mediated mechanisms following repeat dosing.
Maltese: Pegvaliase jiġi eliminat primarjament minn mekkaniżmu medjat b'mod immuni wara dożaġġ ripetut.
English: Hypersensitivity reactions were managed with dose reduction (3% of episodes), treatment interruption (5% of episodes), treatment withdrawal (2% of episodes), and/or concomitant medicinal products.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva kienu mmaniġġjati bi tnaqqis fid-doża (3% tal-episodji), interruzzjoni tat-trattament (5% tal-episodji), waqfien mit-trattament (2% tal-episodji), u/jew prodotti mediċinali fl-istess ħin.
English: Of the 261 enrolled patients, 195 (75%) patients reached their randomised maintenance dose (103 patients in the 20 mg once daily arm, 92 patients in the 40 mg once daily arm).
Maltese: Mill-261 pazjent irreġistrat, 195 (75%) pazjent laħqu d-doża tal-manteniment magħżula b'mod każwali (103 pazjenti fil-parti tal-istudju ta' 20 mg darba kuljum, 92 pazjent fil-parti tal-istudju ta' 40 mg darba kuljum).
English: 3 The maintenance dose is individualised to achieve blood phenylalanine levels between 120 to 600 micromol/l.
Maltese: ³ Id-doża ta' manteniment tiġi individwalizzata biex jinkisbu livelli ta' phenylalanine fid-demm ta' bejn 120 sa 600 micromol/L.
English: 20 mg daily
Maltese: 20 mg kuljum
English: Symptoms of mood (confusion, fatigue, depression, tension-anxiety, vigour, and anger domains) were evaluated using the Profile of Mood States (POMS) tool that has been modified to be specific to PKU (PKU-POMS).
Maltese: Sintomi tal-burdata (oqsma tal-konfużjoni, għeja kbira, depressjoni, tensjoni-ansjetà, ħeġġa, u rabja) kienu evalwati permezz tal-għodda tal-Profil tal-Istati tal-Burdata (POMS, Profile of Mood States) li ġiet immodifikata biex tkun speċifika għall-PKU (PKU-POMS).
English: Pre-filled syringe 20 mg (blue plunger): Each 20 mg carton contains 1 or 10 pre-filled syringes.
Maltese: Siringa mimlija għal-lest ta' 20 mg (planġer blu): Kull kartuna ta' 20 mg fiha 1 jew 10 siringi mimlija għal-lest.
English: Four out of 16 (1%; 4/285) patients experienced a total of 5 episodes of acute systemic hypersensitivity reactions considered severe based on the presence of: cyanosis or oxygen saturation (SpO2) less than or equal to 92%, hypotension (systolic blood pressure below 90 mm Hg in adults) or syncope.
Maltese: Erbgħa minn 16-il pazjent (1%; 4/285) kellhom total ta' 5 episodji ta' reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti kkunsidrati severi abbażi tal-preżenza taċ-ċijanosi jew saturazzjoni tal-ossiġnu (SpO2) anqas minn jew ugwali għal 92%, pressjoni baxxa (pressjoni tad-demm sistolika aktar baxxa minn 90 mm Hg fl-adulti) jew sinkope.
English: See section 6.3 for additional information on storage outside the refrigerator (below 25°C).
Maltese: Ara sezzjoni 6.3 għal informazzjoni addizzjonali fuq il-ħażna barra mill-friġġ (taħt temperatura sa 25°C).
English: Study 302 was a follow-on study (from Study 301) and included: an open label eligibility period; a double-blind, placebo-controlled randomised discontinuation trial period (RDT), and a long-term open-label extension period.
Maltese: Studju 302 kien studju ta' segwitu (minn Studju 301) u kien jinkludi: perjodu ta' eliġibbiltà open label; perjodu ta' prova tat-twaqqif fejn il-pazjenti ntgħażlu b'mod każwali (RDT, randomised discontinuation trial), double-blind, u kkontrollata mill-plaċebo, u perjodu open-label ta' estensjoni fit-tul.
English: Currently available data on patients aged 16 up to 18 years are described in section 4.8 and 5.1.
Maltese: Data attwalment disponibbli dwar pazjenti li jkollhom minn 16-il sena sa 18-il sena hija deskritta f'sezzjoni 4.8 u 5.1.
English: 40 mg daily
Maltese: 40 mg kuljum
English: 60 mg daily (3 consecutive injections of 20 mg pre-filled syringe)4
Maltese: 60 mg kuljum (3 injezzjonijiet konsekuttivi ta' siringa mimlija għal-lest ta' 20 mg)4
English: Injection site reactions were most frequent during induction and titration phase (90% of patients; 3899 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (64% of patients; 1110 episodes over mean treatment duration of 28 months).
Maltese: Ir-reazzjonijiet fis-sit tal-injezzjoni kienu l-aktar frekwenti matul il-fażi tal-induzzjoni u t-titrazzjoni (90% tal-pazjenti; 3,899 episodju fuq tul ta' żmien tat-trattament medju ta' 12-il xahar) u naqsu fil-fażi tal-manteniment (64% tal-pazjenti; 1,110 episodji fuq tul ta' żmien tat-trattament medju ta' 28 xahar).
English: In patients with baseline ADHD inattention scores > 9 (suggesting symptoms of inattention at baseline), mean reduction in ADHD inattention score from baseline (suggesting improvement) was above the MCID estimated for adults with ADHD at Month 12 (n=80; a reduction of 7.8), Month 18 (n=78; a reduction of 8.9), Month 24 (n=76; a reduction of 9.6) and Month 36 (n=45; a reduction of 10.6).
Maltese: F'pazjenti b'punteġġi ta' distrazzjoni ADHD fil-linja bażi > 9 (li jissuġġerixxu sintomi ta' distrazzjoni fil-linja bażi), it-tnaqqis medju fil-punteġġ ta' distrazzjoni ADHD mil-linja bażi (li jissuġġerixxi titjib) kien ogħla mill-MCID stmata għall-adulti b'ADHD f'Xahar 12 (n = 80; tnaqqis ta' 7.8), Xahar 18 (n = 78; tnaqqis ta' 8.9), Xahar 24
English: • This medicine comes in pre-filled syringes with 3 different strengths (2.5 mg-white plunger, 10 mg-green plunger, or 20 mg-blue plunger).
Maltese: • Din il-mediċina tiġi f'siringi mimlija għal-lest bi 3 qawwiet differenti (planġer abjad ta' 2.5 mg, planġer aħdar ta' 10 mg, jew planġer blu ta' 20 mg).
English: Palynziq contains sodium
Maltese: Palynziq fih is-sodium
English: o Management of acute systemic hypersensitivity reactions and information on retreatment o Key messages that must be conveyed and elements that must be addressed prior to self-injection by the patient, in particular: o training of patients to recognise the signs and symptoms of acute systemic hypersensitivity reactions and the action to be taken if such a reaction occurs o prescription of adrenaline injection device and training on its use o premedication requirements o provision of appropriate instruction on self-administration of pegvaliase o assessment of competency in self-injection by patient o requirement for a trained observer for at least the first 6 months of treatment o training of the observer to recognise the signs and symptoms of acute systemic hypersensitivity reactions, to seek immediate medical care if a reaction occurs, and how to properly administer adrenaline injection device o provision of the guide for patients and trained observers and patient alert card o Information about the observational study to evaluate long term safety and the importance of contributing to such a study where applicable
Maltese: o Immaniġġjar ta' reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti u informazzjoni dwar it-trattament mill-ġdid o Messaġġi ewlenin li jridu jiġu mwassla u elementi li jridu jiġu indirizzati qabel l-awto-injezzjoni mill-pazjent, b'mod partikolari: o it-taħriġ ta' pazjenti biex jirrikonoxxu s-sinjali u s-sintomi ta' reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti u l-azzjoni li għandha tittieħed jekk isseħħ tali reazzjoni o l-għoti b'riċetta ta' apparat għall-injezzjoni tal-adrenalina u taħriġ fuq l-użu tiegħu o rekwiżiti għal medikazzjoni minn qabel o li tiġi pprovduta istruzzjoni xierqa dwar l-għoti mill-pazjent lilu nnifsu ta' pegvaliase o l-evalwazzjoni tal-kompetenza fl-awto-injezzjoni mill-pazjent o il-ħtieġa għal osservatur imħarreġ għal mill-inqas l-ewwel 6 xhur tat-trattament o it-taħriġ tal-osservatur biex jirrikonoxxi s-sinjali u s-sintomi ta' reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti, biex ifittex kura medika immedjata jekk isseħħ reazzjoni, u l-mod xieraq kif għandu jintuża apparat għallinjezzjoni tal-adrenalina o li tiġi pprovduta gwida għall-pazjenti u osservaturi mħarrġa u kard ta' allert tal-pazjent o Informazzjoni dwar l-istudju osservazzjonali biex tiġi evalwata s-sigurtà fit-tul u l-importanza li wieħed jikkontribwixxi għal studju bħal dan fejn applikabbli
English: Placebo 40 mg once daily4
Maltese: Plaċebo 40 mg darba kuljum4
English: Table 2: Adverse reactions in patients treated with Palynziq System organ class
Maltese: Tabella 2: Reazzjonijiet avversi f'pazjenti ttrattati b'Palynziq
English: PEGylated proteins have the potential to elicit an immune response.
Maltese: Proteini PEGilati għandhom il-potenzjali li jipprovokaw reazzjoni immuni.
English: Pegvaliase plasma exposure was primarily driven by immune response to pegvaliase.
Maltese: L-esponiment għal pegvaliase fil-plażma kien dovut primarjament għar-reazzjoni immuni għal pegvaliase.
English: Following a single subcutaneous dose (0.01, 0.03 or 0.1 mg/kg), pegvaliase is absorbed slowly with a median tmax of 3.5 to 4 days (individual range of 2.5 to 7 days).
Maltese: Wara doża waħda taħt il-ġilda (0.01, 0.03 jew 0.1 mg/kg), pegvaliase jiġi assorbit bil-mod b'tmax medjan ta' 3.5 sa 4 ijiem (medda individwali ta' 2.5 sa 7 ijiem).
English: In clinical trials, serum sickness was reported in 7 out of 285 (2%) patients.
Maltese: Fi provi kliniċi, il-mard tas-serum kien irrappurtat f'7 minn 285 (2%) pazjent.
English: Angioedema3
Maltese: ANNESS II
English: Serum sickness occurred as early as 10 days and up to 232 days into Palynziq treatment (median: 13 days from Palynziq treatment initiation).
Maltese: Il-mard tas-serum seħħ sa minn 10 ijiem u sa 232 jum tat-trattament b'Palynziq (medjan: 13-il jum mill-bidu tat-trattament b'Palynziq).
English: Palynziq 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Palynziq 10 mg
English: - decrease in complement factors C3 and C4 proteins (which are parts of your immune system) in blood test - allergic reaction - too low levels of phenylalanine in blood tests - headache - skin rash - stomach pain - feeling sick, also called nausea - vomiting - hives (raised itchy rash on the skin) - itchiness - thinning or loss of hair - cough - increase in c-reactive protein (CRP) in blood test (CRP is a protein that indicates that you have inflammation) - swollen glands in the neck, armpit or groin - skin redness - muscle pain
Maltese: Komuni ħafna: jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni - ħmura tal-ġilda, nefħa, tbenġil, sensittività, jew uġigħ fejn tkun injettajt Palynziq - uġigħ fil-gogi - tnaqqis fil-proteini C3 u C4 tal-fatturi tal-komplement (li huma parti mis-sistema immunitarja tiegħek) fit-test tad-demm - reazzjoni allerġika - livelli baxxi wisq ta' phenylalanine fit-testijiet tad-demm - uġigħ ta' ras - raxx tal-ġilda - uġigħ fl-istonku - tħossok imdardar, jissejjaħ ukoll dardir - rimettar - ħorriqija (raxx bil-ħakk imqabbeż fuq il-ġilda) - ħakk - jeħfief jew jaqa' x-xagħar - sogħla - żieda fil-proteina reattiva-c (CRP, c-reactive protein) fit-test tad-demm (CRP hija proteina li tindika li għandek l-infjammazzjoni) - nefħa fil-glandoli tal-għonq, taħt id-dirgħajn jew tal-groin - ħmura tal-ġilda - uġigħ fil-muskoli
English: Table 4: Efficacy results at Month 12, Month 18, Month 24 and Month 36 in Palynziq-treated patients Baseline Month 12 Month 18 Month 24 Month 36
Maltese: Tabella 4: Ir-riżultati tal-effikaċja f'Xahar 12, Xahar 18, Xahar 24 u Xahar 36 f'pazjenti ttrattati b'Palynziq
English: Median change from baseline was -634 micromol/l at Month 12, -965 micromol/l at Month 24, and -913 micromol/l at Month 36.
Maltese: Il-bidla medja mil-linja bażi kienet -634 micromol/L f'Xahar 12,965 micromol/L f'Xahar 24, u -913 micromol/L f'Xahar 36.
English: Mean change from baseline PKU-POMS confusion subscale (suggesting improvement) was above MCID (defined as a reduction of at least 1) at Month 12 (n=130; a reduction of 1.6), Month 18 (n=123; a reduction of 2), Month 24 (n=117; a reduction of 2.2) and Month 36 (n=51; a reduction of
Maltese: Il-bidla medja mis-sottoskala ta' konfużjoni ta' PKU-POMS fil-linja bażi (li tissuġġerixxi tijib) kienet ogħla minn l-MCID (definita bħala tnaqqis ta' mill-inqas 1) fix-Xahar 12 (n = 130; tnaqqis ta' 1.6), Xahar 18 (n = 123; tnaqqis ta' 2), Xahar 24
English: 1 ml pre-filled syringe made of Type I borosilicate glass, equipped with a stainless steel 26 gauge needle, needle safety device, polypropylene plunger rod, and chlorobutyl rubber syringe stopper with fluoropolymer coating.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Siringa mimlija għal-lest ta' 1 mL magħmula minn ħġieġ borosilicate tat-Tip 1, mgħammra b'labra tal-azzar inossidabbli b'gauge ta' 26, apparat tal-protezzjoni tal-labra, stikka tal-planġer tal-polypropylene, u tapp tas-siringa tal-lastku tal-chlorobutyl b'kisi tal-fluoropolymer.
English: Reduced implantations were observed in normal female rats after administration of Palynziq (see section 5.3).
Maltese: Kienu osservati impjantazzjonijiet imnaqqsa fi ġrieden nisa normali wara l-għoti ta' Palynziq (ara sezzjoni 5.3).
English: Dietary phenylalanine intake should remain consistent until a maintenance dose is established.
Maltese: Il-konsum fid-dieta ta' phenylalanine għandu jibqa' konsistenti sakemm tiġi stabbilita doża ta' manteniment.
English: • Palynziq pre-filled syringe(s) in sealed tray(s).
Maltese: • Siringa(i) mimlija għal-lest ta' Palynziq fi trej(s) issiġillat(i).
English: The maintenance dose is individualised to achieve patient's blood phenylalanine control (i.e., a phenylalanine level between 120 to 600 micromol/l) taking into account patient tolerability to Palynziq and dietary protein intake (see Table 1).
Maltese: Id-doża ta' manteniment tiġi individwalizzata biex jinkiseb kontroll tal-phenylalanine fid-demm tal-pazjent (jiġifieri, livell ta' phenylalanine bejn 120 sa 600 micromol/L) wara li tiġi kkunsidrata t-tollerabilità tal-pazjent għal Palynziq u l-konsum fid-dieta tal-proteina (ara Tabella 1).
English: Prior to launch of Palynziq in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Palynziq f'kull Stat Membru, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH, Marketing Authorization Holder) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Following cellular uptake, the metabolism of phenylalanine ammonia lyase (PAL) is expected to occur via catabolic pathways and be degraded into small peptides and amino acids; the PEG molecule is metabolically stable and expected to be separated from PAL protein and primarily eliminated by renal filtration.
Maltese: Wara l-assorbiment ċellulari, il-metaboliżmu ta' phenylalanine ammonia lyase (PAL) huwa mistenni li jseħħ mill-passaġġi kataboliċi u jista' jiġi ddiżintegrat f'peptides żgħar u amino acids; il-molekula PEG hija metabolikament stabbli u hija mistennija li tiġi sseparata mill-proteina PAL u eliminata primarjament mill-filtrazzjoni renali.