FrancophonIA/ELRC3.0 huggingface dataset:
English: One of the two patients experienced a hypersensitivity reaction on day 15 after a single Palynziq dose within 15 minutes following medroxyprogesterone acetate, and subsequently experienced an acute systemic hypersensitivity reaction on day 89 within 30 minutes after the next dose of medroxyprogesterone acetate injectable suspension.
Maltese: Wieħed miż-żewġ pazjenti kellu reazzjoni ta' sensittività eċċessiva f'jum 15 wara doża waħda ta' Palynziq fi żmien 15-il minuta wara medroxyprogesterone acetate, u sussegwentament kellu reazzjoni ta' sensittività eċċessiva sistemika akuta f'jum 89 fi żmien 30 minuta wara d-doża li jmiss tas-sospensjoni ta' medroxyprogesterone acetate li tista' tiġi injettata.
English: The risk of arthralgia occurring is 2.9-fold higher in induction/titration phase compared to maintenance phase.
Maltese: Ir-riskju li sseħħ artralġija huwa 2.9 drabi ogħla fil-fażi ta' induzzjoni/titrazzjoni meta mqabbel mal-fażi tal-manteniment.
English: In cynomolgus monkeys, the incidence and severity of arterial inflammation was dose dependent and observed in a wide range of organs and tissues at clinically relevant exposures in the 4- and 39-week repeat-dose toxicology studies.
Maltese: Fix-xadini cynomolgus, l-inċidenza u s-severità ta' infjammazzjoni arterjali kienu dipendenti fuq id-doża u osservati f'firxa wiesgħa ta' organi u tessuti f'esponimenti klinikament rilevanti fl-istudji ta' effett tossiku minn dożi ripetuti tar-4- u d-39-ġimgħa.
English: Mean reduction (suggesting improvement) from baseline ADHD-RS inattention was above the minimally clinically important difference (MCID) for adults with ADHD (defined as a reduction of at least 5.2) at Month 18 (n=168; a reduction of 5.3), Month 24 (n=160; a reduction of 5.9) and Month 36 (n=92; a reduction of 6.7).
Maltese: It-tnaqqis medju (li jissuġġerixxi titjib) mid-distrazzjoni ta' ADHD-RS fil-linja bażi kien ogħla mid-differenza minimament klinikament importanti (MCID, minimally clinically important difference) għall-adulti b'ADHD (definita bħala tnaqqis ta' mill-inqas 5.2) f'Xahar 18 (n = 168; tnaqqis ta' 5.3), Xahar 24
English: Of the 9 angioedema episodes where time to onset was evaluable, 5 episodes occurred within 24 hours of injection, 4 episodes occurred between 24 hours and up to 29 days of injection.
Maltese: Mid-9 episodji ta' anġjoedema fejn iż-żmien għall-bidu tagħhom seta' jiġi evalwat, 5 episodji seħħew fi żmien 24 siegħa mill-injezzjoni, 4 episodji seħħew bejn 24 siegħa u sa 29 jum mill-injezzjoni.
English: The average molecular mass is approximately 1,000 kDa of which the protein moiety constitutes approximately 248 kDa.
Maltese: Il-medja tal-piż molekulari hi ta' madwar 1,000 kDa, li minnhom, il-moiety tal-proteina tikkostitwixxi madwar 248 kDa.
English: Of 253 patients who had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) at baseline in Study 301:
Maltese: Mill-253 pazjent li kellhom kontroll mhux adegwat tal-phenylalanine fid-demm (livelli ta' phenylalanine fid-demm ogħla minn 600 micromol/L) fil-linja bażi ta' Studju 301:
English: - The other ingredients are trometamol, trometamol hydrochloride, sodium chloride (see section 2 for further information), trans-cinnamic acid, water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma trometamol, trometamol hydrochloride, sodium chloride (ara sezzjoni 2 għal aktar informazzjoni), trans-cinnamic acid, ilma għall-injezzjonijiet.
English: Step 3: Allow Palynziq tray(s) to sit at room temperature for 30 minutes before opening: Let the sealed tray(s) sit at room temperature for at least 30 minutes.
Maltese: Pass 3: Ħalli t-trej(s) ta' Palynziq joqgħod(u) f'temperatura tal-kamra għal 30 minuta qabel ma tiftaħ:
English: (2 injections of 20 mg pre-filled syringe)1
Maltese: (2 injezzjonijiet ta' siringa mimlija għal-lest ta' 20 mg)1
English: Mean (SD) for apparent volume of distribution (Vz/F) at steady state following 20 mg and 40 mg doses was 26.4 L (64.8 L) and 22.2 L (19.7 L) respectively.
Maltese: L (64.8 L) u 22.2 L (19.7 L) rispettivament.
English: The impact of anti-PEG antibodies on the clinical effects of other PEG-containing medicinal products is unknown.
Maltese: L-impatt ta' antikorpi kontra l-PEG fuq l-effetti kliniċi ta' prodott mediċinali oħra li fihom PEG mhux magħruf.
English: Palynziq may also increase hypersensitivity to other PEGylated injectable medicinal products (see Effect of Palynziq on other PEGylated injectable medicinal products).
Maltese: Palynziq jista' wkoll iżid is-sensittività eċċessiva għal prodotti mediċinali li jistgħu jiġu injettati PEGilati (ara l-Effett ta' Palynziq fuq prodotti mediċinali li jistgħu jiġu injettati PEGilati oħra).
English: In Palynziq clinical trials, the majority of patients developed anti-PEG IgM and IgG antibodies after treatment with Palynziq (see section 4.8).
Maltese: IgG wara t-trattament b'Palynziq (ara sezzjoni 4.8).
English: Symptoms of inattention were assessed using the inattention subscale of the investigator-rated Attention Deficient Hyperactivity Disorder Rating Scale (ADHD-RS IV).
Maltese: Distrazzjoni ta' ADHD u konfużjoni ta' PKU-POMS maż-żmien Is-sintomi ta' distrazzjoni kienu evalwati permezz tas-sottoskala tad-distrazzjoni tal-Iskala ta' Klassifikazzjoni tad-Disturb ta' Nuqqas ta' Attenzjoni u Iperattività (ADHD-RS IV, Attention Deficient Hyperactivity Disorder Rating Scale IV) ikklassifikata mill-investigatur.
English: Reactions were managed by administration of adrenaline (10/16 patients; 11/25 episodes), corticosteroids, antihistamines, and/or oxygen under emergency medical care.
Maltese: Ir-reazzjonijiet kienu mmaniġġjati permezz tal-għoti tal-adrenalina (10/16-il pazjent; 11/25 episodju), kortikosterojdi, antistamini, u/jew ossiġnu taħt il-kura medika ta' emerġenza.
English: Each 2.5 mg pre-filled syringe contains 2.5 mg pegvaliase in 0.5 ml solution.
Maltese: Kull siringa mimlija għal-lest ta' 2.5 mg fiha 2.5 mg ta' pegvaliase f'soluzzjoni ta' 0.5 mL.
English: All patients treated with Palynziq developed a sustained total anti-pegvaliase antibody (TAb) response with a majority of patients (91%) becoming positive by Week 4.
Maltese: Il-pazjenti kollha ttrattati b'Palynziq żviluppaw rispons sostnut ta' antikorp kontra pegvaliase totali (TAb, total anti-pegvaliase antibody) bil-maġġoranza tal-pazjenti (91%) isiru pożittivi sa Ġimgħa 4.
English: Placebo 20 mg once daily4
Maltese: Plaċebo 20 mg darba kuljum4
English: • You will start Palynziq at the lowest dose.
Maltese: • Se tibda Palynziq fuq l-aktar doża baxxa.
English: 1 Blood phenylalanine level prior to initiating treatment with Palynziq.
Maltese: 1 Livell ta' phenylalanine fid-demm qabel il-bidu tat-trattament b'Palynziq.
English: 10 mg once a week 10 mg twice a week 10 mg four times a week 10 mg daily
Maltese: 10 mg darba fil-ġimgħa 10 mg darbtejn fil-ġimgħa 10 mg erba' darbiet fil-ġimgħa 10 mg kuljum
English: Other reactions reported included skin exfoliation, generalised rash, erythematous rash, maculo-papular rash, and pruritic rash.
Maltese: Reazzjonijiet oħra rrappurtati kienu jinkludu ġilda titqaxxar, raxx ġeneralizzat, raxx eritematuż, raxx makulopapulari, u raxx bil-ħakk.
English: The 261 enrolled patients were aged 16 to 55 years (mean: 29 years) and had a baseline mean blood phenylalanine of 1233 micromol/l.
Maltese: Il-261 pazjent irreġistrat kelhom bejn 16 u 55 sena (medja: 29 sena) u kellhom livell medju ta' phenylalanine fid-demm fil-linja bażi ta' 1,233 micromol/L.
English: Maintenance3
Maltese: Manteniment³
English: At lower plasma pegvaliase Ctrough concentrations < 10,000 ng/ml, patients with higher dietary phenylalanine intake tend to have higher blood phenylalanine levels compared to patients with the same Ctrough concentration and lower dietary phenylalanine intake, suggesting saturation of the enzyme (i.e. rAvPAL).
Maltese: F'konċentrazzjonijiet Ctrough ta' pegvaliase fil-plażma aktar baxxi ta' < 10,000 ng/mL, il-pazjenti b'konsum ogħla ta' phenylalanine fid-dieta għandhom tendenza li jkollhom livelli ta' phenylalanine fid-demm ogħla meta mqabbla ma' pazjenti bl-istess konċentrazzjoni Ctrough u konsum aktar baxx ta' phenylalanine fid-dieta, li jissuġġerixxi saturazzjoni tal-enzima (jiġifieri rAvPAL).
English: The strength indicates the quantity of the phenylalanine ammonia lyase (rAvPAL) moiety of pegvaliase without consideration of the PEGylation.
Maltese: Il-qawwa tindika il-kwantità tal-phenylalanine ammonia lyase (rAvPAL) moiety ta' pegvaliase mingħajr ma tiġi kkunsidrata il-PEGilazzjoni.
English: 10 mg daily
Maltese: TA' 10 MG
English: The bioavailability is not affected by the different injection sites on the body (see section 4.2).
Maltese: Il-bijodisponibilità mhix affettwata mis-siti ta' injezzjoni differenti fuq il-ġisem (ara sezzjoni 4.2).
English: Hypersensitivity reactions, including acute systemic hypersensitivity reactions, angioedema, and serum sickness, have been reported in patients treated with Palynziq and can occur at any time during treatment.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, inkluż reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti, anġjoedema, u mard tas-serum, ġew irrappurtati f'pazjenti ttrattati b'Palynziq u jistgħu jseħħu fi kwalunkwe ħin matul it-trattament.
English: 1 pre-filled syringe
Maltese: Kulur tas-siringa
English: At treatment initiation, 253 (97%) patients had inadequate blood phenylalanine control (blood phenylalanine levels above 600 micromol/l) and 8 patients had blood phenylalanine levels less than or equal to 600 micromol/l.
Maltese: Fil-bidu tat-trattament, 253 (97%) pazjent kellhom kontroll mhux adegwat tal-phenylalanine fid-demm (livelli ta' phenylalanine fid-demm ogħla minn 600 micromol/L) u 8 pazjenti kellhom livelli ta' phenylalanine fid-demm inqas minn jew ugwali għal 600 micromol/L.
English: Hypersensitivity reactions were most frequent during induction and titration phase (65% of patients; 921 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (58% of patients; 491 episodes over mean treatment duration of 28 months).
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva kienu l-aktar frekwenti matul il-fażi tal-induzzjoni u t-titrazzjoni (65% tal-pazjenti; 921 episodju fuq tul ta' żmien tat-trattament medju ta' 12-il xahar) u naqsu fil-fażi tal-manteniment (58% tal-pazjenti; 491 episodju fuq tul ta' żmien tat-trattament medju ta' 28 xahar).
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull siringa mimlija għal-lest, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The risk of an acute systemic hypersensitivity reaction occurring is 7-fold higher in induction/titration phase compared to maintenance phase.
Maltese: Ir-riskju li sseħħ reazzjoni ta' sensittività eċċessiva sistemika akuta hija 7 drabi ogħla fil-fażi ta' induzzjoni/titrazzjoni meta mqabbel mal-fażi tal-manteniment.
English: • Your doctor will prescribe medicines for you to take before your Palynziq injection, such as paracetamol, fexofenadine, and/or ranitidine.
Maltese: • It-tabib tiegħek se jagħmillek riċetta ta' mediċini biex teħodhom qabel l-injezzjoni ta' Palynziq, bħal paracetamol, fexofenadine, u/jew ranitidine.
English: o Swelling of the face, eyes, lips, mouth, throat, tongue, hands and/or feet o Trouble breathing or wheezing o Throat tightness or a choking feeling o Trouble swallowing or speaking o Feeling dizzy or fainting o Losing control of urine or stools o Rapid heartbeat o Hives (like an itchy, bumpy skin rash) that spreads quickly o Flushing o Severe stomach cramps or pain, vomiting, or diarrhoea
Maltese: o Nefħa fil-wiċċ, għajnejn, xufftejn, ħalq, griżmejn, lsien, idejn u/jew saqajn o Diffikultà biex tieħu n-nifs jew tħarħir (man-nifs) o Tagħfis fil-gerżuma jew sensazzjoni li qed tifga' o Diffikultà biex tibla' jew biex titkellem o Tħossok sturdat jew ikun ser iħossok ħażin o Titlef il-kontroll tal-awrina jew fl-ippurgar o Taħbit mgħaġġel tal-qalb o Ħorriqija (bħal raxx imqabbeż tal-ġilda bil-ħakk) li tinfirex malajr o Fwawar o Bugħawwieġ jew uġigħ sever fl-istonku, rimettar, jew dijarea
English: Additional findings in rabbits included increased abortions, foetal malformations and embryo/foetal lethality.
Maltese: Sejbiet addizzjonali fil-fniek kienu jinkludu żieda fl-aborti, malformazzjonijiet tal-fetu, u letalità tal-embrijun/fetu.
English: Protein intake from intact food (g) N
Maltese: Konsum ta' proteina minn ikel li mhux mediku (g) N
English: Complement factor C3 decreased5
Maltese: Tnaqqis fil-fattur tal-komplement C35
English: Necrobiosis lipoidica diabeticorum was treated with steroid injections and complicated by Pseudomonas infection.
Maltese: Necrobiosis lipoidica diabeticorum kienet ittrattata b'injezzjonijiet tal-isterojdi u kkumplikata b'infezzjoni Pseudomonas.
English: The most common injection site reactions (occurring in at least 10% of patients) were reaction, erythema, bruising, pruritus, pain, swelling, rash, induration, and urticaria.
Maltese: Ir-reazzjonijiet fis-sit talinjezzjoni l-aktar komuni (li seħħew f'mill-inqas 10% tal-pazjenti) kienu reazzjoni, eritema, tbenġil, ħakk, uġigħ, nefħa, raxx, ebusija, u urtikarja.
English: Patients continued Palynziq treatment in the long-term open-label extension period and dose was adjusted (5, 10, 20, 40 and 60 mg/day) by the physician to achieve further blood phenylalanine reductions and maintain previously achieved phenylalanine levels.
Maltese: Il-pazjenti komplew it-trattament b'Palynziq fil-perjodu open-label ta' estensjoni fit-tul u d-doża kienet aġġustata (5, 10, 20, 40 u 60 mg/jum) mit-tabib biex jintlaħaq aktar tnaqqis tal-phenylalanine fid-demm u jinżammu l-livelli ta' phenylalanine li nkisbu qabel.
English: The risk of injection site reactions occurring is 4.9-fold higher in induction/titration phase compared to maintenance phase.
Maltese: Ir-riskju li jseħħu reazzjonijiet fis-sit talinjezzjoni huwa 4.9 drabi ogħla fil-fażi ta' induzzjoni/titrazzjoni meta mqabbel mal-fażi tal-manteniment.
English: Relatively low titres of IgE has also been observed.
Maltese: Ġew osservati wkoll titres ta' IgE relattivament baxxi.
English: The most common hypersensitivity reactions (occurring in at least 10% of patients) were rash, urticaria, and hypersensitivity.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva l-aktar komuni (li jseħħu f'mill-inqas 10% tal-pazjenti) kienu raxx, urtikarja, u sensittività eċċessiva.
English: Arthralgia was most frequent during induction and titration phase (78% of patients; 1264 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (62% of patients; 612 episodes over mean treatment duration of 28 months).
Maltese: L-artralġija kienet l-aktar frekwenti matul il-fażi tal-induzzjoni u t-titrazzjoni (78% tal-pazjenti; 1,264 episodju fuq tul ta' żmien tat-trattament medju ta' 12-il xahar) u naqsu fil-fażi tal-manteniment (62% tal-pazjenti; 612 episodji fuq tul ta' żmien tat-trattament medju ta' 28 xahar).
English: Step 2: Remove Palynziq tray(s) from carton and check expiry date: - Take out the cartons needed for your dose from the refrigerator.
Maltese: Pass 2: Neħħi t-trej(s) ta' Palynziq mill-kartuna u ċċekkja d-data tal-iskadenza:
English: Uncontrolled blood phenylalanine levels (hyperphenylalaninaemia) before and during pregnancy are associated with increased risk for miscarriage, major birth defects (including microcephaly and major cardiac malformations), intrauterine foetal growth retardation and future intellectual disability with low IQ.
Maltese: Livelli ta' phenylalanine fid-demm mhux ikkontrollati (livelli għolja ta' phenylalanine fid-demm) qabel jew matul it-tqala huma assoċjati ma' riskju miżjud għal korriment, difetti tat-twelid maġġuri (li jinkludu mikroċefalija u malformazzjonijiet kardijaċi maġġuri), dewmien fl-iżvilupp tal-fetu ġol-utru u diżabilità intellettwali b'IQ baxx fil-futur).
English: Patients should be instructed to pre-medicate with an H1-receptor antagonist, H2-receptor antagonist, and antipyretic.
Maltese: Il-pazjenti għandhom jingħataw istruzzjonijiet biex jieħdu medikazzjoni minn qabel b'antagonista tar-riċettur H1, antagonista tar-riċettur H2, u antipiretiku.
English: Palynziq is a treatment for patients aged 16 years and older with phenylketonuria (PKU), a rare inherited disorder that causes phenylalanine from proteins in food to build up in the body.
Maltese: Palynziq huwa trattament għal pazjenti li jkollhom 16-il sena u aktar b'fenilketonurija (PKU), disturb rari li jintiret li jikkawża l-akkumulazzjoni fil-ġisem ta' phenylalanine mill-proteini fl-ikel.
English: The underlying mechanism for acute systemic hypersensitivity reactions observed in clinical trials was non-IgE mediated Type III (immune-complex mediated) hypersensitivity (see section 4.8).
Maltese: Il-mekkaniżmu sottostanti għal reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti li kien osservat fi provi kliniċi kien sensittività eċċessiva tat-Tip III mhux medjata minn IgE (medjata minn kumpless immunitarju) (ara sezzjoni 4.8).
English: 40 mg daily (2 consecutive injections of 20 mg pre-filled syringe)4
Maltese: 40 mg kuljum (żewġ injezzjonijiet konsekuttivi ta' siringa mimlija għal-lest ta' 20 mg)4
English: In clinical trials, doses of pegvaliase were explored up to 150 mg/day and no specific signs or symptoms were identified following these higher doses.
Maltese: Fil-provi kliniċi, ġew esplorati dożi ta' pegvaliase sa 150 mg/jum u ma ġew identifikati l-ebda sinjali u sintomi speċifiċi wara dawn id-dożi ogħla.
English: These reactions were consistent with a Type III immune-complex mediated hypersensitivity mechanism and were most frequent in the early phases of treatment (during the induction and titration periods) when the early immune response was dominated by PEG IgM, PEG IgG and PAL IgM responses and C3/C4 levels were at their lowest.
Maltese: Dawn ir-reazzjonijiet kienu konsistenti ma' mekkaniżmu ta' sensittività eċċessiva medjat minn kumpless immunitarju tat-Tip III u kienu l-aktar frekwenti fil-fażijiet bikrija tat-trattament (matul il-perjodi ta' induzzjoni u titrazzjoni) meta r-reazzjoni immuni tal-bidu kienet iddominata minn risponsi ta' PEG IgM, PEG IgG u PAL IgM u l-livelli C3/C4 kienu fl-aktar livell baxx li setgħu jkunu.
English: Cutaneous reactions lasting at least 14 days were most frequent during induction and titration phase (31% of patients; 137 episodes over mean treatment duration of 12 months) and decreased in maintenance phase (38% of patients; 129 episodes over mean treatment duration of 28 months).
Maltese: Ir-reazzjonijiet tal-ġilda li damu mill-inqas 14-il jum kienu l-aktar frekwenti matul il-fażi tal-induzzjoni u t-titrazzjoni (31% tal-pazjenti; 137 episodju fuq tul ta' żmien tat-trattament medju ta' 12-il xahar) u naqsu fil-fażi tal-manteniment (38% tal-pazjenti; 129 episodju fuq tul ta' żmien tat-trattament medju ta' 28 xahar).
English: Animal studies have shown maternal reproductive toxicity that was associated with decreased blood phenylalanine concentrations below normal levels (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva tal-omm li kienu assoċjati ma' tnaqqis fil-konċentrazzjonijiet ta' phenylalanine fid-demm taħt il-livelli normali (ara sezzjoni 5.3).
English: Severe systemic hypersensitivity reaction or recurrence of a mild to moderate acute systemic hypersensitivity reaction to pegvaliase, any of the excipients listed in section 6.1, or another PEGylated medicinal product (see section 4.4).
Maltese: Reazzjoni ta' sensittività eċċessiva sistemika severa jew terġa' titfaċċa reazzjoni ta' sensittività eċċessiva sistemika akuta minn ħafifa għal moderata għal pegvaliase, kwalunkwe mill-eċċipjenti mniżżla fis-sezzjoni 6.1, jew prodott mediċinali PEGilat ieħor (ara sezzjoni 4.4).
English: A PK/PD analysis using the Phase III data demonstrated an inverse pegvaliase exposure-phenylalanine response relationship, which could be influenced by dietary phenylalanine intake.
Maltese: III uriet relazzjoni inversa bejn l-esponiment għal pegvaliase u r-rispons ta' phenylalanine, li tista' tkun influwenzata mill-konsum ta' phenylalanine fid-dieta.
English: In rats, dose dependent vacuolation attributed to pegvaliase treatment was observed at clinically relevant exposures in the 4- and 26-week repeat-dose toxicity studies in rats in multiple organs and tissues, but not in cynomolgus monkeys.
Maltese: Fil-firien, il-vakwolazzjoni dipendenti fuq id-doża attribwita għat-trattament b'pegvaliase kienet osservata f'esponimenti klinikament rilevanti fl-istudji ta' effett tossiku minn dożi ripetuti tar-4- u s-26-ġimgħa fil-firien b'organi u tessuti multipli, iżda mhux fix-xadini cynomolgus.
English: 2.5 mg pre-filled syringe:
Maltese: 2.5 mg darba fil-ġimgħa
English: P-value2
Maltese: Sogħla2
English: Of the 164 patients that entered the eligibility period of Study 302, 86 patients met the eligibility criterion (achieved at least 20% mean blood phenylalanine reduction from pre-treatment baseline at their randomised dose within 13 weeks) and continued to the RDT, 12 patients discontinued treatment, and 57 patients did not enter the RDT and continued Palynziq treatment in the long-term extension period of Study 302, where they were allowed to increase dose.
Maltese: Mill-164 pazjent li daħlu fil-perjodu ta' eliġibbiltà ta' Studju 302, 86 pazjent issodisfaw il-kriterju ta' eliġibbiltà (laħqu mill-inqas tnaqqis medju ta' 20% ta' phenylalanine fid-demm mil-linja bażi ta' qabel it-trattament fid-doża tagħhom magħżula b'mod każwali fi żmien 13-il ġimgħa) u komplew għal RDT, 12-il pazjent waqqfu t-trattament, u 57 pazjent ma daħlux fl-RDT u komplew it-trattament b'Palynziq fil-perjodu ta' estensjoni fit-tul ta' Studju 302, fejn tħallew iżidu d-doża.
English: Of the 261 patients in Study 301, 11 patients were aged between 16 and 18 years at enrolment.
Maltese: Mill-261 pazjent fi Studju 301, 11-il pazjent kellhom bejn 16 u 18-il sena meta rreġistraw.
English: Date removed from refrigeration: _____/_____/______
Maltese: Data meta tneħħa mill-friġġ: _____/_____/______
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palynziq 2.5 mg injection pegvaliase
Maltese: U MNEJN GĦANDU JINGĦATA Injezzjoni ta' Palynziq 2.5 mg pegvaliase
English: Arthralgia3
Maltese: Xahar 36
English: Hypophenylalaninaemia occurred during titration and maintenance phase, as early as 51 days and up 1405 days into Palynziq treatment (median: 393 days from Palynziq treatment initiation).
Maltese: Il-livelli baxxi ta' phenylalanine fid-demm seħħew matul il-fażi tat-titrazzjoni u tal-manteniment, sa mill-51 jum u sa 1,405 ijiem tat-trattament b'Palynziq (medjan: 393 jum mill-bidu tat-trattament b'Palynziq).
English: Readministration following mild to moderate acute systemic hypersensitivity reactions: The prescribing physician should consider the risks and benefits of readministering the medicinal product following resolution of the first mild to moderate acute systemic hypersensitivity reaction (see sections 4.3 and 4.4).
Maltese: Għal reazzjonijiet ta' sensittività eċċessiva sistemiċi severi, jew jekk terġa' titfaċċa reazzjoni ta' sensittività eċċessiva sistemika akuta ħafifa għal moderata, il-pazjenti għandhom ifittxu kura medika immedjata u Palynziq għandu jiġi mwaqqaf b'mod permanenti (ara sezzjoni 4.3).
English: The risk of cutaneous reactions lasting at least 14 days occurring is 1.5-fold higher in induction/titration phase compared to maintenance phase.
Maltese: Ir-riskju ta' reazzjonijiet tal-ġilda li jdumu mill-inqas 14-il jum huwa 1.5 drabi ogħla fil-fażi ta' induzzjoni/titrazzjoni meta mqabbel mal-fażi tal-manteniment.
English: Check the expiry date on the carton.
Maltese: Iċċekkja d-data tal-iskadenza fuq il-kartuna.