FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Abseamed, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Maltese: Is-sustanza attiva f'Abseamed, l-epoetina alfa, hija kopja ta' ormon imsejjaħ eritropojetina, u taħdem eżattament bl-istess mod bħall-ormon naturali biex tistimula l-produzzjoni taċ-ċelloli ħomor tad-demm fil-mudullun.
English: • to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
Maltese: • għall-kura tal-anemija f'adulti b'sindromi majelodisplastiċi (kundizzjonijiet li fihom il-produzzjoni ta' ċelloli tad-demm b'saħħithom tkun difettuża).
English: Abseamed is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Maltese: Abseamed jintuża meta l-pazjenti jkunu f'riskju baxx jew intermedju li jiżviluppaw lewkimja majelojde akuta u jkollhom livelli baxxi tal-ormon naturali eritropojetina.
English: Another study showed that Abseamed injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Maltese: Studju ieħor fuq 114-il pazjent bil-kanċer li kienu qed jirċievu kimoterapija wera li Abseamed injettat taħt il-ġilda kien effettiv daqs Eprex/Erypo biex iżomm il-livelli ta' emoglobina f'livelli rakkomandati.
English: • patients undergoing surgery who cannot receive medicines for the prevention of blood clots;
Maltese: • pazjenti għaddejjin minn intervent kirurġiku li ma jistgħux jingħataw mediċini għall-prevenzjoni ta'
English: Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Abseamed outweighs the identified risk and it can be authorised.
Maltese: Għaldaqstant, il-fehma talAġenzija kienet li, bħal fil-każ ta' Eprex/Erypo, il-benefiċċju ta' Abseamed huwa akbar mir-riskju identifikat u li jista' jiġi awtorizzat.
English: Studies have also shown that giving Abseamed produces similar levels of the active substance in the body to giving Eprex/Erypo.
Maltese: L-istudji wrew ukoll li l-għoti ta' Abseamed jipproduċi livelli simili tas-sustanza attiva filġisem bħall-għoti ta' Eprex/Erypo.
English: • to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);
Maltese: • biex jiżdied l-ammont ta' demm li jista' jittieħed f'pazjenti adulti b'anemija moderata u b'livelli normali ta' ħadid fid-demm li ser ikollhom jagħmlu operazzjoni u jagħtu d-demm tagħhom stess qabel l-intervent kirurġiku (trasfużjoni tad-demm awtologa);
English: A/equine-2/Newmarket/2/93 strain
Maltese: A/equine-2/ South Africa/4/03 50 AU1 A/equine-2/ Newmarket/2/93
English: Vial (type I glass) closed with a halogenobutyl rubber stopper and aluminium cap
Maltese: Fjala (ħġieġ tip I) magħluqa b'tapp talgomma halogenobutyl u kappa tal-aluminjum
English: Tetanus toxoid
Maltese: Isem ivvintat Qawwa Għamla farmaċewtika
English: 1 dose 10 glass vials
Maltese: 10 fjali talħġieġ
English: 1 dose 1 pre-filled syringe
Maltese: --1 Strejn tal-virus tal-influwenza taż-żwiemel:
English: Ireland Pinewood Laboratories Limited, Ballmacarbry, Clonmel, Co.
Maltese: L-Irlanda Pinewood Laboratories Limited, Ballmacarbry, Clonmel, Co.
English: Tipperary,
Maltese: Tipperary, Ireland
English: List of the names, pharmaceutical form, strength of the medicinal product, route of administration, applicant / marketing authorisation holder in the Member States
Maltese: Lista tal-ismijiet, kompożizzjoni farmaċewtika, qawwa tal-prodott mediċinali, metodu ta' amministrazzjoni, applikant, detentur talawtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Maltese: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co.
English: Article 33(4) of Directive 2001/82/EC, as amended
Maltese: Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendat
English: International non-proprietary name (inn): doramectin
Maltese: Denominazzjoni internazzjonali komuni (inn): id-doramektin
English: The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia as concerned Member States, as well as Iceland and Norway.
Maltese: L-applikazzjoni ġiet ippreżentata lill-Irlanda bħala l-Istat Membru ta' Referenza u lill-Awstrija, il-Bulgarija, id-Danimarka, Spanja, il-Finlandja, Franza, l-Ungerija, il-Pajjiżi l-Baxxi, il-Polonja, ilPortugall, ir-Rumanija, l-Isvezja, is-Slovenja bħala Stati Membri kkonċernati, kif ukoll lill-Islanda u linNorveġja.
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Maltese: Iż-żewġ komposti jaqsmu spettru wiesa' ta' attività kontra l-parassiti u jipproduċu paraliżi simili fin-nematodi u lantropodi parassitiċi.
English: The applicant, Pfizer Limited, has submitted an application for a decentralised procedure for the above mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended.
Maltese: L-applikant, Pfizer Limited, ippreżenta applikazzjoni għal proċedura deċentralizzata għall-prodott mediċinali veterinarju msemmi hawn fuq fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, kif emendat.
English: Opinion following an Article 33(4)F F referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Maltese: Opinjoni wara referenza skont l-Artikolu 33(4)F F għas-soluzzjoni li titferra' Prontax 5 mg/ml għall-baqar u ismijiet assoċjati
English: Written explanations were provided by the applicant on 13 September 2011 and 11 January 2012.
Maltese: L-applikant ipprovda spjegazzjonijiet bil-miktub fit13 ta' Settembru 2011 u fil-11 ta' Jannar 2012.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France).
Maltese: Waqt il-proċedura deċentralizzata ġew identifikati riskji serji potenzjali rigward il-valutazzjoni tar-riskju ambjentali minn żewġ Stati Membri kkonċernati (il-Pajjiżi l-Baxxi u Franza).
English: Doramectin is a macrocyclic lactone and is closely related to ivermectin.
Maltese: IdDoramektin huwa lattone makroċikliku u huwa marbut ħafna mal-ivermektin.
English: Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli attwalment, is-CVMP qies li l-profil tal-benefiċċju u r-riskju tas-soluzzjoni li titferra' Prontax 5 mg/ml għall-baqar u ismijiet assoċjati huwa kkunsidrat pożittiv sakemm il-miżuri rrakkomandati ta' mitigazzjoni tar-riskju jiddaħħlu mal-informazzjoni dwar il-prodott rigward ir-riskju għall-organiżmi u l-fawna tad-demel.
English: Prontax 5 mg/ml pour-on solution for cattle (and associated names) contains doramectin.
Maltese: Is-soluzzjoni li titferra' Prontax 5 mg/ml għall-baqar (u ismijiet assoċjati) fiha d-doramektin.
English: EMA/282199/2012 EMEA/H/C/002448
Maltese: 26 ta' April 2012 EMA/382541/2012 EMEA/H/C/002448
English: This means that Pioglitazone Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Pioglitazone Teva Generics huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: On 26 January 2012, TEVA Generics B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone Teva Generics, for the treatment of type 2 diabetes.
Maltese: Fis-26 ta' Jannar 2012, TEVA Generics B.V. uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fissuq għal Pioglitazone Teva Generics, għat-trattament tad-dijabete tat-tip 2.
English: Pioglitazone Teva Generics was developed as a ‘generic medicine'.
Maltese: Pioglitazone Teva Generics ġie żviluppat bħala ‘mediċina ġenerika'.
English: What is Pioglitazone Teva Generics?
Maltese: X'inhu Pioglitazone Teva Generics?
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Generics had been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Pioglitazone Teva Generics għandu kwalità komparabbli u li huwa bijoekwivalenti għal Actos.
English: The active substance in Pioglitazone Teva Generics, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Pioglitazone Teva Generics, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u talfwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: Pioglitazone Teva Generics is a medicine that contains the active substance pioglitazone.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Because Pioglitazone Teva Generics is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone Teva Generics huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Actos.
English: How is Pioglitazone Teva Generics expected to work?
Maltese: Għalxiex kien mistenni li jintuża Pioglitazone Teva Generics?
English: The evaluation had finished and the CHMP had given a positive opinion.
Maltese: L-evalwazzjoni kienet waslet fi tmiemha u s-CHMP kien ta opinjoni pożittiva.
English: Pioglitazone Teva Generics was to used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Maltese: Pioglitazone Teva Generics kellu jintuża waħdu f'pazjenti li ma jkunux jistgħu jieħdu l-metformina (mediċina antidijabetika oħra).
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone Teva Generics for the treatment of type 2 diabetes.
Maltese: Dan jikkaġuna tnaqqis fil-livelli tal-glukożju fid-demm, u dan jgħin il-kontroll tad-dijabete tat-tip 2.
English: Osmolality: 260 - 290 mOsm/kg
Maltese: Osmolalità: 260 - 290 mOsm/kg
English: BioMarin Pharmaceutical Inc. Galli Drive Facility 46 Galli Drive
Maltese: Galli Drive Facility 46 Galli Drive
English: County Cork
Maltese: County Cork l-Irlanda
English: BioMarin International Limited Shanbally, Ringaskiddy County Cork
Maltese: BioMarin International Limited Shanbally, Ringaskiddy County Cork l-Irlanda
English: Linearity/nonlinearity
Maltese: Linearità/nuqqas ta' linearità
English: 0.5 ml
Maltese: INDIVIDWALI 0.5 mL
English: For more information, see section 5.1.
Maltese: Għal aktar informazzjoni, ara sezzjoni 5.1.
English: CA 94949
Maltese: CA 94949 l-Istati Uniti tal-Amerka
English: Abdominal pain2,4
Maltese: Uġigħ addominali2,4
English: Pegvaliase is rAvPAL conjugated with linear 20 kDa NHS-PEG at a degree of substitution of 28 to 44 moles of polymer/mole of protein.
Maltese: Pegvaliase huwa rAvPAL ikkonjugat bi 20 kDa NHS-PEG lineari fi grad ta' sostituzzjoni ta' 28 sa 44 moles ta' polymer/mole ta' proteina.
English: Osmolality: 285 - 315 mOsm/kg, viscous solution
Maltese: Soluzzjoni viskuża, 285 - 315 mOsm/kg
English: What Palynziq contains - The active substance is pegvaliase.
Maltese: X'fih Palynziq - Is-sustanza attiva hi pegvaliase.
English: Acute systemic hypersensitivity reactions were managed by administration of adrenaline (44%; 11/25 episodes), corticosteroids (56%; 14/25 episodes), antihistamines (56%; 14/25 episodes), and/or oxygen (8%; 2/25 episodes).
Maltese: Reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti kienu mmaniġġjati mill-għoti tal-adrenalina (44%; 11/25 episodju), kortikosterojdi (56%; 14/25 episodju), antistamini (56%; 14/25 episodju), u/jew ossiġnu (8%; 2/25 episodju).
English: The PEG molecule is expected to be primarily eliminated by renal filtration.
Maltese: Il-molekula PEG hija mistennija li tiġi eliminata primarjament permezz tal-filtrazzjoni renali.
English: In clinical studies, anti-PAL, anti-PEG and anti-pegvaliase have been identified as IgG and IgM mainly.
Maltese: Fi provi kliniċi, anti-PAL, anti-PEG u anti-pegvaliase ġew identifikati primarjament bħala IgG u IgM.
English: 12 weeks to 24 weeks2
Maltese: 12 sa 24 ġimgħa2
English: Table 1: Recommended dosing regimen
Maltese: Tabella 1: Skeda tad-dożaġġ rakkomandata
English: Figure F Inject at least 5 cm apart
Maltese: Figura F Injetta mill-inqas 5 cm 'il bogħod
English: EU/1/19/1362/001 1 x 2.5 mg pre-filled syringe EU/1/19/1362/002 1 x 10 mg pre-filled syringe EU/1/19/1362/003 1 x 20 mg pre-filled syringe EU/1/19/1362/004 10 x 20 mg pre-filled syringes
Maltese: EU/1/19/1362/001 siringa mimlija għal-lest ta' 1 x 2.5 mg EU/1/19/1362/002 siringa mimlija għal-lest ta' 1 x 10 mg EU/1/19/1362/003 siringa mimlija għal-lest ta' 1 x 20 mg EU/1/19/1362/004 siringi mimlija għal-lest ta' 10 x 20 mg
English: The most clinically significant hypersensitivity reactions include acute systemic hypersensitivity reaction (6%), angioedema (7%), and serum sickness (2%) (see sections 4.3 and 4.4).
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva l-aktar klinikament sinifikanti jinkludu reazzjoni ta' sensittività eċċessiva sistemika akuta (6%), anġjoedema (7%), u mard tas-serum (2%) (ara sezzjonijiet 4.3 u 4.4).
English: 6 Reflects high sensitivity CRP (hsCRP) levels above upper limit of normal (greater than 0.287 mg/dl) over a 6 month period.
Maltese: 6 Jirrifletti livelli ta' CRP ta' sensittività għolja (hsCRP, high sensitivity CRP) ogħla mill-ogħla limitu tan-normali (akbar minn 0.287 mg/dl) fuq perjodu ta' 6 xhur.
English: Adverse reaction(s) Induction/Titration1 Maintenance
Maltese: Induzzjoni/Titrazzjoni1 Manteniment
English: Musculoskeletal stiffness
Maltese: Ebusija muskolu-skeletrali
English: Hypersensitivity reaction2
Maltese: Reazzjoni ta' sensittività eċċessiva2
English: Study 302: Efficacy assessment
Maltese: Studju 302: Evalwazzjoni tal-effikaċja
English: Mean (SD) Median n=154
Maltese: Medjan n = 154
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Change from baseline protein intake (n)4
Maltese: Bidla mill-konsum ta' proteina fil-linja bażi (n)4
English: Mean (SD) change from baseline was 20 (323) micromol/l at Month 12 (n=9), -460 (685) micromol/l at Month 24 (n=5), and -783 (406) micromol/l at Month 36 (n=5).
Maltese: Il-bidla medja (SD) mil-linja bażi kienet 20 (323) micromol/L f'Xahar 12 (n = 9),460 (685) micromol/L f'Xahar 24 (n = 5), u -783 (406) micromol/L f'Xahar 36 (n = 5).
English: Excipients: trometamol, trometamol hydrochloride, sodium chloride, trans-cinnamic acid, water for injections.
Maltese: Eċċipjenti: trometamol, trometamol hydrochloride, sodium chloride, trans-cinnamic acid, ilma għall-injezzjonijiet.
English: The effects in offspring were associated with maternal toxicity.
Maltese: L-effetti fil-wild kienu assoċjati mat-tossiċità materna.
English: In clinical trials, 213 out of 285 (75%) patients experienced hypersensitivity reactions.
Maltese: Fil-provi kliniċi, 213 minn 285 (75%) pazjent kellhom reazzjonijiet ta' sensittività eċċessiva.
English: Persistent arthralgia (lasting at least 6 months) occurred in 19 (7%) patients with a total of 24 episodes.
Maltese: Seħħet artralġija persistenti (li damet mill-inqas 6 xhur) fi 19-il pazjent (7%) b'total ta' 24 episodju.
English: Colourless to pale yellow, clear to slightly opalescent solution with pH 6.6 - 7.4.
Maltese: Soluzzjoni bla kulur sa ftit safra, ċara sa ftit opalexxenti, b'pH ta' 6.6 - 7.4.
English: The median duration was 161 days (range: 35, 1408).
Maltese: It-tul ta' żmien medjan kien ta' 161 jum (medda: 35, 1,408).
English: In clinical trials, 21 out of 285 (7%) patients experienced 37 episodes of mild to moderate episodes of angioedema (symptoms include one or more of the following: pharyngeal oedema, swollen tongue, lip swelling, mouth swelling, eyelid oedema and face oedema) occurring independent of acute systemic hypersensitivity reactions.
Maltese: Fi provi kliniċi, 21 minn 285 (7%) pazjent kellhom 37 episodju ta' episodji ta' anġjoedema ħfief sa moderati (is-sintomi jinkludu wieħed jew aktar minn dawn li ġejjin: edema tal-farinġi, ilsien minfuħ, nefħa fix-xufftejn, nefħa fil-ħalq, edema ta' teqbet l-għajn u edema tal-wiċċ) li seħħew indipendentament minn reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti.
English: High sensitivity CRP levels increased6
Maltese: Żieda fil-livelli ta' CRP ta' sensittività għolja6
English: In clinical trials, 125 out of 285 (44%) patients developed a total of 237 episodes of hypophenylalaninaemia (blood phenylalanine levels below 30 micromol/l on two consecutive measurements).
Maltese: Fi provi kliniċi, 125 minn 285 (44%) pazjent żviluppaw total ta' 237 episodju ta' livelli baxxi ta' phenylalanine fid-demm (livelli ta' phenylalanine fid-demm aktar baxxi minn 30 micromol/L f'żewġ kejliet konsekuttivi).
English: Trometamol hydrochloride Sodium chloride trans-cinnamic acid Water for injections
Maltese: Sodium chloride trans-cinnamic acid
English: Persistent arthralgia occurred as early as 6 days and up to 1526 days into Palynziq treatment (median: 554 days from Palynziq treatment initiation).
Maltese: L-artralġija persisteni seħħet sa minn 6 ijiem u sa 1,526 jum tat-trattament b'Palynziq (medjan: 554 jum mill-bidu tat-trattament b'Palynziq).
English: Overall treatment experience from Study 301 and Study 302
Maltese: Esperjenza tat-trattament globali minn Studju 301 u Studju 302
English: • 1 alcohol pad
Maltese: • pad bl-alkoħol
English: Blood phenylalanine1
Maltese: Phenylalanine fid-demm1
English: Study 302 RDT Week 8
Maltese: Studju 302 Ġimgħa 8 tar-RDT
English: Palynziq 2.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Palynziq 2.5 mg
English: • is able to recognise the signs and symptoms of an acute systemic hypersensitivity reaction,
Maltese: • ikun kapaċi jagħraf is-sinjali u s-sintomi ta' reazzjoni ta' sensittività eċċessiva sistemika akuta,
English: The active substance is a covalent conjugate of the protein phenylalanine ammonia lyase (rAvPAL)* with NHS-methoxypolyethylene glycol (NHS-PEG).
Maltese: Is-sustanza attiva hija konjugat kovalenti tal-proteina phenylalanine ammonia lyase (rAvPAL)* ma' NHS-methoxypolyethylene glycol (NHS-PEG). * Anabaena variabilis rAvPAL magħmula minn teknoloġija tad-DNA rikombinanti f'Escherichia coli.
English: Four out of 16 (1%; 4/285) patients experienced a total of 5 episodes of acute systemic hypersensitivity reactions that were considered severe (see sections 4.3 and 4.8).
Maltese: Erbgħa minn 16-il pazjent (1%; 4/285) kellhom total ta' 5 episodji ta' reazzjonijiet ta' sensittività eċċessiva sistemiċi akuti li kienu kkunsidrati severi (ara sezzjonijiet 4.3 u 4.8).
English: Blue plunger
Maltese: Planġer blu
English: Adverse reactions were similar in type and frequency to that of adult patients.
Maltese: Ir-reazzjonijiet avversi kienu simili fit-tip u fil-frekwenza għal dawk ta' pazjenti adulti.
English: Twelve patients (11 patients from Study 301) aged 16 up to 18 years received Palynziq treatment.
Maltese: Tnax-il pazjent (11-il pazjent minn Studju 301) li kellhom 16-il sena sa 18-il sena rċivew trattament b'Palynziq.
English: At high pegvaliase Ctrough concentrations ≥ 10,000 ng/ml, the majority of the blood phenylalanine levels (97%) are ≤ 30 micromol/l, even when dietary phenylalanine intake is high.
Maltese: F'konċentrazzjonijiet Ctrough ta' pegvaliase għolja ta' ≥ 10,000 ng/mL, il-maġġoranza tal-livelli ta' phenylalanine fid-demm (97%) ikunu ≤ 30 micromol/L, anki meta l-konsum ta' phenylalanine fid-dieta jkun għoli.
English: Manifestations included a combination of the following acute signs and symptoms: syncope, hypotension, hypoxia, dyspnoea, wheezing, chest discomfort/chest tightness, tachycardia, angioedema (swelling of face, lips, eyes, and tongue), flushing, rash, urticaria, pruritus, and gastrointestinal symptoms (vomiting, nausea, and diarrhoea).
Maltese: Il-manifestazzjonijiet kienu jinkludu kombinazzjoni tas-sinjali u sintomi akuti li ġejjin: sinkope, pressjoni baxxa, ipossija, dispnea, tħarħir (man-nifs), skonfort fis-sider/għafis fis-sider, takikardija, anġjoedema (nefħa tal-wiċċ, xufftejn, għajnejn, u lsien), fwawar, raxx, urtikarja, ħakk, u sintomi gastrointestinali (rimettar, dardir, u dijarea).
English: A mean (SD) half-life at 20 mg and 40 mg were 47.3 hours (41.6 hours) and 60.2 hours (44.6 hours), respectively.
Maltese: 3 sigħat (41.6 sigħat) u 60.2 sigħat (44.6 sigħat), rispettivament.
English: In clinical trials, the majority of patients experienced injection site reactions (93%), arthralgia (85%), and hypersensitivity reactions (75%).
Maltese: Fi provi kliniċi, il-maġġoranza tal-pazjenti kellhom reazzjonijiet fis-sit tal-injezzjoni (93%), artralġija (85%), u reazzjonijiet ta' sensittività eċċessiva (75%).
English: Study 302 RDT baseline
Maltese: Studju 302 linja bażi tar-RDT
English: LS mean change from Study 302 RDT baseline to Week 8 (95% CI)
Maltese: Bidla medja LS minn linja bażi tar-RDT ta' Studju 302 għal Ġimgħa 8 (95% CI)
English: The most common cutaneous reactions (at least 5% of patients) reported were pruritus (37 patients; 13%), rash (33 patients; 12%), erythema (15 patients; 5%), and urticaria (15 patients; 5%).
Maltese: Ir-reazzjonijiet tal-ġilda l-aktar komuni (mill-inqas 5% tal-pazjenti) irrappurtati kienu ħakk (37 pazjent; 13%), raxx (33 pazjent; 12%), eritema (15-il pazjent; 5%), u urtikarja (15-il pazjent; 5%).
English: Mean blood phenylalanine levels reduced from 1233 micromol/l at baseline to 565 micromol/l at Month 12 (n=164) and 345 micromol/l at Month 24 (n=90), and these reductions in mean blood phenylalanine levels were maintained through Month 36 (341 micromol/l; n=48) (see Table 4 and Figure 1).
Maltese: Il-livelli medji ta' phenylalanine fid-demm naqsu minn 1,233 micromol/L fil-linja bażi għal 565 micromol/L f'Xahar 12 (n = 164) u 345 micromol/L f'Xahar 24 (n = 90), u dan it-tnaqqis fil-livelli medji ta' phenylalanine fid-demm ġie sostnut f'Xahar 36 (341 micromol/L;
English: In clinical trials, 16 out of 285 (6%) patients experienced 25 acute systemic hypersensitivity reactions of any severity.
Maltese: Fi provi kliniċi, 16 minn 285 (6%) pazjent kellhom 25 reazzjoni ta' sensittività eċċessiva sistemika akuta ta' kull tip ta' severità.
English: Mean (SD) Median n=172
Maltese: Medjan n = 172
English: Mean (SD) confusion score Change from baseline confusion score (n)4
Maltese: Punteġġ medju (SD) ta' konfużjoni Bidla mill-punteġġ ta' konfużjoni fil-linja bażi (n)4
English: Three out of 7 (1%) patients had severe serum sickness (see section 4.8).
Maltese: Tlieta minn 7 (1%) pazjenti kellhom mard tas-serum sever (ara sezzjoni 4.8).