FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder is Eli Lilly Nederland BV.
Maltese: Id-deterntur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Eli Lilly Nederland BV.
English: Ariclaim is a medicine that contains the active substance duloxetine.
Maltese: Ariclaim huwa mediċina li fiha s-sustanza attiva duloxetine.
English: It must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Maltese: Ma għandux jintuża flimkien ma' inibituri tal-monoamino ossidażi (monoamine oxidase inhibitors, grupp ta' antidepressivi), fluvoxamine (antidepressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta' antibijotiċi).
English: The active substance in Ariclaim, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva fi Ariclaim, duloxetine, hija inibitur tal-assorbiment mill-ġdid tas-serotonina u tannoradrenalina (serotonin-noradrenaline re-uptake inhibitor).
English: This summary was last updated in 08-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 08-2009.
English: Ariclaim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Maltese: Ariclaim ġie eżaminat f'żewġ studji li damu 12-il ġimgħa fuq 809 adulti dijabetiċi li ħassew uġigħ kuljum għal talanqas sitt xhur.
English: Ariclaim was originally also authorised at strengths of 20 and 40 mg for the treatment of moderate to severe stress urinary incontinence (SUI) in women, but the company withdrew these strengths when the marketing authorisation was renewed in August 2009.
Maltese: Oriġinarjament, Ariclaim kien awtorizzat ukoll fid-dożaġġi ta' 20 u 40 mg għat-trattament talinkontinenza urinarja minn sforz (SUI - stress urinary incontinence) minn moderata għal gravi fin-nisa, imma l-kumpanija rtirat dawn id-dożaġġi meta l-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda f'Awwissu 2009.
English: The marketing authorisation was renewed on 11 August 2009.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fil-11 ta' Awwissu 2009.
English: It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg).
Maltese: Huwa disponibbli f'forma ta' kapsuli gastroreżistenti (bojod u blu: 30 mg; ħodor u blu: 60 mg). “Gastroreżistenti” tfisser li l-kontenut talkapsuli jgħaddi mill-istonku u jibqa' intatt sa meta jilħaq il-musrana.
English: Ariclaim duloxetine
Maltese: Ariclaim duloxetine Sommarju tal-EPAR għall-pubbliku
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Ariclaim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
Maltese: Fiż-żewġ studji, it-tnaqqis tal-uġigħ deher mill-ewwel ġimgħa ta' trattament sa perjodu massimu ta' 12-il ġimgħa u l-pazjenti ttrattati b'Ariclaim kellhom punteġġ ta' wġigħ bejn 1.17 u 1.45 punt anqas minn dawk il-pazjenti ttrattati bil-plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ariclaim on 11 August 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Ariclaim fil-11 ta' Awwissu 2004.
English: The recommended dose of Ariclaim is 60 mg once a day, but some patients may need a higher dose of 120 mg per day.
Maltese: Id-doża rakkomandata ta' Ariclain hija 60 mg darba kuljum, iżda xi pazjenti aktarx jeħtieġu doża aktar qawwija ta' 120 mg kuljum.
English: It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Dan jaħdem billi jipprevjeni linnewrotrasmettituri 5-idrossitriptamina (5-hydroxytrypamine, imsejħa wkoll serotonina) u nnoradrenalina milli jerġgħu jiġu assorbiti fiċ-ċelloli nervużi fil-moħħ u fis-sinsla tad-dahar.
English: Why has Ariclaim been approved?
Maltese: Għaliex ġie approvat Ariclaim?
English: What is Ariclaim?
Maltese: X'inhu Ariclaim?
English: Other information about Ariclaim:
Maltese: Aktar tagħrif dwar Ariclaim:
English: Ariclaim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Maltese: Ariclaim f'dożaġġi ta' 60 mg darba jew darbtejn kuljum irriżulta aktar effikaċi biex inaqqas l-uġigħ meta mqabbel mal-plaċebo.
English: Three different doses of Ariclaim were compared with placebo.
Maltese: Mal-plaċebo tqabblu tliet dożaġġi differenti ta' Ariclaim.
English: What is the risk associated with Ariclaim?
Maltese: Għal xiex jintuża Ariclaim?
English: How has Ariclaim been studied?
Maltese: Kif ġie studjat Ariclaim?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim's benefits are greater than its risks for the treatment of diabetic peripheral neuropathic pain in adults.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Ariclaim huma ogħla mir-riskji tiegħu fit-trattament tal-uġigħ newropatiku periferiku dijabetiku fladulti.
English: Treatment must not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Maltese: It-trattament ma għandux jinbeda f'pazjenti bi pressjoni tad-demm għolja mhux ikkontrollata, minħabba riskju ta' kriżi ipertensiva (meta l-pressjoni tad-demm titla' f'daqqa u tkun perikoluża).
English: The most common side effects with Ariclaim (seen in more than 1 patient 10) are headache, somnolence (sleepiness), dizziness, nausea and dry mouth.
Maltese: L-effetti sekondarji l-aktar komuni b'Ariclaim (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, ħedla tan-ngħas, sturdament, nawżea u ħalq xott.
English: For the full list of all side effects reported with Ariclaim, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Ariclaim, ara l-Fuljett ta' Tagħrif.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Maltese: Ariclaim jintuża għat-trattament tal-uġigħ ikkawżat minn newropatija dijabetika periferika (ħsara linnervituri tal-estremitajiet li tista' sseħħ f'pazjenti li jbatu bid-dijabete).
English: MA (EU) Number (Invented) Name
Maltese: Numru ta' l-EU Isem (ivvintat)
English: Medicinal product no longer authorised
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: Pharmaceutical Form Route of Administration
Maltese: 98 pilloli 56 pilloli 56 pilloli 56 pilloli
English: Lonza Biologics 101 International Drive Pease International Tradeport 03801 Portsmouth United States
Maltese: Lonza Biologics 101 International Drive Pease International Tradeport 03801 Portsmouth L-Istati Uniti
English: Histological analysis of biopsies used Osteomeasure software (Osteometrics, USA).
Maltese: Analiżi istoloġika tal-bijopsiji użat Osteomeasure software (Osteometrics, USA).
English: Irritability
Maltese: Irritabilità
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Maltese: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Franza
English: SN {number}
Maltese: PC {numru} SN {numru} NN {numru}
English: The active substance is asfotase alfa.
Maltese: Is-sustanza attiva hi asfotase alfa.
English: 5/11 subjects displayed apparent catch-up height-gain.
Maltese: 5/11-il pazjent urew żieda fit-tul catch-up apparenti.
English: Green (x2)
Maltese: Aħdar (x2)
English: The mean age at sign/symptom onset was 1.49 months.
Maltese: L-età medja fil-bidu ta' sinjali/sintomi kienet ta' 1.49 xhur.
English: EU/1/15/1015/001 EU/1/15/1015/002 EU/1/15/1015/005 EU/1/15/1015/006 EU/1/15/1015/007 EU/1/15/1015/008 EU/1/15/1015/009 EU/1/15/1015/010
Maltese: EU/1/15/1015/005 EU/1/15/1015/006 EU/1/15/1015/007 EU/1/15/1015/008 EU/1/15/1015/009 EU/1/15/1015/010
English: Traceability
Maltese: Traċċabilità
English: Study ENB-002-08/ENB-003-08
Maltese: Studju ENB-002-08/ENB-003-08
English: The absolute bioavailability and absorption rate following subcutaneous administration were estimated to be 0.602 (95% CI: 0.567, 0.638) or 60.2% and 0.572 (95%CI: 0.338, 0.967)/day or 57.2%, respectively.
Maltese: Il-bijodisponibilità assoluta u r-rata ta' assorbiment wara l-għoti taħt il-ġilda ġew stmati li huma 0.602 (CI ta' 95% : 0.567, 0.638) jew 60.2% u 0.572 (CI ta' 95% : 0.338, 0.967)/jum jew 57.2%, rispettivament.
English: Pink
Maltese: Roża
English: Adverse reactions with asfotase alfa are listed by system organ class and preferred term using MedDRA frequency convention very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 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: Ir-reazzjonijiet avversi b'asfotase alfa huma elenkati skont is-sistema tal-klassifika tal-organi u terminu ppreferut bl-użu tal-konvenzjoni talfrekwenza MedDRA 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Contusion (bruise)
Maltese: Kontużjoni (tbenġil)
English: Orange
Maltese: Oranġjo
English: INFORMATION IN BRAILLE STRENSIQ 100 mg/ml 80 mg/0.8 ml
Maltese: INFORMAZZJONI BIL-BRAILLE STRENSIQ 100 mg/ml 80 mg/0.8 ml
English: There is potential for immunogenicity.
Maltese: Hemm il-potenzjal għal immunoġeniċità.
English: Hypophosphatasia
Maltese: Ipofosfatasija
English: Strensiq 100 mg/ml solution for injection EU/1/15/1015/003
Maltese: Strensiq 100 mg/ml soluzzjoni għall-injezzjoni EU/1/15/1015/003
English: X-ray changes from baseline were then rated using the Radiographic Global Impression of Change rating scale as follows: -3=severe worsening, -2=moderate worsening, -1=minimal worsening, 0=no change, +1=minimal healing, +2=substantial healing, +3= near-complete or complete healing.
Maltese: Imbagħad, it-tibdil fl-x-rays mil-linja bażi ġie kklassifikat bl-użu taliskala ta' klassifikazzjoni Radiographic Global Impression of Change kif ġej: -3=aggravament sever, -2=aggravament moderat, -1=aggravament minimu, 0=ebda bidla, +1=fejqan minimu, +2=fejqan sostanzjali, +3=fejqan kważi sħiħ jew fejqan sħiħ.
English: For management of adverse reactions, see sections 4.4 and 4.8.
Maltese: Għall-immaniġġjar ta' reazzjonijiet avversi, ara sezzjonijiet 4.4 u 4.8.
English: Nomenclature, symbols and units followed recommendations of the American Society for Bone and Mineral Research.
Maltese: Innomenklatura, is-simboli u l-unitajiet segwew ir-rakkomandazzjonijiet tal-American Society for Bone and Mineral Research.
English: Step 1: Preparing the Strensiq dose 1.
Maltese: Pass 1: Kif tipprepara d-doża ta' Strensiq 1.
English: Study ENB-006-09/ENB-008-10
Maltese: Studju ENB-006-09/ENB-008-10
English: Dark blue
Maltese: Blu skur
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n­nutrizzjoni
English: Asfotase alfa is a soluble glycoprotein comprised of two identical polypeptide chains, each with a length of 726 amino acids made from (i) the catalytic domain of human tissue-nonspecific alkaline phosphatase, (ii) the human immunoglobulin G1 Fc domain and (iii) a deca-aspartate peptide domain.
Maltese: (i) id-dominju katalitiku ta' alkaline phosphatase mhux speċifiku għat-tessut uman, (ii) id-dominju G1 Fc ta' immunoglobulina umana u (iii) dominju decaaspartate peptide.
English: Study ENB-010-10
Maltese: Studju ENB-010-10
English: Some patients required oral vitamin D supplements during the study (see sections 4.4 and 4.8).
Maltese: Xi pazjenti kellhom bżonn supplimenti ta' vitamina D orali matul l-istudju (ara sezzjonijiet 4.4 u 4.8).
English: Trained radiologists evaluated pre- and post-baseline x-rays of wrists and knees of patients for the following signs: apparent physeal widening, metaphyseal flaring, irregularity of provisional zone of calcification, metaphyseal radiolucencies, metadiaphyseal sclerosis, osteopenia, ‘popcorn' calcification in metadiaphysis, demineralization of distal metaphysis, transverse subphyseal band of lucency and tongues of radiolucency.
Maltese: Radjoloġisti mħarrġa evalwaw x-rays ta' qabel u wara l-linja bażi tal-polz u l-irkopptejn tal-pazjenti għassinjali li ġejjin: twessigħ apparenti tal-physeal, metaphyseal flaring, irregolarità ta' żona provviżorja ta' kalċifikazzjoni, metaphyseal radiolucencies, sklerożi tal-metadiaphyseal, osteopenija, kalċifikazzjoni ‘popcorn' fil-metadiaphysis, demineralizzazzjoni ta' metaphysis distali, transverse subphyseal band ta' lucency u ilsna ta' radiolucency.
English: It contains the active substance asfotase alfa.
Maltese: Fiha s-sustanza attiva asfotase alfa.
English: Step 4: Injecting Strensiq
Maltese: Pass 4: Kif tinjetta Strensiq
English: Pharmacokinetic data from all asfotase alfa clinical trials were analysed using population pharmacokinetic methods.
Maltese: Data farmakokinetika mill-provi kliniċi ta' asfotase alfa ġew analizzati bl-użu ta' metodi farmakokinetiċi tal-popolazzjoni.
English: Always use a new syringe contained in a protective plastic.
Maltese: Dejjem uża siringa ġdida li tkun fi plastik protettiv.
English: In adult patients with pediatric-onset HPP, the pharmacokinetics of asfotase alfa at doses of 0.5, 2 and 3 mg/kg administered three times per week was consistent with those observed in pediatric patients with pediatric-onset HPP, and thus supported the approved dose of 6 mg/kg per week in treating adult patients with pediatric-onset HPP.
Maltese: F'pazjenti adulti b'bidu ta' HPP pedjatriku, il-farmakokinetika ta' asfotase alfa b'dożi ta' 0.5, 2 u 3 mg/kg li ngħataw tliet darbiet fil-ġimgħa kienet konsistenti ma' dawk osservati f'pazjenti pedjatriċi b'bidu ta' HPP pedjatriku, u b'hekk tappoġġja d-doża approvata ta' 6 mg/kg kull ġimgħa fil-kura ta' pazjenti adulti b'bidu ta' HPP pedjatriku.
English: SC
Maltese: C.
English: OTHER 80 mg/0.8 ml
Maltese: 80 mg/0.8 ml
English: The central and peripheral volumes of distribution estimates for a patient with body weight of 70 kg (and 95% CI) were 5.66 (2.76, 11.6) L and 44.8 (33.2, 60.5) L, respectively.
Maltese: Il-volumi ċentrali u periferali tal-istimi tad-distribuzzjoni għal pazjent b'piż tal-ġisem ta' 70 kg (u CI ta' 95% ) kienu ta' 5.66 (2.76, 11.6) L u 44.8 (33.2, 60.5) L, rispettivament.
English: Patients underwent biopsy of the trans-iliac bone crest either as part of a control group or before and after exposure to asfotase alfa: - Control group, standard of care (5 evaluable patients): mean (SD) mineralisation lag-time was 226 (248) days at baseline and 304 (211) days at week 24 - 0.3 mg/kg/day asfotase alfa group (4 evaluable patients): mean (SD) mineralisation lag-time was 1236 (1468) days at baseline and 328 (200) days at week 48 - 0.5 mg/kg/day asfotase alfa group (5 evaluable patients): mean (SD) mineralisation lag-time was 257 (146) days at baseline and 130 (142) days at week 48 After approximately 48 weeks all patients were adjusted to the recommended dose 1.0 mg/kg/day.
Maltese: - Grupp ta' kontroll, standard ta' kura (5 pazjenti li setgħu jiġu evalwati): medja (SD) tal-lag-time tal-mineralizzazzjoni kienet ta' 226 (248) jum fil-linja bażi u 304 (211) ijiem f'ġimgħa 24 - Grupp ta' doża ta' 0.3 mg/kg/jum ta' asfotase alfa (4 pazjenti li setgħu jiġu evalwati): medja (SD) tal-lag-time tal-mineralizzazzjoni kienet ta' 1236 (1468) jum fil-linja bażi u 328 (200) jum f'ġimgħa 48 - Grupp ta' doża ta' 0.5 mg/kg/jum ta' asfotase alfa (5 pazjenti li setgħu jiġu evalwati): medja (SD) tal-lag-time tal-mineralizzazzjoni kienet ta' 257 (146) jum fil-linja bażi u 130 (142) jum f'ġimgħa
English: Ectopic calcification
Maltese: Kalċifikazzjoni ektopika
English: Trans-iliac crest bone biopsies were obtained by standard procedure.
Maltese: Bijopsiji tal-għadam trans-iliac crest inkisbu permezz ta' proċedura standard.
English: Pack sizes of 1 or 12 vials.
Maltese: Daqsijiet tal-pakkett ta' 1 jew 12-il kunjett.
English: Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ in clinical trials (see section 4.8).
Maltese: Lipodistrofija lokalizzata, inkluż lipoatrofija u lipoipertrofija, ġew irrappurtati fis-siti tal-injezzjoni wara bosta xhur f'pazjenti kkurati bi STRENSIQ fi provi kliniċi (ara sezzjoni 4.8).
English: Craniosynostosis
Maltese: Kranjosinostożi
English: Study ENB-010-10 was a controlled open-label study in 69 patients, aged 1 day to 72 months, with perinatal/infantile-onset HPP.
Maltese: L-Istudju ENB-010-10 kien studju kkontrollat, open-label li sar fuq 69 pazjent, li kellhom bejn jum u 72 xahar b'bidu ta' HPP perinatali/fl-infanzja.
English: Alternative assays (i.e. not utilizing an ALP-conjugated reporter system) may be considered in patients treated with Strensiq.
Maltese: Assaġġi alternattivi (i.e. li ma jużawx sistema ta' reporter konjugat b'ALP) jistgħu jiġu kkunsidrati f'pazjenti ttrattati bi Strensiq.
English: Study ENB-009-10
Maltese: Studju ENB-009-10
English: Clear, colourless to slightly yellow, aqueous solution; pH 7.4.
Maltese: Soluzzjoni ċara, bla kulur sa ftit safra, akwea, pH 7.4.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection Strensiq 40 mg/ml injection asfotase alfa
Maltese: Strensiq 40 mg/ml injezzjoni Strensiq 40 mg/ml injezzjoni Strensiq 40 mg/ml injezzjoni Strensiq 40 mg/ml injezzjoni asfotase alfa
English: The absolute bioavailability after the first and third subcutaneous administration ranged from 45.8 to 98.4%, with median Tmax ranging between 24.2 to 48.1 hours.
Maltese: Il-bijodisponibilità assoluta wara l-ewwel u t-tielet għoti taħt il-ġilda varjat bejn 45.8 sa 98.4, bit-Tmax medjan li varja bejn 24.2 sa 48.1 sigħat.
English: Dose to be injected
Maltese: Infezzjonijiet u infestazzjonijiet
English: Talk to your doctor in case of problems with your vision.
Maltese: Kellem lit-tabib tiegħek f'każ ta' problemi fil-vista.
English: However, in pregnant rabbits administered intravenous doses of up to 50 mg/kg/day asfotase alfa, anti-drug antibodies were detected in up to 75% of animals which could affect the detection of reproductive toxicity.
Maltese: Madankollu, fi fniek tqal li ngħataw dożi ġol-vini ta' sa 50 mg/kg/jum ta' asfotase alfa, antikorpi kontra l-mediċina ġew osservati f'sa 75% tal-annimali, li jista' jaffettwa l-osservazzjoni ta' tossiċità riproduttiva.
English: Among those 97 patients, 55 (56.7%) also showed the presence of neutralizing antibodies at some time point post-baseline.
Maltese: Fost dawk is-97 pazjent, 55 (56.7%) urew ukoll il-preżenza ta' antikorpi newtralizzanti f'xi punt ta' żmien wara llinja bażi.
English: Myalgia
Maltese: Mijalġija
English: Hypophosphatasia is associated with multiple bone manifestations including rickets / osteomalacia, altered calcium and phosphate metabolism, impaired growth and mobility, respiratory compromise that may require ventilation, and vitamin B6-responsive seizures.
Maltese: L-ipofosfatasija hi assoċjata ma' manifestazzjonijiet multipli tal-għadam li jinkludu raċite (rickets)/osteomalaċija, metaboliżmu mibdul tal-calcium u phosphate, indeboliment fit-tkabbir u l-mobilità, kompromess respiratorju li jista' jkun jeħtieġ ventilazzjoni, u aċċessjonijiet li jirrispondu għal vitamina B6.
English: NN {number}
Maltese: TA' EĊĊIPJENTI
English: The extrinsic factors affecting asfotase alfa pharmacokinetic exposures were formulation specific activity and total sialic acid content.
Maltese: Il-fatturi estrinsiċi li affettwaw l-esponimenti farmakokinetiċi ta' asfotase alfa kienu attività speċifika għall-formulazzjoni u l-kontenut totali ta' sialic acid.
English: For handling of the medicinal product before administration, see section 6.6.
Maltese: Għall-immaniġġjar tal-prodott mediċinali qabeljingħata, ara sezzjoni 6.6.
English: After the 3 mg/kg for 1.08 hours intravenous infusion, the median time (Tmax) ranged between 1.25 to 1.50 hours, and the mean (SD) Cmax ranged between 42694 (8443) and 46890 (6635) U/L over the studied cohorts.
Maltese: Wara l-infużjoni ġol-vini ta' 3 mg/kg għal 1.08 sigħat, il-ħin medjan (Tmax) varja bejn 1.25 sa 1.50 sigħat, u l-medja (SD) tas-Cmax varjat bejn 42694 (8443) u 46890 (6635) U/L fil-koorti studjati.
English: The effects of asfotase alfa on x-ray appearance
Maltese: L-effetti ta' asfotase alfa fuq id-dehra tal-x-ray
English: Sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, water for injections.
Maltese: Sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, ilma għall-injezzjonijiet.
English: 2 ml or 3 ml vial (Type I glass) with a stopper (butyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett ta' 2 ml jew 3 ml (ħġieġ ta' Tip I) b'tapp (lastku butyl) u siġill (aluminju) b'għatu flip-off (polypropylene).
English: Supportive safety data reflect exposure in 112 patients with perinatal/infantile (n=89), juvenile-onset (n = 22), adult onset (n = 1) HPP (age at enrollment from 1 day to 66.5 years) treated with asfotase alfa, with a treatment duration range from 1 day to 391.9 weeks [7.5 years]).
Maltese: Dejta dwar is-sigurtà ta' appoġġ tirrifletti l-esponiment f'112-il pazjent b'bidu ta' ipofosfatisija (HPPhypophosphatasia) perinatali/fl-infanzja (n=89), fiż-żgħożija (n=22), meta l-pazjent ikun adult (n=1) (età waqt ir-reġistrazzjoni minn jum sa 66.5 snin) ikkurati b'asfotase alfa, b'tul ta' żmien tal-kura li jvarja minn jum sa 391.
English: Hypersensitivity reactions include erythema/redness, pyrexia/fever, rash, pruritis, irritability, nausea, vomiting, pain, rigor/chills, hypaesthesia oral, headache, flushing, tachycardia, cough, and signs and symptoms consistent with anaphylaxis (see section 4.4).
Maltese: Reazzjonijiet ta' sensittività eċċessiva jinkludu eritema/ħmura, piressija/deni, raxx, prurite irritabbiltà, dardir, rimettar, uġigħ, rigor/tertir ta' bard, ipestesija orali, uġigħ ta' ras, fwawar, takikardija, sogħla, u sinjali u sintomi konsistenti ma' anafilassi (ara sezzjoni 4.4).
English: It is used for long-term enzyme replacement treatment to manage symptoms.
Maltese: Tintuża għal trattament fit-tul ta' sostituzzjoni tal-enzimi biex timmaniġġja s-sintomi.
English: Ophthalmic (conjunctival and corneal) calcification and nephrocalcinosis as manifestations of hypophosphatasia are documented in published literature.
Maltese: Kalċifikazzjoni oftalmika (tal-konġuntiva u tal-kornea) u nefrokalċinożi, bħala manifestazzjonijiet ta' ipofosfatasija huma ddokumentati fil-letteratura ppubblikata.
English: STRENSIQ 40 mg/ml 12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml
Maltese: STRENSIQ 40 mg/gml 12 mg/0.3 ml 18 mg/0.45 ml 28 mg/0.7 ml 40 mg/1 ml
English: Serum Parathyroid Hormone and Calcium
Maltese: Ormon Paratirojde u Calcium fis-Serum
English: Each vial contains 12 mg of asfotase alfa (12 mg/0.3 ml).
Maltese: Kull kunjett fih 12 mg ta' asfotase alfa (12 mg/0.3 ml).
English: Body Weight (kg)
Maltese: (kg)
English: What is Strensiq
Maltese: Tużax Strensiq
English: See section 5.1.
Maltese: Pass 5:
English: Ventilation support In studies ENB-002-08/ENB-003-08 (11 patients) and ENB-010-10 (69 patients), both open-label, nonrandomised, non-controlled studies of patients aged 0.1 to 312 weeks at baseline.
Maltese: Sapport b'ventilazzjoni Fl-istudji ENB-002-08/ENB-003-08 (11-il pazjent) u ENB-010-10 (69 pazjent), it-tnejn open-label, li fihom il-parteċipanti ma ntgħażlux b'mod każwali, mhux ikkontrollati, ta' pazjenti li kellhom minn 0.1 sa 312-il ġimgħa fil-linja bażi. 69 pazjent lestew l-istudji, u 11 waqfu.
English: Scar
Maltese: Dardir
English: 7/11 patients in the full analysis set achieved Radiographic Global Impression of Change scores of +2 at Week 24 compared to baseline radiographs.
Maltese: 7/11-il pazjent fis-sett sħiħ ta' analiżi kisbu punteġġi fir-Radiographic Global Impression of Changes ta' +2 f'Ġimgħa 24 meta mqabbla mal-x-rays fil-linja bażi.