FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Maltese: Il-pazjenti bis-sindromu ta' QT twila kkurati bi xylometazoline jistgħu jkunu f'riskju akbar ta' aritmiji ventrikolari serji.
English: Patients treated with immunosuppressants, including tacrolimus are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal).
Maltese: Pazjenti kkurati b'immunosuppressanti, inklużi tacrolimus huma f'riskju akbar għal infezzjonijiet inklużi infezzjonijiet opportunistiċi (batterjali, fungali, virali u protozoali) . Fost dawn il-kundizzjonijiet humabħal vajrus BK assoċjat man-nefropatija u l-vajrus JC assoċjat mal-lewkoenċefalopatija multifokali progressiva (PML).
English: Note: in the package leaflet the text ‘(e.g. long QT syndrome)' should be added to the bullet point mentioning heart disease, taking into account the already existing wording for nationally authorised medicinal products.
Maltese: Nota: fil-fuljett ta' tagħrif it-test “(eż. sindromu ta' QT twila)” għandu jiżdied mal-inċiż li jsemmi l-mard tal-qalb, filwaqt li jitqies il-kliem diġà eżistenti għal prodotti mediċinali awtorizzati b'mod nazzjonali.
English: if you suffer from a heart disease (e.g. long QT syndrome)
Maltese: jekk tbati minn mard tal-qalb (eż. sindromu ta' QT twila)
English: For package leaflets which do not mention ‘heart disease', a bullet point on ‘heart disease (e.g. long QT syndrome)' should be added, in line with the wording above.
Maltese: Għal fuljetti ta' tagħrif li ma jsemmux il-“mard tal-qalb”, għandu jiżdied inċiż dwar “mard tal-qalb” (eż. sindromu ta' QT twila)”, fil-linja mal-kliem ta' hawn fuq.
English: Janssen-Cilag GmbH, Johnson & Johnson Platz 1, 41470 Neuss, Germany
Maltese: Janssen-Cilag GmbH, Johnson & Johnson Platz 1, 41470
English: JANSSEN-CILAG FARMACEUTICA LDA., Estrada Consiglieri Pedroso No. 69 A/B, Queluz de Baixo, 2734-503 Barcarena, Portugal
Maltese: LDA., Estrada Consiglieri Pedroso No. 69 A/B, Queluz de Baixo, 2734-503 Barcarena, Portugal
English: Janssen-Cilag AB Staffans väg 2, SE-192 07 Sollentuna, SWEDEN
Maltese: Staffans väg 2, SE-192 07 Sollentuna, SWEDEN
English: 56, Eirinis Ave., GR15121 Pefki, Athens, Greece
Maltese: Janssen-Cilag Pharmaceutical S.A.C.I. 56, Eirinis Ave., GR15121 Pefki, Athens, Greece
English: Janssen-Cilag A/S Hammerbakken 19, DK3460 Birkerod, DENMARK
Maltese: Janssen-Cilag A/S Hammerbakken 19, DK3460
English: Janssen-Cilag SPA Janssen-Cilag SPA, Via M. Buonarroti, 23, 20093 Cologno Monzese (Milano), Italy
Maltese: Buonarroti, 23, 20093 Cologno Monzese (Milano), Italy
English: Janssen-Cilag Ltd 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, United Kingdom
Maltese: Way, High Wycombe, Buckinghamshire, HP12 4EG, United Kingdom
English: Janssen-Cilag NV Antwerpseweg 15-17, 2340 Beerse, Belgium
Maltese: Janssen-Cilag NV Antwerpseweg 15-17, 2340
English: Janssen-Cilag SA Antwerpseweg 15-17, 2340 Beerse, Belgium
Maltese: Janssen-Cilag SA Antwerpseweg 15-17, 2340
English: Janssen-Cilag Oy Vaisalantie 2, FI02130 Espoo, FINLAND
Maltese: Il-Finlandja Janssen-Cilag Oy Vaisalantie 2, FI
English: Czech Republic
Maltese: Republika Ċeka
English: Janssen-Cilag Pharmaceutical S.A.C.I.
Maltese: JANSSEN-CILAG FARMACEUTICA
English: Janssen-Cilag Ltd 50 - 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, United Kingdom
Maltese: Janssen-Cilag Ltd 50 - 100 Holmers Farm
English: Available data are described in sections 4.8 and 5.1.
Maltese: Fis-sezzjonijiet 4.8 u 5.1 hemm deskrizzjoni tad-data disponibbli.
English: Do not touch the dropper.
Maltese: (ara iktar 'l fuq).
English: Not known: flatulence, nausea, diarrhoea.
Maltese: Mhux magħruf: gass, nawżja, dijarrea.
English: A clinical trial including 298 patients with irritable bowel syndrome recruited in primary care centres showed a good or very good treatment success on Symbioflor E. coli in 62.9 % of the patients and in 39.4 % of the patients treated with placebo based on the investigator's global assessment of efficacy on a 4-point rating scale
Maltese: Prova klinika li kienet tinkludi 298 pazjent bis-sindromu tal-imsaren irritati reklutati f'ċentri tal-kura primarja, uriet suċċess tajjeb jew tajjeb ħafna tal-kura fuq Symbioflor E. coli f'62.9% tal-pazjenti u f'39.4% tal-pazjenti kkurati bi plaċebo, abbażi tal-valutazzjoni tal-effikaċja globali tal-investigatur fuq skala ta' punteġġi b'erba' punti.
English: Severe organic diseases of the gastrointestinal tract such as acute cholecystitis, acute pancreatitis, ileus, as well as cachexia and marasmus.
Maltese: Mard organiku gravi tal-passaġġ gastrointestinali bħal koleċistite akuta, pankreatite akuta, ileus kif ukoll kakessja u marażma.
English: An in-vitro study carried out using polymerase chain reaction (PCR) to investigate the effects of Symbioflor E. coli on epithelial cells (SW 480) from the human intestinal mucosa showed an upregulation of the cytokines IL-1β, TNF-α, GM-CSF and the chemokine IL-8.
Maltese: Coli fuq iċ-ċelluli tal-epitelju (SW 480) mill-mukoża intestinali umana wera regolazzjoni 'l fuq taċ-ċitokini IL-1β, TNF-α, GM-CSF u tal-kemokina IL-8.
English: In the group of children aged 12 - 18 years with the IBS subtype “pain + alternating diarrhoea and constipation” the physician's and patient/parent's assessment of efficacy was lowest (55 % or 66 %, respectively).
Maltese: Fi grupp ta' tfal ta' bejn it-12 u t-18-il sena bis-sottotip SII “uġigħ + daqqa dijarrea u daqqa stitikezza”, il-valutazzjoni tal-effikaċja magħmula mit-tabib u millpazjent/ġenitur kienet l-iżjed waħda baxxa (55% jew 66% rispettivament).
English: Package leaflet
Maltese: Pożoloġija
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare not known (cannot be estimated from the available data) The following undesirable effects may occur: Immune system disorders Common: urticaria
Maltese: Mhux komuni (≥1/1,000 sa <1/100) Rari (≥1/10,000 sa <1/1,000)
English: Antibiotics may inhibit the Escherichia coli bacteria and thus reduce the efficacy of this medicine.
Maltese: L-antibijotiċi jistgħu jinibixxu lill-batterji Escherichia coli u b'hekk inaqqsu l-effikaċja ta' din il-mediċina.
English: Duration of treatment
Maltese: Tqala u treddigħ
English: Pharmacotherapeutic group: Other immunostimulants, Antidiarrheal microorganisms ATC code: L03AX, A07FA
Maltese: L03AX, A07FA
English: Escherichia coli, the active substance in Symbioflor E. coli, is a living bacterium that is present in the healthy intestinal flora of humans.
Maltese: Escherichia coli, is-sustanza attiva f'Symbioflor E. coli, hija batterju ħaj preżenti fil-flora intestinali sana tal-bnedmin.
English: In an in-vitro gastric exposure model mimicking the human stomach and ileus under fasting conditions 1 ml (less than a single dose) of Symbioflor E. coli was tested for the survivability of the E. coli production strain.
Maltese: F'mudell in-vitro ta' esponiment gastriku li jimita l-istonku uman u l-ileus f'kundizzjonijiet ta' sawm, sar test b'1ml (inqas minn doża waħda) ta' Symbioflor E. coli dwar is-sopravivenza tar-razza ta' produzzjoni E. coli.
English: The qualitative effect on the gene expression in the mucosal epithelial cells, the key control elements of immune function in the human intestine, is similar to that exerted by the natural, physiological intestinal flora.
Maltese: L-effett kwalitattiv fuq l-espressjoni tal-ġeni fiċ-ċelluli tal-epitelju tal-mukoża, l-elementi ta' kontroll ewlenin tal-funzjoni immuni fl-intestini umani - huwa simili għal dak misjub fil-flora intestinali naturali u fiżjoloġika.
English: Prior to a diagnosis of 'irritable bowel syndrome', your doctor should exclude organic causes of the gastrointestinal disorders.
Maltese: Qabel ma ssir dijanjożi tas-"Sindromu tal-Imsaren Irritabbli", għandhom qabelxejn jiġu esklużi kawżi organiċi tad-disturbi gastrointestinali.
English: Duration of use of 8 weeks is recommended.
Maltese: Nirrakkomandaw 8 ġimgħat ta' kura.
English: Other medicines and Symbioflor E. coli
Maltese: Mediċini oħrajn u Symbioflor E. coli
English: The investigator's global assessment of tolerability was predominantly good to very good and balanced between Symbioflor E. coli and placebo.
Maltese: Il-valutazzjoni globali tal-investigatur tattollerabbiltà varjat kienet b'mod predominanti tajba għal tajba ħafna u bbilanċjata bejn Symbioflor E. coli u l-plaċebo.
English: This will cause slight turbidity.
Maltese: Dan jikkawża turbidità ħafifa.
English: The evaluation of undesirable effects is based on the following frequencies: Very common (≥1/10)
Maltese: Komuni (≥1/100 sa <1/10)
English: Overall, there is a shift in activity in favour of Th1 helper cells, accompanied by inhibition of the Th2 helper cells.
Maltese: B'mod ġenerali, hemm tendenza fl-attività favur ċelloli ajjutanti Th1, akkompanjati b'inibizzjoni taċ-ċelloli ajjutanti Th2.
English: E. coli.
Maltese: Il-batterji E.
English: Common: abdominal pain (including upper abdominal pain and abdominal discomfort).
Maltese: Komuni: uġigħ addominali (inklużi uġigħ fin-naħa ta' fuq tal-addome u skonfort addominali).
English: Do not take Symbioflor E. coli during acute illnesses with fever.
Maltese: Tiħux Symbioflor E. coli matul mard akut bid-deni.
English: Because of the high surface tension of Symbioflor E. coli, problems with starting and stopping release of the drops of solution cannot be completely avoided.
Maltese: Minħabba ttensjoni għolja fis-superfiċje ta' Symbioflor E. Coli, il-problemi bil-bidu u bil-waqfien tattqattir tas-soluzzjoni ma jistgħux jiġu evitati għalkollox.
English: The E. coli bacteria are excreted via the faeces.
Maltese: Coli jiġu ppurgati mal-feċi.
English: Overall, Symbioflor E. coli was well tolerated in the clinical trial with no significant differences in the tolerability compared to placebo regarding vital functions, body weight and all laboratory parameters tested.
Maltese: Coli kien ittollerat tajjeb fi prova klinika li ma rrappurtat l-ebda differenzi sinifikanti fit-tollerabbiltà meta mqabbla mal-plaċebo fir-rigward tal-funzjonijiet vitali, tal-piż tal-ġisem u tal-parametri tal-laboratorju kollha mistħarġa.
English: In a non-interventional study with 203 children aged 4 - 18 years, that were diagnosed for having IBS based on the ROM III criteria for children, the overall assessment of efficacy for all 4 IBS subtypes was very good to good in more than 80 % of the children for both, the physician's and the patient/parent's assessment.
Maltese: Fi studju mhux b'intervent fuq 203 tifel u tifla ta' bejn l-4 u t-18-il sena li kienet saritilhom dijanjożi ta' SII skont il-kriterji għat-tfal ROM III, il-valutazzjoni globali tal-effikaċja għall-4 sottotipi tas-SII kollha varjat minn tajba ħafna sa tajba f'iżjed minn 80% tat-tfal fiż-żewġ valutazzjonijiet, kemm f'dik tattabib kif ukoll f'dik tal-pazjent/ġenitur.
English: During acute febrile diseases, Symbioflor E. coli should be temporarily discontinued.
Maltese: Matul mard febrili akut, Symbioflor E.
English: Symbioflor E. coli should not be taken during a treatment with antibiotics or within 5 days after the end of such a treatment (see also section 4.5).
Maltese: Coli matul kuri bl-antibijotiċi jew fi żmien 5 ijiem wara t-tmiem ta' kura bħal din (ara wkoll sezzjoni 4.5).
English: The text below should be inserted by replacing the existing text of this section: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Section 3 How to take Symbioflor E. coli
Maltese: Jekk tinsa tieħu Symbioflor E. coli
English: When the same volume was tested in the SHIME model (Simulation of the Human Intestinal Microbial Ecosystem) under conditions simulating food intake fewer bacteria were killed in the stomach while their numbers were relatively stable in the conditions simulating the upper gastrointestinal tract.
Maltese: Meta sar test fuq l-istess volum bil-mudell SHIME (Simulazzjoni tal-Ekosistema Mikrobika tal-Imsaren Umani) f'kundizzjonijiet li jissimulaw il-konsum tal-ikel, inqatlu inqas batterji flistonku filwaqt li l-għadd tagħhom kien relattivament stabbli f'kundizzjonijiet li jissimulaw il-passaġġ gastrointestinali ta' fuq.
English: However, based on these limited data the safety profile for children and adolescents is considered to be comparable to that of adults.
Maltese: Madanakollu, abbażi ta' din id-data limitata, il-profil tas-sigurtà tat-tfal u l-adoloxxenti jitqies komparabbli ma' dak tal-adulti.
English: E. coli bacteria are not absorbed but act locally at the intestinal immune system.
Maltese: Il-batterji E. coli ma jiġux assorbiti iżda jaħdmu lokalment fis-sistema immunitarji tal-imsaren.
English: Symbioflor E. coli with food and drink Take the drops during meals (see section 3 How to take Symbioflor E. coli)
Maltese: Ħu l-qtar mal-ikel (ara s-sezzjoni 3 Kif għandek tieħu Symbioflor E. coli)
English: Not known (cannot be estimated from the available data): - Flatulence - Nausea - Diarrhoea
Maltese: Rari ħafna (<1/10,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: In a non-interventional study with 203 children aged 4-18 years no undesirable effects were reported.
Maltese: Fi studju mingħajr intervent li sar fuq 203 tifel u tifla ta' bejn l-4 u t-18-il sena ma ġie rrapportat l-ebda effett mhux mixtieq.
English: Efficacy was confirmed when using two post-hoc defined patient assessed endpoints, i.e. patient's assessment of symptoms and abdominal discomfort/pain comprising each of 8 or respectively 5 IBS relevant symptoms.
Maltese: L-effikaċja ġiet ikkonfermata bl-użu ta' żewġ punti ta' tmiem post-hoc ivvalutati mill-pazjenti stess, jiġifieri valutazzjoni mill-pazjent tas-sintomi u tal-uġigħ/skonfort addominali li inkludiet kull wieħed mit-8 sintomi relevanti għas-Sindrome tal-Imsaren Irritati (SII) jew inkella 5 minnhom rispettivament.
English: In a human whole-blood culture model, Symbioflor E. coli exerts strong modulating effects on the physiologically induced synthesis and release of cytokines and chemokines.
Maltese: Coli kellu effetti modulati qawwija fuq is-sinteżi indotti fiżjoloġikament u r-rilaxx taċ-ċitokini u tal-kemokini.
English: May 2020
Maltese: Mejju 2020
English: 370-0013 Gunma JAPAN
Maltese: 370-0013 Gunma
English: July 2019
Maltese: Lulju 2019
English: Gastrointestinal Disorders
Maltese: Disturbi gastrointestinali
English: 2132NP Hoofddorp The Netherlands
Maltese: 2132NP Hoofddorp
English: D-sorbitol E420
Maltese: L-histidine D-sorbitol E420
English: 2132NP Hoofddorp The Netherlands medinfo@kyowakirin.com
Maltese: 2132NP Hoofddorp L-Olanda medinfo@kyowakirin.com
English: Kyowa Kirin Co., Ltd. Takasaki Plant 100-1 Hagiwara-machi Takasaki
Maltese: Takasaki Plant 100-1 Hagiwara-machi Takasaki
English: RSS Total Score
Maltese: Punteġġ Totali RSS
English: There was no evidence of teratogenic effects.
Maltese: Ma kien hemm l-ebda evidenza ta' effetti teratoġeniċi.
English: Paediatric PK/PD
Maltese: PK/PD pedjatrika
English: This is a type of medicine called a human monoclonal antibody.
Maltese: Din hi tip ta' mediċina msejħa antikorp monoklonali uman.
English: The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: L-avvenimenti avversi huma ppreżentati skont is-sistema tal-klassifika tal-organi u l-kategoriji ta' frekwenza, definiti bl-użu talkonvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 sa <1/100); rari (≥1/10,000 sa <1/1000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Excipients: L-histidine, D- sorbitol E420, polysorbate 80, L-methionine, hydrochloric acid, 10%, and water for injections.
Maltese: L-histidine, D-sorbitol E420, polysorbate 80, L-methionine, hydrochloric acid, 10%, u ilma għall-injezzjonijiet.
English: Hyperphosphataemia
Maltese: Iperfosfatimija
English: Rickets Severity Score (RSS)
Maltese: Punteġġ tas-Severità tar-Rakitiżmu (RSS, Rickets Severity Score)
English: The most common adverse drug reaction (ADR) reported in paediatric patients up to 64 weeks was injection site reactions (57%), headache (54%), pain in extremity (42%), vitamin D decreased (28%), rash (23%), toothache (19%), tooth abscess (14%), myalgia (14%), and dizziness (11%) (See section 4.4 and ‘Description of selected adverse reactions' below).
Maltese: L-aktar reazzjoni avversa tal-mediċina (ADR, adverse drug reaction) irrappurtata f'pazjenti pedjatriċi għal sa 64 ġimgħa kienet reazzjonijiet fis-sit tal-injezzjoni (57%), uġigħ ta' ras (54%), uġigħ flestremitajiet (42%), tnaqqis fil-vitamina D (28%), raxx (23%), uġigħ fis-snien (19%), axxess fis-snien (14%), majalġja (14%), u sturdament (11%) (ara sezzjoni 4.4 u ‘Deskrizzjoni ta' reazzjonijiet avversi magħżula' hawn taħt).
English: CRYSVITA contains the active substance burosumab.
Maltese: CRYSVITA fih is-sustanza attiva burosumab.
English: Scores range from -3 (indicating severe worsening of rickets) to +3 (indicating complete healing of rickets).
Maltese: Il-punteġġi jvarjaw minn -3 (li jindika aggravament sever tar-rakitiżmu), sa +3 (li jindika fejqan komplet tar- rakitiżmu ).
English: Serum alkaline phosphatase activity
Maltese: Attività ta' alkaline phosphatase fis-serum
English: Genu varum inter-condylar distance and genu valgum inter-malleolar distance did not change from Baseline up to Week 64.
Maltese: Id-distanza genu varum inter-condylar u d-distanza genu valgum inter-malleolar ma nbidlux mil-Linja Bażi sa Ġimgħa 64.
English: Hydrochloric acid, 10% (for pH adjustment) Water for injections
Maltese: Hydrochloric acid, 10% (għal aggustament tal-pH) Ilma għall-injezzjonijiet
English: • Reactions where the injection was given, which may include:
Maltese: • Reazzjonijiet fejn tingħata l-injezzjoni, li jistgħu jinkludu:
English: Serum Phosphorus
Maltese: Phosphorus fis-Serum
English: Table 2: Rickets Response in Children 5-12 years Receiving Burosumab in Study UX023-CL201
Maltese: Tabella 2: Rispons tar-Rakitiżmu fi Tfal ta' 5-12-il sena Li Kienu Qed Jirċievu Burosumab fi Studju UX023-CL201
English: In paediatric patients, the most frequent potential hypersensitivity events were rash (22%), injection site rash (6%), and urticaria (4%).
Maltese: Avvenimenti potenzjali ta' sensittività eċċessiva l-aktar frekwenti fil-pazjenti pedjatriċi kienu raxx (22%), raxx fis-sit tal-injezzjoni (6%), u urtikarja (4%).
English: • Tooth abscess (infection)
Maltese: • Axxess fis-snien (infezzjoni)
English: • you are taking any phosphate or vitamin D supplements
Maltese: • phosphates jew supplimenti ta' vitamina D.
English: The maximum dose you will be given is 90 mg.
Maltese: Id-doża massima li se tingħatalek hi ta' 90 mg.
English: Adverse reactions reported in paediatric patients with XLH (N=65)
Maltese: Tabella 1: Reazzjoni avversa rrappurtati f'pazjenti pedjatriċi b'XLH (N=65)
English: Concurrent administration with oral phosphate, vitamin D analogues (see section 4.5).
Maltese: L-għoti fl-istess ħin ma' phosphate orali, analogi ta' vitamina D (ara sezzjoni 4.5).
English: Burosumab is a recombinant human monoclonal IgG1 antibody for FGF23 and is produced by recombinant DNA technology using Chinese hamster ovary (CHO) mammalian cell culture.
Maltese: Burosumab hu antikorp monoklonali uman rikombinanti IgG1 għal FGF23 u hu magħmul minn teknoloġija ta' DNA rikombinanti bl-użu ta' koltura taċ-ċelluli mammiferi tal-ovarji tal-ħamster Ċiniż (CHO, Chinese hamster ovary).
English: RGI-C Global Score LS Mean score (SE)
Maltese: RGI-C Punteġġ Medju tal-LS (SE)
English: The other ingredients are L-histidine, D-sorbitol (E420), polysorbate 80, L-methionine, 10%, hydrochloric acid, and water for injections.
Maltese: Is-sustanzi mhux attiva l-oħra huma L-histidine, D-sorbitol (E420), polysorbate 80, L-methionine, 10%, hydrochloric acid, u u ilma għall-injezzjonijiet.
English: Pack size of one vial.
Maltese: Pakkett ta' kunjett wieħed.
English: Twenty six of 52 patients received burosumab every two weeks (Q2W) at an average dose (min, max) of 0.73 (0.3, 1.5), 0.98 (0.4, 2.0) and 1.04 (0.4, 2.0) mg/kg at weeks 16, 40 and 60 respectively, and up to a maximum dose of 2.0 mg/kg.
Maltese: Sitta u għoxrin mit-52 pazjent irċivew burosumab kull ġimagħtejn (Q2W) f'doża medja (min, max) ta' 0.73 (0.3, 1.5), 0.98 (0.4, 2.0) u 1.04 (0.4, 2.0) mg/kg f'ġimgħat 16, 40 u 60 rispettivament, u sa doża massima ta' 2.0 mg/kg.
English: Burosumab is a recombinant human monoclonal antibody (IgG1) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23).
Maltese: Burosumab hu antikorp monoklonali uman rikombinanti (IgG1) li jeħel ma', u jinibixxi l-attività talfattur tat-tkabbir ta' fibroblast 23 (FGF23, fibroblast growth factor 23).
English: Ectopic mineralisation, as manifested by nephrocalcinosis, has been observed in patients with XLH treated with oral phosphorous and vitamin D analogues; these medicinal products should be stopped at least 1 week prior to initiating burosumab treatment (see section 4.2).
Maltese: Mineralizzazzjoni ektopika, kif manifestata minn nefrokalċinożi, ġiet osservata f'pazjenti b'XLH ittrattati b'phosphorous orali u analogi ta' vitamina D; dawn il-prodotti mediċinali għandhom jitwaqqfu mill-inqas ġimgħa qabel il-bidu tat-trattament bi burosumab (ara sezzjoni 4.2).
English: Table 1 gives the adverse reactions observed from clinical trials.
Maltese: Tabella 1 turi r-reazzjonijiet avversi osservati mill-provi kliniċi.
English: The AUC for the change from baseline in serum phosphate, TmP/GFR and 1,25(OH)2D increased linearly with increasing burosumab AUC.
Maltese: L-AUC għall-bidla mil-linja bażi talphosphate fis-serum, TmP/GFR u 1,25(OH)2D, żdiedu b'mod lineari maż-żieda fl-AUC ta' burosumab.
English: Bone-derived serum alkaline phosphatase content was 165 (52) μg/L [mean (SD)] at Baseline and 115 (31) μg/L at Week 64 (mean change: -28.5%).
Maltese: Il-kontenut ta' alkaline phosphatase fis-serum derivat mill-għadam kien ta' 165 (52) μg/L [medja (SD)] fil-Linja Bażi u 115 (31) μg/L f'Ġimgħa 64 (bidla medja: -28.5%).
English: No significant difference has been observed in paediatric patient pharmacokinetics or pharmacodynamics as compared with PK/PD in the adult population.
Maltese: Ma ġiet osservata l-ebda differenza sinifikanti fil-farmakokinetika jew fil-farmakodinamika ta' pazjenti pedjatriċi meta mqabbla mal-PK/PD fil-popolazzjoni adulta.
English: In Study UX023-CL205, mean (SD) fasting serum phosphate concentration increased from 0.81 (0.092) mmol/L at baseline to 1.12 (0.158) mmol/L at Week 40.
Maltese: Fi Studju UX023-CL205, il-medja (SD) tal-konċentrazzjoni tal-phosphate fis-serum żdiedet minn 0.81 (0.092) mmol/L fil-linja bażi. għal 1.12 (0.158) mmol/L f'Ġimgħa 40.
English: Burosumab is composed solely of amino acids and carbohydrates as a native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Maltese: Burosumab hu magħmul biss minn amino acids u karboidrati bħala immunoglobulina nattiva, u x'aktarx ma jiġix eliminat permezz ta' mekkaniżmi metaboliċi epatiċi.
English: The active substance is burosumab.
Maltese: Is-sustanza attiva hi burosumab.
English: The events were mild or moderate in severity.
Maltese: L-avvenimenti kienu ħfief jew moderati fisseverità.
English: In a murine model of XLH, a significant reduction in the incidence of ectopic mineralisation was observed at equivalent levels of serum phosphate, suggesting that the risk of mineralisation is less in the presence of excess FGF23.
Maltese: F'mudell murine ta' XLH, ġie osservat tnaqqis sinifikanti fl-inċidenza ta' mineralizzazzjoni ektopika f'livelli ekwivalenti tal-phosphate fisserum, li jissuġġerixxi li r-riskju tal-mineralizzazzjoni hu inqas fil-preżenza ta' FGF23 eċċessiv.
English: United Kingdom allphamed PHARBIL Arzneimittel GmbH Hildebrandstr.
Maltese: Ir-Renju Unit allphamed PHARBIL Arzneimittel GmbH Hildebrandstr. 10-12