FrancophonIA/ELRC3.0 huggingface dataset:
English: Adapalene Zentiva Adapalene 0.1% Cream
Maltese: Sanofi-Aventis Franza Adapalene Zentiva Adapalene 0.1%
English: Isotretinoin Sandoz Isotretinoin 20mg
Maltese: Isotretinoin Sandoz Ltd Isotretinoin 20mg Kapsula Kapsula, Ratba
English: Regiomedica Gmbh Regioderm Acitretin 10mg Capsule Capsule, Hard
Maltese: Ratiopharm Gmbh Isotretinoin Ratiopharm Isotretinoin 10mg Kapsula Kapsula, Ratba
English: Panretin
Maltese: Atralin
English: B.V.
Maltese: S.C.
English: Roche (Magyarország) Kft Roaccutan
Maltese: Roche (Magyarország)
English: Stiefel Laboratories Toctino
Maltese: Laboratoires Bailleul Sa Contracne
English: Genus
Maltese: Franza
English: Isotretinoin Actavis Isotretinoin 5mg Capsule Capsule, Soft
Maltese: Isotretinoin Puren Isotretinoin 10mg Kapsula Kapsula, Ratba
English: EMA/476469/2014 EMEA/H/C/000664
Maltese: EMEA/H/C/000664
English: It is available as capsules and sachets (250 and 500 mg).
Maltese: Jiġi bħala kapsuli u qratas (250 mg u 500 mg).
English: EPAR summary for the public stiripentol
Maltese: Sommarju tal-EPAR għall-pubbliku stiripentol
English: Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Maltese: Ġew osservati riżultati simili fit-tieni studju, b'67% li rreaġixxew għal Diacomit (8 minn 12) u 9% għall-plaċebo (1 minn 9).
English: The full EPAR for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Diacomit is an anti-epileptic medicine that contains the active substance stiripentol.
Maltese: Diacomit huwa mediċina antiepilettika li fiha s-sustanza attiva stiripentol.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Diacomit jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Diacomit.
English: The most common side effects with Diacomit (seen in more than 1 in 10 patients) are loss of appetite, weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders).
Maltese: L-effetti sekondarji l-iktar komuni b'Diacomit (li dehru f'iktar minn pazjent 1 minn kull 10) huma telf talaptit, tnaqqis fil-piż, insonnja (nuqqas ta' rqad), sturdament, atassija (inkapaċità li tikkoordina lmovimenti tal-muskoli), ipotonija (nuqqas ta' saħħa fil-muskoli) u distonija (disturbi fil-muskoli).
English: This was switched to a full marketing authorisation on 8 January 2014.
Maltese: Din l-awtorizzazzjoni għat-tqegħid fis-suq saret sħiħa fit-8 ta' Jannar 2014.
English: GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain.
Maltese: GABA huwa s-sustanza ewlenija fiċ-ċelloli tan-nervituri responsabbli mit-tnaqqis tal-attività elettrika tal-moħħ.
English: It has been shown in experimental models to increase the levels of a ‘neurotransmitter' called gamma aminobutyric acid (GABA) in the brain.
Maltese: F'mudelli sperimentali ntwera kif jiżdiedu l-livelli ta' ‘newrotrażmettitur' imsejjaħ aċidu gamma-aminobutirriku (GABA) fil-moħħ.
English: What is the risk associated with Diacomit?
Maltese: X'inhu r-riskju assoċjat ma' Diacomit?
English: Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.
Maltese: Diacomit jintuża flimkien ma' clobazam u valproate (mediċini antiepilettiċi oħra) bħala terapija miżjuda għall-kura ta' aċċessjonijiet toniċi-kloniċi ġeneralizzati (attakki severi, inklużi t-telf ta' kuxjenza) li l-aċċessjonijiet tagħhom mhumiex ikkontrollati biżżejjed bi clobazam u valproate.
English: Because the number of patients with SMEI is low, the disease is considered ‘rare', and Diacomit was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Maltese: Billi l-għadd ta' pazjenti b'SMEI huwa wieħed baxx, il-marda hija kkunsidrata ‘rari', u fil-5 ta' Diċembru 2001 Diacomit kien ikkwalifikat bħala ‘mediċina orfni' (mediċina għal mard rari).
English: In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20).
Maltese: Fl-ewwel studju, 71% tal-pazjenti li kienu qegħdin jieħdu Diacomit irreaġixxew għall-kura (15 minn 21), meta mqabbel ma' 5% tal-grupp tal-plaċebo (1 minn 20).
English: Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy' (SMEI), also known as Dravet's syndrome.
Maltese: Diacomit jintuża fit-tfal b'tip ta' epilessija rari ħafna msejħa ‘epilessija mijoklonika gravi fit-tfulija' (SMEI), magħrufa wkoll bħala sindromu ta' Dravet.
English: Why has Diacomit been approved?
Maltese: Għaliex ġie approvat Diacomit?
English: Diacomit has been studied in two main studies involving 65 children between three and 18 years of age.
Maltese: Iż-żewġ studji ewlenin ta' Diacomit kienu jinvolvu 65 tifel u tifla tal-età bejn tliet snin u 18-il sena.
English: Diacomit must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).
Maltese: Diacomit ma għandux jintuża f'pazjenti li kellhom psikożi (stat mentali serju b'disturb fis-sens tarrealità) b'attakki ta' delirju (stat mentali ta' konfużjoni, eċċitament, nuqqas ta' sabar u alluċinazzjonijiet).
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Diacomit on 4 January 2007.
Maltese: Tagħrif ieħor dwar DiacomitIl-Kummissjoni Ewropea tat awtorizzazzjoni kkondizzjonata għattqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Diacomit fl-4 ta' Jannar 2007.
English: The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected.
Maltese: Is-CHMP ikkonkluda li Diacomit wera l-effikaċja tiegħu fl-SMEI, għalkemm l-istudji kienu limitati u ma damux daqs kemm kien mistenni mill-Kumitat.
English: How has Diacomit been studied?
Maltese: Kif ġie studjat Diacomit?
English: What is Diacomit?
Maltese: X'inhu Diacomit?
English: The dose of valproate does not normally need to be adjusted.
Maltese: Normalment m'hemmx bżonn li d-doża ta' valproate tinbidel.
English: Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).
Maltese: Diacomit għandu jingħata mal-ikel iżda mhux ma' prodotti tal-ħalib, xorb bl-ilma karbonat, meraq talfrott, jew ikel jew xorb li fihom il-kaffeina jew it-teofillina (sustanza li tinsab fit-te iswed u aħdar, fost prodotti oħra).
English: The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully known.
Maltese: Mhuwiex magħruf sew il-mod eżatt kif stiripentol, is-sustanza attiva f'Diacomit, taġixxi bħala mediċina antiepilettika.
English: A patient was classified as a ‘responder' if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.
Maltese: Pazjent kien ikklassifikat bħala ‘risponder' jekk l-għadd ta' aċċessjonijiet fit-tieni xahar tal-kura kien mill-inqas 50% aktar baxx mill-għadd fix-xahar ta' qabel ma kienet inbdiet il-kura.
English: Other information about Diacomit
Maltese: Kif jintuża Diacomit?
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Maltese: Wara li jinbeda Diacomit, jista' jkun hemm il-ħtieġa li d-doża ta' clobazam titnaqqas.
English: See the package leaflet for the full list of restrictions.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet ara l-fuljett ta' tagħrif.
English: For the full list of all side effects reported with Diacomit, see the package leaflet.
Maltese: Iktar pazjenti rreaġixxew għall-kura b'Diacomit milli bil-plaċebo.
English: The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.
Maltese: Id-doża rakkomandata hija 50 mg għal kull kilo ta' piż korporali, maqsuma f'żewġ jew tliet dożi matul il-ġurnata.
English: This will usually take about two minutes.
Maltese: Dan normalment idum żewġ minuti.
English: Oestrogens, oral contraceptives
Maltese: Estroġeni, kontraċettivi orali
English: Anhydrous monosodium citrate Povidone K25
Maltese: Monosodium citrate, anidru Povidone K25
English: − clarithromycin, an antibiotic medicine used to treat infections
Maltese: − clarithromycin, mediċina antibijotika użata għat-trattament ta' infezzjonijiet
English: INFORMATION IN BRAILLE Jorveza 1mg
Maltese: INFORMAZZJONI BIL-BRAILLE Jorveza 1 mg
English: Depression, irritability, euphoria, psychomotor hyperactivity, anxiety, aggression
Maltese: Depressjoni, irritabilità, ewforija, iperattività psikomotorja, ansjetà, aggressjoni
English: − ketoconazole or itraconazole (to treat fungal infections)
Maltese: − ketoconazole jew itraconazole (għat-trattament ta' infezzjonijiet fungali)
English: Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Germany
Maltese: Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg
English: Systemic effects of glucocorticosteroids
Maltese: Effetti sistemiċi tal-glukokortikosterojdi
English: Take the carton and this leaflet with you if possible.
Maltese: Ħu l-kartuna u dan il-fuljett miegħek jekk dan ikun possibbli.
English: EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
Maltese: EU/1/17/1254/001 EU/1/17/1254/002 EU/1/17/1254/003 EU/1/17/1254/004
English: Jorveza contains sodium
Maltese: Jorveza fih sodium
English: CYP3A4 inhibitors
Maltese: Impedituri ta' CYP3A4
English: For information about the observed adverse reactions, see section 4.8.
Maltese: Għal informazzjoni dwar ir-reazzjonijiet avversi osservati, ara sezzjoni 4.8.
English: - The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol 6000, magnesium stearate, mannitol, anhydrous monosodium citrate, povidone K25, sodium hydrogen carbonate and sucralose (see also section 2, ”Jorveza contains sodium”).
Maltese: - Is-sustanzi mhux attivi l-oħra huma disodium hydrogen citrate, docusate sodium, macrogol 6000, magnesium stearate, mannitol, monosodium citrate anidru, povidone K25, sodium hydrogen carbonate u sucralose (ara wkoll sezzjoni 2, “Jorveza fih sodium”).
English: Tel: +385 1 4650358 wurth@zg.t-com.hr
Maltese: +385 1 4650358 wurth@zg.t-com.hr
English: Ewopharma, spol.
Maltese: Ewopharma, spol. s r. o.
English: EU/1/17/1254/001 (20 orodispersible tablets) EU/1/17/1254/002 (30 orodispersible tablets) EU/1/17/1254/003 (60 orodispersible tablets) EU/1/17/1254/004 (90 orodispersible tablets) EU/1/17/1254/005 (100 orodispersible tablets)
Maltese: EU/1/17/1254/001 (20 pillola li tinħall fil-ħalq) EU/1/17/1254/002 (30 pillola li tinħall fil-ħalq) EU/1/17/1254/003 (60 pillola li tinħall fil-ħalq) EU/1/17/1254/004
English: Glaucoma, cataract (including subcapsular cataract), blurred vision, central serous chorioretinopathy (CSCR) (see also section 4.4)
Maltese: Glawkoma, katarretti (inkluż katarretti subkapsulari), vista mċajpra, korjoretinopatija seruża ċentrali (CSCR, central serous chorioretinopathy) (ara wkoll sezzjoni 4.4)
English: Dyspepsia, duodenal or gastric ulcers, pancreatitis, constipation
Maltese: Dispepsja, ulċeri duwodenali jew gastriċi, pankreatite,
English: The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased.
Maltese: Ir-riskju ta' reazzjonijiet avversi (effetti ta' glukokortikosterojdi sistemiċi) se jiżdied.
English: − ritonavir and cobicistat (to treat HIV infections)
Maltese: − ritonavir u cobicistat (għat-trattament ta' infezzjonijiet tal-HIV)
English: − oestrogens (used for hormone replacement therapy or contraception)
Maltese: − estroġeni (użati għal terapija ta' sostituzzjoni tal-ormoni jew kontraċezzjoni)
English: A relevant proportion of budesonide is metabolised in the liver by CYP3A4.
Maltese: Proporzjon rilevanti ta' budesonide huwa metabolizzat fil-fwied permezz ta' CYP3A4.
English: Pseudotumor cerebri including papilloedema in adolescents
Maltese: Psewdotumur ċerebri inkluża papilloedima fl-adolexxenti
English: Following administration of Jorveza, budesonide is rapidly absorbed.
Maltese: Wara l-għoti ta' Jorveza, budesonide jiġi assorbit rapidament.
English: s r. o. Tel: +420 267 311 613 info@ewopharma.cz
Maltese: Tel: +420 267 311 613 info@ewopharma.cz
English: 20 orodispersible tablets 30 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Maltese: 20 pillola li tinħall fil-ħalq 30 pillola li tinħall fil-ħalq 60 pillola li tinħall fil-ħalq 90 pillola li tinħall fil-ħalq 100 pillola li tinħall fil-ħalq
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2.6% tal-konsum massimu ta' kuljum ta' sodium rakkomandat fid-dieta għal persuna adulta.
English: Frequencies are defined as 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) or not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi 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), jew mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: In particular:
Maltese: NN:
English: In the treatment of EoE with Jorveza, budesonide inhibits antigen-stimulated secretion of many pro-inflammatory signal molecules such as thymic stromal lymphopoeitin, interleukin-13 and eotaxin-3 in the esophageal epithelium, which results in a significant reduction of the esophageal eosinophilic inflammatory infiltrate.
Maltese: Fit-trattament ta' EoE b'Jorveza, budesonide jinibixxi t-tnixxija stimulata mill-antiġen ta' ħafna molekuli tas-sinjali pro-infjammatorji bħal thymic stromal lymphopoeitin, interleukin-13 u eotaxin-3 fl-epitelju esofagali, li jwassal għal tnaqqis sinifikanti tal-infiltrat esofagali eosinofiliku infjammatorju.
English: Plasma protein binding is on average 85-90%.
Maltese: L-irbit mal-proteini fil-plażma huwa bħala medja ta' 85-90%.
English: Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Maltese: Jorveza huwa indikat għall-kura tal-esofagite eżinofilika (EoE, eosinophilic esophagitis) fl-adulti (li għandhom iktar minn 18-il sena).
English: Jorveza comes in blisters in packs with 20, 30, 60, 90 or 100 orodispersible tablets.
Maltese: Jorveza huwa fornut f'folji f'pakketti b'20, 30, 60, 90 jew 100 pillola li jinħallu fil-ħalq.
English: Pack sizes: 20, 30, 60, 90 or 100 orodispersible tablets.
Maltese: Daqsijiet tal-pakkett: pakketti b'folji b'20, 30, 60, 90 jew 100 pillola li jinħallu fil-ħalq.
English: The mean peak plasma concentration (± standard deviation) was 0.44 ± 0.31 ng/mL, the area under the plasma-concentration-time curve (AUC0-12) was 1.44 ± 0.31 hr*ng/mL.
Maltese: (± devjazzjoni standard) kienet ta' 0.44 ± 0.31 ng/mL, l-erja taħt il-kurva tal-konċentrazzjoni filplażma-ħin (AUC0-12) kienet 1.44 ± 0.31 siegħa*ng/mL.
English: Alu / Alu-blister.
Maltese: Folja tal-Alu / Alu.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Dr. Falk Pharma GmbH
Maltese: FIS-SUQ Dr. Falk Pharma GmbH
English: Some glucocorticoids have been reported to produce cleft palate in animals.
Maltese: Ċerti kortikosterojdi ġew irrappurtati li jipproduċu cleft palate fl-annimali.
English: Marketing Authorisation Holder and Manufacturer Dr. Falk Pharma GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Dr. Falk Pharma GmbH
English: Budesonide had no mutagenic effects in a number of in vitro and in vivo tests.
Maltese: Budesonide ma kellu l-ebda effett mutaġeniku f'numru ta' testijiet in vitro u in vivo.
English: White, round, biplane orodispersible tablet, with diameter of 7.1 mm and height of 2.2 mm.
Maltese: Pillola li tinħall fil-ħalq bajda, tonda, bipjana b'dijametru ta' 7.1 mm u għoli ta' 2.2 mm.
English: Blood cortisol decreased
Maltese: Kortisol fid-demm imnaqqas
English: Single dose pharmacokinetic data in fasted patients with EoE are available with 4 mg budesonide: Median lag-time was 0.00 hours (range 0.00 - 0.17), median time to peak plasma concentration was 1.00 hour (range 0.67 - 2.00 hours); peak plasma concentration was 2.56 ± 1.36 ng/mL, and AUC0-12 was 8.96 ± 4.21 hr*ng/mL.
Maltese: Ilħin tal-intervall medjan kien ta' 0.00 sigħat (firxa 0.00 - 0.17), il-ħin medjan sal-ogħla konċentrazzjoni fil-plażma kien ta' siegħa (firxa 0.67 - sagħtejn); l-ogħla konċentrazzjoni fil-plażma kienet ta' 2.56 ± 1.36 ng/mL, u l-AUC0-12 kienet 8.96 ± 4.21 siegħa*ng/mL.
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, corticosteroids acting locally, ATC code: A07EA06
Maltese: Sustanzi kontra d-dijarea, sustanzi intestinali anti-infjammatorji/anti infettivi, kortikosterojdi li jaġixxu lokalment, Kodiċi ATC:
English: Other medicines and Jorveza
Maltese: Mediċini oħra u Jorveza
English: What Jorveza contains - The active substance is budesonide.
Maltese: - Is-sustanza attiva hi budesonide.
English: This medicine contains 52 mg sodium (main component of cooking/table salt) per daily dose.
Maltese: Din il-mediċina fiha 52 mg ta' sodium (komponent prinċipali tal-melħ tat-tisjir) f'kull doża ta' kuljum.
English: Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
Maltese: Riskju miżjud ta' trombożi, vaskulite (sindrome ta' rtirar wara terapija fit-tul)
English: The following side effects have been reported during the use of Jorveza:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati waqt l-użu ta' Jorveza:
English: The median elimination half-life is 2 - 3 hours in healthy subjects (receiving 1 mg budesonide) and 4 - 5 hours in EoE patients (receiving 4 mg budesonide).
Maltese: Il-half-life tal-eliminazzjoni medja hija ta' sagħtejn - 3 sigħat f'individwi b'saħħithom (li jirċievu 1 mg budesonide) u 4 - 5 sigħat f'pazjenti b'EoE (li jirċievu 4 mg budesonide).
English: Do not take Jorveza
Maltese: Tiħux Jorveza
English: Systemic effects of glucocorticosteroids (e.g., Cushing's syndrome, adrenal suppression, growth retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric effects) may occur (see also section 4.8).
Maltese: Jistgħu jseħħu effetti sistemiċi tal-glukokortikosterojdi (eż., is-sindrome ta' Cushing, soppressjoni adrenali, dewmien fl-iżvilupp, katarretta, glawkoma, tnaqqis fid-densità tal-minerali tal-għadam u firxa wiesgħa ta' effetti psikjatriċi) (ara wkoll sezzjoni 4.8).
English: In clinical studies conducted with Jorveza oral, oropharyngeal and esophageal candida infections have been observed with a high frequency (see section 4.8).
Maltese: Fi studji kliniċi li twettqu b'Jorveza, infezzjonijiet orali, orofarinġali u esofagali kkawżati minn candida kienu osservati bi frekwenza għolja (ara sezzjoni 4.8).
English: Co-treatment with potent CYP3A inhibitors such as ketoconazole, ritonavir, itraconazole, clarithromycin, cobicistat and grapefruit juice may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions.
Maltese: Il-kura fl-istess ħin b'impedituri qawwija ta' CYP3A bħal ketoconazole, ritonavir, itraconazole, clarithromycin, cobicistat u l-meraq tal-grejpfrut jistgħu jikkawżaw żieda sinifikanti filkonċentrazzjoni ta' budesonide fil-plażma u hija mistennija li żżid ir-riskju ta' reazzjonijiet avversi sistemiċi.
English: Each orodispersible tablet contains 26 mg sodium.
Maltese: Kull pillola li tinħall fil-ħalq fiha 26 mg sodium.
English: − diuretics (to remove excess fluid from the body).
Maltese: − dijuretiċi (għat-tneħħija ta' fluwidu żejjed mill-ġisem).
English: Children and adolescents
Maltese: fl-adolexxenti
English: Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi osservati fi studji kliniċi b'Jorveza huma elenkati fit-tabella hawn taħt, skont is-sistema ta' klassifika tal-organi u l-frekwenza MedDRA.
English: − blurred vision
Maltese: - vista mċajpra
English: The following known adverse reactions of the therapeutic class (corticosteroids, budesonide) could also occur with Jorveza (frequency = not known).
Maltese: Ir-reazzjonijiet avversi magħrufa tal-klassi terapewtika (kortikosterojdi, budesonide) li ġejjin jistgħu jseħħu wkoll b'Jorveza (frekwenza = mhux magħrufa).
English: Cardiac glycosides
Maltese: Glikosidi tal-qalb
English: No budesonide, but only budesonide metabolites were detected in urine.
Maltese: Fl-awrina ma kienx identifikat budesonide, iżda metaboliti ta' budesonide biss.
English: − increased risk of infection
Maltese: - żieda fir-riskju ta' infezzjoni
English: In a randomised, placebo-controlled, double-blind phase III clinical study including 88 adult patients with active EoE (randomisation rate: 2:1), 1 mg budesonide given twice daily as an orodispersible tablet for 6 weeks induced clinico-pathologic remission (defined as both peak of < 16 eosinophils/mm2 high power field in esophageal biopsies and no or only minimal symptoms of dysphagia or pain during swallowing) in 34 out of 59 patients (57.6%) versus 0/29 patients (0%) in the placebo-group.
Maltese: 2:1), 1 mg budesonide mogħti darbtejn kuljum bħala pillola li tinħall fil-ħalq għal 6 ġimgħat induċa remissjoni kliniko-patoloġika (definita kemm bħala livell massimu ta' < 16 eżinofili/mm2 ta' kamp enerġetiku għoli fil-bijopsiji esofagali kif ukoll bħala l-ebda sintomu jew sintomi minimi ta' disfaġja jew uġigħ wara li tibla') f'34 minn 59 pazjent
English: − tiredness
Maltese: Pożoloġija
English: Each orodispersible tablet contains 1 mg of budesonide.
Maltese: Kull pillola li tinħall fil-ħalq fiha 1 mg budesonide.
English: Patients showed a 35% increase in peak plasma concentrations and a 60% increase in AUC0-12 compared to healthy subjects.
Maltese: Il-pazjenti wrew żieda fil-konċentrazzjonijiet massimi fil-plażma ta' 35% u żieda fl-AUC0-12 ta' 60%
English: In the clinical study BUL-1/EEA, a total of 10 out of 87 patients (11.5%) exposed to Jorveza (double-blind and open-label extension phase) experienced cases of suspected fungal infections associated with clinical symptoms, which were all of mild intensity, except in one patient for whom a moderate intensity was reported.
Maltese: (11.5%) esposti għal Jorveza (fażi ta' estensjoni double-blind u open-label) kellhom każijiet ta' suspett ta' infezzjonijiet fungali assoċjati ma' sintomi kliniċi, li kienu kollha ta' intensità ħafifa, ħlief f'pazjent wieħed li għalih ġiet irrappurtata intensità moderata.
English: The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Jorveza fit-tfal u adolexxenti li għandhom inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Jorveza is not recommended for use in patients with severe renal impairment.
Maltese: Jorveza fih is-sustanza attiva budesonide, mediċina kortikosterojda li tnaqqas l-infjammazzjoni.
English: However, no systematic data are available.
Maltese: Madankollu, m'hemmx dejta sistematika disponibbli.