FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Accord has been shown to be comparable to Vimpat.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, f'konformità mar-rekwiżiti tal-UE, Lacosamide Accord intwera li huwa komparabbli ma' Vimpat.
English: How has Lacosamide Accord been studied?
Maltese: Kif ġie studjat Lacosamide Accord?
English: The Agency recommended that Lacosamide Accord be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Lacosamide Accord ikun approvat għall-użu fl-UE.
English: What are the benefits and risks of Lacosamide Accord?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Lacosamide Accord?
English: Lacosamide Accord lacosamide
Maltese: Kif jintuża Lacosamide Accord?
English: How is Lacosamide Accord used?
Maltese: Kif jaħdem Lacosamide Accord?
English: As for every medicine, the company provided studies on the quality of Lacosamide Accord.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Lacosamide Accord.
English: • The active substance is mometasone furoate.
Maltese: • Is-sustanzza attiva hi mometasone furoate.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100).
English: Dispersable cellulose (microcrystalline cellulose and carmellose sodium) Glycerol
Maltese: Cellulose li jixtered (microcrystalline cellulose u carmellose sodium) Glycerol
English: 140 actuations
Maltese: 60 attwazzjoni 140 attwazzjoni
English: Epistaxis*
Maltese: Epistassi*
English: Repeat steps 3 to 6 for the other nostril (Figure 3).
Maltese: Irrepeti l-passi minn 3 sa 6 għall-minfes l-ieħor (Figura 3).
English: Systemic Effects of Corticosteroids
Maltese: Effetti Sistemiċi tal-Koritkosterojdi
English: Nasal Spray, Suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Sprej tal-Imnieħer, Suspensjoni.
English: Mometasone furoate (as the monohydrate) 50 micrograms/actuation.
Maltese: U KWANTITATTIVA Mometasone furoate (bħala l-monohydrate) 50 mikrogramma/attwazzjoni.
English: INFORMATION IN BRAILLE Nasonex 50 µg nasal spray [To be completed nationally]
Maltese: INFORMAZZJONI BIL-BRAILLE Nasonex 50 µg sprej tal-imnieħer [Biex timtela mill-pajjiż partikolari]
English: Also contains : dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.
Maltese: Fih ukoll: cellulose li jinxtered, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, ilma ppurifikat.
English: Nasonex is not recommended in case of nasal septum perforation (see section 4.8).
Maltese: Nasonex mhuwiex irrakkomadat f'każ li jkun hemm perforazzjoni fis-septum tal-imnieħer (ara sezzjoni 4.8).
English: Adverse reactions are listed according to MedDRA primary system organ class.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-klassi primarja tas-sistemi u tal-organi MedDRA.
English: Hypersensitivity to the active substance, mometasone furoate, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, mometasone furoate, jew għal kwalunkwe wieћed milleċċipjenti elenkati fis-sezzjoni 6.1.
English: Preclinical studies demonstrate that mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity but, like other glucocorticoids, it exhibits some antiuterotrophic activity and delays vaginal opening in animal models at high oral doses of 56 mg/kg/day and 280 mg/kg/day.
Maltese: Studji ta' qabel l-istudji kliniċi urew li mometasone furoate m'għandux attività androġenika, antiandroġenika, estroġenika, jew antiestroġenika iżda, bħal glukokortikojdi oħra, huwa juri xi attività antiuterotrofika u jdewwem il-ftuħ tal-vaġina f'mudelli ta' annimali b'dożi għoljin ta' 56 mg/kg/jum u 280 mg/kg/jum mill-ħalq.
English: Each spray contains 50 micrograms of mometasone furoate, as the monohydrate.
Maltese: Kull sprejjatura fiha 50 mikrogramma ta' mometasone furoate, bħala l-monohydrate.
English: In cell culture, mometasone furoate demonstrated high potency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNFα; it is also a potent inhibitor of leukotriene production.
Maltese: F'koltura ta' ċelluli, mometasone furoate wera qawwa kbira fl-inibizzjoni tas-sintesi u r-rilaxx ta' IL-1, IL-5, IL-6 u TNFα; huwa wkoll inibitur qawwi tal-produzzjoni ta' lewkotrajin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON NASONEX 50 µg/actuation 60 and 140 actuations
Maltese: KARTUNA NASONEX 50 µg/attwazzjoni 60 u 140 attwazzjoni
English: Nasonex contains benzalkonium chloride
Maltese: Nasonex fih benzalkonium chloride
English: The carcinogenicity potential of inhaled mometasone furoate (aerosol with CFC propellant and surfactant) at concentrations of 0.25 to 2.0 micrograms/l was investigated in 24-month studies in mice and rats.
Maltese: Il-possibbiltà li mometasone furoate li jinġibed man-nifs (aerosol b'gass ikkompressat CFC u surfactant) jikkawża kanċer fil-konċentrazzjonijiet ta' 0.25 sa 2.0 mikrogramma/l ġiet investigata fi studji ta' 24 xahar fil-ġrieden u l-firien.
English: Hypersensitivity including anaphylactic reactions, angioedema, bronchospasm, and dyspnoea
Maltese: Sensittività eċċessiva inkluż reazzjonijiet anafilattiċi,
English: In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
Maltese: (6%), uġigħ ta' ras (3%), irritazzjoni fl-imnieħer (2%) u għatis (2%) kienet kumparabbli mal-plaċebo.
English: A clinical interaction study was conducted with loratadine.
Maltese: Studju kliniku ta' interazzjoni sar b'loratadine.
English: This medicinal product contains 0.02 mg of benzalkonium chloride per actuation.
Maltese: Dan il-prodott mediċinali fih 0.02 mg ta' benzalkonium chloride f'kull attwazzjoni.
English: Nasonex Nasal Spray contains mometasone furoate, one of a group of medicines called corticosteroids.
Maltese: L-Isprej tal-Imnieħer NASONEX fih mometasone furoate, wieħed minn grupp ta' mediċini msejħa kortikosterojdi.
English: In a study involving 48 children aged 3 to 5 years treated with intranasal mometasone furoate 50, 100 or 200 µg/day for 14 days, there was no significant differences from placebo in the mean change in plasma cortisol level in response to the tetracosactrin stimulation test.
Maltese: Fi studju li kien jinvolvi 48 tifel u tifla b'etajiet minn 3 sa 5 snin ittrattati b'50, 100 jew 200 µg/kuljum mometasone furoate ġol-imnieħer għal 14-il jum, ma kien hemm l-ebda differenzi sinifikanti mill-plaċebo fil-medja ta' bidla tal-livell ta' kortisol fil-plażma b'rispons għat-test ta' stimulazzjoni b'tetracosactrin.
English: After initial priming of the NASONEX Nasal Spray pump, each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.
Maltese: Wara l-ipprajmjar tal-pompa tal-Isprej tal-Imnieħer NASONEX għall-ewwel darba, kull attwazzjoni tagħti madwar 100 mg ta' suspensjoni ta' mometasone furoate, li fiha mometasone furoate monohydrate ekwivalenti għal 50 mikrogramma mometasone furoate.
English: What is Nasonex?
Maltese: Nasonex.
English: This has been demonstrated by decreases (vs placebo) in histamine and eosinophil activity and reductions (vs baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins.
Maltese: Dan intwera permezz ta' tnaqqis (vs plaċebo) fl-attività tal-istamina u l-eosinofili u tnaqqis (vs il-linja bażi) fleosinofili, fin-newtrofili u fil-proteini ta' adeżjoni taċ-ċelluli tal-epitelju.
English: The median (50%) onset time of relief was 35.9 hours.
Maltese: Il-medjan (50%) ta' żmien għall-bidu ta' serħan mis-sintomi kien 35.9 sigħat.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tiġi aġġornata sussegwentament mill-awtoritajiet kompetenti tal-Istati Membri, b'kollaborazzjoni mal-Istat Membru ta' Riferenza, kif xieraq, skont il-proċedura stabbilita fil-Kapitolu 4 tat-Titlu III tad-Direttiva 2001/83/KE.
English: Within each system organ class, adverse reactions are ranked by frequency.
Maltese: F'kull klassi tas-sistemi u tal-organi, ir-reazzjonijiet avversi huma kklassifikati skont il frekwenza.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Maltese: Id-doża għandha titnaqqas bil-mod sal-inqas doża li biha jibqa' jkun hemm kontroll effettiv tas-sintomi.
English: In 28% of the patients with seasonal allergic rhinitis, NASONEX Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose.
Maltese: Fi 28% tal-pazjenti b'rinite allerġika tal-istaġun, l-Isprej tal-Imnieħer NASONEX wera bidu ta' azzjoni sinifikanti b'mod kliniku fi żmien 12-il siegħa wara l-ewwel doża.
English: Table 1:
Maltese: (Figura 1)
English: Throat irritation*
Maltese: Irritazzjoni fil gerżuma*
English: In addition, it is an extremely potent inhibitor of the production of the Th2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.
Maltese: Barra dan, huwa inibitur potenti b'mod esterm tal-produzzjoni taċ-ċitokini Th2, IL-4 u IL-5, miċ-ċelluli T CD4+ tal-bniedem.
English: • The other ingredients are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate,
Maltese: • Is-sustanzi l-oħra huma cellulose li jixtered, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, ilma ppurifikat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each metered actuation delivers 50 µg mometasone furoate.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull attwazzjoni mkejla tagħti 50 µg mometasone furoate.
English: Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Maltese: katarretti, glawkoma u b'mod aktar rari, firxa ta' effetti fiżjoloġiċi jew ta' komportament inkluż attività psikomotorja eċċessiva, disturbi fl-irqad, ansjetà, depressjoni jew aggressjoni (b'mod partikolari fit-tfal).
English: Use in adults over 18 years old
Maltese: Użu fl-adulti li għandhom aktar minn 18-il sena
English: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Maltese: Mometasone furoate huwa glukokortikosterojd topiku bi proprjetajiet anti-infjammatorji lokali f'dożi li mhumiex attivi b'mod sistemiku.
English: Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml.
Maltese: fil-plażma, bl-użu ta' assaġġ sensittiv bil-limitu l-aktar baxx ta' kwantitazzjoni ta' 0.25 pg/ml.
English: Glaucoma
Maltese: Tfal
English: If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Maltese: Jekk ikun hemm xhieda għal użu ta' dożi aktar minn dawk irrakkomandati, imbagħad għandu jitqies ilqugħ addizzjonali b'kortikosterojd sistemiku waqt perjodi ta' stress jew ta' kirurġija elettiva.
English: There are limited data available on the safety and efficacy of NASONEX Nasal Spray in the paediatric population aged 3 to 5 years, and an appropriate dosage range cannot be established.
Maltese: Hemm disponibbli dejta limitata fuq is-sigurtà u l-effikaċja tal-Isprej tal-Imnieħer NASONEX filpopolazzjoni pedjatrika mill-età ta' 3 sa 5 snin, u firxa ta' dożaġġ xieraq ma tistax tiġi determinata.
English: Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids, ATC code: R01A D09
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati marbuta mat-trattament skont il-klassi tas-sistemi u talorgani u l-frekwenza
English: NASONEX Nasal Spray should not be used in the presence of untreated localised infection involving the nasal mucosa, such as herpes simplex.
Maltese: L-Isprej tal-Imnieħer NASONEX m'għandux jintuża fil-preżenza ta' infezzjoni lokali mhux ittrattata li tinvolvi l-mukuża tal-imnieħer, bħal herpes simplex.
English: NASONEX Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.
Maltese: Nasonex jintuża biex jittratta polipi fl-imnieħer f'adulti li għandhom 18-il sena u aktar.
English: How to use Nasonex
Maltese: Tużax Nasonex
English: Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%) as reported in clinical studies for allergic rhinitis.
Maltese: L-epistassi ġeneralment għaddiet waħedha u kienet ħafifa fil-qawwa tagħha, u seħħet b'inċidenza ogħla meta mqabbla mal-plaċebo (5%), iżda b'inċidenza komparabbli jew b'inċidenza inqas meta mqabbla malkontroll attiv ta' kortikosterojdi mill-imnieħer li ġew studjati (sa 15%) kif ġie rrappurtat fl-istudji kliniċi għal rinite allerġika.
English: Typical glucocorticoid-related effects, including several non-neoplastic lesions, were observed.
Maltese: Ġew osservati effetti tipiċi marbuta mal-glukokortikojdi, fosthom diversi leżjonijiet li ma kinux neoplastiċi.
English: Dose reduction is recommended following control of symptoms.
Maltese: Huwa rrakkomandat tnaqqis fid-doża wara li jinkiseb kontroll tas-sintomi.
English: It is very important that you use your nasal spray regularly.
Maltese: Huwa importanti ħafna li inti tuża l isprej tal-imnieħer b'mod regolari.
English: Persistence of nasopharyngeal irritation may be an indication for discontinuing NASONEX Nasal Spray.
Maltese: Il-persistenza ta' irritazzjoni tal-imnieħer u l-farinġi tista' tkun indikazzjoni biex wieħed iwaqqaf l-Isprej tal-Imnieħer NASONEX.
English: The usual recommended starting dose for polyposis is two actuations (50 micrograms/actuation) in each nostril once daily (total daily dose of 200 micrograms).
Maltese: Id-doża rrakkomandata s-soltu hija żewġ attwazzjonijiet (50 mikrogramma/attwazzjoni) f'kull minfes darba kuljum (doża totali 200 mikrogramma).
English: Nasonex contains benzalkonium chloride which may cause nasal irritation.
Maltese: Nasonex fih benzalkonium chloride li jista' jikkawża irritazzjoni fl-imnieħer.
English: The safety and efficacy of NASONEX Nasal Spray has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
Maltese: Is-sigurtà u l-effikaċja tal-Isprej tal-Imnieħer NASONEX ma ġewx studjati għall-użu fit-trattament ta' polipi unilaterali, polipi assoċjati ma' fibrożi ċistika, jew polipi li jagħlqu kompletament il-kavitajiet tal-imnieħer.
English: Because the systemic bioavailability of NASONEX Nasal Spray is <1%, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.
Maltese: Minħabba li l-biodisponibbiltà sistemika tal-Isprej tal-Imnieħer NASONEX hija <1%, doża eċċessiva mhijiex probabbli li tkun teħtieġ xi terapija ħlief osservazzjoni, segwita minn bidu tad-dożaġġ xieraq ordnat.
English: Nasonex and associated names strength pharmaceutical form [See Annex I - To be completed nationally] Mometasone Furoate
Maltese: [Ara Anness I- Biex timtela mill-pajjiż partikolari] Dan il-fuljett kien rivedut l-aħħar f' [Biex timtela mill-pajjiż partikolari]
English: Epistaxis Nasal burning Nasal irritation Nasal ulceration
Maltese: Kif għandek tuża Nasonex
English: White to off-white opaque suspension.
Maltese: Suspensjoni opaka minn bajda sa ofwajt.
English: Epistaxis was generally self-limiting and mild in severity (see section 4.8).
Maltese: L-epistassi ġeneralment waqfet waħedha u kienet ħafifa fil-qawwa tagħha (ara sezzjoni 4.8).
English: Following 12 months of treatment with NASONEX Nasal Spray in a study of patients with perennial rhinitis, there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype.
Maltese: Wara 12-il xahar ta' trattament bl-Isprej tal-Imnieħer NASONEX fi studju ta' pazjenti b'rinite ta' matul is-sena kollha, ma kien hemm l-ebda evidenza ta' atrofija tal-mukuża tal-imnieħer; ukoll, mometasone furoate kellu tendenza li jreġġa' lura l-mukuża tal-imnieħer biex tiġi eqreb għall-fenotip istoloġiku normali.
English: NASONEX Nasal Spray is indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.
Maltese: Nasonex jintuża biex jittratta s-sintomi tal-hay fever (imsejjaħ ukoll rinite allerġika tal-istaġun) u rinite ta' matul is-sena kollha fl-adulti u fit-tfal li għandhom 3 snin u aktar.
English: No interactions were observed.
Maltese: Ma kienu osservati l-ebda interazzjonijiet.
English: Elimination Absorbed mometasone furoate is extensively metabolized and the metabolites are excretedin urine and bile.
Maltese: Mometasone furoate li jiġi assorbit jiġi mmetabolizzat b'mod estensiv u l-metaboliti jitneħħew mal awrina u mal-bajl.
English: All observed effects are typical of this class of compounds and are related to exaggerated pharmacologic effects of glucocorticoids.
Maltese: L-effetti kollha osservati huma tipiċi għal din il-klassi ta' komposti u huma marbuta ma' effetti farmakoloġiċi esaġerati ta'
English: NASONEX Nasal Spray contains benzalkonium chloride which may cause nasal irritation.
Maltese: L-Isprej tal-Imnieħer NASONEX fih benzalkonium chloride li jista' jikkawza irritazzjoni fl-imnieħer.
English: How to store Nasonex
Maltese: Mediċini oħra u Nasonex
English: Respiratory, thoracic and mediastinal disorders
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Treatment of Hayfever and Perennial Rhinitis
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: Nasal Polyps
Maltese: Polipi fl-Imnieħer
English: The European Medicines Agency has waived the obligation to submit the results of studies with NASONEX Nasal Spray and associated names in all subsets of the paediatric population in seasonal and perennial allergic rhinitis (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: LABELLING
Maltese: Epistassi
English: Children between the ages of 3 and 11 years: The usual recommended dose is one actuation (50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).
Maltese: Id-doża rrakkomandata s-soltu hija attwazzjoni waħda (50 mikrogramma/attwazzjoni) f'kull minfes darba kuljum (doża totali 100 mikrogramma).
English: Common side effects (may affect up to 1 in 10 people): headache sneezing nose bleeds [occurred very commonly (may affect more than1 in 10 people) in people with nasal polyps receiving Nasonex two sprays in each nostril twice a day] sore nose or throat ulcers in the nose respiratory tract infection
Maltese: Bħal fil-każ ta' preparazzjonijiet oħra ta' kortikosterojdi mill-imnieħer, għandha tittieħed deċiżjoni jekk il-mara twaqqafx it-treddigħ jew twaqqafx it-trattament bl-Isprej tal-Imnieħer NASONEX, wara li jiġi kkunsidrat il-benefiċċju ta' treddigħ għat-tarbija u l-benefiċċu tat-trattament għall-mara.
English: if you have cystic fibrosis.
Maltese: • jekk inti għandek fibrożi ċistika.
English: Lactation
Maltese: Distribuzzjoni
English: Pharyngitis
Maltese: Treddigħ
English: What Nasonex looks like and contents of the pack Nasonex is a nasal spray suspension.
Maltese: Nasonex huwa suspensjoni ta' sprej għall-imnieħer.
English: swollen face, tongue or pharynx trouble swallowing hives wheezing or trouble breathing
Maltese: Hay fever u rinite ta' matul is-sena kollha
English: Treatment related adverse reactions (≥1%) reported in clinical trials in patients with allergic rhinitis or nasal polyposis and post-marketing regardless of indication are presented in Table 1.
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella Reazzjonijiet avversi marbuta mat-trattament (≥1%) irrappurtati fi provi kliniċi f'pazjenti b'rinite allerġika jew polipożi fl-imnieħer u wara t-tqegħid fis-suq irrispettivament mill-indikazzjoni huma ppreżentati f'Tabella 1.
English: Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may be effective for maintenance.
Maltese: Ladarba s-sintomi jkunu kkontrollati, tnaqqis fid-doża għal attwazzjoni waħda f'kull minfes (doża totali 100 mikrogramma) jista' jkun effettiv għat-tkomplija tat-trattament.
English: Treatment with NASONEX Nasal Spray may need to be initiated some days before the expected start of the pollen season in patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis.
Maltese: F'pazjenti ttrattatti għal polipożi fl-imnieħer, l-inċidenza globali ta' każijiet avversi kienet tixbah lil dik osservata f'pazjenti b'rinite allerġika.
English: LIST OF EXCIPIENTS Contains benzalkonium chloride
Maltese: Fih benzalkonium chloride
English: Nasal septum perforation
Maltese: Effetti Lokali fl-Imnieħer
English: “not known (cannot be estimated from the available data)”.
Maltese: Il-frekwenza tal-każijiet avversi wara t-tqegħid fis-suq hija meqjusa bħala “mhux magħrufa” (ma tistax tittieħed stima mid-dejta disponibbli)”.
English: Nasonex is used to treat the symptoms of hayfever (also called seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 and older.
Maltese: Rinite Allerġika tal-Istaġun jew Rinite ta' Matul is-Sena Kollha Adulti (inkluż pazjenti akbar fl-età) u tfal ta' 12-il sena u aktar:
English: Not known
Maltese: Immaniġġjar
English: Like other glucocorticoids, mometasone furoate showed a clastogenic potential in-vitro at high concentrations.
Maltese: Bħal fil-każ ta' glukokortikojdi oħra, mometasone furoate wera potenzjal klastoġeniku in-vitro f'konċentrazzjonijiet qawwija.
English: However, patients who are transferred from long-term administration of systemically active corticosteroids to NASONEX Nasal Spray require careful attention.
Maltese: kortikosterojdi attivi b'mod sistemiku għall-Isprej tal-Imnieħer NASONEX jeħtieġu attenzjoni bir-reqqa.
English: Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Maltese: Il-pazjenti li jkunu qed jirċievu kortikosterojdi li għandhom possibbiltà jkunu immunosoppressi għandhom jiġu mwissija dwar ir-riskju ta' esponiment għal ċerti infezzjonijiet (eż., ġidri r-riħ, ħosba) u l importanza li jinkiseb parir mediku jekk iseħħ esponiment bħal dan.
English: Plenadren hydrocortisone
Maltese: Plenadren idrokortiżon
English: It is available as modified-release tablets (5 mg and 20 mg).
Maltese: Jiġi f'pilloli tondi b'rilaxx modifikat (5 mg u 20 mg).
English: The full EPAR for Plenadren 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: Other information about Plenadren
Maltese: Informazzjoni oħra dwar Plenadren
English: Plenadren contains the active substance hydrocortisone.
Maltese: Plenadren fih is-sustanza attiva idrokortiżon.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Plenadren on 3 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Plenadren fit-3 ta' Novembru 2011.