FrancophonIA/ELRC3.0 huggingface dataset:
English: Reteplase activates the production of an enzyme called plasmin, which breaks up blood clots.
Maltese: Reteplażi jattiva l-produzzjoni ta' enzima msejħa plasmina, li tkisser l-emboli tad-demm.
English: What is Rapilysin?
Maltese: Kif jaħdem Rapilysin?
English: The studies looked at the number of patients who had died 30 to 35 days after treatment, and at the number of patients who had heart failure (an inability of the heart to pump enough blood around the body) or a stroke.
Maltese: L-istudji ħarsu lejn għadd ta' pazjenti li kienu mietu 30 sa 35 jum wara l-kura, u l-għadd ta' pazjenti li kellhom insuffiċjenza kardijaka (in-nuqqas ta' kapaċità tal-qalb biex tippompja biżżejjed demm madwar il-ġisem) jew puplesija.
English: The active substance in Rapilysin, reteplase, is a copy of a natural enzyme called t-PA that has been modified so that it starts working faster and for longer.
Maltese: Is-sustanza attiva f'Rapilysin, ir-reteplażi, hija kopja ta' enzima naturali li tissejjaħ t-PA li ġiet modifikata biex tibda taħdem b'mod aktar mgħaġġel u għal aktar fit-tul.
English: Other medicines that prevent clotting (aspirin and heparin) should be given before and after the Rapilysin injection to stop clots from forming again.
Maltese: Mediċini oħra li jipprevjenu l-koagulazzjoni (l-aspirina u l-eparina) għandhom jingħataw qabel u wara l-injezzjoni ta' Rapilysin biex iwaqqfu l-emboli milli jerġgħu jifformaw.
English: What is the risk associated with Rapilysin?
Maltese: X'inhu r-riskju assoċjat ma' Rapilysin?
English: Each injection is given into a vein slowly, but in less than two minutes.
Maltese: Kull injezzjoni tingħata fil-vina bil-mod, iżda f'inqas minn żewġ minuti.
English: Rapilysin must also not be used in patients who are at risk of bleeding because of other diseases, treatment with other medicines, high blood pressure, previous bleeding or recent surgery.
Maltese: Rapilysin għandu jintuża wkoll f'pazjenti li qegħdin f'riskju ta' fsada minħabba mard ieħor, kura b'mediċini oħra, pressjoni tad-demm għolja, fsada preċedenti jew kirurġija riċenti.
English: How has Rapilysin been studied?
Maltese: Kif ġie studjat Rapilysin?
English: The CHMP decided that Rapilysin's benefits are greater than its risks for and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Rapilysin huma akbar mir-riskji tiegħu u rrakkomanda li jingħata lawtorizzazzjoni għat-tqegħid fis-suq.
English: Following a heart attack, Rapilysin can help dissolve blood clots that have formed in the arteries supplying the heart muscle, thereby restoring normal blood flow to the heart.
Maltese: Wara attakk tal-qalb, Rapilysin jista' jgħin iħoll l-emboli tad-demm li fformaw fl-arterji li jissupplixxu l-muskolu tal-qalb u b'hekk ireġġa' l-fluss lejn il-qalb għan-normal.
English: How is Rapilysin used?
Maltese: Għal xiex jintuża Rapilysin?
English: Adults and adolescents (from 12 years of age) :
Maltese: Adulti u adolexxenti (minn 12-il sena):
English: Marketing Authorisation Holder: {See ANNEX I of referal} Manufacturer: Chiesi Farmaceutici S.p.A., 26/A via Palermo, 43122 Parma, Italy.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq {Ara ANNESS I tar-referal} Manifattur: Chiesi Farmaceutici S.p.A., 26/A via Palermo, 43122 Parma, l-Italja.
English: • worsening shortness of breath, cough and wheezing (which is known as paradoxical bronchospasm).
Maltese: • aggravar ta' qtugħ ta' nifs, sogħla u tħarħir (li huwa magħruf bħala bronkospażmu paradossali).
English: {See ANNEX I of referal}
Maltese: {Ara ANNESS I tar-referal}
English: • before an operation,
Maltese: • qabel operazzjoni,
English: The active substance is beclometasone dipropionate.
Maltese: Is-sustanza attiva hi beclometasone dipropionate.
English: • sore throat (pharyngitis, laryngitis).
Maltese: • uġigħ fil-griżmejn (farinġite, larinġite).
English: {INVENTED NAME} 400 micrograms
Maltese: IVVINTAT} 400 mikrogramma
English: {INVENTED NAME} 800 micrograms
Maltese: IVVINTAT} 800 mikrogramma
English: Throat irritation, hoarseness, dysphonia, paradoxical bronchospasm, wheezing
Maltese: Irritazzjoni fil-griżmejn, ħanqa disfonja, bronkospażmu paradossali, tħarħir
English: 20 ampoules
Maltese: 20 kunjett
English: The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for BDP and B17MP respectively.
Maltese: Il bijodisponibilità assoluta wara teħid man-nifs hija madwar 2% u 62% tad-doża nominali għal BDP u B17MP rispettivament.
English: In the study 40.4% and 51.7% patients in the of nebulised beclometasone dipropionate and budesonide groups respectively did not experience any major exacerbation (primary endpoint).
Maltese: Fl-istudju 40.4% u 51.7% tal-pazjenti filgruppi ta' CLENIL u budesonide rispettivament ma kellhomx irkadar maġġuri.
English: For instruction on preparation and dilution of the medicinal product, see section 6.6.
Maltese: Għal struzzjonijiet fuq il-preparazzjoni u id-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.6.
English: • tremor (involuntary trembling)
Maltese: • rogħda (tregħid involontarju)
English: Do not use with ultrasonic nebulisers.
Maltese: Tużax flimkien ma' nebulizzaturi ultrasoniċi.
English: Strips of 5 ampoules are packed in a heat sealed pouch of PET/Al/PE (Polyethylene Terephthalate/Aluminium/Polyethylene).
Maltese: Strixxi ta' 5 kunjetti huma ppakkjati f'borża tal-PET/Al/PE (Polyethylene
English: Cataract**, glaucoma**
Maltese: Katarretti**, glawkoma*
English: Adverse reactions observed in clinical trials with inhaled beclometasone in the treatment of asthma and wheezing are listed in the table below according the MedDRA system organ class and frequencies: 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), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)..
English: Nebulised beclometasone dipropionate was evaluated in 276 children aged 1-4 years with frequent wheezing in a randomized, double-blind, 12-week controlled trial.
Maltese: CLENIL kien evalwata f'276 tifel u tifla ta' età minn sena sa 4 snin bi tħarħir frekwenti fi prova randomised, double-blind, ikkontrollata ta' 12-il ġimgħa.
English: • treatment of recurrent wheezing in children up to 5 years of age (see sections 4.2 and 4.4 paediatric population).
Maltese: • kura ta' tħarħir rikorrenti fi tfal li jkollhom sa 5 snin (ara sezzjonijiet 4.2 u 4.4 Popolazzjoni pedjatrika).
English: Beclometasone dipropionate (BDP) is a pro-drug that is hydrolysed via esterase enzymes to an active metabolite beclometasone monopropionate (B17MP) the most abundant metabolite in plasma.
Maltese: Beclometasone dipropionate (BDP) huwa pro-droga li hija idrolizzata permezz ta' enzimi esterase għall-metabolit attiv beclometasone monopropionate (B17MP) l-aktar metabolit abbundanti fil plażma.
English: Possible systemic effects include hypothalamic-pituitary-adrenal (HPA)-axis suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Maltese: Effetti sistemiċi possibbli jinkludu soppressjoni adrenali, ittardjar tat-tkabbir fi tfal u adolexxenti, tnaqqis fid-densità minerali tal-għadam, katarretti u glawkoma u aktar rari, firxa ta' effetti psikoloġiċi u ta' mġieba li jinkludu attività psikomotorja eċċessiva, disturbi fl-irqad, ansjetà, depressjoni jew aggressjoni (speċjalment fit-tfal).
English: Sorbitan laurate Sodium chloride Water for injections
Maltese: Sorbitan laurate Sodium chloride Ilma għall-injezzjoni
English: In terms of safety, no change in the values of morning salivary cortisol was detected (Papi et al., 2009).
Maltese: F'termini ta' sigurtà, ma kienet osservata l-ebda bidla fil-valuri ta' cortisol fil-bżieq filgħodu (Papi et al., 2009).
English: The benefits of breastfeeding are likely to outweigh any theoretical risk.
Maltese: Ilbenefiċċji tat-treddigħ aktarx jegħlbu kwalunkwe riskju teoretiku.
English: Reduction or withdrawal of oral corticosteroid therapy may unmask clinical features of Churg-Strauss syndrome and hyper eosinophilic state.
Maltese: Tnaqqis jew irtirar ta' terapija b'kortikosterojdi orali jista' jiżvela fatturi kliniċi tas-sindrome ChurgStrauss u stat ipereżinofiliku.
English: Nebuliser suspension.
Maltese: U KONTENUT Suspensjoni għan-nebulizzatur
English: 4.3 Contraindications 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 wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
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 tal-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, b'konformità mal proċeduri stabbiliti f'Kapitolu 4 ta' Titolu III tad-Direttiva 2001/83/KE.
English: ONLY sterile sodium chloride 9 mg/ml (0.9%) solution should be used.
Maltese: Għandha tintuża BISS soluzzjoni sterili ta' 9 mg/ml (0.9%) sodium chloride.
English: There are strips 5 ampoules in each sealed pouch, in pack sizes of 10 ampoules (2 pouches), 20 ampoules (4 pouches) or 40 ampoules (8 pouches).
Maltese: Hemm strixxi b'5 kunjetti f'kull borża ssiġillata, f'daqsijiet ta' pakketti ta' 10 kunjetti (2 boroż), 20 kunjett (4 boroż) jew 40 kunjett (8 boroż).
English: Minor inactive metabolites, beclometasone-21-monopropionate (B21MP) and beclometasone (BOH), are also formed but these contribute little to the systemic exposure.
Maltese: Jiġu ffurmati wkoll il-metaboliti inattivi minuri, beclometasone-21-monopropionate (B21MP) u beclometasone (BOH), iżda dawn ftit jikkontribwixxu għall-esponiment sistemiku.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC:
English: Nausea, dyspepsia
Maltese: Dardir, dispepsja
English: Beclometasone dipropionate undergoes a very rapid pre-systemic metabolism via esterase enzymes without involvement of cytochrome P450 system.
Maltese: Beclometasone dipropionate jgħaddi minn metaboliżmu pre-sistemiku mgħaġġel ħafna permezz ta' enzimi esterase mingħajr ma tiġi nvoluta s-sistema taċ-ċitokromu P450.
English: In healthy males a single dose of 1600 µg beclometasone dipropionate by nebulisation had no effect on 24-h urinary cortisol excretion, while a single dose of 3200 µg produced a urinary cortisol excretion reduction of about 10% without any significant differences between the two dosage treatments.
Maltese: Ġie muri li f'individwi f'saħħithom, doża ta' 1600 µg ta' BDP permezz ta' nebulizzazzjoni ma kellha l-ebda effett fuq it-tneħħija f'24 siegħa ta' kortisol fl-awrina, filwaqt li doża ta' 3200 µg ikkawżat tnaqqis ta' madwar 10% mingħajr l-ebda differenzi sinifikanti bejn it-trattamenti.
English: Patients suffering from tuberculosis should receive tuberculostatic therapy while being treated with beclometasone propionate.
Maltese: Pazjenti li jbatu minn tuberkulosi għandhom jirċievu terapija antituberkulostatika waqt li jkunu qed jiġu ttrattati b'beclometasone dipropionate.
English: Your doctor may prescribe a course of antibiotics.
Maltese: It-tabib tiegħek jista' jippreskrivi kors ta' antibijotiċi.
English: Excipients: polysorbate 20, sorbitan laurate, sodium chloride, water for injections
Maltese: Eċċipjenti: polysorbate 20, sorbitan laurate, sodium chloride, ilma ppurifikat
English: The bioavailability of orally administered BDP is negligible but pre-systemic conversion to B17MP results in absorption of approximately 40% of the swallowed portion as B17MP.
Maltese: Il-bijodisponibilità ta' BDP mogħti mill-ħalq hija negliġibbli iżda bidla pre-sistemika għal B17MP twassal għal assorbiment ta' madwar 40% tal-porzjon li tinbela' bħala B17MP.
English: Gently squeeze the ampoule content into the nebuliser chamber (Figure E).
Maltese: Bil-mod għafas il-kontenut tal-ampulla fil-kompartiment tan-nebulizzatur (Figura E).
English: The main product of metabolism is the active metabolite (B17MP).
Maltese: Il-prodott ewlieni tal-metaboliżmu huwa l-metabolit attiv (B17MP).
English: 400-800 micrograms twice daily (total daily dose: 800 - 1600 micrograms)
Maltese: (doża totali ta' kuljum: 400 - 1600 mikrogramma)
English: The terminal elimination half-lives are 0.5 h and 2.7 h for BDP and B17MP respectively.
Maltese: Il-half-lives tal-eliminazzjoni terminali huma 0.5 sigħat u 2.7 sigħat għal BDP
English: Batch:
Maltese: Pereżempju:
English: For example:
Maltese: Jis:
English: Wheezing
Maltese: MHUX
English: CLENIL and associated names (see Annex I) 400 micrograms nebuliser suspension CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension
Maltese: CLENIL 400 mikrogramma suspensjoni għan-nebulizzatur CLENIL 800 mikrogramma suspensjoni għan-nebulizzatur
English: Nebuliser suspension 10 ampoules
Maltese: U KONTENUT Suspensjoni għan-nebulizzatur 10 kunjetti b'doża waħda
English: 400 micrograms ampoule is for single use.
Maltese: 400 mikrogramma jintuża darba.
English: LIST OF EXCIPIENTS Excipients: polysorbate 20, sorbitan laurate, sodium chloride, water for injections
Maltese: TA' EĊĊIPJENTI Eċċipjenti: polysorbate 20, sorbitan laurate, sodium chloride, ilma ppurifikat
English: PHARMACEUTICAL FORM AND CONTENTS Nebuliser suspension
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għan-nebulizzatur.
English: Hypersensitivity reactions with the following manifestations: angioedema, rash, urticaria, pruritus,
Maltese: Reazzjonijiet ta' sensittività eċċessiva bil-manifestazzjonijiet li ġejjin: anġjoedima, raxx, urtikarja, ħakk,
English: 800-1,600 micrograms twice daily (total daily dose: 1600 - 3200 micrograms)
Maltese: (doża totali ta' kuljum: 800 - 3200 mikrogramma)
English: No specific studies have been performed with beclometasone dipropionate with regard to the safety in human fertility.
Maltese: Ma twettaq l-ebda studju speċifiku b'beclometasone dipropionate rigward is-sigurtà fil-fertilità talbniedem.
English: B end the amp oule back ward s and forwards (Figure A).
Maltese: Għawweġ l-ampulla lura u 'l quddiem (Figura A).
English: Each 1 ml ampoule contains 400 micrograms beclometasone dipropionate.
Maltese: Kull kunjett ta' 1 ml fih 400 mikrogramma beclometasone dipropionate.
English: A study in which the objective was to compare the efficacy and safety of nebulised beclometasone dipropionate versus fluticasone propionate suspension for nebulization was conducted in 205 adults patients aged 18-65 years with asthma randomized to a 12-week treatment period.
Maltese: IVVINTAT} ma' suspensjoni għan-nebulizzazzjoni ta' fluticasone propionate twettaq fuq 205 pazjenti adulti ta' età minn 18-65 sena bl-ażżma randomised għal perjodu ta' trattament ta' 12-il ġimgħa.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100 persuna):
English: The most common adverse reactions observed during clinical trials using inhaled beclometasone in the treatment of asthma and wheezing were laryngitis, pharyngitis and oral candidiasis.
Maltese: L-aktar reazzjonijiet avversi komuni osservati waqt provi kliniċi kienu larinġite, farinġite u kandidjażi orali.
English: Note:
Maltese: persuni):
English: After the first opening of the ampoule, store in a refrigerator (2°C - 8°C).
Maltese: Wara li jinfetaħ għall-ewwel darba: aħżen fi friġġ (2°C - 8°C).
English: A double-blind, double-dummy, multicentre, randomized, parallel-group study compared the efficacy and safety of nebulised beclometasone dipropionate and beclometasone dipropionate administered with metered-dose inhalation in 151 patients, aged 6-16 years, with moderate to severe asthma for 4 weeks.
Maltese: Studju double-blind, double-dummy, b'aktar minn ċentru wieħed, randomised u bi grupp parallel qabbel l-effikaċja u s-sigurtà ta' CLENIL u beclomethasone dipropionate mogħtija permezz ta' teħid man-nifs ta' doża mkejla f'124 pazjent adult b'ażżma moderata sa severa.
English: Consideration can be given to referring the patient to paediatric pulmonologist.
Maltese: jikkunsidra li jirreferi lill-pazjent għand pulmunoloġista pedjatriku.
English: Beclometasone dipropionate is a glucocorticoid with potent anti-inflammatory activity with limited mineralocorticoid activity; following administration to the respiratory system by inhalation a local effect in the lower respiratory tract is obtained.
Maltese: Beclometasone dipropionate huwa glukokortikojd b'attività anti-infjammatorja qawwija b'attività mineralokortikojdi limitata; wara li jingħata fis-sistema respiratorja permezz ta' teħid man-nifs jinkiseb effett lokali fil-passaġġ respiratorju t'isfel.
English: Beclometasone dipropionate demonstrated to be non-genotoxic.
Maltese: Beclometasone dipropionate jista' jintuża waqt it-treddigħ.
English: Each 2 ml ampoule contains 800 micrograms beclometasone dipropionate.
Maltese: Kull kunjett ta' 2 ml fih 800 mikrogramma beclometasone dipropionate.
English: • throat irritation, hoarse voice
Maltese: • irritazzjoni fil-griżmejn, ħanqa
English: The pharmacokinetics of BDP in patients with renal or hepatic impairment has not been studied; however, as BDP undergoes a very rapid metabolism via esterase enzymes present in intestinal fluids, serum, lungs and liver to originate more polar products B21MP, B17MP and BOH, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of BDP.
Maltese: madankollu, peress li BDP jgħaddi minn metaboliżmu mgħaġġel ħafna permezz ta' enzimi esterase preżenti fil-fluwidi intestinali, fis-serum, fil-pulmuni u fil-fwied biex joriġinaw il-prodotti aktar polari B21MP, B17MP u BOH, indeboliment tal-fwied mhux mistenni li jimmodifika l-profil farmakokinetiku u tas-sigurtà ta' BDP.
English: No formal pharmacokinetic drug-drug interaction studies have been conducted.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni farmakokinetika bejn mediċina u oħra.
English: Special care is necessary in patients with active or quiescent pulmonary tuberculosis and other infections.
Maltese: Attenzjoni speċjali hija meħtieġa f'pazjenti b'tuberkulosi pulmonari attiva jew inattiva u infezzjonijiet oħra.
English: Nebulisation should not last more than 10 to 15 minutes.
Maltese: In-nebulizzazzjoni m'għandhiex iddum aktar minn 10 sa 15-il minuta.
English: 5 ampoules containing 1 ml suspension each
Maltese: 5 kunjetti ta' doża waħda li fihom 1 ml ta' suspensjoni f'kull wieħed
English: *Rare
Maltese: Rari
English: The recommended initial doses are:
Maltese: Id-dożi inizjali rakkomandati huma:
English: Replacement of systemic steroid treatment with inhaled therapy sometimes also unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic medicinal product.
Maltese: Sostituzzjoni ta' trattament ta' sterojdi sistemiċi b'terapija meħuda man-nifs kultant tiżvela wkoll allerġiji bħal rinite allerġika jew ekżema li qabel kienu ikkontrollati mill-prodott mediċinali sistemiku.
English: A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.
Maltese: Reazzjoni ta' sensittività eċċessiva serja inkluża edima tal-għajnejn, wiċċ, xufftejn u griżmejn (anġjodima) kienet irrappurtata b'mod rari.
English: Exp:
Maltese: Tfal:
English: This affection generally responds to a suitable topical antimycotic therapy, without discontinuing the treatment with beclometasone dipropionate.
Maltese: Din l-infezzjoni ġeneralment tirrispondi għal terapija antimikotika topika adattata, mingħajr waqfien tat-trattament b'beclometasone dipropionate.
English: Rare side effects (may affect up to 1 in 1000people):
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1000):
English: Comparable efficacy in controlling asthma was demonstrated by the two treatments at study end in terms of pulmonary function tests, asthma exacerbations, symptoms and the use of rescue salbutamol (Terzano et al., 2003).
Maltese: Intweriet effikaċja komparabbli fil kontroll tal-ażżma miż-żewġ trattamenti fl-aħħar tal-istudju f'termini ta' testijiet tal-funzjoni pulmonari, irkadar tal-ażżma, sintomi u l-użu ta' salbutamol bħala salvataġġ.
English: No evidence of carcinogenicity was observed in a 95-week study in rats treated by inhalation.
Maltese: Ma kinitx osservata evidenza ta' karċinoġeniċità fi studju ta' 95 ġimgħa fil-firien ittrattati permezz ta' teħid man-nifs.
English: * from spontaneous reporting **systemic effects of inhaled corticosteroids
Maltese: ** effetti sistemiċi ta'kortikosterojdi meħuda man-nifs
English: {INVENTED NAME} nebuliser suspension comes in polyethylene ampoules containing 1 ml ({INVENTED NAME} 400 micrograms) or 2 ml ({INVENTED NAME} 800 micrograms).
Maltese: L-ampulla ta' doża waħda ta' 2 ml għandha marka ta' gradazzjoni biex tindika nofs il-kontenut (li tikkorrispondi għal 400 mikrogramma).
English: The affinity of beclometasone dipropionate and its main active metabolite, beclometasone monopropionate (B17MP), for the human glucocorticoid receptor has been determined.
Maltese: Ġiet determinata l-affinità ta' beclometasone dipropionate u tal-metabolit attiv prinċipali tiegħu beclometasone monopropionate (B17MP) għar-riċettur glukokortikojd uman.
English: Regular nebulised beclometasone dipropionate plus rescue salbutamol significantly increased the percentage of symptom-free days (primary endpoint, defined as a lack of wheezing, coughing, shortness of breath and patients/parents nocturnal awakenings in 24 h) (69.6 ± 20.89 [SD]; P = 0.034) vs placebo/rescue salbutamol (61.0 ± 24.83 [SD]) but not vs combination nebulised beclometasone dipropionate /rescue salbutamol (64.9 ± 24.74 [SD]) regardless of the presence of risk factors for developing asthma.
Maltese: Jistgħu jseħħu effetti sistemiċi ta' kortikosterojdi meħuda man-nifs (eż. beclometasone dipropionate) speċjalment meta jingħataw b'dożi għoljin preskritti għal perjodi twal, dawn jistgħu jinkludu soppressjoni adrenali, tnaqqis fid-densità minerali tal-għadam, ittardjar tat-tkabbir fi tfal u adolexxenti,
English: Preclinical toxic effects of beclometasone dipropionate were confined to those associated with overstimulation of the recognised pharmacological action.
Maltese: Effetti tossiċi ta' qabel l-użu kliniku ta' beclometasone dipropionate kienu limitati għal dawk assoċjati ma' stimulazzjoni żejda tal-azzjoni farmakoloġika rikonoxxuta.
English: The systemic pharmacodynamic effects of beclometasone dipropionate and its active metabolite B17MP is assessed by measuring the effects on hypothalamopituitary adrenal (HPA)-axis function.
Maltese: B17MP huma evalwati billi jitkejjlu l-effetti fuq il-funzjoni tal-assi tal-ipotalamu-pitwitarja-adrenali (HPA - hypothalamic-pituitary-adrenal).
English: The unit dose ampoule should be used according to the following instructions:
Maltese: Id-dożi tal-bidu rakkomandati huma:
English: • an allergic reaction (swelling of the eyes, face, lips and throat leading to severe difficulty in breathing, skin rashes, hives, itching or redness)
Maltese: • reazzjoni allerġika (nefħa tal-għajnejn, wiċċ, xufftejn u griżmejn li twassal għal diffikultà severa biex tieħu n-nifs, raxx tal-ġilda, ħorriqija, ħakk jew ħmura)
English: via a nebulizer.
Maltese: TA' EĊĊIPJENTI
English: Normally, a daily dose of 3200 micrograms in adults and adolescents and 1600 micrograms in children up to 11 years of age should not be exceeded.
Maltese: kuljum ta' 1600 mikrogramma fit-tfal u 3200 mikrogramma fl-adulti.