FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients receiving treatment with immunoglobulins or blood products containing immunoglobulins, such as blood or plasma, it is recommended to wait for at least 6 weeks, and preferably for 3 months, following the end of treatment before administering Dengvaxia, in order to avoid neutralization of the attenuated viruses contained in the vaccine.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Għal pazjenti li jirċievu kura b'immunoglobini jew prodotti tad-demm li fihom immunoglobini, bħal demm jew plażma, hija rakkomandata stennija għal tal-inqas 6 ġimgħat, u preferibbilment għal 3 xhur, wara tmiem il-kura qabel jingħata Dengvaxia, sabiex tiġi evitata newtralizzazzjoni tal-virusis attenwati fil-vaċċin.
English: However, the extrapolated vaccine efficacy (1- Hazard Ratio), obtained from an exploratory analysis (pooled CYD14 + CYD15 + CYD23) over 25-month period after the first injection, is estimated at 89.2% (95% CI: 78.5; 94.6) for hospitalized VCD and 95.3% (95% CI: 68.9; 99.3) for severe VCD.
Maltese: Madankollu, l-effikaċja tal-vaċċin estrapolat (1- Proporzjon ta' Periklu), miksuba minn analiżi esploratorja (CYD14 + CYD15 + CYD23 miġbura) fuq perjodu ta' 25 xahar wara lewwel injezzjoni, huwa stmat għal 89.2% (95% CI: 78.5; 94.6) għal VCD li jkun jeħtieġ dħul fl-isptar u 95.
English: N=4972 N=20854
Maltese: CYD14 VE % (95% CI) N=4,972
English: This phase includes therefore the primary endpoint observation period from 28 days after the third injection up to the end of the Active Phase.
Maltese: Għalhekk, din il-fażi tinkludi lperjodu ta' osservazzjoni tal-end-point primarju minn 28 jum wara t-tielet injezzjoni sal-aħħar tal-Fażi Attiva.
English: The Vaccine Efficacy (VE) results according to the primary endpoint (symptomatic VCD cases occurring during the 12-month period starting from 28 days after the third injection) in subjects 9 to 16 years of age (any serostatus at baseline) are shown in Table 3 for studies CYD14, CYD15 and CYD23.
Maltese: Ir-riżultati tal-Effikaċja tal-Vaċċin (Vaccine Efficacy, VE) skont l-end-point primarju (każijiet ta' VCD sintomatika li seħħew waqt il-perjodu ta' 12-il xahar li beda 28 jum wara t-tielet injezzjoni) f'individwi ta' età ta' 9 sa 16-il sena (kwalunkwe serostatus fil-linja bażi) jidhru f'Tabella 3 għallistudji CYD14, CYD15 u CYD23.
English: Higher titres post-injection 3 are associated with a lower risk of dengue disease and higher vaccine efficacy, although an immunological correlate of protection has not been established.
Maltese: Titers ogħla wara injezzjoni 3 huma assoċjati ma' riskju aktar baxx ta' marda ta' dengue u effikaċja ogħla tal-vaċċin, għalkemm ma ġiex stabbilit korrelat immunoloġiku ta' protezzjoni.
English: The GMTs levels depend on age and dengue serostatus at baseline.
Maltese: Illivelli ta' GMT jiddependu mill-età u mis-serostatus ta' dengue fil-linja bażi.
English: Dengue is not transmitted directly from personto-person.
Maltese: Dengue ma tiġix trażmessa direttament minn persuna għal persuna.
English: Also, considering that Dengvaxia is a live attenuated vaccine and that there is very limited experience from post marketing data with Dengvaxia in lactating women, the vaccine is contraindicated during lactation (see section 4.3).
Maltese: Barra minn hekk, meta jitqies li Dengvaxia huwa vaċċin attenwat ħaj u li hemm esperjenza limitata ħafna minn dejta ta' wara t-tqegħid fis-suq b'Dengvaxia f'nisa li jkunu qed ireddgħu, il-vaċċin m'għandux jingħata waqt it-treddigħ (ara sezzjoni 4.3).
English: 2.1 Clinical efficacy data for subjects 9 to 16 years of age in endemic areas, any serostatus at baseline
Maltese: 2.1. Dejta dwar l-effikaċja klinika għal individwi ta' età ta' 9 sa 16-il sena f'żoni endemiċi, kwalunkwe serostatus fil-linja bażi
English: • infections of the nose or throat (upper respiratory tract)
Maltese: • infezzjonijiet tal-imnieħer jew tal-griżmejn (apparat respiratorju ta' fuq)
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: For instructions on reconstitution of Dengvaxia before administration, see section 6.6.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni ta' Dengvaxia, ara sezzjoni 6.3.
English: The following side effects occurred during studies in children, young people and adults.
Maltese: L-effetti sekondarji li ġejjin seħħew waqt studji fi tfal, żgħażagħ u adulti.
English: Sanofi-Aventis Estonia OÜ Tel.: +372 627 3488
Maltese: Latvia SIA Vakcīnu nodaļa Tel.: +371 67114978
English: After reconstitution with the solvent provided, Dengvaxia is a clear, colourless liquid with the possible presence of white to translucent particles.
Maltese: Wara rikostituzzjoni bis-solvent ipprovdut, Dengvaxia huwa likwidu ċar, bla kulur bil-preżenza possibbli ta' partikuli bojod għal trasluċenti.
English: In the following Tables the dengue serostatus at baseline (before the first injection), was defined as:
Maltese: Fit-Tabelli li ġejjin, is-serostatus ta' dengue fil-linja bażi (qabel l-ewwel injezzjoni), ġie definit bħala:
English: Partially used multidose vials must be kept between 2°C and 8°C (i.e., in a refrigerator) and protected from light.
Maltese: Kunjetti li jkunu intużaw parzjalment għandhom jinżammu bejn 2°C u 8°C (jiġifieri, fi friġġ) u jiġu protetti mid-dawl.
English: The efficacy was assessed during an Active Phase of 25 months, in which surveillance was designed to maximize the detection of all symptomatic virologically-confirmed dengue (VCD) cases regardless of the severity.
Maltese: L-effikaċja ġiet ivvalutata waqt Fażi Attiva ta' 25 xahar, li fiha, is-sorveljanza ġiet imfassla biex timmassimizza l-identifikazzjoni tal-każijet kollha ta' dengue kkonfermata viroloġikament (virologically-confirmed dengue, VCD) sintomatika irrispettivament mis-severità.
English: N: number of subjects per study
Maltese: N: numru ta' individwi għal kull studju
English: • Powder (1 dose) in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene) + 0.5 mL of solvent in a pre-filled syringe (Type-I glass), with a plunger stopper (halobutyl) and a tip cap (elastomer) with 2 separate needles.
Maltese: polypropylene) + 0.5 ml ta' solvent f'siringa mimlija għal-lest (ħġieġ tat-Tip I), b'tapp tal planġer (halobutyl) u tapp tat-tarf (elastomer) b'2 labriet separati.
English: • injection site reactions: redness (erythema), bruising (haematoma), swelling, and itching
Maltese: • reazzjonijiet fis-sit tal-injezzjoni: ħmura (eritema), tbenġil (ematoma), nefħa u ħakk (pruritu).
English: NaCl (0.4%)
Maltese: Solvent għr-rikostituzzjoni ta' Dengvaxia NaCl (0.4%)
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA ATTIVA(I)
English: 3.2 Immunogenicity data for subjects 18 to 45 years of age in endemic areas
Maltese: Dejta dwar l-immunoġeniċità għal individwi ta' età ta' 18 sa 45 sena f'żoni endemiċi
English: Dengvaxia contains live attenuated viruses.
Maltese: Dengvaxia fih virusis attenwati ħajjin.
English: Travellers
Maltese: Organi
English: In subjects 9 through 16 years of age dengue seropositive at baseline (immunogenicity subset), one clinically severe VCD case and one WHO DHF VCD case was reported during the 25-month period after the first injection in the control group in each individual study (CYD14 and CYD15) versus none in the vaccine group.
Maltese: każ VCD klinikament severa u każ wieħed tad-WHO DHF VCD kien irrappurtat matul il-Perjodu ta' 25 xahar wara l-ewwel injezzjoni fil-grupp ta' kontroll f'kull studju individwali (CYD14 u CYD15)
English: Injection site reactions (hematoma, pruritus) Injection site induration
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (ematoma, pruritu)
English: • injection site warmth
Maltese: GMT wara injezzjo ni 3
English: Vaccination should be preceded by a review of the individual's medical history (in particular, previous vaccinations and possible adverse reactions which occurred after vaccination).
Maltese: It-tilqim għandu jiġi preċedit minn rieżami tal-istorja medika tal-individwu (b'mod partikolari, tilqim preċedenti u reazzjonijiet avversi possibbli li seħħew wara t-tilqim).
English: Or
Maltese: CI)
English: Subcutaneous use after reconstitution.
Maltese: f'reġjuni mhux endemiċi.
English: It is used to help protect you or your child against "dengue disease" caused by dengue virus serotypes 1, 2, 3 and 4.
Maltese: Dan jintuża biex jgħin jipproteġi lilek jew lill-wild tiegħek kontra “marda ta' dengue” ikkawżata minn serotipi 1, 2, 3 u 4 tal-virus dengue.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskji tiġi modifikata speċjalment bħala riżultat ta' informazzjoni ġdida riċevuta li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew għaliex jintlaħaq stadju importanti (farmakoviġilanza jew minimizzazzjoni tar riskji).
English: • Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or after prior administration of Dengvaxia or a vaccine containing the same components.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1, jew qabel l-għoti ta' Dengvaxia jew vaċċin li jkun fih l-istess komponenti.
English: 4 serotypes.
Maltese: Kwalunkwe serotip
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: Dħul fl-Isptar†
English: • are of child-bearing age, you must use an effective method of contraception to avoid pregnancy for at least one month after each Dengvaxia dose.
Maltese: • qegħdin f'età li jista' jkollkom t-tfal, għandkom tużaw metodu effettiv ta' kontraċezzjoni sabiex tevitaw tqala għal tal-inqas xahar wara kull doża ta' Dengvaxia.
English: • Powder (1 dose) in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene) + 0.5 mL of solvent in pre-filled syringe (Type-I glass), with a plunger stopper (halobutyl) and a tip cap (elastomer).
Maltese: polypropylene) + 0.5 ml ta' solvent f'siringa mimlija għal-lest (ħġieġ tat-Tip I), b'tapp tal planġer (halobutyl) u tapp tat-tarf (elastomer).
English: NaCl (0.9%)
Maltese: Solvent għr-rikostituzzjoni ta' Dengvaxia NaCl (0.9%)
English: 2.4 Other paediatric data from efficacy studies in subjects 2 through 8 years of age, i.e., outside the age indication
Maltese: Dejta pedjatriku oħra minn studji ta' effikaċja f'individwi minn 2 sa 8 snin, jiġifieri, barra l indikazzjoni tal-età
English: Available from: http://www.ginasthma.org/ .
Maltese: Disponibbli minn: http://www.ginasthma.org/ .
English: Beclometasone dipropionate (BDP) is a glucocorticoid and a prodrug of the active metabolite, beclometasone-17-monopropionate.
Maltese: Beclometasone dipropionate (BDP) huwa glukokortikojde u promediċina tal-metabolit attiv, beclometasone-17-monopropionate.
English: The cumulative prevalence of wheeze is almost 50% at the age of 6 years.
Maltese: Il-prevalenza kumulattiva tat-tħarħir hija kważi 50% fl-età ta' 6 snin.
English: Profita M. et al ‘ Effect of Nebulized Beclomethasone on Airway Inflammation and Clinical Status of Children with Allergic Asthma and Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Study'.
Maltese: 3 Profita M. et al ‘ Effect of Nebulized Beclomethasone on Airway Inflammation and Clinical Status of Children with Allergic Asthma and Rhinitis:
English: Finally, recent evidence reports that distribution of topical solution to the unoperated sinuses is limited, with nebulization being also ineffective with <3% sinus penetration.
Maltese: Finalment, evidenza riċenti tirrapporta li d-distribuzzjoni ta' soluzzjoni topika għas-sinusijiet mhux operati hija limitata, bin-nebulizzazzjoni tkun ineffettiva wkoll b'<3% penetrazzjoni tas-sinus.
English: Paediatric age range
Maltese: Firxa tal-età pedjatrika
English: Section 1, (name of the medicial product) Sections 2 (qualitative and quantitative composition), 6.1 (list of excipients), and 6.2 (incompatibilities) have been updated with minor changes to be in line with QRD template.
Maltese: Sezzjoni 1, (isem tal-prodott mediċinali), Sezzjonijiet 2 (għamla kwalitattiva u kwantitattiva), 6.1 (lista ta' eċċipjenti), u 6.2 (inkompatibbiltajiet) ġew aġġornati b'tibdil żgħir sabiex ikunu konformi mal mudell tal-QRD.
English: Sections 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) have been updated in line with the recommendation for multi-use of the 800 ug ampoule.
Maltese: Sezzjonijiet 6.3 (żmien kemm idum tajjeb il-prodott mediċinali), 6.4 (prekawzjonijiet speċjali għallħażna) 6.5 (in-natura tal-kontenitur u ta' dak li hemm ġo fih) u 6.6 (Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor) ġew aġġornati sabiex ikunu konformi mar-rakkomandazzjoni għall-użu multiplu tal-ampulla ta' 800 ug.
English: 1 GINA: From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2015.
Maltese: Mill-Istrateġija Globali għall-Ġestjoni u l-Prevenzjoni tal-Ażma, Inizjattiva Globali għall-Ażma (Global Initiative for Asthma
English: In fact, pharmaceutical formulations for nebulization are intended for asthma treatment as they deliver particles with particle size distribution less than 5 microns that can reach lower airways using facial masks; the fact that a nebuliser suspension administered through the facial mask is not suitable for administration to the nasal cavity is also proven by the cited article by Profita and colleagues where no differences were observed between the nBDP provided by facial mask and the placebo group for symptom score of rhinitis.
Maltese: Fil-fatt, formulazzjonijiet farmaċewtiċi għan-nebulizzazzjoni huma intiżi għall-kura tal-ażma minħabba li dawn iwasslu frak b'distribuzzjoni tad-daqs tal-frak ta' anqas minn 5 microns li jistgħu jilħqu passaġġi tal-arja aktar baxxi bl-użu ta' maskri tal-wiċċ; il-fatt li sospensjoni tan-nebulizzatur mogħtija minn ġo maskra tal-wiċċ mhijiex adegwata għall-għoti fil-kavità nażali hija mixhuda wkoll mill-artikolu ċitat minn Profita u kollegi fejn ma ġewx osservati differenzi bejn l-nBDP ipprovdut mill-maskra tal-wiċċ u l-grupp tal-plaċebo għall-punteġġ tas-sintomu tar-rinite.
English: On review of all available data including post marketing safety data the CHMP concluded that a maximum of 3200 ug daily dose of BDP in adults and adolescents, which is in line with the current recommendation in Germany, Ireland and Greece and of a maximum of 1600 ug daily dose in children, which is in line with the current recommendation in France, is acceptable.
Maltese: ikkonkluda li doża massima ta' kuljum ta' 3200 ug ta' BDP fl-adulti u fl-adolexxenti, li hija konformi mar-rakkomandazzjoni attwali fil-Ġermanja, fl-Irlanda u fil-Greċja u ta' doża massima ta' kuljum ta' 1600 ug fit-tfal, li hija konformi mar-rakkomandazzjoni attwali fi Franza, hija aċċettabbli.
English: The evidence provided by the MAH in support of this indication consisted of 4 studies, only one of which is a randomised clinical trial (Profita et al., 2013)3.
Maltese: L-evidenza pprovduta mill-MAH f'appoġġ ta' din l-indikazzjoni kkonsistiet minn 4 studji, fejn wieħed minnhom biss huwa prova klinika randomizzata (Profita et al., 2013)3.
English: 4 Allergic Rhinitis and its Impact on Asthma (ARIA) guideline 2015: Available from http://www.whiar.org/Documents&Resources.php
Maltese: Allergic Rhinitis and its Impact on Asthma (ARIA) guideline 2015:
English: The MAH proposed to revise the SmPC section 4.2 to include more detailed information on the nebuliser systems.
Maltese: Il-MAH ippropona li jirrevedi sezzjoni 4.2 tal-SmPC sabiex jinkludi aktar informazzjoni dettaljata fuq is-sistemi tan-nebulizzatur.
English: BDP nebuliser (nBDP) suspension products are authorised in five EU member states including France, Germany, Greece, Ireland and Italy under different invented names: Sanasthmax, Becloneb, Beclospin, Clenil.
Maltese: Il-prodotti ta' sospensjoni tal-nebulizzatur BDP (nBDP) huma awtorizzati f'ħames Stati Membri tal-UE inkluż Franza, il-Ġermanja, il-Greċja, l-Irlanda u l-Italja taħt ismijiet ivvintati differenti:
English: Section 4.2 - Posology and method of administration Maximum daily dose
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata Doża massima ta' kuljum
English: Sections 4.3 Contraindications to 5.3 Preclinical safety data have been harmonised to include the relevant available information, or amend wording according to the attest QRD template.
Maltese: Sezzjonijiet 4.3 Kontraindikazzjonijiet sa 5.3 Data ta' qabel l-użu kliniku dwar is-sigurtà ġew armonizzati sabiex jinkludu l-informazzjoni disponibbli relevanti, jew sabiex jemendaw il-kliem skont il-mudell tal-QRD attestat.
English: The evidence and argumentation provided by the MAH on the beneficial effect of nBDP in the treatment of the broad proposed indications (bronchostenotic condition as initial one, inflammatory disorders of the respiratory tract in particular associated with wheezing as second one) was considered by the CHMP unsatisfactory in identifying the medical need and the target population (lack of adequately designed and sized trials).
Maltese: dwar l-effett ta' benefiċċju ta' nBDP fil-kura tal-indikazzjonijiet proposti wiesgħin (kundizzjoni brokostenotika bħala l-ewwel waħda, disturbi infjammatorji tas-sistema respiratorja b'mod partikolari assoċjati mat-tħarħir bħala t-tieni) ma tqisux sodisfaċenti mis-CHMP fl-identifikazzjoni tal-ħtieġa medika u l-popolazzjoni fil-mira (nuqqas ta' provi mfassla b'mod adegwat u mdaqqsa).
English: The most supportive evidence for the treatment of recurrent wheezing children (Papi et al., 2009)2 enrolled children aged 1-4 years.
Maltese: L-evidenza l-aktar ta' appoġġ għall-kura ta' tfal bi tħarħir rikorrenti (Papi et al., 2009)2 irreġistrat tfal bejn l-etajiet ta' sena u 4 snin.
English: In conclusion, the CHMP considered that the available evidence does not support the proposed indications in "allergic and idiopathic rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhino-pharyngeal tract" for nBDP.
Maltese: Bħala konklużjoni, is-CHMP ikkunsidra li l-evidenza disponibbli ma tappoġġjax l-indikazzjonijiet proposti b'"rinite allerġika u idjopatika, affezzjonijiet infjammatorji u allerġiċi tal-kavitajiet nażali u tas-sistema rino-farinġeali" għal nBDP.
English: However, the study referred to enrolled 5 healthy adults, which is not a representative sample.
Maltese: Madankollu, l-istudju rrefera għal 5 adulti b'saħħithom irreġistrati, li mhuwiex kampjun rappreżentattiv.
English: Cross-reference with section 4.4 is also mentioned.
Maltese: Referenza mqabbla ma' sezzjoni 4.4
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and in line with GINA guidelines.
Maltese: Il-MAH ippropona rakkomandazzjonijiet tad-dożaġġ armonizzati abbażi tad-dożi studjati fi provi kliniċi u skont il-linji gwida GINA.
English: In France nBDP is indicated as anti-inflammatory treatment of severe persistent asthma in children.
Maltese: Fi Franza nBDP huwa indikat bħala kura kontra l-infjammazzjonijiet ta' ażma severa persistenti fit tfal.
English: Asthma and wheezing
Maltese: hija msemmija wkoll.
English: Allergic and idiopathic rhinitis, inflammatory and allergic affections of the nasal cavities and of the rhinopharyngeal tract
Maltese: Rinite allerġika u idjopatika, affezzjonijiet infjammatorji u allerġiċi tal-kavitajiet nażali u tas-sistema rino-farinġeali
English: It is acknowledged that the scientific evidence on the benefit of nBDP in the treatment of recurrent wheezing in pre-schooler is limited (the only supportive scientific evidence comes from Papi and colleagues (2009) in which methodological bias is noted); however, high standard studies, as per today criteria, are not expected to be available for nBDP to support indication that has been granted in Italy many years ago.
Maltese: Huwa magħruf li l-evidenza xjentifika dwar il-benefiċċju ta' nBDP fil-kura tat-tħarħir rikorrenti fi tfal ta' qabel l-età tal-iskola hija limitata (l-unika evidenza xjentifika ta' appoġġ ġejja minn Papi u kollegi (2009) fejn ġie nnutat preġudizzju metodoloġiku); madankollu, studji ta' standard għoli, skont ilkriterji tal-lum, mhumiex mistennija li jkunu disponibbli għall-nBDP sabiex jappoġġjaw l-indikazzjoni li ngħatat fl-Italja ħafna snin ilu.
English: Clenil is currently indicated for the treatment of other respiratory conditions with the narrowing of the airways in the lungs (bronchostenotic condition) in Italy.
Maltese: Bħalissa Clenil huwa indikat għall-kura ta' kundizzjonijiet respiratorji oħrajn bit-tidjiq tal-passaġġi tal arja fil-pulmun (kundizzjoni brokostenotika) fl-Italja.
English: Taking into account the available data and guidelines the CHMP agreed that there should not be a lower age limit recognising that there is a possible need of beclometasone below 6 months of age.
Maltese: Filwaqt li kkunsidra d-data u l-linji gwida disponibbli, is-CHMP qabel li m'għandux ikun hemm limitu tal-età aktar baxx, fejn jirrikonoxxi li hemm il-ħtieġa possibbli ta' beclometasone taħt l-età ta' 6 xhur.
English: As such reference is not made to a brand rather to a “jet nebuliser” in the product information.
Maltese: Għaldaqstant ma ssirx referenza għal ditta, minflok għal "nebulizzatur ġett" fl-informazzjoni dwar il prodott.
English: Int Arch Allergy Immunol
Maltese: Sezzjonijiet oħrajn tal-SmPC
English: • The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Maltese: • Il-kumitat irreveda t-totalità tad-data ppreżentata mill-MAH b'appoġġ għall-armonizzazzjoni proposta tal-informazzjoni dwar il-prodott.
English: In GINA guideline, low dose ICS (controller treatment) is recommended as the preferred initial treatment to control asthma in children 5 years and younger.
Maltese: Fil-linja gwida GINA, ICS (kura ta' kontroll) ta' doża baxxa hija rrakkomandata bħala l-kura inizjali ppreferuta sabiex tikkontrolla l-ażma fi tfal ta' 5 snin u iżgħar.
English: Beclometasone dipropionate exerts local anti-inflammatory action in the control of bronchial asthma.
Maltese: Bħalissa beclomethasone dipropionate huwa indikat fit-tfal fl-Istati Membri tal-UE kollha fejn il prodott huwa awtorizzat.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of nBDPcontaining products, Italy notified the CHMP/European Medicines Agency on 19 June 2015 of a referral under Article 30 of Directive 2001/83/EC for Clenil and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise its divergent product information across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri fir-rigward tal awtorizzazzjoni ta' prodotti li fihom nBDP, fid-19 ta' Ġunju 2015, l-Italja nnotifikat lis
English: In Ireland, Germany and Greece nBDP is indicated in both adults and children for the treatment of bronchial asthma where use of a pressurised or dry powder inhaler is unsatisfactory or inappropriate.
Maltese: Fl-Irlanda, fil-Ġermanja u fil-Greċja nBDP huwa indikat kemm fl-adulti kif ukoll fit-tfal għall-kura ta' ażma fil-bronki fejn l-użu ta' inalaturi taħt pressjoni jew bi trab xott mhuwiex sodisfaċenti jew mhuwiex xieraq.