natgillin/translations-raw huggingface dataset:
Table 4: VE against symptomatic, Hospitalised or Severe VCD over the 25-month period after the first injection in subjects 9 to 16 years of age (any serostatus at baseline) 
Preglednica 4: Učinkovitost cepiva proti simptomatskim, hospitaliziranim ali hudim primerom VPD v 25-mesečnem obdobju po prvi injekciji pri osebah v starosti od 9 do 16 let (ne glede na izhodiščno serološko stanje)
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja Občasni
It must not be injected into a blood vessel. 
Cepiva se ne sme injicirati v žilo.
In this case, your doctor will not use Dengvaxia until 6 weeks, and preferably not for 3 months after you stop treatment. 
V tem primeru zdravnik ne bo uporabil cepiva Dengvaxia vsaj 6 tednov, po možnosti pa 3 mesece po koncu zdravljenja, kajti sicer cepivo Dengvaxia morda ne bi delovalo tako dobro.
Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe. 
Prašek (1 odmerek) in viali + 0,5 ml v napolnjeni injekcijski brizgi.
• Powder (5 doses) in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene) + 2.5 mL of solvent in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene). 
• Prašek (5 odmerkov) v viali (iz stekla tipa I) z zamaškom (halobutil) in snemno zaporko (aluminij, polipropilen) + 2,5 ml vehikla v viali (steklo tipa I) z zamaškom (halobutil) in snemno zaporko (aluminij, polipropilen).
Very common Injection site pain Malaise 
Bolečina na mestu injiciranja Splošno slabo počutje Astenija
1D 
1 O
Vaccine group 
Cepljena skupina
Injection site induration Injection site warmth Chills 
Zatrdlina na mestu injiciranja Toplota na mestu injiciranja Mrzlica
Table 5: VE against symptomatic VCD cases over the 12-month period starting from 28 days after the third injection due to any of the 4 serotypes in subjects 9 to 16 years (dengue seropositive at baseline). 
Preglednica 5: Učinkovitost cepiva proti simptomatskim primerom VPD v 12-mesečnem obdobju od 28 dni po tretji injekciji zaradi katerega koli od 4 serotipov pri preiskovancih, starih od 9 do 16 let (izhodiščno seropozitivnih za dengo)
Tell your doctor, pharmacist or nurse before using Dengvaxia if you or your child have: 
Preden dobite cepivo Dengvaxia, morate zdravnika, farmacevta ali medicinsko sestro obvestiti, če vi ali vaš otrok:
DHF meeting any WHO 
HMD, ki je izpolnjevala katero koli merilo SZO
Common: (may affect up to 1 in 10 people) 
Pogosti: (pojavijo se lahko pri največ 1 od 10 oseb)
Essential amino acids including Phenylalanine Non-essential amino acids Arginine hydrochloride Sucrose 
Prašek: esencialne aminokisline, vključno s fenilalaninom neesencialne aminokisline argininijev klorid saharoza trehaloza dihidrat sorbitol (E420) trometamol sečnina
Pooled * CYD14+CYD15+ CYD23 
Skupaj* CYD14 + CYD15 + CYD23
Table 3: VE against symptomatic VCD cases over the 12-month period starting from 28 days after the third injection due to any of the 4 serotypes in subjects 9 to 16 years (any serostatus at baseline). 
Preglednica 3: Učinkovitost cepiva proti simptomatskim primerom VPD v 12-mesečnem obdobju od 28 dni po tretji injekciji zaradi katerega koli od 4 serotipov pri preiskovancih v starosti od 9 do 16 let (ne glede na izhodiščno serološko stanje).
2.1 Clinical efficacy data for subjects 9 to 16 years of age in endemic areas, any serostatus at baseline 
2.1 Podatki o klinični učinkovitosti pri preiskovancih v starosti od 9 do 16 let na endemičnih območjih, ne glede na izhodiščno serološko stanje
Injection site reactions (erythema, swelling) 
Reakcije na mestu injiciranja (eritem, oteklina)
Injection site reactions (erythema, hematoma, swelling, pruritus) 
Zvišana telesna temperatura Reakcije na mestu injiciranja (eritem, hematom, oteklina, srbenje)
Trometamol 
serotipom
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Dengvaxia, powder for injection dengue tetravalent vaccine (live, attenuated) 
IME ZDRAVILA IN POT(I) UPORABE Dengvaxia prašek za injekcijo tetravalentno cepivo proti dengi (živo, oslabljeno) s.c.
How to store Dengvaxia 
Shranjevanje cepiva Dengvaxia
• 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. 
• Prašek (1 odmerek) v viali (iz stekla tipa I) z zamaškom (halobutil) in snemno zaporko (aluminij, polipropilen) + 0,5 ml vehikla v napolnjeni injekcijki brizgi (steklo tipa I) z zamaškom (halobutil) in zaporko konice (elastomer) z dvema ločenima iglama.
The Vaccine Efficacy (VE) results according to exploratory analysis of 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, seropositives at baseline are shown in Table 5 for the immunogenicity subset of studies CYD14, CYD15 and CYD23. 
Rezultati o učinkovitosti cepiva (UC) glede na raziskovalno analizo simptomatskih primerov VPD v 12-mesečnem obdobju od 28 dneva po tretji injekciji pri izhodiščno seropozitivnih preiskovancih, starih od 9 do 16 let, so glede na imunogensko podskupino v študijah CYD14, CYD15 in CYD23 prikazani v preglednici 5.
• 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). 
• Prašek (1 odmerek) v viali (iz stekla tipa I) z zamaškom (halobutil) in snemno zaporko (aluminij, polipropilen) + 0,5 ml vehikla v napolnjeni injekcijki brizgi (steklo tipa I) z zamaškom (halobutil) in zaporko konice (elastomer).
• fever. 
• mrzlica
In this case, your doctor will not use Dengvaxia until 4 weeks after you stop treatment. 
V tem primeru zdravnik ne bo uporabil cepiva Dengvaxia prej kot 4 tedne po koncu takšnega zdravljenja, kajti sicer cepivo Dengvaxia morda ne bi delovalo tako dobro.
Dengvaxia is reconstituted by transferring all of the solvent (0.9% sodium chloride solution) provided in the 5-dose vial with a dark gray flip-off cap into the 5-dose vial of freeze-dried powder with a medium brown flip-off cap, using a sterile syringe and needle. 
Za rekonstitucijo cepiva Dengvaxia je treba ves vehikel (0,9 % raztopino natrijevega klorida), ki se nahaja v viali s 5 odmerki s temnosivo snemno zaporko, prenesti v vialo s 5 odmerki liofiliziranega praška in rjavo snemno zaporko; za prenos je treba uporabiti sterilno brizgo in iglo.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 Doses 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 odmerkov
Dengvaxia is reconstituted by transferring all of the solvent (0.4% sodium chloride solution) provided in the blue-labelled pre-filled syringe into the vial of freeze-dried powder with a yellowish green flip-off cap. 
Za rekonstitucijo cepiva Dengvaxia je treba ves vehikel (0,4 % raztopina natrijevega klorida), ki se nahaja v modro označeni napolnjeni injekcijski brizgi, prenesti v vialo z liofiliziranim praškom in rumenkasto zeleno snemno zaporko.
Individuals who have not been previously infected by dengue virus or for whom this information is unknown should not be vaccinated because an increased risk of hospitalisation for dengue and clinically severe dengue (predominantly grade 1 or 2 Dengue Hemorrhagic Fever) has been observed in these individuals during the long-term follow up of clinical trials (see Section 4.8). 
Pri takšnih osebah so namreč med dolgoročnim spremljanjem v kliničnih preskušanjih opažali večje tveganje za sprejem v bolnišnico zaradi denge in za klinično hudo obliko denge (pretežno hemoragična vročica denga 1. ali 2. stopnje) (glejte poglavje 4.8).
Pooled CYD14+CYD15 
Skupaj CYD14+CYD15
The Vaccine Efficacy (VE) against symptomatic VCD, severe and hospitalised VCD during the 25month period after the first injection, which were secondary objectives, in subjects 9 to 16 years of age are shown in Table 4 for any serostatus at baseline for studies CYD14, CYD15 and CYD23. 
Učinkovitost cepiva (UC) proti simptomatski VPD, hudim primerom VPD in hospitalizacijam zaradi VPD med 25-mesečnim obdobjem po prvi injekciji (to so bili sekundarni opazovani dogodki) pri preiskovancih v starosti od 9 do 16 let v študijah CYD14, CYD15 in CYD23 so prikazani v preglednici 4 ne glede na izhodiščno serološko stanje.
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. 
Rezultati o učinkovitost cepiva (UC) glede na primarni opazovani dogodek (simptomatski primeri VPD v 12-mesečnem obdobju od 28 dneva po tretji injekciji) pri preiskovancih v starosti od 9 do 16 let (ne glede na izhodiščno serološko stanje) so za študije CYD14, CYD15 in CYD23 prikazani v preglednici 3.
Common 
Skupaj*
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Solvent in a pre-filled syringe (0.5 mL) 
Cepivo Dengvaxia - vehikel v napolnjeni injekcijski brizgi (0,5 ml)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe with 2 separate needles. 
Prašek (1 odmerek) in viali + 0,5 ml vehikla v napolnjeni injekcijski brizgi z dvema ločenima iglama.
Attach a sterile needle to the pre-filled syringe for the transfer of the solvent. 
Za prenos vehikla namestite sterilno iglo na napolnjeno injekcijsko brizgo.
Dengvaxia, powder and solvent for suspension for injection in multidose containers dengue tetravalent vaccine (live, attenuated) 
Dengvaxia prašek in vehikel za suspenzijo za injiciranje v večodmernih vsebnikih tetravalentno cepivo proti dengi (živo, oslabljeno)
LIST OF EXCIPIENTS 
Primerov/osebaleta
B. PACKAGE LEAFLET 
b. Seznam neželenih učinkov v preglednici
• sore throat (oropharyngeal pain) 
• vnetje žrela (orofaringealne bolečine)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for reconstitution of Dengvaxia 
IME ZDRAVILA IN POT(I) UPORABE Vehikel za rekonstitucijo cepiva Dengvaxia NaCl (0,9 %)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Solvent in vial (2.5 mL) 
Cepivo Dengvaxia - vehikel v viali (2,5 ml)
Outbreaks 
Izbruhi
Immunogenicity 
Omotica
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Powder (5 doses) in vial 
Cepivo Dengvaxia - prašek (5 odmerkov) v viali
Injection site reactions (hematoma, pruritus) Injection site induration 
Reakcije na mestu injiciranja (hematom, srbenje)
Dengvaxia, powder and solvent for suspension for injection in pre-filled syringe dengue tetravalent vaccine (live, attenuated) 
Dengvaxia prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi tetravalentno cepivo proti dengi (živo, oslabljeno)
Urea 
Navzea
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Powder (1 dose) in vial 
Cepivo Dengvaxia - prašek (1 odmerek) v viali
NAME OF THE MEDICINAL PRODUCT Dengvaxia, powder and solvent for suspension for injection in multidose containers dengue tetravalent vaccine (live, attenuated) 
Navodilo za uporabo Dengvaxia prašek in vehikel za suspenzijo za injiciranje v večodmernih vsebnikih tetravalentno cepivo proti dengi (živo, oslabljeno)
NAME OF THE MEDICINAL PRODUCT Dengvaxia, powder and solvent for suspension for injection in pre-filled syringe dengue tetravalent vaccine (live, attenuated) 
Navodilo za uporabo Dengvaxia prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi tetravalentno cepivo proti dengi (živo, oslabljeno)
Thus the proposed broad indications were considered unacceptable. 
Zato so bile predlagane splošne indikacije ocenjene kot nesprejemljive.
Cross-reference with section 4.4 is also mentioned. 
Omenjeno je tudi navzkrižno sklicevanje na poglavje 4.4.
However, the study referred to enrolled 5 healthy adults, which is not a representative sample. 
Vendar se je študija nanašala na 5 vključenih zdravih odraslih, kar pa ni reprezentativen vzorec.
Cain and colleagues.5 
Cain in sodelavci5.
This indication is not currently authorised in the other four EU member states (Greece, Germany, France and Ireland). 
Ta indikacija v ostalih štirih državah članicah EU (v Grčiji, Nemčiji, Franciji in na Irskem) trenutno ni odobrena.
Available from: http://www.ginasthma.org/ . 
Na voljo na spletnem mestu: http://www.ginasthma.org/.
This indication is currently only authorised in Italy, one out of the five EU member states where the product is licensed. 
Ta indikacija je trenutno odobrena le v Italiji, eni od petih držav članic EU, v katerih ima zdravilo dovoljenje za promet.
1 GINA: From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2015. 
1 GINA: iz svetovne strategije za vodenje in preprečevanje astme (Global Strategy for Asthma Management and Prevention), Svetovna pobuda za astmo (Global Initiative for Asthma - GINA), 2015.
As such recommendations regarding the duration treatment and the need of monitoring are included in sections 4.2 and 4.4 of the SmPC. 
Taka priporočila v zvezi s trajanjem zdravljenja in potrebo po spremljanju so vključena v poglavji 4.2 in 4.4 povzetka glavnih značilnosti zdravila.
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. 
Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z izdajo dovoljenja za promet z zdravili, ki vsebujejo nBDP, je Italija 19. junija 2015 obvestila odbor CHMP pri Evropski agenciji za zdravila o napotitvi v skladu s členom 30 Direktive 2001/83/ES za zdravilo Clenil in povezana imena z namenom odprave neskladij med nacionalno odobrenimi informacijami o zdravilu in uskladitve različnih informacij o zdravilu po vsej EU.
The paediatric population for which the product is approved is intended to be the overall paediatric population without excluding infants and toddlers. 
Predvideno je, da pediatrična populacija, za katero je zdravilo odobreno, vključuje splošno pediatrično populacijo, brez izključevanja dojenčkov in malčkov.
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. 
Zdravila v obliki suspenzije za nebulator BDP (nBDP) imajo dovoljenje za promet v petih državah članicah EU: v Franciji, Nemčiji, Grčiji, Italiji in na Irskem, in sicer pod različnimi izmišljenimi imeni: Sanasthmax, Becloneb, Beclospin in Clenil.
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. 
Ob upoštevanju razpoložljivih podatkov in smernic se je odbor CHMP strinjal, da spodnje starostne meje ne sme biti, s čimer je priznal morebitno potrebo po beklometazonu pri dojenčkih, mlajših od
Whereas 
Resist.
Due to the difficulty to set a lower age limit for the treatment of asthma/wheezing condition in the paediatric population, the CHMP considered more appropriate to leave it open. 
Ker je nižjo starostno mejo za zdravljenje astme/sopenja pri pediatrični populaciji težko postaviti, je odbor CHMP menil, da jo je bolje pustiti odprto.
Asthma and wheezing 
Astma in sopenje
Based on a review of the available data, the CHMP considered that both once daily and twice daily dose regimens are acceptable. 
Dajanje enkrat dnevno v primerjavi z dajanjem dvakrat dnevno Na podlagi pregleda razpoložljivih podatkov je odbor CHMP menil, da sta sprejemljiva oba režima odmerjanja, enkrat dnevno in dvakrat dnevno.
Section 4.2 - Posology and method of administration Maximum daily dose 
Poglavje 4.2 - Odmerjanje in način uporabe Največji dnevni odmerek
Overall, the CHMP agreed on the final indication wording "treatment of wheezing in children up to 5 years of age". 
Na splošno se je odbor CHMP strinjal s končnim besedilom za indikacijo, „zdravljenje sopenja pri otrocih, starih do 5 let“.
Most wheezing in preschool children (<5 years of age) is associated with viral upper respiratory tract infections, which recur frequently in this age group. 
Večina primerov sopenja pri predšolskih otrocih (< 5 let) je povezana z okužbami zgornjih dihal, ki se pri tej starostni skupini pogosto pojavljajo.
Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally. 
Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, kjer je bilo to ustrezno, vendar je bilo treba večino poglavij dopolniti na nacionalni ravni.
The studies in allergic rhinitis were actually carried out using intranasal spray. 
Študije alergijskega rinitisa so bile dejansko izvedene z uporabo intranazalnega pršila.
The CHMP also agreed that there is a need to give adequate information in the PI on the risk of long-term exposure in children below the age of 5 years. 
Odbor CHMP se je tudi strinjal, da je treba v informacijah o zdravilu podati zadostne informacije glede tveganja dolgotrajne izpostavljenosti otrok, mlajših od 5 let.
Beclomethasone dipropionate is currently indicated in children in all EU member states where the product is authorised. 
Beklometazon dipropionat je trenutno indiciran pri otrocih v vseh državah članicah EU, v katerih je zdravilo pridobilo dovoljenje za promet.
• The committee agreed on a harmonised product information for Clenil and associated names. 
• odbor se je strinjal z usklajenimi informacijami o zdravilu Clenil in povezanih imenih.
In the clinical managing of asthma, patient adherence to long-term inhaled therapy is of extreme importance and the possibility of a once daily administration should not be precluded. 
Pri kliničnem urejanju astme je bolnikovo sodelovanje pri dolgoročnem zdravljenju z inhalacijskimi zdravili izjemno pomembno in možnost dajanja enkrat dnevno ne sme biti onemogočena.
A confident diagnosis of asthma in children < 5 years of age is difficult, because episodic respiratory symptoms such as wheezing and cough are also common in children without asthma, particularly in those 0-2 years old. 
Postavljanje prepričljive diagnoze astme pri otrocih, starih < 5 let, je težavno, saj so občasni respiratorni simptomi, kot sta sopenje in kašelj, pogosti tudi pri otrocih brez astme, še posebno pri tistih, starih od nič do dve leti.
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. 
Priznava se, da so znanstveni dokazi o koristih zdravila nBDP pri zdravljenju ponavljajočega se sopenja pri predšolskih otrocih omejeni (edini podporni znanstveni dokazi prihajajo iz študije, ki so jo izvedli Papi in sodelavci (2009), v kateri pa je opažena metodološka pristranskost); vendar ni pričakovati, da bi bile za zdravilo nBDP na voljo študije, izvedene po visokih standardih v skladu z današnjimi merili, ki bi podpirale indikacijo, odobreno v Italiji pred mnogo leti.
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. 
Poglavja 6.3 (Rok uporabnosti), 6.4 (Posebna navodila za shranjevanje) 6.5 (Vrsta ovojnine in vsebina) in 6.6 (Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom) so posodobljena tako, da so v skladu s priporočili za uporabo 800-mikrogramske ampule na več načinov.
The most supportive evidence for the treatment of recurrent wheezing children (Papi et al., 2009)2 enrolled children aged 1-4 years. 
Dokazi, ki so najbolj podpirali zdravljenje ponavljajočega se sopenja pri otrocih (Papi idr., 2009)2, so bili pridobljeni pri otrocih, starih od enega do štirih let.
Clenil (and associated names) monodose was first approved through national procedure in Italy in 1991, then was approved through national procedures in France, while in Ireland, Germany and Greece through Mutual Recognition procedure with Ireland as Reference Member State. 
Zdravilo Clenil (in povezana imena) v enkratnem odmerku je dovoljenje za promet najprej pridobilo v Italiji leta 1991 po nacionalnem postopku, nato je po nacionalnih postopkih pridobilo dovoljenje za promet v Franciji, po postopku z medsebojnim priznavanjem pa je dovoljenje za promet pridobilo na Irskem, v Nemčiji in Grčiji, pri čemer je bila v vlogi referenčne države članice Irska.
The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and in line with GINA guidelines. 
Imetnik dovoljenja za promet z zdravilom je predlagal usklajena priporočila za odmerjanje na osnovi odmerkov, ki so jih preučevali v kliničnih preskušanjih, in v skladu s smernicami GINA.
Following the negative position of the CHMP on the broad indication, the MAH proposed a narrowed one "symptomatic treatment of recurrent wheezing in preschool children" that was agreed with some changes. 
Potem ko je odbor CHMP izrazil negativno stališče o splošnih indikacijah, je imetnik dovoljenja za promet z zdravilom predlagal ožjo indikacijo, tj. „simptomatsko zdravljenje ponavljajočega se sopenja pri predšolskih otrocih“, s katero se je odbor strinjal, a z nekaj spremembami.
This indication of the maintenance treatment of asthma when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate is currently approved in all five member states where the product is authorised. 
Indikacija za vzdrževalno zdravljenje astme, kadar je uporaba inhalatorjev pod tlakom ali s praškom nezadovoljiva ali neustrezna, je trenutno odobrena v vseh petih državah članicah, v katerih imajo zdravila dovoljenje za promet.
Beclometasone dipropionate (BDP) is a glucocorticoid and a prodrug of the active metabolite, beclometasone-17-monopropionate. 
Beklometazon dipropionat (BDP) je glukokortikoid in predzdravilo aktivnega presnovka, beklometazon-17-monopropionata.
• The committee considered the divergences identified in the notification for Clenil and associated names, as well as the remaining sections of the product information. 
• odbor je obravnaval razlike, prepoznane v obvestilu za zdravilo Clenil in povezana imena, ter preostala poglavja informacij o zdravilu;
Overall summary of the scientific evaluation by the CHMP 
Splošni povzetek znanstvenega vrednotenja odbora CHMP Vzdrževalno zdravljenje astme
The CHMP considered that the inclusion of the brand nebulisers in section SmPC 4.2 was not acceptable as the data to support this were not available. 
Odbor CHMP je menil, da vključitev nebulatorjev določene blagovne znamke v poglavje 4.2 povzetka glavnih značilnosti zdravila ni sprejemljiva, saj podatki, ki bi to podpirali, niso na voljo.
Pre-schoolers with recurrent wheezing are at high risk of developing asthma during school age; in this population asthma and wheezing do not always overlap and deciding when recurrent wheezing is the initial presentation of asthma is difficult. 
Pri predšolskih otrocih s ponavljajočim se sopenjem obstaja visoko tveganje za razvoj astme v šolskem obdobju; v tej populaciji se astma in sopenje ne prekrivata vedno, odločanje o tem, ali je ponavljajoče se sopenje začetek astme, pa je težavno.