natgillin/translations-raw huggingface dataset:
Partially used multidose vials must be kept between 2°C and 8°C (i.e., in a refrigerator) and protected from light.
Delno uporabljene viale z več odmerki je treba shranjevati na temperaturi od 2 do 8 °C (tj. v hladilniku) in zaščitene pred svetlobo.
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.
Vendar je bila ocenjena ekstrapolirana učinkovitost cepiva (1 - razmerje ogroženosti) na podlagi eksplorativne analize (združene študije CYD14 + CYD15 + CYD23) med 25-mesečnim obdobjem po prvi injekciji 89,2 % (95 % IZ: 78,5; 94,6) za hospitalizirane primere VPD in 95,3 % (95 % IZ: 68,9; 99,3) za hude primere VPD.
3.2 Immunogenicity data for subjects 18 to 45 years of age in endemic areas
Podatki o imunogenosti pri osebah v starosti od 18 do 45 let na endemičnih območjih
PHARMACEUTICAL FORM AND CONTENTS Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe with 2 separate needles Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe Pack size of 1 or 10
FARMACEVTSKA OBLIKA IN VSEBINA Prašek (1 odmerek) in viali + 0,5 ml vehikla v napolnjeni injekcijski brizgi z dvema ločenima iglama Prašek (1 odmerek) in viali + 0,5 ml vehikla v napolnjeni injekcijski brizgi
CYD14 485 CYD15 1048
CYD14 485 167
VE is calculated using density incidence (cases per 100 person-years at risk) * Pooled results of CYD14, 15 and 23 need to be interpreted cautiously because of differences in the Dengue confirmatory test and acute febrile illness definition between CYD14/15 and CYD23.
UC je izračunana glede na pogostost incidence (primerov na 100 oseb - izpostavljenost v letih) * Združene (kumulativne) rezultate študij CYD14, CYD15 in CYD23 je treba tolmačiti previdno, ker so med CYD14/15 in CYD23 obstajale razlike v potrditvenem testu za dengo in v opredelitvi akutne febrilne bolezni.
Dengvaxia is provided as a powder in a 5-dose vial and a solvent in a 5-dose vial (2.5 mL).
Cepivo Dengvaxia je na voljo kot prašek v viali s 5 odmerki in vehikel v viali s 5 odmerki (2,5 ml).
*Pooled results of CYD14, 15 and 23 need to be interpreted cautiously because of differences in the Dengue confirmatory test and acute febrile illness definition between CYD14/15 and CYD23.
*Združene (kumulativne) rezultate študij CYD14, CYD15 in CYD23 je treba tolmačiti previdno, ker so med CYD14/15 in CYD23 obstajale razlike v potrditvenem testu za dengo in v opredelitvi akutne febrilne bolezni.
STATEMENT OF ACTIVE SUBSTANCES After reconstitution, one dose (0.5 mL) contains 4.5 - 6.0 log10 CCID50 of each serotype of the chimeric yellow fever dengue virus (1, 2, 3 and 4) (live, attenuated).
Po rekonstituciji vsebuje en odmerek (0,5 ml) 4,5-6,0 log10 CCID50 vsakega serotipa himernega virusa rumene mrzlice denge (1, 2, 3 in 4) (živo, oslabljeno).
What Dengvaxia looks like and contents of the pack Dengvaxia is a powder and solvent for suspension for injection.
Cepivo Dengvaxia je prašek in vehikel za suspenzijo za injiciranje.
What is dengue and dengue disease?
Kaj je vročica denga?
Oropharyngeal pain Cough
Orofaringealna bolečina Kašelj
What Dengvaxia contains
Kaj vsebuje cepivo Dengvaxia
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 Dose
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek
Dengvaxia must not be administered by intravascular injection under any circumstances.
Cepiva Dengvaxia se ne sme v nobenem primeru injicirati intravaskularno.
VE % (95%CI)
UC (%) (95 % IZ)
2.2 Clinical efficacy data for subjects 9 to 16 years of age in endemic areas, dengue seropositive at baseline
2.2 Podatki o klinični učinkovitosti pri preiskovancih, starih od 9 do 16 let na endemičnih območjih, ki so bili izhodiščno seropozitivni za dengo
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.
Pri osebah v starosti od 9 do 16 let, izhodiščno seropozitivnih za dengo (podskupina za imunogenost), so med 25-mesečnih obdobjem po prvi injekciji v vsaki posamezni študiji (CYD14 in CYD15) zabeležili en klinično hud primer VPD in en primer VPD po SZO HMD v kontrolni skupini; v cepljeni skupini takšnih primerov niso zabeležili.
In an exploratory analysis of the long-term follow up from the first injection in three efficacy studies, an increased risk of hospitalisation for dengue including clinically severe dengue (predominantly Dengue Haemorrhagic Fever grade 1 or 2 [WHO 1997]) has been observed in vaccinees with no previous dengue infection.
V treh študijah učinkovitosti so v eksplorativni analizi dolgoročnega spremljanja po prvi injekciji pri cepljenih osebah, ki predhodno niso bile okužene z dengo, opažali večje tveganje za sprejem v bolnišnico zaradi denge, vključno s klinično hudo obliko denge (pretežno hemoragična vročica denga 1. ali 2. stopnje [SZO 1997]).
In vaccinees 2 to 8 years of age with no previous dengue infection, long-term safety follow-up data showed an increased risk of dengue disease requiring hospitalisation including clinically severe dengue.
Dolgoročno spremljanje varnosti je pri cepljenih otrocih, starih od 2 do 8 let, ki predhodno niso bili okuženi z dengo, pokazalo večje tveganje za obliko denge, ki zahteva sprejem v bolnišnico, vključno s klinično hudo obliko denge.
During a period of 6 years after the first injection, in subjects 9 years of age and above with previous dengue infection, the extrapolated vaccine efficacy (1-Hazard Ratio)*100 (obtained from an exploratory analysis) is estimated at 80 (95% CI: 69; 87) for hospitalized VCD and 84 (95% CI: 61; 94) for severe VCD.
Med 6-letnim obdobjem po prvi injekciji je bila ocenjena ekstrapolirana učinkovitost cepiva (1razmerje ogroženosti)*100 (na podlagi eksplorativne analize) pri osebah, starih 9 let ali več in predhodno okuženih z dengo, 80 (95 % IZ: 69; 87) za hospitalizirane primere VPD in 84 (95 % IZ: 61; 94) za hude primere VPD.
Reconstitute Dengvaxia with the solvent provided.
Cepivo Dengvaxia rekonstituirajte s priloženim vehiklom.
Powder and solvent for suspension for injection Prior to reconstitution, the vaccine is a white, homogenous, freeze-dried powder with possible retraction at the base (ring-shaped cake possible).
Pred rekonstitucijo je cepivo bel, homogen, liofiliziran prašek z možnim sprimkom na spodnji strani (lahko v obliki obročaste pogače).
Uncommon: (may affect up to 1 in 100 people)
Občasni: (pojavijo se lahko pri največ 1 od 100 oseb)
• injection site warmth
• toplota na mestu injiciranja
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.