natgillin/translations-raw huggingface dataset:
No robust study was conducted for Polyvaccinum and no data in adults was identified.
Z zdravilom Polyvaccinum ni bila opravljena nobena zanesljiva študija in podatkov za odrasle niso našli.
Further in view of the size of the Buccalin tablet, it should not be used in children below 2 years of age; the indication should be revised accordingly.
Nadalje se zdravilo Buccalin zaradi velikosti tablet ne sme uporabljati pri otrocih, mlajših od 2 let; indikacijo je treba ustrezno popraviti.
The composition, the manufacturing, the formulation, the administered dose, the treatment schedule and the route of administration of different bacterial lysates available in human therapy are heterogeneous.
Sestava, izdelava, formulacija, dani odmerek, razpored zdravljenja in pot uporabe različnih bakterijskih lizatov, ki so na voljo za zdravljenje ljudi, so raznoliki.
On 8 June 2018 the Italian National Competent Authority (AIFA) therefore triggered a referral under Article 31 of Directive 2001/83/EC and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of bacterial lysates-containing medicinal products for respiratory conditions and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Zato je italijanski pristojni nacionalni organ (AIFA) 8. junija 2018 sprožil napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor CHMP zaprosil, naj oceni vpliv zgoraj navedenih pomislekov na razmerje med tveganji in koristmi zdravil, ki vsebujejo bakterijske lizate, za bolezni dihal ter izda mnenje o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno preklicati ali ukiniti.
The products have different names in the MS and whilst the most common name is used herein it should be understood as applying to all associated names.
Zdravila imajo v državah članicah različna imena; tu se sicer uporablja najpogostejše ime, vendar se nanaša na vsa povezana imena.
The scope of this procedure is limited to respiratory tract conditions.
Obseg tega postopka je omejen na bolezni dihal.
• The Committee for Medicinal Products for Human Use (CHMP) considered the procedure under Article 31 of Directive 2001/83/EC for bacterial lysates based medicinal products for use in respiratory conditions.
• Odbor za zdravila za uporabo v humani medicini (CHMP) je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila na osnovi bakterijskih lizatov za uporabo pri boleznih dihal;
This included the responses submitted by the marketing authorisation holders in writing and during Oral Explanations, the information submitted by a third party, as well as the views expressed by the scientific advisory group on anti-infectives.
To je vključevalo tudi odgovore, ki so jih pisno in med ustno obrazložitvijo predložili imetniki dovoljenj za promet z zdravilom, informacije, ki so jih predložile tretje osebe, ter mnenja znanstvene posvetovalne skupine strokovnjakov za antiinfektive;
Depending on MS, the paediatric indication covers children from 1 year, 6 months, or without restrictions.
Odvisno od države članice pediatrična indikacija zajema otroke, stare 1 leto in več, 6 mesecev ali brez omejitve.
Having reviewed the appropriateness of the formulations and pharmaceutical forms for use in the authorised paediatric populations up to 5 years of age, the CHMP considered that acceptability studies in children below the age of 5 years should be performed for Respivax, Buccalin, Ismigen, Polyvaccinum suspension for injection.
Po pregledu ustreznosti formulacij in farmacevtskih oblik za uporabo pri odobrenih pediatričnih populacijah do starosti 5 let je odbor CHMP menil, da je treba za zdravila Respivax, Buccalin in Ismigen ter suspenzijo za injiciranje Polyvaccinum opraviti študije sprejemljivosti pri otrocih, mlajših od 5 let.
Some indications currently specify that the products should be used for bacterial infections only; however, there are no grounds for this claim as in the available studies no diagnosis of the pathogen was performed.
Pri nekaterih indikacijah je trenutno navedeno, da je treba zdravila uporabljati samo pri bakterijskih okužbah, vendar ta trditev ni utemeljena, saj v razpoložljivih študijah niso izvajali diagnostike povzročiteljev.
It is noted that the authors of a review article on immunomodulators for the prevention of RTI in children (Cardinale, 2015) concluded that no sufficient evidence for the efficacy of Luivac in the paediatric field was available.
Treba je opozoriti, da so avtorji preglednega članka o imunomodulatorjih za preprečevanje okužb dihal pri otrocih (Cardinale, 2015) zaključili, da na pediatričnem področju ni na voljo dovolj dokazov o učinkovitosti zdravila Luivac.
The safety information from both clinical trials and pharmacovigilance data was in line with the known safety profile, as described in the product information; rare hypersensitivity/allergic reactions have been reported.
Informacije o varnosti iz obeh kliničnih preskušanj in farmakovigilančnih podatkov so bile v skladu z znanim varnostnim profilom, kot je opisan v informacijah o zdravilu; poročali so o redkih preobčutljivostnih/alergijskih reakcijah.
Therefore, the CHMP considered that the treatment indication is not appropriate and should be removed.
Zato je menil, da indikacija za zdravljenje ni primerna in jo je treba izbrisati;
Of note, the Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases does not recommend oral bacterial lysates for the management of adult LRTI (Woodhead, 2011).
Opozoriti je treba, da delovna skupina Evropskega združenja za dihala (European Respiratory Society) in Evropskega združenja za klinično mikrobiologijo in prenosljive bolezni (European Society for Clinical Microbiology and Infectious Diseases) ne priporoča peroralnih bakterijskih lizatov za obravnavo okužb spodnjih dihal pri odraslih (Woodhead, 2011).
It was also agreed that the treatment indication was not intended to indicate a curative effects but rather to that the products could be used to prevent complications of RTIs or further infections.
Dogovorjeno je bilo tudi, da indikacija za zdravljenje ne pomeni kurativnih učinkov, pač pa, da se zdravila lahko uporabljajo za preprečevanje zapletov okužb dihal ali nadaljnjih okužb.
Therefore, and taking into account the known very rare risk of serious immunological reactions associated to these products, AIFA considered it to be in the interest of the Union to review the impact of these concerns on the benefit-risk balance of the class of bacterial lysates-based products in their authorised indications for respiratory infections.
Zato in ob upoštevanju znanega, zelo redkega tveganja za resne imunološke reakcije, povezane s temi zdravili, je organ AIFA ocenil, da je pregled vpliva teh pomislekov na razmerje med tveganji in koristmi razreda zdravil na osnovi bakterijskih lizatov pri njihovih odobrenih indikacijah za okužbe dihal v interesu Unije.
Bacterial lysates-based medicinal products contain several strains of inactivated whole bacteria/bacterial lysates/bacterial fractions claimed to stimulate the immune system to recognise and fight infections.
Zdravila na osnovi bakterijskih lizatov vsebujejo več sevov inaktiviranih celih bakterij/bakterijskih lizatov/bakterijskih frakcij, ki naj bi stimulirali imunski sistem k prepoznavanju okužb in boju proti njim.
Bacterial lysates-based medicinal products are authorised in various indications including the prevention and/or treatment of different types of respiratory infections.
Zdravila na osnovi bakterijskih lizatov so odobrena za različne indikacije, vključno s preprečevanjem in/ali zdravljenjem različnih vrst okužb dihal.
The MAHs are encouraged to seek scientific advice to the relevant competent authorities to design these studies.
Imetnike dovoljenj za promet z zdravilom se spodbuja, naj pri snovanju teh študij uporabijo znanstveno svetovanje pri pristojnih organih.
Overall the data available are of poor quality and do not provide robust evidence of the efficacy of these products in their authorised indications.
V celoti so razpoložljivi podatki slabe kakovosti in ne zagotavljajo zanesljivih dokazov o učinkovitosti teh zdravil pri njihovih odobrenih indikacijah.
• The CHMP considered that the safety data reviewed was in accordance with the known profile of the products.
• odbor CHMP je menil, da so pregledani podatki o varnosti v skladu z znanim profilom zdravil;
The analysis of the scientific data concerning bacterial lysates used for the prophylaxis and treatment of RTI was not able to elucidate the mechanism of action of these products.
Z analizo znanstvenih podatkov o bakterijskih lizatih, ki se uporabljajo za profilakso in zdravljenje okužb dihal, ni bilo mogoče pojasniti mehanizma delovanja teh zdravil.
In one MS the indication in children is limited to bacterial RURTI, while in five others it is also generally authorised as immunotherapy.
V eni državi članici je indikacija pri otrocih omejena na ponavljajoče se bakterijske okužbe zgornjih dihal, v petih drugih pa je zdravilo na splošno odobreno kot imunoterapija.
Finally the CHMP noted that Polyvaccinum-containing products contain phenol, an excipient that should be avoided.
Končno je odbor CHMP opozoril, da izdelki, ki vsebujejo zdravilo Polyvaccinum, vsebujejo fenol, pomožno snov, ki se ji je treba izogibati.
The MAH will register reformulated products without phenol by Q1 2022.
Imetnik dovoljenja za promet z zdravilom bo reformulirana zdravila brez fenola registriral do prvega četrtletja leta 2022.
Respiratory tract infections may be differentiated in upper and lower respiratory tract infections.
Okužbe dihal lahko ločimo na okužbe zgornjih in spodnjih dihal.
The CHMP noted that underreporting is probable.
Odbor CHMP je opozoril, da obstaja verjetnost pomanjkljivega poročanja.
The review of the safety profile of Broncho-Vaxom confirmed the known risk serious hypersensitivity reactions, in particular two life-threatening cases of anaphylactic reactions and one report of toxic epidermal necrolysis in a 5 year old for which the causality remains uncertain were noted.
Pregled varnostnega profila zdravila Broncho-Vaxom je potrdil znano tveganje za resne preobčutljivostne reakcije, predvsem so opazili dva smrtno nevarna primera anafilaktičnih reakcij in en primer toksične epidermalne nekrolize pri petletnem otroku, za katere vzročna povezava ostaja negotova.
The review of the safety profile of Ismigen confirmed the known risk serious hypersensitivity reactions.
Pregled varnostnega profila zdravila Ismigen je potrdil znano tveganje za resne preobčutljivostne reakcije.
A few studies with significant methodological limitations reported on favourable results with the suspension for injection and the nasal drops.
Iz nekaj študij s pomembnimi metodološkimi omejitvami so poročali o ugodnih rezultatih s suspenzijo za injiciranje in kapljicami za nos.
No patient with COPD or chronic bronchitis appears to have been included in the available studies.
Kaže, da v razpoložljive študije ni bil vključen noben bolnik s KOPB ali kroničnim bronhitisom.
Considering these clarifications and the absence of data showing a clinical effect in treatment setting, the CHMP was of the view that the treatment indication does not appropriately reflect the intended use of the products and any reference to a treatment effect should be deleted.
Glede na ta pojasnila in odsotnost podatkov, ki bi dokazovali klinični učinek pri zdravljenju, je odbor CHMP menil, da indikacija za zdravljenje ne odraža ustrezno predvidene uporabe zdravil, zato je treba vsako navedbo o učinku zdravljenja izbrisati.
Two cases of Guillain-Barre syndrome were recorded for which causality remains unknown due to a lack of information and without proper age-stratified observed versus expected analysis.
Zabeležena sta bila dva primera Guillain-Barréjevega sindroma, za katera vzročna povezava zaradi pomanjkanja informacij in odsotnosti ustrezne starostno stratificirane analize dejanskega stanja v primerjavi s pričakovanim ostaja neznana.
Limited evidence of efficacy in the prophylaxis of RTIs in children is mainly based on a retrospective study.
Omejeni dokazi o učinkovitosti pri profilaksi okužb dihal pri otrocih v glavnem temeljijo na retrospektivni študiji.
The CHMP noted that whilst serious LRTI can be clearly distinguished from URTI (e.g. exacerbation of asthma, pneumonia), numerous URTI may lead to involvement of the bronchi.
Odbor CHMP je opozoril, da lahko, čeprav se resne okužbe spodnjih dihal zlahka ločijo od okužb zgornjih dihal (npr. poslabšanje astme, pljučnica), številne okužbe zgornjih dihal privedejo do prizadetosti bronhijev.
Overall 9 ADRs were recorded over the last 16 years which may indicate serious under-reporting.
V zadnjih 16 letih je bilo skupaj zabeleženih devet neželenih učinkov, kar lahko kaže na zelo pomanjkljivo poročanje.
Lower respiratory tract infection (LRTI) is a broad description of a group of disease entities, encompassing acute bronchitis, pneumonia and exacerbations of chronic lung disease.
Okužba spodnjih dihal je širok opis skupine bolezni, ki vključujejo akutni bronhitis, pljučnico in poslabšanja kroničnih pljučnih bolezni.
Only a few ADRs have been collected over the last 12 year which may indicate serious under-reporting.
V zadnjih 12 letih je bilo zbranih le malo poročil o neželenih učinkih, kar lahko kaže na zelo pomanjkljivo poročanje.
For Respivax, Lantigen B, Ismigen and Polyvaccinum, no data was identified in the treatment of RTIs, while for Broncho-Vaxom the data available present major methodological limitations and represented a small sample size.
Za zdravila Respivax, Lantigen B, Ismigen in Polyvaccinum ni bilo najdenih podatkov o zdravljenju okužb dihal, razpoložljivi podatki o zdravilu Broncho-Vaxom pa so metodološko omejeni in predstavljajo majhen vzorec.
More recent studies with more robust design report conflicting results as one study failed to show a statistically significant effect over placebo in adults and in children whilst the statistically significant results of the other study conducted in adults only should be interpreted with caution in view of the noted methodological deficiencies (Braido, 2014).
Iz zanesljiveje zasnovanih novejših študij poročajo o nasprotujočih si rezultatih, saj v eni študiji niso uspeli dokazati statistično značilnega učinka v primerjavi s placebom pri odraslih in otrocih, statistično značilne rezultate druge študije, opravljene samo pri odraslih, pa je treba interpretirati previdno, z upoštevanjem opaženih metodoloških pomanjkljivosti (Braido, 2014).
A serious under-reporting is suspected.
Obstaja sum na zelo pomanjkljivo poročanje.
• The CHMP considered that overall the data available presents serious limitations and does not provide robust evidence of the efficacy of the products in their authorised indications.
• odbor CHMP je ocenil, da imajo razpoložljivi podatki v celoti resne omejitve in ne zagotavljajo zanesljivih dokazov o učinkovitosti zdravil pri njihovih odobrenih indikacijah.
• The CHMP also considered the lack of evidence from clinical studies in the use of these products for the prevention of pneumonia, a severe infection, and therefore was of the view that it should not be recommended.
• odbor CHMP je upošteval tudi pomanjkanje dokazov iz kliničnih študij pri uporabi teh zdravil za preprečevanje pljučnice, torej hude okužbe, zato je menil, da se zdravila v ta namen ne smejo priporočati;
A recent RCT provided limited evidence for some positive effects in the prophylaxis of RTIs in adults (statistically significant improvement in the number of days with RTI); the clinical relevance of these results is questionable considering that no superiority over placebo was observed for important secondary endpoints.
Nedavno randomizirano klinično preskušanje je zagotovilo omejene dokaze o nekaterih pozitivnih učinkih pri profilaksi okužb dihal pri odraslih (statistično značilno izboljšanje pri številu dni z okužbo dihal); klinični pomen teh rezultatov je vprašljiv, saj pri pomembnih sekundarnih opazovanih dogodkih ni bilo opažene superiornosti v primerjavi s placebom.
More recent well designed RCTs (e.g. AIACE, ACASP, CLEARI) failed to demonstrate efficacy of Ismigen in adults with COPD, Luivac in adults mainly with URTI and Ribomunyl in children with URTI, albeit in some these studies the background infection rate was very low, thus complicating the interpretation of the results.
Z novejšimi dobro zasnovanimi randomiziranimi kliničnimi preskušanji (npr. AIACE, ACASP, CLEARI) niso dokazali učinkovitosti zdravila Ismigen pri odraslih s KOPB, zdravila Luivac pri odraslih večinoma z okužbami zgornjih dihal in zdravila Ribomunyl pri otrocih z okužbami zgornjih dihal, vendar pa je bila osnovna stopnja okužb pri nekaterih od teh študij zelo nizka, kar otežuje interpretacijo rezultatov.
Therefore, no definite conclusion could be drawn on the efficacy in the prophylaxis indication based on the available data.
Zato na podlagi razpoložljivih podatkov ni mogoče izpeljati dokončnega zaključka o učinkovitosti pri indikaciji profilakse.
• The CHMP considered the totality of the data submitted for bacterial lysates based medicinal products for use in respiratory conditions.
• odbor CHMP je ocenil vse predložene podatke o zdravilih na osnovi bakterijskih lizatov za uporabo pri boleznih dihal.
Further, considering the severity of pneumonia, the CHMP considered that a warning should be added in the SmPC of all products with the unspecified RTI indication to recommend against the use in the prevention of pneumonia in view of the absence of data demonstrating the efficacy for the prophylaxis of this type of infection.
Z upoštevanjem resnosti pljučnice je odbor CHMP nadalje menil, da je treba v povzetek glavnih značilnosti zdravila za vsa zdravila z neopredeljeno indikacijo za okužbe dihal dodati priporočilo proti uporabi teh zdravil pri preprečevanju pljučnice, saj ni podatkov, ki bi dokazovali učinkovitost profilakse za tovrstno okužbo.
The SAG AI considered that the data indicate some efficacy of these products in the prophylactic setting only in relation to URTIs, as a secondary prevention, for populations at increased risk.
Skupina SAG AI je ocenila, da podatki kažejo na določeno učinkovitost teh zdravil samo pri profilaksi v povezavi z okužbami zgornjih dihal kot sekundarna preventiva za populacije, pri katerih obstaja povečano tveganje.
No robust study was conducted for Respivax.
Z zdravilom Respivax ni bila opravljena nobena zanesljiva študija.
Post-marketing reports concerned mostly injection site reactions for one presentation and “flu like” signs and symptoms for the other one.
Poročila iz obdobja trženja so se nanašala predvsem na reakcije na mestu injiciranja pri eni obliki ter gripi podobne znake in simptome pri drugi obliki.
• The CHMP considered the lack of evidence in the treatment settings and that the treatment wording was not reflective of the intended clinical use for this indication.
• odbor CHMP je upošteval pomanjkanje dokazov pri zdravljenju in ocenil, da besedilo v povezavi z zdravljenjem ne odraža predvidene klinične uporabe pri tej indikaciji.
Three double-blind RCTs conducted in children and adults showed the statistically significant superiority of Luivac over placebo with regards to a non-validated severity score used as primary endpoint, thus precluding conclusions as to the clinical relevance of the results.
Tri dvojno slepa randomizirana klinična preskušanja pri otrocih in odraslih so pokazala statistično značilno superiornost zdravila Luivac v primerjavi s placebom glede nevalidirane ocene resnosti, ki je bila uporabljena kot primarni opazovani dogodek, zato ni bilo mogoče izpeljati zaključkov o kliničnem pomenu rezultatov.
Bacterial lysates are approved in EU member states under a broad spectrum of indications that can generally be categorised as prophylaxis and treatment of URTIs and LRTIs in adults and children.
Bakterijski lizati so v državah članicah EU odobreni za širok spekter indikacij, ki jih na splošno lahko razdelimo na profilakso in zdravljenje okužb zgornjih dihal in okužb spodnjih dihal pri odraslih in otrocih.
In a fourth doubleblind placebo controlled RCT conducted in adults only, the background infection rate was very low and superiority over placebo was shown.
V četrtem dvojno slepem, s placebom nadzorovanem randomiziranem kliničnem preskušanju, opravljenem samo pri odraslih, je bila osnovna stopnja okužb zelo nizka in dokazali so superiornost v primerjavi s placebom.
No study evaluating the effect of Ismigen in the treatment of RTIs was identified.
Študij, ki bi ocenjevale učinek zdravila Ismigen pri zdravljenju okužb dihal, niso našli.
• Therefore, the CHMP considered that the benefit-risk balance of bacterial lysates based medicinal products for use in respiratory conditions is unchanged in the prophylaxis setting provided the efficacy and safety of the products are further characterised through the conduct of appropriate phase IV double-blind, multicentre, RCT(s).
• odbor CHMP je zato ocenil, da razmerje med tveganji in koristmi zdravil na osnovi bakterijskih lizatov za uporabo pri boleznih dihal pri profilaksi ostaja nespremenjeno, pod pogojem, da se nadalje opredelita njihova varnost in učinkovitost, in sicer z izvedbo ustreznih dvojno slepih, multicentričnih randomiziranih kliničnih preskušanj IV. faze.
Upper respiratory tract infection (URTI) is a non-specific term used to describe acute infections involving the nose, paranasal sinuses, pharynx, and larynx.
Okužba zgornjih dihal je nespecifičen izraz, ki se uporablja za opis akutnih okužb nosu, obnosnih sinusov, žrela in grla.
CHMP opinion The CHMP, as a consequence, considers that the benefit-risk balance of bacterial lysates based medicinal products for use in respiratory conditions remains favourable subject to the amendments to the product information and to the conditions described above.
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil na osnovi bakterijskih lizatov za uporabo pri boleznih dihal še naprej ugodno, če se upoštevajo zgoraj opisane spremembe informacij o zdravilu in pogojev.
In conclusion, the CHMP considers the benefit-risk balance of bacterial lysates based products for use in respiratory conditions unchanged in the prophylaxis setting with regard to their authorised subsets of recurrent RTIs, provided their efficacy and safety is further characterised by Q1 2026 through the conduct of phase IV double-blind, multicentre, RCTs in this indication, and provided the agreed changes to the product information are implemented.
Odbor CHMP je končno sklenil, da razmerje med tveganji in koristmi zdravil, ki temeljijo na bakterijskih lizatih, za uporabo pri profilaksi bolezni dihal ostaja nespremenjeno, kar zadeva njihove odobrene podskupine ponavljajočih se okužb dihal, pod pogojem, da se do prvega četrtletja leta 2026 nadalje opredelita njihova varnost in učinkovitost, in sicer z izvedbo dvojno slepih, multicentričnih randomiziranih kliničnih preskušanj IV. faze pri tej indikaciji, in pod pogojem, da se uvedejo dogovorjene spremembe informacij o zdravilu.
The SAG also considered that extrapolation of clinical effects in prophylaxis of upper and lower RTI to treatment of these infections, and vice versa was not scientifically justified, which was agreed by CHMP.
Skupina SAG je menila tudi, da ekstrapolacija kliničnih učinkov pri profilaksi okužb zgornjih in spodnjih dihal na zdravljenje teh okužb in obratno ni znanstveno utemeljena, s čimer se je strinjal tudi odbor CHMP.
A small doubleblind placebo-controlled RCT and some supportive studies with methodological limitations provide some evidence of efficacy of Ismigen in the prophylaxis of URTIs in adults.
Majhno, dvojno slepo, s placebom nadzorovano randomizirano klinično preskušanje in nekaj podpornih študij z metodološkimi omejitvami zagotavlja nekaj dokazov o učinkovitosti zdravila Ismigen pri profilaksi okužb zgornjih dihal pri odraslih.