FrancophonIA/ELRC3.0 huggingface dataset:
English: For these reasons studies conducted after the initial marketing authorisation do not provide new significant scientific data on the efficacy of the products.
Slovenian: Zato študije, opravljene po prvotnem dovoljenju za promet z zdravilom, ne zagotavljajo novih pomembnih znanstvenih podatkov o učinkovitosti zdravil.
English: However, when looking at the date of the reports, 40 reports, out of the 119 reported in total for the originator since the first marketing authorisation, appear to have been sent in two batches by the Chinese health authority to the MAH of the originator of these products.
Slovenian: Pri pregledu datumov teh poročil pa so ugotovili, da je od prve odobritve dovoljenja za promet z zdravilom 40 od skupno 119 poročil za originator imetniku dovoljenja za promet z originatorjem teh zdravil v dveh serijah poslal kitajski zdravstveni organ.
English: In addition, the PRAC discussed the need to conduct post-authorisation studies, and concluded that such studies would likely not generate new robust information towards more definite conclusions.
Slovenian: Poleg tega je odbor PRAC razpravljal o potrebi po izvedbi študij po izdaji dovoljenja za promet z zdravilom in zaključil, da iz tovrstnih študij verjetno ne bi pridobili novih grobih informacij, ki bi omogočile izpeljavo dokončnejših zaključkov.
English: The clinical studies performed during the development of bromhexine- and ambroxol-containing products between the 1950ies and 1980ies were considerably less standardised than would be necessary today, and would not completely fulfil contemporary requirements with regard to validated endpoints, statistical confirmation, or Good Clinical Practice (GCP).
Slovenian: Klinične študije, izvedene med razvojem bromheksina in ambroksola v času med 50-imi in koncem 80-ih let prejšnjega stoletja, so bile precej manj standardizirane, kot je zahtevano danes, zato delno ne izpolnjujejo sodobnih zahtev glede validiranih opazovanih dogodkov, statistične potrditve ali dobre klinične prakse.
English: Some trials failed to show a significant difference between ambroxol or bromhexine and placebo and other only showed significant difference in some of the studied endpoints.
Slovenian: Nekatera preskušanja niso uspela pokazati pomembne razlike med ambroksolom ali bromheksinom in placebom, druga pa so pomembno razliko pokazala samo pri nekaterih preiskovanih opazovanih dogodkih.
English: Therefore the PRAC concluded that the evidence available did not justify the introduction of further age specific restrictions in the product information.
Slovenian: Odbor PRAC je zato zaključil, da razpoložljivi dokazi niso upravičili uvedbe dodatnih, za starost specifičnih omejitev v informacije o zdravilu.
English: This increase in reporting follows the implementation of a new pharmacovigilance regulation in China that might have influenced adverse reaction reporting and does not reflect a new safety concern.
Slovenian: To povečanje poročanja je posledica uvedbe novega farmakovigilančnega predpisa na Kitajskem, ki je morda vplival na poročanje neželenih učinkov in ne predstavlja novega varnostnega zadržka.
English: On 25 February 2015, the CMDh, having considered the PRAC recommendation, dated 9 January 2015, reached by majority the position that the marketing authorisations for the concerned medicinal products should be varied.
Slovenian: Po preučitvi priporočila odbora PRAC z dne 9. januarja 2015 je skupina CMDh 25. februarja 2015 z večino glasov sprejela stališče, da je treba dovoljenja za promet z zadevnimi zdravili spremeniti.
English: Taking into account these limitations, together with the weak evidence of a safety issue from the pharmacovigilance data, the PRAC could not conclude from the available evidence that risks outweighed benefits in the different indications.
Slovenian: Upoštevajoč te omejitve skupaj s šibkimi dokazi o varnostnih zadržkih iz farmakovigilančnih podatkov odbor PRAC na podlagi razpoložljivih dokazov ni mogel zaključiti, ali so tveganja pri različnih indikacijah večja od koristi.
English: Four cases of SCARs retrieved from Eudravigilance and 3 others from the literature have been assessed as related to ambroxol.
Slovenian: Štiri primere SCAR iz sistema Eudravigilance in tri druge primere iz literature so ocenili kot povezane z ambroksolom.
English: Overall conclusion and grounds for the revised PRAC recommendation
Slovenian: Splošni zaključki in podlaga za revidirano priporočilo odbora PRAC Ob upoštevanju naslednjega:
English: In light of the above, on 4 April 2014, the FAMHP informed the European Medicines Agency, of their decision to notify a referral procedure to ask for the PRAC's recommendation pursuant to Article 31 of Directive 2001/83/EC, on whether the balance of benefits and risks for these products is still positive in the approved indications, and whether the marketing authorisations for ambroxol- and bromhexinecontaining medicinal products should be maintained, varied, suspended or withdrawn.
Slovenian: Na podlagi zgornjih podatkov je organ FAMHP 4. aprila 2014 obvestil Evropsko agencijo za zdravila o svoji odločitvi, da bo sprožil napotitveni postopek in odbor PRAC v skladu s členom 31 Direktive 2001/83/ES zaprosil za priporočilo o tem, ali je razmerje med tveganji in koristmi teh zdravil pri odobrenih indikacijah še vedno pozitivno ter ali naj se dovoljenja za promet z zdravili, ki vsebujejo ambroksol in bromheksin, ohranijo, spremenijo, začasno umaknejo ali odvzamejo.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for ambroxol- and bromhexine-containing medicinal products.
Slovenian: • odbor PRAC je upošteval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov predložena za zdravila, ki vsebujejo ambroksol in bromheksin;
English: All the available data submitted, related to the safety and the efficacy of the medicinal products were reviewed by the PRAC to assess the potential impact of the new safety concerns identified on the established benefit-risk balance of the authorised medicinal products.
Slovenian: Odbor PRAC je pregledal vse razpoložljive predložene podatke v zvezi z varnostjo in učinkovitostjo zdravil, da bi ocenil morebitni vpliv novih varnostnih zadržkov na ugotovljeno razmerje med tveganji in koristmi odobrenih zdravil.
English: The PRAC took note of the advice of the paediatric committee (PDCO) that the use of ambroxol and bromhexine varies significantly in paediatric clinical practice across the EU.
Slovenian: Odbor PRAC je upošteval nasvet pediatrične komisije (PDCO), da se uporaba ambroksola in bromheksina v klinični praksi v EU precej razlikuje.
English: Efficacy issues
Slovenian: Vprašanja glede učinkovitosti
English: As SCARs sometimes start with flu-like symptoms some patients might also start taking ambroxol or bromhexine to alleviate these symptoms whereas the typical skin reactions appear later and ambroxol or bromhexine might be considered as suspect drug.
Slovenian: Ker se SCAR včasih začne z gripi podobnimi simptomi, lahko nekateri bolniki začnejo jemati tudi ambroksol ali bromheksin za lajšanje teh simptomov, čeprav se značilne kožne reakcije pojavijo pozneje, zato se morda ambroksol ali bromheksin obravnavata kot povzročitelja.
English: Based on these data it is considered that the susceptibility of all age groups (paediatric, adults and elderly) to putative hypersensitivity-related undesirable effects of ambroxol or bromhexine is likely similar.
Slovenian: Na podlagi teh podatkov so menili, da je dovzetnost vseh starostnih skupin (pediatričnih, odraslih in starejših) za domnevne, s preobčutljivostjo povezane neželene učinke ambroksola ali bromheksina verjetno podobna.
English: Many patients with SCARs receive various mucolytic or secretolytic agents in the relevant time period before the onset of their adverse event.
Slovenian: Mnogi bolniki s SCAR pred pojavom neželenega dogodka v zadevnem časovnem obdobju prejemajo različne mukolitične ali sekretolitične učinkovine.
English: However, these adverse reactions are already listed in the product information of most ambroxol- and bromhexinecontaining products and the analysis of the most frequently reported adverse events selected by the SMQ Hypersensitivity (broad) did not identify any new safety concerns.
Slovenian: Vendar so ti neželeni učinki že navedeni v informacijah o zdravilu, ki veljajo za večino zdravil, ki vsebujejo ambroksol in bromheksin, analiza najpogosteje poročanih neželenih dogodkov, izbranih na podlagi (široke) opredelitve SMQ za preobčutljivost, pa ni pokazala novih zadržkov v zvezi z varnostjo.
English: The safety information submitted by the MAHs, from Eudravigilance and from the literature, comprises in total around 300 case reports of suspected SCARs, many of which have possible confounders.
Slovenian: Varnostni podatki, ki so jih predložili imetniki dovoljenj za promet z zdravilom, iz sistema Eudravigilance in literature, vključujejo skupno približno 300 poročil o primerih suma na SCAR, od katerih jih ima mnogo morebitne zavajajoče dejavnike.
English: In addition the PRAC recommended harmonising the terms related to hypersensitivity reactions in the product information.
Slovenian: Poleg tega je odbor PRAC priporočil, da se v informacijah o zdravilu izrazi, povezani s preobčutljivostnimi reakcijami, uskladijo.
English: • The PRAC reviewed the totality of the data submitted in support of the safety and efficacy of ambroxol- and bromhexine-containing products, including submissions from the marketing authorisation holders and expert input.
Slovenian: • odbor PRAC je pregledal vse podatke, predložene v podporo varnosti in učinkovitosti zdravil, ki vsebujejo ambroksol in bromheksin, vključno z vlogami imetnikov dovoljenja za promet z zdravilom in mnenji strokovnjakov;
English: The PRAC, as a consequence, concluded that the benefit-risk balance of of ambroxol- and bromhexinecontaining medicinal products remains favourable, subject to the above detailed amendments to the product information.
Slovenian: Posledično je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo ambroksol in bromheksin, še naprej ugodno pod pogojem, da se upoštevajo zgornje podrobne spremembe informacij o zdravilu.
English: In addition, ambroxol formulations indicated in secretolytic therapy and prophylaxis or treatment of IRDS and PPC have been associated with delayed-onset hypersensitivity reactions without severe skin injury.
Slovenian: Poleg tega so bile formulacije ambroksola, indicirane za sekretolitično terapijo in profilakso ali zdravljenje IRDS ter PPC, povezane z zapoznelimi preobčutljivostnimi reakcijami brez hude kožne poškodbe.
English: Taking all of the above into consideration, the PRAC concluded that the data reviewed supported amendments of the product information to reflect the risk of severe cutaneous adverse reactions, and that further age restrictions to reflect the concerns about the benefit-risk balance of ambroxol- and bromhexine-containing products are not justified on the basis of the data available.
Slovenian: Upoštevajoč vse zgornje podatke je odbor PRAC zaključil, da pregledani podatki podpirajo spremembe informacij o zdravilu, in sicer tako, da se vanje vključi tveganje hudih kožnih neželenih učinkov, in da dodatne omejitve glede starosti, ki odražajo pomisleke o razmerju med tveganji in koristmi zdravil, ki vsebujejo ambroksol in bromheksin, niso upravičene na podlagi razpoložljivih podatkov.
English: An increase was observed in the reporting frequency of anaphylactic reactions over 2012-2014 linked to ambroxol.
Slovenian: Med letoma 2012 in 2014 so opazili povečanje pogostosti poročanja o anafilaktičnih reakcijah, povezanih z ambroksolom.
English: Analysis of the safety information submitted by the MAH, from Eudravigilance and from the literature, demonstrates that ambroxol and bromhexine formulations in their different indications have been associated with reports of serious immediate hypersensitivity reactions.
Slovenian: Analiza varnostnih podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, iz sistema Eudravigilance in literature, kaže, da so bile formulacije ambroksola in bromheksina pri različnih indikacijah povezane s poročili o takojšnjih resnih preobčutljivostnih reakcijah.
English: In addition, ambroxol and bromhexine have been approved in some EU MS in airway diseases indications in fixed dose combinations with various active substances.
Slovenian: Poleg tega sta se ambroksol in bromheksin v nekaterih državah članicah EU odobrila za indikacijo bolezni dihal v kombinacijah z različnimi zdravilnimi učinkovinami s fiksnim odmerkom.
English: As ambroxol is a metabolite of bromhexine and hypersensitivity reactions are not dependent on the dose of the allergenic substance absorbed, the FAMHP considered that any confirmed risk with ambroxol could also be found in bromhexine-containing medicinal products with regards to these reactions.
Slovenian: Ker je ambroksol presnovek bromheksina in preobčutljivostne reakcije niso odvisne od odmerka absorbiranega alergena, je organ FAMHP menil, da bi lahko potrjeno tveganje za te reakcije pri ambroksolu veljalo tudi za zdravila, ki vsebujejo bromheksin.
English: The authorised indications of bromhexine, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, alteration in the production or elimination of mucus (acute and chronic sinusitis) and Sjögren's syndrome.
Slovenian: Odobrene indikacije za bromheksin, kot je navedeno v glavnem podatkovnem listu imetnika dovoljenja za originator, so sekretolitična terapija, spremembe v tvorbi ali izločanju sluzi (akutni in kronični sinusitis) ter Sjögrenov sindrom.
English: The PRAC was of the view that the possible risk of SCARs can be adequately addressed by the proposed amendments to the PI to inform caregivers and patients of the risk and allow early identification of signs of SCARs and immediate discontinuation of treatment should they occur.
Slovenian: Odbor PRAC je menil, da se lahko morebitno tveganje za SCAR zadostno obravnava s predlaganimi spremembami informacij o zdravilu, ki bodo negovalce in bolnike obveščale o tveganju, omogočale zgodnje prepoznavanje znakov SCAR in opozarjale na takojšnjo prekinitev jemanja, če se taki znaki pojavijo.
English: It is acknowledged that clinical evidence from studies in children is weak due to their heterogeneity and to the lower number of children enrolled.
Slovenian: Znano je, da so zaradi heterogenosti in manjšega števila vključenih otrok klinični dokazi iz študij pri otrocih šibkejši.
English: Based on the evaluation of the individual case reports, considering the nature of these events the PRAC was of the view that there is a reasonable possibility that all ambroxol and bromhexine-containing products are associated with an increased risk of SCARs including combination products.
Slovenian: Na podlagi ocene posameznih poročil o primerih in glede na naravo teh dogodkov je odbor PRAC menil, da obstaja možnost, da so vsa zdravila, ki vsebujejo ambroksol in bromheksin, povezana s povečanim tveganjem za SCAR, vključno s kombiniranimi zdravili.
English: The PRAC however noted that the observed increase in reporting of anaphylactic reactions for ambroxol-containing products was likely an artefact resulting from the implementation of a new pharmacovigilance regulation in China and did not constitute a new safety concern.
Slovenian: Vendar je sklepal, da je opaženo povečanje poročanja o anafilaktičnih reakcijah na zdravila, ki vsebujejo ambroksol, verjetno artefakt, ki je posledica uvedbe novega farmakovigilančnega predpisa na Kitajskem, in ne predstavlja novega varnostnega zadržka.
English: In relation to the efficacy of ambroxol- and bromhexine-containing products, the PRAC concluded that although modest positive results were reported, the evidence of efficacy of ambroxol and bromhexine suffered from a number of limitations and deficiencies.
Slovenian: Glede učinkovitosti zdravil, ki vsebujejo ambroksol in bromheksin, je odbor PRAC zaključil, da imajo dokazi o učinkovitosti ambroksola in bromheksina kljub zmerno pozitivnim rezultatom mnoge omejitve in pomanjkljivosti.
English: The CMDh, having considered the revised PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and reached the position that the marketing authorisations for ambroxol- and bromhexine-containing medicinal products should be varied.
Slovenian: Po preučitvi revidiranega priporočila odbora PRAC se je skupina CMDh strinjala z njegovimi splošnimi znanstvenimi zaključki in menila, da je treba dovoljenja za promet z zdravili, ki vsebujejo ambroksol in bromheksin, spremeniti.
English: The PRAC considered that the evidence of risk of SCARs associated with ambroxol and bromhexine is weak.
Slovenian: Odbor PRAC je menil, da so dokazi o tveganju za SCAR, povezanem z ambroksolom in bromheksinom, šibki.
English: The PRAC considered all these elements in its review of the available data on the efficacy of ambroxol- and bromhexine-containing products.
Slovenian: Odbor PRAC je pri svojem pregledu razpoložljivih podatkov o učinkovitosti zdravil, ki vsebujejo ambroksol in bromheksin, upošteval vse te elemente.
English: When considering data in support of the safety issues, the PRAC was of the view that ambroxol- and bromhexine-containing products are associated with case reports of immediate and delayed hypersensitivity including hypersensitivity reactions, anaphylactic reactions including anaphylactic shock, angioedema, pruritus, rash and urticaria.
Slovenian: Na podlagi podatkov, ki podpirajo varnostne zadržke, je odbor PRAC menil, da so zdravila, ki vsebujejo ambroksol in bromheksin, povezana s poročili o primerih takojšnje in zapoznele preobčutljivosti, kot so preobčutljivostne reakcije, anafilaktične reakcije, vključno z anafilaktičnim šokom, angioedem, srbenje, izpuščaji in urtikarija.
English: • The PRAC was of the view that the risk of SCARs should be addressed by its inclusion in the product information accompanied by a warning in order for patients and caregivers to recognise the prodromes of SCARs and discontinue treatment immediately in the event of such signs.
Slovenian: • odbor PRAC je menil, da je treba tveganje za SCAR obravnavati tako, da se v informacije o zdravilu vključi opozorilo za bolnike in negovalce, kako prepoznati prodromske znake SCAR in da je treba takoj prekiniti zdravljenje, če se taki znaki pojavijo;
English: • The PRAC considered that ambroxol and bromhexine are associated with an increased risk of hypersensitivity reactions.
Slovenian: • odbor PRAC je menil, da sta ambroksol in bromheksin povezana s povečanim tveganjem preobčutljivostnih reakcij;
English: Hypersensitivity reactions are dose and formulation independent, therefore the possible risk of developing hypersensitivity reactions including SCARs is inherent to all ambroxol- and bromhexinecontaining products.
Slovenian: Preobčutljivostne reakcije niso odvisne od odmerka in formulacije, zato morebitno tveganje za razvoj preobčutljivostnih reakcij, vključno s SCAR, velja za vsa zdravila, ki vsebujejo ambroksol in bromheksin.
English: The authorised indications of ambroxol, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, prophylaxis and treatment of Infant Respiratory Distress Syndrome (IRDS), prophylaxis and treatment of post-operative bronchopulmonary complications (PPC) and pain relief in acute sore throat.
Slovenian: Odobrene indikacije za ambroksol, kot je navedeno v glavnem podatkovnem listu imetnika dovoljenja za originator, so sekretolitična terapija, profilaksa in zdravljenje sindroma respiratorne stiske pri dojenčkih, profilaksa in zdravljenje pooperacijskih bronhopulmonalnih zapletov ter lajšanje bolečine pri akutno bolečem žrelu.
English: Often a large placebo effect is seen in studies investigating respiratory conditions, particularly in non-serious, self-limiting conditions.
Slovenian: V študijah, ki preučujejo bolezni dihal, predvsem neresna, samoomejujoča stanja, pogosto opažajo velik učinek placeba.
English: With regards to delayed hypersensitivity reactions associated with SCARs, a few cases have been assessed as certainly related to ambroxol.
Slovenian: Nekaj primerov zapoznelih preobčutljivostnih reakcij, povezanih s SCAR, so ocenili kot zagotovo povezane z ambroksolom.
English: The PRAC considered that there was a reasonable possibility that ambroxol and bromhexine are associated with serious delayed-type hypersensitivity reactions associated with SCARs.
Slovenian: Odbor PRAC je menil, da obstaja možnost, da sta ambroksol in bromheksin povezana z resnimi preobčutljivostnimi reakcijami zapoznelega tipa, povezanimi s SCAR.
English: The CMDh considered the PRAC recommendation that the evidence available did not provide sufficient grounds to demonstrate a change to the established benefit-risk balance, provided the recommended amendments to sections 4.4 and 4.8 of the product information, detailed in annex III, are implemented.
Slovenian: Skupina CMDh je upoštevala priporočilo odbora PRAC, da razpoložljivi dokazi niso zadosten razlog za spremenjeno razmerje med tveganji in koristmi, pod pogojem, da se po priporočilih spremenita poglavji 4.4 in 4.8 informacij o zdravilu, kot je pojasnjeno v Prilogi III. Samo te spremembe, ki jih sprejme skupina CMDh in jih vključi v svoje stališče, so pravno zavezujoče in jih morajo države članice izvesti.
English: Nevertheless, modest but positive results were reported for ambroxol and bromhexine.
Slovenian: Kljub temu so pri ambroksolu in bromheksinu poročali o zmernih, vendar pozitivnih rezultatih.
English: • The PRAC considered that there is a reasonable possibility of a risk of SCARs associated with ambroxol and bromhexine.
Slovenian: • odbor PRAC je menil, da obstaja možnost tveganja za SCAR, povezanega z ambroksolom in bromheksinom;
English: These products are contra-indicated in different subsets of the paediatric population in the EU MS. Ambroxol and bromhexine are marketed in several formulations for oral, nasal, oromucosal, intravenous or rectal administration under various invented names.
Slovenian: Ambroksol in bromheksin se v več formulacijah in z različnimi izmišljenimi imeni tržita za peroralno, nazalno, oralno, intravensko in rektalno uporabo.
English: In addition, all studies conducted more recently submitted by the MAHs were also considered by the PRAC.
Slovenian: Poleg tega je odbor PRAC preučil vse študije, ki so jih predložili imetniki dovoljenj za promet z zdravili in so bile opravljene v zadnjem času.
English: Therefore, the PRAC recommends the variation to the terms of the marketing authorisations, for all ambroxol- and bromhexine-containing medicinal products identified in Annex I and for which the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III of the revised PRAC recommendation.
Slovenian: • odbor PRAC je menil, da razpoložljivi podatki niso zadostni za upravičenje novih starostnih omejitev; odbor PRAC je zato priporočil spremembo pogojev dovoljenj za promet z vsemi zdravili, ki vsebujejo ambroksol in bromheksin ter so navedena v Prilogi I, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III k revidiranemu priporočilu odbora PRAC.
English: Ambroxol- and bromhexine-containing medicines are available as over-the-counter (OTC) as well as prescription-only medicines (POM).
Slovenian: Zdravila, ki vsebujejo ambroksol in bromheksin, se izdajajo bodisi brez recepta bodisi le na recept.