FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs of chickens infected with Gumboro disease include trembling, ruffled feathers, poor appetite, dehydration, diarrhoea, huddling and depression.
Slovenian: Med znaki, ki so značilni za piščance, okužene z boleznijo Gumboro, so drgetanje, nasršeno perje, neješčnost, dehidracija, driska, stiskanje in depresija.
English: It is also the time required after administration of a medicine before eggs may be used for human consumption.
Slovenian: Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko jajca uporabijo za prehrano ljudi.
English: What benefits of Gumbohatch have been shown in studies?
Slovenian: Kakšne koristi zdravila Gumbohatch so se pokazale v študijah?
English: When the chicken comes into contact with a similar IBD virus, these antibodies, together with other components of the chicken's immune system, will be able to fight the infection and help protect it against the disease.
Slovenian: Ob izpostaviti podobnemu virusu IBD se bodo lahko ta protitelesa skupaj z drugimi sestavinami imunskega sistema piščanca borila proti okužbi in pripomogla k zaščiti piščanca pred boleznijo.
English: Hands and equipment should be washed and disinfected after use of the vaccine.
Slovenian: Po uporabi cepiva je treba roke in opremo oprati in razkužiti.
English: Why is Gumbohatch authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Gumbohatch odobreno v EU?
English: What are the risks associated with Gumbohatch?
Slovenian: Kakšna tveganja so povezana z zdravilom Gumbohatch?
English: An overview of Gumbohatch and why it is authorised in the EU
Slovenian: Pregled zdravila Gumbohatch in zakaj je odobreno v EU
English: The withdrawal period for meat and eggs from chickens treated with Gumbohatch is ‘zero' days, which means that there is no mandatory waiting time.
Slovenian: Karenca za meso in jajca piščancev, zdravljenih s cepivom Gumbohatch, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: What is Gumbohatch and what is it used for?
Slovenian: Kaj je zdravilo Gumbohatch in za kaj se uporablja?
English: The studies showed Gumbohatch to reduce clinical signs and damage to the bursa of Fabricius caused by very virulent (powerful) IBD virus infection, following vaccination of eggs or chicks.
Slovenian: Študije so pokazale, da je cepivo Gumbohatch zmanjšalo klinične znake in poškodbo burze Fabricij, ki jih povzroča zelo virulentna (močna) okužba z virusom IBD, po cepljenju jajc ali piščancev.
English: Gumbohatch contains a live strain of IBD virus (strain 1052) that has been weakened so that it does not cause the disease.
Slovenian: Cepivo Gumbohatch vsebuje živ sev virusa IBD (sev 1052), ki je bil oslabljen, tako da ne povzroča bolezni.
English: The vaccine should be used only in flocks that are known to have maternal antibodies (transmitted from the mother) against IBD virus.
Slovenian: Cepivo je treba uporabljati samo v jatah, za katere je znano, da imajo maternalna protitelesa (ki se prenašajo z matere) proti virusu IBD.
English: When a chick or chicken egg is given the vaccine, the immune system recognises the weakened virus in the vaccine as ‘foreign' and makes its own antibodies against the virus.
Slovenian: Ko piščanec ali kokošje jajce prejme cepivo, imunski sistem prepozna oslabljeni virus kot tujek in proti njemu tvori lastna protitelesa.
English: Gumbohatch is a vaccine used to protect broiler chickens (reared for meat) against infectious bursal disease (IBD) virus infection caused by a very virulent IBD virus.
Slovenian: Zdravilo Gumbohatch je cepivo, ki se uporablja za zaščito brojlerjev (piščancev, ki se vzrejajo za meso) pred okužbo z virusom infekcijske bolezni Gumboro (IBD), ki ga povzroča zelo virulenten virus IBD.
English: Gumbohatch contains small amounts of weakened IBD virus attached to antibodies.
Slovenian: Zdravilo Gumbohatch vsebuje majhne količine oslabljenega virusa IBD, ki je pritrjen na protitelesa.
English: The laboratory studies involved chicks with maternal antibodies against IBD virus.
Slovenian: V laboratorijske študije so bili vključeni piščanci z maternalnimi protitelesi proti virusu IBD.
English: Gumbohatch must not be used in flocks without maternal antibodies against IBD virus.
Slovenian: Cepivo Gumbohatch se ne sme uporabljati v jatah, ki so brez maternalnih protiteles proti virusu IBD.
English: How does Gumbohatch work?
Slovenian: Kako zdravilo Gumbohatch deluje?
English: Gumbohatch is available as a freeze dried powder (lyophilisate) and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Slovenian: Zdravilo Gumbohatch je na voljo v obliki praška, posušenega z zamrzovanjem (liofilizata), in vehikla za pripravo suspenzije za injiciranje.
English: Gumbohatch (infectious bursal disease vaccine live attenuated)
Slovenian: Gumbohatch (cepivo proti bolezni Gumboro, živo,
English: How is Gumbohatch used?
Slovenian: Kako se zdravilo Gumbohatch uporablja?
English: Conclusion and recommendations
Slovenian: Zaključki in priporočila
English: Pholcodine has been marketed for decades in the European Union, where currently marketing authorisations exist in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and United Kingdom, either subject to medical prescription or as non-prescription medicines.
Slovenian: Folkodin je na trgih Evropske unije že več desetletij, trenutno pa imajo dovoljenje za promet z zdravilom Belgija, Francija, Irska, Litva, Luksemburg, Malta, Slovenija, Španija in Združeno kraljestvo, kjer je na voljo na recept ali brez njega.
English: Very few cases have been described with a substance that has been extensively used for decades and that is even available in some countries without medical prescription.
Slovenian: Opisanih je zelo malo primerov s snovmi, ki se že desetletja razširjeno uporabljajo in ki so v nekaterih državah na voljo tudi brez zdravniškega recepta.
English: While the data from Sweden and Norway appear to be consistent, other factors can explain the observations.
Slovenian: Ker podatki s Švedske in Norveške kažejo doslednost, lahko opažanja razložijo drugi dejavniki.
English: The draft protocol of the study should be submitted to CHMP within 3 months of the Commission Decision.
Slovenian: Osnutek protokola študije bo Odboru za zdravila za uporabo v humani medicini predložen v treh mesecih po odločbi Komisije.
English: No study has been performed on the long term effects of pholcodine.
Slovenian: O dolgoročnih učinkih folkodina niso opravili nobene študije.
English: Ultimately, even if the prevalence of sensitisation is high, the clinical relevance of these findings is questionable.
Slovenian: Čeprav je prevalenca senzibilizacije velika, je klinični pomen teh izsledkov vprašljiv.
English: The published data refers mainly to Norway and Sweden, where pholcodine is no longer marketed.
Slovenian: Objavljeni podatki veljajo zlasti za Norveško in Švedsko, kjer folkodin ni več na trgu.
English: On 28 January 2011, France triggered a referral under Article 31 of Directive 2001/83/EC, as amended.
Slovenian: Dne 28. januarja 2011 je Francija sprožila napotitveni postopek v skladu s členom 31
English: This coincides with a 9% increase in the consumption of pholcodine-containing products in France between the two periods.
Slovenian: To sovpada z 9-odstotnim povečanjem porabe zdravil, ki vsebujejo folkodin, v Franciji v teh dveh obdobjih.
English: In France, data from spontaneous reporting suggests a 25% increase in the number of anaphylactic shocks to NMBAs in the period 2008/2009 when compared to the 2003/2004 period.
Slovenian: V Franciji podatki iz spontanih poročil nakazujejo 25-odstotno povečanje števila anafilaktičnih šokov zaradi živčno-mišičnih blokatorjev v obdobju 2008/2009 v primerjavi z obdobjem 2003/2004.
English: As a consequence, the French Medicines Agency changed the prescription status of pholcodine-containing medicines to prescription only and triggered this referral.
Slovenian: Posledično je francoska agencija za zdravila spremenila status izdajanja zdravil, ki vsebujejo folkodin, na zdravila, ki se izdajajo le na recept, in sprožila ta napotitveni postopek.
English: In countries with small populations such as Norway (4.8 million) and Sweden (9.3 million), confounding factors such as a change in anaesthetic procedures, type of products used in anaesthesia and overall use of NMBAs could play a role in explaining the findings.
Slovenian: V državah z majhnim številom prebivalcev, kot sta Norveška (4,8 milijona) in Švedska (9,3 milijona), lahko morda sočasni dejavniki, kot so spremenjeni anestezijski postopki, vrsta zdravila, uporabljenega za anestezijo, in splošna uporaba živčno-mišičnih blokatorjev, pomagajo razložiti te izsledke.
English: pholcodine was withdrawn, the severity of the reactions reported has not changed.
Slovenian: od umika folkodina resnost reakcij, o katerih so poročali, ni spremenila.
English: For this purpose, Marketing Authorisation Holders shall conduct a case-control study as described in annex III of this opinion.
Slovenian: Zato bo imetnik dovoljenja za promet z zdravilom opravil študijo „s kontrolno skupino“, kot je opisano v prilogi III tega mnenja.
English: Therefore investigating pholcodine exposure prior to anaesthesia is currently not done and it would likely be a complicated process, as the majority of patients either will not know or will not remember that they have taken it.
Slovenian: Zato se raziskave o izpostavljenosti folkodinu pred anestezijo trenutno ne opravljajo, saj bi bil to verjetno zapleten postopek, ker večina bolnikov ne ve, ali so to zdravilo uporabili, ali se pa tega ne spomni.
English: This study has limitations such as a lack of a placebo control arm and the non-validated and subjective nature of the outcomes (cough frequency and intensity), but an effect was observed very early in the treatment.
Slovenian: Ta študija ima omejitve, kot je odsotnost kontrolne skupine, nadzirane s placebom, ter nepotrjen in subjektiven značaj izidov (pogostnost in intenzivnost kašlja), vendar so v zelo zgodnjem obdobju zdravljenja opazili učinek.
English: The CHMP was requested to give its opinion on whether the marketing authorisations for medicinal products containing pholcodine-containing medicinal products should be maintained, varied, suspended or withdrawn.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je bil naprošen, naj izda mnenje o tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo folkodin, ohranijo, spremenijo, začasno prekličejo ali umaknejo.
English: The conditions affecting the marketing authorisations are set out in Annex III.
Slovenian: Pogoji, ki vplivajo na dovoljenje za promet z zdravilom, so navedeni v prilogi III.
English: This could explain the reason why data from countries such as the USA or the Netherlands does not fit with the pholcodine hypothesis: in these countries pholcodine is not marketed, and still prevalence of IgE to pholcodine and morphine was found to be high.
Slovenian: To lahko pojasni vzrok, zakaj se podatki iz držav, kot sta ZDA ali Nizozemska, ne ujemajo s hipotezo o folkodinu: čeprav v teh državah folkodin ni na trgu, je prevalenca IgE proti folkodinu in morfinu velika.
English: Most studies were not adequately controlled, either with active or placebo medications, and some were performed using combination products, which makes it difficult to isolate and measure the efficacy of the single component pholcodine.
Slovenian: Večina študij ni bila ustrezno nadzirana z zdravilnimi učinkovinami ali s placebom, nekatere pa so opravili s kombiniranimi zdravili, zaradi česar je učinkovitost folkodina kot samostojne sestavine težko izolirati in izmeriti.
English: In recent years the Norwegian network for anaphylaxis under general anaesthesia, which collects these reports, has been subject to less intense promotion, and therefore it is possible that the observed decrease in reporting does not actually reflect lower occurrence.
Slovenian: V zadnjih letih se je delovanje norveške mreže za anafilaksijo pod splošno anestezijo, ki ta poročila zbira, manj spodbujalo, zato je mogoče, da opaženo zmanjšanje poročanja ne odraža dejanske manjše pojavnosti.
English: Apr; 65 (4): 498-502.
Slovenian: Allergy 2010 Apr; 65 (4): 498-502.
English: There has been extensive use of pholcodine-containing products over the course of several decades, which has allowed the collection of relevant safety data.
Slovenian: Uporaba zdravil, ki vsebujejo folkodin, je razširjena že več desetletij, zato je bilo mogoče zbrati ustrezne podatke o varnosti.
English: Overall summary of the scientific evaluation of pholcodine-containing products (see Annex I) Background information
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo folkodin (glejte Prilogo I)
English: In a real-life situation where specialists are unable to take this factor into account in clinical practice, investigation of the pholcodine exposure in individual patients prior to anaesthesia is not considered to be of benefit as it will not change anaesthetic practice.
Slovenian: V dejanskih okoliščinah, kadar specialisti v klinični praksi ne morejo upoštevati tega dejavnika, se raziskava o izpostavljenosti posameznih bolnikov folkodinu pred anestezijo ne obravnava kot koristna in ne spremeni anestezijske prakse.
English: Pholcodine is an opiate with central antitussive action used for treatment of cough and cold symptoms in children and adults.
Slovenian: Folkodin je opiat z osrednjim delovanjem proti kašlju, ki se uporablja za zdravljenje kašlja in simptomov prehlada pri otrocih in odraslih.
English: 1 Johansson SGO et al. National pholcodine consumption and the prevalence of IgE-sensitisation; a multicenter study.
Slovenian: Johansson SGO in dr. National pholcodine consumption and the prevalence of IgE-sensitisation; a multicenter study.
English: The first clinical studies on efficacy of pholcodine as an antitussive agent are dated 1950.
Slovenian: Prve klinične študije o učinkovitosti folkodina kot sredstva proti kašlju so bile opravljene leta 1950.
English: To support this opinion, some experts referred to the data from the USA showing that there is sensitisation even in the absence of pholcodine consumption, which strengthens the view that other substances are able to trigger this kind of cross-sensitisation.
Slovenian: V podporo temu mnenju so se nekateri strokovnjaki sklicevali na podatke iz ZDA, po katerih je senzibilizacija nastopila tudi brez uporabe folkodina, kar podpira mnenje, da lahko tovrstno navzkrižno senzibilizacijo sprožijo tudi druge snovi.
English: If indeed other substances containing quaternary ammonium ions have the ability to induce cross-sensitisation to NMBAs, and if such substances can be found in numerous household products, the specificity of IgE to pholcodine has to be questioned.
Slovenian: Če so na primer tudi druge snovi, ki vsebujejo kvartarne amonijeve ione, sposobne povzročiti navzkrižno senzibilizacijo za živčno-mišične blokatorje in če so te snovi prisotne v številnih gospodinjskih predmetih, je treba specifičnost IgE za folkodin postaviti pod vprašaj.
English: The concerns of the French Medicines Agency arose from the potential risk that pholcodine may lead to IgEsensitisation to neuromuscular blocking agents (NMBAs).
Slovenian: Pomisleki francoske agencije za zdravila so izvirali iz možnega tveganja, da lahko folkodin povzroči IgE-senzibilizacijo (preobčutljivost) za živčno-mišične blokatorje (NMBA).
English: A further issue for consideration is that anaphylactic reactions to pholcodine itself appear to be rare.
Slovenian: Nadaljnji razlog za premislek je, da kaže, da so anafilaktične reakcije na folkodin redke.
English: There is a large body of literature demonstrating the existence of centrally-acting cough suppressant properties of opiates, and pholcodine in particular has been used in this indication since the 1950's.
Slovenian: Številna literatura kaže na osrednje delovanje opiatov proti kašlju, pri čemer se je za to indikacijo od petdesetih let prejšnjega stoletja uporabljal zlasti folkodin.
English: Class II and III reactions still represent the majority of the reported cases, same as when pholcodine was still marketed.
Slovenian: O reakcijah razreda II in III se še vedno poroča v večini primerov, kar se ni spremenilo od takrat, ko je bil folkodin še na trgu.
English: The majority of the experts considered that although sensitisation to pholcodine and development of allergic reactions to NMBAs is a possibility, the existing evidence is weak mainly due to inconsistencies and methodological bias.
Slovenian: Večina strokovnjakov je menila, da so kljub možni senzibilizaciji za folkodin in razvoj alergijskih reakcij na živčno-mišične blokatorje obstoječi dokazi prešibki zlasti zaradi nedoslednosti in metodološke pristranskosti.
English: The most recent study conducted by Zambon and published in 2006, comparing pholcodine and dextrometorphan in a randomised and blinded design, showed they had similar efficacy in reducing day and night-time cough frequencies in adult patients suffering with acute non-productive cough.
Slovenian: Najnovejša študija, ki jo je izvedla družba Zambon in je bila objavljena leta 2006, v kateri so folkodin in dekstrometorfan primerjali v randomizirani in slepi obliki, je pokazala, da imata podoben učinek na zmanjšanje pogostnosti kašlja podnevi in ponoči pri bolnikih z akutnim neproduktivnim kašljem.
English: 3 Johansson SGO et al. Pholcodine caused anaphylaxis in Sweden 30 years ago.
Slovenian: Johansson SGO in dr. Pholcodine caused anaphylaxis in Sweden 30 years ago (Anafilaksija, ki jo je folkodin na Švedskem povzročil pred 30 leti).
English: The experts also considered that the decision to use a NMBA is based on clinical need and cannot be avoided, regardless of history of pholcodine use.
Slovenian: Strokovnjaki so menili tudi, da temelji odločitev za uporabo živčno-mišičnih blokatorjev na klinični potrebi in se ji ni mogoče izogniti, ne glede na uporabo folkodina v anamnezi bolnika.
English: The Committee also considered that data from clinical trials and extensive post marketing use has demonstrated the efficacy of pholcodine in the treatment of non productive cough.
Slovenian: Odbor meni tudi, da so podatki iz kliničnih preskušanj in izčrpna uporaba v obdobju trženja dokazali učinkovitost folkodina za zdravljenje neproduktivnega kašlja.
English: The Committee recommended the maintenance of the marketing authorisations for the medicinal products referred to in Annex I.
Slovenian: Odbor priporoča, da se dovoljenja za promet z zdravilom za zdravila, navedena v prilogi I, ohranijo.
English: The majority of the adverse events reported in clinical trials, literature and post-marketing experience are gastrointestinal disorders and psychiatric disorders, which are adverse events known and commonly reported with opiates.
Slovenian: Večina neželenih učinkov, o katerih poročajo v kliničnih preskušanjih, literaturi in iz izkušenj v obdobju trženja, so prebavne in psihiatrične motnje, kar so znani neželeni učinki, o katerih pri opiatih pogosto poročajo.
English: Annex II Scientific conclusions and grounds for the maintenance of the marketing authorisations presented by the EMA
Slovenian: Znanstveni zaključki in podlaga za ohranitev dovoljenj za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
English: Even assuming that there is some biological plausibility for the pholcodine-sensitisation and that the spontaneously reported cases reflect the actual prevalence of anaphylactic reactions during surgery, a broad range of other agents may also be responsible.
Slovenian: Tudi če predvidevamo določeno stopnjo biološke verodostojnosti za senzibilizacije za folkodin in upoštevamo, da primeri, o katerih so poročali spontano, kažejo na dejansko razširjenost anafilaktičnih reakcij med kirurškim posegom, je mogoče, da so prisotni še številni drugi dejavniki.
English: It is also noted that in Norway, although there is a lower number of anaphylaxis reports since
Slovenian: Opomniti je treba tudi, da se na Norveškem kljub manjšem številu poročil o anafilaksiji
English: Grounds for the maintenance of the marketing authorisations
Slovenian: Podlaga za spremembo dovoljenj za promet z zdravilom
English: The results support the efficacy of pholcodine in the treatment of acute non-productive cough.
Slovenian: Rezultati podpirajo učinkovitost folkodina za zdravljenje akutnega neproduktivnega kašlja.
English: In recent years, observations in Norway led one team of researchers to raise the possibility that high consumption of cough mixtures in these countries was related to increased prevalence of IgE antibodies to pholcodine, morphine and suxamethonium, and ultimately higher incidence of IgE-mediated anaphylactic reactions to NMBAs1,2
Slovenian: V zadnjih letih je skupina znanstvenikov na Norveškem na podlagi opažanj izpostavila možnost, da je povečana poraba kombiniranih zdravil proti kašlju v teh državah povezana z večjo prevalenco IgEprotiteles proti folkodinu, morfinu in suksametoniju ter končno z večjo pojavnostjo anafilaktičnih reakcij na živčno-mišične blokatorje, pri katerih posreduje IgE1,2.
English: Nevertheless, the existing data is consistent and supportive of the efficacy of pholcodine in the treatment of acute non-productive cough.
Slovenian: Vendar pa je obstoječa literatura dosledna in podpira učinkovitost folkodina pri zdravljenju akutnega neproduktivnega kašlja.
English: Based on immunological analyses determining the prevalence of antibodies to these active substances in different populations, and reporting rates for NMBA-related anaphylaxis during anaesthesia, researchers concluded that withdrawal of pholcodine from the market in Norway significantly lowered within 1-2 years levels of IgE and IgE antibodies to pholcodine and, within 3 years, the frequency of NMBA suspected anaphylaxis.
Slovenian: Na podlagi imunoloških analiz, v katerih ugotavljajo prevalenco protiteles proti tem zdravilnim učinkovinam pri različnih populacijah in poročajo o deležu anafilaksij, povezanih z živčno-mišičnimi blokatorji med anestezijo, so znanstveniki zaključili, da je umik folkodina z norveškega trga v enem do dveh letih pomembno znižal ravni IgE in IgE-protiteles proti folkodinu, v treh letih pa tudi pogostnost anafilaksije, za katero se sumi, da jo povzročajo živčno-mišični blokatorji.
English: The Committee reviewed the available data on the safety and efficacy of pholcodine, particularly the data in support of a link between pholcodine use and development of NMBA-related anaphylaxis.
Slovenian: Odbor je proučil podatke o varnosti in učinkovitosti folkodina, ki so na voljo, zlasti podatke, ki podpirajo povezavo med uporabo folkodina in pojavom anafilaksije, povezane z živčno-mišičnimi blokatorji.
English: The existent data seems to indicate that pholcodine is at least as safe as codeine, with the advantage that it does not share the same potential for addiction.
Slovenian: Obstoječi podatki nakazujejo, da je folkodin najmanj varen v obliki kodeina, pri čemer je prednost, da je pri tej obliki možnost odvisnosti manjša.
English: Other experts questioned the specificity of the tests used by the Norwegian research team to detect IgE sensitisation to pholcodine, referred to the lack of a rigorous inclusion criterion for anaphylaxis (ie permitting cases undergoing spontaneous recovery, or a 'mild' presentation) in the investigations, and reference was also made to the use of spontaneously reported adverse events to determine incidence of NMBA-related anaphylaxis.
Slovenian: Drugi strokovnjaki dvomijo o specifičnosti preskusov, ki jih je za odkrivanje senzibilizacije IgE za folkodin uporabila norveška raziskovalna skupina, in navajajo pomanjkanje strogih vključitvenih kriterijev za anafilaksijo (tj. vključevanje primerov s spontanim okrevanjem ali blago obliko) v raziskavah ter uporabo neželenih učinkov iz spontanih poročil za ugotavljanje anafilaksije, povezane z živčnomišičnimi blokatorji.