FrancophonIA/ELRC3.0 huggingface dataset:
English: • adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
Slovenian: • odrasli in otroci s „kronično odpovedjo ledvic“ (dolgotrajno napredujoče upadanje sposobnosti ledvic za pravilno delovanje);
English: In addition, one study conducted in the United States was not in line with EU recommendations for treatment of patients with myelodysplastic syndromes.
Slovenian: Poleg tega ena študija, izvedena v Združenih državah, ni bila v skladu s priporočili EU za zdravljenje bolnikov z mielodisplastičnimi sindromi.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/165563/2018 EMEA/H/C/000332
Slovenian: marec 2018 EMA/165563/2018 EMEA/H/C/000332
English: What is Aranesp?
Slovenian: Kaj je Aranesp?
English: The CHMP was of the opinion that changes to the study design of one study and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.
Slovenian: Odbor CHMP je menil, da se zaradi spremembe zasnove ene študije in izključitve velikega števila bolnikov iz analize rezultatov zastavljajo vprašanja glede veljavnosti podatkov.
English: • adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer not originating in the bone marrow).
Slovenian: • odrasli, ki prejemajo kemoterapijo za zdravljenje „nemieloičnega“ raka (raka, ki ne izvira iz kostnega mozga).
English: The medicine was to be used in patients who did not need frequent blood transfusions and who had a low or intermediate risk of their condition progressing to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells).
Slovenian: Zdravilo naj bi se uporabljalo pri bolnikih, ki ne potrebujejo pogoste transfuzije krvi in pri katerih je majhno ali srednje tveganje, da bo njihova bolezen napredovala v kronično mieloično levkemijo (AML, vrsta raka, ki prizadene bele krvničke).
English: The applicant presented data from two main studies in 356 anaemic patients with myelodysplastic syndromes.
Slovenian: Vlagatelj je predložil podatke iz dveh glavnih študij, v kateri je bilo vključenih 356 anemičnih bolnikov z mielodisplastičnimi sindromi.
English: In the second study, all patients received Aranesp for 13 weeks and the study measured the level of haemoglobin, the main constituent of red blood cells, in the blood.
Slovenian: V drugi študiji so vsi bolniki 13 tednov prejemali zdravilo Aranesp, merila pa se je raven hemoglobina, ki je glavna sestavina rdečih krvničk, v krvi.
English: It contains the active substance darbepoetin alfa.
Slovenian: Vsebuje zdravilno učinkovino darbepoetin alfa.
English: The first study compared Aranesp with placebo (a dummy treatment) over 24 weeks.
Slovenian: V prvi študiji so zdravilo Aranesp primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju 24 tednov.
English: On 21 February 2018, Amgen Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application to add treatment of anaemia in adult patients with myelodysplastic syndromes to the existing marketing authorisation.
Slovenian: je 21. februarja 2018 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dodatek zdravljenja anemije pri odraslih bolnikih z mielodisplastičnimi sindromi k obstoječemu dovoljenju za promet.
English: Aranesp is a medicine already used to treat anaemia (low red-blood-cell count) that is causing symptoms in the following groups of patients:
Slovenian: Aranesp je zdravilo, ki se že uporablja za zdravljenje anemije (majhno število rdečih krvničk), ki povzroča simptome pri naslednjih skupinah bolnikov:
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not considered to be reliable and the Committee concluded that the change to the use of the medicine could not have been approved based on the data presented by the company.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da rezultati študije niso zanesljivi, in sklenil, da spremembe uporabe zdravila na podlagi podatkov, ki jih je predložila družba, ni mogoče odobriti.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal is based on the CHMP's opinion that the data provided do not allow the Committee to authorise use in myelodysplastic syndromes.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umik temelji na mnenju odbora CHMP, da predstavljeni podatki odboru ne dovoljujejo odobritve uporabe pri mielodisplastičnih sindromih.
English: Aranesp, acts exactly like a natural hormone called erythropoietin that is made by the kidneys to stimulate red blood cell production, but it is very slightly different in its structure.
Slovenian: točno tako kot naravni hormon, imenovan eritropoetin, ki se tvori v ledvicah za spodbujanje nastajanja rdečih krvničk, vendar pa se po svoji strukturi le nekoliko razlikuje.
English: The company informed the Agency that there are no Amgen-sponsored ongoing clinical trials with Aranesp.
Slovenian: Družba Amgen je agencijo obvestila, da trenutno ne potekajo klinična preskušanja zdravila Aranesp, ki bi jih finančno podpirala.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aranesp could not have been approved for the treatment of anaemia in adult patients with myelodysplastic syndromes.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in začasno menil, da zdravila Aranesp ni mogoče odobriti za zdravljenje anemije pri odraslih bolnikih z mielodisplastičnimi sindromi.
English: What was Aranesp expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Aranesp uporabljalo?
English: Aranesp was also expected to be used to treat anaemia in patients with myelodysplastic syndromes, a group of bone marrow disorders.
Slovenian: Zdravilo Aranesp naj bi se uporabljalo tudi za zdravljenje anemije pri bolnikih z mielodisplastičnimi sindromi, tj. skupina bolezni kostnega mozga.
English: By acting in the same way as erythropoietin, Aranesp stimulates the body to make more red blood cells and so treats anaemia.
Slovenian: Zdravilo Aranesp, ki deluje enako kot eritropoetin, spodbuja telo, da tvori več rdečih krvničk in tako zdravi anemijo.
English: There are no consequences for the use of Aranesp in its authorised uses.
Slovenian: Umik vloge nima posledic za odobrene uporabe zdravila Aranesp.
English: How does Aranesp work?
Slovenian: Kako zdravilo Aranesp deluje?
English: In the treatment of anaemia in patients with myelodysplastic syndromes, Aranesp was expected to work in the same way as it does in its existing indications.
Slovenian: Zdravilo Aranesp naj bi pri zdravljenju anemije pri bolnikih z mielodisplastičnimi sindromi delovalo enako kot pri obstoječih indikacijah.
English: Darbepoetin alfa, the active substance in
Slovenian: Darbepoetin alfa, zdravilna učinkovina zdravila Aranesp, deluje
English: What is happening with Aranesp in its authorised uses?
Slovenian: Kakšne so posledice za odobrene uporabe zdravila Aranesp?
English: The timetable for the implementation of the agreement is set out in Annex IV.
Slovenian: Časovni razpored za izvajanje sporazuma je opredeljen v Prilogi IV.
English: The children's age ranged from 17 days to 6 years.
Slovenian: Starost otrok je bila od 17 dni do 6 let.
English: Therefore, this continues to represent a variable safety risk across all paediatric age groups.
Slovenian: To je zato še vedno sprejeto kot spremenljivo varnostno tveganje pri vseh pediatričnih starostnih skupinah.
English: A review of these cases indicated that, four cases had a fatal outcome.
Slovenian: Pri pregledu teh primerov je bilo ugotovljeno, da so se štirje od njih končali s smrtnim izidom.
English: In such clinical settings it is not expected that codeine use brings any significant benefit, while the risks identified can be of serious consequences.
Slovenian: V takih kliničnih okoliščinah ni pričakovati, da bo uporaba kodeina ponudila kakršne koli pomembne koristi, medtem ko ima lahko ugotovljeno tveganje resne posledice.
English: The remaining cases were all life-threatening but resulted in full recovery.
Slovenian: Vsi preostali primeri so bili smrtno nevarni, vendar je bilo okrevanje popolno.
English: Overall, the majority (38/50) of the cases were in patients younger than 12 years of age and 6 were fatal cases.
Slovenian: Na splošno je bila večina (38/50) teh primerov povezana z bolniki, mlajšimi od 12 let, od katerih jih je bilo šest smrtnih.
English: Data analyses from the Eudravigilance database identified a total of 50 case reports that could be related to opiate toxicity, of which 31 cases were in those younger than 6 years (including 4 fatal cases), 7 cases in older than 6 years and younger than 12 years (including 1 fatal case) and the remaining 12 cases were on those older than 12 and younger than 18 years (including 1 fatal case).
Slovenian: Analize podatkov iz podatkovne baze Eudravigilance so izpostavile skupno 50 poročil primerov, ki bi bili lahko povezani z opioidno toksičnostjo: 31 primerov pri otrocih, mlajših od 6 let (vključno s 4 smrtnimi primeri), 7 primerov pri otrocih, starejših od 6 let in mlajših od 12 let (vključno z 1 smrtnim primerom) in preostalih 12 primerov pri otrocih, starejših od 12 let in mlajših od 18 let (vključno z 1 smrtnim primerom).
English: Codeine is converted into morphine in the body by cytochrome P450 2D6 (CYP2D6), an enzyme which shows genetic polymorphism.
Slovenian: Kodein se v telesu pretvori v morfin prek citokroma P450 2D6 (CYP2D6), ki je encim, ki kaže genetski polimorfizem.
English: The symptoms of morphine toxicity may be increased in these settings.
Slovenian: V takih okoliščinah se lahko simptomi toksičnosti morfina okrepijo.
English: 2 American Academy of Pediatrics Committee on Drugs ‘Use of codeine- and dextromethorphan-containing cough remedies in children', Pediatrics 1997;99:918-20.
Slovenian: ‘Use of codeine- and dextromethorphan-containing cough remedies in children', Pediatrics 1997;99:918-20.
English: Codeine suppresses the cough reflex through a direct effect on the cough centre in the medulla.
Slovenian: Kodein zavira refleks kašlja z neposrednim učinkom na center za kašelj v meduli.
English: Apart from its use as an analgesic for relief of pain, it is also used for the symptomatic treatment of cough and/or cold.
Slovenian: Poleg njegove uporabe kot analgetika za lajšanje bolečine se uporablja tudi za simptomatsko zdravljenje kašlja in/ali prehlada.
English: The PRAC also considered data from the European Pharmacovigilance database (Eudravigilance), a drug utilisation study of the patterns of prescription of codeine and performed a consultation with European healthcare professional organisations and with the Paediatric Committee (PDCO).
Slovenian: Upošteval je tudi podatke iz evropske farmakovigilančne podatkovne baze (Eudravigilance) in študije uporabe zdravil, ki je proučevala vzorce predpisovanja kodeina, ter se posvetoval z evropskimi organizacijami zdravstvenih delavcev in Pediatričnim odborom (PDCO).
English: A review of serious and fatal cases in paediatric patients from the literature, global pharmacovigilance databases and regulatory authorities suggests that the respiratory depressant effects of codeine may influence the occurrence of respiratory complications.
Slovenian: Pregled resnih in smrtnih primerov pri pediatričnih bolnikih na podlagi literature, globalnih farmakovigilančnih podatkovnih baz in regulativnih organov kaže, da lahko učinki kodeina na respiratorno depresijo vplivajo na pojavnost respiratornih zapletov.
English: However, there is little clinical data in the medical literature to support the efficacy of codeine in the
Slovenian: Vendar je v medicinski literaturi malo kliničnih podatkov, ki podpirajo učinkovitost kodeina pri simptomatskem
English: In addition, the CMDh considered that a minor change was necessary to the wording proposed in Sections 4.2 and 4.6 of the Summary of Product Characteristics (SmPC) and Section 2 of the Package Leaflet (PL), in order to facilitate the practical implementation at the National level, taking into account the range of combination products included in the procedure.
Slovenian: Poleg tega je skupina CMDh menila, da je potrebna majhna sprememba besedila, predlaganega v poglavjih 4.2 in 4.6 povzetka glavnih značilnosti zdravila in poglavju 2 navodila za uporabo, da se olajša praktična izvedba na nacionalni ravni, upoštevajoč razpon kombiniranih zdravil, vključenih v postopek.
English: Therefore, the marketing authorisation holders of codeine containing medicinal products in oral formulations should discuss with the National Competent Authorities in the Member States the applicability of this minimisation measure in their territory.
Slovenian: Imetniki dovoljenj za promet z zdravili v peroralnih formulacijah, ki vsebujejo kodein, se morajo posvetovati z nacionalnimi zadevnimi organi v državah članicah glede veljavnosti tega ukrepa za zmanjševanje tveganja v svoji državi.
English: Cough is a reflex response to mechanical, chemical, or inflammatory irritation of the tracheobronchial tree.
Slovenian: Kašelj je refleksni odziv na mehansko, kemično ali vnetno draženje traheobronhialnega drevesa.
English: Efficacy data is therefore limited, with no recent and well-established controlled scientific studies to clearly support the benefit of codeine in the approved indications for cough and/or cold for the paediatric population.
Slovenian: Podatki o učinkovitosti so zato omejeni, saj ni novih in dobro podprtih nadzorovanih znanstvenih študij, ki bi jasno podprle korist kodeina pri odobrenih indikacijah kašlja in/ali prehlada pri pediatrični populaciji.
English: The PRAC also noted that cough associated with upper respiratory tract infections is the dominating cause of cough in children.
Slovenian: Prav tako je izpostavil, da je kašelj, povezan z okužbami zgornjih dihal, prevladujoči vzrok kašlja pri otrocih.
English: Treatment guidelines recommend treatment of persistent chronic cough in paediatric patients based on aetiology.
Slovenian: Smernice za zdravljenje priporočajo, da zdravljenje persistentnega kroničnega kašlja pri pediatričnih bolnikih temelji na etiologiji;
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Slovenian: 2 - Podrobna obrazložitev znanstvene podlage za odstopanja od priporočila PRAC
English: The large majority of childhood respiratory infections with cough are caused by viral infections, which are self-limiting and only last for a few days whereas in the case of chronic cough, treatment should be directed at the underlying disease2,3 (American Academy of Paediatrics Committee on Drugs 1997, American Academy of Paediatrics, AAP publications retired or reaffirmed 2006).
Slovenian: Veliko večino otroških okužb dihal s kašljem povzročajo virusne okužbe, ki so samoomejujoče in trajajo samo nekaj dni, medtem ko je treba pri kroničnem kašlju zdravljenje osredotočiti na osnovno bolezen2, 3 (Odbor za zdravila pri Ameriški akademiji za pediatrijo 1997, Ameriška akademija za pediatrijo, umaknjene ali znova potrjene publikacije AAP 2006).
English: This included MAH responses, published literature data which became available since the initial granting of the marketing authorisations and consultation of healthcare professionals and other experts.
Slovenian: Mednje spadajo odgovori imetnikov dovoljenj za promet z zdravili, podatki iz objavljene literature, ki so postali na voljo po začetni odobritvi dovoljenj za promet z zdravili, in posveti med zdravstvenimi delavci ter drugimi strokovnjaki;
English: Codeine, also known as methylmorphine, binds to µ-opioid receptors to produce analgesia and euphoria, as well as respiratory depression, miosis, and reduced gastric motility.
Slovenian: Kodein, imenovan tudi metilmorfin, se veže na µ-opioidne receptorje in povzroča analgezijo ter evforijo, sočasno pa tudi respiratorno depresijo, miozo in zmanjšano motiliteto želodca.
English: Overall conclusion and grounds for the variation to the terms of the marketing authorisations Whereas
Slovenian: Splošni zaključek in podlaga za spremembo pogojev dovoljenj za promet z zdravilom Ob upoštevanju naslednjega:
English: 1 Article 31 pharmacovigilance referral for codeine used for management of pain in paediatric patients (EMA/H/A-31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f symptomatic treatment of cough and/or cold as current evidence does not find codeine to be more effective than placebo for acute cough in children.
Slovenian: 1 Farmakovigilančni napotitveni postopek v skladu s členom 31 za kodein, ki se uporablja za obvladovanje bolečine pri pediatričnih bolnikih (EMA/H/A-31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f zdravljenju kašlja in/ali prehlada, saj trenutni dokazi ne kažejo, da bi bil ta učinkovitejši proti akutnem kašlju pri otrocih kot placebo.
English: The present referral under Article 31 of Directive 2001/83/EC concerns the use of codeine in paediatric patients for the cough and/or cold indications as triggered on 02 April 2014 by the German National Competent Authority (BfArM) due to the applicability of the above risk measures also to these indications.
Slovenian: Trenutni napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, ki vključuje uporabo kodeina pri pediatričnih bolnikih za indikaciji kašlja in/ali prehlada, je 2. aprila 2014 sprožil nemški nacionalni zadevni organ (BfArM) zaradi veljavnosti zgornjih ukrepov za zmanjševanje tveganja tudi pri teh indikacijah.
English: Therefore, whenever reference to codeine is made in these SmPC sections and the product is a combination of codeine and other active substances, the wording is amended to include the invented name of these products instead of the INN “codeine”.
Slovenian: Kadar se v teh poglavjih povzetka glavnih značilnosti zdravila pojavi sklic na kodein in je zdravilo kombinacija kodeina ter drugih zdravilnih učinkovin, se besedilo spremeni, tako da vključuje izmišljeno ime teh zdravil namesto imena INN „kodein“.
English: The unpredictable and variable metabolism of codeine in children, governed by CYP2D6 polymorphism, may cause some children to exhibit morphine-related serious adverse events such as breathing difficulties or respiratory depression even within the recommended doses.
Slovenian: Nepredvidljiva in spremenljiva presnova kodeina pri otrocih, ki jo nadzoruje polimorfizem CYP2D6, lahko pri nekaterih otrocih povzroči z morfinom povezane resne neželene dogodke, kot so težave z dihanjem ali respiratorna depresija, celo ob priporočenih odmerkih.
English: Overall, only four published studies investigating the use of codeine-containing medicines for the treatment of cough in children could be identified.
Slovenian: Skupno so odkrili samo štiri objavljene študije, ki so proučevale uporabo zdravil, ki vsebujejo kodein, za zdravljenje kašlja pri otrocih.
English: The PRAC reviewed all available data from different sources: clinical trials, observational studies, metaanalyses, post-marketing data and further published literature data on the use of codeine containing products in children for treatment of cough and/or cold.
Slovenian: Odbor PRAC je pregledal vse razpoložljive podatke iz različnih virov: kliničnih preskušanj, opazovalnih študij, metaanaliz, podatkov iz obdobja trženja in dodatnih podatkov iz objavljene literature glede uporabe zdravil, ki vsebujejo kodein, za zdravljenje kašlja in/ali prehlada pri otrocih.
English: Therefore, the PRAC suggests that National Competent Authorities of the EU Members States to take the necessary actions to have the labelling of codeine products approved only for adults updated with the contraindications.
Slovenian: Odbor zato priporoča, da nacionalni zadevni organi v državah članicah EU uvedejo potrebne ukrepe, da bo označevanje zdravil s kodeinom, odobrenih samo za odrasle, posodobljeno s kontraindikacijami.
English: Individuals are normally classified as poor (PM), extensive (EM) or ultrarapid metabolisers (UM), depending on the activity of the enzyme.
Slovenian: Posamezniki se navadno razvrstijo kot osebe z upočasnjeno presnovo (PM), obsežno presnovo (EM) ali izredno hitro presnovo (UM), kar je odvisno od dejavnosti encima.
English: However, the CMDh considered that in view of the recommended contra indication of the use of codeine for cough and/or cold in children below 12 years of age, some marketing authorisations may have to be revoked.
Slovenian: Vendar je menila, da bo morda treba zaradi priporočene kontraindikacije za uporabo kodeina proti kašlju in/ali prehladu pri otrocih, mlajših od 12 let, preklicati nekatera dovoljenja za promet z zdravili.
English: In addition, the PRAC also recommended that the relevant risk minimisation measures from the previous referral should also apply to the use of codeine in the symptomatic treatment of cough and/or cold.
Slovenian: Poleg tega je priporočil, da morajo zadevni ukrepi za zmanjševanje tveganja iz prejšnjega napotitvenega postopka veljati tudi za uporabo kodeina pri simptomatskem zdravljenju kašlja in/ali prehlada.
English: • The PRAC considered available data on the safety and the efficacy of the codeine containing medicinal products for the treatment of cough and/or cold in children in relation to the risk of opioid toxicity.
Slovenian: • odbor PRAC je pretehtal razpoložljive podatke o varnosti in učinkovitosti zdravil, ki vsebujejo kodein, za zdravljenje kašlja in/ali prehlada pri otrocih v povezavi s tveganjem opioidne toksičnosti.
English: The PRAC also considered that the use of codeine in pain relief could be associated with serious adverse events of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine, in particular in the paediatric population below 12 years of age and therefore codeine should not be used in this population.
Slovenian: Poleg tega je upošteval, da je lahko uporaba kodeina za lajšanje bolečine povezana z resnimi neželenimi dogodki opioidne toksičnosti zaradi spremenljive in nepredvidljive presnove kodeina v morfin, predvsem pri pediatrični populaciji, mlajši od 12 let, zato se pri tej populaciji ne sme uporabljati.
English: Further to consideration of all data available at that time, the PRAC concluded that codeine remained an effective analgesic for the treatment of acute moderate pain in children above 12 years of age which is not considered to be relieved by other analgesics.
Slovenian: Ko je odbor PRAC pretehtal vse podatke, ki so bili takrat na voljo, je zaključil, da je kodein še vedno učinkovit analgetik za zdravljenje zmerne akutne bolečine, ki je ni mogoče ublažiti z drugimi analgetiki, pri otrocih, starejših od 12 let.
English: All codeine containing medicinal products approved for the treatment of cough and/or cold in paediatric population, including single and combination products authorised in the European Union are included in this review.
Slovenian: V ta pregled so vključena vsa zdravila, ki vsebujejo kodein in so odobrena za zdravljenje kašlja in/ali prehlada pri pediatrični populaciji, vključno s posameznimi in kombiniranimi zdravili, odobrenimi v Evropski uniji.