FrancophonIA/ELRC3.0 huggingface dataset:
English: The review looked at data from several studies including:
Slovenian: V pregled so bili vključeni podatki iz več študij, med drugim:
English: The review of adrenaline auto-injectors was initiated at the request of the United Kingdom in April 2014, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled samoinjektorjev adrenalina se je začel aprila 2014 na zahtevo Združenega kraljestva v skladu s členom 31 Direktive 2001/83/ES.
English: • If you have any question or concern, speak with your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja ali pomisleke, se posvetujte z zdravnikom ali farmacevtom.
English: Adrenaline auto-injectors have been approved through national procedures in all the EU Member States.
Slovenian: Samoinjektorji adrenalina so bili z nacionalnimi postopki odobreni v vseh državah članicah EU.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's final opinion.
Slovenian: Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), pristojen za vprašanja, povezana z zdravili za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
English: This supports the introduction of proper training and comprehensive educational material for patients and healthcare professionals.
Slovenian: To podpira uvedbo ustreznega usposabljanja in obsežnega izobraževalnega materiala za bolnike in zdravstvene delavce.
English: Contact our press officer Monika Benstetter
Slovenian: Monika Benstetter
English: • Several factors may affect whether adrenaline reaches the muscle layer.
Slovenian: • Mnogi dejavniki lahko vplivajo na to, ali adrenalin doseže mišično plast.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 14/08/2015.
Slovenian: Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 14. 08. 2015 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: On 25 June 2015, the European Medicines Agency (EMA) recommended several measures, including the introduction of more effective educational material, to ensure that patients and carers use adrenaline auto-injectors successfully.
Slovenian: Evropska agencija za zdravila (EMA) je 25. junija 2015 priporočila več ukrepov, vključno z uvedbo učinkovitejšega izobraževalnega materiala, ki bodo zagotovili, da bodo bolniki in negovalci uspešno uporabljali samoinjektorje adrenalina.
English: This followed a national review of all adrenaline autoinjector products approved in the UK, which concluded that there was no robust evidence that the devices deliver adrenaline into a muscle for all patients.
Slovenian: To je bila posledica nacionalnega pregleda vseh samoinjektorjev adrenalina, odobrenih v Združenem kraljestvu, pri katerem so ugotovili, da ni trdnih dokazov, da ti pripomočki dovajajo adrenalin v mišico pri vseh bolnikih.
English: • It is important that you use the auto-injector correctly so that the adrenaline is delivered into your muscle and works as quickly as possible.
Slovenian: • Pomembno je, da samoinjektor uporabljate pravilno, tako da se adrenalin dovaja v mišico in začne delovati čim prej.
English: The CHMP recommendation was sent to the European Commission which endorsed it and issued a legally binding decision that is valid throughout the EU.
Slovenian: Priporočilo CHMP je bilo poslano Evropski komisiji, ki ga je potrdila in izdala pravno zavezujočo odločbo, ki velja za celotno Evropsko unijo (EU).
English: • It is likely that your doctor will recommend that you carry 2 injectors, in case a second dose is needed while you wait for emergency assistance.
Slovenian: • Zdravnik bo verjetno priporočil, da imate pri sebi 2 injektorja, če boste morda potrebovali drugi odmerek, medtem ko čakate na nujno zdravniško pomoč.
English: • Your family members, carers or teachers should also be instructed in the correct use of the autoinjector.
Slovenian: • Družinskim članom, negovalcem in učiteljem je prav tako treba dati navodila za pravilno uporabo samoinjektorja.
English: • If you have been prescribed an adrenaline auto-injector because you are at risk of severe allergic reactions, you should ensure you are familiar with it and carry it with you at all times.
Slovenian: • Če ste dobili recept za samoinjektor adrenalina, ker ste izpostavljeni tveganju hudih alergijskih reakcij, morate zagotoviti, da ste seznanjeni z njim in ga imate ves čas pri sebi.
English: • A study in 2013 by Brown et al. showed that 15% of the mothers were unable to use the autoinjector successfully in their children.
Slovenian: so v svoji študiji leta 2013 pokazali, da 15 % mater ni zmoglo uspešno uporabiti samoinjektorja pri svojih otrocih.
English: A training device will also be developed so that you can practise with it before you need the autoinjector in an emergency.
Slovenian: Prav tako bodo razvili pripomoček, s katerim boste lahko vadili, preden boste potrebovali samoinjektor v nujnem primeru.
English: Anaphylaxis is a life-threatening reaction that causes a drop in blood pressure and breathing difficulties.
Slovenian: Anafilaksija je smrtno nevarna reakcija, ki povzroči padec krvnega tlaka in težave z dihanjem.
English: A training video will be produced to show you in detail how to use the injector properly.
Slovenian: Izdelali bodo tudi video za usposabljanje, ki vam bo podrobno prikazal pravilno uporabo injektorja.
English: The product information of adrenaline auto-injectors has also been updated with further warnings and precautions, including a recommendation that patients should be prescribed two auto-injectors which they should carry at all times and a recommendation for family members, carers or teachers to be trained on how to use the auto-injector.
Slovenian: Tudi informacije o zdravilu za samoinjektorje adrenalina so bile posodobljene z dodatnimi opozorili in previdnostnimi ukrepi, vključno s priporočilom, naj se bolniku predpišeta dva samoinjektorja, ki ju mora imeti pri sebi ves čas, in priporočilom za družinske člane, negovalce ali učitelje, naj se usposobijo za uporabo samoinjektorja.
English: EMA carried out a review of adrenaline auto-injectors following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, and this may delay response to treatment.
Slovenian: Agencija EMA je izvedla pregled samoinjektorjev adrenalina, ko so se pojavili pomisleki, da lahko trenutno razpoložljivi pripomočki dovajajo adrenalin pod kožo namesto v mišico, kar lahko upočasni odziv na zdravljenje.
English: Training device and audio-visual material expected to promote appropriate use of auto-injectors
Slovenian: Pripomoček za usposabljanje in avdiovizualni material za spodbujanje pravilne uporabe samoinjektorjev
English: This will include a training device that patients can practise with, audiovisual material and a prescriber checklist.
Slovenian: To bo vključevalo pripomoček za usposabljanje, s katerim lahko bolniki vadijo, avdiovizualni material in kontrolni seznam za predpisovalce.
English: • Because of the uncertainties over drug delivery from adrenaline auto-injectors and the consequent uncertainties around the onset of pharmacodynamic response, it is recommended that healthcare professionals prescribe 2 auto-injectors, which patients should carry at all times.
Slovenian: • Zaradi negotovosti pri dovajanju zdravila s samoinjektorji adrenalina in posledičnih negotovosti glede nastopa farmakodinamičnega odziva je priporočljivo, da zdravstveni delavci predpišejo 2 samoinjektorja, ki ju mora imeti bolnik ves čas pri sebi.
English: This includes a training device with which patients can practise; audio-visual material to show in detail how the device is to be used; and a checklist for prescribers to ensure that sufficient information is given to the patient before they use the auto-injector.
Slovenian: To vključuje pripomoček za usposabljanje, s katerim lahko bolniki vadijo, avdiovizualni material, ki podrobno prikazuje, kako je treba uporabljati pripomoček, in kontrolni seznam za predpisovalce, ki zagotavlja, da bolnik pred uporabo samoinjektorja prejme zadostne informacije.
English: Having assessed all the available data, EMA's Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis.
Slovenian: Po pregledu vseh razpoložljivih podatkov je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji potrdil, da je injiciranje zdravila v mišico prednostni način za doseganje hitrega odziva pri anafilaksiji.
English: Better training tools to support patients using adrenaline auto-injectors
Slovenian: Boljša orodja za usposabljanje bolnikov, ki uporabljajo samoinjektorje adrenalina
English: An injection of adrenaline helps to relieve the symptoms of anaphylaxis quickly by narrowing the blood vessels (thereby increasing the blood pressure) and opening up the airways to help with the breathing.
Slovenian: Injiciranje adrenalina hitro pomaga olajšati simptome anafilaksije, tako da zoži krvne žile (in s tem poviša krvni tlak) ter odpre dihalne poti, kar olajša dihanje.
English: • Educational material will be developed to ensure that patients or carers use adrenaline autoinjectors successfully.
Slovenian: • Razvili bodo izobraževalni material, ki bo zagotavljal, da bodo bolniki ali negovalci uspešno uporabljali samoinjektorje adrenalina.
English: The CHMP also concluded that further data should be generated to better understand how adrenaline penetrates body tissues when given with each of the different auto-injectors.
Slovenian: Odbor CHMP je prav tako sklenil, da je treba pridobiti dodatne podatke, ki bi nadalje pojasnili, kako adrenalin prodre v telesna tkiva, kadar se daje s posameznimi različnimi samoinjektorji.
English: • The companies that market adrenaline auto-injectors have been asked to carry out a pharmacokinetic/pharmacodynamic study to better understand how adrenaline penetrates body tissues when given through an auto-injector.
Slovenian: • Družbe, ki tržijo samoinjektorje adrenalina, so prosili, naj izvedejo farmakokinetično/farmakodinamično študijo, ki bo izboljšala razumevanje, kako adrenalin prodira v telesna tkiva, kadar se daje s samoinjektorjem.
English: However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.
Slovenian: Vendar pa je odbor CHMP ugotovil, da lahko na dejansko dovajanje adrenalina v mišico vpliva več dejavnikov, ki vključujejo dolžino igle, debelino maščobe pod kožo, način delovanja samoinjektorja (npr. če je vzmeten ali ne), kot, pod katerim se pripomoček namesti na kožo in sila, ki se uporabi za aktivacijo pripomočka, pa tudi stopnja uporabnikovega upoštevanja navodil za injiciranje.
English: These include: needle length, the skin-to-muscle depth, the way the auto-injector works (e.g. if it is spring loaded or not), the angle of placement on the skin and the force used to activate the device.
Slovenian: Ti vključujejo dolžino igle, globino od kožo do mišice, način delovanja samoinjektorja (npr. ali je vzmeten ali ne), kot namestitve na kožo in silo, ki se uporabi za aktivacijo pripomočka.
English: • Adrenaline auto-injectors are used to treat severe allergic reactions, while the patient awaits emergency medical assistance.
Slovenian: • Samoinjektorji adrenalina se uporabljajo za zdravljenje hudih alergijskih reakcij, medtem ko bolniki čakajo na nujno zdravniško pomoč.
English: They are designed so that they can be easily used by the patient themselves or a carer.
Slovenian: Njihova zasnova bolniku ali negovalcu omogoča preprosto uporabo.
English: • The review of adrenaline auto-injectors showed that patients could benefit from further training to use the auto-injector successfully.
Slovenian: • Pregled samoinjektorjev adrenalina je pokazal, da bi bolnikom koristilo dodatno usposabljanje za uspešno uporabo samoinjektorja.
English: Adrenaline (epinephrine) auto-injectors are given to people who are at risk of anaphylaxis (severe allergic reaction) or have had a previous episode of anaphylaxis, to use as a first-aid measure in case of emergencies while waiting for emergency medical assistance.
Slovenian: Samoinjektorji adrenalina (epinefrina) se predpisujejo osebam, ki so izpostavljene tveganju anafilaksije (hude alergijske reakcije) ali ki so že imele epizodo anafilaksije, kot prva pomoč v nujnih primerih, medtem ko bolnik čaka na nujno zdravniško pomoč.
English: • The review of adrenaline auto-injectors confirmed that intramuscular injection is the preferred route of administration in the treatment of anaphylaxis in order to obtain a rapid response.
Slovenian: • S pregledom samoinjektorjev adrenalina so potrdili, da je intramuskularno injiciranje prednostna pot uporabe pri zdravljenju anafilaksije, ki omogoča hiter odziv.
English: • You will receive training from your doctor or nurse on how to use your adrenaline auto-injector.
Slovenian: • Zdravnik ali medicinska sestra vas bosta usposobila za uporabo samoinjektorja adrenalina.
English: The companies that market adrenaline auto-injectors have therefore been asked to develop more effective educational material for patients, as well as for healthcare professionals, to ensure their optimal use.
Slovenian: Odbor CHMP je sklenil, da je usposabljanje uporabnika izjemno pomembno, zato je od družb, ki tržijo samoinjektorje adrenalina, zahteval, naj razvijejo učinkovitejši izobraževalni material za bolnike in zdravstvene delavce, s čimer bodo zagotovili njihovo optimalno uporabo.
English: Adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance.
Slovenian: Samoinjektorji adrenalina lahko rešijo življenje v primerih anafilaksije (hude alergijske reakcije), medtem ko bolniki čakajo na nujno medicinsko pomoč.
English: Onsenal has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Onsenal je bilo odobreno v „izjemnih okoliščinah“.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Onsenal.
Slovenian: To pomeni, da zaradi redkosti bolezni še ni bilo mogoče dobiti vseh podatkov o zdravilu Onsenal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onsenal on 17 October 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Onsenal, veljavno po vsej Evropski uniji, odobrila dne 17. oktobra 2003.
English: The company will submit a progress report on the study, including all safety information and details of how it is ensuring that patients are being recruited quickly enough.
Slovenian: Družba bo predložila tudi poročilo o napredku študije, vključno z vsemi informacijami o varnosti in podrobnostmi o tem, kako bo zagotovila, da bodo bolniki dovolj hitro izbrani za sodelovanje v študiji.
English: The company will also submit a full report on the study
Slovenian: Po zaključku študije bo predložila tudi celotno poročilo o opravljeni študiji.
English: Onsenal at a dose of 400 mg twice a day was more effective than placebo.
Slovenian: Zdravilo Onsenal v odmerku 400 mg dvakrat dnevno je bilo učinkovitejše od placeba.
English: What benefit has Onsenal shown during the studies?
Slovenian: Kakšne koristi je zdravilo Onsenal izkazalo med študijami?
English: The main measure of effectiveness was the reduction in the number of polyps in a defined area of the colon or rectum wall after six months of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje števila polipov v določenem predelu kolona ali danke po šestih mesecih zdravljenja.
English: For more information about treatment with Onsenal, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Onsenal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The recommended dose of Onsenal is 400 mg twice a day with food.
Slovenian: Priporočeni odmerek zdravila Onsenal je 400 mg dvakrat dnevno s hrano.
English: COX-2 is found at high levels in adenomatous colorectal polyps.
Slovenian: Velike količine COX-2 najdemo tudi v adenomatoznih kolorektalnih polipih.
English: Because the number of patients with FAP is low, the disease is considered ‘rare', and Onsenal was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 November 2001.
Slovenian: Ker je število bolnikov s familiarno adenomatozno polipozo majhno, velja ta bolezen za redko, zato je bilo zdravilo Onsenal dne 20. novembra 2001 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Onsenal, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: For the full list of restrictions, see the
Slovenian: Za celoten seznam omejitev glejte navodilo za uporabo.
English: The maximum recommended daily dose of Onsenal is 800 mg.
Slovenian: Največji priporočeni dnevni odmerek zdravila Onsenal je 800 mg.
English: This document is a summary of the European Public Assessment Report (EPAR) for Onsenal.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Onsenal.
English: In the study, 25 patients had an intact colon, but the remainder had had some or all of their colon removed through surgery.
Slovenian: V študiji je bil pri 25 bolnikih kolon cel, pri preostalih pa je bil v celoti ali delno kirurško odstranjen.
English: The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high blood pressure) and diarrhoea.
Slovenian: Najpogostejša neželena učinka zdravila Onsenal (opažena pri več kot 1 bolniku od 10) sta hipertenzija (povišani krvni tlak) in driska.
English: Onsenal is a medicine that contains the active substance celecoxib.
Slovenian: Onsenal je zdravilo, ki vsebuje zdravilno učinkovino celekoksib.
English: What is the risk associated with Onsenal?
Slovenian: Kakšna tveganja so povezana z zdravilom Onsenal?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Onsenal is available
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Onsenal je na voljo tukaj.
English: The Committee recommended that Onsenal be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Onsenal odobri dovoljenje za promet.
English: Onsenal must not be given to pregnant women or women who could become pregnant unless they are using an effective method of contraception, or to women who are breast-feeding.
Slovenian: Zdravila Onsenal ne smejo uporabljati nosečnice in ženske, ki bi lahko zanosile, razen če uporabljajo učinkovito kontracepcijsko zaščito, ali ženske, ki dojijo.
English: What information is still awaited for Onsenal?
Slovenian: Katere informacije o zdravilu Onsenal še pričakujemo?
English: In adults, Onsenal had reduced the average number of polyps by 28% after six months, while the number had fallen by 5% in the patients taking placebo.
Slovenian: Po šestih mesecih je zdravilo Onsenal pri odraslih zmanjšalo povprečno število polipov za 28 %, pri tistih, ki so prejemali placebo, pa se je to število zmanjšalo za 5 %.
English: In patients with moderate liver disease, the dose of Onsenal should be halved.
Slovenian: Pri bolnikih z zmerno jetrno okvaro je treba odmerek zdravila Onsenal zmanjšati za polovico.
English: The CHMP decided that Onsenal's benefits are greater than its risks but noted that no effect of Onsenal on the risk of developing cancer of the intestine had been shown.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Onsenal večje od z njim povezanih tveganj, vendar je pripomnil, da vpliv zdravila Onsenal na tveganje za nastanek raka v črevesju ni bil dokazan.
English: By blocking the activity of COX-2, celecoxib helps to slow down the formation of polyps by stopping them developing their own blood supply and by increasing the rate of cell death.
Slovenian: Celekoksib z zaviranjem delovanja COX-2 pripomore k upočasnitvi nastajanja polipov, saj prepreči njihovo lastno oskrbo s krvjo ter pospeši odmiranje celic v polipih.
English: Onsenal is used in addition to surgery (to remove the polyps) and endoscopic monitoring (to check if polyps are developing, using an endoscope, a thin tube that allows a doctor to look inside the gut).
Slovenian: Zdravilo Onsenal se uporablja kot dodatek operaciji (za odstranitev polipov) in endoskopskemu nadzoru (preverjanju, ali nastajajo polipi, kar se opravi z endoskopom - tanko cevko, s katero zdravnik lahko opazuje notranjost črevesja).
English: Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP).
Slovenian: Zdravilo Onsenal se uporablja za zmanjšanje števila polipov pri bolnikih s familiarno adenomatozno polipozo (FAP).
English: The company that makes Onsenal has committed to carrying out a study in patients with FAP, in order to collect more information on the medicine's safety and effectiveness.
Slovenian: Družba, ki izdeluje zdravilo Onsenal, bo opravila študijo pri bolnikih s familiarno adenomatozno polipozo, da bi zbrala več podatkov o varnosti in učinkovitosti zdravila.
English: The active substance in Onsenal, celecoxib, is a ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'.
Slovenian: Zdravilna učinkovina zdravila Onsenal, celekoksib, je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino „zaviralcev ciklooksigenaze 2 (COX-2)“.
English: Onsenal has been studied in one main study involving 83 adults (aged 18 years or over) with FAP, in which two doses of Onsenal were compared with placebo (a dummy treatment).
Slovenian: Zdravilo Onsenal so proučevali v eni glavni študiji, v katero je bilo vključenih 83 odraslih (starih najmanj 18 let) s familiarno adenomatozno polipozo in v kateri so dva odmerka zdravila Onsenal primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in processes such as inflammation and the activity of smooth muscle (muscle that performs automatic tasks such as the opening and closing of blood vessels).
Slovenian: Celekoksib zavira encim COX-2, kar povzroči zmanjšanje nastajanja prostaglandinov, tj. snovi, ki sodelujejo pri procesih, kot so vnetja in dejavnosti gladkih mišic (mišic, ki opravljajo samodejne dejavnosti, kot so odpiranje in zapiranje žil).
English: Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Slovenian: Zdravila Onsenal ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) celekoksib, katero koli drugo sestavino zdravila ali sulfonamide (nekatere antibiotike).
English: This is a genetic disease that causes ‘adenomatous intestinal polyps', growths that project from the lining of the colon or rectum (large intestine).
Slovenian: To je genetska bolezen, pri kateri nastajajo „adenomatozni intestinalni polipi“, izrastki na sluznici kolona ali danke (debelega črevesa).