natgillin/translations-raw huggingface dataset:
EudraCT (In production) 
EudraCT (v izdelavi)
Eighty-one PSURs were received in 2007 for centrally authorised medicines. 
V letu 2007 je bilo prejetih 81 z zadnjimi podatki dopolnjenih rednih poročil o varnosti za zdravila, za katera je bilo dovoljenje za promet izdano po centraliziranem postopku.
Eudra DataWarehouse (In pre-production) 
Podatkovno skladišče Eudra (v predhodni izdelavi)
General contribution 
Glavne dejavnosti
January 1998 
januar 1998
However, the CHMP considered that few points merit further clarification. 
Vendar je odbor CHMP menil, da nekaj točk zahteva dodatno pojasnitev.
The conditions affecting the marketing authorisations are set out in Annex IV. 
Pogoji dovoljenja za promet z zdravilom, so navedeni v Prilogi IV.
The first adrenaline auto-injectors (AAI) were developed and introduced into the medical market approximately 25 years ago in the USA. 
Prve samoinjektorje adrenalina so razvili in na trg zdravil v ZDA uvedli pred približno 25 leti.
Auto-injectors were invented in the 1960s following military research in the United States of America (USA). 
Samoinjektorje so v 60-tih letih 20. stoletja s pomočjo vojaških raziskav izumili v Združenih državah Amerike (ZDA).
The matter was then referred to the Committee for Medicinal Products for Human Use (CHMP) for a review under Article 31 of Directive 2001/83/EC. 
Zadevo so napotili na Odbor za zdravila za humano uporabo (CHMP), ki jo bo pregledal skladno s členom 31 Direktive 2001/83/ES.
The fact that 15% of mothers were unable to ‘fire' the auto-injector successfully supports that patients' training tools need to be improved and that training needs to be repeated at regular intervals. 
Ker 15 % mater ni uspelo „sprožiti“ samoinjektorja, je treba izboljšati orodja za usposabljanje bolnikov in usposabljanje ponavljati v rednih presledkih.
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for adrenaline auto-injectors. 
• odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za samoinjektorje adrenalina;
The barrier of the fascia lata - the fibrous tissue surrounding the muscle - also needs to be considered. 
Upoštevati je treba tudi pregrado s stegensko fascijo (fibrozno tkivo, ki obkroža mišico).
The CHMP noted the lack of clinical evidence from randomised, controlled trials, due to the logistical and ethical problems involved with conducting such trials in emergency situations, particularly with a placebo control. 
Odbor CHMP je ugotovil pomanjkanje kliničnih dokazov iz randomiziranih nadzorovanih preskušanj zaradi logističnih in etičnih težav pri izvajanju takih preskušanj v nujnih primerih, predvsem s kontrolno skupino s placebom.
The main clinical data available focus on demonstrating the skin-to-muscle depth (STMD) in adults and children and the CHMP noted that there is inconsistency across the studies with some finding no correlation between STMD and Body Mass Index (BMI) or weight (Song (2005)3, Stecher (2009)4) and others finding a correlation (Bhalla (2013)5, Bewick (2013)6). 
Glavni razpoložljivi klinični podatki so osredotočeni na dokazovanje globine med kožo in mišico ({i>skin-to-muscle depth,<i} STMD) pri odraslih ter otrocih, odbor CHMP pa je opazil neskladja med študijami, saj v nekaterih niso ugotovili nobene povezave med STMD in indeksom telesne mase (ITM) ali telesno maso (Song (2005)3, Stecher (2009)4), v drugih pa so odkrili povezavo (Bhalla (2013)5, Bewick (2013)6).
The CHMP agreed that proper training of both patients/carers and healthcare professionals and comprehensive educational materials are of paramount importance. 
Odbor CHMP se je strinjal, da so ustrezno usposabljanje za bolnike/negovalce in zdravstvene delavce ter izčrpni izobraževalni materiali izjemno pomembni.
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP recommends the variation to the terms of the marketing authorisation for all medicinal products referred to in Annex I and for which the amendments of the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III. 
Zato je skladno s členoma 31 in 32 Direktive 2001/83/ES priporočil spremembo pogojev dovoljenj za promet z vsemi zdravili, ki so navedena v Prilogi I, skladno s spremembami ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III.
Results from PK studies (Simons, 19981, 20012) support the guidelines recommendation (e.g. UK Resuscitation Guideline) that an intramuscular injection is the preferred route of administration in the treatment of anaphylaxis as a rapid response is important in ensuring a non-fatal outcome. 
Rezultati FK-študij (Simons 19981, 20012) podpirajo priporočila za smernice (npr. Smernico za oživljanje Združenega kraljestva, {i>UK Resuscitation Guideline<i}), ki navajajo, da je intramuskularno injiciranje prednostna pot uporabe pri zdravljenju anafilaksije, saj je hiter odziv pomemben pri zagotavljanju nesmrtnega izida.
They were originally used for the administration in the field of atropine, the antidote to nerve agents in biological weapons. 
Prvotno so se uporabljali za terensko injiciranje atropina, protistrupa za snovi v bioloških orožjih, ki delujejo na živčevje.
The STMD is only one factor affecting whether or not the adrenaline reaches the muscle layer. 
STMD je samo eden izmed dejavnikov, ki vpliva na to, ali adrenalin doseže mišično plast ali ne.
A key finding of the review was that there is no robust evidence that the administration devices deliver adrenaline intramuscularly in all patients. 
Ključna ugotovitev pregleda je bila odsotnost trdnih dokazov, da pripomočki za injiciranje adrenalin dovajajo intramuskularno pri vseh bolnikih.
The experts consulted unanimously agreed that a PK study in humans would be useful in order to gain information on the optimum parameters of administration; the group also noted the possibility to collect PD data in this same study. 
Strokovnjaki so se soglasno strinjali, da bi bila FK-študija pri ljudeh koristna za pridobivanje informacij o optimalnih parametrih uporabe; ugotovili so tudi, da je mogoče v isti študiji zbirati tudi FD-podatke.
The CHMP acknowledged that patient/carer compliance with the use of the auto-injectors is also very important as evidenced by the study by Brown J et al (2015)7. 
Odbor CHMP je upošteval, da je doslednost bolnika/negovalca pri uporabi samoinjektojev prav tako zelo pomembna, kar so v svoji študiji ugotovili Brown J in sod (2015)7.
The CHMP considered also the results of consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC). 
Prav tako je upošteval rezultate posvetov z zdravstvenimi delavci, strokovnjaki in Odborom za oceno tveganja na področju farmakovigilance (PRAC).
While these non-clinical models have demonstrated that the adrenaline is projected beyond the tip of the needle to a greater or lesser extent the CHMP was of the view that it remains questionable how representative of the human tissue these models are. 
Čeprav so s nekliničnimi modeli pokazali, da adrenalin prodre dlje od konice igle v večjem ali manjšem obsegu, je odbor CHMP menil, da je še vedno vprašljivo, ali lahko te modele primerjamo s človeškim tkivom.
Most of the evidence for penetration of adrenaline into the tissue relies on non-clinical data using a gelatin model or a porcine model. 
Večina dokazov za prodiranje adrenalina v tkivo temelji na nekliničnih podatkih, ki vključujejo uporabo želatinskega modela ali prašičjega modela.
Clinical Communication 7 Brown J, Tuthill D, Alfaham M et al. (2013) A randomised maternal evaluation of epinephrine autoinjection devices. 
Klinična dokumentacija 7 Brown J, Tuthill D, Alfaham M et al. (2013) A randomised maternal evaluation of epinephrine autoinjection devices.
The CHMP also recommended further risk minimisation measures, including educational materials, to be submitted and agreed via risk management plans. 
Odbor CHMP je priporočil tudi dodatne ukrepe za zmanjševanje tveganja, vključno z izobraževalnimi gradivi, ki jih je treba predložiti in odobriti prek načrtov obvladovanja tveganja.
However, there is insufficient evidence to ensure, even under optimal circumstances, IM delivery of adrenaline to all patients with the currently available auto-injectors authorised in the EU and, even if the medicine is delivered IM, that exposure from a single injection will be sufficient. 
Vendar ni zadostnih dokazov, da je, celo v optimalnih okoliščinah s trenutno razpoložljivimi samoinjektorji, odobrenimi v EU, intramuskularno injiciranje adrenalina zagotovljeno vsem bolnikom, in da tudi, če se zdravilo daje intramuskularno ni nujno, da bo eno injiciranje zadostno.
Until these uncertainties can be resolved, there is a need for more definitive evidence in humans of the speed and extent of delivery of adrenaline into the circulation following use of different adrenaline auto-injectors, from which it may be possible to infer site of delivery. 
Dokler te negotovosti ne bodo razrešene, je treba pridobiti več gotovih dokazov pri človeku glede hitrosti in obsega dovajanja adrenalina v krvni obtok po uporabi različnih samoinjektorjev adrenalina, na podlagi katerih bi bilo mogoče zanesljivo določiti mesto dovajanja.
Training and education of both patients/carers and healthcare professionals was considered of paramount importance. 
Ključnega pomena sta usposabljanje in izobraževanje bolnikov/negovalcev in zdravstvenih delavcev;
Published clinical data indicate that the rate of absorption is prolonged if the adrenaline is delivered subcutaneously (SC). 
Objavljeni klinični podatki kažejo, da je hitrost absorpcije podaljšana, če se adrenalin daje subkutano.
The efficacy of adrenaline in the treatment of anaphylaxis is well-supported by anecdotal and retrospective evidence. 
Učinkovitost adrenalina pri zdravljenju anafilaksije je dobro podprta z anekdotičnimi in retrospektivnimi dokazi.
The PRAC considered that there were no identified data sources that would permit a formal epidemiological approach for assessing actual usage or device failure of adrenaline auto-injectors in the EU. 
Odbor PRAC ni ugotovil nobenih podatkovnih virov, ki bi omogočali uraden epidemiološki pristop pri ocenjevanju dejanske uporabe ali odpovedi samoinjektorjev adrenalina v EU.
The educational materials include but are not limited to a training device, instructional audio-visual material and a checklist for prescribers aiming to facilitate the discussion between the prescriber and the patient and to provide sufficient information on the optimal way of use, administration and storage of the product. 
Izobraževalna gradiva med drugim vključujejo pripomoček za usposabljanje, avdiovizualno gradivo in kontrolne sezname za predpisovalce, ki omogočajo posvet med predpisovalcem ter bolnikom in vsebujejo dovolj informacij za optimalni način uporabe, injiciranja in shranjevanja zdravila.
Adrenaline auto-injectors are indicated in the emergency treatment of severe allergic reactions (anaphylaxis) to e.g. insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis. 
Samoinjektorji adrenalina so indicirani za nujno zdravljenje hudih alergijskih reakcij (anafilaksije) na npr. pike ali ugrize insektov, hrano, zdravila in druge alergene ter idiopatske in s telesno vadbo izzvane anafilaksije.
The use of adrenaline to treat anaphylaxis is established as the recommended first-line treatment. 
Uporaba adrenalina za zdravljenje anafilaksije je uveljavljena kot priporočeno zdravljenje prve izbire.
The needle length is another factor and the UK Resuscitation Council Guidelines do suggest a 25mm needle is optimal for intramuscular injection; however the CHMP noted that these guidelines are written for use in the hospital setting where healthcare professionals will generally inject the adrenaline using a manual needle and syringe, not an auto-injector. 
Drugi dejavnik je dolžina igle in Smernice odbora Združenega kraljestva za oživljanje navajajo, da je igla dolžine 25 mm optimalna za intramuskularno injiciranje, vendar je odbor CHMP opazil, da so te smernice napisane za uporabo v bolnišničnem okolju, kjer zdravstveni delavci adrenalin navadno injicirajo ročno z iglo ter injekcijsko brizgo in ne s samoinjektorjem.
The safety of adrenaline is also well-established, and it has demonstrated a particularly strong safety profile with intramuscular (IM) administration. 
Varnost adrenalina je prav tako dobro uveljavljena, zelo dober varnostni profil pa so dokazali pri intramuskularnem injiciranju.
Variability in skin-to-muscle depth (STMD), gender, needle length and the device mechanism itself are important factors which determine whether the route of delivery is IM or SC. 
Spremenljivost globine med kožo in mišico, spol, dolžina igle in mehanizem pripomočka so pomembni dejavniki, ki določajo, ali bo injiciranje intramuskularno ali subkutano.
The CHMP sought the advice of experts on the feasibility of conducting imaging or PK studies or any other trials or tests that could be performed as well as the advice of the PRAC on potential databases or other data sources that might hold information on actual device usage. 
Odbor CHMP se je posvetoval s strokovnjaki glede možnosti izvedbe študij s slikanjem ali FK-študij ali katerih koli drugih preskušanj ali preiskav in odborom PRAC glede morebitnih podatkovnih zbirk ali drugih podatkovnih virov, ki bi lahko vsebovali informacije o dejanski uporabi pripomočka.
The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) undertook a review of all authorised adrenaline auto-injectors to evaluate the most effective site for injection, the clarity of instructions for use as well as the most appropriate auto-injector needle length for ensuring intramuscular (IM) delivery of the adrenaline injection. 
Regulativna agencija za zdravila in medicinske pripomočke Združenega kraljestva (MHRA) je pregledala vse odobrene samoinjektorje adrenalina, da bi ocenila najučinkovitejše mesto injiciranja, jasnost navodil za uporabo in najprimernejšo dolžino igle v samoinjektorju za zagotavljanje intramuskularnega injiciranja adrenalina.
Other factors such as the mechanism of action (spring loaded or not) and method of administration (swing and jab or place and press) of the device, the angle of placement on the skin and the force used to activate the device also play a part. 
Pri tem imajo vlogo tudi drugi dejavniki, kot so mehanizem delovanja (vzmeteni ali ne), način uporabe pripomočka (zamah in vbod ali namestitev in pritisk), kot namestitve na kožo in sila, ki se uporabi za aktivacijo pripomočka.
The CHMP noted the inconsistency amongst studies as to the part played by compression of the tissue. 
Odbor CHMP je ugotovil neskladja med študijami glede vloge, ki jo ima stisnjenje tkiva.
Some investigators are of the opinion that even when the needle length is shorter than the STMD, IM injection is still possible as the physical compression of subcutaneous tissue by the force of the device can help to overcome the deficit in needle length. 
Nekateri raziskovalci menijo, da je intramuskularno injiciranje mogoče kljub krajši dolžini igle od STMD, saj lahko fizikalna kompresija podkožnega tkiva s silo pripomočka pomaga pri kompenzaciji za prekratko iglo.
On the other hand, other investigators express an opinion that compression may preferentially involve muscle rather than subcutaneous tissue and therefore the needle deficit is not overcome by compression. 
Drugi raziskovalci pa menijo, da lahko kompresija vključuje predvsem mišico in ne podkožnega tkiva, zato kompresija ne kompenzira za prekratko iglo.
If IM delivery is insufficient with one injection, administration of a second injection is recommended. 
Če je enkratno intramuskularno injiciranje nezadostno, se priporoča še eno injiciranje.
• The CHMP considered that there are multiple factors that may affect whether adrenaline is delivered to the muscle or the subcutaneous tissue when an adrenaline auto-injector is used such as the needle length, the mechanism of action of the device, the angle of placement on the skin, the force used to activate the device and the patient/carer compliance. 
• odbor CHMP je menil, da je prisotnih več faktorjev, ki lahko vplivajo na to, ali se ob uporabi samoinjektorja adrenalin dovaja v mišico ali podkožno tkivo, kot so dolžina igle, mehanizem delovanja pripomočka, kot namestitve na koži, sila pri aktivaciji pripomočka in bolnikova/negovalčeva doslednost.
The CHMP has considered the totality of the available non-clinical and clinical evidence on the delivery of adrenaline from adrenaline auto-injectors and on whether the product information contains clear and detailed instructions for appropriate use. 
Odbor CHMP je pretehtal vse razpoložljive neklinične in klinične dokaze o dovajanju adrenalina s samoinjektorji ter presodil, ali informacije o zdravilu vsebujejo jasna in podrobna navodila za pravilno uporabo.
The CHMP noted that generally there is a large degree of consistency between the product information for the different auto-injectors in particular as regards main messages such as to seek emergency medical assistance immediately after a single administration, the use with caution in certain patient populations and that adrenaline should be administered intramuscularly in order to maximise the possibility of a positive outcome in the treatment of anaphylaxis. 
Odbor CHMP je menil, da so informacije o zdravilih za različne samoinjektorje pretežno skladne, predvsem glede glavnih sporočil, kot so, naj bolnik po enem injiciranju takoj poišče zdravniško pomoč, previdna uporaba pri nekaterih skupinah bolnikov in nujnost intramuskularnega injiciranja adrenalina, da se čim bolj poveča možnost pozitivnega izida pri zdravljenju anafilaksije.
• The CHMP considered the totality of the available non-clinical and clinical data to inform whether adrenaline administered via an auto-injector is delivered intramuscularly or subcutaneously, including submissions by marketing authorisation holders, consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC). 
• odbor CHMP je pretehtal vse razpoložljive neklinične in klinične podatke o intramuskularnem in subkutanem injiciranju adrenalina s samoinjektorji adrenalina, vključno z vlogami imetnikov dovoljenja za promet z zdravilom ter posveti z zdravstvenimi delavci, strokovnjaki in Odborom za oceno tveganja na področju farmakovigilance (PRAC);
• The CHMP considered that the preferred route of administration of adrenaline in an emergency situation has been established as IM, although intravenous administration may be indicated in severe cases. 
• odbor CHMP je menil, da je prednostni način uporabe adrenalina v nujnih primerih intramuskularen, čeprav se lahko v hudih primerih uporabi intravensko injiciranje;
However, the CHMP was of the view that PK and PD studies in healthy volunteers representing the broad range of phenotypes, or imaging studies in healthy volunteers to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device could be considered. 
Vendar je odbor CHMP menil, da je mogoče upoštevati FK- in FD-študije pri zdravih prostovoljcih, ki predstavljajo širok razpon fenotipov, ali študije s slikanjem pri zdravih prostovoljcih, ki pomagajo razumeti vpliv različnih dejavnikov na razporeditev, izpostavljenost in aktivnost adrenalina, kadar se daje s samoinjektorjem adrenalina.
Furthermore, the CHMP imposed a PK/PD study in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device and encouraged the possibility for a study to assess the effectiveness of the proposed risk minimisation measures and the conduct of an observational study to assess usage and incidence of lack of efficacy and device failure. 
Poleg tega je odbor CHMP zahteval izvedbo FK-/FD-študije, s katero bi pojasnili vpliv različnih dejavnikov na porazdelitev, izpostavljenost in aktivnost adrenalina, kadar se daje s samoinjektorjem, in spodbudil možnost študije za ocenjevanje učinkovitosti predlaganih ukrepov za zmanjševanje tveganja ter opazovalne študije za ocenjevanje uporabe in primere pomanjkljive učinkovitosti in odpovedi pripomočka.
However, there is agreement that in general STMD is greater than the length of the needles of currently available adrenaline auto-injectors in many patients, both adult and child. 
Vendar velja soglasje, da je STMD pri mnogih bolnikih (odraslih in otrocih) večji od dolžine igel trenutno razpoložljivih samoinjektorjev adrenalina.
• The CHMP considered that the efficacy of adrenaline in the treatment of anaphylaxis is wellsupported by anecdotal and retrospective evidence and that the safety of adrenaline is also well-established, and it has demonstrated a strong safety profile particularly with IM administration. 
• odbor CHMP je menil, da je učinkovitost adrenalina pri zdravljenju anafilaksije dobro podprta z anekdotičnimi in retrospektivnimi dokazi ter da je varnost adrenalina prav tako dobro podprta.
The CHMP therefore recommended amendments to the product information, in order to reflect the uncertainties in whether a single administration would suffice for any given episode and advise that patients are prescribed two pens which they should carry at all times, to include a recommendation for immediate associates of patients to be trained to use the AAI and to include information on the needle length. 
Odbor CHMP je zato priporočil spremembe informacij o zdravilih, tako da bodo odražale nejasnosti, ali je enkratna uporaba zadostna za vse epizode, in svetovale, naj zdravnik bolnikom predpiše dva peresnika, ki ju morajo imeti vedno pri sebi, prav tako pa vključile priporočilo za najbližje pomočnike bolnika, naj se usposobijo v uporabi samoinjektorjev adrenalina, in informacije o dolžini igle.
The CHMP concluded that the benefit-risk balance for adrenaline auto-injectors remains favourable subject to the conditions to the marketing authorisations and taking into account the amendments to the product information and other risk minimisation measures recommended. 
Odbor CHMP je zaključil, da je razmerje med tveganji in koristmi samoinjektorjev adrenalina še naprej ugodno pod pogojem, da se upoštevajo pogoji dovoljenj za promet z zdravili ter spremembe informacij o zdravilu in drugi priporočeni ukrepi za zmanjšanje tveganja.
The CHMP agreed that there are many factors that may affect whether the adrenaline is delivered to the muscle or the subcutaneous tissue when an adrenaline auto-injector is used. 
Odbor CHMP se je strinjal, da lahko na injiciranje adrenalina v mišico ali podkožno tkivo ob uporabi samoinjektorja adrenalina vpliva več dejavnikov.
The preferred route of administration in an emergency situation has been established as IM, although intravenous administration may be indicated in severe cases. 
Prednostni način uporabe v nujnih primerih je intramuskularen, čeprav se lahko v hudih primerih uporabi intravensko injiciranje.
It is widely accepted that IM delivery is superior to SC delivery in achieving the rate of rise and levels of plasma adrenaline that are most effective to treat anaphylaxis. 
Na splošno velja, da je intramuskularna uporaba pri doseganju hitrega povišanja ravni adrenalina v plazmi, ki je najučinkovitejše za zdravljenje anafilaksije, boljša od subkutane uporabe.