natgillin/translations-raw huggingface dataset:
Dutrebis must be used in combination with other HIV medicines.
Zdravilo Dutrebis je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
It is used together with other HIV medicines and can be used in patients from 6 years of age and weighing at least 30 kg.
Uporablja se skupaj z drugimi zdravili proti virusu HIV in je namenjeno bolnikom, starejšim od
For practical information about using Dutrebis, patients should read the package leaflet or contact their
Za praktične informacije o uporabi zdravila Dutrebis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the European Union for Dutrebis on 26 March 2015.
Evropska komisija je dovoljenje za promet z zdravilom Dutrebis, veljavno po vsej Evropski uniji, izdala
Of these 319 cases, almost all (98%) are from Sweden (67%) and Australia (31%).
Od teh 319 primerov so skoraj vsi (98 %) s Švedske (67 %) in iz Avstralije (31 %).
However, this has to be put in perspective of the limited exposure.
Vendar je to treba obravnavati z vidika omejene izpostavljenosti.
Diliban retard is not yet placed in the EU market.
Zdravilo Diliban retard še ni bilo dano na trg EU.
Seven cases were reported to be unintentional but none of them were fatal.
Po poročilih je bilo sedem primerov nenamernih, nobeden od njih pa ni bil smrten.
The PRAC adopted a recommendation on 30 November 2017 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 30. novembra 2017 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
Most episodes of hepatotoxicity occur as a result of late presentation to hospital.
Večina epizod hepatotoksičnosti je posledica poznega prihoda v bolnišnico.
Conclusions on the benefit-risk balance following the re-examination procedure
Zaključki o razmerju med tveganji in koristmi po postopku ponovne proučitve
A second expert group meeting was convened.
Sklicano je bilo drugo srečanje strokovne skupine.
There were 5 fatal cases reported out of the 319 cases.
Med 319 primeri, o katerih so poročali, je bilo pet smrtnih.
It has to also be taken into account that there could be a subgroup of tramadol abusers in which risk of suicidality is different.
Treba je upoštevati tudi, da lahko obstaja podskupina bolnikov, ki zlorabljajo tramadol, pri katerih je tveganje za samomorilnost drugačno.
In addition, due to the presence of opioid component, there is risk of unintentional overdose.
Poleg tega zaradi prisotnosti opioidne sestavine obstaja tudi tveganje za nenamerno preveliko odmerjanje.
Dose is an important factor when interpreting poisoning data with paracetamol.
Odmerek je pomemben dejavnik pri razlagi podatkov o zastrupitvi s paracetamolom.
The majority of patients recovered or improved while 2 patients needed liver transplants.
Večina bolnikov je okrevala oziroma se je njihovo stanje izboljšalo, dva bolnika pa sta potrebovala presaditev jeter.
This includes unexpectedly prolonged paracetamol exposure and double peaks.
To vključuje nepričakovano podaljšano izpostavljenost paracetamolu in dvojne vrhove.
Indeed, the product is already under prescription in the EU concerned Member States except in Portugal - this measure would have an effect limited to PT and would not further minimise the risk in other EU Member States.
Zdravilo se že izdaja le na recept v zadevnih državah članicah EU razen Portugalske - učinek tega ukrepa bi bil tako omejen le na Portugalsko, v drugih državah članicah EU pa tveganja ne bi nadalje zmanjšal.
It is acknowledged that the rate of overdose is not the same in all EU MSs depending on different factors (e.g. legal status, pattern of use of pain relief medicines).
Priznava se, da stopnja prevelikega odmerjanja ni enaka v vseh državah članicah EU in je odvisna od različnih dejavnikov (npr. pravnega statusa, načina uporabe protibolečinskih zdravil).
Available data indicates that patients considered at high risk of hepatotoxicity are those with high initial paracetamol concentrations.
Razpoložljivi podatki kažejo, da so bolniki, ki imajo večje tveganje za hepatotoksičnost, tisti, ki imajo visoke začetne koncentracije paracetamola.
Under normal conditions of use, it has an established favourable benefit/risk profile.
V normalnih pogojih uporabe ima ugotovljeno ugodno razmerje med koristmi in tveganji.
The overdose treatment guidelines also differ among MSs depending on the healthcare systems.
Tudi smernice zdravljenja prevelikega odmerjanja se med državami članicami razlikujejo glede na zdravstveni sistem.
Available data clearly suggest that treatment with NAC should not be discontinued before additional paracetamol concentration and ALT value have been determined.
Razpoložljivi podatki jasno kažejo, da se zdravljenje z NAC ne sme prekiniti, dokler se ne določi dodatna koncentracija paracetamola in vrednost ALT.
Overall summary of the scientific evaluation by the PRAC Paracetamol is one of the most commonly utilised compounds worldwide; its use as an anti-pyretic or analgesic drug has been predominant since 1955.
Splošni povzetek znanstvenega vrednotenja odbora PRAC Paracetamol je ena najpogosteje uporabljenih učinkovin na svetu; kot antipiretik in analgetik prevladuje že od leta 1955.
In the literature only few studies investigate whether treatment guidelines are followed and these are mostly done with IR formulation and mainly in Australia.
V literaturi je objavljenih le nekaj študij, ki proučujejo upoštevanje smernic zdravljenja, večina med njimi pa je bila opravljena s formulacijo s takojšnjim sproščanjem in večinoma v Avstraliji.
It is agreed in the scientific community that massive overdoses are particularly challenging to handle.
Znanstvena skupnost se strinja, da so izrazito preveliki odmerki še poseben izziv, ki ga je treba obravnavati.
Following the adoption of the PRAC recommendation in September 2017, two MAHs (GSKCH and KRKA d.d., Novo mesto) have requested the re-examination of the recommendation and submitted detailed grounds for the re-examination.
Po sprejetju priporočila odbora PRAC septembra 2017 sta dva imetnika dovoljenja za promet z zdravilom (GSKCH in KRKA d.d., Novo mesto) zahtevala ponovno proučitev priporočila in predložila podrobno opisane razloge zanjo.
Out of these, six patients developed hepatotoxicity (ALT >1000 IU/L).
Od teh se je pri šestih bolnikih pojavila hepatotoksičnost (ALT > 1 000 i.e./l).
Having reviewed the PRAC recommendation, the CMDh agree with the PRAC overall conclusions and grounds for recommendation.
Po pregledu priporočila odbora PRAC se je odbor CMDh strinjal s končnimi zaključki odbora PRAC in s podlago za priporočilo.
PRAC was in agreement with the experts views.
Odbor PRAC se je strinjal s stališči strokovnjakov.
PRAC discussion on the detailed grounds for re-examination
Razprava odbora PRAC v zvezi s podrobno opisanimi razlogi za ponovno proučitev
However, it is unclear if such a recommendation is feasible and will result in effective risk minimisation throughout the EU, since the operations of these Centres are different in the EU Member States.
Vendar pa ni jasno, ali je tovrstno priporočilo izvedljivo in ali se bo s tem učinkovito zmanjšalo tveganje po vsej EU, saj se delovanje teh centrov med državami članicami EU razlikuje.
The PRAC acknowledged the limitations of the existing studies as they were not designed to compare influence of dose versus formulation on unpredictable PK or outcome.
Priznal je omejitve obstoječih študij, saj niso bile zasnovane za primerjavo vpliva odmerka glede na formulacijo na nepredvidljivo farmakokinetiko ali izid.
The CMDh considered the documentation submitted by one MAH (KRKA d.d., Novo mesto) in support of their product and concluded that it did not affect the conclusions of the PRAC.
Skupina CMDh je obravnavala dokumentacijo, ki jo je predložil en imetnik dovoljenja za promet z zdravilom (KRKA d.d., Novo mesto) v podporo svojemu zdravilu, in zaključila, da ne vpliva na zaključke odbora PRAC.
The PRAC also considered risk management of overdoses with paracetamol in general, both in the EU and world-wide.
Odbor PRAC je obravnaval tudi obvladovanje tveganja za preveliko odmerjanje paracetamola na splošno v EU in po svetu;
In this sense, the second expert group meeting expressed the view that the model currently proposed by the MAH was not sufficient due to sample size limitation and further methodological challenges.
V tem smislu so na drugem srečanju strokovne skupine izrazili mnenje, da model, ki ga je trenutno predlagal imetnik dovoljenja za promet z zdravilom, zaradi omejitev velikosti vzorca in nadaljnjih metodoloških izzivov ne zadošča.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for modified release paracetamol containing medicinal products (see Annex I).
• odbor PRAC je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo paracetamol s prirejenim sproščanjem (glejte Prilogo I);
Notwithstanding the feasibility of a revised overdose protocol, it is not acceptable for the PRAC to expose the patients to such revised protocol without sufficient evidence on its effectiveness.
Ne glede na izvedljivost pregledanega protokola za preveliko odmerjanje za odbor PRAC ni sprejemljivo, da bi bolnike tovrstnemu pregledanemu protokolu izpostavljali brez zadostnih dokazov o njegovi učinkovitosti.
For the individual patient who has taken an MR overdose this means a longer and more complex encounter with health care services, and an uncertainty if adequate treatment can be provided.
Pri posameznem bolniku, ki je zaužil prevelik odmerek s prirejenim sproščanjem, to pomeni daljšo in zapletenejšo obravnavo pri zdravstvenih delavcih ter negotovost, ali je mogoče zagotoviti ustrezno zdravljenje.
The evidence of the efficacy in acute pain is more robust but the clinical need of a mofidied-release formulation is less important and the claimed benefits of the medicinal product are not substantial for this clinical setting.
Dokazi učinkovitosti pri akutni bolečini so tdrnejši, vendar je klinična potreba po formulaciji s prirejenim sproščanjem manj pomembna in navedene koristi zdravila v tem kliničnem primeru niso bistvenega pomena.
An ad-hoc expert group meeting was held within this procedure with scientific and clinical experts in the management of poisoning.
V okviru postopka se je sestala priložnostna strokovna skupina znanstvenih in kliničnih strokovnjakov za obravnavo zastrupitev.
Data from the study by Chiew and colleagues (2017) indicates that rate of hepatotoxicity declines when either activated charcoal or increased NAC dose are administered to patients.
Podatki študije, ki so jo opravili Chiew in sodelavci (2017), kažejo, da se stopnja hepatotoksičnosti zmanjšuje, kadar bolniki prejmejo aktivno oglje ali večji odmerek NAC.
However, study by Carroll and colleagues (2015) that investigated the influence of the change to UK overdose treatment guidelines showed that a proportion of patients is already being treated on a case by case basis, independently of existing UK treatment guidelines.
Študija, ki so jo opravili Carroll in sodelavci (2015), v kateri so proučevali vpliv sprememb smernic zdravljenja prevelikega odmerjanja v Združenem kraljestvu, je pokazala, da se določen del bolnikov že zdravi glede na posamezno presojo in neodvisno od obstoječih smernic zdravljenja v Združenem kraljestvu.
Eleven patients (21%) had a serum alanine aminotransferase (ALT), above the reference range (ALT >50 IU/L) at 24 h or later.
Pri enajstih bolnikih (21 %) so bile po 24 urah ali pozneje vrednosti serumske alanin-aminotransferaze (ALT) zunaj referenčnega razpona (ALT > 50 i.e./l).
Separate model for the combination, based on appropriate data would be necessary to address uncertainties in the management of a combination overdose.
Za kombinacijo bi bil potreben ločen model, oblikovan na podlagi ustreznih podatkov, ki bi obravnaval negotovosti pri zdravljenju prevelikega odmerjanja kombiniranega zdravila.
On the other hand, the experts also considered that there is insufficient evidence in this clinical setting to support the added value of tramadol/paracetamol MR formulation over other therapies in such population or any other patient group.
Po drugi strani so strokovnjaki menili tudi, da je v tem kliničnem primeru premalo dokazov, ki bi podpirali dodano vrednost formulacije s tramadolom/paracetamolom s prirejenim sproščanjem pred drugimi vrstami zdravljenja v tej populaciji ali v kateri koli drugi skupini bolnikov.
The measurement of the effectiveness of a modified model or new guidelines for treatment of MR paracetamol overdose was discussed by the second ad-hoc expert group, however the sample size (100 patients) was not considered sufficient.
O merjenju učinkovitosti spremenjenega modela ali novih smernic za zdravljenje prevelikega odmerjanja paracetamola s prirejenim sproščanjem je razpravljala druga priložnostna strokovna skupina, vendar velikost vzorca (100 bolnikov) ni bila ocenjena kot zadostna.
Furthermore, there are prolonged-release combination products containing tramadol/paracetamol 75 mg/650 mg.
Obstajajo tudi kombinirana zdravila s podaljšanim sproščanjem, ki vsebujejo tramadol/paracetamol v odmerku 75 mg/650 mg.
Paracetamol is used in various pain types such as headache, migraine, dysmenorrhoea, sore throat, musculoskeletal pain, pain after dental procedures/tooth extraction, toothache and the pain of osteoarthritis and for fever.
Uporablja se pri različnih vrstah bolečine, kot so glavobol, migrena, dismenoreja, boleče grlo, kostno-mišične bolečine, bolečine po posegu na zobeh/izdrtju zoba, zobobol in bolečine zaradi osteoartritisa, ter pri povišani telesni temperaturi.
The measures to improve the awareness on the risk of overdose (educational material, product information, labelling, DHPC) was not considered effective to prevent case of overdose, especially when intentional, as information to the patients and healthcare professionals is already extensive.
Ukrep izboljšanja zavedanja o tveganju prevelikega odmerjanja (izobraževalno gradivo, informacije o zdravilu, označevanje, neposredno obvestilo za zdravstvene delavce) ni bil ocenjen kot učinkovit pri preprečevanju prevelikega odmerjanja, zlasti namernega, saj so informacije za bolnike in zdravstvene delavce že zdaj obširne.
In this regard, the MAHs proposal to gain further experience on this proposed revised protocol by the means of a post-authorisation safety study was not endorsed.
Zato predlog imetnikov dovoljenj za promet z zdravilom, da bi dodatne izkušnje glede tega predlaganega pregledanega protokola pridobili s pomočjo študije varnosti po pridobitvi dovoljenja za promet z zdravilom ni bil sprejet.
The PRAC also considered, notwithstanding the feasibility and effectiveness concerns, that the shortcomings of such measures would not be proportionate, notably considering the modest benefits of these medicinal products.
Odbor PRAC je menil tudi, da ne glede na pomisleke o izvedljivosti in učinkovitosti pomanjkljivosti tovrstnih ukrepov ne bi bile sorazmerne, zlasti glede zmernih koristi teh zdravil.
Late crossing of the standard treatment nomogram were seen in 19% of the cases.
Pri 19 % primerov so opazili pozno prečkanje črte nomograma za standardno zdravljenje.
With regards to the small pack sizes, whilst these could have been an efficient measure to restrict availability, this would not be adequate for medicinal products mainly relevant in a chronic pain setting.
Kar zadeva majhne velikosti pakiranja, bi te sicer lahko bile učinkovit ukrep za omejitev razpoložljivosti, kar pa ne bi bilo primerno za zdravila, ki so večinoma pomembna pri kronični bolečini.
It was also noted that the FDA has recognised the dangers of the prescription combination of paracetamol and opioids and, in January 2014 implemented a fixed amount of paracetamol approved per dosage unit of combination.
Poudarjeno je bilo tudi, da je agencija ZDA za zdravila in prehrano (FDA) ugotovila nevarnosti kombinacije paracetamola in opioidov na recept ter je januarja 2014 uvedla točno določeno količino paracetamola, ki je odobrena na odmerno enoto kombinacije.
If the patient presents to emergency medical care in time following an overdose, there is an effective antidote available - N-acetylcysteine (NAC).
Če bolnik, po tem ko je vzel prevelik odmerek, pride na urgenco še pravočasno, obstaja učinkovit protistrup - N-acetilcistein (NAC).
Data published by the Swedish Poison Centre described a series of 53 patients with reported overdose with paracetamol 665mg MR (range 10-166 g).
Podatki, ki jih je objavil švedski center za zastrupitve, navajajo, da so pri 53 bolnikih poročali o prevelikem odmerjanju s paracetamolom 665 mg s prirejenim sproščanjem (razpon 10-166 g).
The main safety concern with paracetamol is hepatic toxicity following intake of high, supratherapeutic doses, which can be fatal unless adequately treated.
Glavni pomislek glede varnosti pri paracetamolu je toksičnost za jetra po vnosu velikih, supraterapevtskih odmerkov, ki so lahko smrtni, če se ne zdravijo ustrezno.
These include products with paracetamol as a single ingredient; namely modified release (MR) tablets containing 500 mg, 665 mg or 1000 mg paracetamol, and paracetamol 500 mg prolonged release tablet.
Mednje spadajo zdravila s paracetamolom kot edino učinkovino, in sicer tablete s prirejenim sproščanjem, ki vsebujejo 500 mg, 665 mg ali 1000 mg paracetamola, in tablete s podaljšanim sproščanjem s 500 mg paracetamola.
Overall, the measures proposed were considered neither sufficient nor appropriate to adequately minimise the risk of intentional and unintentional overdose.
Na splošno so bili predlagani ukrepi ocenjeni kot nezadostni in neprimerni za ustrezno zmanjšanje tveganja za namerno in nenamerno preveliko odmerjanje.
The PRAC also considered that the above proposals would have a questionable feasibility and effectiveness and would not effectively address the risk of hepatotoxicity following intentional or accidental overdose.
Odbor PRAC je menil tudi, da imajo zgornji predlogi vprašljivo izvedljivost in učinkovitost ter da ne bi učinkovito obravnavali tveganja za hepatotoksičnost po namernem ali nenamernem prevelikem odmerjanju.
Further, the feasibility of determining and implementing effective measures across EU Member States is questioned, due to the complexity of managing two specific protocols, a close monitoring (increased blood sampling) and the complexity due to the uncertainty on the ingested formulation that is prejudicial to the patient in view of the risk of not using an effective protocol and the safety concern related to the unnecessary administration of NAC.
Tudi izvedljivost ugotavljanja in uvajanja učinkovitih ukrepov v vseh državah članicah EU je vprašljivo, in sicer zaradi zapletenosti vodenja dveh posebnih protokolov, skrbnega spremljanja (večkratnih odvzemov krvi) in zapletenosti, ki je posledica negotovosti glede zaužitega formulacije, ki je bistvenega pomena za bolnika v smislu tveganja, da ne bo uporabljen učinkovit protokol, ter varnostnih pomislekov, povezanih z nepotrebnim dajanjem NAC.
Seven of the eleven patients with an ALT above the reference range were treated with NAC within 8 h of ingestion, of which three developed hepatotoxicity.
Sedem od enajstih bolnikov z vrednostjo ALT nad referenčnim razponom so z NAC zdravili v osmih urah po zaužitju, hepatotoksičnost pa se je pojavila pri treh.
On 30 June 2016, Sweden triggered a procedure under Article 31 of Directive 2001/83/EC, and asked the PRAC to assess the impact of the above concerns on the benefit-risk balance of products with modified or prolonged release properties containing paracetamol and issue a recommendation on whether the marketing authorisation(s) of these products should be maintained, varied, suspended or revoked.
Švedska je 30. junija 2016 sprožila postopek v skladu s členom 31 Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni vpliv zgornjih pomislekov na razmerje med tveganji in koristmi zdravil s prirejenim ali podaljšanim sproščanjem, ki vsebujejo paracetamol, ter izda priporočilo, ali naj se dovoljenje(-a) za promet z zdravilom ohrani(-jo), spremeni(-jo), začasno umakne(-jo) ali prekliče(-jo).
All these uncertainties and the identified disadvantages for patients having taken a paracetamol overdose, seriously question the feasibility and reliability in the recommendations proposed by the MAHs.
Vse navedene negotovosti in prepoznane slabosti pri bolnikih, ki vzamejo prevelik odmerek paracetamola, resno postavljajo pod vprašaj izvedljivost in zanesljivost priporočil, ki sta jih predlagala imetnika dovoljenj za promet z zdravilom.
Paracetamol is the most commonly reported toxic ingestion of a medical substance in the UK and some other EEA countries (e.g. Sweden) and is the most common medicinal agent of intentional self-harm.
Paracetamol je učinkovina, za katero v Združenem kraljestvu in nekaterih drugih državah EGP (npr. na Švedskem) najpogosteje poročajo o toksičnem zaužitju, in je najpogostejša učinkovina za namerno samopoškodovanje.
Due to the difference in the severity of conditions, there is a possibility of difference in the risk of suicidality between these two populations of patients using this fixed-dose combination with tramadol versus the MR paracetamol as monocomponent.
Zaradi razlike v resnosti stanj obstaja možnost razlike v tveganju za samomorilnost med tema dvema populacijama bolnikov, ki uporabljata kombinacijo s fiksnim odmerkom s tramadolom v primerjavi z monokomponentnim paracetamolom s prirejenim sproščanjem.
The shortcomings of Rumack-Matthew nomogram have already been identified thus leading to different treatment protocols in case of co-ingestion of other products (particularly those who affect gastric motility) or in cases when no information can be obtained from the patients (e.g. time of ingestion is unknown).
Pomanjkljivosti Rumack-Matthewovega nomograma so že bile prepoznane, zato že obstajajo nadomestni protokoli zdravljenja za primere sočasnega zaužitja drugih zdravil (zlasti tistih, ki vplivajo na želodčno gibljivost) ali primere, kadar od bolnikov ni mogoče pridobiti nobenih informacij (npr. neznan čas zaužitja).
It is acknowledged by PRAC that MR formulation may provide adequate control of pain and fewer dosing decreases the possibility for medication errors and improves patients' compliance.
Odbor PRAC je priznal, da formulacija s prirejenim sproščanjem lahko zagotovi ustrezen nadzor nad bolečino, manjše število odmerjanj pa zmanjšuje možnost za napake pri jemanju zdravila in izboljšuje bolnikovo sodelovanje pri zdravljenju.
Most countries have adopted guidelines which rely on a nomogram to establish whether the patient should be treated with NAC or not, relating the serum paracetamol concentration to the number of hours between ingestion and the blood test.
V večini držav so sprejeli smernice, ki pri ugotavljanju, ali je treba bolnika zdraviti z NAC ali ne, temeljijo na nomogramu, pri katerem so koncentracije paracetamola v serumu povezane s številom ur, ki so pretekle med zaužitjem in krvno preiskavo.
This included the responses submitted by the marketing authorisation holders (MAHs) in writing and during oral explanations, the grounds for the re-examination as submitted by the two concerned MAHs, as well as the advice from the two groups of experts in the management of poisoning, pain management and pharmacokinetics, published studies and spontaneous reports of overdose.
To je vključevalo odgovore, ki sta jih pisno in med ustno obrazložitvijo predložila imetnika dovoljenj za promet z zdravilom, razloge za ponovno proučitev, kot sta jih predložila zadevna imetnika dovoljenj za promet z zdravilom, ter nasvet dveh skupin strokovnjakov za zdravljenje zastrupitve, obvladovanje bolečine in farmakokinetiko, objavljene študije in spontana poročila o prevelikem odmerjanju.
This translates into different PK profiles also at overdoses which is supported by available data including published case series.
To pomeni, da so farmakokinetični profili tudi pri prevelikem odmerjanju drugačni, kar podpirajo razpoložljivi podatki, vključno z objavljenim nizom primerov.