natgillin/translations-raw huggingface dataset:
The CHMP noted that safety was less of a concern for the parenteral form, because these medicines are only given in a hospital setting where there is a lower risk of overdose. 
CHMP je ugotovil, da varnost ne pomeni tolikšnega zadržka pri parenteralni obliki, saj se ta zdravila dajejo le v bolnišnicah, kjer je tveganje prekomernega odmerjanja manjše.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of all medicines containing dextropropoxyphene, either on its own or in combination, do not outweigh their risks. 
Na osnovi ovrednotenja trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi vseh zdravil, vsebujočih dekstropropoksifen, dajanih samostojno ali v kombinaciji, ne odtehtajo z njimi povezanih tveganj.
It has been available as a prescription-only medicine for about 40 years, both on its own and in combination, as tablets, capsules, suppositories and solutions for injection. 
Približno 40 let je na voljo kot zdravilo, ki se izdaja samo na recept, in sicer bodisi samostojno bodisi v kombinaciji kot tablete, kapsule, svečke in raztopine za injiciranje.
There have been concerns for some years over the risk of death from overdose - both intentional and accidental - in patients taking medicines containing dextropropoxyphene and paracetamol. 
Pomisleki glede tveganja smrti zaradi prekomernega odmerka - namernega in nenamernega - pri bolnikih, ki jemljejo zdravila, vsebujoča dekstropropoksifen in paracetamol so prisotni že nekaj let.
For long-term pain, the Committee noted that there is no evidence that dextropropoxyphene and paracetamol is more effective than alternative painkillers. 
Pri dolgotrajni bolečini je Odbor ugotovil, da ni dokazov za to, da sta dekstropropoksifen in paracetamol učinkovitejša od alternativnih zdravil proti bolečini.
Why was dextropropoxyphene reviewed? 
Zakaj je bil dekstropropoksifen pregledan?
The full extent of the risks of dextropropoxyphene-containing medicine only became apparent when looking at complete forensic data and national mortality statistics, including toxicology data. 
Celoten obseg tveganj z zdravili, ki vsebujejo dekstropropoksifen, je postal razviden šele ob pregledu vseh forenzičnih podatkov in nacionalnih statistik umrljivosti, vključno s toksikološkimi podatki.
In terms of safety, the major concern of the Committee was the ‘narrow therapeutic index' of dextropropoxyphene. 
Z vidika varnosti je bil glavni pomislek Odbora ozek terapevtski indeks dekstropropoksifena.
Following the re-examination, the Committee confirmed that the benefits of non-parenteral forms of dextropropoxyphene-containing medicines do not outweigh their risks and recommended their withdrawal. 
Po ponovni presoji je Odbor potrdil, da koristi neparenteralnih oblik zdravil, vsebujočih dekstropropoksifen, ne odtehtajo z njimi povezanih tveganj, zato je priporočil njihov umik.
• Prescribers should be aware that the availability of dextropropoxyphene-containing medicines will decrease as the withdrawal takes place according to national timeframes. 
• Zdravniki, ki predpisujejo zdravila, se morajo zavedati, da se bo razpoložljivost zdravil, ki vsebujejo dekstropropoksifen, zmanjšala, ko bo prišlo do umika v skladu z nacionalnimi časovnimi okvirji.
The available evidence suggests that the combination of dextropropoxyphene and paracetamol is no more effective than paracetamol on its own, or ibuprofen, for short-term pain. 
Razpoložljivi dokazi kažejo, da kombinacija dekstropropoksifena in paracetamola pri kratkotrajni bolečini ni nič bolj učinkovita kot paracetamol, dajan samostojno, ali ibuprofen.
What are the recommendations for prescribers? 
Kakšna so priporočila za zdravnike, ki predpisujejo zdravila?
During the re-examination, the CHMP looked again at the data it had previously received, taking into consideration the different forms of dextropropoxyphene-containing medicines. 
Med ponovno presojo je CHMP ponovno pregledal podatke, ki jih je prejel predhodno, in proučil različne oblike zdravil, vsebujočih dekstropropoksifen.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of dextropropoxyphene do not outweigh its risks, and recommended that all marketing authorisations for dextropropoxyphene-containing medicines should be withdrawn throughout the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi dekstropropoksifena ne odtehtajo tveganj, zato je priporočil umik vseh dovoljenj za promet z zdravili, ki vsebujejo dekstropropoksifen, v Evropski uniji (EU).
What is dextropropoxyphene? 
Kaj je dekstropropoksifen?
The CHMP also concluded that data from several Member States, specifically those from forensic centres and national mortality statistics, showed a significant number of deaths associated with overdose in patients taking dextropropoxyphene. 
Odbor CHMP je zaključil tudi, da so podatki iz več držav članic, zlasti podatki iz forenzičnih centrov in nacionalnih statistik umrljivosti, pokazali, da je veliko število smrti povezanih s prekomernim odmerjanjem pri bolnikih, ki jemljejo dekstropropoksifen.
The CHMP concluded that the available data showed that dextropropoxyphene-containing medicines were weak painkillers, and only have limited effectiveness in the treatment of pain. 
CHMP je na podlagi razpoložljivih podatkov zaključil, da so zdravila, ki vsebujejo dekstropropoksifen, šibka zdravila proti bolečinam ter da so zgolj omejeno učinkovita pri lajšanju bolečin.
The CHMP noted that data from case reports of fatal overdose and from national poison centres underestimate the number of deaths from overdose with dextropropoxyphene-containing medicines. 
CHMP je ugotovil, da podatki iz poročil o posameznih primerih prekomernega odmerjanja s smrtnim izidom in nacionalnih centrov za zastrupitve podcenjujejo število smrti zaradi prekomernega odmerjanja zdravil, ki vsebujejo dekstropropoksifen.
• Prescribers should carefully consider the best alternative treatments for patients currently taking dextropropoxyphene-containing medicines in line with national recommendations. 
• Zdravniki, ki predpisujejo zdravila, morajo skrbno izbrati najboljše alternativno zdravilo za bolnike, ki trenutno prejemajo zdravila, vsebujoča dekstropropoksifen, v skladu z nacionalnimi priporočili.
The CHMP initially reviewed data presented by the companies that market dextropropoxyphenecontaining medicines, providing information on the efficacy and the safety of their medicines. 
CHMP je najprej pregledal podatke, predložene s strani družb, ki dajejo v promet zdravila, vsebujoča dekstropropoksifen, vključno z informacijami o učinkovitosti in varnosti zdravil, ki jih dajejo v promet.
In the meantime, it is recommended that no new patients are started on dextropropoxyphene-containing medicines. 
Priporočljivo je, da medtem novi bolniki ne začenjajo jemati zdravil, ki vsebujejo dekstropropoksifen.
• Patients who have any dextropropoxyphene-containing medicines that they are no longer using are encouraged to take them to their pharmacist for safe disposal. 
• Bolniki, ki imajo doma zdravila, vsebujoča dekstropropoksifen, in jih ne uporabljajo več, naj jih prinesejo k farmacevtu, da se zagotovi njihova varna odstranitev.
• Patients who are currently receiving dextropropoxyphene-containing medicines should speak to their doctor at their next appointment to review their treatment. 
• Bolniki, ki trenutno prejemajo zdravila, ki vsebujejo dekstropropoksifen, se morajo ob naslednjem obisku o tem pogovoriti s svojim zdravnikom, da jim določi nadaljnji potek zdravljenja.
Data assessed by the Committee highlighted that many of the cases of fatal overdoses seen have been accidental. 
Podatki, ki jih je Odbor ocenil, so pokazali, da so številni primeri prekomernega odmerjanja s smrtnim izidom, nenamerni.
The CHMP therefore recommended that the marketing authorisations for the parenteral form of dextropropoxyphene-containing medicines be suspended until further data are available to show that the benefits outweigh the risks. 
CHMP je zato priporočil zadržanje dovoljenj za promet s parenteralno obliko zdravil, ki vsebujejo dekstropropoksifen, dokler nadaljnji podatki ne bodo pokazali, da koristi odtehtajo z njimi povezana tveganja.
At the request of the marketing authorisation holders, the CHMP re-examined its opinion. 
CHMP je na zahtevo imetnikov dovoljenja za promet z zdravili ponovno pregledal svoje mnenje.
What were the conclusions of the CHMP following the re-examination? 
Do kakšnih zaključkov je prišel CHMP po ponovni presoji?
The European Commission granted a marketing authorisation valid throughout the European Union for Metalyse on 23 February 2001. 
Evropska komisija je dovoljenje za promet z zdravilom Metalyse, veljavno po vsej Evropski uniji, izdala 23. februarja 2001.
The main measure of effectiveness was the number of patients who were alive 30 days after treatment. 
Glavno merilo učinkovitosti je bilo število bolnikov, ki so 30 dni po prejemu zdravljenja še živeli.
The full EPAR for Metalyse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Metalyse je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Metalyse: 
Druge informacije o zdravilu Metalyse:
This document is a summary of the European Public Assessment Report (EPAR) for Metalyse. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Metalyse.
Around 94% of patients who received either medicine were alive 30 days after treatment. 
Približno 94 % bolnikov, ki so prejeli katero koli od obeh zdravil so 30 dni po prejemu zdravila še živeli.
Based on this and all other available data, the Committee decided that Metalyse's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Na podlagi te ugotovitve in drugih razpoložljivih podatkov je zaključil, da so koristi zdravila Metalyse večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Tenecteplase is made by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it. 
Tenekteplaza se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“: izdela jo celica, ki je prejela gen (DNK), s katerim jo lahko tvori.
Treatment with Metalyse should be started as soon as possible after the start of heart attack symptoms. 
Zdravljenje z zdravilom Metalyse je treba začeti čim prej po pojavu simptomov srčnega napada.
For more information about treatment with Metalyse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Metalyse preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP noted that while Metalyse was as effective as alteplase in preventing death, it caused less serious bleeding, which meant that fewer blood transfusions were required. 
CHMP je ugotovil, da je zdravilo Metalyse enako učinkovito kot alteplaza pri preprečevanju smrti, a povzroča manj resne krvavitve, kar pomeni, da je potrebnih manj infuzij krvi.
What benefit has Metalyse shown during the studies? 
Kakšne koristi je zdravilo Metalyse izkazalo med študijami?
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 use for Metalyse. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
If treatment is necessary in these patients, facilities for resuscitating them must be readily available. 
Če je uporaba zdravila vseeno potrebna, mora biti na voljo oprema za oživljanje.
With the blood clot broken down, blood can flow more easily into the heart muscle, allowing the heart to keep working and helping to save the patient's life. 
Po razgraditvi strdka kri lažje steče v srčno mišico, kar srcu omogoča nadaljnje delovanje, bolniku pa možnost preživetja.
It is used to dissolve the blood clots that have formed inside the blood vessels supplying the heart. 
Uporablja se za razgradnjo krvnih strdkov, nastalih znotraj krvnih žil, ki oskrbujejo srce.
In addition to Metalyse, the patient should also be treated with other medicines that are used to prevent blood clots such as aspirin and heparin. 
Poleg zdravila Metalyse je treba pri bolniku uporabiti tudi druga zdravila, ki preprečujejo nastajanje krvnih strdkov, kot sta aspirin in heparin.
Metalyse was as effective as alteplase in keeping patients alive after a heart attack. 
Zdravilo Metalyse je bilo enako učinkovito kot alteplaza pri preživetju bolnikov po srčnem napadu.
What is the risk associated with Metalyse? 
Kakšna tveganja so povezana z zdravilom Metalyse?
Metalyse is a powder and a solvent that are made up into a solution for injection. 
Zdravilo Metalyse je prašek in vehikel za pripravo raztopine za injiciranje.
Metalyse should be prescribed by doctors who have experience in the use of thrombolytic treatments (treatments to dissolve blood clots). 
Zdravilo Metalyse morajo predpisati zdravniki, ki imajo izkušnje z trombolitičnimi zdravili (zdravili, ki razgrajujejo krvne strdke).
It works by converting a protein in the clots called plasminogen into its active form, plasmin, which breaks down the fibrous protein holding the clot together. 
Deluje tako, da beljakovino v strdku, imenovano plazminogen, pretvori v njegovo aktivno obliko, tj. plazmin, ki razgradi fibrinsko beljakovino, odgovorno za strdek.
Metalyse should not be used in patients who have or have had recent bleeding problems or major surgery, or have a disease which may cause bleeding (such as a past stroke or severe high blood pressure). 
Zdravila Metalyse prav tako ne smejo prejeti bolniki, ki imajo ali so pred nedavnim imeli težave s krvavitvijo ali večjo operacijo, ali imajo bolezenske težave, ki lahko povzročijo krvavitev (kot je nedavna kap ali močno povišan krvni tlak).
Metalyse is given once as a single injection into a vein over around 10 seconds. 
Daje se z eno injekcijo v veno v trajanju približno 10 sekund.
Metalyse is used to treat adults suspected of having an acute myocardial infarction (heart attack) within six hours of the first symptoms appearing. 
Zdravilo Metalyse se uporablja za zdravljenje odraslih, pri katerih obstaja sum za akutni miokardni infarkt (srčni napad) in se daje v 6 urah po pojavu prvih simptomov.
Metalyse should not be used in people who have had an anaphylactic reaction (a severe, lifethreatening allergic reaction) to tenecteplase, gentamicin (an ingredient found in the medicine) or any of the other ingredients. 
Zdravilo Metalyse se ne sme uporabljati pri ljudeh, ki so imeli v preteklosti anafilaktično reakcijo (hudo, življenje ogrožajočo alergijsko reakcijo) na tenekteplazo, gentamicin (sestavino zdravila) ali katero koli drugo sestavino zdravila.
For the full list of all side effects reported with Metalyse, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Metalyse, glejte navodilo za uporabo.
The active substance in Metalyse, tenecteplase, is a modified copy of the human enzyme ‘tissue plasminogen activator', which the body uses to break down clots. 
Zdravilna učinkovina v zdravilu Metalyse, tenekteplaza, je spremenjena kopija človeškega encima, in sicer tkivnega plazminogenskega aktivatorja, ki ga telo uporablja za razgradnjo krvnih strdkov.
Why has Metalyse been approved? 
Zakaj je bilo zdravilo Metalyse odobreno?
It contains the active substance tenecteplase. 
Vsebuje zdravilno učinkovino tenekteplazo.
The most common bleedings (seen in between 1 and 10 patients in 100) are epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), ecchymosis (bleeding beneath the skin), urogenital haemorrhage (bleeding from the structures that carry urine or from the genital area), bleeding at the injection site, and bleeding at puncture site. 
Največkrat se je pojavila epistaksa (krvavitev iz nosu), gastrointestinalna hemoragija (krvavitev v želodcu ali črevesju), ekhimoza (podkožna krvavitev), urogenitalna hemoragija (krvavitev v sečilih ali genitalnem predelu) ter krvavitev na mestu injiciranja ali mestu punkcije.
The dose to be given is adjusted according to the patient's weight (see the package leaflet). 
Odmerek je treba prilagoditi glede na bolnikovo telesno maso (glejte navodila za uporabo).
Metalyse was compared with alteplase (another medicine used to treat heart attacks) in one main study involving about 17,000 adults who were having a heart attack. 
Zdravilo Metalyse so v eni glavni študiji, v katero je bilo vključenih 17 000 odraslih s srčnim napadom, primerjali z alteplazo (drugim zdravilom, ki se uporablja pri srčnem napadu).
The most common side effect with Metalyse was haemorrhage (bleeding). 
Najpogostejši neželeni učinek zdravila Metalyse so bile krvavitve.
The patients were given either medicine within six hours of their symptoms appearing in addition to either aspirin or heparin. 
Bolniki so poleg aspirina ali heparina prejeli eno ali drugo zdravilo v šestih urah po pojavu simptomov.
What is Metalyse used for? 
Za kaj se zdravilo Metalyse uporablja?
How has Metalyse been studied? 
Kako je bilo zdravilo Metalyse raziskano?
How does Metalyse work? 
Kako zdravilo Metalyse deluje?
What is Metalyse? 
Kaj je zdravilo Metalyse?
How is Metalyse used? 
Kako se zdravilo Metalyse uporablja?
• The schedule of follow-up of patients 
• urnik nadaljnjega spremljanja bolnikov
• The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C, 
• potrebo po testiranju darovalcev z uporabo vprašalnikov laboratorijskih preskusov za hepatitis C,
The Marketing Authorisation Holder (MAH) shall ensure that the medicinal product will be distributed only to Healthcare Establishments that meet criteria described in the Risk Management Plan. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da se zdravilo priskrbi le zdravstvenim ustanovam, ki izpolnjujejo merila, opisana v načrtu za obvladovanje tveganj.
• The handling of ChondroCelect and its preparation for the implantation 
• ravnanje z zdravilom ChondroCelect in njegova priprava za implantacijo
The educational programme for healthcare professionals contains the following components: 
Izobraževalni program za zdravstvene delavce vsebuje:
• The surgical checklist to be completed at the operating theatre immediately prior to the first incision confirming the right patient, the right product, the right side of the implantation, and the type of biological membrane and fibrin sealant to be used in the procedure. 
• kirurški kontrolni seznam, ki se izpolni v operacijski dvorani tik pred prvim vrezom, s katerim se potrdi bolnikova identiteta, ustreznost zdravila, ustreznost predela implantacije in vrsta biološke membrane ter fibrinskega sredstva za zapiranje ran, ki se uporabi med posegom.
• Training material for other Healthcare Professionals • Informed consent for the patients to be signed prior to the treatment with ChondroCelect 
• gradivo za usposabljanje drugih zdravstvenih delavcev • privolitev bolnikov, ki s podpisom zagotovijo, da se seznanjeni z zdravljenjem z zdravilom
The training material for other Healthcare Professionals shall include the following key messages and components: 
Gradivo za usposabljanje drugih zdravstvenih delavcev mora vsebovati naslednje ključne podatke in elemente:
• The implantation procedure by knee-joint arthrotomy 
• postopek implantacije z artrotomijo kolenskega sklepa
The Marketing Authorisation Holder (MAH) shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that all surgeons and other healthcare professionals involved in the handling and administration of ChondroCelect or its components, as well as those involved in follow-up of patients treated with ChondroCelect in the Healthcare Establishment, receive training as per the educational programme described in the Risk Management Plan. 
Imetnik dovoljenja za promet z zdravilom mora določeni zdravstveni ustanovi pred dobavo zdravila po izobraževalnem programu, ki je opisan v načrtu za obvladovanje tveganj zagotoviti usposabljanje vseh kirurgov in drugih zdravstvenih delavcev, ki uporabljajo in dajejo zdravilo ChondroCelect ali njegove sestavine, ter vseh, ki sodelujejo pri nadaljnjem spremljanju bolnikov, zdravljenih z zdravilom ChondroCelect v zdravstveni ustanovi.
• The handling of the biopsy harvest 
• ravnanje z odvzetim tkivom po biopsiji
The training materials for Surgeons shall include the following key messages and components: 
Gradivo za usposabljanje kirurgov mora vsebovati naslednje ključne podatke in elemente: • povzetek glavnih značilnosti zdravila
This summary was last updated in 01-2011. 
Povzetek je bil nazadnje posodobljen 01-2011.
The vaccination schedule to be used depends on the age of the child and should be based on official 
Shema cepljenja, ki se bo uporabila, je odvisna od starosti otroka in mora temeljiti na uradnih
Prevenar is a vaccine. 
Zdravilo Prevenar je cepivo.
The full EPAR for Prevenar can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prevenar je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The additional studies showed that Prevenar was safe and effective in children up to the age of five years. 
Dodatne študije so pokazale, da je zdravilo Prevenar varno in učinkovito pri otrocih do petega leta starosti.
This is a summary of the European public assessment report (EPAR) for Prevenar. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prevenar.
What benefit has Prevenar shown during the studies? 
Kakšne koristi je zdravilo Prevenar izkazalo med študijami?
For more information about treatment with Prevenar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Prevenar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
What is the risk associated with Prevenar? 
Kakšna tveganja so povezana z zdravilom Prevenar?
The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S.A. on 2 February 2001. 
Evropska komisija je dovoljenje za promet z zdravilom Prevenar, veljavno po vsej Evropski uniji, odobrila družbi Wyeth Lederle Vaccines S.A. dne 2. februarja 2001.
In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five 
Po evropskih ocenah so ti serotipi odgovorni za približno 54 % do 84 % invazivnih okužb (okužb, ki so se razširile po telesu) dojenčkov in otrok, ki so mlajši od dveh let, in približno 62 % do 83 % invazivnih okužb otrok, ki so stari med dvema in pet let.
Pneumococcal saccharide conjugated vaccine, adsorbed 
konjugirano pnevmokokno saharidno cepivo, adsorbirano
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 use for 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Prevenar, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede