natgillin/translations-raw huggingface dataset:
The standard dose of Clopidogrel HCS is one 75-mg tablet once a day. 
Običajni odmerek zdravila Clopidogrel HCS je ena 75-miligramska tableta enkrat dnevno.
In acute coronary syndrome, treatment generally starts with a loading dose of four tablets. 
Pri akutnem koronarnem sindromu se zdravljenje načeloma uvede z udarnim odmerkom štirih tablet.
This means that Clopidogrel HCS is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix. 
To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke. 
To preprečuje, da bi trombociti postali lepljivi, ter tako zmanjšuje tveganje za nastanek krvnih strdkov in prispeva k preprečitvi novega srčnega napada ali kapi.
For more information about treatment with Clopidogrel HCS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Clopidogrel HCS preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is then followed by the standard 75mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in unstable angina or non-Q-wave myocardial infarction). 
Temu sledi običajni 75-miligramski odmerek enkrat na dan za najmanj štiri tedne (pri miokardnem infarktu z elevacijo spojnice ST) ali največ 12 mesecev (pri nestabilni angini pektoris ali pri miokardnem infarktu brez zobca Q).
It is used in patients who have at least one risk factor for events such as a heart attack or stroke, cannot take vitamin-K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding. 
Uporablja se pri bolnikih, ki imajo vsaj en dejavnik tveganja za dogodke, kot so srčni napad ali kap, ki ne smejo jemati antagonistov vitamina K (drugih zdravil, ki preprečujejo krvne strdke) in pri katerih je tveganje za krvavitve majhno.
The full EPAR for Clopidogrel HCS can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel HCS je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Clopidogrel HCS can be started between a few days and 35 days after the attack; 
Zdravilo se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
Because Clopidogrel HCS is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as those of the reference medicine's. 
Ker je zdravilo Clopidogrel HCS generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel HCS can be used in patients who are having a heart attack with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment. 
Zdravilo Clopidogrel HCS se lahko uporablja pri bolnikih, ki so doživeli srčni napad z elevacijo spojnice ST (nenormalnim zapisom na EKG ali elektrokardiogramu), če zdravnik meni, da bi jim zdravilo pomagalo.
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 Clopidogrel HCS. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel HCS, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What are the benefits and risks of Clopidogrel HCS? 
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel HCS?
Clopidogrel HCS can be given to the following groups of patients: 
Zdravilo se lahko daje naslednjim skupinam bolnikov:
• patients with acute coronary syndrome (a condition in which blood supply to the heart is reduced), when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up). 
• bolnikom z akutnim koronarnim sindromom (bolezenskim stanjem, za katerega je značilen zmanjšan dotok krvi v srce) , pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov), vključno z bolniki, ki jim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zamašitev).
The Committee recommended that Clopidogrel HCS be given marketing authorisation. 
Odbor je zato priporočil, da se za zdravilo Clopidogrel HCS izda dovoljenje za promet.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction. 
Lahko se uporablja tudi pri bolnikih, ki nimajo nenormalnega zapisa na EKG, če imajo nestabilno angino pektoris (hudo obliko bolečine v prsih) ali so doživeli miokardni infarkt brez zobca Q.
Because Clopidogrel HCS is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. 
Ker je zdravilo Clopidogrel HCS generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
• patients with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin. 
• bolnikom z atrijsko fibrilacijo (nerednim hitrim krčenjem srčnih preddvorov), pri katerih se mora dajati skupaj z aspirinom.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel HCS has been shown to have comparable quality and to be bioequivalent to Plavix. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel HCS primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Plavix, odtehtajo znana tveganja.
Clopidogrel HCS can be started between seven days and six months after the stroke; 
Zdravilo se lahko začne jemati od sedem dni po kapi do šest mesecev po njej;
• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). 
• bolnikom, ki so nedavno doživeli ishemično kap (kap, ki jo povzroči prekinitev dotoka krvi v del možganov).
Clopidogrel HCS is a blood-thinning medicine that contains the active substance clopidogrel. 
Clopidogrel HCS je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel HCS, clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Clopidogrel HCS, klopidogrel, je zaviralec agregacije trombocitov.
Other information about Clopidogrel HCS 
Druge informacije o zdravilu Clopidogrel HCS
Clopidogrel HCS is a ‘generic medicine'. 
Zdravilo Clopidogrel HCS je generično zdravilo.
Why has Clopidogrel HCS been approved? 
Zakaj je bilo zdravilo Clopidogrel HCS odobreno?
What is Clopidogrel HCS? 
Kaj je zdravilo Clopidogrel HCS?
What is Clopidogrel HCS used for? 
Za kaj se zdravilo Clopidogrel HCS uporablja?
How has Clopidogrel HCS been studied? 
Kako je bilo zdravilo Clopidogrel HCS raziskano?
How does Clopidogrel HCS work? 
Kako zdravilo Clopidogrel HCS deluje?
How is Clopidogrel HCS used? 
Kako se zdravilo Clopidogrel HCS uporablja?
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for tetrazepam-containing medicinal product(s) 
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Luxembourg Will Pharma S.A. Monplaisirlaan 33 
Luksemburg Will Pharma S.A. Monplaisirlaan 33
Luxembourg Eurogenerics NV Heizel Esplanade b22 
Luksemburg Eurogenerics NV Heizel Esplanade b22
Luxembourg Sanofi Aventis Belgium N.V Culliganlaan 1C 
Luksemburg Sanofi Aventis Belgium N.V Culliganlaan 1C
ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Poljska ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Tetrazepamratiopharm 50 mg Filmtabletten 
Tetrazepam-ratiopharm 50 mg Filmtabletten
22 October 2009 
20. april 2011
Why were these medicines reviewed? 
Zakaj so bila ta zdravila pregledana?
See: http://www.who.int/cancer/palliative/painladder/en/. 
Glejte: http://www.who.int/cancer/palliative/painladder/en/.
Some information was also available from studies in human volunteers. 
Nekaj informacij je bilo na voljo tudi iz študij pri prostovoljcih.
These are called ‘controlled-release systems'. 
Te se imenujejo „sistemi za nadzorovano sproščanje“.
They should take note of the restrictions and warnings for the medicines that they are using. 
Upoštevati morajo omejitve in opozorila za zdravila, ki jih uporabljajo.
• Patients who have any questions should speak to their doctor or pharmacist. 
• Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravnikom ali farmacevtom.
Which data has the CHMP reviewed? 
Katere podatke je pregledal CHMP?
These included patients with late-stage cancer. 
Te so vključevale bolnike z rakom v poznem stadiju.
What are the recommendations for patients and prescribers? 
Kakšna so priporočila za bolnike in zdravnike, ki predpisujejo zdravila?
The full changes made to the information to doctors and patients are detailed here. 
Vse spremembe v informacijah za zdravnike in bolnike so na voljo tukaj.
They looked at seven different systems used with morphine, two used with hydromorphone and four used with oxycodone. 
Pregledali so sedem različnih sistemov, ki so se uporabljali z morfinom, dva s hidromorfonom in štiri z oksikodonom.
When these capsules were put into a 20% alcohol solution, 80% of the active substance was released within 15 minutes. 
Ko so te kapsule položili v 20-odstotno raztopino alkohola, se je 80 % zdravilne učinkovine sprostilo v 15 minutah.
This means that almost a full day's dose of morphine would be released all at once if a patient were to take the capsule with large drink of neat strong liquor, such as whisky or vodka. 
To pomeni, da bi se naenkrat sprostil skoraj celodnevni odmerek morfina, če bi bolnik kapsulo vzel z večjo količino močne alkoholne pijače, na primer viskijem ali vodko.
‘Modified-release' forms of these medicines release the active substance slowly, often over many hours. 
Oblika teh zdravil s „prirejenim sproščanjem“ sprošča zdravilno učinkovino počasi, pogosto več ur.
Therefore, the Committee recommended that the warnings on this interaction be made consistent in the information for doctors and patients across all oral opioid medicines of the WHO level III scale. 
Odbor je zato priporočil, da se opozorila o tem medsebojnem delovanju dosledno navedejo v informacijah za zdravnike in bolnike za vsa peroralna opioidna zdravila III. stopnje po lestvici SZO.
There are over 500 different medicines belonging to the WHO level III scale group authorised in European Union (EU) Member States. 
V državah članicah Evropske unije (EU) je odobrenih več kot 500 različnih zdravil iz skupine zdravil III. stopnje po lestvici SZO.
The CHMP noted that the use of this medicine in combination with alcohol is already contra-indicated. 
CHMP je ugotovil, da je uporaba tega zdravila v kombinaciji z alkoholom že kontraindicirana.
For all other medicines in this class, the Committee concluded that their benefits continue to outweigh their risks, and therefore recommended that their marketing authorisations be maintained. 
Za vsa druga zdravila v tej skupini je Odbor sklenil, da njihove koristi še vedno odtehtajo z njimi povezana tveganja in zato priporočil, da se dovoljenja za promet s temi zdravili ohranijo.
They include morphine and the related medicines oxycodone and hydromorphone, all of which work by attaching to receptors in the brain and spinal cord to prevent pain. 
Vključujejo morfin ter sorodni zdravili oksikodon in hidromorfon, ki delujejo tako, da se vežejo na receptorje v možganih in hrbtenjači ter tako preprečujejo bolečino.
Consequently, the European Commission asked the CHMP to carry out an assessment of the benefitrisk balance of these medicines, concentrating on their interaction with alcohol, and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU. 
Zato je Evropska komisija CHMP zaprosila, da izvede oceno razmerja med tveganji in koristmi teh zdravil s poudarkom na medsebojnem delovanju z alkoholom in da izda mnenje, ali naj se dovoljenja za promet z zdravili po vsej EU ohranijo, spremenijo, začasno umaknejo ali ukinejo.
• Prescribers are reminded that there are a large number of modified-release opioids available in each Member State. 
• Zdravnike, ki predpisujejo zdravila, je treba opomniti, da je v vsaki državi članici na voljo veliko število opioidov s prirejenim sproščanjem.
This is called ‘dose dumping' and could put patients at risk of exposure to large doses of the opioid, leading to side effects such as respiratory depression (an inhibition of breathing). 
Ta pojav se imenuje prekomerno sproščanje in zaradi njega so lahko bolniki izpostavljeni tveganju zaradi velikih odmerkov opioida, kar lahko povzroči neželene učinke, na primer respiratorno depresijo (zmanjšanje dihanja).
• Prescribers of modified-release opioids and their patients should be aware of the potential interaction between these medicines and alcohol. 
• Zdravniki, ki predpisujejo opioide s prirejenim sproščanjem, in njihovi bolniki se morajo zavedati možnega medsebojnega delovanja teh zdravil z alkoholom.
However, studies looking at the drinking behaviour of patients with severe pain show that many patients drink alcohol while being treated with strong opioids. 
Vendar pa so študije, v katerih so preučevali navade pitja pri bolnikih s hudo bolečino, pokazale, da veliko bolnikov pri zdravljenju z močnimi opioidi pije alkohol.
The CHMP used the results of these studies to predict what would happen if these medicines were taken with alcohol. 
CHMP je rezultate teh študij uporabil za napoved, kaj bi se zgodilo, če bi se ta zdravila jemala skupaj z alkoholom.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of most of these medicines continue to outweigh their risks, but that warnings on the use of these medicines together with alcohol should be made consistent across the class. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi večine teh zdravil še vedno odtehtajo z njimi povezana tveganja, vendar je treba za celotno skupino dosledno navajati opozorila glede uporabe teh zdravil skupaj z alkoholom.
break down slowly in the body or limit the active substance's release, such as cellulose-based substances and polymers. 
razgrajujejo ali omejujejo sproščanje zdravilne učinkovine, kot so snovi na osnovi celuloze in polimeri.
The CHMP also took information from studies looking at the drinking habits of patients with severe pain into account. 
CHMP je upošteval tudi informacije iz študij, v katerih so preučevali navade pitja pri bolnikih s hudimi bolečinami.
Because some of the chemicals used in the controlled-release systems dissolve in alcohol, there is a theoretical possibility that taking these medicines together with alcohol may cause the active substance to be released too quickly. 
Ker so nekatere od kemičnih snovi, ki se uporabljajo pri sistemih za nadzorovano sproščanje, topne v alkoholu, je teoretično mogoče, da bi jemanje teh zdravil skupaj z alkoholom lahko povzročilo prehitro sproščanje zdravilne učinkovine.
However, the CHMP noted that all medicines in this class have the potential to interact with alcohol, such as increasing the opioids' sedative effects. 
Vendar pa je CHMP tudi menil, da lahko vsa zdravila v tem razredu medsebojno delujejo z alkoholom, na primer povečajo pomirjevalni učinek opioidov.
Oral opioid medicines of the WHO level III scale for the management of pain are strong painkillers that are taken by mouth and used to treat intense pain that has not been controlled sufficiently with other medicines. 
Peroralna opioidna zdravila III. stopnje po lestvici SZO za obvladovanje bolečine so močna protibolečinska zdravila, ki se pogoltnejo in se uporabljajo za zdravljenje močne bolečine, ki je z drugimi zdravili ni mogoče ustrezno obvladovati.
These medicines were reviewed following concerns that alcohol might have an effect on the way they release the active substance in the body. 
Zdravila so bila pregledana po tem, ko so se pojavili zadržki, da lahko alkohol vpliva na način sproščanja zdravilne učinkovine v telesu.
These suspensions will remain in force until the companies that make these medicines have reformulated them so that they are more stable in alcohol. 
Začasni umiki bodo veljali, dokler družbe, ki proizvajajo ta zdravila, ne spremenijo njihovih formulacij tako, da bodo stabilnejša v alkoholu.
Therefore, the Committee recommended that the marketing authorisations for these medicines should be suspended until the companies that make these medicines have reformulated the medicines so that they are more stable in alcohol. 
Zato je Odbor priporočil, da se dovoljenja za promet s temi zdravili začasno umaknejo, dokler družbe, ki ta zdravila proizvajajo, ne spremenijo njihovih formulacij, tako da bodo stabilnejša v alkoholu.
The CHMP concluded that around half of the controlled-release systems tested showed a slight increase in the amount of active substance they released when placed in an alcohol solution, but that this effect was mild and would only have a minor effect on the release of the active substance. 
CHMP je ugotovil, da se je pri približno polovici testiranih sistemov za nadzorovano sproščanje pokazalo majhno povečanje količine zdravilne učinkovine, ki se je sprostila ob umestitvi sistemov v alkoholno raztopino, vendar pa je bil ta učinek blag in bi imel le majhen vpliv na sproščanje zdravilne učinkovine.
However, for one of the controlled-release systems tested - once-daily capsules using a polymethacrylate-triethylcitrate coating to control the release of morphine - there was a significant interaction with alcohol. 
Pri enem testiranem sistemu za nadzorovano sproščanje - kapsulah s prevleko iz polimetakrilat-trietilcitrata za nadzorovanje sproščanja morfina, ki se jemljejo enkrat na dan - pa se je pojavilo pomembno medsebojno delovanje z alkoholom.
This ladder gives recommendations on the order in which painkillers of increasing strength should be used to control a patient's pain1. 
Lestvica daje priporočila o tem, v kakšnem vrstnem redu glede na naraščajočo jakost se morajo pri bolnikih za obvladovanje bolečine uporabljati protibolečinska zdravila1.
The CHMP reviewed the results of laboratory studies looking at the way that controlled-release systems act when they are placed in solutions containing alcohol. 
CHMP je pregledal rezultate laboratorijskih študij, ki so preučevale način delovanja sistemov za nadzorovano sproščanje v primerih, kadar so postavljeni v raztopine z alkoholom.
Questions and answers on the review of modified-release oral opioid medicines of the WHO level III scale for the management of pain 
Vprašanja in odgovori glede pregleda peroralnih opioidnih zdravil s prirejenim sproščanjem III. stopnje po lestvici SZO za obvladovanje bolečine
Therefore, the CHMP concluded that modified-release opioids using the polymethacrylate-triethylcitrate controlled-release system are highly sensitive to alcohol and that there is a risk of dose dumping if patients drink alcohol while taking them. 
Zato je CHMP sklenil, da so opioidi s prirejenim sproščanjem, pri katerih se uporablja sistem za nadzorovano sproščanje s polimetakrilat-trietilcitratom, zelo občutljivi na alkohol in da obstaja tveganje prekomernega sproščanja, če bolniki ob jemanju teh opioidov pijejo alkohol.
However, for modified-release medicines that contain a ‘polymethacrylate-triethylcitrate controlled release system', the Committee concluded that the marketing authorisations should be suspended. 
Vendar pa je Odbor glede zdravil s prirejenim sproščanjem, ki vsebujejo „sistem za nadzorovano sproščanje s polimetakrilat-trietilcitratom“, sklenil, da je treba dovoljenja za promet z zdravilom začasno umakniti.
They are called ‘WHO level III scale' medicines as they are on the highest step of the World Health Organization's three-step pain relief ladder. 
stopnje po lestvici SZO“, saj so na najvišji stopnji tristopenjske lestvice Svetovne zdravstvene organizacije za lajšanje bolečin.
The European Medicines Agency has completed a review of the safety and effectiveness of modifiedrelease oral opioid medicines of the WHO level III scale for the management of pain. 
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti peroralnih opioidnih zdravil s prirejenim sproščanjem III. stopnje po lestvici SZO za obvladovanje bolečine.
They should consider switching patients currently taking opioids containing the polymethacrylate-triethylcitrate controlled-release system to alternatives while the suspension is in force. 
Upoštevati morajo, da je treba pri bolnikih, ki trenutno jemljejo opioide, ki vsebujejo sistem za nadzorovano sproščanje s polimetakrilat-trietilcitratom, v obdobju začasnega umika dovoljenja za promet te opioide zamenjati z nadomestnimi zdravili.
What are modified-release oral medicines of the WHO level III scale for the management of pain? 
Kaj so peroralna zdravila s prirejenim sproščanjem III. stopnje po lestvici SZO za obvladovanje bolečine?
A European Commission decision on this opinion will be issued in due course. 
Evropska komisija je odločbo izdala dne 20. aprila 2011.
Modifiedrelease tablets and capsules are made by combining the active substance with other substances that 
To zmanjša število odmerkov, ki jih mora bolnik vzeti vsak dan. Tablete in kapsule s prirejenim sproščanjem vsebujejo kombinacijo zdravilne učinkovine in drugih snovi, ki se v telesu počasi
Companies responses provided on: 25 January 2010, 4 May 2010 and 2 July 2010 Opinion date: 
Po ponovnem pregledu je Odbor dne 18. novembra 2010 ta priporočila potrdil.
Member State in EEA 
Država članica EU/EGP
Product name 
Izmišljeno ime
Pharmaceutical form Route of administration 
Farmacevtska oblika Pot uporabe zdravila
Human Medicines Evaluation Division 
Imetnik dovoljenja za promet z zdravilom
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for flupirtine-containing medicinal products 
Priloga I Seznam zdravil in oblik
Flupirtinmaleat Tamarang 
Flupirtinmaleat Tamarang flupirtinijev maleat 100 mg kapsula