natgillin/translations-raw huggingface dataset:
In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients experienced an ‘event' such as a blocked artery, another heart attack or death during the
V študijah akutnega koronarnega sindroma so vsi bolniki jemali tudi aspirin, glavno merilo učinkovitosti pa je bilo število bolnikov z „dogodkom“, kot je blokirana arterija, še en srčni napad ali smrt med samo študijo.
Clopidogrel BMS is converted into its active form in the body.
Zdravilo Clopidogrel BMS se v svojo aktivno obliko pretvori v telesu.
Clopidogrel BMS can be started between a few days and 35 days after the attack;
Zdravilo Clopidogrel BMS se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
Clopidogrel BMS is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Clopidogrel BMS se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
The most common side effects with Clopidogrel BMS (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Najpogostejši neželeni učinki zdravila Clopidogrel BMS (opaženi pri 1 do 10 bolnikih izmed 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), driska, bolečine v trebuhu, dispepsija (zgaga), podplutbe in krvavitve na mestu predrte kože.
In CAPRIE, there were 939 events in the Clopidogrel BMS group, and 1,020 in the aspirin group.
V študiji CAPRIE je bilo v skupini, ki je prejemala zdravilo Clopidogrel, 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1 020.
Clopidogrel BMS should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.
Zdravila Clopidogrel BMS ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila.
Clopidogrel BMS can be used in patients who are having a heart attack with an ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Zdravilo Clopidogrel BMS se lahko uporablja pri bolnikih, ki so imeli srčni napad z „elevacijo ST spojnice“ (nenormalni zapis na EKG ali elektrokardiogramu), če zdravnik meni, da bi jim zdravilo lahko pomagalo.
The Committee recommended that Clopidogrel BMS be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Clopidogrel BMS odobri dovoljenje za promet.
Clopidogrel BMS was more effective than aspirin at preventing new ischaemic events.
Zdravilo Clopidogrel BMS je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
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, pri katerih ni nenormalnega zapisa na EKG, če imajo nestabilno angino (hudo obliko bolečine v prsih) ali so imeli miokardni infarkt brez
• patients who have a condition known as ‘acute coronary syndrome', 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, pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov), vključno z bolniki, katerim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zapiranje).
Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Klopidogrel ustavi zlepljanje trombocitov tako, da spojini, imenovani ADP, preprečuje vezavo na posebne receptorje na njihovi površini.
Other information about Clopidogrel BMS:
Druge informacije o zdravilu Clopidogrel BMS:
Clopidogrel BMS has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral arterial disease.
Zdravilo Clopidogrel BMS so primerjali z aspirinom v študiji CAPRIE, v katero je bilo vključenih okoli 19 000 bolnikov, ki so nedavno doživeli srčni napad ali ishemično kap ali pri katerih je bilo ugotovljeno periferno arterijsko obolenje.
When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Kri se strjuje zaradi posebnih celic v krvi, imenovanih trombociti, ki agregirajo (se zlepljajo).
In ST segment elevation myocardial infarction, fewer patients on Clopidogrel BMS had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Pri miokardnem infarktu z elevacijo spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Clopidogrel BMS, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2 121 v primerjavi z 2 310 v študiji COMMIT).
Clopidogrel BMS can be started between seven days and six months after the
Zdravilo Clopidogrel BMS se lahko začne jemati od sedem dni po napadu in do šest mesecev po njem;
Clopidogrel BMS has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Clopidogrel BMS with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Zdravilo Clopidogrel BMS so primerjali tudi s placebom v dveh študijah z bolniki z elevacijo ST spojnice: študija CLARITY je vključevala več kot 3 000 bolnikov in je trajala do osem dni, študija COMMIT pa je vključevala skoraj 46 000 bolnikov, ki so do štiri tedne prejemali zdravilo Clopidogrel BMS z metoprololom (drugim zdravilom za težave s srcem ali visok krvni tlak) ali brez njega.
What benefit has Clopidogrel BMS shown during the studies?
Kakšne koristi je zdravilo Clopidogrel BMS izkazalo med študijami?
For the full list of all side effects reported with Clopidogrel BMS, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Clopidogrel BMS, glejte navodilo za uporabo.
This showed that Clopidogrel BMS reduces the risk of an event.
To je dokaz, da zdravilo Clopidogrel BMS znižuje tveganje za pojav
Clopidogrel BMS is a medicine that contains the active substance clopidogrel.
Clopidogrel BMS je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel BMS's benefits are greater than its risks in adults for the prevention of atherothrombotic events.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Clopidogrel BMS za bolnike, pri katerih obstaja nevarnost aterotrombotičnih dogodkov, večje od z njim povezanih tveganj.
• patients who have had a recent ischaemic stroke (stroke caused by the failure of the blood supply to part of the brain).
• bolnikom, ki so nedavno utrpeli ishemično kap (kap, ki jo povzroči pomanjkljiva oskrba določenega dela možganov s krvjo).
In acute coronary syndrome, Clopidogrel BMS has been compared with placebo (a dummy treatment) in over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Pri akutnem koronarnem sindromu so zdravilo Clopidogrel BMS primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 12 000 bolnikih brez elevacije ST spojnice, od katerih so 2 172 med študijo vstavili stent (študija CURE, trajala do enega leta).
The full EPAR for Clopidogrel BMS is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel BMS je na voljo tukaj.
What is the risk associated with Clopidogrel BMS?
Kakšna tveganja so povezana z zdravilom Clopidogrel BMS?
The active substance in Clopidogrel BMS, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel BMS, klopidogrel, je zaviralec agregacije trombocitov.
Why has Clopidogrel BMS been approved?
Zakaj je bilo zdravilo Clopidogrel BMS odobreno?
How has Clopidogrel BMS been studied?
Kako je bilo zdravilo Clopidogrel BMS raziskano?
How does Clopidogrel BMS work?
Kako zdravilo Clopidogrel BMS deluje?
Clopidogrel BMS can be given to the following groups of patients:
Zdravilo Clopidogrel BMS se lahko daje
o uncontrolled hypertension,
o nenadzorovano hipertenzijo,
A study is also needed to assess the effectiveness of the risk minimisation measures adopted during this review.
Potrebna je tudi študija za oceno učinkovitosti ukrepov za zmanjšanje tveganja, sprejetih med tem pregledom.
Overall summary of the scientific evaluation by the PRAC
Splošni povzetek znanstvenega ocenjevanja v odboru PRAC
Currently, safety follow-up of patients is recommended from initiation of the first treatment course and until 48 months after the last treatment course.
Trenutno se priporoča varnostno spremljanje bolnikov od začetka prvega postopka zdravljenja do 48 mesecev po zadnjem postopku zdravljenja.
Provisional measures were introduced at the start of procedure to protect patients while the detailed evaluation was ongoing.
Na začetku postopka so bili uvedeni začasni ukrepi za zaščito bolnikov v času podrobnega ocenjevanja.
- Fatal cases: Several fatal cases were identified during the PSUSA procedure, which indicate that the current recommendations for monitoring may be insufficient.
- smrtni primeri: v postopku PSUSA je bilo ugotovljenih več smrtnih primerov, kar kaže, da so trenutna priporočila za spremljanje morda nezadostna;
However, in individual cases autoimmune conditions may occur or be diagnosed later so healthcare professionals should be aware of this possibility.
Vendar se v posameznih primerih lahko pojavijo ali pozneje diagnosticirajo avtoimunska stanja, zato morajo zdravstveni delavci to možnost poznati.
PRAC noted that these risks, which are serious and which can in some cases have a fatal outcome, are largely unpredictable.
Odbor PRAC je ugotovil, da so ta tveganja, ki so resna in lahko imajo v nekaterih primerih smrtni izid, večinoma nepredvidljiva;
• PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Lemtrada.
• odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravilo Lemtrada;
Furthermore, when selecting the most appropriate and effective treatment for the patient, the safety profile and the possibility to manage risks effectively should also be taken into consideration.
Poleg tega je treba pri izbiri najustreznejšega in najučinkovitejšega zdravljenja za bolnika upoštevati tudi varnostni profil in možnost učinkovitega obvladovanja tveganj.
This level of efficacy is present across a wide range of patient populations, as evidenced by the consistency of findings across various subgroups of participants in alemtuzumab clinical studies.
Ta raven učinkovitosti je prisotna pri številnih skupinah bolnikov, kar dokazuje skladnost ugotovitev za različne podskupine udeležencev kliničnih študij alemtuzumaba.
o severe active infections until complete resolution,
o hudimi aktivnimi okužbami do popolne ozdravitve,
In such circumstances it is necessary to restrict use of the alemtuzumab to patients who can benefit the most from treatment and who may be ready to accept the serious risks associated with treatment.
V takšnih razmerah je treba uporabo alemtuzumaba omejiti na bolnike, ki jim bo zdravljenja najbolj koristilo in ki so morda pripravljeni sprejeti resna tveganja, povezana z zdravljenjem.
On 10 April 2019 the European Commission (EC) therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data and requested the PRAC to assess the above safety concerns and their impact on the benefit-risk balance of Lemtrada and to issue a recommendation on whether the relevant marketing authorisation should be maintained, varied, suspended or revoked.
Evropska komisija je zato 10. aprila 2019 na podlagi farmakovigilančnih podatkov uvedla postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, naj oceni zgornje varnostne pomisleke in njihov vpliv na razmerje med tveganji in koristmi zdravila Lemtrada ter izda priporočilo o tem, ali naj se ustrezno dovoljenje za promet z zdravilom ohrani, spremeni, začasno umakne ali odvzame.
However it was ultimately considered that this long hospitalisation may not be feasible and that, as highlighted by the SAG, there is limited data to indicate it will have a substantial impact in the management of post-infusion adverse reactions.
Vendar je na koncu menil, da ta dolgotrajna hospitalizacija morda ni izvedljiva in da je, kot poudarja SAG, na voljo le malo podatkov, ki kažejo, da bi pomembno vplivala na obvladovanje neželenih učinkov po infuziji.
PRAC also considered the views expressed by the neurology scientific advisory group.
Upošteval je tudi stališča znanstvene svetovalne skupine za nevrologijo;
The relative young age of patients who died within a short period (30 days) from Lemtrada treatment is also noted.
Zabeležena je tudi relativno nizka starost bolnikov, ki so umrli v kratkem času (30 dni) po zdravljenju z zdravilom Lemtrada.
During the assessment of the periodic safety update report (PSUSA) for Lemtrada (EMEA/H/C/PSUSA/00010055/201809), the following new emerging and serious safety concerns were highlighted in addition to the known safety profile of alemtuzumab, which raised major concerns to the Pharmacovigilance Risk Assessment Committee (PRAC):
Med ocenjevanjem rednega posodobljenega poročila o varnosti zdravila (PSUSA) za zdravilo Lemtrada (EMEA/H/C/PSUSA/00010055/201809) so bili poleg že znanega varnostnega profila alemtuzumaba poudarjeni naslednji novo nastali in resni varnostni pomisleki, kar je pri Odboru za ocenjevanje tveganja na področju farmakovigilance (PRAC) vzbudilo večje pomisleke:
• The PRAC considered that given the serious and unpredictable nature of the risks, and that effective risk minimisation is key to support a positive benefit-risk balance, a drug utilisation study is necessary to assess effectiveness of risk minimisation measures.
• odbor PRAC meni, da je zaradi resnih in nepredvidljivih tveganj ter dejstva, da je učinkovito zmanjševanje tveganja ključnega pomena za podporo pozitivnemu razmerju med koristjo in tveganjem, potrebna študija uporabe zdravila, da se oceni učinkovitost ukrepov za zmanjšanje tveganja;
Considering the serious and unpredictable nature of the newly-identified adverse reactions, it is important to understand whether the newly implemented measures are adhered to in clinical practice.
Glede na resnost in nepredvidljivost na novo ugotovljenih neželenih učinkov je treba ugotoviti, ali se novo uvedeni ukrepi upoštevajo v klinični praksi.
One general characteristic of alemtuzumab which impacts on its safety profile and on risk management is the very long treatment effect, and thereby the infrequent administration regimen.
Splošna značilnost alemtuzumaba, ki vpliva na njegov varnostni profil in obvladovanje tveganja, je zelo dolg učinek zdravljenja in s tem tudi redko dajanje zdravila.
Therefore many of the newly-identified risks associated to Lemtrada are unpredictable and largely unavoidable.
Veliko na novo ugotovljenih tveganj, povezanih z zdravilom Lemtrada, je zato nepredvidljivih in večinoma neizogibnih.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Potem ko je Odbor za zdravila za uporabo v humani medicini (CHMP) pregledal priporočilo odbora PRAC, se je strinjal s končnimi zaključki in podlagami za priporočilo.
The current evidence is insufficient to conclude on a causal relationship with Lemtrada.
Trenutni dokazi ne zadoščajo za sklepanje o vzročni zvezi z zdravilom Lemtrada.
New infusion instructions are also proposed to allow early identification and management of serious adverse reactions temporally associated with infusion.
Predlagana so tudi nova navodila za infuzijo, ki omogočajo zgodnje prepoznavanje in obvladovanje resnih neželenih učinkov, ki so časovno povezani z infuzijo.
During the procedure, other new adverse reactions were identified which are also considered related to Lemtrada such as Epstein-Barr virus re-activation.
Med postopkom so bili ugotovljeni drugi novi neželeni učinki, ki se tudi štejejo za povezane z zdravilom Lemtrada, kot je na primer ponovno aktiviranje virusa Epstein-Barr.
The PRAC considered a recommendation for a longer follow-up period in hospital (for up to 5 days after the last infusion) to allow for prompt identification and management of serious adverse reactions that may occur.
Odbor PRAC je proučil priporočilo za daljše obdobje spremljanja v bolnišnici (do 5 dni po zadnji infuziji), da se omogoči takojšnje prepoznavanje in obvladovanje resnih neželenih učinkov, ki se lahko pojavijo.
These risks are considered to be related to cytokine release syndrome, which has been described in the literature for alemtuzumab1,2.
Šteje se, da so ta tveganja povezana s sindromom sproščanja citokinov, ki je za alemtuzumab opisan v literaturi1,2.
• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or
• bolniki z boleznijo, ki je zelo aktivna kljub celotnemu in ustreznemu poteku zdravljenja z vsaj enim zdravilom, ki spreminja potek bolezen (DMT), ali
The efficacy of alemtuzumab in relapsing remitting multiple sclerosis patients across multiple parameters of the disease is well established and maintained over long term follow up.
Učinkovitost alemtuzumaba pri bolnikih z recidivno-remitentno multiplo sklerozo po več parametrih bolezni je dobro ugotovljena in se ohranja pri dolgoročnem spremljanju.
A matter of concern is the post-marketing reporting rate of fatalities, including those with short latency after alemtuzumab infusion.
Zaskrbljujoče je število smrtnih primerov, o katerih se poroča po pridobitvi dovoljenja za promet z zdravilom, vključno s tistimi s kratko latenco po infuziji alemtuzumaba.
Thus, due to the long term effect of alemtuzumab, treatment discontinuation has limited value from a risk management perspective.
Zaradi dolgoročnega učinka alemtuzumaba je prekinitev zdravljenja z vidika obvladovanja tveganja omejena.
Patients with other concomitant autoimmune diseases (besides MS) should also be contraindicated to minimise the risk of development of additional autoimmune disorders.
Tudi bolnike z drugimi sočasnimi avtoimunskimi boleznimi (poleg multiple skleroze) je treba kontraindicirati, da se zmanjša tveganje za razvoj dodatnih avtoimunskih motenj.
The MAH for Lemtrada will also disseminate a DHPC to inform healthcare professionals of the outcome of this review, and the educational material for both healthcare professionals and patients will be updated.
Imetnik dovoljenja za promet z zdravilom Lemtrada bo razposlal tudi neposredno obvestilo zdravstvenim delavcem, s katerim jih bo obvestil o rezultatih tega pregleda, izobraževalno gradivo za zdravstvene delavce in bolnike pa bo posodobljeno.
Limited information, including lack of detailed information on the individual cases, was available on these concerns during the PSUSA assessment, precluding a thorough evaluation.
Med ocenjevanjem PSUSA so bile za te pomisleke na voljo omejene informacije, vključno s pomanjkanjem podrobnih informacij o posameznih primerih, kar onemogoča temeljito oceno.
This includes not just a restricted therapeutic indication but also contraindications in subpopulations anticipated, due to risk factors, to be at higher risk of developing the serious adverse reactions.
To ne vključuje le omejitve indikacije zdravljenja, temveč tudi kontraindikacije za podskupine bolnikov, za katere se pričakuje, da bodo zaradi dejavnikov tveganja izpostavljeni večjemu tveganju za nastanek resnih neželenih učinkov.
• PRAC also made additional recommendations for monitoring of patients before, during and after infusion to ensure timely diagnosis and management of adverse reactions.
• odbor PRAC je pripravil tudi dodatna priporočila za spremljanje bolnikov pred in med infuzijo ter po njej, da se zagotovi pravočasna diagnoza in obvladovanje neželenih učinkov;
The MAH proposed to include also specialised infusion centres with ready access to intensive care.
Imetnik dovoljenja za promet z zdravilom je predlagal, da se vključijo tudi specializirani infuzijski centri z ustreznim dostopom do intenzivne nege.
As part of the current review, a number of serious, life-threatening and disabling risks associated with Lemtrada have been assessed.
V okviru sedanjega pregleda je bilo ocenjenih več resnih, smrtno nevarnih tveganj in tveganj za prizadetost, povezanih z zdravilom Lemtrada.
• PRAC also considered that the data currently available on mortality incidence is limited and therefore the MAH shall investigate the incidence of mortality in patients treated with Lemtrada compared with a relevant patient population.
• odbor PRAC meni tudi, da so trenutno razpoložljivi podatki o pojavnosti umrljivosti omejeni, zato mora imetnik dovoljenja za promet z zdravilom proučiti pojavnost umrljivosti pri bolnikih, ki se zdravijo z zdravilom Lemtrada, v primerjavi z ustrezno skupino bolnikov.
There are uncertainties about a potential causal relationship with a number of other autoimmune adverse events reported in temporal association with Lemtrada, and these will have to continue to be closely monitored in the future.
Obstajajo negotovosti glede možne vzročne povezave z več drugimi avtoimunskimi neželenimi učinki, o katerih poročajo, da so časovno povezani z zdravilom Lemtrada in jih bo treba še naprej natančno spremljati.
In addition to close monitoring of cardiovascular function before, during and after the infusion, this also includes new recommendations for platelet count measurement during the infusion cycle and for post-infusion monthly liver transaminase testing.
Ta navodila poleg natančnega spremljanja delovanja srca in ožilja pred in med infuzijo ter po njej vključujejo tudi nova priporočila za merjenje števila trombocitov med infuzijskim ciklusom in za mesečno testiranje jetrne transaminaze po infuziji.
Cases of poly-autoimmunity associated with Lemtrada have also been identified.
Ugotovljeni so tudi primeri poliavtoimunosti, povezane z zdravilom Lemtrada.
o history of arterial dissection of the cervicocephalic arteries,
o anamnezo disekcije cervikocefalnih arterij,
As a consequence, PRAC recommended the variation to the terms of the marketing authorisation for Lemtrada.
Posledično je priporočil spremembo pogojev dovoljenja za promet z zdravilom Lemtrada.
In view of the above, PRAC concluded that the benefit-risk balance of Lemtrada remains favourable subject to changes to the product information, the educational materials and additional pharmacovigilance activities described above.
Ob upoštevanju vsega navedenega je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravila Lemtrada ugodno, če se upoštevajo zgoraj navedene spremembe informacij o zdravilu, izobraževalnega gradiva in dejavnosti na področju farmakovigilance.
• Lemtrada should also be contraindicated in patients with:
• zdravilo Lemtrada je treba kontraindicirati pri bolnikih z/s:
In order to ensure adequate monitoring of patients before, during and after the infusion of alemtuzumab, rapid diagnosis and prompt and adequate treatment of the above mentioned risks, the infusion of alemtuzumab should take place in a hospital with availability of experts and adequate
Da bi zagotovili ustrezno spremljanje bolnikov pred in med infuzijo alemtuzumaba ter po njej, hitro diagnozo ter hitro in ustrezno obravnavo navedenih tveganj, je treba infuzijo alemtuzumaba opraviti v