FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP recommended deletion of the indications related to ‘bovine mastitis caused by Mycoplasma spp.'
Slovenian: Odbor CVMP je priporočil, da se iz informacij o zdravilu za zadevna zdravila izbrišejo indikacije, povezane z „govejim mastitisom, ki ga povzroča bakterija Mycoplasma spp.“ ali „govejim mastitisom, ki ga povzroča bakterija Mycoplasma bovis“.
English: MA (EU) number
Slovenian: Št. (EU) dovoljenja za promet
English: Ref.: EMEA/632126/2009 EMEA/H/C/974
Slovenian: : EMEA/632126/2009 EMEA/H/C/974
English: The best dose to use in these patients has not yet been determined.
Slovenian: Najboljši odmerek za te bolnike še ni bil določen.
English: This corresponds to a relative reduction in risk of 9% compared with aspirin.
Slovenian: To ustreza relativnemu zmanjšanju tveganja za 9 % v primerjavi z aspirinom.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Slovenian: Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel BMS to Bristol Myers Squibb Pharma EEIG on 16 July 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel BMS, veljavno po vsej Evropski uniji, odobrila družbi Bristol Myers Squibb Pharma EEIG dne 16. julija 2008.
English: There was also a reduction in the patients who had a stent inserted.
Slovenian: Do zmanjšanja je prišlo tudi pri bolnikih, ki so imeli vstavljen stent.
English: This authorisation was based on the authorisation granted to Iscover in 1998 (‘informed consent').
Slovenian: Podlaga za odobritev dovoljenja je bila odobritev za zdravilo Iscover iz leta 1998 („privolitev po pojasnilu“).
English: It is available as pink tablets (round: 75 mg; oblong: 300 mg).
Slovenian: Na voljo je v obliki rožnatih tablet (okroglih: 75 mg; podolgovatih: 300 mg).
English: Clopidogrel BMS clopidogrel
Slovenian: Clopidogrel BMS klopidogrel
English: It must not be used in patients who have severe liver disease or a disease that may cause bleeding.
Slovenian: Ne sme se uporabljati pri bolnikih, ki imajo hudo obolenje jeter ali obolenje, ki lahko povzroči krvavitev.
English: For genetic reasons, some patients may not be able to convert Clopidogrel BMS as effectively as others, which could reduce their response to the medicine.
Slovenian: Zaradi genetskih razlogov ga morda nekateri bolniki lahko pretvarjajo manj učinkovito kot drugi, zaradi česar je njihov odziv na zdravilo manjši.
English: In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting
Slovenian: To pomeni, da se bo približno 10 bolnikov od 1 000 izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila
English: • patients who have recently had a myocardial infarction (heart attack).
Slovenian: • bolnikom, ki so nedavno doživeli miokardni infarkt (srčni napad).
English: This means that fewer patients will have new ischaemic events if they receive Clopidogrel BMS than if they receive aspirin.
Slovenian: To pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo jemali zdravilo Clopidogrel BMS, kot pa če bodo jemali aspirin.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Slovenian: • bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah);
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Slovenian: To preprečuje, da bi trombociti postali lepljivi, zmanjšuje tveganje za nastanek krvnih strdkov ter prispeva k preprečevanju novega srčnega napada ali kapi.
English: The standard dose of Clopidogrel BMS is one 75-mg tablet once a day, taken with or without food.
Slovenian: Običajni odmerek zdravila Clopidogrel BMS je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
English: The main measure of effectiveness was how many patients experienced a new ‘ischaemic event' (heart attack, ischaemic stroke or death) over one to three years.
Slovenian: Glavno merilo učinkovitosti je bilo, koliko bolnikov je v enem do treh let imelo nov „ishemični dogodek“ (srčni napad, ishemično kap ali smrt).
English: In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Slovenian: Pri akutnem koronarnem sindromu brez elevacije ST spojnice je znašalo celotno relativno zmanjšanje tveganja za pojav dogodka v primerjavi s placebom 20 %.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Slovenian: Temu sledi običajni 75-miligramski odmerek enkrat na dan v trajanju najmanj štirih tednov (pri miokardnem infarktu z elevacijo ST spojnice) ali največ 12 mesecev (pri sindromu brez elevacije ST spojnice).
English: In acute coronary syndrome, Clopidogrel BMS is used together with aspirin and treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets.
Slovenian: Pri akutnem koronarnem sindromu se zdravilo Clopidogrel BMS uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom ene 300-miligramske tablete ali štirih 75-miligramskih tablet.
English: 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
Slovenian: 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.
English: Clopidogrel BMS is converted into its active form in the body.
Slovenian: Zdravilo Clopidogrel BMS se v svojo aktivno obliko pretvori v telesu.
English: Clopidogrel BMS can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Clopidogrel BMS se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
English: Clopidogrel BMS is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel BMS se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: 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.
Slovenian: 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.
English: In CAPRIE, there were 939 events in the Clopidogrel BMS group, and 1,020 in the aspirin group.
Slovenian: V študiji CAPRIE je bilo v skupini, ki je prejemala zdravilo Clopidogrel, 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1 020.
English: Clopidogrel BMS should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.
Slovenian: Zdravila Clopidogrel BMS ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila.
English: 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.
Slovenian: 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.
English: The Committee recommended that Clopidogrel BMS be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Clopidogrel BMS odobri dovoljenje za promet.
English: Clopidogrel BMS was more effective than aspirin at preventing new ischaemic events.
Slovenian: Zdravilo Clopidogrel BMS je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
English: 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.
Slovenian: 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
English: • 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).
Slovenian: • 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).
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Slovenian: Klopidogrel ustavi zlepljanje trombocitov tako, da spojini, imenovani ADP, preprečuje vezavo na posebne receptorje na njihovi površini.
English: Other information about Clopidogrel BMS:
Slovenian: Druge informacije o zdravilu Clopidogrel BMS:
English: 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.
Slovenian: 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.
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Slovenian: Kri se strjuje zaradi posebnih celic v krvi, imenovanih trombociti, ki agregirajo (se zlepljajo).
English: 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).
Slovenian: 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).
English: Clopidogrel BMS can be started between seven days and six months after the
Slovenian: Zdravilo Clopidogrel BMS se lahko začne jemati od sedem dni po napadu in do šest mesecev po njem;
English: 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.
Slovenian: 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.
English: What benefit has Clopidogrel BMS shown during the studies?
Slovenian: Kakšne koristi je zdravilo Clopidogrel BMS izkazalo med študijami?
English: For the full list of all side effects reported with Clopidogrel BMS, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Clopidogrel BMS, glejte navodilo za uporabo.
English: This showed that Clopidogrel BMS reduces the risk of an event.
Slovenian: To je dokaz, da zdravilo Clopidogrel BMS znižuje tveganje za pojav
English: Clopidogrel BMS is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel BMS je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: 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.
Slovenian: 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.
English: • patients who have had a recent ischaemic stroke (stroke caused by the failure of the blood supply to part of the brain).
Slovenian: • bolnikom, ki so nedavno utrpeli ishemično kap (kap, ki jo povzroči pomanjkljiva oskrba določenega dela možganov s krvjo).
English: 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).
Slovenian: 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).
English: The full EPAR for Clopidogrel BMS is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel BMS je na voljo tukaj.
English: What is the risk associated with Clopidogrel BMS?
Slovenian: Kakšna tveganja so povezana z zdravilom Clopidogrel BMS?
English: The active substance in Clopidogrel BMS, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel BMS, klopidogrel, je zaviralec agregacije trombocitov.
English: Why has Clopidogrel BMS been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel BMS odobreno?
English: How has Clopidogrel BMS been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel BMS raziskano?
English: How does Clopidogrel BMS work?
Slovenian: Kako zdravilo Clopidogrel BMS deluje?
English: Clopidogrel BMS can be given to the following groups of patients:
Slovenian: Zdravilo Clopidogrel BMS se lahko daje
English: o uncontrolled hypertension,
Slovenian: o nenadzorovano hipertenzijo,
English: A study is also needed to assess the effectiveness of the risk minimisation measures adopted during this review.
Slovenian: Potrebna je tudi študija za oceno učinkovitosti ukrepov za zmanjšanje tveganja, sprejetih med tem pregledom.
English: Overall summary of the scientific evaluation by the PRAC
Slovenian: Splošni povzetek znanstvenega ocenjevanja v odboru PRAC
English: Currently, safety follow-up of patients is recommended from initiation of the first treatment course and until 48 months after the last treatment course.
Slovenian: Trenutno se priporoča varnostno spremljanje bolnikov od začetka prvega postopka zdravljenja do 48 mesecev po zadnjem postopku zdravljenja.
English: Provisional measures were introduced at the start of procedure to protect patients while the detailed evaluation was ongoing.
Slovenian: Na začetku postopka so bili uvedeni začasni ukrepi za zaščito bolnikov v času podrobnega ocenjevanja.
English: - Fatal cases: Several fatal cases were identified during the PSUSA procedure, which indicate that the current recommendations for monitoring may be insufficient.
Slovenian: - smrtni primeri: v postopku PSUSA je bilo ugotovljenih več smrtnih primerov, kar kaže, da so trenutna priporočila za spremljanje morda nezadostna;
English: However, in individual cases autoimmune conditions may occur or be diagnosed later so healthcare professionals should be aware of this possibility.
Slovenian: Vendar se v posameznih primerih lahko pojavijo ali pozneje diagnosticirajo avtoimunska stanja, zato morajo zdravstveni delavci to možnost poznati.
English: PRAC noted that these risks, which are serious and which can in some cases have a fatal outcome, are largely unpredictable.
Slovenian: Odbor PRAC je ugotovil, da so ta tveganja, ki so resna in lahko imajo v nekaterih primerih smrtni izid, večinoma nepredvidljiva;
English: • PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Lemtrada.
Slovenian: • odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravilo Lemtrada;
English: 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.
Slovenian: Poleg tega je treba pri izbiri najustreznejšega in najučinkovitejšega zdravljenja za bolnika upoštevati tudi varnostni profil in možnost učinkovitega obvladovanja tveganj.
English: 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.
Slovenian: Ta raven učinkovitosti je prisotna pri številnih skupinah bolnikov, kar dokazuje skladnost ugotovitev za različne podskupine udeležencev kliničnih študij alemtuzumaba.
English: o severe active infections until complete resolution,
Slovenian: o hudimi aktivnimi okužbami do popolne ozdravitve,
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: PRAC also considered the views expressed by the neurology scientific advisory group.
Slovenian: Upošteval je tudi stališča znanstvene svetovalne skupine za nevrologijo;
English: The relative young age of patients who died within a short period (30 days) from Lemtrada treatment is also noted.
Slovenian: Zabeležena je tudi relativno nizka starost bolnikov, ki so umrli v kratkem času (30 dni) po zdravljenju z zdravilom Lemtrada.
English: 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):
Slovenian: 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:
English: • 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.
Slovenian: • 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;
English: 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.
Slovenian: Glede na resnost in nepredvidljivost na novo ugotovljenih neželenih učinkov je treba ugotoviti, ali se novo uvedeni ukrepi upoštevajo v klinični praksi.
English: 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.
Slovenian: Splošna značilnost alemtuzumaba, ki vpliva na njegov varnostni profil in obvladovanje tveganja, je zelo dolg učinek zdravljenja in s tem tudi redko dajanje zdravila.
English: Therefore many of the newly-identified risks associated to Lemtrada are unpredictable and largely unavoidable.
Slovenian: Veliko na novo ugotovljenih tveganj, povezanih z zdravilom Lemtrada, je zato nepredvidljivih in večinoma neizogibnih.
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Slovenian: 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.
English: The current evidence is insufficient to conclude on a causal relationship with Lemtrada.
Slovenian: Trenutni dokazi ne zadoščajo za sklepanje o vzročni zvezi z zdravilom Lemtrada.
English: Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells.
Slovenian: 1 Wing MG et al. Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells.
English: New infusion instructions are also proposed to allow early identification and management of serious adverse reactions temporally associated with infusion.
Slovenian: Predlagana so tudi nova navodila za infuzijo, ki omogočajo zgodnje prepoznavanje in obvladovanje resnih neželenih učinkov, ki so časovno povezani z infuzijo.
English: During the procedure, other new adverse reactions were identified which are also considered related to Lemtrada such as Epstein-Barr virus re-activation.
Slovenian: 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.