FrancophonIA/ELRC3.0 huggingface dataset:
English: • patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Slovenian: • pri bolnikih, ki imajo nestabilno angino pektoris (hudo vrsto bolečine v prsih) ali so imeli srčni napad brez „elevacije ST-spojnice“ (nenormalnega odčitka na elektrokardiogramu ali EKG-ju), ter pri tistih, ki jim je bil v arterijo vstavljen stent (kratka cevka), ki preprečuje, da bi se arterija zamašila;
English: Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface.
Slovenian: Klopidogrel njihovo zlepljanje zavira tako, da snovi, imenovani ADP, prepreči, da bi se vezala na posebne receptorje na njihovi površini.
English: 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/Acetylsalicylic acid Zentiva.
Slovenian: 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.
English: Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
Slovenian: Rezultati treh študij pri bolnikih z nestabilno angino pektoris ali tistih, ki so doživeli srčni napad, so pokazali, da je bila kombinacija klopidogrela in acetilsalicilne kisline, vzetima v obliki ločenih tablet, učinkovitejša pri preprečevanju dogodkov, kot so srčni napadi, kot acetilsalicilna kislina, vzeta samostojno.
English: Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Slovenian: Acetilsalicilna kislina zaustavi zlepljanje trombocitov z zaviranjem encima, imenovanega prostaglandin ciklooksigenaza.
English: Clopidogrel/Acetylsalicylic acid Zentiva is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki, kot je srčni napad, pri odraslih, ki že jemljejo klopidogrel in acetilsalicilno kislino kot ločeni tableti.
English: Clopidogrel/Acetylsalicylic acid Zentiva must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in Clopidogrel/Acetylsalicylic acid Zentiva.
Slovenian: Zdravila Klopidogrel/acetilsalicilna kislina Zentiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) klopidogrel, nesteroidna protivnetna zdravila (kot je acetilsalicilna kislina) ali katero koli drugo sestavino zdravila Klopidogrel/acetilsalicilna kislina Zentiva.
English: The CHMP noted that Clopidogrel/Acetylsalicylic acid Zentiva is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single Clopidogrel/Acetylsalicylic acid Zentiva tablet simplifies treatment for patients as they will need to take fewer tablets.
Slovenian: CHMP je menil, da je zdravilo Klopidogrel/acetilsalicilna kislina Zentiva primerljivo s tabletami s klopidogrelom in acetilsalicilno kislino, ki se jemljejo ločeno, in zaključil, da kombinacija obeh zdravilnih učinkovin v eni tableti zdravila Klopidogrel/acetilsalicilna kislina Zentiva poenostavi zdravljenje bolnikov, saj bodo lahko zaužili manj tablet.
English: Clopidogrel/Acetylsalicylic acid Zentiva is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
Slovenian: Klopidogrel/acetilsalicilna kislina Zentiva je zdravilo, ki vsebuje dve zdravilni učinkovini, klopidogrel in acetilsalicilno kislino (znano tudi kot aspirin).
English: For the full list of all side effects reported with Clopidogrel/Acetylsalicylic acid Zentiva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Klopidogrel/acetilsalicilna kislina Zentiva, glejte navodilo za uporabo.
English: Both active substances in Clopidogrel/Acetylsalicylic acid Zentiva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Slovenian: Obe zdravilni učinkovini zdravila Klopidogrel/acetilsalicilna kislina Zentiva, klopidogrel in acetilsalicilna kislina, sta antitrombocitni zdravili.
English: It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose).
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki imajo hudo okrnjeno delovanje jeter ali ledvic ali katerih zdravstveno stanje vključuje kombinacijo astme, rinitisa (zamašenega nosu in izcedka iz nosu) in nosnih polipov (izrastkov v nosni sluznici).
English: What benefit has Clopidogrel/Acetylsalicylic acid Zentiva shown during the studies?
Slovenian: Kakšne koristi je zdravilo Klopidogrel/acetilsalicilna kislina Zentiva izkazalo med študijami?
English: Other information about Clopidogrel/Acetylsalicylic acid Zentiva:
Slovenian: Druge informacije o zdravilu Klopidogrel/acetilsalicilna kislina Zentiva:
English: Clopidogrel/Acetylsalicylic acid Zentiva is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se jemlje kot ena tableta enkrat na dan namesto tablete klopidogrela in tablete acetilsalicilne kisline, ki ju je bolnik pred tem jemal ločeno.
English: Clopidogrel/Acetylsalicylic acid Zentiva was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se je izkazalo za primerljivo s klopidogrelom in acetilsalicilno kislino, vzetima ločeno, zato se lahko uporablja namesto tablet s klopidogrelom in acetilsalicilno kislino, ki so jih bolniki jemali dotlej.
English: What is the risk associated with Clopidogrel/Acetylsalicylic acid Zentiva?
Slovenian: Kakšna tveganja so povezana z zdravilom Klopidogrel/acetilsalicilna kislina Zentiva?
English: Why has Clopidogrel/Acetylsalicylic acid Zentiva been approved?
Slovenian: Zakaj je bilo zdravilo Klopidogrel/acetilsalicilna kislina Zentiva odobreno?
English: Clopidogrel/Acetylsalicylic acid Zentiva clopidogrel / acetylsalicylic acid
Slovenian: klopidogrel/acetilsalicilna kislina
English: What is Clopidogrel/Acetylsalicylic acid Zentiva?
Slovenian: Kaj je zdravilo Klopidogrel/acetilsalicilna kislina Zentiva?
English: What is Clopidogrel/Acetylsalicylic acid Zentiva used for?
Slovenian: Za kaj se zdravilo Klopidogrel/acetilsalicilna kislina Zentiva uporablja?
English: How is Clopidogrel/Acetylsalicylic acid Zentiva used?
Slovenian: Kako se zdravilo Klopidogrel/acetilsalicilna kislina Zentiva uporablja?
English: How does Clopidogrel/Acetylsalicylic acid Zentiva work?
Slovenian: Kako zdravilo Klopidogrel/acetilsalicilna kislina Zentiva deluje?
English: How has Clopidogrel/Acetylsalicylic acid Zentiva been studied?
Slovenian: Kako je bilo zdravilo Klopidogrel/acetilsalicilna kislina Zentiva raziskano?
English: The best dose to use in these patients has not yet been determined.
Slovenian: Najprimernejši odmerek za te bolnike še ni bil določen.
English: The full EPAR for Clopidogrel Zentiva can be found on the Agency's: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel Zentiva je na voljo na spletni strani agencije: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This authorisation was based on the authorisation granted to Plavix in 1998 (‘informed consent').
Slovenian: Podlaga za odobritev dovoljenja je bila odobritev za zdravilo Plavix iz leta 1998 („privolitev po pojasnilu“).
English: The name of the medicine was changed to Clopidogrel Zentiva on 23 August 2011.
Slovenian: Ime zdravila je bilo 23. avgusta 2011 spremenjeno v Clopidogrel Zentiva.
English: For genetic reasons, some patients may not be able to convert Clopidogrel Zentiva as effectively as others, which could reduce their response to the medicine.
Slovenian: Zaradi genetskih razlogov ga nekateri bolniki morda presnavljajo manj učinkovito kot drugi, zaradi česar bi se lahko slabše odzvali na zdravilo.
English: There was also a reduction in the patients who had a stent inserted.
Slovenian: Tveganje se je zmanjšalo tudi pri bolnikih, ki so imeli vstavljen stent.
English: Clopidogrel Zentiva clopidogrel
Slovenian: Clopidogrel Zentiva klopidogrel
English: For more information about treatment with Clopidogrel Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Clopidogrel Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: • recently had a myocardial infarction (heart attack).
Slovenian: • ki so nedavno doživeli miokardni infarkt (srčni napad).
English: • peripheral arterial disease (problems with blood flow in the arteries);
Slovenian: • ki imajo periferno arterijsko bolezen (težave s pretokom krvi v arterijah);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Winthrop on 16 July 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Zentiva , veljavno po vsej Evropski uniji, odobrila dne 16. julija 2008.
English: This showed that Clopidogrel Zentiva reduces the risk of an event.
Slovenian: To je dokaz, da zdravilo Clopidogrel Zentiva zmanjšuje tveganje za pojav dogodka.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Zentiva.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel Zentiva.
English: The standard dose of Clopidogrel Zentiva is one 75-mg tablet once a day.
Slovenian: Običajni odmerek zdravila Clopidogrel Zentiva je ena 75-miligramska tableta enkrat dnevno.
English: Clopidogrel Zentiva should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.
Slovenian: Zdravila Clopidogrel Zentiva ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila.
English: In CAPRIE, there were 939 events in the Clopidogrel Zentiva group, and 1,020 in the aspirin group.
Slovenian: V študiji CAPRIE je bilo v skupini, ki je prejemala zdravilo Clopidogrel Zentiva, 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1 020.
English: Clopidogrel Zentiva can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Clopidogrel Zentiva se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
English: Clopidogrel Zentiva is converted into its active form in the body.
Slovenian: Zdravilo Clopidogrel Zentiva se v svojo aktivno obliko pretvori v telesu.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Zentiva is used together with aspirin, the dose of which should not be higher than 100 mg.
Slovenian: Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Clopidogrel Zentiva uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
English: Some of these patients have had a stent inserted (a short tube) placed in an artery to prevent it from closing up.
Slovenian: Nekaterim bolnikom je bil v arterijo vstavljen stent (kratka cevka), da prepreči njeno zamašitev.
English: In acute coronary syndrome, treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets.
Slovenian: Pri akutnem koronarnem sindromu se zdravljenje na splošno začne z udarnim odmerkom ene 300miligramske tablete ali štirih 75-miligramskih tablet.
English: The most common side effects with Clopidogrel Zentiva (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 Zentiva (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, kjer je koža predrta.
English: 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 Zentiva.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel Zentiva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Clopidogrel Zentiva was more effective than aspirin at preventing new ischaemic events.
Slovenian: Zdravilo Clopidogrel Zentiva je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
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 utrpelo nov „ishemični dogodek“ (srčni napad, ishemično kap ali smrt).
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 who experienced an ‘event' such as a blocked artery, another heart attack or death during the study.
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, ponovni srčni napad ali smrt med študijo.
English: Clopidogrel Zentiva can be started between seven days and six months after the stroke;
Slovenian: Zdravilo Clopidogrel Zentiva se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: The CHMP decided that Clopidogrel Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Clopidogrel Zentiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Clopidogrel Zentiva is used to prevent problems caused by blood clots in adults who have:
Slovenian: Zdravilo Clopidogrel Zentiva se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki pri odraslih,
English: Clopidogrel Zentiva is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel Zentiva je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: In the study in atrial fibrillation patients, Clopidogrel Zentiva taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
Slovenian: V študiji atrijske fibrilacije so bolniki zdravilo Clopidogrel Zentiva jemali skupaj z aspirinom, kar je zmanjšalo tveganje za nove dogodke za 11 % v primerjavi s placebom, vzetim skupaj z aspirinom, kjer je bilo največje zmanjšanje, opaženo pri kapi (28 %).
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Slovenian: • ki trpijo za atrijsko fibrilacijo (nerednim hitrim krčenjem zgornjih srčnih preddvorov), pri katerih se mora dajati skupaj z aspirinom.
English: What benefit has Clopidogrel Zentiva shown during the studies?
Slovenian: Kakšne koristi je zdravilo Clopidogrel Zentiva izkazalo med študijami?
English: For the full list of all side effects reported with Clopidogrel Zentiva, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Clopidogrel Zentiva, glejte navodilo za uporabo.
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Slovenian: • ki so nedavno utrpeli ishemično kap (kap zaradi neoskrbe določenega dela možganov s krvjo).
English: Previously known as Clopidogrel Winthrop 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.
Slovenian: pri katerih obstaja vsaj en dejavnik tveganja za vaskularni dogodek, kot je srčni napad ali kap, ki ne morejo jemati antagonistov vitamina K (drugega zdravila, ki preprečuje krvne strdke) in pri katerih obstaja majhno tveganje za krvavitve.
English: Clopidogrel Zentiva has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or ischaemic stroke, or who had established peripheral arterial disease.
Slovenian: Zdravilo Clopidogrel Zentiva 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: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Slovenian: • ki imajo akutni koronarni sindrom, pri katerem se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov).
English: In ST segment elevation myocardial infarction, fewer patients on Clopidogrel Zentiva 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 dvigom spojnice ST je dogodke utrpelo manj bolnikov, ki so jemali zdravilo Clopidogrel Zentiva, od tistih, ki so jemali placebo (262 oziroma 377 v študiji CLARITY in 2 121 oziroma 2 310 v študiji COMMIT).
English: Clopidogrel Zentiva 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 Zentiva with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Slovenian: Zdravilo Clopidogrel Zentiva 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 Zentiva z metoprololom (drugim zdravilom za težave s srcem ali visok krvni tlak) ali brez njega.
English: The active substance in Clopidogrel Zentiva, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel Zentiva, klopidogrel, je zaviralec agregacije trombocitov.
English: In acute coronary syndrome, Clopidogrel Zentiva has been compared with placebo (a dummy treatment) in one study involving 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 Zentiva primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni študiji z 12 000 bolniki brez dviga spojnice ST, od katerih so 2 172 bolnikom med študijo vstavili stent (študija CURE, ki je trajala do enega leta).
English: What is the risk associated with Clopidogrel Zentiva?
Slovenian: Kakšna tveganja so povezana z zdravilom Clopidogrel Zentiva?
English: Why has Clopidogrel Zentiva been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel Zentiva odobreno?
English: Other information about Clopidogrel Zentiva
Slovenian: Druge informacije o zdravilu Clopidogrel Zentiva:
English: In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel Zentiva instead of aspirin.
Slovenian: To pomeni, da bo med bolniki, ki jemljejo zdravilo Clopidogrel Zentiva, manj novih ishemičnih napadov kot pri tistih, ki jemljejo aspirin, saj jemanje zdravila Clopidogrel Zentiva namesto aspirina prepreči ponovni ishemični napad v dveh letih po začetku jemanja pri približno 10 bolnikih od 1 000.
English: In atrial fibrillation, Clopidogrel Zentiva has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Slovenian: Pri atrijski fibrilaciji je bilo zdravilo Clopidogrel Zentiva primerjano s placebom (oba vzeta skupaj z aspirinom) v eni glavni študiji, v kateri je sodelovalo okoli 7 500 bolnikov, ki so imeli vsaj en dejavnik tveganja za vaskularni dogodek in ki ne morejo prejemati zdravljenja z antagonistom vitamina K. Bolniki so bili zdravljeni povprečno tri leta, glavno merilo učinkovitosti pa je bilo število bolnikov, ki so doživeli bodisi srčni napad bodisi ishemično kap ali pa so umrli.
English: How has Clopidogrel Zentiva been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel Zentiva raziskano?
English: What is Clopidogrel Zentiva?
Slovenian: Kaj je zdravilo Clopidogrel Zentiva?
English: What is Clopidogrel Zentiva used for?
Slovenian: Za kaj se zdravilo Clopidogrel Zentiva uporablja?
English: How is Clopidogrel Zentiva used?
Slovenian: Kako se zdravilo Clopidogrel Zentiva uporablja?
English: How does Clopidogrel Zentiva work?
Slovenian: Kako zdravilo Clopidogrel Zentiva deluje?
English: 6 (6 x 1) pre-filled pens + 6 (6 x 1) swab (multipack)
Slovenian: 6(6x1) napolnjenih injekcijskih peresnikov + 6(6x1) blazinic (skupno pakiranje)
English: • Be careful how much alcohol you drink.
Slovenian: • Bodite pozorni na to, koliko alkohola popijete.
English: If this happens, a more specific test can be performed.
Slovenian: Če se to zgodi, se morajo uporabiti bolj specifične preiskave.
English: The mechanism for this increased risk is not known.
Slovenian: Mehanizem tega povečanega tveganja ni znan.
English: The patients in these trials died from a variety of causes that were consistent with expectations for this population.
Slovenian: Bolniki v teh preskušanjih so umrli zaradi različnih vzrokov, ki so se skladali s pričakovanji za to populacijo.
English: Long-term implications for cognitive and behavioural development are not known.
Slovenian: Dolgoročne posledice za kognitivni in vedenjski razvoj niso znane.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu se lahko nato posodobijo s strani pristojnih organov držav članic v sodelovanju z referenčno državo članico, kot je to primerno, skladno s postopki, določenimi v Poglavju 4 Naslova III Direktive 2001/83/EC.
English: Tell your doctor as soon as possible if you have:
Slovenian: Svojemu zdravniku morate čim prej povedati, če imate:
English: The relevance of this finding for humans is unknown.
Slovenian: Pomen te ugotovitve za človeka ni znan.