FrancophonIA/ELRC3.0 huggingface dataset:
English: These receptors control blood levels of cholesterol, especially LDLcholesterol, by removing it from the bloodstream.
Slovenian: Receptorji uravnavajo ravni holesterola v krvi, predvsem holesterola LDL, tako da ga odstranijo iz krvnega obtoka.
English: By attaching and blocking PCSK9, Praluent prevents the receptors from being broken down inside cells and therefore increases the number of these receptors on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream.
Slovenian: Zdravilo Praluent z vezavo na encim PCSK9 in njegovim zaviranjem preprečuje razgradnjo receptorjev v celicah, kar poveča njihovo število na celični površini, na kateri se lahko vežejo na holesterol LDL ter ga odstranijo iz krvnega obtoka.
English: It contains the active substance alirocumab.
Slovenian: Vsebuje učinkovino alirokumab.
English: How does Praluent work?
Slovenian: Kako zdravilo Praluent deluje?
English: Alirocumab also helps to reduce other fatty substances from blood in patients with mixed dyslipidaemia.
Slovenian: Zdravilo Praluent pri bolnikih z mešano dislipidemijo prav tako pomaga zniževati druge maščobe v krvi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rapiscan on 6 September 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rapiscan, veljavno po vsej Evropski uniji, izdala 6. septembra 2010.
English: It is used in adult patients (aged 18 years or over) who are unable to exercise enough for a stress test.
Slovenian: Uporablja se pri odraslih bolnikih (starejših od 18 let), ki ne morejo dovolj telovaditi za obremenitveni test.
English: Rapiscan should only be used once within any 24-hour period.
Slovenian: Zdravilo Rapiscan se lahko uporabi samo enkrat v 24-urnem obdobju.
English: What measures are being taken to ensure the safe and effective use of Rapiscan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rapiscan?
English: This is a summary of the European public assessment report (EPAR) for Rapiscan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rapiscan.
English: The full EPAR for Rapiscan can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) je na voljo na spletni strani agencije EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Rapiscan must only be used in a hospital that has equipment for resuscitation and monitoring the patient.
Slovenian: Zdravilo Rapiscan se lahko uporablja samo v bolnišnici, ki ima na voljo opremo za oživljanje in spremljanje bolnika.
English: A risk management plan has been developed to ensure that Rapiscan is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Rapiscan je bil pripravljen načrt obvladovanja tveganj.
English: The CHMP decided that Rapiscan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Rapiscan večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Rapiscan regadenoson
Slovenian: Rapiscan regadenozon
English: The ‘agreement rates' between the first and second scans were similar regardless of which of the two medicines were used for the second scan.
Slovenian: Stopnje ujemanja med prvim in drugim slikanjem so bile podobne, ne glede na to, katero zdravilo je bilo uporabljeno za drugo slikanje.
English: Other information about Rapiscan:
Slovenian: Druge informacije o zdravilu Rapiscan:
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 Rapiscan.
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: The patient then undergoes the procedures for radionuclide myocardial perfusion imaging, starting with an injection of a radioactive substance 10 to 20 seconds after the sodium chloride injection.
Slovenian: Pri bolniku se nato izvede postopek radionuklidnega slikanja miokardne perfuzije, ki se začne z injiciranjem radioaktivne snovi 10 do 20 sekund po injiciranju natrijevega klorida.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rapiscan, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: It is given as a 10-second injection of 400 micrograms into a vein immediately followed by an injection of sodium chloride (salt) solution.
Slovenian: Daje se kot 10-sekundna 400-mikrogramska injekcija v veno, kateri takoj sledi injiciranje raztopine natrijevega klorida (soli).
English: The main measure of effectiveness was based on the similarity between the results of the scans with Rapiscan and adenosine.
Slovenian: Glavno merilo učinkovitosti je temeljilo na podobnosti rezultatov slikanj z zdravilom Rapiscan in adenozinom.
English: The active substance in Rapiscan, regadenoson, is an A2A adenosine receptor agonist.
Slovenian: Zdravilna učinkovina v zdravilu Rapiscan, regadenozon, je agonist receptorja adenozina A2A.
English: What benefit has Rapiscan shown during the studies?
Slovenian: Kakšne koristi je zdravilo Rapiscan izkazalo med študijami?
English: They should also stop receiving dipyridamole (a medicine used to prevent blood clots) for at least two days before receiving Rapiscan.
Slovenian: Prav tako morajo nehati jemati dipiridamol (zdravilo za preprečevanje krvnih strdkov) vsaj dva dni pred prejetjem zdravila Rapiscan.
English: For more information about treatment with Rapiscan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Rapiscan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In two main studies, around 2,000 adult patients first had a myocardial perfusion imaging scan performed using adenosine (another medicine used as a stress agent) followed by a second scan with either adenosine or Rapiscan.
Slovenian: V dveh glavnih študijah je bilo pri okoli 2 000 odraslih bolnikov slikanje miokardne perfuzije najprej opravljeno z adenozinom (drugim zdravilom, ki se uporablja kot sredstvo za obremenitev), drugo slikanje pa je bilo nato izvedeno z adenozinom ali zdravilom Rapiscan.
English: Because Rapiscan causes a rapid increase in heart rate and a fall in blood pressure, patients should remain sitting or lying down and be monitored frequently until the effects of the medicine have worn off.
Slovenian: Ker zdravilo Rapiscan povzroči hitro zvišanje srčnega utripa in znižanje krvnega tlaka, naj bolniki ostanejo v sedečem ali ležečem položaju in pod nadzorom v pogostih časovnih presledkih tako dolgo, dokler učinki zdravila ne izzvenijo.
English: For further information on the use of Rapiscan, see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o uporabi zdravila Rapiscan glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Rapiscan is used as a ‘stress agent' that has a similar effect on the heart as exercise.
Slovenian: Zdravilo Rapiscan se uporablja kot „sredstvo za obremenitev“, ki ima podoben učinek na srce kot telesna vadba.
English: The most common side effects with Rapiscan (seen in more than 1 patient in 10) are headache, dizziness, ST segment changes (an abnormal reading on the electrocardiogram or ECG), flushing (reddening of the skin), dyspnoea (difficulty breathing), gastrointestinal (stomach and gut) discomfort and chest pain.
Slovenian: Najpogostejši neželeni učinki zdravila Rapiscan (opaženi pri več kot 1 bolniku od 10) so glavobol, omotica, spremembe segmentov ST (nenavaden zapis na elektrokardiogramu ali EKG-ju), zardevanje (pordelost kože), dispneja (oteženo dihanje), prebavne motnje in bolečina v prsih.
English: It is used in a type of heart scan called ‘radionuclide myocardial perfusion imaging' to see the blood flow in the heart muscle.
Slovenian: Uporablja se pri vrsti slikanja srca, imenovanega „radionuklidno slikanje miokardne perfuzije“ za opazovanje dotoka krvi v srčno mišico.
English: The results of scans using Rapiscan and adenosine were comparable.
Slovenian: Rezultati slikanj z uporabo zdravila Rapiscan in adenozina so bili primerljivi.
English: Rapiscan must not be used in patients with slow heart rate unless they have a pacemaker, unstable angina (a type of chest pain that changes in severity) that has not been controlled with treatment, severe hypotension (low blood pressure) or decompensated heart failure (when the heart does not work as well as it should).
Slovenian: Ne smejo ga uporabljati bolniki s počasnim utripom srca, razen če imajo nameščen srčni spodbujevalnik, bolniki z nestabilno angino pektoris (vrsto bolečine v prsih, ki se spreminja v jakosti), ki ni uravnana z zdravili, hudo hipotenzijo (nizkim krvnim tlakom) ali dekompenziranim stanjem srčnega popuščanja (kadar srce ne deluje tako, kot bi moralo).
English: What is the risk associated with Rapiscan?
Slovenian: Kakšna tveganja so povezana z zdravilom Rapiscan?
English: Patients must not take any medicines or products that contain methylxanthines (such as caffeine or theophylline) for at least 12 hours before receiving Rapiscan.
Slovenian: Bolniki vsaj 12 ur pred dajanjem zdravila Rapiscan ne smejo uživati nobenih zdravil, ki vsebujejo metilksantine (npr. kofein ali teofilin).
English: It works by attaching to A2A adenosine receptors in the walls of the blood vessels in the heart, causing the blood vessels to widen and increasing blood flow into the heart muscle.
Slovenian: Deluje tako, da se veže na receptorje adenozina A2A v stenah krvnih žil srca, kar povzroči, da se krvne žile razširijo in se poveča dotok krvi v srčno mišico.
English: Why has Rapiscan been approved?
Slovenian: Zakaj je bilo zdravilo Rapiscan odobreno?
English: Rapiscan is for diagnostic use only.
Slovenian: Zdravilo Rapiscan je samo za diagnostično uporabo.
English: Rapiscan is a solution for injection that contains the active substance regadenoson.
Slovenian: Zdravilo Rapiscan je raztopina za injiciranje, ki vsebuje zdravilno učinkovino regadenozon.
English: For the full list of all side effects reported with Rapiscan, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rapiscan, glejte navodilo za uporabo.
English: Before this type of scan, the patient's heart is usually put under stress by exercise such as walking or running on a treadmill to help dilate (widen) the blood vessels in the heart and increase the blood flow to the heart muscle.
Slovenian: Pred izvedbo te vrste slikanja se bolnikovo srce običajno izpostavi obremenitvi s telesno vadbo, kot sta hoja ali tek na tekočem traku, kar pripomore k razširitvi krvnih žil v srcu in povečanju dotoka krvi v srčno mišico.
English: How has Rapiscan been studied?
Slovenian: Kako je bilo zdravilo Rapiscan raziskano?
English: How is Rapiscan used?
Slovenian: Kako se zdravilo Rapiscan uporablja?
English: What is Rapiscan?
Slovenian: Kaj je zdravilo Rapiscan?
English: What is Rapiscan used for?
Slovenian: Za kaj se zdravilo Rapiscan uporablja?
English: This enables the blood flow in the heart to be seen more easily during myocardial perfusion imaging.
Slovenian: Med slikanjem miokardne perfuzije je tako dotok krvi v srce bolje viden.
English: How does Rapiscan work?
Slovenian: Kako zdravilo Rapiscan deluje?
English: (See section 4.4)
Slovenian: (Glejte poglavje 4.4)
English: The duration of protection beyond 4 years is currently under investigation.
Slovenian: Raziskovanje trajanja zaščite po več kot 4 letih trenutno poteka.
English: If not used within 6 hours it should be discarded.
Slovenian: Če ni uporabljeno v 6 urah, ga je treba zavreči.
English: From a microbiological point of view, the vaccine should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba cepivo uporabiti takoj.
English: The clinical relevance of this data is not known.
Slovenian: Klinična pomembnost teh podatkov ni znana.
English: It usually occurs in one part of the body and can last for several weeks.
Slovenian: Po navadi se pojavi na enem delu telesa in lahko traja več tednov.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur na temperaturi 30 °C.
English: • you have a severe infection with a high temperature (fever).
Slovenian: • če imate hudo okužbo z visoko temperaturo (vročino).
English: In these cases, the vaccination may have to be postponed until you have recovered.
Slovenian: V takšnih primerih bo cepljenje morda treba odložiti, dokler ne okrevate.
English: Efficacy has not been assessed for the 0, 6-month schedule.
Slovenian: Učinkovitost ni bila ocenjena za shemo 0 in 6 mesecev.
English: The first injection can be given from the age of 50 years onwards.
Slovenian: Prvo injekcijo je mogoče dati v starosti od 50. leta naprej.
English: Most of these reactions were not long-lasting (median duration of 2 to 3 days).
Slovenian: Večina teh učinkov ni trajala dolgo (mediano od 2 do 3 dni).
English: This medicinal product must not be mixed with other medicinal products.
Slovenian: Zdravila se ne sme mešati z drugimi zdravili.
English: § Not statistically significant
Slovenian: § Ni statistično značilno.
English: For adjuvant see also section 2.
Slovenian: Za adjuvans glejte tudi poglavje 2.
English: • You will receive 2 injections with an interval of 2 months.
Slovenian: • Dobili boste 2 injekciji v presledku 2 mesecev.
English: • Do not use this medicine after the expiry date which is stated on the label and carton.
Slovenian: • Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: Concomitant use with other vaccines is not recommended due to lack of data.
Slovenian: Sočasna uporaba z drugimi cepivi ni priporočljiva, zaradi pomanjkanja podatkov.
English: Make sure you finish the complete vaccination course.
Slovenian: Poskrbite, da boste dokončali celotni ciklus cepljenja.
English: A total of 135 adults, of whom 73
Slovenian: Skupno 135 odraslih, od katerih je bilo
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil morata biti ime in serijska številka uporabljenega zdravila jasno zabeležena.
English: Laboratory confirmation of HZ cases was not part of the study procedures.
Slovenian: Laboratorijska potrditev primerov HZ ni bila del postopkov študije.
English: Maladministration via the subcutaneous route may lead to an increase in transient local reactions.
Slovenian: Nepravilna uporaba subkutano lahko poveča prehodne lokalne reakcije.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first;
Slovenian: Blažja okužba, na primer prehlad, ne bi smela biti težava, vendar se prej posvetujte z zdravnikom,
English: Speak to your doctor for more information.
Slovenian: Za več informacij se posvetujte z zdravnikom.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8°C.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 6 ur pri temperaturi od 2 °C - 8 °C.
English: Powder (gE antigen):
Slovenian: Prašek (antigen gE):
English: Most of these side effects are mild to moderate in intensity and are not long-lasting.
Slovenian: Večina teh neželenih učinkov je blagih do zmernih in niso dolgotrajni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2018
Slovenian: Datum prve odobritve: 21. marec 2018
English: The studies were not designed to demonstrate efficacy in subgroups of frail individuals, including those with multiple comorbidities, although these subjects were not excluded from the studies.
Slovenian: Študiji nista bili zasnovani za prikaz učinkovitosti v podskupinah slabotnih posameznikov, vključno s posamezniki s številnimi pridruženimi boleznimi, čeprav ti posamezniki iz študij niso bili izključeni.
English: Very common headache
Slovenian: Zelo pogosti glavobol
English: This is a higher recurrence rate than generally reported in observational studies in unvaccinated individuals with a history of HZ.
Slovenian: To je višja stopnja ponovitve, kot je na splošno poročano v opazovalnih študijah pri necepljenih posameznikih z zgodovino HZ.
English: Month 38**
Slovenian: 38. mesec**
English: Healthcare professionals therefore need to weigh the benefits and risks of HZ vaccination on an individual basis.
Slovenian: Zdravstveni delavci morajo zato pretehtati koristi in tveganja cepljenja proti HZ za vsakega posameznika posebej.
English: The most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose;
Slovenian: Najpogosteje poročani neželeni učinki so bili bolečina na mestu injiciranja (68,1 % skupno/odmerek,
English: Month 3*
Slovenian: 3. mesec*
English: There were 9 reports of suspected HZ in 6 subjects over a one-year follow up period.
Slovenian: V tej študiji je bilo 9 primerov domnevnega HZ pri 6 posameznikih v 1-letnem obdobju spremljanja.
English: Vaccine efficacy [95% CI]
Slovenian: Učinkovitost cepiva (%) [95 % IZ]
English: The adjuvant (AS01B) is used to improve the body's response to the vaccine.
Slovenian: Adjuvans (AS01B) je uporabljen za izboljšanje telesnega odziva na cepivo.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, or have recently received any other vaccine.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ali če ste pred nedavnim dobili katero koli drugo cepivo.
English: Subcutaneous administration is not recommended.
Slovenian: Subkutana uporaba ni priporočljiva.
English: Number of HZ cases
Slovenian: Število primerov HZ
English: The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease.
Slovenian: Cepivo je namenjeno samo za profilaktično uporabo in ne za zdravljenje že razvite klinične bolezni.
English: • you are allergic (hypersensitive) to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Slovenian: • če ste alergični (preobčutljivi) na učinkovine ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
English: Shake gently until the powder is completely dissolved.
Slovenian: Rahlo pretresite, dokler se prašek povsem ne raztopi.
English: For intramuscular injection only, preferably in the deltoid muscle.
Slovenian: Samo za intramuskularno injiciranje, po možnosti v deltoidno mišico.
English: Fatigue and malaise may occur following administration (see section 4.8).
Slovenian: Po cepljenju se lahko pojavita utrujenost in slabo počutje (glejte poglavje 4.8).
English: As a consequence of the high vaccine efficacy against HZ, a low number of breakthrough cases were accrued, and it was therefore not possible to draw firm conclusions on these study objectives.
Slovenian: Zaradi velike učinkovitosti cepiva proti HZ je bilo zajeto le majhno število prebojnih primerov, zato trdni sklepi o teh raziskovalnih ciljih niso bili mogoči.
English: EU/1/18/1272/002
Slovenian: EU/1/18/1272/001 EU/1/18/1272/002
English: The vaccines should be administered at different injection sites.
Slovenian: Cepivi je treba injicirati na različni mesti.
English: N GMC (mIU/ml) (95% CI)
Slovenian: N GMC (m i.e./ml) (95 % IZ)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden dobite to cepivo.
English: This helps your immune system (the body's natural defences) stay prepared to fight the virus and protect you against shingles and its complications.
Slovenian: To pomaga imunskemu sistemu (naravni obrambi organizma), da ostane pripravljen na boj z virusom in vas tako zaščiti pred pasovcem in njegovimi zapleti.
English: An immunological correlate of protection has not been established; therefore the level of immune response that provides protection against HZ is unknown.
Slovenian: Imunološki korelat zaščite ni ugotovljen, zato raven imunskega odziva, ki zagotavlja zaščito pred HZ,
English: Reactions reported as severe lasted 1 to 2 days.
Slovenian: Hudi neželeni učinki so trajali 1 do 2 dni.
English: Non-clinical data show that AS01B induces a local and transient activation of the innate immune system through specific molecular pathways.
Slovenian: Predklinični podatki kažejo, da AS01B inducira lokalno in prehodno aktivacijo prirojenega imunskega sistema preko specifičnih molekularnih poti.
English: • skin infections, weakness, muscle paralysis and loss of hearing or vision - these are less common.
Slovenian: • okužbe kože, šibkost, ohromelost mišic (paraliza) in izguba sluha ali vida - ti so manj pogosti.
English: The administration of Shingrix to immunocompromised subjects should be based on careful consideration of potential benefits and risks.
Slovenian: Uporaba cepiva Shingrix pri imunokompromitiranih osebah mora temeljiti na skrbni oceni možnih koristi in tveganj.
English: The use of Shingrix should be in accordance with official recommendations.
Slovenian: Uporaba cepiva Shingrix mora biti v skladu z uradnimi priporočili.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website
Slovenian: To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.
English: This protein is not infectious.
Slovenian: Beljakovina ni kužna.
English: Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination.
Slovenian: Cepivo Shingrix ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev 2-3 dni po cepljenju.
English: CI Confidence interval
Slovenian: IZ Interval zaupanja.
English: As with other vaccines, an adequate immune response may not be elicited in these individuals.
Slovenian: Kot pri drugih cepivih, zadosten imunski odziv morda ne bo dosežen pri teh posameznikih.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Slovenian: Zato morate zdravniku ali medicinski sestri povedati, če ste kdaj v preteklosti omedleli, ko ste dobili injekcijo.
English: The primary vaccination schedule consists of two doses of 0.5 ml each: an initial dose followed by a second dose 2 months later.
Slovenian: Osnovna shema cepljenja obsega dva odmerka po 0,5 ml: začetni odmerek, ki mu sledi drugi odmerek čez 2 meseca.
English: • The other ingredients are:
Slovenian: • Druge sestavine cepiva so:
English: you may get pain which can last for months or years and may be severe.
Slovenian: Ko mehurji pasovca izginejo, se lahko pojavijo bolečine, ki lahko trajajo več mesecev ali let in so lahko hude.