natgillin/translations-raw huggingface dataset:
What are the risks associated with Praluent?
Kakšna tveganja so povezana z zdravilom Praluent?
What benefits of Praluent have been shown in studies?
Kakšne koristi je zdravilo Praluent izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Praluent have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Praluent upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Praluent is available as a solution for injection in a pre-filled syringe or pre-filled pen (75 and 150 mg).
Zdravilo Praluent je na voljo kot raztopina za injiciranje v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku (75 in 150 mg).
Side effects reported with Praluent are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Praluent, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Praluent can also be used without a statin in patients who cannot take statins.
Zdravilo Praluent se lahko uporablja tudi brez statina pri bolnikih, ki ga ne morejo jemati.
The most common side effects with Praluent (which may affect up to1 in 10 people) are injection site reactions such as pain and redness, problems affecting the nose and throat such as colds, and itching.
Najpogostejši neželeni učinki zdravila Praluent (ki lahko prizadenejo največ 1 osebo od 10) so reakcije na mestu injiciranja, kot sta bolečina in pordelost, težave, ki prizadenejo nos in grlo, kot so prehladi, in srbenje.
Praluent has been studied in 10 main studies involving over 5,000 adult patients with hypercholesterolaemia (including patients with heterozygous familial disease) and mixed dyslipidaemia.
Zdravilo Praluent so proučevali v desetih glavnih študijah, v katerih je sodelovalo več kot 5 000 odraslih bolnikov s hiperholesterolemijo (vključno z bolniki s heterozigotno družinsko boleznijo) in mešano dislipidemijo.
In a study involving over 18,000 patients who had established heart disease, less than 10% of patients given Praluent had a cardiovascular event (meaning death, heart attack, stroke, chest pain due to problems with the blood flow to the heart leading to hospitalisation) during the study compared with over 11% of patients given placebo.
V študiji, v kateri je sodelovalo več kot 18 000 bolnikov s potrjenim srčnim obolenjem, je manj kot 10 % bolnikov, ki so prejemali zdravilo Praluent, imelo srčno-žilni dogodek (tj. smrt, srčni napad, možgansko kap, bolečine v prsnem košu zaradi težav s krvnim pretokom v srce, ki je privedlo do hospitalizacije), v primerjavi z več kot 11 % bolnikov, ki so prejemali placebo.
In patients with atherosclerotic heart disease, Praluent reduced the number of cardiovascular events, in particular heart attacks and strokes.
Pri bolnikih z aterosklerotičnim srčnim obolenjem je zdravilo Praluent zmanjšalo število srčno-žilnih dogodkov, zlasti srčnih napadov in možganskih kapi.
Before starting treatment with Praluent, other causes of excess cholesterol and abnormal fat levels in the blood should be excluded.
Pred začetkom zdravljenja z zdravilom Praluent je treba izključiti druge vzroke čezmerne ravni holesterola in nenormalnih ravni maščob v krvi.
Praluent is used in combination with a statin or a statin and other fat-lowering medicines.
Zdravilo Praluent se uporablja v kombinaciji s statinom ali statinom in drugimi zdravili za zniževanje ravni maščob.
The active substance in Praluent, alirocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific enzyme called PCSK9.
Učinkovina v zdravilu Praluent, alirokumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna encim, imenovan „PCSK9“, in se veže nanj.
It is also used to reduce the risk of heart problems and strokes in patients who have atherosclerotic cardiovascular disease (heart problems such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries).
Uporablja se tudi za zmanjševanje tveganja za težave s srcem in možganske kapi pri bolnikih, ki imajo aterosklerotično srčno-žilno bolezen (težave s srcem, kot so srčni infarkt, možganska kap ali druge težave obtočil, ki jih povzročajo maščobne obloge v stenah arterij).
Praluent is a medicine for lowering levels of fat in the blood.
Praluent je zdravilo za zniževanje ravni maščob v krvi.
Therefore, Praluent has been approved for use in patients who do not adequately respond to the maximum tolerated dose of statins or who cannot be given statins.
Zdravilo Praluent je bilo zato odobreno za uporabo pri bolnikih, ki se nezadostno odzovejo na največji odmerek statinov, ki ga še lahko prenašajo, in tistih, ki statinov ne smejo prejemati.
Atherosclerotic heart disease
Aterosklerotično srčno obolenje
It is used to reduce fat levels in adults with primary hypercholesterolaemia (high levels of blood cholesterol without an identifiable cause, often resulting from the person's genetic makeup) and mixed dyslipidaemia (abnormal levels of different fats in the blood, including cholesterol).
Uporablja se za zmanjšanje ravni maščobe pri odraslih s primarno hiperholesterolemijo (visokimi ravnmi holesterola v krvi brez določljivega vzroka, ki so pogosto posledica bolnikove genetske zasnove) in mešano dislipidemijo (nenormalnimi ravnmi različnih maščob v krvi, vključno s holesterolom).
The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, treatment with Praluent led to a significant reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular (affecting the heart and blood vessels) disease.
Agencija je ugotovila, da so v vseh študijah z zdravilom Praluent pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo, vključno pri bolnikih, ki so uporabljali največji priporočeni odmerek statinov, in bolnikih, ki statinov niso prenašali, dokazali pomembno znižanje ravni holesterola LDL, ki je znani dejavnik tveganja za srčno-žilne bolezni (bolezni, ki prizadenejo srce in krvne žile).
How is Praluent used?
Kako se zdravilo Praluent uporablja?
This helps to reduce the amount of LDL-cholesterol in the blood.
S tem pripomorejo k zniževanju ravni holesterola LDL v krvi.
The dose of Praluent is adjusted based on the levels of fats in blood and response to the medicine.
Odmerek zdravila Praluent je treba prilagajati glede na ravni maščob v krvi in odziv na zdravilo.
Some studies looked at Praluent taken on its own, while others studied Praluent in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins.
V nekaterih študijah so zdravilo Praluent proučevali kot samostojno zdravilo, v drugih pa v kombinaciji z drugimi zdravili za zniževanje ravni maščob, tudi pri bolnikih, ki so uporabljali največje priporočene odmerke statinov.
Some studies compared Praluent with placebo (a dummy treatment) and others to another medicine for hypercholesterolaemia (ezetimibe).
V nekaterih študijah so zdravilo Praluent primerjali s placebom (zdravilom brez učinkovine), v drugih pa z drugim zdravilom za hiperholesterolemijo (ezetimibom).
The injection is given under the skin of the abdomen, thigh or upper arm.
Injekcija se vbrizga pod kožo na trebuhu, stegnu ali nadlahti.
This enzyme attaches to cholesterol receptors on the surface of liver cells and causes these receptors to be absorbed and broken down inside the cells.
Ta encim se na površini jetrnih celic veže na receptorje holesterola, zaradi česar se receptorji v celicah absorbirajo in razgradijo.
When given on top of standard treatment or on its own, Praluent produced a 24 to 36% greater reduction in blood levels of LDL-cholesterol than ezetimibe.
Ko so zdravilo Praluent dajali skupaj s standardnim zdravljenjem ali s placebom, so zabeležili za od 24 do 36 % večje znižanje ravni holesterola LDL v krvi kot pri ezetimibu.
These studies showed that when Praluent was given on top of a statin it led to a substantial reduction in blood levels of LDL-cholesterol (between 39 and 62% more than placebo) after 6 months of treatment.
Študije so pokazale, da je zdravilo Praluent, ki so ga dajali v kombinaciji s statinom, po šestih mesecih zdravljenja znatno znižalo ravni holesterola LDL v krvi (za od 39 do 62 % bolj kot placebo).
These receptors control blood levels of cholesterol, especially LDLcholesterol, by removing it from the bloodstream.
Receptorji uravnavajo ravni holesterola v krvi, predvsem holesterola LDL, tako da ga odstranijo iz krvnega obtoka.
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.
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.
It contains the active substance alirocumab.
Vsebuje učinkovino alirokumab.
How does Praluent work?
Kako zdravilo Praluent deluje?
Alirocumab also helps to reduce other fatty substances from blood in patients with mixed dyslipidaemia.
Zdravilo Praluent pri bolnikih z mešano dislipidemijo prav tako pomaga zniževati druge maščobe v krvi.
The European Commission granted a marketing authorisation valid throughout the European Union for Rapiscan on 6 September 2010.
Evropska komisija je dovoljenje za promet z zdravilom Rapiscan, veljavno po vsej Evropski uniji, izdala 6. septembra 2010.
It is used in adult patients (aged 18 years or over) who are unable to exercise enough for a stress test.
Uporablja se pri odraslih bolnikih (starejših od 18 let), ki ne morejo dovolj telovaditi za obremenitveni test.
Rapiscan should only be used once within any 24-hour period.
Zdravilo Rapiscan se lahko uporabi samo enkrat v 24-urnem obdobju.
What measures are being taken to ensure the safe and effective use of Rapiscan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rapiscan?
This is a summary of the European public assessment report (EPAR) for Rapiscan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rapiscan.
The full EPAR for Rapiscan can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
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.
Rapiscan must only be used in a hospital that has equipment for resuscitation and monitoring the patient.
Zdravilo Rapiscan se lahko uporablja samo v bolnišnici, ki ima na voljo opremo za oživljanje in spremljanje bolnika.
A risk management plan has been developed to ensure that Rapiscan is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Rapiscan je bil pripravljen načrt obvladovanja tveganj.
The CHMP decided that Rapiscan's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Rapiscan večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The ‘agreement rates' between the first and second scans were similar regardless of which of the two medicines were used for the second scan.
Stopnje ujemanja med prvim in drugim slikanjem so bile podobne, ne glede na to, katero zdravilo je bilo uporabljeno za drugo slikanje.
Other information about Rapiscan:
Druge informacije o zdravilu Rapiscan:
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.
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.
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.
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.
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.
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.
It is given as a 10-second injection of 400 micrograms into a vein immediately followed by an injection of sodium chloride (salt) solution.
Daje se kot 10-sekundna 400-mikrogramska injekcija v veno, kateri takoj sledi injiciranje raztopine natrijevega klorida (soli).
The main measure of effectiveness was based on the similarity between the results of the scans with Rapiscan and adenosine.
Glavno merilo učinkovitosti je temeljilo na podobnosti rezultatov slikanj z zdravilom Rapiscan in adenozinom.
The active substance in Rapiscan, regadenoson, is an A2A adenosine receptor agonist.
Zdravilna učinkovina v zdravilu Rapiscan, regadenozon, je agonist receptorja adenozina A2A.
What benefit has Rapiscan shown during the studies?
Kakšne koristi je zdravilo Rapiscan izkazalo med študijami?
They should also stop receiving dipyridamole (a medicine used to prevent blood clots) for at least two days before receiving Rapiscan.
Prav tako morajo nehati jemati dipiridamol (zdravilo za preprečevanje krvnih strdkov) vsaj dva dni pred prejetjem zdravila Rapiscan.
For more information about treatment with Rapiscan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
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.
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.
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.
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.
For further information on the use of Rapiscan, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Rapiscan glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Rapiscan is used as a ‘stress agent' that has a similar effect on the heart as exercise.
Zdravilo Rapiscan se uporablja kot „sredstvo za obremenitev“, ki ima podoben učinek na srce kot telesna vadba.
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.
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.
It is used in a type of heart scan called ‘radionuclide myocardial perfusion imaging' to see the blood flow in the heart muscle.
Uporablja se pri vrsti slikanja srca, imenovanega „radionuklidno slikanje miokardne perfuzije“ za opazovanje dotoka krvi v srčno mišico.
The results of scans using Rapiscan and adenosine were comparable.
Rezultati slikanj z uporabo zdravila Rapiscan in adenozina so bili primerljivi.
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).
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).
What is the risk associated with Rapiscan?
Kakšna tveganja so povezana z zdravilom Rapiscan?
Patients must not take any medicines or products that contain methylxanthines (such as caffeine or theophylline) for at least 12 hours before receiving Rapiscan.
Bolniki vsaj 12 ur pred dajanjem zdravila Rapiscan ne smejo uživati nobenih zdravil, ki vsebujejo metilksantine (npr. kofein ali teofilin).
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.
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.
Why has Rapiscan been approved?
Zakaj je bilo zdravilo Rapiscan odobreno?
Rapiscan is for diagnostic use only.
Zdravilo Rapiscan je samo za diagnostično uporabo.
Rapiscan is a solution for injection that contains the active substance regadenoson.
Zdravilo Rapiscan je raztopina za injiciranje, ki vsebuje zdravilno učinkovino regadenozon.
For the full list of all side effects reported with Rapiscan, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rapiscan, glejte navodilo za uporabo.
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.
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.
How has Rapiscan been studied?
Kako je bilo zdravilo Rapiscan raziskano?
How is Rapiscan used?
Kako se zdravilo Rapiscan uporablja?
What is Rapiscan?
Kaj je zdravilo Rapiscan?
What is Rapiscan used for?
Za kaj se zdravilo Rapiscan uporablja?
This enables the blood flow in the heart to be seen more easily during myocardial perfusion imaging.
Med slikanjem miokardne perfuzije je tako dotok krvi v srce bolje viden.
How does Rapiscan work?
Kako zdravilo Rapiscan deluje?
(See section 4.4)
(Glejte poglavje 4.4)
The duration of protection beyond 4 years is currently under investigation.
Raziskovanje trajanja zaščite po več kot 4 letih trenutno poteka.
If not used within 6 hours it should be discarded.
Če ni uporabljeno v 6 urah, ga je treba zavreči.
From a microbiological point of view, the vaccine should be used immediately.
Z mikrobiološkega stališča je treba cepivo uporabiti takoj.
The clinical relevance of this data is not known.
Klinična pomembnost teh podatkov ni znana.
It usually occurs in one part of the body and can last for several weeks.
Po navadi se pojavi na enem delu telesa in lahko traja več tednov.
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur na temperaturi 30 °C.
• you have a severe infection with a high temperature (fever).
• če imate hudo okužbo z visoko temperaturo (vročino).
In these cases, the vaccination may have to be postponed until you have recovered.
V takšnih primerih bo cepljenje morda treba odložiti, dokler ne okrevate.
Efficacy has not been assessed for the 0, 6-month schedule.
Učinkovitost ni bila ocenjena za shemo 0 in 6 mesecev.
The first injection can be given from the age of 50 years onwards.
Prvo injekcijo je mogoče dati v starosti od 50. leta naprej.
Most of these reactions were not long-lasting (median duration of 2 to 3 days).
Večina teh učinkov ni trajala dolgo (mediano od 2 do 3 dni).
This medicinal product must not be mixed with other medicinal products.
Zdravila se ne sme mešati z drugimi zdravili.
§ Not statistically significant
§ Ni statistično značilno.
For adjuvant see also section 2.
Za adjuvans glejte tudi poglavje 2.
• You will receive 2 injections with an interval of 2 months.
• Dobili boste 2 injekciji v presledku 2 mesecev.
• Do not use this medicine after the expiry date which is stated on the label and carton.
• Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
Concomitant use with other vaccines is not recommended due to lack of data.
Sočasna uporaba z drugimi cepivi ni priporočljiva, zaradi pomanjkanja podatkov.
Make sure you finish the complete vaccination course.
Poskrbite, da boste dokončali celotni ciklus cepljenja.
A total of 135 adults, of whom 73
Skupno 135 odraslih, od katerih je bilo
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Z namenom izboljšanja sledljivosti bioloških zdravil morata biti ime in serijska številka uporabljenega zdravila jasno zabeležena.
Laboratory confirmation of HZ cases was not part of the study procedures.
Laboratorijska potrditev primerov HZ ni bila del postopkov študije.
Maladministration via the subcutaneous route may lead to an increase in transient local reactions.
Nepravilna uporaba subkutano lahko poveča prehodne lokalne reakcije.
A minor infection such as a cold should not be a problem, but talk to your doctor first;
Blažja okužba, na primer prehlad, ne bi smela biti težava, vendar se prej posvetujte z zdravnikom,
Speak to your doctor for more information.
Za več informacij se posvetujte z zdravnikom.
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.
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.
Powder (gE antigen):
Prašek (antigen gE):
Most of these side effects are mild to moderate in intensity and are not long-lasting.
Večina teh neželenih učinkov je blagih do zmernih in niso dolgotrajni.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2018
Datum prve odobritve: 21. marec 2018
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.
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.
Very common headache
Zelo pogosti glavobol