natgillin/translations-raw huggingface dataset:
This reduces symptoms of schizophrenia and prevents them from returning.
S tem se zmanjšajo simptomi shizofrenije in prepreči njihov ponoven pojav.
Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (hearing or seeing things that are not there).
Shizofrenija je duševna bolezen s simptomi, kot so blodnje, neorganizirano mišljenje in govor, sumničavost in halucinacije (bolnik vidi in sliši stvari, ki jih ni).
As well as studies showing that Reagila improves the positive symptoms of schizophrenia both in the short and longer term, one study also showed that the medicine improved the negative symptoms of the disease which have a large impact on patients' quality of life.
Poleg študij, ki so dokazale, da zdravilo Reagila kratko- in dolgoročno izboljša pozitivne simptome shizofrenije, je ena študija pokazala tudi, da zdravilo izboljša negativne simptome bolezni, ki imajo velik vpliv na kakovost življenja bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reagila 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 Reagila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Since dopamine and serotonin play a role in schizophrenia, by attaching to their receptors, cariprazine helps normalise the activity of the brain.
Ker imata dopamin in serotonin vlogo pri shizofreniji, kariprazin z vezavo na njune receptorje pripomore k normalizaciji delovanja možganov.
The active substance in Reagila, cariprazine, attaches to receptors (targets) in the brain for two neurotransmitters called dopamine and serotonin, which nerve cells use to communicate with neighbouring cells.
Zdravilna učinkovina v zdravilu Reagila, kariprazin, se v možganih veže na receptorje (prijemališča) za dva živčna prenašalca, imenovana dopamin in serotonin, ki ju živčne celice uporabljajo za komuniciranje s sosednjimi celicami.
What benefits of Reagila have been shown in studies?
Kakšne koristi je zdravilo Reagila izkazalo v študijah?
What is Reagila and what is it used for?
Kaj je zdravilo Reagila in za kaj se uporablja?
The most common side effects with Reagila are akathisia (a constant urge to move) and parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement).
Najpogostejši neželeni učinki zdravila Reagila so akatizija (neprestana potreba po gibanju) in parkinsonizem (učinki, podobni parkinsonovi bolezni, kot so tresenje, mišična okorelost in počasno premikanje).
For more information about treatment with Reagila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Reagila preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Finally, a fifth main study in 200 patients showed that Reagila was more effective than placebo at preventing symptoms from coming back after initial treatment.
Peta glavna študija pri 200 bolnikih je pokazala tudi, da je zdravilo Reagila učinkovitejše od placeba pri preprečevanju ponovnega pojava simptomov po začetnem zdravljenju.
Why is Reagila approved?
Zakaj je bilo zdravilo Reagila odobreno?
In three main studies in a total of 1,795 adults, Reagila was more effective than placebo (a dummy treatment) at reducing symptoms on a standard rating scale called PANSS (positive and negative syndrome scale).
V treh glavnih študijah pri skupaj 1 795 odraslih je bilo zdravilo Reagila učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri zmanjševanju simptomov na standardni ocenjevalni lestvici PANSS (lestvica za ocenjevanje pozitivnega in negativnega sindroma).
What are the risks associated with Reagila?
Kakšna tveganja so povezana z zdravilom Reagila?
After 6 weeks, depending on the study, the PANSS score fell by 17 to 23 points with Reagila compared with 9 to 14 points with placebo.
Po 6 tednih se je po jemanju zdravila Reagila rezultat po lestvici PANSS znižal, odvisno od študije, za 17 do 23 točk, v primerjavi z 9 do 14 točkami pri jemanju placeba.
It is not intended to provide practical advice on how to use Reagila.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Over a 72 week period, symptoms returned in a quarter of patients taking Reagila compared with around half of those taking placebo.
V 72-tedenskem obdobju so se simptomi ponovno pojavili pri četrtini bolnikov, ki so jemali zdravilo Reagila, in pri polovici bolnikov, ki so prejemali placebo.
For practical information about using Reagila, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Reagila naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The dose can be increased by 1.5 mg at a time up to a maximum of 6 mg per day.
Priporočeni začetni odmerek je 1,5 mg enkrat na dan. Odmerek se lahko povečuje po 1,5 mg do največjega odmerka 6 mg na dan. Vzdrževati je treba najmanjši odmerek, ki je za bolnika učinkovit.
For the full list of all side effects and restrictions with Reagila, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Reagila glejte navodilo za uporabo.
Reagila contains the active substance cariprazine.
Zdravilo Reagila vsebuje zdravilno učinkovino kariprazin.
A fourth main study in 461 patients who mostly had ‘negative' symptoms (such as lack of drive, social withdrawal, and problems with attention and memory) and only few ‘positive' symptoms (such as delusions and hallucinations) showed that Reagila was effective at treating negative symptoms: after 26 weeks of treatment Reagila lowered the PANSS score for negative symptoms by around 9 points compared with around 7 points with another medicine, risperidone.
Četrta glavna študija pri 461 bolnikih, ki so imeli predvsem „negativne“ simptome (kot so pomanjkanje zagona, socialni umik ter težave s pozornostjo in spominom) in le nekaj „pozitivnih“ simptomov (kot so blodnje in halucinacije), je pokazala, da je zdravilo Reagila učinkovito pri zdravljenju negativnih simptomov.
Studies showed that Reagila improves symptoms of schizophrenia and prevents symptoms from returning.
Študije so pokazale, da zdravilo Reagila izboljša simptome shizofrenije in prepreči njihov ponoven pojav.
Reagila can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Reagila je le na recept.
How is Reagila used?
Kako se zdravilo Reagila uporablja?
How does Reagila work?
Kako zdravilo Reagila deluje?
There is a sun (for the morning) and a moon (for the evening).
Na omotu sta sonce (za jutro) in mesec (za večer).
This can be very dangerous because:
To je lahko zelo nevarno, ker:
Date of first authorisation: 03 December 2010 Date of latest renewal: 17 July 2015
Datum prve odobritve: 03 december 2010 Datum zadnjega podaljšanja: 17 julij 2015
• Stir and drink immediately.
• Zmešajte in takoj popijte.
KM percentage calculated at 36 months.
KM odstotek, izračunan po 36 mesecih.
If bleeding occurs other appropriate supportive measures should be taken.
Če se pojavi krvavitev, je treba uporabiti druge ustrezne podporne ukrepe.
You have been given this medicine because you have had:
To zdravilo ste dobili, ker ste imeli:
For further details see section 4.8.
Za dodatne podrobnosti glejte poglavje 4.8.
• Take this medicine around the same time every day (for example, one tablet in the morning and one in the evening).
• To zdravilo vzemite vsak dan ob približno istem času (npr. eno tableto zjutraj in eno zvečer).
Nominal significance value; all others are formally statistically significant by pre-defined hierarchical testing.
nominalna vrednost značilnost; vsi drugi so formalno statistično značilni po vnaprej opredeljenem hierarhičnem testiranju.
• a heart attack, over a year ago.
• srčni infarkt pred več kot enim letom.
Your doctor will decide if it needs treatment or further investigations.
Zdravnik bo presodil, ali je potrebno zdravljenje ali nadaljnje preiskave.
Bleeding may occur in any part of the body.
Krvavitev se lahko pojavi kjer koli v telesu.
Fatal: A bleeding event that directly led to death within 7 days.
Smrtne: Krvavitev, ki je neposredno povzročila smrt v 7 dneh.
This will tell you whether you have taken the dose.
Tako boste videli, ali ste odmerek že vzeli.
Your doctor will discuss with you the benefits and risks of taking Brilique during this time.
Zdravnik se bo z vami pogovoril o koristih in tveganjih jemanja zdravila Brilique med tem časom.
9.0% 0.0043 (s)
9,0 % 0,0043 (z)
Therefore, premature discontinuation of treatment should be avoided.
Zato se je treba izogniti prezgodnjemu prenehanju zdravljenja.
Children and adolescents Brilique is not recommended for children and adolescents under 18 years.
Otroci in mladostniki Zdravilo Brilique ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
Sun/Moon symbol
simbol sonce/mesec
Brilique is available in:
Zdravilo Brilique je na voljo v:
Thus, no particular group was identified at risk for any subset of bleeding.
Tako niso identificirali nobene posebne skupine s tveganjem kakšne podskupine krvavitev.
• Put the tablet on your tongue and let it disintegrate.
• Položite tableto na jezik in pustite, da se raztopi.
Holter substudy:
Holterska podštudija:
Figure 1 shows the estimate of the risk to the first occurrence of any event in the composite efficacy endpoint.
Slika 1 kaže oceno tveganja do prvega pojava kateregakoli dogodka v sestavljeni končni točki učinkovitosti.
• Feeling short of breath - this is very common.
• Kratko sapo - to je zelo pogosto.
• rifampicin (an antibiotic)
• rifampicin (antibiotik)
Creatinine increases of >50% from baseline.)
Zvišanje kreatinina za > 50 % od izhodiščne vrednosti.)
• You have had a blood test that showed more than the usual amount of uric acid.
• če ste imeli preiskavo krvi, ki je pokazala več kot običajno količino sečne kisline.
These small changes are considered of minimal clinical significance; therefore, ticagrelor can be given with or without food.
Te majhne spremembe veljajo za minimalno klinično pomembne, zato je ticagrelor mogoče jemati s hrano ali brez nje.
Therefore, in the absence of data, treatment beyond one year is not recommended in these patients.
Ker podatkov o več kot enoletnem zdravljenju ni, zdravila pri teh bolnikih ni priporočljivo uporabljati.
Frequency categories are defined according to the following conventions: Very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Your doctor may want you to stop taking this medicine 5 days prior to surgery.
Zdravnik vam bo morda naročil, da 5 dni pred operacijo nehate jemati to zdravilo.
• Pour the powder into half a glass of water.
• Prašek vsujte v pol kozarca vode.
90% of patients had final extent IPA>70% by 2 hours post dose.
90 % bolnikov je imelo končno IPA do 2. ure po odmerku > 70 %.
If a switch is needed, the first dose of Brilique should be administered 24 hours following the last dose of the other antiplatelet medication.
Če je potreben prehod, je treba prvi odmerek zdravila Brilique dati 24 ur po zadnjem odmerku drugega antiagregacijskega zdravila.
• Your doctor may require a sample of your blood for diagnostic tests if they suspect a rare platelet disorder caused by heparin.
• Zdravnik bo morda potreboval vzorec vaše krvi za izvedbo diagnostične preiskave, če bo posumil na redko motnjo trombocitov, ki jo povzroča heparin.
It is not recommended to use Brilique if you are pregnant or may become pregnant.
Zdravila Brilique ni priporočljivo uporabljati, če ste noseči ali bi lahko zanosili.
• You can then swallow it with or without water.
• Zaužijete jo lahko z vodo ali brez nje.
• You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na ticagrelor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
PLATO study (Acute Coronary Syndromes)
Študija PLATO (akutni koronarni sindromi)
• Blood in your ear
• kri v ušesu
• Active pathological bleeding.
• Aktivna patološka krvavitev.
Ticagrelor may be resumed after the cause of bleeding has been identified and controlled.
Uporaba ticagrelorja se lahko nadaljuje, ko je vzrok krvavitve ugotovljen in obvladan.
• You have had any problems with your liver or have previously had any disease which may have affected your liver.
• če imate ali ste kdaj imeli težave z jetri, ali ste kdaj v preteklosti imeli kakšno bolezen, ki bi lahko prizadela jetra.
Your doctor will tell you how much to take (usually between 75-150 mg daily).
Zdravnik vam bo povedal, koliko zdravila morate jemati (po navadi med 75 in 150 mg na dan).
• Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not already have in place a device that paces your heart (pacemaker).
• če imate nenormalno počasen srčni utrip (po navadi manj kot 60 utripov na minuto) in še nimate nameščene naprave, ki spodbuja srce (spodbujevalnika).
Effects of medicinal and other products on ticagrelor
Učinki zdravil in drugih snovi na ticagrelor
Ticagrelor is not recommended during pregnancy.
Ticagrelorja ni priporočljivo uporabljati med nosečnostjo.
This is because Brilique can affect the way some medicines work and some medicines can have an effect on Brilique.
Zdravilo Brilique namreč lahko vpliva na delovanje nekaterih zdravil in nekatera zdravila lahko vplivajo na zdravilo Brilique.
Note: the number of first events for the components CV death, MI and stroke are the actual number of first events for each component and do not add up to the number of events in the composite endpoint (s) Indicates statistical significance.
Opomba: števila prvih dogodkov elementov KV smrti, MI in možganske kapi so dejanska števila prvih dogodkov za vsak element in se ne seštejejo do števila dogodkov v sestavljenem opazovanem dogodku, (z) označuje statistično značilnost.
If you are taking both Brilique and heparin:
Če jemljete tako zdravilo Brilique kot heparin:
This reduces the chance of a blood clot forming that can reduce blood flow.
Tako se zmanjša verjetnost nastanka krvnega strdka, ki lahko zmanjša pretok krvi.
• more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high cholesterol)
• več kot 40 mg simvastatina ali lovastatina na dan (zdravili za zdravljenje visokega holesterola)
In the event of an overdose, the above potential adverse reactions could occur and ECG monitoring should be considered.
V primeru prevelikega odmerjanja se lahko pojavijo zgoraj omenjeni možni neželeni učinki in v poštev je potrebno vzeti EKG-nadzor.
Exposure of the active metabolite increased to a lesser extent (AUC 13-14% and Cmax 17-36%).
Izpostavljenost aktivnemu presnovku se je povečala v manjši meri (AUC 13-14 % in Cmax 17-36 %).
Ticagrelor may have similar effect on lovastatin.
Ticagrelor morda podobno vpliva na lovastatin.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that increase your risk of bleeding:
Še zlasti morate zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil, ki povečajo tveganje krvavitev:
Premature discontinuation
Prezgodnje prenehanje
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
TTP je lahko življenjsko nevarna in zahteva takojšnje zdravljenje, vključno s plazmaferezo.
• morphine and other opioids (used to treat severe pain)
• morfin in druge opioide (uporabljajo se za zdravljenje hude bolečine).
Do not stop taking Brilique without talking to your doctor.
Ne prenehajte jemati zdravila Brilique, ne da bi se posvetovali z zdravnikom.
Ticagrelor has no or negligible influence on the ability to drive and use machines.
Ticagrelor nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• You have asthma or other lung problems or breathing difficulties.
• če imate astmo, druge težave s pljuči ali težave z dihanjem.
Renal function should be checked according to routine medical practice.
Delovanje ledvic je treba preverjati v skladu z običajno medicinsko prakso.
ASA alone N = 7067
Samo ASA N = 7067
ARR (%/yr)
ARR (%/leto)
A patient who misses a dose of Brilique should take only one tablet (their next dose) at its scheduled time.
Če bolnik izpusti odmerek zdravila Brilique, naj vzame le eno tableto (svoj naslednji odmerek) ob predvidenem času.
• Visual problems caused by blood in your eye
• težave z vidom zaradi krvi v očesu
Combined efficacy and safety composite
Kombinirana učinkovitost in varnost skupaj
This interaction may be related to reduced gastrointestinal motility and apply to other opioids.
To medsebojno delovanje je morda posledica zmanjšane motilitete prebavil in velja tudi za druge opioide.
It is important that you inform your doctor that you are taking both Brilique and heparin, as Brilique may affect the diagnostic test.
Pomembno je, da zdravnika obvestite, da jemljete tako zdravilo Brilique kot heparin, kajti zdravilo Brilique lahko vpliva na to diagnostično preiskavo.
The orodispersible tablets may be used as an alternative to Brilique 90 mg film-coated tablets for patients who have difficulty swallowing the tablets whole or for whom there is a preference for orodispersible tablets.
Orodisperzibilne tablete je mogoče uporabiti kot alternativo za filmsko obložene tablete zdravila Brilique jakosti 90 mg pri bolnikih, ki imajo težave z zaužitjem celih tablet ali ki dajejo prednost orodisperzibilnim tabletam.
AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA United Kingdom
AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA Velika Britanija
Other medicines and Brilique
Druga zdravila in zdravilo Brilique
The systemic exposure to the active metabolite is approximately 30-40% of that obtained for ticagrelor.
Sistemska izpostavljenost aktivnemu presnovku je približno 30 do 40 % tiste, ki je dosežena s ticagrelorjem.
• Fainting (syncope) - a temporary loss of consciousness due to sudden drop in blood flow to the brain (common)
• Omedlevica (sinkopa) - začasna izguba zavesti zaradi nenadnega zmanjšanja dotoka krvi v možgane (pogost učinek)
Take this medicine on a regular basis and for as long as your doctor keeps prescribing it.
To zdravilo jemljite redno in toliko časa, kot vam ga zdravnik predpisuje.
KM% p-value
KM % Vrednost p
The tablet should be placed on the tongue, where it will rapidly disperse in saliva.
Bolnik mora tableto položiti na jezik, kjer se v slini hitro raztopi.
Patients taking Brilique should also take a daily low maintenance dose of ASA 75-150 mg, unless specifically contraindicated.
Bolniki, ki jemljejo zdravilo Brilique, morajo vsak dan vzeti tudi majhen vzdrževalni odmerek ASA (75-150 mg), če ta ni izrecno kontraindicirana.
Clinical efficacy and safety The clinical evidence for the efficacy and safety of ticagrelor is derived from two phase 3 trials:
Klinični dokazi o učinkovitosti in varnosti ticagrelorja izvirajo iz dveh preskušanj 3. faze:
• Feeling dizzy or like the room is spinning
• omotica ali občutek, kot da se prostor vrti
If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.
Če med jemanjem tega zdravila občutite omotico ali zmedenost, bodite previdni pri upravljanju vozil in strojev.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ticagrelor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja s ticagrelorjem, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
This belongs to a group of medicines called antiplatelet medicines.
To zdravilo spada v skupino zdravil, imenovanih antiagregacijska zdravila.
The mechanism for uterine tumours is likely hormonal imbalance which can lead to tumours in rats.
Mehanizem nastanka tumorjev maternice je verjetno hormonsko neravnovesje, ki lahko pri podganah povzroči tumorje.
Treatment can also be initiated up to 2 years from the MI, or within one year after stopping previous ADP receptor inhibitor treatment.
Zdravljenje se lahko začne tudi do 2 leti po miokardnem infarktu ali v enem letu po prenehanju predhodnega zdravljenja z zaviralcem receptorjev ADP.
Ticagrelor also increases local endogenous adenosine levels by inhibiting the equilibrative nucleoside transporter-1 (ENT-1).
Ticagrelor poveča tudi lokalno koncentracijo endogenega adenozina z zavrtjem ravnotežnega nukleozidnega prenašalca 1 (ENT-1 - equilibrative nucleoside transporter-1).
Recoveries of ticagrelor and the active metabolite in urine were both less than 1% of the dose.
Pojavljanje ticagrelorja in aktivnega presnovka v urinu je bilo za oba manj kot 1 % odmerka.
The safety profile of ticagrelor has been evaluated in two large phase 3 outcome trials (PLATO and PEGASUS) including more than 39,000 patients (see section 5.1).
Varnostne značilnosti ticagrelorja so ocenili v dveh velikih preskušanjih izidov 3. faze (PLATO in PEGASUS), ki sta zajeli več kot 39.000 bolnikov (glejte poglavje 5.1).
Ticagrelor produced irregular cycles (mostly extended cycles) in female rats, but did not affect overall fertility in male and female rats.
Ticagrelor je pri podganjih samicah povzročil neredne cikluse (večinoma podaljšane), ni pa vplival na celotno plodnost podganjih samcev ali samic.
Therefore, patients who experience these symptoms should be cautious while driving or using machines.
Bolniki, pri katerih se pojavita ta dva simptoma, naj bodo zato previdni pri vožnji ali upravljanju s stroji.
Taking Brilique with other medicines for blood clotting
Jemanje zdravila Brilique z drugimi zdravili proti strjevanju krvi
If the association cannot be avoided, their concomitant use should be made with caution.
Če se hkratni uporabi ni mogoče izogniti, mora biti sočasno zdravljenje previdno.
Also tell your doctor that because you are taking Brilique, you may have an increased risk of bleeding if your doctor gives you fibrinolytics, often called ‘clot dissolvers', such as streptokinase or alteplase.
Zdravniku tudi povejte, da imate lahko zaradi jemanja zdravila Brilique večje tveganje za krvavitev, če vam zdravnik da fibrinolitike (pogosto jih imenujejo tudi "zdravila za raztapljanje strdkov"), kakršna sta streptokinaza ali alteplaza.
• a heart attack, or
• srčni infarkt ali
What you need to know before you take Brilique
Kaj morate vedeti, preden boste vzeli zdravilo Brilique
• Allergic reaction - a rash, itching or a swollen face or swollen lips/tongue may be signs of an allergic reaction
• alergijska reakcija - izpuščaj, srbenje ali otekel obraz ali otekle ustnice/jezik so lahko znak alergijske reakcije
The small difference in Cmax noted is unlikely to be of clinical relevance.
Ni verjetno, da bi bila majhna opažena razlika v Cmax klinično pomembna.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.8).
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.8).
• The usual dose is one tablet of 60 mg twice a day.
• Običajen odmerek je ena 60 mg tableta dvakrat na dan.