natgillin/translations-raw huggingface dataset:
*compared to placebo
*v primerjavi s placebom
The mechanism for this increased risk is not known.
Mehanizem tega povečanja ni znan.
Of the 2,844 patients 933 were female (see section 4.2).
Med 2.844 bolniki je bilo 933 žensk (glejte poglavje 4.2).
Estimated Treatment Difference
Ocenjena razlika zdravljenja
Some of these patients had confounding factors.
Nekateri od teh bolnikov so imeli sočasne dejavnike.
The safety and efficacy of cariprazine in children and adolescents aged less than 18 years have not been established.
Varnost in učinkovitost kariprazina pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The primary outcome of the study was time to relapse.
Primarni opazovani dogodek študije je bil čas do ponovitve.
Consequently, newborns should be monitored carefully.
Novorojence je zato treba pozorno spremljati.
Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Ne vozite in ne upravljajte orodij ali strojev, dokler niste prepričani, da to zdravilo na vas ne vpliva negativno.
Your doctor will advise you to visit an ophthalmologist.
Zdravnik vam bo svetoval, da obiščete oftalmologa.
This analysis included 2,844 patients of different races, involving 536 patients between the ages of 50 and 65.
V to analizo je bilo vključenih 2.844 bolnikov različnih etničnih pripadnosti, vključno s 536 bolniki, starimi od 50 do 65 let.
Cariprazine can be administered with or without food.
Kariprazin se lahko daje s hrano ali brez nje.
An increased risk cannot be excluded for other antipsychotics or other patient populations.
Povečanja tveganja za ostale antipsihotike ali druge populacije bolnikov ni mogoče izključiti.
The maximum dose should not exceed 6 mg once a day.
Največji odmerek ne sme preseči 6 mg enkrat na dan.
If your doctor decides that you should take this medicine during pregnancy, your doctor will monitor your baby closely after birth.
Če se zdravnik odloči, da naj to zdravilo jemljete med nosečnostjo, bo zdravnik vašega otroka po rojstvu skrbno spremljal.
(See section “Pregnancy and breastfeeding”).
(Glejte poglavje „Nosečnost in dojenje“).
Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias.
Takoj je treba uvesti kardiovaskularno spremljanje, vključno s stalnim elektrokardiografskim spremljanjem možnih aritmij.
In elderly patients above 65 years of age data are limited.
Podatki pri starejših bolnikih, starih več kot 65 let, so omejeni.
The effect of food on the exposure of the metabolites DCAR and DDCAR was also minimal.
Tudi učinek hrane na izpostavljenost presnovkom DCAR in DDCAR je bil minimalen.
Tell your doctor immediately if you notice any signs of a stroke.
Zdravniku takoj povejte, če opazite kakršne koli znake možganske kapi.
These may be signs of muscle damage which can cause very serious kidney problems.
To so lahko znaki poškodbe mišic, ki lahko povzroči zelo resne težave z ledvicami.
Smoking status
Status kajenja
Consumption of grapefruit juice should be avoided.
Izogibati se je treba uživanju soka grenivke.
This is because the medicine will stay in your body for some time after the last dose was taken.
Vzrok je v tem, ker zdravilo v telesu ostane še nekaj časa po zadnjem odmerku.
The lowest effective dose should be maintained according to the clinical judgement of the treating physician.
Treba je vzdrževati najmanjši učinkovit odmerek v skladu s klinično presojo lečečega zdravnika.
Do not take this medicine during pregnancy unless your doctor has told you to do so.
Tega zdravila ne jemljite med nosečnostjo, razen če vam je tako naročil zdravnik.
Do not take Reagila: - if you are allergic to cariprazine or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Reagila: - če ste alergični na kariprazin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Even if you feel better, do not alter or stop your daily dose of Reagila unless told to do so by your doctor as your symptoms may return.
Tudi če se počutite bolje, ne spreminjajte dnevnega odmerka zdravila Reagila in ga ne prenehajte jemati, če vam tega ni naročil zdravnik, saj se lahko vaši simptomi vrnejo.
For the management of patients treated with cariprazine, the effective half-life is more relevant than the terminal half-life.
Za obravnavo bolnikov, zdravljenih s kariprazinom, je učinkovita razpolovna doba bolj pomembna kot končna razpolovna doba.
These symptoms may occur early during treatment with Reagila.
Ti simptomi se lahko pojavijo zgodaj med zdravljenjem z zdravilom Reagila.
Most events were mild to moderate in severity.
Večina dogodkov je bila blagih do zmernih.
Results for the primary outcome parameter are summarized in Table 1 below.
Rezultati parametrov primarnega opazovanega dogodka so povzeti spodaj v preglednici 1.
Thereafter, the dose may be slowly adjusted by your doctor, in steps of 1.5 mg, depending on how the treatment works for you.
Nato lahko zdravnik počasi odmerek prilagodi v korakih po 1,5 mg, kar je odvisno od tega, kako zdravljenje deluje pri vas.
Reagila should not be used by elderly patients with dementia (loss of memory).
Zdravilo Reagila se ne sme uporabljati pri starejših bolnikih z demenco (izgubljanjem spomina).
Tell your doctor immediately: - if you are having any thoughts or feelings about hurting yourself or to commit suicide.
Zdravniku takoj povejte: - če imate kakršne koli misli ali občutke o samopoškodovanju ali o tem, da bi storili samomor.
- high or low blood pressure, cardiovascular disease.
- imate visok ali nizek krvni tlak, srčno-žilno bolezen.
Because cariprazine is not a substrate for CYP1A2, smoking is not expected to have an effect on the pharmacokinetics of cariprazine.
Ker kariprazin ni substrat za CYP1A2, ni pričakovati, da bi kajenje vplivalo na farmakokinetiko kariprazina.
This patient experienced orthostasis and sedation.
Ta bolnik je bil ortostatičen in sediran.
Cariprazine and its major active metabolites are highly bound (96 to 97% for CAR, 94% to 97% for DCAR and 92% to 97% for DDCAR) to plasma proteins.
Kariprazin in njegova glavna aktivna presnovka se obsežno vežejo (96 do 97 % za CAR, 94 % do 97 % za DCAR in 92 % do 97 % za DDCAR) na beljakovine v plazmi.
None of the cariprazine treated patients had any liver damage.
Noben od bolnikov, zdravljenih s kariprazinom, ni imel poškodb na jetrih.
Blood pressure changes
Spremembe krvnega tlaka
Detailed and updated information on this medicine is available by scanning the QR code below and the outer carton with a smartphone.
Podrobne in posodobljene informacije o zdravilu so na voljo s skeniranjem kode QR spodaj in na škatli s pametnim telefonom.
What Reagila is and what it is used for
Kaj je zdravilo Reagila in za kaj ga uporabljamo
Results for the secondary outcome parameter (CGI) and additional endpoints were supportive of the primary endpoint.
Rezultati parametrov sekundarnega opazovanega dogodka (CGI) in dodatnih opazovanih dogodkov podpirajo primarni opazovani dogodek.
Patients with secondary negative symptoms, such as moderate to severe depressive symptoms and clinically relevant parkinsonism (EPS) were excluded.
Bolniki s sekundarnimi negativnimi simptomi, kot so zmerni do hudi simptomi depresije, in klinično pomembnim parkinsonizmom (EPS) so bili izključeni.
The effective (functional) half-life is ~ 2 days for cariprazine and DCAR, 8 days for DDCAR and is ~1 week for total cariprazine.
Učinkovita (funkcionalna) razpolovna doba je ~ 2 dni za kariprazin ter DCAR, 8 dni za DDCAR in ~ 1 teden za skupni kariprazin.
Given the primary central nervous system effects of cariprazine, Reagila should be used with caution in combination with other centrally acting medicinal products and alcohol.
Glede na primarne učinke kariprazina na osrednji živčni sistem je potrebna previdnost pri uporabi zdravila Reagila v kombinaciji z drugimi zdravili s centralnim delovanjem in alkoholom.
Most EPS cases were mild to moderate in intensity and could be handled with common anti-EPS medicinal products.
Večina primerov EPS je bila blagih do zmernih po intenzivnosti in obvladljivih z običajnimi zdravili proti EPS.
Allura red AC is a coloring agent, which may cause allergic reactions.
Alurno rdeče AC je barvilo, ki lahko povzroči alergijske reakcije.
Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with Reagila does not affect them adversely.
Bolnike je treba opozoriti, da nevarnih strojev, vključno z motornimi vozili, ne upravljajo, dokler se ne prepričajo, da zdravilo Reagila nanje nima neželenih vplivov.
These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases, neonates have required intensive care unit support and prolonged hospitalization.
Resnost teh zapletov je bila različna; v nekaterih primerih so simptomi izzveneli sami, v drugih primerih pa je bilo treba novorojence zdraviti v intenzivni enoti, ob dolgi hospitalizaciji.
Your doctor will need to check your blood pressure regularly.
Zdravnik bo moral redno preverjati vaš krvni tlak.
These can be the signs of the so-called neuroleptic malignant syndrome.
To so lahko znaki tako imenovanega nevroleptičnega malignega sindroma.
The clinical consequences of this effect is not fully understood, however the use of P-gp substrates with narrow therapeutic index such as dabigatran and digoxin could require extra monitoring and dose adjustment.
Klinične posledice tega učinka niso povsem razumljene, vendar bo morda treba pri uporabi substratov P-gp z ozkim terapevtskim indeksom, kot sta dabigatran in digoksin, bolnika dodatno spremljati in prilagoditi odmerek.
The rate of discontinuation due to EPS related ADRs was low.
Stopnja prekinitve zaradi neželenih učinkov, povezanih z EPS, je bila majhna.
Reproductive performance of the first generation pups was unaffected; however, second generation pups also had similar clinical signs and lower body weight.
Reproduktivna funkcija mladičev prve generacije ni bila prizadeta, vendar pa so imeli tudi mladiči druge generacije podobne klinične znake in manjšo telesno maso.
Available data in elderly patients aged ≥65 years treated with cariprazine are not sufficient to determine whether or not they respond differently from younger patients (see section 5.2).
Razpoložljivi podatki pri starejših bolnikih, starih ≥ 65 let, zdravljenih s kariprazinom, ne zadoščajo za ugotovitev, ali se njihov odziv razlikuje od odziva pri mlajših bolnikih (glejte poglavje 5.2).
Patients with kidney or liver problems
Bolniki s težavami z ledvicami ali jetri
Reagila may cause significant weight increase which may affect your health.
Povečanje telesne mase Zdravilo Reagila lahko povzroči znatno povečanje telesne mase, kar lahko vpliva na vaše zdravje.
Blood pressure should be monitored.
Krvni tlak je potrebno nadzorovati.
Management of overdose should concentrate on supportive therapy including maintenance of an adequate airway, oxygenation and ventilation and management of symptoms.
Obvladovanje prevelikega odmerjanja naj se osredotoča na podporno zdravljenje, vključno z ohranjanjem zadostnih dihalnih poti, oksigenacijo in ventilacijo, in na obvladovanje simptomov.
° anaemia (reduced levels of red blood cells)
° anemija (zmanjšano število rdečih krvničk)
Take Reagila at the same time each day with or without food.
Zdravilo Reagila jemljite vsak dan ob istem času s hrano ali brez nje.
The mechanism of action of cariprazine is not fully known.
Mehanizem delovanja kariprazina ni povsem znan.
Dose selection for an elderly patient should be more cautious.
Odmerek je treba pri starejših bolnikih izbrati bolj previdno.
Studies in animals have shown reproductive toxicity including developmental malformations in rats (see section 5.3).
Študije pri živalih so pokazale reproduktivno toksičnost, vključno z razvojnimi malformacijami pri podganah (glejte poglavje 5.3).
° increase in a type of white blood cells
° povečanje števila vrste belih krvnh celic
Elevated liver transaminases (ALT, AST) are frequently observed with antipsychotic treatment.
Zvišane vrednosti jetrnih transaminaz (ALT, AST) so pri antipsihotičnem zdravljenju pogoste.
It is used to treat adults with schizophrenia.
Uporablja se za zdravljenje odraslih, ki imajo shizofrenijo.
Cariprazine has not been studied in elderly patients with dementia and is not recommended to treat elderly patients with dementia due to increased risk of overall mortality.
Kariprazina niso preučili pri starejših bolnikih z demenco, zato se zaradi večjega tveganja za umrljivost zdravljenje starejših bolnikov z demenco ne priporoča.
Time to relapse (92 vs. 326 days-based on the 25th percentile) was therefore significantly longer in the cariprazine group than in the placebo group (p=0.009).
Čas do ponovitve (92 v primerjavi s 326 dnevi na podlagi 25. percentila) je bil tako značilno daljši v skupini s kariprazinom kot v skupini s placebom (p = 0,009).
Therefore, cataract formation was closely monitored with slit lamp examinations in the clinical studies and patients with existing cataracts were excluded.
Zato so v kliničnih študijah razvoj katarakte natančno spremljali s pregledi s špranjsko svetilko, bolnike z obstoječo katarakto pa izključili.
The possibility of suicidality (suicidal ideation, suicide attempt and completed suicide) is inherent in psychotic illnesses and, generally, it is reported early after initiation or switch of antipsychotic therapy.
Možnost samomorilnosti (samomorilne misli, poskus samomora in izvršen samomor) spremlja psihotične bolezni in o njej običajno poročajo ob uvedbi ali zamenjavi antipsihotičnega zdravljenja.
The most commonly reported ocular adverse event was blurred vision (placebo: 1/683; 0.1%, cariprazine: 22/2048; 1.1%).
Očesni neželeni dogodek, o katerem so najpogosteje poročali, je bil zamegljen vid (placebo: 1/683; 0,1 %, kariprazin: 22/2048; 1,1 %).
Reagila contains the active substance cariprazine and belongs to a group of medicines called antipsychotics.
Zdravilo Reagila vsebuje učinkovino kariprazin in sodi v skupino zdravil, imenovanih antipsihotiki.
Table 2 Summary of results in study RGH-188-005
Povzetek rezultatov študije RGH-188-005R Parametri učinkovitosti
Contact your doctor for advice.
Za nasvet se obrnite na zdravnika.
If you have serious kidney or liver problems Reagila may not be appropriate for you.
Če imate resne težave z ledvicami ali jetri, morda zdravilo Reagila ni primerno za vas.
Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX15
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Psiholeptiki, drugi antipsihotiki, oznaka ATC: N05AX15
It is unknown whether cariprazine or its major active metabolites are excreted in human milk.
Ni znano, ali se kariprazin ali njegovi glavni aktivni presnovki izločajo v materino mleko.
Therefore, cariprazine should be used cautiously in patients with known cardiovascular disease or in patients with a family history of QT prolongation and in patients treated with medicinal products that might cause QT prolongation (see section 5.1).
Zato je treba kariprazin uporabljati previdno pri bolnikih z znano kardiovaskularno boleznijo ali pri bolnikih s podaljšanjem intervala QT v družinski anamnezi ter pri bolnikih, zdravljenih z zdravili, ki lahko povzročijo podaljšanja intervala QT (glejte poglavje 5.1).
The European Medicines Agency has deferred the obligation to submit the results of studies with cariprazine in paediatric population.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Reagila za pediatrično populacijo.
Holter monitor-derived electrocardiographic assessments were obtained in 129 patients over a twelve hour period at baseline and steady state.
Ocene, izpeljane iz Holter-elektrokardiografije, so pridobili pri 129 bolnikih v obdobju dvanajst ur ob izhodišču in v stanju ravnovesja.
It should be considered that plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week (see section 5.2).
Upoštevati je treba, da se koncentracije kariprazina in njegovih aktivnih presnovkov v plazmi zmanjšajo za 50 % v ~1 tednu (glejte poglavje 5.2).
95%CI
(95-% IZ)
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with cariprazine and preventive measures undertaken.
Bolniki, ki prejemajo antipsihotike, imajo pogosto pridobljene dejavnike tveganja za VTE, zato je treba pred in med zdravljenjem s kariprazinom ugotoviti vse možne dejavnike tveganja in ukrepati preventivno.
Other medicines and Reagila
Druga zdravila in zdravilo Reagila
Efficacy with short-term use
Učinkovitost pri kratkotrajni uporabi
If signs and symptoms of tardive dyskinesia appear in a patient treated with cariprazine, discontinuation should be considered.
Če se znaki in simptomi tardivne diskinezije pojavijo pri bolnikih, zdravljenih s kariprazinom, je treba razmisliti o prekinitvi uporabe.
Cariprazine can cause orthostatic hypotension as well as hypertension (see section 4.8).
Kariprazin lahko povzroči ortostatsko hipotenzijo kot tudi hipertenzijo (glejte poglavje 4.8).
At steady state, exposure to DDCAR is approximately two to three-fold higher than to cariprazine, and exposure to DCAR is approximately 30% of cariprazine exposure.
V stanju ravnovesja je izpostavljenost DDCAR približno dva- do trikrat večja kot izpostavljenost kariprazinu, izpostavljenost DCAR pa je približno 30 % izpostavljenosti kariprazinu.
(Side effect with frequency not known) - thoughts or feelings about hurting yourself or to commit suicide, suicide attempt.
(Neželeni učink z neznano pogostnostjo) - misli ali občutki o tem, da bi se poškodovali ali storili samomor, poskus samomora.
Reagila is for oral use, to be taken once daily at the same time of the day with or without food.
Način uporabe Zdravilo Reagila se uporablja peroralno in jemlje enkrat na dan ob istem času dneva s hrano ali brez nje.
- irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring), and tell your doctor if you are taking other medicines, because they might cause or worsen this ECG change.
- imate nereden srčni utrip ali ima kdo drug v družini nereden srčni utrip (vključno s podaljšanjem intervala QT, kar se vidi na EKG), in povejte zdravniku, če jemljete druga zdravila, saj lahko le-ta povzročijo ali poslabšajo spremembe na EKG)
People with this condition may also feel depressed, guilty, anxious, tense, or not being able to start or keep up planned activities, unwillingness to speak, lack of emotional response to a situation that would normally stimulate feelings in others.
Ljudje s to boleznijo imajo lahko tudi občutek depresije, krivde, tesnobe, napetosti, ne morejo začeti ali izpeljati načtovanih aktivnosti, niso pripravljeni govoriti, imajo nezadosten čustven odziv na situacije, ki pri drugih izzovejo čustva.
If prescribed to patients with Parkinson's disease, antipsychotic medicinal products may exacerbate the underlying disease and worsen symptoms of Parkinson's disease.
Antipsihotična zdravila, predpisana bolnikom s Parkinsonovo boleznijo, lahko poslabšajo osnovno bolezen in simptome Parkinsonove bolezni.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, cariprazine must be discontinued immediately.
Če se pri bolniku pojavijo znaki in simptomi, značilni za NMS, ali se mu nepojasnjeno zviša telesna temperatura brez dodatnih kliničnih znakov NMS, je treba takoj prekiniti zdravljenje s kariprazinom.
Reagila is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Uporaba zdravila Reagila ni priporočljiva pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Since cariprazine is highly bound to plasma proteins, haemodialysis is unlikely to be useful in the management of overdose.
Ker se kariprazin v veliki meri veže na plazemske beljakovine, ni verjetno, da bi bila hemodializa v pomoč pri obravnavanju prevelikega odmerjanja.
Efficacy with long-term use
Učinkovitost pri dolgotrajni uporabi
This is because the following symptoms may occur in newborn babies of mothers who have used this medicine in the last trimester (last three months) of their pregnancy: - shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Razlog je v tem, da se lahko pri novorojenčkih mater, ki so v zadnjem trimesečju (zadnji trije meseci) nosečnosti jemale to zdravilo, pojavijo naslednji simptomi: - tresenje, togost mišic in/ali šibkost, zaspanost, vznemirjenost, težave z dihanjem in težave s prehranjevanjem.
Drowsiness, dizziness and vision problems may occur during treatment with this medicine (see section 4).
Med zdravljenjem s tem zdravilom se lahko pojavijo zaspanost, omotičnost in težave z vidom (glejte poglavje 4).
Elevated liver transaminases
Zvišane vrednosti jetrnih transaminaz
Patients should be monitored for adverse reactions and treatment response for several weeks after starting cariprazine and after each dosage change (see section 5.2).
Bolnike je treba spremljati glede pojava neželenih učinkov in odziva na zdravljenje še nekaj tednov po uvedbi kariprazina in po vsaki spremembi odmerka (glejte poglavje 5.2).
Prevention includes slow up-titration; treatment measures include slight down-titration of cariprazine or anti-EPS medication.
Preprečevanje vključuje počasno povečevanje odmerka; ukrepi zdravljenja vključujejo blago zmanjšanje odmerka kariprazina ali uvedba zdravila proti EPS.
Physicians should, therefore, weigh the risks versus the benefits when prescribing cariprazine to patients with Parkinson's disease.
Zdravnik mora pretehtati tveganja in koristi predpisovanja kariprazina bolnikom s Parkinsonovo boleznijo.
Your doctor will also inform you how to act if you switch from Reagila to another medicine.
Zdravnik vas bo obvestil tudi o tem, kako ravnati pri prehodu z zdravila Reagila na drugo zdravilo.
Tell your doctor immediately if you have: - a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure.
Zdravniku takoj povejte, če imate: - hudo alergijsko reakcijo, ki se kaže kot zvišana telesna temperatura, otekla usta, obraz, ustnice ali jezik, zasoplost, srbenje, kožni izpuščaj in včasih padec krvnega tlaka.
If you have taken more Reagila than your doctor has recommended or if, for example, a child has taken it by mistake, contact your doctor or go to the nearest hospital right away and take the pack of the medicine with you.
Če ste vzeli večji odmerek zdravila Reagila, kot bi smeli Če ste vzeli več zdravila Reagila, kot vam je priporočil zdravnik ali če je na primer zdravilo pomotoma vzel otrok, se takoj obrnite na zdravnika ali pojdite v najbližjo bolnišnico in vzemite škatlo tega zdravila s seboj.
There is a minor or moderate risk that the medicine could affect the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Obstaja majhno ali zmerno tveganje, da bi lahko to zdravilo vplivalo na sposobnost vožnje in upravljanja strojev.
The metabolites of HCAR, HDCAR, and HDDCAR are subsequently biotransformed to their corresponding sulfate and glucuronide conjugates.
Presnovki HCAR, HDCAR in HDDCAR se nato biotransformirajo v svoje odgovarjajoče sulfatne in glukuronidne konjugate.
QR code to be included www.reagila.com
Vključiti kodo QR www.reagila.com
Based on a population pharmacokinetic analysis, the apparent volume of distribution (V/F) was 916 L for cariprazine, 475 L for DCAR and 1,568 L for DDCAR, indicating extensive distribution of cariprazine and its major active metabolites.
Na podlagi analize populacijske farmakokinetike je bil navidezni volumen porazdelitve (V/F) 916 l za kariprazin, 475 l za DCAR in 1.568 l za DDCAR, kar kaže na obširno porazdelitev kariprazina in njegovih glavnih aktivnih presnovkov.