FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Your doctor will need to check your blood pressure regularly.
Slovenian: Zdravnik bo moral redno preverjati vaš krvni tlak.
English: These can be the signs of the so-called neuroleptic malignant syndrome.
Slovenian: To so lahko znaki tako imenovanega nevroleptičnega malignega sindroma.
English: 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.
Slovenian: 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.
English: The rate of discontinuation due to EPS related ADRs was low.
Slovenian: Stopnja prekinitve zaradi neželenih učinkov, povezanih z EPS, je bila majhna.
English: Reproductive performance of the first generation pups was unaffected; however, second generation pups also had similar clinical signs and lower body weight.
Slovenian: Reproduktivna funkcija mladičev prve generacije ni bila prizadeta, vendar pa so imeli tudi mladiči druge generacije podobne klinične znake in manjšo telesno maso.
English: 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).
Slovenian: 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).
English: Patients with kidney or liver problems
Slovenian: Bolniki s težavami z ledvicami ali jetri
English: Reagila may cause significant weight increase which may affect your health.
Slovenian: Povečanje telesne mase Zdravilo Reagila lahko povzroči znatno povečanje telesne mase, kar lahko vpliva na vaše zdravje.
English: Blood pressure should be monitored.
Slovenian: Krvni tlak je potrebno nadzorovati.
English: Management of overdose should concentrate on supportive therapy including maintenance of an adequate airway, oxygenation and ventilation and management of symptoms.
Slovenian: Obvladovanje prevelikega odmerjanja naj se osredotoča na podporno zdravljenje, vključno z ohranjanjem zadostnih dihalnih poti, oksigenacijo in ventilacijo, in na obvladovanje simptomov.
English: ° anaemia (reduced levels of red blood cells)
Slovenian: ° anemija (zmanjšano število rdečih krvničk)
English: Take Reagila at the same time each day with or without food.
Slovenian: Zdravilo Reagila jemljite vsak dan ob istem času s hrano ali brez nje.
English: The mechanism of action of cariprazine is not fully known.
Slovenian: Mehanizem delovanja kariprazina ni povsem znan.
English: Dose selection for an elderly patient should be more cautious.
Slovenian: Odmerek je treba pri starejših bolnikih izbrati bolj previdno.
English: Studies in animals have shown reproductive toxicity including developmental malformations in rats (see section 5.3).
Slovenian: Študije pri živalih so pokazale reproduktivno toksičnost, vključno z razvojnimi malformacijami pri podganah (glejte poglavje 5.3).
English: ° increase in a type of white blood cells
Slovenian: ° povečanje števila vrste belih krvnh celic
English: Elevated liver transaminases (ALT, AST) are frequently observed with antipsychotic treatment.
Slovenian: Zvišane vrednosti jetrnih transaminaz (ALT, AST) so pri antipsihotičnem zdravljenju pogoste.
English: It is used to treat adults with schizophrenia.
Slovenian: Uporablja se za zdravljenje odraslih, ki imajo shizofrenijo.
English: 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.
Slovenian: Kariprazina niso preučili pri starejših bolnikih z demenco, zato se zaradi večjega tveganja za umrljivost zdravljenje starejših bolnikov z demenco ne priporoča.
English: 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).
Slovenian: 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).
English: Therefore, cataract formation was closely monitored with slit lamp examinations in the clinical studies and patients with existing cataracts were excluded.
Slovenian: Zato so v kliničnih študijah razvoj katarakte natančno spremljali s pregledi s špranjsko svetilko, bolnike z obstoječo katarakto pa izključili.
English: 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.
Slovenian: Možnost samomorilnosti (samomorilne misli, poskus samomora in izvršen samomor) spremlja psihotične bolezni in o njej običajno poročajo ob uvedbi ali zamenjavi antipsihotičnega zdravljenja.
English: The most commonly reported ocular adverse event was blurred vision (placebo: 1/683; 0.1%, cariprazine: 22/2048; 1.1%).
Slovenian: Očesni neželeni dogodek, o katerem so najpogosteje poročali, je bil zamegljen vid (placebo: 1/683; 0,1 %, kariprazin: 22/2048; 1,1 %).
English: Reagila contains the active substance cariprazine and belongs to a group of medicines called antipsychotics.
Slovenian: Zdravilo Reagila vsebuje učinkovino kariprazin in sodi v skupino zdravil, imenovanih antipsihotiki.
English: Table 2 Summary of results in study RGH-188-005
Slovenian: Povzetek rezultatov študije RGH-188-005R Parametri učinkovitosti
English: Contact your doctor for advice.
Slovenian: Za nasvet se obrnite na zdravnika.
English: If you have serious kidney or liver problems Reagila may not be appropriate for you.
Slovenian: Če imate resne težave z ledvicami ali jetri, morda zdravilo Reagila ni primerno za vas.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX15
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Psiholeptiki, drugi antipsihotiki, oznaka ATC: N05AX15
English: It is unknown whether cariprazine or its major active metabolites are excreted in human milk.
Slovenian: Ni znano, ali se kariprazin ali njegovi glavni aktivni presnovki izločajo v materino mleko.
English: 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).
Slovenian: 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).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cariprazine in paediatric population.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Reagila za pediatrično populacijo.
English: Holter monitor-derived electrocardiographic assessments were obtained in 129 patients over a twelve hour period at baseline and steady state.
Slovenian: Ocene, izpeljane iz Holter-elektrokardiografije, so pridobili pri 129 bolnikih v obdobju dvanajst ur ob izhodišču in v stanju ravnovesja.
English: It should be considered that plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week (see section 5.2).
Slovenian: Upoštevati je treba, da se koncentracije kariprazina in njegovih aktivnih presnovkov v plazmi zmanjšajo za 50 % v ~1 tednu (glejte poglavje 5.2).
English: 95%CI
Slovenian: (95-% IZ)
English: 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.
Slovenian: 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.
English: Other medicines and Reagila
Slovenian: Druga zdravila in zdravilo Reagila
English: Efficacy with short-term use
Slovenian: Učinkovitost pri kratkotrajni uporabi
English: If signs and symptoms of tardive dyskinesia appear in a patient treated with cariprazine, discontinuation should be considered.
Slovenian: Če se znaki in simptomi tardivne diskinezije pojavijo pri bolnikih, zdravljenih s kariprazinom, je treba razmisliti o prekinitvi uporabe.
English: Cariprazine can cause orthostatic hypotension as well as hypertension (see section 4.8).
Slovenian: Kariprazin lahko povzroči ortostatsko hipotenzijo kot tudi hipertenzijo (glejte poglavje 4.8).
English: 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.
Slovenian: V stanju ravnovesja je izpostavljenost DDCAR približno dva- do trikrat večja kot izpostavljenost kariprazinu, izpostavljenost DCAR pa je približno 30 % izpostavljenosti kariprazinu.
English: (Side effect with frequency not known) - thoughts or feelings about hurting yourself or to commit suicide, suicide attempt.
Slovenian: (Neželeni učink z neznano pogostnostjo) - misli ali občutki o tem, da bi se poškodovali ali storili samomor, poskus samomora.
English: Reagila is for oral use, to be taken once daily at the same time of the day with or without food.
Slovenian: Način uporabe Zdravilo Reagila se uporablja peroralno in jemlje enkrat na dan ob istem času dneva s hrano ali brez nje.
English: - 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.
Slovenian: - 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)
English: 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.
Slovenian: 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.
English: If prescribed to patients with Parkinson's disease, antipsychotic medicinal products may exacerbate the underlying disease and worsen symptoms of Parkinson's disease.
Slovenian: Antipsihotična zdravila, predpisana bolnikom s Parkinsonovo boleznijo, lahko poslabšajo osnovno bolezen in simptome Parkinsonove bolezni.
English: 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.
Slovenian: 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.
English: Reagila is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Slovenian: Uporaba zdravila Reagila ni priporočljiva pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Since cariprazine is highly bound to plasma proteins, haemodialysis is unlikely to be useful in the management of overdose.
Slovenian: Ker se kariprazin v veliki meri veže na plazemske beljakovine, ni verjetno, da bi bila hemodializa v pomoč pri obravnavanju prevelikega odmerjanja.
English: Efficacy with long-term use
Slovenian: Učinkovitost pri dolgotrajni uporabi
English: 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.
Slovenian: 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.
English: Drowsiness, dizziness and vision problems may occur during treatment with this medicine (see section 4).
Slovenian: Med zdravljenjem s tem zdravilom se lahko pojavijo zaspanost, omotičnost in težave z vidom (glejte poglavje 4).
English: Elevated liver transaminases
Slovenian: Zvišane vrednosti jetrnih transaminaz
English: 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).
Slovenian: 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).
English: Prevention includes slow up-titration; treatment measures include slight down-titration of cariprazine or anti-EPS medication.
Slovenian: Preprečevanje vključuje počasno povečevanje odmerka; ukrepi zdravljenja vključujejo blago zmanjšanje odmerka kariprazina ali uvedba zdravila proti EPS.
English: Physicians should, therefore, weigh the risks versus the benefits when prescribing cariprazine to patients with Parkinson's disease.
Slovenian: Zdravnik mora pretehtati tveganja in koristi predpisovanja kariprazina bolnikom s Parkinsonovo boleznijo.
English: Your doctor will also inform you how to act if you switch from Reagila to another medicine.
Slovenian: Zdravnik vas bo obvestil tudi o tem, kako ravnati pri prehodu z zdravila Reagila na drugo zdravilo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: There is a minor or moderate risk that the medicine could affect the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Obstaja majhno ali zmerno tveganje, da bi lahko to zdravilo vplivalo na sposobnost vožnje in upravljanja strojev.
English: The metabolites of HCAR, HDCAR, and HDDCAR are subsequently biotransformed to their corresponding sulfate and glucuronide conjugates.
Slovenian: Presnovki HCAR, HDCAR in HDDCAR se nato biotransformirajo v svoje odgovarjajoče sulfatne in glukuronidne konjugate.
English: QR code to be included www.reagila.com
Slovenian: Vključiti kodo QR www.reagila.com
English: 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.
Slovenian: 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.
English: (Rare side effect) - symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Slovenian: (Redek neželeni učinek) - simptomi, povezani s krvnimi strdki v žilah, zlasti v nogah (simptomi vključujejo oteklost, bolečino in pordelost nog), ki lahko potujejo po krvnih žilah v pljuča, kjer povzročijo bolečino v prsih in težave z dihanjem.
English: The blisters are packed in a folded carton box.
Slovenian: Pretisni omoti so pakirani v škatlo.
English: The efficacy of cariprazine for maintaining antipsychotic effect was investigated in a randomizedwithdrawal, long-term clinical study.
Slovenian: Učinkovitost kariprazina pri vzdrževanju antipsihotičnega učinka so preučili v dolgoročni klinični študiji z randomizirano odtegnitvijo.
English: Nevertheless, patients who would develop symptoms potentially related to cataract should be advised to ophthalmologic examination and re-evaluated for treatment continuation.
Slovenian: Ne glede na to je treba bolnikom, pri katerih se razvijejo simptomi, ki so morebiti povezani s katarakto, svetovati pregled pri oftalmologu in jih pred nadaljevanjem zdravljenja ponovno oceniti.
English: The efficacy of cariprazine for the treatment of acute schizophrenia was studied in three multi-center, multinational, randomized, double-blind, placebo-controlled 6-week trials including 1,754 patients with the age of 18 to 60 years.
Slovenian: Učinkovitost kariprazina za zdravljenje akutne shizofrenije so preučili v treh multicentričnih, mednarodnih, randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih, v katera je bilo vključenih 1.754 bolnikov, starih od 18 do 60 let.
English: Patients should have their weight monitored regularly (see section 4.8).
Slovenian: Pri bolnikih je treba redno spremljati telesno maso (glejte poglavje 4.8).
English: After discontinuation of cariprazine treatment contraception should be used for at least 10 weeks due to the slow elimination of active moieties.
Slovenian: Po prekinitvi zdravljenja s kariprazinom je treba kontracepcijo uporabljati še vsaj 10 tednov zaradi počasnega izločanja aktivnih sestavin.
English: Do not breast-feed if you are taking Reagila because a risk for the baby cannot be excluded.
Slovenian: Med jemanjem zdravila Reagila ne smete dojiti, saj tveganja za dojenčka ni možno izključiti.
English: Ask your doctor about appropriate choices of contraception.
Slovenian: O ustrezni izbiri kontracepcije se posvetujte z zdravnikom.
English: No significant relationship was found between cariprazine plasma clearance and creatinine clearance.
Slovenian: Pomembnega razmerja med plazemskim očistkom kariprazina in očistkom kreatinina niso ugotovili.
English: No QT interval prolongation was detected following supratherapeutic doses (9 mg/day or 18 mg/day).
Slovenian: Podaljšanja intervala QT po supraterapevtskih odmerkih (9 mg/dan ali 18 mg/dan) niso opazili.
English: The effects of cariprazine on the QT interval were evaluated in patients with schizophrenia or schizoaffective disorder.
Slovenian: Učinke kariprazina na interval QT so ocenili pri bolnikih s shizofrenijo ali shizoafektivno motnjo.
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered.
Slovenian: V primeru resnih ekstrapiramidnih simptomov je treba dati antiholinergična zdravila.
English: In the population PK analysis there were no clinically relevant differences in the PK parameters (AUC and Cmax of the sum of cariprazine and its major active metabolites) based on age, gender and race.
Slovenian: V analizi populacijske farmakokinetike ni bilo klinično pomembnih razlik v farmakokinetičnih parametrih (AUC in Cmax vsote kariprazina in njegovih glavnih aktivnih presnovkov) na podlagi starosti, spola in etnične pripadnosti.
English: However, a causal relationship between lenticular changes / cataracts observed in human studies and cariprazine use has not been established.
Slovenian: Vendar pa vzročne povezanosti med spremembami leče/katarakto, ki so jo opazili v študijah pri ljudeh, in uporabo kariprazina niso dokazali.
English: As cariprazine causes akathisia and restlessness, it should be used cautiously in patients who are prone to or already exhibit symptoms of akathisia.
Slovenian: Ker kariprazin povzroči akatizijo in nemir, ga je treba pri bolnikih, ki so nagnjeni k simptomom akatizije ali jih že kažejo, uporabljati previdno.
English: There are no or limited amount of data from the use of cariprazine in pregnant women.
Slovenian: Podatkov o uporabi kariprazina pri nosečnicah ni oziroma so omejeni.
English: What Reagila is and what it is used for What you need to know before you take Reagila How to take Reagila
Slovenian: Kaj je zdravilo Reagila in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Reagila Kako jemati zdravilo Reagila Možni neželeni učinki
English: Therefore CYP2D6 inhibitors are unlikely to have a clinically relevant effect on cariprazine metabolism.
Slovenian: Zato ni verjetno, da bi zaviralci CYP2D6 imeli klinično pomemben učinek na presnovo kariprazina.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Možen vpliv drugih zdravil na kariprazin
English: What you need to know before you take Reagila
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Reagila
English: These are medicines used to treat heart diseases containing digoxin, blood thinners containing dabigatran, or medicines affecting your mental functions.
Slovenian: Med temi so zdravila, ki se uporabljajo za zdravljenje bolezni srca in vsebujejo digoksin, sredstvo za redčenje krvi, ki vsebuje dabigatran, ali zdravila, ki vplivajo na duševne sposobnosti.
English: - ever experienced or start to experience abnormal, involuntary movements, most commonly of the tongue or face.
Slovenian: - ste kadar koli imeli ali začenjate opažati nenormalne, nehotne gibe, najpogosteje jezika ali obraza.
English: Cariprazine has low affinity for serotonin 5-HT2C and adrenergic α1 receptors (Ki values of 134 nM and 155 nM, respectively).
Slovenian: Kariprazin ima nizko afiniteto za serotoninske receptorje 5HT2C in adrenergične receptorje α1 (vrednosti Ki 134 nM in 155 nM).
English: In the long term maintenance of effect study, there was no clinically relevant difference in change of body weight from baseline to end of treatment (1.1 kg for cariprazine and 0.9 kg for placebo).
Slovenian: V dolgoročni študiji vzdrževanja učinkovitosti ni bilo klinično pomembnih razlik v spremembi telesne mase od izhodišča do konca zdravljenja (1,1 kg za kariprazin in 0,9 kg za placebo).
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »Uporabno« do in »EXP«.
English: Cariprazine has two pharmacologically active metabolites with similar activites as cariprazine, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR).
Slovenian: Kariprazin ima dva farmakološko aktivna presnovka s podobno aktivnostjo kot kariprazin, desmetil kariprazin (DCAR) in didesmetil kariprazin (DDCAR).