FrancophonIA/ELRC3.0 huggingface dataset:
English: Re-initiate treatment with 1-monthly paliperidone palmitate injectable as described in the prescribing information for that product.
Slovenian: Ponovno uvedite zdravljenje z 1-mesečno injekcijo paliperidonijevega palmitata, kot je opisano v povzetku glavnih značilnosti tega zdravila.
English: These tumours can be related to prolonged dopamine D2-antagonism and hyperprolactinemia.
Slovenian: Ti tumorji so lahko povezani s podaljšanim antagonističnim delovanjem na dopaminskih receptorjih D2 in hiperprolaktinemijo.
English: If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Slovenian: Če se pripravljate na operacijo očesa, morate o jemanju tega zdravila obvestiti okulista.
English: It should be administered into the upper-outer quadrant of the gluteal muscle.
Slovenian: Zdravilo je treba injicirati v zgornji zunanji kvadrant glutealne mišice.
English: In vitro studies indicate that CYP2D6 and CYP3A4 may be minimally involved in paliperidone metabolism, but there are no indications in vitro nor in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Slovenian: Študije in vitro kažejo, da sta encima CYP2D6 in CYP3A4 minimalno vključena v presnovo paliperidona, vendar ni in vitro ali in vivo znakov, da imata ta dva izoencima pomembno vlogo pri presnovi paliperidona.
English: QT prolongation, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest, and Torsade de pointes may occur with antipsychotics.
Slovenian: Pri uporabi antipsihotikov lahko pride do podaljšanja intervala QT, ventrikularnih aritmij (ventrikularne fibrilacije, ventrikularne tahikardije), nenadne nepojasnjene smrti, srčnega zastoja in pojava torsade de pointes.
English: NOTE: This medicine requires longer and more vigorous shaking than 1-monthly paliperidone palmitate injectable.
Slovenian: OPOZORILO: To zdravilo je treba stresati dlje in močneje kot 1-mesečno injekcijo paliperidonijevega palmitata.
English: Since this medicine works primarily in the brain, using other medicines that work in the brain can cause an exaggeration of side effects such as sleepiness or other effects on the brain such as other psychiatric medications, opioids, antihistamines and sleep medication.
Slovenian: To zdravilo deluje predvsem na možgane, zato uporaba drugih zdravil (kot so druga psihiatrična zdravila, opioidi, antihistaminiki in zdravila za spanje), ki tudi delujejo na možgane, lahko povzroči prekomerno izraženost neželenih učinkov, kot je zaspanost, ali druge učinke na možgane.
English: The mean changes in body weight from double-blind baseline to double-blind end point were +0.94 kg and -1.28 kg for the TREVICTA and placebo groups, respectively.
Slovenian: Povprečna sprememba telesne mase od izhodišča dvojno slepega zdravljenja do zaključka opazovanja dvojno slepega zdravljenja je bila +0,94 kg v skupini z zdravilom TREVICTA in -1,28 kg v skupini s placebom.
English: TREVICTA has not been studied in elderly patients with dementia.
Slovenian: Zdravila TREVICTA niso preučevali pri starejših bolnikih z demenco.
English: If you have mild kidney problems your doctor will determine the appropriate dose of TREVICTA based on the dose of 1-monthly paliperidone palmitate injectable that you have been receiving.
Slovenian: Če imate blago okvaro ledvic, bo zdravnik določil ustrezen odmerek zdravila TREVICTA glede na vaš zadnji odmerek 1-mesečne injekcije paliperidonijevega palmitata.
English: Inject
Slovenian: Injiciranje
English: In the long-term randomised withdrawal study, 506 adult subjects who met DSM-IV criteria for schizophrenia were enrolled into the open-label transition phase and treated with flexible doses of 1-monthly paliperidone palmitate injectable administered into the deltoid or gluteal muscle (50-150 mg) for 17 weeks (dose adjustments occurred at weeks 5 and 9).
Slovenian: V dolgotrajno randomizirano preskušanje odtegnitve zdravila so vključili 506 odraslih bolnikov, ki so izpolnjevali merila za shizofrenijo DSM-IV. Bolnike so najprej vključili v prehodno fazo z odprtim zdravljenjem, kjer so 17 tednov (odmerek so prilagajali v 5. in 9. tednu) prejemali fleksibilne odmerke 1-mesečnih injekcij paliperidonijevega palmitata v deltoidno ali glutealno mišico (50-150 mg).
English: If more than 5 minutes pass before injection, shake vigorously again for at least 15 seconds to re-suspend the medicinal product.
Slovenian: Če pred injiciranjem preteče več kot 5 minut, je treba zdravilo ponovno stresati najmanj 15 sekund, da se resuspendira.
English: The specified needle for administration of TREVICTA into the deltoid muscle is determined by the patient's weight.
Slovenian: Ustrezno iglo za injiciranje zdravila TREVICTA v deltoidno mišico določimo glede na bolnikovo telesno maso.
English: Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when TREVICTA is administered with other medicinal products that have this potential, e.g., other antipsychotics, tricyclics.
Slovenian: Zdravilo TREVICTA lahko povzroči ortostatsko hipotenzijo (glejte poglavje 4.4), zato je pri sočasni uporabi zdravila TREVICTA in drugih zdravil z enakim delovanjem, kot so drugi antipsihotiki in triciklični antidepresivi, mogoče opaziti aditivni učinek.
English: • neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness), blood vessel problems in the brain, including sudden loss of blood supply to brain (stroke or "mini" stroke), unresponsive to stimuli, loss of consciousness, low level of consciousness, convulsion (fits), balance disorder
Slovenian: • nevroleptični maligni sindrom (zmedenost, zmanjšana stopnja zavesti ali nezavest, visoka telesna temperatura in huda okorelost mišic), težave s krvnimi žilami v možganih, vključno z nenadno prekinitvijo prekrvavitve možganov (kap ali ''mini kap''), neodzivnost na dražljaje,
English: The needle to be used for administration of TREVICTA into the gluteal muscle is the thin wall 1½ inch, 22 gauge (0.72 mm x 38.1 mm) needle regardless of body weight.
Slovenian: Za injiciranje zdravila TREVICTA v glutealno mišico je treba uporabiti iglo s tanko steno, dolžine 1½ palca in velikosti 22G (0,72 mm x 38,1 mm) ne glede na bolnikovo telesno maso.
English: What TREVICTA contains
Slovenian: Kaj vsebuje zdravilo TREVICTA
English: With your other hand, hold the syringe by the luer connection and attach it to the safety needle with a gentle clockwise twisting motion.
Slovenian: Z drugo roko primite injekcijsko brizgo v bližini Luer nastavka in nanjo pričvrstite varnostno iglo z nežnim zasukom v smeri urinega kazalca.
English: Pack sizes: Pack contains 1 pre-filled syringe and 2 needles
Slovenian: Velikosti pakiranj: Eno pakiranje vsebuje 1 napolnjeno injekcijsko brizgo in 2 injekcijski igli.
English: Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another.
Slovenian: Paliperidon je aktivni presnovek risperidona, zato sta njuna profila neželenih učinkov (peroralne oblike in injekcij) povezana.
English: Then, holding the syringe upright, twist and pull the rubber cap to remove.
Slovenian: Nato z injekcijske brizge, ki jo držite obrnjeno z vrhom navzgor, odstranite gumijasto zaporko tako, da jo odvijete in potegnete.
English: This medicine will be given to you under medical supervision; it is, therefore, unlikely that you will be given too much.
Slovenian: Če ste uporabili večji odmerek zdravila TREVICTA, kot bi smeli To zdravilo boste prejemali pod zdravniškim nadzorom, zato je malo verjetno, da boste prejeli prevelik odmerek.
English: The following are all ADRs that were reported with paliperidone by frequency category estimated from paliperidone palmitate clinical trials.
Slovenian: V nadaljevanju so po pogostnosti navedeni vsi neželeni učinki, o katerih so poročali pri uporabi paliperidona v kliničnih preskušanjih paliperidonijevega palmitata.
English: TREVICTA must be administered using only the thin wall needles that are provided in the TREVICTA pack.
Slovenian: Za injiciranje zdravila TREVICTA je treba vedno uporabiti igle s tanko steno, ki so priložene pakiranju zdravila TREVICTA.
English: Insomnia includes: initial insomnia, middle insomnia; Convulsion includes: grand mal convulsion; Oedema includes: generalised oedema, oedema peripheral, pitting oedema Menstrual disorder includes: menstruation delayed, menstruation irregular, oligomenorrhoea.
Slovenian: Nespečnost vključuje: težave ob uspavanju, prebujanje ponoči; Konvulzije vključujejo: konvulzije tipa grand mal; Edem vključuje: generaliziran edem, periferni edem, testasti edem; Motnje menstruacije vključujejo; zapoznelo menstruacijo, neredne menstruacije, oligomenorejo.
English: SHAKE VIGOROUSLY for at least 15 seconds
Slovenian: Najmanj 15 sekund MOČNO STRESAJTE !
English: The exposure range for TREVICTA is encompassed within the exposure range for the approved dose strengths of paliperidone prolonged release tablets.
Slovenian: Razpon izpostavljenosti učinkovini pri odmerjanju zdravila TREVICTA je znotraj razpona izpostavljenosti odobrenih odmerkov paliperidona v obliki tablet s podaljšanim sproščanjem.
English: diabetes mellitus d, hyperinsulinaemia, increased appetite, anorexia, blood triglycerides increased, blood cholesterol increased diabetic ketoacidosis, hypoglycaemia, polydipsia water intoxication
Slovenian: hiperinsulinemija, povečan apetit, anoreksija, povišana koncentracija trigliceridov v krvi, povišana koncentracija holesterola v krvi diabetična ketoacidoza, hipoglikemija, polidipsija zastrupitev z vodo
English: Dispose of the syringe and unused needle in an approved sharps container.
Slovenian: Injekcijsko brizgo in neuporabljeno iglo zavrzite v posodo za odlaganje ostrih predmetov.
English: For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 mL/min), dose should be adjusted and the patient stabilised using 1-monthly paliperidone palmitate injectable, and then transitioned to TREVICTA.
Slovenian: Pri bolnikih z blago okvaro ledvic (očistek kreatinina ≥ 50 do < 80 ml/min) je treba odmerek prilagoditi in bolnike najprej stabilizirati z 1-mesečnimi injekcijami paliperidonijevega palmitata ter nato preiti na zdravilo TREVICTA.
English: In the non-inferiority study, 1,429 acutely ill subjects (baseline mean PANSS total score: 85.7) who met DSM-IV criteria for schizophrenia were enrolled into the open-label phase and treated with 1-monthly paliperidone palmitate injectable for 17 weeks.
Slovenian: V študijo za oceno neinferiornosti so vključili 1.429 preiskovancev z akutno shizofrenijo s povprečno izhodiščno oceno 85,7 na celotni lestvici pozitivnih in negativnih sindromov (Positive and Negative Syndrome Scale, PANSS), ki so izpolnjevali merila za shizofrenijo po DSM-IV. Preiskovance so najprej vključili v fazo odprtega zdravljenja in jih 17 tednov zdravili z 1-mesečnimi injekcijami paliperidonijevega palmitata.
English: For patients with mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min), dose should be adjusted and the patient stabilised using 1-monthly paliperidone palmitate injectable, then transitioned to TREVICTA.
Slovenian: Pri bolnikih z blago okvaro ledvic (z očistkom kreatinina ≥ 50 ml/min do < 80 ml/min) je treba odmerke prilagoditi in bolnike najprej stabilizirati z 1-mesečnimi injekcijami paliperidonijevega palmitata ter nato preiti na zdravilo TREVICTA.
English: C-paliperidone, one week following administration of a single oral dose of 1 mg immediate release
Slovenian: En teden po uporabi enkratnega peroralnega odmerka 1 mg
English: Immediately discard the unused needle in an approved sharps container.
Slovenian: Neuporabljeno iglo takoj odvrzite v posodo za odlaganje ostrih predmetov.
English: Antipsychotic medicinal products (including paliperidone) with alpha-adrenergic blocking effects have been reported to induce priapism.
Slovenian: Poročali so, da antipsihotiki z zaviralnim delovanjem na adrenergične receptorje alfa (vključno s paliperidonom) povzročajo priapizem.
English: • accumulation of pus caused by infection at injection site, deep skin infection, a cyst at the injection site, bruising at injection site.
Slovenian: • kopičenje gnoja zaradi okužbe na mestu injiciranja, globoka okužba kože, cista na mestu injiciranja, modrica na mestu injiciranja
English: • increased liver transaminases in your blood
Slovenian: • povišane koncentracije jetrnih aminotransferaz v krvi
English: Shake vigorously
Slovenian: močno pretresite
English: Do not use this medicine in children and adolescents under 18 years of age.
Slovenian: Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker ni znano, ali je uporaba pri teh bolnikih varna in učinkovita.
English: If more than 5 minutes pass before injection, shake vigorously, with the syringe tip pointing up, again for at least 15 seconds to re-suspend the medication.
Slovenian: Če zdravilo pred injiciranjem miruje več kot 5 minut, je treba injekcijsko brizgo z vrhom obrnjenim navzgor ponovno močno stresati najmanj 15 sekund, da se zdravilo resuspendira.
English: TREVICTA doses for patients adequately treated with 1-monthly paliperidone palmitate injectable If the last dose of 1-monthly paliperidone palmitate injectable is
Slovenian: Odmerki zdravila TREVICTA pri bolnikih, ki so ustrezno zdravljeni z 1-mesečnimi injekcijami paliperidonijevega palmitata Zadnji odmerek 1-mesečne injekcije paliperidonijevega palmitata
English: Overall incidence from all clinical trials was 0.65% in all subjects treated 1-monthly paliperidone palmitate injectable.
Slovenian: V kliničnih preskušanih je bila skupna pojavnost pri bolnikih, zdravljenih z 1-mesečno injekcijo paliperidonijevega palmitata 0,65%.
English: TREVICTA should be initiated in place of the next scheduled dose of 1-monthly paliperidone palmitate injectable (± 7 days).
Slovenian: Zdravilo TREVICTA uvedemo namesto 1-mesečnega paliperidonijevega palmitata ob naslednjem načrtovanem odmerku 1-mesečne injekcije (± 7 dni).
English: Conversely, abnormal decreases in body weight (≥ 7%) from double-blind baseline to double-blind end point were reported for 1% subjects in the TREVICTA group and 8% subjects in the placebo group.
Slovenian: O nenormalnem zmanjšanju telesne mase (za ≥ 7%) od začetka dvojno slepega zdravljenja do zaključka pa so poročali pri 1% preiskovancev v skupini z zdravilom TREVICTA in pri 8% preiskovancev v skupini s placebom.
English: • erectile dysfunction, ejaculation disorder, missed menstrual periods or other problems with your cycle (females), development of breasts in men, sexual dysfunction, breast pain
Slovenian: • težave pri doseganju ali vzdrževanju erekcije (erektilna disfunkcija), motnje ejakulacije, izostanek menstruacije ali druge težave z menstrualnim ciklusom (pri ženskah), nastanek dojk pri moških, motnje v spolnosti, bolečine v dojkah
English: Excipients: polysorbate 20, polyethylene glycol 4000, citric acid monohydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, water for injections
Slovenian: Pomožne snovi: polisorbat 20, polietilenglikol 4000, citronska kislina monohidrat, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid, voda za injekcije
English: Switching from TREVICTA to oral daily paliperidone prolonged release tablets For switching from TREVICTA to paliperidone prolonged release tablets, the daily dosing of paliperidone prolonged release tablets should be started 3 months after the last TREVICTA dose and treatment continued with paliperidone prolonged release tablets as described in the table below.
Slovenian: Pri prehodu z zdravila TREVICTA na tablete paliperidona s podaljšanim sproščanjem je treba dnevno odmerjanje tablet paliperidona s podaljšanim sproščanjem začeti 3 mesece po zadnjem odmerku zdravila TREVICTA, nato pa zdravljenje nadaljevati, kot je navedeno v spodnji preglednici.
English: Dosing TREVICTA should be administered once every 3 months.
Slovenian: Odmerjanje Zdravilo TREVICTA je treba odmerjati enkrat na 3 mesece.
English: Psychiatric disorders insomnia e agitation, depression, anxiety sleep disorder, mania, libido decreased, nervousness, nightmare catatonia, confusional state, somnambulism, blunted affect, anorgasmia sleep-related eating disorder
Slovenian: Psihiatrične motnje nespeč nost agitacija, depresija, tesnoba motnje spanja, manija, zmanjšan libido, nervoznost, nočne more katatonija, stanje zmedenosti, somnambulizem, čustvena otopelost, anorgazmija s spanjem povezane motnje hranjenja
English: Needle selection is determined by injection site and patient weight.
Slovenian: Pri izbiri igle upoštevajte mesto injiciranja in bolnikovo telesno maso.
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 TREVICTA and preventative measures undertaken.
Slovenian: Zato je pred in med zdravljenjem z zdravilom TREVICTA treba preveriti vse dejavnike tveganja za VTE in uvesti preventivne ukrepe.
English: Even if you have previously tolerated oral paliperidone or risperidone, rarely allergic reactions occur after receiving injections of TREVICTA.
Slovenian: Tudi če ste dobro prenašali peroralni paliperidon ali peroralni risperidon, se lahko po injiciranju zdravila TREVICTA redko pojavijo alergijske reakcije.
English: • dead skin cells at injection site, an ulcer at injection site.
Slovenian: • odmrle kožne celice na mestu injiciranja, razjede na mestu injiciranja
English: Uncommon side effects: may affect up to 1 in 100 people
Slovenian: Občasni neželeni učinki: pojavijo se lahko pri največ 1 od 100 bolnikov
English: Undesirable effects noted with risperidone formulations
Slovenian: Neželeni učinki, ki so jih opažali pri uporabi zdravil z risperidonom
English: TREVICTA 175 mg prolonged release suspension for injection TREVICTA 263 mg prolonged release suspension for injection TREVICTA 350 mg prolonged release suspension for injection TREVICTA 525 mg prolonged release suspension for injection
Slovenian: TREVICTA 175 mg suspenzija za injiciranje s podaljšanim sproščanjem TREVICTA 263 mg suspenzija za injiciranje s podaljšanim sproščanjem TREVICTA 350 mg suspenzija za injiciranje s podaljšanim sproščanjem TREVICTA 525 mg suspenzija za injiciranje s podaljšanim sproščanjem
English: The plasma concentrations of paliperidone are increased in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic so koncentracije paliperidona v plazmi povečane.
English: TREVICTA is designed to deliver paliperidone over a 3-month period, while 1-monthly paliperidone palmitate injection is administered on a monthly basis.
Slovenian: Zdravilo TREVICTA je zasnovano tako, da omogoča sproščanje paliperidona 3 mesece, medtem ko se 1-mesečne injekcije paliperidonijevega palmitata injicira enkrat na mesec.
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Slovenian: Poleg ekstrapiramidnih simptomov lahko znaki povečane občutljivosti vključujejo tudi zmedenost, otopelost in nestabilno držo s pogostimi padci.
English: Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with paliperidone.
Slovenian: Poročali so, da se pri uporabi paliperidona lahko pojavi nevroleptični maligni sindrom (NMS), za katerega so značilni hipertermija, mišična rigidnost, avtonomna nestabilnost, spremenjeno stanje zavesti in povečanje koncentracije kreatinin kinaze v serumu.
English: In the long-term randomised withdrawal study, abnormal increases of ≥ 7% in body weight from double-blind baseline to double-blind end point were reported for 10% subjects in the TREVICTA group and 1% subjects in the placebo group.
Slovenian: V dolgotrajnem randomiziranem preskušanju odtegnitve zdravila so od začetka do konca dvojno slepega zdravljenja poročali o nenormalnem povečanju telesne mase za ≥ 7%, in sicer pri 10% preiskovancev v skupini z zdravilom TREVICTA in pri 1% preiskovancev v skupini s placebom.
English: Shake the syringe vigorously, with the syringe tip pointing up, for at least 15 seconds within 5 minutes prior to administration (see Step 2).
Slovenian: Injekcijsko brizgo z vrhom obrnjenim navzgor 5 minut pred odmerjanjem najmanj 15 sekund močno stresajte (glejte korak št. 2).
English: Peel off the tab label from the syringe and place in patient record.
Slovenian: Z injekcijske brizge odstranite nalepko in jo prilepite v bolnikovo zdravstveno dokumentacijo.
English: TREVICTA should be injected once every 3 months.
Slovenian: Zdravilo TREVICTA se odmerja enkrat na 3 mesece.
English: The 1-monthly paliperidone palmitate injectable should then continue to be dosed at monthly intervals as described within its prescribing information.
Slovenian: Zdravljenje z 1-mesečnimi injekcijami paliperidonijevega palmitata je treba nato nadaljevati z enomesečnimi presledki, kot je navedeno v povzetku glavnih značilnosti zdravila.
English: Care must be taken to avoid inadvertent injection of TREVICTA into a blood vessel.
Slovenian: Injiciranje Pazimo, da zdravila TREVICTA pomotoma ne injiciramo v žilo.
English: Doses of 1-monthly paliperidone palmitate injectable for patients switching from TREVICTA If the last dose of TREVICTA is
Slovenian: Odmerki 1-mesečne injekcije paliperidonijevega palmitata pri bolnikih, ki so prešli z uporabe zdravila TREVICTA Zadnji odmerek zdravila TREVICTA
English: TREVICTA 175 mg prolonged release suspension for injection TREVICTA 263 mg prolonged release suspension for injection TREVICTA 350 mg prolonged release suspension for injection TREVICTA 525 mg prolonged release suspension for injection paliperidone
Slovenian: TREVICTA 175 mg suspenzija za injiciranje s podaljšanim sproščanjem TREVICTA 263 mg suspenzija za injiciranje s podaljšanim sproščanjem TREVICTA 350 mg suspenzija za injiciranje s podaljšanim sproščanjem TREVICTA 525 mg suspenzija za injiciranje s podaljšanim sproščanjem paliperidon
English: What TREVICTA looks like and contents of the pack TREVICTA is a white to off-white prolonged release suspension for injection in a pre-filled syringe that your doctor or nurse will shake vigorously to resuspend the suspension before it is given as an injection.
Slovenian: Izgled zdravila TREVICTA in vsebina pakiranja Zdravilo TREVICTA je bela do sivkastobela suspenzija za injiciranje s podaljšanim sproščanjem v napolnjeni injekcijski brizgi.
English: Population pharmacokinetics analysis showed no evidence of race related pharmacokinetics differences.
Slovenian: Analiza farmakokinetike populacije ni pokazala rasno pogojenih razlik v farmakokinetiki zdravila.
English: Caution is advised if paliperidone is combined with other medicinal products known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.).
Slovenian: Če se paliperidon uporablja sočasno z zdravili, ki znižajo prag za epileptične napade (kot so fenotiazini ali butirofenoni, triciklični antidepresivi ali selektivni zaviralci ponovnega privzema serotonina (SSRI), tramadol, meflokin itd.), je potrebna previdnost.
English: • diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels) in your blood
Slovenian: • sladkorna bolezen ali poslabšanje sladkorne bolezni, povišanje koncentracije insulina (hormona,