natgillin/translations-raw huggingface dataset:
The data presented in this paragraph are based on a population pharmacokinetic analysis.
Podatki, navedeni v tem odstavku, izhajajo iz populacijske farmakokinetične analize.
Use the recommended re-initiation regimen shown in the table below.
Odmerjajte po priporočeni shemi ponovne uvedbe, ki je prikazana v preglednici spodaj.
> 3½ months up to 4 months
> 3 mesece in pol do 4 mesece
The following terms and frequencies are applied: 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); and not known (cannot be estimated from the available data).
Pri navajanju pogostnosti so uporabljeni naslednji izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Immediate medical treatment may be needed.
Morda bo potrebna takojšnja zdravniška pomoč.
Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to TREVICTA is known.
Zato je treba bolnikom svetovati, naj ne vozijo ali upravljajo s stroji, dokler ne bodo poznali svoje individualne občutljivosti za zdravilo TREVICTA.
4 months to 9 months
4 mesece do 9 mesecev
Elderly Efficacy and safety in elderly > 65 years have not been established.
Starejši Učinkovitosti in varnosti pri bolnikih, starejših od 65 let, niso dokazali.
The safety and efficacy of TREVICTA in children and adolescents < 18 years of age have not been established.
Varnost in učinkovitost zdravila TREVICTA pri otrocih in mladostnikih, starih < 18 let, nista bili dokazani.
The release of the active substance starts as early as day 1 and lasts for as long as 18 months.
Sproščanje zdravilne učinkovine se začne že 1. dan in traja tudi do 18 mesecev.
None of these events were serious or led to discontinuation.
Nobeden od teh dogodkov ni bil resen in zaradi nobenega ni bilo treba prekiniti zdravljenja.
The median time to relapse in either group could not be estimated due to low percentage of subjects with relapse.
Mediane časa do relapsa ni bilo mogoče oceniti v nobeni od skupin zaradi nizkega odstotka preiskovancev z relapsom.
The efficacy results were consistent across population subgroups (gender, age, and race) in both studies.
Rezultati glede učinkovitosti so bili v vseh podskupinah študijske populacije (po spolu, starosti in rasni pripadnosti) približno enaki v obeh študijah.
TREVICTA with alcohol Alcohol should be avoided.
Zdravilo TREVICTA skupaj z alkoholom Uživanju alkohola se je treba izogibati.
Week 19 to Week 24, inclusive
teden 12 do vključno teden 19 do vključno od tedna 25 naprej
Last TREVICTA dose (Week 0)
Zadnji odmerek zdravila TREVICTA (teden 0)
Do not use TREVICTA - if you are allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila TREVICTA - če ste alergični na paliperidon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If the patient remains symptomatic, they should be managed according to clinical practice.
Če simptomi pri bolniku vztrajajo, jih je treba obvladovati v skladu s klinično prakso.
Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 4 hours.
Bolnike je treba poučiti, da poiščejo nujno zdravniško pomoč, če priapizem ne izzveni v 4 urah.
Read complete instructions prior to use.
Pred uporabo preberite navodila v celoti.
The study was terminated on the basis of a pre-planned interim analysis conducted when 283 subjects had been randomised and 42 relapse events had been observed.
Študija je bila prekinjena na osnovi vnaprej načrtovane vmesne analize, po randomizaciji 283 preiskovancev in po 42 relapsih.
If patient weighs: Less than 90 kg pink hub
Če je bolnikova telesna masa: manj kot 90 kg rožnati nastavek
The suspension should appear uniform and milky white in colour.
Suspenzija mora biti enotna in mlečno bele barve.
> 9 months
> 9 mesecev
Four metabolic pathways have been identified in vivo, none of which accounted for more than 10% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
In vivo so odkrili štiri presnovne poti, od katerih nobena ni predstavljala več kot 10% odmerka: dealkilacija, hidroksilacija, dehidrogenacija in cepitev benzizoksazola.
DO NOT divide dose into multiple injections.
Odmerka NE SMETE razdeliti na več injekcij.
Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Takoj je treba začeti s spremljanjem srca in ožilja, ki mora vključevati neprekinjeno elektrokardiografsko spremljanje zaradi morebitnih aritmij.
There was a significant difference (p < 0.0001) between the two treatment groups in the time to relapse in favour of TREVICTA.
Med skupinama je bila tudi pomembna razlika (p < 0,0001) v času do relapsa in sicer v prid zdravilu TREVICTA.
Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Pri tistih, ki so jih zdravili z risperidonom, je bila smrtnost 4% v primerjavi s 3,1% pri placebu.
No in vivo data are available and the clinical relevance is unknown.
Podatki raziskav in vivo niso na voljo in klinični pomen teh ugotovitev ni znan.
The European Medicines Agency has waived the obligation to submit the results of studies with TREVICTA in all subsets of the paediatric population in schizophrenia.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom TREVICTA za vse podskupine pediatrične populacije s shizofrenijo.
Proceed to the next step immediately after shaking.
Takoj po stresanju nadaljujte z naslednjim korakom.
No interaction study between TREVICTA and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur.
Študij medsebojnega delovanja zdravila TREVICTA in litija niso izvedli, vendar ni verjetno, da bo prišlo do farmakokinetične interakcije.
TREVICTA should not be used during pregnancy unless clearly necessary.
Zdravilo TREVICTA se med nosečnostjo ne sme uporabljati, razen če je to nujno potrebno.
What you need to know before you use TREVICTA
Kaj morate vedeti, preden boste uporabili zdravilo TREVICTA
What TREVICTA is and what it is used for
Kaj je zdravilo TREVICTA in za kaj ga uporabljamo
For both studies, the primary outcome was based on relapse.
V obeh študijah je bil primarni cilj opazovanja relaps.
Figure 1: Kaplan-Meier plot of time to relapse - Final analysis
Slika 1: Kaplan-Meierjeva krivulja časa do relapsa - končna analiza
Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep.
Zelo pogosti neželeni učinki: pojavijo se lahko pri več kot 1 od 10 bolnikov • težave z uspavanjem ali vzdrževanjem spanca.
This medicine may cause an electrocardiogram (ECG) abnormality demonstrating a long time for an electrical impulse to travel through a certain part of the heart (known as “QT prolongation”).
To zdravilo lahko povzroči nepravilnost na elektrokardiogramu (EKG), ki se kaže kot podaljšano potovanje impulza skozi določen del srca (imenovano tudi »podaljšanje intervala QT«).
TREVICTA can help alleviate the symptoms of your disease and reduce the chance of your symptoms coming back.
Zdravilo TREVICTA pomaga lajšati simptome vaše bolezni in preprečuje, da bi se ponovno pojavili.
• loss of menstrual periods, leakage of milk from the breasts
• izguba menstruacije, iztekanje mleka iz dojk
Improvements in functioning, as measured by the Personal and Social Performance scale (PSP), which was observed during the open-label stabilisation phase were maintained during the double-blind phase for both treatment groups.
Izboljšanje funkcioniranja preiskovancev, ocenjeno z lestvico osebne in socialne učinkovitosti (Personal and Social Performance Scale, PSP), ki so ga opažali v fazi stabilizacije z odprtim zdravljenjem, se je v obdobju dvojno slepega zdravljenja ohranilo pri preiskovancih v obeh študijskih skupinah.
This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
To zmanjšanje je v veliki meri povzročeno s 35% povečanjem ledvičnega očistka paliperidona, verjetno zaradi indukcije ledvičnega P-gp s karbamazepinom.
(See Information intended for medical or health care professionals).
(Glejte Informacije za zdravnike in drugo zdravstveno osebje.)
In this period, 305 symptomatically stable subjects were randomised to continue treatment with TREVICTA (n = 160) or placebo (n = 145) until relapse, early withdrawal, or the end of study.
V tem obdobju je bilo 305 simptomatsko stabilnih preiskovancev randomiziranih tako, da so nadaljevali zdravljenje z zdravilom TREVICTA (n = 160) ali s placebom (n = 145) do relapsa, predčasne prekinitve ali do zaključka preskušanja.
Safety data involving concomitant use of TREVICTA with other antipsychotics is limited.
Podatki o varnosti sočasne uporabe zdravila TREVICTA in drugih antipsihotikov so omejeni.
• serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
• resna alergijska reakcija z otekanjem, ki lahko zajame grlo in povzroči težave z dihanjem
TREVICTA contains a racemic mixture of (+)- and (-)-paliperidone.
Zdravilo TREVICTA vsebuje racemat (+) in (-) paliperidona.
Taking this medicine with carbamazepine (an anti-epileptic and mood stabiliser) may require a change to your dose of this medicine.
Zaradi sočasnega jemanje tega zdravila s karbamazepinom (ki je zdravilo proti epilepsiji in stabilizator razpoloženja) bo morda treba prilagoditi odmerjanje tega zdravila.
Refer to ‘Hyperprolactinaemia' below.
Glejte “hiperprolaktinemija” spodaj.
Concomitant use of TREVICTA with psychostimulants
Sočasna uporaba zdravila TREVICTA in psihostimulansov
Based on the investigators' ratings, induration, redness, and swelling were absent or mild in ≥ 95% of the assessments.
Po oceni raziskovalcev so bile induracija, rdečina in oteklina blago izražene ali odsotne v ≥ 95%.
After shaking the syringe for at least 15 seconds, check the appearance of the suspension in the viewing window.
Po stresanju, ki naj traja najmanj 15 sekund, preverite izgled suspenzije v preglednem okencu.
You should not stop using this medicine unless told to do so by your doctor.
Uporabe tega zdravila ne smete prekiniti, razen če vam je to naročil zdravnik.
• low blood pressure, low blood pressure upon standing (consequently, some people taking this medicine may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
• nizek krvni tlak, nizek krvni tlak, ko vstanete (zato lahko nekateri ljudje, ki prejemajo to zdravilo, občutijo omedlevico, omotico ali pa se ob hitrem vstajanju ali vsedanju iz ležečega položaja zgrudijo)
Physicians should weigh the risks versus the benefits when prescribing TREVICTA to patients with Parkinson's disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotics.
Zdravnik mora pretehtati tveganja in koristi predpisovanja zdravila TREVICTA bolnikom s Parkinsonovo boleznijo ali z demenco z Lewyjevimi telesci, ker imata obe skupini lahko povečano tveganje za pojav nevroleptičnega malignega sindroma in tudi povečano občutljivost na antipsihotike.
The time to relapse of the placebo group (median 395 days) was significantly shorter than for the TREVICTA group (the median could not be estimated due to the low percentage of subjects with relapse [8.8%]).
Čas do relapsa je bil pomembno krajši v skupini s placebom (mediano 395 dni) v primerjavi s skupino, ki je prejemala zdravilo TREVICTA (mediane časa do relapsa ni bilo mogoče oceniti zaradi nizkega odstotka preiskovancev z relapsom [8,8%]).
Information intended for medical or health care professionals
Informacije za zdravnike in drugo zdravstveno osebje
In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
Študije in vitro na človeških jetrnih mikrosomih so pokazale, da paliperidon bistveno ne zavira presnove zdravil, ki se presnavljajo z izoencimi citokroma P450, vključno s CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4 in CYP3A5.
The needle is secure when a “click” sound is heard.
Injekcijska igla je ustrezno zaščitena, ko zaslišite »klik«.
C-paliperidone, 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised in the liver.
C-paliperidona s takojšnjim sproščanjem se je 59% odmerka izločilo nespremenjenega z urinom, kar kaže, da se paliperidon v jetrih ne presnavlja v veliki meri.
Elimination of paliperidone decreased with decreasing estimated creatinine clearance.
Izločanje paliperidona se je zmanjševalo skladnoz oceno zmanjševanja očistka kreatinina.
• white blood cell count decreased, decrease in the type of white blood cells that help to protect you against infection, decrease in platelets (blood cells that help you stop bleeding), anaemia
• zmanjšano število belih krvnih celic, zmanjšano število vrste belih krvnih celic, ki vas pomagajo varovati pred okužbami, zmanjšano število trombocitov (krvnih ploščic, ki omogočajo ustavljanje krvavitve), slabokrvnost (anemija)
Even though paliperidone is a strong D2-antagonist, which is believed to relieve the symptoms of schizophrenia, it causes less catalepsy and decreases motor functions less than traditional neuroleptics.
Čeprav je paliperidon močan antagonist D2 in menijo, da tako ublaži pozitivne simptome shizofrenije, v primerjavi s klasičnimi nevroleptiki povzroči manj katalepsije in manj oslabi motorično funkcijo.
Following administration of TREVICTA, the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.7-1.8.
Po odmerjanju zdravila TREVICTA se (+) in (-) enantiomer paliperidona pretvarjata eden v drugega tako, da je razmerje AUC med (+) in (-) enantiomerom približno 1,7 do 1,8.
A population pharmacokinetic analysis based on data with oral paliperidone prolonged release tablets showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Analiza farmakokinetike populacije podatkov na osnovi peroralnega paliperidona v obliki tablet s podaljšanim sproščanjem je pokazala nekoliko manjšo izpostavljenost paliperidonu pri kadilcih kot pri nekadilcih.
If you have responded well to treatment with paliperidone palmitate injection given once a month, your doctor may start treatment with TREVICTA.
Če ste se dobro odzvali na zdravljenje z injekcijami paliperidonijevega palmitata, ki ste jih prejemali enkrat na mesec, vas bo zdravnik lahko začel zdraviti z zdravilom TREVICTA.
In general, recommended dosing of TREVICTA for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Priporočeno odmerjanje zdravila TREVICTA pri starejših bolnikih z normalnim delovanjem ledvic je enako kot pri mlajših odraslih bolnikih z normalnim delovanjem ledvic.
• atrial fibrillation (an abnormal heart rhythm), irregular heart beat
• atrijska fibrilacija (motnja srčnega ritma), nepravilen srčni utrip
Negative means a lack of behaviours or feelings that are normally present.
Negativni simptomi odražajo pomanjkanje normalnih občutkov ali vedenja.
• are a man and experience prolonged or painful erection.
• ste moški in se pri vas pojavi dolgotrajna ali boleča erekcija, ki se imenuje priapizem.
However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death (see section 4).
Pri starejših bolnikih z demenco, ki se zdravijo s podobnimi zdravili, pa je tveganje za možgansko kap in smrt lahko povečano (glejte poglavje 4).
While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
Čeprav lahko distonija vključuje katerikoli del telesa (lahko povzroči nenormalno telesno držo), se pogosto pojavi na mišicah obraza, vključno z nenormalnimi gibi očesa, ust, jezika ali čeljusti.
The hazard ratio was 3.81 (95% CI: 2.08, 6.99) indicating a 74% decrease in relapse risk with TREVICTA compared to placebo.
Razmerje ogroženosti 3,81 (95% IZ: 2,08, 6,99) nakazuje, da je bilo pri uporabi zdravila TREVICTA tveganje za relaps zmanjšano za 74% v primerjavi s tveganjem pri uporabi placeba.
Refer to ‘Extrapyramidal symptoms' below.
Glejte “ekstrapiramidni simptomi” spodaj.
The release profile and dosing regimen of TREVICTA results in sustained therapeutic concentrations.
Profil sproščanja in režim odmerjanja zdravila TREVICTA omogočata dolgotrajno ohranjanje terapevtskih koncentracij.
• swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs
• otekanje obraza, ust, oči ali ustnic, otekline po telesu, rokah ali nogah
Following a single intramuscular dose of TREVICTA, the plasma concentrations of paliperidone gradually rise to reach maximum plasma concentrations at a median Tmax of 30-33 days.
Po intramuskularnem injiciranju enkratnih odmerkov zdravila TREVICTA se koncentracija paliperidona v plazmi postopoma povišuje in doseže najvišjo koncentracijo v plazmi v medianem času Tmax 30-33 dni.
The plasma protein binding of racemic paliperidone is 74%.
Vezava racemnega paliperidona na plazemske beljakovine je 74%.
Inject slowly, deep into the muscle taking care to avoid injection into a blood vessel.
Zdravilo injicirajte počasi, globoko v mišico in pazite, da ga ne injicirate v krvno žilo.
Full instructions for use and handling of TREVICTA are provided in the package leaflet (See Information intended for medical or health care professionals).
Natančna navodila za uporabo in ravnanje z zdravilom TREVICTA so v navodilu za uporabo (glejte Informacije za zdravnike in drugo zdravstveno osebje).
12 mg * All doses of once daily paliperidone prolonged release tablets should be individualised to the specific patient, taking into consideration variables such as reasons for switching, response to previous paliperidone treatment, severity of psychotic symptoms, and/or propensity for side effects.
12 mg * Odmerjanje tablet paliperidona s podaljšanim sproščanjem enkrat na dan je treba prilagoditi posameznemu bolniku in upoštevati dejavnike, kot so razlogi za zamenjavo, odziv na predhodno zdravljenje s paliperidonom, izraženost psihotičnih simptomov in/ali dovzetnost za neželene učinke.
Other medicines and TREVICTA Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Recommended re-initiation regimen after missing 4 months to 9 months of TREVICTA
Priporočena shema ponovne uvedbe zdravljenja po 4 do 9 mesecih izpuščanja odmerkov zdravila TREVICTA
It is also normal to see small air bubbles.
Če opazite majhne zračne mehurčke, je to povsem normalno.
Since no effect on the systemic clearance was observed, a clinically significant interaction would not be expected between divalproex sodium prolonged release tablets and TREVICTA intramuscular injection.
Ker niso opazili nobenega učinka na sistemski očistek, ne pričakujejo klinično pomembne interakcije med tabletami natrijevega divalproeksa s podaljšanim sproščanjem in intramuskularno injiciranim zdravilom TREVICTA.
However, in the event of an incompletely injected dose, the dose remaining in the syringe should not be re-injected and another dose should not be given since it is difficult to estimate the proportion of the dose actually administered.
Če odmerek ni bil injiciran v celoti, bolniku naknadno ne smemo injicirati preostanka vsebine v injekcijski brizgi ali novega odmerka, saj je težko oceniti, kolikšen del odmerka je bolnik dejansko prejel.
The patient should be closely monitored and managed as clinically appropriate until the next scheduled 3-monthly injection of TREVICTA.
Bolnika je treba skrbno spremljati in zdraviti v skladu s kliničnimi potrebami do naslednjega rednega odmerka 3-mesečne injekcije zdravila TREVICTA.
TREVICTA should be administered by a healthcare professional as a single injection.
Zdravilo TREVICTA smejo zdravstveni delavci aplicirati samo kot enkratno injekcijo.
If you stop receiving your injections, your symptoms of schizophrenia may get worse.
Če ste prenehali uporabljati zdravilo TREVICTA Če prenehate prejemati injekcije, se lahko simptomi shizofrenije poslabšajo.
Thin wall safety needles are designed specifically for use with TREVICTA.
Varnostne igle s tanko steno so oblikovane posebej za uporabo z zdravilom TREVICTA.
TREVICTA is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min).
Uporaba zdravila TREVICTA ni priporočljiva pri bolnikih z zmerno ali hudo okvaro ledvic (z očistkom kreatinina < 50 ml/min).
• increase in eosinophils (a type of white blood cell) in your blood
• povečano število eozinofilcev (vrsta belih krvnih celic) v krvi
Prepare for injection
Priprava na injiciranje
What TREVICTA is and what it is used for What you need to know before you use TREVICTA How to use TREVICTA
Kaj je zdravilo TREVICTA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo TREVICTA Kako uporabljati zdravilo TREVICTA Možni neželeni učinki
The following information is intended for medical or healthcare professionals only and should be read by the medical or healthcare professional in conjunction with the full prescribing information (Summary of Product Characteristics).
Zdravniki in drugi zdravstveni delavci naj te informacije preberejo skupaj z informacijami za predpisovanje (povzetek glavnih značilnosti zdravila).
• TREVICTA can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
• Zdravilo TREVICTA lahko v krvnih preiskavah poviša koncentracije hormona, ki ga imenujemo ''prolaktin'' (kar lahko povzroči simptome ali pa ne).
TREVICTA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Pri sočasni uporabi zdravila TREVICTA z zdravili, ki povečajo aktivnost centralnega živčnega sistema (psihostimulansi, kot je metilfenidat), je potrebna previdnost.
Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Na podlagi študij in vitro, v katerih so uporabili humane jetrne encime, paliperidon ni substrat za encim CYP1A2, zato kajenje ne bi smelo vplivati na farmakokinetiko paliperidona.