natgillin/translations-raw huggingface dataset:
91.6 (12.19) -15.0 (19.61) < 0.001 -11.6 (2.35)
Srednja sprememba (SD) P- vrednost (v primerjavi s placebom)
93.9 (13.20) -16.3 (21.81) < 0.001 -12.9 (2.34)
Razlika med srednjimi vrednostmi LS (SE)
Negative change in score indicates improvement.
Negativna sprememba ocene kaže na izboljšanje bolnikovega stanja.
The 1-7 version of the PANSS was used.
Uporabljali so PANS lestvico (verzije 1- 7).
A 15 mg dose was also included in Study R076477-SCH-305, but results are not presented since this is above the maximum recommended daily dose of 12 mg.
V študiji R076477- SCH - 305 so uporabili tudi 15 mg odmerek, vendar ti rezultati niso vključeni zgoraj, ker ta odmerek presega največji priporočeni dnevni odmerek 12 mg.
In a long-term trial designed to assess the maintenance of effect, INVEGA was significantly more effective than placebo in maintaining symptom control and delaying relapse of schizophrenia.
V dolgoročnem preskušanju za oceno ohranitve učinka zdravila INVEGA je bilo to zdravilo bistveno bolj učinkovito od placeba pri ohranjanju nadzora nad simptomi in pri zapoznitvi ponovnih izbruhov shizofrenije.
After having been treated for an acute episode for 6 weeks and stabilized for an additional 8 weeks with INVEGA (doses ranging from 3 to 15 mg once daily) patients were then randomised in a double-blind manner to either continue on INVEGA or on placebo until they experienced a relapse in schizophrenia
Po 6- tedenskem zdravljenju akutne epizode z zdravilom INVEGA (odmerki so bili v razponu od 3 do 15 mg enkrat na dan) in stabilizaciji stanja v dodatnih 8 tednih so bolnike randomizirali na dvojno slep način v dve skupini: ena je nadaljevala zdravljenje z zdravilom INVEGA, druga pa je jemala placebo, dokler se niso ponovili simptomi shizofrenije.
The trial was stopped early for efficacy reasons by showing a significantly longer time to relapse in patients treated with INVEGA compared to placebo (p=0.0053).
Preskušanje so ustavili predčasno zaradi učinkovitosti zdravila, saj je preskušanje pokazalo bistveno daljši čas do ponovnega izbruha bolezni pri bolnikih, zdravljenih z zdravilom INVEGA v primerjavi s placebom (p=0, 0053).
Absorption Following a single dose, INVEGA exhibits a gradual ascending release rate, allowing the plasma concentrations of paliperidone to steadily rise to reach peak plasma concentration (Cmax) approximately 24 hours after dosing.
11 Absorpcija Po zaužitju enkratnega odmerka zdravila INVEGA postopno narašča njegova hitrost sproščanja, zaradi česar se plazemske koncentracije paliperidona ves čas zvišujejo in dosežejo največjo plazemsko koncentracijo (Cmax) približno 24 ur po jemanju zdravila.
The absolute oral bioavailability of paliperidone following INVEGA administration is 28% (90% CI of 23%-33%).
Absolutna peroralna biološka uporabnost paliperidona po jemanju zdravila INVEGA znaša 28% (90% CI od 23% - 33%).
Administration of paliperidone prolonged-release tablets with a standard high-fat/ high-caloric meal increases Cmax and AUC of paliperidone by up to 50-60% compared with administration in the fasting state.
Pri zaužitju paliperidona v tableti s podaljšanim sproščanjem z običajnim mastnim oz. visokokaloričnim obrokom se vrednosti Cmax in AUC za paliperidon povečajo za do 50- 60% v primerjavi z zaužitjem zdravila na tešče.
Distribution Paliperidone is rapidly distributed.
Porazdelitev Paliperidon se hitro porazdeli po telesu.
It binds primarily to α 1-acid glycoprotein and albumin.
Na plazemske beljakovine se veže v 74%, in sicer predvsem na α1- kisli glikoprotein in na albumin.
Biotransformation and elimination One week following administration of a single oral dose of 1 mg immediate-release 14C-paliperidone, 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised by the liver.
Biotransformacija in izločanje En teden po zaužitju enkratnega peroralnega odmerka 1 mg radioaktivno označenega paliperidona- 14C s takojšnjim sproščanjem se je 59% odmerka izločilo v nespremenjeni obliki s sečem, kar pomeni, da v jetrih ne pride do obsežne presnove paliperidona.
Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
In vivo so sicer ugotovili štiri presnovne poti, vendar se po nobeni od njih ne presnovi več kot 6, 5% zaužitega odmerka: dealkilacija, hidroksilacija, dehidrogenacija in benzizoksazolska cepitev.
Population pharmacokinetics analyses indicated no discernable difference on the apparent clearance of paliperidone after administration of INVEGA between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Analize populacijske farmakokinetike niso pokazale nikakršnih vidnih razlik v navideznem očistku paliperidona po jemanju zdravila INVEGA med osebami z obsežno presnovo substratov CYP2D6 in tistimi, ki te substrate slabo presnavljajo.
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 mikrosomih človeških jeter pa so pokazale, da paliperidon bistveno ne zavira presnove zdravil, ki se presnavljajo z izoencimi citokroma P450, na primer s CYP1A2, CYP2A6, CYP2C8/ 9/ 10, CYP2D6, CYP2E1, CYP3A4 in CYP3A5.
In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
In vitro študije so pokazale, da je paliperidon substrat za P- glikoprotein (P- gp), in šibek zaviralec P- gp v visokih koncentracijah.
Hepatic Impairment Paliperidone is not extensively metabolized in the liver.
Jetrna okvara Paliperidon se v jetrih presnavlja le v manjši meri.
In a study in subjects with moderate hepatic impairment (Child-Pugh class B), the plasma concentrations of free paliperidone were similar to those of healthy subjects.
V študiji pri preiskovancih z zmerno jetrno okvaro (razreda B po Child- Pughu) so bile plazemske koncentracije prostega paliperidona podobne tistim pri zdravih preiskovancih.
No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Ni podatkov o bolnikih s hudo jetrno okvaro (razreda C po Child- Pughu).
11 Renal Impairment Elimination of paliperidone decreased with decreasing renal function.
Ledvična okvara Izločanje paliperidona se zmanjšuje z zmanjševanjem delovanja ledvic.
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [Cr Cl] = 50 to < 80 ml/ min), 64% in moderate (CrCl = 30 to < 50 ml/ min), and 71% in severe (CrCl = < 30 ml/ min) renal impairment.
Celotni očistek paliperidona je bil zmanjšan pri preiskovancih z motnjami delovanja ledvic, in sicer za 32% pri blagi ledvični okvari (očistek kreatinina [CrCl] =50 do < 80 ml/ min), za 64% pri zmerni ledvični okvari (CrCl = 30 do < 50 ml/ min) in za 71% pri hudi ledvični okvari (CrCl= < 30 ml/ min).
The mean terminal elimination half-life of paliperidone was 24, 40, and 51 hours in subjects with mild, moderate, and severe renal impairment, respectively, compared with 23 hours in subjects with normal renal function (CrCl ≥ 80 ml/ min).
Srednja končna razpolovna doba izločanja paliperidona je znašala 24 ur pri preiskovancih z blago ledvično okvaro, 40 ur pri preiskovancih z zmerno ledvično okvaro in 51 ur pri tistih s hudo ledvično okvaro, v primerjavi s 23 urami pri preiskovancih z normalnim delovanjem ledvic (CrCl ≥ 80 ml/ min).
Elderly Data from a pharmacokinetic study in elderly subjects (≥ 65 years of age, n = 26) indicated that the apparent steady-state clearance of paliperidone following INVEGA administration was 20% lower compared to that of adult subjects (18-45 years of age, n = 28).
12 Podatki iz farmakokinetične študije pri starejših preiskovancih (starost ≥ 65 let, n=26) so pokazali, da je bil navidezni očistek paliperidona v stanju dinamičnega ravnovesja po jemanju zdravila INVEGA za 20% manjši kot pri odraslih preiskovancih (starost od 18 do 45 let, n=28).
Race Population pharmacokinetics analysis revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following INVEGA administration.
Rasa Analiza populacijske farmakokinetike ni pokazala rasno pogojenih razlik v farmakokinetiki paliperidona po jemanju zdravila INVEGA.
Gender The apparent clearance of paliperidone following INVEGA administration is approximately 19% lower in women than men.
Spol Navidezni očistek paliperidona po jemanju zdravila INVEGA je pri ženskah za približno 19% manjši kot pri moških.
Smoking Status 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.
Kajenje Na podlagi študij in vitro na človeških jetrnih encimih sklepamo, da paliperidon ni substrat izoencima CYP1A2, zato kajenje ne bi smelo vplivati na farmakokinetiko paliperidona.
A population pharmacokinetic analysis showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Analiza populacijske farmakokinetike je pri kadilcih pokazala malo manjšo izpostavljenost paliperidonu v primerjavi z ne- kadilci.
Coated tablet core:
6. 1 Seznam pomožnih snovi
12 Stearic acid Butyl hydroxytoluene (E321) Iron oxide (black) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Jedro obložene tablete: polietilenoksid 200K natrijev klorid povidon (K29- 32) stearinska kislina butilhidroksitoluen (E321) črni železov oksid (E172) polietilenoksid 7000K rdeči železov oksid (E172) hidroksietilceluloza makrogol 3350 celulozni acetat
Colour overcoat:
Barvna obloga: hipromeloza titanov dioksid (E171)
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Ferric oxide (red) (E172) Carnauba wax
13 makrogol 400 rumeni železov oksid (E172) rdeči železov oksid (E172) karnauba vosek
White high-density polyethylene (HDPE) bottle with induction sealing and polypropylene child- resistant closure.
Bele plastenke iz polietilena velike gostote (HDPE) z indukcijsko zaporo in polipropilensko zaporko, varno za otroke.
Each bottle contains two 1 g dessicant silica gel (silicone dioxide) pouches (pouch is food approved polyethylene).
Vsaka plastenka vsebuje dve vrečki (iz polietilena, odobrenega za uporabo pri pakiranju živil) z 1 g sušilnega sredstva iz silikagela (silicijevega dioksida).
Pack sizes of 30 and 350 prolonged-release tablets.
30 in 350 tablet s podaljšanim sproščanjem.
• Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/ aluminium push- through layer.
Velikosti pakiranj:
Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
14, 28, 30, 49, 56 in 98 tablet s podaljšanim sproščanjem.
• White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/ aluminium push- through layer.
Velikosti pakiranj:
13 Or
ali
• Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/ aluminium push-through layer.
• orientiran poliamid (OPA) in aluminijev polivinilklorid (PVC) z aluminijasto pretisno plastjo.
Pack sizes of 14, 28, 49, 56, and 98 prolonged-release tablets.
14, 28, 49, 56 in 98 tablet s podaljšanim sproščanjem.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Janssen- Cilag International NV Turnhoutseweg 30 B- 2340 Beerse Belgija
Each tablet contains 13.2 mg lactose.
Ena tableta vsebuje 13, 2 mg laktoze.
Trilayer capsule-shaped white tablets printed with “ PAL 3”
Triplastne ovalne bele tablete z napisom “ PAL 3 ”
For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 to < 50 ml/ min), the recommended initial dose of INVEGA is 1.5 mg every day, which may be increased to 3 mg once daily
Odmerek se lahko poveča na 3 mg enkrat na dan po
15 after clinical reassessment.
16 ponovni klinični oceni bolnikovega stanja.
However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Patients with Renal Impairment above).
Starostniki Priporočila za odmerjanje zdravila pri starejših bolnikih z normalnim delovanjem ledvic (≥ 80 ml/ min) so sicer enaka kot za odrasle z normalnim delovanjem ledvic, ker pa imajo lahko starejši bolniki zmanjšano delovanje ledvic, bo pri njih morda treba prilagoditi odmerek glede na delovanje bolnikovih ledvic (glejte poglavje Bolniki z ledvično okvaro).
16 Based on pooled data from the three, placebo-controlled, 6-week, fixed-dose trials with INVEGA (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with INVEGA compared with 0.8% of subjects treated with placebo.
Zdravilo INVEGA je treba
INVEGA should be used with caution in patients with known cardiovascular disease (e. g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e. g., dehydration and hypovolemia).
17 uporabljati previdno pri bolnikih z znano srčnožilno boleznijo (npr. srčno popuščanje, miokardni infarkt ali ishemija, motnje prevajanja), z možganskožilnimi boleznimi ali s stanji, ki povečajo nagnjenost bolnika k hipotenziji (npr. dehidracija in hipovolemija).
Seizures INVEGA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Epileptični napadi Zdravilo INVEGA je treba uporabljati previdno pri bolnikih z epileptičnimi napadi v pretekli anamnezi ali z drugimi stanji, ki lahko znižajo prag za epileptični napad.
Parkinson’ s disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing antipsychotic medicinal products, including INVEGA, 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
Parkinsonova bolezen in demenca z Lewyevimi telesci Zdravnik mora pretehtati tveganja in koristi predpisovanja antipsihotikov, vključno z zdravilom INVEGA bolnikom s Parkinsonovo boleznijo ali demenco z Lewyevimi telesci (DLB), ker imata obe skupini lahko povečano tveganje za pojav nevroleptičnega malignega sindroma in tudi povečano občutljivost na antipsihotike.
Priapism Medicines with alpha-adrenergic blocking effects have been reported to induce priapism.
18 Priapizem Poročali so, da zdravila z zaviralnim delovanjem na adrenergične receptorje alfa povzročajo priapizem.
Lactose content (pertains only to the 3 mg tablets) Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Vsebnost laktoze (velja le za 3 mg tablete) Bolniki z redkimi dednimi motnjami galaktozne intolerance, pomanjkanja Lapp laktaze ali malabsorpcije glukoze in galaktoze ne smejo prejemati tega zdravila.
18 Co-administration of INVEGA once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
To znižanje je, v
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.
19 veliki meri, povzročeno s 35% zvišanjem ledvičnega očistka paliperidona, verjetno zaradi indukcije ledvičnega P- gp s karbamazepinom.
19 System Organ Class
20 Razdelitev po organskih sistemih
grand mal convulsion, syncope, dyskinesia, dizziness postural,,
konvulzije tipa grand mal, sinkopa, diskinezija, posturalna omotica
Tachycardia, sinus tachycardia, bundle branch
tahikardija, sinusna tahikardija, blok veje, atrioventrikularni blok prve stopnje, bradikardija
block, atrioventricular block first degree, bradycardia, Vascular disorders Gastrointestinal disorders
Žilne bolezni Bolezni prebavil
System Organ Class Infections and infestations
21 Razdelitev po organskih sistemih
agitation, anorgasmia, anxiety, blunted affect, confusional state, insomnia, libido decreased, listless, mania, middle insomnia, nervousness, restlessness, sleep disorder 20
anoreksija, zmanjšan apetit, diabetična ketoacidoza, polidipsija
conjunctivitis, dry eye, eye discharge, eye rolling, eye swelling, eyelid margin crusting, eyelid oedema, glaucoma, lacrimation increased, ocular hyperaemia, photophobia, vision blurred, visual acuity reduced
akinezija, motnje ravnotežja, bradikinezija, cerebralna ishemija, cerebrovaskularni dogodki, cerebrovaskularne motnje, okorelost po tipu zobatega kolesa, krči, motnje v koordinaciji, zmanjšana stopnja zavesti, diabetična koma, motnje pozornosti, slinjenje, disartrija, hipersomnija, hipoestezija, hipokinezija, letargija, izguba zavesti, obraz maske, motnje gibanja, nenamerne mišične kontrakcije, nevroleptični maligni sindrom, Parkinsonski tremor v mirovanju, motnje govora, tardivna diskinezija, tranzitorna ishemična ataka, neodzivnost na dražljaje
Reproductive system and breast enlargement, ejaculation disorder, ejaculation failure, breast disorders
22 Motnje reprodukcije in dojk
21 Elderly In a study conducted in elderly subjects with schizophrenia, the safety profile was similar to that seen in non-elderly subjects.
starejših preiskovancih s shizofrenijo, je bil profil varnosti zdravila podoben kot pri
EPS included a pooled analysis of the following terms: dyskinesia, dystonia, hyperkinesia, Parkinsonism, and tremor.
Pri EPS so opravili tudi analizo zbranih podatkov za naslednje izraze: diskinezija, distonija, hiperkinezija, parkinsonizem in tremor.
Gastric lavage (after intubation if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered.
23 nezavesten) ter dajanju aktivnega oglja skupaj z odvajalom.
22 Mechanism of Action Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Mehanizem delovanja Paliperidon je selektiven zaviralec učinkov monoaminov in njegove farmakološke lastnosti se razlikujejo od lastnosti tradicionalnih nevroleptikov.
Paliperidone also blocks alfa1-adrenergic receptors and blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
Paliperidon zavira tudi adrenergične receptorje alfa- 1 in v manjši meri tudi histaminske receptorje H1 in adrenergične receptorje alfa- 2.
Intent- to-Treat Analysis Set
24 Lestvica pozitivnih in negativnih simptomov pri shizofreniji (Positive and Negative Syndrome Scale for Schizophrenia- PANSS) Skupna ocena – sprememba od začetne vrednosti do končnega rezultata LOCF za študije R076477- SCH- 303, R076477- SCH- 304 in R076477- SCH- 305: analizirana skupina, ki so jo nameravali zdraviti
Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Srednja začetna vrednost 94, 1 (10, 74) (SD)
94.3 (10.48) -17.9 (22.23) < 0.001 -13.7 (2.63)
Srednja sprememba (SD) - 4, 1 (23, 16) P- vrednost (v primerjavi s placebom)
93.2 (11.90) -17.2 (20.23) < 0.001 -13.5 (2.63)
- 17, 9 (22, 23) - 17, 2 (20, 23) - 23, 3 < 0, 001 < 0, 001
94.6 (10.98) -23.3 (20.12) < 0.001 -18.9 (2.60)
(20, 12) < 0, 001
(N=111) 92.3 (11.96) -15.7 (18.89) 0.006 -7.0 (2.36)
Srednja začetna vrednost 93, 6 (11, 71) (SD)
(N=111) 94.1 (11.42) -17.5 (19.83) < 0.001 -8.5 (2.35)
Srednja sprememba (SD) - 8, 0 (21, 48) P- vrednost (v primerjavi s placebom)
R076477-SCH-305
- 15, 7 (18, 89) 0, 006
(N=120)
(N=120) R076477- SCH- 305
Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Srednja začetna vrednost 93, 9 (12, 66) (SD)
91.6 (12.19) -15.0 (19.61) < 0.001 -11.6 (2.35)
Srednja sprememba (SD) - 2, 8 (20, 89) P- vrednost (v primerjavi s placebom)
Absorption Following a single dose, INVEGA exhibits a gradual ascending release rate, allowing the plasma concentrations of paliperidone to steadily rise to reach peak plasma concentration (Cmax) approximately 24 hours after dosing.
25 Absorpcija Po zaužitju enkratnega odmerka zdravila INVEGA postopno narašča njegova hitrost sproščanja, zaradi česar se plazemske koncentracije paliperidona ves čas zvišujejo in dosežejo največjo plazemsko koncentracijo (Cmax) približno 24 ur po jemanju zdravila.
Biotransformation and elimination One week following administration of a single oral dose of 1 mg immediate-release 14C-paliperidone, 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised by the liver.
Biotransformacija in izločanje En teden po zaužitju enkratnega peroralnega odmerka 1 mg radioaktivno označenega paliperidona- 14C s takojšnjim sproščanjem se je 59% odmerka izločilo v nespremenjeni obliki s sečem, kar pomeni, da v jetrih ne pride do obsežne presnove se paliperidona.
24 Renal Impairment Elimination of paliperidone decreased with decreasing renal function.
Ledvična okvara Izločanje paliperidona se zmanjšuje z zmanjševanjem delovanja ledvic.
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [CrCl] = 50 to < 80 ml/ min), 64% in moderate (CrCl = 30 to < 50 ml/ min), and 71% in severe (CrCl = < 30 ml/ min) renal impairment.
Celotni očistek paliperidona je bil zmanjšan pri preiskovancih z motnjami delovanja ledvic, in sicer za 32% pri blagi ledvični okvari (očistek kreatinina [CrCl] =50 do < 80 ml/ min), za 64% pri zmerni ledvični okvari (CrCl = 30 do < 50 ml/ min) in za 71% pri hudi ledvični okvari (CrCl= < 30 ml/ min).
Elderly Data from a pharmacokinetic study in elderly subjects (≥ 65 years of age, n = 26) indicated that the apparent steady-state clearance of paliperidone following INVEGA administration was 20% lower compared to that of adult subjects (18-45 years of age, n = 28).
26 Starostniki Podatki iz farmakokinetične študije pri starejših preiskovancih (starost ≥ 65 let, n=26) so pokazali, da je bil navidezni očistek paliperidona v stanju dinamičnega ravnovesja po jemanju zdravila INVEGA za 20% manjši kot pri odraslih preiskovancih (starost od 18 do 45 let, n=28).
25 Stearic acid Butyl hydroxytoluene (E321) Ferric oxide (yellow) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Jedro obložene tablete: polietilenoksid 200K natrijev klorid povidon (K29- 32) stearinska kislina butilhidroksitoluen (E321) rumeni železov oksid (E172) polietilenoksid 7000K rdeči železov oksid (E172) hidroksietilceluloza makrogol 3350 celulozni acetat
Colour overcoat:
Barvna obloga:
Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin Carnauba wax
27 hipromeloza titanov dioksid (E171) laktoza monohidrat triacetin karnauba vosek
26 • Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/ aluminium push-through layer.
• orientiran poliamid (OPA) in aluminijev polivinilklorid (PVC) z aluminijasto pretisno plastjo.
6.6 Special precautions for disposal
28 6. 6 Posebni varnostni ukrepi za odstranjevanje
Date of first authorisation:
25.
25/ 06/ 2007
2007
Trilayer capsule-shaped beige tablets printed with “ PAL 6”
Triplastne ovalne rjavkaste tablete z napisom “ PAL 6 ”
However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Patients with Renal Impairment above).
30 Starostniki Priporočila za odmerjanje zdravila pri starejših bolnikih z normalnim delovanjem ledvic (≥ 80 ml/ min) so sicer enaka kot za odrasle z normalnim delovanjem ledvic, ker pa imajo lahko starejši bolniki zmanjšano delovanje ledvic, bo pri njih morda treba prilagoditi odmerek glede na delovanje bolnikovih ledvic (glejte poglavje Bolniki z ledvično okvaro).
INVEGA should be used with caution in patients with known
Zdravilo INVEGA je treba uporabljati previdno pri bolnikih z znano srčnožilno boleznijo (npr. srčno popuščanje, miokardni infarkt ali ishemija, motnje prevajanja), z možganskožilnimi boleznimi ali s stanji, ki povečajo nagnjenost bolnika k hipotenziji (npr. dehidracija in hipovolemija).