natgillin/translations-raw huggingface dataset:
Although extensive metabolisers have lower risperidone and higher 9-hydroxy-risperidone concentrations than poor metabolisers, the pharmacokinetics of risperidone and 9-hydroxy-risperidone combined (i. e., the active antipsychotic fraction), after single and multiple doses, are similar in extensive and poor metabolisers of CYP 2D6.
Čeprav imajo ljudje z boljšo presnovo nižje koncentracije risperidona in višje koncentracije 9- hidroksi- risperidona kot tisti s slabšo presnovo, je skupna farmakokinetika risperidona in 9- hidroksi- risperidona (to je aktivna antipsihotična frakcija), po enkratnem ali večkratnem odmerku, pri obojih podobna.
32 Another metabolic pathway of risperidone is N-dealkylation.
Risperidon se presnavlja tudi z N- dealkilacijo.
In vitro studies in human liver microsomes showed that risperidone at clinically relevant concentration does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4, and CYP 3A5.
In vitro študije na mikrosomih človeških jeter pa so pokazale, da risperidon, v terapevtskih koncentracijah bistveno ne zavira presnove zdravil, ki se presnavljajo z izoencimi citokroma P450, vključno s CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4 in CYP 3A5.
One week after oral risperidone administration, 70% of the dose is excreted in the urine and 14% in the faeces.
En teden po peroralni aplikaciji risperidona, se 70% odmerka izloči z urinom, 14% pa z blatom.
In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the orally administered dose.
Risperidon in 9- hidroksi- risperidon predstavljata 35- 45% peroralnega odmerka v urinu.
Linearity The pharmacokinetics of risperidone following single doses of RISPERDAL CONSTA are linear in the dose range of 12.5-75 mg.
Linearnost Pri odmerkih 12, 5- 75 mg je farmakokinetika risperidona po enkratnem odmerku zdravila Risperdal Consta linearna.
The pharmacokinetics of risperidone are also linear in the dose range of 25-50 mg injected every 2 weeks.
Farmakokinetika risperidona je linearna tudi pri obmerkih 25- 50 mg, injiciranih vsaka 2 tedna.
Elderly, hepatic and renal impairment A single-dose pharmacokinetic study with oral risperidone showed on average a 43% higher active antipsychotic fraction plasma concentrations, a 38% longer half-life and a reduced clearance of the active antipsychotic fraction by 30% in the elderly.
Starejši, jetrna in ledvična okvara Farmakokinetična študija s peroralnim risperidonom je pokazala v povprečju za 43% višje aktivne plazemske koncentracije antipsihotične frakcije, 38% daljši razpolovni čas in zmanjšan očistek aktivne antipsihotične frakcije za 30% pri starejših.
Higher active antipsychotic fraction plasma concentrations and a reduced clearance of the active antipsychotic fraction by on average 60% were observed in patients with renal insufficiency.
Pri bolnikih z motnjami v delovanju ledvic so v povprečju opazili 60% višje plazemske koncentracije aktivne antipsihotične frakcije in 60% zmanjšan očistek aktivne antipsihotične frakcije.
Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
Pri bolnikih z motnjami v delovanje jeter so bile plazemske koncentracije normalne, povprečna prosta frakcija risperidona v plazmi pa je bila povišana za približno 35%.
Pharmacokinetic/ pharmacodynamic relationship There was no relationship between the plasma concentrations of the active antipsychotic fraction and the change in total PANSS (Positive And Negative Syndrome Scale) and total ESRS (Extrapyramidal Symptom Rating Scale) scores across the assessment visits in any of the phase-III trials where efficacy and safety was examined.
Povezava med farmakokinetiko in farmakodinamiko V nobenem preskušanju (faza III), v katerem so proučevali varnost in učinkovitost risperidona, niso ugotovili povezave med koncentracijami aktivne antipsihotične frakcije v plazmi in spremembo v skupnem rezultatu na lestvici pozitivnih in negativnih sindromov (PANSS- Positive And Negative Syndrome Scale) ter lestvici ekstrapiramidnih simptomov (ESRS- Extrapyramidal Symptom Rating Scale).
Gender, race and smoking habits A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction.
Spol, rasa in kajenje Analiza populacijske farmakokinetike ni pokazala vplivov spola, rase ali kajenja na farmakokinetiko risperidona ali aktivne antipsihotične frakcije.
Similar to the (sub)chronic toxicity studies with oral risperidone in rats and dogs, the major effects of treatment with RISPERDAL CONSTA (up to 12 months of intramuscular administration) were prolactin-mediated mammary gland stimulation, male and female genital tract changes, and central nervous system (CNS) effects, related to the pharmacodynamic activity of risperidone.
Podobno kot v študijah (sub) kronične toksičnosti s peroralnim risperidonom na podganah in psih, so bili glavni učinki zdravljenja z zdravilom RISPERDAL CONSTA (do 12 mesecev intramuskularne uporabe), s prolaktinom povzročena stimulacija mlečne žleze, spremembe samčevih in samičjih spolovil ter učinki na osrednji živčni sistem (CŽS), ki so povezani s farmakodinamično aktivnostjo risperidona.
RISPERDAL CONSTA administration to male and female rats for 12 and 24 months produced osteodystrophy at a dose of 40 mg/ kg/ 2 weeks.
33 Pri injiciranju zdravila RISPERDAL CONSTA podganjim samcem in samicam 12 in 24 mesecev se je pojavila osteodistrofija pri odmerku 40 mg/ kg/ 2 tedna.
The effect dose for osteodystrophy in rats was on a mg/ m2 basis 8 times the maximum recommended human dose and is associated with a plasma exposure 2 times the maximum anticipated exposure in humans at the maximum recommended dose.
Odmerek pri katerem se je pri podganah pojavila osteodistrofija, je bil preračunano na mg/ m2, 8- krat višji od največjega priporočenega odmerka pri ljudeh in je bil povezan z 2- krat višjo plazemsko izpostavljenostjo, ki je pričakovana pri najvišjem priporočenem odmerku.
No osteodystrophy was observed in dogs treated for 12 months with RISPERDAL CONSTA up to 20 mg/ kg/ 2 weeks.
Pri psih, ki so jim dajali zdravilo RISPERDAL CONSTA 12 mesecev do odmerka 20 mg/ kg/ 2 tedna ni prišlo do osteodistrofije.
This dose yielded plasma exposures up to 14 times the maximum recommended human dose.
Pri tem odmerku je bila plazemska koncentracija do 14- krat višja od največjega priporočenega odmerka pri ljudeh.
33 As expected for a potent dopamine D2-antagonist, in oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Po pričakovanjih so pri močnem D2- antagonistu dopamina v študijah peroralne kancerogenosti z risperidonom pri podganah in miših opazili povečanje pogostnosti adenomov žleze hipofize (pri miših), adenomov endokrinega dela trebušne slinavke (pri podganah) in adenomov mlečne žleze (pri obeh vrstah).
In an intramuscular carcinogenicity study with RISPERDAL CONSTA in Wistar (Hannover) rats (doses of 5 and 40 mg/ kg/ 2 weeks), increased incidences of endocrine pancreas, pituitary gland, and adrenal medullary tumours were observed at 40 mg/ kg, while mammary gland tumours were present at 5 and 40 mg/ kg.
40 mg/ kg, v odmerkih 40 mg/ kg povzročil zvečano pojavnost tumorjev endokrinega pankreasa, hipofize ter nadledvične in ledvične žleze, ki jih povzroča prolaktin, medtem ko so se tumorji mlečne žleze pojavili pri odmerku 5 mg/ kg in 40 mg/ kg.
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Študije na tkivnih kulturah so pokazale, da prolaktin lahko spodbudi rast rakavih celic pri raku dojke.
Renal tubular adenomas occurred in male rats treated with RISPERDAL CONSTA at 40 mg/ kg/ 2 weeks.
Ledvični tubulni adenomi so se pojavili pri podganjih samcih, ki so prejemali zdravilo RISPERDAL CONSTA v odmerku 40 mg/ kg/ 2 tedna.
No renal tumours occurred in the low dose, the NaCl 0.9%, or the microspheres vehicle control group.
Ledvični tumorji se niso pojavili pri nizkih odmerkih ter v kontrolnih skupinah, ki so prejemali 0, 9% NaCl ali vehikel.
Studies conducted to explore the substrain differences in the tumour organ profile suggest that the Wistar (Hannover) substrain employed in the carcinogenicity study differs substantially from the Wistar (Wiga) substrain employed in the oral carcinogenicity study with respect to spontaneous age-related non-neoplastic renal changes, serum prolactin increases, and renal changes in response to risperidone.
Študije s katerimi so želeli ugotoviti razliko v naravi tumorjev nakazujejo, da se vrsta Wistar (Hannover), ki so jo uporabljali v študijah kancerogenosti, značilno razlikuje od vrste Wistar (Wiga), na kateri so preskušali peroralno kancerogenost, in je podvržena nastanku spontanih ne- neoplastičnih ledvičnih sprememb, zvišanje serumskega prolaktina in ledvičnim spremembam odvisnim od risperidona.
In a 24-month intramuscular carcinogenicity study in rats, no increased incidence of injection site tumours was seen in either the vehicle or active groups.
V 24- mesečnih intramuskularnih študijah kancerogenosti na podganah, na mestu injiciranja niso opazili zvečane pojavnosti tumorjev.
6.2 Incompatibilities
34 6. 2 Inkompatibilnosti
RISPERDAL CONSTA extended release microspheres in the vial must be reconstituted only in the solvent in the syringe supplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
35 6. 6 Navodila za uporabo/ rokovanje in uničenje Navodila za uporabo pakiranja s tremi iglami Prašek RISPERDAL CONSTA v viali, smemo rekonstituirati samo v vehiklu v napolnjeni injekcijski brizgi, ki je priložena v škatlici, uporabite pa ga lahko le s priloženo Needle- Pro varnostno iglo.
Administration of partial contents may not deliver the intended dose of risperidone.
Uporaba v večih delih ne zagotavlja prejema priporočenega odmerka risperidona
Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
igla za i. m. injiciranje
Contents of the dose pack:
Bela zaporka bela zaporka
• One vial containing RISPERDAL CONSTA extended release microspheres • Two Hypoint 20G 2” TW needles for reconstitution • One prefilled syringe containing the solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle with needle protection device)
Vsebina škatlice: • Ena viala, ki vsebuje RISPERDAL CONSTA v obliki mikrosfer s podaljšanim sproščanjem. • Dve Hypoint 20 G 2” TW igle za rekonstitucijo • Ena napolnjena injekcijska brizga, ki vsebuje vehikel za RISPERDAL CONSTA. • Eno iglo Needle- Pro za intramuskulano injiciranje (varnostna igla 20G 2” TW s pripomočkom, ki ščiti iglo).
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside.
Napolnjeno injekcijsko brizgo odpremo tako, da zlomimo varovalo na beli zaporki, belo zaporko pa nato odstranimo skupaj z notranjo gumijasto zaporko.
Pull sheath away from the needle – do not twist.
Z igle s potegom odstranimo varovalni tulec.
Inject the entire contents (solvent) of the syringe into the vial.
V vialo injiciramo celotno vsebino (vehikel) iz injekcijske brizge.
Keeping the empty syringe and needle aligned, attach the second needle with an easy clockwise twisting motion to the luer connection of the syringe.
37 Drugo iglo z lahnim zasukom v smeri urinega kazalca namestimo na nastavek luer na injekcijski brizgi pri tem pazimo, da sta prazna brizga in igla poravnani.
Mixing is complete when the suspension appears uniform, thick, and milky in colour, and all the powder is fully dispersed.
Mešanje je končano, ko suspenzija postane enotna, gosta in mlečne barve, ves prašek pa se popolnoma porazdeli.
Take the syringe and pull sheath away from the reconstitution needle – do not twist.
Tulca ne smemo sukati.
Withdraw the syringe with the reconstitution needle from the vial.
Injekcijsko brizgo z iglo izvlečemo iz viale.
Peel the blister pouch of the Needle-Pro device open half way.
10 Zaščitni omot, v katerem je pripomoček Needle- Pro, odpremo do polovice.
Grasp sheath using the plastic peel pouch.
Varovalni tulec snamemo z igle skupaj z zaščitnim omotom.
Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe.
Na injekcijsko brizgo z lahnim zasukom v smeri urinega kazalca pritrdimo nastavek luer na Needle- Pro pripomočku.
Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
Iglo s pritiskom in zasukom v smeri urinega kazalca trdno pričvrstimo na pripomoček Needle- Pro.
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
MOČNO STRESAMO TOLIKO ČASA, DA SE ZMES RESUSPENDIRA.
Pull sheath away from the needle – do not twist sheath as needle may be loosened from Needle- Pro device.
Tulca ne smemo sukati, saj lahko spoj med iglo in pripomočkom Needle- Pro popusti.
WARNING:
• • •
To avoid a needle stick injury with a contaminated needle, do not: • Intentionally disengage the Needle-Pro device • Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged • Mishandle the needle protection device that could lead to protrusion of the needle from it 38 12.
namenoma odstraniti pripomočka Needle- Pro, izravnati igle ali pritrditi pripomočka Needle- Pro, če je igla skrivljena ali poškodovana, neprevidno ravnati s pripravo za zaščito injekcijske igle, saj lahko igla pomoli iz varovalnega tulca.
After procedure is completed, press the needle into the needle protection device.
Po zaključenem postopku iglo z eno roko potisnemo v varovalni tulec.
Perform a one- handed technique by GENTLY pressing the needle protection device against a flat surface.
Varovalni tulec z eno roko NARAHLO upremo ob ravno površino.
As the needle protection device is pressed, the needle is firmly engaged into it.
Ob pritisku se igla in varovalni tulec zaskočita.
Visually confirm that the needle is fully engaged into the needle protection device.
Preverite, da se igla popolnoma prilega varovalni kapici.
Do not substitute any components in the dose pack.
Prašek RISPERDAL CONSTA v viali, smemo rekonstituirati samo v vehiklu v napolnjeni injekcijski brizgi, ki je priložena v škatlici, uporabite pa ga lahko le s priloženo Needle- Pro varnostno iglo. Ne zamenjujte sestavin v škatlici.
Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
Pripomoček za rekonstitucijo mesto za Luer nastavek
Contents of the dose pack:
igla za i. m. injiciranje
• One vial containing RISPERDAL CONSTA extended release microspheres • One Alaris SmartSite needle-free vial access device for reconstitution • One prefilled syringe containing the solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle-with needle protection device)
Vsebina škatlice: • Ena viala, ki vsebuje RISPERDAL CONSTA v obliki mikrosfer s podaljšanim sproščanjem. • En ALARIS SmartSite pripomoček za rekonstitucijo. • Ena napolnjena injekcijska brizga, ki vsebuje vehikel za RISPERDAL CONSTA. • Eno iglo Needle- Pro za intramuskulano injiciranje (varnostna igla 20G 2” TW s pripomočkom, ki ščiti iglo).
Peel back the blister pouch and remove the vial access device by holding the white luer cap.
Odpremo zaščitni omot, v katerem je nastavek, tako da ga držimo za belo LUER zaporko.
Do not touch the spike tip of the access device at any time.
V nobenem primeru se ne dotikamo igle na pripomočku za rekonstitucijo.
With a straight push down movement press the spike tip of the vial access device through the centre of the vial’ s rubber stopper until the device securely snaps onto the vial top.
Z močnim potiskom navzdol konico pripomočka potisnemo skozi sredino gumijaste zaporke viale, da pripomoček zanesljivo pritrdimo na vrh viale.
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside.
Napolnjeno brizgo odpremo tako, da zlomimo varovalo, belo zaporko pa nato odstranimo skupaj z notranjo gumijasto zaporko. bela zaporka
Inject the entire contents (solvent) of the syringe into the vial.
Celotno vsebino injekcijske brizge (vehikel) vbrizgamo v vialo.
Mixing is complete when the suspension appears uniform, thick, and milky in colour and all the powder is fully dispersed.
Mešanje je končano, ko suspenzija postane enotna, gosta in mlečne barve, ves prašek pa se popolnoma porazdeli.
Unscrew the syringe from the vial access device.
Injekcijsko brizgo odvijemo z nastavka za rekonstitucijo.
Peel the blister pouch of the Needle-Pro device open half way.
Zaščitni omot, v katerem je pripomoček Needle- Pro, odpremo do polovice.
Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe.
Na injekcijsko brizgo z lahnim zasukom v smeri urinega kazalca pritrdimo nastavek LUER na Needle- Pro pripomočku.
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
MOČNO STRESAMO TOLIKO ČASA, KOLIKOR JE POTREBNO, DA SE ZMES RESUSPENDIRA.
DO NOT ADMINISTER INTRAVENOUSLY.
44 NE APLICIRAJTE INTRAVENSKO.
43 WARNING:
OPOZORILO:
To avoid a needle stick injury with a contaminated needle, do not: • Intentionally disengage the Needle-Pro device • Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged • Mishandle the needle protection device that could lead to protrusion of the needle from it
Da se izognemo poškodbam s kontaminirano iglo, ne smemo: • namenoma odstraniti pripomočka Needle- Pro, • izravnati igle ali pritrditi pripomočka Needle- Pro, če je igla skrivljena ali poškodovana, • neprevidno ravnati s pripravo za zaščito injekcijske igle, saj lahko igla pomoli iz njega.
Perform a one- handed technique by GENTLY pressing the needle protection device against a flat surface.
Pripomoček z eno roko NARAHLO upremo ob ravno površino.
As the needle protection device is pressed, the needle is firmly engaged into it.
Ob pritisku se igla in pripomoček za njeno zaščito zaskočita.
[See Annex I – To be completed nationally]
[Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno]
44 LABELLING
47 OZNAČEVANJE
Outer Carton (Pack with ALARIS)
Zunanja škatla (pakiranje ALARIS)
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA ® in sorodna imena (glejte Dodatek 1) 25 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA ® in sorodna imena (glejte Dodatek 1) 37, 5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA ® in sorodna imena (glejte Dodatek 1) 50 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Powder and solvent for prolonged-release suspension for injection.
Prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
[See Annex I - To be completed nationally]
[Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno]
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally]
Risperdal Consta® in sorodna imena (glejte Dodatek 1) 12, 5 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem [Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno]
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA ® in sorodna imena (glejte Dodatek 1) 25 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA ® in sorodna imena (glejte Dodatek 1) 37, 5 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA ® in sorodna imena (glejte Dodatek 1) 50 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem
Solvent for RISPERDAL CONSTA 12.5 mg/ 25 mg/ 37.5 mg/ 50 mg and associated names (see Annex I) [See Annex I – To be completed nationally]
Vehikel za zdravilo RISPERDAL CONSTA 12, 5 mg/ 25 mg/ 37, 5 mg/ 50 mg in sorodna imena (glejte Dodatek I) [Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno]
Keep prefilled syringe in the outer carton
Shranjujte injekcijske brizge v zunanji ovojnini.
53 PACKAGE LEAFLET
56 NAVODILO ZA UPORABO
RISPERDAL CONSTA and associated names (see Annex I) 12.5, 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally] Risperidone
RISPERDAL CONSTA ® 12, 5 mg, 25 mg, 37, 5 mg in 50 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem [Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno] Risperidon
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Pred uporabo natančno preberite navodilo! − Navodilo shranite.
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati. − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom. − To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim. − Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What RISPERDAL CONSTA is and what it is used for 2.
Kaj je zdravilo RISPERDAL CONSTA in za kaj ga uporabljamo 2.
Before you use RISPERDAL CONSTA 3.
Kaj morate vedeti, preden boste uporabili zdravilo RISPERDAL CONSTA 3.
How to use RISPERDAL CONSTA 4.
Kako uporabljati zdravilo RISPERDAL CONSTA 4.
How to store RISPERDAL CONSTA 6.
Shranjevanje zdravila RISPERDAL CONSTA 6.
WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO RISPERDAL CONSTA IN ZA KAJ GA UPORABLJAMO
RISPERDAL CONSTA belongs to a group of medicines called ‘ anti-psychotics’.
Zdravilo RISPERDAL CONSTA uvrščamo v skupino zdravil imenovano antipsihotiki.
RISPERDAL CONSTA is used to maintain the treatment of schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused
Zdravilo RISPERDAL CONSTA se uporablja za vzdrževalno zdravljenje shizofrenije s simptomi, kot so prividi, prisluhi, občutki, ki niso resnični, neobičajna sumničavost ali zmedenost.
RISPERDAL CONSTA is intended for patients who are currently treated with oral (e. g. tablets, capsules) antipsychotics.
Zdravilo RISPERDAL CONSTA je namenjeno bolnikom, ki se trenutno zdravijo z antipsihotiki v peroralni obliki (tablete, kapsule).
BEFORE YOU USE RISPERDAL CONSTA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO RISPERDAL CONSTA
Do not take RISPERDAL CONSTA • If you are allergic (hypersensitive) to risperidone or any of the other ingredients of RISPERDAL CONSTA (listed in Section 6 below).
Ne uporabljajte zdravila RISPERDAL CONSTA • če ste alergični (preobčutljivi) na risperidon ali katerokoli sestavino zdravila RISPERDAL CONSTA (navedeno v poglavju 6.).