natgillin/translations-raw huggingface dataset:
• Rifampicin (a medicine for treating some infections) 
• rifampicin (zdravilo za zdravljenje nekaterih okužb)
• Yellowing of the skin and the eyes (jaundice) 
• porumenelost kože in oči (zlatenica)
Aebe Eirinis Avenue 56, Pefki, 15121, Greece suspension for injection 
Aebe Eirinis Avenue 56, Pefki, 15121, Grčija suspenzijo za injiciranje
• Inappropriate secretion of a hormone that controls urine volume 
• nepravilno izločanje hormona, ki uravnava količino urina
• You have Parkinson's disease or dementia 
• če imate Parkinsonovo bolezen ali demenco
• Body shakes rapidly and uncontrollably (convulsion) 
• hitro, nenadzorovano tresenje telesa (konvulzije)
Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenia 
Slovenija Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenija
For section 4.1, the indication “schizophrenic disorders” was assessed in details, as the existing divergences were likely to have implications for the selection of the treatment population and for the dose regiment and concomitant treatments. 
V poglavju 4.1 je bila podrobno preučena indikacija „shizofrenične motnje“, saj obstoječa neskladja lahko vplivajo na izbiro zdravljenja za posamezne populacije in na način odmerjanja in sočasna zdravljenja.
If you start or stop taking such medicines you may need a different dose of risperidone 
Če začnete ali prenehate jemati ta zdravila, boste morda potrebovali drugačen odmerek risperidona.
Place vial on a hard surface. 
Vialo postavimo na trdno površino.
Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings. 
Sočasna uporaba risperidona z drugimi diuretiki (v glavnem s tiazidnimi diuretiki v majhnih odmerkih) ni bila povezana s podobnimi ugotovitvami.
• Decrease in white blood cells that help against infection, decrease in platelets (blood cells that help you stop bleeding). 
• zmanjšanje števila belih krvnih celic, ki pomagajo pri obrambi proti infekcijam, zmanjšanje števila krvnih ploščic (krvne celice, ki pomagajo zaustaviti krvavitev).
Risperidone is a selective monoaminergic antagonist with unique properties. 
Risperidon je selektiven monoaminergičen antagonist s svojstvenimi značilnostmi.
For section 4.6, the CHMP discussed the wording, moving the mention of galactorrhea to section 4.8 and adopting the following harmonised wording: 
V poglavju 4.6 je CHMP preučil besedilo in premaknil omembo galaktoreje v poglavje 4.8 ter sprejel naslednje usklajeno besedilo:
The CHMP agreed that no non-inferiority study is required and the following wording for section 4.1 was adopted: 
Odbor se je strinjal, da ni potrebe po študiji enakovrednosti in potrdil naslednjo ubeseditev za poglavje 4.1:
• Phenobarbital 
• fenobarbital
JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Spain 
JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Španija
In overdose, QT-prolongation and convulsions have been reported. 
Pri prekomernem odmerjanju so poročali o podaljšanju QT-dobe in konvulzijah.
Based on the available data, the CHMP is of the opinion that all raised question were adequately addressed and that the harmonised Product Information wording is acceptable. 
Na osnovi razpoložljivih podatkov je CHMP menil, da so na vsa odprta vprašanja bili predloženi ustrezni odgovori ter da je usklajeno besedilo informacij o zdravilu sprejemljivo.
Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3). 
V študijah na živalih risperidon ni bil teratogen, so se pa pokazali ostali vplivi na sposobnost razmnoževanja (glejte poglavje 5.3).
For section 4.4, the CHMP implemented the wording on tardive dyskinesia, agreed upon by the Pharmacovigilance Working Party. 
V poglavju 4.4 je CHMP sprejel besedilo glede tardivne diskinezije, o katerem se je strinjala tudi delovna skupina za farmakovigilanco.
Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway 
Norveška Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norveška
Anorexia, Polydipsia 
Anoreksija, polidipsija
The elimination phase is complete approximately 7 to 8 weeks after the last RISPERDAL CONSTA injection. 
Faza eliminacije je zaključena približno 7 do 8 tednov po zadnji injekciji zdravila RISPERDAL CONSTA.
Risperidone was not teratogenic in rat and rabbit. 
Risperidon ni bil teratogen pri podganah in kuncih.
Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring. 
Tudi drugi antagonisti dopamina so po dajanju brejim živalim povzročili negativne učinke na učenje in motorični razvoj pri mladičih.
In vitro and in vivo, animal models show that at high doses risperidone may cause QT interval prolongation, which has been associated with a theoretically increased risk of torsade de pointes in patients. 
In vitro in in vivo študije na živalskih modelih kažejo, da visoki odmerki lahko povzročijo podaljšanje QT intervala, kar povezujejo s teoretičnim povečanjem tveganja za pojav Torsade de pointes pri bolnikih.
The intramuscular long-acting injection (LAI) formulation provides slow and steady release of risperidone over a period of several weeks. 
Pripravek za intramuskularno injekcijo s podaljšanim delovanjem (LAI) zagotavlja počasno in konstantno sproščanje risperidona v obdobju nekaj tednov.
For section 4.3, the CHMP discussed the relevance of a Contraindication warning for patients with high risk factors for cerebrovasular adverse events. 
V poglavju 4.3 je CHMP preučil pomen opozorila glede kontraindikacij pri bolnikih z visokim faktorjem tveganja za cerebrovaskularne neželene dogodke.
• Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants 
• antidepresivi, kot so paroksetin, fluoksetin, triciklični antidepresivi
• You have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin. 
• imate nenormalno visoko koncentracijo hormona prolaktina v krvi ali imate tumor, ki je odvisen od prolaktina.
The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1). 
Razmerje verjetnosti (95 % interval zaupanja) je bilo 1,21 (0,7; 2,1).
Weight should be measured regularly. 
Telesno maso je treba redno spremljati.
The CHMP was also of the opinion that doses of risperidone > 8 mg/day should not be routinely used and should be restricted to certain group of patients. 
CHMP je menil, da se odmerkov risperidona >8mg ne bi smelo rutinsko predpisovati ter da naj bodo omejeni le na določene skupine bolnikov.
The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50). 
Razmerje verjetnosti (95 % interval zaupanja) je bilo 2,96 (1,34; 7,50).
The efficacy of the 12.5 mg dose has not been investigated in clinical trials. 
Učinkovitost 12,5 mg odmerka risperidona ni bila dokazana v kliničnih preskušanjih.
Very rare side effects (affects less than 1 user in 10,000) may include: • Life-threatening complications of uncontrolled diabetes. 
Zelo redki neželeni učinki (pojavijo se pri manj kot 1 uporabniku na vsakih 10.000) • življenjsko nevarni zapleti pri nenadzorovani sladkorni bolezni
The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. 
Povečano smrtnost pri bolnikih, ki so se sočasno zdravili s furosemidom in risperidonom so ugotovili v dveh od opravljenih štirih kliničnih preskušanj.
As with other antipsychotics, patients should be advised of the potential for weight gain. 
Kot pri drugih antipsihotikih, moramo bolnike opozoriti, da lahko pridobijo na telesni masi.
Netherlands Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240 
Nizozemska Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240
UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilnius, Lithuania 
UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilna, Litva
Although risperidone is a potent D2 antagonist, that is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics. 
Čeprav je risperidon močan D2 antagonist, za katerega velja, da izboljšuje pozitivne simptome shizofrenije, zavira motorično aktivnost v manjši meri in povzroča manj katalepsije kot klasični antipsihotiki.
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.
Sexual dysfunction, Gynaecomastia 
Občasni spolna disfunkcija, ginekomastija
low blood pressure, abnormal electrical tracing of the heart (ECG) 
znižan krvni tlak, nepravilnosti v spremljanju električne aktivnosti vašega srca (EKG)
In case of severe extrapyramidal symptoms, anticholinergic medicinal product should be administered. 
V primeru hudih ekstrapiramidnih simptomov moramo dati antiholinergična zdravila.
Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilnius Lithuania 
Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilna
The CHMP was also of the opinion that the proposed wording of the SPC gives enough flexibility to the treating physician to start with the dose of 25 mg or higher. 
CHMP je tudi menil, da predlagano besedilo povzetka glavnih značilnosti zdravila lečečemu zdravniku daje zadostno fleksibilnost, da prične zdravljenje z odmerkom 25 mg ali večjim.
RISPERDAL CONSTA has not been studied in elderly patients with dementia, hence it is not indicated for use in this group of patients. 
Zdravilo RISPERDAL CONSTA ni bilo preskušano pri starejših bolnikih z demenco, zato ni indicirano za uporabo pri tej skupini bolnikov.
Immediately discard appropriately. 
Takoj jo zavrzite v skladu s predpisi.
Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child. 
Zato morate pretehtati prednosti dojenja glede na možno tveganje za otroka.
Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials. 
Tveganje za pojav nevroleptičnega malignega sindroma in povečane občutljivosti na antipsihotična zdravila je pri obeh skupinah bolnikov večje; ti bolniki niso bili vključeni v klinična preskušanja.
This is a medical term that includes many symptoms. 
• Parkinsonizem je medicinski izraz, ki vsebuje številne simptome.
Invert the vial completely and slowly withdraw the entire contents of the suspension from the vial. 
Vialo obrnemo in počasi povlečemo vso suspenzijo iz viale.
In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone. 
Znaki in simptomi, o katerih so poročali, so bili v glavnem posledica potenciranja že znanih farmakoloških učinkov zdravila.
• Headache, nose and throat infection 
• glavobol, okužba nosu in grla
• Medicines to treat elevated blood pressure. 
• zdravila ki znižujejo krvni tlak.
In rats, intrauterine exposure to risperidone was associated with cognitive deficits in adulthood. 
Pri podganah je bila intrauterina izpostavljenost risperidonu povezana z kognitivnim primanjkljajem v odrasli dobi.
• Cimetidie, ranitidine (blockers of the acidity of stomach) If you start or stop taking such medicines you may need a different dose of risperidone 
• cimetidin, ranitidin (zdravili za zmanjševanje želodčne kisline) Če začnete ali prenehate jemati ta zdravila, boste morda potrebovali drugačen odmerek risperidona.
For intramuscular use only. 
Samo za intramuskularno uporabo.
The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues: 
CHMP je predlagano besedilo imetnika dovoljenja za promet z zdravilom preučil s posebno pozornostjo glede naslednjih vprašanj:
• Carbamazepine, phenytoin (mdicines for epilepsy) 
• karbamazepin, fenitoin (zdravili za zdravljenje epilepsije)
Your dose may need to be adjusted. 
Morda bo potrebno prilagoditi odmerek zdravila.
• Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged 
• izravnati igle ali pritrditi pripomočka Needle-Pro, če je igla skrivljena ali poškodovana,
• No granulocytes (a type of white blood cell to help you against infection) 
• odsotnost granulocitov (vrsta belih krvnih celic, ki pomaga pri obrambi proti infekcijam)
See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide. 
Glejte poglavje 4.4, glede povečane smrtnosti pri starejših bolnikih z demenco ob sočasni uporabi furosemida in peroralnih oblik zdravila RISPERDAL.
• Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much fluid (such as furosemide or chlorothiazide). 
• tablete za odvajanje vode (diuretiki), ki se uporabljajo pri težavah s srcem ali otekanju delov telesa zaradi zadrževanja odvečne tekočine (kot sta furosemid ali klorotiazid).
Like all medicines, RISPERDAL CONSTA can cause side effects, although not everybody gets them. 
Kot vsa zdravila, ima lahko tudi zdravilo RISPERDAL CONSTA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
To assure that the intended dose of risperidone is delivered, the full contents from the vial must be administered. 
Da omogočimo prejem predvidenega odmerka, moramo uporabiti vso vsebino iz viale.
Finally, « Extrapyramidal symptoms » should be the grouped term in the subparagraph Nervous System Disorders and the single symptoms should be mentioned with an asterix. 
„Ekstrapiramidni simptomi“ naj bodo skupni izraz v podskupini nervozne sistemske motnje, posamezni simptomi pa naj bodo označeni z zvezdico.
Similar effects may be observed with e.g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein. 
Podoben učinek lahko pričakujemo pri rifampicinu, fenitoinu in fenobarbitalu, ki inducirajo CYP 3A4 jetrne encime kot tudi P-glikoprotein.
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.
Due to the known efficacy and safety profile of risperidone, this additional dose is approvable without its own efficacy data and can be based solely on the PK data. 
Zaradi znanega profila učinkovitosti in varnosti risperidona je ta dodatni odmerek možno odobriti le na osnovi farmakokinetičnih podatkov, brez podatkov o lastni učinkovitosti.
The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. 
Pojav ekstrapiramidnih simptomov je dejavnik tveganja za nastanek tardivne diskinezije.
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. 
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.
• Medicines that work on your brain to help you calm down (benzodiazepines), or some medicines for pain (opiates), medicines for allergy (some antihistamines), as Risperidone may increase the sedative effect of all of these. 
• zdravila, ki delujejo na vaše možgane in vam pomagajo, da se pomirite (benzodiazepini), nekatera zdravila proti bolečinam (opioidi), zdravila proti alergijam (nekateri antihistaminiki), ker risperidon lahko poveča sedativni učinek teh zdravil
In this event, all antipsychotics, including RISPERDAL CONSTA, should be discontinued. 
V tem primeru je treba prenehati uporabljati vsa antipsihotična zdravila, tudi zdravilo RISPERDAL CONSTA.
Janssen-Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Greece 
Janssen-Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Grčija
• Sudden swelling of lips and eyes along with difficulty breathing, allergy 
• nenadno otekanje ustnic in oči ter oteženo dihanje, alergije
If you are currently treated with other oral antipsychotics than risperidone, your starting dose of RISPERDAL CONSTA will depend on your current treatment. 
Če trenutno jemljete kakšen drug antipsihotik v peroralni obliki, bo vaš začetni odmerek zdravila RISPERDAL CONSTA odvisen od vašega trenutnega zdravljenja.
Torsade de Pointes has been reported in association with combined overdose of oral RISPERDAL and paroxetine. 
O Torsades de pointes so poročali v povezavi s prevelikimi odmerki kombinacije peroralnega risperidona in paroksetina.
Using RISPERDAL CONSTA with food and drink You should avoid drinking alcohol when using RISPERDAL CONSTA. 
Uporaba zdravila RISPERDAL CONSTA skupaj s hrano in pijačo Med jemanjem zdravila RISPERDAL CONSTA se morate izogibati alkoholu.
Procedural pain 
Občasni procesualna bolečina
An increased risk cannot be excluded for other antipsychotics or other patient populations. 
Mehanizem za to povečanje tveganja ni znan, Povečanega tveganja se ne da izključiti pri uporabi drugih antipsihotikov ali populacijah bolnikov.
Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia. 
Uravnotežen osrednji antagonizem serotonina in dopamina lahko zmanjša občutljivost za ekstrapiramidne neželene učinke in razširi terapevtsko učinkovitost na negativne in afektivne simptome shizofrenije.
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.
• Change in consciousness with increased body temperature and twitching of muscles 
• motnje zavesti s povišano telesno temperaturo in trzanjem mišic
• Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems 
• zdravila, ki spremenijo električno prevodnost vašega srca, npr. zdravila proti malariji, težave s srčnim ritmom (kot je kinidin), alergije (antihistaminiki), nekateri antidepresivi ali ostala zdravila za psihične probleme
Do not use RISPERDAL CONSTA after the expiry date which is stated on the carton. 
Zdravila RISPERDAL CONSTA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
In conclusion, the CHMP was not in favour of restricting the use of long-acting risperidone for patients who were administered with 6 mg risperidone per day. 
Zato se CHMP ni strinjal z omejitvijo uporabe dolgo delujočega risperidona pri bolnikih, ki so prejemali 6 mg odmerek risperidona na dan.
The CHMP also assessed the proposed 12.5 mg dosing, in particular with regards to the elderly population, and considered that the 12.5 mg dose of Risperdal Consta would provide additional dosing flexibility but stressed that this dose is intended only as a lower initial dose to establish tolerability, to be used mainly for patients with a higher sensitivity to the effects of the drug, either because of reduced metabolism/excretion, or in patients with an intrinsic lower tolerability to psychotropic medication. 
CHMP je preučil tudi predlagan odmerek 12,5 mg, zlasti glede uporabe pri starejši populaciji in menil, da bi 12,5 mg odmerek zdravila Risperdal Consta zagotovil dodatno fleksibilnost pri odmerjanju ter hkrati poudaril, da je takšen odmerek namenjen le kot manjši začetni odmerek za oblikovanje tolerabilnosti pri bolnikih z večjo občutljivostjo na učinke zdravila zaradi upočasnjenega presnavljanja//izločanja ali pa pri bolnikih z notranjo slabšo toleranco na psihotropna zdravila.
It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. 
Ima visoko afiniteto za serotoninske receptorje 5-HT2 in dopaminske D2 receptorje.
These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. 
Ti vključujejo zaspanost in sedacijo, tahikardijo in hipotenzijo ter ekstrapiramidne simptome.
[To be completed nationally] 
[Poglavje bo dopolnjeno nacionalno]
RISPERDAL CONSTA can lower blood pressure 
Zdravilo RISPERDAL CONSTA lahko zniža krvni tlak
The CHMP further assessed the need for special mention of hyperprolactinaemia and stimulation of cell growth in breast tumours linked to prolactin. 
Odbor je preučil tudi potrebo po posebni omembi hiperprolaktinemije in stimulacije rasti celic pri tumorjih dojk, povezani s prolaktinom.
There are no data available on adverse effects in breast-feeding infants. 
O neželenih učinkih pri dojenih dojenčkih ni nobenih razpoložljivih podatkov.
Care must be taken to avoid inadvertent injection of RISPERDAL CONSTA into a blood vessel. 
Potrebna je previdnost, da ne pride do nenamernega injiciranja zdravila RISPERDAL CONSTA v krvno žilo.
• Two Hypoint 20G 2” TW needles for reconstitution 
• Dve Hypoint 20 G 2”TW igle za rekonstitucijo
In plasma, risperidone is bound to albumin and alpha-1-acid glycoprotein. 
V plazmi se risperidon veže na albumin in α1-kisli glikoprotein.
The mean age (range) of patients who died was 86 years (range 67-100). 
Povprečna starost (območje) umrlih bolnikov je bila 86 let (območje
• If you have any further questions, ask your doctor or pharmacist. 
− Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
RISPERDAL CONSTA may antagonise the effect of levodopa and other dopamine agonists. 
Zdravilo RISPERDAL CONSTA lahko zavira učinek levodope in drugih dopaminskih agonistov.
RISPERDAL does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate. 
Zdravilo RISPERDAL ne kaže klinično pomembnega vpliva na farmakokinetiko litija, valproata, digoksina ali topiramata.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. 
Nobenega patofiziološkega mehanizma, niti vzorca o vzrokih smrtnosti, niso opazili.
The pooled data from six placebo-controlled studies in mainly elderly patients (>65 years of age) with dementia showed that CVAEs (serious and nonserious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo. 
Skupni podatki šest, s placebom nadzorovanih študij pri večinoma starejših bolnikih (>65 let) z demenco so pokazali, da so se cerebrovaskularni neželeni dogodki (resni in neresni, skupaj) pojavili pri 3,3 % (33/1009) bolnikov zdravljenih z risperidonom in 1,2 % (8/712) bolnikov zdravljenih s placebom.
The CHMP assessed the MAH responses and the submitted data, noting that Risperdal Consta was developed for the maintenance treatment of schizophrenia and adopting a harmonised wording that conveys the concept of a therapy to be administered after a disease has been brought under control. 
CHMP je ocenil odgovore in predložene podatke ter izjavil, da je bilo zdravilo Risperdal Consta razvito za vzdrževalno zdravljenje shizofrenije in sprejel usklajeno besedilo, ki odraža terapevtski koncept namenjen uporabi po tem, ko je bolezen ustrezno nadzorovana.
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.
The CHMP considered that the requested efficacy analysis had been provided and that the efficacy of Risperdal Consta was shown in all doses separately. 
CHMP je menil, da je bila zahtevana analiza učinkovitosti predložena ter da je učinkovitost zdravila Risperdal Consta potrjena za vsak odmerek posebej.