FrancophonIA/ELRC3.0 huggingface dataset:
English: Swelling and pain in one part of the body that can be caused by blood clotting within vein Tissue swelling in limbs
Slovenian: Občasni (do njih pride pri manj kot 1 od 100 bolnikov): levkemija (krvni rak) nenadna izguba zavesti oteklina in bolečina v enem delu telesa, do česar lahko pride zaradi krvnega strdka v veni otekanje tkiva v okončinah
English: Very common (affecting more than 1 in 10 patients):
Slovenian: Zelo pogosti (do njih pride pri več kot 1 od 10 bolnikov): izpadanje las bruhanje, ranice v ustih, slabost šibkost
English: Febrile bone marrow aplasia, eosinophil count increased, neutrophil count increased, platelet count increased, white blood cell count increased, lymphocyte count decreased, monocyte count decreased Immune system disorders
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) občasni akutna mieloična levkemija Bolezni krvi in limfatičnega sistema zelo pogosti anemija, levkopenija pogosti nevtropenija, trombocitopenija, febrilna nevtropenija, granulocitopenija občasni febrilna aplazija kostnega mozga, povečano število eozinofilcev, povečano število nevtrofilcev, povečano število trombocitov, povečano število levkocitov, zmanjšano število limfocitov, zmanjšano število monocitov Bolezni imunskega sistema pogostnost neznana anafilaktična reakcija, preobčutljivost Presnovne in prehranske motnje pogosti anoreksija
English: Slight fever
Slovenian: Okvara jeter
English: HOW TO STORE {(Invented) Name} [To be completed nationally]
Slovenian: SHRANJEVANJE ZDRAVILA {LASTNIŠKO IME} [izpolni država članica]
English: Myelosuppressive effects that may be additive to those of chemotherapy were reported with {(Invented) Name} (see section 4.8).
Slovenian: Pri uporabi zdravila {(Lastniško) ime} so poročali o možnosti aditivnega mielosupresivnega delovanja s kemoterapijo (glejte poglavje 4.8).
English: Gastrointestinal disorders Very common Nausea, vomiting, stomatitis Common
Slovenian: Žilne bolezni pogosti flebitis občasni venska tromboza, limfedem pogostnost neznana embolija
English: Diarrhoea, stomach pain, constipation, fullness in stomach and loss of appetite Decreased heart muscle function, fast heart beat
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja, kašelj, faringitis občasni okužba dihal pogostnost neznana pljučna embolija
English: Liver dysfunction was occasionally observed in patients treated with {(Invented) Name} (see section
Slovenian: Pri bolnikih, ki so prejemali zdravilo {(Lastniško) ime}, so občasno opažali nepravilno delovanje jeter (glejte poglavje 4.8).
English: Vertigo, ear infection
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni vrtoglavica, okužba ušesa
English: The carcinogenic potential of dexrazoxane has not been investigated.
Slovenian: vendar potrebujejo nadaljnje zdravljenje z antraciklini.
English: The volume of distribution is 1-2 l/kg.
Slovenian: Volumen porazdelitve je 1-2 l/kg.
English: There was no evidence of genotoxic potential.
Slovenian: Ni bilo dokazov o genotoksičnem potencialu.
English: The remainder is inactive metabolites.
Slovenian: Ostalo je neaktivni metabolit.
English: Consequently, newborns should be monitored carefully.
Slovenian: Zato je treba novorojence skrbno spremljati.
English: • You are a man and have ever had a prolonged or painful erection.
Slovenian: • če ste moški in ste kdaj imeli podaljšano ali bolečo erekcijo.
English: This was supported by results from the switching studies and since this product has been on the market for several years already, its efficacy and safety have been already confirmed.
Slovenian: To so potrdili tudi rezultati študij o zamenjavi zdravila in glede na to, da je zdravilo na tržišču že kar nekaj let, sta bili tudi učinkovitost in varnost že potrjeni.
English: Each individual symptom may occur less frequently than in 1 in 10 people.
Slovenian: Vsak posamezni simptom se lahko pojavi redkeje kot pri 1 na vsakih 10 ljudi.
English: Cologno Monzese, 20093, Milano, Italy
Slovenian: Cologno Monzese, 20093, Milano, Italija
English: If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Slovenian: Če je ta kombinacija, posebno v končnem stadiju Parkinsonove bolezni, potrebna je treba predpisati najnižji učinkoviti odmerek vsakega zdravila.
English: • Prolonged and painful erection
Slovenian: • podaljšana in boleča erekcija
English: Biotransformation and elimination
Slovenian: Biotransformacija in eliminacija
English: Immediate medical treatment may be needed.
Slovenian: Potrebna je takojšnja zdravstvena oskrba.
English: Invented Name Strength
Slovenian: Izmišljeno ime Jakost
English: • Dangerously excessive intake of water
Slovenian: • nevarno prekomerno pitje vode
English: • Sudden loss of vision or blindness.
Slovenian: • nenadna izguba vida ali slepota.
English: Do not administer intravenously (see section 4.4 and section 6.6).
Slovenian: Zdravila ne dajemo intravensko (glejte poglavje 4.4 in poglavje 6.6).
English: Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Slovenian: Zato je treba bolnikom svetovati, da ne vozijo vozil ali upravljajo strojev, dokler se ne ugotovi njihove občutljivosti na zdravilo.
English: 192 07 Sollentuna Sweden
Slovenian: 192 07 Sollentuna Švedska
English: • Trouble breathing during sleep
Slovenian: • težko dihanje med spanjem
English: It is especially important to talk to your doctor or pharmacist if you are taking any of the following:
Slovenian: Posebej pomembno je, da se pogovorite z zdravnikom ali s farmacevtom, če jemljete kaj od navedenega:
English: Neuroleptic malignant syndrome (NMS)
Slovenian: Nevroleptični maligni sindrom (NMS)
English: Gender, race and smoking habits
Slovenian: Spol, rasa in kajenje
English: The following terms and frequencies are applied: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 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 clinical trial data).
Slovenian: Uporabljajo se naslednji izrazi in pogostnosti: zelo pogosti (≥1/10); pogosti (≥1/100, <1/10); občasni (≥1/1.000, <1/100); redki (≥1/10.000, <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: • Decreased appetite, increased appetite
Slovenian: • zmanjšan apetit, povečan apetit
English: 41470 Neuss
Slovenian: 41470 Neuss Nemčija
English: • You have epilepsy
Slovenian: • če imate epilepsijo
English: Concomitant use with furosemide
Slovenian: Sočasna uporaba s furosemidom
English: You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
Slovenian: Z jemanjem tega zdravila ne prenehajte, če vam tega ni predpisal vaš zdravnik, ker se simptomi vaše bolezni lahko ponovijo.
English: Janssen Farmacêutica Portugal Lda.
Slovenian: Portugalska Janssen Farmacêutica Portugal Lda.
English: Tremor includes tremor and parkinsonian rest tremor.
Slovenian: Tremor vključuje tremor in parkinsonski tremor v mirovanju.
English: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Slovenian: Vzpostavimo in vzdržujemo proste dihalne poti ter zagotovimo primerno oksigenacijo in ventilacijo.
English: Janssen-Cilag AB c/oVistor hf.Hörgatúni 2 Garðabær, Iceland
Slovenian: Janssen-Cilag AB c/oVistor hf.Hörgatúni 2 Garðabær, Islandija
English: Pharmacotherapeutic group: Other antipsychotics, ATC code: N05AX08
Slovenian: Farmakoterapevtska skupina: drugi antipsihotiki; ATC koda: N05AX08.
English: Pharmaceutical Form Route of administration Content (concentration)
Slovenian: Farmacevtska oblika Pot uporabe zdravila vsebina (koncentracija)
English: Unknown frequency of occurrence (frequency cannot be estimated from the available data):
Slovenian: Neznana pogostnost (glede na razpoložljive podatke pogostnosti ne moremo ocenit):
English: Do not substitute any components in the dose pack.
Slovenian: Ne zamenjujte sestavin v škatlici.
English: • Severe allergic reaction resulting in difficulty in breathing and shock
Slovenian: • močna alergijska reakcija s težkim dihanjem in šokom
English: • Medicines for Parkinson's disease (such as levodopa)
Slovenian: • zdravila proti Parkinsonovi bolezni (kot je levodopa)
English: Prepare the patient for injection.
Slovenian: Bolnika pripravimo za injiciranje.
English: • You have a heart problem.
Slovenian: • če imate težave s srcem.
English: Your doctor will decide if you can use it
Slovenian: On se bo odločil ali lahko zdravilo uporabljate.
English: Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Slovenian: Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena
English: This list is indicative and not exhaustive.
Slovenian: Ta seznam je indikativen in ne vsebuje vseh zdravil.
English: It is an effective atypical antipsychotic that is well tolerated, based on extensive clinical experience including long-term use.
Slovenian: Je učinkovit atipični antipsihotik, ki ga na podlagi obsežnih kliničnih izkušenj, tudi ob dolgotrajni uporabi, bolniki dobro prenašajo.
English: Karla Engliše 3201/6, 15000 Praha 5, Czech Republic
Slovenian: Karla Engliše 3201/6, 15000 Praga 5, Češka
English: WARNING: To avoid a needle stick injury with a contaminated needle, do not :
Slovenian: OPOZORILO: Da se izognemo poškodbam s kontaminirano iglo, ne smemo:
English: Furthermore, « Anxiety » and « nervousness » should be separated and not grouped by the term “anxiety”.
Slovenian: Poleg tega je treba ločiti tudi „anksioznost“ in „nervozo“ in ju ne zaobjeti z izrazom „anksioznost“.
English: For section 4.8, the CHMP assessed and harmonised the wording.
Slovenian: V poglavju 4.8 je CHMP preučil in uskladil besedilo.
English: Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents.
Slovenian: Hipotenzijo in cirkulatorni kolaps moramo zdraviti s primernimi ukrepi, kot so intravenske tekočine in/ali simpatikomimetiki.
English: Tardive dyskinesia/extrapyramidal symptoms (TD/EPS)
Slovenian: Tardivna diskinezija/ekstrapiramidni simptomi (TD/EPS)
English: It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.
Slovenian: Naveden je širši nabor simptomov, ki niso nujno ekstrapiramidnega izvora.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar pomeni ‘brez natrija'.
English: There is no evidence to suggest that hypercalcemia might cause phaeochromocytomas in humans.
Slovenian: Ni dokazov, ki bi nakazovali, da hiperkalciemija lahko povzroči feokromocitome pri ljudeh.
English: Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure.
Slovenian: To vključuje neredno bitje srca ali če ste nagnjeni k nizkemu krvnemu tlaku ali jemljete zdravila za krvni tlak.
English: Shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Slovenian: Vialo močno stresamo vsaj 10 sekund dokler ne dobimo homogene suspenzije.
English: • Intentionally disengage the Needle-Pro device
Slovenian: • namenoma odstraniti pripomočka Needle-Pro,
English: The second week 1 mg twice daily or 2 mg once daily can be given.
Slovenian: V drugem tednu zdravljenja lahko dobivajo 1 mg dvakrat dnevno, ali pa 2 mg enkrat dnevno.
English: “Sedation” should be separated from “somnolence” and not grouped by the term “sedation”.
Slovenian: „Sedacija“ naj bo ločena od „somnolence“ in ne zaobjeta z izrazom „sedacija“.
English: CYP 2D6 is subject to genetic polymorphism.
Slovenian: Citokrom CYP 2D6 je podvržen genskemu polimorfizmu.
English: RISPERDAL CONSTA has minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
Slovenian: Zdravilo RISPERDAL CONSTA ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji zaradi možnega vpliva na živčni sistem in vid (glejte poglavje 4.8).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RISPERDAL CONSTA AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA RISPERDAL CONSTA IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - da so bili povzetki glavnih značilnosti zdravila, označevanj in navodil za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, ovrednoteni na podlagi predložene dokumentacije in strokovne razprave v Odboru,
English: DO NOT ADMINISTER INTRAVENOUSLY.
Slovenian: NE APLICIRAJTE INTRAVENSKO.
English: Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
Slovenian: Ne glede na način zdravljenja je dehidracija splošni dejavnik tveganja za smrtnost, zato se ji moramo pri zdravljenju starejših bolnikov z demenco izogniti.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.
Slovenian: Če se pojavijo znaki in simptomi tardivne diskinezije, je potrebno razmisliti o prekinitvi uporabe vseh antipsihotikov.
English: Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child.”
Slovenian: Tako je potrebno preučiti prednosti dojenja v primerjavi z možnimi tveganji za otroka.“
English: The Referral procedure under Article 30 of Directive 2001/83/EC, as amended for Risperdal Consta was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to indications, special warnings and precautions for use and interaction with other medicinal products and other forms of interaction.
Slovenian: Napotitveni postopek za zdravilo Risperdal Consta je bil v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, sprožen za razrešitev neskladij med informacijami o zdravilu med odobrenimi besedili v uporabi v posameznih državah članicah v EU in EGS, zlasti v zvezi s poglavji o indikacijah, posebnih opozorilih in previdnostnih ukrepih ter medsebojnem delovanju z drugimi zdravili in drugimi oblikami interakcij.
English: • See a doctor right away.
Slovenian: • Takoj obiščite svojega zdravnika.
English: frequency cannot be estimated from the available data.
Slovenian: glede na razpoložljive podatke pogostnosti ne moremo oceniti.
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription and herbal medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, vključno z zeliščnimi pripravki.
English: For instructions on preparation and handling RISPERDAL CONSTA, see section 6.6.
Slovenian: Za navodila za pripravo in uporabo zdravila RISPERDAL CONSTA glejte poglavje 6.6.
English: • Rifampicin (a medicine for treating some infections)
Slovenian: • rifampicin (zdravilo za zdravljenje nekaterih okužb)
English: • Yellowing of the skin and the eyes (jaundice)
Slovenian: • porumenelost kože in oči (zlatenica)
English: Aebe Eirinis Avenue 56, Pefki, 15121, Greece suspension for injection
Slovenian: Aebe Eirinis Avenue 56, Pefki, 15121, Grčija suspenzijo za injiciranje
English: • Inappropriate secretion of a hormone that controls urine volume
Slovenian: • nepravilno izločanje hormona, ki uravnava količino urina
English: • You have Parkinson's disease or dementia
Slovenian: • če imate Parkinsonovo bolezen ali demenco
English: • Body shakes rapidly and uncontrollably (convulsion)
Slovenian: • hitro, nenadzorovano tresenje telesa (konvulzije)
English: Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenia
Slovenian: Slovenija Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenija
English: 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.
Slovenian: 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.
English: If you start or stop taking such medicines you may need a different dose of risperidone
Slovenian: Če začnete ali prenehate jemati ta zdravila, boste morda potrebovali drugačen odmerek risperidona.
English: Place vial on a hard surface.
Slovenian: Vialo postavimo na trdno površino.
English: Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
Slovenian: Sočasna uporaba risperidona z drugimi diuretiki (v glavnem s tiazidnimi diuretiki v majhnih odmerkih) ni bila povezana s podobnimi ugotovitvami.
English: • Decrease in white blood cells that help against infection, decrease in platelets (blood cells that help you stop bleeding).
Slovenian: • zmanjšanje števila belih krvnih celic, ki pomagajo pri obrambi proti infekcijam, zmanjšanje števila krvnih ploščic (krvne celice, ki pomagajo zaustaviti krvavitev).
English: Risperidone is a selective monoaminergic antagonist with unique properties.
Slovenian: Risperidon je selektiven monoaminergičen antagonist s svojstvenimi značilnostmi.
English: For section 4.6, the CHMP discussed the wording, moving the mention of galactorrhea to section 4.8 and adopting the following harmonised wording:
Slovenian: V poglavju 4.6 je CHMP preučil besedilo in premaknil omembo galaktoreje v poglavje 4.8 ter sprejel naslednje usklajeno besedilo:
English: The CHMP agreed that no non-inferiority study is required and the following wording for section 4.1 was adopted:
Slovenian: Odbor se je strinjal, da ni potrebe po študiji enakovrednosti in potrdil naslednjo ubeseditev za poglavje 4.1:
English: • Phenobarbital
Slovenian: • fenobarbital
English: JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Spain
Slovenian: JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Španija
English: In overdose, QT-prolongation and convulsions have been reported.
Slovenian: Pri prekomernem odmerjanju so poročali o podaljšanju QT-dobe in konvulzijah.
English: 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.
Slovenian: 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.
English: Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3).
Slovenian: V študijah na živalih risperidon ni bil teratogen, so se pa pokazali ostali vplivi na sposobnost razmnoževanja (glejte poglavje 5.3).
English: For section 4.4, the CHMP implemented the wording on tardive dyskinesia, agreed upon by the Pharmacovigilance Working Party.
Slovenian: V poglavju 4.4 je CHMP sprejel besedilo glede tardivne diskinezije, o katerem se je strinjala tudi delovna skupina za farmakovigilanco.
English: Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway
Slovenian: Norveška Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norveška
English: Anorexia, Polydipsia
Slovenian: Anoreksija, polidipsija
English: The elimination phase is complete approximately 7 to 8 weeks after the last RISPERDAL CONSTA injection.
Slovenian: Faza eliminacije je zaključena približno 7 do 8 tednov po zadnji injekciji zdravila RISPERDAL CONSTA.
English: Risperidone was not teratogenic in rat and rabbit.
Slovenian: Risperidon ni bil teratogen pri podganah in kuncih.
English: Sweden Janssen-Cilag AB Box 7073
Slovenian: Janssen-Cilag AB Box 7073
English: Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Slovenian: Tudi drugi antagonisti dopamina so po dajanju brejim živalim povzročili negativne učinke na učenje in motorični razvoj pri mladičih.
English: 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.
Slovenian: 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.
English: The intramuscular long-acting injection (LAI) formulation provides slow and steady release of risperidone over a period of several weeks.
Slovenian: Pripravek za intramuskularno injekcijo s podaljšanim delovanjem (LAI) zagotavlja počasno in konstantno sproščanje risperidona v obdobju nekaj tednov.
English: For section 4.3, the CHMP discussed the relevance of a Contraindication warning for patients with high risk factors for cerebrovasular adverse events.
Slovenian: V poglavju 4.3 je CHMP preučil pomen opozorila glede kontraindikacij pri bolnikih z visokim faktorjem tveganja za cerebrovaskularne neželene dogodke.
English: • Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants
Slovenian: • antidepresivi, kot so paroksetin, fluoksetin, triciklični antidepresivi
English: • 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.
Slovenian: • imate nenormalno visoko koncentracijo hormona prolaktina v krvi ali imate tumor, ki je odvisen od prolaktina.
English: The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1).
Slovenian: Razmerje verjetnosti (95 % interval zaupanja) je bilo 1,21 (0,7; 2,1).
English: Weight should be measured regularly.
Slovenian: Telesno maso je treba redno spremljati.
English: 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.
Slovenian: CHMP je menil, da se odmerkov risperidona >8mg ne bi smelo rutinsko predpisovati ter da naj bodo omejeni le na določene skupine bolnikov.
English: The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50).
Slovenian: Razmerje verjetnosti (95 % interval zaupanja) je bilo 2,96 (1,34; 7,50).
English: The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
Slovenian: Učinkovitost 12,5 mg odmerka risperidona ni bila dokazana v kliničnih preskušanjih.
English: Very rare side effects (affects less than 1 user in 10,000) may include: • Life-threatening complications of uncontrolled diabetes.
Slovenian: Zelo redki neželeni učinki (pojavijo se pri manj kot 1 uporabniku na vsakih 10.000) • življenjsko nevarni zapleti pri nenadzorovani sladkorni bolezni
English: The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
Slovenian: Povečano smrtnost pri bolnikih, ki so se sočasno zdravili s furosemidom in risperidonom so ugotovili v dveh od opravljenih štirih kliničnih preskušanj.
English: As with other antipsychotics, patients should be advised of the potential for weight gain.
Slovenian: Kot pri drugih antipsihotikih, moramo bolnike opozoriti, da lahko pridobijo na telesni masi.
English: Netherlands Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240
Slovenian: Nizozemska Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240
English: UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilnius, Lithuania
Slovenian: UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilna, Litva