FrancophonIA/ELRC3.0 huggingface dataset:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally] OTHER [To be completed nationally]
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT [Poglavje bo dopolnjeno nacionalno] DRUGI PODATKI [Poglavje bo dopolnjeno nacionalno]
English: • Phenothiazines (e.g. used to treat psychosis or to calm down)
Slovenian: • fenotiazini (zdravila, ki se uporabljajo za zdravljenje psihoz ali kot pomirjevala)
English: In the 1-year, open-label study of RISPERDAL CONSTA, changes in body weight in individual patients were generally within ±7% from baseline; 25% of patients had an increase in body weight of ≥ 7%.
Slovenian: CONSTA, so bila nihanja telesne mase ±7 % od začetne vrednosti; 25 % bolnikom se je telesna masa povečala za ≥ 7 %.
English: These tumours observed upon oral and intramuscular dosing can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
Slovenian: Ti tumorji, opaženi po peroralem in intramuskularnem dajanju, so lahko povezani z dolgotrajnejšim antagonističnim delovanjem na dopaminske receptorje D2 in s hiperprolaktinemijo.
English: • One prefilled syringe containing 2 ml solvent for RISPERDAL CONSTA
Slovenian: • Ena napolnjena injekcijska brizga, ki vsebuje 2 ml vehikla za RISPERDAL CONSTA.
English: Slowly withdraw the suspension from the vial in an upright, but slightly angled position as indicated in the picture to ensure that the entire contents are drawn up into the syringe.
Slovenian: Iz navpično postavljene viale počasi povlečemo suspenzijo, kot kaže slika, s čimer zagotovimo, da v injekcijsko brizgo preide celotna vsebina viale.
English: • Tonsillitis, eye infection, skin infection, fungal infection of nails
Slovenian: • vnetje tonzil (mandeljnov), okužba oči, okužba kože, glivične okužbe nohtov
English: Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
Slovenian: Eritromicin, zaviralec CYP 3A4, ne vpliva na farmakokinetiko risperidona in aktivne antipsihotične frakcije.
English: It was considered shown that it is not mandatory for patients to have been stabilised on oral medications, and even preferable that patients be switched to the long-acting injectable Risperdal Consta treatment, to increase adherence to the treatment.
Slovenian: Pokazalo se je, da predhodna stabilizacija bolnikov s peroralnimi zdravili ni nujna in da je morda celo bolje, če se zdravljenje prične z dolgo delujočim injiciranim odmerkom zdravila Risperdal Consta za boljše sprejemanje zdravljenja.
English: RISPERDAL CONSTA should be administered every two weeks by deep intramuscular gluteal injection using the enclosed safety needle.
Slovenian: Zdravilo RISPERDAL CONSTA dajemo vsaka dva tedna z intramuskularno injekcijo globoko v zadnjično mišico, pri čemer uporabimo priloženo varnostno iglo.
English: Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.
Slovenian: Zaradi povečanega tveganja za pojav sedacije je treba risperidon v kombinaciji z drugimi zdravili, ki delujejo na osrednji živčni sistem vključno z alkoholom, opioidi, antihistaminiki in benzodiazepini uporabljati previdno.
English: Latvia:
Slovenian: Latvija:
English: Electrocardiogram QT prolonged
Slovenian: Občasni podaljšan QT interval na elektrokardiogramu
English: It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk in small quantities.
Slovenian: Dokazano je bilo, da se risperidon in 9-hidroksi-risperidon v manjših količinah izločata tudi v materino mleko pri človeku.
English: “It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast-milk in small quantities.
Slovenian: „Dokazano je bilo, da se risperidon in 9-hidroksi-risperidon v majhnih količinah izločata tudi v materino mleko.
English: Unresponsive to stimuli, Loss of consciousness, Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular accident, Depressed level of consciousness, Cerebral ischemia, Cerebrovascular disorder, Transient ischemic attack, Dysarthria, Disturbance in attention, Balance disorder, Speech disorder, Coordination abnormal, Movement disorder Eye Disorders
Slovenian: Nedovzetnost za dražljaje, izguba zavesti, nevroleptični maligni sindrom, diabetična koma, cerebrovaskularni dogodki, potlačen nivo zavesti, cerebralna ishemija, cerebrovaskularne motnje, tranzitorna ishemična ataka, disartrija, motnje pozornosti, motnje ravnotežja, motnje govora, motnje koordinacije, motnje pri gibanju
English: Mean in total PANSS score over time (LOCF) in patients with schizophrenia.
Slovenian: Povprečje v celotnem rezultatu PANSS (Positive and negative Syndrome Scale) v času (LOCF-Last Observation Carried Forward) pri bolnikih s shizofrenijo.
English: affects less than 1 user in 10,000
Slovenian: pojavijo se pri manj kot 1 uporabniku na vsakih 10.000
English: affects more than 1 user in 10
Slovenian: pojavijo se pri več kot 1 uporabniku na vsakih 10
English: • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle-with needle protection device).
Slovenian: • Eno iglo Needle-Pro za intramuskulano injiciranje (varnostna igla 20G 2”TW s pripomočkom, ki ščiti iglo).
English: If your daily dose of oral (e.g. tablets) risperidone was more than 4 mg for the last two weeks, you may be given 37.5 mg RISPERDAL CONSTA as a starting dose.
Slovenian: Če je bil zadnja dva tedna vaš dnevni odmerek risperidona v peroralni obliki (npr. tablet) več kot 4 mg, lahko dobite začetni odmerek zdravila RISPERDAL CONSTA 37,5 mg.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA SPREMEMBO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex).
Slovenian: Parkinsonizem vključuje: povečano izločanje sline, mišično-kostno okorelost, slinjenje, nehotene gibe, počasno, zmanjšano ali moteno gibanje telesa, brezizraznost obraza, zategle mišice, okorelost vratu, okorelost mišic, kratke, negotove, hitre korake in odsotnost normalnega gibanja rok pri hoji, dolgotrajno mežikanje zaradi udarjanja z roko ob čelo (nenormalen refleks).
English: In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with RISPERDAL compared with patients treated with placebo (mean age 85 years; range 73 to 97).
Slovenian: V kliničnih preskušanjih nadzorovanih s placebom pri starejših bolnikih z demenco so, pri bolnikih, ki so prejemali zdravilo RISPERDAL, ugotovili značilno višjo pojavnost cerebrovaskularnih neželenih dogodkov (približno 3-kratno povišanje), kot je možganska kap (tudi smrtna) in prehodnih ishemičnih napadov, kot pri bolnikih, ki so prejemali placebo (povprečna starost: 85 let, območje 73-97).
English: RISPERDAL CONSTA taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia.
Slovenian: Pri starejših ljudeh z demenco lahko jemanje zdravila RISPERDAL CONSTA samega ali v kombinaciji s furosemidom, poveča tveganje za možgansko kap ali smrt.
English: • Mishandle the needle protection device that could lead to protrusion of the needle from it.
Slovenian: • neprevidno ravnati s pripravo za zaščito injekcijske igle, saj lahko igla pomoli iz njega.
English: Mania, Libido decreased, Nervousness a Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea.
Slovenian: Hiperprolaktinemija lahko v nekaterih primerih vodi do ginekomastije, motnje menstruacije, amenoreje in galaktoreje.
English: If your daily dose of oral (e.g. tablets) risperidone was 4 mg or less for the last two weeks, your starting dose should be 25 mg RISPERDAL CONSTA.
Slovenian: Če je bil zadnja dva tedna vaš dnevni odmerek risperidona v peroralni obliki (npr. tablet) 4 mg ali manj, je vaš začetni odmerek zdravila RISPERDAL CONSTA 25 mg.
English: Poland:
Slovenian: Poljska:
English: Bundle branch block, Atrial fibrillation, Bradycardia, Sinus bradycardia, Palpitations Blood and lymphatic system disorders Common
Slovenian: Občasni kračni blok, atrijska fibrilacija, bradikardija, sinusna bradikardija, palpitacije Bolezni krvi in limfatičnega sistema
English: The relevance of the osteodystrophy, the prolactin-mediated tumours and of the presumed rat substrain-specific renal tumours in terms of human risk is unknown.
Slovenian: Pomen osteodistrofije, nastanka tumorjev odvisnih od prolaktina in ledvičnih tumorjev, ki so domnevno povezani z vrsto podgan, za varnost ljudi ni znan.
English: In patients with clinical factors such as hepatic or renal impairment or certain drug interactions that increase risperidone plasma concentrations (see section 4.5), dose reduction as low as 12.5 mg may be appropriate.
Slovenian: Pri bolnikih z ledvično in jetrno okvaro in bolnikih, ki jemljejo zdravila, ki povečujejo plazemsko koncentracijo risperidona (glejte poglavje 4.5), je primerno znižanje odmerka na 12,5 mg.
English: • Skin discoloration, skin lesion, skin disorder, thickening of the skin
Slovenian: • razbarvanje kože, razjede na koži, problematična koža, odebelitev kože
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally] OTHER Keep prefilled syringe in the outer carton
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT [Poglavje bo dopolnjeno nacionalno] DRUGI PODATKI Shranjujte injekcijske brizge v zunanji ovojnini.
English: As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.
Slovenian: Kot pri drugih antipsihotikih, tudi pri risperidonu velja previdnost, če se predpisuje bolnikom z znano kardiovaskularno boleznijo, bolnikom s prirojenim sindromom podaljšanega QT intervala, bradikardijo ali neravnovesjem elektrolitov (hipokaliemija, hipomagneziemija), kar lahko poveča tveganje za aritmični efekt in v kombinaciji z zdravili, ki podaljšujejo QT interval.
English: 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]
Slovenian: 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]
English: Vilnius, Lithuania
Slovenian: Ljubljana, Slovenia
English: RISPERDAL CONSTA administration to male and female rats for 12 and 24 months produced osteodystrophy at a dose of 40 mg/kg/2 weeks.
Slovenian: Pri injiciranju zdravila RISPERDAL CONSTA podganjim samcem in samicam 12 in 24 mesecev se je pojavila osteodistrofija pri odmerku 40 mg/kg/2 tedna.
English: Flip off the plastic coloured cap from the vial.
Slovenian: Z viale odstranimo barvno plastično zaporko.
English: The effect of this dose adjustment should not be anticipated earlier than 3 weeks after the first injection with the higher dose.
Slovenian: Pričakovani učinek zdravila na bolnikov klinični status se bo pokazal šele tri tedne po prvem injiciranju večjega odmerka.
English: • The usual dose is 25 mg every two weeks as an injection
Slovenian: • Priporočen odmerek znaša 25 mg vsaka dva tedna, v obliki injekcije.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for prolonged-release suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
English: Electrocardiogram abnormal, Blood prolactin increaseda, Blood glucose increased, Hepatic enzyme increased, Transaminases increased, Gamma-glutamyltransferase increased, Weight increased, Weight decreased
Slovenian: Pogosti nenormalni elektrokardiogram, zvišan prolaktin v krvi a, zvišana glukoza v krvi, zvišanje jetrnih encimov, zvišana koncentracija transaminaz, zvišana gama glutamiltransferaza, povečanje telesne mase, zmanjšanje telesne mase
English: Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.
Slovenian: Galantamin in donepezil ne kažeta klinično pomembnega vpliva na farmakokinetiko risperidona in aktivne antipsihotične frakcije.
English: Appropriate care is advised when prescribing RISPERDAL CONSTA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.
Slovenian: Kadar se zdravilo RISPERDAL CONSTA predpisuje bolnikom s stanji, ki lahko prispevajo k zvišanju telesne temperature npr. intenzivna telesna vadba, izpostavljenost močni toploti, sočasno zdravljenje z antiholinergičnimi zdravili ali dehidracija, je potrebna posebna previdnost.
English: RISPERDAL CONSTA clinical data in elderly are limited.
Slovenian: Klinični podatki o uporabi zdravila RISPERDAL CONSTA pri starejših ljudeh so omejeni.
English: Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.
Slovenian: Amitriptilin ne vpliva na farmakokinetiko risperidona ali aktivne antipsihotične frakcije.
English: Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics.
Slovenian: Pri uporabi antipsihotikov so poročali tudi o pojavu nevroleptičnega malignega sindroma s hipertermijo, rigidnostjo mišic, avtonomno nestabilnostjo, moteno zavestjo in zvišano koncentracijo serumske kreatin fosfokinaze.
English: Not known
Slovenian: Neznana priapizem
English: • Bed wetting, difficulty in urination, urination at short intervals, vaginal discharge
Slovenian: • mokrenje postelje, težave pri uriniranju, uriniranje v kratkih intervalih, izcedek iz nožnice
English: • If you are allergic (hypersensitive) to risperidone or any of the other ingredients of
Slovenian: • če ste alergični (preobčutljivi) na risperidon ali katerokoli sestavino zdravila RISPERDAL CONSTA
English: • Medicines that cause low blood potassium (e.g. certain diuretics)
Slovenian: • zdravila, ki znižajo koncentracijo kalija v krvi (nekateri diuretiki)
English: There are no adequate data from the use of risperidone in pregnant women.
Slovenian: O varnosti uporabe risperidona v času nosečnosti pri ženskah ni dovolj podatkov.
English: RISPERDAL CONSTA is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Slovenian: Zdravilo RISPERDAL CONSTA je indicirano za vzdrževalno zdravljenje shizofrenije pri bolnikih, ki se trenutno zdravijo z antipsihotiki v peroralni obliki.
English: • Discomfort, chills, arm or leg coldness, drug withdrawal syndrome.
Slovenian: • nemir, mrazenje, hladne roke ali noge, odtegnitveni sindrom.
English: Mixing is complete when the suspension appears uniform, thick, and milky in color and all the powder is fully dispersed.
Slovenian: Mešanje je končano, ko suspenzija postane enotna, gosta in mlečne barve, ves prašek pa se popolnoma porazdeli.
English: • Abnormal heart rhythm, awareness of heart beating, slow beating heart,
Slovenian: • nepravilno bitje srca, občutek razbijanja srca, počasnejše bitje srca
English: INFORMATION IN BRAILLE [To be completed nationally]
Slovenian: PODATKI V BRAILLOVI PISAVI [Poglavje bo dopolnjeno nacionalno]
English: RESUSPENSION OF RISPERDAL CONSTA WILL BE NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
Slovenian: PRED UPORABO BO TREBA PONOVNO PRETRESTI SUSPENZIJO ZDRAVILA RISPERDAL CONSTA SAJ SE PO KONČANI PRIPRAVI DELCI SČASOMA ZAČNEJO USEDATI.
English: Additional Adverse Drug Reactions Reported With Oral RISPERDAL but not With RISPERDAL CONSTA by System Organ Class Investigations
Slovenian: Neželeni učinki, ki so jih poročali pri uporabi zdravila RISPERDAL v peroralni obliki, ne pa pri uporabi zdravila RISPERDAL CONSTA, razvrščeni po organskih sistemih Preiskave
English: Where patients are not currently taking oral risperidone, the recommended dose is 25 mg RISPERDAL CONSTA every two weeks.
Slovenian: Če bolniki trenutno ne jemljejo peroralne oblike risperidona, je priporočeni odmerek zdravila RISPERDAL CONSTA 25 mg vsaka dva tedna.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre filled Syringe (all packs)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Napolnjena injekcijaska brizga (vsa pakiranja)
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Poglavje bo dopolnjeno nacionalno]
English: Convulsion, Syncope, Dizziness postural, Hypoaesthesia, Paraesthesia, Lethargy, Hypersomnia
Slovenian: Občasni krči, sinkopa, položajna vrtoglavica, hipoestezija, parestezije, letargija, hipersomnija
English: Pneumonia, Influenza, Lower respiratory tract infection, Bronchitis, Urinary tract infection, Ear infection, Sinusitis, Viral infection
Slovenian: Pogosti pljučnica, gripa, okužbe spodnjih dihal, bronhitis, okužbe urinarnega trakta, ušesne okužbe, vnetje sinusov, virusne infekcije
English: • One Alaris SmartSite needle-free vial access device for reconstitution
Slovenian: • En ALARIS SmartSite pripomoček za rekonstitucijo.
English: If an oral total daily dose of at least 2 mg is well tolerated, an injection of 25 mg RISPERDAL CONSTA can be administered every 2 weeks.
Slovenian: Če bolniki peroralni odmerek, ki ni manjši od 2 mg dnevno, dobro prenašajo, se jim lahko vsaka dva tedna injicira 25 mg zdravila Risperdal Consta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Poglavje bo dopolnjeno nacionalno]
English: • Weight increased, toothache, weight decreased
Slovenian: • povečana telesna masa, zobobol, zmanjšana telesna masa
English: • Abnormal posture, joint stiffness, neck pain, breakdown of muscle and pain in muscles
Slovenian: • nenormalna telesna drža, okorelost sklepov, bolečine v vratu, mišična oslabelost in bolečine v mišicah
English: • You are diabetic
Slovenian: • če ste sladkorni bolnik
English: “Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Slovenian: „Študije kultur tkiv nakazujejo, da prolaktin morda stimulira rast celic v tumorjih dojk pri ljudeh.
English: • Inability to sleep, anxiety, depression, irritability, feeling of inner restlessness
Slovenian: • motnje spanja, tesnoba, depresija, razdražljivost, občutek notranje neumornosti
English: Cases of abnormal electrical conduction in the heart and convulsion have been reported
Slovenian: Poročali so o motnjah prevajanja v srcu in krčih.
English: Seizures
Slovenian: Zardevanje
English: United Kingdom
Slovenian: Zdruzeno kraljestvo (Velika Britanija)
English: b Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal), akathisia (akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia.
Slovenian: Lahko se pojavijo ekstrapiramidne motnje: parkinsonizem (povečano izločanje sline, muskuloskeletna togost, parkinsonizem, slinjenje, okorelost po tipu zobatega kolesa, bradikinezija, hipokinezija, obraz maske, mišična napetost, akinezija, okorel vrat, rigidnost mišic, parkinsonska drža in nenormalni glabelarni refleks), akatizija (akatizija, vznemirjenost, hiperkinezija in sindrom nemirnih nog), tremor, diskinezija (diskinezija, trzanje mišic, horeoatetoza, atetoza, in mioklonus), distonija.
English: The CHMP further assessed data from patients switched to Risperdal Consta without stabilisation on oral risperidone, and concluded that sufficient antipsychotic coverage should be ensured during a lag period following the first Risperdal Consta injection.
Slovenian: Odbor za zdravila za uporabo v humani medicini je prav tako preučil podatke bolnikov, ki so pričeli z zdravljenjem z zdravilom Risperdal Consta brez predhodne stabilizacije s peroralnim risperidonom ter menil, da v obdobju po prvem injiciranju zdravila Risperdal Consta obstaja zadostno antipsihotično kritje kot posledica injiciranega zdravila.
English: There is no specific antidote to RISPERDAL.
Slovenian: Za zdravilo RISPERDAL ni specifičnega antidota, zato moramo uvesti ustrezne podporne ukrepe.
English: RISPERDAL CONSTA is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti, uporaba zdravila RISPERDAL CONSTA pri otrocih in mladostnikih, mlajših od 18 let ni priporočljiva.
English: Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Slovenian: Pri bolnikih s sladkorno boleznijo in bolnikih, z dejavniki tveganja za razvoj sladkorne bolezni, je priporočljivo ustrezno klinično spremljanje.
English: Tinnitus
Slovenian: Tinitus
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (Pack with 3 needle system)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla (pakiranje s tremi iglami)
English: Take special care with RISPERDAL CONSTA
Slovenian: Bodite posebno pozorni pri uporabi zdravila RISPERDAL CONSTA
English: Withdraw the syringe with the reconstitution needle from the vial.
Slovenian: Injekcijsko brizgo z iglo za rekonstitucijo izvlečemo iz viale.
English: Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium
Slovenian: Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgija
English: Press the syringe tip into the vial access device and twist in a clockwise motion to ensure that the syringe is securely attached to the white luer cap of the vial access device.
Slovenian: Konico injekcijske brizge potisnemo v nastavek pripomočka za rekonstitucijo in zasukamo v smeri urinega kazalca, da zagotovimo, da je injekcijska brizga varno pritrjena na belo LUER zaporko nastavka na viali.
English: affects 1 to 10 users in 100
Slovenian: pojavijo se pri 1 do 10 uporabnikov na vsakih 100
English: Janssen-Cilag International NV, Belgium Turnhoutseweg 30, 2340 Beerse, Belgium
Slovenian: Janssen-Cilag International NV, Belgium Turnhoutseweg 30, 2340 Beerse, Belgija
English: Therefore, RISPERDAL CONSTA should not be used during pregnancy unless clearly necessary.
Slovenian: Zato se risperidon med nosečnostjo lahko uporablja le v primeru, da so koristi večje od tveganja.
English: The following is a list of additional ADRs associated with risperidone that have been identified as ADRs during clinical trials investigating the oral risperidone formulation (RISPERDAL) but were not determined to be ADRs in the clinical trials investigating RISPERDAL CONSTA.
Slovenian: V spodnji tabeli so navedeni dodatni neželeni učinki povezani z risperidonom, ki so jih ugotovili med kliničnimi preskušanji s peroralnimi oblikami risperidona (RISPERDAL), ne pa v kliničnih preskušanjih z zdravilom RISPERDAL CONSTA.