natgillin/translations-raw huggingface dataset:
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.
Tap the syringe gently to make any air bubbles rise to the top.
Na injekcijsko brizgo rahlo potrkamo, da se morebitni zračni mehurčki dvignejo na vrh.
When carbamazepine or other CYP 3A4 hepatic enzyme/P-glycoprotein (P-gp) inducers are initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL CONSTA.
Preden začnemo uporabljati ali ukinemo karbamazepin ali druge induktorje jetrnih encimov CYP 3A4/P-glikoproteina (P-gp), je treba odmerek zdravila RISPERDAL CONSTA ponovno oceniti.
The MAH provided further justifications, being of the position that restricting the use of Risperdal Consta to patients with an initial treatment response to oral risperidone would be unjustified and would introduce an unnecessary and potentially prolonged additional step for the prescribing physicians, delaying access of Risperdal Consta to those patients who may not be adherent to their oral medication and who may be among the most suitable candidates for a long-acting injectable medication.
Imetnik dovoljenja za promet z zdravilom je predložil dodatne obrazložitve glede omejevanja uporabe zdravila Risperdal Consta pri bolnikih, pri katerih prvotno zdravljenje s peroralnim risperidonom ni utemeljeno in bi predstavljalo nepotrebno in po možnosti podaljšano fazo za lečečega zdravnika ter s tem odlaganje dostopa do zdravila Risperdal Consta tistim bolnikom, ki jim morda zdravljenje s peroralnim zdravilom ne ustreza in ki so morda med najprimernejšimi kandidati za zdravljenje z dolgo delujočo injekcijo zdravila Risperdal Consta.
Water intoxication Infections and infestations Very common Upper respiratory tract infection Common
Infekcijske in parazitske bolezni Zelo pogosti okužbe zgornjih dihal
The need for increased patient monitoring during the switch period was discussed and the CHMP considered that the data provided showed no worsening in clinical symptoms after the therapy with long-acting risperidone was initiated.
Potekala je tudi razprava o povečanem nadzorovanju bolnikov v času prehajanja iz enega zdravila na drugo in CHMP je menil, da predloženi podatki ne kažejo poslabšanja kliničnih simptomov po pričetku zdravljenja z dolgo delujočim risperidonom.
The following are all the ADRs that were reported in clinical trials and postmarketing.
Navedene neželene učinke so poročali iz kliničnih preskušanj in post-marketinških izkušenj.
The CHMP assessed the data provided on the use of Risperdal Consta in elderly patients and was of the opinion that no significant trend of increased adverse events according to the age of patients or dose of Risperdal Consta were identified.
CHMP je preučil predložene podatke o uporabi zdravila Risperdal Consta pri starejših bolnikih in menil, da se ni pokazalo nobeno povečano pojavljanje neželenih dogodkov glede na starost bolnikov ali na velikost odmerka zdravila Risperdal Consta.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Interaction studies were performed with oral RISPERDAL.
Študije medsebojnega delovanja so se izvajale s peroralnimi oblikami zdravila RISPERDAL.
Medical treatment should be sought straight away if you or your carer notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time.
Če ste opazili oziroma je vaš skrbnik opazil nenadno spremembo v vašem duševnem stanju ali nenadno slabotnost ali otopelost obraza, rok ali nog, posebej na eni strani telesa, nejasen govor, tudi če samo za kratek čas, nemudoma poiščite zdravniško pomoč.
Because Risperdal Consta has not been studied in elderly patients with dementia, it is therefore not indicated for use in this group of patients, as stated in Section 4.4 of the proposed SPC and in line with the current CHMP SPC guideline.
Ker uporaba zdravila Risperdal Consta pri starejših bolnikih z demenco ni bila raziskana, zdravilo za to skupino bolnikov, v skladu z navedbo v poglavju 4.4 predlaganega povzetka glavnih značilnosti zdravila in v skladu s trenutnimi smernicami CHMP glede povzetkov glavnih značilnosti zdravila, ni indicirano.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL or RISPERDAL CONSTA.
Če niste prepričani ali se katero izmed naštetih stanj nanaša na vas, se pogovorite s svojim zdravnikom pred uporabo zdravila RISPERDAL ali RISPERDAL CONSTA.
Close medical supervision and monitoring should continue until the patient recovers.
Do ozdravitve moramo bolnika stalno opazovati in nadzorovati.
Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction.
Fluoksetin in paroksetin, zaviralca CYP 2D6, zvišata koncentracijo risperidona v plazmi, v manjši meri pa koncentracijo aktivne antipsihotične frakcije.
As already mentioned, hypersalivation/ drooling should be added to « EPS » as otherwise incidence of EPS is underestimated.
Hipersialoza/slinjenje naj bo vključeno v „ekstrapiramidne neželene učinke“, saj je drugače pojavnost ekstrapiramidnih neželenih učinkov podcenjena.
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines.
Antipsihotiki lahko v telesu motijo center za sposobnost zniževanja telesne temperature.
Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with a relevant medical history.
Kljub temu, da v kliničnih in epidemioloških študijah še niso dokazali jasne povezave z dajanjem antipsihotikov, je potrebna previdnost pri bolnikih z relevantno zgodovino bolezni.
The mechanism underlying the renal tumours in RISPERDAL CONSTA-treated male Wistar (Hannover) rats is unknown.
Mehanizem nastanka ledvičnih tumorjev pri Wistar (Hannover) podganah, ki so prejemale zdravilo RISPERDAL CONSTA ni poznan.
After a single intramuscular injection with RISPERDAL CONSTA, the release profile consists of a small initial release of risperidone (<1% of the dose), followed by a lag time of 3 weeks.
Profil sproščanja kaže, da se po enkratnem intramuskularnem injiciranju zdravila RISPERDAL CONSTA sprva sprosti majhna količina zdravila (< 1 % celotnega odmerka), nato pa sledi tritedensko obdobje, ko se zdravilo ne sprošča.
Risperidone plus 9-hydroxy-risperidone form the active antipsychotic fraction.
Risperidon skupaj z 9-hidroksi-risperidonom tvori aktivno antipsihotično frakcijo.
Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.
Ostali vplivi na srce, ki so jih poročali pri uporabi antipsihotikov, ki podaljšujejo QT interval so, ventrikularna aritmija, ventrikularna fibrilacija, ventrikularna tahikardija, nenadna smrt, srčni zastoj in Torsades de pointes.
Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Čeprav dosedanje klinične in epidemiološke raziskave niso jasno dokazale povezave z uporabo antipsihotikov, se pri bolnikih z relevantno medicinsko zgodovino priporoča posebna previdnost.
According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy.
Glede na postmarketinške podatke so pri novorojencih žensk, ki so v zadnjem trimesečju nosečnosti jemale risperidon, opazili reverzibilne ekstrapiramidne simptome.
What RISPERDAL CONSTA contains [To be completed nationally]
Kaj vsebuje zdravilo RISPERDAL CONSTA [Poglavje bo dopolnjeno nacionalno]
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Risperdal Consta and associated names (see Annex I).
je CHMP priporočil dopolnilo dovoljenj za promet z zdravilom Risperdal Consta in z njim povezana imena, za katera so v Dodatku III določeni povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo (glejte Dodatek I).
Inject the entire contents of the syringe intramuscularly into the buttock of the patient.
V zadnjico bolnika intramuskularno injiciramo celotno vsebino injekcijske brizge.
Finally, the CHMP discussed the use of Risperdal Consta in patients previously treated with oral risperidone at doses ≥6mg/day and noted that the provided efficacy data of these patients, when switched to Risperdal Consta, were not different from the data obtained after previous oral risperidone treatment, despite the high probability of lower plasma level of risperidone being reached.
CHMP je razpravljal tudi o uporabi zdravila Risperdal Consta pri bolnikih, predhodno zdravljenimi z odmerki peroralnega risperidona ≥6 mg/dan in menil, da se razpoložljivi podatki o učinkovitosti pri teh bolnikih, ko so prešli iz svojega dosedanjega zdravila na zdravilo Risperdal Consta, ne razlikujejo od podatkov pridobljenih po predhodnem zdravljenju s peroralnim risperidonom, ne glede na visoko verjetnost doseganja nižjih ravni plazemske koncentracije risperidona.
• You have liver problems
• če imate težave z jetri
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 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.
For section 4.2, the CHMP discussed the Risperdal Consta starting dose (25 mg, intramuscular, every 2 weeks), considering the data provided by the MAH, and was of the opinion that the recommendation in the SPC that treatment should be started with the dose of 25 mg every two weeks should be maintained.
V poglavju 4.2 je CHMP posebno pozornost namenil začetnemu odmerku zdravila Risperdal Consta (25 mg, intramuskularno, vsaka dva tedna), upoštevajoče predložene podatke imetnika dovoljenja za promet z zdravilom in menil, da je treba obdržati priporočilo v povzetku glavnih značilnosti zdravila, ki pravi, da naj bo začetni odmerek zdravljenja 25 mg vsaka dva tedna.
Each RISPERDAL CONSTA powder and solvent for prolonged-release suspension for injection contains either 12.5 mg, 25 mg, 37.5 mg or 50 mg of risperidone.
RISPERDAL CONSTA prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem vsebuje 12,5 mg, 25 mg, 37,5 mg ali 50 mg risperidona.
When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL CONSTA.
Preden začnemo uporabljati ali ukinemo fluoksetin ali paroksetin je treba odmerek zdravila RISPERDAL CONSTA ponovno oceniti.
Potential for RISPERDAL CONSTA to affect other medicinal products
Možnost vpliva zdravila RISPERDAL CONSTA na delovanje drugih zdravil
PHARMACEUTICAL FORM [To be completed nationally]
FARMACEVTSKA OBLIKA [Poglavje bo dopolnjeno nacionalno]
The CHMP considered the MAH responses and agreed that although data may suggest that prolactin is involved in breast cancer etiology, further studies are required to establish a formal link, and therefore adopted the following wording, addressing the potential risks of hyperprolactinaemia, although without specific inclusion of prolactinoma and breast cancer:
Preučil je tudi odgovore imetnika dovoljenja za promet z zdravilom in soglašal, da čeprav podatki napeljujejo na sklepanje, da je prolaktin vpleten v etiologijo raka dojk, potrebne dodatne študije, ki bodo ustrezno utemeljile dejansko povezavo in zato sprejel naslednje besedilo o možnem tveganju hiperprolaktinemije, vendar brez posebne omembe prolaktinoma in raka dojk.
Risperidone is rapidly distributed.
Risperidon se hitro porazdeli.
Potential for other medicinal products to affect RISPERDAL CONSTA
Možnost vpliva drugih zdravil na delovanje zdravila RISPERDAL CONSTA
• Your doctor may prescribe oral RISPERDAL for the first three weeks following your first injection.
• Zdravnik vam lahko za prve tri tedne po prejemu prve injekcije predpiše zdravilo RISPERDAL v peroralni obliki.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL CONSTA.
Če niste prepričani ali se katero izmed naštetih stanj nanaša na vas, se pogovorite s svojim zdravnikom pred uporabo zdravila RISPERDAL CONSTA.
Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone.
Verapamil, zaviralec CYP 3A4 in P-gp, zviša koncentracijo risperidona v plazmi.
This medicinal product is authorised in the Member States of the EEA under the following names:
V državah članicah EEA je zdravilo registrirano pod naslednjimi imeni: [Poglavje bo dopolnjeno nacionalno]
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (Pack with ALARIS and separate storage for solvent)
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla (pakiranje ALARIS in ločeno shranjevanje topila)
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.
In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk.
Raziskave na živalih so pokazale, da se risperidon in 9-hidroksi-risperidon izločata v mleko.
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.
A treatment-related increase in renal tumour incidence did not occur in the oral carcinogenicity studies with Wistar (Wiga) rats or in Swiss mice administered oral risperidone.
Z zdravljenjem povezano večje tveganje za nastanek ledvičnih tumorjev se ni pokazalo v študijah kancerogenosti s peroralnimi oblikami zdravila Risperdal na Wistar (Wiga) podganah ali na Švicarskih miših.
Hepatic and renal impairment RISPERDAL CONSTA has not been studied in hepatically and renally impaired patients.
Ledvična in jetrna okvara Zdravila RISPERDAL CONSTA niso proučevali pri bolnikih z ledvično in jetrno okvaro.
Belgium Janssen Cilag N.V. Roderveldlaan 1, 2600 Berchem, Belgium
Roderveldlaan 1, 2600 Berchem, Belgija
Smartinska cesta 53, 1000 Ljubljana, Slovenia
Šmartinska cesta 53, 1000
Maintenance dose
Vzdrževani odmerek
“Risperdal Consta is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics”.
„Zdravilo Risperdal Consta je indicirano za vzdrževalno zdravljenje shizofrenije pri bolnikih, trenutno stabiliziranih z peroralnimi antipsihotiki.“
• Eye discharge, eye rolling, eye swelling, ringing in the ears, nose bleeding, dry eye, increased tears, painful oversensitivity to light, increased pressure within the eyeball, reduced visual clarity
• izcedek iz očesa, zavijanje oči, otekanje oči, zvenenje v ušesih, krvavitve iz nosu, suho oko, povečano solzenje, preobčutljivost za svetlobo, povišan pritisk v očesu, zmanjšana ostrina vida
Risperdal should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possibly prolactin-dependent tumours.”
Zdravilo Risperdal naj se uporablja s posebno previdnostjo pri bolnikih s predhodno hiperprolaktinemijo in pri bolniki z tumorji, katerih nastanek je morda povezan s prolaktinom.“
• Nervousness, poor attention, feeling very sleepy, exhausted, or weary, excessive sleep, elated mood (mania), feeling ‘out of sorts', sluggishness
• razdražljivost, slabša pozornost, huda zaspanost, izčrpanost ali potrtost, prekomerno spanje, stanje vznesenosti (manija), slaba volja, počasnost
Body temperature increased, Eosinophil count increased, White blood cell count decreased, Haemoglobin decreased, Blood creatine phosphokinase increased, Body temperature decreased
Zvišana telesna temperatura, zvišano število eozinofilcev, znižano število belih krvničk, znižan hemoglobin, zvišana koncentracija kreatin fosfokinaze v krvi, znižana telesna temperatura
As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e.g., class Ia antiarrhythmics (e.g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e.g., amiodarone, sotalol), tricyclic antidepressants (i.e., amitriptyline), tetracyclic antidepressant (i.e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i.e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone.
Enako, kor pri ostalih antipsihotikih, je potrebna previdnost pri predpisovanju zdravil, ki podaljšujejo QT interval npr. antiaritmiki skupine Ia (kinidin, dizopiramid, prokainamid) in antiaritmiki skupine III (amiodaron, sotalol), triciklični antidepresivi (amitriptilin), tetraciklični antidepresivi (maprotilin), nekateri antihistaminiki, drugi antipsihotiki, nekatera zdravila za zdravljenje malarije (kininu sorodne učinkovine in meflokin) in zdravila, ki povzročajo motnje v ravnovesju elektrolitov (hipokaliemija, hipomagneziemija), bradikardijo ali zdravili, ki zavirajo presnovo risperidona v jetrih.
While overdose is less likely to occur with parenteral than with oral medicinal products, information pertaining to oral is presented.
Ker je verjetnost za prekomerni odmerek pri parenteralni uporabi manjša kot pri peroralni, navajamo ugotovitve, ki veljajo za peroralno uporabo.
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.
V študijah kancerogenosti z zdravilom RISPERDAL CONSTA na Wistar (Hannover) podganah, ki so intramuskularno vsaka dva tedna dobivale 5 oz. 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.
Priapism Psychiatric disorders Very common Depression, Insomnia, Anxiety Common
Psihiatrične motnje Zelo pogosti depresija, nespečnost, tesnoba
“Risperdal Consta should not be used in acute exacerbations of schizophrenia without ensuring sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic during the threeweek lag period following the first Risperdal Consta injection.”
„Zdravilo Risperdal Consta naj se ne uporablja pri akutnih eksacerbacijah shizofrenije brez ustrezne zagotovitve antipsihotičnega kritja s peroralnim risperidonom ali predhodnim antipsihotikom v času tritedenskega obdobja prilagajanja po prvem injiciranju zdravila Risperdal Consta.“
The CHMP assessed the need for a warning, advising against the use of Risperdal Consta in acute exacerbations of schizophrenia, but considered it to potentially raise a safety concern that is not valid or clinically justified and that there are no particular risks associated with using Risperdal Consta in acute exacerbations of schizophrenia that warrant a warning.
CHMP je ocenil potrebo po opozorilu, ki opozarja pred uporabo zdravila Risperdal Consta v primeru akutnih eksacerbacij shizofrenije, saj meni, da lahko takšna navedba poraja nepotrebne in klinično neupravičene varnostne zadržke, saj dejansko ne obstaja nobeno posebno tveganje povezano z uporabo zdravila Risperdal Consta pri akutnih eksacerbacijah shizofrenije, ki bi zahtevali dodatno opozorilo.
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
VIALE PO PRIPRAVI NE SHRANJUJEMO, SAJ SE LAHKO V SUSPENZIJI POJAVIJO USEDLINE.
• Gait disturbance, edema, body temperature increased, drug allergy, speech disorder, movement disorder
• motnje hoje, edem, povišana telesna temperatura, alergija na zdravilo, motnje govora, motnje gibanja
Starting dose:
Začetni odmerek:
Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including oral RISPERDAL.
Pri starejši bolniki z demenco, ki se zdravijo z atipičnimi antipsihotiki, so v meta-analizi 17 nadzorovanih preskušanj z atipičnimi antipsihotičnimi zdravili, vključno s peroralno obliko zdravila RISPERDAL, ugotovili povečano pojavnost smrtnosti v primerjavi s placebom.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally] OTHER [To be completed nationally]
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT [Poglavje bo dopolnjeno nacionalno] DRUGI PODATKI [Poglavje bo dopolnjeno nacionalno]
• Phenothiazines (e.g. used to treat psychosis or to calm down)
• fenotiazini (zdravila, ki se uporabljajo za zdravljenje psihoz ali kot pomirjevala)
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%.
CONSTA, so bila nihanja telesne mase ±7 % od začetne vrednosti; 25 % bolnikom se je telesna masa povečala za ≥ 7 %.
These tumours observed upon oral and intramuscular dosing can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
Ti tumorji, opaženi po peroralem in intramuskularnem dajanju, so lahko povezani z dolgotrajnejšim antagonističnim delovanjem na dopaminske receptorje D2 in s hiperprolaktinemijo.
• One prefilled syringe containing 2 ml solvent for RISPERDAL CONSTA
• Ena napolnjena injekcijska brizga, ki vsebuje 2 ml vehikla za RISPERDAL CONSTA.
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.
Iz navpično postavljene viale počasi povlečemo suspenzijo, kot kaže slika, s čimer zagotovimo, da v injekcijsko brizgo preide celotna vsebina viale.