natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address}
IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek 1 - poglavje bo dopolnjeno nacionalno] {Ime in naslov}
• Restlessness, sleep disorder, dizziness, feeling dizzy when staying still, fatigue, drowsiness,
• nemir, motnje spanja, vrtoglavica, občutek omotičnosti v mirovanju, utrujenost, dremavost, zaspanost
There was no relationship between the plasma concentrations of the active antipsychotic fraction and the change in total PANSS (Positive And Negative Syndrome Scale) and total ESRS (Extrapyramidal Symptom Rating Scale) scores across the assessment visits in any of the phase-III trials where efficacy and safety was examined.
V nobenem preskušanju (faza III), v katerem so proučevali varnost in učinkovitost risperidona, niso ugotovili povezave med koncentracijami aktivne antipsihotične frakcije v plazmi in spremembo v skupnem rezultatu na lestvici pozitivnih in negativnih sindromov (PANSS-Positive And Negative Syndrome Scale) ter lestvici ekstrapiramidnih simptomov (ESRS-Extrapyramidal Symptom Rating Scale).
• Bladder infection, stomach and intestine infection, ear pain
• vnetje mehurja, vnetje želodca in črevesja, bolečine v ušesu
With a straight push down movement press the spike tip of the vial access device through the centre of the vial's rubber stopper until the device securely snaps onto the vial top.
Z močnim potiskom navzdol konico pripomočka potisnemo skozi sredino gumijaste zaporke viale, da pripomoček zanesljivo pritrdimo na vrh viale.
Uncommon side effects (affects 1 to 10 users in 1000):
Občasni neželeni učinki (pojavijo se pri 1 do 10 uporabnikov na vsakih 1000):
Do not remove the sheath from the needle at this time.
Tokrat varovalnega tulca ne odstranimo z igle.
RISPERDAL® CONSTA Sweden: RISPERDAL® CONSTA® United Kingdom: RISPERDAL® CONSTA®
RISPERDAL® CONSTA® Zdruzeno kraljestvo (Velika Britanija): RISPERDAL® CONSTA®
Insert the reconstitution needle into the upright vial.
Iglo zabodemo v navpično postavljeno vialo.
Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
Cimetidin in ranitidin povečata biološko uporabnost risperidona ampak samo v mejah aktivne antipsihotične frakcije.
Open the cover of one reconstitution needle.
Odpremo pokrovček na eni izmed igel za rekonstitucijo.
Pó e veículo para suspensão injectável
Prašek in vehikel za suspenzijo za injiciranje
Enuresis, Dysuria, Pollakiuria
Enureza,, disurija, polakiurija
RISPERDAL CONSTA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Previdnost je potrebna pri uporabi zdravila RISPERDAL CONSTA pri bolnikih, ki so v preteklosti že imeli epileptične napade (krče) ali ostala stanja, ki lahko znižujejo prag vzdražnosti za epileptične napade.
Do not take RISPERDAL CONSTA
Ne uporabljajte zdravila RISPERDAL CONSTA
• This medicine has been prescribed for you.
− To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Alternatively, a starting dose of RISPERDAL CONSTA of 12.5 mg may be appropriate.
Pri teh bolnikih bi lahko bil primeren začetni odmerek zdravila Risperdal Consta 12,5 mg.
No osteodystrophy was observed in dogs treated for 12 months with RISPERDAL CONSTA up to 20 mg/kg/2 weeks.
Pri psih, ki so jim dajali zdravilo RISPERDAL CONSTA 12 mesecev do odmerka 20 mg/kg/2 tedna ni prišlo do osteodistrofije.
Atrioventricular block, Tachycardia
Srčne bolezni Pogosti atrioventrikularni blok, tahikardija
Furthermore, the PK of Risperdal Consta in the elderly population was adequately described, and it was shown that the pharmacokinetics in the population > 65 years are comparable to the population < 65 years.
To se odraža tudi v usklajenem besedilu povzetka glavnih značilnosti zdravila, skupaj z izjavo: „Učinkovitost 12,5 mg odmerka ni bila preverjena s kliničnimi preskušanji.“ Poleg tega je ustrezno opisana tudi farmakokinetika zdravila Risperdal Consta pri starejši populaciji, ki kaže, da je farmakokinetika pri populaciji > 65 let primerljiva s farmakokinetiko pri populaciji <65 let.
• No menstruation, erectile dysfunction, breast discharge
• izostanek menstruacije, motnje erekcije, izcedek iz dojk
The combination of the release profile and the dosage regimen (intramuscular injection every two weeks) results in sustained therapeutic plasma concentrations.
Nespremenjene vzdrževalne terapevtske plazemske koncentracije so posledica kombinacije profila sproščanja in režima odmerjanja (intramuskularna injekcija, vsaka dva tedna).
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Na podlagi študij tkivnih kultur sklepajo, da prolaktin lahko vzpodbuja celično rast v človeških tumorjih dojke.
Oral antipsychotic supplementation should therefore be given during the first 3 weeks of RISPERDAL CONSTA treatment (see section 4.2).
Zato morajo bolniki v prvih treh tednih zdravljenja z zdravilom RISPERDAL CONSTA sočasno jemati še dodatna peroralna antipsihotična zdravila (glejte poglavje 4.2).
“For most patients the recommended dose is 25 mg intramuscular every two weeks.
„Za večino bolnikov je priporočen odmerek 25 mg intramuskularno, vsaka dva tedna.
Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Povečana občutljivost na antipsihotična zdravila se poleg ekstrapiramidnih znakov kaže kot zmedenost, otopelost, nesigurnost pri hoji s pogostimi padci.
RISPERDAL CONSTA should be used with caution in elderly.
Pri starejših se mora zdravilo RISPERDAL CONSTA uporabljati previdno.
Remove air bubbles from the syringe barrel by moving the plunger rod forward with the needle in an upright position.
Iz notranjosti brizge odstranimo mehurčke, tako da potiskamo bat naprej (igla naj pri tem stoji navpično).
• If you have never taken any form of RISPERDAL, you should begin with oral RISPERDAL
• če še niste jemali zdravila Risperdal v kakršnikoli obliki morate pred prvim injiciranjem zdravila
Another metabolic pathway of risperidone is N-dealkylation.
Risperidon se presnavlja tudi z N-dealkilacijo.
Where patients are not currently taking oral risperidone, the oral pre-treatment dosage should be considered when choosing the i.m.
Pri bolnikih, ki trenutno ne jemljejo risperidona v peroralni obliki, je treba pred izbiro začetnega intramuskularnega odmerka razmisliti o predhodnem peroralnem dajanju risperidona.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
− Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Patients on higher dosages of the used oral antipsychotic should be considered for the higher Risperdal Consta dose of 37.5 mg.”
Pri bolnikih, ki prejemajo večje odmerke uporabljenega peroralnega antipsihotika, naj se preuči možnost uporabe večjega odmerka, 37,5 mg zdravila Risperdal Consta.“
affects 1 to 10 users in 10,000
pojavijo se pri 1 do 10 uporabnikov na vsakih 10.000
Administration of partial contents may not deliver the intended dose of risperidone.
Uporaba v večih delih ne zagotavlja prejema priporočenega odmerka risperidona.
affects 1 to 10 users in 1,000
pojavijo se pri 1 do 10 uporabnikov na vsakih 1000
LIST OF EXCIPIENTS [To be completed nationally] PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for prolonged-release suspension for injection.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN [Poglavje bo dopolnjeno nacionalno] SEZNAM POMOŽNIH SNOVI [Poglavje bo dopolnjeno nacionalno] FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem.
If you cannot keep your appointment, be sure to contact your doctor right away to discuss another date when you can come in for your injection.
Če tisti dan ne utegnete se z zdravnikom dogovorita za kakšen drug dan.
stomach infection
Žilne bolezni
• Tremor, muscle weakness, fall, back pain, muscle spasm, pain in arms and legs, joint pain,
• tremor, mišična oslabelost, padci, bolečine v hrbtu, mišični krči, bolečine v rokah in nogah, bolečine v sklepih, nehoteni gibi obraznih mišic ali mišic udov, bolečine v mišicah, otekanje rok in nog
Respiratory, Thoracic, and Mediastinal Disorders Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Epistaxis, Respiratory tract congestion, Hyperventilation, Dysphonia Gastrointestinal Disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Sopenje, aspiracijska pljučnica, pljučna kongestija, respiratorne motnje, žvižgi v pljučih, epistaksa, kongestija dihal, hiperventilacija, hripavost
RISPERDAL CONSTA should be used with caution in patients with risk factors for stroke.
Pri bolnikih s tveganjem za kap, je treba RISPERDAL CONSTA uporabljati previdno.
• Wheezing, pneumonia caused by inhaling food, hoarseness, cough with sputum, lung congestion, breathing passage congestion, crackly lung noise, breathing passage disorder, fast shallow breathing
• sopenje, aspiracijska pljučnica, povzročena z vdihnjeno hrano, hripavost, produktivni kašelj, zapora pljuč, zapora dihalnih poti, piskanje v pljučih, motnje dihalnih poti, hitro plitvo dihanje
• Inflammation of the pancreas.
• vnetje trebušne slinavke.
• Nasal congestion
• črevesna zapora
Norway Janssen-Cilag AS
Nizozemska Janssen-Cilag
• Very hard feces, fecal incontinence, abdominal discomfort, thirst, lip swelling, inflammation of the colon, reduced saliva
• zelo trdo blato, nezmožnost zadrževanja blata, bolečine v trebuhu, žeja, otekanje ustnic, vnetje kolona, zmanjšano izločanje sline
Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with RISPERDAL CONSTA.
Med zdravljenjem z zdravilom RISPERDAL CONSTA so zelo redko poročali o hiperglikemiji in poslabšanju obstoječe sladkorne bolezni.
The pharmacokinetics of risperidone following single doses of RISPERDAL CONSTA are linear in the dose range of 12.5-75 mg.
Pri odmerkih 12,5-75 mg je farmakokinetika risperidona po enkratnem odmerku zdravila Risperdal Consta linearna.
Keep the syringe and the vial access device aligned.
Injekcijsko brizgo in vialo držimo poravnano.
Ocular hyperemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia, Visual acuity reduced, Eye rolling, Glaucoma Ear and Labyrinth Disorders
Očesna hiperemija, izcedek iz očesa, otekanje oči, suho oko, povečano solzenje, fotofobija, zmanjšana ostrina vida, zavijanje oči, glavkom
• Talk to your doctor before using RISPERDAL CONSTA if you are pregnant, trying to become pregnant or breast-feeding.
• Če ste noseči, poskušate zanositi ali dojite se pred uporabo zdravila RISPERDAL CONSTA
Finland Jansen-Cilag Oy Metsänneidonkuja 8
Jansen-Cilag Oy Metsänneidonkuja 8 02130 Espoo Finska
• Shaking, muscle stiffness and problems feeding, all of which are reversible, have been seen in newborn babies when RISPERDAL was used during the last trimester of pregnancy.
• Pri novorojencih žensk, ki so v zadnjem trimesečju nosečnosti jemale risperidon, so opazili reverzibilne težave kot so tresenje, okorelost mišic in težave pri hranjenju.
For most patients the recommended dose is 25 mg intramuscular every two weeks.
Za večino bolnikov je priporočeni odmerek 25 mg intramuskularno vsaka dva tedna.
Rare side effects (affects 1 to 10 users in 10,000):
Redki neželeni učinki (pojavijo se pri 1 do 10 uporabnikov na vsakih 10.000)
Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg Risperdal Consta, while patients treated with higher oral doses should be considered for the higher Risperdal Consta dose of 37.5 mg.
Bolniki, ki jemljejo 4 mg ali manj risperidona v peroralni obliki, bi morali prejeti 25 mg zdravila RISPERDAL CONSTA, pri bolnikih, ki so prej prejemali večje odmerke risperidona v peroralni obliki pa je treba razmisliti o uporabi višjih odmerkov (37,5 mg) zdravila RISPERDAL CONSTA.
Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Toothache, Dry mouth, Stomach discomfort, Gastritis
Bolezni prebavil Pogosti bruhanje, driska, zaprtje, slabost, bolečine v trebuhu, dispepsija, bolečine zob, suha usta, nelagodje v želodcu, gastritis
Open the cover of the second reconstitution needle.
Odpremo pokrovček na drugi igli za rekonstitucijo.
• Obstruction of intestine
• zamašitev nosu
Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Da odkrijemo morebitne aritmije, moramo stalno nadzorovati EKG.
• You have kidney problems
• če imate težave z ledvicami
Unscrew the needle from the syringe and discard the needle appropriately.
Iglo odvijemo z injekcijske brizge in jo zavržemo v skladu s predpisi.
Common side effects (affects 1 to 10 users in 100):
Pogosti neželeni učinki (pojavijo se pri 1 do 10 uporabnikov na vsakih 100):
Higher active antipsychotic fraction plasma concentrations and a reduced clearance of the active antipsychotic fraction by on average 60% were observed in patients with renal insufficiency.
Pri bolnikih z motnjami v delovanju ledvic so v povprečju opazili 60 % višje plazemske koncentracije aktivne antipsihotične frakcije in 60 % zmanjšan očistek aktivne antipsihotične frakcije.
• Flushing, oily skin inflammation, dandruff, rash all over the body
• zardevanje, mastno vnetje kože, prhljaj, izpuščaj po celem telesu
Some patients may benefit from the higher doses of 37.5 mg or 50 mg.
Nekaterim bolnikom lahko koristijo višji odmerki 37,5 mg ali 50 mg. Odmerka se ne sme zviševati pogosteje kot vsake 4 tedne.
Solvent (solution) [To be completed nationally]
Vehikel (raztopina) [Poglavje bo dopolnjeno nacionalno]
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside
Napolnjeno brizgo odpremo tako, da zlomimo varovalo, belo zaporko pa nato odstranimo skupaj z notranjo gumijasto zaporko.
RISPERDAL Oral The following side effects have been reported with the use of RISPERDAL Oral.
Pri uporabi peroralnih oblik zdravila Risperdal so poročali o naslednjih neželenih učinkih.
No accumulation of risperidone was observed during long term use (12 months) in patients who were injected with 25-50 mg every two weeks.
Pri bolnikih, ki so jim dalj časa (12 mesecev) vsaka dva tedna injicirali 25-50 mg odmerek, kopičenja risperidona niso opazili.
Swab the connection point of the vial access device with preferred antiseptic prior to attaching the syringe to the vial access device.
Mesto stika z injekcijsko brizgo na nastavku pripomočka očistimo z antiseptikom, preden jo nanj pritrdimo.
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I - To be completed nationally]
IME ZDRAVILA Risperdal Consta in sorodna imena (glejte Dodatek 1) 12,5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem [Glejte Dodatek 1 - poglavje bo dopolnjeno nacionalno]
Risperidone should be used with caution in patients with known cardiovascular disease (e.g. heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease).
Pri bolnikih z znano kardiovaskularno boleznijo (npr: srčno popuščanje, srčni infarkt, motnje prevajanja, dehidracija, hipovolemija ali cerebrovaskularna bolezen), se mora risperidon uporabljati previdno.
Check with your doctor or pharmacist before using RISPERDAL CONSTA if:
Pred uporabo zdravila RISPERDAL CONSTA se posvetujte z zdravnikom ali s farmacevtom:
Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
V obdobju prvih treh tednov, po prvem injiciranju zdravila RISPERDAL CONSTA je treba zagotoviti nadomestilo z ustreznim antipsihotikom (glejte poglavje 5.2).
Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including RISPERDAL CONSTA, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB).
Pri bolnikih s Parkinsonovo boleznijo ali z demenco z Lewyjevimi telesci (DLB) je treba pri predpisovanju antipsihotikov, vključno z zdravilom RISPERDAL CONSTA, pretehtati pričakovane koristi in tveganje zdravljenja saj se Parkinsonova bolezen lahko ob jemanju risperidona poslabša.
STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
SEZNAM POMOŽNIH SNOVI [Poglavje bo dopolnjeno nacionalno]
Retinal artery occlusion Ear and labyrinth disorders Common
Neznana okluzija retinalne arterije Ušesne bolezni, vključno z motnjami labirinta Pogosti vertigo
The recommended starting dose is 25 mg Risperdal Consta every two weeks.
Priporočen začetni odmerek zdravila Risperdal Consta je 25 mg vsaka dva tedna.
Priapism may occur with RISPERDAL CONSTA treatment due to its alpha-adrenergic blocking effects.
Zaradi zaviralnega delovanja zdravila RISPERDAL CONSTA na alfa receptorje se lahko pojavi priapizem.
Hypothermia Immune system disorders Uncommon
Bolezni imunskega sistema Občasni preobčutljivost
HOW TO USE RISPERDAL CONSTA
KAKO UPORABLJATI ZDRAVILO RISPERDAL CONSTA
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder for prolonged-release suspension for intramuscular injection [See Annex I - To be completed nationally]
IME ZDRAVILA IN POT(I) UPORABE Risperdal Consta in sorodna imena (glejte Dodatek 1) 12,5 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem [Glejte Dodatek 1 - poglavje bo dopolnjeno nacionalno]
Agranulocytosis Nervous system disorders Very common Parkinsonismb, Akathisiab, Headache Common
Bolezni živčevja Zelo pogosti parkinsonizem b, akatizija b, glavobol
Hold the skirt of the vial access device during attachment to prevent spinning.
Nastavek držimo za rob, da preprečimo rotacijo.
The effectiveness of RISPERDAL CONSTA (25 mg and 50 mg) in the management of the manifestations of psychotic disorders (schizophrenia/schizoaffective disorder) was established in one 12-week, placebo-controlled trial in adult psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia.
V 12-tedenskem, s placebom kontroliranem preskušanju, v katerem so sodelovali hospitalizirani in ambulantni odrasli bolniki s simptomi psihotične motnje (shizofrenija/shizoafektivna motnja), ki so ustrezali kriterijem DSM-IV za shizofrenijo, so dokazali učinkovitost zdravila RISPERDAL CONSTA (25 mg in 50 mg) pri obvladovanju manifestacij psihotičnih obolenj.
Even if you are not being treated with RISPERDAL Oral but you experience any of the following, talk to your doctor:
Z zdravnikom se pogovorite tudi, če ne jemljete peroralnih oblik zdravila Risperdal, pa ste doživeli katerega izmed navedenih neželenih učinkov:
Czech
Češka:
• Rash, injection site pain, skin redness.
• izpuščaj, bolečina na mestu injiciranja, rdečica na koži.
RISPERDAL CONSTA and associated names (see Annex I) 12.5, 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I - To be completed nationally] Risperidone
NAVODILO ZA UPORABO RISPERDAL CONSTA ® 12,5 mg, 25 mg, 37,5 mg in 50 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem [Glejte Dodatek 1 - poglavje bo dopolnjeno nacionalno] Risperidon
RISPERDAL CONSTA is given as an intramuscular injection into the buttocks every two weeks, administered by a health care professional.
Zdravilo RISPERDAL CONSTA se daje vsaka dva tedna v obliki intramuskularne injekcije v zadnjico.
Intramuscural use
injiciranje vehikel
RISPOLEPT CONSTA® Portugal: RISPERDAL® CONSTA® Romania: RISPOLEPT CONSTA® Slovakia: RISPERDAL® CONSTA® Slovenia: RISPERDAL CONSTA® Spain:
Liechtenstein: RISPERDAL® CONSTA® Luxemburg: RISPERDAL® CONSTA® / BELIVON® CONSTA®
Dizziness, Sedation, Somnolence, Tremor, Dystoniab, Tardive dyskinesia, Dyskinesiab
Pogosti vrtoglavica, sedacija, somnolenca, tremor, distonija b, tardivna diskinezija,
• Vomiting, diarrhea, constipation, nausea, dry mouth, abdominal pain or stomach discomfort,
• bruhanje, driska, zaprtje, slabost, suha usta, bolečine v trebuhu, nelagodje v želodcu, želodčna okužba
Discard the vial appropriately.
Vialo zavržemo v skladu s predpisi.
SPECIAL STORAGE CONDITIONS [To be completed nationally]
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do: POSEBNA NAVODILA ZA SHRANJEVANJE [Poglavje bo dopolnjeno nacionalno]
RISPERDAL CONSTA is used to maintain the treatment of schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused RISPERDAL CONSTA is intended for patients who are currently treated with oral (e.g. tablets, capsules) antipsychotics.
Zdravilo RISPERDAL CONSTA se uporablja za vzdrževalno zdravljenje shizofrenije s simptomi, kot so prividi, prisluhi, občutki, ki niso resnični, neobičajna sumničavost ali zmedenost.
The following medicines may increase the effect of risperidone • Quinidine (used for certain types of heart disease)
• kinidin (uporablja se za zdravljenje določenih srčnih bolezni)
Renal or hepatic impairment
Ledvična in jetrna okvara
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder for prolonged-release suspension for intramuscular injection risperidone
in sorodna imena (glejte Dodatek 1) 50 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem risperidon
Inject the entire contents (solvent) of the syringe into the vial
V vialo injiciramo celotno vsebino (vehikel) iz injekcijske brizge.
Reproductive System and Breast Disorders Ejaculation disorder, Vaginal discharge, Menstrual disorder General Disorders and Administration Site Conditions Generalised oedema, Face oedema, Gait disturbance, Thirst, Chills, Peripheral coldness, Drug withdrawal syndrome
Motnje ejakulacije, izcedek iz nožnice, motnje menstrualnega ciklusa Splošne težave in spremembe na mestu aplikacije Generaliziran edem, edem obraza, motnje v telesni drži, žeja, mrazenje, hladne okončine, odtegnitveni sindrom,
NAME OF THE MEDICINAL PRODUCT
Učinki pri celotni skupini zdravil
Patients on higher dosages of the used oral antipsychotic should be considered for the higher RISPERDAL CONSTA dose of 37.5 mg.
Pri bolnikih, ki jemljejo večje odmerke antipsihotikov v peroralni obliki, je treba razmisliti o uporabi višjih odmerkov (37,5 mg) zdravila RISPERDAL CONSTA.
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.
Pri akutnem poslabšanju shizofrenije se zdravila RISPERDAL CONSTA v tritedenskem obdobju do nastopa učinka, po prvem injiciranju, ne sme uporabljati brez zagotovitve primernega odmerka risperidona v peroralni obliki ali predhodno uporabljenega antipsihotika.
before beginning treatment with RISPERDAL CONSTA.
Med uporabo zdravila RISPERDAL CONSTA se lahko zredite.
RISPERDAL CONSTA should be used with caution in patients with preexisting hyperprolactinaemia and in patients with possible prolactin-dependent tumours.
Pri bolnikih s predhodno obstoječo hiperprolaktinemijo in bolnikih z verjetnimi, od prolaktina odvisnimi tumorji je pri uporabi zdravila RISPERDAL CONSTA potrebna previdnost.
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder for prolonged-release suspension for intramuscular injection
in sorodna imena (glejte Dodatek 1) 37,5 mg prašek za suspenzijo za injiciranje s podaljšanim sproščanjem
For a full list of excipients, see section 6.1.
KAKOVOSTNA IN KOLIČINSKA SESTAVA [Poglavje bo dopolnjeno nacionalno] Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Your doctor will decide on the dose of RISPERDAL CONSTA that is right for you.
Vaš zdravnik se bo odločil kateri odmerek je primeren za vas.
The active substance is risperidone.
Zdravilna učinkovina je risperidon.
Hypersensitivity
Preobčutljivost na zdravila