FrancophonIA/ELRC3.0 huggingface dataset:
English: pollakiuria, urinary retention, dysuria
Slovenian: Bolezni sečil inkontinenca urina, polakiurija, retenca urina, disurija
English: Nervous system disorders parkinsonism , akathisia b,
Slovenian: Bolezni živčevja parkinsonizem b,
English: Blisters: Do not store above 30°C.
Slovenian: Shranjujte pri temperaturi do 30 C.
English: Torsade de pointes and ventricular fibrillation have been reported in association with overdose.
Slovenian: Pri prevelikem odmerjanju so poročali o torsade de pointes in fibrilaciji ventriklov.
English: • sore throat, cough, stuffy nose
Slovenian: • vneto grlo, kašelj, zamašen nos
English: For adolescents weighing 51 kg or more the dose may be increased within the range of 6 mg to 12 mg once a day.
Slovenian: Pri mladostnikih s telesno maso 51 kg in več se odmerek zdravila lahko poveča od 6 mg do 12 mg enkrat na dan.
English: In schizophrenia clinical trials, the proportions of subjects meeting a weight gain criterion of ≥ 7% of body weight were compared, revealing a similar incidence of weight gain for INVEGA 3 mg and 6 mg compared with placebo, and a higher incidence of weight gain for INVEGA 9 mg and 12 mg compared with placebo.
Slovenian: Primerjava je pokazala podobno incidenco povečanja telesne mase pri zdravilu INVEGA 3 mg in 6 mg kot pri placebu in večjo incidenco povečanja telesne mase pri zdravilu INVEGA 9 mg in 12 mg v primerjavi s placebom.
English: Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, there is no evidence in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Slovenian: Čeprav študije in vitro kažejo, da pri presnovi paliperidona sodelujeta tudi CYP2D6 in CYP3A4, ni nikakršnih dokazov in vivo, da bi bila ta dva izoencima pomembna pri presnovi paliperidona.
English: The active substance is paliperidone
Slovenian: Učinkovina je paliperidon.
English: INVEGA is used to treat schizophrenia in adults and in adolescents aged 15 years and older.
Slovenian: Zdravilo INVEGA se uporablja za zdravljenje shizofrenije pri odraslih in mladostnikih, starih 15 let in več.
English: Dosage adjustment, if indicated, should occur only after clinical reassessment.
Slovenian: Če je potrebno prilagajanje odmerka, ga lahko opravite šele po ponovni klinični oceni bolnikovega stanja.
English: In the schizoaffective disorder studies, a greater proportion of subjects in the total INVEGA dose group who were receiving concomitant therapy with an antidepressant or mood stabiliser experienced adverse events as compared to those subjects treated with INVEGA monotherapy.
Slovenian: V študijah shizoafektivne motnje so se v skupini, ki je prejemala zdravilo INVEGA, neželeni učinki pojavili pri večjem deležu preiskovancev, ki so prejemali sočasno zdravljenje z antidepresivi ali stabilizatorji razpoloženja, kot pri preiskovancih, ki so prejemali samostojno zdravljenje z zdravilom INVEGA.
English: Elderly Your doctor may reduce your dose of medicine if your kidney function is reduced.
Slovenian: Starostniki Če je delovanje vaših ledvic oslabljeno, vam bo morda zdravnik zmanjšal odmerek zdravila.
English: waist circumference increased, anorexia, blood triglycerides increased water intoxication, diabetic ketoacidosis c, hypoglycaemia, polydipsia, blood cholesterol increased hyperinsulinaemi
Slovenian: hiperglikemija, povečan obseg pasu, anoreksija, zvišana koncentracija trigliceridov v krvi zastrupitev z vodo, diabetična ketoacidoza c, hipoglikemija, polidipsija, zvišana koncentracija holesterola v krvi hiperinsulinemija
English: • blood vessel problems in the brain, coma due to uncontrolled diabetes, unresponsive to stimuli,
Slovenian: • težave s krvnimi žilami v možganih, koma zaradi neurejene sladkorne bolezni, neodzivnost na dražljaje, zmanjšana stopnja zavesti, tresenje glave
English: Your doctor will decide how much to give you.
Slovenian: Odmerek vam bo določil vaš zdravnik.
English: Menstrual disorder includes: menstruation irregular, oligomenorrhoea
Slovenian: Motnje menstruacije vključujejo: neredne menstruacije, oligomenorejo.
English: In the pooled adolescent schizophrenia population (12 years and older, N = 545) exposed to INVEGA, the frequency and type of undesirable effects were similar to those in adults except for the following ADRs that were reported more frequently in adolescents receiving INVEGA than adults receiving INVEGA (and more frequently than placebo): sedation/somnolence, parkinsonism, weight increase, upper respiratory tract infection, akathisia, and tremor were reported very commonly (≥ 1/10) in adolescents; abdominal pain, galactorrhoea, gynaecomastia, acne, dysarthria, gastroenteritis, epistaxis, ear infection, blood triglyceride increased, and vertigo were reported commonly (≥ 1/100, < 1/10) in adolescents.
Slovenian: O naslednjih neželenih učinkih pa so pri mladostnikih, ki so prejemali zdravilo INVEGA poročali pogosteje kot pri odraslih, ki so prejemali zdravilo INVEGA (in pogosteje kot pri placebu): pri mladostnikih so o sedaciji/somnolenci, parkinsonizmu, povečanju telesne mase, okužbi zgornjih dihal, akatiziji in tremorju poročali zelo pogosto (≥ 1/10); o bolečini v trebuhu, galaktoreji, ginekomastiji, aknah, dizartriji, gastroenteritisu, epistaksi, okužbi ušesa, povečani koncentraciji trigliceridov v krvi in vrtoglavici pa pogosto (≥ 1/100, < 1/10).
English: The ADRs that appeared to be dose-related included headache, sedation/somnolence, parkinsonism, akathisia, tachycardia, dystonia, dizziness, tremor, upper respiratory tract infection, dyspepsia, and musculoskeletal pain.
Slovenian: Neželeni učinki, ki so bili odvisni od odmerka, so bili glavobol, sedacija/somnolenca, parkinsonizem, akatizija, tahikardija, distonija, omotica, tremor, okužba zgornjih dihal, dispepsija in mišično-skeletna bolečina.
English: Dosage reduction for INVEGA should be considered when INVEGA is co-administered with valproate after clinical assessment.
Slovenian: Kadar se zdravilo INVEGA uporablja sočasno z valproatom, je treba po klinični oceni pretehtati možnost zmanjšanja odmerka zdravila INVEGA.
English: • a delay in menstrual periods, breast enlargement
Slovenian: • zapoznela menstruacija, povečanje prsi
English: Respiratory, thoracic and mediastinal disorders pharyngolarynge al pain, cough, nasal congestion dyspnoea, wheezing, epistaxis sleep apnoea syndrome, hyperventilation, pneumonia aspiration, respiratory tract congestion, dysphonia pulmonary congestion
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora faringolaringealna bolečina, kašelj, kongestija nosne sluznice dispneja, sopihanje, epistaksa sindrom apneje v spanju, hiperventilacija, aspiracijska pljučnica, kongestija dihal, disfonija pljučna kongestija
English: White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Slovenian: ali bel polivinilklorid (PVC) laminiran s polikloro-trifluoroetilenom (PCTFE)/aluminijevo pretisno plastjo.
English: The adverse drug reactions (ADRs) most frequently reported in clinical trials with adults were headache, insomnia, sedation/somnolence, parkinsonism, akathisia, tachycardia, tremor, dystonia, upper respiratory tract infection, anxiety, dizziness, weight increased, nausea, agitation, constipation, vomiting, fatigue, depression, dyspepsia, diarrhoea, dry mouth, toothache, musculoskeletal pain, hypertension, asthenia, back pain, electrocardiogram QT prolonged, and cough.
Slovenian: Najpogostejši neželeni učinki (NU), o katerih so poročali v kliničnih preskušanjih pri odraslih, so bili glavobol, nespečnost, sedacija/somnolenca, parkinsonizem, akatizija, tahikardija, tremor, distonija, okužba zgornjih dihal, anksioznost, omotica, zvečana telesna masa, navzea, agitacija, zaprtje, bruhanje, utrujenost, depresija, dispepsija, driska, suha usta, zobobol, mišično-skeletna bolečina, hipertenzija, astenija, bolečina v hrbtu, podaljšan interval QT na elektrokardiogramu in kašelj.
English: Paliperidone can have 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: Paliperidon ima lahko majhen do zmeren vpliv na sposobnost vožnje in upravljanja s stroji, zaradi možnosti pojava učinkov na živčevje ali oko (glejte poglavje 4.8), zato bolnikom svetujte, naj ne vozijo in ne upravljajo strojev, dokler ne bodo poznali svoje individualne občutljivosti na zdravilo INVEGA.
English: - if you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
Slovenian: - Če imate težave pri požiranju, želodčne težave ali črevesne težave, zaradi katerih slabše požirate ali imate motnje pri odvajanju blata.
English: Do not stop taking this medicine since you will lose the effects of the medicine.
Slovenian: Ne prenehajte z jemanjem, ker zdravilo ne bo več učinkovalo.
English: When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 4 days.
Slovenian: Kadar je indicirano povečanje odmerka, je priporočeno povečevanje po 3 mg na dan, v intervalih, daljših od 4 dni.
English: Adolescent Schizophrenia Study: R076477-PSZ-3003: 26-week, flexible-dose, active-controlled Intent-to-Treat Analysis Set.
Slovenian: Študija shizofrenije pri mladostnikih: R076477-PSZ-3003: : 26-tedenska, aktivno nadzorovana študija s prilagodljivimi odmerki; analiza populacije, vključene v študijo (ITT-Intent-to-Treat.
English: Statistically superior improvements in manic symptoms as measured by YMRS (secondary efficacy scale) were observed in patients from the flexible-dose study and the INVEGA higher dose in the second study.
Slovenian: Pri bolnikih v študiji s prožnim odmerkom in pri bolnikih, ki so v drugi študiji prejemali večji odmerek zdravila INVEGA, so opazili statistično večje izboljšanje maničnih simptomov, izmerjenih z lestvico YMRS (lestvica za sekundarno oceno učinkovitosti).
English: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha 1a-adrenergic antagonist effect, such as INVEGA (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravili z antagonističnim učinkom na receptorje alfa-1a, kakršno je tudi zdravilo INVEGA (glejte poglavje 4.8), so med operacijo sive mrene opazili sindrom ohlapne šarenice (IFIS).
English: • development of breasts in men, enlargement of the glands in your breasts, discharge from the breasts, vaginal discharge
Slovenian: • razvoj dojk pri moških, povečanje žlez v dojkah, izcedek iz dojke, izcedek iz nožnice
English: If your baby develops any of these symptoms you may need to contact your doctor.
Slovenian: če pri otroku opazite katerega od teh simptomov, se posvetujte z zdravnikom.
English: Administration of activated charcoal together with a laxative should be considered.
Slovenian: Po potrebi razmislite o dajanju aktivnega oglja skupaj z odvajalom.
English: Paliperidone is not extensively metabolised in the liver.
Slovenian: Paliperidon se v jetrih presnavlja le v manjši meri.
English: During post-marketing surveillance priapism has also been reported with paliperidone, which is the active metabolite of risperidone.
Slovenian: O pojavu priapizma so poročali tudi v postmarketinški uporabi paliperidona.
English: Dosing recommendations for elderly patients with normal renal function (≥ 80 mL/min) are the same as for adults with normal renal function.
Slovenian: Priporočila za odmerjanje zdravila pri starejših bolnikih z normalnim delovanjem ledvic (≥ 80 ml/min) so sicer enaka kot za odrasle z normalnim delovanjem ledvic, ker pa imajo lahko starejši bolniki zmanjšano delovanje ledvic, bo pri njih morda treba prilagoditi odmerek glede na delovanje bolnikovih ledvic (glejte poglavje Bolniki z ledvično okvaro).
English: If you stop INVEGA
Slovenian: Če ste prenehali jemati zdravilo INVEGA
English: INVEGA is not for use in children and adolescents who are under 18 years for the treatment of schizoaffective disorder.
Slovenian: Zdravilo INVEGA se ne uporablja za zdravljenje shizoafektivne motnje pri otrocih in mladostnikih, mlajših od 18 let.
English: • shortness of breath, wheezing, nosebleeds
Slovenian: • težko dihanje, piskajoče in sopihajoče dihanje, krvavitve iz nosa
English: The safety profile of risperidone may be pertinent.
Slovenian: Zato lahko koristne podatke najdete v varnostnem profilu risperidona.
English: • sleep walking
Slovenian: • hoja v spanju
English: ejaculation disorder, menstrual disorder e, galactorrhoea, sexual dysfunction, breast pain, breast discomfort priapism c, menstruation delayed gynaecomastia, breast engorgement,
Slovenian: Motnje reprodukcije in dojk amenoreja erektilna disfunkcija, motnje ejakulacije, motnje menstruacije e, galaktoreja, spolna disfunkcija, bolečina v dojkah, nelagodje v dojkah priapizem c, zapoznela menstruacija c, ginekomastija, povečanje dojk c, izcedek iz dojk, izcedek iz nožnice
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter ni potrebno prilagajanje odmerka.
English: INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets
Slovenian: INVEGA 3 mg tablete s podaljšanim sproščanjem INVEGA 6 mg tablete s podaljšanim sproščanjem INVEGA 9 mg tablete s podaljšanim sproščanjem INVEGA 12 mg tablete s podaljšanim sproščanjem
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL
English: Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point - LOCF for Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Slovenian: Študije shizofrenije: lestvica pozitivnih in negativnih simptomov pri shizofreniji (Positive and Negative Syndrome Scale for Schizophrenia-PANSS) Skupna ocena - sprememba od začetne vrednosti do končnega rezultata LOCF za študije R076477-SCH-303, R076477-SCH-304 in R076477-SCH-305: analizirana skupina, ki so jo nameravali zdraviti.
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti neželeni učinki: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/aluminium push-through child-resistant blister.
Slovenian: ali orientiran poliamid (OPA) in aluminijev polivinilklorid (PVC) z aluminijastim, za otroke varnim pretisnim omotom.
English: Adolescent Schizophrenia Study: R076477-PSZ-3001: 6-week, fixed-dose, placebo-controlled Intent-to-Treat Analysis Set.
Slovenian: Študija shizofrenije pri mladostnikih: R076477-PSZ-3001: 6-tedenska, s placebom nadzorovana študija z določenim odmerkom; analiza populacije, vključene v študijo (ITT-Intent-to-Treat).
English: The primary efficacy endpoint was defined as a decrease in total Positive and Negative Syndrome Scale (PANSS) scores as shown in the following table.
Slovenian: Odmerki zdravila INVEGA, ki so se razlikovali med temi tremi študijami, so bili v razponu od 3 do 15 mg enkrat na dan. Primarni cilj za dokaz učinkovitosti je bil določen kot zmanjšanje skupne ocene po lestvici pozitivnih in negativnih simptomov (Positive and Negative Syndrome Scale-PANSS), kot je prikazano v spodnji preglednici.
English: What INVEGA contains
Slovenian: Kaj vsebuje navodilo
English: Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.
Slovenian: Pretisni omoti: polivinilklorid (PVC), laminiran s polikloro-trifluoroetilenom (PCTFE) in aluminijasto pretisno plastjo.
English: When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days.
Slovenian: Kadar je indicirano povečanje odmerka, je priporočeno povečevanje po 3 mg na dan, v intervalih daljših od 5 dni.
English: System Organ Class
Slovenian: Razdelitev po organskih sistemih
English: Musculoskelet al and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, joint swelling, muscular weakness, neck pain rhabdomyolysis c, posture abnormal
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišično-skeletna bolečina, bolečina v hrbtu, artralgija zvišanje koncentracije kreatinin fosfokinaze v krvi, mišični krč, togost sklepov, otekanje sklepov, šibkost mišic, bolečina v vratu rabdomioliza c, nenormalna telesna drža
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death.
Slovenian: Vendar je tveganje za možgansko kap ali smrt pri starejših bolnikih z demenco, ki so jih zdravili z drugimi, podobnimi zdravili lahko povečano (glejte poglavje 4.
English: Schizophrenia Studies: Proportion of Subjects with Responder Status at LOCF End Point Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305: Intent-to-Treat Analysis Set
Slovenian: Študije shizofrenije: Delež preiskovancev, ki so se odzvali na zdravljenje ob koncu LOCF Študije R076477-SCH-303, R076477-SCH-304 in R076477-SCH-305: Analiza populacije, vključene v študije (ITT-Intent-to-Treat)
English: 14 prolonged-release tablets 28 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
Slovenian: 14 tablet s podaljšanim sproščanjem 28 tablet s podaljšanim sproščanjem 49 tablet s podaljšanim sproščanjem 56 tablet s podaljšanim sproščanjem 98 tablet s podaljšanim sproščanjem
English: 14 prolonged-release tablets 28 prolonged-release tablets 30 prolonged-release tablets 49 prolonged-release tablets 56 prolonged-release tablets 98 prolonged-release tablets
Slovenian: 14 tablet s podaljšanim sproščanjem 28 tablet s podaljšanim sproščanjem 30 tablet s podaljšanim sproščanjem 49 tablet s podaljšanim sproščanjem 56 tablet s podaljšanim sproščanjem 98 tablet s podaljšanim sproščanjem
English: Skin and subcutaneous tissue disorders pruritus, rash urticaria, alopecia, eczema, acne angioedema, drug eruption c, hyperkeratosis, dry skin, erythema, skin discolouration, seborrhoeic dermatitis, dandruff
Slovenian: Bolezni kože in podkožja pruritus, izpuščaj urtikarija, alopecija, ekcem, akne angioedem, medikamentozni izpuščaj c, hiperkaratoza, suha koža, razbarvanje kože, seboreični dermatitis, prhljaj
English: 7 & 10 TABLET PVC-PTFE/ALU BLISTER (for white and clear blister)
Slovenian: PRETISNI OMOTI IZ PVC-PTFE/ALU S 7 IN 10 TABLETAMI (za bele in prozorne pretisne omote)
English: How to take INVEGA
Slovenian: Kako jemati zdravilo INVEGA
English: • common cold symptoms
Slovenian: • simptomi nahoda
English: Immune system disorders anaphylactic reaction,
Slovenian: Bolezni imunskega sistema anafilaktična reakcija, preobčutljivost
English: Swallow whole, do not chew, divide or crush.
Slovenian: Tableto pogoltnite celo, ne smete je žvečiti, razdeliti ali drobiti.
English: Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Slovenian: Srednja sprememba (SD) Vrednost p (v primerjavi s placebom)
English: confusional state, libido decreased, anorgasmia, nervousness, nightmare catatonia, somnambulism, blunted affect
Slovenian: Psihiatrične motnje nespečnost manija, agitacija, depresija, anksioznost motnje spanja, zmedenost, zmanjšan libido, anorgazmija, živčnost, nočne more katatonija, somnambulizem, otopelost
English: If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine.
Slovenian: Če se pripravljate na operacijo sive mrene, morate o jemanju tega zdravila obvestiti zdravnika okulista.
English: Withdrawal of INVEGA may be needed.
Slovenian: Morda bo potrebno prekiniti zdravljenje z zdravilom INVEGA.
English: An antiemetic effect was observed in preclinical studies with paliperidone.
Slovenian: V predkliničnih študijah s paliperidonom so opazili antiemetično delovanje.
English: • abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, indigestion,
Slovenian: • bolečina v trebuhu, nelagodje v trebuhu, bruhanje, slabost, zaprtje, driska, prebavne motnje,
English: Dizziness and vision problems may occur during treatment with this medicine (see section 4, possible side effects).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med jemanjem tega zdravila lahko pride do vrtoglavice ali težav z vidom (glejte poglavje 4.
English: Schizoaffective Disorder Studies: Secondary Efficacy Parameter, Proportion of Subjects with Responder Status at LOCF End Point: Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Slovenian: Študije shizoafektivne motnje: Sekundarni parameter učinkovitosti, delež preiskovancev, ki so se odzvali na zdravljenje ob končni točki LOCF: študiji R076477-SCA-3001 in R076477-SCA-3002: Analiza populacije, vključene v študije (ITT-Intent-to-Treat)
English: Schizoaffective Disorder Studies: Primary Efficacy Parameter, PANSS Total Score Change from Baseline from Studies R076477-SCA-3001 and R076477-SCA-3002: Intent-to-Treat Analysis Set
Slovenian: Študije shizoafektivne motnje: Primarni parameter učinkovitosti, sprememba skupnega rezultata vprašalnika PANSS glede na izhodiščno vrednost v študijah R076477-SCA-3001 in R076477-SCA-3002: Analiza populacije, vključene v študije (ITT-Intent-to-Treat)
English: As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarely with patients taking INVEGA, your doctor may check your white blood cell counts.
Slovenian: Pri bolnikih, ki so jemali zdravilo INVEGA so zelo redko opazili nevarno majhno število belih krvnih celic, ki jih potrebujete za obrambo pred okužbo.
English: Hyperglycaemia, diabetes mellitus, and exacerbation of pre-existing diabetes have been reported during treatment with paliperidone.
Slovenian: Med zdravljenjem s paliperidonom so poročali o hiperglikemiji, sladkorni bolezni in poslabšanju sladkorne bolezni.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Srednja sprememba (SD)
English: Iron oxide (black) (E172) Propylene glycol Hypromellose
Slovenian: Tiskarsko črnilo: črni železov oksid (E172) propilenglikol hipromeloza
English: Paliperidone did not impair the neurobehavioural development in males at doses up to 2.5 mg/kg/day.
Slovenian: Pri mladičih podganjih samcev, paliperidon v odmerku do največ 2,5 mg/kg/dan, ni škodil razvoju živčevja in obnašanja.
English: INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets paliperidone
Slovenian: INVEGA 3 mg tablete s podaljšanim sproščanjem INVEGA 6 mg tablete s podaljšanim sproščanjem INVEGA 9 mg tablete s podaljšanim sproščanjem INVEGA 12 mg tablete s podaljšanim sproščanjem paliperidon
English: Children and adolescents INVEGA is not for use in children and adolescents under 15 years for the treatment of schizophrenia.
Slovenian: Zdravilo INVEGA se ne uporablja za zdravljenje shizofrenije pri otrocih in mladostnikih, mlajših od 15 let.
English: Iron oxide (Black) (E172) Propylene glycol Hypromellose
Slovenian: Tiskarsko črnilo črni železov oksid (E172) propilenglikol hipromeloza
English: CARTON FOR OPA-ALUMINIUM-PVC/ALUMINIUM BLISTER
Slovenian: ŠKATLA ZA PRETISNE OMOTE IZ OPA-ALU-PVC/ALU
English: Ear and labyrinth disorders vertigo, tinnitus, ear pain
Slovenian: Ušesne bolezni, vključno z matnjami labirinta vrtoglavica, tinitus, bolečina v ušesu
English: During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken INVEGA.
Slovenian: Če ste jemali ali jemljete zdravilo INVEGA, lahko med operacijo sive mrene pride do stanja, ki se imenuje medoperativni sindrom ohlapne šarenice (IFIS).
English: In all three studies, INVEGA was superior to placebo on PSP and CGI-S. Efficacy was also evaluated by calculation of treatment response (defined as decrease in PANSS Total Score ≥ 30%) as a secondary endpoint.
Slovenian: Dodatni cilj študije je bila ocena odziva na zdravljenje (opredeljen kot zmanjšanje skupnega rezultata PANSS za ≥ 30%).