natgillin/translations-raw huggingface dataset:
Ventricular tachycardia/fibrillation, sudden death (see section 4.4)11
Prekatna tahikardija/fibrilaci ja, nenadna smrt (glejte poglavje 4.4)11
The daily dose of ZYPREXA VELOTAB is between 5 mg and 20 mg.
Dnevni odmerek zdravila ZYPREXA VELOTAB je med 5 mg in 20 mg.
ZYPREXA VELOTAB tablets break easily, so you should handle the tablets carefully.
ZYPREXA VELOTAB tablete se zlahka lomijo, zato z njimi ravnajte previdno.
You should take your ZYPREXA VELOTAB tablets once a day following the advice of your doctor.
Zdravilo ZYPREXA VELOTAB tablete jemljite enkrat na dan, in sicer upoštevajte nasvet zdravnika.
ZYPREXA VELOTAB has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Zdravilo ZYPREXA VELOTAB dokazano preprečuje ponoven pojav teh simptomov pri bolnikih z bipolarno motnjo, pri katerih se je manična epizoda po zdravljenju z olanzapinom izboljšala.
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
450 mg, vendar so poročali tudi o preživetju po akutnem prevelikem odmerjanju z odmerkom približno 2 g peroralnega olanzapina.
The exact amount is shown on your ZYPREXA VELOTAB pack.
Natančna količina je navedena na pakiranju vašega zdravila ZYPREXA VELOTAB.
Тел : + 359 2 491 41 40
- България Тел: + 359 2 491 41 40
Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.
Rumena, okrogla, z zamrzovanjem sušena farmacevtska oblika, ki se hitro dispergira in jo za uporabo bodisi položimo v usta bodisi dispergiramo v vodi ali drugi ustrezni pijači.
Haematologic toxicity: Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Pri vsaki vrsti so odkrili učinke na hematološke parametre, vključno z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifičnim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksičnosti za kostni mozeg.
Olanzapine orodispersible tablets may be used as an alternative to olanzapine coated tablets.
Olanzapin orodisperzibilne tablete se lahko uporablja kot alternativa olanzapin obloženim tabletam.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels(see sections 4.8 and 5.1).
13-17 let kažejo na različne neželene učinke, vključno s povečanjem telesne mase, spremembami v kazalcih presnove in zvišanjih ravni prolaktina (glejte poglavji 4.8 in 5.1).
Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
ZYPREXA VELOTAB, moramo opazovati za znake in simptome hiperglikemije (kot so polidipsija, poliurija, polifagija in šibkost) ter redno spremljati bolnike s sladkorno boleznijo ali dejavniki tveganja za sladkorno bolezen glede poslabšanja nadzora glukoze.
28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
28 orodisperzibilnih tablet 35 orodisperzibilnih tablet 56 orodisperzibilnih tablet 70 orodisperzibilnih tablet 98 orodisperzibilnih tablet
ZYPREXA VELOTAB should be stored in its original pack in order to protect from light and moisture.
Zdravilo ZYPREXA VELOTAB shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Med zdravljenjem z olanzapinom v kombinaciji z litijem ali divalproeksom se je pri 17,4 % bolnikov med akutnim zdravljenjem ( do 6 tednov) pojavilo povečanje telesne mase za
Do not stop taking your tablets just because you feel better.
Če ste prenehali jemati zdravilo ZYPREXA VELOTAB Ne prenehajte jemati tablet samo zato, ker se počutite bolje.
An allergic reaction may be recognised as a rash, itching or shortness of breath.
Alergijsko reakcijo lahko prepoznate kot izpuščaj, srbenje ali težave z dihanjem.
You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA VELOTAB can pass into breast milk.
Ko dojite, tega zdravila ne smete jemati, ker lahko majhne količine zdravila ZYPREXA VELOTAB
Aluminium blister strips in cartons of 28, 35, 56, 70 or 98 orodispersible tablets per carton.
Aluminijasti pretisni omoti v škatlah po 28, 35, 56, 70 ali 98 orodisperzibilnih tablet.
ZYPREXA VELOTAB orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
ZYPREXA VELOTAB orodisperzibilno tableto naj se položi v usta, kjer se hitro dispergira v slini,
ZYPREXA VELOTAB contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause an allergic reaction in some people.
Zdravilo ZYPREXA VELOTAB vsebuje natrijev metilparahidroksibenzoat in natrijev propilparahidroksibenzoat, ki lahko pri nekaterih ljudeh povzročita alergijsko reakcijo.
Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine.
Bolniki, ki ne smejo zaužiti fenilalanina, naj se zavedajo, da zdravilo ZYPREXA VELOTAB vsebuje aspartam, ki je vir fenilalanina.
Patients who cannot take mannitol should note that ZYPREXA VELOTAB contains mannitol.
Bolniki, ki ne smejo prejeti manitola, naj se zavedajo, da zdravilo ZYPREXA VELOTAB vsebuje manitol.
Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
Primite pretisni omot na robovih in ločite en pretisni razdelek od ostalih razdelkov omota tako,
Consult your doctor if your symptoms return but do not stop taking ZYPREXA VELOTAB unless your doctor tells you to.
Če se simptomi povrnejo, se posvetujte s svojim zdravnikom, vendar ne prenehajte jemati zdravila ZYPREXA
ZYPREXA VELOTAB orodispersible tablets are for oral use.
ZYPREXA VELOTAB tablete so za peroralno uporabo.
Systemic Symptoms (DRESS)
Reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
What ZYPREXA VELOTAB looks like and contents of the pack ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg and 20 mg are yellow orodispersible tablets.
Izgled zdravila ZYPREXA VELOTAB in vsebina pakiranja ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg in 20 mg so rumene orodisperzibilne tablete.
Mannitol ZYPREXA VELOTAB orodispersible tablet contains mannitol.
Manitol ZYPREXA VELOTAB orodisperzibilna tableta vsebuje manitol.
ZYPREXA VELOTAB with alcohol
Jemanje zdravila ZYPREXA VELOTAB skupaj z alkoholom
Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment.
Jetrno delovanje Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, ALT in AST, posebno na začetku zdravljenja.
An updated RMP should be submitted: • At the request of the European Medicines Agency
Posodobljen RMP je treba predložiti:
If you suddenly stop taking ZYPREXA VELOTAB, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Če nenadno prenehate jemati zdravilo ZYPREXA VELOTAB, se lahko pojavijo simptomi, kot so znojenje, nespečnost, tresenje, občutek tesnobe ali slabost in bruhanje.
ZYPREXA VELOTAB orodispersible tablet contains aspartame, which is a source of phenylalanine.
ZYPREXA VELOTAB orodisperzibilna tableta vsebuje aspartam, ki je vir fenilalanina.
However, the incidence of death was higher in olanzapine-treated than in placebotreated patients independent of these risk factors.
Vendar je bila incidenca smrti, neodvisno od omenjenih dejavnikov tveganja, večja pri bolnikih zdravljenih z olanzapinom, kot pri bolnikih zdravljenih s placebom.
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs. 1.5 %, respectively).
povezano z demenco in/ali vedenjskimi motnjami (povprečna starost 78 let), je bilo 2-kratno povečanje incidence smrti pri bolnikih, zdravljenih z olanzapinom, v primerjavi z bolniki, zdravljenimi s placebom (3,5 % v primerjavi z 1,5 %).
Excipients with known effect: Each orodispersible tablet contains 0.60 mg aspartame,
Pomožne snovi z znanim učinkom: Ena orodisperzibilna tableta vsebuje 0,60 mg aspartama
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
V 18-mesečni študiji sočasnega zdravljenja pri bolnikih z manično ali mešano epizodo, stabiliziranih z olanzapinom skupaj s stabilizatorjem razpoloženja (litij ali valproat), dolgotrajno sočasno zdravljenje z olanzapinom skupaj z litijem ali valproatom ni bilo statistično značilno bolj ugodno kot zdravljenje samo z litijem ali samo valproatom pri odlogu ponovnega pojava bipolarne motnje,
Separate one blister cell from the strip.
Ločite en pretisni razdelek od ostalih razdelkov pretisnega omota.
Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
krči (epilepsija), koma, kombinacija zvišane telesne temperature, hitrega dihanja, znojenja, okorelosti mišic in omotičnosti ali zaspanosti, upočasnjeno dihanje, aspiracija, visok krvni tlak ali nizek krvni tlak, motnje srčnega ritma.
Do not drink any alcohol if you have been given ZYPREXA VELOTAB as together with alcohol it may make you feel drowsy.
Če ste dobili zdravilo ZYPREXA VELOTAB, ne pijte nobenega alkohola, saj lahko zdravilo ZYPREXA VELOTAB in alkohol skupaj povzročita občutek zaspanosti.
If you take more ZYPREXA VELOTAB than you should Patients who have taken more ZYPREXA VELOTAB than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech,
Če ste vzeli večji odmerek zdravila ZYPREXA VELOTAB, kot bi smeli Bolniki, ki so vzeli večji odmerek zdravila ZYPREXA VELOTAB, kot bi smeli, so imeli naslednje simptome: hitro bitje srca, vznemirjenost/nasilnost, težave pri govoru, nenavadne zgibke (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo models.
5-HT2 kot za dopaminske D2 receptorje in večjo 5-HT2 kot D2 aktivnost v modelih in vivo.
How to take ZYPREXA VELOTAB
Kako jemati zdravilo ZYPREXA VELOTAB
MARKETING AUTHORISATION NUMBER (S)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE GLEDE DOVOLJENJA ZA
Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
Pomožne snovi: želatina, manitol (E421), aspartam (E951), natrijev metilparahidroksibenzoat (E219), natrijev propilparahidroksibenzoat (E217).
Following short term treatment (median duration 47 days), weight gain ≥ 7% of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %).
S kratkoročnim zdravljenjem (srednje trajanje 47 dni) povezano zvečanje telesne mase za ≥ 7 % od osnovne telesne mase je bilo zelo pogosto (22,2 %), ≥ 15 %
In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/hr).
Okvarjeno delovanje ledvic Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina < 10 ml/min) v primerjavi z zdravimi osebami ni bilo značilne razlike v srednjem razpolovnem času izločanja (37,7 v primerjavi z 32,4 ure)
ZYPREXA VELOTAB contains aspartame, mannitol and sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
Zdravilo ZYPREXA VELOTAB vsebuje aspartam, manitol, natrijev metilparahidroksibenzoat in natrijev propilparahidroksibenzoat
If you stop taking ZYPREXA VELOTAB
Če ste pozabili vzeti zdravilo ZYPREXA VELOTAB
There is a risk of feeling drowsy when you are given ZYPREXA VELOTAB.
Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo ZYPREXA VELOTAB, počutili zaspane.
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate Olanzapine orodispersible tablet contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
Natrijev metilparahidroksibenzoat in natrijev propilparahidroksibenzoat Orodisperzibilna tableta olanzapina vsebuje natrijev metilparahidroksibenzoat in natrijev propilparahidroksibenzoat.
The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih aminotransferaz (glejte poglavje 4.4), izpuščaj, astenija, utrujenost, pireksija, artralgija, zvišana alkalna fosfataza, visoka raven gama-glutamiltransferaze, visoka raven sečne kisline, visoka raven kreatin-fosfokinaze in edem.
• The other ingredients are - gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217).
- Pomožne snovi so želatina, manitol (E421), aspartam (E951), natrijev metilparahidroksibenzoat (E219) in natrijev propilparahidroksibenzoat (E217).
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2 % of overdose cases) and cardiopulmonary arrest.
komo, možen nevroleptični maligni sindrom, depresijo dihanja, aspiracijo, hipertenzijo ali hipotenzijo, motnje srčnega ritma (< 2 % primerov prevelikega odmerjanja) in kardiopulmonalni zastoj.
Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Zvečanje osnovne telesne mase za ≥ 7 %, ≥ 15 % in ≥ 25 % se je pri dolgoročni izpostavljenosti bolnikov (vsaj 48 tednov) pojavljalo zelo pogosto (v
Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Pri nekaj psih, ki so prejemali 8 ali 10 mg/kg/dan (celotno izpostavljanje olanzapinu [površina pod krivuljo] je 12do 15-krat večje kot pri človeku, ki dobi 12-miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets
ZYPREXA VELOTAB 5 mg orodisperzibilne tablete ZYPREXA VELOTAB 10 mg orodisperzibilne tablete ZYPREXA VELOTAB 15 mg orodisperzibilne tablete ZYPREXA VELOTAB 20 mg orodisperzibilne tablete olanzapin
Only take other medicines while you are on ZYPREXA VELOTAB if your doctor tells you that you can. You might feel drowsy if ZYPREXA VELOTAB is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Če jemljete zdravilo ZYPREXA VELOTAB v kombinaciji z zdravili za zdravljenje depresije, zdravili za zdravljenje občutkov tesnobe ali zdravili, ki vam pomagajo spati (pomirjevala), se lahko počutite zaspani.
Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z zdravilom ZYPREXA VELOTAB, moramo redno spremljati glede lipidov, v skladu z znanimi priporočili za antipsihotike,
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPREXA VELOTAB.
• Pri bolnikih, ki so jemali zdravilo ZYPREXA VELOTAB, so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
What you need to know before you take ZYPREXA VELOTAB 3.
Kaj morate vedeti, preden boste vzeli zdravilo ZYPREXA VELOTAB Ne jemljite zdravila ZYPREXA VELOTAB:
13 Following short term treatment (median duration 22 days), weight gain ≥ 7% of baseline body weight (kg) was very common (40.6 %), ≥ 15% of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), za ≥ 15 % pogosto (7,1 %) in za ≥ 25 %
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes ; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever, joint pain and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Pogosti neželeni učinki (lahko prizadenejo do 1 od 10 bolnikov) vključujejo spremembe v ravneh nekaterih krvnih celic in maščob v krvnem obtoku in v začetnih obdobjih zdravljenja, začasno povišanje jetrnih encimov, zvišanja v ravni sladkorjev v krvi in urinu, zvišanja v ravni sečne kisline in kreatin fosfokinaze v krvi, večji občutek lakote, omotico, nemirnost, tresenje, nenavadne gibe
Thromboembolism hypotension10
Žilne bolezni Ortostatska hipotenzija10
Potential interactions affecting olanzapine
Zmožnost vplivanja olanzapina na druga zdravila
INFORMATION IN BRAILLE ZYPREXA VELOTAB 20 mg
PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 20 mg
• Weight gain has been seen in patients taking ZYPREXA VELOTAB.
• Pri bolnikih, ki so jemali zdravilo ZYPREXA VELOTAB, so opazili porast telesne mase.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥ 0.01 % and < 0.1 %) when olanzapine is stopped abruptly.
Prekinitev zdravljenja Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
Each ZYPREXA VELOTAB orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
5 mg, 10 mg, 15 mg ali 20 mg učinkovine.
Reproductive system and breast disorders Erectile dysfunction in males
Erektilna disfunkcija pri moških
0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
0,30 mg natrijevega metilparahidroksibenzoata 0,10 mg natrijevega propilparahidroksibenzoata
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 4,39 mmol/l
INFORMATION IN BRAILLE ZYPREXA VELOTAB 5 mg
PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 5 mg
Dystonia (including oculogyration) 11
(vključno z okulogiracijo) 11 Tardivne diskinezije11
INFORMATION IN BRAILLE ZYPREXA VELOTAB 10 mg
PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 10 mg
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda.
Ime in naslov izdelovalcev, odgovornih za sproščanje serije
INFORMATION IN BRAILLE ZYPREXA VELOTAB 15 mg
PODATKI V BRAILLOVI PISAVI ZYPREXA VELOTAB 15 mg
0.225 mg sodium methyl parahydroxybenzoate, 0.075 mg sodium propyl parahydroxybenzoate.
0,225 mg natrijevega metilparahidroksibenzoata 0,075 mg natrijevega propilparahidroksibenzoata ZYPREXA VELOTAB 20 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 20 mg olanzapina.
ZYPREXA VELOTAB 20 mg orodispersible tablets
ZYPREXA VELOTAB 20 mg orodisperzibilne tablete olanzapin
Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
6.1 Seznam pomožnih snovi želatina manitol (E421) aspartam (E951) natrijev metilparahidroksibenzoat (E219) natrijev propilparahidroksibenzoat (E217)
ZYPREXA VELOTAB 5 mg orodispersible tablets
ZYPREXA VELOTAB 5 mg orodisperzibilne tablete olanzapin
0.1125 mg sodium methyl parahydroxybenzoate, 0.0375 mg sodium propyl parahydroxybenzoate.
0,1125 mg natrijevega metilparahidroksibenzoata 0,0375 mg natrijevega propilparahidroksibenzoata ZYPREXA VELOTAB 10 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 10 mg olanzapina.
ZYPREXA VELOTAB 10 mg orodispersible tablets
ZYPREXA VELOTAB 10 mg orodisperzibilne tablete olanzapin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z ZYPREXA VELOTAB 20 mg ORODISPERZIBILNIMI TABLETAMI
ZYPREXA VELOTAB 15 mg orodispersible tablets
ZYPREXA VELOTAB 15 mg orodisperzibilne tablete olanzapin
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms ( including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
občasno povezano s ketoacidozo (ketoni v krvi in urinu) ali komo, krče, običajno povezane s krči (epileptičnimi napadi) v preteklosti, mišično okorelost ali krče (vključno z obračanjem zrkel), sindrom nemirnih nog, težave pri govoru, jecljanje, upočasnjen srčni utrip, občutljivost za sončno svetlobo,
0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
0,15 mg natrijevega metilparahidroksibenzoata 0,05 mg natrijevega propilparahidroksibenzoata ZYPREXA VELOTAB 15 mg orodisperzibilne tablete Ena orodisperzibilna tableta vsebuje 15 mg olanzapina.