natgillin/translations-raw huggingface dataset:
Patients treated with any antipsychotic medicines, including olanzapine, 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.
Bolnike, zdravljene s katerimkoli antipsihotikom, vključno z zdravilom Olazax Disperzi, 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.
6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton.
6.5 Vrsta ovojnine in vsebina Aluminij/aluminij pretisni omoti v škatlah po 28 & 56 tablet.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študije interakcij so izvajali samo pri odraslih.
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
Children and adolescents Olazax Disperzi is not for patients who are under 18 years.
Zdravilo Olazax Disperzi ni namenjeno bolnikom, mlajšim od 18 let.
Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before the administration.
Drug način uporabe je, da tableto dispergiramo v polnem kozarcu vode ali druge ustrezne pijače (pomarančni sok, jabolčni sok, mleko ali kava) neposredno pred zaužitjem.
You can also place the tablet in a full glass or cup of water orange juice, apple juice, milk or coffee, and stir.
Tableto lahko daste tudi v poln kozarec ali skodelico vode ali v drugo primerno pijačo (pomarančni sok, jabolčni sok, mleko ali kava) in tekočino premešate.
Glucosuria Increased appetite
Povečan apetit
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
If you take more Olazax Disperzi than you should Patients who have taken more Olazax Disperzi than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Bolniki, ki so vzeli večji odmerek zdravila Olazax Disperzi, 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.
Elevated glucose levels 4
Zvišane ravni glukoze4
Olazax Disperzi orodispersible tablet contains aspartame, which is a source of phenylalanine.
Zdravilo Olazax Disperzi orodisperzibilne tablete vsebuje aspartam, ki je vir fenilalanina.
Controlled efficacy data in adolescents (ages 13 to 17 years)are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Nadzorovani podatki o učinkovitosti pri mladostnikih (starih 13 do 17 let) so omejeni na kratkoročne študije pri shizofreniji (6 tednov) in maniji povezani z bipolarno I motnjo (3 tedni), ki vključujejo manj kot 200 mladostnikov.
How to store Olazax Disperzi Contents of the pack and other information
Shranjevanje zdravila Olazax Disperzi Vsebina pakiranja in dodatne informacije
Olazax Disperzi tablets are for oral use.
Orodisperzibilne tablete Olazax Disperzi so za peroralno uporabo.
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).
A lower starting dose (5 mg) should be considered for such patients.
Bolniki z okvarjenim ledvičnim in/ali jetrnim delovanjem Pri teh bolnikih je treba upoštevati nižji začetni odmerek (5 mg).
SPECIAL STORAGE CONDITIONS Store below 30C
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Bolezni živčevja Zelo pogosti: Sedacija (vključno s: hipersomnijo, letargijo, zaspanostjo)
Neuroleptic malignant syndrome (see section 4.4)12
Nevroleptični maligni sindrom (glejte poglavje 4.4)12 Odtegnitveni simptomi7, 12
Seizures where in most cases a history of seizures or risk factors for seizures were reported 11
Epileptični napadi, pri katerih so jih v večini primerov imeli že kdaj prej ali so poročali o dejavnikih tveganja za epileptične napade11 Distonija
Mannitol (E 421) Microcrystalline cellulose Aspartame (E 951) Crospovidone Magnesium stearate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol E 421 mikrokristalna celuloza aspartam E 951 krospovidon magnezijev stearat
Investigations Elevated plasma prolactin levels 8
Preiskave Zvišane plazemske koncentracije prolaktina8
Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter .
Priporoča se ustrezno klinično spremljanje v skladu z znanimi priporočili za antipsihotike, npr. merjenje glukoze v krvi na začetku, 12 tednov po začetku jemanja olanzapina in nato enkrat na leto.
Do not drink any alcohol if you have been given Olazax Disperzi as together with alcohol it may make you feel drowsy.
Jemanje zdravila Olazax Disperzi skupaj alkoholom Če ste dobili zdravilo Olazax Disperzi, ne pijte nobenega alkohola, saj lahko zdravilo Olazax Disperzi in alkohol skupaj povzročita občutek zaspanosti.
Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Prehodna asimptomatska zvišanja jetrnih aminotransferaz (ALT, AST), posebno na začetku zdravljenja (glejte poglavje 4.4)
Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Pediatrična populacija Nadzorovani podatki o učinkovitosti pri mladostnikih (starih 13 do 17 let) so omejeni na kratkoročne študije pri shizofreniji (6 tednov) in maniji povezani z bipolarno I motnjo (3 tedni), ki vključujejo manj kot 200 mladostnikov.
However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
(seznam EURD), predvidenih na podlagi člena 107c (7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Patients treated with any antipsychotic medicines, including olanzapine, 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 Olazax Disperzi, moramo redno spremljati glede lipidov, v skladu z znanimi priporočili za antipsihotike, npr. na začetku, 12 tednov po začetku jemanja olanzapina in nato vsakih 5 let.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5-HT2 kot za dopaminske D2 receptorje in večjo 5-HT2 kot D2 aktivnost v modelih in vivo.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/
(≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l - < 1.467 mmol/l) to high (≥ 1.467 mmol/l).
(≥ 1,016 mmol/l - < 1,467 mmol/l) na visoke (≥ 1,467 mmol/l).
Keep this medicine out of sight and reach of children
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ POGLEDA IN DOSEGA OTROK
Ventricular tachycardia/fibri llation, sudden death (see section 4.4)11
Prekatna tahikardija/fibrilacij a, nenadna smrt (glejte poglavje 4.4)11
Store below 30 C.
Shranjujte pri temperaturi do 30 °C.
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3 % verses 0.4 %, respectively).
Pri bolnikih, zdravljenih z olanzapinom, je bila 3-krat večja pojavnost CVAE v primerjavi z bolniki, ki so prejemali placebo (1,3 % v primerjavi z 0,4 %).
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke .
obolenje jeter ali ledvic bolezni krvi srčno obolenje sladkorno bolezen krče Če ste bolnik z demenco, morate vi ali vaš skrbnik/sorodnik povedati vašemu zdravniku, če ste kdaj doživeli možgansko kap ali »majhno« možgansko kap.
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).
≥ 25 % se je pri dolgoročni izpostavljenosti bolnikov (vsaj 48 tednov) pojavljalo zelo pogosto (v 64,4 %, 31,7 % in 12,3 %).
Not all pack sizes may be marketed
Na trgu ni vseh navedenih pakiranj.
Paediatric population Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Pediatrična populacija Olanzapin ni indiciran za zdravljenje otrok in mladostnikov mlajših od 18 let.
Dizziness Akathisia 6
Omotica Akatizija6
Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death;; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains and prolonged and/or painful erection.
Redki neželeni učinki (lahko prizadenejo do 1 od 1.000 bolnikov) vključujejo znižanje normalne telesne temperature, motnje srčnega ritma, nenadno nerazložljivo smrt, vnetje trebušne slinavke, ki povzroča hude bolečine v predelu želodca, zvišano telesno temperaturo in slabost, obolenje jeter, ki se kaže kot obarvanje kože in beločnic na rumeno, mišične bolezni, ki se kažejo kot nerazložljive bolečinske težave in bolečine, podaljšano in/ali bolečo erekcijo.
There is a risk of feeling drowsy when you are given Olazax Disperzi.
Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo Olazax Disperzi, počutili zaspane.
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 %).
13 S kratkoročnim zdravljenjem (srednje trajanje 22 dni) povezano povečanje telesne mase za ≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), za ≥ 15 % pogosto (7,1 %) in za ≥ 25 %
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.
(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.
The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Parkinsonova bolezen Uporaba olanzapina pri zdravljenju psihoze, povezane z dopaminskimi agonisti, pri bolnikih s
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 (diskinezijo), zaprtje, suha usta, izpuščaj, izgubo moči, hudo utrujenost, zadrževanje vode, ki vodi v otekanje rok, gležnjev ali nog, vročino, bolečine v sklepih ter spolne disfunkcije, kot na primer zmanjšan libido pri moških in ženskah ter erektilna disfunkcija pri moških.
Weight should be monitored regularly e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter .
Redno moramo spremljati telesno maso, npr. na začetku, 4, 8 in 12 tednov po začetku jemanja olanzapina in nato enkrat na tri mesece.
This leaflet was last revised in {MM/YYYY}.
DATUM ZADNJE REVIZIJE BESEDILA {MM/LLLL}
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors.
V predkliničnih študijah je olanzapin pokazal razpon afinitet do receptorjev (Ki; < 100 nM) za serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamin D1, D2, D3, D4, D5; holinergičnih muskarinskih receptorjev M1-M5; adrenergičnih α1; in histaminskih H1 receptorjev.
28 orodispersible tablets
28 orodisperzibilnih tablet 56 orodisperzibilnih tablet
With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Pri dolgoročni izpostavljenosti (najmanj 24 tednov) jih je 89,4 % pridobilo ≥ 7 %,
The following symptoms may occur in newborn babies, of mothers that have used Olazax Disperzi in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness,
Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo Olazax Disperzi,
What Olazax Disperzi looks like and contents of the pack
Izgled zdravila Olazax Disperzi in vsebina pakiranja
5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
5Opazovano pri osnovnih normalnih ravneh na tešče (< 1,69 mmol/l), ki so se povišale na visoke
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
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)
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 % verses 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 %).
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
How to take Olazax Disperzi
Kako jemati zdravilo Olazax Disperzi
If you suddenly stop taking Olazax Disperzi, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Če nenadno prenehate jemati zdravilo Olazax Disperzi, se lahko pojavijo simptomi, kot so znojenje,
A mass balance study showed that approximately 57 % of radiolabelled olanzapine appeared in urine, principally as metabolites.
radioaktivno označenega olanzapina pojavi v urinu, predvsem v obliki metabolitov.
If you stop taking Olazax Disperzi
Če ste pozabili vzeti zdravilo Olazax Disperzi
- If you get any side effects talk to your doctor or pharmacist.
- Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
3Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke
Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] 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.
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.
Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
(vključno s pljučno embolijo in globoko vensko trombozo) (glejte poglavje
Parkinson's disease
Parkinsonovo boleznijo ni priporočena.
What Olazax Disperzi contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg olanzapine
- Ena tableta vsebuje 5 mg, 7,5 mg, 10 mg, 15 mg ali 20 mg olanzapina.
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).. A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Občasno ( ≥ 0.1% in < 1%) so poročali o občasnih povezavah med zdravljenjem z olanzapinom in vensko tromboembolijo.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 7.5 mg olanzapine.
Ena orodisperzibilna tableta vsebuje 7,5 mg olanzapina.
6.6 Special precautions for disposal
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Glenmark Pharmaceuticals s.r.o.
NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 7.5 mg orodispersible tablets
IME ZDRAVILA Olazax Disperzi 7,5 mg orodisperzibilne tablete
Crospovidone
Glikozurija
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.
Občasni neželeni učinki (lahko prizadenejo do 1 od 100 bolnikov) vključujejo preobčutljivost (npr. otekanje v ustih in grlu, srbenje, izpuščaj), sladkorno bolezen ali poslabšanje sladkorne bolezni, 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,
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
eritem, vidne halucinacije ter inkontinenco urina.
Dystonia
Disartrija
PHARMACEUTICAL FORM AND CONTENTS Orodispersible Tablet 28 orodispersible tablets 56 orodispersible tablets METHOD AND ROUTE(S) OF ADMINISTRATION The tablet should be dissolved in the mouth or in a drink.
FARMACEVTSKA OBLIKA IN VSEBINA orodisperzibilna tableta 28 orodisperzibilnih tablet 56 orodisperzibilnih tablet
Olazax Disperzi 5 mg is supplied as a yellow coloured circular flat beveled edge orodispersible tablet with ‘B' debossed on one side.
Olazax Disperzi 5 mg je na voljo kot rumena, okrogla, ploščata tableta z zaobljenim robom in oznako
MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
IMETNIK DOVOLJENJA ZA PROMET Glenmark Pharmaceuticals s.r.o.
How to store Olazax Disperzi
Shranjevanje zdravila Olazax Disperzi
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17-< 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 5,17 mmol/l - < 6,2 mmol/l) na visoke (≥ 6,2 mmol/l).
High Gamma Glutamyltransferase10 High uric acid 10
Visoka raven gamaglutamiltransferaz e10
Skin and subcutaneous tissue disorders Rash
Bolezni kože in podkožja
Blood and the lymphatic system disorders Eosinophilia
Bolezni krvi in limfatičnega sistema
(including oculogyration)11
(vključno z okulogiracijo) 11 Tardivne diskinezije11
New born infants exposed to antipsychotics (including olanzapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
(vključno z olanzapinom), obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, katerih jakost in čas trajanja po porodu sta lahko različna.
INFORMATION IN BRAILLE Olazax Disperzi 7.5 mg orodispersible tablets 17.
PODATKI V BRAILLOVI PISAVI Olazax Disperzi 7,5 mg orodisperzibilne tablete
Excipient with known effect: Each orodispersible tablet contains 0.69 mg aspartame For the full list of excipients see section 6.1
Pomožne snov z znanim učinkom : Ena orodisperzibilna tableta vsebuje 0,69 mg aspartama.
METHOD AND ROUTE(S) OF ADMINISTRATION The tablet should be dissolved in the mouth or in a drink.
Tableto raztopite v ustih ali pijači.
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.