natgillin/translations-raw huggingface dataset:
The metabolism of olanzapine may be induced by smoking. 
Kajenje lahko sproži presnavljanje olanzapina.
EU/1/08/475/012 
EU/1/08/475/011 EU/1/08/475/012
BOTTLE LABEL AND CARTON LABEL 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAKA NA PLASTENKI IN ŠKATLI
What Olanzapine Mylan contains 
Kaj vsebuje zdravilo Olanzapin Mylan
Each film-coated tablet contains 244 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 244 mg laktoze (kot monohidrat).
• Seizures 
• krče
PHARMACEUTICAL FORM AND CONTENTS 35 film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA Filmsko obložene tablete 100 filmsko obloženih tablet
13.4 mm x 7.3 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 20” on one side and “G” on the other side. 
Olanzapin Mylan 20 mg filmsko obložene tablete 13,4 mm × 7,3 mm, elipsaste, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ 20” na eni strani in “G” na drugi strani.
Each film-coated tablet contains 152 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 152 mg laktoze (kot monohidrat).
Olanzapine Mylan 20 mg are oval-shaped, white film-coated tablets with sides that curve outwards, marked with “OZ 20” on one side and “G” on the other side. 
Zdravilo Olanzapin Mylan 20 mg so ovalne, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z“OZ 20” na eni strani in “G” na drugi strani.
Olanzapine Mylan 7.5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 7.5” on one side and “G” on the other side. 
Zdravilo Olanzapin Mylan 7,5 mg so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 7.5” na eni strani in “G” na drugi strani.
Olanzapine Mylan 7.5 mg film-coated tablets 
Olanzapin Mylan 7,5 mg filmsko obložene tablete
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 7.5 mg olanzapine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 7,5 mg olanzapina.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17-< 6.2 mmol) to high (≥ 6.2 mmol) 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).
The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin. 
Filmska obloga ene 15 mg tablete vsebuje 0,15 mg sojinega lecitina.
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly. 
7 Pri nenadni prekinitvi zdravljenja z olanzapinom so poročali o akutnih simptomih kot so znojenje, nespečnost, tresenje, tesnoba, slabost in bruhanje.
Olanzapine Mylan 15 mg film-coated tablets Each film-coated tablet contains 15 mg olanzapine. 
Olanzapin Mylan 15 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 15 mg olanzapina.
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 2.5 mg olanzapine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 2,5 mg olanzapina.
Discontinuation symptoms7, 12 
Nevroleptični maligni sindrom (glejte poglavje 4.4)12 Odtegnitveni simptomi7, 12
Olanzapine Mylan 10 mg film-coated tablets Each film-coated tablet contains 10 mg olanzapine. 
Olanzapin Mylan 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg olanzapina.
Olanzapine Mylan 2.5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 2.5” on one side and “G” on the other side. 
Zdravilo Olanzapin Mylan 2,5 mg, so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 2.5” na eni strani in “G” na drugi strani.
Olanzapine Mylan 5 mg film-coated tablets Each film-coated tablet contains 5 mg olanzapine. 
Olanzapin Mylan 5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 5 mg olanzapina.
Patients with known risk of narrow-angle glaucoma. 
Bolniki z ugotovljenim tveganjem za glavkom z zaprtim zakotjem.
Olanzapine Mylan 2.5 mg film-coated tablets 
Olanzapin Mylan 2,5 mg filmsko obložene tablete
The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin. 
Filmska obloga ene 5 mg tablete vsebuje 0,12 mg sojinega lecitina.
Olanzapine Mylan 10 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 10” on one side and “G” on the other side. 
Zdravilo Olanzapin Mylan 10 mg so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 10” na eni strani in “G” na drugi strani.
This will usually pass on its own but if it does not, tell your doctor. 
V kolikor ne izzveni spontano, obvestite zdravnika.
Olanzapine Mylan 20 mg film-coated tablets 
Olanzapin Mylan 20 mg filmsko obložene tablete olanzapin
12.2 mm x 6.7 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 15” on one side and “G” on the other side. 
Olanzapin Mylan 15 mg filmsko obložene tablete 12,2 mm × 6,7 mm, elipsaste, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ 15” na eni strani in “G” na drugi strani.
9.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “7.5” on one side and “G” on the other side. 
9,0 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “7.5” na eni strani in “G” na drugi strani.
Olanzapine Mylan 15 mg are oval-shaped, white film-coated tablets with sides that curve outwards, marked with “OZ 15” on one side and “G” on the other side. 
Zdravilo Olanzapin Mylan 15 mg so ovalne, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z“OZ 15” na eni strani in “G” na drugi strani.
8.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “5” on one side and “G” on the other side. 
8,0 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “5” na eni strani in “G” na drugi strani.
7.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “2.5” on one side and “G” on the other side. 
7,0 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “2.5” na eni strani in “G” na drugi strani.
10.2 mm, round, normal convex, white film-coated tablets debossed “OZ” over “10” on one side and “G” on the other side. 
10,2 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “10” na eni strani in “G” na drugi strani.
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%). 
Zelo redko (≥ 0.1 % in < 1 %) so poročali o občasnih povezavah med zdravljenjem z olanzapinom in vensko tromboembolijo.
Tabulated list of adverse reactions 
Tabela neželenih učinkov
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg olanzapine. 
NAVEDBA ELE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 20 mg olanzapina.
Olanzapine Mylan 10 mg film-coated tablets 
Olanzapin Mylan 10 mg filmsko obložene tablete
Olanzapine Mylan 5 mg film-coated tablets 
Olanzapin Mylan 5 mg filmsko obložene tablete
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 15 mg olanzapine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 15 mg olanzapina.
Olanzapine Mylan 5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 5” on one side and “G” on the other side. 
Zdravilo Olanzapin Mylan 5 mg, so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 5” na eni strani in “G” na drugi strani.
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 5 mg olanzapine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 5 mg olanzapina.
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg olanzapine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg olanzapina.
Olanzapine Mylan 15 mg film-coated tablets 
Olanzapin Mylan 15 mg filmsko obložene tablete olanzapin
Bottles 
Plastenka
MARKETING AUTHORISATION NUMBER EU/1/08/475/052 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/052
MARKETING AUTHORISATION NUMBER EU/1/08/475/017 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/017
MARKETING AUTHORISATION NUMBER EU/1/08/475/048 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/048
MARKETING AUTHORISATION NUMBERS EU/1/08/475/029 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/029
NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 2.5 mg film-coated tablets olanzapine 
Olanzapin Mylan 2,5 mg filmsko obložene tablete olanzapin
MARKETING AUTHORISATION NUMBER EU/1/08/475/049 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/049
NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 7.5 mg film-coated tablets olanzapine 
Olanzapin Mylan 7,5 mg filmsko obložene tablete olanzapin
MARKETING AUTHORISATION NUMBER EU/1/08/475/050 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/050
MARKETING AUTHORISATION NUMBER EU/1/08/475/047 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/047
MARKETING AUTHORISATION NUMBERS EU/1/08/475/034 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/034
General disorders and administration site conditions Asthenia 
Splošne težave in spremembe na mestu aplikacije Astenija
Seizures have been reported to occur uncommonly in patients when treated with olanzapine. 
Pri bolnikih, ki so se zdravili z olanzapinom, so o epileptičnih napadih poročali občasno.
Metabolism and nutrition disorders Weight gain1 Elevated cholesterol levels2,3 
Presnovne in prehranske motnje Povečanje telesne mase1
Patients should be advised not to breast feed an infant if they are taking olanzapine. 
Če jemljejo olanzapin, naj se bolnicam dojenje dojenčka odsvetuje.
NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 10 mg film-coated tablets olanzapine 
Olanzapin Mylan 10 mg filmsko obložene tablete olanzapin
High Uric Acid10 
Visoke vrednosti sečne kisline10
NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 5 mg film-coated tablets olanzapine 
Olanzapin Mylan 5 mg filmsko obložene tablete olanzapin
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2008 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
23 May 2014 
23. maj 2014
The company also presented various supporting analyses and information from a supportive study. 
Družba je predstavila tudi različne podporne analize in informacije iz podporne študije.
For more information, see here. 
Več informacij je na voljo tukaj.
In addition, some concerns about the quality of the medicine were not yet resolved. 
Poleg tega niso bili razrešeni nekateri zadržki glede kakovosti zdravila.
It was to be available as tablets. 
Na voljo naj bi bilo v obliki tablet.
The main measure of effectiveness was how long the patients survived with their disease. 
Glavno merilo učinkovitosti je bil čas preživetja bolnikov z boleznijo.
Although the company presented analyses suggesting that there was a benefit in a subgroup of patients with certain genetic changes associated with more aggressive disease, and in a subgroup of patients with pain, the study was not designed to show benefit in these smaller groups, and the Committee considered that further study would be needed to demonstrate such a benefit. 
Čeprav je družba predstavila analize, ki nakazujejo na koristi v podskupini bolnikov z določenimi genetskimi spremembami, povezanimi z agresivnejšo boleznijo, in v podskupini bolnikov z bolečinami, študija ni bila zasnovana za prikaz koristi v teh manjših skupinah, zato je Odbor menil, da bi bila za dokaz te koristi potrebna dodatna študija.
This means that it blocks certain enzymes known as tyrosine kinases. 
To pomeni, da zavira določene encime, imenovane tirozin-kinaze.
The effects of Masiviera were first tested in experimental models before being studied in humans. 
Učinki zdravila Masiviera so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In addition, Masiviera was associated with significant toxicity. 
Poleg tega je bilo zdravilo Masiviera povezano s pomembno toksičnostjo.
The company presented results of one main study involving 353 patients with advanced or metastatic pancreatic cancer. 
Družba je predstavila rezultate ene glavne študije, v katero je bilo vključenih 353 bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
During the re-examination the CHMP looked again at the data from the company, including a proposal for a conditional authorisation in a restricted group of patients, and also consulted a group of experts in the treatment of pancreatic cancer. 
Med ponovnim pregledom je odbor CHMP znova pregledal podatke družbe, vključno s predlogom za pogojno odobritev pri omejeni skupini bolnikov, in se prav tako posvetoval s skupino strokovnjakov za zdravljenje raka trebušne slinavke.
Refusal of the marketing authorisation for Masiviera (masitinib) 
Zavrnitev vloge za dovoljenje za promet z zdravilom Masiviera (masitinib)
Furthermore, the CHMP had concerns about the quality of the product, in particular about the impurities to which patients might be exposed and about whether commercial batches of the medicine would have the same quality as those used for the studies. 
Nadalje je imel pomisleke glede kakovosti zdravila, še zlasti glede nečistoč, ki bi jim lahko bili izpostavljeni bolniki, in ali bi bila kakovost komercialnih serij zdravila enaka kakovosti serij, ki so jih uporabili za študije.
What is Masiviera? 
Kaj je zdravilo Masiviera?
By blocking these receptors, Masiviera might help in controlling cell division and thereby slow down the growth of the cancer. 
receptorjev lahko zdravilo Masiviera pomaga pri nadzorovanju celične delitve ter s tem upočasni rast raka.
It was to be used in combination with another cancer medicine, gemcitabine. 
Zdravilo naj bi se uporabljalo v kombinaciji z drugim zdravilom proti raku, tj. gemcitabinom.
Refusal of the marketing authorisation for Masiviera (masitinib) EMA/327117/2014 
Zavrnitev vloge za dovoljenje za promet z zdravilom Masiviera (masitinib) EMA/298222/2014
Masitinib was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2009 for the treatment of pancreatic cancer. 
Zdravilo Masitinib je bilo 28. oktobra 2009 določeno kot „zdravilo sirota‟ (zdravilo, ki se uporablja pri redkih boleznih) za zdravljenje raka trebušne slinavke.
Therefore, the CHMP concluded that the benefits of Masiviera did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation. 
Zato je zaključil, da koristi zdravila Masiviera niso večje od z njim povezanih tveganj, in ostal pri svojem prejšnjem priporočilu, da se zanj zavrne izdaja dovoljenja za promet.
The company that applied for authorisation is AB Science. 
Vlogo za pridobitev dovoljenja je predložila družba AB Science.
uncontrollably. 
Z zaviranjem teh
At the time of the initial evaluation, the CHMP noted that the results of the main study with Masiviera did not show effectiveness in the overall group of patients with advanced or metastatic pancreatic cancer. 
V času prvotne ocene je odbor CHMP zabeležil, da rezultati glavne študije z zdravilom Masiviera niso pokazali učinkovitosti zdravila pri splošni skupini bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masiviera, intended for the treatment of advanced inoperable pancreatic cancer. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je 23. januarja 2014 sprejel negativno mnenje, s katerim je priporočil zavrnitev izdaje dovoljenja za promet z zdravilom Masiviera, namenjenim za zdravljenje napredovalega raka trebušne slinavke, ki ga ni mogoče kirurško odstraniti.
Masiviera was expected to be used to treat adults with cancer of the pancreas (an organ of the digestive system) that is locally advanced or metastatic (has spread to other parts of the body), nonresectable (unsuitable for surgery) and is accompanied by at least moderate pain. 
Zdravilo Masiviera naj bi se uporabljalo za zdravljenje odraslih z neodstranljivim (neprimernim za kirurški poseg), lokalno napredovalim ali metastatskim (razširjenim na druge dele telesa) rakom trebušne slinavke (organa prebavnega sistema), ki ga spremlja najmanj zmerna bolečina.
The Committee confirmed its opinion that the effectiveness of Masiviera had not been sufficiently demonstrated in pancreatic cancer. 
Potrdil je svoje mnenje, da učinkovitost zdravila Masiviera ni bila zadovoljivo dokazana pri raku trebušne slinavke.
The active substance in Masiviera, masitinib, is a tyrosine-kinase inhibitor. 
Zdravilna učinkovina zdravila Masiviera, masitinib, je zaviralec tirozin-kinaze.
These enzymes can be found in some receptors on the surface of cells, including the receptors that are involved in stimulating cancer cells to divide 
Ti encimi so na nekaterih receptorjih na površini celic, med drugim tudi na receptorjih, ki pospešujejo nenadzorovano deljenje rakavih celic.
The company informed the CHMP that there were no consequences for patients in clinical trials or compassionate use programmes. 
Družba je odbor CHMP obvestila, da zavrnitev nima nobenih posledic za bolnike v kliničnih preskušanjih ali programih sočutne uporabe.
What was Masiviera expected to be used for? 
Za kaj naj bi se zdravilo Masiviera uporabljalo?
Masiviera is an anticancer medicine that contains the active substance masitinib. 
Masiviera je zdravilo proti raku, ki vsebuje zdravilno učinkovino masitinib.
How is Masiviera expected to work? 
Kako naj bi zdravilo Masiviera delovalo?
Masiviera was compared with placebo (a dummy treatment) as an addition to treatment with gemcitabine. 
V njej so primerjali zdravilo Masiviera in placebo (zdravilo brez zdravilne učinkovine), ki so ju dodajali gemcitabinu.
Pharmaceutical Form Route of administration Packaging 
Farmacevtska oblika Pot uporabe
(Invented) name Strength Pharmaceutical form Route of administration 
Jakost Farmacevtska oblika
MA EU Number 
Številka (EU) dovoljenja za promet
Further information on Rxulti can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije za zdravilo Rxulti so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (seeing, hearing or feeling things that are not there). 
Shizofrenija je duševna bolezen s simptomi, kot so blodnje, neorganizirano mišljenje in govor, sumničavost in halucinacije (bolnik vidi, sliši ali čuti stvari, ki jih ni).
In patients with moderately or severely reduced kidney or liver function the dose should be limited to 3 mg once a day. 
Pri bolnikih z zmerno ali močno zmanjšano ledvično ali jetrno funkcijo je treba odmerek omejiti na 3 mg enkrat na dan.
In patients taking certain other medicines the doctor may need to adjust the dose of Rxulti. 
Pri bolnikih, ki jemljejo nekatera druga zdravila, bo moral zdravnik morda prilagoditi odmerek zdravila Rxulti.
The recommended starting dose is 1 mg once daily for the first 4 days. 
Priporočeni začetni odmerek je 1 mg enkrat na dan prve štiri dni.
What measures are being taken to ensure the safe and effective use of Rxulti? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rxulti?
The Agency decided that Rxulti's benefits are greater than its risks and it can be authorised for use in the EU. 
Agencija je zaključila, da so koristi zdravila Rxulti večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Although the reductions in symptoms were not consistent across the studies, this often occurs in studies with antipsychotic medicines and the European Medicines Agency considered that the effects were sufficient to conclude that Rxulti is beneficial to patients with schizophrenia. 
Čeprav je bilo med študijami mogoče opaziti neskladja glede zmanjšanja simptomov, se to pogosto dogaja v študijah z antipsihotičnimi zdravili, zato je Evropska agencija za zdravila menila, da so učinki zadostni za ugotovitev, da je zdravilo Rxulti koristno za bolnike s shizofrenijo.
The active substance in Rxulti, brexpiprazole, is thought to attach to receptors (targets) in the brain for several neurotransmitters (substances nerve cells use to communicate with neighbouring cells) including dopamine, serotonin and noradrenaline. 
Učinkovina v zdravilu Rxulti, brekspiprazol, naj bi se vezala na (ciljne) receptorje v možganih za več živčnih prenašalcev (snovi, ki jih uporabljajo živčne celice za komunikacijo s sosednjimi celicami), vključno z dopaminom, serotoninom in noradrenalinom.
The safety profile of Rxulti is similar to other antipsychotic medicines. 
Varnostni profil zdravila Rxulti je podoben kot pri drugih antipsihotičnih zdravilih.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rxulti have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rxulti upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Rxulti are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Rxulti, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Rxulti are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rxulti stalno spremljajo.
Why is Rxulti authorised in the EU? 
Zakaj je bilo zdravilo Rxulti odobreno v EU?
For more information about using Rxulti, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Rxulti glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Rxulti and why it is authorised in the EU 
Pregled zdravila Rxulti in zakaj je odobreno v EU
Rxulti is an antipsychotic medicine used to treat schizophrenia in adults. 
Rxulti je antipsihotično zdravilo, ki se uporablja za zdravljenje shizofrenije pri odraslih.
In 4 of the studies, Rxulti was compared with placebo (a dummy treatment) and the main measure of effectiveness was reduction of symptoms on a standard rating scale called PANSS (positive and negative syndrome scale) which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms) after 6 weeks of treatment. 
V štirih študijah so zdravilo Rxulti primerjali s placebom (zdravilom brez učinkovine), pri čemer je bilo glavno merilo učinkovitosti zmanjšanje simptomov na standardni ocenjevalni lestvici PANSS (lestvici za ocenjevanje pozitivnega in negativnega sindroma), ki sega od najmanj 30 (brez simptomov) do največ 210 (najresnejši simptomi) po šestih tednih zdravljenja.
Based on available data, it is not possible to say how Rxulti compares with other medicines of the same type. 
Na podlagi podatkov, ki so na voljo, ni mogoče napovedati, kako učinkovito je zdravilo Rxulti v primerjavi z drugimi zdravili enake vrste.
Other information about Rxulti 
Druge informacije o zdravilu Rxulti
Rxulti is available as tablets (0.25, 0.5, 1, 2, 3 and 4 mg) to be taken by mouth. 
Zdravilo Rxulti je na voljo v obliki tablet (0,25 mg, 0,5 mg, 1 mg, 2 mg, 3 mg in 4 mg), ki se jemljejo peroralno.
What benefits of Rxulti have been shown in studies? 
Kakšne koristi zdravila Rxulti so se pokazale v študijah?
Rxulti was more effective than placebo in preventing relapse: after a year, 14% of patients taking Rxulti had relapsed compared with 38% of patients taking placebo. 
Zdravilo Rxulti se je v primerjavi s placebom izkazalo za bolj učinkovito pri preprečevanju tveganja pojava ponovitve: po enem letu se je ponovitev pojavila pri 14 % bolnikov, ki so jemali zdravilo Rxulti, v primerjavi z 38 % bolnikov, zdravljenih s placebom.