FrancophonIA/ELRC3.0 huggingface dataset:
English: Comparator (n=70)
Croatian: Kontrolna skupina (n=70)
English: Special precautions for use
Croatian: Posebne mjere za zbrinjavanje
English: Pixuvri 29 mg powder for concentrate for solution for infusion pixantrone
Croatian: Pixuvri 29 mg prašak za koncentrat za otopinu za infuziju piksantron
English: Uncommon: may affect up to 1 in 100 people - severe infections such as septic shock, bronchitis, pneumonia, candidiasis, cellulitis, meningitis,
Croatian: - teške infekcije poput septičkog šoka, bronhitisa, upale pluća, kandidijaze, celulitisa, meningitisa,
English: NAME OF THE MEDICINAL PRODUCT Pixuvri 29 mg powder for concentrate for solution for infusion
Croatian: NAZIV LIJEKA Pixuvri 29 mg prašak za koncentrat za otopinu za infuziju
English: Delay treatment and monitor until recovery.Consider discontinuation for persistent decline in LVEF** of ≥ 15% of baseline value.
Croatian: Razmotriti prekid terapije zbog trajnog smanjenja LVEF** za
English: Your doctor will carry out some tests before you are given Pixuvri.
Croatian: Prije nego dobijete Pixuvri, Vaš će liječnik učiniti neke pretrage.
English: Pixuvri is intended for administration as a slow intravenous infusion using an in-line filter (over a minimum of 60 minutes) only after reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection and after further dilution with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Croatian: Pixuvri je namijenjen za primjenu u obliku spore intravenske infuzije (kroz najmanje 60 minuta) uz korištenje infuzijskog filtra, ali tek nakon što je prethodno rekonstituiran dodavanjem 5 ml 0,9 %-tne otopine natrijeva klorida za injekcije (fiziološkom otopinom) te naknadno dodatno razrijeđen
English: Common Pallor, vein discolouration, hypotension Uncommon Vein disorder
Croatian: Bljedoća, promjena boje vena, hipotenzija Manje često Poremećaj vena
English: Pixuvri is an anticancer medicinal product that is harmful to cells; caution should be exercised in handling.
Croatian: Posebne mjere opreza prilikom rukovanja Pixuvri je protutumorski lijek koji može oštetiti stanice; potreban je oprez prilikom rukovanja.
English: Using sterile procedures, withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and further dilute with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Croatian: Primjenom sterilnih postupaka uvucite volumen potreban za željenu dozu (bazirano na koncentraciji od 5,8 mg/ml) i dalje razrijedite 0,9 %-tnom otopinom natrijevog klorida za injekcije do konačnog volumena od 250 ml.
English: The safety and efficacy of Pixuvri has not been established in patients with impaired renal function.
Croatian: Sigurnost i djelotvornost lijeka Pixuvri u bolesnika s oštećenom funcijom bubrega nisu ustanovljene.
English: While grade 3-4 neutropenia occurred in randomised trials more frequently among Pixuvri recipients, they were uncomplicated in the majority of cases, noncumulative and associated with a low incidence of febrile neutropenia or infections, none leading to fatal outcome.
Croatian: U većini slučajeva bila je nekomplicirana, nekumulativna i povezana s niskom incidencijom febrilne neutropenije ili infekcija, bez smrtnog ishoda.
English: Tell the person giving you the infusion immediately if you feel pain or if the injection site gets red.
Croatian: Ako osjetite bol ili se mjesto uboda zacrveni, obavijestite odmah osobu koja Vam daje infuziju.
English: How to use Pixuvri
Croatian: Kako čuvati Pixuvri
English: Using sterile procedures, reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Sterilnim postupkom rekonstituirajte svaku bočicu od 29 mg dodavanjem 5 ml 0,9 %-tne otopine natrijevog klorida (9 mg/ml) za injekcije.
English: Changes in cardiac function including decreased LVEF or fatal congestive heart failure (CHF) may occur during or after treatment with Pixuvri.
Croatian: Kardiotoksičnost Za vrijeme ili nakon liječenja lijekom Pixuvri mogu nastupiti promjene srčane funkcije uključujući sniženje LVEF ili fatalno kongestivno zatajenje srca.
English: - if you have been told that you have persistent, long-term low numbers of red blood cells, white blood cells, and platelets.
Croatian: - ako ste nedavno cijepljeni - ako Vam je rečeno da imate dugotrajno niski broj eritrocita, leukocita i trombocita.
English: Common Proteinuria, haematuria Uncommon Oliguria
Croatian: Proteinurija, hematurija
English: After a single intravenous administration of Pixuvri at 29 mg/kg and 38 mg/kg, immediate deaths were seen in mice (114 mg/m2, LD10).
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Primijećena je trenutačna smrt u miševa nakon pojedinačne intravenske primjene lijeka Pixuvri u dozama od 29 mg/kg i 38 mg/kg (114 mg/m2, LD10).
English: Pixuvri is a cytotoxic agent.
Croatian: Pixuvri je citotoksično sredstvo.
English: Common Left ventricular dysfunction, cardiac disorder, cardiac failure congestive, bundle branch block, tachycardia Uncommon Arrhythmia
Croatian: kongestivno zatajenje srca, blok grane srčanog snopa, tahikardija
English: Common Stomatitis, diarrhoea, constipation, abdominal pain,
Croatian: Stomatitis, proljev, konstipacija, abdominalna bol, suha usta, dispepsija
English: Moreover, unlike anthracyclines or anthracenediones, pixantrone directly alkylates DNA forming stable DNA adducts and cross-strand breaks.
Croatian: piksantron izravno alkilira DNK tvoreći stabilne DNK adukte i dvolančane lomove.
English: - low blood pressure - vein discolouration, pale skin - shortness of breath, cough - blood in urine - excess protein in urine - swelling of legs or ankles or other parts of the body - bone pain - chest pain - low levels of phosphate in the blood - abnormal blood test for liver or kidney function.
Croatian: - oticanje nogu i gležnjeva ili drugih dijelova tijela - koštana bol - bol u prsnom košu - niska razina fosfata u krvi - abnormalni nalazi krvnih pretraga funkcije jetre i bubrega.
English: If cardiac toxicity is demonstrated during treatment, the risk versus benefit of continued therapy with Pixuvri must be evaluated.
Croatian: Ako se tijekom liječenja pojave znakovi kardiotoksičnosti, prije nastavka terapije mora se odvagnuti odnos koristi i rizika.
English: What is in this leaflet
Croatian: Pogledajte dio 4. Što se nalazi u ovoj uputi
English: Blood uric acid levels, potassium, calcium phosphate, and creatinine should be evaluated after treatment in patients at high risk for tumour lysis (elevated LDH, high tumour volume, high baseline uric acid or serum phosphate levels).
Croatian: U bolesnika s visokim rizikom za pojavu lize tumora (povišeni LDH, tumor velikog volumena, visoka početna vrijednost mokraćne kiseline ili fosfata u serumu) potrebno je nakon terapije provjeriti razinu mokraćne kiseline, kalija, kalcija, fosfata i kreatinina u krvi.
English: Severe myelosuppression may occur.
Croatian: Može nastupiti teška mijelosupresija.
English: - If you get any side effect, talk to your doctor.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: In some trials and publications, the recommended dose is based on the salt form (pixantrone dimaleate) However, the dose has to be adjusted before the start of each cycle based on nadir haematologic counts or maximum toxicity from the preceding cycle of therapy.
Croatian: Dozu ipak treba prilagoditi prije početka svakog ciklusa liječenja na temelju najlošijih nalaza krvne slike ili maksimalne toksičnosti zabilježenih tijekom prethodnog ciklusa liječenja.
English: Slight nephropathy was induced by Pixuvri.
Croatian: Pixuvri je inducirao laganu nefropatiju.
English: Dose modification
Croatian: Prilagodba
English: One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone
Croatian: Jedna bočica sadrži količinu piksantrondimaleata koja odgovara 29 mg piksantrona.
English: Pixantrone Comparator N=70
Croatian: Piksantron Usporedni lijek N=70
English: If Pixuvri (lyophilised powder or reconstituted liquid solution) contacts the skin, wash the skin immediately and flush the membranes thoroughly with water.
Croatian: dođe u kontakt s kožom, odmah operite kožu i temeljito isperite sluznice vodom.
English: Arthralgia, arthritis, back pain, muscular weakness, musculoskeletal chest pain, musculoskeletal stiffness, neck pain, pain in extremity
Croatian: mišićno-koštana bol u prsnom košu, mišićno-koštana ukočenost, bol u vratu, bol u udovima
English: Bronchitis, candidiasis, cellulitis, herpes zoster, meningitis, nail infection, oral fungal infection, oral herpes, pneumonia, salmonella gastroenteritis, septic shock
Croatian: meningitis, infekcija noktiju, gljivična infekcija usne šupljine, herpes usne šupljine, upala pluća,
English: Upon reconstitution and dilution, this medecine contains approximately 1g (43 mmol) sodium (main component of cooking salt) per dose.
Croatian: Nakon rekonstitucije i razrjeđivanja, ovaj lijek sadrži otprilike 1 g (43 mmol) natrija (glavni sastojak kuhinjske soli) po dozi, što odgovara 50% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Reconstitute and dilute before use.
Croatian: Rekonstituirati i razrijediti prije primjene.
English: 1-2 LLN* - 50 x 10 9/l LLN - 1.0 x 10 9/l No change in dose or schedule.
Croatian: 1-2 DGN* - 50 x 109/l DGN* - 1,0 x 109/l
English: Pharmacokinetic/pharmacodynamic relationship(s) A relationship between plasma exposure to pixantrone and neutrophil count has been observed.
Croatian: Primijećena je povezanost između ekspozicije plazme piksantronu i broja neutrofila.
English: Pixantrone
Croatian: Pvrijednost
English: Pixuvri should be used with caution in patients with mild or moderate liver impairment.
Croatian: Pixuvri treba primjenjivati s oprezom u bolesnika s blago do umjereno oštećenom funkcijom jetre.
English: Pixuvri is not recommended for use in patients with severe excretory hepatic impairment, (see section 4.3).
Croatian: Pixuvri se ne preporučuje primjenjivati u bolesnika s teškim oštećenjem ekskrecijske funkcije jetre
English: The safety and efficacy of Pixuvri in children aged < 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Pixuvri u djece u dobi
English: Very common: may affect more than 1 in 10 people - nausea, vomiting - skin discolouration - thinning or loss of hair - abnormal colouration of the urine - physical weakness - low number of white blood cells, low number of red blood cells (anaemia), and low number of platelets in the blood (may require transfusion).
Croatian: - tjelesna slabost - nizak broj bijelih krvnih stanica, nizak broj crvenih krvnih stanica (anemija) i nizak broj krvnih pločica u krvi (može zahtijevati transfuziju).
English: Tabulated list of adverse reactions Adverse drug reactions (ADR) reported with Pixuvri are from final data from all completed single agent studies (n=197).
Croatian: Nuspojave zabilježene uz primjenu lijeka Pixuvri potječu iz konačnih rezultata svih dovršenih ispitivanja s jednim lijekom (n = 197) . Nuspojave su navedene u Tablici 3 prema MedDRA
English: s r.o.
Croatian: UV-A zrake.
English: Do not breast-feed while you are being treated with Pixuvri.
Croatian: Nemojte dojiti dok ste liječite lijekom Pixuvri.
English: Common Dyspnoea, cough Uncommon Pleural effusion, pneumonitis, rhinorrhoea
Croatian: Dispneja, kašalj Manje često Pleuralni izljev, pneumonitis, curenje iz nosa
English: - if you have been told that your white blood cell count is very low.
Croatian: Obratite se svom liječniku prije nego primite Pixuvri: - ako Vam je rečeno da imate vrlo nizak broj bijelih krvnih stanica.
English: NAME OF THE MEDICINAL PRODUCT Pixuvri 29 mg powder for concentrate for solution for infusion pixantrone
Croatian: Uputa o lijeku: Informacije za korisnika Pixuvri 29 mg prašak za koncentrat za otopinu za infuziju piksantron
English: Any unused medicinal product or waste material including materials used for reconstitution, dilution, and administration should be disposed of in accordance with local requirements applicable to cytotoxic agents.
Croatian: uključujući materijal korišten u rekonstituciji lijeka, njegovom razrjeđivanju i primjeni, potrebno je zbrinuti sukladno nacionalnim propisima koji se odnose na citotoksične tvari.
English: How Pixuvri is given
Croatian: Kako se primjenjuje Pixuvri
English: 6 cycles.
Croatian: 28. dana.
English: Uncommon Esophagitis, oral paresthesia, rectal haemorrhage
Croatian: Manje često Ezofagitis, oralna parestezija, krvarenje iz rektuma
English: In the study PIX 301, decreased ejection fraction occurred in 13 patients (19.1%) in the Pixuvri group.
Croatian: U ispitivanju PIX 301, u skupini koja je primala Pixuvri smanjena ejekcijska frakcija pojavila se u
English: Any unused medicinal product or waste material, including materials used for reconstitution, dilution, and administration should be disposed of in accordance with local requirements.
Croatian: uključujući materijal korišten u pripremi lijeka, njegovom razrjeđivanju i primjeni, potrebno je zbrinuti sukladno nacionalnim propisima.
English: Aseptically reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Na aseptički način rekonstituirajte svaku bočicu od 29 mg s 5 ml 0,9 %-tne otopine natrijevog klorida
English: Polyethersulfone 0.2 µm pore size in-line filters should be used during administration of the diluted Pixuvri solution.
Croatian: Za vrijeme primjene razrijeđene otopine lijeka Pixuvri treba koristiti infuzijski filter s veličinom pora od 0,2 µm od polietersulfona.
English: If on day 1 of any cycle the Absolute Neutrophil Count (ANC) is < 1.0 x 109/l or platelet count is
Croatian: Ako je na 1. dan bilo kojeg ciklusa liječenja apsolutni broj neutrofila (ABN) < 1,0 x 109/l, ili je broj trombocita < 75 x 109/l preporučuje se liječenje odgoditi dok se apsolutni broj neutrofila ne popravi do ≥ 1,0 x 109/l, a broj trombocita do ≥ 75 x 109/l.
English: In-use storage conditions
Croatian: POPIS POMOĆNIH TVARI
English: Mantle cell lymphoma patients were not included in the pivotal study.
Croatian: Bolesnici s limfomom plaštene zone (engl. mantle cell lymphoma
English: Repeated MUGA scan or ECHO determinations of LVEF should be considered in patients with risk factors such as high cumulative exposure to prior anthracyclines or significant pre-existing cardiac disease.
Croatian: U bolesnika s faktorima rizika kao što su kumulativna ekspozicija ranijim primjenama antraciklina ili postojanje klinički značajne srčane bolesti, potrebno je razmotriti potrebu ponovnog utvrđivanja stanja LVEF-a pomoću
English: How much of Pixuvri is given
Croatian: Koliko se lijeka Pixuvri primjenjuje
English: Common Erythema, nail disorder, pruritus Uncommon Night sweats, petechiae, rash macular, skin ulcer
Croatian: Noćno znojenje, petehije, makularni osip, kožni vrijedovi
English: Amitriptyline, haloperidol, clozapine, ondansetron and propranolol are metabolised by CYP1A2, and therefore, a theoretical concern exists that co-administration of Pixuvri may increase blood levels of this medicinal product.
Croatian: Amitriptilin, haloperidol, klozapin, ondansetron i propranolol metaboliziraju se pomoću CYP1A2,
English: Reduce the dose by 20%.
Croatian: ≥ 15% od početnih vrijednosti.
English: Fertility
Croatian: Piksantron
English: End-of-Study
Croatian: Na kraju ispitivanja
English: Event (PD or death) Median PFS (months) 5.3 (2.3, 6.2)
Croatian: Događaj (progresija bolesti ili smrt) Medijan preživljenja bez progresije bolesti (mjeseci)
English: < 75 x 109/l it is recommended to delay treatment until ANC recovers to ≥ 1.0 x 109/l and platelet count to ≥ 75 x 109/l.
Croatian: Odgoditi primjenu do oporavka broja trombocita ≥ 50 x 109/l i ABN** ≥ 1,0 x 109/l Smanjiti dozu za 20%.
English: Common Fatigue, mucosal inflammation, pyrexia, chest pain,
Croatian: Umor, upala sluznica, pireksija, bol u prsnom košu, edem
English: What Pixuvri is and what it is used for What you need to know before you use Pixuvri How to use Pixuvri
Croatian: Kako ćete primati Pixuvri Moguće nuspojave Kako čuvati Pixuvri
English: The active substance is pixantrone.
Croatian: - Djelatna tvar je piksantron.
English: Very common Asthenia
Croatian: Posebne skupine bolesnika
English: (listed in section 6).
Croatian: (vidjeti dio 4.3).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains pixantrone dimaleate equivalent to 29 mg pixantrone.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži količinu piksantrondimaleata koja odgovara 29 mg piksantrona.
English: Neutropenia, leukopenia, lymphopenia, anaemia, thrombocytopenia Common Febrile neutropenia, blood disorder Uncommon Bone marrow failure, eosinophilia
Croatian: Vrlo često Neutropenija, leukopenija, limfopenija, anemija, trombocitopenija
English: Renal impairment
Croatian: Učestalost Nuspojave
English: The Fisher exact test was used to compare proportions in the Pixuvri and comparator chemotherapeutic groups.
Croatian: Za usporedbu odnosa u skupini liječenih lijekom Pixuvri i kontrolnoj skupini liječenih drugim kemoterapeutikom korišten je Fischerov egzaktni test.
English: Invented name Strength Pharmaceutical Form Route of administration
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: Content (concentration) Package size
Croatian: Sadržaj (koncentracija)
English: Packaging
Croatian: Veličina pakiranja
English: 1 vial
Croatian: Put primjene Unutarnje pakiranje
English: It is available as tablets (5, 7.5 10, 15 and 20 mg).
Croatian: Dostupan je kao tablete (5, 7,5, 10, 15 i 20 mg).
English: Olazax olanzapine
Croatian: Olazax olanzapin
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Croatian: Poznat je pod nazivom „atipičan” antipsihotik jer se razlikuje od starijih antipsihotika koji su dostupni od 1950.-ih.
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Croatian: Shizofrenija je mentalna bolest koja se očituje nizom sindroma, uključujući neorganizirano razmišljanje i govor, halucinacije (bolesnici čuju ili vide nešto čega nema), sumnje i iluzije (pogrešna vjerovanja).
English: Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Croatian: Točan mehanizam djelovanja nije poznat, no vezuje se na nekoliko receptora na površini živčanih stanica u mozgu.
English: The dose is adjusted according to how well the patient responds to and tolerates the treatment.
Croatian: Doza se prilagođava ovisno o tome koliko dobro bolesnik odgovara na i podnosi terapiju.
English: The recommended starting dose of Olazax depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Croatian: Preporučena početna doza Olazax ovisi o bolesti koja se liječi: 10 mg na dan koristi u liječenju shizofrenije i prevenciji epizoda manije, a 15 mg na dan koristi se u liječenju epizoda manije, osim ako se ne koristi zajedno s drugim lijekovima, te u tom slučaju početna doza može biti 10 mg na dan.
English: Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Croatian: Bolesnici stariji od 65 godina i bolesnici koji imaju problema s jetrom ili bubrezima trebaju započeti terapiju s dozom manjom od 5 mg na dan.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Croatian: Ovo ometa signale koji se šalju između stanica mozga od strane „neurotransmitera”, kemikalija koje omogućuju međusobnu komunikaciju živčanih stanica.
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Croatian: Može se također koristiti za sprječavanje ponovnog pojavljivanja ovih epizoda (ako se simptomi ponovno pojave) u odraslih osoba s bipolarnim poremećajem (mentalnom bolesti koja uzrokuje izmjenjujuća razdoblja dobrog raspoloženja i depresije) koji su pokazali početni odgovor na liječenje.
English: Olazax is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Croatian: Olazax je također djelotvoran u održavanju poboljšanja u bolesnika koji su pokazali početni odgovor na liječenje.
English: Other information about Olazax
Croatian: Druge informacije o Olazax
English: The full EPAR for Olazax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Olazax nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva lijeka su bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olazax.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke u vezi s uvjetima za uporabu lijeka Olazax.
English: This means that Olazax is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Croatian: To znači da je Olazax sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Zyprexa.
English: Olazax is a ‘generic medicine'.
Croatian: Olazax je „generički lijek”.
English: This is a summary of the European public assessment report (EPAR) for Olazax.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Olazax.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olazax on 11 December 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Olazax vrijedi na prostoru Europske unije od 11. prosinca 2009.
English: Olazax is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Croatian: Olazax je indiciran za liječenje umjerenih do teških epizoda manije (ekstremno dobrog raspoloženja) u odraslih osoba.
English: What is Olazax?
Croatian: Što je Olazax?
English: Because Olazax is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Croatian: Budući da je Olazax generički lijek te je bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The CHMP concluded that, in accordance with EU requirements, Olazax has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Croatian: CHMP je zaključio kako je, u skladu s preduvjetima EU-a, potvrđeno kako Olazax posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Zyprexa.
English: What are the benefits and risks of Olazax shown during the studies?
Croatian: Koje su koristi i rizici lijeka Olazax?
English: The active substance in Olazax, olanzapine, is an antipsychotic medicine.
Croatian: Djelatna tvar lijeka Olazax, olanzapin, je antipsihotik.
English: Olazax is a medicine containing the active substance olanzapine.
Croatian: Olazax je lijek koji sadrži djelatnu tvar olanzapin.
English: The Committee recommended that Olazax be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Olazax.