FrancophonIA/ELRC3.0 huggingface dataset:
English: Kern Pharma, S.L.
Croatian: Kern Pharma, S.L. Venus, 72.
English: United Kingdom Ennogen Limited 78 York Street
Croatian: Ennogen Limited 78 York Street London W1H 1DP United Kingdom
English: United Kingdom Hameln Pharmaceuticals Limited
Croatian: Hameln Pharmaceuticals Limited
English: Modified-release capsules, hard
Croatian: Kapsula s prilagođenim oslobađanjem, tvrda
English: Limassol Industrial Estate Aharnon Street P.O.
Croatian: Limassol Industrial Estate Aharnon Street P.O. Box 51706
English: Yorkdale Industrial Park Braithwaite Street
Croatian: Rosemont House Yorkdale Industrial Park Braithwaite Street Leeds, W Yorkshire LS11 9XE
English: 01445 Radebeul
Croatian: 01445 Radebeul Germany
English: Str. Aleea Eroilor nr. 28, Vişeu de Sus, Judeţul Maramureş 435700 România
Croatian: Judeţul Maramureş 435700 Romania
English: Miles Gray Road, Basildon Essex SS14 3AF
Croatian: Amdipharm plc Regency House Miles Gray Road, Basildon Essex SS14 3AF United Kingdom
English: Slovak Republic Sandoz Pharmaceuticals d.d.
Croatian: Sandoz Pharmaceuticals d.d.
English: Oral drops, solution
Croatian: Oralne kapi, otopina
English: Oral solution betapharm Arzneimittel GmbH
Croatian: Oralna otopina betapharm Arzneimittel GmbH
English: Intravenous use
Croatian: Parenteralna uporaba
English: Şos.
Croatian: Str.
English: Prolonged-release capsule, hard
Croatian: Kapsula s produljenim oslobađanjem, tvrda
English: Metoclopramid AWD 10 mg Tabletten axcount Generika AG Max-Planck-Str. 36b D-61381 Friedrichsdorf Germany
Croatian: Metoclopramid AWD 10 mg Tabletten axcount Generika AG Max-Planck-Str.
English: Modified-release capsule, soft
Croatian: Kapsula s prilagođenim oslobađanjem, meka
English: MCP-ratiopharm SF 10mg/2ml Injektionslösung ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Croatian: MCP-ratiopharm SF 10mg/2ml Injektionslösung ratiopharm GmbH Graf-Arco-Str.
English: Teva Pharma B.V. Computerweg 10
Croatian: Teva Pharma B.V.
English: Oral drops
Croatian: Oralne kapi
English: Film-coated tablet
Croatian: Filmom obložena tableta Kroz usta
English: MCP-ratiopharm 10 mg Tabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Croatian: MCP-ratiopharm 10 mg Tabletten ratiopharm GmbH Graf-Arco-Str.
English: Middlesex HA1 3NY
Croatian: 15 Runnelfield Harrow on the Hill Middlesex HA1 3NY United Kingdom
English: România
Croatian: Rumunjska
English: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 D-53757 Sankt Augustin Germany
Croatian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
English: Czech Republic Lek Pharmaceuticals d.d.
Croatian: Češka Republika Lek Pharmaceuticals d.d. Verovškova 57
English: Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Croatian: Generica KG Südwestpark 50
English: pharma GmbH & Co.KG
Croatian: AWD. pharma GmbH & Co.KG
English: Prolonged-release capsule ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Croatian: Kapsula s produljenim oslobađanjem ratiopharm GmbH Graf-Arco-Str.
English: Long-term exposure (at least 48 weeks)
Croatian: Dugotrajna izloženost (najmanje 48 tjedana)
English: Do not stop taking your tablets just because you feel better.
Croatian: Nemojte prestati uzimati tablete samo zato jer se osjećate bolje.
English: Try to take your tablets at the same time each day.
Croatian: Pokušajte uzimati tablete svaki dan u isto vrijeme.
English: There are no adequate and well-controlled studies in pregnant women.
Croatian: Ne postoje odgovarajuća i dobro kontrolirana ispitivanja u trudnica.
English: Date of latest renewal: 22 May 2013
Croatian: Datum posljednje obnove: 22. svibnja 2013.
English: Common: Dry mouth
Croatian: Često: Suha usta
English: Do not take a double dose to make up for the forgotten tablet.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
English: Take your tablets as soon as you remember.
Croatian: Uzmite tablete čim se sjetite.
English: It does not matter whether you take them with or without food.
Croatian: Nije važno uzimate li lijek s hranom ili bez nje.
English: Some fatal cases have been reported in this particular group of patients.
Croatian: Zabilježeno je i nekoliko smrtnih slučajeva u ovoj specifičnoj skupini bolesnika.
English: Show the doctor your pack of tablets.
Croatian: Pokažite liječniku pakiranje tableta.
English: You and your doctor should check your weight regularly.
Croatian: Sa svojim liječnikom redovito provjeravajte svoju tjelesnu težinu.
English: Signs and symptoms
Croatian: Znakovi i simptomi
English: Consequently, newborns should be monitored carefully.
Croatian: Zbog toga novorođenčad treba pažljivo pratiti.
English: • Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Croatian: • Obavijestite svog liječnika ako ste Vi ili netko drugi u Vašoj obitelji u prošlosti imali krvne ugruške, budući da su lijekovi poput ovih povezani sa stvaranjem krvnih ugrušaka.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Croatian: Početna doza i raspon doze ne moraju se rutinski mijenjati za nepušače u odnosu na pušače.
English: These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Croatian: Ovi se simptomi mogu privremeno pogoršati ili čak pojaviti nakon prekida liječenja.
English: Speech disorder was also reported commonly.
Croatian: Poremećaji govora također su često zabilježeni.
English: Close medical supervision and monitoring should continue until the patient recovers.
Croatian: Pažljivi liječnički nadzor i praćenje treba nastaviti do oporavka bolesnika.
English: This will usually pass on its own but if it does not, tell your doctor.
Croatian: Ovo obično prolazi samo po sebi, ali ako ne prođe, javite se liječniku.
English: If you suffer from any of the following illnesses tell your doctor as soon as possible:
Croatian: Ako bolujete od bilo koje od sljedećih bolesti, obavijestite svog liječnika što je prije moguće:
English: Tell your doctor.
Croatian: Obavijestite svog liječnika.
English: Information on long term safety is primarily limited to open-label, uncontrolled data.
Croatian: Informacije o dugotrajnoj sigurnosti primjene ograničene su prvenstveno na podatke iz otvorenih nekontroliranih ispitivanja.
English: People with this disease may also feel depressed, anxious or tense.
Croatian: Osobe s tom bolešću mogu se osjećati depresivno, tjeskobno ili napeto.
English: • if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Croatian: • Ako od ranije imate dijagnosticirane poteškoće s očima kao što su određene vrste glaukoma (povišeni očni tlak).
English: Such factors possibly contribute to the higher average exposure observed in adolescents.
Croatian: Ti faktori moguće doprinose većoj prosječnoj izloženosti uočenoj u adolescenata.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Croatian: Liječnik Vam može savjetovati da postupno smanjujete dozu prije prekida liječenja.
English: Additional information on special populations
Croatian: Dodatne informacije o posebnim populacijama
English: In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Croatian: U ispitivanju na bijelcima, Japancima i Kinezima nisu postojale razlike u farmakokinetičkim parametrima između ove tri populacije.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Croatian: U nekim je slučajevima zabilježeno prethodno povećanje tjelesne težine što može biti predisponirajući čimbenik.
English: It is recommended that blood pressure is measured periodically in patients over 65 years.
Croatian: Preporučuje se povremeno mjerenje krvnog tlaka u bolesnika starijih od 65 godina.
English: Tell your doctor immediately if you have:
Croatian: Odmah obavijestite svog liječnika ako imate:
English: Always take this medicine exactly as your doctor has told you.
Croatian: Ovaj lijek uzimajte točno onako kako vam je propisao liječnik.
English: After first opening use within 90 days.
Croatian: Nakon prvog otvaranja iskoristiti u roku od 90 dana.
English: Patients should be closely monitored during this period.
Croatian: U tom razdoblju bolesnike treba pažljivo pratiti.
English: Your doctor will tell you how many Olanzapine Mylan tablets to take and how long you should continue to take them.
Croatian: Liječnik će Vam reći koliko tableta Olanzapine Mylan trebate uzeti i koliko ćete ih dugo uzimati.
English: Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Croatian: Olanzapin pripada skupini lijekova koji se zovu antipsihotici i koristi se za liječenje sljedećih stanja:
English: Potential interactions affecting olanzapine
Croatian: Potencijalne interakcije koje utječu na olanzapin
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Croatian: Ne postoje podaci iz kontroliranih ispitivanja o održavanju učinka ni dugotrajnoj sigurnosti (vidjeti dijelove 4.4 i 4.8).
English: A lower starting dose (5 mg) should be considered for such patients.
Croatian: Za ove se bolesnike treba razmotriti niža početna doza (5 mg).
English: Olanzapine had no teratogenic effects.
Croatian: Olanzapin nije imao teratogene učinke.
English: Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Croatian: Demografske razlike između adolescenata i odraslih obuhvaćale su manju prosječnu tjelesnu težinu i manji broj pušača adolescenata.
English: Bottles: After first opening use within 90 days.
Croatian: Boce: Nakon prvog otvaranja iskoristiti u roku od 90 dana.
English: Adolescents (ages 13 to 17 years): The pharmacokinetics of olanzapine are similar between adolescents and adults.
Croatian: Adolescenti (u dobi od 13 do 17 godina): farmakokinetika olanzapina je slična između adolescenata i odraslih.
English: Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Croatian: Potreban je oprez u bolesnika koji konzumiraju alkohol ili primaju lijekove koji mogu uzrokovati depresiju središnjeg živčanog sustava.
English: The efficacy of olanzapine was not established in these trials.
Croatian: Djelotvornost olanzapina nije utvrđena u ovim ispitivanjima.
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako se u vašeg djeteta razvije bilo koji od ovih simptoma, možda ćete se trebati obratiti svom liječniku.
English: • Medicines of this type may cause unusual movements mainly of the face or tongue.
Croatian: • Lijekovi ove vrste mogu uzrokovati pojavu neuobičajenih pokreta, uglavnom lica ili jezika.
English: Neuroleptic Malignant Syndrome (NMS)
Croatian: Neuroleptički maligni sindrom (NMS)
English: In particular, tell your doctor if you are taking:
Croatian: Obavijestite posebno svog liječnika ako uzimate:
English: An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Croatian: Povećanje doze iznad preporučene početne doze savjetuje se samo nakon odgovarajuće ponovne kliničke procjene i treba općenito nastupiti u intervalima ne kraćim od 24 sata.
English: Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Croatian: Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Velika Britanija.
English: 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.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti podnositi ako je lijek uvršten u referentni popis datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: In the majority of these patients the elevations were generally mild, and remained below two times the upper limit of normal range.
Croatian: U većine ovih bolesnika povećanja su bila općenito blaga i ostala su niža od dvostrukog povećanja gornje granice normalnog raspona.
English: Discontinuation symptoms7, 12
Croatian: simptomi ustezanja7, 12
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, prije uzimanja ovog lijeka posavjetujte se sa svojim liječnikom.
English: There is no specific antidote for olanzapine.
Croatian: Nema specifičnog antidota za olanzapin.
English: 6.2 Incompatibilities Not applicable.
Croatian: 6.2 Inkompatibilnosti
English: 16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients.
Croatian: 16 Povišene razine prolaktina u plazmi zabilježene su u 47,4 % adolescentnih bolesnika.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika traži se da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Croatian: Međutim, olanzapin (5-20 mg) je u ženskih bolesnika (n = 467) pokazao profil sigurnosti usporediv s onim u muških bolesnika (n = 869).
English: Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Međutim, budući da je iskustvo primjene u ljudi ograničeno, olanzapin se u trudnoći treba primjenjivati samo ako potencijalna korist opravdava potencijalni rizik za fetus.
English: Smokers
Croatian: Pušači
English: The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Croatian: Medijan letalnih doza bio je približno 210 mg/kg (miševi), odnosno 175 mg/kg (štakori).
English: Olanzapine can be given without regards for meals as absorption is not affected by food.
Croatian: Olanzapin se može davati bez obzira na obroke jer hrana ne utječe na apsorpciju.
English: Unlike some other antipsychotic agents, olanzapine increases responding in an “anxiolytic” test.
Croatian: Za razliku od nekih drugih antipsihotika, olanzapin povećava odgovor u „anksiolitičkom” testu.
English: In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Croatian: U 44 bolesnika sa shizofrenijom, u dobi od 65 godina, doziranje od 5 do 20 mg/dan nije bilo povezano ni sa kakvim razlikovnim profilom štetnih događaja.
English: Olanzapine is metabolised in the liver by conjugative and oxidative pathways.
Croatian: Olanzapin se metabolizira u jetri konjugacijskim i oksidacijskim putovima.
English: In clinical studies, the average olanzapine exposure was approximately 27 % higher in adolescents.
Croatian: U kliničkim ispitivanjima, prosječna izloženost olanzapinu bila je približno 27 % viša u adolescenata.
English: The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Croatian: Glavni cirkulirajući metabolit je 10-N-glukuronid, koji ne prolazi krvno-moždanu barijeru.
English: If this happens do not drive or operate any tools or machines.
Croatian: Ako se ovo dogodi, nemojte upravljati vozilima niti bilo kakvim alatima ili strojevima.
English: Dose escalation, when indicated, should be conservative in such patients (see sections 4.5 and 5.2).
Croatian: Povećanje doze, kada je indicirano, treba biti konzervativno u takvih bolesnika (vidjeti dijelove 4.5 i 5.2).
English: Perforated unit dose blisters:
Croatian: Perforirani blisteri djeljivi na jedinične doze:
English: Growth parameters were decreased at high doses.
Croatian: Pri visokim dozama bili su smanjeni parametri rasta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2008
Croatian: Datum prvog odobrenja: 7. listopada 2008.
English: • if you are allergic (hypersensitive) to olanzapine, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na olanzapin, kikiriki ili soju ili pak na druge sastojke ovog lijeka (navedene u dijelu 6).
English: Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Croatian: Na temelju rezultata ispitivanja u miševa i štakora zaključeno je da olanzapin nije karcinogen.
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Croatian: Veća incidencija smrtnosti nije bila povezana s dozom olanzapina (srednja vrijednost dnevne doze od 4,4 mg) ili trajanjem liječenja.
English: Fertility Effects on fertility are unknown (see section 5.3 for preclinical information).
Croatian: Plodnost Nisu poznati učinci na plodnost (vidjeti dio 5.3 za pretkliničke podatke).
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Croatian: Vrlo često: Sedacija (uključujući: hipersomniju, letargiju, somnolenciju).
English: However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Croatian: Međutim, veličina utjecaja dobi, spola ili pušenja na klirens i poluvrijeme olanzapina malena je u usporedbi s ukupnom varijabilnosti među pojedincima.
English: Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Croatian: Olanzapin nije bio mutagen ili klastogen u punom rasponu standardnih testova koji su uključivali testove bakterijske mutacije te in vitro i in vivo testove na sisavcima.
English: Portugal Mylan, Lda.
Croatian: Mylan, Lda.
English: Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Croatian: Olanzapin se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina zbog nedostatnih podataka o sigurnosti i djelotvornosti.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Croatian: • neuobičajene pokrete (česta nuspojava koja se može pojaviti u manje od 1 na 10 osoba) uglavnom na licu ili jeziku;
English: 117 Allée des Parcs 69800 Saint-Priest France
Croatian: 117 Allée des Parcs 69800 Saint-Priest Francuska
English: When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Croatian: Ako je prisutno više čimbenika koji mogu usporiti metabolizam (ženski spol, starija životna dob, nepušač), potrebno je razmotriti smanjenje početne doze.
English: Discontinuation of treatment
Croatian: Prekid liječenja
English: You should take your Olanzapine Mylan tablets once a day following the advice of your doctor.
Croatian: Olanzapine Mylan tablete morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.
English: Activated charcoal reduces the bioavailability of oral olanzapine by 50 % to 60 % and should be taken at least 2 hours before or after olanzapine.
Croatian: Aktivni ugljen smanjuje bioraspoloživost oralnog olanzapina za 50 do 60 % te ga treba uzeti najmanje 2 sata prije ili poslije olanzapina.
English: • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Croatian: • Umjerenih do blagih epizoda manije, stanja sa simptomima uzbuđenja ili euforije.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Croatian: Učestalost je definirana kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code: N05AH03.
Croatian: Farmakoterapijska skupina: psiholeptici, diazepini, oksazepini, tiazepini i oksepini, ATK oznaka: N05AH03.
English: Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Croatian: Olanzapin se dobro apsorbira nakon peroralne primjene, dosežući vršne koncentracije u plazmi unutar 5 do 8 sati.
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Croatian: Za poboljšanje kliničkog stanja bolesnika tijekom liječenja antipsihoticima potrebno je nekoliko dana do nekoliko tjedana.
English: Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Croatian: Olanzapin je učinkovit u održavanju kliničkog poboljšanja tijekom nastavka kontinuirane terapije u bolesnika koji su pokazali početni odgovor na liječenje.
English: There were more smokers among subjects with cirrhosis (4/6; 67 %) than among subjects with no hepatic dysfunction (0/3; 0 %).
Croatian: Bilo je više pušača među ispitanicima s cirozom (4/6, 67%) nego među ispitanicima koji nisu imali disfunkciju jetre (0/3, 0%).
English: The plasma protein binding of olanzapine was about 93 % over the concentration range of about 7 to about 1000 ng/ml.
Croatian: Vezanje olanzapina na proteine u plazmi bilo je oko 93 % preko raspona koncentracije od oko 7 do oko 1000 ng/ml.
English: The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Croatian: Sljedeća tablica prikazuje nuspojave i laboratorijske nalaze uočene iz spontanih izvješća i u kliničkim ispitivanjima.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I PRIMJENU
English: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Soya lecithin (E322) Xanthan gum (E415)
Croatian: Ovojnica tablete polivinilni alkohol titanijev dioksid (E171) talk (E553b) sojin lecitin (E322) ksantansku gumu (E415)
English: This leaflet was last revised in {month YYYY}.
Croatian: Ova uputa o lijeku je zadnji put revidirana u {mjesec GGGG}.
English: Ventricular tachycardia/fibrillation , sudden death (see section 4.4)11
Croatian: ventrikularna tahikardija/ fibrilacija, iznenadna smrt (vidjeti dio 4.4)11
English: NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Croatian: NMS je potencijalno po život opasno stanje povezano s primjenom antipsihotika.
English: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Croatian: Psi su podnosili pojedinačne oralne doze do 100 mg/kg bez smrtnog ishoda.