FrancophonIA/ELRC3.0 huggingface dataset:
English: The reconstituted product must be filtered by using the vial adapter before injection to remove any possible particles in the solution.
Croatian: Pripremljeni se lijek prije injekcije mora filtrirati pomoću nastavka za bočicu kako bi se iz otopine uklonile moguće čestice.
English: Prophylactic treatment in subjects ≥12 years
Croatian: Profilaktičko liječenje u ispitanika u dobi
English: Jivi Patients ≥12 years n=22
Croatian: ≥12 godina N=22
English: No cross-reactivity of anti-PEG IgM antibodies with other unmodified factor VIII products was observed.
Croatian: Nije bila opažena ukrižena reaktivnost IgM protutijela na PEG s drugim lijekovima koji sadrže nemodificirani FVIII.
English: Inject the solvent by slowly pushing down on the plunger rod (G).
Croatian: Ubrizgajte otopinu postiskujući polagano potisnik klipa prema dolje (G).
English: PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection.
Croatian: OBLIK I SADRŽAJ prašak i otapalo za otopinu za injekciju
English: The total number of exposure days (ED) was 18432 with a median of 131 ED (range: 1 to 309) per subject; median time in study for paediatric patients < 12 years was 237 days with a total of 3219 ED and median of 53 ED (range 1-68) per subject.
Croatian: Ukupan broj dana izloženosti (engl. exposure days, ED) bio je 18 432 s medijanom od 131 ED (raspon: 1 - 309) po ispitaniku; medijan vremena u ispitivanju za pedijatrijske bolesnike u dobi
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Jivi.
Croatian: Detaljne upute za pripremu i primjenu lijeka navedene su u uputi o lijeku, priloženoj uz lijek Jivi.
English: Detailed instructions for reconstitution and administration of Jivi You will need alcohol swabs, gauze pads, plasters and tourniquet.
Croatian: Bit će Vam potrebni jastučići natopljeni alkoholom, jastučići gaze, flasteri i poveska.
English: For reconstitution using the vial adapter read package leaflet before use.
Croatian: Za rekonstituciju koristite nastavak za bočicu i pročitajte uputu o lijeku prije uporabe.
English: Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection
Croatian: Jivi 250 IU prašak i otapalo za otopinu za injekciju Jivi 500 IU prašak i otapalo za otopinu za injekciju Jivi 1000 IU prašak i otapalo za otopinu za injekciju Jivi 2000 IU prašak i otapalo za otopinu za injekciju Jivi 3000 IU prašak i otapalo za otopinu za injekciju
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA S 30 POJEDINAČNIH PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Grasp the plunger rod as per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C).
Croatian: Uhvatite potisnik klipa kao na slici i pričvrstite potisnik čvrstim uvrtanjem u čep s navojem, vrteći u smjeru kazaljke na satu (C).
English: Median time on study for the 148 patients ≥12 years of age was 713 days.
Croatian: Medijan vremena u ispitivanju za 148 bolesnika u dobi
English: • rash, skin reddening
Croatian: • osip, crvenilo kože
English: For Jivi some silica-based one-stage assays (e.g., APTT-SP, STA-PTT) may underestimate the factor VIII activity of Jivi in plasma samples; some reagents, e.g. with kaolin-based activators, have the potential for overestimation.
Croatian: . Kod primjene lijeka Jivi neki jednostupanjski testovi temeljeni na silicijevu dioksidu (npr. APTT-SP, STA-PTT) mogu procijeniti aktivnost faktora VIII u lijeku Jivi u uzorcima plazme kao nižu u odnosu na stvarnu vrijednost, dok je neki reagensi, npr. aktivatori koji se temelje na kaolinu, mogu procijeniti kao višu.
English: Within its overall shelf life of 2 years, the product (when kept in its outer carton) may be stored at up to 25 °C for a limited period of 6 months.
Croatian: Unutar ukupnog roka valjanosti od 2 godine lijek se može čuvati na temperaturi do 25 °C u ograničenom razdoblju od 6 mjeseci (kad se čuva u vanjskom pakiranju).
English: Place the powder vial on a firm, non-slip surface.
Croatian: Postavite bočicu s praškom na čvrstu podlogu koja nije skliska.
English: INFORMATION IN BRAILLE Jivi 2000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Jivi 2000
English: Allergic type hypersensitivity reactions are possible with Jivi.
Croatian: Na lijek Jivi moguće su reakcije preosjetljivosti alergijskog tipa.
English: The following side effects may occur with this medicine:
Croatian: Uz ovaj lijek mogu se javiti sljedeće nuspojave:
English: After reconstitution the solution is clear.
Croatian: Nakon pripreme za primjenu, dobivena otopina je bistra.
English: Paediatric population < 12 years of age
Croatian: Pedijatrijska populacija u dobi
English: • Do not refrigerate after reconstitution.
Croatian: • Nakon rekonstitucije ne odlagati u hladnjak.
English: In completed clinical studies with 73 paediatric PTPs < 12 years (44 PTPs < 6 years, 29 PTPs 6¬<12 years), adverse reactions due to immune response to PEG were observed in children less than
Croatian: < 12 godina (44 prethodno liječena bolesnika u dobi < 6 godina, 29 prethodno liječenih bolesnika u dobi od 6 do < 12 godina), nuspojave zbog imunološkog odgovora na PEG bile su zabilježene u djece mlađe od 6 godina.
English: • a blood clot in the blood vessel
Croatian: • krvni ugrušak u krvnoj žili.
English: AUCnorm (kg.h/dL) t1/2 (h) Vss (dL/kg) CL (dL/h/kg)
Croatian: t1/2 (h) Vss (dl/kg) CL (dl/h/kg)
English: INFORMATION IN BRAILLE Jivi 250
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Jivi 250
English: • one pre-filled syringe with 2.5 mL solvent (clear type 1 glass cylinder syringe with grey bromobutyl rubber blend stopper)
Croatian: • jednu napunjenu štrcaljku s 2,5 ml otapala (tijelo štrcaljke od prozirnog stakla tipa
English: • dizziness
Croatian: • svrbež.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA POJEDINAČNOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: If you use more Jivi than you should Tell your doctor if this occurs.
Croatian: Ako primijenite više lijeka Jivi nego što ste trebali
English: 6 years of age.
Croatian: ≥ 12 godina.
English: How to use Jivi
Croatian: Kako primjenjivati Jivi
English: A total of 232 previously treated patients with severe haemophilia A have been exposed in the clinical trial program which included one phase I study and two phase II/III studies.
Croatian: U programu kliničkih ispitivanja koji se sastojao od jednog ispitivanja faze I i dva ispitivanja faze II/III ukupno su bila izložena 232 prethodno liječena bolesnika s teškom hemofilijom A.
English: PK parameter(unit) 12-<18 years N=12
Croatian: 12 - < 18 godina N=12
English: 6.3 Shelf¬life
Croatian: 6.3 Rok valjanosti
English: Jivi is provided as a powder and solvent for solution for injection.
Croatian: Jivi se sastoji od praška i otapala za otopinu za injekciju.
English: Jivi is not indicated in patients < 12 years of age and in previously untreated patients.
Croatian: < 12 godina niti u prethodno neliječenih bolesnika.
English: Solvent: clear solution.
Croatian: Otapalo: bistra otopina.
English: INFORMATION IN BRAILLE Jivi 1000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Jivi 1000
English: EXP (End of the 6 month period, if stored up to 25 °C): ................ Do not use after this date.
Croatian: Rok valjanosti (kraj razdoblja od 6 mjeseci ako se lijek čuva na temperaturi do 25 °C): ................
English: • a pre-filled syringe of solvent
Croatian: • napunjenu štrcaljku s otapalom
English: Treatment with Jivi will be started by a doctor who is experienced in the care of patients with haemophilia A. After suitable training patients or carers may be able to give Jivi at home.
Croatian: Nakon odgovarajućeg uvježbavanja, bolesnici ili njegovatelji mogu davati Jivi kod kuće.
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration
Croatian: Lijekove za parenteralnu primjenu prije primjene treba vizualno pregledati kako bi se isključila prisutnost čestica i promjena boje.
English: INFORMATION IN BRAILLE Jivi 500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Jivi 500
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj često
English: INFORMATION IN BRAILLE Jivi 3000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Jivi 3000
English: Stop injecting Jivi immediately and speak to your doctor at once if such reactions occur.
Croatian: Ako nastupi takva reakcija, odmah prekinite ubrizgavanje lijeka Jivi i što prije se javite liječniku.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified Bethesda assay.
Croatian: Ti su inhibitori obično IgG imunoglobulini koji djeluju protiv prokoagulacijske aktivnosti faktora VIII, a njihova se količina određuje u Bethesda jedinicama (engl.
English: Attach the pre-filled syringe to the threaded vial adapter by turning clockwise (F).
Croatian: Pričvrstite napunjenu štrcaljku na nastavak za bočicu s navojem okrećući je u smjeru kazaljke na satu (F).
English: Jivi 2000 IU contains 800 IU damoctocog alfa pegol per mL after reconstitution (2000 IU / 2.5 mL).
Croatian: Jivi 2000 IU sadrži 800 IU damoktokog alfa pegola po ml nakon rekonstitucije (2000 IU/2,5 ml).
English: • nettle¬rash, flushing
Croatian: • koprivnjača, navale crvenila
English: Jivi 250 IU contains 100 IU damoctocog alfa pegol per mL after reconstitution (250 IU / 2.5 mL).
Croatian: Jivi 250 IU sadrži 100 IU damoktokog alfa pegola po ml nakon rekonstitucije (250 IU/2,5 ml).
English: • one vial with powder (10 mL clear type 1 glass vial with grey bromobutyl rubber blend stopper and aluminium seal)
Croatian: • jednu bočicu s praškom (bočica od 10 ml od prozirnog stakla tipa
English: The active substance is PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol).
Croatian: Djelatna tvar je pegilirani rekombinantni ljudski koagulacijski faktor VIII s uklonjenom B-domenom (damoktokog alfa pegol).
English: Life-threatening Haemorrhages
Croatian: Po život opasna krvarenja
English: Jivi 3000 IU contains 1200 IU damoctocog alfa pegol per mL after reconstitution (3000 IU / 2.5 mL).
Croatian: Jivi 3000 IU sadrži 1200 IU damoktokog alfa pegola po ml nakon rekonstitucije (3000 IU/2,5 ml).
English: • bleeding that is not being controlled with your usual dose of this medicine.
Croatian: • imate krvarenje koje se ne zaustavlja uobičajenom dozom lijeka . Ako se to dogodi, odmah se obratite svom liječniku.
English: Jivi 500 IU contains 200 IU damoctocog alfa pegol per mL after reconstitution (500 IU / 2.5 mL).
Croatian: Jivi 500 IU sadrži 200 IU damoktokog alfa pegola po ml nakon rekonstitucije (500 IU/2,5 ml).
English: Jivi 1000 IU contains 400 IU damoctocog alfa pegol per mL after reconstitution (1000 IU / 2.5 mL).
Croatian: Jivi 1000 IU sadrži 400 IU damoktokog alfa pegola po ml nakon rekonstitucije (1000 IU/2,5 ml).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU (damoctocog alfa pegol) .
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 250 IU (damoktokog alfa pegol).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Jivi 250 IU contains 100 IU damoctocog alfa pegol per mL after reconstitution (250 IU / 2.5 mL).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jivi 250 IU sadrži 100 IU damoktokog alfa pegola po ml nakon rekonstitucije (250 IU/2,5 ml).
English: How Jivi is given
Croatian: Kako se daje lijek Jivi
English: Jivi 250 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 100 IU (250 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Croatian: Jivi 250 IU prašak i otapalo za otopinu za injekciju Nakon rekonstitucije priloženim otapalom, jedan ml otopine sadrži približno 100 IU (250 IU/2,5 ml) ljudskog koagulacijskog faktora VIII, damoktokog alfa pegola.
English: Jivi 2000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 800 IU (2000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Croatian: Jivi 2000 IU prašak i otapalo za otopinu za injekciju Nakon rekonstitucije priloženim otapalom, jedan ml otopine sadrži približno 800 IU (2000 IU/2,5 ml) ljudskog koagulacijskog faktora VIII, damoktokog alfa pegola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/006 - 30 x (Jivi 250 IU)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1324/006- 30 x (Jivi 250 IU)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/007 - 30 x (Jivi 500 IU)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1324/007 - 30 x (Jivi 500 IU)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
English: Jivi 3000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 1200 IU (3000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Croatian: Jivi 3000 IU prašak i otapalo za otopinu za injekciju Nakon rekonstitucije priloženim otapalom, jedan ml otopine sadrži približno 1200 IU (3000 IU/2,5 ml) ljudskog koagulacijskog faktora VIII, damoktokog alfa pegola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/009 - 30 x (Jivi 2000 IU)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1324/009 - 30 x (Jivi 2000 IU)
English: Jivi 500 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 200 IU (500 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Croatian: Jivi 500 IU prašak i otapalo za otopinu za injekciju Nakon rekonstitucije priloženim otapalom, jedan ml otopine sadrži približno 200 IU (500 IU/2,5 ml) ljudskog koagulacijskog faktora VIII, damoktokog alfa pegola.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (damoctocog alfa pegol).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 3000 IU (damoktokog alfa pegol).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (damoctocog alfa pegol).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 IU (damoktokog alfa pegol).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Nervous system disorders
Croatian: • zasebni potisnik klipa
English: Hold the pre-filled syringe of solvent upright.
Croatian: Ubodite venu te pričvrstite pribor za venepunkciju flasterom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (damoctocog alfa pegol).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2000 IU (damoktokog alfa pegol).
English: Jivi 1000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 400 IU (1000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Croatian: Jivi 1000 IU prašak i otapalo za otopinu za injekciju Nakon rekonstitucije priloženim otapalom, jedan ml otopine sadrži približno 400 IU (1000 IU/2,5 ml) ljudskog koagulacijskog faktora VIII, damoktokog alfa pegola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/008 - 30 x (Jivi 1000 IU)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1324/008 - 30 x (Jivi 1000 IU)
English: Jivi 250 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Croatian: Jivi 250 IU prašak i otapalo za otopinu za injekciju pegilirani rekombinantni ljudski koagulacijski faktor VIII s uklonjenom B-domenom (damoktokog alfa pegol)
English: Jivi 500 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Croatian: Jivi 500 IU prašak i otapalo za otopinu za injekciju pegilirani rekombinantni ljudski koagulacijski faktor VIII s uklonjenom B-domenom (damoktokog alfa pegol)
English: Jivi 2000 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Croatian: Jivi 2000 IU prašak i otapalo za otopinu za injekciju pegilirani rekombinantni ljudski koagulacijski faktor VIII s uklonjenom B-domenom (damoktokog alfa pegol)
English: Jivi 3000 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Croatian: Jivi 3000 IU prašak i otapalo za otopinu za injekciju pegilirani rekombinantni ljudski koagulacijski faktor VIII s uklonjenom B-domenom (damoktokog alfa pegol)
English: • a separate plunger rod
Croatian: • navale crvenila
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU (damoctocog alfa pegol).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 IU (damoktokog alfa pegol).
English: • a venipuncture set
Croatian: • pribor za venepunkciju
English: Jivi 1000 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Croatian: Jivi 1000 IU prašak i otapalo za otopinu za injekciju pegilirani rekombinantni ljudski koagulacijski faktor VIII s uklonjenom B-domenom (damoktokog alfa pegol)
English: • one syringe plunger rod
Croatian: • jedan potisnik klipa štrcaljke
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte ljekarnika kako bacaju lijekove koje više ne koristite.
English: Store below 30°C.
Croatian: Čuvati ispod 30 ° C.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne
English: Your doctor will tell you how many OLANZAPINE CIPLA tablets to take and how long you should continue to take them.
Croatian: Liječnik će Vam reći koliko OLANZAPINE CIPLA tableta trebate uzeti i koliko ćete ih dugo nastaviti uzimati.
English: Date of first authorisation: 14 November 2007 Date of latest renewal: 01 October 2012
Croatian: Datum posljednje obnove odobrenja: 1. listopad 2012
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
English: Do not throw away any medicines via wastewater or household waste.
Croatian: Nemojte bacati bilo kakve lijekove odvode niti u kućni otpad.
English: Store below 30ºC.
Croatian: Čuvati ispod 30 º C.
English: As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Croatian: Kao i s drugim antipsihoticima, preporučuje se povremeno mjerenje krvnog tlaka u bolesnika starijih od 65 godina.
English: Such factors possibly contribute to the higher average exposure observed in adolescents.
Croatian: Ti faktori moguće doprinose većoj prosječnoj izloženosti uočenoj u
English: Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Croatian: Dugoročni ishodi povezani s ovim događajima nisu proučavani i još su nepoznati (vidjeti dijelove 4.8 i 5.1).
English: Talk to your doctor or pharmacist before you take OLANZAPINE CIPLA.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek OLANZAPINE CIPLA.
English: Do not use this medicine after the expiry date which is stated on the carton after Exp. Store in the original package.
Croatian: Nemojte koristiti ovaj lijek nakon isteka roka valjanosti navedenog na pakovanju nakon Exp.
English: There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
Croatian: Ne postoje podaci o održavanju učinka i ograničeni su podaci o dugotrajnoj sigurnosti (vidjeti dijelove 4.4 i 4.8).
English: You should take your OLANZAPINE CIPLA tablets once a day following the advice of your doctor.
Croatian: OLANZAPINE CIPLA tablete morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.
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
English: Smokers 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: • iIf you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični (preosjetljivi) na olanzapin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: • Whenever the risk management system is modified,especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu
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 kraćima od 24 sata.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Croatian: Psihoza i/ili poremećaji ponašanja uzrokovani demencijom Olanzapin nije odobren za liječenje psihoze i/ili poremećaja ponašanja uzrokovanih demencijom te se njegova primjena ne preporučuje u ovoj specifičnoj skupini bolesnika zbog porasta mortaliteta i rizika od pojave cerebrovaskularnog događaja.
English: Pharmacotherapeutic group: diazepines, oxazepines and thiazepines., ATC code: N05A H03.
Croatian: Farmakoterapijska skupina: diazepini, oksazepini i tiazepini, ATK oznaka: N05AH03.
English: Ventricular tachycardia/fibrillation , sudden death (see section 4.4)11
Croatian: ventrikularna tahikardija/fibrilacija, iznenadna smrt (vidjeti dio 4.4)11
English: In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
Croatian: U slučajevima umjerene insuficijencije jetre (ciroza, Child-Pugh stadij A ili B), početna doza treba biti 5 mg i može se povećati samo uz