FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Croatian: Vrlo rijetko (utvrđeno kod manje od 1 na 10 000 bolesnika) uočena je pojava teškog stanja koje se naziva intususcepcija (kada se jedan dio crijeva uvuče unutar drugog dijela što dovodi do začepljenja crijeva) nakon primjene cjepiva protiv rotavirusa.
English: Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus.
Croatian: Rotarix se pokazao djelotvornijim od placeba u sprečavanju teškog gastroenteritisa uzrokovanog rotavirusom.
English: • a powder and solvent that are made up into an oral suspension in an oral applicator;
Croatian: • kao prašak i otapalo od kojih se priprema oralna suspenzija u oralnom aplikatoru;
English: This helps to protect against gastroenteritis caused by rotavirus.
Croatian: To pomaže u sprečavanju gastroenteritisa uzrokovanog rotavirusom.
English: The CHMP decided that Rotarix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Rotarix nadmašuju s njim povezane rizike te je za njega preporučio izdavanje odobrenja za stavljanje u promet.
English: The benefit of the vaccine was measured by looking at how many babies developed severe rotavirus gastroenteritis in the months after they had been vaccinated and before they had reached one year of age.
Croatian: Koristi cjepiva mjerene su s obzirom na broj dojenčadi u koje se razvio teški gastroenteritis uzrokovan rotavirusom u mjesecima nakon njihova cijepljenja i prije nego što su djeca navršila jednu godinu.
English: The main study compared Rotarix with placebo (a dummy vaccine) in over 63,000 babies who were born at full term (after a pregnancy of at least 36 weeks).
Croatian: U glavnom provedenom ispitivanju djelovanje lijeka Rotarix uspoređeno je s djelovanjem placeba (prividnog cjepiva) na više od 63 000 pravodobno rođene dojenčadi (nakon trudnoće u trajanju od najmanje 36 tjedana).
English: What is the risk associated with Rotarix?
Croatian: Koji su rizici povezani s lijekom Rotarix?
English: Why has Rotarix been approved?
Croatian: Zašto je Rotarix odobren?
English: What is Rotarix?
Croatian: Što je Rotarix?
English: When an infant is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘foreign' and makes defences against it. After vaccination, the immune system is able to respond more quickly when it is exposed to the virus again.
Croatian: Nakon što se dojenče cijepi, imunosni sustav (sustav koji se bori protiv bolesti) prepoznaje oslabljeni virus kao „strano tijelo” i stvara obrambeni mehanizam protiv njega.
English: The study in premature babies showed that Rotarix was well tolerated and produced similar levels of antibodies as in infants born at full term.
Croatian: Ispitivanje provedeno na prijevremeno rođenoj djeci pokazalo je da se lijek Rotarix dobro podnosi te da proizvodi slične količine antitijela kao i u pravodobno rođene djece.
English: These results were compared with the findings of a study in babies born at full term who were vaccinated with Rotarix.
Croatian: Dobiveni rezultati uspoređeni su s rezultatima ispitivanja provedenog na pravodobno rođenoj djeci cijepljenoj lijekom Rotarix.
English: • an oral suspension in a prefilled oral applicator;
Croatian: • kao oralna suspenzija u napunjenom oralnom aplikatoru;
English: Rotarix is a vaccine that is given by mouth.
Croatian: Rotarix je cjepivo koje se primjenjuje oralno.
English: What is Rotarix used for?
Croatian: Za što se Rotarix koristi?
English: What benefit has Rotarix shown during the studies?
Croatian: Koje su koristi lijeka Rotarix utvrđene u ispitivanjima?
English: How does Rotarix work?
Croatian: Kako Rotarix djeluje?
English: For the full list of all side effects reported with Rotarix, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Rotarix potražite u uputi o lijeku.
English: How is Rotarix used?
Croatian: Kako se Rotarix koristi?
English: A further study looked at the safety of Rotarix and its ability to stimulate the production of antibodies in 1,009 babies born up to 13 weeks prematurely.
Croatian: U dodatnom ispitivanju provedenom na 1 009 dojenčadi rođenoj do 13 tjedana prijevremeno, ispitivana je sigurnost lijeka Rotarix i njegova sposobnost poticanja proizvodnje antitijela.
English: How has Rotarix been studied?
Croatian: Kako je Rotarix ispitivan?
English: Vaccination with Rotarix should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Croatian: U djece kod koje dođe do iznenadne vrućice, proljeva ili povraćanja cijepljenje lijekom Rotarix treba odgoditi.
English: Contains aspartame.
Croatian: Sadrži aspartam.
English: - Tell your 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 ranije imali krvne ugruške, jer su lijekovi poput ovih povezani sa stvaranjem krvnih ugrušaka.
English: If you are pregnant or breast-feeding, think you might 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 imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: If you notice any of these symptoms seek medical advice immediately;
Croatian: Ako primijetite bilo koji od ovih simptoma, odmah zatražite liječnički savjet;
English: Date of latest renewal: 19 August 2014
Croatian: Datum posljednje obnove: 19 Kolovoz 2014
English: Gröbenzell, Germany
Croatian: Gröbenzell, Njemačka
English: City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Croatian: City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Češka Republika
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 tegobe s očima kao što su određene vrste glaukoma (povišeni očni tlak).
English: Your doctor will tell you how many Olanzapine Glenmark tablets to take and how long you should continue to take them.
Croatian: Liječnik će Vam reći koliko Olanzapine Glenmark tableta trebate uzeti i koliko ćete ih dugo nastaviti uzimati.
English: Hertfordshire, WD18 8YA, United Kingdom
Croatian: Hertfordshire, WD18 8YA, Velika Britanija
English: 28 tablets 35 tablets 56 tablets 70 tablets 98 tablets
Croatian: 28 tableta 35 tableta 56 tableta 70 tableta 98 tableta
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: 16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients.
Croatian: 16 Povišene razine prolaktina u plazmi prijavljene su u 47,4% adolescentnih bolesnika.
English: Date of first authorisation: 03 December 2009 Date of latest renewal: 19 August 2014
Croatian: Datum prvog odobrenja: 03 Prosinac 2009 Datum posljednje obnove: 19 Kolovoz 2014
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: Store below 30C.
Croatian: Čuvati na temperaturi ispod 30°C.
English: Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Croatian: Olanzapin se metabolizira u jetri konjugacijskim i oksidacijskim putevima.
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 do 1 na 10 osoba) uglavnom na licu ili jeziku;
English: Keep this medicine out of sight and reach of children
Croatian: Ovaj lijek čuvajte izvan pogleda i dohvata djece.
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 bolesnica (n=467) pokazao profil sigurnosti usporediv s onim u bolesnika (n=869).
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 poluvijek olanzapina malena je u usporedbi s ukupnom varijabilnošću 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 ni klastogen u punom rasponu standardnih testova koji su uključivali testove bakterijske mutacije te in vitro i in vivo testove na sisavcima.
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Croatian: Vrlo često: sedacija (uključujući: hipersomniju, letargiju, somnolenciju).
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 kancerogen.
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: 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 iznad 65 godina doziranje od 5 do 20 mg/dan nije bilo povezano ni sa kakvim posebnim profilom nuspojava.
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) ni trajanjem liječenja.
English: In patients with Parkinson's disease Olanzapine Glenmark may worsen the symptoms.
Croatian: U bolesnika koji boluju od Parkinsonove bolesti, Olanzapine Glenmark može pogoršati simptome.
English: Olanzapine is bound predominantly to albumin and α1-acid-glycoprotein.
Croatian: Olanzapin se prvenstveno veže za albumin i α1-kiseli-glikoprotein.
English: 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI)
Croatian: 1 Klinički značajno povećanje tjelesne težine uočeno je u svim početnim kategorijama indeksa tjelesne mase (BMI).
English: Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite.
Croatian: Vrlo često: povećanje tjelesne težine13, povišene razine triglicerida14, povećan apetit.
English: Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Croatian: Prijavljeni su smrtni ishodi kod akutnog predoziranja već pri maloj dozi od 450 mg, ali je opisano i preživljavanje nakon akutnog predoziranja s približno 2 g oralnog olanzapina.
English: Children and adolescents Olanzapine Glenmark is not for patients who are under 18 years.
Croatian: Djeca i adolescenti Olanzapine Glenmark nije za primjenu u bolesnika mlađih od 18 godina.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: What Olanzapine Glenmark is and what it is used for
Croatian: Što je Olanzapin Glenmark i za što se koristi
English: If you forget to take Olanzapine Glenmark Take your tablets as soon as you remember.
Croatian: Ako ste zaboravili uzeti lijek Olanzapine Glenmark Uzmite tablete čim se sjetite.
English: Clinically significant weight gain (≥ 7 %) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Croatian: Čini se da se klinički značajno povećanje tjelesne težine (≥ 7%) češće javlja u populaciji adolescenata u usporedbi s odraslim osobama s usporedivim izlaganjima lijeku.
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Croatian: Niža početna doza (5 mg/dan) nije rutinski indicirana, no treba je razmotriti u osoba u dobi od 65 ili više godina, kada to opravdavaju klinički čimbenici (vidjeti dio 4.4).
English: Patients should be advised not to breast- feed an infant if they are taking olanzapine.
Croatian: Bolesnice treba savjetovati da ne doje dijete ako uzimaju olanzapin.
English: What Olanzapine Glenmark is and what it is used for What you need to know before you take Olanzapine Glenmark How to take Olanzapine Glenmark Possible side effects
Croatian: Što je Olanzapin Glenmark i za što se koristi Što morate znati prije nego počnete uzimati Olanzapin Glenmark Kako uzimati Olanzapin Glenmark Moguće nuspojave
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blisters
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Aluminijski blisteri
English: You should take your Olanzapine Glenmark tablets once a day following the advice of your doctor.
Croatian: Olanzapine Glenmark tablete morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.
English: A mass balance study showed that approximately 57 % of radiolabelled olanzapine appeared in urine, principally as metabolites.
Croatian: Ispitivanje masene bilance pokazalo je da se približno 57% olanzapina označenog radioizotopom pojavljuje u mokraći, uglavnom u obliku metabolita.
English: You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Glenmark can pass into breast milk.
Croatian: Ne biste smjeli uzimati ovaj lijek dok dojite, jer se male količine lijeka Olanzapine Glenmark mogu izlučiti u majčino mlijeko.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Croatian: Ne koristite epinefrin, dopamin ili druge simpatomimetike s beta-agonističkim djelovanjem jer beta stimulacija može pogoršati hipotenziju.
English: How to store Olanzapine Glenmark Contents of the pack and other information
Croatian: Kako čuvati Olanzapin Glenmark Sadržaj pakiranja i druge informacije
English: • Carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepresant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Glenmark dose.
Croatian: • karbamazepin (antiepileptik i stabilizator raspoloženja), fluvoksamin (antidepresiv) ili ciprofloksacin (antibiotik) - možda će biti potrebno promijeniti dozu lijeka Olanzapine
English: If you take more Olanzapine Glenmark than you should Patients who have taken more Olanzapine Glenmark than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Croatian: Ako uzmete više lijeka Olanzapine Glenmark nego što ste trebali Bolesnici koji su uzeli više lijeka Olanzapine Glenmark nego što su trebali imaju sljedeće simptome: ubrzan rad srca, uznemirenost/agresivnost, poteškoće s govorom, neuobičajene pokrete (osobito lica ili jezika) i sniženu razinu svijesti.
English: The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Croatian: Povećanje tjelesne težine i udio adolescentnih bolesnika koji su imali klinički značajno povećanje tjelesne težine bili su veći tijekom dugotrajnog izlaganja (najmanje 24 tjedana) nego tijekom kratkotrajnog izlaganja lijeku.
English: • blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Croatian: • krvne ugruške u venama (manje česta nuspojava koja se može pojaviti u do 1 na 100 osoba), posebno u nogama (simptomi uključuju oticanje, bol i crvenilo nogu), koji mogu putovati krvnim žilama do pluća, uzrokujući bol u prsima i otežano disanje.
English: Common: Elevated cholesterol levels 15
Croatian: Često: povišene razine kolesterola15
English: However the risk of tardive dyskinesia increases with long-term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
Croatian: Međutim, rizik od tardivne diskinezije povećava se s dugotrajnom izloženošću te u slučaju pojave znakova ili simptoma tardivne diskinezije u bolesnika na olanzapinu treba razmotriti snižavanje doze ili prekid liječenja.
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Croatian: Srednja vrijednost izloženosti novorođenčeta (mg/kg) u stanju dinamičke ravnoteže procijenjena je na 1,8% majčine doze olanzapina (mg/kg).
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16
Croatian: Vrlo često: smanjenje ukupnog bilirubina, povećan GGT, povišene razine prolaktina u plazmi16.
English: • If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
Croatian: • ako znate da možda imate nedovoljno soli u organizmu kao posljedicu dugotrajnog teškog proljeva i povraćanja ili zbog uzimanja diuretika (tableta za izlučivanje vode iz organizma)
English: Olanzapine Glenmark 2.5 mg tablets Olanzapine Glenmark 5 mg tablets Olanzapine Glenmark 7.5 mg tablets Olanzapine Glenmark 10 mg tablets Olanzapine Glenmark 15 mg tablets Olanzapine Glenmark 20 mg tablets
Croatian: Olanzapin Glenmark 2,5 mg tablete Olanzapin Glenmark 5 mg tablete Olanzapin Glenmark 7,5 mg tablete Olanzapin Glenmark 10 mg tablete Olanzapin Glenmark 15 mg tablete Olanzapin Glenmark 20 mg tablete olanzapin
English: Ventricular tachycardia/fibrillation, sudden death (see section 4.4)11
Croatian: ventrikularna tahikardija/ fibrilacija, iznenadna smrt (vidjeti dio 4.4)11
English: It is important that you carry on taking Olanzapine Glenmark for as long as your doctor tells you.
Croatian: Važno je da nastavite uzimati lijek Olanzapine Glenmark onoliko dugo koliko Vam je liječnik rekao.
English: However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Croatian: Međutim, incidencija smrtnosti bila je veća u bolesnika liječenih olanzapinom nego u bolesnika koji su primali placebo, neovisno o ovim čimbenicima rizika.
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Glenmark unless your doctor tells you to.
Croatian: Ako Vam se simptomi vrate, posavjetujte se sa svojim liječnikom, ali nemojte prestati uzimati lijek Olanzapine Glenmark dok Vam liječnik to ne kaže.
English: The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Glenmark in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Croatian: Sljedeći simptomi mogu se pojaviti u novorođenčadi majki koje su koristile lijek Olanzapine Glenmark u posljednjem tromjesečju (zadnja tri mjeseca trudnoće): drhtanje, ukočenost mišića i/ili slabost, pospanost, uznemirenost, tegobe s disanjem te poteškoće u hranjenju.
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Croatian: Podaci o djelotvornosti iz kontroliranih ispitivanja u adolescenata (u dobi od 13 do 17 godina) su ograničeni na kratkotrajna ispitivanja u shizofreniji (6 tjedana) i maniji povezanima s bipolarnim poremećajem I (3 tjedna), a obuhvatilo je manje od 200 adolescenata.
English: Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10 %) of tremor, dry mouth, increased appetite, and weight gain.
Croatian: Olanzapin primijenjen s litijem ili valproatom rezultirao je povećanim razinama ( 10%) tremora, suhoće usta, povećanjem apetita i povećanjem tjelesne težine.
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% u rasponu koncentracija od približno 7 do približno 1000 ng/ml.
English: In a retrospective observational cohort study, the risk of presumed sudden cardiac death in patients treated with olanzapine was approximately twice the risk in patients not using antipsychotics.
Croatian: U retrospektivnom opservacijskom kohortnom ispitivanju rizik od pretpostavljene iznenadne srčane smrti u bolesnika liječenih olanzapinom bio je otprilike dvostruko veći nego u bolesnika koji nisu uzimali antipsihotike.
English: • Medicines for Parkinson's disease
Croatian: • lijekove protiv Parkinsonove bolesti
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female non smokers and 77 % in male smokers.
Croatian: Srednja vrijednost porasta Cmax olanzapina nakon primjene fluvoksamina iznosio je 54% u žena nepušača i 77% u muškaraca pušača.
English: • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Croatian: U ranim fazama liječenja neki bolesnici mogu osjećati omaglicu ili nesvjesticu (uz usporen rad srca), posebno pri uspravljanju iz ležećeg ili sjedećeg položaja tijela.
English: In the same clinical trials, cerebrovascular adverse events (CVAE e.g., stroke, transient ischemic attack), including fatalities, were reported.
Croatian: U istim kliničkim ispitivanjima prijavljeni su cerebrovaskularni štetni događaji (CV štetni događaji, primjerice moždani udar, prolazni ishemijski napad), uključujući smrtne slučajeve.
English: Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Croatian: S obzirom na primarne učinke olanzapina na središnji živčani sustav, oprez je potreban kod njegove primjene u kombinaciji s drugim centralno djelujućim lijekovima i alkoholom.
English: The daily dose of Olanzapine Glenmark is between 5 mg and 20 mg.
Croatian: Dnevna doza lijeka Olanzapine Glenmark iznosi između 5 mg i 20 mg.
English: Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/day.
Croatian: Olanzapin se primjenjivao u fleksibilnoj dozi koja je započinjala s 2,5 mg dnevno i postupno je povećavana do 20 mg dnevno.