FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptomatic mouth and throat candidiasis can be treated with topical antifungal therapy whilst still continuing with Airexar Spiromax.
Croatian: Simptomatska kandidijaza usta i grla može se liječiti topikalnim antimikoticima dok se istodobno može nastaviti terapija Airexar Spiromaxom.
English: Airexar Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Croatian: Airexar Spiromax nije indiciran za primjenu u djece u dobi od 12 godina i mlađih ili adolescenata u dobi od 13 do 17 godina.
English: Symptomatic candidiasis of the mouth and throat can be treated with topical anti-fungal therapy whilst still continuing with Airexar Spiromax.
Croatian: Simptomatska kandidijaza usta i grla može se liječiti topikalnim antimikoticima dok se istodobno može nastaviti terapija Airexar
English: Airexar Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action.
Croatian: Mehanizam djelovanja i farmakodinamički učinci Airexar Spiromax sadrži salmeterol i flutikazonpropionat, koji imaju drugačije načine djelovanja.
English: Airexar Spiromax should only be used to treat severe asthma in adults aged 18 years and older and
Croatian: Airexar Spiromax smije se primjenjivati samo za liječenje teške astme u odraslih u dobi od 18 godina i starijih te odraslih s KOPB-om.
English: Airexar Spiromax is indicated in adults 18 years of age and older only.
Croatian: Airexar Spiromax je indiciran samo u odraslih u dobi od 18 godina i starijih.
English: Airexar Spiromax 50 micrograms/500 micrograms inhalation powder salmeterol/fluticasone propionate
Croatian: Airexar Spiromax 50 mikrograma/500 mikrograma prašak inhalata salmeterol/flutikazonpropionat
English: forceful inhalation) was over 60 L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Croatian: Srednja vrijednost postignutog PIFR-a u bolesnika s astmom ili KOPB-om koji su bili optimalno podučeni (tj. snažni udah) iznosila je više od 60 l/min, što je brzina protoka pri kojoj se zna da oba ispitivana inhalatora ispostavljaju usporedive količine lijeka u pluća.
English: 4.3 Contraindications
Croatian: 4.9 Predoziranje
English: Tell your doctor if you are taking the following medicines, before starting to use Airexar Spiromax:
Croatian: Obavijestite svog liječnika, prije nego što počnete primjenjivati Airexar Spiromax, ako uzimate sljedeće
English: - if you are allergic (hypersensitive) to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete primjenjivati Airexar Spiromax Nemojte primjenjivati Airexar Spiromax: - ako ste alergični (preosjetljivi) na salmeterol, flutikazonpropionata ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Airexar Spiromax should be used correctly in order to achieve effective treatment.
Croatian: Da bi se ostvarilo učinkovito liječenje, Airexar Spiromax treba ispravno koristiti.
English: When it is appropriate to titrate down to a lower strength not available for Airexar Spiromax, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is
Croatian: Kada je dozu primjereno titrirati na manju od one dostupne u ovom lijeku, Airexar Spiromax je potrebno zamijeniti drugom fiksnom kombinacijom salmeterola i flutikazonpropionata koja sadrži nižu dozu inhalacijskog kortikosteroida.
English: Airexar Spiromax 50 micrograms/500 micrograms inhalation powder
Croatian: Airexar Spiromax 50 mikrograma/500 mikrograma prašak inhalata
English: Cardiac arrhythmias (including supraventricular
Croatian: manje često rijetko nepoznato srčane aritmije (uključujući supraventrikularnu tahikardiju i ekstrasistole).
English: Airexar Spiromax is indicated for use in adults aged 18 years and older only.
Croatian: Airexar Spiromax je indiciran samo za primjenu u odraslih u dobi od 18 godina i starijih.
English: Airexar Spiromax is for the treatment of patients with severe asthma only.
Croatian: Airexar Spiromax namijenjen je samo za liječenje bolesnika s teškom astmom.
English: Airexar Spiromax is only appropriate for use in the treatment of patients with severe asthma.
Croatian: Airexar Spiromax je primjeren za primjenu samo u liječenju bolesnika s teškom astmom.
English: All patients should be provided with training by the prescribing Health Care Professional on how to use Airexar Spiromax.
Croatian: Liječnik koji bolesnicima propisuje Airexar Spiromax treba im omogućiti poduku o tome kako da ga koriste.
English: Some medicines may increase the effects of Airexar Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Croatian: Neki lijekovi mogu pojačati učinke lijeka Airexar Spiromax te će možda Vaš liječnik željeti pomno pratiti
English: Serious asthma-related adverse events and exacerbations may occur during treatment with Airexar Spiromax.
Croatian: Tijekom liječenja Airexar Spiromaxom mogu nastati ozbiljni štetni događaji povezani s astmom i egzacerbacije.
English: Not Known
Croatian: Potrebno je
English: What you need to know before you use Airexar Spiromax
Croatian: Što je Airexar Spiromax i za što se koristi Što morate znati prije nego počnete primjenjivati Airexar Spiromax Kako primjenjivati Airexar Spiromax
English: Airexar Spiromax is for use in patients with severe asthma only.
Croatian: Airexar Spiromax namijenjen je samo za primjenu u bolesnika s teškom astmom.
English: Potassium replacement should be considered.
Croatian: Pojava uz placebo nije se uzela u obzir.
English: Airexar Spiromax 50 micrograms/500 micrograms
Croatian: Airexar Spiromax 50 µg/500 µg
English: Airexar Spiromax affecting your adrenal glands.
Croatian: Airexar Spiromax sadrži laktozu
English: Lietuva
Croatian: Polska
English: - The active substances are salmeterol and fluticasone propionate.
Croatian: Što Airexar Spiromax sadrži - Djelatne tvari su salmeterol i flutikazonpropionat.
English: Tremor
Croatian: Poremećaji
English: Summary of safety profile
Croatian: • Periodička izvješća o neškodljivosti
English: Each 0.5 ml dose contains:
Croatian: Jedna doza od 0,5 ml sadrži:
English: *Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125 mg aluminium)
Croatian: *Konjugirano na nosač proteina CRM197 i adsorbirano na aluminijev fosfat (0,125 mg aluminija).
English: 1 multidose container (4 doses)
Croatian: 1 višedozni spremnik (4 doze)
English: pneumococcal conjugate serotype 6B* 4.4 µg pneumococcal conjugate serotype 9V* 2.2 µg pneumococcal conjugate serotype 18C* 2.2 µg
Croatian: konjugat pneumokoka serotipa 18C * 2,2 µg konjugat pneumokoka serotipa 19A * 2,2 µg konjugat pneumokoka serotipa 19F * 2,2 µg konjugat pneumokoka serotipa 23F * 2,2 µg
English: 1 pre-filled syringe with separate needle
Croatian: 1 napunjena štrcaljka s odvojenom iglom
English: 1 single dose vial
Croatian: 1 jednodozna bočica
English: • Sensitivity to sunlight.
Croatian: • osjetljivost na sunčevu svjetlost
English: • Prolonged and/or painful erection.
Croatian: • produženu i/ili bolnu erekciju
English: Drink it straightaway.
Croatian: Odmah popijte.
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: • problems with speech
Croatian: • poteškoće s govorom
English: It will dissolve directly in your mouth, so that it can be easily swallowed.
Croatian: Rastopit će se izravno u ustima te se može lako progutati.
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 svojeg liječnika što je prije moguće:
English: • Lowering of normal body temperature.
Croatian: • sniženje normalne tjelesne temperature
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 imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
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: • Memory loss or forgetfulness
Croatian: • gubitak pamćenja ili zaboravljivost
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: Keep this medicine out of sight and reach and of children
Croatian: Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: • muscle stiffness or spasms (including eye movements)
Croatian: • mišićnu ukočenost ili grč (uključujući pokrete očiju)
English: • seizures, usually associated with a history of seizures (epilepsy)
Croatian: • napadaje, obično povezane s napadajima u povijesti bolesti (epilepsija)
English: • Sudden unexplained death.
Croatian: • naglu neobjašnjivu smrt
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: • Unusual movements (dyskinesias).
Croatian: • neuobičajene pokrete (diskinezije)
English: • Changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Croatian: • promjene na grudima u muškaraca i žena, kao što je poremećaj stvaranja majčinog mlijeka ili abnormalan rast.
English: As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Croatian: Ako ste stariji od 65 godina liječnik će Vam možda kao rutinsku mjeru opreza redovito kontrolirati krvni tlak.
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 web stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: • Moderate to severe manic episodes,a condition with symptoms of excitement or euphoria
Croatian: • umjerenih do teških epizoda manije, stanja sa simptomima uzbuđenja ili euforije.
English: Your doctor will tell you how many Olanzapine Glenmark Europe orodispersible tablets to take and how long you should continue to take them.
Croatian: Liječnik će Vam reći koliko Olanzapin Glenmark Europe raspadljivih tableta za usta trebate uzeti i koliko ćete ih dugo uzimati.
English: Children and adolescents Olanzapine Glenmark Europe is not for patients who are under 18 years.
Croatian: Djeca i adolescenti Olanzapin Glenmark Europe nije za primjenu u bolesnika mlađih od 18 godina.
English: In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Croatian: U odraslih bolesnika koji su nakon 9-12 mjeseci završili liječenje, brzina povećanja srednje vrijednosti glukoze u krvi smanjila se nakon približno 6 mjeseci.
English: In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Glenmark tablets should be used.
Croatian: Kada je potrebno povećavati dozu u koracima od 2,5 mg, treba primjenjivati Olanzapin Glenmark tablete.
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: 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: Dystonia (including oculogyration) 11
Croatian: distonija (uključujući okulogiraciju)11
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 iznosila je 4,4 mg) ni trajanjem liječenja.
English: • Water retention leading to swelling of the hands, ankles or feet.
Croatian: • zadržavanje vode u tijelu koje dovodi do oticanja ruku, zglobova ili stopala
English: 6.4 Special precautions for storage Store below 30C.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati na temperaturi ispod 30°C.
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 manje od 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: If you take more Olanzapine Glenmark Europe than you should Patients who have taken more Olanzapine Glenmark Europe 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 Olanzapin Glenmark Europe tableta nego što ste trebali Bolesnici koji su uzeli više lijeka Olanzapin Glenmark Europe nego što su trebali imaju sljedeće simptome: ubrzani rad srca, uznemirenost/agresivnost, poteškoće s govorom, neuobičajene pokrete (osobito lica ili jezika) i sniženu razinu svijesti.
English: There is no specific antidote for olanzapine.
Croatian: Liječenje Nema specifičnog antidota za olanzapin.
English: • Carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepresant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Glenmark Europe dose.
Croatian: • karbamazepin (antiepileptik i stabilizator raspoloženja), fluvoksamin (antidepresiv) ili ciprofloksacin (antibiotik) - možda će biti potrebno promijeniti dozu lijeka Olanzapin Glenmark
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Croatian: U ispitivanjima u trajanju do 3 mjeseca na miševima te do godine dana na štakorima i psima, prevladavajući učinci bili su depresija središnjeg živčanog sustava, antikolinergički učinci i periferni hematološki poremećaji.
English: In patients with Parkinson's disease Olanzapine Glenmark Europe may worsen the symptoms
Croatian: U bolesnika koji boluju od Parkinsonove bolesti, Olanzapin Glenmark Europe može pogoršati simptome.
English: • Absence or decrease in menstrual periods.
Croatian: • izostanak ili smanjenje mjesečnice
English: The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Glenmark Europe 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 Olanzapin Glenmark Europe u posljednjem tromjesečju (zadnja tri mjeseca trudnoće): drhtanje, ukočenost mišića i/ili slabost, pospanost, uznemirenost, tegobe s disanjem te poteškoće u hranjenju.
English: Olanzapine Glenmark Europe belongs to a group of medicines called antipsychotics.
Croatian: Olanzapin Glenmark Europe pripada skupini lijekova koji se zovu antipsihotici.
English: The most frequently (seen in ≥ 1 % of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Croatian: Najčešće prijavljene nuspojave (uočene u ≥1% bolesnika) povezane s primjenom olanzapina u kliničkim ispitivanjima bile su somnolencija, povećanje tjelesne težine, eozinofilija, povišene vrijednosti prolaktina, kolesterola, glukoze i triglicerida (vidjeti dio 4.4), glikozurija, povećan apetit, omaglica, akatizija, parkinsonizam, leukopenija, neutropenija (vidjeti dio 4.4), diskinezija, ortostatska hipotenzija, antikolinergički učinci, prolazni asimptomatski porast vrijednosti jetrenih aminotransferaza (vidjeti dio 4.4), osip, astenija, umor, pireksija, artralgija, povišena razina alkalne fosfataze, visoka razina gama glutamiltransferaze, visoka razina mokraćne kiseline, visoka razina kreatin fosfokinaze i edem.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o učincima na sposobnost upravljanja vozilima i rada na strojevima.
English: • Liver disease appearing as yellowing of the skin and white parts of the eyes.
Croatian: • bolest jetre koja se očituje žutilom kože i bjeloočnica
English: Increased appetite
Croatian: • pojačan apetit
English: Olanzapine Glenmark Europe has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Croatian: Pokazalo se da Olanzapin Glenmark Europe sprječava ponavljanje tih simptoma u bolesnika s bipolarnim poremećajem u kojih je epizoda manije reagirala na liječenje olanzapinom.
English: Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Croatian: U svakoj su vrsti pronađeni učinci na hematološke parametre, uključujući smanjenje broja cirkulirajućih leukocita ovisno o dozi u miševa te nespecifično smanjenje broja cirkulirajućih leukocita u štakora; međutim, nisu nađeni dokazi citotoksičnosti za koštanu srž.
English: If you suddenly stop taking Olanzapine Glenmark Europe, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Croatian: Ako naglo prestanete uzimati Olanzapin Glenmark Europe mogu se pojaviti simptomi poput znojenja, nesanice, nevoljnog drhtanja, tjeskobe ili mučnine i povraćanja.
English: Reproductive toxicity Olanzapine had no teratogenic effects.
Croatian: Reproduktivna toksičnost Olanzapin nije imao teratogene učinke.
English: You can also place the tablet in a full glass or cup of water or other suitable beverage (orange juice, apple juice, milk or coffee) and stir.
Croatian: Tabletu također možete staviti u čašu punu vode ili drugog prikladnog napitka (sok od naranče, sok od jabuke, mlijeko ili kava) i promiješati.
English: • Inflammation of the pancreas causing severe stomach pain, fever and sickness.
Croatian: • upalu gušterače koja uzrokuje jaku bol u trbuhu, vrućicu i mučninu
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Glenmark Europe unless your doctor tells you to.
Croatian: Ako Vam se simptomi vrate, posavjetujte se sa svojim liječnikom, ali nemojte prestati uzimati Olanzapin Glenmark Europe dok Vam liječnik to ne kaže.
English: • Hypersensitivity (e.g. swelling in the mouth and throat, itching, rash)
Croatian: • preosjetljivost (npr. oticanje u ustima i grlu, svrbež; osip)
English: • Bleeding from the nose.
Croatian: • krvarenje iz nosa; nadimanje trbuha
English: It is important that you carry on taking Olanzapine Glenmark Europe for as long as your doctor tells you.
Croatian: Važno je da nastavite uzimati Olanzapin Glenmark Europe onoliko dugo koliko Vam je liječnik rekao.
English: The daily dose of Olanzapine Glenmark Europe is between 5 mg and 20 mg.
Croatian: Dnevna doza lijeka Olanzapin Glenmark Europe iznosi između 5 mg i 20 mg.
English: Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before the administration.
Croatian: Alternativno se može rastopiti u čaši punoj vode ili drugog prikladnog napitka (sok od naranče, sok od jabuke, mlijeko ili kava) netom prije primjene.
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (- 6.0) versus haloperidol (- 3.1).
Croatian: U multinacionalnom, dvostruko slijepom, komparativnom ispitivanju shizofrenije, shizoafektivnih i povezanih poremećaja, koje je obuhvaćalo 1481 bolesnika s različitim stupnjevima pridruženih simptoma depresije (srednja početna vrijednost 16,6 po Montgomery-Asberg ljestvici depresije), prospektivna sekundarna analiza vrijednosti promjene raspoloženja od početnog do krajnjeg pokazala je statistički značajno poboljšanje (p=0,001) u korist olanzapina (-6,0) naspram haloperidola (-3,1).
English: Special populations Elderly
Croatian: Posebne populacije Stariji bolesnici
English: New born infants exposed to antipsychotics (including olanzapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: U novorođenčadi izloženoj antipsihoticima (uključujući olanzapin) tijekom trećeg tromjesečja trudnoće postoji rizik od nastanka nuspojava, uključujući ekstrapiramidalne simptome i/ili simptome ustezanja koji nakon poroda mogu varirati po težini i trajanju.
English: • diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma
Croatian: • šećernu bolest ili pogoršanje šećerne bolesti, ponekad povezano s ketoacidozom (ketonima u krvi i mokraći) ili komom
English: • Muscle disease presenting as unexplained aches and pains.
Croatian: • bolest mišića koja se manifestira neobjašnjivim bolovima
English: Do not drink any alcohol if you have been given Olanzapine Glenmark Europe as together with alcohol it may make you feel drowsy.
Croatian: Nemojte piti alkohol ako uzimate Olanzapin Glenmark Europe jer u kombinaciji s alkoholom može izazvati omamljenost.
English: Olanzapine Glenmark Europe is used to treat the following conditions:
Croatian: Olanzapin Glenmark Europe koristi se za liječenje sljedećih stanja:
English: High Gamma Glutamyltransferase
Croatian: visoka gama glutamiltransferaza1
English: Olanzapine Glenmark Europe orodispersible tablets should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Croatian: Olanzapin Glenmark Europe raspadljive tablete za usta treba staviti u usta, gdje se brzo rastapa u slini te se može lako progutati.