FrancophonIA/ELRC3.0 huggingface dataset:
English: For this indication in moderate and high risk surgical patients the CHMP considered that the SmPC should reflect that individual thromboembolic risk for patients can be estimated using a validated risk stratification model.
Croatian: U pogledu ove indikacije, CHMP je utvrdio da bi se u sažecima opisa svojstava trebalo naznačiti da se u bolesnika s umjerenim i visokim rizikom koji se podvrgavaju kirurškom zahvatu može procijeniti pojedinačni rizik od tromboembolije na temelju provjerenog modela za stratifikaciju rizika.
English: On the other hand, other low molecular weight heparins (LMWHs) in most European MSs are mainly expressed in IU of activity anti Xa and not in mg, which is in line with the European Pharmacopoeia (Version 8.1, 2014), which expresses the strength of heparins, including LWMH in IU of activity anti Xa.
Croatian: S druge strane, drugi heparini niske molekularne težine (LMWH) u većini država članica EU-a uglavnom se izražavaju pomoću IU aktivnosti anti-Xa, a ne u miligramima.
English: The treatment of UA and NSTEMI was not authorised in all Member States prior to the finalisation of this referral.
Croatian: Liječenje nestabilne angine i infarkta miokarda bez ST elevacije nije ovlašteno u svim državama članicama prije zaključivanja ovog upućivanja.
English: A consistent wording has been approved on platelet count monitoring to take into account current international guidelines, in order to avoid unnecessary monitoring in patients at low risk of HIT. Other changes were made to complement the information already present in other parts of the product information:
Croatian: Odobren je dosljedan tekst o praćenju broja trombocita kako bi se u obzir uzele trenutačne međunarodne smjernice i kako bi se izbjegao nepotreban nadzor bolesnika s niskim rizikom od trombocitopenije izazvane heparinom.
English: Treatment of deep venous thromboembolism
Croatian: Liječenje duboke venske tromboembolije
English: Treatment of DVT and pulmonary embolism PE
Croatian: Liječenje duboke venske tromboze i plućne embolije
English: Prophylaxis of venous thromboembolic disease
Croatian: Profilaksa venske tromboembolije
English: However, no further important differences exist for the haemodialysis indication in the national SmPCs approved in the EU MSs.
Croatian: Međutim, u nacionalnim sažecima opisa svojstava lijeka koji su odobreni u državama članicama EU-a ne postoje druge značajne razlike za indikaciju hemodijalize.
English: Some disharmonies existed further in terms of the timing of enoxaparin administration in this indication, which were aligned as part of the procedure.
Croatian: U ovoj indikaciji postojala su određena neslaganja u vezi s vremenom primjene enoksaparina.
English: Prophylaxis of venous thromboembolism (VTE) in surgical patients
Croatian: Profilaksa venske tromboembolije u bolesnika koji se podvrgavaju kirurškom zahvatu
English: o or as twice daily injections of 100 IU/kg (1 mg/kg): used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Croatian: • Doziranje za liječenje duboke venske tromboze i plućne embolije objašnjeno je na sljedeći način: enoksaparin-natrij može se primijeniti supkutano: o kao injekcija od 150 IU/kg (1.5 mg/kg) jednom dnevno: koristi se u bolesnika bez komplikacija s niskim rizikom od vraćanja VTE-a, o ili injekcija od 100 IU/kg (1 mg/kg) dvaput dnevno: koristi se u svih drugih bolesnika kao što su bolesnici s pretilošću, simptomatskom plućnom embolijom, rakom, ponavljajućim VTE-om ili proksimalnom trombozom (vena ilijaka).
English: The CHMP agreed to use this definition in the enoxaparin labelling, and the indication was harmonised to include treatment of unstable angina and NSTEMI administered concurrently with oral acetylsalicylic acid.
Croatian: Indikacija je usklađena tako da sadrži liječenje nestabilne angine i infarkta miokarda bez ST elevacije koji se primjenjuje u kombinaciji s acetilsalicilatnom kiselinom.
English: • A contraindication in patients with severe renal impairment (creatinine clearance < 30 ml/min) that existed in some EU member states was removed from the Product Information, however, use in patients with end stage kidney disease (creatinine clearance <15 ml/min) is not recommended outside the prevention of thrombus formation in dialysis patients.
Croatian: • Kontraindikacija u bolesnika s ozbiljnim oštećenjem jetre (klirens kreatinina < 30 ml/min) koja je postojala u nekim državama članicama EU-a uklonjena je iz informacija o lijeku,
English: Prophylaxis of VTE in medical patients
Croatian: Profilaksa venske tromboembolije u bolesnika
English: It is available as tablets (2.5, 5, 7.5, 10, 15 and 20 mg).
Croatian: Dostupan je kao tablete (2,5, 5, 7,5, 10, 15 i 20 mg).
English: This summary was last updated in 07-2014.
Croatian: Sažetak je posljednji put ažuriran: 07. 2014.
English: The recommended starting dose of Olanzapine Glenmark depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Croatian: Preporučena početna doza Olanzapine Glenmark ovisi o bolesti koja se liječi: 10 mg na dan koristi u liječenju shizofrenije i prevenciji epizoda manije, a 15 mg na dan koristi se u liječenju epizoda manije, osim ako se ne koristi zajedno s drugim lijekovima, te u tom slučaju početna doza može biti 10 mg na dan.
English: The full EPAR for Olanzapine Glenmark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Olanzapine Glenmark nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Olanzapine Glenmark is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Croatian: Olanzapine Glenmark je također djelotvoran u održavanju poboljšanja u bolesnika koji su pokazali početni odgovor na liječenje.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olanzapine Glenmark.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke u vezi s uvjetima za uporabu lijeka Olanzapine Glenmark.
English: For more information about treatment with Olanzapine Glenmark, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Olanzapine Glenmark pročitajte u uputi lijeka (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: This means that Olanzapine Glenmark is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Croatian: To znači da je Olanzapine Glenmark sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Zyprexa.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Olanzapine Glenmark.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark on 3 December 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Olanzapine Glenmark vrijedi na prostoru Europske unije od 03. prosinca 2009.
English: Because Olanzapine Glenmark is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Olanzapine Glenmark generički lijek te je bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Olanzapine Glenmark olanzapine
Croatian: Olanzapine Glenmark olanzapin
English: Olanzapine Glenmark is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Croatian: Olanzapine Glenmark je indiciran za liječenje umjerenih do teških epizoda manije (ekstremno dobrog raspoloženja) u odraslih osoba.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Glenmark has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Croatian: CHMP je zaključio kako je, u skladu s preduvjetima EU-a, potvrđeno kako Olanzapine Glenmark posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Zyprexa.
English: Other information about Olanzapine Glenmark
Croatian: Druge informacije o Olanzapine Glenmark
English: Olanzapine Glenmark is a ‘generic medicine'.
Croatian: Olanzapine Glenmark je „generički lijek”.
English: The active substance in Olanzapine Glenmark, olanzapine, is an antipsychotic medicine.
Croatian: Djelatna tvar lijeka Olanzapine Glenmark, olanzapin, je antipsihotik.
English: The Committee recommended that Olanzapine Glenmark be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Olanzapine Glenmark.
English: Because Olanzapine Glenmark is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine Zyprexa.
Croatian: Budući da je Olanzapine Glenmark generički lijek, ispitivanja na bolesnicima bile su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Zyprexa.
English: Olanzapine Glenmark is a medicine containing the active substance olanzapine.
Croatian: Olanzapine Glenmark je lijek koji sadrži djelatnu tvar olanzapin.
English: What are the benefits and risks of Olanzapine Glenmark?
Croatian: Koje su koristi i rizici lijeka Olanzapine Glenmark?
English: Olanzapine Glenmark is used to treat adults with schizophrenia.
Croatian: Olanzapine Glenmark se koristi za liječenje shizofrenije u odraslih osoba.
English: What is Olanzapine Glenmark?
Croatian: Što je Olanzapine Glenmark?
English: Why has Olanzapine Glenmark been approved?
Croatian: Zašto je lijek Olanzapine Glenmark odobren?
English: What is Olanzapine Glenmark used for?
Croatian: Za što se Olanzapine Glenmark koristi?
English: How is Olanzapine Glenmark used?
Croatian: Kako se Olanzapine Glenmark koristi?
English: How has Olanzapine Glenmark been studied?
Croatian: Kako je Olanzapine Glenmark ispitivan?
English: How does Olanzapine Glenmark work?
Croatian: Kako djeluje Olanzapine Glenmark?
English: Yes.
Croatian: Da.
English: Did you know?
Croatian: Jeste li znali?
English: Frequently asked questions
Croatian: Česta pitanja
English: Are my personal data protected?
Croatian: Jesu li moji osobni podaci zaštićeni?
English: What happens to my report after I've sent it?
Croatian: Što se događa s mojom prijavom nakon što ju pošaljem?
English: Patients' organisations in your country may also be able to help.
Croatian: Udruge bolesnika u Vašoj državi mogu također pružiti pomoć.
English: What information should I report?
Croatian: Koje informacije trebam prijaviti?
English: If possible, you should provide the following information when making your report:
Croatian: Ako je moguće, prilikom prijave trebate dostaviti sljedeće informacije:
English: All personal information related to the reporting of a side effect is processed in accordance with EU data protection legislation.
Croatian: Svi osobni podaci povezani s prijavom nuspojave obrađuju se u skladu sa zakonodavstvom Europske unije o zaštiti podataka.
English: You can also check the publicly available European database (www.adrreports.eu) or contact your national medicines authority for further information.
Croatian: Možete također provjeriti javno dostupnu europsku bazu podataka (www.adrreports.eu) ili za više informacija kontaktirati nacionalnu agenciju.
English: What does this mean?
Croatian: Što znači ova oznaka?
English: You can report side effects yourself
Croatian: Nuspojave možete prijaviti i sami
English: • the batch number of the medicine (found on the packaging);
Croatian: • broj serije lijeka (nalazi se na pakiranju);
English: • information on the person who has had the side effect (such as age and sex);
Croatian: • informacije o osobi koja je doživjela nuspojavu (poput dobi i spola);
English: How do I know I've experienced a side effect?
Croatian: Kako mogu znati da sam doživio/ doživjela nuspojavu?
English: For more details, and to report online, please check the website of your national authority (use these links to ensure you are reporting to the appropriate website).
Croatian: Za više informacija i postupak on-line prijave molimo posjetite internetsku stranicu svoje nacionalne agencije (upotrijebite ovu poveznicu kako biste osigurali da prijavljujete na odgovarajućoj internetskoj stranici).
English: A side effect (also called an adverse reaction) is an unwanted symptom or effect caused by a medicine.
Croatian: Nuspojava (također se naziva i neželjenom reakcijom) je neželjeni simptom ili učinak uzrokovan lijekom.
English: Your report is used solely for the scientific evaluation of the medicine.
Croatian: Vaša se prijava koristi isključivo za potrebe znanstvene ocjene lijeka.
English: Your doctor or pharmacist can help you complete your report, and you can also request that they send the report on your behalf.
Croatian: Vaš liječnik ili ljekarnik može Vam pomoći pri popunjavanju prijave te možete zatražiti da u Vaše ime pošalju prijavu.
English: The symbol does not mean that your medicine is unsafe.
Croatian: Ovaj simbol ne znači da lijek nije siguran za primjenu.
English: Where can I find information on side effects that have already been reported with the medicine?
Croatian: Gdje mogu pronaći informacije o nuspojavama koje su već prijavljene za lijek?
English: You can usually report side effects by filling in a form online or from your doctor or local pharmacy.
Croatian: Uobičajeno, nuspojavu možete prijaviti ispunjavanjem on-line obrasca ili putem svojeg liječnika ili lokalne ljekarne.
English: The inverted black triangle symbol '▼' serves as a reminder to report any suspected side effects, either because the medicine is new or because there is a particular need to find out more about its long-term safety.
Croatian: Simbol obrnutog crnog trokut '▼' služi kao podsjetnik za prijavu svih sumnji na nuspojave zato što je lijek nov ili zato što postoji posebna potreba za dodatnih prikupljanjem informacija o njegovoj dugoročnoj sigurnosti.
English: Your report, along with other reports on the medicine, will be reviewed by medicines safety experts to see if there is any new information (known as a 'safety signal').
Croatian: Vašu prijavu, kao i ostale prijave vezane uz lijek, pregledat će stručnjaci za sigurnu primjenu lijeka kako bi utvrdili postoje li bilo kakve nove informacije (poznate pod nazivom „sigurnosni signal“).
English: Although they are tested extensively in clinical trials before they are authorised, not everything can be known about their side effects until they have been used by many people over time.
Croatian: Iako se prije odobravanja lijekove iscrpno ispituje u kliničkim ispitivanjima, nije moguće saznati sve o njihovim nuspojavama sve dok ih ne koristi veliki broj ljudi tijekom duljeg vremenskog razdoblja.
English: After evaluating the safety signal and all other relevant data, medicines authorities may issue new warnings or advice on how the medicine should be used, and can even stop its use.
Croatian: Nakon procjene sigurnosnog signala i svih ostalih relevantnih podataka, nadležno tijelo može izdati nova upozorenja i savjete o načinu primjene lijeka, te može čak i prekinuti njegovu primjenu.
English: You cannot always be certain that what you are experiencing is caused by the medicine, but by reporting suspected side affects you can help the authorities in their investigations, which will lead to safer medicines.
Croatian: Ne možete uvijek biti sigurni da je ono što doživljavate uzrokovano lijekom, no prijavom sumnji na nuspojave pomažete nadležnim tijelima u njihovim istragama, što će rezultirati sigurnijim lijekovima.
English: As a patient, you have the right to report unwanted side effects of medicines directly to the authorities.
Croatian: Kao bolesnik imate pravo prijaviti neželjene nuspojave lijeka izravno nadležnim tijelima.
English: • any other health conditions that the person who experienced the side effect may have.
Croatian: • bilo kakvo drugo zdravstveno stanje koje je prisutno u osobe koja je doživjela nuspojavu.
English: You can also report a side effect on behalf of someone in your care, such as a child or relative.
Croatian: Nuspojave možete prijaviti i u ime osobe o kojoj skrbite, primjerice djeteta ili člana obitelji.
English: If you are worried about any suspected side effects from your medicine, please speak to your doctor or pharmacist for advice.
Croatian: Ako ste zabrinuti zbog sumnje na nuspojavu lijeka, molimo obratite se Vašem liječniku ili ljekarniku za savjet.
English: • the description of the side effect;
Croatian: • opis nuspojave;
English: We are always learning more about medicines.
Croatian: Naša znanja o lijekovima se kontinuirano proširuju.
English: Why report a side effect?
Croatian: Zašto prijaviti nuspojavu?
English: Remember to speak to your doctor or pharmacist if you are worried about any suspected side effects.
Croatian: Svakako se obratite liječniku ili ljekarniku ako ste zabrinuti zbog sumnje na nuspojavu.
English: The medicine has a black triangle symbol in its package leaflet.
Croatian: Lijek je označen simbolom crnog trokuta u uputi o lijeku.
English: • the dose and the name of the medicine suspected to have caused the side effect (brand name as well as active ingredient);
Croatian: • dozu i naziv lijeka za koji se sumnja da je uzrokovao nuspojavu (zaštićeni naziv kao i djelatnu tvar);
English: Can I get help with reporting a side effect?
Croatian: Može li mi netko pomoći pri prijavi nuspojave?
English: • any other medicines being taken around the same time (including non-prescription medicines,
Croatian: • podatke o svim ostalim lijekovima u istovremenoj primjeni (uključujući i lijekove koji se izdaju bez liječničkog recepta, biljne pripravke i kontracepcijska sredstva);
English: You should contact them immediately if you have a side effect that you think is serious or that is listed as serious in the package leaflet that comes with your medicine.
Croatian: Morate se odmah obratiti liječniku ili ljekarniku ako ste doživjeli nuspojavu koju smatrate ozbiljnom ili koja je navedena kao ozbiljna u uputi o lijeku koja je priložena lijeku.
English: By reporting side effects, you can help to provide more information about medicines, which will ultimately help to make them safer.
Croatian: Prijavljivanjem nuspojava pomažete pri prikupljanju informacija o lijeku, što naposljetku čini primjenu lijekova sigurnijom.
English: How do I report a side effect?
Croatian: Kako mogu prijaviti nuspojavu?
English: If you think a medicine has caused a side effect, please check the package leaflet that comes with the medicine for information on how to report it.
Croatian: Ako sumnjate da je lijek uzrokovao nuspojavu, molimo pročitajte informacije o načinu prijave nuspojava u uputi o lijeku koja je priložena lijeku.
English: You can check the package leaflet that comes with the medicine.
Croatian: Pročitajte uputu o lijeku koja je priložena lijeku.
English: The capsules should be taken with food, preferably at the same time every day.
Croatian: Kapsule bi trebalo uzimati s hranom, po mogućnosti u isto vrijeme svakoga dana.
English: This medicine is identical to Urorec, which has been authorised in the EU since 29 January 2010.
Croatian: Ovaj je lijek identičan lijeku Urorec, odobrenom u EU-u od 29. siječnja 2010.
English: In two of the studies the IPSS was around 21 points at the start of the study.
Croatian: U dvama ispitivanjima IPSS je iznosio otprilike 21 bod na početku ispitivanja.
English: This may be increased to 8 mg once a day after a week.
Croatian: Doza se može povećati na 8 mg jednom na dan nakon tjedan dana.
English: Further information on Silodosin Recordati can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
Croatian: Više informacija o lijeku Silodosin Recordati možete naći na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
English: Silodosin Recordati (silodosin) EMA/815843/2018
Croatian: Silodosin Recordati (silodozin) EMA/815843/2018
English: For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Croatian: Za muškarce s umjerenim problemima s bubrezima početna bi doza trebala iznositi 4 mg jednom na dan.
English: The recommended dose is one 8 mg capsule once a day.
Croatian: Preporučena doza je jedna kapsula od 8 mg jedanput na dan.
English: The symptoms were measured using the international prostate symptom score (IPSS).
Croatian: Simptomi su mjereni s pomoću Međunarodnog indeksa simptoma prostate (IPSS).
English: Silodosin Recordati can only be obtained with a prescription and is available as capsules (4 and 8 mg).
Croatian: Silodosin Recordati izdaje se samo na liječnički recept i dostupan je u obliku kapsula (od 4 mg i 8 mg).
English: The most common side effect with Silodosin Recordati (which may affect more than 1 in 10 people) is a reduction in the amount of semen released during ejaculation.
Croatian: Najčešća nuspojava lijeka Silodosin Recordati (koja se može javiti u više od 1 na 10 osoba) je smanjenje količine sjemena koje se otpušta tijekom ejakulacije).
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Croatian: Blokiranjem tih receptora silodozin omogućuje opuštanje mišića, čime se olakšava prolazak urina i ublažavaju se simptomi BHP-a.
English: After 12 weeks, the IPSS fell by 6.4 points in the men who took Silodosin Recordati compared with 3.5 points in the men who took placebo (a dummy treatment).
Croatian: Nakon 12 tjedana IPSS je pao za 6,4 boda u muškaraca koji su uzimali lijek Silodosin Recordati, u usporedbi s 3,5 bodova u muškaraca koji su uzimali placebo (prividno liječenje).
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Croatian: Kada se aktiviraju ti receptori, uzrokuju kontrakcije mišića koji kontroliraju protok urina.
English: Side effects reported with Silodosin Recordati are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Silodosin Recordati pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Silodosin Recordati (silodosin)
Croatian: Silodosin Recordati (silodozin)
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silodosin Recordati have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Silodosin Recordati nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In the third study, the IPSS was around 19 points before treatment and fell by 7 points with Silodosin Recordati compared with 6.7 points in men who took tamsulosin (another medicine used for BPH) and 4.7 points with placebo.
Croatian: U trećem ispitivanju IPSS je iznosio otprilike 19 bodova prije liječenja i pao je za 7 bodova s primjenom lijeka Silodosin Recordati, u usporedbi sa 6,7 bodova u muškaraca koji su uzimali tamzulozin (drugi lijek za liječenje BHP-a) te 4,7 bodova s placebom.
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Croatian: Intraoperacijski sindrom meke šarenice (IFIS) javlja se u nekih bolesnika koji uzimaju antagoniste α-adrenergičkih receptora i može dovesti do komplikacija tijekom operacije katarakte.