FrancophonIA/ELRC3.0 huggingface dataset:
English: • In a study of 90 patients newly diagnosed with pemphigus, rituximab in combination with prednisone (a corticosteroid) was shown to be more effective than prednisone alone at clearing skin lesions.
Croatian: • U ispitivanju provedenom na 90 bolesnika kojima je nedavno dijagnostician pemfigus, pokazalo se da je rituksimab u kombinaciji s prednizonom (kortikostereoidom) učinkovitiji od prednizona kao monoterapije u pogledu zacjeljivanja lezija na koži.
English: • In a study of 198 patients with GPA or MPA, 64% of patients given MabThera were in complete remission after six months, compared with 55% given cyclophosphamide, a comparator medicine.
Croatian: • U ispitivanju provedenom na 198 bolesnika s bolestima GPA ili MPA, 64 % bolesnika koji su primali lijek MabThera bili su u potpunoj remisiji nakon šest mjeseci u usporedbi s 55 % bolesnika koji su primali usporedni lijek ciklofosfamid.
English: • severe rheumatoid arthritis (an inflammatory condition of the joints);
Croatian: • teškog reumatoidnog artritisa (upale zglobova);
English: MabThera contains the active substance rituximab.
Croatian: MabThera sadržava djelatnu tvar rituksimab.
English: What benefits of MabThera have been shown in studies?
Croatian: Koje su koristi od lijeka MabThera utvrđene u ispitivanjima?
English: • two inflammatory conditions of blood vessels known as granulomatosis with polyangiitis (GPA or
Croatian: • dvaju upalnih stanja krvnih žila zvanih granulomatoza s poliangitisom (GPA ili Wegenerova granulomatoza) i mikroskopski poliangitis (MPA);
English: • In a studies of MabThera given on its own (203 patients), 48% of the patients with follicular lymphoma who had failed previous treatment responded to MabThera.
Croatian: • U ispitivanjima u kojima se lijek MabThera davao kao monoterapija (203 bolesnika), 48 % bolesnika s folikularnim limfomom koji nisu odgovorili na prethodno liječenje odgovorili su na lijek MabThera.
English: How does MabThera work?
Croatian: Kako djeluje MabThera?
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Croatian: • folikularnog limfoma i difuznog ne-Hodgkinova limfoma velikih B-stanica (dva oblika ne
English: In patients whose disease had come back after previous treatment, those receiving MabThera lived for 30.6 months without their disease getting worse, compared with 20.6 months in those receiving chemotherapy alone.
Croatian: U bolesnika čija se bolest vratila nakon prethodnog liječenja, osobe koje su primale lijek MabThera živjele su 30,6 mjeseci bez pogoršanja bolesti u usporedbi s 20,6 mjeseci osoba koje su primale samo kemoterapiju.
English: • In a maintenance study in patients whose follicular lymphoma had come back after previous treatment, patients who received MabThera alone lived for an average of 42.2 months without the disease getting worse, compared with 14.3 months in patients who did not receive the medicine.
Croatian: • U ispitivanju terapije održavanja u bolesnika kod kojih se folikularni limfom vratio nakon prethodnog liječenja, bolesnici koji su primali samo lijek MabThera živjeli su u prosjeku 42,2 mjeseca bez pogoršanja bolesti u usporedbi s 14,3 mjeseci u bolesnika koji nisu primali lijek.
English: Patients with blood cancers can switch to an injection given under the skin after they have received one full dose of the infusion.
Croatian: Nakon dobivanja jedne pune doze infuzije, bolesnici s rakom krvi mogu prijeći na injekciju koja se daje pod kožu.
English: • In a study of 817 patients with CLL, patients who had not been treated before lived for an average of 39.8 months without their disease getting worse when they received MabThera in addition to chemotherapy, compared with 32.2 months in patients receiving chemotherapy alone.
Croatian: • U ispitivanju provedenom na 817 bolesnika s KLL-om, bolesnici koji nisu prethodno liječeni živjeli su u prosjeku 39,8 mjeseci bez pogoršanja bolesti nakon primanja lijeka MabThera uz kemoterapiju u usporedbi s 32,2 mjeseca u bolesnika koji su primali samo kemoterapiju.
English: • moderate to severe pemphigus vulgaris, an autoimmune disease characterised by widespread blistering and erosion of the skin and mucous membranes (the linings of internal organs).
Croatian: • umjerenog do teškog oblika običnog pemfigusa, autoimune bolesti čije su značajke pojava velikog broja mjehurića i rana na koži i sluznicama (površinski sloj unutarnjih organa). „Autoimuna bolest”
English: • In a study of 399 patients with diffuse large B-cell lymphoma, patients adding MabThera to chemotherapy lived for an average of 35 months without the disease getting worse or the need for a change in treatment, compared with 13 months in those receiving chemotherapy alone.
Croatian: • U ispitivanju provedenom na 399 bolesnika s difuznim limfomom velikih B-stanica, bolesnici kojima je lijek MabThera dodan kemoterapiji živjeli su u prosjeku 35 mjeseci bez pogoršanja bolesti ili potrebe za promjenom liječenja u usporedbi s 13 mjeseci kod onih koji su primali samo kemoterapiju.
English: • In a follicular lymphoma study involving 322 patients, patients receiving MabThera in addition to chemotherapy lived for an average of 25.9 months without the disease coming back, compared with 6.7 months in those receiving chemotherapy alone.
Croatian: • U ispitivanju folikularnog limfoma u koje je bilo uključeno 322 bolesnika, bolesnici koji su primali lijek MabThera uz kemoterapiju živjeli su u prosjeku 25,9 mjeseci bez povratka bolesti u usporedbi sa 6,7 mjeseci kod bolesnika koji su primali samo kemoterapiju.
English: How is MabThera used?
Croatian: Kako se MabThera primjenjuje?
English: For the full list of side effects of MabThera, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom MabThera potražite u uputi o lijeku.
English: MA (EU) Number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Jačina
English: Giovanni Ogna E Figli S.p.A. Viale Zara 23
Croatian: Giovanni Ogna E Figli S.p.A.
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the member states
Croatian: Popis naziva, farmaceutskih oblika, jačine medicinskih proizvoda,
English: It is available as tablets (20, 40 and 80 mg).
Croatian: Dostupan je u tabletama (20, 40 i 80 mg).
English: This summary was last updated in 01-2015.
Croatian: Sažetak je posljednji put ažuriran u 01.2015.
English: If the target blood pressure is not
Croatian: Ako se krvni tlak ne može dostatno
English: The full EPAR for Telmisartan Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Telmisartan Teva nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Croatian: Koristi se u bolesnika koji imaju problema zbog krvnih ugrušaka u prošlosti (poput srčane bolesti, moždanog udara ili arterijske bolesti) ili koji imaju dijabetes tipa 2 koji je oštetio organ (poput očiju, srca ili bubrega).
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Croatian: Također omogućuje srcu da lakše pumpa krv, što pomaže pri smanjivanju rizika od budućih kardiovaskularnih problema.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjeloviti EPAR za referentni lijek nalazi se i na internetskim stranicama Agencije.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Croatian: To omogućuje snižavanje krvnog tlaka, čime se smanjuju rizici povezani s visokim krvnim tlakom, poput moždanog udara.
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 Telmisartan Teva.
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 za uporabu lijeka Telmisartan Teva.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Croatian: Za prevenciju kardiovaskularnih problema, preporučena doza iznosi 80 mg jedanput na dan.
English: For more information about treatment with Telmisartan Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Telmisartan Teva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Telmisartan Teva is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Croatian: Telmisartan Teva se također koristi za sprječavanje kardiovaskularnih problema (problema sa srcem i krvnim žilama) poput srčanog zastoja ili moždanog udara.
English: Telmisartan Teva is a ‘generic medicine'.
Croatian: Telmisartan Teva je "generički lijek".
English: reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Croatian: kontrolirati, doza se može povećati na 80 mg jedanput na dan ili se mogu dodati drugi antihipertenzivi, poput hidroklorotiazida.
English: This means that Telmisartan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Croatian: To znači da je Telmisartan Teva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Micardis.
English: For the treatment of essential hypertension, the recommended dose of Telmisartan Teva is 40 mg once a day, but some patients may benefit from using a 20 mg dose.
Croatian: Za terapiju esencijalne hipertenzije, preporučena doza lijeka Telmisartan Teva iznosi 40 mg jednom na dan, no pojedini bolesnici mogu imati koristi od doze od 20-mg.
English: The active substance in Telmisartan Teva, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Telmisartan, djelatna tvar u lijeku Telmisartan Teva je „antagonist receptora angiotenzina II”, što znači da ova tvar blokira djelovanje hormona u tijelu naziva angiotenzin II.
English: The European Commission granted a marketing authorisation valid throughout the EU for Telmisartan Teva on 26 January 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Telmisartan Teva na snazi u Europskoj uniji od 26. siječnja 2010.
English: What are the benefits and risks of Telmisartan Teva?
Croatian: Koje su koristi i rizici lijeka Telmisartan Teva?
English: This is a summary of the European public assessment report (EPAR) for Telmisartan Teva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Telmisartan Teva.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Croatian: Blokiranjem receptora na koja se angiotenzin II inače veže, telmisartan, sprječava učinak hormona i omogućuje širenje krvnih žila.
English: Telmisartan Teva is a medicine that contains the active substance telmisartan.
Croatian: Telmisartan Teva je lijek koji sadrži djelatnu tvar telmisartan.
English: Because Telmisartan Teva 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 Telmisartan Teva generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day.
Croatian: Bolesnici s ozbiljno smanjenom funkcijom bubrega trebaju primiti manju početnu dozu od 20 mg jednom na dan.
English: The doctor should monitor the patient's blood pressure closely when starting Telmisartan Teva, and may decide to adjust the patient's blood pressure-lowering medication.
Croatian: Prilikom počinjanja terapije lijekom Telmisartan Teva, liječnik treba pratiti pažljivo krvni tlak bolesnika, te može donijeti odluku o prilagođavanju terapije koja služi za snižavanje krvnoga tlaka bolesnika.
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva has been shown to have comparable quality and to be bioequivalent to Micardis.
Croatian: CHMP pri Agenciji zaključio je kako je, u skladu s preduvjetima EU-a, lijek Telmisartan Teva posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Micardis.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Croatian: Bolesnici s blago do umjereno smanjenom funkcijom jetre ne smiju primiti doze veće od 40 mg na dan.
English: Because Telmisartan Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Croatian: Budući da je Telmisartan Teva generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Micardis.
English: The Committee recommended that Telmisartan Teva be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Telmisartan Teva.
English: Why has Telmisartan Teva been approved?
Croatian: Zašto je Telmisartan Teva odobren?
English: What is Telmisartan Teva?
Croatian: Što je Telmisartan Teva?
English: Telmisartan Teva is used in adults who have essential hypertension (high blood pressure).
Croatian: Lijek Telmisartan Teva koristi se u odraslih osoba koje boluju od esencijalne hipertenzije (visokog krvnog tlaka). „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
English: Other information about Telmisartan Teva
Croatian: Ostale informacije o lijeku Telmisartan Teva Pharma:
English: Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Micardis.
English: What is Telmisartan Teva used for?
Croatian: Za što se Telmisartan Teva koristi?
English: How is Telmisartan Teva used?
Croatian: Kako se Telmisartan Teva koristi?
English: How has Telmisartan Teva been studied?
Croatian: Kako je Telmisartan Teva ispitivan?
English: How does Telmisartan Teva work?
Croatian: Kako djeluje Telmisartan Teva?
English: After a 28-day course of treatment, the patient stops treatment for 28 days, before starting another 28-day course.
Croatian: Nakon 28 dana terapije, bolesnik prekida terapiju na 28 dana prije početka novog terapijskog ciklusa od 28 dana.
English: Further information on Vantobra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vantobra
Croatian: Više informacija o lijeku Vantobra nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/vantobra
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Croatian: Preporučena doza je jedna ampula dva puta dnevno, najbolje u razmaku od 12 sati.
English: Vantobra1 (tobramycin)
Croatian: Vantobra1 (tobramicin)
English: Treatment courses may be repeated for as long as the doctor considers the patient to be benefiting from treatment.
Croatian: Ciklusi terapije mogu se ponavljati sve dok liječnik smatra da bolesnik ima koristi od terapije.
English: The Agency noted that safety profile of inhaled tobramycin was well known.
Croatian: Agencija je napomenula da je sigurnosni profil tobramicina za inhalaciju dobro poznat.
English: Vantobra is a ‘hybrid medicine'.
Croatian: Vantobra je „hibridni lijek”.
English: 1 Previously known as Tobramycin PARI.
Croatian: 1 Ranije poznat pod imenom Tobramycin PARI
English: This means that it is similar to a ‘reference medicine' containing the same active substance, tobramycin; however, Vantobra has a higher amount of the active substance.
Croatian: To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar, tobramicin, međutim Vantobra sadrži veću količinu djelatne tvari.
English: However, the following side effects are seen in up to 1 in 100 patients: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore throat) and cough.
Croatian: Međutim, sljedeće su nuspojave zabilježene u 1 na 100 bolesnika: dispneja (otežano disanje), disfonija (promuklost), faringitis (upala grla) i kašalj.
English: What measures are being taken to ensure the safe and effective use of Vantobra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vantobra?
English: Vantobra is therefore easier to use and might help patients to stick to their treatment.
Croatian: Stoga je Vantobra jednostavniji za primjenu i može pomoći bolesnicima da ustraju u terapiji.
English: Side effects reported with Vantobra are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Vantobra pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: If the patient is also receiving other inhaled treatments or chest physiotherapy, it is recommended that Vantobra is used last.
Croatian: Ako bolesnik također prima i druge oblike inhalacijske terapije ili respiratornu fizioterapiju, preporučuje se da se lijek Vantobra primjenjuje posljednji.
English: The results of the study showed that Vantobra can be considered comparable to Tobi.
Croatian: Rezultati ispitivanja pokazali su da se Vantobra može smatrati usporedivim s lijekom Tobi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vantobra 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 Vantobra nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In addition, it takes less time to inhale Vantobra than other tobramycin nebulisers and the time it takes is comparable to the time it takes to inhale the dry powder.
Croatian: Nadalje, potrebno je manje vremena za inhaliranje lijeka Vantobra nego drugih otopina tobramicina za nebulizator, a potrebno vrijeme usporedivo je s vremenom potrebnim za udisanje suhog praška.
English: In addition, a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above determined whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Croatian: Osim toga, ispitivanjem „bioekvivalentnosti”u 58 bolesnika s cističnom fibrozom u dobi od šest godina i starijih ispitivano je proizvodi li lijek Vantobra slične razine djelatne tvari u tijelu kao i referentni lijek Tobi.
English: What is Vantobra and what is it used for?
Croatian: Što je Vantobra i za što se primjenjuje?
English: The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Croatian: Djelatna tvar lijeka Vantobra, tobramicin, spada u skupinu antibiotika poznatih pod nazivom „aminoglikozidi”.
English: Why is Vantobra authorised in the EU?
Croatian: Zašto je Vantobra odobren u EU-u?
English: Other information about Vantobra
Croatian: Ostale informacije o lijeku Vantobra
English: The European Medicines Agency decided that Vantobra's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Vantobra nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The reference medicine for Vantobra is Tobi.
Croatian: Referentni lijek za Vantobra je Tobi.
English: For more information about using Vantobra, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Vantobra pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: What are the risks associated with Vantobra?
Croatian: Koji su rizici povezani s lijekom Vantobra?
English: As for all medicines, data on the use of Vantobra are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Vantobra kontinuirano se prate.
English: An overview of Vantobra and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Vantobra i zašto je odobren u EU-u
English: Cystic fibrosis is an inherited disease in which thick mucus builds up in the lungs that allows bacteria to grow more easily, causing infections.
Croatian: Cistična fibroza nasljedna je bolest pri kojoj se gusta sluz nakuplja u plućima, što pospješuje razvoj bakterija koje uzrokuju infekcije.
English: The Agency noted that inhaled tobramycin was the ‘gold standard' for treating P. aeruginosa infection in patients with cystic fibrosis and that some patients cannot use the dry powder form because of unacceptable side effects.
Croatian: Agencija je napomenula da je inhalirajući tobramicin „zlatni standard” za liječenje infekcija uzrokovanih bakterijom P. aeruginosa u bolesnika s cističnom fibrozom te da neki bolesnici ne mogu primjenjivati lijek u obliku suhog praška zbog neprihvatljivih nuspojava.
English: Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Croatian: Vantobra udiše se pomoću uređaja Tolero nebulizator, koji pretvara otopinu u ampuli u finu paru.
English: For these patients Vantobra, which is inhaled as a solution from a nebuliser, would be a useful alternative.
Croatian: Za te je bolesnike Vantobra, koji se primjenjuje inhaliranjem otopine iz nebulizatora, korisna alternativa.
English: How does Vantobra work?
Croatian: Kako djeluje Vantobra?
English: It works by interfering the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria, which eventually kills them.
Croatian: Djeluje ometajući proizvodnju bjelančevina potrebnih bakteriji P. aeruginosa za izgradnju staničnih ovojnica, što oštećuje bakterije te ih s vremenom ubija.
English: Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.
Croatian: Vantobra je antibiotik za liječenje kroničnih infekcija pluća uzrokovanih bakterijom Pseudomonas aeruginosa u bolesnika u dobi od šest godina i starijih s cističnom fibrozom.
English: Tobramycin has been used for several years to treat P. aeruginosa infection in patients with cystic fibrosis and the applicant submitted data from the literature to support the use of Vantobra.
Croatian: Tobramicin se već nekoliko godina primjenjuje kao terapija za liječenje infekcija uzrokovanih bakterijom P. aeruginosa u bolesnika s cističnom fibrozom te je podnositelj zahtjeva dostavio podatke iz literature u korist primjene lijeka Vantobra.
English: Vantobra is available as a nebuliser solution in single-dose ‘ampoules'.
Croatian: Vantobra dostupan je kao otopina za nebulizator u jednodoznim ampulama.
English: What benefits of Vantobra have been shown in studies?
Croatian: Koje su koristi od lijeka Vantobra utvrđene u ispitivanjima?
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.
Croatian: Bakterija P. aeruginosa česti je uzročnik infekcija u bolesnika s cističnom fibrozom.
English: Side effects with Vantobra are not common.
Croatian: Nuspojave lijeka Vantobra nisu česte.
English: There were no unexpected safety issues with Vantobra.
Croatian: Nisu utvrđeni nikakvi problemi sa sigurnošću primjene lijeka Vantobra.
English: Karlovačka cesta 24a, Zagreb
Croatian: Altamedics d.o.o. Karlovačka cesta 24a, Zagreb