FrancophonIA/ELRC3.0 huggingface dataset:
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. ožujka 2018.
English: Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)
Croatian: Ishod postupka upućivanja u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/089)
English: These included data from companies and from the published literature.
Croatian: Ti su podatci uključivali podatke koje su dostavile tvrtke i podatke iz objavljene literature.
English: It works against a broad spectrum of Gram-negative and Gram-positive bacteria as well as Mycoplasma spp.
Croatian: On djeluje protiv širokog spektra gramnegativnih i gram-pozitivnih bakterija kao i protiv bakterije Mycoplasma spp.
English: What are the conclusions of the CVMP after the follow-up assessment?
Croatian: Koji su zaključci CVMP-a nakon postupka upućivanja?
English: What is enrofloxacin?
Croatian: Što je enrofloksacin?
English: Following review of the relevant information submitted in 2013 (during the initial phase of the referral procedure) and the additional data provided by the marketing authorisation holders as a follow-up of the Commission Implementing Decision (C(2014) 1484), in February 2018 the CVMP concluded that the outstanding concern over optimisation of the dosage regimen for the treatment of Escherichia coli infections was not resolved.
Croatian: Nakon pregleda relevantnih informacija podnesenih 2013. (tijekom početne faze postupka upućivanja) te dodatnih podataka koje su dostavili nositelji odobrenja za stavljanje VMP-a u promet kao dio naknadnog postupanja u skladu s Provedbenom odlukom Komisije (C(2014) 1484), u veljači 2018. CVMP je zaključio da razlozi za zabrinutost u pogledu optimizacije doznog režima za liječenje infekcija bakterijom Escherichia coli nisu otklonjeni.
English: Enrofloxacin is an antibiotic belonging to class ‘fluoroquinolones'.
Croatian: Enrofloksacin je antibiotik koji pripada skupini fluorokinolona.
English: The marketing authorisation holders were advised to contact the National Competent Authorities of the Member States in order to discuss the next steps for the implementation of CVMP's recommended changes to the product information.
Croatian: Nositeljima odobrenja za stavljanje VMP-a u promet preporučeno je da se obrate nacionalnim nadležnim tijelima država članica kako bi razgovarali o daljnjim koracima u provođenju izmjena informacija o VMP-u koje je predložio CVMP.
English: Enrofloxacin is for veterinary use only.
Croatian: Enrofloksacin je namijenjen samo veterinarskoj primjeni.
English: In November 2013, the CVMP made recommendations for these products to ensure that they are used appropriately in chickens and turkeys, and to lower the risk of bacteria developing resistance to enrofloxacin.
Croatian: U studenom 2013. CVMP je izdao preporuke za te proizvode kako bi osigurao da se u kokoši i purana oni pravilno primjenjuju te kako bi se umanjio rizik od razvoja otpornosti bakterija na enrofloksacin.
English: The CVMP has now reviewed these data and has updated its recommendations on the use of enrofloxacin in chickens and turkeys.
Croatian: CVMP je sada pregledao te podatke te je ažurirao svoje preporuke o upotrebi enrofloksacina u kokoši i purana.
English: The CVMP reviewed the available pre-clinical (laboratory) and clinical data (in chickens and turkeys) on enrofloxacin.
Croatian: CVMP je pregledao dostupne nekliničke (laboratorijske) i kliničke podatke (u kokoši i purana) o enrofloksacinu.
English: The CVMP noted that the marketing authorisation holders had not demonstrated that the current dosage regimen for Escherichia coli in chickens and turkeys is optimal from a clinical perspective nor proposed a new dosage regimen.
Croatian: CVMP je napomenuo da nositelji odobrenja za stavljanje VMP-a u promet nisu pokazali da je trenutačni dozni režim za bakteriju Escherichia coli u kokoši i purana optimalan s kliničkog stajališta niti su predložili novi dozni režim.
English: The CVMP considered that the currently-approved dosage may accelerate development of bacterial resistance to enrofloxacin, which would limit its use as treatment of last resort for colibacillosis in poultry.
Croatian: CVMP smatra da trenutačno odobrena doza može ubrzati razvoj otpornosti bakterija na enrofloksacin, što bi ograničilo njegovu primjenu kao terapije posljednjeg izbora za kolibacilozu u peradi.
English: At that time, marketing authorisation holders were required to provide more data to justify the dosage of enrofloxacin used in poultry.
Croatian: U to su vrijeme nositelji odobrenja za stavljanje VMP-a u promet morali dostaviti više podataka radi opravdanja doze enrofloksacina koja se primjenjuje u peradi.
English: EMA/184512/2018
Croatian: Dana 14. veljače 2018.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these products should no longer be used in chickens and turkeys to treat Escherichia coli infections and that the product information for the products should be amended accordingly.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) Agencije za lijekove zaključio je da se ti proizvodi ne smiju više primjenjivati u kokoši i purana za liječenje infekcija bakterijom Escherichia coli te da se informacije o VMP-u trebaju izmijeniti u skladu s tim.
English: Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys
Croatian: Pitanja i odgovori o upotrebi veterinarsko-medicinskih proizvoda koji sadržavaju enrofloksacin i koji se kokošima i puranima daju u vodi za piće
English: Therefore, the CVMP concluded that enrofloxacin should no longer be used for treatment of Escherichia coli infections in chickens and turkeys and recommended that the product information of the concerned products be amended accordingly.
Croatian: Stoga je CVMP zaključio da se enrofloksacin ne smije više upotrebljavati za liječenje infekcija bakterijom Escherichia coli u kokoši i purana te je predložio da se upute o VMP-u za predmetne proizvode izmijene u skladu s tim.
English: Why were enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys reviewed?
Croatian: Zašto su veterinarsko-medicinski proizvodi koji sadržavaju enrofloksacin i koji se kokošima i puranima daju u vodi za piće pregledani?
English: On 14 February 2018, the European Medicines Agency updated its recommendations for enrofloxacincontaining medicines administered via drinking water to chickens and turkeys.
Croatian: Europska agencija za lijekove ažurirala je svoje preporuke o veterinarskomedicinskim proizvodima (VMP) koji sadržavaju enrofloksacin i koji se kokošima i puranima daju u vodi za piće.
English: This summary was last updated in 10-2013.
Croatian: Ovaj sažetak je posljednji put ažuriran: 10.2013.
English: Edarbi must not be used in women who are more than three months pregnant.
Croatian: Edarbi ne smiju uzimati žene koje su trudne dulje od tri mjeseca.
English: Edarbi on its own was more effective than placebo.
Croatian: Edarbi uziman samostalno bio je učinkovitiji od placeba.
English: The studies lasted between six and 56 weeks and the main measure of effectiveness was the change in the systolic blood pressure (blood pressure when the heart is contracting).
Croatian: Ispitivanja su trajala između 6 i 56 tjedana, a glavni pokazatelj djelotvornosti bila je promjena sistoličkog krvnog tlaka (krvni tlak u trenutku kontrakcije srca).
English: Edarbi is taken by mouth and the usual recommended dose is 40 mg once a day.
Croatian: Edarbi se uzima kroz usta i uobičajena preporučena doza je 40 mg jedanput na dan.
English: The full EPAR for Edarbi 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 Edarbi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Its use during the first three months of pregnancy is also not recommended.
Croatian: Ne preporuča se primjena u žena tijekom prva tri mjeseca trudnoće.
English: This allows the blood pressure to fall towards normal, thus reducing the risks associated with high blood pressure, such as having a stroke.
Croatian: To omogućuje snižavanje krvnog tlaka na normalnu razinu, čime se smanjuju rizici povezani s visokim krvnim tlakom, poput moždanog udara.
English: What measures are being taken to ensure the safe and effective use of Edarbi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Edarbi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Edarbi on 07 December 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Edarbi na snazi u Europskoj uniji od 7. prosinca 2011.
English: Edarbi azilsartan medoxomil
Croatian: Edarbi azilsartanmedoksomil
English: The studies also showed that Edarbi, when taken in combination with other medicines, can produce additional decreases in blood pressure compared with when these medicines are taken without Edarbi.
Croatian: Ispitivanja su također pokazala da Edarbi, kada se uzima u kombinaciji s drugim lijekovima, doprinosi dodatnom smanjenju krvnog tlaka u usporedbi kada se takvi lijekovi uzimaju bez lijeka Edarbi.
English: Other information about Edarbi
Croatian: Ostale informacije o lijeku Edarbi
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 80 mg, or another medicine for hypertension, such as chlortalidone or hydrochlorothiazide, can be added.
Croatian: Ako se krvni tlak ne može kontrolirati na odgovarajući način, doza se može povećati na 80 mg ili se može dodati i drugi lijek za visoki krvni tlak, primjerice klortalidon ili hidroklorotiazid.
English: This is a summary of the European public assessment report (EPAR) for Edarbi.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Edarbi.
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 Edarbi.
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 te preporuke o uvjetima za primjenu lijeka Edarbi.
English: Edarbi 40 and 80 mg was also more effective than ramipril (10 mg).
Croatian: Lijek Edarbi u dozama od 40 i 80 mg također se pokazao učinkovitijim od ramiprila (10 mg).
English: A risk management plan has been developed to ensure that Edarbi is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Edarbi.
English: What is the risk associated with Edarbi?
Croatian: Koji su rizici povezani s lijekom Edarbi?
English: For more information about treatment with Edarbi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Edarbi pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The active substance in Edarbi, azilsartan medoxomil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Djelatna tvar u lijeku Edarbi, azilsartanmedoksomil, je „antagonist receptora angiotenzina II”, što znači da u tijelu blokira djelovanje hormona angiotenzina II.
English: In the two studies with Edarbi taken alone compared with placebo, patients had an average fall in systolic blood pressure of about 13.5 mmHg on Edarbi 40 mg and a fall of about 14.5 mmHg on Edarbi 80 mg after 6 weeks.
Croatian: U dva ispitivanja u kojima se Edarbi uzimao samostalno, u usporedbi s placebom, kod bolesnika je zabilježen prosječan pad sistoličkog krvnog tlaka od 13,5 mmHg pri uzimanju 40 mg lijeka Edarbi i 14,5 mmHg pri uzimanju 80 mg tijekom 6 tjedana.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edarbi, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Edarbi nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: When Edarbi alone was compared with other medicines, 80 mg of Edarbi was more effective in lowering blood pressure than the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg).
Croatian: Kada se samostalna uporaba lijeka Edarbi uspoređivala s drugim lijekovima, doza od 80 mg lijeka Edarbi bila je učinkovitija u snižavanju krvnog tlaka od najviše odobrene doze valsartana (320 mg) i olmesartanmedoksomila (40 mg).
English: Three studies investigated the effects of Edarbi in combination with other antihypertensive medicines (chlortalidone, amlodipine, and hydrochlorothiazide).
Croatian: U tri ispitivanja istraživali su se učinci lijeka Edarbi u kombinaciji s drugim antihipertenzivima (klortalidon, amlodipin i hidroklorotiazid).
English: Edarbi must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with diabetes or in patients with moderate or severe kidney impairment.
Croatian: Edarbi se ne smije uzimati u kombinaciji s lijekovima koji sadrže aliskiren (također se koristi za liječenje esencijalne hipertenzije) kod bolesnika s dijabetesom ili umjerenim do teškim oštećenjem bubrega.
English: Why has Edarbi been approved?
Croatian: Zašto je Edarbi odobren?
English: The CHMP concluded that Edarbi belongs to an established class of medicines in the treatment of hypertension and its risks are similar to others within this class.
Croatian: Odbor za lijekove za humanu uporabu zaključilo je da Edarbi pripada poznatoj klasi lijekova za liječenje hipertenzije i da su povezani rizici slični onima drugih lijekova iz iste klase.
English: The patients in the combination studies had moderate to severe hypertension.
Croatian: Bolesnici koji su sudjelovali u ispitivanjima kombinacije lijekova imali su umjerenu do tešku hipertenziju.
English: The patients in these studies had mild to moderate hypertension.
Croatian: Bolesnici koji su sudjelovali u ovim ispitivanjima imali su blagu do umjerenu hipertenziju.
English: Side effects with Edarbi are generally mild or moderate, with the most common side effect being dizziness.
Croatian: Nuspojave uz Edarbi uglavnom su blage do umjerene, a najčešća nuspojava je omaglica.
English: By blocking the receptors to which angiotensin II normally attaches, azilsartan medoxomil stops the hormone from having an effect,
Croatian: Blokiranjem receptora na koje se angiotenzin II inače veže, azilsartanmedoksomil sprječava učinak hormona i omogućuje širenje krvnih žila.
English: What is Edarbi?
Croatian: Što je Edarbi?
English: Eight main studies involving over 6,000 patients with essential hypertension were carried out with Edarbi.
Croatian: Lijek Edarbi ispitan je u osam glavnih ispitivanja na više od 6000 bolesnika s esencijalnom hipertenzijom.
English: Five studies investigated the effects of Edarbi taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil).
Croatian: U pet ispitivanja istraživali su se učinci lijeka Edarbi kada se uzima samostalno, u usporedbi s placebom (prividnim liječenjem) ili s drugim antihipertenzivima (ramipril, valsartan i olmesartanmedoksomil).
English: Edarbi is a medicine that contains the active substance azilsartan medoxomil.
Croatian: Edarbi je lijek koji sadrži azilsartanmedoksomil kao djelatnu tvar.
English: The Committee decided that the benefits of Edarbi are greater than its risks in patients with essential hypertension and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Edarbi nadmašuju rizike kod bolesnika s esencijalnom hipertenzijom te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What benefit has Edarbi shown during the studies?
Croatian: Koje su koristi lijeka Edarbi dokazane u ispitivanjima?
English: What is Edarbi used for?
Croatian: Za što se Edarbi koristi?
English: ‘Essential' means that the hypertension has no obvious cause.
Croatian: Edarbi se koristi za liječenje esencijalne hipertenzije (visokog krvnog tlaka) u odraslih osoba. „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
English: For the full list of all side effects reported with Edarbi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Edarbi potražite u uputi o lijeku.
English: This compares with a fall of 0.3 to 1.4 mmHg in the patients taking placebo.
Croatian: U bolesnika koji su uzimali placebo tlak je bio niži od 0,3 mmHg do 1,4 mmHg.
English: How is Edarbi used?
Croatian: Kako se Edarbi koristi?
English: How does Edarbi work?
Croatian: Kako djeluje Edarbi?
English: How has Edarbi been studied?
Croatian: Kako je Edarbi ispitivan?
English: Advice/medical education
Croatian: Savjetovanje / medicinska edukacija
English: Consequently, to preserve the efficacy of this drug:
Croatian: Prema tome, kako bi se očuvala djelotvornost ovog lijeka:
English: Several genetic elements and multiple mutations are required.
Croatian: Potrebno je nekoliko genetičkih elemenata i višestrukih mutacija.
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Provjerite s liječnikom ako niste sigurni.
English: Stopping the infusion usually results in a prompt cessation of these reactions.
Croatian: Zaustavljanje infuzije obično rezultira brzim prestankom ovih reakcija.
English: What Vancomycin is and what it is used for
Croatian: Što je Vankomicin i za što se koristi
English: Your doctor will decide how much of this medicine you should receive each day and how long the treatment will last.
Croatian: Vaš liječnik će odlučiti koliko ovog lijeka trebate primiti svaki dan i koliko dugo će liječenje trajati.
English: It is usually given every 6 hours.
Croatian: Obično se daje svakih 6 sati.
English: Species for which acquired resistance may be a problem
Croatian: Vrste kod kojih stečena rezistencija može predstavljati problem
English: If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Croatian: Ako je Vaš liječnik propisao antibiotike, potrebni su Vam isključivo za Vašu trenutnu bolest.
English: Secondary development of resistance during therapy is rare.
Croatian: Sekundarni razvoj rezistencije tijekom terapije je rijedak.
English: Swallow the capsules whole with water.
Croatian: Progutajte cijele kapsule s vodom.
English: Despite antibiotics, some bacteria may survive or grow.
Croatian: Unatoč antibioticima, neke bakterije mogu preživjeti ili dalje rasti.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzimajte ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: 2 - Strictly follow the prescription.
Croatian: 2 - Strogo slijedite propisane upute.
English: 4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
Croatian: 4 - Nikada nemojte davati Vaš antibiotik drugoj osobi; možda nije prikladan za njegovu/njezinu bolest.
English: The safety profile is generally consistent among children and adult patients.
Croatian: Sigurnosni profil je generalno konzistentan kod primjene u djece i odraslih bolesnika.
English: 3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
Croatian: 3 - Nemojte ponovno koristiti antibiotik bez liječničkog recepta, čak i ako želite liječiti sličnu bolest.
English: Transient or permanent loss of hearing
Croatian: Prolazni ili trajni gubitak sluha
English: The capsule should not be open and should be taken with plenty of water.
Croatian: Kapsula se ne smije otvarati i potrebno ju je uzeti s dovoljno vode.
English: [to be completed nationally]
Croatian: [Popunjava se na nacionalnoj razini]
English: Careful observation of the patient is essential.
Croatian: Neophodno je pažljivo praćenje bolesnika.
English: Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
Croatian: Drugi oblici ovog lijeka su možda prikladniji za djecu; obratite se Vašem liječniku ili ljekarniku.
English: They are ineffective against viral infections.
Croatian: Oni su neučinkoviti protiv virusnih infekcija.
English: Adults and children
Croatian: Odrasli i djeca
English: It is usually given every 8 to 12 hours.
Croatian: Obično se daje svakih 8 do 12 sati.
English: - your hearing ability, - any other medicines you may be taking.
Croatian: - funkciji sluha, - drugim lijekovima koje uzimate.
English: Biliary excretion is insignificant (less than 5% of a dose).
Croatian: Izlučivanje putem žuči je beznačajno (manje od 5 % doze).
English: 10 to 21 days
Croatian: 10 do 21 dana
English: 5 - After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly.
Croatian: 5 - Nakon završetka liječenja vratite sve neiskorištene lijekove u ljekarnu kako bi se osiguralo njihovo pravilno zbrinjavanje.
English: Acute bacterial meningitis (For parenteral formulations authorised for Acute bacterial meningitis)
Croatian: Akutni bakterijski meningitis (Za parenteralne formulacije odobrene za akutni bakterijski meningitis)
English: Suggested treatment duration is shown in table below.
Croatian: Predloženo trajanje liječenja prikazano je u sljedećoj tablici.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, u skladu s postupcima navedenim u Poglavlju 4 Glave III Direktive 2001/83/EZ.
English: This preparation is for oral use only and is not systemically absorbed.
Croatian: Ovaj je pripravak namijenjen samo za peroralnu primjenu i ne apsorbira se sistemski.
English: Potential for Systemic Absorption
Croatian: Potencijal za sistemsku apsorpciju
English: Your doctor, or nurse, will always give vancomycin into your blood and not in the muscle.
Croatian: Vaš liječnik ili medicinska sestra će uvijek primijeniti vankomicin u krv, a ne u mišiće.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Vrlo često (≥ 1/10); često (≥ 1/100 i <1/10); manje često (≥ 1/1000 i <1/100); rijetko (≥ 1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The length of treatment depends on the infection you have and may last a number of weeks.
Croatian: Duljina liječenja ovisi o infekciji od koje bolujete i može trajati nekoliko tjedana.
English: 1 - Use antibiotics only when prescribed.
Croatian: 1 - Koristite antibiotike samo kada je propisano.
English: Summary of the Safety profile
Croatian: Sažetak sigurnosnog profila
English: In anephric patients, the mean half-life is 7.5 days.
Croatian: U anefričnih bolesnika prosječno vrijeme poluživota je 7,5 dana.
English: You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate: - dosage - schedules - duration of treatment
Croatian: Možete čak pridonijeti tome da bakterije postanu otporne i time usporiti Vaše liječenje ili smanjiti učinkovitost antibiotika ako ne poštujete odgovarajuću: - dozu - raspored uzimanja lijeka - trajanje liječenja