FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Pregabalin Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Pregabalin Mylan pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: The Committee recommended that Pregabalin Mylan be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Pregabalin Mylan u promet u EU-u.
English: It is not intended to provide practical advice on how to use Pregabalin Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pregabalin Mylan.
English: For practical information about using Pregabalin Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pregabalin Mylan bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da njegova korist nadmašuje identificirani rizik, kao i kod lijeka Lyrica.
English: Other information about Pregabalin Mylan
Croatian: Ostale informacije o lijeku Pregabalin Mylan
English: Pregabalin Mylan contains the active substance pregabalin.
Croatian: Pregabalin Mylan sadrži djelatnu tvar pregabalin.
English: Why is Pregabalin Mylan approved?
Croatian: Zašto je lijek Pregabalin Mylan odobren?
English: How is Pregabalin Mylan used?
Croatian: Kako se Pregabalin Mylan koristi?
English: How has Pregabalin Mylan been studied?
Croatian: Kako je Pregabalin Mylan ispitivan?
English: How does Pregabalin Mylan work?
Croatian: Kako djeluje Pregabalin Mylan?
English: --1 Live myxoma vectored rabbit haemorrhagic disease (RHD) virus: Strain 009: ≥103.0 and ≤105.8 FFU* Strain MK1899: ≥103.0 and ≤105.8 FFU* *Focus Forming Units
Croatian: --1 Živi miksoma virus, vektorski RHD: soj 009: ≥103,0 i ≤105,8 FFU* soj MK1899: ≥103,0 i ≤105,8 FFU*
English: Lyophilisate: 10 vials, In cardboard box:
Croatian: Kartonska kutija s 10 bočica liofilizata i Kartonska kutija s 10 bočica otapala
English: Immediate packaging
Croatian: Pakovanje Sadržaj
English: Content
Croatian: EU broj
English: Withdrawal period
Croatian: Način primjene
English: The effect of each infusion lasts for a year or more.
Croatian: Djelovanje svake infuzije traje najmanje godinu dana ili više.
English: Gradually, the bones become thin and fragile, and more likely to fracture.
Croatian: Kosti postupno postaju tanke i lomljive, te je vjerojatnije da će se slomiti.
English: Other information about Aclasta:
Croatian: Ostale informacije o lijeku Aclasta:
English: Aclasta zoledronic acid
Croatian: Zoledronatna kiselina
English: What measures are being taken to ensure the safe and effective use of Aclasta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aclasta?
English: Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium.
Croatian: Bolesnici trebaju imati primjerene tekućine prije i nakon terapije, te trebaju dobivati odgovarajuće dodatke vitamina D i kalcija.
English: In these studies, the patients could take other medicines for osteoporosis, but not other bisphosphonates.
Croatian: U ovim ispitivanjima, bolesnici su mogli uzimati druge lijekove za osteoporozu, no ne i druge bifosfonate.
English: The European Commission granted a marketing authorisation valid throughout the EU for Aclasta on 15 April 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Aclasta na snazi u Europskoj uniji od 15. travnja 2005.
English: Aclasta is given as an infusion lasting at least 15 minutes.
Croatian: Aclasta se daje u obliku infuzije u venu koja traje najmanje 15 minuta.
English: This can be repeated once a year in patients being treated for osteoporosis.
Croatian: Postupak se može ponoviti jednom godišnje kod bolesnika koji se liječe od osteoporoze.
English: After six months, around 96% of patients had responded to treatment in the two studies, compared with around 74% of the patients who received risedronate.
Croatian: Nakon šest mjeseci, otprilike 96% bolesnika odgovorilo je na terapiju u dva ispitivanja, u usporedbi s otprilike 74% bolesnika koji su primili risedronat.
English: For Paget's disease, only one infusion of Aclasta is usually given, but additional infusions can be considered if the patient's disease comes back.
Croatian: U slučaju Pagetove bolesti primjenjuje se najčešće samo jedna infuzija lijeka Aclasta, no dodatne se infuzije mogu uzeti u razmatranje ako se bolest bolesnika vrati.
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 Aclasta.
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 Aclasta.
English: This document is a summary of the European Public Assessment Report (EPAR) for Aclasta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aclasta.
English: A risk management plan has been developed to ensure that Aclasta is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aclasta.
English: Because zoledronic acid has been authorised in the EU as Zometa for a number of years, the company presented the results of some studies carried out with Zometa, which were taken into account when assessing Aclasta.
Croatian: Budući da je zoledronatna kiselina odobrena u EU kao Zometa već niz godina, tvrtka je dostavila rezultate pojedinih ispitivanja provedenih s lijekom Zometa, koji su uzeti u obzir prilikom ocjenjivanja lijeka Aclasta.
English: The patients received one infusion of Aclasta or they took risedronate once a day for two months.
Croatian: Bolesnici su primili jednu infuziju lijeka Aclasta ili su uzimali risedronat jedno dnevno tijekom dva mjeseca.
English: Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion.
Croatian: Primjenom paracetamola ili ibuprofena (protuupalnih lijekova) ubrzo nakon lijeka Aclasta mogu se smanjiti simptomi poput vrućice, mišićne boli, simptoma sličnih influenci (gripi), boli u zglobovima i glavobolji unutar tri dana nakon infuzije.
English: The main measure of effectiveness was the number of patients who responded to treatment, defined as blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returning to normal or falling at least three-quarters of the way back to normal.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su odgovorili na terapiju, definirano kao vraćanje koncentracija serumnske alkalin fosfataze u krvi (enzima uključenog u razgradnju kosti) na normalne vrijednosti ili smanjenje na najmanje tri četvrtine prema normalnim vrijednostima.
English: The company that makes Aclasta will provide educational packs in each Member State for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used.
Croatian: Proizvođač lijeka Aclasta dostavit će edukacijske pakete u svakoj državi članici za liječnike koji propisuju lijek Aclasta za osteoporozu, podsjećajući ih na način primjene lijeka.
English: In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Croatian: U slučaju Pagetove bolesti, kosti brže pucaju, te nakon što ponovno izrastu, one su slabije nego što je to uobičajeno.
English: This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Croatian: Ovo rezultira manjim gubitkom kostiju u osteoporozi i smanjenom aktivnošću Pagetove bolesti.
English: For Paget's disease, Aclasta has been compared with risedronate in a total of 357 adults in two studies lasting six months.
Croatian: U slučaju Pagetove bolesti, Aclasta je uspoređen s risedronatom kod ukupno 357 odraslih osoba u dva ispitivanja koja su trajala šest mjeseci.
English: Patients will also be provided with a reminder card on the risk of osteonecrosis of the jaw, instructing patients to contact their doctor if they experience symptoms.
Croatian: Bolesnicima će se također dostaviti kartica s podsjetnikom o riziku osteonekroze čeljusti, koja daje uputu bolesnicima da kontaktiraju svoje liječnike ako iskuse simptome.
English: This is a disease where the normal process of bone growth is changed.
Croatian: U slučaju ove bolesti promijenjen je normalan postupak rasta kostiju.
English: Aclasta is also used to treat Paget's disease of the bone in adults.
Croatian: Aclasta se također koristi za liječenje Pagetove bolesti kostiju kod odraslih osoba.
English: Zoledronic acid has also been authorised in the European Union (EU) as Zometa since March 2001 for the prevention of bone complications in patients with cancer that is affecting the bone, and for the treatment of hypercalcaemia (high blood calcium levels) caused by tumours.
Croatian: Zoledronatna kiselina je također odobrena u Europskoj uniji (EU) kao lijek Zometa od ožujka 2001. godine za potrebe prevencije koštanih komplikacija u bolesnika s rakom koji zahvaća kost, kao i za terapiju hiperglikemije (visoke koncentracije kalcija u krvi) koju uzrokuju tumori.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Croatian: Osteoporoza nastupa kada nema dovoljnog rasta kostiju koje zamjenjuju kosti koje se razgrađuju prirodnim putem.
English: Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Croatian: Osteoporoza može također nastupiti kod oba spola kao nuspojava terapije glukokotikoidom.
English: What is the risk associated with Aclasta?
Croatian: Koji su rizici povezani s lijekom Aclasta?
English: It is used in patients who are at risk of fractures (broken bones) including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Croatian: Koristi se u bolesnika koji su izloženi riziku od fraktura (slomljenih kostiju) uključujući i one koji su nedavno slomili kuk pri manjim traumama poput pada, te kod bolesnika čija je osteoporoza povezana s dugoročnom terapijom glukokortikoidima (tipom steroida).
English: In the treatment of Paget's disease of the bone, Aclasta must only be used by a doctor who has experience in the treatment of the disease.
Croatian: U slučaju terapije Pagetove bolesti kostiju, lijek Aclasta smije primjenjivati samo liječnik koji je iskusan u terapiji bolesti.
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Croatian: U žena, osteoporoza je učestalija nakon menopauze, nakon što se razine ženskog hormona estrogena smanje.
English: Why has Aclasta been approved?
Croatian: Zašto je Aclasta odobrena?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aclasta, 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 Aclasta nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Patients who have broken their hip should not receive Aclasta any earlier than two weeks after the operation to repair the fracture.
Croatian: Bolesnici kojima je slomljen kuk ne smiju primati terapiju lijekom Aclasta unutar dva tjedna od operacije popravka frakture.
English: The full EPAR for Aclasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Aclasta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Aclasta pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite se svom liječniku ili ljekarniku.
English: Aclasta is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid.
Croatian: Aclasta je otopina za infuziju (drip) u venu koja sadrži djelatnu tvar zoledronatnu kiselinu.
English: In osteoporosis, Aclasta was more effective than the comparator medicines.
Croatian: U slučaju osteoporoze, Aclasta je bio djelotvorniji od komparatorskih lijekova.
English: Most side effects with Aclasta tend to occur within the first three days after infusion, becoming less common with repeated infusions.
Croatian: Najčešće nuspojave lijeka Aclasta nastupaju kako se čini unutra prva tri dana nakon infuzije, te su rjeđe pri svakom ponavljanju infuzija.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Croatian: Blokira aktivnost osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
English: What is Aclasta?
Croatian: Što je Aclasta?
English: Finally, Aclasta was more effective than risedronate at increasing spine bone density over a year's treatment in patients taking glucocorticoids.
Croatian: Naposljetku, Aclasta je bio djelotvorniji od risedronata u povećanju gustoće kosti kralježnice tijekom jednogodišnje terapije u bolesnika koji su uzimali glukokortikoide.
English: Aclasta is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Croatian: Aclasta se koristi za liječenje osteoporoze (bolesti koja kosti čini lomljivima) u žena u postmenopauzi i u muškaraca.
English: The CHMP decided that Aclasta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Aclasta nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The active substance in Aclasta, zoledronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Aclasta, zoledronatna kiselina je bisfosfonat.
English: In the study of elderly women, the risk of fractures in the spine was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years when compared with those taking placebo.
Croatian: U ispitivanju provedenom i starijih žena, rizik od fraktura kralježnice smanjen je za 70% u bolesnika koji su uzimali Aclasta (bez bilo kojih drugih lijekova za osteoporozu) tijekom razdoblja od tri godine kada je uspoređen s onima koji su uzimali placebo.
English: For osteoporosis, Aclasta has been studied in three main studies.
Croatian: U slučaju osteoporeze, lijeka Aclasta je ispitan u tri glavna ispitivanja.
English: Aclasta must not be used in people who are hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients.
Croatian: Aclasta se ne smije upotrebljavati kod osoba koje su preosjetljive (alergične) na bifosfonate ili na bilo koji drugi sastojak.
English: Aclasta must not be used in patients with severe kidney problems, hypocalcaemia (low blood calcium levels), or in pregnant or breastfeeding women.
Croatian: Aclasta se ne smije koristiti u bolesnika s ozbiljnim problemima u funkciji bubrega, hiperkalkemijom (malim koncentracijama kalcija u krvi), ili u trudnica ili dojilja.
English: In Paget's disease, Aclasta was more effective than risedronate.
Croatian: U slučaju Pagetove bolesti, Aclasta je bio djelotvorniji od risedronata.
English: In the study of men and women who had broken their hip, 9% of the patients receiving Aclasta had a fracture (92 out of 1,065), compared with
Croatian: U ispitivanju provedenom u muškaraca i žena koji su slomili kuk, 9% bolesnika koji su primali lijek Aclasta imalo je frakture (92 od 1.065), u usporedbi s 13% bolesnika koji su primali placebo (139 od 1.062).
English: The third compared one infusion of Aclasta with daily treatment with risedronate (another bisphosphonate) in 833 men and women with osteoporosis caused by glucocorticoids, and looked at the change in the density of the bones in the spine over a year.
Croatian: Treće je ispitivanje usporedilo jednu infuziju lijeka Aclasta s dnevnom terapijom risedronata (drugog bifosfonata) u 833 muškaraca i žena s osteoporozom uzrokovanom glukokortikoidima, te je istražilo promjene u gustoći kostiju kralježnice tijekom godina.
English: The second study compared Aclasta with placebo in 2,127 men and women with osteoporosis who had recently broken their hip, and looked at the number of fractures over up to five years.
Croatian: Drugo je ispitivanje usporedilo lijek Aclasta s placebom u 2.127 muškaraca i žena s osteoporozom, koji se nedavno slomili kuk, te je istražilo broj fraktura tijekom razdoblja od pet godina.
English: It will also provide an information pack for patients to explain the medicine's side effects, remind them of the need for adequate calcium and vitamin D supplementation, and when patients should contact their doctor.
Croatian: Proizvođač će također dostaviti informacijski paket za bolesnike, u kojem im objašnjava nuspojave lijeka, podsjećajući ih na potrebu primjerenog nadomjeska kalcija i vitamina D, te potrebi da se kontaktira liječnik.
English: Aclasta should not be used in patients with severe kidney problems.
Croatian: Aclasta se ne smije primjenjivati u bolesnika s ozbiljnim problemima u funkciji bubrega.
English: What benefit has Aclasta shown during the studies?
Croatian: Koje su koristi lijeka Aclasta utvrđene u ispitivanjima?
English: The first compared Aclasta with placebo (a dummy treatment) in almost 8,000 elderly women with osteoporosis, looking at the number of fractures in the spine and the hip over three years.
Croatian: Tvrtka je usporedila lijek Aclasta s placebom (lažnim liječenjem) u gotovo 8.000 starijih žena s osteoporozom, uzimajući u obzir broj fraktura kralježnice i kuka tijekom razdoblja od tri godine.
English: What is Aclasta used for?
Croatian: Za što se Aclasta koristi?
English: Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported rarely (seen in between 1 and 10 patients in 10,000).
Croatian: Rijetko je prijavljena (kod između 1 i 10 bolesnika na 10.000) osteonekroza čeljusti (oštećenje kosti čeljusti, koje može rezultirati s boli, bolnim ustima ili gubljenjem zubi).
English: How does Aclasta work?
Croatian: Kako djeluje Aclasta?
English: The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever.
Croatian: Vrućica je najčešća nuspojava lijeka Aclasta (kod više od 1 na 10 osoba).
English: How has Aclasta been studied?
Croatian: Kako je Aclasta ispitivana?
English: How is Aclasta used?
Croatian: Kako se Aclasta koristi?
English: There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo.
Croatian: prilikom usporedbe svih žena koje su uzimale lijek Aclasta (s ili bez drugih lijekova protiv osteoporoze) s onima koje su uzimale placebo.
English: For the full list of all side effects reported with Aclasta, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Aclasta potražite u uputi o lijeku.
English: Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja
English: Packaging
Croatian: Jačina
English: Solution: 5 ml (30 mg/ml) + Flushing solution 5ml
Croatian: Otopina: 5 ml (30 mg/ml) + otopina za ispiranje 5 ml
English: 2 vials + 1 vial
Croatian: 2 bočice + 1 bočica
English: Intracerebroventr icular use vial (glass)
Croatian: 150 mg Otopina za infuziju Intracerebroventr ikularna primjena bočica (staklo)
English: damage.
Croatian: oštećenja.
English: Side effects reported in children are similar to those seen in adults.
Croatian: Nuspojave prijavljene u djece slične su onima u odraslih osoba.
English: This can result in serious vision loss and even blindness.
Croatian: Ovo može rezultirati ozbiljnim gubitkom vida, pa čak i sljepoćom.
English: By lowering the pressure, Travatan reduces the risk of
Croatian: Snižavanjem tlaka, Travatan smanjuje rizik od
English: If other eye drops are also being used, they should be given at least 5 minutes apart.
Croatian: Ako se koriste i druge kapi za oko, lijekovi se moraju primijeniti s najmanje 5 minuta razmaka.
English: This helps to reduce the pressure inside the eye.
Croatian: Ovo pomaže pri smanjivanju tlaka unutar oka.
English: This summary was last updated in 12-2014.
Croatian: Sažetak je posljednji put ažuriran u 12.2014
English: There may also be changes to the patient's eyelashes, including increased length, thickness, colour or number of lashes.
Croatian: Promjene mogu nastupiti i u trepavicama bolesnika, uključujući povećanje dužine, debljinu, boju i broj trepavica.
English: The full EPAR for Travatan 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 Travatan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Travatan on 27 November 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Travatan vrijedi na prostoru Europske unije od 27. studenog 2001.
English: Travatan has been studied in 1,989 adult patients in three main studies, lasting between six and 12 months.
Croatian: Travatan je ispitan u 1.989 odraslih bolesnika u tri glavna ispitivanja, koja su trajala između šest i 12 mjeseci.
English: The main measure of effectiveness in all studies was the reduction in intraocular pressure
Croatian: Glavna mjera ispitivanja djelotvornosti u svim ispitivanjima bilo je smanjenje u intraokularnom tlaku.
English: A fourth study also compared the effectiveness of adding Travatan to treatment with timolol (427 patients, six-month duration).
Croatian: Četvrto ispitivanje usporedilo je djelotvornost dodavanja lijeka Travatan u terapiju timololom (427 bolesnika, trajanje šest mjeseci).
English: In addition, Travatan was compared with timolol in a fifth main study over 3 months, involving 152 children between 2 months and 18 years of age.
Croatian: Nadalje, Travatan je uspoređen s timololom u petom glavnom ispitivanju koje je trajalo tri mjeseca, a obuhvatilo je 152 djece u dobi između 2 mjeseca i 18 godina.
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 Travatan.
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 preporuke o uvjetima korištenja za lijek Travatan.
English: Travatan was at least as effective as timolol and as effective as latanoprost in reducing intraocular pressure.
Croatian: Travatan je bio barem podjednako učinkovit kao timolol i podjednako učinkovit kao latanoprost u snižavanju intraokularnog tlaka.
English: It can also be used in children from two months of age who have ocular hypertension or childhood glaucoma.
Croatian: Može se također koristiti u djece u dobi od dva mjeseca i starije, koja pate od okularne hipertenzije ili dječjeg glaukoma.