FrancophonIA/ELRC3.0 huggingface dataset:
English: Stocrin is an antiviral medicine that is used together with other antiviral medicines to treat patients aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lijek Stocrin antivirusni je lijek koji se primjenjuje u kombinaciji s drugim antivirusnim lijekovima za liječenje bolesnika u dobi od tri godine i starijih koji su zaraženi virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: • in the first study, Stocrin in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine.
Croatian: • u prvom ispitivanju, primjena lijeka Stocrin u kombinaciji s lamivudinom i zidovudinom ili s indinavirom (drugi antivirusni lijekovi) uspoređena je s kombinacijom indinavira, lamivudina i zidovudina.
English: Stocrin can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Croatian: Lijek Stocrin izdaje se samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: For more information about treatment with Stocrin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Stocrin pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: What benefits of Stocrin have been shown in studies?
Croatian: Koje su koristi od lijeka Stocrin utvrđene u ispitivanjima?
English: 67% of the adults treated with Stocrin in combination with zidovudine and lamivudine had viral loads below 400 copies/ml after 48 weeks, compared with 54% of the patients treated with Stocrin and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;
Croatian: Nakon 48 tjedana liječenja, virusno opterećenje manje od 400 kopija/ml imalo je 67 % odraslih osoba liječenih lijekom Stocrin u kombinaciji sa zidovudinom i lamivudinom, u usporedbi s 54 % bolesnika liječenih lijekom Stocrin i indinavirom, te s 45 % bolesnika liječenih indinavirom, lamivudinom i zidovudinom;
English: The Agency noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Croatian: Agencija je uočila da liječenje lijekom Stocrin nije odgovarajuće ispitano u bolesnika s uznapredovalom bolešću (broj CD4 stanica manji od 50 stanica/mm3) ni nakon neuspješnog liječenja inhibitorima proteaze (druga vrsta antivirusnog lijeka).
English: For practical information about using Stocrin, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Stocrin bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: How is Stocrin used?
Croatian: Kako se Stocrin koristi?
English: • the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
Croatian: • u trećem ispitivanju uspoređeno je dodavanje lijeka Stocrin ili placeba (prividno liječenje) kombinaciji antivirusnih lijekova koja je uključivala indinavir i druga dva antivirusna lijeka u bolesnika koji su već primali terapiju za infekciju HIV-om.
English: How does Stocrin work?
Croatian: Kako djeluje Stocrin?
English: The Stocrin combination was more effective than the combination without Stocrin: 70% and 30% of the patients, respectively, had viral loads below 500 copies/ml after 48 weeks;
Croatian: Kombinacija s lijekom Stocrin bila je djelotvornija od kombinacije bez lijeka Stocrin: nakon 48 tjedana liječenja virusno opterećenje manje od 500 kopija/ml imalo je 70 %, odnosno 30 % bolesnika;
English: • the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin.
Croatian: • u drugom ispitivanju uspoređena je primjena lijeka Stocrin u kombinaciji s nelfinavirom i drugim dvama antivirusnim lijekovima s istom kombinacijom bez lijeka Stocrin.
English: Similar results were seen in a study in 57 children aged between 3 and 16 years, given Stocrin in combination with nelfinavir and other antiviral medicines.
Croatian: Slični rezultati zabilježeni su u ispitivanju primjene lijeka Stocrin u kombinaciji s nelfinavirom i drugim antivirusnim lijekovima u 57 djece u dobi od tri do 16 godina.
English: For the full list of side effects reported with Stocrin, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih prilikom primjene lijeka Stocrin potražite u uputi o lijeku.
English: More patients receiving Stocrin had viral loads below 400 copies/ml than those taking placebo after 24 weeks
Croatian: Nakon 24 tjedna liječenja virusno opterećenje manje od 400 kopija/ml zabilježeno je u više bolesnika koji su primali lijek Stocrin u odnosu na bolesnike koji su primali placebo.
English: Stocrin has shown benefit in controlling HIV infection in three main studies involving over 1,100 adults.
Croatian: U trima glavnim ispitivanjima koja su obuhvatila više od 1 100 odraslih osoba, dokazana je korist od lijeka Stocrin u kontroli infekcije virusom HIV-a.
English: To investigate this further the Agency recommended that a study be carried out.
Croatian: Kako bi se ovo dalje istražilo, Agencija je preporučila provođenje ispitivanja.
English: Previously known as Laventair.
Croatian: Prethodno poznat kao Laventair.
English: Further information on Laventair Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Laventair Ellipta možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In all 4 studies, involving over 4,700 patients, the main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Croatian: U sva četiri ispitivanja, koja su obuhvatila više od 4 700 bolesnika, glavno mjerilo učinkovitosti lijeka temeljilo se na promjenama forsiranog izdisajnog volumena bolesnika (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u sekundi).
English: When inhaled, vilanterol reaches the receptors in the airways and activates them.
Croatian: Prilikom inhalacije vilanterol doseže receptore u zračnim putevima i aktivira ih.
English: For detailed information on using the inhaler correctly, see the instructions in the package leaflet or contact your doctor and pharmacist.
Croatian: Detaljne informacije o ispravnoj upotrebi inhalatora pronađite u uputi o lijeku ili se obratite vašem liječniku ili ljekarniku.
English: The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Croatian: Kombinirano djelovanje dviju djelatnih tvari pomaže održati dišne putove otvorenima i omogućava bolesniku lakše disanje.
English: It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles.
Croatian: Djeluje blokirajući druge receptore zvane muskarinski receptori koji kontroliraju kontrakciju mišića.
English: It works by attaching to beta-2 receptors found in the muscle cells of many organs including the airways in the lungs.
Croatian: Djeluje tako što se veže na beta-2 receptore koji se nalaze u mišićnim stanicama mnogih organa, uključujući zračne puteve u plućima.
English: The most common side effects with Laventair Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.
Croatian: Najčešće nuspojave lijeka Laventair Ellipta (koje se mogu javiti u 1 od 10 osoba) su infekcije gornjeg dišnog sustava (infekcija nosa i grla), infekcije mokraćnog sustava (infekcija struktura koje prenose mokraću), faringitis (upala grla), sinusitis (upala sinusa), nazofaringitis (upala nosa i grla), glavobolja, kašalj, orofaringealna bol (bol u ustima i grlu), zatvor i suha usta.
English: As medicines of the same class as Laventair Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Croatian: Budući da lijekovi istog razreda kao Laventair Ellipta mogu imati učinak na srce i krvne žile u mozgu, tvrtka koja lijek Laventair Ellipta stavlja na tržište provest će dugoročno ispitivanje na bolesnicima radi prikupljanja daljnjih podataka o njegovoj sigurnosti u usporedbi s tiotropijem.
English: Laventair Ellipta contains two active substances.
Croatian: Laventair Ellipta sadrži dvije aktivne tvari.
English: This relaxes the muscles of the airways.
Croatian: To uzrokuje opuštanje mišića zračnih puteva.
English: Recommendations and precautions to be followed by healthcare professionals and patients have also 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 nalaze se i u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Laventair Ellipta1 (umeclidinium bromide / vilanterol)
Croatian: Laventair Ellipta1 (umeklidinijev bromid / vilanterol)
English: Each inhalation provides 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidinium) and 22 micrograms of vilanterol.
Croatian: Svaka inhalacija pruža 65 mikrograma umeklidinijeva bromida (što odgovara dozi od 55 mikrograma umeklidinija) i 22 mikrograma vilanterola.
English: Side effects reported with Laventair Ellipta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Laventair Ellipta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The results for the higher dose combination of umeclidinium bromide and vilanterol did not consistently show relevant improvements in lung function to justify its use.
Croatian: Kombinacija jače doze umeklidinijeva bromida i vilanterola nije konzistentno rezultirala značajnim poboljšanjima u funkciji pluća kako bi se opravdala njezina uporaba.
English: The Agency also noted that there were no major safety concerns with Laventair Ellipta, with side effects being manageable, although the longterm safety data so far are limited.
Croatian: Agencija je također zaključila da nisu ustanovljeni razlozi za ozbiljnu zabrinutost u pogledu sigurnosti lijeka Laventair Ellipta, budući da se nuspojavama može upravljati, iako su dugoročni podatci o sigurnoj primjeni zasad ograničeni.
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Croatian: Kombinacija antagonista muskarinskih receptora i dugodjelujućih beta-2 agonista uobičajena je u upravljanju KOPD-om.
English: Laventair Ellipta received a marketing authorisation valid throughout the EU on 8 May 2014.
Croatian: Lijek Laventair Ellipta dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 8. svibnja 2014.
English: What measures are being taken to ensure the safe and effective use of Laventair Ellipta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Laventair Ellipta?
English: As for all medicines, data on the use of Laventair Ellipta are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Laventair Ellipta kontinuirano se prate.
English: Laventair Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Laventair Ellipta je lijek koji se primjenjuje za ublažavanje simptoma kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: Other information about Laventair Ellipta
Croatian: Ostale informacije o lijeku Laventair Ellipta
English: What is Laventair Ellipta and what is it used for?
Croatian: Što je Laventair Ellipta i za što se primjenjuje?
English: The European Medicines Agency decided that Laventair Ellipta's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Laventair Ellipta nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The Agency concluded that Laventair Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Croatian: Agencija je zaključila da se lijek Laventair Ellipta pokazao djelotvornim u poboljšavanju funkcije pluća i ublažavanju simptoma KOPD-a u usporedbi s placebom ili jednom od komponenti kao i s tiotropijem.
English: Laventair Ellipta contains the active substances umeclidinium bromide and vilanterol.
Croatian: Laventair Ellipta sadrži djelatne tvari umeklidinijev bromid i vilanterol.
English: Laventair Ellipta also increased FEV1 by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone.
Croatian: Laventair Ellipta je također povećao FEV1 prosječno za 95 ml više u odnosu na samo vilanterol te za 52 ml više u odnosu na samo umeklidinijev bromid.
English: Laventair Ellipta is used for maintenance (regular) treatment.
Croatian: Laventair Ellipta primjenjuje se kao (redovita) terapija održavanja.
English: The average increase in FEV1 with Laventair Ellipta was 90 ml more than with tiotropium after 24 weeks of treatment.
Croatian: Prosječno povećanje u FEV1 s lijekom Laventair Ellipta bilo je 90 ml više u odnosi na tiotropij nakon 24 tjedna liječenja.
English: Results showed that Laventair Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Croatian: Rezultati su pokazali da je lijek Laventair Ellipta poboljšao funkciju pluća za prosječnu vrijednost FEV1 za 167 ml više u odnosu na placebo nakon 24 tjedna liječenja.
English: An overview of Laventair Ellipta and why it is authorised for use in the EU
Croatian: Pregled informacija o lijeku Laventair Ellipta i zašto je odobren u EU-u
English: Why is Laventair Ellipta authorised in the EU?
Croatian: Zašto je lijek Laventair Ellipta odobren u EU-u?
English: What are the risks associated with Laventair Ellipta?
Croatian: Koji su rizici povezani s lijekom Laventair Ellipta?
English: Laventair Ellipta can only be obtained with a prescription.
Croatian: Lijek Laventair Ellipta izdaje se samo na liječnički recept.
English: Laventair Ellipta was also shown to improve symptoms such as breathlessness and wheezing.
Croatian: Lijek Laventair Ellipta također je pokazao ublažavanje simptoma poput nedostatka zraka i piskanja pri disanju.
English: Laventair Ellipta and a higher-dose combination of umeclidinium bromide and vilanterol were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium bromide alone and another COPD medicine called tiotropium in 4 main studies.
Croatian: U četirima glavnim ispitivanjima lijek Laventair Ellipta i kombinacija veće doze umeklidinija i vilanterola uspoređivani su s placebom (prividno liječenje), samo s vilanterolom, samo s umeklidinijevim bromidom i lijekom protiv KOPD-a pod nazivom tiotropij.
English: What benefits of Laventair Ellipta have been shown in studies?
Croatian: Koje su koristi od lijeka Laventair Ellipta utvrđene u ispitivanjima?
English: How does Laventair Ellipta work?
Croatian: Kako djeluje Laventair Ellipta?
English: How is Laventair Ellipta used?
Croatian: Kako se Laventair Ellipta primjenjuje?
English: < PC: {number} SN: {number} NN: {number} >
Croatian: < PC: {broj} SN: {broj} NN: {broj}>
English: 20014 Nerviano (MI) Italy
Croatian: 20014 Nerviano (MI) Italija
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09 Desember 2016
Croatian: Datum posljednje obnove odobrenja: 09 prosinca 2016
English: Pack sizes: 1, 4 or 10 vials.
Croatian: Veličine pakiranja: 1, 4 ili 10 bočica.
English: <2D barcode carrying the unique identifier included.> <Not applicable.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.> <Nije primjenjivo.>
English: - Confusion.
Croatian: - Zbunjenost.
English: - if you have or have had a kidney problem.
Croatian: - ako imate ili ste imali tegobe s bubrezima.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Croatian: - Zamagljen vid, suzenje oka, osjetljivost očiju na svjetlost.
English: Women of childbearing potential should be advised to avoid becoming pregnant.
Croatian: Ženama reproduktivne dobi potrebno je savjetovati da izbjegavaju trudnoću.
English: - Low counts of white blood cells and blood platelets.
Croatian: Nizak broj bijelih krvnih stanica i krvnih pločica.
English: Zoledronic acid Actavis can be given to people aged 65 years and over.
Croatian: Zoledronatna kiselina Actavis može se davati osobama u dobi od 65 ili više godina.
English: Tell your doctor about any of the following side effects as soon as possible:
Croatian: Obavijestite svog liječnika čim prije o svakoj od sljedećih nuspojava:
English: - Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: Razgovarajte sa svojim liječnikom ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja do primjene odgovornost su korisnika i normalno ne smiju biti duži od 24 sata pri 2°C do 8°C.
English: Zoledronic acid Actavis is supplied as packs containing 1, 4 or 10 vials.
Croatian: Zoledronatna kiselina Actavis isporučuje se u pakiranjima koja sadrže 1, 4 ili 10 bočica.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Croatian: Mogući čimbenici rizika za osteonekrozu vanjskog slušnog kanala uključuju primjenu steroida i kemoterapije i/ili lokalne čimbenike rizika poput infekcije ili traume.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Actavis properly.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra znaju kako ispravno čuvati Zoledronatnu kiselinu Actavis.
English: • To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Croatian: • Smanjenje količine kalcija u krvi u odraslih bolesnika kad je količina kalcija prevelika zbog prisutnosti tumora.
English: EU/1/12/759/001 1vial EU/1/12/759/002 4 vials EU/1/12/759/003 10 vials
Croatian: EU/1/12/759/001 1 bočica EU/1/12/759/002 4 bočice EU/1/12/759/003 10 bočica
English: Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Croatian: Produljenje trajanja infuzije sa 5 na 15 minuta prouzročilo je 30%-tno sniženje koncentracije zoledronatne kiseline na kraju infuzije, ali nije imalo nikakvog učinka na površinu ispod krivulje koncentracije u plazmi u vremenu mjerenja.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA08
English: Additional information on handling of Zoledronic acid Actavis, including guidance on preparation of reduced doses, is provided in section 4.2.
Croatian: Dodatne informacije o rukovanju Zoledronatnom kiselinom Actavis, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2.
English: - Painful redness and/or swelling of the eye.
Croatian: - Bolno crvenilo i/ili oticanje oka.
English: - A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Croatian: Poremećaj rada bubrega koji se zove Fanconijev sindrom (kojeg inače može odrediti Vaš liječnik pomoću određenih testova urina).
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Croatian: Hipokalcemija je važan identificiran rizik kod zoledronatne kiseline u odobrenim indikacijama.
English: Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.
Croatian: Ne preporučuje se primjena Zoledronatne kiseline Actavis u adolescenata i djece mlađe od 18 godina.
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid Actavis via the domestic sewage system.
Croatian: Zdravstvenim radnicima se savjetuje da ne uklanjaju neiskorištenu Zoledronatnu kiselinu Actavis putem kanalizacije.
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Actavis and inform your doctor about your dental treatment.
Croatian: - ako se liječite kod zubara ili trebate ići na zubarski kirurški zahvat, obavijestite svog zubara da se liječite Zoledronatnom kiselinom Actavis i obavijestite svog liječnika o Vašem liječenju kod zubara
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Croatian: Osobito je važno da obavijestite liječnika ako također uzimate: - Aminoglikozide (lijekovi za liječenje teških infekcija), kalcitonin (vrsta lijeka za liječenje post menopauzalne osteoporoze i hiperkalcemije), diuretici Henleove petlje (vrsta lijekova za liječenje visokog krvnog tlaka ili edema) ili drugi lijekovi koji snizuju razinu kalcija, budući da kombinacija ovih lijekova s bisfosfonatima može dovesti do preniskih razina kalcija u krvi.
English: - Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Croatian: - Istodobnu terapiju , kemoterapiju , inhibitore angiogeneze (vidjeti dio 4.5), radioterapiju vrata i glave, kortikosteroide.
English: Very common (may affect more than 1 in 10 people): - Low level of phosphate in the blood.
Croatian: Vrlo često (može se javiti u više od 1 na 10 osoba): - Niska razina fosfata u krvi.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Croatian: Ukupni klirens iz tijela iznosi 5,04 ± 2,5 l/h, ne ovisi o dozi i na njega ne utječu spol, dob,
English: - Keep Zoledronic acid Actavis out of the sight and reach of children.
Croatian: - Zoledronatnu kiselinu Actavis čuvati izvan pogleda i dohvata djece.
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Croatian: Mogućnost osteonekroze vanjskog slušnog kanala treba uzeti u obzir kod bolesnika koji primaju bisfosfonate, a imaju simptome poremećaja uha uključujući kronične infekcije uha.