FrancophonIA/ELRC3.0 huggingface dataset:
English: Rasilez HCT 150 mg/25 mg film-coated tablets
Croatian: Rasilez HCT 150 mg/25 mg filmom obložene tablete
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu kroz usta.
English: Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet u rizičnih bolesnika koji su primali aliskiren prijavljeno je akutno zatajenje bubrega, reverzibilno nakon prekida liječenja.
English: Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat starch.
Croatian: Pomoćne tvari s poznatim učinkom: Jedna tableta sadrži 50 mg laktoze (u obliku hidrata) i 49 mg pšeničnog škroba.
English: The other ingredients are: Microcrystalline cellulose, crospovidone type A, lactose monohydrate (see section 2), wheat starch (see section 2), povidone K-30, magnesium stearate, silica colloidal anhydrous, talc, hypromellose substitution type 2910 (3 mPa s), macrogol 400, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).
Croatian: Drugi sastojci su: mikrokristalična celuloza, krospovidon vrste A, laktoza hidrat (vidjeti dio 2), pšenični škrob (vidjeti dio 2), povidon K-30, magnezijev stearat, koloidni, bezvodni silicijev dioksid, talk, hipromeloza supstitucijske vrste 2910 (3 mPa·s), makrogol 400, titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172).
English: • Low level of sodium in the blood
Croatian: • niska razina natrija u krvi
English: (medicines used to treat chest or urinary infections) or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Rasilez HCT: - ako ste alergični na aliskiren ili hidroklorotiazid, lijekove dobivene iz sulfonamida (lijekovi koji se koriste za liječenje infekcija u prsnom košu ili mokraćnim putevima) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING PA/ALU/PVC BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KOJA SADRŽI PA/AL/PVC BLISTERE
English: Digoxin and verapamil bioavailability may be slightly decreased by aliskiren.
Croatian: Aliskiren može blago smanjiti bioraspoloživost digoksina i verapamila.
English: Rasilez HCT 150 mg/25 mg film-coated tablets are pale yellow, oval film-coated tablets imprinted with “CLL” on one side and “NVR” on the other.
Croatian: Rasilez HCT 150 mg/25 mg filmom obložene tablete su blijedo žute, ovalne filmom obložene tablete, s utisnutom oznakom „CLL“ na jednoj i „NVR“ na drugoj strani.
English: Rasilez HCT 150 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 25 mg alone or by Rasilez HCT 150 mg/12.5 mg.
Croatian: Rasilez HCT 150 mg/25 mg se može primijeniti u bolesnika u kojih krvni tlak nije odgovarajuće kontroliran primjenom samo 150 mg aliskirena ili samo 25 mg hidroklorotiazida ili s Rasilez HCT 150 mg/12,5 mg.
English: Rasilez HCT 300 mg/25 mg film-coated tablets - Each tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Croatian: Rasilez HCT 300 mg/25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 30o mg aliskirena (u obliku aliskirenhemifumarata) i 25 mg hidroklorotiazida.
English: Thiazide diuretics may precipitate azotaemia in patients with chronic kidney disease.
Croatian: Oštećenje bubrežne funkcije i transplantacija bubrega Tiazidni diuretici mogu izazvati azotemiju u bolesnika s kroničnom bolešću bubrega.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Croatian: Jedna filmom obložena tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata) i 25 mg hidroklorotiazida.
English: - hereditary angioedema.
Croatian: Aplastična anemijah
English: Rasilez HCT 300 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 12.5 mg alone or by Rasilez HCT 150 mg/12.5 mg.
Croatian: Rasilez HCT 300 mg/12,5 mg se može primijeniti u bolesnika u kojih krvni tlak nije odgovarajuće kontroliran primjenom samo 300 mg aliskirena ili samo 12,5 mg hidroklorotiazida ili s Rasilez HCT 150 mg/12,5 mg.
English: Rasilez HCT 300 mg/12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with “CVI” on one side and “NVR” on the other.
Croatian: Rasilez HCT 300 mg/12,5 mg filmom obložene tablete su ljubičasto-bijele, ovalne filmom obložene tablete, s utisnutom oznakom „CVI“ na jednoj i „NVR“ na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/25 mg film-coated tablets aliskiren/hydrochlorothiazide
Croatian: Rasilez HCT 150 mg/25 mg filmom obložene tablete aliskiren/hidroklorotiazid
English: Arthralgia has been reported in post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet prijavljena je artralgija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKIH PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR) KOJA SADRŽI PA/AL/PVC BLISTERE
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets White, biconvex, ovaloid film-coated tablet imprinted with “LCI” on one side and “NVR” on the other.
Croatian: Rasilez HCT 150 mg/12,5 mg filmom obložene tablete Bijela, bikonveksna, ovalna filmom obložena tableta, s utisnutom oznakom „LCI“ na jednoj i „NVR“ na drugoj strani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKIH PAKIRANJA (BEZ PLAVOG OKVIRA) KOJA SADRŽI PA/AL/PVC BLISTERE
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Croatian: Rasilez HCT 300 mg/25 mg filmom obložene tablete aliskiren/hidroklorotiazid
English: Cardiac disorders Common
Croatian: Srčane aritmijeh
English: - medicines to reduce blood pressure, including methyldopa, an angiotensin II receptor blocker or an angiotensin converting enzyme inhibitor (see sections “Do not take Rasilez HCT” and “Warnings and precautions”).
Croatian: antiepileptici (karbamazepin). - lijekovi protiv bolova kao što su nesteroidni protuupalni lijekovi (NSAIL), uključujući selektivne inhibitore ciklooksigenaze-2 (COX-2 inhibitore). - lijekove za snižavanje krvnog tlaka, uključujući metildopu, blokator angiotenzin II receptora ili inhibitor angiotenzin - konvertirajućeg enzima, (vidjeti također dijelove„Nemojte uzimati
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/12.5 mg film-coated tablets aliskiren/hydrochlorothiazide
Croatian: Rasilez HCT 150 mg/12,5 mg filmom obložene tablete aliskiren/hidroklorotiazid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 150 mg aliskirena (u obliku aliskirenhemifumarata) i 25 mg hidroklorotiazida.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 150 mg aliskirena (u obliku aliskirenhemifumarata) i 12,5 mg hidroklorotiazida.
English: Dyspnoeaa
Croatian: Dispnejaa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata) i 12,5 mg hidroklorotiazida.
English: NAME OF THE MEDICINAL PRODUCT Rasilez HCT 300 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Croatian: Rasilez HCT 300 mg/12,5 mg filmom obložene tablete aliskiren/hidroklorotiazid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/061
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/061
English: Rasilez HCT 300 mg/25 mg film-coated tablets are light yellow, oval film-coated tablets imprinted with “CVV” on one side and “NVR” on the other.
Croatian: Rasilez HCT 300 mg/25 mg filmom obložene tablete su svijetložute, ovalne filmom obložene tablete, s utisnutom oznakom „CVV“ na jednoj i „NVR“ na drugoj strani.
English: P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Croatian: Kontraindicirana je istodobna primjena aliskirena s ciklosporinom i itrakonazolom, dva visoko potentna inhibitora P-glikoproteina (P-gp), i drugim potentnim P-gp inhibitorima (npr. kinidin)
English: • Low level of potassium in the blood
Croatian: • niska razina kalija u krvi
English: No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment (see sections 4.3, 4.4 and 5.2).
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije jetre nije potrebna prilagodba početne doze (vidjeti dijelove 4.3, 4.4 i 5.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/039
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/039
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/059
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/059
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata) i 25 mg hidroklorotiazida.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/029
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/068
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/068
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Croatian: - Jedna tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata) i 12,5 mg hidroklorotiazida.
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Croatian: - Jedna tableta sadrži 150 mg aliskirena (u obliku aliskirenhemifumarata) i 25 mg hidroklorotiazida.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/079
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/079
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/069
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/069
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/070
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/070
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/049
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/049
English: Posology in patients not adequately controlled with aliskiren or hydrochlorothiazide monotherapy Individual dose titration with each of the two components may be recommended before changing to the fixed combination.
Croatian: Prije prelaska na fiksnu kombinaciju može se preporučiti individualno titriranje doze svake komponente.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/021
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/021
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/041
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/041
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/028
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/028
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/050
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/050
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/009
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets.
Croatian: 14 filmom obloženih tableta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/030
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/030
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/020
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/020
English: Rasilez HCT should be discontinued if hypercalcaemia develops during treatment.
Croatian: Ako se tijekom liječenja Rasilez HCT-om razvije hiperkalcijemija primjena lijeka se mora prekinuti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/048
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/048
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.2 and 4.4).
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije bubrega nije potrebna prilagodba početne doze (vidjeti dijelove 4.2 i 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/060
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/060
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/019
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/019
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/040
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/040
English: Haemoglobin and haematocrit
Croatian: Hemoglobin i hematokrit
English: What Rasilez HCT looks like and contents of the pack Rasilez HCT 150 mg/12.5 mg film-coated tablets are white, oval film-coated tablets imprinted with “LCI” on one side and “NVR” on the other.
Croatian: Rasilez HCT 150 mg/12,5 mg filmom obložene tablete su bijele, ovalne filmom obložene tablete, s utisnutom oznakom „LCI“ na jednoj i „NVR“ na drugoj strani.
English: Titanium dioxide (E171) Red iron oxide (E172)
Croatian: Ovojnica: talk hipromeloza, supstitucija tipa 2910 (3 mPa·s) makrogol 4000 titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/491/080
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/491/080
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe with needle guard + 1 alcohol swab pre-filled injector (glass) 0.6 ml (10 mg/ml) 1 pre-filled injector + 1 alcohol swab
Croatian: 0,6 ml (10 mg/ml) 1 napunjena štrcaljka sa štitnikom za iglu + 1 alkoholni jastučić napunjeni injektor (staklo)
English: Pack size pre-filled syringe (glass) with needle guard
Croatian: Veličina pakiranja napunjena štrcaljka (staklo) sa štitnikom za iglu
English: The review was initiated at the request of the European Commission on 7 May 2015, under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje je započelo 7. svibnja 2015. na zahtjev Europske komisije, u skladu s člankom 31. Direktive 2001/83/EZ.
English: • Patients who have any concerns should discuss them with their doctor or other healthcare professional.
Croatian: • Bolesnici koji imaju bilo kakve nedoumice moraju o njima razgovarati sa svojim liječnikom ili nekim drugim zdravstvenim djelatnikom.
English: Commission Decision dates: 29/06/2016 (nationally authorised products), 24/06/2016 (Relvar Ellipta, Revinty Ellipta), 04/07/2016 (BiResp Spiromax, DuoResp Spiromax), 06/07/2016 (Budesonide/Formoterol Teva, Vylaer Spiromax).
Croatian: Datumi odluke Komisije: 29. 6. 2016. (nacionalno odobreni proizvodi), 24. 6. 2016. (Relvar Ellipta, Revinty Ellipta), 4. 7. 2016. (BiResp Spiromax, DuoResp Spiromax), 6. 7. 2016. (Budesonide/Formoterol Teva, Vylaer Spiromax).
English: Corticosteroid-containing medicines have been authorised in the EU through both central and national approval procedures.
Croatian: Lijekovi koji sadrže kortikosteroide odobreni su u EU-u putem centralnih i nacionalnih postupaka izdavanja odobrenja.
English: They are similar to natural hormones normally produced by the adrenal glands (two small glands located above the kidneys).
Croatian: Slični su prirodnim hormonima koje obično proizvode nadbubrežne žlijezde (dvije male žlijezde koje se nalaze iznad bubrega).
English: They should not stop using their inhaler or change the way they use it without consulting their prescriber.
Croatian: Ne smiju prestati upotrebljavati svoj inhalator ili mijenjati način na koji ga upotrebljavaju, a da se prethodno ne posavjetuju s liječnikom koji im je izdao recept za liječenje.
English: • The product information for all medicines of the class will be updated to reflect current knowledge about pneumonia risk.
Croatian: • Ažurirat će se informacije o proizvodu za sve lijekove tog razreda kako bi odražavale postojeća saznanja o riziku od upale pluća.
English: Due to the variability in the clinical data and multiple uncertainties with study methodologies, this does not provide conclusive evidence for intra-class differences in the magnitude of risk.
Croatian: Zbog varijabilnosti u kliničkim podacima i mnogim nesigurnostima u pogledu metodologija ispitivanja ne postoje uvjerljivi klinički dokazi koji bi upućivali na razlike u okviru razreda u pogledu razmjera rizika.
English: They are usually taken using inhalers which either contain a corticosteroid alone or a corticosteroid in combination with another medicine (such as a long-acting beta2 agonist that widens the airways).
Croatian: Obično se uzimaju putem inhalatora koji sadrže samo kortikosteroid ili kortikosteroid u kombinaciji s nekim drugim lijekom (kao što je beta2-adrenergički agonist dugotrajnog djelovanja koji proširuje dišne putove).
English: • Patients should be advised to report any increased breathing difficulties or other symptoms suggestive of infection.
Croatian: • Bolesnike je potrebno savjetovati da prijave bilo kakvo pogoršanje teškoća pri disanju ili druge simptome koji upućuju na infekciju.
English: • There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Croatian: • Postoje određeni dokazi o većem riziku od upale pluća u slučaju povećanja doze steroida, no to nije uvjerljivo dokazano u svim ispitivanjima.
English: These symptoms can be like those of an exacerbation (an episode of worsening COPD) and include fever or chills, increased amounts of mucus (phlegm) or a change in its colour, or worsening of cough or breathing difficulties.
Croatian: Ti simptomi mogu biti slični simptomima egzacerbacije (epizode pogoršanja KOPB-a) i uključivati vrućicu ili zimicu, povećane količine mukusa (sluzi) ili promjenu njegove boje ili intenzivnije kašljanje ili pogoršanje teškoća pri disanju.
English: In the EU, the available products include the active substances beclomethasone, budesonide, flunisolide, fluticasone furoate or fluticasone propionate.
Croatian: Proizvodi dostupni u EU-u obuhvaćaju djelatne tvari beklometazon, budezonid, flunisolid, flutikazon furoat i flutikazon propionat.
English: The review was carried out by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which recommended that the product information for these medicines should be updated to adequately reflect current knowledge about the risks.
Croatian: Ocjenjivanje je proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC) pri Agenciji, koji je preporučio ažuriranje informacija o proizvodu za te lijekove kako bi odgovarajuće odražavale postojeća saznanja o rizicima.
English: Corticosteroids, also known as steroids, are anti-inflammatory medicines used for a wide range of conditions.
Croatian: Kortikosteroidi, poznati i kao steroidi, protuupalni su lijekovi koji se upotrebljavaju za širok raspon bolesti.
English: The review confirmed the risk of pneumonia with these products, which has been known for many years, and that it is common (can affect between 1 and 10 COPD patients in 100 using these medicines).
Croatian: U ocjenjivanju je potvrđeno da postoji rizik od upale pluća pri primjeni tih proizvoda, što je poznato već niz godina, te da se javlja često (može se javiti u između 1 i 10 na 100 bolesnika oboljelih od KOPB-a koji uzimaju te lijekove).
English: • The Agency's review included published data from randomised controlled clinical trials and a number of meta-analyses, as well as observational studies.
Croatian: • Ocjenjivanje Agencije obuhvatilo je objavljene podatke iz randomiziranih kontroliranih kliničkih ispitivanja i brojne metaanalize te opservacijska ispitivanja.
English: Overall the benefits of inhaled corticosteroid medicines in treating COPD continue to outweigh their risks and there should be no change to the way in which these medicines are used.
Croatian: Gledajući ukupno, koristi od inhalacijskih lijekova koji sadrže kortikosteroide za liječenje KOPB-a i dalje nadmašuju s njima povezane rizike i nije potrebno mijenjati način na koji se ti lijekovi primjenjuju.
English: The CHMP's opinion was then sent to the European Commission, which issued a final legally-binding decision valid throughout the EU.
Croatian: Mišljenje CHMP-a zatim je poslano Europskoj komisiji koja je objavila konačnu zakonski obvezujuću odluku koja vrijedi na cijelom području EU-a.
English: COPD is a long-term disease of the lungs in which the airways and air sacs in the lungs become damaged or blocked, leading to breathing difficulties.
Croatian: KOPB je dugotrajna bolest pluća pri čemu su dišni putovi i zračne vrećice u plućima oštećeni ili začepljeni, što dovodi do teškoća u disanju.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which adopted the Agency's opinion.
Croatian: Preporuke PRAC-a poslane su Odboru za lijekove za humanu uporabu (CHMP) koji je usvojio mišljenje Agencije.
English: • Patients need to alert their doctors if they start to get symptoms that suggest they are developing pneumonia, so that it can be identified and treated early.
Croatian: • Bolesnici se moraju hitno javiti svojem liječniku ako primijete simptome koji upućuju na razvoj upale pluća kako bi se bolest mogla utvrditi i liječiti u ranoj fazi.
English: On 28 April 2016 EMA completed a review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat chronic obstructive pulmonary disease (COPD).
Croatian: EMA je 28. travnja 2016. dovršila ocjenjivanje poznatog rizika od upale pluća (infekcije pluća) u bolesnika koji uzimaju inhalacijske lijekove koji sadrže kortikosteroide za liječenje kronične opstruktivne plućne bolesti (KOPB).
English: No clinical trials directly examined the risk of pneumonia with ICS head to head, and only indirect comparison in metaanalyses/systematic reviews or from observational studies is available.
Croatian: Rizik od upale pluća pri primjeni inhalacijskih lijekova koji sadrže kortikosteroide nije izravno ispitivan ni u jednom kliničkom ispitivanju i dostupna je samo neizravna usporedba metaanaliza / sustavnih ocjenjivanja ili iz opservacijskih studija.
English: When taken by inhalation they attach to receptors in the airways and cause a reduction in lung inflammation, which makes breathing easier.
Croatian: Kada se uzimaju inhalacijiom, vežu se za receptore u dišnim sustavima i ublažuju upalu pluća, što olakšava disanje.
English: Patients with COPD and their doctors should however be alert for signs and symptoms of pneumonia, bearing in mind that the clinical features of pneumonia overlap with those of a worsening (exacerbation) of the underlying disease.
Croatian: Međutim, bolesnici oboljeli od KOPB-a i njihovi liječnici moraju budno paziti na moguće znakove i simptome upale pluća, imajući na umu da se klinički znakovi upale pluća podudaraju sa znakovima pogoršanja (egzacerbacije) inicijalne bolesti.
English: The review did not find any conclusive evidence of differences in this risk for different products.
Croatian: U ocjenjivanju nisu utvrđeni nikakvi uvjerljivi dokazi o postojanju razlika u pogledu tog rizika među različitim proizvodima.