FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Croatian: KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta sadržava 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
English: After 8 weeks of treatment, each of the combinations was statistically significantly superior to both amlodipine monotherapy doses in reducing systolic and diastolic blood pressures ( 13.6/ 9.4 mmHg, 15.0/ 10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus 6.2/ 5.7 mmHg, 11.1/ 8.0 mmHg with amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 42 %, 56.7 % with amlodipine 5 mg and 10 mg).
Croatian: Nakon 8 tjedana liječenja, svaka od kombinacija bila je statistički superiorna u odnosu na obje monoterapijske doze amlodipina u snižavanju sistoličkog i dijastoličkog krvnog tlaka (-13,6/-9,4 mmHg, -15,0/-10,6 mmHg uz 40 mg/5 mg, 80 mg/5 mg u odnosu na -6,2/5,7 mmHg, -11,1/-8,0 mmHg uz amlodipin 5 mg i 10 mg, a postignuta je viša stopa kontrole dijastoličkog krvnog tlaka u usporedbi s relevantnim monoterapijama (56,7 %, 63,8 % uz 40 mg/5 mg i 80 mg/5 mg u odnosu na 42 %, 56,7 % uz amlodipin 5 mg i 10 mg).
English: Twynsta 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Croatian: Twynstu 40 mg/5 mg mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipinom od 5 mg.
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Croatian: Svaka tableta sadržava 40 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets telmisartan/amlodipine
Croatian: NAZIV LIJEKA Twynsta 80 mg/5 mg tablete telmisartan/amlodipin
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Croatian: Svaka tableta sadržava 80 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets telmisartan/amlodipine
Croatian: NAZIV LIJEKA Twynsta 80 mg/10 mg tablete telmisartan/amlodipin
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Croatian: Svaka tableta sadržava 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister sa 7 tableta - 80 mg/10 mg
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Croatian: Svaka tableta sadržava 40 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister sa 7 tableta - 40 mg/10 mg
English: Package leaflet: Information for the user Twynsta 80 mg/10 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacije za korisnika Twynsta 80 mg/10 mg tablete telmisartan/amlodipin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister djeljiv na jedinične doze sa 10 tableta - 80 mg/10 mg
English: Package leaflet: Information for the user Twynsta 40 mg/10 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacije za korisnika Twynsta 40 mg/10 mg tablete telmisartan/amlodipin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister sa 7 tableta - 80 mg/5 mg
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Croatian: Twynsta 40 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na bijelom sloju.
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets)
Croatian: EU/1/10/648/001 (14 tableta) EU/1/10/648/002 (28 tableta) EU/1/10/648/003 (30 x 1 tableta) EU/1/10/648/004 (56 tableta) EU/1/10/648/005 (90 x 1 tableta) EU/1/10/648/006 (98 tableta)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/10 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister djeljiv na jedinične doze sa 10 tableta - 40 mg/10 mg
English: Twynsta 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg.
Croatian: Twynsta 80 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Twynstom 40 mg/5 mg.
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Croatian: EU/1/10/648/001 (14 tableta) EU/1/10/648/002 (28 tableta) EU/1/10/648/003 (30 x 1 tableta) EU/1/10/648/004 (56 tableta) EU/1/10/648/005 (90 x 1 tableta) EU/1/10/648/006 (98 tableta) EU/1/10/648/007 (360 (4 x 90 x 1) tableta)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister djeljiv na jedinične od 10 tableta - 80 mg/5 mg
English: Package leaflet: Information for the user Twynsta 40 mg/5 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacije za korisnika Twynsta 40 mg/5 mg tablete telmisartan/amlodipin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister sa 7 tableta - 40 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets telmisartan/amlodipine
Croatian: NAZIV LIJEKA Twynsta 40 mg/5 mg tablete telmisartan/amlodipin
English: Package leaflet: Information for the user Twynsta 80 mg/5 mg tablets Telmisartan/Amlodipine
Croatian: Uputa o lijeku: Informacije za korisnika Twynsta 80 mg/5 mg tablete telmisartan/amlodipin
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Croatian: Twynsta 80 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na bijelom sloju.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/10 mg tablets telmisartan/amlodipine
Croatian: NAZIV LIJEKA Twynsta 40 mg/10 mg tablete telmisartan/amlodipin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/5 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister djeljiv na jedinične doze sa 10 tableta - 40 mg/5 mg
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Croatian: Twynsta 80 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na bijelom sloju.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 40 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na bijelom sloju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/648/007 (360 (4 x 90 x 1) tableta)
English: MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets)
Croatian: EU/1/10/648/022 (14 tableta) EU/1/10/648/023 (28 tableta) EU/1/10/648/024 (30 x 1 tableta) EU/1/10/648/025 (56 tableta) EU/1/10/648/026 (90 x 1 tableta) EU/1/10/648/027 (98 tableta)
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Croatian: Twynsta 40 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na bijelom sloju.
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets)
Croatian: EU/1/10/648/008 (14 tableta) EU/1/10/648/009 (28 tableta) EU/1/10/648/010 (30 x 1 tableta) EU/1/10/648/011 (56 tableta) EU/1/10/648/012 (90 x 1 tableta) EU/1/10/648/013 (98 tableta)
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets)
Croatian: EU/1/10/648/015 (14 tableta) EU/1/10/648/016 (28 tableta) EU/1/10/648/017 (30 x 1 tableta) EU/1/10/648/018 (56 tableta) EU/1/10/648/019 (90 x 1 tableta) EU/1/10/648/020 (98 tableta)
English: Twynsta 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone.
Croatian: Twynsta 40 mg/10 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipinom od 10 mg.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 80 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Croatian: EU/1/10/648/022 (14 tableta) EU/1/10/648/023 (28 tableta) EU/1/10/648/024 (30 x 1 tableta) EU/1/10/648/025 (56 tableta) EU/1/10/648/026 (90 x 1 tableta) EU/1/10/648/027 (98 tableta) EU/1/10/648/028 (360 (4 x 90 x 1) tableta)
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na bijelom sloju.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 40 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na bijelom sloju.
English: Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat,
Croatian: Smanjeni broj bijelih krvnih stanica (leukopenija), niski broj trombocita (tromobcitopenija), alergijska reakcija (npr. osip, svrbež, otežano disanje, piskanje pri disanju, otečenost lica ili niski krvni tlak), povećane vrijednosti šećera u krvi, nekontrolirani pokreti grčenja ili trzanja, srčani udar, nepravilno kucanje srca, upala krvnih žila, upala gušterače, upala želučane sluznice (gastritis), upala jetre, žutilo kože (žutica), povišene vrijednosti jetrenih enzima sa žuticom, brzo oticanje kože i sluznice
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/648/021 (360 (4 x 90 x 1) tableta)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/648/014 (360 (4 x 90 x 1) tableta)
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Croatian: EU/1/10/648/008 (14 tableta) EU/1/10/648/009 (28 tableta) EU/1/10/648/010 (30 x 1 tableta) EU/1/10/648/011 (56 tableta) EU/1/10/648/012 (90 x 1 tableta) EU/1/10/648/013 (98 tableta) EU/1/10/648/014 (360 (4 x 90 x 1) tableta)
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Croatian: EU/1/10/648/015 (14 tableta) EU/1/10/648/016 (28 tableta) EU/1/10/648/017 (30 x 1 tableta) EU/1/10/648/018 (56 tableta) EU/1/10/648/019 (90 x 1 tableta) EU/1/10/648/020 (98 tableta) EU/1/10/648/021 (360 (4 x 90 x 1) tableta)
English: Uncommon visual impairment
Croatian: Tablični prikaz nuspojava
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Croatian: Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na bijelom sloju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/10 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA OD 360 (4 PAKIRAANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 40 mg/10 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/648/028 (360 (4 x 90 x 1) tableta)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/10 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/5 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/5 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 40 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/10 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKIRANJU OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/10 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKIRANJU OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 40 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/5 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKIRANJU OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/5 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKIRANJU OD 360 (4 PAKIRANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 40 mg/5 mg
English: The company also presented data from the published literature.
Croatian: Tvrtka je također dostavila podatke iz objavljene literature.
English: The three main studies involved a total of almost 113,000 people.
Croatian: Tri glavna ispitivanja obuhvatila su ukupno 113.000 osoba.
English: Once prepared, the suspension should be drunk within two hours.
Croatian: Nakon što je pripremljena, suspenziju treba popiti u roku od dva sata.
English: This subunit is not toxic by itself.
Croatian: Ova podjedinica nije toksična sama po sebi.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to protect itself against a disease.
Croatian: Cjepiva djeluju „učeći“ imunosni sustav (prirodnu obranu tijela) kako da se štiti protiv bolesti.
English: The full EPAR for Dukoral can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Dukoral nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The course should be completed at least one week before potential exposure to cholera.
Croatian: Cijeli ciklus cijepljenja treba završiti najmanje tjedan dana prije potencijalnog izlaganja koleri.
English: Other information about Dukoral:
Croatian: Ostale informacije o lijeku Dukoral:
English: Food, drink and other medicines taken by mouth should be avoided for one hour before and one hour after each dose of Dukoral.
Croatian: Hranu, pića i druge lijekove koji se uzimaju peroralno treba izbjegavati jedan sat prije i jedna sat nakon svake doze lijeka Dukoral.
English: Because Dukoral has been in use in Sweden since 1991, the company presented the results of three main studies that had already been carried out in order to support the use of Dukoral.
Croatian: Budući da se Dukoral primjenjuje u Švedskoj od 1991., tvrtka je dostavila rezultate tri glavna ispitivanja koja su već provedena u kako bi se potkrijepila uporaba lijeka Dukoral.
English: The CHMP noted that the risk of cholera for regular tourists is minor, but that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics.
Croatian: CHMP je zaključio da je rizik od kolere u prosječnih turista malen, no lijek Dukoral može biti važan za određene grupe, poput zdravstvenih radnika u slučaju epidemije kolere.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral on 28 April 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Dukoral na snazi u Europskoj uniji od 28. travnja 2004.
English: Dukoral should not replace standard protective measures against cholera, including advice on diet and hygiene.
Croatian: Dukoral ne smije zamijeniti standardne zaštitne mjere protiv kolere, uključujući savjet o prehrani i higijeni.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to cholera bacteria.
Croatian: U buduće, imunosni će sustav moći brže ako je izložen bakteriji kolere.
English: It is available as a suspension in a bottle together with effervescent granules in a sachet.
Croatian: Dostupno je kao suspenzija u boci zajedno s drugim šumećim granulama u vrećici.
English: Dukoral is used in adults, adolescents and children from two years of age who will be visiting high-risk areas.
Croatian: Dukoral se koristi u odraslih osoba, adolescenata i djece u dobi od dvije godine i starijih, koji planiraju posjetiti područja visokog rizika.
English: Dukoral should be given according to official recommendations, taking into account where cholera is found and the risk of contracting the disease.
Croatian: Dukoral treba primjenjivati u skladu sa službenim preporukama, uzimajući u obzir područja gdje je kolera prisutna i rizik od zaraze bolešću.
English: In adults, two vaccine doses were shown to be as effective as three.
Croatian: Utvrđeno je da su u odraslih osoba dvije doze cjepiva podjednako djelotvorne kao i tri.
English: Dukoral cholera vaccine (inactivated, oral)
Croatian: Dukoral cjepivo protiv kolere (inaktivirano, peroralno)
English: In all three studies, the main measure of effectiveness was the ‘protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and after receiving placebo.
Croatian: U sva tri ispitivanja, glavna mjera djelotvornosti bila je „zaštitna djelotvornost“ cjepiva, izračunata uspoređujući broj osoba u ispitivanjima u kojih se razvila kolera nakon primanja lijeka Dukoral i nakon primanja placeba.
English: The people in the final study also received a booster dose 10 to 12 months later.
Croatian: Osobe u posljednjem ispitivanju također su primile booster dozu nakon 10 do 12 mjeseci.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, diarrhoea, and abdominal (tummy) pain, cramps, gurgling (gas) or discomfort.
Croatian: No, sljedeće nuspojave mogu se javiti kod 1 do 10 bolesnika na 1.000: glavobolja, proljev i bol u abdomenu (trbuhu), grčevi, nadutost (plinovi) ili nelagoda.
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 Dukoral.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Dukoral.
English: The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with placebo.
Croatian: Prvo je ispitivanje obuhvatilo više od 89.000 osoba u Bangladešu, te je usporedilo Dukoral s istim cjepivom bez toksina i s placebom.
English: Its use should be postponed in patients with a short-lived illness affecting the stomach or gut, or with a fever.
Croatian: Primjena se treba odgoditi u bolesnika s kratkoročnom bolesti koja zahvaća želudac ili crijeva ili s groznicom.
English: The studies took place in areas where cholera is found.
Croatian: Ispitivanja su se održala u područjima gdje je kolera prisutna.
English: Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is caught from contaminated food or water and causes severe diarrhoea).
Croatian: Dukoral se koristi za imunizaciju protiv kolere (vrlo ozbiljne bolesti koju uzrokuje V. cholerae, od koje se obolijeva uslijed konzumacije zaražene hrane ili vode i uzrokuje teški proljev).