FrancophonIA/ELRC3.0 huggingface dataset:
English: White, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Croatian: Bijele, okrugle, bikonveksne, filmom obložene tablete s utisnutim ”APO” na jednoj strani i ”OLA” iznad ”2,5” na drugoj strani.
English: • Olanzapine Apotex 20 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘20' on the other side.
Croatian: • Olanzapine Apotex 20 mg raspadljive tablete za usta su žute, okrugle, plosnate sa radijalnim rubom i utisnutim »APO« na jednoj strani i »OL« iznad »20« na drugoj strani.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka raspadljiva tableta za usta sadrži 20 mg olanzapina.
English: INFORMATION IN BRAILLE Olanzapine Apotex 7.5 mg film-coated tablet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olanzapine Apotex 7,5 mg filmom obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/012
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/635/012
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 10 mg olanzapina.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Apotex Europe B.V.
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Apotex Europe B.V.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg olanzapine.
Croatian: TVARI Svaka tableta sadrži 2,5 mg olanzapina.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets olanzapine
Croatian: Olanzapine Apotex 2,5 mg filmom obložene tablete olanzapin
English: • Olanzapine Apotex 2.5 mg are white, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Croatian: • Olanzapine Apotex tablete od 2,5 mg su bijele, okrugle, bikonveksne filmom obložene tablete s utisnutim »APO« na jednoj strani i »OLA« iznad »2,5« na drugoj.
English: • Each Olanzapine Apotex 10 mg orodispersible tablet contains 10 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 10 mg raspadljiva tableta za usta sadrži 10 mg olanzapina.
English: Drug
Croatian: muškaraca
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg film-coated tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 10 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 2,5 mg filmom obložene tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 2,5 mg olanzapina.
English: • Each Olanzapine Apotex 15 mg orodispersible tablet contains 15 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 15 mg raspadljiva tableta za usta sadrži 15 mg olanzapina.
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘20' on the other side.
Croatian: Žute, okrugle, plosnate tablete ukošenog ruba s utisnutim ”APO” na jednoj strani i ”OL” iznad ”20” na drugoj strani.
English: Photosensitivity reaction Alopecia
Croatian: Poremećaji kože i potkožnog tkiva osip reakcija fotoosjetljivosti, alopecija,
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 20 mg orodispersible tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 20 mg raspadljive tablete za usta
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine.
Croatian: TVARI Svaka tableta sadrži 20 mg olanzapina.
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘7.5' on the other side.
Croatian: Bijele, okrugle, bikonveksne, filmom obložene tablete s utisnutim ”APO” na jednoj strani i ”OLA” iznad “7,5” na drugoj strani.
English: Olanzapine Apotex film-coated tablets are for oral use.
Croatian: Olanzapine Apotex filmom obložene tablete uzimaju se kroz usta.
English: INFORMATION IN BRAILLE Olanzapine Apotex 20 mg orodispersible tablet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olanzapine Apotex 20 mg raspadljive tablete za usta
English: • Olanzapine Apotex 5 mg and 10 mg orodispersible tablets are available in blisters packs of 28 , 56
Croatian: • Olanzapine Apotex raspadljive tablete za usta od 5 mg i 10 mg dostupne su u blister pakiranjima od 28, 56 i 98 tableta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/635/001
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg film-coated tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 5 mg filmom obložene tablete
English: • Olanzapine Apotex 5 mg and 10 mg film- coated tablets are available in blister packs of 28, 56
Croatian: • Olanzapine Apotex 5 mg i 10 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56 i 98 tableta.
English: • Each Olanzapine Apotex 5 mg orodispersible tablet contains 5 mg olanzapine.
Croatian: • Svaka Olanzapine Apotex 5 mg raspadljiva tableta za usta sadrži 5 mg olanzapina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka filmom obložena tableta sadrži 5 mg olanzapina.
English: • Olanzapine Apotex 10 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side.
Croatian: • Olanzapine Apotex tablete od 10 mg su okrugle, bikonveksne filmom obložene tablete s utisnutim »APO« na jednoj strani i »OLA« iznad »10« na drugoj.
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg film-coated tablet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olanzapine Apotex 10 mg filmom obložene tablete
English: Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Croatian: U kliničkim ispitivanjima olanzapina posturalna hipotenzija nije bila često uočena u starijih bolesnika.
English: • Olanzapine Apotex 5 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘5' on the other side.
Croatian: • Olanzapine Apotex 5 mg raspadljive tablete za usta su žute, okrugle, plosnate sa radijalnim rubom i utisnutim »APO« na jednoj strani i »OL« iznad »5« na drugoj strani.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka raspadljiva tableta za usta sadrži 15 mg olanzapina.
English: • Olanzapine Apotex 10 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Croatian: • Olanzapine Apotex 10 mg raspadljive tablete za usta su žute, okrugle, plosnate sa radijalnim rubom i utisnutim »APO« na jednoj strani i »OL« iznad »10« na drugoj strani.
English: INFORMATION IN BRAILLE Olanzapine Apotex 5 mg film-coated tablet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olanzapine Apotex 5 mg filmom obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/008-009 EU/1/10/635/017 BATCH NUMBER
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/635/008-009
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka raspadljiva tableta za usta sadrži 10 mg olanzapina.
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg orodispersible tablet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olanzapine Apotex 10 mg raspadljive tablete za usta
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg olanzapine.
Croatian: TVARI Svaka tableta sadrži 10 mg olanzapina.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 10 mg raspadljive tablete za usta
English: • Olanzapine Apotex 5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Croatian: • Olanzapine Apotex tablete od 5 mg su bijele, okrugle, bikonveksne filmom obložene tablete s utisnutim »APO« na jednoj strani i »OLA« iznad »5« na drugoj.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 15 mg orodispersible tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 15 mg raspadljive tablete za usta
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 20 mg orodispersible tablets olanzapine
Croatian: Olanzapine Apotex 20 mg raspadljive tablete za usta olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets
Croatian: NAZIV LIJEKA Olanzapine Apotex 5 mg raspadljive tablete za usta
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side.
Croatian: Bijele, okrugle, bikonveksne, filmom obložene tablete s utisnutim ”APO” na jednoj strani i ”OLA” iznad “10” na drugoj strani.
English: INFORMATION IN BRAILLE Olanzapine Apotex 5 mg orodispersible tablet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olanzapine Apotex 5 mg raspadljive tablete za usta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg olanzapine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka raspadljiva tableta za usta sadrži 5 mg olanzapina.
English: INFORMATION IN BRAILLE Olanzapine Apotex 15 mg orodispersible tablet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Olanzapine Apotex 15 mg raspadljive tablete za usta
English: • Olanzapine Apotex 15 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side
Croatian: • Olanzapine Apotex 15 mg raspadljive tablete za usta su žute, okrugle, plosnate sa radijalnim rubom i utisnutim »APO« na jednoj strani i »OL« iznad »15« na drugoj strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
Croatian: TVARI Svaka tableta sadrži 15 mg olanzapina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg olanzapine.
Croatian: TVARI Svaka tableta sadrži 5 mg olanzapina.
English: Olanzapine Apotex orodispersible tablets are for oral use.
Croatian: Olanzapine Apotex raspadljive tablete za usta uzimaju se kroz usta.
English: Magnesium stearate
Croatian: amnezija dizartrija mucanje
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 15 mg orodispersible tablets olanzapine
Croatian: Olanzapine Apotex 15 mg raspadljive tablete za usta olanzapin
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Croatian: Žute, okrugle, plosnate tablete ukošenog ruba s utisnutim ”APO” na jednoj strani i ”OL” iznad ”10” na drugoj strani.
English: Discontinuation symptoms7, 12
Croatian: Sindrom nemirnih nogu neuroleptički maligni sindrom (vidjeti dio 4.4)12, simptomi ustezanja7, 12
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side.
Croatian: Žute, okrugle, plosnate tablete ukošenog ruba s utisnutim ”APO” na jednoj strani i ”OL” iznad ”15” na drugoj strani.
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘5' on the other side.
Croatian: Žute, okrugle, plosnate tablete ukošenog ruba s utisnutim ”APO” na jednoj strani i ”OL” iznad ”5” na drugoj strani.
English: Tardive dyskinesia11 Amnesia 9
Croatian: tardivna diskinezija amnezija dizartrija mucanje
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Croatian: Bijele, okrugle, bikonveksne, filmom obložene tablete s utisnutim ”APO” na jednoj strani i ”OLA” iznad ”5” na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets olanzapine
Croatian: Olanzapine Apotex 5 mg raspadljive tablete za usta Olanzapine
English: Renal and/or hepatic impairment
Croatian: Oštećenjem bubrega i/ili jetre
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets olanzapine
Croatian: Olanzapine Apotex 10 mg raspadljive tablete za usta olanzapin
English: The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Croatian: Srednja vrijednost porasta AUC-a olanzapina iznosila je 52 % u žena nepušača, odnosno 108 % u muškaraca pušača.
English: Apotex Europe B.V. Archimedesweg 2, 2333 CN, Leiden, The Netherlands
Croatian: Archimedesweg 2 2333 CN Leiden Niozemska
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
Croatian: Pretrage povišene razine povišena razina alkalne povišen ukupni bilirubin prolaktina u plazmi fosfataze10,
English: There is a risk of feeling drowsy when you are given Olanzapine Apotex.
Croatian: Tijekom uzimanja Olanzapine Apotexa postoji rizik da se osjećate omamljeno.
English: EU/1/10/635/010-011 EU/1/10/635/018
Croatian: EU/1/10/635/018
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/010-011 EU/1/10/635/018 BATCH NUMBER
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/635/010-011
English: • Prostate problems
Croatian: • tegobe s prostatom
English: More information can be found here.
Croatian: Više informacija možete pronaći ovdje.
English: In stable angina, these symptoms appear during physical effort.
Croatian: U slučaju stabilne angine, ovi se simptomi pojavljuju tijekom fizičkog napora.
English: Further information on Procoralan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Procoralan.
Croatian: Više informacija o lijeku Procoralan možete naći na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Procoralan.
English: Procoralan (ivabradine)
Croatian: Procoralan (ivabradin)
English: Procoralan must not be taken with a number of other medicines.
Croatian: Lijek Procoralan ne smije se uzimati s brojnim drugim lijekovima.
English: The main measure of effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at the start and the end of each study.
Croatian: Glavna mjera učinkovitosti bila je koliko su dugo bolesnici mogli vježbati na biciklu ili traci za trčanje, što je mjereno na početku i kraju svakog ispitivanja.
English: The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Croatian: Glavna mjera učinkovitosti bilo je smanjenje rizika od smrti zbog srčanih problema i nesmrtonosnog srčanog udara.
English: Procoralan therefore reduces or prevents the symptoms of angina.
Croatian: Stoga Procoralan smanjuje ili sprječava simptome angine.
English: However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).
Croatian: Međutim, potrebno je napomenuti da su bolesnici iz tog ispitivanja primali više doze od preporučene doze (do 10 mg dva puta na dan).
English: It must not be used in women who are pregnant, breast-feeding or by women who could become pregnant and who are not using appropriate contraceptives.
Croatian: Ne smije se primjenjivati u žena koje su trudne, doje ili žena u reproduktivnoj dobi koje ne koriste odgovarajuće kontraceptive.
English: However, a fifth study in 728 patients showed that adding Procoralan to amlodipine did not provide an additional benefit.
Croatian: Međutim, peto ispitivanje na 728 bolesnika pokazalo je da dodavanje lijeka Procoralan amlodipinu nije donijelo dodatne koristi.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Croatian: U bolesnika starijih od 75 godina može se koristiti manja početna doza od 2,5 mg dva puta dnevno.
English: What measures are being taken to ensure the safe and effective use of Procoralan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Procoralan?
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Croatian: Preporučena početna doza iznosi 5 mg dva puta na dan uz obrok, koju liječnik može povećati na 7,5 mg dva puta na dan ili smanjiti na 2,5 mg (pola tablete od 5 mg) dva puta na dan ovisno o srčanoj frekvenciji i simptomima u bolesnika.
English: When these currents are blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Croatian: U slučaju kada su ove struje blokirane, srčana se frekvencija smanjuje, tako da srce mora manje raditi i potrebno mu je manje oksigenirane krvi.
English: Side effects reported with Procoralan are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Procoralan pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: For more information about using Procoralan, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Procoralan pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Procoralan received a marketing authorisation valid throughout the EU on 25 October 2005.
Croatian: Lijek Procoralan dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 25. listopada 2005.
English: What is Procoralan and what is it used for?
Croatian: Što je Procoralan i za što se primjenjuje?
English: The most common side effect with Procoralan (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Croatian: Najčešća nuspojava lijeka Procoralan (koja se može javiti u više od 1 na 10 osoba) jesu svjetlosni fenomeni ili „fosfeni” (privremena svjetlost u vidnom polju).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Procoralan have 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 u cilju sigurne i učinkovite primjene lijeka Procoralan nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Procoralan is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Croatian: Lijek Procoralan dostupan je u obliku tableta (od 5 i 7,5 mg) i izdaje se samo na liječnički recept.
English: Results showed that Procoralan was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Procoralan died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Croatian: Rezultati su pokazali da je Procoralan bio učinkovitiji od placeba u sprječavanju smrti zbog bolesti srca ili krvnih žila ili hospitalizacije zbog pogoršanog zatajenja srca: od bolesnika liječenih lijekom Procoralan, 24,5 % (793 od 3 241) umrlo je ili je bilo hospitalizirano zbog pogoršanja zatajenja srca, u usporedbi s 28,7 % (937 od 3 264) bolesnika koji su primali placebo.
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Croatian: Bio je jednako djelotvoran kao atenolol (beta blokator) u ispitivanju na 939 bolesnika te jednako djelotvoran kao amlodipin (drugi lijek za liječenje angine) u ispitivanju na 1 195 bolesnika.
English: Other information about Procoralan
Croatian: Ostale informacije o lijeku Procoralan
English: Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Croatian: Procoralan se ne smije primjenjivati u bolesnika koji imaju srčanu frekvenciju u mirovanju manju od 70 otkucaja u minuti, vrlo nizak krvni tlak, različite tipove srčanog poremećaja (uključujući kardiogeni šok, poremećaj ritma, srčani udar, nestabilno ili akutno (iznenadno) zatajenje srca i nestabilnu anginu) ili ozbiljne probleme s jetrom.
English: As for all medicines, data on the use of Procoralan are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Procoralan kontinuirano se prate.
English: An overview of Procoralan and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Procoralan i zašto je odobren u EU-u
English: The European Medicines Agency concluded that Procoralan was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Croatian: Europska agencija za lijekove zaključila je da je dokazano kako je lijek Procoralan učinkovit u liječenju kronične angine s prihvatljivim sigurnosnim profilom kako bi osigurao alternativno liječenje za bolesnike koji ne mogu uzimati beta blokatore ili čija se bolest njima ne može kontrolirati.
English: By lowering the heart rate, Procoralan reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Croatian: Snižavanjem srčane frekvencije Procoralan ublažava napor za srce te stoga usporava napredak zatajenja srca i poboljšava simptome.
English: Why is Procoralan authorised in the EU?
Croatian: Zašto je lijek Procoralan odobren u EU-u?
English: A sixth study compared Procoralan with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Croatian: U šestom ispitivanju lijek Procoralan uspoređen je s placebom u 19 102 bolesnika s koronarnom arterijskom bolesti i bez kliničkog zatajenja srca.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
Croatian: Posebna podskupina bolesnika u ovom ispitivanju imala je malo, ali značajno povećanje kombiniranog rizika od kardiovaskularne smrti ili nesmrtonosnog srčanog udara pri primjeni lijeka Procoralan u usporedbi s placebom (3,4 % odnosno 2,9 % u stopi pojave godišnje).
English: It also concluded that Procoralan was effective in long-term heart failure with an acceptable safety profile.
Croatian: Također je zaključila da je Procoralan učinkovit u liječenju kroničnog zatajenja srca s prihvatljivim sigurnosnim profilom.
English: Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Croatian: Procoralan se također primjenjuje u bolesnika s kroničnim zatajenjem srca (kada srce ne može opskrbljivati ostatak tijela s dovoljno krvi) koji imaju normalni srčani ritam i čija je srčana frekvencija najmanje 75 otkucaja po minuti.
English: Procoralan was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Croatian: Lijek Procoralan uspoređen je s placebom (prividno liječenje) i drugim terapijama u pet glavnih ispitivanja koja su obuhvatila više od 4 000 odraslih osoba s kroničnom stabilnom anginom.
English: What are the risks associated with Procoralan?
Croatian: Koji su rizici povezani s lijekom Procoralan?
English: The active substance in Procoralan, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Croatian: Djelatna tvar u lijeku Procoralan, ivabradin, djeluje inhibirajući „If struje” u sinusnom čvoru, „elektrostimulatoru” srca koji kontrolira kontrakcije srca i regulira srčanu frekvenciju.