FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that PritorPlus be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka PritorPlus u promet.
English: The full EPAR for PritorPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek PritorPlus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom PritorPlus pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: In four of these studies, PritorPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Croatian: PritorPlus je uspoređen s placebom (prividnim liječenjem) i s telmisartanom koji je samostalno uzimalo ukupno 2272 bolesnika.
English: The dose of PritorPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Croatian: Doza lijeka PritorPlus koja će se primjenjivati ovisi o dozi telmisartana koju je bolesnik prethodno uzimao: bolesnici koji su primali 40 mg telmisartana trebaju uzimati tablete od 40/12,5 mg, a bolesnici koji su primali 80 mg telmisartana trebaju uzimati tablete od 80/12,5 mg.
English: PritorPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Croatian: PritorPlus je bio djelotvorniji u snižavanju dijastoličkog krvnog tlaka u odnosu na monoterapiju telmisartanom i placebo.
English: PritorPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Croatian: PritorPlus je lijek koji sadrži dvije djelatne tvari, telmisartan i hidroklorotiazid.
English: The CHMP decided that PritorPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Croatian: CHMP je odlučio da koristi od lijeka PritorPlus nadmašuju s njim povezane rizike za liječenje esencijalne hipertenzije u bolesnika čiji se krvni tlak ne kontrolira primjereno monoterapijom telmisartana.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to PritorPlus.
Croatian: Tablete od 80/25 mg koriste se u bolesnika čiji se krvni tlak ne može kontrolirati primjenom tableta jačine 80/12,5 mg ili koji su stabilizirani primjenom dvije djelatne tvari koje se uzimaju zasebno prije prelaska na PritorPlus.
English: It is available as tablets (40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Croatian: Dostupan je u obliku tableta (150 mg ili 80 mg irbesartana i 12,5 mg hidroklorotiazida; 80 mg irbesartana i 25 mg hidroklorotiazida).
English: PritorPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Croatian: PritorPlus se ne smije koristiti ni kod bolesnika s teškim jetrenim, bubrežnim ili žučnim problemima, s preniskom razinom kalija u krvi niti s previsokom razinom kalcija u krvi.
English: In patients who were not controlled on the 80/12.5 mg tablet, switching to the 80/25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.
Croatian: U bolesnika koji nisu odgovarajuće kontrolirani tabletom jačine 80/12,5 mg, prelazak na tabletu jačine 80/25 mg bio je djelotvorniji u snižavanju dijastoličkog tlaka u odnosi na ostanku na slabijoj dozi.
English: PritorPlus contains two active substances, telmisartan and hydrochlorothiazide.
Croatian: PritorPlus sadrži dvije djelatne tvari, telmisartan i hidroklorotiazid.
English: For the full list of all side effects reported with PritorPlus, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka PritorPlus potražite u uputi o lijeku.
English: What benefit has PritorPlus shown during the studies?
Croatian: Koje su koristi lijeka PritorPlus utvrđene u ispitivanjima?
English: What is PritorPlus used for?
Croatian: Za što se PritorPlus koristi?
English: How is PritorPlus used?
Croatian: Kako se PritorPlus koristi?
English: How has PritorPlus been studied?
Croatian: Kako je PritorPlus ispitivan?
English: PritorPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Croatian: PritorPlus se koristi kod odraslih bolesnika s esencijalnom hipertenzijom (visokim krvnim tlakom) koja se ne može na odgovarajući način kontrolirati samo irbesartanom ili samo hidroklorotiazidom. „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
English: How does PritorPlus work?
Croatian: Kako djeluje PritorPlus?
English: Treatment can be repeated every three months if necessary.
Croatian: Liječenje se može ponoviti svaka tri mjeseca ako je potrebno.
English: If necessary, the other eye can be treated with the laser immediately afterwards.
Croatian: Ako je potrebno, odmah potom laserom se može liječiti i drugo oko.
English: The full EPAR for Visudyne can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Visudyne nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Although the first study in occult disease showed some effectiveness, this was not confirmed in the second study.
Croatian: Iako je prvo ispitivanje pokazalo određenu učinkovitost kod okultne bolesti, to nije potvrđeno u drugom ispitivanju.
English: Visudyne is used to treat adults with:
Croatian: Visudyne se koristi za liječenje odraslih osoba s:
English: This was followed by a confirmatory study in a further 364 patients that was carried out at the request of the CHMP.
Croatian: Nakon toga je uslijedilo još jedno potvrdno ispitivanje na dodatna 364 bolesnika koje je provedeno na zahtjev CHMP-a.
English: The most common side effects with Visudyne (seen in between 1 and 10 patients in 100) are hypercholesteraemia (high blood cholesterol levels), hypersensitivity (allergic reactions), severely reduced visual acuity (very unclear vision), visual impairment (such as unclear vision, blurred fuzzy vision or flashes of light), defects in the visual field (such as small areas of reduced vision, grey or dark haloes, and black spots), dyspnoea (shortness of breath), nausea (feeling sick), photosensitivity reactions (sunburn-like reactions following exposure to light), reactions at the injection site (pain, swelling, inflammation and leakage of fluid from the veins), asthenia (weakness), infusion-related pain (mainly chest and back pain), syncope (fainting), headache and dizziness.
Croatian: Najčešće nuspojave lijeka Visudyne (primijećene u između 1 i 10 na 100 bolesnika) su hiperkolesterolemija (visoka razina kolesterola u krvi), preosjetljivost (alergijske reakcije), ozbiljno smanjena vidna oštrina (vrlo nejasan vid), oštećenje vida (nejasan vid, zamagljen vid ili bljeskovi svjetlosti), nedostaci u vidnom polju (kao što su mala područja smanjenog vida, sive ili tamne aureole i crne mrlje), dispneja (otežano disanje), mučnina (osjećaj slabosti), fotosenzitivne reakcije (reakcije slične opekotinama od sunca nakon izlaganja svjetlu), reakcije na mjestu uboda (bol, oteklina, upala i istjecanje tekućine iz vene), astenija (slabost), bol povezana s infuzijom (uglavnom u prsima i leđima), sinkopa (nesvjestica), glavobolja i vrtoglavica.
English: The dose depends on the body surface area (calculated using the patient's height and weight).
Croatian: Doza ovisi o površini tijela (koja se izračunava na osnovi visine i tjelesne težine bolesnika).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Visudyne on 27 July 2000.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Visudyne na snazi u Europskoj uniji od 27. srpnja 2000.
English: What is the risk associated with Visudyne?
Croatian: Koji su rizici povezani s lijekom Visudyne?
English: A patient was classified as a responder if the number of letters that they could see increased, stayed the same, or fell by less than 15.
Croatian: Bolesnik je svrstan u skupinu bolesnika koji su pozitivno reagirali na lijek ako se povećao broj slova koje može vidjeti, ako je taj broj ostao isti ili se smanjio za manje od 15.
English: This helps to close up the abnormal blood vessels that cause AMD.
Croatian: To pomaže u zatvaranju abnormalnih krvnih žila koje uzrokuju AMD.
English: What is Visudyne?
Croatian: Što je Visudyne?
English: In all three studies, the main measure of effectiveness was the number of patients who had responded to treatment after a year, measured using a standard eye test chart.
Croatian: U sva tri ispitivanja, glavno mjerilo učinkovitosti bio je broj bolesnika s pozitivnim odgovorom na liječenje nakon godine dana koji se mjerio uz pomoć standardnog dijagrama za ispitivanje očiju.
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 Visudyne.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za njegovo korištenje.
English: It is used in ‘photodynamic therapy', a method of treatment that uses light (generally from a laser) to activate a photosensitising agent.
Croatian: Koristi se u „fotodinamičkoj terapiji”, metodi liječenja u okviru koje se koristi svjetlo (obično iz lasera) radi aktivacije fotosenzitivnog agensa.
English: The second step, 15 minutes after the start of the infusion, is the activation of Visudyne in the eye using light generated by a laser beam.
Croatian: Drugi korak, 15 minuta nakon početka infuzije, jest aktiviranje lijeka Visudyne u oku uz pomoć svjetla koje stvara laserska zraka.
English: Some of these patients went on to receive Visudyne for up to five years.
Croatian: Neki od tih bolesnika primali su Visudyne do najviše pet godina.
English: For more information about treatment with Visudyne, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Visudyne pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Other information about Visudyne:
Croatian: Ostale informacije o lijeku Visudyne:
English: It is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Dostupan je kao prašak koji se koristi za pripremu otopine za intravensku infuziju (drip).
English: Visudyne must not be used in patients with porphyria (an inability to break down chemicals called porphyrins) or in patients with severe liver disease.
Croatian: Visudyne se ne smije primjenjivati u bolesnika s porfirijom (nemogućnost razgradnje kemikalija koje se nazivaju porfirini) ili u bolesnika s teškom bolesti jetre.
English: • choroidal neovascularisation caused by pathologic myopia (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
Croatian: • koroidnom neovaskularizacijom uzrokovanom patološkom miopijom (teškim oblikom kratkovidnosti kod kojeg jabučica oka nastavlja rasti i postaje veća nego što bi trebala biti).
English: This document is a summary of the European Public Assessment Report (EPAR) for Visudyne.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Visudyne.
English: • the ‘wet' form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye.
Croatian: • „vlažnim” oblikom senilne makularne degeneracije (AMD), bolesti koja utječe na središnji dio mrežnice (koji se naziva makula) u stražnjem dijelu oka.
English: When the laser light is shone into the eye, verteporfin is activated and generates toxic oxygen molecules which block blood vessels, damage and even kill cells.
Croatian: Nakon što se oko ozrači laserskim svjetlom, verteporfin se aktivira stvarajući toksične molekule kisika koje blokiraju krvne žile te oštećuju i čak ubijaju stanice.
English: The CHMP decided that Visudyne's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Visudyne nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za stavljanje u promet.
English: The benefit of Visudyne was maintained for up to five years for both diseases.
Croatian: Koristi lijeka Visudyne održane su do najviše pet godina u slučaju obiju bolesti.
English: Visudyne was more effective than placebo in the studies of AMD and pathologic myopia.
Croatian: Visudyne se pokazao učinkovitijim od placeba u ispitivanjima oboljelih od AMD-a i patološke miopije.
English: In the two studies of wet AMD, 61% of the patients receiving Visudyne had responded to treatment after a year (246 out of 402), compared with 46% of those receiving placebo (96 out of 207).
Croatian: U dvama ispitivanjima vlažnog AMD-a, 61 % bolesnika koji su primili Visudyne pozitivno je reagiralo na liječenje nakon godine dana (246 od 402) u usporedbi s njih 46 % koji su primili placebo (96 od 207).
English: Visudyne is used when the neovascularisation is ‘predominantly classic' (when the blood vessels affected are well defined on an eye scan) and subfoveal (occurs in the area under the fovea - the central area of the macula);
Croatian: Visudyne se koristi kada je neovaskularizacija „predominantno klasična” (kada su pogođene krvne žile jasno definirane na skenu oka) i kada je subfovealna (pojavljuje se u području pod foveom - središnjim područjem makule;
English: Visudyne is used when the neovascularisation is subfoveal
Croatian: Visudyne se koristi kada je neovaskularizacija subfovealna.
English: The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling.
Croatian: Vlažni oblik AMD-a uzrokovan je koroidnom neovaskularizacijom (nenormalnim rastom krvnih žila ispod makule) koja može uzrokovati propuštanje tekućine i krvi te oticanje.
English: In the study of pathologic myopia, 86% of the patients receiving Visudyne had responded after a year (70 out of 81), compared with 67% of those receiving placebo (26 out of 39).
Croatian: U ispitivanju oboljelih od patološke miopije, 86 % bolesnika koji su primili Visudyne pozitivno je reagiralo na liječenje nakon godine dana (70 od 81) u usporedbi s njih 67 % koji su primili placebo (26 od 39).
English: Visudyne has been compared with placebo (a dummy treatment) in two studies involving a total of 609 AMD patients with classic subfoveal neovascularisation, and in one study involving 120 patients with neovascularisation caused by pathologic myopia.
Croatian: Visudyne je uspoređivan s placebom (prividnim liječenjem) u okviru dvaju ispitivanja koja su uključivala ukupno 609 bolesnika s AMD-om s klasičnom subfovealnom neovaskularizacijom te u okviru jednog ispitivanja koje je uključivalo 120 bolesnika s neovaskularizacijom uzrokovanom patološkom miopijom.
English: Treatment with Visudyne is a two-step process.
Croatian: Liječenje lijekom Visudyne postupak je koji se provodi u dva koraka.
English: Why has Visudyne been approved?
Croatian: Zašto je lijek Visudyne odobren?
English: First, the patient receives Visudyne as an infusion into a vein lasting 10 minutes.
Croatian: Bolesnik prvo prima Visudyne putem intravenske infuzije u trajanju od 10 minuta.
English: Visudyne is a medicine that contains the active substance verteporfin.
Croatian: Visudyne je lijek koji sadrži djelatnu tvar verteporfin.
English: When Visudyne is injected into a patient, verteporfin is distributed within the body through the blood vessels, including the blood vessels at the back of the eye.
Croatian: Nakon što se Visudyne injektira u bolesnika, verteporfin se širi tijelom putem krvnih žila, uključujući putem žila u stražnjem dijelu oka.
English: What benefit has Visudyne shown during the studies?
Croatian: Koje koristi lijeka Visudyne su dokazane u ispitivanjima?
English: Visudyne has also been compared with placebo in ‘occult' subfoveal choroidal neovascularisation (when the blood vessels affected are not well defined on the scan), in a two-year study involving 339 patients.
Croatian: Visudyne je uspoređivan s placebom i u slučajevima „okultne” subfovealne koroidne neovaskularizacije (kada pogođene krvne žile nisu jasno definirane na skenu) u okviru dvogodišnjeg ispitivanja na 339 bolesnika.
English: Visudyne should only be given by ophthalmologists (eye specialists) who have experience in the management of patients with AMD or pathological myopia.
Croatian: Visudyne smiju davati samo oftalmolozi (specijalisti za oči) s iskustvom u liječenju bolesnika s AMD-om ili patološkom miopijom.
English: What is Visudyne used for?
Croatian: Za što se Visudyne koristi?
English: The benefit of Visudyne in occult subfoveal choroidal neovascularisation has not been established.
Croatian: Koristi lijeka Visudyne kod okultne subfovealne koroidne neovaskularizacije nisu utvrđene.
English: The active substance in Visudyne, verteporfin, is a photosensitising agent (a substance that changes when exposed to light).
Croatian: Djelatna tvar u lijeku Visudyne, verteporfin, fotosenzitivni je agens (tvar koja se mijenja pri izloženosti svjetlu).
English: How does Visudyne work?
Croatian: Kako djeluje Visudyne?
English: For the full list of restrictions and side effects reported with Visudyne, see the package leaflet.
Croatian: Potpuni popis ograničenja i nuspojava zabilježenih pri primjeni lijeka Visudyne potražite u uputi o lijeku.
English: How is Visudyne used?
Croatian: Kako se Visudyne koristi?
English: How has Visudyne been studied?
Croatian: Kako je Visudyne ispitivan?
English: FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM AVAILABLE DATA)
Croatian: NEPOZNATA UČESTALOST (NE MOŽE SE PROCIJENITI IZ DOSTUPNIH PODATAKA)
English: For all patients:
Croatian: Za sve bolesnike:
English: They may decide to stop the infusion.
Croatian: Oni mogu odlučiti prekinuti infuziju.
English: - if you have any infections, including infections which have spread to your blood stream.
Croatian: - ako imate bilo kakve infekcije, uključujući infekcije koje su se proširile u Vaš krvotok.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, otrovanja i proceduralne komplikacije
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Croatian: CHMP se slaže sa znanstvenim zaključcima koje je donio PRAC.
English: The following information is intended for healthcare professionals only (see Section 3):
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima (vidjeti dio 3):
English: Only one case of minor rash was observed.
Croatian: Bio je opažen samo jedan slučaj manjeg osipa.
English: You will be lying down and your blood pressure and pulse will be monitored.
Croatian: Prilikom toga ćete ležati i pratit će se Vaš krvni tlak i puls.
English: A risk to breastfeeding newborns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: Immunologic Disease or Infection
Croatian: Imunološka bolest ili infekcija
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Croatian: Važno je da obavijestite liječnika ako ste trudni, mislite da ste možda trudni ili planirate zatrudnjeti.
English: These reactions can be associated with heart and circulation complications, loss of consciousness and may result in death.
Croatian: Te reakcije mogu biti povezane sa srčanim i cirkulacijskim komplikacijama, gubitkom svijesti i mogu za posljedicu imati smrt.
English: Pharmacotherapeutic group: Not yet assigned, ATC code: Not yet assigned
Croatian: Farmakoterapijska skupina: još nije dodijeljena, ATK oznaka: još nije dodijeljena
English: - if you have systemic lupus erythematosus.
Croatian: - ako imate sistemski lupus erythematosus.
English: 31 July 2016
Croatian: 31. srpnja 2016.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: If you are pregnant, you should not receive Rienso.
Croatian: Ako ste trudni, ne smijete primiti Rienso.
English: There is no evidence that the risk of hypersensitivity reactions as such is increased in elderly patients however these patients have an increased risk of complications.
Croatian: Nema dokaza da je rizik od reakcija preosjetljivosti kao takav povećan u starijih bolesnika, međutim, u tih je bolesnika bio povećan rizik od komplikacija.
English: For the same reason also talk to your doctor or radiographer if you have been given Rienso within the past 6 months and an MRI is subsequently arranged.
Croatian: Zbog istog razloga, također se obratite svom liječniku ili radiologu ako ste dobili Rienso u prethodnih 6 mjeseci, a MRI je bio dogovoren nakon toga.
English: Re-treatment / Long term use
Croatian: Ponovno liječenje / dugotrajna primjena
English: - if you have problems with your immune system.
Croatian: - ako imate tegobe s imunološkim sustavom.
English: As seen from clinical data there is no evidence that these effects seen in female rats are relevant for humans.
Croatian: Kao što se vidi iz kliničkih podataka, nema dokaza da su ti učinci viđeni kod ženki štakora, relevantni za ljude.
English: One of these three cases was also characterized as an anaphylactoid reaction.
Croatian: Jedan od ta tri slučaja također je bio okarakteriziran kao anafilaktoidna reakcija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 June 2012
Croatian: Datum prvog odobrenja: 15. lipnja 2012.
English: Your doctor will decide if additional doses of Rienso are needed and for how long.
Croatian: Liječnik će odlučiti je li potrebno davati dodatne doze lijeka Rienso i koliko dugo.
English: 31 October 2016
Croatian: 31. listopada 2016.
English: If you are older than 65 years or have an underlying condition, such as liver or heart disease, the risk of having severe consequences including death may be higher after a serious allergic reaction.
Croatian: Ako ste stariji od 65 godina ili imate neku osnovnu bolest, poput bolesti jetre ili srca, rizik od teških posljedica, uključujući smrt, može biti veći nakon ozbiljne alergijske reakcije.
English: If you become pregnant during treatment, you must ask your doctor for advice.
Croatian: Ako zatrudnite za vrijeme liječenja, morate potražiti savjet liječnika.
English: You must not receive Rienso: - if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primiti Rienso: - ako ste alergični (preosjetljivi) na lijek ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If this happens to you, do not drive or use any tools or machinery.
Croatian: Ako Vam se to dogodi, nemojte upravljati vozilima niti rukovati alatima ili strojevima.
English: The additional four cases were reported after this PSUR was submitted for assessment.
Croatian: Preostala četiri slučaja bila su prijavljena nakon podnošenja ovog PSUR-a na procjenu.