FrancophonIA/ELRC3.0 huggingface dataset:
English: For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day.
Croatian: Kardiovaskularna prevencija Preporučena doza je 80 mg jedanput na dan.
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 40 mg tablets telmisartan
Croatian: NAZIV GOTOVOG LIJEKA Telmisartan Teva 40 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 20 mg tablets telmisartan
Croatian: NAZIV GOTOVOG LIJEKA Telmisartan Teva 20 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 80 mg tablets
Croatian: NAZIV GOTOVOG LIJEKA Telmisartan Teva 80 mg tablete
English: Teva Pharma Belgium N.V./S.A.
Croatian: Teva Pharma B.V.
English: NAME OF THE MEDICINAL PRODUCT Telmisartan Teva 20 mg tablets
Croatian: NAZIV GOTOVOG LIJEKA Telmisartan Teva 20 mg tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan Excipients with known effect:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 40 mg telmisartana.
English: OTHER
Croatian: I
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan Excipients with known effect:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 80 mg telmisartana.
English: EU/1/09/610/041 14x1 tablets EU/1/09/610/042 28x1 tablets EU/1/09/610/043 30x1 tablets EU/1/09/610/044 40x1 tablets EU/1/09/610/045 56x1 tablets EU/1/09/610/046 60x1 tablets EU/1/09/610/047 84x1 tablets EU/1/09/610/048 90x1 tablets EU/1/09/610/049 98x1 tablets EU/1/09/610/050
Croatian: EU/1/09/610/041 14x1 tableta EU/1/09/610/042 28x1 tableta EU/1/09/610/043 30x1 tableta EU/1/09/610/044 40x1 tableta EU/1/09/610/045 56x1 tableta EU/1/09/610/046 60x1 tableta EU/1/09/610/047 84x1 tableta EU/1/09/610/048 90x1 tableta EU/1/09/610/049 98x1 tableta EU/1/09/610/050
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/610/021 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/610/021 Kutije s 14x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg telmisartan Excipients with known effect:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 20 mg telmisartana.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/610/011 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/610/011 Kutije s 14x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/610/001 Cartons of 14x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/09/610/001 Kutije s 14x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Croatian: diuretici koji štede kalij (određene tablete za mokrenje), ACE-inhibitori, antagonisti receptora angiotenzina II, NSAIL (nesteroidni protuupalni lijekovi, npr. aspirin ili ibuprofen), heparin, imunosupresivi (npr. ciklosporin ili takrolimus) te antibiotik trimetoprim.
English: EU/1/09/610/051 14x1 tablets EU/1/09/610/052 28x1 tablets EU/1/09/610/053 30x1 tablets EU/1/09/610/054 40x1 tablets EU/1/09/610/055 56x1 tablets EU/1/09/610/056 60x1 tablets EU/1/09/610/057 84x1 tablets EU/1/09/610/058 90x1 tablets EU/1/09/610/059 98x1 tablets EU/1/09/610/060
Croatian: EU/1/09/610/051 14x1 tableta EU/1/09/610/052 28x1 tableta EU/1/09/610/053 30x1 tableta EU/1/09/610/054 40x1 tableta EU/1/09/610/055 56x1 tableta EU/1/09/610/056 60x1 tableta EU/1/09/610/057 84x1 tableta EU/1/09/610/058 90x1 tableta EU/1/09/610/059 98x1 tableta EU/1/09/610/060
English: EU/1/09/610/031 14x1 tablets EU/1/09/610/032 28x1 tablets EU/1/09/610/033 30x1 tablets EU/1/09/610/034 40x1 tablets EU/1/09/610/035 56x1 tablets EU/1/09/610/036 60x1 tablets EU/1/09/610/037 84x1 tablets EU/1/09/610/038 90x1 tablets EU/1/09/610/039 98x1 tablets EU/1/09/610/040 100x1 tablets
Croatian: EU/1/09/610/031 14x1 tableta EU/1/09/610/032 28x1 tableta EU/1/09/610/033 30x1 tableta EU/1/09/610/034 40x1 tableta EU/1/09/610/035 56x1 tableta EU/1/09/610/036 60x1 tableta EU/1/09/610/037 84x1 tableta EU/1/09/610/038 90x1 tableta EU/1/09/610/039 98x1 tableta EU/1/09/610/040 100x1 tableta
English: EU/1/09/610/021 14x1 tablets EU/1/09/610/022 28x1 tablets EU/1/09/610/023 30x1 tablets EU/1/09/610/024 40x1 tablets EU/1/09/610/025 56x1 tablets EU/1/09/610/026 60x1 tablets EU/1/09/610/027 84x1 tablets EU/1/09/610/028 90x1 tablets EU/1/09/610/029 98x1 tablets EU/1/09/610/030 100x1 tablets
Croatian: EU/1/09/610/021 14x1 tableta EU/1/09/610/022 28x1 tableta EU/1/09/610/023 30x1 tableta EU/1/09/610/024 40x1 tableta EU/1/09/610/025 56x1 tableta EU/1/09/610/026 60x1 tableta EU/1/09/610/027 84x1 tableta EU/1/09/610/028 90x1 tableta EU/1/09/610/029 98x1 tableta EU/1/09/610/030 100x1 tableta
English: PC: SN: NN:
Croatian: SN:
English: EU/1/09/610/011 14x1 tablets EU/1/09/610/012 28x1 tablets EU/1/09/610/013 30x1 tablets EU/1/09/610/014 40x1 tablets EU/1/09/610/015 56x1 tablets EU/1/09/610/016 60x1 tablets EU/1/09/610/017 84x1 tablets EU/1/09/610/018 90x1 tablets EU/1/09/610/019 98x1 tablets EU/1/09/610/020 100x1 tablets
Croatian: EU/1/09/610/011 14x1 tableta EU/1/09/610/012 28x1 tableta EU/1/09/610/013 30x1 tableta EU/1/09/610/014 40x1 tableta EU/1/09/610/015 56x1 tableta EU/1/09/610/016 60x1 tableta EU/1/09/610/017 84x1 tableta EU/1/09/610/018 90x1 tableta EU/1/09/610/019 98x1 tableta EU/1/09/610/020 100x1 tableta
English: EU/1/09/610/001 14x1 tablets EU/1/09/610/002 28x1 tablets EU/1/09/610/003 30x1 tablets EU/1/09/610/004 40x1 tablets EU/1/09/610/005 56x1 tablets EU/1/09/610/006 60x1 tablets EU/1/09/610/007 84x1 tablets EU/1/09/610/008 90x1 tablets EU/1/09/610/009 98x1 tablets EU/1/09/610/010 100x1 tablets
Croatian: EU/1/09/610/001 14x1 tableta EU/1/09/610/002 28x1 tableta EU/1/09/610/003 30x1 tableta EU/1/09/610/004 40x1 tableta EU/1/09/610/005 56x1 tableta EU/1/09/610/006 60x1 tableta EU/1/09/610/007 84x1 tableta EU/1/09/610/008 90x1 tableta EU/1/09/610/009 98x1 tableta EU/1/09/610/010 100x1 tableta
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, such as Telmisartan Teva.
Croatian: Prilikom upravljanja vozilima ili strojevima, povremeno može doći do pojave omaglice ili pospanosti,
English: EU/1/09/610/005 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/005 Kutije s 56x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/018 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/058 Kutije s 90x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/004 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/004 Kutije s 40x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/019 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/049 Kutije s 98x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/025 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/025 Kutije s 56x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/015 Cartons of 56x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/055 Kutije s 56x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: To be taken into account with concomitant use
Croatian: Stoga se kombinacija mora oprezno primjenjivati,
English: EU/1/09/610/014 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/041 Kutije s 14x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/009 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/009 Kutije s 98x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/007 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/007 Kutije s 84x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/003 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/003 Kutije s 30x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/006 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/006 Kutije s 60x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/026 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/026 Kutije s 60x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/017 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/047 Kutije s 84x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/008 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/008 Kutije s 90x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/013 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/053 Kutije s 30x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/029 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/029 Kutije s 98x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/010 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium aluminium blisters
Croatian: EU/1/09/610/050 Kutije s 100x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/023 Cartons of 30x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/023 Kutije s 30x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg telmisartan
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 20 mg telmisartana.
English: EU/1/09/610/016 Cartons of 60x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/056 Kutije s 60x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/028 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/028 Kutije s 90x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: Tel/Tél: +32 3 820 73 73
Croatian: Teva Pharma Belgium N.V./S.A. Tel/Tél: +32 3 820 73 73
English: EU/1/09/610/024 Cartons of 40x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/024 Kutije s 40x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/002 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/002 Kutije s 28x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/027 Cartons of 84x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/027 Kutije s 84x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: EU/1/09/610/012 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/052 Kutije s 28x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: EU/1/09/610/022 Cartons of 28x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Croatian: EU/1/09/610/032 Kutije s 28x1 tableta u aluminij-aluminij perforiranom blisteru djeljivom na jedinične doze
English: Eye disorders Rare:
Croatian: Srčani poremećaji Manje često:
English: Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to < 1/1000), and acute renal failure.
Croatian: Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti
English: EU/1/09/610/020 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium aluminium blisters
Croatian: EU/1/09/610/020 Kutije s 100x1 tableta u aluminij-aluminij perforiranom blisteru s odvojivim slojem djeljivom na jedinične doze
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 40 mg telmisartana.
English: The recommended dose of Galafold is one capsule every other day, taken by mouth at least 2 hours before or after food.
Croatian: Preporučena doza lijeka Galafold jest jedna kapsula svaki drugi dan koja se uzima oralno najmanje 2 sata prije ili nakon obroka.
English: The main measure of effectiveness was the change in patients' kidney function after 18 months of treatment.
Croatian: Glavno mjerilo učinkovitosti bila je promjena funkcije bubrega u bolesnika nakon 18 mjeseci liječenja.
English: Galafold is available as capsules (123 mg).
Croatian: Galafold je dostupan u obliku kapsula (123 mg).
English: This allows the enzyme to be transported into areas of the cell where it can break down GL-3.
Croatian: To omogućuje prijenos enzima u dijelove stanice gdje može razgraditi GL-3.
English: As a result, GL-3 cannot be broken down and it builds up in various cells in the body, including in the heart and kidneys.
Croatian: Kao rezultat toga, GL-3 se ne može razgraditi te se nakuplja u raznim stanicama u tijelu, uključujući srce i bubrege.
English: The most common side effect with Galafold (which may affect around 1 in 10 people) is headache.
Croatian: Najčešća nuspojava lijeka Galafold (može se javiti u otprilike 1 na 10 osoba) jest glavobolja.
English: Galafold has been investigated in two main studies involving a total of 127 patients with Fabry disease.
Croatian: Galafold je istraživan u dvama glavnim ispitivanjima u kojima je sudjelovalo ukupno 127 bolesnika s Fabryjevom bolešću.
English: What is Galafold and what is it used for?
Croatian: Što je Galafold i za što se koristi?
English: The Committee noted that Galafold was studied in a limited number of patients, however the available evidence is considered sufficient for such a rare disease.
Croatian: Odbor smatra da je Galafold ispitan na ograničenom broju bolesnika, međutim dostupni dokazi smatraju se dostatnima za liječenje tako rijetke bolesti.
English: This is a summary of the European public assessment report (EPAR) for Galafold.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Galafold.
English: What measures are being taken to ensure the safe and effective use of Galafold?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Galafold?
English: Why is Galafold approved?
Croatian: Zašto je Galafold odobren?
English: The second study, in 60 patients, compared Galafold with the medicines agalsidase alfa or agalsidase beta, two treatments that replace the missing enzyme.
Croatian: Druga studija provedena na 60 bolesnika uspoređivala je Galafold s lijekovima agalzidaza alfa ili agalzidaza beta, dvama liječenjima koja zamjenjuju enzim koji nedostaje.
English: The CHMP also noted that Galafold is taken by mouth and this could be an advantage compared with other authorised treatments such as enzyme replacement which are given by infusion (drip) into a vein.
Croatian: CHMP je također uočio da se Galafold uzima oralno te bi to moglo predstavljati prednost u usporedbi s drugim odobrenim liječenjima, kao što je nadomještanje enzima, koja se primjenjuju infuzijom (drip) u venu.
English: The full EPAR for Galafold can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Galafold nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the risks associated with Galafold?
Croatian: Koji su rizici povezani s lijekom Galafold?
English: Regarding safety, Galafold was well-tolerated.
Croatian: U pogledu sigurnosti, pokazalo se da se Galafold dobro podnosi.
English: Other information about Galafold
Croatian: Ostale informacije o lijeku Galafold
English: A risk management plan has been developed to ensure that Galafold is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Galafold.
English: Galafold can only be obtained with a prescription and treatment should only be started and supervised by a doctor who is experienced in the diagnosis and treatment of Fabry disease.
Croatian: Galafold se izdaje samo na liječnički recept, a liječenje bi trebao započeti i nadzirati samo liječnik iskusan u dijagnosticiranju i liječenju Fabryjeve bolesti.
English: It is not intended to provide practical advice on how to use Galafold.
Croatian: Svrha sažetka nije davati praktične savjete o načinu primjene lijeka Galafold.
English: Galafold is a medicine used to treat patients aged 16 years or over with Fabry disease.
Croatian: Galafold je lijek koji se koristi za liječenje bolesnika u dobi od 16 godina ili više koji boluju od Fabryjeve bolesti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Galafold's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Galafold nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Because the number of patients with Fabry disease is low, the disease is considered ‘rare' and Galafold was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Croatian: Budući da postoji mali broj bolesnika koji boluju od Fabryjeve bolesti, bolest se smatra „rijetkom” te se Galafold označava kao lijek za liječenje rijetkih bolesti od 22. svibnja 2006.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Galafold can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Galafold dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Overall, Galafold was not found to be more effective than placebo at reducing GL-3 deposits; however, additional analyses including only patients with those genetic mutations that can be treated with Galafold showed that patients responded better to Galafold than to placebo after 6 months of treatment.
Croatian: U cjelini, zaključeno je da Galafold nije učinkovitiji od placeba u smanjenju taloženja GL-3; međutim, dodatne analize koje su obuhvaćale samo bolesnike s onim genskim mutacijama koje se mogu liječiti lijekom Galafold pokazale su da bolesnici imaju bolju pozitivnu reakciju na Galafold nego li na placebo nakon 6 mjeseci liječenja.
English: The first study, which compared Galafold with placebo (a dummy treatment) in 67 patients, looked at the proportion of patients who responded to treatment (defined as a reduction of at least 50% in GL-3 deposits in the kidneys).
Croatian: U prvom se ispitivanju, u kojem je Galafold uspoređen s placebom (slijepo liječenje) u 67 bolesnika, promatrao udio bolesnika koji su pozitivno reagirali na liječenje (definirano kao smanjenje od najmanje 50 % u taloženju GL-3 u bubrezima).
English: This is a rare inherited disorder where patients have various mutations (changes) in the gene responsible for the production of an enzyme called alpha-galactosidase A, which normally breaks down a fatty substance called globotriaosylceramide (GL-3).
Croatian: Riječ je o rijetkom nasljednom poremećaju kod kojeg bolesnici boluju od raznih mutacija (promjena) gena odgovornog za proizvodnju enzima koji se naziva alfa-galaktozidaza A, koji obično razgrađuje masnu tvar koja se naziva globotriaozilceramid (GL-3).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Galafold, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Galafold nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: In this study, Galafold was found to be as effective as enzyme replacement in stabilising patients' kidney function.
Croatian: U tom je ispitivanju zaključeno da je Galafold jednako učinkovit kao nadomještanje enzima pri stabiliziranju funkcije bubrega u bolesnika.
English: The active substance in Galafold, migalastat, attaches to certain unstable forms of alpha-galactosidase A, stabilising the enzyme.
Croatian: Djelatna tvar u lijeku Galafold, migalastat, veže se za određene nestabilne oblike alfa-galaktozidaze A, stabilizirajući enzim.
English: In patients with Fabry disease, this enzyme does not work properly.
Croatian: Taj enzim ne radi pravilno u bolesnika s Fabryjevom bolesti.
English: Galafold contains the active substance migalastat.
Croatian: Galafold sadrži djelatnu tvar migalastat.
English: What benefits of Galafold have been shown in studies?
Croatian: Koje su koristi lijeka Galafold utvrđene u ispitivanjima?
English: For more information about treatment with Galafold, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Galafold pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Galafold is only for use in patients with certain mutations in the alpha-galactosidase A gene.
Croatian: Galafold je namijenjen samo upotrebi u bolesnika s određenim mutacijama gena alfa-galaktozidaze A.
English: How does Galafold work?
Croatian: Kako djeluje Galafold?
English: For more information, see the summary of product characteristics (also part of the EPAR).
Croatian: Više informacija potražite u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: How is Galafold used?
Croatian: Kako se Galafold koristi?
English: For practical information about using Galafold, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Galafold pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.