FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean time to peak concentration is 3.74 and 3.43 hours, respectively, and the mean peak concentration is 48.5 and 68.5 µg/ml, respectively.
Croatian: Srednja vrijednost vremena do postizanja vršne koncentracije iznosi 3,74 sata odnosno 3,43 sata, a vršna koncentracija iznosi 48,5 µg/ml odnosno 68,5 µg/ml.
English: Adverse reactions mainly involved the reproductive and gastrointestinal system.
Croatian: Nuspojave su se najčešće javljale u reproduktivnom i probavnom sustavu.
English: AMMONAPS tablets are off-white, oval and embossed with “UCY 500”.
Croatian: AMMONAPS tablete su gotovo bijele, ovalne tablete s otisnutom oznakom „UCY 500“.
English: EU/1/99/120/001 250 tablets EU/1/99/120/002 500 tablets
Croatian: EU/1/99/120/001 250 tableta EU/1/99/120/002 500 tableta
English: Concurrent administration of probenecid may affect renal excretion of the conjugation product of sodium phenylbutyrate.
Croatian: Istovremena primjena probenecida može utjecati na izlučivanje produkta konjugacije natrijeva fenilbutirata bubrezima.
English: EU/1/99/120/003 266 g granules EU/1/99/120/004 532 g granules
Croatian: EU/1/99/120/003 266 g granula EU/1/99/120/004 532 g granula
English: - The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.
Croatian: - Pomoćne tvari su mikrokristalična celuloza, magnezijev stearat i koloidni, bezvodni silicijev dioksid.
English: EU/1/99/120/001 (250 tablets) EU/1/99/120/002 (500 tablets)
Croatian: EU/1/99/120/001 (250 tableta) EU/1/99/120/002 (500 tableta)
English: EU/1/99/120/003 (266 g granules) EU/1/99/120/004 (532 g granules)
Croatian: EU/1/99/120/003 (266 g granula) EU/1/99/120/004 (532 g granula)
English: Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Croatian: Natrijev fenilbutirat je prolijek koji se brzo metabolizira u fenilacetat.
English: Repeated dosing with phenylacetate showed evidence of an induction of clearance.
Croatian: Ponovljene doze fenilacetata upućivale su na indukciju klirensa.
English: Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Croatian: Poznato je da fenilbutirat oksidira u fenilacetat, koji se pomoću enzima spaja s glutaminom i tvori fenilacetilglutamin u jetri i bubrezima.
English: AMMONAPS should therefore be used with caution in patients with congestive heart failure or severe renal insufficiency, and in clinical conditions where there is sodium retention with oedema.
Croatian: AMMONAPS stoga treba primjenjivati uz oprez u bolesnika s kongestivnim zatajenjem srca ili teškom bubrežnom insuficijencijom te u kliničkim stanjima s retencijom natrija i edemom.
English: A probable case of toxic reaction to AMMONAPS (450 mg/kg/d) was reported in an 18-year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
Croatian: Mogući slučaj toksične reakcije na AMMONAPS (450 mg/kg/d) prijavljen je u 18-godišnje anoreksične bolesnice koja je razvila metaboličku encefalopatiju povezanu s laktičnom acidozom,
English: The mean time to peak concentration is 3.55 and 3.23 hours, respectively, and the mean peak concentration is 45.3 and 62.8 µg/ml, respectively.
Croatian: Srednja vrijednost vremena do postizanja vršne koncentracije iznosi 3,55 sati odnosno 3,23 sata, a vršna koncentracija iznosi 45,3 µg/ml odnosno 62,8 µg/ml.
English: Each AMMONAPS tablet contains 62 mg of sodium.
Croatian: Svaka tableta AMMONAPS sadrži 62 mg natrija.
English: Results indicate that sodium phenylbutyrate did not induce any mutagenic effects in the Ames test with or without metabolic activation.
Croatian: Rezultati Amesovog testa sa ili bez metaboličke aktivacije ukazuju na to da natrijev fenilbutirat nema mutageni učinak.
English: The mean time to peak concentration is 1.35 hour and the mean peak concentration 218 µg/ml.
Croatian: Srednja vrijednost vremena do postizanja vršne koncentracije iznosi 1,35 sati, a srednja vrijednost vršne koncentracije iznosi 218 µg/ml.
English: AMMONAPS 500 mg tablets sodium phenylbutyrate
Croatian: AMMONAPS 500 mg tablete natrijev fenilbutirat
English: Package leaflet: Information for the user AMMONAPS 940 mg/g granules
Croatian: Uputa o lijeku: Informacija za korisnika AMMONAPS 940 mg/g granule natrijev fenilbutirat
English: Three spoons (one small white spoon, one medium sized yellow spoon and one large blue spoon) are included to measure your daily dose.
Croatian: Za odmjeravanje Vaše dnevne doze priložene su tri žlice (jedna mala bijela žlica, jedna srednja žuta žlica i jedna velika plava žlica).
English: Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
Croatian: Tijekom liječenja treba pratiti razine kalija u serumu budući da izlučivanje fenilacetilglutamina bubrezima može dovesti do gubitka kalija mokraćom.
English: Package leaflet: Information for the user AMMONAPS 500 mg tablets
Croatian: Uputa o lijeku: Informacija za korisnika AMMONAPS 500 mg tablete natrijev fenilbutirat
English: AMMONAPS must be combined with a diet reduced in proteins designed especially for you by the doctor and the dietician.
Croatian: Uzimanje lijeka AMMONAPS mora pratiti režim prehrane sa smanjenim udjelom proteina koji je posebno za Vas pripremio liječnik ili nutricionist.
English: Do not store above 25°C.
Croatian: Ne čuvati na temperaturi iznad 25oC.
English: You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation.
Croatian: Osim u slučaju uspješne transplantacije jetre, tijekom cijelog ćete života morati uzimati lijekove i pridržavati se odgovarajućeg režima prehrane.
English: AMMONAPS granules are off-white.
Croatian: AMMONAPS granule su gotovo bijele boje.
English: It is recommended to use AMMONAPS granules instead.
Croatian: Umjesto tableta preporučuje se primjena AMMONAPS granula.
English: Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day.
Croatian: Nadomjestke citrulina ili arginina u dozi od 0,17 g/kg/dan ili 3,8 g/m2/dan moraju uzimati bolesnici kojima je nedostatak karbamil-fosfat sintetaze ili ornitin transkarbamilaze dijagnosticiran u neonatalnoj dobi.
English: - The other ingredients are calcium stearate and colloidal anhydrous silica.
Croatian: - Pomoćne tvari su kalcijev stearat i koloidni, bezvodni silicijev dioksid.
English: Affects 1 to 10 users in 100
Croatian: pogađa 1 do 10 korisnika na 100
English: Common: Oedema Uncommon: Arrhythmia
Croatian: Manje često: aritmija
English: Arginine supplementation is required for patients diagnosed with deficiency of argininosuccinate synthetase at a dose of 0.4 - 0.7 g/kg/day or 8.8 - 15.4 g/m2/day.
Croatian: Nadomjestke arginina u dozi 0,4 - 0,7 g/kg/dan ili 8,8 - 15,4 g/m2/dan moraju uzimati bolesnici kojima je dijagnosticiran nedostatak arginosukcinat sintetaze.
English: One large blue spoon of AMMONAPS granules contains 1200 mg of sodium.
Croatian: Jedna velika plava žlica AMMONAPS granula sadrži 1200 mg natrija.
English: One medium sized yellow spoon of AMMONAPS granules contains 408 mg of sodium.
Croatian: Jedna srednja žuta žlica AMMONAPS granula sadrži 408 mg natrija.
English: One small white spoon of AMMONAPS granules contains 149 mg of sodium.
Croatian: Jedna mala bijela žlica AMMONAPS granula sadrži 149 mg natrija.
English: Affects 1 to 10 users in 1,000
Croatian: pogađa 1 do 10 korisnika na 1000
English: AMMONAPS treatment should be supervised by a physician experienced in the treatment of urea cycle disorders.
Croatian: 4.2 Doziranje i način primjene Liječenje AMMONAPSOM treba nadzirati liječnik s iskustvom u liječenju poremećaja ciklusa ureje.
English: One large spoon of AMMONAPS granules contains 1200 mg of sodium.
Croatian: Jedna velika žlica AMMONAPS granula sadrži 1200 mg natrija.
English: The adverse reactions are listed below, by system organ class and by frequency.
Croatian: Nuspojave su navedene u nastavku prema organskom sustavu i prema učestalosti.
English: Affects 1 to 10 users in 10,000
Croatian: pogađa 1 do 10 korisnika na 10 000
English: Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Croatian: Nisu provedena ispitivanja kancerogenosti natrijeva fenilbutirata i njegovog utjecaja na plodnost.
English: More frequent monitoring of plasma ammonia levels is advised when these medications have to be used.
Croatian: Kad se koriste ti lijekovi, preporučuje se učestalije praćenje razine amonijaka u plazmi.
English: Common side effects: changes in number of blood cells (red cells, white cells and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances),pain in the abdomen, vomiting, nausea, constipation, skin odour, rash, abnormal kidney function, weight gain, altered laboratory test values.
Croatian: smanjeni apetit, depresija, razdražljivost, glavobolja, nesvjestica, zadržavanje tekućine (oticanje), promjene okusa (poremećaji osjeta okusa), bol u trbuhu, povraćanje, mučnina, zatvor, miris kože, osip,
English: One small spoon of AMMONAPS granules contains 149 mg of sodium.
Croatian: Jedna mala žlica AMMONAPS granula sadrži 149 mg natrija.
English: You should take AMMONAPS by mouth in equally divided doses with each meal (for example three times per day).You should take AMMONAPS with a large volume of water.
Croatian: AMMONAPS uzimajte kroz usta u ravnomjerno raspoređenim dozama uz svaki obrok (primjerice tri puta dnevno).
English: One medium sized spoon of AMMONAPS granules contains 408 mg of sodium.
Croatian: Jedna srednja žlica AMMONAPS granula sadrži 408 mg natrija.
English: One gram of AMMONAPS granules contains 940 mg of sodium phenylbutyrate.
Croatian: Jedan gram AMMONAPS granula sadrži 940 mg natrijeva fenilbutirata.
English: Each bottle contains 250 or 500 tablets.
Croatian: 250 ili 500 tableta.
English: Lactation
Croatian: Doziranje
English: 1 g of granules contains 940 mg of sodium phenylbutyrate
Croatian: 1 g granula sadrži 940 mg natrijeva fenilbutirata
English: Nutritional management: AMMONAPS must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation.
Croatian: Reguliranje prehranom: AMMONAPS se mora kombinirati s ograničenim unosom proteina iz hrane i,
English: Common: Abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon: Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Croatian: Često: bol u abdomenu, povraćanje, mučnina, opstipacija, dizgeuzija Manje često: pankreatitis, peptički čir, rektalno krvarenje, gastritis
English: Each tablet of AMMONAPS contains 500 mg of sodium phenylbutyrate.
Croatian: Svaka AMMONAPS tableta sadrži 500 mg natrijeva fenilbutirata.
English: Breast-feeding.
Croatian: Dojenje.
English: Each tablet contains 500 mg of sodium phenylbutyrate.
Croatian: Svaka tableta sadrži 500 mg natrijeva fenilbutirata.
English: AMMONAPS must be taken with a special diet reduced in protein.
Croatian: Tijekom terapije lijekom AMMONAPS morate uzimati hranu sa smanjenim udjelom proteina.
English: Each gram of granules contains 940 mg of sodium phenylbutyrate.
Croatian: Jedan gram granula sadrži 940 mg natrijeva fenilbutirata.
English: • 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg
Croatian: Uobičajena dnevna doza natrijeva fenilbutirata prema kliničkom iskustvu iznosi: • 450 - 600 mg/kg/dan za novorođenčad, dojenčad i djecu težine manje od 20 kg
English: Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica
Croatian: 6.1 Popis pomoćnih tvari celuloza, mikrokristalična magnezijev stearat silicijev dioksid, koloidni, bezvodni
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylbutyrate are detected 15 minutes after dosing.
Croatian: Mjerljive razine fenilbutirata u plazmi pojavljuju se 15 minuta nakon uzimanja pojedinačne oralne doze od 5 g natrijeva fenilbutirata u obliku tablete.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylacetate and phenylacetylglutamine are detected 30 and 60 minutes respectively after dosing.
Croatian: Mjerljive razine fenilacetata i fenilacetilglutamina u plazmi pojavljuju se 30, odnosno 60 minuta nakon uzimanja pojedinačne oralne doze od 5 g natrijeva fenilbutirata u obliku tablete.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine are detected 30 and 60 minutes respectively after dosing.
Croatian: Mjerljive razine fenilacetata i fenilacetilglutamina u plazmi pojavljuju se 30 odnosno 60 minuta nakon uzimanja pojedinačne oralne doze od 5 g natrijeva fenilbutirata u obliku granula.
English: To be taken into consideration by patients on a sodium controlled diet.
Croatian: O tome trebaju voditi računa bolesnici koji moraju ograničiti unos natrija.
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate are detected 15 minutes after dosing.
Croatian: Mjerljive razine fenilbutirata u plazmi pojavljuju se 15 minuta nakon uzimanja pojedinačne oralne doze od 5 g natrijeva fenilbutirata u obliku granula.
English: • Take a heaped spoonful of granules out of the bottle
Croatian: • Iz bočice izvadite navrh punu odmjernu žlicu
English: Lot
Croatian: Serija
English: AMMONAPS is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Croatian: AMMONAPS stoga treba primjenjivati uz oprez u bolesnika s kongestivnom zatajenjem srca ili teškom bubrežnom insuficijencijom te u kliničkim stanjima s retencijom natrija i edemom.
English: MARKETING AUTHORISATION NUMBERS
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Calcium stearate Colloidal anhydrous silica
Croatian: 6.1 Popis pomoćnih tvari kalcijev stearat silicijev dioksid, koloidni, bezvodni
English: The PAH can be:
Croatian: PAH može biti:
English: Tracleer is taken morning and evening.
Croatian: Tracleer se uzima ujutro i uvečer.
English: • primary (with no identified cause or inherited);
Croatian: • primaran (bez identificiranog uzroka ili nasljedan);
English: Similar results were seen in the second study after 24 weeks.
Croatian: Slične rezultate pokazalo je drugo ispitivanje nakon 24 tjedna.
English: Treatment of PAH
Croatian: Liječenje PAH-a
English: In the larger study patients were able to walk 44 metres further.
Croatian: U većem ispitivanju bolesnici su uspjeli prehodati 44 metra više.
English: The PAH seemed to remain stable in almost all of the children during the 12 or 24 weeks of treatment.
Croatian: Čini se da je PAH ostao stabilan u gotovo sve djece tijekom razdoblja liječenja u trajanju od 12 ili 24 tjedna.
English: This medicine overview was last updated in 10-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 10. 2019.
English: It is available as film-coated tablets (62.5 mg; 125 mg) and as dispersible tablets (32 mg).
Croatian: Dostupan je u obliku filmom obloženih tableta (62,5 mg; 125 mg) i u obliku tableta za oralnu suspenziju (32 mg).
English: Patients should take the film-coated tablets with water.
Croatian: Bolesnici trebaju uzimati filmom obložene tablete s vodom.
English: Treatment of systemic sclerosis with digital ulcers
Croatian: Liječenje sistemske skleroze s digitalnim ulceracijama
English: Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the filmcoated tablets.
Croatian: Poboljšanja su također uočena u ispitivanju provedenom na 19 djece u dobi između 3 i 15 godina koja su uzimala filmom obložene tablete.
English: There were too few patients with class IV disease to support the use of the medicine in this group.
Croatian: Nije bilo dovoljno bolesnika s IV. stupnjem bolesti kako bi se potvrdilo korištenje lijeka u toj skupini.
English: Bosentan improves blood circulation and thereby, prevents the development of new digital ulcers.
Croatian: Bosentan poboljšava cirkulaciju krvi i time sprječava razvoj novih digitalnih ulceracija.
English: By expanding these blood vessels, pressure is reduced and symptoms are improved.
Croatian: Širenjem tih krvnih žila tlak se snižava, a simptomi se ublažavaju.
English: What measures are being taken to ensure the safe and effective use of Tracleer?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tracleer?
English: In adults, it should be started at a dose of 62.5 mg twice a day for four weeks and then increased to the usual dose of 125 mg twice a day.
Croatian: Terapiju u odraslih osoba treba započeti s dozom od 62,5 mg dva puta na dan tijekom četiri tjedna te zatim povećati na uobičajenu dozu od 125 mg dva puta na dan.
English: ‘Class II' involves slight limitation of physical activity.
Croatian: „II. stupanj ” podrazumijeva blaga ograničenja fizičke aktivnosti.
English: What is Tracleer and what is it used for?
Croatian: Što je Tracleer i za što se koristi?
English: Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Tracleer pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Tracleer
Croatian: Ostale informacije o lijeku Tracleer
English: In the first study, patients taking Tracleer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo.
Croatian: U prvom ispitivanju bolesnici koji su uzimali Tracleer imali su prosječno 1,4 nove digitalne ulceracije nakon 16 tjedana, u usporedbi s 2,7 u bolesnika koji su uzimali placebo.
English: Two additional studies looked at the effects of Tracleer dispersible tablets in children: the first study included 36 children with PAH aged between 2 and 11 years, while the second study included 64 children with PAH aged from 3 months up to 11 years.
Croatian: Dva dodatna ispitivanja istražila su djelovanje tableta za oralnu suspenziju lijeka Tracleer u djece: prvo ispitivanje obuhvatilo je 36 djece s PAH-om u dobi između dvije i 11 godina, dok je drugo ispitivanje obuhvatilo 64 djece s PAH-om u dobi između tri mjeseca i 11 godina starosti.
English: The dispersible tablets are only for use in patients who cannot swallow the film-coated tablets.
Croatian: Tablete za oralnu suspenziju predviđene su samo za uporabu u bolesnika koji ne mogu progutati filmom obložene tablete.
English: The European Medicines Agency decided that Tracleer's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Tracleer nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: An overview of Tracleer and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Tracleer i zašto je odobren u EU-u
English: Further information on Tracleer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Lijek Tracleer dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 15. svibnja 2002. Više informacija o lijeku Tracleer dostupno je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tracleer have also 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 Tracleer nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: However, Tracleer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.
Croatian: Međutim, lijek Tracleer smanjio je otpor krvnih žila za 23 %, što ukazuje na proširenje krvnih žila, u usporedbi s placebom nakon šest mjeseci liječenja.
English: Some improvement with Tracleer can also occur in patients with class II PAH.
Croatian: Određena poboljšanja s primjenom lijeka Tracleer mogu se pojaviti i u bolesnika s PAH-om II. stupnja.
English: The company that makes Tracleer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.
Croatian: Tvrtka koja proizvodi lijek Tracleer osigurat će bolesnicima karticu s upozorenjima kako bi ih podsjetila na potrebu redovitih krvnih pretraga funkcije jetre i korištenja učinkovitih kontracepcijskih sredstava u svrhu izbjegavanja trudnoće.
English: As for all medicines, data on the use of Tracleer are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Tracleer kontinuirano se prate.
English: Tracleer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system).
Croatian: Tracleer se ne smije koristiti u bolesnika koji imaju određene probleme u funkciji jetre, u trudnica ili žena reproduktivne dobi koje ne koriste pouzdane kontracepcijske metode ili koje uzimaju ciklosporin (lijek koji djeluje na imunosni sustav).
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Croatian: • uzrokovan sklerodermom (naziva se i sistemska skleroza, bolest abnormalnog rasta vezivnoga tkiva koje podržava kožu i ostale organe);
English: The most common side effects with Tracleer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver.
Croatian: Najčešće nuspojave lijeka Tracleer (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, zadržavanje tekućine, anemija (niske razine hemoglobina, proteina u crvenim krvnim stanicama koji prenosi kisik u tijelu) i abnormalni rezultati krvnih pretraga za provjeru funkcije jetre.
English: 1 year and older, the recommended starting and maintenance dose is 2 mg per kilogram body weight twice a day.
Croatian: U djece s PAH-om u dobi od godine dana i starijih, preporučena je početna doza i doza održavanja od 2 mg po kilogramu tjelesne težine dva puta na dan.
English: Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects.
Croatian: Slični su rezultati uočeni u ispitivanju provedenom na 54 odrasle osobe sa PAH-om III. stupnja koji je bio povezan s kongenitalnim srčanim manama.
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Croatian: • uzrokovan kongenitalnim (urođenim) srčanim manama sa šantovima (abnormalni prolazi) koje uzrokuju abnormalan protok krvi kroz srce i pluća.
English: Tracleer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms.
Croatian: Tracleer se koristi za liječenje bolesnika s plućnom arterijskom hipertenzijom (PAH) III. stupnja kako bi se poboljšao kapacitet fizičkog opterećenja (sposobnost izvođenja fizičke aktivnosti) i ublažili simptomi.
English: What are the risks associated with Tracleer?
Croatian: Koji su rizici povezani s lijekom Tracleer?