natgillin/translations-raw huggingface dataset:
Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test. 
Dva testa mutagenosti s natrijevim fenilbutiratom, odnosno Amesov test i mikronukleus test, bila su negativna.
AMMONAPS is prescribed to patients with urea cycle disorders. 
AMMONAPS je namijenjen bolesnicima s poremećajem ciklusa ureje.
If you are a woman who could get pregnant, you must use reliable contraception, during treatment with AMMONAPS. 
Ako ste žena u reproduktivnoj dobi, tijekom liječenja lijekom AMMONAPS morate koristiti učinkovitu kontracepciju.
Common: Rash, abnormal skin odour 
Često: osip, abnormalan miris kože
• Use the correct spoon to dispense the following amount of Ammonaps: 1.2 g = small white spoon, 3.3 g = medium sized yellow spoon and 9.7 g = large blue spoon 
• Uz pomoć odgovarajuće žlice odmjerite sljedeće količine Ammonaps granula: 1,2 g = mala bijela žlica, 3,3 g = srednja žuta žlica i 9,7 g = velika plava žlica
• Take the correct number of spoonfuls granules from the bottle 
• Iz bočice izvadite odgovarajući broj žlica granula Kod primjene kroz usta
The elimination half-life was estimated to be 1.2 and 2.4 hours, respectively. 
Procjenjuje se da poluvijek eliminacije iznosi 1,2 sata odnosno 2,4 sata.
The majority of the patients who were tested had an IQ in the average to low average/borderline mentally retarded range. 
Kvocijent inteligencije u većine se bolesnika kretao u rasponu od prosječne inteligencije do ispodprosječnih/graničnih vrijednosti mentalne retardacije.
AMMONAPS granules contain 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose. 
AMMONAPS granule sadrže 124 mg (5,4 mmol) natrija po gramu natrijeva fenilbutirata, odnosno 2,5 g (108 mmol) natrija na 20 g natrijevog fenilbutirata, što je maksimalna dnevna doza.
Frequency is defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). 
Učestalost je definirana kao vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1 000 i < 1/100); rijetko
On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion. 
Na molarnoj razini fenilacetilglutamin je usporediv s urejom (oboje sadrže po 2 mola dušika) te je stoga zamjenski nosač za izlučivanje otpadnog dušika.
Common: Decreased blood potassium, albumin, total protein and phosphate. 
Često: snižena razina kalija, albumina, ukupnog proteina i fosfata u krvi.
How to store AMMONAPS 
Kako čuvati AMMONAPS
The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively. 
Procjenjuje se da poluvijek eliminacije iznosi 1,3 sata odnosno 2,4 sata.
AMMONAPS is also available as granules for infants, children who are unable to swallow tablets and for patients with dysphagia. 
AMMONAPS je dostupan i u obliku granula za dojenčad, djecu koja ne mogu progutati tablete i bolesnike s disfagijom.
Common: Metabolic acidosis, alkalosis, decreased appetite 
Često: metabolička acidoza, alkaloza, smanjeni apetit Psihijatrijski poremećaji
Phenylbutyrate is rapidly absorbed under fasting conditions. 
Fenilbutirat se natašte brzo apsorbira.
Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys. 
Fenilacetat je metabolički aktivan spoj koji se acetilacijom spaja s glutaminom i stvara fenilacetilglutamin koji se potom izlučuje bubrezima.
Less frequent manifestations were confusion, headache, dysgeusia, hypacusis, disorientation, impaired memory and exacerbation of a pre-existing neuropathy. 
Neurotoksičnost se manje često manifestirala u obliku smetenosti, glavobolje, dizgeuzije, hipoakuzije, dezorijentiranosti, lošeg pamćenja i pogoršanja postojeće neuropatije.
AMMONAPS 500 mg tablets. 
AMMONAPS 500 mg tablete
Common: Anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis Uncommon: Aplastic anaemia, ecchymosis 
Često: anemija, trombocitopenija, leukopenija, leukocitoza, trombocitoza Manje često: aplastična anemija, ekhimoza
Affects more than 1 user in 10 
pogađa više od 1 korisnika na 10
Affects less than 1 user in 10,000 
pogađa manje od 1 korisnika na 10 000
Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/day (uncontrolled studies). 
Koncentracije fenilbutirata i njegovih metabolita u plazmi i urinu dobivene su natašte, u zdravih odraslih osoba koje su primile pojedinačnu dozu od 5 g natrijeva fenilbutirata i u bolesnika s poremećajem ciklusa ureje, hemoglobinopatijom i cirozom koji su primali pojedinačne i ponovljene oralne doze do 20 g/dan (nekontrolirana ispitivanja).
AMMONAPS tablets can get stuck in the oesophagus and cause ulcers. 
AMMONAPS tablete mogu zapeti u jednjaku i izazvati čireve.
The patient developed diarrhoea, irritability and metabolic acidosis with hypokalaemia. 
Pojavio se proljev, iritabilnost i metabolička acidoza praćena hipokalemijom.
AMMONAPS 940 mg/g granules 
AMMONAPS 940 mg/g granule
Uncommon side effects: deficiency in red blood cells due to bone marrow depression, bruising, altered heart rhythm, rectal bleeding, stomach irritation, stomach ulcer, inflammation of the pancreas. 
Manje česte nuspojave: manjak crvenih krvnih stanica zbog depresije koštane srži, modrice, promjene srčanog ritma, krvarenje iz debelog crijeva, nadražen želudac, čir želuca, upala gušterače.
Patients with a gastrostomy or nasogastric tube 
Bolesnici s gastrostomom ili nazogastričnom sondom
The mean time to peak concentration is 1 hour and the mean peak concentration 195 µg/ml. 
Srednja vrijednost vremena do postizanja vršne koncentracije iznosi 1 sat, a srednja vrijednost vršne koncentracije iznosi 195 µg/ml.
Nitrogen is a building block of proteins, because of this, there is a build up of nitrogen in the body after eating protein. 
Budući da je dušik sastavni dio proteina, nakon uzimanja proteina kroz hranu dolazi do nakupljanja dušika u tijelu.
This will give the following doses: small measure 1.2 g, medium measure 3.3 g and large measure 9.7 g of sodium phenylbutyrate. 
Na taj način dobivaju se sljedeće doze: mala žlica s 1,2 g, srednja žlica s 3,3 g i velika žlica s 9,7 g natrijeva fenilbutirata.
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. 
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.
Adverse reactions mainly involved the reproductive and gastrointestinal system. 
Nuspojave su se najčešće javljale u reproduktivnom i probavnom sustavu.
AMMONAPS tablets are off-white, oval and embossed with “UCY 500”. 
AMMONAPS tablete su gotovo bijele, ovalne tablete s otisnutom oznakom „UCY 500“.
EU/1/99/120/001 250 tablets EU/1/99/120/002 500 tablets 
EU/1/99/120/001 250 tableta EU/1/99/120/002 500 tableta
Concurrent administration of probenecid may affect renal excretion of the conjugation product of sodium phenylbutyrate. 
Istovremena primjena probenecida može utjecati na izlučivanje produkta konjugacije natrijeva fenilbutirata bubrezima.
EU/1/99/120/003 266 g granules EU/1/99/120/004 532 g granules 
EU/1/99/120/003 266 g granula EU/1/99/120/004 532 g granula
- The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica. 
- Pomoćne tvari su mikrokristalična celuloza, magnezijev stearat i koloidni, bezvodni silicijev dioksid.
EU/1/99/120/001 (250 tablets) EU/1/99/120/002 (500 tablets) 
EU/1/99/120/001 (250 tableta) EU/1/99/120/002 (500 tableta)
EU/1/99/120/003 (266 g granules) EU/1/99/120/004 (532 g granules) 
EU/1/99/120/003 (266 g granula) EU/1/99/120/004 (532 g granula)
Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate. 
Natrijev fenilbutirat je prolijek koji se brzo metabolizira u fenilacetat.
Repeated dosing with phenylacetate showed evidence of an induction of clearance. 
Ponovljene doze fenilacetata upućivale su na indukciju klirensa.
Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney. 
Poznato je da fenilbutirat oksidira u fenilacetat, koji se pomoću enzima spaja s glutaminom i tvori fenilacetilglutamin u jetri i bubrezima.
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. 
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.
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. 
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,
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. 
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.
Each AMMONAPS tablet contains 62 mg of sodium. 
Svaka tableta AMMONAPS sadrži 62 mg natrija.
Results indicate that sodium phenylbutyrate did not induce any mutagenic effects in the Ames test with or without metabolic activation. 
Rezultati Amesovog testa sa ili bez metaboličke aktivacije ukazuju na to da natrijev fenilbutirat nema mutageni učinak.
The mean time to peak concentration is 1.35 hour and the mean peak concentration 218 µg/ml. 
Srednja vrijednost vremena do postizanja vršne koncentracije iznosi 1,35 sati, a srednja vrijednost vršne koncentracije iznosi 218 µg/ml.
AMMONAPS 500 mg tablets sodium phenylbutyrate 
AMMONAPS 500 mg tablete natrijev fenilbutirat
Package leaflet: Information for the user AMMONAPS 940 mg/g granules 
Uputa o lijeku: Informacija za korisnika AMMONAPS 940 mg/g granule natrijev fenilbutirat
Three spoons (one small white spoon, one medium sized yellow spoon and one large blue spoon) are included to measure your daily dose. 
Za odmjeravanje Vaše dnevne doze priložene su tri žlice (jedna mala bijela žlica, jedna srednja žuta žlica i jedna velika plava žlica).
Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium. 
Tijekom liječenja treba pratiti razine kalija u serumu budući da izlučivanje fenilacetilglutamina bubrezima može dovesti do gubitka kalija mokraćom.
Package leaflet: Information for the user AMMONAPS 500 mg tablets 
Uputa o lijeku: Informacija za korisnika AMMONAPS 500 mg tablete natrijev fenilbutirat
AMMONAPS must be combined with a diet reduced in proteins designed especially for you by the doctor and the dietician. 
Uzimanje lijeka AMMONAPS mora pratiti režim prehrane sa smanjenim udjelom proteina koji je posebno za Vas pripremio liječnik ili nutricionist.
Do not store above 25°C. 
Ne čuvati na temperaturi iznad 25oC.
You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation. 
Osim u slučaju uspješne transplantacije jetre, tijekom cijelog ćete života morati uzimati lijekove i pridržavati se odgovarajućeg režima prehrane.
AMMONAPS granules are off-white. 
AMMONAPS granule su gotovo bijele boje.
It is recommended to use AMMONAPS granules instead. 
Umjesto tableta preporučuje se primjena AMMONAPS granula.
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. 
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.
- The other ingredients are calcium stearate and colloidal anhydrous silica. 
- Pomoćne tvari su kalcijev stearat i koloidni, bezvodni silicijev dioksid.
Affects 1 to 10 users in 100 
pogađa 1 do 10 korisnika na 100
Common: Oedema Uncommon: Arrhythmia 
Manje često: aritmija
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. 
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.
One large blue spoon of AMMONAPS granules contains 1200 mg of sodium. 
Jedna velika plava žlica AMMONAPS granula sadrži 1200 mg natrija.
One medium sized yellow spoon of AMMONAPS granules contains 408 mg of sodium. 
Jedna srednja žuta žlica AMMONAPS granula sadrži 408 mg natrija.
One small white spoon of AMMONAPS granules contains 149 mg of sodium. 
Jedna mala bijela žlica AMMONAPS granula sadrži 149 mg natrija.
Affects 1 to 10 users in 1,000 
pogađa 1 do 10 korisnika na 1000
AMMONAPS treatment should be supervised by a physician experienced in the treatment of urea cycle disorders. 
4.2 Doziranje i način primjene Liječenje AMMONAPSOM treba nadzirati liječnik s iskustvom u liječenju poremećaja ciklusa ureje.
One large spoon of AMMONAPS granules contains 1200 mg of sodium. 
Jedna velika žlica AMMONAPS granula sadrži 1200 mg natrija.
The adverse reactions are listed below, by system organ class and by frequency. 
Nuspojave su navedene u nastavku prema organskom sustavu i prema učestalosti.
Affects 1 to 10 users in 10,000 
pogađa 1 do 10 korisnika na 10 000
Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate. 
Nisu provedena ispitivanja kancerogenosti natrijeva fenilbutirata i njegovog utjecaja na plodnost.
More frequent monitoring of plasma ammonia levels is advised when these medications have to be used. 
Kad se koriste ti lijekovi, preporučuje se učestalije praćenje razine amonijaka u plazmi.
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. 
smanjeni apetit, depresija, razdražljivost, glavobolja, nesvjestica, zadržavanje tekućine (oticanje), promjene okusa (poremećaji osjeta okusa), bol u trbuhu, povraćanje, mučnina, zatvor, miris kože, osip,
One small spoon of AMMONAPS granules contains 149 mg of sodium. 
Jedna mala žlica AMMONAPS granula sadrži 149 mg natrija.
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. 
AMMONAPS uzimajte kroz usta u ravnomjerno raspoređenim dozama uz svaki obrok (primjerice tri puta dnevno).
One medium sized spoon of AMMONAPS granules contains 408 mg of sodium. 
Jedna srednja žlica AMMONAPS granula sadrži 408 mg natrija.
One gram of AMMONAPS granules contains 940 mg of sodium phenylbutyrate. 
Jedan gram AMMONAPS granula sadrži 940 mg natrijeva fenilbutirata.
Each bottle contains 250 or 500 tablets. 
250 ili 500 tableta.
Lactation 
Doziranje
1 g of granules contains 940 mg of sodium phenylbutyrate 
1 g granula sadrži 940 mg natrijeva fenilbutirata
Nutritional management: AMMONAPS must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation. 
Reguliranje prehranom: AMMONAPS se mora kombinirati s ograničenim unosom proteina iz hrane i,
Common: Abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon: Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis 
Često: bol u abdomenu, povraćanje, mučnina, opstipacija, dizgeuzija Manje često: pankreatitis, peptički čir, rektalno krvarenje, gastritis
Each tablet of AMMONAPS contains 500 mg of sodium phenylbutyrate. 
Svaka AMMONAPS tableta sadrži 500 mg natrijeva fenilbutirata.
Breast-feeding. 
Dojenje.
Each tablet contains 500 mg of sodium phenylbutyrate. 
Svaka tableta sadrži 500 mg natrijeva fenilbutirata.
AMMONAPS must be taken with a special diet reduced in protein. 
Tijekom terapije lijekom AMMONAPS morate uzimati hranu sa smanjenim udjelom proteina.
Each gram of granules contains 940 mg of sodium phenylbutyrate. 
Jedan gram granula sadrži 940 mg natrijeva fenilbutirata.
• 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg 
Uobičajena dnevna doza natrijeva fenilbutirata prema kliničkom iskustvu iznosi: • 450 - 600 mg/kg/dan za novorođenčad, dojenčad i djecu težine manje od 20 kg
Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica 
6.1 Popis pomoćnih tvari celuloza, mikrokristalična magnezijev stearat silicijev dioksid, koloidni, bezvodni
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. 
Mjerljive razine fenilbutirata u plazmi pojavljuju se 15 minuta nakon uzimanja pojedinačne oralne doze od 5 g natrijeva fenilbutirata u obliku tablete.
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. 
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.
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. 
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.
To be taken into consideration by patients on a sodium controlled diet. 
O tome trebaju voditi računa bolesnici koji moraju ograničiti unos natrija.
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. 
Mjerljive razine fenilbutirata u plazmi pojavljuju se 15 minuta nakon uzimanja pojedinačne oralne doze od 5 g natrijeva fenilbutirata u obliku granula.
• Take a heaped spoonful of granules out of the bottle 
• Iz bočice izvadite navrh punu odmjernu žlicu
Lot 
Serija
AMMONAPS is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase. 
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.
MARKETING AUTHORISATION NUMBERS 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
Calcium stearate Colloidal anhydrous silica 
6.1 Popis pomoćnih tvari kalcijev stearat silicijev dioksid, koloidni, bezvodni
The PAH can be: 
PAH može biti:
Tracleer is taken morning and evening. 
Tracleer se uzima ujutro i uvečer.
• primary (with no identified cause or inherited); 
• primaran (bez identificiranog uzroka ili nasljedan);
Similar results were seen in the second study after 24 weeks. 
Slične rezultate pokazalo je drugo ispitivanje nakon 24 tjedna.
Treatment of PAH 
Liječenje PAH-a
In the larger study patients were able to walk 44 metres further. 
U većem ispitivanju bolesnici su uspjeli prehodati 44 metra više.
The PAH seemed to remain stable in almost all of the children during the 12 or 24 weeks of treatment. 
Čini se da je PAH ostao stabilan u gotovo sve djece tijekom razdoblja liječenja u trajanju od 12 ili 24 tjedna.
This medicine overview was last updated in 10-2019. 
Pregled informacija posljednji je put ažuriran u 10. 2019.
It is available as film-coated tablets (62.5 mg; 125 mg) and as dispersible tablets (32 mg). 
Dostupan je u obliku filmom obloženih tableta (62,5 mg; 125 mg) i u obliku tableta za oralnu suspenziju (32 mg).
Patients should take the film-coated tablets with water. 
Bolesnici trebaju uzimati filmom obložene tablete s vodom.
Treatment of systemic sclerosis with digital ulcers 
Liječenje sistemske skleroze s digitalnim ulceracijama
Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the filmcoated tablets. 
Poboljšanja su također uočena u ispitivanju provedenom na 19 djece u dobi između 3 i 15 godina koja su uzimala filmom obložene tablete.
There were too few patients with class IV disease to support the use of the medicine in this group. 
Nije bilo dovoljno bolesnika s IV. stupnjem bolesti kako bi se potvrdilo korištenje lijeka u toj skupini.
Bosentan improves blood circulation and thereby, prevents the development of new digital ulcers. 
Bosentan poboljšava cirkulaciju krvi i time sprječava razvoj novih digitalnih ulceracija.
By expanding these blood vessels, pressure is reduced and symptoms are improved. 
Širenjem tih krvnih žila tlak se snižava, a simptomi se ublažavaju.
What measures are being taken to ensure the safe and effective use of Tracleer? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tracleer?
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. 
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.
‘Class II' involves slight limitation of physical activity. 
„II. stupanj ” podrazumijeva blaga ograničenja fizičke aktivnosti.
What is Tracleer and what is it used for? 
Što je Tracleer i za što se koristi?
Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Tracleer pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Other information about Tracleer 
Ostale informacije o lijeku Tracleer
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. 
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.
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. 
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.
The dispersible tablets are only for use in patients who cannot swallow the film-coated tablets. 
Tablete za oralnu suspenziju predviđene su samo za uporabu u bolesnika koji ne mogu progutati filmom obložene tablete.
The European Medicines Agency decided that Tracleer's benefits are greater than its risks and it can be authorised for use in the EU. 
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.