FrancophonIA/ELRC3.0 huggingface dataset:
English: Each AMMONAPS tablet contains 62 mg (2.7 mmol) of sodium, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Slovenian: Vsaka tableta zdravila AMMONAPS vsebuje 62 mg (2,7 mmol) natrija, kar ustreza 2,5 g (108 mmol) natrija v maksimalnem dnevnem odmerku natrijevega fenilbutirata, ki znaša 20 g. Pri predpisovanju zdravila AMMONAPS bolnikom s kongestivno odpovedjo srca, s hudimi motnjami v delovanju ledvic ali kliničnimi stanji, kjer se pojavlja zadrževanje natrija z edemi, je zato potrebna previdnost.
English: 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.
Slovenian: Občasni: pomanjkanje števila rdečih krvničk zaradi zmanjšane dejavnosti kostnega mozga, modrice, spremenjen srčni ritem, krvavitev iz danke, razdražen želodec, želodčna razjeda, vnetje trebušne slinavke.
English: • Take the correct number of spoonfuls granules from the bottle
Slovenian: • Iz plastenke vzemite pravilno število meric zrnc.
English: It is recommended to use AMMONAPS granules instead.
Slovenian: Priporočamo jemanje zdravila AMMONAPS zrnca.
English: OUTER CARTON AND BOTTLE LABEL FOR GRANULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA ŠKATLA IN NALEPKA ZA PLASTENKO ZA ZRNCA
English: EU/1/99/120/003 266 g granules EU/1/99/120/004 532 g granules
Slovenian: EU/1/99/120/003 266 g zrnc EU/1/99/120/004 532 g zrnc
English: - The other ingredients are calcium stearate and colloidal anhydrous silica.
Slovenian: − Pomožni snovi sta kalcijev stearat in brezvoden koloidni silicijev dioksid.
English: 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.
Slovenian: Zdravilo AMMONAPS zrnca vsebuje 124 mg (5,4 mmol) natrija na gram natrijevega fenilbutirata, kar ustreza 2,5 g (108 mmol) natrija v maksimalnem dnevnem odmerku natrijevega fenilbutirata, ki znaša 20 g. Pri predpisovanju zdravila AMMONAPS bolnikom s kongestivno odpovedjo srca, s hudimi motnjami v delovanju ledvic ali kliničnimi stanji, kjer se pojavlja zadrževanje natrija z edemi, je zato potrebna previdnost.
English: One medium sized spoon of AMMONAPS granules contains 408 mg of sodium.
Slovenian: Ena srednje velika žlička zdravila AMMONAPS zrnca vsebuje 408 mg natrija.
English: Common: Oedema Uncommon: Arrhythmia
Slovenian: Občasni: aritmija
English: One small white spoon of AMMONAPS granules contains 149 mg of sodium.
Slovenian: Majhna bela žlička zrnc zdravila AMMONAPS vsebuje 149 mg natrija.
English: • 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg
Slovenian: • 450 - 600 mg/kg/dan pri otrocih, ki tehtajo manj kot 20 kg • 9,9 - 13,0 g/m2/dan pri otrocih, ki tehtajo več kot 20 kg, ter pri mladostnikih in pri odraslih.
English: Common: Metabolic acidosis, alkalosis, decreased appetite
Slovenian: Občasni: aplastična anemija, ekhimoza Presnovne in prehranske motnje Pogosti: metabolična acidoza, alkaloza, zmanjšan apetit Psihiatrične motnje
English: EU/1/99/120/003 (266 g granules) EU/1/99/120/004 (532 g granules)
Slovenian: EU/1/99/120/003 (266 g zrnc) EU/1/99/120/004 (532 g zrnc)
English: One medium sized yellow spoon of AMMONAPS granules contains 408 mg of sodium.
Slovenian: Srednja rumena žlička zrnc zdravila AMMONAPS vsebuje 408 mg natrija.
English: One large spoon of AMMONAPS granules contains 1200 mg of sodium.
Slovenian: Ena velika žlička zdravila zdravila AMMONAPS zrnca vsebuje 1200 mg natrija.
English: • Shake the bottle lightly before opening
Slovenian: • Pred odmerjanjem rahlo pretresite plastenko.
English: How to store AMMONAPS
Slovenian: Shranjevanje zdravila AMMONAPS
English: One small spoon of AMMONAPS granules contains 149 mg of sodium.
Slovenian: Ena majhna žlička zdravila AMMONAPS zrnca vsebuje 149 mg natrija.
English: Package leaflet: Information for the user AMMONAPS 940 mg/g granules
Slovenian: Navodilo za uporabo AMMONAPS 940 mg/g zrnca
English: When taken by mouth
Slovenian: Če zdravilo AMMONAPS jemljete skozi usta
English: It is especially important to tell your doctor if you are taking medicines containing: - valproic acid (an antiepileptic drug), - haloperidol (used in certain psychotic disorders), - corticosteroids (cortisone-like medicines that are used to provide relief for inflamed areas of the body), - probenecid (for treatment of hyperuricemia associated with gout)
Slovenian: − kortikosteroide (kortizonu podobna zdravila za lajšanje vnetih predelov telesa) − probenecid (za zdravljenje hiperurikemije, povezane s protinom)
English: Common: Abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon: Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Slovenian: Pogosti: bolečine v trebuhu, bruhanje, navzea, zaprtost, motnje okušanja Občasni: pankreatitis, želodčni ulkus, rektalna krvavitev, gastritis
English: Each bottle contains 266 g or 532 g of granules.
Slovenian: Vsaka plastenka vsebuje 266 g ali
English: One gram of AMMONAPS granules contains 940 mg of sodium phenylbutyrate.
Slovenian: En gram zdravila AMMONAPS zrnca vsebuje 940 mg natrijevega fenilbutirata.
English: In patients diagnosed during gestation and treated prior to any episode of hyperammonaemic encephalopathy, survival was 100 %, but even in these patients, many subsequently demonstrated cognitive impairment or other neurologic deficits.
Slovenian: Toda tudi pri velikem deležu teh bolnikov so kasneje odkrili kognitivne motnje ali druge nevrološke pomanjkljivosti.
English: Each tablet of AMMONAPS contains 500 mg of sodium phenylbutyrate.
Slovenian: Vsaka tableta AMMONAPS vsebuje 500 mg natrijevega fenilbutirata.
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.
Slovenian: Povprečna najvišja koncentracija je bila za fenilacetat 48,5 µg/ml, za fenilacetilglutamin pa 68,5 µg/ml.
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.
Slovenian: Po enkratnem peroralnem odmerku 5 g natrijevega fenilbutirata v obliki tablet se merljive količine fenilbutirata v plazmi pojavijo že po 15 minutah.
English: The elimination half-life was estimated to be 1.2 and 2.4 hours, respectively.
Slovenian: Razpolovni čas izločanja je bil za fenilacetat 1,2 ure, za fenilacetilglutamin pa 2,4 ure.
English: Package leaflet: Information for the user AMMONAPS 500 mg tablets
Slovenian: Navodilo za uporabo AMMONAPS 500 mg tablete
English: Each gram of granules contains 940 mg of sodium phenylbutyrate.
Slovenian: En gram zrnc vsebuje 940 mg natrijevega fenilbutirata.
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.
Slovenian: Po enkratnem odmerku 5 g natrijevega fenilbutirata v obliki tablet, so se merljive količine fenilacetata pojavile po 30 minutah, merljive količine fenilacetilglutamina pa po 60 minutah po odmerjanju.
English: Where a patient requires administration by tube, it is possible to re-constitute AMMONAPS in water prior to use (solubility for sodium phenylbutyrate is up to 5 g in 10 ml water).
Slovenian: (topnost natrijevega fenilbutirata je do 5 g v 10 ml vode).
English: Each tablet contains 500 mg sodium phenylbutyrate.
Slovenian: Vsaka tableta vsebuje 500 mg natrijevega fenilbutirata.
English: 266 g granules
Slovenian: 266 g zrnc 532 g zrnc
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.
Slovenian: Po enkratnem peroralnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc se merljive količine fenilbutirata v plazmi pojavijo že po 15 minutah.
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.
Slovenian: Povprečni čas do najvišje koncentracije je bil za fenilacetat 3,55 ure, za fenilacetilglutamin pa 3,23 ure.
English: 1 g of granules contains 940 mg of sodium phenylbutyrate
Slovenian: 1 g zrnc vsebuje 940 mg natrijevega fenilbutirata.
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.
Slovenian: Po enkratnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc, so se merljive količine fenilacetata pojavile po 30 minutah, merljive količine fenilacetilglutamina pa po 60 minutah po odmerjanju.
English: Nervous system disorders
Slovenian: − poslabšanje obstoječih nevroloških stanj
English: Breast-feeding.
Slovenian: Dojenje.
English: AMMONAPS is also available as granules for infants, children who are unable to swallow tablets and for patients with dysphagia.
Slovenian: Za otroke, ki ne morejo požirati tablet, ter bolnike z disfagijo je zdravilo AMMONAPS na voljo tudi v obliki zrnc.
English: This medicine overview was last updated in 10-2019.
Slovenian: Pregled zdravila je bil nazadnje posodobljen 10-2019.
English: Similar results were seen in the second study after 24 weeks.
Slovenian: Podobni rezultati so bili po 24 tednih ugotovljeni tudi v drugi študiji.
English: Tracleer is taken morning and evening.
Slovenian: Zdravilo Tracleer se jemlje zjutraj in zvečer.
English: In the larger study patients were able to walk 44 metres further.
Slovenian: V večji študiji so bolniki lahko hodili 44 metrov dlje.
English: Further information on Tracleer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Tracleer so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There were too few patients with class IV disease to support the use of the medicine in this group.
Slovenian: Bolnikov z boleznijo IV. funkcijskega razreda je bilo premalo, da bi podprli uporabo tega zdravila v tej skupini.
English: It is available as film-coated tablets (62.5 mg; 125 mg) and as dispersible tablets (32 mg).
Slovenian: Na voljo je v obliki filmsko obloženih (62,5 mg, 125 mg) in disperzibilnih tablet (32 mg).
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.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Tracleer večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Tracleer?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tracleer?
English: Patients should take the film-coated tablets with water.
Slovenian: Bolniki morajo filmsko obložene tablete pogoltniti z vodo.
English: Tracleer received a marketing authorisation valid throughout the EU on 15 May 2002.
Slovenian: Za zdravilo Tracleer je bilo 15. maja 2002 izdano dovoljenje za promet, veljavno po vsej EU.
English: Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the filmcoated tablets.
Slovenian: Izboljšanje je bilo opaženo tudi v študiji pri 19 otrocih, starih od 3 do 15 let, ki so jemali filmsko obložene tablete.
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.
Slovenian: Pri odraslih je treba v prvih štirih tednih začeti z odmerkom 62,5 mg dvakrat na dan in ga nato povečati na običajni odmerek 125 mg dvakrat na dan.
English: This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma.
Slovenian: To je temeljilo na dveh študijah pri skupno 245 odraslih z boleznijo III. ali IV. funkcijskega razreda, ki je bila primarna ali povzročena s sklerodermo.
English: As for all medicines, data on the use of Tracleer are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tracleer stalno spremljajo.
English: Other information about Tracleer
Slovenian: Druge informacije o zdravilu Tracleer
English: An overview of Tracleer and why it is authorised in the EU
Slovenian: Pregled zdravila Tracleer in zakaj je odobreno v EU
English: Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Tracleer, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Tracleer have been shown in studies?
Slovenian: Kakšne koristi zdravila Tracleer so se pokazale v študijah?
English: ‘Class II' involves slight limitation of physical activity.
Slovenian: funkcijski razred pomeni blažjo omejitev telesne dejavnosti.
English: By expanding these blood vessels, pressure is reduced and symptoms are improved.
Slovenian: Z razširitvijo krvnih žil se krvni tlak zniža in simptomi izboljšajo.
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.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tracleer upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
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.
Slovenian: Učinke disperzibilnih tablet zdravila Tracleer pri otrocih so proučevali v dveh dodatnih študijah: v prvo študijo je bilo vključenih 36 otrok s pljučno arterijsko hipertenzijo, starih od 2 do 11 let, v drugo študijo pa je bilo vključenih 64 otrok s to boleznijo, starih od 3 mesecev do 11 let.
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.
Slovenian: Najpogostejši neželeni učinki zdravila Traceleer (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, zastajanje tekočine, anemija (nizke ravni hemoglobina, beljakovine v rdečih krvnih celicah, ki po telesu prenaša kisik) in nenormalni izvidi krvnih preiskav delovanja jeter.
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).
Slovenian: Zdravilo Tracleer se ne sme uporabljati pri bolnikih, ki imajo določene težave z jetri, bolnicah, ki so noseče ali bi lahko zanosile ali ki ne uporabljajo zanesljivih metod preprečevanja zanositve, in bolnikih, ki jemljejo ciklosporin A (zdravilo, ki učinkuje na imunski sistem).
English: • primary (with no identified cause or inherited);
Slovenian: • primarna (idiopatska ali podedovana);
English: For more information about using Tracleer, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Tracleer glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Why has Tracleer been approved?
Slovenian: Zakaj je bilo zdravilo Tracleer odobreno?
English: 1 year and older, the recommended starting and maintenance dose is 2 mg per kilogram body weight twice a day.
Slovenian: Pri otrocih s pljučno arterijsko hipertenzijo, starih 1 leto ali več, je priporočeni začetni in vzdrževalni odmerek 2 mg na kilogram telesne mase dvakrat na dan.
English: The second study which also looked at the effect of Tracleer on digital ulcer healing in 190 patients did not find any effect.
Slovenian: V drugi študiji, v kateri so prav tako proučevali učinek zdravila Tracleer na celjenje razjed prstov pri 190 bolnikih, se ni pokazal nikakršen učinek.
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.
Slovenian: Zdravilo Tracleer se uporablja za zdravljenje odraslih bolnikov s pljučno arterijsko hipertenzijo (PAH) III. funkcijskega razreda za izboljšanje fizične zmogljivosti (sposobnosti izvajanja telesne dejavnosti) in zmanjšanje simptomov.
English: The active substance in Tracleer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Slovenian: Učinkovina v zdravilu Tracleer, bosentan, zavira naravno prisoten hormon, imenovan endotelin-1 (ET-1), ki povzroča zožitev krvnih žil.
English: What are the risks associated with Tracleer?
Slovenian: Kakšna tveganja so povezana z zdravilom Tracleer?
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Slovenian: • posledica kongenitalnih (prirojenih) okvar srca z obvodi (nenormalnimi prehodi), ki povzročajo nenormalen pretok krvi skozi srce in pljuča.
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.
Slovenian: Podjetje, ki izdeluje zdravilo Tracleer, bo zagotovilo opozorilno kartico za bolnike glede nujnega izvajanja rednih krvnih preiskav delovanja jeter in uporabe učinkovitega kontracepcijskega sredstva za preprečitev nosečnosti.
English: What is Tracleer and what is it used for?
Slovenian: Kaj je zdravilo Tracleer in za kaj se uporablja?
English: Bosentan improves blood circulation and thereby, prevents the development of new digital ulcers.
Slovenian: Bosentan izboljša pretok krvi in s tem preprečuje nastanek novih razjed prstov.
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);
Slovenian: • posledica skleroderme (imenovane tudi sistemska skleroza, tj. bolezen, pri kateri se vezivno tkivo, ki daje oporo koži in drugim organom, nenormalno razrašča);
English: Treatment of systemic sclerosis with digital ulcers
Slovenian: Zdravljenje sistemske skleroze z razjedami prstov
English: The PAH seemed to remain stable in almost all of the children during the 12 or 24 weeks of treatment.
Slovenian: Kljub temu je pljučna arterijska hipertenzija v 12- ali 24-tedenskem obdobju zdravljenja ostala stabilna pri skoraj vseh otrocih.
English: Tracleer contains the active substance bosentan.
Slovenian: Zdravilo Tracleer vsebuje učinkovino bosentan.
English: Tracleer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes).
Slovenian: Zdravilo Tracleer se lahko uporablja tudi pri odraslih s sistemsko sklerozo, pri kateri je slab pretok krvi zaradi bolezni povzročil nastanek razjed prstov (razjed na prstih rok in nog).
English: The ‘class' reflects the severity of the disease: ‘class III' PAH involves marked limitation of physical activity.
Slovenian: Razred odraža resnost bolezni: pljučna arterijska hipertenzija III. funkcijskega razreda pomeni občutno omejitev telesne dejavnosti.
English: In PAH, severe narrowing of the blood vessels in the lungs increases blood pressure and reduces the amount of blood entering the lungs.
Slovenian: Pri pljučni arterijski hipertenziji močno zoženje krvnih žil v pljučih poveča krvni tlak in zmanjša količino krvi, ki vstopa v pljuča.
English: Tracleer can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Slovenian: Predpisovanje in izdaja zdravila Tracleer je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem pljučne arterijske hipertenzije ali sistemske skleroze.
English: Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects.
Slovenian: Podobni rezultati so bili opaženi v študiji pri 54 odraslih s pljučno arterijsko hipertenzijo III. funkcijskega razreda, povezano s prirojenimi srčnimi okvarami.
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.
Slovenian: Zdravilo Tracleer pa je po šestih mesecih zdravljenja zmanjšalo upor krvnih žil za 23 %, kar kaže na razširitev krvnih žil v primerjavi s placebom.
English: In PAH, Tracleer film-coated tablets added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.
Slovenian: Pri pljučni arterijski hipertenziji je bilo zdravilo Tracleer v obliki filmsko obloženih tablet kot dodatek k bolnikovemu trenutnemu zdravljenju po 16 tednih zdravljenja učinkovitejše od placeba (zdravila brez učinkovine) pri podaljšanju razdalje, ki jo bolniki lahko prehodijo v šestih minutah (način merjenja fizične zmogljivosti).
English: The dispersible tablets are only for use in patients who cannot swallow the film-coated tablets.
Slovenian: Disperzibilne tablete so namenjene samo za uporabo pri bolnikih, ki ne morejo pogoltniti filmsko obloženih tablet, in jih je treba pred jemanjem raztopiti v malo vode na žlici.
English: Some improvement with Tracleer can also occur in patients with class II PAH.
Slovenian: Zdravilo Tracleer lahko nekoliko izboljša stanje tudi pri bolnikih s pljučno arterijsko hipertenzijo II.
English: In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers.
Slovenian: Pri bolnikih s sistemsko sklerozo in razjedami prstov se zožijo krvne žile v prstih rok in nog, kar povzroča razjede.
English: How is Tracleer used?
Slovenian: Kako se zdravilo Tracleer uporablja?
English: Tracleer therefore prevents blood vessels from narrowing.
Slovenian: Zdravilo Tracleer torej preprečuje zožitev krvnih žil.
English: In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Tracleer and placebo groups.
Slovenian: funkcijskega razreda je bila razdalja, ki jo bolniki lahko prehodijo v šestih minutah, med skupinama, zdravljenima z zdravilom Tracleer oziroma placebom, podobna.
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.
Slovenian: po 16 tednih zdravljenja povprečno 1,4 nove razjede prstov, bolniki, ki so jemali placebo, pa 2,7 nove razjede.
English: Tracleer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults.
Slovenian: Zdravilo Tracleer se je v dveh študijah pri skupno 312 bolnikih izkazalo za učinkovitejše od placeba pri zaviranju nastajanja novih razjed prstov.
English: Tracleer is given to reduce the number of new digital ulcers.
Slovenian: Namenjeno je zmanjševanju števila novih razjed prstov.
English: How does Tracleer work?
Slovenian: Kako zdravilo Tracleer deluje?
English: The PAH can be:
Slovenian: Pljučna arterijska hipertenzija je lahko:
English: For the full list of side effects Tracleer, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tracleer, glejte navodilo za uporabo.