natgillin/translations-raw huggingface dataset:
Since the metabolism and excretion of sodium phenylbutyrate involves the liver and kidneys, AMMONAPS should be used with caution in patients with hepatic or renal insufficiency.
Ker presnova in izločanje natrijevega fenilbutirata vključuje jetra in ledvica, je potrebna previdnost pri predpisovanju zdravila AMMONAPS bolnikom z motnjami v delovanju jeter in ledvic.
Contents of the pack and other information What AMMONAPS contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo AMMONAPS
The mean time to peak concentration is 1 hour and the mean peak concentration 195 µg/ml.
Povprečni čas do najvišje koncentracije je bil 1 ura, povprečna najvišja koncentracija pa 195 µg/ml.
Take the solution immediately after mixing.
Raztopino uporabite takoj po pripravi.
Do not use AMMONAPS if you are pregnant, because this medicine can harm your unborn baby.
Ne jemljite zdravila AMMONAPS med nosečnostjo, saj lahko škoduje vašemu otroku.
AMMONAPS contains sodium
Zdravilo AMMONAPS vsebuje natrij
Studies with high intravenous doses of phenylacetate showed non linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine.
Študije z visokimi intravenskimi odmerki fenilacetata so odkrile nelinearno farmakokinetiko, katere značilnost je nasičena presnova v fenilacetilglutamin.
The significance of these data in pregnant women is not known; therefore the use of AMMONAPS is contra-indicated during pregnancy (see section 4.3).
Pomen tega pojava za nosečnice ni znan, zato je uporaba zdravila AMMONAPS v nosečnosti kontraindicirana
AMMONAPS tablets are off-white, oval and embossed with “UCY 500”.
Tablete AMMONAPS so sivo bele, ovalne in imajo vrezan napis “UCY 500”.
Increased weight.
Povečana telesna masa.
Granules.
Zrnca.
- if you are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine
- če ste noseči - če dojite če ste alergični (preobčutljivi) na natrijev fenilbutirat ali katerokoli sestavino tega zdravila
AMMONAPS must be taken with a special diet reduced in protein.
Zdravilo AMMONAPS morate jemati s posebno prehrano z zmanjšano vsebnostjo beljakovin.
AMMONAPS is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Zdravilo AMMONAPS uporabljamo kot dodatno zdravljenje pri dolgoročnem obravnavanju motenj ciklusa sečnine, ki vključujejo pomanjkljivosti karbamoilfosfat-sintaze, ornitin transkarbamoilaze ali argininosukcinat-sintaze.
Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica
Mikrokristalna celuloza Magnezijev stearat Brezvoden koloidni silicijev dioksid
Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
Med zdravljenjem je potrebno spremljati serumski kalij, ker utegne izločanje fenilacetilglutamina skozi ledvici povzročiti izgubo kalija z urinom.
What AMMONAPS looks like and contents of the pack
Izgled zdravila AMMONAPS in vsebina pakiranja
Sodium phenylbutyrate
Natrijev fenilbutirat
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.
S tem dobimo naslednje odmerke: z majhno žličko 1,2 g; s srednjo žličko 3,3 g in z veliko žličko 9,7 g natrijevega fenilbutirata.
You should take AMMONAPS in equally divided doses by mouth, through a gastrostomy (tube that goes through the abdomen to the stomach) or through a nasogastric tube (tube that goes through the nose to the stomach).
(cevko, ki gre skozi trebuh v želodec) ali nazogastrično cevko (cevko, ki gre skozi nos v želodec).
Prenatal exposure of rat pups to phenylacetate (the active metabolite of phenylbutyrate) produced lesions in cortical pyramidal cells; dendritic spines were longer and thinner than normal and reduced in number.
(aktivnemu presnovku fenilbutirata) pred rojstvom je proizvedla lezije v piramidnih kortikalnih celicah, dendriti pa so bili daljši in tanjši kot običajno, ter prisotni v manjšem številu.
The mean time to peak concentration is 1.35 hour and the mean peak concentration 218 µg/ml.
Povprečni čas do najvišje koncentracije je bil 1,35 ure, povprečna najvišja koncentracija pa 218 µg/ml.
The tablets are off-white, oval and embossed with “UCY 500”.
Tablete so sivo bele, ovalne in imajo vrezan napis “UCY 500”.
AMMONAPS is prescribed to patients with urea cycle disorders.
Zdravilo AMMONAPS se predpisuje bolnikom z motnjami v ciklusu sečnine.
In children unable to swallow tablets, it is recommended to use AMMONAPS granules instead.
Za otroke, ki ne morejo pogoltniti tablete, se priporoča uporaba zdravila AMMONAPS zrnca.
Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test.
Natrijev fenilbutirat je dal negativne rezultate v 2 preskusih mutagenosti, t.j.
• Pass a flat surface, e.g. the back of a knife blade, over the top of the spoon to remove the excess of granules
• S plosko površino (npr. rezilom noža) potegnite po žlički, da odstranite odvečno količino zrnc.
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.
Pogosti: spremembe v številu krvničk (rdečih krvničk, belih krvničk, krvnih ploščic), zmanjšan tek, depresivnost, preobčutljivost, glavobol in omedlevica, zastoj tekočin (otekanje), spremembe v okušanju (motnje okušanja), bolečine v trebuhu, bruhanje, slabost s siljenjem na bruhanje (navzea), zapeka, neprijeten telesni vonj, izpuščaj, nenormalno delovanje ledvic, zvišana telesna masa,
AMMONAPS 940 mg/g granules
AMMONAPS 940 mg/g zrnca
AMMONAPS must be combined with a diet reduced in proteins designed especially for you by the doctor and the dietician.
Zdravilo AMMONAPS se mora kombinirati s prehrano z zmanjšano vsebnostjo beljakovin, ki jo je vaš zdravnik ali dietetik prilagodil posebej za vas.
It is recommended that a heaped measuring spoon is removed from the container and a flat surface, e.g. the blade of a knife, is drawn across the top of the measure.
Priporočljivo je, da vzamemo iz plastenke zvrhano merilno žličko zdravila in nato z ravno površino (npr. rezilom noža) potegnemo po žlički in vrnemo odvečno zdravilo.
532 g granules
532 g zrnc.
EU/1/99/120/001 (250 tablets) EU/1/99/120/002 (500 tablets)
EU/1/99/120/001 (250 tablet) EU/1/99/120/002 (500 tablet)
AMMONAPS granules are off-white.
Zrnca AMMONAPS so sivo bela.
Common: Renal tubular acidosis
Bolezni sečil Pogosti: ledvična tubulna acidoza
AMMONAPS tablets can get stuck in the oesophagus and cause ulcers.
Zdravilo AMMONAPS se lahko zatakne v požiralniku in povzroči razjede.
- The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.
− Pomožne snovi so mikrokristalna celuloza, magnezijev stearat in brezvoden koloidni silicijev dioksid.
EU/1/99/120/001 250 tablets EU/1/99/120/002 500 tablets
EU/1/99/120/001 250 tablet EU/1/99/120/002 500 tablet
Pharmacotherapeutic group: various alimentary tract and metabolism products, ATC code: A16A X03.
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Različna zdravila za bolezni prebavil in presnove, oznaka ATC: A16A
Affects less than 1 user in 10,000
pojavijo se pri manj kot 1 od 10.000 bolnikov
The tablets are packaged in plastic bottles with child-resistant caps.
Tablete so pakirane v plastenke z za otroke varno zaporko.
Affects 1 to 10 users in 100
pojavijo se pri 1 do 10 od 100 bolnikov
To measure the dose:
Postopek za odmerjanje zdravila AMMONAPS:
Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Študije kancerogenosti in vpliva na sposobnost razmnoževanja niso bile izvedene z natrijevim fenilbutiratom.
- The active substance is sodium phenylbutyrate.
− Zdravilna učinkovina je natrijev fenilbutirat.
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.
Zdravilo AMMONAPS morate jemati skozi usta v enakomerno razdeljenih odmerkih z vsakim obrokom (na primer trikrat na dan).
Each AMMONAPS tablet contains 62 mg of sodium.
Vsaka tableta zdravila AMMONAPS vsebuje 62 mg natrija.
AMMONAPS tablets should not be used in patients with dysphagia due to the potential risk of oesophageal ulceration if tablets are not promptly delivered to the stomach.
Zaradi možne nevarnosti, da bi nastala ulceracija požiralnika, če tablete ne bi takoj prispele v želodec,
Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys.
Fenilacetat je presnovno dejavna spojina, ki se preko acetilacije konjugira z glutaminom v fenilacetilglutamin.
Affects 1 to 10 users in 1,000
pojavijo se pri 1 do 10 od 1.000 bolnikov
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.
Za bolnike z diagnozo neonatalnega pojava pomanjkljivosti karbamoilfosfat-sintaze je potrebno dopolnjevanje prehrane s citrulinom v odmerku 0,17 g/kg/dan oziroma pri pomanjkljivosti ornitin transkarbamoilaze pa je potrebno dopolnjevanje prehrane z argininom v odmerku 3,8 g/m2/dan.
Affects more than 1 user in 10
pojavijo se pri več kot 1 od 10 bolnikov
Micronucleus test results indicate that sodium phenylbutyrate was considered not to have produced any clastogenic effect in rats treated at toxic or non-toxic dose levels (examined 24 and 48 hours after a single oral administration of 878 to 2800 mg/kg).
Rezultati mikronukleusnega preskusa pa kažejo, da natrijev fenilbutirat ni proizvedel klastogenih učinkov pri podganah, katerim je bil dajan v toksičnih in netoksičnih odmerkih (preverjano po 24 in
OUTER CARTON AND BOTTLE LABEL FOR TABLETS
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA ŠKATLA IN NALEPKA ZA PLASTENKO ZA TABLETE
Common: Anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis Uncommon: Aplastic anaemia, ecchymosis
Pogosti: anemija, trombocitopenija, levkopenija, levkocitoza, trombocitoza
The granules are packaged in plastic bottles with child-resistant caps.
Zrnca so pakirana v plastenke z za otroke varno zaporko.
Lightly shake the bottle before dispensing.
Plastenko pred odmerjanjem rahlo pretresite.
More frequent monitoring of plasma ammonia levels is advised when these medications have to be used.
Če se dajejo ta zdravila, svetujemo pogostejše nadzorovanje plazemskih koncentracij amoniaka.
Calcium stearate Colloidal anhydrous silica
Kalcijev stearat Brezvoden koloidni silicijev dioksid
Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Natrijev fenilbutirat je predzdravilo in se hitro presnavlja v fenilacetat.
Talk to your doctor before taking AMMONAPS - if you have difficulty swallowing.
- Preden vzamete zdravilo AMMONAPS, se posvetujte z zdravnikom,če imate težave pri požiranju.
Affects 1 to 10 users in 10,000
pojavijo se pri 1 do 10 od 10.000 bolnikov
Do not store above 25°C
Shranjujte pri temperaturi do 25 °C).
One large blue spoon of AMMONAPS granules contains 1200 mg of sodium.
Velika modra žlička zrnc zdravila AMMONAPS vsebuje 1200 mg natrija.
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.
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.
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.
Občasni: pomanjkanje števila rdečih krvničk zaradi zmanjšane dejavnosti kostnega mozga, modrice, spremenjen srčni ritem, krvavitev iz danke, razdražen želodec, želodčna razjeda, vnetje trebušne slinavke.
• Take the correct number of spoonfuls granules from the bottle
• Iz plastenke vzemite pravilno število meric zrnc.
It is recommended to use AMMONAPS granules instead.
Priporočamo jemanje zdravila AMMONAPS zrnca.
OUTER CARTON AND BOTTLE LABEL FOR GRANULES
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA ŠKATLA IN NALEPKA ZA PLASTENKO ZA ZRNCA
EU/1/99/120/003 266 g granules EU/1/99/120/004 532 g granules
EU/1/99/120/003 266 g zrnc EU/1/99/120/004 532 g zrnc
- The other ingredients are calcium stearate and colloidal anhydrous silica.
− Pomožni snovi sta kalcijev stearat in brezvoden koloidni silicijev dioksid.
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.
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.
One medium sized spoon of AMMONAPS granules contains 408 mg of sodium.
Ena srednje velika žlička zdravila AMMONAPS zrnca vsebuje 408 mg natrija.
Common: Oedema Uncommon: Arrhythmia
Občasni: aritmija
One small white spoon of AMMONAPS granules contains 149 mg of sodium.
Majhna bela žlička zrnc zdravila AMMONAPS vsebuje 149 mg natrija.
• 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg
• 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.
Common: Metabolic acidosis, alkalosis, decreased appetite
Občasni: aplastična anemija, ekhimoza Presnovne in prehranske motnje Pogosti: metabolična acidoza, alkaloza, zmanjšan apetit Psihiatrične motnje
EU/1/99/120/003 (266 g granules) EU/1/99/120/004 (532 g granules)
EU/1/99/120/003 (266 g zrnc) EU/1/99/120/004 (532 g zrnc)
One medium sized yellow spoon of AMMONAPS granules contains 408 mg of sodium.
Srednja rumena žlička zrnc zdravila AMMONAPS vsebuje 408 mg natrija.
One large spoon of AMMONAPS granules contains 1200 mg of sodium.
Ena velika žlička zdravila zdravila AMMONAPS zrnca vsebuje 1200 mg natrija.
• Shake the bottle lightly before opening
• Pred odmerjanjem rahlo pretresite plastenko.
How to store AMMONAPS
Shranjevanje zdravila AMMONAPS
One small spoon of AMMONAPS granules contains 149 mg of sodium.
Ena majhna žlička zdravila AMMONAPS zrnca vsebuje 149 mg natrija.
Package leaflet: Information for the user AMMONAPS 940 mg/g granules
Navodilo za uporabo AMMONAPS 940 mg/g zrnca
When taken by mouth
Če zdravilo AMMONAPS jemljete skozi usta
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)
− kortikosteroide (kortizonu podobna zdravila za lajšanje vnetih predelov telesa) − probenecid (za zdravljenje hiperurikemije, povezane s protinom)
Common: Abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon: Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Pogosti: bolečine v trebuhu, bruhanje, navzea, zaprtost, motnje okušanja Občasni: pankreatitis, želodčni ulkus, rektalna krvavitev, gastritis
Each bottle contains 266 g or 532 g of granules.
Vsaka plastenka vsebuje 266 g ali
One gram of AMMONAPS granules contains 940 mg of sodium phenylbutyrate.
En gram zdravila AMMONAPS zrnca vsebuje 940 mg natrijevega fenilbutirata.
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.
Toda tudi pri velikem deležu teh bolnikov so kasneje odkrili kognitivne motnje ali druge nevrološke pomanjkljivosti.
Each tablet of AMMONAPS contains 500 mg of sodium phenylbutyrate.
Vsaka tableta AMMONAPS vsebuje 500 mg natrijevega 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.
Povprečna najvišja koncentracija je bila za fenilacetat 48,5 µg/ml, za fenilacetilglutamin pa 68,5 µg/ml.
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.
Po enkratnem peroralnem odmerku 5 g natrijevega fenilbutirata v obliki tablet se merljive količine fenilbutirata v plazmi pojavijo že po 15 minutah.
The elimination half-life was estimated to be 1.2 and 2.4 hours, respectively.
Razpolovni čas izločanja je bil za fenilacetat 1,2 ure, za fenilacetilglutamin pa 2,4 ure.
Package leaflet: Information for the user AMMONAPS 500 mg tablets
Navodilo za uporabo AMMONAPS 500 mg tablete
Each gram of granules contains 940 mg of sodium phenylbutyrate.
En gram zrnc vsebuje 940 mg natrijevega fenilbutirata.
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.
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.
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).
(topnost natrijevega fenilbutirata je do 5 g v 10 ml vode).
Each tablet contains 500 mg sodium phenylbutyrate.
Vsaka tableta vsebuje 500 mg natrijevega fenilbutirata.
266 g granules
266 g zrnc 532 g zrnc
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.
Po enkratnem peroralnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc se merljive količine fenilbutirata v plazmi pojavijo že po 15 minutah.
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.
Povprečni čas do najvišje koncentracije je bil za fenilacetat 3,55 ure, za fenilacetilglutamin pa 3,23 ure.
1 g of granules contains 940 mg of sodium phenylbutyrate
1 g zrnc vsebuje 940 mg natrijevega fenilbutirata.
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.
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.
Nervous system disorders
− poslabšanje obstoječih nevroloških stanj
AMMONAPS is also available as granules for infants, children who are unable to swallow tablets and for patients with dysphagia.
Za otroke, ki ne morejo požirati tablet, ter bolnike z disfagijo je zdravilo AMMONAPS na voljo tudi v obliki zrnc.
This medicine overview was last updated in 10-2019.
Pregled zdravila je bil nazadnje posodobljen 10-2019.
Similar results were seen in the second study after 24 weeks.
Podobni rezultati so bili po 24 tednih ugotovljeni tudi v drugi študiji.
Tracleer is taken morning and evening.
Zdravilo Tracleer se jemlje zjutraj in zvečer.
In the larger study patients were able to walk 44 metres further.
V večji študiji so bolniki lahko hodili 44 metrov dlje.
Further information on Tracleer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Tracleer so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
There were too few patients with class IV disease to support the use of the medicine in this group.
Bolnikov z boleznijo IV. funkcijskega razreda je bilo premalo, da bi podprli uporabo tega zdravila v tej skupini.
It is available as film-coated tablets (62.5 mg; 125 mg) and as dispersible tablets (32 mg).
Na voljo je v obliki filmsko obloženih (62,5 mg, 125 mg) in disperzibilnih tablet (32 mg).
The European Medicines Agency decided that Tracleer's benefits are greater than its risks and it can be authorised for use in the EU.
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.
What measures are being taken to ensure the safe and effective use of Tracleer?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tracleer?
Patients should take the film-coated tablets with water.
Bolniki morajo filmsko obložene tablete pogoltniti z vodo.
Tracleer received a marketing authorisation valid throughout the EU on 15 May 2002.
Za zdravilo Tracleer je bilo 15. maja 2002 izdano dovoljenje za promet, veljavno po vsej EU.
Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the filmcoated tablets.
Izboljšanje je bilo opaženo tudi v študiji pri 19 otrocih, starih od 3 do 15 let, ki so jemali filmsko obložene tablete.
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.
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.
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.
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.
As for all medicines, data on the use of Tracleer are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tracleer stalno spremljajo.
Other information about Tracleer
Druge informacije o zdravilu Tracleer
An overview of Tracleer and why it is authorised in the EU
Pregled zdravila Tracleer in zakaj je odobreno v EU
Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Tracleer, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Tracleer have been shown in studies?
Kakšne koristi zdravila Tracleer so se pokazale v študijah?
‘Class II' involves slight limitation of physical activity.
funkcijski razred pomeni blažjo omejitev telesne dejavnosti.
By expanding these blood vessels, pressure is reduced and symptoms are improved.
Z razširitvijo krvnih žil se krvni tlak zniža in simptomi izboljšajo.
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.
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.