natgillin/translations-raw huggingface dataset:
<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 (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
It is indicated in all patients with neonatal-onset disease (complete enzyme deficiencies, presenting within the first 28 days of life).
Indiciran je u svih bolesnika u kojih se znakovi bolesti pojavljuju u neonatalnoj dobi (potpuni nedostatak enzima, koji se pojavljuje unutar prvih 28 dana života).
Each carton contains one bottle.
Svaka kutija sadrži jednu bočicu.
Very common side effects (may affect more than 1 in 10 people): irregular menstrual periods and stopping of menstrual periods in fertile women.
Vrlo česte nuspojave (mogu se javiti kod 1 na 10 ljudi): nepravilni menstrualni ciklusi i prekid menstruacije u žena plodne dobi.
These rare disorders are due to a deficiency of certain liver enzymes which are necessary to eliminate waste nitrogen in the form of ammonia.
Ovi rijetki poremećaji nastaju zbog deficijencije određenih jetrenih enzima koji su neophodni za izlučivanje viška dušika u obliku amonijaka.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Bolesnici s rijetkim nasljednim poremećajima intolerancije fruktoze, malapsorpcije glukoze-galaktoze ili insuficijencijom saharaze-izomaltaze ne smiju uzimati ovaj lijek.
If persistent vomiting occurs, you should contact your doctor immediately.
Ako se pojavi neprestano povraćanje smjesta se obratite svom liječniku.
PHEBURANE will not prevent the occurrence of an acute excess of ammonia in the blood, a condition which usually constitutes a medical emergency.
PHEBURANE neće spriječiti nastup akutne prekomjerne količine amonijaka u krvi, stanja koje se obično smatra hitnim slučajem u medicini.
Pheburane is contra-indicated during pregnancy (see section 4.3).
Pheburane je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
What PHEBURANE is and what it is used for
Što je PHEBURANE i za što se koristi
You should take PHEBURANE by mouth.
PHEBURANE morate uzeti na usta.
1244 RL Ankeveen The Netherlands
1244 RL Ankeveen NIZOZEMSKA
Their cognitive performance remained relatively stable during phenylbutyrate therapy.
Kognitivne su im sposobnosti ostale relativno stabilne za vrijeme liječenja fenilbutiratom.
Women of childbearing potential must use effective contraception during treatment.
Žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije tijekom liječenja.
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.
U bolesnika kojima je dijagnoza postavljena za vrijeme gestacije i koji su liječeni prije nastupa epizode hiperamonijemijske encefalopatije, stopa preživljenja je bila 100%, ali čak i kod ovih bolesnika mnogi su pokazali kognitivna oštećenja ili druge neurološke deficite.
Common metabolic acidosis, alkalosis, decreased appetite
Često metabolička acidoza, alkaloza, smanjenje apetita
Increased weight
Porast tjelesne težine
• PHEBURANE is not recommended for the management of acute hyperammonaemia, which is a medical emergency.
• PHEBURANE se ne preporučuje za liječenje akutne hiperamonijemije, koja predstavlja medicinski hitno stanje.
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).
Temeljem mikronukleus testa smatra se da natrijev fenilbutirat nije izazvao klastogene učinke u štakorima koji su primali toksične ili netoksične doze (ispitano 24 i 48 sati nakon jednokratne peroralne primjene 878 do 2800 mg/kg).
Corticosteroids may cause the breakdown of body protein and thus increase plasma ammonia levels.
Kortikosteroidi mogu uzrokovati razgradnju tjelesnih proteina i tako povisiti razinu amonijaka u plazmi.
In clinical trials with sodium phenylbutyrate, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to sodium phenylbutyrate.
U kliničkim ispitivanjima natrijevog fenilbutirata, 56% bolesnika iskusilo je najmanje jednu nuspojavu, a za 78% tih nuspojava smatralo se da nisu povezane s natrijevim fenilbutiratom.
The usual total daily dose of sodium phenylbutyrate in clinical experience is:
Ukupna dnevna doza natrijevog fenilbutirata prema kliničkom iskustvu iznosi:
Results indicate that sodium phenylbutyrate did not induce any mutagenic effects in the Ames test with or without metabolic activation.
Rezultati ukazuju da natrijev fenilbutirat ne inducira mutagene učinke u Amesovom testu s ili bez metaboličke aktivacije.
In normal volunteers gender differences were found in the pharmacokinetic parameters of phenylbutyrate and phenylacetate (AUC and Cmax about 30 - 50 % greater in females), but not phenylacetylglutamine.
U zdravih dragovoljaca utvrđene su razlike u farmakokinetičkim parametrima fenilbutirata i fenilacetata po spolu (AUC i Cmax oko 30 - 50% više u žena), ali ne fenilacetilglutamina..
The mean time to peak concentration was 3.55 and 3.23 hours, respectively, and the mean peak concentration was 45.3 and 62.8 μg/ml, respectively.
Srednje vrijeme za postizanje vršne koncentracije u plazmi bilo je 3,55 odnosno 3,23 sati, a srednja vršna koncentracija iznosila je 45,3 odnosno 62,8 μg/ml.
There have been published reports of hyperammonaemia being induced by haloperidol and by valproate.
Objavljena su izvješća o hiperamonijemiji induciranoj haloperidolom i valproatom.
When high doses of phenylacetate (190 - 474 mg/kg) were given subcutaneously to rat pups, decreased proliferation and increased loss of neurons were observed, as well as a reduction in CNS
Kada su se visoke doze fenilacetata (190 - 474 mg/kg) primjenjivale supkutano na mladuncima štakora, uočeno je smanjenje proliferacije i povećani gubitak neurona, kao i smanjenje mijelina u SŽS-u.
This may be due to the lipophilicity of sodium phenylbutyrate and consequent differences in volume of distribution.
Razlog za ovo može biti lipofilno svojstvo natrijevog fenilbutirata i posljedična razlika u volumenu distribucije.
If you forget to take PHEBURANE
Ako ste zaboravili uzeti PHEBURANE
Plasma levels of ammonia, arginine, essential amino acids (especially branched chain amino acids), carnitine and serum proteins should be maintained within normal limits.
Razinu amonijaka, arginina, esencijalnih aminokiselina (naročito aminokiselina razgranatog lanca), karnitina u plazmi i serumskih proteina treba održavati unutar normalnih granica.
Common renal tubular acidosis
Često renalna tubularna acidoza
Common syncope, headache
Često sinkopa, glavobolja
With haemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth (but within the first month of life) increased to almost 80 % with most deaths occurring during an episode of acute hyperammonaemic encephalopathy.
S hemodijalizom, korištenjem alternativnih puteva izlučivanja suvišnog dušika (natrijev fenilbutirat, natrijev benzoat i natrijev fenilacetat), prehranom sa smanjenim unosom proteina i, u nekim slučajevima, suplementacijom esencijalnih aminokiselina stopa preživljenja novorođenčadi kojoj je dijagnoza postavljena po rođenju (ali unutar prvog mjeseca života) porasla je do gotovo 80%, a većina se smrti događa za vrijeme epizode akutne hiperamonijemijske encefalopatije.
The granules are packaged in a plastic bottle with child-resistant closure and a dessicant.
Granule su pakirane u plastičnoj bočici sa sigurnosnim zatvaračem za djecu i sredstvom za sušenje.
Summary of safety profile
Sažetak sigurnosnog profila lijeka
• Lines on the spoon indicate the amount (in gram of sodium phenylbutyrate).
Crtice na žličici označavaju količinu (u gramima natrijevog fenilbutirata).
Manifestations of neurotoxicity were predominantly somnolence, fatigue and light-headedness.
Neurotoksičnost se prvenstveno manifestirala kao somnolencija, umor i ošamućenost.
• Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary
Kucnite jedanput žličicom o stol da bi se granule poravnale vodoravno i nastavite dodavati ako je potrebno.
Because it dissolves slowly, PHEBURANE should not be administered 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).
Budući da se sporo otapa, PHEBURANE se ne smije primjenjivati kroz gastrostomu (cijev koja prolazi kroz trbuh do želuca) ili kroz nazogastričnu sondu (cijev koja ide kroz nos do želuca).
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.
Suplementacija arginina potrebna je u bolesnika s deficijencijom argininsukcinat sintetaze u dozi od 0,4 - 0,7 g/kg/dan ili 8,8 - 15,4 g/m2/dan.
If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.
Ako niste sigurni sadrže li Vaši lijekovi ove tvari provjerite to kod svog liječnika ili ljekarnika.
Therapeutic monitoring
Nadzor terapijskog učinka
Do not use PHEBURANE if you are pregnant, because this medicine can harm your unborn baby.
Trudnoća i dojenje Nemojte uzeti PHEBURANE ako ste trudni, jer ovaj lijek može naškoditi Vašem nerođenom djetetu.
It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Također je indiciran u bolesnika u kojih se znakovi bolesti pojavljuju kasnije (djelomični nedostatak enzima, koji se pojavljuje nakon prvog mjeseca života), a koji u anamnezi imaju hiperamonijemijsku encefalopatiju.
If caloric supplementation is indicated, a protein-free product is recommended.
Ako je indicirana kalorijska suplementacija, preporučuju se proizvodi koji ne sadrže bjelančevine.
A probable case of toxic reaction to sodium phenylbutyrate (450 mg/kg/d) was reported in an 18year 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 natrijev fenilbutirat (450 mg/kg/d) zabilježen je u 18-godišnje anoreksične bolesnice koja je razvila metaboličku encefalopatiju udruženu s laktacidozom, teškom hipokalijemijom, pancitopenijom, perifernom neuropatijom i pankreatitisom.
The mean time to peak concentration was 1 hour and the mean peak concentration 195 μg/ml.
Srednje vrijeme za postizanje vršne koncentracije u plazmi bilo je 1 sat, a srednja vršna koncentracija iznosila je 195 μg/ml.
The daily dose should be individually adjusted according to the patient's protein tolerance and the daily dietary protein intake needed to promote growth and development.
Dnevnu dozu treba individualno prilagoditi prema bolesnikovoj toleranciji proteina i dnevnom unosu proteina hranom potrebnom za podržavanje rasta i razvoja djeteta.
Available pharmacodynamic/toxicological data in animals have shown excretion of sodium phenylbutyrate/metabolites in milk (see section 5.3).
Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se natrijev fenilbutirat/metaboliti izlučuju u mlijeko (za detalje vidjeti dio 5.3).
• This medicinal product contains 768 mg sucrose per gram.
• Lijek sadrži 768 mg saharoze po gramu.
Do not use PHEBURANE if you are breast-feeding, because this medicine can pass into the breast milk and may harm your baby.
Nemojte uzeti PHEBURANE ako dojite, jer se ovaj lijek može izlučiti u mlijeko i tako naškoditi Vašem djetetu.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX03.
Farmakoterapijska skupina: Ostali lijekovi za probavni trakt i metabolizam, razni lijekovi za probavni trakt i metabolizam, ATK oznaka: A16AX03.
Patients with neonatal-onset disease had a high incidence of mental retardation.
Bolesnici s početkom bolesti u novorođenačkoj dobi imaju visoku incidenciju mentalne retardacije.
Nitrogen is a building block of proteins, which are an essential part of the food we eat.
Dušik je sastavni dio bjelančevina, koje su osnovni sastojak naše hrane.
PHEBURANE must be taken with a special diet reduced in protein.
PHEBURANE se mora uzimati uz posebnu dijetu s ograničenom količinom proteina.
Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Oko 80 - 100% primijenjenog lijeka izlučuje se bubrezima unutar 24 sata u obliku konjugata fenilacetilglutamina.
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 osnovi, fenilacetilglutamin se može usporediti s urejom (oboje sadrže 2 mola dušika) i stoga predstavlja alternativni vehikulum za izlučivanje suvišnog dušika.
Common anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis
Često anemija, trombocitopenija, leukopenija, leukocitoza, trombocitoza
Women of childbearing potential/Contraception in males and females Effective contraceptive measures must be taken by women of child-bearing potential.
Žene reproduktivne dobi/kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije.
Fertility There is no evidence available on the effect of sodium phenylbutyrate on fertility.
Plodnost Nema dostupnih podataka o učinku natrijevog fenilbutirata na plodnost.
The patient developed diarrhea, irritability and metabolic acidosis with hypokalaemia.
Kod bolesnika se javio proljev, razdražljivost i metabolička acidoza s hipokalijemijom.
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 (see section 4.6).
Izlaganje još nerođenih mladunaca štakora fenilacetatu (aktivnom metabolitu fenilbutirata) uzrokovalo je lezije na kortikalnim piramidalnim stanicama; dendritni trnovi bili su dulji, tanji i malobrojniji od normalnih (vidjeti dio 4.6).
In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recovered from hyperammonaemic encephalopathy and were then treated chronically with dietary protein restriction and sodium phenylbutyrate, the survival rate was 98 %.
U bolesnika s kasnim početkom deficijencije, uključujući ženske heterozigote za deficijenciju ornitin transkarbamilaze, koji su se oporavili od hiperamonijemijske encefalopatije, te su potom trajno liječeni smanjenjem proteina u prehrani i natrijevim fenilbutiratom, stopa preživljenja je bila 98 %.
What you need to know before you take PHEBURANE 3.
Što morate znati prije nego počnete uzimati PHEBURANE
This should be taken into account in patients with diabetes mellitus.
Ovo treba uzeti u obzir kod bolesnika s dijabetesom melitusom.
PHEBURANE helps the body to eliminate waste nitrogen, reducing the amount of ammonia in your body.
PHEBURANE pomaže tijelu izlučiti suvišni dušik smanjujući tako količinu amonijaka u Vašem organizmu.
Since the metabolism and excretion of sodium phenylbutyrate involves the liver and kidneys, PHEBURANE should be used with caution in patients with hepatic or renal insufficiency.
Budući da se metabolizam i izlučivanje natrijevog fenilbutirata odvija preko jetre i bubrega, PHEBURANE treba primjenjivati s oprezom u bolesnika s jetrenom ili bubrežnom insuficijencijom.
PHEBURANE may be required life-long unless orthotropic liver transplantation is elected.
Može biti potrebno uzimati PHEBURANE do kraja života ili ortotropne transplantacije jetre.
The maximum daily dose of this medicinal product is equivalent to 125% of the WHO recommended maximum daily intake for sodium.
Maksimalna dnevna doza ovog lijeka odgovara 125 % maksimalnog dnevnog unosa natrija prema preporukama SZO.
The other ingredients are: sugar spheres (sucrose and maize starch, see section 2 ‘PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Drugi sastojci su: kuglice šećera (saharoza i kukuruzni škrob, vidjeti dio 2 PHEBURANE sadrži saharozu), hipromeloza, etilceluloza N7, makrogol 1500, povidon K25.
The granules can be directly swallowed with a drink (water, fruit juices, protein-free infant formulas) or sprinkled on to a spoonful of solid foods (mashed potatoes or apple sauce).
Granule se mogu izravno progutati s pićem (voda, voćni sokovi, preparati za dojenčad koji ne sadrže proteine) ili se njima može posipati kruta hrana (pire od krumpira ili pire od jabuka) u žlici.
Common side effects (may affect more than 1 in 100 people): changes in number of blood cells (red cells, white cells and platelets), changes in the amount of bicarbonate in the blood, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), stomach ache, vomiting, nausea, constipation, abnormal skin odor, rash, abnormal kidney function, weight gain, altered laboratory test values.
Česte nuspojave (mogu se javiti kod više od 1 na 100 ljudi): promjene u broju krvnih stanica (eritrocita, leukocita i trombocita), promjene u razini bikarbonata u krvi, smanjen apetit, depresija, razdražljivost, glavobolja, padanje u nesvijest, zadržavanje tekućine (oticanje), promjena osjeta okusa, bol u želucu, povraćanje, mučnina, zatvor, neobični miris kože, osip, poremećena funkcija bubrega, dobivanje na težini, promijenjene vrijednosti laboratorijskih pretraga.
• PHEBURANE contains 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.
• PHEBURANE sadrži 124 mg (5,4 mmol) natrija po gramu natrijevog fenilbutirata, što odgovara 2,5 g (108 mmol) natrija na 20 g natrijevog fenilbutirata, što predstavlja maksimalnu dnevnu dozu.
Three cirrhotic patients (out of 6) who received repeated oral administration of sodium phenylbutyrate (20 g/day in three doses) showed sustained plasma levels of phenylacetate on the third day that were five times higher than those achieved after the first dose.
Tri bolesnika s cirozom (od 6) koji su primali ponavljane peroralne doze natrijevog fenilbutirata (20 g/dan podijeljeno u 3 doze) pokazivali su povišenu razinu fenilacetata u plazmi trećeg dana koja je bila pet puta viša od one postignute nakon prve doze.
Decreased blood potassium, albumin, total protein and phosphate.
Snižena razina kalija, albumina, ukupnih proteina i fosfata u krvi.
HDPE bottle, child-resistant closure with desiccant, containing 174 g of granules.
HDPE bočica, sigurnosni zatvarač za djecu sa sredstvom za sušenje, koja sadrži 174 g granula.
PHEBURANE treatment should be supervised by a physician experienced in the treatment of urea cycle disorders.
Liječenje PHEBURANEOM treba nadzirati liječnik koji ima iskustva u liječenju poremećaja ciklusa ureje.
Previously, neonatal-onset presentation of urea cycle disorders was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogues.
Ranije, poremećaji ciklusa ureje koji su se manifestirali u novorođenačkoj dobi gotovo uvijek su imali letalni ishod tijekom prve godine života, čak i ako su liječeni peritonejskom dijalizom i esencijalnim aminokiselinama ili njihovim analozima bez dušika.
In patients with impaired hepatic function the conversion of phenylacetate to phenylacetylglutamine may be relatively slower.
U bolesnika s oštećenom funkcijom jetara konverzija fenilacetata u fenilacetilglutamin može biti sporija.
The granules can be directly swallowed with a drink (water, fruit juices, protein-free infant formulas) or sprinkled on to a spoonful of solid foods (mashed potatoes or apple sauce); in this case, it is important that it is taken immediately in order to preserve the taste-masking.
Granule mogu biti izravno progutane s pićem (voda, voćni sokovi, pripravci za dojenčad koji ne sadrže proteine) ili njima posipati žlicu punu krute hrane (pire od krumpira, umak od jabuka); u ovom slučaju važno je da se uzme odmah kako bi se spriječilo mijenjanje okusa hrane.
Less frequent manifestations were confusion, headache, dysgeusia, hypoacusis, disorientation, impaired memory and exacerbation of a pre-existing neuropathy.
Rjeđe se manifestirala kao konfuzija, glavobolja, poremećaj osjeta okusa, hipoakuzija, dezorijentacija, slabljenje pamćenja i pogoršanje već postojeće neuropatije.
Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth.
Sazrijevanje sinapse u cerebralnom korteksu bilo je usporeno i broj funkcionalnih završetaka živaca u cerebrumu smanjen, što je rezultiralo poremećajem rasta mozga. (vidjeti dio 4.6).
Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
Povišena razina alkalne fosfataze, transaminaza, bilirubina, mokraćne kiseline, klorida, fosfata i natrija u krvi.
Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose.
Svaki gram natrijevog fenilbutirata sadrži 124 mg (5,4 mmol) natrija i 768 mg saharoze.
• 9.9 - 13.0 g/m2/day in children weighing more than 20 kg, adolescents and adults.
450 - 600 mg/kg/dan za novorođenčad, dojenčad i djecu koja teže manje od 20 kg 9,9 - 13,0 g/m2/dan za djecu koja teže više od 20 kg, adolescente i odrasle.
Uncommon aplastic anaemia, ecchymosis
Manje često aplastična anemija, ekhimoza
PHEBURANE 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.
PHEBURANE treba stoga koristiti s oprezom u bolesnika s kongestivnom insuficijencijom srca, teškom bubrežnom insuficijencijom i kliničkim stanjima u kojima postoji retencija natrija s edemima.
• This medicinal product contains 124 mg sodium per gram, equivalent to 6.2% of the WHO recommended maximum daily intake for sodium.
• Ovaj lijek sadrži 124 mg natrija po gramu, što odgovara 6,2 % maksimalnog dnevnog unosa natrija prema preporukama Svjetske zdravstvene organizacije (SZO).
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 utvrđene su u zdravih ljudi na tašte koji su primili jednokratnu dozu od 5 g natrijevog fenilbutirata, i u bolesnika s poremećajima ciklusa ureje, hemoglobinopatijama i cirozom koji su primili jednokratne i ponovljene peroralne doze od do 20 g/dan (nekontrolirana ispitivanja).
PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
6.1 Popis pomoćnih tvari kuglice šećera (saharoza i kukuruzni škrob), hipromeloza, etilceluloza N7, makrogol 1500, povidon K25.