natgillin/translations-raw huggingface dataset:
It is not known whether sapropterin or its metabolites are excreted in human breast milk.
Ni znano, ali se sapropterin ali njegovi presnovki izločajo v materino mleko.
This medicine is also used to treat an inherited disease called BH4 deficiency in patients of all ages, in which the body cannot produce enough BH4.
To zdravilo se uporablja tudi za zdravljenje dedne bolezni, imenovane pomanjkanje BH4, pri bolnikih vseh starosti, pri kateri telo ne more tvoriti dovolj BH4.
Small particles may be visible in the solution, but they will not affect the effectiveness of the medicine.
V raztopini lahko ostanejo vidni majhni delci, ki ne bodo vplivali na učinkovitost zdravila.
Do not swallow the tube or the contents.
Cevke ali vsebine ne smete pogoltniti.
In preclinical studies, no effects of sapropterin on male and female fertility were observed.
V predkliničnih študijah niso opazili učinkov sapropterina na plodnost pri moških in ženskah.
Other medicines and Kuvan
Druga zdravila in zdravilo Kuvan
• If your doctor told you to administer only a portion of the solution, point the tip of the oral syringe into the medicine cup.
• Če vam je zdravnik povedal, da dajte le del raztopine, usmerite konico brizge za peroralno dajanje v merico za zdravilo.
Although concomitant administration of inhibitors of dihydrofolate reductase (e.g. methotrexate, trimethoprim) has not been studied, such medicinal products may interfere with BH4 metabolism.
Čeprav sočasnega jemanja zaviralcev dihidrofolat reduktaze (npr. metotreksat, trimetoprim) niso preučevali, pa ta zdravila lahko vplivajo na presnovo BH4.
This leaflet was last revised in month/YYYY Other sources of information
Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Drugi viri informacij
The bottles are sealed with an aluminium seal.
Plastenke so zapečatene z aluminijasto zaporko.
If you have red, itchy, raised areas (hives), runny nose, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing, serious difficulty in breathing or dizziness, you may be having a serious allergic reaction to the medicine.
Če imate rdeča, srbeča ali izbočena območja (koprivnico), vam teče iz nosu, hitro ali neenakomerno bije srce, imate otekel jezik ali grlo, kihate, sopete, imate hude težave pri dihanju ali ste omotični, imate lahko hudo alergijsko reakcijo na zdravilo.
Emesis has been observed in both the safety pharmacology and the repeated-dose toxicity studies.
Bruhanje so opažali tako v raziskavah farmakologije varnosti kot v raziskavah toksičnosti ponavljajočih odmerkov.
Check to make sure that the amount of liquid lines up with the amount that your doctor tells you.
Prepričajte se, da se količina tekočine ujema s količino, ki vam jo pove zdravnik.
Excretion of total biopterin in milk was demonstrated in rats by intravenous route.
Izločanje celokupnega biopterina v mleko so pri podganah dokazali po intravenskem dajanju.
Frequency, type and severity of adverse reactions in children were essentially similar to those in adults.
Pediatrična populacija Pogostnost, vrsta in resnost neželenih učinkov pri otrocih so bili bistveno podobni kot pri odraslih.
BH4 is a cofactor for nitric oxide synthetase.
BH4 je kofaktor encima dušikov oksid sintetaza.
Dosing for BH4 deficiency
Odmerjanje pri pomanjkanju BH4
If only a portion of this solution needs to be administered, an oral syringe should be used to withdraw the volume of solution to be administered.
Če je treba dati le del te raztopine za uporabo, je treba uporabiti brizgo za peroralno dajanje, da se odvzame potrebni volumen raztopine za uporabo.
If you are not able to give your child's dose within 30 minutes after dissolving the powder, you will need to prepare a new solution as the unused solution should not be used beyond 30 minutes.
Če otroku odmerka ne morete dati v 30 minutah po raztopitvi praška, boste morali pripraviti novo raztopino, saj se neuporabljene raztopine po 30 minutah ne sme več uporabiti.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX07
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16AX07
Date of the first authorisation: 02 December 2008 Date of latest renewal: 02 December 2013
Datum zadnjega podaljšanja: 02. december 2013.
In both cases, phenylalanine cannot be effectively transformed into the amino acid tyrosine, leading to increased phenylalanine levels in the blood.
V obeh primerih se fenilalanin ne more učinkovito pretvoriti v aminokislino tirozin, kar vodi do zvišanih ravni fenilalanina v krvi.
Supplies needed to prepare and give your child's dose of Kuvan
Potrebščine, potrebne za pripravo in dajanje odmerka zdravila Kuvan otroku
A satisfactory response is defined as a ≥30 percent reduction in blood phenylalanine levels or attainment of the therapeutic blood phenylalanine goals defined for an individual patient by the treating physician.
Zadovoljiv odziv je definiran kot ≥ 30 odstotno znižanje ravni fenilalanina v krvi ali doseganje ciljne terapevtske vrednosti ravni fenilalanina v krvi, ki jih je za posameznega bolnika določil zdravnik.
Treatment with Kuvan must be initiated and supervised by a physician experienced in the treatment of PKU and BH4 deficiency.
Zdravljenje z zdravilom Kuvan mora vpeljati in nadzorovati zdravnik z izkušnjami na področju zdravljenja PKU in pomanjkanja BH4.
Prolonged exposure to low blood phenylalanine and tyrosine levels during infancy has been associated with impaired neurodevelopmental outcome.
Dolgotrajno izpostavljenost nizkim ravnem fenilalanina in tirozina v krvi v obdobju otroštva so povezali z nepravilnostmi v razvoju živčevja.
Important information about some of the ingredients of Kuvan
Pomembne informacije o nekaterih sestavinah zdravila Kuvan
If maternal phenylalanine levels are not strictly controlled before and during pregnancy, this could be harmful to the mother and the foetus.
Če ravni fenilalanina pri materi niso strogo nadzorovane pred in med nosečnostjo, je to lahko škodljivo tako za mater kot za plod.
What you need to know before you take Kuvan Do not take Kuvan
Kaj morate vedeti, preden boste vzeli zdravilo Kuvan Ne jemljite zdravila Kuvan
Sapropterin dihydrochloride is primarily metabolised in the liver to dihydrobiopterin and biopterin.
Sapropterinijev diklorid se primarno presnavlja v jetrih in sicer v dihidrobiopterin in biopterin.
HPA and PKU are due to abnormally high levels of phenylalanine in the blood which can be harmful.
HPA in PKU nastaneta zaradi nenormalno visokih ravni fenilalanina v krvi, ki so lahko škodljive.
If you are not able to give your child's dose within 15 to 20 minutes after dissolving the tablets, you will need to prepare a new solution as the unused solution should not be used beyond 20 minutes.
Če otroku odmerka ne morete dati v 15 do 20 minutah po raztopitvi tablet, boste morali pripraviti novo raztopino, saj se neuporabljene raztopine po 20 minutah ne sme več uporabiti.
If the strict diet does not adequately reduce phenylalanine amount in your blood your doctor will consider whether you must take this medicine.
Če se s strogo dieto raven fenilalanina v krvi ne zniža ustrezno, bo zdravnik premislil, ali morate uporabljati to zdravilo.
If you stop taking Kuvan
Če ste prenehali jemati zdravilo Kuvan
Single-use sachets.
Vrečica za enkratno uporabo.
Clinical efficacy
Klinična učinkovitost in varnost
• Throw away any remaining solution.
• Preostalo raztopino zavrzite.
The Phase III clinical development program for Kuvan included 2, randomised placebo-controlled studies in patients with PKU.
Faza III načrta kliničnega razvoja zdravila Kuvan je obsegala dve randomizirani, s placebom nadzorovani študiji pri bolnikih s PKU.
The solution should be consumed within 30 minutes of initial dissolution.
Raztopino je treba zaužiti v 30 minutah po prvotni raztopitvi.
Not known side effects (frequency cannot be estimated from the available data) Gastritis (inflammation of the lining of the stomach), oesophagitis (inflammation of the lining of the gullet).
Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) gastritis (vnetje želodčne sluznice), ezofagitis (vnetje sluznice požiralnika).
Since sapropterin dihydrochloride is a synthetic version of the naturally occurring 6R-BH4, it can be reasonably anticipated to undergo the same metabolism, including 6R-BH4 regeneration.
Ker je sapropterinijev diklorid sintezna oblika naravnega 6R-BH4, je mogoče pričakovati, da bo njegovo presnavljanje potekalo enako, vključno z 6R-BH4 regeneracijo.
This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
To morajo upoštevati bolniki, ki imajo zmanjšano delovanje ledvic, ali bolniki, ki so na dieti z nadzorovanim vnosom kalija.
Draw up the prescribed volume from the solution prepared in the medicine cup and place the tip of the oral syringe into your baby's mouth.
Izvlecite predpisan volumen pripravljene raztopine v merico za zdravilo in dajte konico brizge za peroralno dajanje v dojenčkova usta.
The safety, efficacy and population pharmacokinetics of Kuvan were studied in a multicentre, openlabel, randomised, controlled study in children <4 years old with a confirmed diagnosis of PKU.
Varnost, učinkovitost in populacijsko farmakokinetiko zdravila Kuvan so preučili v multicentrični, odprti, randomizirani, nadzorovani študiji pri otrocih, starih < 4 leta, s potrjeno diagnozo PKU.
There are limited amount of data from the use of Kuvan in pregnant women.
Podatki o uporabi zdravila Kuvan pri nosečnicah so omejeni.
Kuvan should not be used during breast-feeding.
Zdravilo Kuvan se med dojenjem ne sme uporabljati.
A calculated dose of 451 mg to 499 mg should be rounded up to 500 mg corresponding to 5 tablets.
Izračunani dnevni odmerek od 451 mg do 499 mg je potrebno zaokrožiti navzgor na 500 mg, kar ustreza odmerku 5 tablet.
No tumorigenic activity was observed in an oral carcinogenicity study in mice at doses of up to 250 mg/kg/day (12.5 to 50 times the human therapeutic dose range).
Nikakršne tumorogene aktivnosti niso ugotovili v raziskavi karcinogenosti po peroralnem dajanju odmerkov do 250 mg/kg/dan pri miših (12,5 do 50-kratnik terapevtskega odmerka za ljudi).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT DRUGI PODATKI
In non-clinical studies, sapropterin was primarily distributed to the kidneys, adrenal glands, and liver as assessed by levels of total and reduced biopterin concentrations.
V predkliničnih raziskavah se je sapropterin porazdeljeval pretežno v ledvice, nadledvični žlezi in jetra, kot so ocenjevali z vrednostmi skupnih in znižanih koncentracij biopterina.
Doses may be adjusted up to a total of 20 mg/kg per day.
Odmerek bo morda treba prilagoditi do skupno največ 20 mg/kg na dan.
Polyethylene terephthalate, aluminum, polyethylene laminate sachet, heat sealed on four sides.
Laminirana vrečica iz polietilen tereftalata, aluminija in polietilena, toplotno zavarjena na vseh štirih straneh.
Unused solution should be discarded after administration.
Neporabljeno raztopino je treba po uporabi zavreči.
A higher intestinal concentration of Kuvan is needed to inhibit BCRP than P-gp, as inhibitory potency in intestine for BCRP (IC50=267 µM) is lower than P-gp (IC50=158 µM).
Za zaviranje proteina BCRP je v črevesju potrebna višja koncentracija zdravila Kuvan kot za zaviranje p-glikoproteina, saj je zmožnost zaviranja v črevesju za BCRP (IC50=267 µM) nižja kot za P-gp (IC50=158 µM).
If an unsatisfactory reduction in blood phenylalanine levels is observed, then the dose can be increased weekly to a maximum of 20 mg/kg/day, with continued weekly monitoring of blood phenylalanine levels over a one month period.
V primeru ugotovljenega nezadovoljivega znižanja ravni fenilalanina v krvi je odmerek mogoče tedensko povečevati do največ 20 mg/kg/dan ob neprekinjenem tedenskem spremljanju ravni fenilalanina v krvi v obdobju enega meseca.
Kuvan 500 mg is for use in patients above 25 kg body weight only.
Zdravilo Kuvan 500 mg je samo za uporabo pri bolnikih s telesno maso nad 25 kg.
Available disease-associated maternal and/or embryofoetal risk data from the Maternal Phenylketonuria Collaborative Study on a moderate amount of pregnancies and live births (between 300-1,000) in PKU-affected women demonstrated that uncontrolled phenylalanine levels above 600 μmol/l are associated with a very high incidence of neurological, cardiac, facial dysmorphism, and growth anomalies.
Z boleznijo povezani podatki o tveganju za mater in/ali zarodek/plod, ki so na voljo iz medlaboratorijske študije fenilketonurije pri materah (Maternal Phenylketonuria Collaborative Study), ki je vključevala zmerno število nosečnosti in živorojenih otrok (med 300 in 1.000) pri ženskah, prizadetih zaradi PKU, so pokazali, da so nenadzorovane ravni fenilalanina nad 600 μmol/l povezane z zelo veliko pogostnostjo nevroloških, srčnih, rastnih anomalij in z obraznim dismorfizmom.
For instance, a calculated dose of 401 to 450 mg should be rounded down to 400 mg corresponding to 4 tablets.
Na primer, izračunani dnevni odmerek od 401 do 450 mg je potrebno zaokrožiti navzdol na 400 mg, kar ustreza odmerku 4 tablet.
• Empty the contents of the sachet(s) into 120 ml to 240 ml of water.
• Vsebino vrečic(e) izpraznite v 120 ml do 240 ml vode.
Kuvan has no or negligible influence on the ability to drive and use machines.
Zdravilo Kuvan nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Be sure that you know what dose of Kuvan powder your doctor prescribed.
Vedeti morate, kakšen odmerek praška zdravila Kuvan vam je zdravnik predpisal.
Kuvan reduces these levels in some patients who respond to BH4 and can help increase the amount of phenylalanine that can be included in the diet.
Zdravilo Kuvan zniža te ravni pri določenih bolnikih, ki se odzovejo na BH4, in tako pomaga, da je lahko količina fenilalanina, ki ga lahko vsebuje hrana, večja.
Based on the in vitro and in vivo results, co-administration of Kuvan is unlikely to increase systemic exposure to drugs that are substrates for BCRP.
Na podlagi rezultatov študij in vitro in in vivo ni verjetno, da bi sočasno dajanje zdravila Kuvan povečalo sistemsko izpostavljenost zdravilom, ki so substrati za BCRP.
Once responsiveness to the medicinal product has been established, the dose may be adjusted within the range of 5 to 20 mg/kg/day according to response to therapy.
Ko je enkrat ugotovljen odziv na to zdravilo, lahko odmerek prilagajamo v območju od 5 do 20 mg/kg/dan, glede na odziv na zdravljenje.
The following definitions apply to the frequency terminology used hereafter: 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 available data).
Pogostnosti so opredeljene z naslednjimi izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
Volume of dissolution (ml)
Volumen raztopine (ml)
The calculated daily dose based on body weight should be rounded to the nearest multiple of 100.
Na podlagi telesne mase izračunani dnevni odmerek je potrebno zaokrožiti na najbližji večkratnik števila 100.
Preparing the sachet(s):
Priprava vrečic(e):
The dietary phenylalanine intake should be maintained at a constant level during this period.
V tem obdobju je treba vnos fenilalanina s hrano ves čas ohranjati na enaki ravni.
You must continue your diet treatment as recommended by your doctor.
Z dietno prehrano, ki vam jo je priporočil zdravnik, morate nadaljevati.
Low blood phenylalanine and tyrosine levels
Nizke ravni fenilalanina in tirozina v krvi
Sustained or recurrent dysfunction in the phenylalanine-tyrosine-dihydroxy-L-phenylalanine (DOPA) metabolic pathway can result in deficient body protein and neurotransmitter synthesis.
Dolgotrajne ali ponavljajoče motnje v presnovni poti fenilalanin-tirozin-dihidroksi-L-fenilalanin (DOPA) imajo lahko za posledico nezadostno sintezo beljakovin in nevrotransmiterjev v telesu.
- if you are allergic to sapropterin or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na sapropterin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If after approximately 4 weeks, a patient's phenylalanine tolerance had not increased by >20% versus baseline, the Kuvan dose was increased in a single step to 20 mg/kg/day.
Če se po približno 4 tednih bolnikova toleranca organizma na fenilalanin ni povečala za > 20 % v primerjavi z izhodiščem, je bil odmerek zdravila Kuvan povečan v enem samem koraku na 20 mg/kg/dan.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni 'brez natrija'.
Give your child the prescribed amount of solution within 30 minutes after dissolving.
Otroku dajte predpisano količino raztopine v 30 minutah po raztopitvi.
• the amount of water needed to mix one dose of Kuvan
• količino vode, potrebne za mešanje enega odmerka zdravila Kuvan
Push on the plunger slowly, a small amount at a time, until all of the solution in the oral syringe is given.
Počasi pritiskajte na bat tako, da naenkrat iztisnete majhno količino, dokler ne daste vse raztopine v brizgi za peroralno dajanje.
Contents of the pack and other information What Kuvan contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Kuvan
The most commonly reported adverse reactions are headache and rhinorrhoea.
Neželena učinka, o katerih so poročali najpogosteje, sta glavobol in rinoreja.
Respiratory, thoracic and mediastinal disorders Very common:
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti:
In healthy subjects, administration of a single dose of Kuvan at the maximum therapeutic dose of 20 mg/kg had no effect on the pharmacokinetics of a single dose of digoxin (P-gp substrate) administered concomitantly.
Pri zdravih udeležencih dajanje enega odmerka zdravila Kuvan v najvišjem terapevtskem odmerku 20 mg/kg ni imelo nobenega učinka na farmakokinetiko enega odmerka digoksina (substrat za P-gp), danega sočasno.
In rats, following intravenous radiolabeled sapropterin administration, radioactivity was found to distribute in foetuses.
Pri podganah so po intravenskem dajanju radioaktivno označenega sapropterina ugotovili, da se radioaktivnost porazdeli v zarodke.
Safety and efficacy of Kuvan in patients with renal or hepatic insufficiency have not been established.
Varnost in učinkovitost zdravila Kuvan pri bolnikih z zmanjšanim delovanjem ledvic ali jeter nista bili dokazani.
If you are allergic to sapropterin or any of the other ingredients of this medicine (listed in section 6).
Če ste alergični na sapropterin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The oral syringe and the cup should be stored for next use.
Brizgo za peroralno dajanje in merico je treba shraniti za naslednjo uporabo.
Give your child the prescribed amount of solution within 15 to 20 minutes after dissolving.
Otroku dajte predpisano količino raztopine v 15 do 20 minutah po raztopitvi.
The solution may then be transferred to another cup for administration of the medicinal product.
Raztopina se nato lahko prenese v drugo merico za dajanje zdravila.
Sapropterin is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan.
Sapropterin je sintezna oblika naravno pojavljajočega 6R-BH4, ki je kofaktor hidroksilaz za fenilalanin, tirozin in triptofan.
Divide the total daily dose into 2 or 3 doses, taken over the day.
Celoten dnevni odmerek razdelite na dva ali tri odmerke, ki jih razporedite preko dneva.
If you forget to take Kuvan
Če ste pozabili vzeti zdravilo Kuvan
In the pivotal clinical trials and in the post-marketing experience for Kuvan, the following adverse reactions have been identified.
V ključnih kliničnih preizkušanjih in v obdobju po prihodu zdravila Kuvan na trg so opazili naslednje neželene učinke.
Volume of solution to be administered (ml)*
Volumen raztopine za uporabo (ml)*
Sapropterin is absorbed after oral administration of the dissolved tablet, and the maximum blood concentration (Cmax) is achieved 3 to 4 hours after dosing in the fasted state.
Sapropterin se po peroralnem zaužitju raztopljene tablete absorbira, najvišja koncentracija v krvi (Cmax) pa je dosežena tri do štiri ure po zaužitju odmerka na tešče.
For patients above 20 kg body weight, the calculated daily dose based on body weight should be rounded to the nearest multiple of 100 mg.
Za bolnike s telesno maso več kot 20 kg je treba izračunani dnevni odmerek na podlagi telesne mase zaokrožiti na najbližji večkratnik 100 mg.
Sapropterin was found to be weakly mutagenic in bacterial cells and an increase in chromosome aberrations was detected in Chinese hamster lung and ovary cells.
Ugotovili so, da ima sapropterin šibak mutagen učinek na bakterijske celice, pri pljučnih celicah in celicah jajčnikov kitajskih hrčkov pa so zaznali porast kromosomskih aberacij.
Drink the dissolved preparation of Kuvan with a meal within 15 to 20 minutes of its preparation.
Raztopljeno zdravilo Kuvan je treba popiti ob obroku v 15 do 20 minutah po pripravi.
Do not stop taking Kuvan without prior discussion with your doctor, as phenylalanine levels in your blood may increase.
Z jemanjem zdravila Kuvan ne smete prenehati, ne da bi se pred tem posvetovali s svojim zdravnikom, ker se ravni fenilalanina v vaši krvi lahko zvišajo.
Depending on the dose (in mg/kg/day) the appropriate number of tablets should be dissolved in a volume of water as depicted in Tables 1-4, whereby the volume of the solution to be administered is calculated according to the prescribed total daily dose.
Odvisno od odmerka (v mg/kg/dan) je treba ustrezno število tablet raztopiti v volumnu vode, navedenim v preglednicah 1-4, pri čemer se volumen raztopine za uporabo izračuna v skladu s predpisanim skupnim dnevnim odmerkom.
The rationale for administration of Kuvan in patients with BH4 Deficiency is to replace the deficient levels of BH4, thereby restoring the activity of phenylalanine hydroxylase.
Osnovni princip zdravljenja z zdravilom Kuvan pri bolnikih s pomanjkanjem BH4 je nadomestitev nezadostnih ravni BH4 in s tem obnovitev aktivnosti fenilalanin hidroksilaze.
BH4 is required by the body to use an amino acid called phenylalanine in order to build another amino acid called tyrosine.
Telo spojino BH4 potrebuje, da lahko uporabi aminokislino, imenovano fenilalanin, zato da lahko tvori drugo aminokislino, imenovano tirozin.
More frequent monitoring may be required, as blood phenylalanine levels may increase.
Morda bo potrebno pogostejše spremljanje, saj se lahko ravni fenilalanina v krvi zvišajo.
Response to this medicinal product is determined by a decrease in blood phenylalanine.
Odziv na to zdravilo se določa z znižanjem ravni fenilalanina v krvi.
Your doctor should continue to monitor your blood phenylalanine levels often during your treatment with Kuvan, to make sure that your blood phenylalanine levels are not too high or too low.
Zdravnik mora med zdravljenjem z zdravilom Kuvan še naprej pogosto spremljati ravni fenilalanina v krvi, da zagotovi, da ravni fenilalanina niso previsoke ali prenizke.
Based on an in vitro study, there is potential for sapropterin dihydrochloride to inhibit p-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in the gut at the therapeutic doses.
Na podlagi študije in vitro obstaja možnost, da bo zdravilo sapropterinijev diklorid v terapevtskih odmerkih zaviralo p-glikoprotein (P-gp) in protein odpornosti pri raku dojke (BCRP - breast cancer resistance protein) v črevesju.