natgillin/translations-raw huggingface dataset:
Before using your DuoResp Spiromax for the first time, you need to prepare it for use as follows: 
Preden prvikrat uporabite nov inhalator DuoResp Spiromax, ga morate pripraviti za uporabo na naslednji način: • Vrečko iz folije odprite, tako da jo raztrgate na zarezi na vrhu vrečke iz folije, in iz nje vzemite inhalator.
Preparing your new DuoResp Spiromax 
Priprava novega inhalatorja DuoResp Spiromax
If the patient experiences paradoxical bronchopasm DuoResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary. 
V tem primeru je treba zdravljenje z zdravilom DuoResp Spiromax takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja.
Each DuoResp Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover. 
60 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim pokrovčkom ustnika.
The most common symptoms that may occur after when you use more DuoResp Spiromax than you should are trembling, headache or a rapid heartbeat. 
Najpogostejši simptomi, ki se lahko pojavijo, če ste uporabili večji odmerek zdravila DuoResp
Serious asthma-related adverse reactions and exacerbations may occur during treatment with DuoResp Spiromax. 
Med zdravljenjem z zdravilom DuoResp Spiromax se lahko pojavijo resni neželeni učinki, povezani z astmo, in poslabšanje bolezni.
Adults (18 years and older): 1 inhalation twice daily. 
Odrasli (18 let in več): 1 vdih dvakrat na dan
Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of DuoResp Spiromax as-needed inhalations. 
Pri bolnikih, ki pogosto uporabljajo veliko število inhalacij zdravila DuoResp Spiromax po potrebi, je treba skrbno nadzorovati z odmerkom povezane neželene učinke.
DuoResp Spiromax 320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use. 
DuoResp Spiromax 320 mcg/9 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
Tell your doctor if you have any of the following while taking DuoResp Spiromax they could be symptoms of a lung infection: 
• pljučnica (okužba pljuč) pri bolnikih s KOPB (pogost neželen učinek) Svojemu zdravniku morate povedati, če imate med jemanjem zdravila DuoResp Spiromax kar koli od naštetega, ker so to lahko simptomi okužbe pljuč:
DuoResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use. 
DuoResp Spiromax 160 mcg/4,5 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
DuoResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate 
DuoResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
How to store DuoResp Spiromax 
Shranjevanje zdravila DuoResp Spiromax
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate 
DuoResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
• If you have been prescribed DuoResp Spiromax and a separate reliever inhaler, read the section called 
• Če vam je zdravnik predpisal zdravilo DuoResp Spiromax in ločen inhalator z olajševalcem, potem preberite poglavje »(A) Uporaba zdravila DuoResp Spiromax in ločenega inhalatorja z olajševalcem«.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with DuoResp Spiromax. 
Če po uvedbi zdravila DuoResp Spiromax simptomi astme niso nadzorovani ali se poslabšajo, naj bolniki nadaljujejo z zdravljenjem in poiščejo zdravniško pomoč.
Study months 
Številka študije / trajanje
DuoResp Spiromax maintenance and reliever therapy 
Zdravilo DuoResp Spiromax za vzdrževalno in olajševalno zdravljenje: Zdravilo DuoResp
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use. 
DuoResp Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
What you need to know before you use DuoResp Spiromax 3. 
Kaj je zdravilo DuoResp Spiromax in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo DuoResp Spiromax Kako uporabljati zdravilo DuoResp Spiromax
Package leaflet: Information for the patient DuoResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate 
Navodilo za uporabo DuoResp Spiromax 320 mikrogramov/9 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
OF THE MEDICINAL PRODUCT 
UČINKOVITO UPORABO ZDRAVILA
Package leaflet: Information for the patient DuoResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate 
Navodilo za uporabo DuoResp Spiromax 160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use. 
DuoResp Spiromax 320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening Your doctor may increase this to 4 inhalations, twice a day. 
1 ali 2 vdiha (sprožitvi) dvakrat na dan, uporabi se zjutraj in zvečer.
This will change as your child grows. 
To se bo z otrokovo rastjo spremenilo.
Take the next dose at the usual time. 
Vzemite naslednji odmerek ob običajnem času.
Use in all patients 
Uporaba pri vseh bolnikih
• A glass or cup 
• kozarec ali skodelica
Their frequency is not known (frequency cannot be estimated from the available data). 
Njihova pogostnost ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
It may take a few minutes for the tablets to dissolve. 
Lahko traja nekaj minut, da se tablete raztopijo.
Open the sachet(s) only when you are ready to use them. 
Vrečico(ce) odprite šele, ko ste pripravljeni na uporabo.
Treatment of overdose should be directed to symptoms. 
Zdravljenje prevelikega odmerjanja mora biti usmerjeno k simptomom.
*Reflects volume for total daily dose. 
*Odraža količino celotnega dnevnega odmerka.
See leaflet for further information. 
Glejte navodilo za več informacij.
If you notice these signs, contact your doctor immediately. 
Če opazite takšne znake, takoj stopite v stik s svojim zdravnikom.
The table below is an example of how an appropriate dose is calculated 
Spodnja tabela podaja primer izračuna ustreznega odmerka
If you are pregnant your doctor will tell you how to control phenylalanine levels adequately. 
Če ste nosečnosti, vam bo vaš zdravnik povedal, kako boste ustrezno nadzorovali raven fenilalanina.
Do not change your diet without contacting your doctor. 
Svoje prehrane ne smete spreminjati brez posvetovanja z zdravnikom.
What Kuvan is and what it is used for 
Kaj je zdravilo Kuvan in za kaj ga uporabljamo
Paediatric population The posology is the same in adults, children and adolescents. 
Pediatrična populacija Odmerjanje je enako za odrasle, otroke in mladostnike.
Few cases of allergic reactions (such as skin rash and serious reactions) have been reported. 
Poročali so o nekaj primerih alergijskih reakcij (kot je kožni izpuščaj in hude reakcije).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. 
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
Discontinuation of treatment should be done only under the supervision of a physician. 
Zdravljenje se lahko prekine le pod nadzorom zdravnika.
Population pharmacokinetic analysis of sapropterin including patients from birth to 49 years of age showed that body weight is the only covariate substantially affecting clearance or volume of distribution. 
Analiza populacijske farmakokinetike sapropterina, vključno z bolniki od rojstva do 49 let starosti, je pokazala, da je telesna masa edina sospremenljivka, ki bistveno vpliva na očistek ali volumen porazdelitve.
Health disturbances 
Motnje zdravja
BH4 deficiency 
Pomanjkanje BH4
Safety and efficacy of Kuvan in patients above 65 years of age have not been established. 
Varnost in učinkovitost zdravila Kuvan pri bolnikih, starejših od 65 let, nista bili dokazani.
• the amount of solution you will need to give your child for their prescribed dose 
• količino raztopine, ki jo boste morali dati otroku za njegov predpisani odmerek
For small infants an oral syringe can be used. 
Za manjše otroke je možno uporabiti brizgo za peroralno dajanje.
Very common side effects (may affect more than 1 in 10 people) Headache and runny nose. 
Zelo pogosta neželena učinka (lahko se pojavijo pri več kot 1 od 10 bolnikov) glavobol in izcedek iz nosu.
For instructions for use, see section 4.2. 
Za navodila za uporabo glejte poglavje 4.2.
EU/1/08/481/004 100 mg sachet EU/1/08/481/005 500 mg sachet 
EU/1/08/481/004 100 mg vrečica EU/1/08/481/005 500 mg vrečica
Taking the medicine • Drink the solution within 30 minutes. 
Jemanje zdravila • Raztopino spijte v 30 minutah.
Each bottle contains 30, 120 or 240 tablets. 
Vsaka plastenka vsebuje 30, 120 ali 240 tablet.
Steps for preparing and taking your dose: 
Postopek za pripravo in jemanje odmerka:
In vitro, sapropterin did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4/5, nor induce CYP1A2, 2B6, or 3A4/5. 
In vitro sapropterin ni zaviral CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4/5 in ni aktiviral CYP1A2, 2B6 ali 3A4/5.
• If your baby is too small to drink from a glass or a cup you may administer the solution via the oral syringe. 
• Če je dojenček premajhen, da bi pil iz kozarca ali skodelice, mu lahko raztopino daste z brizgo za peroralno dajanje.
Each carton contains 30 sachets. 
Vsaka škatla vsebuje 30 vrečic.
• A medicine cup with graduation markings at 20, 40, 60 and 80 ml 
• merica za zdravilo z oznakami za 20, 40, 60 in 80 ml
The dose is based on body weight. 
Odmerek je odvisen od telesne mase.
BH4 deficiency is a group of disorders arising from mutations or deletions in the genes encoding for one of the five enzymes involved in the biosynthesis or recycling of BH4. 
Pomanjkanje BH4 je skupina motenj, do katerih pride zaradi mutacij ali izbrisov v genih, ki kodirajo enega izmed petih encimov, ki sodelujejo pri biosintezi ali recikliranju BH4.
Because of very low BH4 levels phenylalanine is not used properly and its levels rise, resulting in harmful effects. 
Zaradi nizkih ravni BH4 se fenilalanin ne more ustrezno uporabljati in se zato njegove ravni povišajo, kar ima za posledico škodljive učinke.
The solution should be drank within 15 to 20 minutes. 
Raztopino je treba popiti v 15 do 20 minutah.
Absolute bioavailability or bioavailability for humans after oral administration is not known. 
Absolutna biološka uporabnost ali biološka uporabnost pri ljudeh po peroralnem odmerku ni poznana.
If you take more Kuvan than prescribed, you may experience side effects that could include headache and dizziness. 
Če vzamete večji odmerek zdravila Kuvan od predpisanega, se pri vas lahko pojavijo neželeni učinki, ki lahko vključujejo glavobol in omotico.
No clear evidence of teratogenic activity was found in rats and in rabbits at doses of approximately 3 and 10 times the maximum recommended human dose, based on body surface area. 
Pri podganah in zajcih niso našli nobenega jasnega dokaza o teratogenem delovanju pri odmerkih, ki so bili približno 3- in 10-kratniki največjega priporočenega odmerka pri ljudeh, na osnovi velikosti površine telesa.
If these are not strictly controlled before or when you become pregnant, this could be harmful to you and to your baby. 
Če pred ali med nosečnostjo te ravni niso skrbno nadzorovane, lahko to škoduje vam in vašemu otroku.
Oral use, after dissolution. 
Peroralna uporaba, po raztapljanju.
Slowly pull back the plunger to withdraw the amount as instructed by your doctor. 
Bat počasi vlecite nazaj in izvlecite količino, kot vam je naročil zdravnik.
To make the tablets dissolve faster you can crush them. 
Da se tablete hitreje raztopijo, jih lahko prej zdrobimo.
It is of primary importance to initiate treatment as early as possible to avoid the appearance of non-reversible clinical manifestations of neurological disorders in paediatric patients and cognitive deficits and psychiatric disorders in adults due to sustained elevations of blood phenylalanine. 
Najbolj pomembno je, da se z zdravljenjem začne čim prej, da se izognemo pojavu ireverzibilnih kliničnih manifestacij nevroloških motenj pri pediatričnih bolnikih in kognitivnega primanjkljaja ter psihičnih motenj pri odraslih zaradi dolgotrajno povišanih ravni fenilalanina v krvi.
Your child should drink the solution with a meal. 
Vaš otrok naj raztopino spije z obrokom.
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.