FrancophonIA/ELRC3.0 huggingface dataset:
English: The appropriate number of 100 mg sachet(s) should be dissolved in a volume of water depicted in Tables 1-4 based on the prescribed total daily dose.
Croatian: Potrebno je otopiti odgovarajući broj vrećica od 100 mg u volumenu vode kako je prikazano u tablicama 1-4 prema propisanoj ukupnoj dnevnoj dozi.
English: The prescribed number of tablets should be placed in a glass or cup of water and stirred until dissolved.
Croatian: Propisani broj tableta treba staviti u čašu ili šalicu vode i miješati sve dok se ne otope.
English: For BH4 deficiency patients, the total daily dose is divided into 2 or 3 doses over the day.
Croatian: Za bolesnike s nedostatkom BH4, ukupnu dnevnu dozu treba podijeliti na 2 ili 3 doze tijekom dana.
English: The prescribed number of tablets for a 2, 5, 10 and 20 mg/kg/day dose should be placed in a cup (that shows the appropriate graduation markings at 20, 40, 60 and 80 ml) with the amount of water as depicted in Tables 1-4 and stirred until dissolved.
Croatian: Propisani broj tableta za dozu od 2, 5, 10 i 20 mg/kg na dan treba staviti u čašicu (s odgovarajućim mjernim oznakama za 20, 40, 60 i 80 ml) s određenom količinom vode kako je prikazano u tablicama 1-4, te miješati do otapanja.
English: 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.
Croatian: Kuvan smanjuje koncentraciju fenilalanina u nekih bolesnika koji odgovaraju na BH4 te može pomoći da se količina fenilalanina koja se uzima hranom poveća.
English: Cases of convulsion, exacerbation of convulsion, increased excitability and irritability have been observed during co-administration of levodopa and sapropterin in BH4-deficient patients.
Croatian: Slučajevi konvulzija, pogoršanja konvulzija, povećane podražljivosti i iritabilnosti zamijećeni su tijekom istovremene primjene levodope i sapropterina kod pacijenata s manjkom BH4.
English: Treatment with sapropterin may decrease blood phenylalanine levels below the desired therapeutic level.
Croatian: Liječenje sapropterinom može smanjiti koncentraciju fenilalanina u krvi ispod željene terapijske koncentracije.
English: The results of these studies demonstrate the efficacy of Kuvan to reduce blood phenylalanine levels and to increase dietary phenylalanine tolerance.
Croatian: Rezultati tih ispitivanja pokazuju djelotvornost Kuvana u smanjivanju koncentracija fenilalanina u krvi i povećanju tolerancije unosa fenilalanina hranom.
English: Low blood phenylalanine and tyrosine levels
Croatian: Niske koncentracije fenilalanina i tirozina u krvi
English: In a further clinical trial, approximately 30% of the 27 children aged below 4 years who received treatment with sapropterin dihydrochloride (10 or 20 mg/kg/day) experienced adverse reactions.
Croatian: U sljedećem kliničkom ispitivanju, od 27 djece u dobi ispod 4 godine koja su bila liječena sapropterindikloridom (10 ili 20 mg/kg na dan) približno je 30% imalo nuspojave.
English: Soluble tablet Off-white to light yellow soluble tablet with “177” imprinted on one face.
Croatian: Tableta za oralnu otopinu Gotovo bijela do svijetložuta tableta za oralnu otopinu s utisnutom oznakom „177“ na jednoj strani.
English: This medicine contains potassium citrate (E332).
Croatian: Lijek sadrži kalijev citrat (E332).
English: Both parts of the oral syringe and the cup should be washed with warm water and air dry.
Croatian: Oba dijela oralne štrcaljke i čašicu treba isprati toplom vodom i ostaviti ih da se osuše na zraku.
English: Kuvan 100 mg soluble tablets are off-white to light yellow with “177” imprinted on one face.
Croatian: Kuvan 100 mg tablete za oralnu otopinu su gotovo bijele do svijetložute boje i imaju utisnutu oznaku „177“ na jednoj strani.
English: Patients treated with Kuvan must continue a restricted phenylalanine diet and undergo regular clinical assessment (such as monitoring of blood phenylalanine and tyrosine levels, nutrient intake, and psycho-motor development).
Croatian: Bolesnici koji se liječe lijekom Kuvan moraju nastaviti s dijetom s ograničenom količinom fenilalanina i redovito se podvrgavati kliničkim kontrolama (npr. nadzoru koncentracija fenilalanina i tirozina u krvi, unosa nutrijenata i psihomotoričkog razvoja).
English: Blood phenylalanine levels should be checked before administering Kuvan and after 1 week of use at the recommended starting dose.
Croatian: Koncentracije fenilalanina u krvi moraju se provjeriti prije primjene lijeka Kuvan te nakon tjedan dana uporabe u preporučenoj početnoj dozi.
English: It is available in bottles with child-resistant closure of 30, 120 or 240 soluble tablets.
Croatian: Kuvan je dostupan u bocama sa sigurnosnim zatvaračem za djecu sa 30, 120 ili 240 tableta za oralnu otopinu.
English: The rate and extent of absorption of sapropterin is influenced by food.
Croatian: Hrana ima utjecaj na brzinu i stupanj apsorpcije sapropterina.
English: Kuvan is used to treat hyperphenylalaninaemia (HPA) or phenylketonuria (PKU) in patients of all ages.
Croatian: Kuvan se primjenjuje za liječenje hiperfenilalaninemije (HPA) ili fenilketonurije (PKU) u bolesnika svih dobi.
English: It was intended that all patients maintained blood phenylalanine levels within a range of 120-360 µmol/l (defined as ≥120 to <360 µmol/l) through monitored dietary intake during the 26-week Study Period.
Croatian: Namjera je bila da se u svih bolesnika koncentracija fenilalanina u krvi održava unutar raspona od 120-360 µmol/l (definiranog kao raspon ≥120 do <360 µmol/l) tijekom 26 tjedana ispitivanja nadzorom unosa putem hrane.
English: For the exact dose your doctor may also prescibe Kuvan 100 mg powder for oral solution.
Croatian: Za točnu dozu, Vaš liječnik također može propisati Kuvan 100 mg prašak za oralnu otopinu.
English: Each bottle contains a small plastic tube of desiccant (silica gel).
Croatian: Svaka boca sadrži mali plastični spremnik sa sredstvom za sušenje (silikagel).
English: The measuring devices required for dosing in children up to 20 kg body weight (i.e. cup with graduations at 20, 40, 60, 80 ml; 10 ml and 20 ml oral syringes with graduation at 1 ml divisions) are not included in the Kuvan pack.
Croatian: Mjerni pribor potreban za doziranje u djece tjelesne težine do 20 kg (npr. čašica s mjernim oznakama za 20, 40, 60, 80 ml; oralne štrcaljke od 10 ml i 20 ml graduirane po 1 ml) nije uključen u pakiranje Kuvana.
English: Small particles may be visible in the solution and will not affect the effectiveness of the medicinal product.
Croatian: Male čestice koje se mogu vidjeti u otopini, ne smetaju i ne umanjuju učinkovitost lijeka.
English: 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.
Croatian: Tijekom liječenja Kuvanom, Vaš liječnik treba nastaviti pratiti razine fenilalanina u Vašoj krvi kako biste bili sigurni da Vam razina fenilalanina u krvi nije previsoka ili preniska.
English: In 88 subjects with poorly controlled PKU who had elevated blood phenylalanine levels at screening, sapropterin dihydrochloride 10 mg/kg/day significantly reduced blood phenylalanine levels as compared to placebo.
Croatian: Kod 88 ispitanika s loše kontroliranom PKU, koji su pri probiru imali povišenu koncentraciju fenilalanina, sapropterindiklorid u dozi od 10 mg/kg/dnevno značajno je smanjio koncentraciju fenilalanina u usporedbi s placebom.
English: By replacing the BH4 that the body cannot produce, Kuvan reduces the harmful excess of phenylalanine in the blood and increases the dietary tolerance to phenylalanine.
Croatian: Kuvan nadomješta BH4 koji tijelo ne može proizvesti te se tako štetni višak fenilalanina u krvi smanjuje i povećava tolerancija na fenilalanin u prehrani.
English: The mean ± SD decrease from baseline in blood phenylalanine levels at the end of the 6 week study period was 236 ± 257 μmol/l for the sapropterin treated group (n=41) as compared to an increase of 2.9 ± 240 μmol/l for the placebo group (n=47) (p<0.001).
Croatian: Srednja vrijednost sniženja ± SD od početne koncentracije fenilalanina u krvi nakon 6 tjedana ispitivanja bilo je 236 ± 257 µmol/l za skupinu liječenu sapropterinom (n=41) u odnosu na povećanje od 2,9 ± 240 µmol/l u placebo skupini (n=47) (p<0,001).
English: The results of this study demonstrated that daily dosing with 10 or 20 mg/kg/day of Kuvan in conjunction with a phenylalanine-restricted diet led to statistically significant improvements in dietary phenylalanine tolerance compared with dietary phenylalanine restriction alone while maintaining blood phenylalanine levels within the target range (≥120 to <360 µmol/l).
Croatian: Rezultati ovog ispitivanja pokazali su da je svakodnevno davanje Kuvana u dozi od 10 ili 20 mg/kg na dan uz prehranu siromašnu fenilalaninom dovelo do statistički značajnog poboljšanja u toleranciji na fenilalanin unesen hranom u usporedbi sa samo prehranom siromašnom fenilalaninom, pri čemu je koncentracija fenilalanina u krvi bila održana unutar ciljnog raspona (od ≥120 do <360 µmol/l).
English: Cases of convulsion, exacerbation of convulsion, increased excitability and irritability have been observed during co-administration of levodopa and sapropterin in BH4-deficient patients (see section 4.5).
Croatian: Slučajevi konvulzija, pogoršanja konvulzija, povećane podražljivosti i iritabilnosti zamijećeni su tijekom istovremene primjene levodope i sapropterina kod pacijenata s manjkom BH4 (vidjeti dio 4.5).
English: How to store Kuvan
Croatian: Kako čuvati Kuvan
English: For the sapropterin treatment group, the mean ± SD total dietary phenylalanine tolerance was 38.4 ± 21.6 mg/kg/day during treatment with sapropterin dihydrochloride 20 mg/kg/day compared to 15.7 ± 7.2 mg/kg/day before treatment.
Croatian: Za skupinu liječenu sapropterinom srednja vrijednost ± SD ukupne tolerancije na fenilalanin u prehrani bila je 38,4 ± 21,6 mg/kg/dnevno tijekom liječenja dozom sapropterindiklorida od 20 mg/kg/dnevno, u usporedbi s 15,7 ± 7,2 mg/kg/dnevno prije liječenja.
English: To make the tablets dissolve faster they can be crushed.
Croatian: Kako bi se otapanje ubrzalo, tablete se smiju izmrviti.
English: 56 paediatric PKU patients <4 years of age were randomised 1:1 to receive either 10 mg/kg/day Kuvan in conjunction with a phenylalanine-restricted diet (n=27), or just a phenylalanine-restricted diet (n=29) over a 26-week Study Period.
Croatian: 56 pedijatrijskih bolesnika s PKU u dobi <4 godine bilo je randomizirano u omjeru 1:1 u skupinu koja je primala Kuvan u dozi od 10 mg/kg na dan uz prehranu siromašnu fenilalaninom (n=27) ili skupinu koja je bila samo na prehrani siromašnoj fenilalaninom (n=29) tijekom 26 tjedana ispitivanja.
English: Caution must be exercised when prescribing to elderly patients.
Croatian: Nužan je oprez kod propisivanja lijeka Kuvan starijim bolesnicima.
English: Do not use this medicine after the expiry date which is stated on the sachet and the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vrećici i kutiji iza oznake „EXP“.
English: Kuvan contains the active substance sapropterin which is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4).
Croatian: Kuvan sadrži djelatnu tvar sapropterin koja je sintetska kopija tetrahidrobiopterina (BH4), tvari koja se prirodno nalazi u ljudskom tijelu.
English: Remove the plunger from the barrel of the oral syringe.
Croatian: Izvadite klip iz tijela oralne štrcaljke.
English: - The other ingredients are mannitol (E421), potassium citrate (E332), sucralose (E955), ascorbic acid (E300).
Croatian: - Drugi sastojci su manitol (E421); kalijev citrat (E332), sukraloza (E955), askorbatna kiselina (E300).
English: Oral use, after dissolution.
Croatian: Za primjenu kroz usta, nakon otapanja.
English: • Oral syringe (graduated in 1 ml divisions) (10 ml syringe for administration of volumes of
Croatian: • oralna štrcaljka (s mjernim oznakama po 1 ml) (štrcaljka od 10 ml za primjenu volumena
English: (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP), molsidomin), phosphodiesterase type 5 (PDE-5) inhibitors and minoxidil.
Croatian: (ISDN), natrijev nitroprusid (SNP), molsidomin i minoksidil).
English: There are limited amount of data from the use of Kuvan in pregnant women.
Croatian: Podaci o primjeni lijeka Kuvan u trudnica su ograničeni.
English: For patients with baseline blood phenylalanine levels ≥600 µmol/l, 41.9% (13/31) of those treated with sapropterin and 13.2% (5/38) of those treated with placebo had blood phenylalanine levels < 600 µmol/l at the end of the 6-week study period (p=0.012).
Croatian: Među bolesnicima s početnim koncentracijama fenilalanina u krvi ≥600 µmol/l, 41,9% (13/31) od onih koji su liječeni sapropterinom i 13,2% (5/38) od onih kojima je davan placebo, imali su na kraju 6 tjedana ispitivanja koncentracije fenilalanina u krvi manje od 600 µmol/l (p=0,012).
English: Volume of solution to be administered (ml)*
Croatian: Volumen otopine koji će se primijeniti (ml)*
English: - The other ingredients are mannitol (E421), calcium hydrogen phosphate anhydrous, crospovidone type A, ascorbic acid (E300), sodium stearyl fumarate, and riboflavin (E101).
Croatian: - Drugi sastojci su manitol (E421); kalcijev hidrogenfosfat, bezvodni; krospovidon tip A; askorbatna kiselina (E300); natrijev stearilfumarat i riboflavin (E101).
English: Stir with the small spoon or clean utensil until the powder dissolves.
Croatian: Miješajte malom žlicom ili čistim priborom za miješanje sve dok se prašak ne otopi.
English: For higher doses, your doctor may also prescibe Kuvan 500 mg powder for oral solution.
Croatian: Za više doze, Vaš liječnik također može propisati Kuvan 500 mg prašak za oralnu otopinu.
English: Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment (see section 4.2).
Croatian: Kuvan je indiciran za liječenje hiperfenilalaninemije (HPA) u odraslih i pedijatrijskih bolesnika svih dobi s fenilketonurijom (PKU) kod kojih se pokazalo da odgovaraju na ovakvo liječenje (vidjeti dio 4.2).
English: When you are treated with Kuvan, your doctor will test your blood to verify how much phenylalanine and tyrosine it contains and may decide to adjust the dose of Kuvan or your diet if needed.
Croatian: Vaš će liječnik tražiti pretrage krvi kako bi saznao koncentraciju fenilalanina i tirozina i kako bi, po potrebi, prilagodio dozu Kuvana ili Vašu prehranu.
English: The prescribed number of tablets should be placed in a glass or cup with 120 to 240 ml of water and stirred until dissolved.
Croatian: Propisani broj tableta treba staviti u čašu ili šalicu sa 120 do 240 ml vode i miješati sve dok se tablete ne otope.
English: Patients above 20 kg body weight The contents of the sachet(s) should be placed in 120 to 240 ml of water and stirred until dissolved.
Croatian: Bolesnici tjelesne težine iznad 20 kg Sadržaj vrećice(a) je potrebno istresti u 120 do 240 ml vode i promiješati dok se ne otopi.
English: This will change as your child grows.
Croatian: Doza se temelji na tjelesnoj težini, te će se mijenjati kako dijete raste.
English: Consultation with a physician is recommended during illness as blood phenylalanine levels may increase.
Croatian: Preporučuje se konzultirati liječnika ako ste bolesni, budući da se tada koncentracije fenilalanina u krvi mogu povećati.
English: Each bottle of Kuvan contains a small plastic tube of desiccant (silica gel).
Croatian: Svaka boca lijeka Kuvan sadrži mali plastični spremnik sa sredstvom za sušenje (silikagel).
English: Even if you take Kuvan, if your phenylalanine blood levels are not well controlled, you can develop severe neurologic problems.
Croatian: Čak i ako uzimate Kuvan, možete razviti teška neurološka oštećenja ako Vam razine fenilalanina u krvi nisu dobro kontrolirane.
English: • Transfer the solution by pushing on the plunger slowly until all of the solution in the oral syringe is transferred to a glass or cup for administration (e.g. if your doctor told you to dissolve two Kuvan tablets in 40 ml water and administer 30 ml to your child, you would have to use the 20 ml oral syringe two times to draw up 30 ml (e.g. 20 ml + 10 ml) of the solution and transfer it to a glass or cup for administration).
Croatian: • Prenesite otopinu tako što ćete polako potiskivati klip sve dok ne istisnete svu otopinu iz oralne štrcaljke u čašu ili šalicu za primjenu (npr. ako Vam je liječnik rekao da otopite dvije tablete Kuvana u 40 ml vode i djetetu date 30 ml, morat ćete dvaput uporabiti oralnu štrcaljku od 20 ml kako biste izvukli 30 ml (npr. 20 ml + 10 ml) otopine i prenijeli je u čašu ili šalicu za primjenu.
English: • Transfer the solution by pushing on the plunger slowly until all of the solution in the oral syringe is transferred to a glass or cup for administration (e.g. if your doctor told you to dissolve two Kuvan 100 mg sachets in 40 ml water and administer 30 ml to your child, you would have to use the 20 ml oral syringe two times to draw up 30 ml (e.g. 20 ml + 10 ml) of the solution and transfer it to a glass or cup for administration).
Croatian: • Prenesite otopinu tako što ćete polako potiskivati klip sve dok ne istisnete svu otopinu iz oralne štrcaljke u čašu ili šalicu za primjenu (npr. ako Vam je liječnik rekao da otopite dvije vrećice od 100 mg Kuvana u 40 ml vode i djetetu date 30 ml, morat ćete dvaput uporabiti oralnu štrcaljku od 20 ml kako biste izvukli 30 ml (npr. 20 ml + 10 ml) otopine i prenijeli ih u čašu ili šalicu za primjenu.
English: For patients with PKU, Kuvan should be administered as a single daily dose, and at the same time each day preferably in the morning.
Croatian: Za bolesnike s PKU, Kuvan treba uzimati u jednoj dnevnoj dozi, svakog dana u isto vrijeme, poželjno ujutro.
English: • Place the prescribed number of Kuvan 100 mg sachets in the medicine cup.
Croatian: • Stavite propisani broj vrećica od 100 mg lijeka Kuvan u čašicu za lijek.
English: In a separate 10-week, placebo-controlled study, 45 PKU patients with blood phenylalanine levels controlled on a stable phenylalanine-restricted diet (blood phenylalanine ≤480 μmol/l on enrolment) were randomised 3:1 to treatment with sapropterin dihydrochloride 20 mg/kg/day (n=33) or placebo (n=12).
Croatian: U odvojenom, 10-tjednom placebom kontroliranom ispitivanju, 45 PKU bolesnika s koncentracijama fenilalanina u krvi kontroliranima pri prehrani sa stalno jednakim ograničenjem unosa fenilalanina hranom (fenilalanin u krvi ≤480 µmol/l na početku istraživanja), randomizirano je u omjeru 3:1, za liječenje dozom od 20 mg/kg/dnevno sapropterindiklorida (n=33) ili placebom (n=12).
English: Place the prescribed number of tablets in a glass or cup of water as accurately described below and stir until dissolved.
Croatian: Stavite propisani broj tableta u čašu ili šalicu s vodom točno onako kako je opisano u daljnjem tekstu i miješajte dok se tablete ne otope.
English: The recommended starting dose of Kuvan in patients with BH4 deficiency is 2 to 5 mg for each kg of body weight.
Croatian: Preporučena početna doza lijeka Kuvan u bolesnika s nedostatkom BH4 je 2 do 5 mg na svaki kilogram tjelesne težine.
English: This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Croatian: O tome treba voditi računa u bolesnika sa smanjenom funkcijom bubrega ili bolesnika na prehrani s ograničenjem unosa kalija.
English: ≤10 ml or 20 ml syringe for administration of volumes of >10 ml)
Croatian: ≤10 ml ili štrcaljka od 20 ml za primjenu volumena >10 ml).
English: For patients with BH4 deficiency, divide the total daily dose into 2 or 3 administrations, distributed over the day.
Croatian: Za bolesnike s nedostatkom BH4, ukupnu dnevnu dozu podijelite na 2 ili 3 pojedinačne primjene raspoređene tijekom dana.
English: After 3 weeks, subjects in both the sapropterin and placebo treatment groups were continued on their phenylalanine-restricted diets and dietary phenylalanine intake was increased or decreased using standardised phenylalanine supplements with a goal to maintain blood phenylalanine levels at <360 μmol/l.
Croatian: Nakon 3 tjedna, ispitanici iz obje skupine, oni koji su liječeni sapropterinom i oni koji su dobivali placebo, nastavili su s prehranom siromašnom fenilalaninom, a unos fenilalanina hranom je povećan ili smanjen pomoću standardnih obroka s poznatom količinom fenilalanina, s ciljem da se koncentracije fenilalanina u krvi održe ispod 360 μmol/l.
English: The recommended starting dose of Kuvan in patients with PKU is 10 mg for each kg of body weight.
Croatian: Preporučena početna doza lijeka Kuvan u bolesnika s PKU je 10 mg za svaki kg tjelesne težine.
English: After 3 weeks of treatment with sapropterin dihydrochloride 20 mg/kg/day, blood phenylalanine levels were significantly reduced; the mean ± SD decrease from baseline in blood phenylalanine level within this group was 149 ±134 μmol/l (p<0.001).
Croatian: Nakon 3 tjedna liječenja dozom od 20 mg/kg/dnevno sapropterindiklorida, koncentracije fenilalanina u krvi su se značajno smanjile; srednja vrijednost ± SD smanjenja od početne koncentracije fenilalanina u krvi za tu skupinu bilo je 149 ± 134 μmol/l (p<0,001).
English: The starting dose of Kuvan in adult and paediatric patients with BH4 deficiency is 2 to 5 mg/kg body weight total daily dose.
Croatian: Početna doza lijeka Kuvan kod odraslih i pedijatrijskih bolesnika s nedostatkom BH4 je 2 do 5 mg/kg tjelesne težine kao ukupna dnevna doza.
English: Pour the amount of water into the medicine cup, as instructed by your doctor (e.g. your doctor told you to use 20 ml for dissolving
Croatian: Natočite određenu količinu vode u čašicu za lijek, prema uputama Vašeg liječnika (npr. liječnik Vam je rekao da uporabite 20 ml za otapanje jedne tablete Kuvana).
English: Number of tablets to be dissolved (100 mg strength only)
Croatian: Broj tableta koje treba otopiti (samo jačina od 100 mg)
English: Ask your doctor for the medicine cup for dissolving the powder and the 10 ml or 20 ml oral syringe if you do not have these supplies.
Croatian: Zamolite liječnika da Vam da čašicu za lijek za otapanje praška i oralnu štrcaljku od 10 ml ili 20 ml, ako ih nemate.
English: To be dissolved before use.
Croatian: Prije uporabe otopiti.
English: Ask your doctor for the medicine cup for dissolving the tablets and the 10 ml or 20 ml oral syringe if you do not have these supplies.
Croatian: Zamolite liječnika da Vam da čašicu za lijek za otapanje tableta i oralnu štrcaljku od 10 ml ili 20 ml, ako ih nemate.
English: Caution must be exercised when prescribing to such patients.
Croatian: Potreban je oprez kod propisivanja lijeka Kuvan takvim bolesnicima.
English: Blood phenylalanine and tyrosine levels should be tested, particularly in the paediatric population, one to two weeks after each dose adjustment and monitored frequently thereafter, under the direction of the treating physician.
Croatian: Koncentraciju fenilalanina i tirozina u krvi potrebno je kontrolirati, posebno kod djece, tjedan ili dva nakon svakog prilagođavanja doze te provoditi česte kontrole nakon toga, u skladu s uputama nadležnog liječnika.
English: After dissolving the powder in water, the solution must be clear, colourless to yellow.
Croatian: Nakon što prašak otopite u vodi, otopina mora biti prozirna, bezbojna do žute boje.
English: Dosing for PKU
Croatian: Doziranje za fenilketonuriju (PKU)
English: For cleaning, the plunger should be removed from the barrel of the oral syringe.
Croatian: Pri čišćenju treba izvaditi klip iz tijela oralne štrcaljke.
English: Wash both parts of the oral syringe and the medicine cup with warm water and air dry.
Croatian: Isperite oba dijela oralne štrcaljke i čašicu za lijek toplom vodom i ostavite ih da se osuše na zraku.
English: Discard unused solution within 20 minutes for tablet solution.
Croatian: Baciti neiskorištenu otopinu tableta u roku od 20 minuta.