FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Dysphonia, epistaxis, nasal congestion, oropharyngeal pain, throat irritation
Slovenian: Disfonija, epistaksa, zamašenost nosu, bolečine v žrelu, draženje grla
English: The RAVICTI pack contains the medicinal product and a reclosable bottle cap adapter.
Slovenian: Pakiranje zdravila RAVICTI vsebuje zdravilo in zamašek z nastavkom za brizgo.
English: • gallbladder, bladder or back pain
Slovenian: • bolečine v žolčniku, sečnem mehurju ali hrbtu
English: RAVICTI must be used with a special low protein diet. - This diet will be designed for you by your doctor and dietician.
Slovenian: - To dieto bosta posebej za vas pripravila vaš zdravnik in dietetik.
English: Store bottle and oral syringe in a clean, dry place between doses.
Slovenian: Med posameznimi odmerjanji stekenico shranite na čistem in suhem mestu.
English: The median exposure was 10 months (range 2 to 20 months) and median exposure in the 2 months to less than 2 years of age was 9 months (range 0.2 to 20.3 months).Adverse drug reactions (ADR) are summarized below.
Slovenian: Mediana izpostavljenost je bila 10 mesecev (razpon 2 do 20 mesecev), medtem ko je bila mediana izpostavljenost za starost od 2 mesecev do manj kot 2 leti 9 mesecev
English: • 7000 microgram (mcg/ml) for patients >2 years of age with a BSA of ≤1.3
Slovenian: • 7000 mikrogramov (μg/ml) za bolnike starosti >2 let s telesno površino ≤1,3
English: Swallow the liquid from the oral syringe or attach the oral syringe to a gastrostomy or nasogastric tube.
Slovenian: Pogoltnite tekočino iz peroralne brizge ali pritrdite peroralno brizgo na gastrostomo ali nazogastrično sondo.
English: Respiratory, thoracic and mediastinal disorder
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: • 5000 microgram (mcg/ml) for patients >2 years of age with a BSA of >1.3
Slovenian: • 5000 mikrogramov (μg/ml) za bolnike starosti >2 let s telesno površino >1,3
English: Mean maximum concentration (Cmax) for PBA, PAA, and PAGN was 37.0 micrograms/ml, 14.9 micrograms/ml, and 30.2 micrograms/ml, respectively.
Slovenian: Srednje vrednosti najvišje koncentracije (Cmax) za PBA, PAA in PAGN so bile 37,0 mikrogramov/ml,
English: In the pooled analysis of the short-term studies in children (Study 3 and Study 4), plasma ammonia was significantly lower after switching to glycerol phenylbutyrate; ammonia AUC0-24h was 626.79 and 871.72 (micromol/L)*hour during treatment with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 26, ratio of geometric means 0.79; 95% confidence intervals 0.647, 0.955).
Slovenian: V analizi združenih podatkov iz kratkoročnih študij pri otrocih (3. študija in 4. študija) je bila plazemska koncentracija amoniaka pomembno nižja po prehodu na glicerol fenilbutirat; površina pod krivuljo plazemskih koncentracij amoniaka (AUC0-24h) je bila 626,79 [(mikromol/l)*h ] med zdravljenjem z glicerol fenilbutiratom in in 871,72 med zdravljenjem natrijevim fenilbutiratom (n = 26, razmerje geometričnih sredin 0,79; 95-odstotni intervali zaupanja 0,647, 0,955).
English: Upon oral ingestion, PBA is released from the glycerol backbone in the gastrointestinal tract by pancreatic lipases.
Slovenian: Po peroralnem zaužitju se PBA sprosti z osnove glicerola v prebavni trakt s pomočjo pankreatične lipaze.
English: • Utilising the plunger of the oral syringe, administer RAVICTI into the tube.
Slovenian: • Z uporabo bata peroralne brizge aplicirajte zdravilo RAVICTI v sondo.
English: Glycerol phenylbutyrate is a nitrogen-binding medicinal product.
Slovenian: Glicerol fenilbutirat je zdravilo, ki veže nase dušik.
English: CE marked oral syringes compatible with the reclosable bottle cap adapter can be obtained from a pharmacy.
Slovenian: Peroralne brizge z oznako CE, ki so združljive z zamaškom z nastavkom za brizgo, so na voljo v lekarni.
English: It is not recommended to administer a dose of 0.5 ml or less with nasogastric, gastrostomy or nasojejunal tubes, given the low drug recovery in dosing.
Slovenian: Apliciranje odmerka 0,5 ml ali manj preko nazogastrične sonde, gastrostome ali nazojejunalne sonde ni priporočljivo zaradi nizkega odstotka izkoriščenega zdravila pri takem odmerjanju.
English: Constipation, Flatulence, Gastrooesophageal reflux disease
Slovenian: Konstipacija, flatulenca, gastrooezofagealna refluksna bolezen vsaka po 1 (6,3 %)
English: The daily dose should be individually adjusted according to the patient's estimated urea synthetic capacity, if any, protein tolerance and the daily dietary protein intake needed to promote growth and development.
Slovenian: Dnevni odmerek je treba individualno prilagajati glede na bolnikovo ocenjeno sposobnost sinteze sečnine, v kolikor do sinteze sploh prihaja, tolerance na beljakovine in dnevni vnos prehranskih beljakovin, ki so potrebne za pospeševanje rasti in razvoja.
English: • If you are pregnant, tell your doctor before you start taking RAVICTI.
Slovenian: Nosečnost, kontracepcija in dojenje • Če ste noseči, obvestite zdravnika, preden začnete jemati zdravilo RAVICTI.
English: Food aversion
Slovenian: Odklanjanje hrane
English: • You should not take RAVICTI if you are breast-feeding.
Slovenian: • Če dojite, ne smete jemati zdravila RAVICTI.
English: Although two patients had day 7 ammonia values of 150 micromol/L and 111 micromol/L respectively, neither had associated signs and symptoms of hyperammonemia.
Slovenian: Čeprav sta imela dva bolnika vrednosti amoniaka na 7. dan 150 mikromolov/l oz.
English: In the pooled analysis of studies where patients switched from sodium phenylbutyrate to glycerol phenylbutyrate, ammonia AUC0-24h was 774.11 and 991.19 [(micromol/L)*hour] during treatment with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 80, ratio of geometric means 0.84; 95% confidence intervals 0.740, 0.949).
Slovenian: Analiza združenih podatkov iz študij, kjer so bolniki prešli z natrijevega fenilbutirata na glicerol fenilbutirat, je bila površina pod krivuljo plazemskih koncentracij amoniaka (AUC0-24h) 774,11 [(mikromol/l)*h] med zdravljenjem z glicerol fenilbutiratom in in 991,19 med zdravljenjem z natrijevim fenilbutiratom (n = 80, razmerje geometričnih sredin 0,84; 95-odstotni interval zaupanja
English: The recommended dosages for patients naïve to phenylbutyric acid and for patients switching from sodium phenylbutyrate or from sodium phenylacetate/sodium benzoate injection to RAVICTI are different.
Slovenian: Priporočeni odmerki za bolnike, ki še niso prejemali fenilbutirične kisline, in za bolnike, ki so prešli z natrijevega fenilbutirata ali injekcij natrijevega fenilacetata/natrijevega benzoata na zdravilo
English: The mean normalized venous ammonia values in pediatric patients aged less than 2 months were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 35 to 94 micromol/L).
Slovenian: Povprečne normalizirane vrednosti amoniaka v venski krvi pri pediatričnih bolnikih, starih manj kot 2 meseca, so bile znotraj normalnih mej med dolgoročnim zdravljenjem z glicerol fenilbutiratom (razpon: 35 do 94 mikromolov/l).
English: RAVICTI 1.1 g/ml oral liquid
Slovenian: IME ZDRAVILA RAVICTI 1,1 g/ml peroralna tekočina
English: Skin and subcutaneous tissue disorders
Slovenian: Driska Bolezni kože in podkožja
English: • Place the tip of the oral syringe onto the tip of the gastrostomy/nasogastric tube.
Slovenian: • Položite vrh/konico peroralne brizge na vrh/konico gastrostome/nazogastrične sonde.
English: It is important to ensure that the oral syringe is kept clean and dry between the dosing intervals.
Slovenian: Ista peroralna brizga je namenjena za vse odmerke za vsak dan. Pomembno je zagotoviti, da peroralna brizga med odmernimi intervali ostane čista in suha.
English: Patients switching from sodium phenylbutyrate to RAVICTI should receive the dosage of RAVICTI that contains the same amount of phenylbutyric acid.
Slovenian: Začetni odmerek pri bolnikih, ki so prešli z natrijevega fenilbutirata na zdravilo RAVICTI: Bolniki, ki so prešli iz natrijevega fenilbutirata na zdravilo RAVICTI, morajo prejemati takšen odmerek zdravila RAVICTI, ki vsebuje isto količino fenilbutirične kisline.
English: • Each ml of liquid contains 1.1 g of glycerol phenylbutyrate.
Slovenian: • En ml tekočine vsebuje 1,1 g glicerol fenilbutirata.
English: Mean 24-hour AUCs for venous ammonia during steady-state dosing were 866 micromol/L*hour and 977 micromol/L*hour with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 44, ratio of geometric means 0.91; 95% confidence intervals 0.799, 1.034).
Slovenian: Povprečna vrednost AUC (0-24) za amoniak v venski krvi pri odmerjanju v stanju dinamičnega ravnovesja je bila 866 mikromol/l*h pri uporabi glicerol fenilbutirata in pri uporabi 977 mikromol/l*h natrijevega fenilbutirata (n = 44, razmerje geometričnih sredin 0,91; 95-odstotni interval zaupanja 0,799, 1,034).
English: Hyperammonemia may be induced by haloperidol and by valproic acid.
Slovenian: Valprojska kislina in haloperidol lahko sprožita hiperamoniemijo.
English: Do not rinse the reclosable bottle cap or the oral syringe between daily doses, as the presence of water causes glycerol phenylbutyrate to degrade.
Slovenian: Med dnevnimi odmerki ne spirajte zamaška z nastavkom za brizgo ali peroralne brizge, saj prisotnost vode povzroči razgradnjo glicerol fenilbutirata.
English: • by mouth
Slovenian: • peroralno (skozi usta)
English: Dizziness, headache, tremor Uncommon Dysgeusia, lethargy, paraesthesia, psychomotor hyperactivity, somnolence, speech disorder
Slovenian: Disgevzija, letargija, parestezija, psihomotorična hiperaktivnost,
English: Constipation Diarrhoea
Slovenian: Žilne bolezni
English: Preparation for nasogastric tube or gastrostomy tube administration: In vitro studies evaluating the percent recovery of total dose delivered with nasogastric, nasojejunal or gastrostomy tubes demonstrated the percent of dose recovered was > 99% for doses > 1 ml and 70% for a 0.5 ml dose.
Slovenian: Priprava za aplikacijo preko nazogastrične sonde ali gastrostome: Študije in vitro, ki so ocenjevale odstotek izkoriščenega skupnega odmerka, ki je bil apliciran preko nazogastrične sonde, nazojejunalne sonde ali gastrostome, so pokazale, da je bil odstotek izkoriščenega odmerka > 99 % za odmerke > 1 ml in približno 70 % za odmerek 0,5 ml. Bolniki, ki lahko pogoltnejo tekočino, morajo zaužiti zdravilo RAVICTI peroralno, to velja tudi za bolnike z nazogastrično sondo in/ali gastrostomo.
English: • stomach bloating or pain, constipation, diarrhoea, heartburn, wind, feeling sick (nausea), pain in the mouth, retching
Slovenian: • napihnjenost trebuha ali bolečina v trebuhu, zaprtje, driska, zgaga, vetrovi, siljenje na bruhanje
English: 1 (6.3%) each
Slovenian: Anemija, trombocitoza vsaka po 1 (6,3 %)
English: Mean fasting venous ammonia values were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 17-25 micromol/L).
Slovenian: Povprečne ravni amoniaka v krvi na tešče so bile znotraj normalnih vrednosti v času dolgoročnega zdravljenja z glicerol fenilbutiratom (razpon: 17-25 mikromol/l).
English: Flatulence, diarrhoea, vomiting, nausea, abdominal pain, dyspepsia, abdominal distension, constipation, oral discomfort, retching
Slovenian: Flatulenca, driska, bruhanje, slabost, bolečina v trebuhu, dispepsija, napet trebuh, zaprtje, nelagodje v ustih, bljuvanje
English: Important note: Do not rinse the reclosable bottle cap adapter or the oral syringe between daily doses as the introduction of water causes glycerol phenylbutyrate to degrade.
Slovenian: Pomembno opozorilo: Ne spirajte zamaška z nastavkom za brizgo ali peroralne brizge med posameznimi dnevnimi odmerki, ker dodatek vode povzroči razpad glicerol fenilbutirata.
English: Glycerol phenylbutyrate was non-inferior to sodium phenylbutyrate with respect to the 24-hour AUC for ammonia.
Slovenian: Glicerol fenilbutirat ni bil slabši kot natrijev fenilbutirat glede na površino pod krivuljo plazemskih koncentracij amoniaka v 24 urah.
English: Anaemia, Thrombocytosis
Slovenian: Hipoalbuminemija, hipokaliemija
English: The following side effects have been observed in a clinical study including 16 patients less than 2 months of age:
Slovenian: V klinični študiji, v katero je bilo vključenih 16 bolnikov, starih manj kot 2 meseca, so opazili naslednje neželene učinke:
English: Mean fasting venous ammonia values in adults in Study 2 were within normal limits during long-term treatment with glycerol phenylbutyrate (range: 630 micromol/L).
Slovenian: Povprečne ravni amoniaka v krvi na tešče pri odraslih v 2. študiji so bile znotraj normalnih vrednosti v času dolgoročnega zdravljenja z glicerol fenilbutiratom (razpon: 6-30 mikromol/l).
English: • changes in taste
Slovenian: • spremembe okusa • težave s sluhom
English: Mean venous ammonia values in paediatric patients in Study 5 were within normal limits during long-term (24 months) treatment with glycerol phenylbutyrate (range: 1525 micromol/L).
Slovenian: Povprečne vrednosti amoniaka v venski krvi pri pediatričnih bolnikih v Študiji 5 so bile med dolgoročnim (24-mesečnim) zdravljenjem z glicerol fenilbutiratom znotraj normalnih mej (razpon: 15-25 mikromolov/l).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3) Podatki o uporabi glicerol fenilbutirata pri nosečnicah so omejeni.
English: The reclosable bottle cap adapter can be used until the bottle is empty.
Slovenian: Zamašek z nastavkom za brizgo je treba zavreči, ko je steklenica prazna.
English: ‘gastrostomy tube'
Slovenian: Okvara ledvic
English: If you become pregnant while taking RAVICTI, talk to your doctor.
Slovenian: Če zanosite v času jemanja zdravila RAVICTI, se pogovorite z zdravnikom, ker to zdravilo lahko škoduje vašemu nerojenemu otroku.
English: Decreased appetite, increased appetite Uncommon Hypoalbuminaemia, hypokalaemia
Slovenian: Zmanjšan apetit, povečan apetit
English: • Step 2: 50% dose sodium phenylacetate/sodium benzoate and 100% RAVICTI for 4-8 hours;
Slovenian: 50-% odmerek natrijevega fenilacetata/natrijevega benzoata in 100-% zdravila
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Do not drive or use machines whilst experiencing these side effects.
Slovenian: Če opazite te neželene učinke, ne vozite in ne upravljajte s stroji.
English: • swelling of the hands and feet
Slovenian: • otekanje rok in nog
English: Other medicines and RAVICTI
Slovenian: Shranjevanje zdravila RAVICTI
English: Ammonia levels must be monitored closely when changing the dose of glycerol phenylbutyrate.
Slovenian: Kadar spremenite odmerek glicerol fenilbutirata, je treba skrbno nadzirati ravni amoniaka.
English: Recommended starting dosage in phenylbutyrate-naïve patients:
Slovenian: Priporočeni začetni odmerek pri bolnikih, ki še niso prejemali fenilbutirata:
English: The ratio of mean values for PAA to PAGN among all patients dosed with 6 ml BID ranged from 0.96 to 1.28 and for patients dosed with 9 ml twice daily ranged from 1.18-3.19.After multiple doses, a PAA concentration >200 mcg/L was associated with a ratio of plasma PAA to PAGN concentrations higher than 2.5.
Slovenian: Razmerje med povprečnimi vrednostmi PAA in PAGN med vsemi bolniki z odmerkom 6 ml dvakrat na dan je bilo od 0,96 do 1,28, pri bolnikih z odmerkom 9 ml dvakrat na dan pa od 1,18 do 3,19.
English: Monitoring and laboratory tests
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Oral liquid.
Slovenian: moksifloksacina.
English: ADRs in patients less than 2 months of age
Slovenian: Neželeni učinki pri bolnikih, starih manj kot 2 meseca
English: ADRs in patients 2 months to less than 2 years of age
Slovenian: Neželeni učinki zdravila pri bolnikih, starih manj kot 2 meseca do 2 let
English: Tell your doctor or go to the hospital straight away if you notice any of these signs.
Slovenian: Če opazite katerega koli od teh znakov, se pogovorite s svojim zdravnikom ali nemudoma poiščite pomoč v najbližji bolnišnici.
English: • if you have problems with your kidneys or liver - this is because glycerol phenylbutyrate is removed from your body through the kidneys and liver
Slovenian: Pred začetkom jemanja zdravila RAVICTI se posvetujte z zdravnikom ali farmacevtom: • če imate težave z ledvicami ali jetri - glicerol fenilbutirat se namreč izloča iz telesa preko jeter in ledvic.
English: Abnormal skin odour, acne Uncommon Alopecia, hyperhidrosis, pruritic rash
Slovenian: Alopecija, hiperhidroza, pruritični izpuščaj
English: You must follow a special low protein diet during treatment with glycerol phenylbutyrate.
Slovenian: V času zdravljenja z glicerol fenilbutiratom morate upoštevati posebno dieto z malo beljakovinami.
English: Uncommon Gallbladder pain
Slovenian: Bolečine v sečnem mehurju
English: Tell your doctor or pharmacist if you notice any of the following side effects:
Slovenian: Obvestite zdravnika ali farmacevta, če opazite katerega koli od navedenih neželenih učinkov: Pogosti: lahko se pojavijo pri največ 1 od 10 bolnikov
English: A total of 16 paediatric patients with UCDs aged less than 2 months participated in a long-term (24 months), uncontrolled, open-label study, of which 10 patients converted from sodium phenylbutyrate to RAVICTI.
Slovenian: Skupaj 10 pediatričnih bolnikov z UCD, starih 2 meseca do manj kot 2 leti, je sodelovalo v dolgoročni (24-mesečni), nenadzorovani, odprti študiji.
English: Eczema Nail ridging Rash
Slovenian: Lakota, pireksija
English: continued according to feeding schedule for 4-8 hours.
Slovenian: prekinitev uporabe natrijevega fenilacetata/natrijevega benzoata in polni odmerek zdravila RAVICTI, ki se nadaljuje v skladu z načrtom prehranjevanja za 4-8 ur.
English: Gastrointestinal disorders
Slovenian: peroralna ali gastroenteralna uporaba
English: Tightly close the tethered tab on the reclosable bottle adapter after use.
Slovenian: Po uporabi tesno zaprite pritrjeni jeziček na zamašku z nastavkom za brizgo.
English: Each ml of liquid contains 1.1g of glycerol phenylbutyrate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml tekočine vsebuje 1,1 g glicerol fenilbutirata.
English: Hay-on-Wye
Slovenian: Hay-on-Wye Hereford Herefordshire HR3 5PG
English: Place the tip of the oral syringe into the reclosable bottle cap adapter.
Slovenian: Konico peroralne brizge vstavite v zamašek z nastavkom za brizgo.
English: Uncommon Gastrointestinal viral infection
Slovenian: Virusna okužba prebavil
English: respectively.
Slovenian: Občasni
English: 1 reclosable bottle cap adapter.
Slovenian: Na steklenico privijte zamašek z nastavkom za brizgo.
English: Kuvan is taken with a meal at the same time every day, preferably in the morning.
Slovenian: Zdravilo Kuvan se vzame z obrokom vsak dan ob istem času, po možnosti zjutraj.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kuvan on 2 December 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Kuvan, veljavno po vsej Evropski uniji, izdala dne 2. decembra 2008.
English: What measures are being taken to ensure the safe and effective use of Kuvan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kuvan?
English: If this has been achieved after one month, the patient is classified as a ‘responder' and can continue taking Kuvan.
Slovenian: Če je to stanje doseženo po enem mesecu, se bolnik oceni kot odziven in lahko še naprej jemlje zdravilo.
English: Other information about Kuvan
Slovenian: Druge informacije o zdravilu Kuvan
English: Kuvan is intended for long-term use.
Slovenian: Zdravilo je namenjeno dolgotrajni uporabi.
English: For the treatment of BH4 deficiency, which is a very rare condition, the company presented results of three studies from the published literature in which some patients were treated with sapropterin for an average of 15.5 months.
Slovenian: Pri zdravljenju pomanjkanja BH4, zelo redke bolezni, je družba predstavila rezultate treh študij iz objavljene literature, v katerih so nekatere bolnike zdravili s sapropterinom povprečno 15,5 meseca.
English: Studies with Kuvan involved adults and children of all ages.
Slovenian: V študije zdravila Kuvan so bili vključeni odrasli in otroci vseh starosti.
English: What benefits of Kuvan have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Kuvan izkazalo v študijah?
English: It is not intended to provide practical advice on how to use Kuvan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Kuvan is available as soluble tablets (100 mg) or as powder (100 or 500 mg), to be dissolved in water and drunk.
Slovenian: Zdravilo Kuvan je na voljo v obliki topljivih tablet (100 mg) ali praška (100 mg ali 500 mg), ki se raztopijo v vodi in popijejo.
English: A satisfactory response is defined as a reduction in blood phenylalanine levels of at least 30% or to a level determined by the doctor.
Slovenian: Zadovoljiv odziv je opredeljen kot vsaj 30-odstotno znižanje ravni fenilalanina v krvi ali znižanje na raven, ki jo določi zdravnik.
English: What is Kuvan and what is it used for?
Slovenian: Kaj je zdravilo Kuvan in za kaj se uporablja?
English: The Agency decided that Kuvan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Agencija je zaključila, da so koristi zdravila Kuvan večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Kuvan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Kuvan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: This is a summary of the European public assessment report (EPAR) for Kuvan.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kuvan.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kuvan have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kuvan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What are the risks associated with Kuvan?
Slovenian: Kakšna tveganja so povezana z zdravilom Kuvan?
English: The most common side effects with Kuvan (seen in more than 1 patient in 10) are headache and rhinorrhoea (runny nose).
Slovenian: Najpogostejša neželena učinka zdravila Kuvan (opažena pri več kot 1 bolniku od 10) sta glavobol in rinoreja (izcedek iz nosu).
English: Why is Kuvan approved?
Slovenian: Zakaj je bilo zdravilo Kuvan odobreno?
English: For more information about treatment with Kuvan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kuvan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Kuvan sapropterin dihydrochloride
Slovenian: Kuvan sapropterinijev dihidroklorid
English: In these studies, patients showed an improvement in blood phenylalanine levels and other markers of the disease when they were taking the medicine.
Slovenian: V teh študijah je bilo pri bolnikih opaženo izboljšanje ravni fenilalanina v krvi in drugih označevalcev bolezni, če so jemali zdravilo.