natgillin/translations-raw huggingface dataset:
Separation between ataluren and placebo was maintained from Week 16 through the end of the study.
Razlika med atalurenom in placebom se je ohranila od 16. tedna do konca študije.
- If you are allergic to ataluren or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na ataluren ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
As a precautionary measure, it is recommended to avoid the use of ataluren during pregnancy.
Kot previdnostni ukrep se priporoča izogibanje uporabi atalurena med nosečnostjo.
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
A risk to the breastfed new-borns/infants cannot be excluded.
Tveganja za dojene novorojenčke/dojenčke ni mogoče izključiti.
No effects on male and female fertility were observed, but effects of early juvenile treatment on fertility during adulthood were not investigated.
Učinkov na plodnost pri moških in ženskah niso opazili, vendar pa niso bili raziskani učinki zdravljenja v zgodnji mladosti na plodnost v odraslem obdobju.
Hypertension with use of concomitant systemic corticosteroids
Hipertenzija, povezana s sočasno uporabo sistemskih kortikosteroidov
The pharmacokinetics of ataluren has been evaluated in study PTC124-GD-030 over a duration of 4 weeks.
Farmakokinetiko atalurena so ovrednotili v študiji PTC124-GD-030, ki je trajala 4 tedne.
Higher ataluren exposure was associated with potential decrease in efficacy.
Večja izpostavljenost atalurenu je bila povezana s potencialnim zmanjšanjem učinkovitosti.
Description of selected adverse reactions (laboratory abnormalities)
Opis izbranih neželenih učinkov (laboratorijske nenormalnosti)
What you need to know before you take Translarna 3.
Kaj morate vedeti, preden boste vzeli zdravilo Translarna 3.
In a 48-week open-label extension study in patients with nmDMD patients who were ambulant or nonambulant demonstrated a similar safety profile.
V 48-tedenski odprti podaljšanji študiji pri bolnikih z nmDMD so bolniki, ki so bili pokretni ali nepokretni, kazali podoben varnostni profil.
Due to the low number of other races included in the clinical studies, no conclusions can be drawn on the effect of UGT1A9 in other ethnic groups.
Zaradi majhnega števila drugih ras, vključenih v klinične študije, ni mogoče podati nobenih zaključkov o vplivu UGT1A9 pri drugih etničnih skupinah.
Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Ireland
Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD
The onset of reduction in relative bioavailability is estimated to occur approximately 60 hours after the first dose.
Relativna biološka uporabnost se po ocenah začne zmanjševati približno 60 ur po prvem odmerku.
Remember to take the next dose on time.
Ne pozabite vzeti naslednjega odmerka ob pravem času.
Do not give this medicine to children under the age of 2 years or weighing less than 12 kg as it has not been tested in this group of patients.
Zdravilo se ne sme dajati otrokom, mlajšim od 2 let ali s telesno maso manj kot 12 kg, saj pri tej skupini bolnikov ni bilo preskušeno.
Patients who do not have a nonsense mutation
Bolniki brez nesmiselne mutacije
The safety and efficacy of Translarna in children <12kg and aged 6 months to 2 years have not yet been established.
Varnost in učinkovitost zdravila Translarna pri otrocih < 12 kg in starih od 6 mesecev do 2 let, še nista bili dokazani.
It is important to take the correct dose.
Pomembno je, da se daje pravilen odmerek.
This means that there is more evidence to come about this medicine.
To pomeni, da se pričakujejo dodatni dokazi o zdravilu.
Weight Range (kg)
Razpon telesne mase (kg)
The majority of patients in all treatment groups were Caucasian (90%).
Večina bolnikov v vseh skupinah, ki so prejemale zdravljenje, je bila belcev (90 %).
Tell your doctor if you are taking any of the following medicines:
Obvestite zdravnika, če jemljete katero koli od naslednjih zdravil: Zdravilo
Open the sachet only at the time you are taking the medicine and use the entire amount from the sachet.
Odprite vrečico šele takrat, ko boste vzeli zdravilo, in uporabite celotno vsebino vrečice.
The majority of patients in both treatment groups were Caucasian (76%).
Večina bolnikov v obeh skupinah, ki sta prejemali zdravljenje, je bila belcev (76 %).
Increasing the dose above the recommended dose may be associated with reduced effectiveness.
Dajanje odmerkov, večjih od priporočenih, je lahko povezano z manjšo učinkovitostjo.
Translarna is available in packs containing 30 sachets.
Zdravilo Translarna je na voljo v pakiranjih, ki vsebujejo 30 vrečic.
Do not use this medicine after the expiry date, which is stated on the carton and sachet after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečici poleg oznake "EXP".
In a 26-week transgenic mouse model for carcinogenicity, no evidence of carcinogenicity was found.
Pri transgenem mišjem modelu za proučevanje rakotvornosti po 26 tednih niso odkrili nobenih znakov rakotvornosti.
Females were not studied in nmDMD clinical trials.
Žensk v kliničnih preskušanjih pri bolnikih z nmDMD niso proučevali.
Time to 10% worsening in 6MWD was defined as the last time that 6MWD was not 10% worse than baseline.
Čas do 10-% poslabšanja v 6MWD je opredeljen kot zadnja časovna tička, ko 6MWD ni bila za 10 % slabša kot ob izhodišču.
Other medicines and Translarna
Druga zdravila in zdravilo Translarna
Pharmacotherapeutic group:Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX03
Farmakoterapevtska skupina: druga zdravila za zdravljenje bolezni mišično-skeletnega sistema, oznaka ATC: M09AX03
Co. Armagh BT63 5UA
Co. Armagh BT63 5UA Velika Britanija
In addition to the above mentioned effects, several other less adverse effects were found in the repeat dose studies; in particular decreased body weight gain, food intake and increased liver weight without a histological correlate and of unclear clinical significance.
Poleg zgoraj navedenih učinkov so v študijah s ponovljenimi odmerki opazili še več drugih manj škodljivih neželenih učinkov, zlasti zmanjšano pridobivanje telesne mase, zmanjšan vnos hrane ter povečano maso jeter brez histološke povezave in z nejasnim kliničnim pomenom.
Morning
Zjutraj
In vitro, ataluren is 99.6% bound to human plasma proteins and the binding is independent of plasma concentration.
In vitro se 99,6 % atalurena veže na človeške plazemske beljakovine, pri čemer vezava ni odvisna od plazemske koncentracije.
Translarna is used to treat patients aged 2 years and older, who are able to walk.
Zdravilo Translarna se uporablja za zdravljenje bolnikov, starih 2 let ali več, ki lahko hodijo.
Presence of radioactivity in pup plasma confirmed absorption from the milk by the pups.
Prisotnost radioaktivnosti v plazmi mladičev je potrdila absorpcijo iz mleka.
These results indicate that ataluren 40 mg/kg/day slows the loss of walking ability in nmDMD patients.
Ti rezultati kažejo, da ataluren 40 mg/kg/dan upočasni izgubo zmožnosti hoje pri bolnikih z nmDMD.
In the event of a suspected overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Ob sumu, da je prišlo do prevelikega odmerjanja, je treba zagotoviti podporno oskrbo, ki vključuje posvet z zdravstvenim delavcem in skrbno opazovanje kliničnega stanja bolnika.
Take Translarna by mouth 3 times per day; in the morning, midday and evening.
Zdravilo Translarna jemljite skozi usta 3-krat na dan, in sicer zjutraj, zgodaj popoldne in zvečer.
If you have any kidney problem, your doctor should check your kidney function regularly.
Če imate kakršne koli težave z ledvicami, mora zdravnik redno preverjati delovanje vaših ledvic.
It is hypothetised that the in vivo dose response relationship may also be bell-shaped, but in vivo data were too limited to confirm this hypothesis in a mouse model for nmDMD and in humans.
Domneva se, da bi lahko bila in vivo povezava med odmerkom in odzivom prav tako v obliki zvona, vendar pa so bili podatki in vivo preveč omejeni, da bi lahko potrdili to hipotezo pri mišjem modelu za nmDMD in pri človeku.
Safety data from 28 weeks of therapy showed a similar safety profile of ataluren in patients 2-5 years as compared with patients aged 5 years and older.
Podatki o varnosti iz 28-tedenskega zdravljenja so pokazali podoben profil varnosti atalurena za bolnike, stare od 2 do 5 let, v primerjavi z bolniki, starimi 5 in več let.
Patients who experience dizziness should use caution when driving, cycling or using machines.
Bolniki, pri katerih se pojavlja omotica, morajo biti pri vožnji, kolesarjenju ali upravljanju strojev previdni.
In both studies, 1/232 (0.43%) patients treated with ataluren discontinued due to an adverse reaction of constipation and 1/172 (0.58%) placebo patients discontinued treatment due to an adverse reaction of disease progression (loss of ambulation).
V obeh študijah je 1/232 (0,43 %) bolnikov, zdravljenih z atalurenom, prekinilo zdravljenje zaradi neželenega učinka konstipacije in 1/172 (0,58 %) bolnikov, ki so prejemali placebo, je prekinilo zdravljenje zaradi neželenega učinka napredovanja bolezni (izguba mobilnosti).
Ataluren plasma concentrations in patients from 2 to less than 5 years old were consistent with those seen in patients above the age of 5 years receiving the 10/10/20 mg/kg dose regimen.
Koncentracije atalurena v plazmi bolnikov, starih od 2 do manj kot 5 let, so bile skladne z vrednostmi, ki so jih videli pri bolnikih, starih več kot 5 let, ki so prejemali režim odmerjanja 10/10/20 mg/kg.
adefovir treatment of chronic hepatitis B and/or HIV
Običajno se predpiše za aciklovir zdravljenje noric adefovir zdravljenje kroničnega hepatitisa B in/ali virusa HIV
But, take the next doses on time.
Naslednje odmerke vzemite ob pravem času.
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
A standard package of reproduction toxicity studies was available.
Na voljo so bile standardne študije o vplivu na sposobnost razmnoževanja.
No serious adverse reactions were observed in these subjects.
Resnih neželenih učinkov pri teh osebah niso opazili.
Study 2 evaluated 230 male patients, ages 7 to 14 years.
V študiji 2 so ocenili 230 moških bolnikov, starih od 7 do 14 let.
Percent Not 10% Worsened
Odstotek brez 10-odstotnega poslabšanja
TRANSLARNA 10 mg/kg, 10 mg/kg, 20 mg/kg (N=57) Placebo (N=57)
TRANSLARNA 10, 10, 20 mg/kg (n = 57) placebo (n = 57)
What Translarna is and what it is used for
Kaj je zdravilo Translarna in za kaj ga uporabljamo
A lower ataluren dose should be considered.
Razmisliti je treba o nižjem odmerku atalurena.
Magnesium stearate
magnezijev stearat
Your dose of Translarna depends on your body weight.
Odmerek zdravila Translarna, ki ga boste jemali, bo odvisen od vaše telesne mase.
If you have severe kidney problems (eGFR <30 ml/min) or if you are receiving dialisys because your kidneys do not work (end-stage renal disease) your doctor will established if treatment with Translarna is suitable for you.
Če imate hude težave z ledvicami (eGFR < 30 ml/min) ali če se zdravite z dializo, ker vaše ledvice ne delujejo (končna stopnja ledvične odpovedi), bo vaš zdravnik presodil, če je zdravljenje z zdravilom
Kaplan-Meier Curve of Time to Persistent 10% 6MWD Worsening (Study 1)
Kaplan-Meierjeva krivulja časa do persistentnega 10-odstotnega poslabšanja 6MWD
It is unknown whether ataluren/metabolites are excreted in human milk.
Ni znano, ali se ataluren/presnovki izločajo v materino mleko.
Based on data in healthy volunteers, the relative bioavailability of ataluren is approximately 40% lower at steady-state than after the initial dose.
Glede na podatke, pridobljene pri zdravih prostovoljcih, je relativna biološka uporabnost atalurena v stanju dinamičnega ravnovesja za približno 40 % manjša kot po začetnem odmerku.
In addition, at exposure much higher than in patients an increase of (rare) urinary bladder tumours was found.
Poleg tega so pri izpostavljenosti, ki je bila veliko večja kot pri bolnikih, odkrili povečano število (redkih) tumorjev sečnega mehurja.
In addition, one case of malignant hibernoma was found at the highest dose in a 2-year rat carcinogenicity study.
Poleg tega so en primer malignega hibernoma odkrili tudi pri največjem odmerku v 2-letni študiji rakotvornosti pri podganah.
One out of two 26-week rat repeat dose studies, initiated in 4-5 weeks old rats, showed a dose related increase of the incidence of malignant hibernoma, a rare tumour in rats.
Ena od dveh 26-tedenskih študij s ponavljajočimi odmerki pri podganah, ki so jo začeli pri podganah, starih od 4-5 tednov, je pokazala z odmerkom povezano povečanje incidence malignega hibernoma, sicer redkega tumorja pri podganah.
Patients were randomised in a 1:1 ratio and received ataluren 40 mg/kg/day (n=115) or placebo (n=115) 3 times per day (morning, midday, and evening).
Bolniki so bili randomizirani v razmerju 1 : 1 in so prejemali ataluren 40 mg/kg/dan (n = 115) ali placebo (n = 115) 3-krat na dan (zjutraj, popoldne in zvečer).
Study 1 evaluated 174 male patients, ages 5 to 20 years.
V študiji 1 so ocenili 174 moških bolnikov, starih od 5 do 20 let.
The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged >5years.
Učinkovitost zdravila Translarna pri otrocih, starih od 2 do 5 let, je bila dokazana z ekstrapolacijo z bolnikov, starih > 5 let.
An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
The toxicity of the metabolite is unknown.
Toksičnost presnovka ni znana.
The primary efficacy endpoint in both trials was change in 6 Minute Walk Distance (6MWD) at Week 48.
Primarni opazovani dogodek učinkovitosti v obeh preskušanjih je bila sprememba v razdalji, prehojeni v 6 minutah (6MWD, 6 Minute Walk Distance) v 48. tednu.
Very common side effects (may affect more than 1 in 10 people): - Vomiting
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - bruhanje.
Although ataluren is practically insoluble in water, ataluren is readily absorbed after oral administration as a suspension.
Čeprav je ataluren skoraj netopen v vodi, se po peroralnem dajanju v obliki suspenzije zlahka absorbira.
Efficacy has not been demonstrated in non-ambulatory patients.
Učinkovitost pri imobilnih bolnikih ni bila dokazana.
In a statistical based model the estimated mean difference was 13.0 meters (p=0.213), Figure 4.
V statističnem modelu je bila ocenjena povprečna razlika 13,0 metra (p = 0,213), slika 4.
Treatment with Translarna should only be initiated by specialist physicians with experience in the management of Duchenne/Becker muscular dystrophy.
Zdravljenje z zdravilom Translarna sme uvesti samo zdravnik specialist, ki ima izkušnje z zdravljenjem Duchennove/Beckerjeve mišične distrofije.
These data indicate no apparent drug-drug interaction between corticosteroids and ataluren, and no dose adjustments are required.
Ti podatki kažejo, da ne prihaja do opaznega medsebojnega delovanja kortikosteroidov in atalurena, zato prilagajanje odmerkov ni potrebno.
In a 2-year rat carcinogenicity study, one case of hibernoma was found.
V 2-letni študiji rakotvornosti pri podganah so odkrili en primer hibernoma.
Take each prepared dose immediately after preparation.
Posamezen pripravljen odmerek vzemite takoj po pripravi.
The safety and efficacy of ataluren in patients aged 65 and older have not yet been established (see section 5.2).
Starejši Varnost in učinkovitost atalurena pri bolnikih, starih 65 let ali več, še nista bili dokazani (glejte poglavje 5.2).
Potential interactions with other medicinal products
Morebitno medsebojno delovanje z drugimi zdravili
Healthy volunteers receiving a single oral dose of 200 mg/kg of ataluren experienced transient, low-grade symptoms of headache, nausea, vomiting, and diarrhoea.
Pri zdravih prostovoljcih, ki so prejeli enkratni peroralni odmerek atalurena 200 mg/kg, so se pojavili prehodni blažji simptomi, med katerimi so bili glavobol, slabost, bruhanje in driska.
The safety, pharmacokinetics and exploratory effectiveness of Translarna were assessed in an openlabel study in children between 2 and 5 years of age with nmDMD.
Pediatrična populacija Varnost, farmakokinetiko in raziskovalno učinkovitost zdravila Translarna so ocenili v odprti študiji z otroki, starimi od 2 do 5 let, z nmDMD.
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products (eg oseltamivir, aciclovir, captopril, furosemide, bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
Zato je pri sočasni uporabi atalurena z zdravili, ki so substrati OAT1 ali OATP1B3, potrebna previdnost, saj obstaja tveganje za zvišane koncentracije teh zdravil (to so npr. oseltamivir, aciklovir, kaptopril, furosemid, bumetanid, valsartan, pravastatin, rosuvastatin, atorvastatin in pitavastatin).
For example, you might take Translarna at 7:00 AM in the morning with breakfast, at 1:00 PM in the afternoon with lunch, and again at around 7:00 PM in the evening with dinner.
Na primer: zdravilo Translarna lahko vzamete ob 7. uri zjutraj med zajtrkom, ob 13. uri popoldan med kosilom in nato še okoli 19. ure zvečer med večerjo.
An open-label study was performed including patients aged 2-5 years (n=14) to evaluate the PK and safety of ataluren.
Izvedli so odprto študijo, v katero so bili vključeni bolniki, stari od 2 do 5 let (n = 14) za ovrednotenje farmakokinetike in varnosti atalurena.
Your doctor will test the levels of lipids (fats such as cholesterol and triglycerides) in your blood and your kidney function every 6 to 12 months.
Zdravnik bo vsakih 6 do 12 mesecev preveril ravni lipidov (maščob, kot so holesterol in trigliceridi) v vaši krvi ter delovanje vaših ledvic.
In the ITT population, the hazard ratio for ataluren versus placebo was 0.75 (p=0.160), representing a 25% reduction in the risk of 10% 6MWD worsening.
V populaciji ITT je bilo razmerje tveganja za ataluren v primerjavi s placebom 0,75 (p = 0,160), kar predstavlja 25-% zmanjšanje tveganja za 10-% poslabšanje v 6MWD.
Changes in lipid profile
Spremembe ravni lipidov
The most common adverse reactions in the 2 placebo-controlled studies were vomiting, diarrhoea, nausea, headache, upper abdominal pain, and flatulence, all occurring in ≥5% of all ataluren-treated patients.
Najpogostejši neželeni učinki v 2 s placebom kontroliranih študijah so bili bruhanje, driska, navzea, glavobol, bolečine v zgornjem delu trebuha in flatulenca, ki so se vsi pojavili pri ≥ 5 % bolnikov, zdravljenih z atalurenom.
If you forget to take Translarna
Če ste pozabili vzeti zdravilo Translarna
Therefore, if treatment with intravenous aminoglycosides is necessary the treatment with Translarna should be stopped and can be resumed 2 days after administration of the aminoglycoside has ended.
Če je torej potrebno zdravljenje z aminoglikozidi za intravensko uporabo, je treba zdravljenje z zdravilom Translarna prekiniti, ponovno pa se lahko uvede dva dneva po koncu uporabe aminoglikozidov.
- If you are receiving treatment with certain antibiotics, such as gentamicin, tobramycin, or streptomycin by injection into a vein.
- če prejemate zdravljenje z določenimi antibiotiki, kot so gentamicin, tobramicin ali streptomicin, ki se dajejo z injiciranjem v veno.
Background incidence of this tumour type in rats as well as humans is very low and the mechanism causing these tumours in the rat studies (including its relation to ataluren treatment) is unknown.
Izkušnje kažejo, da je incidenca te vrste tumorja pri podganah in pri ljudeh zelo majhna, mehanizem, ki je v študijah pri podganah povzročil omenjene tumorje, pa ni znan (niti njegova povezava s prejemanjem atalurena).
Since the mechanism by which ataluren increases nephrotoxicity of intravenous aminoglycosides is not known, concomitant use of other nephrotoxic medicinal products with ataluren is not recommended.
Ker mehanizem, preko katerega ataluren poveča nefrotoksičnost aminoglikozidov za intravensko uporabo, ni znan, sočasna uporaba drugih nefrotoksičnih zdravil in atalurena ni priporočljiva.
Therefore, patients with severe renal impairment or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk, and should be closely monitored for possible metabolite toxicity and decrease in efficacy.
Zato je treba bolnike s hudo okvaro ledvic ali končno odpovedjo ledvic zdraviti z atalurenom le, če pričakovane klinične koristi pretehtajo tveganje, in treba jih je skrbno spremljati glede potencialne toksičnosti presnovka in zmanjšanja učinkovitosti.
There are no adequate data from the use of ataluren in pregnant women.
O uporabi atalurena pri nosečnicah ni zadostnih podatkov.
The prepared dose should be mixed well before administration.
Pripravljen odmerek je treba pred dajanjem dobro premešati.
Concomitant use of intravenous aminoglycosides (see sections 4.4 and 4.5).
Sočasna uporaba aminoglikozidov za intravensko uporabo (glejte poglavji 4.4 in 4.5).
Sachets should only be opened at the time of dose preparation.
Vrečice se lahko odprejo šele takrat, ko je čas za pripravo odmerka.
Based on a pharmacokinetic assessment conducted in groups with either mild, moderate or severe hepatic impairment versus a control group of healthy subjects, no dose adjustment is required for patients with any degree of hepatic impairment.
Na podlagi farmakokinetične ocene, izvedene v skupinah z blagimi, zmernimi ali hudimi okvarami jeter v primerjavi s kontrolno skupino zdravih preiskovancev, prilagajanje odmerka pri bolnikih z nobeno stopnjo okvare jeter ni potrebno.
Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9, or substrates of OAT1 or OAT3 (see section 4.5).
Previdnost je potrebna, kadar se ataluren uporablja sočasno z zdravili, ki so induktorji UGT1A9 ali substrati OAT1 ali OAT3 (glejte poglavje 4.5).
Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Sočasna uporaba atalurena in kortikosteroidov (deflazakorta, prednizona ali prednizolona) ni vplivala na koncentracije atalurena v plazmi.
The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing (see section 4.4).
Prisotnost nesmiselne mutacije gena za distrofin je treba potrditi z genetskimi preiskavami (glejte poglavje 4.4).