FrancophonIA/ELRC3.0 huggingface dataset:
English: Ryzodeg was given once a day at mealtime with insulin aspart given at other mealtimes and this treatment was compared with treatment comprising insulin detemir given once or twice a day with insulin aspart given at all mealtimes.
Slovenian: Zdravilo so dajali enkrat na dan ob obroku, pri drugih obrokih pa insulin aspart, in to zdravljenje primerjali z zdravljenjem z insulinom detemirom, ki so ga dajali enkrat ali dvakrat na dan, pri vseh obrokih pa tudi insulin aspart.
English: Ryzodeg has also been studied in one main study in 362 children aged between 1 and 17 years with type 1 diabetes.
Slovenian: Zdravilo Ryzodeg so proučevali tudi v eni glavni študiji pri 362 otrocih s sladkorno boleznijo tipa 1, starih od 1 do 17 let .
English: In the studies in type 1 diabetes, patients also received injections of rapid acting insulin at other mealtimes.
Slovenian: V študijah pri sladkorni bolezni tipa 1 so bolniki prejemali tudi injekcije hitrodelujočega insulina ob preostalih obrokih.
English: Ryzodeg is a medicine that contains the active substances insulin degludec and insulin aspart.
Slovenian: Ryzodeg je zdravilo, ki vsebuje zdravilni učinkovini insulin degludek in insulin aspart.
English: The studies compared Ryzodeg given at mealtimes with insulin glargine or insulin detemir (long-acting insulins), or with biphasic insulin (an insulin formulation consisting of a mixture of intermediate- and rapid-acting insulin).
Slovenian: V študijah so zdravilo Ryzodeg, ki se ga daje ob obrokih, primerjali z insulinom glarginom ali insulinom detemirom (insulinoma z dolgotrajnim delovanjem) ali z dvofaznim insulinom (insulinom, sestavljenim iz kombinacije insulina s srednje dolgim in hitrim delovanjem).
English: How does Ryzodeg work?
Slovenian: Kako zdravilo Ryzodeg deluje?
English: What is Ryzodeg used for?
Slovenian: Za kaj se zdravilo Ryzodeg uporablja?
English: In type 1 diabetes, Ryzodeg is used with rapid-acting insulin, which is injected at other mealtimes.
Slovenian: Pri sladkorni bolezni tipa 1 se zdravilo Ryzodeg uporablja v kombinaciji s hitrodelujočim insulinom, ki se ga injicira ob preostalih obrokih.
English: How has Ryzodeg been studied?
Slovenian: Kako je bilo zdravilo Ryzodeg raziskano?
English: How is Ryzodeg used?
Slovenian: Kako se zdravilo Ryzodeg uporablja?
English: What is Ryzodeg?
Slovenian: Kaj je zdravilo Ryzodeg?
English: The studies in adults showed that Ryzodeg was at least as effective as long-acting insulins and biphasic insulin in controlling blood glucose levels in patients with type 1 and type 2 diabetes.
Slovenian: Študije so pokazale, da je bilo zdravilo Ryzodeg pri uravnavanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 1 in 2 vsaj tako učinkovito kot dolgodelujoči insulini in dvofazni insulin.
English: The CHMP concluded that Ryzodeg is effective in controlling blood glucose levels in adults, adolescents and children aged over 2 years with diabetes.
Slovenian: CHMP je zaključil, da je zdravilo Ryzodeg učinkovito pri uravnavanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 1 in 2.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: Jakost Farmacevtska oblika
English: However, these conditions are reported more frequently in the younger children in general.
Slovenian: Vendar pa o teh stanjih na splošno pogosteje poročajo pri mlajših otrocih.
English: Date of first authorisation: 31 July 2014 Date of latest renewal: 19 July 2018
Slovenian: Datum prve odobritve: 31. julij 2014 Datum zadnjega podaljšanja: 19. julij 2018
English: Long term safety data is not available.
Slovenian: Dolgoročni podatki o varnosti niso na voljo.
English: There have been cases reported where this increase to abnormal high values was already observed after 4 weeks.
Slovenian: Poročali so o primerih, kjer so to povečanje na nenormalno velike vrednosti opazili že po 4 tednih.
English: This effect is considered clinically not relevant.
Slovenian: Ta učinek ne velja za klinično pomembnega.
English: Patients should take the entire dose.
Slovenian: Bolniki morajo vzeti celoten odmerek.
English: Ataluren does not distribute into red blood cells.
Slovenian: Ataluren se ne porazdeli v rdeče krvne celice.
English: Final study report to be submitted Due date:
Slovenian: Končno poročilo o študiji bo oddano do roka:
English: Characteristic in specific groups of subjects or patients
Slovenian: Značilnosti pri posebnih skupinah oseb ali bolnikov
English: Frequency not known
Slovenian: Pogostnost ni znana
English: Ataluren should be administered orally every day in 3 doses.
Slovenian: Ataluren je treba dajati peroralno vsak dan v 3 odmerkih.
English: Dehydration may be a contributing factor in some of these cases.
Slovenian: K pojavu nekaterih od teh primerov bi lahko prispevala dehidracija.
English: Frequency groupings are defined to the following convention: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Slovenian: Razvrstitev pogostnosti je v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10) in pogosti (≥ 1/100 do < 1/10).
English: However, the magnitude of this effect could be larger for the 40 mg dose of telmisartan.
Slovenian: Vendar pa je lahko obseg tega učinka večji pri odmerku 40 mg telmisartana.
English: Your doctor or pharmacist will tell you the exact number of sachets and what strength to take at each time.
Slovenian: Zdravnik ali farmacevt vam bo natančno povedal, koliko vrečic in katero jakost morate vzeti ob določenem času.
English: Delayed or missed dose
Slovenian: Zamujen ali izpuščen odmerek
English: Do not stop taking Translarna without talking to your doctor.
Slovenian: Ne prenehajte jemati zdravila Translarna, ne da bi se posvetovali z zdravnikom.
English: Separation between ataluren and placebo was maintained from Week 16 through the end of the study.
Slovenian: Razlika med atalurenom in placebom se je ohranila od 16. tedna do konca študije.
English: - If you are allergic to ataluren or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na ataluren ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: As a precautionary measure, it is recommended to avoid the use of ataluren during pregnancy.
Slovenian: Kot previdnostni ukrep se priporoča izogibanje uporabi atalurena med nosečnostjo.
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: A risk to the breastfed new-borns/infants cannot be excluded.
Slovenian: Tveganja za dojene novorojenčke/dojenčke ni mogoče izključiti.
English: No effects on male and female fertility were observed, but effects of early juvenile treatment on fertility during adulthood were not investigated.
Slovenian: Učinkov na plodnost pri moških in ženskah niso opazili, vendar pa niso bili raziskani učinki zdravljenja v zgodnji mladosti na plodnost v odraslem obdobju.
English: Hypertension with use of concomitant systemic corticosteroids
Slovenian: Hipertenzija, povezana s sočasno uporabo sistemskih kortikosteroidov
English: The pharmacokinetics of ataluren has been evaluated in study PTC124-GD-030 over a duration of 4 weeks.
Slovenian: Farmakokinetiko atalurena so ovrednotili v študiji PTC124-GD-030, ki je trajala 4 tedne.
English: Higher ataluren exposure was associated with potential decrease in efficacy.
Slovenian: Večja izpostavljenost atalurenu je bila povezana s potencialnim zmanjšanjem učinkovitosti.
English: Description of selected adverse reactions (laboratory abnormalities)
Slovenian: Opis izbranih neželenih učinkov (laboratorijske nenormalnosti)
English: What you need to know before you take Translarna 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Translarna 3.
English: In a 48-week open-label extension study in patients with nmDMD patients who were ambulant or nonambulant demonstrated a similar safety profile.
Slovenian: V 48-tedenski odprti podaljšanji študiji pri bolnikih z nmDMD so bolniki, ki so bili pokretni ali nepokretni, kazali podoben varnostni profil.
English: 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.
Slovenian: Zaradi majhnega števila drugih ras, vključenih v klinične študije, ni mogoče podati nobenih zaključkov o vplivu UGT1A9 pri drugih etničnih skupinah.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Ireland
Slovenian: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD
English: The onset of reduction in relative bioavailability is estimated to occur approximately 60 hours after the first dose.
Slovenian: Relativna biološka uporabnost se po ocenah začne zmanjševati približno 60 ur po prvem odmerku.
English: Remember to take the next dose on time.
Slovenian: Ne pozabite vzeti naslednjega odmerka ob pravem času.
English: 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.
Slovenian: 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.
English: Patients who do not have a nonsense mutation
Slovenian: Bolniki brez nesmiselne mutacije
English: The safety and efficacy of Translarna in children <12kg and aged 6 months to 2 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Translarna pri otrocih < 12 kg in starih od 6 mesecev do 2 let, še nista bili dokazani.
English: It is important to take the correct dose.
Slovenian: Pomembno je, da se daje pravilen odmerek.
English: This means that there is more evidence to come about this medicine.
Slovenian: To pomeni, da se pričakujejo dodatni dokazi o zdravilu.
English: Weight Range (kg)
Slovenian: Razpon telesne mase (kg)
English: The majority of patients in all treatment groups were Caucasian (90%).
Slovenian: Večina bolnikov v vseh skupinah, ki so prejemale zdravljenje, je bila belcev (90 %).
English: Tell your doctor if you are taking any of the following medicines:
Slovenian: Obvestite zdravnika, če jemljete katero koli od naslednjih zdravil: Zdravilo
English: Open the sachet only at the time you are taking the medicine and use the entire amount from the sachet.
Slovenian: Odprite vrečico šele takrat, ko boste vzeli zdravilo, in uporabite celotno vsebino vrečice.
English: The majority of patients in both treatment groups were Caucasian (76%).
Slovenian: Večina bolnikov v obeh skupinah, ki sta prejemali zdravljenje, je bila belcev (76 %).
English: Increasing the dose above the recommended dose may be associated with reduced effectiveness.
Slovenian: Dajanje odmerkov, večjih od priporočenih, je lahko povezano z manjšo učinkovitostjo.
English: Translarna is available in packs containing 30 sachets.
Slovenian: Zdravilo Translarna je na voljo v pakiranjih, ki vsebujejo 30 vrečic.
English: Do not use this medicine after the expiry date, which is stated on the carton and sachet after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečici poleg oznake "EXP".
English: In a 26-week transgenic mouse model for carcinogenicity, no evidence of carcinogenicity was found.
Slovenian: Pri transgenem mišjem modelu za proučevanje rakotvornosti po 26 tednih niso odkrili nobenih znakov rakotvornosti.
English: Females were not studied in nmDMD clinical trials.
Slovenian: Žensk v kliničnih preskušanjih pri bolnikih z nmDMD niso proučevali.
English: Time to 10% worsening in 6MWD was defined as the last time that 6MWD was not 10% worse than baseline.
Slovenian: Čas do 10-% poslabšanja v 6MWD je opredeljen kot zadnja časovna tička, ko 6MWD ni bila za 10 % slabša kot ob izhodišču.
English: Other medicines and Translarna
Slovenian: Druga zdravila in zdravilo Translarna
English: Pharmacotherapeutic group:Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX03
Slovenian: Farmakoterapevtska skupina: druga zdravila za zdravljenje bolezni mišično-skeletnega sistema, oznaka ATC: M09AX03
English: Co. Armagh BT63 5UA
Slovenian: Co. Armagh BT63 5UA Velika Britanija
English: 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.
Slovenian: 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.
English: Morning
Slovenian: Zjutraj
English: In vitro, ataluren is 99.6% bound to human plasma proteins and the binding is independent of plasma concentration.
Slovenian: In vitro se 99,6 % atalurena veže na človeške plazemske beljakovine, pri čemer vezava ni odvisna od plazemske koncentracije.
English: Translarna is used to treat patients aged 2 years and older, who are able to walk.
Slovenian: Zdravilo Translarna se uporablja za zdravljenje bolnikov, starih 2 let ali več, ki lahko hodijo.
English: Presence of radioactivity in pup plasma confirmed absorption from the milk by the pups.
Slovenian: Prisotnost radioaktivnosti v plazmi mladičev je potrdila absorpcijo iz mleka.
English: These results indicate that ataluren 40 mg/kg/day slows the loss of walking ability in nmDMD patients.
Slovenian: Ti rezultati kažejo, da ataluren 40 mg/kg/dan upočasni izgubo zmožnosti hoje pri bolnikih z nmDMD.
English: 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.
Slovenian: 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.
English: Take Translarna by mouth 3 times per day; in the morning, midday and evening.
Slovenian: Zdravilo Translarna jemljite skozi usta 3-krat na dan, in sicer zjutraj, zgodaj popoldne in zvečer.
English: If you have any kidney problem, your doctor should check your kidney function regularly.
Slovenian: Če imate kakršne koli težave z ledvicami, mora zdravnik redno preverjati delovanje vaših ledvic.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Patients who experience dizziness should use caution when driving, cycling or using machines.
Slovenian: Bolniki, pri katerih se pojavlja omotica, morajo biti pri vožnji, kolesarjenju ali upravljanju strojev previdni.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: adefovir treatment of chronic hepatitis B and/or HIV
Slovenian: Običajno se predpiše za aciklovir zdravljenje noric adefovir zdravljenje kroničnega hepatitisa B in/ali virusa HIV
English: But, take the next doses on time.
Slovenian: Naslednje odmerke vzemite ob pravem času.
English: 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
Slovenian: 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
English: A standard package of reproduction toxicity studies was available.
Slovenian: Na voljo so bile standardne študije o vplivu na sposobnost razmnoževanja.
English: No serious adverse reactions were observed in these subjects.
Slovenian: Resnih neželenih učinkov pri teh osebah niso opazili.
English: Study 2 evaluated 230 male patients, ages 7 to 14 years.
Slovenian: V študiji 2 so ocenili 230 moških bolnikov, starih od 7 do 14 let.
English: Percent Not 10% Worsened
Slovenian: Odstotek brez 10-odstotnega poslabšanja
English: TRANSLARNA 10 mg/kg, 10 mg/kg, 20 mg/kg (N=57) Placebo (N=57)
Slovenian: TRANSLARNA 10, 10, 20 mg/kg (n = 57) placebo (n = 57)
English: What Translarna is and what it is used for
Slovenian: Kaj je zdravilo Translarna in za kaj ga uporabljamo
English: A lower ataluren dose should be considered.
Slovenian: Razmisliti je treba o nižjem odmerku atalurena.
English: Magnesium stearate
Slovenian: magnezijev stearat
English: Your dose of Translarna depends on your body weight.
Slovenian: Odmerek zdravila Translarna, ki ga boste jemali, bo odvisen od vaše telesne mase.
English: 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.
Slovenian: 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
English: Kaplan-Meier Curve of Time to Persistent 10% 6MWD Worsening (Study 1)
Slovenian: Kaplan-Meierjeva krivulja časa do persistentnega 10-odstotnega poslabšanja 6MWD
English: It is unknown whether ataluren/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se ataluren/presnovki izločajo v materino mleko.
English: Based on data in healthy volunteers, the relative bioavailability of ataluren is approximately 40% lower at steady-state than after the initial dose.
Slovenian: Glede na podatke, pridobljene pri zdravih prostovoljcih, je relativna biološka uporabnost atalurena v stanju dinamičnega ravnovesja za približno 40 % manjša kot po začetnem odmerku.
English: In addition, at exposure much higher than in patients an increase of (rare) urinary bladder tumours was found.
Slovenian: Poleg tega so pri izpostavljenosti, ki je bila veliko večja kot pri bolnikih, odkrili povečano število (redkih) tumorjev sečnega mehurja.
English: In addition, one case of malignant hibernoma was found at the highest dose in a 2-year rat carcinogenicity study.
Slovenian: Poleg tega so en primer malignega hibernoma odkrili tudi pri največjem odmerku v 2-letni študiji rakotvornosti pri podganah.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Study 1 evaluated 174 male patients, ages 5 to 20 years.
Slovenian: V študiji 1 so ocenili 174 moških bolnikov, starih od 5 do 20 let.
English: The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged >5years.
Slovenian: Učinkovitost zdravila Translarna pri otrocih, starih od 2 do 5 let, je bila dokazana z ekstrapolacijo z bolnikov, starih > 5 let.
English: 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.
Slovenian: 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
English: The toxicity of the metabolite is unknown.
Slovenian: Toksičnost presnovka ni znana.
English: The primary efficacy endpoint in both trials was change in 6 Minute Walk Distance (6MWD) at Week 48.
Slovenian: Primarni opazovani dogodek učinkovitosti v obeh preskušanjih je bila sprememba v razdalji, prehojeni v 6 minutah (6MWD, 6 Minute Walk Distance) v 48. tednu.
English: Very common side effects (may affect more than 1 in 10 people): - Vomiting
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - bruhanje.
English: Although ataluren is practically insoluble in water, ataluren is readily absorbed after oral administration as a suspension.
Slovenian: Čeprav je ataluren skoraj netopen v vodi, se po peroralnem dajanju v obliki suspenzije zlahka absorbira.
English: Efficacy has not been demonstrated in non-ambulatory patients.
Slovenian: Učinkovitost pri imobilnih bolnikih ni bila dokazana.
English: In a statistical based model the estimated mean difference was 13.0 meters (p=0.213), Figure 4.
Slovenian: V statističnem modelu je bila ocenjena povprečna razlika 13,0 metra (p = 0,213), slika 4.
English: Treatment with Translarna should only be initiated by specialist physicians with experience in the management of Duchenne/Becker muscular dystrophy.
Slovenian: Zdravljenje z zdravilom Translarna sme uvesti samo zdravnik specialist, ki ima izkušnje z zdravljenjem Duchennove/Beckerjeve mišične distrofije.
English: These data indicate no apparent drug-drug interaction between corticosteroids and ataluren, and no dose adjustments are required.
Slovenian: Ti podatki kažejo, da ne prihaja do opaznega medsebojnega delovanja kortikosteroidov in atalurena, zato prilagajanje odmerkov ni potrebno.
English: In a 2-year rat carcinogenicity study, one case of hibernoma was found.
Slovenian: V 2-letni študiji rakotvornosti pri podganah so odkrili en primer hibernoma.
English: Take each prepared dose immediately after preparation.
Slovenian: Posamezen pripravljen odmerek vzemite takoj po pripravi.
English: The safety and efficacy of ataluren in patients aged 65 and older have not yet been established (see section 5.2).
Slovenian: Starejši Varnost in učinkovitost atalurena pri bolnikih, starih 65 let ali več, še nista bili dokazani (glejte poglavje 5.2).