FrancophonIA/ELRC3.0 huggingface dataset:
English: Crysvita is given as an injection under the skin.
Slovenian: Zdravilo Crysvita se daje z injiciranjem pod kožo.
English: Why is Crysvita approved?
Slovenian: Zakaj je bilo zdravilo Crysvita odobreno?
English: Since Crysvita has been granted a conditional approval, the company that markets Crysvita will provide updated results from two ongoing studies in children aged between 5 and 12 years and between 1 and 4 years.
Slovenian: Ker je zdravilo Crysvita pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila posodobljene rezultate dveh študij, ki še potekata, pri otrocih, starih od 5 do 12 let in od 1 do 4 let.
English: Phosphate levels are largely controlled by the kidneys, which either remove excess phosphate or reabsorb it into the bloodstream when needed.
Slovenian: Ravni fosfatov uravnavajo predvsem ledvice, ki bodisi odstranjujejo čezmerne fosfate bodisi jih reabsorbirajo v kri, kadar je to potrebno.
English: For practical information about using Crysvita, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Crysvita naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is not intended to provide practical advice on how to use Crysvita.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: An additional ongoing study in 13 younger children shows that Crysvita is effective in those aged between 1 and 4 years.
Slovenian: Dodatna študija, ki prav tako še poteka, pri 13 mlajših otrocih je pokazala, da je zdravilo Crysvita učinkovito pri otrocih, starih od 1 do 4 let.
English: Because the number of patients with X-linked hypophosphataemia is low, the disease is considered ‘rare', and Crysvita was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 October 2014.
Slovenian: Ker je bolnikov z na kromosom X vezano hipofosfatemijo malo, velja ta bolezen za redko, zato je bilo zdravilo Crysvita 15. oktobra 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Crysvita is a monoclonal antibody (a type of protein) designed to recognise and attach to the FGF23 protein.
Slovenian: Zdravilo Crysvita je monoklonsko protitelo (vrsta beljakovine), zasnovano za prepoznavo beljakovine FGF23 in vezavo nanjo.
English: For the full list of restrictions with Crysvita see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Crysvita glejte navodilo za uporabo.
English: The dose is adjusted according to the patient's phosphate levels in the blood.
Slovenian: Odmerek je treba prilagoditi bolnikovim ravnem fosfatov.
English: What information is still awaited for Crysvita?
Slovenian: Katere informacije o zdravilu Crysvita še pričakujemo?
English: By attaching to the FGF23 protein, the medicine blocks its activity, allowing the kidneys to reabsorb phosphate and restore normal levels of phosphate in the blood.
Slovenian: Zdravilo z vezavo na beljakovino FGF23 zavira njeno delovanje, s čimer ledvicam omogoča reabsorpcijo fosfatov in obnovo normalnih ravni fosfatov v krvi.
English: The company is also required to conduct and submit the results of a study comparing Crysvita with oral phosphate and vitamin D in children aged between 1 and 12 years with X-linked hypophosphataemia.
Slovenian: Družba mora tudi izvesti študijo, v kateri bodo zdravilo Crysvita primerjali s peroralnimi fosfati in vitaminom D pri otrocih, starih od 1 do 12 let, z na kromosom X vezano hipofosfatemijo, ter predložiti njene rezultate.
English: Patients with X-linked hypophosphataemia have abnormally high levels of a protein called FGF23 which causes the kidneys to stop reabsorbing phosphate into the bloodstream.
Slovenian: Bolniki z na kromosom X vezano hipofosfatemijo imajo nenormalno visoke ravni beljakovine FGF23, ki povzroča, da ledvice prenehajo reabsorbirati fosfate v krvni obtok.
English: Crysvita is a medicine used for the treatment of X-linked hypophosphataemia, a hereditary disorder characterised by low levels of phosphate in the blood (hypophosphataemia).
Slovenian: Crysvita je zdravilo, ki se uporablja za zdravljenje na kromosom X vezane hipofosfatemije, dedne motnje, za katero so značilne nizke ravni fosfatov v krvi (hipofosfatemija).
English: Crysvita reduced the severity of rickets as shown in X-rays in children with X-linked hypophosphataemia.
Slovenian: Zdravilo Crysvita je zmanjšalo resnost rahitisa, razvidno z rentgenskih posnetkov otrok z na kromosom X vezano hipofosfatemijo.
English: How is Crysvita used?
Slovenian: Kako se zdravilo Crysvita uporablja?
English: Crysvita was shown to reduce the severity of bone deformities in the wrist and knee and improve the level of phosphate in the blood of children with X-linked hypophosphataemia in one ongoing study, and further data are awaited.
Slovenian: V eni študiji, ki še poteka, se je izkazalo, da zdravilo Crysvita zmanjšuje resnost kostnih deformacij zapestja in kolena ter povečuje raven fosfatov v krvi otrok z na kromosom X vezano hipofosfatemijo, pričakujejo pa se še nadaljnji podatki.
English: Crysvita contains the active substance burosumab.
Slovenian: Zdravilo Crysvita vsebuje zdravilno učinkovino burosumab.
English: How does Crysvita work?
Slovenian: Kako zdravilo Crysvita deluje?
English: Also, Crysvita must not be used in patients with high phosphate levels in the blood or in patients with severe kidney disease.
Slovenian: Med zdravljenjem z zdravilom Crysvita se ne smejo uporabljati peroralna zdravila, ki vsebujejo fosfate ali vitamin D. Zdravilo Crysvita se poleg tega ne sme uporabljati pri bolnikih z visoko ravnijo fosfatov v krvi ali pri bolnikih s hudo boleznijo ledvic.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Slovenian: Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic bodo zagotovili, kadar je to primerno, da imetnik(i) dovoljenja za promet z zdravilom izpolni(jo) naslednje pogoje:
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo ugotoviti specifično populacijo bolnikov, pri kateri so koristi zdravila večje od ugotovljenega tveganja.
English: Conditions for lifting the suspension of the marketing authorisation
Slovenian: Pogoji za preklic začasnega umika dovoljenja za promet z zdravilom
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Slovenian: Priloga IV Pogoji za preklic začasnega umika dovoljenja za promet z zdravilom
English: Initiation pack: 28 tablets (7 x 90 mg + 21 x 180 mg)
Slovenian: 90 mg + 180 mg začetno pakiranje: 28 tablete (7 x 90 mg + 21 x 90 mg)
English: Your doctor will assess you carefully.
Slovenian: Vaš zdravnik vas bo natančno ocenil.
English: This pack is intended to be used for the first 10 days of treatment.
Slovenian: To pakiranje je namenjeno za uporabo v prvih 10 dneh zdravljenja.
English: Start of treatment (first 4 weeks):
Slovenian: Začetek zdravljenja (prvi 4 tedni):
English: Interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja so izvedli samo pri odraslih.
English: Only safety data were collected in this study; no new safety signals were identified.
Slovenian: V tej študiji so bili zbrani le podatki o varnosti; novih učinkov, povezanih z varnostjo, niso ugotovili.
English: After 4 weeks:
Slovenian: Po 4 tednih:
English: Your doctor will discuss with you the risks and benefits of using this medicine in these situations.
Slovenian: Zdravnik se bo pogovoril z vami o tveganjih in koristih uporabe tega zdravila v takih situacijah.
English: If this happens to you, do not drive or use machines.
Slovenian: Če se vam to zgodi, ne smete voziti in upravljati s stroji.
English: The capsules can be taken either with or without food.
Slovenian: Kapsule se lahko jemljejo s hrano ali brez nje.
English: • abnormally frequent daytime urination
Slovenian: • nenormalno pogosto dnevno uriniranje
English: However, some side effects may be serious and require treatment.
Slovenian: Nekateri neželeni učinki pa so lahko resni in zahtevajo zdravljenje.
English: (syncope), fall
Slovenian: (sinkopa), padci
English: • sexual dysfunction
Slovenian: • spolna disfunkcija
English: Children and adolescents NUEDEXTA should not be used in children and adolescents below the age of 18 years.
Slovenian: Otroci in mladostniki Zdravilo NUEDEXTA se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Subjects were 25 to 80 years of age with a mean age of approximately 51 years.
Slovenian: Preskušanci so bili stari od 25 do 80 let, s povprečno starostjo približno 51 let.
English: This medicine may cause changes in heart rhythm.
Slovenian: To zdravilo lahko povzroči spremembe srčnega ritma.
English: • you have a tendency to have falls.
Slovenian: • ste nagnjeni k padcem.
English: Do not stop taking this medicine without speaking to your doctor first, even if you begin to feel better.
Slovenian: Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom, tudi če se počutite bolje.
English: Furthermore, educational material for HCPs should provide information on the following safety concerns and on the actions needed to reduce the risks:
Slovenian: Poleg tega bo izobraževalni material zdravstvenim delavcem zagotovil informacije o naslednjih varnostnih zadržkih in o ukrepih, ki so potrebni za zmanjševanje tveganj:
English: • Pivotal study (07-AVR-123)
Slovenian: • Ključna študija (07-AVR-123)
English: Clinical studies did not include a sufficient number of patients aged ≥65 years to conclusively determine whether they respond differently in terms of efficacy and safety.
Slovenian: Klinične študije niso vključile zadostnega števila bolnikov, starih ≥ 65 let, da bi lahko zagotovo potrdili, ali se odzivajo drugače glede na učinkovitost in varnost.
English: • Allergic reactions
Slovenian: • alergijskih reakcijah;
English: • Weeks 2-4 (day 8-28):
Slovenian: • 2.-4. teden (8.-28. dan):
English: Regardless of which strength of NUEDEXTA has been prescribed to you: • continue the treatment with: two capsules per day (one capsule every 12 hours).
Slovenian: Ne glede na to, katera jakost zdravila NUEDEXTA vam je bila predpisana: • nadaljujte zdravljenje z: dvema kapsulama na dan (ena kapsula na vsakih 12 ur).
English: Depending on your response to the treatment, your doctor may either decide:
Slovenian: Glede na vaš odziv na zdravljenje, se bo zdravnik odločil:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Slovenian: Pred uvedbo na trg v vsaki državi članici se bo imetnik dovoljenja za promet s pristojnim nacionalnim organom dogovoril o izobraževalnem programu.
English: This medicine may cause dizziness and your doctor might need to discuss appropriate precautions to reduce the risk of falls.
Slovenian: To zdravilo lahko povzroči omotico, zato se bo vaš zdravnik morda želel pogovoriti o primernih previdnostnih ukrepih za zmanjšanje tveganja za padce;
English: A review of the patient's current medicines is an essential part of the evaluation of patients for whom treatment with NUEDEXTA is proposed.
Slovenian: Pregled trenutnih bolnikovih zdravil je ključen del ocene bolnikov, za katere se predlaga zdravljenje z zdravilom NUEDEXTA.
English: Dose increase, if warranted, should be undertaken with caution in these patients.
Slovenian: Povečanje odmerka, kjer je upravičeno, je treba pri teh bolnikih uvesti previdno.
English: Approximately 74% were Caucasian, 4% were Black, 1% were Asian and 19% were of Hispanic origin.
Slovenian: Približno 74 % preskušancev je bilo kavkazijskega porekla, 4 % temnopoltih, 1 % jih je bil azijskega in 19 % hispanskega porekla.
English: Description:
Slovenian: Opis:
English: The capsules should be taken orally at about the same time each day.
Slovenian: Kapsule se smejo uporabljati samo peroralno, ob približno istem času vsak dan.
English: Adverse reactions observed with this medicine may occur more often or may worsen and your doctor may perform some test and monitor you more closely.
Slovenian: Neželene reakcije, ki so jih opazili pri uporabi tega zdravila, se lahko pojavijo pogosteje ali se poslabšajo, zato bo vaš zdravnik morda opravil teste in vas podrobneje spremljal.
English: Treatment of hypotension and of other signs and symptoms should be directed at symptomatic and supportive measures.
Slovenian: Zdravljenje hipotenzije in drugih znakov ter simptomov mora biti usmerjeno na simptomatske in podporne ukrepe.
English: Squeeze and hold at tabs above and below () Pull out card to the right ( )
Slovenian: Za odvijanje kapsul iz embalaže: stisnite in držite na jezičkih zgoraj in spodaj (); izvlecite kartico na desno stran ( ).
English: NMDA receptor antagonists (memantine)
Slovenian: Antagonisti receptorjev NMDA (memantin)
English: • Studies to Assess Cardiac Effects
Slovenian: • Študije za oceno učinkov na srce
English: • you have problems with your liver or kidney.
Slovenian: • imate težave z jetri ali ledvicami.
English: • you have had at any time a serious condition called “serotonin syndrome”, which can be caused by certain medicines e.g. antidepressants.
Slovenian: • ste kadar koli imeli resno bolezen, imenovano “serotoninski sindrom”, ki ga lahko povzročijo določena zdravila, npr. antidepresivi.
English: The patient alert card should be provided to all patients with instructions to carry it on them at all times.
Slovenian: Kartica z opozorili za bolnika mora biti dana vsem bolnikom z navodilom, naj jo imajo ves čas pri sebi.
English: These may be a sign of a serious condition called “serotonin syndrome”.
Slovenian: To so lahko znaki resne bolezni, imenovane “serotoninski sindrom”.
English: • 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: • 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 sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: The dose of paroxetine can then be adjusted based on clinical response; however, dosage above 35 mg/day is not recommended.
Slovenian: Potem se lahko odmerek paroksetina prilagodi na podlagi kliničnega odziva, vendar odmerek, večji od 35 mg/dan, ni priporočljiv.
English: However, cases of dextromethorphan abuse have been reported, predominately in adolescents.
Slovenian: Vendar so poročali o primerih zlorabe dekstrometorfana, predvsem pri mladostnikih.
English: In the event of inadequate clinical response, see recommended dose titration schedule.
Slovenian: Če je klinični odziv nezadosten, glejte priporočeni razpored titracije odmerka.
English: The clinical relevance of this observation to drugs that are OCT1 substrates, such as metformin, is unknown.
Slovenian: Klinični pomen te ugotovitve za zdravila, ki so substrati OCT1, npr. za metformin, ni znan.
English: Other antiarrhythmics with Class I (procainamide) or Class III activities should (if possible) be avoided.
Slovenian: Prav tako se je treba izogibati drugim antiaritmikom z dejavnostjo razreda I (prokainamid) ali razreda III (če je to mogoče).
English: • The active substances are:
Slovenian: • Zdravilni učinkovini sta:
English: It is very important to tell your doctor if you are taking any of the medicines listed below, as these medicines should never be taken while you are taking NUEDEXTA:
Slovenian: Zelo pomembno je, da svojega zdravnika obvestite, če jemljete katero koli od spodaj naštetih zdravil,saj se teh zdravil ne sme jemati, ko jemljete zdravilo NUEDEXTA:
English: • you or a family member currently have or have ever had any heart disease or problems.
Slovenian: • imate vi ali vaš družinski član oz. če ste imeli vi ali vaš družinski član kakršno koli srčno bolezen ali težave s srcem.
English: In addition it shows affinity for the serotonin transporter (SERT) and for the 5-HT1B/D receptor.
Slovenian: Poleg tega je pokazal afiniteto za prenašalec serotonina (SERT) in receptor 5-HT1B/D.
English: In case a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time.
Slovenian: Če bolnik pozabi vzeti odmerek, ne sme vzeti dodatnega odmerka, ampak mora vzeti naslednji predpisani odmerek ob običajnem času.
English: Stopping treatment may cause your symptoms to return.
Slovenian: Prenehanje zdravljenja lahko povzroči ponoven nastop vaših simptomov.
English: Methods as to acidify the urine and dialysis are of no demonstrated benefit.
Slovenian: Metode z zakisanjem urina in dializo niso pokazale nobene koristi.
English: No pharmacodynamic interactions were apparent.
Slovenian: Opazili niso nobenih očitnih farmakodinamičnih interakcij.
English: If you have certain heart problems or are currently taking certain other medicines, NUEDEXTA may not be appropriate for you, or your doctor may want to monitor your heart activity when you start NUEDEXTA.
Slovenian: Če imate določene težave s srcem ali če trenutno jemljete določena druga zdravila, zdravilo NUEDEXTA morda ne bo primerno za vas ali pa bo vaš zdravnik morda želel spremljati delovanje vašega srca, ko boste začeli uporabljati zdravilo NUEDEXTA;
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, or if you are not using reliable contraception, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev oziroma če ne uporabljate zanesljive metode kontracepcije, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: A list of all other side effects is provided below:
Slovenian: Seznam vseh ostalih neželenih učinkov se nahaja spodaj:
English: Your doctor will decide if you should take this medicine while breast-feeding.
Slovenian: Vaš zdravnik se bo odločil, ali lahko uporabljate to zdravilo med dojenjem.
English: NUEDEXTA is a combination of two active substances:
Slovenian: Zdravilo NUEDEXTA je kombinacija dveh zdravilnih učinkovin:
English: Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicine or NUEDEXTA.
Slovenian: Zdravnik vas bo natančno spremljal glede neželenih učinkov in/ali bo morda moral prilagoditi odmerek drugega zdravila ali zdravila NUEDEXTA.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: • For the first seven days of treatment: one capsule per day, taken in the morning.
Slovenian: • v prvih sedmih dneh zdravljenja: eno kapsulo na dan, ki jo vzamete zjutraj;
English: • if you have a heart problem called “complete heart block” or “long QT syndrome” or have had a problem with your heart called “torsades de pointes”.
Slovenian: • če imate težave s srcem, imenovane „popolni srčni blok“ ali „sindrom dolgega intervala QT“ ali pa ste imeli težave s srcem, imenovane „torsades de pointes“;
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where Nuedexta is marketed, at launch and after launch, all healthcare professionals who are expected to prescribe Nuedexta are provided with the following items:
Slovenian: Imetnik dovoljenja za promet bo zagotovil, da bodo po razpravi in v soglasju z nacionalnimi pristojnimi organi v vsaki državi članici, kjer se bo zdravilo Nuedexta tržilo, ob uvedbi na trg in po uvedbi na trg vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Nuedexta, prejeli naslednje:
English: Pharmacotherapeutic group: Other nervous system drugs; ATC code: N07XX59
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje; oznaka ATC: N07XX59
English: Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
Slovenian: Uvesti je treba previdnostne ukrepe za zmanjšanje tveganja za padce, predvsem pri bolnikih z motorično okvaro, ki vpliva na hojo, ali padce v anamnezi.
English: Depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you and monitor you more closely for potential side effects.
Slovenian: Glede na resnost vaših težav bo vaš zdravnik natančno razmislil, ali je to zdravilo primerno za vas, in vas natančneje spremljal glede morebitnih neželenih učinkov;
English: Non-clinical data reveal no special hazard for a genotoxicity or carcinogenic potential, nor for fertility impairment.
Slovenian: Predklinični podatki ne kažejo posebnega tveganja za genotoksični ali karcinogeni potencial ali za zmanjšano plodnost.
English: • tamoxifen, used to treat or prevent some cancers
Slovenian: • tamoksifen, ki ga uporabljamo za zdravljenje in preprečevanje nekaterih vrst raka;
English: • Week 1 (day 1-7):
Slovenian: • 1. teden (1.-7. dan):
English: In the pre and post-natal developmental study, slight developmental delay was seen in offspring at the mid- and high-doses.
Slovenian: V študiji prenatalnega in postnatalnega razvoja so opazili manjši razvojni zaostanek mladičev pri srednjih in visokih odmerkih.
English: Do not take NUEDEXTA if you have taken these antidepressants during the last two weeks and allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
Slovenian: Ne vzemite zdravila NUEDEXTA, če ste v zadnjih dveh tednih jemali te antidepresive, in počakajte vsaj 14 dni po prenehanju jemanja zdravila NUEDEXTA, preden začnete z jemanjem MAOI.
English: • you have a history of drug abuse.
Slovenian: • v vaši anamnezi obstaja zloraba drog.
English: The most important effects of acute overdoses are ventricular arrhythmias and hypotension.
Slovenian: Najpomembnejši učinki akutnega prevelikega odmerjanja so ventrikularne aritmije in hipotenzija.
English: • if you are allergic to dextromethorphan, quinidine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na dekstrometorfan, kinidin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: NUEDEXTA has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo NUEDEXTA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Each blister is packed in a sleeve.
Slovenian: Vsaka plastenka je pakirana v škatlo.
English: Due to the possibility of dextromethorphan abuse, physicians should evaluate patients for a history of drug abuse, and observe such patients closely for signs of misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behaviour).
Slovenian: Zaradi možnosti zlorabe dekstrometorfana morajo zdravniki pri bolnikih oceniti, ali obstaja zloraba drog v anamnezi, in take bolnike pozorno spremljati za znake napačne uporabe ali zlorabe (npr. razvoj tolerance, povečanje odmerka, vedenje, ki kaže na zasvojenost).