FrancophonIA/ELRC3.0 huggingface dataset:
English: SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise
Slovenian: SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise 30 mg/ml
English: Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Slovenian: 58, rue du Pont de Créteil
English: EMA/430531/2016 Rev 1 EMEA/H/C/003846
Slovenian: EMA/430531/2016 EMEA/H/C/003846
English: It was to be available as a solution for injection under the skin.
Slovenian: Na voljo naj bi bila v obliki raztopine za injiciranje pod kožo.
English: The company stated that it intended to stop the development of the medicine, but that it plans to work with doctors, patients and local regulatory authorities to allow currently treated patients to access the remaining supply of Kyndrisa.
Slovenian: Družba je navedla, da namerava ustaviti razvoj zdravila, vendar načrtuje sodelovanje z zdravniki, bolniki in lokalnimi regulativnimi organi in želi omogočiti trenutno zdravljenim bolnikom dostop do preostalih zalog zdravila Kyndrisa.
English: It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood.
Slovenian: Povzroča napredujočo oslabelost in zmanjševanje mišične funkcije ter navadno povzroča smrt v adolescenci ali zgodnji odrasli dobi.
English: Kyndrisa is a medicine that contains the active substance drisapersen.
Slovenian: Kyndrisa je zdravilo, ki vsebuje zdravilno učinkovino drisapersen.
English: The Committee considered that data from the clinical studies did not sufficiently demonstrate a beneficial effect of Kyndrisa: the main study did not show any benefit in patients with the condition, while two other studies failed to consistently show a beneficial effect.
Slovenian: Odbor je ocenil, da podatki iz kliničnih študij koristnega učinka zdravila Kyndrisa ne dokazujejo v zadostni meri: z glavno študijo niso dokazali koristi pri bolnikih s to boleznijo, drugi dve študiji pa koristnega učinka nista dosledno dokazali.
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen) EMA/430531/2016
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Kyndrisa (drisapersen) EMA/430531/2016
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Kyndrisa (drisapersen)
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues.
Slovenian: Potem ko je ocenil odgovore družbe na zadnji sklop vprašanj, so nekatera pomembna vprašanja še vedno ostala nerešena.
English: Further, the safety profile of the medicine was not considered satisfactory, particularly because of the risk of persisting reactions at the injection site (such as swelling, inflammation and ulceration) which could have a negative impact on quality of life, and the risk of thrombocytopenia (low blood platelet counts) which could put patients at risk of serious bleeding complications.
Slovenian: Poleg tega tudi varnostni profil zdravila ni bil ocenjen kot zadovoljiv, zlasti zaradi tveganja za trajne reakcije na mestu injiciranja (kot so otekanje, vnetje in razjede), ki bi lahko negativno vplivale na kakovost življenja, in tveganja za trombocitopenijo (nizko raven trombocitov), ki bi lahko povečalo tveganje za hude zaplete s krvavitvami.
English: Kyndrisa was investigated in three studies in a total of 290 patients with Duchenne muscular dystrophy.
Slovenian: Zdravilo Kyndrisa so preučevali v treh študijah pri skupaj 290 bolnikih z Duchennovo mišično distrofijo.
English: Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6.
Slovenian: Duchennova mišična distrofija je huda genetska bolezen, ki večinoma prizadene dečke in se navadno diagnosticira pred 6. letom starosti.
English: The studies compared the effects of Kyndrisa with placebo (a dummy treatment) and the main measure of effectiveness was the change in the distance the patient could walk in six minutes after 24 or 48 weeks of treatment.
Slovenian: V študijah so primerjali učinek zdravila Kyndrisa s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bila sprememba razdalje, ki jo je bolnik lahko prehodil v šestih minutah po 24 ali 48 tednih zdravljenja.
English: Kyndrisa was expected to be used for the treatment of Duchenne muscular dystrophy in patients aged 5 years and older who are able to walk and whose disease is due to certain genetic mutations (defects) that can be treated with ‘exon 51 skipping technology'.
Slovenian: Zdravilo Kyndrisa naj bi se uporabljalo za zdravljenje Duchennove mišične distrofije pri bolnikih, starih pet let in več, ki lahko hodijo, njihova bolezen pa je posledica določenih genetskih mutacij (okvar) in se lahko zdravi s „tehnologijo preskakovanja eksona 51“.
English: On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy.
Slovenian: Družba BioMarin International Limited je dne 31. maja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Kyndrisa, namenjenim zdravljenju Duchennove mišične distrofije.
English: This technology enables the protein-making apparatus in cells to skip some areas of the dystrophin gene and allow the production of a shortened but partially working dystrophin protein.
Slovenian: S to tehnologijo aparat za proizvodnjo beljakovin v celicah preskoči nekatera območja gena za distrofin in omogoči tvorbo krajše, vendar še delno delujoče distrofinske beljakovine.
English: What is Kyndrisa?
Slovenian: Kaj je zdravilo Kyndrisa?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Kyndrisa could not have been approved for the treatment of Duchenne muscular dystrophy.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil odbor CHMP, je ta v času umika izrazil določene zadržke in je začasno menil, da zdravila Kyndrisa ni mogoče odobriti za zdravljenje Duchennove mišične distrofije.
English: Duchenne muscular dystrophy is caused by mutations in the gene for the protein dystrophin, which lead to the production of a non-functional dystrophin.
Slovenian: Duchennovo mišično distrofijo povzročajo mutacije v genu za beljakovino distrofin, kar povzroči nastajanje nedelujočega distrofina.
English: What was Kyndrisa expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Kyndrisa uporabljalo?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Kyndrisa did not outweigh its risks.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Kyndrisa ne odtehtajo z njim povezanih tveganj.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it would not be able to address the CHMP concerns regarding the results of the clinical studies within the expected timeframe.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da v pričakovanem časovnem okviru ne bi mogla ukrepati v zvezi z zadržki odbora CHMP o rezultatih kliničnih študij.
English: This medicine works by ‘exon 51 skipping
Slovenian: To zdravilo deluje s pomočjo „tehnologije preskakovanja eksona 51“.
English: Kyndrisa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 February 2009 for Duchenne muscular dystrophy.
Slovenian: Zdravilo Kyndrisa je bilo dne 27. februarja 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za Duchennovo mišično distrofijo.
English: How is Kyndrisa expected to work?
Slovenian: Kako naj bi zdravilo Kyndrisa delovalo?
English: OPEN HERE LIFT HERE
Slovenian: ODPRITE TUKAJ DVIGNITE TUKAJ
English: 22014 Incheon Republic of Korea
Slovenian: 22014 Incheon Republika Koreja
English: Date of first authorisation: 28 March 2019
Slovenian: Datum prve odobritve: 28. marec 2019
English: Important information:
Slovenian: Pomembne informacije:
English: Long-term study (Study 3)
Slovenian: Dolgoročna študija (študija 3)
English: More than 1,400 patients were treated for at least 12 months.
Slovenian: Več kot 1.400 bolnikov so zdravili najmanj 12 mesecev.
English: Two dosing options are available:
Slovenian: Na voljo sta dve možnosti odmerjanja:
English: d) Wash your hands with soap and water and dry well with a clean towel.
Slovenian: d) Umijte si roke z milom in vodo ter jih dobro osušite s čisto brisačo.
English: The treatment benefit should be assessed within 3 months after initiation of treatment.
Slovenian: Koristi zdravljenja je treba oceniti v 3 mesecih po uvedbi zdravljenja.
English: c) Remove the needle from your skin.
Slovenian: c) Odstranite iglo iz kože.
English: Any further decision to continue treatment should be taken on an individual patient basis.
Slovenian: Vsaka nadaljnja odločitev o nadaljevanju zdravljenja naj temelji na individualni oceni bolnika.
English: Your doctor will discuss and decide with you the most appropriate dosing schedule.
Slovenian: Zdravnik se bo pogovoril z vami in izbral najprimernejši režim odmerjanja.
English: Do not remove pressure until the 3 steps below are complete.
Slovenian: Pritiska ne popustite, dokler ne opravite naslednjih 3 korakov.
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period.
Slovenian: Znano je, da se humani IgG izloča v materino mleko v prvih dneh po rojstvu, nato pa se kmalu zmanjša na manjše koncentracije; posledično tveganja za dojenega otroka v tem kratkem času ne moremo izključiti.
English: ATC code: Not yet assigned.
Slovenian: Oznaka ATC: še ni bila dodeljena.
English: You wait another 10 seconds (to make sure all of the medicine is injected).
Slovenian: Počakajte še 10 sekund (da se prepričate, da ste injicirali vse zdravilo).
English: This reduction in CGRP's activity reduces migraine attacks.
Slovenian: To zmanjšanje aktivnosti CGRP zmanjša napade migrene.
English: No safety data are available in these patients.
Slovenian: Podatki o varnosti za te bolnike niso na voljo.
English: Your doctor or nurse will explain to you or your caregiver how to give the injection.
Slovenian: Zdravnik ali medicinska sestra bo vam ali vašemu negovalcu pojasnila, kako se injekcija daje.
English: All injection site reactions resolved, mostly within a few hours or days.
Slovenian: Vse reakcije na mestu injiciranja so izzvenele, večinoma v nekaj urah ali dneh.
English: Intrinsic and extrinsic factors
Slovenian: Intrinzični in ekstrinzični dejavniki
English: The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila AJOVY pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: How much and when to inject
Slovenian: Koliko zdravila je treba injicirati in kdaj
English: Overall, 19% of the patients had previously used topiramate.
Slovenian: Skupno 19 % bolnikov je predhodno uporabljalo topiramat.
English: This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.
Slovenian: Poleg tega zdravilo zmanjša onesposobljenost, povezano z migreno in zmanjša potrebo po zdravilih, ki se uporabljajo za zdravljenje napadov migrene.
English: − Do not touch the needle.
Slovenian: − Ne dotikajte se igle.
English: Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) have not been studied.
Slovenian: Bolnikov s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) niso preučili.
English: The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine.
Slovenian: Zdravljenje mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem migrene.
English: Gently pinch up at least 2.5 cm of the skin that you have cleaned.
Slovenian: Nežno stisnite vsaj 2,5 cm kože, ki ste jo pred tem očistili.
English: Make sure the name AJOVY appears on the label.
Slovenian: Prepričajte se, da je na nalepki navedeno ime AJOVY.
English: The antibody responses were of low titer.
Slovenian: Titer protiteles je bil nizek.
English: One of these 6 patients developed neutralising antibodies.
Slovenian: 6 bolnikov so se razvila nevtralizirajoča protitelesa.
English: 61% of patients completing Study 3 achieved a 50% response in the last month of the study.
Slovenian: bolnikov, ki so dokončali študijo 3, je doseglo 50-odstotni odziv v zadnjem mesecu študije.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo, da bolnika spremljamo glede kakršnih koli znakov ali simptomov neželenih učinkov in po potrebi uvedemo ustrezno simptomatsko zdravljenje.
English: Afterwards, use of fremanezumab could be considered during breast-feeding only if clinically needed.
Slovenian: Po tem se lahko o uporabi fremanezumaba med dojenjem razmisli le, če je to klinično potrebno.
English: Frequency categories are based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Pogostnosti temeljijo na naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
English: It should not be administered by the intravenous or intramuscular route.
Slovenian: Zdravila se ne sme dajati po intravenski ali intramuskularni poti.
English: Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.
Slovenian: Uporabite nekakšen opomnik, na primer beležke na koledarju ali v dnevniku, da si boste lažje zapomnili, kdaj je čas za naslednji odmerek, tako da ga ne boste pozabili ali si odmerek dali prehitro po zadnjem.
English: No data on exposure-efficacy relationship in subjects with body weight >132 kg is available.
Slovenian: Podatki o razmerju med izpostavljenostjo in učinkovitostjo pri preskušancih s telesno maso > 132 kg niso na voljo.
English: AJOVY reduces the frequency of migraine attacks and days with headache.
Slovenian: Zdravilo AJOVY zmanjša pogostnost migrenskih napadov in dni z glavobolom.
English: − After you have injected all of the medicine, pull the needle straight out.
Slovenian: − Ko ste injicirali vse zdravilo, takoj izvlecite iglo.
English: Pharmacotherapeutic group: Not yet assigned.
Slovenian: Farmakoterapevtska skupina: še ni bila dodeljena.
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Slovenian: Bolnike z nekaterimi hudimi srčno-žilnimi boleznimi so izključili iz kliničnih študij (glejte poglavje 5.1).
English: No formal clinical drug interaction studies have been performed with AJOVY.
Slovenian: Uradnih kliničnih študij medsebojnega delovanja z zdravilom AJOVY niso izvedli.
English: No safety signal was observed during the 15-month combined treatment period.
Slovenian: Med skupno 15-mesečnim obdobjem zdravljenja niso opazili nobenih opozorilnih signalov v zvezi z varnostjo.
English: Approximately 52% of the patients in the study had acute headache medication overuse.
Slovenian: Približno 52 % bolnikov v študiji je zdravila za zdravljenje akutnega glavobola uporabljalo prekomerno.
English: It is unknown whether fremanezumab is excreted in human milk.
Slovenian: Ni znano, ali se fremanezumab izloča v materino mleko.
English: − Do not touch the needle shield area.
Slovenian: − Ne dotikajte se območja ščitnika igle.
English: AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.
Slovenian: Uporaba zdravila AJOVY ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let, saj zdravila pri tej starostni skupini niso proučevali.
English: Slowly push the plunger in.
Slovenian: Počasi potisnite bat.
English: For further instructions on administration, see section 6.6.
Slovenian: Za podrobnejša navodila o dajanju zdravila glejte poglavje 6.6.
English: Elderly patients (>70 years), patients using opioids or barbiturates on more than 4 days per month, and patients with pre-existing myocardial infarction, cerebrovascular accident, and thromboembolic events were excluded.
Slovenian: Starejše bolnike (> 70 let), bolnike, ki so uporabljali opioide ali barbiturate več kot 4 dni na mesec, in bolnike, pri katerih so se že kdaj pojavili miokardni infarkt, cerebrovaskularni insult in trombembolični dogodki, so izključili.
English: Pain, induration and erythema were typically observed immediately after injection while pruritus and rash appeared within a median of 24 and 48 hours, respectively.
Slovenian: Bolečino, induracijo in eritem so običajno opazili takoj po injiciranju, medtem ko se je pruritus pojavil v medianem času 24 ur, izpuščaj pa v medianem času 48 ur.
English: You and your doctor should decide if you will use AJOVY while breast-feeding.
Slovenian: Skupaj z zdravnikom se boste odločili, ali boste zdravilo AJOVY uporabljali med dojenjem.
English: Other medicines and AJOVY
Slovenian: Druga zdravila in zdravilo AJOVY
English: The detailed instructions for use provided at the end of the package leaflet must be followed step-bystep carefully.
Slovenian: Podrobna navodila za uporabo, ki so na koncu navodila za uporabo, je treba natančno upoštevati korak za korakom.
English: This medicine is not expected to have any effect on your ability to drive or use machines.
Slovenian: Ni pričakovati, da bi to zdravilo imelo vpliv na vašo sposobnost upravljanja vozil in strojev.
English: A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine.
Slovenian: Snov v telesu, imenovana gen za kalcitonin (CGRP - calcitonin gene-related peptide), ima pomembno vlogo pri migreni.
English: The following mild to moderate, short-lasting skin reactions around the injection area can occur:
Slovenian: Pojavijo se lahko naslednje blage do zmerne, kratkotrajne kožne reakcije okoli mesta injiciranja:
English: The marketing authorisation holder shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: There are no fertility data in humans.
Slovenian: Podatki o plodnosti pri ljudeh niso na voljo.
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Slovenian: Po tem se priporoča redna ocena potrebe po zdravljenju.
English: AJOVY should not be used if the solution has been frozen.
Slovenian: Zdravila AJOVY ne smete uporabiti, če je bila raztopina zamrznjena.
English: − Clean the chosen injection area using a new alcohol swab.
Slovenian: − Očistite izbrani predel injiciranja z novo alkoholno blazinico.
English: It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known.
Slovenian: Uporabi zdravila AJOVY med nosečnostjo se je bolje izogniti, saj učinki zdravila pri nosečnicah niso znani.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with AJOVY in one or more subsets of the paediatric population in prevention of migraine headaches (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom AJOVY za eno ali več podskupin pediatrične populacije za preprečevanje migrenskih glavobolov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Hypersensitivity reactions were reported with fremanezumab in less than 1% of patients in clinical trials.
Slovenian: O preobčutljivostnih reakcijah pri uporabi fremanezumaba so poročali pri manj kot 1 % bolnikov v kliničnih preskušanjih.
English: (95% CI)
Slovenian: (95-odstotni IZ)
English: AJOVY has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo AJOVY nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The formed small peptides and amino acids may be re-used in the body for de novo synthesis of proteins or are excreted by the kidney.
Slovenian: Majhne peptide in aminokisline, ki nastanejo, lahko telo ponovno uporabi za sintezo beljakovin de novo ali pa se izločijo skozi ledvice.
English: The most frequently observed local reactions at the injection site were pain, induration and erythema.
Slovenian: Lokalne reakcije na mestu injiciranja, ki so jih najpogosteje opazili, so bile bolečina, induracija in eritem.
English: Fremanezumab has an estimated half-life of 30 days.
Slovenian: Ocenjeni razpolovni čas fremanezumaba je 30 dni.
English: When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen.
Slovenian: Če zamenjamo režim odmerjanja, je treba prvi odmerek po novem režimu dati na datum načrtovanega naslednjega odmerka po prejšnjem režimu.
English: CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.
Slovenian: Dokazano je, da se ravni CGRP med migreno pomembno povišajo, ko glavobol popusti, pa se vrnejo na normalno raven.
English: All local injection site reactions were transient and predominantly mild to moderate in severity.
Slovenian: Vse lokalne reakcije na mestu injiciranja so bile prehodne in v glavnem blage do zmerne.
English: If your dose is 675 mg, inject the three injections one after another, each in a different place.
Slovenian: Če je vaš odmerek 675 mg, si injicirajte tri injekcije eno za drugo, vsako v različno mesto.
English: Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and migraine preventive medicinal products during the clinical studies did not affect the pharmacokinetics of fremanezumab.
Slovenian: Poleg tega sočasna uporaba zdravil za zdravljenje akutne migrene (natančneje analgetikov, alkaloidov ergot in triptanov) in zdravil za preprečevanje migrene v kliničnih študijah ni vplivala na farmakokinetiko fremanezumaba.
English: While the precise mechanism of action by which fremanezumab prevents migraine attacks is unknown, it is believed that prevention of migraine is obtained by its effect modulating the trigeminal system.
Slovenian: Točen mehanizem delovanja, preko katerega fremanezumab preprečuje migrenske napade, ni znan, vendar domnevamo, da migreno prepreči z učinkom, ki ga ima na uravnavanje trigeminalnega sistema.
English: You hear a second “click” (about 15 seconds after the first “click”; the plunger will be moving to the bottom of the viewing window as the medicine is being injected).
Slovenian: Zaslišite drugi »klik« (približno 15 sekund po prvem »kliku«; bat se bo med injiciranjem zdravila pomikal proti dnu pregledovalnega okenca).
English: If you have used more AJOVY than you should, tell your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila AJOVY, kot bi smeli, to povejte zdravniku.