FrancophonIA/ELRC3.0 huggingface dataset:
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Firdapse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Firdapse je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Firdapse is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Firdapse should be taken with food.
Slovenian: Jemlje se v ločenih odmerkih tri ali štiri krat dnevno, posamezni odmerek pa ne sme preseči 20 mg.
English: What benefit has Firdapse shown during the studies?
Slovenian: Kakšne koristi je zdravilo Firdapse izkazalo med študijami?
English: Firdapse is a medicine that contains the active substance amifampridine.
Slovenian: Firdapse je zdravilo, ki vsebuje zdravilno učinkovino amifampridin.
English: Because amifampridine-containing medicines have been used in the European Union (EU) for over 20 years, the company presented the results of studies from the scientific literature on amifampridine to support the use of Firdapse.
Slovenian: Ker se zdravila z zdravilno učinkovino amifampridin v Evropski uniji uporabljajo že več kot dvajset let, je družba v podporo uporabi zdravila Firdapse predstavila rezultate študij o amifampridinu iz znanstvene literature.
English: It must not be used with sultopride (an antipsychotic medicine), or medicines known to cause QTc prolongation (an alteration of the electrical activity of the heart).
Slovenian: Ne sme se uporabljati s sultopridom (antipsihotičnim zdravilom) ali z zdravili, ki povzročajo podaljšanje QTc (spremembe električne aktivnosti srca).
English: Firdapse has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Firdapse je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Firdapse.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Firdapse, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Firdapse in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Acetylcholine is released from the nerve endings during a period of ‘depolarisation'.
Slovenian: Acetilholin se iz živčnih končičev sprošča v fazi „depolarizacije“.
English: The most common side effects reported with Firdapse are paraesthesia (unusual sensations like pins and needles) and gastro-intestinal disorders such as epigastralgia (pain around the upper part of the stomach), diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Firdapse, so parestezija (nenavadni občutki zbadanja) in prebavne motnje, kot so epigastralgija (bolečina v zgornjem delu želodca), driska, navzeja (slabost) in bolečine v trebuhu.
English: Additionally, the effect of Firdapse on the QT interval (the electrical activity of the heart) was investigated.
Slovenian: Poleg tega so proučevali učinek zdravila Firdapse na interval QT (električna aktivnost srca).
English: The full EPAR for Firdapse can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Firdapse je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Firdapse must not be used in patients who have epilepsy or in patients with uncontrolled asthma or congenital QT syndromes (disruption of the heartbeat).
Slovenian: Zdravila Firdapse ne smejo uporabljati bolniki z epilepsijo, ali bolniki z neobvladovano astmo oziroma kongenitalnimi sindromi QT (motnjami srčnega ritma).
English: For the full list of all side effects and restrictions with Firdapse, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Firdapse glejte navodilo za uporabo.
English: Because the number of patients with LEMS is low, the disease is considered ‘rare', and Firdapse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Slovenian: Ker je bolnikov z Lambert-Eatonovim miastenijskim sindromom malo, velja ta bolezen za redko, zato je bilo zdravilo Firdapse dne 18. decembra 2002 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: In the QT study, amifampridine was observed to have no effects on the activity of the heart, as shown by the electrocardiograms of healthy volunteers taking part in this study.
Slovenian: V študiji vpliva na električno aktivnost srca so ugotovili, da amifampridin ne vpliva na dejavnost srca, kar so v okviru te študije dokazali z elektrokardiogrami zdravih prostovoljcev.
English: Why has Firdapse been approved?
Slovenian: Zakaj je bilo zdravilo Firdapse odobreno?
English: What information is still awaited for Firdapse?
Slovenian: Katere informacije o zdravilu Firdapse še pričakujemo?
English: The active substance in Firdapse, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells.
Slovenian: Zdravilna učinkovina zdravila Firdapse, amifampridin, je zaviralec kalijevih kanalčkov, ki preprečuje potovanje nabitih kalijevih delcev iz živčnih celic.
English: The CHMP decided that Firdapse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Firdapse večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The main measures of effectiveness were based on the rating of how well the muscles worked using a scoring system, either the neurological disability score (NDS) or the quantitative myasthenia gravis (QMG) score.
Slovenian: Glavna merila učinkovitosti so temeljila na merjenju učinkovitosti delovanja mišic po točkovnem sistemu: oceni nevrološke okvare ali kvantitativni oceni miastenije gravis.
English: In two published studies involving a total of 38 adults with LEMS, amifampridine was compared with placebo (a dummy treatment).
Slovenian: V dveh objavljenih študijah, v kateri je bilo vključenih 38 odraslih z Lambert-Eatonovim miastenijskim sindromom, so amifampridin primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: How has Firdapse been studied?
Slovenian: Kako je bilo zdravilo Firdapse raziskano?
English: This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract.
Slovenian: Zato se faza depolarizacije podaljša in se lahko acetilholin dlje sprošča iz živcev ter tako spodbuja krčenje mišic.
English: In one study, the NDS was reduced from 40 to 22 points in patients taking Firdapse compared with a drop to 35 points in patients taking placebo.
Slovenian: V eni študiji se je pri bolnikih, ki so jemali zdravilo Firdapse, ocena nevrološke okvare znižala s 40 na 22 točk, pri bolnikih, ki so jemali placebo, pa na 35 točk.
English: For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine.
Slovenian: Da se mišice krčijo, morajo živci prek kemijskega prenašalca, imenovanega acetilholin, do njih prenesti električne impulze.
English: LEMS is a disease in which patients have muscle weakness because of a failure of the nerves to transmit electrical impulses to the muscles.
Slovenian: To je bolezen, ki se kaže z mišično šibkostjo, ki nastane zaradi motnje prenosa električnih impulzov po živcih do mišic.
English: Firdapse is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Slovenian: Zdravilo Firdapse se uporablja za zdravljenje odraslih s simptomi Lambert-Eatonovega miastenijskega sindroma (LEMS).
English: In the third combined study, patients taking Firdapse had better improvements in CMAP than patients taking placebo.
Slovenian: V tretji kombinirani študiji se je sestavljeni mišični akcijski potencial pri bolnikih, ki so jemali zdravilo Firdapse, izboljšal bolj kot pri bolnikih, ki so jemali placebo.
English: What is Firdapse used for?
Slovenian: Za kaj se zdravilo Firdapse uporablja?
English: CMAP is a measure of electrical activity in muscles.
Slovenian: Sestavljeni mišični akcijski potencial je merilo električne aktivnosti mišic.
English: Firdapse was more effective than placebo at treating patients with LEMS.
Slovenian: Zdravilo Firdapse je bilo učinkovitejše od placeba pri zdravljenju bolnikov z Lambert-Eatonovim miastenijskim sindromom.
English: Treatment with Firdapse should only be started under the supervision of a doctor experienced in treating LEMS.
Slovenian: Zdravljenje z zdravilom Firdapse se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem Lambert-Eatonovega miastenijskega sindroma.
English: Patients with lower NDS or QMG scores have better muscle function.
Slovenian: Pri bolnikih z nižjo oceno nevrološke okvare ali nižjo kvantitativno oceno miastenije gravis mišice delujejo bolje.
English: The other study showed a reduction in the QMG score of 2 points in patients taking Firdapse compared with a rise of 0.25 points in patients taking placebo.
Slovenian: V drugi študiji se je pri bolnikih, ki so jemali zdravilo Firdapse, kvantitativna ocena miastenije gravis znižala za 2 točki, medtem ko se je pri bolnikih, ki so jemali placebo, zvišala za 0,25 točke.
English: Additionally, the company that markets Firdapse has been required to set up a patient registry for patients with LEMS.
Slovenian: Poleg tega mora družba, ki trži zdravilo Firdapse, pripraviti register bolnikov z Lambert-Eatonovim miastenijskim sindromom.
English: How is Firdapse used?
Slovenian: Kako se zdravilo Firdapse uporablja?
English: What is Firdapse?
Slovenian: Kaj je zdravilo Firdapse?
English: How does Firdapse work?
Slovenian: Kako zdravilo Firdapse deluje?
English: Date of first authorisation: 29 November 2010 Date of latest renewal: 17 July 2015
Slovenian: Datum prve odobritve: 29. november 2010 Datum zadnjega podaljšanja: 17. julij 2015
English: Some effects mentioned under section 4.
Slovenian: Nekateri učinki, navedeni v poglavju 4.
English: 1105BJ Amsterdam Netherlands
Slovenian: 1105BJ Amsterdam Nizozemska
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy.
Slovenian: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italija
English: • if you have a severe infection with a high temperature (over 38°C).
Slovenian: • če imate hudo okužbo z visoko telesno temperaturo (več kot 38 °C).
English: Similar trends were observed for seroprotection rates in both studies.
Slovenian: Podobne trende so opazili tudi pri stopnjah serozaščite v obeh študijah.
English: Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Slovenian: Takojšnje analize kumulativnih podatkov o varnosti, v luči obsega izpostavljenosti, bodo odločilne za regulatorne odločitve in zaščito populacije, ki bo cepljena.
English: HI results for the two clinical studies revealed lower values than those reported in previous studies.
Slovenian: Rezultati HI iz obeh kliničnih študij so pokazali nižje vrednosti od tistih, o katerih so poročali v prejšnjih študijah.
English: In the first few weeks after vaccination with AFLUNOV the results of these tests may not be correct.
Slovenian: V prvih tednih po cepljenju s cepivom AFLUNOV so lahko rezultati testov napačni.
English: - Adjuvant MF59C.1:
Slovenian: - Adjuvans MF59C.1:
English: Vaccination is currently not recommended in this age group.
Slovenian: Cepljenje pri tej starostni skupini trenutno ni priporočeno.
English: Dispose of in accordance with local requirements.
Slovenian: Odstranite v skladu z nacionalnimi zahtevami.
English: - Italy
Slovenian: - Italija
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Slovenian: Takšne razmere zahtevajo hitro obveščanje o varnostnih informacijah, ki lahko najpomembneje vplivajo na razmerje med koristjo in tveganjem med pandemijo.
English: Clinical trials in special populations
Slovenian: Klinična preskušanja pri posebnih populacijah
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Slovenian: • če ste imeli krvni pregled zaradi znakov okužbe z nekaterimi virusi.
English: • Generalised skin reactions including
Slovenian: • Generalizirana kožna reakcija, vključno s:
English: Periodic Safety Update Reports (PSURs)
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR)
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation 726/2004/EC will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Slovenian: Med pandemskimi razmerami pogostnost predložitve poročil o varnosti zdravila, ki je določena v členu 24 Uredbe 726/2004/ES, ne bo zadostovala za spremljanje varnosti pandemičnega cepiva, za katerega se v kratkem času pričakuje visoka stopnja izpostavljenosti.
English: • Severe stabbing or throbbing pain along one or more nerves
Slovenian: • močna zbadajoča ali utripajoča bolečina vzdolž enega ali več živcev,
English: Immunogenicity was assessed in 182 subjects.
Slovenian: Imunogenost so ocenili pri 182 osebah.
English: N=145 N=149 N=59 N=58 N=147 N=148 N=58 N=62
Slovenian: Število preskušancev N = 145 N = 149 N = 59 N = 58 N = 147 N = 148 N = 58 N = 62
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki pri preiskovancih, starih od 6 mesecev do 18 let,so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Slovenian: Zdravniki poznajo to možnost, zato imajo za take primere pripravljeno nujno medicinsko pomoč.
English: Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.
Slovenian: Nekateri neželeni učinki, navedeni v poglavju 4.8, lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be taken by a state laboratory or a laboratory designated for that purpose.
Slovenian: V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: Human infections are primarily caused by contact with infected animals, but do not spread easily between people.
Slovenian: Ljudje se ponavadi okužijo pri stiku z okuženimi živalmi, okužba pa se med ljudmi ne prenaša zlahka.
English: There is limited experience in elderly over 70 years of age (see section 5.1).
Slovenian: Pri starejših od 70 let so izkušnje omejene (glejte poglavje 5.1).
English: There are no data concerning human fertility.
Slovenian: Ni podatkov v zvezi s plodnostjo pri človeku.
English: A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with AFLUNOV;
Slovenian: Blažja okužba kot je prehlad ne predstavlja težave, vendar vam bosta zdravnik ali medicinska sestra svetovala, ali se lahko še vedno cepite s cepivom AFLUNOV,
English: Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Slovenian: Zdravstveni delavci morajo oceniti koristi in možna tveganja cepljenja nosečih žensk ob upoštevanju uradnih priporočil.
English: The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Slovenian: Odstotek oseb, ki so poročale o lokalnih reakcijah, je bil višji v skupini s starejšimi bolniki, pretežno zaradi več poročil o bolečinah.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Slovenian: Preden se cepite, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: A second dose of 0.5 ml should be given after an interval of at least 3 weeks.
Slovenian: Drugi odmerek 0,5 ml cepiva je treba dati po presledku vsaj 3 tednov.
English: None of the ingredients in the vaccine can cause flu.
Slovenian: Nobena sestavina cepiva ne more povzročiti gripe.
English: In addition, antibody responses in patients with endogenous or iatrogenic immunosuppression may be insufficient to provide protection.
Slovenian: Poleg tega je protitelesni odziv pri bolnikih z endogeno ali iatrogeno zmanjšanim imunskim odzivom lahko nezadosten za zagotovitev zaščite.
English: The magnitude of immune response was lower in the group who received the 2nd dose 1 week later and higher in the groups with longer interval schedules.
Slovenian: Moč imunskega odziva je bila nižja v skupini, ki je prejela 2. odmerek 1 teden kasneje in višja v skupini z daljšimi režimi presledkov.
English: The suspension is a milky-white liquid.
Slovenian: Suspenzija je mlečno-bela tekočina.
English: - Other ingredients:
Slovenian: - Druge sestavine zdravila:
English: Available data in paediatric population
Slovenian: Razpoložljivi podatki za pediatrično populacijo
English: Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Slovenian: Farmakoterapevtska skupina: Cepivo proti gripi, oznaka ATC: J07BB02.
English: AFLUNOV should be used in accordance with official recommendations.
Slovenian: Cepivo AFLUNOV je treba uporabljati v skladu z uradnimi priporočili.
English: In addition, the side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent seasonal flu.
Slovenian: Dodatno so se učinki, opisani v nadaljevanju, pojavili v dnevih in tednih po cepljenju s cepivi, ki se rutinsko uporabljajo vsako leto za preprečevanje sezonske gripe.
English: However, the degree of protection that may be elicited to H5N1 strains of other clades is unknown (see section 5.1).
Slovenian: Vendar pa stopnja zaščite pred sevi H5N1 iz drugih gruč ni znana (glejte poglavje 5.1).
English: In consequence, as soon as the pandemic is declared and the zoonotic vaccine is used, the Marketing Authorisation Holder (MAH) shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the “CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context” (EMEA/49993/2008), and any subsequent update.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zato takoj po razglasitvi pandemije in uporabi zoonotskega cepiva pogosteje predajati redna poenostavljena posodobljena poročila o varnosti zdravila v obliki in s pogostnostjo, opredeljeni v „CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context“ (EMEA/49993/2008) in v vseh nadaljnjih dopolnitvah.
English: It is important that procedures are in place to avoid injury from faints
Slovenian: Pomembno je, da se postopek opravi na mestu, kjer se je možno izogniti poškodbam zaradi omedlevice.
English: Any unused vaccine and waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Slovenian: Po cepljenju se lahko pojavijo alergijske reakcije, ki v redkih primerih vodijo v šok.
English: Vaccination protected animals from lethal challenge even when HI antibody titres were low or undetectable.
Slovenian: Cepljenje je zaščitilo živali pred letalno provokacijo tudi, ko so bili titri protitelesa HI nizki ali nedoločljivi.
English: • extensive swelling of injected limb lasting more than one week.
Slovenian: • Obsežna oteklina okončine, v katero je bilo injicirano cepivo, ki traja več kot en teden.
English: Tell your doctor if you have a weak immune system or an underlying long term medical problem.
Slovenian: Obvestite zdravnika, če imate oslabljen imunski sistem ali dolgotrajno osnovno bolezensko stanje.
English: The vaccine should never be given into a vein.
Slovenian: Cepivo se ne sme nikoli injicirati v veno.
English: Alternative vaccination schedules:
Slovenian: Drugi režimi cepljenja:
English: It should be noted that the adverse reactions may be intensified.
Slovenian: Opozoriti je treba, da so lahko neželeni učinki izrazitejši.
English: In addition, duration a pandemic, resources needed for an in-depth evaluation of PSURs in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Slovenian: Poleg tega med trajanjem pandemije viri, potrebni za poglobljeno vrednotenje PSUR v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti „Rules Governing Medicinal Product in the European Union - Volume 9a“ morda ne bodo zadostovali za hitro identifikacijo novih varnostnih izsledkov.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before receiving this vaccine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se pred cepljenjem s tem cepivom posvetujte z zdravnikom ali medicinsko sestro.
English: Irrespective of antigen dose, almost all systemic reactions were reported on the day of vaccination (day 1) or during the 3 days immediately following.
Slovenian: Ne glede na odmerek antigena so o skoraj vseh sistemskih neželenih učinkih poročali na dan cepljenja (1. dan) ali v 3 dneh naslednjih dneh.
English: Efficacy against challenge with the heterologous virus A/Indonesia/5/2005 was also tested.
Slovenian: Testirali so tudi učinkovitost proti provokaciji s heterolognim virusom seva A/Indonesia/5/2005.
English: There is limited experience in elderly over 70 years of age.
Slovenian: Pri starejših od 70 let so izkušnje omejene.
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Slovenian: Zato morajo zdravstveni delavci oceniti prednosti in možna tveganja, povezana z dajanjem cepiva, pri bolnikih s trombocitopenijo ali motnjami krvavitev, ki kontraindicirajo intramuskularno injiciranje, razen kadar so možne koristi večje od tveganja krvavitev.
English: There were 3872 subjects 18-60 years of age, 365 subjects 61-70 years of age, and 89 subjects greater than 70 years of age.
Slovenian: 3.872 oseb je bilo starih med 18 in 60 let, 365 oseb med 61 in 70 let in 89 oseb je bilo starejših od 70 let.