FrancophonIA/ELRC3.0 huggingface dataset:
English: Other findings already seen for other antisense oligonucleotides, like elevation of transaminases have also been identified.
Croatian: Također su utvrđeni drugi rezultati koji su već uočeni za druge antisense oligonukleotide (inhibitore ekspresije gena), kao što je povećanje transaminaza.
English: Comparison with untreated patients is challenging as only 4 patients were on placebo for 24 weeks.
Croatian: Usporedba s neliječenim bolesnicima predstavlja izazov jer su samo četiri bolesnika primala placebo tijekom 24 tjedna.
English: Additional post-hoc comparisons with other external controls also have their limitations, as previously mentioned.
Croatian: Kako je prethodno spomenuto, dodatne naknadne usporedbe s vanjskim kontrolnim skupinama također imaju ograničenja.
English: All patients (100%) included in the pivotal trial and around 50% of all patients treated with any dose of eteplirsen reported AEs, mainly hypokaliemia, dermatitis contact, oropharyngeal pain, procedural pain, vomiting, balance disorder and cough.
Croatian: Svi bolesnici (100 %) obuhvaćeni ključnim ispitivanjem i oko 50 % svih bolesnika liječenih bilo kojom dozom lijeka eteplirsen prijavili su štetne događaje, većinom hipokalijemiju, kontaktni dermatitis, bol u ustima i grlu (orofaringealnu bol), bol tijekom medicinskih postupaka (proceduralnu bol), povraćanje, poremećaj ravnoteže i kašalj.
English: The assessment of the safety profile of eteplirsen was hampered by the limitations of the safety database.
Croatian: Ocjenjivanje sigurnosnog profila lijeka eteplirsen otežana je zbog ograničenja baze podataka o sigurnosti lijeka.
English: • Due to the limited number of patients exposed to eteplirsen the safety profile remains not thoroughly characterised.
Croatian: • S obzirom na ograničeni broj bolesnika izloženih lijeku eteplirsen, sigurnosni profil lijeka i dalje nije podrobno karakteriziran.
English: The main limitations in the dataset arise from the limited number of patients by arm (which hinder the interpretability of the study results), and from the duration of the placebo-controlled phase (6 months).
Croatian: Glavna ograničenja u skupu podataka proizlaze iz ograničenog broja bolesnika po skupini (što otežava mogućnost tumačenja rezultata ispitivanja) i iz trajanja faze kontrolirane placebom (šest mjeseci).
English: • It remains unknown whether expression of the observed very low amount of truncated dystrophin after treatment with eteplirsen can translate into any clinical benefit to patients.
Croatian: • I dalje nije poznato može li ekspresija vrlo niske razine skraćenog distrofina koja je uočena nakon liječenja lijekom eteplirsen postati klinička korist za bolesnike.
English: • Efficacy issues
Croatian: • Pitanja djelotvornosti
English: Although the evidence of truncated dystrophin production may support the mechanism of action of the product, convincing demonstration of sustained functional effect is necessary to support the claim for efficacy of the medicinal product in the intended indication.
Croatian: Iako dokazi o proizvodnji skraćenog distrofina mogu ići u prilog mehanizmu djelovanja lijeka, potrebna je uvjerljiva demonstracija dugoročnog funkcionalnog učinka kojom bi se podržala tvrdnja o djelotvornosti lijeka pri predviđenoj indikaciji.
English: There are no comparative data with patients on placebo beyond 24 weeks, and the available data for patients on treatment are derived from only a limited number of patients (n=12).
Croatian: Ne postoje komparativni podatci s bolesnicima koji su primali placebo dulje od 24 tjedna, a dostupni podatci za bolesnike na liječenju izvedeni su na temelju ograničenog broja bolesnika (n=12).
English: Both groups (eteplirsen treated patients and untreated external controls) experienced a decline in ambulation.
Croatian: Obje skupine (bolesnici liječeni lijekom eteplirsen i neliječene vanjske kontrolne skupine) doživjele su pogoršanje sposobnosti hodanja.
English: Longer comparisons (up to 4 years) with 12 DMD patients on eteplirsen were subsequently performed versus two post-hoc defined, external and non-concurrent cohorts (Italian Telethon DMD Registry and Leuven Neuromuscular Reference Center Registry) in an open label extension study.
Croatian: Naknadno su provedene dulje usporedbe (do četiri godine) s 12 bolesnika koji pate od DMD-a i primaju eteplirsen u odnosu na dvije naknadno definirane, vanjske, nekonkurentne skupine (Italian Telethon DMD Registry i Leuven Neuromuscular Reference Center Registry) u produžetku otvorenog ispitivanja.
English: In conclusion, the safety profile of eteplirsen has not been thoroughly characterized.
Croatian: Zaključno, sigurnosni profil lijeka eteplirsen nije podrobno karakteriziran.
English: The CHMP considered that with the currently available data it is not possible to conclude that the benefit/risk balance of eteplirsen is positive in DMD patients with mutations amenable to exon 51 skipping, since:
Croatian: CHMP je zaključio da na temelju trenutačno dostupnih podataka nije moguće zaključiti da je omjer koristi i rizika lijeka eteplirsen pozitivan u bolesnika s DMD-om s mutacijama koje mogu dovesti do preskakanja egzona 51 jer:
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the proposed SmPC.
Croatian: Kvaliteta lijeka smatra se prihvatljivom kada se primjenjuje u skladu s uvjetima utvrđenima u predloženom sažetku opisa svojstava lijeka.
English: A comparison versus a different external and non-concurrent cohort was provided (DMD patients on placebo from the pivotal trial of another medicinal product) for both the whole population and that restricted to those DMD patients walking between 300 and 450 m., and similar shortcomings regarding the comparison groups were identified there.
Croatian: Provedena je usporedba u odnosu na različitu vanjsku i nekonkurentnu skupinu (bolesnici koji pate od DMD-a koji primaju placebo iz ključnog ispitivanja drugog lijeka) za čitavu populaciju i populaciju ograničenu na bolesnike koji pate od DMD-a koji hodaju između 300 i 450 m te su tu uočene slične manjkavosti u pogledu usporednih skupina.
English: The limitation of the database size does not allow for the identification of frequent AEs (≥10%) and the lack of a comparator placebo arm makes it impossible to distinguish between AEs related to the disease or the age of the population and those related to the drug.
Croatian: Ograničenje veličine baze podataka onemogućuje identifikaciju učestalih štetnih događaja (≥10 %), a nepostojanje skupine kontrolirane placebom onemogućuje razlikovanje između štetnih događaja povezanih s dobi populacije i onih povezanih s lijekom.
English: For this application clinical data were provided from a randomized, double-blinded, placebo controlled 24week Phase IIb study (study 201) and its open label extension Study 202 in a total of 12 DMD patients.
Croatian: Za ovaj zahtjev dostavljeni su klinički podatci iz nasumičnog, dvostruko slijepog, placebom kontroliranog 24-tjednog ispitivanja u fazi II.b (ispitivanje 201) i njegova produžetka otvorenog ispitivanja, ispitivanja 202, na ukupno 12 bolesnika koji pate od DMD-a.
English: One myocardytis event with an atypical presentation was identified in one patient on eteplirsen 30 mg/kg.
Croatian: Jedan slučaj miokarditisa s netipičnim simptomima utvrđen je u jednog bolesnika koji je primao 30 mg/kg lijeka eteplirsen.
English: The primary analysis of this pivotal trial provided a 24-week comparison of only 4 patients on eteplirsen exposed to the proposed dose of 30mg/kg/week versus placebo (n=4), and additionally 4 patients exposed to 50 mg/kg/week, in which no difference was observed in the 6MWD.
Croatian: Primarnom analizom ovog ključnog ispitivanja omogućena je 24-tjedna usporedba samo četiriju bolesnika koji su primali eteplirsen i bili izloženi predloženoj dozi od 30 mg/kg/tjedno u odnosu na placebo (n=4) te dodatnih četiriju bolesnika izloženih 50 mg/kg/tjedno, pri čemu nije uočena razlika u 6MWD.
English: A trend favouring eteplirsen treated patients was observed in loss of ambulation (2/12 in eteplirsen treated patients vs. 10/13 in external controls at Year 4), North Star Ambulatory Assessment and ability to rise from supine.
Croatian: Trend u korist bolesnika liječenih lijekom eteplirsen (2/12 u bolesnika liječenih lijekom eteplirsen u odnosu na 10/13 u vanjskim kontrolnim skupinama u 4. godini) uočen je u pogledu gubitka sposobnosti hoda, procjene sposobnosti hodanja North Star i sposobnosti ustajanja iz ležećeg položaja.
English: There are data available from the extension study 202 in which only 6 patients were treated with eteplirsen, 30 mg/kg and 6 with eteplirsen 50 mg/kg for approximately 3 additional years.
Croatian: Dostupni su podatci iz proširenog ispitivanja 202, u kojemu je samo šest bolesnika bilo liječeno lijekom eteplirsen 30 mg/kg, a šest lijekom eteplirsen 50 mg/kg tijekom približno tri dodatne godine.
English: For the long-term safety assessment, safety data are available only for a small set of patients (6 on eteplirsen 30 mg/kg and 6 on 50 mg/kg).
Croatian: Za potrebe ocjene dugoročne sigurnosti lijeka, podatci o sigurnosti dostupni su samo za mali skup bolesnika (šest koji su uzimali 30 mg/kg lijeka eteplirsen i šest koji su uzimali eteplirsen u dozi od 50 mg/kg).
English: A more pronounced deterioration was observed in the external control groups (both the amenable to exon 51 skipping control group and the one including amenable to any exon skipping patients) than in eteplirsen treated patients.
Croatian: Naglašenije pogoršanje uočeno je u vanjskim kontrolnim skupinama (kako u kontrolnoj skupini u kojoj se preskakao egzon 51, tako i u kontrolnoj skupini s bolesnicima u kojih se preskakao bilo koji egzon) nego u bolesnika liječenih lijekom eteplirsen.
English: The only comparative data comes from study 201 (n=12) in which 4 subjects were randomized to 30 mg/kg, 4 to 50 mg/kg and 4 to placebo for 24 weeks.
Croatian: Jedini usporedivi podatci dobiveni su u ispitivanju 201 (n=12), u kojemu je četvero nasumično odabranih ispitanika primalo 30 mg/kg, četvero 50 mg/kg, dok je četvero primalo placebo tijekom 24 tjedna.
English: Interim analysis became available for one of them, the PROMOVI (study 301) an open-label, multicentre study performed in DMD patients with genetically confirmed DMD with exon deletions amenable to exon 51 skipping.
Croatian: Za jedno od njih, PROMOVI (ispitivanje 301), otvoreno, multicentrično ispitivanje provedeno na bolesnicima koji pate od DMD-a s genetski potvrđenim DMD-om s brisanjem egzona kod kojeg se može preskakati egzon 51, postala je dostupna privremena analiza.
English: The comparison was done with an untreated control arm of DMD patients amenable to exon skipping of an exon other than exon 51.
Croatian: Provedena je usporedba s neliječenom kontrolnom skupinom bolesnika s DMD-om u kojih se preskakao egzon koji nije egzon 51. Nisu postojale značajne razlike u kliničkim ishodima između bolesnika liječenih lijekom eterplirsen i onih koji nisu bili liječeni.
English: • Safety issues
Croatian: • Pitanja sigurne primjene
English: This summary was last updated in February 2017.
Croatian: Ovaj sažetak je posljednji put ažuriran u veljači 2017.
English: The dose to be used depends on the weight of the dog being treated.
Croatian: Veličina doze ovisi o težini liječenog psa.
English: The full EPAR for Cytopoint can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Cytopoint nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Once the dog's skin becomes damaged by scratching and rubbing, secondary bacterial and yeast infections may develop as well.
Croatian: Nakon što dođe do oštećenja kože psa zbog grebanja i trljanja, mogu se razviti i sekundarne bakterijske te gljivične infekcije.
English: Cytopoint starts to be effective within eight hours of injection and the effect lasts for up to 28 days.
Croatian: VMP Cytopoint postaje djelotvoran unutar osam sati od injekcije, a učinak traje do 28 dana.
English: Repeated accidental self-injection may cause an allergic reaction to the medicine.
Croatian: Opetovano nehotično samoinjektiranje može prouzročiti alergijsku reakciju na VMP.
English: Cytopoint is a veterinary medicine used to treat atopic dermatitis in dogs.
Croatian: Cytopoint je veterinarsko-medicinski proizvod koji se koristi za liječenje atopijskog dermatitisa u pasa.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja treba odmah potražiti liječnički savjet i pokazati uputu o proizvodu ili etiketu.
English: Atopic dermatitis is inflammation of the skin that is linked to allergy, often to things in the environment such as house dust mites and pollens.
Croatian: Atopijski dermatitis je kožna upala povezana s alergijom, često sa sastojcima iz okoliša kao što su kućne grinje iz prašine i pelud.
English: What is Cytopoint and what is it used for?
Croatian: Što je Cytopoint i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the EU for Cytopoint on 25 April 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Cytopoint na snazi u Europskoj uniji od 25/04/2017.
English: By blocking interleukin 31, lokivetmab reduces itchy skin and inflammation.
Croatian: Blokiranjem proteina interleukin-31 lokivetmab smanjuje svrbež kože i upalu.
English: Lokivetmab is a monoclonal antibody (a type of protein) that recognises and attaches to interleukin-31, a protein that plays an important role in triggering atopic dermatitits in dogs.
Croatian: Lokivetmab je monoklonsko protutijelo (vrsta proteina) koje prepoznaje te se veže uz interleukin-31, protein koji ima važnu ulogu u aktivaciji atopijskog dermatitisa u pasa.
English: The most common side effects with Cytopoint (which may affect up to 1 in 1,000 animals) are allergic reactions with swelling of the face and itchy rash.
Croatian: Najčešće su nuspojave VMP-a Cytopoint (koje se mogu pojaviti kod 1 od 1 000 životinja) alergijske reakcije s oticanjem lica i osipom koji svrbi.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Cytopoint's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Cytopoint nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: It is not intended to provide practical advice on how to use Cytopoint.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Cytopoint.
English: This is a summary of the European public assessment report (EPAR) for Cytopoint.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Cytopoint.
English: Cytopoint was as effective as ciclosporin in treating itchy skin; after 28 days the pruritus score (measurement of itchiness) was reduced by 52% in dogs given Cytopoint and 44% in those given ciclosporin.
Croatian: VMP Cytopoint bio je jednako djelotvoran kao i ciklosporin u liječenju svrbeža kože; nakon 28 dana stupanj pruritusa (mjerenje svrbeži) smanjio se za 52 % u pasa koji su primili VMP Cytopoint, a 44 % u onih koji su primali ciklosporin.
English: In a field study involving dogs with atopic dermatitis, 142 dogs received Cytopoint monthly for 3 months whilst 132 were treated with ciclosporin, another medicine approved for treating atopic dermatitis.
Croatian: U terenskom ispitivanju koje je obuhvaćalo pse s atopijskim dermatitisom, 142 psa tri su mjeseca primala lijek Cytopoint, dok su 132 psa liječena ciklosporinom, drugim lijekom odobrenim za liječenje atopijskog dermatitisa.
English: The medicine can only be obtained with a prescription.
Croatian: VMP se izdaje samo na recept.
English: Other information about Cytopoint
Croatian: Ostale informacije o VMP-u Cytopoint
English: Cytopoint is available as a solution for injection that is injected under the skin once a month.
Croatian: VMP Cytopoint dostupan je u obliku otopine za injekciju koja se daje supkutano jedanput na mjesec.
English: What are the risks associated with Cytopoint?
Croatian: Koji su rizici povezani s VMP-om Cytopoint?
English: Why is Cytopoint approved?
Croatian: Zašto je VMP Cytopoint odobren?
English: How does Cytopoint work?
Croatian: Kako djeluje Cytopoint?
English: In a follow up study, 81 dogs of the dogs continued Cytopoint treatment for a further six months and the itchy skin score went down further to 14.
Croatian: U naknadnom ispitivanju terapija VMP-om Cytopoint nastavljena je kod 81 psa dodatnih šest mjeseci, a svrbež kože dodatno se smanjio na vrijednost od 14.
English: How is Cytopoint used?
Croatian: Kako se Cytopoint koristi?
English: Over the three months of the study pruritus score went down from a value of 74 at the start to 26 at the end in dogs given Cytopoint.
Croatian: Tijekom tri mjeseca ispitivanja stupanj pruritusa u pasa koji su primili VMP Cytopoint smanjio se s početne vrijednosti od 74 na 26 na kraju ispitivanja.
English: For practical information about using Cytopoint, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Cytopoint vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cytopoint, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a, kao i u uputi o VMP-u Cytopoint nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For more information about treatment with Cytopoint, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Cytopoint vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: What benefits of Cytopoint have been shown in studies?
Croatian: Koje su koristi VMP-a Cytopoint utvrđene u ispitivanjima?
English: Cytopoint contains the active substance lokivetmab.
Croatian: Cytopoint sadrži djelatnu tvar lokivetmab.
English: Cytopoint must not be given to dogs weighing less than 3 kg. For the full list of restrictions and all side effects reported with Cytopoint, see the package leaflet.
Croatian: VMP Cytopoint ne smije se davati psima čija je težina manja od 3 kg.
English: The recommended dose of Fosavance is one tablet once a week.
Croatian: Preporučena doza lijeka Fosavance je jedna tableta jedanput na tjedan.
English: Gradually, the bones become thin and fragile, and more likely to break.
Croatian: Kosti postupno postaju tanke i lomljive, te je vjerojatnije da će se slomiti.
English: The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.
Croatian: Tabletu treba progutati cijelu i ona ne smije biti zdrobljena, sažvakana ili otopljena u ustima.
English: Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s.
Croatian: Alendronatna kiselina je bifosfonat koji se koristi za osteoporozu od sredine 1990.-ih.
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins).
Croatian: Bolesnica mora uzeti tabletu s punom čašom vode (no ne mineralne vode) najmanje 30 minuta prije unosa hrane, pića ili drugih lijekova (uključujući antacide, dodatke kalcija i vitamine).
English: The European Commission granted a marketing authorisation valid throughout the EU for Fosavance on 24 August 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Fosavance na snazi u Europskoj uniji od 24. kolovoza 2005.
English: What measures are being taken to ensure the safe and effective use of Fosavance?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Fosavance?
English: Other information about Fosavance:
Croatian: Ostale informacije o lijeku Fosavance:
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 Fosavance.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Fosavance.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Croatian: Osteoporoza je uobičajenija u žena u postmenopauzi kada se snižavaju koncentracije ženskog hormona estrogena, budući da estrogen pomaže pri održavanju kosti zdravima.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.
Croatian: Budući da bolesnice s osteoporozom možda ne dobivaju dovoljno vitamina D3 izlaganjem Sunčevoj svjetlosti, on je uključen u lijek Fosavance.
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Croatian: Budući da se alendronatna kiselina i vitamin D3 već koriste zasebno u odobrenim lijekovima u Europskoj uniji (EU), tvrtka je dostavila podatke prikupljene u ranijim ispitivanjima kao i iz objavljene literature za žene koje su već u postmenopauzi i koje uzimaju alendronatnu kiselinu i vitamin D kao zasebne tablete.
English: This is a summary of the European public assessment report (EPAR) for Fosavance.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Fosavance.
English: To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Croatian: Kako bi se izbjegao nadražaj jednjaka (cijevi koja vodi od usta do želuca), bolesnica ne smije leći sve do nakon prvog obroka u danu, koji treba biti najmanje 30 minuta nakon uzimanja tablete.
English: The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Fosavance was the same as the dose needed to prevent bone loss.
Croatian: Informacije koje je dostavila tvrtka iz prethodnih ispitivanja i objavljene literature potvrdile su da je doza alendronatne kiseline uključena u Fosavance jednaka dozi potrebnoj za sprječavanje gubitka kostiju.
English: Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight.
Croatian: Vitamin D3 hranjiva je tvar prisutna u pojedinim namirnicama, a proizvodi se i u koži izlaganjem prirodnoj Sunčevoj svjetlosti.
English: A risk management plan has been developed to ensure that Fosavance is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Fosavance.
English: Fosavance reduces the risk of fractures (broken bones) in the spine and the hip.
Croatian: Fosavance smanjuje rizik od fraktura (prijeloma kostiju) kralješnice i kuka.