FrancophonIA/ELRC3.0 huggingface dataset:
English: The SAG also considered that extrapolation of clinical effects in prophylaxis of upper and lower RTI to treatment of these infections, and vice versa was not scientifically justified, which was agreed by CHMP.
Croatian: SAG je smatrao i da ekstrapolacija kliničkih učinaka kod profilakse infekcije gornjeg i donjeg dišnog sustava na liječenje tih infekcija i obrnuto nije znanstveno opravdana, s čime se složio CHMP.
English: • Therefore, the CHMP considered that the benefit-risk balance of bacterial lysates based medicinal products for use in respiratory conditions is unchanged in the prophylaxis setting provided the efficacy and safety of the products are further characterised through the conduct of appropriate phase IV double-blind, multicentre, RCT(s).
Croatian: • Stoga je CHMP smatrao da je omjer koristi i rizika za primjenu lijekova na bazi bakterijskih lizata u okviru profilakse za respiratorna stanja ostao nepromijenjen, pod uvjetom da su djelotvornost i sigurnost lijekova dodatno opisani provedbom odgovarajućeg dvostruko slijepog, multicentričnog randomiziranog kliničkog ispitivanja faze IV.
English: However considering the lack of robust evidence, the conduct of phase IV placebo-controlled, double-blind, multicentre, RCTs according to agreed protocols in order to further characterise the efficacy and safety in their authorised indication(s) should be imposed on the MAs of these products.
Croatian: Međutim, s obzirom na nedostatak čvrstih dokaza, nositeljima odobrenja za stavljanje lijeka u promet trebalo bi nametnuti obvezu provedbe dvostruko slijepih, multicentričnih, randomiziranih placebom kontroliranih kliničkih ispitivanja faze IV. prema dogovorenim protokolima kako bi se dodatno opisale djelotvornost i sigurnost u njihovim odobrenim indikacijama.
English: Ribomunyl is indicated for the prophylaxis of RURTI in children above 2 or 6 years old depending on the presentation, and of recurrent surinfections in chronic bronchitis in adults.
Croatian: Ribomunyl je indiciran za profilaksu ponovljene infekcije gornjeg dišnog sustava u djece starije od dvije ili šest godina, ovisno o dolasku na pregled, i sekundarnih infekcija kod kroničnog bronhitisa u odraslih osoba.
English: Broncho-vaxom is indicated in for the prevention and treatment of RRTI in adults and children.
Croatian: Broncho-Vaxom indiciran je za prevenciju i liječenje ponovljene infekcije dišnog sustava u odraslih i djece.
English: The CHMP considered the benefit-risk balance of the bacterial lysates unchanged in the prophylaxis setting with regard to their authorised subsets of recurrent RTIs.
Croatian: CHMP je smatrao da je omjer koristi i rizika bakterijskih lizata neizmijenjen u okviru profilakse s obzirom na njihove odobrene podskupove rekurentnih infekcija dišnog sustava.
English: Conflicting results were obtained from two double-blind, placebo-controlled RCT evaluating Ismigen in the prophylaxis of LRTI in adults.
Croatian: Proturječni rezultati dobiveni su iz dvaju dvostruko slijepih, randomiziranih placebom kontroliranih kliničkih ispitivanja u kojima je evaluiran Ismigen u pogledu profilakse infekcija donjeg dišnog sustava u odraslih osoba.
English: Therefore, no definite conclusion could be drawn on the efficacy in the prophylaxis indication based on the available data.
Croatian: Stoga na temelju dostupnih podataka nije moguće donijeti konačan zaključak o djelotvornosti u indikaciji za profilaksu.
English: CHMP opinion The CHMP, as a consequence, considers that the benefit-risk balance of bacterial lysates based medicinal products for use in respiratory conditions remains favourable subject to the amendments to the product information and to the conditions described above.
Croatian: Slijedom toga, CHMP smatra da je omjer koristi i rizika lijekova na bazi bakterijskih lizata u primjeni pri respiratornim stanjima i dalje povoljan, uz izmjene informacija o lijeku i pod prethodno opisanim uvjetima.
English: Polyvaccinum nasal drops are indicated for the prophylaxis and treatment of RURTI in adults and children from 6 months old and suspension for injections are indicated for prophylactic and therapeutic use or adjunctive treatment in case of long-lasting, chronic and recurrent RTI in adults and children from 2 years of age.
Croatian: Kapi za nos Polyvaccinum indicirane su za profilaksu i liječenje ponovljene infekcije gornjeg dišnog sustava u odraslih osoba i djece u dobi od šest ili više mjeseci, a otopina za injekcije Polyvaccinum indicirana je za profilaktičku i terapijsku primjenu ili pomoćno liječenje u slučaju dugotrajne, kronične i ponavljajuće infekcije dišnog sustava u odraslih osoba i djece u dobi od dvije ili više godina.
English: No study evaluating the effect of Ismigen in the treatment of RTIs was identified.
Croatian: Nije utvrđeno nijedno ispitivanje kojim se ocjenjuje učinak lijeka Ismigen u liječenju infekcija dišnog sustava.
English: A small doubleblind placebo-controlled RCT and some supportive studies with methodological limitations provide some evidence of efficacy of Ismigen in the prophylaxis of URTIs in adults.
Croatian: Malo dvostruko slijepo randomizirano placebom kontrolirano kliničko ispitivanje i neka potporna ispitivanja s metodološkim ograničenjima pružaju neke dokaze o djelotvornosti lijeka Ismigen u profilaksi infekcija gornjeg dišnog sustava u odraslih osoba.
English: Buccalin is indicated for the prophylaxis of RRTI in adults and of bacterial RURTI in children older than 6 months or for the prophylaxis of bacterial RTI without age limits.
Croatian: Buccalin je indiciran za profilaksu ponovljene infekcije dišnog sustava u odraslih i bakterijske ponovljene infekcije gornjeg dišnog sustava u djece starije od šest mjeseci ili za profilaksu bakterijske infekcije dišnog sustava bez dobnih ograničenja.
English: Limited data provides some evidence of efficacy in the prophylaxis of recurrent respiratory infections to different extent depending on products and on age groups.
Croatian: Ograničeni podatci pružaju određene dokaze o djelotvornosti u profilaksi ponavljanih infekcija dišnog sustava u različitom opsegu, ovisno o lijekovima i dobnim skupinama.
English: The SAG AI was of the view that extrapolation of clinical effects of the medicinal products in prophylaxis of URTI to LRTI and vice versa is not scientifically justified because upper and lower RTI represent different disease entities.
Croatian: SAG AI smatrao je da ekstrapolacija kliničkih učinaka lijekova u profilaksi infekcije gornjeg dišnog sustava na infekciju donjeg dišnog sustava i obrnuto nije znanstveno opravdana jer infekcije gornjeg i donjeg dišnog sustava predstavljaju različite pojave bolesti.
English: Limited data provides some evidence of efficacy in the prophylaxis of respiratory infections to different extents depending on products and on age groups.
Croatian: Ograničeni podatci pružaju određene dokaze o djelotvornosti u profilaksi infekcija dišnog sustava u različitom opsegu, ovisno o lijekovima i dobnim skupinama.
English: Respivax is indicated for the prophylaxis and treatment of chronic and recurrent RTI in adults and children from 3 years of age.
Croatian: Respivax je indiciran za profilaksu i liječenje kroničnih i ponovljenih infekcija dišnog sustava u odraslih i djece u dobi od tri ili više godina.
English: Ismigen is indicated in for the prophylaxis of RRTI in adults and in some MS for the treatment of acute, subacute recurrent or chronic RTI as well as in one MS in children from 3 years of age.
Croatian: Ismigen je indiciran za profilaksu ponovljene infekcije dišnog sustava u odraslih osoba, a u nekim državama članicama i za liječenje akutne, subakutne ponovljene ili kronične infekcije dišnog sustava, te u jednoj državi članici i za liječenje djece u dobi od tri ili više godina.
English: Lantigen B is indicated for the prophylaxis and treatment of RURTI or bacterial URTI in adults and children, as prophylaxis of RRTI in adults and URTIs in children or for the prevention of RRTI in adults and children from 3 years of age.
Croatian: Lantigen B indiciran je za profilaksu i liječenje ponovljene infekcije gornjeg dišnog sustava ili bakterijske infekcije gornjeg dišnog sustava u odraslih i djece, za profilaksu ponovljene infekcije dišnog sustava u odraslih i infekcijâ gornjeg dišnog sustava u djece ili za sprječavanje ponovljene infekcije dišnog sustava u odraslih i djece u dobi od tri ili više godina.
English: In one MS, the paediatric indication is restricted to recurrent upper RTI (RURTI).
Croatian: U jednoj je državi članici pedijatrijska indikacija ograničena na ponovljenu infekciju gornjeg dišnog sustava.
English: Luivac is indicated for the prophylaxis of recurrent respiratory tract infections (RRTI) in adults and children from 4 years of age.
Croatian: Luivac je indiciran za profilaksu ponovljenih infekcija dišnog sustava u odraslih i djece u dobi od četiri ili više godina.
English: A meta-analysis reporting a favourable effect had also a number of limitations and the MAH plans to revise it. No study evaluating the effect of Lantigen B in the treatment of RTIs was identified.
Croatian: Metaanaliza u kojoj se izvješćuje o povoljnom učinku također je imala niz ograničenja, a nositelj odobrenja za stavljanje u promet planira je revidirati.
English: The prototypic URTI is the common cold. URTI occur commonly in both children and adults and is a major cause of mild morbidity.
Croatian: Infekcija gornjeg dišnog sustava često se javlja i kod djece i odraslih i glavni je uzrok blagog obolijevanja.
English: Both medicines were given by infusion, for between 14 and 42 days.
Croatian: Oba su lijeka primijenjena infuzijom u razdobljima od 14 do 42 dana.
English: The full EPAR for Ecalta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ecalta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was the number of patients who had responded to treatment at the end of the treatment course.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su odgovorili na liječenje po završetku terapije.
English: The duration of treatment depends on how the patient responds.
Croatian: Trajanje liječenja ovisi o odgovoru bolesnika.
English: Ecalta is available with or without a solvent.
Croatian: Ecalta je dostupan s ili bez otapala.
English: Ecalta is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two.
Croatian: Ecalta se primjenjuje u početnoj dozi od 200 mg 1. dana, nakon čega od 2. dana slijedi 100 mg svakog dana.
English: In the analysis of patients with neutropenia, around 57% of patients (26 out of 46) had responded to treatment.
Croatian: Analizom bolesnika s neutropenijom utvrđeno je da je otprilike 57% bolesnika (26 od 46) odgovorilo na liječenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ecalta on 20 September 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ecalta na snazi u Europskoj uniji od 20. rujna 2007.
English: At the end of the treatment course, 76% of the patients receiving Ecalta had responded to treatment (96 out of 127), compared with 60% of the patients receiving fluconazole (71 out of 118).
Croatian: Po završetku terapije, 76% bolesnika koji su primali lijek Ecalta odgovorilo je na liječenje (96 od 127), u usporedbi sa 60% bolesnika koji su primali flukonazol (71 od 118).
English: Other information about Ecalta
Croatian: Ostale informacije o lijeku Ecalta
English: A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient.
Croatian: Odgovor je bio definiran kao značajno ili potpuno poboljšanje simptoma, bez potrebe za daljnjom terapijom protiv gljivica i bez tragova gljivice Candida u uzorku uzetom kod bolesnika.
English: Ecalta should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions.
Croatian: Ecalta se primjenjuje samo infuzijom maksimalnom brzinom od 1,1 mg po minuti kako bi se izbjegle nuspojave, što odgovara trajanju od otprilike tri sata za početnu infuziju, te jedan i pol sat za sve kasnije infuzije.
English: What measures are being taken to ensure the safe and effective use of Ecalta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ecalta?
English: It works by interfering with the production of a component of the fungal cell wall called 1,3 β D glucan, which is necessary for the fungus to continue living and growing.
Croatian: Djeluje tako da suzbija proizvodnju komponente gljivične stanične stjenke naziva 1,3-β-D glukan, koja je neophodna za život i rast gljivice.
English: An analysis of other studies evaluated the effects Ecalta in 46 patients with neutropenia.
Croatian: Analiza drugih ispitivanja ocijenila je djelovanje lijeka Ecalta u 46 bolesnika s neutropenijom.
English: Fungal cells treated with Ecalta have incomplete or defective cell walls, making them fragile and unable to grow.
Croatian: Gljivične stanice liječenje lijekom Ecalta imaju nepotpune ili oštećene stanične stjenke, što ih čini osjetljivima i nesposobnima za rast.
English: This is a summary of the European public assessment report (EPAR) for Ecalta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) lijeka Ecalta.
English: It is not intended to provide practical advice on how to use Ecalta.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Ecalta.
English: The Committee recommended that Ecalta be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ecalta.
English: Treatment with Ecalta should be started by a doctor who has experience in the management of invasive fungal infections.
Croatian: Liječenje lijekom Ecalta treba započeti liječnik s iskustvom u liječenju invazivnih gljivičnih infekcija.
English: A risk management plan has been developed to ensure that Ecalta is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ecalta.
English: Why has Ecalta been approved?
Croatian: Zašto je Ecalta odobren?
English: What is the risk associated with Ecalta?
Croatian: Koji su rizici povezani s lijekom Ecalta?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ecalta, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Ecalta nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The most common side effects with Ecalta (seen in more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and hypokalaemia (low blood potassium levels).
Croatian: Najčešće nuspojave lijeka Ecalta (mogu se javiti u više od 1 na 10 osoba) su proljev, mučnina (osjećaj slabosti) i hipokalemija (niske razine natrija u krvi).
English: Ecalta was compared with fluconazole (another antifungal medicine).
Croatian: Lijek Ecalta uspoređen je s flukonazolom (drugim antifungicidom).
English: Ecalta must not be used in people who are hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class.
Croatian: Ecalta se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na anidulafungin ili na bilo koju drugu pomoćnu tvar, odnosno bilo koji lijek iz klase ehinokandina.
English: However, the Committee noted that Ecalta has been studied mainly in patients with candidaemia (Candida in the blood) and only in a limited number of patients with neutropenia (low white blood cell counts) or deep tissue infections or abscesses.
Croatian: No, Odbor je napomenuo da je Ecalta ispitivan uglavnom u bolesnika oboljelih od kandidemije (Candida u krvi) te samo u ograničenom broju bolesnika s neutropenijom (mali broj bijelih krvnih stanica) ili s infekcijama dubokog tkiva, odnosno s apscesima.
English: Ecalta is a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Ecalta je prašak za pripremu otopine za infuziju (drip) u venu.
English: It contains the active substance anidulafungin.
Croatian: Sadrži djelatnu tvar anidulafungin.
English: What is Ecalta?
Croatian: Što je Ecalta?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom treatment should continue for at least two weeks after the last day that fungus is found in the patient's blood.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Ecalta was more effective than fluconazole in treating invasive candidiasis in non-neutropenic patients.
Croatian: Ecalta je bio djelotvorniji od lijeka flukonazol u liječenju invazivne kandidijaze u bolesnika koji nisu imali neutropeniju.
English: Ecalta has been studied in one main study involving 261 patients with invasive candidiasis and who did not have neutropenia (low white blood cell counts).
Croatian: Lijek Ecalta je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 261 bolesnika s invazivnom kandidijazom i bolesnicima koji nisu imali neutropeniju (mali broj bijelih krvnih stanica).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta's benefits are greater than its risks for the treatment of invasive candidiasis in adult patients.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka Ecalta nadmašuju s njim povezane rizike za liječenje invazivne kandidijaze u odraslih bolesnika.
English: For more information about treatment with Ecalta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ecalta pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The list of fungi against which Ecalta is active can be found in the summary of product characteristics (also part of the EPAR).
Croatian: Popis gljivica protiv kojih je lijek Ecalta djelotvoran dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: For practical information about using Ecalta, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Ecalta pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: The active substance in Ecalta, anidulafungin, is an antifungal medicine, which belongs to the group ‘echinocandins'.
Croatian: Djelatna tvar lijeka Ecalta, anidulafungin, jest antifungicid koji se ubraja u klasu „ehinokandina“.
English: Ecalta is used to treat adult patients with invasive candidiasis (a fungal infection caused by a yeast called Candida).
Croatian: Ecalta se koristi za liječenje odraslih bolesnika s invazivnom kandidijazom (gljivičnom infekcijom koju uzrokuje kvasac naziva Candida). „Invazivno“ znači da se gljivica proširila u krvotok.
English: What is Ecalta used for?
Croatian: Za što se Ecalta koristi?
English: What benefit has Ecalta shown during the studies?
Croatian: Koje su koristi lijeka Ecalta utvrđene u ispitivanjima?
English: How does Ecalta work?
Croatian: Kako djeluje Ecalta?
English: How is Ecalta used?
Croatian: Kako se Ecalta koristi?
English: For the full list of all side effects reported with Ecalta, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ecalta potražite u uputi o lijeku.
English: How has Ecalta been studied?
Croatian: Kako je Ecalta ispitivan?
English: ATCvet code: QI02AA.
Croatian: ATCvet kod: QI02AA.
English: November 2015
Croatian: Studeni 2015
English: These measures should help to protect the environment.
Croatian: Te mjere trebaju pomoći pomaći u zaštiti okoliša.
English: Can be used from 2 months of pregnancy and onwards.
Croatian: Može se koristiti od 2. mjeseca graviditeta na dalje.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/02/2015
Croatian: Datum prvog odobrenja: 06/02/2015
English: Off-white or pink liquid.
Croatian: Bjelkasta ili ružičasta tekućina.
English: At next commercial batch manufacture
Croatian: Pri sljedećoj komercijalnoj proizvodnji serije
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Croatian: b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
English: Continue to develop a test to quantify saponin in the finished product and provide regular updates on results
Croatian: Nastaviti razvijati test za određivanje količine saponina u gotovom proizvodu i redovito obavještavati o rezultatima
English: Provide stability results for batch 19512 at the end of shelf life
Croatian: Osigurati rezultate stabilnosti za seriju 19512 na kraju roka valjanosti
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije oznake “EXP”.
English: Aluminium hydroxide Saponin
Croatian: Aluminijev hidroksid Saponin
English: * Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep.
Croatian: * Ispod razine detekcije pomoću potvrdne RT-PCR metode pri 3,6 log10 RNA kopija/ml plazme za goveda i pri 3,4 log10 RNA kopija/ml plazme za ovce.
English: Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 1 godina.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride Water for injections
Croatian: Kalijev klorid Kalijev dihidrogen fosfat Dinatrijev fosfat dihidrat Natrijev klorid Voda za injekcije
English: Inactivated Schmallenberg virus, strain BH80/11-4
Croatian: Inaktivirani virus Schmallenberg, soj BH80/11-4
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Croatian: EXP {mjesec/godina} Jednom otvoren, odmah upotrijebiti.