FrancophonIA/ELRC3.0 huggingface dataset:
English: Whilst the matter is being further reviewed, the PRAC recommended as a provisional measure an update of the posology and warnings to take due account that treatment should not be initiated in patients with systemic infections, patients should be monitored for respiratory symptoms and be administered Pneumocystis jirovecii pneumonia prophylaxis.
Croatian: Iako se to pitanje dodatno ponovno ocjenjuje, PRAC je kao privremenu mjeru preporučio izmjene doziranja i upozorenja da se liječenje ne smije inicirati u bolesnika sa sistemskim infekcijama, da je potrebno pratiti respiratorne simptome bolesnika i propisivati preventivnu terapiju za upalu pluća uzrokovanu gljivicom Pneumocystis jirovecii.
English: The PRAC considered the very limited new safety data from three studies (GS-US-312-0123, GSUS-313-0124, GS-US-313-0125), now terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL).
Croatian: PRAC je razmotrio vrlo ograničene nove podatke o sigurnosti iz triju ispitivanja (GS-US-312-0123, GSUS-313-0124, GS-US-313-0125), koja su sada prekinuta, a u kojima se ocjenjivalo dodavanje idelalisiba standardnim terapijama u prvoj liniji za CLL i za ponovnu pojavu indolentnog ne-Hodgkinovog limfoma (iNHL)/malog limfocitnog limfoma (SLL).
English: • The PRAC reviewed the very limited and preliminary data provided by the marketing authorisation holder on the interim results of study GS-US-312-0123, GS-US-313-0124, GS-US-313-0125 that suggested an increased risk of death and serious infection with idelalisib.
Croatian: • PRAC je ponovno ocijenio vrlo ograničene i preliminarne podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet o privremenim rezultatima ispitivanja GS-US-312-0123, GS-US-313-0124 i GS-US-313-0125 koja su ukazivala na povećani rizik od smrti i teških infekcija kod primjene idelalisiba.
English: Although the potential impact of these new safety findings in the current authorised indications is presently unknown, the PRAC recommended provisional amendments of the indication of idelalisib and considered that as a precautionary measure, idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation.
Croatian: Iako mogući utjecaj ovih novih saznanja u pogledu sigurnosti u trenutačno odobrenim indikacijama trenutačno nije poznat, PRAC je preporučio privremene izmjene indikacija za idelalisib te smatra da se, u vidu privremene mjere, idelalisib ne bi smio inicirati kao terapija prve linije u bolesnika s CLL-om s delecijom 17p ili mutacijom TP53.
English: Zydelig (Idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Croatian: Zydelig (idelalisib) centralno je odobren lijek koji je trenutno indiciran u kombinaciji s rituksimabom za liječenje odraslih bolesnika s kroničnom limfocitnom leukemijom (CLL) koji su prethodno primili najmanje jednu terapiju ili kao terapija prve linije u slučaju prisutnosti delecije 17p ili mutacije TP53 u bolesnika neprikladnih za kemo-imunoterapiju.
English: Further, if continuing with therapy, new risk minimisation (see below) should be implemented.
Croatian: U slučaju nastavka terapije, potrebno je provesti nove mjere svođenja rizika na najmanju moguću mjeru (vidi u nastavku).
English: On 10 March 2016, the European Commission was informed that an increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups had been observed in three clinical trials by the Independent Safety Data Monitoring group.
Croatian: Europska je komisija 10. ožujka 2016. obaviještena o tome da je neovisna skupina za praćenje podataka o sigurnosti u trima kliničkim ispitivanjima uočila povećani rizik od smrti i veću učestalost ozbiljnih nuspojava među subjektima koji primaju idelalisib u usporedbi s kontrolnim skupinama.
English: The PRAC noted that in study -0123, idelalisib was administered in combination with bendamustine and rituximab (which is not an authorised combination) and CLL patients were previously untreated, which is not consistent with the current CLL indication.
Croatian: PRAC je uočio da je u ispitivanju -0123 idelalisib primjenjivan u kombinaciji s bendamustinom i rituksimabom (što nije odobrena kombinacija) te da bolesnici s CLL-om prethodno nisu primali terapiju, što nije u skladu s postojećim indikacijama za CLL.
English: • The PRAC noted that the use of idelalisib in studies -0123, -0124 and -0125 was in different conditions than those currently authorised, and at earlier stages of the diseases.
Croatian: • PRAC je uočio da je u ispitivanjima -0123, -0124 i -0125 idelalisib primjenjivan u uvjetima koji se razlikuju od onih koji su trenutačno odobreni te u ranijim fazama bolesti.
English: As a temporary measure, the PRAC recommended that idelalisib should not be initiated as a first line treatment in CLL patients with 17p deletion or TP53 mutation.
Croatian: Kao privremenu mjeru, PRAC je preporučio da se idelalisib ne inicira kao terapija prve linije u bolesnika s CLL-om s delecijom 17p ili mutacijom TP53.
English: The PRAC took into account the data submitted by the marketing authorisation holder (MAH).
Croatian: PRAC je uzeo u obzir podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet.
English: A table to guide physicians was proposed for the posology section.
Croatian: Za odjeljak o doziranju predložena je tablica kao pomoć liječnicima.
English: Annex IV Conditions of the marketing authorisations
Croatian: Dodatak IV Uvjeti odobrenja
English: It shall thus be set up in advance of placing the product on the market.
Croatian: Tako će biti određeno prije stavljanja lijeka na tržište.
English: This RMP shall follow the EU RMP template and shall include the measures to assess the effectiveness of the risk minimisation.
Croatian: Ovaj RMP slijedit će predložak EU RMP i uključit će mjere za procjenu djelotvornosti minimizacije rizika.
English: The registry's protocol shall be submitted to the national competent authorities within 2 months of Commission Decision.
Croatian: Protokol postupka registra bit će podnesen nacionalnim nadležnim tijelima unutar 2 mjeseca od odluke Komisije.
English: Marketing authorisation holders of aprotinin containing medicinal products shall submit to the national competent authorities, further to the issuing of the Commission Decision and prior to relaunch of the medicinal product to the European market, an update of the risk management plan (RMP) referring to the agreed products' safety concerns as described in the assessment report of the referral procedure and their risk minimisation which includes a direct healthcare professional communication.
Croatian: Nositelji odobrenja za lijekove koji sadrže aprotinin podnijet će nacionalnim nadležnim tijelima, nakon odluke Komisije a prije ponovnog puštanja lijeka na europsko tržište, ažurirani plan upravljanja rizikom (RMP) koji se odnosi na usuglašena sigurnosna pitanja u vezi s upotrebom lijeka kako je opisano u izvješću postupka procjene i minimizacije njihova rizika koje uključuje izravno priopćenje zdravstvenim djelatnicima.
English: A restricted distribution of aprotinin with the above mentioned registry, with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry.
Croatian: Ograničena distribucija aprotinina s gore navedenim registrom, tako da je aprotinin dostupan samo centrima koja provode kirurške zahvate s ugradnjom kardiopulmonalnih premosnica i koji se slažu da sudjeluju u registru.
English: Updates on the registry will be submitted to national competent authorities with periodic safety update reports (PSURs).
Croatian: Obnove/ažuriranja registra podnosit će se nacionalnim nadležnim tijelima uz periodička sigurnosna izvješća (PSUR).
English: Marketing authorisation holders shall conduct a registry, in order to monitor the pattern of use of aprotinin.
Croatian: Nositelji odobrenja vodit će registar kako bi se nadzirao obrazac upotrebe aprotinina.
English: National Competent Authorities shall ensure that the following conditions are fulfilled by the MAHs of aprotinin containing medicinal products:
Croatian: Nacionalna nadležna tijela osigurat će da nositelji odobrenja za stavljanje lijeka u promet ispune sljedeće uvjete za lijekove koji sadrže aprotinin:
English: The registry shall record utilisation information on patients at cardiac surgery centres exposed to aprotinin in participating countries.
Croatian: Registar će bilježiti podatke o korisnosti u bolesnika izloženih aprotininu u centrima za kardiokirurgiju zemalja sudionica.
English: The MAH shall take due account of the draft protocol and comments received during assessment.
Croatian: Nositelji odobrenja vodit će računa o nacrtu protokola i napomenama primljenim tijekom procjene.
English: None.
Croatian: Nikakvih.
English: This will help to protect against the disease.
Croatian: To pomaže pri zaštiti od bolesti.
English: This summary was last updated in February 2016.
Croatian: Sažetak je posljednji put ažuriran u veljači 2016.
English: In the future, if the animals are exposed to the parasite, the immune system will be able to respond more quickly.
Croatian: Ako životinje u budućnosti budu izložene tom parazitu, imunosni sustav moći će brže reagirati.
English: Protection starts four weeks after vaccination and lasts one year.
Croatian: nastupa četiri tjedna nakon cijepljenja i traje godinu dana.
English: The full EPAR for Letifend can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Letifend nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Letifend is a vaccine.
Croatian: Letifend je cjepivo.
English: Only non-infected animals should be vaccinated.
Croatian: Cijepe se samo neinficirane životinje.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Cjepiva djeluju „učeći” imunosni sustav (prirodnu obranu tijela) kako da se obrani od bolesti.
English: Dogs that have been infected may show no signs of infection, but some have active disease with symptoms such as fever, hair and weight loss, and skin sores.
Croatian: Zaraženi psi ne moraju pokazivati znakove infekcije, no kod nekih je bolest aktivna sa simptomima vrućice, gubitka dlake i težine i nadražene kože.
English: What is Letifend and what is it used for?
Croatian: Što je Letifend i za što se koristi?
English: Why is Letifend approved?
Croatian: Zašto je Letifend odobren?
English: In a field study in France and Spain 275 dogs were vaccinated with Letifend and 274 dogs received placebo (a dummy vaccination).
Croatian: Tijekom ispitivanja na terenu u Francuskoj i Španjolskoj 275 pasa cijepljeno je Letifendom, a 274 psa primila su placebo (lažno cjepivo).
English: The European Commission granted a marketing authorisation valid throughout the EU for Letifend on 20.04.2016.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Letifend na snazi u Europskoj uniji od 20. travnja 2016.
English: Over a two year period there were 8 confirmed cases of leishmaniasis in the vaccinated group compared with 19 cases in the placebo group, showing that Letifend was effective in reducing the occurrence of the disease.
Croatian: Tijekom razdoblja od dvije godine potvrđeno je 8 slučajeva lišmanijaze u cijepljenoj skupini, nasuprot 19 slučajeva u skupini koja je primila placebo, što je pokazalo da je Letifend bio učinkovit u smanjivanju oboljenja.
English: The most common side effect with Letifend (which may affect more than 1 in 10 animals) is scratching at the injection site which resolves within four hours.
Croatian: Najčešća je nuspojava VMP-a Letifend (može se javiti u više od 1 na 10 životinja) češanje na mjestu injekcije, koje prestaje u roku četiri sata.
English: The parasite is widespread in countries bordering the Mediterranean Sea and is transmitted by the bites of sand flies.
Croatian: Taj je parazit rasprostranjen u zemljama uz Sredozemno more, a prenosi se ugrizima papatača.
English: The vaccine is given to dogs from 6 months of age as a single injection under the skin.
Croatian: Cjepivo se daje psima starijima od 6 mjeseci tako da im se ubrizga injekcija pod kožu.
English: It is not intended to provide practical advice on how to use Letifend.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Letifend.
English: This is a summary of the European public assessment report (EPAR) for Letifend.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarskomedicinskom proizvodu Letifend.
English: A ‘booster' injection should be given every year to maintain the vaccine's effect.
Croatian: Kako bi se održalo djelovanje cjepiva, svake godine treba primijeniti jednu „booster” injekciju.
English: Letifend is available as a freeze-dried powder (lyophilisate) and solvent that are made up into a solution for injection, and can only be obtained with a prescription.
Croatian: Letifend je dostupan kao smrzavanjem osušen prašak (liofilizat) i otapalo za pripremu otopine za injekciju i izdaje se samo na recept.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Letifend'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 Letifend nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: What are the risks associated with Letifend?
Croatian: Koji su rizici povezani s VMP-om Letifend?
English: When Letifend is given to dogs the immune system recognises the Leishmania protein as ‘foreign' and makes defences against it.
Croatian: Kada se Letifend daje psima, imunosni sustav prepoznaje bjelančevinu parazita Leishmania kao „strano tijelo” i stvara obrambeni mehanizam protiv nje.
English: Letifend is a veterinary vaccine used in dogs to protect them against leishmaniasis due to the parasite Leishmania infantum.
Croatian: Letifend je veterinarsko cjepivo koje se koristi kod pasa da bi ih se zaštitilo od lišmanijaze uzrokovane parazitom Leishmania infantum.
English: Letifend contains the active substance protein Q, which is made of different fragments of proteins from Leishmania infantum.
Croatian: Letifend sadrži djelatnu tvar bjelančevinu Q, koja je sastavljena od različitih dijelova bjelančevina parazita Leishmania infantum.
English: How does Letifend work?
Croatian: Kako djeluje Letifend?
English: Infected dogs can help spread the disease to humans.
Croatian: Bolest se s inficiranih pasa može prenijeti na ljude.
English: What benefits of Letifend have been shown in studies?
Croatian: Koje su koristi VMP-a Letifend utvrđene u ispitivanjima?
English: The dogs were exposed to natural infection with Leishmania infantum.
Croatian: Psi su bili prirodno izloženi uzročniku Leishmania infantum.
English: For practical information about using Letifend, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Letifend vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Before vaccination, dogs should be tested for Leishmania infection.
Croatian: Prije cijepljenja pse treba testirati na infekciju parazitom Leishmania.
English: How is Letifend used?
Croatian: Kako se Letifend koristi?
English: For more information about treatment with Letifend, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Letifend vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Other information about Letifend?
Croatian: Ostale informacije o VMP-u Letifend
English: Letifend canine leishmaniasis vaccine (recombinant protein)
Croatian: Letifend cjepivo za pse protiv lišmanijaze (rekombinirana bjelančevina)
English: vaccinated dogs since the vaccine does not prevent Leishmania infection.
Croatian: Kod cijepljenih pasa treba primijeniti mjere za smanjivanje izloženosti papatačima jer cjepivo ne sprječava infekciju parazitom Leishmania.
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Croatian: OBLIK I SADRŽAJ 28 tableta
English: 84 tablets
Croatian: 84 tablete
English: 30 tablets
Croatian: 30 tablete
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži
English: Patients with controlled bleedingb,c, d
Croatian: Bolesnice s kontroliranim krvarenjemb,c, d
English: Frequencies are defined as 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) and not known (cannot be estimated from available data).
Croatian: (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Study 3a
Croatian: 3a
English: Patients in amenorrheab,c
Croatian: Bolesnice s amenorejomb,c
English: EU/1/18/1309/001 28 tablets EU/1/18/1309/002 84 tablets EU/1/18/1309/003 30 tablets EU/1/18/1309/004 28 tablets EU/1/18/1309/005 84 tablets
Croatian: EU/1/18/1309/001 28 tablete EU/1/18/1309/002 84 tablete EU/1/18/1309/003 30 tablete EU/1/18/1309/004 28 tablete EU/1/18/1309/005 84 tablete
English: Gedeon Richter (listed in section 6).
Croatian: Richter (naveden u dijelu 6).
English: 17, rue de Pontoise F-95520 Osny France
Croatian: 17, Rue de Pontoise F-95520 Osny Francuska
English: Gedeon Richter Plc, 1103 Budapest
Croatian: Gedeon Richter Plc. 1103 Budimpešta
English: Treatment whilst pregnant might affect your pregnancy (it is not known if Ulipristal Acetate Gedeon Richter might harm your baby or whether can cause miscarriage).
Croatian: Liječenje za vrijeme trudnoće može utjecati na Vašu trudnoću (nije poznato može li Ulipristal Acetate Gedeon Richter naškoditi Vašem djetetu ili uzrokovati pobačaj).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Ulipristal Acetate Gedeon Richter is used in adult women (over 18 years of age) before they reach the menopause.
Croatian: Ulipristal Acetate Gedeon Richter se koristi u odraslih žena (starijih od 18 godina) prije nego uđu u menopauzu.
English: Headache Mild or moderate severity headache was reported in 5.8% of patients.
Croatian: Glavobolja blage ili umjerene jačine prijavljena je u 5,8% bolesnica.
English: The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).
Croatian: Opažena učestalost odgovara podacima za kontrolne skupine i prevalenciji objavljenoj u literaturi za žene ove dobne skupine (prosjek od 40 godina) sa simptomima predmenopauze.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ulipristal Acetate Gedeon Richter in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Ulipristal Acetate Gedeon Richter u svim podskupinama pedijatrijske populacije s leiomiomima uterusa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Available toxicological data in animals have shown excretion of ulipristal acetate in milk (for details see section 5.3).
Croatian: Dojenje Dostupni toksikološki podaci u životinja pokazuju da se ulipristalacetat izlučuje u mlijeko (za detalje vidjeti dio 5.3).
English: For further treatment courses, your liver will be checked once before each new treatment course and if you experience any of the symptoms described below.
Croatian: Za daljnje cikluse liječenja Vaša jetra provjeravat će se jednom prije svakog novog ciklusa liječenja i ako osjetite bilo koji od simptoma navedenih u nastavku.
English: respectively, p=0.027).
Croatian: 10 mg, p=0,027).
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: In study 3, treatment efficacy has been shown over > 18 months of repeated intermittent treatment (4 courses of 10 mg once daily), 89.7% of patients were in amenorrhea at the end of the treatment course 4.
Croatian: U ispitivanju 3 djelotvornost liječenja dokazana je nakon > 18 mjeseci ponovljenog intermitentnog liječenja (4 ciklusa od 10 mg jednom dnevno), u 89,7% bolesnica postignuta je amenoreja na kraju 4.
English: Treatment with Ulipristal Acetate Gedeon Richter usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period') within the first 10 days of treatment.
Croatian: Liječenje lijekom Ulipristal Acetate Gedeon Richter obično uzrokuje znatno smanjenje ili čak i prestanak menstrualnog krvarenja („mjesečnice“) unutar prvih 10 dana liječenja.
English: • key effects of Ulipristal Acetate Gedeon Richter on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Croatian: • Ključne učinke lijeka Ulipristal Acetate Gedeon Richter na promjene endometrija povezane s modulatorom progesteronskih receptora (PAEC) te kako ih razlikovati od učinaka neoponiranog estrogena.
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc and magnesium stearate.
Croatian: Drugi sastojci su mikrokristalična celuloza, manitol, umrežena karmelozanatrij, talk i magnezijev stearat.
English: What Ulipristal Acetate Gedeon Richter looks like and contents of the pack Ulipristal Acetate Gedeon Richter is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Croatian: Kako Ulipristal Acetate Gedeon Richter izgleda i sadržaj pakiranja Ulipristal Acetate Gedeon Richter je bijela do bjelkasta, okrugla bikonveksna tableta promjera 7 mm, s utisnutim znakom “ES5” na jednoj strani.
English: The MAH shall ensure that, at launch and thereafter, all prescribers of Ulipristal Acetate Gedeon Richter and pathologists who review samples from Ulipristal Acetate Gedeon Richter-treated patients, as well as patients treated with Ulipristal Acetate Gedeon Richter, are provided with educational material.
Croatian: MAH će osigurati da, u trenutku puštanja lijeka u promet i nakon toga, svi propisivači lijeka Ulipristal Acetate Gedeon Richter i patolozi koji analiziraju uzorke uzete od bolesnica liječenih lijekom Ulipristal Acetate Gedeon Richter, kao i bolesnice liječene lijekom Ulipristal Acetate Gedeon Richter, imaju dostupan edukacijski materijal.