FrancophonIA/ELRC3.0 huggingface dataset:
English: Another study included 146 patients, among which 37 patients had mucormycosis and were treated with Cresemba; in patients with mucormycosis the mortality rate after 84 days was 43%, which is similar to rates seen in the published literature for standard treatments with amphotericin-B.
Croatian: Drugo glavno ispitivanje uključilo je 146 bolesnika s invanzivnom aspergilozom ili mukormikozom, od kojih je 37 bolesnika imalo mukormikozu i bilo je liječeno lijekom Cresemba; u bolesnika s mukormikozom stopa smrtnosti nakon 84 dana iznosila je 43 %.
English: Cresemba contains the active substance isavuconazole.
Croatian: Cresemba sadrži djelatnu tvar izavukonazol.
English: For the full list of all side effects reported with Cresemba, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Cresemba potražite u uputi o lijeku.
English: How does Cresemba work?
Croatian: Kako djeluje Cresemba?
English: The marketing authorisation holder of SoliCol D3 shall provide evidence that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC laying down the principles and guidelines of Good Manufacturing Practice (GMP) as provided for in Article 8(3) of Directive 2001/83/EC.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet za lijek SoliCol D3 pružit će dokaz da je proizvodni postupak u skladu s Direktivom Komisije 2003/94/EZ o utvrđivanju načela i smjernica dobre proizvođačke prakse kako je navedeno u članku 8. stavku 3. Direktive 2001/83/EZ.
English: For the suspension of SoliCol D3 to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holder(s):
Croatian: Kako bi se ukinula privremena obustava lijeka SoliCol D3, nadležna će tijela osigurati da je nositelj odobrenja za stavljanje lijeka u promet ispunio sljedeće uvjete:
English: Conditions for lifting the suspension of the marketing authorisation(s)
Croatian: Uvjeti za ukidanje privremene obustave odobrenja za stavljanje lijeka u promet
English: The full EPAR for Erelzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Erelzi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In children, the dose will depend on body weight.
Croatian: U djece doza ovisi o djetetovoj tjelesnoj težini.
English: In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week.
Croatian: Uobičajena preporučena doza za odrasle je 25 mg dvaput tjedno ili 50 mg jednom tjedno.
English: Over 70% of those given Erelzi (186 of 264 patients) and roughly 72% of those given Enbrel (191 of 267) had at least 75% reduction in their symptom score after 12 weeks of treatment, which was the main measure of effectiveness.
Croatian: U više od 70 % osoba koje su primale Erelzi (186 od 264 bolesnika) i otprilike 72 % osoba koje su primale Enbrel (191 od 267 bolesnika), nakon 12 tjedana liječenja rezultat mjerenja simptoma bio je smanjenje od barem 75 %, što je bila glavna mjera djelotvornosti.
English: This means that Erelzi is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, Erelzi je sličan biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: Erelzi is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough or cannot be used.
Croatian: Erelzi se uglavnom primjenjuje kada su navedene bolesti teške ili umjereno teške ili kada druga liječenja nisu dovoljno dobro djelovala ili nisu prikladna.
English: What is Erelzi and what is it used for?
Croatian: Što je Erelzi i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Erelzi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Erelzi?
English: The educational materials also include a reminder that Erelzi is not for use in children and adolescents who weigh less than 62.5 kg.
Croatian: Ti edukacijski materijali uključuju i podsjetnik na to da lijek Erelzi nije namijenjen djeci i adolescentima tjelesne težine manje od 62,5 kg.
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Croatian: Blokiranjem TNF-a etanercept smanjuje upalu i druge simptome bolesti.
English: Erelzi must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with active infections.
Croatian: Erelzi se ne smije primjenjivati u bolesnika u kojih postoji rizik od sepse (kada bakterije i toksini cirkuliraju u krvi i počnu oštećivati organe) ili u bolesnika s aktivnim infekcijama.
English: Erelzi is an anti-inflammatory medicine for treating the following diseases:
Croatian: Erelzi je protuupalni lijek za liječenje sljedećih bolesti:
English: The most common side effects with etanercept (seen in more than 1 patient in 10) are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Croatian: Najčešće nuspojave etanercepta (uočene u više od 1 na 10 bolesnika) jesu reakcije na mjestu ubrizgavanja injekcije (uključujući krvarenje, crvenilo, svrbež, bol i oticanje) i infekcije (uključujući prehlade te infekcije pluća, mokraćnog mjehura i kože).
English: The Committee recommended that Erelzi be given marketing authorisation.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Erelzi u promet.
English: This is a summary of the European public assessment report (EPAR) for Erelzi.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni lijeka (EPAR) Erelzi.
English: The company that markets Erelzi will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor.
Croatian: Tvrtka koja stavlja na tržište lijek Erelzi dostavit će edukacijski materijal za liječnike za koje se očekuje da će propisivati lijek kako bi podučili bolesnike o ispravnoj upotrebi napunjene brizgalice i posebnu karticu upozorenja za bolesnike kako bi prepoznali ozbiljne nuspojave i znali kada trebaju hitno potražiti pomoć svog liječnika.
English: Patients developing a serious infection should stop Erelzi treatment.
Croatian: Bolesnici koji razviju ozbiljne infekcije moraju prestati primjenjivati Erelzi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Erelzi has been shown to have a comparable quality, safety and effectiveness to Enbrel.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Erelzi dokazao usporedivu kakvoću, sigurnost i učinkovitost kao i Enbrel.
English: Because Erelzi is a biosimilar medicine, the studies on effectiveness and safety of etanercept carried out with Enbrel do not all need to be repeated for Erelzi.
Croatian: Budući da je Erelzi biosličan lijek, ne treba sva ispitivanja učinkovitosti i sigurnosti etanercepta, provedena za lijek Enbrel, ponavljati za Erelzi.
English: Other information about Erelzi
Croatian: Ostale informacije o lijeku Erelzi
English: Erelzi is not for use in children who need doses other than 25 or 50 mg (e.g. those weighing less than 62.5 kg), because it is only available in these doses; an alternative product should be used in such children.
Croatian: Lijek Erelzi dostupan je samo u dozama od 25 ili 50 mg pa nije namijenjen za primjenu u djece kojima su potrebne doze druge jačine (npr. ona tjelesne težine manje od 62,5 kg); u takve je djece potrebno primjenjivati neki zamjenski lijek.
English: Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Erelzi is used for.
Croatian: Liječenje započinju i nadziru liječnici specijalisti s iskustvom u dijagnosticiranju i liječenju bolesti za koje se primjenjuje lijek Erelzi.
English: What are the risks associated with Erelzi?
Croatian: Koji su rizici povezani s lijekom Erelzi?
English: The active substance in Erelzi, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor alpha (TNF).
Croatian: Djelatna tvar u lijeku Erelzi, etanercept, protein je namijenjen blokiranju aktivnosti tvari zvane čimbenik nekroze tumora alfa (TNF).
English: It is not intended to provide practical advice on how to use Erelzi.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Erelzi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erelzi have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Erelzi nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: The reference medicine for Erelzi is Enbrel.
Croatian: Referentni lijek za Erelzi je Enbrel.
English: The injection is given under the skin and the patient or their carer can give the injection if they have been trained appropriately.
Croatian: Injekcija se daje pod kožu, a mogu je primijeniti sam bolesnik ili njegov njegovatelj ako su za to pravilno obučeni.
English: Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis.
Croatian: Tijekom prvih 12 tjedana liječenja plak psorijaze doza od 50 mg može se davati i dvaput tjedno.
English: Studies were carried out to show that Erelzi produces similar levels of the active substance in the body to Enbrel.
Croatian: Ispitivanja su provedena kako bi se pokazalo da Erelzi proizvodi slične razine djelatne tvari u tijelu kao i Enbrel.
English: • certain forms of juvenile idiopathic arthritis (diseases causing inflammation in the joints, with first appearance in childhood or adolescence);
Croatian: • nekih oblika juvenilnog idiopatskog artritisa (bolesti koje uzrokuju upalu zglobova, a prvi put se pojave u djetinjstvu ili adolescenciji);
English: Why is Erelzi approved?
Croatian: Zašto je lijek Erelzi odobren?
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Erelzi is used to treat.
Croatian: Ova je tvar uključena u nastajanje upale i pronađena je u velikim koncentracijama u bolesnika s bolestima koje se liječe lijekom Erelzi.
English: What benefits of Erelzi have been shown in studies?
Croatian: Koje su koristi lijeka Erelzi dokazane u ispitivanjima?
English: Laboratory studies comparing Erelzi with Enbrel have shown that the active substance in Erelzi is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima se Erelzi uspoređivao s lijekom Enbrel, pokazala su da je djelatna tvar u lijeku Erelzi vrlo slična onoj u lijeku Enbrel u pogledu strukture, čistoće i biološkog djelovanja.
English: Erelzi is available as prefilled syringes and pens containing a solution for injection.
Croatian: Erelzi je dostupan u napunjenim štrcaljkama i brizgalicama koje sadrže otopinu za injekciju.
English: • rheumatoid arthritis (a disease causing inflammation of the joints) in adults, used with another medicine, methotrexate, or alone;
Croatian: • reumatoidnog artritisa (bolesti koja uzrokuje upalu zglobova) u odraslih, a primjenjuje se s još jednim lijekom, metotreksatom, ili samostalno;
English: • axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when there are no abnormalities seen on x-ray.
Croatian: • aksijalnog spondiloartritisa (kronične upalne bolesti kralježnice) u odraslih kada se abnormalnosti ne vide na rendgenskim snimkama.
English: For more information about treatment with Erelzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Erelzi pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Erelzi contains the active substance etanercept and is a ‘biosimilar medicine'.
Croatian: Erelzi sadrži djelatnu tvar etanercept te je „biosličan lijek”.
English: How is Erelzi used?
Croatian: Kako se Erelzi koristi?
English: Therefore, the CHMP's view was that, as for Enbrel, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje identificirani rizik, kao i za lijek Enbrel.
English: For practical information about using Erelzi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Erelzi bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children;
Croatian: • plak psorijaze (bolesti koja uzrokuje crvene ljuskave lezije na koži) u odraslih i djece;
English: For detailed information on the use of Erelzi in all conditions, see the summary of product characteristics (also part of the EPAR).
Croatian: Detaljne informacije o primjeni lijeka Erelzi u svim bolestima potražite u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults;
Croatian: • ankilozantnog spondilitisa (bolesti koja uzrokuje upalu zglobova kralježnice) u odraslih;
English: • psoriatic arthritis (psoriasis with inflammation of the joints) in adults and adolescents;
Croatian: • psorijatičnog artritisa (psorijaza s upalom zglobova) u odraslih i adolescenata;
English: How does Erelzi work?
Croatian: Kako djeluje Erelzi?
English: Erelzi was also shown to be as effective as Enbrel in one main study involving 531 adults with plaque psoriasis.
Croatian: U jednom glavnom ispitivanju koje je obuhvaćalo 531 odraslog bolesnika s plak psorijazom, Erelzi se pokazao jednako djelotvoran kao i Enbrel.
English: For the full list of all side effects reported with Erelzi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Erelzi potražite u uputi o lijeku.
English: This effect increases with higher doses and/or repeated treatments.
Croatian: Taj se učinak povećava kod povećanih doza i/ili ponavljanih tretmana.
English: The dose is adjusted to the colony size.
Croatian: Doza se prilagođava veličini kolonije.
English: Heavily contaminated clothes should be changed immediately and washed before re-use.
Croatian: Jako kontaminiranu odjeću treba odmah skinuti i oprati je prije ponovne uporabe.
English: This summary was last updated in October 2016.
Croatian: Sažetak je posljednji put ažuriran u 10-2016.
English: People must not eat, drink or smoke while using the medicine.
Croatian: Prilikom korištenja proizvoda ne smije se jesti, piti niti pušiti.
English: In each location 20 test groups were compared to 12 control groups treated with flumethrin (another medicine effective against parasites).
Croatian: Na svakoj lokaciji 20 ispitnih skupina uspoređeno je s 12 kontrolnih skupina koje su tretirane flumetrinom (drugi VMP koji je djelotvoran protiv parazita).
English: The effectiveness of VarroMed was investigated in field studies in European countries with different climates, both continental climate and Mediterranean climate.
Croatian: Djelotvornost VMP-a VarroMed istraživana je u terenskim ispitivanjima u europskim zemljama s različitim klimama, kako kontinentalnom tako i mediteranskom klimom.
English: The full EPAR for VarroMed can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP VarroMed nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Treatment should be given in the late afternoon or evening when bees are less likely to be flying.
Croatian: Tretman treba provesti u kasno poslijepodne ili u večernjim satima, kada pčele manje lete.
English: People should avoid contact with the skin, eyes and mucous membranes (moist body surfaces such as lining of mouth).
Croatian: Ljudi trebaju izbjegavati kontakt s kožom, očima i sluznicom (vlažne površine tijela, kao što je sluznica usne šupljine).
English: The average effectiveness of VarroMed to kill mites (measured by the number of dead mites found at the bottom of the hive) was 88% for winter, 92% for spring and 85% for autumn treatments.
Croatian: Prosječna djelotvornost VMP-a VarroMed u ubijanju grinja (izmjerena brojem mrtvih grinja na dnu košnice) bila je 88 % u zimskom tretiranju, 92 % u proljetnom tretiranju i 85 % u jesenskom tretiranju.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Croatian: On objašnjava kako je Agencija ocijenila ovaj veterinarsko-medicinski proizvod (VMP) kako bi preporučila njegovo odobrenje u Europskoj uniji (EU) i uvjete za njegovu primjenu.
English: The groups were treated during winter (in the absence of brood), spring and autumn (in the presence of brood) and included colonies of different sizes (5,000 to 30,000 bees) and different infestation levels.
Croatian: Skupine su tretirane tijekom zime (u razdoblju bez legla), proljeća i jeseni (u razdoblju razvoja legla) i uključivale su kolonije različitih veličina (5000 do 30 000 pčela) i različite razine infestacije.
English: Varroa mite and honey bee mortality were monitored twice weekly for 4 weeks during treatment until one week after treatment.
Croatian: Smrtnost grinja varoe i medonosnih pčela praćena je dvaput tjedno tijekom četiri tjedna za vrijeme tretiranja i jedan tjedan nakon tretiranja.
English: Why is VarroMed approved?
Croatian: Zašto je VarroMed odobren?
English: What is VarroMed and what is it used for?
Croatian: Što je VarroMed i za što se koristi?
English: In case of accidental spillage into the eye(s) flush the eye(s) immediately with clear running water for 10 minutes.
Croatian: U slučaju da se nehotice prolije u oko (oči), smjesta isperite oko (oči) mlazom bistre tekuće vode u trajanju od 10 minuta.
English: VarroMed is intended to be used as part of an integrated varroa control programme, which includes other techniques.
Croatian: VMP VarroMed namijenjen je za primjenu u okviru cjelovitog programa za kontrolu varoe, koji uključuje i druge tehnike.
English: The European Commission granted a marketing authorisation valid throughout the EU for VarroMed on 2 February 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP VarroMed na snazi u Europskoj uniji od 02/02/2017.
English: It can be used either as a single-dose treatment during the broodless period (winter treatment), or in the presence of brood (spring or autumn treatment) which will usually require repeated treatments.
Croatian: Može se primjenjivati kod liječenja primjenom jednokratne doze tijekom razdoblja bez legla (zimsko tretiranje) ili tijekom razdoblja razvoja legla (proljetno ili jesenje tretiranje), kada je uglavnom potrebno ponavljanje tretmana.
English: The most common side effect with VarroMed (which may affect more than 1 in 10 bee colonies) is an increased number of deaths of worker bees.
Croatian: Najčešća nuspojava VMP-a VarroMed (može se javiti u više od 1 na 10 kolonija pčela) jest povećana smrtnost pčela radilica.
English: VarroMed oxalic acid dihydrate / formic acid
Croatian: VarroMed dihidrat oksalne kiseline/mravlja kiselina
English: VarroMed is irritating to the skin and eyes.
Croatian: VMP VarroMed nadražuje kožu i oči.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that VarroMed'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 VarroMed nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The withdrawal period for honey from honey bees treated with VarroMed for is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za med medonosnih pčela liječenih VMP-om VarroMed iznosi „nula” dana, drugim riječima, nema obveznog perioda čekanja.
English: Protective clothing, acid-resistant gloves and glasses should be worn during treatment.
Croatian: Tijekom tretiranja treba nositi zaštitnu odjeću, rukavice otporne na kiseline i zaštitne naočale.
English: In case of accidental spillage onto skin, the affected areas should be washed immediately with running water.
Croatian: U slučaju da se nehotice prolije na kožu, smjesta isperite zahvaćena područja tekućom vodom.
English: A significant mite infestation can lead to the collapse of a honey bee colony.
Croatian: Veća infestacija grinjama može dovesti do propasti kolonije medonosnih pčela.
English: This is a summary of the European public assessment report (EPAR) for VarroMed.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu VarroMed.
English: Children should be kept from contact with VarroMed.
Croatian: Treba osigurati da djeca ne dolaze u kontakt s VMP-om VarroMed.
English: Varroosis is a disease of honey bees caused by infestation with a parasite called Varroa mite (Varroa destructor).
Croatian: Varooza je bolest medonosnih pčela uzrokovana infestacijom parazitom pod nazivom grinja varoe (Varroa destructor).
English: It is not intended to provide practical advice on how to use VarroMed.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a VarroMed.
English: People who are hypersensitive (allergic) to formic acid or oxalic acid should give the medicine with caution.
Croatian: Osobe koje su preosjetljive (alergične) na mravlju ili oksalnu kiselinu trebaju oprezno postupati s veterinarsko medicinskim proizvodom.
English: What are the risks associated with VarroMed?
Croatian: Koji su rizici povezani s VMP-om VarroMed?
English: How both oxalic acid and formic acid work is not well understood.
Croatian: Način djelovanja oksalne kiseline i mravlje kiseline nije u potpunosti poznat.
English: VarroMed is a medicine used to treat varroosis in honey bee colonies.
Croatian: VarroMed je VMP koji se koristi za liječenje varooze u kolonijama medonosnih pčela.
English: VarroMed must not be given during nectar flow, when honey is produced by bees, and should not be used when honey chambers are attached to the hive.
Croatian: VMP VarroMed ne smije se primjenjivati tijekom unosa nektara, kada pčele proizvode med, niti kada su komore za med pričvršćene za košnicu.
English: The Varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in damage and / or death of bees; the mite can also help spread of viruses and bacteria.
Croatian: Grinje varoe hrane se hemolimfom (krvi) odraslih pčela i leglom (razvojne faze medonosne pčele) što rezultira oštećenjem i/ili smrću pčela.
English: VarroMed is available as a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Croatian: VMP VarroMed dostupan je kao disperzija za košnice (tekućina za korištenje unutar košnice) i može se dobiti bez veterinarskog recepta.
English: VarroMed contains the active substances oxalic acid dihydrate and formic acid.
Croatian: VMP VarroMed sadrži djelatne tvari dihidrat oksalne kiseline i mravlju kiselinu.
English: The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći od primjene VMP-a prije nego što ljudi mogu konzumirati med.