FrancophonIA/ELRC3.0 huggingface dataset:
English: • The benefits and risks of fluoroquinolones will be monitored continuously and a drug utilisation study will evaluate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by investigating changes in prescribing behaviour.
Croatian: • Provodit će se stalan nadzor koristi i rizika fluorokinolona, a u okviru ispitivanja uporabe lijeka procijenit će se učinkovitost novih mjera za smanjenje neprikladne primjene fluorokinolona istraživanjem promjena u ponašanju osoba koje propisuju lijek.
English: They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury.
Croatian: Potreban je poseban oprez pri primjeni u starijih osoba, bolesnika s bolesti bubrega i onih koji su imali transplantaciju organa jer su ti bolesnici izloženi većem riziku od ozljede tetive.
English: • You may be more prone to joint pain or swelling or tendon damage if you are aged over 60 years, your kidneys do not work well or you have received organ transplantation.
Croatian: • Moguće je da ćete biti skloniji bolovima u zglobovima ili oticanju zglobova ili oštećenju tetiva ako ste stariji od 60 godina, ako vam bubrezi ne rade dobro ili ste imali transplantaciju organa.
English: EMA's human medicines committee (CHMP) endorsed the recommendations of EMA's safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended.
Croatian: EMA-in Odbor za lijekove za humanu uporabu (CHMP) prihvatio je preporuke EMA-ina Odbora za procjenu rizika u području farmakovigilancije (PRAC) i zaključio da je potrebno privremeno oduzeti odobrenje za stavljanje u promet lijekova koji sadržavaju cinoksacin, flumekin, nalidiksičnu kiselinu i pipemidičnu kiselinu.
English: You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time.
Croatian: Možete biti posebno skloni oštećenju tetiva ako istodobno uzimate kortikosteroid i lijek koji sadrži fluorokinolon.
English: The review incorporated the views of patients, healthcare professionals and academics presented at EMA's public hearing on fluoroquinolone and quinolone antibiotics in June 2018.
Croatian: Ocjenjivanjem su bila obuhvaćena stajališta bolesnika, zdravstvenih radnika i akademika iznesena na javnoj raspravi EMA-e o fluorokinolonskim i kinolonskim antibioticima u lipnju 2018.
English: • Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment.
Croatian: • Oštećenje tetive (osobito Ahilove, ali i drugih tetiva) može se javiti unutar 48 sati od početka liječenja fluorokinolonima, ali oštećenja mogu nastupiti i nekoliko mjeseci nakon prestanka liječenja.
English: Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
Croatian: Potrebno je izbjegavati istodobno liječenje fluorokinolonom i kortikosteroidom.
English: • Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses.
Croatian: • Fluorokinoloni su povezani s produljenim ozbiljnim, onesposobljavajućim i potencijalno ireverzibilnim reakcijama na lijek (koje mogu trajati mjesecima ili godinama), koje utječu na nekoliko organskih sustava i osjetila, a ponekad istodobno i više njih.
English: • Tendon swelling and injury may occur within 2 days of starting treatment with a fluoroquinolone but may even occur several months after stopping treatment.
Croatian: • Oticanje i ozljede tetive mogu nastupiti unutar dva dana od početka liječenja fluorokinolonima, ali čak i nekoliko mjeseci nakon prestanka liječenja.
English: The review covered medicines containing the following fluoroquinolone and quinolone antibiotics: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.
Croatian: Ocjenjivanjem su bili obuhvaćeni lijekovi koji sadrže sljedeće fluorokinolonske i kinolonske antibiotike: cinoksacin, ciprofloksacin, flumekin, levofloksacin, lomefloksacin, moksifloksacin, nalidiksična kiselina, norfloksacin, ofloksacin, pefloksacin, pipemidična kiselina, prulifloksacin i rufloksacin.
English: • Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation and patients should be advised to stop treatment with a fluoroquinolone and speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness so as to prevent development of potentially irreversible condition.
Croatian: • Liječenje fluorokinolonima treba prekinuti kod prvog znaka boli ili upale tetive, a bolesnicima je potrebno savjetovati da prekinu liječenje fluorokinolonom i obrate se svojem liječniku ako imaju simptome neuropatije poput boli, žarenja, trnaca, utrnulosti ili slabosti kako bi se spriječio razvoj potencijalno ireverzibilnog stanja.
English: In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.
Croatian: Osim toga, informacije za propisivanje lijekova namijenjene zdravstvenim radnicima i informacije za bolesnike sadržavat će opis onesposobljavajućih i potencijalno trajnih nuspojava te savjet bolesnicima da prekinu liječenje fluorokinolonskim antibioticima kod prvog znaka nuspojava koje zahvaćaju mišiće, tetive ili zglobove i živčani sustav.
English: o if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms;
Croatian: o ako osjetite bol, probadanje i trnce, škakljanje, utrnulost ili žarenje, ili slabost, posebno u nogama ili rukama;
English: • Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.
Croatian: • Lijekovi koji sadrže fluorokinolone (ciprofloksacin, levofloksacin, lomefloksacin, moksifloksacin, norfloksacin, ofloksacin, pefloksacin, prulifloksacin i rufloksacin) mogu uzrokovati dugotrajne, onesposobljavajuće i potencijalno trajne nuspojave koje zahvaćaju tetive, mišiće, zglobove i živčani sustav.
English: Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic.
Croatian: Važno je izbjegavati fluorokinolone u bolesnika koji su prethodno imali ozbiljne nuspojave s fluorokinolonskim ili kinolonskim antibiotikom.
English: • Patients who are older, have renal impairment or have had solid organ transplantation and those being treated with a corticosteroid are at higher risk of tendon damage.
Croatian: • Stariji bolesnici, bolesnici s oštećenjem funkcije bubrega ili s presađenim solidnim organima te bolesnici koji se liječe kortikosteroidima izloženi su povećanom riziku od oštećenja tetive.
English: On 15 November 2018, EMA finalised a review of serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation.
Croatian: Europska agencija za lijekove dovršila je 15. studenoga 2018. ocjenjivanje ozbiljnih, onesposobljavajućih i potencijalno trajnih nuspojava kinolonskih i fluorokinolonskih antibiotika koji se primjenjuju peroralno, injekcijom ili inhalacijom.
English: o if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing.
Croatian: o ako vam rame, ruke ili noge postanu otečene, imate poteškoća s hodanjem, osjećate umor ili depresiju ili imate problema s pamćenjem ili spavanjem ili zamijetite promjene osjeta vida, okusa, mirisa ili sluha.
English: • You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.
Croatian: • Ne smijete uzimati lijek koji sadrži fluorokinolon ako ste ikada imali ozbiljnu nuspojavu pri primjeni lijeka koji sadrži fluorokinolon ili kinolon te se trebate odmah obratiti svojem liječniku.
English: • Fluoroquinolones should generally not be used in patients who have had serious adverse reactions associated with the use of quinolone or fluoroquinolone medicines.
Croatian: • Fluorokinoloni se općenito ne smiju primjenjivati u bolesnika koji su imali ozbiljne nuspojave povezane s primjenom lijekova koji sadrže fluorokinolon ili kinolon.
English: • The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.
Croatian: • Ozbiljne nuspojave uključuju tendonitis, rupturu tetive, artralgiju, bol u ekstremitetima, poremećaj hodanja, neuropatiju povezanu s parestezijom, depresiju, umor, narušeno pamćenje, poremećaje spavanja, oštećenje sluha, vida, okusa i njuha.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 14 February 2019 for Quinsair and on 11 March 2019 for other quinolone and fluoroquinolone antibiotics given by mouth and by injection, which is applicable in all EU countries.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je 14. veljače 2019. donijela pravno obvezujuću odluku za lijek Quinsair, a 11. ožujka 2019. za ostale kinolonske i fluorokinolonske antibiotike koji se primjenjuju peroralno i injekcijom.
English: • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
Croatian: • Te ozbiljne nuspojave uključuju upaljenu ili razderanu tetivu, bol u mišićima ili mišićnu slabost, bol u zglobovima ili oticanje zglobova, otežano hodanje, osjet probadanja i trnaca, žareću bol, umor, depresiju, probleme s pamćenjem, spavanjem, vidom i sluhom, te izmijenjen osjet okusa i mirisa.
English: • Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine.
Croatian: • Prilikom razmatranja liječenja lijekom koji sadrži fluorokinolon potrebno je proučiti odobrene indikacije u ažuriranom sažetku opisa svojstava lijeka.
English: Patientsor their carers may inject the medicine themselves if their doctor or nurse considers it appropriate.
Croatian: Bolesnici ili njihovi njegovatelji mogu si sami ubrizgati lijek ako to njihov liječnik ili medicinska sestra smatraju prikladnim.
English: Further information on Dupixent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dupixent.
Croatian: Više informacija o lijeku Dupixent dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/dupixentema.europa.eu/medicines/human/EPAR/dupixent.
English: Dupixent received a marketing authorisation valid throughout the EU on 27 September 2017.
Croatian: Lijek Dupixent dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 27. rujna 2017.
English: Anaphylaxis (sudden, severe allergic reaction) has been reported very rarely.
Croatian: Anafilaksija (iznenadna ozbiljna alergijska reakcija) zabilježena je vrlo rijetko.
English: What is Dupixent and what is it used for?
Croatian: Što je Dupixent i za što se koristi?
English: A further study was carried out in 251 adolescents aged from 12 to less than 18 years with moderate to severe atopic dermatitis.
Croatian: Provedeno je dodatno ispitivanje na 251 adolescentu u dobi od 12 manje od 18 godina s umjerenim do teškim atopijskim dermatitisom.
English: What measures are being taken to ensure the safe and effective use of Dupixent?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Dupixent?
English: The medicine is for long-term use and the need to continue taking the medicine should be assessed by the doctor at least yearly.
Croatian: Lijek je namijenjen dugotrajnoj primjeni, a potrebu za nastavkom terapije treba barem jednom godišnje procijeniti liječnik.
English: Why is Dupixent authorised in the EU?
Croatian: Zašto je Dupixent odobren u EU-u?
English: Other information about Dupixent
Croatian: Ostale informacije o lijeku Dupixent
English: Side effects reported with Dupixent are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Dupixent pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: As for all medicines, data on the use of Dupixent are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Dupixent kontinuirano se prate.
English: What are the risks associated with Dupixent?
Croatian: Koji su rizici povezani s lijekom Dupixent?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dupixent have 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 Dupixent nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: An overview of Dupixent and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Dupixent i zašto je odobren u EU-u
English: The European Medicines Agency therefore decided that Dupixent's benefits are greater than its risks and it can be authorised in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Dupixent nadmašuju s njim povezane rizike te da lijek može biti odobren u Europskoj uniji.
English: After 12 weeks of treatment, Dupixent improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 320 ml (for 200 mg Dupixent) or 340 ml (for 300 mg Dupixent) compared with 180 ml and 210 ml for placebo.
Croatian: Nakon 12 tjedana liječenja, Dupixent je poboljšao FEV1 (najveći volumen zraka koji osoba može izdahnuti u jednoj sekundi) bolesnika za 320 ml (kad je primjenjivan Dupixent od 200 mg ) ili 340 ml (kad je primjenjivan Dupixent od 300 mg) u usporedbi sa 180 ml i 210 ml kod placeba.
English: Dupixent is available as pre-filled syringes containing 200 mg or 300 mg dupilumab in a solution for injection under the skin, usually in the thigh or belly.
Croatian: Dupixent je dostupan u napunjenim štrcaljkama koje sadrže 200 mg ili 300 mg dupilumaba u otopini za injekciju pod kožu, obično u bedro ili trbuh.
English: In adolescents weighing less than 60 kg, the 200-mg injection is used.
Croatian: U adolescenata tjelesne težine manje od 60 kg koristi se injekcija od 200 mg.
English: The active substance in Dupixent, dupilumab, is a monoclonal antibody (a type of protein) designed to block receptors (targets) for IL-4 and IL-13.
Croatian: Djelatna tvar u lijeku Dupixent, dupilumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno blokiranju receptora (ciljnih mjesta) za IL-4 i IL-13.
English: There have been very rare cases of serum sickness (allergy to foreign proteins) and serum sickness-like reactions.
Croatian: U vrlo rijetkim slučajevima zabilježena je i serumska bolest (alergija na strane bjelančevine) i reakcije slične serumskoj bolesti.
English: Patients with atopic dermatitis and patients with asthma produce high levels of proteins called interleukin 4 and interleukin 13 (IL-4 and IL-13), which can cause inflammation of the skin and airways leading to the symptoms of these diseases.
Croatian: Bolesnici s atopijskim dermatitisom i bolesnici s astmom proizvode visoke razine bjelančevina naziva interleukin 4 i interleukin 13 (IL-4 i IL-13) koji mogu izazvati upalu kože i dišnih puteva, što uzrokuje simptome tih bolesti.
English: In the first study, involving 1,902 patients, the number of severe flare-ups per year was 0.46 in patients taking 200 mg Dupixent and 0.52 in patients taking 300 mg Dupixent, compared with 0.87 or 0.97 in patients given placebo.
Croatian: U prvom ispitivanju koje je uključivalo 1 902 bolesnika, broj ozbiljnih razbuktavanja godišnje iznosio je 0,46 u bolesnika koji su primali Dupixent od 200 mg i 0,52 u bolesnika koji su primali Dupixent od 300 mg, u usporedbi s 0,87 ili 0,97 u bolesnika koji su primali placebo.
English: Regarding safety, Dupixent's side effects are generally mild and manageable.
Croatian: U pogledu sigurnosti, nuspojave lijeka Dupixent uglavnom su blage i može ih se kontrolirati.
English: For all other asthma patients, the first dose is two injections of 200 mg in two different sites.
Croatian: Kod svih drugih bolesnika s astmom prva se doza sastoji od dvije injekcije od 200 mg na dva različita mjesta.
English: In the first study, which involved 740 patients, participants were given Dupixent or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin).
Croatian: U prvom ispitivanju koje je uključivalo 740 bolesnika ispitanici su primali Dupixent ili placebo, oboje u kombinaciji s topikalnim kortikosteroidom (protuupalni lijek koji se nanosi na kožu).
English: For more information about using Dupixent, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Dupixent pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Dupixent is also used to treat severe asthma in patients aged 12 years or over whose asthma is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Croatian: Dupixent se koristi i za liječenje teške astme u bolesnika u dobi od 12 godina ili starijih čiju se astmu ne može odgovarajuće kontrolirati kombinacijom visokih doza inhalacijskih kortikosteroida i drugim lijekom za prevenciju astme.
English: Dupixent can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the conditions Dupixent is used to treat.
Croatian: Dupixent se izdaje samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju bolesti za koje je namijenjen Dupixent.
English: The doctor will consider stopping treatment if the condition does not show any improvement after 16 weeks.
Croatian: Ako se stanje ne poboljša nakon 16 tjedana, liječnik će razmotriti mogućnost prestanka terapije.
English: The most common side effects with Dupixent when used in treatment of atopic dermatitis are injectionsite reactions (such as redness, swelling and itching),which may affect more than 1 in 10 people, and conjunctivitis (redness and discomfort in the eye), blepharitis (inflammation of the eyelid) and cold sores, which may affect up to 1 in 10 people.
Croatian: Najčešće nuspojave lijeka Dupixent pri liječenju atopijskog dermatitisa su reakcije na mjestu primjene injekcije (poput crvenila, oticanja i svrbeža) koje se mogu javiti u više od 1 na 10 osoba te konjunktivitis (crvenilo i nelagoda u oku), blefaritis (upala vjeđe) i herpes koje se mogu javiti u do 1 na 10 osoba.
English: This is followed by one 300 mg injection every two weeks.
Croatian: Nakon toga slijedi jedna injekcija od 300 mg svaka dva tjedna.
English: What benefits of Dupixent have been shown in studies?
Croatian: Koje su koristi od lijeka Dupixent utvrđene u ispitivanjima?
English: Dupixent is a medicine used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry).
Croatian: Dupixent je lijek za liječenje bolesnika u dobi od 12 godina i starijih s umjerenim do teškim atopijskim dermatitisom (poznatim i kao atopijski ekcem koji obilježavaju svrbež, crvenilo i suhoća kože).
English: By blocking the receptors, dupilumab prevents IL-4 and IL-13 from working and relieves disease symptoms.
Croatian: Blokiranjem receptora dupilumab sprječava djelovanje proteina IL-4 i IL-13 i olakšava simptome bolesti.
English: For severe asthma, in patients taking corticosteroids by mouth or patients who also have atopic dermatitis, the first dose is two injections of 300 mg in two different sites.
Croatian: Kod teške astme, u bolesnika koji uzimaju kortikosteroide na usta ili u onih koji usto imaju i atopijski dermatitis, prva se doza sastoji od dvije injekcije od 300 mg na dva različita mjesta.
English: Dupixent has been shown to reduce the extent and severity of atopic dermatitis in patients with moderate to severe disease, for whom available therapies are limited.
Croatian: Pokazalo se da Dupixent smanjuje opseg i težinu atopijskog dermatitisa u bolesnika s umjerenim do teškim stadijem bolesti za koje su dostupne terapije ograničene.
English: Dupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in patients with moderate to severe disease.
Croatian: Dupixent je bio učinkovitiji od placeba (prividnog liječenja) u smanjenju opsega i težine atopijskog dermatitisa u tri glavna ispitivanja provedena u bolesnika s umjerenim do teškim stadijem bolesti.
English: The second study, involving 210 patients, showed that in 70% of patients given Dupixent their condition improved to the extent that they could reduce their dose of corticosteroids taken by mouth compared with 42% of those given placebo.
Croatian: U trećem ispitivanju koje je obuhvatilo 210 bolesnika utvrđeno je da se stanje u 70 % bolesnika koji su primali Dupixent poboljšalo u mjeri dovoljnoj za smanjenje doze kortikosteroida koji se uzimaju na usta u usporedbi s 42 % bolesnika koji su primali placebo.
English: How does Dupixent work?
Croatian: Kako djeluje Dupixent?
English: Dupixent is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation'.
Croatian: Lijek Dupixent koristi se samo u bolesnika s vrstom upale dišnih puteva koja se naziva „upala tipa 2”.
English: This is followed by one 200-mg injection every two weeks.
Croatian: Nakon toga slijedi jedna injekcija od 200 mg svaka dva tjedna.
English: In this study, after 16 weeks atopic dermatitis had cleared up or almost cleared up in around 24% of those given Dupixent every 2 weeks compared with around 2% of those given placebo.
Croatian: U tom je ispitivanju nakon 16 tjedana atopijski dermatitis nestao ili gotovo potpuno nestao u otprilike 24 % osoba koje su primale lijek Dupixent svaka dva tjedna, u usporedbi s otprilike 2 % onih koji su primali placebo.
English: In the treatment of asthma, Dupixent has been shown to reduce the number of asthma flare-ups and the need for oral corticosteroid treatment.
Croatian: U liječenju astme pokazalo se da Dupixent smanjuje broj razbuktavanja astme i potrebu za terapijom kortikosteroidima koji se uzimaju na usta.
English: The most common side effect with Dupixent when used in treatment of asthma is redness at the site of injection.
Croatian: Najčešća nuspojava lijeka Dupixent pri liječenju astme bilo je crvenilo na mjestu primjene injekcije.
English: For atopic dermatitis, the first dose in adults and adolescents weighing 60 kg or more is two injections of 300 mg in two different sites.
Croatian: Za liječenje atopijskog dermatitisa u odraslih osoba i adolescenata tjelesne težine od 60 kg i više prva se doza sastoji od dvije injekcije od 300 mg na dva različita mjesta.