FrancophonIA/ELRC3.0 huggingface dataset:
English: If needed, treatment can be repeated for a third time after an additional 6 hours.
Croatian: Ako je potrebno, postupak se može ponoviti treći put nakon sljedećih šest sati.
English: If symptoms continue or come back, a second injection can be given after 6 hours.
Croatian: Ako se simptomi ne povuku ili se vrate, nakon šest sati može se dati druga injekcija.
English: Other information about Firazyr
Croatian: Ostale informacije o lijeku Firazyr
English: The European Commission granted a marketing authorisation valid throughout the European Union for Firazyr on 11 July 2008.
Croatian: Europska komisija dala je odobrenje za stavljanje lijeka Firazyr u promet koje vrijedi na prostoru Europske unije od 11. srpnja 2008.
English: What measures are being taken to ensure the safe and effective use of Firazyr?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Firazyr?
English: This is a summary of the European public assessment report (EPAR) for Firazyr.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Firazyr.
English: What is Firazyr and what is it used for?
Croatian: Što je Firazyr i za što se koristi?
English: No more than three injections should be given in any 24-hour period.
Croatian: Tijekom razdoblja od 24 sata ne smije se dati više od tri injekcije.
English: The main measure of effectiveness was how long it took for the patient's symptoms to be relieved.
Croatian: Glavna mjera djelotvornosti bilo je vrijeme potrebno za ublažavanje simptoma u bolesnika.
English: The European Medicines Agency decided that Firazyr's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Firazyr nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: Each pre-filled syringe of Firazyr contains 30 mg icatibant in 3 ml.
Croatian: Svaka napunjena štrcaljka Firazyra sadržava 30 mg ikatibanta u 3 ml.
English: The full EPAR for Firazyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Firazyr nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The doctor may decide that the patient or their caregiver can inject the medicine themselves, after they have been properly trained by a healthcare professional.
Croatian: Liječnik može odlučiti da bolesnik ili njegov njegovatelj samostalno daju injekciju, ali tek nakon što ih je zdravstveni radnik tomu podučio.
English: This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.
Croatian: Time se sprječava djelovanje bradikinina i ublažavaju simptomi bolesti.
English: Firazyr can only be obtained with a prescription.
Croatian: Firazyr se izdaje samo na liječnički recept.
English: It is not intended to provide practical advice on how to use Firazyr.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Firazyr.
English: What are the risks associated with Firazyr?
Croatian: Koji su rizici povezani s lijekom Firazyr?
English: Attacks of hereditary angioedema can be life threatening when they involve the throat.
Croatian: Napadaji nasljednog angioedema mogu biti opasni po život ako zahvate grlo.
English: Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'.
Croatian: Firazyr se primjenjuje u bolesnika u kojih je angioedem povezan s prirodno niskom razinom proteina naziva „inhibitor C1-esteraze”.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Firazyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Firazyr nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The recommended dose of Firazyr in adults is one injection (3 ml).
Croatian: Preporučena je doza lijeka Firazyr za odrasle jedna injekcija (3 ml).
English: Because the number of patients with angioedema is low, the disease is considered ‘rare', and Firazyr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
Croatian: Budući da je broj bolesnika s angioedemom nizak, ta se bolest smatra „rijetkom” te je lijek Firazyr dobio status „lijeka za rijetke bolesti” 17. veljače 2003.
English: In both studies, the time it took for symptoms to improve was shorter for patients taking Firazyr than the comparator medicine.
Croatian: U oba ispitivanja vrijeme potrebno za ublažavanje simptoma bilo je kraće u bolesnika koji su primali lijek Firazyr nego u onih koji su primali usporedni lijek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Firazyr 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 Firazyr nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In another study involving 22 adolescents and children aged over 2 years with hereditary angioedema, symptoms improved on average 1 hour after the patients received Firazyr.
Croatian: U drugom ispitivanju koje je obuhvatilo 22 adolescenata i djece starije od dvije godine s nasljednim angioedemom došlo je do ublažavanja simptoma u prosjeku sat vremena nakon što su bolesnici primili lijek Firazyr.
English: Firazyr is a medicine used to treat the symptoms of attacks of hereditary angioedema in adults, adolescents and children aged over 2 years.
Croatian: Firazyr je lijek za liječenje simptoma napadaja nasljednog (hereditarnog) angioedema u odraslih, adolescenata i djece starije od dvije godine.
English: Why is Firazyr approved?
Croatian: Zašto je lijek Firazyr odobren?
English: Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Croatian: Bolesnici s angioedemom imaju napadaje oticanja koji mogu nastupiti na bilo kojem dijelu tijela, primjerice na licu, udovima ili oko crijeva, pri čemu uzrokuju nelagodu i bol.
English: The medicine is given by injecting it slowly under the skin, preferably in the abdomen (belly).
Croatian: Lijek se polako uštrcava pod kožu, po mogućnosti u području abdomena (trbuha).
English: The first study compared Firazyr with tranexamic acid (another medicine for hereditary angioedema) in 74 patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients.
Croatian: U prvom ispitivanju lijek Firazyr uspoređen je s traneksamskom kiselinom (drugim lijekom protiv nasljednog angioedema) u 74 bolesnika, a u drugom ispitivanju lijek Firazyr uspoređen je s placebom (prividnim liječenjem) u 56 bolesnika.
English: For more information about treatment with Firazyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Firazyr pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: The active substance in Firazyr, icatibant, blocks the receptors that bradykinin normally attaches to.
Croatian: Djelatna tvar lijeka Firazyr, ikatibant, blokira receptore na koje se bradikinin obično vezuje.
English: Firazyr was found to relieve swelling in the skin and abdomen, as well as swelling of the throat.
Croatian: Utvrđeno je da lijek Firazyr smanjuje oticanje na koži i abdomenu, kao i oticanje u grlu.
English: The most common side effects with Firazyr (seen in more than 1 patient in 10) are injection site reactions including erythema (redness), swelling, burning, itching and pain at injection sites.
Croatian: Najčešće su nuspojave lijeka Firazyr (zabilježene u više od 1 bolesnika od 10) reakcije na mjestu injiciranja, uključujući eritem (crvenilo), oticanje, osjećaj žarenja, svrbež i bol na mjestu injiciranja.
English: Patients' symptoms were relieved on average 2 to 2.5 hours after receiving Firazyr, compared with 12 hours for tranexamic acid in one study and 4.6 hours for placebo in the other study.
Croatian: U bolesnika koji su primali lijek Firazyr do ublažavanja simptoma došlo je u prosjeku nakon 2 do 2,5 sata, u usporedbi s 12 sati u bolesnika koji su primali transeksamsku kiselinu, u jednom ispitivanju, te 4,6 sati u onih koji su primali placebo, u drugom ispitivanju.
English: For practical information about using Firazyr, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Firazyr bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How is Firazyr used?
Croatian: Kako se Firazyr koristi?
English: What benefits of Firazyr have been shown in studies?
Croatian: Koje su koristi lijeka Firazyr utvrđene u ispitivanjima?
English: Firazyr was also found effective among patients included in the two studies who had attacks of angioedema that affected the throat.
Croatian: Utvrđeno je da je lijek Firazyr djelotvoran i u bolesnika iz oba ispitivanja u kojih su napadaji angioedema zahvaćali grlo.
English: Firazyr was found effective in two main studies in adults with hereditary angioedema involving the skin or the abdomen.
Croatian: Djelotvornost lijeka Firazyr potvrđena je u dvama glavnim ispitivanjima provedenima među odraslim osobama oboljelima od angioedema na koži ili abdomenu.
English: How does Firazyr work?
Croatian: Kako djeluje Firazyr?
English: For the list of all side effects and restrictions with Firazyr, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Firazyr potražite u uputi o lijeku.
English: Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which is involved in causing inflammation and swelling.
Croatian: Osobe oboljele od nasljednog angioedema imaju visoku razinu bradikinina, koji uzrokuje upalu i oticanje.
English: Firazyr icatibant
Croatian: Firazyr ikatibant
English: Firazyr contains the active substance icatibant.
Croatian: Firazyr sadržava djelatnu tvar ikatibant.
English: This summary was last updated in 11/2013.
Croatian: Sažetak je posljednji put ažuriran u 11.2013.
English: What is Vitekta and what is it used for?
Croatian: Što je Vitekta i za što se koristi?
English: The Committee also noted that there is a significant potential for interactions with other medicines, and this has been reflected in the product information.
Croatian: Povjerenstvo je napomenulo da postoji značajan potencijal za interakcije s drugim lijekovima, a to mora biti navedeno u informacijama o lijeku.
English: Vitekta must not be used with certain other medicines that may reduce its effectiveness or increase the risks of resistance.
Croatian: Vitekta se ne smije koristiti s određenim drugim lijekovima koji mogu smanjiti djelotvornost ili povećati rizik od rezistentnosti.
English: After 48 weeks, around 59% of patients treated with Vitekta (207 out of 351) responded to treatment compared with around 58% of patients treated with
Croatian: Nakon 48 tjedana, otprilike 59% bolesnika liječenih lijekom Vitekta (207 od 351) odgovorilo je na liječenje u usporedbi s 58% bolesnika liječenih raltegravirom (203 od 351).
English: The full EPAR for Vitekta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Vitekta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients who attained a viral load of less than 50 copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Croatian: Smatrano je da su bolesnici koji su postigli virusno opterećenje manje od 50 kopija/ml nakon 48 tjedana liječenja odgovorili na liječenje.
English: Regarding the safety profile of the medicine, this was not considered of concern, with side effects comparable to other similar medicines.
Croatian: U vezi sa sigurnosnim profilom lijeka, ovo se nije smatralo razlogom za zabrinutost, a nuspojave su usporedive s drugim sličnim lijekovima.
English: When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Croatian: Nakon što se enzim inhibira, virus se ne može normalno reproducirati čime se usporava širenje infekcije.
English: It is used to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Croatian: Koristi se za liječenje odraslih osoba koji su inficirani virusom humane imunodeficijencije tip 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (SIDA).
English: This is a summary of the European public assessment report (EPAR) for Vitekta.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Vitekta.
English: The most common side effects with Vitekta (which may affect up to 1 in 10 people) are headache, abdominal pain (stomach ache), diarrhoea, vomiting, nausea (feeling sick), rash, fatigue (tiredness).
Croatian: Najčešće nuspojave lijeka Vitekta (kod više od 1 na 10 osoba) su glavobolja, abdominalna bol (bol u trbuhu), proljev, povraćanje, mučnina (osjećaj slabosti), osip, izmorenost (umor).
English: Vitekta does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Vitekta ne liječi infekciju HIV-a ili SIDA-e, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s SIDA-om.
English: Vitekta is taken either at the same time as a once-daily protease inhibitor, or with the first dose of a twice-daily protease inhibitor.
Croatian: Vitekta se uzima ili u isto vrijeme kao inhibitor proteaze koji se uzima jednom dnevno ili s prvom dozom inhibitora proteaza koji se uzima dvaput dnevno.
English: The main measure of effectiveness was based on the reduction in the levels of HIV in the blood (viral load).
Croatian: Glavna mjera djelotvornosti temeljila se na snižavanju razine HIV-a u krvi (virusno opterećenje).
English: It is not intended to provide practical advice on how to use Vitekta.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Vitekta.
English: What are the risks associated with Vitekta?
Croatian: Koji su rizici povezani s lijekom Vitekta?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vitekta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Vitekta nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: The choice of dose of Vitekta depends on which other medicines it is given with.
Croatian: Odabir doze lijeka Vitekta ovisi o tome s kojim se lijekom uzima.
English: In this study, Vitekta was at least as effective as raltegravir (another integrase inhibitor) when taken in combination with other anti-HIV medicines.
Croatian: U ovom ispitivanju lijek Vitekta bio je barem jednako učinkovit kao raltegravir (drugi inhibitor integraze) ako se uzima zajedno s drugim lijekom protiv HIV-a.
English: It is used in combination with ‘protease inhibitor' medicines taken together with ritonavir, and with other anti-HIV medicines in patients whose disease is not expected to be resistant
Croatian: Koristi se u kombinaciji s „pojačanim inhibitorom proteaza” koji se uzima zajedno s ritonavirom, te s drugim lijekovima protiv HIV-a u bolesnika za čiju se bolest ne očekuje rezistentnost na elvitegravir.
English: A risk management plan has been developed to ensure that Vitekta is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vitekta.
English: Vitekta has been investigated in one main study involving 712 patients with HIV-1 who had not been treated before with an integrase inhibitor.
Croatian: Lijek Vitekta ispitan je u jednom glavnom ispitivanju koje je obuhvatilo 712 bolesnika s infekcijom HIV1 koji nisu prethodno liječeni inhibitorom integraze.
English: Vitekta can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infections.
Croatian: Vitekta se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u upravljanju infekcijama HIV-om.
English: Vitekta is available as tablets (85 and 150 mg); the recommended dose is one tablet a day, taken with food.
Croatian: Vitekta je dostupan kao tablete (85 i 150 mg).
English: The CHMP concluded that the benefits of Vitekta in reducing the levels of HIV in the blood had been clearly shown in studies.
Croatian: CHMP je zaključio da su koristi lijeka Vitekta u snižavanju razine HIV-a u krvi jasno prikazane u ispitivanju.
English: What measures are being taken to ensure the safe and effective use of
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vitekta?
English: The active substance in Vitekta, elvitegravir, is a type of antiviral agent called an ‘integrase inhibitor'.
Croatian: Djelatna tvar u lijeku Vitekta, elvitegravir, jest tip antivirusnog agensa naziva „inhibitor integraze”.
English: Vitekta is an antiviral medicine that contains the active substance elvitegravir.
Croatian: Vitekta je antivirusni lijek koji sadrži djelatnu tvar elvitegravir.
English: For more information about treatment with Vitekta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vitekta pročitajte u uputama o lijeku Vitekta (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV.
Croatian: Inhibira enzim naziva integraza, koji je uključen u korak u reprodukciji HIV-a.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vitekta, including the appropriate precautions to be followed by healthcare
Croatian: Na temelju tog plana, u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Vitekta uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza koje zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: What benefits of Vitekta have been shown in studies?
Croatian: Koje su koristi lijeka Vitekta dokazane u ispitivanjima?
English: For practical information about using Vitekta, patients should read the package leaflet or contact their
Croatian: Praktične informacije o korištenju lijeka Vitekta pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For further information, see
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: For the full list of all side effects reported with Vitekta, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vitekta potražite u uputi o lijeku.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Vitekta vrijedi na prostoru Europske unije od 13.11.2013.
English: It is important to tell your doctor if you have:
Croatian: Važno je da obavijestite Vašeg liječnika ako imate:
English: If necessary you may receive additional salts.
Croatian: Možete primiti dodatne soli ako je potrebno.
English: Other available treatment options should be considered.
Croatian: Treba razmotriti druge dostupne oblike liječenja.
English: In addition it will be ensured that you receive enough fluids.
Croatian: Dodatno, biti će osigurano da primite dovoljno tekućine.
English: The lowest possible effective dose should be applied.
Croatian: Treba primijeniti najnižu moguću učinkovitu dozu.
English: The maximum recommended daily dose must not be exceeded.
Croatian: Ne smije se prekoračiti preporučena maksimalna dnevna doza.
English: The maximum daily dose is <30ml/kg for 6% HES (130/0.40) and 6% HES (130/0.42); for other HES products the maximum daily dose should be recalculated accordingly>.
Croatian: Maksimalna dnevna doza iznosi ˂30 ml/kg za 6% HES (130/0,40) i 6% HES (130/0,42); za ostale HES lijekove maksimalnu dnevnu dozu treba odgovarajuće preračunati>.
English: Your doctor will decide on the correct dose for you to receive.
Croatian: Vaš liječnik će odrediti točnu dozu koju ćete primati.
English: • have received an organ transplant
Croatian: • ste primili transplantirani organ
English: Your doctor will use the lowest possible effective dose and will not infuse <Product name> for more than 24 hours.
Croatian: Liječnik će upotrijebiti najmanju moguću učinkovitu dozu i neće infundirati ˂Ime lijeka> više od 24 sata.
English: • are allergic to any of the active substances or any of the other ingredients of this medicine
Croatian: • ste alergični na bilo koju djelatnu tvar ili bilo koji drugi sastojak ovog lijeka
English: • have too much fluid in your body and you have been told that you have a condition known as hyperhydration
Croatian: • tijelo zadržava previše tekućine, i rečeno Vam je da ste u stanju poznatom kao hiperhidracija
English: Do not use <Product name> if you:
Croatian: Nemojte uzimati ˂Ime lijeka> ako:
English: The expected benefit of treatment should be carefully weighed against uncertainty with regard to this long term safety.
Croatian: Očekivanu korist liječenja treba pažljivo odvagati u odnosu na neizvjesnost dugoročne sigurnosti primjene.
English: What you need to know before you use <Product name>
Croatian: Što trebate znati prije primjene ˂Ime lijeka>
English: The product information shall be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacija o lijeku može biti naknadno obnovljena od nadležnog tijela države članice, vezano za referalnu državu članicu, koja je odgovorna, u skladu s postupkom određenim u Poglavlju 4 Dijela III Direktive 2001/83/EC.
English: • are critically ill (e.g. you need to stay in an intensive care unit)
Croatian: • ste u kritičnom stanju (tj. trebate ostati na odjelu intenzivne njege)
English: • suffer from bleeding in the brain (intracranial or cerebral bleeding)
Croatian: • bolujete od krvarenja u mozgu (intrakranijalno ili cerebralno krvarenje)
English: In the case of repeated administration, blood coagulation parameters should be monitored carefully.
Croatian: U slučaju ponovljene primjene, treba pažljivo pratiti koagulacijske parametre krvi.
English: This will be done especially if you have problems with your lungs or with your heart or circulation.
Croatian: Ovo će se posebno učiniti ako imate probleme sa plućima, srcem ili cirkulacijom.
English: Section 4.3 Contraindications
Croatian: Dio 4.3 Kontraindikacije
English: Use of HES should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h.
Croatian: Primjenu HES-a treba ograničiti na početnu fazu nadomještanja volumena s maksimalnim vremenskim trajanjem do 24 sata.
English: Surgery and trauma: Your doctor will consider carefully if this medicine is suitable for you.
Croatian: Operacija i ozljeda: Vaš će liječnik pažljivo procijeniti odgovara li Vam ovaj lijek.
English: Your doctor will adjust the dose of <Product name> carefully in order to prevent fluid overload.
Croatian: Vaš liječnik će pažljivo prilagoditi dozu ˂Ime lijeka> kako bi se spriječilo preopterećenje suviškom tekućine.