FrancophonIA/ELRC3.0 huggingface dataset:
English: Because C1 inhibitor is an endogenous human plasma protein, it is not subject to metabolism by Cytochrome P450 iso-enzymes, excretion, or pharmacokinetic drug-drug interactions exhibited by many low molecular weight compounds.
Croatian: Budući da je inhibitor C1 endogeni protein u ljudskoj plazmi, ne metaboliziraju ga izoenzimi citokroma P450, ne izlučuje se i ne ulazi u farmakokinetičke interakcije s lijekovima, kao što se događa s mnogim spojevima niske molekularne težine.
English: Note: the transfer device must be attached to the solvent vial before being attached to the powder vial, so that the vacuum in the powder vial is not lost.
Croatian: Napomena: naprava za prijenos mora biti spojena s bočicom s otapalom prije nego što se spoji s bočicom s praškom, tako da se ne izgubi vakuum u bočici s praškom.
English: Do not remove the clear end of the transfer device from the powder vial.
Croatian: Nemojte ukloniti prozirni kraj naprave za prijenos iz bočice s praškom.
English: Remove plastic caps from the powder and solvent vials.
Croatian: Uklonite plastične poklopce s bočica s praškom i otapalom.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere za sprječavanje infekcija koje nastaju zbog primjene lijekova proizvedenih iz ljudske krvi ili plazme uključuju odabir darivatelja, probir krvi pojedinog darivatelja i prikupljene plazme na određene biljege infekcije i uključenje koraka za učinkovitu inaktivaciju/uklanjanje virusa tijekom proizvodnje.
English: • Additional risk minimisation measures Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Croatian: Prije stavljanja lijeka u promet u svakoj pojedinoj zemlji članici nositelj odobrenja za stavljanje lijeka u promet dogovorit će sadržaj i oblik edukacijskog materijala s nadležnim nacionalnim tijelom.
English: The educational material for healthcare professionals should include information on the following key elements:
Croatian: Edukacijski materijal za zdravstvene radnike treba uključivati informacije o sljedećim ključnim elementima:
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Croatian: Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom, kao što su virus humane imunodeficijencije (HIV) i virusi hepatitisa B i C te za viruse bez ovojnice hepatitisa A i parvovirusa B19.
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Croatian: Mjere koje se poduzimaju smatraju se učinkovitima za viruse s ovojnicom kao što su HIV, HBV i HCV te za viruse bez ovojnice HAV i parvovirus B19.
English: There is limited information on the safety of Cinryze use during pregnancy and breast-feeding.
Croatian: Podaci o sigurnosti primjene lijeka Cinryze tijekom trudnoće i dojenja su ograničeni.
English: For safety with respect to transmissible agents, see section 4.4.
Croatian: Za sigurnost s obzirom na infektivne uzročnike, vidjeti dio 4.4.
English: After intravenous administration of a single dose of Cinryze to HAE subjects, the serum concentration of functional C1 inhibitor doubled within 1 to 2 hours.
Croatian: Nakon intravenske primjene jedne doze lijeka Cinryze ispitanicima s HAE, koncentracije funkcionalnog inhibitora C1 u serumu udvostručile su se u roku od 1 do 2 sata.
English: Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.
Croatian: Rutinska prevencija napadaja angioedema u odraslih, adolescenata i djece (u dobi od 6 godina i starije) s teškim i ponavljajućim napadajima hereditarnog angioedema (HAE) koji ne podnose preventivno peroralno liječenje ili im ono ne pruža dovoljnu zaštitu ili u bolesnika koje se ne može primjereno zbrinuti ponavljanjem akutnog liječenja.
English: Educational material for healthcare professionals
Croatian: Edukacijski materijal za zdravstvene radnike.
English: Cinryze therapy should be initiated under supervision of a physician experienced in the care of patients with hereditary angioedema (HAE).
Croatian: Terapiju lijekom Cinryze treba započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika s hereditarnim angioedemom (HAE).
English: Among these children, the only adverse reactions with Cinryze included headache, nausea, pyrexia, and infusion site erythema.
Croatian: Među tom su djecom jedine nuspojave uz Cinryze uključivale glavobolju, mučninu, pireksiju i eritem na mjestu infuzije.
English: It is unknown whether C1 inhibitor is excreted in human milk.
Croatian: Nije poznato izlučuje li se inhibitor C1 u majčino mlijeko.
English: The subjects received either a single intravenous dose of 1000 Units or a 1000 Units dose followed by a second dose of 1000 Units
Croatian: Ispitanici su primili jednu intravensku dozu od 1000 jedinica ili prvo jednu dozu od 1000 jedinica pa drugu dozu od 1000 jedinica
English: In open-label study LEVP 2006-1, 101 subjects were treated for a total of 609 acute HAE attacks (median 3 attacks per subject; range: 1-57).
Croatian: U otvorenom ispitivanju LEVP 2006-1 liječen je 101 ispitanik zbog ukupno 609 akutnih napadaja HAE (medijan od 3 napadaja po ispitaniku; raspon: 1-57).
English: C1 inhibitor inhibits the complement system by binding C1r and C1s, two of the active enzyme subunits of the first component of the complement system (C1) in the classical pathway, as well as to mannose-binding lectin-associated serine proteases in the lectin pathway.
Croatian: Inhibitor C1 inhibira sustav komplementa tako što se veže za C1r i C1s, dvije aktivne enzimske podjedinice prve komponente sustava komplementa (C1) na klasičnom putu, kao i za serinske proteaze povezane s lektinom koje vežu manozu na lektinskom putu.
English: Prevention of swelling attacks prior to surgery
Croatian: Sprječavanje naglog oticanja prije kirurškog zahvata
English: Do not use Cinryze after the expiry date which is stated on the carton or vials after “EXP”.
Croatian: Cinryze se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili bočicama iza “Rok valjanosti”.
English: Cinryze for the pre-procedure prevention of HAE attacks Open-label Cinryze was administered within 24 hours prior to a total of 91 medical, dental, or surgical procedures across the clinical programme (40 procedures in children and 51 procedures in adults).
Croatian: Cinryze za prevenciju napadaja hereditarnog angioedema (HAE) prije zahvata Cinryze se na otvoren način primijenio u roku od 24 sata prije ukupno 91 medicinskog, stomatološkog i kirurškog zahvata u kliničkom programu (40 zahvata u djece i 51 zahvat u odraslih).
English: Do not remove the device from the package.
Croatian: Nemojte vaditi napravu iz pakiranja.
English: Inspect the reconstituted Cinryze solution for particulate matter prior to administration; do not use if particles are observed.
Croatian: Prije primjene pregledajte rekonstituiranu otopinu lijeka Cinryze da ne sadrži čestice; nemojte je primijeniti ako opazite čestice.
English: Necessary skills have to be acquired by non-healthcare professionals before Cinryze may be safely and effectively administered at home.
Croatian: Nezdravstveni radnici trebaju steći potrebne vještine prije nego što će moći sigurno i djelotvorno primjenjivati Cinryze kod kuće.
English: Each single-use powder vial contains 500 International Units (IU) of C1 inhibitor (human) produced from the plasma of human donors.
Croatian: Jedna bočica praška za jednokratnu uporabu sadrži 500 međunarodnih jedinica (IU) inhibitora C1 (ljudskog) proizvedenog iz plazme ljudskih darivatelja.
English: In open-label study LEVP 2006-4, 146 subjects received Cinryze as HAE prophylaxis for periods ranging from 8 days to approximately 32 months (median 8 months).
Croatian: U otvorenom ispitivanju LEVP 2006-4, 146 ispitanika primalo je Cinryze kao profilaksu protiv HAE u razdoblju od 8 dana do približno 32 mjeseca (medijan od 8 mjeseci).
English: Ensure the powder vial and the solvent vial are at room temperature (15ºC - 25ºC).
Croatian: Vodite računa da bočica s praškom i bočica s otapalom budu sobne temperature (15ºC - 25ºC).
English: Age-group <6years: For the 3 subjects less than 6 years, administration of Cinryze (500 Units or 1000 Units
Croatian: Dobna skupina <6 godina: U 3 ispitanika mlađih od 6 godina, primjena lijeka Cinryze (500 jedinica ili 1000 jedinica
English: Overall administration of Cinryze was well tolerated.
Croatian: Sveukupno, primjena lijeka Cinryze dobro se podnosila.
English: Study LEVP 2006-4: Prior to enrollment, 23 children (age range: 3 to 17 years) reported a median monthly HAE attack rate of 3.0 (range: 0.5-28.0).
Croatian: Ispitivanje LEVP 2006-4: Prije uključenja, u 23 djece (raspon dobi: 3-17 godina) zabilježen je medijan stope mjesečnih napadaja HAE od 3,0 (raspon: 0,5-28,0).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti nuspojave su prikazane slijedom prema opadajućoj ozbiljnosti.
English: The active substance is C1 inhibitor produced from the plasma of human donors.
Croatian: Djelatna tvar je inhibitor C1 proizveden iz plazme ljudskih darivatelja.
English: C1 inhibitor is a member of the serine protease inhibitor, or serpin, superfamily of proteins.
Croatian: Inhibitor C1 pripada nadobitelji proteina inhibitora serinske proteaze ili serpina.
English: Low serum C4 levels often correlate with HAE attacks.
Croatian: Niske razine C4 u serumu često koreliraju s napadajima hereditarnog angioedema.
English: Administration of C1 inhibitor increases serum levels of C1 inhibitor activity and temporarily restores the natural regulation of the contact, complement, and fibrinolytic systems thereby controlling the swelling or the propensity to swell.
Croatian: Primjena inhibitora C1 povećava razinu aktivnosti inhibitora C1 u serumu i privremeno obnavlja prirodnu regulaciju sustava kontakta, komplementa i fibrinolize te tako kontrolira oticanje ili sklonost oticanju.
English: Adverse reaction frequencies were estimated from 2 pivotal placebo-controlled and 2 open-label studies in 251 unique subjects.
Croatian: Učestalosti nuspojava bile su procijenjene na temelju dvaju pivotalnih placebom kontroliranih i dvaju otvorenih ispitivanja provedenih u 251 jedinstvenog ispitanika.
English: Prior to enrollment, subjects reported a median monthly HAE attack rate of 3.0 (range: 0.08-28.0); during therapy with prophylactic Cinryze, this rate was 0.21 (range: 0-4.56), and 86% of subjects experienced an average of ≤1 attack per month.
Croatian: Prije uključenja ispitanici su prijavili medijan mjesečne stope napadaja HAE od 3,0 (raspon: 0,08-28,0); tijekom profilaktičke terapije lijekom Cinryze ova je stopa bila 0,21 (raspon: 0-4,56), a 86% ispitanika imalo je prosječno ≤1 napadaja mjesečno.
English: You will be required to keep a diary in order to document each treatment received at home and to bring it to each of your visits to the doctor.
Croatian: Od Vas će se zahtijevati da vodite dnevnik u koji ćete zapisati svako liječenje koje ste primili kod kuće i koji ćete donositi sa sobom na svaki pregled kod liječnika.
English: Age-Group 6-11 years:
Croatian: Dobna skupina od 6 do 11 godina:
English: Each product vial should be reconstituted with 5 ml water for injections.
Croatian: Jednu bočicu lijeka treba rekonstituirati s 5 ml vode za injekcije.
English: Aseptic technique should be used during the reconstitution procedure.
Croatian: Tijekom postupka rekonstitucije potrebno je koristiti aseptičku tehniku.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Croatian: Bolesnike treba obavijestiti o ranim znakovima reakcija preosjetljivosti koje uključuju koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje u plućima, hipotenziju i anafilaksiju.
English: Cinryze has minor influence on the ability to drive and use machines.
Croatian: Cinryze malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Each kit contains material for either one 1000 IU dose or two 500 IU doses.
Croatian: Jedan komplet sadrži materijal za jednu dozu od 1000 IU ili za dvije doze od 500 IU.
English: Solvent for Cinryze Water for injections
Croatian: Otapalo za Cinryze Voda za injekcije
English: Using a sterile, disposable 10 ml syringe, draw back the plunger to allow approximately 5 ml of air into the syringe.
Croatian: Uzmite sterilnu štrcaljku od 10 ml za jednokratnu uporabu i izvucite klip tako da u štrcaljku uđe približno 5 ml zraka.
English: Uncommon side effects (may affect up to 1 in 100 people): high blood sugar, blood clot, painful veins, hot flush, cough, stomach pain, diarrhoea, skin flaking, joint swelling and pain, muscle pain, and chest discomfort.
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): povišen šećer u krvi, krvni ugrušak, bolne vene, navale vrućine, kašalj, bol u trbuhu, proljev, perutanje, oticanje zglobova i bol u zglobovima, bol u mišićima i nelagoda u prsnom košu.
English: • If you are experiencing a severe attack, particularly a swelling of the voice-box (larynx), or if initiation of treatment is delayed, the second 1000 IU dose may be given earlier than 60 minutes after the first dose, depending on your clinical response.
Croatian: • Ako dobijete težak napadaj, osobito oticanje grkljana (larinksa), ili se kasni s početkom liječenja, druga doza od 1000 IU može se dati prije nego protekne 60 minuta od prve doze,
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Usprkos tome, kad se primjenjuju lijekovi pripremljeni iz ljudske krvi ili plazme, mogućnost prenošenja infektivnih uzročnika ne može se potpuno isključiti.
English: • For patients experiencing laryngeal attacks or if initiation of treatment is delayed, the second dose can be given sooner than 60 minutes.
Croatian: • Za bolesnike koji imaju laringealne napadaje ili ako se kasnije započelo s liječenjem, druga se doza može dati i prije nego što je proteklo 60 minuta.
English: For subjects receiving Cinryze prophylaxis for at least 1 year, the monthly attack rate per subject remained consistently low (0.34 attacks per month) relative to pre-study rates.
Croatian: Za ispitanike koji su primali profilaksu lijekom Cinryze najmanje 1 godinu mjesečna stopa napadaja po ispitaniku ostala je dosljedno niska (0,34 napadaja mjesečno) u odnosu na stope prije ispitivanja.
English: Adverse reactions to treatment with Cinryze are classified by MedDRA System Organ Class and absolute frequency in Table 1.
Croatian: Nuspojave na liječenje lijekom Cinryze klasificirane su prema MedDRA klasifikaciji organskih sustava i apsolutnoj učestalosti u tablici 1.
English: In all studies, administration of Cinryze resulted in increases in antigenic and functional C1 inhibitor levels post-infusion compared to pre-infusion values in both children and adults.
Croatian: U svim ispitivanjima primjena lijeka Cinryze dovela je do povišenja razine antigene i funkcionalne aktivnosti inhibitora C1 nakon infuzije u usporedbi s vrijednostima prije infuzije, kako u djece tako i u odraslih.
English: Cinryze is intended for intravenous administration after reconstitution with water for injections.
Croatian: Cinryze je namijenjen za intravensku primjenu nakon rekonstitucije s vodom za injekcije.
English: Among 15 subjects treated with open-label Cinryze for laryngeal HAE attacks, none required intubation.
Croatian: ispitanika otvoreno liječenih lijekom Cinryze zbog laringealnog napadaja HAE ni u jednog nije bila potrebna intubacija.
English: In addition, fewer open-label Cinryze infusions were required for treatment of HAE attacks during therapy with Cinryze compared to placebo (mean 4.7 infusions vs. 15.4 infusions or 70% reduction, p<0.0001).
Croatian: Osim toga, bilo je potrebno manje otvoreno primijenjenih infuzija lijeka Cinryze za liječenje napadaja HAE tijekom terapije lijekom Cinryze u usporedbi s placebom (srednji broj infuzija 4,7 naspram 15,4 infuzija ili smanjenje za 70%, p<0,0001).
English: The percentage of subjects with beginning of unequivocal relief of the defining symptom within 4 hours after dosing was 60% for Cinryze and 42% for placebo (p=0.062).
Croatian: Postotak ispitanika u kojih je vidljivo povlačenje glavnog simptoma počelo unutar 4 sata nakon primjene doze iznosio je 60% za Cinryze i 42% za placebo (p=0,062).
English: Therefore two vials are combined for one dose of 1000 IU.
Croatian: Zato se dvije bočice spajaju za jednu dozu od 1000 IU.
English: The dosing interval and dose may need to be adjusted according to individual response.
Croatian: Možda će trebati prilagoditi interval doziranja i dozu ovisno o odgovoru pojedinog bolesnika.
English: Reconstitution, product administration and handling of the administration set and needles must be done with caution.
Croatian: Rekonstitucija, primjena lijeka i rukovanje setom za primjenu i iglama mora se provesti s oprezom.
English: The proportion of HAE attacks achieving unequivocal relief of the defining symptom within 4 hours after Cinryze treatment was comparable between the 22 children enrolled (age range: 2-17) and adults, with 89% and 86% of attacks achieving relief, respectively.
Croatian: Udio napadaja HAE kod kojih se postiglo vidljivo povlačenje glavnog simptoma u roku od 4 sata nakon liječenja lijekom Cinryze bio je usporediv između 22 uključene djece (raspon dobi: 2-17) i odraslih, s time da se povlačenje simptoma postiglo u 89% odnosno 86% napadaja.
English: Adverse reactions reported in clinical studies and in postmarketing reports
Croatian: Tablica 1. Nuspojave zabilježene u kliničkim ispitivanjima i izvješćima nakon stavljanja lijeka u promet
English: Your treatment will be initiated and managed under supervision of a doctor experienced in the care of patients with hereditary angioedema (HAE).
Croatian: Liječenje će započeti i provodit će se pod nadzorom liječnika s iskustvom u skrbi za bolesnike s hereditarnim angioedemom.
English: It is strongly recommended that every time Cinryze is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Croatian: Izrazito se preporučuje svaki put kad se Cinryze primjenjuje bolesniku zapisati naziv i broj serije lijeka kako bi se osigurala poveznica između bolesnika i serije lijeka.
English: It is the responsibility of the prescribing physician to provide appropriate training to the nonhealthcare professional who will administer the treatment at home, such as the patient for selfadministration or a family member.
Croatian: Odgovornost je liječnika koji propisuje lijek da osigura odgovarajuću obuku za nezdravstvene radnike koji će primjenjivati liječenje kod kuće, kao što je obuka bolesnika u samoprimjeni ili obuka člana obitelji.
English: Administration process for a dose of 1000 IU
Croatian: Postupak primjene za dozu od 1000 IU
English: Administration process for a dose of 500 IU
Croatian: Postupak primjene za dozu od 500 IU
English: In clinical studies, the intravenous administration of Cinryze resulted in a significant increase in systemic levels of antigenic and functional C1 inhibitor within 1 hour after administration.
Croatian: U kliničkim ispitivanjima, intravenska primjena lijeka Cinryze dovela je do značajnog povećanja sistemskih razina antigene i funkcionalne aktivnosti inhibitora C1 unutar 1 sata nakon primjene.
English: For treatment, routine prevention and pre-procedure prevention in adolescents 12 to 17 years old, the dose is the same as for adults.
Croatian: Za liječenje, rutinsku prevenciju i prevenciju prije zahvata kod adolescenata u dobi od 12 do 17 godina doza je ista kao i kod odraslih.
English: System Organ Class
Croatian: Klasa organskog sustava Učestalost
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived C1 inhibitor product.
Croatian: Odgovarajuće cijepljenje (hepatitis A i B) potrebno je razmotriti u bolesnika koji redovito/ponovno primaju lijek s inhibitorom C1 iz ljudske plazme.
English: Each vial of Cinryze contains approximately 11.5 mg of sodium.
Croatian: Jedna bočica lijeka Cinryze sadrži približno 11,5 mg natrija.
English: Cinryze is intended for intravenous administration (into the vein) after reconstitution with water for injections.
Croatian: Cinryze je namijenjen za intravensku primjenu (u venu) nakon rekonstitucije s vodom za injekcije.
English: It is the responsibility of the prescribing physician to verify that all the necessary skills have been acquired by the non-healthcare professional and that Cinryze may be safely and effectively administered at home.
Croatian: Odgovornost je liječnika koji propisuje lijek da provjeri je li nezdravstveni radnik usvojio sve potrebne vještine i da se Cinryze može sigurno i djelotvorno primjenjivati kod kuće.
English: How to take Cinryze
Croatian: Kako uzimati Cinryze
English: There are limited data on the use of this medicinal product in home or self-administration.
Croatian: Postoje ograničeni podaci o primjeni ovog lijeka kod kuće i o samoprimjeni.
English: Study 0624-301: Six pediatric subjects (6 to 11 years of age ) were enrolled and randomized to twice weekly dosing for 12 weeks in 2 treatment sequences (500/1000 Units or 1000/500 Units
Croatian: Ispitivanje 0624-301: šest pedijatrijskih ispitanika (u dobi od 6 do 11 godina) bilo je uključeno i randomizirano za doziranje dvaput tjedno u trajanju od 12 tjedana u 2 sekvence liječenja (500/1000 jedinica() ili 1000/500 jedinica() lijeka Cinryze.
English: The total number of days of swelling during prophylactic Cinryze therapy was reduced compared to placebo (mean 10.1 days vs. 29.6 days or a 66% reduction, p<0.0001).
Croatian: Bio je smanjen ukupni broj dana oticanja tijekom profilaktičke terapije lijekom Cinryze u usporedbi s placebom (srednji broj dana 10,1 naspram 29,6 dana ili smanjenje za 66%, p<0,0001).
English: Invert the vial gently and inject air into the solution and then slowly withdraw the reconstituted Cinryze solution into the syringe.
Croatian: Nježno okrenite bočicu naopako i ubrizgajte zrak u otopinu, a potom polako uvucite rekonstituiranu otopinu lijeka Cinryze u štrcaljku.
English: In adults and children, Cinryze can raise the amount of C1 inhibitor in the blood and either prevent (prior to undergoing medical or dental procedures) these swelling attacks from occurring or stop swelling attacks once they have begun.
Croatian: Cinryze može povećati količinu inhibitora C1 u krvi u odraslih i djece i spriječiti (prije medicinskih ili zubarskih zahvata) pojavu novih oteklina ili zaustaviti razvoj oteklina nakon što su se pojavile.
English: Data on a limited number of exposed pregnancies indicate no adverse effects of C1 inhibitor on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available.
Croatian: Ograničeni podaci u izloženih trudnica pokazuju da inhibitor C1 nema štetnih učinaka na trudnoću ili zdravlje fetusa/novorođenčeta.