FrancophonIA/ELRC3.0 huggingface dataset:
English: A doctor or nurse may prepare and inject Cinryze for you.
Croatian: Liječnik ili medicinska sestra mogu Vam pripremiti i ubrizgati Cinryze.
English: Symptoms may include stomach pains and swelling of the:
Croatian: Simptomi mogu uključivati bolove u trbuhu i otekline:
English: If there is no vacuum in the vial, do not use the product.
Croatian: Ako u bočici nema vakuuma, nemojte uporabiti taj lijek.
English: Data collected in this registry should be reported to the CHMP at the time of PSUR submissions.
Croatian: Podatke prikupljene u ovom registru treba prijaviti CHMP-u istovremeno s podnošenjem PSUR-a.
English: Overall, the safety and tolerability of Cinryze are similar in children, adolescents and adults.
Croatian: Općenito su sigurnost i podnošljivost lijeka Cinryze slični u djece, adolescenata i odraslih.
English: Cinryze is not for use in children below 6 years of age for routine prevention of angioedema attacks.
Croatian: Cinryze nije za primjenu u djece ispod 6 godina starosti za rutinsku prevenciju napadaja angioedema.
English: C1 inhibitor is a naturally occurring protein that is normally present in the blood.
Croatian: Inhibitor C1 je prirodan protein koji se normalno nalazi u krvi.
English: The total protein content of the reconstituted solution is 15 ± 5 mg/ml.
Croatian: Ukupni sadržaj proteina u rekonstituiranoj otopini je 15 ± 5 mg/ml.
English: The continued need for regular prophylaxis with Cinryze should be reviewed on a regular basis.
Croatian: Trajnu potrebu za redovitom profilaksom lijekom Cinryze treba redovito provjeravati.
English: Do not reuse the transfer device.
Croatian: Nemojte ponovno uporabiti istu napravu za prijenos.
English: Elimination half-life (hr)
Croatian: Poluvijek eliminacije (hr)
English: A post-marketing registry should be set-up with the objective to gain additional information on the safety and the use of Cinryze in the EU.
Croatian: Potrebno je uspostaviti registar za razdoblje nakon stavljanja lijeka u promet s ciljem da se dobiju dodatne informacije o sigurnosti i primjeni lijeka Cinryze u EU.
English: The primary substrate of the activated C1 enzyme is C4; uninhibited C1 results in diminished C4 levels.
Croatian: Primarni supstrat aktiviranog enzima C1 je C4; neinhibirani C1 dovodi do sniženja razine C4.
English: The Marketing Authorisation Holder (MAH) should ensure that all healthcare professionals who are expected to prescribe Cinryze are provided with an Educational pack.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet treba osigurati da svi zdravstveni radnici za koje se očekuje da će propisivati Cinryze dobiju edukacijski paket.
English: Side effects in children and adolescents are expected to be similar to those in adults.
Croatian: Očekuje se da će nuspojave u djece i adolescenata biti slične onima u odraslih bolesnika.
English: Use either the filter transfer device provided with Cinryze or a commercially available double-ended needle.
Croatian: Uporabite napravu za prijenos s filtrom priloženu uz Cinryze ili komercijalno dostupnu dvostranu iglu.
English: No genotoxicity studies were performed as the active substance is unlikely to interact directly with DNA or other chromosomal material.
Croatian: Nisu provedena ispitivanja genotoksičnosti budući da djelatna tvar najvjerojatnije neće ući u izravnu interakciju s DNK ili drugim kromosomskim materijalom.
English: Work on the mat provided and wash your hands before performing the following procedures.
Croatian: Radite na priloženoj podlozi i operite ruke prije provođenja sljedećih postupaka.
English: Particular attention should be given to the monitoring of cases of severe and laryngeal attacks as well as cases where treatment started later than 4 hours after onset of attack; details about the administered dose, timing of dosing, safety and efficacy outcome should be reported.
Croatian: Osobitu pozornost treba dati praćenju slučajeva teških i laringealnih napadaja, kao i slučajevima gdje je liječenje započelo više od 4 sata nakon početka napadaja; potrebno je zabilježiti i detalje o primijenjenoj dozi, vremenu primjene doze, sigurnosti te ishodu djelotvornosti.
English: 6 to 11 years:
Croatian: Od 6 do 11 godina:
English: Very common side effects (may affect more than 1 in 10 people): headache, nausea.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): glavobolja, mučnina.
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se također odnosi na sve nepoznate ili novonastale viruse i druge vrste infekcija.
English: Functional C1 inhibitor activity was measured in children in the two open label studies (see section 5.1).
Croatian: Funkcionalna aktivnost inhibitora C1 mjerena je u djece u dva otvorena ispitivanja (vidjeti dio 5.1).
English: If you have a low amount of C1 inhibitor in your blood or your C1 inhibitor is not working properly, this can lead to swelling attacks (called angioedema).
Croatian: Ako imate malu količinu inhibitora C1 u krvi ili Vam inhibitor C1 ne funkcionira ispravno, to može dovesti do iznenadne pojave oteklina (nazvanih angioedem).
English: Store the remaining vial and administration equipments for the next dose.
Croatian: Čuvajte preostalu bočicu i opremu za primjenu za sljedeću dozu.
English: Thrombotic events
Croatian: Trombotički događaji
English: subjects (>25 kg) 1500 Units
Croatian: , a 3 ispitanika (>25 kg) 1500 jedinica
English: dental, or surgical procedure.
Croatian: zubarskog ili kirurškog zahvata.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Croatian: Proizvođači ovih lijekova također primjenjuju korake u obradi krvi ili plazme kojima se inaktiviraju ili uklanjaju virusi.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi i na nepoznate ili novonastale viruse i druge patogene.
English: 2 to 11 years, >25 kg:
Croatian: Od 2 do 11 godina, >25 kg:
English: Further information to be collected includes data on drug exposure, adverse drug reactions, frequency of attacks, long-term safety data, use in pregnant patients with outcome of pregnancies, as well as use in the paediatric population.
Croatian: Dodatne informacije koje treba prikupiti uključuju podatke o izloženosti lijeku, nuspojave, učestalost napadaja, podatke o dugotrajnoj sigurnosti, primjeni u trudnica s ishodom trudnoća, kao i primjeni u pedijatrijskoj populaciji.
English: The recommended dose of Cinryze for adults, adolescents, children, the elderly, or patients suffering from kidney or liver problems is as follows:
Croatian: Preporučena doza lijeka Cinryze za odrasle, adolescente, djecu, starije ili bolesnike koji imaju tegobe s bubrezima ili jetrom je sljedeća:
English: What Cinryze contains
Croatian: Što Cinryze sadrži
English: Pharmacotherapeutic group: Drugs used in hereditary angioedema, C1 inhibitor, plasma derived, ATC code: B06AC01.
Croatian: Farmakoterapijska skupina: lijekovi koji se primjenjuju kod hereditarnog angioedema, inhibitor C1, dobiven iz plazme, ATK oznaka: B06AC01.
English: For 98% of procedures, no HAE attacks were reported within the 72 hours after the Cinryze dose.
Croatian: Kod 98% zahvata nije bio prijavljen nijedan napadaj HAE unutar 72 sata nakon primjene doze lijeka Cinryze.
English: Do not take Cinryze
Croatian: Nemojte uzimati Cinryze
English: No maternal or embryofoetal effects of treatment were observed in reproductive studies in rats at dose levels up to 28-times the recommended human dose (1000 IU) based on an average adult body weight of 70 kg.
Croatian: Nisu opaženi učinci na majku ili embrije/fetuse u reproduktivnim ispitivanjima na štakorima pri razinama doza do 28 puta višima od preporučene doze u ljudi (1000 IU) na temelju prosječne tjelesne težine odrasle osobe od 70 kg.
English: The very common adverse reactions observed following Cinryze infusion in clinical studies were headache and nausea.
Croatian: Vrlo česte nuspojave opažene nakon infuzije lijeka Cinryze u kliničkim ispitivanjima bile su glavobolja i mučnina.
English: For subjects with >1 attack, the proportion of attacks responding within 4 hours after Cinryze dosing and the time to response was comparable regardless of the number of attacks treated.
Croatian: Kod ispitanika s >1 napadajem udio napadaja koji su odgovorili u roku od 4 sata nakon primjene doze lijeka Cinryze i vrijeme do odgovora bilo je usporedivo bez obzira na broj liječenih napadaja.
English: Batch number and dose received
Croatian: Broj serije i primljene doze
English: Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
Croatian: Iznenadno piskanje pri disanju, otežano disanje, oticanje vjeđa, lica ili usana, osip ili svrbež (osobito koji zahvaća cijelo tijelo).
English: 2 to 11 years, 10-25 kg:
Croatian: 2 do 11godina, 10-25 kg:
English: Method and rate of administration of one dose of Cinryze (500 IU) Method and rate of administration of one dose of Cinryze (1000 IU) Instruction to seek emergency treatment by health care professionals in case of failure to gain venous access or in case of lack of efficacy
Croatian: Način i brzina primjene jedne doze lijeka Cinryze (500 IU) Način i brzina primjene jedne doze lijeka Cinryze (1000 IU) Upute za traženje hitnog liječenja od zdravstvenih radnika u slučaju neuspješnog pristupanja veni ili u slučaju izostanka djelotvornosti
English: In clinical studies local reactions (described as pain, bruising, or rash at the injection/catheter site, venous burning or phlebitis) occurred in association with approximately 0.2% of infusions.
Croatian: U kliničkim ispitivanjima lokalne reakcije (opisane kao bol, modrica ili osip na mjestu injekcije/katetera, žarenje vene ili flebitis) nastale su kod približno 0,2% infuzija.
English: The expected consequence of metabolism of a glycoprotein is via degradation to small peptides and individual amino acids.
Croatian: Očekivana posljedica metabolizma glikoproteina odvija se putem razgradnje do malih peptida i pojedinih aminokiselina.
English: No specific studies on fertility, early embryonic and postnatal development, or carcinogenicity studies were conducted (see section 5.3).
Croatian: Nisu provedena posebna ispitivanja učinaka na plodnost, rani embrionalni razvoj i postnatalni razvoj, kao niti ispitivanja kancerogenosti (vidjeti dio 5.3).
English: Treatment with Cinryze resulted in elevation of C4 levels at 12 hours.
Croatian: Liječenje lijekom Cinryze dovelo je do povišenja razine C4 nakon 12 sati.
English: ) was associated with increases in C1 INH levels and clinical efficacy in acute treatment and prevention of attacks.
Croatian: (*)) bila je povezana s povećanjem razina inhibitora C1 (C1 INH) i kliničkom djelotvornosti u akutnom liječenju i prevenciji napadaja.
English: All 9 (100%) subjects achieved unequivocal beginning of relief of the defining symptom within 4 hours following initiation of treatment with Cinryze.
Croatian: Svih 9 (100%) ispitanika postiglo je vidljiv početak povlačenja glavnog simptoma u roku od 4 sata nakon početka liječenja lijekom Cinryze.
English: Regular review of the administration by the patient/carer needs to be performed to ensure maintenance of optimal practice.
Croatian: Potrebno je redovito provjeravati primjenu koju provodi bolesnik/skrbnik kako bi se osiguralo održavanje optimalne prakse.
English: A leaflet providing detailed information on the key elements of the training that should be kept at home for further reference.
Croatian: Uputu s detaljnim informacijama o ključnim elementima obuke potrebno je čuvati kod kuće za daljnju uporabu.
English: Cinryze is a white powder contained in a vial.
Croatian: Cinryze je bijeli prašak u bočici.
English: Very common headache Common
Croatian: Vrlo često glavobolja
English: No studies on fertility, early embryonic and post-natal development, or carcinogenicity studies were conducted because chronic dosing in animals would be expected to be associated with development of neutralising antibodies to the human protein.
Croatian: Nisu provedena ispitivanja učinaka na plodnost, rani embrionalni i postnatalni razvoj, kao niti ispitivanja kancerogenosti, jer se očekuje da bi kronična primjena u životinja bila povezana s razvojem neutralizirajućih protutijela na ovaj ljudski protein.
English: • Cinryze should be injected intravenously (into the vein).
Croatian: • Cinryze treba ubrizgati intravenski (u venu).
English: • If you begin to suffer from rashes, tightness of the chest, wheezing, or a fast heart beat once you have taken Cinryze, you should tell your doctor immediately (see section 4).
Croatian: • Ako dobijete osip, osjetite stezanje u prsnom košu, imate piskanje pri disanju ili ubrzan rad srca nakon što uzmete Cinryze, odmah o tome obavijestite liječnika (pogledajte dio 4).
English: Based upon the clinical data currently available, Cinryze has minor influence on the ability to drive and use machines.
Croatian: Ne temelju trenutno dostupnih kliničkih podataka Cinryze malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Proceed to administration process if patients receive a dose of 500 IU.
Croatian: Prijeđite na postupak primjene ako bolesnik dobiva dozu od 500 IU.
English: Study LEVP 2006-1: Twenty-two paediatric subjects were treated for 121 acute HAE attacks.
Croatian: Ispitivanje LEVP 2006-1: dvadeset i dva pedijatrijska ispitanika liječeno je za 121 akutnih napadaja HAE.
English: Each pack of Cinryze contains:
Croatian: Jedno pakiranje lijeka Cinryze sadrži:
English: Cinryze is usually injected into a vein (intravenously) by your doctor or nurse.
Croatian: Cinryze će Vam obično ubrizgati u venu (intravenski) Vaš liječnik ili medicinska sestra.
English: tmax (hr) [median (range)]
Croatian: tmax (hr) [medijan (raspon)]
English: Because these pathways are part of enzyme amplification cascades, without C1 inhibitor, spontaneous or trigger-induced activation of these pathways can lead to unopposed activation and swelling.
Croatian: Budući da su ovi putevi dio kaskade aktivacije enzima i amplifikacije signala, bez inhibitora C1, spontana ili okidačem izazvana aktivacija ovih puteva može dovesti do nekontrolirane aktivacije i oticanja.
English: Double Dose (1000 Units dose followed by a second 1000 Units dose 60 minutes later)
Croatian: Dvostruka doza (prvo doza od 1000 jedinica te druga doza od 1000 jedinica 60 minuta kasnije)
English: Across clinical studies, there were 61 unique paediatric subjects enrolled and exposed to over 2,500 infusions of Cinryze (2-5 years, n=3; 6-11 years, n=32; 12-17 years, n=26).
Croatian: U kliničkim ispitivanjima bilo je uključeno 61 jedinstvenih pedijatrijskih ispitanika, koji su bili izloženi preko 2500 infuzija lijeka Cinryze (2-5 godina, n=3; 6-11 godina, n=32; 12-17 godina, n=26).
English: PSUR Cycle
Croatian: ciklus PSUR-a
English: Median interval was 0.5 hours (range: 0.25-2.5 hours): 1.25, 0.25, and 0.5 hours in the 500 Units(), 1000 Units(), and 1500 Units() Cinryze groups, respectively.
Croatian: Medijan razdoblja bio je 0,5 sati (raspon: 0,25-2,5 sata): 1,25; 0,25 i 0,5 sata u skupinama od 500 jedinica
English: After it has been dissolved in the water for injections the solution is clear and colourless to slightly blue.
Croatian: Nakon što se otopi u vodi za injekcije, otopina je bistra i bezbojna do blago plava.
English: Using the same syringe, repeat steps 3 to 6 with a second vial of reconstituted Cinryze to make one complete 10 ml dose.
Croatian: Pomoću iste štrcaljke ponovite korake br. 3 do 6 s drugom bočicom rekonstituiranog lijeka Cinryze kako biste pripremili jednu cijelu dozu od 10 ml.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti niže navedene mjere: Opis
English: Cleanse stoppers with a disinfection swab and allow them to dry prior to use.
Croatian: Očistite čepove vaticom za dezinfekciju i ostavite ih da se osuše prije uporabe.
English: C1 inhibitor is a single chain glycoprotein found in plasma which, in its mature state, consists of 478 amino acids with an apparent molecular weight of 105 kD.
Croatian: Inhibitor C1 jednolančani je glikoprotein koji se nalazi u plazmi i koji se, u svom zrelom obliku, sastoji od 478 aminokiselina s prividnom molekularnom težinom od 105 kD.
English: Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).
Croatian: Liječenje i prevencija napadaja angioedema prije zahvata u odraslih, adolescenata i djece (u dobi od 2 godina i starije) s hereditarnim angioedemom (HAE).
English: In adults, adolescents and children (aged 6 years and above), Cinryze can raise the amount of C1 inhibitor in the blood and routinely prevent swelling attacks from occurring.
Croatian: U odraslih, adolescenata i djece (u dobi od 6 godina i starije), Cinryze može povećati količinu inhibitora C1 u krvi i rutinski spriječiti pojavu razvoja oteklina.
English: Your doctor may recommend that you consider having vaccinations against hepatitis A and B if you regularly or repeatedly receive C1 inhibitor products that have been taken from human plasma.
Croatian: Liječnik Vam može preporučiti da razmislite o cijepljenju protiv hepatitisa A i B ako redovito ili ponovno primate lijekove s inhibitorom C1 koji je dobiven iz ljudske plazme.
English: Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity.
Croatian: Mogući rizici povezani s liječenjem kod kuće odnose se kako na samu primjenu, tako i na zbrinjavanje nuspojava, osobito preosjetljivosti.
English: As with any biological product hypersensitivity reactions may occur.
Croatian: Kao i sa svakim drugim biološkim lijekom mogu se razviti reakcije preosjetljivosti.
English: C1 is the most important inhibitor of contact activation and regulates the contact system and the intrinsic coagulation pathway by binding to and inactivating kallikrein and factor XIIa.
Croatian: C1 najvažniji je inhibitor kontaktne aktivacije i regulira sustav kontakta i intrinzički put koagulacije tako što se veže i inaktivira kalirein i faktor XIIa.
English: As such, the pharmacokinetics and excretion of Cinryze are not expected to be altered by renal or hepatic impairment.
Croatian: S obzirom na to, ne očekuje se da će farmakokinetika i izlučivanje lijeka Cinryze biti promijenjeni kod oštećenja funkcije bubrega ili jetre.
English: • When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Croatian: • Kad se lijekovi pripremaju od ljudske krvi ili plazme, primjenjuju se određene mjere kako bi se spriječio prijenos infekcija na bolesnike.
English: Your doctor will regularly review the preparation and administration process with you or a family member or carer.
Croatian: Liječnik će redovito s Vama, ili članom Vaše obitelji, ili skrbnikom provjeravati postupak pripreme i primjene.
English: Doses and Indications of treatment
Croatian: Doze i indikacije za liječenje
English: Therefore, repeat instructions 1 to 12 above using an additional package containing a transfer device to reconstitute the second of two powder vials.
Croatian: Stoga, ponovite gornje upute od 1 do 12 pomoću dodatnog pakiranja koje sadrži napravu za prijenos kako biste rekonstituirali drugu od dvije bočice s praškom.
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Croatian: Te mjere uključuju pažljiv odabir darivatelja krvi i plazme, kako bi se osiguralo da oni u kojih postoji rizik da nose infekciju budu isključeni, i provjeravanje svih donacija krvi i prikupljene plazme na znakove virusa/infekcija.
English: The vacuum in the powder vial will draw in the solvent.
Croatian: Vakuum u bočici s praškom uvući će otapalo.
English: The mean elimination half-life of functional C1 inhibitor after administration of Cinryze was 56 hours for a single dose and 62 hours for the double dose.
Croatian: Srednja vrijednost poluvijeka eliminacije funkcionalnog inhibitora C1 nakon primjene lijeka Cinryze iznosila je 56 sati za jednostruku dozu i 62 sata za dvostruku dozu.
English: Regular review of your/your carer's injection technique will be performed to ensure continued appropriate handling.
Croatian: Vaša tehnika davanja injekcije ili tehnika Vašeg skrbnika redovito će se provjeravati kako bi se osiguralo stalno ispravno rukovanje lijekom.
English: The existence of a post marketing registry in which health care professionals are encouraged to enter patients
Croatian: Postojanje registra nakon stavljanja lijeka u promet u koji se zdravstveni radnici potiču da unose podatke o bolesnicima.
English: Data from two randomised, double-blind, placebo-controlled studies (LEVP 2005-1/A and LEVP 2005-1/B), data from two open-label studies (LEVP 2006-1 and LEVP 2006-4) and 2 paediatric clinical studies (0624-203 and 0624-301) demonstrated the efficacy of Cinryze for the treatment and prevention of angioedema attacks in subjects with HAE.
Croatian: Podaci iz dvaju randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja (LEVP 2005-1/A i LEVP 2005-1/B), podaci iz dvaju otvorenih ispitivanja (LEVP 2006-1 i LEVP 2006-4) te 2 pedijatrijska klinička ispitivanja (0624-203 i 0624-301) pokazali su djelotvornost lijeka Cinryze u liječenju i sprječavanju napadaja angioedema u ispitanika s hereditarnim angioedemom (HAE).
English: There was a statistically significant (p=0.0017) difference in the changes in mean values from baseline between treatment groups at 12 hours, demonstrating the association of Cinryze treatment with an increase in C4 activity (Cinryze + 2.9 mg/dl versus placebo + 0.1 mg/dl).
Croatian: Postojala je statistički značajna (p=0,0017) razlika u promjeni srednjih vrijednosti od početnih između terapijskih skupina nakon 12 sati, što je pokazalo povezanost liječenja lijekom Cinryze s povećanjem aktivnosti C4 (Cinryze + 2,9 mg/dl naspram placebo + 0,1 mg/dl).
English: A randomised, parallel group, open-label pharmacokinetic study of Cinryze was performed in subjects with non-symptomatic HAE.
Croatian: Randomizirano, otvoreno farmakokinetičko ispitivanje lijeka Cinryze na usporednim skupinama provelo se u ispitanika s nesimptomatskim HAE.
English: Cinryze contains the human protein called “C1 inhibitor” as the active substance.
Croatian: Cinryze sadrži ljudski protein“inhibitor C1” kao djelatnu tvar.
English: After reconstitution, the product should be used immediately.
Croatian: Nakon rekonstitucije, lijek se mora odmah primijeniti.
English: Their prescribing physician will provide training on the following elements: Precaution for storage
Croatian: Njihov liječnik koji propisuje lijek osigurat će obuku u sljedećim elementima: Mjere opreza pri čuvanju lijeka
English: It is strongly recommended that every time you receive a dose of Cinryze the name and batch number of the product are recorded by your nurse or doctor in order to maintain a record for the batches used.
Croatian: Izrazito se preporučuje da svaki put kad primite dozu lijeka Cinryze, Vaša medicinska sestra ili liječnik zabilježe naziv i broj serije lijeka da bi se imao zapis o primijenjenim serijama.
English: Mean increases from baseline in functional C1 inhibitor activity measured 1 hour post-dose in children 2 to <18 years of age ranged from 20% to 88% in Study LEVP 2006-1 (treatment) and from 22% to 46% in Study LEVP 2006-4 (prevention) compared with 21% to 66% and 25% to 32% in adults, respectively.
Croatian: Srednja vrijednost povećanja u odnosu na početnu vrijednost funkcionalne aktivnosti inhibitora C1 mjerena 1 sat nakon doze u djece u dobi od 2 do <18 godina kretala se u rasponu od 20% do 88% u ispitivanju LEVP 2006-1 (liječenje) te od 22% do 46% u ispitivanju LEVP 2006-4 (prevencija) u usporedbi s 21% do 66% odnosno 25% do 32% u odraslih.