FrancophonIA/ELRC3.0 huggingface dataset:
English: No more than 2 doses, calculated according to step 7, should be given within 24 hours.
Croatian: Tijekom 24 sata ne smiju se dati više od dvije doze, koje se računaju prema uputama u 7. koraku.
English: Disinfect the injection site with an alcohol pad.
Croatian: Dezinficirajte mjesto davanja injekcije alkoholnim jastučićem.
English: • It is the responsibility of the physician to verify that all the necessary skills have been acquired by the non-Healthcare Professional and that Ruconest may be safely and effectively administered outside of a Healthcare Professional setting.
Croatian: • Odgovornost je liječnika utvrditi da je osoba koja nije zdravstveni radnik usvojila sve potrebne vještine i da se Ruconest može sigurno i učinkovito primijeniti bez prisutnosti zdravstvenog radnika.
English: Conestat alfa is the recombinant analogue of the human C1 esterase inhibitor (rhC1INH) produced by recombinant DNA technology in the milk of transgenic rabbits.
Croatian: Konestat alfa je rekombinantni analog ljudskog inhibitora C1 esteraze (rhC1INH) proizveden tehnologijom rekombinantne DNK iz mlijeka transgeničnih kunića.
English: No more than 2 doses should be given within 24 hours.
Croatian: Tijekom 24 sata ne smiju se primijeniti više od dvije doze.
English: Efficacy of Ruconest as a treatment for acute angioedema attacks was demonstrated by significantly shorter time to beginning of relief of symptoms and time to minimal symptoms and few therapeutic failures.
Croatian: Djelotvornost Ruconesta u liječenju akutnih napada angioedema pokazana je značajno kraćim vremenom do početka ublažavanja simptoma i vremenom do svođenja simptoma na minimalnu mjeru te malo terapijskih neuspjeha.
English: Saline n = 16
Croatian: fiziološka otopina n = 16
English: • Sensation of tingling, prickling or numbness in the skin or limb (paraesthesia)
Croatian: • Osjećaj trnaca, bockanja ili utrnulost kože ili udova (parestezija),
English: • The need to inform patients about the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, and that they should alert their physician if these symptoms occur.
Croatian: • Obvezu informiranja bolesnika o ranim znakovima reakcija preosjetljivosti, uključujući koprivnjaču i generaliziranu urtikariju, stezanje u prsištu, piskanje, hipotenziju i anafilaksiju, te potrebu da bolesnici obavijeste liječnika ako se ti simptomi pojave.
English: The patient card should contain the following key elements:
Croatian: Kartica za bolesnika mora sadržavati sljedeće ključne elemente:
English: Ruconest contains sodium (19.5 mg per vial)
Croatian: Ruconest sadrži natrij (19,5 mg po bočici)
English: Conestat alfa is a recombinant (not blood-derived) form of human C1 inhibitor (rhC1INH).
Croatian: Konestat alfa je rekombinantni (nije porijeklom iz krvi) oblik ljudskog inhibitora C1 esteraze (rhC1INH).
English: Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein.
Croatian: Konestat alfa dobiven je iz mlijeka transgeničnih kunića i sadrži tragove proteina kunića.
English: If two syringes were prepared: fold over the tubing to prevent backflow, unscrew the empty syringe from the infusion set (counter clockwise) and immediately replace it with the second syringe.
Croatian: Ako su pripremljene dvije štrcaljke: presavijte cijev kako biste spriječili povratni tok, odvrnite praznu štrcaljku sa seta za infuziju (u smjeru suprotnom od kazaljke na satu) i odmah je zamijenite drugom štrcaljkom.
English: - Body weight up to 84 kg One intravenous injection of 50 U/kg body weight.
Croatian: Jedna intravenska injekcija od 50 U/kg tjelesne težine.
English: The administration of Ruconest is to resolve the shortage of C1 inhibitor and will lead to reduction of symptoms of an acute attack of HAE.
Croatian: Ruconest se primjenjuje da bi se ispravio nedostatak inhibitora C1, što dovodi do smanjenja simptoma akutnog napada nasljednog angioedema.
English: • Use of Ruconest is only approved in acute attacks of hereditary angioedema.
Croatian: • Primjena Ruconesta odobrena je samo kod akutnih napada nasljednog angioedema.
English: • Turn the whole - solvent vial with adapter and syringe - upside down.
Croatian: • Okrenite cijeli spoj - bočicu s otapalom, nastavkom i štrcaljkom - naopačke.
English: However headache or vertigo have been reported following the use of Ruconest, but may also occur as a result of an attack of HAE.
Croatian: Međutim, nakon primjene Ruconesta prijavljene su glavobolja i vrtoglavica, iako one mogu biti i posljedica napada nasljednog angioedema.
English: The effect of conestat alfa on the following target proteases was assessed in vitro: activated C1s, kallikrein, factor XIIa and factor XIa.
Croatian: Učinak konestata alfa na sljedeće ciljne proteaze procijenjen je in vitro: aktivirani C1s,
English: • Place the syringe on the work surface, taking care not to touch the surface or any other object with the syringe tip.
Croatian: • Odložite štrcaljku na radnu površinu i pobrinite se da vrh štrcaljke ne dodiruje površinu niti bilo koji drugi predmet.
English: Patients must be closely monitored and carefully observed for any symptoms of hypersensitivity throughout the administration period.
Croatian: Tijekom razdoblja primjene bolesnike je potrebno pomno nadzirati i pratiti pojavu bilo kojeg simptoma preosjetljivosti.
English: What you need to know before you use Ruconest Do not use Ruconest:
Croatian: Što morate znati prije nego počnete primjenjivati Ruconest
English: The reconstituted solution in each vial should be visually inspected for particulate matter and discoloration.
Croatian: Rekonstituiranu otopinu u svakoj bočici mora se vizualno pregledati na prisutnost čestica i promjenu boje.
English: Step 6: Check prepared solutions
Croatian: 6. korak: Provjerite pripremljene otopine
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „Rok valjanosti“ ili kratice EXP.
English: Each vial of Ruconest is for single use only.
Croatian: Ruconesta je isključivo za jednokratnu uporabu.
English: In the majority of cases a single dose of Ruconest is sufficient to treat an acute angioedema attack.
Croatian: U većini slučajeva za liječenje akutnog napada angioedema dovoljna je jedna doza Ruconesta.
English: 5 minutes.
Croatian: 4 sata.
English: • The fact that Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins (Host Related Impurities, HRI).
Croatian: • Podatak da je Ruconest dobiven iz mlijeka transgeničnih kunića i da sadrži tragove proteina kunića (onečišćenja vezana uz domaćina).
English: • Push the solvent slowly, in a single motion, into the powder vial in order to minimise foaming.
Croatian: • Polako ubrizgavajte otapalo, u jednom pokretu, u bočicu s praškom kako biste pjenjenje sveli na najmanju moguću mjeru.
English: How to store Ruconest
Croatian: Kako čuvati Ruconest
English: Ruconest must be administered by a healthcare professional until you or your caregiver are properly trained and capable to administer Ruconest.
Croatian: Ruconest mora primjenjivati zdravstveni radnik dok Vi ili Vaš njegovatelj ne prođete odgovarajuću obuku i osposobite se za primjenu Ruconesta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: Do not remove the syringe packaging.
Croatian: Ne vadite štrcaljku iz pakiranja.
English: Patients should be advised not to drive and use machines if they experience headache or vertigo.
Croatian: Bolesnike je potrebno savjetovati da, ako osjete glavobolju ili vrtoglavicu, ne upravljaju vozilima i da ne rade sa strojevima.
English: The patient diary should contain the following key elements:
Croatian: Dnevnik za bolesnika treba sadržavati sljedeće ključne elemente:
English: • Carefully remove the plaster for securing the needle and withdraw the needle from the vein.
Croatian: • Pažljivo skinite flaster za učvršćivanje igle i izvucite iglu iz vene.
English: • Never exceed the volume of 14 ml per syringe.
Croatian: • Nikada nemojte prijeći volumen od 14 ml po štrcaljki.
English: Please safely dispose of the used infusion set with needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly.
Croatian: Na siguran način zbrinite iskorišteni set za infuziju s iglom, svu neiskorištenu otopinu, štrcaljku i praznu bočicu u prikladan spremnik za medicinski otpad, jer ti materijali mogu naškoditi drugima ako se pravilno ne zbrinu.
English: Abdominal discomfort Oral paraesthesia
Croatian: Nelagoda u trbuhu Oralna parestezija
English: Remove the needle cap from the needle of the infusion set and carefully insert the needle into the vein.
Croatian: Skinite poklopac s igle seta za infuziju i pažljivo ubodite iglu u venu.
English: Before Ruconest can be administered, it needs to be dissolved in water for injections, by a healthcare professional.
Croatian: Prije primjene Ruconesta, zdravstveni radnik mora ga otopiti u vodi za injekcije.
English: • Repeat the above steps for mounting an adapter on the solvent vial.
Croatian: • Ponovite gornje korake za namještanje nastavka na bočicu s otapalom.
English: • Remove the screw cap from the end of the infusion set.
Croatian: • Odvrnite čep s kraja seta za infuziju.
English: In case of an insufficient clinical response, an additional dose (50 U/kg body weight up to 4200 U) can be administered.
Croatian: U slučaju nedostatnog kliničkog odgovora moguće je primijeniti dodatnu dozu (50 U/kg tjelesne težine do najviše 4200 U).
English: • date and time of the administration
Croatian: • datum i vrijeme primjene
English: Throat irritation
Croatian: Iritacija grla
English: • Carefully insert the needle of the infusion set, at the flattest possible angle, into the vein.
Croatian: • Pažljivo uvedite iglu iz seta za infuziju, pod što manjim kutem, u venu.
English: In case of an insufficient clinical response, an additional dose (50 U/kg body weight up to 4200 U) can be administered (see section 5.1).
Croatian: U slučaju nedostatnog kliničkog odgovora moguće je primijeniti dodatnu dozu (50 U/kg tjelesne težine do najviše 4200 U) (vidjeti dio 5.1).
English: Never exceed 14 ml per syringe.
Croatian: Nikada nemojte premašiti količinu od 14 ml po štrcaljki.
English: 1 infusion set with needle 2 alcohol pads 1 sterile non-woven pad 1 adhesive plaster
Croatian: 1 set za infuziju s iglom2 alkoholna jastučića 1 sterilni netkani jastučić
English: • Abdominal pain, diarrhoea, nausea
Croatian: • Bol u trbuhu, proljev, mučnina,
English: Adverse reactions were usually mild to moderate in severity.
Croatian: U pogledu ozbiljnosti nuspojave su obično blage do umjerene.
English: • In addition to the kit, the following is required: - a tourniquet - plaster for securing the needle
Croatian: • Uz komplet, potrebni su: - podvez - flaster za učvršćivanje igle.
English: Preparation and handling
Croatian: Priprema i rukovanje
English: • Place the syringe(s) on the work surface, taking care not to touch the surface or any other object with the syringe tip.
Croatian: • Stavite štrcaljku/štrcaljke na radnu površinu i pobrinite se da vrh štrcaljke ne dodiruje površinu niti bilo koji drugi predmet.
English: Embryofetal studies in rat and rabbit; Daily single doses of vehicle or 625 U/kg/administration of rhC1INH were administered intravenously to mated rats and rabbits.
Croatian: Tijekom embriofetalnih ispitivanja na štakorima i kunićima koji su se parili, intravenski su primijenjene jednostruke dnevne doze pomoćne tvari ili 625 U/kg rhC1INH po primjeni.
English: • Remove the plastic flip-off cap from the powder and solvent vials.
Croatian: • Skinite plastični „flip-off” zaštitni poklopac s bočica s praškom i otapalom.
English: Disinfect the rubber stoppers of the powder and solvent vials and put a vial adapter onto each solvent and powder vial until it snaps onto the vial neck.
Croatian: Dezinficirajte gumene čepove bočica s praškom i otapalom i stavite nastavak na svaku bočicu s praškom i otapalom dok ne prione na vrat bočice.
English: The active substance is conestat alfa.
Croatian: Djelatna tvar je konestat alfa.
English: • Safely dispose of the used infusion set with needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly.
Croatian: • Na siguran način zbrinite iskorišteni set za infuziju s iglom, svu neiskorištenu otopinu, štrcaljku i praznu bočicu u prikladan spremnik za medicinski otpad, jer ti materijali mogu naštetiti drugima ako se pravilno ne zbrinu.
English: • Hold this end with one hand, attach the syringe tip end and secure by turning clockwise until it stops.
Croatian: • Držite taj kraj jednom rukom, spojite vrh štrcaljke i učvrstite je okretanjem u smjeru kazaljke na satu do kraja.
English: Step 8: Check prepared syringes • Recheck that the volume in the syringe(s) you prepared in step 7 is correct.
Croatian: • Ponovno provjerite da je volumen u štrcaljki/štrcaljkama koju/koje ste pripremili u 7. koraku ispravan.
English: Millilitres of prepared solution to be injected below 84 kg bodyweight in kg divided by three
Croatian: Ispod 84 kg tjelesna težina u kg podijeljena s tri
English: There is no clinical experience with Ruconest in patients with hepatic impairment.
Croatian: Nema kliničkih podataka o primjeni Ruconesta u bolesnika s oštećenjem jetrene funkcije.
English: Pack size of 1.
Croatian: Veličina pakiranja: 1 bočica.
English: • Necessary skills have to be acquired by non-Healthcare Professionals before Ruconest may be safely and effectively administered outside of a Healthcare Professional setting.
Croatian: • Osoba koja nije zdravstveni radnik najprije mora usvojiti potrebne vještine da bi se Ruconest mogao sigurno i učinkovito primijeniti bez prisutnosti zdravstvenoga radnika.
English: Solvent vial: Do no store above 25°C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C.
English: Do not use this medicine if you notice particles in the solution or if the solution is discolored.
Croatian: Nemojte primijeniti ovaj lijek ako primijetite čestice u otopini ili ako je otopina promijenila boju.
English: Sodium Citrate (E331), Citric Acid.
Croatian: Natrijev citrat (E331), Citratna kiselina.
English: Pharming Technologies B.V. Darwinweg 24
Croatian: Pharming Technologies B.V.
English: • 2 alcohol pads
Croatian: • 2 nastavka za bočice
English: • Leave the remainder of the solvent in the vial and discard the vial.
Croatian: • Ostatak otapala ostavite u bočici i bacite bočicu.
English: A solution exhibiting particulates or discoloration should not be used.
Croatian: Otopina u kojoj se vide čestice ili promjena boje ne smije se koristiti.
English: Solvent vial: 20 ml of water for injections in a vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Croatian: Bočica s otapalom: 20 ml vode za injekcije u bočici (staklo tipa 1) s čepom (silikonizirana klorobutilna guma) i „flip-off“ zaštitnim poklopcem (aluminij i obojena plastika).
English: Each vial of Ruconest (2100 U) should be reconstituted with 14 ml water for injections.
Croatian: Svaku bočicu Ruconesta (2100 U) potrebno je rekonstituirati s 14 ml vode za injekcije.
English: As for plasma-derived C1INH, the pharmacodynamic effects of conestat alfa on C4 show dose-dependent restoration of complement homeostasis in HAE patients at a plasma C1INH activity level greater than 0.7 U/ml, which is the lower limit of the normal range.
Croatian: farmakodinamički učinci konestata alfe na C4 u bolesnika s nasljednim angioedemom pokazuju obnovu homeostaze komplementa ovisnu o dozi pri razini djelovanja C1INH u plazmi većoj od
English: • The other ingredients of the powder are sucrose, sodium citrate (E331) and citric acid.
Croatian: • Drugi su sastojci praška saharoza, natrijev citrat (E331) i citratna kiselina.
English: 2100 U of conestat alfa powder in a 25 ml vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Croatian: 2100 U konestata alfa u prašku, u bočici od 25 ml (staklo tipa 1) s čepom (silikonizirana klorobutilna guma) i „flip-off“ zaštitnim poklopcem (aluminij i obojena plastika).
English: An aseptic technique should be used for reconstitution, combining and mixing the solutions.
Croatian: Za rekonstituciju, kombiniranje i miješanje otopina mora se primijeniti aseptična tehnika rada.
English: Ruconest will be given to you directly into a vein over a period of approximately 5 minutes by your doctor or by a nurse.
Croatian: Liječnik ili medicinska sestra davat će Vam Ruconest izravno u venu tijekom razdoblja od približno 5 minuta.
English: • Put the syringe(s) on the work surface.
Croatian: • Stavite štrcaljku/štrcaljke na radnu površinu.
English: If not used immediately in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: 24 sata na temperaturi od 2°C do 8°C, osim ako se postupak rekonstitucije lijeka za primjenu nije proveo u kontroliranim i validiranim aseptičkim uvjetima.
English: Gently press the syringe plunger to carefully fill the infusion set with the prepared solution.
Croatian: Lagano pritisnite klip štrcaljke da biste pažljivo napunili set za infuziju pripremljenom otopinom.
English: Water for injections should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution.
Croatian: Vodu za injekcije potrebno je dodavati polako kako bi se izbjegao silovit udar na prašak te lagano miješati da bi se pjenjenje otopine svelo na najmanju moguću mjeru.
English: • Summary of Product Characteristics and Patient Information Leaflet for Ruconest
Croatian: • sažetak opisa svojstava lijeka i uputu o lijeku za Ruconest
English: Each powder vial contains approximately 19.5 mg sodium.
Croatian: Svaka bočica s praškom sadrži približno 19,5 mg natrija.
English: • That Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins.
Croatian: • Podatak da je Ruconest dobiven iz mlijeka transgeničnih kunića i sadrži tragove proteina kunića.
English: For patients up to 84 kg calculate the volume required to be administered according to the formula below:
Croatian: U bolesnika tjelesne težine do 84 kg volumen potreban za primjenu izračunajte prema sljedećoj formuli:
English: 1 powder vial 1 solvent vial 2 vial adapters 1 syringe
Croatian: 1 bočicu s praškom 1 bočicu s otapalom2 nastavka za bočice 1 štrcaljku
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: Leave the syringe on the adapter.
Croatian: Ostavite štrcaljku na nastavku.
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Volumen za primjenu (ml)
English: - bodyweight 42 kg or less: 1 powder and 1 solvent vial - bodyweight over 42 kg: 2 powder and 2 solvent vials
Croatian: - tjelesna težina od 42 kg ili manje: 1 bočica s praškom i 1 bočica s otapalom
English: • If you have prepared two syringes: - fold over the tubing near the connector of the infusion set to prevent backflow - unscrew the empty syringe from the infusion set and immediately replace it with the second syringe
Croatian: Ako ste pripremili dvije štrcaljke: presavijte cjevčicu kako biste spriječili povratni tok, odvrnite praznu štrcaljku sa seta za infuziju (u smjeru suprotnom od kazaljke na satu) i odmah je zamijenite drugom štrcaljkom.
English: Step 12: Administration of the prepared solution
Croatian: 12. korak: Primjena pripremljene otopine
English: Ruconest 2100 U powder for solution for injection.
Croatian: Ruconest 2100 U prašak za otopinu za injekciju.
English: Do not use this medicine if, after dissolving, you notice particles in the solution or if the solution is discolored.
Croatian: Nemojte primijeniti ovaj lijek nakon otapanja ako primijetite čestice u otopini ili ako je otopina promijenila boju.
English: Ruconest will be initiated by a doctor who is specialised in the diagnosis and treatment of hereditary angioedema.
Croatian: Ruconest će Vam dati liječnik specijaliziran u dijagnosticiranju i liječenju nasljednog angioedema.
English: The other ingredients are sucrose, sodium citrate (E331) and citric acid.
Croatian: Drugi sastojci su saharoza, natrijev citrat (E331) i citratna kiselina.
English: Ensure that the tourniquet is released.
Croatian: Pobrinite se da se podvez otpusti.
English: • Put the vial adapters on the work surface.
Croatian: • Stavite nastavke za bočice na radnu površinu.
English: • That Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema.
Croatian: • Liječenje Ruconestom mora započeti pod vodstvom i nadzorom liječnika s iskustvom u dijagnostici i liječenju nasljednog angioedema.
English: Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema.
Croatian: Liječenje Ruconestom potrebno je započeti pod vodstvom i nadzorom liječnika s iskustvom u dijagnostici i liječenju nasljednog angioedema.
English: • Put the adapter onto a powder vial, piercing the stopper, until it snaps onto the vial neck.
Croatian: • Stavite nastavak na bočicu s praškom tako da probuši čep, dok ne prione na vrat bočice.
English: • The active substance is conestat alfa.
Croatian: • Djelatna tvar je konestat alfa.
English: Powder vial: 2100 U of conestat alfa powder in a vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Croatian: Bočica s praškom: 2100 U konestata alfa u prašku, u bočici (staklo tipa 1) s čepom (silikonizirana klorobutilna guma) i „flip-off“ zaštitnim poklopcem (aluminij i obojena plastika).
English: Hold the syringe with the tip pointing upwards and gently press the plunger to fill the infusion set with the solution.
Croatian: Držite štrcaljku tako da je vrh usmjeren prema gore i nježno gurajte klip kako biste otopinom napunili set za infuziju.
English: • Batch number and dose
Croatian: • Broj serije i dozu
English: Vertigo Paraesthesia
Croatian: Vrtoglavica Parestezija
English: The solvent should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution.
Croatian: Otapalo se treba dodavati polako da bi se izbjegao silovit udar na prašak te lagano miješati da bi se pjenjenje otopine svelo na najmanju moguću mjeru.
English: • 1 syringe
Croatian: • 1 štrcaljka
English: Check with your doctor or nurse if you are not sure.
Croatian: Ako niste sigurni, posavjetujte se sa svojim liječnikom ili medicinskom sestrom.
English: The reconstituted solution contains 150 U/ml conestat alfa and appears as a clear colourless solution.
Croatian: Rekonstituirana otopina sadrži 150 U/ml konestata alfa i izgleda kao bistra bezbojna otopina.
English: (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Sodium citrate (E331) Citric acid
Croatian: saharoza natrijev citrat (E331) citratna kiselina
English: The decision on the use of home-treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals.
Croatian: koji se treba pobrinuti za pružanje odgovarajuće obuke bolesnika i za povremenu provjeru primjene lijeka.
English: • That they are receiving Ruconest for treatment of acute attack of hereditary angioedema.
Croatian: • Podatak da bolesnik prima Ruconest radi liječenja akutnih napada nasljednog angioedema.