FrancophonIA/ELRC3.0 huggingface dataset:
English: • Known or suspected allergy to rabbits (see section 4.4) • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Croatian: • dokazana ili suspektna alergija na kuniće (vidjeti dio 4.4) • preosjetljivost na djelatnu ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: The information recorded should include: - Date and time of treatment - Batch number and dose - Response to treatment - Any adverse events
Croatian: Zabilježene informacije trebaju uključivati: - vrijeme i datum liječenja - broj serije i dozu - odgovor na liječenje - sve nuspojave
English: - check the expiry date.
Croatian: - provjerite rok valjanosti.
English: Inject the Ruconest solution immediately after preparation, preferably while seated.
Croatian: Ubrizgajte otopinu Ruconesta odmah nakon pripreme, po mogućnosti dok sjedite.
English: You or your caregiver may inject Ruconest only after receiving adequate instructions and training from your doctor or nurse.
Croatian: Vi ili Vaš njegovatelj smijete ubrizgati Ruconest tek nakon što Vam liječnik ili medicinska sestra pruže odgovarajuće upute i obuku.
English: • If you are or think you are allergic to rabbits • If you are allergic to conestat alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na konestat alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • Take a sterile syringe out of its packaging.
Croatian: • Izvadite sterilnu štrcaljku iz pakiranja.
English: Ruconest is supplied in a carton box containing one vial.
Croatian: Ruconest se isporučuje u kartonskoj kutiji koja sadrži jednu bočicu.
English: Broekman Institute B.V. Schoolstraat 21
Croatian: Broekman Institute B.V.
English: • Hold the adapter with one hand.
Croatian: • Držite nastavak jednom rukom.
English: • After the powder has dissolved, the solution should be clear and colourless.
Croatian: • Nakon što se prašak potpuno otopi, otopina treba biti prozirna i bezbojna.
English: - Body weight of 84 kg or greater
Croatian: - Tjelesna težina 84 kg ili veća
English: - unfold the tubing and gently inject this solution, similar to the first syringe
Croatian: - izravnajte cjevčicu i nježno ubrizgajte ovu otopinu, slično kao s prvom štrcaljkom
English: The medicinal product should be used immediately.
Croatian: Lijek je potrebno primijeniti odmah.
English: • Carefully pull back the syringe plunger slightly until you see blood being drawn into the tubing, to ensure that the needle is in the vein.
Croatian: • Pažljivo povucite klip štrcaljke malo unatrag dok ne ugledate kako se krv uvlači u cjevčicu kako biste bili sigurni da je igla u veni.
English: • Secure the needle by applying the plaster, around 7 cm long, over the wings of the needle.
Croatian: • Učvrstite iglu flasterom, dugim otprilike 7 cm, preko krilaca na igli.
English: For instructions on reconstitution of Ruconest before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji Ruconesta prije primijene vidjeti dio 6.6.
English: • Draw in the volume of prepared solution, while keeping the syringe in the vertical position.
Croatian: • Izvucite potrebni volumen pripremljene otopine dok držite štrcaljku u uspravnome položaju.
English: Ruconest should be administered by a healthcare professional.
Croatian: Ruconest mora primijeniti zdravstveni radnik.
English: • Use one alcohol pad to disinfect all vial stoppers and wait for at least 30 seconds until the stoppers have dried.
Croatian: • Alkoholnim jastučićem dezinficirajte sve čepove na bočicama i pričekajte barem 30 sekundi dok se čepovi ne osuše.
English: If you have prepared: - one vial with solution, draw up the volume as calculated - two vials and your bodyweight is below 84 kg, draw up in a similar way: a)14 ml from the first vial b) from the second vial, the difference between your calculated volume and the 14 ml from the first vial
Croatian: - jednu bočicu s otopinom, izvucite volumen koji ste izračunali - dvije bočice i Vaša je tjelesna težina ispod 84 kg, izvucite na sličan način: a)14 ml iz prve bočice b) iz druge bočice razliku između izračunatog volumena i 14 ml iz prve bočice
English: Ruconest is supplied with an administration kit in a carton box containing:
Croatian: Ruconest se isporučuje kao komplet za primjenu u kartonskoj kutiji koja sadrži:
English: • That they should be asked to carry the card and always show it to any Healthcare Professional treating them for acute attacks of hereditary angioedema.
Croatian: • Upozorenje da bolesnik mora nositi karticu i uvijek je pokazati svakom zdravstvenom radniku koji sudjeluje u liječenju akutnih napada nasljednog angioedema.
English: - Body weight up to 84 kg
Croatian: - Tjelesna težina do 84 kg
English: Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction.
Croatian: Prije početka liječenja Ruconestom bolesnike je potrebno pitati o prethodnoj izloženosti kunićima te o znakovima i simptomima koji upućuju na alergijsku reakciju.
English: The following describes how Ruconest solution must be prepared and administered.
Croatian: Sljedeće upute opisuju kako se otopina Ruconesta mora pripremiti i primijeniti.
English: • Diary to be given to patients before they receive Ruconest.
Croatian: • dnevnik koji treba uručiti bolesnicima prije nego prime Ruconest
English: Nine adolescent HAE patients (aged 13 to 17 years) were treated with 50 U/kg for 26 acute angioedema attacks, and 7 (aged 16 to 17 years) with 2100 U for 24 acute angioedema attacks.
Croatian: Devet adolescentnih bolesnika s nasljednim angioedemom (u dobi od 13 do 17 godina) liječeno je dozom od 50 U/kg u 26 akutnih napada angioedema, a njih 7 (u dobi od 16 do 17 godina) dozom od 2100 U u 24 slučaja akutnog napada angioedema.
English: Based on animal data, conestat alfa is cleared from the circulation by the liver via receptor-mediated endocytosis followed by complete hydrolysis/degradation.
Croatian: Na temelju podataka dobivenih na životinjama, konestat alfa iz cirkulacije uklanja jetra putem receptorski posredovane endocitoze praćene potpunom hidrolizom/degradacijom.
English: • The decision on the use of home treatment for an individual patient should be made by the treating physician.
Croatian: • Odluku o liječenju kod kuće za pojedinog bolesnika treba donijeti nadležni liječnik.
English: There is no excretion, as conestat alfa is cleared from the circulation via receptor-mediated endocytosis followed by complete hydrolysis/degradation in the liver.
Croatian: Izlučivanja nema, jer se konestat alfa iz cirkulacije uklanja putem receptorski posredovane endocitoze praćene potpunom hidrolizom/degradacijom u jetri.
English: • Check whether the powder in the vial(s) has dissolved completely and the plunger is completely pushed down in the syringe.
Croatian: • Provjerite je li se prašak u bočici/bočicama potpuno otopio i je li klip do kraja gurnut u štrcaljku.
English: administered (ml) = body weight (kg) times 50 (U/kg) 150 (U/ml)
Croatian: = tjelesna težina (kg) x 50 (U/kg) 150 (U/ml)
English: If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you should seek emergency medical assistance so that symptoms of your allergic reaction can be treated urgently.
Croatian: Ako nakon primjene Ruconesta osjetite alergijske reakcije, npr. koprivnjaču, osip, svrbež, omaglicu, piskanje, otežano disanje ili oticanje jezika, morate zatražiti hitnu medicinsku pomoć kako bi se simptomi alergijske reakcije mogli smjesta početi liječiti.
English: If your symptoms get worse and/or you develop a rash, tingling, difficulty breathing or your face or tongue swells up, get medical attention immediately.
Croatian: Ako Vam se simptomi pogoršaju i/ili primijetite osip, trnce, otežano disanje ili oticanje lica ili jezika,
English: Your dose, up to 2 vials, will be worked out based on your weight.
Croatian: Doza, najviše do 2 bočice, će se izračunati na temelju
English: • Date and time of treatment
Croatian: • Datum i vrijeme liječenja
English: Repeat this step if two powder vials need to be reconstituted.
Croatian: Ponovite ovaj korak ako trebate rekonstituirati dvije bočice s praškom.
English: • That Ruconest is contra indicated in all patients with known or suspected rabbit allergy.
Croatian: • Ruconest je kontraindiciran u svih bolesnika s dokazanom ili suspektnom alergijom na kuniće.
English: The instructions for use are clearly described in the doctor's information leaflet and are attached.
Croatian: Upute za primjenu jasno su objašnjene u informacijama namijenjenima zdravstvenim radnicima te su priložene.
English: It is not recommended to use Ruconest during pregnancy or breast-feeding.
Croatian: Ne preporučuje se primjena Ruconesta tijekom trudnoće i dojenja.
English: Continue to fill the syringe with the volume required.
Croatian: Nastavite puniti štrcaljku potrebnim volumenom otopine.
English: The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes.
Croatian: Potrebni volumen rekonstituirane otopine potrebno je primijeniti kao sporu intravensku injekciju tijekom približno 5 minuta.
English: In the randomized controlled trials 39/41 (95%) of patients treated with Ruconest reached time to beginning of relief within 4 hours.
Croatian: U randomiziranim kontroliranim ispitivanjima u 39/41 (95%) bolesnika liječenih Ruconestom, vrijeme do početka ublažavanja simptoma bilo je unutar 4 sata.
English: • Put the powder and solvent vials required on a flat and clean surface.
Croatian: • Stavite potrebne bočice s praškom i otapalom na ravnu i čistu površinu.
English: • Disinfect the injection site thoroughly with an alcohol pad and let the skin dry.
Croatian: • Temeljito dezinficirajte mjesto za davanje injekcije alkoholnim jastučićem i pričekajte da se koža osuši.
English: The plasma protein C1INH is the main regulator of activation of the contact and complement systems in vivo.
Croatian: Protein plazme C1INH glavni je regulator aktivacije sustava kontakta i komplemenata in vivo.
English: • 1 self-adhesive plaster
Croatian: • 1 samoljepljivi flaster
English: The MAH should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Ruconest are provided with an educational pack.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora se pobrinuti da, prilikom stavljanja lijeka na tržište, svi zdravstveni radnici od kojih se očekuje propisivanje Ruconesta dobiju edukacijske materijale.
English: Advice about the immunogenicity laboratory testing program for these antibodies provided by the company for following up suspected emergence of neutralising antibodies and information about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Croatian: Savjet o programu laboratorijskog testiranja imunogeničnosti radi otkrivanja tih antitijela koji osigurava tvrtka, radi praćenja suspektne pojave neutralizirajućih antitijela i informacije o postupku koji se primjenjuje pri prikupljanju i otpremi uzorka krvi u središnji laboratorij tvrtke.
English: Continue to fill the syringe with 14 ml solvent.
Croatian: Nastavite puniti štrcaljku sa 14 ml otapala.
English: Inhibition kinetics were found to be comparable with those observed for plasma-derived human C1INH.
Croatian: Kinetike inhibicije bile su usporedive s onima uočenim za humani C1INH dobiven iz plazme.
English: Home-treatment and self-administration
Croatian: Liječenje kod kuće i samoprimjena
English: The educational material for non-Healthcare Professionals should include information on the following key elements:
Croatian: Edukacijski materijali za osobe koje nisu zdravstveni radnici trebaju obuhvaćati informacije o sljedećim ključnim elementima:
English: Hepatic impairment may prolong the plasma half-life of conestat alfa, but this is not thought to be a clinical concern.
Croatian: Zbog oštećenja jetrene funkcije poluvijek konestata alfa u plazmi mogao bi se produljiti, ali se to ne smatra klinički značajnim.
English: Patients with HAE have low levels of C4 in the circulation.
Croatian: Bolesnici s nasljednim angioedemom imaju niske razine C4 u cirkulaciji.
English: Step 5: Adding solvent to powder and dissolving
Croatian: 5. korak: Dodavanje otapala prašku i otapanje
English: Time (minutes) to minimal symptoms median (95% CI)
Croatian: Vrijeme do svođenja simptoma na minimalnu mjeru (u minutama) - medijan (interval pouzdanosti 95%)
English: Gently inject the solution into the vein - inject over about 5 minutes.
Croatian: Nježno ubrizgajte otopinu u venu - ubrizgavajte u razdoblju od otprilike 5 minuta.
English: Fertility There are no data on the effects of Ruconest on male or female fertility.
Croatian: Nema podataka o učincima Ruconesta na plodnost muškaraca i žena.
English: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000),
Croatian: Učestalost nuspojava navedenih u nastavku definirana je prema sljedećim kategorijama: vrlo često (≥1/10) često (≥1/100 do <1/10) manje često (≥1/1000 do <1/100)
English: • The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
Croatian: • Potencijalni rizik od reakcije preosjetljivosti tipa III posredovane imunokompleksom zbog stvaranja antitijela na onečišćenja vezana uz domaćina (engl.
English: Contact your doctor or nearest hospital if this occurs.
Croatian: Ako se to dogodi, obratite se svojemu liječniku ili posjetite najbližu bolnicu.
English: Scientific literature indicates an interaction of tissue-type plasminogen activator (tPA) and C1INH containing medicinal products.
Croatian: Znanstvena literatura upućuje na interakcije s lijekovima koji sadrže tkivni aktivator plazminogena (tPA) i C1INH.
English: Tighten it to compress the vein.
Croatian: Zategnite ga kako biste stisnuli venu.
English: Ruconest must be administered by a healthcare professional until the patient (or caregiver) is competent to administer after having been properly trained and in agreement with the healthcare professional.
Croatian: Ruconest mora primijeniti zdravstveni radnik dok se bolesnik (ili njegovatelj) ne osposobi za primjenu tog lijeka nakon završetka odgovarajuće obuke i u dogovoru sa zdravstvenim radnikom.
English: • Take a packaged adapter in one hand and remove the lid.
Croatian: • Uzmite zapakirani nastavak u jednu ruku i skinite pokrov.
English: • 1 vial of 20 ml solvent
Croatian: • 1 bočicu s 20 ml otapala
English: - Information on the need to keep a diary to document each treatment administered at home and to bring it at each visit.
Croatian: - informacije o potrebi vođenja dnevnika kako bi se zabilježilo svako liječenje koje se primijenilo kod kuće i donošenja tog dnevnika prilikom svakog posjeta.
English: The clinical experience supporting safety of Ruconest consists of 300 administrations (83 administrations to healthy subjects or asymptomatic HAE patients and 217 administrations to 119 HAE patients).
Croatian: Tablični prikazi nuspojava Kliničko iskustvo koje potkrepljuje sigurnost Ruconesta temelji se na 300 primjena (83 primjene u zdravih ispitanika ili bolesnika s asimptomatskim nasljednim angioedemom i 217 primjena u 119 bolesnika s nasljednim angioedemom).
English: Ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
Croatian: Ruconest je indiciran za liječenje akutnih napada angioedema u odraslih i adolescenata s nasljednim angioedemom zbog nedostatka inhibitora C1 esteraze.
English: Ruconest is intended for intravenous administration after reconstitution with water for injections.
Croatian: Ruconest je namijenjen za intravensku primjenu nakon rekonstitucije s vodom za injekcije.
English: How to use Ruconest
Croatian: Kako primjenjivati Ruconest
English: • Leave the syringe on the adapter and gently swirl the vial for approximately half a minute.
Croatian: • Ostavite štrcaljku na nastavku i lagano vrtite bočicu otprilike pola minute.
English: Administration into a vein
Croatian: Primjena u venu
English: The amino acid sequence of conestat alfa is identical to that of endogenous C1INH.
Croatian: Slijed aminokiselina konestata alfa identičan je endogenom C1INH.
English: • It is the responsibility of the physician to provide the patient or a caregiver with instructions and training on administration outside of a clinic setting.
Croatian: • Obveza je liječnika pobrinuti se da bolesnik ili njegovatelj dobiju upute i obuku o primjeni lijeka izvan klinike.
English: For patients of 84 kg or above the volume required to be administered is 28 ml, corresponding to 4200 U (2 vials).
Croatian: U bolesnika težine 84 kg ili veće volumen koji je potrebno primijeniti iznosi 28 ml, što odgovara količini od 4200 U (2 bočice).
English: • Hives and swelling of the skin.
Croatian: • Koprivnjača i oticanje kože.
English: Solvent for Ruconest Water for injections
Croatian: Otapalo za Ruconest Voda za injekcije
English: • Check that no air is present in the syringe, infusion tube or the needle.
Croatian: • Provjerite da u štrcaljki, cjevčici za infuziju ili igli nema zraka.
English: Ruconest is presented as a single glass vial containing a white to off-white powder for solution for injection.
Croatian: Ruconest je dostupan kao jedna staklena bočica koja sadrži bijeli do gotovo bijeli prašak za otopinu za injekciju.
English: • Copies of the patient card to be given to patients before they receive Ruconest.
Croatian: • primjerke kartice za bolesnika koji će se bolesnicima dati prije nego što prime Ruconest.
English: Inform your healthcare professional if this occurs.
Croatian: Ako se to dogodi, obavijestite svojega zdravstvenoga radnika.
English: • Position the tourniquet above the injection site - preferably the middle part of the upper arm.
Croatian: • Namjestite podvez iznad mjesta za davanje injekcije - po mogućnosti na srednji dio nadlaktice.
English: Advice about the immunogenicity laboratory testing program for detecting these antibodies for following up suspected immune complex-mediated disease, and about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Croatian: Savjet o programu laboratorijskog testiranja imunogeničnosti radi otkrivanja tih antitijela i praćenja suspektne bolesti posredovane imunokompleksom te o postupku koji se primjenjuje pri prikupljanju i otpremi uzorka krvi u središnji laboratorij tvrtke.
English: • Hold the syringe with the tip pointing upwards.
Croatian: • Držite štrcaljku tako da je vrh usmjeren prema gore.
English: After administration of Ruconest (50 U/kg) to asymptomatic HAE patients, a Cmax of 1.36 U/ml was observed.
Croatian: Nakon primjene Ruconesta (u dozi od 50 U/kg) asimptomatskim bolesnicima s nasljednim angioedemom, uočen je Cmax od 1,36 U/ml.
English: • Hold the adapter with the other hand and attach the syringe.
Croatian: • Držite nastavak drugom rukom i spojite štrcaljku.
English: 1 Unit of conestat alfa activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 ml of pooled normal plasma.
Croatian: Aktivnost 1 jedinice konestata alfa odgovara inihibirajućoj aktivnosti C1 esteraze u 1 ml prikupljene normalne plazme.
English: The solvent is a clear, colourless liquid.
Croatian: Otapalo je prozirna, bezbojna tekućina.
English: Time (minutes) to beginning of relief median (95% CI)
Croatian: Vrijeme do početka ublažavanja (u minutama) - medijan (interval pouzdanosti 95%)
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 je potrebno obavijestiti o ranim znacima reakcija preosjetljivosti, uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje, hipotenziju i anafilaksiju.
English: Sucrose,
Croatian: Saharoza,
English: Step 10: Preparation of the infusion set
Croatian: 10. korak: Priprema seta za infuziju
English: • Check that all required components are on the work surface: - 1 or 2 syringes with prepared solution - 1 infusion set with 25G needle - 1 alcohol pad - 1 sterile non-woven pad - 1 self-adhesive plaster - 1 tourniquet - 1 plaster for securing the needle
Croatian: • Provjerite nalaze li se na radnoj površini sve potrebne komponente: - 1 ili 2 štrcaljke s pripremljenom otopinom - 1 set za infuziju s iglom od 25G
English: • There are limited data on the use of this medicinal product in home or self-administration.
Croatian: • Podaci o primjeni ovoga lijeka kod kuće ili o njegovoj samoprimjeni su ograničeni.
English: HAE patients have a heterozygous deficiency of the plasma protein C1INH.
Croatian: Bolesnici s nasljednim angioedemom imaju heterozigotni nedostatak plazmatskog proteina C1INH.
English: If air bubbles appear, minimise as far as possible by gently tapping the syringe and applying gentle pressure by pushing the plunger into the syringe.
Croatian: Ako se pojave mjehurići zraka, rasplinite ih koliko je moguće nježnim tapkanjem štrcaljke i laganim pritiskom guranjem klipa u štrcaljku.
English: Reconstitute each vial with 14 ml water for injections (see section on Reconstitution below).
Croatian: Svaku bočicu rekonstituirajte s 14 ml vode za injekcije (vidjeti dio o Rekonstitucija u nastavku).
English: The educational pack should contain the following:
Croatian: Edukacijski materijali moraju sadržavati sljedeće:
English: Ruconest is presented as a single glass vial containing a white to off-white powder for solution for injection together with one glass vial containg a clear, colourless solvent to dissolve the powder.
Croatian: Ruconest je dostupan kao jedna staklena bočica koja sadrži bijeli do gotovo bijeli prašak za otopinu za injekciju s jednom staklenom bočicom koja sadrži prozirno, bezbojno otapalo za otapanje praška.
English: Repeat this step if a second powder vial needs to be reconstituted.
Croatian: Ponovite ovaj korak ako trebate rekonstituirati drugu bočicu s praškom.
English: Draw in the required volume of prepared solution.
Croatian: Izvucite potreban volumen pripremljene otopine.
English: The doses evaluated in the clinical studies ranged from a single vial of 2100 U (corresponding to 18-40 U/kg), to 50 and 100 U/kg.
Croatian: Doze procijenjene u kliničkim ispitivanjima kretale su se u rasponu od jedne bočice od 2100 U (što odgovara 18 - 40 U/kg) do 50 i 100 U/kg.
English: In an open label study 114/119 (95%) attacks treated with a single dose of 50 U/kg reached time to beginning of relief within 4 hours.
Croatian: U otvorenim ispitivanjima u 114/119 (95%) napada liječenih jednom dozom od 50 U/kg, vrijeme do početka ublažavanja simptoma bilo je unutar 4 sata.
English: There is no experience with the use of Ruconest in pregnant and breast-feeding women.
Croatian: Nema iskustava s primjenom Ruconesta u trudnica i dojilja.
English: The educational material for the Healthcare Professional should include information on the following key elements:
Croatian: Edukacijski materijali za zdravstvenoga radnika moraju sadržavati informacije o sljedećim ključnim elementima:
English: Gently inject the solution of the second syringe.
Croatian: Nježno ubrizgajte otopinu iz druge štrcaljke.
English: • the batch number written on the label of the powder vial
Croatian: • broj serije naveden na naljepnici bočice s praškom
English: In HAE patients, Ruconest at a dose of 50 U/kg increases plasma C1INH activity level to greater than 0.7 U/ml for approximately 2 hours (see section 5.2).
Croatian: U bolesnika s nasljednim angioedemom, doza Ruconesta od 50 U/kg povisuje razinu djelovanja C1INH u plazmi na više od 0,7 U/ml za približno 2 sata (vidjeti dio 5.2).
English: Ruconest is to be used by adults and adolescents with a rare inherited blood disorder, called Hereditary Angioedema (HAE).
Croatian: Ruconest je namijenjen za primjenu u odraslih i adolescenata s rijetkim nasljednim poremećajem krvi zvanim nasljedni angioedem.