FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean pharmacokinetic parameters for functional C1 inhibitor derived from baseline-corrected concentration data are presented in Table 2.
Croatian: Srednje vrijednosti farmakokinetičkih parametara funkcionalnog inhibitora C1 dobivene iz podataka o koncentraciji korigiranih za početnu vrijednost prikazane su u tablici 2.
English: 5 ml of water for injections in a colourless glass vial (Type I), closed with a rubber stopper (Type I) and an aluminium seal with a plastic flip-off cap.
Croatian: 5 ml vode za injekcije u bočici od bezbojnog stakla (tip I), zatvorenoj gumenim čepom (tip I) i aluminijskim prstenom s plastičnim poklopcem.
English: Angioedema attacks were also less severe during prophylactic Cinryze therapy compared to placebo (mean severity score 1.3 vs. 1.9 or a 32% reduction, p=0.0008) and of shorter duration (mean 2.1 days vs. 3.4 days or a 38% reduction, p=0.0004).
Croatian: Napadaji angioedema bili su također manje teški tijekom profilaktičke terapije lijekom Cinryze u usporedbi s placebom (srednji broj bodova za težinu 1,3 naspram 1,9 ili smanjenje za 32%, p=0,0008) i kraće su trajali (srednje trajanje 2,1 dan naspram 3,4 dana ili smanjenje za 38%, p=0,0004).
English: • 1000 IU of Cinryze every 3 or 4 days is the recommended starting dose for routine prevention against angioedema attacks; the dosing interval may need to be adjusted according to individual response.
Croatian: • Preporučena početna doza za rutinsku prevenciju napadaja angioedema je 1000 IU lijeka Cinryze svaka 3 ili 4 dana; vremenski razmak između doza možda će trebati prilagoditi ovisno o odgovoru pojedinog bolesnika.
English: Two vials of reconstituted Cinryze are combined for a single dose.
Croatian: Dvije bočice rekonstituiranog lijeka Cinryze spajaju se za jednu dozu.
English: Aseptic technique should be used during the administration procedure.
Croatian: Tijekom postupka primjene potrebno je koristiti se aseptičkom tehnikom.
English: Routine prevention of angioedema attacks
Croatian: Rutinska prevencija napadaja angioedema
English: The reconstituted product should be administered by intravenous injection at a rate of 1 ml per minute.
Croatian: Rekonstituirani lijek treba primijeniti intravenskom injekcijom brzinom od 1 ml po minuti.
English: Mean Pharmacokinetic Parameters for Functional C1 Inhibitor Following Administration of Cinryze
Croatian: Tablica 2. Srednje vrijednosti farmakokinetičkih parametara za funkcionalni inhibitor C1 nakon primjene lijeka Cinryze
English: For treatment, routine prevention and pre-procedure prevention in elderly patients, 65 years of age or older, the dose is the same as for adults.
Croatian: Za liječenje, rutinsku prevenciju i prevenciju prije zahvata kod starijih bolesnika u dobi od 65 godina ili starijih doza je ista kao i kod odraslih.
English: Release the powder vial label by tearing down the perforated strip indicated by the inverted triangle.
Croatian: Uklonite naljepnicu na bočici s praškom tako što ćete otkinuti perforiranu traku na mjestu označenom obrnutim trokutom.
English: It is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Cinryze
Croatian: Odgovornost je liječnika koji propisuje lijek da odredi koji su bolesnici pogodni za primjenu kod kuće ili za samoprimjenu lijeka Cinryze.
English: Educational materials for non-healthcare professionals
Croatian: Edukacijski materijal za nezdravstvene radnike.
English: 500 IU of C1 inhibitor in a colourless glass vial (Type I), sealed with a rubber stopper (Type I) and an aluminium seal with a plastic flip-off cap.
Croatian: 500 IU inhibitora C1 u bočici od bezbojnog stakla (tip I), zatvorenoj gumenim čepom (tip I) i aluminijskim prstenom s plastičnim poklopcem.
English: Powder vial: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine, L-threonine Solvent vial: water for injections
Croatian: Bočica s praškom: natrijev klorid, saharoza, natrijev citrat, L-valin, L-alanin, L-treonin Bočica s otapalom: voda za injekcije
English: (), 1000 Units
Croatian: , 1000 jedinica
English: Each powder vial contains 500 IU of C1 inhibitor.
Croatian: Jedna bočica praška sadrži 500 IU inhibitora C1.
English: Powder vial: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine and L-threonine.
Croatian: Bočica praška: natrijev klorid, saharoza, natrijev citrat, L-valin, L-alanin i L-treonin.
English: In study 624-203, plasma C1 INH antigen and functional activity from 9 patients were obtained following a single IV dose of 500 Units
Croatian: U ispitivanju 0624-203 procijenjene su antigena i funkcionalna aktivnost C1 INH u plazmi u 9 bolesnika nakon jedne intravenske doze od 500 jedinica
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: Odluku da se pojedini bolesnik liječi kod kuće treba donijeti nadležni liječnik, koji treba osigurati odgovarajuću obuku bolesnika i povremeno provjeravati tehniku primjene.
English: Increases in C1 INH antigen levels and functional activity above the baseline values at 1 hour and 24 hours post-dose were demonstrated.
Croatian: Primijećena su povećanja razine antigene i funkcionalne aktivnosti C1 INH iznad početnih vrijednosti 1 sat i 24 sata nakon doze.
English: Only use a silicone-free syringe (provided in the pack) for administration of the product.
Croatian: Za primjenu lijeka smije se koristiti samo štrcaljka bez silikona (priložena u pakiranju).
English: 2 to 11 years, 10-25 kg: 500 IU of Cinryze within 24 hours before a medical, dental, or surgical procedure.
Croatian: 2 do 11 godina, 10-25 kg: 500 IU lijeka Cinryze unutar 24 sata prije medicinskog, zubarskog ili kirurškog zahvata.
English: The dosing interval may be adjusted by your doctor depending upon your response to Cinryze.
Croatian: Vaš liječnik će možda prilagoditi vremenski razmak između doza ovisno o Vašem odgovoru na Cinryze.
English: • A dose of 1000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical,
Croatian: • Dozu od 1000 IU (dvije bočice) lijeka Cinryze treba ubrizgati do 24 sata prije medicinskog,
English: Therefore only reconstitute one vial of Cinryze for one dose of 500 IU.
Croatian: Zato rekonstituirajte samo jednu bočicu lijeka Cinryze za jednu dozu od 500 IU.
English: Both Cinryze doses resulted in relevant plasma levels of C1 INH antigen and functional activity.
Croatian: Obje doze lijeka Cinryze rezultirale su značajnim razinama antigene i funkcionalne aktivnosti C1 INH u plazmi.
English: Common side effects (may affect up to 1 in 10 people): hypersensitivity, dizziness, vomiting, rash, itching or redness, injection site rash or pain, fever.
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): preosjetljivost, omaglica, povraćanje, osip, svrbež ili crvenilo kože, osip ili bol na mjestu injekcije, vrućica.
English: The study demonstrated that treatment with Cinryze within 4 hours after the onset of an HAE attack resulted in a greater than 2-fold decrease in the time to beginning of unequivocal relief of the defining symptom of the HAE attack compared to placebo (median 2 hours for Cinryze vs. >4 hours for placebo, p=0.048).
Croatian: Ispitivanje je pokazalo da je liječenje lijekom Cinryze unutar 4 sata od početka napadaja HAE više nego dvostruko skratilo vrijeme do početka vidljivog povlačenja glavnog simptoma napadaja HAE u usporedbi s placebom (medijan od 2 sata za Cinryze naspram >4 sata za placebo, p=0,048).
English: Thrombotic events have been reported in neonatal and infant subjects undergoing cardiac bypass procedures while receiving off-label high doses of another C1 inhibitor product (up to 500 Units
Croatian: Trombotički događaji zabilježeni su u novorođenčadi i dojenčadi podvrgnute postupcima ugradnje srčane premosnice dok su primala visoke doze drugog inhibitora C1 izvan odobrene indikacije (do 500 jedinica
English: Once reconstituted, Cinryze solution should be used immediately.
Croatian: Nakon rekonstitucije, otopinu lijeka Cinryze treba odmah primijeniti.
English: (), or 1500 Units
Croatian: (*), ili 1500 jedinica lijeka
English: Within 4 hours after Cinryze dosing, 87% of attacks achieved unequivocal relief of the defining symptom.
Croatian: Unutar 4 sata nakon primjene doze lijeka Cinryze vidljivo povlačenje glavnog simptoma postiglo se u 87% napadaja.
English: Treatment with Cinryze also resulted in a greater than 2-fold decrease in the time to complete resolution of the HAE attack compared to placebo (median 12.3 hours vs. 31.6 hours, p=0.001).
Croatian: Liječenje lijekom Cinryze također je više nego dvostruko skratilo vrijeme do potpunog nestanka napadaja HAE u usporedbi s placebom (medijan od 12,3 sata naspram 31,6 sati, p=0,001).
English: to prevent capillary leak syndrome.
Croatian: /kg) zbog sprječavanja sindroma povećane propusnosti kapilara.
English: After reconstitution, the Cinryze solutions are colourless to slightly blue and clear.
Croatian: Nakon rekonstitucije, otopine lijeka Cinryze bezbojne su do plavičaste i bistre.
English: Cinryze contains sodium
Croatian: Cinryze sadrži natrij
English: Shire International Licensing B.V. Strawinskylaan 481
Croatian: Strawinskylaan 481
English: The study demonstrated that prophylaxis with Cinryze resulted in a greater than 2-fold reduction in the number of HAE attacks compared to placebo (mean 6.3 attacks for Cinryze vs. 12.8 attacks for placebo, p<0.0001).
Croatian: Ispitivanje je pokazalo da je profilaksa lijekom Cinryze više nego dvostruko smanjila broj napadaja HAE u usporedbi s placebom (srednji broj napadaja 6,3 za Cinryze naspram 12,8 napadaja za placebo, p<0,0001).
English: Do not shake the powder vial.
Croatian: Nemojte tresti bočicu s praškom.
English: Injection site rash/erythema, infusion site pain, pyrexia
Croatian: Često osip/eritem na mjestu injekcije, bol na mjestu infuzije, pireksija
English: Two powder vials.
Croatian: Dvije bočice s praškom.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Cinryze 500 IU powder and solvent for solution for injection
Croatian: Cinryze 500 IU prašak i otapalo za otopinu za injekciju
English: Place the powder vial on a flat surface.
Croatian: Postavite bočicu s praškom na ravnu površinu.
English: The training to be provided should address the following elements Precaution for storage
Croatian: U obuci koja će se osigurati potrebno je osvrnuti se na sljedeće elemente Mjere opreza pri čuvanju lijeka
English: If your doctor decides you can selfadminister, your doctor or nurse will train you or a family member to prepare and inject Cinryze.
Croatian: Ako liječnik odluči da sami sebi možete davati lijek, liječnik ili medicinska sestra pokazat će Vama ili članu
English: Venous thrombosis, phlebitis, venous burning, hot flush
Croatian: Manje često venska tromboza, flebitis, žarenje vena, navale vrućine
English: During the study while receiving Cinryze prophylaxis (1000 Units every 3 to 7 days; with the exception of a 3 year old child, receiving 500 Units() every 3 to 7 days), children in the various age subgroups experienced median monthly HAE attack rates of 0.4 (range: 0-3.4), and 87% of children reported an average of ≤1 attack per month; these results were comparable to those observed in adults.
Croatian: koje je primalo 500 jedinica svakih 3 do 7 dana), djeca u raznim dobnim podskupinama imala su medijan učestalosti mjesečnih napadaja HAE od 0,4 (raspon: 0-3,4), a u 87% djece zabilježen je prosječno ≤1 napadaj mjesečno; ovi rezultati bili su usporedivi s onima opaženima u odraslih.
English: For some patients the prescribing physician may decide that Cinryze may be administered at home by a non-healthcare professional such as a family member or by self-administration.
Croatian: Liječnik koji propisuje lijek može odlučiti da nekim bolesnicima Cinryze može primjenjivati kod kuće nezdravstveni radnik, kao što je član obitelji, ili da ga mogu primjenjivati sami sebi.
English: Place the solvent vial on a flat surface and insert the blue end of the transfer device into the solvent vial, pushing down until the spike penetrates through the centre of the solvent vial stopper and the device snaps in place.
Croatian: Postavite bočicu s otapalom na ravnu površinu i uvedite plavi kraj naprave za prijenos u bočicu s otapalom tako što ćete ga utiskivati sve dok šiljak ne probije sredinu čepa na bočici s otapalom i naprava bude čvrsto spojena.
English: Remove protective covering from the top of the transfer device package.
Croatian: Uklonite zaštitnu foliju s pakiranja naprave za prijenos.
English: Invert the transfer device and the solvent vial containing water for injections and insert the clear end of the transfer device into the powder vial, pushing down until the spike penetrates the rubber stopper and the transfer device snaps into place.
Croatian: Okrenite napravu za prijenos i bočicu s otapalom koja sadrži vodu za injekcije i uvedite prozirni kraj naprave za prijenos u bočicu s praškom, tako što ćete ga utiskivati sve dok šiljak ne probije gumeni čep i naprava za prijenos bude čvrsto spojena.
English: Cinryze 500 IU powder and solvent for solution for injection C1 inhibitor (human)
Croatian: Cinryze 500 IU prašak i otapalo za otopinu za injekciju inhibitor C1 (ljudski)
English: Study LEVP 2005-1/A used a randomised, double-blind, placebo-controlled, parallel group design; 71 subjects with acute HAE attacks were randomised (36 Cinryze, 35 placebo).
Croatian: Cinryze u liječenju napadaja hereditarnog angioedema (HAE) Ispitivanje LEVP 2005-1/A bilo je ustrojeno kao randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje na usporednim skupinama; bio je randomiziran 71 ispitanik s akutnim napadajima HAE (36 Cinryze, 35 placebo).
English: Any adverse reactions
Croatian: Bilo koje nuspojave
English: One International Unit (IU) is equivalent to the amount of C1 inhibitor present in 1 ml of normal human plasma.
Croatian: Jedna međunarodna jedinica (IU) odgovara količini inhibitora C1 prisutnog u 1 ml normalne ljudske plazme.
English: Gently swirl the powder vial until all powder is dissolved.
Croatian: 11. Laganim kružnim pokretima okrećite bočicu sve dok se sav prašak ne otopi.
English: In Study 0624-301, plasma C1 INH antigen and functional activity were measured from 6 patients predose and 1h following IV administration of two dose levels of Cinryze (500 Units and 1000
Croatian: U ispitivanju 0624-301, antigena i funkcionalna aktivnost C1 INH u plazmi izmjereni su u 6 bolesnika prije primjene doze i 1 sat nakon intravenske primjene dvije razine doze lijeka Cinryze (500 jedinica i 1000 jedinica
English: Reconstitution and administration of Cinryze
Croatian: Rekonstitucija i primjena lijeka Cinryze
English: One vial of reconstituted Cinryze corresponds to a dose of 500 IU.
Croatian: Jedna bočica rekonstituiranog lijeka Cinryze odgovara dozi od 500 IU.
English: Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously (into the vein) into the patient.
Croatian: Spojite set za venepunkciju sa štrcaljkom koja sadrži otopinu lijeka Cinryze i ubrizgajte je intravenski (u venu) bolesniku.
English: 9 subjects was 13.6 hours (range: 1.6-102.3 hours).
Croatian: Medijan razdoblja do potpunog povlačenja napadaja HAE u navedenih 9 ispitanika bio je 13,6 sati (raspon: 1,6-102,3 sati).
English: Sodium citrate L-valine L-alanine L-threonine
Croatian: Prašak: natrijev klorid saharoza natrijev citrat L-valin L-alanin L-treonin
English: Do not use the product if the solutions are turbid or discoloured.
Croatian: Nemojte primijeniti lijek ako su otopine mutne ili su promijenile boju.
English: Study 0624-203: Nine subjects (age range: 6 - 11) were enrolled and received a single dose of Cinryze: 3 subjects (10 - 25 kg) received 500 Units(); 3 subjects (>25 kg) 1000 Units(), and 3
Croatian: Ispitivanje 0624-203: devet ispitanika (raspon dobi: 6 - 11) bilo je uključeno i primalo jednu dozu lijeka Cinryze: 3 ispitanika (10 - 25 kg) primilo je 500 jedinica
English: Once the two vials are reconstituted proceed to administration process for a dose of 1000 IU
Croatian: Kada su dvije bočice rekonstituirane prijeđite na postupak primjene za dozu od 1000 IU
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Cinryze vial is for single use only.
Croatian: Bočica lijeka Cinryze je samo za jednokratnu primjenu.
English: Study LEVP 2005-1/B used a randomised, double-blind, placebo-controlled, crossover design; 22 subjects were evaluable for efficacy (randomised and treated in both crossover periods).
Croatian: Cinryze za rutinsku prevenciju napadaja hereditarnog angioedema (HAE) Ispitivanje LEVP 2005-1/B bilo je ustrojeno kao randomizirano, dvostruko slijepo, placebom kontrolirano ukriženo ispitivanje; djelotvornost se mogla procijeniti u 22 ispitanika (randomizirani i liječeni u oba razdoblja ukriženog ispitivanja).
English: Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously into the patient.
Croatian: Spojite set za venepunkciju sa štrcaljkom koja sadrži otopinu lijeka Cinryze i ubrizgajte je intravenski bolesniku.
English: Two vials of reconstituted Cinryze correspond to a dose of 1000 IU.
Croatian: Dvije bočice rekonstituiranog lijeka Cinryze odgovaraju dozi od 1000 IU.
English: Administer 500 IU (reconstituted in 5 ml of water for injections) of Cinryze by intravenous injection at a rate of 1 ml per minute over 5 minutes.
Croatian: Primijenite 500 IU (rekonstituiranih u 5 ml vode za injekcije) lijeka Cinryze intravenskom injekcijom brzinom od 1 ml po minuti tijekom 5 minuta.
English: How to store Cinryze
Croatian: Kako čuvati Cinryze
English: Marketing Authorisation Holder Shire Services BVBA Rue Montoyer 47
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Shire Services BVBA
English: For treatment, routine prevention and pre-procedure prevention in patients with renal or hepatic impairment, the dose is the same as for adults.
Croatian: Za liječenje, rutinsku prevenciju i prevenciju prije zahvata kod bolesnika s oštećenjem funkcije bubrega ili jetre doza je ista kao i kod odraslih.
English: Preparation of one dose of Cinryze (500 IU) by reconstituting one vial Preparation of one dose of Cinryze (1000 IU) by reconstituting two vials Method of reconstitution of each vial
Croatian: Priprema jedne doze lijeka Cinryze (500 IU) rekonstitucijom jedne bočice Priprema jedne doze lijeka Cinryze (1000 IU) rekonstitucijom dviju bočica
English: Uncommon Joint swelling, arthralgia, myalgia
Croatian: Manje često oticanje zglobova, artralgija, mialgija
English: Very common Nausea Common vomiting Uncommon Diarrhoea, abdominal pain
Croatian: Manje često proljev, bol u abdomenu
English: Children Treatment of angioedema attacks
Croatian: Djeca Liječenje napadaja angioedema
English: The transfer device must be vertical prior to penetrating the stopper closure.
Croatian: Naprava za prijenos mora biti postavljena okomito prije probijanja čepa.
English: 2 vials of Cinryze 500 IU powder for solution for injection 2 vials of water for injections (5 ml each) 2 filter transfer devices
Croatian: 2 bočice lijeka Cinryze 500 IU prašak za otopinu za injekciju 2 bočice vode za injekciju (5 ml svaka) 2 naprave za prijenos s filtrom 2 štrcaljke od 10 ml za jednokratnu uporabu 2 seta za venepunkciju
English: • 1000 IU of Cinryze at the first sign of the onset of an angioedema attack.
Croatian: • 1000 IU lijeka Cinryze kod prvog znaka početka napadaja angioedema.
English: Cinryze 500 IU powder for solution for injection C1 inhibitor (human)
Croatian: Cinryze 500 IU prašak za otopinu za injekciju inhibitor C1 (ljudski) i.v. primjena
English: Treatment of angioedema attacks
Croatian: Liječenje napadaja angioedema
English: Date and time of treatment
Croatian: Te informacije trebaju uključiti: Datum i vrijeme liječenja
English: Instruction in handling possible adverse reactions Information on the need to keep a diary to document each treatment received at home and to bring it at each visit.
Croatian: Informacije o potrebi da se vodi dnevnik kako bi se zapisalo svako liječenje primljeno kod kuće i da se dnevnik donese prilikom svakog posjeta liječniku.
English: Among 84 separate laryngeal HAE attacks, none required intubation following treatment with Cinryze.
Croatian: Intubacija nije bila potrebna niti u jednom od 84 zasebna laringealna napadaja HAE nakon liječenja lijekom Cinryze.
English: Only frequencies based on reporting rates from clinical trials are used to assign frequency category.
Croatian: Za dodjelu kategorije učestalosti upotrebljavane su samo učestalosti koje se temelje na stopama prijava u kliničkim ispitivanjima.
English: Once the two vials are reconstituted proceed to administration process for a dose of 1000 IU.
Croatian: Kada su dvije bočice rekonstituirane prijeđite na postupak primjene za dozu od 1000 IU.
English: One IU is equivalent to the amount of C1 inhibitor present in 1 ml of normal human plasma.
Croatian: Jedna međunarodna jedinica odgovara količini inhibitora C1 prisutnoj u 1 ml normalne ljudske plazme.
English: • The dosing interval may be adjusted by your doctor depending upon your response to Cinryze.
Croatian: • Liječnik može prilagoditi vremenski razmak između doza ovisno o Vašem odgovoru na
English: 2 filter transfer devices, 2 disposable 10 ml syringes, 2 venipuncture sets, and 2 protective mats.
Croatian: 2 naprave s filtrom za prijenos, 2 štrcaljke od 10 ml za jednokratnu uporabu, 2 seta za venepunkciju i 2 zaštitne podloge.
English: Administer 1000 IU (reconstituted in 10 ml of water for injections) of Cinryze by intravenous injection (into the vein) at a rate of 1 ml per minute over 10 minutes.
Croatian: Primijenite 1000 IU (rekonstituiranih u 10 ml vode za injekcije) lijeka Cinryze intravenskom injekcijom (u venu) brzinom od 1 ml po minuti tijekom 10 minuta.
English: Detach the syringe from the vial by turning it anti-clockwise and releasing it from the clear end of the transfer device.
Croatian: Odvojite štrcaljku od bočice tako što ćete je zakrenuti u smjeru suprotnom od kazaljke na satu i odvojiti od prozirnog kraja naprave za prijenos.
English: Attach the syringe onto the top of the clear end of the transfer device by turning it clockwise.
Croatian: Spojite štrcaljku na vrh prozirnog kraja naprave za prijenos tako što ćete je zakrenuti u smjeru kazaljke na satu.
English: Two vials of reconstituted Cinryze contain 1000 IU of C1 inhibitor (human) per 10 ml, corresponding to a concentration of 100 IU/ml.
Croatian: Dvije bočice rekonstituiranog lijeka Cinryze sadrže 1000 IU inhibitora C1 (ljudskog) na 10 ml, što odgovara koncentraciji od 100 IU/ml.
English: • A second injection of 1000 IU may be given if your symptoms do not improve after 60 minutes.
Croatian: • Druga injekcija od 1000 IU može se dati ako Vam se simptomi ne poboljšaju nakon 60 minuta.
English: Summary of Product Characteristics and Patient Information Leaflet for Cinryze
Croatian: Sažetak opisa svojstava lijeka i Uputu o lijeku za Cinryze.
English: 2 powder vials, 2 solvent vials 2 filter transfer devices 2 disposable 10 ml syringes 2 venipuncture sets 2 protective mats
Croatian: 2 bočice s praškom2 bočice s otapalom2 naprave za prijenos s filtrom 2 štrcaljke od 10 ml za jednokratnu uporabu 2 seta za venepunkciju 2 zaštitne podloge
English: A second injection of 500 IU may be given if your symptoms do not improve after 60 minutes.
Croatian: Druga injekcija od 500 IU može se primijeniti ako se simptomi ne poboljšaju nakon 60 minuta.
English: One vial of reconstituted Cinryze contains 500 IU of C1 inhibitor in 5 ml, resulting in a concentration of 100 IU/ml.
Croatian: Jedna bočica rekonstituiranog lijeka Cinryze sadrži 500 IU inhibitora C1 u 5 ml, što daje koncentraciju od 100 IU/ml.