FrancophonIA/ELRC3.0 huggingface dataset:
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
Slovenian: O trombotičnih dogodkih so poročali pri novorojenčkih in dojenčkih, ki so za neodobrene indikacije prejemali velike odmerke kakega drugega zaviralca C1 (do 500 enot
English: The proportion of HAE attacks achieving unequivocal relief of the defining symptom within 4 hours after Cinryze treatment was comparable between the 22 children enrolled (age range: 2-17) and adults, with 89% and 86% of attacks achieving relief, respectively.
Slovenian: Delež napadov HAE, pri katerih je bilo doseženo nedvomno olajšanje opredeljujočega simptoma v največ 4 urah po zdravljenju z zdravilom Cimryze, je bil primerljiv pri 22 otrocih, vključenih v študijo (razpon starosti: 2-17), in odraslih.
English: Among these children, the only adverse reactions with Cinryze included headache, nausea, pyrexia, and infusion site erythema.
Slovenian: Pri teh otrocih so bili edini neželeni učinki zdravila Cinryze glavobol, navzea, zvišana telesna temperatura in eritem na mestu injiciranja.
English: Each powder vial contains 500 IU of C1 inhibitor.
Slovenian: Ena viala praška vsebuje 500 i.e. zaviralca C1.
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).
Slovenian: Študija je pokazala, da profilaksa z zdravilom Cinryze v primerjavi s placebom za več kot dvakrat zmanjša število napadov HAE (povprečje 6,3 napada za zdravilo Cinryze proti 12,8 napada za placebo, p<0,0001).
English: Two vials of reconstituted Cinryze correspond to a dose of 1000 IU.
Slovenian: Dve viali rekonstituiranega zdravila Cinryze ustrezata odmerku 1000 i.e.
English: Based upon the clinical data currently available, Cinryze has minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Na podlagi kliničnih podatkov, ki so trenutno na voljo, ima zdravilo Cinryze blag vpliv na sposobnost vožnje in upravljanja s stroji.
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.
Slovenian: Zdravnik, ki predpisuje zdravilo, se lahko odloči, da nekaterim bolnikom lahko daje zdravilo Cinryze doma oseba, ki ni zdravstveni delavec, na primer družinski član, ali da si zdravilo lahko dajejo zdravilo bolniki sami.
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
Slovenian: V študiji 0624-301 so pri 6 preiskovancih merili plazemske ravni antigena in funkcionalno aktivnost C1 INH pred odmerkom in 1 h po intravenski aplikaciji dveh različnih odmerkov zdravila Cinryze (500 enot in 1000 enot
English: Rash, erythema, pruritus Uncommon Contact dermatitis,
Slovenian: Bolezni kože in podkožja pogosti izpuščaj, eritem, pruritus občasni kontaktni dermatitis
English: For treatment, routine prevention and pre-procedure prevention in patients with renal or hepatic impairment, the dose is the same as for adults.
Slovenian: Odmerek za zdravljenje, preprečevanje in predoperativno preprečevanje pri bolnikih z okvarami ledvic ali jeter je enak kot pri odraslih.
English: Sodium citrate L-valine L-alanine L-threonine
Slovenian: Prašek: natrijev klorid saharoza natrijev citrat L-valin L-alanin L-treonin
English: Aseptic technique should be used during the administration procedure.
Slovenian: Med postopkom dajanja zdravila uporabljajte aseptično tehniko.
English: SOLVENT VIAL LABEL
Slovenian: NALEPKA NA VIALI VEHIKLA
English: Routine prevention of angioedema attacks
Slovenian: Rutinsko preprečevanje napadov angioedema
English: See section 2).
Slovenian: Glejte poglavje 2.
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
Slovenian: Študija 0624-203: Vključenih je bilo devet preiskovancev (starostna skupina 6-11 let), ki so prejeli enkraten odmerek zdravila Cinryze: 3 preiskovanci (10-25 kg) so prejeli 500 enot
English: A dose of 500 IU (one vial) of Cinryze should be injected at the first sign of a swelling attack.
Slovenian: Odmerek 500 i.e. (ena viala) zdravila Cinryze je treba injicirati ob prvem znaku napada otekanja.
English: Routine prevention of swelling attacks
Slovenian: Rutinsko preprečevanje napadov otekanja
English: One vial of reconstituted Cinryze corresponds to a dose of 500 IU.
Slovenian: Ena viala rekonstituiranega zdravila Cinryze ustreza odmerku 500 i.e.
English: Cinryze 500 IU powder and solvent for solution for injection C1 inhibitor (human)
Slovenian: Cinryze 500 i.e. prašek in vehikel za raztopino za injiciranje zaviralec C1 (humani)
English: Solvent for Cinryze Water for injections
Slovenian: vehikel za zdravilo Cinryze voda za injekcije
English: Summary of Product Characteristics and Patient Information Leaflet for Cinryze
Slovenian: Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila Cinryze; Izobraževalno gradivo za zdravstvene delavce;
English: Marketing Authorisation Holder Shire Services BVBA Rue Montoyer 47
Slovenian: Imetnik dovoljenja za promet z zdravilom Shire Services BVBA
English: The reconstituted product should be administered by intravenous injection at a rate of 1 ml per minute.
Slovenian: Rekonstituirano zdravilo injicirajte intravensko s hitrostjo 1 ml na minuto.
English: Children Treatment of angioedema attacks
Slovenian: Otroci Zdravljenje napadov angioedema
English: A dose of 1000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack.
Slovenian: Odmerek 1000 i.e. (dve viali) zdravila Cinryze je treba injicirati ob prvem znaku napada otekanja.
English: 9 subjects was 13.6 hours (range: 1.6-102.3 hours).
Slovenian: Mediani interval do popolnega izginotja napada HAE pri 9 preiskovancih je bil 13,6 ure (razpon: 1,6-102,3 ure).
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.
Slovenian: Zasukajte pripravo za prenos in vialo z vehiklom, ki vsebuje vodo za injekcije, na glavo in zapičite prozorni konec priprave za prenos v vialo s praškom.
English: After reconstitution, the product should be used immediately.
Slovenian: Zdravilo je treba uporabiti takoj po rekonstituciji.
English: What Cinryze contains
Slovenian: Kaj vsebuje zdravilo Cinryze
English: One IU is equivalent to the amount of C1 inhibitor present in 1 ml of normal human plasma.
Slovenian: Ena i.e. ustreza količini zaviralca C1 v 1 ml normalne humane plazme.
English: Cinryze 500 IU powder for solution for injection C1 inhibitor (human)
Slovenian: Cinryze 500 i.e. prašek za raztopino za injiciranje zaviralec C1 (humani) i.v.
English: Attach the syringe onto the top of the clear end of the transfer device by turning it clockwise.
Slovenian: Pritrdite brizgo na vrh prozornega konca priprave za prenos tako, da jo zasukate v smeri urnega kazalca.
English: Reconstitution and administration of Cinryze
Slovenian: Rekonstituiranje in dajanje zdravila Cinryze
English: One International Unit (IU) is equivalent to the amount of C1 inhibitor present in 1 ml of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) ustreza količini zaviralca C1 v 1 ml normalne humane plazme.
English: 500 IU of Cinryze at the first sign of the onset of an acute attack.
Slovenian: 500 i.e. zdravila Cinryze pri prvem znaku začetka akutnega napada.
English: Cinryze 500 IU powder and solvent for solution for injection
Slovenian: Cinryze 500 i.e. prašek in vehikel za raztopino za injiciranje
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.
Slovenian: Primarni substrat aktiviranega encima C1 je C4; nezavrt C1 povzroči zanižano raven C4. C1 je najpomembnejši zaviralec kontaktne aktivacije in uravnava kontaktni sistem in intrinzično koagulacijsko presnovno pot, tako da se veže na kalikrein in faktor XIIa in ju inaktivira.
English: Pre-procedure prevention of angioedema attacks
Slovenian: Predoperativno preprečevanje napadov angioedema
English: Treatment of angioedema attacks
Slovenian: Zdravljenje napadov angioedema
English: A doctor or nurse may prepare and inject Cinryze for you.
Slovenian: Zdravilo Cinryze bo za vas najbrž pripravil in vam ga injiciral zdravnik ali medicinska sestra.
English: Once the two vials are reconstituted proceed to administration process for a dose of 1000 IU
Slovenian: Ko sta viali rekonstituirani, nadaljujte s postopkom dajanja zdravila za odmerek 1000 i.e.
English: • 1000 IU of Cinryze at the first sign of the onset of an angioedema attack.
Slovenian: • 1000 i.e. zdravila Cinryze pri prvem znaku začetka napada angioedema.
English: Very common Nausea Common vomiting Uncommon Diarrhoea, abdominal pain
Slovenian: Bolezni prebavil zelo pogosti navzea pogosti bruhanje občasni driska, bolečine v trebuhu
English: Baseline-corrected AUC(0-t) (U*hr/ml)
Slovenian: na izhodišče popravljena AUC(0-t) (e*h/ml)
English: Date and time of treatment
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously (into the vein) into the patient.
Slovenian: Na brizgo, ki vsebuje raztopino zdravila Cinryze, pritrdite komplet za punkcijo vene in intravensko (v veno) injicirajte vsebino brizge bolniku.
English: The mean pharmacokinetic parameters for functional C1 inhibitor derived from baseline-corrected concentration data are presented in Table 2.
Slovenian: , ki mu je čez 60 minut sledil še en odmerek 1000 enot Povprečni farmakokinetični parametri za funkcionalni zaviralec C1, izračunani iz podatkov o koncentracijah, popravljenih na izhodišče, so navedeni v preglednici 2.
English: Cmax (U/ml)
Slovenian: Cmaks (e/ml)
English: Powder vial: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine, L-threonine Solvent vial: water for injections
Slovenian: Viala s praškom: natrijev klorid, saharoza, natrijev citrat, L-valin, L-alanin, L-treonin.
English: Cinryze contains sodium
Slovenian: Zdravilo Cinryze vsebuje natrij
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.
Slovenian: Če redno ali večkrat prejemate zdravila z zaviralcem C1, izdelana iz humane plazme, vam lahko zdravnik svetuje, da pretehtate možnost cepljenja proti hepatitisu A in B. Vsakokrat, ko prejmete odmerek zdravila Cinryze, mora vaša medicinska sestra ali zdravnik zabeležiti ime in številko serije zdravila, tako da se vodi dokumentacija o uporabljenih serijah.
English: Two vials of reconstituted Cinryze contain 1000 IU of C1 inhibitor (human) per 10 ml, corresponding to a concentration of 100 IU/ml.
Slovenian: Dve viali rekonstituiranega zdravila Cinryze vsebujeta 1000 i.e. zaviralca C1 (humanega) na 10 ml, kar ustreza koncentraciji 100 i.e./ml.
English: Venous thrombosis, phlebitis, venous burning, hot flush
Slovenian: Žilne bolezni občasni venska tromboza, flebitis, občutek pečenja v veni, vročinski oblivi
English: 2 filter transfer devices, 2 disposable 10 ml syringes, 2 venipuncture sets, and 2 protective mats.
Slovenian: 2 pripravi za prenos s filtrom, 2 10-mililitrski brizgi za enkratno uporabo, 2 kompleta za punkcijo vene, 2 zaščitni podlogi.
English: 1000 IU of Cinryze at the first sign of the onset of an acute attack.
Slovenian: 1000 i.e. zdravila Cinryze pri prvem znaku začetka akutnega napada.
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
Slovenian: Navodila za shranjevanje, odmerki in indikacije za zdravljenje, priprava enega odmerka zdravila Cinryze (500 i.e.) z rekonstitucijo ene viale, priprava enega odmerka zdravila Cinryze (1000 i.e.) z rekonstitucijo dveh vial, način rekonstitucije posamezne viale, tehnika intravenske injekcije, način in hitrost dajanja (injiciranja) enega odmerka zdravila Cinryze (500 i.e.), način in hitrost dajanja (injiciranja) enega odmerka zdravila Cinryze (1000 i.e.), navodilo, da je treba poiskati nujno medicinsko pomoč v primeru, ko ne uspe intravensko injiciranje, ali v primeru neučinkovitosti zdravila, navodila za ravnanje v primeru možnih neželenih učinkov, informacije, da je treba voditi dnevnik in v njem dokumentirati vsak doma prejeti odmerek zdravila, dnevnik pa prinesti na vsak zdravniški pregled.
English: Administration process for a dose of 500 IU
Slovenian: Postopek dajanja zdravila za odmerek 500 i.e.
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.
Slovenian: Bolniku dajte 500 i.e. (rekonstituiranih v 5 ml vode za injekcije) zdravila Cinryze intravensko s hitrostjo 1 ml na minuto v 5 minutah.
English: The information collected should include:
Slovenian: Zagotovljeno izobraževanje mora vsebovati naslednje elemente:
English: Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously into the patient.
Slovenian: Na brizgo, ki vsebuje raztopino zdravila Cinryze, pritrdite komplet za punkcijo vene in intravensko injicirajte vsebino brizge bolniku.
English: The existence of a post marketing registry in which health care professionals are encouraged to enter patients
Slovenian: Zdravstvene delavce naj se spodbudi k vpisu bolnikov v register.
English: Cinryze based on body weight (see section 5.1).
Slovenian: , 1000 enot ali 1500 enot zdravila Cinryze glede na telesno maso (glejte poglavje 5.1).
English: Detach the syringe from the vial by turning it anti-clockwise and releasing it from the clear end of the transfer device.
Slovenian: Ločite brizgo od viale tako, da jo zasukate v smeri urnega kazalca in jo snamete s prozornega konca priprave za prenos.
English: Treatment of swelling attacks
Slovenian: Zdravljenje napadov otekanja
English: Therefore two vials are combined for one dose of 1000 IU.
Slovenian: Zato za en odmerek 1000 i.e. združite dve viali.
English: Release the powder vial label by tearing down the perforated strip indicated by the inverted triangle.
Slovenian: Z viale s praškom strgajte perforirani trak, kot nakazuje obrnjen trikotnik, da postane vidna oznaka.
English: A dose of 500 IU (one vial) of Cinryze should be injected every 3 or 4 days for routine prevention of swelling attacks.
Slovenian: Za rutinsko preprečevanje napadov otekanja je treba injicirati odmerek 500 i.e. (eno vialo) zdravila Cinryze vsake 3 ali 4 dni.
English: A second dose of 500 IU may be administered if the patient has not responded adequately after 60 minutes.
Slovenian: Drugi odmerek 500 i.e. se sme aplicirati, če se bolnik v 60 minutah po prvem odmerku ne odzove primerno.
English: Two vials of reconstituted Cinryze are combined for a single dose.
Slovenian: Za enkraten odmerek morate združiti dve viali rekonstituiranega zdravila Cinryze.
English: Cinryze for the routine prevention of HAE attacks
Slovenian: Zdravilo Cinryze za preprečevanje napadov HAE
English: Age-group <6years: For the 3 subjects less than 6 years, administration of Cinryze (500 Units or 1000 Units
Slovenian: Starostna skupina <6 let: Pri 3 preiskovancih, mlajših od 6 let, je bila uporaba zdravila Cinryze (500 enot ali 1000 enot povezana s povišanjem ravni C1 INH in klinično učinkovitostjo pri akutnem zdravljenju in preprečevanju napadov.
English: A second dose of 1000 IU may be administered if the patient has not responded adequately after 60 minutes.
Slovenian: Drugi odmerek 1000 i.e. se sme aplicirati, če se bolnik v 60 minutah po prvem odmerku ne odzove primerno.
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.
Slovenian: Bolniku dajte 1000 i.e. (rekonstituiranih v 10 ml vode za injekcije) zdravila Cinryze intravensko (v veno) s hitrostjo 1 ml na minuto v 10 minutah.
English: Administer 1000 IU (reconstituted in 10 ml of water for injections) of Cinryze by intravenous injection at a rate of 1 ml per minute over 10 minutes.
Slovenian: Bolniku dajte 1000 i.e. (rekonstituiranih v 10 ml vode za injekcije) zdravila Cinryze intravensko s hitrostjo 1 ml na minuto v 10 minutah.
English: One vial of reconstituted Cinryze contains 500 IU of C1 inhibitor in 5 ml, resulting in a concentration of 100 IU/ml.
Slovenian: Ena viala rekonstituiranega zdravila Cinryze vsebuje 500 i.e. zaviralca C1 v 5 ml, koncentracija je 100 i.e. /ml.
English: • A second dose of 1000 IU may be administered if the patient has not responded adequately after 60 minutes.
Slovenian: • Drugi odmerek po 1000 i.e. smemo dati, če se bolnik 60 minut po prvem odmerku ne odzove primerno.
English: CARTON
Slovenian: Usin
English: Baseline-corrected Cmax (U/ml)
Slovenian: na izhodišče popravljena Cmaks (e/ml)
English: Very common headache Common
Slovenian: Bolezni živčevja zelo pogosti glavobol pogosti omotičnost
English: Two solvent vials.
Slovenian: 2 viali z vehiklom,
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.
Slovenian: Pritiskajte navzdol, dokler konica ne prodre skozi sredino zamaška viale z vehiklom in priprava ne zdrsne na svoje mesto.
English: For a dose of 1000 IU: Two powder vials, 2 solvent vials, 2 filter transfer devices, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat are needed.
Slovenian: Za odmerek 1000 i.e.: potrebujete 2 viali s praškom, 2 viali z vehiklom, 2 pripravi za prenos s filtrom, 1 10-mililitrsko brizgo za enkratno uporabo, 1 komplet za punkcijo vene in 1 zaščitno podlogo.
English: How to store Cinryze
Slovenian: Shranjevanje zdravila Cinryze
English: For a dose of 500 IU: One powder vial, 1 solvent vial, 1 filter transfer device, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat are needed.
Slovenian: Za odmerek 500 i.e.: potrebujete 1 vialo s praškom, 1 vialo z vehiklom, 1 pripravo za prenos s filtrom, 1 10-mililitrsko brizgo za enkratno uporabo, 1 komplet za punkcijo vene in 1 zaščitno podlogo.
English: Indication for treatment (acute attack or prophylaxis) Response to treatment
Slovenian: Zbrani podatki morajo obsegati: Datum in čas zdravljenja, številko serije in prejeti odmerek, indikacijo za zdravljenje (akuten napad ali profilaksa), odziv na zdravljenje, morebitne neželene učinke.
English: All 9 (100%) subjects achieved unequivocal beginning of relief of the defining symptom within 4 hours following initiation of treatment with Cinryze.
Slovenian: 4 urah po začetku zdravljenja z zdravilom Cinryze doseglo nedvoumen nastop olajšanja simptoma, ki opredeljuje napad HAE.
English: Uncommon Joint swelling, arthralgia, myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni otekanje sklepov, artralgija, mialgija
English: Remove the plastic package from the transfer device and discard it. Take care not to touch the exposed end of the transfer device.
Slovenian: Odstranite plastični omot s priprave za prenos in ga zavrzite.
English: After reconstitution, one vial contains 500 IU of C1 inhibitor (human) per 5 ml, corresponding to a concentration of 100 IU/ml.
Slovenian: Po rekonstituciji ena viala vsebuje 500 i.e. zaviralca C1 (humanega) na 5 ml, kar ustreza koncentraciji 100 i.e. /ml.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema pogosti preobčutljivost
English: A dose of 1000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical, dental, or surgical procedure.
Slovenian: Predoperativno preprečevanje napadov angioedema • 1000 i.e. zdravila Cinryze 24 ur pred internističnim, stomatološkim ali kirurškim posegom.
English: to prevent capillary leak syndrome.
Slovenian: /kg) za preprečevanje sindroma zvečane prepustnosti kapilar med posegi na srcu z zunajtelesnim krvnim obtokom.
English: The transfer device must be vertical prior to penetrating the stopper closure.
Slovenian: Preden priprava predre zamašek, mora biti v navpični legi.
English: Disconnect the solvent vial by turning it anti-clockwise.
Slovenian: Ločite vialo z vehiklom od priprave za prenos, tako da jo zasukate v nasprotni smeri urnega kazalca.
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje občasni hiperglikemija
English: /kg.
Slovenian: • spolovil.
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
Slovenian: Za en odmerek (1000 i.e. /10 ml) morate rekonstituirati dve viali praška Cinryze.
English: One powder vial, 1 solvent vial, 1 filter transfer device, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat is needed to prepare one dose of 500 IU.
Slovenian: Za pripravo enega odmerka 500 i.e. potrebujete 1 vialo s praškom, 1 vialo z vehiklom, 1 pripravo za prenos s filtrom, 1 10-mililitrsko brizgo za enkratno uporabo, 1 komplet za punkcijo vene in 1 zaščitno podlogo.
English: The instructions include the following main steps:
Slovenian: Navodila vključujejo naslednje glavne korake:
English: An attack usually lasts between 2 to 5 days.
Slovenian: Napad običajno traja 2 do 5 dni.
English: Important information for healthcare professionals and caregivers:
Slovenian: Pomembne informacije za zdravstvene delavce in negovalce:
English: ATC code: B06AC02.
Slovenian: oznaka ATC: B06AC02.
English: (Unknown)
Slovenian: (neznana)
English: The time to maximum concentration is approximately 30 minutes.
Slovenian: Čas do maksimalne koncentracije je približno 30 minut.
English: When and how often should you use Firazyr?
Slovenian: Kdaj in kako pogosto smete uporabljati zdravilo Firazyr?
English: No therapeutic intervention was necessary.
Slovenian: Terapevtski ukrepi niso bili potrebni.
English: All patients maintained efficacy.
Slovenian: Pri vseh bolnikih se je učinkovitost vzdrževala.
English: System Organ Class (incidence category)
Slovenian: Organski sistem (kategorija incidence)
English: D02 Y754, Ireland
Slovenian: D02 Y754, Irska
English: Statistic Firazyr
Slovenian: Statistika Firazyr
English: 1) General Information
Slovenian: 1) Splošne informacije
English: The terminal plasma half-life is about 1-2 hours.
Slovenian: Končna razpolovna doba v plazmi je približno 1-2 uri.
English: Date of first authorisation: 11 July 2008 Date of latest renewal: 13 March 2013
Slovenian: Datum zadnjega podaljšanja: 13. marec 2013
English: Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used.
Slovenian: Vaš zdravnik je določil natančen odmerek zdravila Firazyr in vam bo povedal, kako pogosto ga smete uporabljati.
English: 38 Number of subjects in ITT Population 27
Slovenian: 38 Število oseb v ITT
English: Each syringe should only be used once.
Slovenian: Vsaka brizga se lahko uporabi samo enkrat.
English: Information on individual race effect is limited.
Slovenian: Informacije o učinku pri posameznih rasah so omejene.
English: Efficacy data were obtained from an initial open-label Phase II study and from three controlled Phase III studies.
Slovenian: Podatki o učinkovitosti so bili pridobljeni iz začetne odprte študije faze II in iz treh kontroliranih študij faze III.