FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, fewer open-label Cinryze infusions were required for treatment of HAE attacks during therapy with Cinryze compared to placebo (mean 4.7 infusions vs. 15.4 infusions or 70% reduction, p<0.0001).
Slovenian: Poleg tega je bilo potrebnih manj odprtih infuzij zdravila Cinryze za zdravljenje napadov HAE med zdravljenjem z zdravilom Cinryze v primerjavi s placebom (povprečno 4,7 infuzije proti 15,4 infuzije ali 70-odstotno zmanjšanje, p<0,0001).
English: Inspect the reconstituted Cinryze solution for particulate matter prior to administration; do not use if particles are observed.
Slovenian: Pred dajanjem rekonstituirano raztopino zdravila Cinryze preglejte, ali vsebuje delce, in je ne uporabite, če opazite delce.
English: Among 84 separate laryngeal HAE attacks, none required intubation following treatment with Cinryze.
Slovenian: Od 84 posameznih laringealnih napadov HAE ni bila po zdravljenju z zdravilom Cinryze pri nobenem potrebna intubacija.
English: Cinryze is a white powder contained in a vial.
Slovenian: Zdravilo Cinryze je bel prašek v viali.
English: dental, or surgical procedure.
Slovenian: stomatološkim ali kirurškim posegom.
English: The educational pack should contain the following:
Slovenian: Izobraževalni paket mora vsebovati:
English: Do not take Cinryze
Slovenian: Ne jemljite zdravila Cinryze
English: For subjects receiving Cinryze prophylaxis for at least 1 year, the monthly attack rate per subject remained consistently low (0.34 attacks per month) relative to pre-study rates.
Slovenian: Pri preiskovancih, ki so prejemali profilakso z zdravilom najmanj eno leto, je bila pogostnost napadov na mesec na preiskovanca ves čas dosledno majhna (0,34 napada na mesec) v primerjavi s pogostnostjo pred študijo.
English: Do not shake the powder vial.
Slovenian: Viale s praškom ne stresajte.
English: Therefore, repeat instructions 1 to 12 above using an additional package containing a transfer device to reconstitute the second of two powder vials.
Slovenian: Zato ponovite zgornje korake 1 do 12 in uporabite dodatno pakiranje s pripravo za prenos, da boste rekonstituirali drugo vialo s praškom.
English: subjects (>25 kg) 1500 Units
Slovenian: (> 25 kg) 1000 enot in 3 preiskovanci (> 25 kg) 1500 enot
English: Adverse reactions to treatment with Cinryze are classified by MedDRA System Organ Class and absolute frequency in Table 1.
Slovenian: Neželeni učinki zdravljenja z zdravilom so v preglednici 1 razvrščeni po organskih sistemih po MedDRA in po absolutni pogostnosti.
English: [Historically assigned potency values were relative to an in-house reference standard whereby 1 Unit (U) is equal to the mean quantity of C1 inhibitor present in 1 ml of normal human plasma.]
Slovenian: [Zgodovinsko pripisane vrednosti aktivnosti so se nanašale na interni referenčni standard, kjer je 1 enota (e.) enaka povprečni količini zaviralca C1, prisotni v 1 ml normalne humane plazme.]
English: What Cinryze looks like and contents of the pack
Slovenian: Izgled zdravila Cinryze in vsebina pakiranja
English: It is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Cinryze
Slovenian: Zdravnik, ki predpisuje zdravilo, je odgovoren za to, da določi, kateri bolniki bi bili lahko primerni za uporabo zdravila doma oziroma za samozdravljenje z zdravilom Cinryze.
English: The vacuum in the powder vial will draw in the solvent.
Slovenian: Vakuum v viali s praškom bo vsrkal vehikel.
English: Remove plastic caps from the powder and solvent vials.
Slovenian: Odstranite plastična pokrovčka z vial s praškom in vehiklom.
English: Cinryze is intended for intravenous administration after reconstitution with water for injections.
Slovenian: Zdravilo Cinryze je namenjeno za intravensko uporabo po rekonstituciji z vodo za injekcije.
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).
Slovenian: V študiji LEVP 2005-1/B so uporabili randomiziran, dvojno slep, s placebom kontroliran navzkrižen načrt; 22 preiskovancev so ovrednotili glede učinkovitosti (randomizirane in zdravljene v obeh navzkrižnih obdobjih).
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Slovenian: Kljub tem ukrepom pri uporabi zdravil, pripravljenih iz humane krvi ali plazme, ni mogoče popolnoma izključiti možnosti prenašanja okužb.
English: Cinryze for the treatment of HAE attacks
Slovenian: Zdravilo Cinryze za zdravljenje napadov HAE
English: Prevention of swelling attacks prior to surgery
Slovenian: Preprečevanje napadov otekanja pred operacijo
English: 500 IU of Cinryze every 3 or 4 days is the recommended starting dose for routine prevention against angioedema attacks.
Slovenian: 500 i.e. zdravila Cinryze vsake 3 ali 4 dni je priporočeni začetni odmerek za rutinsko preprečevanje napadov angioedema.
English: Do not use the product if the solutions are turbid or discoloured.
Slovenian: Ne uporabite zdravila, če je katera od raztopin motna ali obarvana.
English: A leaflet providing detailed information on the key elements of the training that should be kept at home for further reference.
Slovenian: Bolnik naj doma hrani navodilo s podrobnostmi glede ključnih elementov izobraževanja zaradi nadaljnjih napotkov.
English: Cinryze is intended for intravenous administration (into the vein) after reconstitution with water for injections.
Slovenian: Zdravilo Cinryze je namenjeno za intravensko uporabo (v veno) po rekonstituciji z vodo za injekcije.
English: tmax (hr) [median (range)]
Slovenian: tmaks (h) [mediana (razpon)]
English: Non-clinical data reveal no special hazard for humans based on conventional studies of general toxicity and toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij splošne toksičnosti in toksičnosti za razmnoževanje ne kažejo posebnega tveganja za človeka.
English: There are limited data on the use of this medicinal product in home or self-administration.
Slovenian: Podatkov o uporabi tega zdravila na domu ali o samozdravljenju je malo.
English: The active substance is C1 inhibitor produced from the plasma of human donors.
Slovenian: Zdravilna učinkovina je zaviralec C1, izdelan iz plazme človeških dajalcev.
English: Cinryze therapy should be initiated under supervision of a physician experienced in the care of patients with hereditary angioedema (HAE).
Slovenian: Zdravljenje z zdravilom Cinryze se mora uvesti pod nadzorstvom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z dednim angioedemom (HAE).
English: Prior to enrollment, subjects reported a median monthly HAE attack rate of 3.0 (range: 0.08-28.0); during therapy with prophylactic Cinryze, this rate was 0.21 (range: 0-4.56), and 86% of subjects experienced an average of ≤1 attack per month.
Slovenian: Pred vključitvijo v študijo so preiskovanci poročali o mediani mesečni pogostnosti napadov HAE 3,0 (razpon: 0,08-28,0); med profilakso z zdravilom Cinryze je bila ta pogostnost 0,21 (razpon: 0-4,56), 86 % preiskovancev pa je imelo povprečno ≤1 napad na mesec.
English: Administration of C1 inhibitor increases serum levels of C1 inhibitor activity and temporarily restores the natural regulation of the contact, complement, and fibrinolytic systems thereby controlling the swelling or the propensity to swell.
Slovenian: Uporaba zaviralca C1 zviša serumsko raven aktivnosti zaviralca C1 in začasno obnovi naravno uravnavanje kontaktnega, komplementnega in fibrinolitičnega sistema, s čimer obvlada tudi otekanje oziroma nagnjenje k otekanju.
English: If these symptoms occur after administration, they should alert their physician.
Slovenian: Če se ti simptomi pojavijo po uporabi zdravila, mora bolnik to nemudoma povedati zdravniku.
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.
Slovenian: 5 ml vode za injekcije v viali iz neobarvanega stekla (tipa I), neprodušno zaprti z gumijastim zamaškom (tipa I) in aluminijasto zaporko s plastičnim pokrovčkom.
English: After reconstitution, the Cinryze solutions are colourless to slightly blue and clear.
Slovenian: Po rekonstituciji je raztopina zdravila Cinryze brezbarvna do rahlo modra in bistra.
English: Each kit contains material for either one 1000 IU dose or two 500 IU doses.
Slovenian: En komplet vsebuje material za en odmerek 1000 i.e. ali dva odmerka 500 i.e.
English: Cinryze is usually injected into a vein (intravenously) by your doctor or nurse.
Slovenian: Zdravilo Cinryze vam navadno injicira v veno (intravensko) vaš zdravnik ali medicinska sestra.
English: • The dosing interval may be adjusted by your doctor depending upon your response to Cinryze.
Slovenian: • Presledek med odmerki lahko vaš zdravnik prilagodi vašemu odzivu na zdravilo Cinryze.
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
Slovenian: 2 viali zdravila Cinryze 500 i.e. prašek za raztopino za injiciranje, 2 viali vode za injekcije (po 5 ml), 2 pripravi za prenos s filtrom,
English: Increases in C1 INH antigen levels and functional activity above the baseline values at 1 hour and 24 hours post-dose were demonstrated.
Slovenian: Ugotovili so zvišanje ravni antigena in funkcionalno aktivnost C1 INH nad izhodiščnimi vrednostmi 1 uro in 24 ur po odmerku.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
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).
Slovenian: V študiji LEVP 2005-1/A so uporabili randomiziran, dvojno slep, s placebom kontroliran načrt z vzporednimi skupinami; randomizirali so 71 preiskovancev z akutnimi napadi HAE (36 je prejemalo zdravilo Cinryze, 35 placebo).
English: Each single-use powder vial contains 500 International Units (IU) of C1 inhibitor (human) produced from the plasma of human donors.
Slovenian: Ena viala s praškom za enkratno uporabo vsebuje 500 mednarodnih enot (i.e.) zaviralca C1 (humanega), izdelanega iz plazme humanih dajalcev.
English: Do not remove the clear end of the transfer device from the powder vial.
Slovenian: Ne odstranite prozornega konca priprave za prenos z viale z vehiklom.
English: Study 0624-301: Six pediatric subjects (6 to 11 years of age ) were enrolled and randomized to twice weekly dosing for 12 weeks in 2 treatment sequences (500/1000 Units or 1000/500 Units
Slovenian: Študija 0624-301: sodelovalo je šest pediatričnih preiskovancev (starih od 6 do 11 let), ki so bili randomizirani za odmerjanje dvakrat tedensko v trajanju 12 tednov v 2 zaporedjih zdravljenja (500/1000 enot ali 1000/500 enot zdravila Cinryze).
English: The subjects received either a single intravenous dose of 1000 Units or a 1000 Units dose followed by a second dose of 1000 Units
Slovenian: Preiskovanci so prejeli bodisi enkraten intravenski odmerek 1000 enot bodisi odmerek 1000 enot
English: C1 inhibitor is a member of the serine protease inhibitor, or serpin, superfamily of proteins.
Slovenian: Zaviralec C1 spada v veliko skupino zaviralcev serinske proteaze ali serpinsko veliko skupino beljakovin.
English: The total number of days of swelling during prophylactic Cinryze therapy was reduced compared to placebo (mean 10.1 days vs. 29.6 days or a 66% reduction, p<0.0001).
Slovenian: Celotno število dni otekanja med profilaktičnim zdravljenjem z zdravilom Cinryze je bilo v primerjavi s placebom manjše (povprečje 10,1 dni proti 29,6 dni ali zmanjšanje za 66 %, p<0,0001).
English: Preparation and handling
Slovenian: Priprava in ravnanje z zdravilom
English: AUC(0-t) (U*hr/ml)
Slovenian: AUC(0-t) (e*h/ml)
English: CL (ml/min)
Slovenian: očistek (CL) (ml/min)
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).
Slovenian: Med profilaktičnim zdravljenjem z zdravilom Cinryze so bili napadi angioedema tudi manj hudi v primerjavi s placebom (povprečna ocena teže napada 1,3 proti 1,9 oziroma zmanjšanje za 32 %, p=0,0008) in so trajali krajši čas (povprečje 2,1 dni proti 3,4 dni oziroma skrajšanje za 38 %, p=0,0004).
English: • A dose of 1000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical,
Slovenian: • Odmerek 1000 i.e. (dve viali) zdravila Cinryze je treba injicirati do 24 ur pred internističnim,
English: It is the responsibility of the prescribing physician to provide appropriate training to the nonhealthcare professional who will administer the treatment at home, such as the patient for selfadministration or a family member.
Slovenian: Zdravnik, ki predpisuje zdravilo, je odgovoren za to, da poskrbi za ustrezno izobraževanje osebe, ki ni zdravstveni delavec in ki bo uporabljala zdravilo doma, na primer bolnik v primeru samozdravljenja ali družinski član.
English: • If you begin to suffer from rashes, tightness of the chest, wheezing, or a fast heart beat once you have taken Cinryze, you should tell your doctor immediately (see section 4).
Slovenian: • Če po tistem, ko ste prejeli zdravilo Cinryze, opazite nastanek izpuščaja, stiskanje v prsih, sopenje ali pospešen srčni utrip, morate to nemudoma povedati zdravniku.
English: Data on a limited number of exposed pregnancies indicate no adverse effects of C1 inhibitor on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available.
Slovenian: Podatki, pridobljeni na omejenem številu izpostavljenih nosečnosti, ne kažejo, da bi imel zaviralec C1 neželene učinke na nosečnost ali na zdravje ploda/novorojenčka.
English: The percentage of subjects with beginning of unequivocal relief of the defining symptom within 4 hours after dosing was 60% for Cinryze and 42% for placebo (p=0.062).
Slovenian: Odstotni delež preiskovancev, pri katerih se je začelo nedvomno olajšanje simptoma, ki opredeljuje napad HAE, v 4 urah po odmerku, je bil za zdravilo Cinryze 60 %, za placebo pa 42 % (p=0,062).
English: It is strongly recommended that every time Cinryze is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Slovenian: Vsakič, ko date bolniku zdravilo Cinryze, morate zapisati ime in številko serije zdravila, s čimer se vzpostavi povezava med bolnikom in serijo zdravila.
English: For treatment, routine prevention and pre-procedure prevention in adolescents 12 to 17 years old, the dose is the same as for adults.
Slovenian: Odmerek za zdravljenje, preprečevanje in predoperativno preprečevanje pri mladostnikih, starih 12 do 17 let, je enak kot pri odraslih.
English: Cinryze contains the human protein called “C1 inhibitor” as the active substance.
Slovenian: Zdravilo Cinryze vsebuje kot zdravilno učinkovino humano beljakovino, ki se imenuje “zaviralec C1”.
English: Elimination half-life (hr)
Slovenian: razpolovni čas odstranjevanja iz telesa (h)
English: Using a sterile, disposable 10 ml syringe, draw back the plunger to allow approximately 5 ml of air into the syringe.
Slovenian: Povlecite bat sterilne 10-militrske brizge za enkratno uporabo nazaj, da bo v brizgo vstopilo približno 5 ml zraka.
English: Both Cinryze doses resulted in relevant plasma levels of C1 INH antigen and functional activity.
Slovenian: Oba odmerka zdravila Cinryze sta povzročila pomembne plazemske koncentracije antigena in funkcionalno aktivnost C1 INH.
English: There was a statistically significant (p=0.0017) difference in the changes in mean values from baseline between treatment groups at 12 hours, demonstrating the association of Cinryze treatment with an increase in C4 activity (Cinryze + 2.9 mg/dl versus placebo + 0.1 mg/dl).
Slovenian: Zdravljenje z zdravilom Cinryze je po 12 urah povzročilo zvišanje ravni C4. Razlika med spremembami povprečnih vrednosti od izhodišča med zdravljenima skupinama po 12 urah je bila statistično značilna (p=0,0017), kar dokazuje povezavo med zdravljenjem z zdravilom Cinryze in zvišanjem aktivnosti C4 (Cinryze + 2,9 mg/dl proti placebu + 0,1 mg/dl).
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).
Slovenian: Študija je dokazala, da zdravljenje z zdravilom Cinryze v 4 urah po začetku napada HAE v primerjavi s placebom za več kot dvakrat skrajša čas do začetka nedvomnega olajšanja simptoma, ki opredeljuje napad HAE (mediana 2 uri za zdravilo Cinryze proti >4 uram za placebo, p=0,048).
English: It is the responsibility of the prescribing physician to verify that all the necessary skills have been acquired by the non-healthcare professional and that Cinryze may be safely and effectively administered at home.
Slovenian: Zdravnik, ki predpisuje zdravilo, se mora prepričati, da si je oseba, ki ni zdravstveni delavec, pridobila vse potrebno strokovno znanje in da se zdravilo Cinryze lahko varno in učinkovito uporablja doma.
English: Place the powder vial on a flat surface.
Slovenian: Položite vialo s praškom na ravno površino.
English: No maternal or embryofoetal effects of treatment were observed in reproductive studies in rats at dose levels up to 28-times the recommended human dose (1000 IU) based on an average adult body weight of 70 kg.
Slovenian: V retrospektivnih študijah na podganah pri odmerkih, ki so bili 28-krat večji od priporočenega odmerka za ljudi (1000 i.e.) na podlagi povprečne odrasle telesne mase 70 kg, niso opazili učinkov zdravljenja na mater, zarodek ali plod.
English: Therefore only reconstitute one vial of Cinryze for one dose of 500 IU.
Slovenian: Zato rekonstituirajte samo eno vialo zdravila Cinryze za en odmerek s 500 i.e.
English: The dosing interval may be adjusted by your doctor depending upon your response to Cinryze.
Slovenian: Zdravnik lahko prilagodi interval odmerjanja glede na vaš odziv na zdravilo Cinryze.
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.
Slovenian: do 7 dni, z izjemo 3-letnega otroka, ki je prejemal po 500 enot vsake 3 do 7 dni), imeli mediano mesečno pogostnost napadov HAE 0,4 (razpon: 0-3,4), 87 % otrok pa je poročalo o povprečno ≤1 napadu na mesec; ti rezultati so bili primerljivi s tistimi pri odraslih.
English: Powder vial: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine and L-threonine.
Slovenian: Viala s praškom: natrijev klorid, saharoza, natrijev citrat, L-valin, L-alanin in L-treonin.
English: Read all of this leaflet carefully before you start taking this medicine.
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo!
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
Slovenian: V študiji 0624-203 so preverili plazemske ravni antigena in funkcionalno aktivnost C1 INH pri 9 preiskovancih po enkratnem intravenskem odmerku 500 enot
English: Two powder vials.
Slovenian: 2 viali s praškom,
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.
Slovenian: Odmerek za zdravljenje, preprečevanje in predoperativno preprečevanje pri starejših bolnikih, starih 65 let in starejših, je enak kot pri odraslih.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Slovenian: Kljub temu pri uporabi zdravil, pripravljenih iz humane krvi in plazme, ni mogoče popolnoma izključiti možnosti prenosa povzročiteljev bolezni.
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.
Slovenian: 500 i.e. zaviralca C1 v viali iz neobarvanega stekla (tipa I), neprodušno zaprti z gumijastim zamaškom (tipa I) in aluminijasto zaporko s plastičnim pokrovčkom.
English: Overall administration of Cinryze was well tolerated.
Slovenian: Na splošno so preiskovanci dobro prenašali zdravilo Cinryze.
English: An international reference standard (IU) has now been implemented where IU is also defined as the amount of C1 inhibitor present in 1 ml of normal human plasma.
Slovenian: Zdaj je bil uveljavljen mednarodni referenčni standard (i.e.), kjer je i.e. opredeljena tudi kot količina zaviralca C1, prisotna v 1 ml normalne humane plazme.
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).
Slovenian: Zdravljenje z zdravilom Cinryze je tudi za več kot dvakrat skrajšalo čas do popolnega prenehanja in izginotja napada HAE v primerjavi s placebom (mediana 12,3 ure proti 31,6 ure, p=0,001).
English: Administration process for a dose of 1000 IU
Slovenian: Postopek dajanja zdravila za odmerek 1000 i.e.
English: Patients with renal or hepatic impairment
Slovenian: Bolniki z okvarami ledvic ali jeter
English: Your doctor will regularly review the preparation and administration process with you or a family member or carer.
Slovenian: Zdravnik bo redno ocenjeval, kako vi ali vaš družinski član/negovalec pripravljata in dajeta zdravilo.
English: Invert the vial gently and inject air into the solution and then slowly withdraw the reconstituted Cinryze solution into the syringe.
Slovenian: Nežno zasukajte vialo na glavo, vbrizgajte zrak v raztopino in nato počasi vsrkajte rekonstituirano raztopino zdravila Cinryze v brizgo.
English: Store below 25ºC.
Slovenian: Shranjujte pri temperaturi do 25 C.
English: Shire International Licensing B.V. Strawinskylaan 481
Slovenian: Strawinskylaan 481
English: A randomised, parallel group, open-label pharmacokinetic study of Cinryze was performed in subjects with non-symptomatic HAE.
Slovenian: Pri preiskovancih z asimptomatskim HAE so opravili randomizirano odprto farmakokinetično študijo zdravila Cinryze s paralelnimi skupinami.
English: In clinical studies, the intravenous administration of Cinryze resulted in a significant increase in systemic levels of antigenic and functional C1 inhibitor within 1 hour after administration.
Slovenian: V kliničnih študijah je intravenska uporaba zdravila Cinryze v eni uri po uporabi povzročila signifikantno zvišanje sistemskih ravni antigenskega in funkcionalnega zaviralca C1.
English: How to take Cinryze
Slovenian: Kako jemati zdravilo Cinryze
English: • A second injection of 1000 IU may be given if your symptoms do not improve after 60 minutes.
Slovenian: • Drugo injekcijo 1000 i.e. lahko prejmete, če se simptomi po 60 minutah ne izboljšajo.
English: 2 to 11 years, 10-25 kg: 500 IU of Cinryze within 24 hours before a medical, dental, or surgical procedure.
Slovenian: Od 2 do 11 let, 10-25 kg: 500 i.e. zdravila Cinryze 24 ur pred internističnim, stomatološkim ali kirurškim posegom.
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.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): preobčutljivost, omotičnost, bruhanje, izpuščaj, srbenje ali rdečica, izpuščaj ali bolečina na mestu injiciranja, zvišana telesna temperatura.