natgillin/translations-raw huggingface dataset:
Store the remaining vial and administration equipments for the next dose.
Preostalo vialo in pripomočke za dajanje zdravila shranite za naslednji odmerek.
Adverse reaction frequencies were estimated from 2 pivotal placebo-controlled and 2 open-label studies in 251 unique subjects.
Pogostnosti neželenih učinkov so ocenili na podlagi 2 osrednjih, s placebom nadzorovanih, in 2 odprtih študijah pri 251 edinstvenih osebah.
Very common side effects (may affect more than 1 in 10 people): headache, nausea.
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): glavobol, navzea.
Using the same syringe, repeat steps 3 to 6 with a second vial of reconstituted Cinryze to make one complete 10 ml dose.
Z isto brizgo ponovite korake 3 do 6 z drugo vialo rekonstituiranega zdravila Cinryze, da boste dobili kompleten 10-mililitrski odmerek.
• Additional risk minimisation measures Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Pred uvedbo zdravila na trg v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom uskladiti vsebino in obliko izobraževalnega gradiva z nacionalnim pristojnim organom.
Each pack of Cinryze contains:
Eno pakiranje zdravila Cinryze vsebuje:
Note: the transfer device must be attached to the solvent vial before being attached to the powder vial, so that the vacuum in the powder vial is not lost.
Opozorilo: pripravo za prenos morate pritrditi na vialo z vehiklom, preden jo pritrdite na vialo s praškom, da se ne izgubi vakuum v viali s praškom.
Within 4 hours after Cinryze dosing, 87% of attacks achieved unequivocal relief of the defining symptom.
V štirih urah po odmerku zdravila Cinryze je pri 87 % napadov nastopilo nedvomno olajšanje opredeljujočega simptoma.
As such, the pharmacokinetics and excretion of Cinryze are not expected to be altered by renal or hepatic impairment.
Zato ne pričakujemo, da bi se farmakokinetika in izločanje zdravila Cinryze spremenila zaradi okvare ledvic ali jeter.
2 protective mats
2 zaščitni podlogi.
Median interval was 0.5 hours (range: 0.25-2.5 hours): 1.25, 0.25, and 0.5 hours in the 500 Units(), 1000 Units(), and 1500 Units() Cinryze groups, respectively.
Mediani interval je bil 0,5 ure (razpon: 0,25-2,5 ure): 1,25, 0,25 in 0,5 ure pri 500 enotah
C1 inhibitor is a single chain glycoprotein found in plasma which, in its mature state, consists of 478 amino acids with an apparent molecular weight of 105 kD.
Zaviralec C1 je glikoprotein iz ene same verige, najdemo ga v plazmi, v svojem zrelem stanju pa je sestavljen iz 478 aminokislin z navidezno molekulsko maso 105 kD.
Cleanse stoppers with a disinfection swab and allow them to dry prior to use.
Obrišite zamaška z zložencem za dezinfekcijo in ju pustite, da se pred uporabo posušita.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Izvedeni ukrepi veljajo za učinkovite za viruse z ovojnico, na primer HIV, HBV in HCV, in za gola virusa HAV in parvovirus B19.
Necessary skills have to be acquired by non-healthcare professionals before Cinryze may be safely and effectively administered at home.
Osebe, ki niso zdravstveni delavci, si morajo pridobiti potrebno znanje, preden se lahko zdravilo Cinryze varno in učinkovito uporabljajo doma.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Med temi ukrepi sta skrbna izbira dajalcev krvi in plazme, ki zagotavlja, da sta izključeni kri in plazma tveganih dajalcev, s katerima bi se lahko prenašale okužbe, in testiranje vsake enote darovane krvi posameznih dajalcev in zalog plazme na znake virusov/okužb.
Because C1 inhibitor is an endogenous human plasma protein, it is not subject to metabolism by Cytochrome P450 iso-enzymes, excretion, or pharmacokinetic drug-drug interactions exhibited by many low molecular weight compounds.
Ker je zaviralec C1 endogena humana plazemska beljakovina, ni izpostavljen presnavljanju z izoencimi citokroma P450, izločanju ali farmakokinetičnim interakcijam med zdravili, kot so številne spojine z majhno molekulsko maso.
Do not reuse the transfer device.
Ne uporabite še enkrat že uporabljene priprave za prenos.
In all studies, administration of Cinryze resulted in increases in antigenic and functional C1 inhibitor levels post-infusion compared to pre-infusion values in both children and adults.
V vseh študijah je uporaba zdravila Cinryze zvečala ravni antigenskega in funkcionalnega inhibitorja C1 po infuzijah v primerjavi z vrednostmi pred infuzijami pri otrocih in odraslih.
Mean increases from baseline in functional C1 inhibitor activity measured 1 hour post-dose in children 2 to <18 years of age ranged from 20% to 88% in Study LEVP 2006-1 (treatment) and from 22% to 46% in Study LEVP 2006-4 (prevention) compared with 21% to 66% and 25% to 32% in adults, respectively.
Povprečno zvečanje aktivnosti funkcionalnega zaviralca C1 od izhodišča, izmerjeno 1 uro po odmerku pri otrocih, starih 2 do <18 let, je bilo med 20 % in 88 % v študiji LEVP 2006-1 (zdravljenje) in med 22 % in 46 % v študiji LEVP 2006-4 (preprečevanje) v primerjavi z 21 % do 66 % in 25 % do 32% pri odraslih.
Home-treatment and self-administration
Zdravljenje na domu in samozdravljenje
The mean elimination half-life of functional C1 inhibitor after administration of Cinryze was 56 hours for a single dose and 62 hours for the double dose.
Povprečni razpolovni čas odstranjevanja funkcionalnega zaviralca C1 iz telesa po aplikaciji zdravila Cinryze je bil 56 ur pri enkratnem odmerku in 62 ur pri dvojnem odmerku.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Bolnike moramo poučiti o začetnih znakih preobčutljivostnih reakcij, vključno s koprivnico, generalizirano urtikarijo, stiskanjem v prsih, sopenjem, hipotenzijo in anafilaksijo.
Cinryze vial is for single use only.
Viala zdravila Cinryze je samo za enkratno uporabo.
The educational material for healthcare professionals should include information on the following key elements:
Izobraževalno gradivo za zdravstvene delavce mora vključevati informacije o naslednjih ključnih elementih:
Among 15 subjects treated with open-label Cinryze for laryngeal HAE attacks, none required intubation.
Pri nobenem od 15 preiskovancev, zdravljenih z odprtim zdravilom Cinryze za laringealne napade HAE, ni bila potrebna intubacija.
Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.
Rutinsko preprečevanje napadov angioedema pri odraslih, mladostnikih in otrocih (starih 6 let in več) s hudimi in ponavljajočimi se napadi dednega angioedema (HAE), ki ne prenašajo peroralnih zdravil za preprečevanje ali jih ta zdravila ne zaščitijo dovolj, ali pri bolnikih, pri katerih ponavljajoče se akutno zdravljenje ne zadostuje.
The expected consequence of metabolism of a glycoprotein is via degradation to small peptides and individual amino acids.
Za glikoprotein pričakujemo, da se presnavlja z degradacijo v majhne peptide in posamezne aminokisline.
Based upon an animal study there is a potential thrombogenic threshold at doses greater than 200 Units
Sodeč po študiji na živalih je možen trombogeni prag pri odmerkih nad 200 enot(*)/kg.
As with any biological product hypersensitivity reactions may occur.
Podobno kot pri drugih bioloških zdravilih lahko nastopijo preobčutljivostne reakcije.
Mean Pharmacokinetic Parameters for Functional C1 Inhibitor Following Administration of Cinryze
Povprečni farmakokinetični parametri za funkcionalni zaviralec C1 po uporabi zdravila Cinryze
In adults and children, Cinryze can raise the amount of C1 inhibitor in the blood and either prevent (prior to undergoing medical or dental procedures) these swelling attacks from occurring or stop swelling attacks once they have begun.
Pri odraslih in otrocih lahko zdravilo Cinryze zviša koncentracijo zaviralca C1 v krvi in bodisi prepreči (pred medicinskimi ali zobozdravstvenimi posegi), da bi se ti napadi otekanja pojavljali, bodisi tak napad zaustavi, če se je že začel.
Do not remove the device from the package.
Ne vzemite priprave iz pakiranja.
Because these pathways are part of enzyme amplification cascades, without C1 inhibitor, spontaneous or trigger-induced activation of these pathways can lead to unopposed activation and swelling.
Ker so te presnovne poti del encimskih ojačevalnih kaskad, lahko spontana ali s sprožilcem povzročena aktivacija teh presnovnih poti brez zaviralca C1 povzroči neovirano aktivacijo in otekanje.
You or your carer might also administer Cinryze as an injection, but only after receiving adequate training.
Zdravilo Cinryze si lahko injicirate tudi sami ali vam ga injicira vaš negovalec, vendar le po tem, ko se ustrezno izobrazita.
Each product vial should be reconstituted with 5 ml water for injections.
Vsako vialo z zdravilom rekonstituirajte s 5 ml vode za injekcije.
Cinryze for the pre-procedure prevention of HAE attacks Open-label Cinryze was administered within 24 hours prior to a total of 91 medical, dental, or surgical procedures across the clinical programme (40 procedures in children and 51 procedures in adults).
Zdravilo Cinryze za preoperativno preprečevanje napadov HAE Odprto zdravilo Cinryze so uporabili največ 24 ur pred vsega skupaj 91 medicinskimi, stomatološkimi ali operativnimi posegi v spektru kliničnega programa (40 posegov pri otrocih in 51 posegov pri odraslih).
The educational material for non-healthcare professionals should include information on the following key elements:
Izobraževalno gradivo za osebe, ki niso zdravstveni delavci, naj obsega informacije o naslednjih ključnih elementih:
C1 inhibitor inhibits the complement system by binding C1r and C1s, two of the active enzyme subunits of the first component of the complement system (C1) in the classical pathway, as well as to mannose-binding lectin-associated serine proteases in the lectin pathway.
Zaviralec C1 zavira sistem komplementa, tako da veže C1r in C1s, dve od aktivnih encimskih podenot prve komponente sistema komplementa (C1) v klasični presnovni poti, pa tudi z lektinom povezane serinske proteaze, ki vežejo manozo, v lektinski presnovni poti.
If your doctor decides you can selfadminister, your doctor or nurse will train you or a family member to prepare and inject Cinryze.
Če se bo zdravnik odločil, da si lahko zdravilo dajete sami, bo on ali medicinska sestra naučil vas ali vašega družinskega člana pripravljati in injicirati zdravilo Cinryze.
Regular review of your/your carer's injection technique will be performed to ensure continued appropriate handling.
Zdravnik bo tudi redno ocenjeval vašo tehniko injiciranja oziroma tehniko injiciranja vašega negovalca, da bo zagotovljeno stalno ustrezno ravnanje z zdravilom.
Each vial of Cinryze contains approximately 11.5 mg of sodium.
Ena viala zdravila Cinryze vsebuje približno 11,5 mg natrija.
Ensure the powder vial and the solvent vial are at room temperature (15ºC - 25ºC).
Poskrbite, da bosta viala s praškom in viala z vehiklom segreti na sobno temperaturo (15 ºC - 25 ºC).
• Cinryze should be injected intravenously (into the vein).
• Zdravilo Cinryze se mora injicirati intravensko (v veno).
Your treatment will be initiated and managed under supervision of a doctor experienced in the care of patients with hereditary angioedema (HAE).
Vaše zdravljenje bo začel, vodil in nadzoroval zdravnik, ki ima izkušnje z zdravljenjem bolnikov z dednim angioedemom (HAE - hereditary angioedema).
• For patients experiencing laryngeal attacks or if initiation of treatment is delayed, the second dose can be given sooner than 60 minutes.
• Pri bolnikih, ki imajo laringealne napade, in v primerih, ko je zdravljenje uvedeno z zamudo, smemo dati drugi odmerek prej kot po 60 minutah.
Other medicines and Cinryze
Druga zdravila in zdravilo Cinryze
Double Dose (1000 Units dose followed by a second 1000 Units dose 60 minutes later)
Dvojni odmerek (odmerek 1000 enot, čez 60 minut še en odmerek 1000 enot)
After intravenous administration of a single dose of Cinryze to HAE subjects, the serum concentration of functional C1 inhibitor doubled within 1 to 2 hours.
Po intravenski aplikaciji enkratnega odmerka zdravila Cinryze preiskovancem s HAE se je serumska koncentracija funkcionalnega zaviralca C1 v 1 do 2 urah podvojila.
In adults, adolescents and children (aged 6 years and above), Cinryze can raise the amount of C1 inhibitor in the blood and routinely prevent swelling attacks from occurring.
Pri odraslih, mladostnikih in otrocih (starih 6 let in več) lahko zdravilo Cinryze zviša koncentracijo zaviralca C1 v krvi in rutinsko preprečuje napade otekanja.
Single Dose (1000 Units*)
Enkraten odmerek (1000 enot*)
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived C1 inhibitor product.
Primerno cepljenje (proti hepatitisu A in B) pride v poštev za bolnike, ki redno/ponovno prejemajo zdravilo z zaviralcem C1, izdelanim iz humane plazme.
Study LEVP 2006-4: Prior to enrollment, 23 children (age range: 3 to 17 years) reported a median monthly HAE attack rate of 3.0 (range: 0.5-28.0).
Študija LEVP 2006-4: Pred vključitvijo v študijo je 23 otrok (razpon starosti: 3 do 17 let) poročalo o mediani mesečni pogostnosti napadov HAE 3,0 (razpon: 0,5-28,0).
Aseptic technique should be used during the reconstitution procedure.
Med postopkom rekonstituiranja uporabljajte aseptično tehniko.
Uncommon side effects (may affect up to 1 in 100 people): high blood sugar, blood clot, painful veins, hot flush, cough, stomach pain, diarrhoea, skin flaking, joint swelling and pain, muscle pain, and chest discomfort.
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): zvišan krvni sladkor, krvni strdek, bolečina v venah, vročinski oblivi, kašelj, bolečine v trebuhu, driska, luščenje kože, otekanje sklepov in mišic, bolečine v mišicah in bolečine v prsnem košu.
What Cinryze is and what it is used for What you need to know before you take Cinryze How to take Cinryze
Kaj je zdravilo Cinryze in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cinryze Kako jemati zdravilo Cinryze Možni neželeni učinki
Reconstitution, product administration and handling of the administration set and needles must be done with caution.
Pri rekonstituciji, uporabi zdravila in ravnanju s kompletom za dajanje zdravila in iglami je potrebna pazljivost.
Only use a silicone-free syringe (provided in the pack) for administration of the product.
Za dajanje zdravila uporabljajte samo injekcijske brizge brez silikona (na voljo v pakiranju).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Proceed to administration process if patients receive a dose of 500 IU.
Nadaljujte s postopkom dajanja zdravila, če bolniki prejmejo odmerek 500 i.e.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B and hepatitis C viruses, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Menimo, da so storjeni ukrepi učinkoviti za viruse z ovojnico, na primer virus humane imunske pomanjkljivosti (HIV) in virusa hepatitisa B in hepatitisa C, in za gole viruse, kot sta virus hepatitisa A in parvovirus B19.
In open-label study LEVP 2006-4, 146 subjects received Cinryze as HAE prophylaxis for periods ranging from 8 days to approximately 32 months (median 8 months).
V odprti študiji LEVP 2006-4 je 146 preiskovancev prejelo zdravilo Cinryze za profilakso HAE za čas od 8 dni do približno 32 mesecev (mediana 8 mesecev).
Cinryze has minor influence on the ability to drive and use machines.
Zdravilo Cinryze ima blag vpliv na sposobnost upravljanja vozil in strojev.
Once reconstituted, Cinryze solution should be used immediately.
Po rekonstituciji je treba raztopino zdravila Cinryze uporabiti takoj.
In open-label study LEVP 2006-1, 101 subjects were treated for a total of 609 acute HAE attacks (median 3 attacks per subject; range: 1-57).
V odprti študiji LEVP 2006-1 je bil 101 preiskovanec zdravljen zaradi vsega skupaj 609 akutnih napadov HAE (mediana 3 napadi na preiskovanca; razpon: 1-57).
• If you are experiencing a severe attack, particularly a swelling of the voice-box (larynx), or if initiation of treatment is delayed, the second 1000 IU dose may be given earlier than 60 minutes after the first dose, depending on your clinical response.
• Če dobite hud napad, posebno otekanje grla (larinksa), in v primerih, ko je začetek zdravljenja prestavljen, lahko prejmete drugi odmerek 1000 i.e. prej kot 60 minut po prvem odmerku,
Like all medicines, Cinryze can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Reconstitution and method of administration
Rekonstitucija in način uporabe
• 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.
• 1000 i.e. zdravila Cinryze vsake 3 ali 4 dni je priporočeni začetni odmerek za preprečevanje napadov angioedema; presledek med odmerki po potrebi prilagodite individualnemu odzivu.
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).
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).
Inspect the reconstituted Cinryze solution for particulate matter prior to administration; do not use if particles are observed.
Pred dajanjem rekonstituirano raztopino zdravila Cinryze preglejte, ali vsebuje delce, in je ne uporabite, če opazite delce.
Among 84 separate laryngeal HAE attacks, none required intubation following treatment with Cinryze.
Od 84 posameznih laringealnih napadov HAE ni bila po zdravljenju z zdravilom Cinryze pri nobenem potrebna intubacija.
Cinryze is a white powder contained in a vial.
Zdravilo Cinryze je bel prašek v viali.
dental, or surgical procedure.
stomatološkim ali kirurškim posegom.
The educational pack should contain the following:
Izobraževalni paket mora vsebovati:
Do not take Cinryze
Ne jemljite zdravila Cinryze
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.
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.
Do not shake the powder vial.
Viale s praškom ne stresajte.
Therefore, repeat instructions 1 to 12 above using an additional package containing a transfer device to reconstitute the second of two powder vials.
Zato ponovite zgornje korake 1 do 12 in uporabite dodatno pakiranje s pripravo za prenos, da boste rekonstituirali drugo vialo s praškom.
subjects (>25 kg) 1500 Units
(> 25 kg) 1000 enot in 3 preiskovanci (> 25 kg) 1500 enot
Adverse reactions to treatment with Cinryze are classified by MedDRA System Organ Class and absolute frequency in Table 1.
Neželeni učinki zdravljenja z zdravilom so v preglednici 1 razvrščeni po organskih sistemih po MedDRA in po absolutni pogostnosti.
[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.]
[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.]
What Cinryze looks like and contents of the pack
Izgled zdravila Cinryze in vsebina pakiranja
It is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Cinryze
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.
The vacuum in the powder vial will draw in the solvent.
Vakuum v viali s praškom bo vsrkal vehikel.
Remove plastic caps from the powder and solvent vials.
Odstranite plastična pokrovčka z vial s praškom in vehiklom.
Cinryze is intended for intravenous administration after reconstitution with water for injections.
Zdravilo Cinryze je namenjeno za intravensko uporabo po rekonstituciji z vodo za injekcije.
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).
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).
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Kljub tem ukrepom pri uporabi zdravil, pripravljenih iz humane krvi ali plazme, ni mogoče popolnoma izključiti možnosti prenašanja okužb.
Cinryze for the treatment of HAE attacks
Zdravilo Cinryze za zdravljenje napadov HAE
Prevention of swelling attacks prior to surgery
Preprečevanje napadov otekanja pred operacijo
500 IU of Cinryze every 3 or 4 days is the recommended starting dose for routine prevention against angioedema attacks.
500 i.e. zdravila Cinryze vsake 3 ali 4 dni je priporočeni začetni odmerek za rutinsko preprečevanje napadov angioedema.
Do not use the product if the solutions are turbid or discoloured.
Ne uporabite zdravila, če je katera od raztopin motna ali obarvana.
A leaflet providing detailed information on the key elements of the training that should be kept at home for further reference.
Bolnik naj doma hrani navodilo s podrobnostmi glede ključnih elementov izobraževanja zaradi nadaljnjih napotkov.
Cinryze is intended for intravenous administration (into the vein) after reconstitution with water for injections.
Zdravilo Cinryze je namenjeno za intravensko uporabo (v veno) po rekonstituciji z vodo za injekcije.
tmax (hr) [median (range)]
tmaks (h) [mediana (razpon)]
Non-clinical data reveal no special hazard for humans based on conventional studies of general toxicity and toxicity to reproduction.
Predklinični podatki na osnovi običajnih študij splošne toksičnosti in toksičnosti za razmnoževanje ne kažejo posebnega tveganja za človeka.
There are limited data on the use of this medicinal product in home or self-administration.
Podatkov o uporabi tega zdravila na domu ali o samozdravljenju je malo.
The active substance is C1 inhibitor produced from the plasma of human donors.
Zdravilna učinkovina je zaviralec C1, izdelan iz plazme človeških dajalcev.
Cinryze therapy should be initiated under supervision of a physician experienced in the care of patients with hereditary angioedema (HAE).
Zdravljenje z zdravilom Cinryze se mora uvesti pod nadzorstvom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z dednim angioedemom (HAE).