natgillin/translations-raw huggingface dataset:
A doctor or nurse may prepare and inject Cinryze for you.
Zdravilo Cinryze bo za vas najbrž pripravil in vam ga injiciral zdravnik ali medicinska sestra.
Once the two vials are reconstituted proceed to administration process for a dose of 1000 IU
Ko sta viali rekonstituirani, nadaljujte s postopkom dajanja zdravila za odmerek 1000 i.e.
• 1000 IU of Cinryze at the first sign of the onset of an angioedema attack.
• 1000 i.e. zdravila Cinryze pri prvem znaku začetka napada angioedema.
Very common Nausea Common vomiting Uncommon Diarrhoea, abdominal pain
Bolezni prebavil zelo pogosti navzea pogosti bruhanje občasni driska, bolečine v trebuhu
Baseline-corrected AUC(0-t) (U*hr/ml)
na izhodišče popravljena AUC(0-t) (e*h/ml)
Date and time of treatment
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously (into the vein) into the patient.
Na brizgo, ki vsebuje raztopino zdravila Cinryze, pritrdite komplet za punkcijo vene in intravensko (v veno) injicirajte vsebino brizge bolniku.
The mean pharmacokinetic parameters for functional C1 inhibitor derived from baseline-corrected concentration data are presented in Table 2.
, 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.
Cmax (U/ml)
Cmaks (e/ml)
Powder vial: sodium chloride, sucrose, sodium citrate, L-valine, L-alanine, L-threonine Solvent vial: water for injections
Viala s praškom: natrijev klorid, saharoza, natrijev citrat, L-valin, L-alanin, L-treonin.
Cinryze contains sodium
Zdravilo Cinryze vsebuje natrij
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.
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.
Two vials of reconstituted Cinryze contain 1000 IU of C1 inhibitor (human) per 10 ml, corresponding to a concentration of 100 IU/ml.
Dve viali rekonstituiranega zdravila Cinryze vsebujeta 1000 i.e. zaviralca C1 (humanega) na 10 ml, kar ustreza koncentraciji 100 i.e./ml.
Venous thrombosis, phlebitis, venous burning, hot flush
Žilne bolezni občasni venska tromboza, flebitis, občutek pečenja v veni, vročinski oblivi
2 filter transfer devices, 2 disposable 10 ml syringes, 2 venipuncture sets, and 2 protective mats.
2 pripravi za prenos s filtrom, 2 10-mililitrski brizgi za enkratno uporabo, 2 kompleta za punkcijo vene, 2 zaščitni podlogi.
1000 IU of Cinryze at the first sign of the onset of an acute attack.
1000 i.e. zdravila Cinryze pri prvem znaku začetka akutnega napada.
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
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.
Administration process for a dose of 500 IU
Postopek dajanja zdravila za odmerek 500 i.e.
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.
Bolniku dajte 500 i.e. (rekonstituiranih v 5 ml vode za injekcije) zdravila Cinryze intravensko s hitrostjo 1 ml na minuto v 5 minutah.
The information collected should include:
Zagotovljeno izobraževanje mora vsebovati naslednje elemente:
Attach the venipuncture set to the syringe containing Cinryze solution and inject intravenously into the patient.
Na brizgo, ki vsebuje raztopino zdravila Cinryze, pritrdite komplet za punkcijo vene in intravensko injicirajte vsebino brizge bolniku.
The existence of a post marketing registry in which health care professionals are encouraged to enter patients
Zdravstvene delavce naj se spodbudi k vpisu bolnikov v register.
Cinryze based on body weight (see section 5.1).
, 1000 enot ali 1500 enot zdravila Cinryze glede na telesno maso (glejte poglavje 5.1).
Detach the syringe from the vial by turning it anti-clockwise and releasing it from the clear end of the transfer device.
Ločite brizgo od viale tako, da jo zasukate v smeri urnega kazalca in jo snamete s prozornega konca priprave za prenos.
Treatment of swelling attacks
Zdravljenje napadov otekanja
Therefore two vials are combined for one dose of 1000 IU.
Zato za en odmerek 1000 i.e. združite dve viali.
Release the powder vial label by tearing down the perforated strip indicated by the inverted triangle.
Z viale s praškom strgajte perforirani trak, kot nakazuje obrnjen trikotnik, da postane vidna oznaka.
A dose of 500 IU (one vial) of Cinryze should be injected every 3 or 4 days for routine prevention of swelling attacks.
Za rutinsko preprečevanje napadov otekanja je treba injicirati odmerek 500 i.e. (eno vialo) zdravila Cinryze vsake 3 ali 4 dni.
A second dose of 500 IU may be administered if the patient has not responded adequately after 60 minutes.
Drugi odmerek 500 i.e. se sme aplicirati, če se bolnik v 60 minutah po prvem odmerku ne odzove primerno.
Two vials of reconstituted Cinryze are combined for a single dose.
Za enkraten odmerek morate združiti dve viali rekonstituiranega zdravila Cinryze.
Cinryze for the routine prevention of HAE attacks
Zdravilo Cinryze za preprečevanje napadov HAE
Age-group <6years: For the 3 subjects less than 6 years, administration of Cinryze (500 Units or 1000 Units
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.
A second dose of 1000 IU may be administered if the patient has not responded adequately after 60 minutes.
Drugi odmerek 1000 i.e. se sme aplicirati, če se bolnik v 60 minutah po prvem odmerku ne odzove primerno.
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.
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.
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.
Bolniku dajte 1000 i.e. (rekonstituiranih v 10 ml vode za injekcije) zdravila Cinryze intravensko s hitrostjo 1 ml na minuto v 10 minutah.
One vial of reconstituted Cinryze contains 500 IU of C1 inhibitor in 5 ml, resulting in a concentration of 100 IU/ml.
Ena viala rekonstituiranega zdravila Cinryze vsebuje 500 i.e. zaviralca C1 v 5 ml, koncentracija je 100 i.e. /ml.
• A second dose of 1000 IU may be administered if the patient has not responded adequately after 60 minutes.
• Drugi odmerek po 1000 i.e. smemo dati, če se bolnik 60 minut po prvem odmerku ne odzove primerno.
CARTON
Usin
Baseline-corrected Cmax (U/ml)
na izhodišče popravljena Cmaks (e/ml)
Very common headache Common
Bolezni živčevja zelo pogosti glavobol pogosti omotičnost
Two solvent vials.
2 viali z vehiklom,
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.
Pritiskajte navzdol, dokler konica ne prodre skozi sredino zamaška viale z vehiklom in priprava ne zdrsne na svoje mesto.
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.
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.
How to store Cinryze
Shranjevanje zdravila Cinryze
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.
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.
Indication for treatment (acute attack or prophylaxis) Response to treatment
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.
All 9 (100%) subjects achieved unequivocal beginning of relief of the defining symptom within 4 hours following initiation of treatment with Cinryze.
4 urah po začetku zdravljenja z zdravilom Cinryze doseglo nedvoumen nastop olajšanja simptoma, ki opredeljuje napad HAE.
Uncommon Joint swelling, arthralgia, myalgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni otekanje sklepov, artralgija, mialgija
Remove the plastic package from the transfer device and discard it. Take care not to touch the exposed end of the transfer device.
Odstranite plastični omot s priprave za prenos in ga zavrzite.
After reconstitution, one vial contains 500 IU of C1 inhibitor (human) per 5 ml, corresponding to a concentration of 100 IU/ml.
Po rekonstituciji ena viala vsebuje 500 i.e. zaviralca C1 (humanega) na 5 ml, kar ustreza koncentraciji 100 i.e. /ml.
Immune system disorders
Bolezni imunskega sistema pogosti preobčutljivost
A dose of 1000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical, dental, or surgical procedure.
Predoperativno preprečevanje napadov angioedema • 1000 i.e. zdravila Cinryze 24 ur pred internističnim, stomatološkim ali kirurškim posegom.
to prevent capillary leak syndrome.
/kg) za preprečevanje sindroma zvečane prepustnosti kapilar med posegi na srcu z zunajtelesnim krvnim obtokom.
The transfer device must be vertical prior to penetrating the stopper closure.
Preden priprava predre zamašek, mora biti v navpični legi.
Disconnect the solvent vial by turning it anti-clockwise.
Ločite vialo z vehiklom od priprave za prenos, tako da jo zasukate v nasprotni smeri urnega kazalca.
Metabolism and nutrition disorders
Presnovne in prehranske motnje občasni hiperglikemija
/kg.
• spolovil.
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
Za en odmerek (1000 i.e. /10 ml) morate rekonstituirati dve viali praška Cinryze.
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.
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.
The instructions include the following main steps:
Navodila vključujejo naslednje glavne korake:
An attack usually lasts between 2 to 5 days.
Napad običajno traja 2 do 5 dni.
Important information for healthcare professionals and caregivers:
Pomembne informacije za zdravstvene delavce in negovalce:
ATC code: B06AC02.
oznaka ATC: B06AC02.
(Unknown)
(neznana)
The time to maximum concentration is approximately 30 minutes.
Čas do maksimalne koncentracije je približno 30 minut.
When and how often should you use Firazyr?
Kdaj in kako pogosto smete uporabljati zdravilo Firazyr?
No therapeutic intervention was necessary.
Terapevtski ukrepi niso bili potrebni.
All patients maintained efficacy.
Pri vseh bolnikih se je učinkovitost vzdrževala.
System Organ Class (incidence category)
Organski sistem (kategorija incidence)
1) General Information
1) Splošne informacije
The terminal plasma half-life is about 1-2 hours.
Končna razpolovna doba v plazmi je približno 1-2 uri.
Date of first authorisation: 11 July 2008 Date of latest renewal: 13 March 2013
Datum zadnjega podaljšanja: 13. marec 2013
Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used.
Vaš zdravnik je določil natančen odmerek zdravila Firazyr in vam bo povedal, kako pogosto ga smete uporabljati.
38 Number of subjects in ITT Population 27
38 Število oseb v ITT
Each syringe should only be used once.
Vsaka brizga se lahko uporabi samo enkrat.
Information on individual race effect is limited.
Informacije o učinku pri posameznih rasah so omejene.
Efficacy data were obtained from an initial open-label Phase II study and from three controlled Phase III studies.
Podatki o učinkovitosti so bili pridobljeni iz začetne odprte študije faze II in iz treh kontroliranih študij faze III.
Patients should be advised not to drive and use machines if they feel tired or dizzy.
Bolnike je treba opozoriti, da ne vozijo in upravljajo s stroji, če so utrujeni ali omotični.
It is a synthetic decapeptide with a structure similar to bradykinin, but with 5 non-proteinogenic amino acids.
To je sintetični dekapeptid s podobno strukturo kot bradikinin, vendar s 5 neproteionogenimi aminokislinami.
Clearance is about 15-20 l/h and independent of dose.
Očistek je približno 15-20 l/h in je neodvisen od odmerka.
Table 3 shows the efficacy results for these studies.
Tabela 3 vsebuje rezultate teh študij za učinkovitost.
The frequency of adverse reactions listed in Table 1 is defined using the following convention:
Pogostnost neželenih učinkov, ki so navedeni v Preglednici 1, je opredeljena v skladu z naslednjim dogovorom:
- You should not have more than 3 injections in a 24 hour period and if you require more than 8 injections in a month, you should seek medical advice.
- V 24-urnem obdobju smete prejeti največ 3 injekcije, če potrebujete več kot 8 injekcij v enem mesecu, pa se morate posvetovati z zdravnikom.
Limited information is available on patients older than 65 years of age.
O uporabi pri bolnikih, starejših od 65 let, ni na voljo zadostnih informacij.
92.4% of these attacks of HAE were treated with a single dose of Firazyr.
92,4 % napadov HAE so zdravili z enkratnim odmerkom zdravila Firazyr.
Do not throw away any medicines via waste water or household waste.
Zdravila ne odvrzite v odpadne vode ali med gospodinjske odpadke.
Icatibant is a selective competitive antagonist at the bradykinin type 2 (B2) receptor.
Ikatibant je selektivni kompetitivni antagonist na receptorju za bradikinin tipa 2 (B2).
- If you are allergic to icatibant, or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na ikatibant ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
Placebo p-value
Placebo vrednost p
Two paediatric patients experienced injection site reactions which were assessed as severe and which were completely resolved within 6 hours.
Pri dveh pediatričnih bolnikih so se pojavile reakcije na mestu injiciranja, ki so jih ocenili kot hude, ki pa se popolnoma izginile v 6 urah.
• Adapter (proximal and/or distal female luer lock connector/coupler)
• vmesnik (proksimalni in/ali distalni ženski priključek/spoj Luer lock);
Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Ne uporabljajte tega zdravila, če opazite da je ovojnina brizge ali igle poškodovana ali če so vidni znaki kvarjenja, na primer, če je raztopina motna, če v njej plavajo delci ali če se je spremenila barva raztopine.
(Very Common, ≥1/10)
(zelo pogosti, ≥1/10)
• Press slowly so that this takes approximately 30 seconds.
• Bat potiskajte počasi, tako da injiciranje traja približno 30 sekund.
Available exposure data suggest no difference in the clearance between non-White (n=40) and White (n=132) subjects.
Razpoložljivi podatki o izpostavljenosti kažejo, da razlik v očistku med preskušanci bele rase (n = 132) in pripadniki drugih ras (n = 40) ni.
It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Firazyr, should not breastfeed for 12 hours after treatment.
Ni znano, ali se ikatibant pri ljudeh izloča v materino mleko, vendar je priporočljivo, da doječe matere, ki želijo uporabiti zdravilo Firazyr, 12 ur po uporabi zdravila ne dojijo.
For adults, subsequent doses that may be required for the same attack should be administered within a medical institution (see section 4.2).
Pri odraslih je treba nadaljnje odmerke, ki so morda potrebni pri istem napadu, dajati v zdravstveni ustanovi (glejte poglavje 4.2).
Results do not indicate a carcinogenic potential for icatibant.
Rezultati ne nakazujejo karcinogenega potenciala ikatibanta.
In vitro studies have confirmed that icatibant is not degraded by oxidative metabolic pathways and is not an inhibitor of major cytochrome P450 (CYP) isoenzymes (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4) and is not an inducer of CYP 1A2 and 3A4.
Študije in vitro so potrdile, da se ikatibant ne razgrajuje po oksidacijskih presnovnih poteh ter da ni zaviralec glavnih izoencimov citokroma P450 (CYP) (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4) in ni induktor CYP 1A2 in 3A4.
Do not choose an area that is bruised, swollen, or painful.
Ne izberite mesta s podplutbami, oteklino ali bolečino.
No clinically significant changes in reproductive hormones were observed during clinical studies.
V kliničnih študijah niso opazili klinično pomembnih sprememb reproduktivnih hormonov.
Icatibant volume of distribution (Vss) is about 20-25 L. Plasma protein binding is 44%.
Volumen porazdelitve (Vss) ikatibanta je približno 20-25 l. Vezava na plazemske proteine je 44 %.
Subsequent episodes of HAE were treated in an open label extension.
Nadaljnje epizode HAE so zdravili v odprti razširjeni študiji.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans is unknown.
Študije na živalih so pokazale učinke na ugnezdenje v maternico in kotenje (glejte poglavje 5.3), vendar pa možno tveganje za ljudi ni znano.
• The syringe is now ready for injection.
• Brizga je pripravljena za injiciranje.
In a standard battery of in vitro and in vivo tests icatibant was not genotoxic.
V standardnem nizu in vitro in in vivo preizkusov ikatibant ni bil genotoksičen.
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less:
2a) Priprava brizge za otroke in mladostnike (2-17 let), ki tehtajo 65 kg ali manj
The relevance of this to the safety of Firazyr is unknown (see section 5.2).
Pomen tega dejstva za varnost zdravila Firazyr ni znan (glejte poglavje 5.2).
Under ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2.
Pri ishemičnih stanjih je poslabšanje srčne funkcije in zmanjšanja koronarnega pretoka teoretično lahko posledica antagonizma na receptorju za bradikinin tipa 2.
These tissue findings were consistent with reported effects on gonadotrophins and during the subsequent treatment-free period appear to be reversible.
Te ugotovitve na tkivu so bile skladne s poročanimi učinki na gonadotropine in so bile reverzibilne v poznejšem obdobju brez zdravljenja.
Data suggest that there is no difference in the clearance between females and males after correcting for body weight.
Spol Podatki kažejo, da ni bilo razlik pri očistku pri ženskah in moških po popravku za telesno maso.
Similar effects of icatibant on reproductive tissue were seen in sexually mature rats and dogs.
Podobne učinke ikabitanta na reproduktivno tkivo so opazili pri spolno zrelih podganah in psih.
No dosage regimen for children aged less than 2 years or weighing less than 12 kg can be recommended as the safety and efficacy in this paediatric group has not been established.
Pri otrocih, mlajših od 2 let ali s telesno maso 12 kg ali manj, ni mogoče priporočiti režima odmerjanja, saj niso ugotovili varnosti in učinkovitosti v tej pediatrični skupini.
Avoid touching the ends of the connector and syringe tips, to prevent contamination
Ne dotikajte se koncev vmesnika in konic brizg, da preprečite kontaminacijo.
• Make sure that there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle.
• Prepričajte se, da v brizgi ni nobenih zračnih mehurčkov, tako da potiskate bat, dokler se na konici igle ne pojavi prva kapljica.
A total of 237 patients were treated with 1,386 doses of 30 mg icatibant for 1,278 attacks of acute HAE.
Skupno 237 bolnikov so zdravili z 1386 odmerki 30 mg ikatibanta zaradi 1278 napadov akutnega HAE.
Data suggest an age-related decline in clearance resulting in about 50-60% higher exposure in older people (75-80 years) compared to patients aged 40 years.
Podatki nakazujejo, da se očistek s starostjo zmanjšuje, kar pomeni, da je pri starejših (75-80 let) izpostavljenost za 50-60 % večja kot pri bolnikih, starih 40 let.
Eleven patients were of prepubertal status and 21 patients were either pubertal or postpubertal.
Enajst bolnikov je bilo v predpuberteti, 21 bolnikov pa je bilo v puberteti ali postpuberteti.
The dosing regimen used for this study is unlikely to be sustained in the clinical setting.
Režim odmerjanja, ki je bil uporabljen v tej študiji, bi bilo težko izvajati v kliničnem okolju.
These effects are usually mild and clear up without the need for any additional treatment.
Ti učinki so navadno blagi in izginejo brez dodatnega zdravljenja.
Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).
Bolniki, ki tehtajo več kot 65 kg, morajo prejeti celotno vsebino napolnjene injekcijske brizge (3 ml).
This patient was followed for 5 months and further samples were negative for anti-icatibant antibodies.
Pri tem bolniku so 5 mesecev opravljali sledenje, pri čemer so bili nadaljnji vzorci negativni za protitelesa proti ikatibantu.
• Push the plunger of the graduated syringe so that any air is transferred back into the pre-filled syringe (this step may need to be repeated several times).
• Potisnite bat brizge z oznakami za prostornino, tako da se ves zrak potisne nazaj v napolnjeno injekcijsko brizgo (ta korak boste morda morali ponoviti večkrat).
Icatibant has been shown to aggravate induced cardiac ischemia in several non-clinical models, although a detrimental effect has not consistently been shown in acute ischemia.
Izkazalo se je, da je ikatibant poslabšal inducirano ishemično bolezen srca pri mnogih nekliničnih modelih, čeprav se škodljiv učinek ni vedno kazal v akutni ishemiji.