natgillin/translations-raw huggingface dataset:
- Rash (including allergic dermatitis and rash erythematous)
- izpuščaj (vključno z alergijskim dermatitisom in eritematoznim izpuščajem)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse, hamster or bovine protein.
Preobčutljivost na učinkovino, katero koli pomožno snov, ki je navedena v poglavju 6.1, ali mišje,
Factor VII deficiency
Pomanjkanje faktorja VII
Limited clinical experience in long term prophylaxis has been gathered in the paediatric population below 12 years of age, with a severe clinical phenotype (see section 5.1).
Pediatrična populacija Pridobljene klinične izkušnje v dolgotrajni profilaksi v pediatrični populaciji, mlajši od 12 let in s hudim kliničnim fenotipom, so omejene (glejte poglavje 5.1).
• Repeat the procedure with the appropriate number of additional vials, solvent vials/pre-filled syringes and vial adapters.
• Postopek ponovite z ustreznim številom dodatnih vial, vial/napolnjenih injekcijskih brizg topila in nastavkov za vialo.
- Pyrexia
- pireksija
Data from non-clinical studies as well as post-marketing data show no indication that rFVIIa has a harmful effect on male or female fertility.
Podatki predkliničnih študij kot tudi izkušnje po prihodu zdravila na trg ne kažejo, da bi rFVIIa škodljivo vplival na plodnost moških ali žensk.
Ensure that the syringe, the infusion tube and the in-line filter are primed and free of air before administration.
Poskrbite, da so brizga, infuzijska cevka in linijski filter pred uporabo ustrezno pripravljeni in ne vsebujejo zraka.
Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 53 ml/h×kg), whereas the mean terminal half-life was determined to 2.3 hours in both groups.
Povprečni očistek je bil pri pediatričnih bolnikih približno 50 % večji kot pri odraslih (78 v primerjavi s 53 ml/h×kg), ugotovljeni povprečni terminalni razpolovni čas pa je bil v obeh skupinah 2,3 ure.
• Use NovoSeven at once after mixing the powder with the solvent to avoid infection.
• Zdravilo NovoSeven uporabite takoj potem, ko prašek zmešate s topilom, da boste preprečili okužbo.
After reconstitution, chemical and physical stability has been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Po pripravi je kemična in fizikalna stabilnost dokazana za 6 ur pri temperaturi 25 °C in 24 ur pri temperaturi 5 °C.
If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and should not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila priprava opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Do not disassemble the equipment before disposal.
Ne razstavljajte opreme, preden jo zavržete.
However, there is no medical reason to think that it would affect your ability.
Vendar ni zdravstvenih razlogov, zaradi katerih bi lahko pričakovali, da bo to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
Locate a suitable site, and slowly inject NovoSeven into a vein over a period of 2 - 5 minutes without removing the needle from the injection site.
Poiščite primerno mesto in počasi, od 2 do 5 minut, injicirajte zdravilo NovoSeven v veno, ne da bi iglo odstranili z mesta injiciranja.
Haemophilia A or B with inhibitors or expected to have a high anamnestic response
Hemofilija A ali B z zaviralci ali pričakovanim velikim anamnestičnim odzivom
2) One single injection of 270 µg per kg body weight.
2) Ena posamična injekcija 270 µg na kg telesne mase.
- Flushing - Angioedema
- zardevanje - angioedem
There is no clinical experience in people over 65 using this single dose.
Kliničnih izkušenj z uporabo tega posamičnega odmerka pri bolnikih, starejših od 65 let, ni.
Follow the injection procedure as instructed by your healthcare professional.
Pri tem se držite navodil za injiciranje, ki ste jih dobili od vašega zdravstvenega osebja.
Do not touch the rubber stopper after wiping it.
Ne dotikajte se gumijastega zamaška, potem ko ste ga obrisali.
Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet in proizvajalec
Unscrew the empty syringe from the vial adapter and for both presentations ensure that a vial adapter is attached to the vial containing reconstituted product.
Odvijte prazno brizgo z nastavka viale in za obe obliki zdravila poskrbite, da je na viali, ki vsebuje pripravljeno zdravilo, nameščen nastavek za vialo.
If such symptoms occur, the patient should be advised to discontinue use of the product immediately and contact their physician.
Bolniku je treba naročiti, da mora v primeru pojava takšnih simptomov nemudoma prenehati uporabljati zdravilo in se mora posvetovati z zdravnikom.
For those patients who are not refractory, platelets is the first line treatment for Glanzmann's thrombasthenia.
Pri bolnikih, ki niso refraktarni, so prva izbira zdravljenja Glanzmannove trombastenije trombociti.
Dose and dose interval
Odmerek in odmerni interval
Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Hallas Allé DK-4400 Kalundborg
• Reconstitute the product as described above under Reconstitution for relevant product presentation.
• Zdravilo pripravite, kot je opisano zgoraj pod naslovom Rekonstitucija za relevantne farmacevtske oblike zdravila.
Vial: Type I glass vial closed with a chlorobutyl rubber stopper, covered with an aluminium cap.
Viala: viala iz stekla tipa I, zaprta z zamaškom iz klorobutilne gume, prekritim z aluminijastim pokrovčkom.
Because of the risk of thromboembolic complications, caution should be exercised when administering NovoSeven to patients with a history of coronary heart disease, to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation.
Zaradi tveganja trombemboličnih zapletov morate zdravilo NovoSeven uporabljati previdno pri bolnikih z anamnezo koronarne bolezni, bolnikih z boleznijo jeter, bolnikih po operacijah, novorojenčkih in pri bolnikih, pri katerih obstaja tveganje za trombembolične pojave ali diseminirano intravaskularno koagulacijo.
• Allergic skin reactions including rash, itching and hives
• alergijske kožne reakcije, vključno z izpuščajem, srbečico in koprivnico
- Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin
- zvišanje alaninaminotransferaze, alkalne fosfataze, laktatdehidrogenaze in protrombina
Signs may include severe pain in the chest, breathlessness, confusion, difficulty with speech or movement (paralysis) or abdominal pain.
Med znaki so lahko huda bolečina v prsih, zadihanost, zmedenost, težave z govorom ali gibanjem (ohromelost) ali bolečine v trebuhu.
In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of Disseminated Intravascular Coagulation (DIC) in association with NovoSeven treatment.
V patoloških stanjih, pri katerih je lahko tkivni faktor izražen znatneje kot normalno, obstaja med zdravljenjem z zdravilom NovoSeven možno tveganje za trombotične dogodke ali indukcije diseminirane intravaskularne koagulacije (DIK).
Solvent for NovoSeven
Topilo za NovoSeven
• Blood clots in arteries in the heart (which could lead to a heart attack or angina), in the brain (which could lead to a stroke) or in the intestine and kidneys.
• Krvni strdki v srčnih arterijah (posledica je lahko srčni infarkt ali angina pektoris), možganskih arterijah (posledica je lahko možganska kap), črevesnih ali ledvičnih arterijah.
A major bleeding episode may be treated for 2 - 3 weeks but can be extended beyond this if clinically warranted.
Večjo krvavitev se lahko zdravi od 2 do 3 tedne ali še dalj, če je klinično upravičeno.
These devices are not included in the NovoSeven package.
Ti pripomočki niso vključeni v pakiranje zdravila NovoSeven.
The reconstituted NovoSeven must be injected into your vein (intravenous injection).
Pripravljeno zdravilo NovoSeven je treba injicirati v veno (intravenska injekcija).
• Ensure that a vial adapter is used irrespective of presentation.
• Poskrbeti morate, da je nastavek za vialo uporabljen ne glede na farmacevtsko obliko zdravila.
Mean volume of distribution at steady state was 196 ml/kg in paediatric patients versus 159 ml/kg in adults.
Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja je bil pri pediatričnih bolnikih 196 ml/kg in pri odraslih 159 ml/kg.
• If your arteries are narrowed by disease (atherosclerosis)
• če imate zaradi bolezni zožene arterije (ateroskleroza),
The most frequently reported adverse drug reactions are decreased therapeutic response, pyrexia, rash, venous thromboembolic events, pruritus and urticaria.
Najpogosteje opisani neželeni učinki so zmanjšan terapevtski odziv, pireksija, izpuščaj, venski trombembolični dogodki, srbenje in urtikarija.
Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as the oral cavity.
Opisano je, da antifibrinolitiki pri bolnikih s hemofilijo zmanjšajo izgubo krvi med operacijami, zlasti pri ortopedskih operacijah in operacijah v predelih z izrazito fibrinolitično aktivnostjo, kot je npr. ustna votlina.
The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
Priporočeni začetni odmerek, apliciran z intravensko bolusno injekcijo, je 90 µg na kg telesne mase.
• Grasp the plunger rod by the wide top-end and take it out of the carton.
• Primite nosilec bata za široki zgornji del in ga vzemite iz škatle.
• 1 plunger rod (placed under the syringe)
• 1 nosilec bata (nameščen pod brizgo).
• 1 vial with NovoSeven powder
• 1 vialo s praškom NovoSeven,
Explain that you have been using NovoSeven.
Povejte, da ste uporabljali zdravilo NovoSeven.
What NovoSeven looks like and contents of the pack
Izgled zdravila NovoSeven in vsebina pakiranja
There is limited experience of using NovoSeven together with medicines called antifibrinolytic drugs (such as aminocaproic acid or tranexamic acid) which are also used to control bleeding.
O sočasni uporabi zdravila NovoSeven in antifibrinolitičnih zdravil (npr. aminokaprojska ali traneksamska kislina), ki se prav tako uporabljajo za obvladovanje krvavitev, je izkušenj malo.
NovoSeven is supplied as a powder.
Zdravilo NovoSeven je na voljo kot prašek.
Factor VII deficient patients should be monitored for prothrombin time and factor VII coagulant activity before and after administration of NovoSeven.
Pri bolnikih s pomanjkanjem faktorja VII je treba pred in po uporabi zdravila NovoSeven nadzirati protrombinski čas in koagulacijsko aktivnost faktorja VII.
• Draw approximately 5 ml of sterile air into the 50 ml syringe (polypropylene).
• V 50-mililitrsko brizgo (polipropilen) potegnite približno 5 ml sterilnega zraka.
If devices other than those supplied by Novo Nordisk are used, ensure the use of an adequate filter with a pore size of 25 micrometer.
Če za pripravo zdravila uporabljate medicinske pripomočke, ki niso priloženi v pakiranju, morate zagotoviti uporabo primernega filtra z velikostjo por 25 mikrometrov.
Make sure not to aim the stream of solvent directly at the NovoSeven powder as this will cause foaming.
Pazite, da ne boste curka topila usmerili neposredno na prašek, ker bi s tem povzročili penjenje.
What NovoSeven is and what it is used for What you need to know before you use NovoSeven How to use NovoSeven
Kaj je zdravilo NovoSeven in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo NovoSeven Kako uporabljati zdravilo NovoSeven Možni neželeni učinki
Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/kg rFVIIa).
Pri otrocih so ob uporabi raziskovanih odmerkov 90 in 180 µg na kilogram telesne mase ugotovili sorazmernost odmerku, kar se ujema s prejšnjimi izsledki pri manjših odmerkih (17,5-70 µg/kg rFVIIa).
• Blood clots in the veins in lungs, legs, liver, kidneys or at site of injection.
• Krvni strdki v venah pljuč, nog, jeter, ledvic ali na mestu injiciranja.
• If you have severe liver disease
• če imate hudo bolezen jeter,
Disposal • After injection, safely dispose of the syringe with the administration set, the vial with the vial adapter, any unused NovoSeven and other waste materials as instructed by your doctor or nurse.
• Po injiciranju varno zavrzite injekcijsko brizgo in komplet za injiciranje, vialo z nastavkom za vialo, vso neporabljeno zdravilo NovoSeven in drug odpadni material, kot vam je naročil vaš zdravnik ali medicinska sestra.
• Do not use any other way to warm the vial and pre-filled syringe.
• Za gretje viale in napolnjene injekcijske brizge ne uporabljajte nobenega drugega načina.
In patients with factor VII deficiency, where the recommended dose is 15 - 30 µg/kg rFVIIa, one episode of overdose has been associated with a thrombotic event (occipital stroke) in an elderly (> 80 year) male patient treated with 10 - 20 times the recommended dose.
Pri bolnikih s pomanjkanjem faktorja VII, pri katerih je priporočeni odmerek 15-30 µg/kg rFVIIa, je bilo eno preveliko odmerjanje povezano s trombotičnim dogodkom (okcipitalna kap) pri starejšem (> 80 let) moškem, ki je dobil 10- do 20-kraten priporočeni odmerek.
In such cases treatment with antihistamines i.v.
takšnih primerih je treba razmisliti o zdravljenju z intravenskimi antihistaminiki.
Before treatment with NovoSeven, make sure your doctor knows:
Pred začetkom uporabe zdravila NovoSeven morate svojemu zdravniku povedati:
Do not freeze the mixed NovoSeven solution and keep it protected from light.
Pripravljene raztopine NovoSeven ne zamrzujte in jo shranjujte zaščiteno pred svetlobo.
If you forget an injection, or if you want to stop the treatment, get your doctor's advice.
Če pozabite injicirati zdravilo NovoSeven Če pozabite injicirati zdravilo ali če želite prenehati zdravljenje, se posvetujte z zdravnikom.
Dose interval
Odmerni interval
The first dose should be given as early as possible after bleeding has started.
Prvi odmerek morate prejeti čim prej po začetku krvavitve.
Following the initial dose of NovoSeven further injections may be repeated.
Po začetnem odmerku zdravila NovoSeven se lahko uporabijo dodatne injekcije.
• Bring the vial and the pre-filled syringe to room temperature (not above 37°C).
• Vialo in napolnjeno injekcijsko brizgo ogrejte na sobno temperaturo (do 37 °C).
Compatibility with the product was demonstrated for the system consisting of a 50 ml syringe (polypropylene), a 2 m infusion tube (polyethylene) and an inline filter with a 5 micrometer pore size.
Kompatibilnost z zdravilom je dokazana za sisteme, sestavljene iz 50-mililitrske brizge (polipropilen), 2-metrske infuzijske cevke (polietilen) in linijskega filtra s 5-mikrometrsko velikostjo por.
Patients undergoing major surgery may be treated for up to 2 - 3 weeks until healing has occurred.
Bolniki, ki so prestali večjo operacijo, lahko zdravilo dobivajo od 2 do 3 tedne, dokler ni končano celjenje.
The recommended dose range in adults and children for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μg per kg body weight every 4 - 6 hours until haemostasis is achieved.
Priporočeno odmerno območje za zdravljenje in preprečevanje krvavitev pri odraslih in otrocih, ki so prestali operacijo ali invazivni postopek, je od 15 do 30 µg na kg telesne mase na 4 do 6 ur, dokler ni dosežena hemostaza.
Under these conditions, chemical and physical stability has been demonstrated for 24 hours at 25°C when stored in a 50 ml syringe (polypropylene).
V takšnih pogojih sta kemična in fizikalna stabilnost dokazani za 24 ur pri temperaturi 25 °C in shranjevanju v 50-mililitrski brizgi (polipropilen).
NovoSeven contains activated recombinant coagulation factor VII.
Zdravilo NovoSeven vsebuje aktivirani rekombinantni koagulacijski faktor VII.
Before injection (administration) it must be reconstituted with the solvent supplied in the syringe.
Pred injiciranjem (uporabo) se ga mora zmešati s topilom, ki je priloženo v injekcijski brizgi.
• in patients with Glanzmann's thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
• pri bolnikih z Glanzmannovo trombastenijo s trenutno ali preteklo refraktarnostjo proti transfuzijam trombocitov, ali če trombociti niso takoj na voljo.
If you do not use it immediately after mixing, you should store the vial with the syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours.
Če ga ne uporabite takoj, morate vialo s še vedno nameščeno brizgo shraniti v hladilniku pri temperaturi od 2 °C do 8 °C, vendar ne več kot 24 ur.
Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight (3 doses each) and/or placebo.
Dobili so 40, 80 in 160 µg rFVIIa na kilogram telesne mase (3 odmerke vsakega) in/ali placebo.
Use the reconstituted NovoSeven at once to avoid infections.
Pripravljeno zdravilo NovoSeven uporabite takoj, da boste preprečili okužbe.
If a larger dose is needed, repeat the procedure with additional vials, pre-filled syringes and vial adapters.
Če je potreben večji odmerek, ponovite postopek z dodatnimi vialami, napolnjenimi injekcijskimi brizgami in nastavki za vialo.
• in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration
• pri bolnikih s prirojeno hemofilijo, pri katerih je pričakovan visok anamnestičen odziv na uporabo faktorja VIII ali faktorja IX,
Clinical trials conducted in 484 patients (including 4297 treatment episodes) with haemophilia A and B, acquired haemophilia, factor VII deficiency or Glanzmann's thrombasthenia have shown that adverse drug reactions are common (≥ 1/100 to < 1/10).
V kliničnih preskušanjih pri 484 bolnikih (4.297 epizod zdravljenja) s hemofilijo A in B, pridobljeno hemofilijo, pomanjkanjem faktorja VII ali Glanzmannovo trombastenijo so se neželeni učinki pojavljali pogosto (≥ 1/100 do < 1/10).
If you inject too much NovoSeven, get medical advice at once.
Če injicirate večji odmerek zdravila NovoSeven, kot bi smeli Če injicirate preveč zdravila NovoSeven, nemudoma poiščite zdravniški nasvet.
The most frequent adverse drug reactions are pyrexia and rash (uncommon: > 1/1,000 to < 1/100), and the most serious adverse drug reactions are thromboembolic events.
Najpogosteje se pojavljajta neželena učinka pireksija in izpuščaj (občasno: ≥ 1/1.000 do < 1/100), najresnejši neželeni učinki pa so trombembolični dogodki.
Pharmacokinetics of NovoSeven in patients with Glanzmann's thrombasthenia have not been investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients.
Farmakokinetika zdravila NovoSeven pri bolnikih z Glanzmannovo trombastenijo ni raziskana, vendar je mogoče pričakovati, da je podobna farmakokinetiki pri bolnikih s hemofilijo A in B. 5.3 Predklinični podatki o varnosti
The powder for solution for injection contains: 1 mg/vial (corresponding to 50 KIU/vial), 2 mg/vial (corresponding to 100 KIU/vial), 5 mg/vial (corresponding to 250 KIU/vial) or 8 mg/vial (corresponding to 400 KIU/vial).
Prašek za raztopino za injiciranje vsebuje: 1 mg/vialo (ustreza 50 k.i.e./vialo), 2 mg/vialo (ustreza 100 k.i.e./vialo), 5 mg/vialo (ustreza 250 k.i.e./vialo) ali 8 mg/vialo (ustreza 400 k.i.e./vialo).
peripheral ischaemia, peripheral arterial thrombosis and intestinal ischaemia)
periferna ishemija, tromboza periferne arterije in ishemija črevesa)
The recommended dose for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 90 µg (range 80 - 120 µg) per kg body weight at intervals of two hours (1.5 - 2.5 hours).
Priporočeni odmerek za zdravljenje krvavitev in za preprečevanje krvavitev pri bolnikih, ki so prestali operacije ali invazivne postopke, je 90 µg (razpon od 80 do 120 µg) na kg telesne mase v dveurnih presledkih (od 1,5 do 2,5 ure).
Pharmacological doses of NovoSeven activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor.
Farmakološki odmerki zdravila NovoSeven aktivirajo faktor X neposredno na površini aktiviranih trombocitov, ki se nahajajo na mestu poškodbe,
Using the FVII clotting assay, the pharmacokinetics of rFVIIa were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study.
Farmakokinetiko rFVIIa so v študiji s povečevanjem odmerka raziskali pri 35 zdravih belskih in japonskih preiskovancih s koagulacijskim preizkusom z FVII.
In an observational registry (F7HAEM-3578) covering subjects with congenital FVII deficiency, the median dose for long term prophylaxis against bleeding in 22 paediatric patients (below 12 years of age) with Factor VII deficiency and a severe clinical phenotype was 30 µg/kg (range 17 µg/kg to 200 µg/kg; the dose most often used was 30 µg/kg in 10 patients) with a median dose frequency of 3 doses per week (range 1 to 7; the dose frequency most often reported was 3 per week in 13 patients).
V opazovalnem registru (F7HAEM-3578), ki zajema osebe s prirojenim pomanjkanjem FVII, je bil mediani odmerek za dolgotrajno profilakso krvavitev pri 22 pediatričnih bolnikih (mlajših od 12 let) s pomanjkanjem faktorja VII in hudim kliničnim fenotipom 30 µg/kg (razpon: 17 µg/kg - 200 µg/kg; najpogosteje uporabljen je bil odmerek 30 µg/kg pri 10 bolnikih).
Each NovoSeven pack contains:
Eno pakiranje zdravila NovoSeven vsebuje:
What you need to know before you use NovoSeven Do not use NovoSeven
Kaj morate vedeti, preden boste uporabili zdravilo NovoSeven Ne uporabljajte zdravila NovoSeven,
If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 - 2 days.
Če je indicirano nadaljnje zdravljenje, je mogoče odmerni interval nato 1 do 2 dneva podaljšati na 3 ure.
- Arterial thromboembolic events (myocardial infarction, cerebral infarction, cerebral ischaemia, cerebral artery occlusion, cerebrovascular accident, renal artery thrombosis,
- arterijski trombembolični dogodki (miokardni infarkt, možganski infarkt, možganska ishemija, zapora možganske arterije,
• An in-line filter with a 5 micrometer pore size must be ensured for administration.
• Za dajanje zdravila je treba zagotoviti, da je uporabljen linijski filter s 5-mikrometrsko velikostjo por.
It is recommended to use NovoSeven immediately after reconstitution, unless as described in section
Priporočljivo je, da zdravilo NovoSeven uporabite takoj po pripravi, razen v primeru, opisanem v poglavju 6.3.
An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated.
Priporočen je začetni odmerek 90 µg na kg telesne mase; aplicirati ga je mogoče na poti v bolnišnico,
• If you are prone to disseminated intravascular coagulation (DIC, a condition where blood clots develop throughout the blood stream) you must be carefully monitored.
• če ste nagnjeni k diseminirani intravaskularni koagulaciji (DIK, stanje, pri katerem povsod v krvnem obtoku nastajajo krvni strdki).
Single dose pharmacokinetics of rFVIIa, 15 and 30 μg per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: Volume of distribution at steady state (280 - 290 ml/kg), half-life (2.82 - 3.11 h), total body clearance (70.8 - 79.1 ml/h×kg) and mean residence time (3.75 - 3.80 h).
Farmakokinetika posamičnih odmerkov rFVIIa 15 in 30 µg na kg telesne mase se med odmerkoma ni značilno razlikovala po parametrih, neodvisnih od odmerka: volumnu porazdelitve v stanju dinamičnega ravnovesja (280-290 ml/kg), razpolovnem času (2,82-3,11 ure), skupnem telesnem očistku (70,8-79,1 ml/h×kg) in povprečnem času zadrževanja (3,75-3,80 ure).