natgillin/translations-raw huggingface dataset:
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 pojedinačne doze rFVIIa, 15 i 30 µg po kg tjelesne težine, iskazana u parametrima neovisnim o dozi nije pokazala značajnu razliku između dviju doza: volumen distribucije u stanju dinamičke ravnoteže (280 - 290 ml/kg), poluvijek (2,82 -3,11 h), ukupni klirens (70,8 - 79,1 ml/h×kg) i srednje vrijeme zadržavanja (3,75 - 3,80 h).
• Changes in some liver and blood tests.
• Glavobolja • Promijenjeni rezultati nekih pretraga jetre i krvi.
Thromboembolic events - arterial and venous
Tromboembolije - arterijske i venske
Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC.
Do takvih situacija može doći u bolesnika s uznapredovalom aterosklerotskom bolesti, ozljedama tipa nagnječenja, sepsom ili DIK-om.
Plastic cap Rubber stopper
Plastični zatvarač Gumeni čep
Please refer to outer packaging for present pack size.
Molimo pogledajte vanjsko pakiranje kako biste utvrdili o kojoj se veličini pakiranja radi.
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.
Postoje izvješća da antifibrinolitici smanjuju gubitak krvi tijekom operativnih zahvata u bolesnika s hemofilijom, osobito u ortopedskim zahvatima i operativnim zahvatima onih regija koje su bogate fibrinolitičkom aktivnošću, poput usne šupljine.
Thrombin leads to the activation of platelets and factors V and VIII at the site of injury and to the formation of the haemostatic plug by converting fibrinogen into fibrin.
Trombin aktivira trombocite i faktor V i VIII na mjestu ozljede i stvara hemostatski ugrušak pretvorbom fibrinogena u fibrin.
If not used immediately, the conditions prior to use are the responsibility of the user and the in-use storage time must not be longer than as stated above.
Ako se ne primijeni odmah, uvjeti čuvanja prije primjene lijeka odgovornost su korisnika i lijek se ne smije čuvati dulje od gore navedenog.
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.
Ako ga ne primijenite odmah nakon miješanja, bočicu s pričvršćenom štrcaljkom trebate čuvati u hladnjaku od 2°C do 8°C, ne dulje od 24 sata.
The most frequently reported adverse drug reactions are decreased therapeutic response, pyrexia, rash, venous thromboembolic events, pruritus and urticaria.
Najčešće prijavljivane nuspojave su smanjen terapijski odgovor, pireksija, osip, venska tromboembolija, pruritus i urtikarija.
The dose interval may then be increased to 6 - 8 hours for another 2 weeks of treatment.
Interval doziranja potom se može produljiti na 6 - 8 sati tijekom sljedeća 2 tjedna liječenja.
The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion.
Preporučeni je način primjene lijeka u bolus injekciji, jer se uz kontinuiranu infuziju može pojaviti nedostatak djelotvornosti.
No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann's thrombasthenia.
Nisu prijavljeni slučajevi predoziranja u bolesnika sa stečenom hemofilijom ili Glanzmannovom trombastenijom.
Injecting NovoSeven with pre-filled syringe via needleless connectors for intravenous (IV) catheters
Injiciranje lijeka NovoSeven s napunjenom štrcaljkom putem konektora za primjenu bez igle za intravenske (i.v.) katetere
- Pyrexia
- Pireksija
• in patients with Glanzmann's thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
• u bolesnika s Glanzmannovom trombastenijom s prethodnom ili trenutnom refraktornošću na transfuzije trombocita ili kad trombociti nisu odmah dostupni
Signs may include difficulty in breathing, red and painful swelling in the leg and abdominal pain.
Znakovi mogu biti poteškoće s disanjem, crvena i bolna oteklina u nozi i bol u trbuhu.
Following the initial dose of NovoSeven further injections may be repeated.
Nakon početne doze lijeka NovoSeven, mogu se ponovno dati dodatne injekcije.
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.
U patološkim stanjima pri kojima izražavanje tkivnog faktora može biti veće od normalnog možda postoji potencijalni rizik za razvoj tromboze ili nastanak diseminirane intravaskularne koagulacije
It is recommended to use NovoSeven immediately after reconstitution, unless as described in section
Preporučuje se NovoSeven primijeniti odmah nakon rekonstitucije, osim kako je opisano u dijelu 6.3.
Dose and dose interval
Doza i interval doziranja
• NovoSeven is now ready for injection.
• NovoSeven je sada spreman za injiciranje.
• An in-line filter with a 5 micrometer pore size must be ensured for administration.
• Za primjenu se mora osigurati in-line filter, veličine pora od 5 mikrometara.
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.
Preporučeni je raspon doze u odraslih i djece u liječenju epizoda krvarenja te u prevenciji krvarenja u bolesnika koji se podvrgavaju operativnom zahvatu ili invazivnim postupcima 15 - 30 µg po kg tjelesne težine svakih 4 - 6 sati sve dok se ne uspostavi hemostaza.
If you cannot use it immediately, after it has been mixed, you should store it in the vial with the vial adapter and syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours.
Ako ga ne možete primijeniti odmah nakon miješanja trebate ga čuvati u bočici, na kojoj je još uvijek pričvršćen nastavak za bočicu i štrcaljka, u hladnjaku na temperaturi od 2°C do 8°C ne dulje od 24 sata.
Signs may include skin rashes, itching, flushing and hives; wheezing or difficulty breathing; feeling faint or dizzy; and severe swelling of the lips or throat, or at the injection site.
Znakovi mogu biti: kožni osip, svrbež, crvenilo i koprivnjača, piskanje pri disanju ili poteškoće s disanjem, osjećaj nesvjestice ili omaglice, jako oticanje usana ili grla ili mjesta injiciranja.
There are no studies on the effect of NovoSeven on the ability to drive and use machines.
Nema ispitivanja o utjecaju lijeka NovoSeven na sposobnost upravljanja vozilima i strojevima.
Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies (see section 4.4).
U bolesnika s nedostatkom faktora VII koji su liječeni lijekom NovoSeven, treba pratiti razvoj protutijela na faktor VII (vidjeti dio 4.4).
• 1 vial with white powder for solution for injection
• 1 bočicu s bijelim praškom za otopinu za injekciju
MedDRA system organ class
Organski sustav po MedDRA-i
• Use NovoSeven at once after mixing the powder with the solvent to avoid infection.
• Primijenite NovoSeven odmah nakon miješanja praška i otapala kako ne bi došlo do infekcije.
• in patients with congenital haemophilia with inhibitors to coagulation factors VIII or
• u bolesnika s prirođenom hemofilijom s inhibitorima na koagulacijske faktore VIII ili
Ensure that the syringe, the infusion tube and the in-line filter are primed and free of air before administration.
Prije primjene osigurajte da su štrcaljka, infuzijska cjevčica i in-line filter odgovarajuće pripremljeni te da u njima nema zraka.
If you have Factor VII deficiency: The usual dose range is 15 to 30 micrograms for every 1 kilogram you weigh, for each injection.
Ako imate nedostatak faktora VII: Uobičajeni je raspon doze 15 do 30 mikrograma po 1 kilogramu tjelesne težine, za svaku injekciju.
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).
Preporučena je doza u liječenju epizoda krvarenja i u prevenciji krvarenja u bolesnika koji se podvrgavaju operativnom zahvatu ili invazivnim postupcima 90 µg (raspon 80 - 120 µg) po kg tjelesne težine u intervalu od dva sata (1,5 - 2,5 sata).
• Allergic skin reactions including rash, itching and hives
• Alergijske kožne reakcije, uključujući osip, svrbež i koprivnjaču.
The shelf life for the product packed for sale is 3 years when the product is stored below 25°C.
Rok valjanosti lijeka u originalnom pakiranju je 3 godine kad se čuva na temperaturi ispod 25°C.
Procedure for pooling of vials for hospital use only:
Postupak objedinjavanja bočica, samo za bolničku primjenu:
- Store powder and solvent protected from light.
- Prašak i otapalo čuvati zaštićene od svjetlosti.
The efficacy rates were 81% and 82%, respectively, in patients with positive or negative refractoriness to platelet transfusions, and 77% and 85%, respectively, in patients testing positive or negative for antibodies to platelets.
Stope djelotvornosti su bile 81% u bolesnika s pozitivnom refraktornošću na trombocite odnosno 82% u bolesnika s negativnom refraktornošću na trombocite, i 77% u bolesnika s pozitivnim testom na protutijela na trombocite odnosno 85% u bolesnika s negativnim testom na protutijela na trombocite.
A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and death) at a lower dose level than when administering the individual compounds.
Mogući sinergijski učinak kombiniranog liječenja s rFXIII i rFVIIa u uznapredovanom kardiovaskularnom modelu u makaki majmuna rezultirao je pretjeranom farmakološkom reakcijom
NovoSeven is supplied as a powder.
NovoSeven dolazi u obliku praška.
The usual dose is 90 micrograms (range is 80 to 120 micrograms) for every 1 kilogram you weigh, for each injection.
Uobičajena je doza 90 mikrograma (raspon je 80 do 120 mikrograma) po 1 kilogramu tjelesne težine, za svaku injekciju.
• Grasp the plunger rod by the wide top-end and take it out of the carton.
• Uhvatite potisni klip za široki gornji dio i izvadite ga iz kutije.
Administration through a needleless connector may require withdrawal of the reconstituted solution into a standard 10 ml sterile luer-lock plastic syringe.
Ako se lijek primjenjuje kroz konektor za primjenu bez igle možda će biti potrebno pripremljenu otopinu uvući u standardnu sterilnu luer-lock plastičnu štrcaljku od 10 ml.
Data on a limited number of exposed pregnancies within approved indications indicate no adverse effects of rFVIIa on pregnancy or on the health of the foetus/new-born child. To date, no other relevant epidemiological data are available.
Podaci na temelju ograničenog broja slučajeva primjene lijeka u trudnoći u okviru odobrenih indikacija, ukazuju da nema štetnih učinaka rFVIIa na trudnoću ili na zdravlje fetusa/novorođenčeta.
Use the reconstituted NovoSeven at once to avoid infections.
Pripremljeni NovoSeven odmah primijenite kako ne bi došlo do infekcije.
Early treatment with NovoSeven reduces how much you bleed and for how long.
Rano započinjanje terapije s lijekom NovoSeven smanjuje obim i trajanje krvarenja.
Under these conditions, chemical and physical stability has been demonstrated for 24 hours at 25°C when stored in a 50 ml syringe (polypropylene).
Pod tim uvjetima, dokazana kemijska i fizikalna stabilnost iznosi 24 sata na temperaturi od 25°C kada se čuva u štrcaljki od 50 ml (polipropilen).
Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited.
Ograničena su iskustva s istovremenom primjenom antifibrinolitika i rFVIIa.
Instructions on how to use NovoSeven READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOSEVEN
Upute za uporabu lijeka NovoSeven PRIJE PRIMJENE LIJEKA NOVOSEVEN PAŽLJIVO PROČITAJTE OVE UPUTE
Your doctor may recommend a single dose of 270 micrograms for every 1 kilogram you weigh.
Liječnik Vam može preporučiti pojedinačnu dozu od 270 mikrograma po 1 kilogramu tjelesne težine.
The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or the surgery being performed.
Trajanje liječenja i interval između injekcija varirat će ovisno o težini krvarenja, invazivnom postupku ili operativnom zahvatu koji se provodi.
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, histidine, water for injections
natrijev klorid, kalcijev klorid dihidrat, glicilglicin, polisorbat 80, manitol, saharoza, metionin, histidin, voda za injekcije
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 praznu štrcaljku s nastavka za bočicu te za obje vrste spremnika osigurajte da je nastavak za bočicu pričvršćen na bočicu koja sadrži rekonstituirani lijek.
Safely dispose of the syringe, vials, any unused product and other waste materials as instructed by your healthcare professional.
Oprezno bacite u otpad štrcaljku, bočice, neiskorišteni lijek i drugi otpadni materijal u skladu s uputama zdravstvenog radnika.
The reconstituted solution is colourless.
Pripremljena otopina je bezbojna.
In addition, the development of antibodies against NovoSeven and FVII has been associated with overdose in one patient with factor VII deficiency.
NovoSeven i FVII bio je povezan s predoziranjem u jednog bolesnika s nedostatkom faktora VII.
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.
• Nakon injiciranja, oprezno bacite u otpad štrcaljku sa setom za primjenu, bočicu s nastavkom za bočicu, neiskorišteni NovoSeven i drugi otpadni materijal u skladu s uputama koje ste dobili od liječnika ili medicinske sestre.
NovoSeven is now ready for injection.
NovoSeven je sada spreman za injiciranje.
• Repeat the procedure with the appropriate number of additional vials, solvent vials/pre-filled syringes and vial adapters.
• Ponovite postupak s odgovarajućim brojem dodatnih bočica, otapala u bočicama/napunjenim štrcaljkama i nastavaka za bočice.
These devices are not included in the NovoSeven package.
Ovaj pribor nije uključen u pakiranje lijeka NovoSeven.
Calcium chloride dihydrate Glycylglycine
Natrijev klorid Kalcijev klorid dihidrat Glicilglicin
The reconstituted solution should be stored in the vial.
Rekonstituiranu otopinu treba čuvati u bočici.
Table 1 lists adverse reactions reported during clinical trials and from spontaneous (post-marketing) reports.
Tablični prikaz nuspojava Tablica 1 prikazuje nuspojave prijavljene tijekom kliničkih ispitivanja i spontano (nakon stavljanja lijeka u promet) prijavljene nuspojave.
Inhibitory antibody formation
Stvaranje inhibitornih protutijela
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton text
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Tekst na vanjskoj kutiji
How to store NovoSeven
Kako čuvati NovoSeven
Each pack contains: 1 vial of powder 1 vial of solvent
Svako pakiranje sadrži: 1 bočicu s praškom 1 bočicu s otapalom
The dose will be worked out by your doctor, based on your body weight, condition and type of bleed.
Vaše tjelesne težine, stanja i vrste krvarenja.
Using the FVII clotting assay, the pharmacokinetics of rFVIIa were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study.
Distribucija, eliminacija i linearnost Farmakokinetika rFVIIa ispitana je praćenjem aktivnosti FVII u 35 zdravih bijelaca i Japanaca u ispitivanju s povećanjem doze.
If continued therapy is needed, the dose interval can be increased successively once effective haemostasis is achieved to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated.
Ukoliko je potrebna kontinuirana terapija, interval doziranja može se postupno povećati kad se postigne učinkovita hemostaza na svakih 4, 6, 8 ili 12 sati sve dok je procijenjeno da je liječenje potrebno.
Vial: Type I glass vial closed with a chlorobutyl rubber stopper, covered with an aluminium cap.
I zatvorena klorbutilnim gumenim čepom koji je pokriven aluminijskim zatvaračem.
Lightly squeeze the protective cap with the thumb and index finger.
Lagano pritisnite zaštitni omot palcem i kažiprstom.
The reconstituted solution has a pH of approximately 6.0.
Otapalo: bistra, bezbojna otopina. pH rekonstituirane otopine je otprilike 6,0.
How to use NovoSeven
Kako primjenjivati NovoSeven
The solvent of NovoSeven is provided in either a vial or in a pre-filled syringe.
Otapalo lijeka NovoSeven nalazi se ili u bočici ili u napunjenoj štrcaljki.
If a larger dose is needed, repeat the procedure with additional vials, pre-filled syringes and vial adapters.
Ako trebate veću dozu ponovite postupak s dodatnim bočicama, napunjenim štrcaljkama i nastavcima za bočicu.
• Store powder and solvent below 25°C.
• Prašak i otapalo čuvati na temperaturi ispod 25°C.
- Related laboratory findings, including elevated levels of Ddimmer and decreased levels of AT (see section
- Povezani laboratorijski nalazi uključujući povećanu razinu D-dimera i sniženu razinu antitrombina
Pharmacological doses of NovoSeven activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor.
Farmakološke doze lijeka NovoSeven aktiviraju faktor X izravno na površini aktiviranih trombocita,
Do not store the solution without your doctor's advice.
Ne čuvajte otopinu bez savjeta liječnika.
Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to dry for a few seconds before use.
Obrišite gumeni čep na bočici sterilnim alkoholnim tupferom i pričekajte nekoliko sekundi da se osuši prije uporabe.
The frequencies of both serious and non-serious adverse drug reactions are listed by system organ classes in the table below
Učestalosti ozbiljnih nuspojava i nuspojava koje nisu ozbiljne navedene su prema organskim sustavima u tablici u nastavku.
Table 1 Adverse reactions from clinical trials and spontaneous (post-marketing) reports
Tablica 1 Nuspojave prijavljene u kliničkim ispitivanjima i spontano (nakon stavljanja lijeka u promet) prijavljene nuspojave
• Store powder and solvent protected from light.
• Prašak i otapalo čuvati zaštićene od svjetlosti.
The ingredients in the solvent are histidine, hydrochloric acid, sodium hydroxide, water for injections.
Sastojci u otapalu su histidin, kloridna kiselina, natrijev hidroksid, voda za injekcije.
The NovoSeven powder must be reconstituted with its solvent and injected into a vein.
NovoSeven prašak mora biti pripremljen s pripadajućim otapalom i injiciran u venu.
Pooling of vials (hospital use only):
Objedinjavanje bočica (samo za bolničku primjenu):
- Flushing - Angioedema
- Navale crvenila - Angioedem
Signs may include severe pain in the chest, breathlessness, confusion, difficulty with speech or movement (paralysis) or abdominal pain.
Znakovi mogu biti jaka bol u prsnom košu, nedostatak zraka, smetenost, poteškoće s govorom ili pokretima
Plunger rod: made of polypropylene.
Potisni klip napravljen je od polipropilena.
After reconstitution, 1 ml of the solution contains 1 mg eptacog alfa (activated).
Nakon pripreme za primjenu, 1 ml otopine sadrži 1 mg eptakoga alfa (aktiviranog).
Dose interval
Interval doziranja
During in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 25°C in a 50 ml syringe (polypropylene).
Tijekom in vitro ispitivanja, dokazana je kemijska i fizikalna stabilnost pripremljene otopine tijekom 24 sata kada se čuva na temperaturi od 25°C u štrcaljki od 50 ml (polipropilen).
The risk of a potential interaction between NovoSeven and coagulation factor concentrates is unknown.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Rizik moguće interakcije između lijeka NovoSeven i koncentrata koagulacijskih faktora nije poznat.
- Injection site reaction including injection site pain
uključujući bol na mjestu injiciranja
Mild to moderate bleeding episodes (including home therapy) Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds.
Rana intervencija pokazala se učinkovitom u liječenju blagih do umjereno teških zglobnih, mišićnih i mukokutanih krvarenja.
Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated.
Nakon toga interval doziranja može se postupno povećati na svakih 4, 6, 8 ili 12 sati sve dok je procijenjeno da je liječenje potrebno.
Severity of bleeding condition and clinical response to NovoSeven administration must guide dosing requirements.
Doziranje se određuje na temelju težine stanja krvarenja i kliničkog odgovora na primjenu lijeka NovoSeven.
Rare (≥1/10,000 to <1/1,000) Frequency Not Known
Manje često (≥1/1000 do <1/100)
Push the plunger rod gently to inject a little air into the vial.
Nježno pritišćite potisni klip kako bi ubrizgali malo zraka u bočicu.
Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (212 years) and 5 adult patients in non-bleeding state.
Farmakokinetička svojstva rFVIIa ispitana su u 12 pedijatrijskih bolesnika (2 - 12 godina) i u 5
In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven or FVII in patients with haemophilia A or B. Development of inhibitory antibodies to NovoSeven has been reported in a post-marketing observational registry of patients with congenital FVII deficiency.
U iskustvima nakon stavljanja lijeka na tržište, nije bilo prijavljenih slučajeva stvaranja inhibitornih protutijela na NovoSeven ili FVII u bolesnika s hemofilijom A ili B.
Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.
Držite štrcaljku s bočicom okrenutom naopako i povucite klip kako biste uvukli svu otopinu u štrcaljku.
Rare (may affect up to 1 in 1,000 treatment episodes)
Rijetke (mogu se javiti u do 1 na 1000 liječenih slučajeva)
- Intracardiac thrombus including portal vein thrombosis, renal vein thrombosis, thrombophlebitis, superficial thrombophlebitis and intestinal ischaemia)
plućna embolija, tromboembolija jetre uključujući trombozu portalne vene, tromboza renalne vene, tromboflebitis, površinski tromboflebitis i intestinalna ishemija)
Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe).
Prije okretanja štrcaljke naopako, provjerite da li je klip potpuno potisnut (može se dogoditi da ga tlak u štrcaljki pogura prema van).
• Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml equals cc on the syringe).
• Povucite klip kako biste uvukli volumen zraka jednak volumenu otapala u bočici s otapalom (ml odgovaraju oznaci cc na štrcaljki).
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection eptacog alfa (activated)
NovoSeven 1 mg (50 KIU) prašak i otapalo za otopinu za injekciju NovoSeven 2 mg (100 KIU) prašak i otapalo za otopinu za injekciju NovoSeven 5 mg (250 KIU) prašak i otapalo za otopinu za injekciju NovoSeven 8 mg (400 KIU) prašak i otapalo za otopinu za injekciju eptakog alfa (aktivirani)
This should be done right after step J.
To se treba napraviti odmah nakon koraka J. 5. Injicirajte pripremljenu otopinu