natgillin/translations-raw huggingface dataset:
Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged to be indicated.
Kada se postigne hemostaza, interval doziranja može se postupno povećati na svakih 4, 6, 8 ili 12 sati sve dok je procijenjeno da je liječenje potrebno.
Usually severe bleeds are treated at the hospital and you can give yourself the first NovoSeven dose on the way there.
a na putu do tamo možete si sami dati prvu dozu lijeka NovoSeven.
The solvent is a histidine solution.
Otapalo je histidinska otopina.
The NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter and discolouration prior to administration.
Rekonstituirana otopina lijeka NovoSeven bezbojna je i treba je prije primjene vizualno pregledati na prisutnost čestica ili promjenu boje.
Powder in vial and solvent in pre-filled syringe:
Prašak u bočici i otapalo u napunjenoj štrcaljki:
Dose, dose range and dose interval
Doza, raspon doze i interval doziranja
Thrombosis has been reported in FVII deficient patients receiving NovoSeven during surgery but the risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown (see section 5.1).
ali je rizik pojave tromboze u bolesnika s nedostatkom faktora VII liječenih lijekom NovoSeven nepoznat (vidjeti dio 5.1).
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.
24 sata na temperaturi od 2°C - 8°C, osim ako rekonstitucija nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
The powder vial contains white powder and the pre-filled syringe contains a clear colourless solution.
Bočica s praškom sadrži bijeli prašak, a napunjena štrcaljka sadrži bistru, bezbojnu otopinu.
1 vial of powder
1 bočicu s praškom
- Nausea
- Mučnina
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).
Prašak za otopinu za injekciju sadrži: 1 mg/bočici (što odgovara 50 KIU/bočici), 2 mg/bočici (što odgovara 100 KIU/bočici), 5 mg/bočici (što odgovara 250 KIU/bočici) ili 8 mg/bočici (što odgovara 400 KIU/bočici).
Rubber stopper (under plastic cap)
(ispod plastičnog zatvarača)
The NovoSeven 5 mg (250 KIU)/NovoSeven 8 mg (400 KIU) package contains either - 1 vial (12 ml) with white powder for solution for injection - 1 vial (12 ml) with solvent for reconstitution or
Pakiranje lijeka NovoSeven 5 mg (250 KIU)/NovoSeven 8 mg (400 KIU) sadrži ili - 1 bočicu (12 ml) s bijelim praškom za otopinu za injekciju - 1 bočicu (12 ml) s otapalom za rekonstituciju ili
Overleaf: Instructions on how to use NovoSeven
Na poleđini: upute za uporabu lijeka NovoSeven.
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
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
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.
53 ml/h×kg), dok je srednji terminalni poluvijek bio 2,3 sata u obje skupine.
- Headache
- Glavobolja
• Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
• Prestanite pritiskati potisni klip i pustite ga da se samostalno pomiče unatrag dok pripremljena otopina ne ispuni štrcaljku.
Safely dispose of the syringe, vials and any unused product.
Zbrinite štrcaljku, bočice i neiskorišteni lijek na siguran način.
Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
Uklonite zatvarač štrcaljke s napunjene štrcaljke savijajući ga prema dolje dok se perforirani dio ne odvoji.
• The NovoSeven powder vial and pre-filled syringe with solvent should be at room temperature at reconstitution.
• Bočica s NovoSeven praškom i napunjena štrcaljka s otapalom prilikom rekonstitucije trebaju biti na sobnoj temperaturi.
The mean steady state volume of distribution ranged from 130 to 165 ml/kg, the mean values of clearance ranged from 33.3 to 37.2 ml/h×kg.
dok su se srednje vrijednosti klirensa kretale u rasponu od 33,3 do 37,2 ml/h×kg.
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).
B Povucite klip kako biste uvukli volumen zraka jednak volumenu otapala u bočici s otapalom (ml odgovaraju oznaci cc na štrcaljki).
Do not store the reconstituted solution without advice from your doctor or nurse.
Nemojte čuvati pripremljenu otopinu bez savjetovanja sa svojim liječnikom ili medicinskom sestrom.
NovoSeven is now ready to inject into your vein.
NovoSeven je sada spreman za injiciranje u venu.
Investigations
Pregled
Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Odmah spojite potisni klip sa štrcaljkom tako da ga navijate u smjeru kazaljke na satu, u klip koji se nalazi u napunjenoj štrcaljki, sve dok ne osjetite otpor.
• Ensure that a vial adapter is used irrespective of presentation.
• Osigurajte korištenje nastavka za bočicu neovisno o vrsti spremnika.
Do not store the solution without advice from your doctor or nurse.
Ne čuvajte otopinu bez savjeta liječnika ili medicinske sestre.
• in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration
IX > 5 Bethesda jedinica (BU) • u bolesnika s prirođenom hemofilijom u kojih se očekuje jaki anamnestički odgovor na primjenu faktora VIII ili faktora IX
- Arterial thromboembolic events (myocardial infarction, cerebral infarction, cerebral ischaemia, cerebral artery occlusion, cerebrovascular accident, renal artery thrombosis,
cerebralni infarkt, cerebralna ishemija, okluzija cerebralne arterije, cerebrovaskularni inzult, tromboza renalne arterije, periferna ishemija, periferna arterijska tromboza i intestinalna ishemija)
• 1 plunger rod (placed under the syringe)
• 1 napunjenu štrcaljku s otapalom • 1 potisni klip (smješten ispod štrcaljke)
Vial with NovoSeven powder
Bočica s NovoSeven praškom
1 pre-filled syringe of solvent with separate plunger rod 1 vial adapter for reconstitution
1 napunjenu štrcaljku s otapalom i zasebnim potisnim klipom 1 nastavak za bočicu za pripremu otopine za primjenu
The NovoSeven 1 mg (50 KIU)/NovoSeven 2 mg (100 KIU) package contains either - 1 vial (2 ml) with white powder for solution for injection - 1 vial (2 ml) with solvent for reconstitution or
Pakiranje lijeka NovoSeven 1 mg (50 KIU)/NovoSeven 2 mg (100 KIU) sadrži ili - 1 bočicu (2 ml) s bijelim praškom za otopinu za injekciju - 1 bočicu (2 ml) s otapalom za rekonstituciju ili
Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment episodes, showed that certain adverse drug reactions were reported more frequently (1% based on treatment episodes): Arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), venous thromboembolic events (pulmonary embolism and deep vein thrombosis), angina pectoris, nausea, pyrexia, erythematous rash and investigation of increased levels of fibrin degradation products.
arterijska tromboembolija (okluzija cerebralne arterije, cerebrovaskularni incident), venska tromboembolija (pulmonarna embolija i duboka venska tromboza), angina pektoris, mučnina, pireksija, eritematozni osip i pretrage vezane uz povećanu razinu produkata nastalih razgradnjom fibrina.
• 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).
Primjena • Prije okretanja štrcaljke naopako, provjerite da li je klip potisnut do kraja (može se dogoditi da ga tlak u štrcaljki pogura prema van).
• Remove the empty solvent vial.
• Uklonite praznu bočicu s otapalom.
- Venous thromboembolic events (deep vein thrombosis, thrombosis at i.v.
- Venski tromboembolijski događaji (duboka venska tromboza,
• The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide.
• Drugi sastojci u prašku su natrijev klorid, kalcijev klorid dihidrat, glicilglicin, polisorbat 80,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for pre-filled syringe with solvent
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica za napunjenu štrcaljku s otapalom
Store below 25°C Do not freeze
Čuvati na temperaturi ispod 25°C.
If you use a vial adapter, tip the syringe to remove it from the vial.
Ako koristite nastavak za bočicu, nagnite štrcaljku kako biste je odstranili s bočice.
You should talk to your doctor before using NovoSeven if you also use Factor VIII or IX products.
Ako primjenjujete lijekove s faktorom VIII ili IX, obratite se svom liječniku prije primjene lijeka NovoSeven.
• If you have acquired haemophilia
• ako imate stečenu hemofiliju
Remove the protective paper from the vial adapter without taking it out of the protective cap.
Uklonite zaštitni papir s nastavka za bočicu, ali nemojte nastavak za bočicu izvaditi iz zaštitnog omota.
An initial dose of 90 µg per kg body weight should be given immediately before the intervention.
Neposredno prije zahvata treba primijeniti početnu dozu od 90 µg po kg tjelesne težine.
Patients with acquired haemophilia
Bolesnici sa stečenom hemofilijom
NOVOSEVEN USER INSTRUCTIONS
UPUTE ZA UPORABU LIJEKA NOVOSEVEN
The closed vial is equipped with a polypropylene tamper-evident snap-off cap.
Zatvorena bočica opremljena je polipropilenskim zatvaračem s evidencijom otvaranja koji se lagano odvaja.
After administration of rFVIIa, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of rFVIIa.
(aPTV) skraćuju se, ali nema dokazane korelacije između PV i aPTV te kliničke djelotvornosti rFVIIa.
• in patients with acquired haemophilia
• u bolesnika sa stečenom hemofilijom
Pull the plunger to draw the solvent into the syringe.
Povucite klip kako biste uvukli otapalo u štrcaljku.
• NovoSeven powder and solvent vials should be at room temperature at reconstitution.
• Bočice s NovoSeven praškom i otapalom prilikom rekonstitucije trebaju biti na sobnoj temperaturi.
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).
200 µg/kg; najčešće primjenjivana doza, u 10 bolesnika, bila je 30 µg/kg) s medijanom učestalosti doziranja od 3 doze tjedno (raspon 1 do 7: najčešće prijavljena učestalost bila je 3 doze tjedno u 13 bolesnika).
Powder and solvent for solution for injection Eptacog alfa (activated)
Prašak i otapalo za otopinu za injekciju eptakog alfa (aktivirani)
The syringe cap consists of bromobutyl rubber and polypropylene tamper evident seal.
Zatvarač štrcaljke sastoji se od brombutilne gume i polipropilenskog zatvarača s evidencijom otvaranja.
Uncommon (may affect up to 1 in 100 treatment episodes)
Manje česte (mogu se javiti u do 1 na 100 liječenih slučajeva)
The expiry date is printed after ‘EXP' on the outer carton, on the vial, on the vial adapter and on the pre-filled syringe.
Rok valjanosti otisnut je iza „Rok valjanosti“ na kutiji, bočici, nastavku za bočicu i napunjenoj štrcaljki.
If using a transfer needle, remove the protective cap and insert the transfer needle into the rubber stopper of the solvent vial.
Ako koristite iglu za prijenos, uklonite zaštitni omot i umetnite iglu za prijenos u gumeni čep bočice s otapalom.
Remove the empty solvent vial.
E Uklonite praznu bočicu s otapalom.
• Attach the syringe with the vial adapter or transfer needle to the powder vial.
• Pričvrstite štrcaljku s nastavkom za bočicu ili iglom za prijenos na bočicu s praškom.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove
If using a transfer needle, screw the transfer needle tightly onto the syringe.
Ako koristite iglu za prijenos, čvrsto navijte iglu za prijenos na štrcaljku.
If the protective paper is not fully sealed or it is broken do not use the vial adapter.
Ako zaštitni papir nije u potpunosti pričvršćen ili je oštećen nemojte koristiti nastavak za bočicu.
If you use a transfer needle, remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer needle off the syringe.
Ako koristite iglu za prijenos, izvadite iglu za prijenos iz bočice, stavite natrag zatvarač na iglu za prijenos te odvijte iglu za prijenos sa štrcaljke.
For those patients who are not refractory, platelets is the first line treatment for Glanzmann's thrombasthenia.
Trombociti su prva linija liječenja Glanzmannove trombastenije u onih bolesnika koji nisu refraktorni.
5.2 Pharmacokinetic properties
5.2 Farmakokinetička svojstva Zdravi ispitanici
Push the plunger slowly to inject the solvent into the powder vial.
Polako pritisnite klip kako biste otapalo ubrizgali u bočicu s praškom.
Do not use the reconstituted solution if you notice particles in it or if it is discoloured.
Nemojte primijeniti pripremljenu otopinu ako uočite stvaranje čestica ili promjenu boje.
Attach the syringe with vial adapter or transfer needle to the powder vial.
Pričvrstite štrcaljku s nastavkom za bočicu ili iglom za prijenos na bočicu s praškom.
• Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
• Držite potisni klip pritisnutim do kraja i nježno vrtite bočicu dok se sav prašak ne otopi.
NovoSeven powder and solvent vials should be at room temperature at reconstitution.
Bočice s NovoSeven praškom i otapalom prilikom pripreme za primjenu trebaju biti na sobnoj temperaturi.
If you touch the spike on the vial adapter germs from your fingers can be transferred.
Ako dotaknete šiljak na nastavku za bočicu, može doći do prijenosa mikroorganizama s Vaših prstiju.
- 1 vial (12 ml) with white powder for solution for injection - 1 pre-filled syringe (10 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
- 1 bočicu (12 ml) s bijelim praškom za otopinu za injekciju - 1 napunjenu štrcaljku (10 ml) s otapalom za rekonstituciju - 1 potisni klip
If using a transfer needle, remove transfer needle from the packaging without taking it out of the protective cap. Screw the transfer needle tightly onto the syringe.
Ako koristite iglu za prijenos, izvadite je iz pakiranja, ali je nemojte izvaditi iz zaštitnog omota.
• 1 vial with NovoSeven powder
• 1 bočicu s NovoSeven praškom • 1 nastavak za bočicu
After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent.
Nakon rekonstitucije s otapalom, lijek sadrži 1 mg/ml eptakoga alfa (aktiviranog).
Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution
eptakog alfa (aktivirani) 8 mg/bočici (400 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
If you use a transfer needle, make sure to penetrate the centre of the rubber stopper.
Ako koristite iglu za prijenos, pripazite da probijete sredinu gumenog čepa.
In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to < 1/10)).
FVII jedina je prijavljena nuspojava (učestalost: često (≥ 1/100 i < 1/10)).
In syringe (50 ml polypropylene) in hospital settings only Reconstitution must take place in controlled and validated aseptic conditions by adequately trained staff.
U štrcaljki (50 ml, polipropilen), samo u bolničkom okruženju
Hold the syringe slightly tilted with the vial facing downwards.
Držite štrcaljku lagano nagnutu s bočicom prema dolje.
Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution
eptakog alfa (aktivirani) 5 mg/bočici (250 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
If the caps are loose or missing, do not use the vials.
Ukoliko zatvarači nisu pričvršćeni ili nedostaju, bočice nemojte koristiti.
- 1 vial (2 ml) with white powder for solution for injection - 1 pre-filled syringe (3 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
- 1 bočicu (2 ml) s bijelim praškom za otopinu za injekciju - 1 napunjenu štrcaljku (3 ml) s otapalom za rekonstituciju - 1 potisni klip
Factor VII deficiency
Nedostatak faktora VII Distribucija i eliminacija
Gently swirl the vial until all the powder is dissolved.
• Nježno vrtite bočicu dok se sav prašak ne otopi.
Turn the syringe with the vial upside down and withdraw the contents of the vial into the syringe.
Okrenite štrcaljku s bočicom naopako i izvucite sadržaj bočice u štrcaljku.
• Screw the plunger rod clockwise into the plunger inside the pre-filled syringe until resistance is felt.
• Navijte potisni klip, okrećući ga u smjeru kazaljke na satu, na klip unutar napunjene štrcaljke dok ne osjetite otpor.
Do not take the vial adapter out of the protective cap.
Nastavak za bočicu nemojte vaditi iz zaštitnog omota.
If you are using a transfer needle, make sure that the transfer needle tip is in the solvent.
Ako koristite iglu za prijenos, provjerite da se vršak igle za prijenos nalazi u otopini.
Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution
eptakog alfa (aktivirani) 2 mg/bočici (100 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
• In case you only need part of the reconstituted solution, use the scale on the syringe to see how much of the solution you withdraw, as instructed by your doctor or nurse.
pomoću skale na štrcaljki odredite koliko ćete otopine uvući, u skladu s uputama koje ste dobili od liječnika ili medicinske sestre.
Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution
eptakog alfa (aktivirani) 1 mg/bočici (50 KIU/bočici), 1 mg/ml nakon pripreme otopine za primjenu
Turn over the protective cap, and snap the vial adapter onto the vial.
Okrenite zaštitni omot i pričvrstite nastavak za bočicu na bočicu.
NovoSeven 8 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 8 mg Prašak za injekciju eptakog alfa (aktivirani)
EU/1/96/006/010
EU/1/96/006/006 EU/1/96/006/010
Solvent vial
Hallas Allé
Pull the plunger rod slightly downwards to draw the mixed solution into the syringe.
Lagano povucite potisni klip prema dolje kako biste uvukli izmiješanu otopinu u štrcaljku.
Check the solution for visible particles and discolouration.
Provjerite da u otopini nema vidljivih čestica i da nije promijenila boju.
NovoSeven 5 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 5 mg Prašak za injekciju eptakog alfa (aktivirani)
If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial.
Ako koristite iglu za prijenos, umetnite iglu za prijenos u gumeni čep bočice s otapalom.
• Headache
• Mučnina
Screw the syringe securely onto the vial adapter until resistance is felt.
Čvrsto navijte štrcaljku na nastavak za bočicu dok ne osjetite otpor.
NovoSeven 2 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 2 mg Prašak za injekciju eptakog alfa (aktivirani)
Store below 25°C Do not freeze Store protected from light
POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 25°C.
NovoSeven 1 mg Powder for injection Eptacog alfa (activated) IV
NovoSeven 1 mg Prašak za injekciju eptakog alfa (aktivirani)
EU/1/96/006/008
EU/1/96/006/004 EU/1/96/006/008
If you use a transfer needle, make sure that the transfer needle tip is in the solution.
Ako koristite iglu za prijenos, pazite da se vršak igle za prijenos nalazi u otapalu.
EU/1/96/006/011
EU/1/96/006/007 EU/1/96/006/011
Contents
Doziranje
Hold the prefilled syringe slightly tilted with the vial pointing downwards.
Držite napunjenu štrcaljku lagano nagnutu s bočicom prema dolje.
NovoSeven reconstituted product is a clear, colourless solution.
Pripremljena otopina lijeka NovoSeven bistra je i bezbojna.
EU/1/96/006/005
EU/1/96/006/005 EU/1/96/006/009
• Turn over the protective cap, and snap the vial adapter onto the vial.
• Okrenite zaštiti omot i pričvrstite nastavak za bočicu na bočicu.
NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).
NovoSeven 8 mg (400 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 8 mg eptakoga alfa
NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial).
NovoSeven 2 mg (100 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 2 mg eptakoga alfa
• Hold the syringe with the solvent vial upside down.
• Držite štrcaljku s bočicom s otapalom okrenutom naopako.
• 1 pre-filled syringe with solvent for reconstitution
• 1 bočicu s otapalom za pripremu otopine za primjenu.
If you use a vial adapter, unscrew the vial adapter with the empty vial.
Ako koristite nastavak za bočicu, odvijte nastavak za bočicu s praznom bočicom.
Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger.
I s polipropilenskim graničnikom i brombutilnim gumenim klipom.
NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial).
NovoSeven 1 mg (50 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 1 mg eptakoga alfa
• If using a vial adapter, unscrew the vial adapter with the empty vial.
• Ako koristite nastavak za bočicu, odvijte nastavak za bočicu s praznom bočicom.
The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 2-3 hours until bleeding is controlled.
Ako imate hemofiliju: Uobičajena je doza 90 mikrograma po 1 kilogramu tjelesne težine: injiciranje možete ponoviti svaka
Solvent
Metionin
• Screw the syringe tightly onto the vial adapter on the solvent vial.
• Čvrsto navijte štrcaljku na nastavak za bočicu na bočici s otapalom.
90 µg/kg (range 28 to 450 µg/kg).
Medijan doze po infuziji za liječenje 333 epizoda krvarenja, bio je 90 µg/kg (raspon od 28 do 450 µg/kg).
Plastic cap
KLINIČKI PODACI
NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).
NovoSeven 5 mg (250 KIU) NovoSeven se sastoji od praška i otapala za otopinu za injekciju i sadrži 5 mg eptakoga alfa
Renagel must be taken three times per day with meals.
Renagel se mora uzimati triput na dan uz obrok.
Contact your doctor who will decide on continuing the treatment or not.
Obratite se svome liječniku, koji će odlučiti hoćete li nastaviti s liječenjem ili ne.
Component of a multipack, can't be sold separately.
Sastavnica višestrukog pakiranja, ne može se prodavati zasebno.
The safety and efficacy in children (below the age of 18 years) has not been studied.
Sigurnost primjene i djelotvornost u djece (mlađe od 18 godina) nisu ispitivane.