natgillin/translations-raw huggingface dataset:
• Hold the syringe with the water vial upside down and pull the plunger to draw the water into the syringe.
• Obrnite brizgo skupaj z vialo z vodo na glavo in potegnite bat nazaj, tako da potegnete vodo v brizgo.
• Remove the empty water vial by tipping the syringe with the vial adapter.
• Odstranite prazno vialo z vodo, tako da nagnete brizgo skupaj z adapterjem za vialo.
• Click the vial adapter, still attached to the syringe, onto the powder vial.
• Vialo s praškom vstavite v adapter za vialo, ki je še vedno na brizgi.
Push the plunger slowly to inject the water into the powder vial.
Počasi potiskajte bat in tako vbrizgajte vodo v vialo s praškom.
Make sure not to aim the stream of water directly at the NovoSeven powder as this will cause foaming.
Pazite, da ne boste vodnega curka usmerili neposredno na prašek, ker bi s tem povzročili penjenje.
9 reconstituted NovoSeven in plastic syringes.
9 Pripravljena raztopina NovoSeven je brezbarvna in jo je treba pred uporabo pregledati, da ne vsebuje delcev in da ni obarvana.
It is recommended to use NovoSeven immediately after reconstitution.
Priporočljivo je, da NovoSeven uporabite takoj po pripravi.
• Unscrew the vial adapter with the empty vial.
• Odvijte adapter za vialo skupaj s prazno vialo.
• NovoSeven is now ready for injection.
• Zdravilo NovoSeven je tako pripravljeno za injiciranje.
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 NovoSeven v veno, ne da bi iglo odstranili z mesta injiciranja.
Safely dispose of the syringe, vial adapter, vials, infusion set and any unused product.
Varno zavrzite brizgo, adapter za vialo, obe viali, infuzijski komplet in morebitno neuporabljeno zdravilo.
23 February 1996 Date of latest renewal:
23. februar 1996 Datum zadnjega podaljšanja dovoljenja za promet:
NovoSeven 2.4 mg (120 KIU) - powder and solvent for solution for injection
NovoSeven 2, 4 mg (120 k. i. e.) – prašek in vehikel za raztopino za injiciranje
NovoSeven is presented as powder and solvent for solution for injection containing 2.4 mg eptacog alfa (activated) per vial (corresponds to 120 KIU/ vial).
Zdravilo NovoSeven je na voljo kot prašek in vehikel za raztopino za injiciranje in vsebuje 2, 4 mg aktiviranega eptakoga alfa na vialo (ustreza 120 k. i. e. / vialo).
The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
Aplicira se ga v intravenski bolusni injekciji.
11 Dosing in children Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
11 Trenutne klinične izkušnje ne zahtevajo splošno drugačnega odmerjanja pri otrocih in pri odraslih, čeprav je očistek pri otrocih hitrejši kot pri odraslih.
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.
Ko je dosežena hemostaza, je mogoče odmerni interval postopno podaljševati na vsake 4, 6, 8 ali 12 ur za toliko časa, kot je indicirano zdravljenje
12 Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
Odmerek, odmerno območje in odmerni interval Priporočeno odmerno območje za zdravljenje in preprečevanje krvavitev pri bolnikih, 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.
Glanzmann’ s thrombasthenia
12 Glanzmannova trombastenija
Method of adminsitration
Način uporabe
Patients
V primeru šoka uporabite standardne ukrepe za zdravljenje šoka.
13 should be informed of the early signs of hypersensitivity reactions.
Bolnika morate seznaniti z zgodnimi znaki preobčutljivostnih reakcij.
If bleeding is not kept under control hospital care is mandatory.
13 Če krvavitve ni moč obvladati, je obvezno zdravljenje v bolnišnici.
Cardiac disorders
Bolezni krvi in limfatičnega sistema Zelo redko (< 1/ 10. 000)
14 Very rare (< 1/ 10,000)
Bolnike, ki jih posebej ogroža diseminirana intravaskularna koagulacija, kot je opisano v poglavju 4. 4, je treba natančno nadzirati.
Myocardial infarction:
Srčne bolezni
Gastrointestinal disorders
Zelo redko (< 1/ 10. 000)
Very rare (< 1/ 10,000)
14 Bolezni prebavil Zelo redko (< 1/ 10. 000)
Very rare (< 1/ 10,000)
Sicer ni pričakovati, da bi NovoSeven povzročil krvavitev, vendar se lahko obstoječa krvavitev nadaljuje, če učinkovitost ni zadostna ali shema odmerjanja ni optimalna.
In the vast majority of cases the patients were predisposed to arterial thrombotic disorders either due to underlying disease, age, atherosclerotic or current medical conditions as described in section 4.4. – Venous thrombotic events such as thrombophlebitis, deep vein thrombosis and hereto related pulmonary embolism.
- venski trombotični dogodki, npr. tromboflebitis, globoka venska tromboza in s tem povezana
Patients at increased risk of venous thrombotic disorders either due to concurrent conditions, previous history of thrombotic events, post surgery immobilisation or venous catheterisation should be carefully monitored. – Thrombotic events of the liver.
Bolnike, ki imajo zvečano tveganje za venske trombotične motnje, bodisi zaradi sočasnih bolezni, anamneze trombotičnih dogodkov, pooperacijske imobilizacije ali venske katetrizacije, je treba natančno nadzirati;
15 One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of NovoSeven.
15 Spontano je bil prijavljen en primer angionevrotičnega edema po uporabi zdravila NovoSeven pri bolniku z Glanzmannovo trombastenijo.
Using the FVIIa assay, the pharmacokinetic properties of NovoSeven were studied in 12 paediatric (2 - 12 years) and 5 adult patients in non bleeding state.
Farmakokinetične lastnosti zdravila NovoSeven so s preizkusom z FVIIa raziskali pri 12 pediatričnih (2– 12 let) in 5 odraslih bolnikih, ki niso krvaveli.
16 Single dose pharmacokinetics of NovoSeven, 15 and 30 μ g per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/ h. kg), volume of distribution at steady state (280 - 290 ml/ kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h).
16 Farmakokinetika posamičnih odmerkov zdravila NovoSeven 15 in 30 µg na kg telesne mase se med odmerkoma ni značilno razlikovala po parametrih, neodvisnih od odmerka: skupnem telesnem očistku (70, 8– 79, 1 ml / kg. h), volumnu porazdelitve v stanju dinamičnega ravnovesja (280– 290 ml/ kg), povprečnem času zadrževanja (3, 75– 3, 80 ure) in razpolovnem času (2, 82– 3, 11 ure).
6.4 Special precautions for storage
NovoSeven shranjujte v hladilniku (pri temperaturi med 2 °C in 8 °C).
17 The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
17 Zaprte viale so opremljene z zaščitnim odlomnim pokrovčkom iz polipropilena.
The NovoSeven package contains: – 1 vial (5 ml) with white powder (NovoSeven) for solution for injection – 1 vial (5 ml) with solvent (Water for injections) for reconstitution – 1 sterile vial adapter for reconstitution – 1 sterile disposable syringe for reconstitution and administration – 1 sterile infusion set for administration – 2 alcohol swabs for cleansing the rubber stoppers on the vials – Package leaflet with instructions for use.
Pakiranje NovoSeven vsebuje:
6.6 Special precautions for disposal and other handling
- 1 vialo (5 ml) z belim praškom (NovoSeven) za raztopino za injiciranje,
Always use an aseptic technique
- 1 vialo (5 ml) z vehiklom (voda za injiciranje) za pripravo,
Clean the rubber stoppers on the vials with the alcohol swabs and allow them to dry before use.
Pustite, da se pred uporabo posušita.
• Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
• Z nastavka za vialo odstranite zaščitni papir, vendar nastavka ne vzemite iz zaščitnega pokrovčka.
NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter and discolouration prior to administration.
18 Pripravljena raztopina NovoSeven je brezbarvna in jo je treba pred uporabo pregledati, da ne vsebuje delcev in da ni obarvana.
18 The enclosed disposable syringe is compatible with the reconstituted preparation, but do not store reconstituted NovoSeven in plastic syringes.
Priložena brizga za enkratno uporabo je združljiva s pripravljenim zdravilom, vendar pa pripravljene raztopine NovoSeven ne shranjujte v plastičnih brizgah.
NovoSeven 4.8 mg (240 KIU) - powder and solvent for solution for injection
NovoSeven 4, 8 mg (240 k. i. e.) – prašek in vehikel za raztopino za injiciranje
NovoSeven is presented as powder and solvent for solution for injection containing 4.8 mg eptacog alfa (activated) per vial (corresponds to 240 KIU/ vial).
Zdravilo NovoSeven je na voljo kot prašek in vehikel za raztopino za injiciranje in vsebuje 4, 8 mg aktiviranega eptakoga alfa na vialo (ustreza 240 k. i. e. / vialo).
20 Dosing in children Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
20 Odmerjanje pri otrocih Trenutne klinične izkušnje ne zahtevajo splošno drugačnega odmerjanja pri otrocih in pri odraslih, čeprav je očistek pri otrocih hitrejši kot pri odraslih.
21 Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
21 Priporočeno odmerno območje za zdravljenje in preprečevanje krvavitev pri bolnikih, 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.
Reconstitute the solution as described under section 6.6 and administer as an intravenous bolus injection over 2 - 5 minutes.
Raztopino pripravite kot je opisano v poglavju 6. 6, in jo aplicirajte v 2 - do 5- minutni intravenski bolusni injekciji.
22 should be informed of the early signs of hypersensitivity reactions.
Bolnika morate seznaniti z zgodnimi znaki preobčutljivostnih reakcij.
In case of severe bleeds the product should be administered in hospitals preferably specialized in treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible in close collaboration with a physician specialized in haemophilia treatment.
22 V primeru hudih krvavitev je treba zdravilo aplicirati v bolnišnici, po možnosti tam, kjer so specializirani za zdravljenje bolnikov s hemofilijo z zaviralci koagulacijskih faktorjev VIII in IX – če to ni mogoče, pa v tesnem sodelovanju z zdravnikom, specializiranim za zdravljenje hemofilije.
23 Very rare (< 1/ 10,000)
Srčne bolezni
Myocardial infarction:
23 Zelo redko (< 1/ 10. 000)
Described below under ‘ serious adverse reactions reported during the post-marketing period’.
Miokardni infarkt: glejte opis spodaj pod "Resni neželeni učinki, opisani med pomarketinškim obdobjem".
In two patients the antibodies showed inhibitory effect in vitro.
Pri dveh bolnikih so imela protitelesa zaviralen
24 One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of NovoSeven.
Bolnike s pomanjkanjem faktorja VII je treba nadzirati glede prisotnosti protiteles proti temu faktorju.
Factor VII deficiency
25 Pomanjkanje faktorja VII
25 Single dose pharmacokinetics of NovoSeven, 15 and 30 μ g per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/ h. kg), volume of distribution at steady state (280 - 290 ml/ kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h).
Farmakokinetika posamičnih odmerkov zdravila NovoSeven 15 in 30 µg na kg telesne mase se med odmerkoma ni značilno razlikovala po parametrih, neodvisnih od odmerka: skupnem telesnem očistku (70, 8– 79, 1 ml/ kg. h), volumnu porazdelitve v stanju dinamičnega ravnovesja (280– 290 ml/ kg), povprečnem času zadrževanja (3, 75– 3, 80 ure) in razpolovnem času (2, 82– 3, 11 ure).
26 The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
26 Viale z zdravilom NovoSeven: steklene, zaprte z zamaškom iz brombutilne gume, prekritim z aluminijsko zaporko.
Vials for solvent:
Zaprte viale so opremljene z zaščitnim odlomnim pokrovčkom iz polipropilena.
The NovoSeven package contains: – 1 vial (12 ml) with white powder (NovoSeven) for solution for injection – 1 vial (12 ml) with solvent (Water for injections) for reconstitution – 1 sterile vial adapter for reconstitution – 1 sterile disposable syringe for reconstitution and administration – 1 sterile infusion set for administration – 2 alcohol swabs for cleansing the rubber stoppers on the vials – Package leaflet with instructions for use.
Pakiranje NovoSeven vsebuje:
6.6 Special precautions for disposal and other handling
- 1 vialo (12 ml) z belim praškom (NovoSeven) za raztopino za injiciranje,
Always use an aseptic technique
- 1 vialo (12 ml) z vehiklom (voda za injiciranje) za pripravo,
• Gently swirl the vial until all the powder is dissolved.
27 • Previdno vrtite vialo, dokler se prašek ne raztopi.
NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter and discolouration prior to administration.
Pripravljena raztopina NovoSeven je brezbarvna in jo je treba pred uporabo pregledati, da ne vsebuje delcev in da ni obarvana.
27 The enclosed disposable syringe is compatible with the reconstituted preparation, but do not store reconstituted NovoSeven in plastic syringes.
Priložena brizga za enkratno uporabo je združljiva s pripravljenim zdravilom, vendar pa pripravljene raztopine NovoSeven ne shranjujte v plastičnih brizgah.
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection
NovoSeven 1 mg (50 k. i. e.) prašek in topilo za raztopino za injiciranje
NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/ vial).
Zdravilo NovoSeven je na voljo kot prašek in topilo za raztopino za injiciranje in vsebuje 1 mg aktiviranega eptakoga alfa na vialo (ustreza 50 k. i. e. / vialo).
eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Dalton produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.
Aktivirani eptakog alfa je rekombinantni koagulacijski faktor VIIa (rFVIIa) z molekulsko maso približno 50. 000 daltonov, pridobljen z rekombinantno DNA tehnologijo iz ledvičnih celic hrčkovega mladiča (celice BHK - baby hamster kidney cells).
After reconstitution, the product contains 1 mg/ ml eptacog alfa (activated) and 10 mg/ ml sucrose when reconstituted with solvent.
Po rekonstituciji s topilom vsebuje zdravilo 1 mg/ ml aktiviranega eptakoga alfa in 10 mg/ ml saharoze.
Powder and solvent for solution for injection.
Prašek in topilo za raztopino za injiciranje.
White lyophilized powder.
Bel liofiliziran prašek.
The reconstituted solution has a pH of approximately 6.0.
Pripravljena raztopina ima pH približno 6, 0.
Posology 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
The recommended initial dose, administered by intravenous bolus injection, is 90 μ g per kg body weight.
Priporočeni začetni odmerek je 90 μg na kg telesne mase.
Following the initial dose of NovoSeven further injections may be repeated.
Aplicira se ga v intravenski bolusni injekciji.
29 procedures or surgery being performed.
29 Po začetnem odmerku zdravila NovoSeven se lahko uporabijo dodatne injekcije.
Dosing in children Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
Odmerjanje pri otrocih Trenutne klinične izkušnje ne zahtevajo splošno drugačnega odmerjanja pri otrocih in pri odraslih, čeprav je očistek pri otrocih hitrejši kot pri odraslih.
30 Factor VII deficiency
Pomanjkanje faktorja VII
Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
30 Odmerek, odmerno območje in odmerni interval Priporočeno odmerno območje za zdravljenje in preprečevanje krvavitev pri bolnikih, 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.
If allergic or anaphylactic-type reactions occur, the administration should be discontinued
Če se pojavi alergijska ali anafilaktična reakcija, morate uporabo zdravila nemudoma prekiniti.
In case of shock, standard medical treatment for shock should be implemented.
31 simptomov nemudoma prenehati uporabljati zdravilo in se mora posvetovati z zdravnikom.
Patients with rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose- isomaltase insufficiency should not take this medicine
Bolniki z redkimi prirojenimi motnjami, kot so intoleranca za fruktozo, malabsorpcija glukoze ali pomanjkanje saharaze- izomaltaze, ne smejo jemati tega zdravila.
Patients at increased risk of
Bolnike, ki jih posebej ogroža
32 disseminated intravascular coagulation as described in section 4.4 should be carefully monitored.
32 diseminirana intravaskularna koagulacija, kot je opisano v poglavju 4. 4, je treba natančno nadzirati.
Cardiac disorders Very rare (< 1/ 10,000)
Srčne bolezni Zelo redko (< 1/ 10. 000)
33 There have been no reports of antibodies against factor VII in haemophilia A or B patients.
Pri bolnikih s hemofilijo A ali B niso poročali o protitelesih proti faktorju VII.
Isolated cases of factor VII deficient patients developing antibodies against factor VII have been reported after treatment with rFVIIa.
33 Opisani so posamezni primeri bolnikov s pomanjkanjem faktorja VII, ki so se jim po zdravljenju z rFVIIa pojavila protitelesa proti faktorju VII.
These patients have previously been treated with human plasma and/ or plasma- derived factor VII.
Ti bolniki so bili predhodno zdravljeni s človeško plazmo in/ ali faktorjem VII, pridobljenim iz plazme.
One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of rFVIIa.
Spontano je bil prijavljen en primer angionevrotičnega edema po uporabi rFVIIa pri bolniku z Glanzmannovo trombastenijo.
B02BD08
B02BD08.
Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight and/ or placebo (3 doses each).
Dobili so 40, 80 in 160 µg rFVIIa na kilogram telesne mase in/ ali placebo (3 odmerke vsakega).
Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (2 - 12 years) and 5 adult patients in non bleeding state.
Farmakokinetične lastnosti rFVIIa so s preizkusom z FVIIa raziskali pri 12 pediatričnih (2– 12 let) in 5 odraslih bolnikih, ki niso krvaveli.
Mean volume of distribution at steady state was 196 ml/ kg in
Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja je
34 paediatric patients versus 159 ml/ kg in adults.
34 bil pri pediatričnih bolnikih 196 ml/ kg in pri odraslih 159 ml/ kg.
Single dose pharmacokinetics of rFVIIa, 15 and 30 μ g per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/ h. kg), volume of distribution at steady state (280 - 290 ml/ kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h).
Farmakokinetika posamičnih odmerkov rFVIIa 15 in 30 µg na kg telesne mase se med odmerkoma ni značilno razlikovala po parametrih, neodvisnih od odmerka: skupnem telesnem očistku (70, 8– 79, 1 ml / kg. h), volumnu porazdelitve v stanju dinamičnega ravnovesja (280– 290 ml/ kg), povprečnem času zadrževanja (3, 75– 3, 80 ure) in razpolovnem času (2, 82– 3, 11 ure).
Powder Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Sucrose Methionine Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Prašek natrijev klorid kalcijev klorid dihidrat glicilglicin polisorbat 80 manitol saharoza metionin klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
Solvent Histidine Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Topilo histidin klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
The shelf life is 2 years for the product packed for sale.
Rok uporabnosti zdravila, pakiranega za prodajo, je 2 leti.
After reconstitution, chemical and physical stability have 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.
35 6.4 Special precautions for storage
35
– Store powder and solvent below 25°C. – Store powder and solvent protected from light. – Do not freeze to prevent damage to the solvent vial. – For storage conditions of the reconstituted medicinal product, see section 6.3.
- Prašek in topilo shranjujte pri temperaturi do 25 °C.
6.5 Nature and contents of container
- Prašek in topilo shranjujte zaščiteno pred svetlobo.
The NovoSeven package contains Type I glass vials closed with a chlorobutyl rubber stopper, covered with an aluminium cap. The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
- Ne zamrzujte, da boste preprečili poškodbo viale s topilom.
Each NovoSeven package contains: – 1 vial (2 ml) with white powder for solution for injection – 1 vial (2 ml) with solvent for reconstitution
- Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6. 3.
6.6 Special precautions for disposal and other handling
6. 5 Vrsta ovojnine in vsebina
Always use an aseptic technique
Vedno uporabljajte aseptičen postopek.
Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Pustite, da se pred uporabo posušita.
Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.
Uporabite primerno veliko brizgo za enkratno uporabo ter nastavek za vialo, iglo za prenos (20– 26 G) ali drug ustrezen pripomoček.
• Attach the vial adapter to the solvent vial.
• Nastavek za vialo namestite na vialo s topilom.
• Hold the syringe with the solvent vial upside down.
• Obrnite brizgo skupaj z vialo s topilom na glavo.
Do not store reconstituted NovoSeven in plastic syringes.
Priporočljivo je, da NovoSeven uporabite takoj po pripravi.
36 It is recommended to use NovoSeven immediately after reconstitution.
36 Aplikacija
NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection
NovoSeven 2 mg (100 k. i. e.) prašek in topilo za raztopino za injiciranje
NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/ vial).
Zdravilo NovoSeven je na voljo kot prašek in topilo za raztopino za injiciranje in vsebuje 2 mg aktiviranega eptakoga alfa na vialo (ustreza 100 k. i. e. / vialo).
After reconstitution, the product contains 1 mg/ ml eptacog alfa (activated) and 10 mg/ ml sucrose when reconstituted with solvent.
Po rekonstituciji s topilom vsebuje zdravilo 1 mg / ml aktiviranega eptakoga alfa in 10 mg/ ml saharoze.
The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
Priporočeni začetni odmerek je 90 μg na kg telesne mase.