natgillin/translations-raw huggingface dataset:
During storage, the product may be kept at:
V času do izteka roka uporabnosti se zdravilo lahko shranjuje pri:
Adolescents <18 years) PTP
Mladostniki < 18 let) PZB
For storage conditions of the reconstituted medicinal product see section 6.3.
Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6.3.
Anti factor VIII antibody positive
Zaviralci faktorja VIII
NovoEight is supplied as a powder.
Zdravilo NovoEight je na voljo kot prašek.
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Med zdravljenjem je priporočljivo z ustreznimi testi določati aktivnost faktorja VIII, da se ugotovi potreben odmerek in pogostnost aplikacij.
Younger children
Mlajši otroci
The reconstituted solution will be clear to slightly opalescent.
Pripravljena raztopina bo bistra do rahlo opalescentna (rahlo motna).
These devices are not included in the NovoEight package.
Pakiranje zdravila NovoEight teh pripomočkov ne vsebuje.
It is recommended to use NovoEight immediately after reconstitution.
Priporočljivo je, da zdravilo NovoEight uporabite takoj po pripravi.
• 24 hours stored at 2°C - 8°C
• 24 ur v primeru shranjevanja pri temperaturi 2 °C - 8 °C,
Injecting NovoEight via needleless connectors for intravenous (IV) catheters
Injiciranje zdravila NovoEight preko brezigelnih konektorjev za intravenske (i.v.)
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
aktivirani parcialni tromboplastinski čas) za določanje aktivnosti faktorja VIII v vzorcih krvi bolnikov, lahko na rezultate aktivnosti plazemskega faktorja VIII občutno vpliva tako tip aPTČ reagenta kot tudi referenčni standard, uporabljen pri preizkušanju.
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Število apliciranih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), trenutnim standardom
• bleeding in muscle tissue
• krvavitev v mišičnem tkivu
- The ingredients in the solvent are sodium chloride and water for injections.
- Sestavini vehikla sta natrijev klorid in voda za injekcije.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Bolnike je treba seznaniti z zgodnjimi znaki preobčutljivostnih reakcij, vključno s koprivnico, generalizirano urtikarijo, tiščanjem v prsih, piskajočim dihanjem,
Do not touch the syringe tip.
• Ne dotikajte se konice brizge.
Do not use any other way to heat the vial and pre-filled syringe.
• Za gretje viale in napolnjene injekcijske brizge ne uporabljajte nobenega drugega načina.
Push the plunger rod slowly until all air bubbles are gone.
Nosilec bata počasi potiskajte, dokler ne izginejo vsi zračni mehurčki.
Do not use this medicine after the expiry date, which is stated after ‘EXP' on the carton and on the vial and the pre-filled syringe labels.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, viali in nalepki napolnjene injekcijske brizge poleg oznake »EXP«.
Adults (≥18 years) PTP
Odrasli (≥ 18 let)
• pain in muscles
• togost v mišicah
Psychiatric disorders Uncommon
Psihiatrične motnje občasni nespečnost
The potency (IU) is determined using the European Pharmacopoeia (Ph. Eur) chromogenic assay.
Jakost (i.e.) je določena z uporabo kromogenega preizkusa po Evropski farmakopeji (Ph.
<12 years) PTP
< 12 let) PZB
Severe symptoms, including difficulty in swallowing or breathing and red or swollen face or hands, require prompt emergency treatment.
Hudi simptomi, vključno s težavami pri požiranju ali dihanju in pordelost ali oteklost obraza ali rok,
Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Držite nosilec bata do konca pritisnjen in previdno vrtite vialo, dokler se ves prašek ne raztopi.
How to use NovoEight
Kako uporabljati zdravilo NovoEight
Any unused reconstituted product stored at room temperature (≤30°C) or up to 40°C for more than 4 hours should be discarded.
Neporabljeno pripravljeno zdravilo, ki je več kot 4 ure shranjeno pri sobni temperaturi (≤ 30 °C) oz. pri temperaturi do 40 °C, je treba v celoti zavreči.
Novo Nordisk US Bio Production Inc. 9 Technology Drive West Lebanon
Velika Britanija Novo Nordisk US Bio Production Inc.
After reconstitution the solution appears as a clear or slightly opalescent solution.
Po pripravi je raztopina bistra ali rahlo opalescentna.
After reconstitution with the supplied solvent (sodium chloride 9 mg/ml (0.9%) solution for injection), the prepared solution for injection contains 62.5, 125, 250, 375, 500 or 750 IU turoctocog alfa per ml, respectively, (based on the strength of turoctocog alfa, i.e. 250, 500, 1000, 1500, 2000 or 3000 IU).
pripravljena raztopina za injiciranje vsebuje 62,5, 125, 250, 375, 500 ali 750 i.e. turoktokoga alfa na ml (glede na jakost turoktokoga alfa, tj. 250, 500, 1.000, 1.500, 2.000 ali 3.000 i.e.).
Vial adapter Protective cap
nastavek za vialo zaščitni pokrovček konica
This is because if left, the medicine may no longer be sterile and could cause infections.
Če namreč zdravilo ni uporabljeno takoj, lahko ni več sterilno in bi lahko povzročilo okužbo.
The maximum exposure (Cmax) and the total exposure (AUC) increase with increasing BMI indicating that dose adjustments may be required for underweight (BMI <18.5 kg/m2) and obese patients (BMI ≥30 kg/m2), see section 4.2.
Največja izpostavljenost (Cmax) in skupna izpostavljenost (AUC) sta naraščala z naraščanjem ITM, kar kaže na morebitno potrebo po prilagoditvi odmerka pri bolnikih s premajhno telesno maso (ITM < 18,5 kg/m2) in pri debelih bolnikih (ITM ≥ 30 kg/m2).
Do not lift the vial adapter from the vial when removing the protective cap.
Pazite, da ne dvignete nastavka za vialo z viale, ko odstranite zaščitni pokrovček.
Bring the vial and the pre-filled syringe to room temperature.
Ogrejte vialo in napolnjeno injekcijsko brizgo na sobno temperaturo.
Incremental recovery (IU/dl)/(IU/kg)
Inkrementno okrevanje (i.e./dl)/(i.e./kg)
Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Prenehajte pritiskati nosilec bata in pustite, da se sam od sebe pomika nazaj, medtem ko pripravljena raztopina polni brizgo.
The single dose pharmacokinetic parameters of NovoEight are listed in Table 4 for the one-stage clotting assay and in Table 5 for the chromogenic assay.
Farmakokinetični parametri enkratnega odmerka zdravila NovoEight z enostopenjskim preizkusom strjevanja so prikazani v preglednici 4, s kromogenim preizkusom pa v preglednici 5.
• joint disease
• bolezen sklepov
Method of administration Intravenous use.
Za intravensko uporabo.
Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to air dry for a few seconds before use.
• Obrišite gumijasti zamašek s sterilnim alkoholnim lističem in pustite nekaj sekund, da se na zraku posuši, preden vialo uporabite.
More extensive haemarthrosis, muscle bleeding or haematoma
obsežnejša hemartroza, krvavitev v mišico ali hematom
Before the NovoEight powder is reconstituted it may be kept at:
Pred pripravo lahko prašek zdravila NovoEight shranjujete pri:
Treatment should be under the supervision of a doctor experienced in the treatment of haemophilia.
4.2 Odmerjanje in način uporabe Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
The following table can be used to guide dosing in bleeding episodes and surgery:
Spodnjo preglednico je mogoče uporabiti kot vodilo za odmerjanje pri krvavitvah in kirurških posegih.
NovoEight is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Zdravilo NovoEight je treba aplicirati intravensko po pripravi praška z vehiklom, priloženim v brizgi.
Cardiovascular event
Srčno-žilni dogodki
• blood tests showing changes in the way the liver functions • reactions (redness and itching) around the site where you injected the medicine.
• reakcije (rdečica in srbečica) okoli mesta, kjer ste injicirali zdravilo
The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
(faktorja VIII in von Willebrandovega faktorja), ki imata različni fiziološki funkciji.
The solvent is a sodium chloride 9 mg/ml (0.9%) solution.
Vehikel je 9 mg/ml (0,9 %) raztopina natrijevega klorida.
Store in the original package in order to protect from light
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
<6 years) PTP
< 6 let) PNB
Once you have reconstituted NovoEight it should be used right away.
Ko je zdravilo NovoEight enkrat pripravljeno, ga je treba uporabiti takoj.
Check the reconstituted solution.
• Preverite pripravljeno raztopino.
NovoEight 2000 IU
NovoEight 2000 i.e.
Unopened vial 30 months when stored in a refrigerator (2°C - 8°C).
30 mesecev, če se zdravilo shranjuje v hladilniku (2 °C - 8 °C).
NovoEight 250 IU powder and solvent for solution for injection NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection
NovoEight 250 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 2000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 3000 i.e. prašek in vehikel za raztopino za injiciranje
• pain in legs and arms
• bolečine v mišicah • bolečine v nogah in rokah
While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Medtem ko držite vialo obrnjeno na glavo, previdno potrkajte brizgo, da se bodo zračni mehurčki dvignili na vrh.
Do not touch the syringe tip under the syringe cap.
Ne dotikajte se konice brizge pod pokrovčkom brizge.
Rubber stopper (under plastic cap)
(pod plastičnim pokrovčkom)
Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Hemofilija A je na spol vezana dedna motnja strjevanja krvi zaradi pomanjkanja faktorja VIII:C. Povzroči obsežne krvavitve v sklepe, mišice ali notranje organe.
NovoEight contains sodium
Zdravilo NovoEight vsebuje natrij
The following side effects may occur with this medicine.
Med uporabo tega zdravila se lahko pojavijo neželeni učinki, navedeni v nadaljevanju.
Do not dispose of any of the items until after you have injected the reconstituted solution.
Ne zavrzite ničesar, dokler si pripravljene raztopine ne injicirate.
Take the vial, the vial adapter and the pre-filled syringe out of the carton.
Vzemite vialo, nastavek za vialo in napolnjeno injekcijsko brizgo iz škatle.
Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved
3 do 4 dni ali več, dokler bolečina in akutna prizadetost ne mineta.
If you touch the syringe tip, germs from your fingers can be transferred.
Če se dotaknete konice brizge, lahko nanjo prenesete klice s prstov.
Flushing, Thrombophlebitis superficial
hiperemija pogosti zardevanje, površinski tromboflebitis
If the plastic cap is loose or missing, do not use the vial.
Če plastični pokrovček ni trdno pričvrščen ali ga ni, viale ne uporabite.
Prepare the vial and the syringe Take out the number of NovoEight packages you need.
• Vzemite toliko pakiranj zdravila NovoEight, kot jih potrebujete.
Underweight N=5
Premajhna telesna masa N=5
NovoEight 1500 IU
NovoEight 1500 i.e.
Overweight N=9
Prekomerna telesna masa N=9
For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Pri bolnikih, ki pa so se predhodno zdravili z zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), lahko zaviralna protitelesa nastanejo občasno (pri manj kot 1 od 100 bolnikov).
0 − <6 years 6 − <12 years ≥12 years n=14
≥ 12 let n = 14
L) Unscrew the vial adapter with the vial.
L) Odvijte nastavek za vialo skupaj z vialo.
• increased blood pressure
• hitro bitje srca • zvišanje krvnega tlaka
Table 2 Frequency of adverse drug reactions in clinical trials
Pogostnost neželenih učinkov v kliničnih preskušanjih Organski sistem
You should contact your doctor if you have missed a dose and do not know how to compensate for this.
Če ste pozabili uporabiti zdravilo NovoEight Če ste pozabili uporabiti odmerek in ne veste, kako ga nadomestiti, se posvetujte z zdravnikom.
Please record the beginning of storage and the storage temperature on the product carton.
Na škatlo zdravila zapišite začetek shranjevanja izven hladilnika in temperaturo zraka v prostoru shranjevanja.
By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of bleeding tendencies.
Tako se začasno popravi pomanjkanje faktorja VIII in se zmanjša nagnjenost h krvavitvam.
The expiry date is printed after ‘EXP' on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe.
Datum izteka roka uporabnosti je natisnjen na škatli in na viali, na nastavku za vialo in na napolnjeni injekcijski brizgi poleg oznake »EXP«.
Inject the reconstituted solution
Injicirajte pripravljeno raztopino
If the syringe cap is loose or missing, do not use the pre-filled syringe.
Če pokrovček brizge ne sedi trdno ali ga ni, napolnjene injekcijske brizge ne uporabite.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Prašek:
NovoEight 250 IU
NovoEight 250 i.e.
• room temperature (≤ 30°C) for a single period no longer than 9 months or
• pri sobni temperaturi (≤ 30 °C) za enkratno obdobje, ki ni daljše od 9 mesecev, ali
Table 1 Guide for dosing in bleeding episodes and surgery
Smernice za odmerjanje pri krvavitvah in kirurških posegih
AUC ((IU*h)/dl) 1510 (360) 1920 (610) CL (ml/h/kg) t½ (h)
AUC ((i.e.*h)/dl) 1.510 (360) 1.920 (610)
Remove the syringe cap from the pre filled syringe by bending it down until the perforation breaks.
Odstranite pokrovček brizge z napolnjene injekcijske brizge tako, da ga upognete, dokler se perforacija ne pretrga.
A single dose pharmacokinetic trial (50 IU/kg) was performed in 35 haemophilia patients (≥18 years of age) in different BMI categories.
Pri 35 bolnikih s hemofilijo (starih ≥ 18 let), ki so bili razvrščeni v različne kategorije ITM, je bilo izvedeno farmakokinetično preskušanje z enkratnim odmerkom (50 i.e./kg).
This glycoprotein has the same structure as human factor VIII when activated, and posttranslational modifications that are similar to those of the plasma-derived molecule.
Zdravilo NovoEight vsebuje turoktokog alfa, humani koagulacijski faktor VIII (rDNA) s ciljno skrajšano domeno B. Ko je aktiviran, ima ta glikoprotein enako zgradbo kot humani faktor VIII in posttranslacijske spremembe, ki so podobne kot pri molekuli, pridobljeni iz plazme.
Push the plunger rod to inject all the solvent into the vial.
• Potisnite nosilec bata, da boste v vialo vbrizgali celotno količino vehikla.
Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 ml solvent in pre-filled syringe, plunger rod and vial adapter
Pakiranje vsebuje: 1 vialo s praškom, 4 ml vehikla v napolnjeni injekcijski brizgi, nosilec bata in nastavek za vialo.
NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
NovoEight 500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 2000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 3000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
An updated RMP should be submitted:
Navodilo je bilo nazadnje posodobljeno:
Excipient with known effect The medicinal product contains 30.5 mg sodium per reconstituted vial.
Zdravilo po pripravi vsebuje 30,5 mg natrija na vialo.
1 pre-filled syringe with solvent 1 plunger rod (placed under the syringe)
• 1 nosilec bata (nameščen je pod brizgo).
Vss (ml/kg)
Vss (ml/kg) Cmax (i.e./dl)
Grasp the plunger rod by the wide top and immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
F) Primite nosilec bata za široki zgornji del in ga takoj privijte v brizgo tako, da ga sučete v smeri urinega kazalca v bat, ki je v napolnjeni injekcijski brizgi, dokler ne začutite upora.
Attach the vial adapter Remove the protective paper from the vial adapter.
Namestite nastavek za vialo • Odstranite zaščitni papir z nastavka za vialo.
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT.
Navodila za uporabo zdravila NovoEight PRED UPORABO ZDRAVILA NOVOEIGHT NATANČNO PREBERITE TA NAVODILA.
Number of patients Dose used for prevention per patient (IU/kg BW) Mean (SD) Min ; Max Dose used for treatment of bleed (IU/kg BW)
Odmerek, uporabljen za preprečevanje krvavitev na bolnika (i.e./kg TM)
If you stop using NovoEight
Ne prenehajte uporabljati zdravila NovoEight,
Musculoskeletal stiffness, arthropathy, pain in extremity, musculoskeletal pain
Bolezni mišično skeletnega sistema in vezivnega tkiva občasni mišično-skeletna togost, artropatija, bolečina v okončini, mišičnoskeletne bolečine pogosti hemartroza, krvavitev v mišici
Talk to your doctor before using NovoEight.
Pred začetkom uporabe zdravila NovoEight se posvetujte z zdravnikom.
Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid Solvent: Sodium chloride, water for injections
SEZNAM POMOŽNIH SNOVI Prašek: natrijev klorid, L-histidin, saharoza, polisorbat 80, L-metionin, kalcijev klorid dihidrat,
Obese class II/III N=7
razred II/III
Keep the plunger rod pushed completely in.
Držite nosilec bata potisnjen do konca.
NovoEight 3000 IU
NovoEight 3000 i.e.
When you prepare and inject medicine directly into the veins, it is important to use a clean and germ free (aseptic) technique.
Pomembno je, da med pripravo in injiciranjem zdravila neposredno v veno uporabljate čist postopek brez prisotnosti klic (aseptičen postopek).
• If the CVAD line needs to be flushed before or after NovoEight injection, use sodium chloride 9 mg/ml solution for injection.
• Če je linijo CVAD pred injiciranjem zdravila NovoEight ali po njem treba sprati, uporabite
Turoctocog alfa is a B-domain truncated recombinant human coagulation factor VIII (B-domain consists of 21 amino acids of the wild type B-domain) without any other modifications in the amino acid sequence.
21 aminokislin divjega tipa domene B), brez kakršnih koli drugih sprememb zaporedja aminokislin.
NovoEight is given as an injection into a vein.
Kako uporabljati zdravilo NovoEight Zdravilo NovoEight se daje kot injekcija v veno.
Keep reconstituted NovoEight solution out of direct light.
Pripravljena raztopina zdravila NovoEight naj ne bo izpostavljena neposredni svetlobi.
System Organ Class Frequencya in PTPs
Pogostnosta pri PZB
Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged.
Ne uporabljajte opreme, če vam je padla ali je poškodovana.
• above room temperature (30°C up to 40°C) for a single period no longer than 3 months.
• pri temperaturah, višjih od sobne temperature (30 °C - 40 °C), za enkratno obdobje, ki ni daljše od 3 mesecev.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Intravenous use Read the package leaflet before use
Pred uporabo preberite priloženo navodilo!
Remove the protective paper from the vial adapter.
Odstranite zaščitni papir z nastavka za vialo.
Do not store the solution without your doctor's advice.
Raztopine ne shranjujte, če vam tega ne naroči zdravnik.
Early haemarthrosis, muscle bleeding or oral bleeding
Krvavitev zgodnja hemartroza, krvavitev v mišico oziroma krvavitev v ustni votlini
For long term prophylaxis against bleeding in patients below the age of 12, doses of 25-50 IU of factor VIII per kg body weight every second day or 25-60 IU of factor VIII per kg body weight 3 times weekly are recommended.
faktorja VIII na kg telesne mase vsak drugi dan ali 25-60 i.e. faktorja VIII na kg telesne mase 3-krat na teden.
Headache, dizziness, burning sensation
Bolezni živčevja občasni glavobol, omotica, pekoč občutek
Do not shake the vial as this will cause foaming.
Viale ne stresajte, ker to povzroča penjenje.
NovoEight 500 IU
NovoEight 500 i.e.
Attach the plunger rod and the syringe
Namestite nosilec bata in brizgo
Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Držite napolnjeno injekcijsko brizgo rahlo nagnjeno in tako, da je viala obrnjena navzdol.
PK parameter
Farmakokinetični parameter
Turn the syringe with the vial upside down.
Obrnite brizgo z vialo na glavo.
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Oznaka ATC: B02BD02.
swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.
Zgodnji znaki alergijske reakcije so izpuščaj, koprivnica, srbenje po celem telesu, oteklost ustnic in jezika, težave z dihanjem, piskajoče dihanje, tiščanje v prsih, splošno slabo počutje in omotica.
How to store NovoEight
Shranjevanje zdravila NovoEight
If this happens to you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Če pride do nastanka zaviralnih protiteles, vaše zdravilo ali zdravilo vašega otroka morda ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
Hypertension, lymphoedema, hyperaemia
Žilne bolezni občasni hipertenzija, limfedem,
NovoEight is now ready to be injected into your vein.
Zdravilo NovoEight je zdaj pripravljeno za injiciranje v veno.
The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl.
(i.e.) faktorja VIII na kilogram telesne mase poveča aktivnost faktorja VIII v plazmi za 2 i.e./dl.
Turn over the protective cap and snap the vial adapter onto the vial.
Obrnite zaščitni pokrovček in nataknite nastavek za vialo na vialo.
Each pack of NovoEight contains a vial with white or slightly yellow powder, a 4 ml pre-filled syringe with a clear colourless solution, a plunger rod and a vial adapter.
NovoEight vsebuje vialo z belim do rumenkastim praškom, 4-ml napolnjeno injekcijsko brizgo z bistro, brezbarvno raztopino, nosilec bata in nastavek za vialo.
NH 03784
9 Technology Drive West Lebanon NH 03784
4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C8°C.
Če pripravljene raztopine zdravila NovoEight ne morete uporabiti takoj, jo morate uporabiti v 4 urah, če je shranjena pri sobni temperaturi oz. pri temperaturi, ki ne presega 40 °C, in v 24 urah, če je shranjena pri temperaturi 2 °C - 8 °C.