natgillin/translations-raw huggingface dataset:
Taking other medicines Helicobacter Test INFAI for children of the age 3-11 is influenced by all medicines related to Helicobacter pylori or urease activity.
Nosečnost in dojenje Navedba smiselno ni potrebna.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Vpliv na sposobnost upravljanja vozil in strojev Navedba smiselno ni potrebna.
HOW TO TAKE HELICOBACTER TEST INFAI FOR CHILDREN OF THE AGE 3-11
KAKO UPORABLJATI TEST HELICOBACTER INFAI ZA OTROKE V STAROSTI 3 – 11 LET
Always take Helicobacter Test INFAI for children of the age 3-11 exactly as your doctor has told you.
Pri uporabi zdravila Test Helicobacter INFAI natančno upoštevajte zdravnikova navodila.
You should perform the test in the presence of your doctor or another qualified person.
Test je potrebno izvesti v prisotnosti zdravnika ali druge usposobljene osebe.
Dosage The following information applies, unless your doctor has otherwise prescribed Helicobacter Test INFAI for children of the age 3-11.
Odmerjanje Upoštevajte tukaj navedene podatke, razen če vam zdravnik ni predpisal drugače.
Please follow the instructions for use, as otherwise the Helicobacter Test INFAI for children of the age 3-11 years may not work properly.
Natančno upoštevajte navodila za uporabo, sicer Test Helicobacter INFAI za otroke v starosti 3 – 11 let morda ne bo pravilno
How much Helicobacter Test INFAI for children of the age 3-11 should be used and how often?
Kakšen odmerek uporabimo in kako pogosto?
Patients from the age of 3-11 must take the content of one jar with 45 mg for one test.
Otroci v starosti 3 – 11 let pri enem testnem postopku vzamejo vsebino ene stekleničke (45 mg).
How and when should Helicobacter Test INFAI for children of the age 3-11 be used?
Kako in kdaj uporabimo Test Helicobacter INFAI za otroke v starosti 3 – 11 let?
You must have fasted for 6 hours before application, preferably overnight.
Pred testiranjem se mora otrok postiti vsaj 6 ur, najbolje čez noč.
If fasting is a problem, for example for diabetic patients, please tell your doctor.
Če to povzroča težave (npr. če je vaš otrok diabetik), se posvetujte z zdravnikom.
58 The test should be performed following at least four weeks without antibacterial therapy and two weeks after the last administration of an antisecretory medication.
Test se lahko opravi vsaj 4 tedne po zadnjem zdravljenju z antibiotiki in dva tedna po zadnjem odmerku inhibitorjev izločanja želodčne kisline.
Both of these substances could influence the results of the Helicobacter Test INFAI for children of the age 3-11.
Obe vrsti zdravil lahko vplivata na izid Testa Helicobacter INFAI za otroke v starosti 3 – 11 let.
It is important to follow the instructions for use exactly, otherwise the result may be questionable.
Natančno morate upoštevati navodila za uporabo, sicer bo rezultat vprašljiv.
Essential items not supplied with Helicobacter Test INFAI for children of the age 3-11 Before the breath test is performed a liquid test meal is taken to delay stomach emptying.
Elementi, ki jih potrebujete, vendar niso priloženi kompletu Testa Helicobacter INFAI za otroke v starosti 3 – 11 let Pred testom je potrebno popiti tekoč testni obrok, ki zadržuje praznjenje želodca.
Pure orange juice (100 ml) can be used as a test meal.
Uporabi se lahko čisti pomarančni sok (100 ml).
If there is a medical (or other) reason why you cannot take either of these test meals, please tell your doctor, who will suggest an alternative.
Če ima otrok zdravstvene ali kakšne druge razloge, zaradi katerih tega obroka ne more zaužiti, se posvetujte z zdravnikom, ki bo našel drugo možnost.
Each patient should be documented using the provided data sheet.
Posebna navodila za uporabo Podatke otroka morajo zabeležiti v priloženi formular.
It is recommended that you take the test in a resting position.
Priporočamo, da med opravljanjem testa počiva.
The test should be carried out after having fasted 6 hours before application, preferably overnight.
Pred uporabo testa se je potrebno postiti vsaj 6 ur, najbolje čez noč.
If the test needs to be carried out later in the day, only a light meal like tea and toast is recommended.
Če se test ne opravlja zjutraj, priporočamo lahek obrok kot prepečenec in čaj.
The straw and sample tubes labelled “sampling time:
Iz kompleta je potrebno vzeti slamico in epruveto z napisom "čas vzorčenja:
The stopper is removed from one of the sample containers, the straw unwrapped and placed into the container.
Z epruvete se odstrani zamašek, odvije slamico in jo vstavi v epruveto.
Now the patient breathes gently through the straw into the sample tube until the inside of the sample tube steams up.
Skozi slamico otrok počasi izdihuje v epruveto, dokler se notranja površina epruvete ne zarosi.
The patient must continue to breathe through the straw while removing it from the sample tube and then immediately seal the tube with its stopper.
Medtem ko otrok neprekinjeno izdihuje, je potrebno izvleči slamico iz epruvete in epruveto takoj zapreti z ustreznim zamaškom.
(If the sample tube remains open for more than 30 seconds, the test result might be falsified.)
(Če ostane epruveta odprta dlje kot 30 sekund, bo rezultat testa morda napačen).
The sample container should be held upright and the bar -code label marked 00-minute- value will be stuck round the sample container so that the lines of bar code are horizontal.
Epruveto je potrebno držati pokonci in nanjo nalepiti črtno kodo z oznako "00- minutna vrednost" tako, da so črte v vodoravnem položaju.
Now the second sample container (labelled “sampling time:
Nato mora otrok popiti priporočen obrok (100 ml 100 -% pomarančnega soka).
Then the patient must drink the recommended test meal (100 ml 100% orange juice).
Nato je potrebno plastenko zapreti in previdno stresati, dokler se prašek popolnoma ne raztopi.
•
Otrok
The jar labelled “ 13C-urea powder” is removed from the test set, opened, and filled up to about three quarters with tap water.
mora raztopino nemudoma popiti.
The jar is closed and carefully shaken until all the powder has dissolved completely.
Točen čas zaužitja je potrebno zapisati.
The patient should drink this test solution immediately.
30 minut po zaužitju testne raztopine zberite vzorec "30- minutne vrednosti" v epruveti, ki je še
The time of intake must be noted.
30- minutna vrednost ").
30-minute- value”) as described above.
Ustrezno nalepko s črtno kodo je potrebno nalepiti tudi na podatkovni list vašega otroka.
The bar-code labels marked “30-minute-value” must be used for these samples.
Vse epruvete se namestijo v originalno ovojnino, ki se jo zapre s preostalo nalepko.
The corresponding bar-code label must be put on the data sheet for patient documentation.
Zavoj je potrebno poslati v usposobljen laboratorij, kjer ga bodo analizirali.
The package must be sent to a qualified laboratory for analysis.
Če ste vzeli večji odmerek Testa Helicobacter INFAI za otroke v starosti 3 – 11 let, kot bi smeli V enem odmerku je le 45 mg 13C- sečnine, zato ne pričakujemo možnosti prevelikega odmerjanja.
If you take more Helicobacter Test INFAI for children of the age 3-11 than you should Because only 45 mg 13C-urea is provided overdose is not to be expected.
Če ste pozabili vzeti Test Helicobacter INFAI za otroke v starosti 3 – 11 let Navedba smiselno ni potrebna.
No side effects are known.
Niso znani.
HOW TO STORE HELICOBACTER TEST INFAI FOR CHILDREN OF THE AGE 3-11
SHRANJEVANJE TESTA HELICOBACTER INFAI ZA OTROKE V STAROSTI 3 – 11 LET
These measures will help to protect the environment.
Zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na ovojnini.
What Helicobacter Test INFAI for children of the age 3-11contains
Kaj vsebuje zdravilo Test Helicobacter INFAI
One jar contains 45 mg 13C-urea.
- En kozarec vsebuje 45 mg 13C- uree
What Helicobacter Test INFAI for children of the age 3-11 looks like and contents of the pack Helicobacter Test INFAI for children of the age 3-11 years is a clear, colourless powder for oral solution.
Vsebina testnega kompleta za nedisperzivno infrardečo spektrometrijo
Content of the Test Kit:
Test vsebuje 1 kozarec z dodatnimi komponentami:
Component
element kocarek (prostornina 10 ml, polistiren s polietilenskim pokrovčkom), ki vsebuje 45 mg 13C- sečnine v obliki praška za peroralno raztopino
Quantity
Količina 1
containing 45 mg 13C-urea powder for oral solution Labelled sample glass- or plastic containers for sampling, storing and transporting the breath samples for analysis:
označena steklena ali plastična vsebnika za zbiranje, shranjevanje in prenašanje vzorcev za analizo
1
epruveti:
1
61
Marketing Authorisation Holder and Manufacturer INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Germany
Imetnik dovoljenja za promet in proizvajalec INFAI, Institut für Biomedizinische Analytik & NMR- Imaging GmbH, Universitätsstraße 142, D- 44799 Bochum, Nemčija.
60 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
62 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
España INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel: +49 234 971130
63 España INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Tel: +49 234 971130
61 France INFAI France SARL Eurocentre Tertiaire 50, avenue d’Alsace F- 68027 Colmar Tél: +33 389 204382
France INFAI France SARL Eurocentre Tertiaire 50, avenue d’ Alsace F - 68027 Colmar Tél: +33 389 204382 Ireland TECHNOPHARM Ltd.
This leaflet was last approved in MM/YYYY. -------------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
62 The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
Analiza razmerja med 13C in 12C v izdihanem ogljikovem dioksidu je sestavni del diagnostičnega postopka Testa Helicobacter INFAI za otroke v starosti 3 – 11 let.
Minimum of 3 replicate analyses on the same sample during operation
Zavarovan dostop:
Storing of operating parameters and of results under security access to avoid later manipulation 13
65 varovanim dostopom, da se prepreči poznejše spreminjanje podatkov.
C/12C-ratio with respect to Pee Dee Beliminate (PDB)
Razmerje med 13C in 12C glede na standard PDB (Pee Dee Nastavitev:
Sample loop:
Belemnite) Zanka za vzorec:
< 200 µl
< 200 µl so linearnost, stabilnost (natančnost referenčnega plina) in
All mass spectrometers for breath analysis must comply with the following specifications:
natančnost meritev. Vsi masni spektrometri za analizo izdihanega zraka morajo ustrezati naslednjim specifikacijam:
≤ 0.3 ‰ for 13C at natural abundance using a 10ml breath sample tube with 3% CO2 breath concentration
1% in 7% CO2 ≤ 0, 2 ‰ pri 10 zaporednih pulzih Stabilnost: ≤ 0, 3 ‰ pri običajni naravni prisotnosti 13C, z uporabo 10 ml Natančnost meritev: epruvete s 3% CO2 v izdihanem zraku
64 MINIMUM PARTICULARS TO APPEAR ON
66 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Helixate NexGen is a powder and solvent that are mixed together to make a solution for injection.
Zdravilo Helixate NexGen sestavljata prašek in vehikel, ki se zmešata v raztopino za injiciranje.
Helixate NexGen contains the active substance octocog alfa (recombinant coagulation factor VIII).
Helixate NexGen vsebuje zdravilno učinkovino oktokog alfa (rekombinantni koagulacijski faktor VIII).
Helixate NexGen is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Zdravilo Helixate NexGen se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno motnjo strjevanja krvi zaradi pomanjkanja faktorja VIII).
Helixate NexGen is intended for either short-term or long-term use.
Helixate NexGen je namenjen bodisi za kratkotrajno ali dolgotrajno uporabo.
Helixate NexGen is given by intravenous injection (into a vein) over several minutes, up to a rate of 2 ml per minute.
Helixate NexGen se daje z intravensko injekcijo (v veno) v trajanju več minut s hitrostjo največ 2 ml na minuto.
The dose and frequency depend on whether Helixate NexGen is used to treat haemorrhage (bleeding) or prevent it during surgery.
Odmerek in pogostost odmerjanja zdravila sta odvisna od tega, ali se Helixate NexGen uporablja za zdravljenje krvavitev ali za preprečevanje krvavitev med kirurškim posegom.
The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Odmerek je potrebno prilagoditi tudi glede na stopnjo resnosti krvavitve ali vrsto kirurškega posega.
Helixate NexGen can also be given as a continuous infusion (drip into a vein) for at least seven days in patients undergoing major surgery.
Helixate NexGen se lahko daje tudi s kontinuirano infuzijo (kapalno infuzijo v veno) v trajanju najmanj sedem dni pri bolnikih, pri katerih je bil opravljen večji kirurški poseg.
Full details on how to calculate the doses are included in the Package Leaflet.
Podrobni podatki o tem, kako izračunati ustrezni odmerek, so na voljo v Navodilu za uporabo.
The active substance in Helixate NexGen, octocog alfa, is a blood coagulation factor protein.
Zdravilna učinkovina v zdravilu Helixate NexGen, oktokog alfa, je beljakovinski krvni koagulacijski faktor.
In the body, factor VIII is one of the substances (factors) involved in blood coagulation (clotting).
Faktor VIII je ena izmed snovi (faktorjev) v telesu, ki sodelujejo pri (koagulaciji) strjevanju krvi.
Patients with haemophilia A lack factor VIII, and this causes blood coagulation problems, such as bleeding in the joints, muscles or internal organs.
Bolniki s hemofilijo A imajo pomanjkanje faktorja VIII, kar povzroča zaplete s strjevanjem krvi, kot je krvavenje v sklepe, mišice ali notranje organe.
Helixate NexGen is used to replace the missing factor VIII.
Z zdravilom Helixate NexGen se nadomesti manjkajoči faktor VIII.
It corrects the factor VIII deficiency and gives temporary control of the bleeding disorder.
To popravi pomanjkanje faktorja VIII ter vzpostavi začasni nadzor nad krvavitvami.
Octocog alfa is not extracted from human plasma but produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
Oktokog alfa se ne pridobiva iz človeške plazme, temveč se proizvaja z metodo, znano pod imenom „ tehnologija rekombinantne DNA “: proizvede ga celica, ki je prejela gen (DNA), s pomočjo katerega postane sposobna tvoriti človeški koagulacijski faktor VIII.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu. http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged NexGen given as an intravenous injection has been studied in 66 patients who had been previously treated with recombinant coagulation factor VIII and 61 children who had not.
Zdravilo Helixate NexGen je podobno zdravilu KOGENATE, vendar je za razliko od slednjega pridobljeno na drugačen način, in sicer tako, da v njem ni nobenih beljakovin človeškega izvora.
The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Zdravilo Helixate NexGen, vbrizgano z intravensko injekcijo, so preučili pri 66 bolnikih, ki so bili predhodno zdravljeni z rekombinantnim koagulacijskim faktorjem VIII, in pri 61 otrocih, ki z njim predhodno niso bili zdravljeni.
Helixate NexGen has also been studied as a continuous infusion in 15 patients with haemophilia A undergoing major surgery.
Zdravilo Helixate NexGen so preučili tudi ob dajanju tega zdravila v obliki kontinuirane infuzije pri 15 bolnikih s hemofilijo A, pri katerih je bil opravljen večji kirurški poseg.
The main measure of effectiveness was the doctor’ s assessment of how well bleeding was stopped.
Glavno merilo učinkovitosti je bila zdravnikova ocena uspešnosti zaustavitve krvavitve.
What benefit has Helixate NexGen shown during the studies?
Kakšne koristi je zdravilo Helixate NexGen izkazalo med raziskavami?
In the previously treated patients, overall, 95% of bleeds responded to one or two intravenous injections of Helixate NexGen.
V celoti je pri predhodno zdravljenih bolnikih v 95% primerov krvavitev prišlo do odziva na eno do dve intravenski injekciji zdravila Helixate NexGen.
In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two intravenous injections.
Pri predhodno nezdravljenih bolnikih je do odziva na terapijo z eno ali dvema intravenskima injekcijama prišlo v približno 90% epizod krvavitve.
When given as a continuous infusion, stopping bleeding was assessed as ‘ excellent ’ in all 15 patients.
Pri dajanju zdravila v obliki kontinuirane infuzije je bila zaustavitev krvavitve ocenjena kot „ odlična “ pri vseh 15 bolnikih.
Haemophilia A patients may develop antibodies (inhibitors) to factor VIII.
Pri bolnikih s hemofilijo A se lahko razvijejo protitelesa (zaviralci) faktorja VIII.
In clinical trials with Helixate NexGen, this happened in 14% of previously untreated patients and in 17% of children who had been treated for less than five days in the past.
V kliničnih preizkušanjih zdravila Helixate NexGen je do tega prišlo pri 14% predhodno nezdravljenih bolnikov in pri 17% otrok, ki so bili v preteklosti zdravljeni manj kot pet dni.
However, it is seen in less than 0.2% of patients treated for more than 100 days.
Vendar pa do tega pojava pride le pri 0, 2% bolnikov, zdravljenih več kot 100 dni.
If antibodies develop, Helixate NexGen will not work effectively.
Če pride do razvoja protiteles, zdravilo Helixate NexGen v takih primerih ni več učinkovito.
Hypersensitivity (allergic reactions) has sometimes been seen in patients treated with factor VIII-containing products.
Občasno so pri bolnikih, zdravljenih z zdravili, ki vsebujejo faktor VIII, zabeležili preobčutljivostne (alergične) reakcije.
Other side effects seen in rare cases were dysgeusia (taste disturbances), nausea, reactions at the injection site, pyrexia (fever), allergic or anaphylactic (severe allergic) reactions, abnormal blood pressure, dizziness, pruritus (itching) and rash.
Ostali neželeni učinki, kot so disgevzija (motnje okušanja), slabost, reakcije na mestu injiciranja, pireksija (povišana telesna temperatura) alergične ali anafilaktične (hude alergične) reakcije, nenormalni krvni tlak, omotica, pruritus (srbenje) in izpuščaji, so bili opaženi v redkih primerih.
Helixate NexGen should not be used in people who may be hypersensitive (allergic) to recombinant coagulation factor VIII, to mouse or hamster protein or to any of the other ingredients.
Zdravila Helixate NexGen ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) človeški koagulacijski faktor VIII, na beljakovine miši ali hrčka ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Helixate NexGen’ s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Helixate NexGen pri zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII) večje od z njim povezanih tveganj.
The Committee recommended that Helixate NexGen be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Helixate NexGen odobri dovoljenje za promet z zdravilom.
The European Commission granted a marketing authorisation valid throughout the European Union for Helixate NexGen on 4 August 2000.
Evropska komisija je dovoljenje za promet z zdravilom Helixate NexGen, veljavno po vsej Evropski uniji, odobrila dne 4. avgusta 2000.
The marketing authorisation was renewed on 4 August 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 4. avgusta 2005.
The marketing authorisation holder is Bayer HealthCare AG.
Imetnik dovoljenja za promet z zdravilom je družba Bayer HealthCare AG.
The full EPAR for Helixate NexGen is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Helixate NexGen je na voljo tukaj.
Invented name Strength
jakost
250 IU; solvent:
250 IU; vehikel:
1 vial + 1 vial + 1 set of administration devices*
1 viala + 1 viala + 1 pribor za dajanje zdravila *
500 IU; solvent:
500 IU; vehikel:
1000 IU; solvent:
1000 IU; vehikel:
2000 IU; solvent:
2000 IU; vehikel:
1 1 1
1 viala + 1 viala + 1 pribor za dajanje zdravila *
* - 1 filter transfer device 20/ 20
* - 1 pribor za prenos filtra 20/ 20
- 1 venipuncture set
- 1 pribor za vensko punkcijo
- 1 disposable 5 ml syringe
- 1 odmetno 5 ml brizgo
- 2 sterile alcohol swabs for single use
- 2 sterilna tampona z alkoholom za enkratno uporabo
Helixate NexGen 250 IU Powder and solvent for solution for injection.
Helixate NexGen 250 i. e. prašek in vehikel za raztopino za injiciranje
Recombinant Coagulation factor VIII, 250 IU/ vial.
Rekombinantni koagulacijski faktor VIII, 250 i. e. / vialo.
Recombinant Coagulation factor VIII is produced from genetically engineered baby hamster kidney cells containing the human factor VIII gene.
Rekombinantni koagulacijski faktor VIII izdelujejo iz genetsko spremenjenih ledvičnih celic mladičev hrčkov, ki vsebujejo gen za humani faktor VIII.
The product reconstituted with the accompanying 2.5 ml of water for injections contains approximately 100 IU octocog alfa/ ml.
Zdravilo po rekonstituciji s 2, 5 ml vode za injekcije vsebuje približno 100 i. e. oktokoga alfa/ ml.
The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in IU.
Aktivnost zdravila (i. e.) se ugotavlja z enostopenjskim preizkusom strjevanja krvi, v primerjavi z FDA mega- standardom, ki je bil umerjen glede na WHO standard v i. e.
The specific activity is approximately 4000 IU/ mg protein.
Specifična aktivnost je približno 4000 i. e. / mg proteina.
The powder is provided in a vial as a dry white to slightly yellow powder or cake.
Prašek v viali je suh bel do rahlo rumen prašek ali pogača.
The solvent is water for injections provided in a vial.
Vehikel je voda za injekcije in je priložena v viali.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII)
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
Posology 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.
Odmerjanje Količine faktorja VIII, potrebne za zdravljenje, so izražene v internacionalnih enotah (i. e.), ki so določene z WHO standardom za faktor VIII.
Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma).
Aktivnost faktorja VIII v plazmi je izražena v odstotkih (glede na normalno človeško plazmo) ali v internacionalnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Ena internacionalna enota (i. e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru normalne človeške plazme.