natgillin/translations-raw huggingface dataset:
Hvis De har taget for mange Advagraf- kapsler Hvis De ved en fejltagelse har taget for mange Advagraf- kapsler, skal De straks kontakte lægen eller den nærmeste skadestue.
If you take more Advagraf than you should If you have accidentally taken too much Advagraf see your doctor or contact your nearest hospital emergency department immediately.
Hvis De har glemt at tage Advagraf Hvis De har glemt at tage Deres Advagraf- kapsler om morgenen, skal De tage dem så hurtigt som muligt den samme dag.
If you forget to take Advagraf If you have forgotten to take your Advagraf capsules in the morning, take them as soon as possible on the same day.
Hvis De holder op med at tage Advagraf Afbrydelse af behandlingen med Advagraf kan øge risikoen for afstødning af det transplanterede organ.
If you stop taking Advagraf Stopping your treatment with Advagraf may increase the risk of rejection of your transplanted organ.
Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om eller følger Dem usikker på.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
63 4.
63 4.
Advagraf kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Advagraf can cause side effects, although not everybody gets them.
Immunhæmmende behandling, inklusiv Advagraf, nedsætter kroppens egen forsvarsmekanisme for at undgå, at det transplanterede organ afstødes.
Immunosuppressants, including Advagraf, reduce your body´s own defence mechanisms to stop you rejecting your transplanted organ.
Som følge heraf vil Deres krop ikke kunne bekæmpe infektioner så godt som normalt.
Consequently your body will not be as good as normal at fighting infections.
Hvis De får Advagraf, kan De derfor få flere infektioner end normalt, som for eksempel infektioner i huden, munden, maven og tarmen, lunger og urinvejen.
So if you are taking Advagraf you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
Der er set alvorlige bivirkninger inklusive allergiske og anafylaktiske reaktioner.
Severe effects may occur, including allergic and anaphylactic reactions.
Der er set godartede og ondartede svulster efter Advagraf- behandling som et resultat af immunhæmmende behandling.
Benign and malignant tumours have been reported following Advagraf treatment as a result of immunosuppression.
De mulige bivirkninger er opdelt i følgende kategorier:
Possible side effects are listed according to the following categories:
Meget almindelige bivirkninger forekommer hos mindst 1 ud af 10 patienter.
Very common side effects are experienced in at least 1 in 10 patients.
Almindelige bivirkninger forekommer hos mindre end 1 ud af 10 patienter, men hos mindst 1 ud af 100 patienter.
Common side effects are experienced in less than 1 in 10 patients but in at least 1 per 100 patients.
Ikke almindelige bivirkninger forekommer hos mindre end 1 ud af 100 patienter, men hos mindst 1 ud af 1000 patienter.
Uncommon side effects are experienced in less than 1 in 100 patients but in at least 1 per 1,000 patients.
Sjældne bivirkninger forekommer hos mindre end 1 ud af 10. 000 patienter, men hos mindst 1 ud af 10. 000 patienter.
Rare side effects are experienced in less than 1 per 1,000 patients but in at least 1 per 10,000 patients.
Meget sjældne bivirkninger forekommer hos færre end 1 ud af 10. 000 patienter.
Very rare side effects are experienced in less than 1 per 10,000 patients.
- Forhøjet blodsukker, sukkersyge, øget kaliumindhold i blodet
- Increased blood sugar, diabetes mellitus, increased potassium in the blood
- Søvnløshed
- Difficulty in sleeping
- Rysten, hovedpine
- Trembling, headache
- Forhøjet blodtryk,
- Increased blood pressure
- Diarré, kvalme
- Diarrhoea, nausea
- Nyreproblemer
- Kidney problems
- Nedsat antal blodceller (plader, røde eller hvide blodlegemer), stigning af hvide blodlegemer,
- Reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell
ændret antal røde blodlegemer
counts, changes in red blood cell counts
- Nedsat indhold af magnesium, fosfat, kalium, calcium eller natrium i blodet, væskeophobning,
- Reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
stigning af urinsyre eller fedt i blodet, nedsat appetit, forhøjet surhed af blodet, andre ændringer i blodet salte
increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts
- Ængstelse, forvirring og desorientering, depression, humørsvingninger, mareridt,
- Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare,
hallucinationer, forstyrret sindstilstand
hallucination, mental disorders
- Anfald, bevidsthedsforstyrrelser, prikken og følelsesløshed (nogle gange smertefuld) i hænder
- Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and
og fødder, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet
feet, dizziness, impaired writing ability, nervous system disorders
- Sløret syn, øget lysfølsomhed, problemer med øjnene
- Blurred vision, increased sensitivity to light, eye disorders
- Ringen for ørene
- Ringing sound in your ears
- Nedsat blodgennemstrømning i hjertets blodkar, øget puls
- Reduced blood flow in the heart vessels, faster heartbeat
- Blødning, delvis eller fuldstændig blokering af blodkar, nedsat blodtryk
- Bleeding, partial or complete blocking of blood vessels, reduced blood pressure
- Stakåndethed, forandring i lungevæv, væskeansamling omkring lungen, betændelse i svælget,
- Shortness in breath, changes in the lung tissue, collection of liquid around the lung,
hoste, influenzalignende symptomer
inflammation of the pharynx, cough, flu-like symptoms
- Betændelse eller mavesår som giver mavesmerter eller diarré, maveblødning, betændelse eller
- Inflammations or ulcers causing abdominal pain or diarrhoea, bleedings in the stomach,
sår i munden, væskeansamling i bughulen, opkastning, mavesmerter, fordøjelsesbesvær, forstoppelse, flatulens, oppustethed, løs afføring, maveproblemer
inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, flatulence, bloating, loose stools, stomach problems
- Ændringer i levertal og funktion, gulsot, ødelæggelse af levervæv og leverbetændelse
- Changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue
- Kløe, udslæt, hårtab, akne, svedudbrud
- Itching, rash, hair loss, acne, increased sweating
- Smerter i led, lemmer eller ryg, muskelkramper
- Pain in joints, limbs or back, muscle cramps
- Utilstrækkelig nyrefunktion, nedsat urindannelse, forringet eller smertefuld vandladning
- Insufficient function of the kidneys, reduced production of urine, impaired or painful urination
- General svaghed, feber, væskeansamling i kroppen, smerter og ubehag, øget indhold af basisk
- General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the
fosfatase i blodet, vægtstigning, ændret opfattelse af kropstemperatur
enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed
- Utilstrækkelig funktion af det transplanterede organ
- Changes in blood clotting, reduction in all blood cell counts
- Dehydrering, nedsat protein og sukker i blodet, øget fosfat i blodet
- Dehydration, reduced protein or sugar in the blood, increased phosphate in the blood
- Koma, blødning i hjernen, slagtilfælde, lammelse, forandringer i hjernen, tale - og
- Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language
sprogforstyrrelser, hukommelsesproblemer
abnormalities, memory problems
- Uklarhed af linsen
- Opacity of the lens
- Nedsat hørelse
- Impaired hearing
- Uregelmæssigt hjerteslag, hjertestop, hjertesvigt, forstyrrelser i hjertemuskulaturen, forstørret
- Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart
hjertemuskulatur, øget puls, unormalt EKG, unormalt hjerteslag og puls
muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal
- Blodprop i vene i lemmerne, shock
- Blood clot in a vein of a limb, shock
- Åndedrætsbesvær, lidelser i luftvejene, astma
- Difficulties in breathing, respiratory tract disorders, asthma
- Tarmslyng, øget blodnivau af enzymet amylase, tilbageløb af maveindhold, forsinket tømning
- Obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content
af mavesækken
in your throat, delayed emptying of the stomach
- Eksem, brændende fornemmelse i sollys
- Dermatitis, burning sensation in the sunlight
- Ledproblemer
- Joint disorders
- Ophørt urinproduktion, smertefuld menstruation og unormal menstruationsblødning
- Inability to urinate, painful menstruation and abnormal menstrual bleeding
- Organsvigt, influenzalignende sygdom, øget temperaturfølsomhed, trykken for brystet,
- Failure of some organs, influenza like illness, increased sensitivity to heat and cold, feeling of
nervøsitet eller fremmedfølelse, stigning i blodets indhold af enzymet laktatdehydrogenase, vægttab
pressure on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood, weight loss
- Små blødninger i huden
- Small bleedings in your skin due to blood clots
- Øget muskelstivhed
- Increased muscle stiffness
- Blindhed
- Blindness
- Døvhed
- Deafness
- Væskeansamling omkring hjertet
- Collection of fluid around the heart
- Akut åndenød
- Acute breathlessness
- Cystedannelse på bugspytkirtlen
- Cyst formation in your pancreas
- Problemer med blodcirkulation i leveren
- Problems with blood flow in the liver
- Alvorlig sygdom med blærer i huden, munden, øjnene og kønsorganerne, øget behåring
- Serious illness with blistering of skin, mouth, eyes and genitals; increased hairiness
- Tørst, øget tendens til at falde, trykken for brystet, nedsat bevægelighed, sår
- Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
- Muskelsvaghed
- Muscular weakness
- Unormalt ekkokardiogram
- Echocardiogram abnormal
- Leversvigt, forsnævring af galdevejene
- Liver failure, narrowing of the bile vessel
- Smertefuld vandladning med blod i urinen
- Painful urination with blood in the urine
- Øget fedtvæv
- Increase of fat tissue
OPBEVARING
HOW TO STORE ADVAGRAF
Tag depotkapslerne lige efter de er udtaget af blisteren.
Take the prolonged-release capsules immediately following removal from the blister.
Brug ikke Advagraf efter den udløbsdato, der står på pakningen efter EXP.
Do not use Advagraf after the expiry date which is stated on the carton after “ Exp”.
Brug alle depotkapslerne inden for 1 år efter at aluminiumposen er åbnet.
Use all the prolonged-release capsules within 1 year of opening the aluminium wrapping.
YDERLIGERE OPLYSNINGER
65 What Advagraf contains
Hver kapsel Advagraf 0, 5 mg indholder 0, 5 mg tacrolimus.
Each capsule of Advagraf 0.5 mg contains 0.5 mg of tacrolimus.
Hver kapsel Advagraf 1 mg indholder 1 mg tacrolimus.
Each capsule of Advagraf 1 mg contains 1 mg of tacrolimus.
Hver kapsel Advagraf 5 mg indholder 5 mg tacrolimus.
Each capsule of Advagraf 5 mg contains 5 mg of tacrolimus.
Hypromellose, ethylcellulose, laktosemonohydrat, magnesiumstearat.
Hypromellose, Ethylcellulose, Lactose, Magnesium stearate.
Titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), gelatine.
Titanium dioxide (E171), Yellow iron oxide (E 172), Red iron oxide (E 172), Gelatin.
Shellak, lecitin (soja), simeticon, rød jernoxid (E172), hydroxypropyl cellulose.
Shellac, Lecithin (soya), Simethicone, Red iron oxide (E 172), Hydroxypropyl Cellulose.
Advagraf 0, 5 mg depotkapsler med indhold af hvidt pulver er hårde gelatinekapsler præget med rødt ” 0. 5 mg ” på den lysegule kapsel top og ” * 647 ” på den orange kapselbund.
Advagraf 0.5 mg Prolonged-release capsules are hard gelatin capsules imprinted in red with “ 0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder.
Advagraf 0, 5 mg findes som blisterkort med 10 kapsler i en beskyttende foliepose med et tørremiddel.
Advagraf 0.5 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
De findes i pakker med 30, 50 og 100 depotkapsler.
Packs of 30, 50 and 100 prolonged-release capsules are available.
Advagraf 1 mg depotkapsler med indhold af hvidt pulver er hårde gelatinekapsler præget med rødt ” 1 mg ” på den hvide kapseltop og ” * 677 ” på den orange kapselbund.
Advagraf 1 mg Prolonged-release capsules are hard gelatin capsules imprinted in red with “ 1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder.
Advagraf 1 mg findes som blisterkort med 10 kapsler i en beskyttende foliepose med et tørremiddel.
Advagraf 1 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
De findes i pakker med 30, 50, 60 og 100 depotkapsler.
Packs of 30, 50, 60 and 100 prolonged-release capsules are available.
Advagraf 5 mg depotkapsler med indhold af hvidt pulver er hårde gelatinekapsler præget med rødt ” 5 mg ” på den grå- røde kapseltop og ” * 687 ” på den orange kapselbund.
Advagraf 5 mg Prolonged-release capsules are hard gelatin capsules imprinted in red with “ 5 mg” on the greyish red capsule cap and “ 687” on the orange capsule body, containing white powder.
Advagraf 5 mg findes som blisterkort med 10 kapsler i en beskyttende foliepose med et tørremiddel.
Advagraf 5 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant.
Hvis De vil have yderligere oplysninger om denne medicin, skal De henvende Dem til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
66 België/ Belgique/ Belgien Astellas Pharma B. V.
66 België/ Belgique/ Belgien Astellas Pharma B. V.
Eesti Astellas Pharma Europe B. V.
Eesti Astellas Pharma Europe B. V.
Österreich Astellas Pharma Ges. m. b. H.
Österreich Astellas Pharma Ges. m. b. H.
67 France Astellas Pharma S. A. S.
67 France Astellas Pharma S. A. S.
Denne indlægsseddel blev senest godkendt den < MM/ ÅÅÅÅ >.
This leaflet was last approved in {MM/ YYYY}.
Advate er pulver og solvens, som er blandet til en injektionsvæske, opløsning.
Advate is a powder and solvent that are mixed together to make a solution for injection.
Advate anvendes til behandling og forebyggelse af blødning hos patienter med hæmofili A (medfødte blødningsforstyrrelser forårsaget af faktor VIII- mangel).
Advate is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Behandling med Advate skal startes af en læge med erfaring i behandling af hæmofili.
Advate should be started by a doctor who has experience in the treatment of haemophilia.
Advate indgives som injektion i en vene med en hastighed på op til 10 ml i minuttet.
Advate is given by injection into a vein at a rate of up to 10 ml per minute.
Dosis og frekvens er afhængig af, hvorvidt Advate anvendes til behandling af hæmorragi (blødning) eller til forebyggelse af blødning under operationer.
The dose and frequency depend on whether Advate is used to treat haemorrhage (bleeding) or to prevent it during surgery.
Nærmere oplysninger om, hvordan doserne beregnes, fremgår af indlægssedlen.
Full details on how to calculate the doses are included in the Package Leaflet.
Det aktive stof i Advate, octocog alfa, er et blodkoagulationsfaktorprotein.
The active substance in Advate, octocog alfa, is a blood coagulation factor protein.
Faktor VIII er et af de stoffer (faktorer) i kroppen, som medvirker ved blodets koagulation (størkning).
In the body, factor VIII is one of the substances (factors) involved in blood coagulation (clotting).
Patienter med hæmofili A mangler faktor VIII, og dette medfører blodkoaguleringsproblemer såsom blødninger i led, muskler eller indre organer.
Patients with haemophilia A lack factor VIII, and this causes blood coagulation problems, such as bleeding in the joints, muscles or internal organs.
Advate anvendes til at erstatte den manglende faktor VIII, til at korrigere faktor VIII- manglen og til at opnå midlertidig kontrol med blødningsforstyrrelser.
Advate is used to replace the missing factor VIII.
Advate er ikke udvundet af humant plasma, men produceres via en metode, der er kendt som 'rekombinant DNA- teknologi':
It corrects the factor VIII deficiency and gives temporary control of the bleeding disorder.
Det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at producere human koagulationsfaktor VIII.
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.
Hvordan blev Advate undersøgt?
How has Advate been studied?
Advate ligner et andet lægemiddel, som er godkendt i Den Europæiske Union (EU), kaldet Recombinate, men det fremstilles på en anden måde, således at lægemidlet ikke indeholder humane eller animalske proteiner.
Advate is similar to another medicine approved in the European Union (EU) called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine.
Hovedundersøgelsen af Advate sammenlignede derfor Advate med 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The study went on to look at the number 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
I undersøgelsen vurderede man også antallet af blødningsepisoder og målte Advates evne til at stoppe blødning på en skala fra “ ingen ” til “ særdeles god ” hos 107 patienter, der alle fik Advate.
Reproduction is authorised provided the source is acknowledged. of bleeding episodes and rated Advate’ s effectiveness in stopping bleeding on a scale from ‘ none’ to ‘ excellent’ in 107 patients, all of whom received Advate.
I tre yderligere undersøgelser så man på anvendelsen af lægemidlet til forebyggelse af blødning og ved kirurgiske indgreb hos patienter med moderat svær til svær hæmofili A, herunder en undersøgelse af 53 børn under seks år.
Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of six years.
Hvilken fordel viser undersøgelserne, at der er ved Advate?
What benefit has Advate shown during the studies?
I hovedundersøgelsen blev virkningen af Advate til forebyggelse af blødning bedømt som ” særdeles god ” eller ” god ” i 86% af de 510 nye blødningsepisoder.
In the main study, the effectiveness of Advate in the prevention of bleeding was rated as ‘ excellent’ or ‘ good’ in 86% of the 510 new bleeding episodes.
Endvidere krævede 81% af disse blødningsepisoder kun en enkelt behandling med Advate.
In addition, 81% of these bleeding episodes required only a single treatment with Advate.
De yderligere undersøgelser bekræftede Advates virkning, også hos børn under seks år.
The additional studies confirmed Advate’ s effectiveness, including in children under six years of age.
Hvilken risiko er der forbundet med Advate?
What is the risk associated with Advate?
Patienter med hæmofili A kan udvikle antistoffer (hæmmere) over for faktor VIII.
Haemophilia A patients may develop antibodies (inhibitors) to factor VIII.
Et antistof er et protein, som dannes af kroppen som reaktion på ukendte stoffer som led i kroppens naturlige forsvarssystem.
An antibody is a protein produced by the body in reaction to unknown agents as part of the natural defence system of the body.
Hvis der dannes antistoffer, vil Advates virkning ikke være effektiv.
If antibodies develop, Advate will not work effectively.
De hyppigste bivirkninger ved Advate (som kunne observeres hos mellem 1 og 10 patienter ud af 100) er svimmelhed, hovedpine, pyrexi (feber) og tilstedeværelse af antistoffer over for faktor VIII.
The most common side effects with Advate (seen in between 1 to 10 patients in 100) are dizziness, headache, pyrexia (fever) and the presence of antibodies against factor VIII.
Der er indberettet overfølsomhedsreaktioner (allergiske reaktioner) hos patienter behandlet med lægemidler indeholdende faktor VIII.
Hypersensitivity (allergic reactions) has sometimes been seen in patients treated with factor VIII-containing products.
Den fuldstændige liste over indberettede bivirkninger ved Advate fremgår af indlægssedlen.
For the full list of all side effects reported with Advate, see the Package Leaflet.
Advate må ikke anvendes af personer, som kan være overfølsomme (allergiske) over for human koagulationsfaktor VIII, muse - eller hamsterproteiner eller andre af indholdsstofferne.
Advate should not be used in people who may be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Hvorfor blev Advate godkendt?
Why has Advate been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Advate er større end risiciene ved behandling og forebyggelse af blødning hos patienter med hæmofili A (medfødt faktor VIII- mangel).
The Committee for Medicinal Products for Human Use (CHMP) decided that Advate’ s benefits are greater than its risks for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Udvalget anbefalede udstedelse af markedsføringstilladelse for Advate.
The Committee recommended that Advate be given marketing authorisation.
Andre oplysninger om Advate:
Other information about Advate:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Advate til Baxter AG den 2. marts 2004.
The European Commission granted a marketing authorisation valid throughout the EU for Advate to Baxter AG on 2 March 2004.
Markedsføringstilladelsen blev fornyet den 2. marts 2009.
The marketing authorisation was renewed on 2 March 2009.
Den fuldstændige EPAR for Advate kan ses her.
The full EPAR for Advate is available here.
Dette sammendrag blev sidst ajourført i 03- 2009
This summary was last updated in 03-2009.
EU- nummer EU/ 1/ 03/ 271/ 001
EU/ 1/ 03/ 271/ 001
Særnavn Advate
Advate
Styrke 250 IE
250 IU
Lægemiddelform Pulver og solvens til injektionsvæske, opløsning
Powder and solvent for solution for injection
Emballage Pulver: hætteglas Solvens: hætteglas
powder: vial (glass); solvent: vial (glass)
Indhold Pulver:
powder:
250 IE Solvens:
250 IU; solvent:
5 ml (50 IE/ ml)
5 ml (50 IU/ ml)
Paknings- størrelse 1 hætteglas + 1 hætteglas + anordning til rekonstituering
1 vial + 1 vial + reconstitution device
Pulver: hætteglas Solvens: hætteglas
powder: vial (glass); solvent: vial (glass)
Pulver:
powder:
500 IE Solvens:
500 IU; solvent:
5 ml (100 IE/ ml)
5 ml (100 IU/ ml)
1 hætteglas + 1 hætteglas + anordning til rekonstituering
1 vial + 1 vial + reconstitution device
1000 IE Solvens:
1000 IU; solvent:
5 ml (200 IE/ ml)
5 ml (200 IU/ ml)
1500 IE Solvens:
1500 IU; solvent:
5 ml (300 IE/ ml)
5 ml (300 IU/ ml)
2000 IE Solvens:
2000 IU; solvent:
5 ml (400 IE/ ml)
5 ml (400 IU/ ml)
3000 IE Solvens:
3000 IU; solvent:
5 ml (600 IE/ ml)
5 ml (600 IU/ ml)
ADVATE 250 IE pulver og solvens til injektionsvæske, opløsning.
ADVATE 250 IU powder and solvent for solution for injection
Hvert hætteglas indeholder nominalt 250 IE * human koagulationsfaktor VIII (rDNA), octocog alfa **.
Each vial contains nominally 250 IU* human coagulation factor VIII (rDNA), octocog alfa**.
50 IE octocog alfa.
After reconstitution, each ml solution for injection contains approximately 50 IU octocog alfa. * The potency (International Units) is determined using the chromogenic assay against an in-house standard that is referenced to the WHO standard.
4. 000- 10. 000 IE/ mg protein. ** Human koagulationsfaktor VIII fremstillet med rekombinant DNA- teknologi i kinesiske hamster ovarie (CHO) - celler.
The specific activity is approximately 4,000- 10,000 IU/ mg protein. ** Human coagulation factor VIII produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.