natgillin/translations-raw huggingface dataset:
Efter rekonstituering indeholder dette lægemiddel 1, 23 mmol (29 mg) natrium pr. hætteglas, hvilket bør tages med i overvejelserne hos patienter på kontrolleret natriumdiæt.
After reconstitution this medicinal product contains 1.23 mmol (29 mg) sodium per vial, to be taken into consideration by patients on a controlled sodium diet.
Ingen dyrestudier under graviditet og amning er gennemført med faktor VIII.
Animal reproduction studies have not been conducted with factor VIII.
På grund af den sjældne forekomst af hæmofili A hos kvinder findes ingen erfaringer vedrørende brug af faktor VIII under graviditet og amning.
Because of the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast- feeding is not available.
Faktor VIII- hæmning
Factor VIII inhibition
Forekomsten af neutraliserende antistoffer (inhibitorer) mod faktor VIII er velkendt i behandlingen af hæmofili A- patienter.
The occurrence of neutralising antibodies (inhibitors) to factor VIII is well known in the treatment of patients with haemophilia A.
Ligesom med andre koagulationsfaktor VIII- produkter skal patienterne monitoreres med hensyn til udviklingen af inhibitorer, der skal titreres i Bethesda- enheder (BE) under anvendelse af Nijmegen- modifikationen af Bethesda- analysen.
As with all coagulation factor VIII products, patients are to be monitored for the development of inhibitors that are to be titrated in Bethesda Units (BUs) using the Nijmegen modification of the Bethesda assay.
Hvis sådanne inhibitorer forekommer, kan tilstanden komme til udtryk som et utilstrækkeligt klinisk respons.
If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
I disse tilfælde anbefales det at kontakte et center, der er specialiseret i behandling af hæmofili.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
I en klinisk undersøgelse med ReFacto AF hos tidligere behandlede patienter (PTP’ er) var incidensen af faktor VIII- inhibitorer det primære slutmål for sikkerhed.
In a clinical study with ReFacto AF in previously treated patients (PTPs), the incidence of factor VIII inhibitors was the primary safety endpoint.
Hos 94 patienter (2, 1%) blev der observeret to klinisk symptomløse, forbigående inhibitorer med lav titer med en median- eksponering på 76 eksponeringsdage (ED, interval 1- 92) svarende til 2, 2% af de 89 patienter med mindst 50 ED.
Two clinically silent, low-titre, transient inhibitors were observed in 94 patients with a median exposure of 76 exposure days (ED, range 1-92), corresponding to 2.2% of the 89 patients with at least 50 ED.
Median eksponering var på 58 ED (interval 5- 140), og 98 patienter havde mindst 50 ED for ReFacto AF.
In a supporting study of ReFacto AF, 1 de novo and 2 recurrent inhibitors (all low-titre, central laboratory determination) were observed in 110 patients; median exposure of 58 ED (range 5-140) and 98 patients had at least 50 ED to ReFacto AF.
98 af de oprindelige 110 patienter fortsatte behandlingen i en anden understøttende undersøgelse og havde efterfølgende en udvidet eksponering for ReFacto AF med en median på yderligere 169 ED (interval 9- 425).
Ninety-eight (98) of the original 110 patients continued treatment in a second supportive study and had subsequent extended exposure to ReFacto AF with a median of 169 additional ED (range 9-425).
Yderligere én de novo- inhibitor med lav titer blev observeret.
One (1) additional low-titre de novo inhibitor was observed.
Frekvensen af inhibitorer i disse studier er inden for det forventede område.
The frequency of inhibitors observed in these studies is within the expected range.
6 I en klinisk undersøgelse med ReFacto til PTP’ er blev der observeret én inhibitor hos 113 patienter.
In a clinical study with ReFacto in PTPs, 1 inhibitor was observed in 113 patients.
Der har også efter markedsføringen været spontane rapporter om inhibitorer med høje titre hos tidligere behandlede patienter.
Also, there have been spontaneous post-marketing reports of high-titre inhibitors involving previously treated patients.
Der er ingen kliniske data fra patienter, som ikke tidligere er behandlet (PUP’ er) med ReFacto AF.
6 There are no clinical data on previously untreated patients (PUPs) with ReFacto AF.
Der er dog planlagt kliniske undersøgelser med ReFacto AF med PUP’ er.
However, clinical trials are planned in previously untreated patients (PUPs) with ReFacto AF.
I en klinisk undersøgelse udviklede 32 ud af 101 (32%) tidligere ubehandlede patienter (PUP’ er), der blev behandlet med ReFacto, inhibitorer:
In a clinical trial, 32 out of 101 (32%) previously untreated patients (PUPs) treated with ReFacto developed inhibitors:
16 ud af 101 (16%) med en titer > 5 BU og 16 ud af 101 (16%) med en titer - ≤ 5 BU.
16 out of 101 (16%) with a titre > 5 BU and 16 out of 101 (16%) with a titre ≤ 5 BU.
Medianen for antallet af eksponeringsdage før udvikling af inhibitor var for disse patienter 12 (interval 3- 49).
The median number of exposure days up to inhibitor development in these patients was 12 (range 3-49).
Af de 16 patienter med høje titre fik 15 immuntolerancebehandling.
Of the 16 patients with high titres, 15 received immune tolerance (IT) treatment.
Af de 16 patienter med lave titre blev immuntolerancebehandling påbegyndt hos 10 patienter.
Of the 16 patients with low titres, IT treatment was started in 10.
Immuntolerancebehandling havde effekt hos 73% af patienterne med høje titre og hos 90% af dem med lave titre.
IT had an efficacy of 73% for patients with high titres and 90% for those with low titres.
For alle 101 PUP’ er, uanset udvikling af inhibitor, var medianen for antallet af eksponeringsdage 197 (interval 1 - 1299).
For all 101 treated PUPs, regardless of inhibitor development, the median number of exposure days is 197 (range 1-1299).
Andre bivirkninger baseret på erfaringer fra kliniske undersøgelser med ReFacto eller ReFacto AF er vist i nedenstående tabel pr. systemorganklasse og frekvens af forekomst pr. infusion.
Adverse reactions based on experience from clinical trials with ReFacto or ReFacto AF are presented in the table below by system organ class.
Meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 1/ 10); ikke almindelig (≥1/ 1. 000 til < 1/ 100).
These frequencies have been estimated on a per-patient basis and are described using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); and uncommon (≥ 1/ 1,000 to < 1/ 100).
7 Frekvens af forekomst pr. patient med ReFacto eller ReFacto AF
Frequency of Occurrence per Patient with ReFacto or ReFacto AF
almindelig (≥1/ 10)
(≥ 1/ 10)
(≥1/ 1. 000 til < 1/ 100)
(≥ 1/ 1,000 to < 1/ 100)
Blod og lymfesystem
Blood and lymphatic disorders Metabolism and nutrition disorders
Faktor VIII - inhibitorer – PUP’ er
Factor VIII inhibitors - PUPs
Faktor VIII- inhibitorer – PTP’ er
Factor VIII inhibitors - PTPs
Neuropati, svimmelhed, somnolens, dysgeusi
Nervous system disorders Cardiac disorders
Angina pectoris, takykardi, palpitationer
Neuropathy, dizziness, somnolence, dysgeusia Angina pectoris, tachycardia, palpitations
Hæmoragi/ hæmatom
Haemorrhage/ Haematoma
Hypotension, thrombophlebitis, vasodilatation, rødme
Hypotension, thrombophlebitis, vasodilatation, flushing
Mave- tarmkanalen Hud og subkutane væv
Gastrointestinal disorders
Abdominale smerter, diarré Urticaria, pruritus, udslæt, hyperhidrose
Abdominal pain, diarrhoea
Artralgi
Urticaria, pruritis, rash, hyperhidrosis
Myalgi
Musculoskeletal, connective tissue and bone disorders
Almene symptomer og reaktioner på administrationsstedet
Arthralgia
Asteni, pyreksi
Myalgia
Kuldegysninger, følelse af at fryse, inflammation på injektionsstedet, reaktion på injektionsstedet, smerte på injektionsstedet
General disorders and administration site conditions Investigations
Undersøgelser
Asthenia, pyrexia
Forhøjet aspartataminotransferase, forhøjet alaninaminotransferase, forhøjet blodbilirubin, forhøjet kreatinfosfokinase i blodet
Chills/ feeling cold, injection site inflammation, injection site reaction, injection site pain Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood creatine phosphokinase increased
Komplikation ved vaskulær adgang
Vascular access complication
Disse tilfælde var muligvis relateret til behandling med ReFacto AF.
One event of cyst in an 11-year old patient and one event described as confusion in a 13-year old patient have been reported as possibly related to ReFacto AF treatment.
Sikkerheden af ReFacto AF blev evalueret hos tidligere behandlede børn og unge (n=18, i alderen 12 - 16 år i én undersøgelse, og n=49, i alderen 7- 16 år i en understøttende undersøgelse).
7 Safety of ReFacto AF was evaluated in previously treated children and adolescents (n=18, age 12-16 in a study and n=49, age 7-16 in a supporting study).
Selv om det er et begrænset antal børn, der er undersøgt, er der en tendens til en højere frekvens af bivirkninger hos børn i alderen 7- 16 år sammenlignet med voksne.
Although a limited number of children have been studied, there is a tendency for higher frequencies of adverse events in children aged 7-16 as compared to adults.
Der er en klinisk undersøgelse i gang, hvor brugen af moroctocog alfa (AF- CC) til børn under 6 år evalueres.
A clinical trial evaluating use of moroctocog alfa (AF-CC) in children less than 6 years of age is on going.
Der blev også rapporteret om følgende bivirkninger for ReFacto: paræstesi, fatigatio, sløret syn, acne, gastritis, gastroenteritis og smerte.
The following adverse events have also been reported for ReFacto: paraesthesia, fatigue, blurred vision, acne, gastritis, gastroenteritis, and pain.
4. 4).
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently for ReFacto, and may in some cases progress to severe anaphylaxis including shock (see section 4.4).
8 Der kan forekomme spormængder af hamsterprotein i ReFacto AF.
Trace amounts of hamster protein may be present in ReFacto AF.
I meget sjældne tilfælde er der observeret udvikling af antistoffer mod hamsterprotein, men der var ingen kliniske følgevirkninger.
Very rarely, development of antibodies to hamster protein has been observed, but there were no clinical sequelae.
I en undersøgelse med ReFacto havde 20 ud af 113 (18%) tidligere behandlede patienter (PTP) en forøget anti- CHO- antistoftiter uden nogen tydelig klinisk effekt.
In a study of ReFacto, twenty of 113 (18%) PTPs had an increase in anti-CHO antibody titre, without any apparent clinical effect.
4. 4).
If any reaction takes place that is thought to be related to the administration of ReFacto AF, the rate of infusion is to be decreased or the infusion stopped, as dictated by the response of the patient (see section 4.4).
Farmakoterapeutisk gruppe: hæmostatika, blodkoagulationsfaktor VIII; ATC- kode:
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII; ATC code:
ReFacto AF indeholder rekombinant koagulationsfaktor VIII (moroctocog alfa) uden B- domæne.
ReFacto AF contains B-domain deleted recombinant coagulation factor VIII (moroctocog alfa).
170. 000 Da, som består af 1438 aminosyrer.
It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
Faktor VIII- aktiviteten er betydeligt nedsat hos patienter med hæmofili A, og substitutionsterapi er derfor nødvendig.
Factor VIII activity is greatly reduced in patients with haemophilia A, and, therefore, replacement therapy is necessary.
Når faktor VIII injiceres i en patient med hæmofili, går den i forbindelse med von Willebrand- faktoren i patientens kredsløb.
When infused into a haemophiliac patient, factor VIII binds to the von Willebrand factor present in the patient’ s circulation.
Aktiveret faktor VIII virker som en kofaktor for aktiveret faktor IX, hvorved omdannelsen af faktor X til aktiveret faktor X fremskyndes.
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X.
Hæmofili A er en kønsbestemt, arvelig blodkoagulationssygdom, der skyldes nedsat indhold af faktor VIII: C og medfører kraftig blødning i led, muskler eller indre organer, enten spontant eller som følge af traumer i forbindelse med ulykker eller operation.
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.
4. 2) hos 18 tidligere behandlede patienter, er anført i nedenstående tabel.
Pharmacokinetic properties of ReFacto, derived from a cross-over study of ReFacto and a plasma- derived FVIII concentrate, using the chromogenic substrate assay (see section 4.2), in 18 previously treated patients are listed in the table below.
9 Estimater for farmakokinetiske parametre for ReFacto hos tidligere behandlede patienter med hæmofili A
Pharmacokinetic parameter estimates for ReFacto in previously treated patients with haemophilia A PK parameter
AUCt (IE· time/ ml) t1/ 2 (time)
AUCt (IU· h/ ml)
19, 9 14, 8
19.9
4, 9 5, 6
4.9
19, 9 12, 7
19.9
CL (ml/ time· kg) MRT (time) K- værdi
t1/ 2 (h) CL (ml/ h· kg) MRT (h) K-value
2, 4 20, 2
14.8 2.4 20.2
0, 75 7, 4
5.6 0.75 7.4
2, 3 18, 0
12.7 2.3 18.0
IE/ kg indgivet FVIII)
(IU/ dl increase in FVIII: C per IU/ kg FVIII given)
AUCt = areal under plasmakoncentrations- tids- kurven fra nul til sidste målbare koncentration; t1/ 2 = halveringstid; CL = clearance; MRT = middel residenstid; K- værdi = tilvækst i gendannelse; SD = standardafvigelse
AUCt = area under the plasma concentration-time curve from zero to the last measurable concentration; t½ = half-life; CL = clearance; MRT = mean residence time; K-value = incremental recovery; SD = standard deviation
I en undersøgelse, hvor styrken af ReFacto AF, ReFacto og FVIII- aktiviteten i patientplasma blev målt under anvendelse af den kromogeniske substratanalyse, viste det sig, at ReFacto AF var bioækvivalent med ReFacto.
In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto.
Rationerne af middelværdierne fundet ved mindste kvadraters metode for ReFacto AF i forhold til ReFacto var 100, 6%, 99, 5% og 98, 1% for henholdsvis K- værdi, AUCt og AUC∞ (areal under plasmakoncentrations- tids- kurven fra tid nul til uendelig).
The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for K-value, AUCt and AUC∞ (area under the plasma concentration curve from time zero to infinity), respectively.
De tilsvarende 90% - konfidensintervaller for forholdet mellem de geometriske middelværdier for ReFacto AF og ReFacto lå inden for bioækvivalensintervallet på 80% til 125%, hvilket påviste bioækvivalens mellem ReFacto AF og ReFacto.
The corresponding 90% confidence intervals about the ratios of ReFacto AF to ReFacto geometric means were within the bioequivalence window of 80% to 125%, demonstrating bioequivalence of ReFacto AF to ReFacto.
I en farmakokinetisk overkrydsningsundersøgelse blev de farmakokinetiske parametre for ReFacto AF bestemt ved baseline og fulgt op hos 25 tidligere behandlede patienter (≥12 år) efter gentagen indgift af ReFacto AF i seks måneder.
In a cross-over pharmacokinetic study, the pharmacokinetic parameters for ReFacto AF were determined at baseline and followed-up in 25 previously treated patients (≥ 12 years) after repeated administration of ReFacto AF for six months.
Ratioerne for geometriske mindste kvadraters farmakokinetiske middelværdier ved måned 6 i forhold til baseline var 107%, 100% og 104% for henholdsvis K - værdi, AUCt og AUC∞.
The ratios of geometric least-square means of month 6-to-baseline pharmacokinetic were 107%, 100% and 104% for K-value, AUCt and AUC∞, respectively.
De tilsvarende 90% - konfidensintervaller omkring ratioerne for måned 6 i forhold til baseline for de ovennævnte farmakokinetiske parametre lå inden for ækvivalensintervallet på 80% til 125%.
The corresponding 90% confidence intervals about the ratios of month 6-to-baseline for the above pharmacokinetic parameters were within the equivalence window of 80% to 125%.
I samme undersøgelse, hvor lægemiddelstyrken for ReFacto AF og for et sammenligningspræparat med rekombinant faktor VIII i fuld længde (FLrFVIII) samt FVIII- aktiviteten målt i patientplasmaprøver blev bestemt under anvendelse af den samme éttrins- koagulationsanalyse på et centralt laboratorium, viste ReFacto AF sig under anvendelse af standard bioækvivalensmetoden at være farmakokinetisk ækvivalent med FLrFVIII hos 30 tidligere behandlede patienter (≥12 år).
In the same study, in which the drug potency of ReFacto AF and a full-length recombinant factor VIII (FLrFVIII) comparator, and the FVIII activity measured in patient plasma samples were all determined using the same one-stage clotting assay at a central laboratory, ReFacto AF was shown to be pharmacokinetically equivalent to FLrFVIII in 30 previously treated patients (≥ 12 years) using the standard bioequivalence approach.
Hos tidligere ubehandlede patienter (PUP’ er) blev de farmakokinetiske parametre for ReFacto evalueret under anvendelse af den kromogeniske analyse.
In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.
IE/ kg (interval 0, 2- 2, 8 IE/ dl pr.
These patients (n=59; median age 10 ± 8.3 months) had a mean incremental recovery at Week 0 of 1.5 ± 0.6 IU/ dl per IU/ kg (range 0.2 to 2.8 IU/ dl per IU/ kg) which was lower than that obtained in PTPs treated with ReFacto at Week 0 with a mean K-value of 2.4 ± 0.4 IU/ dl per IU/ kg (range 1.1 to 3.8 IU/ dl per IU/ kg).
IE/ kg).
In the PUPs, the mean incremental recovery was stable over time (5 visits during a 2-year period) and ranged from 1.5 to 1.8 IU/ dl per IU/ kg.
Farmakokinetisk populationsmodellering med data fra 44 tidligere ubehandlede patienter gav en gennemsnitlig, estimeret halveringstid på 8, 0 ± 2, 2 timer.
Population pharmacokinetic modeling using data from 44 PUPs led to a mean estimated half-life of 8.0 ± 2.2 hours.
Pulver Saccharose Kalciumkloriddihydrat L- histidin Polysorbat 80 Natriumklorid
Powder Sucrose Calcium chloride dihydrate L-Histidine Polysorbate 80 Sodium chloride
Solvens Natriumklorid Vand til injektion
Solvent Sodium chloride Water for injections
Uåbnet pulverhætteglas
Unopened powder vial
Der er påvist kemisk og fysisk stabilitet i brug i 3 timer ved temperaturer på op til 25 oC.
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25oC.
Produktet indeholder ikke konserveringsmiddel, og det rekonstituerede produkt skal anvendes straks eller inden for 3 timer efter rekonstituering.
The product does not contain a preservative, and the reconstituted product should be used immediately, or within 3 hours after reconstitution.
Må ikke nedfryses for at undgå at skade den fyldte injektionssprøjte.
Do not freeze, in order to prevent damage to the pre-filled syringe.
250 IE pulver i et 10 ml- hætteglas (type 1- glas) med en prop (butyl) og flip- off- forsegling (aluminium) og 4 ml solvens i en fyldt injektionssprøjte (type 1- glas) med en stempelprop (butyl), en kappe (butyl) og en steril hætteglasadapter til rekonstituering, et sterilt infusionssæt, alkoholkompresser, plaster og et kompres.
250 IU powder in a 10 ml vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 ml of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
11 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling
Det frysetørrede pulver til injektionsvæske skal rekonstitueres med den medfølgende solvens [0, 9% (9 mg/ ml) natriumkloridopløsning] fra den fyldte injektionssprøjte under anvendelse af den sterile hætteglasadapter til rekonstituering.
The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent [sodium chloride 9 mg/ ml (0.9%) solution] from the pre-filled syringe using the sterile vial adapter reconstitution device.
Produktet indeholder efter rekonstitution polysorbat- 80, som er kendt for at øge ekstraktionsraten af di - (2- ethylhexyl) phthalat (DEHP) fra polyvinylklorid (PVC).
The product, when reconstituted, contains polysorbate-80, which is known to increase the rate of di- (2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Dette skal der tænkes på i forbindelse med forberedelse og indgivelse af produktet, inklusive opbevaringstiden i en PVC- beholder efter rekonstitutionen.
This is to be considered during the preparation and administration of the product, including storage time elapsed in a PVC container following reconstitution.
6. 3 følges nøje.
It is important that the recommendations in section 6.3 be followed closely.
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Storbritannien
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom
13. april 1999 Dato for seneste fornyelse af tilladelsen:
13 April 1999 Date of last renewal:
ReFacto AF 500 IE pulver og solvens til injektionsvæske, opløsning.
ReFacto AF 500 IU powder and solvent for solution for injection.
Hvert hætteglas indeholder nominelt 500 IE * moroctocog alfa **.
Each vial contains nominally 500 IU* moroctocog alfa**.
125 IE moroctocog alfa.
After reconstitution, each ml of solution contains approximately 125 IU moroctocog alfa.
B- domænet fjernet), og med de samme post- translationelle modifikationer, der findes i molekyler udvundet fra plasma.
B-domain deleted) and similar post- translational modifications to those of the plasma-derived molecule.
Fremstillingsprocessen for ReFacto AF er blevet modificeret for at eliminere alle exogene, humant eller animalsk afledte proteiner i celledyrkningsprocessen, oprensningen og den endelige formulering, og samtidig er navnet ændret til ReFacto AF.
The manufacturing process for ReFacto has been modified to eliminate exogenous human- or animal- derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name has been changed to ReFacto AF.
Efter rekonstituering er der 1, 23 mmol (29 mg) natrium pr. hætteglas
After reconstitution, 1.23 mmol (29 mg) sodium per vial.
13 Dosering
Posology
Styrken af ReFacto AF i henhold til mærkningen er baseret på den Europæiske Farmakopés kromogeniske substratanalyse, ifølge hvilken standarden for fremstillingsstyrke er blevet kalibreret i forhold til WHO’ s internationale standard under anvendelse af den kromogeniske substratanalyse.
12 The labelled potency of ReFacto AF is based on the European Pharmacopoeial chromogenic substrate assay, in which the manufacturing potency standard has been calibrated to the WHO International Standard using the chromogenic substrate assay.
Hvis en patient, som normalt behandles med XYNTHA, får ordineret ReFacto AF, kan den behandlende læge overveje at justere dosisanbefalingerne baseret på faktor VIII - regenerationssværdierne.
If a patient normally treated with XYNTHA is prescribed ReFacto AF, the treating physician may consider adjustment of dosing recommendations based on factor VIII recovery values.
14 Blødningsgrad / Type kirurgisk indgreb
13 Degree of haemorrhage/ Type of surgical procedure
Patienter, der får faktor VIII- erstatningsbehandling, bør overvåges for udvikling af faktor VIII- inhibitorer.
Patients using factor VIII replacement therapy are to be monitored for the development of factor VIII inhibitors.