natgillin/translations-raw huggingface dataset:
The speed of administration should be based on your comfort, but should not be faster than 2 mL per minute. 
Hitrost injiciranja naj bo prilagojena vašemu počutju, vendar ne injicirajte hitreje kot 2 ml na minuto.
The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case. 
Velikost odmerka in pogostnost odmerjanja naj bosta določena glede na klinično učinkovitost pri posameznem bolniku.
• hypersensitivity reactions including severe sudden allergic reaction (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or anaphylactic shock, e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) 
• preobčutljivostne reakcije, tudi hude nenadne alergijske reakcije (ki lahko vključujejo izpuščaj, navzeo, koprivnico, angioedem, mrzlico, pordelost, glavobol, letargijo, zasoplost ali težave pri dihanju, nemir, tahikardijo, ščemenje ali anafilaktični šok, npr. tiščanje v prsnem košu/splošno slabo počutje, omotica in občutek siljenja na bruhanje in blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, ko vstanete)
KOGENATE Bayer can be infused by continuous infusion. 
Zdravilo KOGENATE Bayer se lahko uporabi kot kontinuirana infuzija.
This is similar to that of plasmaderived factor VIII which has a mean terminal half-life of approx. 13 hours. 
To je podobno kot pri faktorju VIII, pridobljenem iz plazme, kjer je povprečni razpolovni čas približno 13 ur.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
No case of overdose with recombinant coagulation factor VIII has been reported. 
Ni poročil o prevelikem odmerjanju rekombinantnega koagulacijskega faktorja VIII.
The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 mL/min). 
Hitrost injiciranja naj bo prilagojena bolnikovemu počutju (največja dovoljena hitrost injiciranja: 2 ml/min).
You may be at risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted. 
Obstaja lahko tveganje za zaplete, povezane s CVK, kot so lokalne okužbe, prisotnost bakterij v krvi (bakteriemija) in nastanek krvnih strdkov v krvnih žilah (tromboza) na mestu vstavitve katetra.
Gently rotate the vial until all powder is dissolved. 
Previdno obračajte vialo, dokler se ves prašek ne raztopi.
Furthermore, the PRAC examined clinical trials and the scientific literature for de novo inhibitors in PTPs. 
Poleg tega je odbor PRAC pregledal klinična preskušanja in strokovno literaturo glede zaviralcev de novo pri predhodno zdravljenih bolnikih.
In 2013, PRAC had concluded that the RODIN/Pednet findings were not sufficiently robust to support a conclusion that Kogenate FS/Helixate NexGen was associated with an increased risk of developing factor VIII inhibitors compared with other products. 
Leta 2013 je odbor PRAC ugotovil, da ugotovitve študije RODIN/Pednet niso bile dovolj robustne, da bi podprle sklep, da sta zdravili Kogenate FS/Helixate NexGen povezani z večjim tveganjem za pojav zaviralcev faktorja VIII v primerjavi z drugimi zdravili.
After reconstitution, the product must be used within 3 hours. 
Po rekonstituciji je treba zdravilo uporabiti v 3 urah.
• Inhibitor development is an identified risk with both pdFVIII and rFVIII products. 
• pojav zaviralcev je dokazano tveganje pri zdravilih s pdFVIII in rFVIII.
• you require a central venous access device (CVAD) for the administration of KOGENATE Bayer. 
• je pri vas za vnos zdravila KOGENATE Bayer potreben centralni venski kateter (CVK).
In 2016, PRAC had considered the findings of meta-analysis of all three studies (RODIN/Pednet, UKHCDO and FranceCoag studies), and again concluded that the currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhibitors, compared with other recombinant factor VIII products in PUPs. 
Leta 2016 je odbor PRAC upošteval ugotovitve metaanalize vseh treh študij (študije RODIN/Pednet, UKHCDO in FranceCoag) in ponovno ugotovil, da trenutno razpoložljivi dokazi ne potrjujejo, da je zdravilo Kogenate Bayer/Helixate NexGen povezano z večjim tveganjem za pojav zaviralcev faktorja VIII v primerjavi z drugimi zdravili z rekombinantnim faktorjem VIII pri predhodno nezdravljenih bolnikih.
The doctor should always adjust the dose and the frequency of administration according to your individual needs. 
Zdravnik mora odmerek in pogostost dajanja odmerka tega zdravila prilagoditi glede na vaše individualne potrebe.
KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials. 
Zdravilo KOGENATE Bayer kot pomožno snov vsebuje majhno količino polisorbata 80, za katerega je znano, da poveča hitrost ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materialov.
If the inhibitor is present at levels less than 10 Bethesda Units (BU) per mL, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer. 
Če je raven zaviralca manjša kot 10 Bethesda enot (BE) na mililiter, ga je možno nevtralizirati z dodatnim rekombinantnim koagulacijskim faktorjem VIII in nadaljevati klinično učinkovito zdravljenje z zdravilom KOGENATE Bayer.
• The section 4.4 of the SmPC should be amended to include a warning on the clinical importance of monitoring patients for FVIII inhibitor development (in particular warning on the clinical consequences of low compared to high titre inhibitors). 
• poglavje 4.4 povzetka glavnih značilnosti zdravila je treba spremeniti tako, da se vključi opozorilo o kliničnem pomenu spremljanja bolnikov za pojav zaviralcev FVIII (zlasti opozorilo o različnih kliničnih posledicah nizkega in visokega titra zaviralcev);
What you need to know before you use KOGENATE Bayer 
Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer
In view of the above, the PRAC recommended the following updates of sections 4.4, 4.8 and 5.1 of the SmPC as well as sections 2 and 4 of the Package Leaflet for the FVIII products indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) as follows: 
Glede na navedeno je odbor PRAC priporočil naslednje spremembe poglavij 4.4, 4.8 in 5.1 povzetka glavnih značilnosti zdravila ter poglavij 2 in 4 navodila za uporabo za zdravila s FVIII, ki so indicirana za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII), kot sledi:
Elevation of FVIII levels following administration, in particular with existing cardiovascular risk factors, might put a patient into the same risk for vessel closure or myocardial infarction as for the non-haemophilic population. 
Povečanje ravni faktorja VIII po uporabi, zlasti pri tistih s prisotnimi srčnožilnimi dejavniki tveganja, predstavlja pri bolniku najmanj enako tveganje za zaporo žil ali miokardni infarkt kakor pri populaciji, ki nima hemofilije.
In this case, this medicine expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier. 
V tem primeru rok uporabnosti zdravila poteče ob koncu 12-mesečnega obdobja ali z datumom izteka roka uporabnosti navedenega na viali zdravila, odvisno kateri je prej.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - FOR BIO-SET SYSTEM 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - ZA SISTEM BIO-SET
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERRESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. 
Bolnike je treba poučiti o zgodnjih znakih preobčutljivosti, ki vključujejo koprivnico, navzeo, generalizirano urtikarijo, tiščanje v prsnem košu, zasoplost, hipotenzijo in anafilakso.
May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label. 
Zdravilo lahko shranjujete pri temperaturi do 25 °C do 12 mesecev, vendar samo do datuma izteka roka uporabnosti navedenega na nalepki.
KOGENATE Bayer is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body. 
Ni verjetno, da bi zdravilo KOGENATE Bayer vplivalo na plodnost bolnikov ali bolnic, saj je zdravilna učinkovina v telesu naravno prisotna.
Do not refrigerate after reconstitution. 
Po rekonstituciji raztopine ne shranjujte v hladilniku.
Fill the syringe by drawing the plunger out slowly and smoothly. 
Napolnite injekcijsko brizgo tako, da počasi in mirno izvlečete bat brizge.
It is recommended that every time that you use KOGENATE Bayer, the name and batch number of the product are documented. 
Priporočljivo je, da po vsaki uporabi zdravila KOGENATE Bayer zabeležite ime zdravila in številko serije.
If no further dose is required, remove the venipuncture set and syringe. 
Če dodaten odmerek ni potreben, odstranite pribor za vensko punkcijo in injekcijsko brizgo.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. 
Zdravljenje naj traja vsaj 1 dan, dokler se krvavitev (glede na bolečino) ne ustavi oz. se rana ne zaceli.
• The PRAC considered the totality of the data submitted with regards to the risk of inhibitor development for the classes of recombinant and plasma derived FVIII products, in previously untreated patients (PUPs). 
• odbor PRAC je upošteval celotne predložene podatke z vidika tveganja za pojav zaviralcev za razrede zdravil s FVIII, pridobljenih rekombinantno ali iz plazme, pri predhodno nezdravljenih bolnikih.
If you use more KOGENATE Bayer than you should No cases of overdose with recombinant coagulation factor VIII have been reported. 
Če ste uporabili večji odmerek zdravila KOGENATE Bayer, kot bi smeli Ni poročil o prevelikem odmerjanju rekombinantnega koagulacijskega faktorja VIII.
• The PRAC also considered that studies conducted to date suffer from a variety of methodological limitations and, on balance, there is no clear and consistent evidence to suggest differences in relative risks between FVIII product classes based on available data. 
• odbor PRAC je prav tako menil, da imajo dosedanje študije številne metodološke omejitve in da na podlagi razpoložljivih podatkov na splošno ni jasnih in doslednih dokazov, ki bi nakazovali razlike v relativnih tveganjih med razredi zdravil s FVIII.
If you are unsure about this, ask your doctor. 
Če glede navedenega niste prepričani, se posvetujte z zdravnikom.
However the PRAC is of the view that there are uncertainties with regards to the findings of the SIPPET study which preclude the conclusion that there is a higher risk of inhibitor development in PUPs treated with rFVIII products than pdFVIII products studied in this clinical trial, as detailed below: 
obstajajo negotovosti v zvezi z ugotovitvami študije SIPPET, ki preprečujejo zaključek, da obstaja večje tveganje za pojav zaviralcev pri predhodno zdravljenih bolnikih z rFVIII kot s pdFVIII v zdravilih, preučenih v tem kliničnem preskušanju, kot je podrobno opisano v nadaljevanju:
It is strongly recommended that every time that KOGENATE Bayer is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product. 
Priporočljivo je, da se po vsaki uporabi zdravila KOGENATE Bayer zabeležita ime zdravila in številka serije, da je mogoča sledljivost med bolnikom in serijo zdravila.
Do not shake vial. 
Ne stresajte viale.
The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose (see end of section 2). 
Druge sestavine zdravila so glicin, natrijev klorid, kalcijev klorid, histidin, polisorbat 80 in saharoza (glejte zadnji odstavek poglavja 2).
The study was not designed and powered to generate sufficient product-specific data and, therefore, to draw any conclusions on the risk of inhibitor development for individual products. 
Študija ni bila zasnovana in ni imela zadostne moči za zbiranje podatkov o posameznih zdravilih in posledično sklepanje o tveganju za pojav zaviralcev pri posameznih zdravilih.
Other medicines and KOGENATE Bayer 
Druga zdravila in zdravilo KOGENATE Bayer
EU/1/00/143/007 - KOGENATE Bayer 250 IU EU/1/00/143/008 - KOGENATE Bayer 500 IU EU/1/00/143/009 - KOGENATE Bayer 1000 IU EU/1/00/143/011 - KOGENATE Bayer 2000 IU EU/1/00/143/013 - KOGENATE Bayer 3000 IU 
EU/1/00/143/007 - KOGENATE Bayer 250 i.e. EU/1/00/143/008 - KOGENATE Bayer 500 i.e. EU/1/00/143/009 - KOGENATE Bayer 1000 i.e. EU/1/00/143/011 - KOGENATE Bayer 2000 i.e. EU/1/00/143/013 - KOGENATE Bayer 3000 i.e.
2 dry swabs 
2 suha tampona
Further to the recent publication on the SIPPET study, the MAHs were requested to assess the potential impact of the results of this study and other relevant safety data on inhibitor development in PUPs on the MA of their FVIII product including consideration on risk minimisation measures. 
Po nedavni objavi študije SIPPET so morali imetniki dovoljenja za promet z zdravilom oceniti morebitni učinek rezultatov študije in drugih pomembnih varnostnih podatkov o pojavu zaviralcev pri predhodno nezdravljenih bolnikih na dovoljenja za promet z njihovim zdravilom s FVIII in preučiti ukrepe za zmanjšanje tveganja.
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).
However, the study found evidence of an increased risk of inhibitors (all and high titre) for 2nd generation rFVIII octocog alfa (Kogenate FS/Helixate NexGen) compared with 3rd generation rFVIII octocog alfa (which was driven solely by data for Advate). 
Vendar pa so v študiji odkrili dokaz o povečanem tveganju za zaviralce (vsi titri in visoki titri) za rFVIII oktokog alfa 2. generacije (Kogenate FS/Helixate NexGen) v primerjavi z rFVIII oktokog alfa 3. generacije (ki so ga predstavljali izključno podatki zdravila Advate).
Ensure that the powder is completely dissolved before use. 
Preverite, da je pred uporabo ves prašek popolnoma raztopljen.
More extensive haemarthrosis, muscle bleed or haematoma 
obsežnejše krvavitve v sklepe, mišice ali hematomi
Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children. 
Otroci in mladostniki Navedena opozorila n previdnostni ukrepi veljajo za bolnike vseh starosti, odrasle in otroke.
EU/1/00/143/004 - KOGENATE Bayer 250 IU EU/1/00/143/005 - KOGENATE Bayer 500 IU EU/1/00/143/006 - KOGENATE Bayer 1000 IU EU/1/00/143/010 - KOGENATE Bayer 2000 IU EU/1/00/143/012 - KOGENATE Bayer 3000 IU 
EU/1/00/143/004 - KOGENATE Bayer 250 i.e. EU/1/00/143/005 - KOGENATE Bayer 500 i.e. EU/1/00/143/006 - KOGENATE Bayer 1000 i.e. EU/1/00/143/010 - KOGENATE Bayer 2000 i.e. EU/1/00/143/012 - KOGENATE Bayer 3000 i.e.
The PRAC considered that as a prospective randomised trial, the SIPPET study avoided many of the design limitations of the observational and registry-based studies undertaken so far to evaluate the risk of inhibitor development in PUPs. 
Odbor PRAC je menil, da študija SIPPET kot prospektivno randomizirano preskušanje nima številnih omejitev zasnove opazovalnih in registrskih študij, ki so bile izvedene do sedaj, da bi ocenile tveganje za pojav zaviralcev pri predhodno nezdravljenih bolnikih.
However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see sections 4.3 and 4.4). 
Kljub temu pa pri nekaterih bolnikih, ki so nagnjeni k alergijam, obstaja možnost alergijskih reakcij na sestavine zdravila, npr. na sledove beljakovin miši in hrčkov (glejte poglavji 4.3 in 4.4).
Common (may affect up to 1 in 10 users): 
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
• chest tightness/general feeling of being unwell 
• tiščanje v prsnem košu/splošno slabo počutje
• you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine. 
• imate občutek tiščanja v prsnem košu, vrtoglavico, omedlevico, občutek siljenja na bruhanje ali ste omotični ko vstanete, je možno, da imate redko, hudo nenadno alergijsko reakcijo na to zdravilo (t.i. anafilaktično reakcijo).
Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated. 
Izkušenj o uporabi zdravila KOGENATE Bayer med nosečnostjo in dojenjem ni, zato se ga med nosečnostjo in dojenjem sme uporabljati le, če je to jasno indicirano.
Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose 
Prašek glicin natrijev klorid kalcijev klorid histidin polisorbat 80 saharoza
It found that patients treated with rFVIII products had an 87% higher incidence of all inhibitors than those treated with pdFVIII (which contained VWF) (hazard ratio, 1.87; 95% CI, 1.17 to 2.96). 
Ugotovili so, da je pri bolnikih, zdravljenih z zdravili z rFVIII, za 87 % večja pojavnosti vseh zaviralcev kot pri bolnikih, zdravljenih s pdFVIII (ki je vseboval VWF) (razmerje ogroženosti 1,87; 95-odstotni IZ od 1,17 do 2,96).
Detailed instructions for reconstitution and administration of KOGENATE Bayer using vial with vial adapter: 
Podrobnejša navodila za rekonstitucijo in uporabo zdravila KOGENATE Bayer pri uporabi vial z adaptarjem za vialo
If you forget to use KOGENATE Bayer 
Če ste pozabili uporabiti zdravilo KOGENATE Bayer
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). 
Neželeni učinki, navedeni v spodnji preglednici, so razvrščeni po organskih sistemih po klasifikaciji MedDRA (uporabljen je prednostni izraz po klasifikaciji MedDRA).
No interactions of KOGENATE Bayer with other medicinal products have been reported. 
O medsebojnem delovanju zdravila KOGENATE Bayer z drugimi zdravili niso bile narejene.
Patients should be monitored for the development of factor VIII inhibitors. 
Pri bolnikih je treba spremljati ali je prišlo do nastanka zaviralcev faktorja VIII.
• Finally, the PRAC noted that to date most studies evaluating a differential risk of inhibitor development between classes of FVIII products suffer from a variety of potential methodological limitations and based on the available data considered there is no clear and consistent evidence to suggest differences in relative risk between classes of FVIII products. 
• na koncu je odbor PRAC ugotovil, da ima večina do sedaj opravljenih študij, v katerih so vrednotili razlike v tveganju za pojav zaviralcev med razredi zdravil s FVIII, različne možne metodološke omejitve, zato je na podlagi razpoložljivih podatkov menil, da ni jasnih in doslednih dokazov, ki bi kazali na razlike v relativnem tveganju med razredi zdravil s FVIII.
The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution. 
Rekonstituirano zdravilo je treba pred uporabo filtrirati, da se odstrani morebitne delce v raztopini.
The new expiry date must be noted on the outer carton. 
Novi datum izteka roka uporabnosti zdravila mora biti naveden na zunanji ovojnini.
This medicine is intended for injection into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution. 
To zdravilo je namenjeno za injiciranje v veno, 2 do 5 minut, kar je odvisno od skupne količine raztopine in vašega počutja.
In Cox regression models for the primary end point of all inhibitors, rFVIII was associated with an 87% higher incidence than pdFVIII (hazard ratio, 1.87; 95% CI, 1.17 to 2.96). 
V Coxovih regresijskih modelih primarnega kazalnika izida je bil rFVIII povezan s 87 % večjo pojavnostjo kot pdFVIII (razmerje ogroženosti 1,87; 95-odstotni IZ od 1,17 do 2,96).
If this dose does not control your bleeding your doctor may consider giving you an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate. 
Če tudi večji odmerek ne bo zadostoval, se lahko zdravnik odloči za drugo zdravilo, koncentrat faktorja VIIa ali koncentrat (aktiviranega) protrombinskega kompleksa.
Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5 II. 
Potrebno število enot (i.e.) = telesna masa (kg) × želeni dvig faktorja VIII (% normalne vrednosti) × 0,5
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 znižane ravni faktorja VIII:C. Posledice so obsežne krvavitve v sklepe, mišice ali notranje organe.
Remove the stopper attached to the white cap from the syringe (A). 
Odstranite zamašek, ki je pritrjen na belo zaporko injekcijske brizge (A).
Filtering is achieved by using the vial adapter. 
Pri filtriranju je treba uporabiti adapter za vialo.
A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION 
IME ZDRAVILA IN, ČE JE POTREBNO, POT(I) UPORABE voda za injekcije
Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer. 
Podrobnejša navodila za pripravo in uporabo so v navodilu za uporabo, ki je priloženo zdravilu KOGENATE Bayer.
• The SIPPET analysis does not allow for product-specific conclusions to be made as it relates only to a small number of certain FVIII products. 
• analiza študije SIPPET ne omogoča sklepanja o specifičnih zdravilih, saj se nanaša samo na majhno število določenih zdravil s FVIII.
When blood must be withdrawn prior to an infusion, use an administration set without a filter, then infuse KOGENATE Bayer through an injection filter. 
Kadar je treba pred infundiranjem odvzeti kri, uporabite pribor brez filtra in nato infundirajte zdravilo KOGENATE Bayer skozi injekcijski filter.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. 
Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
Skin associated hypersensitivity reactions, (pruritus, urticaria and rash) 
Bolezni imunskega sistema preobčutljivos tne kožne reakcije (pruritus, urtikarija in osip)
Similar to RODIN/Pednet, the UKHCDO study found a significant increased risk of inhibitors (all and high titre) for Kogenate FS/Helixate NexGen (2nd generation rFVIII) compared to Advate (3rd generation rFVIII). 
V študiji UKHCDO so enako kot v študiji RODIN/Pednet ugotovili znatno povečanje tveganja za zaviralce (vsi titri in visoki titri) pri zdravilih Kogenate FS/Helixate NexGen (rFVIII 2. generacije) v primerjavi z zdravilom Advate (rFVIII 3. generacije).
Given these are heterogenous products, this does not preclude individual products being associated with an increased risk of inhibitor development in ongoing or future PUP studies. 
Glede na to, da so zdravila heterogena, ne moremo izključiti, da so s povečanim tveganjem za pojav zaviralcev v študijah pri predhodno nezdravljenih bolnikih v teku ali v prihodnosti povezana posamezna zdravila.
FVIII Inhibition (PTPs)* 
zaviranje faktorja VIII (PZB)*