natgillin/translations-raw huggingface dataset:
Hold the vial on end above the vial adapter and syringe (I). 
Vialo držite nad adapterjem za vialo in injekcijsko brizgo (I).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL [for reconstitution of strengths 250/500/1000 IU] 5 mL [for reconstitution of strengths 2000/3000 IU] 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2,5 ml [za rekonstitucijo jakosti 250/500/1000 i.e.] 5 ml [za rekonstitucijo jakosti 2000/3000 i.e.]
In a clinical study about the use of continuous infusion in surgeries, heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions. 
V klinični študiji o uporabi kontinuirane infuzije pri kirurških posegih so tako kot pri drugih dolgotrajnih intravenskih infuzijah za preprečitev tromboflebitisa na mestu infundiranja uporabili heparin.
After reconstitution the solution is clear. 
Po rekonstituciji je raztopina bistra.
• one pre-filled syringe with 2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 
• 1 napolnjeno injekcijsko brizgo z 2,5 ml (za 250 i.e., 500 i.e. in 1000 i.e) ali 5 ml (za 2000 i.e.
Do not use KOGENATE Bayer 
Ne uporabljajte zdravila KOGENATE Bayer
There was also evidence for an increased risk with Refacto AF (another 3rd generation rFVIII) vs Advate, but only for all inhibitor development. 
V študiji so odkrili tudi dokaze za povečano tveganje z zdravilom Refacto AF (drugo zdravilo z rFVIII 3. generacije) v primerjavi z zdravilom Advate, vendar le za vse titre zaviralcev.
Hold the pre-filled water for injections syringe upright, grasp the plunger rod as per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C). 
Napolnjeno injekcijsko brizgo z vodo za injekcije držite navpično, primite bat brizge, kot je narisano, in ga z močnim privijanjem v smeri urinega kazalca pritrdite v navojni zamašek (C).
Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog). 
Tudi pri uporabi odmerkov, ki so bili nekajkrat večji od priporočenega kliničnega odmerka (glede na telesno maso) pri različnih laboratorijskih živalih (miš, podgana, kunec in pes) niso opazili nobenih akutnih ali subakutnih toksičnih učinkov zdravila KOGENATE Bayer.
Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood. 
Zdravljenje krvavitve Zdravnik bo izračunal velikost in pogostost dajanja odmerka tega zdravila, ki ga potrebujete, da se pri vas doseže želena raven faktorja VIII v krvi.
Peel off the paper cover on the vial adapter plastic housing. 
Odstranite papirnat pokrov s plastičnega ohišja adapterja za vialo.
You must filter the reconstituted product before administration to remove any possible particles in the solution. 
Rekonstituirano zdravilo morate pred uporabo filtrirati, da odstranite morebitne delce v raztopini.
KOGENATE Bayer contains the active substance human recombinant coagulation factor VIII (octocog alfa). 
Zdravilo KOGENATE Bayer vsebuje zdravilno učinkovino humani rekombinantni koagulacijski faktor VIII (oktokog alfa).
KOGENATE Bayer can be used in children of all ages. 
Uporaba pri otrocih in mladostnikih Zdravilo KOGENATE Bayer se lahko uporablja pri otrocih vseh starosti.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG 51368 Leverkusen Nemčija
How to store KOGENATE Bayer Contents of the pack and other information 
Shranjevanje zdravila KOGENATE Bayer Vsebina pakiranja in dodatne informacije
The SIPPET study 
Študija SNIPPET
The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU). 
Jakost zdravila (i.e.) se določa z enostopenjskim testom strjevanja krvi, v primerjavi z FDA megastandardom, ki je bil umerjen v mednarodnih enotah (i.e.) glede na standard SZO.
The analysis demonstrated that the frequency of inhibitor development is much lower in PTPs compared to PUPs. 
Analiza je pokazala, da je pogostnost pojava zaviralcev veliko manjša pri predhodno zdravljenih kot pri predhodno nezdravljenih bolnikih.
INSTRUCTIONS ON USE Read package leaflet before use. 
NAVODILA ZA UPORABO Pred uporabo preberite priloženo navodilo.
The CANAL study2 found no evidence of a class difference, including pdFVIII products with considerable quantities of von Willebrand factor; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.7 (95% CI 0.4-1.1), and for high titre inhibitors (≥5 BU) was 0.8 (95% CI 0.4 
V študiji CANAL2 niso našli dokazov o razlikah med razredi, vključno z zdravili s pdFVIII z znatnimi količinami von Willebrandovega faktorja, tako da je bilo za „klinično pomembne“ ravni zaviralcev popravljeno razmerje tveganja 0,7 (95-odstotni IZ 0,4-1,1), za visoke titre zaviralcev (≥ 5 BU) pa 0,8 (95-odstotni IZ 0,4-1,3).
In conclusion, further to the initial assessment and the re-examination procedure, PRAC maintains its conclusion that the benefit-risk balance of the human plasma derived and recombinant coagulation Factor VIII containing medicinal products remains favourable subject to the agreed changes to the product information (section 4.4, 4.8 and 5.1 of the SmPC). 
Po začetnem ocenjevanju in postopku ponovnega pregleda odbor PRAC ohranja mnenje, da razmerje med koristmi in tveganjem pri zdravilih, ki vsebujejo faktor VIII, pridobljen iz človeške plazme ali rekombinantno, ostaja ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu (poglavje 4.4, 4.8 in 5.1 povzetka glavnih značilnosti zdravila).
In May 2016, an open-label, randomised controlled trial aimed at addressing the incidence of inhibitors between the two classes (pdFVIII vs. rFVIII products) was published in the New England Journal of Medicine1. 
Maja 2016 je bilo v reviji New England Journal of Medicine1 objavljeno neslepo, randomizirano nadzorovano preskušanje, namenjeno obravnavi pojavnosti zaviralcev pri zdravljenju z dvema razredoma zdravil (pdFVIII in rFVIII).
For calculation of mL/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/mL). 
Za izračun hitrosti infundiranja v ml/h se hitrost infundiranja i.e./h/kg pomnoži s kg telesne mase/koncentracija raztopine (i.e./ml).
Do not use the venipuncture set provided for drawing blood because it contains an in-line filter. 
Priloženega pribora za vensko punkcijo ne uporabite za odvzem krvi, ker že vsebuje filter.
Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity. 
Ne uporabite zdravila KOGENATE Bayer, če v raztopini opazite vidne delce ali je raztopina motna.
Systemic Hypersensitivit y reactions (including anaphylactic reaction, nausea, blood pressure abnormal and, dizziness) 
sistemske preobčutljivos tne reakcije (tudi anafilaktična reakcija, navzea, nenormalen krvni tlak in omotica)
• local reactions where you injected the medication (e.g. burning sensation, temporary redness) 
• lokalne reakcije na mestu injiciranja (npr. pekoča bolečina, prehodna rdečina)
Name and address of the manufacturer(s) of the biological active substance 
Ime in naslov izdelovalca biološke zdravilne učinkovine (učinkovin)
The RODIN/Pednet study3 also found no evidence of a class difference in inhibitor risk between all pdFVIII vs all rFVIII; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.96 (95% CI 0.62-1.49), and for high titre inhibitors (≥5 BU/ml) was 0.95 (95% CI 0.56-1.61). 
V študiji RODIN/Pednet3 prav tako niso našli razlik glede tveganja za zaviralce med vsemi zdravili s pdFVIII in vsemi zdravili z rFVIII, tako da je bilo za „klinično pomembne“ ravni zaviralcev popravljeno razmerje ogroženosti 0,96 (95-odstotni IZ 0,62-1,49), za visoke titre zaviralcev (≥ 5 BU/ml) pa 0,95 (95-odstotni IZ 0,56-1,61).
Filtering can be achieved by following the reconstitution and/or administration steps as described in the package leaflet provided with KOGENATE Bayer. 
Pri filtriranju je treba upoštevati postopek za rekonstitucijo in/ali uporabo, ki je opisan v navodilu za uporabo zdravila KOGENATE Bayer.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use, single dose administration only. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo.
Within its overall shelf life of 30 months the product when kept in its outer carton, may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months. 
V 30-mesečnem roku uporabnosti lahko zdravilo shranjujete v zunanji ovojnini pri sobni temperaturi (do 25 °C) največ 12 mesecev.
Nervous System Disorders 
Bolezni živčevja disgevzija
This product is for single use only. 
Zdravilo je samo za enkratno uporabo.
Within the expiry date indicated on the label, this medicine when kept in its outer carton may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months. 
Do navedenega datuma izteka roka uporabnosti, lahko zdravilo v zunanji ovojnini shranjujete pri sobni temperaturi (do 25 °C) največ 12 mesecev.
Inject the solvent into the vial containing the powder by slowly pushing the syringe plunger down (F). 
Vehikel vbrizgajte v vialo s praškom s počasnim potiskanjem bata navzdol (F).
By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. 
S tem se začasno zmanjša pomanjkanje faktorja VIII in se zmanjša nagnjenost h krvavitvam.
Puncture the vein and secure the venipuncture set with a plaster. 
Punktirajte veno in z obližem pritrdite pribor za vensko punkcijo.
Attach the syringe to the venipuncture set and ensure that no blood enters the syringe (J). 
Nastavite injekcijsko brizgo na pribor za vensko punkcijo in preverite, da v injekcijski brizgi ni krvi (J).
Besides, the PRAC noted that several FVIII products currently include in their product information reference to data from study results which do not allow a definite conclusion on the inhibitor risk for individual products. 
Poleg tega je odbor PRAC opozoril, da so trenutno pri več zdravilih s FVIII v informacijah o zdravilu navedeni rezultati študij, ki ne omogočajo dokončnega zaključka o tveganju za pojav zaviralcev pri posameznih zdravilih.
Hold the syringe upright and push the plunger until no air is left in the syringe. 
Injekcijsko brizgo držite pokončno in potiskajte bat brizge toliko časa, da v injekcijski brizgi ni več zraka.
With regards to sections 4.8 and 5.1, the PRAC noted that several FVIII products currently include reference to data from study results which do not allow a definite conclusion on the inhibitor risk for individual products. 
V zvezi s poglavjema 4.8 in 5.1 je odbor PRAC ugotovil, da več zdravil s FVIII trenutno vsebuje sklice na rezultate študij, ki ne omogočajo dokončnega zaključka o tveganju za pojav zaviralcev pri posameznih zdravilih.
In view of the above, the PRAC concluded that the benefit-risk balance of Factor VIII products indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency), remains favourable subject to the changes to the product information agreed (section 4.4, 4.8 and 5.1 of the SmPC). 
Glede na navedeno je odbor PRAC menil, da razmerje med koristjo in tveganjem zdravil s faktorjem VIII, indiciranih za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII), ostaja ugodno, če se spremenijo informacije o zdravilu (poglavja 4.4, 4.8 in 5.1 povzetka glavnih značilnosti zdravila).
For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). 
Pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), pa je tveganje občasno (pri manj kot 1 od 100 bolnikov).
• you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back. 
• je pri vas že kdaj prišlo do nastanka zaviralcev faktorja VIII, obstaja pri zamenjavi enega zdravila s faktorjem VIII z drugim zdravilom s faktorjem VIII, tveganje za ponovni nastanek zaviralcev.
The venipuncture set provided with the product must not be used for drawing blood because it contains an in-line filter. 
Pribora za vensko punkcijo, priloženega zdravilu, se ne sme uporabiti za odvzem krvi, ker že vključuje filter.
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 with recombinant factor VIII products and may in some cases progress to severe anaphylaxis (including shock). 
Pri zdravilih, ki vsebujejo rekombinantni faktor VIII, so poročali o preobčutljivosti ali alergijskih reakcijah (ki lahko vključujejo angioedem, skelenje in zbadanje na mestu infundiranja, mrzlico, pordelost, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, tiščanje v prsnem košu, ščemenje, bruhanje, zasoplost), ki lahko v nekaterih primerih napredujejo do hude anafilakse (tudi do šoka).
Holding the adapter housing, place over the product vial and firmly press down (B). 
Držite ohišje adapterja in ga poveznite čez vialo z zdravilom, nato pa močno pritisnite navzdol (B).
• one vial plus Bio-Set system, containing powder (10 mL clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper plus transfer system with protective cap [Bio-Set]) 
• 1 vialo s praškom in sistem Bio-Set (10-mililitrska viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in sistem za prenos vehikla z zaščitno zaporko [Bio-Set])
LIST OF EXCIPIENTS Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose. 
SEZNAM POMOŽNIH SNOVI Pomožne snovi: glicin, natrijev klorid, kalcijev klorid, histidin, polisorbat 80, saharoza.
Other possible side effects: 
Drugi možni neželeni učinki
Whether there are significant differences in the risk of inhibitor development between different types of FVIII replacement product remains an area of uncertainty. 
Ni še povsem jasno, ali obstajajo pomembne razlike v tveganju za pojav zaviralcev med različnimi vrstami zdravil za nadomeščanje FVIII.
Do not use solutions that contain visible particles or that are cloudy. 
Ne uporabljajte raztopine, ki vsebuje vidne delce ali je motna.
Invert vial/syringe and transfer the solution into syringe by drawing the plunger out slowly and smoothly (H). 
Obrnite vialo/ injekcijsko brizgo in prenesite raztopino v injekcijsko brizgo tako, da enakomerno in počasi izvlečete bat brizge (H).
For high-titre inhibitors, the hazard ratio was 1.69 (95% CI, 0.96 to 2.98). 
Za zaviralce z visokim titrom je bilo razmerje ogroženosti 1,69 (95-odstotni IZ od 0,96 do
Expected factor VIII rise (% of normal) = 2 × administered IU 
Pričakovani dvig faktorja VIII (% normalne vrednosti) = 2 × dani odmerek (i.e.) telesna masa (kg)
Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII. 
Podatke o indukciji imunske tolerance so zbrali pri bolnikih s hemofilijo A, pri katerih so nastali zaviralci faktorja VIII.
Based on the current evidence from the SIPPET study, as well as data from the individual clinical trials and observational studies included in the MAH responses, and the views expressed by the experts of the ad-hoc expert meeting, the PRAC agreed that the current evidence does not provide clear and consistent evidence of any statistically and clinically meaningful differences in inhibitor risk between rFVIII and pdFVIII products. 
Na podlagi dokazov iz študije SIPPET ter podatkov iz posameznih kliničnih preskušanj in opazovalnih študij, vključenih v odzive imetnikov dovoljenj za promet z zdravilom, ter stališč, ki so jih izrazili strokovnjaki ad-hoc strokovnega sestanka, se je odbor PRAC strinjal, da sedanji dokazi ne zagotavljajo jasnih in doslednih dokazov o statistično in klinično pomembnih razlikah glede tveganja za pojav zaviralcev med zdravili z rFVIII in pdFVIII.
• With regards to sections 4.8 and 5.1 of the SmPC, the PRAC noted that several FVIII products currently include reference to data from study results which do not allow for a definite conclusion on the inhibitor risk for individual products. 
• v zvezi s poglavjema 4.8 in 5.1 povzetka glavnih značilnosti zdravila je odbor PRAC ugotovil, da več zdravil s FVIII trenutno vsebuje sklice na rezultate študij, ki ne omogočajo dokončnega zaključka o tveganju za pojav zaviralcev pri posameznih zdravilih.
Do not use this medicine if you notice any particles or the solution is cloudy. 
Ne uporabljajte tega zdravila, če v raztopini opazite vidne delce ali je raztopina motna.
Hold a pad firmly over the injection site on your outstretched arm for approximately 2 minutes. 
Držite roko iztegnjeno in na mestu injiciranja še približno dve minuti pritiskajte blazinico.
No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer. 
Študije mutagenega poteciala zdravila KOGENATE Bayer niso bile narejene, ker pri predhodniku zdravila KOGENATE Bayer v in vitro in in vivo študijah niso opazili mutagenega delovanja.
Due to heterogeneity across products, there is considerable uncertainty in extrapolating the findings of studies that have evaluated only class effects to individual products; and particularly to products (including more recently authorised products) which are not included in such studies. 
Zaradi heterogenosti med zdravili obstaja precejšnja negotovost pri ekstrapoliranju ugotovitev študij, v katerih so obravnavali samo učinke razreda zdravil, zlasti na zdravila (vključno z nedavno odobrenimi zdravili), ki niso bila vključena v študije;
Each pack of KOGENATE Bayer contains a vial with Bio-Set transfer system and a pre-filled syringe with a separate plunger rod, as well as a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer vsebuje vialo s sistemom Bio-Set in napolnjeno injekcijsko brizgo z ločenim batom brizge, pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
• one vial with powder (10 mL clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal) 
• 1 vialo s praškom (10-mililitrska viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in z gumijasto zaporko)
MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG 51368 Leverkusen Nemčija
Each pack of KOGENATE Bayer contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters. 
Eno pakiranje zdravila KOGENATE Bayer vsebuje vialo in napolnjeno injekcijsko brizgo z ločenim batom brizge ter adapter za vialo, pribor za vensko punkcijo (za injiciranje v veno), dva alkoholna tampona, dva suha tampona in dva obliža.
Due to the heterogeneity across products, there is considerable uncertainty in extrapolating the findings of studies evaluating only class effects to individual products; and particularly to the products that are not included in such studies. 
Zaradi heterogenosti med zdravili obstaja precejšnja negotovost pri ekstrapoliranju ugotovitev študij, v katerih so obravnavali samo učinke razreda zdravil, zlasti na zdravila, ki niso bila vključena v študije;
For major surgery in particular, close monitoring of the substitution therapy by means of coagulation analysis must be carried out. 
Predvsem pri večjih kirurških posegih je treba potek nadomestnega zdravljenja skrbno spremljati s testom strjevanja krvi.
Table 3: Frequency of adverse drug reactions MedDRA 
Preglednica 3: Pogostnost neželenih učinkov
What KOGENATE Bayer looks like and content of the pack 
Izgled zdravila KOGENATE Bayer in vsebina pakiranja
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 3000 IU) water for injections) in the prefilled syringe and the integrated transfer system (Bio-Set). 
Prašek zdravila KOGENATE Bayer se lahko rekonstituira le s priloženim vehiklom (2,5 ml (za 250 i.e., 500 i.e. in 1000 i.e) ali 5 ml (za 2000 i.e. in 3000 i.e.) vode za injekcije) v napolnjeni injekcijski brizgi in s priloženim sistemom za prenos vehikla (Bio-Set).
Gently screw the syringe on to the powder vial (B). 
Injekcijsko brizgo rahlo privijte na vialo s praškom (B).
You are filtering by using the vial adapter. 
Za filtriranje uporabite adapter za vialo.
1 vial with powder for solution for injection. 
VIALA S PRAŠKOM ZA RAZTOPINO ZA INJICIRANJE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - FOR VIAL ADAPTER 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - ADAPTER ZA VIALO
3000 IU) solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper) 
in 3000 i.e.) vehikla (valj iz prozornega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom brez lateksa)
When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation. 
Po infundiranjem bolniku s hemofilijo se faktor VIII v krvnem obtoku veže na vWF.
How to use KOGENATE Bayer 
Kako uporabljati zdravilo KOGENATE Bayer
A wide range of individual pdFVIII and rFVIII products are authorised for use in the European Union. 
V Evropski uniji ima dovoljenje za promet niz zdravil s pdFVIII in rFVIII.
Patients with inhibitors 
Bolniki z zaviralci
Inhibitors are less likely to occur in previously-treated patients (PTPs). 
Pri predhodno zdravljenih bolnikih (PTP) se zaviralci manj pogosto pojavijo.
Haemorrhage Early haemarthrosis, muscle bleed or oral bleed 
Krvavitev zgodnje krvavitve v sklepe, mišice ali ustno votlino
The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2 % per IU/kg body weight for KOGENATE Bayer. 
Iz analize podatkov o in vivo uporabnosti zdravila pri predhodno zdravljenih bolnikih z zdravilom KOGENATE Bayer so ugotovili, da 1 i.e. na kilogram telesne mase povprečno zviša aktivnost faktorja VIII za 2 %.
These therapies should be directed by physicians with experience in the care of patients with haemophilia. 
Ta zdravljenja morajo potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo.
OTHER Bayer-Logo 
DRUGI PODATKI Logotip Bayer
However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion. 
V in vitro študijah je bilo zdravilo v PVC vrečkah, pripravljeno za kontinuirano infuzijo, pri temperaturi 30 °C kemijsko in fizikalno stabilno 24 ur.
Animal reproduction studies have not been conducted with KOGENATE Bayer. 
Študije na živalih o vplivu zdravila KOGENATE Bayer na sposobnost razmnoževanja niso bile narejene.
Allergic type hypersensitivity reactions are possible with KOGENATE Bayer. 
Po uporabi zdravila KOGENATE Bayer se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 3000 IU) water for injections) in the prefilled syringe and the vial adapter. 
Prašek zdravila KOGENATE Bayer se lahko rekonstituira le s priloženim vehiklom (2,5 ml (za 250 i.e., 500 i.e. in 1000 i.e) ali 5 ml (za 2000 i.e. in 3000 i.e.) vode za injekcije) v napolnjeni injekcijski brizgi in z adapterjem za vialo.