FrancophonIA/ELRC3.0 huggingface dataset:
English: May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label.
Slovenian: Zdravilo lahko shranjujete pri temperaturi do 25 °C do 12 mesecev, vendar samo do datuma izteka roka uporabnosti navedenega na nalepki.
English: KOGENATE Bayer is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Slovenian: Ni verjetno, da bi zdravilo KOGENATE Bayer vplivalo na plodnost bolnikov ali bolnic, saj je zdravilna učinkovina v telesu naravno prisotna.
English: Do not refrigerate after reconstitution.
Slovenian: Po rekonstituciji raztopine ne shranjujte v hladilniku.
English: Fill the syringe by drawing the plunger out slowly and smoothly.
Slovenian: Napolnite injekcijsko brizgo tako, da počasi in mirno izvlečete bat brizge.
English: It is recommended that every time that you use KOGENATE Bayer, the name and batch number of the product are documented.
Slovenian: Priporočljivo je, da po vsaki uporabi zdravila KOGENATE Bayer zabeležite ime zdravila in številko serije.
English: If no further dose is required, remove the venipuncture set and syringe.
Slovenian: Če dodaten odmerek ni potreben, odstranite pribor za vensko punkcijo in injekcijsko brizgo.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: Zdravljenje naj traja vsaj 1 dan, dokler se krvavitev (glede na bolečino) ne ustavi oz. se rana ne zaceli.
English: • 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).
Slovenian: • 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.
English: If you use more KOGENATE Bayer than you should No cases of overdose with recombinant coagulation factor VIII have been reported.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer, kot bi smeli Ni poročil o prevelikem odmerjanju rekombinantnega koagulacijskega faktorja VIII.
English: • 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.
Slovenian: • 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.
English: If you are unsure about this, ask your doctor.
Slovenian: Če glede navedenega niste prepričani, se posvetujte z zdravnikom.
English: 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:
Slovenian: 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:
English: 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.
Slovenian: 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.
English: Do not shake vial.
Slovenian: Ne stresajte viale.
English: The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose (see end of section 2).
Slovenian: Druge sestavine zdravila so glicin, natrijev klorid, kalcijev klorid, histidin, polisorbat 80 in saharoza (glejte zadnji odstavek poglavja 2).
English: 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.
Slovenian: 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.
English: Other medicines and KOGENATE Bayer
Slovenian: Druga zdravila in zdravilo KOGENATE Bayer
English: 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
Slovenian: 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.
English: 2 dry swabs
Slovenian: 2 suha tampona
English: 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.
Slovenian: 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.
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Slovenian: Zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: 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).
Slovenian: 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).
English: Ensure that the powder is completely dissolved before use.
Slovenian: Preverite, da je pred uporabo ves prašek popolnoma raztopljen.
English: More extensive haemarthrosis, muscle bleed or haematoma
Slovenian: obsežnejše krvavitve v sklepe, mišice ali hematomi
English: Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children.
Slovenian: Otroci in mladostniki Navedena opozorila n previdnostni ukrepi veljajo za bolnike vseh starosti, odrasle in otroke.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Common (may affect up to 1 in 10 users):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: • chest tightness/general feeling of being unwell
Slovenian: • tiščanje v prsnem košu/splošno slabo počutje
English: • 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.
Slovenian: • 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).
English: Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: 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.
English: Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
Slovenian: Prašek glicin natrijev klorid kalcijev klorid histidin polisorbat 80 saharoza
English: 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).
Slovenian: 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).
English: Detailed instructions for reconstitution and administration of KOGENATE Bayer using vial with vial adapter:
Slovenian: Podrobnejša navodila za rekonstitucijo in uporabo zdravila KOGENATE Bayer pri uporabi vial z adaptarjem za vialo
English: If you forget to use KOGENATE Bayer
Slovenian: Če ste pozabili uporabiti zdravilo KOGENATE Bayer
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Neželeni učinki, navedeni v spodnji preglednici, so razvrščeni po organskih sistemih po klasifikaciji MedDRA (uporabljen je prednostni izraz po klasifikaciji MedDRA).
English: No interactions of KOGENATE Bayer with other medicinal products have been reported.
Slovenian: O medsebojnem delovanju zdravila KOGENATE Bayer z drugimi zdravili niso bile narejene.
English: Patients should be monitored for the development of factor VIII inhibitors.
Slovenian: Pri bolnikih je treba spremljati ali je prišlo do nastanka zaviralcev faktorja VIII.
English: • 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.
Slovenian: • 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.
English: The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution.
Slovenian: Rekonstituirano zdravilo je treba pred uporabo filtrirati, da se odstrani morebitne delce v raztopini.
English: The new expiry date must be noted on the outer carton.
Slovenian: Novi datum izteka roka uporabnosti zdravila mora biti naveden na zunanji ovojnini.
English: 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.
Slovenian: To zdravilo je namenjeno za injiciranje v veno, 2 do 5 minut, kar je odvisno od skupne količine raztopine in vašega počutja.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Če tudi večji odmerek ne bo zadostoval, se lahko zdravnik odloči za drugo zdravilo, koncentrat faktorja VIIa ali koncentrat (aktiviranega) protrombinskega kompleksa.
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5 II.
Slovenian: Potrebno število enot (i.e.) = telesna masa (kg) × želeni dvig faktorja VIII (% normalne vrednosti) × 0,5
English: 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.
Slovenian: 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.
English: Remove the stopper attached to the white cap from the syringe (A).
Slovenian: Odstranite zamašek, ki je pritrjen na belo zaporko injekcijske brizge (A).
English: Filtering is achieved by using the vial adapter.
Slovenian: Pri filtriranju je treba uporabiti adapter za vialo.
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN, ČE JE POTREBNO, POT(I) UPORABE voda za injekcije
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.
Slovenian: Podrobnejša navodila za pripravo in uporabo so v navodilu za uporabo, ki je priloženo zdravilu KOGENATE Bayer.
English: • 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.
Slovenian: • analiza študije SIPPET ne omogoča sklepanja o specifičnih zdravilih, saj se nanaša samo na majhno število določenih zdravil s FVIII.
English: When blood must be withdrawn prior to an infusion, use an administration set without a filter, then infuse KOGENATE Bayer through an injection filter.
Slovenian: Kadar je treba pred infundiranjem odvzeti kri, uporabite pribor brez filtra in nato infundirajte zdravilo KOGENATE Bayer skozi injekcijski filter.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Slovenian: Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
English: Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)
Slovenian: Bolezni imunskega sistema preobčutljivos tne kožne reakcije (pruritus, urtikarija in osip)
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: FVIII Inhibition (PTPs)*
Slovenian: zaviranje faktorja VIII (PZB)*
English: Hold the vial on end above the vial adapter and syringe (I).
Slovenian: Vialo držite nad adapterjem za vialo in injekcijsko brizgo (I).
English: 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]
Slovenian: 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.]
English: 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.
Slovenian: 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.
English: After reconstitution the solution is clear.
Slovenian: Po rekonstituciji je raztopina bistra.
English: • one pre-filled syringe with 2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and
Slovenian: • 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.
English: Do not use KOGENATE Bayer
Slovenian: Ne uporabljajte zdravila KOGENATE Bayer
English: There was also evidence for an increased risk with Refacto AF (another 3rd generation rFVIII) vs Advate, but only for all inhibitor development.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Peel off the paper cover on the vial adapter plastic housing.
Slovenian: Odstranite papirnat pokrov s plastičnega ohišja adapterja za vialo.
English: You must filter the reconstituted product before administration to remove any possible particles in the solution.
Slovenian: Rekonstituirano zdravilo morate pred uporabo filtrirati, da odstranite morebitne delce v raztopini.
English: KOGENATE Bayer contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Slovenian: Zdravilo KOGENATE Bayer vsebuje zdravilno učinkovino humani rekombinantni koagulacijski faktor VIII (oktokog alfa).
English: KOGENATE Bayer can be used in children of all ages.
Slovenian: Uporaba pri otrocih in mladostnikih Zdravilo KOGENATE Bayer se lahko uporablja pri otrocih vseh starosti.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG 51368 Leverkusen Nemčija
English: How to store KOGENATE Bayer Contents of the pack and other information
Slovenian: Shranjevanje zdravila KOGENATE Bayer Vsebina pakiranja in dodatne informacije
English: The SIPPET study
Slovenian: Študija SNIPPET
English: 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).
Slovenian: 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.
English: The analysis demonstrated that the frequency of inhibitor development is much lower in PTPs compared to PUPs.
Slovenian: Analiza je pokazala, da je pogostnost pojava zaviralcev veliko manjša pri predhodno zdravljenih kot pri predhodno nezdravljenih bolnikih.
English: INSTRUCTIONS ON USE Read package leaflet before use.
Slovenian: NAVODILA ZA UPORABO Pred uporabo preberite priloženo navodilo.
English: 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
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: For calculation of mL/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/mL).
Slovenian: Za izračun hitrosti infundiranja v ml/h se hitrost infundiranja i.e./h/kg pomnoži s kg telesne mase/koncentracija raztopine (i.e./ml).
English: Do not use the venipuncture set provided for drawing blood because it contains an in-line filter.
Slovenian: Priloženega pribora za vensko punkcijo ne uporabite za odvzem krvi, ker že vsebuje filter.
English: Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity.
Slovenian: Ne uporabite zdravila KOGENATE Bayer, če v raztopini opazite vidne delce ali je raztopina motna.