FrancophonIA/ELRC3.0 huggingface dataset:
English: The procedures below are provided as guidelines for the reconstitution and administration of BeneFIX.
Slovenian: Spodaj opisani postopki naj služijo kot smernice za rekonstitucijo in uporabo zdravila BeneFIX.
English: deep vein thrombosis*; thrombosis*; thrombophlebitis*
Slovenian: globoka venska tromboza*, tromboza*, tromboflebitis*
English: - Allergic reactions are possible.
Slovenian: Možne so alergijske reakcije.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one mL of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja IX ustreza tej količini faktorja IX v enem ml normalne človeške plazme.
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Slovenian: Ker se hemofilija B pri ženskah pojavlja redko, izkušenj z uporabo faktorja IX med nosečnostjo in dojenjem ni na voljo.
English: The cap may need to be replaced (if not administering reconstituted BeneFIX immediately), so set it aside by placing it on its top.
Slovenian: Morda boste morali pokrovček namestiti nazaj (če rekonstituiranega zdravila BeneFIX ne boste uporabili takoj), zato ga začasno odložite, tako da ga postavite na njegov zgornji del.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Slovenian: Količino in pogostost uporabe zdravila je treba prilagoditi glede na klinično učinkovitost v posameznem primeru.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Naslednja preglednica nas lahko vodi pri odmerjanju v primerih krvavitev in operacije:
English: Side effects with unknown frequency (frequency cannot be estimated from the available data)
Slovenian: Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: The solution should appear clear and colourless.
Slovenian: Raztopina mora biti bistra in brezbarvna.
English: Abbreviations: AUC∞ = area under the plasma concentration-time curve from time zero to infinity; Cmax = peak concentration; t1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation.
Slovenian: Kratice: AUC∞ = površina pod plazemsko koncentracijsko krivuljo v odvisnosti od časa, od časa nič do neskončnosti; Cmax = največja plazemska koncentracija; t1/2 = razpolovni čas izločanja v plazmi; CL = očistek; SD = standardna deviacija.
English: In addition, pharmacokinetic parameters were followed up in 23 of the same patients after repeated administration of BeneFIX for six months and found to be unchanged compared with those obtained at the initial evaluation.
Slovenian: Poleg tega so pri 23 od teh bolnikov šest mesecev spremljali farmakokinetične parametre po večkratnem odmerjanju zdravila BeneFIX in ugotovili, da so v primerjavi s parametri, pridobljenimi pri prvotni oceni, nespremenjeni.
English: - If you are allergic to hamster proteins.
Slovenian: če ste alergični na beljakovine hrčka.
English: Do not take BeneFIX:
Slovenian: Ne uporabljajte zdravila BeneFIX:
English: However, the half-life of the product (see section 5.2) and the limited pharmacokinetic study data for the once-weekly regimen do not allow recommending this regimen in general for long-term prophylaxis in severe haemophilia B patients.
Slovenian: Vendar zaradi razpolovnega časa zdravila (glejte poglavje 5.2) in omejenih podatkov iz farmakokinetičnih študij za režim enkrat na teden na splošno tega režima ni mogoče priporočiti za dolgotrajno profilakso pri bolnikih s hudo hemofilijo B.
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Slovenian: O medsebojnem delovanju zdravil s humanim koagulacijskim faktorjem IX (rDNA) z drugimi zdravili niso poročali.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Slovenian: Če se pojavijo simptomi preobčutljivosti, je treba bolnikom svetovati, naj nemudoma prekinejo uporabo zdravila in se posvetujejo z zdravnikom.
English: If such inhibitors occur, a sign may be an increase in the amount of BeneFIX typically required to treat a bleed and or continued bleeding after treatment.
Slovenian: Če se taki inhibitorji pojavijo, se lahko to pokaže kot zvečanje količine zdravila BeneFIX, ki je običajno potrebna za zdravljenje krvavitev, in/ali kot nadaljnje krvavitve po zdravljenju.
English: No investigations on carcinogenicity, fertility impairment and foetal development have been conducted.
Slovenian: Študije kancerogenosti in vpliva na plodnost in na razvoj ploda niso bile izvedene.
English: Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Slovenian: Ponovite infuzijo vsakih 24 ur 3-4 dni ali dlje, dokler ne izzvenita bolečina in akutna nezmožnost.
English: This patient was able to continue treatment with BeneFIX with no anamnestic rise in inhibitor or anaphylaxis (see section 4.4).
Slovenian: Ta bolnik je lahko nadaljeval zdravljenje z zdravilom BeneFIX brez anamnestičnega porasta inhibitorja ali anafilaksije (glejte poglavje 4.4).
English: Slowly draw back all the solution into the syringe.
Slovenian: Počasi izvlecite vso raztopino v brizgo.
English: The table lists adverse reactions reported in the clinical trials of previously treated patients and identified in postmarketing use.
Slovenian: V preglednici so navedeni neželeni učinki, o katerih so poročali v kliničnih preskušanjih predhodno zdravljenih bolnikov in ki so jih odkrili v obdobju trženja.
English: Please dispose of all unused solution, empty vials and used needles and syringes in an appropriate container for throwing away waste as it may hurt others if not handled properly.
Slovenian: Vso neporabljeno raztopino, prazne viale in uporabljene injekcijske igle ter brizge odvrzite v ustrezen vsebnik za odpadke, saj lahko pri neustreznem ravnanju z odpadki ti predmeti ranijo ali poškodujejo druge osebe.
English: BeneFIX must be stored below 30°C and must be used by the expiry date on the label.
Slovenian: Zdravilo BeneFIX morate hraniti pri temperaturi do 30 °C in ga morate porabiti do datuma izteka roka uporabnosti, ki je naveden na oznaki.
English: The treatment required depends on the nature and severity of side-effects (see also “Warnings and precautions”).
Slovenian: Zahtevano zdravljenje je odvisno od narave in stopnje neželenih učinkov (glejte tudi “Opozorila in previdnostni ukrepi”).
English: It has a primary amino acid sequence that is comparable to the Ala allelic form of plasma-derived factor IX, and some post-translational modifications of the recombinant molecule are different from those of the plasma-derived molecule.
Slovenian: Ima primarno aminokislinsko sekvenco, ki je primerljiva z alelno obliko Ala148 iz plazme pridobljenega faktorja IX, in nekatere posttranslacijske modifikacije rekombinantne molekule se razlikujejo od tistih v molekuli, pridobljeni iz plazme.
English: Wipe the top of the vial with an alcohol swab provided, or use another antiseptic solution and allow to dry.
Slovenian: Obrišite vrh viale s priloženim alkoholnim zložencem ali s kakšno drugo antiseptično raztopino in pustite, da se posuši.
English: Age Group (years)
Slovenian: Starostna skupina (leta)
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also section 4.4).
Slovenian: V nekaterih primerih so se te reakcije razvile v hudo anafilaksijo in so se pojavile v tesni časovni povezavi z razvojem inhibitorjev faktorja IX (glejte tudi poglavje 4.4).
English: This is done by bending the cap up and down until the perforation is broken.
Slovenian: To naredite tako, da upogibate pokrovček navzgor in navzdol, dokler se ne prelomi po perforaciji.
English: Efficacy analysis in study 3090A1-301-WW was based on 22 evaluable paediatric subjects on prophylaxis regimen including 4 on-demand patients who shortly changed to prophylaxis.
Slovenian: Analiza učinkovitosti v študiji 3090A1-301-WW je temeljila na 22 ovrednotenih pediatričnih osebah, ki so se zdravile profilaktično, vključno s 4 bolniki, ki so se zdravili po potrebi in so kmalu prešli na profilaktično zdravljenje.
English: - The production of factor IX in the body is controlled by the factor IX gene.
Slovenian: Nastajanje faktorja IX v telesu nadzira gen za faktor IX.
English: Lot Pfizer Europe MA EEIG
Slovenian: Pfizer Europe MA EEIG
English: It is strongly recommended that every time BeneFIX 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: Močno priporočamo, da ob vsaki uporabi zdravila BeneFIX pri bolniku zabeležite ime in številko serije zdravila za ohranjanje povezave med bolnikom in serijo zdravila.
English: BeneFIX has no influence on the ability to drive or use machines.
Slovenian: Zdravilo BeneFIX nima vpliva na sposobnost vožnje in upravljanja strojev.
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, predvsem pri mlajših bolnikih, bodo morda potrebni krajši presledki med odmerjanjem ali večji odmerki.
English: • Thrombotic events (abnormal blood clots)
Slovenian: • trombotični dogodki (nenormalni krvni strdki)
English: Patients should follow the specific venipuncture procedures provided by their doctor.
Slovenian: Bolniki naj se ravnajo po specifičnih postopkih venepunkcije, ki jih bodo dobili od zdravnika.
English: FIX consumption for routine prophylaxis in 22 evaluable patients was 4607 ( 1849) IU/kg per year and 378 ( 152) IU/kg per month.
Slovenian: Poraba faktorja IX za rutinsko profilakso pri 22 ovrednotenih bolnikih je bila 4.607 ( 1.849) i.e./kg na leto in 378 ( 152) i.e./kg na mesec.
English: Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija B je spolno vezana dedna bolezen motnje koagulacije krvi zaradi zmanjšane ravni faktorja IX in povzroča obilne krvavitve v sklepe, mišice ali notranje organe, bodisi spontano, bodisi zaradi nezgodne ali kirurške travme.
English: The only documented serious adverse event related with BeneFIX was reported from the only included PUP, who experienced hypersensitivity and inhibitor development.
Slovenian: O edinemu zabeleženemu resnemu neželenemu učinku v povezavi z zdravilom BeneFIX so poročali pri edinemu vključenemu PUP, ki se mu je pojavila preobčutljivost in razvoj inhibitorja.
English: In case of severe allergic reactions, alternative haemostatic measures should be considered.
Slovenian: V primeru hudih alergijskih reakcij je treba razmisliti o drugih hemostatičnih ukrepih.
English: BeneFIX may increase the risk of thrombosis (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter.
Slovenian: Zdravilo BeneFIX lahko zveča tveganje tromboze (nenormalnih krvnih strdkov) v telesu, če imate dejavnike tveganja za nastajanje krvnih strdkov, vključno s stalnim venskim katetrom.
English: The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 224 subjects.
Slovenian: Pogostnost temelji na neželenih učinkih iz vseh vzrokov, ki so se pojavili med zdravljenjem v združenih kliničnih preskušanjih z 224 preskušanci.
English: Your doctor will decide the dose of BeneFIX you will receive.
Slovenian: Zdravnik bo določil odmerek zdravila BeneFIX, ki ga boste prejemali.
English: Mean dosage ( standard deviation) for prophylaxis was 63.7 ( 19.1) IU/kg at intervals of 3 to 7 days.
Slovenian: Povprečni odmerek ( standardna deviacija) za profilakso je 63,7 ( 19,1) i.e./kg v presledkih od 3 do 7 dni.
English: BeneFIX should be injected intravenously over several minutes.
Slovenian: Zdravilo BeneFIX morate vbrizgavati v veno več minut.
English: Always wash your hands prior to performing the following procedures.
Slovenian: Preden začnete s spodaj opisanimi postopki, si vedno najprej umijte roke.
English: The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dL (range from 0.4 to 1.4 IU/dL) in patients  12 years (further information in section 5.2).
Slovenian: Potrebni odmerek zdravila BeneFIX lahko izračunamo na podlagi ugotovitve, da ena enota aktivnosti faktorja IX na kilogram telesne mase pričakovano zviša raven faktorja IX v krvi za povprečno 0,8 i.e./dl (razpon od 0,4 do 1,4 i.e./dl) pri bolnikih  12 let (dodatne informacije so v poglavju 5.2).
English: Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of bleeding, and on the patient's clinical condition.
Slovenian: Odmerek in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja faktorja IX, mesta in obsega krvavitve ter bolnikovega kliničnega stanja.
English: Your doctor may want to monitor you for inhibitor development (see “Warnings and precautions”).
Slovenian: Zdravnik vas bo morda želel spremljati glede razvoja inhibitorja (glejte tudi “Opozorila in previdnostni ukrepi”).
English: Recombinant coagulation factor IX is a recombinant DNA-based protein therapeutic which has structural and functional characteristics comparable to endogenous factor IX.
Slovenian: Rekombinantni koagulacijski faktor IX je rekombinantno beljakovinsko zdravilo na podlagi DNA, katerega strukturne in funkcijske značilnosti so primerljive z endogenim faktorjem IX.
English: The safety and efficacy of BeneFIX administration by continuous infusion have not been established (see also sections 4.2 and 4.8).
Slovenian: Varnost in učinkovitost dajanja zdravila BeneFIX s kontinuirano infuzijo nista bili dokazani (glejte tudi poglavji 4.2 in 4.8).
English: • Chest discomfort (including chest pain)
Slovenian: • nelagodje v prsnem košu (vključno z bolečino v prsnem košu)
English: - Even in the absence of factor IX inhibitor, higher doses of BeneFIX may be needed than required for other plasma-derived factor IX products that you may have taken previously.
Slovenian: Celo v odsotnosti inhibitorja faktorja IX utegnejo biti potrebni večji odmerki zdravila BeneFIX, kot so potrebni za druga zdravila, ki vsebujejo faktor IX, pridobljen iz plazme, in ki ste jih morda jemali pred tem.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma).
Slovenian: Aktivnost faktorja IX v plazmi se izraža bodisi v odstotkih (glede na normalno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor IX v plazmi).
English: Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Slovenian: Bolnike z znanimi pomembnejšimi delecijskimi mutacijami na genu za faktor IX moramo skrbno opazovati glede znakov in simptomov akutnih preobčutljivostnih reakcij, še posebej v zgodnjih fazah začetne izpostavljenosti zdravilu.
English: The effect of BeneFIX on fertility has not been established.
Slovenian: Vpliv zdravila BeneFIX na plodnost ni bil dokazan.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Slovenian: Razvoj protiteles proti beljakovinam hrčka s povezanimi preobčutljivostnimi reakcijami so opazili zelo redko.
English: - After reconstitution with the supplied solvent (0.234% sodium chloride solution), each vial contains 50, 100, 200, 300, 400 or 600 IU/ml (see Table 1).
Slovenian: Po rekonstituciji s priloženim vehiklom (0,234-odstotna raztopina natrijevega klorida) ena viala vsebuje 50, 100, 200, 300, 400 ali 600 i.e./ml (glejte preglednico 1).
English: By replacement therapy the plasma levels of factor IX is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Slovenian: Z nadomestnim zdravljenjem se zviša plazemska raven faktorja IX, kar omogoči začasno korekcijo pomanjkanja faktorja in korekcijo nagnjenosti h krvavitvi.
English: Reconstitution and administration
Slovenian: Rekonstitucija in aplikacija
English: Cases of peripheral thrombophlebitis (pain and redness of the veins) and deep venous thrombosis (blood clots in the extremities) have also been reported; in most of these cases, BeneFIX was administered via continuous infusion, which is not an approved method of administration.
Slovenian: Poročali so tudi o primerih perifernega tromboflebitisa (boleče in rdeče obarvane vene) in globoke venske tromboze (krvni strdki v okončinah); v večini teh primerov so dajali zdravilo BeneFIX s kontinuirano infuzijo, kar ni odobren način uporabe.
English: Although BeneFIX contains only factor IX, the risk of thrombosis and disseminated intravascular coagulation (DIC) should be recognised.
Slovenian: Čeprav zdravilo BeneFIX vsebuje samo faktor IX, se moramo zavedati tveganja tromboze in diseminirane intravaskularne koagulacije (DIC).
English: If bleeding is not controlled with the recommended dose, contact your doctor.
Slovenian: Če priporočeni odmerek ne obvlada krvavitve, se posvetujte z zdravnikom.
English: A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX patients (including 9 patients participating only in the surgery study) who had previously received plasmaderived products.
Slovenian: Klinično pomemben inhibitor, ki je zmanjšal odziv na zdravljenje, so odkrili pri 1 od 65 bolnikov (vključno z 9 bolniki, ki so sodelovali le v kirurški študiji), zdravljenih z zdravilom BeneFIX, ki so predhodno prejeli zdravila, pridobljena iz plazme.
English: • Anaphylactic reaction
Slovenian: • anafilaktična reakcija
English: What BeneFIX is and what it is used for
Slovenian: Kaj je zdravilo BeneFIX in za kaj ga uporabljamo
English: BeneFIX may be administered for long term prophylaxis against bleeding in patients with severe haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for previously treated patients (PTP) was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days.
Slovenian: Zdravilo BeneFIX se lahko uporablja za dolgoročno profilakso krvavitev pri bolnikih s hudo hemofilijo B. V klinični študiji za rutinsko sekundarno profilakso je bil povprečni odmerek pri predhodno zdravljenih bolnikih (PTP - previously treated patients) 40 i.e./kg (razpon 13 do 78 i.e./kg) v presledkih 3 do 4 dni.
English: What you need to know before you take BeneFIX
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo BeneFIX
English: Patients can affix one of the peel-off labels found on the vial to document the batch number in their diary or for reporting any side effects.
Slovenian: Bolniki lahko eno od nalepk na viali nalepijo v svoj dnevnik, da dokumentirajo številko serije ali za poročanje o kakršnihkoli neželenih učinkih.
English: Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).
Slovenian: Ker je bila uporaba koncentratov kompleksa faktorja IX zgodovinsko povezana z razvojem trombemboličnih komplikacij, je lahko uporaba zdravil, ki vsebujejo faktor IX, potencialno nevarna pri bolnikih z znaki fibrinolize in bolnikih z diseminirano intravaskularno koagulacijo (DIC).
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Slovenian: Zaradi možnosti trombotičnih zapletov je potreben klinični nadzor glede zgodnjih znakov trombotične in porabnostne koagulopatije z ustreznim biološkim testiranjem, ko dajemo to zdravilo bolnikom z boleznimi jeter, bolnikom po operaciji, novorojenčkom ali bolnikom, pri katerih obstaja nevarnost trombotičnih pojavov ali DIC.
English: = body weight (in kg) X desired factor IX increase (%) or (IU/dL)
Slovenian: = telesna masa (v kg) X želeno zvišanje faktorja IX (%) ali (i.e./dl)
English: If you stop taking BeneFIX
Slovenian: Če ste prenehali uporabljati zdravilo BeneFIX
English: Allergic reactions may occur together with the development of factor IX inhibitor (see also “Warnings and precautions”).
Slovenian: Alergijske reakcije se lahko pojavijo v povezavi z razvojem inhibitorja faktorja IX (glejte tudi “Opozorila in previdnostni ukrepi”).
English: In two open-label studies BeneFIX was found to be safely administered at 100 IU/kg once-weekly.
Slovenian: V dveh odprtih študijah so ugotovili, da je mogoče zdravilo BeneFIX varno uporabljati v odmerku 100 i.e./kg enkrat na teden.
English: • Vision impairment (including blurred vision, appearance of spots/lights)
Slovenian: • poslabšan vid (vključno z zamegljenim vidom, pikami/svetlobo pred očmi)
English: The product may contain traces of hamster proteins (see Do not take BeneFIX).
Slovenian: Zdravilo lahko vsebuje sledove beljakovin hrčka (glejte ''Ne uporabljajte zdravila BeneFIX'').
English: Factor IX is activated by factor VII/tissue factor complex in the extrinsic pathway as well as factor XIa in the intrinsic coagulation pathway.
Slovenian: Faktor IX se aktivira s kompleksom faktorja VII/tkivnega faktorja v ekstrinzični poti in s faktorjem XIa v intrinzični koagulacijski poti.
English: There is limited documentation of on-demand treatment and surgery in paediatric patients less than 6 years of age treated with BeneFIX.
Slovenian: Na voljo so omejeni podatki o zdravljenju po potrebi ali v primeru operacije pri pediatričnih bolnikih, ki so mlajši od 6 let in so bili zdravljeni z zdravilom BeneFIX.
English: What BeneFIX is and what it is used for What you need to know before you take BeneFIX How to take BeneFIX
Slovenian: Kaj je zdravilo BeneFIX in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo BeneFIX Kako uporabljati zdravilo BeneFIX Možni neželeni učinki
English: Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin.
Slovenian: Aktivirani faktor IX v kombinaciji z aktiviranim faktorjem VIII aktivira faktor X, ki povzroči pretvorbo protrombina v trombin.
English: Recombinant coagulation factor IX is a single chain glycoprotein with an approximate molecular mass of 55,000 Daltons that is a member of the serine protease family of vitamin K-dependent coagulation factors.
Slovenian: Rekombinantni koagulacijski faktor IX je glikoprotein z eno samo verigo s približno molekulsko maso 55.000 daltonov, ki je član skupine serinskih proteaz, od vitamina K odvisnih koagulacijskih faktorjev.
English: Only the provided infusion set should be used.
Slovenian: Uporabljati se sme le priloženi infuzijski sistem.
English: Including tooth extraction Major
Slovenian: Manjše: vključno z ekstrakcijo zoba
English: Somnolence; tremor
Slovenian: • zaspanost, tresenje
English: The number of units of factor IX administered is expressed in International Units (IU), which is related to the current WHO standard for factor IX products.
Slovenian: Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i.e.), ki so prilagojene trenutnim standardom SZO za pripravke faktorja IX.