natgillin/translations-raw huggingface dataset:
A kidney disorder has been reported following high doses of plasma-derived factor IX to induce immune tolerance in haemophilia B patients with factor IX inhibitors and a history of allergic reactions (see also “Warnings and precautions”). 
Poročali so o motnji delovanja ledvic po dajanju velikih odmerkov faktorja IX, pridobljenega iz plazme, za indukcijo imunske tolerance pri bolnikih s hemofilijo B z inhibitorji faktorja IX in anamnezo alergijskih reakcij (glejte tudi “Opozorila in previdnostni ukrepi”).
Each vial of BeneFIX contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU of nonacog alfa. 
Ena viala zdravila BeneFIX vsebuje nominalno 250, 500, 1.000, 1.500, 2.000 ali 3.000 i.e. nonakoga alfa.
• one pre-filled syringe of solvent, 5 ml sterile 0.234% sodium chloride solution for injection for reconstitution, with one plunger rod 
• eno napolnjeno injekcijsko brizgo vehikla, 5 ml sterilne 0,234-odstotne raztopine natrijevega klorida za injekcije za rekonstitucijo, z enim batom,
Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided. 
Zaradi tveganja alergijskih reakcij pri koncentratih faktorja IX je treba opraviti začetne aplikacije faktorja IX, če lečeči zdravnik tako presodi, pod medicinskim nadzorom, kjer je možno nuditi ustrezno medicinsko oskrbo v primeru alergijskih reakcij.
LIST OF EXCIPIENTS Sucrose, glycine, L-histidine, sodium chloride, polysorbate 80. 
Saharoza, glicin, L-histidin, natrijev klorid, polisorbat 80.
Strength of BeneFIX per ml prepared solution 
Jakost zdravila BeneFIX na ml pripravljene raztopine
BeneFIX is provided as a powder for injection in a glass vial and a solvent provided in pre-filled syringe. 
Zdravilo BeneFIX je na voljo kot prašek za injekcijo v stekleni viali in vehikel, priložen v napolnjeni injekcijski brizgi.
Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced. 
Opomba: Če raztopine ne boste uporabili takoj, pazljivo namestite pokrovček brizge.
In addition, the solution should be withdrawn from the vial using the vial adapter. 
Poleg tega morate raztopino izvleči iz viale s pomočjo nastavka za vialo.
Children 6 to < 12 
Otroci 6 do < 12
Renal infarct l 
Bolezni sečil infarkt ledvice
Treatment failure can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment. 
Zaradi adsorpcije humanega koagulacijskega faktorja IX na notranjo površino nekaterih vrst infuzijske opreme lahko pride do neuspeha zdravljenja.
BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot. 
Zdravilo BeneFIX deluje tako, da pri bolnikih s hemofilijo B nadomesti faktor IX in omogoči strjevanje krvi.
Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required. 
Pri bolnikih s hemofilijo B aktivnosti faktorja IX ni ali je močno zmanjšana, tako da utegne biti potrebno nadomestno zdravljenje.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Allergic-type hypersensitivity reactions are possible with BeneFIX. 
Pri zdravilu BeneFIX so možne preobčutljivostne reakcije alergijskega tipa.
• one sterile infusion set 
•en sterilen infuzijski sistem,
BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU of powder in a 10 mL vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 mL of clear, colourless solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad. 
BeneFIX 250 i.e., 500 i.e., 1.000 i.e., 1.500 i.e., 2.000 i.e., 3.000 i.e. praška v 10-mililitrski viali (steklo tipa I) z zamaškom (iz klorobutila) in zaporko (iz aluminija) in 5 ml bistrega in brezbarvnega vehikla v napolnjeni injekcijski brizgi (steklo tipa I), zamašeni z batom (iz bromobutila), s koničastim pokrovčkom (iz bromobutila) in sterilnim rekonstitucijskim nastavkom za vialo, sterilen infuzijski sistem, dva alkoholna zloženca, obliž in blazinica iz gaze.
While holding the adapter in the package, place the vial adapter over the vial. 
Medtem ko držite nastavek v zavitku, ga namestite čez vialo.
BeneFIX is an injectable clotting (coagulation) factor IX product that is produced by recombinant DNA technology. 
Zdravilo BeneFIX je zdravilo za injiciranje s (koagulacijskim) faktorjem IX, izdelanim s tehnologijo rekombinantne DNA.
No adverse events have been reported in association with this observation. 
V povezavi s tem pojavom niso poročali o neželenih učinkih.
In case of severe allergic reactions, alternative therapy should be considered. 
V primeru hudih alergijskih reakcij je treba razmisliti o zdravljenju s kakšnim drugim zdravilom.
Do not remove the adapter from the package. 
Ne vzemite nastavka iz zavitka.
BeneFIX can cause harm to an unborn baby when given to pregnant women. 
Ni znano, ali lahko zdravilo BeneFIX, če ga prejemajo nosečnice, povzroči okvaro nerojenega otroka.
METHOD OF ADMINISTRATION Single use injection. 
Injekcija za enkratno uporabo.
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. 
Pri bolnikih s hemofilijo B se lahko razvijejo nevtralizirajoča protitelesa (inhibitorji) proti faktorju IX.
Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip. 
Ker uporabe zdravila BeneFIX s kontinuirano infuzijo niso ovrednotili, zdravila BeneFIX ne smete mešati z raztopinami za infundiranje ali dajati v kapalni infuziji.
The solvent syringe should be removed, leaving the vial adapter in place, and a separate large luer lock (a device that connects the syringe to the vial) syringe may be used to draw back the reconstituted contents of each individual vial. 
Brizgo z vehiklom odstranite, nastavek za vialo pustite na mestu, rekonstituirano vsebino vsake posamezne viale pa lahko posrkate s posebno, veliko brizgo z nastavkom po Luerju (naprava, ki spoji brizgo z vialo).
There is a potential risk of thromboembolic episodes following the administration of factor IX products, see section 4.4. 
Po uporabi zdravil s faktorjem IX obstaja tveganje za pojav trombemboličnih epizod (glejte poglavje 4.4).
Example: For a recovery of 0.8 IU/dL, the formula reads: Number of factor IX IU required 
Primer: za porast koncentracije za 0,8 i.e./dl je formula sledeča:
Because the use of BeneFIX by continuous infusion (drip) has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip. 
Ker uporabe zdravila BeneFIX s kontinuirano (kapalno) infuzijo niso ovrednotili, zdravila BeneFIX ne smete mešati z raztopinami za infundiranje ali dajati v kapalni infuziji.
In a randomized, cross-over pharmacokinetic study, BeneFIX reconstituted in 0.234% sodium chloride diluent was shown to be pharmacokinetically equivalent to the previously marketed BeneFIX (reconstituted with sterile water) in 24 previously treated patients (≥12 years) at a dose of 75 IU/kg. 
V randomizirani, navzkrižni farmakokinetični študiji so pri 24 predhodno zdravljenih bolnikih (≥ 12 let) pokazali, da je zdravilo BeneFIX v odmerku 75 i.e./kg, rekonstituirano v vehiklu 0,234 % natrijevega klorida, farmakokinetično ekvivalentno predhodno trženemu zdravilu BeneFIX (rekonstituiranemu z vodo za injekcije).
1500 IU 
1.500 i.e.
What BeneFIX looks like and contents of the pack 
Izgled zdravila BeneFIX in vsebina pakiranja
- The active substance is nonacog alfa (recombinant coagulation factor IX). 
Učinkovina je nonakog alfa (rekombinantni koagulacijski faktor IX).
Use only the pre-filled syringe provided in the box for reconstitution. 
Za rekonstitucijo uporabite le napolnjeno brizgo, ki je priložena v škatli.
Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries. 
Posamezni bolniki se lahko različno odzivajo na faktor IX, kar se kaže v različnih razpolovnih časih in porastih koncentracije faktorja IX.
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, generalised urticaria, itching, tightness of the chest, bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis. 
Bolnike je treba poučiti o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, generalizirana urtikarija, srbenje, tiščanje v prsnem košu, bronhospazem, laringospazem, sopenje, hipotenzija, zamegljen vid in anafilaksija.
To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing. 
Pomembno je, da omejite količino krvi, ki vstopi v infuzijski sistem, s čimer zmanjšate možnost aglutinacije.
Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. 
Pritrdite brizgo z vehiklom na nastavek za vialo, tako da vstavite vrh brizge v odprtino nastavka in hkrati čvrsto potiskate in sukate brizgo v smeri urnega kazalca, dokler se brizga in nastavek ne spojita.
The potency (IU) is determined using the European Pharmacopoeia one-stage clotting assay. 
Aktivnost (i.e.) določamo z enofaznim koagulacijskim testom po Evropski farmakopeji.
BeneFIX should be administered at a slow infusion rate. 
Zdravilo BeneFIX je treba infundirati z majhno hitrostjo.
There have been reports of clumping (agglutination) of red blood cells in the tube/syringe with the administration of BeneFIX. 
Poročali so o zlepljanju (aglutinaciji) rdečih krvničk v infuzijskem sistemu/brizgi ob dajanju zdravila BeneFIX.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for BeneFIX 
IME ZDRAVILA IN POT(I) UPORABE
Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding 
Zgodnja hemartroza, krvavitev v mišico ali v ustno votlino
Slowly depress the plunger rod to inject all the solvent into the BeneFIX vial 
S počasnim potiskanjem bata izbrizgajte ves vehikel v vialo z zdravilom BeneFIX.
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor IX activity in patients' blood samples, plasma factor IX activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. 
Kadar aktivnost faktorja IX v bolnikovih krvnih vzorcih določamo z enofaznim koagulacijskim testom na podlagi in vitro tromboplastinskega časa (aPTČ - aktivirani parcialni tromboplastinski čas), lahko na rezultate aktivnosti faktorja IX pomembno vplivata vrsta reagenta za aPTČ in referenčni standard, ki ga uporabljamo pri testiranju.
Solvent Sodium chloride solution 
Vehikel raztopina natrijevega klorida
Inadequate factor IX recovery p, 
Preiskave nezadosten porast faktorja IX
BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for injection with the supplied solvent (0.234% w/v sodium chloride solution) in the pre-filled syringe (see also section 3 of the package leaflet for reconstitution instructions). 
Zdravilo BeneFIX se daje z intravensko infuzijo po rekonstituciji liofiliziranega praška za injiciranje s priloženim vehiklom (0,234-odstotno (m/v) raztopino natrijevega klorida) v napolnjeni brizgi (za navodila za rekonstitucijo glejte tudi poglavje 3 navodila za uporabo).
How to take BeneFIX 
Kako uporabljati zdravilo BeneFIX
- Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (patients who have never received a previous infusion of factor IX), with BeneFIX. 
Iz kliničnih študij pri bolnikih, ki se zdravijo z zdravilom BeneFIX in pred tem niso prejemali zdravljenja (bolniki, ki nikoli niso prejeli infuzije faktorja IX), še niso pridobili dovolj podatkov.
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 and may in some cases progress to severe anaphylaxis (including shock). 
Opazili so preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in zbadanje na mestu infuzije, mrzlico, zardevanje, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, tiščanje v prsnem košu, mravljinčenje, bruhanje, sopenje), ki se lahko v nekaterih primerih razvijejo v hudo anafilaksijo (vključno s šokom).
BeneFIX should be administered using the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe. 
Zdravilo BeneFIX si morate dati s priloženo napolnjeno injekcijsko brizgo za vehikel ali z eno samo sterilno plastično injekcijsko brizgo za enkratno uporabo z nastavkom po Luerju.
Read the package leaflet before use. 
za intravensko uporabo, samo za enkratno uporabo Pred uporabo preberite priloženo navodilo!
Amount of BeneFIX per Vial 
Količina zdravila BeneFIX na vialo
It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX. 
Opozoriti je treba, da utegnejo biti bolniki z inhibitorji faktorja IX ob poznejšem ponovnem stiku s faktorjem IX v večji nevarnosti anafilaksije.
Allow the vial of lyophilised (freeze-dried) BeneFIX and the pre-filled syringe to reach room temperature. 
Vialo z liofiliziranim (sušenim z zamrzovanjem) zdravilom BeneFIX in napolnjeno injekcijsko brizgo z vehiklom segrejte na sobno temperaturo.
- Activity-neutralizing antibodies (inhibitors) are an uncommon event in patients who have received previous treatment with factor IX-containing products. 
Aktivnost nevtralizirajoča protitelesa (inhibitorji) se občasno pojavijo pri bolnikih, ki so že prejemali zdravila, ki vsebujejo faktor IX.
Such reactions may include swelling of the face or throat, burning and stinging at the infusion site, chills, flushing, itching, headache, hives, low blood pressure, lethargy, nausea, restlessness, fast heart rate, tightness of the chest, tingling, vomiting, wheezing). 
Te reakcije lahko vključujejo otekanje obraza ali žrela, pekoč občutek in zbadanje na mestu infuzije, mrzlico, zardevanje, srbenje, glavobol, koprivnico, nizek krvni tlak, letargijo, občutek siljenja na bruhanje, nemir, hiter srčni utrip, tiščanje v prsnem košu, mravljinčenje, bruhanje, sopenje.
- If you have any further questions, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
• one vial of BeneFIX 250, 500, 1000, 1500, 2000 or 3000 IU powder 
• eno vialo zdravila BeneFIX 250, 500, 1.000, 1.500, 2.000 ali 3.000 i.e. v obliki praška,
If clumping of red blood cells in the tubing/syringe is observed, discard all this material (tubing, syringe and BeneFIX solution) and resume administration with a new package. 
Če opazite zlepljanje rdečih krvničk v infuzijskem sistemu/brizgi, zavrzite ves material (infuzijski sistem, brizgo in raztopino zdravila BeneFIX) in nadaljujte z uporabo novega kompleta.
Early signs of allergic reactions include difficulty breathing, shortness of breath, swelling, hives, itching, generalised urticaria, tightness of the chest, wheezing, low blood pressure, blurred vision and anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands). 
izpuščaje, srbenje, generalizirano urtikarijo, tiščanje v prsnem košu, sopenje, nizek krvni tlak, zamegljen vid in anafilaksijo (huda alergijska reakcija, ki lahko povzroči težave pri požiranju in/ali dihanju, rdeč ali otekel obraz in/ali roke).
• one gauze pad 
•en obliž,
If agglutination of red blood cells in the tubing/syringe is observed, discard all this material (tubing, syringe and BeneFIX solution) and resume administration with a new package. 
Če opazite aglutinacijo rdečih krvničk v infuzijskem sistemu/brizgi, zavrzite ves material (infuzijski sistem, brizgo in raztopino zdravila BeneFIX) in aplikacijo nadaljujte z novim zavitkom.
Use the reconstituted solution immediately or within 3 hours. 
Rekonstituirano raztopino porabite takoj ali v 3 urah po rekonstituciji.
No MedDRA 17.1 PT was retrieved. 
V MedDRA 17.1 ni prednostnega izraza (PT - Preferred Term).
Dose based on bodyweight may require adjustment in underweight or overweight patients. 
Pri bolnikih s premajhno ali prekomerno telesno maso bo morda treba prilagoditi odmerek, odvisen od telesne mase.
BeneFIX should be administered immediately or within 3 hours after reconstitution. 
Zdravilo BeneFIX morate uporabiti nemudoma ali v 3 urah po rekonstituciji.
Discard the vial with the adapter attached. 
Zavrzite vialo skupaj s pritrjenim nastavkom.
No symptoms of overdose have been reported with recombinant coagulation factor IX products. 
Pri zdravilih z rekombinantnim koagulacijskim faktorjem IX niso poročali o nobenih simptomih prevelikega odmerjanja.
Number of subjects Clearance (mL/h/kg) 
Očistek (ml/h/kg)
BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU powder and solvent for solution for injection 
BeneFIX 250 i.e., 500 i.e., 1.000 i.e., 1.500 i.e., 2.000 i.e., 3.000 i.e. prašek in vehikel za raztopino za injiciranje
Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper. 
Zavitek pritisnite čvrsto navzdol, da se nastavek zaskoči na svoje mesto na vrhu viale, hkrati pa konica nastavka predre zamašek viale.
BeneFIX contains recombinant coagulation factor IX, (nonacog alfa). 
Zdravilo BeneFIX vsebuje rekombinantni koagulacijski faktor IX (nonakog alfa).
Do not use this medicine if you notice the solution is not clear or colourless. 
Če raztopina ni bistra in brez barve, zdravila ne uporabite.
3000 IU 
3.000 i.e.
m including injection site pain, infusion-site discomfort n including infusion-site pruritus, infusion-site erythema o including chest pain and chest tightness p 
vključno z bolečino na mestu injiciranja, neprijetnim občutkom na mestu infundiranja vključno s pruritusom na mestu infundiranja, eritemom na mestu infundiranja vključno z bolečino v prsnem košu in tiščanjem v prsnem košu to je dobesedni izraz.
The rate of administration should be determined by the patient's comfort level. 
Hitrost dajanja zdravila je treba prilagoditi bolnikovemu počutju.
The final solution should be inspected visually for fine particles before administration. 
Končno raztopino pred uporabo natančno preglejte glede prisotnosti vidnih delcev.
• one sterile vial adapter reconstitution device 
• en sterilen rekonstitucijski nastavek za vialo,
- See your doctor immediately if your bleeding does not stop as expected. 
Če se vam krvavitev ne ustavi, kot ste pričakovali, nemudoma obiščite zdravnika.
Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise. 
Odstranite brizgo z nastavka za vialo, tako da brizgo previdno povlečete in zasukate v smeri, nasprotni urnemu kazalcu.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistem inhibicija faktorja IX
600 IU 
600 i.e.
2000 IU 
2.000 i.e.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 5 ml of 0.234% sodium chloride solution for injection 
Vsebuje 5 ml 0,234-odstotne raztopine natrijevega klorida za injekcije.
Visual impairment e 
Očesne bolezni poslabšanje vida
BeneFIX is administered by intravenous (IV) infusion after reconstitution of the powder for injection with the supplied solvent (a sodium chloride (salt) solution) in the pre-filled syringe. 
infuzija po rekonstituciji praška za injiciranje s priloženim vehiklom (raztopina natrijevega klorida (soli)) v napolnjeni injekcijski brizgi.
1 pre-filled syringe with 5 ml solvent 1 sterile vial adapter reconstitution device 1 sterile infusion set 
1 sterilen rekonstitucijski nastavek za vialo 1 sterilen infuzijski sistem 2 alkoholna zloženca
How to store BeneFIX 
Shranjevanje zdravila BeneFIX
Inhibitors are an uncommon event in previously treated patients (PTPs) receiving factor IX-containing products. 
Pojav inhibitorjev pri predhodno zdravljenih bolnikih (PTP) z zdravili, ki vsebujejo faktor IX, je redek.
1000 IU 
1.000 i.e.
200 IU 
200 i.e.
Please contact your doctor immediately if you inject more BeneFIX than your doctor recommends. 
Če ste si injicirali več zdravila BeneFIX, kot vam je priporočil zdravnik, nemudoma obiščite zdravnika.
Aseptic technique (meaning clean and germ free) should be used during the reconstitution procedure. 
Med postopkom rekonstitucije morate uporabljati aseptično tehniko (t.j.
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX) 
BeneFIX 250 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 2.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 3.000 i.e. prašek in vehikel za raztopino za injiciranje nonakog alfa (rekombinantni koagulacijski faktor IX)
Potentially life-threatening anaphylactic reactions (severe allergic reactions) have occurred with factor IX products, including BeneFIX. 
Pri zdravilih s faktorjem IX, vključno z zdravilom BeneFIX, se pojavljajo anafilaktične reakcije (hude alergijske reakcije), ki so lahko življenjsko ogrožajoče.
BeneFIX contains recombinant coagulation factor IX, (INN = nonacog alfa). 
Zdravilo BeneFIX vsebuje rekombinantni koagulacijski faktor IX (INN = nonakog alfa).
Elimination half-life (h) Recovery (IU/dL per IU/kg) 
Razpolovni čas izločanja (h) Porast koncentracije faktorja IX (i.e./dl na i.e./kg)
If you get any side effects talk to your doctor, pharmacist or nurse. 
Če opazite katerikoli neželeni učinek, se posvetujte zzdravnikom, farmacevtom ali medicinsko sestro.
• Sleepiness, shaking 
• izpuščaj, koprivnica
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection 
BeneFIX 250 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 2.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 3.000 i.e. prašek in vehikel za raztopino za injiciranje
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction. 
Pri bolnikih s hemofilijo B z inhibitorji faktorja IX in anamnezo alergijske reakcije so poročali o nefrotskem sindromu po poskusu indukcije imunske tolerance.
Lot See front label (Lot, Exp.) 
Glejte sprednjo oznako (Številka serije, Uporabno do)
There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. 
Obstajajo literaturna poročila, ki kažejo korelacijo med pojavom inhibitorja faktorja IX in alergijskimi reakcijami, zato moramo bolnike, ki doživijo alergijsko reakcijo, testirati na prisotnost inhibitorja.
Very common 
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