natgillin/translations-raw huggingface dataset:
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 začnite aplikacijo z novim zavitkom.
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 poročajo o nefrotičnem sindromu po poskusu indukcije imunske tolerance.
The safety and efficacy of using BeneFIX for immune tolerance induction has not been established.
Varnost in učinkovitost uporabe zdravila BeneFIX za indukcijo imunske tolerance še ni dokazana.
In the interest of patients, it is recommended that, whenever possible, every time that BeneFIX is administered to them, the name and batch number of the product is registered.
V interesu bolnikov je, da se, če je le mogoče, vsakokrat ko dobijo BeneFIX, zabeleži ime in številka serije zdravila.
Animal reproduction studies have not been conducted with factor IX.
Študije o vplivu na razmnoževanje pri živalih s faktorjem IX niso bile izvedene.
Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Zato naj se faktor IX uporablja med nosečnostjo in dojenjem le, če je brez dvoma indiciran.
To date, no adverse reactions reported in association with BeneFIX occurred with a frequency of ≥ 1/ 100 to < 1/ 10 (common).
Doslej se ni nobena od neželenih reakcij, o katerih poročajo v povezavi z zdravilom BeneFIX, pojavila s pogostostjo ≥ 1/ 100 do < 1/ 10 (pogosto).
The frequency of adverse reactions reported in association with BeneFIX would be categorized as uncommon (≥ 1/ 1000 to ≤ 1/ 100) or rare (≥ 1/ 10,000 to ≤ 1/ 1000).
Pogostost neželenih reakcij, o katerih poročajo v povezavi z zdravilom BeneFIX, bi uvrstili med občasne (≥ 1/ 1. 000 do ≤ 1/ 100) ali redke (≥ 1/ 10. 000 do ≤ 1/ 1. 000).
Of these the most significant include: anaphylaxis, cellulitis, phlebitis, and neutralising antibodies.
Najpomembnejše od teh vključujejo: anafilaksijo, celulitis, flebitis in nevtralizirajoča protitelesa.
Adverse reactions based on experience from clinical trials and postmarketing experience are presented below by system organ class and frequency of occurrence.
Neželene reakcije na podlagi izkušenj iz kliničnih preskušanj in na podlagi izkušenj po uvedbi zdravila na trg so v nadaljevanju predstavljene po skupinah organskih sistemov in pogostosti pojavljanja.
These frequencies have been estimated on a per- infusion basis and are described using the following categories: uncommon (≥ 1/ 1000 to ≤ 1/ 100); rare (≥ 1/ 10,000 to ≤ 1/ 1000).
Stopnje pogostosti so ocenili na posamezno infuzijo in so opisane po naslednjih kategorijah: občasno (≥ 1/ 1. 000 do ≤ 1/ 100); redko (≥ 1/ 10. 000 do ≤ 1/ 1. 000).
Dizziness, headache, altered taste, lightheadedness
omotica, glavobol, spremenjen okus, občutek prazne glave
6 Gastrointestinal disorders
Bolezni prebavil
Cellulitis, phlebitis, injection site reaction (including burning infusion site and injection site stinging), injection site discomfort
celulitis, flebitis, reakcije na mestu injiciranja (vključno s pekočim občutkom na mestu infuzije in zbadanjem na mestu injiciranja), neprijeten občutek na mestu injiciranja
Neutralising antibodies (factor IX inhibition)* Hypersensitivity/ allergic reactions; such reactions may include anaphylaxis*, bronchospasm/ respiratory distress, hypotension, angioedema, tachycardia, chest tightness, generalised urticarial, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/ sneezing
nevtralizirajoča protitelesa (inhibicija faktorja IX) * preobčutljivostne/ alergijske reakcije; takšne reakcije lahko vključujejo anafilaksijo *, bronhospazem/ dihalno stisko, hipotenzijo, angioedem, tahikardijo, stiskanje v prsih, generalizirano koprivnico, izpuščaj, pekoč občutek v čeljusti in lobanji, mrzlico (rigor), mravljinčenje, rdečico, letargijo, nemir, suh kašelj/ kihanje
* See additional
* Glejte dodatne informacije spodaj.
Hypersensitivity/ allergic reactions
Preobčutljivostne/ alergijske reakcije
Hypersensitivity or allergic reactions have been infrequently observed in patients treated with factor IX containing products, including BeneFIX.
Pri bolnikih, zdravljenih z zdravili, ki vsebujejo faktor IX, tudi z zdravilom BeneFIX, redko opazujejo preobčutljivostne ali alergijske reakcije.
In some cases, these reactions have progressed to severe anaphylaxis.
V nekaterih primerih reakcije lahko napredujejo v težko anafilaksijo.
Allergic reactions have occurred in close temporal association with development of factor IX inhibitor (see also section 4.4).
Alergijske reakcije se pojavljajo v tesni časovni povezanosti z razvojem inhibitorjev faktorja IX (glejte tudi poglavje 4. 4).
The aetiology of the allergic reactions to BeneFIX has not yet been elucidated.
Etiologija alergijskih reakcij na zdravilo BeneFIX še ni pojasnjena.
These reactions are potentially life-threatening.
Te reakcije so potencialno smrtno nevarne.
If allergic/ anaphylactic reactions occur, the administration of BeneFIX should be discontinued at once.
Če nastopijo alergijske/ anafilaktične reakcije, je potrebno uporabo zdravila BeneFIX nemudoma prekiniti.
The treatment required depends on the nature and severity of side-effects (see also section 4.4).
Potrebno zdravljenje je odvisno od narave in stopnje neželenih učinkov (glejte tudi poglavje 4. 4).
Due to the production process BeneFIX contains trace amounts of hamster cell proteins.
Zaradi postopka izdelave BeneFIX vsebuje sledove celičnih beljakovin hrčka.
Hypersensitivity responses can occur.
Lahko se pojavijo preobčutljivostni odzivi.
Inhibitor development
6 Razvoj inhibitorja
If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Če se taki inhibitorji pojavijo, se lahko stanje pokaže kot nezadosten klinični odziv.
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 plasma derived products.
Klinično relevanten inhibitor, ki je zmanjšal odziv na zdravljenje, so odkrili pri enem od 65 bolnikov (vključno z 9 bolniki, ki so sodelovali le v kirurški študiji), zdravljenih z zdravilom BeneFIX, ki so predhodno prejeli zdravila, izdelana iz plazme.
This patient was able to continue treatment with BeneFIX with no anamnestic rise in inhibitor or anaphylaxis.
Ta bolnik je lahko nadaljeval zdravljenje z zdravilom BeneFIX brez anamnestičnega porasta inhibitorja ali anafilaksije.
There are insufficient data to provide information on inhibitor incidence in PUPs.
Ni dovolj podatkov, da bi lahko posredovali informacije o pogostosti pojavljanja inhibitorjev pri PUPs.
Nephrotic syndrome 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.
Po velikih odmerkih faktorja IX, izdelanega iz plazme, za indukcijo imunske tolerance pri bolnikih s hemofilijo B z inhibitorji faktorja IX in anamnezo alergijskih reakcij so poročali o nefrotičnem sindromu.
7 Renal
Ledvice
In a clinical trial, twelve days after a dose of BeneFIX for a bleeding episode, one hepatitis C antibody positive patient developed a renal infarct.
V klinični študiji se je dvanajst dni po odmerku zdravila BeneFIX zaradi krvavitve pri enem bolniku, pozitivnem na protitelesa proti hepatitisu C, razvil infarkt ledvice.
The relationship of the infarct to prior administration of BeneFIX is uncertain.
Povezava med infarktom in predhodno uporabo zdravila BeneFIX je negotova.
The patient continued to be treated with BeneFIX.
Bolnik je nadaljeval zdravljenje z zdravilom BeneFIX.
Pharmacotherapeutic group: antihaemorrhagic Blood Coagulation Factor IX; ATC code:
Farmakoterapevtska skupina: krvni koagulacijski faktorji; oznaka ATC:
BeneFIX contains recombinant coagulation factor IX, (nonacog alfa).
BeneFIX vsebuje rekombinantni koagulacijski faktor IX (nonakog alfa).
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.
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.
Factor IX is activated by factor VII/ tissue factor complex in the extrinsic pathway as well as factor XIa in the intrinsic coagulation pathway.
Faktor IX se aktivira s kompleksom faktorja VII/ tkivnega faktorja v ekstrinzični poti in s faktorjem XIa v intrinzični koagulacijski poti.
This results ultimately in the conversion of prothrombin to thrombin.
Aktivirani faktor IX v kombinaciji z aktiviranim faktorjem VIII aktivira faktor X, ki povzroči pretvorbo protrombina v trombin.
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 potrebna substitucijska terapija.
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.
S substitucijsko terapijo se zviša plazemska raven faktorja IX, kar omogoči začasno korekcijo pomanjkanja faktorja in korekcijo nagnjenosti h krvavitvi.
There are insufficient data to recommend the use of BeneFIX in children less than 6 years of age.
Podatkov je premalo, da bi lahko priporočili uporabo zdravila BeneFIX pri otrocih, mlajših od 6 let.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
7 Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
Infusion of BeneFIX into 56 PTP patients (baseline data) with haemophilia B has shown an in vivo recovery ranging from 15 to 62% (mean 33.7 +/ - 10.3%).
Infuzija zdravila BeneFIX pri 56 PTP bolnikih (izhodiščni podatki) s hemofilijo B je pokazala in vivo porast aktivnosti faktorja IX od 15 do 62% (povprečno 33, 7 + / - 10, 3%).
One International Unit of BeneFIX showed a mean 0.75 IU/ dl (range 0.3 to 1.4 IU/ dl) increase in the circulating level of factor IX.
Ena mednarodna enota zdravila BeneFIX je pokazala povprečno zvišanje ravni faktorja IX v krvi za 0, 75 i. e. / dl (razpon 0, 3 do 1, 4 i. e. / dl).
The biologic half- life ranged from 11 to 36 hours (mean of 19.3 +/ - 5.0 hours).
Biološki razpolovni čas je segal od 11 do 36 ur (povprečje 19, 3 + / - 5, 0 ur).
For a subset of the 56 patients, data are available from baseline to 24 months.
Za podskupino teh 56 bolnikov so na voljo podatki do 24 mesecev.
The pharmacokinetic data for these patients at various time points are shown in the following table:
Farmakokinetični podatki za te bolnike v različnih časovnih točkah so prikazani v naslednji preglednici:
Recombinant Factor IX Summary of Pharmacokinetic Parameters for Activity Data by Month in Previously Treated Patients
33, 7 31, 8 31, 3 30, 7 31, 0
Parameter Recovery (%)
31, 5 31, 0 30, 5 28, 9 30, 6
Month n Mean Median SD Range 95% CI 0 56 33.7 31.5 10.31 15.3– 62.2 30.9, 36.4 6 53 31.8 31.0 9.04 15.3– 56.7 29.4, 34.3 12 50 31.3 30.5 8.75 16.2 – 53.1 28.8, 33.7 18 47 30.7 28.9 9.24 12.6– 62.1 28.0, 33.5 24 47 31.0 30.6 8.80 16.2– 59.4 28.4, 33.6
30, 9, 36, 4 29, 4, 34, 3 28, 8, 33, 7 28, 0, 33, 5 28, 4, 33, 6
FIX increase (IU/ dl per IU/ kg)
0, 23 0, 20 0, 19 0, 21 0, 20
0 56 0.75 0.70 0.23 0.34– 1.38 0.69, 0.81 6 53 0.71 0.69 0.20 0.34– 1.26 0.65, 0.76 12 50 0.70 0.68 0.19 0.36 – 1.18 0.64, 0.75 18 47 0.68 0.64 0.21 0.28– 1.38 0.62, 0.74 24 47 0.69 0.68 0.20 0.36– 1.32 0.63, 0.75
0, 69, 0, 81 0, 65, 0, 76 0, 64, 0, 75 0, 62, 0, 74 0, 63, 0, 75
Elimination half-life (hrs)
Eliminacijski razpolovni čas (h)
0 56 19.3 19.1 4.97 11.1– 36.4 18.0, 20.7 6 53 19.8 18.2 6.26 9.6– 38.2 18.1, 21.6 12 49 18.5 16.6 5.89 10.6 – 33.7 16.8, 20.2 18 46 18.9 16.3 7.02 10.7– 38.3 16.8, 21.0 24 45 18.9 17.3 6.84 10.9– 42.2 16.8, 20.9
18, 0, 20, 7 18, 1, 21, 6 16, 8, 20, 2 16, 8, 21, 0 16, 8, 20, 9
AUC0- ∞ (IU × hr/ dl) Half-life
AUC0- ∞ (i. e. × h/ dl)
0 56 619.8 605.2 155.7 366.5– 1072.6 578.1, 661.5 6 53 579.8 562.2 146.1 330.9– 900.1 539.5, 620.1 12 49 575.7 566.0 151.0 290.3 – 1080.8 532.4, 619.1 18 46 561.8 560.9 155.6 254.5– 940.8 515.7, 608.0 24 45 577.6 551.7 154.7 284.1– 1045.4 531.1, 624.1 0 54 2.0 1.5 1.60 0.07-5.73 1.6,2.5
366, 5– 1072, 6 330, 9– 900, 1
Initial Phase (hrs)
578, 1, 661, 5 539, 5, 620, 1
0.12-9.98 0.13-14.34 0.13-6.21 0.11-7.43
0, 07- 5, 73 0, 12- 9, 98 0, 13- 14, 34 0, 13- 6, 21 0, 11- 7, 43
Clearance (ml/ hr/ kg)
Očistek (ml/ h/ kg)
8.4 9.2 9.3 9.6 9.2
84 9, 2 9, 3 9, 6 9, 2
Data exclude those collected from one patient after evidence of inhibitor development was observed at 9 months.
Podatki ne vsebujejo podatkov, zbranih pri enem bolniku, pri katerem so ugotovili znake razvoja inhibitorja pri 9 mesecih.
AUC0 - ∞ = Area Under the Curve MRT = Mean Residence Time SD = Standard Deviation CI = Confidence Interval
AUC0 - ∞ = površina pod krivuljo MRT = povprečni čas prisotnosti v obtoku SD = standardna deviacija CI = interval zaupanja
A 28% lower recovery of recombinant Factor IX in comparison to plasma derived Factor IX was shown.
Izkazalo se je, da je porast aktivnosti rekombinantnega faktorja IX za 28% manjši od porasta aktivnosti faktorja IX, izdelanega iz plazme.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple intravenous doses in different species.
Farmakokinetični parametri, dobljeni v študijah, v katerih so primerjali rekombinantni faktor IX in faktor IX, izdelan iz plazme, so bili podobni tistim, ki so jih dobili v študijah pri ljudeh.
The pharmacokinetic parameters obtained in studies comparing
Zdi se, da k različnemu porastu aktivnosti rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz
9 recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
9 plazme, prispevajo strukturne razlike molekule rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme.
Powder Sucrose Glycine L-Histidine Polysorbate 80
Prašek saharoza glicin L- histidin polisorbat 80
Solvent Water for injection
Vehikel voda za injekcije
3 years
6. 3 Rok uporabnosti
The reconstituted product should be used immediately, but no longer than 3 hours after reconstitution.
3 leta
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25oC.
Rekonstituirano raztopino je potrebno po možnosti uporabiti takoj, najpozneje pa v 3 urah po rekonstituciji.
For the purpose of ambulatory use the product may be removed from refrigerated storage for one single period of maximum 1 month at room temperature (up to 25 ºC).
Za ambulantno uporabo smete vzeti zdravilo iz hladilnika za eno samo obdobje, ki ne sme biti daljše od 1 meseca, pri sobni temperaturi (do 25 ºC).
At the end of this period, the product should not be put back in the refrigerator, but should be used or discarded.
Po koncu tega obdobja zdravila ne smete spraviti nazaj v hladilnik, ampak ga morate porabiti ali zavreči.
250 IU of powder in a vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium).
250 i. e. praška v viali (steklo tipa I) z zamaškom (iz klorobutilne gume) in zaporko (iz aluminija).
A tip-cap (bromobutyl) and a sterile filter spike, a sterile infusion set, two alcohol swabs, two plasters.
Pokrovček (iz bromobutilne gume) in sterilna prebodna igla z vgrajenim filtrom in zračnikom, sterilen infuzijski sistem, dva alkoholna zloženca, dva obliža.
10 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Detailed instructions for preparation and administration are contained in the user package leaflet provided with BeneFIX.
Natančna navodila za pripravo in uporabo so v navodilu za uporabo za bolnika, ki je priloženo zdravilu BeneFIX.
Reconstitute lyophilised BeneFIX powder for solution for injection with the supplied solvent (water for injection) using the sterile double-ended transfer needle.
10 Rekonstituirajte liofilizirani prašek za raztopino za injiciranje BeneFIX s priloženim vehiklom (vodo za injekcije) s sterilno iglo za prenos z dvema konicama.
Reconstitution should be performed on a flat level surface such as a table to ensure that the needle is positioned properly on top of the vial, inserted vertically i. e. perpendicular to the stopper surface Gently rotate the vial until all powder is dissolved.
Vialo nežno sukajte, dokler se ves prašek ne raztopi.
After reconstitution, the solution is drawn through the sterile filter spike (supplied) into a sterile disposable syringe.
Po rekonstituciji raztopino povlecite skozi sterilno prebodno iglo z vgrajenim filtrom in zračnikom (priložena) v sterilno brizgo za enkratno uporabo.
The solution should be discarded if visible particulate matter or discolouration is observed.
Če opazite vidne delce ali spremenjeno barvo, je potrebno raztopino zavreči.
BeneFIX is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied water for injections.
BeneFIX se daje z intravensko (i. v.) injekcijo po rekonstituciji liofiliziranega praška za injekcijo s priloženo vodo za injekcije.
BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2- ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Kadar je rekonstituiran, BeneFIX vsebuje polisorbat- 80, za katerega je znano, da poveča hitrost izločanja di - (2- etilheksil) ftalata (DEHP) iz polivinilklorida (PVC).
It is important that the recommendations in section 4.2 be followed closely.
Pomembno je, da boste dosledno upoštevali navodila v poglavju 4. 2.
The reconstituted solution should be used immediately or within 3 hours.
Rekonstituirano raztopino je potrebno porabiti takoj ali najpozneje v 3 urah.
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Velika Britanija
27 August 1997 Date of last renewal:
27. avgust 1997 Datum zadnjega podaljšanja:
Detailed information on this medicinal product is available on the website of the European Medicine Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
BeneFIX 500 IU powder and solvent for solution for injection.
BeneFIX 500 i. e. prašek in vehikel za raztopino za injiciranje.
Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX).
Ena viala vsebuje nominalno 500 i. e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
After reconstitution with the accompanying 5 ml water for injection, each ml of the solution contains approximately 100 IU/ ml nonacog alfa.
Po rekonstituciji s priloženimi 5 ml vode za injekcije en mililiter raztopine vsebuje približno 100 i. e. / ml nonakoga alfa.
Each vial contains 50 mg sucrose.
Ena viala vsebuje 50 mg saharoze.
13 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Količino in pogostost uporabe zdravila je potrebno prilagoditi glede na klinično učinkovitost v posameznem primeru.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
12 Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i. e.), ki so prilagojene trenutnim standardom SZO za pripravke faktorja IX.
Repeat infusion every 8-24 hours
Ponavljajte infuzijo vsakih 8 do 24 ur,
For long term prophylaxis against bleeding in patients with severe haemophilia B, BeneFIX may be administered.
13 Za dolgoročno profilakso krvavitev pri bolnikih s težko hemofilijo B lahko uporabljamo BeneFIX.
In most of the cases, an infusion rate of up to 4 ml per minute has been used.
V večini primerov so uporabljali hitrost infuzije do 4 ml na minuto.
The rate of administration should be determined by the patient’ s comfort level.
Hitrost dajanja zdravila je treba prilagoditi bolnikovemu počutju.
15 4.3 Contraindications
4. 3 Kontraindikacije
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, hypotension, and anaphylaxis.
14 Bolnike je potrebno informirati o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, srbenje, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
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
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).
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 neonates, or to patients at risk of thrombotic phenomena or DIC.
Zaradi možnosti trombotičnih zapletov je potreben klinični nadzor 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.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available.
Ker se hemofilija B pri ženskah pojavlja redko, izkušenj z uporabo faktorja IX med nosečnostjo in dojenjem ni na voljo.
4.7 Effects on ability to drive and use machines
15 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
These frequencies have been estimated on a per- infusion basis and are described using the following categories: uncommon (≥ 1/ 1000 to ≤ 1/ 100); rare (≥ 1/ 10,000 to ≤ 1/ 1000).
Stopnje pogostosti so ocenili na posamezno infuzijo in so opisane po sledečih kategorijah: občasno (≥ 1/ 1. 000 do ≤ 1/ 100); redko (≥ 1/ 10. 000 do ≤ 1/ 1. 000).
17 Nervous system disorders
Bolezni živčevja
Neutralising antibodies (factor IX inhibition)* Hypersensitivity/ allergic reactions; such reactions may include anaphylaxis*, bronchospasm/ respiratory distress, hypotension, angioedema, tachycardia, chest tightness, generalised urticarial, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/ sneezing
nevtralizirajoča protitelesa (inhibicija faktorja IX) * preobčutljivostne/ alergijske reakcije; takšne reakcije lahko vključujejo anafilaksijo *, bronhospazem/ dihalno stisko, hipotenzijo, angioedem, tahikardijo, stiskanje v prsih, generalizirano koprivnico, izpuščaje, pekoč občutek v čeljusti in lobanji, mrzlico (rigor), mravljinčenje, rdečico, letargijo, nemir, suh kašelj/ kihanje
Due to the production process BeneFIX contains trace amounts of hamster cell proteins.
16 Zaradi postopka izdelave BeneFIX vsebuje sledove celičnih beljakovin hrčka.
18 Renal
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