FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have to undergo surgery or have a tooth extracted, inform your doctor or dentist that you have factor IX deficiency.
Slovenian: Če vam morajo opraviti operacijo ali izruvati zob, obvestite vašega zdravnika ali zobozdravnika, da imate pomanjkanje faktorja IX.
English: The clinical relevance of antibodies to mouse protein, if these do indeed arise, is not known.
Slovenian: Klinični pomen protiteles proti mišjim beljakovinam, če se ta res pojavijo, ni znan.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, even those not prescribed.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi takšna, ki se izdajajo brez recepta.
English: Renewal of authorisation: 03 July 2006
Slovenian: Datum pridobitve dovoljenja za promet: 3. julij 2001 Podaljšanje dovoljenja za promet: 3. julij 2006
English: They will then ensure that factor IX is administered to you, should this prove necessary.
Slovenian: Oni bodo potem poskrbeli, da boste prejeli faktor IX, če bo to potrebno.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora posredovati periodično posodobljena poročila o varnosti skladno z zahtevami, opredeljenimi na seznamu referenčnih datumov EU (seznamom EURD), ki je naveden v členu 107c(7) Direktive 2001/83/ES in objavljen na spletnem portalu Evropske agencije za zdravila.
English: Reporting of side effects
Slovenian: Poročanje o stranskih učinkih
English: The use of high purity factor IX is rarely associated with such adverse reactions.
Slovenian: Uporabo visoko prečiščenega faktorja IX le redko povezujejo s takimi neželenimi učinki.
English: If you have the impression that the effect of Nonafact is too strong or too weak, talk to your doctor.
Slovenian: Če menite, da je učinek zdravila Nonafact premočan ali prešibak, se posvetujte s svojim zdravnikom.
English: These are conditions that increase your risk of developing internal blood clots.
Slovenian: To so stanja, ki povečujejo vaše tveganje za razvoj krvnih strdkov.
English: Disinfect the surface of the stoppers of both vials with a gauze soaked in 70 % alcohol.
Slovenian: Razkužite površino zapork obeh vial z gazo, prepojeno s 70 % alkoholom.
English: If you are allergic to human coagulation factor IX or to any of the ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na humani koagulacijski faktor IX ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: BATCH NUMBER Lot: {number}
Slovenian: ŠTEVILKA SERIJE Lot: {številka}
English: This also applies to newborn babies and patients with an increased risk of thrombosis or “DIC” (disseminated intravascular coagulation) a disease in which the blood coagulation system is disturbed.
Slovenian: To velja tudi za novorojenčke in bolnike s povečanim tveganjem za trombozo ali »DIK« (diseminirano intravaskularno koagulacijo),bolezen pri kateri je moteno delovanje sistema strjevanja krvi.
English: Neutralising antibodies (Inhibitors)
Slovenian: Nevtralizirajoča protitelesa (inhibitorji)
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Slovenian: Posamezni bolniki se lahko v svojem odzivu na faktor IX razlikujejo ter izkazujejo različne razpolovne čase in okrevanje.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Slovenian: Pediatrična populacija Navedena opozorila in previdnostni ukrepi veljajo za odrasle in otroke.
English: DD month YYYY
Slovenian: DD mesec LLLL
English: Once dissolved, the product should be used immediately (at least within 3 hours).
Slovenian: Ko je zdravilo enkrat raztopljeno, ga moramo takoj uporabiti (najpozneje v 3 urah).
English: Factor IX in this product therefore behaves like endogenous factor IX.
Slovenian: Faktor IX v tem zdravilu se torej obnaša kot endogeni faktor IX.
English: Your doctor will check your blood regularly for the presence of these antibodies.
Slovenian: Vaš zdravnik vam bo redno pregledoval kri za morebitno navzočnost teh protiteles.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V takih primerih priporočamo posvetovanje s specializiranim centrom za hemofilijo.
English: Your doctor will check your blood regularly for the presence of these antibodies, especially if you experienced a severe allergic reaction with the previous use of a factor IX product.
Slovenian: Vaš zdravnik bo redno pregledoval vašo kri zaradi možne prisotnosti teh protiteles, še posebej, če ste doživeli hudo alergijsko reakcijo ob uporabi zdravila s faktorjem IX v preteklosti.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V *.
Slovenian: Zdravstveno osebje mora o kakršnih koli domnevnih neželenih učinkih poročati prek nacionalnega sistema za poročanje, ki je naveden v Prilogi V.*
English: Factor IX is a normal constituent of human blood.
Slovenian: Faktor IX je normalna sestavina človeške krvi.
English: If you are allergic to mouse protein or have had any reactions to mouse protein.
Slovenian: Če ste alergični na mišje beljakovine ali ste imeli kakršno koli reakcijo na mišje beljakovine.
English: for intravenous use
Slovenian: za intravensko uporabo
English: Viral safety
Slovenian: Virusna varnost
English: Swirl the vial gently to completely dissolve the powder within 5 minutes.
Slovenian: Nežno vrtite vialo, da popolnoma raztopite prašek v 5 minutah.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Slovenian: Zato moramo pri bolnikih z alergijskimi reakcijami preveriti navzočnost inhibitorja.
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Slovenian: Faktor IX je enoverižni glikoprotein z molekulsko maso približno 68.000 Daltonov.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Slovenian: Zdravljenje mora potekati pod nadzorom zdravnika, izkušenega v zdravljenju hemofilije.
English: Minor surgery including tooth extraction
Slovenian: Manjši kirurški posegi, vključno z izruvanjem zoba
English: The product should be used immediately.
Slovenian: Zdravilo morate uporabiti takoj.
English: Nonafact has a half-life of approximately 19 (17 - 21) hours.
Slovenian: Zdravilo Nonafact ima razpolovni čas približno 19 (od 17 do 21) ur.
English: The exact dose will depend on the seriousness of the clinical situation, your body weight and the amount of factor IX in your blood.
Slovenian: Točni odmerek bo odvisen od resnosti kliničnega stanja, vaše telesne mase in količine faktorja IX v vaši krvi.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Slovenian: Aktivirani faktor IX v kombinaciji z aktiviranim faktorjem VIII aktivira faktor X. Aktivirani faktor X pretvori protrombin v trombin.
English: MM/YYYY
Slovenian: MM/LLLL
English: From a microbiological point of view the product, once dissolved, should be used immediately, but no longer than 3 hours after reconstitution.
Slovenian: Z mikrobiološkega vidika je treba zdravilo, ko ga enkrat raztopimo, nemudoma uporabiti, toda ne kasneje kot 3 ure po rekonstituciji.
English: (pre- and postoperative)
Slovenian: (pred in po operaciji)
English: 1066 CX Amsterdam The Netherlands
Slovenian: 1066 CX Amsterdam Nizozemska
English: You should tell your doctor if you know that you have a risk of thrombosis or you have had thromboembolic complications in the past, if you suffer from liver disease, cardiovascular disease, or if a surgery is planned.
Slovenian: Zdravniku morate sporočiti, če veste, da pri vas obstaja tveganje tromboze ali ste v preteklosti imeli trombembolične zaplete, če imate obolenje jeter, srčno-žilno bolezen ali načrtovan kirurški poseg.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.
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 za dajanje in pogostost dajanja moramo vedno določiti glede na klinično učinkovitost pri posameznem bolniku.
English: This leaflet was last approved
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: 20-40 Repeat infusion every 24 hours.
Slovenian: 20-40 Ponovite infuzijo vsakih 24 ur.
English: Dissolving the powder
Slovenian: Raztapljanje praška
English: • A vial water for injections containing 5 ml or 10 ml
Slovenian: • vialo vode za injekcije, ki vsebuje 5 ml ali 10 ml
English: Nonafact may be self-administered if it is an approved practice in your country and when you have been trained sufficiently.
Slovenian: Zdravilo Nonafact si lahko date sami, če je to dovoljeno v vaši državi in po ustreznem usposabljanju.
English: Frequency of doses (hours)/ Duration of therapy (days)
Slovenian: Pogostnost odmerjanja (ure)/Trajanje zdravljenja (dnevi)
English: It is recommended that the rate of administration should not exceed 2 ml/min.
Slovenian: Intravenska uporaba Priporočamo, da naj hitrost dajanja ne presega 2 ml/min.
English: In the case of a severe allergic reaction (anaphylactic shock), immediately stop the administration of the product and contact your doctor immediately.
Slovenian: V primeru hude alergijske reakcije (anafilaktični šok), nemudoma prekinite dajanje zdravila in takoj pokličite svojega zdravnika.
English: In each of these situations, the benefit of treatment with Nonafact should be weighed against the risk of these complications.
Slovenian: V vsaki od teh situacij moramo pretehtati korist zdravljenja z zdravilom Nonafact s tveganjem za te zaplete.
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 4.4).
Slovenian: V nekaterih primerih so te reakcije napredovale v hudo anafilaksijo, pojavljale pa so se v tesni časovni povezavi z razvojem inhibitorjev faktorja IX (glejte tudi poglavje 4.4).
English: Known allergic reaction to mouse protein.
Slovenian: Znana alergijska reakcija na mišje beljakovine.
English: This also applies to any unknown or emerging viruses or other types of infections.
Slovenian: To velja tudi za doslej neznane ali na novo pojavljajoče se viruse ali druge oblike okužb.
English: Bring the two vials to a temperature between 15°C and 25°C.
Slovenian: Ogrejte obe viali na temperaturo med 15 °C in 25 °C.
English: The administration of Nonafact can compensate for this deficiency.
Slovenian: Uporaba zdravila Nonafact lahko nadomesti to pomanjkanje.
English: Your doctor will decide how much Nonafact you require.
Slovenian: Vaš zdravnik bo odločil, koliko zdravila Nonafact potrebujete.
English: Nonafact contains sodium chloride
Slovenian: Zdravilo Nonafact vsebuje natrijev klorid
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Slovenian: V literaturi so poročali o korelaciji med pojavom inhibitorja faktorja IX in alergijskimi reakcijami.
English: Where necessary, mild allergic reactions, such as hives, can be treated with antihistamines (medicinal products which counteract allergies).
Slovenian: Po potrebi lahko blage alergijske reakcije, kot je koprivnica, zdravimo z antihistaminiki (zdravili proti alergijam).
English: Water for injections
Slovenian: voda za injekcije
English: In pharmacodynamic studies in rabbits and guinea pigs, the thrombogenicity of Nonafact was shown to be minimal.
Slovenian: V študijah farmakodinamike pri kuncih in morskih prašičkih so pokazali, da je trombogenost zdravila Nonafact minimalna.
English: Inhibitors
Slovenian: Inhibitorji
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: Vsaj 1 dan, dokler krvavitev, kot kaže bolečina, ni odpravljena ali celjenje doseženo.
English: It is important that the concentration of factor IX in your blood is checked regularly.
Slovenian: Pomembno je, da koncentracijo faktorja IX v vaši krvi redno preverjajo.
English: The specific activity of Nonafact is approximately 200 IU/mg protein.
Slovenian: Specifična aktivnost zdravila Nonafact je približno 200 i.e./mg beljakovin.
English: This also applies to unknown or emerging viruses or other pathogens.
Slovenian: To se nanaša tudi na neznane ali na novo pojavljajoče se viruse in druge patogene.
English: Pyrexia
Slovenian: Pireksija
English: Required units = body weight (kg) x desired factor IX rise (%) (IU/dl) x 0.9
Slovenian: Potrebne enote = telesna masa (kg) x želeno povišanje faktorja IX (%) (i.e./dl) x 0,9
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Slovenian: V primeru naslednjih krvavitev aktivnost faktorja IX ne sme pasti pod dano raven plazemske aktivnosti (v % normalnih vrednosti ali i.e./dl) v ustreznem obdobju.
English: Degree of bleeding / Type of surgical procedure
Slovenian: Stopnja krvavitve / Vrsta operacijskega posega
English: Remove the protective sheath from one end of a transfer needle and pierce the stopper of the vial containing water for injections.
Slovenian: Odstranite zaščitni tulec z enega konca igle za prenos in prebodite zaporko viale, ki vsebuje vodo za injekcije.
English: Contents of pack and other information
Slovenian: Vsebnost pakiranja in dodatne informacije
English: You will be closely monitored for any possible side effect during this treatment.
Slovenian: Med tem zdravljenjem vas bodo zaradi možnih neželenih učinkov skrbno opazovali.
English: If you have previously experienced hypersensitivity in response to the administration of blood or a blood product, Nonafact should only be administered when absolutely necessary (in life-threatening situations).
Slovenian: Če ste v preteklosti doživeli preobčutljivostne reakcije po dajanju krvi ali krvnih izdelkov, smete zdravilo Nonafact prejeti le, kadar je to nujno potrebno (v življenje ogrožajočih situacijah).
English: In addition, the powder will dissolve more readily if both vials are first allowed to reach room temperature (15°C - 25°C).
Slovenian: Poleg tega se bo prašek prej raztopil, če bosta obe viali najprej ogreti na sobno temperaturo (od 15 °C do 25 °C).
English: Factor IX level required (%) (IU/dl)
Slovenian: Potrebna raven faktorja IX (%) (i.e./dl)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, the Netherlands 12.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, Nizozemska.
English: Particularly with major surgery, it is important that the concentrations of factor IX in your blood are checked carefully before and after the operation.
Slovenian: Posebno ob večjih operacijah je pomembno, da vam koncentracijo faktorja IX v vaši krvi pred in po operaciji skrbno preverijo.
English: Nonafact is given to you by your doctor or nurse.
Slovenian: Zdravilo Nonafact vam bo dal zdravnik ali medicinska sestra.
English: In rare cases, Nonafact can give rise to a severe allergic reaction (anaphylactic shock).
Slovenian: V redkih primerih lahko zdravilo Nonafact povzroči hudo alergijsko reakcijo (anafilaktični šok).
English: Haemophilia B is a chronic disease, therefore lifelong treatment with a factor IX product may be necessary.
Slovenian: Hemofilija B je kronična bolezen, zato bo morda potrebno doživljenjsko zdravljenje s faktorjem IX.
English: Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Slovenian: Zato naj se faktor IX v času nosečnosti in dojenja uporablja le, kadar je to nujno indicirano.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11.
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: In theory, therefore, the use of Nonafact could generate antibodies to mouse protein.
Slovenian: Teoretično lahko torej uporaba zdravila Nonafact povzroči tvorbo protiteles proti mišjim beljakovinam.
English: It is a vitamin K-dependent coagulation factor and is synthesised in the liver.
Slovenian: Je od vitamina K odvisni koagulacijski faktor in se sintetizira v jetrih.
English: Nonafact should never be mixed with other medicinal products.
Slovenian: Zdravila Nonafact ne smemo nikoli mešati z drugimi zdravili.
English: Remove the empty vial and the transfer needle.
Slovenian: Odstranite prazno vialo in iglo za prenos.
English: Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway.
Slovenian: Faktor IX aktivirata faktor XIa v intrinzični poti koagulacije in kompleks faktorja VII/tkivnega faktorja v ekstrinzični poti.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
English: Contents:
Slovenian: Vsebina:
English: If you are unsure, you should discuss this with your doctor.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom.
English: There are no known interactions between Nonafact and other medicinal products.
Slovenian: Ni znanih interakcij med zdravilom Nonafact in drugimi zdravili.
English: If you need therapy for repressing antibodies (inhibitors) this should be taken care of in a haemophilia treating centre.
Slovenian: Če potrebujete zdravljenje za zaviranje protiteles (inhibitorje), bodo za to poskrbeli v centru za zdravljenje hemofilije.
English: 1 vial of powder for solution for injection 1 vial water for injections 5 ml 1 vial water for injections 10 ml
Slovenian: 1 viala praška za raztopino za injiciranje 1 viala vode za injekcije 5 ml 1 viala vode za injekcije 10 ml
English: The resulting solution is clear, colourless to light yellow and has a neutral pH.
Slovenian: Raztopina, ki jo dobite, mora biti bistra, brezbarvna do svetlo rumena, z nevtralnim pH.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness
Slovenian: Znotraj vsake razvrstitve glede na pogostost si neželeni učinki sledijo v padajočem vrstnem redu po resnosti.
English: White powder.
Slovenian: Bel prašek.
English: Paediatric population Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Slovenian: Pediatrična populacija Pri otrocih so pričakovani enaka pogostost, tip in resnost neželenih učinkov kot pri odraslih.
English: The safety and efficacy of Nonafact in previously untreated patients have not been established.
Slovenian: Varnost in učinkovitost zdravila Nonafact pri predhodno nezdravljenih bolnikih nista bili dokazani.
English: NL-1066 CX Amsterdam The Netherlands
Slovenian: NL-1066 CX Amsterdam Nizozemska
English: If you are administered 1 International Unit (IU) per kilogram of body weight, the concentration of factor IX in your blood will increase by 1.1 % of normal activity.
Slovenian: Če dobite 1 mednarodno enoto (i.e.) na kilogram telesne mase, se bo koncentracija faktorja IX v vaši krvi povišala za 1,1 % normalne aktivnosti.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerek, določen glede na telesno maso, bo morda pri bolnikih s prenizko ali prekomerno telesno maso treba prilagoditi.
English: Do not shake!
Slovenian: Ne stresajte!
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Slovenian: Ti vključujejo pozorno izbiranje dajalcev krvi in plazme, da bi tako izključili dajalce, ki so morebitni prenašalci okužb, in testiranje vsake donacije in vseh zbirov plazme na viruse in okužbe.
English: The use of Nonafact may also produce an increase in body temperature in rare cases.
Slovenian: Uporaba zdravila Nonafact lahko v redkih primerih povzroči tudi povišanje telesne temperature.
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: Na podlagi redkega pojavljanja hemofilije B pri ženskah, izkušenj v zvezi z uporabo faktorja IX med nosečnostjo in dojenjem ni.
English: By replacement therapy the plasma level of factor IX is increased, thereby enabling a temporary correction of the factor IX deficiency and correction of the bleeding tendencies.
Slovenian: Z nadomestnim zdravljenjem povišamo plazemske ravni faktorja IX in tako omogočimo začasno poboljšanje pomanjkanja faktorja IX in popravo tendence h krvavitvam.
English: If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an increased risk for coagulation complications.
Slovenian: Če imate obolenje jeter ali srca, ali so vas nedavno operirali, obstaja povečano tveganje za zaplete pri strjevanju krvi.
English: The solution should not be too cold when it is administered.
Slovenian: Raztopina ob dajanju ne sme biti prehladna.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Slovenian: Posebno v primeru večjih kirurških posegov je natančno spremljanje nadomestnega zdravljenja s pomočjo analize strjevanja krvi (aktivnosti faktorja IX v plazmi) obvezno.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Slovenian: Če je potreben pripomoček za centralni venski dostop (CVAD - Central Venous Access Device), je treba upoštevati tveganja za zaplete, povezane s tem pripomočkom, kot so npr. lokalne okužbe, bakteriemija in tromboza na mestu katetra.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Spodnja preglednica je skladna z razvrstitvijo organskih sistemov po sistemu MedDRA (organski sistemi in prednostni izrazi).
English: Remove the plastic cap from the vials.
Slovenian: Z vial odstranite plastični pokrovček.
English: The dose and duration of substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerek in trajanje nadomestnega zdravljenja sta odvisna od resnosti pomanjkanja faktorja IX, mesta in obsega krvavitve ter bolnikovega kliničnega stanja.
English: Contraindications
Slovenian: Kontraindikacije