natgillin/translations-raw huggingface dataset:
Factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Faktor IX smete med nosečnostjo in dojenjem uporabljati le, če obstaja jasna indikacija.
Factor IX is a normal constituent of human blood necessary for effective blood clotting.
Faktor IX je normalna sestavina človeške krvi in je potreben za učinkovito strjevanje krvi.
Twenty procedures were major including 13 orthopaedic and 3 dental surgeries.
Dvajset posegov je bilo večjih, vključno s 13 ortopedskimi in 3 zobozdravstvenimi kirurškimi posegi.
Paediatric population The listed warnings and precautions apply both to adults and children.
Pediatrična populacija Navedena opozorila in previdnostni ukrepi veljajo tako za odrasle bolnike kot za otroke.
Place the vials on a flat clean surface.
Viali položite na ravno, čisto površino.
See tables below.
Glejte spodnje preglednice.
Talk to your doctor immediately if your bleeding does not stop as expected or if you experience a significant increase in your usage of RIXUBIS in order to control a bleed.
Nemudoma se posvetujte s svojim zdravnikom, če se krvavitev ne ustavi po pričakovanjih ali če opazite bistveno povečanje porabe zdravila RIXUBIS, ko želite obvladati krvavitev.
- Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
- Pripomočka BAXJECT II ne uporabite, če sta njegov sistem sterilne bariere ali njegova ovojnina poškodovana ali če ima pripomoček znake okvare.
Treatment was individualised based on the severity, cause and site of bleed.
Zdravljenje je bilo individualno prilagojeno glede na resnost, vzrok in mesto krvavitve.
Minor surgery including tooth extraction
Kirurški poseg Manjši, vključno z izdrtjem zoba
The subjects received either of the products as a single intravenous infusion.
Preiskovanci so prejeli eno od zdravil kot eno intravensko infuzijo.
The specific activity of RIXUBIS is approximately 200-390 IU/mg protein.
Specifična aktivnost zdravila RIXUBIS je približno 200-390 i.e./mg beljakovin.
Every 24 hours, at least 1 day, until healing is achieved.
Na vsakih 24 ur najmanj 1 dan, do zacelitve.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Zato je treba bolnike, pri katerih se pojavi alergijska reakcija, pregledati za prisotnost zaviralca.
In some cases, depending upon the individual patient´s pharmacokinetics, age, bleeding phenotype and physical activity, shorter dosage intervals or higher doses may be necessary.
V nekaterih primerih, odvisno od bolnikove farmakokinetike, starosti, fenotipa krvavitve in telesne dejavnosti, so lahko potrebni krajši razmiki med odmerki ali večji odmerki.
Repeat infusion every 8 to 24 hours until threat is resolved.
Infuzijo ponavljajte na vsakih 8 do 24 ur, dokler ne mine ogroženost.
If you stop using RIXUBIS Do not stop using RIXUBIS without consulting your doctor.
Če ste prenehali uporabljati zdravilo RIXUBIS Uporabe zdravila RIXUBIS ne smete prekiniti brez posvetovanja s svojim zdravnikom.
17 procedures, including 10 dental extractions, were considered minor.
Sedemnajst posegov, vključno z 10 izdrtji zoba, je bilo manjših.
No investigations on carcinogenicity, fertility impairment, and fetal development have been conducted.
Raziskave karcinogenosti, okvar plodnosti in učinkov na razvoj ploda niso bile opravljene.
The per-protocol efficacy analysis includes 37 surgeries performed in 27 patients between 17 and 57 years of age undergoing major or minor surgical, dental or other surgical invasive procedures.
Analiza učinkovitosti po protokolu je vključevala 37 kirurških posegov pri 27 bolnikih, starih od 17 do 57 let, pri katerih so opravili večje ali manjše kirurške posege, zobozdravstvene ali druge kirurške invazivne posege.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
V takšnih primerih je priporočljivo, da se obrnete na specializirani center za hemofilijo.
Thrombin then converts fibrinogen into fibrin and a clot is formed.
Trombin potem pretvori fibrinogen v fibrin in tako nastane krvni strdek.
The effects of higher than recommended doses of RIXUBIS have not been characterised.
Učinki odmerkov zdravila RIXUBIS, ki so večji od priporočenih, niso bili raziskani.
RIXUBIS is indicated in patients of all age groups.
Zdravilo RIXUBIS je indicirano za bolnike vseh starostnih skupin.
It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line.
Pridobljen je s tehnologijo rekombinantne DNA v celični liniji jajčnika kitajskega hrčka (CHO).
RIXUBIS Initial cross-over study (N=25)
RIXUBIS Prvotna navzkrižna študija (N = 25)
If you injected more RIXUBIS than recommended, tell your doctor as soon as possible.
Če ste injicirali večji odmerek zdravila RIXUBIS, kot je priporočeno, se čimprej posvetujte z zdravnikom.
Use the reconstituted solution immediately.
Rekonstituirano raztopino uporabite nemudoma.
What RIXUBIS is and what it is used for
Kaj je zdravilo RIXUBIS in za kaj ga uporabljamo
Fifty-six of these PTPs who received RIXUBIS for a minimum of 3 months were included in the efficacy evaluation for prophylaxis.
Šestinpetdeset teh predhodno zdravljenih bolnikov, ki so prejemali zdravilo RIXUBIS vsaj 3 mesece, je bilo vključenih v oceno učinkovitosti profilakse.
Dose based on bodyweight may require adjustment in underweight or overweight patients.
Odmerek, ki temelji na telesni masi, je morda treba prilagoditi pri prelahkih in pretežkih bolnikih.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvjalca, odgovornega za sprostitev zadevne serije.
Other medicines and RIXUBIS
Druga zdravila in zdravilo RIXUBIS
Store below 30°C.
Shranjujte pri temperaturi do 30 °C.
If the product is stored in a refrigerator, take both the RIXUBIS powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 30°C).
Če je zdravilo shranjeno v hladilniku, iz hladilnika vzemite vialo praška RIXUBIS in vialo vehikla RIXUBIS in počakajte, da se ogrejeta na sobno temperaturo (med 15 °C in 30 °C).
Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Faktor IX je enoverižni glikoprotein z molekulsko maso približno 68.000 daltonov.
Reconstitution and administration
Rekonstitucija in uporaba
Common side effects (may affect up to 1 in 10 patients) - altered taste - pain in limbs.
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov) - spremenjeno okušanje, - bolečine v okončinah.
No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
O medsebojnem delovanju pripravkov humanega koagulacijskega faktorja IX (rDNA) z drugimi zdravili niso poročali.
Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Pakiranje pripomočka BAXJECT II odprite tako, da odlepite papirnati del ovojnine, ne da bi se dotaknili notranjosti (slika a).
Incorrect dosing can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Nepravilno odmerjanje je lahko posledica adsorbcije humanega koagulacijskega faktorja IX na notranje površine infuzijske opreme.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega vidika je treba razredčeno zdravilo nemudoma uporabiti, razen če način rekonstitucije izključi tveganje mikrobne kontaminacije.
Repeat infusion every 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Infuzijo ponavljajte na vsakih 24 ur 3 do 4 dni ali več, dokler ne izgine bolečina in preneha akutna onesposobljenost.
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.
Zlasti pri velikih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja z analizo koagulacije (aktivnosti faktorja IX v plazmi).
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).
V nekaterih primerih so te reakcije napredovale do hude anafilaksije in so nastopile v časovni povezavi s pojavom zaviralcev faktorja IX (glejte tudi poglavje 4.4).
The product contains traces of hamster proteins.
Zdravilo vsebuje sledove proteinov hrčka.
If you forget to use RIXUBIS
Če ste pozabili uporabiti zdravilo RIXUBIS
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.
Zaradi potencialnega tveganja za nastanek trombotičnih zapletov je potrebno klinično opazovanje zgodnjih znakov trombotične in porabnostne koagulopatije z ustreznimi biološkimi testi, kadar dajemo to zdravilo bolnikom z jetrno boleznijo, bolnikom po operaciji, novorojenčkom ali bolnikom s tveganjem za nastanek trombotičnih zapletov ali DIK.
The recommended dose range for paediatric patients less than 12 years is 40 to 80 IU/kg at intervals of 3 to 4 days.
Razpon priporočenih odmerkov za pediatrične bolnike, mlajše od 12 let, je 40 do 80 i.e./kg v presledkih po 3 do 4 dni.
The European Medicines Agency has waived the obligation to submit the results of studies with RIXUBIS in previously untreated patients in the treatment and prophylaxis of bleeding in haemophilia B (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom RIXUBIS za predhodno nezdravljene bolnike za zdravljenje in profilakso pri krvavitvah pri hemofiliji B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Subjects were randomised to one of two blood sampling sequences to reduce the burden of frequent blood draws on the individual subjects.
Preiskovanci so bili randomizirani v eno od dveh zaporedij vzorčenja krvi, da se zmanjša obremenitev posameznega preiskovanca s pogostim jemanjem krvi.
Perioperative management:
Perioperativna uporaba:
What you need to know before you use RIXUBIS
Kaj morate vedeti, preden boste uporabili zdravilo RIXUBIS
Whenever possible, please record the name of the product and the batch number every time you use RIXUBIS (e.g. in your diary) to keep track of the products and product batches you have used.
Če je možno, vsakič ko uporabite zdravilo RIXUBIS, zabeležite ime in serijo zdravila (npr. v svoj dnevnik), da zagotovite sledljivost uporabljenih zdravil in njihovih serij.
One International Unit of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Ena mednarodna enota aktivnosti faktorja IX ustreza količini faktorja IX v enem ml normalne človeške plazme.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvjalca biološke zdravilne učinkovine
Patients aged 12 to 17 years of age:
Bolniki, stari od 12 do 17 let:
Manufacturer
Proizvjalec
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Zdravljenje je treba uvesti pod nadzorom zdravnika, izkušenega v zdravljenju hemofilije.
No interactions of RIXUBIS with other medicines are known.
Medsebojno delovanje zdravila RIXUBIS z drugimi zdravili ni znano.
A total of 26 bleeding episodes were treated with RIXUBIS, of which 23 bleeds were due to injury, 2 spontaneous and 1 of unknown origin.
Z zdravilom RIXUBIS je bilo zdravljenih skupno 26 epizod krvavitev, od katerih je bilo 23 krvavitev zaradi poškodbe, 2 sta bili spontani in 1 neznanega izvora.
The data demonstrate that the incremental recovery is consistent over time across all paediatric age groups.
Podatki kažejo, da je porast aktivnosti faktorja IX po odmerku stalen skozi čas v vseh pediatričnih starostnih skupinah.
This should be taken into consideration if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
Required units
Potrebno št. enot
An additional 14 PTPs received RIXUBIS for the treatment of bleeding episodes only.
Drugih 14 predhodno zdravljenih bolnikov je prejemalo zdravilo RIXUBIS samo za zdravljenje epizod krvavitev.
Volume of distribution at steady state
Porazdelitveni volumen v stanju dinamičnega ravnovesja
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.
Če je potreben centralni venski pristop (CVAD), se morate zavedati tveganja zapletov, povezanih s CVAD, med katere sodijo lokalne okužbe, bakteriemija in tromboza na mestu katetra.
If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications.
Obvestite zdravnika, če imate bolezen jeter ali srca ali ste pred kratkim prestali večji kirurški poseg, saj imate povečano tveganje za zaplete s strjevanjem krvi (koagulacijo).
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravilo ne uporabi takoj, je za trajanje hrambe med uporabo in pogoje pred uporabo odgovoren uporabnik.
Problems from exaggerated blood clotting (thromboembolic episodes) have not been observed with this product, but may occur with any factor IX products.
Težav s čezmernim strjevanjem krvi (tromboembolični dogodki) pri uporabi tega zdravila niso ugotovili, vendar se lahko pojavijo pri katerem koli pripravku faktorja IX.
The following table can be used to guide dosing in bleeding episodes and surgery:
Naslednjo preglednico lahko uporabimo kot vodilo odmerjanja pri epizodah krvavitev in kirurških posegih:
What RIXUBIS is and what it is used for What you need to know before you use RIXUBIS How to use RIXUBIS
Kaj je zdravilo RIXUBIS in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo RIXUBIS Kako uporabljati zdravilo RIXUBIS Možni neželeni učinki
• one BAXJECT II (needle-less reconstitution device)
• en pripomoček BAXJECT II (brezigelni pripomoček za rekonstitucijo).
Inject intravenously.
Zdravilo injicirajte intravensko.
Repeat infusion every 8 to 24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dl).
Infuzijo ponavljajte na vsakih 8 do 24 ur, dokler se rana zadostno ne zapre, nato nadaljujte s terapijo še najmanj 7 dni za vzdrževanje aktivnosti faktorja IX med 30 % in 60 %.
Continuous infusion Do not administer RIXUBIS by continuous infusion.
Kontinuirana infuzija Zdravila RIXUBIS ne dajajte s kontinuirano infuzijo.
RIXUBIS was not thrombogenic at a dose of 750 IU/kg in a rabbit stasis model (Wessler-Test).
Zdravilo RIXUBIS ni bilo trombogeno v odmerku 750 i.e./kg v modelu staze pri kuncih (Wesslerjev preskus).
RIXUBIS is used for the treatment and prevention of bleeding in patients with haemophilia B of all age groups.
Zdravilo RIXUBIS se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B vseh starostnih skupin.
Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
Rekonstituirano raztopino povlecite v brizgo tako, da počasi povlečete bat (slika e).
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 za nastanek alergijskih reakcij s koncentrati faktorja IX je treba dajanje začetnih odmerkov faktorja IX po presoji lečečega zdravnika izvajati pod zdravniškim nadzorom, kjer lahko zagotovimo ustrezno medicinsko oskrbo v primeru nastopa alergijskih reakcij.
In each of these situations, the benefit of treatment with RIXUBIS should be weighed against the risk of these complications.
V vsakem od teh primerov moramo pretehtati razmerje koristi in tveganja za nastanek zapletov pri zdravljenju z zdravilom RIXUBIS.
Subjects in the on-demand cohort had to have at least 12 documented bleeding episodes requiring treatment within 12 months prior to enrollment.
Preiskovanci v kohorti z zdravljenjem po potrebi so morali imeti v 12 mesecih pred vključitvijo vsaj 12 zabeleženih epizod krvavitev, ki so zahtevale zdravljenje.
Do not use RIXUBIS if the solution is not clear and colourless.
Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra in brezbarvna.
Do not refrigerate the preparation after reconstitution.
Pripravka po rekonstituciji ne shranjujte v hladilniku.
Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Aktivirani faktor IX in aktivirani faktor VIII skupaj aktivirata faktor X, ta pa pretvori protrombin v trombin.
Breast-feeding It is unknown whether Factor IX/metabolites are excreted in human milk.
Dojenje Ni znano, ali se faktor IX/presnovki izločajo v materino mleko.
Known allergic reaction to hamster protein.
Dokazana alergijska reakcija na proteine hrčka.
As for all patients, dose selection for an elderly patient should be individualised.
Kot pri vseh bolnikih je treba odmerjanje za starostnike individualno prilagoditi.
During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Med potekom zdravljenja je priporočljivo ustrezno določanje ravni faktorja IX, kot vodilo za določanje odmerka in pogostnosti ponavljajočih se infuzij.
Area under the plasma concentration-time curve from time 0 to infinity.
Ploščina pod krivuljo odvisnosti plazemske koncentracije od časa od 0 do neskončnosti.
The RIXUBIS dose range in the repeat pharmacokinetics study was 64.48 to 79.18 IU/kg (n=23).
Razpon odmerkov zdravila RIXUBIS v študiji ponavljajoče farmakokinetike je bil od 64,48 do 79,18 i.e./kg (n = 23).
However, no data are available on previously untreated patients as only previously treated patients have been enrolled in the clinical studies; no immunogenicity investigation on inhibitor development was therefore made in this at risk population.
Vendar ni razpoložljivih podatkov o predhodno nezdravljenih bolnikih, ker so bili v klinične študije vključeni le predhodno zdravljeni bolniki.
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).
Aktivnost faktorja IX v plazmi je izražena v odstotkih (glede na običajno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor IX v plazmi).
These may include heart attack, blood clots in the veins or blood clots in the lung.
Med te dogodke sodijo srčni infarkt, krvni strdki v venah ali krvni strdki v pljučih.
RIXUBIS has no influence on the ability to drive and use machines.
Zdravilo RIXUBIS nima vpliva na sposobnost vožnje in upravljanja s stroji.
A total of 249 bleeding episodes were treated with RIXUBIS, of which 197 were joint bleeds and 52 non-joint bleeds (soft tissue, muscle, body cavity, intracranial and other).
Z zdravilom RIXUBIS je bilo zdravljenih skupno 249 epizod krvavitev, od katerih je bilo 197 krvavitev v sklepe in 52 drugačnih krvavitev (mehko tkivo, mišice, telesna votlina, intrakranialno in drugo).
19 bleeds were non-joint (soft tissue, muscle, body cavity, intracranial and other) and 7 were joint bleeds of which 1 was a bleed into a target joint.
19 krvavitev je bilo izvensklepnih (mehko tkivo, mišice, telesna votlina, interkranialno in drugo), 7 krvavitev pa v sklepe, od katerih je bila 1 krvavitev v ciljni sklep.
Haemostasis was maintained throughout the study duration.
Tekom študije je bila hemostaza ohranjena.
RIXUBIS Repeat Evaluation (N=23)
RIXUBIS Ponovna ocena (N = 23)
AUC0-72h (IU.hr/dL)
AUC0-72 h (i.e.h/dl)
If you are not sure check with your doctor.
Če ste negotovi, se posvetujte z zdravnikom.
The median ABR was 2.0, for spontaneous bleeds 0.0 and for joint bleeds 0.0.
Mediana vrednosti ABR je bila 2,0, za spontane krvavitve 0,0 in za krvavitve v sklepe 0,0.
Hypersensitivity a)
Bolezni imunskega sistema preobčutljivost a)
Do not use this medicine after the expiry date which is stated on the outer box and vial label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
RIXUBIS should be administered using a rate that ensures the comfort of the patient, up to a maximum of 10 ml/min.
Zdravilo RIXUBIS je treba dajati s hitrostjo, ki zagotavlja ugodje bolnika, in sicer največ 10 ml/min.
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.
Hemofilija B je spolno vezana dedna motnja strjevanja krvi, ki nastane zaradi zmanjšane koncentracije faktorja IX in povzroči obilne krvavitve v sklepe, mišice ali notranje organe, bodisi spontane ali kot posledica nezgode ali kirurške travme.
• one vial of RIXUBIS 250, 500, 1000, 2000 or 3000 IU powder in a glass vial with a rubber stopper
• ena viala praška RIXUBIS 250, 500, 1000, 2000 ali 3000 i.e. v stekleni viali z zamaškom iz gume,
Do not use solutions that are cloudy or have deposits.
Ne uporabljajte raztopin, ki so motne ali vsebujejo usedlino.
The risk for developing inhibitors is highest in patients who have not been treated with a factor IX replacement medicine before or in the early phases of treatment, i.e. for small children.
Tveganje za pojav zaviralcev je največje pri bolnikih, ki se še niso zdravili z zdravili za nadomeščanje faktorja IX, in pri bolnikih v zgodnjih fazah zdravljenja, tj. majhnih otrocih.
The mean treatment duration in the on-demand cohort was 3.5±1.00 months (median 3.4, ranging from 1.2 to 5.1 months), the mean total annualised bleeding rate (ABR) was 33.9±17.37 with a median of 27.0, ranging from 12.9 to 73.1.
Povprečno trajanje zdravljenja v kohorti z zdravljenjem po potrebi je bilo 3,5±1,00 mesecev (mediana 3,4, razpon od 1,2 do 5,1 mesecev), povprečna skupna letna stopnja krvavitev (ABR, annual bleeding rate) je bila 33,9±17,37 z mediano 27,0 in razponom od 12,9 do 73,1.
• one vial of 5 ml sterilised water for injections in a glass vial with a rubber stopper
• ena viala s 5 ml sterilizirane vode za injekcije v stekleni viali z zamaškom iz gume,
Driving and using machines RIXUBIS has no influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo RIXUBIS nima vpliva na sposobnost vožnje in upravljanja s stroji.
Animal reproduction studies have not been conducted with factor IX.
Študije vpliva faktorja IX na razmnoževanje pri živalih niso bile opravljene.
On demand treatment:
Zdravljenje po potrebi:
The recommended initial loading dose of RIXUBIS was to ensure that during surgery, factor IX activity levels of 80-100% for major surgeries and 30-60% for minor surgeries were maintained.
S priporočenim začetnim polnilnim odmerkom zdravila RIXUBIS so zagotovili, da so se med kirurškim posegom ohranjale ravni aktivnosti faktorja IX med 80 in 100 % za večje kirurške posege in med 30 in 60 % za manjše kirurške posege.
The vacuum will draw the solvent into the RIXUBIS vial (Fig. c).
Vakuum bo posesal vehikel v vialo s praškom RIXUBIS (slika c).