natgillin/translations-raw huggingface dataset:
If this happens, Nonafact will not work effectively.
V takih primerih zdravilo Nonafact ni več učinkovito.
For the full list of all the side effects reported with Nonafact, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Nonafact, najdete v Navodilih za uporabo.
Nonafact should not be used in people who may be hypersensitive (allergic) to human coagulation factor IX or to any of the other ingredients, or to mouse proteins.
Zdravila Nonafact ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) človeški koagulacijski faktor IX ali katerokoli drugo sestavino ali na beljakovine miši.
The Committee for Medicinal Products for Human Use (CHMP) decided that Nonafact’ s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Nonafact pri zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo B večje od z njim povezanih tveganj.
They recommended that Nonafact be given marketing authorisation.
Zato je priporočil, da se za zdravilo Nonafact podeli dovoljenje za promet z zdravilom.
Other information about Nonafact:
Druge informacije o zdravilu Nonafact:
The European Commission granted a marketing authorisation valid throughout the European Union, for Nonafact to Sanquin, CLB, Products Division on 3 July 2001.
Evropska komisija je dovoljenje za promet z zdravilom Nonafact, veljavno po vsej Evropski uniji, odobrila družbi Sanquin, CLB, Products Division dne 3. julija 2001.
The full EPAR for Nonafact can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nonafact je na voljo tukaj.
Trade name
Zaščiteno ime
100IU/ ml
100 IE/ ml
Powder: vial (glass) Powder:
Prašek: viala (steklena) Topilo: viala (steklena)
500 IU Solvent: vial (glass) Solvent:
500 IE Topilo:
100 IU/ ml
100 IE/ ml
1000 IU Solvent: vial (glass) Solvent:
1000 IE Topilo:
10 ml (100 IU/ ml)
10 ml (100 IE/ ml)
Nonafact 100 IU/ ml powder and solvent for solution for injection.
Nonafact 100 i. e. / ml prašek in vehikel za raztopino za injciranje.
Nonafact contains 100 IU/ ml (500 IU/ 5ml or 1000 IU/ 10ml) human coagulation factor IX when reconstituted with 5 ml or 10 ml, respectively, of water for injections.
(500 i. e. / 5 ml ali 1000 i. e. / 10 ml) človeškega koagulacijskega faktorja IX, ko ga pripravimo s 5 ml oziroma 10 ml vode za injekcije.
Each vial contains 500 IU of human coagulation factor IX/ Each vial contains 1000 IU of human coagulation factor IX.
Vsaka viala vsebuje 500 i. e. človeškega koagulacijskega faktorja IX / Vsaka viala vsebuje 1000 i. e. človeškega koagulacijskega faktorja IX.
The potency (IU) is determined using a method equivalent to the test method described in the European Pharmacopoeia.
Jakost (i. e.) je določena z metodo, ekvivalentno testni metodi, opisani v Evropski farmakopeji.
The specific activity of Nonafact is at least 200 IU/ mg protein.
Specifična aktivnost Nonafacta je vsaj 200 i. e. / mg beljakovin.
This medicinal product contains 75mmol/ l sodium chloride per dose.
To zdravilo vsebuje 75 mmol/ l natrijevega klorida na odmerek.
To be taken into consideration by patients on a controlled sodium diet.
Slednje naj upoštevajo bolniki na nadzorovani natrijevi dieti.
White lyophilized powder and solvent for solution for injection.
Bel liofiliziran prašek in vehikel za raztopino za injiciranje.
Other determining factors are the site and extent of the haemorrhage and the patient’ s clinical condition.
Drugi odločujoči dejavniki so mesto in obseg krvavitve ter bolnikovo klinično stanje.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current International Standard for factor IX concentrate as approved by the WHO.
Število enot danega faktorja IX izražamo v internacionalnih enotah (i. e.), ki so povezane z veljavnim Internacionalnim standardom za koncentrat faktorja IX, kot ga je odobrila WHO.
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 izražamo kot odstotek (relativno glede na normalno človeško plazmo) ali v internacionalnih enotah (relativno glede na internacionalni standard za faktor IX v plazmi).
One International Unit (IU) of factor IX activity is related to the quantity of factor IX in the International Standard for factor II, VII, IX and X in human plasma (approved by the WHO) which approximates to the quantity of factor IX in one ml of normal human plasma.
Ena internacionalna enota (i. e.) aktivnosti faktorja IX je povezana s količino faktorja IX v Internacionalnem standardu za faktor II, VII, IX in X v človeški plazmi (odobrila WHO), ki je približek količini faktorja IX v enem ml normalne človeške plazme.
The calculation of the required dosage of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight raises the plasma factor IX activity by 1.1% of normal activity.
Izračun potrebnega odmerka faktorja IX temelji na empiričnih izsledkih, da 1 internacionalna enota (i. e.) faktorja IX na kg telesne mase poviša aktivnost plazemskega faktorja IX za 1, 1% normalne aktivnosti.
Required units = body weight (kg) x desired factor IX rise (%) (IU/ dl) x 0.9
Potrebne enote = telesna masa (kg) x želeno povišanje faktorja IX (%) (i. e. / dl) x 0, 9
2 The amount to be administered and the frequency of treatment should always be determined on the basis of clinical effectiveness in the individual patient.
Količino za dajanje in pogostnost zdravljenja moramo vedno določiti na podlagi klinične učinkovitosti pri posameznem bolniku.
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.
2 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.
Degree of haemorrhage / Type of surgical procedure Haemorrhage
Stopnja krvavitve / Vrsta
Factor IX level Frequency of doses (hours)/ Duration required (%) of therapy (days) (IU/ dl)
(ure) / Trajanje zdravljenja (dnevi)
Early haemarthrosis, muscle bleeding or oral bleeding
(%) (i. e. / dl) Krvavitev Zgodnji hemartros, krvavitev v mišico ali krvavitev v ustni votlini
20-40 Repeat every 24 hours.
Ponovite vsakih 24 ur.
30-60 Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved.
Ponovite infuzijo vsakih 24 ur od 3 do 4 dni ali več, dokler bolečina in akutna nezmožnost ne izzvenita.
Life threatening haemorrhages Surgery
Življenjsko nevarne krvavitve Operacija
60-100 Repeat infusion every 8 to 24 hours until threat is resolved.
Ponovite infuzijo vsakih 8 do 24 ur, dokler grožnja ne mine.
Minor including tooth extraction Major
Manjša vključno z ekstrakcijo zoba
30-60 Every 24 hours, at least 1 day, until healing is achieved.
Vsakih 24 ur, vsaj 1 dan, dokler ni doseženo celjenje.
80-100 Repeat infusion every 8-24 hours until adequate wound healing, then (pre- and therapy for at least another 7 days to postoperative) maintain a factor IX activity of 30% to 60% (IU/ dl).
pooperacijsko) vzdrževanje aktivnosti faktorja IX od 30% do 60% (i. e. / dl).
For long-term prophylaxis of haemorrhages in patients with severe haemophilia B, doses of 20 to 40 IU of factor IX per kilogram of body weight could be given at intervals of 3 to 4 days.
Za dolgoročno preprečevanje krvavitev in njenih posledic pri bolnikih s hudo hemofilijo B lahko dajemo odmerke 20 i. e. do 40 i. e. faktorja IX na kilogram telesne mase v intervalih 3 do 4 dni.
There are insufficient data to recommend the use of Nonafact in children less than 6 years of age.
Da bi priporočali uporabo Nonafacta pri otrocih, mlajših od 6 let, ni zadostnih podatkov.
Management of such patients should be directed by physicians with experience in the care of patients with haemophilia, see also 4.4.
Vodenje takih bolnikov naj usmerjajo zdravniki z izkušnjami pri oskrbi bolnikov s hemofilijo, glejte tudi poglavje 4. 4.
Dissolve the product as described at 6.6.
Zdravilo raztopite, kot je opisano v poglavju 6. 6.
It is recommended that the rate of administration should not exceed 2 ml/ min.
Priporočamo, da naj hitrost dajanja ne presega 2 ml/ min.
- Hypersensitivity to mouse proteins.
- Preobčutljivost za mišje beljakovine.
In each of these situations, the benefit of treatment with Nonafact should be weighed against the risk of these complications.
V vsaki od teh situacij moramo pretehtati korist zdravljenja z Nonafactom s tveganjem za te zaplete.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of virus.
Običajni ukrepi za preprečevanje okužb povezanih z uporabo zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro dajalcev, presejanje posameznih donacij in zbirov plazme na vsebnost točno določenih označevalcev okužb ter postopke pri izdelavi, namenjene inaktivaciji ali odstranjevanju virusov.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of plasma-derived factor IX concentrates.
Pri bolnikih, ki redno/ ponavljajoče prejemajo koncentrate iz plazme pridobljenega faktorja IX bi morali razmisliti o ustrezni obliki cepljenja (hepatitis A in B).
After repeated treatment with Nonafact, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Po večkratnem zdravljenju z Nonafactom moramo bolnike spremljati zaradi razvoja nevtralizirajočih protiteles (inhibitorjev), ki jih količinsko določimo z Bethesda enotami (BE) z uporabo ustreznega biološkega testiranja.
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 nevarnosti alergijskih reakcij pri dajanju koncentratov faktorja IX, morate na začetku faktor IX dati, glede na presojo lečečega zdravnika, pod zdravstvenim nadzorom in kjer lahko omogočite ustrezno zdravstveno oskrbo alergijskih reakcij.
4 4.5 Interactions with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
No interactions of Nonafact with other medicinal products are known.
Ni znanih medsebojnih interakcij med Nonafactom in drugimi zdravili.
Animal reproduction studies have not been conducted with factor IX.
4 Reproduktivnih študij pri živalih s faktorjem IX niso opravili.
Nonafact has no influence on the ability to drive or use machines.
Nonafact nima vpliva na sposobnost vožnje in upravljanja s stroji.
In some case, 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 v hudo anafilaksijo, pojavljale pa so se v tesni časovni povezavi z razvojem inhibitorjev faktorja IX (glejte tudi poglavje 4. 4).
In such cases, it is recommended that a specialised haemophilia centre be contracted.
V takih primerih priporočamo posvetovanje s specializiranim centrom za hemofilijo.
During clinical trials with Nonafact conducted in previously treated patients development of inhibitors was not reported.
V kliničnih preskušanjih Nonafacta, ki so jih opravili pri predhodno zdravljenih bolnikih, niso poročali o pojavu inhibitorjev.
There is no experience of the treatment of previously untreated patients with Nonafact.
Izkušenj pri zdravljenju predhodno še nezdravljenih bolnikov z Nonafactom ni.
Nonafact contains trace amounts (< 0.1 ng mouse IgG/ IU of factor IX) of the murine monoclonal antibody used in its purification.
Nonafact vsebuje monoklonska protitelesa glodalca v sledovih (< 0, 1 ng mišjega IgG/ i. e. faktorja IX), uporabljenih pri njegovem prečiščevanju.
In theory, therefore, the use of Nonafact could generate antibodies to mouse protein.
Teoretično lahko torej uporaba Nonafacta povzroči tvorbo protiteles proti mišjim beljakovinam.
For safety with respect to transmissible agents, see 4.4.
Za podatke o varnosti glede prenosljivih agensov glejte poglavje 4. 4.
No symptoms of overdose with human coagulation factor IX have been reported.
O simptomih prevelikega odmerjanja človeškega koagulacijskega faktorja IX niso poročali.
ATC code:
Krvni koagulacijski faktorji, koagulacijski faktor IX, Oznaka ATC:
Factor IX is a single chain glycoprotein with a molecular weight of about 68,000 Dalton.
Faktor IX je enoverižni glikoprotein z molekulsko maso približno 68. 000 Daltonov.
Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/ tissue factor complex in the extrinsic pathway.
Faktor IX aktivirata faktor XIa v intrinzični poti koagulacije in kompleks faktorja VII/ tkivnega faktorja v ekstrinzični poti.
Activated factor IX, in combination with activated factor VIII, activates factor X.
5 Aktivirani faktor IX v kombinaciji z aktiviranim faktorjem VIII aktivira faktor X.
This ultimately results in the conversion of prothrombin to thrombin.
To končno povzroči pretvorbo protrombina v trombin.
Haemophilia B is a gender-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 zaradi znižanih ravni faktorja IX in povzroča obsežne krvavitve v sklepe, mišice ali notranje organe, bodisi spontano, bodisi kot posledico nezgodne ali kirurške travme.
The in vivo increase in factor IX levels obtained with Nonafact is 1.1 IU/ dl per IU administered per kg body weight, which corresponds to an in vivo recovery of 49%.
In vivo povišanje ravni faktorja IX, ki ga dosežemo z Nonafactom, je 1, 1 i. e. / dl na število i. e., ki jih damo na kg telesne mase, kar ustreza in vivo nadomeščanju 49%.
Nonafact has a half-life of approximately 19 (17 – 21) hours.
Nonafact ima razpolovni čas približno 19 (od 17 do 21) ur.
In pharmacodynamic studies in rabbits and guinea pigs, the thrombogenicity of Nonafact was shown to be minimal.
V študijah farmakodinamike pri kuncih in morskih prašičkih so pokazali, da je trombogenost Nonafacta minimalna.
Sodium chloride Sucrose Histidine.
Natrijev klorid Saharoza Histidin.
In the absence of compability studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature of 21 °C.
Kemijska in fizikalna stabilnost med uporabo je dokazana za 3 ure pri temperaturi 21 °C.
Store in a refrigerator (at 2°C – 8°C).
Shranjujte v hladilniku (pri temperaturi med 2 °C in 8 °C).
500 IU: one vial (glass type I) of powder + one vial (glass type I) of 5 ml solvent with stoppers (bromobutyl).
500 i. e.: ena viala (steklo tipa I) praška + ena viala (steklo tipa I) 5 ml vehikla z zaporkama (bromobutil).
1000 IU: one vial (glass type I) of powder + one vial (glass type I) of 10 ml solvent with stoppers (bromobutyl).
6 1000 i. e.: ena viala (steklo tipa I) praška + ena viala (steklo tipa I) 10 ml vehikla z zaporkama (bromobutil).
6.6 Instructions for use/ and handling, and disposal
6. 6 Navodila za pripravo in ravnanje z zdravilom ter odlaganje
Disinfect the surface of the stoppers of both vials with a gauze soaked in 70% alcohol.
Razkužite površino zapork obeh vial z gazo, prepojeno s 70% alkoholom.
Swirl the vial gently to completely dissolve the powder within 5 minutes.
Nežno vrtite vialo, da popolnoma raztopite prašek v 5. minutah.
The resulting solution is clear, colourless to light yellow and has a neutral pH.
Raztopina, ki jo dobite, mora biti bistra, brezbarvna do svetlo rumena z nevtralnim pH.
Immediately before administration, the solution should be inspected visually for undissolved particulate matter and discoloration.
Neposredno pred dajanjem je treba pregledati videz raztopine, da ne vsebuje neraztopljenih trdnih delcev in obarvanja.
The solution should be clear and colourless to light yellow.
Raztopina mora biti bistra in brezbarvna do svetlo rumena.
Do not use solutions that are discoloured or have deposits.
Drugače obarvanih raztopin ali raztopin z usedlinami ne uporabljajte.
Sanquin Plesmanlaan 125 NL-1066 CX Amsterdam The Netherlands
Sanquin Plesmanlaan 125 NL- 1066 CX Amsterdam Nizozemska
EU/ 1/ 01/ 186/ 001 (500 IU) EU/ 1/ 01/ 186/ 002 (1000 IU)
EU/ 1/ 01/ 186/ 001 (500 i. e.) EU/ 1/ 01/ 186/ 002 (1000 i. e.)
3 July 2001 Renewal of authorisation:
3. julij 2001 Podaljšanje dovoljenja za promet:
7 10.
7 DODATEK II
DATE OF REVISION OF TEXT
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
CONDITIONS OF THE MARKETING AUTHORISATION
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Stichting Sanquin Bloedvoorziening, Plesmanlaan 125 1066 CX Amsterdam The Netherlands
Stichting Sanquin Bloedvoorziening Plesmanlaan 125 1066 CX Amsterdam Nizozemska
Medicinal product subject to restricted medical prescription (See Annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Poglavje I:
Summary of Product Characteristics, 4.2)
Povzetek glavnih značilnosti zdravila, 4. 2)
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s 114. členom Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
LABELLING
11 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
ŠKATLA Z VIALO PRAŠKA 500 i. e.
BOX VIAL OF POWDER 500 IU BOX VIAL OF POWDER 1000 IU
ŠKATLA Z VIALO PRAŠKA 1000 i. e.
Nonafact 100 IU/ ml powder and solvent for solution for injection Human coagulation factor IX
Nonafact 100 i. e. / ml prašek in vehikel za raztopino za injiciranje. človeški koagulacijski faktor IX
500 IU human coagulation factor IX (100 IU/ ml after reconstitution).
500 i. e. človeškega koagulacijskega faktorja IX (100 i. e. / ml po pripravi).
1000 IU human coagulation factor IX (100 IU/ ml after reconstitution).
1000 i. e. človeškega koagulacijskega faktorja IX (100 i. e. / ml po pripravi).
contains: sodium chloride, histidine and sucrose
Vsebuje: natrijev klorid, histidin in saharozo.
solvent: water for injections
Vehikel: voda za injekcije.
powder and solvent for solution for injection
Prašek in vehikel za raztopino za injiciranje.
contents:
Vsebina:
reconstitute with 5 ml of water for injections; reconstitute with 10 ml of water for injections; the product should be used immediately; single dose administration only
Samo za dajanje enkratnega odmerka.
for intravenous use
Za intravensko uporabo.
read the package leaflet before use
Pred uporabo preberite priloženo navodilo.
keep out of the reach and sight of children
Zdravilo shranjujte nedosegljivo otrokom!
do not use if the solution is not totally clear or if the powder is not totally reconstituted
Ne uporabite, če raztopina ni popolnoma bistra ali če prašek ni popolnoma raztopljen.
EXP:
"EXP":
store in a refrigerator (at 2°C – 8°C), do not freeze keep the container in the outer carton, in order to protect from light
Za zagotovitev zaščito pred svetlobo vsebnik shranjujte v zunanji ovojnini.
Sanquin, Plesmanlaan 125, NL-1066 CX Amsterdam, the Netherlands
Sanquin, Plesmanlaan 125, NL- 1066 CX Amsterdam, Nizozemska.
batch:
Serija:
medicinal product subject to medical prescription
Izdaja zdravila je le na recept.
INFORMATION IN BRAIILE
PODATKI V BRAILOVI PISAVI
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL OF POWDER 500 IU VIAL OF POWDER 1000 IU
VIALA PRAŠKA 1000 i. e.
Nonafact 100 IU/ ml powder for solution for injection Human coagulation factor IX for intravenous use
Človeški koagulacijski faktor IX Za intravensko uporabo.
reconstitute with 5 ml of water for injections; reconstitute with 10 ml of water for injections; administer immediately; read the package leaflet before use
Pred uporabo preberite navodila za uporabo.
500 IU (100 IU/ ml after reconstitution) 1 vial:
1 viala:
1000 IU (100 IU/ ml after reconstitution)
(100 i. e. / ml po rekonstituciji).
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
for reconstitution of Nonafact read the package leaflet before use
Pred uporabo preberite navodilo za uporabo.
PACKAGE LEAFLET
16 NAVODILO ZA UPORABO:
Nonafact 100 IU/ ml Powder and solvent for solution for injection Human coagulation factor IX
Nonafact 100 i. e. / ml prašek in vehikel za raztopino za injiciranje. človeški koagulacijski faktor IX
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Pred začetkom uporabe natančno preberite navodilo. • Navodilo shranite.
You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Powder The active substance is human coagulation factor IX.
Prašek Zdravilna učinkovina je človeški koagulacijski faktor IX.
The product contains 100 International Units (IU) per ml (500 IU/ 5 ml or 1000 IU/ 10 ml) human coagulation factor IX when reconstituted with 5 ml or 10 ml, respectively, of water for injections.
Izdelek vsebuje 100 internacionalnih enot (i. e.) na ml (500 i. e. / 5 ml ali 1000 i. e. / 10 ml) človeškega koagulacijskega faktorja IX, ko ga rekonstituiramo s 5 ml oziroma 10 ml vode za injekcije.
Solvent Water for injections.
Vehikel Voda za injekcije.
What Nonafact is and what it is used for 2.
Kaj je Nonafact in za kaj ga uporabljamo 2.
Before you use Nonafact 3.
Kaj morate vedeti, preden boste uporabili Nonafact 3.
How to use Nonafact 4.
Kako uporabljati Nonafact 4.
How to store Nonafact 6.
Shranjevanje Nonafacta 6.
WHAT NONAFACT IS AND WHAT IT IS USED FOR
KAJ JE NONAFACT IN ZA KAJ GA UPORABLJAMO
Nonafact can be administered to prevent and treat bleeding in patients suffering from haemophilia B (a congenital lack of active factor IX).
Nonafact lahko dajemo za preprečevanje in zdravljenje krvavitve pri bolnikih s hemofilijo B (prirojenim pomanjkanjem aktivnega faktorja IX).
The administration of Nonafact can compensate for this deficiency.
Uporaba Nonafacta lahko nadomesti to pomanjkanje.
BEFORE YOU USE NONAFACT
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI NONAFACT
Do not use Nonafact:
Ne uporabljajte Nonafacta:
- if you are hypersensitive (allergic) to the active substance, human coagulation factor IX.
- če ste preobčutljivi za (alergični na) zdravilno učinkovino, človeški koagulacijski faktor IX.
- if you are hypersensitive (allergic) to any of the other ingredients or to mouse proteins.
- če ste preobčutljivi za (alergični na) katerokoli sestavino zdravila ali mišje beljakovine.
Take special care with Nonafact:
Bodite posebno pozorni pri uporabi Nonafacta: