natgillin/translations-raw huggingface dataset:
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
0 56 33, 7 31, 5 10, 31 15, 3... 62, 2 6 53 31, 8 31, 0 9, 04 15, 3... 56, 7 12 50 31, 3 30, 5 8, 75 16, 2... 53, 1 18 47 30, 7 28, 9 9, 24 12, 6... 62, 1 24 47 31, 0 30, 6 8, 80 16, 2... 59, 4
FIX increase (IU/ dl per IU/ kg)
FIX taseme tõus (RÜ/ dl RÜ/ kg kohta)
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 56 0, 75 0, 70 0, 23 0, 34... 1, 38 6 53 0, 71 0, 69 0, 20 0, 34... 1, 26 12 50 0, 70 0, 68 0, 19 0, 36... 1, 18 18 47 0, 68 0, 64 0, 21 0, 28... 1, 38 24 47 0, 69 0, 68 0, 20 0, 36... 1, 32
Elimination half-life (hrs)
Eliminatsiooni poolväärtusaeg (tundides)
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
0 56 19, 3 19, 1 4, 97 11, 1... 36, 4 6 53 19, 8 18, 2 6, 26 9, 6... 38, 2 12 49 18, 5 16, 6 5, 89 10, 6... 33, 7 18 46 18, 9 16, 3 7, 02 10, 7... 38, 3 24 45 18, 9 17, 3 6, 84 10, 9... 42, 2
AUC0- ∞ (IU × hr/ dl) Half-life
AUC0- ∞ (RÜ × tunnis/ 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
0 56 619, 8 605, 2 155, 7 366, 5... 1072, 6 6 53 579, 8 562, 2 146, 1 330, 9... 900, 1 12 49 575, 7 566, 0 151, 0 290, 3... 1080, 8 18 46 561, 8 560, 9 155, 6 254, 5... 940, 8 24 45 577, 6 551, 7 154, 7 284, 1... 1045, 4
Initial Phase (hrs)
algfaas (tundides)
6 12 18 24
6 12 18 24
52 48 44 43
52 48 44 43
2.3 2.2 2.0 1.8
2, 3 2, 2 2, 0 1, 8
1.0 1.2 1.3 0.78
1, 0 1, 2 1, 3 0, 78
2.62 2.70 1.94 2.07
2, 62 2, 70 1, 94 2, 07
0.12-9.98 0.13-14.34 0.13-6.21 0.11-7.43
0, 12... 9, 98 0, 13... 14, 34 0, 13... 6, 21 0, 11... 7, 43
1.5,3.0 1.5,3.0 1.4,2.6 1.1,2.4
1, 5; 3, 0 1, 5; 3, 0 1, 4; 2, 6 1, 1; 2, 4
Clearance (ml/ hr/ kg)
Kliirens (ml/ tunnis/ kg)
8.4 9.2 9.3 9.6 9.2
8, 4 9, 2 9, 3 9, 6 9, 2
8.2 8.9 8.8 8.9 9.1
8, 2 8, 9 8, 8 8, 9 9, 1
2.01 2.48 2.53 2.85 2.40
2, 01 2, 48 2, 53 2, 85 2, 40
4.66-13.64 5.55-15.11 4.63-17.22 5.31-19.65 4.78-17.60
4, 66... 13, 64 5, 55... 15, 11 4, 63... 17, 22 5, 31... 19, 65 4, 78... 17, 60
7.86,8.94 8.53,9.89 8.56,10.01 8.78,10.47 8.52,9.96
7, 86; 8, 94 8, 53; 9, 89 8, 56; 10, 01 8, 78; 10, 47 8, 52; 9, 96
MRT (hrs)
MRT (tundides)
26.0 25.6 24.6 24.7 25.1
26, 0 25, 6 24, 6 24, 7 25, 1
25.8 25.3 22.2 22.7 23.9
25, 8 25, 3 22, 2 22, 7 23, 9
6.07 5.68 6.47 7.40 6.94
6, 07 5, 68 6, 47 7, 40 6, 94
15.81-46.09 13.44-42.26 14.83-38.75 15.30-50.75 15.65-47.52
15, 81... 46, 09 13, 44... 42, 26 14, 83... 38, 75 15, 30... 50, 75 15, 65... 47, 52
24.35,27.60 24.01,27.15 22.75,26.47 22.55,26.94 23.00,27.17
24, 35; 27, 60 24, 01; 27, 15 22, 75; 26, 47 22, 55; 26, 94 23, 00; 27, 17
Data exclude those collected from one patient after evidence of inhibitor development was observed at 9 months.
Andmetest on välja jäetud ühe patsiendi andmed, kellel inhibiitorite teke leiti 9. kuul.
AUC0 - ∞ = Area Under the Curve MRT = Mean Residence Time SD = Standard Deviation CI = Confidence Interval
AUC0 - ∞ = kontsentratsioonikõvera alune pindala MRT = keskmine residentsusaeg SH = standardhälve
A 28% lower recovery of recombinant Factor IX in comparison to plasma derived Factor IX was shown.
Uuringus näidati 28% madalam taastumus rekombinantse IX faktori korral, võrreldes plasmast fraktsioneeritud IX faktori preparaadiga.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple intravenous doses in different species.
Rekombinantse IX faktori farmakokineetilisi parameetreid on
The pharmacokinetic parameters obtained in studies comparing
8 määratud ka erinevatel loomaliikidel pärast ühekordseid ja korduvaid intravenoosseid annuseid.
9 recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
Rekombinantse IX faktori ja plasmast fraktsioneeritud IX faktori preparaate võrdlevates uuringutes leitud farmakokineetilised parameetrid olid sarnased tulemustega, mis olid saadud inimestel tehtud uuringus.
Structural differences of the recombinant Factor IX molecule compared with plasma derived Factor IX appear to contribute to the different recovery compared to plasma derived Factor IX.
Rekombinantse IX faktori molekuli struktuuri erinevused tunduvad mõjutavat erinevat taastumist võrreldes plasmast fraktsioneeritud IX faktori preparaadiga.
Powder Sucrose Glycine L-Histidine Polysorbate 80
Pulber Sahharoos Glütsiin L- histidiin Polüsorbaat 80
Solvent Water for injection
Lahusti Süstevesi
3 years
6. 3 Kõlblikkusaeg
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25oC.
3 aastat
Store and transport refrigerated (2°C - 8°C).
Hoida ja transportida külmas (2 ºC… 8 ºC).
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).
Ambulatoorseks kasutamiseks võib ravimi ühel korral külmkapist välja võtta mitte kauemaks kui 1 kuuks, hoides seda toatemperatuuril (kuni 25 ºC).
At the end of this period, the product should not be put back in the refrigerator, but should be used or discarded.
Selle perioodi lõpul ei tohi ravimit külmkappi tagasi panna, vaid see tuleb ära kasutada või kõrvaldada.
250 IU of powder in a vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium).
250 RÜ pulbrit (klorobutüül) korgiga ja kergestieemaldatava (alumiinium) kaanega viaalis (1. tüüpi klaas).
A tip-cap (bromobutyl) and a sterile filter spike, a sterile infusion set, two alcohol swabs, two plasters.
Otsakork (bromobutüülist) ja steriilne filterteravik, steriilne infusioonikomplekt, kaks alkoholilappi, kaks plaastrit.
10 6.6 Special precautions for disposal and other handling
6. 6 Erihoiatused ravimi hävitamiseks ja käsitlemiseks
Detailed instructions for preparation and administration are contained in the user package leaflet provided with BeneFIX.
Üksikasjalikud valmistamis - ja manustamisjuhised sisalduvad BeneFIXi pakendis olevas infolehes.
Reconstitute lyophilised BeneFIX powder for solution for injection with the supplied solvent (water for injection) using the sterile double-ended transfer needle.
9 Lahustage lüofiliseeritud BeneFIX süstelahuse pulber lisatud lahustiga (süstevesi), kasutades steriilset kahe otsaga ülekandenõela.
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.
Keerutage viaali ettevaatlikult käes, kuni kogu pulber on lahustunud.
After reconstitution, the solution is drawn through the sterile filter spike (supplied) into a sterile disposable syringe.
Pärast lahustamist tõmmatakse lahus kaasasoleva steriilse filternõela kaudu steriilsesse ühekordselt kasutatavasse süstlasse.
The solution should be discarded if visible particulate matter or discolouration is observed.
Kui lahuses on näha osakesi või värvimuutust, tuleb lahus hävitada.
BeneFIX is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied water for injections.
BeneFIXi manustatakse intravenoosse süstina pärast lüofiliseeritud süstepulbri lahustamist lisatud süsteveega.
BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2- ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Valmissegatuna sisaldab BeneFIX polüsorbaati 80, mis teadaolevalt suurendab di( 2 - etüülheksüül) ftalaadi eraldumist polüvinüülkloriidist (PVC).
It is important that the recommendations in section 4.2 be followed closely.
On oluline, et lõigus 4. 2 toodud soovitusi järgitakse tähelepanelikult.
The reconstituted solution should be used immediately or within 3 hours.
Valmistatud lahus tuleb tarvitada kohe, kuid mitte hiljem kui 3 tunni jooksul pärast valmistamist.
27 August 1997 Date of last renewal:
27. august 1997 Müügiloa viimase uuendamise kuupäev:
Detailed information on this medicinal product is available on the website of the European Medicine Agency (EMEA) http: / /www. emea. europa. eu/
Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel http: // www. emea. europa. eu /.
BeneFIX 500 IU powder and solvent for solution for injection.
BeneFIX 500 RÜ süstelahuse pulber ja lahusti.
After reconstitution with the accompanying 5 ml water for injection, each ml of the solution contains approximately 100 IU/ ml nonacog alfa.
Pärast lahustamist pakendis oleva 5 ml süsteveega sisaldab 1 ml lahust ligikaudu 100 RÜ/ ml nonakog alfat.
Each vial contains 50 mg sucrose.
Üks viaal sisaldab 50 mg sahharoosi.
13 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Manustatav kogus ja manustamissagedus tuleks alati valida lähtuvalt kliinilisest toimest konkreetsele patsiendile.
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).
11 protsentides (võrreldes terve inimese plasmaga) või rahvusvahelistes ühikutes (võrreldes rahvusvahelise standardiga IX faktori määramiseks vereplasmas).
There are insufficient data to recommend the use of BeneFIX in children less than 6 years of age.
12 Pediaatrilised patsiendid BeneFIXi kasutamise soovitamiseks alla 6 aasta vanustel lastel ei ole piisavalt andmeid.
15 4.3 Contraindications
4. 3 Vastunäidustused
In the case of shock, the current medical standards for treatment of shock should be observed.
13 Šoki korral tuleb järgida šokiravile kehtivaid meditsiinilisi standardeid.
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
Kuna IX faktori kompleksi kontsentraatide kasutamist on seostatud tromboembooliliste komplikatsioonidega, võib IX faktorit sisaldavate ravimite kasutamine olla potentsiaalselt ohtlik fibrinolüüsi nähtudega haigetel ja DIK- sündroomiga haigetel.
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.
Trombootiliste komplikatsioonide potentsiaalse riski tõttu tuleb varajaste trombootilise ja kurnava koagulopaatia nähtude ilmnemisel teostada vastavad bioloogilised testid, kui seda preparaati manustatakse maksahaigetele, operatsioonijärgselt, vastsündinutele ning trombootiliste nähtude või DIK- sündroomiga haigetele.
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.
Kuna naistel esineb hemofiiliat B harva, IX faktori kasutamise kohta raseduse ja imetamise ajal kogemused puuduvad.
4.8 Undesirable effects
14 4. 8 Kõrvaltoimed
17 Nervous system disorders
Närvisüsteemi häired
Gastrointestinal
Seedetrakti häired
Inhibitor development
15 Inhibiitori moodustumine
If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Kui inhibiitorid esinevad, võib see seisund avalduda ebapiisava kliinilise vastusena.
18 Renal
Neerukahjustus
5.2 Pharmacokinetic properties
16 5. 2 Farmakokineetilised omadused
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.
1 RÜ BeneFIXi suurendas IX faktori taset vereringes keskmiselt 0, 75 RÜ/ dl (vahemikus 0, 3... 1, 4 RÜ/ dl).
19 Table 1.
Tabel 1.
AUC0- ∞ (IU × hr/ dl)
AUC0- ∞ (RÜ × tunnis/ 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 56 619, 8 605, 2 155, 7 366, 5... 1072, 6 6 53 579, 8 562, 2 146, 1 330, 9... 900, 1 12 49 575, 7 566, 0 151, 0 290, 3... 1080, 8 18 46 561, 8 560, 9 155, 6 254, 5... 940, 8 24 45 577, 6 551, 7 154, 7 284, 1... 1045, 4
Half-life
Poolväärtusaja
0 54 2.0 1.5 1.60 0.07-5.73 1.6,2.5
0 54 2, 0 1, 5 1, 60 0, 07... 5, 73
AUC0 - ∞ = Area Under the Curve MRT = Mean Residence Time SD = Standard Deviation CI = Confidence Interval
MRT = keskmine residentsusaeg SH = standardhälve
20 A 28% lower recovery of recombinant Factor IX in comparison to plasma derived Factor IX was shown.
Uuringus näidati 28% madalam taastumus rekombinantse IX faktori korral, võrreldes plasmast fraktsioneeritud IX faktori preparaadiga.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple intravenous doses in different species.
Rekombinantse IX faktori farmakokineetilisi parameetreid on määratud ka erinevatel loomaliikidel pärast ühekordseid ja korduvaid intravenoosseid annuseid.
The pharmacokinetic parameters obtained in studies comparing recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
Rekombinantse IX faktori ja plasmast fraktsioneeritud IX faktori preparaate võrdlevates uuringutes leitud farmakokineetilised parameetrid olid sarnased tulemustega, mis olid saadud inimestel tehtud uuringus.
3 years.
6. 3 Kõlblikkusaeg
6.5 Nature and contents of container
18 6. 5 Pakendi iseloomustus ja sisu
500 IU of powder in a vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium).
500 RÜ pulbrit (klorobutüül) korgiga ja kergestieemaldatava (alumiinium) kaanega viaalis (1. tüüpi klaas).
21 6.6 Special precautions for disposal and other handling
6. 6 Erihoiatused ravimi hävitamiseks ja käsitlemiseks
Reconstitute lyophilised BeneFIX powder for solution for injection with the supplied solvent (water for injection) using the sterile double-ended transfer needle.
Lahustage lüofiliseeritud BeneFIX süstelahuse pulber lisatud lahustiga (süstevesi), kasutades steriilset kahe otsaga ülekandenõela.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kasutamata ravim ja jäätmematerjal tuleb hävitada vastavalt kohalikele seadustele.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
19 Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel http: // www. emea. europa. eu /.
BeneFIX 1000 IU powder and solvent for solution for injection
BeneFIX 1000 RÜ süstelahuse pulber ja lahusti.
After reconstitution with the accompanying 10 ml water for injection, each ml of the solution contains approximately 100 IU/ ml nonacog alfa.
Pärast lahustamist pakendis sisalduva 10 ml süsteveega sisaldab 1 ml lahust ligikaudu 100 RÜ/ ml nonakog alfat.
Each vial contains 100 mg sucrose.
Üks viaal sisaldab 100 mg sahharoosi.
24 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Manustatav kogus ja manustamissagedus tuleks alati valida lähtuvalt kliinilisest toimest konkreetsele patsiendile.
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).
21 protsentides (võrreldes terve inimese plasmaga) või rahvusvahelistes ühikutes (võrreldes rahvusvahelise standardiga IX faktori määramiseks vereplasmas).
There are insufficient data to recommend the use of BeneFIX in children less than 6 years of age.
22 Pediaatrilised patsiendid BeneFIXi kasutamise soovitamiseks alla 6 aasta vanustel lastel ei ole piisavalt andmeid.
26 4.3 Contraindications
4. 3 Vastunäidustused
In the case of shock, the current medical standards for treatment of shock should be observed.
23 Šoki korral tuleb järgida šokiravile kehtivaid meditsiinilisi standardeid.
4.8 Undesirable effects
24 4. 8 Kõrvaltoimed
28 Nervous system disorders
Närvisüsteemi häired
Inhibitor development
25 Inhibiitori moodustumine
29 Renal
Neerukahjustus
5.2 Pharmacokinetic properties
26 5. 2 Farmakokineetilised omadused
30 Table 1.
Tabel 1.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and
Rekombinantse IX faktori farmakokineetilisi parameetreid on määratud ka erinevatel loomaliikidel pärast ühekordseid ja korduvaid intravenoosseid annuseid.
The pharmacokinetic parameters obtained in studies comparing recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
Rekombinantse IX faktori ja plasmast farktsioneeritud IX faktori preparaate võrdlevates uuringutes leitud farmakokineetilised parameetrid olid sarnased tulemustega, mis olid saadud inimestel tehtud uuringus.
1000 IU of powder in a vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium).
1000 RÜ pulbrit (klorobutüül) korgiga ja kergestieemaldatava (alumiinium) kaanega viaalis (1. tüüpi klaas).
32 6.6 Special precautions for disposal and other handling
28 6. 6 Erihoiatused ravimi hävitamiseks ja käsitlemiseks
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMEA) kodulehel http: // www. emea. europa. eu /.
34 1.
29 1.
After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 50 IU nonacog alfa.
Pärast lahustamist pakendis oleva 5 ml (0, 234%) naatriumkloriidi süstelahusega sisaldab lahuse 1 ml ligikaudu 50 RÜ nonakog alfat.
Each vial contains 40 mg sucrose.
Üks viaal sisaldab 40 mg sahharoosi.
For a full list of excipients, see section 6.1.
Abiainete täielikku loetelu vt lõik 6. 1.
White/ almost white powder and clear and colourless solvent for solution for injection.
Süstelahuse valge/ peaaegu valge pulber ja selge ja värvitu lahusti.
35 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Manustatav kogus ja manustamissagedus tuleks alati valida lähtuvalt kliinilisest toimest konkreetsele patsiendile.
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).
30 protsentides (võrreldes terve inimese plasmaga) või rahvusvahelistes ühikutes (võrreldes rahvusvahelise standardiga IX faktori määramiseks vereplasmas).
For a recovery 0.8 IU/ dl (average increase of factor IX), then:
Kui leitud taastumus on 0, 8 RÜ/ dl (IX faktori taseme keskmine tõus), siis:
1.3 IU/ kg
1, 3 RÜ/ kg
There are insufficient data to recommend the use of BeneFIX in children less than 6 years of age.
31 Pediaatrilised patsiendid BeneFIXi kasutamise soovitamiseks alla 6 aasta vanustel lastel ei ole piisavalt andmeid.
BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile 0.234% sodium chloride solution (see section 6.6).
Manustamisviis BeneFIXi manustatakse intravenoosse infusiooni teel süstelahusena, mis on valmistatud lüofiliseeritud süstelahuse pulbri lahustamise teel steriilse 0, 234% - lise naatriumkloriidi lahusega (vt lõik 6. 6).
37 4.3 Contraindications
4. 3 Vastunäidustused
In the case of shock, the current medical standards for treatment of shock should be observed.
32 Šoki korral tuleb järgida šoki ravile kehtivaid meditsiinilisi standardeid.
4.8 Undesirable effects
33 4. 8 Kõrvaltoimed
Dizziness, headache, altered taste, lightheadedness
Pearinglus, peavalu, maitsemuutus, peapööritus
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
Neutraliseerivad antikehad (IX faktori inhibiitorid) * Ülitundlikkus/ allergilised reaktsioonid; sellisteks reaktsioonideks võivad olla anafülaksia *, bronhospasm/ respiratoorse distressi sündroom, hüpotensioon, angioödeem, tahhükardia, pitsitustunne rinnus, üldine nõgestõbi, nahapõletik, lööve, põletustunne lõualuus ja koljus, külmavärinad, kipitustunne, õhetus, letargia, rahutus, kuiv köha/ aevastamine
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.
34 inhibiitorid avastati ühel haigel 65- st uuritud BeneFIX preparaadiga ravitud haigest (sealhulgas 9 patsienti, kes osalesid ainult kirurgilistel uuringutel), kes olid varem saanud plasmaprodukte.
Renal
Neerukahjustus
The medicinal product has been authorised under “ Exceptional Circumstances”
Ravimpreparaat on saanud müügiloa erandlikel asjaoludel.
Recombinant Factor IX Parameters for Activity Data by Month in Previously Treated Patients
Rekombinantse IX faktori aktiivsuse andmed eelnevalt ravitud haigetel kuude kaupa
41 Table 1.
Parameeter
Recombinant Factor IX Parameters for Activity Data by Month in Previously Treated Patients
Kuu n Kesk - Mediaan SH Vahemik 95% usal - mine dusvahemik
Parameter
Taastumus (%)
Month n Mean Median SD Range 95% CI 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
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
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 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 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
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
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
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