natgillin/translations-raw huggingface dataset:
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
17 To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
19 Table 1.
Povpre čje
AUC0- ∞ (IU × hr/ dl)
AUC0- ∞ (i. e. × h/ dl)
Initial Phase (hrs)
Razpolovni čas Začetna faza (h)
20 A 28% lower recovery of recombinant Factor IX in comparison to plasma derived Factor IX was shown.
Izkazalo se je, da je porast aktivnosti rekombinantnega faktorja IX za 28% manjši od porasta aktivnosti faktorja IX, izdelanega iz plazme.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple intravenous doses in different species.
Farmakokinetični parametri, dobljeni v študijah, v katerih so primerjali rekombinantni faktor IX in faktor IX, izdelan iz plazme,, so bili podobni tistim, ki so jih dobili v študijah pri ljudeh.
The pharmacokinetic parameters obtained in studies comparing recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
Zdi se, da k različnemu porastu aktivnosti rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz
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.
19 plazme, prispevajo strukturne razlike molekule rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme.
500 IU of powder in a vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium).
500 i. e. praška v viali (steklo tipa I) z zamaškom (iz klorobutilne gume) in zaporko (iz aluminija).
21 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Reconstitute lyophilised BeneFIX powder for solution for injection with the supplied solvent (water for injection) using the sterile double-ended transfer needle.
20 Rekonstituirajte liofilizirani prašek za raztopino za injiciranje BeneFIX s priloženim vehiklom (vodo za injekcije) s sterilno iglo za prenos z dvema konicama.
BeneFIX 1000 IU powder and solvent for solution for injection
BeneFIX 1. 000 i. e. prašek in vehikel za raztopino za injiciranje.
Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX).
Ena viala vsebuje nominalno 1. 000 i. e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
After reconstitution with the accompanying 10 ml water for injection, each ml of the solution contains approximately 100 IU/ ml nonacog alfa.
Po rekonstituciji s priloženimi 10 ml vode za injekcije en mililiter raztopine vsebuje približno 100 i. e. / ml nonakoga alfa.
Each vial contains 100 mg sucrose.
Ena viala vsebuje 100 mg saharoze.
24 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Količino in pogostost uporabe zdravila je potrebno prilagoditi glede na klinično učinkovitost v posameznem primeru.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
22 Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i. e.), ki so prilagojene trenutnim standardom SZO za pripravke faktorja IX.
For long term prophylaxis against bleeding in patients with severe haemophilia B, BeneFIX may be administered.
23 Za dolgoročno profilakso krvavitev pri bolnikih s težko hemofilijo B lahko uporabljamo BeneFIX.
26 4.3 Contraindications
4. 3 Kontraindikacije
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, hypotension, and anaphylaxis.
24 Bolnike je potrebno informirati o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, srbenje, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
4.7 Effects on ability to drive and use machines
25 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
28 Nervous system disorders
Bolezni živčevja
Due to the production process BeneFIX contains trace amounts of hamster cell proteins.
26 Zaradi postopka izdelave BeneFIX vsebuje sledove celičnih beljakovin hrčka.
29 Renal
Ledvice
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
27 To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
30 Table 1.
Povpre čje
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and
Določili so tudi farmakokinetične parametre rekombinantnega faktorja IX po enem samem in več intravenskih odmerkih pri različnih vrstah.
The pharmacokinetic parameters obtained in studies comparing recombinant Factor IX to plasma derived Factor IX were similar to those obtained in human studies.
Zdi se, da k
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.
29 različnemu porastu aktivnosti rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme, prispevajo strukturne razlike molekule rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme.
1000 IU of powder in a vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium).
1. 000 i. e. praška v viali (steklo tipa I) z zamaškom (iz klorobutilne gume) in zaporko (iz aluminija).
32 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Reconstitute lyophilised BeneFIX powder for solution for injection with the supplied solvent (water for injection) using the sterile double-ended transfer needle.
30 Rekonstituirajte liofilizirani prašek za raztopino za injiciranje BeneFIX s priloženim vehiklom (vodo za injekcije) s sterilno iglo za prenos z dvema konicama.
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.
Po rekonstituciji s priloženimi 5 ml (0, 234- odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 50 i. e. nonakoga alfa.
Each vial contains 40 mg sucrose.
Ena viala vsebuje 40 mg saharoze.
35 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Količino in pogostost uporabe zdravila je potrebno prilagoditi glede na klinično učinkovitost v posameznem primeru.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
32 Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i. e.), ki so prilagojene trenutnim standardom SZO za pripravke faktorja IX.
For a recovery 0.8 IU/ dl (average increase of factor IX), then:
Za porast koncentracije 0, 8 i. e. / dl (povprečno zvišanje faktorja IX), sledi:
1.3 IU/ kg
1, 3 i. e. / kg
For long term prophylaxis against bleeding in patients with severe haemophilia B, BeneFIX may be administered.
33 Za dolgoročno profilakso krvavitev pri bolnikih s težko hemofilijo B lahko uporabljamo BeneFIX.
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).
Način uporabe BeneFIX se daje z intravensko infuzijo po rekonstituciji liofiliziranega praška za raztopino za injiciranje s sterilno raztopino 0, 234- odstotnega natrijevega klorida (glejte poglavje 6. 6).
37 4.3 Contraindications
4. 3 Kontraindikacije
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, hypotension, and anaphylaxis.
34 Bolnike je potrebno informirati o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, srbenje, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing.
Pomembno je, da omejite količino krvi, ki vstopi v infuzijski sistem, s čimer kar najbolj zmanjšate možnost aglutinacije.
4.7 Effects on ability to drive and use machines
35 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Neutralising antibodies (factor IX inhibition)* Hypersensitivity/ allergic reactions; such reactions may include anaphylaxis*, bronchospasm/ respiratory distress, hypotension, angioedema, tachycardia, chest tightness, generalised urticarial, hives, rash, burning sensation in jaw and skull, chills (rigors), tingling, flushing, lethargy, restlessness, dry cough/ sneezing
nevtralizirajoča protitelesa (inhibicija faktorja IX) * preobčutljivostne/ alergijske reakcije; takšne reakcije lahko vključujejo anafilaksijo *, bronhospazem/ dihalno stisko, hipotenzijo, angioedem, tahikardijo, stiskanje v prsih, generalizirano koprivnico, izpuščaje, pekoč občutek v čeljusti in lobanji, mrzlico, mravljinčenje, rdečico, letargijo, nemir, suh kašelj/ kihanje
Inhibitor development
36 Razvoj inhibitorja
Renal
Ledvice
40 4.9 Overdose
4. 9 Preveliko odmerjanje
The medicinal product has been authorised under “ Exceptional Circumstances”
Zdravilo je pridobilo dovoljenje za promet v “ izjemnih okoliščinah ”.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
37 Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
Table 1.
Povpre čje
Recombinant Factor IX Parameters for Activity Data by Month in Previously Treated Patients
33, 7 31, 8 31, 3 30, 7 31, 0
Month n Mean Median SD Range 0 56 33.7 31.5 10.31 15.3– 62.2
15, 3– 62, 2 15, 3– 56, 7 16, 2– 53, 1 12, 6– 62, 1 16, 2– 59, 4
95% CI 30.9, 36.4
30, 9, 36, 4 29, 4, 34, 3 28, 8, 33, 7 28, 0, 33, 5 28, 4, 33, 6
41 Table 1.
0 6 12 18 24
Recombinant Factor IX Parameters for Activity Data by Month in Previously Treated Patients
56 53 50 47 47
Parameter
0, 75 0, 71 0, 70 0, 68 0, 69
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, 70 0, 69 0, 68 0, 64 0, 68
42 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.
39 plazme, prispevajo strukturne razlike molekule rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme.
Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25oC.
Rekonstituirano zdravilo je treba uporabiti takoj, najpozneje pa 3 ure po rekonstituciji.
Do not freeze, in order to prevent damage to the prefilled syringe.
Ne zamrzujte, da se napolnjena injekcijska brizga ne bo poškodovala.
250 IU of powder in a 10 ml vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 ml of solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad.
250 i. e. praška v 10- mililitrski viali (steklo tipa I) z zamaškom (iz klorobutila) in zaporko (iz aluminija) in 5 ml vehikla v napolnjeni injekcijski brizgi (steklo tipa I), zamašeni z batom (iz bromobutila), s koničastim pokrovčkom (iz bromobutila) in sterilnim rekonstitucijskim adapterjem za vialo, sterilen infuzijski sistem, dva alkoholna zloženca, obliž in blazinica iz gaze.
43 6.6 Special precautions for disposal and other handling
40 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
BeneFIX is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied solvent (0.234% w/ v sodium chloride solution) in the pre-filled syringe.
BeneFIX se daje z intravensko (i. v.) injekcijo po rekonstituciji liofiliziranega praška za injekcijo s priloženim vehiklom (0, 234- odstotno (m/ v) raztopino natrijevega klorida) v napolnjeni injekcijski brizgi.
It is important that the recommendations in section 4.2 be followed closely.
Dosledno upoštevajte navodila v poglavju 4. 2.
After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 100 IU nonacog alfa
Po rekonstituciji s priloženimi 5 ml (0, 234- odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 100 i. e. nonakoga alfa.
45 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Količino in pogostost uporabe zdravila je potrebno prilagoditi glede na klinično učinkovitost v posameznem primeru.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
42 Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i. e.), ki so prilagojene trenutnim standardom SZO za pripravke faktorja IX.
For long term prophylaxis against bleeding in patients with severe haemophilia B, BeneFIX may be administered.
43 Za dolgoročno profilakso krvavitev pri bolnikih s težko hemofilijo B lahko uporabljamo BeneFIX.
47 4.3 Contraindications
4. 3 Kontraindikacije
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, hypotension, and anaphylaxis.
44 Bolnike je potrebno informirati o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, srbenje, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
4.7 Effects on ability to drive and use machines
45 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
49 Nervous system disorders
Bolezni živčevja
Due to the production process BeneFIX contains trace amounts of hamster cell proteins.
46 Zaradi postopka izdelave BeneFIX vsebuje sledove celičnih beljakovin hrčka.
50 Renal
Ledvice
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
47 To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
51 Table 1.
Povpre čje
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.
49 plazme, prispevajo strukturne razlike molekule rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme.
53 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
500 IU of powder in a 10 ml vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 ml of solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad.
500 i. e. praška v 10- mililitrski viali (steklo tipa I) z zamaškom (iz klorobutila) in zaporko (iz aluminija) in 5 ml vehikla v napolnjeni injekcijski brizgi (steklo tipa I), zamašeni z batom (iz bromobutila), s koničastim pokrovčkom (iz bromobutila) in sterilnim rekonstitucijskim adapterjem za vialo, sterilen infuzijski sistem, dva alkoholna zloženca, obliž in blazinica iz gaze.
6.6 Special precautions for disposal and other handling
50 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 200 IU nonacog alfa
Po rekonstituciji s priloženimi 5 ml (0, 234- odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 200 i. e. nonakoga alfa.
55 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Količino in pogostost uporabe zdravila je potrebno prilagoditi glede na klinično učinkovitost v posameznem primeru.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
52 Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i. e.), ki so prilagojene trenutnim standardom SZO za pripravke faktorja IX.
Repeat infusion every 24 hours for 3- 4 days or more until pain and acute disability are resolved.
Ponavljajte infuzijo vsakih 24 ur 3 - 4 dni ali še dalj, dokler ne izzvenita bolečina in akutna nezmožnost.
For long term prophylaxis against bleeding in patients with severe haemophilia B, BeneFIX may be administered.
53 Za dolgoročno profilakso krvavitev pri bolnikih s težko hemofilijo B lahko uporabljamo BeneFIX.
57 4.3 Contraindications
4. 3 Kontraindikacije
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, hypotension, and anaphylaxis.
54 Bolnike je potrebno informirati o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, srbenje, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
In the case of shock, the current medical standards for shock-treatment should be observed.
V primeru šoka se je potrebno ravnati po trenutno veljavnih medicinskih standardih za zdravljenje šoka.
59 Nervous system disorders
Bolezni živčevja
Inhibitor development
56 Razvoj inhibitorja
60 Renal
Ledvice
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
57 Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
61 Table 1.
Povpre čje
A 28% lower recovery of recombinant BeneFIX in comparison to plasma derived Factor IX was shown.
Izkazalo se je, da je porast aktivnosti rekombinantnega zdravila BeneFIX za 28% manjši od porasta aktivnosti faktorja IX, izdelanega iz plazme.
Pharmacokinetic parameters of recombinant Factor IX have also been determined after single and multiple
Določili so tudi farmakokinetične parametre rekombinantnega faktorja IX po enem samem in več intravenskih odmerkih pri različnih vrstah.
62 intravenous doses in different species.
Farmakokinetični parametri, dobljeni v študijah, v katerih so primerjali rekombinantni faktor IX in faktor IX, izdelan iz plazme, so bili podobni tistim, ki so jih dobili v študijah pri ljudeh.
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.
59 plazme, prispevajo strukturne razlike molekule rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme.
63 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
1000 IU of powder in a 10 ml vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 ml of solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad.
1. 000 i. e. praška v 10- mililitrski viali (steklo tipa I) z zamaškom (iz klorobutila) in zaporko (iz aluminija) in 5 ml vehikla v napolnjeni injekcijski brizgi (steklo tipa I), zamašeni z batom (iz bromobutila), s koničastim pokrovčkom (iz bromobutila) in sterilnim rekonstitucijskim adapterjem za vialo, sterilen infuzijski sistem, dva alkoholna zloženca, obliž in blazinica iz gaze.
6.6 Special precautions for disposal and other handling
60 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
BeneFIX 2000 IU powder and solvent for solution for injection.
BeneFIX 2. 000 i. e. prašek in vehikel za raztopino za injiciranje.
Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).
Ena viala vsebuje nominalno 2. 000 i. e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 400 IU nonacog alfa.
Po rekonstituciji s priloženimi 5 ml (0, 234- odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 400 i. e. nonakoga alfa.
66 parameters such as half-life and recovery, as well as the clinical situation into consideration in order to adjust the dose as appropriate.
Količino in pogostost uporabe zdravila je potrebno prilagoditi glede na klinično učinkovitost v posameznem primeru.
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
62 Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i. e.), ki so prilagojene trenutnim standardom SZO za pripravke faktorja IX.
For long term prophylaxis against bleeding in patients with severe haemophilia B, BeneFIX may be administered.
63 Za dolgoročno profilakso krvavitev pri bolnikih s težko hemofilijo B lahko uporabljamo BeneFIX.
68 4.3 Contraindications
4. 3 Kontraindikacije
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, hypotension, and anaphylaxis.
64 Bolnike je potrebno informirati o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, srbenje, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
4.7 Effects on ability to drive and use machines
65 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
70 Nervous system disorders
Bolezni živčevja
Inhibitor development
66 Razvoj inhibitorja
71 Renal
Ledvice
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
67 Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
72 Table 1.
Povpre čje
73 intravenous doses in different species.
Farmakokinetični parametri, dobljeni v študijah, v katerih so primerjali rekombinantni faktor IX in faktor IX, izdelan iz plazme, so bili podobni tistim, ki so jih dobili v študijah pri ljudeh.
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.
69 plazme, prispevajo strukturne razlike molekule rekombinantnega faktorja IX v primerjavi s faktorjem IX, izdelanim iz plazme.
74 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina