natgillin/translations-raw huggingface dataset:
Because the use of BeneFIX by continuous infusion (drip) has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
Ker uporabe zdravila BeneFIX s kontinuirano (kapalno) infuzijo niso ovrednotili, zdravila BeneFIX ne smete mešati z raztopinami za infundiranje ali dajati v kapalni infuziji.
In a randomized, cross-over pharmacokinetic study, BeneFIX reconstituted in 0.234% sodium chloride diluent was shown to be pharmacokinetically equivalent to the previously marketed BeneFIX (reconstituted with sterile water) in 24 previously treated patients (≥12 years) at a dose of 75 IU/kg.
V randomizirani, navzkrižni farmakokinetični študiji so pri 24 predhodno zdravljenih bolnikih (≥ 12 let) pokazali, da je zdravilo BeneFIX v odmerku 75 i.e./kg, rekonstituirano v vehiklu 0,234 % natrijevega klorida, farmakokinetično ekvivalentno predhodno trženemu zdravilu BeneFIX (rekonstituiranemu z vodo za injekcije).
1500 IU
1.500 i.e.
What BeneFIX looks like and contents of the pack
Izgled zdravila BeneFIX in vsebina pakiranja
- The active substance is nonacog alfa (recombinant coagulation factor IX).
Učinkovina je nonakog alfa (rekombinantni koagulacijski faktor IX).
Use only the pre-filled syringe provided in the box for reconstitution.
Za rekonstitucijo uporabite le napolnjeno brizgo, ki je priložena v škatli.
Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Posamezni bolniki se lahko različno odzivajo na faktor IX, kar se kaže v različnih razpolovnih časih in porastih koncentracije faktorja IX.
Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, generalised urticaria, itching, tightness of the chest, bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis.
Bolnike je treba poučiti o zgodnjih znakih preobčutljivostnih reakcij, kot so oteženo dihanje, kratka sapa, otekanje, izpuščaji, generalizirana urtikarija, srbenje, tiščanje v prsnem košu, bronhospazem, laringospazem, sopenje, hipotenzija, zamegljen vid 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 zmanjšate možnost aglutinacije.
Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.
Pritrdite brizgo z vehiklom na nastavek za vialo, tako da vstavite vrh brizge v odprtino nastavka in hkrati čvrsto potiskate in sukate brizgo v smeri urnega kazalca, dokler se brizga in nastavek ne spojita.
The potency (IU) is determined using the European Pharmacopoeia one-stage clotting assay.
Aktivnost (i.e.) določamo z enofaznim koagulacijskim testom po Evropski farmakopeji.
BeneFIX should be administered at a slow infusion rate.
Zdravilo BeneFIX je treba infundirati z majhno hitrostjo.
There have been reports of clumping (agglutination) of red blood cells in the tube/syringe with the administration of BeneFIX.
Poročali so o zlepljanju (aglutinaciji) rdečih krvničk v infuzijskem sistemu/brizgi ob dajanju zdravila BeneFIX.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for BeneFIX
IME ZDRAVILA IN POT(I) UPORABE
Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding
Zgodnja hemartroza, krvavitev v mišico ali v ustno votlino
Slowly depress the plunger rod to inject all the solvent into the BeneFIX vial
S počasnim potiskanjem bata izbrizgajte ves vehikel v vialo z zdravilom BeneFIX.
When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor IX activity in patients' blood samples, plasma factor IX activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Kadar aktivnost faktorja IX v bolnikovih krvnih vzorcih določamo z enofaznim koagulacijskim testom na podlagi in vitro tromboplastinskega časa (aPTČ - aktivirani parcialni tromboplastinski čas), lahko na rezultate aktivnosti faktorja IX pomembno vplivata vrsta reagenta za aPTČ in referenčni standard, ki ga uporabljamo pri testiranju.
Solvent Sodium chloride solution
Vehikel raztopina natrijevega klorida
Inadequate factor IX recovery p,
Preiskave nezadosten porast faktorja IX
BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for injection with the supplied solvent (0.234% w/v sodium chloride solution) in the pre-filled syringe (see also section 3 of the package leaflet for reconstitution instructions).
Zdravilo BeneFIX se daje z intravensko infuzijo po rekonstituciji liofiliziranega praška za injiciranje s priloženim vehiklom (0,234-odstotno (m/v) raztopino natrijevega klorida) v napolnjeni brizgi (za navodila za rekonstitucijo glejte tudi poglavje 3 navodila za uporabo).
How to take BeneFIX
Kako uporabljati zdravilo BeneFIX
- Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (patients who have never received a previous infusion of factor IX), with BeneFIX.
Iz kliničnih študij pri bolnikih, ki se zdravijo z zdravilom BeneFIX in pred tem niso prejemali zdravljenja (bolniki, ki nikoli niso prejeli infuzije faktorja IX), še niso pridobili dovolj podatkov.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Opazili so preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in zbadanje na mestu infuzije, mrzlico, zardevanje, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, tiščanje v prsnem košu, mravljinčenje, bruhanje, sopenje), ki se lahko v nekaterih primerih razvijejo v hudo anafilaksijo (vključno s šokom).
BeneFIX should be administered using the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe.
Zdravilo BeneFIX si morate dati s priloženo napolnjeno injekcijsko brizgo za vehikel ali z eno samo sterilno plastično injekcijsko brizgo za enkratno uporabo z nastavkom po Luerju.
Read the package leaflet before use.
za intravensko uporabo, samo za enkratno uporabo Pred uporabo preberite priloženo navodilo!
Amount of BeneFIX per Vial
Količina zdravila BeneFIX na vialo
It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Opozoriti je treba, da utegnejo biti bolniki z inhibitorji faktorja IX ob poznejšem ponovnem stiku s faktorjem IX v večji nevarnosti anafilaksije.
Allow the vial of lyophilised (freeze-dried) BeneFIX and the pre-filled syringe to reach room temperature.
Vialo z liofiliziranim (sušenim z zamrzovanjem) zdravilom BeneFIX in napolnjeno injekcijsko brizgo z vehiklom segrejte na sobno temperaturo.
- Activity-neutralizing antibodies (inhibitors) are an uncommon event in patients who have received previous treatment with factor IX-containing products.
Aktivnost nevtralizirajoča protitelesa (inhibitorji) se občasno pojavijo pri bolnikih, ki so že prejemali zdravila, ki vsebujejo faktor IX.
Such reactions may include swelling of the face or throat, burning and stinging at the infusion site, chills, flushing, itching, headache, hives, low blood pressure, lethargy, nausea, restlessness, fast heart rate, tightness of the chest, tingling, vomiting, wheezing).
Te reakcije lahko vključujejo otekanje obraza ali žrela, pekoč občutek in zbadanje na mestu infuzije, mrzlico, zardevanje, srbenje, glavobol, koprivnico, nizek krvni tlak, letargijo, občutek siljenja na bruhanje, nemir, hiter srčni utrip, tiščanje v prsnem košu, mravljinčenje, bruhanje, sopenje.
- If you have any further questions, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
• one vial of BeneFIX 250, 500, 1000, 1500, 2000 or 3000 IU powder
• eno vialo zdravila BeneFIX 250, 500, 1.000, 1.500, 2.000 ali 3.000 i.e. v obliki praška,
If clumping of red blood cells in the tubing/syringe is observed, discard all this material (tubing, syringe and BeneFIX solution) and resume administration with a new package.
Če opazite zlepljanje rdečih krvničk v infuzijskem sistemu/brizgi, zavrzite ves material (infuzijski sistem, brizgo in raztopino zdravila BeneFIX) in nadaljujte z uporabo novega kompleta.
Early signs of allergic reactions include difficulty breathing, shortness of breath, swelling, hives, itching, generalised urticaria, tightness of the chest, wheezing, low blood pressure, blurred vision and anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands).
izpuščaje, srbenje, generalizirano urtikarijo, tiščanje v prsnem košu, sopenje, nizek krvni tlak, zamegljen vid in anafilaksijo (huda alergijska reakcija, ki lahko povzroči težave pri požiranju in/ali dihanju, rdeč ali otekel obraz in/ali roke).
• one gauze pad
•en obliž,
If agglutination of red blood cells in the tubing/syringe is observed, discard all this material (tubing, syringe and BeneFIX solution) and resume administration with a new package.
Če opazite aglutinacijo rdečih krvničk v infuzijskem sistemu/brizgi, zavrzite ves material (infuzijski sistem, brizgo in raztopino zdravila BeneFIX) in aplikacijo nadaljujte z novim zavitkom.
Use the reconstituted solution immediately or within 3 hours.
Rekonstituirano raztopino porabite takoj ali v 3 urah po rekonstituciji.
No MedDRA 17.1 PT was retrieved.
V MedDRA 17.1 ni prednostnega izraza (PT - Preferred Term).
Dose based on bodyweight may require adjustment in underweight or overweight patients.
Pri bolnikih s premajhno ali prekomerno telesno maso bo morda treba prilagoditi odmerek, odvisen od telesne mase.
BeneFIX should be administered immediately or within 3 hours after reconstitution.
Zdravilo BeneFIX morate uporabiti nemudoma ali v 3 urah po rekonstituciji.
Discard the vial with the adapter attached.
Zavrzite vialo skupaj s pritrjenim nastavkom.
No symptoms of overdose have been reported with recombinant coagulation factor IX products.
Pri zdravilih z rekombinantnim koagulacijskim faktorjem IX niso poročali o nobenih simptomih prevelikega odmerjanja.
Number of subjects Clearance (mL/h/kg)
Očistek (ml/h/kg)
BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU powder and solvent for solution for injection
BeneFIX 250 i.e., 500 i.e., 1.000 i.e., 1.500 i.e., 2.000 i.e., 3.000 i.e. prašek in vehikel za raztopino za injiciranje
Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
Zavitek pritisnite čvrsto navzdol, da se nastavek zaskoči na svoje mesto na vrhu viale, hkrati pa konica nastavka predre zamašek viale.
BeneFIX contains recombinant coagulation factor IX, (nonacog alfa).
Zdravilo BeneFIX vsebuje rekombinantni koagulacijski faktor IX (nonakog alfa).
Do not use this medicine if you notice the solution is not clear or colourless.
Če raztopina ni bistra in brez barve, zdravila ne uporabite.
3000 IU
3.000 i.e.
m including injection site pain, infusion-site discomfort n including infusion-site pruritus, infusion-site erythema o including chest pain and chest tightness p
vključno z bolečino na mestu injiciranja, neprijetnim občutkom na mestu infundiranja vključno s pruritusom na mestu infundiranja, eritemom na mestu infundiranja vključno z bolečino v prsnem košu in tiščanjem v prsnem košu to je dobesedni izraz.
The rate of administration should be determined by the patient's comfort level.
Hitrost dajanja zdravila je treba prilagoditi bolnikovemu počutju.
The final solution should be inspected visually for fine particles before administration.
Končno raztopino pred uporabo natančno preglejte glede prisotnosti vidnih delcev.
• one sterile vial adapter reconstitution device
• en sterilen rekonstitucijski nastavek za vialo,
- See your doctor immediately if your bleeding does not stop as expected.
Če se vam krvavitev ne ustavi, kot ste pričakovali, nemudoma obiščite zdravnika.
Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise.
Odstranite brizgo z nastavka za vialo, tako da brizgo previdno povlečete in zasukate v smeri, nasprotni urnemu kazalcu.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistem inhibicija faktorja IX
600 IU
600 i.e.
2000 IU
2.000 i.e.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 5 ml of 0.234% sodium chloride solution for injection
Vsebuje 5 ml 0,234-odstotne raztopine natrijevega klorida za injekcije.
Visual impairment e
Očesne bolezni poslabšanje vida
BeneFIX is administered by intravenous (IV) infusion after reconstitution of the powder for injection with the supplied solvent (a sodium chloride (salt) solution) in the pre-filled syringe.
infuzija po rekonstituciji praška za injiciranje s priloženim vehiklom (raztopina natrijevega klorida (soli)) v napolnjeni injekcijski brizgi.
1 pre-filled syringe with 5 ml solvent 1 sterile vial adapter reconstitution device 1 sterile infusion set
1 sterilen rekonstitucijski nastavek za vialo 1 sterilen infuzijski sistem 2 alkoholna zloženca
How to store BeneFIX
Shranjevanje zdravila BeneFIX
Inhibitors are an uncommon event in previously treated patients (PTPs) receiving factor IX-containing products.
Pojav inhibitorjev pri predhodno zdravljenih bolnikih (PTP) z zdravili, ki vsebujejo faktor IX, je redek.
1000 IU
1.000 i.e.
200 IU
200 i.e.
Please contact your doctor immediately if you inject more BeneFIX than your doctor recommends.
Če ste si injicirali več zdravila BeneFIX, kot vam je priporočil zdravnik, nemudoma obiščite zdravnika.
Aseptic technique (meaning clean and germ free) should be used during the reconstitution procedure.
Med postopkom rekonstitucije morate uporabljati aseptično tehniko (t.j.
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection Nonacog alfa (recombinant coagulation factor IX)
BeneFIX 250 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 2.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 3.000 i.e. prašek in vehikel za raztopino za injiciranje nonakog alfa (rekombinantni koagulacijski faktor IX)
Potentially life-threatening anaphylactic reactions (severe allergic reactions) have occurred with factor IX products, including BeneFIX.
Pri zdravilih s faktorjem IX, vključno z zdravilom BeneFIX, se pojavljajo anafilaktične reakcije (hude alergijske reakcije), ki so lahko življenjsko ogrožajoče.
BeneFIX contains recombinant coagulation factor IX, (INN = nonacog alfa).
Zdravilo BeneFIX vsebuje rekombinantni koagulacijski faktor IX (INN = nonakog alfa).
Elimination half-life (h) Recovery (IU/dL per IU/kg)
Razpolovni čas izločanja (h) Porast koncentracije faktorja IX (i.e./dl na i.e./kg)
If you get any side effects talk to your doctor, pharmacist or nurse.
Če opazite katerikoli neželeni učinek, se posvetujte zzdravnikom, farmacevtom ali medicinsko sestro.
• Sleepiness, shaking
• izpuščaj, koprivnica
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection
BeneFIX 250 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 1.500 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 2.000 i.e. prašek in vehikel za raztopino za injiciranje BeneFIX 3.000 i.e. prašek in vehikel za raztopino za injiciranje
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Pri bolnikih s hemofilijo B z inhibitorji faktorja IX in anamnezo alergijske reakcije so poročali o nefrotskem sindromu po poskusu indukcije imunske tolerance.
Lot See front label (Lot, Exp.)
Glejte sprednjo oznako (Številka serije, Uporabno do)
There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Obstajajo literaturna poročila, ki kažejo korelacijo med pojavom inhibitorja faktorja IX in alergijskimi reakcijami, zato moramo bolnike, ki doživijo alergijsko reakcijo, testirati na prisotnost inhibitorja.
Very common
Večje
• one plaster
1 obliž
Attach the plunger rod to the solvent syringe by pushing and turning firmly.
Pritrdite bat na injekcijsko brizgo z vehiklom, tako da ga čvrsto potisnete in zasukate.
Infusion-site cellulitis a
Infekcijske in parazitske bolezni celulitis na mestu infundiranja
BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX).
BeneFIX 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX).
BeneFIX 250 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
BeneFIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU nonacog alfa (recombinant coagulation factor IX).
BeneFIX 3.000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 3.000 i.e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
Your doctor may advise you to stop treatment with BeneFIX if you are breast-feeding or become pregnant.
Če dojite ali zanosite, vam utegne zdravnik svetovati, da prekinite zdravljenje z zdravilom BeneFIX.
BeneFIX 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU nonacog alfa (recombinant coagulation factor IX).
BeneFIX 1.500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1.500 i.e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
1 vial: 500 IU nonacog alfa (approx. 100 IU/ml after reconstitution).
1 viala: 500 i.e. nonakoga alfa (pribl.
• Vomiting, nausea
• bruhanje, občutek siljenja na bruhanje
BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX).
BeneFIX 1.000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1.000 i.e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
Vomiting; nausea
Bolezni prebavil bruhanje, navzea
Inadequate therapeutic response*
Bolezni imunskega sistema preobčutljivost anafilaktična reakcija*
1 vial: 1500 IU nonacog alfa (approx. 300 IU/ml after reconstitution).
1 viala: 1.500 i.e. nonakoga alfa (pribl.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU nonacog alfa (approx. 50 IU/ml after reconstitution).
1 viala: 250 i.e. nonakoga alfa (pribl.
1 vial: 1000 IU nonacog alfa (approx. 200 IU/ml after reconstitution).
1 viala: 2.000 i.e. nonakoga alfa (pribl.
Superior vena cava syndrome i,
Žilne bolezni flebitis, zardevanje hipotenzija sindrom zgornje vene kave i,
1 vial: 3000 IU nonacog alfa (approx. 600 IU/ml after reconstitution).
1 viala: 3.000 i.e. nonakoga alfa (pribl.
- A kidney disorder (nephrotic syndrome) has been reported following high doses of plasma-derived factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Pri bolnikih s hemofilijo B z inhibitorji faktorja IX, ki so v preteklosti doživeli alergijske reakcije, poročajo o motnji delovanja ledvic (nefrotskem sindromu) po prejemu velikih odmerkovfaktorja IX, pridobljenega iz plazme.
BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).
BeneFIX 2.000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2.000 i.e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
Potentially life-threatening anaphylactic/anaphylactoid reactions have occurred with factor IX products, including BeneFIX.
Pri zdravilih s faktorjem IX, vključno z zdravilom BeneFIX, so se pojavile anafilaktične/anafilaktoidne reakcije, ki so lahko bile življenjsko ogrožajoče.
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.
You may notice a difference in the dose you receive if you are changing from a plasma-derived factor IX product to BeneFIX.
Ob prehodu s faktorja IX, pridobljenega iz plazme, na zdravilo BeneFIX boste morda opazili razliko v odmerku.
After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 600 IU nonacog alfa.
Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 600 i.e. nonakoga alfa.
Ensuring that the syringe plunger rod is still fully depressed, invert the vial.
Prepričajte se, da je bat brizge še vedno do konca potisnjen navzdol, in zasukajte vialo s spodnjim koncem navzgor.
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.
After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa.
Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 300 i.e. nonakoga alfa.
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.
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.
In such cases, the Western blot method is negative.
V takšnih primerih je metoda Western blot negativna.
Date of first authorisation: 19 October 2009 Date of latest renewal: 19 October 2014
Datum prve odobritve: 19. oktober 2009 Datum zadnjega podaljšanja: 19. oktober 2014
However, the relevance for clinical protection is unknown.
Vendar pa pomen za klinično zaščito ni znan.
• Format of the simplified PSUR:
• Format za poenostavljeno poročilo PSUR:
- First data-lock point is 30 days later.
- Prvo zaključeno obdobje zbiranja podatkov je 30 dni pozneje.