natgillin/translations-raw huggingface dataset:
HOW TO STORE KIVEXA
SHRANJEVANJE ZDRAVILA KIVEXA
Keep Kivexa out of the reach and sight of children.
Zdravilo Kivexa shranjujte nedosegljivo otrokom!
Do not use Kivexa after the expiry date stated on the packaging.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
What Kivexa contains − The active substances are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine. − The other ingredients are magnesium stearate, microcrystalline cellulose, sodium starch glycollate, Opadry Orange YS-1-13065-A containing hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80 and sunset yellow aluminium lake (E110).
Opadry Orange YS- 1- 13065- A, ki vsebuje hipromelozo, titanov dioksid (E171), makrogol 400, polisorbat 80 in oranžno FCF (E110).
The tablets are orange, film-coated, capsule shaped, engraved with GS FC2 on one side.
Na eni strani imajo odtisnjeno oznako GS FC2.
They are provided in bottles or blister packs containing 30 tablets and blister packs containing 90 (3x30) tablets.
Na voljo so v plastenkah ali pretisnih omotih, ki vsebujejo 30 tablet in pretisnih omotih, ki vsebujejo 90 (3x30) tablet.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
40 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Tel: + 351 21 412 95 00 FI. PT@gsk. com
Tel.: + 48 (0) 22 576 9000 Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00 FI. PT@ gsk. com
This leaflet was approved in {MM/ YYYY}
Navodilo je bilo odobreno:
What is KOGENATE Bayer?
Kaj je zdravilo KOGENATE Bayer?
KOGENATE Bayer is a powder and solvent that are mixed together to make a solution for injection.
Zdravilo KOGENATE Bayer sestavljata prašek in vehikel, ki se zmešata v raztopino za injiciranje.
KOGENATE Bayer contains the active substance octocog alfa (recombinant coagulation factor VIII).
KOGENATE Bayer vsebuje zdravilno učinkovino oktokog alfa (rekombinantni koagulacijski faktor VIII).
What is KOGENATE Bayer used for?
Za kaj se zdravilo KOGENATE Bayer uporablja?
KOGENATE Bayer is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Zdravilo KOGENATE Bayer se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno motnjo strjevanja krvi zaradi pomanjkanja faktorja VIII).
KOGENATE Bayer is intended for either short-term or long-term use.
Zdravilo KOGENATE Bayer je namenjeno bodisi za kratkotrajno ali dolgotrajno uporabo.
How is KOGENATE Bayer used?
Kako se zdravilo KOGENATE Bayer uporablja?
KOGENATE Bayer should be started by a doctor who has experience in the treatment of haemophilia.
Zdravljenje z zdravilom KOGENATE Bayer mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
KOGENATE Bayer is given by intravenous injection (into a vein) over several minutes, up to a rate of 2 ml per minute.
Zdravilo KOGENATE Bayer se daje z intravensko injekcijo (v veno) v trajanju več minut s hitrostjo največ 2 ml na minuto.
The dose and frequency depend on whether KOGENATE Bayer is used to treat haemorrhage (bleeding) or prevent it during surgery.
Odmerek in pogostost odmerjanja zdravila sta odvisna od tega, ali se zdravilo KOGENATE Bayer uporablja za zdravljenje krvavitev ali pa za preprečevanje krvavitev med kirurškim posegom.
KOGENATE Bayer can also be given as a continuous infusion (drip into a vein) for at least seven days in patients undergoing major surgery.
Zdravilo KOGENATE Bayer se lahko daje tudi s kontinuirano infuzijo (kapalno infuzijo v veno) v trajanju najmanj sedem dni pri bolnikih, pri katerih je bil opravljen večji kirurški poseg.
How does KOGENATE Bayer work?
Kako zdravilo KOGENATE Bayer deluje?
The active substance in KOGENATE Bayer, octocog alfa, is a blood coagulation factor protein.
Zdravilna učinkovina v zdravilu KOGENATE Bayer, oktokog alfa, je beljakovinski krvni koagulacijski faktor.
KOGENATE Bayer is used to replace the missing factor VIII.
Z zdravilom KOGENATE Bayer se nadomesti manjkajoči faktor VIII.
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged KOGENATE Bayer given as an intravenous injection has been studied in 66 patients who had been previously treated with recombinant coagulation factor VIII and 61 children who had not.
Zdravilo KOGENATE Bayer je podobno zdravilu KOGENATE, vendar je za razliko od slednjega pripravljeno na drugačen način, in sicer tako, da ne vsebuje nobenih beljakovin človeškega izvora.
The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Zdravilo KOGENATE Bayer, vbrizgano z intravensko injekcijo, so preučili pri 66 bolnikih, ki so bili predhodno zdravljeni z rekombinatnim koagulacijskim faktorjem VIII, in pri 61 otrocih, ki z njim predhodno niso bili zdravljeni.
KOGENATE Bayer has also been studied as a continuous infusion in 15 patients with haemophilia A undergoing major surgery.
Zdravilo KOGENATE Bayer so preučili tudi ob dajanju tega zdravila v obliki kontinuirane infuzije pri 15 bolnikih s hemofilijo A, pri katerih je bil opravljen večji kirurški poseg.
What benefit has KOGENATE Bayer shown during the studies?
Kakšne koristi je zdravilo KOGENATE Bayer izkazalo med raziskavami?
In the previously treated patients, overall, 95% of bleeds responded to one or two intravenous injections of KOGENATE Bayer.
V celoti je pri predhodno zdravljenih bolnikih v 95% primerov krvavitev prišlo do odziva na eno do dve intravenski injekciji zdravila KOGENATE Bayer.
What is the risk associated with KOGENATE Bayer?
Kakšna tveganja so povezana z zdravilom KOGENATE Bayer?
In clinical trials with KOGENATE Bayer, this happened in 14% of previously untreated patients and in 17% of children who had been treated for less than five days in the past.
V kliničnih preizkušanjih zdravila KOGENATE Bayer je do tega prišlo pri 14% predhodno nezdravljenih bolnikov in pri 17% otrok, ki so bili v preteklosti zdravljeni manj kot pet dni.
However, it is seen in less than 0.2% of patients treated for more than 100 days.
Vendar pa so ta pojav opazili pri manj kot 0, 2% bolnikih, ki so bili zdravljeni več kot 100 dni.
If antibodies develop, KOGENATE Bayer will not work effectively.
Če se razvijejo protitelesa, zdravilo KOGENATE Bayer v takem primeru ni več učinkovito.
Other side effects seen in rare cases were dysgeusia (taste disturbances), nausea, reactions at the injection site, pyrexia (fever), allergic or anaphylactic (severe allergic) reactions, abnormal blood pressure, dizziness, pruritus (itching) and rash.
Ostali redko opaženi neželeni učinki so bili disgevzija (motnje okušanja), navzeja, reakcije na mestu injiciranja, pireksija (povišana telesna temperatura), alergične ali anafilaktične (hude alergične) reakcije, nenormalen krvni tlak, omotica, pruritus (srbenje) in izpuščaji.
KOGENATE Bayer should not be used in people who may be hypersensitive (allergic) to recombinant coagulation factor VIII, to mouse or hamster protein or to any of the other ingredients.
Zdravila KOGENATE Bayer ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) človeški koagulacijski faktor VIII, na beljakovine miši ali hrčka ali katerokoli drugo sestavino zdravila.
Why has KOGENATE Bayer been approved?
Zakaj je bilo zdravilo KOGENATE Bayer odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that KOGENATE Bayer’ s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila KOGENATE Bayer pri zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII) večje od z njim povezanih tveganj.
The Committee recommended that KOGENATE Bayer be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo KOGENATE Bayer odobri dovoljenje za promet z zdravilom.
Other information about KOGENATE Bayer:
Druge informacije o zdravilu KOGENATE Bayer:
The European Commission granted a marketing authorisation valid throughout the European Union for KOGENATE Bayer on 4 August 2000.
Evropska komisija je dovoljenje za promet z zdravilom KOGENATE Bayer, veljavno po vsej Evropski uniji, odobrila dne 4. avgusta 2000.
The full EPAR for KOGENATE Bayer is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo KOGENATE Bayer je na voljo tukaj.
Powder and solvent for solution for injection-
Prašek in vehikel za raztopino za injiciranje
Intravenous use-
Intravenska uporaba
powder: vial (glass); solvent: pre-filled syringe (glass)-
prašek: viala (steklo); vehikel: napolnjena brizga (steklo)
2.5 ml (100 IU/ ml)-
2. 5 ml (100 IU/ ml)
1 vial + 1 pre-filled syringe + 1 Bio-Set device**
1 viala + 1 napolnjena brizga + 1 pribor Bio- Set **
2.5 ml (200 IU/ ml)-
2. 5 ml (200 IU/ ml)
2.5 ml (400 IU/ ml)-
2. 5 ml (400 IU/ ml)
1 vial 1 pre-filled syringe 1 vial adapter**
1 viala + 1 napolnjena brizga + 1 adapter za vialo **
1 vial 1 pre-filled syringe 1 vial adapter**
1 viala + 1 napolnjena brizga + 1 adapter za vialo **.
5.0 ml (400 IU/ ml)-
5. 0 ml (400 IU/ ml)
1/ 2 * - 1 transfer device
1/ 2 * - 1 pribor za prenos vehikla
- 1 filter needle
- 1 filtrirna igla
- 1 plastic syringe (5 ml)
- 1 plastična brizga (5 ml)
- two sterile alcohol swabs for single use
- dva sterilna tampona z alkoholom za enkratno uporabo
** - 1 venipuncture set
** - 1 pribor za vensko punkcijo
- 2 dry swabs
- 2 suha tampona
- 2 plasters
- 2 obliža
KOGENATE Bayer 250 IU Powder and solvent for solution for injection.
KOGENATE Bayer 250 i. e. prašek in vehikel za raztopino za injiciranje
until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% b) By continuous infusion Raise factor VIII activity pre- surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/ Kg/ h) adjusting according to patient’ s daily clearance and desired factor VIII levels for at least 7 days.
Infuzijo ponovimo vsakih 8- 24 ur, dokler se rana ne zaceli; nato nadaljujemo z zdravljenjem vsaj še naslednjih 7 dni, tako da vzdržujemo aktivnost faktorja VIII na 30- 60%. b) s kontinuirano infuzijo Pred kirurškim posegom zvečamo aktivnost faktorja VIII z začetno bolusno infuzijo ter takoj nadaljujemo s kontinuirano infuzijo (i. e. / kg/ h), ki je prilagojena glede na bolnikov dnevni očistek in želene vrednosti faktorja VIII vsaj 7 dni.
It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative).
V klinični študiji pri odraslih bolnikih s hemofilijo A, pri katerih je bil opravljen večji kirurški poseg, se je pokazalo, da se zdravilo KOGENATE Bayer lahko uporablja kot kontinuirana infuzija pri kirurških posegih (pred -, med in po posegu).
KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Zdravilo KOGENATE Bayer kot pomožno snov vsebuje nizke količine polisorbata 80, za katerega je znano, da zveča hitrost ekstrakcije di - (2- etilheksil) ftalata (DEHP) iz polivinilkloridnih (PVC) materialov.
For scheduled prophylaxis against bleeds in patients with severe haemophilia A, doses of 20 to 60 IU of KOGENATE Bayer per kg body weight should be given at intervals of 2 to 3 days.
Za redno preprečevanje krvavitev pri bolnikih s hudo hemofilijo A naj bi se dajali odmerki od 20 do 60 i. e. zdravila KOGENATE Bayer na kg telesne mase vsake 2 do 3 dni.
If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Če je koncentracija inhibitorja manjša kot 10 Bethesda enot (BE) na mililiter, ga je možno nevtralizirati z dodatnim odmerkom rekombinantnega koagulacijskega faktorja VIII in nadaljevati klinično učinkovito zdraljenje z zdravilom KOGENATE Bayer.
Clearance:
hitrost infundiranja i. e. / h/ kg
Desired plasma FVIII level
100 i. e. / ml 200 i. e. / ml
Infusion rate IU/ h/ kg
400 i. e. / ml
Infusion rate for 75 kg patient ml/ h Concentrations of rFVIII solution 100 IU/ ml 200 IU/ ml 400 IU/ ml
100% (1 i. e. / ml) 60% (0, 6 i. e. / ml) 40% (0, 4 i. e. / ml)
100% (1 IU/ ml) 60% (0.6 IU/ ml) 40% (0.4 IU/ ml)
3. 0 1, 8 1, 2
3.0 1.8 1.2
2, 25 1, 125 1, 35 0, 68 0, 9 0, 45
2.25 1.125 0.56 1.35 0.68 0.34 0.9 0.45 0.225
0, 56 0, 34 0, 225
In the interest of the patients, it is recommended that, whenever possible, every time that KOGENATE Bayer is administered to them, the name and the batch number of the product is registered.
Zaradi interesa bolnikov je priporočljivo, da pri vsaki aplikaciji zdravila KOGENATE Bayer bolniku zabeležite ime in serijsko številko zdravila, če je mogoče.
No interactions of KOGENATE Bayer with other medicinal products are known.
Medsebojno delovanje zdravila KOGENATE Bayer z drugimi zdravili ni znano.
Animal reproduction studies have not been conducted with KOGENATE Bayer.
Ni študij o delovanju zdravila KOGENATE Bayer na reprodukcijo pri živalih.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer during pregnancy and breast-feeding is not available.
Hemofilija A je pri ženskah zelo redka.
Therefore, KOGENATE Bayer should be used during pregnancy and lactation only if clearly indicated.
Izkušenj o uporabi zdravila KOGENATE Bayer med nosečnostjo in dojenjem ni, zato ga med nosečnostjo in dojenjem uporabljamo le, če je to jasno indicirano.
KOGENATE Bayer has no influence on the ability to drive or to use machines.
KOGENATE Bayer ne vpliva na sposobnost vožnje in upravljanja s stroji.
After administration of KOGENATE Bayer mild to moderate adverse events were observed in rare cases as presented in the following table.
Po dajanju zdravila KOGENATE Bayer so redko opazili blage do zmerne neželene učinke, kot je prikazano v sledeči tabeli.
management of individuals with haemophilia A.
Kot zaplet pri zdravljenju hemofilije A se lahko pri bolnikih pojavijo protitelesa (inhibitorji) proti faktorju VIII.
In clinical studies, KOGENATE Bayer has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days).
V kliničnih študijah so KOGENATE Bayer uporabili za zdravljenje krvavitev pri 37 predhodno nezdravljenih bolnikih (PNB) in 23 minimalno zdravljenih pediatričnih bolnikih (MZB, kar je opredeljeno kot 4 dnevi izpostavljenosti ali manj).
The median number of exposure days at the time of inhibitor detection in these patients was 9 days (range 3 - 18 days).
Inhibitorji so se pojavili pri 5 od 37 (14%) PNB in pri 4 od 23 (17%) MZB zdravljenih z zdravilom KOGENATE Bayer: pri 6 od 60 (10%) s titrom večjim kot 10 BE in pri 3 od 60 (5%) s titrom manjšim kot 10 BE Mediana izpostavljenost v času odkritja inhibitorjev je bila pri teh bolnikih 9 dni (z razponom od 3 do 18 dni).
Less than 0.2% PTP developed de-novo inhibitors.
V obsežnih post- registracijskih raziskavah z zdravilom KOGENATE Bayer, ki so zajele več kot 1000 bolnikov, so ugotovili naslednje: inhibitorji so se de novo pojavili pri manj kot 0, 2% PZB.
The factor VIII/ von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Kompleks faktorja VIII in von Willebrandovega faktorja (vWF) je sestavljen iz dveh molekul (faktor VIII in vWF) z različnimi fiziološkimi funkcijami.
Activated factor VIII acts as a cofactor for activated factor
Aktiviran faktor VIII deluje kot kofaktor za aktivirani faktor IX in pospešuje pretvorbo faktorja X v aktiviran faktor X.
6 IX, accelerating the conversion of factor X to activated factor X.
Aktiviran faktor X pretvarja protrombin v trombin.
The degree and duration of aPTT normalisation observed after administration of KOGENATE Bayer is similar to that achieved with plasma-derived factor VIII.
Stopnja in trajanje normalizacije APTČ sta pri zdravilu KOGENATE Bayer podobna kot pri faktorju VIII, ki je pridobljen iz plazme.
The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2% per IU/ kg body weight for KOGENATE Bayer.
Iz analize podatkov o in vivo uporabnosti zdravila pri predhodno zdravljenih bolnikih z zdravilom KOGENATE Bayer so ugotovili, da 1 i. e. na kilogram telesne mase povprečno zviša aktivnost faktorja VIII za 2%.
Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/ h.
Dodatni farmakokinetični parametri za bolusno injekcijo zdravila KOGENATE Bayer so: povprečni čas zadrževanja [PČZ (0- 48)] je približno 22 ur, očistek pa je približno 160 ml/ h.
Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/ h corresponding to 3.0 ml/ h/ kg (range 1.6-4.6 ml/ h/ kg).
Povprečni začetni očistek pri 14- ih odraslih bolnikih pri katerih je bil narejen večji kirurški poseg in so dobili kontinuirano infuzijo, je 188 ml/ h, kar ustreza 3, 0 ml/ h/ kg (območje 1, 6- 4, 6 ml/ h/ kg).
No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.
Raziskave mutagenega poteciala zdravila KOGENATE Bayer niso bile narejene, ker pri predhodniku zdravila KOGENATE Bayer v in vitro in in vivo raziskavah niso opazili mutagenega delovanja.
Powder Glycine Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
7 histidin polisorbat 80 saharoza
This medicinal product must not be mixed with other medicinal products or solvents.
Zdravilo se ne sme mešati z drugimi zdravili ali vehikli.
Each package of KOGENATE Bayer contains: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey bromobutyl rubber blend stopper and aluminium seal) • one vial with solvent (10 ml clear glass type 2 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal) • an additional package with:
Vsako pakiranje zdravila KOGENATE Bayer vsebuje: • 1 vialo s praškom (10 ml viala iz prozornega stekla tipa 1, s sivim bromobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko) • 1 vialo z vehiklom (10 ml viala iz prozornega stekla tipa 2 s sivim klorobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko) • dodatno pakiranje, ki vsebuje:
- 1 transfer device
- 1 pribor za prenos vehikla
- 1 filter needle
- 1 filtrirno iglo
- 1 plastic syringe (5 ml)
- 1 plastično brizgo (5 ml)
- two sterile alcohol swabs for single use
- dva sterilna tampona prepojena z alkoholom za enkratno uporabo
Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.
Natančna navodila za pripravo in uporabo se nahajajo v navodilu za uporabo v vsakem pakiranju zdravila KOGENATE Bayer.
KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile transfer device.
Prašek KOGENATE Bayer lahko raztopite le v priloženem vehiklu (2, 5 ml vode za injekcije.
Reconstitution should be performed in accordance with good practices rules, particularly with attention to asepsis.
Rekonstitucijo je treba izvesti v skladu s pravili dobre prakse,
After reconstitution, the solution is drawn through the sterile filter needle into the sterile disposable syringe (both supplied).
Po rekonstituciji raztopino filtrirajte skozi sterilno filtrirno iglo v sterilno brizgo (igla in brizga sta priloženi).
KOGENATE Bayer 500 IU Powder and solvent for solution for injection.
KOGENATE Bayer 500 i. e. prašek in vehikel za raztopino za injiciranje
14 IX, accelerating the conversion of factor X to activated factor X.
Aktiviran faktor X pretvarja protrombin v trombin.
Powder Glycine Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
15 histidin polisorbat 80 saharoza
KOGENATE Bayer 1000 IU Powder and solvent for solution for injection.
KOGENATE Bayer 1000 i. e. prašek in vehikel za raztopino za injiciranje
Subsequent infusion rates should be calculated based on the actual FVIII levels and recalculated clearance for each day post surgery based on the equation: clearance = infusion rate/ actual FVIII level.
20 Naknadno se hitrost infundiranja izračuna na podlagi dejanske koncentracije FVIII in preračuna glede na očistek vsakodnevno po kiruršem posegu po naslednji enačbi: očistek = hitrost infundiranja/ dejanska koncentracija FVIII.
20 4.3 Contraindications
4. 3 Kontraindikacije
22 IX, accelerating the conversion of factor X to activated factor X.
Aktiviran faktor X pretvarja protrombin v trombin.
Powder Glycine Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
23 histidin polisorbat 80 saharoza
The solvent is water for injections provided in a pre-filled syringe.
Vehikel je voda za injekcije v napolnjeni injekcijski brizgi.
If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Če je koncentracija inhibitorja manjša kot 10 Bethesda enot (BE) na mililiter, ga je možno nevtralizirati z dodatnim odmerkom rekombinantnega koagulacijskega faktorja VIII in nadaljevati klinično učinkovito zdravljenje z zdravilom KOGENATE Bayer.
Administration Reconstitute the preparation as described in section 6.6.
Način uporabe Prašek rekonstituirajte, kot je opisano v poglavju 6. 6.
2 ml/ min).
Hitrost injiciranja naj bo prilagojena bolnikovemu počutju (največja dovoljena hitrost injiciranja je 2 ml/ min).
If allergic or anaphylactic reactions occur, the injection/ infusion should be stopped immediately and the patient should contact their physician.
Če pride do alergijske ali anafilaktične reakcije, je treba injiciranje/ infundiranje takoj ustaviti in bolniki se morajo posvetovati z zdravnikom.
In a clinical study about the use of continuous infusion in surgeries, heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
Zaradi interesa bolnikov je priporočljivo, da pri vsaki aplikaciji zdravila KOGENATE Bayer bolniku zabeležite ime in serijsko številko zdravila, če je mogoče.
However, the possibility of allergic reactions to constituents, e. g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see section 4.3 and 4.4).
Kljub temu pa pri nekaterih bolnikih obstaja možnost alergijskih reakcij na sestavine zdravila, npr. na sledove beljakovin miši in hrčkov (glejte poglavji 4. 3 in 4. 4).
When infused into a haemophiliac patient, factor VIII
Kompleks faktorja VIII in von Willebrandovega faktorja (vWF) je sestavljen iz dveh molekul (faktor VIII in vWF) z različnimi fiziološkimi funkcijami.
30 binds to vWF in the patient’ s circulation.
Po injiciranju faktorja VIII v krvni obtok bolnika s hemofilijo se le- ta veže na vWF.
Powder Glycine Sodium chloride Calcium chloride Histidine Polysorbate 80 Sucrose
31 histidin polisorbat 80 saharoza
Only the provided components (powder vial with Bio-Set device, pre-filled syringe containing solvent and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Če se uporabi drug pribor, je lahko zdravljenje zaradi adsorpcije humanega faktorja strjevanja krvi VIII na notranje stene nekaterih priborov za injiciranje neuspešno.