natgillin/translations-raw huggingface dataset:
However, in the presence of an inhibitor the doses required are variable and must be adjusted according to clinical response and monitoring of plasma factor VIII activity.
Ob prisotnosti inhibitorja je treba odmerek zdravila prilagajati glede na klinični odgovor in spremljati aktivnost faktorja VIII v plazmi.
Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
12 - 24 ur, 3 - 4 dni ali več, dokler ne izgine bolečina in se stanje ne izboljša.
Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 exposure days.
Pri 5 od 37 (14 %) predhodno nezdravljenih bolnikih in pri 4 od 23 (17 %) minimalno zdravljenih bolnikih, ki so se zdravili z zdravilom Helixate NexGen, so inhibitorji nastali v 20 dneh izpostavljenosti, Na splošno so pri 9 od 60 (15 %) bolnikov nastali inhibitorji.
It is recommended that every time that you use Helixate NexGen, the name and batch number of the product are documented.
Priporoča se, da vsakič po uporabi zdravila Helixate NexGen zabeležite ime in številko serije zdravila.
In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C < 2 IU/dl.
V kliničnih študijah so zdravilo Helixate NexGen uporabili za zdravljenje krvavitev pri 37 predhodno nezdravljenih bolnikih in 23 minimalno zdravljenih pediatričnih bolnikih (MTP - minimally treated patient, kar pomeni, da so bili izpostavljeni 4 dni ali manj) z rezidualnim faktorjem VIII: c < 2 i.e./dl.
Filtering is achieved by using the Mix2Vial adapter.
Pri filtriranju je treba uporabiti adapter Mix2vial.
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 Helixate NexGen.
Če je vsebnost 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 Helixate NexGen.
In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
V nekaterih primerih, še posebej pri mlajših bolnikih, morajo biti presledki med odmerki krajši ali pa odmerki večji.
In extensive post-registration observational studies with Helixate NexGen, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors.
V obsežnih poregistracijskih opazovalnih študijah z zdravilom Helixate NexGen, v katere je bilo vključenih več kot 1000 bolnikov, so ugotovili naslednje: inhibitorji so de novo nastali pri manj kot 0,2 % predhodno zdravljenih bolnikih.
• If for the administration of Helixate NexGen you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
• Če je za vnos zdravila Helixate NexGen potreben centralni venski kateter (CVK), mora vaš zdravnik upoštevati možnost zapletov, povezanih s CVK, kot so lokalne okužbe, prisotnost bakterij v krvi (bakteriemija) in nastanek krvnih strdkov v krvnih žilah (tromboza) na mestu vstavitve katetra.
For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir.
Za kontinuirano infuzijo so klinično in in vitro stabilnost prikazali z uporabo premičnih črpalk s PVC
Determine the point of injection and prepare antiseptically.
Določite mesto injiciranja in ga dezinficirajte.
After administration of Helixate NexGen, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Po dajanju zdravila Helixate NexGen se maksimalna aktivnost faktorja VIII zmanjšuje dvofazno eksponentno, razpolovni čas je približno 15 ur.
Marketing Authorisation Holder Bayer Pharma AG 13342 Berlin Germany
Imetnik dovoljenja za promet Bayer Pharma AG 13342 Berlin
Hold the syringe upright and push the plunger until no air is left in the syringe.
Brizgo držite pokončno in potiskajte bat toliko časa, da v brizgi ne bo več zraka.
• dysgeusia
• disgevzija
In clinical studies with 73 previously treated patients (PTP, defined as having ≥100 exposure days), followed over 4 years, no de-novo inhibitors were observed.
V kliničnih študijah pri 73 predhodno zdravljenih bolnikih (kar pomeni, da so bili izpostavljeni več kot 100 dni), ki so jih spremljali štiri leta, niso ugotovili de novo nastanka inhibitorjev.
In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with Helixate NexGen (followed up to 75 exposure days).
V eni opazovalni študiji je bila incidenca nastanka inhibitorja pri uporabi zdravila Helixate NexGen pri predhodno nezdravljenih bolnikih s hudo hemofilijo A 64/183 (37,7 %) (spremljali so bolnike, ki so bili izpostavljeni do 75 dni).
Haemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-haemophilic patients when clotting has been normalised by treatment with FVIII.
Pri hemofilikih z dejavniki tveganja za srčnožilne bolezni ali s srčnožilnimi boleznimi obstaja enako tveganje za nastanek srčnožilnih bolezni kot pri bolnikih, ki nimajo hemofilije, ko je bilo strjevanje krvi normalizirano z zdravljenjem s faktorjem VIII.
Concentrations of rFVIII solution 100 IU/ml 200 IU/ml 400 IU/ml
3 ml/h/kg koncentracije raztopin rFVIII 100 i.e./ml 200 i.e./ml 400 i.e./ml
Inhibitor development in previously untreated and treated patients (PUPs / PTPs) has been reported (see section 4.4).
previously untreated patient / PTP - previously treated patient) (glejte poglavje 4.4).
Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5
Potrebni odmerek (i.e.) = telesna masa (kg) × želeni dvig aktivnosti faktorja VIII (% normalne vrednosti) × 0,5
Patients should be monitored for the development of factor VIII inhibitors.
Pri bolnikih je treba spremljati ali je prišlo do nastanka inhibitorjev faktorja VIII.
Blood and the Lymphatic System Disorders
Bolezni krvi in limfatičnega sistema nastanek inhibitorjev proti FVIII
• formation of neutralising antibodies to factor VIII (inhibitors) in previously untreated patients
• nastanek nevtralizirajočih protiteles proti faktorju VIII (inhibitorjev) pri predhodno nezdravljenih bolnikih
One patient was lost to follow up and one patient developed a low-titre inhibitor during post study follow-up.
Enega bolnika niso spremljali, pri enem pa so je med spremljanjem po študiji ugotovili nastanek nizkega titra inhibitorjev.
Use only the medical devices for reconstitution and administration that are provided with each package of this medicine.
Za rekonstitucijo in injiciranje tega zdravila lahko uporabite samo pribor, ki je priložen v vsakem pakiranju zdravila.
16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
Pustite, da kri teče nazaj k odprtemu koncu pribora za punkcijo vene in nato pritrdite brizgo z raztopino.
Data show that Helixate NexGen has been used to induce immune tolerance.
Podatki kažejo, da se zdravilo Helixate NexGen uporablja za indukcijo imunske tolerance.
If you are unsure about this, ask your doctor.
Če glede navedenega niste prepričani, se posvetujte s svojim zdravnikom.
Read the package leaflet before use.
POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
Helixate NexGen 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 Helixate NexGen kot pomožno snov vsebuje majhno količino polisorbata 80, za katerega je znano, da zveča hitrost ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materialov.
With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces.
Z eno roko primite komplet Mix2Vial na strani kjer je zdravilo, z drugo roko pa na strani kjer je vehikel in razstavite komplet na dva dela.
• formation of neutralising antibodies to factor VIII (inhibitors) in previously treated patients
• nastanek nevtralizirajočih protiteles proti faktorju VIII (inhibitorjev) pri predhodno zdravljenih bolnikih
• If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine.
• Če imate občutek tiščanja v prsih, vrtoglavico, omedlevico, občutek siljenja na bruhanje ali ste omotični kadar stojite, je možno, da imate redko, hudo nenadno alergijsko reakcijo (t.i. anafilaktično reakcijo).
Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for Helixate NexGen in laboratory animals (mouse, rat, rabbit, and dog).
Tudi pri dajanju odmerkov, ki so bili nekajkrat večji od priporočenega kliničnega odmerka (glede na telesno maso) pri različnih laboratorijskih živalih (miš, podgana, kunec in pes) niso opazili nobenih akutnih ali subakutnih toksičnih učinkov zdravila Helixate NexGen.
Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Potek zdravljenja teh bolnikov mora voditi zdravnik z izkušnjami v zdravljenju hemofilije in uporabe inhibitorjev faktorja VIII.
May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label.
Zdravilo lahko do 12 mesecev shranjujete pri temperaturi do 25 °C do navedenega datuma izteka roka uporabnosti.
Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Vzemite Mix2Vial skupaj s pretisnim omotom in potisnite konico modrega adapterja naravnost navzdol skozi zamašek viale z vehiklom.
• one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
• 1 vialo s praškom (10 ml viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
Helixate NexGen can be infused by continuous infusion.
Helixate NexGen se lahko uporabi kot kontinuirana infuzija.
• one vial with solvent (6 ml clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
• 1 vialo z vehiklom (6 ml viala iz prozornega stekla tipa 1 s sivim klorobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
Place the solvent vial on an even, clean surface and hold the vial tight.
Postavite vialo z vehiklom na ravno, čisto površino in jo trdno primite.
The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).
Aktivnost zdravila (i.e.) se ugotavlja z enostopenjskim preizkusom strjevanja krvi, v primerjavi z FDA mega-standardom, ki je bil umerjen v mednarodnih enotah (i.e.) glede na standard SZO.
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Količine faktorja VIII, potrebne za zdravljenje, so izražene v mednarodnih enotah (i.e.), ki so določene s standardom SZO za faktor VIII.
• If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
• Če je pri vas že kdaj prišlo do nastanka inhibitorjev faktorja VIII, obstaja pri zamenjavi enega zdravila s faktorjem VIII z drugim zdravilom s faktorjem VIII, tveganje za ponovni nastanek inhibitorjev.
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
Systemic Hypersensitivit y reactions (including anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)
sistemske preobčutljivostn e reakcije (tudi anafilaksija, navzea, nenormalen krvni tlak in omotica)
Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma).
(glede na normalno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
• hypersensitivity reactions including severe sudden allergic reaction (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or anaphylactic shock, e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)
navzeo, koprivnico, angioedem, mrzlico, vročinski obliv, glavobol, letargijo, sopenje ali težave z dihanjem, nemir, tahikardijo, ščemenje ali anafilaktični šok, npr. tiščanje v prsnem košu/splošno slabo počutje, omotica, občutek siljenja na bruhanje in blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar stojite) • zvišana telesna temperatura
For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).
Za izračun hitrosti infundiranja v ml/h se hitrost infundiranja i.e./h/kg pomnoži s kg telesne mase/koncentracija raztopine (i.e./ml).
The dose, frequency and duration of the substitution therapy must be individualised according to the patient's needs (weight, severity of disorder of the haemostatic function, the site and extent of the bleeding, the presence of inhibitors, and the factor VIII level desired).
Odmerek, pogostnost in trajanje nadomestnega zdravljenja je treba prilagoditi potrebam posameznega bolnika (odvisno od telesne mase, stopnje motnje strjevanja krvi, mesta in obsega krvavitve, prisotnosti inhibitorjev in od želenega dviga aktivnosti faktorja VIII).
It is strongly recommended that every time that Helixate NexGen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Priporočljivo je, da se po vsaki uporabi zdravila Helixate NexGen zabeležita ime in serijska številka zdravila, da je mogoča povezava med bolnikom in serijo zdravila, ki ga je prejel.
Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe.
Sedaj ko je raztopina v brizgi, trdno primite brizgo (bat brizge naj gleda navzdol) in odstranite prozoren Mix2Vial adapter z brizge.
After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied).
Po rekonstituciji raztopino filtrirajte skozi pribor za prenos vehikla Mix2Vial s filtrom v sterilno brizgo (igla in brizga sta priloženi).
After reconstitution, the product must be used within 3 hours.
Zdravilo je treba po rekonstituciji uporabiti v 3 urah.
He/she should always adjust the amount of this medicine to be administered and the frequency of administration according to your individual needs.
Zdravnik mora odmerek in pogostost dajanja odmerka tega zdravila prilagoditi glede na vaše individualne potrebe.
By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
S tem se začasno popravi pomanjkanje faktorja VIII in se zmanjša nagnjenost h krvavitvam.
The degree and duration of aPTT normalisation observed after administration of Helixate NexGen is similar to that achieved with plasma-derived factor VIII.
Stopnja in trajanje normalizacije APTČ sta pri zdravilu Helixate NexGen podobna kot pri faktorju
• local reactions where you injected the medication (e.g. burning sensation, temporary redness)
• lokalne reakcije na mestu injiciranja (npr. pekoča bolečina, prehodna rdečica)
Therefore, Helixate NexGen should be used during pregnancy and breast-feeding only if clearly indicated.
Izkušenj o uporabi zdravila Helixate NexGen med nosečnostjo in dojenjem ni, zato ga med nosečnostjo in dojenjem uporabljamo le, če je to jasno indicirano.
1 vial with 5.0 ml water for injections.
OVOJNINAH VIALA S 5,0 ML VODE ZA INJEKCIJE
Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)
Bolezni imunskega sistema preobčutljivos tne kožne reakcije (pruritus, urtikatija in osip)
Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII.
Pri bolnikih s hemofilijo A lahko nastanejo nevtralizirajoča protitelesa (inhibitorji) proti faktorju VIII.
Elevation of FVIII levels following administration, in particular with existing cardiovascular risk factors, might put a patient into the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
zlasti v primeru obstoječih srčnožilnih dejavnikov tveganja, predstavlja pri bolniku najmanj enako tveganje za zaporo žil ali miokardni infarkt kakor pri populaciji, ki nima hemofilije.
If this dose does not control your bleeding your doctor may consider giving you an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate.
se lahko vaš zdravnik odloči za dodatno zdravilo, koncentrat faktorja VIIa ali koncentrat (aktiviranega) protrombinskega kompleksa.
1 vial with 2.5 ml water for injections.
OVOJNINAH VIALA S 2,5 ML VODE ZA INJEKCIJE
However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion".
V in vitro študijah je bilo zdravilo v PVC vrečkah, pripravljeno za kontinuirano infuzijo, pri temperaturi 30 °C kemijsko in fizikalno stabilno 24 ur.
No studies were performed on the mutagenic potential of Helixate NexGen, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of Helixate NexGen.
Študije mutagenega poteciala zdravila Helixate NexGen niso bile narejene, ker pri predhodniku zdravila Helixate NexGen v in vitro in in vivo študijah niso opazili mutagenega delovanja.
Solvent: water for injection, a clear, colourless solution.
Vehikel: voda za injekcije, bistra, brezbarvna raztopina Rekonstituirano zdravilo je bistra in brezbarvna raztopina.
Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen.
Natančna navodila za pripravo in uporabo so v navodilu za uporabo ki je priložen zdravilu, Helixate
The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).
Hitrost injiciranja naj bo prilagojena počutju bolnika (največja hitrost injiciranja je 2 ml/min).
For major surgery in particular, close monitoring of the substitution therapy by means of coagulation analysis must be carried out.
Predvsem pri večjih kirurških posegih je nujno potek nadomestnega zdravljenja skrbno spremljati z analizo strjevanja krvi.
It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
se je pokazalo, da se zdravilo Helixate NexGen lahko uporablja kot kontinuirana infuzija pri kirurških posegih (pred, med in po posegu).
Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII.
Indukcija imunske tolerance (ITI - Immune Tolerance Induction) Podatke o indukciji imunske tolerance so zbrali pri bolnikih s hemofilijo A, pri katerih so nastali inhibitorji faktorja VIII.
Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Vialo z zdravilom s prozornim adapterjem nežno obračajte dokler se prašek popolnoma ne raztopi.
Do not use solutions containing visible particles or that are cloudy.
Ne uporabljajte raztopin z vidnimi delci ali motnih raztopin.
Puncture the vein and secure the venipuncture set with a plaster.
Punktirajte veno in z obližem pritrdite pribor za punkcijo vene.
When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation.
Po injiciranju faktorja VIII bolniku s hemofilijo se faktor VIII v krvnem obtoku veže na vWF.
Helixate NexGen has no influence on the ability to drive or to use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Helixate NexGen nima vpliva na sposobnost vožnje in upravljanja s stroji.
Discard the solvent vial with the blue Mix2Vial adapter attached.
Vialo z vehiklom z modrim adapterjem Mix2Vial zavrzite.
Cases of recurrence of inhibitors (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Pri zamenjavi enega rekombinantnega faktorja VIII z drugim so pri predhodno zdravljenih bolnikih, ki so bili že več kot 100 dni izpostavljeni zdravilu in so imeli v anamnezi nastanek inhibitorjev, opazili primere ponovnega nastanka inhibitorjev (nizek titer).
Animal reproduction studies have not been conducted with Helixate NexGen.
Študij na živalih o vplivu zdravila Helixate NexGen na sposobnost razmnoževanja ni na voljo.
During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
V študijah niso pri nobenem od bolnikov opazili klinično pomembnih titrov protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
Only the provided administration sets can be used because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Če se uporabi drug pribor je lahko zdravljenje zaradi adsorpcije humanega rekombinantnega faktorja strjevanja krvi VIII na notranje stene nekaterih priborov za injiciranje neuspešno.
Expected factor VIII rise (% of normal) = 2 × administered IU body weight (kg)
Pričakovani dvig aktivnosti faktorja VIII (% normalne vrednosti) = 2 × dani odmerek (i.e.)
• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
Powder: dry white to slightly yellow powder or cake.
Prašek: suh bel do rahlo rumen prašek ali pogača
During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
V kliničnih preskušanjih pri nobenem izmed bolnikov niso opazili klinično pomembnega nastanka protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
In such cases, it is recommended that a specialised haemophilia centre be contacted.
V takih primerih se priporoča posvetovanje z zdravstvenim osebjem, ki je specializirano za obravnavo hemofilije.
After reconstitution, the chemical and physical in-use stability has been demonstrated for 3 hours in in vitro studies.
V in vitro študijah je bilo po rekonstituciji zdravilo kemijsko in fizikalno stabilno 3 ure.
If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for the presence of factor VIII inhibitor should be performed.
Če pričakovane aktivnosti faktorja VIII v plazmi niso dosežene ali če krvavitve z ustreznim odmerkom ni mogoče nadzirati, je treba opraviti preiskave glede prisotnosti inhibitorjev faktorja VIII.