natgillin/translations-raw huggingface dataset:
b) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of ADVATE following surgery (postoperative days 10-14).
Nepričakovano znižanje koncentracije koagulacijskega faktorja VIII se je pojavilo pri enem bolniku med neprekinjeno infuzijo zdravila ADVATE po operaciji (pooperativni dnevi 10 - 14).
If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Če aktivnost faktorja VIII ne doseže pričakovane ravni v plazmi ali če krvavitve z ustreznim odmerkom ne zaustavite, morate opraviti test prisotnosti zaviralca faktorja VIII.
• Do not use after the expiry date stated on the labels and carton.
• Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
It is strongly recommended that every time ADVATE 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.
Močno priporočamo, da vsakič, ko bolnik prejme zdravilo ADVATE, zabeležite ime in serijsko številko zdravila, da ohranite povezavo med bolnikom in serijo zdravila.
However, no correlating adverse histopathological changes could be observed indicating a transient nature of this finding.
Povezanih neželenih histopatoloških sprememb niso ugotovili, kar kaže na prehodno naravo omenjenega neželenega učinka.
Data on Immune Tolerance Induction (ITI) in patients with inhibitors have been collected.
Zbrali so podatke o indukciji imunske tolerance (ITI) pri bolnikih z zaviralci.
If central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Če je potreben centralni venski dostop (CVAD), tveganja zapletov, povezanih s CVAD, obsegajo lokalne okužbe, bakteriemijo in trombozo mesta katetra.
Factor VIII is necessary for the blood to form clots and stop bleedings.
Faktor VIII je potreben za strjevanje krvi in zaustavljanje krvavitev.
Insert the white plastic spike through the ADVATE powder stopper.
Vstavite belo plastično konico skozi zamašek praška ADVATE.
Do not remove the device from the package.
Pripomočka ne smete vzeti iz škatle.
In study 060201 two long-term prophylaxis treatment schemes have been compared in 53 PTPs: an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) with a standard prophylactic dosing regimen (20 to 40 IU/kg every 48 ±6 hours, n=30).
V študiji 060201 so primerjali dve dolgoročni shemi preventivnega zdravljenja pri 53 predhodno že zdravljenih osebah (PTP): prilagojen režim odmerjanja na osnovi farmakokinetične analize (razpon od 20 to 80 i.e. faktorja VIII na kg telesne mase v presledkih po 72 ± 6 ur, n = 23) in standardni režim preventivnega odmerjanja (od 20 do 40 i.e./kg vsakih 48 ± 6 ur, n = 30).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Ena internacionalna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru normalne človeške plazme.
Related to central venous access devices (CVAD) catheter-related infection, systemic infection and local blood clot at the catheter site.
V zvezi s centralnim venskim dostopom (CVAD) s katetrom povezane okužbe, sistemska okužba in lokalni krvni strdek na mestu katetra.
The vacuum will draw the solvent into the ADVATE powder vial (Fig. c).
Vakuum bo povlekel vehikel v vialo s praškom ADVATE (slika c).
ADVATE is usually injected into a vein (intravenously) by your doctor or nurse.
Zdravilo ADVATE bolniku običajno injicira v veno (intravensko) zdravnik ali medicinska sestra.
Children and adolescents The listed warnings and precautions apply to both adults and children (from 0 to 18 years of age).
Otroci in mladostniki Navedena opozorila in previdnostni ukrepi veljajo za odrasle in otroke (stare med 0 in 18 let).
Use in children and adolescents (from 0 to 18 years of age) For the treatment of bleeding the dosing in children does not differ from adult patients.
Uporaba pri otrocih in mladostnikih (starih med 0 in 18 let) Pri zdravljenju krvavitev se odmerjanje pri otrocih ne razlikuje od odmerjanja pri odraslih bolnikih.
The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Odmerek zdravila in trajanje nadomestne terapije sta odvisna od stopnje pomanjkanja faktorja VIII, mesta in obsega krvavitve ter od bolnikovega kliničnega stanja.
The pharmacokinetic guided dosing regimen (according to a specific formula) was targeted to maintain factor VIII trough levels ≥ 1% at the inter-dosing interval of 72 hours.
Namen ciljanega režima odmerjanja na osnovi farmakokinetične analize (po posebni formuli) je bil ohranitev koncentracije faktorja VIII ≥ 1 % pri presledku med odmerkoma 72 ur.
If you stop using ADVATE Do not stop using ADVATE without consulting your doctor.
Če ste prenehali uporabljati zdravilo ADVATE Ne prenehajte uporabljati zdravila ADVATE, ne da bi se prej posvetovali s svojim zdravnikom.
What you need to know before you use ADVATE
Kaj morate vedeti, preden boste uporabili zdravilo ADVATE
These symptoms can constitute an early symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
To so lahko zgodnji znaki anafilaktičnega šoka, med njegove znake pa sodijo še skrajna omotičnost, izguba zavesti in izjemno hude težave z dihanjem.
No symptoms of overdose with recombinant coagulation factor VIII have been reported.
Ni poročil o simptomih prevelikega odmerjanja rekombinantnega koagulacijskega faktorja VIII.
Clinical studies with ADVATE included 418 subjects with at least one exposure to ADVATE reporting in total 93 adverse drug reactions (ADRs).
V klinične raziskave z zdravilom ADVATE je bilo vključenih 418 preiskovancev, ki so vsaj enkrat prejeli zdravilo ADVATE, skupaj pa so poročali o 93 neželenih učinkih zdravila.
If you inject more ADVATE than recommended, tell your doctor as soon as possible.
Če injicirate večji odmerek zdravila ADVATE, kot je priporočeno, čimprej obvestite svojega zdravnika.
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.
Posebej pri večjih kirurških posegih je nepogrešljivo natančno spremljanje nadomestne terapije s testiranjem plazemske aktivnosti faktorja VIII.
d) Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Pogostnost temelji na študijah z vsemi zdravili s FVIII, ki so vključevale bolnike s hudo hemofilijo A. PZB = predhodno zdravljeni bolniki, PNB = predhodno nezdravljeni bolniki.
Reconstitution with the BAXJECT III system - Do not use if the lid is not completely sealed on the blister
Rekonstitucija s sistemom BAXJECT III - Zdravila ne uporabite, če pokrovček ni popolnoma zapečaten na pretisnem omotu.
After reconstitution, from a microbiological point of view, the product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
• Do not use if the lid is not completely sealed on the blister
• Zdravila ne uporabite, če pokrovček ni popolnoma zapečaten na pretisnem omotu.
ADVATE has no influence on the ability to drive and use machines.
Zdravilo ADVATE ne vpliva na sposobnost vožnje in upravljanja s stroji.
If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15 °C and 25 °C).
Če je zdravilo še vedno shranjeno v hladilniku, vzemite tako ADVATE prašek kot viale vehikla iz hladilnika in pustite, da se segrejejo na sobno temperaturo (med 15 in 25 °C).
• Do not try to administer the injection unless you have received special training from your doctor or nurse.
• Injekcije si ne smete dati, če vas zdravnik ali medicinska sestra nista posebej izurila za to.
Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Pri posameznih bolnikih je lahko odziv na faktor VIII različen, zato dosežemo različne vrednosti faktorja in vivo in različne razpolovne dobe.
What ADVATE is and what it is used for What you need to know before you use ADVATE How to use ADVATE
Kaj je zdravilo ADVATE in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ADVATE Kako uporabljati zdravilo ADVATE Možni neželeni učinki
In case of administration by a non health care professional appropriate training is needed.
Če ga daje oseba, ki ni zdravstveni delavec, mora biti ustrezno usposobljena za to.
Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Hudi simptomi, na primer težave z dihanjem in (skorajšnja) omedlevica, pa zahtevajo takojšnje urgentno zdravljenje.
If you or your child's bleeding is not being controlled with ADVATE, tell your doctor immediately.
Če krvavitev pri vas ali vašem otroku z zdravilom ADVATE ni obvladana, morate to nemudoma povedati zdravniku.
The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Klinični pomen nastanka zaviralcev je odvisen od titra zaviralca, pri čemer zaviralci z nizkim titrom, ki so prisotni le prehodno ali imajo stalno nizek titer, pomenijo manjše tveganje za nezadosten klinični odziv kot zaviralci z visokim titrom.
Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to the international standard for factor VIII in plasma).
Aktivnost faktorja VIII v plazmi izražamo bodisi v odstotkih (glede na normalno človeško plazmo) ali pa v i.e. (glede na mednarodni standard za faktor VIII v plazmi).
If you have the impression that the effect of ADVATE is insufficient, talk to your doctor.
Če menite, da je učinek zdravila ADVATE nezadosten, se posvetujte z zdravnikom.
Open the ADVATE package by peeling away the lid.
Odprite pakiranje zdravila ADVATE tako, da odlepite pokrov.
For on demand treatment dosing in paediatric patients (0 to 18 years of age) does not differ from adult patients.
Pri zdravljenju po potrebi se odmerjanje pri pediatričnih bolnikih (starih med 0 in 18 let) ne razlikuje od odmerjanja pri odraslih.
If the product is still stored in a refrigerator, take the sealed blister (contains powder and solvent vials preassembled with the system for reconstitution) from the refrigerator and let it reach room temperature (between 15 °C and 25 °C).
Če je zdravilo še vedno shranjeno v hladilniku, iz hladilnika vzemite zapečaten pretisni omot (vsebuje viali s praškom in vehiklom, ki sta že sestavljeni v sistem za rekonstitucijo) in počakajte, da se ogreje na sobno temperaturo (med 15 °C in 25 °C).
Other medicines and ADVATE Tell your doctor if you are using, have recently used or might use any other medicines.
Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
More extensive haemarthrosis, muscle bleeding or haematoma.
Obsežnejša hemartroza, krvavitev v mišico ali hematom
The following table 2 provides the frequency of adverse drug reactions in clinical trials and from spontaneous reporting.
Preglednica 2 spodaj prikazuje pogostnost neželenih učinkov zdravila v kliničnih preskušanjih in v spontanih poročilih.
Uncommon side effects (may affect up to 1 in 100 people) Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment)), dizziness, flu, fainting, abnormal heartbeat, red itchy bumps on the skin, chest discomfort, injection site bruise, injection site reaction, itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, sore throat, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, reduced percentage of red blood cells, increase in a type of white blood cells (monocytes), and pain in the upper abdomen or lower chest.
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) Zaviralci faktorja VIII (pri bolnikih, ki so se predhodno zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni)), omotica, gripa, omedlevica, nenormalen srčni ritem, rdeče in srbeče bulice na koži, neugodje v prsih, modrica na mestu injiciranja, reakcija na mestu injiciranja, srbenje, povečano potenje, neobičajen okus v ustih, navali vročine, migrene, motnje spomina, mrzlica, driska, slabost, bruhanje, težko dihanje, vnetje žrela, okužba limfatičnega žilja, bela koža, vnetje očesa, izpuščaji, prekomerno potenje, otekanje stopal in nog, zmanjšan odstotek rdečih krvničk, povečano število določene vrste belih krvničk (monocitov) in bolečine v zgornjem delu trebuha oziroma spodnjem delu prsi.
During the course of treatment, appropriate determination of plasma factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Med zdravljenjem je priporočljivo določanje vrednosti faktorja VIII v plazmi kot vodilo pri odmerjanju in določanju pogostosti ponavljanja injekcij.
Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE.
Preobčutljivostne reakcije alergijskega tipa, vključno z anafilakso, so bile ugotovljene pri zdravilu ADVATE.
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, acute toxicology, repeated dose toxicity, local toxicity and genotoxicity.
Neklinični podatki na osnovi študij farmakološke varnosti, akutne toksičnosti, toksičnosti pri ponavljajočih se odmerkih, lokalne toksičnosti in genotoksičnosti ne kažejo posebnega tveganja za človeka.
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Nastanek protiteles, ki nevtralizirajo faktor VIII (zaviralci), je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti zaviralci so ponavadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v enotah Bethesda (B.e.) na ml plazme z uporabo prilagojenega testa.
The frequency of administration will depend on how well ADVATE is working for you.
Pogostnost uporabe zdravila je odvisna od tega, kako učinkovito je zdravilo ADVATE pri vas.
Retrospective chart review was done for 30 paediatric subjects on ITI (in study 060703).
Pri 30 pediatričnih preiskovancih z ITI (v študiji 060703) so opravili retrospektivni pregled kartotek.
Intravenous use, after reconstitution.
Intravenska uporaba po rekonstituciji.
Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
Posesajte rekonstituirano raztopino v brizgo s počasnim vlečenjem bata nazaj (slika e).
Treatment with ADVATE will be started by a doctor who is experienced in the care of patients with haemophilia A.
Zdravljenje z zdravilom ADVATE vam bo uvedel zdravnik, ki je izkušen v zdravljenju bolnikov s hemofilijo A.
Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in side effects were noted in the clinical studies.
Razen nastanka zaviralcev pri predhodno nezdravljenih pediatričnih bolnikih in zapletov, povezanih s katetrom, v kliničnih raziskavah niso opazili starostno specifičnih razlik v neželenih učinkih.
Haemostasis was maintained at all times during this period and both plasma factor VIII levels and clearance rates returned to appropriate levels by postoperative day 15.
Hemostaza je bila ohranjena ves čas in do 15 dneva po operaciji sta se koncentracija plazemskega faktorja VIII in nivo očistka vrnila na ustrezno raven.
The product contains traces of mouse and hamster proteins.
Zdravilo vsebuje mišje oz. hrčkove beljakovine v sledovih.
For ADVATE reconstituted with 2 ml sterilised water for injections, misapplication (intra-arterially or paravenously) may lead to mild, short term injection site reactions, such as bruising and erythema.
Pri zdravilu ADVATE, rekonstituiranem v 2 ml sterilne vode za injekcije, lahko napačna (intraarterijska ali paravenska) uporaba povzroči blage, kratkotrajne reakcije na mestu injiciranja, kot sta podplutba in eritem.
The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl.
Izračun potrebnega odmerka faktorja VIII sloni na empirični ugotovitvi, da 1 i.e. faktorja VIII na kilogram telesne mase poveča plazemsko aktivnost faktorja VIII za 2 i.e./dl.
Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.
Testi za zaviralce faktorja VIII so bili negativni tako po zaključku neprekinjene infuzije kot po zaključku raziskave.
Required units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Potrebno število enot (i.e.) = telesna masa (kg) x želeno zvišanje faktorja VIII (%) x 0,5
• Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration as indicated by the symbol: • Do not refrigerate the solution after preparation.
• Zdravila ne uporabljajte, če so pripomoček BAXJECT II, njegov sterilen pregradni sistem ali njegova ovojnina poškodovani ali kažejo kakršnekoli znake kvarjenja, kar je označeno s simbolom: • Raztopine po pripravi ne shranjujte v hladilniku.
In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.
Pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII) faktorja VIII ni ali pa ne deluje pravilno.
If you are unsure about this, ask your doctor.
Če o tem niste prepričani, se posvetujte z zdravnikom.
The number of units of factor VIII is expressed in International Units (IU), which are related to the WHO standard for factor VIII products.
Število enot faktorja VIII izražamo v internacionalnih enotah (i.e., IU - International Units), ki se nanašajo na standard SZO za pripravke faktorja VIII.
When infused into a haemophilia patient, octocog alfa binds to endogenous von Willebrand Factor in the patient's circulation.
Po injiciranju bolniku s hemofilijo se oktokog alfa veže na endogeni von Willebrandov faktor v bolnikovem krvnem obtoku.
What ADVATE looks like and contents of the pack ADVATE is a white to off-white friable powder.
Izgled zdravila ADVATE in vsebina pakiranja Zdravilo ADVATE je bel do belkast drobljiv prašek.
Very common side effects (may affect more than 1 in 10 people) Factor VIII inhibitors (for children not previously treated with Factor VIII medicines).
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) Zaviralci faktorja VIII (pri otrocih, ki se predhodno še niso zdravili z zdravili s faktorjem VIII).
Adults (n=109)
Odrasli (n = 109)
• Inspect the prepared solution for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from foreign particles).
• Pripravljeno raztopino morate pred uporabo skrbno pregledati, ali vsebuje delce in ali je obarvana (raztopina mora biti bistra in brezbarvna in ne sme vsebovati tujih delcev).
The European Medicines Agency has waived the obligation to submit the results of studies with ADVATE in all subsets of the paediatric population in haemophilia A (congenital factor VIII deficiency) in "Immune Tolerance Induction (ITI) in patients with haemophilia A (congenital factor VIII deficiency) who have developed inhibitors to factor VIII" and "treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)".
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom ADVATE za vse podskupine pediatrične populacije s hemofilijo A (dednim pomanjkanjem faktorja VIII) pri »indukciji imunske tolerance (ITI) pri bolnikih s hemofilijo A (dednim pomanjkanjem faktorja VIII), pri katerih so se pojavili zaviralci faktorja VIII,« in »zdravljenju in preventivi krvavitve pri bolnikih s hemofilijo A (dednim pomanjkanjem faktorja VIII)« (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The ADRs that occurred in the highest frequency were development of neutralising antibodies to factor VIII (inhibitors), headache and fever.
Neželeni učinki, ki so se pojavilinajpogosteje, so bili: nastanek nevtralizirajočih protiteles proti faktorju VIII (zaviralcev), glavobol ter zvišana telesna temperatura
Related to surgery catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative bruise.
S katetrom povezane okužbe, zmanjšano število rdečih krvničk, otekanje okončin in sklepov, podaljšano krvavenje po odstranitvi drena, znižana koncentracija faktorja VIII in pooperativna podplutba.
The usual dose of octocog alfa is 20 to 40 IU per kg body weight, administered every 2 to 3 days.
Običajni odmerek oktokoga alfa je med 20 in 40 i.e. na kg telesne mase, na vsake 2 do 3 dni.
Octocog alfa is a glycoprotein consisting of 2332 amino acids with an approximate molecular mass of 280 kD.
Oktokog alfa je glikoprotein sestavljen iz 2.332 aminokislin s približno molekulsko maso 280 kD.
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII.
Farmakoterapevtska skupina: antihemoragiki: koagulacijski faktor VIII.
Instructions for preparation and administration
Navodila za pripravo in uporabo
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discoloration.
Preveriti morate videz rekonstituirane raztopine glede morebitne prisotnosti tujih delcev in/ali obarvanosti.
A total of 195 subjects with severe haemophilia A (baseline factor VIII < 1%) provided PK parameters that were included in the Per-Protocol PK analysis set.
Na podlagi skupno 195 preiskovancev s hudo obliko hemofilije A (osnovna vrednost faktorja VIII < 1 %) so bili oblikovani farmakokinetični parametri, vključeni v nabor farmakokinetičnih analiz po protokolu.
Misapplication (injection into the artery or outside the vein) should be avoided as mild, short term injection site reactions, such as bruising and redness, may occur.
Napačno uporabo (injiciranje v arterijo ali poleg vene) je treba preprečiti, ker povzroči blage, kratkotrajne reakcije na mestu injiciranja, kot sta podplutba in pordelost.
Name and address of the manufacturers responsible for batch release
Imena in naslovi izdelovalcev, odgovornih za sproščanje serij
The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Jakost zdravila (v mednarodnih enotah) je določena s pomočjo kromogenega testa po evropski farmakopeji.
In this case, this medicine expires at the end of this 6 month period or the expiration date printed on the product vial, whichever is earlier.
V tem primeru se rok uporabe zdravila izteče na koncu tega šestmesečnega obdobja ali po preteku roka uporabnosti, natisnjenega na viali zdravila, kar se zgodi prej.
Do not remove the blue cap until instructed in a later step.
Modrega pokrovčka ne smete sneti do koraka z navodilom za odstranitev.
Uncommon (PTPs)d Very common (PUPs)
občasni (PZB)d zelo pogosti (PNB)d