FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
Slovenian: V tej študiji so za preprečitev tromboflebitisa na mestu infundiranja tako kot pri drugih dolgotrajnih intravenskih infuzijah uporabili heparin.
English: 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.
Slovenian: Število danih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard SZO za zdravila s faktorjem VIII.
English: The MAHs provided an analysis of low and high titre inhibitor development in PUPs with severe haemophilia A (FVIII < 1%) from all clinical trials and observational studies conducted with their products, along with critical discussion on the limitations of these studies.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predložili analizo pojava nizkih in visokih titrov zaviralcev pri predhodno nezdravljenih bolnikih s hudo hemofilijo A (FVIII < 1 %) iz vseh kliničnih preskušanj in opazovalnih študij, opravljenih z njihovimi zdravili, skupaj s kritično razpravo o omejitvah omenjenih študij.
English: If a further dose is required, remove the empty syringe by turning it anti-clockwise.
Slovenian: Če je potreben dodaten odmerek zdravila, odstranite prazno injekcijsko brizgo tako, da jo obrnete v nasprotni smeri urnega kazalca.
English: Follow the directions given by your doctor closely and use the detailed instructions for reconstitution and administration provided at the end of this leaflet.
Slovenian: Natančno upoštevajte navodila zdravnika in podrobnejša navodila za rekonstitucijo in uporabo zdravila, ki so na koncu tega navodila.
English: 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).
Slovenian: 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).
English: • your bleeding is not being controlled with your usual dose of this medicine.
Slovenian: • se krvavitev po uporabi za vas predpisanega običajnega odmerka tega zdravila ne ustavi.
English: If you have any questions about KOGENATE Bayer and compatible separate filters contact Bayer AG.
Slovenian: Če imate kakršna koli vprašanja o zdravilu KOGENATE Bayer in z njim združljivih ločenih filtrih, se obrnite na podjetje Bayer AG.
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Slovenian: Raztopino injicirajte v veno 2 do 5 minut; pri tem bodite ves čas pozorni na položaj igle.
English: Treatment with both pdFVIII and rFVIII can lead to development of inhibitors (tested with the Nijmegen method of the Bethesda assay and defined as ≥0.6 Bethesda units (BU) for “a low titre” inhibitor and >5 BU for a “high-titre” inhibitor).
Slovenian: Zdravljenje s pdFVIII in rFVIII lahko privede do pojava zaviralcev (ki se dokažejo z Nijmegenovo metodo v testu Bethesda in so opredeljeni kot ≥ 0,6 Bethesda enot (BU) pri „nizkem titru“ in > 5 BU pri „visokem titru“ zaviralcev).
English: Then, strongly press down the fingerplate near the syringe tip using your thumb and index finger (C) until the finger plate meets the top edge of the reconstitution cap (Bio-Set).
Slovenian: Potem s palcem in kazalcem (C) ploščico za prste blizu vrha injekcijske brizge močno potisnite navzdol, dokler se ploščica za prste ne dotakne vrhnjega roba nastavka za rekonstitucijo (Bio-Set).
English: • two alcohol swabs for single use
Slovenian: • 2 alkoholna tampona za enkratno uporabo
English: Rare (may affect up to 1 in 1,000 users):
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
Slovenian: Vialo in napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: It is uncertain whether the findings of SIPPET can be extrapolated to the risk of inhibitors in PUPs in current clinical practice in the EU as treatment modality and intensity have been suggested as risk factors for inhibitor development in previous studies.
Slovenian: Ni znano, ali se ugotovitve študije SIPPET lahko ekstrapolirajo na tveganje za pojav zaviralcev pri predhodno nezdravljenih bolnikih v sedanji klinični praksi v EU, saj sta bila v preteklih študijah kot dejavnik tveganja za pojav zaviralcev predlagana način in intenzivnost zdravljenja.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Slovenian: Če je potreben centralni venski kanal (CVK), je treba upoštevati tveganje za s CVK povezanimi zapleti kot so lokalne okužbe, bakteriemija in tromboza na mestu katetrizacije.
English: Each package of KOGENATE Bayer contains:
Slovenian: Eno pakiranje zdravila KOGENATE Bayer vsebuje:
English: Therefore, there is a high degree of uncertainty around extrapolating the SIPPET findings to the entire rFVIII class, particularly for more recentlyauthorised rFVIII products which were not included in the SIPPET trial.
Slovenian: Zato obstaja velika negotovost glede ekstrapolacije ugotovitev študije SIPPET na celoten razred rFVIII, zlasti za nedavno odobrena zdravila z rFVIII, ki niso bila vključena v preskušanje SIPPET;
English: This preparation does not contain von Willebrand factor and is therefore not to be used in von Willebrand's disease.
Slovenian: Zdravilo ne vsebuje von Willebrandovega faktorja, zato se ne sme uporabljati za zdravljenje von Willebrandove bolezni.
English: If you have used more KOGENATE Bayer than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer, kot bi smeli, o tem obvestite zdravnika.
English: These compatible filters are luer adaptor-type of Polyacrylic housing with integrated filter element of a Polyamide screen of 5 - 20 micrometer mesh size.
Slovenian: Filtri, ki so združljivi z luer adapterjem, so iz poliakrilnega ohišja z vgrajenim filtrom iz poliamidne mreže z velikostjo luknjic 5 - 20 mikrometrov.
English: Each vial contains nominally 250/500/1000/2000/3000 IU human coagulation factor VIII (INN: octocog alfa).
Slovenian: Ena viala vsebuje nominalno 250/500/1000/2000/3000 i.e. humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
English: However, in some cases, especially for younger patients, shorter dose intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, zlasti pri mlajših bolnikih, pa bodo morda potrebni krajši presledki med odmerki ali pa večji odmerki.
English: • vial adapter
Slovenian: • adapter za vialo
English: After administration of KOGENATE Bayer, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Slovenian: Po uporabi zdravila KOGENATE Bayer se maksimalna aktivnost faktorja VIII zmanjšuje dvofazno eksponentno, razpolovni čas je približno 15 ur.
English: Overall, the PRAC maintains its conclusions that standardised information on the frequency for FVIII products in PUP and PTP should be reflected in section 4.8 of the SmPC, unless another frequency range for a specific medicinal product is demonstrated by robust clinical studies for which the results would be summarised in section 5.1.
Slovenian: Na splošno je odbor PRAC ohranil svoje mnenje, da se morajo standardizirane informacije o pogostnosti za zdravila s FVIII pri predhodno nezdravljenih in pri predhodno zdravljenih bolnikih odražati v poglavju 4.8 povzetka glavnih značilnosti zdravila, razen če se za specifično zdravilo ne dokaže drugo območje pogostnosti z robustnimi kliničnimi študijami, katerih rezultati so povzeti v poglavju 5.1.
English: This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Slovenian: Pripravek ne vsebuje von Willebrandovega faktorja, zato ni indiciran za zdravljenje von Willebrandove bolezni.
English: 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.
Slovenian: 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.
English: In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, še posebej pri mlajših bolnikih, bodo morda potrebni krajši presledki med odmerki ali pa večji odmerki.
English: KOGENATE Bayer should be reconstituted and administered with the components provided with each package.
Slovenian: Zdravilo KOGENATE Bayer se lahko rekonstituira in uporablja le s sestavnimi deli, priloženimi v vsakem pakiranju.
English: Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.
Slovenian: Humani koagulacijski faktor VIII je izdelan z rekombinantno DNA tehnologijo (rDNA) v ledvičnih celicah mladičev hrčkov, ki vsebujejo gen za humani faktor VIII.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Slovenian: Za navodila glede rekonstitucije zdravila pred uporabo, glejte poglavje 6.6 in navodilo za uporabo.
English: Cardiovascular events
Slovenian: Srčnožilni dogodki
English: In particular the skin related reactions may occur commonly, whereas a progress to severe anaphylaxis (including shock) is considered to be rare.
Slovenian: Pogosto se pojavijo kožne reakcije, medtem ko se poslabšanje do pojava hude anafilakse (vključno s šokom) pojavi redko.
English: The cumulative incidence of all inhibitors was 26.8% (95% confidence interval [CI], 18.4 to 35.2) with pdFVIII and 44.5% (95% CI, 34.7 to 54.3) with rFVIII; the cumulative incidence of high-titre inhibitors was 18.6% (95% CI, 11.2 to 26.0) and 28.4% (95% CI, 19.6 to 37.2), respectively.
Slovenian: Kumulativna pojavnost vseh titrov zaviralcev je bila 26,8 % (95-odstotni interval zaupanja [IZ] od 18,4 do 35,2) pri pdFVIII in 44,5 % (95-odstotni IZ od 34,7 do 54,3) pri rFVIII; kumulativna pojavnost visokega titra zaviralcev je bila 18,6 % (95-odstotni IZ od 11,2 do 26,0) pri pdFVIII in 28,4 % (95% IZ, 19,6 na 37,2) pri rFVIII.
English: The active substance is human coagulation factor VIII (octocog alfa) produced by recombinant DNA technology.
Slovenian: Zdravilna učinkovina je humani koagulacijski faktor VIII (oktokog alfa) izdelan z rekombinantno DNA tehnologijo.
English: Holding the vial adapter in place, remove the syringe from the vial adapter (the latter should remain attached to the vial).
Slovenian: Adapter za vialo držite na mestu in odstranite injekcijsko brizgo z adapterja za vialo (ta naj ostane pritrjen na vialo).
English: The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A (plasma FVIII concentration<1%) with either the use of pdFVIII or rFVIII concentrates.
Slovenian: Študija SIPPET je bila neslepo, randomizirano, multicentrično, večnacionalno preskušanje, v kateri so preučili pojavnost nevtralizirajočih aloprotiteles pri bolnikih s hudo prirojeno hemofilijo A (plazemska koncentracija FVIII < 1 %) s koncentrati pdFVIII ali rFVIII.
English: 2 plasters
Slovenian: 2 obliža
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Slovenian: Predvsem pri večjih kirurških posegih je nujno natančno spremljanje poteka nadomestnega zdravljenja z analizo strjevanja krvi (aktivnost faktorja VIII v plazmi).
English: Each vial of KOGENATE Bayer contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Slovenian: Ena viala zdravila KOGENATE Bayer vsebuje nominalno 250, 500, 1000, 2000 ali 3000 i.e. oktokoga alfa.
English: For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir.
Slovenian: Za kontinuirano infuzijo so klinično in in vitro stabilnost prikazali z uporabo premičnih črpalk s PVC zbiralnikom.
English: If this occurs, stop administering the product immediately and seek medical advice.
Slovenian: V tem primeru takoj prenehajte uporabljati zdravilo in poiščite medicinsko pomoč.
English: Warm both an unopened vial and a syringe in your hands to a comfortable temperature (do not exceed 37 °C).
Slovenian: Z rokami ogrejte neodprto vialo in injekcijsko brizgo na primerno temperaturo (ne več kot 37°C).
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Slovenian: Preglednica 1: Smernice za odmerjanje pri krvavitvah in kirurških posegih Stopnja krvavitve/ vrsta kirurškega posega
English: Therefore, the PRAC concluded that the benefit-risk balance of the human plasma derived and recombinant coagulation Factor VIII containing medicinal products remains favourable and recommended the variations to the terms of the marketing authorisations.
Slovenian: Zato je odbor PRAC ugotovil, da je razmerje med koristmi in tveganjem za zdravila, ki vsebujejo faktor VIII, pridobljen iz plazme ali rekombinantno, še vedno ugodno in priporoča spremembe pogojev dovoljenj za promet.
English: Your doctor may carry out tests to ensure that your current dose of this medicine provides adequate factor VIII levels.
Slovenian: Zdravnik bo morda želel opraviti preiskave, da preveri ali predpisani odmerek tega zdravila zagotavlja ustrezno raven faktorja VIII.
English: Individual studies have identified a wide range of inhibitor frequency in PUPs across products, and the SIPPET study was not designed to differentiate between individual products in each class.
Slovenian: V posameznih študijah so odkrili širok razpon pojavnosti zaviralcev pri predhodno nezdravljenih bolnikih med zdravili, študija SIPPET pa ni bila zasnovana, da bi razlikovala med zdravili znotraj posameznega razreda.
English: 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).
Slovenian: 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 (razpon 1,6 - 4,6 ml/h/kg).
English: The speed of administration should be based on your comfort, but should not be faster than 2 mL per minute.
Slovenian: Hitrost injiciranja naj bo prilagojena vašemu počutju, vendar ne injicirajte hitreje kot 2 ml na minuto.
English: The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case.
Slovenian: Velikost odmerka in pogostnost odmerjanja naj bosta določena glede na klinično učinkovitost pri posameznem bolniku.
English: • 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)
Slovenian: • preobčutljivostne reakcije, tudi hude nenadne alergijske reakcije (ki lahko vključujejo izpuščaj, navzeo, koprivnico, angioedem, mrzlico, pordelost, glavobol, letargijo, zasoplost ali težave pri dihanju, nemir, tahikardijo, ščemenje ali anafilaktični šok, npr. tiščanje v prsnem košu/splošno slabo počutje, omotica in občutek siljenja na bruhanje in blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, ko vstanete)
English: KOGENATE Bayer can be infused by continuous infusion.
Slovenian: Zdravilo KOGENATE Bayer se lahko uporabi kot kontinuirana infuzija.
English: This is similar to that of plasmaderived factor VIII which has a mean terminal half-life of approx. 13 hours.
Slovenian: To je podobno kot pri faktorju VIII, pridobljenem iz plazme, kjer je povprečni razpolovni čas približno 13 ur.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
English: No case of overdose with recombinant coagulation factor VIII has been reported.
Slovenian: Ni poročil o prevelikem odmerjanju rekombinantnega koagulacijskega faktorja VIII.
English: The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 mL/min).
Slovenian: Hitrost injiciranja naj bo prilagojena bolnikovemu počutju (največja dovoljena hitrost injiciranja: 2 ml/min).
English: You may be at 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.
Slovenian: Obstaja lahko tveganje za zaplete, povezane s CVK, kot so lokalne okužbe, prisotnost bakterij v krvi (bakteriemija) in nastanek krvnih strdkov v krvnih žilah (tromboza) na mestu vstavitve katetra.
English: Gently rotate the vial until all powder is dissolved.
Slovenian: Previdno obračajte vialo, dokler se ves prašek ne raztopi.
English: Furthermore, the PRAC examined clinical trials and the scientific literature for de novo inhibitors in PTPs.
Slovenian: Poleg tega je odbor PRAC pregledal klinična preskušanja in strokovno literaturo glede zaviralcev de novo pri predhodno zdravljenih bolnikih.
English: In 2013, PRAC had concluded that the RODIN/Pednet findings were not sufficiently robust to support a conclusion that Kogenate FS/Helixate NexGen was associated with an increased risk of developing factor VIII inhibitors compared with other products.
Slovenian: Leta 2013 je odbor PRAC ugotovil, da ugotovitve študije RODIN/Pednet niso bile dovolj robustne, da bi podprle sklep, da sta zdravili Kogenate FS/Helixate NexGen povezani z večjim tveganjem za pojav zaviralcev faktorja VIII v primerjavi z drugimi zdravili.
English: After reconstitution, the product must be used within 3 hours.
Slovenian: Po rekonstituciji je treba zdravilo uporabiti v 3 urah.
English: • Inhibitor development is an identified risk with both pdFVIII and rFVIII products.
Slovenian: • pojav zaviralcev je dokazano tveganje pri zdravilih s pdFVIII in rFVIII.
English: • you require a central venous access device (CVAD) for the administration of KOGENATE Bayer.
Slovenian: • je pri vas za vnos zdravila KOGENATE Bayer potreben centralni venski kateter (CVK).
English: In 2016, PRAC had considered the findings of meta-analysis of all three studies (RODIN/Pednet, UKHCDO and FranceCoag studies), and again concluded that the currently available evidence does not confirm that Kogenate Bayer/Helixate NexGen is associated with an increased risk of factor VIII inhibitors, compared with other recombinant factor VIII products in PUPs.
Slovenian: Leta 2016 je odbor PRAC upošteval ugotovitve metaanalize vseh treh študij (študije RODIN/Pednet, UKHCDO in FranceCoag) in ponovno ugotovil, da trenutno razpoložljivi dokazi ne potrjujejo, da je zdravilo Kogenate Bayer/Helixate NexGen povezano z večjim tveganjem za pojav zaviralcev faktorja VIII v primerjavi z drugimi zdravili z rekombinantnim faktorjem VIII pri predhodno nezdravljenih bolnikih.
English: The doctor should always adjust the dose and the frequency of administration according to your individual needs.
Slovenian: Zdravnik mora odmerek in pogostost dajanja odmerka tega zdravila prilagoditi glede na vaše individualne potrebe.
English: 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.
Slovenian: Zdravilo KOGENATE Bayer kot pomožno snov vsebuje majhno količino polisorbata 80, za katerega je znano, da poveča hitrost ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materialov.
English: 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.
Slovenian: Če je raven zaviralca manjša kot 10 Bethesda enot (BE) na mililiter, ga je možno nevtralizirati z dodatnim rekombinantnim koagulacijskim faktorjem VIII in nadaljevati klinično učinkovito zdravljenje z zdravilom KOGENATE Bayer.
English: • The section 4.4 of the SmPC should be amended to include a warning on the clinical importance of monitoring patients for FVIII inhibitor development (in particular warning on the clinical consequences of low compared to high titre inhibitors).
Slovenian: • poglavje 4.4 povzetka glavnih značilnosti zdravila je treba spremeniti tako, da se vključi opozorilo o kliničnem pomenu spremljanja bolnikov za pojav zaviralcev FVIII (zlasti opozorilo o različnih kliničnih posledicah nizkega in visokega titra zaviralcev);
English: What you need to know before you use KOGENATE Bayer
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer
English: In view of the above, the PRAC recommended the following updates of sections 4.4, 4.8 and 5.1 of the SmPC as well as sections 2 and 4 of the Package Leaflet for the FVIII products indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) as follows:
Slovenian: Glede na navedeno je odbor PRAC priporočil naslednje spremembe poglavij 4.4, 4.8 in 5.1 povzetka glavnih značilnosti zdravila ter poglavij 2 in 4 navodila za uporabo za zdravila s FVIII, ki so indicirana za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII), kot sledi:
English: 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.
Slovenian: Povečanje ravni faktorja VIII po uporabi, zlasti pri tistih s prisotnimi srčnožilnimi dejavniki tveganja, predstavlja pri bolniku najmanj enako tveganje za zaporo žil ali miokardni infarkt kakor pri populaciji, ki nima hemofilije.
English: In this case, this medicine expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier.
Slovenian: V tem primeru rok uporabnosti zdravila poteče ob koncu 12-mesečnega obdobja ali z datumom izteka roka uporabnosti navedenega na viali zdravila, odvisno kateri je prej.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - FOR BIO-SET SYSTEM
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - ZA SISTEM BIO-SET
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERRESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike je treba poučiti o zgodnjih znakih preobčutljivosti, ki vključujejo koprivnico, navzeo, generalizirano urtikarijo, tiščanje v prsnem košu, zasoplost, hipotenzijo in anafilakso.