FrancophonIA/ELRC3.0 huggingface dataset:
English: b) By continuous infusion Raise factor VIII activity presurgery 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.
Slovenian: b) s kontinuirano infuzijo Pred kirurškim posegom je treba zvečati aktivnost faktorja VIII z začetno bolusno infuzijo ter takoj nadaljevati s kontinuirano infuzijo (i.e./kg/h), ki je prilagojena glede na bolnikov dnevni očistek in želene vrednosti faktorja VIII (vsaj 7 dni).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERRESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
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: Infusion rate (in IU/kg/h) = Clearance (in ml/h/kg) × desired factor VIII level (in IU/ml)
Slovenian: Hitrost infundiranja (v i.e./kg/h) = očistek (v ml/h/kg) × želena koncentracija faktorja VIII (v i.e./ml)
English: Experience regarding fertility or the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Slovenian: Izkušenj o plodnosti ali uporabi zdravila Helixate NexGen med nosečnostjo in dojenjem ni.
English: • You must filter the reconstituted product before administration to remove potential particulate matter in the solution.
Slovenian: • Rekonstituirano zdravilo morate pred uporabo filtrirati, da odstranite morebitne delce v raztopini.
English: Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor VIII, oznaka ATC: B02BD02 Mehanizem delovanja
English: • Your doctor may carry out tests to ensure that your current dose of this medicine provides adequate factor VIII levels.
Slovenian: • Vaš zdravnik bo morda želel opraviti preiskave, da ugotovi ali predpisani odmerek tega zdravila pri vas zadostuje za zagotavljanje želene aktivnosti faktorja VIII.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Slovenian: Izračun potrebnega odmerka faktorja VIII temelji na empirični ugotovitvi, da ena mednarodna enota (i.e.) faktorja VIII na kilogram telesne mase, zveča aktivnost plazemskega faktorja VIII za 1,5 - 2,5 % glede na normalno aktivnost.
English: • chest tightness/general feeling of being unwell
Slovenian: • tiščanje v prsih/splošno slabo počutje
English: Follow the directions given by your doctor closely and use the instructions below as a guide:
Slovenian: Pri uporabi zdravila natančno upoštevajte navodila vašega zdravnika in naslednje navodilo za pripravo in uporabo:
English: Solvent Water for injections, sterilised.
Slovenian: Vehikel voda za injekcije, sterilna
English: Very common: may affect more than 1 in 10 users
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Slovenian: Zato se po kakršni koli zamenjavi zdravila priporoča skrbno spremljanje vseh bolnikov glede nastanka inhibitorjev.
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 uporablja za zdravljenje von Willebrandove bolezni.
English: Helixate NexGen is used for treatment and prophylaxis of bleeding adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Slovenian: Zdravilo Helixate NexGen se uporablja za zdravljenje in preprečevanje krvavitev pri odraslih, mladostnikih in otrocih vseh starosti s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
Slovenian: Medtem ko držite bat brizge pritisnjen, obrnite sistem na glavo in počasi vlecite bat brizge, da se brizga napolni z raztopino.
English: Antibodies (Inhibitors)
Slovenian: Protitelesa (inhibitorji)
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Slovenian: Pri vseh bolnikih, ki se zdravijo z zdravili, ki vsebujejo koagulacijski faktor VIII, je treba z ustreznim kliničnim opazovanjem in z laboratorijskimi preiskavami skrbno spremljati, ali je prišlo do nastanka inhibitorjev.
English: If this occurs, stop administering the product immediately and seek medical advice.
Slovenian: V tem primeru takoj prenehajte uporabljati zdravilo in poiščite zdravniško pomoč.
English: Helixate NexGen should be reconstituted and administered with the components provided with each package.
Slovenian: Zdravilo Helixate NexGen se lahko rekonstituira in uporablja le s sestavnimi deli, priloženimi v vsakem pakiranju.
English: 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 sections 4.3 and 4.4).
Slovenian: Kljub temu pa pri nekaterih bolnikih, ki so nagnjeni k alergijam obstaja možnost alergijskih reakcij na sestavine zdravila, npr. na sledove beljakovin miši in hrčkov (glejte poglavji 4.3 in 4.4).
English: 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.
Slovenian: Ob prisotnosti inhibitorja je treba odmerek zdravila prilagajati glede na klinični odgovor in spremljati aktivnost faktorja VIII v plazmi.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Slovenian: 12 - 24 ur, 3 - 4 dni ali več, dokler ne izgine bolečina in se stanje ne izboljša.
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 exposure days.
Slovenian: 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.
English: It is recommended that every time that you use Helixate NexGen, the name and batch number of the product are documented.
Slovenian: Priporoča se, da vsakič po uporabi zdravila Helixate NexGen zabeležite ime in številko serije zdravila.
English: 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.
Slovenian: 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.
English: Filtering is achieved by using the Mix2Vial adapter.
Slovenian: Pri filtriranju je treba uporabiti adapter Mix2vial.
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 Helixate NexGen.
Slovenian: 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.
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, morajo biti presledki med odmerki krajši ali pa odmerki večji.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
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
English: Determine the point of injection and prepare antiseptically.
Slovenian: Določite mesto injiciranja in ga dezinficirajte.
English: 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.
Slovenian: Po dajanju zdravila Helixate NexGen se maksimalna aktivnost faktorja VIII zmanjšuje dvofazno eksponentno, razpolovni čas je približno 15 ur.
English: Marketing Authorisation Holder Bayer Pharma AG 13342 Berlin Germany
Slovenian: Imetnik dovoljenja za promet Bayer Pharma AG 13342 Berlin
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Slovenian: Brizgo držite pokončno in potiskajte bat toliko časa, da v brizgi ne bo več zraka.
English: • dysgeusia
Slovenian: • disgevzija
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Concentrations of rFVIII solution 100 IU/ml 200 IU/ml 400 IU/ml
Slovenian: 3 ml/h/kg koncentracije raztopin rFVIII 100 i.e./ml 200 i.e./ml 400 i.e./ml
English: Inhibitor development in previously untreated and treated patients (PUPs / PTPs) has been reported (see section 4.4).
Slovenian: previously untreated patient / PTP - previously treated patient) (glejte poglavje 4.4).
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5
Slovenian: Potrebni odmerek (i.e.) = telesna masa (kg) × želeni dvig aktivnosti faktorja VIII (% normalne vrednosti) × 0,5
English: Patients should be monitored for the development of factor VIII inhibitors.
Slovenian: Pri bolnikih je treba spremljati ali je prišlo do nastanka inhibitorjev faktorja VIII.
English: Blood and the Lymphatic System Disorders
Slovenian: Bolezni krvi in limfatičnega sistema nastanek inhibitorjev proti FVIII
English: • formation of neutralising antibodies to factor VIII (inhibitors) in previously untreated patients
Slovenian: • nastanek nevtralizirajočih protiteles proti faktorju VIII (inhibitorjev) pri predhodno nezdravljenih bolnikih
English: One patient was lost to follow up and one patient developed a low-titre inhibitor during post study follow-up.
Slovenian: Enega bolnika niso spremljali, pri enem pa so je med spremljanjem po študiji ugotovili nastanek nizkega titra inhibitorjev.
English: Use only the medical devices for reconstitution and administration that are provided with each package of this medicine.
Slovenian: Za rekonstitucijo in injiciranje tega zdravila lahko uporabite samo pribor, ki je priložen v vsakem pakiranju zdravila.
English: 16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
Slovenian: Pustite, da kri teče nazaj k odprtemu koncu pribora za punkcijo vene in nato pritrdite brizgo z raztopino.
English: Data show that Helixate NexGen has been used to induce immune tolerance.
Slovenian: Podatki kažejo, da se zdravilo Helixate NexGen uporablja za indukcijo imunske tolerance.
English: If you are unsure about this, ask your doctor.
Slovenian: Če glede navedenega niste prepričani, se posvetujte s svojim zdravnikom.
English: Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • formation of neutralising antibodies to factor VIII (inhibitors) in previously treated patients
Slovenian: • nastanek nevtralizirajočih protiteles proti faktorju VIII (inhibitorjev) pri predhodno zdravljenih bolnikih
English: • 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.
Slovenian: • 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).
English: 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).
Slovenian: 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.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Slovenian: Potek zdravljenja teh bolnikov mora voditi zdravnik z izkušnjami v zdravljenju hemofilije in uporabe inhibitorjev faktorja VIII.
English: May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label.
Slovenian: Zdravilo lahko do 12 mesecev shranjujete pri temperaturi do 25 °C do navedenega datuma izteka roka uporabnosti.
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Slovenian: Vzemite Mix2Vial skupaj s pretisnim omotom in potisnite konico modrega adapterja naravnost navzdol skozi zamašek viale z vehiklom.
English: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
Slovenian: • 1 vialo s praškom (10 ml viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
English: Helixate NexGen can be infused by continuous infusion.
Slovenian: Helixate NexGen se lahko uporabi kot kontinuirana infuzija.
English: • one vial with solvent (6 ml clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
Slovenian: • 1 vialo z vehiklom (6 ml viala iz prozornega stekla tipa 1 s sivim klorobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Slovenian: Postavite vialo z vehiklom na ravno, čisto površino in jo trdno primite.
English: 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).
Slovenian: 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.
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: Količine faktorja VIII, potrebne za zdravljenje, so izražene v mednarodnih enotah (i.e.), ki so določene s standardom SZO za faktor VIII.
English: • 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.
Slovenian: • 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.
English: The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Slovenian: Kompleks faktorja VIII in von Willebrandovega faktorja (vWF) je sestavljen iz dveh molekul
English: Systemic Hypersensitivit y reactions (including anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)
Slovenian: sistemske preobčutljivostn e reakcije (tudi anafilaksija, navzea, nenormalen krvni tlak in omotica)
English: 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).
Slovenian: (glede na normalno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
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: 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
English: For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).
Slovenian: Za izračun hitrosti infundiranja v ml/h se hitrost infundiranja i.e./h/kg pomnoži s kg telesne mase/koncentracija raztopine (i.e./ml).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Sedaj ko je raztopina v brizgi, trdno primite brizgo (bat brizge naj gleda navzdol) in odstranite prozoren Mix2Vial adapter z brizge.
English: After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied).
Slovenian: Po rekonstituciji raztopino filtrirajte skozi pribor za prenos vehikla Mix2Vial s filtrom v sterilno brizgo (igla in brizga sta priloženi).
English: After reconstitution, the product must be used within 3 hours.
Slovenian: Zdravilo je treba po rekonstituciji uporabiti v 3 urah.
English: He/she should always adjust the amount of this medicine to be administered 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: 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.
Slovenian: S tem se začasno popravi pomanjkanje faktorja VIII in se zmanjša nagnjenost h krvavitvam.
English: The degree and duration of aPTT normalisation observed after administration of Helixate NexGen is similar to that achieved with plasma-derived factor VIII.
Slovenian: Stopnja in trajanje normalizacije APTČ sta pri zdravilu Helixate NexGen podobna kot pri faktorju
English: • local reactions where you injected the medication (e.g. burning sensation, temporary redness)
Slovenian: • lokalne reakcije na mestu injiciranja (npr. pekoča bolečina, prehodna rdečica)
English: Therefore, Helixate NexGen should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Izkušenj o uporabi zdravila Helixate NexGen med nosečnostjo in dojenjem ni, zato ga med nosečnostjo in dojenjem uporabljamo le, če je to jasno indicirano.
English: 1 vial with 5.0 ml water for injections.
Slovenian: OVOJNINAH VIALA S 5,0 ML VODE ZA INJEKCIJE
English: Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)
Slovenian: Bolezni imunskega sistema preobčutljivos tne kožne reakcije (pruritus, urtikatija in osip)