FrancophonIA/ELRC3.0 huggingface dataset:
English: You and your guardian will be trained to detect early signs of side effects, especially allergic reactions.
Slovenian: Vi in vaš skrbnik se bosta usposobila za prepoznavanje zgodnjih znakov neželenih učinkov, zlati alergijskih reakcij.
English: The maximum IgA content is 140 micrograms/ml.
Slovenian: Največja vsebnost IgA je 140 mikrogramov/ml.
English: In all other cases you should be monitored during the infusion and for at least 20 minutes after you receive HyQvia for the first few infusions.
Slovenian: V vseh drugih primerih vas bodo spremljali med infuzijo in vsaj 20 minut po prvih nekaj infuzijah zdravila HyQvia.
English: Interference with serological testing
Slovenian: Motnje seroloških preiskav
English: Aseptic meningitis syndrome has been reported to occur in association with intravenous and subcutaneous immunoglobulin treatment; the symptoms usually begin within several hours to 2 days following immunoglobulin treatment.
Slovenian: Poročali so o pojavu sindroma aseptičnega meningitisa v povezavi z intravenskim in subkutanim imunoglobulinskim zdravljenjem; ti simptomi se po navadi začnejo v nekaj urah do 2 dneh po imunoglobulinskem zdravljenju.
English: OUTER CARTON (2.5 G, 5 G, 10 G, 20 G AND 30 G)
Slovenian: ZUNANJA ŠKATLA (2,5 G; 5 G; 10 G; 20 G IN 30 G)
English: The dose of HyQvia was based on the previous treatment with intravenous IG 10% (320 to 1,000 mg/kg body weight /4 weeks) and was individually adapted, ensuring adequate IgG levels throughout the study.
Slovenian: Odmerek zdravila HyQvia je temeljil na predhodnem zdravljenju z intravenskim IG 10 % (od 320 do 1.000 mg/kg telesne mase/4 tedne) in je bil prilagojen posamezniku, tako da so bile zagotovljene zadostne ravni IgG skozi celo študijo.
English: Wings of needle should lay flat on the skin.
Slovenian: Metuljček igle mora plosko ležati na koži.
English: Recombinant human hyaluronidase is a soluble recombinant form of human hyaluronidase that increases the permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan.
Slovenian: Rekombinantna humana hialuronidaza je topna rekombinantna oblika humane hialuronidaze, ki poveča permeabilnost subkutanega tkiva, tako da začasno depolimerizira hialuronan.
English: See image for infusion site locations.
Slovenian: Glejte sliko položajev mest infundiranja.
English: Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected.
Slovenian: Klinične izkušnje z imunoglobulini kažejo, da ni pričakovati škodljivih učinkov IG 10 % na plodnost.
English: Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm
Slovenian: Preiskave likvorja so pogosto pozitivne s pleocitozo, ki doseže nekaj tisoč celic na mm
English: • Cap: Protective cap is on the dual vial unit.
Slovenian: • Zaporka: Zaščitna zaporka je na enoti z dvema vialama.
English: No skin changes were observed that did not resolve during the clinical study.
Slovenian: Niso odkrili kožnih sprememb, ki niso izzvenele med klinično študijo.
English: Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be treated with HyQvia only under close medical supervision.
Slovenian: Bolniki s protitelesi proti IgA, pri katerih je zdravljenje s subkutanimi zdravili z IgG edina možnost, morate z zdravilom HyQvia zdraviti pod skrbnim zdravniškim nadzorom.
English: The most frequently reported adverse reactions (ARs) of HyQvia were local reactions.
Slovenian: Neželeni učinki zdravila HyQvia, o katerih so poročali najpogosteje, so bile lokalne reakcije.
English: Patients should be sufficiently hydrated before use of immunoglobulins.
Slovenian: Pred uporabo imunoglobulinov morajo biti bolniki zadostno hidrirani.
English: 35.7 (32.4 to 40.4)
Slovenian: 35,7 (32,4 do 40,4)
English: • Avoid bony areas, visible blood vessels, scars and any areas of inflammation or infection.
Slovenian: • Izognite se koščenim področjem, vidnim žilam, brazgotinam in vsem vnetim ali okuženim področjem.
English: Studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction in animals are impracticable due to induction of and interference by developing antibodies to heterologous proteins.
Slovenian: Študije toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja niso izvedljive zaradi indukcije razvoja protiteles proti heterolognim beljakovinam in njihove interference.
English: If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable.
Slovenian: Če bolnik izpusti odmerek, mu izpuščeni odmerek aplicirajte čim prej, nato pa nadaljujte z načrtovanim razporedom zdravljenja.
English: The pharmacokinetic results are presented in the table below, as compared to data for intravenous administration of IG 10% obtained in the same study.
Slovenian: Rezultati farmakokinetike so predstavljeni v spodnji preglednici skupaj s podatki za intravensko dajanje IG 10 %, ki so bili dobljeni v isti študiji.
English: The recommended infusion rate given in section 4.2 should be adhered to.
Slovenian: Upoštevati morate priporočeno hitrost infundiranja, ki je navedena v poglavju 4.2.
English: The most frequent adverse reactions reported during post-marketing use of recombinant human hyaluronidase in similar formulations administered subcutaneously for the dispersion and absorption of subcutaneously administered fluids or medicinal products have been mild local infusion site reactions such as erythema and pain.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali po pridobitvi dovoljenja za promet z rekombinantno humano hialuronidazo v podobnih formulacijah, ki se dajejo subkutano za razširitev in absorpcijo subkutano danih tekočin ali zdravil, so bile blage lokalne reakcije na mestu infundiranja, kot sta eritem in bolečina.
English: • If more than one vial is required for a full dose, spike subsequent vials after the first vial has been fully administered.
Slovenian: • Če za celoten odmerek potrebujete več kot eno vialo, predrite naslednje viale, ko končate z dajanjem prve viale.
English: The overall rate of infections was less during HyQvia administration than during the three months intravenous administration of IG 10%: the point estimate of the annualized rate of all infections was 2.97 (95% CI: 2.51 to 3.47) for HyQvia and 4.51 (95% CI: 3.50 to 5.69) for intravenous IG 10% infusions.
Slovenian: Med dajanjem zdravila HyQvia je bila skupna stopnja okužb nižja kot v treh mesecih intravenskega dajanja IG 10 %: točkovna ocena letne stopnje vseh okužb je bila 2,97 (95-% IZ: od 2,51 do 3,47) za zdravilo HyQvia in 4,51 (95-% IZ: od 3,50 do 5,69) za intravenske infuzije IG 10 %.
English: A-1221 Vienna
Slovenian: A-1221 Dunaj
English: Do not infuse a double dose of HyQvia to make up for a missed dose.
Slovenian: Ne infundirajte dvojnega odmerka zdravila HyQvia, če ste pozabili vzeti prejšnji odmerek.
English: Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.
Slovenian: Preobčutljivost na humane imunoglobuline, zlasti v zelo redkih primerih pomanjkljivosti IgA, ko ima bolnik razvita protitelesa proti IgA.
English: If the patient tolerates the initial infusions at the full dose per site and maximum rate, an increase in the rate of successive infusions may be considered at the discretion of the physician and the patient.
Slovenian: Če bolnik prenaša začetne infuzije celotnega odmerka na mesto in pri največji hitrosti, se hitrost naslednjih infuzij po presoji zdravnika in bolnika lahko poveča.
English: • Repeat Step 6, if more than one vial of recombinant human hyaluronidase is needed for your dose.
Slovenian: • Ponovite 6. korak, če za vaš odmerek potrebujete več kot eno vialo rekombinantne humane hialuronidaze.
English: In cases where more than one vial of the medicinal product IG 10% or recombinant human hyaluronidase is required to obtain the required dose of the infusion, the IG 10% and/or recombinant human hyaluronidase should be prepared separately in appropriate solution containers before administration.
Slovenian: Če je za doseganje želenega odmerka infuzije potrebna več kot ena viala zdravila IG 10 % ali rekombinantne humane hialuronidaze, IG 10 % in/ali rekombinantno humano hialuronidazo pred dajanjem pripravite ločeno v primernih vsebnikih za tekočine.
English: Local reactions observed during the pivotal clinical study include mild swelling of the site (present in most infusions) due to the large volumes infused, but in general were not considered an adverse reaction unless they caused discomfort.
Slovenian: Lokalne reakcije, ki so bile ugotovljene med ključno klinično študijo, so obsegale blago otekanje mesta (za večino infuzij) zaradi velikih infundiranih volumnov, vendar se običajno niso štele za neželeni učinek, če niso povzročile nelagodja.
English: Doctors are aware of these possible side effects and will monitor you during and after the initial infusions.
Slovenian: Zdravniki se zavedajo teh možnih neželenih učinkov, zato vas bodo spremljali tekom prvih infuzij in po njih.
English: Sometimes your doctor may recommend that larger doses are split and given at two sites at once.
Slovenian: Morda vam bo zdravnik priporočil razdelitev večjega odmerka, tako da se ga da sočasno na dve mesti.
English: • If possible, combine all of the recombinant human hyaluronidase needed for the entire dose of IgG into the same syringe.
Slovenian: • Če je možno, združite vso količino rekombinantne humane hialuronidaze za celoten odmerek IgG v isto brizgo.
English: Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin
Slovenian: Ena viala po 25 ml vsebuje: 2,5 g humanega polispecifičnega imunoglobulina Ena viala po 50 ml vsebuje: 5 g humanega polispecifičnega imunoglobulina Ena viala po 100 ml vsebuje: 10 g humanega polispecifičnega imunoglobulina Ena viala po 200 ml vsebuje: 20 g humanega polispecifičnega imunoglobulina Ena viala po 300 ml vsebuje: 30 g humanega polispecifičnega imunoglobulina
English: It is depolymerized by the naturally occurring enzyme hyaluronidase.
Slovenian: Depolimerizira ga naravno prisotni encim hialuronidaza.
English: Certain side effects, such as headache, chills, or body aches, may be reduced by slowing the infusion rate.
Slovenian: Določeni neželeni učinki, kot so glavobol, mrzlica ali telesne bolečine, se lahko zmanjšajo z zmanjšanjem hitrosti infundiranja.
English: What HyQvia is and what it is used for What you need to know before you use HyQvia How to use HyQvia
Slovenian: Kaj je zdravilo HyQvia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo HyQvia Kako uporabljati zdravilo HyQvia Možni neželeni učinki
English: Important information about some of the ingredients of HyQvia
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila HyQvia
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: Izdelovalci teh zdravil kri in plazmo tudi obdelata, da se virusi inaktivirajo ali odstranijo.
English: The IG 10% component should be infused using a pump.
Slovenian: Komponento IG 10 % je treba infundirati s črpalko.
English: Data from the clinical trials of HyQvia show that serum IgG trough levels can be maintained by dosing regimens of 320 to 1,000 mg/kg body weight/4 weeks given at intervals of 3- or 4-weeks.
Slovenian: Podatki iz kliničnih preskušanj zdravila HyQvia kažejo, da se lahko najnižje serumske koncentracije IgG ohranjajo s shemo odmerjanja od 320 do 1.000 mg/kg telesne mase/4 tedne, ki se daje v tri-ali štiritedenskih presledkih.
English: • Recombinant human hyaluronidase (rHuPH20) Recombinant human hyaluronidase is a purified glycoprotein of 447 amino acids produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Slovenian: • Rekombinantna humana hialuronidaza (rHuPH20) Rekombinantna humana hialuronidaza je prečiščen glikoprotein iz 447 aminokislin, pridobljen iz celic jajčnika kitajskega hrčka (CHO) s tehnologijo rekombinantne DNA.
English: After opening, dispose of any unused solutions in the vials.
Slovenian: Po odprtju zavrzite neporabljeno raztopino v vialah.
English: Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae.
Slovenian: Prekinitev imunoglobulinskega zdravljenja lahko privede do remisije AMS v nekaj dneh brez posledic.
English: Antibodies against recombinant human hyaluronidase A total of 13 out of 83 subjects who participated in pivotal study developed an antibody capable of binding to recombinant human hyaluronidase (rHuPH20) at least once during the clinical study.
Slovenian: Protitelesa proti rekombinantni humani hialuronidazi Pri skupno 13 od 83 preiskovancev, ki so sodelovali v ključni študiji, so se vsaj enkrat med klinično študijo pojavila protitelesa, zmožna vezave na rekombinantno humano hialuronidazo (rHuPH20).
English: • Sodium (as chloride and as phosphate) The total sodium content of recombinant human hyaluronidase is 4.03 mg/ml.
Slovenian: • Natrij (v obliki natrijevega klorida in natrijevega fosfata) Skupna vsebnost natrija v rekombinantni humani hialuronidazi je 4,03 mg/ml.
English: Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg.
Slovenian: Rekombinantna humana hialuronidaza vsebuje 4,03 mg natrija na ml, največji dnevni odmerek pa je približno 120 mg.
English: Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Slovenian: Klinične izkušnje z imunoglobulini kažejo, da ni pričakovati neugodnih učinkov na potek nosečnosti ali na plod ali novorojenčka.
English: Subjects ≥ 40 kg
Slovenian: Bolniki ≥40 kg
English: These antibodies were not capable of neutralizing recombinant human hyaluronidase.
Slovenian: Ta protitelesa niso bila zmožna nevtralizacije rekombinantne humane hialuronidaze.
English: If you think that you used more HyQvia than you should, speak to your doctor as soon as possible.
Slovenian: Če menite, da ste uporabili večji odmerek zdravila HyQvia, kot bi smeli, se čimprej posvetujte s svojim zdravnikom.
English: Your doctor or nurse will first infuse HyQvia slowly, and carefully monitor you throughout the first infusions so that any allergic reaction can be detected and treated immediately.
Slovenian: Zdravnik ali medicinska sestra bosta zdravilo HyQvia prvič infundirala počasi in vas bosta tekom prvih infuzij natančno opazovala, da vidita, ali se pojavijo kakršne koli alergijske reakcije, ter vas nemudoma zdravila.
English: Pharmacotherapeutic group (human normal immunoglobulin): immune sera and immunoglobulins: immunoglobulins, normal human, ATC code: J06BA01
Slovenian: Farmakoterapevtska skupina (humani polispecifični imunoglobulin): imunski serumi in imunoglobulini: imunoglobulini humanega izvora, oznaka ATC: J06BA01
English: Solution for infusion (infusion).
Slovenian: Raztopina za infundiranje (infuzijo).
English: If you use more HyQvia than you should
Slovenian: Če ste uporabili večji odmerek zdravila HyQvia, kot bi smeli
English: The recommended starting dose is one that supplies 400 to 800 mg of active substance per kg of bodyweight per month.
Slovenian: Priporočeni začetni odmerek je takšen, da zagotovi od 400 do 800 mg učinkovine na kg telesne mase na mesec.
English: The following ADRs are not listed but also calculated in the frequency for Local reactions: feeling hot, infusion site paresthesia.
Slovenian: Naslednji neželeni učinki niso navedeni, a so upoštevani pri pogostnosti lokalnih reakcij: občutek vročine, parestezija na mestu infundiranja.
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Slovenian: Humani polispecifični imunoglobulin vsebuje protitelesa IgG, ki so prisotna v normalni populaciji.
English: You may experience a sudden fall in blood pressure and, in isolated cases, anaphylactic shock.
Slovenian: Lahko se pojavi nenaden padec krvnega tlaka in v posameznih primerih, anafilaktični šok.
English: Patients may experience side effects (for example dizziness or nausea) during treatment with HyQvia that might affect the ability to drive and use machines.
Slovenian: Pri bolnikih se lahko med zdravljenjem z zdravilom HyQvia pojavijo neželeni učinki (npr. omotica in siljenje na bruhanje), ki lahko vplivajo na sposobnost vožnje in upravljanja strojev.
English: The syringe tip will be pointing upward.
Slovenian: Konica brizge bo obrnjena gor.
English: HyQvia Median (95% Cl) N=60
Slovenian: HyQvia Mediana (95-odstotni IZ) N=60
English: • If patient is at high risk for any allergic reactions, the product should be administered only where supportive care is available for life threatening reactions.
Slovenian: • Bolnikom z velikim tveganjem za kakršno koli alergijsko reakcijo je treba zdravilo dajati le če je na voljo podporno zdravljenje v primeru smrtno nevarne reakcije.
English: Posology The dose and dose regimen are dependent on the indication.
Slovenian: Odmerjanje Odmerek in shema odmerjanja sta odvisna od indikacije.
English: Secure the needle to the skin:
Slovenian: Injekcijsko iglo pritrdite na kožo:
English: In the beginning your doctor or nurse will use a slow infusion speed and gradually increase it during the first infusion and in the following infusions.
Slovenian: Na začetku bosta zdravnik ali medicinska sestra uporabila majhno hitrost infundiranja, nato pa jo bosta postopno povečevala med prvim in naslednjimi infundiranji.
English: The first infusion of HyQvia should be given one week after the last treatment with the previous immunoglobulin.
Slovenian: Prvo infundiranje zdravila HyQvia opravite en teden po dajanju prejšnjega imunoglobulina.
English: Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester.
Slovenian: Dokazali so, da zdravila z imunoglobulini prehajajo placento, kar se še stopnjuje v tretjem trimestru.
English: Hyaluronan is a polysaccharide found in the intercellular matrix of the connective tissue.
Slovenian: Hialuronan je polisaharid, ki ga najdemo v medceličnem matriksu vezivnega tkiva.
English: Subjects < 40 kg
Slovenian: Bolniki <40 kg
English: • Colour: o The recombinant human hyaluronidase should be clear and colourless.
Slovenian: • Barva:  Raztopina rekombinantne humane hialuronidaze mora biti bistra in brezbarvna.
English: Very common side effects (may affect more than 1 in 10 infusions):
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri več največ 1 od 10 infuzij):
English: Home treatment Before you start home treatment you should assign a person as guardian.
Slovenian: Zdravljenje doma Pred začetkom zdravljenja doma morate določiti skrbnika.
English: No temporal association between adverse reactions and the presence of anti-rHuPH20 antibodies could be demonstrated.
Slovenian: Časovne povezave med neželenimi učinki in prisotnostjo protiteles proti rHuPH20 niso dokazali.
English: First Two Infusions (ml/hour/infusion site)
Slovenian: Prvi dve infuziji (ml/uro/mesto infundiranja)
English: 1.4 (1.2 to 1.4)
Slovenian: 1,4 (1,2 do 1,4)
English: Therefore, after receiving HyQvia, you may have to wait for up to 3 months before receiving certain vaccines.
Slovenian: Zato morate po prejemanju zdravila HyQvia počakati do 3 mesece, preden prejmete določena cepiva.
English: Patients should be reminded to report any chronic inflammation, nodules or inflammation that occurs at the infusion site and lasts more than a few days.
Slovenian: Bolnike je treba opozoriti, da poročajo o morebitnem kroničnem vnetju, vozličih ali vnetju, ki se pojavi na mestu infundiranja in traja dlje kot nekaj dni.
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of opsonising and neutralizing antibodies against infectious agents.
Slovenian: Humani polispecifični imunoglobulin vsebuje predvsem imunoglobulin G (IgG) s široko paleto opsonizirajočih in nevtralizirajočih protiteles proti povzročiteljem nalezljivih bolezni.
English: • If known anaphylactic or severe hypersensitivity to human immunoglobulin exists, it should be noted in the patient records.
Slovenian: • Dokazano anafilaksijo ali hudo preobčutljivost na humane imunoglobuline je treba zabeležiti v bolnikovo kartoteko.
English: The median number of infusion sites per month for HyQvia was 1.09, which is slightly lower than the median number of intravenous IG 10% infusion sites used in this study (1.34), and considerably lower than the median number of infusion sites in the study of subcutaneous administration of IG 10% (21.43).
Slovenian: Mediana mest infundiranja na mesec je bila za zdravilo HyQvia 1,09 in je nekoliko manjša od mediane mest infundiranja intravenskega IG 10 % v tej študiji (1,34) in bistveno manjša od mediane mest subkutanega dajanja IG 10 % (21,43).
English: This also applies to unknown or emerging viruses and other pathogens.
Slovenian: To se nanaša tudi na doslej še neznane ali porajajoče se viruse in druge povzročitelje bolezni.
English: • patients with an inborn inability or reduced ability to produce antibodies (primary immunodeficiencies).
Slovenian: • bolniki s prirojeno nezmožnostjo ali zmanjšano zmožnostjo tvorbe protiteles (primarno imunsko pomanjkljivostjo),
English: Do not mix the two vials prior to administration.
Slovenian: Obeh vial pred uporabo ne zmešajte.
English: Only two instances of local adverse reactions were severe, infusion site pain and infusion site swelling.
Slovenian: Samo dva primera lokalnih neželenih učinkov sta bila huda, bolečina na mestu infundiranja in oteklina na mestu infundiranja.
English: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
Slovenian: • katerem od sindromov primarne imunske pomanjkljivosti z okvarjeno tvorbo protiteles (glejte poglavje 4.4),
English: Immunoglobulins are also known as antibodies and are found in healthy people's blood.
Slovenian: Imunoglobuline imenujemo tudi protitelesa in so prisotna v krvi zdravih oseb.
English: The full contents of the recombinant human hyaluronidase vial should be administered regardless of whether the full content of the IG 10% vial is administered.
Slovenian: Aplicirati morate celotno vsebino viale z rekombinantno humano hialuronidazo, ne glede na to, ali aplicirate tudi celotno vsebino viale z IG 10 %.
English: Do not use this medicine if the solutions are cloudy or have particles or deposits.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da sta raztopini motni ali vsebujeta delce ali usedlino.
English: Caution should be exercised in patients with pre-existing risk factors for thromboembolic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity).
Slovenian: Previdnost je potrebna pri bolnikih z obstoječimi dejavniki tveganja za tromboembolične dogodke (kot so visoka starost, hipertenzija, sladkorna bolezen in žilna bolezen ali trombotični dogodek v anamnezi, bolniki s pridobljeno ali prirojeno trombofilijo, bolniki po daljšem obdobju imobilizacije, zelo hipovolemični bolniki, bolniki z boleznimi, ki povečajo viskoznost krvi).