FrancophonIA/ELRC3.0 huggingface dataset:
English: • Expiration date: Do not use beyond expiration date.
Slovenian: • Datum izteka roka uporabnosti: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti.
English: The IG 10% component provides the therapeutic effect of this medicinal product.
Slovenian: Komponenta IG 10 % zagotavlja terapevtski učinek tega zdravila.
English: Your doctor may also adjust your dose depending on your response to treatment.
Slovenian: Zdravnik vam lahko tudi spremeni odmerek glede na vaš odziv na zdravljenje.
English: These include:
Slovenian: Sem sodijo:
English: If patients were previously on a 3-week dosing regimen, increasing the interval to 4-weeks can be accomplished by administering the same weekly equivalents.
Slovenian: Če so bili bolniki predhodno na tritedenski shemi odmerjanja, lahko podaljšanje presledka na štiri tedne opravite z dajanjem enakih tedenskih ekvivalentov.
English: The listed warnings and precautions apply both to adults and children.
Slovenian: Našteta opozorila in previdnostni ukrepi veljajo tako za odrasle kot za otroke.
English: Record the infusion:
Slovenian: Zabeležite infuzijo:
English: 66 patients who completed the pivotal phase 3 study participated in an extension study (160902) for the evaluation of long-term safety, tolerability and efficacy of HyQvia in PID.
Slovenian: 66 bolnikov, ki so zaključili ključno študijo 3. faze, je sodelovalo v podaljšani študiji (160902) za oceno dolgoročne varnosti, prenašanja in učinkovitosti zdravila HyQvia pri PID.
English: Interval/Minutes
Slovenian: Interval/minute
English: ► Tell your doctor about your treatment with HyQvia before any blood test.
Slovenian: ► Zdravnika obvestite o zdravljenju z zdravilom HyQvia pred vsako krvno preiskavo.
English: Glycine, water for injections.
Slovenian: glicin, voda za injekcije.
English: Ask your doctor or pharmacist or nurse if another needle size would be more appropriate for you.
Slovenian: Zdravnika, farmacevta ali medicinsko sestro vprašajte, ali bi bila za vas primernejša igla druge velikosti.
English: Any change of needle size would have to be supervised by the treating physician.
Slovenian: Vsako spremembo velikosti igle mora nadzorovati lečeči zdravnik.
English: It is very important to infuse the medicine at the correct speed.
Slovenian: Zelo pomembna je ustrezna hitrost infundiranja tega zdravila.
English: Your treatment will be started by a doctor or nurse experienced in treating patients with a weak immune system and in guiding patients for home treatment.
Slovenian: Zdravljenje bosta uvedla zdravnik ali medicinska sestra z izkušnjami pri zdravljenju bolnikov z oslabljenim imunskim sistemom in pri usmerjanju bolnikov pri zdravljenju doma.
English: The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm.
Slovenian: Ta protitelesa imajo potencial, da navzkrižno reagirajo z endogenim PH20, za katerega je znano, da je izražen v testisih, epididmisu in spermi odraslih.
English: HyQvia is prescribed as replacement therapy to patients who do not have sufficient antibodies, including the following groups:
Slovenian: Zdravilo HyQvia predpišemo kot nadomestno zdravljenje bolnikom, ki nimajo dovolj protiteles, vključno z naslednjimi skupinami:
English: The medicine works in exactly the same way as the immunoglobulins naturally present in the blood.
Slovenian: Zdravilo deluje povsem enako kakor imunoglobulini, ki so naravno prisotni v krvi.
English: • When treatment is given at home, support from another responsible person should be available for treating adverse reactions or to summon help should a serious adverse reaction occur.
Slovenian: • Če se zdravljenje izvaja doma, mora biti na voljo druga odgovorna oseba za zdravljenje neželenih reakcij ali klicanje pomoči, če bi prišlo do hudega neželenega učinka.
English: Live attenuated virus vaccines
Slovenian: Živa oslabljena virusna cepiva
English: HyQvia was evaluated in 24 paediatric patients, including 13 patients between 4 and < 12 years and 11 between 12 and < 18 years, who were treated for up to 3.3 years with an overall safety experience equivalent to 48.66 patient-years (as described in section Clinical efficacy and safety).
Slovenian: Zdravilo HyQvia je bilo ocenjeno pri 24 pediatričnih bolnikih, vključno s 13 bolniki, starimi od 4 do <12 let, in 11 bolniki, starimi od 12 do <18 let, ki so bili zdravljeni do 3,3 leta, s splošno izkušnjo glede varnosti enakovredni 48,66 bolnikovih let (kakor je opisano v poglavju Klinična učinkovitost in varnost).
English: The most frequently reported systemic ARs were headache, fatigue and pyrexia.
Slovenian: Najpogosteje navedeni sistemski neželeni učinki so bili glavobol, utrujenost in pireksija.
English: The table presented below is according to the MedDRA System Organ Classification (SOC and Preferred Term Level).
Slovenian: Spodnja tabela prikazuje razvrstitev glede na organske sisteme po MedDRA (SOC-System Organ Class in raven prednostnega profila).
English: During the infusion you must look out for first signs of side effects (for further details see section 4, “Possible side effects”).
Slovenian: Med infundiranjem morate biti pozorni na zgodnje znake neželenih učinkov (za podroben opis glejte poglavje 4, ”Možni neželeni učinki”).
English: They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution.
Slovenian: Zlasti se lahko pojavijo pri bolnikih s protitelesi proti IgA, ki jih morate zdraviti še posebej previdno.
English: Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability so that the patient receives the same weekly equivalent dose.
Slovenian: Pogostnost in število infuzijskih mest prilagodite glede na volumen, skupni čas infundiranja in prenašanje, tako da bolnik prejme enak tedenski enakovredni odmerek.
English: The pharmacokinetics of HyQvia were evaluated in a clinical study in patients with PID aged 12 years and older.
Slovenian: Farmakokinetika zdravila HyQvia je bila ocenjena v klinični študiji pri bolnikih s PID, ki so bili stari 12 let in več.
English: Aseptic meningitis syndrome (AMS)
Slovenian: Sindrom aseptičnega meningitisa (AMS)
English: • The medicinal product is for subcutaneous use only, do not administer intravenously.
Slovenian: • Zdravilo je namenjeno samo za subkutano uporabo, ne dajajte ga intravensko.
English: The safety of HyQvia was evaluated in 4 clinical studies (160602, 160603, 160902, and 161101) in 124 unique patients with PID receiving 3,202 infusions.
Slovenian: Varnost zdravila HyQvia je bila ocenjena v kliničnih študijah (160602, 160603, 160902 in 161101) pri 124 edinstvenih bolnikih s PID, ki so prejeli 3.202 infuziji.
English: Prepare the pump: Follow the manufacturer's instructions for preparing the pump.
Slovenian: Pripravite črpalko: Pri pripravi črpalke upoštevajte navodila izdelovalca.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HyQvia in one or more subsets of the paediatric population in treatment of primary immunodeficiency as model for replacement therapy.
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom HyQvia za eno ali več podskupin pediatrične populacije za zdravljenje primarne imunske pomanjkljivosti kot modela za nadomestno zdravljenje.
English: In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience (frequency of these reactions is not known (cannot be estimated from the available data)):
Slovenian: Poleg neželenih učinkov, ki so jih opazili v kliničnih preskušanjih, so v obdobju trženja zdravila poročali o naslednjih neželenih učinkih (pogostnost teh učinkov ni znana (je ni mogoče oceniti iz razpoložljivih podatkov)):
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Slovenian: Bolniki, pri katerih se med zdravljenjem pojavijo neželeni učinki, morajo pred vožnjo ali upravljanjem strojev počakati, da ti izzvenijo.
English: Your doctor or nurse will advise you on the appropriate infusion speed to use when you are infusing HyQvia at home (see section 3, “How to use HyQvia”).
Slovenian: Zdravnik ali medicinska sestra vam bosta svetovala glede ustrezne hitrosti infundiranja, ko si boste zdravilo HyQvia infundirali doma (glejte poglavje 3, ”Kako uporabljati zdravilo HyQvia”).
English: Monitoring during infusion
Slovenian: Spremljanje med infundiranjem
English: AMS may occur more frequently in association with high-dose (2 g/kg) intravenous immunoglobulin treatment.
Slovenian: AMS se lahko pojavlja pogosteje v povezavi z velikimi odmerki (2 g/kg) intravenskih imunoglobulinskih zdravil.
English: Name and address of the manufacturers of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
English: If a woman becomes pregnant, the treating physician should encourage her to participate in the pregnancy registry.
Slovenian: Če bolnica zanosi, naj jo lečeči zdravnik spodbudi k vključitvi v register nosečnosti.
English: • ensuring that patients are carefully monitored for any symptoms throughout the infusion period.
Slovenian: • poskrbimo, da se bolniki skrbno spremljajo glede pojava morebitnih simptomov ves čas trajanja infuzij.
English: Home treatment
Slovenian: Zdravljenje doma
English: • Check each vial of HyQvia before using:
Slovenian: • Pred uporabo na vsaki viali zdravila HyQvia preverite naslednje:
English: The other ingredients of this vial are glycine and water for injections.
Slovenian: Drugi sestavini v tej viali sta glicin in voda za injekcije.
English: There were two instances of transient genital oedema, one considered severe, that resulted from diffusion of the medicinal product from the infusion site in the abdomen.
Slovenian: Ugotovili so dva primera prehodnega genitalnega edema (eden se je štel za resnega), ki sta bila posledica difuzije zdravila iz mesta infundiranja v abdomen.
English: MedDRA System Organ Class (SOC)
Slovenian: Organski sistem, MedDRA (SOC)
English: Your doctor will calculate the correct dose for you based on your body weight, any previous treatment you may have received and your response to treatment.
Slovenian: Zdravnik bo preračunal pravilni odmerek za vas na osnovi vaše telesne mase, predhodno prejetih zdravljenj in vašega odziva na zdravljenje.
English: The following pack sizes are available:
Slovenian: Na voljo so naslednja pakiranja:
English: This guardian should help you keep an eye on potential side effects.
Slovenian: Skrbnik vam bo pomagal paziti na možne neželene učinke.
English: The results of the study showed a rate of validated, acute, serious bacterial infections per year during HyQvia treatment of 0.025 (upper limit of the one-sided 99% confidence interval 0.046).
Slovenian: Rezultati študije so pokazali stopnjo potrjenih akutnih resnih bakterijskih okužb na leto med zdravljenjem z zdravilom HyQvia 0,025 (zgornja meja enostranskega 99-% intervala zaupanja 0,046).
English: Haemolytic anaemia
Slovenian: Hemolitična anemija
English: IVIG 10% Median (95% Cl) N=68
Slovenian: IVIG 10 % Mediana (95-odstotni IZ) N=68
English: • Please also see section 2 of this leaflet about the risk of allergic reactions and using HyQvia at home.
Slovenian: • Glejte poglavje 2 tega navodila za uporabo o tveganju alergijskih reakcij in uporabi zdravila
English: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned condition.
Slovenian: Odmerjanje pri otrocih in mladostnikih (0-18 let) se ne razlikuje od odmerjanja pri odraslih, saj je odmerek odvisen od telesne mase in se prilagaja glede na klinične rezultate zgoraj opisane bolezni.
English: If two sites are used, the two infusion sites should be on contra lateral sides of the body.
Slovenian: Če uporabljate dve mesti, naj bosta mesti infundiranja na nasprotnih lateralnih straneh telesa.
English: If you become pregnant when using HyQvia, you should discuss with your doctor the possibility of participating in a pregnancy registry in order to collect data on your pregnancy and the development of the baby.
Slovenian: Če zanosite v času zdravljenja z zdravilom HyQvia, se z zdravnikom posvetujte o morebitni vključitvi v register nosečnosti, da se bodo zbirali podatki o vaši nosečnosti in razvoju otroka.
English: • Note: Your healthcare professional may recommend using a “Y” connector (for more than one site) or other needle set configuration.
Slovenian: • Opomba: Zdravstveni delavec vam bo morda priporočil uporabo priključka ”Y” (za več kot eno mesto infundiranja) ali drugačno konfiguracijo cevk črpalke.
English: After infusion of immunoglobulins, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Slovenian: Po infundiranju imunoglobulinov lahko prehodno povečanje vrednosti različnih pasivno prenesenih protiteles v bolnikovi krvi povzroči lažno pozitivne izvide seroloških preiskav.
English: The recombinant human hyaluronidase facilitates the dispersion and absorption of IG 10%.
Slovenian: Rekombinantna humana hialuronidaza pospeši širjenje in absorpcijo IG 10 %.
English: There are currently no clinical safety data for HyQvia on fertility available.
Slovenian: Trenutno podatki o klinični varnosti zdravila HyQvia za plodnost niso na razpolago.
English: This also applies to any unknown or emerging viruses or other types of infections.
Slovenian: To se nanaša tudi na doslej še neznane ali porajajoče se viruse in druge vrste okužb.
English: No appreciable differences in the pharmacodynamic effects or efficacy and safety of HyQvia were observed between paediatric patients and adults.
Slovenian: Pomembnih razlik v farmakodinamičnih učinkih, učinkovitosti ali varnosti zdravila HyQvia med pediatričnimi bolniki in odraslimi bolniki niso opazili.
English: Animal studies do not indicate direct or indirect harmful effects of recombinant human hyaluronidase with respect to reproductive potential at the doses used for facilitating administration of IG 10% (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov rekombinantne humane hialuronidaze na sposobnost razmnoževanja v odmerkih, ki se uporabljajo za pospešeno dajanje IG 10 % (glejte poglavje 5.3).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Remainder of infusion
Slovenian: Preostanek infuzije
English: However, antibodies to hyaluronidase did not influence reproduction following immunization of mice, rabbits, sheep, or cynomolgus monkeys.
Slovenian: Vendar protitelesa proti hialuronidazi niso vplivala na razmnoževanje po imunizaciji pri miših, kuncih, ovcah in opicah vrste cynomolgus.
English: Pharmacokinetic Parameters of HyQvia Compared to Intravenous Administration of IG 10% Parameter
Slovenian: Farmakokinetični parametri zdravila HyQvia v primerjavi z intravenskim dajanjem IG 10 % Parameter
English: Regular and sufficient doses of HyQvia can raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy).
Slovenian: Redni in zadostni odmerki zdravila HyQvia lahko zvišajo nenormalno nizke ravni protiteles v vaši krvi na normalne ravni (nadomestno zdravljenje).
English: • Remove blue protective caps to expose the vial stoppers.
Slovenian: • Odstranite modri zaščitni zaporki, da odkrijete zamaška vial.
English: Hypersensitivity to IG 10%
Slovenian: Preobčutljivost na IG 10 %
English: A-1221 Vienna, Austria
Slovenian: A-1221 Dunaj, Avstrija
English: Other medicines and HyQvia
Slovenian: Druga zdravila in zdravilo HyQvia
English: If you forget to use HyQvia
Slovenian: Če ste pozabili uporabiti zdravilo HyQvia
English: HyQvia is used in patients with a weak immune system, who do not have enough antibodies in their blood and tend to get frequent infections.
Slovenian: Zdravilo HyQvia se uporablja za bolnike s šibkim imunskim sistemom, ki nimajo dovolj protiteles v svoji krvi in so dovzetni za pogoste okužbe.
English: It has a distribution of IgG subclasses closely proportional to that in native human plasma.
Slovenian: Porazdelitev podrazredov IgG je zelo podobna porazdelitvi teh podskupin v nativni človeški plazmi.
English: The effects of long-term use of recombinant human hyaluronidase on pregnancy, breast-feeding and fertility are currently not known.
Slovenian: Učinki dolgoročne uporabe rekombinantne humane hialuronidaze na nosečnost, dojenje in plodnost trenutno niso znani.
English: All other patients should be observed for at least 20 minutes after the administration.
Slovenian: Vse druge bolnike je treba opazovati najmanj 20 minut po prejemu infuzije.
English: Baxalta Innovations GmbH A-1221 Vienna, Austria
Slovenian: Baxalta Innovations GmbH A-1221 Dunaj, Avstrija
English: ► If you experience a severe side effect, you or your guardian must seek emergency treatment immediately.
Slovenian: ► Če se pri vas pojavi hud neželen učinek, morate vi ali vaš skrbnik nemudoma poiskati nujno medicinsko pomoč.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Slovenian: Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, so med drugim: selekcija darovalcev, presejalno testiranje posameznih enot darovane krvi in združene plazme na specifične markerje okužbe ter vključitev učinkovitih proizvodnih postopkov za inaktivacijo/odstranitev virusov.
English: Patients on self-home treatment and/or their guardian should also be trained to detect early signs of hypersensitivity reactions.
Slovenian: Bolnike, ki se zdravijo sami doma, in/ali njihove skrbnike morate poučiti o tem, kako spoznati zgodnje znake preobčutljivostnih reakcij.
English: For the 1.25 mL recombinant human hyaluronidase vial size use a 18-22 gauge needle to withdraw the contents of the vial to prevent stopper push through or coring; for all other vial sizes a needle or needle-less device may be used to withdraw the contents of the vial.
Slovenian: Pri velikosti viale z rekombinantno humano hialuronidazo 1,25 ml za odvzem vsebine iz viale uporabite iglo velikosti 18−22, da preprečite prebitje in luščenje zamaška; pri vseh ostalih velikostih vial lahko za odvzem vsebine iz viale uporabite pripomoček z iglo ali brez igle.
English: What HyQvia is and what it is used for
Slovenian: Kaj je zdravilo HyQvia in za kaj ga uporabljamo
English: Hypersensitivity to the active substance (IgG) or to any of the excipients listed in section 6.1 (see section 4.4).
Slovenian: Preobčutljivost na učinkovino (IgG) ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
English: • Write down the date, time, dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion.
Slovenian: • Zapišite datum, uro, mesto(a) infundiranja (kar vam bo v pomoč pri menjavi mest) in morebitne reakcije po vsaki infuziji.
English: Do not use heating devices including microwaves.
Slovenian: Ne uporabljajte grelnih naprav, vključno z mikrovalovnimi pečicami.
English: Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis.
Slovenian: Prejemnike imunoglobulinskega zdravila morate spremljati za klinične znake in simptome hemolize.
English: Infections and infestations: Meningitis aseptic
Slovenian: Infekcijske in parazitske bolezni: aseptični meningitis
English: What you need to know before you use HyQvia
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo HyQvia
English: Once the doctor or nurse has found the right dose and speed of infusion for you, you may be allowed to give the treatment to yourself at home.
Slovenian: Ko bosta zdravnik ali medicinska sestra ugotovila pravi odmerek in hitrost infundiranja za vas, vam bosta lahko dovolila, da se začnete zdraviti sami doma.
English: The vial of immunoglobulins has been prepared from the blood of healthy people.
Slovenian: Viala imunoglobulinov je bila pripravljena iz krvi zdravih oseb.
English: The product should not be infused at or around an infected or acutely inflamed area due to the potential risk of spreading a localized infection.
Slovenian: Zdravila se ne sme infundirati v okuženo oz. akutno vneto področje ali v njegovo bližino zaradi nevarnosti širjenja lokalizirane okužbe.
English: It is recommended that the recombinant human hyaluronidase component be administered at a constant rate and that the rate of administration of the IG 10% should not be increased above the recommended rates, particularly when the patient has just started with HyQvia therapy.
Slovenian: Priporočljivo je, da komponento z rekombinantno humano hialuronidazo uporabite s stalno hitrostjo in da hitrosti dajanja IG 10 % ne povečujete preko priporočenih hitrosti, zlasti če je bolnik šele začel zdravljenje z zdravilom HyQvia.
English: Seventy eight (78) of 83 (94%) subjects attained the same 3- or 4-week dosing whereas one decreased from 4 to 3 weeks, one from 4 to 2 weeks and one from 3 to 2 weeks (2 subjects withdrew during the titration period).
Slovenian: Oseminsedemdeset (78) od 83 (94 %) preiskovancev je ohranilo enako tri-oz. štiritedensko odmerjanje, odmerjanje se je zmanjšalo v enem primeru iz štiritedenskega na tritedensko, v enem primeru iz štiritedenskega na dvotedensko in v enem primeru iz tritedenskega na dvotedensko (2 preiskovanca sta prekinila sodelovanja v obdobju titriranja).
English: • The human normal immunoglobulin 10% of HyQvia may be infused either o by pooling from the vials either into larger syringe (a) or an infusion bag (b) as directed by your healthcare professional, depending upon the pump to be used; or o directly from the IG vial (c).
Slovenian: • Humani polispecifični imunoglobulin 10 % zdravila HyQvia lahko infundirate bodisi  z združevanjem vial v večjo brizgo (a) ali v infuzijsko vrečo (b) po navodilih zdravstvenega delavca, odvisno od uporabljene črpalke, bodisi  neposredno iz viale IG (c).
English: HyQvia can be used to administer a full therapeutic dose in one to two sites up to every four weeks.
Slovenian: Zdravilo HyQvia se lahko uporablja za dajanje celotnega terapevtskega odmerka na eno ali dve mesti enkrat na do štiri tedne.
English: The safety of IG 10% has been demonstrated in several non-clinical studies.
Slovenian: Varnost IG 10 % so dokazali v več predkliničnih študijah.
English: It is strongly recommended that every time you use HyQvia, the following data are recorded in your treatment diary: - the date of administration, - the batch number of the medicine, and - the injected volume, flow rate, the number and location of infusion sites.
Slovenian: Zelo priporočljivo je, da si vsakič, ko prejmete odmerek zdravila HyQvia, v dnevnik zdravljenja zabeležite naslednje podatke: - datum infuzije zdravila, - serijo zdravila in - injicirani volumen, hitrost infundiranja in število mest infundiranja ter njihov položaj.
English: You must carefully follow your doctor's instructions regarding the dose, infusion speed and schedule for infusing HyQvia so that your treatment works for you.
Slovenian: Natančno upoštevajte zdravnikova navodila glede odmerka, hitrosti infundiranja in urnika infundiranja zdravila HyQvia tako, da vam bo zdravljenje pomagalo.
English: HyQvia must not be given intravenously or intramuscularly.
Slovenian: Zdravila HyQvia ne smete dajati intravensko ali intramuskularno.