natgillin/translations-raw huggingface dataset:
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)): 
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)):
Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines. 
Bolniki, pri katerih se med zdravljenjem pojavijo neželeni učinki, morajo pred vožnjo ali upravljanjem strojev počakati, da ti izzvenijo.
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”). 
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”).
Monitoring during infusion 
Spremljanje med infundiranjem
AMS may occur more frequently in association with high-dose (2 g/kg) intravenous immunoglobulin treatment. 
AMS se lahko pojavlja pogosteje v povezavi z velikimi odmerki (2 g/kg) intravenskih imunoglobulinskih zdravil.
Name and address of the manufacturers of the biological active substance(s) 
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
If a woman becomes pregnant, the treating physician should encourage her to participate in the pregnancy registry. 
Če bolnica zanosi, naj jo lečeči zdravnik spodbudi k vključitvi v register nosečnosti.
• ensuring that patients are carefully monitored for any symptoms throughout the infusion period. 
• poskrbimo, da se bolniki skrbno spremljajo glede pojava morebitnih simptomov ves čas trajanja infuzij.
Home treatment 
Zdravljenje doma
• Check each vial of HyQvia before using: 
• Pred uporabo na vsaki viali zdravila HyQvia preverite naslednje:
The other ingredients of this vial are glycine and water for injections. 
Drugi sestavini v tej viali sta glicin in voda za injekcije.
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. 
Ugotovili so dva primera prehodnega genitalnega edema (eden se je štel za resnega), ki sta bila posledica difuzije zdravila iz mesta infundiranja v abdomen.
MedDRA System Organ Class (SOC) 
Organski sistem, MedDRA (SOC)
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. 
Zdravnik bo preračunal pravilni odmerek za vas na osnovi vaše telesne mase, predhodno prejetih zdravljenj in vašega odziva na zdravljenje.
The following pack sizes are available: 
Na voljo so naslednja pakiranja:
This guardian should help you keep an eye on potential side effects. 
Skrbnik vam bo pomagal paziti na možne neželene učinke.
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). 
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).
Haemolytic anaemia 
Hemolitična anemija
IVIG 10% Median (95% Cl) N=68 
IVIG 10 % Mediana (95-odstotni IZ) N=68
• Please also see section 2 of this leaflet about the risk of allergic reactions and using HyQvia at home. 
• Glejte poglavje 2 tega navodila za uporabo o tveganju alergijskih reakcij in uporabi zdravila
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. 
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.
If two sites are used, the two infusion sites should be on contra lateral sides of the body. 
Če uporabljate dve mesti, naj bosta mesti infundiranja na nasprotnih lateralnih straneh telesa.
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. 
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.
• Note: Your healthcare professional may recommend using a “Y” connector (for more than one site) or other needle set configuration. 
• Opomba: Zdravstveni delavec vam bo morda priporočil uporabo priključka ”Y” (za več kot eno mesto infundiranja) ali drugačno konfiguracijo cevk črpalke.
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. 
Po infundiranju imunoglobulinov lahko prehodno povečanje vrednosti različnih pasivno prenesenih protiteles v bolnikovi krvi povzroči lažno pozitivne izvide seroloških preiskav.
The recombinant human hyaluronidase facilitates the dispersion and absorption of IG 10%. 
Rekombinantna humana hialuronidaza pospeši širjenje in absorpcijo IG 10 %.
There are currently no clinical safety data for HyQvia on fertility available. 
Trenutno podatki o klinični varnosti zdravila HyQvia za plodnost niso na razpolago.
This also applies to any unknown or emerging viruses or other types of infections. 
To se nanaša tudi na doslej še neznane ali porajajoče se viruse in druge vrste okužb.
No appreciable differences in the pharmacodynamic effects or efficacy and safety of HyQvia were observed between paediatric patients and adults. 
Pomembnih razlik v farmakodinamičnih učinkih, učinkovitosti ali varnosti zdravila HyQvia med pediatričnimi bolniki in odraslimi bolniki niso opazili.
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). 
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).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Remainder of infusion 
Preostanek infuzije
However, antibodies to hyaluronidase did not influence reproduction following immunization of mice, rabbits, sheep, or cynomolgus monkeys. 
Vendar protitelesa proti hialuronidazi niso vplivala na razmnoževanje po imunizaciji pri miših, kuncih, ovcah in opicah vrste cynomolgus.
Pharmacokinetic Parameters of HyQvia Compared to Intravenous Administration of IG 10% Parameter 
Farmakokinetični parametri zdravila HyQvia v primerjavi z intravenskim dajanjem IG 10 % Parameter
Regular and sufficient doses of HyQvia can raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy). 
Redni in zadostni odmerki zdravila HyQvia lahko zvišajo nenormalno nizke ravni protiteles v vaši krvi na normalne ravni (nadomestno zdravljenje).
• Remove blue protective caps to expose the vial stoppers. 
• Odstranite modri zaščitni zaporki, da odkrijete zamaška vial.
Hypersensitivity to IG 10% 
Preobčutljivost na IG 10 %
A-1221 Vienna, Austria 
A-1221 Dunaj, Avstrija
Other medicines and HyQvia 
Druga zdravila in zdravilo HyQvia
If you forget to use HyQvia 
Če ste pozabili uporabiti zdravilo HyQvia
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. 
Zdravilo HyQvia se uporablja za bolnike s šibkim imunskim sistemom, ki nimajo dovolj protiteles v svoji krvi in so dovzetni za pogoste okužbe.
It has a distribution of IgG subclasses closely proportional to that in native human plasma. 
Porazdelitev podrazredov IgG je zelo podobna porazdelitvi teh podskupin v nativni človeški plazmi.
The effects of long-term use of recombinant human hyaluronidase on pregnancy, breast-feeding and fertility are currently not known. 
Učinki dolgoročne uporabe rekombinantne humane hialuronidaze na nosečnost, dojenje in plodnost trenutno niso znani.
All other patients should be observed for at least 20 minutes after the administration. 
Vse druge bolnike je treba opazovati najmanj 20 minut po prejemu infuzije.
Baxalta Innovations GmbH A-1221 Vienna, Austria 
Baxalta Innovations GmbH A-1221 Dunaj, Avstrija
► If you experience a severe side effect, you or your guardian must seek emergency treatment immediately. 
► Če se pri vas pojavi hud neželen učinek, morate vi ali vaš skrbnik nemudoma poiskati nujno medicinsko pomoč.
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. 
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.
Patients on self-home treatment and/or their guardian should also be trained to detect early signs of hypersensitivity reactions. 
Bolnike, ki se zdravijo sami doma, in/ali njihove skrbnike morate poučiti o tem, kako spoznati zgodnje znake preobčutljivostnih reakcij.
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. 
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.
What HyQvia is and what it is used for 
Kaj je zdravilo HyQvia in za kaj ga uporabljamo
Hypersensitivity to the active substance (IgG) or to any of the excipients listed in section 6.1 (see section 4.4). 
Preobčutljivost na učinkovino (IgG) ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
• Write down the date, time, dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion. 
• Zapišite datum, uro, mesto(a) infundiranja (kar vam bo v pomoč pri menjavi mest) in morebitne reakcije po vsaki infuziji.
Do not use heating devices including microwaves. 
Ne uporabljajte grelnih naprav, vključno z mikrovalovnimi pečicami.
Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis. 
Prejemnike imunoglobulinskega zdravila morate spremljati za klinične znake in simptome hemolize.
Infections and infestations: Meningitis aseptic 
Infekcijske in parazitske bolezni: aseptični meningitis
What you need to know before you use HyQvia 
Kaj morate vedeti, preden boste uporabili zdravilo HyQvia
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. 
Ko bosta zdravnik ali medicinska sestra ugotovila pravi odmerek in hitrost infundiranja za vas, vam bosta lahko dovolila, da se začnete zdraviti sami doma.
The vial of immunoglobulins has been prepared from the blood of healthy people. 
Viala imunoglobulinov je bila pripravljena iz krvi zdravih oseb.
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. 
Zdravila se ne sme infundirati v okuženo oz. akutno vneto področje ali v njegovo bližino zaradi nevarnosti širjenja lokalizirane okužbe.
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. 
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.
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). 
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).
• 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). 
• 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).
HyQvia can be used to administer a full therapeutic dose in one to two sites up to every four weeks. 
Zdravilo HyQvia se lahko uporablja za dajanje celotnega terapevtskega odmerka na eno ali dve mesti enkrat na do štiri tedne.
The safety of IG 10% has been demonstrated in several non-clinical studies. 
Varnost IG 10 % so dokazali v več predkliničnih študijah.
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. 
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.
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. 
Natančno upoštevajte zdravnikova navodila glede odmerka, hitrosti infundiranja in urnika infundiranja zdravila HyQvia tako, da vam bo zdravljenje pomagalo.
HyQvia must not be given intravenously or intramuscularly. 
Zdravila HyQvia ne smete dajati intravensko ali intramuskularno.
You and your guardian will be trained to detect early signs of side effects, especially allergic reactions. 
Vi in vaš skrbnik se bosta usposobila za prepoznavanje zgodnjih znakov neželenih učinkov, zlati alergijskih reakcij.
The maximum IgA content is 140 micrograms/ml. 
Največja vsebnost IgA je 140 mikrogramov/ml.
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. 
V vseh drugih primerih vas bodo spremljali med infuzijo in vsaj 20 minut po prvih nekaj infuzijah zdravila HyQvia.
Interference with serological testing 
Motnje seroloških preiskav
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. 
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.
OUTER CARTON (2.5 G, 5 G, 10 G, 20 G AND 30 G) 
ZUNANJA ŠKATLA (2,5 G; 5 G; 10 G; 20 G IN 30 G)
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. 
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.
Wings of needle should lay flat on the skin. 
Metuljček igle mora plosko ležati na koži.
Recombinant human hyaluronidase is a soluble recombinant form of human hyaluronidase that increases the permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan. 
Rekombinantna humana hialuronidaza je topna rekombinantna oblika humane hialuronidaze, ki poveča permeabilnost subkutanega tkiva, tako da začasno depolimerizira hialuronan.
See image for infusion site locations. 
Glejte sliko položajev mest infundiranja.
Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected. 
Klinične izkušnje z imunoglobulini kažejo, da ni pričakovati škodljivih učinkov IG 10 % na plodnost.
Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm 
Preiskave likvorja so pogosto pozitivne s pleocitozo, ki doseže nekaj tisoč celic na mm
• Cap: Protective cap is on the dual vial unit. 
• Zaporka: Zaščitna zaporka je na enoti z dvema vialama.
No skin changes were observed that did not resolve during the clinical study. 
Niso odkrili kožnih sprememb, ki niso izzvenele med klinično študijo.
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. 
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.
The most frequently reported adverse reactions (ARs) of HyQvia were local reactions. 
Neželeni učinki zdravila HyQvia, o katerih so poročali najpogosteje, so bile lokalne reakcije.
Patients should be sufficiently hydrated before use of immunoglobulins. 
Pred uporabo imunoglobulinov morajo biti bolniki zadostno hidrirani.
• Avoid bony areas, visible blood vessels, scars and any areas of inflammation or infection. 
• Izognite se koščenim področjem, vidnim žilam, brazgotinam in vsem vnetim ali okuženim področjem.
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. 
Študije toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja niso izvedljive zaradi indukcije razvoja protiteles proti heterolognim beljakovinam in njihove interference.
If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable. 
Če bolnik izpusti odmerek, mu izpuščeni odmerek aplicirajte čim prej, nato pa nadaljujte z načrtovanim razporedom zdravljenja.
The pharmacokinetic results are presented in the table below, as compared to data for intravenous administration of IG 10% obtained in the same study. 
Rezultati farmakokinetike so predstavljeni v spodnji preglednici skupaj s podatki za intravensko dajanje IG 10 %, ki so bili dobljeni v isti študiji.
The recommended infusion rate given in section 4.2 should be adhered to. 
Upoštevati morate priporočeno hitrost infundiranja, ki je navedena v poglavju 4.2.
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. 
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.
• If more than one vial is required for a full dose, spike subsequent vials after the first vial has been fully administered. 
• Če za celoten odmerek potrebujete več kot eno vialo, predrite naslednje viale, ko končate z dajanjem prve viale.
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. 
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 %.
A-1221 Vienna 
A-1221 Dunaj
Do not infuse a double dose of HyQvia to make up for a missed dose. 
Ne infundirajte dvojnega odmerka zdravila HyQvia, če ste pozabili vzeti prejšnji odmerek.
Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. 
Preobčutljivost na humane imunoglobuline, zlasti v zelo redkih primerih pomanjkljivosti IgA, ko ima bolnik razvita protitelesa proti IgA.
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. 
Če bolnik prenaša začetne infuzije celotnega odmerka na mesto in pri največji hitrosti, se hitrost naslednjih infuzij po presoji zdravnika in bolnika lahko poveča.
• Repeat Step 6, if more than one vial of recombinant human hyaluronidase is needed for your dose. 
• Ponovite 6. korak, če za vaš odmerek potrebujete več kot eno vialo rekombinantne humane hialuronidaze.
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. 
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.
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. 
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.
Doctors are aware of these possible side effects and will monitor you during and after the initial infusions. 
Zdravniki se zavedajo teh možnih neželenih učinkov, zato vas bodo spremljali tekom prvih infuzij in po njih.
Sometimes your doctor may recommend that larger doses are split and given at two sites at once. 
Morda vam bo zdravnik priporočil razdelitev večjega odmerka, tako da se ga da sočasno na dve mesti.