natgillin/translations-raw huggingface dataset:
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.
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).
• Sodium (as chloride and as phosphate) The total sodium content of recombinant human hyaluronidase is 4.03 mg/ml.
• Natrij (v obliki natrijevega klorida in natrijevega fosfata) Skupna vsebnost natrija v rekombinantni humani hialuronidazi je 4,03 mg/ml.
Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg.
Rekombinantna humana hialuronidaza vsebuje 4,03 mg natrija na ml, največji dnevni odmerek pa je približno 120 mg.
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.
Klinične izkušnje z imunoglobulini kažejo, da ni pričakovati neugodnih učinkov na potek nosečnosti ali na plod ali novorojenčka.
Subjects ≥ 40 kg
Bolniki ≥40 kg
These antibodies were not capable of neutralizing recombinant human hyaluronidase.
Ta protitelesa niso bila zmožna nevtralizacije rekombinantne humane hialuronidaze.
If you think that you used more HyQvia than you should, speak to your doctor as soon as possible.
Če menite, da ste uporabili večji odmerek zdravila HyQvia, kot bi smeli, se čimprej posvetujte s svojim zdravnikom.
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.
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.
Pharmacotherapeutic group (human normal immunoglobulin): immune sera and immunoglobulins: immunoglobulins, normal human, ATC code: J06BA01
Farmakoterapevtska skupina (humani polispecifični imunoglobulin): imunski serumi in imunoglobulini: imunoglobulini humanega izvora, oznaka ATC: J06BA01
Solution for infusion (infusion).
Raztopina za infundiranje (infuzijo).
If you use more HyQvia than you should
Če ste uporabili večji odmerek zdravila HyQvia, kot bi smeli
The recommended starting dose is one that supplies 400 to 800 mg of active substance per kg of bodyweight per month.
Priporočeni začetni odmerek je takšen, da zagotovi od 400 do 800 mg učinkovine na kg telesne mase na mesec.
The following ADRs are not listed but also calculated in the frequency for Local reactions: feeling hot, infusion site paresthesia.
Naslednji neželeni učinki niso navedeni, a so upoštevani pri pogostnosti lokalnih reakcij: občutek vročine, parestezija na mestu infundiranja.
Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Humani polispecifični imunoglobulin vsebuje protitelesa IgG, ki so prisotna v normalni populaciji.
You may experience a sudden fall in blood pressure and, in isolated cases, anaphylactic shock.
Lahko se pojavi nenaden padec krvnega tlaka in v posameznih primerih, anafilaktični šok.
Patients may experience side effects (for example dizziness or nausea) during treatment with HyQvia that might affect the ability to drive and use machines.
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.
The syringe tip will be pointing upward.
Konica brizge bo obrnjena gor.
HyQvia Median (95% Cl) N=60
HyQvia Mediana (95-odstotni IZ) N=60
• 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.
• 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.
Posology The dose and dose regimen are dependent on the indication.
Odmerjanje Odmerek in shema odmerjanja sta odvisna od indikacije.
Secure the needle to the skin:
Injekcijsko iglo pritrdite na kožo:
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.
Na začetku bosta zdravnik ali medicinska sestra uporabila majhno hitrost infundiranja, nato pa jo bosta postopno povečevala med prvim in naslednjimi infundiranji.
The first infusion of HyQvia should be given one week after the last treatment with the previous immunoglobulin.
Prvo infundiranje zdravila HyQvia opravite en teden po dajanju prejšnjega imunoglobulina.
Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester.
Dokazali so, da zdravila z imunoglobulini prehajajo placento, kar se še stopnjuje v tretjem trimestru.
Hyaluronan is a polysaccharide found in the intercellular matrix of the connective tissue.
Hialuronan je polisaharid, ki ga najdemo v medceličnem matriksu vezivnega tkiva.
Subjects < 40 kg
Bolniki <40 kg
• Colour: o The recombinant human hyaluronidase should be clear and colourless.
• Barva:  Raztopina rekombinantne humane hialuronidaze mora biti bistra in brezbarvna.
Very common side effects (may affect more than 1 in 10 infusions):
Pogosti neželeni učinki (pojavijo se lahko pri več največ 1 od 10 infuzij):
Home treatment Before you start home treatment you should assign a person as guardian.
Zdravljenje doma Pred začetkom zdravljenja doma morate določiti skrbnika.
No temporal association between adverse reactions and the presence of anti-rHuPH20 antibodies could be demonstrated.
Časovne povezave med neželenimi učinki in prisotnostjo protiteles proti rHuPH20 niso dokazali.
First Two Infusions (ml/hour/infusion site)
Prvi dve infuziji (ml/uro/mesto infundiranja)
Therefore, after receiving HyQvia, you may have to wait for up to 3 months before receiving certain vaccines.
Zato morate po prejemanju zdravila HyQvia počakati do 3 mesece, preden prejmete določena cepiva.
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.
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.
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of opsonising and neutralizing antibodies against infectious agents.
Humani polispecifični imunoglobulin vsebuje predvsem imunoglobulin G (IgG) s široko paleto opsonizirajočih in nevtralizirajočih protiteles proti povzročiteljem nalezljivih bolezni.
• If known anaphylactic or severe hypersensitivity to human immunoglobulin exists, it should be noted in the patient records.
• Dokazano anafilaksijo ali hudo preobčutljivost na humane imunoglobuline je treba zabeležiti v bolnikovo kartoteko.
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).
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).
This also applies to unknown or emerging viruses and other pathogens.
To se nanaša tudi na doslej še neznane ali porajajoče se viruse in druge povzročitelje bolezni.
• patients with an inborn inability or reduced ability to produce antibodies (primary immunodeficiencies).
• bolniki s prirojeno nezmožnostjo ali zmanjšano zmožnostjo tvorbe protiteles (primarno imunsko pomanjkljivostjo),
Do not mix the two vials prior to administration.
Obeh vial pred uporabo ne zmešajte.
Only two instances of local adverse reactions were severe, infusion site pain and infusion site swelling.
Samo dva primera lokalnih neželenih učinkov sta bila huda, bolečina na mestu infundiranja in oteklina na mestu infundiranja.
• Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
• katerem od sindromov primarne imunske pomanjkljivosti z okvarjeno tvorbo protiteles (glejte poglavje 4.4),
Immunoglobulins are also known as antibodies and are found in healthy people's blood.
Imunoglobuline imenujemo tudi protitelesa in so prisotna v krvi zdravih oseb.
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.
Aplicirati morate celotno vsebino viale z rekombinantno humano hialuronidazo, ne glede na to, ali aplicirate tudi celotno vsebino viale z IG 10 %.
Do not use this medicine if the solutions are cloudy or have particles or deposits.
Ne uporabljajte tega zdravila, če opazite, da sta raztopini motni ali vsebujeta delce ali usedlino.
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).
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).
You may be allergic to immunoglobulins without knowing it. Allergic reactions such as sudden fall in blood pressure or anaphylactic shock (a sharp fall in blood pressure with other symptoms such as swelling of the throat, breathing difficulties and skin rash) are rare but they can occasionally occur even if you have not previously had problems with similar treatments.
Alergijske reakcije, kot so nenaden padec krvnega tlaka ali anafilaktični šok (nenaden padec krvnega tlaka z drugimi simptomi, kot so otekanje žrela, oteženo dihanje in kožni izpuščaj), so redke, vendar do njih lahko pride tudi, če prej niste imeli težav s podobnim zdravljenjem.
Each vial of IG 10% is supplied with the appropriate corresponding quantity of recombinant human hyaluronidase as stated in the table below.
Vsaka viala IG 10 % je na voljo z ustrezno količino rekombinantne humane hialuronidaze, kot je navedeno v spodnji preglednici.
Do not inject or infuse HyQvia
Ne injicirajte ali infundirajte zdravila HyQvia:
The effects of antibodies to the recombinant human hyaluronidase component of HyQvia on the human embryo or on human foetal development are currently unknown (see section 5.3).
Učinki protiteles proti komponenti z rekombinantno hialuronidazo zdravila HyQvia na človeški zarodek ali razvoj človeškega plodu trenutno še niso znani (glejte poglavje 5.3).
These antibodies bind to red blood cells (RBC) epitops (which may be detected as a positive direct antiglobulin test [DAT, (Coombs' test)] and, rarely, may cause haemolysis.
Ta protitelesa se vežejo na epitope eritrocitov (kar lahko zaznamo kot pozitivni neposredni protiglobulinski test [direct antiglobulin test, DAT (Coombsov test)]) in v redkih primerih lahko povzročajo hemolizo.
Immunoglobulins are normal constituents of the human body.
Imunoglobulini so normalne sestavine v človeškem telesu.
The dosage interval to maintain steady state levels varies from 2-4 weeks.
Presledek med odmerki za ohranjanje koncentracije v stanju dinamičnega ravnovesja je od 2 do 4 tedne.
• Official batch release
• Uradna sprostitev serije:
Patients previously treated with immunoglobulin administered subcutaneously For patients currently being administered immunoglobulin subcutaneously, the initial dose of HyQvia is the same as for subcutaneous treatment, but may be adjusted to 3- or 4-weeks interval.
Bolniki, ki so bili predhodno zdravljeni z imunoglobulini, uporabljenimi subkutano Pri bolnikih, ki trenutno prejemajo imunoglobuline subkutano, je začetni odmerek zdravila HyQvia enak kot za subkutano zdravljenje, vendar se lahko prilagodi na tri-ali štiritedenski presledek.
HyQvia contains two solutions for infusion (drip) under the skin (subcutaneous or SC infusion).
Zdravilo HyQvia vsebuje dve raztopini za infundiranje (kapalno infuzijo) pod kožo (subkutana ali s.c. infuzija).
At the initiation of therapy, it is recommended that the treatment intervals for the first infusions be gradually prolonged from a 1-week dose to up to a 3- or 4-week dose.
Priporočljivo je, da ob začetku zdravljenja presledke med prvimi infundiranji postopno podaljšujete od enotedenskega odmerka do tri-ali štiritedenskega odmerka.
If you think that you have missed a dose speak to your doctor as soon as possible.
Če menite, da ste pozabili odmerek, se čimprej posvetujte s svojim zdravnikom.
The cumulative monthly dose of IG 10% should be divided into 1-week, 2-week etc. doses according to the planned treatment intervals with HyQvia.
Kumulativni mesečni odmerek IG 10 % razdelite v enotedenske, dvotedenske itn. odmerke po načrtovanih presledkih med odmerki zdravila HyQvia.
Any suspicion of allergic or anaphylactic like reactions following recombinant human hyaluronidase administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary.
Pri sumu na alergijsko ali anafilaktično reakcijo po infundiranju rekombinantne humane hialuronidaze je potrebna takojšnja ustavitev infundiranja in po potrebi uvedba standardnega medicinskega zdravljenja.
How HyQvia works
Kako zdravilo HyQvia deluje
Human normal immunoglobulin (SCIg)
Humani polispecifični imunoglobulin (SCIg)
Human normal immunoglobulin 10% belongs to a class of medicines called “human normal immunoglobulins”.
Humani polispecifični imunoglobulin 10 % spada v skupino zdravil, ki jim pravimo ”humani polispecifični imunoglobulini”.
Marketing Authorisation Holder: Baxalta Innovations GmbH Industriestrasse 67
Imetnik dovoljenja za promet: Baxalta Innovations GmbH Industriestrasse 67
The two components of the medicinal product must be administered sequentially through the same needle beginning with the recombinant human hyaluronidase followed by IG 10%, as described below.
Obe komponenti zdravila je treba dati zaporedno skozi isto iglo: najprej rekombinantno humano hialuronidazo, nato pa še IG 10 %, kakor je opisano v nadaljevanju.
After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Po dajanju tega zdravila morajo preteči 3 meseci, preden lahko bolnika cepite z živimi oslabljenimi virusnimi cepivi.
Patients should be informed about first symptoms of thromboembolic events including shortness of breath, pain and swelling of a limb, focal neurological deficits and chest pain and should be advised to contact their physician immediately upon onset of symptoms.
Bolnike je treba poučiti o prvih simptomih tromboemboličnih dogodkov, vključno z zasoplostjo, bolečinami v okončinah in otekanjem okončin, žariščnimi nevrološkimi deficiti in bolečinami v prsnem košu, ter jim naročiti, da se ob pojavu simptomov nemudoma posvetujejo s svojim zdravnikom.
The recombinant human hyaluronidase of HyQvia acts locally.
Rekombinantna humana hialuronidaza v zdravilu HyQvia deluje lokalno.
HyQvia may reduce the effect of some virus vaccines such as measles, rubella, mumps and chicken pox (live virus vaccines).
Zdravilo HyQvia lahko zmanjša učinkovitost nekaterih virusnih cepiv, kot so cepiva proti ošpicam, rdečkam, mumpsu in noricam (živa virusna cepiva).
• Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.
• hipogamaglobulinemiji in ponavljajočih se bakterijskih okužbah pri bolnikih s kronično limfocitno levkemijo (KLL), pri katerih je bilo profilaktično zdravljenje z antibiotiki neuspešno ali je kontraindicirano,
In case of shock, immediately discontinue the infusion and treat the patient for shock.
V primeru šoka je treba takoj prekiniti infundiranje in začeti standardno zdravljenje za šok.
In case subcutaneous infusion of HyQvia is used for home treatment, therapy should be initiated and monitored by a physician experienced in the guidance of patients for home treatment.
Subkutano infundiranje zdravila HyQvia pri zdravljenju doma naj uvede in spremlja zdravnik z izkušnjami v vodenju bolnikov pri zdravljenju na domu.
Adequate doses of human normal immunoglobulin may restore abnormally low IgG levels to the normal range.
Z ustreznimi odmerki polispecifičnega imunoglobulina lahko obnovimo nenormalno nizko koncentracijo IgG do normalnega razpona.
From post-marketing data no clear correlation of AMS to higher doses was observed.
Podatki iz obdobja trženja ne kažejo jasne povezave AMS z velikimi odmerki.
Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Imunoglobulini se izločajo v materino mleko in lahko prispevajo k zaščiti novorojenčka pred patogeni, ki vstopajo prek sluznic.
The IG 10% component contains trace amounts of sodium.
Komponenta IG 10 % vsebuje natrij v sledovih.
Subsequent 2 to 3 Infusions (ml/hour/infusion site)
Naslednje 2−3 infuzije (ml/uro/mesto infundiranja)
However, needles with smaller diameters may be used if slower flow rates are acceptable.
Če je sprejemljiva manjša hitrost infundiranja, se lahko uporabijo igle z manjšimi premeri.
Sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid disodium, calcium chloride, water for injections.
Natrijev klorid, natrijev fosfat, humani albumin, dinatrijev etilendiamintetraacetat, kalcijev klorid, voda za injekcije.
Acute renal failure
Akutna ledvična odpoved
The following dosage regimens are given as a guideline.
V nadaljevanju so navedene priporočene sheme odmerjanja.
Nearly all of the subjects were able to attain the same dose interval with HyQvia as they had for intravenous administration.
Pri skoraj vseh preiskovancih je bilo možno doseči enak presledek odmerjanja zdravila HyQvia kot pri intravenskem dajanju.
The patient will be instructed in infusion techniques, the use of an infusion pump or syringe driver, the keeping of a treatment diary, recognition of possible severe adverse reactions and measures to be taken in case these occur.
Bolnika je treba poučiti o tehnikah infundiranja, uporabi infuzijske črpalke ali pripomočka, vodenju dnevnika zdravljenja, prepoznavanju morebitnih hudih neželenih učinkov in ukrepih ob pojavu teh učinkov.
Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Nadomestno zdravljenje mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem imunskih pomanjkljivosti.
• Throw away any unused product in the vial and the disposable supplies as recommended by your healthcare professional.
• Neuporabljeno zdravilo v viali ter pripomočke za enkratno uporabo zavrzite po navodilu zdravstvenega delavca.
Human normal immunoglobulin (IG 10%) vial 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl rubber).
Viala humanega polispecifičnega imunoglobulina (IG 10 %) 25, 50, 100, 200 ali 300 ml raztopine v viali (iz stekla tipa I) z zamaškom (iz bromobutilne gume).
Do not infuse HyQvia into or around an infected or red swollen area on your skin because it may cause the infection to spread.
Zdravila HyQvia ne infundirajte v okuženo oz. rdeče, oteklo področje kože ali v njegovo bližino zaradi nevarnosti širjenja okužbe.
Trough levels should be measured and assessed in conjunction with the incidence of infection.
Meriti morate najnižje koncentracije zdravila v krvi in jih vrednotiti skupaj s pojavnostjo okužb.
Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma.
Humani polispecifični imunoglobulin in humani serumski albumin (stabilizator rekombinantne humane hialuronidaze) sta pripravljena iz človeške plazme.
• If using a pump, prepare the pump to infuse the recombinant human hyaluronidase at an initial rate per infusion site of 60 to 120 ml/hour and increase as tolerated.
• Če uporabljate črpalko, jo pripravite tako, da infundira rekombinantno humano hialuronidazo z začetno hitrostjo na mesto infundiranja približno 60 do 120 ml/uro, ki jo povečujte, kolikor jo lahko prenašate.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Kadar se zdravila pripravljajo iz človeške krvi ali plazme, se z določenimi postopki preprečuje prenos okužb na bolnike.
You will be instructed in: - Germ-free (aseptic) infusion techniques, - The use of an infusion pump or syringe driver (if needed), - Keeping a treatment diary, and - Measures to be taken in case of severe side effects.
Poučili vas bodo o: - (aseptičnih) tehnikah infundiranja, ki preprečujejo vdor bolezenskim povzročiteljem, - uporabi infuzijske črpalke ali pripomočka za injiciranje (če sta potrebna), - vodenju dnevnika zdravljenja in - ukrepih v primeru, da nastopijo hudi neželeni učinki.
• Hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (HSCT).
• hipogamaglobulinemiji pri bolnikih pred alogensko presaditvijo krvotvornih matičnih celic (HSCT) in po njej.
Administer the human normal immunoglobulin 10%: After infusing all of the content of the smaller syringe (recombinant human hyaluronidase), remove the syringe from the hub of the needle set.
Infundirajte humani polispecifični imunoglobulin 10 %: Po infuziji celotne vsebine manjše brizge (rekombinantne humane hialuronidaze), izvlecite brizgo iz priključka kompleta injekcijske igle.
• Remove the peel-off label from HyQvia vial, which has the product lot number and expiration date, and place the label in your treatment record/log book.
• Odlepite nalepko z viale zdravila HyQvia, na kateri je navedena serija zdravila in datum izteka roka uporabnosti, ter jo nalepite v dnevnik zdravljenja.
• Patients should be informed of the early signs of anaphylaxis/hypersensitivity (hives, pruritus, generalized urticaria, tightness of the chest, wheezing, and hypotension).
• Bolnike morate poučiti o zgodnjih znakih anafilaksije/preobčutljivosti (koprivnica, srbenje, generalizirana urtikarija, tiščanje v prsih, sopenje in hipotenzija).
► If you experience any side effects, you or your guardian must stop the infusion immediately and contact a doctor.
► Če se neželeni učinki pojavijo, morate vi ali vaš skrbnik nemudoma prekiniti infundiranje in poklicati zdravnika.
Pack size: One vial of IG 10% and one vial of recombinant human hyaluronidase in a dual vial unit.
Velikost pakiranja: Ena viala IG 10 % in ena viala rekombinantne humane hialuronidaze v enoti z dvema vialama.
In the clinical study with HyQvia, no differences in the plasma IgG trough levels were observed between adult and paediatric patients.
V klinični študiji zdravila HyQvia niso ugotovili razlik v najnižjih plazemskih koncentracijah IgG med pediatričnimi bolniki in odraslimi bolniki.
• patients with low antibody production prior and after transplantation of bone marrow cells from another person.
• bolniki z nizko tvorbo protiteles pred presaditvijo celic kostnega mozga druge osebe in po presaditvi.
Despite these measures, when medicines prepared from human blood or plasma are used, the possibility of passing on infection cannot be totally excluded.
Kljub tem ukrepom pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti prenosa okužbe.