FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Za bočicu rekombinantne ljudske hijaluronidaze od 1,25 ml upotrijebite iglu od 18-22 G da izvučete sadržaj bočice kako biste spriječili uguravanje ili drobljenje čepa; za sve ostale veličine bočica, igla ili naprava bez igle mogu se upotrijebiti za izvlačenje sadržaja bočice.
English: Trough levels should be measured and assessed in conjunction with the incidence of infection.
Croatian: Najnižu koncentraciju treba mjeriti i procijeniti u odnosu na incidenciju infekcija.
English: The most frequently reported adverse reactions (ARs) of HyQvia were local reactions.
Croatian: Najčešće prijavljivane nuspojave lijeka HyQvia bile su lokalne reakcije.
English: For instructions on how to use the medicinal product, see section 6.6.
Croatian: Za upute o primjeni lijeka vidjeti dio 6.6.
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.
Croatian: Nakon davanja infuzije imunoglobulina privremeni porast različitih pasivno prenesenih protutijela u krvi bolesnika može rezultirati lažno pozitivnim rezultatima seroloških pretraga.
English: Immunoglobulins are also known as antibodies and are found in healthy people's blood.
Croatian: Imunoglobulini su poznati također kao protutijela i mogu se naći u krvi zdravih osoba.
English: Hypersensitivity to IG 10%
Croatian: Preosjetljivost na IG 10%
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.
Croatian: Preporučuje se da se sastojak rekombinantne ljudske hijaluronidaze primijeni konstantnom brzinom i da se brzina primjene IG-a 10% ne povećava iznad preporučenih brzina, posebno kada je bolesnik tek počeo terapiju lijekom HyQvia.
English: Home treatment Before you start home treatment you should assign a person as guardian.
Croatian: Kućno liječenje Prije nego započnete liječenje kod kuće, morate odabrati osobu koja će biti staratelj.
English: The recombinant human hyaluronidase facilitates the dispersion and absorption of IG 10%.
Croatian: Rekombinantna ljudska hijaluronidaza olakšava disperziju i apsorpciju IG-a 10%.
English: The maximum IgA content is 140 micrograms/ml.
Croatian: Maksimalni sadržaj IgA iznosi 140 mikrograma/ml.
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.
Croatian: Preporučuje se da svaki put kada primjenjujete lijek HyQvia zabilježite u Vaš dnevnik terapije sljedeće podatke: - datum primjene - serijski broj lijeka - količinu i brzinu infuzije, broj i položaj(e) mjesta primjene infuzije.
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.
Croatian: Vašu terapiju će započeti liječnik ili medicinska sestra s iskustvom u liječenju bolesnika sa slabim imunološkim sustavom i u savjetovanju bolesnika za kućno liječenje.
English: • Insert needle completely to the wings of the needle with a rapid motion straight into the skin at a 90-degree angle.
Croatian: • Potpuno uvedite iglu do jezičaca igle brzim pokretom ravno u kožu pod kutom od 90 stupnjeva.
English: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and - the testing of each donation and pools of plasma for signs of viruses/infections.
Croatian: - pažljiv odabir donatora krvi i plazme kako bi se sa sigurnošću isključile osobe kod kojih postoji rizik da su nositelji infekcija i - ispitivanje svake donacije i ukupne sakupljene plazme radi otkrivanja znakova virusa/infekcija.
English: However, antibodies to hyaluronidase did not influence reproduction following immunization of mice, rabbits, sheep, or cynomolgus monkeys.
Croatian: Međutim, protutijela na hijaluronidazu nisu utjecala na reprodukciju nakon imunizacije u miševa, kunića, ovaca ili makaki majmuna.
English: • patients with an inborn inability or reduced ability to produce antibodies (primary immunodeficiencies).
Croatian: • bolesnici s urođenom nesposobnošću ili smanjenom sposobnošću stvaranja protutijela (primarne imunodeficijencije)
English: Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg.
Croatian: Rekombinantna ljudska hijaluronidaza sadrži 4,03 mg natrija po ml, s maksimalnom dnevnom dozom od približno 120 mg.
English: Push the air into the vial.
Croatian: Utisnite zrak u bočicu.
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
Croatian: Svaka bočica od 25 ml sadrži: 2,5 g normalnog ljudskog imunoglobulina Svaka bočica od 50 ml sadrži: 5 g normalnog ljudskog imunoglobulina Svaka bočica od 100 ml sadrži: 10 g normalnog ljudskog imunoglobulina Svaka bočica od 200 ml sadrži: 20 g normalnog ljudskog imunoglobulina Svaka bočica od 300 ml sadrži: 30 g normalnog ljudskog imunoglobulina
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.
Croatian: Bila su dva slučaja reverzibilnog genitalnog edema; jedan se smatrao teškim, a nastao je zbog difuzije lijeka iz mjesta primjene infuzije u abdomen.
English: You will be watched carefully throughout the infusion and for at least 1 hour after stopping the infusion to see how well you tolerate the medicine.
Croatian: Bit ćete pažljivo nadzirani tijekom cijelog trajanja infuzije i najmanje 1 sat nakon prekida infuzije kako bi se vidjelo koliko dobro podnosite lijek.
English: If a woman becomes pregnant, the treating physician should encourage her to participate in the pregnancy registry.
Croatian: Ako žena zatrudni, nadležni liječnik treba je potaknuti na uključivanje u registar trudnoća.
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of opsonising and neutralizing antibodies against infectious agents.
Croatian: Normalni ljudski imunoglobulin sadrži uglavnom imunoglobulin G (IgG) sa širokim spektrom opsonizirajućih i neutralizirajućih protutijela protiv infektivnih uzročnika.
English: Solution for infusion (infusion).
Croatian: Otopina za infuziju (infuzija).
English: Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Croatian: Praćenje znakova i simptoma tromboze i ocjena viskoznosti krvi u bolesnika s rizikom od hiperviskoznosti.
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Croatian: Bolesnici koji osjete nuspojave tijekom liječenja trebaju pričekati da one nestanu prije upravljanja vozilima ili rada sa strojevima.
English: The following infusion rates of the IG 10% are recommended per infusion site:
Croatian: Preporučuju se sljedeće brzine infuzije IG-a 10% po mjestu primjene infuzije:
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.
Croatian: Na početku će Vaš liječnik ili medicinska sestra infuziju primijeniti sporo, zatim će je postupno ubrzati tijekom prve infuzije i prilikom sljedećih infuzija.
English: Subjects < 40 kg
Croatian: Osobe < 40 kg
English: Treatment with HyQvia will be started by your doctor or nurse, but you may be allowed to use the medicine at home once you have received the first few infusions under medical supervision and you (and/or your guardian) have been adequately trained.
Croatian: Terapiju lijekom HyQvia započet će Vaš liječnik ili medicinska sestra, ali ćete vjerojatno Vi moći nastaviti primjenu lijeka kod kuće nakon što primite nekoliko prvih infuzija pod medicinskim nadzorom i nakon što Vi (i/ili Vaš staratelj) dobijete prikladne upute kako to činiti.
English: Place all gathered supplies and open them as directed by your healthcare professional.
Croatian: Uzmite sav prikupljen materijal i otvorite ga prema uputama Vašeg zdravstvenog radnika.
English: The recommended starting dose is one that supplies 400 to 800 mg of active substance per kg of bodyweight per month.
Croatian: Preporučena početna doza je ona koja isporučuje od 400 do 800 mg djelatne tvari po kg tjelesne težine mjesečno.
English: 90-degree angle to skin
Croatian: U kožu pod kutom od 90 stupnjeva
English: Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Croatian: Nadomjesnu terapiju treba započeti i provoditi pod nadzorom liječnika iskusnog u liječenju imunodeficijencije.
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.
Croatian: Bolesnici s protutijelima na IgA, u kojih liječenje supkutanim lijekovima s IgG ostaje jedina opcija, smiju se liječiti lijekom HyQvia samo uz poman liječnički nadzor.
English: Passive transmission of antibodies to erythrocyte´s surface antigens, (e.g., A, B, D) may interfere with some serological tests for red cell antibodies for example the direct antiglobulin test (DAT, direct Coombs' test).
Croatian: Pasivni prijenos protutijela na antigene površine eritrocita (npr. A, B, D) može interferirati s nekim serološkim pretragama za protutijela na crvene krvne stanice, primjerice direktni antiglobulinski test (DAT, direktni Coombsov test).
English: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
Croatian: • kod sindroma primarnih imunodeficijencija s nedovoljnom proizvodnjom antitijela (vidjeti dio 4.4),
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.
Croatian: Za takva protutijela postoji potencijal križne reakcije s endogenim PH20, za koji je poznato da se eksprimira u testisima, epididimisu i spremi odraslih muškaraca.
English: Regular and sufficient doses of HyQvia can raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy).
Croatian: Redovite i dovoljne doze lijeka HyQvia mogu povisiti abnormalno niske razine imunoglobulina u Vašoj krvi do normalnih razina (nadomjesna terapija).
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.
Croatian: Lokalne reakcije opažene tijekom pivotalnih kliničkih ispitivanja uključuju blago oticanje mjesta (prisutno u većini infuzija) zbog primjene velikih količina infuzije, ali se općenito nisu smatrale nuspojavama osim kada bi izazvale nelagodu.
English: Wings of needle should lay flat on the skin.
Croatian: Jezičci igle moraju biti položeni na kožu.
English: • The medicinal product is for subcutaneous use only, do not administer intravenously.
Croatian: • Ovaj lijek je namijenjen samo za supkutanu primjenu, ne smije se primijeniti intravenski.
English: • Avoid bony areas, visible blood vessels, scars and any areas of inflammation or infection.
Croatian: • Izbjegavajte koštana područja, vidljive krvne žile, ožiljke i sva upaljena ili zaražena područja.
English: He or she will decide whether to slow down the infusion rate or stop the infusion completely.
Croatian: On ili ona će odlučiti treba li usporiti ili prekinuti infuziju.
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.
Croatian: Bolesnici mogu imati nuspojave (na primjer omaglicu ili mučninu) tijekom terapije lijekom HyQvia, koje mogu imati utjecaj na sposobnost upravljanja vozilima i rada na strojevima.
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.
Croatian: 66 bolesnika koji su dovršili pivotalno ispitivanje faze 3 sudjelovalo je u nastavku ispitivanja (160902) radi procjene dugoročne sigurnosti, podnošljivosti i djelotvornosti lijeka HyQvia u primarnoj imunodeficijenciji.
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.
Croatian: Protutijela protiv rekombinantne ljudske hijaluronidaze Ukupno 13 od 83 ispitanika koji su sudjelovali u osnovnom ispitivanju razvilo je protutijelo sposobno vezati se na rekombinantnu ljudsku hijaluronidazu (rHuPH20) najmanje jedanput tijekom kliničkog ispitivanja.
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).
Croatian: • Infuzija normalnog ljudskog imunoglobulina 10% HyQvia može se dati na jedan od sljedeća dva načina: ο sakupljanjem iz bočica u veću štrcaljku (a) ili infuzijsku vrećicu (b) prema uputama Vašeg zdravstvenog radnika, ovisno o pumpi koju ćete koristiti; ili ο neposredno iz bočice IG-a (c).
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”).
Croatian: Vaš liječnik ili medicinska sestra savjetovat će Vas koja je prikladna brzina infuzije kojom ćete si davati infuziju lijeka HyQvia kod kuće (pogledajte dio 3, ”Kako primjenjivati lijek HyQvia”).
English: Pharmacotherapeutic group (human normal immunoglobulin): immune sera and immunoglobulins: immunoglobulins, normal human, ATC code: J06BA01
Croatian: Farmakoterapijska skupina (normalni ljudski imunoglobulin): imunoserumi i imunoglobulini: imunoglobulini, normalni ljudski, ATK oznaka: J06BA01
English: 35.7 (32.4 to 40.4)
Croatian: 35,7 (32,4 do 40,4)
English: Use aseptic technique when preparing and administering HyQvia.
Croatian: Koristite se aseptičkom tehnikom prilikom pripreme i primjene lijeka HyQvia.
English: The effects of long-term use of recombinant human hyaluronidase on pregnancy, breast-feeding and fertility are currently not known.
Croatian: Učinci dugoročne primjene rekombinantne ljudske hijaluronidaze na trudnoću, dojenje i plodnost trenutno nisu poznati.
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.
Croatian: • Rekombinantna ljudska hijaluronidaza (rHuPH20) Rekombinantna ljudska hijaluronidaza je pročišćeni glikoprotein koji sadrži 447 aminokiselina, a proizvedena je tehnologijom rekombinantne DNK na stanicama ovarija kineskog hrčka (CHO).
English: HyQvia contains two solutions for infusion (drip) under the skin (subcutaneous or SC infusion).
Croatian: HyQvia sadrži dvije otopine za infuziju (drip) pod kožu (supkutana ili s.c. infuzija).
English: Home treatment
Croatian: Kućno liječenje
English: Patients on self-home treatment and/or their guardian should also be trained to detect early signs of hypersensitivity reactions.
Croatian: Bolesnici koji se liječe kod kuće i/ili njihovi staratelji moraju također biti upoznati s ranim znakovima reakcija preosjetljivosti.
English: If you think that you used more HyQvia than you should, speak to your doctor as soon as possible.
Croatian: Ako mislite da ste primijenili više lijeka HyQvia nego što ste trebali, što prije obavijestite svog liječnika.
English: These antibodies were not capable of neutralizing recombinant human hyaluronidase.
Croatian: Ta protutijela nisu bila sposobna neutralizirati rekombinantnu ljudsku hijaluronidazu.
English: • When using HyQvia at home, you must perform the infusion in the presence of an assigned guardian person who will help you watch out for allergic reactions, stop the infusion, and get help if necessary.
Croatian: • Prilikom primjene lijeka HyQvia kod kuće morate primijeniti infuziju uz nazočnost odabranog staratelja koji će Vam pomoći pripaziti na alergijske reakcije, zaustaviti infuziju i zatražiti pomoć ako bude potrebno.
English: The other ingredients of this vial are glycine and water for injections.
Croatian: Drugi sastojci ove bočice su glicin i voda za injekcije.
English: All other patients should be observed for at least 20 minutes after the administration.
Croatian: Sve ostale bolesnike potrebno je nadzirati još barem 20 minuta nakon završetka infuzije.
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.
Croatian: Ukupna stopa infekcija bila je niža tijekom primjene lijeka HyQvia nego tijekom tromjesečne intravenske primjene IG-a 10%: procjena jednim brojem anualizirane stope svih infekcija bila je 2,97 (95%-tni CI: od 2,51 do 3,47) za lijek HyQvia i 4,51 (95%-tni CI: od 3,50 do 5,69) za intravenske infuzije IG-a 10%.
English: • Repeat Step 6, if more than one vial of recombinant human hyaluronidase is needed for your dose.
Croatian: • Ponovite korak br. 6 ako je za Vašu dozu potrebna više od jedne bočice rekombinantne ljudske hijaluronidaze.
English: Human normal immunoglobulin 10% belongs to a class of medicines called “human normal immunoglobulins”.
Croatian: Normalni ljudski imunoglobulin 10% pripada skupini lijekova zvanih ”normalni ljudski imunoglobulini”.
English: Efficacy and safety of HyQvia was assessed in a phase 3 study (160603) in 83 patients with PID.
Croatian: Djelotvornost i sigurnost lijeka HyQvia procijenjene su u ispitivanja faze 3 (160603) u 83 bolesnika s primarnom imunodeficijencijom.
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.
Croatian: Prijavljena je pojava sindroma aseptičkog meningitisa povezanog s intravenskom i supkutanom imunoglobulinskom terapijom; simptomi obično počinju unutar nekoliko sati pa do 2 dana nakon terapije imunoglobulinom.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi na sve nepoznate ili nove viruse, kao i na ostale patogene.
English: A-1221 Vienna
Croatian: A-1221 Beč
English: Do not inject or infuse HyQvia
Croatian: Nemojte ubrizgati ili primiti infuziju lijeka HyQvia
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.
Croatian: Standardne mjere prevencije infekcija uzrokovanih korištenjem lijekova pripremljenih od ljudske krvi ili plazme uključuju odabir davatelja, probir pojedinačnih donacija i sakupljenih pulova plazme za određene pokazatelje infekcije i uključivanje koraka učinkovite proizvodnje za inaktivaciju/uklanjanje virusa.
English: Development and reproductive toxicology studies have been conducted with recombinant human hyaluronidase in mice and rabbits.
Croatian: Ispitivanja razvojne i reproduktivne toksičnosti provedena su s rekombinantnom ljudskom hijaluronidazom u miševa i kunića.
English: Haemolytic anaemia
Croatian: Hemolitička anemija
English: Pharmacokinetic Parameters of HyQvia Compared to Intravenous Administration of IG 10% Parameter
Croatian: Farmakokinetički parametri lijeka HyQvia u usporedbi s intravenskom primjenom IG-a 10% Parametar
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).
Croatian: Medijan broja mjesta primjene infuzije mjesečno za lijek HyQvia bio je 1,09, što je malo niže od medijana broja mjesta primjene infuzije za intravenski IG 10% koja su korištena u ispitivanju (1,34), a znatno niži od medijana broja mjesta primjene infuzije koja su korištena u ispitivanju supkutane primjene IG-a 10% (21,43).
English: Solutions that are cloudy or have deposits should not be used.
Croatian: Otopine koje su mutne ili imaju naslage ne smiju se koristiti.
English: The vial of immunoglobulins has been prepared from the blood of healthy people.
Croatian: Bočica imunoglobulina pripremljena je od krvi zdravih osoba.
English: 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.
Croatian: Na početku terapije preporučuje se postupno produljivanje terapijskih razmaka za prve infuzije, s 1 tjedna između doza na 3 ili 4 tjedna.
English: No skin changes were observed that did not resolve during the clinical study.
Croatian: Nisu opažene promjene na koži koje se nisu povukle tijekom kliničkog ispitivanja.
English: The listed warnings and precautions apply both to adults and children.
Croatian: Navedena upozorenja i mjere opreza odnose se na odrasle i na djecu.
English: ► If you experience any side effects, you or your guardian must stop the infusion immediately and contact a doctor.
Croatian: ► Ako primijetite bilo koju nuspojavu, Vi ili Vaš staratelj morate odmah zaustaviti infuziju i obavijestiti liječnika.
English: Infuse the full dose per site of IG 10% through the same subcutaneous needle set within 10 minutes of the recombinant human hyaluronidase.
Croatian: Infundirajte punu dozu IG 10% po mjestu kroz isti komplet supkutane igle u roku od 10 minuta od rekombinantne ljudske hijaluronidaze.
English: • Cap: Protective cap is on the dual vial unit.
Croatian: • Zatvarač: zaštitni zatvarač se nalazi na jedinici s dvostrukom bočicom.
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.
Croatian: U slučajevima kada je potrebno više od jedne bočice lijeka IG 10% ili više od jedne bočice rekombinantne ljudske hijaluronidaze da bi se dobila potrebna doza za infuziju, IG 10% i/ili rekombinantnu ljudsku hijaluronidazu trebate pripremiti odvojeno u odgovarajuće spremnike za otopinu prije primjene.
English: ► In such cases, you will be closely monitored during your first infusion and for the first hour after your infusion has stopped.
Croatian: ► U takvim slučajevima bit ćete pažljivo praćeni tijekom prve infuzije i tijekom prvog sata nakon prekida infuzije.
English: The pharmacokinetics of HyQvia were evaluated in a clinical study in patients with PID aged 12 years and older.
Croatian: Farmakokinetika lijeka HyQvia procijenjena je u kliničkom ispitivanju u bolesnika s primarnom imunodeficijencijom u dobi od 12 godina i starijih.