FrancophonIA/ELRC3.0 huggingface dataset:
English: To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (> 6 g/l).
Croatian: Kako bi se smanjila stopa infekcije, možda bude potrebno povisiti doziranje s ciljem postizanja viših najnižih koncentracija (> 6 g/l).
English: Consider using longer needles and/or more than one infusion site.
Croatian: Razmotrite korištenje dužih igli i/ili više od jednog mjesta primjene infuzije.
English: However, needles with smaller diameters may be used if slower flow rates are acceptable.
Croatian: Međutim, igle manjeg promjera mogu se koristiti ako su prihvatljive sporije brzine protoka.
English: Terminal half life [days]
Croatian: Terminalni poluvijek [dani]
English: This may occur if you have IgA deficiency.
Croatian: Do toga može doći ako imate nedostatak IgA-a.
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Croatian: IgG i kompleksi IgG-a razgrađuju se u stanicama retikuloendotelnog sustava.
English: Unlike the stable structural components of the interstitial matrix, hyaluronan has a very fast turnover with half-life of approximately 0.5 days.
Croatian: Za razliku od stabilnih strukturnih komponenti intersticijskog matriksa, hijaluronan se vrlo brzo razgrađuje s poluvijekom od otprilike 0,5 dana.
English: In the case of measles, this impairment may persist for up to 1 year.
Croatian: Kod ospica ta oslabljenost može trajati do godine dana.
English: Your doctor may also adjust your dose depending on your response to treatment.
Croatian: Nadalje, Vaš liječnik može prilagoditi dozu ovisno o Vašem odgovoru na liječenje.
English: HyQvia contains many different antibodies, some of which can affect blood tests (serological tests).
Croatian: HyQvia sadrži mnogo različitih protutijela, a neka od njih mogu utjecati na krvne pretrage (serološke pretrage).
English: Spread of localised infections
Croatian: Širenje lokaliziranih infekcija
English: Hypertension, blood pressure increase
Croatian: Krvožilni poremećaji hipertenzija, povišeni krvni tlak
English: In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response.
Croatian: U nadomjesnoj terapiji možda će biti potrebno individualizirati dozu za svakog bolesnika ovisno o farmakokinetici i kliničkom odgovoru.
English: Frequencies per infusion have been evaluated using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Croatian: Učestalosti po infuziji procijenjene su na temelju sljedećih konvencija: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Like all medicines, this medicine can have side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: • Note: Your healthcare professional may recommend using a “Y” connector (for more than one site) or other needle set configuration.
Croatian: • Napomena: Vaš zdravstveni radnik može preporučiti uporabu ”Y” priključka (za više od jednog mjesta primjene infuzije) ili drugi komplet igle.
English: AUC per week [g*days/l]
Croatian: AUC tjedno [g*dani/l]
English: Ask your doctor or pharmacist or nurse if another needle size would be more appropriate for you.
Croatian: Pitajte svog liječnika, ljekarnika ili medicinsku sestru bi li druga veličina igle bila prikladnija za Vas.
English: Since HyQvia contains trace amounts of IgA, you might have an allergic reaction.
Croatian: Budući da HyQvia sadrži IgA u tragovima, mogli biste imati alergijsku reakciju;
English: Date of first authorisation: 16 May 2013 Date of renewal: 8 Jan 2018
Croatian: Datum obnove odobrenja: 08. siječnja 2018.
English: • Repeat this step if you have a second infusion site.
Croatian: • Ponovite taj korak ako je predviđeno i drugo mjesto primjene infuzije.
English: Effects on blood tests
Croatian: Utjecaj na krvne pretrage
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).
Croatian: Sedamdeset osam (78) od 83 (94%) ispitanika dostigli su isto doziranje s razmakom od 3 ili 4 tjedna, dok je jedan ispitanik smanjio razmak s 4 na 3 tjedna, jedan s 4 na 2 tjedna, a jedan s 3 na 2 tjedna (2 ispitanika ispala su iz studije tijekom razdoblja titracije).
English: • ensuring that patients are carefully monitored for any symptoms throughout the infusion period.
Croatian: • osiguravajući da su bolesnici pažljivo nadzirani praćenjem svih simptoma tijekom trajanja infuzije.
English: HyQvia is prescribed as replacement therapy to patients who do not have sufficient antibodies, including the following groups:
Croatian: HyQvia se propisuje kao nadomjesna terapija za bolesnike koji nemaju dovoljno protutijela, uključujući sljedeće skupine:
English: Distribution of the IgG subclasses (approx. values): IgG1  56.9%
Croatian: Raspodjela podvrsta IgG (približne vrijednosti): IgG1 ≥ 56,9%
English: If you use more HyQvia than you should
Croatian: Ako primijenite više lijeka HyQvia nego što ste trebali
English: In the beginning you will receive one quarter of this dose at 1 week intervals.
Croatian: Na početku ćete dobivati četvrtinu navedene doze u razmacima od 1 tjedna.
English: The medicine works in exactly the same way as the immunoglobulins naturally present in the blood.
Croatian: Lijek djeluje potpuno na isti način kao i imunoglobulini koji su prirodno prisutni u krvi.
English: Other medicines and HyQvia
Croatian: Drugi lijekovi i HyQvia
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se također odnosi na sve nepoznate ili nove viruse ili druge vrste infekcija.
English: • Tell your doctor or nurse immediately if you notice any of these signs during the infusion.
Croatian: • Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koji od navedenih znakova tijekom infuzije.
English: o Select sites on the opposite sides of the body if instructed to infuse in two sites for doses above 600 ml.
Croatian: ο Odaberite mjesta na suprotnim stranama tijela ako ste dobili uputu da infuziju primite na dva mjesta pri dozama iznad 600 ml.
English: Apparent clearance or clearance [ml/kg/day] 1.6 (1.4 to 1.79)
Croatian: Prividni klirens ili klirens [ml/kg/dan] 1,6 (1,4 do 1,79)
English: HyQvia must not be given intravenously or intramuscularly.
Croatian: HyQvia se ne smije davati intravenski ili intramuskularno.
English: Detailed Instructions for Use are provided in the section below.
Croatian: Detaljne upute za uporabu pronaći ćete u nastavku.
English: • Write down the date, time, dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion.
Croatian: • Zapišite datum, vrijeme, dozu, mjesto/a infuzije (kako bi Vam pomoglo pri kružnom mijenjanju mjesta) i bilo kakve reakcije nakon svake infuzije.
English: • Pull the needle wings straight up and out.
Croatian: • Povucite jezičke igle ravno prema gore i prema van.
English: • Expiration date: Do not use beyond expiration date.
Croatian: • Rok trajanja: nemojte koristiti nakon isteka roka valjanosti.
English: Remove HyQvia from the box:
Croatian: Izvadite lijek HyQvia iz kutije:
English: The first infusion of HyQvia should be given one week after the last treatment with the previous immunoglobulin.
Croatian: Prvu infuziju lijeka HyQvia treba dati tjedan nakon zadnje terapije s prethodnim imunoglobulinom.
English: In case of shock, immediately discontinue the infusion and treat the patient for shock.
Croatian: U slučaju šoka odmah prekinite infuziju i liječite bolesnika od šoka.
English: The listed interactions apply both to adults and children.
Croatian: Navedena interakcije odnose se na odrasle i na djecu.
English: Side effects seen with similar medicines
Croatian: Nuspojave zabilježene sa sličnim lijekovima
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.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka HyQvia u jednoj ili više podskupina pedijatrijske populacije u liječenju primarne imunodeficijencije kao model za nadomjesnu terapiju.
English: During the infusion you must look out for first signs of side effects (for further details see section 4, “Possible side effects”).
Croatian: Tijekom infuzije morate prepoznati prve znakove nuspojava (za više informacija pogledajte dio 4, ”Moguće nuspojave”).
English: ► Tell your doctor about your treatment with HyQvia before any blood test.
Croatian: Obavijestite liječnika o Vašem liječenju lijekom HyQvia prije bilo koje krvne pretrage.
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.
Croatian: Doziranje u djece i adolescenata (0-18 godina) ne razlikuje se od doziranja u odraslih bolesnika jer se doza za svaku indikaciju daje prema tjelesnoj težini i prilagođava kliničkom ishodu gore navedenog stanja.
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.
Croatian: Prilagodite učestalost i broj mjesta primjene infuzije, uzimajući u obzir volumen, ukupno vrijeme infuzije i podnošljivost tako da bolesnik prima istu tjednu ekvivalentnu dozu.
English: The overall combined exposure of PID patients in both studies was 187.69 patient-years; the longest exposure for adults was 3.8 years and 3.3 years for paediatric patients.
Croatian: Ukupna kombinirana izloženost bolesnika s primarnom imunodeficijencijom u oba ispitivanja bila je 187,69 bolesnik-godina; najduža izloženost odraslih bila je 3,8 godina, a pedijatrijskih bolesnika 3,3 godine.
English: The contents of each vial are described below:
Croatian: Sadržaj svake bočice opisan je u nastavku:
English: This guardian should help you keep an eye on potential side effects.
Croatian: Staratelj Vam mora pomoći da pripazite na moguće nuspojave.
English: • Remove the needle cover.
Croatian: • Skinite pokrov igle.
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.
Croatian: Ako su bolesnici prethodno bili na režimu doziranja s razmakom od 3 tjedna, produžavanje razmaka na 4 tjedna može se postići primjenom istih tjednih ekvivalenata.
English: The same indications, dose and frequency of infusion as for adults apply for children and adolescents (0-18 years).
Croatian: Iste indikacije, doza i učestalost infuzije kao za odrasle primjenjuju se za djecu i adolescente (0-18 godina).
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).
Croatian: HyQvia je procijenjena u 24 pedijatrijskog bolesnika, uključujući 13 bolesnika u dobi između 4 i < 12 godina i 11 bolesnika u dobi između 12 i < 18 godina, koji su liječeni do 3,3 godine uz ukupno iskustvo u sigurnosti primjene jednako 48,66 bolesnik-godina (kao što je opisano u dijelu Klinička djelotvornost i sigurnost).
English: Results of clinical studies indicate similar safety profiles in adults and paediatric population, including the nature, frequency, seriousness and reversibility of adverse reactions.
Croatian: Rezultati kliničkih ispitivanja pokazali su slične sigurnosne profile kod odrasle i pedijatrijske populacije, uključujući prirodu, učestalost, ozbiljnost i reverzibilnost nuspojava.
English: No adverse effects on pregnancy and foetal development were associated with anti-rHuPH20 antibodies.
Croatian: Nikakvi štetni učinci na trudnoću i fetalni razvoj nisu bili povezani s anti-rHuPH20 protutijelima.
English: Therefore, after receiving HyQvia, you may have to wait for up to 3 months before receiving certain vaccines.
Croatian: Stoga, nakon što primite lijek HyQvia, možda ćete morati pričekati do 3 mjeseca prije primanja određenih cjepiva.
English: Long-term animal studies to evaluate the carcinogenic or mutagenic potential of recombinant human hyaluronidase have not been conducted.
Croatian: Dugoročna ispitivanja na životinjama radi ispitivanja karcinogenog ili mutagenog potencijala rekombinantne ljudske hijaluronidaze nisu provedena.
English: The effects of the hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.
Croatian: Učinci hijaluronidaze su reverzibilni i propusnost supkutanog tkiva ponovno se uspostavlja. unutar 24 do 48 sati.
English: • Check each vial of HyQvia before using:
Croatian: • Provjerite svaku bočicu lijeka HyQvia prije primjene:
English: What HyQvia is and what it is used for
Croatian: Što je HyQvia i za što se koristi
English: Partially used vials should be discarded.
Croatian: Djelomično iskorištene bočice trebate baciti.
English: Any change of needle size would have to be supervised by the treating physician.
Croatian: Svaku promjenu veličine igle treba nadzirati nadležni liječnik.
English: What HyQvia looks like and contents of the pack
Croatian: Kako HyQvia izgleda i sadržaj pakiranja
English: You are at increased risk of allergic reactions if you have IgA deficiency with anti-IgA antibodies.
Croatian: Kod Vas postoji povećani rizik od alergijskih reakcija ako imate nedostatak IgA s protutijelima na IgA.
English: Infections and infestations: Meningitis aseptic
Croatian: Infekcije i infestacije: aseptički meningitis
English: Doctors are aware of these possible side effects and will monitor you during and after the initial infusions.
Croatian: Liječnici su svjesni mogućih nuspojava i pratit će Vas tijekom i nakon početnih infuzija.
English: A-1221 Vienna, Austria
Croatian: A-1221 Vienna, Austrija
English: Patients were treated with HyQvia at either 3- or 4-week treatment intervals for a total of 12 months (following a brief titration period).
Croatian: Bolesnici su liječeni lijekom HyQvia u razmacima od 3 ili 4 tjedna tijekom ukupno 12 mjeseci (nakon kratkog razdoblja titracije).
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).
Croatian: Rezultati ispitivanja pokazali su stopu potvrđenih, akutnih, teških bakterijskih infekcija godišnje tijekom terapije lijekom HyQvia od 0,025 (gornja granica 99%-tnog jednostranog intervala pouzdanosti bila je 0,046).
English: The most frequently reported systemic ARs were headache, fatigue and pyrexia.
Croatian: Najčešće prijavljivane sistemske nuspojave bile su glavobolja, umor i pireksija.
English: Do not infuse HyQvia into or around an infected or red swollen area on your skin because it may cause the infection to spread.
Croatian: Nemojte dati infuziju lijeka HyQvia u ili oko zaraženog ili crvenog, oteklog područja na koži jer to može izazvati širenje infekcije.
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.
Croatian: Lijek se ne smije infundirati na ili oko inficiranih ili akutno upaljenih područja zbog potencijalnog rizika od širenja lokalizirane infekcije.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, potrebno je jasno zabilježiti naziv i broj serije primijenjenog lijeka.
English: HyQvia can be used to administer a full therapeutic dose in one to two sites up to every four weeks.
Croatian: HyQvia se može upotrebljavati za primjenu pune terapijske doze na jednom ili dva mjesta do svaka četiri tjedna.
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.
Croatian: Kada Vaš liječnik ili medicinska sestra pronađe ispravnu dozu i brzinu infuzije za Vas, možda će Vam dopustiti da se sami liječite kod kuće.
English: If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable.
Croatian: Ako bolesnik propusti dozu, primijenite propuštenu dozu što je prije moguće i potom nastavite s planiranim terapijama kako je primjenjivo.
English: Record the infusion:
Croatian: Zabilježite infuziju:
English: You and your guardian will be trained to detect early signs of side effects, especially allergic reactions.
Croatian: Vi i Vaš staratelj bit ćete upoznati s ranim znakovima nuspojava, osobito alergijskih reakcija.
English: In all other cases you should be monitored during the infusion and for at least 20 minutes after you receive HyQvia for the first few infusions.
Croatian: U svim ostalim slučajevima trebate biti praćeni tijekom infuzije i tijekom najmanje 20 minuta nakon što dobijete lijek HyQvia tijekom prvih nekoliko infuzija.
English: • If possible, combine all of the recombinant human hyaluronidase needed for the entire dose of IgG into the same syringe.
Croatian: • Ako je moguće, sakupite svu rekombinantnu ljudsku hijaluronidazu koju trebate za cijelu dozu IgG-a u istu štrcaljku.
English: There are currently no clinical safety data for HyQvia on fertility available.
Croatian: Trenutno nisu dostupni klinički podaci o sigurnosti lijeka HyQvia na plodnost.
English: What HyQvia is and what it is used for What you need to know before you use HyQvia How to use HyQvia
Croatian: Što je HyQvia i za što se koristi Što morate znati prije nego počnete primjenjivati lijek HyQvia
English: Remainder of infusion
Croatian: Ostatak infuzije
English: It is unknown whether these antibodies may have any clinical significance in humans.
Croatian: Nije poznato imaju li ta protutijela klinički značaj u ljudi.
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.
Croatian: Ako zatrudnite tijekom primjene lijeka HyQvia, trebali biste s Vašim liječnikom razmotriti mogućnost sudjelovanja u registru trudnoće radi prikupljanja podataka o trudnoći i razvoju djeteta.
English: The IG 10% component provides the therapeutic effect of this medicinal product.
Croatian: Sastojak IG 10% daje terapijski učinak ovom lijeku.
English: ► If you experience a severe side effect, you or your guardian must seek emergency treatment immediately.
Croatian: ► Ako primijetite tešku nuspojavu, Vi ili Vaš staratelj morate odmah potražiti hitnu medicinsku pomoć.
English: The treatment required depends on the nature and severity of the adverse reaction.
Croatian: Potrebno liječenje ovisi o prirodi i težini nuspojave.
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.
Croatian: Morate se strogo pridržavati uputa Vašeg liječnika što se tiče doze, brzine infuzije i rasporeda primanja infuzije lijeka HyQvia kako bi Vaše liječenje bilo uspješno.
English: Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester.
Croatian: Pokazalo se da imunoglobulini prelaze placentu, pojačano tijekom trećeg tromjesečja.
English: Studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction in animals are impracticable due to induction of and interference by developing antibodies to heterologous proteins.
Croatian: Ispitivanja toksičnosti ponovljenih doza, genotoksičnosti i toksičnosti za reprodukciju u životinja ne mogu se provesti zbog indukcije i interferencije protutijela koja se razvijaju na heterologne proteine.
English: Secure the needle to the skin:
Croatian: Pričvrstite iglu za kožu:
English: Nearly all of the subjects were able to attain the same dose interval with HyQvia as they had for intravenous administration.
Croatian: Skoro svi ispitanici uspjeli su dostići isti razmak između doza lijeka HyQvia kakav su imali za intravensku primjenu.
English: Do not infuse a double dose of HyQvia to make up for a missed dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: If two sites are used, the two infusion sites should be on contra lateral sides of the body.
Croatian: Ako za infuziju koristite dva mjesta, ona moraju biti na suprotnim stranama tijela.
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.
Croatian: Sigurnost lijeka HyQvia procijenjena je u 4 klinička ispitivanja (160602, 160603, 160902 i 161101) u 124 jedinstvenih bolesnika s primarnom imunodeficijencijom koji su primali 3202 infuzije.
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)):
Croatian: Osim nuspojava zabilježenih u kliničkim ispitivanja, sljedeće nuspojave prijavljene su nakon stavljanja lijeka u promet (učestalost tih reakcija je nepoznata (ne može se procijeniti iz dostupnih podataka)):
English: Prepare the infusion site:
Croatian: Pripremite mjesto primjene infuzije:
English: Posology The dose and dose regimen are dependent on the indication.
Croatian: Doziranje Doza i režim doziranja ovise o indikaciji.
English: Hypersensitivity to the active substance (IgG) or to any of the excipients listed in section 6.1 (see section 4.4).
Croatian: Preosjetljivost na djelatnu tvar (IgG) ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti dio 4.4).
English: - into a blood vessel (intravenously).
Croatian: - u krvnu žilu (u venu).
English: Subjects ≥ 40 kg
Croatian: Osobe ≥ 40 kg
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Croatian: Proizvođači tih pripravaka također primjenjuju postupke tijekom obrade krvi ili plazme koji mogu deaktivirati ili ukloniti viruse.
English: The majority of these ARs were mild to moderate.
Croatian: Većina navedenih nuspojava bila je blage do umjerene naravi.
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).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak rekombinantne ljudske hijaluronidaze na reprodukcijski potencijal pri dozama korištenima za olakšavanje primjene IG-a 10% (vidjeti dio 5.3).
English: Do not use this medicine if the solutions are cloudy or have particles or deposits.
Croatian: Nemojte primijeniti lijek ako su otopine zamućene ili sadrže čestice ili naslage.
English: No appreciable differences in the pharmacodynamic effects or efficacy and safety of HyQvia were observed between paediatric patients and adults.
Croatian: Nisu opažene značajne razlike u farmakodinamičkom učinku ili u djelotvornosti i sigurnosti lijeka HyQvia između pedijatrijskih i odraslih bolesnika.
English: You may have to wait for up to 1 year after receiving HyQvia before you can receive your measles vaccine.
Croatian: Možda ćete morati pričekati do 1 godine nakon primanja lijeka HyQvia prije nego što budete mogli primiti cjepivo protiv ospica.