FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.
Croatian: Ovisno o kliničkom odgovoru (npr. stopa infekcije), može se razmotriti prilagodba doze i/ili intervala doziranja na više najniže razine.
English: Aseptic Meningitis Syndrome (AMS)
Croatian: Sindrom aseptičnog meningitisa (AMS)
English: ► if you suffer from hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood).
Croatian: ► ako patite od hiperprolinemije (genetski poremećaj koji uzrokuje visoke razine aminokiseline prolina u krvi).
English: Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.
Croatian: Imunoglobulini su također poznati kao protutijela, to su proteini krvi koji pomažu Vašem organizmu u borbi protiv infekcija.
English: Administer solution which is at room or body temperature.
Croatian: Upotrebljavajte otopinu koja je na sobnoj ili tjelesnoj temperaturi.
English: L-proline
Croatian: L-prolin
English: Posology Adults and children (0-18 years)
Croatian: Odrasli i djeca (0-18 godina)
English: It is believed that the body's defense attack underlines such inflammation, and the immunoglobulins present in Hizentra help to protect the nerves from being attacked (immunomodulatory therapy).
Croatian: Smatra se da obrana tijela svojim napadom potiče takve upale, a imunoglobulini prisutni u Hizentri pomažu u zaštiti živaca kako ne bi bili napadnuti (imunomodulacijska terapija).
English: Direct comparative data for Hizentra versus IVIG are not available.
Croatian: Izravni usporedni podaci za Hizentru naspram i.v.Ig nisu dostupni.
English: Your doctor will decide if further tests are necessary and whether Hizentra should be continued.
Croatian: Vaš će liječnik odlučiti jesu li potrebne daljnje pretrage i treba li prekinuti uzimanje lijeka Hizentra.
English: It may happen particularly if you do not have enough of the immunoglobulin type A (IgA) in your blood (IgA deficiency).
Croatian: Do njih osobito može doći u slučaju ako nemate dovoljno imunoglobulina tipa A (IgA) u krvi (nedostatak IgA).
English: The patient or a caregiver must be instructed in the use of infusion devices, the keeping of treatment diary, recognition of and measures to be taken in case of severe adverse reactions.
Croatian: Bolesnika ili njegovatelja mora se uputiti u uporabu uređaja za infuziju, vođenje dnevnika liječenja, prepoznavanje i mjere koje treba poduzeti u slučaju teških nuspojava.
English: If using a transfer device (vented spike), follow the instructions provided by the device manufacturer.
Croatian: Ako upotrebljavate napravu za prijenos (ventilirani šiljak), slijedite upute koje je propisao proizvođač naprave.
English: Information available from clinical trials showed no difference in the safety profile of patients ≥ 65 years of age than of younger patients.
Croatian: Informacije dostupne iz kliničkih ispitivanja pokazale su da nema razlike u sigurnosnom profilu bolesnika u dobi od ≥ 65 godina u odnosu na mlađe bolesnike.
English: Then, insert the needle into the center of the vial stopper and, to avoid foaming, inject air into headspace of the vial (not into the liquid).
Croatian: Nakon toga, umetnite iglu u središnji dio čepa bočice i, kako biste izbjegli pjenjenje, u bočicu ubrizgajte zrak u prostor iznad tekućine (ne u tekućinu).
English: It is strongly recommended that every time you receive a dose of Hizentra the name and batch number of the product are recorded in order to maintain a record of the batches used (see section 3 “How to use Hizentra”).
Croatian: Snažno se preporučuje da svaki put kada primite dozu Hizentre zabilježite ime i broj serije lijeka kako biste pratili koje serije lijeka koristite. (vidjeti dio 3 "Kako primjenjivati Hizentru").
English: In case of clinical deterioration the dose may be increased to the recommended maximum of 0.4g/kg weekly dose.
Croatian: U slučaju kliničkog pogoršanja dozu se može povećati do preporučene maksimalne doze od 0,4 g/kg tjedno.
English: Treatment of patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies).
Croatian: Liječenje bolesnika koji su rođeni sa smanjenom sposobnošću ili nemogućnost stvaranja imunoglobulina (primarne imunodeficijencije).
English: Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
Croatian: Nadomjesna terapija u odraslih, djece i adolescenata (0-18 godina) kod: − Sindroma primarne imunodeficijencije s poremećajem stvaranja protutijela (vidjeti dio 4.4).
English: These things may increase your risk of having a blood clot after using Hizentra.
Croatian: To može povećati Vaš rizik za krvne ugruške nakon uzimanja lijeka Hizentra.
English: After infusion of immunoglobulin 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 infuzije imunoglobulina, prolazni porast različitih pasivno prenesenih protutijela u krvi bolesnika može rezultirati pogrešnim tumačenjem pozitivnih nalaza serološkog testiranja.
English: Using smaller needles (i.e. higher gauge number) may make it more difficult to manually push Hizentra.
Croatian: Korištenje igle manjeg promjera (odnosno veći G broj) može otežati ručno potiskivanje lijeka Hizentra.
English: Your healthcare professional may adjust the dose based on your response to the treatment.
Croatian: Zdravstveni radnik može prilagoditi dozu temeljem Vašeg odgovora na liječenje.
English: Your doctor will decide whether you can receive Hizentra during your pregnancy or while you are breast-feeding.
Croatian: Vaš liječnik će odlučiti smijete li primiti Hizentru za vrijeme trudnoće ili dok dojite.
English: Hizentra is made from human blood plasma (this is the liquid part of the blood).
Croatian: Hizentra je dobivena od plazme ljudske krvi (plazma je tekući dio krvi).
English: Immunomodulatory therapy in adults, children and adolescents (0-18 years):
Croatian: Imunomodulacijska terapija u odraslih, djece i adolescenata (0-18 godina):
English: However, if missed doses were not replaced when dosing was resumed, it took up to 5-6 weeks for the IgG trough levels to return to steady-state.
Croatian: Međutim, ako propuštene doze nisu bile nadoknađene nakon što je doziranje ponovno uspostavljeno, trebalo je proći do 5-6 tjedana kako bi se najniže razine IgG-a vratile u stanje dinamičke ravnoteže.
English: Your doctor will calculate the correct dose for you taking into account your weight and response to treatment.
Croatian: Vaš liječnik će izračunati točnu dozu za Vas uzimajući u obzir težinu i odgovor na liječenje.
English: In these rare cases allergic reactions, such as a sudden fall in blood pressure or shock may occur (see also section 4 “Possible side effects”).
Croatian: U tim rijetkim slučajevima, mogu se pojaviti alergijske reakcije kao što su nagli pad krvnog tlaka ili šok (vidjeti također dio 4 "Moguće nuspojave").
English: Simulation of 2-3 missed daily doses resulted in a median serum IgG level decrease of ≤ 4% compared to consistent daily dosing.
Croatian: Simulacija 2-3 propuštene dnevne doze rezultirala je medijanom smanjenja razine IgG u serumu od ≤ 4 % u usporedbi s dosljednim dnevnim doziranjem.
English: Meningitis aseptic
Croatian: Aseptički meningitis
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell allo-antibodies (Coombs' test).
Croatian: Pasivni prijenos protutijela na antigene eritrocita, npr. A, B, D, može interferirati s nekim serološkim testovima na aloprotutijela eritrocita (npr. Coombsov test).
English: More than one infusion device can be used simultaneously.
Croatian: Istovremeno se može upotrijebiti više od jednog uređaja za infuziju.
English: • Pain related to the musculature and bones (musculoskeletal pain)
Croatian: • Bol povezana s mišićima i kostima (mišićno-koštana bol)
English: CIDP is characterised by chronic inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and arms.
Croatian: Značajka KUDP-a je kronična upala perifernih živaca koja uzrokuje slabost mišića i/ili utrnulost uglavnom nogu i ruku.
English: Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when treatment has been stopped for more than eight weeks.
Croatian: Određene nuspojave mogu se pojaviti češće u bolesnika koji primaju ljudski normalni imunoglobulin po prvi put ili, u rijetkim slučajevima, kada se prelazi s jednog na drugi pripravak ljudskog normalnog imunoglobulina ili kada je liječenje zaustavljeno na više od osam tjedana.
English: Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
Croatian: U slučaju sumnje na alergijsku ili anafilaktičku reakciju, potrebno je hitno prekinuti infuziju.
English: Subjects in both Hizentra dose groups remained stable in electrophysiology parameters.
Croatian: Ispitanici u obje Hizentra dozne skupine ostali su stabilni u elektrofiziološkim parametrima.
English: The maximum IgA content is 50 micrograms/ml.
Croatian: Maksimalna količina IgA je 50 mikrograma/ml.
English: Tell your doctor about your treatment with Hizentra prior to any blood test.
Croatian: Obavijestite svog liječnika da se liječite Hizentrom prije bilo kakvih krvnih pretraga.
English: 5 Preparation of Hizentra for infusion The 5 ml and 10 ml pre-filled syringes are supplied fully assembled and ready to use.
Croatian: 5 Priprema Hizentre za infuziju Napunjene štrcaljke od 5 ml i od 10 ml isporučuju se potpuno sastavljene i spremne za uporabu.
English: Your doctor will determine the appropriate infusion technique and the infusion rate for you taking into account your individual dose, dosing frequency and product tolerability.
Croatian: Vaš liječnik će odrediti prikladnu tehniku infuzije i brzinu infuzije za Vas uzimajući u obzir vašu pojedinačnu dozu, učestalost doziranja i podnošljivost lijeka.
English: The therapy with Hizentra is initiated 1 week after the last IVIg infusion.
Croatian: Terapija s Hizentrom započinje 1 tjedan nakon posljednje i.v.Ig infuzije.
English: Subjects received in total 2,264 weekly Hizentra infusions.
Croatian: Bolesnici su ukupno primili 2264 infuzije Hizentre tjedno.
English: Dizziness, Migraine
Croatian: Omaglica, migrena
English: • lack of certain immunoglobulin G subclasses causing recurrent infections.
Croatian: • nedostatak određenih podvrsta imunoglobulina G koji uzrokuje opetovane infekcije.
English: What you need to know before you use Hizentra
Croatian: Što morate znati prije nego počnete primjenjivati Hizentru
English: •the testing of each donation and pools of plasma for signs of virus/infections.
Croatian: • ispitivanje svake donacije i uzoraka udružene plazme više donora kako bi se uočili potencijalni znakovi virusa/infekcija.
English: Hizentra contains residual amounts of IgA which might cause an allergic reaction.
Croatian: Hizentra sadrži ostatne količine IgA koje bi mogle prouzročiti alergijsku reakciju.
English: Individualize the duration of any treatment beyond 18months based upon the patient's response and demonstrated need for continued therapy.
Croatian: Za svakog se bolesnika zasebno odlučuje o trajanju bilo kojeg liječenja dulje od 18 mjeseci na temelju bolesnikovog odgovora i dokazane potrebe za daljnjom terapijom.
English: A loading dose of at least 0.2 to 0.5 g/kg (1.0 to 2.5 ml/kg) body weight may be required.
Croatian: Može biti potrebna udarna doza od najmanje 0,2 do 0,5 g/kg (1,0 - 2,5 ml/kg) tjelesne težine.
English: • The volume of product infused into a particular site may vary.
Croatian: • Volumen koji se daje infuzijom na određeno mjesto može biti različit.
English: Responder: in the pump-assisted group a subject who performed ≥3 valid infusions out of 4 for an infusion parameter; in the manual push group a subject who performed ≥60 % of valid infusions for an infusion parameter.
Croatian: Ispitanik s uspjehom: u skupini s primjenom pumpe je to ispitanik koji je obavio ≥3 valjane infuzije od 4 predviđene za infuzijski parametar; u skupini s ručnim potiskom to je ispitanik koji je obavio ≥60% valjanih infuzija za infuzijski parametar.
English: Following this, maintenance doses may be given at repeated intervals, from daily to once every two weeks, to reach a cumulative monthly dose of about 2 to 4 ml/kg of body weight.
Croatian: Nakon toga, doza održavanja se može primijeniti u ponavljajućim intervalima, od jedanput dnevno do jedanput svaka dva tjedna, dok se ne dostigne kumulativna mjesečna doza od oko 2-4 ml/kg tjelesne težine.
English: After receiving Hizentra, the results of certain blood tests (serological tests) may be impaired for a certain time.
Croatian: Testiranja krvi Nakon primanja Hizentre, vrijednosti rezultata nekih krvnih pretraga (seroloških testova) mogu biti umanjene na određeno vrijeme.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Each single dose may need to be injected at different anatomic sites.
Croatian: Svaku pojedinačnu dozu možda će biti potrebno ubrizgati u različite dijelove tijela.
English: There were no differences in the pharmacokinetics, safety and efficacy profiles as compared with adult subjects.
Croatian: Nisu zapažene razlike profila u farmakokinetici, sigurnosti i djelotvornosti u usporedbi s odraslim ispitanicima.
English: Prime the tubing to eliminate all remaining air.
Croatian: Potisnite otopinu u cijev kako biste uklonili sav preostali zrak.
English: In a third group, infusion volumes of 25, 40 and 50ml per site were additionally evaluated in pump-assisted administration of weekly Hizentra doses (n=15).
Croatian: U trećoj skupini, volumeni infuzije od 25, 40 i 50 ml po mjestu dodatno su procijenjeni u primjeni pomoću pumpe kod tjednih doza Hizentre (n = 15).
English: Subjects received in total 1,831 weekly Hizentra infusions.
Croatian: Ispitanici su ukupno primili 1831 infuzije Hizentre tjedno.
English: Patients may experience effects, such as dizziness or nausea, during treatment with Hizentra that might affect the ability to drive and use machines.
Croatian: Bolesnici mogu primjetiti učinke, kao što su vrtoglavica ili mučnina, tijekom liječenja s Hizentrom koji mogu utjecati na sposobnost upravljanja vozilima i strojevima.
English: Tell your doctor if you have a history of heart or blood vessel disease or blood clots, have thick blood, or have been immobile for some time.
Croatian: Obavijestite svog liječnika ako imate anamnezu bolesti srca ili krvnih žila ili krvnih ugrušaka, ako imate gustu krv ili ako ste već neko vrijeme nepokretni.
English: Following subcutaneous administration of Hizentra, peak serum levels are achieved after approximately 2 days.
Croatian: Nakon supkutane primjene Hizentre, vršne razine u serumu postignute su nakon približno 2 dana.
English: Hizentra belongs to the class of medicines called human normal immunoglobulins.
Croatian: Hizentra pripada skupini lijekova koji se nazivaju ljudskim normalnim imunoglobulinima.
English: Thereafter, the infusion rate can be increased further as per your tolerability.
Croatian: Nakon toga, brzina infuzije se može dalje povećati u skladu s Vašom podnošljivosti.
English: Information on safety with respect to transmissible agents 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: Informacije o sigurnosti s obzirom na prenosive agense Standardne mjere za sprječavanje infekcija koje mogu nastati uslijed korištenja lijekova dobivenih iz ljudske krvi ili plazme uključuju odabir donora, analizu pojedinačnih donacija i udružene plazme više donora (“pulovi”) u svrhu otkrivanja specifičnih markera infekcija te provedbu učinkovitih koraka u proizvodnji za inaktivaciju /uklanjanje virusa.
English: • Administer Hizentra under the skin only.
Croatian: • Hizentru smijete primijeniti samo pod kožu (supkutano).
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration, ATC code: J06BA01.
Croatian: Farmakoterapijska skupina: imunoserumi i imunoglobulini: imunoglobulini, normalni ljudski, za ekstravaskularnu primjenu, ATK oznaka: J06BA01.
English: • the batch number of the medicine, and
Croatian: • broj serije lijeka, i
English: Distribution of the IgG subclasses (approx. values): IgG1 ...........69%
Croatian: Distribucija IgG podvrste (približne vrijednosti): IgG1 ..........
English: Trough levels should be measured and assessed in conjunction with the patient's clinical response.
Croatian: Najniže razine potrebno je mjeriti i ocijeniti u odnosu na klinički odgovor bolesnika.
English: Efficacy of Hizentra has been demonstrated over placebo after switching from intravenous immunoglobulins (IVIG).
Croatian: Djelotvornost Hizentre nad placebom je dokazana nakon prebacivanja sa intravenski primjenjivanih imunoglobulina (i.v.Ig).
English: 2 Assemble supplies Place Hizentra and other supplies and equipment needed for the infusion on a clean, flat surface.
Croatian: Postavite Hizentru i ostali pribor i opremu koji su potrebni za infuziju na čistu, ravnu površinu.
English: The safety, efficacy and tolerability of Hizentra in patients with CIDP has been assessed in a multicentre, double-blind, randomised, placebo-controlled, parallel-group phase III PATH [Polyneuropathy and Treatment with Hizentra] study.
Croatian: Sigurnost, djelotvornost i podnošljivost Hizentre u bolesnika s KUDP-om procijenjena je u multicentričnom, dvostruko slijepom, randomiziranom, placebom kontroliranom PATH [Polyneuropathy and Treatment with Hizentra] ispitivanju faze III, s paralelnim skupinama.
English: If you notice such signs during the infusion of Hizentra, stop the infusion and go to the nearest hospital immediately.
Croatian: Ako primijetite takve reakcije tijekom infuzije Hizentre, odmah prekinite infuziju i otiđite u najbližu bolnicu.
English: Hizentra must not be given intravascularly.
Croatian: Hizentra se ne smije dati intravaskularno.
English: The recommended subcutaneous dose is 0.2 to 0.4 g/kg body weight per week administered in 1 or 2 sessions over 1 or 2 consecutive days.
Croatian: Preporučena supkutana doza je 0,2 do 0,4 g/kg tjelesne težine po tjednu primijenjena jednom ili dvaput tijekom 1 ili 2 uzastopna dana.
English: Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be switched to Hizentra only under close medical supervision.
Croatian: Bolesnike s anti-IgA protutijelima, kod kojih se supkutana terapija IgG pripravcima pokazala jedinim izborom liječenja, trebalo bi prebaciti na Hizentru samo pod strogim liječničkim nadzorom.
English: If the pre-filled syringe can be placed directly on the pump, then go to Step 6.
Croatian: Ako se napunjena štrcaljka može postaviti direktno na pumpu, onda prijeđite na točku broj 6.
English: • You may use an unlimited number of sites simultaneously.
Croatian: • Možete primijeniti infuzije u neograničen broj mjesta istovremeno.
English: In immunodeficiency, adequate doses of Hizentra may restore abnormally low immunoglobulin G antibody levels to the normal range and thus help against infections.
Croatian: Kod imunodeficijencije odgovarajuće doze Hizentre mogu vratiti abnormalno nisku razinu protutijela imunoglobulina G u normalan raspon i time pomoći protiv infekcija.
English: Thereafter, if the patient tolerates the initial infusions at the full dose per site and maximum rate, an increase in the infusion rate of successive infusions may be considered at the discretion of the patient and based on the healthcare professionals' judgement.
Croatian: Nakon toga, ako bolesnik podnosi početne infuzije u punoj dozi po mjestu i maksimalnoj brzini, povećanje brzine uzastopnih infuzija može se razmotriti prema odluci bolesnika i na temelju procjene zdravstvenih radnika.
English: Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae.
Croatian: Prekid liječenja imunoglobulinima može uzrokovati remisiju AMS-a unutar nekoliko dana bez posljedica.
English: If using a needle, pull back on the plunger to draw air into the syringe that is comparable to the amount of Hizentra to be withdrawn.
Croatian: Ako upotrebljavate iglu, povucite klip kako bi u štrcaljku ušao zrak koji odgovara količini Hizentre koju treba povući.
English: The difference observed between the 0.2 g/kg bw and the 0.4 g/kg bw Hizentra groups did not reach statistical significance.
Croatian: Razlika između skupine na Hizentri 0,2 g/kg tt i skupine na 0,4 g/kg tt nije dosegla statističku značajnost.
English: Follow the steps below and use aseptic technique to administer Hizentra.
Croatian: Slijedite korake u nastavku i koristite aseptičke tehnike prilikom primjene Hizentre.
English: Hizentra is used to raise abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy).
Croatian: Hizentra se koristi za podizanje abnormalno niske razine imunoglobulina u krvi na normalnu razinu (nadomjesna terapija).
English: • Reactions at the infusion site
Croatian: • Reakcije na mjestu infuzije
English: Do NOT infuse Hizentra ► if you are allergic to human immunoglobulins, polysorbate 80 or L-proline.
Croatian: Nemojte primjeniti infuziju Hizentre: ► ako ste alergični na ljudski imunoglobulin, polisorbat 80 ili L-prolin.
English: Please tell your doctor prior to treatment.
Croatian: Molimo obavijestite o tome svog liječnika prije nego što započnete liječenje.
English: Transfer Hizentra to syringe for infusion - Attach a transfer device or needle to a sterile syringe, using aseptic technique.
Croatian: Prebacite Hizentru u štrcaljku za infuziju - Pričvrstite napravu za prijenos ili iglu na sterilnu štrcaljku, primjenom aseptičke tehnike.
English: In replacement therapy the dose may need to be individualised for each patient dependent on the clinical response and serum IgG trough levels.
Croatian: U nadomjesnoj terapiji možda će biti potrebno individualiziranje doze za svakog bolesnika ovisno o kliničkom odgovoru te najnižim razinama IgG-a u serumu.
English: See leaflet for further information.
Croatian: Pogledajte uputu o lijeku za dodatne informacije.
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 in replacement therapy indications.
Croatian: Pedijatrijska populacija Doziranje u djece i adolescenata (0-18 godina) ne razlikuje se od onog u odraslih s obzirom na to da je doziranje za svaku pojedinu indikaciju dano u odnosu na tjelesnu težinu te je prilagođeno kliničkom ishodu u indikacijama nadomjesne terapije.
English: All pre-filled syringes have a standard luer lock, which is a screw connection at the syringe tip that creates a leak-free seal.
Croatian: Sve napunjene štrcaljke imaju na vrhu standardni luer lock priključak s navojem koji stvara nepropusno brtvilo.
English: Postmarketing experience with Hizentra in patients ≥ 65 years of age shows an overall similar safety profile in this age group as in younger patients.
Croatian: Iskustvo s Hizentrom u bolesnika u dobi od ≥ 65 godina nakon stavljanja lijeka u promet pokazuje ukupno sličan sigurnosni profil u ovoj dobnoj skupini kao i u mlađih bolesnika.