FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Ukupnu mjesečnu dozu IG-a 10% treba primijeniti u podijeljenim dozama s razmakom od 1 tjedna, 2 tjedna između doza itd. prema planiranim razmacima terapije lijekom HyQvia.
English: Recombinant human hyaluronidase is a soluble recombinant form of human hyaluronidase that increases the permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan.
Croatian: Rekombinantna ljudska hijaluronidaza je topivi rekombinantni oblik ljudske hijaluronidaze koji pojačava propusnost supkutanog tkiva privremeno depolimerizirajući hijaluronan.
English: 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.
Croatian: Kada se supkutana infuzija lijeka HyQvia koristi za kućno liječenje, terapiju treba započeti i nadzirati liječnik s iskustvom u savjetovanju bolesnika za kućno liječenje.
English: Important information about some of the ingredients of HyQvia
Croatian: Važne informacije o nekim sastojcima lijeka HyQvia
English: Hyaluronan is a polysaccharide found in the intercellular matrix of the connective tissue.
Croatian: Hijaluronan je polisaharid koji se nalazi u međustaničnom matriksu vezivnog tkiva.
English: Flush the pump tubing when the infusion is complete if instructed by your healthcare professional:
Croatian: 16. Isperite cjevčicu pumpe kada je infuzija dovršena, ako Vas je tako uputio zdravstveni radnik:
English: This medicine contains trace amounts of immunoglobulin A (IgA) (not more than 140 micrograms/ml, 37 micrograms on average).
Croatian: Lijek sadrži imunoglobulin A (IgA) u tragovima (ne više od 140 mikrograma/ml, 37 mikrograma u prosjeku).
English: • When treatment is given at home, support from another responsible person should be available for treating adverse reactions or to summon help should a serious adverse reaction occur.
Croatian: • Kada se terapija primjenjuje kod kuće, mora biti dostupna pomoć druge odgovorne osobe za liječenje nuspojava ili pozivanje pomoći ako se pojave ozbiljne nuspojave.
English: Data from the clinical trials of HyQvia show that serum IgG trough levels can be maintained by dosing regimens of 320 to 1,000 mg/kg body weight/4 weeks given at intervals of 3- or 4-weeks.
Croatian: Podaci iz kliničkih ispitivanja primjene lijeka HyQvia pokazali su da se najniže koncentracije IgG-a u serumu mogu održati pri režimima doziranja od 320 do 1000 mg po kg tjelesne težine kroz 4 tjedna davanima u razmacima od 3 ili 4 tjedna.
English: The recombinant human hyaluronidase of HyQvia acts locally.
Croatian: Rekombinantna ljudska hijaluronidaza lijeka HyQvia djeluje lokalno.
English: • If more than one vial is required for a full dose, spike subsequent vials after the first vial has been fully administered.
Croatian: • Ako je za cijelu dozu potrebno više od jedne bočice, probušite sljedeće bočice nakon što ste primijenili u potpunosti prvu bočicu.
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Croatian: U kontroliranim kliničkim ispitivanjima nije utvrđena sigurnost ovog lijeka za primjenu tijekom trudnoće u ljudi i stoga se trudnicama i dojiljama smije davati samo uz oprez.
English: Administer the human normal immunoglobulin 10% with a pump at the rates prescribed by your healthcare professional and start the infusion.
Croatian: Primijenite normalni ljudski imunoglobulin 10% uz pomoć pumpe brzinama koje je propisao Vaš zdravstveni radnik i započnite s infuzijom.
English: SC use only.
Croatian: Samo za s.c. primjenu.
English: Live attenuated virus vaccines
Croatian: Živa atenuirana virusna cjepiva
English: The most frequent adverse reactions reported during post-marketing use of recombinant human hyaluronidase in similar formulations administered subcutaneously for the dispersion and absorption of subcutaneously administered fluids or medicinal products have been mild local infusion site reactions such as erythema and pain.
Croatian: Najčešće nuspojave prijavljivane tijekom praćenja rekombinantne ljudske hijaluronidaze nakon njenog stavljanja u promet, u sličnim formulacijama, primjenjivanima supkutano radi disperzije i apsorpcije supkutano primjenjivanih tekućina ili lijekova, bile su blage lokalne reakcije na mjestima primjene infuzije poput eritema i boli.
English: HyQvia is used in patients with a weak immune system, who do not have enough antibodies in their blood and tend to get frequent infections.
Croatian: HyQvia se koristi kod bolesnika sa slabim imunološkim sustavom, koji nemaju dovoljno protutijela u krvi i skloni su čestim infekcijama.
English: 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).
Croatian: Učinci protutijela na komponentu rekombinantne ljudske hijaluronidaze lijeka HyQvia na ljudski embrij ili na razvoj fetusa u ljudi trenutno nisu poznati (vidjeti dio 5.3).
English: 1.4 (1.2 to 1.4)
Croatian: 1,4 (1,2 do 1,4)
English: Check for proper needle placement before starting the infusion if instructed by your healthcare professional.
Croatian: Provjerite je li igla ispravno postavljena prije početka infuzije ako Vas je tako uputio zdravstveni radnik.
English: The dose of HyQvia was based on the previous treatment with intravenous IG 10% (320 to 1,000 mg/kg body weight /4 weeks) and was individually adapted, ensuring adequate IgG levels throughout the study.
Croatian: Doza lijeka HyQvia temeljila se na prethodnom liječenju intravenskim IG-om 10% (od 320 do 1000 mg po kg tjelesne težine tijekom 4 tjedna) i bila je prilagođena pojedincu, čime su osigurane primjerene razine IgG-a tijekom ispitivanja.
English: 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.
Croatian: Vaš liječnik ili medicinska sestra prvo će Vam dati infuziju lijeka HyQvia polako i pažljivo Vas nadzirati tijekom cijelog trajanja prvih infuzija kako bi odmah uočili i liječili alergijsku reakciju, ako do nje dođe.
English: Name and address of the manufacturers of the biological active substance(s)
Croatian: Nazivi i adrese proizvođača biološke(ih) djelatne(ih) tvari
English: • Throw away any unused product in the vial and the disposable supplies as recommended by your healthcare professional.
Croatian: • Bacite svaki neiskorišteni lijek u bočici i materijal za jednokratnu uporabu prema preporuci Vašeg zdravstvenog radnika.
English: If you forget to use HyQvia
Croatian: Ako ste zaboravili primijeniti lijek HyQvia
English: Immunoglobulin products contain antibodies to blood groups (e.g A, B, D) which may act as haemolysins.
Croatian: Imunoglobulini mogu sadržavati protutijela na krvne grupe (npr. A, B, D) koja mogu reagirati kao hemolizini.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza „Rok valjanosti“ ili ”EXP”.
English: What HyQvia is
Croatian: Što je HyQvia
English: Certain side effects, such as headache, chills, or body aches, may be reduced by slowing the infusion rate.
Croatian: Neke nuspojave, kao što su glavobolja, zimica, ili bolovi u tijelu, mogu se smanjiti usporavanjem brzine infuzije.
English: After opening, dispose of any unused solutions in the vials.
Croatian: Nakon otvaranja, neiskorištene otopine u bočicama valja zbrinuti.
English: 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.
Croatian: Kliničko iskustvo s imunoglobulinima upućuje na to da ne treba očekivati štetne učinke na tijek trudnoće niti na fetus ili novorođenče.
English: Do not mix the components of HyQvia prior to administration.
Croatian: Nemojte miješati sastojke lijeka HyQvia prije primjene.
English: What you need to know before you use HyQvia
Croatian: Što morate znati prije nego počnete primjenjivati lijek HyQvia
English: The table presented below is according to the MedDRA System Organ Classification (SOC and Preferred Term Level).
Croatian: Tablica u nastavku u skladu je s klasifikacijom organskih sustava prema MedDRA-i (organski sustav i razina preporučenog pojma).
English: Known systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase.
Croatian: Poznata sistemska preosjetljivost na hijaluronidazu ili rekombinantnu ljudsku hijaluronidazu.
English: Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma.
Croatian: Normalni ljudski imunoglobulin i ljudski serumski albumin (stabilizator rekombinantne ljudske hijaluronidaze) dobivaju se iz ljudske plazme.
English: Severe renal adverse reactions have been reported in patients receiving immunoglobulin intravenous treatment, particularly those products containing sucrose (HyQvia does not contain sucrose).
Croatian: Prijavljene su teške bubrežne nuspojave kod bolesnika koji su primali intravensku terapiju imunoglobulinom, naročito lijekove koji sadrže saharozu (HyQvia ne sadrži saharozu).
English: • If known anaphylactic or severe hypersensitivity to human immunoglobulin exists, it should be noted in the patient records.
Croatian: • Ako je kod bolesnika poznata anafilaktička reakcija ili teška preosjetljivost na ljudski imunoglobulin, mora biti zabilježena u bolesnikov karton.
English: • Allow refrigerated product to come to room temperature before use.
Croatian: • Pričekajte da lijek iz hladnjaka postigne sobnu temperaturu prije upotrebe.
English: Development of non-neutralizing antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies.
Croatian: Razvoj ne-neutralizirajućih protutijela na komponentu rekombinantne ljudske hijalurodinaze prijavljen je u bolesnika koji su primali lijek HyQvia u kliničkim ispitivanjima.
English: How HyQvia works
Croatian: Kako HyQvia djeluje
English: o If either liquid is cloudy or has particles, do not use.
Croatian: ο Ako je bilo koja od tekućina zamućena ili sadrži čestice, nemojte je primijeniti.
English: Patients should be informed about first symptoms which encompass severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.
Croatian: Bolesnike treba informirati o prvim simptomima koji obuhvaćaju tešku glavobolju, ukočenost vrata, omamljenost, vrućicu, fotofobiju, mučninu i povraćanje.
English: Patients should be sufficiently hydrated before use of immunoglobulins.
Croatian: Bolesnici se trebaju dostatno hidrirati prije primjene imunoglobulina.
English: Adequate doses of human normal immunoglobulin may restore abnormally low IgG levels to the normal range.
Croatian: Odgovarajuće doze normalnog ljudskog imunoglobulina mogu vratiti abnormalno niske vrijednosti IgG-a u normalni raspon.
English: What HyQvia contains
Croatian: Što HyQvia sadrži
English: • 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.
Croatian: • Ako koristite pumpu, pripremite pumpu za primjenu infuzije rekombinantne ljudske hijaluronidaze početnom brzinom po mjestu primjene infuzije od 60 do 120 ml u satu, a ubrzajte ako to podnosite.
English: No temporal association between adverse reactions and the presence of anti-rHuPH20 antibodies could be demonstrated.
Croatian: Nije dokazana vremenska povezanost između nuspojava i prisutnosti protutijela anti-rHuPH20.
English: Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected.
Croatian: Prema kliničkom iskustvu s primjenom imunoglobulina ne treba očekivati štetne učinke IG-a 10% na plodnost.
English: No adverse effects on fertility were observed in mice, rabbits and cynomolgus monkeys exposed to antibodies that bind to recombinant human hyaluronidase and species-specific hyaluronidase.
Croatian: Nisu primijećeni štetni učinici na plodnost u miševa, kunića i makaki majmuna izloženih protutijelima koja se vežu s rekombinantnom ljudskom hijaluronidazom i hijaluronidazom specifičnom za vrstu.
English: The recombinant human hyaluronidase is a protein that makes it easier for the immunoglobulins to be infused (dripped) under the skin and to reach your blood system.
Croatian: Rekombinantna ljudska hijaluronidaza je protein koji olakšava infuziju (drip) imunoglobulina pod kožu i dostizanje Vašeg krvotoka.
English: Do not use vented vial access devices to remove recombinant human hyaluronidase from vials.
Croatian: Nemojte koristiti ventilne naprave za pristup bočici za vađenje rekombinantne ljudske hijaluronidaze iz bočica.
English: 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.
Croatian: Bolesnike treba informirati o prvim simptomima tromboembolijskih događaja uključujući nedostatak zraka, bol i oticanje uda, žarišne neurološke deficite i bol u prsima te ih treba savjetovati da se hitno jave svome liječniku ako se pojave ti simptomi.
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Croatian: Normalni ljudski imunoglobulin sadrži protutijela IgG prisutna u normalnoj populaciji.
English: 90.52 (83.8 to 9)
Croatian: 90,52 (83,8 do 98,4)
English: ► Please tell your vaccinating doctor or nurse about your treatment with HyQvia.
Croatian: Molimo obavijestite svog liječnika ili medicinsku sestru prije cijepljenja o Vašoj terapiji lijekom HyQvia.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Croatian: Pri proizvodnji lijekova od ljudske krvi ili plazme poduzimaju se određene mjere za sprječavanje prelaska infekcija na bolesnike.
English: One ml contains: Human normal immunoglobulin.
Croatian: Jedan ml sadrži: Normalni ljudski imunoglobulin.
English: Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Croatian: Imunoglobulini se izlučuju u mlijeko i mogu pridonijeti zaštiti novorođenčeta od patogena koji se unose putem sluznica.
English: 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.
Croatian: Mora se primijeniti cijeli sadržaj bočice rekombinantne ljudske hijaluronidaze, bez obzira na to je li primijenjen cijeli sadržaj bočice IG-a 10%.
English: The other ingredients are sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid (EDTA) disodium, calcium chloride and water for injections (see also section 2, “HyQvia contains sodium”).
Croatian: Drugi sastojci su natrijev klorid, natrijev fosfat, ljudski albumin, dinatrijeva sol etilendiamintetraoctene kiseline (EDTA), kalcijev klorid i voda za injekcije (vidjeti također dio 2, ”HyQvia sadrži natrij”).
English: In the clinical study with HyQvia, no differences in the plasma IgG trough levels were observed between adult and paediatric patients.
Croatian: U kliničkom ispitivanju o primjeni lijeka HyQvia nisu opažene razlike u najnižoj koncentraciji IgG-a u plazmi između odraslih i pedijatrijskih bolesnika.
English: Only two instances of local adverse reactions were severe, infusion site pain and infusion site swelling.
Croatian: Samo dva slučaja lokalnih nuspojava bila su teška, bol na mjestima primjene infuzije i oticanje mjesta primjene infuzije.
English: Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis.
Croatian: Primatelje pripravaka imunoglobulina potrebno je promatrati kako bi se uočili klinički znakovi i simptomi hemolize.
English: 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.
Croatian: Dva sastojka lijeka moraju se primijeniti uzastopno kroz istu iglu, prvo rekombinantna ljudska hijaluronidaza, a zatim IG 10%, kao što je opisano u nastavku.
English: 93.9 (89.1 to 102.1)
Croatian: 93,9 (89,1 do 102,1)
English: 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.
Croatian: 15. Primijenite normalni ljudski imunoglobulin 10%: Nakon primjene cijelog sadržaja manje štrcaljke (rekombinantne ljudske hijaluronidaze), odvojite štrcaljku od spojnika kompleta supkutane igle.
English: 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.
Croatian: Dobit ćete upute o: - tehnikama infuzije bez mikroba (aseptičke); - uporabi infuzijske pumpe ili automatske štrcaljke (po potrebi); - vođenju dnevnika terapije; - mjerama koje treba poduzeti u slučaju teških nuspojava.
English: The dose required to achieve a trough level of 6 g/l is of the order of 0.4-0.8 g/kg body weight per month.
Croatian: Da bi se postigla najniža koncentracija od 6 g/l, potrebna je doza od 0,4-0,8 g/kg tjelesne težine na mjesec.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A (HAV) and parvovirus B19 viruses.
Croatian: Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom kao što su virus humane imunodeficijencije (HIV), virus hepatitisa B (HBV) i virus hepatitisa C (HCV) te za viruse bez ovojnice kao što su virus hepatitisa A (HAV) i parvovirus B19.
English: Very common side effects (may affect more than 1 in 10 infusions):
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 infuzija):
English: The recombinant human hyaluronidase of HyQvia contains small amounts (4.03 mg per ml) of sodium.
Croatian: Rekombinantna ljudska hijaluronidaza lijeka HyQvia sadrži male količine (4,03 mg po ml) natrija.
English: • Gently press a small piece of gauze over the needle site and cover with a protective dressing.
Croatian: • Lagano pritisnite komadić gaze preko mjesta uboda igle i prekrijte zaštitnom oblogom.
English: They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution.
Croatian: Mogu se osobito javiti u bolesnika s protutijelima na IgA koje treba liječiti uz naročiti oprez.
English: Marketing Authorisation Holder: Baxalta Innovations GmbH Industriestrasse 67
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Baxalta Innovations GmbH Industriestrasse 67
English: You may experience a sudden fall in blood pressure and, in isolated cases, anaphylactic shock.
Croatian: Kod Vas bi se mogao pojaviti nagli pad krvnog tlaka i, u pojedinim slučajevima, anafilaktički šok.
English: Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.
Croatian: Preosjetljivost na ljudske imunoglobuline, posebice treba istaknuti vrlo rijetke slučajeve deficijencije IgA u kojima bolesnik ima razvijena protutijela protiv IgA.
English: From post-marketing data no clear correlation of AMS to higher doses was observed.
Croatian: Iz podataka prikupljenih nakon stavljanja lijeka u promet nije utvrđena jasna korelacija između sindroma aseptičkog meningitisa i viših doza.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: There was no increase in incidence or severity of adverse reactions in patients who developed antibodies to recombinant human hyaluronidase.
Croatian: Nije bilo porasta u incidenciji ili težini nuspojava u bolesnika koji su razvili protutijela na rekombinantnu ljudsku hijaluronidazu.
English: • Insert the tip of the needle/non-vented transfer device into the center of the vial stopper and push straight downward.
Croatian: • Stavite vrh igle/neventilirane naprave za prijenos u središte čepa na bočici i gurnite ga ravno prema dolje.
English: Human normal immunoglobulin 10%
Croatian: Normalni ljudski imunoglobulin 10%
English: Each vial of IG 10% is supplied with the appropriate corresponding quantity of recombinant human hyaluronidase as stated in the table below.
Croatian: Svaka bočica IG-a 10% dolazi s prikladnom odgovarajućom količinom rekombinantne ljudske hijaluronidaze kao što je navedeno u tablici u nastavku.
English: 45.3 (41.0 to 60.2)
Croatian: 45,3 (41,0 do 60,2)
English: The IG 10% component contains trace amounts of sodium.
Croatian: Sastojak IG 10% sadrži natrij u tragovima.
English: 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.
Croatian: Alergijske reakcije poput naglog pada krvnog tlaka ili anafilaktičkog šoka (nagli pad krvnog tlaka s drugim simptomima poput oticanja grla, otežanog disanja i kožnog osipa) rijetke su, ali se mogu povremeno javiti, čak i ako prethodno niste imali problema sa sličnim terapijama.
English: 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.
Croatian: Ako postoji bilo kakva sumnja na mogućnost alergijskih reakcija ili reakcija sličnih anafilaktičkoj nakon primjene rekombinantne ljudske hijaluronidaze, potrebno je odmah prekinuti davanje infuzije i, po potrebi, primijeniti standardno liječenje.
English: 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).
Croatian: Bočica s normalnim ljudskim imunoglobulinom (IG 10%) 25, 50, 100, 200 ili 300 ml otopine u bočici (staklo tipa I) s čepom (bromobutilna guma).
English: See image for infusion site locations.
Croatian: Vidjeti sliku za predviđena mjesta primjene infuzije.
English: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
Croatian: Rijetko, normalni ljudski imunoglobulin može uzrokovati pad krvnog tlaka uz anafilaktičku reakciju, čak i kod bolesnika koji su ranije dobro podnosili liječenje normalnim ljudskim imunoglobulinom.
English: - if you are allergic to immunoglobulins, hyaluronidase, recombinant hyaluronidase or any of the other ingredients of this medicine (listed in section 6, “Contents of the pack and other information”).
Croatian: - ako ste alergični na imunoglobuline, hijaluronidazu, rekombinantnu ljudsku hijaluronidazu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6. ”Sadržaj pakiranja i druge informacije”); - ako imate protutijela protiv imunoglobulina A (IgA) u krvi.
English: Information on the source material of HyQvia
Croatian: Informacije o izvornom materijalu lijeka HyQvia
English: 10.4 (9.4 to 11.2)
Croatian: 10,4 (9,4 do 11,2)