FrancophonIA/ELRC3.0 huggingface dataset:
English: Invert the system (the vial with the reconstituted solution has to be on top).
Croatian: Preokrenite sustav (tako da bočica s rekonstituiranom otopinom bude na vrhu).
English: ADVATE has no influence on the ability to drive and use machines.
Croatian: ADVATE ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The solvent vial has a blue stripe.
Croatian: Bočica s otapalom ima plavu traku.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) potentially life-threatening reactions (anaphylaxis) and other allergic reactions (hypersensitivity), general disorders (tiredness, lack of energy).
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) potencijalno životno ugrožavajuće reakcije (anafilaksija) i ostale alergijske reakcije (preosjetljivost), opći poremećaji (umor, nedostatak energije).
English: The product contains traces of mouse and hamster proteins.
Croatian: Ovaj lijek sadrži proteine miša i hrčka u tragovima.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doziranje i trajanje nadomjesne terapije ovise o težini nedostatka faktora VIII, mjestu te opsegu krvarenja kao i o kliničkom stanju bolesnika.
English: Other medicines and ADVATE Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako primjenjujete ili ste nedavno primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Time (h)
Croatian: Srednje vrijeme zadržavanja (h)
English: What you need to know before you use ADVATE
Croatian: Što morate znati prije nego počnete primjenjivati ADVATE
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII.
Croatian: Farmakoterapijska skupina: antihemoragici, koagulacijski faktor krvi VIII.
English: Driving and using machines ADVATE has no influence on your ability to drive or to use machines.
Croatian: Upravljanje vozilima i strojevima ADVATE nema utjecaja na sposobnost upravljanja vozilima ili strojevima.
English: Frequency of doses (hours)/duration of therapy (days)
Croatian: Učestalost doziranja (sati)/trajanje terapije (dani)
English: The ADRs that occurred in the highest frequency were development of neutralising antibodies to factor VIII (inhibitors), headache and fever.
Croatian: Nuspojave koje su se najčešće javile bile su stvaranje neutralizirajućih antitijela na faktor VIII (inhibitora), glavobolja i vrućica.
English: Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in ADRs were noted in the clinical studies.
Croatian: Osim razvijanja inhibitora u prethodno neliječenih pedijatrijskih bolesnika (PUPs - previously untreated paediatric patients) i komplikacija vezanih za kateter, tijekom kliničkih ispitivanja nisu uočene nikakve razlike u nuspojavama vezanim za dob.
English: Paediatric population: The listed warnings and precautions apply to both adults and children.
Croatian: Pedijatrijska populacija Navedena upozorenja i mjere opreza isti su u odraslih kao i za djecu.
English: C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Inhibitors are blocking antibodies against factor VIII that reduce the efficacy of ADVATE to prevent or control bleeding.
Croatian: Inhibitori su antitijela koja blokiraju faktor VIII i time smanjuju djelotvornost lijeka ADVATE u prevenciji ili kontroli krvarenja.
English: Factor VIII is necessary for the blood to form clots and stop bleedings.
Croatian: Faktor VIII je nužan u krvi kako bi se stvorio ugrušak i zaustavilo krvarenje.
English: Therefore, caution is advised during injection of ADVATE reconstituted in 2 ml, especially in children.
Croatian: Stoga se preporučuje oprez tijekom injiciranja lijeka ADVATE pripremljenog s 2 ml, naročito u djece.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su poredane prema padajućem nizu ozbiljnosti.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Croatian: Zbog rijetke pojave hemofilije A u žena, ne postoje iskustva s primjenom faktora VIII tijekom trudnoće i dojenja.
English: Octocog alfa is a glycoprotein consisting of 2332 amino acids with an approximate molecular mass of 280 kD.
Croatian: Oktokog alfa je glikoprotein koji se sastoji od 2332 aminokiseline s približnom molekularnom masom od 280 kD.
English: Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.
Croatian: Ispitivanja na inhibitor faktora VIII bila su negativna nakon završetka kontinuirane infuzije kao i po završetku studije.
English: Uncommon side effects (may affect up to 1 in 100 people) Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment)), dizziness, flu, fainting, abnormal heartbeat, red itchy bumps on the skin, chest discomfort, injection site bruise, injection site reaction, itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, sore throat, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, reduced percentage of red blood cells, increase in a type of white blood cells (monocytes), and pain in the upper abdomen or lower chest.
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) Inhibitori faktora VIII (za bolesnike koji su ranije primali terapiju s faktorom VIII (više od 150 dana liječenja)), omaglica, gripa, nesvjestica, neuobičajeni otkucaji srca, crvene izbočine na koži koje svrbe, nelagoda u prsima, modrica na mjestu injekcije, reakcija na mjestu injekcije, svrbež, pojačano znojenje, neobičan okus u ustima, navale vrućine, migrena, oštećenje pamćenja, zimica, proljev, mučnina, povraćanje, nedostatak zraka, grlobolja, infekcija limfnih žila, bljedoća kože, upala oka, osip, prekomjerno znojenje, naticanje stopala i nogu, smanjen postotak crvenih krvnih stanica, porast u broju jedne vrste bijelih krvnih stanica (monocita) te bol u gornjem dijelu trbuha ili donjem dijelu prsišta.
English: You or someone else might also administer ADVATE as an injection, but only after receiving adequate training.
Croatian: Injekciju lijeka ADVATE Vam također može dati i netko drugi pa i Vi sami sebi, ali tek nakon odgovarajućeg osposobljavanja.
English: There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADVATE.
Croatian: Postoji opasnost, koja je rijetka, da u Vas nastupi anafilaktička reakcija (teška, iznenadna alergijska reakcija) na ADVATE.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Croatian: Ciljna razina faktora VIII ovisiti će o težini i mjestu krvarenja.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate Factor VIII levels.
Croatian: Liječnik će napraviti potrebna laboratorijska ispitivanja kako bi provjerio je li razina faktora VIII u Vas zadovoljavajuća.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IUs (relative to the international standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se ili u postotku (u odnosu na normalnu ljudsku plazmu) ili u IU (u odnosu na međunarodni standard za faktor VIII u plazmi).
English: d) Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Croatian: Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients), PUPs = prethodno neliječeni bolesnici (engl. previously-untreated patients).
English: ADVATE is usually injected into a vein (intravenously) by your doctor or nurse.
Croatian: ADVATE će Vam obično dati liječnik ili medicinska sestra injiciranjem u venu (intravenski).
English: No interaction studies have been performed with ADVATE.
Croatian: S lijekom ADVATE nisu provedena ispitivanja interakcija.
English: Place the vials on a flat clean surface.
Croatian: Stavite bočice na ravnu i čistu površinu.
English: Place the ADVATE on a flat surface with the solvent vial on top (Fig. 1).
Croatian: Postavite ADVATE na ravnu površinu s bočicom otapala na vrhu (slika 1).
English: ADVATE must not be mixed with other medicinal products or solvents.
Croatian: ADVATE se ne smije miješati s drugim lijekovima ili otapalima.
English: Use in children and adolescents (from 0 to 18 years of age) For the treatment of bleeding the dosing in children does not differ from adult patients.
Croatian: Primjena u djece i adolescenata (u dobi od 0 do 18 godina) Doziranje kod liječenja krvarenja u djece ne razlikuje se od odraslih bolesnika.
English: If you stop using ADVATE Do not stop using ADVATE without consulting your doctor.
Croatian: Ako prestanete primjenjivati ADVATE Ne smijete prekinuti primjenjivati ADVATE bez prethodnog odobrenja Vašeg liječnika.
English: Each pack also contains a device for reconstitution (BAXJECT II).
Croatian: Svako pakiranje također sadrži uređaj za pripremu otopine (BAXJECT II).
English: When infused into a haemophilia patient, octocog alfa binds to endogenous von Willebrand Factor in the patient's circulation.
Croatian: Nakon infuzije bolesniku s hemofilijom, oktokog alfa se veže na endogeni von Willebrandov faktor u krvnoj cirkulaciji bolesnika.
English: Discard any unused solution appropriately.
Croatian: Neiskorištenu otopinu valja odgovarajuće zbrinuti.
English: If central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Croatian: Ako je neophodan centralni venski kateter (CVK), treba uzeti u obzir komplikacije vezane uz centralni venski kateter koje uključuju lokalnu infekciju, bakterijemiju i trombozu na mjestu katetera.
English: Data on Immune Tolerance Induction (ITI) in patients with inhibitors have been collected.
Croatian: Prikupljeni su podaci o liječenju metodom imunotolerancije (ITI - Immune Tolerance Induction) u bolesnika s inhibitorima.
English: The dose and frequency of administration should be adapted to the clinical response in the individual case.
Croatian: Dozu i učestalost primjene potrebno je prilagoditi kliničkom odgovoru svakog bolesnika ponaosob.
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Croatian: Tablica 1 Vodič za doziranje kod krvarenja i u kirurgiji Stupanj krvarenja/vrsta kirurškog zahvata
English: Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids.
Croatian: Oktokog alfa (ljudski koagulacijski faktor VIII (rDNK)) je pročišćeni protein koji ima 2332 aminokiselina.
English: A local tolerance study in rabbits showed that ADVATE reconstituted with 2 ml of sterilised water for injections is well tolerated after intravenous administration.
Croatian: Ispitivanje lokalne tolerancije provedene na kunićima pokazalo je da se ADVATE pripremljen s 2 ml sterilizirane vode za injekcije dobro tolerira nakon intravenske primjene.
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Croatian: Stoga se preporučuje pažljivo pratiti sve bolesnike na pojavu inhibitora nakon svakog prelaska s jednog lijeka na drugi.
English: Treatment with ADVATE will be started by a doctor who is experienced in the care of patients with haemophilia A.
Croatian: Liječenje lijekom ADVATE će započeti liječnik s iskustvom u liječenju bolesnika s hemofilijom A.
English: For on demand treatment dosing in paediatric patients (0 to 18 years of age) does not differ from adult patients.
Croatian: Doziranje kod liječenja kada se pojavi krvarenje u pedijatrijskih bolesnika (od 0 do 18 godina) ne razlikuje se od odraslih bolesnika.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 March 2004
Croatian: Datum prvog odobrenja: 2. ožujka 2004.
English: In this case, this medicine expires at the end of this 6 month period or the expiration date printed on the blister, whichever is earlier.
Croatian: U tom slučaju, ovaj lijek ističe na kraju tog šestomjesečnog razdoblja ili na datum isteka roka valjanosti otisnutom na blisteru, štogod prije nastupi.
English: The following table 2 provides the frequency of adverse drug reactions in clinical trials and from spontaneous reporting.
Croatian: Sljedeća tablica 2 prikazuje učestalost nuspojava tijekom kliničkih ispitivanja i tijekom spontanih prijava.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ADVATE in all subsets of the paediatric population in haemophilia A (congenital factor VIII deficiency) in "Immune Tolerance Induction (ITI) in patients with haemophilia A (congenital factor VIII deficiency) who have developed inhibitors to factor VIII" and "treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)".
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka ADVATE u svim podskupinama pedijatrijske populacije s hemofilijom A (urođeni nedostatak faktora VIII) kod "liječenja metodom imunotolerancije (ITI - Immune Tolerance Induction) u bolesnika s hemofilijom A (urođeni nedostatak faktora VIII) koji su razvili inhibitore na faktor VIII" te kod "liječenja i profilaksi krvarenja u bolesnika s hemofilijom A (urođeni nedostatak faktora VIII)". (za informacije o pedijatrijskoj primjeni vidjeti dio 4.2).
English: Dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal) x 0.5
Croatian: Doza (IU) = tjelesna težina (kg) x željeni porast faktora VIII (% od normalne vrijednosti) x 0,5
English: This product is for single use only.
Croatian: Ovaj lijek je namijenjen samo za jednokratnu uporabu.
English: The number of units of factor VIII is expressed in International Units (IU), which are related to the WHO standard for factor VIII products.
Croatian: Broj jedinica faktora VIII izražava se u međunarodnim jedinicama (IU), koje su u skladu s važećim SZO standardom za preparate faktora VIII.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcija na mjestu zahvata a)
English: Related to central venous access devices (CVAD) catheter-related infection, systemic infection and local blood clot at the catheter site.
Croatian: Nuspojave vezane uz centralni venski kateter infekcije povezane s kateterom, sustavna infekcija i lokalni krvni ugrušak na mjestu postavljanja katetera.
English: Categories of these analyses for infants (1 month to <2 years of age), children (2 to <5 years of age), older children (5 to <12 years of age), adolescents (12 to <18 years of age), and adults (18 years of age and older) were used to summarize PK parameters, where age was defined as age at time of PK infusion.
Croatian: Kategorije navedenih analiza za dojenčad (u dobi od 1 mjeseca do <2 godine), djecu (u dobi od 2 do <5 godina), stariju djecu (u dobi od 5 do <12 godina), adolescente (u dobi od 12 do <18 godina) i odrasle (u dobi od 18 godina i starije) korištene su za sažimanje farmakokinetičkih parametara, a dob je definirana kao dob u trenutku farmakokinetičke infuzije.
English: Verify that the solvent transfer is complete.
Croatian: Provjerite da je prijenos otapala potpun.
English: • Do not use if the lid is not completely sealed on the blister
Croatian: • Ne upotrebljavajte ako pokrov na blisteru nije u potpunosti zatvoren.
English: Prevention of bleeding
Croatian: Sprječavanje krvarenja
English: Adolescents (n=33)
Croatian: Adolescenti (n=33)
English: For ADVATE reconstituted with 2 ml sterilised water for injections, misapplication (intra-arterially or paravenously) may lead to mild, short term injection site reactions, such as bruising and erythema.
Croatian: Za ADVATE pripremljen s 2 ml sterilizirane vode za injekcije, kriva primjena (intraarterijska ili paravenska) može izazvati na mjestu uboda blage, kratkotrajne reakcije, poput modrica i eritema.
English: Adults (n=109)
Croatian: Odrasli (n=109)
English: Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Croatian: Primijećeni su slučajevi ponovne pojave inhibitora (nizak titar) nakon prelaska s jednog lijeka koji sadrži faktor VIII na drugi u prethodno liječenih bolesnika s više od 100 dana izloženosti, koji su u prijašnjoj povijesti bolesti imali razvoj inhibitora.
English: A total of 195 subjects with severe haemophilia A (baseline factor VIII < 1%) provided PK parameters that were included in the Per-Protocol PK analysis set.
Croatian: Ukupno 195 ispitanika s teškom hemofilijom A (početna vrijednost faktora VIII <1%) dalo je farmakokinetičke parametre koji su uključeni u niz farmakokinetičkih analiza prema planu ispitivanja.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and with resuscitation support immediately available in case of anaphylaxis.
Croatian: Liječenje se mora započeti uz nadzor liječnika s iskustvom u liječenju hemofilije te uz neposrednu dostupnost sustava za reanimaciju u slučaju anafilaksije.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADVATE.
Croatian: Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući ADVATE.
English: Reconstitution with the BAXJECT II device - For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.
Croatian: Rekonstitucija pomoću uređaja BAXJECT II - Za rekonstituciju koristiti samo steriliziranu vodu za injekcije i uređaj za rekonstituciju koji se nalaze u pakiranju lijeka.
English: Uncommon (PTPs)d Very common (PUPs)
Croatian: manje često (PTPs) d vrlo često (PUPs) d
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava dizgeuzija
English: With one hand holding the ADVATE in the BAXJECT III system, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the ADVATE vial (Fig. 2).
Croatian: Jednom rukom držite ADVATE u sustavu BAXJECT III, drugom rukom čvrsto pritisnite bočicu otapala prema dolje sve dok u potpunosti ne potisnete sustav i dok otapalo ne teče u bočicu s lijekom ADVATE (slika 2).
English: If you inject more ADVATE than recommended, tell your doctor as soon as possible.
Croatian: Ako ste primijenili veću dozu lijeka ADVATE od preporučene, čim prije se obratite svom liječniku.
English: The following table 1 can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica 1 može koristiti kao vodič za doziranje kod krvarenja i u kirurgiji:
English: ADVATE is used for the treatment and prevention of bleeding in patients of all age groups with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Croatian: ADVATE se koristi za liječenje i prevenciju krvarenja u bolesnika svih dobnih skupina s hemofilijom A (nasljedni poremećaj krvarenja koji je prouzročen nedostatkom faktora VIII).
English: Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Croatian: Otvorite papirnati pokrov s pakiranja uređaja BAXJECT II, pazeći da pri tome ne dodirnete unutrašnjost (slika a).
English: Open the ADVATE package by peeling away the lid.
Croatian: Otvorite pakiranje lijeka ADVATE tako da odlijepite pokrov.
English: Solvent Sterilised water for injections
Croatian: Otapalo sterilizirana voda za injekcije
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i probadanje na mjestu infuzije, zimicu, crvenilo praćeno osjećajem vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsima, trnce, povraćanje, piskanje) uočene su rijetko, no u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: Misapplication (injection into the artery or outside the vein) should be avoided as mild, short term injection site reactions, such as bruising and redness, may occur.
Croatian: Treba izbjegavati krivu primjenu (injiciranje u arteriju ili izvan vene) jer na mjestu uboda mogu nastati blage, kratkotrajne reakcije, poput modrica i crvenila.
English: Detailed information on this medicine is available on the European Medicines Agency web site: 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: Very common side effects (may affect more than 1 in 10 people) Factor VIII inhibitors (for children not previously treated with Factor VIII medicines).
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) Inhibitori faktora VIII (za djecu koja ranije nisu bila liječena lijekovima faktora VIII).
English: Administration Use Aseptic Technique
Croatian: Primjena Treba koristiti aseptičku tehniku
English: Activated factor VIII acts as a Cofactor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X. Activated Factor X converts prothrombin to thrombin.
Croatian: Aktivirani faktor VIII djeluje kao kofaktor za aktivirani faktor IX, čime se pospješuje pretvorba faktora X u aktivirani faktor X.
English: The usual dose of octocog alfa is 20 to 40 IU per kg body weight, administered every 2 to 3 days.
Croatian: Uobičajena doza je između 20 i 40 IU oktokoga alfa po kilogramu tjelesne težine, svakih 2 do 3 dana.
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Croatian: Teški simptomi koji uključuju poteškoće u disanju te (skoro) nesvjesticu zahtijevaju hitnu medicinsku pomoć.
English: Related to surgery catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative bruise.
Croatian: Nuspojave vezane uz kirurški zahvat infekcije povezane s kateterom, smanjeni broj crvenih krvnih stanica, naticanje ruku i nogu i zglobova, produljeno krvarenje nakon uklanjanja drena, sniženje razine faktora VIII i postoperativna modrica.
English: More extensive haemarthrosis, muscle bleeding or haematoma.
Croatian: Jače krvarenje u zglobove, mišićno krvarenje ili hematom.
English: During the course of treatment, appropriate determination of plasma factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Croatian: Tijekom ciklusa liječenja, savjetuje se redovito određivanje razine faktora VIII u plazmi, kako bi se mogla prilagoditi doza i učestalost ponavljanja injekcija.
English: ADVATE contains sodium
Croatian: ADVATE sadrži natrij