FrancophonIA/ELRC3.0 huggingface dataset:
English: From a microbiological point of view, the medicine should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba odmah primijeniti.
English: The steady state volume of distribution was approximately 10% of the body weight.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže bio je oko 10% tjelesne težine.
English: To be administered as a 60-minute intravenous infusion.
Croatian: Primijeniti kao 60-minutnu intravensku infuziju.
English: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 USA
Croatian: Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 SAD
English: The required vials are removed from the refrigerator.
Croatian: Bočice potrebne za pripremu izvadite iz hladnjaka.
English: Your doctor will monitor your response to treatment and may change your dose (up or down) over time.
Croatian: Liječnik će pratiti Vaš odgovor na liječenje te može tijekom vremena promijeniti Vašu dozu (na veću ili manju).
English: *An enzyme unit is defined as the amount of enzyme that is required to convert one micromole of p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at 37ºC.
Croatian: * Enzimska jedinica definirana je kao količina enzima koja je potrebna da bi se jedan mikromol p-nitrofenil β-D-glukopiranozida pretvorio u p-nitrofenol po minuti na 37 ºC.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane prema opadanju ozbiljnosti.
English: Frequency is defined as very common (1/10), common (1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Croatian: Učestalost je definirana kao vrlo česta (1/10), česta (1/100 i <1/10) i manje česta (1/1000 i <1/100).
English: In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment.
Croatian: Kod prethodno neliječenih bolesnika, većina reakcija povezanih s infuzijom dogodila se tijekom prvih 6 mjeseci liječenja.
English: The only adverse reaction leading to discontinuation of treatment was an infusion-related reaction.
Croatian: Jedina nuspojava koja je dovela do prekida liječenja bila je reakcija povezana s infuzijom.
English: After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.
Croatian: Nakon pripreme, liječnik ili medicinska sestra će Vam dati lijek kapanjem infuzije u venu (intravenskom infuzijom) u trajanju od 60 minuta.
English: • Requirements for home infusion (home condition, patient assessment, emergency treatment);
Croatian: • uvjeti za primjenu infuzije kod kuće (uvjeti kod kuće, procjena bolesnika, liječenje u hitnim situacijama);
English: In Studies 025EXT and 034, patients were offered home therapy.
Croatian: U ispitivanjima 025EXT i 034, bolesnicima se nudila terapija kod kuće.
English: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 USA
Croatian: Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 SAD
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials.
Croatian: Izračunati volumen lijeka izvlači se iz odgovarajućeg broja bočica.
English: Cartons with 1, 5 or 25 vials.
Croatian: Kutije s 1, 5 ili 25 bočica.
English: However a few patients experienced an allergic skin reaction which may affect up to 1 in 10 people (common) such as severe rash or itching.
Croatian: Međutim kod nekoliko bolesnika pojavile su se alergijske kožne reakcije koje se mogu javiti u do 1 na 10 osoba (često) poput teškog osipa ili svrbeža.
English: The MAH shall ensure that in each Member State where VPRIV is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use VPRIV have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja će u svakoj zemlji članici u kojoj će VPRIV biti stavljen u promet, svim zdravstvenim radnicima i bolesnicima/njegovateljima za koje se pretpostavlja da će propisivati, izdavati ili primjenjivati VPRIV osigurati pristup/dostavu sljedećeg edukacijskog paketa:
English: Do not use this medicine after the expiry date which is stated on the carton and label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i naljepnici iza oznake „EXP“.
English: The majority of hypersensitivity reactions usually occur up to 12 hours post infusion.
Croatian: Većina reakcija preosjetljivosti događa se do 12 sati nakon infuzije.
English: 20 ml glass vial containing a white to off-white powder.
Croatian: Staklena bočica od 20 ml koja sadržava bijeli do gotovo bijeli prah.
English: Reconstituted and diluted solution for infusion:
Croatian: Pripremljena i razrijeđena otopina za infuziju:
English: Patients were between 4 and 71 years old at the time of first treatment with VPRIV, and included 46 male and 48 female patients.
Croatian: Bolesnici su u vrijeme prve terapije VPRIV-om bili u dobi od 4 do 71 godine te je bilo 46 muškaraca i 48 žena.
English: Pack sizes of 1, 5 and 25 vials.
Croatian: Veličine pakiranja od 1, 5 i 25 bočica.
English: Ten patients who completed Study 025 enrolled in an open-label extension study (025EXT), 8 of whom completed the study.
Croatian: Deset bolesnika koji su završili ispitivanje 025 bilo je uključeno u otvoreni produžetak ispitivanja (025EXT), te je njih 8 dovršilo ispitivanje.
English: In contrast, no significant change in femoral neck BMD was observed.
Croatian: Za razliku od toga, nije zapažena značajna promjena u BMD-u vrata bedrene kosti.
English: If you are tolerating your infusions well in the clinic, your doctor or nurse may administer your infusions at home.
Croatian: Ako dobro podnosite infuzije na klinici, liječnik ili medicinska sestra mogu Vam davati infuzije i kod kuće.
English: The safety profile in these patients was similar to that observed in other clinical trials.
Croatian: Profil sigurnosti je u tih bolesnika bio sličan onome zabilježenom u drugim kliničkim ispitivanjima.
English: The maximum dose of velaglucerase alfa in clinical studies was 60 Units/kg.
Croatian: Maksimalna doza velagluceraze alfa u kliničkim ispitivanjima bila je 60 jedinica/kg.
English: Patients were required to have a stable dose of imiglucerase for at least 6 months prior to study enrolment.
Croatian: Zahtijevalo se da bolesnici imaju stabilnu dozu imigluceraze kroz najmanje 6 mjeseci prije uključenja u ispitivanje.
English: The active substance of VPRIV is velaglucerase alfa, which is produced by gene activation technology in a human cell line.
Croatian: Djelatna tvar VPRIV-a je velagluceraza alfa, koja se proizvodi tehnologijom aktivacije gena u ljudskoj staničnoj liniji.
English: Therefore, it was not possible to evaluate the effect of antibody response on the pharmacokinetic profile of velaglucerase alfa.
Croatian: Stoga nije bilo moguće procijeniti učinak odgovora protutijela na farmakokinetički profil velagluceraze alfa.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB10.
Croatian: Farmakoterapijska skupina: ostali lijekovi za probavni sustav i metabolizam - enzimi, ATK oznaka: A16AB10.
English: The most serious adverse reactions in patients in clinical trials were hypersensitivity reactions.
Croatian: Najozbiljnije nuspojave kod bolesnika u kliničkim ispitivanjima bile su reakcije preosjetljivosti.
English: Investigations activated partial thromboplastin time prolonged, neutralizing antibody positive
Croatian: Pretrage produljeno aktivirano parcijalno tromboplastinsko vrijeme, pozitivna neutralizirajuća protutijela
English: Use in the age group 4 to 17 is supported by evidence from controlled studies in adults and paediatric [20 of 94 (21%)] patients.
Croatian: Primjena u dobnoj skupini od 4 do 17 godina podržana je dokazima iz kontroliranih ispitivanja na odraslim i pedijatrijskim bolesnicima [20 od 94 (21%)].
English: The infusion should be initiated within 24 hours from the time of reconstitution.
Croatian: Infuziju treba započeti unutar 24 sati od vremena rekonstitucije.
English: Most side effects occurred during the infusion or shortly after.
Croatian: Većina se nuspojava javila tijekom infuzije ili neposredno nakon toga.
English: Immune system disorders hypersensitivity reactions (includes dermatitis allergic and anaphylactic/anaphylactoid reactions)
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti (uključuju alergijski dermatitis i anafilaktičke/anafilaktoidne reakcije)
English: An IRR often appears as a hypersensitivity reaction.
Croatian: Reakcija povezana s infuzijom često izgleda kao reakcija preosjetljivosti.
English: The majority of these side effects were mild in intensity.
Croatian: Većina tih nuspojava bile su blagog intenziteta.
English: • Organisation of home infusion/preparation of infusion;
Croatian: • organizacija primjene infuzije kod kuće/priprema infuzije;
English: What VPRIV looks like and contents of the pack
Croatian: Kako VPRIV izgleda i sadržaj pakiranja
English: The European Medicines Agency has waived the obligation to submit the results of studies with VPRIV in all subsets of the paediatric population with type 2 Gaucher disease.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s VPRIV-om u svim podskupinama pedijatrijske populacije s Gaucherovom bolešću tipa 2.
English: The accumulation of glucocerebroside in the liver and spleen leads to organomegaly.
Croatian: Nakupljanje glukocerebrozida u jetri i slezeni dovodi do organomegalije.
English: Information is presented by system organ class and frequency according to MedDRA convention.
Croatian: Podaci su navedeni prema klasifikaciji organskih sustava i učestalosti u skladu s MedDRA konvencijom.
English: 57 patients were treatment-naïve.
Croatian: 57 bolesnika nije prethodno bilo liječeno.
English: There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease.
Croatian: Nije bilo očitih farmakokinetičkih razlika između muških i ženskih bolesnika s Gaucherovom bolešću tipa
English: It should not be shaken.
Croatian: Ne smije se tresti.
English: The Marketing Authorisation Holder (MAH) must agree on the content and format of the educational materials for use of VPRIV in home infusion, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Croatian: Nositelj odobrenja (MAH) mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskog materijala za primjenu infuzije lijeka VPRIV kod kuće, uključujući medije komunikacije, načine distribucije i druge aspekte programa.
English: Excipient with known effect: One vial contains 12.15 mg sodium.
Croatian: Pomoćna tvar s poznatim učinkom: Jedna bočica sadržava 12,15 mg natrija.
English: Twenty of the 94 patients (21%) who received velaglucerase alfa during clinical studies were in the paediatric and adolescent age range (4 to 17 years).
Croatian: Dvadeset od 94 bolesnika (21%) koji su primili velaglucerazu alfa tijekom kliničkih ispitivanja bili su u pedijatrijskom ili adolescentskom rasponu dobi (od 4 do 17 godina).
English: Uncommon side effects are: - blurry vision (may be associated with an infusion-related reaction) - vomiting
Croatian: Manje česte nuspojave su: - zamagljen vid (može biti povezano s reakcijom povezanom s infuzijom) - povraćanje
English: Must be administered through a 0.22 µm filter.
Croatian: Mora se primijeniti kroz filtar od 0,22 µm.
English: An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion.
Croatian: Reakcija povezana s infuzijom definirana je kao bilo koja nuspojava koja nastane unutar 24 sata od početka infuzije velagluceraze alfa.
English: Velaglucerase alfa is a glycoprotein.
Croatian: Velagluceraza alfa je glikoprotein.
English: To further evaluate the relationship, in cases of severe infusion-related reactions and in cases of lack or loss of effect patients should be tested for the presence of antibodies and the results reported to the company.
Croatian: Kako bi se dodatno procijenila povezanost, u slučajevima teških reakcija povezanih s infuzijom te u slučajevima gubitka ili smanjenja učinka lijeka, bolesnike treba testirati na prisutnost protutijela, a rezultate prijaviti tvrtki.
English: Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.
Croatian: Žene s Gaucherovom bolešću koje su trudne ili planiraju trudnoću trebaju porazgovarati sa svojim liječnikom prije primjene ovog lijeka.
English: The educational materials for the use of VPRIV in home infusion are aimed at providing guidance on how to manage risk of infusion-related reactions including allergic-type hypersensitivity reactions in a home setting.
Croatian: Edukacijski materijali za primjenu infuzije lijeka VPRIV kod kuće imaju za cilj pružiti upute za upravljanje rizikom od reakcija povezanih s infuzijom uključujući reakcije preosjetljivosti alergijskog tipa koje se pojavljuju kod kućne primjene.
English: A severe allergic reaction, with difficulty breathing, swelling of the face, lips, tongue or throat occured.
Croatian: Pojavila se i teška alergijska reakcija s otežanim disanjem, oticanjem lica, usnica, jezika ili grla.
English: Elderly patients may be treated within the same dose range (15 to 60 units/kg) as other adult patients.
Croatian: Stariji bolesnici mogu se liječiti u istom rasponu doze (od 15 do 60 jedinica/kg) kao drugi odrasli bolesnici.
English: Treatment should be approached with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa or other enzyme replacement therapy.
Croatian: Liječenju treba pristupiti s oprezom u bolesnika koji su pokazali simptome preosjetljivosti na velaglucerazu alfa ili drugu enzimsku nadomjesnu terapiju.
English: VPRIV should not be infused with other medicines in the same infusion as the compatibility in solution with other medicines has not been evaluated.
Croatian: VPRIV se ne smije davati u infuziji s drugim lijekovima jer kompatibilnost u otopini s drugim lijekovima nije ispitana.
English: • Manual for patients with Gaucher Disease who receive home infusion;
Croatian: • priručnik za bolesnike s Gaucherovom bolešću koji primaju infuzije kod kuće;
English: None of the subjects in the pharmacokinetic studies were positive for anti-velaglucerase alfa antibodies on the days of pharmacokinetic evaluation.
Croatian: Ni jedan od ispitanika u farmakokinetičkim ispitivanjima nije bio pozitivan na protutijela antivelagluceraza alfa na dane farmakokinetičke evaluacije.
English: Fertility Animal studies show no evidence of impaired fertility.
Croatian: Plodnost Ispitivanja na životinjama nisu pružila dokaz o poremećaju plodnosti.
English: What VPRIV is and what it is used for What you need to know before VPRIV is used How VPRIV is used
Croatian: Što je VPRIV i za što se koristi Što morate znati prije nego počnete primjenjivati VPRIV Kako primjenjivati VPRIV
English: Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.
Croatian: Obavijestite svog liječnika ako Vam se ranije pojavila reakcija povezana s infuzijom na drugu nadomjesnu enzimsku terapiju za Gaucherovu bolest.
English: Only 1 out of 163 patients assessed developed anti-velaglucerase alfa antibodies during the study.
Croatian: Samo je 1 od 163 bolesnika koji su bili ocjenjivani razvio anti-velagluceraza alfa protutijela tijekom ispitivanja.
English: In the clinical trials, one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa.
Croatian: U kliničkim ispitivanjima, jedan od 94 (1%) bolesnika razvio je protutijela IgG razreda na velaglucerazu alfa.
English: Prevention and Management of infusion related reactions including hypersensitivity reactions The management of infusion-related reactions should be based on the severity of the reaction, and include slowing the infusion rate, treatment with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
Croatian: Sprječavanje i zbrinjavanje reakcija povezanih s infuzijom, uključujući reakcije preosjetljivosti Zbrinjavanje reakcija povezanih s infuzijom treba se temeljiti na težini reakcije te uključivati usporavanje brzine infuzije, terapiju lijekovima poput antihistaminika, antipiretika i/ili kortikosteroida, i/ili prekid te ponovno uvođenje liječenja s duljim vremenom infuzije.
English: Velaglucerase alfa serum concentrations rose rapidly for the first 20 minutes of the 60-minute infusion before leveling off, and Cmax was typically attained between 40 and 60 minutes after the start of the infusion.
Croatian: Koncentracija velagluceraze alfa u serumu naglo je porasla u prvih 20 minuta 60-minutne infuzije prije početka pada, a Cmax se tipično postizao između 40 i 60 minuta nakon početka infuzije.
English: • About the disease, treatment and home infusion;
Croatian: • o bolesti, liječenju i primjeni infuzije kod kuće;
English: ** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
Croatian: **Proizvodena tehnologijom rekombinantne DNK u staničnoj liniji humanih fibroblasta HT-1080.
English: The build-up of this material causes the signs and symptoms found in Gaucher disease.
Croatian: Nakupljanje ove tvari dovodi do znakova i simptoma Gaucherove bolesti.
English: Caution should be exercised when prescribing to pregnant women.
Croatian: Treba biti oprezan prilikom propisivanja lijeka trudnicama.
English: There was no indication of significant improvements of the neurological manifestations of type 3 Gaucher disease except for one patient in this study.
Croatian: U tom ispitivanju nije bilo pokazatelja značajnih poboljšanja neuroloških manifestacija Gaucherove bolesti tipa 3, osim u jednog bolesnika.
English: • Emergency plan provided by the prescriber including who to call and what to do in the case of a serious hypersensitivity reaction.
Croatian: • plan postupanja u hitnim situacijama koji će sastaviti liječnik koji je lijek propisao, uz uključene informacije o tome kome se obratiti i što poduzeti u slučaju ozbiljne reakcije preosjetljivosti.
English: The high clearance of velaglucerase alfa from serum (mean 6.7 to 7.6 ml/min/kg) is consistent with the rapid uptake of velaglucerase alfa into macrophages via mannose receptors.
Croatian: Visoki klirens velagluceraze alfa iz seruma (srednja vrijednost od 6,7 do 7,6 ml/min/kg) u skladu je s brzim preuzimanjem velagluceraze alfa od makrofaga putem manoznih receptora.
English: What you need to know before VPRIV is used
Croatian: Što morate znati prije nego počnete primjenjivati VPRIV
English: A risk-benefit assessment is required for women with Gaucher disease who are considering pregnancy.
Croatian: Procjena rizika i koristi nužna je za žene s Gaucherovom bolesti koje planiraju trudnoću.
English: Talk to your doctor before VPRIV is used - If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects).
Croatian: Obratite se svom liječniku prije primjene VPRIV-a - Ako se liječite VPRIV-om, mogu Vam se pojaviti nuspojave tijekom ili nakon infuzije (pogledajte dio 4 za moguće nuspojave).
English: Velaglucerase alfa exhibited an approximately linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased approximately proportional to the dose over the dose range 15 to 60 Units/kg.
Croatian: Velagluceraza alfa pokazala je otprilike linearan (tj. prvog reda) farmakokinetički profil te su se Cmax i AUC povećavali otprilike proporcionalno dozi unutar raspona doza od 15 do 60 jedinica/kg.
English: Each 400 Units vial is reconstituted with 4.3 ml of sterile water for injections.
Croatian: Svaka bočica od 400 jedinica priprema se za primjenu s 4,3 ml sterilne vode za injekcije.
English: The Guide for Healthcare Professionals Treating Patients with Gaucher Disease should contain the following key elements:
Croatian: Vodič za zdravstvene radnike koji liječe bolesnike s Gaucherovom bolešću mora sadržavati sljedeće ključne elemente:
English: Table 2: Results at 24 months - Change from Baseline - Study 044 ITT Population Clinical Parameters
Croatian: Tablica 2: Rezultati nakon 24 mjeseca - promjena u odnosu na početnu vrijednostispitivanje 044 - ITT populacija
English: Some solution will remain in the vial:
Croatian: Dio će otopine ostati u bočici:
English: Skin and subcutaneous tissue disorders rash, urticaria, pruritus
Croatian: Poremećaji kože i potkožnog tkiva osip, urtikarija, pruritus
English: When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body.
Croatian: Kada ovaj enzim nedostaje ili ne funkcionira pravilno, u stanicama tijela se nakuplja tvar nazvana glukocerebrozid.
English: VPRIV may be given to children and adolescents (2 to 17 years of age) at the same dose and frequency as in adults.
Croatian: VPRIV se može davati djeci i adolescentima (u dobi od 2 do 17 godina) u istoj dozi i istom učestalosti kao kod odraslih.
English: Store in the refrigerator (2ºC - 8ºC).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Elderly (≥65 years old)
Croatian: Stariji bolesnici (u dobi ≥65 godina)
English: If any of these happen tell your doctor immediately.
Croatian: Ako se bilo što od ovoga dogodi, odmah obavijestite svog liječnika.
English: After the end of the infusion, velaglucerase alfa serum concentrations fell rapidly in a monophasic or biphasic fashion with a mean t1/2 ranging from 5 to 12 minutes at doses of 15, 30, 45, and 60 Units/kg.
Croatian: Nakon završetka infuzije, koncentracija velagluceraze alfa u serumu naglo je pala, monofazično ili bifazično, sa srednjom vrijednošću t1/2 u rasponu od 5 do 12 minuta pri dozama od 15, 30, 45 i 60 jedinica/kg.
English: Each 400 Units vial of this medicine contains 12.15 mg sodium.
Croatian: Svaka bočica ovog lijeka od 400 jedinica sadržava 12,15 mg natrija.
English: Velaglucerase alfa is manufactured to contain predominantly high-mannose-type glycans to facilitate internalisation of the enzyme by the phagocytic target cells via the mannose receptor.
Croatian: Velagluceraza alfa se proizvodi tako da sadržava prvenstveno glikane visoko manoznog tipa kako bi se olakšala internalizacija enzima od strane ciljanih fagocitnih stanica putem receptora za manozu.
English: - If the reaction is severe, your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.
Croatian: Ako je reakcija teška, liječnik će odmah prekinuti intravensku infuziju te započeti odgovarajuće liječenje.
English: There is no experience with overdose of velaglucerase alfa.
Croatian: Nema iskustva s predoziranjem velaglucerazom alfa.
English: Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Croatian: Bolesnice koje imaju Gaucherovu bolest i ostanu trudne mogu ući u razdoblje pojačane aktivnosti bolesti tijekom trudnoće i babinja.
English: - The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 “VPRIV contains sodium”).
Croatian: Drugi sastojci su saharoza, natrijev citrat dihidrat, citratna kiselina hidrat i polisorbat 20 (vidjeti dio 2 „VPRIV sadržava natrij“).
English: In Study 025EXT, 7 of 10 patients received home therapy at least once during 60 months of treatment.
Croatian: U ispitivanju 025EXT, 7 od 10 bolesnika primilo je terapiju kod kuće najmanje jednom tijekom 60 mjeseci liječenja.
English: • Guide for Healthcare Professionals Treating Patients with Gaucher Disease;
Croatian: • vodič za zdravstvene radnike koji liječe bolesnike s Gaucherovom bolešću;