FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you are given Vimizim
Croatian: Što morate znati prije nego počnete primati Vimizim
English: o all patients should receive antihistamines with or without antipyretics 30-60 minutes prior to the start of infusion o appropriate medical support should be readily available when VIMIZIM® is administered o the need to immediately stop the infusion and initiate appropriate medical treatment if these reactions occurred
Croatian: o svi bolesnici trebaju primati antihistaminike sa ili bez antipiretika 30-60 minuta prije početka infuzije o odgovarajuća medicinska pomoć treba biti lako dostupna prilikom primjene lijeka VIMIZIM o potreba da se odmah zaustavi infuzija i uvede odgovarajuće liječenje ukoliko se dogodi takva reakcija
English: However, patients with positive neutralizing antibodies responses had decreased total clearance (CL) values and prolonged t1/2.
Croatian: Međutim, ispitanici s pozitivnim neutralizirajućim odgovorom protutijela imali su smanjene vrijednosti ukupnog klirensa (CL) i produljeni t1/2.
English: Vimizim contains an enzyme called elosulfase alfa, which belongs to a group of medicines known as enzyme replacement therapies.
Croatian: Vimizim sadrži enzim koji se zove elosulfaza alfa koji pripada grupi lijekova pod nazivom enzimska nadomjesna terapija.
English: The majority of adverse reactions in clinical studies were IRs, which are defined as reactions occurring after initiation of infusion until the end of the day following the infusion.
Croatian: Većina nuspojava u kliničkim ispitivanjima bile su reakcije povezane s infuzijom koje se definiraju kao reakcije koje su se dogodile nakon početka infuzije pa do isteka sljedećeg dana.
English: This is equivalent to 0.4 % of the recommended daily dietary intake of sodium for an adult.
Croatian: To odgovara 0,4% preporučenog dnevnog unosa natrija za odraslu osobu.
English: You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Croatian: Morate reći svom liječniku prije nego primite ovaj lijek ako Vi (ili Vaše dijete) imate nasljedno nepodnošenje fruktoze ili ako Vaše dijete više ne može konzumirati slatku hranu ili piti slatka pića zbog pojave mučnine, povraćanja ili neugodnih nuspojava poput nadutosti, grčeva u trbuhu ili proljeva.
English: Because this is a protein solution, slight flocculation (thin translucent fibres) may occur.
Croatian: Budući da se radi o otopini proteina, moguća je blaga flokulacija (tanka poluprozirna vlakna).
English: A total of 235 patients with MPS IVA were enrolled and exposed to Vimizim in six clinical studies.
Croatian: Ukupno je 235 bolesnika s MPS IV A uključeno i izloženo Vimizimu u šest kliničkih ispitivanja.
English: Your doctor or nurse will give you some medicines before your treatment to reduce allergic reactions and you may also be given medicines to help control any fever.
Croatian: Vaš liječnik ili medicinska sestra će Vam prije liječenja dati određene lijekove kako bi smanjili alergijske reakcije i također će Vam dati lijekove za eventualnu vrućicu.
English: The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator in advance in order to allow them to reach 23C - 27C.
Croatian: Broj bočica koji je potrebno razrijediti ovisi o individualnoj težini bolesnika i mora se odrediti i unaprijed izvaditi iz hladnjaka kako bi postigao temperaturu od 23°C - 27°C.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology evaluating central nervous, respiratory and cardiovascular systems, single-dose and repeated-dose toxicity in rats and monkeys or fertility and embryo-foetal development in rats or rabbits.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih kliničkih ispitivanja sigurnosne farmakologije gdje su procjenjivani središnji živčani, dišni, srčani i krvožilni sustavi, toksičnosti pojedinačne doze i toksičnosti ponovljenih doza kod štakora i majmuna ili plodnosti i embriofetalnog razvoja štakora i kunića.
English: All patients were treated with antihistamines prior to each infusion.
Croatian: Svi su ispitanici bili na terapiji antihistaminicima prije svake infuzije.
English: For patients who have experienced allergic reactions during infusion, caution should be exercised upon re-administration.
Croatian: Za bolesnike koji su imali alergijsku reakciju za vrijeme infuzije, potreban je oprez prilikom ponovne primjene.
English: Dizziness was reported during Vimizim infusions; if dizziness occurs after the infusion, the ability to drive and use machines may be affected.
Croatian: Prijavljeni su slučajevi omaglice povezane s infuzijom Vimizima; ako se omaglica pojavi nakon infuzije može se smanjiti sposobnost upravljanja vozilima i strojevima.
English: Your doctor may also give you additional medicines to manage any allergic reactions (e.g. antihistamines and/or corticosteroids).
Croatian: Liječnik Vam može dati i dodatne lijekove za zbrinjavanje bilo koje alergijske reakcije (npr. antihistaminici i/ili kortikosteroidi).
English: Despite the alteration of the pharmacokinetics profile, presence of neutralizing antibodies did not affect pharmacodynamics, efficacy, or safety of the patients who were treated with elosulfase alfa.
Croatian: Usprkos promjenama farmakokinetičkog profila, prisutnost neutralizirajućih protutijela nije utjecala na farmakodinamiku, djelotvornost ili sigurnost ispitanika liječenih elosulfazom alfa.
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne smiju primiti ovaj lijek osim ako je to strogo nužno.
English: The safety and efficacy of Vimizim was assessed in a randomised, double-blind, placebo-controlled, Phase 3 clinical study of 176 patients with MPS IVA, ranging in age from 5 to 57 years.
Croatian: Sigurnost i djelotvornost Vimizima procijenjene su u randomiziranoj, dvostruko slijepoj, placebom kontroliranoj kliničkog ispitivanja faze 3 na 176 ispitanika s MPS IV A, u dobi od 5 do 57 godina.
English: At Week 22, the mean AUC0-t and Cmax increased by 181% and 192%, respectively, when compared to Week 0
Croatian: U 22. tjednu, srednja vrijednost AUC0-t bila je povećana za 181%, a Cmax za 192% u usporedbi s 0. tjednom.
English: The results from the every other week regimen in the distance walked in 6 minutes or in stairs climbed per minute were comparable to placebo.
Croatian: Rezultati za režim liječenja svaki drugi tjedan na udaljenost prehodanu u 6 minuta ili broj prijeđenih stepenica u minuti bili su usporedivi s placebom.
English: Patients should receive antihistamines with or without antipyretics prior to infusion (see section 4.2).
Croatian: Bolesnici trebaju primiti antihistaminike s ili bez antipiretika prije infuzije (vidjeti dio 4.2).
English: You must not receive Vimizim - if you have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Vimizim - Ako ste doživjeli po život opasnu alergijsku reakciju na elosulfazu alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: MedDRA Preferred term
Croatian: MedDRA Preporučeni izraz
English: Preparation of the Vimizim infusion (Use aseptic technique)
Croatian: Priprema infuzije Vimizima (primijenite aseptičku tehniku)
English: Sustained improvements in efficacy measures and reductions in urine keratan sulphate (KS) over time were observed across studies, despite the presence of anti elosulfase alfa antibodies.
Croatian: Održano poboljšanje u mjerama djelotvornosti i smanjenja keratan sulfata (KS) u mokraći s vremenom su primijećeni u ispitivanjima, usprkos prisutnosti protutijela na elosulfazu alfa.
English: Table 3: Results from placebo-controlled clinical study at 2 mg per kg per week
Croatian: Tablica 3: Rezultati u placebom kontroliranom kliničkom ispitivanju pri dozi od 2 mg/kg tjelesne težine tjedno
English: For management of adverse reactions, see sections 4.4 and 4.8.
Croatian: Za zbrinjavanje nuspojava vidjeti dio 4.4 i 4.8.
English: The accumulation leads to widespread cellular, tissue, and organ dysfunction.
Croatian: Nakupljanje dovodi do opsežnih poremećaja u stanicama, tkivu i disfunkciji organa.
English: An infusion reaction is any side effect, including an allergic reaction, occurring during the infusion or within a day following infusion (see section 4).
Croatian: Bilo koja reakcija na infuziju je nuspojava, uključujući alergijsku reakciju, koja se događa za vrijeme infuzije ili do kraja idućeg dana nakon nje (pogledajte dio 4).
English: Tmax, minute¶ * AUC0-t, area under the plasma concentration-time curve from time zero to the time of last measurable concentration; † Cmax, observed maximum plasma concentration; ‡ CL, total clearance of elosulfase alfa after intravenous administration; § t1/2, elimination half-life; ¶ Tmax, time from zero to maximum plasma concentration
Croatian: * AUC0-t, površina ispod krivulje koncentracija u plazmi-vrijeme od vremena nula do vremena posljednje mjerljive koncentracije; † Cmax, zabilježena maksimalna koncentracija u plazmi; ‡ CL, ukupni klirens elosulfaze alfa nakon intravenske primjene; § t1/2, poluvrijeme eliminacije; ¶ Tmax, vrijeme od nule do maksimalne koncentracije u plazmi
English: The total volume of the infusion is determined by the patient's body weight.
Croatian: Ukupni volumen infuzije određuje se na osnovu bolesnikove tjelesne težine.
English: CL, ml/minute/kg‡ t1/2, minute§
Croatian: AUC0-t, minuta • µg/ml* Cmax, µg/ml† CL, ml/minuta/kg‡ t1/2, minuta§
English: Re-administration after a severe reaction should be carried out with caution and close monitoring by the treating physician.
Croatian: Ponovna primjena nakon teške reakcije mora se provesti oprezno i potreban je poman liječnički nadzor tijekom primjene lijeka.
English: Symptoms of allergic reaction include rash, itching or hives on the skin (seen commonly - may affect up to 1 in 10 people).
Croatian: Simptomi alergijskih reakcija uključuju osip, svrbež ili koprivnjaču na koži (uočene često - mogu se pojaviti kod do 1 na 10 osoba).
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne mogu razgraditi fruktozu, što može uzrokovati ozbiljne nuspojave.
English: If these reactions occur, immediately stop the infusion and initiate appropriate medical treatment.
Croatian: Ako se te reakcije dogode, odmah prekinite infuziju i započnite odgovarajuće liječenje.
English: Because of the potential for hypersensitivity reactions with elosulfase alfa, patients should receive antihistamines with or without antipyretics 30 to 60 minutes prior to start of infusion (see section 4.4).
Croatian: Radi potencijalnih reakcija preosjetljivosti na elosulfazu alfa, bolesnici trebaju primiti antihistaminike sa ili bez antipiretika 30 do 60 minuta prije početka infuzije (vidjeti dio 4.4).
English: What Vimizim contains
Croatian: Što Vimizim sadrži
English: The most common symptoms of IRs (occurring in ≥ 10% of patients treated with Vimizim and ≥ 5% more when compared to placebo) were headache, nausea, vomiting, pyrexia, chills and abdominal pain.
Croatian: Najčešći simptomi reakcija povezanih s infuzijom (koji su se dogodili u ≥ 10% ispitanika liječenih Vimizimom i ≥ 5% više u usporedbi s placebom) bili su glavobolja, mučnina, povraćanje, pireksija, zimica i bolovi u trbuhu.
English: Available reproductive data in animals have shown excretion of elosulfase alfa in milk.
Croatian: Dostupni reproduktivni podaci kod životinja pokazali su da se elosulfaza alfa izlučuje u mlijeko.
English: - If you experience back pain, numbness in your arms or legs, or lack of control over passing urine or stools, you should immediately contact your doctor.
Croatian: Ako osjetite bol u leđima, utrnulost u rukama ili nogama ili nedostatak kontrole mokrenja ili stolice, odmah se trebate javiti svom liječniku.
English: Mucopolysaccharidoses comprises a group of lysosomal storage disorders caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAG).
Croatian: Mukopolisaharidoza je grupa poremećaja skladištenja u lizosomima uzrokovanih nedostatkom specifičnih lizosomskih enzima potrebnih za katabolizam glikozaminoglikana (GAG).
English: Approximately 80% of patients developed neutralizing antibodies capable of inhibiting the elosulfase alfa from binding to the cationindependent mannose-6-phosphate receptor.
Croatian: Otprilike 80% bolesnika razvilo je neutralizirajuća antitijela sposobna inhibirati vezanje elosulfaze alfa na kation neovisni manoza-6-fosfat receptor.
English: In clinical studies, doses of elosulfase alfa were explored up to 4 mg/kg per week and no specific signs or symptoms were identified following the higher doses.
Croatian: U kliničkim ispitivanjima elosulfaza alfa istražena je u dozama do 4 mg/kg/tjedno i nisu identificirani specifični znakovi ili simptomi s većim dozama.
English: Patients should be monitored for signs and symptoms of SCC (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.
Croatian: Bolesnike je potrebno nadzirati za znakove i simptome kompresije kralježničke/cervikalne moždine (uključujući bol u leđima, paralizu udova ispod razine kompresije, urinarnu inkontinenciju i inkontinenciju stolice) i dati im odgovarajuću medicinsku skrb.
English: In patients < 5 years of age, the overall safety profile of Vimizim at 2 mg/kg/week was consistent with the safety profile of Vimizim observed in older children.
Croatian: U bolesnika < 5 godina starosti, cjelokupni sigurnosni profil Vimizima pri 2 mg/kg/tjedno bio je u skladu sa sigurnosnim profilom Vimizima uočenim u starije djece.
English: Anaphylaxis and severe allergic reactions have been reported in clinical studies.
Croatian: Anafilaksija i teške alergijske reakcije prijavljene su u kliničkim ispitivanjima.
English: Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion reactions”).
Croatian: Nuspojave su najčešće uočene za vrijeme davanja lijeka ili neposredno nakon toga („reakcije na infuziju”).
English: In additional extension studies, patients receiving elosulfase alfa 2 mg/kg every week, showed maintenance of initial improvement in endurance and sustained reduction of urinary KS up to 156 weeks.
Croatian: U dodatnim produžetcima ispitivanja, bolesnici koji su primili elosulfazu alfa u dozi 2 mg/kg svaki tjedan, pokazali su održavanje početnog poboljšanja izdržljivosti i održanom smanjenju KS-a u mokraći u trajanju do 156 tjedana.
English: Other medicines and Vimizim Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: No effect on fertility was observed in animals.
Croatian: Nije uočen utjecaj na plodnost kod životinja.
English: The most serious side effects were severe allergic reactions (seen uncommonly - may affect up to 1 in 100 people) and mild to moderate vomiting (seen very commonly - may affect more than 1 in 10 people).
Croatian: Najozbiljnije nuspojave bile su teške alergijske reakcije (uočene manje često - mogu se pojaviti kod 1 od 100 osoba) i blago do umjereno povraćanje (uočene vrlo često - mogu se pojaviti kod do 1 na 10 osoba).
English: After the first 52 weeks of treatment the normalised standing height z-score was -1.9 (±1.62).
Croatian: Nakon prva 52 tjedna liječenja, normalizirana z-vrijednost visine u stojećem položaju iznosila je -1,9 (±1,62).
English: They accumulate in the tissues interfering with their normal function and causing the symptoms of MPS IVA, such as difficulty walking, trouble breathing, short height, and hearing loss.
Croatian: One se akumuliraju u tkivima, što utječe na njihove normalne funkcije i uzrokuje simptome bolesti MPS IV A, kao što su otežano hodanje, otežano disanje, nizak rast i gubitak sluha.
English: Each 5 ml vial contains 8 mg sodium and 100 mg sorbitol (E420).
Croatian: Jedna bočica od 5 ml sadrži 8 mg natrija i 100 mg sorbitola (E420).
English: It is used to treat adults and children with mucopolysaccharidosis type IVA (MPS IVA disease, also known as Morquio A Syndrome).
Croatian: Upotrebljava se za liječenje odraslih i djece koji boluju od mukopolisaharidoze tip IV A (MPS IV A bolest, također poznata i kao Morquiov A sindrom).
English: This medicine contains 8 mg sodium (main component of cooking/table salt) in each 5 ml vial.
Croatian: Ovaj lijek sadrži 8 mg natrija (glavni sastojak kuhinjske/stolne soli) u jednoj bočici od 5 ml.
English: The number of vials to be diluted based on the individual patient's weight and the recommended dose of 2 mg/kg is determined, using the following calculation:
Croatian: Broj bočica koji je potrebno razrijediti ovisi o individualnoj težini bolesnika, a preporučena doza je 2 mg/kg koja se određuje pomoću sljedeće formule:
English: Clinical studies performed with Vimizim assessed the impact of treatment on the systemic manifestations of MPS IVA in various domains including endurance, respiratory function, growth velocity, and mobility, as well as urine KS.
Croatian: Klinička ispitivanja provedene s Vimizimom procijenile su učinak liječenja na sistemske manifestacije MPS IV A u raznim područjima uključujući izdržljivost, respiratornu funkciju, brzinu rasta i mobilnost, kao i učinak na KS u mokraći.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of elosulfase alfa.
Croatian: Posljedično, ne očekuje se da će oštećenje funkcije jetre utjecati na farmakokinetiku elosulfaze alfa.
English: The appropriate number of vials is removed from the refrigerator.
Croatian: Iz hladnjaka se vadi odgovarajući broj bočica.
English: Administration of Vimizim should be carried out by an appropriately trained healthcare professional with the ability to manage medical emergencies.
Croatian: Vimizim mora davati zdravstveni radnik odgovarajuće educiran za zbrinjavanje hitnih stanja.
English: Male and female patients had comparable elosulfase alfa clearance, and clearance did not trend with age or weight at week 22.
Croatian: Muški i ženski ispitanici imali su usporedivi klirens elosulfaze alfa, a klirens nije pokazao trend povezan s dobi ili težinom u 22. tjednu.
English: People with MPS IVA disease either lack completely or do not have enough N-acetylgalactosamine-6sulfatase, an enzyme which breaks down specific substances in the body such as keratan sulphate, which are found in many tissues of the body, including cartilage and bone.
Croatian: Osobe koje boluju od MPS IV A ili uopće nemaju ili nemaju dovoljno enzima koji se zove Nacetilgalaktozamin-6-sulfataza, koji razlaže specifične tvari u tijelu kao npr. keratan sulfat koji se nalazi u mnogim tkivima u tijelu, uključujući hrskavicu i kosti.
English: • Patient weight (kg) multiplied by 2 (mg/kg) = Patient dose (mg)
Croatian: • Tjelesna težina bolesnika (kg) pomnožena s 2 (mg/kg) = bolesnikova doza (mg)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mg/5 ml
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 5 mg/5 ml
English: The difference was greatest between the placebo group and the weekly treatment group for all endpoints.
Croatian: Razlika je u svim mjerama ishoda bila najveća između placebo grupe i grupe tjednog liječenja.
English: The data in Table 2 below describes adverse reactions from clinical studies in patients treated with Vimizim.
Croatian: Podaci u Tablici 2 u nastavku opisuju nuspojave iz kliničkih ispitivanja kod bolesnika liječenih Vimizimom.
English: The infusion bag is gently rotated to ensure proper distribution of Vimizim.
Croatian: Infuzijsku vrećicu potrebno je lagano okretati kako bi se osigurala pravilna raspodjela Vimizima.
English: The pharmacokinetic parameters of elosulfase alfa were evaluated in 23 patients with MPS IVA who received weekly intravenous infusions of 2 mg/kg of elosulfase alfa over approximately 4 hours for 22 weeks and the parameters at Week 0 and Week 22 were compared.
Croatian: Farmakokinetički parametri elosulfaze alfa procijenjeni su kod 23 ispitanika s MPS IV A koji su primali tjednu intravensku infuziju od 2 mg/kg elosulfaze alfa u trajanju od otprilike 4 sata tijekom 22 tjedna, a usporedili su se parametri u 0. tjednu i 22. tjednu.
English: Dizziness was reported in some patients during the Vimizim infusion.
Croatian: Prijavljeni su slučajevi omaglice kod nekih bolesnika za vrijeme infuzije Vimizima.
English: Each infusion will be given over approximately 4 hours.
Croatian: Svaka infuzija daje se s trajanjem oko 4 sata.
English: IgE antibodies against elosulfase alfa were detected in ≤ 10% of treated patients and have not consistently been related to anaphylaxis or other hypersensitivity reactions and/or treatment withdrawal.
Croatian: IgE protutijela protiv elosulfaze alfa otkrivena su u ≤ 10% liječenih ispitanika i nisu bila dosljedno povezana s anafilaksijom ili drugim reakcijama preosjetljivosti i/ili povlačenjem liječenja.
English: *Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
Croatian: *Elosulfaza alfa je rekombinantni oblik humane N-acetilgalaktozamin-6-sulfataze (rhGALNS), a proizvodi se tehnologijom rekombinantne DNK na staničnoj kulturi jajnika kineskog hrčka.
English: Based on the severity of the side effect, your doctor may slow or temporarily interrupt the infusion and/ or give you additional medicines to reduce the effects of a severe allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics).
Croatian: Na temelju težine nuspojava, liječnik može usporiti ili privremeno prekinuti infuziju i/ili Vam dati dodatne lijekove za smanjenje teške alergijske reakcije (npr. antihistaminici i/ili kortikosteroidi) ili za snižavanje vrućice (antipiretici).
English: MPS IVA is characterised by the absence or marked reduction in N-acetylgalactosamine-6-sulfatase activity.
Croatian: MPS IV A je karakterizirana odsustvom ili značajnim smanjenjem aktivnosti N-acetilgalaktozamin-6-sulfataze.
English: IRs were generally mild or moderate, and the frequency was higher during the first 12 weeks of treatment and tended to occur less frequently with time.
Croatian: Reakcije povezane s infuzijom su općenito bile blage do umjerene, a učestalost je bila veća prvih 12 tjedana liječenja i s vremenom su postajale sve rjeđe.
English: The diluted solution should be used immediately.
Croatian: Razrijeđena otopina mora se odmah upotrijebiti.
English: Table 4: Pharmacokinetic properties
Croatian: Tablica 4: Farmakokinetička svojstva
English: Vimizim has minor influence on the ability to drive and use machines.
Croatian: Vimizim malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Step 1 Initial infusion rate 0-15 minutes (ml/hr)
Croatian: Korak 1 Početna brzina infuzije 0-15 minuta (ml/sat)
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave se prikazuju od najozbiljnije do najmanje ozbiljne.
English: Common side effects observed was muscle pain.
Croatian: Česte nuspojave bile su bol u mišićima.
English: Reproduction studies have been performed in rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or reproductive performance.
Croatian: Ispitivanja reprodukcije provedena na štakorima u dozama do 10 puta većim od humane doze nisu dala dokaze o smanjenoj plodnosti ili smanjenim rezultatima kod razmnožavanja.