FrancophonIA/ELRC3.0 huggingface dataset:
English: As expected for a protein of this size, the steady-state volume of distribution was low (0.27 L/kg), indicating distribution confined to plasma.
Croatian: Kao što se i očekuje za protein ove veličine, volumen distribucije u stanju dinamičke ravnoteže bio je nizak (0,27 l/kg), pokazujući da je distribucija ograničena na plazmu.
English: Due to the nature of the medicinal product, the reconstituted solution may occasionally contain some proteinaceous particles in form of thin white strands or translucent fibers which will be removed by the in-line filter during infusion (see point e).
Croatian: Zbog prirode ovog lijeka, rekonstituirana otopina može ponekad sadržavati nešto proteinskih čestica u obliku tankih bijelih niti ili prozirnih vlakana koje će ukloniti ugrađeni filtar tijekom infuzije (vidjeti točku e).
English: The development of antibodies has not been shown to affect clinical efficacy or safety.
Croatian: Nije dokazano da razvoj protutijela utječe na kliničku djelotvornost ili sigurnost.
English: - if you are allergic to velmanase alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na velmanazu alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The infusion duration should be a minimum of 50 minutes.
Croatian: Infuzija mora trajati najmanje 50 minuta.
English: Most side effects occur during the infusion or shortly after (“infusion-related reaction”, see section 2 Warnings and precautions).
Croatian: Većina nuspojava nastane tijekom ili neposredno nakon infuzije („reakcija povezana s infuzijom“, pogledajte dio 2 „Upozorenja i mjere opreza“).
English: In total 15 patients (7 paediatrics and 8 adults) received active treatment and 10 patients received placebo (5 paediatrics and 5 adults).
Croatian: Ukupno je 15 bolesnika (7 pedijatrijskih i 8 odraslih) primalo aktivno liječenje, dok je 10 bolesnika primalo placebo (5 pedijatrijskih i 5 odraslih).
English: The effects of velmanase alfa were more evident in patients younger than 18 years.
Croatian: Učinci velmanaze alfa bili su očitiji u bolesnika mlađih od 18 godina.
English: The maximum infusion rate is 25 mL/hour (see section 4.2).
Croatian: Najveća brzina infuzije je 25 ml/sat (vidjeti dio 4.2).
English: White to off-white powder.
Croatian: Bijeli do gotovo bijeli prašak.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake ‘EXP'.
English: Minimum infusion time (min)
Croatian: Najkraće trajanje infuzije (min)
English: f) When the last syringe is empty, the dosage syringe is replaced with a 20 mL syringe filled with sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: f) Kad se isprazni i zadnja štrcaljka, štrcaljka za doziranje zamijeni se štrcaljkom od 20 ml napunjenom otopinom natrijevog klorida od 9 mg/ml (0,9%) za injekcije.
English: What Lamzede looks like and contents of the pack
Croatian: Kako Lamzede izgleda i sadržaj pakiranja
English: As the accumulation of end organ damage progresses over time, it is more difficult for the treatment to reverse the damage or to show improvements.
Croatian: Budući da s vremenom dolazi do progresije oštećenja ciljnih organa, liječenjem je sve teže poništiti to oštećenje ili dovesti do poboljšanja.
English: - If you have an infusion-related reaction you may be given additional medicines to treat or help prevent future reactions.
Croatian: Ako imate reakciju povezanu s infuzijom, mogu Vam dati dodatne lijekove za liječenje ili sprječavanje budućih reakcija.
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Croatian: Teška alergijska reakcija na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The safety profile of velmanase alfa in clinical studies involving children and adolescents was similar to that observed in adult patients.
Croatian: Sigurnosni profil velmanaze alfa u kliničkim ispitivanjima koja su uključivala djecu i adolescente bio je sličan onome opaženom u odraslih bolesnika.
English: The numerical improvement of most clinical endpoints over placebo (2 to 8 %) observed in the year of observation could be suggestive of the ability of velmanase alfa to slow down the existing disease progression.
Croatian: Brojčano poboljšanje većine kliničkih mjera ishoda u odnosu na placebo (od 2% do 8%) opaženo u godinu dana promatranja moglo bi ukazivati na sposobnost velmanaze alfa da uspori napredovanje postojeće bolesti.
English: A slower infusion rate may be prescribed when clinically appropriate according to the physician's judgment, for example at the beginning of the treatment or in case of previous infusion-related reactions (IRRs).
Croatian: Manja brzina infuzije može se propisati kad je to, prema procjeni liječnika, klinički primjereno, na primjer, na početku liječenja ili u slučaju prethodnih reakcija povezanih s infuzijom.
English: Animal studies do not show evidence of impaired fertility.
Croatian: Ispitivanja na životinjama ne pokazuju dokaze narušene plodnosti.
English: The effects of treatment with velmanase alfa should be periodically evaluated and discontinuation of treatment considered in cases where no clear benefits could be observed.
Croatian: Učinke liječenja velmanazom alfa treba periodički procijeniti te razmotriti prekid liječenja u slučajevima u kojima korist nije jasno vidljiva.
English: If the number of calculated vials includes a fraction, it should be rounded up to the next whole number.
Croatian: Ako se izračunom ne dobije cijeli broj bočica, potrebno ga je zaokružiti na sljedeći cijeli broj.
English: Nevertheless, the absorption of any ingested milk-containing velmanase alfa in the breastfed child is considered to be minimal and no untoward effects are therefore anticipated.
Croatian: Ipak, smatra se da je apsorpcija velmanaze alfa u dojenog djeteta iz progutanog majčinog mlijeka minimalna te se stoga ne očekuju nikakvi nepovoljni učinci.
English: rhLAMAN-10 study n=33
Croatian: Ispitivanje rhLAMAN-10 n=33
English: It should be considered by the treating physician that the administration of velmanase alfa does not affect the irreversible complications (i.e. skeletal deformities, disostosis multiplex, neurological manifestations and impaired cognitive function).
Croatian: Nadležni liječnik treba uzeti u obzir da primjena velmanaze alfa ne utječe na ireverzibilne komplikacije (tj. deformitete skeleta, multiple disostoze, neurološke manifestacije i oštećenja kognitivnih funkcija).
English: Metabolism and nutrition disorders Increased appetite
Croatian: Poremećaji metabolizma i prehrane pojačan apetit
English: FVC (% of predicted) Overall
Croatian: FVC (% predviđenog)
English: In one patient, loss of consciousness considered related to the study treatment with recovery after a few seconds was reported.
Croatian: U jednog se bolesnika gubitak svijesti smatrao povezanim s ispitivanim liječenjem, s time da je zabilježen oporavak nakon nekoliko sekundi.
English: Treatment with velmanase alfa for 12 months (n=15)
Croatian: Liječenje velmanazom alfa tijekom 12 mjeseci (n=15)
English: In such a case, treatment with an antihistamine and corticosteroids should be considered as being appropriate.
Croatian: U takvom se slučaju treba smatrati primjerenim liječenje antihistaminikom i kortikosteroidima.
English: Each carton contains 1, 5 or 10 vials.
Croatian: Jedna kutija sadrži 1, 5 ili 10 bočica.
English: What Lamzede is and what it is used for What you need to know before Lamzede is used How Lamzede is used
Croatian: Što je Lamzede i za što se koristi Što morate znati prije nego počnete primjenjivati Lamzede Kako primjenjivati Lamzede
English: It is given for the treatment of non-neurological symptoms of the disease.
Croatian: Daje se za liječenje simptoma bolesti koji nisu neurološke naravi.
English: Pack sizes of 1, 5 or 10 vials per carton.
Croatian: Veličine pakiranja od 1, 5 ili 10 bočica u kutiji.
English: The total volume of infusion is determined by the patient's weight and should be administrated over a minimum of 50 minutes.
Croatian: Ukupni volumen infuzije određuje se prema tjelesnoj težini bolesnika i treba ga primijeniti tijekom najmanje 50 minuta.
English: Treatment with placebo for 12 months (n=10)
Croatian: Liječenje placebom tijekom 12 mjeseci (n=10)
English: Data suggest that the beneficial effects of the treatment with velmanase alfa diminish with the increase of disease burden and disease-related respiratory infections.
Croatian: Podaci ukazuju na slabljenje povoljnih učinaka liječenja velmanazom alfa s povećanjem opterećenja bolešću i respiratornih infekcija povezanih s bolešću.
English: For the calculation of the infusion rate and the infusion time based on body weight see the table in section 6.6.
Croatian: Za izračunavanje brzine i trajanja infuzije na temelju tjelesne težine, vidjeti tablicu u dijelu 6.6.
English: For further instructions, see section 4.4.
Croatian: Za dodatne upute vidjeti dio 4.4.
English: Criterion
Croatian: Kriterij
English: Proteins larger than 50,000 Da, such as velmanase alfa, are not eliminated renally.
Croatian: Proteini veći od 50 000 Da, kao što je velmanaza alfa, ne eliminiraju se putem bubrega.
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stanovišta, lijek se mora primijeniti odmah.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Croatian: Dokazano je da je lijek u primjeni kemijski i fizikalno stabilan 24 sata na temperaturi od 2°C - 8°C.
English: If you are treated with Lamzede, you may experience a side effect during or immediately following the drip (infusion) used to give the medicine (see section 4).
Croatian: Ako se liječite lijekom Lamzede, možete osjetiti nuspojave tijekom ili neposredno nakon infuzije (dripa) kojom se daje lijek (pogledajte dio 4).
English: There is a potential for immunogenicity.
Croatian: Imunogeničnost je moguća.
English: As velmanase alfa aims at normalizing alpha-mannosidase in alpha-mannosidosis patients, Lamzede should be used during pregnancy only when strictly needed.
Croatian: Budući da je cilj primjene velmanaze alfa normalizacija alfa-manozidaze u bolesnika s alfa-manozidozom, Lamzede se treba primjenjivati tijekom trudnoće samo kad je to prijeko potrebno.
English: If not used immediately, the reconstituted solution should be stored in a refrigerator for no longer than 24 hours.
Croatian: Ako se ne primijeni odmah, rekonstituiranu otopinu potrebno je čuvati u hladnjaku ne dulje od 24 sata.
English: The infusion duration should be calculated individually considering a maximum infusion rate of 25 mL/hour to control the protein load.
Croatian: Trajanje infuzije treba izračunati posebno za svakog pojedinog bolesnika, uzimajući u obzir maksimalnu brzinu infuzije od 25 ml/sat kako bi se kontroliralo opterećenje proteinima.
English: A total of 25 patients were enrolled, including 12 paediatric subjects (age range: 6 to 17 years; mean: 10.9 years) and 13 adult subjects (age range: 18 to 35 years; mean: 24.6).
Croatian: Ukupno je bilo uključeno 25 bolesnika, uključujući 12 pedijatrijskih ispitanika (raspon dobi: od 6 do 17 godina; srednja vrijednost: 10,9 godina) i 13 odraslih ispitanika (raspon dobi: od 18 do 35 godina; srednja vrijednost: 24,6).
English: The patient later experienced epileptic seizures that were considered not related.
Croatian: Kasnije je taj bolesnik razvio epileptičke napadaje koji se nisu smatrali povezanima s ispitivanim liječenjem.
English: No clear correlation was found between antibody titres (velmanase alfa IgG antibody level) and reduction in efficacy or occurrence of anaphylaxis or other hypersensitivity reactions.
Croatian: Nije pronađena jasna korelacija između titra protutijela (razine IgG protutijela na velmanazu alfa) i smanjenja djelotvornosti ili nastanka anafilaksije ili drugih reakcija preosjetljivosti.
English: The management of IRRs should be based on the severity of the reaction and includes 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: Zbrinjavanje reakcija povezanih s infuzijom treba se temeljiti na težini reakcije, a uključuje smanjenje brzine infuzije, liječenje lijekovima kao što su antihistaminici, antipiretici i/ili kortikosteroidi i/ili prestanak i ponovni nastavak liječenja uz dulje trajanje infuzije.
English: <18 years(2) ≥18 years(2)
Croatian: < 18 godina(2) ≥ 18 godina(2)
English: After the end of the infusion, velmanase alfa plasma concentrations fell in a biphasic fashion with a mean terminal elimination half-life of about 30 hours.
Croatian: Nakon završetka infuzije, koncentracije velmanaze alfa u plazmi opadale su na bifazičan način uz srednju vrijednost terminalnog poluvijeka eliminacije od oko 30 sati.
English: There is no experience with patients younger than 6 years of age.
Croatian: Nema iskustva s primjenom u bolesnika mlađih od 6 godina.
English: These medicines may include medicines used to treat allergies (antihistamines), medicines used to treat fever (antipyretics) and medicines to control inflammation (corticosteroids).
Croatian: Ti lijekovi mogu uključivati lijekove za liječenje alergija (antihistaminike), lijekove za liječenje vrućice (antipiretike) i lijekove za kontrolu upale
English: - Infusion-related reactions include dizziness, headache, nausea, low blood pressure, tiredness and fever.
Croatian: - Reakcije povezane s infuzijom uključuju omaglicu, glavobolju, mučninu, nizak krvni tlak, umor i vrućicu.
English: During the infusion with this higher dose, fever of mild intensity and short duration (5 hours) was observed in one patient.
Croatian: Tijekom infuzije ove više doze u jednog je bolesnika opažena vrućica blagog intenziteta i kratkog trajanja (5 sati).
English: Velmanase alfa exhibited a linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased proportionally to the dose with doses ranging from 0.8 to 3.2 mg/kg (corresponding to 25 and 100 units/kg).
Croatian: Velmanaza alfa pokazala je linearan farmakokinetički profil (tj. prvog reda), a Cmax i AUC povećavali su se proporcionalno dozi u rasponu doza od 0,8 do 3,2 mg/kg (što odgovara 25, odnosno 100 jedinica/kg).
English: In both cases the patients recovered without sequelae.
Croatian: U oba slučaja bolesnici su se oporavili bez posljedica.
English: If the volume of the solution exceeds one syringe capacity, the required number of syringes should be prepared in order to replace the syringe quickly during the infusion.
Croatian: Ako je volumen otopine veći od kapaciteta štrcaljke, potrebno je pripremiti potreban broj štrcaljki kako bi se štrcaljka mogla brzo zamijeniti tijekom infuzije.
English: If you experience an infusion-related reaction, you must tell your doctor immediately.
Croatian: Ako osjetite reakciju povezanu s infuzijom, odmah morate obavijestiti svog liječnika.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lamzede in one or more subsets of the paediatric population in the treatment of alpha-mannosidosis disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Lamzede u jednoj ili više podskupina pedijatrijske populacije u liječenju bolesti alfa-manozidoze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This medicine is only to be used under the supervision of a doctor experienced in the treatment of alpha-mannosidosis or other similar diseases and should only be given by a healthcare professional.
Croatian: Ovaj se lijek smije primjenjivati samo pod nadzorom liječnika s iskustvom u liječenju alfa-manozidoze ili drugih sličnih bolesti i smije ga davati samo zdravstveni radnik.
English: Acute renal failure was of moderate severity leading to temporary discontinuation of the study treatment and fully resolved within 3 months.
Croatian: Akutno zatajenje bubrega bilo je umjerene težine i dovelo je do privremenog prekida ispitivanog liječenja te se potpuno povuklo unutar 3 mjeseca.
English: What you need to know before Lamzede is used Lamzede must not be used:
Croatian: Što morate znati prije nego počnete primjenjivati Lamzede Nemojte primjenjivati Lamzede:
English: - If the infusion-related reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies that might affect the outcome of your treatment.
Croatian: - Ako su reakcije povezane s infuzijom teške i/ili se izgubio učinak lijeka, liječnik će provesti krvnu pretragu kako bi provjerio jesu li prisutna protutijela koja bi mogla utjecati na ishod liječenja.
English: A total of 2 serious adverse reactions (loss of consciousness in 1 patient and acute renal failure in 1 patient) were observed.
Croatian: Ukupno su opažene 2 ozbiljne nuspojave (gubitak svijesti u 1 bolesnika i akutno zatajenje bubrega u 1 bolesnika).
English: Serum oligosaccharide concentration (μmol/l) Overall(1)
Croatian: Koncentracija oligosaharida u serumu (μmol/l) Ukupno(1)
English: p-value [95% CI]
Croatian: p-vrijednost [95% CI]
English: Hypersensitivity reactions have been reported in patients in clinical studies.
Croatian: Reakcije preosjetljivosti zabilježene su u bolesnika u kliničkim ispitivanjima.
English: Velmanase alfa vs. placebo
Croatian: Velmanaza alfa naspram placeba
English: In the most severe cases, the current medical standards for emergency treatment are to be observed.
Croatian: U najtežim slučajevima, potrebno je provesti liječenje hitnog stanja prema standardima suvremene medicinske prakse.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Croatian: Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Croatian: Farmakoterapijska skupina: drugi lijekovi za probavni sustav i metabolizam, enzimi.
English: - If the infusion-related reaction is severe, your doctor will stop the infusion immediately and start giving you appropriate medical treatment.
Croatian: Ako je reakcija povezana s infuzijom teška, liječnik će odmah zaustaviti infuziju i početi Vam davati odgovarajuću terapiju lijekovima.
English: Lamzede is supplied in a vial as a powder for infusion which will be made up with water for injections before being given.
Croatian: Lamzede se isporučuje u bočici kao prašak za infuziju koji će se prije davanja pripremiti s vodom za injekcije.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C.
Croatian: Ako se ne primijeni odmah, vrijeme proteklo do primjene i uvjeti čuvanja rekonstituiranog lijeka za to vrijeme odgovornost su korisnika i to obično ne bi smjelo biti dulje od 24 sata na temperaturi od 2°C do 8°C.
English: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko
English: Infusion-related reaction
Croatian: Reakcije povezane s infuzijom
English: For patients weighing less than 18 kg, and receiving less than 9 mL reconstituted solution, the infusion rate should be calculated so that the infusion time is ≥50 minutes.
Croatian: Za bolesnike tjelesne težine manje od 18 kg koji primaju manje od 9 ml rekonstituirane otopine, potrebno je izračunati brzinu infuzije tako da infuzija traje ≥ 50 minuta.
English: The recommended dose of Lamzede is 1 mg/kg of body weight given once every week.
Croatian: Preporučena doza lijeka Lamzede je 1 mg/kg tjelesne težine, primijenjena jedanput svakog tjedna.
English: Instructions for reconstitution and administration
Croatian: Upute za rekonstituciju i primjenu
English: If severe allergic or anaphylactic-type reactions occur, immediate discontinuation of velmanase alfa is recommended and current medical standards for emergency treatment are to be followed.
Croatian: Ako se jave teške alergijske ili anafilaktičke reakcije, preporučuje se odmah prekinuti primjenu velmanaze alfa i provesti liječenje hitnog stanja prema standardima suvremene medicinske prakse.
English: There were no apparent pharmacokinetic gender differences in patients with alpha-mannosidosis disease.
Croatian: Nije bilo vidljivih razlika u farmakokinetici između muških i ženskih bolesnika s bolešću alfa-manozidozom.
English: The recommended dose regimen is 1 mg/kg of body weight administered once every week by intravenous infusion at a controlled speed.
Croatian: Preporučeni režim doziranja je 1 mg/kg tjelesne težine primijenjen jedanput tjedno intravenskom infuzijom kontrolirane brzine.
English: After reconstitution, the medicine should be used immediately.
Croatian: Nakon rekonstitucije, lijek se mora primijeniti odmah.
English: The adverse reactions reflecting exposure of 33 patients treated with velmanase alfa in clinical studies are listed in the table 1 below.
Croatian: Nuspojave koje odražavaju izloženost 33 bolesnika liječena velmanazom alfa u kliničkim ispitivanjima navedene su niže u tablici 1.
English: The patient received saline infusion in a hospital setting and was then discharged after 6-hour observation.
Croatian: Bolesnik je primio infuziju fiziološke otopine u bolničkom okruženju te je bio otpušten nakon 6 sati promatranja.
English: Serum oligosaccharide concentration (µmol/L)
Croatian: Koncentracija oligosaharida u serumu (µmol/l)
English: Last observation % change from baseline (SD)
Croatian: % promjene od početne vrijednosti kod zadnjeg opažanja (SD)
English: IRRs (including hypersensitivity, nausea, vomiting, pyrexia, chills, feeling hot, malaise, urticaria, anaphylactoid reaction and hyperhidrosis) were reported in 9% of the patients (3 out of 33 patients) in clinical studies.
Croatian: Reakcije povezane s infuzijom (uključujući preosjetljivost, mučninu, povraćanje, pireksiju, zimicu, osjećaj vrućine, malaksalost, urtikariju, anafilaktoidnu reakciju i hiperhidrozu) bile su zabilježene u 9% bolesnika (3 od 33 bolesnika) u kliničkim ispitivanjima.
English: The maximum infusion rate is 25 mL/hour.
Croatian: Najveća brzina infuzije je 25 ml/sat.
English: Baseline actual value Mean (SD)
Croatian: Srednja vrijednost stvarne početne vrijednosti (SD)
English: In order to obtain long-term data on effectiveness and safety of treatment with Lamzede and to characterize the entire alpha-mannosidosis population, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a registry of patients with alpha-mannosidosis.
Croatian: Kako bi se prikupili dugoročni podaci o učinkovitosti i sigurnosti liječenja lijekom Lamzede te opisala cijela populacija s alfa-manozidozom, uključujući raznolikost kliničkih manifestacija, progresije i prirodnog tijeka bolesti, od nositelja odobrenja za stavljanje lijeka u promet traži se da podnese rezultate ispitivanja temeljene na odgovarajućem izvoru podataka uzetih iz registra bolesnika s alfa-manozidozom.
English: Linearity/(Non)linearity
Croatian: Linearnost/nelinearnost
English: Concomitant long-term treatment with high doses of ibuprofen was noted as a potentially causative contributor to the occurrence of the event.
Croatian: Zabilježeno je da je istodobno dugotrajno liječenje visokim dozama ibuprofena moguće doprinijelo nastanku tog događaja.
English: For infusion rate see section “Method of administration”.
Croatian: Za brzinu infuzije vidjeti dio „Način primjene“.