FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Intrarosa, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Intrarosa bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: The active substance of Intrarosa, prasterone, is converted into the sex hormones oestrogens and androgens when inserted into the vagina.
Croatian: Djelatna tvar lijeka Intrarosa, prasteron, pretvara se nakon umetanja lijeka u vaginu u spolne hormone estrogene i androgene.
English: How does Intrarosa work?
Croatian: Kako djeluje Intrarosa?
English: In women who have been through the menopause, the thinning of the tissues in and around the vagina is caused by a fall in levels of the sex hormone oestrogen.
Croatian: Stanjivanje tkiva u vagini i vaginalnom području u žena u postmenopauzi uzrokovano je sniženjem razine spolnog hormona estrogena.
English: For the full list of side effects reported with Intrarosa, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Intrarosa potražite u uputi o lijeku.
English: Strength Pharmaceutical Form Route of Administration
Croatian: 8 bočica + 8 napunjenih štrcaljki + 8 igala + 8 nastavaka za bočicu + 16 vatica
English: Pack size
Croatian: 12 napunjenih brizgalica + 12 vatica
English: Contaminated clothing should be removed immediately.
Croatian: Zagađenu odjeću treba odmah skinuti.
English: This summary was last updated in September 2017.
Croatian: Sažetak je posljednji put ažuriran u 09. 2017.
English: In case of eye contact, the affected eye should be rinsed thoroughly with water (contact lenses should be removed first).
Croatian: U slučaju kontakta s očima, zahvaćeno oko potrebno je temeljito isprati vodom (prvo treba ukloniti kontaktne leće).
English: The dispersion should be warmed to 30-35˚C before application.
Croatian: Disperziju je prije primjene potrebno zagrijati na 30 do 35 ˚C.
English: People must not eat, drink or smoke while using the medicine.
Croatian: Prilikom korištenja proizvoda ne smije se jesti, piti ni pušiti.
English: Used measuring devices and empty containers should be disposed of immediately in a safe way.
Croatian: Upotrijebljeni uređaji za mjerenje i prazni spremnici trebaju se odmah odložiti na siguran način.
English: The full EPAR for Oxybee can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Oxybee nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Hands and exposed skin should be washed with soap and plenty of water immediately.
Croatian: Ruke i izložena područja kože treba odmah oprati sapunom i oblinom količinom vode.
English: If the product is accidentally swallowed by a person, their mouth should be cleaned with water and water or milk should be drunk, but vomiting should not be induced.
Croatian: U slučaju da osoba nehotično proguta ovaj proizvod potrebno je očistiti usta vodom i piti vodu ili mlijeko, ali ne smije se izazivati povraćanje.
English: Dead mites were counted daily in the first study and three times per week in the second study for three weeks post treatment.
Croatian: U prvom ispitivanju mrtve grinje brojane su svakog dana, a u drugom ispitivanju tri puta tjedno tijekom tri tjedna nakon tretiranja.
English: The effectiveness of Oxybee to kill mites was 97% and 95% in these studies.
Croatian: Učinkovitost VMP-a Oxybee u ubijanju grinja u tim ispitivanjima bila je 97 % odnosno 95 %.
English: Protective clothing, acid resistant gloves and safety glasses should be worn during treatment.
Croatian: Tijekom tretiranja treba nositi zaštitnu odjeću, rukavice otporne na kiseline i zaštitne naočale.
English: In the first study treatment with Oxybee was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Oxybee was compared to a group with no treatment.
Croatian: U prvom ispitivanju liječenje VMP-om Oxybee uspoređeno je s drugim VMP-om koji sadržava oksalnu kiselinu i sa skupinom koja nije tretirana, dok je u drugom ispitivanju liječenje VMP-om Oxybee uspoređeno sa skupinom koja nije tretirana.
English: The most common side effect with Oxybee (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths.
Croatian: Najčešće nuspojave VMP-a Oxybee (mogu se javiti u više od 1 na 10 kolonija pčela) je povećana smrtnost pčela.
English: It is not intended to provide practical advice on how to use Oxybee.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Oxybee.
English: Oxybee is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose).
Croatian: VMP Oxybee visoke je kiselosti i može biti nadražujuć ili nagrizajuć za kožu, oči i sluznicu (sluznica tjelesnih šupljina kao što su usta ili nos).
English: Varroosis is a disease of honey bees caused by infestation with a parasite called varroa mite (Varroa destructor).
Croatian: Varooza je bolest medonosnih pčela uzrokovana infestacijom parazitom pod nazivom grinja varoe (Varroa destructor).
English: This is a summary of the European public assessment report (EPAR) for Oxybee.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) o veterinarsko-medicinskom proizvodu Oxybee.
English: Why is Oxybee approved?
Croatian: Zašto je Oxybee odobren?
English: The effectiveness of Oxybee against varroa mites was investigated in two field studies in European countries with different climates.
Croatian: Djelotvornost VMP-a Oxybee u suzbijanju grinja varoa istraživana je u dvama terenskim ispitivanjima u europskim zemljama različitih klima.
English: Medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: Potrebno je odmah potražiti liječnički savjet te pokazati uputu o proizvodu ili etiketu.
English: The withdrawal period for honey from honey bees treated with Oxybee is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za med medonosnih pčela liječenih VMP-om Oxybee iznosi „nula” dana, drugim riječima, nema obveznog razdoblja čekanja.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Oxybee's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Oxybee nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: A significant mite infestation can lead to the collapse of a honey bee colony.
Croatian: Veća infestacija grinjama može dovesti do kolapsa kolonije medonosnih pčela.
English: What is Oxybee and what is it used for?
Croatian: Što je Oxybee i za što se koristi?
English: Oxybee is trickled onto bees in the hive and should only be used when the temperature outside the hives is at least 3˚C.
Croatian: VMP Oxybee nakapava se na pčele u košnici, a treba ga primjenjivati kada je temperatura izvan košnice najmanje 3 ˚C.
English: Oxybee is a medicine used to treat varroosis in honey bee colonies.
Croatian: Oxybee je VMP koji se koristi za liječenje varooze u kolonijama medonosnih pčela.
English: The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći nakon primjene VMP-a prije nego što ljudi mogu konzumirati med.
English: Other information about Oxybee
Croatian: Ostale informacije o VMP-u Oxybee
English: Contact with these areas should be avoided, both directly and by hand-to-mouth or hand-to-eye contact.
Croatian: Treba izbjegavati izravan kontakt s tim dijelovima tijela, kao i kontakt usta ili očiju s rukom.
English: Oxybee oxalic acid
Croatian: Oxybee oksalna kiselina
English: Oxybee is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Croatian: VMP Oxybee dostupan je kao prah i otopina za pripremu disperzije za košnice (tekućina za korištenje unutar košnice) i može se dobiti bez veterinarskog recepta.
English: What are the risks associated with Oxybee?
Croatian: Koji su rizici povezani s VMP-om Oxybee?
English: Oxybee can only be used on colonies without brood.
Croatian: VMP Oxybee može se primjenjivati samo u kolonija bez legla.
English: How oxalic acid works on mites is not well understood but is thought to be due to the acidity of the medicine, which kills the mites on contact.
Croatian: Način djelovanja oksalne kiseline na grinje nije u potpunosti poznat, ali smatra se da djeluje zbog kiselosti i ubija grinje u dodiru s VMP-om.
English: The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees; the mite can also help spread viruses and bacteria.
Croatian: Grinje varoe hrane se hemolimfom (krv) odraslih pčela i leglom (razvojna faza medonosne pčele) što rezultira oštećenjem i/ili smrću pčela.
English: Oxybee contains the active substance oxalic acid.
Croatian: VMP Oxybee sadržava djelatnu tvar oksalnu kiselinu.
English: For practical information about using Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Oxybee vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: How does Oxybee work?
Croatian: Kako djeluje Oxybee?
English: For more information about treatment with Oxybee, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Oxybee vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno obratiti se svojem veterinaru ili ljekarniku.
English: How is Oxybee used?
Croatian: Kako se Oxybee koristi?
English: What benefits of Oxybee have been shown in studies?
Croatian: Koje su koristi od VMP-a Oxybee utvrđene u ispitivanjima?
English: The European Commission granted a marketing authorisation valid throughout the EU for Oxybee on 1 February 2018.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Oxybee na snazi u
English: March 2025
Croatian: Ožujak 2025.
English: These studies however, are of limited relevance.
Croatian: Međutim, ta su ispitivanja od ograničene važnosti.
English: Difference in changes
Croatian: Razlika u promjenama
English: It is important to initiate treatment as early as possible.
Croatian: Važno je početi liječenje što je prije moguće.
English: • Educational material for Healthcare Professionals
Croatian: • Edukativni materijal za zdravstvene radnike
English: Elderly patients (≥ 65 years old)
Croatian: Posebne populacije Stariji bolesnici (≥ 65 godina starosti)
English: ATC code: A16AB12.
Croatian: ATK oznaka: A16AB12
English: No differences in the safety profile were observed.
Croatian: Nisu primijećene razlike u sigurnosnom profilu.
English: The treatment benefit to the child compared to the associated risks must be fully evaluated prior to treatment.
Croatian: Korist od liječenja za dijete u usporedbi s povezanim rizicima mora se u potpunosti evaluirati prije liječenja.
English: These problems can be a part of the disease and may be caused by pressure on your spinal cord.
Croatian: Ti problemi mogu biti dio bolesti i mogu biti uzrokovani pritiskom na leđnu moždinu.
English: It is not known whether elderly patients respond differently from younger patients.
Croatian: Nije poznato imaju li stariji bolesnici drugačiji odgovor na lijek od mlađih bolesnika.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: - Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: The posology in the paediatric population is the same as in adults.
Croatian: Doziranje kod pedijatrijske populacije je isto kao i kod odraslih osoba.
English: The educational material for Healthcare Professionals should be a step by step dosing and administration guide that includes information on the following key elements:
Croatian: Edukativni materijal za zdravstvene radnike treba biti korak po korak vodič za doziranje i primjenu koji sadrži informacije o sljedećim ključnim elementima:
English: The current medical standards for emergency treatment are to be followed.
Croatian: Potrebno je slijediti postojeće medicinske standarde za hitno liječenje.
English: The educational pack should contain the following:
Croatian: Edukativni paket treba sadržavati sljedeće:
English: Submission of final study report:
Croatian: Dostavljanje završnog izvješća ispitivanja:
English: Safety and pharmacodynamic results in these patients are consistent with results observed in the first 52 weeks (see section 4.8).
Croatian: Sigurnosni i farmakodinamički rezultati u ovih ispitanika u skladu su s rezultatima uočenim u prva 52 tjedna (vidjeti dio 4.8).
English: What Vimizim is and what it is used for
Croatian: Što je Vimizim i za što se koristi
English: The safety and efficacy of Vimizim in patients older than 65 years has not been established, and no alternative treatment regimen can be recommended in these patients.
Croatian: Sigurnost i djelotvornost lijeka Vimizim kod bolesnika starijih od 65 godina nisu ustanovljene i za njih ne postoje preporučeni alternativni režimi liječenja.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Croatian: Učestalost se definira kao: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Aseptic technique is to be used.
Croatian: Potrebno je primijeniti aseptičku tehniku.
English: - If you have an allergic reaction during your infusion your doctor may slow down, or stop your infusion.
Croatian: - Ako imate alergijsku reakciju tijekom infuzije, Vaš liječnik može usporiti ili zaustaviti infuziju.
English: Vimizim should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
Croatian: Vimizim se ne smije miješati s drugim lijekovima u istoj infuziji osim onih navedenih niže.
English: • the risk of anaphylaxis and of severe allergic reactions and the measures necessary to minimise it:
Croatian: • rizik od anafilaksije i teških alergijskih reakcija i mjere koje su potrebne kako bi se on smanjio:
English: Date of first authorisation: 28 April 2014 Date of last renewal:
Croatian: Datum prvog odobrenja: 28. travnja 2014.
English: There are no data on the use of Vimizim in pregnant women.
Croatian: Nema podataka o upotrebi Vimizima kod trudnica.
English: The total volume of the infusion should be delivered over approximately 4 hours (see Table 1).
Croatian: Ukupna količina infuzije mora se dati u vremenu od otprilike 4 sata (vidjeti Tablicu 1).
English: This medicine may improve the symptoms of MPS IVA.
Croatian: Ovaj lijek može poboljšati simptome MPS IV A.
English: Due to lack of human data, Vimizim should only be administered to breast-feeding woman if the potential benefit is considered to outweigh the potential risk to the infant.
Croatian: Zbog nedostatka podataka kod ljudi, Vimizim se može dati ženi dojilji samo ako se smatra da potencijalne koristi premašuju potencijalni rizik za dijete.
English: You should not receive Vimizim during pregnancy unless clearly necessary.
Croatian: Ne biste trebali primati Vimizim za vrijeme trudnoće osim ako je jasno neophodan.
English: As a result, these substances do not get broken down and processed by the body as they should.
Croatian: Posljedično tome, te se specifične tvari ne razlažu i ne prerađuju u tijelu kako bi trebale.
English: Treatment has been shown to improve walking and to reduce the levels of keratan sulphate in the body.
Croatian: Liječenje je pokazalo poboljšanje hodanja i smanjenje razine keratan sulfata u tijelu.
English: The evaluation of the peri- and postnatal development study in rats is hampered due to subsequent administration of DPH, and therefore of limited relevance.
Croatian: Procjena peri- i postnatalnih razvojnih ispitivanja kod štakora otežana je radi naknadnog davanja DPH te je prema tome ograničenog značaja.
English: Total infusion volume (ml)
Croatian: Ukupni volumen infuzije (ml)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vimizim in one or more subsets of the paediatric population in MPS IVA.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja Vimizima u jednoj ili više podskupina pedijatrijske populacije s MPS IV A.
English: Tell your doctor if you feel dizzy after your infusion, especially before driving or using any machine where dizziness might be dangerous.
Croatian: Recite Vašem liječniku ako osjetite omaglicu nakon vaše infuzije, osobito prije upravljanja bilo kakvim strojevima prilikom čega omaglica može biti opasna.
English: If you experience such a reaction, you should immediately contact your doctor.
Croatian: Ako iskusite takvu reakciju, odmah se javite svom liječniku.
English: What you need to know before you are given Vimizim 3.
Croatian: Što morate znati prije nego počnete primati Vimizim 3.
English: The primary and secondary endpoints were evaluated at Week 24 (see Table 3).
Croatian: Primarne i sekundarne mjere ishoda procijenjene su u 24. tjednu (vidjeti Tablicu 3).
English: From a microbiological safety point of view, the diluted solution should be used immediately.
Croatian: S gledišta mikrobiološke sigurnosti, razrijeđena otopina mora se odmah upotrijebiti.
English: Patients continued a long-term follow-up observational study for at least another 52 weeks, for a total of 104 weeks.
Croatian: Ispitanici su nastavili sudjelovati u dugoročnom opservacijskom ispitivanju zasnovanom na praćenju od najmanje dodatna 52 tjedna, u ukupnom trajanju od 104 tjedna.
English: If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine unless discussed with your doctor.
Croatian: Ako Vi (ili Vaše dijete) imate nasljedno nepodnošenje fruktoze, rijedak genetski poremećaj, Vi (ili Vaše dijete) ne smijete primiti ovaj lijek osim ako to nije dogovoreno s Vašim liječnikom.
English: Model-based mean‡ (95%CI) p-value
Croatian: Srednja vrijednost bazirana na modelu‡ (95% CI) p-vrijednost
English: Mean half-life (t1/2) increased from 7.52 minutes at Week 0 to 35.9 minutes at Week 22.
Croatian: Srednji poluvijek (t1/2) povećao se sa 7,52 minuta u 0. tjednu na 35,9 minuta u 22 tjednu.
English: Table 1: Recommended infusion volumes and rates*
Croatian: Tablica 1: Preporučeni volumeni i brzine infuzije*
English: Discuss with your doctor if the benefits of taking Vimizim are greater than the potential risk to your newborn while breast-feeding.
Croatian: Razgovarajte sa svojim liječnikom o tome jesu li koristi od uzimanja Vimizima veće od potencijalnih rizika za Vaše novorođenče tijekom dojenja.
English: BioMarin Pharmaceutical, Inc. Galli Drive Facility 46 Galli Drive
Croatian: Galli Drive Facility 46 Galli Drive
English: The majority of patients who received Vimizim during clinical studies were in the paediatric and adolescent age range (5 to 17 years).
Croatian: Većina ispitanika koja je primila Vimizim u kliničkim ispitivanjima pripadala je pedijatrijskoj i adolescentskoj populaciji (5 do 17 godina).
English: Medicinal products containing sorbitol/fructose given intravenously may be lifethreatening.
Croatian: Lijekovi koji sadrže sorbitol/fruktozu koji se daju intravenski mogu biti opasni po život.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryofoetal development (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala izravne ili neizravne štetne utjecaje na trudnoću ili embriofetalni razvoj (vidjeti dio 5.3).
English: Elosulfase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Croatian: Elosulfaza alfa je protein i očekuje se da će se metabolički razgraditi hidrolizom peptida.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Vimizim are provided with an Educational pack.
Croatian: Nositelj odobrenja treba osigurati da pri stavljanju lijeka u promet svi zdravstveni radnici koji će koristiti i/ili propisivati Vimizim dobiju edukativni paket.
English: The medicine has to be diluted before being given.
Croatian: Ovaj lijek je potrebno razrijediti prije davanja.
English: Each infusion will take approximately 4 hours.
Croatian: Svaka infuzija traje oko 4 sata.
English: Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with elosulfase alfa.
Croatian: Dugoročna ispitivanja na životinjama za procjenu karcinogeničnog potencijala ili ispitivanja za procjenu mutagenog potencijala nisu provedena za elosulfazu alfa.
English: Each vial of Vimizim is intended for single use only.
Croatian: Vimizima je namijenjena samo za jednokratnu upotrebu.
English: Do not heat or microwave vials.
Croatian: Bočice ne zagrijavati niti grijati u mikrovalnoj pećnici.
English: Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Croatian: Prije stavljanja lijeka u promet u svakoj državi članici, nositelj odobrenja dogovorit će se s nacionalnim nadležnim tijelom o sadržaju i obliku edukativnog programa.
English: Treatment should be supervised by a physician experienced in the management of patients with MPS IVA or other inherited metabolic diseases.
Croatian: Liječenje mora nadzirati liječnik iskusan u liječenju bolesnika s MPS IV A ili drugim nasljednim bolestima metabolizma.
English: If you experience any difficulty swallowing, talking, severe shortness of breath or wheezing, swelling of the face or lips, dizziness or weak pulse; these may represent symptoms of a severe allergic reaction and you should tell your doctor immediately.
Croatian: Ako primijetite bilo kakve poteškoće s gutanjem, pričanjem, teškim nedostatkom daha ili piskanje, oticanje lica ili usana, omaglicu ili slab puls; to može predstavljati simptome teške alergijske reakcije i odmah trebate obavijestiti liječnika.
English: Set up a MPS IVA disease Registry to assess the long term safety and efficacy of elosulfase alfa.
Croatian: Postavljanje MPS IV A registra bolesti kako bi se procijenila dugoročna sigurnost i djelotvornost elosulfaze alfa.
English: • the calculation of the dose and of the volume of infusion
Croatian: • izračun doze i volumena infuzije
English: It is not known whether elosulfase alfa is excreted in human breast milk, but systemic exposure via breast milk is not expected.
Croatian: Nije poznato izlučuje li se elosulfaza alfa u majčino mlijeko u ljudi, ali ne očekuje se sistemska izloženost putem majčinog mlijeka.
English: As a precautionary measure, it is preferable to avoid the use of Vimizim during pregnancy, unless clearly necessary.
Croatian: Kao mjera predostrožnosti, preporučuje se izbjegavati upotrebu Vimizima za vrijeme trudnoće, osim ako je neophodan.
English: Your doctor or nurse will give Vimizim to you by an infusion into a vein.
Croatian: Vaš liječnik ili medicinska sestra će Vam dati Vimizim intravenskom infuzijom.
English: Pharmacokinetic parameter
Croatian: Farmakokinetički parametri
English: The dose you receive is based on your body weight.
Croatian: Doza koju primate se računa na osnovu Vaše tjelesne težine.