FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose for each infusion is 4 mg per kilogram of body weight.
Croatian: Preporučena doza za svaku infuziju iznosi 4 mg po kilogramu tjelesne težine.
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Croatian: Svake godine Agencija procjenjuje sve nove informacije koje postanu dostupne te se ovaj sažetak po potrebi ažurira.
English: In 11 out of 12 patients, symptoms, including those affecting vision and movement, improved or did not get worse.
Croatian: U 11 od 12 bolesnika, simptomi, uključujući i one koji utječu na vid i kretanje, popravili su se ili se nisu pogoršali.
English: Mepsevii has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Mepsevii je odobren u „iznimnim okolnostima”.
English: Before the infusion the patient is given antihistamine treatment to reduce the risk of allergic reactions.
Croatian: Prije infuzije bolesnik dobiva terapiju antihistaminika kako bi se smanjio rizik od alergijskih reakcija.
English: Treatment should also be supervised by a healthcare professional with experience in the treatment of MPS VII.
Croatian: Terapiju također treba nadzirati zdravstveni radnik s iskustvom u liječenju MPS VII.
English: Mepsevii (vestronidase alfa)
Croatian: Mepsevii (vestronidaza alfa)
English: What is Mepsevii and what is it used for?
Croatian: Što je Mepsevii i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Mepsevii?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mepsevii?
English: This is because it has not been possible to obtain complete information about Mepsevii due to the rarity of the disease and for scientific reasons.
Croatian: Razlog tome je nemogućnost dobivanja potpunih informacija o lijeku Mepsevii zbog male učestalosti bolesti i iz znanstvenih razloga.
English: Since Mepsevii has been authorised under exceptional circumstances, the company that markets Mepsevii will conduct a study to provide data on the long-term effectiveness and safety of Mepsevii as well as on the disease itself, including its progression and development of symptoms.
Croatian: Budući da je lijek Mepsevii odobren u iznimnim okolnostima, tvrtka koja stavlja lijek Mepsevii u promet provest će studiju kako bi prikupila podatke o dugoročnom utjecaju i sigurnosti lijeka Mepsevii kao i o samoj bolesti, uključujući progresiju i razvoj simptoma.
English: Side effects reported with Mepsevii are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Mepsevii pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional who can manage medical emergencies.
Croatian: Lijek se izdaje samo na liječnički recept i treba ga primjenjivati odgovarajuće osposobljen zdravstveni radnik koji zna reagirati u hitnim medicinskim slučajevima.
English: Further information on Mepsevii can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Mepsevii možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In a main study of 12 patients with MPS VII, patients treated with Mepsevii for 6 months had a 65% reduction in their urine levels of GAGs.
Croatian: U glavnoj studiji provedenoj na 12 bolesnika s MPS VII, u bolesnika koji su primali lijek Mepsevii u trajanju od 6 mjeseci razina glikozaminoglikana u urinu smanjena je za 65 %.
English: Although only a limited amount of data is available from clinical studies, the European Medicines Agency took into account the life-threatening and debilitating nature of MPS VII and the lack of authorised medicines.
Croatian: Iako su iz kliničkih studija dostupni samo ograničeni podatci, Europska agencija za lijekove u obzir je uzela po život opasnu i iscrpljujuću prirodu MPS VII te nedostatak odobrenih lijekova.
English: Mepsevii must not be used in patients who have ever had anaphylactic reaction to vestronidase alfa or any of the other ingredients of the medicine.
Croatian: Mepsevii se ne smije davati bolesnicima koji su ikad imali anafilaktičku reakciju na vestronidazu alfa ili bilo koji drugi sastojak lijeka.
English: Mepsevii is given every two weeks as an infusion (drip) into a vein lasting 4 hours.
Croatian: Lijek Mepsevii primjenjuje se svaka dva tjedna intravenskom infuzijom (drip) u trajanju od 4 sata.
English: Why is Mepsevii authorised in the EU?
Croatian: Zašto je lijek Mepsevii odobren u EU-u?
English: The disease leads to build up of GAGs in the body, which causes a wide range of problems, including joint stiffness, short stature, enlarged liver and spleen, hearing loss, cataract and delays in development.
Croatian: Bolest dovodi do nakupljanja glikozaminoglikana u tijelu, što uzrokuje brojne probleme, uključujući ukočenost zglobova, niski rast, povećanu jetru i slezenu, gubitak sluha, mrenu i zakašnjeli razvoj.
English: Other information about Mepsevii
Croatian: Ostale informacije o lijeku Mepsevii
English: Mepsevii is a medicine to treat mucopolysaccharidosis type VII (MPS VII, also known as Sly syndrome), an inherited disease caused by a lack of an enzyme needed to break down complex carbohydrates known as glycosaminoglycans (GAGs).
Croatian: Mepsevii je lijek za liječenje mukopolisaharidoze tipa VII (MPS VII, poznate i kao Sly sindrom), nasljedne bolesti koju uzrokuje nedostatak enzima potrebnih za razgradnju složenih ugljikohidrata poznatih kao glikozaminoglikani.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mepsevii have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Mepsevii nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: As for all medicines, data on the use of Mepsevii are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Mepsevii kontinuirano se prate.
English: The most common side effects with Mepsevii (which may affect more than 1 in 10 people) are anaphylactic reaction (sudden, severe allergic reaction), urticaria (itchy rash) and swelling at the infusion site.
Croatian: Najčešće nuspojave lijeka Mepsevii (koje se mogu javiti u više od 1 na 10 osoba) su anafilaktička reakcija (nagla, jaka alergijska reakcija), urtikarija (koprivnjača) i oticanje na mjestu infuzije.
English: What are the risks associated with Mepsevii?
Croatian: Koji su rizici povezani s lijekom Mepsevii?
English: An overview of Mepsevii and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Mepsevii i zašto je odobren u EU-u
English: For more information about using Mepsevii, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Mepsevii pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: MPS VII is rare, and Mepsevii was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 March 2012.
Croatian: Mukopolisaharidoza je rijetka bolest, a Mepsevii je dobio status „lijeka za rijetku bolest” 21. ožujka 2012.
English: Mepsevii is an enzyme replacement therapy that works by replacing the missing enzyme (betaglucuronidase) in patients with MPS VII, helping to break down GAGs and stopping them building up in the body.
Croatian: Mepsevii je zamjenska enzimska terapija koja djeluje tako da zamjenjuje enzim koji nedostaje (betaglukoronidaza) u bolesnika s MPS VII, čime pomaže razgradnju glikozaminoglikana i zaustavlja njihovo nakupljanje u tijelu.
English: EMA decided that Mepsevii's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi lijeka Mepsevii nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Mepsevii contains the active substance vestronidase alfa.
Croatian: Mepsevii sadržava djelatnu tvar vestronidaza alfa.
English: In addition, most adverse reactions are mild to moderate in severity.
Croatian: Uz to, većina nuspojava je blaga.
English: Mepsevii has been shown to reduce the levels of GAGs in the body and reduce or stabilise symptoms in patients with MPS VII.
Croatian: Pokazalo se da lijek Mepsevii smanjuje razine glikozaminoglikana u tijelu i smanjuje ili stabilizira simptome u pacijenata s MPS VII.
English: What information is still awaited for Mepsevii?
Croatian: Koje se još informacije očekuju o lijeku Mepsevii?
English: Mepsevii reduces the levels of GAGs in the body and improves or at least stabilises the symptoms of MPS VII.
Croatian: Lijek Mepsevii smanjuje razine glikozaminoglikana u tijelu i popravlja ili barem stabilizira simptome MPS VII.
English: How is Mepsevii used?
Croatian: Kako se Mepsevii koristi?
English: What benefits of Mepsevii have been shown in studies?
Croatian: Koje su koristi lijeka Mepsevii dokazane u ispitivanjima?
English: How does Mepsevii work?
Croatian: Kako djeluje Mepsevii?
English: EU/1/96/026/002
Croatian: EU/1/96/026/002 Invirase
English: Oral use bottle (HDPE)
Croatian: Bočica (HDPE)
English: 500 mg Film-Coated tablet
Croatian: 500 mg Filmom obložena tableta
English: 120 filmcoated tablets
Croatian: 120 filmom obloženih tableta
English: Invented name Strength Pharmaceutical form
Croatian: Doza Farmaceutski oblik
English: Invirase
Croatian: Kroz usta
English: (Invented) name Strength Pharmaceutical Form
Croatian: Farmaceutski oblik
English: (Invented) name Strength Pharmaceutical form
Croatian: (Izmišljeni) naziv Jačina Farmaceutski oblik
English: MA (EU) number
Croatian: MA (EU) broj
English: Strength Pharmaceutical Form Route of Administration
Croatian: Doza Farmaceutski oblik Put primjene
English: 1 pre-filled syringe (non-blistered)
Croatian: 1 napunjena štrcaljka (bez blistera)
English: 1 pre-filled syringe (blistered)
Croatian: 1 napunjena štrcaljka (u blisteru)
English: 1 pre-filled syringe with automatic needle guard (blistered)
Croatian: 1 napunjena štrcaljka s štitnikom za iglu (u blisteru)
English: Invented name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Strength Pharmaceutical Form Route of Administration
Croatian: Doza Farmaceutski oblik
English: If you take more X than you should
Croatian: Ako uzmete više X nego što ste trebali
English: Take your medicine as soon as you remember.
Croatian: Uzmite svoj lijek čim se sjetite.
English: If you forget to take X
Croatian: Ako ste zaboravili uzeti X
English: Usually, the maximum treatment duration should not exceed one week.
Croatian: Obično, maksimalno trajanje liječenja ne smije biti dulje od jednog tjedna.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: The dose may also need to be reduced.
Croatian: Također može biti potrebno smanjiti dozu.
English: Do not take {Tradename} for longer than 7 days without consulting your doctor.
Croatian: Nemojte uzimati {Zaštićeno ime} dulje od 7 dana bez konzultacije sa svojim liječnikom.
English: Ask your doctor for advice before taking this medicine.
Croatian: Pitajte svog liječnika za savjet prije nego što uzmete ovaj lijek.
English: If convenient, a glass of water can be taken afterwards.
Croatian: Nakon toga se, po želji, može popiti čaša vode.
English: Symptoms usually resolve with 3-4 days of taking this medicine.
Croatian: Simptomi obično nestaju nakon 3-4 dana uzimanja ovog lijeka.
English: The above list of substances is representative and not exhaustive.
Croatian: Gore naveden popis tvari je reprezentativan i nije potpun.
English: Do not give more than 3 times in a 24 hour time period.
Croatian: Nemojte davati više od 3 puta unutar 24 sata.
English: Patients should try to take each dose at the scheduled time.
Croatian: Bolesnici se trebaju truditi uzimati svaku dozu u predviđeno vrijeme.
English: The dose is 0.25 mg/kg.
Croatian: Doza je 0,25 mg/kg.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacije o lijeku mogu naknadno revidirati nadležna tijela država članica, u suradnji s referentnom državom članicom,ako je potrebno, u skladu s postupcima propisanim u poglavlju 4. Glave III Direktive 2001/83/EZ.
English: • AIDS/HIV (protease inhibitors)
Croatian: • AIDS/HIV (inhibitori proteaze)
English: Do not take {Product Name} if you are taking medicine to treat:
Croatian: Nemojte uzimati {Naziv lijeka} ako uzimate lijek za liječenje:
English: When taken without water, the tablet should be placed on the tongue and dissolve in the mouth before swallowing.
Croatian: Kad se uzima bez vode, tabletu treba staviti na jezik i otopiti u ustima prije nego što se proguta.
English: The unbound fraction is increased by 25 %, and the terminal elimination half-life is prolonged from 15 to 23 hours.
Croatian: Slobodna frakcija je povećana za 25 %, a terminalno poluvrijeme eliminacije je produljeno od 15 na 23 sata.
English: No teratogenicity was observed in mice and rabbits
Croatian: Nije uočena teratogenost u miševa i kunića.
English: Domperidone should be used during breast feeding only if your physician considers this clearly necessary.
Croatian: Domperidon treba uzimati tijekom dojenja samo ako Vaš liječnik smatra da je to jasno neophodno.
English: Oral domperidone should be taken before meals/feeding.
Croatian: Peroralni domperidon treba se uzimati prije obroka/hranjenja.
English: The relevance of the latter study for humans following exposure to orally administered domperidone is uncertain.
Croatian: Važnost ovog posljednjeg ispitivanja za ljude nakon izloženosti peroralno primijenjenom domperidonu nije jasna.
English: Treatment with domperidone should be stopped.
Croatian: Liječenje domperidonom treba prekinuti.
English: - if you have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.
Croatian: - ako imate stanje koje uzrokuje nisku razinu kalija ili magnezija u krvi, ili pak visoku razinu kalija u krvi.
English: If you have used or taken too much {Tradename}, contact your doctor, pharmacist or the poison centre immediately, in particular if a child has taken too much.
Croatian: Ako ste koristili ili uzeli previše {Zaštićeno ime}, odmah se obratite svom liječniku, ljekarniku ili centru za kontrolu otrovanja, osobito ako je dijete uzelo previše lijeka.
English: Section 4.6 Fertility, pregnancy and lactation
Croatian: Dio 4.6 Plodnost, trudnoća i dojenje
English: If it is almost time for your next dose, wait until that is due and then continue as normal.
Croatian: Ako je uskoro vrijeme za sljedeću dozu, pričekajte do tog vremena i onda nastavite s uobičajenim uzimanjem.
English: Domperidone should be used at the lowest effective dose in adults and children.
Croatian: Domperidon treba uzimati u najnižoj djelotvornoj dozi za odrasle i djecu.
English: Section 3 ‘How to take X' [This section should be amended to include the below wording] Follow these instructions closely unless your doctor has advised you otherwise.
Croatian: Dio 3 “Kako uzimati X” [Ovaj dio treba izmijeniti tako da se uključi dolje navedeni tekst] Pomno slijedite ove upute, osim ako Vam je liječnik savjetovao drugačije.
English: In the event of overdose, symptomatic treatment could be implemented.
Croatian: U slučaju predoziranja, može se primijeniti simptomatsko liječenje.
English: Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heart beat) have been reported; if this happens, you should stop the treatment immediately.
Croatian: Poremećaji kardiovaskularnog sustava: prijavljeni su poremećaji srčanog ritma (brzi ili nepravilni otkucaji srca); ako se ovo dogodi, treba odmah prekinuti liječenje.
English: It is important to ask your doctor or pharmacist if {Tradename} is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Croatian: Važno je da pitate svog liječnika ili ljekarnika je li sigurno uzimati {Zaštićeno ime} kad uzimate bilo koji drugi lijek, uključujući lijekove koji se dobivaju bez recepta.
English: The orodispersible tablet dissolves rapidly in the mouth with the help of the saliva, and the can be taken with or without water.
Croatian: Raspadljiva tableta za usta se brzo otapa u ustima pomoću sline, a može se uzimati sa ili bez vode.
English: Section 4.4 Special warnings and precautions for use
Croatian: Dio 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: Oral Suspension/syrup
Croatian: Oralna suspenzija/sirup
English: If {Product name} is for a child, ask your doctor for the children's formulation.
Croatian: Ako je {Naziv lijeka} namijenjen djetetu, obratite se svom liječniku za farmaceutski oblik za djecu.
English: The risk also increases when domperidone is given together with some drugs.
Croatian: Rizik se također povećava kad se domperidon daje zajedno sa drugim lijekovima.
English: [For oral formulations]: It is recommended to take oral <X> before meals.
Croatian: [Za peroralne farmaceutske oblike]: Preporučuje se uyeti peroralni <X> prije obroka.
English: Tablets, Effervescent granules, Suppositories
Croatian: Tablete, šumeće granule, čepići
English: Section 4 Possible side effects
Croatian: Dio 4 Moguće nuspojave
English: A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Treba odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja domperidonom uzimajući u obzir koristidojenja za dijete i korist liječenja za ženu.
English: Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life.
Croatian: Ispitanici s blagim oštećenjem jetre imaju nešto nižu sistemsku izloženost nego zdravi ispitanici na osnovu Cmax i AUC, bez promjene u vezanju na proteine ili terminalnom poluvremenu.
English: Domperidone has been associated with prolongation of the QT interval on the electrocardiogram.
Croatian: Domperidon se povezuje s produljenjem QT intervala na elektrokardiogramu.
English: Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see section other medicines and X).
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate lijekove za liječenje infekcije (gljivične ili bakterijske infekcije) i/ili imate srčane tegobe ili AIDS/HIV (pogledajte dio drugi lijekovi i X).
English: It is advisable to ask your doctor for advice in case of prolonged treatment as you may need to take a lower dose or take this medicine less often, and your doctor may want to examine you regularly.
Croatian: Preporučuje se da se obratite svom liječniku za savjet u slučaju produljenog liječenja jer može biti potrebno smanjiti dozu ili uzimati ovaj lijek rjeđe, a možda će Vas i liječnik željeti redovito kontrolirati.
English: Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician.
Croatian: Liječenje domperidonom treba prekinuti ako se jave znakovi ili simtomi koji mogu biti povezani s aritmijom srca, a bolesnici se trebaju obratiti svom liječniku.
English: In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 3-fold.
Croatian: U prisustvu inhibicije metabolizma putem CYP3A4, koncentracije slobodnog domperidona u plazmi se mogu povisiti do 3 puta.
English: - if you are taking certain medicines (see “Taking other medicines”) Warnings and precautions
Croatian: - ako uzimate određene lijekove (pogledajte “Drugi lijekovi i X”)
English: [Orodispersible tablets]
Croatian: [Raspadljive tablete za usta]
English: [Oral suspension/syrup]
Croatian: [Oralna suspenzija/sirup]
English: Domperidone may cause unwanted side effects affecting the heart in a breast-fed baby.
Croatian: Domperidon može uzrokovati neželjene nuspojave koje utječu na srce dojenčeta.
English: Subjects with severe hepatic impairment were not studied.
Croatian: Ispitanici s teškim oštećenjem jetre nisu ispitivani.
English: Do not take more than 30 mg per day.
Croatian: Nemojte uzeti više od 30 mg na dan.
English: At a high maternally toxic dose (more than 40 times the recommended human dose), teratogenic effects were seen in the rat.
Croatian: Pri visoko toksičnoj dozi za ženke štakora (više od 40 puta većoj od preporučene doze za ljude) uočeni su teratogeni učinci u štakora.
English: Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk.
Croatian: Ne može se isključiti pojava nuspojava, naročito učinaka na srce, nakon izloženosti putem majčinog mlijeka.
English: If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed.
Croatian: Ako je doza po rasporedu propuštena, propuštena doza se treba izostaviti i nastaviti po uobičajenom rasporedu doziranja.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti <liječnika> <,><ili> <ljekarnika> <ili medicinsku sestru>.
English: Section 5.1 Pharmacodynamic properties
Croatian: Dio 5.1 Farmakodinamička svojstva
English: Although domperidone's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take domperidone 15 - 30 minutes before a meal.
Croatian: Iako je bioraspoloživost domperidona kod zdravih ispitanika povećana kad se uzima poslije obroka, bolesnici sa gastrointestinalnim tegobama trebaju uzimati domperidon 15 - 30 minuta prije obroka.
English: Domperidone is excreted in human milk and breast-fed infants receive less than 0.1 % of the maternal weight-adjusted dose.
Croatian: Domperidon se izlučuje u majčino mlijeko u ljudi, a dojenčad prima manje od 0,1 % majčine doze prilagođene tjelesnoj težini.
English: For example, for a child weighing 10 kg, the dose is 2.5 mg and this can be given three times per day to a maximum dose of 7.5 mg per day.
Croatian: Na primjer, za dijete težine 10 kg, doza je 2,5 mg i može se dati tri puta na dan do maksimalne doze od 7,5 mg na dan.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V*.
English: The usual dose is one suppository two times a day.
Croatian: Uobičajena doza je jedan čepić dva puta na dan.
English: Since very little unchanged drug (approximately 1%) is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency.
Croatian: Budući da se putem bubrega izluči vrlo malo nepromijenjenog lijeka (približno 1%), nije vjerojatno da se, u bolesnika sa bubrežnom insuficijencijom, doza kod jednokratne primjene treba prilagoditi.
English: • malaria (in particular halofantrine)
Croatian: • malarije (osobito halofantrin)
English: Cardiovascular effects
Croatian: Učinci na kardiovaskularni sustav
English: Due to the need for accurate dosing, tablets, effervescent granules and suppositories are unsuitable for use in children and adolescents weighing less than 35 kg.
Croatian: Zbog potrebe za točnim doziranjem, tablete, šumeće granule i čepići neprikladni su za uporabu u djece i adolescenata težine manje od 35 kg.