FrancophonIA/ELRC3.0 huggingface dataset:
English: In a main study involving 43 patients with nephropathic cystinosis, there was no meaningful difference between the average levels of cystine in white blood cells during a 3-week treatment with the two medicines.
Croatian: U glavnom ispitivanju koje je uključivalo 43 bolesnika s nefrotskom cistinozom, nije bilo značajne razlike između prosječnih razina cistina u leukocitima tijekom trotjednog liječenja s dva lijeka.
English: It is not intended to provide practical advice on how to use Procysbi.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Procysbi.
English: Cystine levels in white blood cells (which are measured as nmol hemicystine per mg white blood cell protein), or alternatively mercaptamine concentration in the blood, should be monitored and used to adjust the dose, which should never exceed 1.95 g per m2 per day.
Croatian: Razine cistina u leukocitima (koje se mjere kao nmol hemicistina po mg proteina leukocita) ili alternativno koncentraciju merkaptamina u krvi treba nadzirati i koristiti kao bi se prilagodila koja nikad ne bi smjela premašiti 1,95 g po m2 na dan.
English: What measures are being taken to ensure the safe and effective use of Procysbi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Procysbi?
English: Procysbi must not be used in people who are hypersensitive (allergic) to any form of mercaptamine or any of the other ingredients, or to penicillamine.
Croatian: Procysbi ne smiju koristiti osobe koje su preosjetljive (alergične) na bilo koji oblik merkaptamina ili bilo koji drugi sastojak lijeka ili na penicilamin.
English: What is Procysbi and what is it used for?
Croatian: Što je Procysbi i za što se koristi?
English: The most common side effects with Procysbi (which may affect more than 1 in 10 people) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Croatian: Najčešće nuspojave s lijekom Procysbi (koje mogu zahvatiti više od na 10 osoba) su gubitak apetita, povraćanje, mučnina, proljev, letargija (manjak energije) i pireksija (vrućica).
English: Regarding its safety, the CHMP considered that the safety profile of mercaptamine is well established and the safety of Procysbi is expected to be similar to that of the reference medicine.
Croatian: Što se tiče njegove sigurnosti, CHMP je smatrao da je sigurnosni profil merkaptamina dobro utvrđen i da se očekuje da će sigurnost lijeka Procysbi biti slična onoj od referentnog lijeka.
English: The Committee also considered that the gastroresistant formulation, due to its less frequent administration, is expected to increase compliance with treatment and the quality of life of patients with cystinosis.
Croatian: Povjerenstvo je također smatralo da se očekuje da će gastrointestinalna formulacija, zbog rjeđe primjene, povećati pridržavanje s liječenje i kvalitetu života bolesnika s cistinozom.
English: Why is Procysbi approved?
Croatian: Zašto je Procysbi odobren?
English: Procysbi is a medicine that contains the active substance mercaptamine (also known as cysteamine).
Croatian: Procysbi je lijek koji sadrži djelatnu tvar merkaptamin (također poznatu i kao cisteamin).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Procysbi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Procysbi možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for Procysbi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku Procysbi (EPAR) može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with cystinosis is low, the disease is considered ‘rare', and Procysbi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 September 2010.
Croatian: Budući da je broj bolesnika s cistinozom mali, dotična se bolest smatra „rijetkom” te se Procysbi označava kao lijek za liječenje rijetkih i teških bolesti od 20. rujna 2010.
English: The reference medicine for Procysbi is Cystagon.
Croatian: Referentni lijek za Procysbi je Cystagon.
English: Procysbi given every 12 hours has been shown to be at least as effective as Cystagon given every 6 hours at maintaining the amount of cystine in white blood cells at acceptable levels (less than 1 nmol hemicystine per mg of white blood cell protein).
Croatian: Pokazalo se da je lijek Procysbi primijenjen svakih 12 sati barem učinkovit kao i Cystagon koji se daje svakih 6 sati za održavanje količine cistina u leukocitima na prihvatljivim razinama (manje od 1 nmol hemicistina po mg proteina leukocita).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Procysbi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Procysbi nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za korištenje u Europskoj uniji.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Procysbi, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju ovog plana sigurnosne informacije uključene su u Sažetak opisa svojstava lijeka i Uputu o lijeku za Procysbi uključujući i odgovarajuće mjere opreza kojih se trebaju pridržavati zdravstveni djelatnici i bolesnici.
English: The CHMP noted that Procysbi was shown to be at least as effective as Cystagon at maintaining the amount of cystine in white blood cells at acceptable levels.
Croatian: CHMP je napomenulo da je dokazano da je Procysbi barem jednako djelotvoran kao Cystagon u održavanju količine cistina u leukocitima na prihvatljivoj razini.
English: Other information about Procysbi
Croatian: Druge informacije o lijeku Procysbi
English: It must also not be used in women who are breastfeeding.
Croatian: Stoga se Procysbi također ne smije koristiti u žena koje su trudne.
English: What are the risks associated with Procysbi?
Croatian: Koji su rizici povezani s lijekom Procysbi?
English: For practical information about using Procysbi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Procysbi bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: The active substance in Procysbi, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Croatian: Djelatna tvar u lijeku Procysbi, merkaptamin reagira s cistinom kako bi tvorila drugu aminokiselinu, zvanu cistein i tvar zvanu sol cistein-cisteamina.
English: It is used in patients with nephropathic (kidney) cystinosis.
Croatian: Koriste se za bolesnike s nefropatskom (bubrežnom) cistinozom.
English: For more information about treatment with Procysbi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Procysbi pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What benefits of Procysbi have been shown in studies?
Croatian: Koje koristi lijeka Procysbi su dokazane u ispitivanjima?
English: How does Procysbi work?
Croatian: Kako djeluje Procysbi?
English: How is Procysbi used?
Croatian: Kako se Procysbi koristi?
English: For the full list of all side effects reported with Procysbi, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Procysbi potražite u uputi o lijeku.
English: Get medical help immediately.
Croatian: Odmah potražite liječničku pomoć.
English: Hepatitis that may be serious.
Croatian: Hepatitis koji može biti ozbiljan.
English: All comparisons against placebo were statistically significant.
Croatian: Sve usporedbe s placebom bile su statistički značajne.
English: This pack includes:
Croatian: Ovo pakiranje uključuje:
English: If you are unsure which level you are, choose Low activity.
Croatian: Ako niste sigurni na kojoj ste razini, odaberite slabu aktivnost.
English: Elderly (>65 years old)
Croatian: Stariji (≥65 godina)
English: The more active you are, the higher your calorie target.
Croatian: Što ste aktivniji to je ciljni broj kalorija veći.
English: Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
Croatian: Stoga je liječenje orlistatom potrebno započeti tek nakon pažljivog razmatranja mogućeg utjecaja na te bolesnike.
English: However, any possible risk should be avoided (see section 6.6).
Croatian: Ipak, svaki potencijalni rizik potrebno je izbjegavati (vidjeti dio 6.6).
English: Co. Waterford,
Croatian: Waterford,
English: The amount of weight you lose may vary from week to week.
Croatian: Koliko ćete dalje gubiti na težini može varirati od tjedna do tjedna.
English: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao liječnik ili ljekarnik.
English: sodium laurilsulfate, talc.
Croatian: natrijev laurilsulfat, talk.
English: See section 2, warnings and precautions.
Croatian: Pogledajte dio 2. Upozorenja i mjere opreza.
English: Not all pack sizes may be available in all countries.
Croatian: Ne moraju sva pakiranja biti dostupna u svim državama.
English: Stop taking the capsules.
Croatian: Prestanite uzimati kapsule.
English: Do not swallow them.
Croatian: Nemojte ih progutati.
English: Calories are a measurement of the energy your body needs.
Croatian: Kalorije su mjera energije koja je tijelu potrebna.
English: You should plan to have three meals per day.
Croatian: Trebate planirati uzimanje tri obroka dnevno.
English: Choose the level that most closely fits your daily routine.
Croatian: Odaberite razinu koja najbolje odgovara Vašoj svakodnevnoj rutini.
English: - Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Stop taking the tablets.
Croatian: Prestanite uzimati tablete.
English: Talk to your doctor about your risk of developing these conditions.
Croatian: Porazgovarajte s liječnikom o Vašem riziku od nastanka tih stanja.
English: Food diaries are effective, because they make you aware of what you are eating, how much you eat, and give you the basis to make changes.
Croatian: Dnevnici prehrane su učinkoviti jer Vam daju uvid u to što jedete, koliko jedete i omogućavaju da učinite potrebne promjene.
English: Choose your start date
Croatian: Odaberite datum početka
English: FURTHER HELPFUL INFORMATION
Croatian: Ostale korisne informacije
English: Find your height on the chart.
Croatian: Pronađite u tablici svoju visinu.
English: Some fatal cases or cases requiring liver transplantation have been reported.
Croatian: Prijavljeni su neki smrtni slučajevi ili slučajevi koji su zahtijevali transplantaciju jetre.
English: Date of first authorisation: 23rd July 2007.
Croatian: Datum prvog odobrenja: 23. srpnja 2007
English: Remember
Croatian: Upamtite
English: Eating fewer than 1200 calories per day is not recommended.
Croatian: Ne preporučuje se unos manje od 1200 kalorija na dan.
English: Date of latest renewal: 29th June 2017
Croatian: Datum posljednje obnove: 29. lipnja 2017
English: 4.5 Interaction with other medicinal products and other forms of interaction Ciclosporin
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Ciklosporin
English: The volume of distribution cannot be determined because the active substance is minimally absorbed and has no defined systemic pharmacokinetics.
Croatian: Distribucija Volumen distribucije ne može se odrediti jer se djelatna tvar minimalno apsorbira i nema definiranu sistemnu farmakokinetiku.
English: The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
Croatian: Vrijeme do postizanja potpunog izlučivanja (fecesom i urinom) iznosilo je 3 do 5 dana.
English: The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
Croatian: Dnevni unos masti, ugljikohidrata i proteina treba rasporediti na tri glavna obroka.
English: Animal studies do not indicate harmful effects with respect to fertility.
Croatian: Ispitivanja na životinjama ne pokazuju štetan učinak s obzirom na plodnost.
English: Approximately 97% of the administered dose was excreted in faeces and 83% of that as unchanged orlistat.
Croatian: Oko 97 % primjenjene doze izlučilo se u feces a od toga 83 % u obliku nepromijenjenog orlistata.
English: For further information about the alli weight loss programme visit <www.xxx.xxx>.
Croatian: Za daljnje informacije o alli programu za smanjenje tjelesne težine posjetitie <www.xxx.xxx>.
English: You may need to stop taking alli.
Croatian: Možda ćete trebati prestati uzimati alli.
English: Other medicines and alli alli may affect some medicines you have to take.
Croatian: Drugi lijekovi i alli alli može utjecati na neke lijekove koje morate uzimati.
English: - Low activity means you do little or no walking, climbing stairs, gardening, or other physical activity on a daily basis.
Croatian: - Slaba aktivnost znači da svakodnevno malo ili nimalo ne šećete, ne uspinjete se stubama, ne radite u vrtu, niti se bavite drugim tjelesnim aktivnostima.
English: Think about how much weight you want to lose and then set a target weight.
Croatian: Razmislite koliko kilograma želite izgubiti i potom odredite ciljnu tjelesnu težinu.
English: What you need to know before you take alli
Croatian: Što morate znati prije nego počnete uzimati alli
English: - if you are under 18 years old.
Croatian: • ako imate manje od 18 godina.
English: 24018, 1700 Λευκωσία
Croatian: Τ.Θ. 24018, 1700 Λευκωσία Tηλ.
English: - Successful weight loss is not just about eating differently for a short period of time before reverting to your old habits.
Croatian: - Uspješno smanjenje tjelesne težine ne znači samo drugačije jesti tijekom kratkog vremenskog razdoblja i potom se vratiti starim navikama.
English: Such diet-related treatment effects may be a signal that you have eaten more fat than you should have done.
Croatian: Ti učinci lijeka povezani s prehranom mogu biti znak da ste pojeli više masti nego što ste smjeli.
English: They generally occurred early in treatment (within 3 months) and most patients experienced only one episode.
Croatian: Općenito su se javljale u početnom razdoblju uzimanja lijeka (unutar 3 mjeseca) i u većine ispitanika javila se samo jedna epizoda.
English: The safety and efficacy of alli in children below 18 years of age has not been established.
Croatian: Sigurnost i djelotvornost lijeka alli u djece mlađe od 18 godina nisu ustanovljene.
English: • Whenever the risk management system is modified, especially as the result of new information being received that lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat zaprimanja novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: What alli looks like and contents of the pack
Croatian: Kako alli izgleda i sadržaj pakiranja
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, embrionalni/fetalni razvoj, porođaj ni na postnatalni razvoj (vidjeti dio 5.3).
English: Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours.
Croatian: Nastupi li znatno predoziranje orlistatom, preporučuje se promatrati osobu tijekom 24 sata.
English: If you eat a high-fat meal, do not take more than the recommended dose.
Croatian: Pojedete li obrok s mnogo masti, nemojte zato uzeti više od preporučene doze.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala i reproduktivne toksičnosti.
English: Effects seen in blood tests
Croatian: Učinci na nalaze krvnih pretraga
English: This medicine must not be taken by children and adolescents under 18 years old.
Croatian: Ovaj lijek ne smiju uzimati djeca i adolescenti ispod 18 godina starosti.
English: To see if your BMI is 28 or above, find your height on the chart.
Croatian: Da biste vidjeli je li Vaš indeks tjelesne mase 28 ili iznad, pronađite u tablici svoju visinu.
English: Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases.
Croatian: Orlistat je snažan, specifičan i dugodjelujući inhibitor gastrointestinalnih lipaza.
English: Take a multivitamin every day if you are taking alli - alli can lower the levels of some vitamins absorbed by your body.
Croatian: Svakodnevno uzimajte multivitaminske pripravak ako uzimate alli - alli može sniziti razine nekih vitamina koje Vaše tijelo apsorbira.
English: This could potentially lead to a decrease of immunosuppressive efficacy.
Croatian: To bi moglo smanjiti djelotvornost imunosupresije.
English: Height Weight
Croatian: Visina Težina
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107. (c) stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: See the chart further on in this section.
Croatian: Pogledajte tablicu niže u ovom dijelu.
English: This fat will pass out of the body in your stools (see section 4).
Croatian: Ta će se mast iz tijela odstraniti stolicom (pogledajte dio 4).
English: The clinical relevance of this effect in patients receiving amiodarone treatment remains unknown.
Croatian: Klinički značaj tog učinka u bolesnika koji primaju amiodaron nije poznat.
English: Wait and take the next capsule around your next main meal as usual.
Croatian: Pričekajte i iduću kapsulu uzmite uz sljedeći obrok, kao i obično.
English: This could be due to a decreased absorption of iodine salts and/or levothyroxine.
Croatian: To se može dogoditi zbog smanjene apsorpcije jodnih soli i/ili levotiroksina.
English: Orlistat minimally partitions into erythrocytes.
Croatian: Orlistat se minimalno raspodjeljuje u eritrocite.
English: If you weigh less than the weight shown for your height, your BMI is below 28 - do not use alli.
Croatian: Ako Vam je težina manja od one navedene uz Vašu visinu, Vaš BMI je ispod 28 - nemojte uzimati alli.
English: Make sure your three main meals are well balanced, reduced calorie, and lower-fat.
Croatian: Pobrinite se da ta tri glavna obroka budu dobro uravnotežena, te s manje kalorija i manje masti.
English: BMI is a way to find out if you have a healthy weight, or are overweight, for your height.
Croatian: ITM (BMI) pokazuje imate li zdravu tjelesnu težinu, ili je ona za Vašu visinu prekomjerna.
English: Although weight loss was assessed during 12 months of treatment in both studies, most weight loss occurred within the first 6 months.
Croatian: Premda se u oba istraživanja gubitak tjelesne težine pratio tijekom 12 mjeseci, glavnina tjelesne težine smanjila se unutar prvih 6 mjeseci.
English: 4.7 Effects on ability to drive and use machines Orlistat has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Orlistat nema utjecaj ili ima zanemariv utjecaj na sposobnost upravljanja vozilima i strojevima.
English: It is not known how frequently these effects occur (frequency cannot be estimated from the available data) - Increases in the levels of some liver enzymes.
Croatian: Nije poznato koliko se često ovi učinci javljaju (učestalost se ne može procijeniti iz dostupnih podataka) - Povišene razine nekih jetrenih enzima
English: The cumulative renal excretion of total orlistat-related materials was <2% of the given dose.
Croatian: Kumulativno izlučivanje ukupnog materijala povezanog s orlistatom putem bubrega iznosilo je < 2 % primjenjene doze.
English: Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
Croatian: Na temelju istraživanja u ljudi i životinja, svaki sistemski učinak koji se može pripisati inhibicijskom učinku orlistata na lipazu, brzo prolazi.
English: In vitro, orlistat is >99% bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
Croatian: In vitro se više od 99 % veže na proteine plazme (glavni vezujući proteini bili su lipoprotein i albumin).
English: Do not “save up” fat and calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on other weight loss programmes.
Croatian: Nemojte „štediti“ pri unosu masti i kalorija, a onda navaliti na obrok s mnogo masti ili na desert, kao što ste to možda činili ranije provodeći različite programe mršavljenja.
English: Comparison versus placebo: a p<0.001; b p<0.01
Croatian: Usporedba s placebom: a p<0,001; b p<0,01
English: These conditions may not cause you to feel unwell so you should see your doctor for a general health check.
Croatian: Ta stanja ne moraju uzrokovati da se osjećate loše, stoga trebate posjetiti liječnika i provjeriti svoje opće zdravstveno stanje.
English: Increase in transaminases and in alkaline phosphatase
Croatian: Povišene vrijednosti transaminaza i alkalne fosfataze
English: Upon discontinuation of therapy, faecal fat content returns to pre-treatment levels, usually within 48 to 72 hours.
Croatian: Po prekidu terapije, sadržaj masti u fecesu obično se vraća na razinu prije početka liječenja unutar 48 do 72 sata.
English: In the event of an overdose, medical advice should be sought.
Croatian: U slučaju predoziranja potrebno je potražiti savjet liječnika.
English: - You should aim to lose weight gradually and steadily.
Croatian: - Trebate nastojati da težinu smanjujete postupno i ravnomjerno.
English: This risk is increased in patients with underlying chronic kidney disease and/or volume depletion.
Croatian: Ovaj rizik povećan je u bolesnika s podležećom kroničnom bolesti bubrega i/ili deplecijom volumena.
English: Losing weight and maintaining weight loss, for example by improving your diet and increasing your physical activity, can help reduce the risk of serious health problems and help improve your health.
Croatian: Smanjenje tjelesne težine i njeno održavanje, npr. pravilnom prehranom i povećanom tjelesnom aktivnošću, može pomoći u smanjenju rizika od teških zdravstvenih problema i u poboljšanju zdravlja.
English: • Chronic malabsorption syndrome
Croatian: • Kronični malapsorpcijski sindrom
English: Anxiety†
Croatian: Anksioznost†