FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore concluded that the benefits of Methylphenidate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Croatian: CHMP je stoga zaključio da koristi Methylphenidate Sandoz nadmašuju njegove rizike i preporučio izdavanje odobrenja za stavljanje lijeka u promet u uključenim državama članicama.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Sandoz outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.
Croatian: Povjerenstvo Agencije za humane lijekove (CHMP) zaključilo je da koristi lijeka Methylphenidate Sandoz nadmašuju njegove rizike i da se odobrenje za stavljanje lijeka u promet, koje je dala Danska, može prihvatiti u drugim državama članicama EU-a.
English: The total dose for the whole day should be less than 100 mg per kilogram body weight.
Croatian: Ukupna doza za cijeli dan treba biti manja od 100 mg po kilogramu tjelesne težine.
English: It is available as tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).
Croatian: Dostupan je u obliku tableta (500 i 1000 mg) te kao oralna otopina (100 mg/ml).
English: Over time, the excess iron can damage important organs such as the heart and liver.
Croatian: Tijekom vremena višak željeza može oštetiti važne organe kao što su srce i jetra.
English: Further information on Ferriprox can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
Croatian: Više informacija o lijeku Ferriprox dostupno je na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
English: The usual dose of Ferriprox is 25 mg per kilogram body weight three times a day.
Croatian: Uobičajena doza lijeka Ferriprox iznosi 25 mg po kilogramu tjelesne težine triput dnevno.
English: Deferoxamine was given by injection under the skin overnight.
Croatian: Deferoksamin se davao tijekom noći injekcijom pod kožu.
English: The doctor may interrupt treatment if iron levels get too low.
Croatian: Liječnik može prekinuti liječenje ako razina željeza postane preniska.
English: This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.
Croatian: To je nasljedna bolest pri kojoj bolesnici ne mogu proizvoditi dovoljno hemoglobina, proteina u crvenim krvnim stanicama koji prenosi kisik kroz tijelo.
English: Less common but more serious side effects are agranulocytosis (very low levels of granulocytes, a type of white blood cell) and neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
Croatian: Rjeđe, ali ozbiljnije nuspojave su agranulocitoza (vrlo niska razina granulocita, vrste bijelih krvnih stanica) i neutropenija (niska razina neutrofila, vrste bijelih krvnih stanica koje se bore protiv infekcija).
English: • in combination with another iron chelator, when treatment with one iron chelator on its own does not work or when iron levels need to be rapidly or intensively corrected to prevent or treat lifethreatening conditions (mainly affecting the heart).
Croatian: • u kombinaciji s drugim kelatorom željeza, kada liječenje samo jednim kelatorom željeza nije uspješno odnosno kada je potrebna brza ili intenzivna korekcija razine željeza kako bi se spriječila ili izliječila stanja opasna po život (koja uglavnom pogađaju srce).
English: It attaches to iron in the body to form a compound that can be removed from the body, mainly in the urine, and to a lesser extent in the stools.
Croatian: Vezuje se na željezo u tijelu i stvara spoj koji se može izlučiti iz tijela, uglavnom kroz urin, a u manjoj mjeri kroz stolicu.
English: With repeated transfusions, the iron builds up because the body does not have a natural way of removing excess iron.
Croatian: Višestrukim transfuzijama željezo se nagomilava jer tijelo nema prirodan način za uklanjanje viška željeza.
English: The average blood ferritin levels were similar in the two treatment groups.
Croatian: Prosječne razine feritina u krvi bile su slične u obje liječene skupine.
English: The doctor may adjust the dose of Ferriprox according to how well the patient's iron levels are being controlled, which should be measured every 2 to 3 months with blood tests.
Croatian: Liječnik može prilagoditi dozu lijeka Ferriprox ovisno o tomu koliko se uspješno kontrolira razina željeza u krvi bolesnika, a to se treba provjeravati svaka dva do tri mjeseca krvnim pretragama.
English: Removing iron in this way helps to correct the iron overload and prevent damage from excess iron.
Croatian: Izlučivanjem željeza na taj način smanjuje se preopterećenje željezom i sprječavaju se oštećenja uslijed viška željeza.
English: • on its own, when standard iron chelator treatment cannot be used or does not work well enough;
Croatian: • kao monoterapija, kada standardno liječenje kelatorom željeza nije primjenjivo ili nije dovoljno uspješno;
English: Ferriprox is used:
Croatian: Ferriprox se koristi:
English: What measures are being taken to ensure the safe and effective use of Ferriprox?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ferriprox?
English: There were too few patients in the study to prove whether such a schedule is as effective as deferoxamine on its own.
Croatian: U ispitivanju je sudjelovalo premalo bolesnika da bi se dokazalo da je takav raspored jednako učinkovit kao monoterapija deferoksaminom.
English: The most common side effects with Ferriprox (which may affect more than 1 in 10 people) are redbrown urine (showing that iron is being removed through the urine), nausea (feeling sick), abdominal pain (stomach ache) and vomiting.
Croatian: Najčešće su nuspojave lijeka Ferriprox (koje se mogu javiti u više od 1 na 10 osoba) urin crvenosmeđe boje (što pokazuje da se željezo izlučuje putem urina), mučnina, abdominalni bol (bol u trbuhu) i povraćanje.
English: Transfused red cells bring iron into the body.
Croatian: Crvene krvne stanice primljene transfuzijom unose željezo u tijelo.
English: Ferriprox (deferiprone)
Croatian: Ferriprox (deferipron)
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ferriprox have also 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 Ferriprox nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: If the patient gets an infection, treatment with Ferriprox should be temporarily stopped and the neutrophil count checked more often.
Croatian: Ako bolesnik dobije infekciju, liječenje lijekom Ferriprox treba privremeno obustaviti i češće provjeravati broj neutrofila.
English: Side effects reported with Ferriprox are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ferriprox pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Ferriprox is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Croatian: Ferriprox je „kelator željeza” (tvar koja se veže na željezo) i koristi se za liječenje preopterećenja željezom (viška željeza u tijelu) u bolesnika s talasemijom major.
English: The company that markets Ferriprox must supply a reminder card for patients or their carers about the importance of regular tests for neutrophil counts, the need to watch out for symptoms of infection and for women to avoid becoming pregnant during treatment with Ferriprox.
Croatian: Tvrtka koja lijek Ferriprox stavlja u promet mora bolesnicima ili njihovim njegovateljima osigurati karticu s podsjetnikom o važnosti redovitih kontrola broja neutrofila, potrebi uočavanja simptoma infekcije kao i zaštite žena od trudnoće tijekom terapije lijekom Ferriprox.
English: Other information about Ferriprox
Croatian: Ostale informacije o lijeku Ferriprox
English: Ferriprox can only be obtained with a prescription and treatment should be started and continued by a doctor who has experience in the treatment of thalassaemia.
Croatian: Ferriprox se izdaje samo na recept, a terapiju mora započeti i provoditi liječnik koji ima iskustva u liječenju talasemije.
English: What is Ferriprox and what is it used for?
Croatian: Što je Ferriprox i za što se koristi?
English: The European Medicines Agency decided that Ferriprox's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Ferriprox nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Ferriprox was studied in 247 patients with thalassaemia major, aged over 6 years.
Croatian: Lijek Ferriprox ispitivan je na 247 bolesnika s talasemijom major starijih od šest godina.
English: Ferriprox received a marketing authorisation valid throughout the EU on 25 August 1999.
Croatian: Lijek Ferriprox dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 25. kolovoza
English: As for all medicines, data on the use of Ferriprox are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ferriprox kontinuirano se prate.
English: In another study involving 60 patients treated over 12 months, a combination of Ferriprox and deferoxamine (Ferriprox for 5 days plus deferoxamine for 2 days each week) was compared with deferoxamine on its own.
Croatian: U drugom ispitivanju kojim je bilo obuhvaćeno 60 bolesnika liječenih tijekom 12 mjeseci, kombinacija lijeka Ferriprox i deferoksamina (Ferriprox tijekom pet dana i deferoksamin dva dana svaki tjedan) uspoređena je s monoterapijom deferoksaminom.
English: An overview of Ferriprox and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ferriprox i zašto je odobren u EU-u
English: When taking Ferriprox, the patient's neutrophil count should be checked regularly (every week in the first year then less frequently).
Croatian: Tijekom primjene lijeka Ferriprox treba redovito provjeravati broj neutrofila u bolesnika (tijekom prve godine svaki tjedan, a kasnije rjeđe).
English: For more information about using Ferriprox, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Ferriprox pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Why is Ferriprox authorised in the EU?
Croatian: Zašto je lijek Ferriprox odobren u EU-u?
English: Ferriprox must not be used in women who are pregnant or breastfeeding.
Croatian: Ferriprox se ne smije koristiti u žena koje su trudne ili doje.
English: Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis.
Croatian: Osim toga, Ferriprox se ne smije primjenjivati s lijekovima koji bi mogli prouzročiti neutropeniju ili agranulocitozu.
English: The active substance in Ferriprox, deferiprone, is an iron chelator.
Croatian: Djelatna tvar u lijeku Ferriprox, deferipron, jest „kelator željeza”.
English: However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
Croatian: Međutim, čini se da se prosječna koncentracija željeza u jetri u bolesnika koji su primali lijek Ferriprox povećala više nego u onih koji su primali deferoksamin.
English: What are the risks associated with Ferriprox?
Croatian: Koji su rizici povezani s lijekom Ferriprox?
English: The main study involving 71 patients compared Ferriprox with deferoxamine, another iron chelator, over 2 years.
Croatian: U glavnom ispitivanju provedenom na skupini od 71 bolesnika lijek Ferriprox uspoređivan je s deferoksaminom, drugim kelatorom željeza, tijekom dvije godine.
English: Ferriprox must not be used in people who have had neutropenia repeatedly or agranulocytosis.
Croatian: Ferriprox se ne smije koristiti u osoba koje su u više navrata imale neutropeniju ili agranulocitozu.
English: Ferriprox contains the active substance deferiprone.
Croatian: Ferriprox sadrži djelatnu tvar deferipron.
English: In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.
Croatian: Objavljeni rezultati jednog ispitivanja primjene lijeka Ferriprox u kombinaciji s deferoksaminom upućuju i na veće smanjenje željeza u srcu u odnosu na bolesnike koji primaju samo deferoksamin.
English: In addition, published studies on Ferriprox together with deferoxamine reported greater reductions in blood ferritin levels when both medicines were used in combination compared with using either medicine on its own.
Croatian: Osim toga, objavljeni rezultati ispitivanja primjene lijeka Ferriprox u kombinaciji s deferoksaminom upućuju na to da se veća smanjenja razine feritina u krvi postižu kad se dva lijeka primjenjuju u kombinaciji u odnosu na monoterapiju jednim od lijekova.
English: What benefits of Ferriprox have been shown in studies?
Croatian: Koje su koristi od lijeka Ferriprox utvrđene u ispitivanjima?
English: How does Ferriprox work?
Croatian: Kako djeluje Ferriprox?
English: Blood ferritin levels were reduced to the same extent in patients treated with the combination as with deferoxamine on its own.
Croatian: Razine feritina u krvi smanjile su se u istoj mjeri u bolesnika koji su primali kombinaciju lijekova kao i u onih koji su primali samo deferoksamin.
English: The main measure of effectiveness was the change in the levels of ferritin in the blood.
Croatian: Glavno mjerilo učinkovitosti bila je promjena razine feritina u krvi, što je pokazatelj količine željeza koja se pohranjuje u tijelu.
English: For the full list of restrictions and side effects of Ferriprox, see the package leaflet.
Croatian: Potpuni popis ograničenja i nuspojava pri primjeni lijeka Ferriprox potražite u uputi o lijeku.
English: Patients should tell their doctor immediately if they have symptoms of an infection, such as fever, sore throat and flu-like symptoms.
Croatian: U slučaju pojave simptoma infekcije kao što su vrućica, grlobolja i simptomi nalik gripi, bolesnici o tomu trebaju odmah obavijestiti liječnika.
English: Median PFS was 11.9 months.
Croatian: Medijan PFS bio je 11,9 mjeseci.
English: It is not yet known how well it works in this age group.
Croatian: Još nije poznato koliko dobro djeluje u ovoj dobnoj skupini.
English: Just take your next dose at the usual time.
Croatian: Samo uzmite sljedeću dozu u uobičajeno vrijeme.
English: If you are going to have an operation
Croatian: Ako planirate ići na operaciju
English: Take Votrient at about the same time each day.
Croatian: Uzimajte Votrient svaki dan u približno isto vrijeme.
English: This is the maximum dose per day.
Croatian: To je maksimalna dnevna doza.
English: Moreover it should not be used in children younger than 2 years of age because of safety concerns.
Croatian: Nadalje, ne bi se smio koristiti u djece mlađe od 2 godine zbog sigurnosnih razloga.
English: Subgroup analyses of PFS were performed for 20 demographic and prognostic factors.
Croatian: Analiza podskupina PFS učinjena je za 20 demografskih i prognostičkih čimbenika.
English: If possible show them the pack, or this leaflet.
Croatian: Ako ste u mogućnosti, pokažite im pakiranje ili ovu uputu.
English: Votrient with food and drink
Croatian: Votrient s hranom i pićem
English: not known not known not known
Croatian: nepoznato nepoznato nepoznato
English: You may need extra tests to check that your heart and liver are working properly.
Croatian: Možda ćete trebati dodatne pretrage kako bi se provjerilo rade li Vaše srce i jetra kako treba.
English: The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost pazopaniba u djece u dobi od 2 do 18 godina nisu još ustanovljene.
English: Periodic testing should then continue after month 4.
Croatian: Nakon 4. mjeseca treba nastaviti s periodičkim testiranjem.
English: Votrient is not recommended for people aged under 18.
Croatian: Votrient se ne preporučuje mlađima od 18 godina.
English: Swallow the tablets whole with water, one after the other.
Croatian: Tablete progutajte cijele, s vodom, jednu po jednu.
English: Talk to your doctor about this.
Croatian: Razgovarajte sa svojim liječnikom o ovome.
English: Your doctor will decide whether Votrient is suitable for you.
Croatian: Vaš će liječnik odlučiti je li Votrient prikladan za Vas.
English: 09400 Aranda De Duero, Burgos Spain
Croatian: 09400 Aranda De Duero, Burgos Španjolska
English: - Tell your doctor if you have high blood pressure.
Croatian: - Recite svom liječniku ako imate visok krvni tlak.
English: This is known as a hypertensive crisis.
Croatian: To se zove hipertenzivna kriza.
English: This includes herbal medicines and other medicines you've bought without a prescription.
Croatian: To uključuje i biljne lijekove te druge lijekove koje ste kupili bez recepta.
English: - Tell your doctor if you are pregnant or planning to get pregnant.
Croatian: - Recite svom liječniku ako ste trudni ili namjeravate zatrudnjeti.
English: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly patients cannot be ruled out.
Croatian: Kliničko iskustvo ne pokazuje razliku u odgovoru starijih i mlađih bolesnika, no ne može se isključiti veća osjetljivost nekih starijih bolesnika.
English: What Votrient is and what it is used for
Croatian: Što je Votrient i za što se koristi
English: One subject did not recover and follow-up data were not available for the other 5 subjects.
Croatian: Jedan ispitanik se nije oporavio, a za drugih 5 podaci iz praćenja nisu dostupni.
English: Tell your doctor if you notice any change in your vision.
Croatian: Recite svom liječniku ako primijetite bilo kakvu promjenu u Vašem vidu.
English: When to take
Croatian: Kada uzimati
English: The following terms have been combined:
Croatian: Sljedeća su stanja združena:
English: The 95% confidence intervals for all subgroups include a hazard ratio of 1.
Croatian: Interval pouzdanosti od 95% za sve podskupine uključivao je omjer hazarda 1.
English: It works by preventing the activity of proteins that are involved in the growth and spread of cancer cells.
Croatian: Djeluje tako da sprječava aktivnost proteina koji su uključeni u rast i širenje stanica raka.
English: Pregnancy/ Contraception in males and females
Croatian: Trudnoća/ Kontracepcija u muškaraca i žena
English: Talk to your doctor before taking Votrient: - if you have heart disease.
Croatian: Obratite se svom liječniku prije nego uzmete Votrient: - ako imate bolest srca.
English: The other objectives were to evaluate the overall response rate and duration of response.
Croatian: Drugi su ciljevi bili procijeniti ukupnu stopu odgovora, te trajanje odgovora.
English: If you have high blood pressure you will be treated with medicines to reduce it.
Croatian: Ako imate visok krvni tlak, dobit ćete lijekove za njegovo snižavanje.
English: The following convention has been utilised for the classification of frequency: 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 the available data).
Croatian: Sljedeće dogovorene vrijednosti su korištene za klasifikaciju učestalosti: 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: A treatment decision should be made based on the assessment of individual patient's benefit/risk.
Croatian: Odluka o terapiji treba se temeljiti na individualnoj procjeni koristi/rizika za svakog bolesnika.
English: If you take more Votrient than you should
Croatian: Ako uzmete više lijeka Votrient nego što ste trebali
English: Don't take Votrient with food.
Croatian: Nemojte uzimati Votrient s hranom.
English: Your doctor will inform you of the results of the blood tests
Croatian: Vaš će Vas liječnik obavijestiti o nalazima krvnih pretraga.
English: The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines.
Croatian: Rizik od ovih nuspojava može biti veći kod ljudi koji već imaju problema sa srcem ili koji uzimaju druge lijekove.
English: High blood pressure and Votrient
Croatian: Visok krvni tlak i Votrient
English: Conditions you need to look out for
Croatian: Stanja o kojima trebate voditi računa
English: Date of first authorisation: 14 June 2010 Date of latest renewal: 08 January 2018
Croatian: Datum posljednje obnove odobrenja: 08. siječnja 2018.
English: Do not take Votrient - if you are allergic to pazopanib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Votrient - ako ste alergični na pazopanib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: OD - once daily
Croatian: JD - jednom dnevno
English: Votrient can raise your blood pressure.
Croatian: Votrient može povisiti Vaš krvni tlak.
English: PFS Overall* ITT
Croatian: PFS Sveukupno* ITT
English: Stop taking Votrient and seek medical help immediately if you develop hypertensive crisis.
Croatian: Prestanite uzimati Votrient i odmah potražite liječničku pomoć u slučaju razvoja hipertenzivne krize.
English: - Avoid driving or using machines if you feel dizzy, tired or weak, or if your energy levels are low.
Croatian: - Izbjegavajte upravljanje vozilom i korištenje strojeva ako osjećate omaglicu, ako ste umorni ili slabi te ako Vam je razina energije niska.
English: Tell your doctor if you notice any unusual changes in your heart beat, such as beating too fast or too slow.
Croatian: Recite svom liječniku ako primijetite bilo koje neuobičajene promjene u otkucajima srca, poput prebrzih ili presporih otkucaja srca.
English: No statistical differences were observed between treatment groups for Global Quality of Life using EORTC QLQ-C30 and EuroQoL EQ-5D.
Croatian: Između terapijskih skupina nije primijećena statistička razlika u globalnoj kvaliteti života prema EORTC QLQ-C30 i EuroQoL EQ-5D.
English: Not recommended
Croatian: Ne preporučuje se
English: Reproductive, fertility and teratogenic effects
Croatian: Plodnost, reproduktivni i teratogeni učinci
English: The film-coated tablets should be taken whole with water and not broken or crushed (see section 5.2).
Croatian: Filmom obložene tablete treba uzimati s vodom cijele, a ne razlomljene ili smrvljene (vidjeti dio 5.2).
English: Exposure at a 200 mg dose is markedly reduced, though highly variable, in these patients, with values considered insufficient to obtain a clinically relevant effect.
Croatian: Izloženost pri dozi od 200 mg je značajno smanjena, iako vrlo varijabilna, u ovih bolesnika s vrijednostma koje se smatraju nedovoljnima za postizanje klinički značajnog učinka.
English: A risk to the breast-fed child cannot be excluded.
Croatian: Ne može se isključiti rizik za dijete koje siše.
English: The following tumour types were not eligible:
Croatian: Sljedeći tipovi tumora nisu pogodni:
English: What you need to know before you take Votrient
Croatian: Što morate znati prije nego počnete uzimati Votrient
English: Other medicines and Votrient
Croatian: Drugi lijekovi i Votrient
English: What Votrient is and what it is used for What you need to know before you take Votrient How to take Votrient
Croatian: Što je Votrient i za što se koristi Što morate znati prije nego počnete uzimati Votrient Kako uzimati Votrient
English: Don't stop Votrient without advice Take Votrient for as long as your doctor recommends.
Croatian: Nemojte prekidati uzimanje lijeka Votrient bez savjeta Uzimajte Votrient toliko dugo dok Vam ga liječnik preporučuje.