FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Micardis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Micardis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In the treatment of essential hypertension, Micardis was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Croatian: U liječenju esencijalne hipertenzije, Micardis je bio djelotvorniji od placeba u snižavanju dijastoličkog krvnog tlaka i imao je slično djelovanje kao drugi antihipertenzivi.
English: Micardis must not be used in people who have severe liver problems or bile problems.
Croatian: Micardis se ne smije koristiti u osoba koje imaju ozbiljne probleme s jetrom ili žuči.
English: Hypotension may be more common in patients receiving Micardis to prevent cardiovascular problems.
Croatian: Hipotenzija se može pojaviti češće u bolesnika koji primaju lijek Micardis radi prevencije kardiovaskularnih problema.
English: The combination of the two medicines was no more effective than either medicine taken alone and was linked to an increased risk of side effects.
Croatian: Kombinacija tih dvaju lijekova nije bila djelotvornija ni od kojega od tih lijekova koji se uzimao kao monoterapija i povezana je s većim rizikom od nuspojava.
English: Micardis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Croatian: Micardis se također koristi radi sprječavanja kardiovaskularnih problema (problema sa srcem i krvnim žilama), primjerice srčanih ili moždanih udara.
English: A risk management plan has been developed to ensure that Micardis is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Micardis.
English: The active substance in Micardis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Telmisartan, djelatna tvar u lijeku Micardis, „antagonist je receptora angiotenzina II”, što znači da u tijelu blokira djelovanje hormona naziva angiotenzin II.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Croatian: Angiotenzin II snažan je vazokonstriktor (tvar koja sužava krvne žile).
English: What is the risk associated with Micardis?
Croatian: Koji su rizici povezani s lijekom Micardis?
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Micardis must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Croatian: U bolesnika s dijabetesom tipa 2 ili u bolesnika s umjerenim ili ozbiljnim oštećenjem bubrežne funkcije, Micardis se također ne smije primjenjivati u kombinaciji s lijekovima koji sadrže aliskiren (također se primjenjuje u liječenju esencijalne hipertenzije).
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Croatian: Bolesnici s blago ili umjereno smanjenom jetrenom funkcijom ne smiju primati doze veće od 40 mg na dan.
English: Side effects with Micardis are not common.
Croatian: Nuspojave lijeka Micardis nisu uobičajene.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Micardis, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Micardis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is Micardis?
Croatian: Što je Micardis?
English: For the prevention of cardiovascular problems, 80 mg Micardis once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Croatian: Za potrebe prevencije kardiovaskularnih problema, doza od 80 mg lijeka Micardis jednom na dan ispitivana je u jednom glavnom ispitivanju kojim je obuhvaćeno gotovo 26 000 bolesnika u dobi od 55 godina ili starijih koji su bolovali od bolesti srca ili arterijske bolesti, pretrpjeli moždani udar ili koji su bolovali od dijabetesa i bili izloženi visokom riziku od kardiovaskularnih problema.
English: The CHMP decided that Micardis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Micardis nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day.
Croatian: Bolesnici s ozbiljno smanjenom funkcijom bubrega trebaju primati manju početnu dozu od 20 mg jednom na dan.
English: In the prevention of cardiovascular problems, Micardis had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Croatian: U prevenciji kardiovaskularnih problema, Micardis je imao slično djelovanje kao ramipril, pri čemu je otprilike 17 % bolesnika preminulo, hospitalizirano zbog kardiovaskularnih problema ili pretrpjelo srčani ili moždani udar.
English: For the treatment of essential hypertension, the usual recommended dose of Micardis is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Croatian: Za potrebe liječenja esencijalne hipertenzije, uobičajena preporučena doza lijeka Micardis iznosi 40 mg jednom na dan, no u nekih se bolesnika može zabilježiti pozitivan učinak već pri dozi od 20 mg jednom na dan.
English: For the treatment of essential hypertension, Micardis has been studied in 2,647 patients who took Micardis either alone or in combination with hydrochlorothiazide.
Croatian: Za potrebe liječenja esencijalne hipertenzije, Micardis je ispitivan na 2647 bolesnika koji su uzimali lijek Micardis kao monoterapiju ili u kombinaciji s hidroklorotiazidom.
English: The doctor should monitor the patient's blood pressure closely when starting Micardis, and may decide to adjust the patient's blood pressure-lowering medication.
Croatian: Pri započinjanju terapije lijekom Micardis liječnik treba pomno pratiti krvni tlak bolesnika i može donijeti odluku o prilagodbi terapije za snižavanje krvnoga tlaka bolesnika.
English: What is Micardis used for?
Croatian: Za što se Micardis koristi?
English: For the full list of all side effects reported with Micardis, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Micardis potražite u uputi o lijeku.
English: Micardis is used to treat essential hypertension (high blood pressure) in adults.
Croatian: Micardis se primjenjuje u liječenju esencijalne hipertenzije (visokog krvnog tlaka) u odraslih. „Esencijalne” znači da visok krvni tlak nije izazvan nijednim očitim uzrokom.
English: How does Micardis work?
Croatian: Kako djeluje Micardis?
English: What benefit has Micardis shown during the studies?
Croatian: Koje su koristi lijeka Micardis utvrđene u ispitivanjima?
English: How is Micardis used?
Croatian: Kako se Micardis koristi?
English: How has Micardis been studied?
Croatian: Kako je Micardis ispitivan?
English: It is available as capsules (50 and 150 mg).
Croatian: Dostupan je kao kapsule (50 i 150 mg).
English: It should also not be used in women who are breastfeeding, or who are pregnant (particularly during the first three months) unless it is clearly necessary.
Croatian: Ne smije se koristiti ni u žena koje doje ili koje su trudne (posebice tijekom prva tri mjeseca) osim ako nije potpuno neophodno.
English: The body is able to remove this salt from the cells.
Croatian: Tijelo može ukloniti ovu sol iz stanica.
English: EMA/CHMP/371429/2015 EMEA/H/C/000125
Croatian: EMA/429824/2013 EMEA/H/C/000125
English: The starting dose should be increased gradually over 4 to 6 weeks.
Croatian: Početnu dozu treba povećavati postupno tijekom razdoblja od 4 do 6 tjedana.
English: This summary was last updated in 07-2013.
Croatian: Sažetak je posljednji put ažuriran u 07.2013.
English: The maximum dose should never exceed 1.95 g per m2 per day.
Croatian: Maksimalna doza ne smije premašiti 1,95 g po m2 po danu.
English: Cystagon mercaptamine
Croatian: Cystagon merkaptamin
English: These studies included children and newly recruited patients in whom two different doses were tested.
Croatian: Ta su ispitivanja uključivala djecu i novoregrutirane bolesnike u kojih su testirane dvije različite doze.
English: It also improves survival and growth rate in the children treated.
Croatian: Također poboljšava preživljenje i stopu rasta u liječene djece.
English: Cystine levels in white blood cells should be monitored and used to adjust the dose.
Croatian: Koncentracije cistina u bijelim krvnim stanicama treba pratiti i koristiti za potrebe prilagodbe doze.
English: Because the disease is very serious, it was not possible for ethical reasons to compare Cystagon directly to placebo (a dummy treatment).
Croatian: Budući da je bolest vrlo ozbiljna, iz etičkih razloga nije bilo moguće usporediti lijek Cystagon izravno s placebom (liječenjem bez djelatne tvari).
English: The amount of cystine in the organs is therefore reduced, and this limits the damage to these organs.
Croatian: Količina cistina u organima stoga se smanjuje, čime se ograničava njihovo oštećenje.
English: Cystagon has been investigated in three main studies including 234 patients over a 12-year period.
Croatian: Cystagon je istražen u tri glavna ispitivanja koja su obuhvatila 234 bolesnika starija od 12 godina.
English: Starting doses should be one quarter to one sixth of the final expected doses.
Croatian: Početna doza treba odgovarati količini od jedne šestine do jedne četvrtine konačne očekivane doze.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cystagon on 23 June 1997.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Cystagon na snazi u Europskoj uniji od 23. lipnja 1997.
English: Cystinosis is a rare, fatal disease, and Cystagon is considered a useful medicine for this disease.
Croatian: Cistinoza je rijetka, smrtonosna bolest, a Cystagon se smatra korisnim lijekom za tu bolest.
English: Other information about Cystagon
Croatian: Ostale informacije o lijeku Cystagon
English: For children up to the age of 12 years, the recommended daily dose is calculated according to body surface area (which is calculated from the patient's height and weight), as 1.30 g per m2 divided into 4 doses.
Croatian: Kod djece do 12 godina, preporučena dnevna doza određuje se u odnosu na tjelesnu površinu (koja se izračunava na temelju visine i težine bolesnika), i to 1,30 g po m2 podijeljeno u 4 doze.
English: For patients over the age of 12 and over 50 kg in weight, the recommended daily dose is 2 g divided into 4 doses.
Croatian: Kod bolesnika starijih od 12 godina i težih od 50 kg, preporučena dnevna doza iznosi 2 g podijeljena u 4 doze.
English: This is a summary of the European public assessment report (EPAR) for Cystagon.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Cystagon.
English: The most common side effects with Cystagon (seen in more than 1 patient in 10) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Croatian: Najčešće nuspojave lijeka Cystagon (uočene u više od 1 bolesnika na 10) su gubitak apetita, povraćanje, mučnina (osjećaj slabosti), proljev, letargija (manjak energije) i pireksija (vrućica).
English: The comparison was done instead with a group of patients who had been treated with a dummy treatment as part of another, unrelated trial.
Croatian: Umjesto toga, usporedba je napravljena s grupom bolesnika koja je liječena bez djelatne tvari u sklopu drugog nepovezanog ispitivanja.
English: Cystinosis is a rare inherited disease in which excess amounts of cystine, an amino acid naturally found in the body, build up within cells, especially in the kidneys and the eyes, damaging them.
Croatian: Cistinoza je rijetka nasljedna bolest kod koje se prekomjerne količine cistina, aminokiseline koja se prirodno nalazi u tijelu, nakupljaju unutar stanica, posebice u bubrezima i očima, pritom ih oštećujući.
English: Cystagon treatment should be started by a doctor who has experience in the treatment of cystinosis.
Croatian: Terapiju lijekom Cystagon treba započeti liječnik koji ima iskustva u liječenju cistinoze.
English: Cystagon EMA/CHMP/371429/2015
Croatian: Cystagon EMA/429824/2013
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cystagon.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Cystagon.
English: The three studies showed that Cystagon delays kidney problems and the need for dialysis or renal transplantation, when treatment is started at an early age.
Croatian: Navedenim trima ispitivanjima dokazano je da Cystagon odgađa probleme s bubrezima te potrebu za dijalizom ili transplantacijom bubrega ako terapija započne u ranoj dobi.
English: The studies looked at the kidney function, the survival and the growth rate of the patients.
Croatian: Ispitivanjima je istražena funkcija bubrega, preživljenje i stopa rasta bolesnika.
English: Cystagon must not be used in people who are hypersensitive (allergic) to cysteamine or any of the other ingredients, or to another medicine called penicillamine.
Croatian: Cystagon se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na cisteamin ili na bilo koju drugu pomoćnu tvar ili bilo koji drugi lijek naziva penicilamin.
English: Cystagon is a medicine containing the active substance mercaptamine (also known as cysteamine).
Croatian: Cystagon je lijek koji sadrži djelatnu tvar merkaptamin (također poznat pod nazivom cisteamin).
English: What is the risk associated with Cystagon?
Croatian: Koji su rizici povezani s lijekom Cystagon?
English: The CHMP decided that Cystagon's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Cystagon nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is Cystagon?
Croatian: Što je Cystagon?
English: The full EPAR for Cystagon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Cystagon pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The active substance in Cystagon, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Croatian: Djelatna tvar lijeka Cystagon, merkaptamin, reagira s cistinom i pritom se stvara druga aminokiselina naziva cistein te spoj naziva cistein-cisteaminska sol.
English: Why has Cystagon been approved?
Croatian: Zašto je lijek Cystagon odobren?
English: Cystagon is used in patients who have nephropathic (kidney) cystinosis.
Croatian: Cystagon se koristi u bolesnika koji imaju nefropatsku (bubrežnu) cistinozu.
English: What benefit has Cystagon shown during the studies?
Croatian: Koje su koristi lijeka Cystagon dokazane u ispitivanjima?
English: What is Cystagon used for?
Croatian: Za što se Cystagon koristi?
English: How does Cystagon work?
Croatian: Kako djeluje Cystagon?
English: For the full list of all side effects reported with Cystagon, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Cystagon potražite u uputi o lijeku.
English: How is Cystagon used?
Croatian: Kako se Cystagon koristi?
English: How has Cystagon been studied?
Croatian: Kako je Cystagon ispitivan?
English: CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Croatian: CZ-281 63 Kostelec nad Cernymi lesy Republika Češka
English: 7.5 micrograms**
Croatian: 7,5 mikrograma**
English: In such cases, the Western Blot method is negative.
Croatian: U takvim je slučajevima metoda Western Blot negativna.
English: • you have a severe infection with a high temperature (over 38 °C).
Croatian: • ako imate tešku infekciju s visokom temperaturom (iznad 38°C).
English: What you need to know before you receive Celvapan
Croatian: Što morate znati prije nego primite Celvapan
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovo cjepivo jer sadrži Vama važne podatke.
English: Store in the original package in order to protect from light.
Croatian: Čuvati u originalnom pakovanju radi zaštite od svjetlosti.
English: SPECIAL STORAGE CONDITIONS Store in refrigerator.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku.
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Croatian: Međutim, dokazana je kemijska i fizikalna stabilnost tijekom primjene u trajanju od 3 sata pri sobnoj temperaturi.
English: Ask your pharmacist what to do with medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: • If a specific notification system has been put in place, how to report adverse
Croatian: • Ako je potrebno uspostaviti poseban sustav obavještavanja, kako prijaviti
English: This leaflet was last revised in {month/YYYY}
Croatian: Ova uputa je zadnji puta revidirana u {mjesec/GGGG}.
English: This is because the vaccination may not be recommended, or may need to be delayed.
Croatian: To je potrebno jer cijepljenje možda neće biti preporučeno ili će ga možda trebati odgoditi.
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: System Organ Class (SOC)
Croatian: Organski sustav (SOC)
English: For further information, see sections 4.8 and 5.1.
Croatian: Za dodatne informacije, vidjeti dio 4.8 i 5.1.
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući lijekove dobivene bez recepta, ili ako ste nedavno primili bilo koje drugo cjepivo.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Croatian: Ako se prethodno navedeno odnosi na Vas, cijepljenje će obično biti odgođeno dok se ne budete osjećali bolje.
English: What Celvapan is and what it is used for 2.
Croatian: Što je Celvapan i za što se koristi 2.
English: 21 Days After
Croatian: 21 dan kasnije
English: What Celvapan is and what it is used for
Croatian: Što je Celvapan i za što se koristi
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Croatian: Vaš liječnik ili medicinska sestra dat će cjepivo u skladu sa službenim preporukama.
English: • you are having a blood test to look for evidence of infection with certain viruses.
Croatian: • ako ste podvrgnuti krvnim pretragama radi traženja dokaza o infekciji određenim virusima.
English: Generalised skin reactions
Croatian: Generalizirane kožne reakcije
English: Tell the doctor requesting these tests that you have recently been given Celvapan.
Croatian: Recite liječniku koji traži te pretrage da ste nedavno primili Celvapan.
English: In the first few weeks after vaccination with Celvapan the results of these tests may not be correct.
Croatian: U prvih nekoliko tjedana nakon cijepljenja cjepivom Celvapan rezultati testiranja možda neće biti točni.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Croatian: Liječnici su svjesni te mogućnosti i imaju hitnu terapiju koja je dostupna za uporabu u takvim slučajevima.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima.
English: • Safety and immunogenicity data in special risk groups (immunocompromised and
Croatian: • Podatke o sigurnosti i imunogenosti za posebne rizične skupine (imunokompromitirane
English: This is a multidose container.
Croatian: Ovo je višedozni spremnik.
English: A minor infection such as a cold should not be problem, but your doctor or nurse should advise whether you could still be vaccinated with Celvapan.
Croatian: Manja infekcija kao što je prehlada ne bi trebala biti problem, no liječnik ili medicinska sestra bi Vas trebali savjetovati možete li primiti Celvapan.
English: Day 181
Croatian: 181. dan
English: A protective response may not be elicited in all vaccinees (see section 5.1).
Croatian: Zaštitna reakcija možda neće biti izazvana u svih cjepljenika (vidjeti dio 5.1).
English: • Safety and immunogenicity data in healthy adults, including older people.
Croatian: • Podatke o sigurnosti i imunogenosti u zdravih odraslih osoba, uključujući starije osobe.
English: Results from Vaccine Effectiveness Study in Jersey
Croatian: Rezultati ispitivanja učinkovitosti cjepiva u Jerseyu
English: Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Croatian: Takve su se reakcije pojavile i u pacijenata s anamnezom multiplih alergija i u pacijenata bez poznatih alergija.
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Croatian: Međutim, ako se to ne može izbjeći, cjepiva se treba injicirati u odvojene udove.
English: The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant
Croatian: Sigurnost Celvapana tijekom trudnoće i dojenja ispitana je na ograničenom broju trudnica.
English: No case of overdose has been reported.
Croatian: Nisu prijavljeni slučajevi predoziranja.
English: • The correct way to prepare the vaccine prior to administration.
Croatian: • Pravilan način pripreme cjepiva prije primjene.
English: 18 to 59 years
Croatian: 18 do 59 godina
English: Immunisation shall be postponed in patients with severe febrile illness or acute infection.
Croatian: Imunizacija će se odgoditi u pacijenata s teškom febrilnom bolesti ili akutnom infekcijom.
English: Other medicines and Celvapan
Croatian: Drugi lijekovi i Celvapan
English: • Safety and immunogenicity data obtained three weeks after administration of two doses of
Croatian: • Podatke o sigurnosti i imunogenosti dobivene tri tjedna nakon primjene dviju doza Celvapana
English: All subjects
Croatian: Svi ispitanici
English: After first opening, the product should be used immediately.
Croatian: Nakon prvog otvaranja, lijek je potrebno odmah primijeniti.
English: See section 4.4 for Special warnings and special precautions for use.
Croatian: Vidjeti dio 4.4 za Posebna upozorenja i posebne mjere opreza pri uporabi.
English: However, some differences in frequency and type of side effects were observed.
Croatian: Međutim, primijećene su određene razlike u učestalosti i vrsti nuspojava.
English: Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by influenza vaccines.
Croatian: Većina reakcija bila je blage naravi, kratkog trajanja i kvalitativno slična onima koje izazivaju cjepiva protiv influence.