FrancophonIA/ELRC3.0 huggingface dataset:
English: However, MPA Cmax was decreased by 40 % in the presence of food.
Croatian: Međutim, MPA Cmax je u prisutnosti hrane smanjena za 40 %.
English: Your doctor will have to advise you on what vaccines you can have.
Croatian: Liječnik će Vas savjetovati o tome koja cjepiva možete primiti.
English: Talk to your doctor about the most suitable contraception for you.
Croatian: Razgovarajte sa svojim liječnikom o tome koja bi kontracepcija bila najbolja za Vas.
English: Do this by:
Croatian: Učinite to tako da:
English: Effects of hepatic disease on this process probably depend on the particular disease.
Croatian: Utjecaj jetrene bolesti na taj proces vjerojatno ovisi o određenoj bolesti.
English: • Do not take any capsules that have broken open or split.
Croatian: • Ne uzimajte kapsule koje su razlomljene ili odvojene.
English: This means you may catch more infections than usual.
Croatian: To znači da biste mogli biti podložniji infekcijama više nego inače.
English: Your doctor will do regular blood tests to check for any changes in
Croatian: Liječnik će Vas redovito slati na krvne pretrage kako bi provjerio eventualne promjene u:
English: Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies.
Croatian: Vaš će liječnik razgovarati s Vama i dati Vam pisane informacije, osobito o učincima mikofenolata na nerođenu djecu.
English: Myclausen reduces your body's defences.
Croatian: Myclausen oslabljuje obranu Vašeg tijela.
English: If you forget to take your medicine at any time, take it as soon as you remember.
Croatian: Ako u bilo koje doba zaboravite popiti svoj lijek, popijte ga čim se sjetite.
English: The need to plan a pregnancy will be highlighted.
Croatian: Naglasit će se potreba za planiranjem trudnoće.
English: • This belongs to a group of medicines called “immunosuppressants”.
Croatian: • Pripada skupini lijekova koji se nazivaju ”imunosupresivi”.
English: However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
Croatian: Međutim, strogi klinički nadzor treba biti proveden tijekom kombinacije i kratko nakon liječenja antibiotikom.
English: • using a sunscreen with a high protection factor.
Croatian: • upotrebljavate kremu za zaštitu od sunca s visokim zaštitnim faktorom.
English: If neutropenia develops (absolute neutrophil count < 1.3 x 10
Croatian: Ako se pojavi neutropenija (apsolutni broj neutrofila < 1,3 x 10
English: Do not stop taking Myclausen unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Myclausen osim ako Vam to ne kaže Vaš liječnik.
English: This includes medicines obtained without a prescription, including herbal medicines.
Croatian: To uključuje lijekove koji se mogu nabaviti bez recepta, uključujući biljne lijekove.
English: However, at high MPAG plasma concentrations (> 100 µg/mL), small amounts of MPAG are removed.
Croatian: Međutim, pri visokim koncentracijama MPAG-a u plazmi (> 100 µg/ml) uklonjene su male količine MPAG-a.
English: Store below 30 °C.
Croatian: Čuvati na temperaturi ispod 30 °C.
English: MPA's disposition depends on several transporters.
Croatian: Raspoloživost MPA ovisi o nekoliko prijenosnika.
English: 300 hard capsules
Croatian: 300 tvrdih kapsula
English: Do not throw away any medicines via wastewater or household waste.
Croatian: Ne uklanjajte lijekove putem otpadnih voda ili kućnog otpada.
English: Separate guides for healthcare professionals and patients should be provided.
Croatian: Treba izraditi zasebne vodiče za zdravstvene radnike i bolesnike.
English: Talk to your doctor if you develop a persistent cough or breathlessness
Croatian: Razgovarajte sa svojim liječnikom ako razvijete stalni kašalj ili nedostatak zraka
English: Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
Croatian: Vaš će liječnik razgovarati s Vama o rizicima u slučaju trudnoće i drugim mogućim mjerama koje možete poduzeti da biste spriječili odbacivanje presađenog organa:
English: • The dose given will vary depending on the size of the child.
Croatian: • Propisana doza će se razlikovati ovisno o veličini djeteta.
English: If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate.
Croatian: Ako ne razumijete te upute u potpunosti, zamolite liječnika da Vam ih još jednom objasni prije nego što uzmete mikofenolat.
English: Paediatric population < 2 years
Croatian: Pedijatrijska populacija u dobi od < 2 godine
English: • rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis)
Croatian: • rifampicin (antibiotik koji se koristi za prevenciju i liječenje infekcija kao što je tuberkuloza
English: These changes are not associated with impaired neutrophil function.
Croatian: Te promjene nisu povezane s oštećenjem funkcije neutrofila.
English: • Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
Croatian: • Vaši jajnici više ne rade (prerani prestanak rada jajnika, što je potvrdio specijalist ginekolog)
English: Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojavamožda trebate hitno medicinsko liječenje:
English: The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Croatian: Čini se da je rizik vezan uz intenzitet i trajanje imunosupresije, a ne uz primjenu nekog određenog lijeka.
English: What Myclausen is and what it is used for
Croatian: Što je Myclausen i za što se koristi
English: Two complementary forms of contraception simultaneously are preferred.
Croatian: Prednost se daje istodobnoj uporabi dvaju komplementarnih oblika kontracepcije.
English: Other medicines and Myclausen
Croatian: Drugi lijekovi i Myclausen
English: Calculations based on animal data show that the maximum amount of MPA that could potentially be transferred to woman is so low that it would be unlikely to have an effect.
Croatian: Izračuni temeljeni na podacima prikupljenima u životinja pokazuju da je maksimalna količina MPA koja bi se potencijalno mogla prenijeti na ženu toliko mala da njezin učinak nije vjerojatan.
English: As a result, your body will not be as good as normal at fighting infections.
Croatian: Rezultat toga je da Vaše tijelo neće biti kao inače otporno na infekcije.
English: • cholestyramine (used to treat high cholesterol)
Croatian: • kolestiramin (koristi se za liječenje visokog kolesterola)
English: Your doctor may request more than one test to ensure you are not pregnant before starting treatment.
Croatian: Vaš liječnik može zatražiti da napravite više od jednoga testa prije liječenja, kako bi bio siguran da niste trudni.
English: It will be explained that the correct course of action, based on an assessment of the individual benefit-risk, will be determined on a case by case basis through a discussion between the treating physician and the patient.
Croatian: Objasnit će se da će se pravilan plan djelovanja, utemeljen na ocjeni individualnog omjera koristi i rizika, utvrditi za svaki slučaj pojedinačno kroz razgovor između nadležnog liječnika i bolesnice.
English: In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30 % should be expected.
Croatian: Nasuprot tome, ako se prekine istodobno liječenje ciklosporinom, treba očekivati povećanje AUC-a MPA od oko 30 %.
English: Multidrug resistance protein 1 (MDR1) is also able to transport MPA, but its contribution seems to be confined to the absorption process.
Croatian: Protein povezan s rezistencijom na više lijekova 1 (MDR1) također može prenositi MPA, ali čini se da je njegov doprinos ograničen na proces apsorpcije.
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzimati dvostruku dozu da biste nadoknadili propuštenu dozu.
English: • Ciclosporin and corticosteroids.
Croatian: • ciklosporinom i kortikosteroidima.
English: In this leaflet the shorter name Myclausen is used.
Croatian: U ovoj uputi koristi se skraćeno ime Myclausen.
English: The information provided in this section will facilitate a correct understanding of the risk and explain the rationale for the following pregnancy prevention measures.
Croatian: Informacije navedene u ovom dijelu olakšat će točno razumijevanje rizika i objasniti razloge za poduzimanje mjera sprječavanja trudnoće opisanih u nastavku.
English: The following areas should be covered in these guides:
Croatian: U tim vodičima treba obuhvatiti sljedeća područja:
English: PHARMACEUTICAL FORM Capsule, hard.
Croatian: OBLIK Kapsula, tvrda.
English: What Myclausen looks like and contents of the pack
Croatian: Kako Myclausen izgleda i sadržaj pakiranja
English: • You have sex without using an effective method of contraception.
Croatian: • ako stupite u spolni odnos bez učinkovite metode kontracepcije.
English: Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported).
Croatian: Testovi na trudnoću moraju se ponavljati sukladno kliničkoj indikaciji (npr. nakon prijave bilo kakvog odstupanja u kontracepciji).
English: • the amount in your blood of things like sugar, fat or cholesterol.
Croatian: • količini tvari koje se nalaze u Vašoj krvi poput šećera, masnoća ili kolesterola.
English: These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide synthesis in sensitive cells.
Croatian: Ti se učinci mogu povezati farmakodinamičkim načinom djelovanja, odnosno inhibicijom sinteze nukleotida u osjetljivim stanicama.
English: It is not known if MPA is present in semen.
Croatian: Nije poznato je li MPA prisutan u spermi.
English: No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Croatian: Učinci na plodnost ili reprodukcijske parametre nisu bili vidljivi na ženki kao ni na daljnjim naraštajima.
English: Contraception (see section 4.6)
Croatian: Kontracepcija (vidjeti dio 4.6)
English: If you stop your treatment you may increase the chance of rejection of your transplanted organ.
Croatian: Ako prekinete liječenje, možete povećati mogućnost odbacivanja presađenog organa.
English: Live vaccines should not be given to patients with an impaired immune response.
Croatian: Živa cjepiva ne bi se smjela davati bolesnicima s oslabljenim imunološkim odgovorom.
English: For contraception advice for men see section 4.6.
Croatian: Za savjete o kontracepciji za muškarce vidjeti dio 4.6.
English: Myclausen with food and drink Taking food and drink has no effect on your treatment with Myclausen.
Croatian: Myclausen s hranom i pićem Uzimanje hrane i pića ne utječe na Vaše liječenje lijekom Myclausen.
English: However, keep taking Myclausen until you see him or her.
Croatian: Međutim, nastavite uzimati Myclausen sve dok ga ne posjetite.
English: As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Croatian: Budući da se neke nuspojave javljaju češće u ovoj dobnoj skupini (vidjeti dio 4.8) nego u odraslih, možda će biti potrebno privremeno smanjiti dozu ili prekinuti liječenje, za što treba uzeti u obzir relevantne kliničke faktore, uključujući jačinu reakcije.
English: Other in vitro tests for detection of gene mutation did not demonstrate genotoxic activity.
Croatian: Ostali testovi in vitro za otkrivanje mutacije gena nisu pokazali genotoksičnu aktivnost.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: DODATAK II A. PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: It is recommended, however, to administer Myclausen at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Croatian: Preporučuje se, međutim, primjena Myclausena barem jedan sat prije odnosno tri sata nakon uzimanja sevelamera da bi se umanjio utjecaj na apsorpciju MPA.
English: The proportion of patients with CMV viraemia/syndrome was 13.5 %.
Croatian: Udio bolesnika oboljelih od CMV viremije/sindroma iznosio je 13,5 %.
English: Patients taking Myclausen should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year.
Croatian: Kod bolesnika koji uzimaju Myclausen trebalo bi raditi kompletnu krvnu sliku jedanput tjedno tijekom prvog mjeseca, dva puta mjesečno tijekom drugog i trećeg mjeseca liječenja, a zatim jedanput mjesečno tijekom prve godine.
English: Titanium dioxide (E 171)
Croatian: Titanijev dioksid (E 171)
English: As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6-12 hours post-dose.
Croatian: Kao rezultat enterohepatične recirkulacije sekundarni porasti koncentracije MPA u plazmi obično su primijećeni u razdoblju od otprilike 6-12 sati nakon primjene doze.
English: Non-melanoma skin carcinomas occurred in 3.6 % of patients; other types of malignancy occurred in 1.1 % of patients.
Croatian: Nemelanomski karcinomi kože pojavili su se kod 3,6 % bolesnika, a druge vrste zloćudnih bolesti pojavile su se kod 1,1 % bolesnika.
English: Also other medicines can affect the way Myclausen works.
Croatian: Također, drugi lijekovi mogu utjecati na način djelovanja lijeka Myclausen.
English: This is because Myclausen can affect the way some other medicines work.
Croatian: To je zato što Myclausen može utjecati na način djelovanja drugih lijekova.
English: • feeling anxious or depressed, changes in your mood or thoughts.
Croatian: • osjećaj tjeskobe ili depresije, promjene u raspoloženju ili razmišljanju.
English: These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Croatian: Ti podaci nisu dovoljni da bi se dale preporuke o doziranju, pa se primjena u ovoj dobnoj skupini ne preporučuje.
English: As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Croatian: Da bi se umanjio rizik od nastajanja karcinoma kože, treba ograničiti izlaganje sunčevoj svjetlosti i UV zrakama nošenjem zaštitne odjeće i upotrebom kreme za zaštitu od sunca s visokim zaštitnim faktorom.
English: In order to assist patients in avoiding foetal exposure to mycophenolate and to provide additional important safety information, the Marketing Authorisation holder will provide educational materials to healthcare professionals.
Croatian: Kako bi se bolesnicima pomoglo izbjeći izlaganje ploda mikofenolatu i kako bi im se pružile dodatne važne sigurnosne informacije, nositelj odobrenja će zdravstvenim radnicima dostaviti edukacijske materijale.
English: Most (about 87 %) of the administered dose is excreted in the urine as MPAG.
Croatian: Većina (otprilike 87 %) primijenjene doze izlučuje se u urin u obliku MPAG-a.
English: • If you have ever had a problem with your digestive system such as a stomach ulcer
Croatian: • ako ste ikad imali problem s probavnim sustavom, poput čira na želucu
English: • You plan to become pregnant.
Croatian: • ako planirate zatrudnjeti
English: EU/1/10/647/004 (300 hard capsules)
Croatian: EU/1/10/647/004 (300 tvrdih kapsula)
English: SPECIAL STORAGE CONDITIONS Store below 30 °C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30 °C.
English: • you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).
Croatian: • imate osip, oticanje lica, usana, jezika ili grla, s poteškoćama u disanju - možda imate ozbiljnu alergijsku reakciju na lijek (poput anafilaksije, angioedema).
English: What Myclausen contains
Croatian: Što Myclausen sadrži
English: MPA is a powerful teratogen.
Croatian: MPA ima snažan teratogeni učinak.
English: If you are not sure, talk to your doctor or pharmacist before taking Myclausen.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka Myclausen.
English: Norfloxacin and metronidazole
Croatian: Norfloksacin i metronidazol
English: If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.
Croatian: Ako ste žena koja bi mogla zatrudnjeti, prije početka liječenja morate predočiti negativan nalaz testa na trudnoću i morate se pridržavati savjeta o kontracepciji koje Vam je dao Vaš liječnik.
English: Contraception in women taking Myclausen If you are a woman who could become pregnant you must use an effective methods of contraception with Myclausen.
Croatian: Kontracepcija u žena koje uzimaju Myclausen Ako ste žena koja bi mogla zatrudnjeti, uz Myclausen morate koristiti učinkovitu metodu kontracepcije.
English: MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Croatian: MPA je jak, selektivan, nekompetitivni i reverzibilan inhibitor inozin monofosfat dehidrogenaze te stoga inhibira put de novo sinteze gvanozin nukleotida bez ugradnje u DNK.
English: Guides should also mention that patients should not to give this drug to any other person.
Croatian: U vodičima treba napomenuti i da bolesnici ne smiju davati svoj lijek drugim osobama.
English: Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy.
Croatian: Prednost se daje uporabi dvaju oblika kontracepcije jer time se smanjuje rizik od neplanirane trudnoće.
English: For patients, the text should be appropriately separated for men and women.
Croatian: U tekstu za bolesnike treba prikladno razdvojiti dijelove namijenjene muškarcima odnosno ženama.
English: The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung.
Croatian: Rizik od nastanka bronhiektazija može biti povezan s hipogamaglobulinemijom ili s izravnim učinkom na pluća.
English: Physicians should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy.
Croatian: Liječnici se moraju pobrinuti da žene koje uzimaju mikofenolat razumiju rizik od štetnih učinaka na dijete, potrebu za učinkovitom kontracepcijom i potrebu da se odmah posavjetuju sa svojim liječnikom ako postoji mogućnost trudnoće.
English: What you need to know before you take Myclausen
Croatian: Što morate znati prije nego počnete uzimati Myclausen
English: Patients taking oral contraceptives
Croatian: Bolesnice koje uzimaju oralne kontraceptive
English: Use in special populations
Croatian: Primjena u posebnim populacijama
English: Contraceptive requirements for sexually active male patients (including vasectomised men) and female patients of childbearing potential will be explained.
Croatian: Objasnit će se potreba za kontracepcijom kod spolno aktivnih muškaraca (uključujući vazektomirane muškarce) i žena reproduktivne dobi.
English: There have also been reports of bronchiectasis in children and adults (frequency not known).
Croatian: Također su zabilježeni slučajevi bronhiektazija kod djece i odraslih (učestalost nepoznata).
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Croatian: Ove infekcije su često povezane sa suprimiranom ukupnom funkcijom imunološkog sustava i mogu dovesti do ozbiljnih ili smrtonosnih stanja koje liječnik treba uzeti u obzir u diferencijalnoj dijagnostici imunosuprimiranih bolesnika koji imaju sve slabiju bubrežnu funkciju ili neurološke simptome.
English: The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely.
Croatian: Farmakodinamički profil i prijavljene nuspojave upućuju na to da učink nije vjerojatan.
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Croatian: Stoga treba izbjegavati njegovu primjenu kod bolesnika s rijetkim nasljednim nedostatkom hipoksantin gvanin fosforibozil transferaze (HGPRT) poput Lesch-Nyhanova i Kelley-Seegmillerova sindroma.
English: Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Croatian: Telmisartan mijenja eliminaciju MPA tako što pospješuje ekspresiju PPAR gama (receptor za aktivator proliferacije peroksisoma-gama), što pak dovodi do pojačane ekspresije i aktivnosti UGT1A9.
English: Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG.
Croatian: Ne treba očekivati da će se hemodijalizom ukloniti klinički značajne količine MPA ili MPAG-a.
English: In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
Croatian: U onim slučajevima predoziranja u kojima su zabilježene, nuspojave se ubrajaju u okvire poznatog profila sigurnosti primjene lijeka.
English: The need for subsequent pregnancy tests during treatment will also be explained.
Croatian: Objasnit će se i potreba za provođenjem dodatnih testova na trudnoću tijekom liječenja.
English: Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.
Croatian: Liječenje će se nastaviti toliko dugo koliko je potrebno za prevenciju odbacivanja Vašeg transplantiranog organa.
English: • pneumonia, bronchitis
Croatian: • upala pluća, bronhitis
English: If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Croatian: Ako dođe do kontakta, treba temeljito oprati zahvaćeno područje vodom i sapunom, a oči isprati običnom vodom.
English: • azathioprine or other medicines which suppress your immune system (given after a transplant operation)
Croatian: • azatioprin ili druge lijekove koji potiskuju Vaš imunološki sustav (daju se bolesnicima nakon operacije presađivanja)
English: Patients will be informed that they should not stop taking mycophenolate mofetil but must contact their doctor immediately.
Croatian: Bolesnice treba uputiti da ne prestanu uzimati mofetilmikofenolat, ali da se odmah moraju javiti svom liječniku.
English: However, hepatic disease with predominantly biliary damage, such as primary biliary cirrhosis, may show a different effect.
Croatian: No jetrene bolesti s oštećenjima koja pretežito zahvaćaju bilijarno stablo, poput primarne bilijarne ciroze, mogu pokazati drugačiji učinak.
English: Hepatic transplant patients were followed for at least 1 year, but less than 3 years.
Croatian: Bolesnici s presađenom jetrom praćeni su u razdoblju od najmanje 1 do najdulje 3 godine.
English: What Myclausen is and what it is used for What you need to know before you take Myclausen How to take Myclausen
Croatian: Što je Myclausen i za što se koristi Što morate znati prije nego počnete uzimati Myclausen Kako uzimati Myclausen
English: Oblong, white capsules.
Croatian: Duguljaste, bijele kapsule.