FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional amendments have been made regarding use of contraception in women and pregnancy testing, to clarify the requirements.
Croatian: Unesene su i dodatne izmjene u informacije o primjeni kontracepcije u žena i testiranju na trudnoću, kako bi se pojasnilo što treba činiti.
English: Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Croatian: Teške, po život opasne infekcije, uključujući meningitis, endokarditis, tuberkulozu i atipičnu mikobakterijsku infekciju.
English: If you take more Myclausen than you should
Croatian: Ako uzmete više lijeka Myclausen nego što ste trebali
English: MPA at clinically relevant concentrations is 97 % bound to plasma albumin.
Croatian: 97 % MPA je pri klinički značajnim koncentracijama vezano na albumin u plazmi.
English: There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8).
Croatian: Također postoje izolirani izvještaji o intersticijskoj bolesti pluća i plućnoj fibrozi, od kojih su neke bile sa smrtnim ishodom (vidjeti dio 4.8).
English: • gut problems including bleeding, liver problems
Croatian: • problemi s crijevima uključujući krvarenje, problemi s jetrom
English: Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: 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), not known (cannot be estimated from the available data).
Croatian: Unutar pojedine klasifikacije organskih sustava nuspojave su razvrstane prema sljedećim kategorijama 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), nije poznato (ne može se procijeniti prema dostupnim podacima).
English: The health professional educational material should contain: · The Summary of Product Characteristics · Guide for healthcare professionals
Croatian: Edukacijski materijali za zdravstvene radnike moraju sadržavati: · Sažetak opisa svojstava lijeka · Vodič za zdravstvene radnike
English: Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
Croatian: Podaci o sigurnosti prikupljani tijekom tri godine među bolesnicima s presađenim bubregom i srcem nisu pokazali neočekivane promjene u učestalosti pojave zloćudnih bolesti u odnosu na jednogodišnje podatke.
English: PHARMACEUTICAL FORM AND CONTENTS 100 hard capsules
Croatian: OBLIK I SADRŽAJ 100 tvrdih kapsula
English: Antacids and proton pump inhibitors (PPIs)
Croatian: Antacidi i inhibitori protonske pumpe (IPP)
English: If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately.
Croatian: Ako ipak zatrudnite tijekom liječenja mikofenolatom, morate o tome odmah obavijestiti svog liječnika.
English: The MAH shall ensure that in each MS where Myclausen is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Myclausen are provided with the following educational package: · Physician educational material
Croatian: Nositelj odobrenja pobrinut će se da u svim državama članicama u kojima se Myclausen nalazi na tržištu, svi zdravstveni radnici i bolesnici za koje se očekuje da će propisivati, izdavati ili primjenjivati Myclausen dobiju sljedeći paket edukacijskih materijala: · Edukacijske materijale za liječnike · Paket s informacijama za bolesnike
English: This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
Croatian: To uključuje infekcije mozga, kože, usta, želuca i crijeva, pluća i mokraćnog sustava.
English: A negligible amount of substance is excreted as MPA (< 1 % of dose) in the urine.
Croatian: Zanemariva količina lijeka izlučuje se u urin u obliku MPA (< 1 % doze).
English: • You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Croatian: • ako Vam izostane mjesečnica ili mislite da Vam je izostala mjesečnica, ako imate neuobičajeno menstrualno krvarenje ili ako mislite da biste mogli biti trudni
English: • If this happens, wash the area thoroughly with soap and water.
Croatian: • Ako se to dogodi, kožu na koju je dospio prašak temeljito operite sapunom i vodom.
English: • shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
Croatian: • nedostatak zraka, kašalj, koji može biti zbog bronhiektazije (stanja u kojemu su dišni putovi u plućima nenormalno prošireni) ili plućne fibroze (stvaranja ožiljaka na plućima).
English: Prescribers should refer to national guidelines for influenza vaccination.
Croatian: Liječnici koji ga propisuju trebaju se pridržavati državnih smjernica za cijepljenje protiv gripe.
English: • If you have any unexpected bruising or bleeding
Croatian: • ako imate bilo kakve neočekivane modrice ili krvarenje
English: Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the highest dose (systemic exposure levels equivalent to or greater than clinical exposure).
Croatian: Gastrointestinalni i bubrežni učinci u skladu s dehidracijom također su primijećeni kod majmuna pri najvećoj dozi (razine sistemske izloženosti ekvivalentne ili veće od kliničke izloženosti).
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingooophorectomy)
Croatian: • Vaši jajovodi i oba jajnika su odstranjeni operacijom (obostrana salpingo-ooforektomija)
English: It is recommended that patients who develop persistent pulmonary symptoms, such as cough and dyspnoea, are investigated.
Croatian: Preporučuje se preispitati bolesnike koji razviju perzistentne plućne simptome, kao što su kašalj i dispneja.
English: In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12 h) of 18 % to 70 %.
Croatian: Kod bolesnika koji ne uzimaju i ciklosporin, istodobna primjena mofetilmikofenolata i rifampicina rezultirala je smanjenjem izloženosti MPA-u (AUC0-12 h) od 18 % do 70 %.
English: Myclausen is used to prevent your body rejecting a transplanted organ.
Croatian: Myclausen se koristi kako bi se spriječilo da tijelo odbaci presađeni organ:
English: However, the following treatment-related adverse events were more frequent in the paediatric population, particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Croatian: Međutim, sljedeće nuspojave liječenja bile su učestalije u pedijatrijskoj populaciji nego kod odraslih, a osobito kod djece mlađe od 6 godina: proljev, sepsa, leukopenija, anemija i infekcija.
English: Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Croatian: Kapsule nemojte otvarati ili lomiti i nemojte udisati prašak koji se nalazi unutar kapsule te izbjegavajte doticaj praška s kožom.
English: AcMPAG is pharmacologically active and is suspected to be responsible for some of mycophenolate mofetil´s side effects (diarrhoea, leucopenia).
Croatian: AcMPAG je farmakološki aktivan i smatra se da bi mogao biti odgovoran za neke od nuspojava mofetilmikofenolata (proljev, leukopenija).
English: If you take more Myclausen than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više lijeka Myclausen nego što ste trebali, razgovarajte s liječnikom ili odmah otiđite u bolnicu.
English: • Your womb (uterus) has been removed by surgery (hysterectomy)
Croatian: • Vaša maternica (uterus) je odstranjena operacijom (histerektomija)
English: Treatment with Myclausen should be initiated and maintained by appropriately qualified transplant specialists.
Croatian: Liječenje Myclausenom trebaju započeti i voditi liječnici specijalisti odgovarajuće kvalificirani u području transplantacijske medicine.
English: Do not break or crush the tablets.
Croatian: Tablete nemojte lomiti ili drobiti.
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8 %) were minimal and are not considered clinically significant.
Croatian: Promjene u farmakokinetici mikofenolglukuronida (MPAG-a) (fenolni glukuronid MPA) bile su minimalne (MPAG se povećao za 8 %) i nisu se smatrale klinički značajnima.
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Croatian: Preosjetljivost Prijavljene su reakcije preosjetljivosti, uključujući angioneurotski edem i anafilaktičku reakciju.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30 % following a single dose of mycophenolate mofetil.
Croatian: Međutim, kombinacija norfloksacina i metronidazola smanjila je izloženost MPA-u za približno 30 % nakon jedne doze mofetilmikofenolata.
English: It will explain that although this guide is very important it does not provide full information on mycophenolate mofetil and that the SmPC (healthcare professionals) and package leaflet (patients) supplied with the medicine must also be read carefully.
Croatian: Objasnit će se i da taj vodič, iako je vrlo važan, ne sadrži sve informacije o mofetilmikofenolatu i da se stoga mora pažljivo pročitati i Sažetak opisa svojstava lijeka (zdravstveni radnici) odnosno Uputa o lijeku (bolesnici) koja je priložena u pakiranju lijeka.
English: It is recommended that the second test should be performed 8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two test 8 - 10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8 - 10 days later.
Croatian: Ako kod presađivanja organa preminulih davatelja nije moguće provesti dva testa u razmaku od 8 - 10 dana prije početka liječenja (zbog razdoblja dostupnosti presatka), jedan test na trudnoću mora se provesti neposredno prije početka liječenja, a drugi 8 - 10 dana nakon toga.
English: The recommended dose is 600 mg per taken twice a day.
Croatian: Preporučena doza je 600 mg/m i uzima se dvaput dnevno.
English: Do not take Myclausen
Croatian: Nemojte uzimati Myclausen
English: No substantial alteration of MPA pharmacokinetics is anticipated and Myclausen dose adjustment is not required.
Croatian: Ne očekuje se znatna promjena farmakokinetike MPA pa nije potrebna prilagodba doze Myclausena.
English: • A kidney, heart or liver.
Croatian: • Bubreg, srce ili jetru.
English: It is recommended to monitor MPA exposure levels and to adjust Myclausen doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Croatian: Preporučuje se praćenje razina izloženosti MPA-u i prilagođavanje doze Myclausena prema njima radi zadržavanja kliničke djelotvornosti pri istodobnoj primjeni rifampicina.
English: The usual doses are shown below.
Croatian: Uobičajene doze navedene su u tekstu koji slijedi.
English: Dose adjustment of Myclausen does not appear to be necessary.
Croatian: Čini se da prilagodba doze Myclausena nije potrebna.
English: In the kidney MPA and its metabolites potently interact with renal organic anion transporters.
Croatian: U bubrezima MPA i njegovi metaboliti ulaze u snažne interakcije s bubrežnim organskim anionskim prijenosnicima.
English: It will provide details about the nature and magnitude of the risk, in line with the information provided in the SmPC.
Croatian: Sadržavat će pojedinosti o prirodi i opsegu rizika, u skladu s informacijama navedenima u Sažetku opisa svojstava lijeka.
English: • antacids or proton pump inhibitors (used for acid problems in your stomach such as indigestion)
Croatian: • antacide ili inhibitore protonske pumpe (koriste se za poteškoće sa želučanom kiselinom poput loše probave)
English: Mycophenolate has been shown to be genotoxic in animal studies at concentrations exceeding the human therapeutic exposures by small margins, such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Croatian: U ispitivanjima na životinjama mikofenoklat se pokazao genotoksičnim pri koncentracijama koje tek neznatno premašuju terapijske razine izloženosti u ljudi, zbog čega se rizik od genotoksičnog učinka na stanice sperme ne može potpuno isključiti.
English: The antibody response to other vaccines may be diminished (see also section 4.4).
Croatian: Odgovor antitijela na druga cjepiva mogao bi biti slabiji (vidjeti i dio 4.4).
English: In healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately.
Croatian: Kod zdravih dobrovoljaca nisu primijećene značajne interakcije pri istodobnoj primjeni mofetilmikofenolata i norfloksacina ili metronidazola.
English: The PRAC therefore recommended to amend the product information, to update information on teratogenic effects and pregnancy as well as the contraception recommendations for male patients.
Croatian: PRAC je stoga preporučio izmjenu informacija o lijeku radi ažuriranja informacija o teratogenim učincima i trudnoći te preporuka za kontracepciju u bolesnika muškog spola.
English: Talk to your doctor straight away before taking Myclausen:
Croatian: Odmah se obratite se svom liječniku prije uzimanja lijeka Myclausen:
English: ) were 28-75 % higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Croatian: 28-75 % više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima bubrežnog oštećenja.
English: Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
Croatian: Takve infekcije uključuju latentnu virusnu reaktivaciju, kao što su reaktivacije hepatitisa B ili hepatitisa C te infekcije uzrokovane poliomavirusima ( nefropatija povezana s BK virusom, progresivna multifokalna leukoencefalopatija PML povezana s JC virusom).
English: Therefore, the following precautionary measures are recommended: sexually active male patients or their female partners are recommended to use reliable contraception during treatment of the male patient and for at least 90 days after cessation of mycophenolate mofetil.
Croatian: Stoga se preporučuju sljedeće mjere opreza: preporučuje se da spolno aktivni bolesnici muškog spola ili njihove partnerice koriste pouzdanu kontracepciju tijekom liječenja muškarca i najmanje 90 dana nakon prestanka primjene mofetilmikofenolata.
English: In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T and B lymphocytes.
Croatian: U slučajevima održane, klinički relevantne hipogamaglobulinemije, moraju se razmotriti odgovarajuće kliničke radnje uzimajući u obzir potentne citostatičke učinke koje mikofenolatna kiselina ima na T- i B-limfocite.
English: Other problems such as: • weight loss, gout, high blood sugar, bleeding, bruising.
Croatian: Ostale poteškoće poput: • gubitka težine, gihta, visokog šećera u krvi, krvarenja, modrica.
English: Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code: L04AA06
Croatian: Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA06
English: Each carton contains either 100 or 300 capsules.
Croatian: Jedna kutija sadrži 100 ili 300 kapsula.
English: If neutropenia develops, dosing with Myclausen should be interrupted or the dose reduced (see section 4.4).
Croatian: Ako se pojavi neutropenija, treba prekinuti primjenu Myclausena ili smanjiti dozu (vidjeti dio 4.4).
English: Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting.
Croatian: Neke od uobičajenijih poteškoća su proljev, manji broj leukocita ili eritrocita u Vašoj krvi, infekcija i povraćanje.
English: • An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil.
Croatian: Uvod svakog vodiča čitatelju će pojasniti da je svrha vodiča upozoriti ga da mora izbjegavati izlaganje fetusa lijeku i objasniti mu kako minimizirati rizik od prirođenih mana i spontanog pobačaja koji je povezan s primjenom mofetilmikofenolata.
English: Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations.
Croatian: Dva ispitivanja genotoksičnosti (in vitro analiza mišjeg limfoma i in vivo mikronukleus test mišje koštane srži) pokazala su potencijal mofetilmikofenolata da uzrokuje kromosomske aberacije.
English: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na mofetilmikofenolat, mikofenolatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2).
Croatian: Nisu potrebne prilagodbe doze kod bolesnika kod kojih nakon presađivanja dolazi do odgođene funkcije presađenog bubrega (vidjeti dio 5.2).
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Croatian: Gastrointestinalni učinci primijećeni su kod pasa na razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenim dozama.
English: Heart and blood vessel problems such as: • change in blood pressure, unusual heartbeat, widening of blood vessels.
Croatian: Poteškoće sa srcem i krvnim žilama kao što su: • promjena krvnog tlaka, poremećeni puls, proširenje krvnih žila.
English: In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms.
Croatian: U nekima od tih slučajevima zamjena lijeka Mofetilmikofenolata drugim imunosupresivom rezultirala je poboljšanjem respiratornih simptoma.
English: Prior to the use of Myclausen in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a follow-up pregnancy questionnaire, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Nositelj odobrenja mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i format edukacijskog programa i upitnika za praćenje trudnoće, uključujući medije komunikacije, modalitete distribucije i sve druge aspekte programa.
English: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Croatian: Svi bolesnici s presatkom izloženi su povećanom riziku od oportunističkih infekcija; rizik se povećava s ukupnom količinom imunosupresiva (vidjeti dio 4.4).
English: • The first dose of oral Myclausen will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications.
Croatian: • Prvu dozu lijeka Myclausen za primjenu kroz usta primit ćete najmanje 4 dana nakon presađivanja, kad budete mogli gutati lijekove koji se primjenjuju kroz usta.
English: Patients should be instructed to consult their physician immediately should pregnancy occur.
Croatian: Bolesnice treba upozoriti da se odmah obrate liječniku ako dođe do trudnoće.
English: Two complementary forms of contraception simultaneously are preferred to minimise the potential for contraceptive failure and unintended pregnancy.
Croatian: Prednost se daje istodobnoj uporabi dvaju komplementarnih oblika kontracepcije kako bi se minimizirala mogućnost neučinkovitosti kontraceptiva i neplanirane trudnoće.
English: Driving and using machines Myclausen is not likely to affect you being able to drive or use any tools or machines.
Croatian: Upravljanje vozilima i strojevima: Nije vjerojatno da Myclausen utječe na Vašu sposobnost upravljanja motornim vozilima ili korištenja ikakvih alata ili strojeva.
English: The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with mycophenolate mofetil, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Myclausen.
Croatian: Cilj edukacijskog programa je osigurati da se zdravstveni radnici i bolesnici upoznaju s teratogenošću i mutagenošću lijeka, potrebom za provođenjem testova na trudnoću prije početka liječenja lijekom Myclausen, potrebom za kontracepcijom i kod muškaraca i kod žena te mjerama koje treba poduzeti u slučaju trudnoće tijekom liječenja lijekom Myclausen.
English: In experimental models, mycophenolate mofetil was not tumourigenic.
Croatian: U eksperimentalnim modelima mofetilmikofenolat nije bio tumorogen.
English: In patients with renal impairment in whom Myclausen and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for ganciclovir should be observed and patients should be monitored carefully.
Croatian: Kod bolesnika s oštećenjem bubrega kod kojih se istodobno primjenjuju Myclausen i ganciklovir ili njegovi predlijekovi, npr. valganciklovir, treba razmotriti primjenu preporučene doze ganciklovira i pažljivo nadzirati bolesnika.
English: Because of robust clinical evidence showing a high risk of abortion and congenital malformations when mycophenolate mofetil is used in pregnancy every effort to avoid pregnancy during treatment should be taken.
Croatian: Zbog robusnih kliničkih dokaza koji ukazuju na visok rizik od pobačaja i kongenitalnih malformacija kada se mofetilmikofenolat primjenjuje tijekom trudnoće, potrebno je poduzeti sve mjere kako bi se izbjegla trudnoća tijekom liječenja.
English: Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose with 93 % of the administered dose recovered in the urine and 6 % recovered in the faeces.
Croatian: Peroralna primjena radioizotopom označenog mofetilmikofenolata rezultira potpunom ponovnom detekcijom primijenjene doze, od čega se 93 % primijenjene doze ponovno detektira u urinu, a 6 % u fecesu.
English: Take care not to let any powder from inside a broken capsule get onto your skin.
Croatian: Pazite da prašak iz oštećene kapsule ne dođe u dodir s Vašom kožom.
English: Oral Myclausen should be initiated within 72 hours following transplantation.
Croatian: Peroralni Myclausen treba uzeti u roku od 72 sata nakon presađivanja.
English: The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Croatian: Čini se da je neklinički profil toksičnosti mofetilmikofenolata u skladu s nuspojavama primijećenim tijekom kliničkih ispitivanja kod ljudi, koje bolesnicima pružaju značajnije podatke o sigurnosti primjene (vidjeti dio 4.8).
English: Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (2327%) in the unborn baby.
Croatian: Mikofenolat vrlo često uzrokuje spontani pobačaj (50%) i teške prirođene mane (23 - 27%) kod nerođena djeteta.