FrancophonIA/ELRC3.0 huggingface dataset:
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 s visokim ukupnim imunosupresivnim opterećenjem i mogu dovesti do ozbiljnih ili smrtonosnih stanja koje liječnik mora uzeti u obzir u diferencijalnoj dijagnostici imunosuprimiranih bolesnika koji imaju sve slabiju bubrežnu funkciju ili neurološke simptome.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention: very common
Croatian: Odgovarajuća kategorija učestalosti za svaku nuspojavu definirana je na sljedeći način: vrlo često
English: Also try not to get it on your skin, inside your mouth or nose.
Croatian: Također pripazite da Vam prašak ne dospije na kožu, u usta ili nos.
English: CellCept contains aspartame.
Croatian: • CellCept sadrži aspartam.
English: Always take CellCept exactly as your doctor has told you.
Croatian: Uvijek uzimajte CellCept točno onako kako Vam je rekao liječnik.
English: They will follow the instructions under Section 7 “Making up the medicine”.
Croatian: Prilikom pripreme slijedit će upute u dijelu 7 „Priprema lijeka“.
English: This needs mixing with glucose before using.
Croatian: Prije uporabe potrebno ga je pomiješati s glukozom.
English: • antibiotics - used to treat bacterial infections
Croatian: • antibiotike - koriste se za liječenje bakterijskih infekcija
English: In contrast, if concomitant CsA 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: Live vaccines should not be given to patients with an impaired immune response.
Croatian: Živa cjepiva ne smiju se davati bolesnicima s oslabljenim imunološkim odgovorom.
English: The MAH shall ensure that in each MS where Cellcept is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Cellcept are provided with the following educational package: · Physician educational material · Patient information pack
Croatian: Nositelj odobrenja pobrinut će se da u svim državama članicama u kojima se CellCept nalazi na tržištu, svi zdravstveni radnici i bolesnici za koje se očekuje da će propisivati, izdavati ili primjenjivati CellCept dobiju sljedeći paket edukacijskih materijala: · Edukacijske materijale za liječnike · Paket s informacijama za bolesnike
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: Paediatric population aged 2 to 18 years
Croatian: Pedijatrijska populacija u dobi od 2 do 18 godina
English: They have “CellCept 500” engraved on one side and “ROCHE” on the other.
Croatian: Imaju utisnuto "CellCept 500" s jedne strane i „ROCHE“ s druge strane
English: What CellCept contains
Croatian: Što CellCept sadrži
English: 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: Put the end of the dispenser directly into your mouth and swallow the medicine.
Croatian: • Vrh dozatora stavite izravno u usta i progutajte lijek.
English: (150 (3x50) tablets multipack)
Croatian: (150 (3x50) tableta u višestrukom pakiranju)
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: Do not have this medicine if any of the above applies to you.
Croatian: Nemojte primati ovaj lijek ako se bilo što od gore navedenog odnosi na Vas.
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
Croatian: • Vaši jajovodi i oba jajnika su odstranjeni operacijom (obostrana salpingo-ooforektomija)
English: However, hepatic disease with predominantly biliary damage, such as primary biliary cirrhosis, may show a different effect.
Croatian: No bolesti jetre pretežito s oštećenjem žuči, poput primarne bilijarne ciroze, mogu pokazati drugačiji učinak.
English: The medicine comes as a powder.
Croatian: Lijek je u obliku praška.
English: Film coated tablets (tablets).
Croatian: Filmom obložene tablete (tablete).
English: Contents of the pack and other information What CellCept contains
Croatian: Sadržaj pakiranja i druge informacije Što CellCept sadrži
English: CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor.
Croatian: CellCept je inhibitor IMPDH (inozin monofosfat dehidrogenaze).
English: Powder for concentrate for solution for infusion: 3 years.
Croatian: Prašak za koncentrat za otopinu za infuziju: 3 godine.
English: * contains phenylalanine equivalent to 2.78 mg/5 mL of suspension.
Croatian: *sadrži fenilalanin u vrijednosti 2,78 mg/5 ml suspenzije.
English: even if their symptoms are the same as yours
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A, antibiotics)
Croatian: Lijekovi koji se uključuju u enterohepatičnu recirkulaciju (npr. kolestiramin, ciklosporin A, antibiotici)
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: Swallow your tablets whole with a glass of water.
Croatian: Kapsule progutajte cijele s čašom vode
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of CellCept.
Croatian: Međutim, kombinacija norfloksacina i metronidazola smanjila je izloženost MPA-u za približno 30% nakon jedne doze lijeka CellCept.
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 dozi, pa se primjena u ovoj dobnoj skupini ne preporučuje.
English: What CellCept looks like and contents of the pack
Croatian: Kako CellCept izgleda i sadržaj pakiranja
English: the number of your blood cells or signs of infections
Croatian: broju Vaših krvnih stanica ili znakovima infekcija
English: The most serious gastrointestinal disorders were ulceration and hemorrhage which are known risks associated with mycophenolate mofetil.
Croatian: Najozbiljniji poremećaji probavnog sustava bili su ulceracija i krvarenje, koji su poznati rizici povezani s mofetilmikofenolatom.
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, sljedeći štetni događaji povezani s liječenjem bili su učestaliji u pedijatrijskoj populaciji nego kod odraslih, a osobito kod djece mlađe od 6 godina: proljev, sepsa, leukopenija, anemija i infekcija.
English: Caution is therefore recommended when administering these drugs concomitantly with CellCept.
Croatian: Stoga se preporučuje oprez kada se ti lijekovi primjenjuju istodobno s lijekom CellCept.
English: The patient information pack should contain: · The Package Leaflet · Guide for patients
Croatian: Paket s informacijama za bolesnike mora sadržavati: · Uputu o lijeku · Vodič za bolesnike
English: Note: If required, CellCept 1 g/5 ml powder for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Croatian: Napomena: Po potrebi, prašak za oralnu suspenziju CellCept 1 g/5 ml može se davati i putem nazogastrične sonde veličine najmanje 8 French (s unutarnjim promjerom najmanje 1,7 mm).
English: Cellcept is usually given by a doctor or nurse in hospital.
Croatian: Uobičajeno je da liječnik ili medicinska sestra primjenjuju CellCept u bolnici.
English: Other medicines and CellCept
Croatian: Drugi lijekovi i CellCept
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 nuspojava - možda trebate hitno medicinsko liječenje:
English: (100 capsules)
Croatian: (100 kapsula)
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 karcinoma kože, potrebno je ograničiti izlaganje sunčevoj svjetlosti i UV zrakama nošenjem zaštitne odjeće i upotrebom kreme za zaštitu od sunca s visokim zaštitnim faktorom.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne možete podnijeti ili probaviti neke šećere, obratite se liječniku prije nego uzmete ovaj lijek.
English: Do not take CellCept:
Croatian: Nemojte uzimati CellCept:
English: • If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Croatian: • ako ne koristite učinkovitu kontracepciju (pogledajte dio 'Trudnoća, kontracepcija i dojenje')
English: Prescribers should refer to national guidelines for influenza vaccination.
Croatian: Liječnici koji ga propisuju moraju se pridržavati državnih smjernica za cijepljenje protiv gripe.
English: Important information about some of the ingredients of CellCept
Croatian: Važne informacije o nekim sastojcima lijeka CellCept
English: Patients in all study arms also received cyclosporine and corticosteroids.
Croatian: U svim su ispitivanim skupinama bolesnici također primali ciklosporin i kortikosteroide.
English: (300 capsules)
Croatian: (300 kapsula)
English: A kidney, heart or liver.
Croatian: • Bubreg, srce ili jetru.
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: PHARMACEUTICAL FORM Powder for oral suspension.
Croatian: OBLIK Prašak za oralnu suspenziju.
English: In some of these cases switching CellCept to another immunosuppressant resulted in improvement in respiratory symptoms.
Croatian: U nekima od tih slučajevima zamjena lijeka CellCept drugim imunosupresivom rezultirala je poboljšanjem respiratornih simptoma.
English: Measure 94 mL of purified water in a graduated cylinder.
Croatian: Odmjerite 94 ml pročišćene vode u graduiranom cilindru.
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 tests 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: CellCept has a moderate influence on your ability to drive or use any tools or machines.
Croatian: CellCept umjereno utječe na Vašu sposobnost upravljanja motornim vozilima ili korištenja ikakvih alata ili strojeva.
English: It is recommended to monitor MPA exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Croatian: Preporučuje se praćenje razina izloženosti MPA-u i prilagođavanje doze lijeka CellCept prema njima radi zadržavanja kliničke djelotvornosti pri istodobnoj primjeni rifampicina.
English: Patients taking CellCept 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 CellCept potrebno je 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: In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Croatian: Kod bolesnika koji ne uzimaju i ciklosporin, istodobna primjena lijeka CellCept i rifampicina rezultirala je smanjenjem izloženosti MPA-u (AUC0-12 h) od 18% do 70%.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: • Immediately after use - take the dispenser to pieces and rinse it under running tap water.
Croatian: • Odmah nakon uporabe - rastavite dozator i isperite ga mlazom vode iz slavine.
English: Shake bottle well before use
Croatian: Prije uporabe bocu dobro protresti
English: Swallow your capsules whole with a glass of water Do not break or crush them
Croatian: • Tablete progutajte cijele s čašom vode • Nemojte ih lomiti ili drobiti
English: • olfactory nerve agenesis.
Croatian: • ageneze olfaktornog živca.
English: In healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin or metronidazole separately.
Croatian: Kod zdravih dobrovoljaca nisu opažene značajne interakcije pri istodobnoj primjeni lijeka CellCept i norfloksacina ili metronidazola.
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 Cellcept, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Cellcept.
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 CellCept, potrebom za kontracepcijom i kod muškaraca i kod žena te mjerama koje treba poduzeti u slučaju trudnoće tijekom liječenja lijekom CellCept.
English: magnesium stearate
Croatian: magnezijev stearat
English: The usable volume of the reconstituted suspension is 160-165 ml.
Croatian: Iskoristiva količina pripremljene suspenzije iznosi 160165 ml.
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: • pneumonia, bronchitis,
Croatian: • upala pluća, bronhitis
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: All patients treated with immunosuppressants are at increased risk of bacterial, viral and fungal infections (some of which may lead to a fatal outcome), including those caused by opportunistic agents and latent viral reactivation.
Croatian: Svi bolesnici liječeni imunosupresivima izloženi su povećanom riziku od bakterijskih, virusnih i gljivičnih infekcija (od kojih neke mogu imati smrtni ishod), uključujući infekcije uzrokovane oportunističkim agensima i reaktivacijom latentnih virusa.
English: If you think that you have had too much medicine, talk to your doctor or nurse straight away.
Croatian: Ako mislite da ste primili previše lijeka, odmah razgovarajte sa svojim liječnikom ili medicinskom sestrom.
English: • CellCept capsules are oblong shaped with one end blue and the other end brown.
Croatian: • CellCept kapsule su duguljaste s jednim plavim i jednim smeđim krajem.
English: Patients receiving CellCept should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow failure.
Croatian: Bolesnike koji primaju CellCept potrebno je uputiti da odmah prijave bilo koji znak infekcije, neočekivanu pojavu modrica, krvarenje ili bilo koju drugu manifestaciju zatajivanja koštane srži.
English: Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept.
Croatian: Žene reproduktivne dobi mora se upoznati s rizicima i upozoriti da se pridržavaju preporuka navedenih u dijelu 4.6 (npr. korištenja kontracepcijskih metoda, provođenja testova na trudnoću) prije, tijekom i nakon liječenja lijekom CellCept.
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: A study of the co-administration of CellCept (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of CellCept on the ovulation suppressing action of the oral contraceptives.
Croatian: Ispitivanje istodobne primjene lijeka CellCept (1 g dvaput dnevno) i kombiniranih oralnih kontraceptiva koji sadrže etinilestradiol (0,02 mg do 0,04 mg) i levonorgestrel (0,05 mg do 0,15 mg), dezogestrel (0,15 mg) ili gestoden (0,05 mg do 0,10 mg) provedeno na 18 ženskih osoba kojima nije presađen organ (nisu uzimale druge imunosupresive) tijekom 3 uzastopna menstrualna ciklusa nije pokazalo klinički značajan utjecaj lijeka CellCept na sprječavanje ovulacije izazvano oralnim kontraceptivima.
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: The parent substance mycophenolate mofetil can be measured systemically during intravenous infusion.
Croatian: Osnovna supstanca mofetilmikofenolat može se sistemski mjeriti tijekom intravenske infuzije.
English: If you take more CellCept than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više lijeka CellCept nego što ste trebali, razgovarajte s liječnikom ili odmah otiđite u bolnicu.
English: The shelf-life of the powder for oral suspension is 2 years.
Croatian: Rok valjanosti praška za oralnu suspenziju je 2 godine.
English: Hypersensitivity reactions to CellCept have been observed (see section 4.8).
Croatian: Primijećene su reakcije preosjetljivosti na CellCept (vidjeti dio 4.8).
English: Write the date of expiration of the reconstituted suspension on the bottle label.
Croatian: Zapišite datum isteka roka valjanosti rekonstituirane suspenzije na naljepnici bočice.
English: You have sex without using an effective method of contraception.
Croatian: • ako stupite u spolni odnos bez učinkovite metode kontracepcije.
English: CellCept 500 mg powder for concentrate for solution for infusion is an alternative dosage form to CellCept oral forms (capsules, tablets and powder for oral suspension) that may be administered for up to 14 days.
Croatian: CellCept 500 mg prašak za koncentrat za otopinu za infuziju alternativan je oblik doziranja oralnim oblicima lijeka CellCept (kapsule, tablete i prašak za oralnu suspenziju), koji se može primjenjivati najduže 14 dana.
English: The risk increases with total immunosuppressive load (see section 4.4).
Croatian: Rizik se povećava s ukupnom količinom imunosupresiva (vidjeti dio 4.4).
English: Take 5 mL suspension in the morning and then 5 mL suspension in the evening.
Croatian: • Uzmite 5 ml suspenzije ujutro i 5 ml suspenzije navečer.
English: • CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Croatian: • CellCept se ne smije davati bolesnicima s preosjetljivošću na mofetilmikofenolat, mikofenolatnu kiselinu ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: If neutropenia develops (absolute neutrophil count < 1.3 x 103/µl) it may be appropriate to interrupt or discontinue CellCept.
Croatian: Ako se pojavi neutropenija (apsolutni broj neutrofila < 1,3 x 103/µl), možda će biti primjereno privremeno ili potpuno prekinuti primjenu lijeka CellCept.
English: • you have any unexpected bruising or bleeding
Croatian: • ako imate bilo kakve neočekivane modrice ili krvarenje
English: No substantial alteration of MPA pharmacokinetics is anticipated and CellCept dose adjustment is not required.
Croatian: Ne očekuje se znatna promjena farmakokinetike MPA pa nije potrebna prilagodba doze lijeka CellCept.
English: • cholestyramine - used to treat high cholesterol
Croatian: • kolestiramin - koristi se za liječenje visokog kolesterola
English: CellCept is used to prevent your body rejecting a transplanted organ.
Croatian: CellCept se koristi kako bi se spriječilo da tijelo odbaci presađeni organ.
English: • Your doctor will decide the most appropriate dose based on your child's height and weight (body surface area - measured as square metres or “m2”).
Croatian: • Liječnik će odrediti odgovarajuću dozu na temelju visine i težine Vašeg djeteta (tjelesna površina mjerena u metrima kvadratnim ili “ m2”).
English: Take care not to let any powder from inside a broken capsule get into your eyes or mouth.
Croatian: Pazite da prašak koji se rasipa iz oštećenih kapsula ne dospije u Vaše oči ili usta.
English: The first dose is given to you as soon as possible after the transplant operation.
Croatian: • Prvu dozu primit ćete što je moguće prije nakon operacije presađivanja.
English: Tap the closed bottle several times to loosen the powder.
Croatian: Kucnite nekoliko puta po zatvorenoj boci da biste protresli prašak.
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 sa štetnim događajima primijećenima tijekom kliničkih ispitivanja kod ljudi, koje bolesnicima pružaju značajnije podatke o sigurnosti primjene (vidjeti dio 4.8).