FrancophonIA/ELRC3.0 huggingface dataset:
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 su neke nuspojave u ovoj dobnoj skupini (vidjeti dio 4.8) češće 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: Patients taking Myfenax 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 Myfenax 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: The proportion of patients with CMV viraemia/syndrome was 13.5%.
Croatian: Udio bolesnika oboljelih od CMV viremije/sindroma iznosio je 13,5 %.
English: • change of the shape of certain white blood cells
Croatian: • promjena oblika određenih bijelih krvnih stanica
English: Your treatment is started and monitored by a doctor who is specialised in transplants.
Croatian: Vaše liječenje će započeti i pratiti liječnik specijaliziran za presađivanje organa.
English: • high level of cholesterol and/or lipids in the blood
Croatian: • visoka razina kolesterola i/ili lipida u krvi
English: • Abnormalities of the eye (e.g. coloboma);
Croatian: • abnormalnosti oka (npr. kolobom);
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (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: Pregnancy, contraception and breast-feeding Contraception in women taking Myfenax
Croatian: Trudnoća, kontracepcija i dojenje Kontracepcija u žena koje uzimaju Myfenax
English: Avoid contact with any powder that spills out from damaged capsules.
Croatian: Ne dodirujte prašak koji se rasipa iz oštećenih kapsula.
English: Talk to your doctor if you develop a persistent cough or breathlessness.
Croatian: Razgovarajte s Vašim liječnikom u slučaju pojave trajnog kašlja ili nedostatka zraka.
English: • you have a sign of infection such as a fever or sore throat.
Croatian: • imate znak infekcije poput vrućice ili grlobolje.
English: • decrease in the number of white blood cells, platelets or red blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness
Croatian: • smanjeni broj bijelih krvnih stanica, krvnih pločica ili crvenih krvnih stanica, što može povećati rizik od infekcija, modrica, krvarenja, nedostatka zraka i slabosti
English: The MAH shall ensure that in each MS where Myfenax is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Myfenax are provided with the following educational package:
Croatian: Nositelj odobrenja pobrinut će se da u svim državama članicama u kojima se Myfenax nalazi na tržištu, svi zdravstveni radnici i bolesnici za koje se očekuje da će propisivati, izdavati ili primjenjivati Myfenax dobiju sljedeći paket edukacijskih materijala:
English: Myfenax should not be used at all in children under 2 years old.
Croatian: Myfenax se ne smije koristiti u djece ispod 2 godine.
English: • Your womb (uterus) has been removed by surgery (hysterectomy).
Croatian: • Vaša maternica (uterus) je odstranjena operacijom (histerektomija).
English: • Guide for patients
Croatian: • Vodič za bolesnike
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 incidenciji zloćudnih bolesti u odnosu na jednogodišnje podatke.
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Croatian: Prijavljene su reakcije preosjetljivosti, uključujući angioneurotski edem i anafilaktičku reakciju.
English: • decrease in the number of certain white blood cells (neutropenia)
Croatian: • smanjeni broj određenih bijelih krvnih stanica (neutropenija)
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: Other medicines and Myfenax
Croatian: Drugi lijekovi i Myfenax
English: • bacterial infections usually resulting in a serious lung disorder (tuberculosis, atypical mycobacterial infection)
Croatian: • bakterijske infekcije koje obično rezultiraju ozbiljnim poremećajem pluća (tuberkuloza, atipična mikobakterijska upala)
English: If neutropenia develops (absolute neutrophil count <°1.3°x 103/°µl) it may be appropriate to interrupt or discontinue Myfenax.
Croatian: Ako se pojavi neutropenija (apsolutni broj neutrofila < 1,3 x 103/µl), možda će biti primjereno privremeno ili potpuno prekinuti primjenu Myfenaxa.
English: • decrease in the number of all blood cells, increase in the number of white blood cells
Croatian: • smanjeni broj svih krvnih stanica, povećani broj bijelih krvnih stanica
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: What Myfenax looks like and contents of the pack
Croatian: Kako Myfenax izgleda i sadržaj pakiranja
English: If a capsule breaks open accidentally, wash any powder from your skin with soap and water.
Croatian: Ako se kapsula slučajno otvori, kožu na koju je dospio prašak operite sapunom i vodom.
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: 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).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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: Therefore you should limit your exposure to sunlight and ultraviolet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Croatian: Zato prilikom izlaganja sunčevu svjetlu i ultraljubičastim (UV) zrakama nosite odgovarajuću zaštitnu odjeću i upotrebljavajte kremu za zaštitu od sunca s visokim zaštitnim faktorom.
English: • inflammation of the tissue that lines the inner wall of the abdomen and covers most of the abdominal organs
Croatian: • upala tkiva koje oblaže unutarnju stijenku trbuha i pokriva većinu organa u trbuhu
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: Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Croatian: Ozbiljne, po život opasne infekcije, uključujući meningitis, endokarditis, tuberkulozu i atipičnu mikobakterijsku infekciju.
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 povezane s liječenjem bile su učestalije u pedijatrijskoj populaciji nego kod odraslih, a osobito kod djece mlađe od 6 godina: proljev, sepsa, leukopenija, anemija i infekcija.
English: However, keep taking Myfenax until you see him or her.
Croatian: Međutim, nastavite uzimati Myfenax sve dok ga ne posjetite.
English: Pharmacotherapeutic group: immunosuppressive agents ATC code: LO4A A06
Croatian: Farmakoterapijska skupina: imunosupresivi, ATK oznaka: L04AA06
English: Do not stop taking your medicine unless your doctor tells you to.
Croatian: Nemojte prestati uzimati lijek ako Vam to ne kaže Vaš liječnik.
English: Do not stop taking Myfenax because you feel better.
Croatian: Nemojte prestati uzimati Myfenax čak i ako se osjećate bolje.
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: • decrease in the amount of antibodies in the blood
Croatian: • smanjena količina protutijela u krvi
English: • if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
Croatian: - ako opazite bilo kakve simptome infekcije (npr. vrućicu, grlobolju), neočekivane modrice i/ili krvarenje.
English: Do not stop taking your medicine unless you have discussed this with your doctor first.
Croatian: Nemojte prestati uzimati svoj lijek dok se o tome ne posavjetujete sa svojim liječnikom.
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 is recommended to monitor MPA exposure levels and to adjust Myfenax doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Croatian: Preporučuje se praćenje razina izloženosti MPA-u i prilagođavanje doze Myfenaxa prema njima radi zadržavanja kliničke djelotvornosti pri istodobnoj primjeni rifampicina.
English: Myfenax is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Croatian: Myfenax je inhibitor inozin monofosfat dehidrogenaze (IMPDH).
English: Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-27%) in the unborn baby.
Croatian: Mikofenolat vrlo često uzrokuje spontani pobačaj (50%) i teške prirođene mane (23 - 27%) kod nerođena djeteta.
English: • growth of the skin, rash, acne, hair loss
Croatian: • rast kože, osip, akne, gubitak kose
English: • Physician educational material
Croatian: • Edukacijske materijale za liječnike
English: MPA at clinically relevant concentrations is 97% bound to plasma albumin.
Croatian: MPA je pri klinički značajnim koncentracijama vezan na albumin u plazmi u iznosu od 97%.
English: Teva Operations Poland Sp. Z.o.o.
Croatian: Teva Operations Poland Sp. Z.o.o. Mogilska 80 Str.
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: • Olfactory nerve agenesis.
Croatian: • ageneze olfaktornog živca.
English: Talk to your doctor or pharmacist before taking Myfenax.
Croatian: razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka Myfenax.
English: Potential interaction
Croatian: Moguće interakcije
English: • Congenital heart disease such as atrial and ventricular septal defects;
Croatian: • prirođena srčana bolest, poput atrijskih i ventrikularnih septalnih defekata;
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 Myfenax, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Myfenax.
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 Myfenax, potrebom za kontracepcijom i kod muškaraca i kod žena te mjerama koje treba poduzeti u slučaju trudnoće tijekom liječenja lijekom Myfenax.
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 opažene značajne interakcije pri istodobnoj primjeni mofetilmikofenolata i norfloksacina ili metronidazola.
English: As general advice to minimise the risk for skin cancer, exposure to sunlight and ultraviolet (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 ultraljubičastim (UV) zrakama nošenjem zaštitne odjeće i upotrebom kreme za zaštitu od sunca s visokim zaštitnim faktorom.
English: • proliferation of the lymphatic tissue, including malignant tumours
Croatian: • pojačano stvaranje limfnog tkiva, uključujući zločudne tumore
English: • high level of uric acid in the blood, gout
Croatian: • visoka razina mokraćne kiseline u krvi, giht
English: Myfenax is a medicine that is used to suppress immune activity.
Croatian: Myfenax je lijek za suprimiranje imunološke aktivnosti.
English: • if you are planning to become pregnant, or if you get pregnant while taking Myfenax.
Croatian: - ako planirate trudnoću ili ako zatrudnite tijekom uzimanja Myfenaxa.
English: • serious inflammation of the membrane that covers the brain and spinal cord
Croatian: • ozbiljna upala ovojnice koja pokriva mozak i leđnu moždinu
English: Pharmacokinetic behaviour of mycophenolate mofetil in the elderly (≥°65 years) has not been formally evaluated.
Croatian: Starije osobe Farmakokinetika mofetilmikofenolata u starijih osoba (≥ 65 godina) nije formalno ispitivana.
English: • Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits;
Croatian: • malformacije lica, poput rascjepa usne, rascjepa nepca, mikrognatije i orbitalnog hipertelorizma;
English: • high level of potassium in the blood, low level of potassium, magnesium, calcium and/or phosphate in the blood
Croatian: • visoka razina kalija u krvi, niska razina kalija, magnezija, kalcija i/ili fosfata u krvi
English: The antibody response to other vaccines may be diminished (see also section 4.4).
Croatian: Odgovor protutijela na druga cjepiva mogao bi biti slabiji (vidjeti i dio 4.4).
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: Contraception in men taking Myfenax
Croatian: Kontracepcija u muškaraca koji uzimaju Myfenax
English: The health professional educational material should contain:
Croatian: • Paket s informacijama za bolesnike Edukacijski materijali za zdravstvene radnike moraju sadržavati:
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended doses.
Croatian: Gastrointestinalni učinci primijećeni su kod pasa na razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenim dozama.
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 mogu biti uzrokovani bronhiektazijama (stanje pri kojem su zračni putevi u plućima nenormalno prošireni) ili plućnom fibrozom (nastajanje ožiljkastog tkiva u plućima).
English: • serious inflammation of the heart and its valves
Croatian: • ozbiljna upala srca i njegovih zalisaka
English: Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Croatian: Kapsule ne otvarajte niti ne lomite te ne udišite prašak koji se nalazi unutar kapsule i izbjegavajte doticaj praška s kožom.
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: Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Croatian: Budući da su T- i B-limfociti izuzetno ovisni o de novo sintezi purina u svojoj proliferaciji, a druge vrste stanica mogu iskoristiti pomoćne puteve, citostatski učinci MPA izraženiji su na limfocite nego na druge stanice.
English: Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Croatian: Starije osobe (≥ 65 godina) u većini su slučajeva izložene povećanom riziku od nuspojava zbog imunosupresije.
English: Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.
Croatian: Myfenax se ne smije koristiti u djece i adolescenata (od 2 do 18 godina) s presađenim srcem ili jetrom.
English: What you need to know before you take Myfenax
Croatian: Što morate znati prije nego počnete uzimati Myfenax
English: • You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner`s syndrome or uterine agenesis.
Croatian: • Rođeni ste s jednim od sljedećih rijetkih urođenih stanja koja onemogućuju trudnoću: XY genotip,
English: Stopping your treatment with Myfenax may increase the chance of rejection of your transplanted organ.
Croatian: Prekid liječenja Myfenaxom može povećati mogućnost da tijelo odbaci presađeni organ.
English: Dose adjustment of Myfenax does not appear to be necessary.
Croatian: Prilagodba doze Myfenaxa nije nužno potrebna.
English: A study of the co-administration of mycophenolate mofetil (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 mycophenolate mofetil on the ovulation suppressing action of the oral contraceptives.
Croatian: Ispitivanje istodobne primjene mofetilmikofenolata (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 mofetilmikofenolata na sprječavanje ovulacije izazvano oralnim kontraceptivima.
English: • overgrowth of the gum tissue
Croatian: • prekomjerni rast zubnog mesa
English: AcMPAG is pharmacologically active and is suspected to be responsible for some of MMF´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: However, at high MPAG plasma concentrations (>°100°µg/mL), small amounts of MPAG are removed.
Croatian: Međutim, pri visokim koncentracijama MPAG-a u plazmi (> 100µg/ml) uklonjene su male količine MPAG-a.
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 mofetilmikofenolata drugim imunosupresivom rezultirala je poboljšanjem respiratornih simptoma.
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 mycophenolate.
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 mikofenolatom.
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate.
Croatian: Dostupni dokazi ne ukazuju na povećan rizik od malformacija ili spontanog pobačaja ako otac uzima mikofenolat.
English: Caution is therefore recommended when administering these drugs concomitantly with mycophenolate mofetil.
Croatian: Stoga se preporučuje oprez kada se ti lijekovi primjenjuju istodobno s mofetilmikofenolatom.
English: For contraception advice for men see section 4.6.
Croatian: Za savjete o kontracepciji za muškarce vidjeti dio 4.6. Edukacijski materijali
English: A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4°g TID), indicating that there is a significant amount of enterohepatic recirculation.
Croatian: Smanjenje AUC-a MPA od otprilike 40 % vezano je uz istodobnu primjenu kolestiramina (4 g triput dnevno), ukazuju na značajnu količinu enterohepatične recirkulacije.
English: Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.
Croatian: Myfenax se koristi u djece i adolescenata (od 2 do 18 godina) radi sprječavanje tijela da odbaci presađeni bubreg.
English: Use in special populations
Croatian: Primjena u posebnim populacijama Starije osobe
English: • The need to avoid foetal exposure: Contraceptive requirements for patients of reproductive potential prior to, during and after treatment with mycophenolate mofetil.
Croatian: • Potreba za izbjegavanjem izlaganja fetusa lijeku: Zahtjevi za primjenom kontracepcije kod bolesnika i bolesnica reproduktivne dobi prije, tijekom i nakon liječenja mofetilmikofenolatom.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Na tiskanoj uputi o lijeku mora se navesti i adresa proizvođača odgovornog za puštanje navedene serije u promet.
English: • if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na mofetilmikofenolat, mikofenolnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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.