FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Mofetilmikofenolat je bil v študijah na živalih pri koncentracijah, ki le v majhni meri presegajo terapevtske izpostavljenosti pri človeku, genotoksičen in tako tveganja za genotoksične učinke na spermije ne moremo popolnoma izključiti.
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8 %) were minimal and are not considered clinically significant.
Slovenian: Spremembe v farmakokinetiki mikofenolglukuronida (fenolnega glukuronida mikofenolne kisline) (ki ga je bilo za 8 % več) so bile minimalne in jih ne smatramo za klinično pomembne.
English: Myclausen reduces your body's defences.
Slovenian: Zdravilo Myclausen zmanjša obrambno sposobnost vašega organizma.
English: Patients receiving Myclausen should be monitored for neutropenia, which may be related to Myclausen itself, concomitant medications, viral infections, or some combination of these causes.
Slovenian: Bolnike, ki prejemajo zdravilo Myclausen, je treba skrbno nadzorovati zaradi nevtropenije, ki je lahko posledica jemanja zdravila Myclausen, sočasno uporabljenih zdravil, virusnih okužb ali nekaterih kombinacij teh vzrokov.
English: Nervous system problems such as:
Slovenian: Težave z živčevjem, kot so:
English: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in section 6).
Slovenian: • če ste alergični (preobčutljivi) na mofetilmikofenolat, mikofenolno kislino ali katerokoli sestavino tega zdravila (navedeno v poglavju 6);
English: These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive mycophenolate mofetil.
Slovenian: Te spremembe lahko pri preiskavah krvi predstavljajo ‘premik v levo' pri zorenju nevtrofilcev, kar se lahko pri imunosupresiranih bolnikih, kot so ti, ki prejemajo mofetilmikofenolat, napačno razlaga kot znak okužbe.
English: Driving and using machines Myclausen is not likely to affect you being able to drive or use any tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Myclausen vplivalo na vašo sposobnost vožnje in upravljanje z orodji ali s stroji.
English: Other problems such as: • weight loss, gout, high blood sugar, bleeding, bruising.
Slovenian: Druge težave, kot so: • izguba telesne mase, protin, visok krvni sladkor, krvavitve, modrice.
English: MPA at clinically relevant concentrations is 97 % bound to plasma albumin.
Slovenian: V klinično relevantnih koncentracijah je mikofenolna kislina 97 % vezana na plazemske albumine.
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.
Slovenian: uvod v obeh vodnikih bo informiral bralca, da je namen vodnika pojasniti, da se je treba izogibati izpostavljenosti ploda in kako kar najbolj zmanjšati tveganje za prirojene okvare in spontani splav, povezane z uporabo mofetilmikofenolata.
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
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da v vseh državah članicah, kjer je zdravilo Myclausen na tržišču, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo Myclausen, prejeli naslednja izobraževalna gradiva:
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).
Slovenian: Učinki na gastrointestinalni in renalni sistem skupaj z dehidracijo so bili opaženi tudi pri opicah, ki so prejele najvišje odmerke (sistemska izpostavljenost je bila enaka ali večja od klinične izpostavljenosti).
English: This includes diarrhoea, infections, fewer white cells and fewer red cells in the blood.
Slovenian: Ti vključujejo drisko, okužbe ter zmanjšano število belih in rdečih krvnih celic.
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.
Slovenian: • Prvi peroralni odmerek zdravila Myclausen boste prejeli vsaj 4 dni po presaditvenem posegu in takoj, ko boste zdravila lahko jemali peroralno.
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).
Slovenian: Takšne okužbe vključujejo reaktivacijo latentnega virusa, na primer reaktivacijo hepatitisa B ali hepatitisa C in okužbe, ki jih povzročijo poliomavirusi (nefropatija, povezana z virusom BK, progresivna multifokalna levkoencefalopatija (PML), povezana z virusom JC).
English: The following areas should be covered in these guides:
Slovenian: Vodnika morata pokrivati naslednja področja:
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.
Slovenian: Zdravila Myclausen zato ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin-gvanin-fosforibozil-transferaze (HGPRT), kot sta Lesch-Nyhlanov in Kelley-Seegmillerjev sindrom.
English: As can happen in patients taking this type of medicine (immune-suppressants), a very small number of Myclausen patients have developed cancer of the lymphoid tissues and skin.
Slovenian: Kot se lahko zgodi pri bolnikih, ki jemljejo takšno vrsto zdravil (zdravila za zaviranje imunske odzivnosti), se je pri zelo majhnem številu bolnikov, ki so jemali zdravilo Myclausen, pojavil rak limfatičnih tkiv in kože.
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.
Slovenian: Namen izobraževalnega programa je zagotoviti, da bi se zdravstveni delavci in bolniki zavedali teratogenosti in mutagenosti, potrebe po testih nosečnosti pred začetkom zdravljenja z zdravilom Myclausen, zahteve po kontracepciji za bolnike in bolnice ter da bi vedeli, kaj storiti v primeru zanositve med zdravljenjem z zdravilom Myclausen.
English: Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (2327%) in the unborn baby.
Slovenian: Mikofenolat zelo pogosto povzroči spontani splav (50 %) in hude prirojene napake (23-27 %) pri nerojenih otrocih.
English: • If you have ever had a problem with your digestive system such as a stomach ulcer
Slovenian: • če ste kdaj imeli težave s prebavili, kot je rana na želodcu,
English: EU/1/10/647/004 (300 hard capsules)
Slovenian: EU/1/10/647/004 (300 trdih kapsul)
English: • antacids or proton pump inhibitors (used for acid problems in your stomach such as indigestion)
Slovenian: • antacide ali zaviralce protonske črpalke (uporabljajo se pri težavah s kislino v želodcu, kot je dispepsija),
English: • you have any unexpected bruising or bleeding
Slovenian: • imate nepričakovane podplutbe ali krvavitve,
English: Multiple dosing of mycophenolate mofetil in patients with severe chronic renal impairment has not been studied.
Slovenian: Večkratnega odmerjanja mofetilmikofenolata pri bolnikih s hudo kronično ledvično okvaro še niso proučevali.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30 % following a single dose of mycophenolate mofetil.
Slovenian: Kombinacija norfloksacina in metronidazola pa je zmanjšala izpostavljenost mikofenolni kislini za približno 30 % po enkratnem odmerku mofetilmikofenolata.
English: If you need to have a vaccine (a live vaccine) while taking Myclausen, talk to your doctor or pharmacist first.
Slovenian: Če se morate cepiti (z živim cepivom), medtem ko jemljete zdravilo Myclausen, se prej pogovorite z zdravnikom ali farmacevtom.
English: Common Skin cancer, benign neoplasm of skin
Slovenian: zelo pogosti pogosti kožni rak, benigna neoplazma kože
English: As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of mycophenolate mofetil is correlated with MPA concentration.
Slovenian: Kot je razvidno iz supresije akutne zavrnitvene reakcije po transplantaciji ledvice, je imunosupresivno delovanje mofetilmikofenolata povezano s koncentracijo mikofenolne kisline.
English: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Slovenian: Pri vseh bolnikih s presadki je povečana nevarnost oportunističnih okužb, nevarnost narašča z zvečano stopnjo imunosupresije (glejte poglavje 4.4).
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.
Slovenian: Imetnik dovoljenja za promet se mora z nacionalnim organom, pristojnim za zdravila, dogovoriti o vsebini in obliki izobraževalnega programa in vprašalnika o spremljanju nosečnosti, vključno s komunikacijskim medijem, načinom distribucije in vsemi drugimi vidiki programa.
English: The educational materials will reinforce the warnings about the teratogenicity of mycophenolate, provide advice on contraception before therapy is started and guidance on the need for pregnancy testing.
Slovenian: Izobraževalno gradivo bo okrepilo opozorila o teratogenosti mofetilmikofenolata, zagotovilo nasvet glede kontracepcije pred začetkom zdravljenja in dalo navodila glede potrebe po testiranju nosečnosti.
English: Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
Slovenian: O primerih prevelikega odmerjanja mofetilmikofenolata so poročali v kliničnih preskušanjih in med trženjem zdravila.
English: Blood and immune system
Slovenian: Krvni in imunski sistem
English: • Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
Slovenian: Nasvet o postopku, če se nosečnost pojavi (ali sumi nanjo) med ali kmalu po zdravljenju z mofetilmikofenolatom.
English: Pregnancy whilst taking mycophenolate must be avoided.
Slovenian: V času jemanja mikofenolata se je treba izogniti nosečnosti.
English: • sinus problems.
Slovenian: • težave s sinusi.
English: Tel.: 0049 (0)30 744 60 12 Fax: 0049 (0)30 744 60 41
Slovenian: Tel.: 0049 (0)30 744 60 12 Faks: 0049 (0)30 744 60 41
English: In addition, the text relating to women should explain the pregnancy test requirements prior to and during therapy with mycophenolate mofetil; including the advice for two negative pregnancy tests prior to starting therapy and the importance of the timing of these tests.
Slovenian: Dodatno morajo biti v besedilu za bolnice pojasnjene zahteve po testiranju nosečnosti pred in med zdravljenjem z mofetilmikofenolatom, vključno z nasveti za dva negativna testa nosečnosti pred začetkom zdravljenja in pomembnostjo časovne razporeditve teh testov.
English: It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4).
Slovenian: Pričakuje se, da bi preveliko odmerjanje mofetilmikofenolata lahko povzročilo čezmerno supresijo imunskega sistema in povečalo dovzetnost za okužbe in supresijo kostnega mozga (glejte poglavje 4.4).
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Slovenian: Poročali so o preobčutljivostnih reakcijah, vključno z angionevrotičnim edemom in anafilaktično reakcijo.
English: In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30 % lower and Cmax approximately 40 % lower compared to the late post-transplant period (3-6 months post-transplant).
Slovenian: V zgodnjem obdobju po presaditvi (do 40. dneva po presaditvi) je srednja AUC mikofenolne kisline pri bolnikih z ledvičnim, srčnim ali jetrnim presadkom za približno 30 % manjša, Cmax pa za približno 40 % manjša v primerjavi s poznejšim obdobjem po presaditvi (3 do 6 mesecev po presaditvi).
English: Male patients of reproductive potential should be made aware of and discuss the potential risk of fathering a child with a qualified health-care professional.
Slovenian: Bolniki, ki lahko spočnejo otroka, se morajo zavedati možnih tveganj spočetja med zdravljenjem in se o njih pogovoriti z usposobljenim zdravstvenim delavcem.
English: Mycophenolate is a powerful human teratogen.
Slovenian: Mofetilmikofenolat je močan humani teratogen.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom ali farmacevtom.
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.
Slovenian: Dve študiji genotoksičnosti (in vitro mišji limfomski preskus ter in vivo mišji mikronukleosni test kostnega mozga) sta pokazali, da lahko mofetilmikofenolat povzroči prelome kromosomov.
English: Patients taking oral contraceptives
Slovenian: Bolnice, ki jemljejo peroralne kontraceptive
English: Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Slovenian: Ne odpiraje ali drobite kapsul, ne vdihujte prahu, ki je v kapsulah in ne dovolite, da pride prah v stik s kožo.
English: Pregnancy, contraception and breast-feeding
Slovenian: Nosečnost, kontracepcija in dojenje
English: Trimethoprim/sulfamethoxazole No effect on the bioavailability of MPA was observed.
Slovenian: Trimetoprim/sulfametoksazol Vplivov na biološko uporabnost mikofenolne kisline niso opazili.
English: Do not take Myclausen
Slovenian: Ne jemljite zdravila Myclausen
English: Do not break or crush the tablets.
Slovenian: Tablet ne lomite in jih ne drobite.
English: Additional amendments have been made regarding use of contraception in women and pregnancy testing, to clarify the requirements.
Slovenian: Za pojasnitev zahtev so bile dodane spremembe glede uporabe kontracepcije pri bolnicah in testov nosečnosti.
English: Most (about 87 %) of the administered dose is excreted in the urine as MPAG.
Slovenian: Večina (87 %) zaužitega odmerka se je izločila v urin v obliki mikofenolglukuronida.
English: Aciclovir
Slovenian: Aciklovir
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.
Slovenian: Razloženo bo, da bo v pogovoru med zdravnikom in bolnico določeno pravilno soslednje dogodkov glede na oceno razmerja med koristjo in tveganjem za posamezen primer.
English: Oral Myclausen should be initiated within 72 hours following transplantation.
Slovenian: Peroralno dajanje zdravila Myclausen je treba uvesti v 72 urah po presaditvi.
English: Each carton contains either 50 or 150 tablets.
Slovenian: Vsaka škatla vsebuje 50 ali 150 tablet.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Myclausen film-coated tablets should be handled with care.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Filmsko obložene tablete Myclausen je treba uporabljati previdno.
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.
Slovenian: Zaradi zanesljivih kliničnih dokazov, ki kažejo na visoko tveganje za splav in kongenitalne malformacije, če se mofetilmikofenolat uporablja v nosečnosti, je treba poskrbeti za ukrepe, da se izognemo nosečnosti med zdravljenjem.
English: Serum levels of LH, FSH and progesterone were not significantly affected.
Slovenian: Koncentracije LH, FSH in progesterona v serumu niso bile pomembno spremenjene.
English: PRCA may resolve with dose reduction or cessation of Myclausen therapy.
Slovenian: PRCA je lahko reverzibilna z zmanjšanjem odmerka ali s prekinitvijo zdravljenja z zdravilom Myclausen.
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Myclausen capsules.
Slovenian: Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, kapsul Myclausen ne smemo odpreti ali drobiti, da se izognemo vdihavanju ali neposrednemu stiku praška v Myclausen kapsulah s kožo ali sluznico.
English: If you forget to take Myclausen
Slovenian: Če ste pozabili vzeti zdravilo Myclausen
English: Separate guides for healthcare professionals and patients should be provided.
Slovenian: Pripraviti je treba poseben vodnik za zdravstvene delavce in poseben vodnik za bolnike.
English: White oblong capsules.
Slovenian: Bele podolgovate kapsule
English: Myclausen is used to prevent your body rejecting a transplanted organ.
Slovenian: Zdravilo Myclausen prepreči, da bi vaše telo zavrnilo presadek.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Myclausen capsules should be handled with care.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Myclausen kapsule je treba uporabljati previdno.
English: Children may be more likely than adults to have some side effects.
Slovenian: Nekatere neželene učinke imajo otroci pogosteje kot odrasli.
English: Each carton contains either 50 or 150 film-coated tablets.
Slovenian: Vsaka škatla vsebuje 50 ali 150 filmsko obloženih tablet.
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).
Slovenian: Neklinični profil toksičnosti mofetilmikofenolata je v skladu z neželenimi učinki, ki so jih opazili pri kliničnih študijah pri ljudeh, ki so z varnostnega vidika pomembnejši (glej poglavje 4.8).
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.
Slovenian: Če ste bolnica, ki bi lahko zanosila, morate pred začetkom zdravljenja zagotoviti negativen test nosečnosti in slediti nasvetom za kontracepcijo, ki vam jih je dal vaš zdravnik.
English: It is not known if MPA is present in semen.
Slovenian: Ni znano, ali je mofetilmikofenolat prisoten v semenu.
English: If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Slovenian: Če pride do stika s praškom, je potrebno temeljito izpiranje z vodo in milom, oči izpiramo le z vodo.
English: What Myclausen looks like and contents of the pack
Slovenian: Izgled zdravila Myclausen in vsebina pakiranja
English: Passauer Pharma GmbH Eiderstedter Weg 3 14129 Berlin Germany
Slovenian: Passauer Pharma GmbH Eiderstedter Weg 3 14129 Berlin Nemčija
English: • Do not break or crush them.
Slovenian: • Ne smete jih lomiti ali drobiti.
English: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Slovenian: Ledvična okvara Bolnikom s hudo kronično ledvično okvaro (glomerulna filtracija < 25 ml/min/1,73 m2) izven obdobja neposredno po presaditvi ne dajemo odmerkov, večjih od 1 g dvakrat na dan.
English: White round film-coated tablets.
Slovenian: Bele okrogle filmsko obložene tablete
English: This include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty in sleeping, pains (such as stomach, chest, joint or muscle, pain on passing urine), headache, flu symptoms and swelling.
Slovenian: Ti vključujejo resne alergijske reakcije (kot sta anafilaksa, angioedem), povišano telesno temperaturo, močno utrujenost, motnje spanca, bolečine (bolečino v želodcu, bolečino v prsih, bolečino v sklepih ali mišicah, bolečino pri uriniranju), glavobol, gripi podobne simptome in otekline.
English: Talk to your doctor straight away before taking Myclausen:
Slovenian: Nemudoma se posvetujte s svojim zdravnikom, preden vzamete zdravilo Myclausen:
English: Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m administered orally twice daily (up to a maximum of 2 g daily).
Slovenian: Pediatrični bolniki stari od 2 do 18 let Priporočeni odmerek mofetilmikofenolata je 600 mg/m2, peroralno dvakrat na dan (do največ 2 g na dan).
English: Patients treated with immunosuppressants, including Myclausen, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Slovenian: Bolniki, ki se zdravijo z imunosupresivi, vključno z zdravilom Myclausen, imajo povečano tveganje za oportunistične okužbe (bakterijske, glivične, virusne in protozojske), smrtne okužbe in sepso (glejte poglavje 4.8).
English: The change in predose level may not accurately represent changes in overall MPA exposure.
Slovenian: Spremembe koncentracije pred naslednjim odmerkom morda niso točen pokazatelj sprememb v celokupni izpostavljenosti mikofenolni kislini.
English: These data support extrapolation of this finding to all antacids because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium and aluminium hydroxides is considerably less than when mycophenolate mofetil was co-administered with PPIs.
Slovenian: Ti podatki podpirajo ekstrapolacijo teh ugotovitev na vse antacide, saj je zmanjšanje izpostavljenosti, kadar je zdravilo mofetilmikofenolata sočasno uporabljeno z magnezijevimi in aluminijevi hidroksidi, občutno manjše v primerjavi s sočasno uporabo zdravila mofetilmikofenolata in zaviralcev protonske črpalke.
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.
Slovenian: Kontracepcija pri bolnicah, ki jemljejo zdravilo Myclausen Če ste bolnica, ki bi lahko zanosila, morate med zdravljenjem z zdravilom Myclausen uporabljati učinkovito kontracepcijsko zaščito, in sicer:
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.
Slovenian: Zato so priporočljivi naslednji previdnostni ukrepi: priporočljivo je, da med bolnikovim zdravljenjem z mofetilmikofenolatom in še vsaj 90 dni po prenehanju zdravljenja spolno aktivni bolniki ali njihove partnerke uporabljajo zanesljivo kontracepcijo.