natgillin/translations-raw huggingface dataset:
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. 
PRAC je zato priporočil spremembo informacij o zdravilu s posodobitvijo podatkov o teratogenih učinkih in nosečnosti ter priporočil o kontracepciji pri moških bolnikih.
The health professional educational material should contain: · The Summary of Product Characteristics · Guide for healthcare professionals 
Izobraževalno gradivo za zdravstvene delavce mora vsebovati: povzetek glavnih značilnosti zdravila, vodnik za zdravstvene delavce.
Precautions to be taken before handling or administering the medicinal product. 
Previdnostni ukrepi, ki jih je treba upoštevati pred rokovanjem z zdravilom ali pred njegovim jemanjem
• 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). 
• imate izpuščaje, otekel obraz, ustnice, jezik ali vrat ter težave z dihanjem - lahko imate resno alergijsko reakcijo na zdravilo (kot je anafilaksa, angioedem).
• gut problems including bleeding, liver problems 
• težave s prebavili, vključno s krvavitvami, težave z jetri,
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). 
Neželeni učinki so znotraj organskih sistemov razvrščeni po pogostnosti v naslednje skupine: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), z neznano pogostnostjo (iz podatkov, ki so na voljo, določitev ni mogoča).
For patients, the text should be appropriately separated for men and women. 
Pri slednjem mora biti besedilo ločeno za bolnike in bolnice.
• 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). 
• kratka sapa, kašelj, vzrok katerih je lahko bronhiektaza (stanje v katerem so dihalne poti nenormalno razširjene) ali fibroza pljuč (brazgotinjenje pljuč).
Non-melanoma skin carcinomas occurred in 3.6 % of patients; other types of malignancy occurred in 1.1 % of patients. 
Pri 3,6 % bolnikov so opazili nemelanomski kožni rak, druge vrste malignosti pa so se pojavile pri 1,1 % bolnikov.
It is recommended, however, to administer Myclausen at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA. 
Vseeno je priporočljivo, da dajemo zdravilo Myclausen vsaj eno uro pred ali tri ure po dajanju sevelamerja, zato da zmanjšamo vpliv na absorpcijo mikofenolne kisline.
Talk to your doctor if you develop a persistent cough or breathlessness 
Pogovorite se s svojim zdravnikom, če pri sebi opazite trdovratni kašelj ali zasoplost,
Norfloxacin and metronidazole 
Norfloksacin in metronidazol
It is not known whether this substance is excreted in human milk. 
Ni znano, ali se ta učinkovina v materino mleko izloča tudi pri ljudeh.
There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8). 
Poročali so tudi o posameznih primerih intersticijske pljučne bolezni in pulmonalne fibroze, nekateri od teh so bili smrtni (glejte poglavje 4.8).
Studies in animals have shown reproductive toxicity (see section 5.3). 
Študije pri živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Limit the amount of sunlight and UV light you get. 
Omejite izpostavljenost sončni svetlobi in UV-žarkom.
Heart and blood vessel problems such as: • change in blood pressure, unusual heartbeat, widening of blood vessels. 
Težave s srcem in krvnimi žilami, kot so: • spremembe krvnega tlaka, nenavaden srčni utrip, razširitev krvnih žil.
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. 
Če pri presaditvah od umrlih darovalcev pred začetkom zdravljenja ni mogoče opraviti dveh testov v razmiku 8-10 dni (zaradi časovnih omejitev organov za presaditev), je treba test nosečnosti opraviti neposredno pred začetkom zdravljenja, naslednji test pa 8-10 dni po prvem.
Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity. 
Telmisartan spreminja izločanje mikofenolne kisline tako, da okrepi izražanje receptorja PPAR gama (PPAR - peroxisome proliferator-activated receptor), kar posledično okrepi izražanje in aktivnost encima UGT1A9.
The educational materials should be implemented within four months after completion of this procedure and shall contain the following key elements: 
Izobraževalna gradiva morajo biti implementirana v štirih mesecih po zaključku tega postopka.
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy; 
Mofetilmikofenolat je močan humani teratogen s povečanim tveganjem za spontani splav in kongenitalne malformacije v primeru izpostavljenosti med nosečnostjo;
A minor acylglucuronide (AcMPAG) is also formed. 
Pri tem se tvori tudi nekaj acilglukuronida (AcMPAG).
The recommended dose is 600 mg per taken twice a day. 
Priporočeni odmerek je 600 mg/m dvakrat na dan.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey. 
Organi hematopoetskega in limfatičnega sistema so bili primarni organi, ki so bili prizadeti v toksikoloških študijah mofetilmikofenolata, ki so jih izvajali na podganah, miših, psih in opicah.
Cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants. 
O primerih hepatitisa zaradi reaktivacije hepatitisa B ali hepatitisa C so poročali pri bolnikih nosilcih, ki so bili zdravljeni z imunosupresivi.
If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Myclausen. 
Če karkoli izmed naštetega velja za vas (ali ste negotovi), se nemudoma pogovorite s svojim zdravnikom, preden vzamete zdravilo Myclausen.
Physicians should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy. 
Zdravniki morajo zagotoviti, da bolnice, ki jemljejo mofetilmikofenolat, razumejo tveganje za škodo otroku, nujnost uporabe učinkovite kontracepcije in nujnost, da se nemudoma posvetujejo s svojim zdravnikom, če obstaja možnost, da je prišlo do zanositve.
Patients taking Myclausen should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year. 
Med zdravljenjem z zdravilom Myclausen moramo napraviti preiskave celotne krvne slike enkrat na teden prvi mesec, dvakrat mesečno v drugem in tretjem mesecu in nato enkrat mesečno v prvem letu.
MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. 
Mikofenolna kislina je močan, selektivni, nekompetitivni in reverzibilni zaviralec inozin-monofosfat-dehidrogenaze in tako zavira de novo sintezo gvanozinskih nukleotidov, brez vključevanja v DNA.
Patients will be informed that they should not stop taking mycophenolate mofetil but must contact their doctor immediately. 
Bolnice bodo obveščene, da ne smejo prenehati z jemanjem mofetilmikofenolata, ampak da morajo nemudoma obvestiti zdravnika.
These are insufficient to make dosage recommendations and therefore use in this age group is not recommended. 
Ti so nezadostni za navodila o priporočenem odmerjanju, zato uporaba zdravila Myclausen v tej starostni skupini ni priporočljiva.
Other in vitro tests for detection of gene mutation did not demonstrate genotoxic activity. 
Drugi in vitro testi za določanje genskih mutacij niso pokazali genotoksičnosti.
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. 
V primerih trajne klinično pomembne hipogamaglobulinemije je treba razmisliti o primernem kliničnem ukrepu, upoštevajoč močan citostatični učinek, ki ga ima mikofenolna kislina na limfocite T in B.
Other medicines and Myclausen 
Druga zdravila in zdravilo Myclausen
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete nosečnost, se pred jemanjem tega zdravila posvetujte z zdravnikom ali s farmacevtom.
• If you have any unexpected bruising or bleeding 
• če imate kakršnekoli nepričakovane podplutbe ali krvavitve,
• Swallow your capsules whole with a glass of water. 
• Pogoltnite cele kapsule s kozarcem vode.
It is recommended to monitor MPA exposure levels and to adjust Myclausen doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly. 
Priporočljivo je spremljanje ravni izpostavljenosti mikofenolni kislini in prilagoditev odmerkov zdravila Myclausen za ohranitev klinične učinkovitosti, kadar sočasno dajemo rifampicin.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. 
Mofetilmikofenolat ni vplival na plodnost podganjih samcev pri peroralnih odmerkih do 20 mg/kg/dan.
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. 
Razložil bo, da kljub pomembnosti vodnika ta ne vsebuje vseh podatkov o mofetilmikofenolatu in da je zato treba natančno prebrati tudi povzetek glavnih značilnosti zdravila (za zdravstvene delavce) in navodilo za uporabo (za bolnike), ki sta priložena.
Treatment during rejection episodes 
Zdravljenje med zavrnitveno reakcijo
MPA AUC values across age groups were similar in the early and late posttransplant period. 
Vrednosti AUC mikofenolne kisline so bile v starostnih skupinah podobne v začetnem in poznejšem obdobju po presaditvi.
Multidrug resistance protein 1 (MDR1) is also able to transport MPA, but its contribution seems to be confined to the absorption process. 
Protein za multiplo odpornost na zdravila 1 (MDR1 - Multidrug resistance protein 1) je prav tako lahko prenašalec mikofenolne kisline, vendar se zdi, da prispeva le k absorpciji.
6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Treatment will continue for as long as you need to prevent you from rejecting your transplant organ. 
Z zdravljenjem boste nadaljevali toliko časa, kolikor bo potrebno za preprečitev zavrnitve vašega presadka.
Myclausen with food and drink Taking food and drink has no effect on your treatment with Myclausen. 
Zdravilo Myclausen skupaj s hrano in pijačo Jemanje skupaj s hrano in pijačo nima učinka na zdravljenje z zdravilom Myclausen.
• tremor, muscle spasms, convulsions 
• tremor, mišični krči, konvulzije,
Patients receiving Myclausen should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression. 
Bolnikom, ki prejemajo zdravilo Myclausen, je treba naročiti, da morajo takoj poročati o kakršnem koli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih depresije kostnega mozga.
Tablet core 
Jedro tablet:
In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms. 
V nekaj od teh primerov je zamenjava zdravila Mofetilmikofenolata za drugi imunosupresiv povzročila izboljšanje respiratornih simptomov.
What you need to know before you take Myclausen 
Kaj morate vedeti, preden boste vzeli zdravilo Myclausen
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 %. 
Pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno dajanje mofetilmikofenolata in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0-12 h) za 18 % do 70 %.
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression. 
V splošnem je lahko pri starejših bolnikih (starih 65 let ali več) zaradi imunosupresije nevarnost za neželene učinke povečana.
It will provide details about the nature and magnitude of the risk, in line with the information provided in the SmPC. 
Opisane bodo podrobnosti o naravi in velikosti tveganja v skladu s podatki v povzetku glavnih značilnosti zdravila.
• azathioprine or other medicines which suppress your immune system (given after a transplant operation) 
• azatioprin ali druga zdravila, ki zavirajo imunski sistem (uporabljajo se po presaditveni operaciji),
If neutropenia develops, dosing with Myclausen should be interrupted or the dose reduced (see section 4.4). 
Če se pojavi nevtropenija, je treba odmerjanje zdravila Myclausen prekiniti ali odmerek zmanjšati (glejte poglavje 4.4).
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. 
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.
The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8 %) were minimal and are not considered clinically significant. 
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.
Myclausen reduces your body's defences. 
Zdravilo Myclausen zmanjša obrambno sposobnost vašega organizma.
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. 
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.
Nervous system problems such as: 
Težave z živčevjem, kot so:
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in section 6). 
• če ste alergični (preobčutljivi) na mofetilmikofenolat, mikofenolno kislino ali katerokoli sestavino tega zdravila (navedeno v poglavju 6);
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. 
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.
Driving and using machines Myclausen is not likely to affect you being able to drive or use any tools or machines. 
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.
Other problems such as: • weight loss, gout, high blood sugar, bleeding, bruising. 
Druge težave, kot so: • izguba telesne mase, protin, visok krvni sladkor, krvavitve, modrice.
MPA at clinically relevant concentrations is 97 % bound to plasma albumin. 
V klinično relevantnih koncentracijah je mikofenolna kislina 97 % vezana na plazemske albumine.
• 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. 
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.
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 
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:
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). 
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).
This includes diarrhoea, infections, fewer white cells and fewer red cells in the blood. 
Ti vključujejo drisko, okužbe ter zmanjšano število belih in rdečih krvnih celic.
• 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. 
• Prvi peroralni odmerek zdravila Myclausen boste prejeli vsaj 4 dni po presaditvenem posegu in takoj, ko boste zdravila lahko jemali peroralno.
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). 
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).
The following areas should be covered in these guides: 
Vodnika morata pokrivati naslednja področja:
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. 
Zdravila Myclausen zato ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin-gvanin-fosforibozil-transferaze (HGPRT), kot sta Lesch-Nyhlanov in Kelley-Seegmillerjev sindrom.
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. 
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.
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. 
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.
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (2327%) in the unborn baby. 
Mikofenolat zelo pogosto povzroči spontani splav (50 %) in hude prirojene napake (23-27 %) pri nerojenih otrocih.
• If you have ever had a problem with your digestive system such as a stomach ulcer 
• če ste kdaj imeli težave s prebavili, kot je rana na želodcu,
EU/1/10/647/004 (300 hard capsules) 
EU/1/10/647/004 (300 trdih kapsul)
• antacids or proton pump inhibitors (used for acid problems in your stomach such as indigestion) 
• antacide ali zaviralce protonske črpalke (uporabljajo se pri težavah s kislino v želodcu, kot je dispepsija),
• you have any unexpected bruising or bleeding 
• imate nepričakovane podplutbe ali krvavitve,
Multiple dosing of mycophenolate mofetil in patients with severe chronic renal impairment has not been studied. 
Večkratnega odmerjanja mofetilmikofenolata pri bolnikih s hudo kronično ledvično okvaro še niso proučevali.
However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30 % following a single dose of mycophenolate mofetil. 
Kombinacija norfloksacina in metronidazola pa je zmanjšala izpostavljenost mikofenolni kislini za približno 30 % po enkratnem odmerku mofetilmikofenolata.
If you need to have a vaccine (a live vaccine) while taking Myclausen, talk to your doctor or pharmacist first. 
Če se morate cepiti (z živim cepivom), medtem ko jemljete zdravilo Myclausen, se prej pogovorite z zdravnikom ali farmacevtom.
Common Skin cancer, benign neoplasm of skin 
zelo pogosti pogosti kožni rak, benigna neoplazma kože
As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of mycophenolate mofetil is correlated with MPA concentration. 
Kot je razvidno iz supresije akutne zavrnitvene reakcije po transplantaciji ledvice, je imunosupresivno delovanje mofetilmikofenolata povezano s koncentracijo mikofenolne kisline.
All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4). 
Pri vseh bolnikih s presadki je povečana nevarnost oportunističnih okužb, nevarnost narašča z zvečano stopnjo imunosupresije (glejte poglavje 4.4).
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. 
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.