natgillin/translations-raw huggingface dataset:
Lymphoproliferative disease or lymphoma developed in 0.6% of patients receiving mycophenolate (2 g or 3 g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year.
Limfoproliferativne bolezni ali limfomi so se pojavili pri 0, 6% bolnikov, ki so dobivali mofetilmikofenolat (2 g ali 3 g dnevno) skupaj z drugimi imunosupresivi v nadzorovanih kliničnih preskušanjih pri bolnikih z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, ki so trajala vsaj eno leto.
Three-year safety data in renal and cardiac transplant patients did not 19 reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
Triletni podatki o varnosti pri bolnikih z ledvičnim in srčnim presadkom ne kažejo nobenih nepričakovanih sprememb v incidenci malignosti v primerjavi z enoletnimi podatki.
Opportunistic infections:
19 Oportunistične okužbe:
Adverse reactions, probably or possibly related to mycophenolate, reported in  1/ 10 and in ≥ 1/ 100 to < 1/ 10 of patients treated with mycophenolate in the controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients are listed in the following table.
Neželeni učinki, ki so verjetno ali možno povezani z mofetilmikofenolatom in so se pojavili pri bolnikih, zdravljenih z mofetilmikofenolatom v nadziranih kliničnih preskušanjih bolnikov z ledvičnim (podatki za 2 g), srčnim ali jetrnim presadkom, so našteti v spodnji preglednici.
20 Adverse reactions, probably or possibly related to mycophenolate, reported in patients treated with mycophenolate in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
20 Neželeni učinki, verjetno ali možno povezani z mofetilmikofenolatom, ki so se pojavili pri bolnikih zdravljenih z mofetilmikofenolatom v kombinaciji s ciklosporinom in kortikosteroidi pri kliničnih preskušanjih bolnikov z ledvičnim, srčnim ali jetrnim presadkom.
Investigations
zelo pogosti
- Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
zvišani jetrni encimi, zvišan kreatinin v krvi, zvišana laktat - dehidrogenaza v krvi, zvišana sečnina v krvi, zvišana alkalna fosfataza v krvi, zmanjšana telesna masa
- Tachycardia
zelo pogosti
Blood and lymphatic system disorders
levkopenija, trombocitopenija, anemija
Leukopenia, thrombocytopenia, anaemia Pancytopenia, leukocytosis
pancitopenija, levkocitoza
- Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
konvulzije, hipertonija, tremor, somnolenca, miastenijski sindrom, omotica, glavobol, parestezija, sprememba okusa
- Pleural effusion, dyspnoea, cough
plevralni izliv, dispneja, kašelj
Renal and urinary disorders Skin and subcutaneous tissue disorders
bruhanje, bolečina v trebuhu, diareja, navzea
Very common Common Very common Common
pogosti
- Renal impairment - Skin hypertrophy, rash, acne, alopecia
krvavitev v prebavilih, peritonitis, ileus, kolitis, ulkus na želodcu, ulkus na dvanajstniku, gastritis, ezofagitis, stomatitis, zaprtje, dispepsija, flatulenca, kolcanje
Musculoskeletal and connective tissue disorders
Bolezni sečil
- Arthralgia
ledvična okvara
21
21 Organski sistem
Frequency
zelo pogosti
Adverse drug reactions
pogosti
Metabolism and nutrition disorders
hipertrofija kože, izpuščaj, akne, alopecija
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
hipomagnezemija, hipokalciemija, hiperholesterolemija, hiperlipidemija, hipofosfatemija, hiperurikemija, protin, anoreksija
Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
moniliaza, gastrointestinalna okužba, kandidoza, gastroenteritis, okužba, bronhitis, faringitis, sinuzitis, glivična okužba kože, kandidoza kože, vaginalna kandidoza, rinitis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplazme (vključno s cistami in polipi)
- Skin cancer, benign neoplasm of skin
kožni rak, benigna neoplazma kože
Vascular disorders General disorders and administration site conditions
hipotenzija, hipertenzija, vazodilatacija
- Hypotension, hypertension, vasodilatation - Oedema, pyrexia, chills, pain, malaise, asthenia
edem, pireksija, mrzlica, bolečina, občutek neugodja, astenija
Hepatobiliary disorders Psychiatric disorders
hepatitis, zlatenica, hiperbilirubinemija
- Hepatitis, jaundice, hyperbilirubinaemia - Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
agitacija, stanje zmedenosti, depresija, anksioznost, nenormalno mišljenje, nespečnost
Gastrointestinal: colitis including cytomegalovirus colitis, (common), pancreatitis, (common) and intestinal villous atrophy.
22 Prebavila: kolitis, vključno s kolitisom, ki ga povzroča citomegalovirus (pogosti), pancreatitis (pogosti) in atrofija črevesne sluznice.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of patients taking Mycophenolate mofetil Teva is advised (see section 4.4).
Poročali so tudi o agranulocitozi (občasni) in nevtropeniji, zato je priporočljivo bolnike, ki jemljejo zdravilo Mofetilmikofenolat Teva, redno spremljati (glejte poglavje 4. 4).
There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate, some of which have been fatal.
Pri bolnikih, ki so se zdravili z mofetilmikofenolatom, so poročali o primerih aplastične anemije in depresije kostnega mozga, nekateri od teh so bili smrtni.
22 Hypersensitivity: hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Preobčutljivost: poročali so o preobčutljivostnih reakcijah, vključno z angionevrotičnim edemom in anafilaktično reakcijo.
If neutropenia develops, dosing with Mycophenolate mofetil Teva should be interrupted or the dose reduced (see section 4.4).
Če se pojavi nevtropenija, je treba odmerjanje zdravila Mofetilmikofenolat Teva prekiniti ali odmerek zmanjšati (glejte poglavje 4. 4).
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA).
Mofetilmikofenolat je 2- morfolinoetilni ester mikofenolne kisline.
The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to intravenous mycophenolate mofetil.
Srednja biološka uporabnost peroralne oblike mofetilmikofenolata, temelječa na AUC mikofenolne kisline,
Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal transplant patients.
23 znaša 94% glede na intravenske oblike mofetilmikofenolata.
However, MPA C max was decreased by 40% in the presence of food.
Hrana na obseg absorpcije mofetilmikofenolata (AUC mikofenolne kisline), če ga dajemo v odmerkih 1, 5 g dvakrat na dan bolnikom s presajeno ledvico, ne vpliva, zmanjša pa največjo plazemsko koncentracijo (Cmax) mikofenolne kisline za približno 40%.
A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that these is a significant amount of enterohepatic recirculation.
Holestiramin v odmerku 4 g 3- krat na dan zmanjša AUC mikofenolne kisline za približno 40%, kar potrjuje veliko stopnjo ponovnega enterohepatičnega obtoka.
23 A negligible amount of substance is excreted as MPA (< 1% of dose) in the urine.
Zanemarljiva količina učinkovine (manj kot 1% odmerka) se kot mikofenolna kislina izloča v urin.
However, at high MPAG plasma concentrations (> 100  g/ ml), small amounts of PAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 µg/ ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplants patients had mean MPA AUCs approximately 30% lower and C max approximately 40% lower compared to the late post-transplant period (3 – 6 months post-transplant).
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).
However, the mean single dose MPAG AUC was 3 – 6 -fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
To se je ujemalo z znanim izločanjem mikofenolglukuronida skozi ledvice.
Mean plasma MPAG AUC (0- 12h) was 2 – 3-fold higher than in post-transplant patients without delayed graft function.
Srednja AUC (0- 12 ur) mikofenolglukuronida pa je bila 2 - do 3- krat večja kot pri bolnikih brez zapoznelega delovanja ledvičnega presadka.
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients given 600 mg/ m2 mycophenolate mofetil orally twice daily.
Ti odmerki so dali podobne vrednosti AUC
This dose achieved MPA AUC values similar to those seen in adult renal transplant patients receiving mycophenolate at a dose of 1 g BID in the early and late post-transplant period.
24 mikofenolne kisline kot pri odraslih bolnikih z ledvičnim presadkom, ki so prejemali mofetilmikofenolat v odmerku 1 g dvakrat na dan v začetnem in poznejšem obdobju po presaditvi.
The pharmacokinetics of oral contraceptives were unaffected by co administration of mycophenolate (see also section 4.5).
Sočasno jemanje mofetilmikofenolata in peroralnih kontraceptivov ni vplivalo na farmakokinetiko peroralnih kontraceptivov (glejte tudi poglavje 4. 5).
A study of the co administration of mycophenolate (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 on the ovulation suppressing action of the oral contraceptives.
V treh zaporednih menstruacijskih ciklih niso opazili klinično pomembnih vplivov mofetilmikofenolata na supresijo ovulacije peroralnih kontraceptivov.
5.3 Preclinical safety data 24 In experimental models, mycophenolate mofetil was not tumourigenic.
Mofetilmikofenolat v eksperimentalnih modelih ni bil kancerogen.
The highest dose tested in the animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or C max) observed in renal transplant patients as the recommended clinical dose of 2 g/ day and 1.3 – 2 times the systemic exposure (AUC or C max) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
Najvišji preizkušani odmerek v živalskih študijah karcinogenosti je povzročil približno 2 - do 3- krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih z ledvičnim presadkom, ki so prejemali priporočeni klinični odmerek 2 g na dan, in 1, 3 - do 2- krat večjo sistemsko izpostavljenost (AUC ali Cmax) kot pri bolnikih s srčnim presadkom, ki so prejemali priporočeni klinični odmerek 3 g na dan.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg kg-1 day-1.
Mofetilmikofenolat ni vplival na fertilnost podganjih samcev pri peroralnih odmerkih do 20 mg• kg- 1• dan- 1.
The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/ day in renal transplant patients and 1.3 – 2 times the clinical exposure at the recommended clinical dose of 3 g/ day in cardiac transplant patients.
Sistemska izpostavljenost pri tem odmerku predstavlja 2 - do 3- kratno klinično izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan pri bolnikih z ledvičnim presadkom, in 1, 3 - do 2- kratno klinično izpostavljenost pri priporočenem kliničnem odmerku 3 g na dan pri bolnikih s srčnim presadkom.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg kg-1 day-1 caused malformations (including anophthalmia, agnathia and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
V študijah fertilnosti in reproduktivnosti so peroralni odmerki po 4, 5 mg• kg- 1• dan- 1 pri podganjih samicah povzročili malformacije (vključno z anoftalmijo, agnatijo in hidrocefalijo) pri prvi generaciji potomcev, pri materah pa škodljivih učinkov ni bilo.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg kg-1  day-1 (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg kg-1 day-1 (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
V študijah teratogenosti pri podganah in kuncih so se pojavile malformacije in resorpcija zarodka pri odmerkih 6 mg• kg- 1• dan- 1 pri podganah (vključno z anoftalmijo, agnatijo in hidrocefalijo) ter pri odmerkih 90 mg• kg- 1• dan- 1 pri kuncih (vključno s kardiovaskularnimi motnjami in motnjami delovanja ledvic, kot so ektopija srca in ledvic ter preponska in popkovna kila), pri materah pa škodljivih učinkov ni bilo.
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
These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/ day for renal transplant recipients.
25 študijah mofetilmikofenolata, ki so jih izvajali na podganah, miših, psih in opicah.
Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended doses.
Učinki so se pojavili pri sistemski izpostavljenosti, ki je bila enaka ali manjša kot klinična izpostavljenost pri priporočenem odmerjanju 2 g na dan pri bolnikih z ledvičnim presadkom.
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).
Pri psih so se pojavili gastrointestinalni neželeni učinki pri sistemski izpostavljenosti, ki je bila enaka ali manjša od klinične izpostavljenosti pri priporočenem odmerjanju.
Microcrystalline cellulose Povidone K-30 Magnesium stearate Croscarmellose sodium 25 Tablet coat:
Jedro tablete: mikrokristalna celuloza povidon K- 30 magnezijev stearat premrežen natrijev karmelozat
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Obloga tablete: hipromeloza (E464) titanov dioksid (E171) makrogol smukec indigotin (E132) črni železov oksid (E172) rdeči železov oksid (E172)
Transparent PVC/ PVdC-aluminium blisters in pack sizes of 50 or 150 tablets per carton.
Prozorni PVC/ PVdC – aluminijasti pretisni omoti v pakiranjih po 50 ali 150 tablet v škatli.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Mycophenolate mofetil Teva film-coated tablets should not be crushed.
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, filmsko obloženih tablet zdravila Mofetilmikofenolat Teva ne smemo drobiti.
EU/ 1/ 07/ 439/ 003 (50 tablets) EU/ 1/ 07/ 439/ 004 (150 tablets)
EU/ 1/ 07/ 439/ 003 (50 tablet) EU/ 1/ 07/ 439/ 004 (150 tablet)
26 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
Debrecen H-4042 Hungary
Debrecen H- 4042 Madžarska
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő Táncsics Mihály út 82 Hungary
TEVA Pharmaceutical Works Private Limited Company H- 2100 Gödöllő Táncsics Mihály út 82 Madžarska
Swensweg 5 2031 GA Haarlem The Netherlands
Swensweg 5 2031 GA Haarlem Nizozemska
 OTHER CONDITIONS
Sistem farmakovigilance
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0, dated September 2006 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
29 Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2. 0, september 2006, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
29 Risk Management Plan No description of Risk Management Plan has been provided by the applicant.
Načrt upravljanja tveganja Predlagatelj ni predložil opisa načrta upravljanja tveganja.
Since the application concerns a generic with a reference medicinal product for which no safety concern requiring additional risk minimisation activities has been identified this approach is considered acceptable.
Tak pristop je sprejemljiv, saj vloga zadeva generično zdravilo z referenčnim zdravilom, pri katerem ugotovljeni varnostni profil ne zahteva dodatnih dejavnosti za zmanjševanje tveganja.
PSURs The PSUR submission schedule for both strengths should follow the PSUR schedule for the reference products.
PSURi Načrt oddajanja PSUR- ov za obe jakosti mora biti usklajen z načrtom oddajanja PSUR- ov za referenčno zdravilo.
31 A. LABELLING
OZNAČEVANJE
100 capsules 300 capsules
100 kapsul 300 kapsul
Read the package leaflet before use
Za peroralno uporabo Pred uporabo preberite priloženo navodilo.
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Zdravilo Mofetilmikofenolat Teva kapsule je treba uporabljati previdno Kapsul ne odpirajte in ne drobite Izogibajte se vdihavanju ali neposrednemu stiku praška s kožo
OTHER
5. ¸ DRUGI PODATKI
50 tablets 150 tablets
50 tablet 150 tablet
Do not crush the tablets.
Zdravilo Mofetilmikofenolat Teva tablete je treba uporabljati previdno Tablet nedrobite.
38 B. PACKAGE LEAFLET
NAVODILO ZA UPORABO
Mycophenolate mofetil Teva 250 mg hard capsules Mycophenolate mofetil
Mofetilmikofenolat Teva 250 mg trde kapsule mofetilmikofenolat
1.
Navodilo vsebuje:
Further information
1 Kaj je zdravilo Mofetilmikofenolat Teva in za kaj ga uporabljamo 2 Kaj morate vedeti, preden boste vzeli zdravilo Mofetilmikofenolat Teva 3 Kako jemati zdravilo Mofetilmikofenolat Teva 4 Možni neželeni učinki 5 Shranjevanje zdravila Mofetilmikofenolat Teva 6 Dodatne informacije
WHAT MYCOPHENOLATE MOFETIL TEVA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO MOFETILMIKOFENOLAT TEVA IN ZA KAJ GA UPORABLJAMO
It is used in combination with other medicines with a similar function (i. e. ciclosporin and corticosteroids).
Zdravilo Mofetilmikofenolat Teva uporabljamo skupaj z drugimi zdravili s podobnim delovanjem (to so ciklosporin in kortikosteroidi).
BEFORE YOU TAKE MYCOPHENOLATE MOFETIL TEVA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO MOFETILMIKOFENOLAT TEVA
Do not take Mycophenolate mofetil Teva
Ne jemljite zdravila Mofetilmikofenolat Teva:
- if you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
- če ste alergični na (preobčutljivi za) mofetilmikofenolat, mikofenolno kislino ali katerokoli sestavino
other ingredients of Mycophenolate mofetil Teva.
zdravila Mofetilmikofenolat Teva;
Take special care with Mycophenolate mofetil Teva You should inform your doctor immediately:
Svojega zdravnika morate nemudoma obvestiti:
- if you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising and/ or
- če opazite znake okužbe (npr. zvišana telesna temperatura, vneto grlo), nepričakovane podplutbe
bleeding
in/ ali krvavitve;
Mycophenolate mofetil Teva reduces your body’ s defence mechanism.
- če imate ali ste kdaj imeli težave s prebavili, npr. rano na želodcu.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Ker zdravilo Mofetilmikofenolat Teva zmanjša obrambno sposobnost vašega organizma, obstaja zvečana možnost nastanka kožnega raka, zato se je treba izogibati sončni svetlobi in UV- žarkom z uporabo zaščitnih oblačil in sončne kreme z visokim zaščitnim faktorjem.
If you answer yes to any of the following questions talk to your doctor before you start to take Mycophenolate mofetil Teva:
Jemanje drugih zdravil:
40
40 Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
- Are you taking any medicines containing: azathioprine or other immunosuppressive agents (which
- Ali morda jemljete zdravila, ki vsebujejo azatioprin ali druga imunosupresivna zdravila (bolniki jih včasih
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal kidney failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
prejmejo po presaditveni operaciji), holestiramin (uporabljajo ga za zdravljenje bolnikov z visokim holesterolom), rifampicin (antibiotic), antacid, fosfatne vezalce (uporabljajo jih za zmanjšanje absorpcije fosfatov pri bolnikih s kronično ledvično odpovedjo) ali druga zdravila (vključno s tistimi, ki ste jih dobili brez recepta), za katera vaš zdravnik ne ve?
indicated for you
Jemanje zdravila Mofetilmikofenolat Teva skupaj s hrano in pijačo:
Taking Mycophenolate mofetil Teva with food and drink Taking food and drink has no influence on your treatment with Mycophenolate mofetil Teva.
Jemanje skupaj s hrano in pijačo nima vpliva na zdravljenje z zdravilom Mofetilmikofenolat Teva.
Pregnancy and breast-feeding Do not take Mycophenolate mofetil Teva if you are breast-feeding.
Ne jemljite zdravila Mofetilmikofenolat Teva, če dojite.
Your doctor should advise you about using contraception before taking Mycophenolate mofetil Teva, whilst taking Mycophenolate mofetil Teva, and for 6 weeks after you have stopped taking Mycophenolate mofetil Teva.
Vaš zdravnik vam bo svetoval glede uporabe kontracepcijske zaščite pred in med jemanjem zdravila Mofetilmikofenolat Teva in šest tednov po prekinitvi jemanja zdravila Mofetilmikofenolat Teva.
Mycophenolate mofetil Teva may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Zdravilo Mofetilmikofenolat Teva lahko povzroči spontani splav ali poškoduje vašega (še) nerojenega otroka, vključno z nepravilno razvitostjo ušes.
Driving and using machines Mycophenolate mofetil Teva has not been shown to impair your ability to drive or operate machines.
Za zdravilo Mofetilmikofenolat Teva ni bilo pokazano, da vpliva na sposobnost za upravljanje vozil ali strojev.
HOW TO TAKE MYCOPHENOLATE MOFETIL TEVA
KAKO JEMATI ZDRAVILO MOFETILMIKOFENOLAT TEVA
Your doctor will decide the most appropriate dose based on body surface area (height and weight).
Zdravnik bo določil najbolj ustrezen odmerek glede na telesno 2 površino (višina in telesna masa).
The recommended dose is 600 mg/ m2 taken twice a day.
Priporočeni odmerek je 600 mg/ m dvakrat na dan.
No data are available to recommend the use of Mycophenolate mofetil Teva in children and adolescents who have received a heart transplant.
Podatki o priporočenem odmerjanju zdravila Mofetilmikofenolat Teva pri otrocih in mladostnikih, ki so prejeli srčni presadek, niso na voljo.