natgillin/translations-raw huggingface dataset:
Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Myfenax initiated as soon after this as it can be tolerated.
Odrasli: prve 4 dni po presaditvi jeter je treba dajati mofetilmikofenolat intravensko, takoj ko je bolnik sposoben požirati, pa nadaljujemo s peroralno obliko zdravila Myfenax.
Children and adolescents: no data are available for paediatric hepatic transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Otroci in mladostniki: za otroke in mladostnike z jetrnim presadkom podatki niso znani, zato uporaba zdravila Myfenax v tej starostni skupini ni priporočljiva, dokler ne bodo na voljo zadostni podatki.
Use in elderly (≥ 65 years)
Uporaba pri starejših bolnikih (stari 65 let ali več)
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Bolnikom s hudo kronično ledvično okvaro (glomerulna filtracija < 25 ml• min- 1• 1, 73 m- 2) izven obdobja neposredno po presaditvi ne dajemo odmerkov, večjih od 1 g dvakrat na dan.
Hypersensitivity reactions to the active substance, to mycophenolic acid or any of the excipients..
Preobčutljivost za zdravilno učinkovino, mikofenolno kislino ali katerokoli pomožno snov.
Myfenax is contraindicated in women who are breast-feeding (see section 4.6).
Zdravilo Myfenax je kontraindicirano pri ženskah, ki dojijo (glejte poglavje 4. 6).
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Myfenax, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Bolniki, ki prejemajo kombinacije imunosupresivnih zdravil, vključno z zdravilom Myfenax, so izpostavljeni povečanem tveganju nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4. 8).
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Zdi se, da je tveganje bolj odvisno od intenzivnosti in trajanja imunosupresije kot od
As general advice to minimise the risk for skin cancer, exposure to sunlight and ultra violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Splošen nasvet za zmanjšanje tveganja nastanka kožnega raka je, da se bolniki ne izpostavljajo soncu in UV- svetlobi brez uporabe zaščitne obleke in sončne kreme z visokim zaščitnim faktorjem.
Patients receiving Myfenax 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 Myfenax, naročimo, da morajo takoj poročati o kakršnemkoli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih depresije kostnega mozga.
3 Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Bolniki, ki se zdravijo z imunosupresivi, vključno z zdravilom Myfenax, imajo povečano tveganje za oportunistične okužbe (bakterijske, glivične, virusne in protozojske), smrtne okužbe in sepso (glejte poglavje 4. 8).
If neutropenia develops (absolute neutrophil count < 1.3 x 103/μ l) it may be appropriate to interrupt or discontinue Myfenax.
Če se pojavi nevtropenija (absolutno število nevtrofilcev < 1, 3 x 103/ µl), moramo odmerke zdravila Myfenax zmanjšati ali zdravljenje prekiniti.
Patients should be advised that during treatment with Myfenax, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Bolnike, ki prejemajo zdravilo Myfenax, moramo opozoriti, da so lahko cepiva manj učinkovita, uporabi živih cepiv pa se morajo izogibati (glejte poglavje 4. 5).
Because mycophenolate has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Myfenax should be administered with caution in patients with active serious digestive system disease.
Bolnikom s hujšimi boleznimi prebavil v aktivnih fazah zato dajemo zdravilo Myfenax zelo previdno in pod skrbnim zdravniškim nadzorom.
Myfenax is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Zdravilo Myfenax je zaviralec inozin- monofosfat- dehidrogenaze (IMPDH).
On theoretical grounds, 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.
Na podlagi teoretičnih osnov zdravila Myfenax ne dajemo bolnikom z redkim dednim pomanjkanjem hipoksantin- gvanin- fosforibozil - transferaze (HGPRT), kot sta Lesch- Nyhlanov in Kelley- Seegmillerjev sindrom.
It is recommended that Myfenax should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Ne priporočamo sočasnega dajanja zdravila Myfenax in azatioprina, ker kombiniranega jemanja teh zdravil niso proučevali.
In view of the significant reduction in the AUC (area under the curve) of MPA by cholestyramine, caution should be used in the concomitant administration of Myfenax with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Myfenax.
Ker holestiramin značilno zmanjša AUC (površino pod krivuljo) mikofenolne kisline, dajemo zdravilo Myfenax previdno bolnikom, ki sočasno jemljejo druga zdravila, ki vplivajo na enterohepatični obtok zaradi možnosti zmanjšanja učinkovitosti zdravila Myfenax.
The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
4 Spremembe v farmakokinetiki mikofenolglukuronida (ki ga je za 8% več) so bile minimalne in niso klinično pomembne.
Cholestyramine: following single dose administration 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g three times a day (TID )of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
Holestiramin: če dajemo holestiramin 4 dni v odmerku 4 g trikrat na dan, ta zmanjša AUC mikofenolne kisline po enkratnem peroralnem vnosu 1, 5 g mofetilmikofenolata za približno 40% (glejte poglavje 4. 4 in poglavje 5. 2).
4 Medicinal products that interfere with enterohepatic circulation: caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of Myfenax.
Zdravila, ki vplivajo na enterohepatični obtok: pri uporabi zdravil, ki vplivajo na enterohepatični obtok, je potrebna previdnost, saj lahko zmanjšajo učinkovitost mofetilmikofenolata.
Ganciclovir; based on the results of a single dose administration study of recommended doses of oral mycophenolate and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate (see section 4.2) and ganciclovir, it is anticipated that co- administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Ganciklovir: na podlagi rezultatov študije enkratnega odmerjanja priporočenih odmerkov peroralne oblike mofetilmikofenolata in intravenske oblike ganciklovirja in znanih učinkov ledvične okvare na farmakokinetiko mofetilmikofenolata (glejte poglavje 4. 2) in ganciklovirja, je pričakovati, da bo sočasno dajanje obeh učinkovin, ki tekmujeta v mehanizmih renalne tubularne sekrecije, povzročilo zvišanje koncentracij mikofenolglukuronida in ganciklovirja.
In patients with renal impairment in which Myfenax and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Bolnike z ledvično okvaro, ki sočasno dobivajo zdravilo mofetilmikofenolat in ganciklovir oziroma njegova predzdravila, npr. valganciklovir, je treba skrbno nadzorovati in proučiti odmerjanje ganciklovirja.
Rifampicin: in patients not also taking ciclosporin, concomitant administration of Mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Rifampicin: pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno mofetilmikofenolata in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0- 12h) za 18 d0 70%.
Sirolimus: in renal transplant patients, concomitant administration of mycphenolate mofetil and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of Myfenax (see also section 4.4).
Sirolimus: pri bolnikih z ledvičnim presadkom je sočasno dajanje mofetilmikofenolata in ciklosporina A povzročilo manjšo izpostavljenost mikofenolni kislini za 30 do 50% v primerjavi z bolniki, ki so prejeli kombinacijo sirolimusa in podobnih odmerkov zdravila Myfenax (glejte tudi poglavje 4. 4).
Sevelamer: decrease in MPA Cmax and AUC by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Sevelamer: pri sočasnem dajanju mofetilmikofenolata in sevelamerja so opazili zmanjšanje cmax mikofenolne kisline za 30% in AUC0- 12h mikofenolne kisline za 25%, kliničnih posledic (zavrnitve presadka) pa ni bilo.
Norfloxacin and metronidazole: in healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin and metronidazole separately.
Kombinacija
However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of mycophenolate mofetil.
5 norfloksacina in metronidazola pa zmanjša izpostavljenost mikofenolni kislini za približno 30% po enkratnem odmerku mofetilmikofenolata.
Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
Takrolimus: pri bolnikih z jetrnim presadkom, pri katerih so uvedli mofetilmikofenolat in takrolimus, sprememba AUC in cmax mikofenolne kisline, aktivnega presnovka mofetilmikofenolata, zaradi sočasnega dajanja takrolimusa ni bila pomembna.
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice [BID] a day, morning and evening]) were administered to patients taking tacrolimus (see also section 4.4).
(glejte tudi poglavje 4. 4).
5 Live vaccines: live vaccines should not be given to patients with an impaired immune response The antibody response to other vaccines may be diminished (see also section 4.4).
Tudi odziv protiteles na druga cepiva je lahko zmanjšan (glejte tudi poglavje 4. 4).
It is recommended that Myfenax therapy should not be initiated until a negative pregnancy test has been obtained.
Pred začetkom zdravljenja z zdravilom Myfenax je treba izključiti nosečnost.
Effective contraception must be used before beginning Myfenax therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
Pred in med zdravljenjem ter najmanj šest tednov po končani terapiji z zdravilom Myfenax, morajo bolnice uporabljati učinkovito kontracepcijo (glejte poglavje 4. 5).
The use of Myfenax is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
Uporaba zdravila Myfenax med nosečnostjo ni priporočljiva, rezervirana je za primere, ko ustreznega nadomestnega zdravljenja ni na voljo.
Myfenax should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
Zdravilo Myfenax dajemo nosečnicam le v primeru, kadar pričakovana korist za mater prevlada nad tveganjem za plod.
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myfenax is contraindicated in breast-feeding mothers (see section 4.3).
Zaradi možnih resnih škodljivih vplivov mofetilmikofenolata na dojenčke, je zdravilo Myfenax pri doječih materah kontraindicirano (glejte poglavje 4. 3).
Malignancies:
6 Malignosti:
6 Children and adolescents:
Otroci in mladostniki:
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.
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
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
7 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
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.
- Tachycardia
tahikardija
Vomiting, abdominal pain, diarrhoea, nausea Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
krvavitev v prebavilih, peritonitis, ileus, kolitis, ulkus na želodcu, ulkus na dvanajstniku, gastritis, ezofagitis, stomatitis, zaprtje, dispepsija, flatulenca, kolcanje
- Renal impairment
ledvična okvara
Skin and
hipertrofija kože, izpuščaj, akne, alopecija
subcutaneous
zelo pogosti
Skin hypertrophy, rash, acne, alopecia
acidoza, hiperkaliemija, hipokaliemija, hiperglikemija,
tissue disorders Musculoskeletal and connective tissue disorders
hipomagnezemija, hipokalciemija, hiperholesterolemija, hiperlipidemija, hipofosfatemija, hiperurikemija, protin, anoreksija
- Arthralgia
pogosti
Metabolism and nutrition disorders
pljučnica, gripa, okužba respiratornega trakta, respiratorna
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
pogosti
Infections and infestations
kožni rak, benigna neoplazma kože
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
pogosti
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hipotenzija, hipertenzija, vazodilatacija
- Skin cancer, benign neoplasm of skin
edem, pireksija, mrzlica, bolečina, občutek neugodja, astenija
Vascular disorders General disorders and administration site conditions
Bolezni jeter, žolčnika in
- Hypotension, hypertension, vasodilatation - Oedema, pyrexia, chills, pain, malaise, asthenia
hepatitis, zlatenica, hiperbilirubinemija
Hepatobiliary disorders Psychiatric disorders
Psihiatrične motnje
501 (2 g mycophenolate daily), 289 (3 g mycophenolate daily) and 277 (2 g intravenous / 3 g oral mycophenolate daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
V III. fazi študij preprečevanja zavrnitve ledvičnega, srčnega in jetrnega presadka so vključili 501 (2 g mikofenolata na dan), 289 (3 g mofetilmikofenolata na dan) in 277 (2 g i. v. / 3 g peroralne oblike mofetilmikofenolata na dan) bolnikov.
Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
V oklepajih je navedena njihova 9 pogostnost, če je znana.
Gastrointestinal: colitis including cytomegalovirus colitis, (common), pancreatitis, (common) and intestinal villous atrophy.
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
Poročali so tudi o agranulocitozi (občasni) in nevtropeniji, zato je priporočljivo bolnike, ki jemljejo zdravilo Myfenax, redno spremljati (glejte poglavje 4. 4).
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.
4.9 Overdose Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
O primerih prevelikega odmerjanja mofetilmikofenolata so poročali v kliničnih preskušanjih in med trženjem zdravila.
If neutropenia develops, dosing with Myfenax should be interrupted or the dose reduced (see section 4.4).
Če se pojavi nevtropenija, je treba odmerjanje zdravila Myfenax prekiniti ali odmerek zmanjšati (glejte poglavje 4. 4).
As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of mycophenolate is correlated with MPA concentration.
Kot je razvidno iz supresije akutne zavrnitvene reakcije po transplantaciji ledvice, je imunosupresivno delovanje mofetilmikofenolata povezano s koncentracijo
However, at high MPAG plasma concentrations (> 100μ g/ ml), small amounts of MPAG 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 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).
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).
In a single dose study (6 subjects/ group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/ skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija < 25 ml• mim- 1• 1, 73 m- 2) srednji AUC mikofenolne kisline v plazmi za 28 do 75% večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
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.
Children and adolescents:
11 Otroci in mladostniki:
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.
Ti odmerki so dali podobne vrednosti AUC 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 highest dose tested in the animal carcinogenicity studies resulted in approximately 2-3 times the systemic exposure (AUC or Cmax) observed in renal transplant patients as the recommended clinical dose of 2 g/ day and 1.3-2 times the systemic exposure (AUC or Cmax) 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 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 systemic exposure at these levels are approximately equivalent to or less than 0.5 times the clinical exposure at the recommended clinical dose of 2 g/ day for renal transplant patients and approximately 0.3 times the clinical exposure at the recommended clinical dose of 3 g/ day for cardiac transplant patients.
12 izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan pri bolnikih z ledvičnim presadkom in približno 0, 3- krat večja kot klinična izpostavljenost pri priporočenem kliničnem odmerku 3 g na dan pri bolnikih s srčnim presadkom.
Pregelatinised starch (maize) Povidone K-30 Croscarmellose sodium Magnesium stearate 12 Capsule shell:
Kapsula vsebuje: predgeliran koruzni škrob povidon K- 30 premrežen natrijev karmelozat magnezijev stearat
Cap:
Ovojnica kapsule:
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
Pokrovček: indigotin (E132) titanov dioksid (E171) želatina Telo: rdeči železov oksid (E172) rumeni železov oksid (E172). titanov dioksid (E171) želatina Črnilo vsebuje: šelak, črni železov oksid (E172), propilenglikol in kalijev hidroksid.
Transparent PVC/ PVdC – aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Prozorni PVC/ PVdC – aluminijasti pretisni omoti v pakiranjih po 100 in 300 kapsul v škatli.