natgillin/translations-raw huggingface dataset:
Uncommon (affects 1 to 10 users in 1,000)
Občasni (prizadanejo 1 do 10 uporabnikov od 1. 000)
- abnormal blood tests (decreased blood cells [pancytopenia]); decreased blood platelets
- nenormalne krvne preiskave (zmanjšano število krvničk [pancitopenija]), zmanjšano število
(thrombocytopenia); increases in a certain type of white blood cells called eosinophils; decreased albumin in the blood (hypoalbuminaemia)
trombocitov (trombocitopenija), povečano število nekaterih vrst belih krvničk, imenovanih eozinofilci, zmanjšana vrednost albumina v krvi (hipoalbuminemija)
- allergic attack (anaphylactic reaction / anaphylactoid shock); hypersensitivity
- alergijski napad (alergijska reakcija/ anafilaktoidni šok), preobčutljivost
- increased sweating
- povečano potenje
- decreased sodium in the blood (hyponatraemia); increased potassium in the blood
- zmanjšana vrednost natrija v krvi (hiponatriemija), povečana vrednost kalija v krvi
(hyperkalaemia); decreased phosphates in the blood (hypophosphataemia); anorexia (eating disorder)
(hiperkaliemija), zmanjšana vrednost fosfatov v krvi (hipofosfatemija), anoreksija (motnja prehranjevanja)
- insomnia (difficulty in sleeping); anxiety; confusion
- nespečnost (težave s spanjem), tesnoba, zmedenost
- feeling lethargic (somnolence); trembling; dizziness; disturbed taste
- utrujenost (zaspanost), tresenje, omotica, moten okus
- increased heart rate; stronger heartbeat; irregular heartbeat
- povečan srčni utrip, močnejši srčni utrip, nepravilni srčni utrip
- high or low blood pressure; skin flushing
- visok ali nizek krvni tlak, zardevanje
- shortness of breath
- kratka sapa
- indigestion; constipation
- prebavne motnje, zaprtost
- liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the
- jetrna odpoved, povečana vrednost jetrnih encimov (gama- glutamiltransferaze), zlatenica
skin or whites of the eyes caused by liver or blood problems); reduced bile reaching the intestine (cholestasis); enlarged liver; liver inflammation
(porumenelost kože ali beločnic, ki jo povzročijo težave z jetri ali krvjo), zmanjšano izločanje žolča v črevo (holestaza), povečana jetra, vnetje jeter
- itchy rash (urticaria); itching; skin flushing (erythema)
- srbeč izpuščaj (koprivnica), srbenje, rdečica (eritem)
- abnormal kidney function tests (increased blood creatinine; increased urea in the blood);
- nenormalne preiskave ledvičnega delovanja (povečana vrednost kreatinina v krvi, povečana
aggravated kidney failure
vrednost sečnine v krvi), poslabšanje ledvične odpovedi
- increase in an enzyme called lactate dehydrogenase
- povečana vrednost encima laktat- dehidrogenaze
- clotting in vein at injection-site; inflammation at injection-site; pain at injection-site; collection of
- strjevanje krvi v veni na mestu injiciranja, vnetje na mestu injiciranja, bolečina na mestu
fluid in your body
injiciranja, kopičenje tekočine v telesu
Rare (affects 1 to 10 users in 10,000)
39 Redki (prizadanejo 1 do 10 uporabnikov od 10. 000)
- anaemia due to breakdown of red blood cells (haemolytic anaemia), breakdown of red blood cells
- anemija zaradi razpadanja rdečih krvničk (hemolitična anemija), razpadanje rdečih krvničk
(haemolysis)
(hemoliza)
Not known (frequency cannot be estimated from the available data)
Neznano (iz razpoložljivih podatkov ni mogoče oceniti pogostosti)
- damage to liver cells including death
- poškodba jetrnih celic, vključno s smrtnim izidom
- kidney problems; acute kidney failure
- težave z ledvicami, akutna ledvična odpoved
The following reactions have been reported more often in paediatric patients than in adult patients:
O naslednjih reakcijah so pogosteje poročali pri otrocih kot pri odraslih bolnikih:
- decreased blood platelets (thrombocytopenia)
- zmanjšano število trombocitov (trombocitopenija)
- increased heart rate (tachycardia)
- povečan srčni utrip (tahikardija)
- high or low blood pressure
- akutna ledvična odpoved, povečana vrednost sečnine v krvi
- increased bile pigment in the blood (hyperbilirubinaemia); enlarged liver
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE MYCAMINE
SHRANJEVANJE ZDRAVILA MYCAMINE
The reconstituted concentrate and the diluted infusion solution should be used immediately.
Koncentrat in razredčeno raztopino za infundiranje je treba uporabiti takoj.
In order to protect the infusion bottle / bag containing the diluted infusion solution from light it should be inserted into a closable opaque bag.
Za zaščito pred svetlobo je treba infuzijsko steklenico/ vrečko, ki vsebuje razredčeno raztopino za infundiranje, vložiti v neprosojno vrečko, ki jo je mogoče zapreti.
Reconstituted Mycamine should be used immediately because it does not contain any preservatives to prevent bacterial contamination.
Pripravljeno raztopino zdravila Mycamine je treba uporabiti takoj, saj ne vsebuje konservansov, ki preprečujejo onesnaženje z bakterijami.
Only a trained health care professional who has read the complete directions properly can prepare this medicine for use.
To zdravilo lahko za uporabo pripravi samo usposobljen zdravstveni strokovnjak, ki je ustrezno prebral celotna navodila za uporabo.
What Mycamine contains
Kaj vsebuje zdravilo Mycamine
- The active substance is micafungin sodium.
- Zdravilna učinkovina je natrijev mikafunginat.
- The other ingredients are lactose monohydrate, citric acid anhydrous and sodium hydroxide.
- Ostale sestavine so laktoza monohidrat, brezvodna citronska kislina in natrijev hidroksid.
40 Mycamine 50 mg or 100 mg powder for solution for infusion is a white compact freeze-dried powder.
40 Zdravilo Mycamine 50 mg ali 100 mg prašek za raztopino za infundiranje je bel kompakten prašek, pridobljen z zamrzovalnim sušenjem.
Marketing Authorisation Holder Astellas Pharma Europe B.V.
Imetnik dovoljenja za promet z zdravilom Astellas Pharma Europe B. V.
Manufacturer Astellas Ireland Co., Ltd.
Izdelovalec Astellas Ireland Co., Ltd.
Astellas Pharmaceuticals AEBE 10ο χλµ Εθνικής Οδού, Αθηνών-Λαµίας GR-14451 Μεταµόρφωση Αττικής, Τηλ.: +30 210 2812640
41 Ελλάδα Astellas Pharmaceuticals AEBE 10ο χλµ Εθνικής Οδού, Αθηνών- Λαµίας GR- 14451 Μεταµόρφωsη Αττικής, Τηλ.: +30 210 2812640
Κύπρος Astellas Pharmaceuticals AEBE 10ο χλµ Εθνικής Οδού, Αθηνών-Λαµίας GR-14451 Μεταµόρφωση Αττικής, Τηλ.: +30 210 2812640
Κύπρος Astellas Pharmaceuticals AEBE 10ο χλµ Εθνικής Οδού, Αθηνών- Λαµίας GR- 14451 Μεταµόρφωση Αττικής, Ελλάδα Τηλ.: +30 210 2812640
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
43 The following information is intended for medical or healthcare professionals only:
43 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Standard infusion (added up to 100 ml) Final concentration
Volumen (koncentracija) koncentrata
1 x 100
Standardna infuzija (dodano do 100 ml) Končna koncentracija
Ref.
London, 20. 03. 2007 Ref. dok.
On 16 November 2006, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mycograb 2 mg/ ml powder for solution for injection intended for the treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B.
Dne 16. novembra 2006 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Mycograb 2 mg/ ml v obliki praška za raztopino za injiciranje, namenjenega za uporabo pri zdravljenju invazivne kandidiaze pri odraslih bolnikih v kombinaciji z amfotericinom B ali lipidno formulacijo amfotericina B.
The applicant requested a re- examination of the opinion.
Vlagatelj je prosil za ponoven pregled podanega mnenja.
After having considered the grounds for this request, the CHMP re- examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2007.
Ko je CHMP pretehtal razloge za to prošnjo, je ponovno pregledal podano mnenje in dne 20. marca 2007 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
Invasive candidiasis is a life-threatening disease..
Invazivna kandidiaza je življenjsko nevarna bolezen.
Because the number of patients with invasive fungal infections is low, Mycograb was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 5 December 2001.
Ker je število bolnikov z invazivnimi glivičnimi okužbami majhno, je bilo zdravilo Mycograb dne 5. decembra 2001 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja proti redkim boleznim).
By attaching to hsp90, efungumab blocks the protein’ s normal activities.
Ko se efungumab veže na hsp90, s tem zavre normalno delovanje beljakovine.
Efungumab is produced by a method known as ‘ recombinant DNA technology’.
Učinkovino efungumab se izdeluje z metodo, ki se imenuje „ tehnologija rekombinantne DNA “.
The main study of the medicine’ s effects involved 139 adults with invasive candidiasis.
Glavna raziskava učinkov zdravila je vključevala 139 odraslih bolnikov z invazivno kandidiazo.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V raziskavi so primerjali učinke zdravila Mycograb z učinki placeba (zdravila brez zdravilne 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged učinkovine), ki so ju pet dni dajali skupaj z amfotericinom B.
The medicine is associated with ‘ cytokine release syndrome’, a condition that can cause nausea, vomiting, pain and also hypertension (high blood pressure), but the reason for this is not clear.
Zdravilo se povezuje s „ sindromom sproščanja citokinov “, katerega vzroki niso jasni, povzroča pa bruhanje, bolečine in hipertenzijo (visok krvni tlak).
In March 2007, following the re-examination, the CHMP removed their concern regarding the cytokine release syndrome and hypertension, as these would be manageable in clinical practice.
V marcu leta 2007 je CHMP po ponovnem pregledu umaknil svoje zadržke glede sindroma sproščanja citokinov in hipertenzije, ker je le- te v klinični praksi mogoče obvladovati.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mycograb?
Kakšne so posledice zavrnitve vloge za bolnike, ki sodelujejo v kliničnih preizkušanjih/ programih sočutne uporabe zdravila Mycograb?
Mycophenolate mofetil Teva is a ‘ generic medicine’.
Mycophenolate mofetil Teva je „ generično zdravilo “.
This means that Mycophenolate mofetil Teva is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called CellCept.
To pomeni, da je podobno „ referenčnemu zdravilu “, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu CellCept.
Mycophenolate mofetil Teva treatment should be initiated and maintained by a qualified transplant specialist.
Zdravljenje z zdravilom Mycophenolate mofetil Teva mora uvesti in voditi specialist za presaditve.
The way that Mycophenolate mofetil Teva should be given and the dose depend on the type of organ transplant and the patient ’ s age and size.
Način uporabe zdravila Mycophenolate mofetil Teva in njegovo odmerjanje sta odvisna od vrste presajenega organa ter bolnikove starosti in velikosti.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Priporočeni odmerek za odrasle po presaditvi ledvice je 1, 0 g dvakrat na dan, pri čemer se z jemanjem zdravila začne v 72 urah po presaditvi.
In children aged between two and 18 years, the dose of Mycophenolate mofetil Teva is calculated depending on height and weight.
Pri otrocih, starih od 2 do 18 let, se odmerek zdravila Mycophenolate mofetil Teva izračuna na osnovi telesne višine in mase.
For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Priporočeni odmerek za odrasle po presaditvi srca je 1, 5 g dvakrat na dan, pri čemer se z jemanjem zdravila začne v petih dneh po presaditvi.
For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Mycophenolate mofetil Teva twice a day as soon as it can be tolerated.
Pri odraslih bolnikih s presajenimi jetri se mofetilmikofenolat prve štiri dni po presaditvi daje kot infuzija (kapalna infuzija v veno), ko je bolnik sposoben požirati pa preide na jemanje zdravila Mycophenolate mofetil Teva dvakrat na dan.
Mycophenolate mofetil Teva is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Za otroke po presaditvi srca ali jeter jemanje zdravila Mycophenolate mofetil Teva ni priporočljivo zaradi pomanjkanja informacij o učinkih zdravila v tej starostni skupini.
The dose may need to be adjusted in patients with liver or kidney disease.
Pri bolnikih z obolenjem jeter ali ledvic bo odmerek morda treba prilagoditi.
In the body, it is converted into mycophenolic acid, which blocks an 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V telesu se pretvori v mikofenolno kislino, ki blokira encim, imenovan „ inozin - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non-commercial or commercial purposes, provided the EMEA is acknowledged enzyme called ‘ inosine monophosphate dehydrogenase’.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non- commercial or commercial purposes, provided the EMEA is acknowledged monofosfat- dehidrogenaza “.
This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Ta encim je pomemben za tvorbo DNA v celicah, zlasti v limfocitih (vrsta belih krvnih celic, ki sodelujejo pri zavračanju presajenih organov).
By preventing the production of new DNA, Mycophenolate mofetil Teva reduces the rate at which the lymphocytes multiply.
Zdravilo Mycophenolate mofetil Teva s preprečevanjem tvorbe nove DNA zmanjša hitrost razmnoževanja limfocitov.
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Zaradi tega so manj učinkoviti pri prepoznavanju in napadanju presajenega organa, kar zmanjšuje tveganje, da bo organ zavrnjen.
Because Mycophenolate mofetil Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).
Ker je Mycophenolate mofetil Teva generično zdravilo, so bile študije omejene na teste, s katerimi se lahko dokaže, da je bioekvivalentno referenčnemu zdravilu (zdravili dosegata enake ravni zdravilne učinkovine v telesu).
What are the benefit and risk of Mycophenolate mofetil Teva?
Kakšne so koristi in tveganja, povezana z zdravilom Mycophenolate mofetil Teva?
Because Mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Glede na to, da je Mycophenolate mofetil Teva generično zdravilo in je bioekvivalentno referenčnemu zdravilu, ima enake koristi in tveganja kot referenčno zdravilo.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Mycophenolate mofetil Teva has been shown to have comparable quality and to be bioequivalent to Cellcept.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Mycophenolate mofetil Teva primerljivo raven kakovosti kot zdravilo CelleCept ter da mu je bioekvivalentno.
Therefore, the CHMP’ s view was that, as for CellCept, the benefit outweighs the identified risk.
Zaradi tega je CHMP menil, da so koristi zdravila Mycophenolate mofetil Teva, tako kot pri zdravilu CellCept, večje od znanih tveganj.
Other information about Mycophenolate mofetil Teva:
Druge informacije o zdravilu Mycophenolate mofetil Teva:
The European Commission granted a marketing authorisation valid throughout the EU for Mycophenolate mofetil Teva to Teva Pharma B. V. on 21 February 2008.
Evropska komisija je dovoljenje za promet z zdravilom Mycophenolate mofetil Teva, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma B. V. dne 21. februarja 2008.
The full EPAR for Mycophenolate mofetil Teva can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mycophenolate mofetil Teva je na voljo tukaj.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
Celotno Evropsko javno poročilo o oceni zdravila za referenčno zdravilo je na voljo na spletni strani EMEA.
Packaging
100 kapsul
Package size
trda kapsula
Capsule, hard Capsule, hard Film-coated tablet Film-coated tablet
pretisni omot (PVC/ PVDC/ alu)
Oral use Oral use Oral use Oral use
Mycophenolate mofetil Teva
blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu)
pretisni omot (PVC/ PVDC/ alu)
100 capsules 300 capsules 50 tablets 150 tablets
150 tablet
Excipient For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
PHARMACEUTICAL FORM
FARMACEVTSKA OB LIKA
Hard capsule (capsule) The capsule body is caramel opaque, printed with ‘ 250’ axially in black ink The capsule cap is light blue opaque printed ‘ M’ axially in black ink.
Telo kapsule je karamelne barve s črnim napisom “ 250” v smeri osi kapsule Glava kapsule je svetlo modra s črnim napisom “ M ” v smeri osi kapsule.
Adults: oral Mycophenolate mofetil Teva should be initiated within 72 hours following transplantation.
Zdravilo Mofetilmikofenolat Teva damo uvodoma peroralno v 72 urah po presaditvi.
The recommended dose in renal transplant patients is 1.0 g administered twice daily (2 g daily dose).
Priporočeni odmerek pri bolnikih z ledvičnim presadkom je 1, 0 g dvakrat na dan (dnevni odmerek 2 g).
Children and adolescents: the recommended dose of mycophenolate mofetil is 600 mg/ m2 administered orally twice daily (up to a maximum of 2 g daily). Mycophenolate mofetil Teva capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Otroci in mladostniki: priporočeni odmerek mofetilmikofenolata je 600 mg/ m2, vzetih peroralno dvakrat na dan (do največ 2 g na dan).
Patients with a body surface are of 1.25 to 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Kapsule zdravila Mofetilmikofenolat Teva lahko predpišemo samo bolnikom, katerih
Patients with a body surface area greater than 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
2
Children (< 2 years): there are limited safety and efficacy data in children below the age of 2 years.
2
These are insufficient to make dose recommendations and therefore use in this age group is not recommended.
Bolnikom s 2 telesno površino nad 1, 5 m predpišemo kapsule zdravila Mofetilmikofenolat Teva v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
Use in cardiac transplant:
Otroci, mlajši od 2 let: o varnosti in učinkovitosti pri otrocih, mlajših od dveh let, je na voljo premalo podatkov.
2 Adults: oral Mycophenolate mofetil Teva should be initiated within 5 days following transplantation.
Priporočeni
The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
2 odmerek pri bolnikih s srčnim presadkom je 1, 5 g dvakrat na dan (dnevni odmerek 3 g).
Children and adolescents: no data are available for paediatric cardiac transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Otroci in mladostniki: za otroke s srčnim presadkom podatki niso znani, zato uporaba zdravila Mofetilmikofenolat Teva v tej starostni skupini ni priporočljiva, dokler ne bodo na voljo zadostni podatki.
Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Mycophenolate mofetil Teva 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 Mofetilmikofenolat Teva.
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 Mofetilmikofenolat Teva 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)
The recommended dose of 1.0 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Priporočeni odmerek za starejše bolnike je 1, 0 g dvakrat na dan za bolnike z ledvičnim presadkom in 1, 5 g dvakrat na dan za bolnike s srčnim ali jetrnim presadkom.
Use in renal impairment
Uporaba pri bolnikih z ledvično okvaro
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.
Use in severe hepatic impairment
Uporaba pri bolnikih z jetrno okvaro
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dose reduction or interruption of Mycophenolate mofetil Teva is not required.
Zavrnitev ledvičnega presadka ne spremeni farmakokinetike mikofenolne kisline, zmanjšanje odmerka ali prekinitev zdravljenja z zdravilom Mofetilmikofenolat Teva ni potrebna.
Hypersensitivity to the active substance, to mycophenolic acid or any of the excipients.
Preobčutljivost za zdravilno učinkovino, mikofenolno kislino ali katerokoli pomožno snov.
Mycophenolate mofetil Teva is contraindicated in women who are breast-feeding (see section 4.6).
Zdravilo Mofetilmikofenolat Teva je kontraindicirano pri ženskah, ki dojijo (glejte poglavje 4. 6).