natgillin/translations-raw huggingface dataset:
5 mL of the reconstituted suspension contains 1 g of mycophenolate mofetil.
5 ml rekonstituirane suspenzije sadrži 1 g mofetilmikofenolata.
The shelf-life of the reconstituted suspension is 2 months.
Rok valjanosti pripremljene suspenzije je 2 mjeseca.
Oral administration.
Peroralna primjena.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA CellCept 500 mg prašak za koncentrat za otopinu za infuziju mofetilmikofenolat
In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus.
Nasuprot tome, kod bolesnika s presađenom jetrom koji su uzimali takrolimus, došlo je do povećanja AUC-a takrolimusa za otprilike 20% pri uzimanju višestrukih doza lijeka CellCept (1,5 g dvaput dnevno).
Do not use solvent-containing wipes for cleaning.
Nemojte ga čistiti maramicama koje sadrže otapala.
Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including CellCept.
U bolesnika liječenih imunosupresivima, uključujući CellCept, prijavljeni su slučajevi nefropatije povezane s BK virusom, kao i slučajevi progresivne multifokalne leukoencefalopatije (PML) povezane s JC virusom.
Hyperlipidemia
Hiperlipidemija
Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal, hepatic and cardiac transplant patients.
Zbog opaženih velikih razlika u učestalosti određenih nuspojava lijeka kod primjene u različitim indikacijama, učestalost je navedena zasebno za bolesnike s bubrežnim, jetrenim odnosno srčanim presatkom.
Note: 991 (2 g / 3 g CellCept daily), 289 (3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Napomena: U ispitivanjima faze III 991 bolesnik primao je CellCept u dozi od 2 g / 3 g na dan za sprječavanje odbacivanja bubrežnog presatka, 289 bolesnika primalo je CellCept u dozi od 3 g na dan za sprječavanje odbacivanja srčanog presatka, a 277 bolesnika primalo je CellCept u dozi od 2 g i.v. / 3 g peroralno na dan za sprječavanje odbacivanja jetrenog presatka.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacture(s) responsible for batch release CellCept 500 mg powder for concentrate for solution for infusion CellCept 1 g/5 ml powder for oral suspension: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet - CellCept 500 mg prašak za koncentrat za otopinu za infuziju - CellCept 1 g/5 ml prašak za pripremu oralne suspenzije:
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.
Pri peroralnim dozama do 20 mg/kg/dan, mofetilmikofenolat nije imao učinka na plodnost mužjaka štakora.
Keep the blister in outer carton in order to protect from light
• Čuvati u vanjskom pakiranju radi zaštite od svjetlosti
Measure 94 mL of purified water in a measuring cylinder.
Izmjerite 94 ml pročišćene vode u menzuri.
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole.
Kod istodobne primjene izavukonazola primijećen je porast AUC0-∞ MPA za 35%.
Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal and hepatic transplant patients.
Zbog opaženih velikih razlika u učestalosti određenih nuspojava lijeka kod primjene u različitim indikacijama, učestalost je navedena zasebno za bolesnike s bubrežnim presatkom i bolesnike s jetrenim presatkom.
Mouth, esophageal, gastric, duodenal, and intestinal ulcers often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis and colitis were commonly reported during the pivotal clinical trials.
U pivotalnim su kliničkim ispitivanjima često prijavljeni ulkusi u ustima, jednjaku, želucu, dvanaesniku i crijevima, često praćeni krvarenjem kao komplikacijom, kao i hematemeza, melena te hemoragijski oblici gastritisa i kolitisa.
Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed CellCept capsules at a dose of 750 mg twice daily (1.5 g daily dose).
CellCept kapsule smiju se propisivati samo bolesnicima tjelesne površine od najmanje 1,25 m2. Bolesnicima tjelesne površine od 1,25 do 1,5 m2 mogu se propisivati CellCept kapsule u dozi od 750 mg dvaput dnevno (dnevna doza od 1,5 g).
There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving CellCept in combination with other immunosuppressants.
Prijavljeni su slučajevi hipogamaglobulinemije povezani s rekurentnim infekcijama kod bolesnika koji su primali CellCept u kombinaciji s drugim imunosupresivima.
Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other immunosuppressants.
Prijavljena je hipogamaglobulinemija kod bolesnika koji primaju CellCept u kombinaciji s drugim imunosupresivima.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept:
Naročito, prije nego što počnete uzimati CellCept, recite svom liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova:
In particular, tell your doctor or nurse if you are taking any of the following medicines before you start CellCept:
Naročito, prije nego što počnete primati CellCept, recite svom liječniku ili medicinskoj sestri ako uzimate neki od sljedećih lijekova:
The daily dose is 10 mL suspension (2 g of the medicine) taken as 2 separate doses.
• Dnevna doza je 10 ml suspenzije (2 g lijeka), koja se uzima u 2 odvojene doze.
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
U toksikološkim ispitivanjima provedenima s mofetilmikofenolatom na štakorima, miševima, psima i majmunima bili su primarno pogođeni organi hematopoetskog i limfoidnog sustava.
• The daily dose is 15 mL suspension (3 g of the medicine) taken as 2 separate doses.
• Dnevna doza je 15 ml suspenzije (3 g lijeka), koja se uzima u 2 odvojene doze.
If you have any further questions on the use of this product, ask your doctor or nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili medicinskoj sestri.
IV CellCept should be administered for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated.
Intravenski oblik lijeka CellCept mora se primjenjivati prva 4 dana nakon presađivanja jetre, a s primjenom oralnog lijeka CellCept treba započeti čim to dozvoljava bolesnikovo stanje.
Skin problems such as: acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Probleme s kožom kao što su: akne, groznice, herpes zoster, kožne izrasline, gubitak kose, osip praćen svrbežom
Therefore, a change in the dose of CellCept should not normally be necessary in the absence of clinical evidence of graft dysfunction.
Stoga, ako nema kliničkih dokaza disfunkcije presatka, promjena doze lijeka CellCept obično nije potrebna.
Therefore, women of childbearing potential must use at least one form of reliable contraception (see section 4.3) before starting CellCept therapy, during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of contraception.
Stoga žene reproduktivne dobi moraju prije započinjanja liječenja, tijekom liječenja i još šest tjedana nakon prekida liječenja lijekom CellCept koristiti najmanje jedan pouzdan oblika kontracepcije (vidjeti dio 4.3), osim ako je kao metoda kontracepcije odabrana apstinencija.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA CellCept 1 g/5 ml prašak za oralnu suspenziju mofetilmikofenolat
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressants.
Prijavljeni su slučajevi izolirane aplazije eritrocita (engl.Pure Red Cell Aplasia, PRCA) kod bolesnika liječenih lijekom CellCept u kombinaciji s drugim imunosupresivima.
Powder for concentrate for solution for infusion: do not store above 30°C.
• Prašak za koncentrat za otopinu za infuziju: ne čuvati na temperaturi iznad 30°C.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 500 mg mycophenolate mofetil.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 500 mg mofetilmikofenolata.
Ecchymosis
Ekhimoza
NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion.
NAZIV LIJEKA CellCept 500 mg prašak za koncentrat za otopinu za infuziju.
The recommended dose of 1 g administered twice a day for renal or hepatic transplant patients is appropriate for the elderly.
Preporučena doza od 1 g primijenjena dvaput dnevno prikladna je za starije osobe s presađenim bubregom ili jetrom.
The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.
• Dnevna doza je 4 tablete (2 g lijeka), koje se uzimaju u 2 odvojene doze.
The recommended dose of CellCept for infusion in hepatic transplant patients is 1 g administered twice daily (2 g daily dose).
Preporučena doza infuzije lijeka CellCept za bolesnike s presađenom jetrom iznosi 1 g dvaput dnevno (dnevna doza od 2 g).
No pharmacokinetic data are available during hepatic transplant rejection.
Farmakokinetički podaci za slučaj odbacivanja presađene jetre nisu dostupni.
Esophagitis
Ezofagitis
You need to use the dispenser and bottle adapter supplied with the medicine to measure the dose.
Za odmjeravanje doze morate upotrijebiti dozator i plastični nastavak za bocu.
Reconstituted solution and the diluted solution: store between 15°C and 30°C.
• Pripremljenu otopinu i razrijeđenu otopinu čuvati na temperaturi od 15 do 30ºC
• tablet coating: hydroxypropyl methycellulose, hydroxypropyl cellulose, titanium dioxide
• ovojnica tablete: hipromeloza, hidroksipropilceluloza, titanijev dioksid (E171), polietilenglikol
Hyperglycemia
Hiperglikemija
Blood lactate dehydrogenase increased
Povišene vrijednosti laktat dehidrogenaze u krvi često manje često
The infusion flow rate should be controlled to equate to a 2-hour period of administration.
Brzinu infuzije treba namjestiti tako da primjena lijeka traje 2 sata.
Making up the medicine
Priprema lijeka
There is no information for the use of CellCept in children with a heart transplant.
• Nema podataka o primjeni lijeka CellCept u djece s presađenim srcem.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOCU
Note: 991 (2 g / 3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated in Phase III studies for the prevention of rejection in renal and hepatic transplantation, respectively
Napomena: U ispitivanjima faze III 991 bolesnik primao je CellCept u dozi od 2 g / 3 g na dan za sprječavanje odbacivanja bubrežnog presatka, dok je 277 bolesnika primalo CellCept u dozi od 2 g i.v. / 3 g peroralno na dan za sprječavanje odbacivanja jetrenog presatka.
• Do not mix the medicine with any other liquid when you swallow it. Close the bottle with the child safety bottle cap after each use.
Bocu zatvorite sigurnosnim zatvaračem za djecu nakon svake uporabe.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/005 CellCept (4 vials)
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/005 CellCept (4 bočice)
• CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90),
• CellCept kapsule: kukuruzni škrob, prethodno geliran, karmelozanatrij, umrežen, polividon (K90), magnezijev stearat
IV CellCept should continue for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated.
Tijekom prva 4 dana nakon presađivanja jetre treba nastaviti s intravenskom primjenom lijeka CellCept, a peroralna primjena lijeka CellCept treba započeti čim to dozvoljava bolesnikovo stanje.
NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil
CellCept 1 g/5 ml prašak za oralnu suspenziju mofetilmikofenolat
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 izloženost pri tim dozama je 2 - 3 puta veća od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan kod bolesnika s presađenim bubregom i 1,3 - 2 puta veća od kliničke izloženosti pri preporučenoj kliničkoj dozi od 3 g/dan kod bolesnika s presađenim srcem.
There have been reports of aplastic anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal.
U bolesnika liječenih lijekom CellCept prijavljeni su slučajevi aplastične anemije i zatajivanja koštane srži, od kojih su neki imali smrtni ishod.
METHOD AND ROUTE(S) OF ADMINISTRATION For oral administration
NAČIN I PUT(EVI) PRIMJENE LIJEKA
Azathioprine was the comparator used in the hepatic and cardiac studies and in two of the renal studies whilst the other renal study was placebocontrolled.
U ispitivanjima primjene nakon presađivanja jetre i srca i dvama ispitivanjima primjene nakon presađivanja bubrega usporedni je lijek bio azatioprin, dok je treće ispitivanje primjene nakon presađivanja bubrega bilo kontrolirano placebom.
• There is no information for the use of CellCept in children with a liver transplant.
• Nema podataka o primjeni lijeka CellCept u djece s presađenom jetrom.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/002 CellCept
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/002 CellCept
The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
• Dnevna doza je 6 tableta (3 g lijeka) koje se uzimaju u 2 odvojene doze.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/001 CellCept
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/001 CellCept
Edema
Edem
Do not use the tablets after the expiry date stated on the carton (EXP).
• Tablete se ne smiju upotrijebiti nakon isteka roka valjanosti navedenog na kutiji (Rok valjanosti).
Two vials of CellCept 500 mg powder for concentrate for solution for infusion are used for preparing each 1 g dose.
Za pripremu svake doze od 1 g upotrebljavaju se dvije bočice CellCept 500 mg praška za koncentrat za otopinu za infuziju.
CellCept should be administered with caution in patients with active serious digestive system disease.
Kod bolesnika s aktivnom ozbiljnom bolešću probavnog sustava CellCept se mora primjenjivati s oprezom.
• Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172),
• ovojnica kapsule: želatina, boja indigo karmin crvena (E132), željezov oksid, žuti (E172), željezov oksid, crveni (E172), titanijev dioksid (E171), željezov oksid, crni (E172), kalijev hidroksid, šelak
• Cellcept is provided in a 20 mL type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap.
• CellCept se nalazi u staklenim bočicama od 20 ml bezbojnog stakla tipa
However, in renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also section 4.4).
Čini se da CellCept nije promijenio koncentraciju takrolimusa kod bolesnika s presađenim bubregom (vidjeti i dio 4.4).
The daily dose is 2 g of the medicine taken as 2 separate doses.
• Dnevna doza je 2 g lijeka, u dvije odvojene doze.
Azathioprine was the comparator used in the hepatic study and in two of the renal studies whilst the other renal study was placebo-controlled.
U ispitivanju primjene nakon presađivanja jetre i dvama ispitivanjima primjene nakon presađivanja bubrega usporedni je lijek bio azatioprin, dok je treće ispitivanje primjene nakon presađivanja bubrega bilo kontrolirano placebom.
General disorders and administration site conditions Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal trials.
U pivotalnim je ispitivanjima vrlo često prijavljen edem, uključujući periferni edem, edem lica i edem skrotuma.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg mycophenolate mofetil. Excipient(s) with known effect
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 250 mg mofetilmikofenolata.
The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Preporučena doza za bolesnike s presađenim srcem iznosi 1,5 g dvaput dnevno (dnevna doza od 3 g).
PRCA may resolve with dose reduction or cessation of CellCept therapy.
Smanjenje doze ili prestanak liječenja lijekom CellCept može dovesti do povlačenja izolirane aplazije eritrocita.
Heart transplant Adults
Presađivanje srca
NAME OF THE MEDICINAL PRODUCT CellCept 500 mg film-coated tablets.
CellCept 500 mg filmom obložene tablete.
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of CellCept patients have developed cancer of the lymphoid tissues and skin.
Kod vrlo malog broja bolesnika koji uzimaju CellCept razvio se rak limfoidnog tkiva i kože, što se može dogoditi kod bolesnika koji uzimaju ovu vrstu lijeka (imunosupresivi).
Take off the child safety bottle cap.
2. Skinite sigurnosni zatvarač za djecu.
Skin and subcutaneous tissues disorders Acne
Poremećaji kože i potkožnog tkiva
Before you start taking CellCept
• razdoblje prije početka uzimanja lijeka CellCept
Some degree of enterohepatic recirculation is anticipated following intravenous administration of CellCept.
Pretpostavlja se da će se nakon primjene lijeka CellCept u venu pojaviti određeni stupanj enterohepatične recirkulacije.
HOW TO STORE CELLCEPT
KAKO ČUVATI CELLCEPT
The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to IV mycophenolate mofetil. 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.
Kod bolesnika s presađenom jetrom kod kojih je započeto liječenje lijekom CellCept i takrolimusom, istodobna primjena takrolimusa nije značajno utjecala na AUC i Cmax aktivnog metabolita lijeka CellCept, MPA . Nasuprot tome, kod bolesnika s presađenom jetrom koji su uzimali takrolimus, došlo je do povećanja AUC-a takrolimusa za otprilike 20% pri uzimanju višestrukih doza lijeka CellCept (1,5 g dvaput dnevno).
NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
CellCept 500 mg prašak za koncentrat za otopinu za infuziju mofetilmikofenolat
PHARMACEUTICAL FORM AND CONTENTS 100 Capsules
OBLIK I SADRŽAJ 4 bočice
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 500 mg mofetilmikofenolata u obliku mofetilmikofenolatklorida
SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
UPOZORENJE: CELLCEPT INTRAVENSKA OTOPINA NE SMIJE SE PRIMJENJIVATI U OBLIKU BRZIH INTRAVENSKIH INJEKCIJA ILI U OBLIKU BOLUSA.
The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Preporučena oralna doza za bolesnike s presađenom jetrom iznosi 1,5 g dvaput dnevno (dnevna doza od 3 g).
This will make sure that the bottle adapter and child safety bottle cap are in the right position.
• Na taj se način osigurava pravilan smještaj plastičnog nastavka za bocu i sigurnosnog zatvarača za djecu.
Heart and blood vessel problems such as: change in blood pressure, accelerated heartbeat widening of blood vessels.
• promjena krvnog tlaka, krvni ugrušci, ubrzani otkucaji srca
Diarrhea
Takrolimus
Nervous system problems such as: feeling drowsy or numb, tremor, muscle spasms convulsions, feeling anxious or depressed changes in your mood or thoughts.
• osjećaj tjeskobe ili depresije, promjene u raspoloženju ili razmišljanju
(E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), red iron oxide (E172).
400, boja indigo karmin crvena (E132), željezov oksid, crveni (E172)
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment.
Tijekom liječenja lijekom CellCept i najmanje 6 tjedana nakon prestanka liječenja ne smijete darivati krv.
acne, cold sores, skin growth, shingles, hair loss, rash, itching.
• akne, groznice, herpes zoster, kožne izrasline, gubitak kose, osip praćen svrbežom
• sinus problems.
• poteškoće sa sinusima
Respiratory, thoracic and mediastinal disorders Bronchiectasis
Poremećaji dišnog sustava, prsišta i sredoprsja Bronhiektazija manje često manje često
Read the package leaflet before use
Za primjenu kroz usta nakon pripreme
The recommended dose of oral CellCept in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Preporučena doza lijeka CellCept za peroralnu primjenu iznosi za bolesnike s presađenom jetrom 1,5 g dvaput dnevno (dnevna doza od 3 g).
Mouth ulceration
Ulkusi u ustima
As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of CellCept is correlated with MPA concentration.
Imunosupresivna aktivnost lijeka CellCept povezana je s koncentracijom MPA što je dokazano supresijom akutnog odbacivanja nakon transplantacije bubrega.
Interstitial lung disease
Intersticijska plućna bolest manje često vrlo rijetko
The active substance is mycophenolate mofetil.
Mikofenolatna kiselina (engl. mycophenolic acid, MPA) je aktivni metabolit mofetilmikofenolata.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Za bolesnike s presađenim srcem ili jetrom i teškim kroničnim oštećenjem bubrežne funkcije podaci nisu dostupni.
• congenital choroid plexus cyst;
• prirođene ciste na koroidnom pleksusu
Agitation
Konstipacija
Keep solutions at 15 - 30° C.
Otopine čuvajte na temperaturi od 15
Contents of the pack and other information What CellCept film coated tablet contains
Što CellCept filmom obložene tablete sadrže
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/002
STATEMENT OF ACTIVE SUBSTANCE(S) 5 ml suspension contains 1 g mycophenolate mofetil when reconstituted.
NAVOĐENJE DJELATNE(IH) TVARI 5 ml pripremljene suspenzije sadrži 1 g mofetilmikofenolata
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/004
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/004
NAME OF THE MEDICINAL PRODUCT CellCept 500 mg film-coated tablets Mycophenolate mofetil
CellCept 500 mg filmom obložene tablete mofetilmikofenolat
Use in hepatic transplant
Primjena kod presađivanja bubrega
Neoplasms
Mučnina
Lymphocele
FARMACEUTSKI
Very Common Very Common Very Common
Eruktacija manje često manje često često
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/006
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/006
4 Vials
4.8 Nuspojave
Hepatic impairment
• jetreni poremećaji
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/001
NAME OF THE MEDICINAL PRODUCT CellCept 500 mg tablets mycophenolate mofetil
CellCept 500 mg tablete mofetilmikofenolat
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/003
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/005
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/005
Uncommon Very Common Very Common
Dizgeuzija manje često manje često često
Vasodilatation
Vazodilatacija
Eructation
Cjepiva