natgillin/translations-raw huggingface dataset:
When reconstituted, the volume of the suspension is 175 mL, providing a usable volume of 160 - 165 mL.
Nakon rekonstitucije, količina suspenzije iznosi 175 ml, što daje iskoristivu količinu od 160 - 165 ml. 5 ml rekonstituirane suspenzije sadrži 1 g mofetilmikofenolata.
Patients with a body surface area greater than 1.5 m2 may be prescribed CellCept capsules at a dose of 1 g twice daily (2 g daily dose).
Bolesnicima tjelesne površine veće od 1,5 m2 mogu se propisivati CellCept kapsule u dozi od 1 g dvaput dnevno (dnevna doza od 2 g).
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid inhalation or direct contact with skin or mucous membranes of the dry powder as well as direct contact of the reconstituted suspension with the skin.
Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, treba izbjegavati udisanje ili izravan kontakt kože ili sluznica sa suhim praškom, kao i izravan kontakt rekonstituirane otopine s kožom.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
CONTENTS OF THE PACK AND OTHER INFORMATION
Sadržaj pakiranja i druge informacije
Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans.
• Pozadinske informacije o teratogenosti i mutagenosti mofetilmikofenolata u ljudi.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
U ispitivanju plodnosti i reprodukcije ženki, provedenom na štakorima, peroralne doze od 4,5 mg/kg/dan uzrokovale su malformacije (uključujući anoftalmiju, agnatiju i hidrocefalus) u prvom naraštaju potomaka, dok toksičnost za majku nije primijećena.
The full name of your medicine is CellCept 500 mg film-coated tablets.
Puno ime Vašeg lijeka je CellCept 500 mg filmom obložene tablete
The types of adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal and hepatic transplant studies.
Vrste nuspojava prijavljenih nakon stavljanja lijeka CellCept u promet slične su onima opaženima u kontroliranim ispitivanjima primjene nakon presađivanja bubrega i jetre.
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 at the recommended clinical dose of 2 g/day.
Najveća doza primijenjena u ispitivanjima karcinogenosti na životinjama rezultirala je 2 - 3 puta većom sistemskom izloženošću (AUC ili Cmax) od primijećene kod bolesnika s presađenim bubregom pri preporučenoj kliničkoj dozi od 2 g/dan.
CellCept tablets should only be prescribed to patients with a body surface area greater than 1.5 m2, at a dose of 1 g twice daily (2 g daily dose).
CellCept tablete smiju se propisivati samo bolesnicima tjelesne površine veće od 1,5 m2 u dozi od 1 g dvaput dnevno (dnevna doza od 2 g).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU
CellCept IV solution should never be administered by rapid or bolus intravenous injection.
CellCept IV otopina ne smije se primjenjivati u obliku brzih injekcija u venu ili u obliku bolusa.
The contents of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 mL of glucose intravenous infusion 5% each.
Sadržaj bočica CellCept 500 mg praška za koncentrat za otopinu za infuziju mora se otopiti s 14 ml glukoze 5% za infuziju u venu.
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m2 mycophenolate mofetil orally twice daily.
Farmakokinetički parametri ocijenjeni su kod 49 pedijatrijskih bolesnika s bubrežnim presatkom (u dobi od 2 do 18 godina) koji su dvaput dnevno peroralno primali 600 mg/m2 mofetilmikofenolata.
The first dose is given within 24 hours of the transplant operation.
• Prva doza se daje unutar 24 sata nakon presađivanja.
Multipacks containing 150 (3 packs of 50) tablets
Višestruko pakiranje sadrži 150 tableta (3 pakiranja od 50
Take care not to let the made-up medicine get onto your skin.
Pazite da pripremljen lijek ne dođe u kontakt s Vašom kožom.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section 4.4).
Pure Red Cell Aplasia, PRCA) kod bolesnika liječenih lijekom CellCept (vidjeti dio 4.4).
Renal and urinary disorders Blood creatinine increased
Poremećaji bubrega i mokraćnog sustava Povišena razina kreatinina u krvi
METHOD OF ADMINISTRATION For intravenous infusion only Read the package leaflet before use
NAČIN PRIMJENE LIJEKA Samo za infuziju u venu Prije uporabe pročitajte uputu o lijeku
If you have a rare problem with your metabolism called “phenylketonuria”, talk to your doctor before you start taking this medicine.
„fenilketonurija“, obratite se svome liječniku prije nego uzmete ovaj lijek.
CellCept 500 mg powder for concentrate for solution for infusion is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal or hepatic transplants.
CellCept 500 mg prašak za koncentrat za otopinu za infuziju indiciran je u kombinaciji s ciklosporinom i kortikosteroidima za profilaksu akutnog odbacivanja presatka kod bolesnika koji primaju alogene bubrežne ili jetrene presatke.
• CellCept should not be given to women who are breastfeeding (see section 4.6).
• CellCept se ne smije davati dojiljama (vidjeti dio 4.6).
OTHER SPECIAL WARNING(S), IF NECESSARY Do not breathe the powder before constitution or allow it to touch your skin Avoid skin contact with the reconstituted suspension
Ne udišite prašak prije pripreme i ne dozvolite doticaj praška s kožom Izbjegavajte doticaj kože s pripremljenom suspenzijom
Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to CellCept in combination with other immunosuppressants during pregnancy.
Nakon stavljanja lijeka u promet prijavljene su kongenitalne malformacije, uključujući višestruke malformacije, kod djece bolesnica koje su bile izložene lijeku CellCept u kombinaciji s drugim imunosupresivima tijekom trudnoće.
CellCept should be used together with other medicines: Ciclosporin and corticosteroids.
CellCept se mora koristiti zajedno s drugim lijekovima:
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Bolesnici koji primaju imunosupresivnu terapiju koja obuhvaća kombinaciju lijekova, uključujući CellCept, izloženi su povećanom riziku od nastajanja limfoma i drugih zloćudnih bolesti, osobito kože (vidjeti dio 4.8).
diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
• proljev, zatvor, mučnina, loša probava, gubitak apetita, vjetrovi
CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing 4 vials.
CellCept 500 mg prašak za koncentrat za otopinu za infuziju dostupan je u pakiranjima od 4 bočice.
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription as mycophenolate causes birth defects and miscarriage.
• ako ste žena koja bi mogla zatrudnjeti, a niste predočili negativan nalaz testa na trudnoću prije nego što
In patients with delayed renal graft function post-transplant, mean MPA AUC0-12h was comparable to that seen in post-transplant patients without delayed graft function.
Kod bolesnika kod kojih nakon presađivanja dolazi do odgođene funkcije presađenog bubrega srednja vrijednost AUC0-12 sati MPA mogla se usporediti s AUC-om MPA bolesnika kod kojih nakon presađivanja nije došlo do odgođene funkcije presađenog bubrega.
Tablet coating hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172)
Ovojnica tablete hipromeloza hidroksipropilceluloza titanijev dioksid (E171) polietilenglikol 400 indigo carmine aluminium lake (E132) željezov oksid, crveni (E172)
Then shake the closed bottle well for about another minute.
• Snažno tresite zatvorenu bočicu još 1 minutu.
Contents of the pack and other information
SADRŽAJ PAKIRANJA I OSTALE INFORMACIJE
Any unused product or waste material should be disposed of in accordance with local requirements.
Neiskorišten lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
Paediatric population aged 2 to 18 years The recommended dose of CellCept 1 g/5 ml powder for oral suspension is 600 mg/m2 administered twice daily (up to a maximum of 2 g/10 mL oral suspension daily).
Preporučena doza praška za oralnu suspenziju CellCept 1 g/5 ml iznosi 600 mg/m2 dvaput dnevno (do najviše 2 g/10 ml oralne suspenzije dnevno).
Capsule shells gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac.
Ovojnica kapsula želatina indigo karmin (E132) željezov oksid, žuti (E172) željezov oksid, crveni (E172) titanijev dioksid (E171) željezov oksid, crni (E172) kalijev hidroksid šelak.
• CellCept should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
• CellCept se ne smije koristiti u trudnoći, osim ako ne postoji prikladno alternativno liječenje kojim bi se spriječilo odbacivanje presatka (vidjeti dio 4.6).
CellCept capsules pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
CellCept kapsule kukuruzni škrob, prethodno geliran karmelozanatrij, umrežena polividon (K-90) magnezijev stearat
Package leaflet: Information for the user CellCept 1 g/5 ml powder for oral suspension (mycophenolate mofetil)
Uputa o lijeku: Informacije za korisnika CellCept 1 g/5 ml prašak za oralnu suspenziju (mofetilmikofenolat)
Do not use cloths or wipes for drying.
Dozator nemojte brisati krpom ili maramicom.
• Do not use the capsules after the expiry date stated on the carton (EXP).
• Kapsule se ne smiju upotrijebiti nakon isteka roka valjanosti navedenog na kutiji (Rok valjanosti).
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/006 CellCept (1 bottle 110g)
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/96/005/006 CellCept (1 bočica 110 g)
The full name of your medicine is CellCept 500 mg powder for concentrate for solution for infusion.
Puno ime Vašeg lijeka je CellCept 500 mg prašak za koncentrat za otopinu za infuziju.
Oral CellCept should be initiated within 5 days following transplantation.
CellCept u oralnom obliku mora se primijeniti unutar 5 dana nakon presađivanja.
CellCept 500 mg powder for concentrate for solution for infusion
CellCept 500 mg prašak za koncentrat za otopinu za infuziju
The pharmacokinetics of oral contraceptives were unaffected by co-administration of CellCept (see also section 4.5).
Istodobna primjena lijeka CellCept nije utjecala na farmakokinetiku oralnih kontraceptiva (vidjeti i dio 4.5).
MPA AUC values obtained following administration of 1 g BID intravenous CellCept to renal transplant patients in the early post-transplant phase are comparable to those observed following 1 g BID oral CellCept.
Vrijednosti AUC MPA primijećene nakon primjene intravenskog lijeka CellCept u dozi od 1 g dvaput dnevno kod bolesnika s presađenim bubregom u ranom razdoblju nakon presađivanja mogu se usporediti s onima primijećenima nakon primjene oralnog lijeka CellCept u dozi od 1 g dvaput dnevno.
In hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the active metabolite of CellCept, were not significantly affected by co-administration with tacrolimus.
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.
• The shelf-life of the reconstituted suspension is two months.
• Rok valjanosti pripremljene suspenzije je dva mjeseca.
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose), i.e. 5 mL oral suspension twice daily.
Preporučena doza za bolesnike s presađenim bubregom iznosi 1 g dvaput dnevno (dnevna doza od 2 g), tj. 5 ml oralne suspenzije dvaput dnevno.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Bolesnici koji primaju imunosupresivnu terapiju koja obuhvaća kombinaciju lijekova, uz ostalo i CellCept, izloženi su povećanom riziku od nastajanja limfoma i drugih zloćudnih bolesti, osobito kože (vidjeti dio 4.4).
Then put the tip of the dispenser firmly into the opening of the bottle adapter.
Čvrsto umetnite vrh dozatora u otvor plastičnog nastavka za bocu.
Oral CellCept should be initiated within 72 hours following transplantation.
Odrasli CellCept kapsule moraju se uzeti unutar 72 sata nakon presađivanja.
The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/day.
Sistemska izloženost pri tim dozama je 2 - 3 puta veća od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan.
1 bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
1 boca sadrži 35 g mofetilmikofenolata u 110 g praška za oralnu suspenziju.
CellCept 250 mg capsules
CellCept 250 mg kapsule
Elderly patients receiving CellCept as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Starije osobe koje primaju CellCept kao dio kombiniranog imunosupresivnog liječenja mogu u odnosu na mlađe pojedince biti izložene povećanom riziku od određenih infekcija (uključujući invazivnu citomegalovirusnu bolest tkiva), a vjerojatno i gastrointestinalnih krvarenja te plućnog edema.
Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Emil-Barell-Strasse 1
The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day.
Sistemska izloženost pri ovoj dozi iznosila je otprilike 0,5 puta od kliničke izloženosti pri preporučenoj kliničkoj dozi od 2 g/dan.
Mean plasma MPAG AUC0-12h was 2 - 3-fold higher than in post-transplant patients without delayed graft function.
Srednja vrijednost AUC0-12 h MPAG-a u plazmi bila je 2-3 puta veća nego kod bolesnika kod kojih nakon presađivanja nije došlo do odgođene funkcije presatka.
Manufacturing Authorisation holder responsible for batch release: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany.
Proizvođač odgovoran za puštanje serije lijeka u promet: Roche Pharma AG, Emil-Barell-Str.
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 at 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.
Najveća doza primijenjena u ispitivanjima karcinogenosti na životinjama rezultirala je 2 - 3 puta većom sistemskom izloženošću (AUC ili Cmax) od primijećene kod bolesnika s presađenim bubregom pri preporučenoj kliničkoj dozi od 2 g/dan te 1,3 - 2 puta većom sistemskom izloženošću (AUC ili Cmax) od primijećene kod bolesnika s presađenim srcem pri preporučenoj kliničkoj dozi od 3 g/dan.
It is recommended that the suspension be reconstituted by the pharmacist prior to dispensing to the patient
Preporučuje se da ljekarnik pripremi CellCept oralnu suspenziju neposredno prije izdavanja bolesniku
CellCept 1 g/5 ml powder for oral suspension is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
CellCept 1 g/5 ml, prašak za oralnu suspenziju, indiciran je u kombinaciji s ciklosporinom i kortikosteroidima za profilaksu akutnog odbacivanja presatka u primatelja alogenog bubrežnog, srčanog ili jetrenog presatka.
Hepatobiliary disorders Blood alkaline phosphatase increased
Poremećaji jetre i žuči Povišene vrijednosti alkalne fosfataze u krvi
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Nisu potrebne prilagodbe terapijske doze kod bolesnika s presađenim bubregom i teškom bolešću jetrenog parenhima.
The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum of 2 g daily).
Preporučena doza mofetilmikofenolata iznosi 600 mg/m2, primijenjena oralno dvaput dnevno (najviše 2 g dnevno).
CellCept tablets microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate
CellCept tablete celuloza, mikrokristalična polividon (K-90) karmelozanatrij, umrežena magnezijev stearat
• The first dose is given within 3 days of the transplant operation.
• Prva doza se daje unutar 3 dana nakon presađivanja.
values similar to those seen in adult renal transplant patients receiving CellCept at a dose of 1 g bid in the early and late post-transplant period.
Uz tu su dozu postignute vrijednosti AUC-a MPA slične vrijednostima opaženima u odraslih bolesnika s presađenim bubregom koji su primali 1 g lijeka CellCept dvaput dnevno u ranom i kasnom razdoblju nakon presađivanja.
Drugs which interfere with MPA's enterohepatic cycle (e.g. cholesterolamine, antibiotics) should be used with caution due to their potential to reduce the plasma levels and efficacy of CellCept (see also section 4.5).
Lijekove koji interferiraju s enterohepatičnom cirkulacijom MPA (npr. kolestiramin, antibiotici) treba primjenjivati uz oprez jer mogu sniziti plazmatske razine i djelotvornost lijeka CellCept (vidjeti također dio 4.5).
Hyperkalemia
Hiperkalijemija
• Powder for oral suspension: do not store above 30°C.
• Prašak za oralnu suspenziju: ne čuvati na temperaturi iznad 30°C.
Any unused product or waste material should be disposed of in accordance with local requirements
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima
Fungal infections
Gljivične infekcije
CellCept 1 g/5 ml powder for oral suspension contains aspartame.
Prašak za pripremu oralne suspenzije CellCept 1 g/5 ml sadrži aspartam.
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
CellCept je indiciran u kombinaciji s ciklosporinom i kortikosteroidima za profilaksu akutnog odbacivanja presatka u primatelja alogenog bubrežnog, srčanog ili jetrenog presatka.
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.
Ti su se učinci pojavili pri razinama sistemske izloženosti ekvivalentnim ili manjim od kliničke izloženosti pri preporučenoj dozi od 2 g/dan za bolesnike s presađenim bubregom.
Convulsion
Konvulzije
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg mycophenolate mofetil.
NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 250 mg mofetilmikofenolata.
This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
Na taj ćete način osigurati ispravan smještaj plastični nastavak za bočicu unutar bočice, kao i zaštitnu funkciju poklopca.
CellCept 500 mg film-coated tablets
CellCept 500 mg filmom obložene tablete
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Nisu dostupni podaci za bolesnike s presađenim srcem i teškom bolešću jetrenog parenhima.
Vascular disorders Hypertension
Krvožilni poremećaji Hipertenzija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadržava 500 mg mofetilmikofenolata (u obliku mofetilmikofenolatklorida).
The adverse drug reactions (ADRs) from clinical trials and post marketing experience are listed in Table 1, by MedDRA system organ class (SOC) along with their frequencies.
Tablici 1 navode se nuspojave prijavljene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet prema MedDRA klasifikaciji organskih sustava, zajedno s učestalošću njihova pojavljivanja.
CellCept 250 mg capsules:
CellCept kapsule 250 mg:
• If you are pregnant or planning to become pregnant or think you may be pregnant
• ako ste trudni, planirate zatrudnjeti ili mislite da biste mogli biti trudni
In hepatic transplant patients, administration of 1 g BID intravenous CellCept followed by 1.5 g BID oral CellCept resulted in MPA AUC values similar to those found in renal transplant patients administered 1 g CellCept BID.
Kod bolesnika s presađenom jetrom primjena intravenskog lijeka CellCept u dozi od 1 g dvaput dnevno, nakon koje je slijedila primjena oralnog lijeka CellCept u dozi od 1,5 g dvaput dnevno, rezultirala je vrijednostima AUC MPA sličnima onima primijećenima kod bolesnika s presađenim bubregom u kojih je primijenjen CellCept od 1 g dvaput dnevno.
How to take CellCept
Kako uzimati CellCept
No pharmacokinetic data with CellCept for infusion are available for paediatric renal transplant patients.
Za djecu s presađenim bubregom nisu dostupni farmakokinetički podaci o lijeku CellCept za infuziju.
Hypercholesterolemia
Hiperkolesterolemija
LIST OF EXCIPIENTS Also contains polysorbate 80, citric acid, hydrochloric acid and sodium chloride.
POPIS POMOĆNIH TVARI Pomoćne tvari: polisorbat 80, citratna kiselina, kloridna kiselina i natrijev klorid
Hypocalcemia
Hipokalcijemija
• Each bottle of 110 g powder for oral suspension contains 35 g of mycophenolate mofetil. Reconstitute with 94 mL of purified water.
• Jedna boca od 110 g praška za oralnu suspenziju sadrži 35 g mofetilmikofenolata.
(mycophenolate mofetil)
(mofetilmikofenolat)
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.
The first dose is given within 5 days of the transplant operation.
• Prva doza se daje unutar 5 dana od presađivanja.
Trimethoprim/sulfamethoxazole No effect on the bioavailability of MPA was observed.
Nije opažen učinak na bioraspoloživost MPA.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension.
NAZIV LIJEKA CellCept 1 g/5 ml prašak za oralnu suspenziju.
Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct contact of the dry powder or prepared solutions of CellCept 500 mg powder for concentrate for solution for infusion with skin or mucous membranes.
Budući da je mofetilmikofenolat pokazao teratogene učinke kod štakora i kunića, treba izbjegavati izravan kontakt suhog praška ili pripremljenih otopina CellCept 500 mg praška za koncentrat za otopinu za infuziju s kožom ili sluznicama.
Uncommon Very Rare
Hipogamaglobulinemija manje često vrlo rijetko vrlo rijetko
NAME OF THE MEDICINAL PRODUCT CellCept 250 mg capsules mycophenolate mofetil
NAZIV LIJEKA CellCept 250 mg kapsule mofetilmikofenolat
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Jedna boca sadrži 35 g mofetilmikofenolata u 110 g praška za oralnu suspenziju.