natgillin/translations-raw huggingface dataset:
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).
Bolniki, ki prejemajo kombinacije imunosupresivnih zdravil, vključno z zdravilom CellCept, so izpostavljeni povečanemu tveganju nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4.8).
NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
If you take more CellCept than you should, talk to a doctor or go to a hospital straight away.
Če ste vzeli večji odmerek zdravila CellCept, kot bi smeli Če ste zaužili več zdravila CellCept, kot bi smeli, takoj obvestite zdravnika ali pojdite v bolnišnico.
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.
Zdravilo CellCept 500 mg prašek za koncentrat za raztopino za infundiranje je indicirano skupaj s ciklosporinom in kortikosteroidi za preprečevanje akutnih zavrnitvenih reakcij pri bolnikih z alogenim ledvičnim ali jetrnim presadkom.
How to take CellCept
Kako jemati zdravilo CellCept
The patient information pack should contain: · The Package Leaflet · Guide for patients
Gradivo za bolnike mora vsebovati:
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).
Bolniki, ki prejemajo imunosupresivna zdravila, obsegajoč kombinacije zdravil, vključno z zdravilom CellCept, imajo zvečano tveganje nastanka limfomov in drugih malignih sprememb, zlasti kožnih (glejte poglavje 4.4).
A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that there is a significant amount of enterohepatic recirculation.
Holestiramin v odmerku 4 g 3-krat na dan zmanjša AUC mikofenolne kisline za približno 40 %, kar potrjuje veliko stopnjo ponovnega enterohepatičnega obtoka.
Psychiatric disorders Confusional state
Psihiatrične motnje stanje zmedenosti depresija nespečnost
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.
Pri starejših bolnikih, ki prejemajo zdravilo CellCept kot del kombinacije imunosupresivnega režima, je v primerjavi z mlajšimi tveganje za pojav določenih okužb (vključno s citomegalovirusno tkivno invazivno boleznijo), krvavitev v prebavilih in pljučnega edema lahko večje.
The infusion flow rate should be controlled to equate to a 2-hour period of administration.
Hitrost infuzije je treba uravnati tako, da boste infuzijo prejeli v 2 urah.
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of CellCept is not required.
Zavrnitev ledvičnega presadka ne spremeni farmakokinetike mikofenolne kisline; zmanjšanje odmerkov ali prekinitev zdravljenja z zdravilom CellCept ni potrebna.
CellCept 1 g/5 ml powder for oral suspension sorbitol silica, colloidal anhydrous sodium citrate soybean lecithin mixed fruit flavour xanthan gum aspartame* (E951) methyl parahydroxybenzoate (E218) citric acid anhydrous
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi CellCept 1 g/5 ml prašek za peroralno suspenzijo sorbitol brezvoden koloidni silicijev dioksid natrijev citrat sojin lecitin mešana sadna aroma ksantanski gumi aspartam* (E951) metilparahidroksibenzoat (E218) brezvodna citronska kislina * vsebuje 2,78 mg fenilalanina v 5 ml suspenzije 6.2 Inkompatibilnosti
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.
Priporočeni odmerek pri bolnikih z ledvičnim presadkom je 1 g dvakrat na dan (dnevni odmerek 2 g), to je 5 ml peroralne suspenzije dvakrat na dan.
CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient (see section 6.6).
Pred dajanjem zdravila CellCept 500 mg prašek za koncentrat za raztopino za infundiranje bolniku, je potrebna rekonstitucija in nadaljnja razredčitev zdravila z intravensko infuzijo 5 % glukoze (glejte poglavje 6.6).
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section 4.4).
Pri zdravljenju z zdravilom CellCept so poročali o primerih čiste aplazije rdečih krvnih celic (PRCA) (glejte poglavje 4.4).
If you are a woman who could become pregnant you must use an effective method of contraception with CellCept.
Kontracepcija pri bolnicah, ki jemljejo zdravilo CellCept Če ste bolnica, ki bi lahko zanosila, morate med zdravljenjem z zdravilom CellCept uporabljati učinkovito kontracepcijsko zaščito, in sicer:
A study of the co-administration of CellCept (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of CellCept on the ovulation suppressing action of the oral contraceptives.
V študiji je 18 žensk brez presadka (drugih imunosupresivov niso jemale) sočasno prejemalo 1 g zdravila CellCept dvakrat na dan in kombinirane kontraceptive, ki so vsebovali etinilestradiol (0,02 mg do 0,04 mg) in levonorgestrel (0,05 mg do 0,15 mg), desogestrel (0,15 mg) ali gestoden (0,05 mg do 0,10 mg).
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).
Bolnikom s telesno površino nad 1,5 m2 predpišemo kapsule CellCept v odmerku 1 g dvakrat na dan (dnevni odmerek 2 g).
Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Nemčija.
Then put the tip of the dispenser firmly into the opening of the bottle adapter.
Nato v odprtino nastavka za steklenico trdno pritrdite vrh razdelilnika.
Therefore, women with 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.
Zato morajo bolnice v rodni dobi pred začetkom zdravljenja, med zdravljenjem in šest tednov po končanem zdravljenju z zdravilom CellCept uporabljati vsaj eno zanesljivo obliko kontracepcije (glejte poglavje 4.3), razen če niso izbrale metode vzdržnosti.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena steklenica vsebuje 35 g mofetilmikofenolata v 110 g praška za peroralno suspenzijo.
• There is no information for the use of CellCept in children with a liver transplant.
• Podatki o uporabi zdravila CellCept pri otrocih z jetrnim presadkom niso na voljo.
The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day.
Sistemska izpostavljenost pri tem odmerku je bila približno 0,5-krat tolikšna kot klinična izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan.
The shelf-life of the reconstituted suspension is 2 months.
Rok uporabnosti pripravljene suspenzije je 2 meseca.
A kidney, heart or liver.
• Presadek je lahko ledvični, srčni ali jetrni.
When reconstituted, the volume of the suspension is 175 mL, providing a usable volume of 160 - 165 mL.
Volumen pripravljene suspenzije je 175 ml, od tega je uporabnega volumna 160 do 165 ml. 5 ml pripravljene suspenzije vsebuje 1 g mofetilmikofenolata.
In some of these cases switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
V nekaj od teh primerov so se vrednosti serumskih IgG po zamenjavi zdravila CellCept z drugim imunosupresivom vrnile na normalo.
Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other immunosuppressants.
O hipogamaglobulinemiji so poročali pri bolnikih, ki so zdravilo CellCept prejemali v kombinaciji z drugimi imunosupresivi.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na kapsulo, kar v bistvu pomeni ‘brez natrija'.
They have “CellCept 500” engraved on one side and “ROCHE” on the other.
500” na eni in “ROCHE” na drugi strani.
Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss and congenital malformations at the beginning of the treatment and must be counseled regarding pregnancy prevention and planning.
Bolnice v rodni dobi se morajo zavedati, da obstaja večje tveganje za izgubo nosečnosti in kongenitalne malformacije na začetku zdravljenja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt).
Ena viala vsebuje ekvivalent 500 mg mofetilmikofenolata (v obliki klorovodikove soli).
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.
Opomba: v študijah faze III za preprečevanje zavrnitve presadka so vključili 991 bolnikov z ledvičnim presadkom (2 g/3 g zdravila CellCept na dan), 289 bolnikov s srčnim presadkom (3 g zdravila CellCept na dan) in 277 bolnikov z jetrnim presadkom (2 g i.v./3 g peroralne oblike zdravila CellCept na dan).
• Powder for oral suspension: do not store above 30°C.
• Prašek za peroralno suspenzijo: shranjujte pri temperaturi do 30 °C.
• 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.
• Zdravila ne mešajte z drugimi tekočinami, ko ga pogoltnete.
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.
V ključnih kliničnih preskušanjih so pogosto poročali o razjedah ust, požiralnika, želodca, dvanajstnika in črevesa, katerih pogosti zaplet je bila krvavitev, pa tudi bruhanje krvi, melena ter hemoragične oblike gastritisa in kolitisa.
Powder for concentrate for solution for infusion: do not store above 30°C.
Prašek za koncentrat za raztopino za infundiranje: shranjujte pri temperaturi do 30 °C.
Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in the faeces.
Peroralno zaužit in radioaktivno označen mofetilmikofenolat se je skoraj popolnoma izločil, od tega 93 % s sečem in 6 % z blatom.
Keep the blister in the outer carton in order to protect from light.
Pretisne omote shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
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.
Ker ima mofetilmikofenolat dokazane teratogene učinke pri podganah in kuncih, se je treba izogibati neposrednemu stiku praška ali pripravljene raztopine CellCept 500 mg prašek za koncentrat za raztopino za infundiranje s kožo ali sluznico.
Therefore, a change in the dose of CellCept should not normally be necessary in the absence of clinical evidence of graft dysfunction.
Zato v odsotnosti kliničnih znakov slabega delovanja presadka odmerka zdravila CellCept ponavadi ni potrebno spreminjati.
CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) infusion.
Zdravilo CellCept 500 mg prašek za koncentrat za raztopino za infundiranje je treba dati v obliki intravenske infuzije.
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.
By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Adsorbenti žolčnih kislin, kot je npr. holestiramin, vplivajo na enterohepatični obtok zdravila in s tem zmanjšajo AUC mikofenolne kisline (glejte poglavje 4.9).
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.
Nasprotno, po dajanju večkratnih odmerkov zdravila CellCept (1,5 g dvakrat na dan) bolnikom z jetrnim presadkom, ki so jemali takrolimus, se je AUC takrolimusa povečala za približno 20 %.
Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A, antibiotics)
Zdravila, ki vplivajo na glukuronidacijo (npr. izavukonazol, telmisartan)
Hernia
OVOJNINAH
METHOD AND ROUTE(S) OF ADMINISTRATION For oral administration
POSTOPEK IN POT(I) UPORABE ZDRAVILA za peroralno uporabo
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.
A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij - CellCept 500 mg prašek za koncentrat za raztopino za infundiranje - CellCept 1 g/5 ml prašek za peroralno suspenzijo:
There have been reports of aplastic anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal.
Pri bolnikih, ki so se zdravili z zdravilom CellCept, so poročali o primerih aplastične anemije in odpovedi kostnega mozga, nekateri od teh so bili smrtni.
In healthy volunteers, no significant interaction was observed when CellCept was concomitantly administered with norfloxacin or metronidazole separately.
Pri dajanju zdravila CellCept skupaj z norfloksacinom ali metronidazolom zdravim prostovoljcem pomembnega medsebojnega delovanja niso opazili.
Inspect the infusion solution for particulate matter or discoloration.
Preverite, da raztopina za infundiranje ne vsebuje vidnih delcev ali da ni razbarvana.
If you have a rare problem with your metabolism called “phenylketonuria”, talk to your doctor before you start taking this medicine.
»fenilketonurija«, se pred jemanjem tega zdravila posvetujte z zdravnikom.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt.
Ena viala vsebuje ekvivalent 500 mg mofetilmikofenolata v obliki klorovodikove soli.
This includes:
To storite tako, da:
• If you are pregnant or planning to become pregnant or think you may be pregnant
• če ste noseči, načrtujete nosečnost ali menite, da bi lahko bili noseči,
Then shake the closed bottle well for about another minute.
• Nato temeljito stresajte zaprto steklenico še približno 1 minuto.
It is recommended that CellCept 1 g/5 ml powder for oral suspension be reconstituted by the pharmacist prior to dispensing to the patient.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Priporočljivo je, da zdravilo CellCept 1 g/5 ml prašek za peroralno suspenzijo pred izdajo zdravila bolniku raztopi farmacevt.
Keep the blister in outer carton in order to protect from light
Pretisne omote shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
1 bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Ena steklenica vsebuje 35 mg mofetilmikofenolata v 110 g praška za peroralno suspenzijo.
• The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
• Dnevni odmerek je 8 kapsul (2 g zdravila), razdeljenih na 2 posamezna odmerka.
Tablet coating hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172)
Obloga tablet hipromeloza hidroksipropilceluloza titanov dioksid (E171) makrogol 400 indigotin (E132) rdeči železov oksid (E172)
• CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90),
• CellCept kapsule: predgeliran koruzni škrob, premrežen natrijev karmelozat, povidon (K90), magnezijev stearat;
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with CellCept.
Pri bolnikih, zdravljenih z zdravilom CellCept, so opazili posamezne primere nenormalne morfologije nevtrofilcev, vključno s pridobljeno Pelger-Huëtovo nepravilnostjo jedra granulocitov.
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of CellCept (see also section 5.2).
Sočasno jemanje zdravila CellCept ni vplivalo na farmakokinetiko in farmakodinamiko peroralnih kontraceptivov (glejte tudi poglavje 5.2).
• The daily dose is 15 mL suspension (3 g of the medicine) taken as 2 separate doses.
• Dnevni odmerek je 15 ml suspenzije (3 g zdravila), razdeljenih na dva posamezna odmerka.
General disorders and administration site conditions Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal trials.
V ključnih preskušanjih so zelo pogosto poročali o edemu, vključno s perifernim in obraznim edemom ter edemom skrotuma.
The active substance is mycophenolate mofetil.
Aktivni presnovek mofetilmikofenolata je mikofenolna kislina (MFK).
magnesium stearate
premrežen natrijev karmelozat magnezijev stearat
This belongs to a group of medicines called “immuno-suppressants”.
• Spada v skupino zdravil za zaviranje imunske odzivnosti.
Take off the child safety bottle cap.
Snemite za otroke varno zaporko.
Reconstituted solution and infusion solution: Store at 15 - 30°C.
Pripravljena raztopina in raztopina za infundiranje: shranjujte pri temperaturi med 15 °C in 30 °C.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/µl) it may be appropriate to interrupt or discontinue CellCept.
Če se pojavi nevtropenija (absolutno število nevtrofilcev < 1,3 x 103/μl),
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).
Zdravila, ki vplivajo na enterohepatični obtok mikofenolne kisline (npr. holestiramin, antibiotiki), je treba uporabljati previdno, saj lahko zmanjšajo plazemske koncentracije in učinkovitost zdravila CellCept (glejte tudi poglavje 4.5).
NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil
IME ZDRAVILA CellCept 1 g/5 ml prašek za peroralno suspenzijo mofetilmikofenolat
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m2 mycophenolate mofetil orally twice daily.
Farmakokinetične parametre so opazovali pri 49 otrocih in mladostnikih z ledvičnim presadkom (starih od 2 do 18 let), ki so prejemali 600 mg/m2 mofetilmikofenolata peroralno dvakrat na dan. Ti odmerki so dali podobne vrednosti AUC mikofenolne kisline kot pri odraslih bolnikih z ledvičnim presadkom, ki so prejemali zdravilo CellCept v odmerku 1 g dvakrat na dan v začetnem in poznejšem obdobju po presaditvi.
The first dose is given within 3 days of the transplant operation.
Odrasli • Prvi odmerek prejmete v 3 dneh po presaditvenem posegu.
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
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).
Liver transplant Adults
Presaditev jeter Odrasli
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.
V študijah preprečevanja zavrnitve jetrnega in srčnega presadka ter v dveh študijah preprečevanja zavrnitve ledvičnega presadka so kot primerjalno zdravilo uporabili azatioprin, tretja študija preprečevanja zavrnitve ledvičnega presadka pa je bila nadzorovana s placebom.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Za bolnike s srčnim ali jetrnim presadkom in hudo ledvično okvaro podatkov ni.
Do not stop taking CellCept unless your doctor tells you to.
Ne prenehajte jemati zdravila CellCept, ne da bi se prej posvetovali z zdravnikom.
The systemic exposure at this dose was approximately 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.
Sistemska izpostavljenost pri tem odmerku je bila približno 0,5-krat tolikšna kot klinična izpostavljenost pri priporočenem kliničnem odmerku 2 g na dan pri bolnikih z ledvičnim presadkom in približno 0,3-krat tolikšna kot klinična izpostavljenost pri priporočenem kliničnem odmerku 3 g na dan pri bolnikih s srčnim presadkom.
• Reconstituted suspension: do not store above 30°C.
• Pripravljeno suspenzijo: shranjujte pri temperaturi do 30 °C.
• The active substance is mycophenolate mofetil.
• Učinkovina je mofetilmikofenolat.
Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA.
Mofetilmikofenolat se po intravenski uporabi hitro in v celoti presnovi v aktivni presnovek mikofenolno kislino.
This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
Tako bo nastavek za steklenico pravilno nameščen, zaporka pa bo res varna za otroke.
MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/005 CellCept (4 vials)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/005/005 CellCept (4 viale)
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
Opomba: v študijah faze III za preprečevanje zavrnitve presadka so vključili 991 bolnikov z ledvičnim presadkom (2 g/3 g zdravila CellCept na dan) in 277 bolnikov z jetrnim presadkom (2 g i.v./3 g peroralne oblike zdravila CellCept na dan).
The daily dose is 10 mL suspension (2 g of the medicine) taken as 2 separate doses.
• Dnevni odmerek je 10 ml suspenzije (2 g zdravila), razdeljenih na dva posamezna odmerka.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
IME ZDRAVILA IN POT(I) UPORABE CellCept 500 mg prašek za koncentrat za raztopino za infundiranje mofetilmikofenolat