qanastek/EMEA-V3 huggingface dataset:
Patients should be advised that during treatment with CellCept, vaccinations may be less effective, and the use of live attenuated vaccines should be avoided (see section 4.5).
Il- pazjenti għandhom jiġu avżati li waqt il- kura b' CellCept, it- tilqim jista ’ jkun anqas effettiv u l- użu ta ’ tilqim b organiżmu ħaj għandu jiġi evitat (ara sezzjoni 4. 5).
CellCept 1 g/ 5 ml powder for oral suspension contains aspartame.
CellCept 1 g/ 5 ml trab għal suspensjoni orali fih aspartame.
Therefore, care should be taken if CellCept 1 g/ 5 ml powder for oral suspension is administered to patients with phenylketonuria (see section 6.1)
Għalhekk għandhu jkun hemm attenzjoni jekk CellCept 1 g/ 5 ml trab għal suspensjoni orali jiġi amministrat lil pazjenti b’ phenylketonuria (ara wkoll sezzjoni 6. 1)
This medicinal product contains sorbitol.
Dan il- prodott mediċinali fih sorbitol.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- fructose m’ għandhomx jieħdu din il- mediċina.
(see section 4.4, and section 5.2).
28 Cholestyramine: wara l- għotja ta ’ doża waħda ta '1. 5 g ta' mycophenolate mofetil lil individwi b' saħħithom li kienu kkuratati minn qabel b’ 4 g tliet darbiet kuljum ta ’ cholestyramine għal erbat ijiem, kien hemm tnaqqis ta ’ 40% fl- AUC ta ’ l- MPA (ara sezzjoni 4. 4 u sezzjoni 5. 2).
In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to patients taking tacrolimus.
B’ kuntrast, kien hemm żjieda ta ’ madwar 20% fl- AUC ta ’ tacrolimus meta dożi multipli ta 'CellCept (1. 5 g BID) ingħataw lil pazjenti li kienu qed jieħdu tacrolimus.
Thus, other substances known to undergo renal tubular secretion 29 may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
29 Għalhekk sustanzi li huma magħrufa li jgħaddu minn tneħħijatubulari renali, jistgħu jikkompetu ma ’ MPAG u b’ hekk jgħollu l- konċentrazzjonijiet fil- plażma ta ’ MPAG jew tas- sustanza l- oħra li tkun qed tgħaddi minn sekrezzjoni tubulari.
All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Infezzjonijiet opportunistiċi:
The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida
L- iktar infezzjonijiet opportunistiċi komuni
30 mucocutaneous, CMV viraemia/ syndrome and Herpes simplex.
30 f' pazjenti fuq CellCept (2 g jew 3 g kuljum) flimkien ma 'immunosoppressanti oħra fi provi kliniċi kkontrollati f’ pazjenti bi trapjant tal- kliewi (tagħrif ta ’ 2 g), tal- qalb u tal- fwied li ġew osservati għal mill - inqas sena kienu candida mukokutanja, viremija/ sindromu b’ CMV u Herpes simplex.
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/ m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g CellCept twice daily.
Fi studju kliniku fuq 92 pazjent pedjatriku b’ età minn sentenjn sa 18- il sena li ngħataw mycophenolate mofetil 600 mg / m2 mill- ħalq darbtejn kuljum, instab li t- tip u l- frekwenza tar- reazzjonijiet avversi ġeneralment kienu simili għal dawk osservati f’ pazjenti adulti li ngħataw 1 g ta 'CellCept darbtejn kuljum.
However, the following treatment-related adverse events were more frequent in the paediatric population, particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Madankollu r- reazzjonijiet avversi relatati mal- kura li ġejjin kienu aktar komuni fil- popolazzjoni pedjatrika, speċjalment tfal taħt l- età ta ’ sitt snin, meta mqabbla ma ’ adulti: dijarea, sepsis, lewkopenja, anemija u infezzjoni.
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.
Pazjenti anzjani li qed jirċievu CellCept bħala parti minn kors immunosoppressiv kombinat, jistgħu jkunu f' riskju akbar ta 'ċertu infezzjonijiet (inkluż mard b’ cytomegalovirus invasiv fit - tessut) u possibilment emorraġija gastro- intestinali u edima fil- pulmun meta mqabbla ma' individwi iżgħar.
Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Sepsis, kandidajażi gastro- intestinali, infezzjoni fl- apparat ta ’ l- awina, herpes simplex, herpes zoster
Very common
Komuni
-
Pnewmonja, influwenza, infezzjoni fl- apparat respiratorju, monolijażi respiratorja, infezzjoni gastro- intestinali, kandidajażi, gastroenterite, infezzjoni, bronkite, farinġite, sinusite, infezzjoni tal- ġilda mill- moffa, kandida tal - ġilda, kandidajażi tal- vaġina, rinite
polyps) Blood and lymphatic system disorders
Neoplażmi beninni, malinni u dawk mhux speċifikati (inkluż ċesti u polipi)
Common Very common Common
Komuni ħafna Komuni
Skin cancer, benign neoplasm of skin Leucopenia, thrombocytopenia, anaemia Pancytopenia, leucocytosis
- Kanċer fil- ġilda, neoplażma beninna tal- ġilda
Metabolism and nutrition disorders
Disturbi tad- demm u tas- sistema limfatika Disturbi fil- metaboliżmu u n -
Very common Common
Komuni ħafna Komuni Komuni ħafna
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Lewkopenja, tromboċitopenja, anemija Panċitopenja, lewkoċitożi -
Very common
nutrizzjoni
Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
Aċidożi, iperkalimja, ipokalimja, ipergliċemija, ipomagnesimja, ipokalċimja, iperkoleserolimja, iperlipidimja, ipofosfatimja, iperurikimja, gotta, anoressija
Nervous system disorders
Disturbi psikjatriċi
Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
Aġitazzjoni, stat konfuż, depressjoni, ansjetà, ħsibijiet mhux normali, nuqqas ta ’ rqad
Cardiac disorders
Disturbi fis- sistema nervuża
Vascular disorders
Disturbi fil- qalb Disturbi vaskulari Disturbi respiratorji, toraċiċi u
Very common
Komuni ħafna - Komuni Komuni ħafna - Komuni Komuni ħafna -
Hypotension, hypertension, vasodilatation
Takikardja Ipotensjoni, ipertensjoni, vażodilazzjoni
Respiratory, thoracic and mediastinal disorders
medjastinali
Very common Common
Komuni
- Pleural effusion, dyspnoea, cough
Effużjoni fil- plewra, qtugħ ta ’ nifs, sogħla
Gastrointestinal disorders
Disturbi gastro- intestinali
Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Komuni ħafna Rimettar, uġigħ fl- addome, dijarea, tqalligħ Komuni Fsada gastro- intestinali, peritonite, ileus, kolite, ulċera gastrika, ulċera fid- duwodenu, gastrite, osofaġite, stomatite, stitikezza, dispepsja, gass, tifwiq
Hepatitis, jaundice, hyperbilirubinaemia
Komuni ħafna - Komuni Epatite, suffejra, iperbilirubinimja
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ Komuni ħafna - taħt il- ġilda Disturbi muskolu- skeletrali u
Very common Common
Komuni Komuni ħafna -
- Skin hypertrophy, rash, acne, alopecia,
Ipertrofija tal- ġilda, raxx, akne, alopeċja
Musculoskeletal and connective Tissue disorders
tat- tessut konnettiv Disturbi fil- kliewi u fis- sistema
- Arthralgia
Artralġja
Renal and urinary disorders
urinarja Disturbi ġenerali u
Very common
Komuni Komuni ħafna -
Renal impairment
Indeboliment renali
General disorders and administration site conditions
kondizzjonijiet ta 'mnejn jingħata Investigazzjonijiet
Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
Edima, deni, tertir, uġigħ, tħossok ma tiflaħx, astenja Żieda ta ’ l- enżima epatika, żieda fil- krejatinina fid- demm, żieda tal- lactate dehydrogenase fid - demm, żieda fil- urea fid- demm, żieda tal - alkaline phosphatase fid- demm, tnaqqis fil- piż
32 Gastrointestinal: colitis including cytomegaloviruscolitis, (≥ 1/ 100 to < 1/ 10), pancreatitis (≥ 1/ 100 to < 1/ 10) and intestinal villous atrophy.
Kolite (inkluż kolite b’ cytomegalovirus), (≥1/ 100 sa < 1/ 10), pankrejatite, (≥1/ 100 sa < 1/ 10) u atrofija tal- villi fl- imsaren.
Disorders related to immunosuppression: serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
32 Disturbi relatati ma ’ immunosoppressjoni: infezzjonijiet serji li jipperikolaw il- ħajja inkluż meninġite, endokardite, tuberkulożi, u infezzjonijiet atipiċi mycobacteria.
Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Kienu rapportati reazzjonijiet ta ’ sensittività eċċessiva inkluż edima anġjonewrotika u reazzjoni anafilattika.
33 Mycophenolate mofetil is not measurable systemically in plasma following oral administration.
Mycophenolate mofetil ma jistax jitkejjel sistematikament fil- plażma wara li jittieħed mill- ħalq.
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6 – 12 hours post-dose.
33 Bħala riżultat tar- riċirkolazzjoni entero- epatika, żidiet sekondarji fil- konċentrazzjoni tal- plażma ta ’ MPA normalment huma osservati f’ madwar 6 – 12- il siegħa wara li tingħata d- doża.
Orally administered 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.
Mycophenolate mofetil radjutikketjat mogħti mill- ħalq jiġi rkuprat kompletament; b’ 93% tad- doża amministrata rkuprata fl - awrina u 6% tad- doża rkuprata fl- ippurgar.
In a single dose study (6 subjects/ group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25ml• min-1• 1.73 m-2) were 28 – 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Fi studju ta ’ doża waħda (6 individwi/ grupp), il- medja tal- AUC fil- plażma ta ’ MPA osservata f’ persuni b’ indeboliment kroniku renali sever (rata ta ’ filtrazzjoni glomerulari < 25 ml• min- 1• 1. 73 m- 2), kienu 28 – 75% ogħla meta mqabbla ma ’ medja osservati f’ individwi normali b’ saħħithom jew individwi b’ indeboliment renali ta ’ gradi inqas gravi.
34 Elderly patients (≥ 65 years):
Pazjenti anzjani (≥ 65 sena):
Oral contraceptives:
34 Kontraċettivi orali:
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.
L- ogħla doża eżaminata fl - istudji dwar il- karċinoġeniċità fuq l- annimali wasslu għal esponimenti madwar 2 – 3 darbiet ogħla mill - esponimenti sistemiċi (AUC jew Cmax) li kienu osservati f’ pazjenti bi trapjant renali fid- doża rakkomandata klinikament ta ’ 2 g/ jum u 1. 3 – 2 darbiet l- eponimenti sistemiċi (AUC jew Cmax) osservati f’ pazjenti bi trapjant tal- qalb fid- doża rakkomandata klinikament ta ’ 3 g/ jum.
The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in
Il- profil ta ’ tossiċità mhux kliniku ta ’ mycophenolate mofetil jidher li huwa konsistenti ma ’ l- avvenimenti avversi osservati fi provi kliniċi umani li issa jipprovdu tagħrif ta 'sigurtà ta' relevanza akbar għall- popolazzjoni ta ’ pazjenti (ara s - sezzjoni 4. 8).
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
CellCept 1 gm/ 5 ml trab għal suspensjoni orali: sorbitol silica colloidal anhydrous sodium citrate soybean lecithin togħma ta ’ frott imħallat xanthan gum aspartame * (E951) methyl parahydroxybenzoate (E218) citric acid, anhydrous. * fih phenylalanine ekwivalenti għal 2. 78 mg/ 5 ml ta 'suspensjoni.
The shelf-life of the powder for oral suspension is 2 years.
Iż- żmien kemm idum tajjeb it- trab għal suspensjoni orali huwa sentejn.
The shelf-life of the reconstituted suspension is 2 months.
Iż- żmien kemm iddum tajba s- suspensjoni rikostitwita huwa xahrejn.
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall -
Powder for oral suspension and reconstituted suspension:
Trab għal suspensjoni orali u s- suspensjoni rikostitwita:
Do not store above 30 °C.
Taħżinx f' temperatura ’ l fuq minn 30 °C.
Each bottle contains 110 g of powder for oral suspension.
Kull flixkun fih 110 g ta 'trab għal suspensjoni orali.
When reconstituted, the volume of the suspension is 175 ml, providing a usable volume of 160 – 165 ml.
Meta rikostitwit, il- volum tas- suspensjoni huwa 175 ml, u jipprovdi volum li jista ’ jintuża ta ’ 160- 165 ml.
A bottle adapter and 2 oral dispensers are also provided.
Hemm ipprovdut ukoll adattatur tal- flixkun u 2 dispensers.
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.
Minħabba li mycophenolate mofetil wera effetti teratoġeniċi fil- firien u fil- fniek, evita li t- trab niexef CellCept jittieħed man- nifs jew jiġi f’ kuntatt dirett mal- ġilda jew membrani mukużi, evita ukoll kuntatt dirett tas- suspensjoni rikostitwita mal- ġilda.
If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Jekk iseħħ kuntatt, aħsel sewwa bl- ilma u s- sapun; laħlaħ l - għajnejn b’ ilma naturali.
It is recommended that CellCept 1 g/ 5 ml powder for oral suspension be reconstituted by the pharmacist prior to dispensing to the patient.
Huwa rakkomandat li CellCept 1 g/ 5 ml trab għal suspensjoni orali jiġi rikostitwit mill- ispiżjar qabel ma jingħata lill- pazjent.
Preparation of suspension
Preparazzjoni tas- suspensjoni
Tap the closed bottle several times to loosen the powder.
Tektek il- flixkun magħluq diversi drabi biex it- trab ma jibqax magħqud.
Measure 94 ml of purified water in a graduated cylinder.
Kejjel 94 ml ta ’ ilma ppurifikat f’ ċilindru ggradwat.
Add approximately half of the total amount of purified water to the bottle and shake the closed bottle well for about 1 minute.
Żid madwar nofs l- ammont totali ta ’ ilma ppurifikat mal- flixkun u ħawwad sew il- flixkun magħluq għal madwar minuta.
Add the remainder of water and shake the closed bottle well for about 1 minute.
Żid il- kumplament ta ’ l- ilma u ħawwad sew il- flixkun magħluq għal madwar minuta.
Remove child-resistant cap and push bottle adapter into neck of bottle.
Neħħi it- tapp reżistenti għat- tfal u imbotta l- adattur tal- flixkun fl- għonq tal- flixkun.
Close bottle with child-resistant cap tightly.
Agħlaq sew il- flixkun bit- tapp reżistenti għat- tfal.
This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
Dan jassigura li l- adattur tal- flixkun jitqiegħed f’ postu fil- flixkun u li l- għatu huwa reżistenti għat- tfal.
Write the date of expiration of the reconstituted suspension on the bottle label.
Ikteb id- data ta ’ meta tiskadi s- suspensjoni rikostitwita fuq it- tiketta tal- flixkun.
(The shelf-life of the reconstituted suspension is two months.)
(Is- suspensjoni rikostitwita iddum tajba għal xahrejn)
(1 bottle 110g)
(flixkun ta ’ 110 g)
DATE OF REVISION OF THE TEXT
DATA TA 'META ĠIET RIVEDUTA L- KITBA
CellCept 500 mg tablets.
CellCept 500 mg pilloli.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITATTIVA U KWANTITATTIVA -
Each tablet contains 500 mg mycophenolate mofetil.
Kull pillola fiha 500 mg mycophenolate mofetil.
Film coated tablets.
Pilloli miksija b’ rita.
CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "Company logo" on the other.
Pilloli CellCept: kulur vjola fl- aħmar ċar, tawwalin, imnaqqxa b ’ "CellCept 500" fuq naħa u bil - “ logo tal - Kumpanija ” fuq in- naħa l- oħra.
4.1 Therapeutic indications
4. 1 Indikażzjonijiet terapewtici
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).
Il- pilloli CellCept għandhom jiġu preskritti biss lill- pazjenti li ġisimhom huwa ta ’ erja ta ’ aktar minn 1. 5 m2 f’ doża ta '1 g darbtejn kuljum (doża ta ’ 2 g kuljum).
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.
Peress li xi reazzjonijiet avversi jseħħu b’ iktar frekwenza f’ pazjenti ta 'din l - età (ara sezzjoni 4. 8) meta mqabbla ma ’ adulti, jista ’ jkun hemm bżonn li jew titwaqqaf il- mediċina għal ftit żmien jew titnaqqas id- doża; dawn ikollhom bżonn jieħdu f’ kunsiderazzjoni fatturi kliniċi relevanti inkluż s- severità tar- reazzjoni.
Use in hepatic transplant:
Użu fi trapjanti tal- fwied:
38 Adults:
38 Adulti:
39 Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
39 Pazjenti li qed jirċievu CellCept għandhom jiġu sorveljati għal newtropenja, li tista tkun relatata ma ’ CellCept innifsu, mediċini fl- istess waqt, infezzjonijiet virali jew xi taħlita ta ’ dawn il- kawżi.
(see section 4.4 and section 5.2).
Cholestyramine: wara l- għotja ta ’ doża waħda ta '1. 5 g ta' mycophenolate mofetil lil individwi b' saħħithom li kienu kkuratati minn qabel b’ 4 g tliet darbiet kuljum ta ’ cholestyramine għal erbat ijiem, kien hemm tnaqqis ta ’ 40% fl- AUC ta ’ l- MPA (ara sezzjoni 4. 4 u sezzjoni 5. 2).
Ciclosporin A: ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
40 Ciclosporin A: il- farmakokinetika ta 'ciclosporin A (CsA) mhix affetwata minn mycophenolate mofetil.
40 Ganciclovir: based on the results of a single dose administration study of recommended doses of oral mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics of CellCept (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Ganciclovir: ibbażat fuq riżultati ta ’ studju b’ għotja ta ’ doża waħda ta ’ dożi rakkomandata ta ’ mycophenolate orali u ganciclovir IV u l- effetti magħrufa ta ’ indeboliment renali fuq il- farmakokinetika ta ’ CellCept (ara sezzjoni 4. 2) u ganciclovir, huwa mbassar li l- għotja flimkien ta ’ dawn is- sustanzi (li jikkompetu għall- mekkaniżmi ta ’ sekrezzjoni tubulari mill- kliewi) tirriżultaw f’ żieda fil - konċentrazzjonijiet ta ’ MPAG u ganciclovir.
The antibody response to other vaccines may be diminished (see also 4.4).
Ir- rispons ta ’ l- antikorpi għal tilqim ieħor jista ’ jkun imnaqqas (ara wkoll sezzjoni 4. 4).
4.6 Pregnancy and lactation
41 4. 6 Tqala u Treddigħ
41 The use of CellCept is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
L- użu ta ’ CellCept mhux rakkomandat waqt it- tqala u għandu jiġi rriservat għall- każijiet fejn mhix disponibbli kura alternattiva xierqa.
All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4) The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/ syndrome and Herpes simplex.
L- iktar infezzjonijiet opportunistiċi komuni f' pazjenti fuq CellCept (2 g jew 3 g kuljum) flimkien ma 'immunosoppressanti oħra fi provi kliniċi kkontrollati f’ pazjenti bi trapjant tal- kliewi (tagħrif ta ’ 2 g), tal- qalb u tal- fwied li ġew osservati għal mill - inqas sena kienu candida mukokutanja, viremija/ sindromu b’ CMV u Herpes simplex.
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/ m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g CellCept twice daily.
Fi studju kliniku fuq 92 pazjent pedjatriku b’ età minn sentenjn sa 18- il sena li ngħataw mycophenolate mofetil 600 mg / m2 mill- ħalq darbtejn kuljum, instab li t- tip u l- frekwenza tar- reazzjonijiet avversi
Elderly patients receiving CellCept as part of a combination immunosuppressive
Ġeneralment, pazjenti anzjani (≥ 65 sena) jistgħu jkunu f' riskju akbar ta 'reazzjonijiet avversi minħabba immunosoppressjoni.
42 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.
Pazjenti anzjani li qed jirċievu CellCept bħala parti minn kors immunosoppressiv kombinat, jistgħu jkunu f' riskju akbar ta 'ċertu infezzjonijiet (inkluż mard b’ cytomegalovirus invasiv fit - tessut) u possibilment emorraġija gastro- intestinali u edima fil- pulmun meta mqabbla ma' individwi iżgħar.
- Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
- Aġitazzjoni, stat konfuż, depressjoni, ansjetà, ħsibijiet mhux normali, nuqqas ta ’ rqad
Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Konvulżjoni, ipertonija, rogħda, ħedla ta ’ ngħas, sindromu mijasteniku, sturdament, uġigħ ta ’ ras, parasteżija, disġeusja
Hepatobiliary disorders
Disturbi fil- qalb Disturbi vaskulari Disturbi respiratorji, toraċiċi u
Very common Common
Komuni ħafna - Komuni Komuni ħafna - Komuni Komuni ħafna -
Agranulocytosis (≥ 1/ 1000 to < 1/ 100) and neutropenia have been reported; therefore, regular monitoring of patients taking CellCept is advised (see section 4.4).
Kienu rrapportati agranuloċitożi (≥1/ 1000 sa < 1/ 100) u newtropenja; għalhekk hija rakkomandata osservazzjoni regolari ta ’ pazjenti li qed jirċievu CellCept (ara sezzjoni 4. 4).
Hypersensitivity:
44 Sensittività Eċċessiva:
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 44 4.4).
Huwa mistenni li doża eċċessiva ta ’ mycophenolate mofetil tista ’ possibilment twassal għal soppressjoni żejda tas- sistema mmuni u żieda fis- suxxettibilità għall- infezzjonijiet u soppressjoni tal- mudullun (ara sezzjoni 4. 4).
MPA at clinically relevant concentrations, is 97% bound to plasma albumin.
F’ konċentrazzjonijiet li huma klinikament relevanti MPA huwa 97% maqgħud mal- albumina tal- plażma.
A negligible amount of substance is excreted as MPA (< 1% of dose) in the urine.
45 Ammont negliġibbli tas- sustanza jitneħħa fl- awrina bħala MPA (< 1% tad- doża).
Orally administered 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.
Mycophenolate mofetil radjutikketjat mogħti mill- ħalq jiġi rkuprat kompletament; b’ 93% tad- doża amministrata rkuprata fl - awrina u 6% tad- doża rkuprata fl- ippurgar.
In a single dose study (6 subjects/ group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 ml• min-1• 1.73 m-2) were 28 – 75% higher 45 relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Fi studju ta ’ doża waħda (6 individwi/ grupp), il- medja tal- AUC fil- plażma ta ’ MPA osservata f’ persuni b’ indeboliment kroniku renali sever (rata ta ’ filtrazzjoni glomerulari < 25 ml• min- 1• 1. 73 m- 2), kienu 28 – 75% ogħla meta mqabbla ma ’ medja osservati f’ individwi normali b’ saħħithom jew individwi b’ indeboliment renali ta ’ gradi inqas gravi.
5.3 Preclinical safety data
46 5. 3 Tagħrif qabel l- użu kliniku dwar is- sigurtà tal- medicina
The systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical 46 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.
L- esponiment sistemiku f’ din id- doża jirrappreżenta 2 – 3 darbiet ogħla mill - esponiment kliniku fid- doża rakkomandata klinikament ta ’ 2 g/ jum f’ pazjenti bi trapjant renali u 1. 3 – 2 darbiet ogħla mill- esponiment kliniku ta ’ 3 g/ jum f’ pazjenti bi trapjant tal- qalb.
CellCept tablets: microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate
Pilloli CellCept: microcrystalline cellulose polyvidone (K90) croscamellose sodium magnesium stearate.
Tablet coating: hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172)
Ir- rita tal- pillola: hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) iron oxide aħmar( E172.)
Not applicable.
Ma jgħoddx f' dan il- każ.
47 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 30 °C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Keep the blister in the outer carton in order to protect from light.
Żomm il- folja fil- kartuna ta ’ barra sabiex tilqa mid- dawl.
CellCept 500 mg tablets:
CellCept 500 mg pilloli:
1 carton contains 50 tablets (in blister packs of 10) 1 carton contains 150 tablets (in blister packs of 10)
kartuna 1 fiha 50 pillola (f’ paketti tal- folja ta ’ 10) kartuna 1 fiha 150 pillola (f’ paketti tal- folja ta ’ 10)
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept tablets should not be crushed.
Minħabba li mycophenolate mofetil wera effetti teratoġeniċi fil- firien u fil- fniek, pilloli CellCept m’ għandhomx jitfarrku.
(50 tablets) (150 tablets)
(50 pillola) (150 pillola)
48 ANNEX II
49 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacture(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott.
- CellCept 500 mg powder for concentrate for solution for infusion
- CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni
- CellCept 1 g/ 5 ml powder for oral suspension:
- CellCept 1 g/ 5 ml trab għal suspensjoni orali:
1, 79639 Grenzach-Wyhlen, Germany.
1, 79639 Grenzach- Wyhlen, Il- Ġermanja.
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott.
- CellCept 250 mg capsules
- CellCept 250 mg kapsuli
- CellCept 500 mg tablets:
- CellCept 500 mg pilloli:
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
Not applicable.
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
LABELLING AND PACKAGE LEAFLET
Ma jgħoddx f’ dan il- każ.
51 A.
51 ANNESS III
LABELLING
TIKKETTA U FULJETT TA 'TAGĦRIF
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
OUTER CARTON
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CellCept 250 mg capsules Mycophenolate mofetil
CellCept 250 mg kapsuli Mycophenolate mofetil
100 Capsules
100 Kapsula
For oral administration Read the package leaflet before use
Għall- użu orali Aqra ’ l- fuljett ta ’ tagħrif qabel l- użu
CellCept capsules should be handled with care Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin
Il- kapsuli CellCept għandhom jiġu mmaniġġjati b’ attenzjoni Tiftaħx u tfarrakx il- kapsuli u tieħux it- trab ta ’ ġol- kapsuli ma ’ nifsek u tħalliħx imiss mal- ġilda tiegħek
Do not store above 30 °C Store in the original package in order to protect from moisture
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mill- umdità.
Any unused product or waste material should be disposed of in accordance with local requirements
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Limited, 6 Falcon Way Shire Park Welwyn Garden City, AL7 1TW Ir- Renju Unit
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKA ĠENERALI TA ’ KIF JINGĦATA
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each capsule contains 250 mg mycophenolate mofetil.
Kull kapsula fiha 250 mg mycophenolate mofetil
300 Capsules
300 Kapsula
CellCept capsules should be handled with care Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin
Il- kapsuli CellCept għandhom jiġu mmaniġġjati b’ attenzjoni Tiftaħx u tfarrakx il- kapsuli u tieħux it- trab ta’ ġol- kapsuli ma ’ nifsek u tħalliħx imiss mal- ġilda tiegħek
Do not store above 30 °C Store in the original package in order to protect from moisture
Taħżinx f’ temperatura ’ l fuq minn 30 °C Aħżen fil- pakkett oriġinali, sabiex tilqa ’ mill- umdità.
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOIL
FOLJA
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
58 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CellCept 500 mg powder for concentrate for solution for infusion Mycophenolate mofetil
500 mg CellCept trab għall- konċentrat għal soluzzjoni għall- infużjoni Mycophenolate mofetil
Each vial contains the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt.
Kull kunjett fih l- ekwivalenti ta ’ 500 mg mycophenolate mofetil bħala l- melħ tal- hydrochloride.
Also contains polysorbate 80, citric acid, hydrochloric acid and sodium chloride.
Fih ukoll polysorbate 80, citric acid, hydrochloric acid u sodium chloride.
4 Vials
4 Kunjetti
For intravenous infusion only Reconstitute and dilute before use Read the package leaflet before use
Għall- infużjoni fil- vini biss Irrikostitwixxi u iddilwixxi qabel l- użu Aqra ’ l- fuljett ta ’ tagħrif qabel l- użu
Avoid skin contact with infusion solution
Evita li s- soluzzjoni għall- infużjoni tiġi f’ kuntatt mal- ġilda
Do not store above 30°C
Taħżinx f’ temperatura ’ l fuq minn 30°C
59 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
CellCept 500 mg powder for concentrate for solution for infusion Mycophenolate mofetil
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni Mycophenolate mofetil
For intravenous infusion only Read the package leaflet before use
Għal infużjoni fil- vini biss Aqra ’ l- fuljett ta ’ tagħrif qabel l- użu
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
61 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL PAKKETT EWLIENI
CellCept 1 g/ 5 ml powder for oral suspension Mycophenolate mofetil
CellCept 1gm/ 5 ml trab għal supensjoni orali Mycophenolate mofetil
5 ml suspension contains 1 g mycophenolate mofetil when reconstituted.
Meta rikostitwita 5 ml tas- suspensjoni fiha 1 g ta ’ mycophenolate mofetil.
Also contains aspartame (E951) and methyl parahydroxybenzoate (E218).
Fih ukoll aspartame (E951) u methylparahydroxybenzoate (E218).
1 bottle with 110 g powder for oral suspension The usable volume of the reconstituted suspension is 160-165 ml 1 bottle adapter and 2 oral dispensers are provided
Flixkun 1 fih 110 g trab għal suspensjoni orali Il- volum li jista ’ jintuża tas- suspensjoni rikostitwita huwa 160 - 165 ml Huma pprovduti wkoll adattatur għall- flixkun u żewġ dispensers
For oral administration after constitution
Għall- użu orali wara rikostituzzjoni
Shake bottle well before use
Ħawwad il- flixkun sew qabel l- użu
It is recommended that the suspension be reconstituted by the pharmacist prior to dispensing to the patient
Huwa rakkomandat li s- suspensjoni tiġi rikostitwita mill- ispiżjar qabel ma tingħata lill- pazjent
Read the package leaflet before use
Aqra ’ l- fuljett ta ’ tagħrif qabel l- użu
Do not breathe the powder before constitution or allow it to touch your skin Avoid skin contact with the reconstituted suspension
Tieħux it- trab man- nifs qabel ir- rikostituzzjoni u tħalliħx imiss mal- ġilda tiegħek Evita li s- suspensjoni rikostitwita tiġi f' kuntatt mal- ġilda
Do not store above 30°C The shelf-life of the reconstituted suspension is 2 months
Taħżinx f’ temperatura ’ l fuq minn 30°C Id- data ta ’ skadenza tas- suspensjoni rikostitwita hija ta ’ xahrejn
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
63 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL PAKKETT EWLIENI
BOTTLE LABEL
TIKKETTA TAL- FLIXKUN
CellCept 1 g/ 5 ml powder for oral suspension Mycophenolate mofetil
CellCept 1 gm/ 5 ml trab għal supensjoni orali Mycophenolate mofetil
5 ml suspension contain 1 g mycophenolate mofetil when reconstituted.
Meta rikostitwita 5 ml tas- suspensjoni fiha 1 g ta ’ mycophenolate mofetil.
1 bottle with 110 g powder for oral suspension The usable volume of the reconstituted suspension is 160-165 ml 1 bottle adapter and 2 oral dispensers are provided
Flixkun 1 fih 110 g trab għal suspensjoni orali Il- volum li jista ’ jintuża tas- suspensjoni rikostitwita huwa 160 - 165 ml Huma pprovduti wkoll adattatur għall- flixkun u żewġ dispensers.
Shake bottle well before use
Għall- użu orali wara rikostituzzjoni Ħawwad il- flixkun sew qabel l- użu
Do not store above 30°C The shelf-life of the reconstituted suspension is 2 months Use before
Taħżinx f’ temperatura ’ ‘ l fuq minn 30°C Id- data ta ’ skadenza tas- suspensjoni rikostitwita hija ta ’ xahrejn Uża qabel
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit.
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CellCept 500 mg tablets Mycophenolate mofetil
CellCept 500 mg pilloli Mycophenolate mofetil
50 Tablets
50 Pillola
CellCept tablets should be handled with care Do not crush the tablets
Il- pilloli CellCept għandhom jiġu mmaniġġjati b’ attenzjoni Tfarrakx il- pilloli
Do not store above 30 °C Keep the blister in outer carton in order to protect from light
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen il- folja fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
150 Tablets
150 Pillola
CellCept tablets should be handled with care Do not crush the tablets
Il- kapsuli CellCept għandhom jiġu mmaniġġjati b’ attenzjoni Tfarrakx il- pilloli
Do not store above 30 °C Keep the blister in outer carton in order to protect from light
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen il- folja fil- kartuna ta ’ barra sabiex tilqa mid- dawl
68 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
69 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
CellCept 500 mg tablets Mycophenolate mofetil
CellCept 500 mg pillola Mycophenolate mofetil
70 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
CellCept 250 mg capsules mycophenolate mofetil
Kapsuli CellCept 250 mg mycophenolate mofetil
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina.
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even
Tista ’ tagħmlilhom il -
if their symptoms are the same as yours.
ħsara, anki jekk ikollom l- istess sintomi bħall tiegħek.
In this leaflet:
F' dan il- fuljett:
What CellCept is and what it is used for 2.
X' inhu CellCept u għalxiex jintuża 2.
Before you take CellCept 3.
Qabel ma ’ tieħu CellCept 3.
How to take CellCept 4.
Kif għandek tieħu CellCept 4.
Possible side effects 5.
Effetti sekondarji li jista 'jkollu 5.
How to store CellCept 6.
Kif taħżen CellCept 6.
WHAT CELLCEPT IS AND WHAT IT IS USED FOR
X' INHU CELLCEPT U GĦALXIEX JINTUŻA
Immunosuppressants.
Immunosoppressanti.
CellCept capsules are used to prevent your body rejecting a transplanted kidney, heart or liver.
Il- kapsuli CellCept jintużaw biex ma jħallux il- ġisem tiegħek jiċħad kilwa, qalb jew fwied trapjantati.
CellCept is used together with other medicines known as ciclosporin and corticosteroids.
CellCept jintuża flimkien ma 'mediċini oħra magħrufa bħala ciclosporin u kortikosterojdi.
BEFORE YOU TAKE CELLCEPT
QABEL MA ’ TIEĦU CELLCEPT
- If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
- Tieħux CellCept: Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mycophenolate
other ingredients of CellCept.
mofetil, mycophenolic acid, jew sustanzi oħra ta 'CellCept.
- If you are breastfeeding.
- Jekk qed tredda ’.
Take special care with CellCept:
Oqgħod attent ħafna b' CellCept:
You should inform your doctor immediately:
Għandek tinforma lit- tabib tiegħek minnufih:
- If you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising and/ or
- Jekk ikollok xi evidenza ta ’ infezzjoni (e. ż. deni, uġigħ fil- griżmejn), tbenġil u/ jew fsada bla
bleeding.
spjegazzjoni.
- If you have or ever have had any problems with your digestive system, e. g., stomach ulcers.
- Jekk għandek jew qatt kellek xi problemi bis- sistema diġestiva tiegħek e. ż., ulċeri fl- istonku.
CellCept reduces your body’ s defence mechanism.
CellCept inaqqas il- mekkaniżmu ta ’ difiża tal- ġisem tiegħek.
Because of this, there is an increased risk of skin cancer.
Minħabba f’ hekk, hemm riskju akbar ta ’ kanċer tal- ġilda.
Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Għalhekk għandek tillimita l- esponiment tiegħek għax- xemx u għar- raġġi UV billi tilbes ħwejjeġ protettivi xierqa u bl- użu ta ’ sunscreen b’ fattur protettiv għoli.
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
71 If you answer yes to any of the following questions talk to your doctor before you start to take CellCept:
72 Jekk twieġeb iva għal xi waħda minn dawn il- mistoqsijiet li ġejjin, kellem lit- tabib qabel ma tibda tieħu CellCept:
- Are you taking any medicines containing: azathioprine or other immunosuppressive agents
- Qed tieħu xi mediċini li fihom: azathioprine jew xi sustanzi immunosoppressivi oħra (li kultant
(which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
jingħataw lill- pazjenti wara operazzjoni ta ’ trapjant), cholestyramine (użat biex jikkura pazjenti b’ kolesterol fid- demm għoli), rifampicin (antibijotiku), antaċidi, phosphate binders (użati f’ pazjenti b’ insuffiċjenza renali kronika biex inaqqsu l- assorbiment tal- fosfat) jew xi mediċini oħra (anki dawk mingħajr riċetta) li t- tabib tiegħek ma jafx dwarhom?
- Do you need to receive vaccines (live vaccines)?
- Għandek bżonn tieħu vaċċini (vaċċini ħajjin)?
Your doctor will have to advise you what is
It- tabib tiegħek ikollu jagħtik parir dwar x’ inhu
indicated for you.
indikat għalik.
Taking CellCept with food and drink:
Meta tieħu CellCept ma ’ l- ikel u max- xorb:
Taking food and drink has no influence on your treatment with CellCept.
It- teħid ta ’ ikel u xorb ma għandu l- ebda effett fuq il- kura tiegħek b’ CellCept.
Pregnancy and breast-feeding:
Tieħux CellCept jekk qed tredda ’.
Do not take CellCept if you are breastfeeding.
M’ għandekx tuża CellCept waqt it- tqala sakemm mhux indikat b’ mod ċar mit- tabib tiegħek.
You must not use CellCept during pregnancy unless clearly indicated by your doctor. Your doctor should advise you about using contraception before taking CellCept, whilst taking CellCept, and for 6 weeks after you have stopped taking CellCept.
It- tabib tiegħek għandu jagħtik parir dwar l- użu ta ’ kontraċettivi qabel ma tieħu CellCept, waqt li qed tieħu CellCept u għal 6 ġimgħat wara li tieqaf tieħu CellCept.
This is because CellCept may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Dan minħabba li CellCept jista ’ jikkawża abort spontanju jew jagħmel ħsara, inkluż problemi fl- iżvilupp tal- widnejn, lit- tarbija tiegħek li għada ma twelditx.
Tell your doctor straight away if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Avża lit- tabib tiegħek minnufiħ jekk inti tqila, qed tredda ', toħroġ tqila jew qed tippjana biex tibda familja fil- futur qarib.
Driving and using machines:
Sewqan u tħaddim ta 'magni:
CellCept has not been shown to impair your ability to drive or operate machinery.
CellCept ma ntweriex li jfixkel il- ħila tiegħek biex issuq jew tħaddem magni.
HOW TO TAKE CELLCEPT
KIF GĦANDEK TIEĦU CELLCEPT
Always take CellCept exactly as your doctor has told you.
Dejjem għandek tieħu Cellcept skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubji.
The usual way to take CellCept is as follows:
Il- doża li ssoltu tingħata hija:
Kidney Transplant
Trapjant Renali
The first dose will be given within 72 hours after the transplant operation.
L- ewwel doża tingħata 72 siegħa wara li tkun saret l- operazzjoni tat- trapjant.
The recommended daily dose is 8 capsules (2 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija ta ’ 8 kapsuli (2 g tas- sustanza attiva) li tittieħed bħala żewġ dożi separati.
This means taking 4 capsules in the morning then 4 capsules in the evening.
Dan ifisser 4 kapsuli filgħodu u 4 kapsuli filgħaxija.
Children (aged 2 to 18 years):
Tfal (b’ età minn 2 sa 18- il sena):
The dose given will vary depending on the size of the child.
Id- doża mogħtija tvarja skond id- daqs tat- tifel/ tifla.
Your doctor will decide the most appropriate dose based on body surface area (height and weight).
It- tabib tiegħek għandu jiddeċiedi l- aktar doża xierqa skond l- erja tal- wiċċ tal- ġisem (tul u piż).
The recommended dose is 600 mg/ m2 taken twice a day.
Id- doża rakkomandata hija 600 mg/ m² li tittieħed darbtejn kuljum.
Heart Transplant
Trapjant tal- Qalb
The first dose will be given within 5 days following the transplant operation.
Adulti L- ewwel doża tingħata sa ħamest ijiem wara li tkun saret l- operazzjoni tat- trapjant.
The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija 12- il kapsula (3 g tas- sustanza attiva) li jittieħdu bħala żewġ dożi separati.
This means taking 6 capsules in the morning then 6 capsules in the evening.
Dan ifisser li trid tieħu 6 kapsuli filgħodu u wara 6 kapsuli filgħaxija.
72 Children:
Tfal:
No data are available to recommend the use of CellCept in children who have received a heart transplant.
M’ hemm l- ebda tagħrif disponibli biex jiġi rakkomandat l- użu ta ’ CellCept fi tfal li rċevew trapjant tal -
Liver Transplant
Trapjant tal- Fwied
The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications.
L- ewwel doża orali ta 'CellCept tingħatalek mill- inqas erbat ijiem wara li tkun saret l- operazzjoni tat - trapjant, u meta tkun tista ’ tibla ’ mediċini li jittieħdu mill- ħalq.
The recommended daily dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija ta ’ 12- il kapsula kuljum (3g tas- sustanza attiva) li tittieħed bħala żewġ dożi separati.
Children:
Tfal:
No data are available to recommend the use of CellCept in children who have received a liver transplant.
Ma hemm l- ebda tagħrif disponibli biex jiġi rakkomandat l- użu ta ’ CellCept fi tfal li rċevew trapjant tal - fwied.
Method and route of administration
Metodu ta 'kif u mnejn jingħata
Swallow your capsules whole with a glass of water.
Ibla ’ l- kapsuli sħaħ ma ’ tazza ilma.
Do not break or crush them and do not take any capsules that have broken open or split.
Tkissirhomx u tfarrakomx u tiħux kapsuli li huma mkissrin, miftuħin jew maqsuma.
Avoid contact with any powder that spills out from damaged capsules.
Evita kuntatt ma ’ trab li joħroġ minn kapsuli mkissrin.
If a capsule breaks open accidentally, wash any powder from your skin with soap and water.
Jekk xi kapsula tinqasam aċċidentalment, aħsel kull trab minn fuq il- ġilda tiegħek bis- sapun u l- ilma.
If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.
Jekk xi trab jidħol f' għajnejk jew ħalqek laħlaħhom sew b' ħafna ilma naturali u frisk.
Treatment will continue for as long as you need immunosuppression to prevent you rejecting your transplanted organ.
Il- kura tkompli sakemm ikollok bżonn immunosoppressjoni biex tipprevjeni li inti tiċħad l- organu trapjantat tiegħek.
If you take more CellCept than you should:
Jekk tieħu aktar CellCept milli suppost:
If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.
Jekk tieħu aktar kapsuli milli qalulek tieħu, jew jekk xi ħadd ieħor jieħu l- mediċina tiegħek bi żball, ara tabib jew mur l- isptar minnufih.
If you forget to take CellCept:
Jekk tinsa tieħu CellCept:
If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times.
Jekk f' xi ħin tinsa tieħu l- mediċina tiegħek, ħudha hekk kif tiftakar, wara kompli ħudha fil- ħinijiet tas - soltu.
If you stop taking CellCept:
Jekk tieqaf tieħu CellCept:
Stopping your treatment with CellCept may increase the chance of rejection of your transplanted organ.
Jekk twaqqaf il- kura tiegħek b’ CellCept tista ’ żżid ir- riskju ta ’ tiċħid ta ’ l- organu trapjantat tiegħek.