FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Irbesartan/Hydrochlorothiazide Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Għal aktar informazzjoni rigward il-kura b'Irbesartan/Hydrochlorothiazide Teva, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Irbesartan/Hydrochlorothiazide Teva huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Other information about Irbesartan/Hydrochlorothiazide Teva
Maltese: Aktar tagħrif dwar Irbesartan/Hydrochlorothiazide Teva
English: For more information on generic medicines, see the questionand-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument ta' mistoqsijiet u tweġibiet hawnhekk.
English: How does Irbesartan/Hydrochlorothiazide Teva work?
Maltese: Kif jaħdem Irbesartan/Hydrochlorothiazide Teva?
English: Irbesartan/Hydrochlorothiazide Teva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Maltese: Irbesartan/Hydrochlorothiazide Teva jintuża f'adulti li jkollhom ipertensjoni essenzjali (pressjoni għolja tad-demm) li ma tkunx ikkontrollata adegwatament b'irbesartan jew b'idroklorotijażid meħudin waħedhom. ‘Essenzjali' tfisser li l-ipertensjoni ma jkollhiex kawża evidenti.
English: (50 tablets)
Maltese: (50 pillola)
English: Date of latest renewal: 13 March 2006
Maltese: Data tal-aħħar tiġdid: 13 ta' Marzu 2006
English: CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor.
Maltese: CellCept huwa inibitur ta' IMPDH (inosine monophosphate dehydrogenase).
English: (100 capsules)
Maltese: (100 kapsula)
English: Preparation of Infusion Solution (6 mg/mL)
Maltese: Preparazzjoni tas-Soluzzjoni għall-Infużjoni (6 mg/mL)
English: (300 capsules)
Maltese: (300 kapsula)
English: * contains phenylalanine equivalent to 2.78 mg/5 mL of suspension.
Maltese: *fih phenylalanine ekwivalenti għal 2.78 mg/5 mL ta' suspensjoni.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Maltese: Roche Registration GmbH Emil-Barell-Strasse 1
English: Preparation of suspension
Maltese: Preparazzjoni tas-suspensjoni
English: CAUTION: CELLCEPT I.V.
Maltese: CELLCEPT SOLUZZJONI I.V.
English: Psychiatric disorders Confusional state
Maltese: Disturbi psikjatriċi Stat konfuż
English: Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A, antibiotics)
Maltese: Prodotti mediċinali li jinterferixxu maċ-ċirkolazzjoni enteroepatika mill-ġdid (eż. cholestyramine, ciclosporin A, antibijotiċi)
English: A detailed description of the preparation is given below:
Maltese: Deskrizzjoni dettaljata tal preparazzjoni qed tingħata hawn taħt:
English: taken twice a day.
Maltese: 2 g/jum.
English: Potential interaction
Maltese: Interazzjoni potenzjali
English: Vasodilatation
Maltese: Vasodilatazzjoni
English: Paediatric population aged 2 to 18 years
Maltese: Popolazzjoni pedjatrika b'età minn 2 sa 18-il sena
English: LIST OF EXCIPIENTS Also contains aspartame (E951) and methyl parahydroxybenzoate (E218).
Maltese: TA' EĊĊIPJENTI Fih ukoll aspartame (E951) u methyl parahydroxybenzoate (E218).
English: CellCept contains sorbitol (a type of sugar).
Maltese: · CellCept fih sorbitol (tip ta' zokkor).
English: Children (aged 2 to 18 years)
Maltese: Tfal (b'età minn 2 sa 18-il sena) ·
English: Antacids and proton pump inhibitors (PPIs)
Maltese: Antaċidi u inibituri tal-pompa tal-protoni (PPIs - proton pump inhibitors)
English: Renal transplant n = 991
Maltese: Trapjant talkliewi n = 991
English: • CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90),
Maltese: Kapsuli CellCept: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90),
English: (150 (3x50) tablets multipack)
Maltese: (pakkett multiplu ta' 150 (3x50) pillola)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Maltese: Roche Registration GmbH.
English: INFORMATION IN BRAILLE cellcept 500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE cellcept 500 mg
English: 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
Maltese: CellCept 1 g/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.
English: The usable volume of the reconstituted suspension is 160-165 ml.
Maltese: Il-volum li jista' jintuża tas-suspensjoni rikostitwita huwa 160-165 ml.
English: Fungal infections
Maltese: Infezzjonijiet fungali
English: Hepatic transplant n = 277
Maltese: Trapjant talfwied n = 277
English: CellCept 250 mg capsules:
Maltese: CellCept 250 mg kapsuli:
English: Keep solutions at 15 - 30° C.
Maltese: Żomm is-soluzzjonijiet f'temperatura ta' 15 - 30°C.
English: PHARMACEUTICAL FORM Powder for oral suspension.
Maltese: Trab għal suspensjoni orali.
English: Organic anion-transporting polypeptides (OATPs) and multidrug resistance-associated protein 2 (MRP2) are involved in MPA's disposition; OATP isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the glucuronides' biliary excretion.
Maltese: Polipeptidi li jġorru anjoni organiċi (OATPs - organic anion-transporting polypeptides) u proteina assoċjata ma' reżistenza għal diversi mediċini 2 (MRP2- multidrug resistance-associated protein 2) huma involuti fid-dispożizzjoni ta' MPA; isoformi ta' OATP, MRP2 u proteina ta' reżistenza għall-kanċer tas-sider (BCRP- breast cancer resistance protein) huma trasportaturi assoċjati mat-tneħħija biljari ta' glucuronides.
English: Hypercholesterolemia
Maltese: Iperkolesterolemija
English: Reconstituted solution and the diluted solution: store between 15°C and 30°C.
Maltese: Is-soluzzjoni rikostitwita u s-soluzzjoni dilwita: aħżen bejn 15°C u 30°C. ·
English: MPA at clinically relevant concentrations is 97% bound to plasma albumin.
Maltese: F'konċentrazzjonijiet li huma klinikament rilevanti MPA huwa 97% marbut mal-albumina tal-plażma.
English: Capsules, hard.
Maltese: Kapsuli, ibsin.
English: INFORMATION IN BRAILLE cellcept 250 mg
Maltese: INFORMAZZJONI BIL-BRAILLE cellcept 250 mg
English: Gastrointestinal ulcer
Maltese: Ulċera gastrointestinali
English: The proportion of patients with CMV viraemia/syndrome was 13.5%.
Maltese: Ilproporzjon ta' pazjenti b'viremija/sindrome b'CMV kien ta' 13.5%.
English: CellCept capsules pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
Maltese: Kapsuli CellCept pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate.
English: System Organ Class
Maltese: Klassifika tas-Sistemi u talOrgani
English: AcMPAG is pharmacologically active and is suspected to be responsible for some of MMF´s side effects (diarrhoea, leucopenia).
Maltese: AcMPAG huwa farmakoloġikament attiv u huwa ssuspettat li huwa responsabbli għal xi wħud mill-effetti sekondarji ta' MMF (dijarea, lewkopenija).
English: Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Maltese: Telmisartan ibiddel l-eliminazzjoni ta' MPA billi jtejjeb l-espressjoni ta' PPAR gamma (peroxisome proliferator-activated receptor gamma), li mbagħad iwassal għal titjib fl-espressjoni u lattività ta' UGT1A9.
English: Do not take CellCept:
Maltese: Tiħux CellCept:
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Maltese: Għalhekk għandu jiġi evitat f'pazjenti b'nuqqas ereditarju rari ta' hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) bħas-sindrome Lesch-Nyhan u Kelley-Seegmiller.
English: Note: If required, CellCept 1 g/5 ml powder for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Maltese: Nota: Jekk meħtieġ CellCept 1 g/5 ml trab għal suspensjoni orali jista' jingħata permezz ta' tubu nażogastriku b'daqs minimu ta' 8 French (dijametru interjuri ta' mill-anqas 1.7 mm).
English: Tracheo-Oesophageal malformations (e.g. oesophageal atresia); Nervous system malformations such as spina bifida;
Maltese: · Malformazzjonijiet tat-trakea u tal-esofagu (eż. atreżja tal-esofagu); · Malformazzjonijiet fis-sistema nervuża bħal spina bifida; ·
English: 1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10)
Maltese: kartuna 1 fiha 100 kapsula (f'pakketti tal-folja ta' 10) kartuna 1 fiha 300 kapsula (f'pakketti tal-folja ta' 10)
English: titanium dioxide (E171), black iron oxide (E172), potassium hydroxide, shellac.
Maltese: (E172), titanium dioxide (E171), iron oxide iswed (E172), potassium hydroxide, shellac.
English: CellCept tablets microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate
Maltese: Pilloli CellCept microcrystalline cellulose polyvidone (K-90) croscamellose sodium magnesium stearate.
English: Tablet coating hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172)
Maltese: Il-kisja tal-pillola hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132)
English: • rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis (TB)
Maltese: · rifampicin - antibijotiku użat għall-prevenzjoni u t-trattament ta' infezzjonijiet bħat-tuberkulożi (TB)
English: CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "ROCHE" name on the other.
Maltese: Pilloli CellCept: kulur vjola fl-aħmar ċar, tawwalin, imnaqqxa b'“CellCept 500” fuq naħa u l-isem “ROCHE” fuq in-naħa l-oħra.
English: An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of acute organ rejection.
Maltese: Total stmat ta' 1,557 pazjent irċevew CellCept matul ħames provi kliniċi dwar il-prevenzjoni ta' tiċħid akut ta' organu.
English: They have “CellCept 500” engraved on one side and “ROCHE” on the other.
Maltese: Għandhom “CellCept 500” imnaqqxa fuq naħa u “Roche” fuq in-naħa l-oħra.
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with CellCept.
Maltese: Tnaqqis fl-esponiment għal MPA kien osservat meta antaċidi, bħal magnesium u aluminium hydroxides, u PPIs, inkluż lansoprazol u pantoprazol, ingħataw flimkien ma' CellCept.
English: Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Maltese: Pazjenti ttrattati b'immunosoppressanti, inkluż CellCept, huma f'riskju akbar ta' infezzjonijiet opportunistiċi (ikkawżati minn batterja, fungus, virus u protożoa), infezzjonijiet fatali u sepsis (ara sezzjoni 4.8).
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m2 mycophenolate mofetil orally twice daily.
Maltese: Parametri farmakokinetiċi kienu evalwati f'49 pazjent pedjatriku bi trapjant renali (età ta' 2 sa 18-il sena) li ngħataw 600 mg/m2 ta' mycophenolate mofetil mill-ħalq darbtejn kuljum.
English: 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.
Maltese: Studju tal-għoti ta' CellCept (1 g bid) flimkien ma' kontraċettivi orali kombinati li fihom ethinylestradiol (0.02 mg sa 0.04 mg) u levonorgestrel (0.05 mg sa 0.15 mg), desogestrel (0.15 mg) jew gestodene (0.05 mg sa 0.10 mg) li sar fuq 18-il mara mingħajr trapjant (u li ma kinux qed jieħdu immunosoppressanti oħrajn) fuq medda ta' 3 ċikli mestruwali konsekuttivi ma wera l-ebda influwenza klinikament rilevanti ta' CellCept fuq l-azzjoni ta' soppressjoni tal-ovulazzjoni tal-kontraċettivi orali.
English: Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
Maltese: Kategorija farmakoterapewtika: sustanzi immunosoppressivi, Kodiċi ATC:
English: The most serious infections were sepsis, peritonitis, meningitis, endocarditis tuberculosis and atypical mycobacterial infection.
Maltese: L-aktar infezzjonijiet serji kienu sepsis, peritonite, meninġite, endokardite, tuberkulożi u infezzjoni atipika kkawżata minn mycobacteria.
English: A bottle adapter and 2 oral dispensers are also provided.
Maltese: Hemm ipprovdut ukoll adattatur tal-flixkun u 2 dispensers orali.
English: • Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Maltese: Aborti spontanji kienu rrappurtati f'45 sa 49% ta' nisa tqal esposti għal mycophenolate mofetil, imqabbla ma' rata rappurtata ta' bejn 12 u 33% f'pazjenti bi trapjant ta' organi solidi ttrattati b'immunosoppressanti oħra minbarra mycophenolate mofetil.
English: CellCept capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Maltese: Il-kapsuli CellCept għandhom jiġu preskritti biss lill-pazjenti li ġisimhom huwa ta' erja ta' mill-inqas 1.25 m2.
English: Musculoskeletal and connective tissue disorders Arthralgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: The final concentration of the solution is 6 mg/mL mycophenolate mofetil.
Maltese: Il-konċentrazzjoni finali tas-soluzzjoni hija 6 mg/mL mycophenolate mofetil.
English: There is evidence of a higher frequency of certain types of infections (see section 4.4).
Maltese: Hemm evidenza ta' frekwenza aktar għolja ta' ċertu tipi ta' infezzjonijiet (ara sezzjoni 4.4).
English: CellCept 1 g/5 ml powder for oral suspension contains aspartame.
Maltese: CellCept 1 g/5 ml trab għal suspensjoni orali fih aspartame.
English: Hypophosphatemia
Maltese: Ipofosfatemija
English: Manufacturing Authorisation holder responsible for batch release: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany.
Maltese: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Il-Ġermanja.
English: Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed CellCept capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Maltese: Pazjenti li ġisimhom huwa ta' erja ta' bejn 1.25 u 1.5 m2 jistgħu jiġu preskritti kapsuli CellCept f'doża ta' 750 mg darbtejn kuljum (doża ta' 1.5 g kuljum).
English: Hypersensitivity reactions to CellCept have been observed (see section 4.8).
Maltese: Kienu osservati reazzjonijiet ta' sensittività eċċessiva għal CellCept (ara sezzjoni 4.8).
English: CellCept 250 mg capsules
Maltese: CellCept 250 mg kapsuli.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of CellCept.
Maltese: Madankollu, norfloxacin u metronidazole flimkien naqqsu l-esponiment għal MPA b'madwar 30% wara doża waħda ta' CellCept.
English: Take 7.5 mL suspension in the morning and then 7.5 mL suspension in the evening.
Maltese: Ħu 7.5 mL ta' suspensjoni filgħodu u wara 7.5 mL ta' suspensjoni filgħaxija.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Maltese: Il-kategorija tal frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina hija bbażata fuq il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000) u rari ħafna (<1/10,000).
English: Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Maltese: Sevelamer Tnaqqis f'Cmax u fl-AUC0-12-il siegħa ta' MPA bi 30% u 25%, rispettivament, kien osservat meta CellCept ingħata flimkien ma' sevelamer mingħajr l-ebda konsegwenza klinika (i.e. tiċħid tat-trapjant).
English: Kidney transplant Adults
Maltese: Trapjant renali Adulti
English: In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Maltese: Fi studji dwar it-teratoġeniċità fil-firien u fil-fniek, resorbiment tal-fetu u malformazzjonijiet seħħew fil-firien f'dożi ta' 6 mg/kg/jum (inklużi anoftalmja, agnatja, u idroċefalu) u fil-fniek f'dożi ta' 90 mg/kg/jum (inklużi anomaliji kardjovaskulari u renali bħal pereżempju ectopia cordis u kliewi ektopiċi, u ftuq umbilikali u fid-dijaframma), fin-nuqqas ta' tossiċità materna.
English: Cardiac transplant n = 289
Maltese: Trapjant tal-qalb n = 289
English: 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/1.73 m2) were 28 - 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Maltese: 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/1.73 m2), kienu 28 - 75% ogħla meta mqabbla ma' medja osservati f'individwi normali f'saħħithom jew individwi b'indeboliment renali ta' gradi inqas gravi.
English: Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy;
Maltese: Mycophenolate huwa teratoġen qawwi fil-bnedmin, b'żieda fir-riskju ta' aborti spontanji u malformazzjonijiet konġenitali f'każ ta' esponiment waqt it-tqala; ·
English: • The other ingredients are sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, mixed fruit flavour, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), citric acid anhydrous.
Maltese: Is-sustanzi mhux attivi l-oħra huma sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, togħma ta' frott imħallat, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), citric acid anhydrous
English: LIST OF EXCIPIENTS Also contains polysorbate 80, citric acid, hydrochloric acid and sodium chloride.
Maltese: Fih ukoll polysorbate 80, citric acid, hydrochloric acid u sodium chloride.
English: 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).
Maltese: Id-doża rakkomandata ta' CellCept 1 g/5 ml trab għal suspensjoni orali hija ta' 600 mg/m2 mogħtija darbtejn kuljum (sa massimu ta' 2 g/10 mL ta' suspensjoni orali kuljum).
English: The active substance is mycophenolate mofetil.
Maltese: Is-sustanza attiva hi mycophenolate mofetil.
English: There have also been reports of bronchiectasis in children and adults.
Maltese: Kien hemm ukoll rapporti ta' bronkjektasi fi tfal u adulti.
English: Viral infections
Maltese: Infezzjonijiet virali
English: An estimated total of 1268 patients received CellCept during four clinical trials in the prevention of acute organ rejection.
Maltese: Total stmat ta' 1,268 pazjent irċevew CellCept matul erba' provi kliniċi dwar il-prevenzjoni ta' tiċħid akut ta' organu.
English: MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG).
Maltese: MPA huwa metabolizzat l-aktar minn glucuronyl transferase (isoforma UGT1A9) biex jifforma lglucuronide fenoliku mhux attiv ta' MPA (MPAG).
English: Sodium less than 1 mmol (23 mg) per dose For the full list of excipients, see section 6.1.
Maltese: Sodium anqas minn 1 mmol (23 mg) f'kull doża Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: CellCept contains mycophenolate mofetil.
Maltese: CellCept fih mycophenolate mofetil.
English: Contraception in women taking CellCept
Maltese: Mediċini oħra u CellCept
English: Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported from clinical trials and post marketing experience Adverse drug reaction (MedDRA)
Maltese: Tabella 1 Sommarju tar-reazzjonijiet avversi tal-mediċina li seħħew f'pazjenti ttrattati b'CellCept irrappurtati mill-provi kliniċi u mill-esperjenza wara t-tqegħid fis-suq Reazzjoni avversa tal-mediċina (MedDRA)
English: • CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium,
Maltese: Is-sustanzi mhux attivi l-oħra huma: · pilloli CellCept: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium,
English: Metabolism and nutrition disorders Acidosis
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Aċidożi
English: CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body.
Maltese: Kapsuli CellCept: oblung, blu/kannella, ittimbrati bl-iswed b'“CellCept 250” fuq l-għatu tal-kapsula u l-isem “Roche” fuq il-parti l-oħra.
English: Step 1 a.
Maltese: It-Tieni Stadju a.
English: • pneumonia, bronchitis,
Maltese: Problemi fil-pulmun bħal: · pnewmonja, bronkite,
English: The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Maltese: Il profil ta' tossiċità mhux klinika ta' mycophenolate mofetil jidher li huwa konsistenti mal-avvenimenti avversi osservati fi provi kliniċi umani li issa jipprovdu data dwar is-sigurtà ta' rilevanza akbar għall popolazzjoni ta' pazjenti (ara s-sezzjoni 4.8).
English: 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.
Maltese: Madankollu r-reazzjonijiet avversi relatati mat-trattament li ġejjin kienu aktar frekwenti filpopolazzjoni pedjatrika, speċjalment tfal taħt l-età ta' sitt snin, meta mqabbla ma' adulti: dijarea, sepsis, lewkopenija, anemija u infezzjoni.
English: Following single dose, oral 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).
Maltese: Cholestyramine Wara l-għoti ta' doża waħda mill-ħalq ta' 1.5 g ta' mycophenolate mofetil lil individwi normali f'saħħithom li kienu ttrattati minn qabel b'4 g TID ta' cholestyramine għal 4 ijiem, kien hemm tnaqqis ta' 40% fl-AUC ta' MPA (ara sezzjoni 4.4, u sezzjoni 5.2).
English: (see section 4.4, and section 5.2).
Maltese: AUC ta' MPA (ara sezzjoni 4.4 u sezzjoni 5.2).