FrancophonIA/ELRC3.0 huggingface dataset:
English: Ethanol: 25 mg/capsule.
Maltese: Ethanol: 25 mg/kapsula.
English: Cases reporting chronic morphological changes included arteriolar hyalinosis, tubular atrophy and interstitial fibrosis (see section 4.4).
Maltese: Każijiet li rrappurtaw tibdiliet morfoloġiċi kroniċi inkludew jalinosi arterjali, atrofija tubulari u fibrożi interstizzjali (ara sezzjoni 4.4).
English: The recommended dose range is 2.5 to 5 mg/kg/day given in 2 divided oral doses.
Maltese: Ilfirxa tad-doża rrakkomandata hi ta' bejn 2.5 u 5 mg/kg/kuljum mogħtija f'2 dożi orali separati.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} {telefon} {fax} {e-mail}
English: Co-administration of ciclosporin with bosentan is not recommended (see above subsection “Drugs that decrease ciclosporin levels” and section 4.3).
Maltese: L-għoti flimkien ta' ciclosporin ma' bosentan mhuwiex irrakkomandat (ara s-sottosezzjoni “Mediċini li jnaqqsu l-livelli ta' ciclosporin” u sezzjoni 4.3).
English: - For subsequent use, follow steps 5 to 9.
Maltese: - Għad-drabi ta' wara, imxi ma' passi 5 sa 9.
English: Sandimmun concentrate for solution for infusion contains approximately 34.4 v/v ethanol (alcohol).
Maltese: Sandimmun konċentrat għal soluzzjoni għal infużjoni fih madwar 34.4 v/v ethanol (alkoħol).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ampoule contains 50 mg/mL ciclosporin
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ampulla fiha 50 mg/ml ciclosporin.
English: The intravenous LD50 is 148 mg/kg in mice, 104 mg/kg in rats, and 46 mg/kg in rabbits.
Maltese: L-LD50 mill-vina ta' ciclosporin hu ta' 148 mg/kg fil-ġrieden, 104 mg/kg fil-firien u 46 mg/kg fil-fniek.
English: - For initial use, follow steps 1 to 9.
Maltese: - Għall-ewwel darba, imxi ma' passi 1 sa 9.
English: The terminal half-life ranged from 6.3 hours in healthy volunteers to 20.4 hours in patients with severe liver disease.
Maltese: Il-half-life terminali tvarja minn 6.3 sigħat f'voluntiera b'saħħithom sa 20.4 sigħat f'pazjenti b'mard gravi tal-fwied.
English: Pharmacotherapeutic group: Immunosuppressive agents, calcineurin inhibitors, ATC code: L04AD01
Maltese: Aġenti immunosuppressivi, inibituri ta' calcineurin, Kodiċi ATC:
English: Sandimmun 100 mg soft capsules are dusty rose and oblong.
Maltese: Sandimmun 100 mg kapsuli rotob roża mutraba u oblungi.
English: Oedema, weight increase * Adverse events reported from post marketing experience where the ADR frequency is not known due to the lack of a real denominator.
Maltese: Edema, żieda fil-piż * Episodji avversi rrappurtati minn esperjenza wara t-tqegħid tal-prodott fis-suq fejn il-frekwenza talADR mhijiex magħrufa minħabba nuqqas ta' denominatur reali.
English: A limited number of observations in children exposed to ciclosporin in utero are available, up to an age of approximately 7 years.
Maltese: Numru limitat ta' osservazzjonijiet fi tfal esposti għal ciclosporin in utero huwa disponibbli, sal-età ta' madwar 7 snin.
English: Sandimmun contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients.
Maltese: Sandimmun fih madwar 12.0 vol. % ethanol (alkoħol), li jikkorrispondi għal 500 mg kull doża użata f'pazjenti bi trapjant.
English: You may need medical attention.
Maltese: Jaf ikollok bżonn ta' attenzjoni medika.
English: with products containing Hypericum perforatum (St John´s Wort).
Maltese: Prodotti li fihom Hypericum perforatum (St.
English: • Tiredness.
Maltese: • Aċċessjonijiet.
English: Drugs that increase ciclosporin levels
Maltese: Mediċini li jnaqqsu l-livelli ta' ciclosporin
English: Tabulated summary of adverse drug reactions from clinical trials Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class.
Maltese: Sommarju ttabulat ta' reazzjonijiet avversi tal-mediċina minn provi kliniċi Ir-reazzjonijiet avversi tal-mediċina minn provi kliniċi (Tabella 1) huma elenkati skont is-sistema talklassifika tal-organi.
English: A 500 mg dose of Sandimmun contains 500 mg ethanol, equivalent to nearly 15 ml beer or 5 ml wine.
Maltese: Doża ta' 500 mg Sandimmun fih 500 mg ethanol , ekwivalenti għal madwar 15 ml birra jew 5 ml nbid.
English: Sandimmun can be given in combination with low-dose corticosteroids and/or non-steroidal antiinflammatory drugs (NSAIDs) (see section 4.4).
Maltese: Sandimmun jista' jingħata flimkien ma' doża baxxa ta' kortikosterojdi u/jew ma' mediċini antiinfjammatorji mhux sterojdi (NSAIDs) (ara sezzjoni 4.4).
English: • You may have some side effects.
Maltese: • Jaf ikollok xi effetti sekondarji.
English: Ethanol: 50 mg/capsule.
Maltese: Ethanol: 50 mg/kapsula.
English: ml.
Maltese: HPLC).
English: • The total dose each day is usually between 3 to 5 mg per kilogram of your weight.
Maltese: • Id-doża totali għal kuljum hi normalment ta' bejn 3 u 5 mg għal kull kilogramma tal-piż tiegħek.
English: {Name of the Member State} {Name of the medicinal product} {Name of the Member State}{Name of the medicinal product}
Maltese: {Isem tal-Istat Membru} {Isem tal-prodott mediċinali} {Isem tal-Istat Membru} {Isem tal-prodott mediċinali}
English: Encephalopathy including Posterior Reversible Encephalopathy Syndrome (PRES), signs and symptoms such as convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis and cerebellar ataxia
Maltese: Enċefalopatija inkluż Sindrome Enċefalopatika Posterjuri Riversibbli (PRES), sinjali u sintomi bħalma huma konvulżjonijiet, konfużjoni, disorjentazzjoni, reazzjoni mnaqqsa, aġitazzjoni, nuqqas ta' rqad, disturbi fil-vista, għama kortikali, koma, pareżi u ataksja ċerebrali
English: The absolute oral bioavailability following administration of Sandimmun is 20 to 50%.
Maltese: Il-bijodisponibbiltà orali assoluta wara l-għoti ta' Sandimmun hi ta' bejn 20 u 50%.
English: In a study of 7 renal transplant patients aged 2-16 years, the ciclosporin clearance ranged from 9.8 to15.5 ml/min/kg.
Maltese: Fi studju ta' 7 pazjenti bi trapjant li għandhom bejn sentejn u sittax-il sena, it-tneħħija ta' ciclosporin kienet minn 9.8-15.5 ml/min/kg.
English: Combinations with increased risk for nephrotoxicity Care should be taken when using ciclosporin together with other active substances that exhibit nephrotoxic synergy such as: aminoglycosides (including gentamycin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole); fibric acid derivatives (e.g. bezafibrate, fenofibrate); NSAIDs (including diclofenac, naproxen, sulindac); melphalan histamine H2-receptor antagonists (e.g. cimetidine, ranitidine); methotrexate (see section 4.4).
Maltese: Kombinazzjonijiet b'żieda fir-riskju ta' nefrotossiċità Wieħed għandu joqgħod attent meta qed juża ciclosporin flimkien ma' sustanzi attivi oħrajn li jesebixxu sinerġija nefrotossika, bħal: aminoglycosides (inkluż gentamycin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole); derivattivi tal-aċdu fibriku (eż. bezafibrate, fenofibrate); NSAIDs (inkluż diclofenac, naproxen, sulindac); melphalan antagonisti tarriċettur tal-istamina H2 (eż. cimetidine, ranitidine); methotrexate (ara sezzjoni 4.4).
English: Ethanol: 100 mg/capsule.
Maltese: Ethanol: 100 mg/kapsula.
English: Special excipients: Sorbitol
Maltese: Sorbitol
English: Hypomagnesaemia
Maltese: Ipomagneżemija
English: Optic disc oedema, including papilloedema, with possible visual impairment secondary to benign intracranial hypertension
Maltese: Edima tad-disk ottiku, inkluż papilloedema, bi probabbiltà ta' indeboliment viżiv bħala riżultat ta' pressjoni għolja intrakranjali beninna Emikranja
English: Concomitant use of ciclosporin and tacrolimus should be avoided due to the risk for nephrotoxicity and pharmacokinetic interaction via CYP3A4 and/or P-gp (see section 4.4).
Maltese: L-użu flimkien ta' ciclosporin ma' tacrolimus għandu jkun evitat minħabba r-riskju ta' nefrotossiċità u ta' interazzjoni farmakokinetika permezz ta' CYP3A4 u/jew P-gp (ara sezzjoni 4.4).
English: • if you have kidney problems (except for nephrotic syndrome).
Maltese: • jekk għandek problema ta' fwied (ħlief sindrome nefrotiku).
English: • The other ingredients are: ethanol anhydrous, macrogolglycerol ricinolate/polyethoxynolated castor oil.
Maltese: • L-ingredjenti l-oħrajn huma: ethanol anhydrous, macrogolglycerol ricinolate/polyethoxynolated castor oil.
English: For severe rash, the treatment usually lasts for 8 weeks.
Maltese: F'każ ta' raxx gravi, it-trattament normalment idum 8 ġimgħat.
English: Table 1: Adverse drug reactions from clinical trials Blood and lymphatic system disorders Common
Maltese: Tabella 1: Reazzjonijiet avversi tal-mediċina minn provi kliniċi
English: Following concomitant administration of ciclosporin and lercanidipine, the AUC of lercanidipine was increased three-fold and the AUC of ciclosporin was increased 21%.
Maltese: Wara l-għoti flmkien ta' ciclosporin u lercanidipine, l-AUC ta' lercanidipine żdied bi tliet darbiet u lAUC ta' ciclosporin żdied b'21%.
English: • Nausea (feeling sick), vomiting, abdominal pain, constipation, diarrhoea.
Maltese: • Nawsea (tħossok imdardar), rimettar, uġigħ fl-addome, konstipazzjoni, dijarrea.
English: Paediatric population: Ciclosporin has been shown to be efficacious in steroid-dependent nephrotic syndrome.
Maltese: Intwera li ciclosporin hu effikaċji fil-każ ta' sindrome nefrotika dipendenti fuq sterojdi.
English: Motor polyneuropathy
Maltese: Polinewropatija motorika
English: Capsule content Ethanol anhydrous Maize oil interesterified Maize oil refined
Maltese: Ethanol anhydrous Maize oil interesterified Maize oil refined
English: Rifampicin induces ciclosporin intestinal and liver metabolism.
Maltese: Rifampicin jinduċi l-metaboliżmu ta' ciclosporin fl-imsaren u l-fwied.
English: The concentrate should be diluted 1:20 to 1:100 with normal saline or 5% glucose, and given as a slow intravenous infusion over approximately 2 to 6 hours.
Maltese: Il-konċentrat għandu jitħallat bejn 1:20 u 1:100 ma' soluzzjoni salina normali jew ma' 5% glukosju, u jingħata bil-mod bħala infużjoni mill-vina fuq medda ta' madwar sagħtejn u 6 sigħat.
English: Diltiazem (at doses of 90 mg/day) can increase ciclosporin plasma concentrations by up to 50%.
Maltese: Diltiazem (f'dożi ta' 90 mg/kuljum) jista' jżid il-konċentrazzjonijiet tal-plażma ta' ciclosporin sa 50%.
English: Menstrual disturbances, gynaecomastia General disorders and administration site conditions Common
Maltese: Disturbi menstrwali, ginekomastija
English: • Acne, hot flushes.
Maltese: • Akne, fwawar.
English: Capsule contents Ethanol anhydrous Maize oil interesterified Maize oil refined
Maltese: Il-kontenut tal-kapsula Ethanol anhydrous Maize oil interesterified Maize oil refined
English: LIST OF EXCIPIENTS Also contains: Ethanol anhydrous, macrogolglycerol ricinoleate/polyethoxylated castor oil
Maltese: TA' EĊĊIPJENTI Fih ukoll: Ethanol anidru, macrogolglycerol ricinoleate/polyethoxylated castor oil
English: A frequent and potentially serious complication, an increase in serum creatinine and urea, may occur during Sandimmun therapy.
Maltese: Jista' jkun hemm kumplikazzjoni serja frekwenti u potenzjali, jiġifieri żieda fil-kreatinina tas-serum u urea, matul it-terapija b'Sandimmun.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 100 mg ciclosporin
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml fih 100 mg ciclosporin.
English: Pregnant rats which received 12 mg/kg/day of ciclosporin intravenously (twice the recommended human intravenous dose) had foetuses with an increased incidence of ventricular septal defect.
Maltese: Firien tqal mogħtija 12 mg/kg/kuljum ciclosporin mill-vina (darbtejn id-doża rrakkomandata għall-bnedmin mill-vina) kellhom feti b'inċidenza miżjuda ta' diffett septali ventrikulari.
English: Concomitant administration of dabigatran extexilate is not recommended due to the P-gp inhibitory activity of ciclosporin (see section 4.3).
Maltese: L-għoti flimkien ta' dabigatran extexilate mhuwiex irrakkomandat minħabba l-attività inibitorja tal-Pgp ta' ciclosporin (ara sezzjoni 4.3).
English: One ml oral solution contains 100 mg ciclosporin.
Maltese: U KWANTITATTIVA ml 1 ta' soluzzjoni orali fiha 100 mg ciclosporin.
English: Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide consisting of 11 amino acids.
Maltese: Ciclosporin (magħruf ukoll bħala ciclosporin A) hu polipeptide ċikliku li fih 11-il aċdu aminiku.
English: Imatinib could increase ciclosporin exposure and Cmax by around 20%.
Maltese: Imatinib jista' jżid l-espożizzjoni ta' ciclosprin u s-Cmax b'madwar 20%.
English: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: CARTON AND BOTTLE LABEL
Maltese: TIKKETTA TAL-KARTUNA U TAL-FLIXKUN
English: Capsule,soft
Maltese: U KONTENUT Kapsula, ratba
English: Table 1 Summary of exposure changes of commonly used statins with ciclosporin
Maltese: Tabella 1 Sommarju tat-tibdiliet fl-espożizzjoni ta' statini użati b'mod komuni ma' ciclosporin
English: This belongs to a group of medicines known as immunosuppressive agents.
Maltese: Dan jappartjeni għal grupp ta' mediċini msejħin aġenti immunosuppressivi.
English: In two published research studies, rabbits exposed to ciclosporin in utero (10 mg/kg/day subcutaneously) demonstrated reduced numbers of nephrons, renal hypertrophy, systemic hypertension, and progressive renal insufficiency up to 35 weeks of age.
Maltese: F'żewġ studji ta' riċerka ppubblikati, l-espożizzjoni tal-fniek għal ciclosporin in utero (10 mg/kg/kuljum minn taħt il-ġilda) wrew għadd imnaqqas ta' nefroni, ipertrofija renali, pressjoni għolja sistemika, u insuffiċjenza renali progressiva sa 35 ġimgħa ta' età.
English: Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and/or life-threatening events, e.g. bosentan, dabigatran etexilate and aliskiren (see section 4.5).
Maltese: L-użu flimkien ma' mediċini li huma sottostrati għat-trasportatur tal-effluss tal-multimediċina Pglikoproteina u tal-proteini trasportaturi tal-anjon organiku (OATP) u li minħabba f'hekk konċentrazzjonijiet għolja tal-plażma huma assoċjati ma' episodji serji u/jew ta' theddida għall-ħajja, eż. bosentan, dabigatran etexilate u aliskiren (ara sezzjoni 4.5).
English: Metabolism mainly takes place in the liver via cytochrome P450 3A4 (CYP3A4), and the main pathways of metabolism consist of mono- and dihydroxylation and N-demethylation at various positions of the molecule.
Maltese: Il-metaboliżmu jseħħ laktar fil-fwied permezz taċ-ċitokromu P450 3A4 (CYP3A4), u l-mogħdijiet ewlenin tal-metaboliżmu jikkonsistu f'mono- u di-idroksilazzjoni u N-demetilazzjoni f'pożizzjonijiet varji tal-molekula.
English: Each ampoule of 5 ml contains 250 mg of ciclosporin.
Maltese: Kull kunjett ta' 5 ml fih 250 mg ciclosporin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Ciclosporin [To be completed nationally]
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Ciclosporin [Biex timtela mill-pajjiż partikolari]
English: Nausea, vomiting, abdominal discomfort/pain, diarrhoea, gingival hyperplasia, peptic ulcer
Maltese: Dardir, rimettar, skumdità/uġigħ addominali, dijarrea, iperplasija ġenġivali, ulċera peptika Pankreatite
English: Acne, hypertrichosis
Maltese: Akne, ipertrikożi
English: Patients receiving calcineurin inhibitor (CNI) therapies, including ciclosporin and ciclosporincontaining regimens, are at increased risk of acute or chronic nephrotoxicity.
Maltese: Pazjenti mogħtija terapiji bl-inibitur calcineurin (CNI), inkluż ciclosporin u trattamenti mediċi li fihom iċ-ciclosporin, jinsabu f'riskju aktar ta' nefrotossiċità akuta jew kronika.
English: Polyethoxylated castor oil and anaphylactoid reactions Sandimmun concentrate for solution for infusion contains polyethoxylated castor oil, which has been reported to cause anaphylactoid reactions following intravenous administration.
Maltese: Polyethoxylated castor oil u reazzjonijiet anafilattojdi Sandimmun konċentrat għal soluzzjoni għall-infużjoni fih polyethoxylated castor oil, li ġie rrappurtat li joħloq reazzjonijiet anafilattojdi wara li jingħata mill-vina.
English: Uncommon side effects: These side effects may affect between 1 and 10 in every 1,000 people.
Maltese: Effetti sekondarji mhux komuni: Dawn l-effetti sekondarji jistgħu jaffettwaw bejn pazjent u 10 pazjenti f'kull 1,000.
English: What Sandimmun looks like and contents of the pack Sandimmun comes in the form of an oral solution.
Maltese: Kif jidher Sandimmun u l-kontenut tal-pakkett Sandimmun jiġi fil-forma ta' soluzzjoni orali.
English: • if you have kidney problems.
Maltese: • jekk għandek problemi fil-kliewi.
English: Patients receiving immunosuppressive therapies, including ciclosporin and ciclosporin-containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic) (see section 4.4).
Maltese: Pazjenti mogħtija terapiji immunosuppressivi, inkluż ciclosporin u trattament mediku li fihom iċciclosporin, jinsabu f'riskju akbar ta' infezzjonijiet (virali, batteriċi, fungali, parasittiċi) (ara sezzjoni 4.4).
English: • Stomach ulcer.
Maltese: • jekk inti tqila.
English: The 1-ml syringe is used to measure doses less than or equal to 1 ml (each graduation of 0.05 ml corresponds to 5 mg of ciclosporin).
Maltese: Is-seringa ta' ml 1 tintuża biex jitkejlu d-dożi ta' anqas minn jew daqs ml 1 (kull gradwazzjoni ta' 0.05 ml tikkorrispondi għal 5 mg ciclosporin).
English: Oral solution
Maltese: Soluzzjoni orali
English: Sandimmun oral solution and soft gelatin capsules are bioequivalent.
Maltese: Sandimmun soluzzjoni orali u l-kapsuli rotob tal-ġelatina huma bijoekwivalenti.
English: No special requirements.
Maltese: Sandimmun fit-tqala hi limitata.
English: Other side effects include:
Maltese: Effetti sekondarji rari:
English: The concentrate for solution for infusion contains 50 mg/ml.
Maltese: Il-konċentrat għal soluzzjoni għall-influżjoni fih 50 mg/ml.
English: Sandimmun 50 mg/ml concentrate for solution for infusion ciclosporin
Maltese: Sandimmun 50 mg/ml konċentrat għal soluzzjoni għall-infużjoni ciclosporin
English: For inducing remission, the recommended initial dose is 2.5 mg/kg/day orally given in 2 divided doses.
Maltese: Sabiex ikun hemm remissjoni, id-doża inizjali rrakkomandata hi 2.5 mg/kg/kuljum mogħtija f'2 dożi orali separati.
English: In rheumatoid arthritis clinical trials with ciclosporin, patients aged 65 or older were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥50% above the baseline after 3 to 4 months of therapy.
Maltese: Waqt provi kliniċi f'pazjenti b'artrite rewmatojde, pazjenti li kellhom 65 sena jew aktar kellhom aktar possibbiltà li jiżviluppaw pressjoni għolja sistolika waqt it-terapija, u għandhom aktar possibbiltà li juru żidiet tal-kreatinina tas-serum ta' ≥50% 'il fuq mil-linja bażi wara 3 sa 4 xhur ta' terapija.
English: Leucopenia
Maltese: Lewkopenija
English: • The other ingredients are: o Capsule contents: ethanol anhydrous, maize oil interesterified, maize oil refined.
Maltese: o Il-kontenut tal-kapsula: ethanol anhydrous, maize oil interesterified, maize oil refined.
English: The concentrate for solution for infusion should be diluted 1:20 to 1:100 with normal saline or 5% glucose and given as a slow intravenous infusion over 2 to 6 hours.
Maltese: Il-konċentrat għal soluzzjoni għall-infużjoni għandu jitħallat minn 1:20 sa 1:100 ma' soluzzjoni salina jew ma' 5% glukosju u tingħata bil-mod bħala infużjoni mill-vina fuq medda ta' bejn sagħtejn u 6 sigħat.
English: • Pain in your muscles, muscle spasm.
Maltese: • Uġigħ fil-muskoli tiegħek, spażmi fil-muskoli.
English: Fertility There is limited data on the effect of Sandimmun on human fertility (see section 5.3).
Maltese: Fertilità Teżisti dejta limitata dwar l-effett ta' Sandimmun fuq il-fertilità fost il-bnedmin (ara s-sezzjoni 5.3).
English: The ethanol content of the Sandimmun formulations should also be taken into account in women who are breast-feeding (see section 4.4).
Maltese: Il-kontenut ta' ethanol fil-formulazzjonijiet ta' Sandimmun għandu jitqies ukoll fil-każ ta' nisa tqal (ara s-sezzjoni 4.4).
English: Co-administration of ciclosporin and aliskiren is not recommended (see section 4.3).
Maltese: Mhuwiex irrakkomandat l-għoti flimkien ta' ciclosporin u aliskiren (ara sezzjoni 4.3).
English: • Digoxin (used to treat heart problems), medicines which lower cholesterol (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used to treat cancer), repaglinide (an anti-diabetic medicine), immunosuppressives (everolimus, sirolimus), ambrisentan and specific anti-cancer medicines called anthracyclines (such as doxorubicin).
Maltese: HMG-CoA msejħin ukoll statini), prednisolone, etoposide (użat biex jittratta l-kanċer), repaglinide (mediċina kontra d-dijabete), immunosuppressivi (everolimus, sirolimus), ambrisentan u mediċini speċifikament kontra l-kanċer imsejħin anthracyclines (bħal doxorubicin).
English: Experience with Sandimmun in children with atopic dermatitis is limited.
Maltese: L-esperjenza b'Sandimmun fit-tfal b'dermatite atopika hi limitata.
English: Administration of ciclosporin 3 hours after lercanidipine yielded no change of the lercanidipine AUC, but the ciclosporin AUC was increased by 27%.
Maltese: L-għoti ta' ciclosporin wara 3 sigħat wara lercanidipine ma ġab lebda bidla tal-AUC ta' lercanidipine, imma l-AUC ta' ciclosporin żdied b'27%.
English: Thrombotic microangiopathy, thrombotic thrombocytopenic purpura Metabolism and nutrition disorders
Maltese: Sindrome emolitiku-uremika, anemija emolitika mikroanġjopatika Mikroanġjopatika trombotika, purpura tromboċitopenika trombotika
English: Oral doses of ciclosporin of up to 10 g (about 150 mg/kg) have been tolerated with relatively minor clinical consequences, such as vomiting, drowsiness, headache, tachycardia and in a few patients moderately severe, reversible impairment of renal function.
Maltese: Dożi orali ta' ciclosporin sa 10 g (madwar 150 mg/kg) kienu ttollerati b'konsegwenzi kliniċi relattivament żgħar, bħal rimettar, sturdament, uġigħ ta' ras, takikardija u fi ftit pazjenti indeboliment ftit li xejn gravi imma riversibbli tal-funzjoni tal-kliewi.
English: In 15 renal transplant patients aged 3 -16 years, ciclosporin whole blood clearance after intravenous administration of Sandimmun was 10.6±3.7 ml/min/kg (assay: Cyclo-trac specific RIA).
Maltese: Fi 15-il pazjenti bi trapjant tal-kliewi li għandhom bejn tliet snin u sittax-il sena, it tneħħija ta' ciclosporin mid-demm sħiħ wara l-għoti ta' Sandimmun fil-vina kien ta'10.6±3.7 ml/min/kg (test kimiku: Cyclo-trac speċifiku RIA).
English: Steroid-dependent and steroid-resistant nephrotic syndrome, due to primary glomerular diseases such as minimal change nephropathy, focal and segmental glomerulosclerosis, or membranous glomerulonephritis.
Maltese: Sindromu nefrotiku dipendenti fuq sterojdi u reżistenti għall-isterojdi, minħabba mard glomerulari primarju bħal nefropatija b'bidla minima, glomerulosklerożi fokali u segmentali, jew glomerulonefrite tal-membrana.
English: The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related.
Maltese: Il-karċinomi epatoċellulari u l-adenomi taċ-ċelluli pankreatiċi islet ma kenux relatati mad-doża.
English: • Symptoms of brain disorders including sudden fits, mental confusion, sleeplessness,
Maltese: • Sintomi ta' disturbi fil-moħħ li jinkludu aċċessjonijiet f'daqqa, konfużjoni mentali, nuqqas ta'
English: In the 24-month rat study conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate at the low dose level.
Maltese: Fl-istudju fost il-firien li dam għaddej 24 xahar b'doża ta' 0.5, 2, u 8 mg/kg/kuljum, l-adenoma taċ-ċelloli pankreatiċi islet qabżet b'qawwa r-rata ta' kontroll fil-livell baxx tad-doża.