FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandimmun Neoral 10 mg soft capsules Sandimmun Neoral 25 mg soft capsules Sandimmun Neoral 50 mg soft capsules Sandimmun Neoral 100 mg soft capsules ciclosporin
Maltese: Sandimmun Neoral 10 mg kapsuli rotob Sandimmun Neoral 25 mg kapsuli rotob Sandimmun Neoral 50 mg kapsuli rotob Sandimmun Neoral 100 mg kapsuli rotob ciclosporin
English: Co-administration with telaprevir resulted in approximately 4.64-fold increase in ciclosporin dose normalised exposure (AUC).
Maltese: L-għoti flimkien ta' telaprevir wassal għal żieda ta' mawdar 4.64 fl-espożizzjoni ta' ciclosporin b'doża normalizzata (AUC).
English: Nicardipine, metoclopramide, oral contraceptives, methylprednisolone (high dose), allopurinol, cholic acid and derivatives, protease inhibitors, imatinib, colchicine, nefazodone.
Maltese: Nicardipine,metoclopramide, kontraċettivi orali,methylprednisolone (doża kbira), allopurino, aċidu koliku u derivattivi, inibituri tal-protease, imatinib, colchicine,
English: Sandimmun Neoral suppresses your immune system.
Maltese: Sandimmun Neoral irażżan is-sistema immuni tiegħek.
English: Do not take Sandimmun Neoral:
Maltese: Teħux Sandimmun Neoral:
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
English: Carminic acid (E120) Capsule content Alpha-tocopherol Ethanol anhydrous
Maltese: Il-kitba stampata Carminic acid (E120) Il-kontenut tal-kapsula Alpha-tocopherol
English: A 500 mg dose of Sandimmun Neoral contains 500 mg ethanol, equivalent to nearly 15 ml beer or 5 ml wine.
Maltese: Doża ta' 500 mg Sandimmun Neoral fih 500 mg ethanol , ekwivalenti għal madwar 15 ml birra jew 5 ml nbid.
English: - with products containing Hypericum perforatum (St John´s Wort).
Maltese: Prodotti li fihom Hypericum perforatum (St.
English: For more than 1 ml of medicine, use the 4 ml syringe.
Maltese: - Għal aktar minn ml 1 ta' mediċina, uża seringa ta' 4 ml.
English: Severe rheumatoid arthritis
Maltese: Artrite rewkatojde gravi
English: • Sandimmun Neoral is a different, improved formulation of ciclosporin compared to Sandimmun.
Maltese: • Sandimmun Neoral hu formulazzjoni differenti u mtejba ta' ciclosporin imqabbel ma'
English: Sandimmun Neoral contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients.
Maltese: Sandimmun Neoral fih madwar 12.0 vol. % ethanol (alkoħol), li jikkorrispondi għal 500 mg kull doża użata f'pazjenti bi trapjant.
English: Sandimmun Neoral oral solution should be stored between 15 and 30°C, but preferably not below 20°C for more than 1 month as it contains oily components of natural origin which tend to solidify at low temperatures.
Maltese: Sandimmun Neoral soluzzjoni orali għandha tinħażen f'temperatura ta' bejn 15 u 30°C, imma preferibbilment mhux taħt l-20°C għal aktar minn xahar minħabba li fih komponenti żejtnija ta' oriġini naturali li għandhom tendenza jibbiesu f'temperaturi baxxi.
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 Disturbi tad-demm u tas-sistema limfatika Komuni
English: Sandimmun Neoral contains ethanol
Maltese: Sandimmun Neoral fih l-ethanol.
English: Rheumatoid arthritis Treatment of severe, active rheumatoid arthritis.
Maltese: Trattament ta' artrite rewmatojde gravi u attiva.
English: In addition the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: mhux komuni (≥1/1,000, 1/100); rari (≥1/10,000, < 1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Table 1 Summary of exposure changes of commonly used statins with ciclosporin Statin
Maltese: Tabella 1 Sommarju tat-tibdiliet fl-espożizzjoni ta' statini użati b'mod komuni ma' ciclosporin
English: In the blood, 33 to 47% is present in plasma, 4 to 9% in lymphocytes, 5 to 12% in granulocytes, and 41 to 58% in erythrocytes.
Maltese: Fid-demm, 33 sa 47% jinsab fil-plasma, 4 sa 9% fil-limfoċiti, 5 sa 12%
English: 1 ml oral solution contains 100 mg ciclosporin.
Maltese: ml 1 ta' soluzzjoni orali fiha 100 mg ciclosporin.
English: Each capsule contains 100 mg of the active substance ciclosporin.
Maltese: Kull kapsula fiha 100 mg tas-sustanza attiva ciclosporin.
English: o Capsule shell: Titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
Maltese: Titanium dioxide (E 171), glycerol 85%, propylene glycol, gelatin.
English: {Name of the Member State} {Name of the medicinal product}
Maltese: {Isem tal-Istat Membru} {Isem tal-prodott mediċinali}
English: The recommended dose range is 2.5 to 5 mg/kg/day given in 2 divided oral doses.
Maltese: Il-firxa tad-doża rrakkomandata hi ta' bejn 2.5 u 5 mg/kg/kuljum mogħtija f'2 dożi orali separati.
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: glikoproteina 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: 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: amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole); derivattivi tal-aċdu fibriku (eż. bezafibrate, fenofibrate); NSAIDs (inkluż diclofenac, naproxen, sulindac); melphalan antagonisti tar-riċettur tal-istamina H2 (eż. cimetidine, ranitidine); methotrexate (ara sezzjoni 4.4).
English: • The other ingredients are: DL-alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil mono-di-triglyceride, macrogolglycerol hydroxystearate (Ph.Eur.
Maltese: DL-alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil mono-di-triglyceride, macrogolglycerol hydroxystearate (Ph.Eur.
English: Each mark on the syringe is 0.05 ml.
Maltese: Kull marka fis-seringa hi 0.05 ml.
English: The absolute oral bioavailability of ciclosporin following administration of Sandimmun Neoral is 20 to 50%.
Maltese: Il-bijodisponibbiltà orali assoluta ta' ciclosporin wara l għoti ta' Sandimmun Neoral hi ta' bejn 20 u 50%.
English: Ciclosporin may reduce the clearance of digoxin, colchicine, HMG-CoA reductase inhibitors (statins) and etoposide.
Maltese: Ciclosporin jista' jnaqqas it-tneħħija ta' digoxin, colchicine, inibituri ta' HMG-CoA reductase
English: o Imprint: carminic acid (E 120).
Maltese: o Il-kitba stampata: carminic acid (E 120).
English: Sandimmun Neoral may also cause dose-dependent, reversible increases in serum bilirubin and in liver enzymes (see section 4.8).
Maltese: Epatossiċità Sandimmun Neoral jista' wkoll jikkawża żidiet riversibbli dipendenti fuq id-doża fil-bilirubin tas serum u fl-enzimi tal-fwied (ara sezzjoni 4.8).
English: - Medicines which may increase the level of ciclosporin in your blood include: antibiotics (such as erythromycin or azythromycin), anti-fungals (voriconazole, itraconazole), medicines used for heart problems or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral contraceptives, danazol (used to treat menstrual problems), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukaemia or tumours), colchicine, telaprevir (used to treat hepatitis C).
Maltese: Mediċini li jistgħu jżidu l-livell ta' ciclosporin fid-demm tiegħek jinkludu: antibjotiċi (bħal erythromycin jew azythromycin), antifungali (voriconazole, itraconazole), mediċini użati għal problem tal-qalb jew pressjoni għolja tad-demm (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (użat biex iwaqqaf id-dardir), kontraċettvi orali, danazol (użat biex jittratta problemi menstruwali), mediċini użati biex jikkuraw ilgotta (allopurinol), aċidi koliċi u derivattivi (użati biex jittrattaw il-ġebla), inibituri protease użati biex tkun ittrattata l-HIV, imatinib (użat biex jikkukra l-lewċemija jew ittumuri), colchicine, telaprevir (użat biex jittratta l-epatite Ċ).
English: Thrombotic microangiopathy, thrombotic thrombocytopenic purpura Metabolism and nutrition disorders Very common
Maltese: Mikroanġjopatika trombotika, purpura tromboċitopenika trombotika
English: Sandimmun Neoral 25 mg soft capsules are blue to grey oval and marked with “NVR 25mg” in red.
Maltese: Sandimmun Neoral 25 mg kapsuli rotob huma blu fil-griż ovali, u mmarkati b'“NVR 25 mg” bl aħmar.
English: The formulation of Sandimmun Neoral is a microemulsion preconcentrate.
Maltese: Il-formulazzjoni ta' Sandimmun Neoral hi mikroemulsjoni prekonċentrata.
English: To achieve initial remission, or to counteract inflammatory ocular attacks, systemic corticosteroid treatment with daily doses of 0.2 to 0.6 mg/kg prednisone or an equivalent may be added if Sandimmun Neoral alone does not control the situation sufficiently.
Maltese: jiżdied trattament sistemiku bil-kortikosterojdi b'dożi ta' bejn 0.2 u 0.6 mg/kg prendnisone kuljum jew ekwivalenti jekk Sandimmun Neoral waħdu ma jikkontrollax is-sitwazzjoni b'mod effiċjenti.
English: 1-4 mg
Maltese: L04AD01
English: Atorvastatin 10-80 mg Simvastatin
Maltese: Atorvastatin 10-80 mg Simvastatin 10-80 mg Fluvastatin 20-80 mg Lovastatin 20-40 mg Pravastatin 20-80 mg Rosuvastatin 5-40 mg Pitavastatin 1-4 mg
English: In addition if you are taking Sandimmun Neoral for a non-transplant disease (intermediary or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Sandimmun Neoral:
Maltese: trapjant (uveitis intermedjarja jew posterjuri u uveitis ta' Behçhet, dermatite atopika, artrite rewmatojde gravi jew sindrome nefrotiku), teħux Sandimmun Neoral:
English: Amiodarone substantially increases the plasma ciclosporin concentration concurrently with an increase in serum creatinine.
Maltese: Amiodarone iżid sostanzjalement il-konċentrazzjoni ta' ciclosporin fil-plażma flimkien ma' żieda fil kreatinina tas-serum.
English: Ciclosporin gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up to 17 mg/kg/day and rabbits up to 30 mg/kg/day orally).
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Ciclosporin ma wera l-ebda evidenza ta' effetti mutaġeniċi jew teratoġeniċi f'sistemi ta' testijiet standard b'applikazzjoni orali (il-firien sa 17 mg/kg/kuljum u l-fniek sa 30 mg/kg/kuljum oralment).
English: For 1 ml or less of medicine, use the 1 ml syringe.
Maltese: - Għal ml 1 jew anqas ta' mediċina, uża seringa ta' ml 1.
English: The total dose each day is usually between 5 mg and 7 mg per kilogram body weight.
Maltese: - Id-doża totali għal kuljum hi normalment ta' bejn 5 mg u 7 mg għal kull kilo tal-piż tiegħek.
English: Nausea, vomiting, abdominal discomfort/pain, diarrhoea, gingival hyperplasia, peptic ulcer
Maltese: Dardir, rimettar, skumdità/uġigħ addominali, dijarrea, iperplasija ġenġivali, ulċera peptika
English: Ethanol: 10 mg/capsule.
Maltese: Ethanol: 10 mg/kapsula.
English: Fertility There is limited data on the effect of Sandimmun Neoral on human fertility (see section 5.3).
Maltese: Teżisti dejta limitata dwar l-effett ta' Sandimmun Neoral fuq il-fertilità fost il-bnedmin (ara ssezzjoni 5.3).
English: Propylene glycol: 100 mg/capsule.
Maltese: Propylene glycol: 100 mg/kapsula.
English: Sandimmun Neoral administration results in a 59% higher Cmax and approximately 29% higher bioavailability than Sandimmun.
Maltese: L-għoti ta' Sandimmun Neoral iwassal għal żieda ta' 59% fis-Cmax u ta' 29% fil-bijodisponibbiltà minn Sandimmun.
English: When Sandimmun Neoral is given with other immunosuppressants (e.g. with corticosteroids or as part of a triple or quadruple medicinal product therapy), lower doses (e.g. 3 to 6 mg/kg given in 2 divided doses for the initial treatment) may be used.
Maltese: Meta Sandimmun Neoral jingħata ma' immunosuppressanti oħrajn (eż. ma' kortikosterojdi jew bħala parti minn terapija bi tliet jew erba' prodotti mediċinali), jistgħu jintużaw dożi aktar baxxi (eż. 3 sa 6 mg/kg mogħtija f'żewġ dożi separati għat-trattament inizjali).
English: Pravastatin
Maltese: Sandimmun
English: Other medicines and Sandimmun Neoral
Maltese: Mediċini oħra u Sandimmun Neoral
English: Ciclosporin is an inhibitor of CYP3A4, the multidrug efflux transporter P-glycoprotein and organic anion transporter proteins (OATP) and may increase plasma levels of co-medications that are substrates of this enzyme and/or transporter.
Maltese: Ciclosporin hu inibitur ta' CYP3A4, it-trasportatur tal-efluss tal-multimediċina glikoproteina-P u l proteini trasportaturi tal-anjon organiku (OATP) u jistgħu jgħollu l-livelli tal-plażma meta jingħataw mediċini flimkien li huma sottostrati u/jew trasportaturi ta' din l-enzima.
English: Propylene glycol: 25 mg/capsule.
Maltese: Propylene glycol: 25 mg/kapsula.
English: Renal dysfunction (see section 4.4) Reproductive system and breast disorders Rare
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Rari
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 iċ ciclosporin, jinsabu f'riskju akbar ta' infezzjonijiet (virali, batteriċi, fungali, parasittiċi) (ara sezzjoni 4.4).
English: Imprint
Maltese: TIKKETTAR
English: Capsule shell Iron oxide black (E172) Titanium dioxide (E 171) Glycerol 85% Propylene glycol Gelatin
Maltese: Il-kisja tal-kapsula Iron oxide black (E172) Titanium dioxide (E 171) Glycerol 85% Propylene glycol Gelatin
English: Musculoskeletal and connective tissue disorders Common
Maltese: Raxxijiet allerġiċi Disturbi muskoluskelettriċi u tat-tessuti konnettivi
English: In the 78-week mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.
Maltese: Fi studju fuq il-ġrieden li dam għaddej 78 ġimgħa, b'dożi ta' 1. 4, u 16 mg/kg/kuljum, instab li kien hemm evidenza ta' tendenza sinjifikanti statistikament ta' limfomi limfoċiti fin-nisa, u l-inċidenza ta' karċinomi epatoċellulari fl irġiel mogħtija nofs id-doża qabżet b'qawwa il-valur ta' kontroll.
English: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 101.25 mg/capsule.
Maltese: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 101.25 mg/kapsula.
English: There is only limited experience with the use of Sandimmun Neoral in children with psoriasis.
Maltese: Teżisti esperjenza limitata b'Sandimmun Neoral f'pazjenti anzjani.
English: Capsule shell Iron oxide black (E172) Titanium dioxide (E171) Glycerol 85% Propylene glycol Gelatin
Maltese: Il-kisja tal-kapsula Iron oxide black (E172) Titanium dioxide (E171) Glycerol 85% Propylene glycol Gelatin
English: Ciclosporin trough concentrations in whole blood should be monitored initially within 4 to 7 days after the switch to Sandimmun Neoral.
Maltese: Għall-ewwel, il-konċentrazzjonijiet baxxi ta' ciclosporin fid-demm sħiħ għandha tibqa' tkun immonitorata matul l-4 u 7t ijiem wara l-bidla għal Sandimmun Neoral.
English: 20-80 mg
Maltese: 383.70 mg/ml.
English: Blue-grey, oval soft gelatin capsules, imprinted with “NVR 25mg” in red.
Maltese: Kapsuli rotob tal-ġelatina ovali, blu fil-griż, bil-kitba “NVR 25mg” stampata bl-aħmar.
English: Excipients with known effect:
Maltese: Effetti sekondarji rari ħafna:
English: The total dose each day is usually between 2.5 mg per kilogram of your body weight and 5 mg per kilogram body weight.
Maltese: - Id-doża totali għal kuljum hi normalment ta' bejn 2.5 mg għal kull kilo tal-piż tiegħek u 5 mg għal kull kilo tal-piż tiegħek.
English: Propylene glycol: 10 mg/capsule.
Maltese: Propylene glycol: 10 mg/kapsula.
English: Sandimmun Neoral 100 mg soft capsules are blue to grey oblong and marked with “NVR 100mg” in red.
Maltese: Sandimmun Neoral 100 mg kapsuli rotob huma sofor fl-abjad oblungi, u mmarkati b'“NVR 100 mg”
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: 10.6±3.7 ml/min/kg (test kimiku: Cyclo-trac speċifiku RIA).
English: Each mark on the syringe is 0.1 ml.
Maltese: Kull marka fis-seringa hi 0.1 ml.
English: Capsule shell Titanium dioxide (E 171) Glycerol 85% Propylene glycol Gelatin
Maltese: Il-kisja tal-kapsula Titanium dioxide (E 171) Glycerol 85% Propylene glycol Gelatin
English: Myalgia, muscle cramps
Maltese: Mijalġija, indebboliment muskolari
English: A frequent and potentially serious complication, an increase in serum creatinine and urea, may occur during Sandimmun Neoral therapy.
Maltese: Tossiċità renali Jista' jkun hemm kumplikazzjoni serja frekwenti u potenzjali, jiġifieri żieda fil-kreatinina tas-serum u urea, matul it-terapija b'Sandimmun Neoral.
English: Propylene glycol: 50 mg/capsule.
Maltese: Propylene glycol: 50 mg/kapsula.
English: The terminal half-life ranged from 6.3 hours in healthy volunteers to 20.4 hours in patients with severe liver disease (see sections 4.2 and 4.4).
Maltese: 6.3 sigħat f'voluntiera b'saħħithom u 20.4 sigħat f'pazjenti b'mard serju tal-fwied (ara sezzjonijiet 4.2
English: Experience with Sandimmun Neoral in children with atopic dermatitis is limited.
Maltese: L-esperjenza b'Sandimmun Neoral fit-tfal b'dermatite atopika hi limitata.
English: Sandimmun Neoral 50 mg soft capsules are yellow to white oblong and marked with “NVR 50mg” in red.
Maltese: Sandimmun Neoral 50 mg kapsuli rotob huma sofor fl-abjad oblungi, u mmarkati b'“NVR 50 mg” bl aħmar.
English: Each capsule contains 10 mg ciclosporin.
Maltese: Kull kapsula fiha 10 mg ciclosporin.
English: Sandimmun Neoral and associated names (see Annex I) 10 mg soft capsules Sandimmun Neoral and associated names (see Annex I) 25 mg soft capsules Sandimmun Neoral and associated names (see Annex I) 50 mg soft capsules Sandimmun Neoral and associated names (see Annex I) 100 mg soft capsules
Maltese: Sandimmun Neoral u ismijiet assoċjati (ara Anness I) 10 mg kapsuli rotob Sandimmun Neoral u ismijiet assoċjati (ara Anness I) 25 mg kapsuli rotob Sandimmun Neoral u ismijiet assoċjati (ara Anness I) 50 mg kapsuli rotob Sandimmun Neoral u ismijiet assoċjati (ara Anness I) 100 mg kapsuli rotob
English: Sandimmun Neoral can be given in combination with low-dose corticosteroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.4).
Maltese: Il-frekwenza tat-tumuri malinni tiżdied mal-intensità u ddewmien tat-terapija (ara sezzjoni 4.4).
English: Measuring your dose
Maltese: DATA TA' SKADENZA
English: Capsule shell Titanium dioxide (E171) Glycerol 85% Propylene glycol Gelatin
Maltese: Il-kisja tal-kapsula Titanium dioxide (E171) Glycerol 85% Propylene glycol Gelatin
English: Hirsutism
Maltese: Trapjant
English: Blue-grey, oblong soft gelatin capsules, imprinted with “NVR 100mg” in red.
Maltese: Kapsuli rotob tal-ġelativa oblungi, blu fil-griż, bil-kitba “NVR 100mg” stampata bl-aħmar.
English: Switching from Sandimmun to Sandimmun Neoral
Maltese: Għaliex jintuża Sandimmun Neoral u kif jaħdem Sandimmun Neoral
English: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 202.5 mg/capsule.
Maltese: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 202.5 mg/kapsula.
English: Imprint Carminic acid (E 120)
Maltese: Il-kitba stampata Carminic acid (E 120)
English: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 405.0 mg/capsule.
Maltese: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 405.0 mg/kapsula.
English: • The other ingredients are: o Capsule content: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-monodi-triglycerides, macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor oil.
Maltese: o Il-kontenut tal-kapsula: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oilmono-di-triglycerides, macrogolglycerol hydroxystearate /polyoxyl 40 hydrogenated castor oil. o Il-kisja tal-kapsula:
English: • The other ingredients are: o Capsule contents: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-monodi-triglycerides, macrogolglycerol hydroxystearate /polyoxyl 40 hydrogenated castor oil.
Maltese: o Il-kontenut tal-kapsula: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oilmono-di-triglycerides, macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor oil. o Il-kisja tal-kapsula:
English: About 13 and 33% decrease in AUC and Cmax was observed when Sandimmun Neoral was administered with a high-fat meal.
Maltese: Kien hemm madwar 13 u 33% ta' tnaqqis fl-AUC u s-Cmax meta Sandimmun Neoral ingħata ma' ikla b'livell għoli ta' xaħam.
English: The total dose each day for adults is usually 5 mg per kilogram body weight.
Maltese: - Id-doża sħiħa kuljum għall-adulti hi normalment 5 mg għal kull kilo tal-piż tal-individwu.
English: Skin infections with Staphylococcus aureus are not an absolute contraindication for Sandimmun Neoral therapy, but should be controlled with appropriate antibacterial agents.
Maltese: Infezzjonijiet fil-ġilda b'Staphylococcus aureus mhumiex kontraindikazzjoni assoluta għal terapija b'Sandimmun Neoral, imma għandhom ikunu kkontrollati b'aġenti antibatteriċi xierqa.
English: Yellow-white, oblong soft gelatin capsules, imprinted with “NVR 50mg” in red.
Maltese: Kapsuli rotob tal-ġelatina oblungi, sofor fl-abjad, bil-kitba “NVR 50” stampata bl-aħmar.
English: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 40.5 mg/capsule.
Maltese: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 40.5 mg/kapsula.
English: All metabolites identified so far contain the intact peptide structure of the parent compound; some possess weak immunosuppressive activity (up to one-tenth that of the unchanged drug).
Maltese: Ilmetaboliti kollha identifikati s'issa fihom l-istruttura peptide intatta tal-komponenti parentali; uħud għandhom attività immunosuppressiva dgħajfa (sa wieħed minn kull għaxra tal-mediċina mhux mibdula).
English: Sandimmun Neoral administration improves dose linearity in ciclosporin exposure (AUCB).
Maltese: L-għoti ta' Sandimmun Neoral itejjeb il-linearità tad-doża fl-espożizzjoni ta' ciclosporin (AUCB).
English: Tremor, headache
Maltese: Kif tkejjel id-doża tiegħek
English: • Swelling at the back of the eye which may be associated with an increase in pressure inside the head and eyesight disturbances.
Maltese: * Episodji avversi rrappurtati minn esperjenza wara t-tqegħid tal-prodott fis-suq fejn il-frekwenza tal
English: If there is no alternative, it is recommended to closely monitor blood levels of ciclosporin, renal function, and for side effects of ciclosporin.
Maltese: ciclosporin fid-demm, il-funzjoni tal-kliewi, u l-effetti sekondarji ta' ciclosporin.
English: unconsciousness.
Maltese: Sandimmun.