FrancophonIA/ELRC3.0 huggingface dataset:
English: Pen Needle Parts (Needles Not Included)
Maltese: Partijiet tal-Labra tal-Pinna (Labar Mhux Inklużi)
English: ABASAGLAR comes in a special cartridge to be used only in a Lilly insulin pen.
Maltese: ABASAGLAR huwa fornut fi skartoċċ speċjali li jintuża biss f'pinna tal-insulina Lilly.
English: Pen Cap
Maltese: FEJN MA
English: Solution for injection (injection).
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni).
English: Tell a doctor straight away if you notice signs of severe allergic reaction.
Maltese: Kellem tabib minnufih jekk tinduna b'sinjali ta' reazzjoni allerġika qawwija.
English: Intercurrent illness requires intensified metabolic monitoring.
Maltese: Mard li jitfaċċa minn żmien għall-ieħor jeħtieġ monitoraġġ intensiv tal-metaboliżmu.
English: Switch from twice daily NPH insulin to ABASAGLAR To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.
Maltese: Biex jitnaqqas ir-riskju tal-ipogliċemija matul il-lejl u filgħodu kmieni, il-pazjenti li qed jaqilbu liskeda tal-insulina tal-bażi tagħhom minn insulina NPH ta' darbtejn kuljum, għal skeda ta' darba kuljum b'ABASAGLAR, għandhom inaqqsu d-doża ta' kuljum tal-insulina tal-bażi b'20% sa 30%, waqt l-ewwel ġimgħat tat-trattament.
English: In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Maltese: Fi studji kliniċi l-analiżi ta' sottogruppi ibbażati fuq l-età u s-sess, ma indikaw l-ebda differenza fissigurtà u l-effikaċja f'pazjenti kkurati b'insulin glargine meta tqabblu mal-popolazzjoni kollha talistudju.
English: The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen (see section 4.4).
Maltese: - li qed jieħdu t-trattament flimkien ma' ċerti prodotti mediċinali oħra (ara sezzjoni 4.5).
English: There were no differences between insulin glargine and standard care for the two coprimary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Maltese: Ma kien hemm l-ebda differenza bejn insulin glargine u l-kura standard għaż-żewġ lottijiet ta' riżultati primarji; għal kwalunkwe komponent tal-għan finali li jagħmel parti minn dawn ir-riżultati; għall-mewt minn kwalunkwe kawża; jew għar-riżultat kompost mikrovaskulari.
English: In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Maltese: F'pazjenti li għandhom retinopatija proliferattiva, speċjalment meta ma tkunx ittrattata b'fotokoagulazzjoni, episodji ta' ipogliċemija severa jistgħu jwasslu għal amawrosi temporanja.
English: This medicinal product must not be mixed with other medicinal products.
Maltese: - trattament fl-istess waqt ma' xi prodotti mediċinali oħra.
English: See the box at the end of this leaflet for further information.
Maltese: Ara l-kaxxa fl-aħħar ta' dan il-fuljett għal aktar informazzjoni.
English: In-use cartridges
Maltese: Tieqa tadDoża
English: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal.
Maltese: (n=349) li kienu magħżula b'mod każwali ġew ikkurati għal 28 ġimgħa bi skeda ta' insulina tal-bażi mogħtija f'daqqa fejn insulina umana regolari intużat qabel kull ikla.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Maltese: +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
English: 16 January 2014 EMA/35464/2014
Maltese: EMA/35464/2014
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Ikkuntattja lill-uffiċjali tal-istampa tagħna Monika Benstetter jew Martin Harvey
English: Not yet known1
Maltese: Għadu mhux magħruf1
English: With the exception of Zoely (nomegestrol acetate/estradiol), Ioa (nomegestrol acetate/estradiol) and Evra (norelgestromin/ethinylestradiol), which have been authorised centrally through the EMA, all other combined contraceptives in the EU have been authorised via national procedures.
Maltese: Bl-eċċezzjoni ta' Zoely (nomegestrol acetate/estradiol), Ioa (nomegestrol acetate/estradiol) u Evra (norelgestromin/ethinylestradiol), li ġew awtorizzati ċentralment permezz tal-EMA, il-kontraċettivi kollha l-oħra kkombinati fl-UE ġew awtorizzati permezz ta' proċeduri nazzjonali.
English: The review included all contraceptives containing low-dose oestrogen and the following progestogens: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin and norgestimate.
Maltese: Ir-reviżjoni kienet tinkludi l-kontraċettivi kollha li fihom estroġenu f'doża baxxa u l-proġestoġeni li ġejjin: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin u norgestimate.
English: • The EU-wide review of combined hormonal contraceptives (CHCs) has confirmed that the known risk of venous thromboembolism (VTE) with all low-dose CHCs (ethinylestradiol < 50 mcg) is small.
Maltese: • Ir-reviżjoni madwar l-UE kollha ta' kontraċettivi ormonali kkombinati (CHCs) ikkonfermat li r-riskju magħruf ta' tromboemboliżmu arterjali (VTE) bis-CHCs kollha f'doża baxxa (ethinylestradiol < 50 mcg) huwa żgħir.
English: CHCs contain two types of hormones, an oestrogen and a progestogen.
Maltese: CHCs fihom żewġ tipi ta' ormoni, estroġenu u proġestoġen.
English: The review of combined hormonal contraceptives was initiated in February 2013 at the request of France, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' kontraċettivi ormonali kkombinati nbdiet fi Frar 2013 fuq talba ta' Franza, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: • It is also important to raise awareness of the signs and symptoms of VTE and ATE when prescribing a CHC.
Maltese: • Huwa wkoll importanti li titqajjem kuxjenza dwar is-sinjali u s-sintomi ta' VTE u ATE meta jiġi preskritt CHC.
English: • When prescribing a CHC, careful consideration should be given to the individual woman's current risk factors, particularly those for VTE, and the difference in risk of VTE between products.
Maltese: • Meta ssir preskrizzjoni ta' CHC, għandha tingħata konsiderazzjoni bir-reqqa lill-fatturi ta' riskju attwali tal-mara individwali, b'mod partikolari dawk għal VTE, u d-differenza fir-riskju ta' VTE bejn il-prodotti.
English: • Differences exist between CHCs in their risk of VTE depending on the type of progestogen they contain.
Maltese: • Jeżistu differenzi bejn CHCs fir-riskju tagħhom ta' VTE skont it-tip ta' proġestoġen li fihom.
English: • When taking CHCs, you should be alert for the signs and symptoms of blood clots, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arm or leg.
Maltese: • Meta tkun qed tieħu CHCs, għandek toqgħod attenta għas-sinjali u s-sintomi ta' emboli tad-demm, li jistgħu jinkludu uġigħ qawwi jew nefħa fir-riġlejn, qtugħ ta' nifs f'daqqa u mingħajr spjegazzjoni, nifs mgħaġġel jew sogħla, uġigħ fis-sider, u dgħjufija jew titrix tal-wiċċ, ta' driegħ jew ta' riġel.
English: • There is no evidence for differences between low-dose CHCs in their risk of arterial thromboembolism (ATE).
Maltese: • Ma hemm l-ebda evidenza għal differenzi bejn CHCs b'doża baxxa fir-riskju tagħhom ta' tromboemboliżmu arterjali (ATE).
English: Currently available data indicate that CHCs containing the progestogens levonorgestrel, norethisterone or norgestimate have the lowest risk of VTE (see table below).
Maltese: Dejta attwalment disponibbli tindika li CHCs li fihom il-proġestoġeni levonorgestrel, norethisterone jew norgestimate għandhom l-aktar riskju baxx ta' VTE (ara t-tabella hawn taħt).
English: • The risk of blood clots in the veins varies between CHCs, depending on the type of progestogen (a hormone) they contain, and ranges from 5 to 12 cases of blood clots per 10,000 women who use them for a year (see table below).
Maltese: • Ir-riskju ta' emboli tad-demm fil-vini jvarja bejn CHCs, skont it-tip ta' proġestoġen (ormon) li jkun fihom, u jvarja minn 5 sa 12-il każ ta' emboli tad-demm għal kull 10,000 mara li tużahom fis-sena (ara t-tabella hawn taħt).
English: On 21 November 2013, the European Medicines Agency completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use.
Maltese: Fil-21 ta' Novembru 2013, l-Aġenzija Ewropea għall-Mediċini temmet ir-reviżjoni tagħha ta' kontraċettivi ormonali kkombinati (CHCs), b'mod partikolari r-riskju ta' tromboemboliżmu venuż (VTE jew emboli tad-demm fil-vini) assoċjat mal-użu tagħhom.
English: Risk factors include being very overweight, increasing age, having a member of your family who has had a blood clot at a relatively young age (e.g. below 50), having migraine or being immobilised for a long time (e.g. because of an illness or injury).
Maltese: Fatturi ta' riskju jinkludu piż żejjed ħafna, żieda fl-età, li jkollok membru tal-familja li kellu embolu tad-demm f'età relattivament żgħira (eż. taħt il-50), li jkollok emigranja jew tkun immobilizzata għal żmien twil (eż. minħabba mard jew korriment ).
English: It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive.
Maltese: Huwa importanti li n-nisa jiġu magħmula konxji tar-riskju ta' VTE u s-sinjali u s-sintomi tiegħu, u li t-tobba jqisu l-fatturi ta' riskju individwali tal-mara meta jippreskrivu kontraċettiv.
English: The review also looked at the risk of arterial thromboembolism (ATE, blood clots in arteries, which can potentially cause a stroke or heart attack).
Maltese: Ir-reviżjoni ħarset ukoll lejn ir-riskju ta' tromboemboliżmu arterjali (ATE, emboli tad-demm fl-arterji, li potenzjalment jistgħu jikkawżaw puplesija jew attakk tal-qalb).
English: • If you have been taking CHCs without any problem, there is no reason for you to stop taking them on the basis of this review.
Maltese: • Jekk kont qed tieħu CHCs mingħajr ebda problema, m'hemm l-ebda raġuni għaliex għandek tieqaf teħodhom abbażi ta' din ir-reviżjoni.
English: The CHMP opinion, in agreement with the previous recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), was sent to the European Commission, which adopted on 16 January 2014 a legally binding decision to update the product information of all CHCs throughout the EU.
Maltese: L-opinjoni tas-CHMP, fi qbil mar-rakkomandazzjoni preċedenti mill-Kumitat dwar il-Valutazzjoni tarRiskji tal-Farmakoviġilanza (PRAC), intbagħtet lill-Kummissjoni Ewropea, li fis-16 ta' Jannar 2014 adottat deċiżjoni legalment vinkolanti biex l-informazzjoni dwar il-prodott tas-CHCs kollha tiġi aġġornata madwar l-UE.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għallmistoqsijiet kollha dwar mediċini għall-użu mill-bniedem, li adotta l-opinjoni finali tal-Aġenzija.
English: • You should discuss with your doctor or nurse what is the most appropriate type of contraception for you.
Maltese: • Għandek tiddiskuti mat-tabib jew mal-infermier tiegħek liema hija l-aktar tip ta' kontraċezzjoni xierqa għalik.
English: During the review, the risk of VTE with these medicines was compared with that of CHCs containing levonorgestrel and norethisterone (also known as ‘second generation' contraceptives).
Maltese: Matul ir-reviżjoni, ir-riskju ta' VTE b'dawn il-mediċini ġie mqabbel ma' dak ta' CHCs li fihom levonorgestrel u norethisterone (magħrufa wkoll bħala kontraċettivi tat-‘tieni ġenerazzjoni').
English: Women using a CHC containing chlormadinone, dienogest or nomegestrol
Maltese: Nisa li jkunu qed jużaw CHC li fih chlormadinone, dienogest jew nomegestrol
English: But it is important that you are aware of the risk of blood clots associated with these medicines, even though it is very low.
Maltese: Iżda huwa importanti li tkun konxja mir-riskju ta' emboli taddemm assoċjati ma' dawn il-mediċini, anki jekk huwa baxx ħafna.
English: The classification as ‘second, third or fourth generation' is however not science-based and not standardised, and may differ between institutions and publications.
Maltese: Madankollu l-klassifika bħala ‘t-tieni, it-tielet jew ir-raba' ġenerazzjoni' mhijiex ibbażata fuq ix-xjenza u mhijiex standardizzata, u tista' tvarja bejn istituzzjonijiet u pubblikazzjonijiet.
English: Women using a CHC containing levonorgestrel, norethisterone or norgestimate
Maltese: Nisa li jkunu qed jużaw CHC li fih levonorgestrel, norethisterone jew norgestimate
English: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu millBniedem (CHMP) tal-Aġenzija Ewropea għall-Mediċini kkonkluda li l-benefiċċji ta' CHCs fil-prevenzjoni ta' tqaliet mhux mixtieqa jkomplu jegħlbu r-riskji tagħhom, u li r-riskju magħruf sew ta' VTE bis-CHCs kollha huwa żgħir.
English: This compares with 2 cases of blood clots in the veins each year per 10,000 women who are not using CHCs.
Maltese: Dan jikkompara ma' żewġ każijiet ta' emboli tad-demm fil-vini fis-sena għal kull 10,000 mara li ma tkunx qed tuża CHCs.
English: Risk of developing a blood clot (VTE) in a year Women not using a combined hormonal pill/patch/ring and are not pregnant
Maltese: Riskju għall-iżvilupp ta' embolu tad-demm (VTE) f'sena Nisa li ma jkunux qed jużaw pillola/garża/ċirku ormonali kkombinati u li mhumiex tqal
English: • Healthcare professionals should always consider the possibility of a CHC-associated thromboembolism when presented with a woman who has symptoms.
Maltese: • Il-professjonisti tal-kura tas-saħħa għandhom dejjem iqisu l-possibbiltà ta' tromboemboliżmu marbut ma' CHC meta jiġu ppreżentati b'mara li jkollha s-sintomi.
English: • In adults:
Maltese: • Fl-adulti:
English: • Store at room temperature (15°C to 30°C).
Maltese: • Aħżen f'temperatura tal-kamra (15°C sa 30°C).
English: Hepatic function abnormal (see section 4.4)
Maltese: Funzjoni epatika anormali (ara sezzjoni 4.4)
English: Renal toxicity
Maltese: Tossiċità renali
English: Atorvastatin 10-80 mg Simvastatin 10-80 mg Fluvastatin 20-80 mg Lovastatin
Maltese: Atorvastatin 10-80 mg Simvastatin
English: Not known*
Maltese: Mhux magħruf*
English: Subsequent use Commence at point 5.
Maltese: Użu sussegwenti Ibda minn punt 5.
English: Pravastatin 20-80 mg Rosuvastatin 5-40 mg Pitavastatin 1-4 mg
Maltese: Rosuvastatin 5-40 mg 1-4 mg
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% fil-granuloċiti, u 41 sa 58% fl-eritroċiti.
English: Convulsions, paraesthesia
Maltese: Konvulżjonijiet, parestesija
English: {e-mail}
Maltese: {fax} {e-mail}
English: Nephrotic syndrome
Maltese: Sindromu nefrotiku
English: • The active substance is ciclosporin.
Maltese: • Is-sustanza attiva hi ciclosporin.
English: Barbiturates, carbamazepine, oxcarbazepine, phenytoin; nafcillin, intravenous sulfadimidine, probucol, orlistat, hypericum perforatum (St. John's wort), ticlopidine, sulfinpyrazone, terbinafine, bosentan.
Maltese: Barbiturates, carbamazepine, oxcarbazepine, phenytoin; nafcillin, sulfadimidine fil-vini, probucol, orlistat, hypericum perforatum (St. John's wort), ticlopidine, sulfinpyrazone, terbinafine, bosentan.
English: Medical supervision
Maltese: Superviżjoni medika
English: A 100 mg dose of Sandimmun contains 556 mg ethanol.
Maltese: Doża ta' 100 mg Sandimmun fiha 556 mg ethanol.
English: Sandimmun contains around 12% vol. ethanol.
Maltese: Sandimmun fih madwar 12% vol. ethanol.
English: Sandimmun soft capsules contain 12.8% v/v ethanol (10.2% m/v).
Maltese: Sandimmun kapsuli rotob fihom 12.8% v/v ethanol (10.2% m/v).
English: The inter- and intrasubject variability ranges between 18 to 74%.
Maltese: Il-meded ta' varjabbiltà inter- u intrasuġġettali huma ta' bejn 18 u 74%.
English: Sandimmun 100 mg/ml oral solution ciclosporin
Maltese: Sandimmun 100 mg/ml soluzzjoni orali ciclosporin
English: Everolimus and sirolimus had only a minor influence on ciclosporin pharmacokinetics.
Maltese: Everolimus u sirolimus kellhom biss influwenza minima fuq il-farmakokinetiċi ta' ciclosporin.
English: Gastrointestinal disorders Common
Maltese: Disturbi gastrointestinali Komuni
English: Sandimmun oral solution contains 12.6% v/v ethanol (10.0% m/v ethanol).
Maltese: Sandimmun soluzzjoni orali fiha 12.6% v/v ethanol (10.0% m/v ethanol).
English: Thrombocytopenia, anaemia
Maltese: Tromboċitopenija, anemija
English: Sandimmun contains ethanol
Maltese: Sandimmun contains sorbitol
English: Sandimmun 25 mg soft capsules Sandimmun 50 mg soft capsules Sandimmun 100 mg soft capsules ciclosporin
Maltese: Sandimmun 25 mg kapsuli rotob Sandimmun 50 mg kapsuli rotob Sandimmun 100 mg kapsuli rotob ciclosporin
English: The oral LD50 of ciclosporin is 2,329 mg/kg in mice, 1,480 mg/kg in rats and > 1,000 mg/kg in rabbits.
Maltese: L-LD50 orali ta' ciclosporin hu ta' 2,329 mg/kg fil-ġrieden, 1,480 mg/kg fil-firien u >1,000 mg/kg filfniek.
English: Sandimmun 50 mg/ml concentrate for solution for infusion contains around 34% v/v ethanol (27.8% m/v ethanol).
Maltese: Sandimmun 50 mg/ml konċentrat għal soluzzjoni għall-infużjoni fih madwar 34% v/v ethanol (27.8% m/v ethanol).
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: 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: 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 (statini) u etoposide.
English: It contains the active substance ciclosporin.
Maltese: Fih is-sustanza attiva ciclosporin.
English: The recommended intravenous dose is 3 to 5 mg/kg/day.
Maltese: Id-doża fil-vina rrakkomandata hi ta' bejn 3 u 5 mg/kg/kuljum.
English: • if you have epilepsy.
Maltese: • jekk tbati minn epilessija.
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: Clinical studies have included children from 1 year of age using standard ciclosporin dosage with a comparable safety profile to adults.
Maltese: Studji kliniċi inkludew tfal minn sena li jużaw doża standard ta' ciclosporin bi profil ta' sigurtà komparabbli għall-adulti.
English: In plasma, approximately 90% is bound to proteins, mostly lipoproteins.
Maltese: Fil-plasma, madwar 90% jeħel mal-proteini, l-aktar mallipoproteini.
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, nefazodone.
English: Macrogolglycerol ricinoleate/polyethoxylated castor oil
Maltese: Ethanol anhydrous Macrogolglycerol ricinoleate/polyethoxylated castor oil
English: Hyperglycaemia, anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia Nervous system disorders
Maltese: Ipergliċemija, anoressija, iperurikemija, iperkalemija, ipomagneżemija
English: Ciclosporin was tested in a number of in vitro and in vivo tests for genotoxicity with no evidence for a clincally relevant mutagenic potential.
Maltese: Ciclosporin kien ittestjat waqt numru ta' testijiet in vitro u in vivo dwar il-ġenotossiċità mingħajr ma ntwera li kien hemm potenzjal mutaġeniku relevanti klinikament.
English: Atopic dermatitis Sandimmun is indicated in patients with severe atopic dermatitis when systemic therapy is required.
Maltese: Dermatite atopika Sandimmun hu indikat għal pazjenti b'dermatite atopika gravi meta tenħtieġa terapija sistemika.
English: Pink, oval soft gelatin capsules Corn yellow, oblong soft gelatin capsules Dusty rose, oblong soft gelatin capsules
Maltese: Roża, kapsuli rotob tal-ġelatina ovali Sofor lewn il-qamħ, kapsuli rotob tal-ġelatina oblungi Roża mutrab, kapsuli rotob tal-ġelatina oblungi
English: Sandimmun contains castor oil and ethanol
Maltese: Sandimmun fih castor oil u ethanol
English: Pyrexia, fatigue
Maltese: Piressija, għeja
English: Azitromycin increases ciclosporin levels by around 20%.
Maltese: Azitromycin iżid il-livelli ta' ciclosporin b'madwar 20%.
English: Rheumatoid arthritis Treatment of severe, active rheumatoid arthritis.
Maltese: Artrite rewmatojde Trattament ta' artrite rewmatojde gravi u attiva.
English: Ciclosporin is an inhibitor of CYP3A4, the multidrug efflux transporter P-glycoprotein (P-gp) and organic anion transporter proteins (OATP).
Maltese: Ciclosporin hu inibitur ta' CYP3A4, it-trasportatur tal-efluss tal-multimediċina glikoproteina-P (P-gp) u l-proteini trasportaturi tal-anjon organiku (OATP).
English: Experience with acute overdosage of ciclosporin is limited.
Maltese: L-esperjenza b'doża eċċessiva akuta ta' ciclosporin hi limitata.
English: Sandimmun suppresses your immune system.
Maltese: Sandimmun irażżan is-sistema immuni tiegħek.
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Komuni
English: Combination with products containing Hypericum perforatum (St John´s Wort) (see section 4.5).
Maltese: L-użu flimkien ma' prodotti li fihom Hypericum perforatum (St. John's Wort) (ara sezzjoni 4.5).
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: Azole antibiotics: Ketoconazole, fluconazole, itraconazole and voriconazole could more than double ciclosporin exposure.
Maltese: Ketoconazole, fluconazole, itraconazole u voriconazole jistgħu aktar milli jirduppjaw l-espożizzjoni ta' ciclosporin.
English: Transplantation Solid organ transplantation
Maltese: Trapjant ta' organu solidu
English: Acute and chronic nephrotoxicity
Maltese: Nefrotossiċità akuta u kronika
English: Clarithromycin has been reported to double the exposure of ciclosporin.
Maltese: Clarithromycin kien irrappurtat li jirdoppja l-espożizzjoni ta' ciclosporin.
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
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina tissejjes fuq il-konvenzjoni li ġejja (CIOMS III): komuni ħafna (≥1/10); komuni (≥1/100, <1/10); 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: Prevention of graft rejection following solid organ transplantation.
Maltese: Prevenzjoni ta' riġettar tat-trapjant wara trapjanti alloġeniċi ta' organi solidi.