FrancophonIA/ELRC3.0 huggingface dataset:
English: Zonegran must not be used in people who are hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Maltese: Zonegran ma għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għal zonisamide, kwalunkwe mill-ingredjenti l-oħra, jew għas-sulfonamidi (bħal xi antibijotiċi).
English: What is the risk associated with Zonegran?
Maltese: Għal xiex jintuża Zonegran?
English: When Zonegran is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Maltese: Meta Zonegran jintuża bħala żieda għat-trattament eżistenti, id-doża inizjali fl-adulti rakkomandata hija 25 mg darbtejn kuljum.
English: How is Zonegran used?
Maltese: Kif jintuża Zonegran?
English: When Zonegran is used as an ‘add-on' to existing treatment in children aged 6 years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Maltese: Meta Zonegran jintuża bħala trattament ta' żieda ma' trattament eżistenti fit-tfal minn sitt snin ‘il fuq, id-doża tiddependi fuq il-piż tal-ġisem; id-doża rakkomandata tal-bidu hija 1mg għal kull kilo piż talġisem kuljum.
English: When Zonegran is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Maltese: Meta Zonegran jintuża waħdu f'pazjenti li jkunu għadhom kemm ingħataw dijanjożi, id-doża tal-bidu rakkomandata hija 100 mg darba kuljum għal ġimagħtejn, li tista' tiżdied b'100 mg f'intervalli ta' ġimagħtejn.
English: What is Zonegran?
Maltese: X'inhu Zonegran?
English: For the full list of all side effects reported with Zonegran, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zonegran, ara l-fuljett ta' tagħrif.
English: This reduces the chances of an epileptic fit. Zonegran also acts on the neurotransmitter gamma-aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Maltese: Zonegran jaġixxi wkoll fuq in-newrotrażmettitur gamma aċidu -aminobutriku (GABA, kimika li tippermetti liċ-ċelloli tannervituri jikkomunikaw ma' xulxin).
English: It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged 6 years and above already receiving other antiepilepsy medicines.
Maltese: Jintuża f'adulti li għadhom kemm ingħataw dijanjożi u bħala żieda għat-terapija fl-adulti u t-tfal li għandhom minn sitt snin ‘il fuq li diġà qed jieħdu mediċini oħra kontra l-epilessija.
English: Zonisamide works by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels.
Maltese: Iz-zonisammid jaħdem billi jimblokka pori speċifiċi fuq issuperfiċje taċ-ċelloli tan-nervituri magħrufa bħala kanali tas-sodju u tal-kalċju.
English: Strength Pharmaceutical Form
Maltese: Għamla farmacewtika
English: 17 November 2011
Maltese: 17 ta' Novembru 2011
English: They are available as gastroresistant capsules.
Maltese: Jiġu bħala kapsuli gastroreżistenti.
English: The full European Public Assessment Report for Ariclaim, Cymbalta and Xeristar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Ir-Rapport ta' Valutazzjoni Pubblika Ewropew għal Ariclaim, Cymbalta u Xeristar jista' jinstab fis-sit elettoniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Ariclaim, Cymbalta and Xeristar are medicines containing the active substance duloxetine.
Maltese: Ariclaim, Cymbalta u Xeristar huma mediċini li fihom is-sustanza attiva duloxetine.
English: What are Ariclaim, Cymbalta and Xeristar?
Maltese: X'inhuma Ariclaim, Cymbalta u Xeristar?
English: How are they expected to work?
Maltese: Kif inhuma mistennija li jaħdmu?
English: After considering the grounds for this request, the CHMP re examined the initial opinion, and confirmed the refusal of the change to the marketing authorisations on 17 November 2011.
Maltese: Wara li kkunsidra r-raġunijiet għal din ittalba, is-CHMP eżamina mill-ġdid l-opinjoni inizjali u kkonferma r-rifjut tal-bilda għallawtorizzazzjonijiet għat-tqegħid fis-suq fis-17 ta' Novembru 2011.
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Maltese: Fil-21 ta' Lulju 2011, il-Kumitat għall-Prodotti Meċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut ta' bidla għall-awtorizzazzjonijiet għat-tqegħid fis-suq għall-mediċini li fihom duloxetine, jiġifieri Ariclaim, Cymbalta u Xeristar.
English: Somatic pain is from the body surfaces (such as skin) or musculoskeletal tissues (such as skeletal muscles, bone and joints).
Maltese: Uġigħ somatiku huwa mill-uċuh talġisem (bħall-ġilda) jew tessuti muskuloskeletali (bħal muskoli skeletali, għadam u ġogi).
English: The active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Issustanza attiva duloxetine, hija inibitur ta' teħid mill-ġdid ta' serotonin-noradrenaline.
English: The company that applied for the change to the authorisation is Eli Lilly.
Maltese: Il-kumpanija li applikat għall-bidla għall-awtorizzazzjoni hija Eli Lilly.
English: It does not include pain from internal organs such as the stomach and intestines.
Maltese: Ma jinkludix uġigħ minn organi interni bħall-istonku u intestini.
English: The CHMP noted that the studies had not proven that duloxetine would provide a relevant benefit in the indication applied for.
Maltese: Is-CHMP innota li l-istudji ma tawx prova li duloxetine jipprovdi benefiċċju relevanti fl-indikazzjoni li saret applikazzjoni għaliha.
English: It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Taħdem billi timpedixxi lin-newrotrasmettituri 5-hydroxytrypamine (imsejjaħ ukoll serotonin) u noradrenaline milli jittieħdu mill-ġdid fiċ-ċelloli tan-nervituri fil-moħħ u fil-korda spinali.
English: The company informed the CHMP that there are currently no ongoing clinical trials with Ariclaim, Cymbalta and Xeristar in chronic somatic pain patients in Europe.
Maltese: Il-kumpanija infurmat lis-CHMP li fil-preżent ma hemm ebda prova klinika għaddejja b'Ariclaim, Cymbalta u Xeristar f'pazjenti b'uġigħ somatiku kroniku fl-Ewropa.
English: In addition to pain due to diabetic peripheral neuropathy, Cymbalta and Xeristar are also used in major depression and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: Barra mill-uġigħ dovut għal newropatija periferali dijabteika, Cymbalta u Xeristar jintużaw ukoll f'dipressjoni maġġuri u f'disturb ġeneralizzat tal-ansjetà (ansjetà jew nervożiżmu fit-tul dwar affarijiet ta' kuljum).
English: The CHMP therefore concluded that the benefits of duloxetine in the treatment of moderate to severe chronic somatic pain in patients not regularly taking NSAIDs had not been shown to outweigh its risks.
Maltese: Għaldaqstant, is-CHMP ikkonkluda li l-benefiċċji ta' duloxetine fil-kura ta' uġigħ somatiku kroniku sever f'pazjenti li ma kinux qegħdin jieħdu NSAIDs b'mod regolari ma ntwerewx li jisbqu r-riskji tiegħu.
English: The company presented results of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in patients with chronic low back pain.
Maltese: Il-kumpanija ppreżentat riżultati minn ħames studji ewlenin fi 839 pazjent b'uġigħ somatiku kroniku: żewġ studji f'pazjenti b'uġigħ fl-irkoppa kkawżat minn osteoartrite (nefħa u uġigħ fil-ġogi) u tlieta f'pazjenti b'uġigħ kroniku fil-parti t'isfel tad-dahar.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Maltese: Ariclaim jintuża biex jikkura uġigħ dovut għal newropatija periferali (ħsara lin-nervituri fl-estremitajiet li tista' sseħħ f'pazjenti bid-dijabete).
English: During the re-examination, the Committee considered the use of duloxetine in a smaller group of patients: patients with chronic low back pain or osteoarthritis (swelling and pain in the joints) of at least moderate severity who cannot use NSAIDS.
Maltese: Matul eżaminazzjoni mill-ġdid, il-Kumitat ikkunsidra l-użu ta' duloxetine fi grupp iżgħar ta' pazjenti: pazjenti b'uġigħ kroniku fil-parti ta' isfel tad-dahar jew osteoartrite (nefħa u uġigħ fil-ġogi) ta' għallinqas severità moderata li ma jistgħux jużaw NSAIDs. Madankollu, il-Kumitat ikkonkluda li ttħassib tiegħu ma ġiex indirizzat b'mod adegwat u kkonferma l-opinjoni negattiva inizjali tiegħu li tirrakkomanda bidla fl-awtorizzazzjonijiet għat-tqegħid fis-suq.
English: The medicines are expected to work in the same way they do in diabetic peripheral neuropathy.
Maltese: Il-mediċini huma mistennija li jaħdmu bl-istess mod li jaħdmu f'newropatija periferali dijabetika.
English: What did the company present to support its application?
Maltese: X'inhu t-tħassib ewlieni tas-CHMP li wassal għar-rifjut tal-bidla għallawtorizzazzjonijiet għat-tqegħid fis-suq?
English: What is happening with Ariclaim, Cymbalta and Xeristar for in their approved indications?
Maltese: X'inhu jiġri b'Ariclaim, Cymbalta u Xeristar fl-indikazzjonijiet approvati tagħhom?
English: In addition, more information was needed on the effects of duloxetine in elderly patients and its safety in the intended patients including the elderly.
Maltese: Barra minn hekk, kien hemm bżonn ta' aktar informazzjoni fuq l-effetti ta' duloxetine f'pazjenti anzjani u dwar is-sigurtà tiegħu fil-pazjenti filmira inkluż l-anzjani.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Maltese: In-newrotrasmettituri huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri sabiex jikkomunikaw ma' xulxin.
English: The main measure of effectiveness was the change in the severity of pain, as recorded by the patients on an 11-point scale after 12 or 13 weeks of treatment.
Maltese: Il-miżura ewlenia taleffikaċja kienet il-bidla fis-severità tal-uġigħ, irreġistrata mill-pazjenti fuq skala ta' 11-il punt wara 12 jew 13-il ġimgħa ta' kura.
English: MA (EU) number (Invented) name
Maltese: Numru ta l-MA EU Isem (ivvintat) Qawwa
English: The full EPAR for Vizarsin 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.
English: Vizarsin is a ‘generic medicine'.
Maltese: Vizarsin huwa ‘mediċina ġenerika'.
English: It is available as film-coated tablets (25, 50 and 100 mg) and as orodispersible tablets (25, 50 and 100 mg).
Maltese: Jiġi f'pilloli miksijin b'rita (25, 50 u 100 mg) u f'pilloli orodispersibbli (25, 50 and 100 mg).
English: The active ingredient in Vizarsin, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Is-sustanza attiva f'Vizarsin, is-sildenafil, tappartieni lil grupp ta' mediċini msejjaħ inibituri talfosfodjesterażi tat-tip 5 (PDE5).
English: Vizarsin is a medicine that contains the active substance sildenafil.
Maltese: Vizarsin huwa mediċina li fiha s-sustanza attiva sildenafil.
English: This is a summary of the European public assessment report (EPAR) for Vizarsin.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Vizarsin.
English: The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Maltese: Id-doża tista' tiżdied sa massimu ta' 100 mg jew titnaqqas għal 25 mg skont l-effikaċja u l-effetti sekondarji.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Maltese: Waqt stimulazzjoni sesswali normali, fil-pene tiġi prodotta s-cGMP u tikkawża r-rilassament fil-korpora kavernoża (muskolu fittessut tal-pene li qisu sponża).
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Maltese: Din taħdem billi timblokka l-enzima fosfodjesterażi, li normalment tkisser sustanza magħrufa bħala gwanożin monofosfat ċikliku (cGMP).
English: Because Vizarsin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Maltese: Billi Vizarsin huwa mediċina ġenerika, l-istudji ġew limitati għal testijiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Viagra.
English: The CHMP concluded that, in accordance with EU requirements, Vizarsin has been shown to have comparable quality and to be bioequivalent to Viagra.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Vizarsin għandu kwalità kumparabbli u li huwa bijoekwivalenti għal Viagra.
English: Why has Vizarsin been approved?
Maltese: Għaliex ġie approvat Vizarsin?
English: This means that Vizarsin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Maltese: Dan ifisser li Vizarsin huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Viagra.
English: What is Vizarsin?
Maltese: X'inhu Vizarsin?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vizarsin on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq lil Vizarsin valida fl-Unjoni Ewropea kollha fl-21 ta' Settembru 2009.
English: Patients with reduced liver or severely reduced kidney function should start treatment with the 25 mg dose.
Maltese: Il-pazjenti li jkollhom tnaqqis fil-funzjoni tal-fwied jew tnaqqis gravi fil-funzjoni tal-kliewi għadhom jibdew it-trattament b'25 mg.
English: The recommended dose of Vizarsin is 50 mg taken as needed about one hour before sexual activity.
Maltese: Id-doża rakkomandata ta' Vizarsin hija 50 mg meħuda madwar siegħa qabel l-attività sesswali.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu listess livelli tas-sustanza attiva fil-ġisem.
English: Because Vizarsin is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Minħabba li Vizarsin huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, jitqies li lbenefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Vizarsin is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Maltese: Vizarsin jintuża fit-trattament ta' rġiel b'disfunzjoni erettili (xi drabi tissejjaħ impotenza), meta ma jkunx jista' jkollhom jew ma jkunux jistgħu jżommu l-pene iebes (erezzjoni) għal attività sesswali sodisfaċenti.
English: What are the benefits and risks of Vizarsin?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Vizarsin?
English: How does Vizarsin work?
Maltese: Għal xiex jintuża Vizarsin?
English: By blocking the breakdown of cGMP, Vizarsin restores erectile function.
Maltese: L-EPAR sħiħ ta' Vizarsin jinstab fis-sit elettroniku tal-Aġenzija:
English: Sexual stimulation is still needed to produce an erection.
Maltese: Biex Vizarsin ikun effikaċi, jenħtieġ ikun hemm stimulazzjoni sesswali.
English: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem Belgium
Maltese: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem
English: The active substance is sirolimus.
Maltese: Is-sustanza attiva hi sirolimus.
English: Clostridium difficile colitis;
Maltese: Clostridium difficile;
English: Sucrose and lactose
Maltese: Sucrose u lactose
English: Date of latest renewal: 13 March 2011
Maltese: Data tal-aħħar tiġdid: 13 ta' Marzu 2011
English: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG United Kingdom
Maltese: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG Ir-Renju Unit
English: St. John's Wort (Hypericum perforatum).
Maltese: John's Wort (Hypericum perforatum).
English: Do not take Rapamune:
Maltese: Tiħux Rapamune:
English: Sirolimus is extensively metabolised by O-demethylation and/or hydroxylation.
Maltese: Sirolimus huwa metabolizzat estensivament b'O-demethylation u/jew hydroxylation.
English: 60 mL oral solution.
Maltese: 60 mL soluzzjoni orali.
English: Side effect frequencies
Maltese: Frekwenzi tal-effetti sekondarji
English: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co. Kildare Ireland
Maltese: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co.
English: Rash; Acne
Maltese: Raxx; Akne
English: Rapamune contains ethanol (alcohol)
Maltese: Rapamune fih ethanol (alkoħol)
English: There is a general tendency for fluid to collect in various tissues.
Maltese: Hemm tendenza ġenerali li l-fluwidu jakkumula f'diversi tessuti.
English: Oedema peripheral;
Maltese: Edema periferali;
English: Rapamune oral solution contains up to 3.17 vol % ethanol (alcohol).
Maltese: Rapamune soluzzjoni orali fih sa 3.17 vol% ta' ethanol (alkoħol).
English: Infectious diarrhoea with Clostridium difficile
Maltese: Dijarea infettiva bi Clostridium difficile
English: Also contains: lactose monohydrate, sucrose.
Maltese: Fih ukoll: lactose monohydrate, sucrose.
English: Yellow iron oxide (E172)
Maltese: Iron oxide kannella (E172)
English: No clinically significant pharmacokinetic interaction was observed between Rapamune oral solution and 0.3 mg norgestrel/0.03 mg ethinyl estradiol.
Maltese: Ma kienet osservata l-ebda interazzjoni farmakokinetika klinikament sinifikanti bejn soluzzjoni orali ta' Rapamune u 0.3 mg norgestrel/0.03 mg ethinyl estradiol.
English: Oral tablet
Maltese: Pillola Orali
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari:jista' jaffettwa sa persuna 1 minn kull 1,000
English: The mean Cmax was decreased by 35%, and mean tmax increased by 82%.
Maltese: Cmax medja tnaqqset b'35% u tmax medja żdied b'82%.
English: Lymphangioleiomyomatosis (LAM)
Maltese: Limfanġjolejomijomatożi (LAM)
English: Pancytopaenia; Thrombotic thrombocytopaenic purpura
Maltese: Panċitopenija; Purpura tromboċitopenika trombotika
English: Rapamune contains up to 3.17 vol % ethanol (alcohol).
Maltese: Rapamune fih sa 3.17 % vol ta' ethanol (alkoħol).
English: Herpes simplex infection;
Maltese: Infezzjoni b'herpes simplex;
English: CARTONS - PACK SIZES 30 AND 100 TABLETS
Maltese: KARTUN - PAKKETTI Ta' 30 U 100 PILLOLA
English: Coated tablet (tablet).
Maltese: Pillola miksija (pillola).
English: HMG-CoA reductase inhibitors
Maltese: Inibituri ta' HMG-CoA reductase
English: (Cyprus Branch) T : +357 22 817690
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch) T : +357 22 817690
English: Uncommon (≥1/1,000 to
Maltese: Mhux komuni (≥1/1000 sa
English: Alveolar proteinosi s
Maltese: Proteinosi alveolari
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8, 5.1 u 5.2, imma l-ebda rakkomandazzjoni dwar ilpożoloġija ma tista' tingħata.
English: The safety and efficacy of Rapamune for treatment of S-LAM were assessed in a randomised, double-blind, multicentre, controlled trial.
Maltese: Is-sigurtà u l-effikaċja ta' Rapamune għall-kura ta' S-LAM ġew ivvalutati fi prova randomizzata, double-blind, multiċentrika, ikkontrollata.
English: *Note: p-values not controlled for multiple testing.
Maltese: *Nota: valuri-p mhux ikkontrollati għall-ittestjar multiplu.
English: The 0.5 mg and 2 mg tablets also contain yellow iron oxide (E172) and brown iron oxide (E172).
Maltese: Il-pilloli ta' 0.5 mg u 2 mg fihom ukoll iron oxide isfar (E172) u iron oxide kannella (E172).
English: any other immunosuppressant medicines.
Maltese: Immunosoppressanti, immunosoppressanti selettivi.
English: Pulmonary embolism;
Maltese: Emboliżmu pulmonari;
English: 30 dosing syringes 1 syringe adapter 1 carrying case
Maltese: 30 siringa tad-dożaġġ 1 adapter tas-siringi 1 kaxxa li ġġorrha miegħek
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17
Maltese: Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: Tablet core: lactose monohydrate, macrogol, magnesium stearate, talc Tablet coating: macrogol, glycerol monooleate, pharmaceutical glaze, calcium sulfate, microcrystalline cellulose, sucrose, titanium dioxide, poloxamer 188, -tocopherol, povidone, carnauba wax, Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone).
Maltese: Il-kisja tal-pillola: macrogol, glyceryl monooleate, pharmaceutical glaze, anhydrous calcium sulfate, microcrystalline cellulose, sucrose, titanium dioxide, poloxamer 188, -tocopherol, povidone, carnauba wax, Linka tal-istampar (Shellac, Iron Oxide Aħmar, Propylene Glycol [E1520], Soluzzjoni ta' Ammonja
English: Epstein-Barr virus infection
Maltese: Infezzjoni bil-virus Epstein-Barr
English: Polysorbate 80 (E433) and phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids, and ascorbyl palmitate).
Maltese: Polysorbate 80 (E433) u phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-u diglycerides, ethanol, soya fatty acids, u ascorbyl palmitate).
English: Experimental evidence suggests that sirolimus binds to the specific cytosolic protein FKPB-12, and that the FKPB 12-sirolimus complex inhibits the activation of the mammalian Target Of Rapamycin (mTOR), a critical kinase for cell cycle progression.
Maltese: Evidenza mill-esperimenti turi li sirolimus jintrabat ma' proteina ċitosolika speċifika FKPB-12, u li l-kumpless FKPB 12-sirolimus jinibixxi l-attivazzjoni tal-mammalian Target Of Rapamycin (mTOR), kinase kritiku għal progressjoni taċ-ċiklu ċellulari.
English: Careful attention should be made to clinical signs/symptoms, tissue biopsies, and laboratory parameters.
Maltese: Għandha tingħata attenzjoni bir-reqqa lil sinjali/sintomi kliniċi, bijopsiji ta' tessuti u parametri tal-laboratorju.
English: Rapamune 1 mg/mL oral solution sirolimus
Maltese: Rapamune 1 mg/mL soluzzjoni orali sirolimus
English: Rapamune contains lactose and sucrose
Maltese: Rapamune fih lactose u sucrose
English: Phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids and ascorbyl palmitate).
Maltese: Phosal 50 PG (phosphatidyl choline, propylene glycol [E1520], mono-u diglycerides, ethanol, soya fatty acids, u ascorbyl palmitate).
English: Rapamune 2 mg coated tablets EU/1/01/171/009-010
Maltese: Rapamune 2 mg pilloli miksija EU/1/01/171/009-010
English: At steady-state, 8 children aged 6-11 years received mean  SD doses of 1.75  0.71 mg/day (0.064  0.018 mg/kg, 1.65  0.43 mg/m2) while 14 adolescents aged 12-18 years received mean  SD doses of 2.79  1.25 mg/day (0.053  0.0150 mg/kg, 1.86  0.61 mg/m2).
Maltese: Fl-istat fiss, 8 itfal ta' bejn letajiet ta' 6-11-il sena rċivew dożi medji  SD ta' 1.75  0.71 mg/kuljum (0.064  0.018 mg/kg, 1.65  0.43 mg/m2) filwaqt li 14-il adolexxent ta' bejn l-etajiet ta' 12-18-il sena rċivew dożi medji  SD ta' 2.79  1.25 mg/kuljum (0.053  0.0150 mg/kg, 1.86  0.61 mg/m2).
English: Sirolimus administered concomitantly (5 mg), and at 2 hours (5 mg) and 4 hours (10 mg) after CsA (300 mg), resulted in increased sirolimus AUC by approximately 183%, 141% and 80%, respectively.
Maltese: Sirolimus mogħti fl-istess ħin (5 mg), u wara sagħtejn (5 mg) u 4 sigħat (10 mg) wara CsA (300 mg), irriżulta f'żieda fl-AUC ta' sirolimus ta' madwar 183%, 141% u 80%, rispettivament.