FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with emtricitabine/tenofovir disproxil in the paediatric population with HIV-1 infection.
Maltese: Hemm inċertezzi marbuta mal-effetti fit-tul fuq il-kliewi u l-għadam ta' tenofovir disoproxil matul ittrattament tal-infezzjoni bl-HIV-1 fil-popolazzjoni pedjatrika.
English: If serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving Emtricitabine/Tenofovir disoproxil Krka d.d., renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-fosfat fis-serum jiġi kkonfermat li hu < 3.0 mg/dL (0.96 mmol/L) fi kwalunkwe pazjent pedjatriku li jkun qed jirċievi Emtricitabine/Tenofovir disoproxil Krka d.d., il-funzjoni renali għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, b'kejl li jinkludi l-glukożju fid-demm, potassju fid-demm u konċentrazzjonijiet tal-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Interaction with didanosine: Co-administration of tenofovir disoproxil and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti ta' tenofovir disoproxil flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of Emtricitabine/Tenofovir disoproxil Krka d.d..
Maltese: Preparazzjonijiet separati ta' emtricitabine u tenofovir disoproxil huma disponibbli għat-trattament talinfezzjoni tal-HIV-1 jekk ikun meħtieġ li titwaqqaf jew tiġi modifikata d-doża ta' wieħed millkomponenti ta' Emtricitabine/Tenofovir disoproxil Krka d.d..
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartuni ta' barra li fihom flixkun 2 ta' 30 pillola miksija b'rita u 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: As Emtricitabine/Tenofovir disoproxil Krka d.d.
Maltese: X'fih Emtricitabine/Tenofovir disoproxil Krka d.d.
English: The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir.
Maltese: Il-mutazzjoni K65R tista' ukolltintgħażel minn abacavir jew didanosine u tikkawża tnaqqis fis-sensittività għal dawn il-mediċini flimkien ma' lamivudine, emtricitabine u tenofovir.
English: Adefovir dipivoxil and Emtricitabine/Tenofovir disoproxil Krka d.d.
Maltese: Kif taħżen Emtricitabine/Tenofovir disoproxil Krka d.d.
English: should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues, such as lamivudine (see section 4.4).
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. m'għandhux jingħata fl-istess ħin ma' prodotti mediċinali oħrajn li fihom emtricitabine, tenofovir disoproxil, tenofovir alafenamide jew analogi ta' cytidine oħra, bħal lamivudine (ara sezzjoni 4.4).
English: (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Maltese: Tiħux Emtricitabine/Tenofovir disoproxil Krka d.d. jekk diġà qed tieħu mediċini oħra li fihom il-komponenti ta' Emtricitabine/Tenofovir disoproxil Krka d.d. (emtricitabine u tenofovir disoproxil) jew kwalunkwe mediċina antivirali oħra li fihom tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/mL, and change from baseline in CD4 cell count.
Maltese: L-analiżi ta' leffikaċja sekondarja fuq perjodu ta' 144 ġimgħa kienet tinkludi l-proporzjon ta' pazjenti b'konċentrazzjonijiet tal-RNA tal-HIV-1 ta' < 400 jew < 50 kopja/mL, u l-bidla mil-linja bażi fl-għadd taċ-ċelluli tas-CD4.
English: Pack sizes: 28 and 84 film-coated tablets.
Maltese: OPA/Alu/PE+DES/ - Folji tal-aluminju Daqs tal-pakkett: 28 u 84 pillola miksija b'rita.
English: Blisters OPA/Alu/PE+DES/ - Aluminium blisters.
Maltese: Effetti fuq il-kliewi u l-għadam fl-adulti
English: If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Krka d.d., whether or not you also have HIV.
Maltese: Jekk għandek HBV, hemm riskju serju ta' problemi tal-fwied meta tieqaf tieħu Emtricitabine/Tenofovir disoproxil Krka d.d., kemm jekk għandek l-HIV jew le.
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.
Maltese: Din ir-reazzjoni avversa kienet identifikata minn sorveljanza ta' wara t-tqegħid fis-suq iżda mhux osservata fi studji kliniċi kkontrollati randomised fuq pazjenti adulti jew fi studji kliniċi fuq persuni pedjatriċi bl-HIV għal emtricitabine jew fi studji kliniċi kkontrollati randomised jew il-programm ta' aċċess imkabbar ta' tenofovir disoproxil għal tenofovir disoproxil.
English: No dose adjustment of norgestimate/ethinyl oestradiol is required.
Maltese: L-ebda aġġustament fid-doża ta' norgestimate/ethinyl oestradiol
English: Increased plasma concentrations of tenofovir resulting from co administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir u lopinavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: contains lactose", "Emtricitabine/Tenofovir disoproxil Krka d.d.
Maltese: Mediċini oħra u Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Maltese: - Jekk twaqqaf il-pilloli jista' jnaqqas l-effettività tat-terapija kontra l-HIV rakkomandata mit tabib tiegħek.
English: is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see section 4.2, 4.4 and 5.1).
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. huwa indikat ukoll għat-trattament ta' adolexxenti infettati b'HIV-1, b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' sustanzi ppreferuti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Very common side effects (may affect more than 1 in 10 people) diarrhoea, being sick (vomiting), feeling sick (nausea) dizziness, headache rash feeling weak
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni) - dijarea, tibda tirremetti (rimettar), tħossok imdardar (nawseja) - sturdament, uġigħ ta' ras - raxx - tħossok dgħajjef
English: should be initiated by a physician experienced in the management of HIV infection.
Maltese: - Kwalunkwe sinjali ta' infjammazzjoni jew infezzjoni.
English: Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Maltese: Ilfunzjoni renali għandha tkun immonitorjata mill-qrib (ara sezzjoni 4.4).
English: Studies with emtricitabine
Maltese: Studji b'emtricitabine
English: Scientific conclusions
Maltese: Konklużjonijiet Xjentifiċi
English: On 8 September 2014, Aastrom Biosciences notified the European Medicines Agency of the withdrawal by the Danish authorities of the manufacturing licence for the manufacturing site for the active substance, finished product and batch release of MACI (matrix-applied characterised autologous cultured chondrocytes): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK - 2770 Kastrup, Denmark.
Maltese: Fit-8 ta' Settembru 2014, Aastrom Biosciences innotifikat lill-Aġenzija Ewropea għall-Mediċini bl-irtirar mill-awtoritajiet Daniżi tal-liċenza ta' manifattura għas-sit tal-manifattura tas-sustanza attiva, ilprodott lest u l-ħruġ tal-lott ta' MACI (kondroċiti kkulturati awtologi kkaratterizzati applikati f'matriċi): Genzyme Biosurgery ApS, Oliefabriksvej 45, DK - 2770
English: Grounds for the suspension of the marketing authorisation
Maltese: Raġunijiet għas-sospensjoni tal-awtorizzazzjoni għat-tqegħid
English: The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Maltese: Is-CHMP ikkunsidra li din l-informazzjoni ma għandhiex impatt fuq il-profil tas-sigurtà u l-effikaċja ta' MACI iżda li fin-nuqqas ta' sit tal-manifattura awtorizzat, ir-rekwiżiti stabbiliti fl-Artikolu 41 tadDirettiva 2001/83/KE ma għadhomx jiġu ssodisfati iktar.
English: For the suspension to be lifted, the MAH shall register a manufacturing site for the active substance, finished product and batch release (see Annex II).
Maltese: Biex titneħħa s-sospensjoni, il-MAH għandu jirreġistra sit tal-manifattura għas-sustanza attiva, ilprodott lest u l-ħruġ tal-lott (ara l-Anness
English: In view of the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 10 September 2014, requesting the Agency to give its opinion on whether the marketing authorisation for MACI should be suspended or revoked in accordance with Article 118 of
Maltese: Fid-dawl ta' dan, il-Kummissjoni Ewropea bdiet proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 fl-10 ta' Settembru 2014, fejn talbet lill-Aġenzija sabiex tagħti l-opinjoni tagħha dwar jekk lawtorizzazzjoni għat-tqegħid fis-suq għal MACI għandhiex tiġi sospiża jew revokata skont l-Artikolu
English: • The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
Maltese: • Il-Kumitat ikkonkluda li fid-dawl ta' nuqqas ta' sit awtorizzat tal-manifattura għas-sustanza attiva, il-prodott lest u l-ħruġ tal-lott, ir-rekwiżiti stabbiliti fl-Artikolu 41 tad-Direttiva 2001/83/KE ma
English: • The Committee considered the notification under Article 20 of Regulation (EC) No 726/2004 for
Maltese: • Il-Kumitat ikkunsidra n-notifika skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal MACI u l-abbozz tal-opinjoni tas-CHMP ippreparata mill-CAT (Kumitat għat-Terapiji Avvanzati)
English: ATC vet code: QI07AB01.
Maltese: QI07AB01.
English: Vaccination against distemper, adeno, parvo and parainfluenza virus (DHPPi):
Maltese: Tilqim kontra distemper, adeno, parvo u parainfluenza virus (DHPPi):
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injections
Maltese: Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Ilma għall-injezzjonijiet
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/171/001
Maltese: FIS-SUQ EU/2/14/171/001
English: VIAL (1 ML SUSPENSION)
Maltese: VJALA (SOSPENSJONI 1 ML) ISEM
English: Pharmacotherapeutic group: Immunologicals for canidae, inactivated bacterial vaccines.
Maltese: Immunoloġiċi għal canidae, vaċċini batteriċi inattivati.
English: Suspension:
Maltese: Tul tal-immunità:
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Maltese: It-tilqima hija intenzjonata għall-immuniżazzjoni attiva fi ġriewi f'saħħithom u klieb kontra mard ikkawżat mill-Leptospira interrogens serogrupp Australis serovar Bratislava, Leptospira interrogens serogrupp Canicola serovar Canicola, Leptospira kirschneri serogrupp Grippotyphosa serovar
English: Plastic box containing 50 vials (1 ml).
Maltese: Kaxxa tal-plastik b'50 vjala (1 ml).
English: Plastic box containing 25 vials (1 ml).
Maltese: Kaxxa tal-plastik b'25 vjala (1 ml).
English: Primary vaccination scheme: Two doses of Versican Plus L4 3-4 weeks apart from 6 weeks of age.
Maltese: Żewġ dożi ta' Versican Plus L4 3 - 4 ġimgħat minn xulxin minn età ta' 6 ġimgħat.
English: Type I glass vial containing 1 ml closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Vjala tal-ħġieġ Type I li fiha 1 ml magħluqa b'tapp tal-chlorobutyl rubber u kappa tal-aluminju.
English: Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus L4.
Maltese: Tal-anqas sena wara l- kors ta' tilqim primarju għall-komponenti kollha ta' Versican Plus L4.
English: If protection against DHPPi or Pi is required, dogs can be vaccinated with two doses of Versican Plus DHPPi or Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi or Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Maltese: Jekk hemm bżonn ta' protezzjoni kontra DHPPi jew Pi, il-klieb jistgħu jitlaqqmu b'żewġ dożi ta' Versican Plus DHPPi jew Versican Plus Pi imħalta ma' Versican Plus L4 3-4 ġimgħat minn xulxin minn età ta' 6 ġimgħat.
English: Appearance: whitish liquid with fine sediment.
Maltese: Dehra: likwidu bajdani b'sediment fin.
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Sospensjoni:
English: Dogs
Maltese: KAXXA
English: Incompatibilities:
Maltese: Inkompatibilita jiet:
English: PACKAGE LEAFLET: Versican Plus L4 suspension for injection for dogs
Maltese: Versican Plus L4 sospensjoni għall-injezzjoni għall-klieb
English: ADVICE ON CORRECT ADMINISTRATION Shake well and administer immediately the entire contents (1 ml) of the product.
Maltese: Ħallat sew u immedjatament amministra l-kontenut kollu (1 ml) tal-prodott.
English: Onset of immunity: 4 weeks after the completion of primary course.
Maltese: Bidu tal-immunità: 4 ġimgħat wara li jintemm il-kors primarju.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 for dogs
Maltese: Doża wahda ta' Versican Plus L4 għandha tingħata kull sena.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products except those mentioned in section 4.8.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra ħlief dawk imsemmija f'sezzjoni 4.8.
English: Suspension (inactivated):
Maltese: Sos pe nsjoni (inattivat):
English: 10 DATE OF REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: 10 July 2015
Maltese: 10 ta' Lulju 2015
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm hemm nuqqas ta' evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawżibbli u hemm evidenza li ntużaw b'dan il-mod b'sigurtà għal tal-inqas 30 sena (inkluż tal-inqas 15-il sena fl-UE).
English: Further information on the risks associated with mouse-ear hawkweed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini bil-ħaxixa bl-għeruq tal-Heraċju, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab 'Id-dokumenti kollha' fis-sit web tal-Aġenzija:
English: Mouse-ear hawkweed is the common name for the above-ground parts (which may include flowers) and parts of the root of the plant Hieracium pilosella L. The plant is cultivated or gathered to obtain the plant parts for medicinal use.
Maltese: Il-ħaxixa bl-għeruq tal-Heraċju huwa l-isem komuni għall-partijiet ta' fuq l-art (li jistgħu jinkludu lfjuri) u partijiet mill-għeruq tal-pjanta Hieracium pilosella L.
English: Moreover, the intended use does not require medical supervision.
Maltese: Barra minn hekk, l-użu intiż ma jeħtieġx superviżjoni medika.
English: Further information on the HMPC assessment of mouse-ear hawkweed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini bil-ħaxixa bl-għeruq tal-Heraċju, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit web talAġenzija:
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-ħaxixa bl-għeruq tal-Heraċju.
English: The HMPC noted the lack of clinical studies with mouse-ear hawkweed, but took into account the well documented use of this herbal medicine for the above uses.
Maltese: Fiż-żmien tal-valutazzjoni tal-HMPC, ebda effetti sekondarji ma kienu ġew rapportati b'dawn il-mediċini.
English: Mouse-ear hawkweed medicines are generally well tolerated.
Maltese: Il-mediċini bil-ħaxixa bl-għeruq tal-Heraċju normalment huma ttollerati sew.
English: Other information about mouse-ear hawkweed medicines
Maltese: Aktar informazzjoni dwar il-mediċini bil-ħaxixa bl-għeruq tal-Heraċju
English: The HMPC concluded that, on the basis of its long-standing use, mouse-ear hawkweed can be used as a mild diuretic (a medicine to increase production of urine) for the relief of minor problems of the urinary tract (the structures that carry urine).
Maltese: L-HMPC ikkonkluda li, abbażi tal-użu għal żmien twil tagħha, il-ħaxixa bl-għeruq tal-Heraċju tista' tintuża bħala dijuretiku ħafif (mediċina li żżid il-produzzjoni tal-awrina) għas-serħan minn problemi żgħar tal-apparat urinarju (l-istrutturi li jwasslu l-awrina).
English: Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth.
Maltese: Mediċini erbali li fihom il-ħaxixa bl-għeruq tal-Heraċju normalment huma disponibbli bħala tè biex jinxtorob jew forom solidi biex jittieħdu mill-ħalq.
English: What are the risks associated with mouse-ear hawkweed medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini bil-ħaxixa bl-għeruq tal-Heraċju?
English: Mouse-ear hawkweed should only be used in adults.
Maltese: Il-ħaxixa bl-għeruq tal-Heraċju għandha tintuża biss fl-adulti.
English: Further information on Posaconazole Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
Maltese: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
English: • fusariosis (fungal infection caused by Fusarium),
Maltese: • fusarjożi (infezzjoni fungali kkawżata mill-Fusarium),
English: • invasive aspergillosis (fungal infection caused by Aspergillus),
Maltese: • asperġillożi invażiva (infezzjoni fungali kkawżata minn Aspergillus),
English: Posaconazole Accord (posaconazole) EMA/320670/2019
Maltese: EMA/320670/2019
English: Posaconazole Accord is available as gastro-resistant tablets (100 mg).
Maltese: Posaconazole Accord jiġi bħala pillola li ma tinħallx fl-istonku (100 mg).
English: Posaconazole Accord is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Maltese: Posaconazole Accord huwa mediċina antifungali li tintuża biex tikkura adulti li jbatu mill-mard fungali li ġej, meta kuri b'mediċini antifungali oħrajn (amphotericin B, itraconazole jew fluconazole) ma jkunux jistgħu jiġu ttollerati jew ikunu fallew:
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Maltese: • kromoblastomijako\i u majċetoma (infezzjonijiet fungali fit-tul tal-ġilda jew it-tessut eżatt taħt il ġilda, normalment ikkawżati minn spori fungali li jinfettaw ġrieħi kkawżati minn skaldi jew xfar),
English: Posaconazole Accord contains the active substance posaconazole and is a ‘generic medicine'.
Maltese: Posaconazole Accord fih is-sustanza attiva posakonażol u huwa "mediċina ġenerika".
English: Other information about Posaconazole Accord
Maltese: Aktar informazzjoni dwar Posaconazole Accord
English: The active substance in Posaconazole Accord, posaconazole, is an antifungal medicine that belongs to the triazole group.
Maltese: Is-sustanza attiva f'Posaconazole Accord, il-posakonażol, hija mediċina antifungali li tappartjeni lillgrupp tat-trijażol.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Maltese: Din taħdem billi tipprevjeni l-formazzjoni tal-ergosterol, li huwa parti importanti millħitan taċ-ċelloli fungali.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole Accord.
Maltese: Studji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat diġà twettqu bil-mediċina ta' referenza, Noxafil, u m'għandhomx għalfejn jiġu ripetuti għal Posaconazole Accord.
English: The recommended dose is 300 mg twice a day on the first day followed by 300 mg once a day thereafter; the duration of treatment depends on the severity of the disease and the patient's response.
Maltese: Id-doża rakkomandata hija ta' 300 mg darbtejn kuljum fl-ewwel jum segwita minn 300 mg darba kuljum wara dan; it-tul ta' żmien tal-kura jiddependi fuq il-gravità tal-marda u r-rispons tal-pazjent.
English: Posaconazole Accord is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Maltese: Posaconazole Accord jintuża wkoll biex jipprevjeni infezzjonijiet fungali invażivi f'pazjenti li s-sistema immunitarja tagħhom hija mdgħajfa minħabba kuri li qed jirċievu għal kanċers tal-mudullun jew taddemm jew mediċini użati fi trapjant ta' ċelloli staminali ematopojetiċi (proċedura fejn il-mudullun talpazjent jinbidel b'ċelloli staminali minn donatur biex jifforma mudullun ġdid).