FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall success rate (defined as excellent or good) for treatment of bleeds was 95% with 98% of the bleeds treated with one or two injections.
Maltese: Ir-rata globali ta' suċċess (definita bħala eċċellenti jew tajba) għall-kura tal-fsada kienet ta' 95% b'98% tal-episodji ta' fsada kkurati b'injezzjoni waħda jew b'żewġ injezzjonijiet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU
Maltese: U KWANTITATTIVA Refixia 500
English: All patients assessed in the steady state pharmacokinetic session had factor IX activity levels above 0.24 IU/ml at 168 hours post dosing with a weekly dose of 40 IU/kg.
Maltese: Il-pazjenti kollha evalwati fis-sessjoni farmakokinetika fl-istat fiss kellhom livelli ta' attività ta' fattur IX li kienu aktar minn 0.24
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Maltese: Reazzjonijiet allerġiċi huma possibbli b'din il-mediċina.
English: Skin and subcutaneous tissue disorders
Maltese: Lasta tal-planġer
English: Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Maltese: Minħabba r-riskju ta' reazzjonijiet allerġiċi b'fattur IX, il-kura inizjali tiegħek b'Refixia għandha tingħata fi klinika medika jew fil-preżenza ta' professjonisti tal-kura tas-saħħa fejn tkun tista' tiġi pprovduta kura medika xierqa għal reazzjonijiet allerġiċi jekk ikun meħtieġ.
English: Factor IX is a single chain glycoprotein.
Maltese: • jekk inti allerġiku għall-proteini tal-ħamster.
English: Refixia is administered by intravenous bolus injection over several minutes after reconstitution of the powder for injection with the histidine solvent.
Maltese: Refixia jingħata permezz ta' injezzjoni f'daqqa ġol-vini fuq diversi minuti wara r-rikostituzzjoni tattrab għall-injezzjoni bis-solvent histidine.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Maltese: Jekk id-doża tiegħek teħtieġ aktar minn kunjett wieħed, irrepeti l-passi A sa J b'kunjetti, adapters tal kunjett u siringi mimlijin għal-lest addizzjonali, sakemm ikollok id-doża meħtieġa.
English: Volume of distribution (Vss) (ml/kg) Factor IX activity 168 h post dosing (IU/ml)
Maltese: (IU*sigħat/ml) Tneħħija (CL) (ml/siegħa/kg)
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10);
Maltese: Il-frekwenzi ġew stmati skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa
English: Use of a reference laboratory is recommended when a chromogenic assay or a qualified one-stage clotting assay is not available locally.
Maltese: L-użu ta' laboratorju ta' referenza hu rakkomandat meta assaġġ kromoġeniku jew assaġġ ta' tagħqid tad-demm fi stadju wieħed ikkwalifikat ma jkunux disponibbli lokalment.
English: Refixia is used to treat and prevent bleeding in patients 12 years and above with haemophilia B (inborn factor IX deficiency).
Maltese: Refixia jintuża biex jikkura u jipprevjeni l-ħruġ ta' demm f'pazjenti minn 12-il sena 'l fuq b'emofilja B (defiċjenza tal-fattur IX mit-twelid).
English: Powder
Maltese: Kartuna
English: Allergic type hypersensitivity reactions are possible with Refixia.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip allerġiku huma possibbli b'Refixia.
English: • 1 pre-filled syringe with solvent
Maltese: • siringa waħda mimlija għal-lest bis-solvent
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni nonacog beta pegol
English: Degree of haemorrhage
Maltese: Reġistrazzjoni tal-użu
English: Dosing recommendations
Maltese: Refixia 2000
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (≤ 30°C) or 24 hours in a refrigerator (2°C - 8°C), unless reconstitution has taken place under controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, il-ħinijiet u l-kondizzjonijiet tal-ħażna qabel u waqt l-użu huma r-responsabbiltà ta' min ikun qed jużah u s-soltu ma jkunx irrakkomandat li jkunu aktar minn 4 sigħat meta jinħażen f'temperatura tal-kamra (≤30°C) jew 24 siegħa fil-friġġ (2°C - 8°C), ħlief jekk ir-rikostituzzjoni tkun saret f'kundizzjonijiet asettiċi kkontrollati u vvalidati.
English: Refixia 500 IU powder and solvent for solution for injection Refixia 1000 IU powder and solvent for solution for injection Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol
Maltese: Jekk tuża Refixia aktar milli suppost Jekk tuża Refixia aktar milli suppost, ikkuntattja lit-tabib tiegħek.
English: Unopened
Maltese: INDIVIDWALI
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol
Maltese: IU trab għal soluzzjoni għall-injezzjoni nonacog beta pegol
English: Injecting Refixia via needleless connectors for intravenous (IV) catheters
Maltese: Kif jidher Refixia u l-kontenuti tal-pakkett
English: Leave the plunger rod untouched in the carton.
Maltese: Ħalli l-lasta tal-planġer bla ma tmissha fil-kartuna.
English: There were no apparent differences in the pharmacokinetic profiles between normal weight and overweight patients.
Maltese: Ma kien hemm l-ebda differenzi apparenti fil-profili farmakokinetiċi bejn pazjenti li kellhom piż normali u dawk b'piż żejjed.
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Maltese: Meta tinjetta s-soluzzjoni permezz ta' apparat li jagħti aċċess għall-vina ċentrali (CVAD) bħal kateter ġo vina ċentrali jew apparat taħt il-ġilda:
English: Three trials of which one trial was a dedicated surgery trial included in total 15 major and 26 minor surgery procedures (patients aged 13 to 56 years).
Maltese: Tliet provi, li minnhom prova waħda kienet prova kirurġika ddedikata, kienu jinkludu total ta' 15-il proċedura kirurġika maġġuri u 26 proċedura kirurġika minuri (pazjenti li kellhom minn 13 sa
English: Intraarticular use Applicator (PU)
Maltese: Użu għal ġol-ġogi Applikatur (PU)
English: 1 to 10 sterile tubes with 1 prefilled syringe each +1 indwelling cannula or 1 filter stem per prefilled syringe
Maltese: Tubu sterili 1 sa 10 tubi sterili b'mhux aktar minn żewġ applikaturi kull wieħed + siringa 1 għal kull applikatur
English: Intraarticular use Pre-filled syringe (PP)
Maltese: Siringa mimlija minn qabel (PP)
English: MA (EU) Number Invented name
Maltese: Numru MA (UE) Isem ivvintat Qawwa
English: 1 to10 sterile tubes with up to 2 applicators each + 1 syringe per applicator
Maltese: Tubu sterili 1 sa 10 tubi sterili b
English: Applicant/marketing authorisation holder
Maltese: Marketing authorisation holder Name
English: 88326 Aulendorf GERMANY
Maltese: 88326 Aulendorf
English: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN
Maltese: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPANJA
English: Rua Agualva dos Açores n.º 16 2735-557 Agualva-Cacém, PORTUGAL
Maltese: Rua Agualva dos Açores n.º 16 2735-557 Agualva-Cacém, IL-PORTUGAL
English: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE
Maltese: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANZA
English: D-85716 Unterschleißheim GERMANY
Maltese: D-85716 Unterschleißheim IL-ĠERMANJA
English: United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM
Maltese: Ir-Renju Unit Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ IR-RENJU UNIT
English: 192 07 Sollentuna SWEDEN
Maltese: 192 07 Sollentuna L-ISVEZJA
English: Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIA
Maltese: Intervet GmbH Siemensstraße 107 AT-1210
English: Intervet Nederland B.V. p.o. box 50
Maltese: Il-Pajjiżi l-Baxxi Intervet Nederland B.V. p.o. box 50
English: 3 CVMP note for guidance for the determination of withdrawal periods in milk (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf
Maltese: 3 Nota għall-gwida tas-CVMP għall-istabbiliment tal-perjodi ta' tiżmim fil-ħalib (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf
English: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf below the MRL values in kidney and liver.
Maltese: VICH GL48: Studji għall-evalwazzjoni tal-metaboliżmu u l-kinetika tar-residwi ta' mediċini veterinarji f'annimali li jipproduċu l-ikel: studji dwar it-tneħħija ta' residwi markaturi biex jiġu stabbiliti perjodi ta' tiżmim għall-prodotti (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 Nota għall-gwida tas-CVMP: approċċ lejn l-armonizzazzjoni tal-perjodi ta' tiżmim (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf u l-fwied.
English: 5830 AB Boxmeer THE NETHERLANDS
Maltese: 5830 AB Boxmeer
English: United Kingdom Eurovet Animal Health B.V. Handelsweg 25
Maltese: Eurovet Animal Health B.V. Handelsweg 25
English: Intervet Deutschland GmbH Feldstr.
Maltese: Il-Ġermanja Intervet Deutschland GmbH Feldstr. 1a
English: 4941 VX Raamsdonksveer THE NETHERLANDS
Maltese: 4941 VX Raamsdonksveer IR-RENJU UNIT
English: Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS
Maltese: Wim de Körverstraat 35 5831, AN Boxmeer IL-PAJJIŻI
English: Albrecht GmbH Hauptstr.
Maltese: Il-Ġermanja Albrecht GmbH Hauptstr. 6-8
English: According to the current product information for Dexadreson, treatment may be repeated after 24-48 hours.
Maltese: Skont l-informazzjoni attwali dwar il-prodott għal Dexadreson, ilkura tista' tiġi ripetuta wara 24-48 siegħa.
English: Conclusions on the benefit-risk balance
Maltese: 3. Valutazzjoni Benefiċċji/Riskji
English: Milk: 72 hours
Maltese: 72 siegħa
English: All studies were conducted at a single dose of 0.06 mg/kg body weight.
Maltese: L-istudji kollha saru b'doża unika ta' 0.06 mg/kg tal-piż tal-ġisem.
English: Therefore, on 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for Dexadreson 2 mg/ml and associated names, and generic products thereof.
Maltese: Għalhekk, fit-22 ta' Awwissu 2012, il-Ġermanja ppreżentat notifika ta' riferiment lill-Aġenzija skont lArtikolu 35 tad-Direttiva 2001/82/KE għal Dexadreson 2 mg/ml u ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu.
English: Due to shortcomings in the design of the study, a maximum safety span of 30% was considered necessary, leading to a withdrawal period of 8 days for the single dose treatment at 0.06 mg dexamethasone per kg body weight.
Maltese: Minħabba nuqqasijiet fid-disinn tal-istudju, kienet meqjusa neċessarja firxa massima ta' sigurtà ta' 30%, li twassal għal perjodu ta' tiżmim ta' 8 ijiem għall-kura bid-doża unika ta' 0.06 mg ta' dexamethasone għall kull kg tal-piż tal-ġisem.
English: The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products are solutions for injection which contain 2 mg dexamethasone per ml.
Maltese: Il-prodotti mediċinali veterinarji Dexadreson 2 mg/ml u l-ismijiet assoċjati u l-prodotti ġeneriċi tiegħu huma soluzzjonijiet għall-injezzjoni li fihom 2 mg ta' dexamethasone f'kull ml.
English: Czech republic Intervet International B.V. Wim de Körverstraat 35
Maltese: Wim de Körverstraat 35
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, anti-allergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Maltese: Dexamethasone huwa glukokortikojd sintetiku li jaħdem fit-tul li jintuża bħala sustanza antiinfjammatorja, kontra l-allerġiji u glukoneoġenetika li tingħata lill-annimali agrikoli u domestiċi.
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjodu ta' tiżmim
English: Belgium Dopharma Research B.V. Zalmweg 24
Maltese: Id-Danimarka Dopharma Research B.V. Zalmweg 24
English: Therefore a 20% safety span was applied to the observed period of 60 hours, resulting in a withdrawal period of 72 hours, i.e. 3 days, in milk from cows treated at a single dose of 0.06 mg dexamethasone per kg body weight.
Maltese: Għalhekk ġiet applikata firxa ta' sigurtà ta' 20% għall-perjodu osservat ta' 60 siegħa, li wasslet għal perjodu ta' tiżmim ta' 72 siegħa, jiġifieri 3 ijiem, fil-ħalib minn baqar li ngħataw doża unika ta' 0.06 mg ta' dexamethasone għal kull kg tal-piż tal-ġisem.
English: Overall summary of the scientific evaluation of Dexadreson 2 mg/ml and associated names, and generic products thereof (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Dexadreson 2 mg/ml u ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu (ara Anness I)
English: • In the absence of residue depletion or pharmacokinetic data following a repeat treatment in cattle and horses for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that the advice on repeat dose treatment after 24-48 hours in cattle and horses should be removed from the product information;
Maltese: • Fin-nuqqas ta' dejta dwar it-tneħħija tar-residwi jew dejta farmakokinetika wara kura ripetuta filbaqar u ż-żwiemel għal Dexadreson 2 mg/ml u ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu, isCVMP ħass li l-parir dwar kura b'doża ripetuta wara 24-48 siegħa fil-baqar u ż-żwiemel għandu jitneħħa mill-informazzjoni dwar il-prodott;
English: • the CVMP considered that the overall benefit-risk balance is positive for Dexadreson 2 mg/ml and associated names, and generic products thereof subject to amendments in the product information; the CVMP has recommended variations of the marketing authorisations for Dexadreson 2 mg/ml and associated names, and generic products thereof (see annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in annex III.
Maltese: is-CVMP irrakkomanda varjazzjonijiet fl-awtorizzazzjonijiet għat-tqegħid fis-suq għal Dexadreson 2 mg/ml u ismijiet assoċjati, u l-prodotti ġeneriċi tiegħu (ara anness I) sabiex jiġu emendati s-sommarji tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljetti ta' tagħrif f'konformità mattibdil rakkomandat fl-informazzjoni dwar il-prodott kif stabbilit fl-anness III.
English: In the absence of residue depletion data at the maximum intended dose and further to the concerns expressed above, the marketing authorisation holders agreed to remove the advice on repeat dose treatment after 24-48 hours in cattle from the product information.
Maltese: Fin-nuqqas ta' dejta dwar ittneħħija tar-residwi fid-doża massima maħsuba u wara t-tħassib espress hawn fuq, id-detenturi talawtorizzazzjoni għat-tqegħid fis-suq qablu li jneħħu l-parir dwar kura b'doża ripetuta wara 24-48 siegħa fil-baqar mill-informazzjoni dwar il-prodott.
English: Delete, where applicable, “in cases of shock in horses”.
Maltese: Ħassar, fejn applikabbli, "f'każijiet ta' xokk fiż-żwiemel".
English: Therefore, none of the studies was conducted at the maximum intended dose as requested in VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)1 and safe withdrawal periods in cattle tissues and milk can only be set for single treatment.
Maltese: Għalhekk, l-ebda wieħed mill-istudji ma kien sar bid-doża massima maħsuba kif mitlub fil-VICH GL48: Studji li jevalwaw il-metaboliżmu u l-kinetika tar-residwi ta' mediċini veterinarji f'annimali li jipproduċu l-ikel: studji dwar it-tneħħija ta' residwi markaturi biex jiġu stabbiliti perjodi ta' tiżmim għall-prodotti (EMA/CVMP/VICH/463199/2009)1 u l-perjodi siguri ta' tiżmim fit-tessuti u l-ħalib tal-baqar jistgħu jiġi stabbiliti biss għal kura unika.
English: Residue depletion data was made available and supported a cattle meat and offal withdrawal period of 8 days and a cattle milk withdrawal period of 72 hours, as well as a horse meat and offal withdrawal period of 8 days following a single injection at the recommended dose of 0.06 mg dexamethasone per kg body weight.
Maltese: Saret disponibbli dejta dwar it-tneħħija tar-residwi li appoġġjat perjodu ta' tiżmim ta' 8 ijiem għallaħam u l-ġewwieni tal-baqar u perjodu ta' tiżmim ta' 72 siegħa għall-ħalib tal-baqar, kif ukoll perjodu ta' tiżmim ta' 8 ijiem għal-laħam u l-ġewwieni taż-żwiemel wara injezzjoni unika bid-doża rakkomandata ta' 0.06 mg ta' dexamethasone għal kull kg tal-piż tal-ġisem.
English: Dexamethasone 2 mg/ml
Maltese: Dexadreson injekció A.U.V. Dexamethasone 2 mg/ml
English: Belgium Eurovet Animal Health B.V. Handelsweg 25
Maltese: Is-Slovakkja Eurovet Animal Health B.V.
English: The same withdrawal period for edible tissues may be applied for cattle and horses for the same dosing regimen, resulting in a withdrawal period for horse meat and offal of 8 days for the single dose treatment of 0.06 mg dexamethasone per kg body weight.
Maltese: Listess perjodu ta' tiżmim għat-tessut li jittiekel jista' jiġi applikat għall-baqar u ż-żwiemel għall-istess skeda ta' dożaġġ, li jirriżulta f'perjodu ta' tiżmim għal-laħam u l-ġewwieni taż-żwiemel ta' 8 ijiem għallkura b'doża unika ta' 0.06 mg ta' dexamethasone għal kull kg tal-piż tal-ġisem.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, saħħa tal-prodotti mediċinali veterinarji, speċi ta' annimal, detenturi talawtorizzazzjoni għal-tqegħid fis-suq fl-iStati Membri
English: As there were no residue depletion data with the recommended repeat dose treatment in cattle and horses, the CVMP concluded that the advice on repeat dose treatment in cattle and horses should be removed from the product information.
Maltese: Ħassar, fejn applikabbli, referenzi kollha għal trattament ripetut fil-baqar u żwiemel u trattament f'każijiet ta' xokk fiż-żwiemel.
English: The other study was considered valid, however, the data set obtained from it did not allow the use of the statistical approach for the determination of withdrawal periods in accordance with the CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)2 as statistical criteria for the linear regression analysis were not fulfilled.
Maltese: Listudju l-ieħor kien meqjus validu, madankollu, is-sett ta' dejta li nkiseb minnu ma ppermettiex l-użu tal-approċċ statistiku biex jiġu stabbiliti l-perjodi ta' tiżmim skont in-nota għall-gwida tas-CVMP: approċċ lejn l-armonizzazzjoni tal-perjodi ta' tiżmim (EMEA/CVMP/036/95)2 peress li l-kriterji statistiċi għall-analiżi ta' rigressjoni lineari ma kinux issodisfati.
English: Polyethylene glycol Lecithin (soy)
Maltese: Polyethylene glycol Lecithin (sojja)
English: INFORMATION IN BRAILLE dificlir
Maltese: INFORMAZZJONI BIL-BRAILLE dificlir
English: DIFICLIR is available in:
Maltese: DIFICLIR hu disponibbli fi:
English: Antimicrobial spectrum
Maltese: Spettru antimikrobijali
English: Date of latest renewal: 22 August 2016
Maltese: Data tal-aħħar tiġdid: 22 ta` Awissu 2016
English: Microcrystalline cellulose Pregelatinised starch (maize) Hydroxypropyl cellulose Butylated hydroxytoluene Sodium starch glycolate Magnesium stearate
Maltese: Microcrystalline cellulose Pregelatinised starch (maize) Microcrystalline cellulose Butylated hydroxytoluene Sodium starch glycolate Magnesium stearate
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003 100 x 1 film-coated tablet EU/1/11/733/004 20 x 1 film-coated tablet 13.
Maltese: EU/1/11/733/003 100 x 1 pillola miksija b'rita EU/1/11/733/004 20 x 1 pillola miksija b'rita
English: MedDRA system organ class
Maltese: Klassi talorgani tassistemaMedD RA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003-004
Maltese: EU/1/11/733/003-004
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, antibiotics, ATC code: A07AA12
Maltese: Mediċini kontra d-dijarea, sustanzi intestinali antiinfjammatorji/antiinfettivi, antibijotiċi,Kodiċi ATC:A07AA12 Mekkaniżmu ta' azzjoni
English: This difference is not considered clinically relevant.
Maltese: Din id-differenza mhijiex meqjusa klinikament rilevanti.
English: Table 1: Summary of adverse reactions by MedDRA system organ class
Maltese: Tabella 1: Sommarju tar-reazzjonijiet avversi skont il-klassi tal-organi tas-sistema
English: Adults and elderly (≥65 years of age)
Maltese: Adulti u anzjani (≥ 65 sena)
English: Astellas Pharma Tlf: +47 6676 4600
Maltese: Tlf: +47 6676 4600
English: Hepatobiliary disorders alanine aminotransferase increased
Maltese: Disturbi filfwied u filmarrara żieda f'alanine aminotransferase
English: − rash, itching (pruritus)
Maltese: − raxx, ħakk (prurite)
English: − The other ingredients are: Tablet core: microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate and magnesium stearate Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol and lecithin (soy)
Maltese: Qalba tal-pillola:microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate u magnesium stearate Kisja:polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol u lecithin (sojja)
English: In the two clinical trials of patients with CDI, 47.9% (479/999) of patients (per protocol population) were ≥65 years of age and 27.5% (275/999) of patients were treated with concomitant antibiotics during the study period.
Maltese: Fiż-żewġ provi kliniċi ta' pazjenti b'CDI, 47.9% (479/999) ta' pazjenti (skont il-protokoll talpopolazzjoni) li kellhom ≥ 65 sena, u 27.5% (275/999) tal-pazjenti, ġew ikkurati b'antibijotiċi fl-istess ħin matul il-perjodu tal-istudju.
English: België/Belgique/Belgien Astellas Pharma B.V.
Maltese: België/Belgique/Belgien Astellas Pharma B.V. Branch Tél/Tel:
English: Fidaxomicin does not induce or inhibit CYP450 enzymes in vitro.
Maltese: Fidaxomicin ma jinduċix jew jinibixxi enzimi CYP450 in vitro.
English: − ketoconazole (a medicine used to treat fungal infections)
Maltese: - ketoconazole (mediċina li tintuża għall-kura ta' infezzjonijiet fungali)
English: Fidaxomicin is a locally acting drug.
Maltese: Fidaxomicin huwa mediċina li taġixxi lokalment.
English: Fidaxomicin has an MIC90 of 0.25 mg/L versus C. difficile, and its main metabolite, OP-1118, has an MIC90 of 8 mg/L.
Maltese: Fidaxomicin għandu MIC90 ta' 0.25 mg/l versus C. difficile, u l-metabolit ewlieni tiegħu, OP-1118, għandu MIC90 ta' 8 mg/L.
English: Fidaxomicin is a narrow spectrum antimicrobial drug with bactericidal activity against C. difficile.
Maltese: Fidaxomicin huwa mediċina bi spettru antimikrobijali dejjaq, b'attività batteriċidjali kontra C. difficile.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hi definita kif ġej: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000);