FrancophonIA/ELRC3.0 huggingface dataset:
English: London, 29 May 2007 Doc.Ref.
Maltese: Londra 29 ta' Mejju 2007 Dok.Ref.
English: EMEA/144030/2007
Maltese: EMEA/CHMP/274899/2007
English: The Marketing Authorisation Holder provided supplementary information on 21 September 2006 and 12 January 2007.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda tagħrif supplimentari fil-21 ta' Settembru 2006 u fit-12 ta' Jannar 2007.
English: Xefo and associated names, 4mg and 8mg film-coated tablets, 8mg rapid film coated tablet, and 8mg powder and solvent for solution for injection, is a non-steroidal anti-inflammatory drug (NSAID), used for short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.
Maltese: Xefo u ismijiet assoċjati, pilloli miksijin b'rita ta' 4mg u 8 mg, pillola rapida miksija b'rita ta' 8mg, u trab u solvent għal soluzzjoni għal injezzjoni ta' 8mg, huwa mediċina mhux sterojde kontra l-infjammazzjoni (NSAID), użata għal serħan mill-uġigħ ħafif għal moderat akut għal perjodu ta' żmien qasir, serħan sintomatiku mill-uġigħ u infjammazzjoni fl-oseoartrite u serħan sintomatiku ta' uġigħ u ta' linfjammazzjoni fl-artrite rewmatojde.
English: BACKGROUND INFORMATION
Maltese: TAGĦRIF TA' SFOND
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Xefo and associated names International Non-Proprietary Name (INN): lornoxicam
Maltese: KUMITAT GĦAL PRODOTTI MEDIĊINALI GĦAL UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA ARTIKLU 30 TA' REFERENZA GĦAL Xefo u ismijiet assoċjati Isem Mhux Patentat tal-Prodott (INN): lornoxicam
English: On 16 May 2006 Nycomed Denmark Aps presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Package Leaflets and Labelling of the medicinal product Xefo and associated names.
Maltese: Fis-16 ta' Mejju 2006 Nycomed Danmark Aps ippreżentat referenza lill-EMEA taħt l-Artikolu 30 tadDirettiva 2001/83/KE, sabiex tarmonizza s-Sommarji tal-Karatteristiċi tal-Prodott (SPC), Fuljetti ta' Tagħrif u t-Tikketti tal-prodott mediċinali Xefo u ismijiet assoċjati awtorizzati fuq livell nazzjonali.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics of Xefo and associated names approved across EU Member States, with respect to the short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.
Maltese: Il-bażi għal referenza kienet li kien hemm diverġenzi fis-Sommarji tal-Karatteristċi tal-Prodott ta' Xefo u ismijiet assoċjati approvati fost l-Istati Membri ta' l-UE, fir-rigward tas-serħan għal qasir żmien minn uġigħ ħafif għal moderat akut, serħan sintomatiku mill-uġigħ u infjammazzjoni fl-oseoartrite u serħan sintomatiku mill-uġigħ u infjammazzjoni fl-artrite rewmatojde.
English: The CHMP gave a positive opinion on 22 February 2007 recommending the harmonisation of the SPC, labelling and package leaflet for Xefo and associated names.
Maltese: Is-CHMP ta opinjoni pożittiva fit-22 ta' Frar 2007 fejn irrikmanda l-armonizzazzjoni tal-SPC, tikketta u fuljett ta' tagħrif għal Xefo u ismijiet assoċjati.
English: During its February 2007 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
Maltese: Waqt il-laqgħa tiegħu ta' Frar 2007, is-CHMP, fid-dawl tat-tagħrif totali sottomess u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien ta' l-opinjoni li l-proposta għal armonizzazzjoni ta' l-SPC, Tikketta u Fuljett ta' Tagħrif kienet aċċettabbli u li dawn għandhom jiġu emendati.
English: After 48 weeks, 89% of the patients taking Atripla (181 out of 203) and 88% of those remaining on previous treatment (85 out of 97) had viral loads below 200 copies/ml.
Maltese: Wara 48 ġimgħa, 89 % tal-pazjenti li ħadu Atripla (181 minn 203) u 88 % ta' dawk li baqgħu fuq il-kura preċedenti (85 minn 97) kellhom tagħbijiet virali anqas minn 200 kopja/ml.
English: The three active substances in Atripla are: efavirenz (600 mg), emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Maltese: It-tliet sustanzi attivi f'Atripla huma: efavirenz (600 mg), emtriċitabina (200 mg) u tenofovir disoprossil (245 mg).
English: Other information about Atripla
Maltese: Informazzjoni oħra dwar Atripla
English: Further information on Atripla can be found on the Agency's website ema.europa.eu/en/medicines/human/EPAR/Atripla.
Maltese: Aktar informazzjoni dwar Atripla tista' tinstab fuq is-sit web tal-Aġenzija ema.europa.eu/medicines/human/EPAR/Atripla
English: Atripla is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Atripla huwa mediċina antivirali li tintuża biex tikkura adulti infettati bil-virus-1 tal-immunodefiċjenza umana (HIV-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: • voriconazole (used to treat fungal infections).
Maltese: • vorikonażol (użata biex tikkura infezzjonijiet fungali).
English: • St John's wort (a herbal preparation used to treat depression);
Maltese: • Fexfiex tar-raba' (St John's wort) (preparazzjoni erbali użata għall-kura tad-depressjoni);
English: In the European Union (EU), efavirenz has been approved since 1999, emtricitabine has been approved since 2003, and tenofovir disoproxil has been approved since 2002.
Maltese: Fl-Unjoni Ewropea (UE), efavirenz ilha approvata sa mill-1999, emtriċitabina ilha approvata sa mill2003, u tenofovir disoprossil ilha approvata sa mill-2002
English: What are the risks associated with Atripla?
Maltese: X'inhuma r-riskji assoċjati ma' Atripla?
English: Atripla contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: Atripla fih tliet sustanzi attivi: l-efavirenz, li hija inibitur mhux nukleosidiku tat-transkriptażi inversa (NNRTI, non-nucleoside reverse transcriptase inhibitor); l-emtriċitabina, li hija inibitur nukleosidiku tattranskriptażi inversa; u t-tenofovir disoprossil, li hija “prodroga” tat-tenofovir, jiġifieri li tinbidel fissustanza attiva tenofovir fil-ġisem.
English: Atripla received a marketing authorisation valid throughout the EU on 13 December 2007.
Maltese: Atripla rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-13 ta' Diċembru 2007.
English: The most common side effects with Atripla (which may affect more than 1 patient in 10) are dizziness, headache, diarrhoea, nausea (feeling sick), vomiting, rash, asthenia (weakness), hypophosphataemia (low blood levels of phosphates) and elevated levels of creatine kinase (an enzyme found in muscles).
Maltese: L-effetti sekondarji l-aktar komuni b'Atripla (li jistgħu jaffettwaw aktar minn pazjent wieħed minn kull 10) huma sturdament, uġigħ ta' ras, dijarrea, nawżja (tħossok ma tiflaħx), remettar, raxx, astenja (dgħjufija), ipofosfatimija (livelli baxxi ta' fosfati fid-demm) u livelli għoljin ta' kinażi tal-kreatina (enżima li normalment tinsab fil-muskoli).
English: How is Atripla used?
Maltese: Kif jaħdem Atripla?
English: The main study of Atripla included 300 patients whose HIV infection was already being successfully treated with various combinations of antiviral medicines.
Maltese: L-istudju prinċipali ta' Atripla inkluda 300 pazjent li l-infezzjoni tagħhom tal-HIV kienet diġà qed tiġi kkurata b'suċċess b'diversi kombinazzjonijiet ta' mediċini antivirali.
English: The main measure of effectiveness was the proportion of patients whose viral loads were below 200 copies/ml after 48 weeks.
Maltese: Ilkejl ewlieni tal-effikaċja kien il-proporzjon ta' pazjenti b'tagħbijiet virali anqas minn 200 kopja/ml wara 48 ġimgħa.
English: The company that markets Atripla will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as Atripla.
Maltese: Il-kumpanija li tqiegħed lil Atripla fis-suq se tiżgura li t-tobba kollha li mistennija jippreskrivu lmediċina jiġu pprovduti b'pakkett edukattiv li jinkludi informazzjoni dwar iż-żieda fir-riskju ta' mard filkliewi b'mediċini li fihom it-tenofovir disoprossil bħal Atripla.
English: All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and make more viruses.
Maltese: It-tliet sustanzi attivi kollha jimblokkaw l-attività tat-traskriptażi inversa, enzima prodotta mill-HIV li tippermetti lil virus li jinfetta ċ-ċelloli u jagħmel aktar viruses.
English: As for all medicines, data on the use of Atripla are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Atripla hija ssorveljata kontinwament.
English: For the full list of side effects reported with Atripla, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Atripla, ara l-fuljett ta' tagħrif.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Maltese: Kemm inibituri nukleosidiċi kif ukoll nukleotidiċi tat-transkriptażi inversa huma magħrufa b'mod komuni bħala NRTIs.
English: It is recommended that Atripla is taken on an empty stomach, preferably at bedtime.
Maltese: Huwa rakkomandat li Atripla jittieħed fuq stonku vojt, preferibbilment qabel il-ħin tal-irqad.
English: • medicines that cause QT prolongation;
Maltese: • mediċini li jikkawżaw it-titwil tal-QT;
English: Atripla (efavirenz / emtricitabine / tenofovir disoproxil)
Maltese: Għaliex Atripla ġie awtorizzat fl-UE?
English: It must also not be used in patients who have had arrhythmia (abnormal heartbeat) and patients with abnormal levels of electrolytes in the blood (for example, potassium or magnesium).
Maltese: Lanqas ma għandu jintuża f'pazjenti li kellhom arritmija (taħbit tal-qalb anormali) u f'pazjenti b'livelli anormali ta' elettroliti fid-demm (pereżempju, potassju jew manjeżju).
English: See the package leaflet for further details and for the full list of restrictions.
Maltese: Picture string contains unmatched quotes..
English: Side effects reported with Atripla are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Atripla huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: • certain medicines whose breakdown is blocked or accelerated by Atripla;
Maltese: • ċertu mediċini li d-dekompożizzjoni tagħhom tkun imwaqqfa jew aċċelerata minn Atripla;
English: The Agency decided that Atripla's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Maltese: L-Aġenzija ddeċidiet li l-benefiċċji ta' Atripla huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: 13 December 2019 EMA/189409/2019
Maltese: 13 ta' Diċembru 2019 EMA/189409/2019
English: More information on Trisenox can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/trisenox
Maltese: ema.europa.eu/en/medicines/human/EPAR/trisenox
English: Trisenox has been authorised in the European Union since November 2016.
Maltese: Trisenox ilu awtorizzat fl-Unjoni Ewropea minn Novembru 2016.
English: Total content
Maltese: Kontenut totali
English: Vial of 6 ml
Maltese: Kunjett ta' 6 ml
English: Both should be diluted with 100-250 ml of either glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection
Maltese: It-tnejn għandhom jiġu dilwiti b'100-250 ml ta' jew glucose 50 mg/ml (5%) soluzzjoni għall-injezzjoni jew sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni
English: Ampoule of 10 ml
Maltese: Ampolla ta' 10 ml
English: Dilution
Maltese: Dilwizzjoni
English: Trisenox is a medicine used to treat adults with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic translocation (when there is a swap of genes between two chromosomes).
Maltese: Trisenox hija mediċina li tintuża biex tikkura adulti b'lewkimja promjeloċitika akuta (APL), forma rari ta' lewkimja (kanċer taċ-ċelloli bojod tad-demm) ikkawżata minn trażlokazzjoni ġenetika (meta jkun hemm tpartit tal-ġeni bejn żewġ kromożomi).
English: Strength
Maltese: Preżentazzjoni
English: • A new presentation of Trisenox (vial containing 2 mg/ml arsenic trioxide) will be introduced to replace the existing presentation (ampoule containing 1 mg/ml arsenic trioxide).
Maltese: • Ser tiġi introdotta preżentazzjoni ġdida ta' Trisenox (kunjett li fih 2 mg/ml triossidu tal-arseniku) biex tissostitwixxi l-preżentazzjoni eżistenti (ampolla li fiha 1 mg/ml triossidu tal-arseniku).
English: Front of the carton
Maltese: Preżentazzjoni attwali
English: In addition, the new vial contains a total volume of 6 ml (and a total content of 12 mg arsenic trioxide) whereas the existing ampoule contains 10 ml (and a total content of 10 mg).
Maltese: Barra minn hekk, il-kunjett il-ġdid fih volum totali ta' 6 ml (u kontenut totali ta' 12 mg triossidu tal-arseniku) filwaqt li l-ampolla eżistenti fiha 10 ml (u kontenut totali ta' 10 mg).
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and contains the active ingredient arsenic trioxide.
Maltese: Dan jiġi f'konċentrat li jsir f'soluzzjoni għall-infużjoni (dripp) ġo vina, u fih l-ingredjent attiv triossidu tal-arseniku.
English: The European Medicines Agency (EMA) has recommended the approval of a new presentation of the injectable cancer medicine Trisenox (arsenic trioxide) that contains 2 mg/ml of the active substance in each vial.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat l-approvazzjoni ta' preżentazzjoni ġdida talmediċina tal-kanċer li tista' tiġi injettata Trisenox (triossidu tal-arseniku) li fiha 2 mg/ml tas-sustanza attiva f'kull kunjett.
English: In addition, the new presentation contains a total volume of 6 ml (and a total content of 12 mg) whereas the existing presentation contains 10 ml (and a total content of 10 mg).
Maltese: Barra minn hekk, il-preżentazzjoni l-ġdida fiha volum totali ta' 6 ml (u kontenut totali ta' 12 mg) filwaqt li l-preżentazzjoni eżistenti fiha 10 ml (u kontenut totali ta' 10 mg).
English: EMA issues alert on the risk of dosing errors with the cancer medicine Trisenox
Maltese: L-EMA toħroġ twissija dwar ir-riskju ta' żbalji fid-dożaġġ bil-mediċina tal-kanċer Trisenox
English: A letter with this information will be sent to healthcare professionals.
Maltese: Ser tintbagħat ittra b'din l-informazzjoni lill-professjonisti tal-kura tas-saħħa.
English: The new presentation will replace the existing one, which contains 1 mg/ml in each ampoule.
Maltese: Il-preżentazzjoni l-ġdida ser tissostitwixxi dik eżistenti, li fiha 1 mg/ml f'kull ampolla.
English: Whereas underdosing may result in an inadequate effect overdose can result in serious and potentially fatal complications such as bleeding, severe infections and cardiac arrest.
Maltese: Filwaqt li dożaġġ baxx jista' jirriżulta f'effett inadegwat, doża eċċessiva tista' tirriżulta f'kumplikazzjonijiet serji u potenzjalment fatali bħal fsada, infezzjonijiet severi u attakk talqalb.
English: • Both formulations will coexist until stocks of the one containing 1 mg/ml have all been used.
Maltese: • Iż-żewġ formulazzjonijiet ser jeżistu flimkien sakemm il-ħażniet ta' dik li fiha 1 mg/ml jkunu ntużaw kollha.
English: 3 capsules a
Maltese: 3 kapsuli a
English: 117 Allée des Parcs 69800 Saint-Priest France
Maltese: 117 Allée des Parcs 69 800 Saint Priest Franza
English: Bilirubin - Indirect
Maltese: Bilirubin - Indiretta
English: HCV-RNA negative
Maltese: HCV-RNA negattiv
English: PVC/Aclar
Maltese: PVC/Aclar - Aluminju
English: - Pregnancy (see sections 4.4, 4.6 and 5.3).
Maltese: - Tqala (ara sezzjonijiet 4.4, 4.6 u 5.3).
English: Genotype 2/3/4 (n = 26)
Maltese: Ġenotip 2/3/4 (n = 26)
English: Naïve patients
Maltese: Pazjenti naive
English: Psychiatric and Central Nervous System (CNS):
Maltese: Sistema Psikjatrika u Sistema Nervuża Ċentrali (CNS):
English: Propylene glycol Ammonia solution, concentrated Yellow iron oxide (E172) Indigotine (E132) Titanium dioxide (E171)
Maltese: Propylene glycol Ammonia solution, konċentrata Yellow iron oxide (E172) Indigotine (E132) Titanium dioxide (E171)
English: Titanium dioxide (E171) Capsule imprint:
Maltese: Titanium dioxide (E171) L-istampar tal-kapsula:
English: Table 15
Maltese: Tabella 15.
English: *AUC12 (ng.hr/ml) for ribavirin; AUC0-24 (IU.hr/ml) for interferon alfa-2b
Maltese: *AUC12 (ng.hr/ml) għal ribavirin; AUC0-24 (IU.hr/ml) għal interferon alfa-2b
English: By Week 12*** (n= 915)
Maltese: Ma' Ġimgħa 12*** (n=915)
English: Gwent, NP22 3AA United Kingom
Maltese: Gwent, NP22 3AA Ir-Renju Unit
English: GSP Proizvodi d.o.o Tel: +386 1 236 31 85
Maltese: GSP Proizvodi d.o.o Tél: +386 1 236 31 85
English: Ribavirin Dose (mg/kg)
Maltese: Doża ta' ribavirin (mg/kg)
English: Adult: ≥ 12g/dL (females); ≥ 13g/dL (males) Children and adolescents: ≥ 11g/dL (females); ≥ 12g/dL (males)
Maltese: Adulti:  12 g/dL (nisa);  13 g/dL (irġiel) Tfal u adolexxenti:  11 g/dL (bniet);  12 g/dL (subien)
English: EU/1/10/634/001 EU/1/10/634/002 EU/1/10/634/003 EU/1/10/634/004 EU/1/10/634/005 EU/1/10/634/006 EU/1/10/634/007 EU/1/10/634/008 EU/1/10/634/009 EU/1/10/634/010 EU/1/10/634/011
Maltese: EU/1/10/634/007 EU/1/10/634/008 EU/1/10/634/009 EU/1/10/634/010
English: Ribavirin in combination with Direct Antiviral Agent (DAA):
Maltese: Ribavirin flimkien ma' Aġent Antivirali Diretti (DAA):
English: P 1.5/R P 0.5/R
Maltese: P 1.5/R
English: Elderly (≥ 65 years of age)
Maltese: Anzjani (età ta' ≥ 65 sena)
English: Tabulated list of adverse reactions in paediatric population
Maltese: Lista tabulata ta' reazzjonijiet avversi fil-popolazzjoni pedjatrika
English: The capsule shell imprint contains shellac, propylene glycol, strong ammonia solution, colouring agents (E172, E132, E171).
Maltese: L-istampar fuq il-qoxra tal-kapsula fih shellac, propylene glycol, strong ammonia solution, colouring agents (E172, E132, E171).
English: Male: impotence, prostatitis, erectile dysfunction.
Maltese: Raġel: impotenza, prostatite, funzjoni ħażina ta' l-erezzjoni.
English: Pack sizes of 84, 112, 140 and 168 capsules.
Maltese: Daqsijiet tal-pakkett ta' 84, 112, 140 u 168 kapsula.
English: Tabulated list of adverse reactions for adults
Maltese: Lista tabulata ta' reazzjonijiet avversi għall-adulti
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Maltese: Ribavirin 15 mg/kg/jum maqsuma f'2 dożi (n = 17)
English: Table 14
Maltese: Tabella 14.
English: Sustained virologic response
Maltese: Rispons Viroloġiku Sostnut
English: 2 capsules in the morning and 2 capsules in the evening See adult dose
Maltese: 2 kapsuli filgħodu u 2 kapsuli filgħaxija Ara d-doża ta' l-adulti
English: Nucleoside analogues
Maltese: Analogi tan-Nuklejosajd
English: Ribavirin has two pathways of metabolism: 1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite.
Maltese: Ribavirin għandu żewġ passaġġi ta' metaboliżmu: 1) passaġġ riversibbli tal-fosforilazzjoni; 2) degradazzjoni li tinvolvi t-tneħħija ta' ribose (deribosylation) u amide hydrolysis li tipproduċi metabolu triazole carboxyacid.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
Maltese: Kienu reklutati totall ta' 118 pazjent: 57 raġel, 80 % Kawkażi, u 78 % ġenotip 1, 64 %  12-il sena.
English: 56x1 hard capsules 84x1 hard capsules 112x1 hard capsules 140x1 hard capsules 168x1 hard capsules56 hard capsules 84 hard capsules
Maltese: 56x1 kapsuli ibsin 84x1 kapsuli ibsin 112x1 kapsuli ibsin 140x1 kapsuli ibsin 168x1 kapsuli ibsin 56 kapsuli ibsin 84 kapsula iebsa 112-il kapsula iebsa 140 kapsula iebsa 168 kapsula iebsa
English: Ribavirin (Ribavirin Mylan) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Maltese: Ribavirin (Ribavirin Mylan) huwa analogu sintetiku tan-nuklejosajd li wera attività in vitro kontra xi vajrusis ta' l-RNA u d-DNA.
English: p Value a
Maltese: valur a
English: Ribavirin was active in the Balb/3T3 in vitro Transformation Assay.
Maltese: Ribavirin kien attiv fit-Test tat-Trasformazzjoni tal-Balb/3T3 in vitro.
English: For patients receiving a 800 mg (< 65 kg)-1,000 mg (65-80 kg)-1,200 mg (81-105 kg) or 1,400 mg
Maltese: Għal pazjenti li jingħataw doża ta' 800 mg (< 65 kg)-1,000 mg (65-80 kg)-1,200 mg (81-105 kg) jew 1,400 mg (> 105 kg), l-1
English: Genotype 1/4 59.7 (129/216)
Maltese: Ġenotip 1, 4 17 % (21/125)
English: Excipient with known effect: each hard capsule contains 15 mg of lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf: kull kapsula iebsa fiha 15 mg ta' lactose monohydrate.
English: Ribavirin does not inhibit cytochrome P450 enzymes.
Maltese: Ribavirin ma timpedixxix l-enżimi tas-cytochrome P450.
English: There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Maltese: Hemm diversi reazzjonijiet avversi serji assoċjati mat-terapija kombinata ta' ribavirin u (peg)interferon alfa.
English: Capsule contents:
Maltese: Qoxra tal-kapsula:
English: peginterferon alfa-2b (100 or cµg/week)
Maltese: d peginterferon alfa-2b (100 or cµg/ġimgħa
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin, 6% discontinued therapy due to adverse reactions.
Maltese: Fi provi kliniċi b'118 tfal u adolexxenti ta' 3 sa 16-il sena kkurati b'terapija kombinata b'interferon alfa-2b u ribavirin, 6 % waqfu t-terapija minħabba reazzjonijiet avversi.
English: Arthralgia, myalgia, musculoskeletal pain
Maltese: Artralġja, mijalġja, uġigħ muskolu-skeletrali
English: Cardboard box containing 56x1, 84x1, 112x1, 140x1, 168x1 hard capsules in PVC/Aclar - Aluminium foil perforated unit dose blisters
Maltese: Kaxxa tal-kartun li fiha 56x1, 84x1, 112x1, 140x1, 168x1 kapsuli ibsin f'PVC/Aclar - Folji perforati tad-doża tal-unità magħmula minn fojl tal-aluminju Jista jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għal skop kummerċjali.
English: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Maltese: Sindrome ta' Vogt-Koyanagi-Harada, lupus erythematosus sistemiku, vaskulite, reazzjonijiet ta' sensittività eċċessiva inkluża urtikarja, anġjo-edema, bronkokostrizzjoni, anafilassi
English: The Ribavirin Mylan hard capsule is available in different pack sizes:
Maltese: Il-kapsula iebsa Ribavirin Mylan hi disponibbli f'daqsijiet ta' pakketti differenti:
English: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%.
Maltese: Il-biodisponibbiltà ta' ribavirin 600 mg kienet imnaqqsa meta ngħata flimkien ma' antaċidi li kien fihom magnesium aluminium u simethicone; l-AUCtf tnaqqas b'14 %.
English: Date of first authorisation: 10 June 2010 Date of latest renewal: 11 February 2015
Maltese: Data tal-aħħar tiġdid: 11 ta' Frar 2015