FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml of vaccine (homogeneous milky white suspension) contains: Active substance: .Inactivated Bluetongue Virus Serotype 1 ............................................................... ≥ 1.9 log10 pixels * (*) Antigen content (VP2 protein) by immuno-assay Adjuvants: .Al3+ (as hydroxide) .................................................................................................................. 2.7 mg .Saponin .................................................................................................................................. 30 HU** (**)Haemolytic units
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Maltese: F'din il-kategorija ta' annimali il-vaċċin għandu jintuża biss skont kif il-veterinarju responsabbli iqis il-benefiċċju / riskju tal-prodott u/jew skond il-kompetenti awtoritajiet nazzjonali fuq il-politika kurrenti dwar il-tilqim kontra l-virus tal-Bluetongue (BTV).
English: IMMUNOLOGICAL PROPERTIES
Maltese: Unità emolitiċi
English: Store and transport refrigerated (2 °C-8 °C) Do not freeze
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C-8 °C) Tagħmlux fil-friża
English: PHARMACEUTICAL FORM Homogeneous milky white suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni omoġena bajda qisa ħalib għal injezzjoni.
English: In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm2).
Maltese: 24 cm fin-nagħaġ) li ssir residual wara 35 ġurnata (≤ 1 cm
English: Manufacturer responsible for batch release: MERIAL
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ: MERIAL
English: Shelf life after first opening the immediate packaging: immediately Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP:
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' din it-tilqima meta tintuża flimkien ma' kwalunkwe prodott mediċinali veterinarju ieħor.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma ebda prodott mediċinali veterinarju ieħor.
English: Any person intending to manufacture, import, possess, sell, supply and/or use BTVPUR AlSap 1 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timmanifattura, timporta, tippossedi, tbigħ, tipprovdi u/jew tuża BTVPUR AlSap 1 għandha l-ewwel tikkonsulta mal-Awtorità Kompetenti tal-Istat Membru dwar il-programmi ta' tilqim kurrenti.
English: Polypropylene bottle of 50 or 100 ml with butyl elastomere closure Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Maltese: Flixkun tal-polypropylene ta' 50 jew 100 ml b'tapp tal-butyl elastomere Kaxxa ta' flixkun ta' 100 doża (1 x 100 ml) Kaxxa ta' 10 fliexken ta' 100 doża (10 x 100 ml) Kaxxa ta' flixkun ta' 50 doża (1 x 50 ml) Kaxxa ta' 10 fliexken ta' 50 doża (10 x 50 ml)
English: EXPIRY DATE EXP {month/year} Once broached, use immediately
Maltese: PROJBIZZJONI TA' BEJGĦ, PROVISTA, U/JEW UŻU
English: EMA/315814/2014 EMEA/V/C/003753
Maltese: EMEA/V/C/003753
English: Terbinafine, florfenicol and betamethasone
Maltese: Terbinafine / florfenicol / betamethasone acetate
English: Florfenicol is an antibiotic which works by blocking protein formation in bacterial cells.
Maltese: Florfenicol huwa antibijotiku li jaħdem billi jwaqqaf il-formazzjoni tal-proteini fiċ-ċelloli batterjali.
English: Osurnia is a veterinary medicine that contains three active substances: terbinafine, florfenicol and betamethasone acetate.
Maltese: Osurnia hija mediċina veterinarja li għandha tliet sustanzi attivi: terbinafine, florfenicol u betamethasone acetate.
English: Two of the active substances in Osurnia terbinafine and florfenicol, act against possible causes of infection.
Maltese: Tnejn mis-sustanzi attivi f'Osurnia li huma terbinafine u florfenicol, jaħdmu kontra kawżi possibbli ta' infezzjoni.
English: What is the risk associated with Osurnia?
Maltese: X'riskji huma assoċjati ma' Osurnia?
English: Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Maltese: Terbinafine joqtol il-fungi billi jwaqqaf il-formazzjoni tal-ergosterol, parti importanti mill
English: Why has Osurnia been approved?
Maltese: Għaliex ġie approvat Osurnia?
English: The Japanese study involved 71 dogs; 49 dogs were treated with Osurnia and 22 dogs with another ear medicine containing clotrimazole (for fungal infections), gentamicin (an antibiotic) and betamethasone valerate (corticosteroid).
Maltese: L-istudju Ġappuniż involva 71 kelb u kelba; 49 kelb u kelba ġew trattati b'Osurnia u 22 b'mediċina oħra tal-widnejn li fiha clotrimazole (għallinfezzjonijiet fungali), gentamicin (antibijotiku) u betamethasone valerate (kortikosterojde).
English: Osurnia is used to treat short lived or recurrent ear infections (otitis externa) due to Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast).
Maltese: Osurnia jintuża biex jittratta infezzjonijiet tal-widnejn fuq perjodu ta' żmien qasir jew dawk rikorrenti (otitis externa) ikkawżati minn Staphylococcus pseudintermedius (batterju) u Malassezia pachydermatitis (tip ta' ħmira).
English: The US study involved 284 dogs, 190 of which were treated with Osurnia, while 90 dogs received placebo gel (dummy treatment).
Maltese: L-istudju fl-Istati Uniti involva 284 kelb u kelba, li minnhom 190 ġew trattati b'Osurnia, filwaqt li 90 kelb u kelba rċevew plaċebo (trattament finta).
English: In the EU study Osurnia was as effective as the comparator medicine with both treatments resulting in 63% reduction in severity of otitis externa.
Maltese: Fl-istudju tal-UE, Osurnia kien effettiv daqs il-mediċina li tqabbel magħha, fejn iż-żewġ trattamenti rriżultaw fi tnaqqis ta' 63% fis-severità tal-otitis esterna.
English: The first was an EU study involving 286 dogs in which 148 dogs given Osurnia were compared with 138 dogs treated with another ear medicine containing miconazole (a medicine against fungal infections), gentamicin (an antibiotic) and hydrocortisone aceponate (a corticosteroid) for five consecutive days.
Maltese: L-ewwel studju kien studju tal-UE li involva 286 kelb u kelba, li minnhom 148 kelb u kelba ngħataw Osurnia meta mqabbel mal-138 l-oħrajn li ġew trattati b'mediċina oħra tal-widnejn li fiha miconazole (mediċina kontra l-infezzjonijiet fungali), gentamicin (antibijotiku) u hydrocortisone aceponate (kortikosterojde) għal ħamest ijiem konsekuttivi.
English: The main measure of effectiveness in the EU and Japanese studies was the reduction in severity of otitis externa 28 days after initial treatment; in the US study clinical success was measured after 45 days.
Maltese: Il-kejl ewlienii tal-effikaċja fl-istudji li saru fl-UE u fil-Ġappun kien it-tnaqqis fis-severità tal-otite esterna 28 jum wara t-trattament inizjali; fl-istudju kliniku tal-Istati Uniti, is-suċċess tkejjel wara 45 jum.
English: In the US study the Osurnia treated dogs had a success rate of 65% which was significantly higher than the placebo treated dogs with a success rate of 44%.
Maltese: Fl-istudju tal-Istati Uniti, il-klieb trattati b'Osurnia urew rata ta' suċċess ta' 65% li kienet ferm ogħla minn dik fil-klieb trattati bil-plaċebo b'rata ta' suċċess ta' 44%.
English: The third active ingredient, betamethasone acetate, is a corticosteroid, a medicine that reduces inflammation and pain.
Maltese: It-tielet ingredjent attiv, betamethasone acetate, huwa kortikosterojde, mediċina li tnaqqas l-infjammazzjoni u l-uġigħ.
English: In the Japanese study Osurnia was as effective as the other medicine with 78% improvement in otitis externa in both treatment groups.
Maltese: Fl-istudju Ġappuniż, Osurnia kien effettiv daqs il-mediċina l-oħra b'titjib ta' 78% fl-otitis esterna fiżżewġ gruppi li ġew trattati.
English: Three field studies were conducted in dogs with otitis externa caused by bacterial or fungal infections, investigating the effect of treatment following cleaning out of the ear with saline solution; treatment with two doses of Osurnia, one week apart, was compared with another comparable ear medicine or with placebo (dummy treatment).
Maltese: Saru tliet studji fuq il-post fuq klieb b'otitis externa kkawżata minn infezzjonijiet batterjali jew fungali, fejn ġie investigat l-effett tat-trattament wara t-tindif tal-widna b'soluzzjoni salina; it-trattament b'żewġ dożi ta' Osurnia, b'distakk ta' ġimgħa bejniethom, tqabbel ma' mediċina tal-widnejn oħra paragunabbli jew ma' plaċebo (trattament finta).
English: Other information about Osurnia:
Maltese: Tagħrif ieħor dwar Osurnia:
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċji/ir-riskji jista' jinstab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: Osurnia must not be used if the ear drum is perforated or in dogs with generalised demodicosis (mange caused by the mite Demodex canis).
Maltese: Osurnia ma għandux jintuża jekk it-tanbur tal-widna jkun imtaqqab jew fi klieb li jkollhom demodikożi ġeneralizzata (skabbja kkawżata mill-parassita Demodex canis).
English: What is Osurnia?
Maltese: X'inhi l-Osurnia?
English: How has Osurnia been studied?
Maltese: Kif ġiet studjata Osurnia?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Osurnia on 31 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Osurnia fi 31/07/2014.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Osurnia exceed the risks for the approved indications and recommended that Osurnia be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Osurnia huma akbar mir-riskji għall-indikazzjonijiet approvati u rrakkomanda li Osurnia jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: MA (EU) Number (Invented) name
Maltese: Numru tal MA Isem (ivvintat)
English: 4 mg (1 mg/ml) 1 vial
Maltese: Il-pakkett li jmiss malprodott
English: 2002b; 42:791-797 Beltangady M et al.
Maltese: 42:791-797 Beltangady M et al.
English: Berenguer J et al. Didanosine, Lamivudine, and Efavirenz versus Zidovudine, Lamivudine, and Efavirenz for the Initial Treatment of HIV Type 1 Infection: Final Analysis (48 Weeks) of a Prospective, Randomized, Noninferiority Clinical Trial, GESIDA 3903 HIV/AIDS.
Maltese: Didanosine, Lamivudine, and Efavirenz versus Zidovudine, Lamivudine, and Efavirenz for the Initial Treatment of HIV Type 1 Infection: Final Analysis (48 Weeks) of a Prospective, Randomized, Noninferiority Clinical Trial, GESIDA 3903 HIV/AIDS.
English: J Clin Pharmacol.
Maltese: J Clin Pharmacol. 2002b;
English: Clinical Infectious Diseases 1993; 16: S26-S31
Maltese: Clinical Infectious Diseases 1993; 16:
English: Damle BD et al. Bioequivalence of two formulations of didanosine, encapsulated enteric-coated beads and buffered tablet, in healthy volunteers and HIV-infected subjects.
Maltese: Bioequivalence of two formulations of didanosine, encapsulated enteric-coated beads and buffered tablet, in healthy volunteers and HIV-infected subjects.
English: didanosine in treatment of HIV infecting were conducted using buffered tablets3,4,5,6,7,8.
Maltese: Provi kliniċi talbidu li wrew l-effikaċja ta' didanosine fil-kura ta' infezzjonijiet tal-HIV kienu saru bl-użu ta' pilloli buffered 3,4,5,6,7,8.
English: Ann Intern Med 1992: 116:562-566
Maltese: Ann Intern Med 1992: 116:562-566 7 Perry CM, Balfour JA.
English: The applicant provided literature references which showed that for the action of Didanosine, AUC is the most important parameter9,10,11,12,13.
Maltese: L-applikant ipprovda referenzi għal-letteratura li wrew li għall-azzjoni ta' Didanosine, l-AUC huwa laktar parametru importanti9,10,11,12,13.
English: 1 Note for Guidance on the investigation of bioavailability and bioequivalence (EMA/CPMP/EWP/QWP/1401/98) 2 Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms
Maltese: 1 Nota għall-Gwida dwar l-investigazzjoni ta' biodisponibilità u bioekwivalenza (EMA/CPMP/EWP/QWP/1401/98) 2 Linja Gwida dwar il-farmakokinetika u l-valutazzjoni klinika ta' forom b'rilaxx modifikat tad-doża
English: Damle BD et al. Pharmacokinetics and gamma scintigraphy evaluation of two enteric coated formulations of didanosine in healthy volunteers.
Maltese: Pharmacokinetics and gamma scintigraphy evaluation of two enteric coated formulations of didanosine in healthy volunteers.
English: 6 Drusano GL et al.
Maltese: S26-S31 6 Drusano GL et al.
English: Didanosine and associated names (Gastro-resistant capsules 400 mg) was compared to the reference product Videx EC (Gastro-resistant capsules 400 mg) in 60 healthy adults under fasting conditions.
Maltese: Didanosine u ismijiet assoċjati (Kapsuli gastro-reżistenti 400 mg) tqabbel mal-prodott ta' referenza Videx EC (kapsuli gastro-reżistenti 400 mg) f'60 adult b'saħħtu taħt kundizzjonijiet ta' sawm.
English: Chicago 2001 La Porte C et al. Pharmacokinetic interaction study of indinavir/ritonavir and the enteric-coated capsule formulation of didanosine in healthy volunteers.
Maltese: Pharmacokinetic interaction study of indinavir/ritonavir and the enteric-coated capsule formulation of didanosine in healthy volunteers.
English: The administration of the reference product with a high fat meal significantly decreases the AUC (19%) and Cmax (46%) of didanosine.
Maltese: L-għoti tal-prodott ta' referenza ma' ikla b'kontenut għoli ta' xaħam inaqqas b'mod sinifikanti lAUC (19%) u s-Cmax (46%) ta' didanosine.
English: The reference product in EU is Videx EC (200, 250 and 400 mg) hard capsules, first authorised in the United Kingdom (UK) on 19 September 2000.
Maltese: Il-prodott ta' referenza fl-UE huwa Videx EC (200, 250 u 400 mg) kapsuli ibsin, l-ewwel awtorizzati fir-Renju Unit (UK) fid-19 ta' Settembru 2000.
English: The application for Didanosine and associated names was considered under Article 10.3 of Directive 2001/83/EC in all Concerned Members States (CMSs).
Maltese: L-applikazzjoni għal Didanosine u ismijiet assoċjati kienet meqjusa taħt l-Artikolu 10.3 tadDirettiva 2001/83/EC fl-Istati Membri Kkonċernati (CMSs) kollha.
English: Schrader S et al.
Maltese: Damle BD et al.
English: 7 Perry CM, Balfour JA. Didanosine: An Update on its Antiviral Activity, Pharmacokinetic Properties and Therapeutic
Maltese: An Update on its Antiviral Activity, Pharmacokinetic Properties and Therapeutic
English: Didanosine (2', 3'-dideoxyinosine) is an inhibitor of the in vitro replication of human immunodeficiency virus (HIV) in cultured human cells and cell lines.
Maltese: Didanosine (2', 3'-dideoxyinosine) huwa inibitur tar-replikazzjoni in vitro tal-virus talimmunodefiċjenza umana (HIV) f'ċelloli u f'linji taċ-ċelloli kkulturati tal-bniedem.
English: 2002a; 54: 255-61
Maltese: Br J Clin Pharmacol. 2002a; 54: 255-61 Damle BD et al.
English: The Applicant claimed that the significant decrease observed under fed conditions for Cmax for the test product (90% CI outside the standard range) may be attributed to high inter-individual variability with respect to Cmax which was 36% in the study conducted under fed conditions.
Maltese: L-Applikant iddikjara li t-tnaqqis sinifikanti osservat taħt kundizzjonijiet mitmugħa għas-Cmax għallprodott tat-test (CI ta' 90% barra mill-firxa standard) jista' jiġi attribwit għal varjabbiltà ogħla bejn l-individwi fir-rigward tas-Cmax li kien ta' 36% fl-istudju li sar taħt kundizzjonijiet mitmugħa.
English: Considering this, the sample size that may be required to meet the standard bio-equivalence criteria would be as high as 232 subjects to obtain power of at least 80%.
Maltese: Meta wieħed iqis dan, id-daqs tal-kampjun li jista' jkun meħtieġ biex jintlaħqu l-kriterji standard ta' bijoekwivalenza jkun ta' saħansitra 232 individwu biex tinkiseb saħħa ta' mill-inqas 80%.
English: The primary pharmacokinetic parameters (Cmax and AUC) were satisfactory in the fasting study with the 90% confidence interval (CI) falling within the standard criteria of 80.00 - 125.00%.
Maltese: Riżultati tal-istudji ta' bijoekwivalenza Il-parametri farmakokinetiċi primarji (Cmax u AUC) kienu sodisfaċenti fl-istudju fi stat sajjem blintervall ta' fiduċja (CI) ta' 90% jaqa' fil-kriterji standard ta' 80.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdi mir-Renju Unit skont l-Artikolu 29(4) tadDirettiva 2001/83/KE.
English: Results of the bioequivalence studies
Maltese: A pilot comparative study.
English: The Committee acknowledged that the conventional criterion for bioequivalence for maximum plasma concentration (Cmax) was outside the 80-125% acceptability limits.
Maltese: Il-Kumitat irrikonoxxa li lkriterju konvenzjonali għal bijoekwivalenza għall-konċentrazzjoni massima fil-plasma (Cmax) kien barra l-limiti ta' aċċettabilità ta' 80-125%.
English: The pharmacokinetics data reveals that the plasma concentration (Cmax) obtained from enteric-coated capsule formulation of didanosine is about 40% lower as compared to the buffered tablet formulation.
Maltese: Id-dejta farmakokinetika turi li l-konċentrazzjoni fil-plasma (Cmax) li nkisbet mill-formulazzjoni tal-kapsula b'kisja enterika ta' didanosine hija ta' madwar 40% aktar baxxa meta mqabbla mal-formulazzjoni tal-pillola buffered.
English: Hernandez-novoa B et al. Effect of food on the antiviral activity of didanosine enteric-coated capsules: A pilot comparative study.
Maltese: Effect of food on the antiviral activity of didanosine enteric-coated capsules:
English: After didanosine enters the cell, it is enzymatically converted to dideoxyadenosine-triphosphate (ddATP), its active metabolite.
Maltese: Wara li didanosine jidħol fiċ-ċellola, jiġi enzimatikament ikkonvertit f'dideoxyadenosinetriphosphate (ddATP), il-metabolit attiv tiegħu.
English: However, both formulations are equivalent in terms of extent of absorption (i.e. AUC).
Maltese: Madankollu, iż-żewġ formulazzjonijiet huma ekwivalenti f'termini tal-firxa ta' assorbiment (jiġifieri l-AUC).
English: It is acknowledged that these results were outside the standard range of 80 - 125%; however these were within the wider acceptance criteria of 70 - 143% which may be used for highly variable drugs.
Maltese: Huwa rikonoxxut li dawn ir-riżultati kienu barra mill-firxa standard ta' 80 - 125%; madankollu dawn kienu jaqgħu fil-kriterji usa' ta' aċċettazzjoni ta' 70 - 143% li jistgħu jintużaw għal mediċini varjabbli ħafna.
English: Didanosine has to be first converted intracellularly to its active metabolite ddATP (responsible for antiviral activity) which has a significantly longer intracellular half-life (about 43 hours) as compared with plasma half-life of didanosine.
Maltese: • Sinifikat kliniku tas-Cmax b'Didanosine Didanosine l-ewwel irid jiġi kkonvertit fiċ-ċelluli fil-metabolit attiv tiegħu ddATP (responsabbli għall-attività antivirali) li għandu half-life intraċellulari ferm itwal (madwar 43 siegħa) meta mqabbel mal-half-life ta' didanosine fil-plasma.
English: In addition, ddATP inhibits HIV-reverse transcriptase by competing with deoxyadenosine-triphosphate (dATP) for binding to the enzyme's active site, preventing proviral DNA synthesis.
Maltese: Barra minn hekk, ddATP jinibixxi HIV-reverse transcriptase billi jikkompeti ma' deoxyadenosine-triphosphate (dATP) biex jintrabat mas-sit attiv tal-enzima, li jwaqqaf is-sintesi provirali tad-DNA.
English: Didanosine and associated names is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients.
Maltese: Didanosine u ismijiet assoċjati huwa indikat f'kombinazzjoni ma' mediċini antiretrovirali oħra għallkura ta' pazjenti nfettati bl-HIV-1.
English: In order to demonstrate the safety and efficacy of Didanosine and associated names in combination with other antiretroviral drugs in the treatment of HIV-1 infected patients, the application dossier was based on two single dose bioequivalence studies, one under fasting state and one under fed state.
Maltese: Valutazzjoni Sabiex juri s-sigurtà u l-effikaċja ta' Didanosine u ismijiet assoċjati f'kombinazzjoni ma' mediċini antiretrovirali oħra fil-kura ta' pazjenti infettati bl-HIV-1, id-dossier tal-applikazzjoni kien ibbażat fuq żewġ studji ta' bijoekwivalenza, b'doża unika, wieħed fi stat sajjem u wieħed fi stat mitmugħ.
English: In the fed study, the results were satisfactory in terms of extent of absorption (i.e. AUC) with 90% CI within standard range of 80.00 - 125.00%.
Maltese: Fl-istudju fi stat mitmugħ, ir-riżultati kienu sodisfaċenti f'termini tal-firxa ta' assorbiment (jiġifieri l-AUC) b'CI ta' 90% fil-firxa standard ta' 80.
English: Didanosine is intended to be administrated on en empty stomach as stated in the proposed Summary of Product Characteristics (SmPC): “Didanosine absorption is reduced in the presence of food, and hence Didanosine gastro-resistant capsules should be administrated on an empty stomach (at least 2 hours before or 2 hours after a meal)”.
Maltese: • Rakkomandazzjonijiet tad-doża għal didanosine Didanosine huwa maħsub li jingħata fuq stonku vojt kif iddikjarat fis-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) propost: “L-assorbiment ta' Didanosine jitnaqqas fil-preżenza tal-ikel, u għalhekk il-kapsuli gastro-reżistenti Didanosine għandhom jingħataw fuq stonku vojt (mill-inqas sagħtejn qabel jew sagħtejn wara ikla)”.
English: 13 Stevens RC et al. Effect of food and pharmacokinetic variability on didanosine systemic exposure in HIV-infected children.
Maltese: 10 Lopez JC et al. A Cohort Study of the Food Effect on Virological Failure and Treatment Discontinuation in Patients on HAART Containing Didanosine Enteric-Coated Capsules (FOODDIe Study).
English: In viral nucleic acid replication, incorporation of this 2', 3'-dideoxynucleoside prevents chain extension, and thereby inhibits viral replication.
Maltese: F'replikazzjoni virali tal-aċidu nuklejku, linkorporazzjoni ta' dan il-2', 3'-dideoxynucleoside timpedixxi l-estensjoni tal-katina, u b'hekk tinibixxi r-replikazzjoni virali.
English: A referral was thus triggered at the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMD(h)).
Maltese: Għalhekk inbeda riferiment fil-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u Proċeduri DeċentralizzatiUman (CMD(h)).
English: The presented data does not give evidence of in vivo dose-dumping from the formulation under fed conditions.
Maltese: Id-dejta ppreżentata mill-formulazzjoni taħt kundizzjonijiet mitmugħa ma tagħtix evidenza ta' dumping tad-doża in-vivo.
English: The applicant claimed that differences in plasma concentrations of didanosine are not of clinical relevance as such since it may not result in changes in the intracellular triphosphate concentrations.
Maltese: konċentrazzjonijiet ta' didanosine fil-plasma mhumiex ta' rilevanza klinika bħala tali peress li jistgħu ma jwasslux għal tibdil fil-konċentrazzjonijiet ta' triphosphate fiċ-ċelloli.
English: HIV Clin trials.
Maltese: L-istudju fi stat mitmugħ kien sar matul clock-stop estiż.