FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Maltese: Il-proporzjon medju ta' konċentrazzjonijiet ta' lamivudine fis-CSF/serum 2-4 sigħat wara li jittieħed mill-ħalq hu bejn wieħed u ieħor 12%.
English: • presence of skin rash; OR
Maltese: • preżenza ta' raxx tal-ġilda; JEW
English: Monitor phenytoin concentrations.
Maltese: phenytoin.
English: Hepatic impairment:
Maltese: Oġġettiv u bażi loġika:
English: In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either Kivexa once daily or abacavir 300 mg twice daily plus lamivudine 300 mg once daily, both in combination with tenofovir and a PI or an NNRTI for 48 weeks.
Maltese: Fl-istudju CAL30001, 182 pazjent b'esperjenza tat-terapija u li kellhom indeboliment viroloġiku ntgħażlu kif ġie ġie u bdew trattament b'Kivexa darba kuljum jew bi 300 mg abacavir darbtejn kuljum u 300 mg lamivudine darba kuljum, it-tnejn mgħotija flimkien ma' tenovir u PI jew NNRTI għal 48
English: Baseline CD4 category 50-100 21/40 (53%)
Maltese: Kategorija ta' CD4 50-100 fil linja bażi
English: Kivexa should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Maltese: Kivexa ma għandux jittieħed ma' xi prodott mediċinali ieħor li fih lamivudine (ara sezzjoni 4.4).
English: Data show that abacavir and lamivudine penetrate the central nervous system (CNS) and reach the cerebrospinal fluid (CSF).
Maltese: Informazzjoni disponibbli turi li abacavir u lamivudine jidħlu sew fis-sistema nervuża ċentrali (CNS)
English: A genotypic sensitivity score (GSS) has not been established by the MAH for the abacavir/lamivudine combination.
Maltese: Għadu ma ġiex stabbilit punteġġ ta' sensittività ġenotipika (GSS) mill-MAH għat-taħlita ta' abacavir/lamivudine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains abacavir 600 mg abacavir (as sulfate) and 300 mg lamivudine
Maltese: Kull pillola miksija b'rita fiha 600 mg abacavir (bħala sulfate) u 300 mg lamivudine
English: To date, there is no established biological mechanism to explain a potential increase in risk.
Maltese: Sa llum, ma hemm l-ebda mekkaniżmu bijoloġiku stabbilit biex jispjega żieda potenzjali fir-riskju.
English: Pharmacogenetic Testing
Maltese: Farmakokinetika intraċellulari
English: PHARMACEUTICAL FORM AND CONTENTS Multipack containing 90 (3 packs of 30) film-coated tablets
Maltese: Multipack li fih 90 (3 pakketti ta' 30) pillola miksija b'rita
English: (estimated hazard ratio: 2.33, 95% CI: 1.46, 3.72, p=0.0003).
Maltese: log10kopji/ml rispettivament, 95% CI -0.13, 0.38).
English: • numbness, tingly feelings in the skin (pins and needles)
Maltese: • tnemnim, sensazzjoni ta' tniggiż fil-ġilda (tniggiż)
English: The active substances in each Kivexa film-coated tablet are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
Maltese: Is-sustanzi attivi f'kull pillola miksija b'rita Kivexa huma 600 mg ta' abacavir (bħala sulfate) u 300 mg ta' lamivudine.
English: Rare: pancreatitis has been reported, but a causal relationship to abacavir treatment is uncertain
Maltese: Rari: dehret pankreatite, iżda mhux ċert jekk kinetx kawżata minn abacavir
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine .There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues: these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: Kien hemm rapporti ta' każi ta' funzjonament mitokondrjali ħażin fi trabi negattivi għall-HIV, li kienu esposti, in utero u/jew wara ttwelid, għal analogi tan-nukleosidi: dawn kienu predominantament jikkonċernaw kura b'korsijiet li fihom zidovudine.
English: Therapy-experienced patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: If you have stopped taking Kivexa because of a hypersensitivity reaction, you must NEVER AGAIN take Kivexa, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen).
Maltese: Reazzjonijiet ta' sensittività eċċessiva Kivexa fih abacavir (li huwa wkoll is-sustanza attiva f'mediċini bħal Trizivir, Triumeq u
English: Very rare: Cases of peripheral neuropathy (or paraesthesia) have been reported
Maltese: Każi ta' newropatija periferali (jew paraesteżija) ġew rappurtati
English: Proportion with HIV-1 RNA <50 copies/ml
Maltese: Proporzjon b'<50 kopja/ml ta' RNA ta' HIV-1
English: Similar reductions in HIV-1 RNA as measured by average area under the curve minus baseline were observed, indicating that the Kivexa group was non-inferior to the abacavir plus lamivudine twice daily group (AAUCMB, -1.65 log10 copies/ml versus -1.83 log10 copies/ml respectively, 95% CI -0.13, 0.38).
Maltese: Kien osservat tnaqqis jixxiebah fl-HIV-1 RNA kif imkejjel b'żona medja taħt il-kurva meta titnaqqas il-linja bażi, li jindika li l-grupp ta' Kivexa ma kienx inferjuri għall-grupp ta' abacavir mogħti flimkien ma' lamivudine darbtejn kuljum (AAUCMB, -1.65 log10 kopji/ml kontra -1.83
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Maltese: Abbażi ta' aktar minn 200 par ta' omm/tfal ikkurati għall-HIV, il-konċentrazzjonijiet fis-serum ta' lamivudine fi trabi li jerdgħu ta' ommijiet kkurati għall-HIV huma baxxi ħafna (<4% talkonċentrazzjonijiet fis-serum tal-omm) u progressivament jonqsu għal livelli li ma jistgħux jitkejlu meta trabi li jerdgħu jagħlqu 24 ġimgħa ta' età.
English: Proportion of Patients in CNA30021with <50 cps/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Maltese: Propozjon ta' Pazjenti f'CNA30021b'<50 kopja/mL fil-Ġimgħa 48 skont il-Punteġġ ta'
English: (N =192)
Maltese: NUMRU(I)
English: • fever (high temperature) and skin rash.
Maltese: • deni (temperatura għolja) u raxx fil-ġilda.
English: Abacavir and lamivudine triphosphates show significantly less affinity for host cell DNA polymerases.
Maltese: Abacavir u lamivudine triphosphates juru affinita' sostanzjalment inqas għal polymerases tad-DNA taċ-ċellula reċipjenta.
English: Diagnosis of Abacavir Hypersensitivity Reaction
Maltese: sensittività eċċessiva ta' abacavir.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Maltese: Pazjenti b'disfunzjoni tal-fwied eżistenti minn qabel, inkluż epatite attiva kronika għandhom frekwenza akbar ta' anormalitajiet fil-funzjoni tal-fwied waqt terapija antiretrovirali kombinata, u għandhom jiġu ssorveljati skont prattika standàrd.
English: Component of a multipack, not to be sold separately
Maltese: Il-kontenut ta' multipack, li m'għandhomx jinbiegħu separatament
English: ABC Hypersensitivity (including risk of reduced clinical vigilance for ABC HSR following HLA-B*5701 screening).
Maltese: Qabel tinbeda t-terapija b'abacavir, it-tobba għandhom jikkunsidraw test għal HLA-B*5701.
English: The majority of these tumours occurred at the highest abacavir dose of 330 mg/kg/day in mice and 600 mg/kg/day in rats.
Maltese: 330 mg/kg kuljum fil-ġrieden u 600 mg/kg kuljum fil-firien.
English: Common: Cough, nasal symptoms
Maltese: Komuni: Sogħla, sintomi flimnieħer
English: In any case, initiation of susceptible NRTIs should always be preferred to maintenance of lamivudine therapy.
Maltese: F'kull ċirkostanza, huwa dejjem preferit li jinbdew NRTIs suxxettibli minflok terapija kontinwa b'lamivudine.
English: The Kivexa pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions.
Maltese: Il-pakkett ta' Kivexa jinkludi Alert Card, biex tfakkar lilek u lill-istaff mediku dwar reazzjonijiet ta' sensittivita' eċċessiva.
English: Proportion of Patients in CAL30001 with <50 copies/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Maltese: Proporzjon ta' Pazjenti f'CAL30001 b'<50 kopja/mL fil-Ġimgħa 48 skont il-Punteġġ ta'
English: K65R was absent and L74V and Y115F were uncommon (≤3%).
Maltese: u Y115F ma kienux komuni (≤3%).
English: Pregnancy
Maltese: OPIOJDI
English: - The risk of virological failure with Kivexa might be higher than with other therapeutic options (see section 5.1).
Maltese: - Ir-riskju ta' falliment viroloġiku b'Kivexa jista' jkun ogħla minn dak b'għażliet terapewtiċi oħra (ara sezzjoni 5.1).
English: • In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Kivexa tablets
Maltese: • Sabiex jiġi evitat li jerġgħu jibdew abacavir, pazjenti li jkunu esperjenzaw HSR suspettat għandhom jingħataw struzzjonijiet biex jarmu l-bqija tal-pilloli tagħhom ta' Kivexa
English: The EU SPC provides detailed information and advice relating to ABC HSR
Maltese: L-SPC tal-UE jipprovdi nformazzjoni dettaljata u pariri dwar ABC
English: LIST OF EXCIPIENTS Contains sunset yellow (E110), see leaflet for further information
Maltese: Fih sunset yellow (E110), ara l-fuljett ta' tagħrif għal aktar informazzjoni
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours.
Maltese: F'pazjenti li jkunu qed jieħdu 300 mg lamivudine darba kuljum, il-half-life intraċellulari terminali ta' lamivudine-TP ġiet imtawla għal 16-19-il siegħa, meta mqabbla mal-half-life ta' lamivudine fil-plażma ta' 5-7 sigħat.
English: V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Maltese: F116Y, jikkawżaw reżistenza kbira għal abacavir.
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Maltese: Iżolati tal-Grupp O minn pazjenti li qatt ma ħadu kura antiretrovirali qabel ittestjati għal attività b'lamivudine kienu sensittivi ħafna.
English: TAMs might be selected when thymidine analogs are associated with abacavir.
Maltese: TAMs jistgħu ikunu magħżula meta analogi ta' thymidine ikunu assoċjati ma' abacavir.
English: Kivexa and similar medicines may cause side effects in unborn babies.
Maltese: Kivexa u mediċini simili jistgħu jikkawżaw effetti sekondarji fi trabi fil-ġuf.
English: LIST OF EXCIPIENTS Contains sunset yellow (E110), see package leaflet for further information
Maltese: TA' EĊĊIPJENTI Fih sunset yellow (E110), ara l-fuljett ta' tagħrif għal aktar informazzjoni
English: Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/min as necessary dose adjustment cannot be made (see section 5.2).
Maltese: Kivexa m'huwiex rakkomandat għal użu f'pazjenti b'eliminazzjoni ta' krejatinina < 50 ml/min peress li ma jistax isir l-aġġustament meħtieġ fid-doża (ara s-sezzjoni 5.2).
English: Your methadone dose may need to be changed.
Maltese: Il-probabbilta' ta' interazzjonijiet metaboliċi ta'
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Maltese: Mediċini kontra l-vajrus għall-użu sistemiku, mediċini kontra l-vajrus għall-kura ta' infezzjonijiet b'HIV, kombinazzjonijiet.
English: Tablet Coating
Maltese: Komposti ta' retinojd
English: The proportion of treatment-experienced patients in the CAL30001 study with HIVRNA <50 copies/mL at Week 48 by genotypic sensitivity score in optimized background therapy (OBT) are tabulated The impact of major IAS-USA defined mutations to abacavir or lamivudine and multi-NRTI resistance associated mutations to the number of baseline mutations on response was also evaluated.
Maltese: CAL30001 b'<50 kopja/mL ta' RNA tal-HIV fil-Ġimgħa 48 skont il-punteġġ ta' sensittività ġenotipika bl-aħjar terapija fl-isfond (OBT) huma miġburin f'tabella.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Maltese: • raxx fil-ġilda, li tista' tifforma bżieżaq u jidhru qishom miri żgħar (tikek skuri fin-nofs imdawwra b'żona aktar pallida, b'ċirku skur madwar it-tarf) (eritema multiforme)
English: Patients were stratified at screening based on plasma HIV-1 RNA levels < 100,000 and ≥ 100,000 copies/mL.
Maltese: Il-pazjenti kienu magħżula b'eżami fejn ġew maqsuma fi klassijiet fuq bażi tal-livelli ta' RNA ta' HIV-1 < 100,000 u ≥ 100,000 kopja/mL fil-plażma.
English: The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
Maltese: L-esponiment sistemiku għall-livell ta' bla effett fil-ġrieden u fil-firien kienet ekwivalenti għal minn 3 u 7 darbiet aktar mill-esponiment sistemiku uman li jkun hemm waqt it-terapija.
English: Elderly
Maltese: NRTI
English: Active renal secretion of lamivudine in the urine is mediated through organic cation transporters (OCTs); co-administration of lamivudine with OCT inhibitors may increase lamivudine exposure.
Maltese: Tneħħija attiva ta' lamivudine mill-kliewi għal ġol-awrina hija medjata permezz ta' trasportaturi ta' katjoni organiċi (OCTs); l-għoti ta' lamivudine ma' impedituri ta' OCT jista' jżid l-esponiment għal lamivudine.
English: Both abacavir and lamivudine have been shown to inhibit replication of laboratory strains and clinical isolates of HIV in a number of cell types, including transformed T cell lines, monocyte/macrophage derived lines and primary cultures of activated peripheral blood lymphocytes (PBLs) and monocyte/macrophages.
Maltese: Kemm abacavir kif ukoll lamivudine ntwerew li jimpedixxu r-replikazzjoni ta' razez tal-laboratorju u tal-iżolati kliniċi tal-HIV f'numru ta' tipi ta' ċelluli, li jinkludu linji ta' ċelluli T mibdula, linji ġejjin minn monoċiti/makrofaġi u kolturi primarji ta' limfoċiti tad-demm periferali (PBLs) u monoċiti/makrofaġi attivati.
English: The recommended dose of Kivexa for adults, adolescents and children weighing 25 kg or more is one tablet once a day.
Maltese: Id-doża rakkomandata ta' Kivexa għall-adulti, adoloxxenti u għal tfal li jiżnu 25 kg jew aktar hija pillola waħda kuljum.
English: Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Maltese: Abacavir huwa primarjament metabolizzat mill-fwied u bejn wieħed u ieħor 2% ta' abacavir jitneħħa mingħajr ma jinbidel fl-awrina.
English: These symptoms usually resolve upon discontinuation of abacavir.
Maltese: Dawn is-sintomi normalment ma jibqgħux jidhru meta jitwaqqaf abacavir.
English: Phenotypic resistance to abacavir requires M184V with at least one other abacavir-selected mutation, or M184V with multiple TAMs.
Maltese: Reżistenza finotipika għal abacavir għanda bżonn M184V b'almenu mutazzjoni waħda oħra magħżula għal abacavir, jew M184V b'ħafna TAMs.
English: Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and in the liver, urinary bladder, lymph nodes and the subcutis of females.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu It-twissijiet u prekawzjonijiet speċjali dwar abacavir u lamivudine huma inklużi f'din is-sezzjoni.
English: No pharmacokinetic data are available in patients over 65 years of age.
Maltese: M'hemmx tagħrif farmakokinetiku dwar pazjenti li għandhom ‘l fuq minn 65 sena.
English: Drugs by Therapeutic Area Interaction Geometric mean change (%) (Possible mechanism)
Maltese: Interazzjoni Tibdil ġeometriku medju (%)
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite kronika B jew C u li jkunu fuq terapija kombinata retrovirali jkunu qegħdin f'riskju ogħla ta' reazzjonijiet avversi fil-fwied li jistgħu ikunu serji u potenzjalment fatali.
English: Drug Interactions:
Maltese: Kategorija farmakoterapewtika:
English: Anyone taking Kivexa could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Kivexa.
Maltese: hypersensitivitiy reaction) għal abacavir, li huwa riskju identifikat importanti:
English: Neither abacavir nor lamivudine were mutagenic in bacterial tests, but consistent with other nucleoside analogues, they inhibit cellular DNA replication in in vitro mammalian tests such as the mouse lymphoma assay.
Maltese: Mutaġeniċità u karċinoġeniċità La abacavir u lanqas lamivudine ma kienu mutaġeniċi f'testijiet batteriċi, iżda bħal ma jiġri b'analogi tan-nukleosidi oħra, dawn jimpedixxu r-replikazzjoni tad-DNA taċ-ċelluli fit-testijiet in vitro fuq mammali bħall-analiżi tal-limfoma fil-ġrieden.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Maltese: Eżempji rilevanti huma retinite ċitomegalovirus, infezzjonjijiet mikobatterjali ġeneralizzati jew fokali,
English: Additionally, autoinduction of abacavir metabolism or induction of the metabolism of other medicinal products hepatically metabolised has not been observed in man.
Maltese: Minbarra hekk, awto-induzzjoni tal-metaboliżmu ta' abacavir jew l-induzzjoni tal-metaboliżmu ta' xi prodotti mediċinali oħra ma ġewx osservati fil-bniedem.
English: Abacavir hypersensitivity reactions
Maltese: Każijiet studjati ta' sensittività eċċessiva
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44%.
Maltese: fil-plażma ta' bejn 30 sa 44%.
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul terapija antiretrovirali (ara sezzjoni 4.4).
English: • sensation of weakness in the limbs
Maltese: • sensazzjoni ta' debbulizza fir-riġlejn u fid-dirgħajn
English: The mean half-life of abacavir is about 1.5 hours.
Maltese: Il-medja tal-half-life ta' abacavir hija madwar 1.5 sigħat.
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Maltese: Dijanjosi klinika ta' suspett ta' sensittività eċċessiva għal ABC tibqa' l-bażi għat-teħid ta' deċiżjonijiet kliniċi.
English: Pharmacokinetic data has been obtained for abacavir and lamivudine separately.
Maltese: Tagħrif farmakokinetiku inkiseb dwar lamivudine u abacavir weħidhom.
English: 1 Major IAS-USA defined mutations to Abacavir or Lamivudine and multi-NRTI resistance associated mutations
Maltese: 1 Mutazzjonijiet prinċipali ddefiniti minn IAS-USA għal Abacavir jew Lamivudine u mutazzjonijiet assoċjati ma' reżistenza għal diversi NRTIs
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Maltese: Għalkemm l-etjoloġija hi meqjusa li tkun ġejja minn ħafna fatturi (inklużi użu ta' sterojdi, konsum ta' alkoħol, immunosoppressjoni qawwija, indiċi ogħla ta' piż tal-ġisem), każi ta'osteonekrożi ġew rappurtati partikularment f'pazjenti bil-marda HIV avvanzata u/jew esponiment fit-tul għal TARK.
English: 3705 LZ Zeist
Maltese: M184V waħdu 75
English: 5.1 Pharmacodynamic properties
Maltese: .1 Propjetajiet farmakodinamiċi
English: Osteonecrosis
Maltese: Anġjoedema
English: ANTIMYCOBACTERIALS Rifampicin/Abacavir
Maltese: Rifampicin/Abacavir
English: If you have stopped taking Kivexa
Maltese: RETINOJDI Komposti ta' retinojd
English: These metabolites are excreted in the urine.
Maltese: newtropenja) u disturbi ta' metaboliżmu (iperlaktejtimja, iperlajpejżimja).
English: RETINOIDS Retinoid compounds (e.g. isotretinoin)/Abacavir
Maltese: (eż. isotretinoin)/Abacavir
English: The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy and confer high-level resistance to lamivudine.
Maltese: Il-varjanti ta' M184V jew M184I issibhom f'pazjenti nfettati bl-HIV-1 li jingħataw trattament antiretrovirali li fih lamivudine u jkollhom reżistenza ta' livell għoli għal lamivudine.
English: Two mutations conferred a 7- to 8-fold change in abacavir susceptibility and combinations of three mutations were required to confer more than an 8-fold change in susceptibility.
Maltese: Żewġ mutazzjonijiet taw bidla ta' 7 sa 8 darbiet fis-suxxettibiltà ta' abacavir u taħlita ta' tliet mutazzjonijiet kienu jinħtieġu biex ikun hemm bidla ta' iktar minn 8 darbiet fissuxxettibiltà.
English: Such infections may have been “silent” and not detected by the weak immune system before treatment was started.
Maltese: Infezzjonijiet bħal dawn jistgħu jkunu “mingħajr sintomi” u mhux skoperti mis-sistema immuni dgħajfa qabel ma tinbeda lkura.
English: However, some patients with a suspected ABC hypersensitivity reaction may not have the HLA-B*5701 allele.
Maltese: Madankollu, xi pazjenti b'suspett ta' reazzjoni ta' sensittività eċċessiva għal ABC jista' ma jkollomx l-allel HLA-B*5701.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: EU/1/08/502/001
Maltese: FIS-SUQ EU/1/08/502/001
English: 28065 Cerano (NO) Italy
Maltese: 28065 Cerano (NO)
English: Adults > 30 years
Maltese: Adulti > 30 sena
English: Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux France
Maltese: Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux Franza
English: Date of first authorisation: 6 March 2009 Date of latest renewal: 20 February 2019
Maltese: 6 Marzu 2009 Data tal-aħħar tiġdid: 20 Frar 2019
English: This should take approximately 30 minutes.
Maltese: Dan għandu jieħu madwar 30 minuta.
English: • 1 Filter for MEPACT
Maltese: • 1 filtru għal MEPACT
English: Frequency category Adverse reaction (preferred term)
Maltese: Reazzjoni avversa (terminoloġija preferita)
English: It can also be administered as an outpatient.
Maltese: Jista' jiġi amministrat bħala outpatient.
English: • 1 vial of MEPACT (mifamurtide)
Maltese: • 1 kunjett ta' MEPACT (mifamurtide)
English: Reconstituted suspension
Maltese: Suspensjoni rikonstitwita
English: Specific studies addressing reproductive function, perinatal toxicity and carcinogenic potential have not been performed.
Maltese: Ma sarux studji speċifiċi li jindirizzaw il-funzjoni riproduttiva, tossiċità perinatali u potenzjal karċinoġeniku.
English: • Filter for MEPACT
Maltese: • Filtru għal MEPACT
English: The second episode involved multiple grand mal seizures over the course of days.
Maltese: It-tieni episodju involva aċċessjonijiet grand mal multipli matul il-kors ta' ġranet.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoloskelettriċi u tat-tessuti konnettivi
English: Mifamurtide (muramyl tripeptide phosphatidyl ethanolamine, MTP-PE) is a fully synthetic derivative of muramyl dipeptide (MDP), the smallest naturally-occurring immune stimulatory component of cell walls from Mycobacterium sp.
Maltese: Mifamurtide (muramyl tripeptide phosphatidyl ethanolamine, MTP-PE) huwa derivattiv kompletament sintetiku ta' muramyl dipeptide (MDP), l-iktar komponent stimulatorju immuni żgħir li jseħħ naturalment ta' ċelluli tal-ħitan minn Mycobacterium sp.
English: MEPACT contains sodium
Maltese: MEPACT fih is-sodium
English: Adverse reactions are classified according to system organ class and frequency.
Maltese: Reazzjonijiet avversi huma kklassifikati skond is-sistema tal-klassi tal-organi u frekwenza.
English: Embryotoxic effects were observed only at maternal toxic levels.
Maltese: Effetti ebriju-tossiċi kienu osservati biss f'livelli materni tossiċi.