FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of pancreatitis have occurred rarely in patients treated with abacavir, lamivudine and zidovudine.
Maltese: Każi ta' pankreatite seħħu rarament f'pazjenti fuq kura ta' abacavir, lamivudine u zidovudine.
English: Cross-resistance between abacavir, lamivudine or zidovudine and antiretrovirals from other classes e.g. PIs or NNRTIs is unlikely.
Maltese: Cross-resistance bejn abacavir, lamivudine jew zidovudine u antiretrovirali minn klassijiet oħra e.ż PIs jew NNRTIs, mhix probabbli.
English: Rare: pure red cell aplasia Very rare: aplastic anaemia
Maltese: Rari ħafna: anemija aplastika.
English: Intravenous studies with abacavir, lamivudine and zidovudine showed that the mean apparent volume of distribution is 0.8, 1.3 and 1.6 l/kg respectively.
Maltese: distribuzzjoni hu 0.8, 1.3 u 1.6 l/kg rispettivament.
English: Clinical studies have shown that there are no clinically significant interactions between abacavir, lamivudine and zidovudine.
Maltese: Studji kliniċi wrew li m'hemm l ebda interazzjonijiet sinifikanti b'mod kliniku bejn abacavir, lamivudine u zidovudine.
English: Adverse reactions have been reported with abacavir, lamivudine and zidovudine used separately or in combination for therapy of HIV disease.
Maltese: Jeżistu rapporti ta' reazzjonijiet avversi għal abacavir, lamivudine u zidovudine kemm meta ntużaw separatament u kemm flimkien fit-terapija għall-marda HIV.
English: In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V, V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Maltese: Barra minn hekk, il-kumpless ta' dħul 69 jew il-mutazzjoni Q151M, li l-biċċa l-kbira ssibhom ma' A62V, V751, F77L u F116Y, jagħmlu reżistenza kbira għal abacavir.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Maltese: jwassal għal tnaqqis fleffikaċja taż-żewġ mediċini.
English: Patients co-infected with hepatitis B or C virus
Maltese: Pazjenti infettati wkoll bil-vajrus ta' l-epatite B jew C:
English: • sodium valproate, to treat epilepsy
Maltese: • telf tal-aptit, tnaqqis fil-piż
English: In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting.
Maltese: Kemm verament kien hemm penetrazzjoni ta' lamivudine fis-CNS u r-relazzjoni ta' dan ma' xi effikaċja klinika mhux magħruf.
English: • amphotericin or co-trimoxazole, to treat fungal and bacterial infections
Maltese: • amphotericin jew co-trimoxazole, biex jikkuraw infezzjonijiet b'mikrobi u fungus
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5 - 10 %) and low plasma binding.
Maltese: lamivudine hi żgħira minħabba l-ammont limitat ta' metaboliżmu tal-fwied (5-10 %) u tagħqid ftit ta' plażma.
English: Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine (see section 4.8).
Maltese: Kura, speċjalment terapija akuta, flimkien ma' prodotti mediċinali li jistgħu jkunu nefrotossiċi jew mijelosoppressivi (eż. pentamidine sistemiku, dapsone, pyrimethamine, co-trimoxazole,
English: PHARMACEUTICAL FORM AND CONTENTS 60 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
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/wild ikkurati għall-HIV, il-konċentrazzjonijiet ta' lamivudine fis-serum fi trabi mreddgħin ta' ommijiet ikkurati għal HIV huma baxxi ħafna (< 4% tal-konċentrazzjonijiet fis-serum maternali) u jonqsu progressivament għal livelli li ma jiġux rilevati meta trabi mreddgħin jilħqu l-etàta' 24 ġimgħa.
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66 % of the dose excreted in the urine.
Maltese: Il-passaġġi ewlenin ta' metaboliżmu fil-bniedem huma b'alkoħol dehydrogenase u bi glukurinidazzjoni biex jipproduċu il-5'-aċidu carboxylic u l
English: If Trizivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see Zeffix SmPC).
Maltese: Jekk Trizivir jitwaqqaf f'pazjenti ko-infettati bil-virus ta' l-epatite B, hu rakkomandat monitoraġġ perjodiku b'testijiet għall-funzjonament tal-fwied u markers tar-replikazzjoni ta' l-HBV, għax it twaqqif ta' lamivudine jista' jirriżulta f'aggravazjoni akuta ta' l-epatite (ara SmPC ta' Zeffix).
English: Clinically significant reduction of susceptibility to abacavir has been demonstrated in clinical isolates of patients with uncontrolled viral replication, who have been pre-treated with and are resistant to other nucleoside inhibitors.
Maltese: Tnaqqis sustanzjali klinikament fis-suxxettibilita' ta' abacavir deher f'iżolati kliniċi ta' pazjenti, b'replikazzjoni mingħajr kontroll tal-virus, li kienu ttrattati minn qabel bi u huma resistenti għal nucleoside inhibitors oħra.
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Maltese: L-istudju wera li feti esposti in utero għat-taħlita spiċċaw b'livell ogħla ta' analogi nukleosidi-inkorporazzjoni ta' DNA f'organi multipli tal-feti, u wera sinjali ta' aktar tqassir ta' telomere minn dawk esposti biss għal zidovudine.
English: The presence of M184V with K65R does give rise to crossresistance between abacavir, tenofovir, didanosine and lamivudine, and M184V with L74V gives rise to cross-resistance between abacavir, didanosine and lamivudine.
Maltese: Zidovudine, didanosine, stavudine u tenofovir iżżommu l-attivita' antiretrovirali tagħhom kontra dawn it-tipi differenti ta' HIV-1.Il-preżenza ta' M184V ma' K65R tagħmel cross-resistance ma' abacavir, tenofovir, didanosine u lamivudine.Il-preżenza ta' M184V ma'
English: • dapsone, to prevent pneumonia and treat skin infections
Maltese: • dapsone, biex jipprevjeni l-pnemownja u tikkura infezzjonijiet fil-ġilda
English: Rare: anorexia, lactic acidosis in the absence of hypoxaemia
Maltese: Aċidożi lattika Rari: anoressija, aċidożi lattika fl-assenza ta' nuqqas ta' ossiġnu
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV, b'defiċjenza immunitarja severa fiż-żmien li tkun inbdiet it-terapija antiretrovirali kombinata (CART), jista' jkun hemm reazzjoni infjammatorja għall-mikrobi opportunistiċi moħbija jew residwi.
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Maltese: L-użu ta' ribavirin flimkien ma' zidovudine mhuwiex irrakkomandat minħabba żieda fir-risku ta' anemija (ara sezzjoni 4.4).
English: It is important to take Trizivir regularly, because if you take it at irregular intervals it may not continue to work against the HIV infection, and you may be more likely to have a hypersensitivity reaction.
Maltese: Hu importanti li tieħu Trizivir regolarment, għax jekk dan ma tagħmlux jista' ma jibqax effettiv kontra l-infezzjoni tal-HIV, u jista' jiżdiedlek ir-riskju ta' reazzjonijiet ta' sensittività eċċessiva.
English: After a median follow-up of 144 weeks, 25 % of subjects on the ZDV/3TC/ABC/EFV arm and 26 % on the ZDV/3TC/EFV arm were categorised as having virological failure.
Maltese: Wara li ġew segwiti għall-perijodu medjan ta' 144 ġimgħa, 25 % tas-suġġetti fuq ilfergħa ZDV/3TCABC/EFV u 26 % fuq il-fergħa
English: • chest pain; disease of the heart muscle (cardiomyopathy)
Maltese: • uġigħ fis-sider; mard tal-muskolu tal-qalb (kardjomijopatija)
English: In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Maltese: F'pazjenti bi ħsara ħafifa tal-fwied (punteġġ Child-Pugh 5-6) huwa meħtieġ monitoraġġ mill-qrib, inkluż monitoraġġ ta' livelli tal-plażma ta'
English: • itching
Maltese: • tnemnim
English: • hypersensitivity reaction
Maltese: • reazzjoni ta' sensittivita' eċċessiva
English: In patients with high viral load (> 100,000 copies/ml) choice of therapy needs special consideration (see section 5.1).
Maltese: F'pazjenti bi piż virali għoli (> 100,000 kopji/ml) l-għażla tat-terapija teħtieġ kunsiderazzjoni speċjali (ara t-taqsima 5.1).
English: TRIZIVIR TABLETS ALERT CARD (blister and bottle pack)
Maltese: TRIZIVIR (folja u pakkett tal-flixkun)
English: Abacavir, lamivudine and zidovudine triphosphates show significantly less affinity for host cell DNA polymerases.
Maltese: Abacavir, lamivudine u zidovudine jiġu assorbiti malajr u tajjeb mill-apparat gastro-intestinali wara li jittieħdu mill-ħalq.
English: Trizivir is not recommended in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Trizivir sakemm il-pazjenti ma jkollux indeboliment talkliewi (Ara Sezzjoni 4.2).
English: As dose adjustments of lamivudine and zidovudine may be necessary it is recommended that separate preparations of abacavir, lamivudine and zidovudine be administered to patients with reduced renal function (creatinine clearance ≤ 50 ml/min).
Maltese: Billi jista' jkun hemm ħtieġa għal aġġustament fid-doża hu rakkomandat li preparazzjinijiet separati ta' abacavir, lamivudine u zidovudine jingħataw lil pazjenti b'funzjonament tal-kliewi imnaqqas (tneħħija ta' kreatinina ≤ 50 ml/min).
English: Common: raised blood levels of liver enzymes and bilirubin Rare: liver disorders such as severe hepatomegaly with steatosis,
Maltese: Mhux komuni: uġigħ mill-gass fl-istonku Rari:pigmentazzjoni tal-mukoża tal-ħalq,
English: NAME OF THE MEDICINAL PRODUCT TRIZIVIR 300 mg/150 mg/300 mg film-coated tablets
Maltese: TRIZIVIR pilloli ta' 300 mg/150 mg/300 mg miksijin b'rita
English: Single doses up to 1,200 mg and daily doses up to 1,800 mg of abacavir have been administered to patients in clinical studies.
Maltese: Dożi waħdanin ta' mhux aktar minn 1,200 mg u dożi ta' kuljum ta' mhux aktar minn 1,800 mg ta' abacavirġew mogħtija lil pazjenti fi studji kliniċi.
English: Caution should be exercised when administering zidovudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Maltese: Għandha tingħata attenzjoni meta pazjent jingħata zidovudine (partikolarment lil nisa ħoxnin) li jbatu bl-epatomegalija, epatite jew fatturi oħra ta' riskju magħruf għal disturbi tal-fwied u steatożi tal-fwied (inklużi ċerti prodotti mediċinali u alkoħol).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL x 60 FILM-COATED TABLETS
Maltese: PAKKETT B'FOLJI x 60 PILLOLA MIKSIJA B'RITA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARTON x 60 FILM-COATED TABLETS
Maltese: TIKKETTA TAL-FLIXKUN x 60 PILLOLA MIKSIJA B'RITA
English: Uncommon: thrombocytopenia and pancytopenia with marrow hypoplasia
Maltese: Rari: żieda fl-amylase tasserum u pankrejatite
English: • vincristine, vinblastine or doxorubicin, to treat cancer Tell your doctor if you're taking any of these.
Maltese: • vincristine, vinblastine jew doxorubicin, biex jikkuraw il-kanċer.
English: Phenotypic resistance to abacavir requires M184V with at least one other abacavir-selected mutation, or M184V with multiple TAMs.
Maltese: Reżistenza phenotypic għal abacavir għanda bżonn M184V b'almenu mutazzjoni waħda oħra magħżula għal abacavir, jew M184V b'ħafna TAMs.
English: Management of ABC HSR reaction
Maltese: Immaniġgjar ta' reazzjoni ABC
English: They are blue/green and capsuleshaped and are provided in blister packs containing 60 tablets or bottles containing 60 tablets with child-resistant tops.
Maltese: Huma ta' lewn blu/aħdar u forma ta' kapsula u ssibhom ġo folji blister f'pakketti ta' 60 pillola jew fi fliexken li ma jistgħux jinfetħu mit-tfal u li jkun fihom 60 pillola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/156/002 - opaque white PCTFE/PVC-Al Blister pack (60 Tablets) EU/1/00/156/003 -Bottle pack (60 Tablets)
Maltese: EU/1/00/156/002 - Pakkett b'folji blister tal-PCTFE/PVC-Al (60
English: An effect of abacavir is observed on zidovudine (Cmax reduced with 20 %) and on lamivudine (Cmax reduced with 35 %).
Maltese: 20 %) u fuq lamivudine (Cmax imnaqqas b'35 %).
English: Common: rash, alopecia
Maltese: Komuni: tqallih, rimettar, dijarea
English: If you forget to take Trizivir
Maltese: Oqgħod attent ħafna bi Trizivir
English: Trizivir is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults (see sections 4.4 and 5.1).
Maltese: Immunodefiċjenza fil-Bniedem (HIV)(ara sezzjonijiet 4.4 u 5
English: Similar reactions have also occurred infrequently after restarting abacavir in patients who had only one of the key symptoms of hypersensitivity (see above) prior to stopping abacavir; and on very rare occasions have also been seen in patients who have restarted therapy with no preceding symptoms of a HSR (i.e., patients previously considered to be abacavir tolerant).
Maltese: Reazzjonijiet simili seħħew ukoll b'mod mhux frekwenti wara li abacavir reġa' inbeda f'pazjenti li kellhom biss wieħed mis-sintomi ewlenin ta' sensittività eċċessiva (ara hawn fuq) qabel ma waqqfu abacavir; u f'okkażjonijiet rari ħafna dehru wkoll f'pazjenti li reġgħu bdew it-terapija mingħajr ma kien kellhom ebda sintomu preċedenti ta' HSR (jiġifieri pazjenti li qabel kienu kunsidrati li kienujittolleraw abacavir).
English: • irritated or runny nose
Maltese: • flissjoni jew irritazzjoni fl-imnieħer
English: Trizivir contains abacavir, lamivudine and zidovudine, therefore any interactions identified for these individually are relevant to Trizivir.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Trizivir fih abacavir, lamivudine u zidovudine, għalhekk kwalunkwe interazzjonijiet identifikati għal dawn il-mediċini individwali huma rilevanti għal Trizivir.
English: • fever (high temperature) and skin rash
Maltese: • deni (temperatura għolja) u raxx fil-ġilda
English: Abacavir and its metabolites are excreted into the milk of lactating rats.
Maltese: Abacavir jiġi metabolizzat l-aktar mill-fwied.
English: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia)
Maltese: • falliment tal-mudullun li jipproduċi celluli ħomor jew bojod ġodda (aplastic anemia).
English: The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy and confers 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 jagħmlu reżistenza ta' livell għoli għal lamivudine.
English: • muscle weakness
Maltese: • tħossok bla nifs
English: MISCELLANEOUS Ethanol/Abacavir (0.7 g/kg single dose/600mg single dose)
Maltese: (doża waħda ta' 0.7 g/kg/doża waħda ta' 600mg)
English: After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26 % of subjects on the ZDV/3TC/ABC arm, 16 % on the ZDV/3TC/EFV arm and 13 % on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml).
Maltese: ZDV/3TC/ABC instabet li kienet inferjuri viroloġikament għaż-żewġ friegħi l-oħra irrespettivament mill-piż virali tal-linja bażi (<jew> 100,000 kopja kull ml), b'26 % tas-suġġetti fuq il-fergħa
English: Trizivir is contraindicated in patients with end-stage renal disease (see section 4.3).
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul terapija antiretrovirali (ara sezzjoni 4.4).
English: IMPORTANT: for information on abacavir hypersensitivity see the information below, under the Description of selected adverse reactions
Maltese: IMPORTANTI: għaltagħrif dwar sensittività eċċessiva għal abacavir, ara l-informazzjoni hawn taħt, taħt id-Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: After administration of a single dose of 200 mg zidovudine to HIV-infected women, the mean concentration of zidovudine was similar in human milk and serum.
Maltese: Wara l-għoti ta' doża waħda ta' 200 mg zidovudine lil nisa infettati bl-HIV, il-konċentrazzjoni medja ta' zidovudine kienet simili fil-ħalib u fis-serum tal-bniedem.
English: Likewise, neither lamivudine nor zidovudine had any effect on fertility.
Maltese: Bl-istess mod, la lamivudine u l-anqas zidovudine ma kellhom xi effett fuq fertilita'.
English: About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLAB*5701 gene developed a hypersensitivity reaction.
Maltese: Bejn wieħed u ieħor minn 3 sa 4 pazjenti minn kull 100 li ngħataw abacavir fi studju kliniku li ma kellhomx il-ġene HLA-B*5701 żviluppaw reazzjoni ta' sensittivita' eċċessiva
English: Your doctor may need to monitor you while you are taking Trizivir.
Maltese: Għad ma teżistix xi esperjenza ta' doża eċċessiva ta' Trizivir.
English: Other symptoms include:
Maltese: Jekk ikollok xi sintomi ta' nfezzjoni waqt li tkun qed tieħu Trizivir:
English: A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at humanequivalent exposures.
Maltese: ġol-plaċenta f'xadini qabbel zidovudine waħdu ma' taħlita ta' zidovudine u lamivudine f'esponimenti ekwivalenti fil-bniedem.
English: As dose adjustment of Trizivir is not possible, separate preparations of abacavir, lamivudine and zidovudine should be used.
Maltese: Billi aġġustament fid-doża ta' Trizivir mhux possibbli, għandhom jintużaw preparazzjonijiet separati ta' abacavir, lamivudine u zidovudine.
English: • headache
Maltese: • dijarreja
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi ssuspettati wara l-awtorizzazzjoni talprodott mediċinali.
English: This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar doses.
Maltese: Din it-taħlita fissa tissostitwixxi t-tlett komponenti (abacavir, lamivudine u zidovudine) li jintużaw separatament f'dożi simili.
English: In a meta-analysis of six clinical trials, TAMs were not selected by regimens containing abacavir without zidovudine (0/127), but were selected by regimens containing abacavir and the thymidine analogue zidovudine
Maltese: F'meta-analiżi ta' sitt studji kliniċi, it-TAMs ma kienux magħżula minn sistemi ta' kura li fihom abacavir mingħajr zidovudine (0/127), imma kienu magħżula minn sistemi ta' kura li fihom abacavir u l-analogu ta' thymidine zidovudine (22/86, 26 %).
English: • stomach ache
Maltese: • tħossok sturdut
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Maltese: Fi tfal li ommijiethom kienu ħadu NRTIs waqt it-tqala, il-benefiċċju mill-protezzjoni kontra l-HIV kien akbar mir-riskju tal-effetti sekondarji.
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in the rabbit at relatively low systemic exposures, comparable to those achieved in humans.
Maltese: Lamivudine ma kienx teratoġeniku fi studji fuq annimali iżda kien hemm indikazzjonijiet ta' żieda fl-imwiet embrjoniċi fil-fniek b'esponimenti sistemiċi relattivament baxxi, meta mqabbla ma' dawk li jilħaq il-bniedem.
English: Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Trizivir.
Maltese: Paramemetri ematoloġiċi għandhom għalhekk ikunu monitorjati sew (ara sezzjoni 4.3) f'pazjenti fuq Trizivir.
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU) Isem ivvintat Qawwa
English: Immediate Packaging Pack size
Maltese: Il-pakkett li jmiss mal-prodott
English: Content
Maltese: Dożaġġ
English: Difference (95% CI) vs placebo
Maltese: Differenza (95% CI) vs plaċebo
English: * p < 0.001 vs Placebo;°p = 0.002 vs Placebo
Maltese: * p< 0.001 vs Plaċebo; ° p = 0.002 vs Plaċebo
English: IPSS Total score
Maltese: IPSS Skor totali
English: Packs of 5, 10, 20, 30, 50, 90, 100 capsules.
Maltese: Pakketti ta' 5, 10, 20, 30, 50, 90, 100 kapsula.
English: Silodosin Placebo
Maltese: Silodosin Plaċebo
English: IPSS Irritative symptoms
Maltese: IPSS Sintomi irritattivi
English: Ελλάδα ΒΙΑΝΕΞ Α.Ε.
Maltese: Sewqan u tħaddim ta' magni
English: Capsule content Starch, pregelatinised (maize) Mannitol (E421) Magnesium stearate Sodium laurilsulfate
Maltese: Kontenut tal-kapsula Starch, pregelatinised (maize) Mannitol (E421) Magnesium stearate Sodium laurilsulfate
English: 5 hard capsules 10 hard capsules 20 hard capsules 30 hard capsules 50 hard capsules 90 hard capsules 100 hard capsules
Maltese: 5 kapsuli ibsin 10 kapsuli ibsin 20 kapsula iebsa 30 kapsula iebsa 50 kapsula iebsa 90 kapsula iebsa 100 kapsula iebsa
English: ZAMBON nv-sa Tél/Tel: + 32 2 777 02 00
Maltese: Luxembourg/Luxemburg ZAMBON nv-sa Tél/Tel: + 32 2 777 02 00
English: Silodyx is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules.
Maltese: Silodyx jiġi f'pakketti ta' 5, 10, 20, 30, 50, 90, 100 kapsula.
English: The active substance is silodosin.
Maltese: Is-sustanza attiva hija silodosin.
English: Urticaria1 Drug eruption1
Maltese: Takikardija1 Palpitazzjonijiet1
English: Baseline value (± SD)
Maltese: Valur tal-linja bażi (± SD)
English: Date of first authorisation: 29/01/2010 Date of latest renewal: 18/09/2014
Maltese: Data tal-aħħar tiġdid: 18/09/2014
English: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Maltese: Kura tas-sinjali u s-sintomi ta' iperplasija beninna tal-prostata (benign prostatic hyperplasia, BPH) f'irġiel adulti.
English: Takeda Italia S.p.A. Tel: +39 06 502601
Maltese: Tel: + 39 06 502601
English: Almirall, S.A. Tel: +34 93 291 30 00
Maltese: Tel: +34 93 291 30 00
English: Common Uncommon Rare
Maltese: Komuni ħafna Komuni
English: Exposure to the main metabolites, silodosin glucuronide and KMD3293, was also increased.
Maltese: Żdied ukoll l-esponiment għall-metaboliti prinċipali, silodosin glucuronide u KMD-3293.
English: White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm).
Maltese: Kapsula iebsa bajda, opaka tal-ġelatina, daqs 0 (madwar 21.7 x 7.6 mm).
English: Silodyx 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Maltese: Silodyx 8 mg huma kapsuli ibsin tal-ġelatina, bojod, opaki, daqs 0 (madwar 21.7 x 7.6 mm).