FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq ilportal web Ewropew tal-mediċini.
English: Co-administration with didanosine due to the potential for serious and/or life-threatening events notably lactic acidosis, liver function abnormalities, pancreatitis and peripheral neuropathy (see sections 4.4 and 4.5).
Maltese: L-għoti flimkien ma' didanosine minħabba l-potenzjal għal avvenimenti serji u/jew ta' periklu għallħajja b'mod partikolari aċidożi lattika, anormalitajiet fil-funzjoni tal-fwied, pankreatite u newropatija periferali (ara sezzjonijiet 4.4 u 4.5).
English: Zerit 30 mg hard capsules
Maltese: Zerit 30 mg kapsula iebsa
English: Zerit 30 mg hard capsules Each hard capsule contains 30 mg of stavudine.
Maltese: Zerit 30 mg kapsula iebsa Kull kapsula iebsa fiha 30 mg ta' stavudine.
English: Unchanged stavudine was the major drug-related component in total plasma radioactivity circulating after an oral 80 mg dose of 14C-stavudine in healthy subjects.
Maltese: Stavudine mhux mibdul kien il-komponent ewlieni relatat mal-mediċina fir-radjuattività totali li kienet tiċċirkola fil-plażma wara doża orali ta' 80 mg ta' 14C-stavudine f'individwi b'saħħithom.
English: The active substance is stavudine (40 mg).
Maltese: Is-sustanza attiva hija stavudine (40 mg).
English: INFORMATION IN BRAILLE Zerit 30 mg
Maltese: Zerit 30 mg
English: The active substance is stavudine (30 mg).
Maltese: Is-sustanza attiva hija stavudine (30 mg).
English: Zerit 40 mg hard capsules
Maltese: Zerit 40 mg kapsula iebsa
English: Macrocytosis was not evaluated in these trials, but was found to be associated with Zerit in an earlier trial (MCV > 112 fl occurred in 30% of patients treated with Zerit).
Maltese: Makroċitożi ma ġietx evalwata f'dawn l-istudji, imma nstab li hi assoċjata ma' Zerit fi prova li saret aktar kmieni (MCV > 112 fl dehret fi 30% tal-pazjenti li ħadu Zerit.
English: The duration of therapy with Zerit should be limited to the shortest time possible (see section 4.2).
Maltese: It-tul tat-terapija b'Zerit għandu jkun limitat għall-inqas żmien possibbli (ara sezzjoni 4.2).
English: INFORMATION IN BRAILLE Zerit 20 mg
Maltese: Zerit 20 mg
English: These studies include ACTG 240, where 105 paediatric patients ages 3 months to 6 years received Zerit 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received Zerit 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a clinical trial where 8 newborns received Zerit 2 mg/kg/day in combination with didanosine and nelfinavir from birth through 4 weeks of age.
Maltese: Dawn listudji jinkludu ACTG 240, fejn 105 pazjenti pedjatriċi bl-età tvarja minn 3 xhur għal 6 snin ngħataw Zerit 2 mg/kg/jum għal medja ta' 6.4 xhur; studju kliniku kkontrollat fejn 185 tarbija tat-twelid ingħataw Zerit 2 mg/kg/jum waħdu jew ma' didanosine mit-twelid sakemm kellhom 6 ġimgħat; u studju kliniku fejn 8 trabi tat-twelid ingħataw Zerit 2 mg/kg/jum b'kombinazzjoni ma' didanosine u nelfinavir mit-twelid sakemm kellhom 4 ġimgħat.
English: Metabolites include oxidised stavudine, glucuronide conjugates of stavudine and its oxidised metabolite, and an N-acetylcysteine conjugate of the ribose after glycosidic cleavage, suggesting that thymine is also a metabolite of stavudine.
Maltese: Il-metaboliti jinkludu stavudine ossidat, konjugati glucuronide ta' stavudine u l-metabolit ossidat tiegħu, u konjugat N-acetylcysteine tar-ribose wara tkissir glikosidiku, u dan jissuġġerixxi li thymine hi wkoll metabolit ta' stavudine.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq BRISTOL-MYERS SQUIBB PHARMA EEIG Plaza 254
English: Mean renal clearance of the parent compound is approximately 272 ml/min, accounting for approximately 67% of the apparent oral clearance, indicating active tubular secretion in addition to glomerular filtration.
Maltese: Il-medja tat-tneħħija mill-kliewi talkompost prinċipali hi ta' madwar 272 ml/min, li jammonta għal madwar 67 % tat-tneħħija orali apparenti, li tindika tnixxija tubulari attiva flimkien ma' filtrazzjoni glomerulari.
English: The decrease of susceptibility in vitro is subtle requiring two or more TAMs (generally M41L and T215Y) before stavudine susceptibility is decreased (> 1.5 fold).
Maltese: It-tnaqqis tas-suxxettibbilità in vitro hi sottili u teħtieġ żewġ TAMs jew aktar (ġeneralment M41L u T215Y) qabel is-suxxettibbilità ta' stavudine tonqos (> 1.5 darbiet).
English: The other ingredients of the powder contained in the hard capsule are: lactose (240 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Maltese: L-ingredjenti l-oħra tat-trab li hemm fil-kapsula iebsa huma: lactose (240 mg), magnesium stearate, microcrystalline cellulose u sodium starch glycolate.
English: The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C).
Maltese: Is-soluzzjoni orali mħejjija hija stabbli għal 30 jum fi friġġ (2°C -8°C).
English: The activity of stavudine is also affected by multi-drug resistance associated mutations such as Q151M.
Maltese: L-attività ta' stavudine hi affettwata wkoll minn mutazzjonijiet assoċjati mar-reżistenza ta' diversi mediċini, bħal Q151M.
English: Preliminary safety data from this study (see also section 4.8), showed an increased infant mortality in the stavudine + didanosine (10%) treatment group compared to the stavudine (2%), didanosine (3%) or zidovudine (6%) groups, with a higher incidence of stillbirths in the stavudine + didanosine group.
Maltese: Tagħrif preliminari tas-sigurtà minn dan l-istudju (ara wkoll sezzjoni 4.8), wera rata ta' mewt tat-trabi ogħla fil-grupp tat-trattament bi stavudine+didanosine (10%) meta mqabbla mal-grupp ta' stavudine (2%), didanosine (3%) jew zidovudine (6%), b'numru ikbar ta' trabi jitwieldu mejta fil-grupp stavudine+didanosine.
English: In antiretroviral naive patients
Maltese: F'pazjenti li qatt ma ngħataw antiretrovirali
English: common: peripheral neurologic symptoms including peripheral neuropathy, paresthesia, and peripheral neuritis; dizziness; abnormal dreams; headache, insomnia; abnormal thinking; somnolence very rare: motor weakness* (most often reported in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome)
Maltese: komuni: sintomi newroloġiċi periferali li jinkludu newropatija periferali, parestesija, u newrite periferali; sturdament; ħolm anormali; uġigħ ta' ras, nuqqas ta' rqad; ħsibijiet anormali; ngħas tqil rari ħafna: dgħufija fil-moviment* (il-biċċa l-kbira rrappurtata fi sfond ta' iperlaktatemija sintomatika jew sindrome ta' aċidożi lattika).
English: Zerit 15 mg hard capsules Stavudine
Maltese: Zerit 15 mg kapsuli iebsin Stavudine
English: Elderly: Zerit has not been specifically investigated in patients over the age of 65.
Maltese: Zerit ma ġiex studjat speċifikament f'pazjenti li kellhom iżjed minn 65 sena.
English: Uncommon (may affect up to 1 in 100 people) lactic acidosis (build up of acid in your blood) in some cases involving motor weakness (weakness in your arms, legs or hands) gynaecomastia (breast enlargement in men) anorexia (loss of appetite), anxiety, emotional lability pancreatitis (inflammation of the pancreas), vomiting hepatitis (inflamation of the liver), jaundice (yellow of the skin or eyes) urticaria (itchy rash), arthralgia (joint pain) myalgia (aching muscles), asthenia (unusual tiredness or weakness)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100) aċidożi lattika (akkumulazzjoni ta' aċidu fid-demm tiegħek) li f'xi każijiet tinvolvi dgħufija fil-moviment (dgħjufija f'dirgħajk, riġlejk jew idejk) ġinekomastja (tkabbir tas-sider fl-irġiel) anoreksja (telf ta' aptit), ansjetà, nuqqas ta' stabbilità emozzjonali pankreatite (infjammazzjoni tal-frixa), rimettar epatite (infjammazzjoni tal-fwied), suffejra (sfura tal-ġilda jew tal-għajnejn) urtikarja (raxx bil-ħakk), artralġja (uġigħ fil-ġogi) majalġja (uġigħ fil-muskoli), astenja (għeja jew dgħjufija mhux tas-soltu)
English: Peripheral neuropathy: up to 20% of patients treated with Zerit will develop peripheral neuropathy, often starting after some months of treatment.
Maltese: Newropatija periferali: sa 20% tal-pazjenti kkurati b'Zerit ser jiżviluppaw newropatija periferali, li ta' spiss tibda wara xi xhur ta' kura.
English: The other ingredients of the powder contained in the hard capsule are: lactose (180 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Maltese: L-ingredjenti l-oħra tat-trab li hemm fil-kapsula iebsa huma: lactose (180 mg), magnesium stearate, microcrystalline cellulose u sodium starch glycolate.
English: Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported in < 1% of patients taking stavudine in combination with other antiretrovirals (see section 4.4).
Maltese: Każijiet ta' aċidosi lattika, xi kultant fatali, ġeneralment assoċjata ma' epatomegalija severa u steatosi epatika ġew rapportati f'< 1% tal-pazjenti li qed jieħdu stavudine flimkien ma' antiretrovirali oħra (ara sezzjoni 4.4).
English: Zerit 20 mg hard capsules Stavudine
Maltese: Zerit 20 mg kapsuli iebsin Stavudine
English: ANNEX II
Maltese: Dublin 15
English: The other ingredients of the powder contained in the hard capsule are: lactose (120 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Maltese: L-ingredjenti l-oħra tat-trab li hemm fil-kapsula iebsa huma: lactose (120 mg), magnesium stearate, microcrystalline cellulose u sodium starch glycolate.
English: Pancreatitis was reported in < 1% of patients in combination therapy studies with Zerit.
Maltese: Pankreatite kienet irrappurtata f'<1% tal-pazjenti fi studji dwar terapija b'aktar minn mediċina waħda ma' Zerit.
English: Hepatotoxicity and hepatic failure resulting in death were reported during postmarketing surveillance in HIV infected patients treated with antiretroviral agents and hydroxyurea; fatal hepatic events were reported most often in patients treated with stavudine, hydroxyurea and didanosine.
Maltese: Tossiċità u insuffiċjenza tal-fwied li tirriżulta f'mewt kienu rrappurtati matul is-sorveljanza ta' wara t-tqegħid fis-suq f'pazjenti infettati bl-HIV ikkurati b'mediċini antiretrovirali u hydroxyurea; avvenimenti fatali tal-fwied kienu rrappurtati fil-biċċa l-kbira f'pazjenti kkurati bi stavudine, hydroxyurea u didanosine.
English: Stavudine was carcinogenic in mice (liver tumours) and rats (liver tumours: cholangiocellular, hepatocellular, mixed hepatocholangiocellular, and/or vascular; and urinary bladder carcinomas) at very high exposure levels.
Maltese: Stavudine kkawża kanċer fil-ġrieden (tumur tal-fwied) u firien (tumur tal-fwied: karċinomi taċ-ċelloli tat-tubi tal-marrara (cholangocellular), taċ-ċelloli tal-fwied, tat-tnejn f'daqqa u/jew vaskulari; u karċinomi tal-bużżieqa ta' l-awrina) meta ġew esposti għal livelli għoljin ħafna.
English: 3) and a median plasma HIV-1 RNA of 4.63 log10 copies/ml (range 3.0 to 5.9 log10 copies/ml) at baseline.
Maltese: RNA ta' 4.63 log10 kopji/ml (livell ivarja bejn 3.0 sa 5.9 log10 kopji/ml) fil-linja bażi.
English: Stearate emulsifiers Sucrose
Maltese: 15 g ta' sucrose
English: The reconstituted solution contains 1 mg of stavudine per ml.
Maltese: Is-soluzzjoni rikostitwita fiha 1 mg stavudine kull ml.
English: The corresponding values after oral single and multiple dose administration are 35% (range: 8% to 72%) and 40% (range: 12% to 82%), respectively.
Maltese: Il-valuri li jikkorrispondu wara l-għoti orali ta' doża waħda u multipla huma 35 % (medda: 8 % sa 72 %) u 40 % (medda: 12 % sa 82 %), rispettivament.
English: Hepatic impairment: stavudine pharmacokinetics in patients with hepatic impairment were similar to those in patients with normal hepatic function.
Maltese: Indeboliment tal-fwied: il-farmakokinetiċi ta' stavudine f'pazjenti b'indeboliment tal-fwied kienet simili għal dik f'pazjenti b'funzjoni normali tal-fwied.
English: Patients at increased risk should be followed closely (see also section 4.6).
Maltese: Pazjenti li għandhom riskju li jkollhom din il-kundizzjoni għandhom jiġu segwiti bir-reqqa (ara wkoll sezzjoni 4.6).
English: Cmax and AUC increased proportionally with dose in the dose ranges, intravenous 0.0625-0.75 mg/kg, and oral 0.033-4.0 mg/kg.
Maltese: Wara li ngħataw ħafna dożi orali ta' 0.5-0.67 mg/kg, kien hemm livell ta' Cmax ta' 810±175 ng/ml. Cmax u AUC wrew żieda proporzjonali mad-doża fil-livelli tad-doża mill-vini 0.0625-0.75 mg/kg u mill-ħalq 0.033-4.0 mg/kg.
English: Rare (may affect up to 1 in 1,000 people) anemia hyperglycaemia (high sugar levels in the blood) hepatic steatosis (fat in the liver)
Maltese: Rari (jistgħu jaffetwaw sa persuna 1 minn kull 1,000) anemija, ipergliċemija (livelli għoljin ta' zokkor fid-demm) steatożi tal-fwied (xaħam fil-fwied)
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni tal-HIV avvanzata (AIDS) u bi storja ta' infezzjoni opportunistika, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet preċdenti, jistgħu jseħħu wara li tinbeda kura kontra l-HIV.
English: Stavudine
Maltese: Treddigħ
English: a Number of patients evaluable.
Maltese: a Numru ta' pazjenti li jistgħu jiġu evalwati.
English: No clinically relevant pharmacokinetic interaction has, however, been seen with lamivudine.
Maltese: Madanakollu ma dehret l-ebda interazzjoni farmakokinetika klinikament relevanti ma' lamivudine.
English: For patients starting therapy with Zerit, the duration should be limited to the shortest time possible followed by a switch to an alternative appropriate therapy whenever possible.
Maltese: Għal pazjenti li jibdew terapija b'Zerit, dan għandu jkun limitat għall-inqas żmien possibbli u jinbidel għal terapija alternattiva xierqa kull meta jkun possibbli.
English: Immune reactivation syndrome: 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: Sindromu ta' reattivitazzjoni immunitarja: f'pazjenti infettati bl-HIV b'nuqqas gravi ta' immunità fiżżmien ta' meta tinbeda terapija ta' kombinazzjoni antiretrovirali (CART), jsita' jkun hemm reazzjoni ta' infjammazzjoni fl-infezzjonijiet li ma jkunu wrew l-ebda sintomu jew li jkun għad baqa'.
English: Stavudine's influence on the phosphorylation kinetics of nucleoside analogues other than zidovudine has not been investigated.
Maltese: Għadha ma ġietx investigata l-influwenza ta' stavudine fuq ilkinetiċi tal-fosforiliżżazzjoni ta' analogi oħra tan-nuklejosidi barra minn zidovudine.
English: HIV RNA Mean Change from Baseline, log10 copies/ml All patients
Maltese: HIV RNA Bidla Medja mil-Linja Bażi, log10 kopji/ml Il-pazjenti kollha
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/009/001 - 008
English: The pharmacokinetics of stavudine was independent of time, since the ratio between AUC(ss) at steady state and the AUC(0-t) after the first dose was approximately 1.
Maltese: Il-farmakokinetika ta' stavudine kienet indipendenti mill-ħin, minħabba li l-proporzjon ta' AUC(ss) fi stat stabbli mqabbel ma' l-AUC(0-t) wara l-ewwel doża kien bejn wieħed u ieħor ta' 1.
English: (range 63 to 962 cells/mm3) and a median plasma HIV-1 RNA of 4.63 log10 copies/ml (range 3.0 to 5.9 log10 copies/ml) at baseline.
Maltese: (600 mg darba kuljum), f'76 pazjenti li qatt ma kienu ħadu trattament qabel, b'għadd medju ta' ċelloli CD4 ta' 261 ċelloli/mm3 (ammont ivarja bejn 63 u 962 ċelloli/mm3) u livell medju ta' plażma HIV-1 RNA ta' 4.63 log kopji/ml (livell ivarja bejn 3.0 sa 5.9 log10 kopji/ml) fil-linja bażi.
English: Stable for 30 days after reconstitution, when stored in a refrigerator.
Maltese: Stabbli għal 30 ġurnata wara rikostituzzjoni, meta maħżun fi friġġ.
English: common: depression uncommon: anxiety, emotional lability
Maltese: komuni: dipressjoni mhux komuni: ansjetà, nuqqas ta' stabbiltà emozzjonali
English: Study AI455-096 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 76 treatment-naive patients, with a median CD4 cell count of 261 cells/mm3
Maltese: Studju AI455-096 kien studju ta' 48 ġimgħa, b'kampjun magħżul kif jinzerta, double blind fejn Zerit (40 mg darbtejn kuljum) flimkien ma' lamivudine (150 mg darbtejn kuljum) kif ukoll efavirenz (600 mg darba kuljum), f'76 pazjenti li qatt ma kienu ħadu trattament qabel, b'għadd medju ta' ċelloli CD4 ta' 261 ċellolia/mm
English: Zerit 20 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Maltese: Zerit 20 mg kapsuli iebsin jiġu f'pakketti tal-folji b'56 kapsula iebsin jew fliexken b'60 kapsuli iebsin.
English: Off-white to pale-pink, gritty powder.
Maltese: Trab ramli, offwajt għal roża mitfi.
English: The evolution of motor weakness may mimic the clinical presentation of Guillain-Barré syndrome (including respiratory failure).
Maltese: L-evoluzzjoni ta' dgħjufija tal-muskoli tista' fil-bidu tkun tixbah klinikament is-sindrome ta' Guillain-Barré (li tinkludi insuffiċjenza respiratorja).
English: The HIV status for the newborns and infants ≤ 3 months of age was negative, for older infants it tended to be positive.
Maltese: L-istat ta' l-HIV fit-trabi tat-twelid u trabi ≤ 3 xhur fl-età kien wieħed negattiv, għat-trabi akbar minn hekk l-istat kellu tendenza jkun pożittiv.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues (see also section 4.8); these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Kien hemm rapporti ta' disfunzjoni tal-mitonkondrija fi trabi li huma negattivi għall-HIV li kienu esposti in utero u/jew wara t-twelid għall-analogi tan-nuklejosidi (ara wkoll sezzjoni 4.8); dawn kellhom x'jaqsmu b'mod predominanti mal-kura b'reġimens li kien fihom zidovudine.
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: +370 52 369140
Maltese: BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. Tel.: + 48 22 5796666
English: INFORMATION IN BRAILLE Zerit 40 mg
Maltese: Zerit 40 mg
English: Zerit 30 mg hard capsules Stavudine
Maltese: Zerit 30 mg kapsuli iebsin Stavudine
English: Zerit 15 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Maltese: Zerit 15 mg kapsuli iebsin jiġu f'pakketti tal-folji b'56 kapsula iebsin jew fliexken b'60 kapsuli iebsin.
English: Adverse reactions of moderate or greater severity with at least a possible relationship to treatment regimen (based on investigator attribution) reported from 467 patients treated with Zerit in combination with lamivudine and efavirenz in two randomised clinical trials and along-term follow-up study (follow-up: median 56 weeks ranging up to 119 weeks) are listed below.
Maltese: Reazzjonijiet avversi ta' severità moderata jew aktar b'mill-inqas relazzjoni possibbli għal kors ta' kura (ibbażat fuq attribuzzjoni tal-investigatur), irrappurtati minn 467 pazjent ikkurati b'Zerit flimkien ma' lamivudine u efavirenz f'żewġ provi kliniċi li fihom il-parteċipanti ntgħażlu b'mod każwali, u studju tat-tip fuq perijodu twil ta' follow-up (follow-up: medjan 56 ta' ġimgħa li varja sa 119il ġimgħa) huma elenkati hawn taħt.
English: Do not store above 30°C (HDPE bottles).
Maltese: Taħżinx f'temperatura ‘l fuq minn 30°C (fliexken HDPE).
English: Osteonecrosis: 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 combination antiretroviral therapy (CART).
Maltese: Osteonecrosis: għalkemm l-etjoloġija hi kkunsidrata li għandha ħafna fatturi (inklużi l-użu ta' sterojdi tal-kortiċi, konsum ta' alkoħol, trażżin gravi ta' l-immunità, indiċi ta' massa tal-ġisem ogħla), każi ta' osteonecrosis kienu rrapurtati b'mod partikulari f'pazjenti bil-marda ta' l-HIV avvanzata u/jew b'espożizzjoni fuq medda twila għat-terapija ta' kombinazzjoni antiretrovirali (CART).
English: Cellular DNA polymerase γ is also sensitive to inhibition by stavudine triphosphate, while cellular polymerases α and β are inhibited at concentrations 4,000-fold and 40-fold higher, respectively, than that needed to inhibit HIV reverse transcriptase.
Maltese: Il-polymerase γ tad-DNA fiċ-ċelloli jnaqqas l-attività tiegħu b'stavudine triphospate, waqt li l-attivitΰ tal-polymerase α u β ta' ġoċ-ċelloli titnaqqas b'konċentrazzjonijiet 4,000 u 40 darba ogħla rispettivament minn dik li hi meħtieġa biex titnaqqas l-attività tar-reverse transcriptase ta' l-HIV.
English: However lactic acidosis, sometimes fatal, has been reported in pregnant women who received the combination of didanosine and stavudine with or without other anti-retroviral treatment (see sections 4.3 and 4.4).
Maltese: Madanakollu, l-aċidożi lattika li xi drabi twassal għall-mewt, ġiet irrappurtata f'nisa tqal li ngħataw ilkombinazzjoni ta' didanosine u stavudine ma' jew mingħajr trattament antiretrovirali ieħor (ara sezzjonijiet 4.3 u 4.4).
English: Zerit belongs to a particular group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: Zerit jagħmel parti minn grupp partikolari ta' mediċini antivirali, magħrufa wkoll bħala antiretrovirali, msemmijin nukleosidi inibituri tat-traskrittażi nversi (NRTIs).
English: Zerit 40 mg hard capsules Stavudine
Maltese: Zerit 40 mg kapsuli iebsin Stavudine
English: Do not store the dry powder above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/009/007
English: Zerit 40 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Maltese: Zerit 40 mg kapsuli iebsin jiġu f'pakketti tal-folji b'56 kapsula iebsin jew fliexken b'60 kapsuli iebsin.
English: zidovudine, used to treat HIV infection doxorubicin, used to treat cancer ribavirin, used to treat hepatitis C infection
Maltese: Jekk qed tieħu didanosine, użat biex jikkura infezzjoni tal-HIV.
English: Patients were primarily males (70%) and non-white (58%) with a median age of 33 years (range 18 to 68 years).
Maltese: Pazjenti kienu l-aktar rġiel (70%) u mhux bojod (58%) b'età medja ta' 33 sena (età tvarja bejn 18 sa 68 sena).
English: Laboratory abnormalities: laboratory abnormalities reported in these two trials and an ongoing follow-up study included elevations of ALT (> 5 x ULN) in 3%, of AST (> 5 x ULN) in 3%, of lipase (≥ 2.1 ULN) in 3% of the patients in the Zerit group.
Maltese: Anormalitajiet tal-laboratorju: riżultati anormali tat-testijiet fil-laboratorju ġew rrappurtati f'dawn iżżewġ studji u fi studju fit-tul li għadu għaddej u dan jinkludi livell ogħla ta' ALT (> 5 x l-ogħla livell normali) fi 3%, ta' AST (> 5 x l-ogħla livell normali) fi 3%, ta' lipase (≥ 2.1 x l-ogħla livell normali).