FrancophonIA/ELRC3.0 huggingface dataset:
English: Zerit 15 mg hard capsules Zerit 20 mg hard capsules Zerit 30 mg hard capsules Zerit 40 mg hard capsules
Maltese: Zerit 15 mg kapsula iebsa Zerit 20 mg kapsula iebsa Zerit 30 mg kapsula iebsa Zerit 40 mg kapsula iebsa
English: V75T is selected in vitro by stavudine and reduces susceptibility to stavudine by 2-fold.
Maltese: V75T tintgħażel in vitro minn stavudine u tnaqqas id-doppju ssuxxettibbilità għal stavudine.
English: Neutropenia (< 750 cells/mm3) was reported in 5%, thrombocytopenia (platelets < 50,000/mm3) in 2%, and low haemoglobin (< 8 g/dl) in < 1% of patients receiving Zerit.
Maltese: Newtropenja (< 750 ċelloli/mm3) ġie rrappurtat f' 5%, tromboċitopenja (plejtlets] < 50,000/mm3) fi 2% u emoglobina baxxa (< 8 g/dl) f'1% tal-pazjenti fuq Zerit.
English: HIV RNA < 400 copies/ml, treatment response, % All patients
Maltese: HIV RNA < 400 kopja/ml, rispons għall-kura, % Il-pazjenti kollha
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: Il-frekwenza ta' reazzjonijiet avversi elenkata hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: HIV RNA < 50 copies/ml, treatment response, % All patients
Maltese: HIV RNA < 50 kopja/ml, rispons għall-kura, % Il-pazjenti kollha
English: Zerit has been studied in combination with other antiretroviral agents, e.g. didanosine, lamivudine, ritonavir, indinavir, saquinavir, efavirenz, and nelfinavir.
Maltese: Zerit ġie studjat b'kombinazzjoni ma' mediċini antiretrovirali oħra p.e. didanosine, lamivudine, ritonavir, indinavir, saquinavir, efavirenz u nelfinavir.
English: 1 mg/kg twice daily (every 12 hours) adult dosing
Maltese: 1 mg/kg darbtejn kuljum (kull 12il siegħa) Doża ta' l-adulti
English: This should be taken into account in patients with diabetes mellitus.
Maltese: Dan għandu jitqies f'pazjenti b'diabetes mellitus.
English: In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅h/ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ml (27%), and Cmin was 9±8 ng/ml (89%).
Maltese: Fi tmien pazjenti li ħadu 40 mg darbtejn kuljum waqt li kienu sajma, l-AUC0-12h fi stat stabbli kien 1284±227 ng⋅h/ml (18 %) (medja ± SD [% CV]), Cmax kien 536±146 ng/ml (27 %), u Cmin kien 9±8 ng/ml (89 %).
English: common: fatigue uncommon: asthenia
Maltese: komuni: għeja mhux komuni: telqa gravi (asthenia)
English: PHARMACEUTICAL FORM AND CONTENTS Powder for oral solution, 200 mg
Maltese: U KONTENUT Trab għal soluzzjoni orali, 200 mg
English: 15 mg twice daily 15 mg every 24 hours
Maltese: 15 mg darbtejn kuljum 15 mg kull 24 siegħa
English: Do not take Zerit
Maltese: Tiħux Zerit
English: Each hard capsule contains 79.53 mg of lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 79.53 mg ta' lactose monohydrate.
English: 20 mg twice daily 20 mg every 24 hours
Maltese: 20 mg darbtejn kuljum 20 mg kull 24 siegħa
English: The capsule shells are marked using edible black printing ink containing shellac, propylene glycol, purified water, potassium hydroxide and iron oxide (E172).
Maltese: Il-qxur tal-kapsuli huma mmarkati permezz ta' linka sewda li tista' tittiekel li fiha shellac, propylene glycol, ilma ppurifikat, potassium hydroxide u iron oxide (E172).
English: Zerit 200 mg powder for oral solution Stavudine
Maltese: Zerit 200 mg trab għal soluzzjoni orali Stavudine
English: Each hard capsule contains 159.06 mg of lactose anhydrous.
Maltese: Kull kapsula iebsa fiha 159.06 mg ta' lactose anhydrous.
English: Excipients: the reconstituted powder for oral solution contains 50 mg sucrose per ml of reconstituted solution.
Maltese: Eċċipjenti: it-trab għal soluzzjoni orali fih 50 mg sucrose kull ml tas-soluzzjoni rikostitwita.
English: Apparent oral clearance was approximately 14 ml/min/kg for infants ages 5 weeks to 15 years, 12 ml/min/kg for infants ages 14 to 28 days, and 5 ml/min/kg for infants on the day of birth.
Maltese: Il-clearance orali apparenti kienet ta' bejn wieħed u ieħor 14 ml/min/kg għal tfal ta' daqs bejn 5 ġimgħat u 15-il sena, 12 ml/min/kg għal trabi ta' bejn 14 u 28 ġurnata, u 5 ml/min/kg għal trabi fil-ġurnata li twieldu.
English: Adolescents, children and infants over the age of 3 months: the recommended oral dosage is Patient weight Zerit dosage < 30 kg ≥ 30 kg
Maltese: Adoloxxenti, tfal u trabi ‘l fuq minn 3 xhur: id-doża orali rrakkomandata hija Piż tal-pazjent Doża ta' Zerit < 30 kg ≥ 30 kg
English: Each hard capsule contains 60.66 mg of lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 60.66 mg ta' lactose monohydrate.
English: Intra-and interindividual variation in pharmacokinetic characteristics of stavudine is low, approximately 15% and 25%, respectively, after oral administration.
Maltese: Il-varjazzjoni flistess individwu u bejn l-individwi tal-karatteristiċi farmakokinetiċi ta' stavudine kienet baxxa, bejn wieħed u ieħor 15% u 25%, rispettivament, wara amministrazzjoni orali.
English: Aclar/aluminum blisters with 14 hard capsules per card and 4 cards (56 hard capsules) per carton.
Maltese: Folji aclar/aluminju b'14-il kapsula iebsa f'kull kartuna u erba' kartun (56 kapsuli ibsin) f'kull pakkett.
English: In HIV-infected patients, total clearance of stavudine is 594±164 ml/min, and renal clearance is 237±98 ml/min.
Maltese: F'pazjenti infettati bl-HIV, it-tneħħija totali ta' stavudine hi ta' 594±164 ml/min, u t-tneħħija mill-kliewi hi ta' 237±98 ml/min.
English: The mean haemodialysis clearance of stavudine is 120 ml/min.
Maltese: Il-clearance medju ta' stavudine bl-emodijaliżi huwa ta' 120 ml/min.
English: In study AI455-094, performed in South-Africa, 362 mother-infant pairs were included in a prevention of mother-to-child-transmission study.
Maltese: Fl-istudju AI455-094, li sar fl-Afrika t'Isfel, 362 par ta' ommijiet u wliedhom kienu inklużi fi studju ta' prevenzjoni ta' trasmissjoni mill-omm għat-tarbija.
English: The clinical relevance of these findings suggest that stavudine should be generally avoided in the presence of TAMs, especially M41L and T215Y.
Maltese: Ir-rilevanza klinika ta' dawn ir-riżultati tissuġġerixxi li stavudine ġeneralment għandu jiġi evitat filpreżenza ta' TAMs, speċjalment M41L u T215Y.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Maltese: Eżempji relevanti huma cytomegalovirus retinitis, infezzjonijiet mikobatteritiċi ġeneralizzati u/jew fokali, u pnewmonja Pneumocystis carinii.
English: 30 mg twice daily (every 12 hours) 40 mg twice daily (every 12 hours)
Maltese: 30 mg darbtejn kuljum (kull 12-il siegħa) 40 mg darbtejn kuljum (kull 12-il siegħa)
English: Each bottle contains 31.5 mg of propylhydroxybenzoate (E216) Each bottle contains 315 mg of methylhydroxybenzoate (E218) Each bottle contains 10.15 g of sucrose
Maltese: Kull flixkun fih 31.5 mg ta' propylhydroxybenzoate (E216) Kull flixkun fih 315 mg ta' methylhydroxybenzoate (E218)
English: Each hard capsule contains 121.09 mg of lactose anhydrous.
Maltese: Kull kapsula iebsa fiha 121.09 mg ta' lactose anhydrous.
English: Each hard capsule contains 121.30 mg of lactose anhydrous.
Maltese: Kull kapsula iebsa fiha 121.30 mg ta' lactose anhydrous.
English: common: rash, pruritus uncommon: urticaria
Maltese: komuni: raxx, ħakk mhux komuni: urtikarja
English: Following an oral 80-mg dose of 14C-stavudine to healthy subjects, approximately 95% and 3% of the total radioactivity was recovered in urine and faeces, respectively.
Maltese: Wara doża orali ta' 80 mg ta' 14C-stavudine lil persuni b'saħħithom, madwar 95 % u 3 % tar radjuattività totali kienet irkuprata fl-awrina u fl-ippurgar, rispettivament.
English: Four hours after administration, the CSF/plasma ratio was 0.39±0.06.
Maltese: Erba' sigħat wara li ngħata, il-livell CSF/plażma kien ta' 0.39±0.06.
English: 0.5 mg/kg twice daily (every 12 hours)
Maltese: 0.5mg/kg darbtejn kuljum (kull 12-il siegħa)
English: * Adverse reactions observed post-marketing in association with stavudine-containing antiretroviral treatment ** See Section Description of selected adverse reactions for more details.
Maltese: * Reazzjonijiet avversi osservati wara t-tqegħid fis-suq assoċjati ma' kura antiretrovirali li fiha stavudine ** Ara Sezzjoni Deskrizzjoni ta' reazzjonijiet avversi magħżula għal aktar dettalji.
English: Adults: the recommended oral dosage is
Maltese: Adulti: id-doża orali rrakkomandata hija
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew nuqqas ta'assorbiment ta' glucose-galactose, ma għandhomx jieħdu din il-mediċina.
English: Zerit 40 mg hard capsules are dark orange and marked with “BMS 1967” on one side and “40” on the other side.
Maltese: Zerit 40 mg kapsuli iebsin ta' kulur oranġjo skur u mmarkati b' “BMS 1967” fuq naħa waħda u “40” fuq in-naħa l-oħra.
English: The mean terminal elimination half-life of stavudine is 1.3 to 2.3 hours following single or multiple doses, and is independent of dose.
Maltese: Il-medja tal-eliminazzjoni terminali tal-half-life ta' stavudine hi ta' 1.3 sa 2.3 sigħat wara dożi waħidhom jew multipli, u hi indipendenti mid-doża.
English: Zerit 20 mg hard capsules are brown and marked with “BMS 1965” on one side and “20” on the other side.
Maltese: Zerit 20 mg kapsuli iebsin ta' kulur kannella u mmarkati b' “BMS 1965” fuq naħa waħda u “20” fuq in-naħa l-oħra.
English: Not recommended combinations: pancreatitis (fatal and nonfatal) and peripheral neuropathy (severe in some cases) have been reported in HIV infected patients receiving stavudine in association with hydroxyurea and didanosine (see section 4.3).
Maltese: Taħlit mhux irrakkomandat: pankreatite (fatali u mhux fatali) u newropatija periferali (severa f'xi każijiet) kienu rrappurtati f'pazjenti infettati bl-HIV li kienu qed jingħataw stavudine flimkien ma' hydroxyurea u didanosine (ara sezzjoni 4.3).
English: Mitochondrial dysfunction following exposure in utero: nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: Disfunzjoni tal-mitokondrija wara esponiment in utero: analogi nukleos(t)ide jista' jkollhom impatt fuq il-funzjoni mitokondrijali sa grad varjabbli, li jkun jinħass l-iktar bi stavudine, didanosine u zidovudine.
English: Each hard capsule contains 60.54 mg of lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 60.54 mg ta' lactose monohydrate.
English: No evidence of impaired fertility was seen in rats at high exposure levels (up to 216 times that observed at the recommended clinical dose).
Maltese: Ma kienet osservata l-ebda evidenza ta' nuqqas fil-fertilità tal-firien f'livelli għolja ta' espożizzjoni (sa 216-il darba ta' dak osservat fid-doża klinika rrakkomandata).
English: After reconstitution with water, the solution contains 50 mg of sucrose per ml of solution.
Maltese: Wara rikostituzzjoni bl-ilma, is-soluzzjoni ikun fiha 50 mg ta' sucrose kull ml ta' soluzzjoni.
English: Patients were primarily males (76%) and white (66%) with a median age of 34 years (range 22 to 67 years).
Maltese: Pazjenti kienu laktar rġiel (76%) u bojod (66%) b'età medja ta' 34 sena (età tvarja bejn 22 u 67 sena).
English: Each hard capsule contains 80.84 mg of lactose anhydrous.
Maltese: 84 mg ta' lactose anhydrous.
English: Zerit should be reconstituted with water to a 200 ml deliverable volume solution (stavudine concentration of 1 mg/ml).
Maltese: Zerit għandu jiġi rikostitwit bl-ilma sakemm ikun hemm volum ta' likwidu ta' 200 ml (konċentrazzjoni ta' stavudine ta' 1 mg/ml).
English: Pancreatitis, occasionally fatal, has been reported in up to 2-3% of patients enrolled in monotherapy clinical studies (see section 4.4).
Maltese: Pankreatite, xi kultant fatali, kienet irrappurtata fi2 sa 3% tal-pazjenti rreġistrati fi studji kliniċi b'mediċina waħda (ara sezzjoni 4.4).
English: Zidovudine and stavudine are phosphorylated by the cellular enzyme (thymidine kinase), which preferentially phosphorylates zidovudine, thereby decreasing the phosphorylation of stavudine to its active triphosphate form.
Maltese: Zidovudine u stavudine jiġu fosforilizzati bl-enżima ċellulari (thymidine kinase) li preferenzjalment jiffosforiliżża zidovudine, għalhekk inaqqas il-fosforilazzjoni ta' stavudine għall-forma attiva tiegħu triphosphate.
English: common: lipoatrophy**, asymptomatic hyperlactatemia uncommon: lactic acidosis (in some cases involving motor weakness), anorexia rare: hyperglycaemia* very rare: diabetes mellitis*
Maltese: komuni: lipoatrofija**, iperlaktatemija asintomatika mhux komuni: aċidożi lattika (f'xi każijiet tinvolvi dgħufija fil moviment), anoreksja rari: ipergliċemija* rari ħafna: dijabete mellitus*
English: The active substance is stavudine (200 mg).
Maltese: Is-sustanza attiva hija stavudine (200 mg).
English: Zerit 15 mg hard capsules
Maltese: Zerit 15 mg kapsula iebsa
English: Study AI455-099 was a 48-week, randomised, double-blind study withZerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 391 treatment-naive patients, with a median CD4 cell count of 272 cells/mm (range 61 to 1,215 cells/mm3) and a median plasma HIV-1 RNA of 4.80 log10 copies/ml (range 2.6 to 5.9 log 10 copies/ml) at baseline.
Maltese: Studju AI455-099 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), fi 391 pazjent li qatt ma kienu ħadu trattament qabel, b'għadd medju ta' ċelloli CD4 ta' 272 ċellolia/mm3 (ammont ivarja bejn 61 u 1,215 ċelloli/mm3) u livell medju ta' plażma HIV1 RNA ta' 4.80 log10 kopji/ml (livell ivarja bejn 2.6 sa 5.9 log10 kopji/ml) fil-linja bażi.
English: The combination of stavudine with didanosine is contraindicated given that both drugs exhibits high risk of mitochondrial toxicity (see sections 4.3 and 4.4).
Maltese: Il-kombinazzjoni ta' stavudine ma' didanosine hija kontrainidikata minħabba li ż-żewġ mediċini juru riskju għoli ta' tossiċità mitokondrijali (ara sezzjonijiet 4.3 u 4.4).
English: The mechanism and clinical significance of this difference are unknown.
Maltese: Il-mekkaniżmu u r-rilevanza klinika ta' din id-differenza mhumiex magħrufa.
English: INFORMATION IN BRAILLE Zerit 15 mg
Maltese: Zerit 15 mg
English: These TAMs are seen at a similar frequency with stavudine and zidovudine in virological treatment.
Maltese: Dawn it-TAMs jiġu osservati fi frekwenza simili bi stavudine u zidovudine f'kura viroloġika.
English: In vitro, stavudine triphosphate has an intracellular half-life of 3.5 hours in CEM T-cells (a human T-lymphoblastoid cell line) and peripheral blood mononuclear cells, supporting twice daily dosing.
Maltese: In vitro, stavudine triphosphate għandu half-life intraċellulari ta' 3.5 sigħat fiċ-ċelluli T CEM (razza ta' ċelluli limfoblastojdi T tal-bniedem) u ċelluli mononukleari tad-demm periferali, li jsostni dożaġġ ta' darbtejn kuljum.
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 li qegħdin fuq terapija antiretrovirali kombinata għandhom riskju akbar ta' reazzjonijiet avversi tal-fwied li jistgħu jkunu fatali.
English: Zerit 15 mg hard capsules Each hard capsule contains 15 mg of stavudine.
Maltese: Zerit 15 mg kapsula iebsa Kull kapsula iebsa fiha 15 mg ta' stavudine.
English: Zerit 20 mg hard capsules Each hard capsule contains 20 mg of stavudine.
Maltese: Zerit 20 mg kapsula iebsa Kull kapsula iebsa fiha 20 mg ta' stavudine.
English: Zerit 30 mg hard capsules are light and dark orange and marked with “BMS 1966” on one side and “30” on the other side.
Maltese: Zerit 30 mg kapsuli iebsin ta' kulur oranġjo ċar u skur u mmarkati b' “BMS 1966” fuq naħa waħda u “30” fuq in-naħa l-oħra.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: Irreazzjonijiet avversi l-aktar komuni li kienu rrapurtati jinkludu mard ematoloġiku (anemija, newrotropenja) u mard metaboliku (iperlaktimja, iperlipejżemja).
English: There was, however, 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: Kien hemm rata ogħla ta' mewt tat-trabi fil-grupp stavudine+didanosine (10%) meta mqabbla mal-gruppi ta' stavudine (2%), didanosine (3%), jew zidovudine (6%), b'ammont ogħla ta' trabi jitwieldu mejta fil-grupp stavudine+didanosine.
English: After intravenous administration, 42% (range: 13% to 87%) of dose is excreted unchanged in the urine.
Maltese: Wara l-għoti ġol-vini, 42 % (medda: 13 % sa 87 %) tad-doża titneħħa mhux mibdula fl-awrina.
English: Zerit dosage
Maltese: Zerit fih il-lactose
English: Metabolic parameters: weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Maltese: Parametri metaboliċi: il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
English: The active substance is stavudine (20 mg).
Maltese: Is-sustanza attiva hija stavudine (20 mg).
English: After reconstitution, store the prepared oral solution in a refrigerator (2°C - 8°C) for 30 days.
Maltese: Wara rikostituzzjoni, aħżen is-soluzzjoni orali ppreparata fil-friġġ għal 30 ġurnata (2°C-8°C).
English: Zerit contains sucrose and preservatives
Maltese: Zerit fih sucrose u preżervattivi
English: 1 mg/kg twice daily (every 12 hours)
Maltese: 1 mg/kg darbtejn kuljum (kull 12-il siegħa)
English: rare: anaemia* very rare: neutropenia*, thrombocytopenia*
Maltese: Disturbi fid-demm u fis-sistema limfatika rari: anemija* rari ħafna: newtropenija*, tromboċitopenija*
English: Lipoatrophy was commonly reported in patients treated with stavudine in combination with other antiretrovirals (see section 4.4).
Maltese: Il-lipoatrofija ġiet rapportata b'mod komuni f'pazjenti trattati b'stavudine flimkien ma' antiretrovirali oħra (ara sezzjoni 4.4).
English: How to take Zerit
Maltese: Doża ta' Zerit
English: Peripheral neuropathy was seen in combination studies of Zerit with lamivudine plus efavirenz; the frequency of peripheral neurologic symptoms was 19% (6% for moderate to severe) with a rate of discontinuation due to neuropathy of 2%.
Maltese: In-newropatija periferali ntweriet fi studji flimkien ta' Zerit ma' lamivudine flimkien ma' efavirenz, bil-frekwenza ta' sintomi newroloġiċi periferali ikun ta' 19% (6% bejn moderati sa severi) b'rata ta' waqfien minħabba newropatija ta' 2 %.
English: Stavudine, a thymidine analogue, is phosphorylated by cellular kinases to stavudine triphosphate which inhibits HIV reverse transcriptase by competing with the natural substrate, thymidine triphosphate.
Maltese: Stavudine, li huwa analogu ta' thymidine, ċellolijiġi fosforilizzat b'enzimi kinasi fiċ-ċelluli għal stavudine triphosphate li jwaqqaf ir-reverse transcriptase ta' HIV billi jikkompeti mal-molekula li jaħdem fuqha s-soltu, thymidine triphospate.
English: (range 61 to 1,215 cells/mm3) and a median plasma HIV-1 RNA of 4.80 log10 copies/ml (range 2.6 to 5.9 log 10 copies/ml) at baseline.
Maltese: CD4 ta' 272 ċellolia/mm3 (ammont ivarja bejn 61 u 1,215 ċelloli/mm3) u livell medju ta' plażma HIV1 RNA ta' 4.80 log10 kopji/ml (livell ivarja bejn 2.6 sa 5.9 log10 kopji/ml) fil-linja bażi.
English: There have been no formal interaction studies with other medicinal products.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: The active substance is stavudine (15 mg).
Maltese: Is-sustanza attiva hija stavudine (15 mg).
English: The powder formulation of ZERIT should be used for infants under the age of 3 months.
Maltese: Il-formulazzjoni ta' trab ta' Zerit għandu jintuża fi trabi taħt l-età ta' 3 xhur.
English: Stavudine therapy is associated with several severe side effects, such as lactic acidosis, lipoatrophy and polyneuropathy, for which a potential underlying mechanism is mitochondrial toxicity.
Maltese: It-terapija bi stavudine hi assoċjata ma' diversi effetti sekondarji severi, bħal aċidożi lattika, lipoatrofija u polinewropatija, li għalihom mekkaniżmu potenzjali diġà eżistenti huwa tossiċità mitokondrijali.
English: uncommon: gynaecomastia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Zerit 20 mg hard capsules
Maltese: Zerit 20 mg kapsula iebsa
English: Common (may affect up to 1 in 10 people) asymptomatic hyperlactatemia (build up of acid in your blood) lipoatrophy depression peripheral neurologic symptoms including peripheral neuropathy, paresthesia, and peripheral neuritis (numbness, weakness, tingling or pain in the arms and legs) dizziness, abnormal dreams, headache insomnia (difficulty sleeping), somnolence (sleepiness), abnormal thinking diarrhoea, abdominal pain (stomach pain of discomfort) nausea, dyspepsia (indigestion) rash, pruritus (itching) fatigue (extreme tiredness)
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) iperlaktatemija asimptomatika (akkumulazzjoni ta' aċidu fid-demm tiegħek) sindrome ta' lipoatrofija dipressjoni sintomi newroloġiċi periferali li jinkludu newropatija periferali, parestesija, u nevrite periferali (tmewwit, dgħjufija, tnemnim jew uġigħ fid-dirgħajn u fir-riġlejn) sturdament, ħolm anormali, uġigħ ta' ras nuqqas ta' rqad (diffikultà biex torqod), bi ngħas ħafna (rqad), ħsibijiet anormali dijarea, uġigħ ta' żaqq (uġigħ ta' skonfort fl-istonku) nawsja, dispepsja (indiġestjoni) raxx, pruritus (ħakk) għeja kbira (għeja estrema)
English: Adolescents, children and infants: total exposure to stavudine was comparable between adolescents, children and infants ≥ 14 days receiving the 2 mg/kg/day dose and adults receiving 1 mg/kg/day.
Maltese: Adolexxenti, tfal u trabi: l-espożizzjoni totali għal stavudine kienet komparabbli bejn adolexxenti tfal u trabi ≥ 14-il ġurnata wara li ħadu d-doża ta' 2mg/kg/jum u adulti li ħadu 1 mg/kg/jum.
English: Zerit 15 mg hard capsules are red and yellow and marked with “BMS 1964” on one side and “15” on the other side.
Maltese: Zerit 15 mg kapsuli iebsin ta' kulur aħmar u isfar u mmarkati b' “BMS 1964” fuq naħa waħda u “15” fuq in-naħa l-oħra.
English: Because stavudine is not protein-bound, it is not expected to affect the pharmacokinetics of protein-bound medicines.
Maltese: Minħabba li stavudine ma jorbotx mal-proteini, mhux mistenni li jaffetwa l-farmakokinetika talmediċini li jorbtu mal-proteini.
English: In vitro studies indicate that the activation of stavudine is inhibited by doxorubicin and ribavirin but not by other medicinal products used in HIV infection which are similarly phosphorylated, (e.g. didanosine, zalcitabine, ganciclovir and foscarnet) therefore, coadministration of stavudine with either doxorubicin or ribavirin should be undertaken with caution.
Maltese: Studji in vitro jindikaw li l-attivazzjoni ta' stavudine titwaqqaf minn doxorubicin u ribavirin iżda mhux b'mediċini oħrajn li jintużaw fl-infezzjoni bl-HIV li jiġu fosforiliżżati b'mod simili (p.e. didanosine, zalcitabine, ganciclovir u foscarnet) u għalhekk, it-tħalit ta' stavudine ma' jew doxorubicin jew ribavirin għandu jsir b'attenzjoni.
English: Zerit 40 mg hard capsules Each hard capsule contains 40 mg of stavudine.
Maltese: Zerit 40 mg kapsula iebsa Kull kapsula iebsa fiha 40 mg ta' stavudine.