FrancophonIA/ELRC3.0 huggingface dataset:
English: Sanders et al 1998 presented data on efficacy and safety of amifampridine treatment at doses up to 100 mg/day in 45 patients with LEMS who were treated for an average of 31 months.
Maltese: Sanders et al 1998 ippreżentaw dejta dwar l-effikaċja u s-sigurtà ta' kura b'amifampridine a'dożi sa100 mg/ġurnata f'45 pazjent b'LEMS li ġew trattati għal medja ta' 31 xahar.
English: • Reduced sense of touch or sensation
Maltese: • Nuqqas fis-sens tal-mess jew sensazzjoni
English: Medicinal products eliminated through metabolism or active secretion There are no data on the effects of amifampridine on the metabolism or active secretion of other medicinal products.
Maltese: M'hemmx dejta dwar l-effetti ta' amifampridine fuq il-metaboliżmu jew is-sekrezzjoni attiva ta' prodotti mediċinali oħra.
English: No subjects developed new clinically relevant ECG morphological changes following administration of amifampridine phosphate.
Maltese: L-ebda individwu ma żviluppa tibdil morfoloġiku ġdid klinikament rilevanti fl-ECG wara l-għoti ta' amifampridine phosphate.
English: • A history of fits (convulsions)
Maltese: • Storja ta' aċċessjonijiet (konvulżjonijiet)
English: • Heart rhythm disorders, fast or irregular heartbeats (palpitations)
Maltese: • Disturbi fir-ritmu tal-qalb, taħbitiet tal-qalb mgħaġġlin jew irregolari (palpitazzjonijiet)
English: Some medicines may interact with FIRDAPSE when taken together.
Maltese: Xi mediċini jistgħu jagħmlu interazzjoni ma' FIRDAPSE meta jittieħdu flimkien.
English: Overall, food slowed and decreased the absorption of amifampridine with a lowering of exposure by Cmax on average by ~44% and lowered exposure by AUC ~20%.
Maltese: B'mod globali, l-ikel ikkawża assorbiment aktar bil-mod u naqqas l-assorbiment ta' amifampridine bi tnaqqis fl-esponiment skont Cmax b'medja ta' ~44% u tnaqqis fl-esponiment skont l-AUC b'~20% abbażi ta' proporzjonijiet ġeometriċi medji (mitmugħa sa sajmin).
English: Schwannomas are generally slow-growing and can exist for months to years without producing symptoms.
Maltese: Ix-Schwannomas ġeneralment jikbru bil-mod u jistgħu jeżistu għal xhur sa snin mingħajr ma jipproduċu sintomi.
English: Amifampridine had no adverse reaction on male or female fertility in rats at doses up to 75 mg/kg/day, and no effect on post-natal development or fertility was observed in the offspring of the treated animals.
Maltese: Amifampridine ma kellu ebda effett avvers fuq il-fertilità ta' firien irġiel u nisa f'dożi sa 75 mg/kg/jum, u ma ġiet osservata l-ebda reazzjoni fuq l-iżvilupp ta' wara t-twelid jew fuq il-fertilità fil-frieħ ta' annimali ttrattati.
English: SGI Scoresb
Maltese: TAGĦRIF
English: Exposure of amifampridine was generally higher in subjects with renal impairment than in subjects with normal renal function; however, NAT2 phenotype had a greater effect on an individual's exposure to amifampridine than renal function status (See Table 4).
Maltese: Esponiment għal amifampridine ġeneralment kien ogħla f'individwi b'indeboliment renali milli f'individwi b'funzjoni renali normali; madankollu, il-fenotip NAT2 kellu effett akbar fuq l-esponiment tal-individwu għal amifampridine mill-istat tal-funzjoni renali (Ara Tabella 4).
English: Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell membrane depolarisation.
Maltese: Amifampridine jimblokka l-kanali tal-potassju dipendenti fuq il-vultaġġ, u b'hekk itawwal id-depolarizzazzjoni presinaptika tal-membrana taċ-ċelluli.
English: No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3).
Maltese: L-ebda indeboliment fuq il-fertilità ma ġie osservat fi studji mhux kliniċi b'amifampridine (ara sezzjoni 5.3).
English: The mean caffeine acetylator ratio for these 12 subjects receiving four escalating doses were 0.408 and 0.172 for fast and slow acetylators types respectively.
Maltese: Il-proporzjon medju ta' acetylator tal-kaffeina għal dawn it-12-il individwu li kienu qed jirċievu 4 dożi li jiżdiedu kien ta' 0.408 u 0.172 għat-tipi ta' acetylators mgħaġġla u bil-mod rispettivament.
English: For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended.
Maltese: F'pazjenti li jkollhom indeboliment moderat jew sever tal-funzjoni renali jew epatika hija rrakkomandata doża inizjali ta' 5 mg amifampridine (nofs pillola) darba kuljum.
English: • Blurred vision
Maltese: • Vista mċajpra,
English: The overall clearance of amifampridine is predominantly due to metabolism by N-acetylation and acetylator phenotype has a greater effect on an individual's metabolism and elimination of amifampridine than does elimination by renal function (See Table 4).
Maltese: It-tneħħija globali ta' amifampridine fil-biċċa l-kbira hija minħabba metaboliżmu permezz ta' N-acetylation u l-fenotip acetylator għandu effett akbar fuq il-metaboliżmu tal-individwu u l-eliminazzjoni ta' amifampridine minn eliminazzjoni permezz tal-funzjoni renali (Ara Tabella 4).
English: Although the metabolite is inactive at potassium channels, potential off target effects due to accumulation are unknown.
Maltese: Għalkemm il-metabolit mhux attiv fil-kanali tal-potassium, effetti potenzjali mhux fil-mira minħabba akkumulazzjoni mhux magħrufa.
English: Mean Amifampridine PK Parameters
Maltese: Doża ta' Amifampridine (mg)
English: Manufacturers EXCELLA GmbH & Co KG Nürnberger Strasse 12 90537 Feucht
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI
English: Depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects (e.g. suxamethonium) may lead to a decreased effect of both products and should be taken into consideration.
Maltese: Prodotti mediċinali depolarizzanti li jirrilassaw il-muskoli L-użu ta' amifampridine flimkien ma' prodotti mediċinali b'effetti depolarizzanti ta' rilassament tal-muskoli (eż. suxamethonium) jista' jwassal għal tnaqqis fl-effett taż-żewġ prodotti u għandu jiġi kkunsidrat.
English: Cold extremities1
Maltese: Estremitajiet kesħin1
English: Concomitant use of medicinal products with a narrow therapeutic window is contraindicated (see section 4.3).
Maltese: L-użu flimkien ta' prodotti mediċinali b'tieqa terapewtika dejqa huwa kontra-indikat (ara sezzjoni 4.3).
English: The risk of seizures is dose-dependent and is increased in patients with risk factors which lower the epileptic threshold; including use in combination with other medicinal products known to lower the epileptic threshold (see section 4.5).
Maltese: Ir-riskju tal-aċċessjonijiet huwa dipendenti fuq id-doża u jiżdied f'pazjenti li jkollhom fatturi ta' riskju li jbaxxu l-limitu epilettiku; fosthom l-użu flimkien ma' prodotti mediċinali oħra li huma magħrufa li jbaxxu l-limitu epilettiku (ara sezzjoni 4.5).
English: Abdominal pain
Maltese: ANNESS II
English: Amifampridine should be used with caution in patients with an increased risk of Schwannomas, such as patients with past medical history of such tumours, neurofibromatosis Type 2 or schwannomatosis.
Maltese: Amifampridine għandu jiġi użat b'attenzjoni f'pazjenti b'riskju miżjud ta' Schwannomas, bħal pazjenti li għandhom storja medika ta' tumuri bħal dawn, newrofibromatożi ta' Tip 2 jew schwannomatożi.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-pakkett wara JIS/EXP.
English: The pharmacodynamic profile of amifampridine has been studied for a range of doses.
Maltese: Il-profil farmakodinamiku ta' amifampridine ġie studjat għal firxa ta' dożi.
English: Stop the treatment and immediately consult your doctor in the event of:
Maltese: Waqqaf il-kura u kkonsulta immedjatament lit-tabib tiegħek f'każ ta':
English: Antiviral Activity in vitro
Maltese: Attività Antivirali in vitro
English: Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/ Lamivudine
Maltese: Soluzzjoni ta' sorbitol (3.2 g, 10.2 g, 13.4 g)/ Lamivudine
English: (e.g. Ziagen, Trizivir, Triumeq)
Maltese: (eż. Ziagen, Trizivir, Triumeq)
English: Abacavir: AUC ↔ Cmax ↓35%
Maltese: L-AUC ↔ Is-Cmax ↓35%
English: Week 4 (n = 166)
Maltese: (n = 166)
English: Children Under 25 kg:
Maltese: Tfal Inqas Minn 25 kg:
English: • hyperactivity (excessive restlessness and movement)
Maltese: • iperattività (irrekwitezza u moviment eċċessiv)
English: Abacavir + Combivir1
Maltese: Terapija Abacavir + Combivir1
English: (Inhibition of alcohol dehydrogenase)
Maltese: (Impediment ta' alkoħol dehydrogenase)
English: Median Change vRNA (log10 c/mL)
Maltese: Bidla Medja vRNA (log10 c/mL)
English: Lamivudine: AUC ↔ Zidovudine : AUC ↔
Maltese: L-AUC ↔ Zidovudine : L-AUC ↔
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain
Maltese: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spanja
English: ATC code: J05AR02.
Maltese: J05AR02
English: Tablet Core magnesium stearate microcrystalline cellulose sodium starch glycollate
Maltese: Magnesium stearate microcrystalline cellulose, sodium starch glycollate.
English: Abacavir: AUC ↑41% Ethanol: AUC ↔
Maltese: L-AUC ↑41% Ethanol:
English: Abacavir + lamivudine + PI (or PI/ritonavir)
Maltese: Abacavir + lamivudine + PI (jew PI/ritonavir)
English: Headache, paraesthesia
Maltese: Uġigħ ta' ras, parastesija
English: Musculoskeletal
Maltese: Muskuloskeletriċi
English: • methadone, used as a heroin substitute.
Maltese: • methadone użat bħala sostitut tal-eroina.
English: Lamivudine-TP and carbovir-TP (the active triphosphate form of abacavir) are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Maltese: Lamivudine-TP u carbovir-TP(il-forma tat-triphosphate attiva ta' abacavir) huma substrati u inibituri kompetittivi ta' l-HIV reverse transcriptase (RT).
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain.
Maltese: Il-Manifattur Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spanja.
English: Genotypic SS in OBT
Maltese: SS ġenotipika f' OBT
English: NAME OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Maltese: ViiV Healthcare BV
English: Myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Maltese: Mijalġja, rarament mijolisi, artralġja, żieda fil-creatine phosphokinase
English: Cmax ↓ 28%; 52%, 55%.
Maltese: AUC ↓ 14%; 32%; 36% Cmax ↓ 28%; 52%, 55%.
English: 4.6 Fertility, pregnancy and lactation
Maltese: 4.6 Fertiltà, tqala u treddigħ Tqala
English: Opadry Orange YS-1-13065-A containing: hypromellose titanium dioxide macrogol 400 polysorbate 80 sunset yellow FCF (E110)
Maltese: Opadry Orange YS-1-13065-A li fih: hypromellose titanium dioxide macrogol 400, polysorbate 80 sunset yellow FCF (E110)
English: Common: Headache, insomnia.
Maltese: Komuni: Uġigħ ta'ras,insomnja.
English: ANTI-INFECTIVE PRODUCTS Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Abacavir
Maltese: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Abacavir
English: Risk of virological failure
Maltese: Riskju ta' falliment viroloġiku:
English: Urology
Maltese: Uroloġija
English: SIDE 2
Maltese: NAĦA 2
English: • phenytoin, for treating epilepsy.
Maltese: • phenytoin, għall-kura tal-epilessija.
English: The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, stavudine, tenofovir or zidovudine, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease inhibitor (PI) amprenavir.
Maltese: L-attività antivirali ta' abacavir fil-kultura taċ-ċelloli ma ġietx antagonizzata meta kkombinat mal-inibituri reverse transcriptase nukleoside (NRTIs - nucleoside reverse transcriptase inhibitors) didanosine, emtricitabine, stavudine, tenofovir jew zidovudine, linibitur reverse transcriptase mhux nukleoside (NNRTI - non-nucleoside reverse transcriptase inhibitor) nevirapine, jew l-inibitur tal-protease (PI - protease inhibitor) amprenavir.
English: Similar clinical success (point estimate for treatment difference: -1.7, 95% CI -8.4, 4.9) was observed for both regimens.
Maltese: L-istess suċċess kliniku (point estimate għad-differenza fit-trattament: -1.7, 95% CI -8.4, 4.9) ġie osservat fiż-żewġ sistemi.
English: Proportions with HIV-1 RNA < 50 copies/ml (50% versus 47%) and < 400 copies/ml (54% versus 57%) at week 48 were also similar in each group (ITT population).
Maltese: Il-proporzjonijiet b' HIV-1 RNA < 50 kopja/ml (50% kontra 47%) u < 400 kopja/ml (54% kontra 57%) fil-ġimgħa 48 kienu simili wkoll f'kull grupp
English: Weight and metabolic parameters
Maltese: Piż u parametri metaboliċi
English: Following a single dose of 600 mg of abacavir, the mean (CV) Cmax is 4.26 µg/ml (28%) and the mean (CV) AUC∞ is 11.95 µg.h/ml (21%).
Maltese: Wara doża waħda ta' 600 mg abacavir il-medja (CV) (Cmax) hi 4.26 µg/ml (28%) u l-medja (CV) AUC∞ hi 11.95 µg.h/ml (21%).
English: Myocardial infarction
Maltese: Infart Mijokardijaku
English: Dyspnoea, cough, sore throat, adult respiratory distress syndrome, respiratory failure
Maltese: Dispnea, sogħla, uġigħ fil-griżmejn, sindromu ta' diffikultà respiratorja fl-adulti, insuffiċjenza respiratorja
English: Metabolism of lamivudine is a minor route of elimination.
Maltese: Metaboliżmu ta' lamivudine hu rotta minuri ta' eliminazzjoni.
English: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg once daily for 5 days/300 mg single dose)
Maltese: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160mg/800mg darba kuljum għal 5 ijiem/doża waħda ta'
English: The tablet coating contains Opadry Orange YS-1-13065-A containing hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and sunset yellow FCF (E110).
Maltese: Il-kisja tal-pillola fiha Opadry Orange YS-1-13065-A li fih hypromellose, titanium dioxide, macrogol 400, polysorbate 80 u sunset yellow FCF (E110).
English: Elevated liver function tests, hepatitis, hepatic failure
Maltese: Testijiet elevati tal-funzjoni tal-fwied, epatite, insuffiċjenza talfwied
English: Common: Rash, alopecia Rare: Angioedema
Maltese: Raxx, alopeċja Rari:
English: Signs of osteonecrosis include:
Maltese: Sinjali ta' osteonekrosi jinkludu:
English: - 88.3% with ABC/3TC vs 90.3% with TDF/FTC when taken with atazanavir/ritonovir as third drug, treatment difference -2.0% (95% CI -7.5%, 3.4%), - 87.4% with ABC/3TC vs 89.2% with TDF/FTC, when taken with efavirenz as third drug, treatment difference -1.8% (95% CI -7.5%, 3.9%).
Maltese: 3% b'TDF/FTC meta ttieħdu ma' atazanavir/ritonovir bħala t-tielet mediċina, differenza fil-kura -2.0% (95% CI -7.5%, 3.4%), - 87.4% b'ABC/3TC vs 89.2% b'TDF/FTC, meta tittieħdu ma' efavirenz bħala t-tielet mediċina, differenza fil-kura -1.8% (95% CI -7.5%, 3.9%).
English: Common: rash (without systemic symptoms) Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: Rari ħafna: eritema multiformi, sindromu ta' Stevens-Johnson u nekroliżi tossika epidermali
English: Zidovudine, didanosine, stavudine and tenofovir maintain their antiretroviral activities against such HIV-1 variants.
Maltese: Zidovudine, didanosine, stavudine u tenofovir iżommu lattivita' antiretrovirali tagħhom kontra dawn it-tipi ta' varjanti ta' HIV-1.
English: These belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Maltese: Dawn jagħmlu parti minn grupp ta' mediċini antiretrovirali msejħa nucleoside analogue reverse transcriptase inhibitors (NRTIs).
English: Frequencies are defined as very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100), rare (> 1/10,000 to < 1/1000), very rare
Maltese: <1/100), rari (>1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 36%).
Maltese: Lamivudine juri farmakokinetiċi lineari fuq il-firxa ta' dożi terapewtiċi u juri li jeħel b'mod limitat mal-proteini tal-plażma in vitro (<36%).
English: Common: Arthralgia, muscle disorders
Maltese: Komuni: Artralġja, mard tal muskoli
English: Respiratory tract
Maltese: Passaġġ respiratorju
English: These were primarily asymptomatic HIV infected patients (CDC stage A).
Maltese: asintomatika (CDC stadju A).
English: Percent with <400 copies/mL vRNA
Maltese: <400 kopji/mL vRNA
English: A similar virologic response was observed for both regimens (point estimate for treatment difference at week 48: 0.39%, 95% CI: -6.63, 7.40).
Maltese: Rispons viroloġiku simili kien osservat għaż-żewġ skedi ta' għoti tad-dożi (stima f'punt għad differenza fil-kura fil-ġimgħa 48: 0.39%, 95% CI: -6.63, 7.40).
English: Adults, adolescents and children weighing at least 25 kg:
Maltese: Adulti, adolexxenti u tfal li jiżnu għallinqas 25 kg:
English: Phenotypic cross-resistance to other NRTIs with M184V or M184I mutation alone is limited.
Maltese: Cross-resistance finotipika għal NRTI oħra bil-mutazzjoni M184V jew M184I waħidha hija limitata.
English: Common: hypersensitivity
Maltese: Komuni: sensittivita' eċċessiva
English: The presence of M184V with Y115F gives rise to cross-resistance between abacavir and lamivudine.
Maltese: Il-preżenza ta' M184V ma' Y115F tikkawża cross-resistance bejn abacavir u lamivudine.
English: Among the 104 patients who received Kivexa, including the ones who were between 40 kg and 25 kg, the viral suppression was similar
Maltese: Fost il-104 pazjenti li rċevew Kivexa, inkluż dawk li kienu bejn 40 kg u 25 kg, it-trażżin virali kien simili.
English: Baseline Reverse Transcriptase Mutation
Maltese: Reverse Transcriptase
English: INFORMATION IN BRAILLE kivexa
Maltese: INFORMAZZJONI BIL-BRAILLE kivexa
English: • Clinical Description of abacavir HSR
Maltese: • Deskrizzjoni Klinika ta' HSR għal abacavir
English: Phenotypic resistance and cross-resistance
Maltese: Reżistenza Finotipika u cross resistance
English: The overall selection frequency for M184V or M184I was high (54%), and less common was the selection of L74V (5%), K65R (1%) and Y115F (1%) (see table below).
Maltese: Il-frekwenza ta' selezzjoni totali għal M184V jew M184I kienet għolja (54%), u s-selezzjoni ta' L74V (5%), K65R (1%) u Y115F (1%) kienet anqas komuni (ara t-tabella hawn taħt).
English: Very rare: lactic acidosis
Maltese: Rari ħafna: Aċidożi lattika
English: IMPORTANT - Hypersensitivity reactions
Maltese: IMPORTANTI - Reazzjonijiet ta' sensittività eċċessiva
English: Additional risk minimisation activity
Maltese: Attività addizjonali għall minimizzazzjoni tar-riskji
English: (see reverse of card)
Maltese: (ara fuq wara tal-kartuna)
English: There was a low, similar overall incidence of virologic failure (viral load > 50 copies/ml) in both the once and twice daily treatment groups (10% and 8% respectively).
Maltese: Kien hemm inċidenza ġenerali simili ta' indeboliment viroloġiku, li kienet baxxa, (viral load>50 kopji/ml) fiż-żewġ gruppi ta' trattament b'darba u darbtejn kuljum (10% u 8% rispettivament).
English: Total
Maltese: Totali
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Maltese: Il-half life ta' l-eliminazzjoni ta' lamivudine osservata hi minn 5 sa 7 sigħat.
English: Mechanism of action: Abacavir and lamivudine are NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2 (LAV2 and EHO) replication.
Maltese: Abacavir u lamivudine huma NRTIs, u huma inibituri potenti selettivi kontra r-replikazzjoni tal-HIV-1 u l-HIV-2 (LAV2 u EHO).
English: Abacavir is primarily metabolised by the liver.
Maltese: Abacavir huwa primarjament metabolizzat mill-fwied.
English: Baseline CD4 category <50
Maltese: Kategorija ta' CD4 <50 fil-linja bażi
English: Single dose lamivudine oral solution 300 mg
Maltese: Doża waħda lamivudine soluzzjoni orali 300 mg Lamivudine:
English: Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Maltese: HSR huma deni (~80%), raxx (~70%), sintomi gastrointestinali (>50%) bħal dardir, uġigħ addominali, rimettar, u dijarea, telqa ġeneralizzata, għeja, u uġigħ ta' ras (~50%) u sintomi oħra (~30%) bħal sintomi respiratorji, tal-mukuża, u muskolu-skeletali.
English: In a meta-analysis of five clinical trials where ABC was added to intensify therapy, of 166 subjects, 123 (74%) had M184V/I, 50 (30%) had T215Y/F, 45 (27%) had M41L, 30 (18%) had K70R and 25 (15%) had D67N.
Maltese: F'meta-analiżi ta' ħames studji kliniċi fejn żdied ABC biex iqawwi t terapija, ta' 166 individwu, 123 (74%) kellhom M184V/I, 50(30%) kellhom T215Y/F, 45 (27%) kellhom M41L, 30 (18%) kellhom K70R u 25 (15%) kellhom D67N.
English: 1 Major IAS-USA (Dec 2009) defined mutations for Abacavir or Lamivudine
Maltese: 1 Mutazzjonijiet prinċipali ddefiniti minn IAS-USA (Diċ 2009) għal Abacavir jew Lamivudine
English: Hypersensitivity reactions (see also section 4.8 )
Maltese: Reazzjonijiet ta' sensittività eċċessiva (ara wkoll sezzjoni 4.8):
English: See sections 4.4 and 4.8.
Maltese: 4.4 u 5.1).
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 administered dose.
Maltese: Ir-rotot ewlenin talmetaboliżmu fil-bniedem huma bl-alkohol dehydrogenase u bi glukoronidazzjoni sabiex jiproduċu 5'carboxylic acid u 5'-glucuronide li jirrappreżentaw 66% tad-doża li tingħata.
English: Phenotypic susceptibility analyses of clinical isolates from antiretroviral-naïve patients with HIV-1 Group M non-B subtypes in three studies have each reported that all viruses were fully susceptible to both abacavir and lamivudine; one study of 104 isolates that included subtypes A and A1 (n=26), C (n=1), D (n=66), and the circulating recombinant forms (CRFs) AD (n=9), CD (n=1), and a complex inter-subtype recombinant_cpx (n=1), a second study of 18 isolates including subtype G (n=14) and CRF_AG (n=4) from Nigeria, and a third study of six isolates (n=4 CRF_AG, n=1 A and n=1 undetermined) from Abidjan (Côte d'Ivoire).
Maltese: Analiżi ta' suxxettibiltà fenotipika ta' iżolati kliniċi minn pazjenti li qatt ma ħadu kura antiretrovirali qabel b'sottotipi tal-Grupp M mhux B ta' HIV-1 f'kull wieħed minn tliet studji rrappurtaw li l-virusis kollha kienu kompletament suxxettibbli kemm għal abacavir kif ukoll għal lamivudine; studju wieħed ta' 104 iżolati li inkluda sottotipi A u A1 (n=26), C (n=1), D (n=66), u l-forom rikombinanti li jiċċirkulaw (CRFs) AD (n=9), CD (n=1), u cpx rikombinanti kumpless ġo sottotip (n=1), it-tieni studju ta' 18-il iżolat li kien jinkludi s-sottoptip G (n=14) u CRF_AG (n=4) minn Niġerja, u t-tielet studju ta'
English: HIV-1 isolates (CRF01_AE, n=12; CRF02_AG, n=12; and Subtype C or CRF_AC, n=13) from 37 untreated patients in Africa and Asia were susceptible to abacavir (IC50 fold changes <2.5), and lamivudine (IC50 fold changes<3.0), except for two CRF02_AG isolates with fold-changes of 2.9 and 3.4 for abacavir.
Maltese: Iżolati ta' HIV-1 (CRF01_AE, n=12; CRF02_AG, n=12; u s-Sottotip C jew CRF_AC, n=13) minn 37 pazjent fl-Afrika u fl-Asja li ma kinux ikkurati kienu suxxettibbli għal abacavir (drabi ta' bidla flIC50 <2.5), u lamivudine (drabi ta' bidla fl-IC50<3.0), minbarra żewg iżolati CRF02_AG bi drabi ta'
English: ABC HSR Education Programme has been in place since the first approval of ABC as the single active preparation, ZIAGEN (USA December 1998, EU July 1999).
Maltese: HSR ilu fis-seħħ mill-ewwel approvazzjoni ta' ABC bħala preparazzjoni attiva waħdanija, ZIAGEN (l-Istati Uniti tal-Amerika Diċembru 1998, l-UE Lulju
English: Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side.
Maltese: Pilloli oranġjo, miksijin b'rita, modifikati forma ta' kapsula, u fuq naħa minnhom għandhom imnaqqax GS FC2