FrancophonIA/ELRC3.0 huggingface dataset:
English: They include some common medicines and a herbal remedy (St. John's wort) which can cause serious interactions.
Maltese: Jinkludu mediċini komuni u rimedju erbali (St. John's wort) li jistgħu jikkawżaw interazzjonijiet serji.
English: At baseline, median plasma HIV-1 RNA was 5.88 log10 copies/mL, median CD4+ cell count was 1144 cells/mm3, and median CD4+ percentage was 25%.
Maltese: Fil-linja bażi, il-medjan tal-RNA tal-HIV-1 fil-plażma kien 5.88 log10 kopja/mL, ilmedjan tal-għadd ta' ċelluli CD4+ kien 1144 ċellula/mm3, u l-medjan tal-perċentwali ta' CD4+ kien 25%.
English: Implant: Etonogestrel/Efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Maltese: Etonogestrel/Efavirenz Tista' tkun mistennija espożizzjoni mnaqqsa ta' etonogestrel (induzzjoni ta' CYP3A4).
English: No clinically significant pharmacokinetic interaction.
Maltese: Ebda interazzjoni farmakokinetika klinikament sinifikanti.
English: 9 If the daily dose consists of more than one capsule, follow steps 5-8 for each capsule.
Maltese: 9 Jekk id-doża ta' kuljum tikkonsisti minn iktar minn kapsula waħda, segwi l-passi 5-8 għal kull kapsula.
English: Study PACTG 1021 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive.
Maltese: Studju PACTG 1021 kien studju open-label biex jevalwa l-farmakokinetika, is-sigurtà, it-tollerabbiltà, u l-attività antivirali ta' SUSTIVA flimkien ma' didanosine u emtricitabine f'pazjenti pedjatriċi li qatt ma ħadu t-terapija antiretrovirali qabel.
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Maltese: Għandu jintuża metodu affidabbli ta' kontraċezzjoni barriera flimkien mal-kontraċettivi ormonali (ara sezzjoni 4.6).
English: SUSTIVA may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Maltese: SUSTIVA jista' jinteraġġixxi ma' mediċini oħrajn, inkluż preparazzjonijiet erbali bħall-estratti ta' Ginkgo biloba.
English: In clinical studies, 26% of patients treated with 600 mg of efavirenz experienced skin rash compared with 17% of patients treated in control groups.
Maltese: Fi studji kliniċi, 26 % tal-pazjenti kkurati b'600 mg ta' efavirenz kellhom raxx fil-ġilda meta mqabbla ma' 17 % ta' pazjenti kkurati fil-gruppi ta' kontroll.
English: Buprenorphine/naloxone/Efavirenz Buprenorphine: AUC: ↓ 50%
Maltese: Buprenorphine/naloxone/Efavirenz Buprenorphine:
English: Rash was reported more frequently in children (59 of 182 (32%) treated with efavirenz) and was more often of higher grade than in adults (severe rash was reported in 6 of 182 (3.3%) of children).
Maltese: Ir-raxx kien iktar irrapportat fit-tfal (59 minn 182 (32%) ikkurati b'efavirenz) u kien ta' grad ogħla iktar ta' spiss milli fl-adulti (raxx sever kien irrapportat f'6 minn 182 (3.3%) tifel u tifla).
English: PHARMACEUTICAL FORM AND CONTENTS 30 x 1 film-coated tablets
Maltese: FARMAĊEWTIKA U KONTENUT 30 x 1 pillola miksija b'rita
English: NAME OF THE MEDICINAL PRODUCT SUSTIVA 50 mg hard capsules SUSTIVA 100 mg hard capsules SUSTIVA 200 mg hard capsules
Maltese: SUSTIVA 50 mg kapsuli ibsin SUSTIVA 100 mg kapsuli ibsin SUSTIVA 200 mg kapsuli ibsin
English: Capsule core: Sodium laurilsulfate, Lactose monohydrate, Magnesium stearate, Sodium starch glycolate
Maltese: Il-qalba tal-kapsula: Sodium laurilsulfate, Lactose monohydrate, Magnesium stearate, Sodium starch glycolate
English: Interactions between efavirenz and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, and once every 8 or 12 hours as “q8h” or “q12h”).
Maltese: L-interazzjonijiet bejn efavirenz u l-inibituri protease, sustanzi antiretrovirali li mhumiex inibituri protease u prodotti mediċinali oħra li mhumiex anti-retrovirali huma elenkati f'Tabella 2 hawn isfel (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, ebda bidla bħala “↔”, u darba kull 8 jew 12-il siegħa bħala “q8h” jew “q12h”).
English: Integrase strand transfer inhibitor
Maltese: Sindromu tar-Rijattivazzjoni Immunitarja
English: Each film-coated tablet contains 249.6 mg of lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 249.6 mg ta' lactose (bħala monohydrate).
English: Table 1: Paediatric dose to be administered once daily*
Maltese: Tabella 1: Doża pedjatrika li trid tingħata darba kuljum*
English: Cmax: ↔ 11% (CYP3A induction - effect on boceprevir) *0-8 hours
Maltese: AUC: ↔ 20% Cmax: ↔ 11% (induzzjoni ta' CYP3Aeffett fuq boceprevir) *0-8 sigħat
English: Printing ink: Cochineal carminic acid (E120), Indigo carmine (E132), Titanium dioxide (E171)
Maltese: Linka tal-istampar: Cochineal carminic acid (E120), Indigo carmine (E132), Titanium dioxide (E171)
English: Reported rates of recurrent rash following a switch from nevirapine to efavirenz therapy, primarily based on retrospective cohort data from published literature, range from 13 to 18%, comparable to the rate observed in patients treated with efavirenz in clinical studies.
Maltese: Ir-rati rrappurtati ta' raxx rikorrenti wara bidla minn terapija b'nevirapine għal terapija b'efavirenz, ibbażati primarjament fuq dejta retrospettiva ta' gruppi minn letteratura medika ppubblikata, kienu fuq medda bejn 13 u 18 %, kumparabbli mar-rata osservata f'pazjenti kkurati b'efavirenz fi studji kliniċi.
English: Cmax: ↑ 49% (↑ 32 to ↑ 69)
Maltese: Cmax: ↑ 49% (↑ 32 għal ↑
English: Limited data suggest there is no clinically significant effect on valproic acid pharmacokinetics.
Maltese: Dejta limitata tissuġġerixxi li ma hemm ebda effett klinikament sinifikanti fuq ilfarmakokinetiċi tal-aċidu valprojku.
English: Plasma levels of efavirenz can be reduced by concomitant use of St. John's wort due to induction of drug metabolising enzymes and/or transport proteins by St. John's wort.
Maltese: John's wort minħabba l-induzzjoni ta' enzimi li jimmetabolizzaw il-mediċini u/jew jittrasportaw il-proteini permezz ta' St.
English: Uncommon (affects 1 to 10 users in 1,000) nervousness, forgetfulness, confusion, fitting (seizures), abnormal thoughts blurred vision a feeling of spinning or tilting (vertigo) pain in the abdomen (stomach) caused by inflammation of the pancreas allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome) yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver breast enlargement in males angry behaviour, mood being affected, seeing or hearing things that are not really there (hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts, catatonia (condition in which the patient is rendered motionless and speechless for a period) whistling, ringing or other persistent noise in the ears tremor (shaking) flushing
Maltese: Mhux komuni (jaffettwaw utent wieħed sa 10 minn kull 1,000) nervożiżmu, tinsa l-affarijiet, konfużjoni, attakki (aċċessjonijiet), ħsibijiet mhux normali viżta mċajpra sensazzjoni ta' tidwir jew għelib (vertiġni) uġigħ fl-istonku kkawżat minn infjammazzjoni tal-frixa reazzjoni allerġika (sensittività eċċessiva) li tista' tikkawża reazzjonijiet severi tal-ġilda (ertema multiforme, is-sindromu ta' Stevens-Johnson) ġilda jew għajnejn sofor, ħakk, jew uġigħ fl-istonku kkawżat minn infjammazzjoni tal-fwied tkabbir tas-sider fl-irġiel imġiba ta' rabja, tibdil fil-burdati, tara u tisma' affarijiet li mhumiex veru hemm (alluċinazzjonijiet), manija (kundizzjoni mentali kkaratterizzata minn episodji ta' attività eċċessiva, ferħ kbir jew irritabbiltà), paranoja, ħsibijiet ta' suwiċidju, katatonja (kundizzjoni li fiha l-pazjent jispiċċa ma jistax jiċċaqlaq u ma jistax jitkellem għal perjodu ta' żmien). tisfir, żarżir jew xi ħoss persistenti ieħor fil-widnejn tregħid fwawar
English: The single substitutions which led to the highest resistance to efavirenz in cell culture correspond to a leucine-to-isoleucine change at position 100 (L100I, 17 to 22-fold resistance) and a lysine-to-asparagine at position 103 (K103N, 18 to 33-fold resistance).
Maltese: Is-sostituzzjonijiet singoli li wasslu għall-ogħla reżistenza għal efavirenz fil-kulturi taċ-ċelluli jikkorrispondu għall-bidla minn leucine għal isoleucine f'pożizzjoni 100 (L100I, reżistenza minn 17 sa 22 darba iktar) u bidla minn lysine għal asparagine fil-pożizzjoni 103 (K103N, reżistenza minn 18 sa 33 darba iktar).
English: What SUSTIVA looks like and contents of the pack SUSTIVA 200 mg hard capsules are supplied in bottles of 90 capsules and in packs containing 42 x 1 capsules in aluminium/PVC perforated unit dose blisters.
Maltese: Il-Kapsuli SUSTIVA tal-200mg jiġu fi fliexken ta' 90 Kapsula u f'pakketti li fihom 42 x 1 Kapsula f'folji tal-aluminju/PVC mtaqqab għal dożi waħedhom.
English: Cmax: ↑ 11% (↑ 3 to ↑ 19)
Maltese: Cmax: ↑ 11% (↑ 3 għal ↑
English: Bupropion: AUC: ↓ 55% (↓ 48 to ↓ 62)
Maltese: AUC: ↓ 55% (↓ 48 sa
English: Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy,breast-feeding and fertility).
Maltese: Kontraċettiv ormonali, bħal pilloli ta' kontroll tat-twelid, kontraċettiv injettat (per eżempju, Depo-Provera), jew kontraċettiv impjantat (per eżempju, Implanon): għandek tuża wkoll metodu ta' kontraċezzjoni barriera affidabbli (ara Tqala, treddigħ u fertilità).
English: Cmax: ↑ 38%
Maltese: AUC: ↑ 44% Cmax: ↑ 38%
English: Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (21/37) and 46% (17/37), respectively.
Maltese: ITT, il-proporzjonijiet globali ta' pazjenti b'<400 kopja/mL u <50 kopja/mL tal-RNA tal-HIV fil-Ġimgħa 48 kienu 57% (21/37) u 46% (17/37), rispettivament.
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood.
Maltese: Hija mediċina antiretrovirali li tissielet infezzjoni bil-virus tal-immunodefiċjenza umana (HIV-1) billi tnaqqas l-ammont ta' virus fid-demm.
English: The mechanism of the effect on velpatasvir is induction of CYP3A and CYP2B6 by efavirenz.
Maltese: Ilmekkaniżmu tal-effett fuq velpatasvir huwa induzzjoni ta' CYP3A u CYP2B6 minn efavirenz.
English: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or
Maltese: Kienu osservati wkoll sostituzzjonjiet fil-pożizzjonijiet RT 98, 100, 101, 108, 138, 188, 190 jew 225, imma fil-frekwenzi iktar baxxi u ħafna drabi biss flimkien ma' K103N.
English: CARDIOVASCULAR AGENTS Calcium Channel Blockers Diltiazem/Efavirenz (240 mg once daily/600 mg once daily)
Maltese: Imblokkaturi tal-Kanali tal-Kalċju Diltiazem/Efavirenz (240 mg darba kuljum/600 mg darba kuljum)
English: The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969).
Maltese: Il-kategorija ta' frekwenza "rari" ġiet definita skont il-gwida Linja Gwida dwar isSommarju tal-Karateristiċi tal-Prodott (SmPC) (rev. 2, Sett 2009) fuq il-bażi ta' stima tal-upper bound tal-intervall ta' kunfidenza ta' 95 % għal każijiet 0 meta jitqiesu n-numru ta' individwi kkurati b'efavirenz f'dawn il-provi kliniċi (n=3,969).
English: SUSTIVA 600 mg film-coated tablets are also supplied in packs containing 30 x 1 or multipacks of 90 (3 packs of 30 x 1) tablets in aluminium/PVC perforated unit dose blisters.
Maltese: SUSTIVA 600 mg pilloli miksija b'rita huma fornuti wkoll f'pakketti li fihom 30 x 1 pakketti multipli ta' 90 (3 pakketti x 30 x 1) pillola f'folji tal-aluminju mtaqqab għal dożi waħedhom.
English: Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
Maltese: L-esponiment għal efavirenz jista' jiżdied meta jingħata ma' prodotti mediċinali (per eżempju, ritonavir) jew ikel (per eżempju, meraq tal-grejpfrut), li jinibixxu l-attività ta' CYP3A4 jew CYP2B6.
English: Each hard capsule contains 28.5 mg of lactose (as monohydrate).
Maltese: Kull kapsula iebsa fiha 28.5 mg ta' lactose (bħala monohydrate).
English: This mutation was observed in 90% of patients receiving efavirenz with virological failure.
Maltese: Din il-mutazzjoni kienet osservata f'90 % mill-pazjenti li kienu qed jingħataw efavirenz b'falliment viroloġiku.
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Bristol-Myers Squibb Pharma EEIG Plaza 254
English: Greater than 100-fold loss of susceptibility was observed against HIV variants expressing K103N in addition to other amino acid substitutions in RT.
Maltese: Kien osservat telfien tas-suxxettibilità għal mitt darba kontra varjanti tal-HIV li kellhom K103N apparti sostituzzjonijiet oħra ta' amino acid f'RT.
English: Efavirenz plasma exposure may be increased in patients with the homozygous G516T genetic variant of the CYP2B6 isoenzyme.
Maltese: L-esponiment tal-plażma ta' efavirenz jista' jkun ogħla f'pazjenti bil-varjant ġenetiku omozigota G516T tal-isoenzima CYP2B6.
English: Bristol-Myers Squibb GmbH & CO. KGaA Tel: +49 89 121 42-0
Maltese: KGaA Tel: +49 89 121 42-0
English: EU/1/99/110/010 - blister
Maltese: EU/1/99/110/010 - folja
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Maltese: Ħafna minn Rosuvastatin huwa eliminat mhux mibdul permezz tal-eskreta, għalhekk mhijiex mistennija interazzjoni ma' efavirenz.
English: Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days (see section 4.5).
Maltese: Skont ir-relazzjoni bejn il-konċentrazzjoni u lQTc, il-medja tat-titwil tal-QTc u tal-limitu ta' fuq tal-intervall ta' kunfidenza ta' 90% tiegħu huma 8.7 ms u 11.3 ms f'individwi b'ġenotip CYP2B6*6/*6 wara l-għoti ta' doża ta' kuljum ta' 600 mg għal 14-il jum (ara s-sezzjoni 4.5).
English: Nelfinavir/Efavirenz (750 mg q8h/600 mg once daily)
Maltese: Nelfinavir/Efavirenz (750 mg q8h/600 mg darba kuljum)
English: Elevations of GGT to greater than five times ULN were observed in 4% of all patients treated with 600 mg of efavirenz and 1.5-2% of patients treated with control regimens (7% of efavirenz-treated patients and 3% of control-treated patients after long-term treatment).
Maltese: Ġew osservati elevazzjonijiet simili f'pazjenti kkurati b'GGT għal iktar minn ħames darbiet l-ULN f'4% mill-pazjenti kollha kkurati b'600 mg ta' efavirenz u 1.5 - 2 % tal-pazjenti f'kuri ta' kontroll (7% ta' tal-pazjenti kkurati b'efavirenz u 3% ta' pazjenti f'kuri ta' kontroll wara kura fit-tul).
English: A similar reduction in indinavir exposures was observed when indinavir 1000 mg q8h was given with efavirenz 600 mg daily.
Maltese: Tnaqqis simili flespożizzjonijiet għal indinavir ġew osservati meta indinavir 1.000 mg q8h ingħata flimkien ma' efavirenz 600 mg kuljum Efavirenz:
English: Metabolism and nutrition disorders common hypertriglyceridaemia*
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni ipertrigliċeridemija*
English: Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme; psychiatric adverse reactions including severe depression, death by suicide, and psychosis like behaviour; and seizures have been reported in patients treated with efavirenz.
Maltese: Reazzjonijiet qawwija fil-ġilda bħas-sindrome ta' Stevens-Johnson u eritema multiforme; reazzjonijiet avversi psikjatriċi li jinkludu dipressjoni qawwija, mewt minħabba suwiċidju, u mġiba li qisha psikotika; u aċċessjonijiet kienu rrapportati f'pazjenti kkurati b'efavirenz.
English: Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni għal reazzjonijiet avversi marbuta mad-doża, speċjalment sintomi tas-sistema nervuża (ara sezzjonijiet 4.3 u 4.4).
English: SUSTIVA may make hormonal contraceptives less likely to work.
Maltese: SUSTIVA jista' jagħmel lill-kontraċettivi ormonali inqas probabbli li jaħdmu.
English: In HIV-1 infected patients (n = 6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data.
Maltese: F'pazjenti infettati blHIV-1 (n = 6), ilfarmakokinetiċi ta' indinavir u efavirenz kienu ġeneralment komparabbli ma' din iddejta dwar voluntiera mhux infettati.
English: Indinavir/Efavirenz (800 mg q8h/200 mg once daily)
Maltese: Indinavir/Efavirenz (800 mg q8h/200 mg darba kuljum)
English: Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild hepatic impairment.
Maltese: Minħabba l-metaboliżmu estensiv ta' efavirenz li hu medjat minn cytochrome P450, u minħabba l-esperjenza klinika limitata f'pazjenti b'mard kroniku fil-fwied, għandu jkun hemm kawtela meta wieħed jagħti efavirenz lil pazjenti b'indeboliment ħafif tal-fwied.
English: Patients with: - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
Maltese: Pazjenti bi: - storja fil-familja ta' mewt f'daqqa jew ta' titwil konġenitali tal-intervall QTc fuq lelettrokardjogrammi, jew bi kwalunkwe kondizzjoni klinika oħra magħrufa li ttawwal l-intervall QTc.
English: Study Number/ Treatment Regimensb n % (95% C.I.c)
Maltese: Numru tal-istudju/ Tipi ta' Kura n % (95 % C.
English: The bioavailability of a single 600 mg dose of efavirenz hard capsules in uninfected volunteers was increased 22% and 17%, respectively, when given with a meal of high fat or normal composition, relative to the bioavailability of a 600 mg dose given under fasted conditions (see section 4.4).
Maltese: Il-bijodisponibbiltà ta' doża waħda ta' kapsuli ibsin ta' 600 mg ta' efavirenz f'voluntiera mhux infettati żdiedet minn 22 % għal 17 % rispettivament, meta mogħti ma' ikla b'livell għoli ta' xaħam jew kompożizzjoni normali, meta mqabbel mal-bijodisponibbilta` ta' doża ta' 600 mg mogħtija f'kondizzjonijiet ta' sawm (ara sezzjoni 4.4).
English: The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, and magnesium stearate.
Maltese: L-ingredjenti l-oħra fil-qalba tal-pillola huma: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, u magnesium stearate.
English: AUC: ↓ 60% (↓ 52 to ↓ 68)
Maltese: AUC: ↓ 60% (↓ 52 għal ↓
English: The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172) and carnauba wax.
Maltese: Ir-rita tal-kisi fiha: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide isfar (E172), u xama' tal-carnauba.
English: Famotidine/Efavirenz (40 mg single dose/400 mg single dose)
Maltese: Famotidine/Efavirenz (40 ng doża waħda/400 mg doża waħda)
English: Each SUSTIVA hard capsule contains 200 mg of the active substance efavirenz.
Maltese: Kull kapsula SUSTIVA fiha 200 mg tas-sostanza attiva efavirenz.
English: Using an ITT analysis, the overall proportion of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (58/102) and 43% (44/102), respectively.
Maltese: ITT, il-proporzjonijiet ġenerali ta' pazjenti b'<400 kopja/mL u <50 kopja/mL tal-RNA tal-HIV fil-Ġimgħa 48 kienu 57% (58/102) u 43% (44/102), rispettivament.
English: If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible efavirenz levels.
Maltese: John's wort, iċċekkja l-livelli virali u jekk possibbli l-livelli ta' efavirenz.
English: Clinically significant interactions are not expected since vigabatrin and gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Maltese: Mhumiex mistennija interazzjonijiet klinikament sinifikanti billi vigabatrin u gabapentin jitneħħew esklussivament mhux mibdula fl-awrina u mhumiex probabbli li jikkompetu għall-istess enzimi metaboliċi u passaġġi ta' eliminazzjoni bħal efavirenz.
English: EU/1/99/110/009 - blister
Maltese: EU/1/99/110/009 - folja
English: INFORMATION IN BRAILLE SUSTIVA 600 mg
Maltese: SUSTIVA 600 mg
English: Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 77% (33/43) and 70% (30/43), respectively.
Maltese: ITT, il-proporzjonijiet ġenerali ta' pazjenti b'<400 kopja/mL u <50 kopja/mL tal-RNA tal-HIV fil-Ġimgħa 48 kienu 77% (33/43) u 70% (30/43), rispettivament.
English: Study AI266922 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with didanosine and emtricitabine in antiretroviral-naive and -experienced paediatric patients.
Maltese: Studju AI266922 kien studju open-label għall-evalwazzjoni tal-farmakokinetika, is-sigurtà, ittollerabbiltà, u l-attività antivirali ta' SUSTIVA flimkien ma' didanosine u emtricitabine f'pazjenti pedjatriċi li qatt ma ħadu t-terapija antiretrovirali qabel u oħrajn b'esperjenza għal terapija antiretrovirali.
English: Antimalarials
Maltese: ANTIKOAGULANTI
English: The incidence of erythema multiforme or StevensJohnson syndrome was approximately 0.1%.
Maltese: L-inċidenza ta' eritema multiforme jew issindromu ta' Stevens-Johnson kien ta' bejn wieħed u ieħor 1 %.
English: SUSTIVA 50 mg hard capsules efavirenz
Maltese: SUSTIVA 50 mg kapsuli ibsin efavirenz
English: Liver enzymes: elevations of AST and ALT to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients treated with 600 mg of efavirenz (5-8% after longterm treatment in study 006).
Maltese: Enzimi tal-fwied: fi 3% ta' 1,008 pazjenti li ngħataw 600 mg ta' efavirenz (5-8% wara kura fit-tul fi studju 006) dehru livelli ta' AST u ALT li għolew għal iktar minn ħames darbiet il-livell ta' fuq talmedda normali (ULN).
English: Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/Efavirenz (50 mg once daily/600 mg once daily)
Maltese: Inibituri Selettivi tat-Teħid mill-ġdid ta' Serotonin (SSRIs) Sertraline/Efavirenz (50 mg darba kuljum/600 mg darba kuljum)
English: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenzcontaining fixed-dose combination tablets) in the first trimester.
Maltese: Kien hemm seba' rapporti retrospettivi ta' sejbiet konsistenti ma' difetti fit-tubu tan-nervituri, inkluż meningomajelosil, kollha f'ommijiet esposti għal korsijiet li kien fihom efavirenz (eskluż kwalunkwe pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz) fl-ewwel trimestru.
English: Hepatic impairment
Maltese: Każijiet epatiċi
English: Hepatitis C antivirals Boceprevir/Efavirenz (800 mg 3 times daily/600 mg once daily)
Maltese: Antivirali tal-Epatite Ċ Boceprevir/Efavirenz (800 mg 3 darbiet kuljum/600 mg darba kuljum)