FrancophonIA/ELRC3.0 huggingface dataset:
English: Dutch Farm International B.V. Nieuw Walden 112 1394 PE
Maltese: L-Olanda Dutch Farm International B.V.
English: Doxycyclin 50 Dopharma
Maltese: Doxycyclin 50
English: Indications: for the treatment of poultry: ornythosis, caused by Clamydia psittaci, colibacteriosis caused by E. coli, CRD caused by Mycoplasma gallisepticum
Maltese: Għattrattament ta' tjur: ornitożi, ikkawżata minn Clamydia psittaci, kolibakterijożi kkawżata minn E. coli, CRD ikkawżata minn Mycoplasma gallisepticum
English: Calves, porcine, poultry
Maltese: Majjali, tjur, għoġġiela
English: Meat - 7 days
Maltese: Laħam - 7 jiem
English: Broiler: 20 mg of doxycycline / per 1 kg b.w.
Maltese: Brojler: 20 mg ta' doxycycline / kull 1 kg b.w.(kull 35 jiem) Majjali:
English: Chicken younger than 2 weeks: 1 g powder/1 litre of drinking water/day.
Maltese: Tiġieġ iżgħar minn ġimagħtejn: 1 g/trab/1 litru ta' ilma tax-xorb/jum.
English: Chickens (broilers): Meat and offal: 7 days.
Maltese: Tiġieġ (Brojlers) laħam u offal: 7 jiem.
English: Chickens(broilers): Meat and offal: 7 days.
Maltese: Tiġieġ (brojlers) Laħam u offal: 7 jiem.
English: In the confirmatory phase, both the clinical and pathological response to artificial O. rhinotracheale infection was low in un-medicated controls.
Maltese: Fil-fażi ta' konferma, kemm ir-rispons kliniku u dak patoloġiku għal infezzjoni artifiċjali b'O. rhinotracheale kien baxx fil-kontrolli mhux medikati.
English: 10-20 mg doxycyclini hyclas/ kg bw/ day
Maltese: -20 mg doxycycline hytclas /kg bw/jum
English: 10% Oral solution
Maltese: 10 % Soluzzjoni Orali
English: w. correspondin g to 50-100 g product/100 liter d.w.
Maltese: Tjurbrojlers: 57,5 g prodott/10 litru ta' ilma tax-xorb Dundjani:10 -20mg sustanza attiva /b. w. li tikkorrispond i għal 50100 g prodott/100 litru d.w.
English: Chronic respiratory disease, infections caused by Pasteurella spp., Mycoplasma spp., Salmonella spp., E.
Maltese: Mard kroniku respiratorju, infezzjonijiet ikkawżati minn Pasteurella spp., Mycoplasma spp., Salmonella spp., E. coli, Haemophillus paragallinarium, Staphylococcus, epatite kkawżata minn Campylobacter u dermatite.
English: Oral (drinking water)
Maltese: Orali (ilma tax-xorb)
English: Non-egg laying chickens:Pasteurellosi s caused by Pasteurella multocida: 10 mg doxycycline hyclate per kg bodyweight per day for days.infectio ns caused by Ornithobacte rium rhinotracheal e (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days
Maltese: 10-20 mg doxycycline hyclate attiv/kg b.w.)/jum, trattament kontinwu: 1 g prodott/ 36 litru ilma tax-xorb, trattament riġetut: 2550 mg prodott/kg b.w.(10-20 mg doxycycline hyclate/kg b.w.) fl-ilma tax-xorb
English: 500mg/g Powder for oral solution
Maltese: 500mg/g Trab għal soluzzjoni orali
English: Pigs and chickens (broilers).
Maltese: Klamidijożi (Chlamydia psittaci).
English: In conclusion, a therapeutic dose of 20 mg/kg body weight administered for 5 consecutive days was confirmed for the treatment of respiratory disease caused by M. gallisepticum in chicken, on basis of a clinical field study in broiler chickens with respiratory disease and confirmed M. gallisepticum infection.
Maltese: B'konklużjoni, doża terapewtika ta' 20 mg/kg ta' piż tal-ġisem amministrata għal 5 jiem konsekuttivi kienet ikkonfermata għat-trattament ta' mard respiratorju kkawżat minn M.
English: DOXICHEM Doxycycline hyclate
Maltese: LI FIHOM DOXYCYLINE HYCLATE
English: 25 mg doxycycline/ kg bw/day, for 3-5 days.
Maltese: 25 mg doxycycline/ kg bw/jum, għal 3-5 jiem
English: Belgium Huvepharma N.V. Uitbreidingstraat
Maltese: Il-Belġju Huvepharma N.V. Uitbreidingstraat
English: 100 g of product/100 0 litres drinking water for 5 days
Maltese: 100 g ta' prodott /1000 litru ilma taxxorb għal 5 jiem
English: Meat and offal: chicken treated with 10 mg/kg bw: 5 days, chicken treated with 20 mg/kg bw: 12 days.
Maltese: Tiġieġ ikkurat b'10 mg/kg bw: 5 jiem, tiġieġ ikkurat b'20 mg/kg bw: 12 jiem.
English: Doxycycline hyclate 500 mg. (equivalent to 433,3 mg of Doxiclina) per 1 g. of product
Maltese: (ekwivalenti għal 433,3 mg ta' Doxiclina) kull 1 g. ta' prodott
English: Chickens (broilers)meat: 7 days.
Maltese: Tiġieġ (brojlers)laħam: 7 jiem.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics
Maltese: KONKLUŻJONIJIET U RAĠUNIJIET XJENTIFIĊI GĦAL EMENDI TAS-SOMMARJU TAL-KARATTERISTIĊI
English: 5 g produkt/ 100 kg bw/ day or 0,5 g / 1 liter of drinking water
Maltese: 20 g/100 g Trab orali tiġieġ (brojler) 5 g prodott/ 100 kg bw/jum jew 0,5 g/ 1 litru ta' ilma tax-xorb
English: Hungary DOPHARMA B.V. Zalmweg 24,
Maltese: L-Ungerija DOPHARMA B.V. Zalmweg 24,
English: Chickens
Maltese: Fleminga
English: Oral 3-5 days
Maltese: 3 - 5 jiem Indikazzjonijiet:
English: for consecutive days or 2 g of product /10 litres drinking water and equivalent to 100 mg of doxycycline /litre of drinking water
Maltese: 15 mg doxycycline /kg b.w. għal 5 jiem konsekuttivi jew 2 g ta' prodott /10 litri ilma taxxorb u ekwivalenti għal 100 mg ta' doxycycline /litru ta' ilma tax-xorb
English: 1 ml/20 kg bw/day dissolved in the drinking water.
Maltese: 1 ml /20 kg bw/jum maħlul flilma tax-xorb.
English: Date of opening: _______
Maltese: Data tal-ftuħ: _________
English: Test Reference
Maltese: Test Referenza
English: 3, catatonia
Maltese: 3, katatonja
English: Tablet dimension: 20 x 11 mm.
Maltese: Id-dimensjoni tal-pillola hi 20 x 11 mm.
English: Modified LOCF
Maltese: LOCF modifikat
English: Common: - anorexia
Maltese: Komuni: - anoreksja
English: GMR (%) (90%CI) Test Reference
Maltese: (90% CI) Test Referenza
English: , neurosis
Maltese: , nevrożi
English: Total active HMG Co-A reductase inhibitors:
Maltese: Impedituri attivi totali HMG Co-A reductase:
English: EU/1/17/1263/001 30 film-coated tablets EU/1/17/1263/002 90 (3 x 30) film-coated tablets
Maltese: EU/1/17/1263/001 30 pillola miksija b'rita EU/1/17/1263/002 90 (3 x 30) pillola miksija b'rita
English: Verapamil, Felodipine, Nifedipine and
Maltese: Verapamil, Felodipine, Nifedipine u Nicardipine
English: (CYP3A4 induction
Maltese: (Induzzjoni ta' CYP3A4)
English: 3, affect lability confusional state aggression
Maltese: 3, stat konfużjonali aggressjoni
English: Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Maltese: Żviluppa raxx f'46% tal-voluntiera mhux infettati li rċevew efavirenz u clarithromycin.
English: Table 6: Summary of pharmacokinetic data from study GS-US-177-0105
Maltese: Tabella 6: Sommarju tat-tagħrif farmakokinetiku mill-istudju GS-US-177-0105
English: Microcrystalline cellulose Hydroxypropylcellulose Sodium laurilsulfate Croscarmellose sodium Ferric oxide red (E172) Magnesium stearat Sodium stearyl fumarate
Maltese: Microcrystalline cellulose Hydroxypropylcellulose Sodium laurilsulfate Croscarmellose sodium Ferric oxide red (E172) Magnesium stearate Sodium stearyl fumarate
English: Film coating: poly(vinyl alcohol), macrogol 3350, titanum dioxide (E171), talc, ferric oxide red (E172), ferric oxide yellow (E172).
Maltese: Il-kisi tar-rita: poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, ferric oxide red (E172), ferric oxide yellow (E172).
English: Resistance analysis by week 144
Maltese: Analiżi tar-reżistenza sa ġimgħa 144
English: Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Maltese: - Efavirenz huwa impeditur non-nucleoside reverse transcriptase (NNRTI) - Emtricitabine huwa impeditur nucleoside reverse transcriptase (NRTI) - Tenofovir huwa impeditur nucleotide reverse transcriptase (NtRTI)
English: Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP isozymes
Maltese: Phenytoin, Phenobarbital, u antikonvulsivi oħra li huma sottostrati ta' isoenzimi CYP
English: Efavirenz resistance K103N
Maltese: Reżistenza għal efavirenz K103N
English: Stevens-Johnson syndrome,
Maltese: Sindrome ta' StevensJohnson, eritema multiforme
English: Hepatitis C antivirals Elbasvir/Grazoprevir + Efavirenz
Maltese: Antivirali ta' Epatite Ċ Elbasvir/Grazoprevir + Efavirenz
English: Medicines used to treat convulsions/seizures (anticonvulsants): Carbamazepine, phenytoin, phenobarbital.
Maltese: - Mediċini użati biex jittrattaw aċċessjonijiet (antikonvulsanti): Carbamazepine, phenytoin, phenobarbital.
English: Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1).
Maltese: Mutazzjonijiet assoċjati ma' analogi ta' thymidine kienu jinkludu D67N (n=1) u K70R (n=1).
English: A risk to the infants cannot be excluded.
Maltese: Irriskju gћat-trabi ma jistax jiġi eskluż.
English: OPIOIDS
Maltese: OPIJOIDS
English: Other efavirenz resistance mutations included A98G (n=1), K103E (n=1), V179D (n=1), and M230L (n=1).
Maltese: Mutazzjonijiet oħra tar-reżistenza għal efavirenz kienu jinkludu A98G (n=1), K103E (n=1), V179D (n=1), u M230L (n=1).
English: In uninfected volunteers, multiple doses of 200 to 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 to 42% lower) and a shorter terminal half-life of 40 to 55 hours (single dose half-life 52 to 76 hours).
Maltese: F'voluntiera mhux infettati, dożi multipli ta' 200 sa 400 mg kuljum għal 10 t'ijiem irriżultaw f'firxa ta' akkumulazzjoni inqas milli mistenni (22 sa 42% inqas) u half-life terminali inqas ta' 40 sa 55 siegħa (half-life ta' doża waħda ta' 52 sa 76 siegħa).
English: GMR (%) (90%CI)
Maltese: (90% CI)
English: Ginkgo biloba extracts (herbal preparation).
Maltese: - Estratti ta' ginkgo biloba (preparazzjoni ta' ħxejjex)
English: Cmax: ↑ 38% (competitive inhibition of oxidative metabolism)
Maltese: ↑ 38% (inibizzjoni kompetittiva ta' metaboliżmu ossidattiv)
English: -3.3 (-8.3% to 2.7%)
Maltese: -3.3% (-8.3% sa 2.7%)
English: Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Maltese: Efavirenz jimpedixxi b'mod mhux kompetittiv HIV-1 reverse transcriptase (RT) u ma jimpedixxix b'mod sinifikanti human immunodeficiency virus-2 (HIV-2) RT jew cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, u δ).
English: Hepatobiliary disorders: Common elevated aspartate aminotransferase (AST), elevated alanine Aminotransferase (ALT), elevated gammaglutamyltransferase (GGT)
Maltese: Komuni aspartate aminotransferase (AST) għolja, alanine aminotransferase (ALT) għolja, gammaglutamyltransferase (GGT) għolja
English: patients with HIV-1 RNA < 200 copies/ml
Maltese: pazjenti b'HIV-1 RNA < 200 kopja/ml
English: Cmax: ↔ 11% (CYP3A induction - effect on boceprevir) *0-8 hours
Maltese: Cmax: ↔ 11% (Induzzjoni ta' CYP3A induction - effett fuq boceprevir) *0-8 sigħat
English: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, sodium laurilsulfate, croscarmellose sodium, ferric oxide red (E172), magnesium stearat, sodium stearyl fumarate.
Maltese: Il-qalba tal-pillola: microcrystalline cellulose, hydroxypropylcellulose, sodium laurilsulfate, croscarmellose sodium, ferric oxide red (E172), magnesium stearat, sodium stearyl fumarate.
English: Pack sizes: 30 film coated tablets (1x30) and 90 film-coated tablets (3x30).
Maltese: Daqsijiet tal-pakkett: 30 pillola miksija b'rita (1x30) u 90 pillola miksija b'rita (3x30).
English: The degree of renal impairment was defined according to baseline creatinine clearance (normal renal function when creatinine clearance > 80 ml/min; mild impairment with creatinine clearance=50 to 79 ml/min; moderate impairment with creatinine clearance=30 to 49 ml/min and severe impairment with creatinine clearance=10 to 29 ml/min).
Maltese: Il-grad ta' indeboliment renali ġie definit skont l-eliminazzjoni ta' kreatinina tal-linja bażi (funzjoni renali normali meta l-eliminazzjoni tal-kreatinina > 80 ml/min; indeboliment ħafif b'eliminazzjoni tal-kreatinina=50 sa 79 ml/min; indeboliment moderat b'eliminazzjoni tal-kreatinina =30 sa 49 ml/min u indeboliment sever b'eliminazzjoni tal-kreatinina =10 sa 29 ml/min).
English: The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the efavirenz + emtricitabine + tenofovir disoproxil group and in 10/29 (34.5%) isolates analysed from the efavirenz + lamivudine/zidovudine group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine + tenofovir disoproxil group to the lamivudine/zidovudine group among all subjects).
Maltese: Il-mutazzjoni M184V/I żviluppat fi 2/19 (10.5%) iżolati analizzati minn pazjenti fil-grupp ta' efavirenz + emtricitabine + tenofovir disoproxil u f'10/29 (34.5%) iżolati analizzati fil-grupp ta' efavirenz + lamivudine/zidovudine (valur p ta' < 0.05, it-Test Eżatt ta' Fisher li qabbel il-grupp ta' emtricitabine + tenofovir disoproxil mal-grupp ta' lamivudine/zidovudine fost il-pazjenti kollha).
English: See section 4.8 Description of selected adverse reactions for more details.
Maltese: Ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula għal aktar dettalji.
English: Cmax: ↑ 50% (↑ 20 to ↑ 80) (CYP2B6 induction)
Maltese: Cmax: ↑ 50% (↑ 20 għal ↑ 80) (induzzjoni ta' CYP2B6)
English: In the prior-NNRTI stratum, response rates were 98.9% vs 97.4% for efavirenz/emtricitabine/tenofovir disoproxil and SBR patients respectively; a difference (95%CI) of 1.4% (-4.0%, 6.9%)].
Maltese: Fl-istratum ta' qabel NNRTI, ir-rati tar-rispons kienu 98.9% vs 97.4% għal efavirenz/emtricitabine/tenofovir disoproxil u għal pazjenti SBR rispettivament; differenza (95%CI) ta' 1.4% (-4.0%, 6.9%).
English: Medicines used to treat infection with the hepatitis C virus: boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
Maltese: - Mediċini użati biex jittrattatw l-infezzjoni tal-epatite Ċ: boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, Table 1).
Maltese: Esponimenti ta' raltegravir (sottostrat ta' UGT1A1) jonqsu fil-preżenza ta' efavirenz (ara sezzjoni 4.5, Tabella 1).
English: Cmax: ↑ 25% (↑ 8 to ↑ 45) Cmin: ↔
Maltese: Cmax: ↑ 25% (↑ 8 għal ↑ 45) Cmin: ↔
English: Cmax: ↓ 19% (↓ 40 to ↑ 10)
Maltese: Cmax: ↓ 19% (↓ 40 għal ↑ 10)
English: * p-value < 0.05, Fisher's Exact test comparing efavirenz + emtricitabine + tenofovir disoproxil group to efavirenz + lamivudine/zidovudine group among all patients.
Maltese: * valur p < 0.05, Test Eżatt ta' Fisher li qabbel il-grupp ta' efavirenz + emtricitabine + tenofovir disoproxil mal-grupp ta' efavirenz + lamivudine/zidovudine fost il-pazjenti kollha.
English: Artemether/Lumefantrine/Emtricita bine
Maltese: Artemether/Lumefantrine/Emtricitab ine
English: AUC: ↔*/** (↓ 10% to ↑ 26%) Cmax: ↔*/** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/** (↓ 16 to ↑ 49) (CYP3A4 induction).
Maltese: AUC: ↔*/** (↓ 10% għal ↑ 26%) Cmax: ↔*/** (↓ 5% għal ↑ 26%) Cmin: ↑ 12%*/** (↓ 16 għal ↑ 49) (Induzzjoni ta' CYP3A4).
English: Only a limited number of patients were co-infected with HBV (n = 13) or HCV (n = 26) in study GS01-934.
Maltese: Numru limitat biss ta' pazjenti kienu ko-infettati b'HBV (n=13) jew b'HCV (n=26) fl-istudju GS-01-934.
English: Cmax: ↓ 23% (↓ 30 to ↑ 16)
Maltese: Cmax: ↓ 23% (↓ 30 għal ↑ 16)
English: AUC: ↓ 17% Cmax: ↔ (CYP3A4 induction)
Maltese: AUC: ↓ 17% Cmax: ↔ (induzzjoni CYP3A4)
English: Cmax: ↑ 64% (mechanism of interaction unknown)
Maltese: Cmax: ↑ 64% (mekkaniżmu tal-interazzjoni mhux magħruf)
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil in clinical practice (see section 4.8).
Maltese: Insuffiċjenza renali, indeboliment renali, livell għoli ta' kreatinina, ipofosfatimja u tubulopatija prossimali (inkluż is-sindromu ta' Fanconi) ġew irrapportati bl-użu ta' tenofovir disoproxil fil-prattika klinika (ara sezzjoni 4.8).
English: The mean (%CV) tenofovir exposure increased from 2,185 ng•h/ml (12%) in patients with normal renal function, to 3,064 ng•h/ml (30%), 6,009 ng•h/ml (42%) and 15,985 ng•h/ml (45%) in patients with mild, moderate and severe renal impairment, respectively.
Maltese: L-esponiment medju (%CV) ta' tenofovir żdied minn 2,185 ng•h/ml (12%) f'pazjenti b'funzjoni renali normali, għal 3,064 ng•h/ml (30%), 6,009 ng•h/ml (42%) u 15,985 ng•h/ml (45%) f'pazjenti b'indeboliment renali, ħafif, moderat u sever, rispettivament.
English: Ethinyloestradiol+Norgestimate/Ef avirenz (0.035 mg+0.25 mg q.d./600 mg q.d.)
Maltese: Ethinyloestradiol+Norgestimate/ Efavirenz (0.035 mg+0.25 mg q.d./ 600 mg q.d.)
English: The mean (%CV) emtricitabine exposure increased from 12 µg•h/ml (25%) in subjects with normal renal function to 20 µg•h/ml (6%), 25 µg•h/ml (23%) and 34 µg•h/ml (6%) in patients with mild, moderate and severe renal impairment, respectively.
Maltese: L-esponiment medju (%CV) ta' emtricitabine żdied minn 12 µg•h/ml (25%) f'suġġetti b'funzjoni renali normali għal 20 µg•h/ml (6%), 25 µg•h/ml (23%) u 34 µg•h/ml (6%) f'pazjenti b'indeboliment renali, ħafif, moderat u sever, rispettivament.
English: Treatment group Efavirenz/emtricitabine/tenofovir disoproxil (N=203) n/N (%)
Maltese: Efavirenz/Emtricita bine/Tenofovir disoproxil (N=203) n/N (%)
English: The apparent clearance of tenofovir averaged approximately 307 ml/min.
Maltese: It-tneħħija apparenti ta' tenofovir kellha medja ta' bejn wieħed u ieħor 307 ml/min.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka should be avoided in patients with HIV-1 harbouring the K65R, M184V/I or K103N mutation (see sections 4.1 and 5.1).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka għandu jiġi evitat f'pazjenti b'HIV-1 li jkun qed jaħbi mutazzjonijiet K65R, M184V/I jew K103N (ara sezzjoni 4.1 u 5.1).
English: Cross resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Maltese: Profili ta' kross-reżistenza għal efavirenz, nevirapine u delavirdine in vitro urew li s-sostituzzjoni K103N tagħti nuqqas ta' suxxettibbiltà għat-tliet NNRTIs kollha.
English: The most frequently reported adverse reactions considered possibly or probably related to efavirenz/emtricitabine/tenofovir disoproxil among patients treated up to 48 weeks in study AI266073 were psychiatric disorders (16%), nervous system disorders (13%), and gastrointestinal disorders (7%).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' efavirenz/emtricitabine/tenofovir disoproxil fost pazjenti li kienu ttrattati għal sa 48 ġimgħa fi studju AI266073 kienu disturbi psikjatriċi (16%), disturbi fis-sistema nervuża (13%), u disturbi gastrointestinali (7%).
English: Skin and subcutaneous tissue disorders: Very common rash (moderate-severe, 11.6%, all grades, 18%)
Maltese: Komuni ħafna raxx (moderat-sever, 11.6%, il-gradi kollha,
English: A similar trend was observed in a sub-group analysis of treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml from a retrospective cohort study (data collected over 20 months, see Table 5).
Maltese: Tendenza simili kienet osservata f'analiżi ta' sottogrupp ta' pazjenti li kienu kkurati fil-passat, b'HIV-1 RNA < 75 kopji/ml fil-linja bażi minn studju retrospettiv dwar koorti (dejta miġbura fuq perjodu ta' 20 xahar, ara t-Tabella 5).
English: , myopathy
Maltese: , mijopatija
English: Uncommon anaemia
Maltese: Mhux komuni anemija
English: LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors Atorvastatin/Efavirenz (10 mg q.d./600 mg q.d.)
Maltese: PRODOTTI MEDIĊINALI LI JBAXXU L-LIPIDI Impedituri HMG Co-A Reductase Atorvastatin/Efavirenz (10 mg q.d./600 mg q.d.)
English: Medicines used to treat malaria: Atovaquone/proguanil or artemether/lumefantrine.
Maltese: Mediċini użati biex jittrattaw il-malarja: Atovaquone/proguanil jew artemether/lumefantrine.
English: Co-administration with herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
Maltese: John's wort (Hypericum perforatum) minħabba r-riskju ta' konċentrazzjonijiet fil-plażma mnaqqsa u tnaqqis fl-effetti kliniċi ta' efavirenz (ara sezzjoni 4.5).
English: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197)
Maltese: AUC: ↑ 98% (↑ 77 għal ↑ 123) Cmax: ↑ 79% (↑ 56 għal ↑ 104) Cmin: ↑ 163% (↑ 137 għal ↑ 197)
English: Patients coinfected with HIV and HBV
Maltese: Pazjenti ko-infettati b'HIV/HBV jew HCV
English: Difference between efavirenz/emtricitabine/tenofovir disoproxil and original treatment regimen (95%CI)
Maltese: Differenza bejn Efavirenz/Emtricitabine/Tenofo vir disoproxil u r-reġim ta' trattament oriġinali (95%CI)
English: Artemether/Lumefantrine/Tenofovi r disoproxil
Maltese: Artemether/Lumefantrine/Tenofovir disoproxil
English: When used in combination with efavirenz and two NRTIs, 533/133 mg lopinavir/ritonavir (soft capsules) twice daily yielded similar lopinavir plasma concentrations as compared to lopinavir/ritonavir (soft capsules) 400/100 mg twice daily without efavirenz (historical data).
Maltese: Meta użati flimkien ma' efavirenz u żewġ NRTIs, 533/133 mg lopinavir/ritonavir (kapsuli rotob) darbtejn kuljum taw konċentrazzjonijiet simili ta' lopinavir filplażma meta mqabbel ma' lopinavir/ritonavir (kapsuli rotob) 400/100 mg darbtejn kuljum mingħajr efavirenz (dejta storika).
English: Sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir Co-administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended (see section 4.4 and Table 1).
Maltese: Sofosbuvir/velpatasvir u sofosbuvir/velpatasvir/voxilaprevir L-għoti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka u sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir mhux rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: Cmin: ↓ 12% (↓ 24 to ↑ 1) (CYP3A4 induction)
Maltese: Cmin: ↓ 12% (↓ 24 għal ↑ 1) (Induzzjoni ta' CYP3A4)
English: Emtricitabine: AUC: ↔ Cmax: ↔ C24h: ↔
Maltese: AUC: ↔ Cmax: ↔ C24h: ↔
English: AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction)
Maltese: AUC: ↑ 11% (↑ 5 għal ↑ 18) Cmax: ↑ 16% (↑ 6 għal ↑ 26) Cmin: ↑ 13% (↑ 1 għal ↑ 26) (Induzzjoni ta' CYP3A4)
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil.
Maltese: Ġew irrapportati żewġ każijiet addizzjonali (1 prospettiv u 1 retrospettiv) inkluż espisodji kosistenti ma' difetti fit-tubu newrali bil-pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz, emtricitabine u tenofovir disoproxil.
English: See section 2 “Efavirenz/Emtricitabine/Tenofovir disoproxil Krka contains sodium”.
Maltese: Ara sezzjoni 2 "Efavirenz/Emtricitabine/Tenofovir disoproxil Krka fih sodium".
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 18 years and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka huwa trattament għall-Virus talImmunodefiċjenza Umana (HIV) fl-adulti minn età ta' 18-il sena u aktar li kienu ġew ittrattati b'mediċini antiretrovirali oħra qabel u kellhom l-infezzjoni tal-HIV-1 tagħhom ikkontrollata għal millanqas tliet xhur.
English: Integrase strand transfer inhibitor Raltegravir/Efavirenz (400 mg single dose/-)
Maltese: Impeditur tat-trasferiment ta' integrase strand Raltegravir/Efavirenz (400 mg doża waħda/-)