FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 July 2015
Maltese: 4 ta' Lulju 2015
English: Thiocolchicoside takes part in the PSUR synchronisation project of the Heads of Medicine Agencies.
Maltese: Thiocolchicoside jieħu parti fil-proġett ta' sinkronizzazzjoni tal-PSUR tal-Kapijiet tal-Aġenziji tal-Mediċina.
English: The MAH(s) should submit the next PSUR by:
Maltese: L-MAH(s) għandu(hom) jissottometti(u) l-PSUR li ġej sa:
English: The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Maltese: L-MAH(s) għandu(hom) jipprovdi(u) fis-sottomissjoni tal-pjan għallġestjoni tar-riskju, protokoll għall-istudju dwar l-użu tal-mediċina sabiex jiġu kkaraterizzati l-prattiki tal-preskrizzjoni għall-prodotti mediċinali matul użu kliniku tipiku fi gruppi rappreżentattivi ta' dawk li jippreskrivu u biex jiġu vvalutati r-raġunijiet ewlenin għallpreskrizzjoni.
English: The MAHs should submit a risk management plan (including outline of DUS and educational materials, see also below) in EU format.
Maltese: L-MAHs għandhom jissottomettu pjan għall-ġestjoni tar-riskju (inkluż deskrizzjoni tad-DUS u l-materjal edukattiv, ara wkoll hawn taħt) fil-format tal-UE.
English: Within 30 days following EC decision
Maltese: Fi żmien 30 jum wara ddeċiżjoni tal-KE
English: National competent authorities of Member State(s) coordinated by reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-awtoritajiet nazzjonali kompetenti tal-Istat(i) Membru(i) ikkoordinat(i) mill-Istat(i) Membru(i) ta' referenza jekk applikabbli, għandu/għandhom jiżgura/jiżguraw li l-kondizzjonijiet li ġejjin jiġu sodisfati mill-MAH(s):
English: Conditions to the marketing authorisation
Maltese: Kondizzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq
English: The MAHs should circulate the agreed DHPC in coordination with the NCAs according to the action plan agreed by CHMP.
Maltese: L-MAHs għandhom jiċċirkulaw id-DHPC miftiehma b'koordinazzjoni mal-NCAs skont il-pjan ta' azzjoni miftiehem mas-CHMP.
English: The MAHs should provide within the risk management plan educational material for prescribers and patients.
Maltese: L-MAH(s) għandu(hom) jipprovdi(u) fil-pjan għall-ġestjoni tar-riskju materjal edukattiv għal min jippreskrivi u għall-pazjenti.
English: --1 Strains of inactivated swine influenza A virus: Bakum/IDT1769/2003 (H3N2): ≥ 10.53 log2 GMNU* Haselünne/IDT2617/2003 (H1N1): ≥ 10.22 log2 GMNU* Bakum/1832/2000 (H1N2): ≥ 12.34 log2 GMNU* * GMNU - Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Maltese: ≥ 12.34 log2 GMNU GMNU = Geometric mean of neutralizing units indott fil-fenek ta' l-indi wara darbtejn ta' immunizzazzjoni bi 0.5 ml ta' dan il-vaċċin.
English: 8 vials Zero days
Maltese: 8 Fliexken Xejn ġranet
English: Vial (type I glass)
Maltese: 10 dożi (20 ml)
English: Control regimen (n=635)
Maltese: (n=635)
English: ATC code: J05A G03
Maltese: J05A G03
English: 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40
Maltese: 13 sa < 15 15 sa < 20 20 sa < 25 25 sa < 32.5
English: 3 - < 5 years
Maltese: 3 - < 5 snin
English: Non-nucleoside reverse transcriptase inhibitors.
Maltese: Inibituri non-nukleosidi ta' reverse transcriptase.
English: 2003 PC Haarlem The Netherlands
Maltese: 2003 PC Haarlem
English: It contains: lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fiha: lactose monohydrate.
English: C.I., confidence interval.
Maltese: b C.I., intervall ta' kunfidenza.
English: Efavirenz is highly bound (approximately 99.5 - 99.75 %) to human plasma proteins, predominantly albumin.
Maltese: Efavirenz jintrabat ħafna (bejn wieħed u ieħor 99.5 - 99.75 %) mal-proteini tal-plażma umana, speċjalment albumina.
English: Date of latest renewal: 23 April 2014.
Maltese: Data tal-aħħar tiġdid: 23 ta' April 2014.
English: cells/mm 3 (S.E.M.
Maltese: ċelluli /mm3 (S.E.
English: NC = F, noncompleter = failure.
Maltese: a NC = F, mhux komplut = falliment.
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (e.g., cyclosporine, tacrolimus, sirolimus)/Efavirenz
Maltese: Immunosuppressanti metabolizzati minn CYP3A4 (eż., cyclosporine, tacrolimus, sirolimus)/Efavirenz
English: Dose (ml)
Maltese: Doża (ml)
English: Table 2: Interactions between efavirenz and other medicinal products in adults
Maltese: Tabella 2: Interazzjonijiet fl-adulti bejn efavirenz u prodotti mediċinali oħra
English: Frequency is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); or very rare (< 1/10,000).
Maltese: Il-frekwenza hija definita permezz 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); jew rari ħafna (< 1/10,000).
English: Danmark MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com
Maltese: MSD Danmark ApS Tlf: +45 44 82 40 00 dkmail@merck.com
English: Telaprevir (relative to 750 mg q8h):
Maltese: 750 mg q8h):
English: Skin and subcutaneous tissue disorders very common rash (11.6 %)*
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda komuni ħafna raxx (11.6 %)*
English: Film coating: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Yellow iron oxide (E172), Carnauba wax
Maltese: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Yellow iron oxide (E172), Carnauba wax
English: Do not take Stocrin:
Maltese: Tiħux Stocrin:
English: 90 % confidence intervals unless otherwise noted.
Maltese: a intervalli ta' kunfidenza ta' 90% sakemm mhux indikat mod ieħor.
English: uncommon hepatitis acute rare hepatic failure
Maltese: mhux komuni epatite akuta rari insuffiċjenza tal-fwied‡‡*
English: Injection: Depo-medroxyprogesterone acetate (DMPA)/Efavirenz (150 mg IM single dose DMPA)
Maltese: Depomedroxyprogesterone acetate (DMPA)/Efavirenz (150 mg IM doża waħda DMPA)
English: AUC: ↓ 7 % (↓ 23 to ↑ 13) * Cmax: ↑ 23 % (↓ 1 to ↑ 53) * Efavirenz:
Maltese: AUC: ↓ 7% (↓ 23 għal ↑ 13) * Cmax: ↑ 23% (↓ 1 għal ↑ 53) * Efavirenz:
English: Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir, simeprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir.
Maltese: Mediċini użati biex jikkuraw infezzjoni bil-virus tal-epatite Ċ: boceprevir, telaprevir, simeprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir u sofosbuvir/velpatasvir/voxilaprevir.
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1 %.
Maltese: L-inċidenza ta' eritema multiforme jew is sindrome ta' Stevens-Johnson kienet madwar 0.1 %.
English: S.E.M., standard error of the mean.
Maltese: c S.E.M., żball standardizzat tal-medja.
English: 95 % confidence intervals.
Maltese: b intervalli ta' kunfidenza ta' 95%.
English: Cmax: ↔ 11% (CYP3A induction - effect on boceprevir) *0-8 hours
Maltese: Cmax: ↔ 11% (induzzjoni ta' CYP3A - effett fuq boceprevir) *0-8 sigħat
English: Outer carton: 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Kartuna ta' barra: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: AUC: ↔*/** (↓ 10 to ↑ 26) Cmax: ↔*/** (↓ 5 to ↑ 26) Cmin: ↑ 12 %*/** (↓ 16 to ↑ 49) (CYP3A4 induction).
Maltese: AUC: ↔*/** (↓ 10 sa ↑ 26) Cmax: ↔*/** (↓ 5 sa ↑ 26) Cmin: ↑ 12%*/** (↓ 16 sa ↑ 49) (CYP3A4 induction).
English: Adults and children aged 5 years or more
Maltese: Adulti u tfal ta' 5 snin u fuqhom
English: ‡, disturbance in attention (3.6 %), dizziness (8.5 %), headache (5.7 %), somnolence uncommon agitation, amnesia, ataxia, coordination abnormal, convulsions, thinking abnormal, tremor
Maltese: sturdament (8.5 %), uġigħ ta' ras (5.7 %), ngħas mhux komuni aġitazzjoni, amneżija, ataksja, ko-ordinament anormali, konvulżjonijiet, ħsieb anormali, tregħid‡
English: EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Maltese: ZDV, zidovudine; 3TC, lamivudine;
English: < 400 copies/ml (95 % C.I.
Maltese: < 400 kopja/ml (95 % C.I.b)
English: Efavirenz oral solution (30 mg/ml)
Maltese: Efavirenz soluzzjoni orali (30 mg/ml)
English: In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 M (29 %) [mean ± S.D. (% C.V.)], steady state Cmin was 5.6 ± 3.2 M (57 %), and AUC was 184 ± 73 M·h (40 %).
Maltese: F'35 pazjent li kienu qed jirċievu 600 mg ta' efavirenz darba kuljum, Cmax fiss kien 12.9 ± 3.7 µM (29 %) [medja ± S.D. ( % C.V.)], Cmin fiss kien 5.6 ± 3.2 µM (57 %), u AUC kien 184 ± 73 µM·h (40 %).
English: sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate.
Maltese: Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate.
English: AUC: ↑ 34 % (↑ 18 to ↑ 53) Cmax: ↑ 49 % (↑ 32 to ↑ 69) Efavirenz:
Maltese: ↑ 34% (↑ 18 għal ↑ 53) Cmax: ↑ 49% (↑ 32 għal ↑ 69) Efavirenz:
English: The mean CD4 cell counts were increased by 63  34.5 cells/mm
Maltese: L-għadd tal-medja ta' ċelluli CD4 kibret bi 63 ± 34.5 ċelluli /mm3 mil-linja bażi.
English: AUC: ↔* (↓ 9 to ↑ 10) Cmax: ↑ 17 %* (↑ 8 to ↑ 27) Cmin: ↓ 42 %* (↓ 31 to ↓ 51)
Maltese: ↔* (↓ 9 sa ↑ 10) Cmax: ↑ 17%* (↑ 8 sa ↑ 27) Cmin: ↓ 42%* (↓ 31 sa ↓ 51)
English: Nervous system symptoms of moderate-to-severe intensity were experienced by 19 % (severe 2.0 %) of patients compared to 9 % (severe 1 %) of patients receiving control regimens.
Maltese: Sintomi tas-sistema nervuża li kienu minn moderati sa qawwija nħassu minn 19 % (2.0 % qawwija) tal-pazjenti meta mqabbla ma' 9 % (1 % qawwija) mill-pazjenti li kienu qed jirċievu skedi ta' kura ta' kontroll.
English: AUC: ↓ 31 % (↓ 8 to ↓ 47) Cmin: ↓ 40 %
Maltese: AUC : ↓ 31% (↓ 8 għal ↓ 47) Cmin : ↓ 40%
English: Stocrin may make hormonal contraceptives less likely to work.
Maltese: Stocrin jista' jagħmel lill-kontraċettivi ormonali inqas probabbli li jaħdmu.
English: Dose (ml) Children 3 - < 5 years
Maltese: Tfal 3 - < 5 snin
English: Expected: ↓ Voxilaprevir
Maltese: ↓ Voxilaprevir
English: < 50 copies/ml (95 % C.I.
Maltese: < 50 kopja/ml (95 % C.I.b)
English: The AUC and Cmax of a single 240 mg dose of efavirenz oral solution in uninfected adult volunteers was increased by 30 % and 43 % respectively, when given with a high-fat meal, relative to fasted conditions.
Maltese: L-AUC u s-Cmax ta' doża waħda ta' 240 mg ta' efavirenz soluzzjoni orali f'voluntiera mhux infettati żdiedet bi 30 % u 43 % rispettivament, meta mogħti ma' ikla b'livell għoli ta' xaħam, meta mqabbel ma' kondizzjonijiet ta' sawm.
English: Velpatasvir AUC ↓53% Cmax ↓47% Cmin ↓57%
Maltese: AUC ↓53% Cmax ↓47% Cmin ↓57% Expected:
English: Outer carton: STOCRIN 600 mg
Maltese: Kartuna ta' barra STOCRIN 600 mg
English: uncommon affect lability, aggression, confusional state, euphoric mood, hallucination, mania, paranoia, psychosis
Maltese: mhux komuni bidla kontinwa fil-burdata, aggressjoni, stat konfużjonali, burdata ewforika, alluċinazzjoni, manija, paranoja, psikożi‡, attentat ta' suwiċidju, ideat dwar suwiċidju, katatonja*
English: In the study of 57 children, 3.5 % of patients experienced nervous system symptoms of moderate intensity, predominantly dizziness.
Maltese: Fi studju ta' 57 tifel u tifla, 3.5 % tal-pazjenti kellhom sintomi tas-sistema nervuża ta' intensità moderata, l-iktar sturdament.
English: Amylase: in the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10 % of patients treated with efavirenz and 6 % of patients treated with control regimens.
Maltese: Amylase: fis-sottogrupp ta' 1,008 pazjenti fil-prova klinika, ġew osservati żidiet asintomatiċi fil-livelli ta' serum amylase iktar minn 1.5 darbiet il-livell ta' fuq tan-normal f'10% tal-pazjenti kkurati b'efavirenz u f'6% tal-pazjenti f'kuri ta' kontroll.
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 bl-HIV-1 (n = 6), ilfarmakokinetiċi ta' indinavir u efavirenz kienu ġeneralment komparabbli ma' din id-dejta dwar voluntiera mhux infettati.
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2, imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (, ,  or ).
Maltese: Efavirenz huwa impeditur mhux kompetittiv ta' HIV-1 reverse transcriptase (RT) u ma jimpedix b'mod sinifikanti HIV-2 RT jew polymerases (α, β, γ or δ) tad-DNA ċellulari.
English: STOCRIN 600 mg film-coated tablets Dark yellow, capsule-shaped, debossed with “225” on one side.
Maltese: STOCRIN 600 mg pilloli miksija b'rita Safra skura, forma ta' kapsula, imnaqqxa b'“225” fuq naħa waħda.
English: Merck Sharp & Dohme Cyprus Limited Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com
Maltese: Merck Sharp & Dohme Cyprus Limited Τηλ: 80000 673 (+357 22866700)
English: Tablet core: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate, Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate
Maltese: Qalba tal-pillola: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate, Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate Kisja b'rita:
English: AUC: ↓ 4 % (↓ 0 to ↓ 31) Cmax: ↓ 47 % (↓ 9 to ↓ 51) Total active HMG Co-A reductase inhibitors:
Maltese: AUC: ↓ 4% (↓ 0 għal ↓ 31) Cmax: ↓ 47% (↓ 9 għal ↓ 51) Inibituri attivi totali HMG Co-A reductase:
English: Other macrolide antibiotics (e.g., erythromycin)/Efavirenz
Maltese: Antibijotiċi makrolidi oħrajn (e.ż.,erythromycin)/Efavirenz
English: Stocrin oral solution (30 mg/ml)
Maltese: Stocrin soluzzjoni orali (30 mg/ml)
English: Cmin: ↓ 12 % (↓ 24 to ↑ 1) (CYP3A4 induction)
Maltese: Cmin: ↓ 12% (↓ 24 għal ↑ 1) (induzzjoni ta' CYP3A4)
English: The AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28 % (90 % CI: 22 - 33 %) and 79 % (90 % CI:58 - 102 %), respectively, when given with a high fat meal relative to when given under fasted conditions (see section 4.4).
Maltese: L-AUC u s-Cmax ta' doża waħda ta' 600 mg ta' pilloli miksija b'rita ta' efavirenz f'voluntiera mhux infettati żdiedu bi 28 % (90 % CI: 22 - 33 %) u 79 % (90 % CI:58 - 102 %), rispettivament, meta ngħataw ikla b'ħafna xaħam meta mqabbel ma' meta kienu f'kondizzjonijiet ta' sawm (ara sezzjoni
English: AUC: ↓ 58 % (↓ 39 to ↓ 68) Cmax: ↓ 51 % (↓ 32 to ↓ 58) Total active HMG Co-A reductase inhibitors:
Maltese: AUC: ↓ 58% (↓ 39 għal ↓ 68) Cmax: ↓ 51% (↓ 32 għal ↓ 58) Inibituri attivi totali HMG Co-A reductase:
English: Co-administration of STOCRIN with sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended (refer to the Summary of Product Characteristics for sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir for additional information).
Maltese: sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir mhuwiex rakkomandat (irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal sofosbuvir/velpatasvir u sofosbuvir/velpatasvir/voxilaprevir għal informazzjoni addizzjonali).
English: common pruritus uncommon erythema multiforme, Stevens-Johnson syndrome*
Maltese: komuni ħakk mhux komuni eritema multiforme, sindromu ta' Stevens
English: Cmax: ↑ 11 % (↑ 6 to ↑ 16) Cmin: ↔ (CYP3A4 induction)
Maltese: Cmax: ↑ 11% (↑ 6 għal ↑ 16) Cmin: ↔ (induzzjoni ta' CYP3A4)
English: Children and adolescents (3 to 17 years)
Maltese: Tfal u adolexxenti (minn 3 sa 17-il sena)
English: imidazole and triazole antifungal agents, - certain non-sedating antihistamines (terfenadine, astemizole), - cisapride, - flecainide, - certain antimalarials, - methadone.
Maltese: imidazole u aġenti antifungali ta' triazole, - ċerti antistamini mhux sedattivi (terfenadine, astemizole), - cisapride, - flecainide, - ċerti mediċini kontra l-malarja,
English: AUC: ↓ 71% (↓ 67 to ↓ 74) Cmax: ↓ 51% (↓ 46 to ↓ 56) Cmin: ↓ 91% (↓ 88 to ↓ 92) Efavirenz:
Maltese: AUC: ↓ 71% (↓ 67 sa ↓ 74) Cmax: ↓ 51% (↓ 46 sa ↓ 56) Cmin: ↓ 91% (↓ 88 sa ↓ 92) Efavirenz:
English: The free concentration of efavirenz required for 90 to 95 % inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Maltese: Il-konċentrazzjoni ħielsa ta' efavirenz li kien hemm bżonn għall-inibizzjoni ta' bejn id-90 u l-95 % ta' iżolati wild type jew iżolati tal-laboratorju reżistenti għal zidovudine u iżolati kliniċi in vitro kienet minn 0.46 sa 6.8 nM f'razez ta' ċelluli limfoblastojdi, ċelluli periferali mononukleari tad-demm (PBMCs) u kulturi makrofaġi monoċistiċi.
English: Table 3: Efficacy results for study 006
Maltese: Tabella 3: Riżultati tal-effikaċja għall-istudju 006
English: • Each ml of Stocrin oral solution contains 30 mg of the active substance efavirenz.
Maltese: • Kull ml ta' Stocrin soluzzjoni orali fih 30 mg tas-sustanza attiva efavirenz.
English: Excipient with known effect Each film-coated tablet contains 83.2 mg of lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 83.2 mg ta' lactose (bħala monohydrate).
English: - severe disturbances of electrolyte balance e.g. hypokalaemia or hypomagnesaemia.
Maltese: - disturbi severi tal-bilanċ tal-elettroliti eż. ipokalemija jew ipomanjeżemija.
English: AUC: ↑ 21 % (↑ 10 to ↑ 34) Cmax: ↑ 14 % (↑ 4 to ↑ 26) Cmin: ↑ 25 % (↑ 7 to ↑ 46) (inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Maltese: AUC: ↑ 21% (↑ 10 għal ↑ 34) Cmax: ↑ 14% (↑ 4 għal ↑ 26) Cmin: ↑ 25% (↑ 7 għal ↑ 46) b (inibizzjoni ta' metaboliżmu ossidattiv medjat minn CYP) Meta efavirenz ingħata ma' ritonavir 500 mg jew 600 mg darbtejn kuljum, it-taħlita ma kinetx ittollerata sewwa (per eżempju, kien hemm sturdament, dardir, parasteżija u żieda fl-enzimi tal-fwied).
English: Outer carton: STOCRIN 50 mg tablets
Maltese: Kartuna ta' barra STOCRIN 50 mg pilloli
English: STOCRIN 200 mg film-coated tablets
Maltese: STOCRIN 200 mg pilloli
English: Peak efavirenz plasma concentrations of 1.6 - 9.1 M were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Maltese: L-ogħla konċentrazzjonijiet ta' efavirenz fil-plażma ta' 1.6 - 9.1 µM intlaħqu 5 sigħat wara dożi orali waħedhom ta' 100 mg sa 1,600 mg mogħti lil voluntiera mhux infettati.
English: With efavirenz, an increase of the lopinavir/ritonavir soft capsule or oral solution doses by 33 % should be considered (4 capsules/~6.5 ml twice daily instead of 3 capsules/5 ml twice daily).
Maltese: Ma' efavirenz, għandha tiġi kkunsidrata żieda ta' 33% fid-dożi ta' lopinavir/ritonavir kapsula ratba jew soluzzjoni orali (4 kapsuli/~6.5 ml darbtejn kuljum minflok 3 kapsuli/5 ml darbtejn kuljum).
English: AUC: ↓ 43 % (↓ 34 to ↓ 50) Cmax: ↓ 12 % (↓ 1 to ↓ 26) 2-hydroxy atorvastatin:
Maltese: AUC: ↓ 43% (↓ 34 għal ↓ 50) Cmax: ↓ 12% (↓ 1 għal ↓ 26) 2-hydroxy atorvastatin:
English: Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV RNA < 400 copies/ml, HIV RNA < 50 copies/ml and in terms of mean change from baseline CD4 cell count.
Maltese: Riżultati fit-tul mal-168 ġimgħa tal-istudju 006 (160 pazjent spiċċaw l-istudju bil-kura b'EFV +IDV, 196 pazjent b'EFV + ZDV + 3TC u 127 pazjent b'IDV + ZDV + 3TC, rispettivament), jissuġġerixxu li r-rispons ma' jisfaxxax fix-xejn, fis-sens tal-proporzjoni ta' pazenti b'HIV RNA < 400 kopji/ml, HIV RNA < 50 kopji/ml u fis-sens tal-bidla medja mil-linja bażi CD4 tal-għadd taċ-ċelluli.
English: Outer carton: STOCRIN 30 mg/ml
Maltese: Kartuna ta' barra STOCRIN 30 mg/ml
English: • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
Maltese: • Il-kisja tar-rita fiha: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide isfar (E172), u xema' tal-carnauba.
English: • Separate the syringe from the adapter.
Maltese: • Issepara s-siringa mill-adapter.
English: Diarrhoea occurred in six of nineteen (32 %) children, aged 3 - 8 years, who took efavirenz oral solution in combination with nelfinavir (20 - 30 mg/kg given three times a day) and one or more NRTIs.
Maltese: (32 %), mill-età ta' 3-8 snin, li ħadu soluzzjoni orali ta' efavirenz ikkombinat ma' nelfinavir (20 -30 mg/kg mogħti tliet darbiet kuljum) u NRTI wieħed jew aktar.
English: AUC: ↓ 40 % (↓ 26 to ↓ 57) Cmax: ↓ 18 % (↓ 59 to ↑ 12)
Maltese: AUC: ↓ 40% (↓ 26 għal ↓ 57) Cmax: ↓ 18% (↓ 59 għal ↑ 12)
English: Stocrin may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Maltese: Stocrin jista' jinteraġġixxi ma' mediċini oħrajn, inklużi rimedji preparazzjonijiet bħall-estratti ta' Ginkgo biloba.
English: Study 020 24 weeks
Maltese: Studju 020 kellu
English: (active metabolite):
Maltese: (induzzjoni tal-metaboliżmu)
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV) infection by reducing the amount of the virus in blood.
Maltese: Hija mediċina antiretrovirali li tissielet infezzjoni bil-virus tal-immunodefiċjenza umana (HIV) billi tnaqqas l-ammont ta' virus fid-demm.
English: Stocrin 30 mg/ml oral solution efavirenz
Maltese: STOCRIN 30 mg/ml soluzzjoni orali efavirenz
English: Refer to the prescribing information for glecaprevir/pibrentasvir for more information.
Maltese: Irreferi għallinformazzjoni tal-preskrizzjoni għal glecaprevir/pibrentasvir għal aktar informazzjoni.
English: STOCRIN 50 mg film-coated tablets Yellow, round, debossed with “113” on one side.
Maltese: STOCRIN 50 mg pilloli miksija b'rita Safra, tonda, imnaqqxa b'“113” fuq naħa waħda.
English: No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/l) when indinavir was given alone at 800 mg q8h.
Maltese: Il-Cmin ġeometrika medja għal indinavir (0.33 mg/l) meta ngħata ma' ritonavir u efavirenz kienet ogħla mill-Cmin storika medja (0.15 mg/l) meta indinavir ingħata waħdu f'doża ta' 800 mg q8h.
English: Excipient with known effect 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: 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 li joktor irriskju ta' konċentrazzjonijiet imnaqqsa fil-plażma u ta' effetti kliniċi mnaqqsa ta' efavirenz (ara sezzjoni 4.5).
English: AUC: ↓ 26 % (↓ 15 to ↓ 36) Cmax: ↓ 20 % (↓ 11 to ↓ 28) Cmin: ↓ 32 % (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
Maltese: AUC: ↓ 26% (↓ 15 għal ↓ 36) Cmax: ↓ 20% (↓ 11 għal ↓ 28) Cmin: ↓ 32% (↓ 15 għal ↓ 46) (induzzjoni ta' CYP3A4 u ta' CYP2B6)
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine, and tenofovir disoproxil.
Maltese: Ma sarux studji speċifiċi talinterazzjoni b'efavirenz u NRTIs oħra apparti minn lamivudine, zidovudine, u tenofovir disoproxil.