FrancophonIA/ELRC3.0 huggingface dataset:
English: Indinavir Cmin: ↑ 118 % (Relative to Indinavir 800 mg TID alone)
Maltese: Cmin Indinavir: ↓ 81% (Għal Indinavir 800 mg TID waħdu)
English: If rifabutin treatment is required, alternative agents for treating HIV infection should be sought.
Maltese: Jekk ikun meħtieġ trattament b'rifabutin, wieħed għandu jfittex sustanzi alternattivi għat trattament ta' infezzjoni ta' l-HIV.
English: It should be noted that the decrease in suppression of viral RNA levels was seen more frequently when therapy with indinavir was initiated at doses lower than the recommended oral dose of 2.4 g/day.
Maltese: Għandu jiġi nnutat li t-tnaqqis fis-soppressjoni tal-livelli virali ta' l-RNA iktar ġew osservati meta lkura b'indinavir inbdiet b'dożi iżgħar mid-doża orali rakkomandata ta' 2.4 g/jum.
English: CRIXIVAN is not a cure for HIV.
Maltese: CRIXIVAN mhuwiex kura għall-HIV.
English: Coadministration of CRIXIVAN with vardenafil is likely to result in an increase of vardenafil by competitive inhibition of metabolism.
Maltese: vardenafil b'inibizzjoni kompetittiva tal-metaboliżmu.
English: • quetiapine - used for some mental illnesses such as schizophrenia, bipolar disorder and major depressive disorder
Maltese: • quetiapine - użat għal xi mard mentali bħall-iskizofrenja, disturb bipolari u disturb ta'
English: Patients with mild-to-moderate hepatic insufficiency due to cirrhosis will require a dose reduction of indinavir due to decreased metabolism of indinavir (see section 4.2).
Maltese: Pazjenti li għandhom mard minn moderat sa qawwi fil-fwied minħabba ċirrożi jkollhom bżonn ta' tnaqqis fid-doża ta' indinavir minħabba l-metaboliżmu mnaqqas ta' indinavir (ara sezzjoni 4.2).
English: Currently available data in children above the age of 4 years are described in sections 4.8, 5.1, and 5.2.
Maltese: Id-dejta disponibbli bħalissa fi tfal li għandhom 'il fuq minn 4 snin hija deskritta f'sezzjonijiet 4.8, 5.1 u 5
English: EU/1/96/024/001 180 hard capsules EU/1/96/024/002 270 hard capsules EU/1/96/024/003 360 hard capsules
Maltese: EU/1/96/024/003 360 kapsuli iebsin
English: Nervous system disorders
Maltese: dipressjoni maġġuri
English: HMG-CoA REDUCTASE INHIBITORS Lovastatin, simvastatin
Maltese: Il-kombinazzjoni hija kontra-indikata minħabba żieda fir-riskju ta' mijopatija inkluż rabdomijoliżi
English: Two clinical trials in 41 paediatric patients (4 to 15 years of age) were designed to characterise the safety, antiretroviral activity, and pharmacokinetics of indinavir in combination with stavudine and lamivudine.
Maltese: Żewġ provi kliniċi f'41 pazjent li huma tfal (minn 4 sa 15-il sena) nbnew biex joħorġu l-karatteristiċi ta' sigurta`, attivita` antiretrovirali u l-karatteristiċi farmakokinetiċi ta' indinavir flimkien ma' stavudine u lamivudine.
English: It belongs to a group of medicines called ‘protease inhibitors'.
Maltese: Huwa jagħmel parti minn grupp ta' mediċini msejħa ‘inibituri tal-protease'.
English: In another study, at week 16, the proportion of patients with plasma viral RNA below 400 copies/mL was 59 %; the mean increase in CD4 cell counts was 73 cells/mm
Maltese: HIV RNA <400 kopja/mL u 74% kellhom tagħbija virali <50 kopja/mL.
English: headache, dizziness insomnia, hypoaesthesia; paraesthesia oral paraesthesia.
Maltese: uġigħ ta' ras, sturdament insomnja, ipoestesija; parestesija parestesija orali.
English: • severe pain, tenderness or weakness in your muscles - this is more likely to happen if you are taking cholesterol-lowering medicines called ‘statins' (such as simvastatin).
Maltese: • uġigħ qawwi, sensittività jew dgħufija fil-muskoli tiegħek - dawn għandhom aktar mnejn jiġru jekk inti qed tieħu mediċini li jbaxxu l-kolesterol imsejħa ‘statins' (bħal simvastatin).
English: There are no clinically significant differences in the pharmacokinetics of indinavir in HIV seropositive women compared to HIV seropositive men.
Maltese: M'hemmx differenzi b'sinifikanza klinika fil-karatteristiċi farmakokinetiċi ta' indinavir f'nisa bl-HIV seropożittivi meta mqabbla ma' rġiel bl-HIV seropożittivi.
English: Indinavir AUC: ↔ (Relative to Indinavir 800 mg TID historical controls)
Maltese: AUC Indinavir: ↔ (Għal kontrolli storiċi Indinavir
English: Similarly, in antiretroviral naive patients, indinavir with and without zidovudine compared with zidovudine alone reduced the probability of ADID at 48 weeks from 15 % with zidovudine alone to approximately 6 % with indinavir alone or in combination with zidovudine.
Maltese: Bl-istess mod, f'pazjenti li qabel ma kinux qed jieħdu kura antiretrovirali, indinavir waħdu jew ma' zidovudine meta mqabbel ma' zidovudine waħdu naqqas il-probabbilta` ta' ADID fit-48 ġimgħa minn 15 % b'zidovudine biss għal bejn wieħed u ieħor 6 % b'indinavir biss jew flimkien ma' zidovudine.
English: Crixivan, 800 mg every 8 hours + zidovudine 200 mg every 8 hours and lamivudine 150 mg twice a day).
Maltese: Waqt it-tqala, ġie dimostrat li espożizzjoni sistemika għal indinavir jitnaqqas b'mod rilevanti (PACTG 358. Crixivan, 800 mg kull 8 sigħat + zidovudine 200 mg kull 8 sigħat u lamivudine 150 mg darbtejn kuljum).
English: Cases of interstitial nephritis with medullary calcification and cortical atrophy have been observed in patients with asymptomatic severe leucocyturia (> 100 cells/high power field).
Maltese: F'pazjenti b'lewkosajturja qawwija asintomatika (>100 ċelluli/high power field) ġew osservati każijiet ta' nefrajtis interstizjali b'kalċifikazzjoni tal-mudullun u atrofija tal-kortiċi.
English: Careful monitoring of therapeutic and adverse effects is recommended when tacrolimus is concomitantly administered with indinavir/ritonavir.
Maltese: Huwa rrakkomandat monitoraġġ attent ta' l-effetti terapewtiċi u avversi meta tacrolimus jingħata fl-istess ħin ma' indinavir/ritonavir.
English: Analysis of plasma and urine samples from subjects who received indinavir indicated that indinavir metabolites had little proteinase inhibitory activity.
Maltese: L-analiżi ta' kampjuni tal-plażma u l-urina minn suġġetti li ngħataw indinavir indikat li l-metaboliti ta' indinavir ftit kellhom attivita` inibitorja fuq proteinase.
English: Ritonavir increases the serum levels of amprenavir as a result of CYP3A4 inhibition.
Maltese: Ritonavir iżid il-livelli tas-serum ta' amprenavir bħala konsegwenza ta' l-inibizzjoni ta' CYP3A4.
English: Saquinavir 600 mg SD (hard gel capsule formulation) (Indinavir 800 mg TID)
Maltese: Saquinavir 600 mg SD (formulazzjoni ta' kapsula b'ġell iebes)
English: Capsule shell: gelatin titanium dioxide (E 171)
Maltese: • Il-kapsuli huma stampati b'linka tal-istampar li fiha titanium dioxide (E 171), indigo carmine
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV b'immunodefiċjenza qawwija fil-mument meta tinbeda t-terapija antiretrovirali mħallta (CART), jista' jkun hemm reazzjoni infjammatorja għal infezzjonijiet opportunistiċi mingħajr sintomi jew residwali.
English: Anti-Mycobacterial Isoniazid 300 mg QD (Indinavir 800 mg TID)
Maltese: Isoniazid 300 mg QD (Indinavir 800 mg TID)
English: Indinavir binds reversibly to the protease active site and inhibits competitively the enzyme, thereby preventing cleavage of the viral precursor polyproteins that occurs during maturation of the newly formed viral particle.
Maltese: Indinavir jintrabat b'mod reversibbli mas-sit attiv tal-protease u jinibixxi b'mod kompetittiv l-enzima, u b'hekk iwaqqaf milli l-poliproteini prekursuri virali jinqasmu li sseħħ waqt il-maturazzjoni tal-partiċella virali li għadha kemm ġiet iffurmata.
English: nausea, vomiting, diarrhoea, dyspepsia flatulence, dry mouth, acid regurgitation hepatitis, including reports of hepatic failure, pancreatitis.
Maltese: tqalligħ, rimettar, dijarea, dispepsja gass, ħalq xott, rigurġitazzjoni tal-aċidu epatite, inkluż rapporti ta' insuffiċjenza epatika,
English: Adverse reactions, including nephrolithiasis, may lead to treatment interruption.
Maltese: Reazzjonijiet avversi, inkluż nefrolitjasi, jistgħu jwasslu għallwaqfien tal-kura.
English: Clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to CRIXIVAN in  5 % of patients treated with CRIXIVAN monotherapy or in combination with NRTI(s) (n = 309) for 24 weeks are listed below.
Maltese: L-investigaturi rrapurtaw reazzjonijiet kliniċi avversi li hemm possibilita`, probabbilita` jew ċertezza li huma marbuta ma' CRIXIVAN f'≥ 5 % tal-pazjenti li ġew ikkurati bi CRIXIVAN biss jew flimkien ma' NRTI(s) (n = 309) għal 24 ġimgħa, u li jinġiebu hawn taħt.
English: Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ritonavir.
Maltese: Huwa rrakkomandat monitoraġġ attent ta' l-effetti terapewtiċi u avversi meta atovaquone jingħata fl-istess ħin ma' indinavir/ritonavir.
English: Anti-Mycobacterial Rifabutin
Maltese: Anti-Mijkobatterjali
English: Treatment with indinavir alone or in combination with other antiretroviral agents (i.e., nucleoside analogues) has so far been documented to reduce viral load and increase CD4 lymphocytes in patients with CD4 cell counts below 500 cells/mm
Maltese: Il-kura b'indinavir biss jew flimkien ma' aġenti antiretrovirali oħra (bħall-analogi nukleosidi) s'issa ġew dokumentati li jnaqqsu l-ammont ta' virus u jkattru l-limfoċiti CD4 f'pazjenti li kellhom l-għadd ta' ċelluli CD4 taħt il-500 ċellula/ mm
English: Careful monitoring of serum levels or therapeutic effects is recommended when these medicines are concomitantly administered with indinavir/ritonavir.
Maltese: Huwa rrakkomandat monitoraġġ b'attenzjoni tal livelli ta' serum jew ta' l-effetti terapewtiċi meta dawn ilmediċini jingħataw fl-istess ħin ma' indinavir/ritonavir.
English: Coadministration of CRIXIVAN with sildenafil is likely to result in an increase of sildenafil by competitive inhibition of metabolism.
Maltese: L-għoti fl-istess ħin ta' CRIXIVAN u sildenafil x'aktarx li jirriżulta f'żieda ta' sildenafil b'inibizzjoni kompetittiva tal metaboliżmu.
English: • do not take CRIXIVAN with food that is high in calories, fat and protein.
Maltese: • ma tiħux CRIXIVAN ma' ikel b'ħafna kaloriji, xaħam u proteini.
English: The use of rifampicin with indinavir is contraindicated.
Maltese: ritonavir għal kontraindikazzjonijiet addizzjonali.
English: CRIXIVAN 400 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil seal containing 90 or 180 capsules.
Maltese: Il-kapsuli ibsin ta' CRIXIVAN 400 mg jiġu fi fliexken HDPE li jkun fihom 90 jew 180 kapsula u li jkunu b'tapp ta' polypropylene u siġill tal-fojl.
English: Interaction with indinavir/ritonavir Not studied, combined administrations are expected to significantly increase concentrations of midazolam, particularly when midazolam is given orally (CYP3A4 inhibition).
Maltese: L-interazzjoni indinavir/ritonavir ma ġietx studjata, għoti kombinat huwa mistenni li jżid b'mod sinjifikanti lkonċentrazzjonijiet ta' midazolam, b'mod partikolari meta midazolam jingħata mill-ħalq (Inibizzjoni ta' CYP3A4).
English: CRIXIVAN 400 mg hard capsules Indinavir
Maltese: CRIXIVAN 400 mg kapsuli ibsin Indinavir
English: Preliminary clinical data suggest that CRIXIVAN 400 mg in combination with ritonavir 100 mg, both administered orally twice daily, may be an alternative dosing regimen (see section 5.2).
Maltese: 100 mg, it-tnejn li huma mogħtija millħalq darbtejn kuljum, jista' jkun reġimen ta' dosaġġ alternattiv (ara sezzjoni 5.2).
English: CRIXIVAN 200 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil seal containing 180, 270 or 360 capsules.
Maltese: Il-kapsuli ibsin ta' CRIXIVAN 200 mg jiġu fi fliexken HDPE li jkun fihom 180, 270 jew 360 kapsula u li jkunu b'tapp ta' polypropylene u siġill tal-fojl.
English: Data from a steady state study in healthy volunteers indicate that there is a diurnal variation in the pharmacokinetics of indinavir.
Maltese: Tagħrif minn studju fiss f'voluntiera f'saħħithom jindika li hemm varjazzjoni waqt il-ġurnata filkaratterisitiċi farmakokinetiċi ta' indinavir.
English: Interaction with indinavir/ritonavir not studied Ritonavir may modify P-glycoprotein mediated fexofenadine efflux when coadministered resulting in increased concentrations of fexofenadine.
Maltese: Ritonavir jista' jimmodifika efflussi ta' fexofenadine medjati b'P-glycoprotein meta mogħti fl-istess ħin u dan iwassal f'konċentrazzjonijiet miżjuda ta' fexofenadine.
English: Among patients experiencing viral RNA rebound during indinavir monotherapy at 800 mg q8h, substitutions at only three of these sites were observed in the majority of patients: V82 (to A or F), M46 (to I or L), and L10 (to I or R).
Maltese: Fost il-pazjenti li reġa' kellhom qabża fl-RNA virali waqt li kienu qed jiġu kkurati b'indinavir biss b'doża ta' 800 mg q8h, fil-maġġoranza tal-pazjenti ġew osservati sostituzzjonijiet f'żewġ jew tliet siti biss V82 (sa A jew F), M46 (sa I jew L), and L10 (sa I jew R).
English: If CRIXIVAN is coadministered with parenteral midazolam, it should be done in an intensive care unit with close clinical monitoring in case of respiratory depression and/or prolonged sedation.
Maltese: midazolam parenterali, dan għandu jsir f'taqsima ta' kura intensiva b'monitoraġġ kliniku mill-qrib fil-każ ta' depressjoni respiratorja u/jew sedazzjoni mtawwla.
English: Interaction with indinavir/ritonavir not studied Morphine levels may be decreased due to induction of glucuronidation by coadministered ritonavir.
Maltese: Il-livelli tal-morfina jistgħu jitnaqqsu minħabba induzzjoni ta' glukuronidazzjoni minn ritonavir mogħti fl-istess ħin.
English: Based on an interaction study with lopinavir/ritonavir, combination of rosuvastatin and protease inhibitors is not recommended.
Maltese: Abbażi ta' studju ta' interazzjoni b'lopinavir/ritonavir. kombinazzjoni ta' rosuvastatin u inibituri protease mhijiex rakkomandata.
English: Diltiazem AUC0-24hr:  43 % Indinavir/ritonavir AUCs: 
Maltese:  31% Cmin Indinavir:  40% AUC Efavirenz:
English: rash, dry skin pruritus rash including erythema multiforme and Stevens Johnson syndrome, hypersensitivity vasculitis, alopecia, hyperpigmentation, urticaria; ingrown toenails and/or paronychia.
Maltese: Stevens Johnson, vaskulite minn sensittività eċċessiva, alopeċja, iperpigmentazzjoni, urtikarja; dwiefer tas-saqajn li jikbru 'l ġewwa u/jew paronikja.
English: The AUC and peak plasma concentrations were generally similar to those previously observed in HIV-infected adults receiving the recommended dose of 800 mg every 8 hours; it should be observed that the plasma concentrations 8 hours post dose were lower.
Maltese: B'mod ġenerali l-AUC u l-ogħla konċentrazzjonijiet tal-plażma kienu simili għal dawk osservati qabel f'adulti infettati bl-HIV li kienu qed jingħataw id-doża rakkomandata ta' 800 mg kull 8 sigħat; għandu jiġi osservat li lkonċentrazzjonijiet tal-plażma 8 sigħat wara d-doża kienu iktar baxxi.
English: • fexofenadine, loratidine - antihistamines used for hay fever and other allergic conditions
Maltese: • fexofenadine, loratidine - antiistamini li jintużaw għall-hay fever u għal kondizzjonijiet allerġiċi oħrajn
English: HDPE bottles with a polypropylene cap and a foil induction cap containing 90 or 180 capsules.
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali 3 snin għal fliexken HDPE li fihom 90 u 180 kapsula iebsa.
English: Indinavir AUC24hr:220 % Indinavir Cmin:↑ 24-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
Maltese: Cmin Indinavir:↑ 24-il darba (Għal Indinavir 800 mg TID waħdu*)
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Maltese: Fil-każ ta' terapija antivirali għall-epatite B u C li tittieħed fl-istess ħin, jekk jogħġbok irreferi wkoll għall-informazzjoni relevanti dwar dawn il-prodotti mediċinali.
English: Refer also to sections 4.2 and 4.3.
Maltese: Irreferi wkoll għas-sezzjonijiet 4.2 u 4.3.
English: Careful monitoring of therapeutic and adverse effects is recommended when erythromycin or itraconazole are concomitantly administered with indinavir/ritonavir.
Maltese: Erythromycin, Itraconazole L-interazzjoni indinavir/ritonavir ma ġietx studjata.
English: In patients at increased risk, urinary screening should be considered.
Maltese: F'pazjenti b'riskju ikbar, għandu jitqies l-eżami ta' l-urina.
English: Indinavir AUC24hr:68 % Indinavir Cmin: ↑ 10-fold (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC24hr: 
Maltese: AUC Indinavir: ↔ Cmin Indinavir: ↑ 118% (Għal Indinavir 800 mg TID waħdu)
English: Concomitant use of indinavir with lovastatin or simvastatin is not recommended due to an increased risk of myopathy including rhabdomyolysis.
Maltese: Mhux rakkomandat li indinavir jingħata ma' lovastatin u simvastatin billi dan iwassal għal żieda firriskju ta' mijopatija inkluż rabdomijolajsis.
English: • midazolam (by injection) - used for acute fits (seizures) and to send patients to sleep before some medical procedures
Maltese: • midazolam (permezz ta' injezzjoni) - jintuża għal aċċessjonijiet akuti u biex iraqqad ilpazjenti qabel xi proċeduri mediċi
English: The following adverse reactions have been reported during clinical studies in adults and/or postmarketing use for CRIXIVAN monotherapy and/or CRIXIVAN with combination antiretroviral therapy (CART).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapurtati waqt studji kliniċi fl-adulti u/jew l-użu wara t-tqegħid fis-suq ta' CRIXIVAN mogħti waħdu u/jew CRIXIVAN mogħti flimkien ma' terapija antiretrovirali mħallta (CART).
English: Indinavir AUC: ↔
Maltese: AUC Indinavir/ Ritonavir: ↔
English: Indinavir levels may increase on stopping St. John's wort, and the dose of CRIXIVAN may need adjusting.
Maltese: John's wort, u d-doża ta' CRIXIVAN jista' jkollha bżonn ta' aġġustament.
English: HDPE bottle with a polypropylene cap and a foil induction cap containing 180, 270 or 360 capsules.
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT LI JMISS MAL-PRODOTT CRIXIVAN 200 mg - pakketti ta' 180, 270 u 360 kapsula - Tikketta tal-flixkun
English: Six of these 11 (55 %) patients had mean indinavir plasma concentrations 8 hours postdose (Cmin) below assay threshold of reliable quantification.
Maltese: 6 minn dawn il-11 (55 %) -il pazjent kellhom konċentrazzjonijiet medji tal-plażma ta' indinavir 8 sigħat wara d-doża (Cmin) taħt l-għatba ta' l-assay għal kwantifikazzjoni li tista'
English: Concurrent use of indinavir with rifampicin or herbal preparations containing St John's wort (Hypericum perforatum) is contraindicated.
Maltese: Użu fl-istess ħin ta' indinavir ma' rifampicin jew ma' preparazzjonijiet erbali li fihom St John's wort (Hypericum perforatum) huwa kontra-indikat.
English: The risk of you having bone problems is higher if you: - drink alcohol - have a high body mass index - have an immune system that is very weak - have been taking corticosteroids at the same time as CRIXIVAN - take combination antiretroviral therapy for a long time.
Maltese: - għandek indiċi tal-massa tal-ġisem għoli - għandek sistema immuni li hija dgħajfa ħafna - kont qed tieħu kortikosterojdi fl-istess waqt ma' CRIXIVAN - tieħu terapija antiretrovirali kkombinata għal żmien twil.
English: Indinavir AUC: 25 % Indinavir Cmin ↓ 50 % (Relative to Indinavir/ritonavir 800/100 BID alone)
Maltese: AUC Indinavir: ↓ 20% Cmin Indinavir: ↑ 29% (Fir-rigward ta' Indinavir 800
English: Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with indinavir/ritonavir.
Maltese: Huwa rrakkomandat monitoraġġ attent ta' l-effetti terapewtiċi u avversi meta loratidine jingħata fl-istess ħin ma' indinavir/ritonavir.
English: Less than 20 % of indinavir is excreted renally.
Maltese: Inqas minn 20 % ta' indinavir jitneħħa permezz tal-kliewi.
English: Tadalafil dose should not exceed a maximum of 10 mg in a 72 hour period in patients receiving concomitant indinavir therapy.
Maltese: Doża ta' Tadalafil ma għandhiex taqbeż massimu ta' 10 mg f'perjodu ta' 72 siegħa f'pazjenti li jirċievu terapija ta' indinavir fl-istess ħin.
English: Indinavir AUC24hr: 178 % Indinavir Cmin:11-fold; (Relative to Indinavir 800 mg TID alone*) Ritonavir AUC:  72 % Ritonavir Cmin:  62 %
Maltese: AUC Indinavir24hr: 178% Cmin Indinavir:11-il darba;
English: An increase in hepatic weight occurred in rats treated with indinavir at doses  40 mg/kg/day and was accompanied by hepatocellular hypertrophy at doses  320 mg/kg/day.
Maltese: Żieda fil-piż tal-fwied seħħet fil-firien ikkurati b'indinavir b'dożi ≥ 40 mg/kg/jum u ġiet ma' ipertrofija fil-ċelluli tal-fwied b'dożi ≥ 320 mg/kg/jum.
English: Indinavir must not be given with ritonavir to patients with decompensated liver disease as ritonavir is principally metabolized and eliminated by the liver (see section 4.4).
Maltese: Indinavir m'għandux jingħata ma' ritonavir lil pazjenti b'mard tal-fwied dekompensat minħabba li ritonavir huwa metabolizzat prinċipalment u eliminate mill-fwied (ara sezzjoni 4.4).
English: Dose adjustment of warfarin may be required.
Maltese: Jista' jkun meħtieġ aġġustament fiddoża ta' warfarin.
English: The pharmacokinetics of indinavir in these 11 patients at 6 weeks postpartum were generally similar to those observed in non-pregnant patients in another study (see section 4.6).
Maltese: Il-farmakokinetika ta' indinavir f'dawn il-11-il pazjenti fis-6 ġimgħa wara l-ħlas kienu ġeneralment simili għal dawk osservati f'pazjenti mhux tqal f' studju ieħor(ara sezzjoni 4.6).
English:  indinavir plasma concentrations may be expected (CYP3A induction).
Maltese: ↓jistgħu jkunu mistennija konċentrazzjonijiet tal-plażma ta' indinavir (induzzjoni CYP3An).
English: The application was submitted to Germany as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Maltese: Lapplikazzjoni ġiet sottomessa lill-Ġermanja bħala l-Istat Membru ta' Referenza u lill-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, Franza, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, l-Olanda, il-Polonja, il-Portugall, ir-Rumanija, isSlovakkja, is-Slovenja, Spanja u lir-Renju Unit bħala l-Istati Membri kkonċernati.
English: On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place.
Maltese: Fis-27 ta' Settembru 2012, saret laqgħa plenarja tal-Kumitat Permanenti għall-Prodotti Mediċinali Veterinarji.
English: This is a ‘hybrid application' according to Article 13(3) Directive 2001/82/EC, as amended, referring to the reference product, Nuflor Swine 300 mg/ml solution for injection (FR/V/0118/001).
Maltese: Din hija ‘applikazzjoni ibrida' skont l-Artikolu 13(3) tadDirettiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza, Nuflor Swine 300 mg/ml soluzzjoni għal injezzjoni (FR/V/0118/001).
English: Enrofloxacin 5% solution for injection was used for control.
Maltese: Enrofloxacin 5% soluzzjoni għal injezzjoni ntuża bħala kontroll.
English: On 13 June 2012 the CVMP adopted an opinion regarding this referral.
Maltese: Fit-13 ta' Ġunju 2012, is-CVMP adotta opinjoni dwar dan ir-riferiment.
English: The official clinical break point for florfenicol sensitivity is ≤2 µg/ml.
Maltese: Il-valur tal-limitu kliniku uffiċjali għas-sensittività ta' florfenicol huwa ta' ≤2 µg/ml.
English: The design of the field study should follow the design of the field study V-0049-0059 in terms of the inclusion/exclusion criteria and clinical endpoints.
Maltese: Id-disinn tal-istudju filprattika għandu jsegwi d-disinn tal-istudju fuq il-post V-0049-0059 f'termini tal-kriterji ta' inklużjoni/esklużjoni u l-endpoints kliniċi.