FrancophonIA/ELRC3.0 huggingface dataset:
English: Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data have shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Ġew irrappurtati interazzjonijiet ma' prodotti mediċinali oħra, li jistgħu jipperikolaw il-ħajja u oħrajn fatali, f'pazjenti kkurati b'colchicine u ritonavir (inibizzjoni ta' CYP3A u P-gp) f'pazjenti b'indeboliment renali u / jew epatiku (ara sezzjonijiet 4.3 u 4.4).
English: EU/1/16/1092/001 EU/1/16/1092/002 EU/1/16/1092/003 EU/1/16/1092/004 EU/1/16/1092/005 EU/1/16/1092/006 EU/1/16/1092/007 EU/1/16/1092/008 EU/1/16/1092/009 EU/1/16/1092/010 EU/1/16/1092/011 EU/1/16/1092/012 EU/1/16/1092/013
Maltese: EU/1/17/1242/001 EU/1/17/1242/002 EU/1/17/1242/003
English: Heart failure/post-myocardial infarction
Maltese: Mhux komuni Infart mijokardijaku
English: Dantrolene (infusion)
Maltese: • għatx (deidratazzjoni)
English: Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and of the hepatic efflux transporter MRP2.
Maltese: L-effetti ta' ritonavir (waħdu jew flimkien ma' aġenti antietrovirali oħra) fuq werrejja bijoloġiċi talattivita' tal-mard, bħal għadd ta' ċelluli CD4 u RNA virali, ġew evalwati f'diversi studji li kienu jinvolvu pazjenti infettati bl-HIV-1.
English: CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary.
Maltese: Dożi baxxi ta' ritonavir urew effetti profondi fuq il-farmakokinetika ta' impedituri protejaż oħra (u prodotti oħra metabolizzati b'CYP3A4), u impedituri oħra protejaż jistgħu jinfluwenzaw ilfarmakokinetika ta' ritonavir (ara sezzjoni 4.5).
English: Nasopharyngitis
Maltese: Nevirapine
English: Hepatitis
Maltese: Metaboliżmu
English: Exanthema
Maltese: Fexofenadine
English: Hyperuricaemia
Maltese: Carbamazepine
English: Hyperlipidaemia
Maltese: Il-pillola
English: Hepatobiliary disorders
Maltese: Parametri tal-metaboliċi
English: Aortic and mitral valve stenosis
Maltese: Ritonavir Mylan fih is-sodium
English: PVC/PCTFE blisters.
Maltese: Impedituri Phosphodiesterase (PDE5)
English: Mean absolute bioavailability is 23 %.
Maltese: Nelfinavir ↑ 20sa39%
English: Lithium
Maltese: Triazolam
English: Simvastatin
Maltese: Kummissjoni
English: Hyperkalaemia
Maltese: Raltegravir
English: Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Tablet core:
Maltese: Midazolam huwa fil-biċċa l-kbira tiegħu metabolizzat b'CYP3A4.
English: How to take Amlodipine/Valsartan Mylan
Maltese: Mediċini oħra u Ritonavir Mylan
English: Erectile dysfunction
Maltese: Derivattivi tal-Ergotina
English: Pruritus
Maltese: Vorapaxar
English: - Keep this leaflet.
Maltese: F'xi każi ġew osservati mwiet.
English: Amlodipine
Maltese: Rifampicin
English: Erythema multiforme
Maltese: • visjoni mċajpra
English: Immune system disorders
Maltese: Mediċini Immuno-Suppressanti
English: Hypertonia
Maltese: Buspirone
English: Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Fi studju komplet fl-2003, 50 tifel u tifla ta' età ta' bejn 4 ġimgħat u sentejn, li kienu infettati b'HIV-1 u qatt ma kienu esponew ruħom għal impedituri protejaż u lamivudine, kienu qegħdin jirċievu 350 jew 450 mg/m2 ritonavir kull 12 -il siegħa flimkien ma' 160 mg/m2 zidovudine kull 8 siegħat u 4 mg/kg lamivudine kull 12 -il siegħa.
English: Ankle swelling
Maltese: Mard tal-Fwied
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Maltese: Il-frekwenza ta' dan mhux magħrufa (ara sezzjoni 4.4).
English: Pollakiuria
Maltese: Eċċipjenti
English: There was no significant difference in the primary endpoint between amlodipine-based therapy and chlorthalidone-based therapy: risk ratio (RR) 0.98 95 % CI (0.90-1.07) p=0.65.
Maltese: HIV RNA fuq perijodu ta'16 -il ġimgħa kien ta' 0.79 log10 (medja ta' tnaqqis massimu: 1.29 log10) fil-grupp ta' ritonavir kontra -0.01 log10 fil-grupp ta' kontroll.
English: medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, talithromycin); clarithromycin (for infections caused by bacteria); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); tacrolimus (used to control your body's immune response, enabling your body to accept the transplanted organ); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Maltese: - pethidine, piroxicam, propoxyphene (użati biex itaffu l-uġigħ); - cisapride (użat biex itaffi ċerti problemi fl-istonku); - rifabutin (użat biex jippreveni / jikkura ċerti infezzjonijiet)*; - voriconazole (użat biex jikkura infezzjonijiet tal-fungu)*; - simvastatin, lovastatin (użati biex inaqqsu l-kolesterol fid-demm); - alfuzosin (użati biex jikkuraw it-tkabbir tal-glandola tal-prostata); - fusidic acid (użat biex jikkura infezzjonijiet bil-batterji); - sildenafil jekk int tbati minn marda tal-pulmun li tissejjaħ pressjoni għolja fl-arterji pulmonari li tagħmilha diffiċli biex tieħu n-nifs.
English: Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Maltese: • attakk tal-epilessija (aċċessjonijiet)
English: PC:
Maltese: Manifattur:
English: Somnolence
Maltese: Nelfinavir
English: Vertigo
Maltese: Trazodone
English: Hyperglycaemia
Maltese: Theophylline1
English: Gingival hyperplasia
Maltese: Mediċina Sedattiva/ Ipnotika
English: Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets amlodipine/valsartan
Maltese: Ritonavir Mylan 100 mg pilloli miksija b'rita
English: Interactions linked to amlodipine
Maltese: Mediċini għal kontra l-istamina
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 98 film-coated tablets 14x1 film-coated tablets (unit dose) 28x1 film-coated tablets (unit dose) 30x1 film-coated tablets (unit dose) 56x1 film-coated tablets (unit dose) 90x1 film-coated tablets (unit dose) 98x1 film-coated tablets (unit dose)
Maltese: IV 300 q12h, 3 jiem ↑ 86% MD 0.4 doża waħda orali 200 q12h, 13 jiem ↑ 22%  Din l-interazzjoni tista' tkun ikkaġunata mill-modifikazzjoni ta' effluss ta' digoxin medjat b'P- glycoprotein minn ritonavir f'doża bħala aġent antiretrovirali jew biex iżid l-effett farmakokinetiku.
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Maltese: Il-parametri farmakokinetiċi ta' ritonavir ma ġewx studjati f'pazjenti li jbatu minn indeboliment renali.
English: Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets Amlodipine/Valsartan Mylan 10 mg/160 mg tablets are light brown, oval, biconvex film-coated tablet marked with “AV3” on one side and “M” on the other side.
Maltese: Il-kura għandha tinbeda bi 300 mg (3 pilloli) darbtejn kuljum għal perijodu ta' tlett ijiem, u tiżdied b'100 mg (pillola waħda) darbtejn kuljum sakemm wieħed jasal sa 600 mg darbtejn kuljum, u dana fuq perijodu ta' mhux akatr minn 14 il- ġurnata.
English: Hepatic impairment Amlodipine/valsartan is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: L-għoti flimkien ma' lurasidone huwa kontraindikat (ara sezzjoni 4.3).
English: EXP
Maltese: Avanafil
English: Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets Yellow, oval, approximately 15.6 mm × 7.8 mm, biconvex film-coated tablet debossed with “AV2” on one side and “M” on the other side.
Maltese: Bl-intenzjoni li jiġu ttrattati analisi, 50% u 57% tal-pazjenti fil-gruppi dożati 350 and 450 mg/m2 rispettivament, kellhom nuqqas fl-HIV-1 RNA fil-plażma għal ≤ 400 kopji/ml f'Ġimgħa 48.
English: Frequency Amlodipine/Valsartan Amlodipine Valsartan
Maltese: Frekwenza Reazzjoni avversa
English: Dysgeusia
Maltese: Ranolazine
English: Renal and urinary disorders
Maltese: Mhux komuni Indeboliment renali akut
English: Ear and labyrinth disorders
Maltese: Pazjenti b'indeboliment funzjonali renali
English: amlodipine/valsartan mylan 5 mg/80 mg
Maltese: Meta tieħu Ritonavir Mylan mal-ikel u max-xorb
English: Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Clorazepate, diazepam, estazolam, flurazepam, midazolam mittieħed mill-ħalq u parenterali
English: Arthralgia
Maltese: Delamanid
English: aliskiren.
Maltese: ritonavir.
English: Not known Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Maltese: Insuffiċjenza renali, indeboliment renali, krejatinina għolja, ipofosfatimja u tubulopatija prossimali (inkluż is-sindromu ta' Fanconi) kienu rrappurtati bl-użu ta' tenofovir disoproxil fl-użu kliniku (ara sezzjoni 4.8).
English: Pack sizes: 14, 14x1 (unit dose), 28, 28x1 (unit dose), 30x1 (unit dose), 56, 56x1 (unit dose), 90x1 (unit dose), 98 or 98x1 (unit dose) film-coated tablets.
Maltese: L-akkumulazzjoni ta' mutazzjonijiet oħra fil-ġene tal-protejazi (inkluż f'pożizzjonijiet 20, 33, 36, 46, 54, 71, u 90) tista' tikkontribwixxi ukoll għar-resistenza għal ritonavir.
English: Vasculitis
Maltese: Alprazolam
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: Cl/F (L/h)
English: Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets Tablet core:
Maltese: F'dan il-każ, għandu jsir monitoraġġ kliniku mill-qrib.
English: Oedema
Maltese: Loratadine
English: Flushing, hot flush
Maltese: Clozapine, pimozide
English: Amlodipine/Valsartan
Maltese: Astemizole, terfenadine
English: Quincke oedema
Maltese: AUC Cmin
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: 8.4 g 14 prefilled syringes
Maltese: 8.4 g 14 Siringi mimlijien
English: 8.4 g 7 pre-filled syringes
Maltese: 8.4 g 7 Siringi mimlijien
English: 8.4 g 1 pre-filled syringe
Maltese: 8.4 g 1 Siringa mimlija
English: 2 bottles with dosing syringe
Maltese: 1 Kunjett Mhux applikabbli
English: Virological failure ITT/e*#
Maltese: Falliment viroloġiku ITT/e*#
English: Lidocaine (systemic) Quinidine
Maltese: Lidocaine (sistemiku) Quinidine
English: Antipsychotics Lurasidone
Maltese: Antipsikotiċi Lurasidone
English: Titanium dioxide (E 171), Talc,
Maltese: Titanium dioxide (E 171),
English: Immunosuppressants Tacrolimus
Maltese: Immunosoppressanti Tacrolimus
English: TQT Study Day 3* (n=57)
Maltese: Jum 3 ta' Studju TQT* (n=57)
English: Midazolam AUC ↑ 12.4 fold Midazolam Cmax ↑ 4.3 fold Midazolam t1/2 ↑ from 4.7 h to 14.9 h
Maltese: Midazolam AUC ↑ 12.4 darbiet Midazolam Cmax ↑ 4.3 darbiet Midazolam t1/2 ↑ minn 4.7 h għal 14.9 h
English: • The active substance is saquinavir.
Maltese: • Is-sustanza attiva hi saquinavir.
English: Simvastatin ↑↑
Maltese: Simvastatin ↑↑ Lovastatin ↑↑
English: Gastroenterological medicinal products Metoclopramide
Maltese: Prodotti mediċinali gastro-enteroloġiċi Metoclopramide
English: Mean ± SD Saquinavir (%CV) Pharmacokinetic Parameters*
Maltese: Medja ± SD (%CV) tal-Parametri Farmakokinetiċi ta' Saquinavir *
English: Table 6: Subject Demographics MaxCmin1 and MaxCmin2†
Maltese: Tabella 6: Demografija tas-Suġġetti f'MaxCmin1 u MaxCmin2†
English: Study
Maltese: Studu
English: Tacrolimus may be associated with torsades de pointes.
Maltese: Tacrolimus jista' jiġi assoċjat ma' torsades de pointes.
English: Saquinavir AUC ↑ 4.6-7.2 fold
Maltese: - Saquinavir AUC ↑ 4.6-7.2 darbiet
English: HMG-CoA reductase inhibitors Pravastatin
Maltese: Inibituri ta' HMG-CoA reductase Pravastatin
English: Race (White/Black/Asian) % 86/9/1 Age, median, yrs
Maltese: Rażża (Bojod/Suwed/Asjatiċi) % 86/9/1 Eta', medjana, snin
English: * Saquinavir Mutation Score Mutations: L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M
Maltese: * Mutazzjonijiet ta' Punteġġ ta' Mutazzjoni għal Saquinavir: L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M
English: Age Group (Years)
Maltese: Grupp ta' Età (Snin)
English: Stevens Johnson syndrome, dermatitis bullous
Maltese: Sindrome ta' Stevens Johnson, dermatite blinfafet
English: Date of latest renewal: 04 October 2006
Maltese: Data tal-aħħar tiġdid: 04 ta' Ottubru 2006
English: * Sum of rifabutin + 25-O-desacetyl rifabutin metabolite
Maltese: * Għadd totali ta' rifabutin + ilmetabolit 25-O-desacetyl rifabutin
English: Tacrolimus is a substrate of CYP3A4 and P-glycoprotein.
Maltese: Tacrolimus huwa sottostrat ta' CYP3A4 u ta' P-glycoprotein.
English: • clinically relevant bradycardia
Maltese: • bradikardija ta' rilevanza klinika
English: Invirase contains lactose
Maltese: Invirase fih lactose
English: Roche Pharma AG Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
Maltese: Roche Pharma AG Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Il-Ġermanja.
English: • antifungals - ketoconazole, itraconazole, fluconazole, miconazole
Maltese: • mediċini kontra l-moffa - ketoconazole, itraconazole, fluconazole, miconazole
English: • previous history of symptomatic arrhythmias
Maltese: • passat ta' arritmija sintomatika
English: Calcium channel blockers Felodipine, nifedipine, nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ritonavir)
Maltese: Felodipine, nifedipine, nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ritonavir)
English: One plastic (HDPE) bottle contains 120 tablets.
Maltese: Flixkun talplastik (HDPE) fih 120 pillola.
English: Day 14
Maltese: Jum 14
English: • Clinical Management:
Maltese: • Immaniġġjar Kliniku:
English: Ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (saquinavir/ritonavir)
Maltese: Alkalojdi ergot (eż. ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (saquinavir/ritonavir)
English: Week 1:
Maltese: Ġimgħa 1:
English: • various steroids - such as dexamethasone, ethinyl estradiol, fluticasone
Maltese: • diversi sterojdi - bħal dexamethasone, ethinyl estradiol, fluticasone
English: It is a member of a class of medicines called protease inhibitors.
Maltese: Huwa membru ta' klassi ta' prodotti mediċinali msejħin inibituri tal-protease.
English: • medicines for erectile dysfunction - sildenafil, vardenafil, tadalafil
Maltese: • mediċini għal disfunżjoni erettili - sildenafil, vardenafil, tadalafil
English: Other potential interactions Medicinal products that are substrates of CYP3A4 e.g. dapsone, disopyramide, quinine, fentanyl, and alfentanyl
Maltese: Interazzjonijiet potenzjali oħra Prodotti mediċinali li huma substrati ta' CYP3A4 eż. dapsone, disopyramide, quinine, fentanyl, u alfentanyl
English: Saquinavir ↑ 50% (normal strength grapefruit juice)
Maltese: - Saquinavir ↑ 50 % (meraq tal grejpfrut ta' qawwa normali)
English: PR intervals of > 200 msec were seen in 3% of subjects in the active control group (moxifloxacin) and 5% in the placebo arm.
Maltese: Intervalli PR ta' > 200 msec kien osservat fi 3% tal-individwi fil-grupp ikkontrollat b'mod attiv (moxifloxacin) u f'5% fil-grupp tal-plaċebo.
English: • certain antibiotics - such as quinupristin/dalfopristin, rifabutin, fusidic acid
Maltese: • xi antibijotiċi - bħal quinupristin/dalfopristin, rifabutin, fusidic acid
English: • certain heart medicines - amiodarone, bepridil, disopyramide, dofetilide, flecainide,
Maltese: • ċertu mediċini tal-qalb - amiodarone, bepridil, disopyramide, dofetilide, flecainide,
English: Invirase is used by HIV-1-infected adults.
Maltese: Invirase huwa użat minn adulti infettati bl-HIV-1.
English: A similar interaction with astemizole is likely.
Maltese: Interazzjoni simili ma' astemizole hija probabbli.
English: Digoxin AUC0-72 ↑ 49% Digoxin Cmax ↑ 27%
Maltese: Digoxin AUC0-72 ↑ 49 % Digoxin Cmax ↑ 27 % Livelli ta' digoxin jistgħu jkunu differenti maż-żmien.
English: Marcelin et al (2007) identified nine protease codons (L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M) that were associated with decreased virological response to saquinavir/ritonavir (1000/100 mg twice daily) in 138 saquinavir naive patients.
Maltese: Marcelin et al (2007) identifika disa' kodons tal-protease (L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M) li kienu assoċjati ma' tnaqqis fir-rispons viroloġiku għal saquinavir/ritonavir (1000/100 mg darbtejn kuljum) f'138 pazjent li qatt ma ħadu saquinavir qabel.
English: • anticonvulsants - such as phenobarbital, phenytoin, carbamazepine
Maltese: • antikonvulsivi - bħal phenobarbital, phenytoin, carbamazepine
English: An interaction is possible.
Maltese: Interazzjoni hija possibbli.
English: • medicines for anticoagulation - warfarin
Maltese: • mediċini kontra l-koagulazzjoni - warfarin
English: • medicines for other severe mental health problems - such as clozapine, haloperidol,
Maltese: • medicini għall-problemi ta' saħħa mentali severa oħra - bħal clozapine, haloperidol,
English: The corresponding values in the control group were 28.5 (71%) µg·hr/ml and 4.3 (68%) µg/ml.
Maltese: Il-valuri li jikkorrispondu fil-grupp ta' kontroll kienu 28.5 (71%) µg·hr/ml u 4.3 (68%) µg/ml.
English: Day 7
Maltese: Jum 7
English: • The other ingredients (excipients) are microcrystalline cellulose, croscarmellose sodium, povidone, lactose (monohydrate) 38.5 mg, magnesium stearate, hypromellose, titanium dioxide (E171), talc, glycerol triacetate, iron oxide yellow (E172) and iron oxide red (E172).
Maltese: • Is-sustanzi l-oħra (eċċipjenti) huma microcrystalline cellulose, croscarmellose sodium, povidone, 38.5 mg lattosju (monohydrate), magnesium stearate, hypromellose, titanium dioxide (E171), talc, glycerol triacetate, iron oxide isfar (E172) u iron oxide aħmar (E172).
English: Cobicistat containing medicinal products Cobicistat
Maltese: Prodotti mediċinali li fihom cobicistat Cobicistat
English: Hepatitis, jaundice
Maltese: Epatite, suffejra
English: • concurrent therapy with any of the following drugs, which may interact and result in potentially life-threatening undesirable effects (see sections 4.4, 4.5 and 4.8): - drugs that prolong the QT and/or PR interval (see sections 4.4 and 4.5) - midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), triazolam (potential for prolonged or increased sedation, respiratory depression) - simvastatin, lovastatin (increased risk of myopathy including rhabdomyolysis) - ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (potential for acute ergot toxicity) - rifampicin (risk of severe hepatocellular toxicity) (see sections 4.4, 4.5, and 4.8) - quetiapine (risk of coma, see section 4.5).
Maltese: • terapija fl-istess waqt b'xi waħda mill-mediċini li ġejjin, li jista' jkollhom effett fuq xulxin u jwasslu għal effetti mhux mixtieqa b'potenzjal li jkunu fatali (ara sezzjonijiet 4.4, 4.5 u 4.8) mediċini li jtawlu l-intervall QT u/jew PR (ara sezzjonijiet 4.4 u 4.5) midazolam mogħti mill-ħalq (għall-kawtela dwar midazolam mogħti b'mod parenterali, ara sezzjoni 4.5), triazolam (potenzjal għal sedazzjoni mtawla jew aktar qawwija, dipressjoni respiratorja) simvastatin, lovastatin (żjieda fir-riskju ta' mijopatija inkluż rhabdomyolysis) ergot alkaloids (eż. ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (potenzjal għal tossiċità akuta ta' ergot) rifampicin (riskju ta' tossiċità epatoċellolari severa) (ara sezzjonijiet 4.4, 4.5, u 4.8) quetiapine (riskju ta' koma, ara sezzjoni 4.5). lurasidone (potenzjal għal reazzjonijiet serji u/jew ta' theddida għall-ħajja, (ara sezzjoni
English: In the therapeutic and the supra-therapeutic arm 11% and 18% of subjects, respectively, had a QTcS between 450 and 480 msec.
Maltese: Filgrupp terapewtiku u supra-terapewtiċi 11% u 18% tal-individwi, rispettivament, kellhom QTcS bejn 450 u 480 msec.
English: Saquinavir ↑ 100% (double strength grapefruit juice)
Maltese: - Saquinavir ↑ 100 % (meraq talgrejpfrut ta' qawwa doppja)
English: Fluticasone propionate ↑ Intrinsic cortisol ↓ 86% (90% CI 82%-89%) Greater effects may be expected when fluticasone propionate is inhaled.
Maltese: Fluticasone propionate ↑ Cortisol intrinsiku ↓ 86 % (90 % CI 82 %-89 %) Wieħed jista' jistenna effetti akbar meta fluticasone propionate jittieħed man-nifs.
English: * All parameters normalized to a 50 mg/kg dose
Maltese: * Il-parametri kollha normalizzati għal doża ta' 50 mg/kg
English: ECG and PK measurements were collected on Days 3, 4, 7, 10, and 14 of treatment with the modified Invirase/ritonavir treatment.
Maltese: Kejl ta' ECG u PK sar f'jiem 3, 4, 7, 10, u 14 tal-kura b'kura modifikata ta' Invirase/ritonavir.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) - Delavirdine
Maltese: Inibituri ta' non-nucleoside reverse transcriptase (NNRTIs)
English: St. John's wort (unboosted saquinavir)
Maltese: John's wort (saquinavir/
English: Proportion with VL < 50 copies/ml at week 48, ITT/e#
Maltese: Proporzjon b'VL < 50 kopji/ml wara 48 ġimgħa, ITT/e
English: Lactose (monohydrate), Magnesium stearate.
Maltese: Lactose (monohydrate),
English: Invirase contains the active substance saquinavir which is an antiviral agent.
Maltese: Invirase fih is-sustanza attiva saquinavir li huwa sustanza antivirali.
English: MARKETING AUTHORISATION NUMBER EU/1/96/026/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/026/002
English: The low bioavailability is thought to be due to a combination of incomplete absorption and extensive firstpass metabolism.
Maltese: Il-bijodisponibilità baxxa huwa maħsub li hija minħabba l-kombinazzjoni ta' assorbiment inkomplut u metaboliżmu first-pass estensiv.
English: Table 8: Mean (% CV) AUC, Cmax and Cmin of saquinavir in patients following multiple dosing of Invirase, saquinavir soft capsules, Invirase/ritonavir, and saquinavir soft capsules/ritonavir
Maltese: Tabella 8: Medja (% CV) ta' AUC, tas-Cmax u tac-Cmin f'pazjenti wara dożi multipli ta' Invirase, kapsoli rotob ta' saquinavir, u Invirase/ritonavir, u kapsoli rotob ta' saquinavir/ritonavir
English: It has been shown that saquinavir is approximately 97 % bound to plasma proteins up to 30 µg/ml.
Maltese: Intwera li saquinavir huwa bejn wieħed u ieħor 97 % magħqud mal-proteini tal-plażma sa 30 µg/ml.
English: INFORMATION IN BRAILLE invirase 500 mg
Maltese: invirase 500 mg
English: • certain medicines for infection - such as clarithromycin, dapsone, erythromycin, halofantrine,
Maltese: • ċertu mediċini għall-infezzjonijiet bħal clarithromycin, dapsone, erythromycin, halofantrine,
English: • certain medicines for severe mental health problems such as pimozide
Maltese: • ċertu mediċini għal problemi tas-saħħa mentali severi bħal pimozide
English: Paediatric Patients: Steady state pharmacokinetic information is available from HIV-infected paediatric patients from study NV20911.
Maltese: Tagħrif farmakokinetiku fi stat fiss huwa disponibbli minn pazjenti pedjatriċi infettati b'HIV mill-istudju NV20911.
English: Disease (COPD) such as salmeterol
Maltese: Pulmun (COPD) bħal salmeterol