FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that Talmanco contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adcirca.
Maltese: Dan ifisser li Talmanco fih l-istess sustanza attiva u jaħdem blistess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Adcirca.
English: EMA/323431/2014 EMEA/H/C/003698
Maltese: EMEA/H/C/003698
English: The full EPAR and risk management plan summary for Simbrinza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Simbrinza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Simbrinza.
English: Other information about Simbrinza
Maltese: Informazzjoni oħra dwar Simbrinza
English: The average reduction in intra-ocular pressure with Simbrinza after 3 months was 8.5 mmHg compared with 8.3 mmHg with the combination.
Maltese: It-tnaqqis medju fil-pressjoni intra-okulari b'Simbrinza wara 3 xhur kien 8.5 mmHg meta mqabbel ma' 8.3 mmHg bil-kombinazzjoni.
English: The reduction in intra-ocular pressure after 3 months was greater in patients using Simbrinza (an average fall of 7.9 mmHg) than in those using either brinzolamide or brimonidine tartrate (6.5 and 6.4 mmHg, respectively).
Maltese: It-tnaqqis fil-pressjoni intra-okulari wara 3 xhur kien ikbar f'pazjenti li kienu qed jużaw Simbrinza (tnaqqis medju ta' 7.9 mmHg) minn f'dawk li kienu qed jużaw jew il-brinzolamide jew il-brimonidine tartrate (6.5 u 6.4 mmHg, rispettivament).
English: One main study involved 560 patients with ocular hypertension or open-angle glaucoma, whose average intra-ocular pressure before treatment, measured in units called mmHg, was 26 mmHg.
Maltese: Studju wieħed ewlieni involva 560 pazjenti b'ipertensjoni okulari jew glawkoma b'angolu miftuħ, li kellhom medja ta' pressjoni intra-okulari qabel il-kura, mkejla b'unitajiet imsejħa mmHg, ta' 26 mmHg.
English: Brinzolamide works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate needed for the production of the aqueous humour, while brimonidine tartrate blocks another enzyme known as adenylate cyclase, which is also involved in the production of the aqueous humour.
Maltese: Il-brinzolamide jaħdem billi jimblokka enzima msejħa carbonic anhydrase, li tipproduċi bikarbonat neċessarju għall-produzzjoni tal-aqueous humour, filwaqt li l-brimonidine tartrate jimblokka enzima oħra magħrufa bħala adenylate cyclase, li hija wkoll involuta fil-produzzjoni tal-aqueous humour.
English: Why is Simbrinza approved?
Maltese: Għaliex ġie approvat Simbrinza?
English: What are the risks associated with Simbrinza?
Maltese: X'inhuma r-riskji assoċjati ma' Simbrinza?
English: A second main study involving 890 patients compared Simbrinza with a combination treatment of brinzolamide and brimonidine tartrate given as separate drops.
Maltese: It-tieni studju ewlieni li involva 890 pazjent qabbel Simbrinza ma' kura kkombinata oħrajn talbrinzolamide u l-brimonidine tartrate li ngħataw bħala qtar separat.
English: The active substances in Simbrinza, brinzolamide and brimonidine tartrate, help to reduce intra-ocular pressure by reducing the production of aqueous humour.
Maltese: Is-sustanzi attivi f'Simbrinza, il-brinzolamide u l-brimonidine tartrate, jgħinu biex titnaqqas il-pressjoni intra-okulari billi jnaqqsu l-produzzjoni tal-aqueous humour.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Simbrinza on 18 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Simbrinza fit-18 ta' Lulju 2014.
English: Simbrinza is an eye drop solution that contains two active substances: brinzolamide and brimonidine tartrate.
Maltese: Simbrinza huwa soluzzjoni għat-taqtir fl-għajnejn li fiha żewġ sustanzi attivi: brinzolamide u brimonidine tartrate.
English: The most common side effects in studies with Simbrinza were ocular hyperaemia (red eye) and allergic reactions in the eye, which occurred in about 6 to 7% of patients, and dysgeusia (taste disturbances) in about 3% of patients.
Maltese: L-effetti sekondarji l-aktar komuni b'Simbrinza kienu iperemija okulari (għajn ħamra) u reazzjonijiet allerġiċi fl-għajn, li seħħew f'madwar 6 sa 7% tal-pazjenti, u disgewżja (disturbi fit-togħma) f'madwar 3% tal-pazjenti.
English: Open-angle glaucoma (a condition where the aqueous humour, the watery fluid inside the eyeball, cannot drain away properly) and other causes of high pressure in the eye increase the risk of damage to the retina and the optic nerve (the nerve that sends signals from the eye to the brain).
Maltese: Glawkoma b'angolu miftuħ (kundizzjoni fejn l-aqueous humour, il-fluwidu milwiemi ġewwa l-għajn, ma jistax jiskula sew) u kawżi oħrajn ta' pressjoni għolja fl-għajn iżidu r-riskju ta' ħsara lir-retina u nnervitura ottika (in-nervitura li tibgħat sinjali mill-għajn għall-moħħ).
English: Simbrinza is used when treatment with other medicines containing only one active substance have been tried but has not reduced the intra-ocular pressure sufficiently.
Maltese: Simbrinza jintuża meta kura b'mediċini oħrajn li fihom sustanza attiva waħda biss jiġu ppruvati iżda ma jnaqqsux il-pressjoni intra-okulari b'mod suffiċjenti.
English: This summary was last updated in 07-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 07-2014.
English: Simbrinza is used to reduce intra-ocular pressure (pressure inside the eye) in adults with ocular hypertension (high intra-ocular pressure) or in those with an eye condition known as open-angle glaucoma.
Maltese: Simbrinza jintuża biex inaqqas il-pressjoni intra-okulari (pressjoni ġewwa l-għajn) f'adulti b'ipertensjoni okulari (pressjoni intra-okulari għolja) jew f'dawk b'kundizzjoni tal-għajnejn magħrufa bħala glawkoma b'angolu miftuħ.
English: A risk management plan has been developed to ensure that Simbrinza is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Simbrinza jintuża bl-aktar mod sigur possibbli.
English: What measures are being taken to ensure the safe and effective use of Simbrinza?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Simbrinza?
English: Simbrinza must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, or to sulphonamides (a class of antibiotics).
Maltese: Simbrinza m'għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għas-sustanzi attivi, għal xi wieħed mill-ingredjenti l-oħrajn, jew għal sulfonamidi (klassi ta' antibijotiċi).
English: Simbrinza was shown to be as effective as the combination treatment.
Maltese: Simbrinza ntwera li huwa effettiv daqs il-kura kkombinata.
English: How does Simbrinza work?
Maltese: Kif jintuża Simbrinza?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Simbrinza was shown to be more effective than either active substance used alone and at least as effective as the combination of the active substances given as separate eye drops.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li Simbrinza ntwera li huwa aktar effettiv miż-żewġ sustanzi attivi użati waħedom u ta' lanqas effettiv daqs ilkombinazzjoni tas-sustanzi attivi mogħtija bħala qtar separati.
English: The CHMP therefore concluded that Simbrinza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għalhekk, is-CHMP iddeċieda li lbenefiċċji ta' Simbrinza huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: It is available as capsules (white: 1.5 mg; pink: 3 mg; orange: 4.5 mg; orange and pink: 6 mg).
Maltese: Huwa disponibbli f'forma ta' kapsuli (bojod: 1.5 mg; roża: 3 mg; oranġjo: 4.5 mg; oranġjo u roża: 6 mg).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RIVASTIGMINE TEVA EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) RIVASTIGMINE TEVA Sommarju tal-EPAR għall-pubbliku
English: Rivastigmine Teva is a ‘generic medicine'.
Maltese: Teva hija ‘mediċina ġenerika'.
English: The active substance in Rivastigmine Teva, rivastigmine, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Rivastigmine Teva, rivastigmina, hija mediċina kontra d-demenza.
English: The European Commission granted a marketing authorisation valid throughout the EU for Rivastigmine Teva to Teva Pharma B.V. on 17 April 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rivastigmine Teva lil Teva Pharma B.V. fil-17 ta' April 2009.
English: This means that Rivastigmine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Maltese: Teva huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Exelon.
English: What are the benefit and risk of Rivastigmine Teva?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Rivastigmine Teva?
English: Because Rivastigmine Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (the two medicines produce the same levels of the active substance in the body).
Maltese: Minħabba li Rivastigmine Teva huwa mediċina ġenerika, l-istudji ġew limitati għal testijiet biex jiġi determinat li huwa bijoekwivalenti għall-mediċina ta' referenza (jiġifieri li ż-żewġ mediċini jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem).
English: Rivastigmine Teva is a medicine containing the active substance rivastigmine.
Maltese: Teva huwa mediċina li fiha s-sustanza attiva rivastigmina (rivastigmine).
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Maltese: Rivastigmina taħdem billi timblokka l-enzimi li jkissru l-aċetilkolina: aċetilkolinesterażi (acetylcholinesterase) u butirilkolinesterażi (butyrylcholinesterase).
English: In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Maltese: Jekk din id-doża tirriżulta tollerata sew, tista' tiżdied b'1.5 mg kull doża waħda, iżda mhux iktar frekwenti minn ġimagħtejn bejn żieda u oħra, sakemm tintlaħaq doża regolari ta' 3-6 mg darbtejn kuljum.
English: What is Rivastigmine Teva?
Maltese: X'inhu Rivastigmine Teva?
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Maltese: Fil-pazjenti b'demenza tat-tip Alzheimer jew b'demenza dovuta għall-marda ta' Parkinson, ċerti ċelluli nervużi talmoħħ imutu, b'hekk dan jirriżulta f'livelli baxxi tan-newrotrasmettitur aċetilkolina (acetylcholinesustanza kimika li tħalli ċ-ċelluli nervużi jikkomunikaw ma' xulxin).
English: Why has Rivastigmine Teva been approved?
Maltese: Għaliex ġie approvat Rivastigmine Teva?
English: Rivastigmine Teva can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Maltese: Teva jista' wkoll jintuża għat-trattament tad-demenza minn ħafifa għal moderatament gravi f'pazjenti bil-marda ta' Parkinson.
English: Rivastigmine Teva is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Dan it-tip ta' demenza huwa disturb tal-moħħ progressiv li jolqot gradwalment il-memorja, l-abilità intellettiva u l-imġiba.
English: The full EPAR for the reference medicine can also be found on the EMEA's website.
Maltese: L-EPAR sħiħ għall-mediċina ta' referenza jista' jinstab ukoll fuq is-sit tal-internet tal-EMEA.
English: This summary was last updated in 04-2009.
Maltese: Dan is-sommarju ġie aġġornat fi: 02-2009.
English: How does Rivastigmine Teva work?
Maltese: Għal xiex jintuża Rivastigmine Teva?
English: The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Maltese: Id-doża massima rakkomandata hija 6 mg darbtejn kuljum.
English: Rivastigmine Teva allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Maltese: Billi jimblokka dawn l-enzimi, Rivastigmine Teva jippermetti żieda fil-livelli ta' aċetilkolina fil-moħħ u b'dan il-mod jgħin biex inaqqas is-sintomi taddemenza tat-tip Alzheimer u tad-demenza dovuta għall-marda ta' Parkinson.
English: Because Rivastigmine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Minħabba li Rivastigmine Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Other information about Rivastigmine Teva:
Maltese: Kif taħdem Rivastigmine
English: Treatment with Rivastigmine Teva should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Maltese: It-trattament b'Rivastigmine Teva għandu jibda u jiġi mmonitorjat minn tabib li għandu l-esperjenza fid-dijanjożi u fit-trattament tal-marda ta' Alzheimer jew fid-demenza f'pazjenti bil-marda ta' Parkinson.
English: How has Rivastigmine Teva been studied?
Maltese: Il-Kumitat irrakkomanda li Rivastigmine
English: System Organ Class Frequency
Maltese: Sistema talKlassifika talOrgani Frekwenza
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Maltese: ANTAGONIST ALPHA 1-ADRENORECEPTOR Alfuzosin
English: OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Maltese: Ma kienx hemm evidenza tumoriġenika fil-ġrieden u fil-firien irġiel.
English: LOC. FONTANA DEL CERASO, ANAGNI, 03012, Italy
Maltese: LOC. FONTANA DEL CERASO, ANAGNI, 03012, L-Italja
English: GASTROINTESTINAL MOTILITY AGENTS Cisapride
Maltese: GASTROINTESTINALI Cisapride
English: ATC code: J05AR15
Maltese: J05AR15
English: Immunosuppressants
Maltese: Immunosuppressanti
English: SEDATIVES/HYPNOTICS Midazolam
Maltese: SEDATTIVI/IPNOTIĊI Midazolam
English: *Lack of pharmacokinetics interaction bounds 70-143%
Maltese: *Nuqqas ta' interazzjoni farmakokinetika fil-medda ta' bejn 70-143%
English: CCR5 Antagonists
Maltese: Antagonisti ta' CCR5
English: EU/1/15/1025/001 30 film-coated tablets EU/1/15/1025/002 90 (3 bottles of 30) film-coated tablets
Maltese: EU/1/15/1025/001 30 pillola miksijin b'rita EU/1/15/1025/002 90 (3 fliexken ta' 30) pillola miksijin b'rita
English: Table 2: Tabulated summary of adverse reactions
Maltese: Tabella 2: Sommarju tabulat ta' reazzjonijiet avversi
English: PC: SN: <NN>:
Maltese: <NN>:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1025/001-002
Maltese: EU/1/15/1025/001-002
English: Atazanavir with cobicistatf (n = 344)
Maltese: Atazanavir ma' cobicistatf (n = 344)
English: Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Maltese: Cobicistat jinibixxi t-trasporaturi p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 u OATP1B3.
English: Atazanavir with ritonavirf (n = 348)
Maltese: Atazanavir ma' ritonavirf (n = 348)
English: Risk Management Plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (Risk Management Plan, RMP)
English: Atazanavir is an azapeptide HIV-1 protease inhibitor (PI).
Maltese: Atazanavir huwa inibitur ta' protease HIV-1 ta' azapeptide (PI).
English: HORMONAL CONTRACEPTIVES Progestin/estrogen
Maltese: Progestin/estrogen
English: Diltiazem Cmax ↑98% (↑78%
Maltese: Cmax ta' Diltiazem ↑98 % (↑78 %
English: Table 1: Interactions between EVOTAZ and other medicinal products Medicinal products by therapeutic area
Maltese: Tabella 1: Interazzjonijiet bejn EVOTAZ u prodotti mediċinali oħra
English: Raltegravir AUC ↑72% Raltegravir Cmax ↑53% Raltegravir C12hr ↑95%
Maltese: Raltegravir AUC ↑72 % Cmax ta' Raltegravir ↑53 % C12hr ta' Raltegravir ↑95 %
English: HIV-1 RNA <50 copies/ml
Maltese: Suċċess viroloġiku HIV-1 RNA <50 kopja/mL
English: HMG-CoA reductase inhibitors
Maltese: Inibituri ta' reductase HMG-CoA
English: HCV Protease Inhibitors
Maltese: Inibituri ta' Protease HCV
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Maltese: Inibituri ta' Nucleoside Reverse Transcriptase (Nucleoside/nucleotide reverse transcriptase inhibitors, NRTIs)
English: Cobicistat AUC ↔ Cobicistat Cmax ↔ Cobicistat Cmin ↑232%
Maltese: AUC ta' Cobicistat ↔ Cmax ta' Cobicistat ↔ Cmin ta' Cobicistat ↑232 %
English: Table 3: Virologic outcome of randomised treatment of study GS-US-216-0114 at weeks 48a and 144b
Maltese: Tabella 3: Eżitu viroloġiku ta' kura randomizzata ta' studju GS-US-216-0114 fil-ġimgħat 48a u 144b
English: Cobicistat has no antiviral activity.
Maltese: Cobicistat ma għandu ebda attività antivirali.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Maltese: Inibituri ta' Mhux Nucleoside Reverse Transcriptase (Non-nucleoside reverse transcriptase inhibitors, NNRTIs)
English: PDE5 Inhibitors
Maltese: Inibituri tal-PDE5
English: Grade 3 or 4 elevation of total bilirubin was noted in 37% (6% Grade 4).
Maltese: Żieda ta' bilirubin totali ta' grad 3 jew 4 ġiet innotata (37 % (6 % Grad 4).
English: Quetiapine Lurasidone
Maltese: ANTIPSIKOTIĊI Pimozide Quetiapine Lurasidone
English: Antineoplastics
Maltese: Antineoplastiċi
English: Steady-state cobicistat Cmax, AUCtau and Ctau (mean ± SD) values were 1.5 ± 0.5 μg/ml, 11.1 ± 4.5 μg•hr/ml and 0.05 ± 0.07 μg/ml, respectively (n=22).
Maltese: Il-valuri Cmax, AUCtau u Ctau (SD medju) ta' cobicistat fi stat fiss kienu 1.5 ± 0.5 μg/ml, 11.1 ± 4.5 μg•siegħa/ml u 0.05 ± 0.07 μg/ml, rispettivament (n=22).
English: AUC: ↑23% Cmin: ↑55%
Maltese: ↑23% Cmin: ↑55 %
English: Digoxin (0.5 mg single dose)/cobicistat (150 mg multiple doses)
Maltese: Digoxin (0.5 mg doża waħda)/cobicistat (150 mg dożi multipli)
English: boceprevir AUC ↔5% boceprevir Cmax ↔7% boceprevir Cmin ↔18%
Maltese: boceprevir AUC ↔5 % Cmax ta' boceprevir ↔7 % Cmin ta' boceprevir ↔18 %
English: Alternative antibiotics should be considered.
Maltese: Għandhom jiġu kkunsidrati antibijotiċi alternattivi.
English: Glecaprevir AUC : ↑553% Glecaprevir Cmax : ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC : ↑11% (↑3% Atazanavir Cmax : ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Maltese: Glecaprevir AUC : ↑553% Glecaprevir Cmax : ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC : ↑11% (↑3% Atazanavir Cmax : ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * L-effett ta' atazanavir u ritonavir fuq l-ewwel doża ta' glecaprevir u pibrentasvir huwa rrapportat.
English: Didanosine Cmin ↑13% (↓9%
Maltese: Cmin ta' Didanosine ↑13 % (↓9 %
English: ANTIDIABETICS Metformin
Maltese: ANTIDIJABETIĊI Metformin
English: In GS-US-216-0114, 3.6% of subjects were hepatitis B virus surface antigen positive and 5.3% were hepatitis C virus seropositive.
Maltese: F'GS-US-216-0114, 3.6% tal-individwi kienu pożittivi għall-antiġen tal-wiċċ tal-virus tal-epatite B u 5.3% kienu seropożittivi għall-virus tal-epatite Ċ.
English: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
Maltese: Is-sindrome ta' Stevens-Johnsona,b, raxx bl-infafet, ekżema, vażodilazzjoni
English: Atazanavir binds to both alpha-1-acid glycoprotein (AAG) and albumin to a similar extent (89% and 86%, respectively, at 1,000 ng/ml).
Maltese: Atazanavir jingħaqad kemm mal-glikoproteina alpha-1-acid (AAG) kif ukoll mal-albumina b'ammont simili (89 % u 86 % rispettivament f'1,000 ng/ml).
English: 90 (3 bottles of 30) film-coated tablets.
Maltese: 90 (3 pakketti ta' 30) pillola miksijin b'rita.
English: Didanosine Cmax ↓36% (↓45%
Maltese: Cmax ta' Didanosine ↓36 % (↓45 %
English: Cardiac disorders uncommon torsades de pointesa rare
Maltese: Disturbi fil-qalb mhux komuni torsades de pointesa rari
English: Clarithromycin Cmin ↑160%
Maltese: Cmin ta' Clarithromycin ↑160 %
English: EVOTAZ contains two active substances: atazanavir, an antiviral (or antiretroviral) medicine.
Maltese: EVOTAZ fih żewġ sustanzi attivi: atazanavir, mediċina antivirali (jew antiretrovirali).
English: Cobicistat: AUC: ↔ Cmax: ↔ Cmin: ↓66%
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↓66 %
English: Norbuprenorphine AUC ↑105% Norbuprenorphine Cmax ↑61% Norbuprenorphine Cmin ↑101%
Maltese: Cmax ta' Norbuprenorphine ↑61 % Cmin ta' Norbuprenorphine ↑101 %
English: 25-O-desacetyl-rifabutin AUC
Maltese: 25-O-desacetyl-rifabutin:
English: Drospirenone AUC: ↑ 130% Drospirenone Cmax: ↔ Drospirenone Cmin: Not calculated
Maltese: Drospirenone AUC: ↑ 130% Drospirenone Cmax: ↔ Drospirenone Cmin: Mhux ikkalkulat
English: atazanavir AUC ↓35% atazanavir Cmax ↓25% atazanavir Cmin ↓49%
Maltese: AUC ta' atazanavir ↓35 % Cmax ta' atazanavir ↓25 % Cmin ta' atazanavir ↓49 %
English: Ethinyloestradiol AUC: ↔ Ethinyloestradiol Cmax: ↔ Ethinyloestradiol Cmin: Not calculated
Maltese: ↔ Ethinyloestradiol Cmax: ↔ Ethinyloestradiol Cmin: Mhux ikkalkulat
English: Atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Maltese: Atazanavir jesibixxi attività kontra l-HIV-1 (inkluż il-gruppi ttestjati kollha) u kontra l-attività ta' HIV-2 fil-kultura taċ-ċelloli.
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 ilpożoloġija ma tista' tingħata.
English: Adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to 1/1,000).
Maltese: Ir-reazzjonijiet avversi huma elenkati minn klassifika tas-sistema tal-organi u l-frekwenza: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) u rari (≥1/10,000 sa 1/1,000).
English: Treatment difference -2.2% (95% CI = -7.4%, 3.0%) -2.1% (95% CI = -8.7%, 4.5%) Virologic failurec
Maltese: -2.1% (95 % CI = -8.7%, 4.5%)
English: Amiodarone Dronedarone Quinidine Systemic lidocaine
Maltese: Amiodarone Dronedarone Quinidine
English: Patients co-infected with hepatitis B and/or hepatitis C virus
Maltese: Pazjenti ko-infettati bil-virus tal-epatite B u/jew l-epatite Ċ
English: The median baseline plasma HIV-1 RNA was 4.81 log10 copies/ml (range: 3.21-6.44).
Maltese: L-HIV-1 RNA medjan fil-plażma fil-linja bażi kien ta' 4.81 log10 kopji/ml (medda: 3.21-6.44).
English: Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Maltese: Sildenafil, tadalafil, u vardenafil huma metabolizzati minn CYP3A4.
English: EVOTAZ 300 mg/150 mg film-coated tablets atazanavir/cobicistat
Maltese: EVOTAZ 300 mg/150 mg pilloli miksijin b'rita atazanavir/cobicistat