FrancophonIA/ELRC3.0 huggingface dataset:
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95%CI=0.64-0.96, p=0.0195).
Maltese: Wara li bdiet il-kura bi pemetrexed flimkien ma' cisplatin (4 ċikli), il-kura bi pemetrexed kienet statistikament superjuri għal plaċebo għall-OS (medjan 13.9 xhur kontra 11.0 xhur, hazard ratio = 0.78, 95%CI=0.
English: In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g., ibuprofen) or acetylsalicylic acid at higher doses should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Maltese: F'pazjenti li jkollhom insuffiċjenza renali ħafifa għal moderata (tneħħija tal-kreatinina bejn 45 sa 79 ml/min) l-għoti ta' pemetrexed fl-istess żmien ma' NSAIDs (eż. ibuprofen) jew acetylsalicylic acid f'dożi għoljin għandu jkun evitat minn jumejn qabel, dakinhar u sa jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.4).
English: The pharmacokinetic properties of pemetrexed are not influenced by concurrently administered cisplatin.
Maltese: Il-proprjetajiet farmakokinetiċi ta' pemetrexed mhumiex influwenzati bl-għoti fl-istess ħin ta' cisplatin.
English: Dose modification table for pemetrexed (as a single agent or in combination) and cisplatin - neurotoxicity
Maltese: Tabella 3. Tabella għall-modifikazzjoni tad-doża għal pemetrexed (bħala terapija b'sustanza unika jew ikkombinata) u cisplatin - newrotossiċità
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1,000 mg
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni. 1,000 mg
English: Clinically relevant CTC toxicities that were reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f'< 1% (mhux komuni) tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu cisplatin u pemetrexed jinkludu arritmija u newropatija motorja.
English: Type I glass vial with bromobutyl rubber stopper containing 100 mg, 500 mg or 1,000 mg of pemetrexed
Maltese: Kunjett tal-ħġieġ ta' Tip I b'tapp tal-lasktu tal-bromobutyl li fih 100 mg, 500 mg jew 1,000 mg ta' pemetrexed.
English: The recommended dose of cisplatin is 75 mg/m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Maltese: Id-doża rakkomandata ta' cisplatin hi ta' 75 mg/m2 BSA infuża fuq perijodu ta' sagħtejn madwar 30 jum wara li tkun saret l-infużjoni ta' pemetrexed fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Oedema
Maltese: Zaventem
English: Blood clots in the lung blood vessels (pulmonary embolism)
Maltese: Ċapep tad-demm fis-sistema vaskulari tal-pulmun (emboliżmu pulmunarju)
English: PC GC
Maltese: PC:
English: Once in the cell, pemetrexed is rapidly and efficiently converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase.
Maltese: La darba jkun fiċ-ċellula, pemetrexed jiġi konvertit malajr u b'mod effiċjenti f'forom ta' poliglutamati permezz tal-enzima folylpolyglutamate synthetase.
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kimoterapija preċedenti, id-doża rakkomandata ta' pemetrexed hi ta' 500 mg/m2 BSA mogħti b'infużjoni minn ġol-vina fuq perjodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: This suggests that pemetrexed may impair male fertility.
Maltese: Ir-riskju jikber f'persuni li jkunu diġà immunosoppressi minħabba l-marda li jkollhom.
English: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Maltese: Mid-939 pazjent li bdew il-kura bi pemetrexed flimkien ma' cisplatin, 539 pazjent ġew magħżula b'mod każwali biex jieħdu kura ta' manteniment b'pemetrexed jew plaċebo.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
Maltese: KARTUNA TA' BARRA TA' 100 mg
English: Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Maltese: B'mod rari, f'pazjenti kkurati b'pemetrexed, ġiet irrapportata l-anemija emolitika kkawżata missistema immunitarja stess.
English: Patients received a median of 5 cycles of maintenance treatment with pemetrexed and 3.5 cycles of placebo.
Maltese: Il-pazjenti rċevew medjan ta' 5 ċikli ta' kura ta' manteniment bi pemetrexed u 3.5 ċikli ta' plaċebo.
English: Immunodepressed status is common in cancer patients.
Maltese: L-immunodipressjoni hija komuni f'pazjenti li jkollhom kanċer.
English: Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Maltese: Tossiċitajiet klinikament rilevanti li ġew irrapportati f'< 1% tal-pazjenti li b'mod każwali ntgħażlu biex jirċievu cisplatin u pemetrexed jinkludu: żieda fil-GGT, uġigħ fis-sider, arritmija, u newropatija motorja.
English: Subsequent vitamin B12 injections may be given on the same day as pemetrexed.
Maltese: B12 bħala supplimentazzjoni.
English: The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Maltese: Il-farmakokinetiċi ta' pemetrexed huma konsistenti f'diversi ċikli ta' kura.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 100 mg
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni. 100 mg
English: Leucocytes decreased 12.1 4.2 Haemoglobin decreased 19.2 4.2 Common Platelets decreased
Maltese: Tnaqqis finnewtrofili/granuloċiti Tnaqqis fil-lewkoċiti 12.1 4.2 Tnaqqis fl-emoglobina
English: Pemetrexed Pfizer is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Maltese: Pemetrexed Pfizer tingħata flimkien ma' cisplatin, mediċina oħra ta' kontra l-kanċer, bħala kura għal mesoteljoma plewrali malinna, tip ta' kanċer li jaffettwa r-rita tal-pulmun, lil pazjenti li jkunu għadhom ma ngħatawx kimoterapija.
English: Pharmaceutical Form Route of Administration
Maltese: Għamla farmaċewtika
English: (Invented) name Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Immediate Packaging
Maltese: Matriċi Siġillanti
English: The active substance in Amyvid, florbetapir (
Maltese: Is-sustanza attiva f'Amyvid, florbetapir (
English: This is a summary of the European public assessment report (EPAR) for Amyvid.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Amyvid.
English: The type of scan used with Amyvid is called positron emission tomography (PET).
Maltese: It-tip ta' immaġini użat b'Amyvid jissejjaħ tomografija bl-emissjoni tal-positroni (PET).
English: This summary was last updated in 01-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi 01-2013.
English: Amyvid delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Maltese: Amyvid iwassal ammont baxx ħafna ta' radjazzjoni b'riskju minimu ta' kanċer jew ta' xi abnormalitajiet ereditarji.
English: Other information about Amyvid
Maltese: Informazzjoni oħra dwar Amyvid:
English: The specificity of the PET scans was 100% in 47 healthy volunteers, which means that all of their scans were rated as negative after being read by experts who were not aware if the scans belonged to healthy people or to patients.
Maltese: L-ispeċifiċità tal-PET scans kienet ta' 100% fuq 47 voluntiera b'saħħithom, li jfisser li l-immaġini kollha tagħhom kienu kklassifikati bħala negattivi wara li nqraw minn esperti li ma kinux jafu jekk l-immaġnijiet kinux ta' persuni b'saħħithom jew ta' pazjenti.
English: The most common side effect with Amyvid (seen in between 1 and 10 patients in 100) is headache.
Maltese: L-aktar effett sekondarju komuni b'Amyvid (li deher f'bejn 1 u 10 pazjenti minn kull 100) huwa uġigħ ta' ras.
English: Amyvid is given by injection into a vein about 30 to 50 minutes before obtaining an image from a PET scan.
Maltese: Amyvid jingħata permezz ta' injezzjoni ġo vina madwar nofs siegħa sa 50 minuta qabel ma tinkiseb immaġini minn PET scan.
English: A negative scan indicates sparse or no β-amyloid plaques, which means that the patient is unlikely to have Alzheimer's disease.
Maltese: Scan negattiv jindika plakek skarsi tat-tip β-amyloid jew l-ebda plakek, li jfisser li mhux probabbli li lpazjent għandu l-marda tal-Alzheimer.
English: β-amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease, Lewy body dementia and Parkinson's disease dementia) and some elderly people with no symptoms.
Maltese: Plakek tat-tip β-amyloid huma depożiti li xi kultant ikunu preżenti fl-imħuħ ta' pazjenti bid-dimenzja (bħall-marda ta' Alzheimer, dimenzja b'Lewy body u dimenzja fil-marda ta' Parkinson) u f'xi anzjani mingħajr ebda sintomu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Amyvid on 14 January 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Amyvid fi Fl-14 ta' Jannar 2013.
English: Amyvid is a solution for injection that contains the active substance florbetapir (
Maltese: Amyvid huwa soluzzjoni għal injezzjoni li fiha s-sustanza attiva florbetapir (
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 92% and a specificity of 100%.
Maltese: Meta r-riżultati tal-awtopsji ġew imqabbla mal-PET scans, l-immaġini intwerew li kellhom sensittività ta' 92% u speċifiċità ta' 100%.
English: After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Amyvid.
Maltese: Wara li tinkiseb l-immaġini, tinqara minn tobba tal-mediċina nukleari imħarrġa speċifikament fl-interpretazzjoni ta' PET scans b'Amyvid.
English: Why has Amyvid been approved?
Maltese: Għaliex ġie approvat Amyvid?
English: What measures are being taken to ensure the safe use of Amyvid?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Amyvid?
English: What is Amyvid?
Maltese: X'inhu Amyvid?
English: Amyvid must not be used in people who are hypersensitive (allergic) to florbetapir (18F) or any of the other ingredients.
Maltese: Amyvid ma għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għal florbetapir (18F) jew għal xi wieħed mis-sustanzi l-oħra.
English: The CHMP did, however, note that, partly due to the limited effects of current treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Amyvid.
Maltese: Madankollu, is-CHMP innota li, parzjalment minħabba l-effetti limitati tal-kura attwali għall-marda ta' Alzheimer, ma hemmx evidenza b'saħħitha ta' titjib immedjat fl-immaniġġjar ta' pazjenti jew fir-riżultati ta' pazjenti wara PET scans b'Amyvid.
English: This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other neurodegenerative diseases.
Maltese: Dan huwa meqjus bħala titjib sinifikanti fid-dijanjosi ta' pazjenti bi problemi bil-memorja li qegħdin jiġu evalwati għall-marda ta' Alzheimer u mard newrodeġenerattiv ieħor.
English: What is the risk associated with Amyvid?
Maltese: X'inhu r-riskju assoċjat ma' Amyvid?
English: The effects of Amyvid were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Amyvid ġew l-ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbnedmin.
English: PET scans with Amyvid were shown to have high specificity and sensitivity when used for identifying which patients had significant amounts of β-amyloid plaques in the brain.
Maltese: PET scans b'Amyvid intwerew li kellhom speċifiċità u sensittività għolja meta użati għall-identifikazzjoni ta' pazjenti li kellhom ammonti sinifikanti ta' plakek tat-tip β-amyloid fil-moħħ.
English: The medicine can only be obtained with a prescription.
Maltese: Il-mediċina tista' tinkiseb biss bi preskrizzjoni medika.
English: F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Maltese: F), hija radjufarmaċewtika li tarmi ammonti baxxi ta' radjazzjoni u taħdem billi timmira u teħel ma' plakek tat-tip β-amyloid fil-moħħ.
English: This means that the PET scans were able to correctly identify as positive 92% of the patients who had significant amounts of plaques, and that all patients without significant plaques were correctly rated as negative.
Maltese: Dan ifisser li l-PET scans kienu kapaċi jidentifikaw b'mod korrett bħala pożittivi 92% tal-pazjenti li kellhom ammonti sinifikanti ta' plakek, u li l-pazjenti kollha mingħajr plakek sinifikanti kienu kklassifikati korrettament bħala negattivi.
English: The Committee noted the good safety profile and non-invasive nature of the PET scans with Amyvid and concluded that
Maltese: Il-Kumitat innota l-profil tajjeb ta' sigurtà u n-natura mhux invażiva tal-PET scans b'Amyvid u kkonkluda li l-benefiċċji ta' Amyvid huma akbar mirriskji tiegħu.
English: Among the patients, 59 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Maltese: Fost il-pazjenti, 59 sarulhom awtopsji biex jiġi ppruvat b'mod konklussiv jekk kellhomx ammonti sinifikanti ta' plakek tat-tip β-amyloid fl-imħuħ tagħhom jew le.
English: PET scans with Amyvid were shown to have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Maltese: PET scans b'Amyvid intwerew li kellhom sensittività u speċifiċità għolja biex jiskopru plakek tat-tip βamyloid fil-moħħ, bir-riżultati tal-immaġini jirriflettu mill-qrib dak li deher fl-awtopsji.
English: In addition, the usefulness of Amyvid in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Maltese: Barra minn hekk, l-utilità ta' Amyvid fit-tbassir tal-iżvilupp talmarda ta' Alzheimer f'pazjenti bi problemi fil-memorja jew fil-monitoraġġ tar-rispons ta' pazjenti għallkura ma ġietx stabbilita.
English: The company that markets Amyvid will provide access to a training course for all nuclear medicine physicians expected to use this product in the EU in order to ensure accurate and reliable reading of the PET scan images.
Maltese: Il-kumpanija li tqiegħed Amyvid fis-suq sejra tipprovdi aċċess għal kors ta' taħriġ għat-tobba kollha tal-mediċina nukleari mistennija li jużaw dan il-prodott fl-UE sabiex jiġi żgurat qari preċiż u affidabbli tal-immaġini tal-PET scans.
English: A main study was conducted in 226 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died.
Maltese: Studju ewlieni sar fuq 226 voluntier maqsuma f'żewġ gruppi: grupp ta' żgħażagħ b'saħħithom u grupp ta' pazjenti li waslu fl-aħħar ta' ħajjithom li kienu taw il-kunsens tagħhom għal awtopsji wara mewthom.
English: How has Amyvid been studied?
Maltese: Kif ġie studjat Amyvid?
English: Amyvid is for diagnostic use only.
Maltese: Amyvid huwa għall-użu dijanjostiku biss.
English: A positive scan on its own, however, is not sufficient to make a diagnosis in patients with memory problems, as plaque deposition may be seen in patients with different types of neurodegenerative dementias as well as in elderly people with no symptoms.
Maltese: Immaġini pożittiva weħidha, madankollu, mhijiex biżżejjed biex issir dijanjosi f'pazjenti bi problemi bil-memorja, peress li depożiti ta' plakka jistgħu jidhru fuq pazjenti b'tipi differenti ta' dimenzji newrodeġenerattivi kif ukoll fuq anzjani mingħajr ebda sintomi.
English: As of week 144:
Maltese: Minn ġimgħa 144:
English: See Table 1.
Maltese: Ara Tabella 1.
English: 32 (9 to 55)
Maltese: 32 (9 sa 55)
English: Antiviral activity in vitro
Maltese: Attività antivirali in vitro
English: 117 Allée des Parcs, 69 800 Saint Priest, France
Maltese: 117 Allée des Parcs, 69800 Saint Priest, Franza
English: to 200 μg/mL.
Maltese: 02-200 μg/mL.
English: IMMUNOSUPPRESSANTS
Maltese: IMMUNOSUPPRESSANTI
English: 41 (4 to 79)
Maltese: 41 (4 sa 79)
English: Difference (95%CI)
Maltese: Differenza (95%CI)
English: Antiretrovirals
Maltese: Antiretrovirali
English: Age (Yrs), Median (Q1, Q3)
Maltese: Età (Snin), Medjana (Q1, Q3)
English: There is limited metabolism of emtricitabine.
Maltese: Hemm metaboliżmu limitat ta' emtricitabine.
English: Clinical data
Maltese: Dejta klinika
English: McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Maltese: McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 L-Irlanda
English: Ethnicity
Maltese: Etniċità
English: ATC code: J05AR03
Maltese: J05AR03
English: Seroconversions / N
Maltese: Serokonverżjonijiet / N
English: Seroconversions / Na
Maltese: Serokonverżjonijiet / Na
English: 8% (-1% to 17%)
Maltese: 8% (-1% sa 17%)
English: Gender, N (%) Male
Maltese: Sess, N (%) Maskili Femminili
English: P-valuea, b mITT Analysis
Maltese: P-valuea, b
English: angioedema3
Maltese: anġjoedema3
English: Placebo (n = 1248)
Maltese: Plaċebo (n = 1248)
English: Opportunistic infections
Maltese: Infezzjonijiet opportunistiċi
English: Each tablet contains 93.6 mg lactose monohydrate.
Maltese: Kull pillola fiha 93.6 mg ta' lactose monohydrate.
English: Importance of adherence:
Maltese: L-importanza tal-aderenza:
English: Placebo (n = 1584)
Maltese: Plaċebo (n = 1584)
English: Medis International a.s vyrobani zavod Bolatice,Prumyslova, -961/16, Bolatice 747 23, Czech Republic
Maltese: Medis International a.s vyrobani zavod Bolatice, Prumyslova, -961/16, Bolatice 747 23, ir-Repubblika Ċeka
English: Age (Yrs), Mean (SD) Race, N (%) Black/African American White Mixed/Other Asian Hispanic/Latino Ethnicity, N (%) Sexual Risk Factors at Screening
Maltese: Età (Snin), Medja (SD) Razza, N (%) Suwed/Afro-Amerikani Bojod Imħalltin/Oħrajn Asjatiċi Etniċità Ispanika/Latina, N (%) Fatturi ta' Riskju Sesswali fl-Iskrinjar
English: Medis International a.s Bolatice, Prumyslova 961/16, 747 23 Bolatice, Czech Republic
Maltese: Medis International a.s Bolatice, Prumyslova 961/16, 747 23 Bolatice, ir-Repubblika Ċeka
English: 11% (4% to 19%)
Maltese: 11% (4% sa 19%)
English: NC = not calculated
Maltese: NC = mhux ikkalkulat (not calculated).
English: Mitochondrial dysfunction following exposure in utero
Maltese: Disfunzjoni mitokondrijali wara esponiment in utero
English: Salomone Pharma Ltd Tel: + 356 212 01 74
Maltese: V.J. Salomone Pharma Ltd Tel: + 356 212 01 74
English: • amphotericin B (for fungal infection)
Maltese: • amphotericin B (għal infezzjoni fungali)
English: • interleukin-2 (to treat cancer)
Maltese: • interleukin-2 (għat-trattament tal-kanċer)
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: ANTI-INFECTIVES
Maltese: ANTI-INFETTIVI
English: 9% (2% to 17%)
Maltese: 9% (2% sa 17%)
English: Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Maltese: Tenofovir disoproxil jinbdel in vivo għal tenofovir, li huwa analogu ta' nucleoside monophosphate (nucleotide) analogu ta' adenosine monophosphate.
English: 13% (4% to 22%)
Maltese: 13% (4% sa 22%)
English: Mylan Hungary Kft Mylan utca 1, H-2900 Komárom, Hungary
Maltese: Mylan Hungary Kft Mylan utca 1, H-2900
English: EU/1/16/1133/001 EU/1/16/1133/002 EU/1/16/1133/003 EU/1/16/1133/004 EU/1/16/1133/005 EU/1/16/1133/006
Maltese: EU/1/16/1133/001 EU/1/16/1133/002 EU/1/16/1133/003 EU/1/16/1133/004
English: Multipack: 90 (3 bottle packs of 30) film-coated tablets
Maltese: Pakkett multiplu: 90 (3 pakketti bil-flixkun ta' 30) pillola miksija b'rita
English: 2 The predominant circulating metabolite of sofosbuvir.
Maltese: 2 Il-metabolit predominanti ta' sofosbuvir fiċ-ċirkolazzjoni.
English: Herpes virus antiviral agents Famciclovir/Emtricitabine
Maltese: Aġenti antivirali għall-virus tal-herpes Famciclovir/Emtricitabine
English: elevated creatine kinase
Maltese: creatine kinase għolja
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Synergistic antiviral activity was observed with the combination of emtricitabine and tenofovir in vitro.
Maltese: Attività antivirali sinerġistika dehret bil-kumbinazzjoni ta' emtricitabine u tenofovir in vitro.
English: Triple nucleoside therapy
Maltese: Terapija ta' nucleosides tripli
English: Moderate renal impairment (CrCl 30-49 mL/min)
Maltese: Indeboliment tal-kliewi moderat (CrCl 30-49 mL/min)
English: • increased creatine kinase Common side effects
Maltese: • creatine kinase għolja Effetti sekondarji komuni
English: Pre-exposure prophylaxis (PrEP):
Maltese: Profilassi ta' qabel l-esponiment (pre-exposure prophylaxis, PrEP):
English: HIV-1 RNA < 50 copies/mL (TLOVR) p-value % difference (95%CI)
Maltese: RNA tal-HIV-1 < 50 kopja/mL (TLOVR) Valur p % differenza (95%CI)
English: Emtricitabine is a nucleoside analogue of cytidine.
Maltese: Emtricitabine huwa analogu tan-nukleosidi ta' cytidine.
English: Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (see section 4.4).
Maltese: Xi eżempji jinkludu, iżda mhumiex limitati għal, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir jew interleukin-2 (ara sezzjoni 4.4).
English: Subjects were followed for 7,830 person-years.
Maltese: L-individwi kienu segwiti għal 7,830 sena ta'persuna.
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/mL) and CD4 counts (233 and 241 cells/mm3).
Maltese: Fil-linja bażi, il-gruppi randomised kellhom medjan simili ta' l-RNA tal-HIV-1 tal-plażma (5.02 u 5.00 log10 kopja/mL) u ta' l- għadd tas-CD4 (233 u 241 ċelluli/mm3).
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Maltese: Il-frekwenzi huma deskritti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) jew rari (≥ 1/10,000 sa < 1/1,000).
English: Number with Tenofovir Detected/ Total Samples (%)
Maltese: Numru b'Tenofovir Skopert /Kampjuni Totali (%)
English: HIV-1 RNA < 400 copies/mL (TLOVR) p-value % difference (95%CI)
Maltese: RNA tal-HIV-1 < 400 kopja/mL (TLOVR) Valur p % differenza (95%CI)
English: Cmin: ↓ 21% (↓ 58 to ↑ 48)
Maltese: Cmin: ↓ 21% (↓ 58 sa ↑ 48)
English: Date of first authorisation: 16 December 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Diċembru 2016
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Maltese: Emtricitabine triphosphate u tenofovir diphosphate jinibixxu kompetittivament ir-reverse transcriptase ta' l-HIV-1 li jirriżulta fit-terminazzjoni tal-katina tad-DNA.