FrancophonIA/ELRC3.0 huggingface dataset:
English: During a median of 18 months following discontinuation of teriparatide, there was a 41% reduction (p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral fracture.
Maltese: Matul medja ta' 18-il xahar wara l-waqfien tal-kura b'teriparatide, kien hemm 41 % tnaqqis (p=0.004) meta mqabbel mal-plaċebo fin-numru ta' pazjenti b'minimu ta' ksur waħdani vertebrali ġdid.
English: In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving teriparatide.
Maltese: F' prova klinika kbira, l-antikorpi li ġew cross-reacted ma' teriparatide instabu f'2.8 % tan-nisa li ngħataw teriparatide.
English: Pregnancy Movymia is contraindicated for use during pregnancy (see section 4.3).
Maltese: Tqala Waqt it-tqala l-użu ta' Movymia huwa kontra-indikat (ara sezzjoni 4.3).
English: No data are available in patients with impaired hepatic function (see section 5.3).
Maltese: M' hemmx informazzjoni dwar pazienti b'indeboliment fil-funzjoni tal-fwied (ara sezzjoni 5.3.).
English: {Displayed in case of 1x and 3x cartridges only.
Maltese: {Jidhru fil-każ ta' 1x u 3x skrataċ biss.
English: Overdose experience based on post-marketing spontaneous reports In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 micrograms) of a teriparatide pen have been administered as a single dose.
Maltese: Esperjenza ta' doża eċċessiva bbażata fuq rapporti spontanji wara t-tqegħid fis-suq F'rapporti spontanji wara t-tqegħid fis-suq, kien hemm każijiet ta' żbalji fil-medikazzjoni fejn ilkontenut kollu (sa 800 mikrogramma) ta' pinna ta' teriparatide ngħata f'doża waħda.
English: 1 cartridge 3 cartridges
Maltese: 1 skartoċċ 3 skrataċ
English: Placebo (N = 544) (%)
Maltese: Każijiet ta' Ksur fin-Nisa Wara l-Menopawża Plaċebo (N=544) (%)
English: Renal failure/impairment
Maltese: Insuffiċjenza/inde boliment renali
English: • BD Micro-Fine Ultra needles 29 to 31 gauge (diameter 0.25 - 0.33 mm) and 12.7, 8 or 5 mm length Pen needles from other manufacturers can be used according to their stated compatibility details.
Maltese: Ultra labar 29 sa 31 gejġ (dijametru 0.25 - 0.33 mm) u tul ta' 12.7, 8 jew 5 mm Labar tal-pinna minn manifatturi oħrajn jistgħu jintużaw skont id-dettalji tal-kompatibbiltà ddikjarati tagħhom.
English: • the pen being used with a medical device, accessories or consumables other than those recommended by XXXXXXXXXXX.
Maltese: • meta l-pinna tintuża ma' apparat mediku, aċċessorji jew oġġetti intiżi għall-użu minbarra dawk rakkomandati minn XXXXXXXXXXX.
English: Possible allergic events soon after injection: acute dyspnoea, oro/facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral)
Maltese: Il-possibiltà ta' avvenimenti allerġiċi ftit wara l-injezzjoni: qtugħ ta' nifs akut, edima orali/talwiċċ, urtikarja ġeneralizzata, uġigħ fis-sider, edima (l-iżjed periferali)
English: Myalgia, arthralgia, back cramp/pain*
Maltese: Mijalġja, artralġja, bugħawwieġ/uġig ħ fid-dahar*
English: Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Maltese: Glacial acetic acid, sodium acetate trihydrate, mannitol, metacresol, ilma għall-injezzjonijiet, hydrochloric acid (għall-aġġustament tal-pH) u sodium hydroxide (għall-aġġustament tal-pH).
English: Each cartridge contains 2.4 mL of solution corresponding to 28 doses of 20 micrograms (per 80 microliters).
Maltese: Kull skartoċċ fih 2.4 mL ta' soluzzjoni li tikkorrispondi għal 28 doża ta' 20 mikrogramma (għal kull 80 mikrolitru).
English: Movymia contains sodium
Maltese: Movymia fih is-sodium
English: Hypercalcaemia greater than 3.25 mmol/L
Maltese: Livell għoli ta' kalċju fid-demm iżjed minn 3.25 mmol/L
English: 3 mL cartridge (siliconised Type I glass), with a plunger stopper (bromobutyl) and disc seal (aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and packed in a carton.
Maltese: Skartoċċ ta' 3mL(ħġieġ silikoniżżat tat-Tip I) b' tapp planġer (bromobutyl) u siġill fil- forma ta' diska (aluminium u siġilli b'kisja tal-lasktu), ippakkjati fi trej tal-plasik issiġillat b'għatu tal-fojl u ppakkjati f'kartuna.
English: Each Movymia cartridge contains 28 doses of fixed 80 microlitres Movymia.
Maltese: Kull Movymia skartoċċ fih 28 doża ta' 80 mikrolitru fiss ta' Movymia.
English: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis
Maltese: Inkontinenza urinarja, tgħaddi ammont eċċessiv ta' awrina, urġenza biex tgħaddi l- awrina, nefrolitjażi (nephrolithiasis)
English: Movymia cartridge and pen pack: 1 Movymia cartridge packed in a plastic tray sealed with lid foil and packed in a carton and 1 Movymia Pen packed into a separate carton.
Maltese: Movymia skartoċċ 1 ippakkjat fi trej tal-plastik issiġillat b'għatu tal-fojl u ppakkjat f'kartuna u Movymia Pen 1 ippakkjata f'kartuna separata.
English: Nausea, vomiting, hiatus hernia, gastrooesophageal reflux disease
Maltese: Tqalligħ, rimettar, ħiatus hernia, mard ta' rifluss gastro-esofagali
English: What Movymia contains - The active substance is teriparatide.
Maltese: - Is-sustanza attiva hi teriparatide.
English: In clinical trials, 2.8% of teriparatide patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients.
Maltese: Fil-provi kliniċi, 2.8 % tal-pazjenti li ħadu teriparatide kellhom konċentrazzjonijiet ta' uric acid fis-serum ogħla mill-limitu ta' fuq tannormal meta mqabbel ma' 0.7 % ta' pazjenti li ġew ikkurati bil-plaċebo.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: - The other ingredients are: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma: glacial acetic acid, mannitol, metacresol, sodium acetate trihydrate, hydrochloric acid (għall-aġġustament tal-pH), sodium hydroxide (għall-aġġustament tal-pH), u ilma għall-injezzjoni.
English: The Movymia Pen has a service life of two years.
Maltese: It-Movymia Pen għandha ħajja operattiva ta' sentejn.
English: Deutschland STADAPHARM GmbH Tel: + 49 61016030
Maltese: GmbH Tel: + 49 61016030
English: Animal studies have shown that severely reduced hepatic blood flow decreases exposure of PTH to the principal cleavage system (Kupffer cells) and consequently clearance of PTH(1-84).
Maltese: L-istudji fl-annimali wrew li ċ-ċirkolazzjoni mnaqqsa ħafna tad-demm fil-fwied inaqqas l-espożizzjoni ta' PTH għas-sistema prinċipali ta' cleavage (ċelluli ta' Kupffer) u konsegwentement it-tneħħija ta' PTH(1-84).
English: Instructions for use Movymia Pen
Maltese: Istruzzjonijiet għall-użu Movymia Pen
English: Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo patients reported at least 1 adverse event.
Maltese: F' pazjenti fil-provi b'teriparatide, 82.8 % tal-pazjenti li ħadu teriparatide u 84.5 % tal-pazjenti li ħadu l-plaċebo rrappurtaw għall-inqas effett wieħed avvers.
English: • Transport and store the Movymia Pen with inserted cartridge at temperatures specified in the Movymia package leaflet, provided separately.
Maltese: • Ittrasporta u aħżen it-Movymia Pen bl-iskartoċċ imdaħħal f'temperaturi speċifikati fil-fuljett ta' tagħrif ta' Movymia, ipprovdut separatament.
English: After 12 months, BMD had increased in the lumbar spine and total hip by 5% and 1%, respectively, compared with placebo.
Maltese: Wara 12-il xahar, BMD kien żdied fil-għadma tal-ġenbejn b'5 % u 1 % rispettivament meta mqabbel ma' plaċebo.
English: Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide.
Maltese: Il-konċentrazzjonijiet ta' calcium fis-serum jilħqu massimu bejn 4 u 6 sigħat u jirritornaw lura bħal qabel bejn 16 u 24 siegħa wara kull doża ta' teriparatide.
English: Hypercholesterolaemia
Maltese: Soluzzjoni għall-injezzjoni
English: Do not use alcohol, other solvents or cleaning agents.
Maltese: Tużax alkoħol, solventi jew aġenti oħra tattindif.
English: Do not use your Movymia Pen to inject any other medicine (e.g. insulin).
Maltese: Tużax Movymia Pen tiegħek biex tinjetta xi mediċina oħra (eż. insulina).
English: In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively.
Maltese: Bejn it-18 u l-24 xahar, fil-pazjenti kkurati b'teriparatide, il-BMD talparti lumbari tas-sinsla, tat-total tal-ġenbejn u tal-għonq femorali żdied b'1.7 %, b'0.9 % u b'0.4 % ieħor rispettivament.
English: The pen and injection needles are not included with Movymia.
Maltese: Il-pinna u l-labar tal-injezzjoni mhumiex inklużi ma' Movymia.
English: Movymia 20 mcg/80 mcL injection teriparatide
Maltese: Movymia 20 µg/80 µL injezzjoni teriparatide
English: The efficacy of teriparatide in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18-month primary phase of a 36-month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).
Maltese: Osteoporożi kkawżata minħabba t-teħid ta' glukokortikojdi L-effikaċja ta' teriparatide f'irġiel u nisa (N=428) li kienu qed jirċievu terapija bil-glukokortikojdi b'mod sistemiku fit-tul (ekwivalenti għal 5 mg jew iżjed ta' prednisone meħuda għallinqas għal 3 xhur) ġiet murija fl-ewwel fażi ta' 18-il xahar ta' studju double-blind, randomised, ikkontrollat b'komparatur (alendronate 10 mg/jum) u li dam 36 xahar.
English: Do not repeat this before each daily injection, otherwise you will not have enough Movymia for 28 days.
Maltese: Tirrepetix dan qabel kull injezzjoni ta' kuljum, inkella mhux se jkollok biżżejjed Movymia għal 28 jum.
English: Movymia is used to treat osteoporosis in adults.
Maltese: Movymia jintuża għall-kura ta' l-osteoporożi fl-adulti.
English: • increase in blood uric acid level • increase in an enzyme called alkaline phosphatase.
Maltese: • żieda f'enzima msejħa alkaline phosphatase
English: Pack sizes:
Maltese: Manifattur legali:
English: Movymia cartridge and pen
Maltese: Movymia skartoċċ u pinna
English: Read the patient information leaflet for Movymia cartridge provided separately.
Maltese: Aqra l-fuljett ta' tagħrif għal Movymia skartoċċ ipprovdut separatament.
English: Movymia is supplied in a cartridge.
Maltese: Movymia huwa soluzzjoni bla kulur u ċara.
English: Movymia cartridges are to be used in Movymia Pen reusable, multidose pen device exclusively and must not be used with any other pen.
Maltese: Qabel tarmi t-Movymia Pen, dejjem neħħi llabra tal-pinna u l-iskartoċċ.
English: Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritus and minor bleeding at injection site
Maltese: Għeja, uġigħ fissider, astenja, avvenimenti ħfief u momentanji fissit ta' l-injezzjoni, li jinkludu wġigħ, nefħa, eritema, tbenġil lokalizzat, ħakk u xi ftit ta' fsada fis-sit ta' linjezzjoni
English: Movymia cartridge and pen pack:
Maltese: Movymia pakkett ta' skartoċċ u pinna:
English: • Put the Movymia Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after use.
Maltese: • Poġġi t-Movymia Pen, bl-iskartoċċ imdaħħal, lura fil-friġġ bejn 2 u 8 °C immedjatament wara l-użu.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3.
English: Movymia 20 micrograms/80 microliters solution for injection: 1 or 3 cartridges.
Maltese: Movymia 20 mikrogramma/80 mikrolitru soluzzjoni għall-injezzjoni: skartoċċ wieħed jew 3 skrataċ.
English: Movymia must not be transferred to a syringe.
Maltese: Movymia fih soluzzjoni ċara u mingħajr kulur.
English: You can use Movymia for up to 28 days after the first injection, as long as the cartridge/pen with the cartridge inserted is stored in a refrigerator (2 °C to 8 °C).
Maltese: Tista' tuża Movymia sa 28 jum wara l-ewwel injezzjoni diment li l-iskartoċċ/pinna bl-iskartoċċ imdaħħal ikun maħżun a fi friġġ (2°C - 8°C).
English: STADA Poland Sp. z.o o. Tel: + 48 227377920
Maltese: Laboratorio STADA, S.L. Tel: + 34 934738889
English: STADA Arzneimittel AG Τηλ: + 49 61016030
Maltese: Τηλ: + 49 61016030
English: The pen can be used with compatible pen needles.
Maltese: Il-pinna tista' tintuża ma' labar tal-pinna kompatibbli.
English: Movymia 20 micrograms/80 microliters solution for injection Teriparatide
Maltese: Movymia 20 microgramma/80 mikrolitri soluzzjoni għall-injezzjoni Teriparatide
English: The total duration of treatment with Movymia should not exceed 24 months.
Maltese: It-tul totali tal-kura b'Movymia m' għandux ikun aktar minn 24 xahar.
English: In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture within the previous 3 years (83% had received previous osteoporosis therapy) were treated with teriparatide for up to 24 months.
Maltese: F'studju open-label, 503 nisa wara l-menopawża b'osteoporożi severa u li kellhom ksur ta' fraġilità flaħħar 3 snin (83 % kienu diġà rċevew kura għall-osteoporożi) ġew ikkurati b'teriparatide għal 24 xahar.
English: Teriparatide is a bone formation agent to treat osteoporosis.
Maltese: Kull skartoċċ u pinna għandhom jintużaw minn pazjent wieħed biss.
English: If you become pregnant while using Movymia, Movymia should be discontinued.
Maltese: Jekk toħroġ tqila waqt li tuża Movymia, Movymia għandu jitwaqqaf.
English: Troubleshooting
Maltese: Disturbi vaskulari
English: Movymia 20 micrograms/80 microliters solution for injection
Maltese: Movymia 20 mikrogramma/80 mikrolitri soluzzjoni għall-injezzjoni
English: Never immerse the Movymia Pen in water, as this could damage the pen.
Maltese: Rimi ta' Movymia Pen u u aċċessorji użati
English: Write down the batch (Lot) number of each cartridge and its first injection date on a calendar.
Maltese: Niżżel in-numru tal-lott ta' kull skartoċċ qabel l-ewwel data ta' injezzjoni tiegħu fuq kalendarju.
English: Movymia cartridges are designed to be used only with the Movymia Pen reusable, multidose delivery system and compatible pen needles.
Maltese: L-iskrataċ ta' Movymia huma maħsuba biex jintużaw biss mas-sistema għall-għoti ta' ħafna dożi ta' Movymia Pen, li terġa' tintuża u ma' labar tal-pinna kompatibbli.
English: • Screw the pen needle clockwise onto the cartridge holder.
Maltese: Żomm l-iskartoċċ fil-kartuna ta' barra sabiex tilqa' mid-dawl.
English: If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Movymia.
Maltese: Jekk inti mara li tista' toħroġ tqila, għandek tuża metodi effettivi ta' kontraċezzjoni waqt l-użu ta' Movymia.
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Maltese: Biex titneħħa s-sospensjoni, id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ikun irid jipprovdi lill-Awtoritajiet Nazzjonali Kompetenti b'dan li ġej:
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATIONS
Maltese: ANNESS III KUNDIZZJONIJIET GĦALL-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ
English: • Detailed risk minimisation measures and ways to ensure that the impact of such measures could be adequately evaluated once in place.
Maltese: • Miżuri dettaljati għat-tnaqqis tar-riskju u mezzi biex ikun żgurat li l-impatt ta' miżuri bħal dawn ikunu jistgħu jiġu evalwati adegwatament ladarba jiddaħħlu.
English: • Data demonstrating that the products can be used safely taking into account information on intoxications from poison centres in Europe.
Maltese: • Tagħrif li juri li l-prodotti jkunu jistgħu jintużaw bla periklu meta wieħed jikkunsidra t-tagħrif fuq l-intossikazzjoni minn ċentri għas-sustanzi velenużi fl-Ewropa.
English: EU/1/04/305/001 EU/1/04/305/002
Maltese: EU/1/04/305/002
English: Race, N (%)
Maltese: Razza, N (%)
English: Κύπρος Gilead Sciences Ελλάς Μ.ΕΠΕ.
Maltese: Gilead Sciences Ελλάς Μ.ΕΠΕ.
English: section 4.4).
Maltese: (ara sezzjoni 4.4).
English: Age (Yrs), Mean (SD)
Maltese: Età (Snin), Medja (SD)
English: Age (Yrs), Median (Q1, Q3) Gender, N (%)
Maltese: Età (Snin), Medjana (Q1, Q3) Sess, N (%)
English: Black/African American
Maltese: Amerikani Suwed/Afro-Amerikani Bojod
English: Each tablet contains 96 mg lactose monohydrate.
Maltese: Kull pillola fiha 96 mg ta' lactose monohydrate.
English: Truvada contains lactose
Maltese: Truvada fih lactose
English: Truvada to Reduce the Risk of getting Human Immunodeficiency Virus (HIV) Infection'
Maltese: Truvada għat-Tnaqqis tar-Riskju li tieħu Infezzjoni tal-Virus ta' l-immunodefiċjenza Uman (HIV)'
English: Truvada contains lactose monohydrate.
Maltese: Eċċipjenti Truvada fih lactose monohydrate.
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: amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir jew interleukin-2 (ara sezzjoni 4.4).
English: Truvada comes in bottles of 30 tablets.
Maltese: Truvada tiġi fi fliexken ta' 30 pillola.
English: Serum Herpes Simplex Virus Type 2 Infection, N (%) Urine Leukocyte Esterase Positive, N (%)
Maltese: Infezzjoni tat-Tip 2 tal-Virus tas-Serum Herpes Simplex, N (%) Pożittiv għal Esterase Lewkoċiti fl-Awrina, N (%)
English: • increased creatine kinase
Maltese: • creatine kinase għolja
English: EU/1/04/305/001 30 film-coated tablets EU/1/04/305/002 90 (3 x 30) film-coated tablets
Maltese: EU/1/04/305/001 30 pillola miksija b'rita
English: elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
Maltese: aspartate aminotransferase (AST) fis serum għolja u/jew alanine aminotransferase (ALT) fis-serum għolja, iperbilirubinimja żieda fit-transaminases
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 talHIV-1 tal-plażma (5.02 u 5.00 log10 kopja/mL) u ta' l- għadd tas-CD4 (233 u 241 ċelluli/mm3).
English: Blue, capsule-shaped, film-coated tablet, of dimensions 19 mm x 8.5 mm, debossed on one side with “GILEAD” and on the other side with “701”.
Maltese: Pillola miksija b'rita, blu, forma ta' kapsula, b'daqs ta' 19 mm x 8.5 mm, b'“GILEAD” imnaqqxa fuq naħa waħda u “701” fuq in-naħa l-oħra.
English: • The importance of regular monitoring of renal function during Truvada therapy
Maltese: • L-importanza tal-monitoraġġ regolari tal-funzjoni tal-kliewi matul it-terapija bi Truvada
English: Truvada 200 mg/245 mg film-coated tablets Emtricitabine/tenofovir disoproxil
Maltese: Truvada 200 mg/245 mg pilloli miksija b'rita Emtricitabine/tenofovir disoproxil
English: Truvada P-valuea, b mITT Analysis
Maltese: P-valuea, b
English: Truvada (n = 1251)
Maltese: (n = 1251)
English: Date of first authorisation: 21 February 2005 Date of latest renewal: 20 January 2010
Maltese: Data tal-aħħar tiġdid: 20 ta' Jannar 2010
English: • difficulty with movement
Maltese: • diffikultà bil-moviment
English: The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min).
Maltese: Il-grad ta' indeboliment renali kien definit skond il-linja bażi tat-tneħħija tal-kreatinina (CrCl) (funzjoni renali normali meta CrCl > 80 mL/min; indeboliment ħafif b'CrCl = 50-79 mL/min; indeboliment moderat b'CrCl = 30-49 mL/min u indeboliment sever b'CrCl = 10-29 mL/min).
English: Table 2: Interactions between Truvada or its individual component(s) and other medicinal products
Maltese: Tabella 2: Interazzjonijiet bejn Truvada u l-komponent(i) individwali tiegħu u prodotti mediċinali oħra
English: • The other ingredients are croscarmellose sodium, glycerol triacetate (E1518), hypromellose (E464), indigo carmine aluminium lake (E132), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinised starch (gluten free) and titanium dioxide (E171).
Maltese: (E464), indigo carmine aluminium lake (E132), lactose monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), pregelatinised starch (gluten free) u titanium dioxide (E171).
English: There is close structural similarity between lamivudine and emtricitabine and similarities in the pharmacokinetics and pharmacodynamics of these two agents.
Maltese: Hemm similarità strutturali mill qrib bejn lamivudine u emtricitabine u similaritajiet fil-farmakokinetika u l-farmakodinamika ta' dawn iż-żewġ aġenti.
English: The Partners PrEP clinical study (CO-US-104-0380) evaluated Truvada, tenofovir disoproxil 245 mg, or placebo in 4,758 HIV-uninfected subjects from Kenya or Uganda in serodiscordant heterosexual couples.
Maltese: L-istudju kliniku Partners PrEP (CO-US-104-0380) evalwa Truvada, tenofovir disoproxil 245 mg, jew plaċebo f'4,758 individwu mhux infettati bl-HIV mill-Kenja jew l-Uganda f'koppji eterosesswali serodiskordanti.
English: Patients in the emtricitabine and tenofovir disoproxil group were given Truvada and efavirenz from week 96 to week 144.
Maltese: Ilpazjenti fil-grupp ta' emtricitabine u tenofovir disoproxil ingħataw Truvada u efavirenz minn ġimgħa 96 sa ġimgħa 144.
English: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering Truvada to older people.
Maltese: 65 sena huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta Truvada jingħata lil persuni anzjani.
English: AUC: ↔ Cmax: ↓ 19% (↓ 40 to ↑ 10)
Maltese: AUC: ↔ Cmax: ↓ 19% (↓ 40 sa ↑ 10)
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/mL and 2,050 (50.8%) ng•h/mL, respectively, in normal subjects compared with 289 (46.0%) ng/mL and 2,310 (43.5%) ng•h/mL in subjects with moderate hepatic impairment, and 305 (24.8%) ng/mL and 2,740 (44.0%) ng•h/mL in subjects with severe hepatic impairment.
Maltese: tal-valuri ta' Cmax u l-valuri ta' l-AUC0-∞ ta' tenofovir kienu ta' 223 (34.8%) ng/mL u 2,050 (50.8%) ng•h/mL rispettivament, f'individwi normali, meta pparagunata ma' 289 (46.0%) ng/mL u 2,310 (43.5%) ng•h/mL f'individwi b'indeboliment epatiku moderat, u 305 (24.8%) ng/mL u 2,740 (44.0%) ng•h/mL f'individwi b'indeboliment epatiku sever.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Maltese: emtricitabine ma' proteini tal-plażma umana kienet ta' < 4% u indipendenti mill-konċentrazzjoni filmedda ta' 0.
English: * Patients receiving emtricitabine, tenofovir disoproxil and efavirenz were given Truvada plus efavirenz from week 96 to ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic Response a: Van Elteren Test
Maltese: * Il-pazjenti li jkunu qed jirċievu emtricitabine, tenofovir disoproxil u efavirenz ngħataw Truvada flimkien ma' efavirenz minn ġimgħa 96 sa 144. ** Il-valur p ibbażat fuq it-Test ta' Cochran-Mantel-Haenszel stratifikat għal-linja bażi ta' l-għadd taċ-ċelluli CD4 TLOVR = Ħin sa nuqqas ta' respons viroloġiku a: Test ta' Van Elteren
English: How to store Truvada
Maltese: Plaċebo Truvada