FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions reported in the table below are derived from two clinical trials (including a total of 88 patients; median age 8 years [range 0-17 years]) where treosulfan combined with fludarabine (and mostly with additional thiotepa) was administered as conditioning treatment prior to alloHSCT in paediatric patients with malignant or non-malignant diseases.
Maltese: Ir-reazzjonijiet avversi rrappurtati fit-tabella t'hawn taħt huma derivati minn żewġ provi kliniċi (li jinkludu totali ta' 88 pazjent; età medjana ta' 8 snin [medda ta' 0-17-il sena]) fejn ingħata treosulfan flimkien ma' fludarabine (u fil-biċċa l-kbira ma' thiotepa addizzjonali) bħala trattament ta' kkondizzjonar qabel alloHSCT f'pazjenti pedjatriċi b'mard malinn jew mhux malinn.
English: • Fanconi anaemia and other DNA breakage repair disorders
Maltese: • Anemija ta' Fanconi u disturbi oħra tat-tiswija ta' ksur tad-DNA
English: A report from an investigator-initiated trial performed in children with primary immunodeficiencies lists four cases of seizures occurring after other treosulfan-based conditioning regimens (see section 4.4).
Maltese: Rapport minn prova mibdija minn investigatur li saret fi tfal b'immunodefiċjenzi primarji jelenka erba' każijiet ta' aċċessjonijiet li jseħħu wara korsijiet oħra ta' kkondizzjonar ibbażat fuq treosulfan (ara sezzjoni 4.4).
English: The possible risk of a second malignancy should be explained to the patient.
Maltese: Irriskju possibbli ta' tumur malinn sekondarju għandu jiġi spjegat lill-pazjent.
English: Therefore, infants ≤ 4 months of age should be monitored for signs of neurological adverse reactions.
Maltese: Għalhekk, trabi li għandhom ≤ 4 xhur għandhom jiġu mmonitorjati għal sinjali ta' reazzjonijiet avversi newroloġiċi.
English: Large bore needles are recommended to minimise pressure and the possible formation of aerosols.
Maltese: Labar b'kalibru kbir huma rakkomandati biex tiġi mminimizzata l-pressjoni u l-formazzjoni possibbli ta' aerosols.
English: • Treosulfan 10-14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0).
Maltese: • Treosulfan 10-14 g/m² tal-erja tas-superfiċje tal-ġisem (BSA - body surface area) kuljum bħala infużjoni ġol-vini ta' sagħtejn, mogħti fi tlett ijiem konsekuttivi (jum -6, -5, -4) qabel l-infużjoni taċ-ċelluli staminali (jum 0).
English: • a type of rash with flat or raised red bumps on the skin (maculopapular rash), red spots on the skin (purpura), redness of skin (erythema), hand and foot syndrome (palms of the hands or soles of the feet tingle, become numb, painfully swollen, or red), itching, hair loss
Maltese: • tip ta' raxx b'nefħiet ħomor ċatti jew imqabbża fuq il-ġilda (raxx bi tbajja' u nfafet), tikek ħomor fuq il-ġilda (purpura), ħmura tal-ġilda (eritema), sindrome tal-idejn u s-saqajn (il-pali tal idejn jew il-qigħan tas-saqajn inemnmu, titlef is-sensazzjoni fihom, jintefħu b'mod li jweġġa',jew jiħmaru), ħakk, telf tax-xagħar
English: Use of mucositis prophylaxis (e.g. topical antimicrobials, barrier protectants, ice and adequate oral hygiene) is recommended.
Maltese: L-użu ta' profilassi talmukożite (eż. antimikrobjali topiċi, prottettur tal-barriera mukożali, silġ u iġjene orali adegwata) huwa rakkomandat.
English: Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara “JIS”.
English: After reconstitution with sodium chloride 4.5 mg/mL (0.45%) solution, chemical and physical stability has been demonstrated for 2 days at 25 °C.
Maltese: Wara r-rikostituzzjoni b'soluzzjoni ta' sodium chloride 4.5 mg/mL (0.45%), l-istabbiltà kimika u fiżika ntweriet għal jumejn f'temperatura ta' 25°C.
English: Package leaflet: Information for the user Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion treosulfan
Maltese: Informazzjoni għall-utent Trecondi 1 g trab għal soluzzjoni għall-infużjoni Trecondi 5 g trab għal soluzzjoni għall-infużjoni Treosulfan
English: Not known Renal failure, cystitisc, dysuria
Maltese: • diffikultà biex tieħu nifs, tinfaġar
English: After reconstitution 1 mL of solution contains 50 mg treosulfan.
Maltese: Wara r-rikostituzzjoni, 1 mL tas-soluzzjoni jkun fih 50 mg ta' treosulfan.
English: • skin ulcer, a type of rash with red spots and sometimes with purple or blistered areas in the centre (erythema multiforme), hives, skin condition with fluid-filled blisters (dermatitis bullous), acne, hand and foot syndrome (palms of the hands or soles of the feet tingle, become numb, painfully swollen, or red), nappy rash with ulceration in the area surrounding the anus
Maltese: • ulċera tal-ġilda, tip ta' raxx b'tikek ħomor u kultant żoni vjola jew bl-infafet fiċ-ċentru (eritema multiforme), ħorriqija, kundizzjoni tal-ġilda b'infafet mimlija bil-fluwidu (dermatite bl imsiemer), akne, sindrome tal-idejn u s-saqajn (il-pali tal-idejn jew il-qigħan tas-saqajn inemnmu, titlef is-sensazzjoni fihom, jintefħu b'mod li jweġġa', jew jiħmaru), raxx minn ħrieqi b'ulċerazzjoni taż-żona madwar l-anus
English: The total treosulfan dose is 30-42 g/m²; The dose of treosulfan should be adapted to the patient's BSA as follows (see section 5.2):
Maltese: Id-doża ta' treosulfan għandha tiġi adattata għall-BSA tal-pazjent kif ġej (ara sezzjoni 5.2):
English: • Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -4, -3, -2) before stem cell infusion (day 0).
Maltese: • Treosulfan 10 g/m² tal-erja tas-superfiċje tal-ġisem (BSA - body surface area) kuljum bħala infużjoni ġol-vini ta' sagħtejn, mogħti fuq tlett ijiem konsekuttivi (jum -4, -3, -2) qabel linfużjoni taċ-ċelluli staminali (jum 0).
English: Not known Scrotal erythema
Maltese: Mhux magħruf Nekrożi tal-ġilda
English: Common Oedema, pyrexiae, chills
Maltese: Komuni Edema, deni e, tertir
English: Cardiac arrest, cardiac failure, myocardial infarction, pericardial effusion
Maltese: Waqfien tal-qalb, insuffiċjenza talqalb, infart mijokardijaku, effużjoni perikardjali
English: Detailed in vitro studies did not completely exclude potential interactions between high plasma concentrations of treosulfan and CYP3A4, CYP2C19, or P-gp substrates.
Maltese: Studji in vitro ddettaljati ma eskludewx kompletament interazzjonijiet potenzjali bejn konċentrazzjonijiet għolja fil-plażma ta' treosulfan u CYP3A4, CYP2C19 jew substrati ta' P-gp. Għalhekk, prodotti mediċinali b'indiċi terapewtiku dejjaq (eż. digoxin) li huma substrati ta' CYP3A4, CYP2C19 jew P-gp m'għandhomx jingħataw waqt it-trattament bi treosulfan.
English: • itching
Maltese: • għeja
English: • Thiotepa 5 mg/kg twice a day, given as two intravenous infusions over 2-4 hours on day -2 before stem cell infusion (day 0).
Maltese: • Thiotepa 5 mg/kg darbtejn kuljum, mogħti bħala żewġ infużjonijiet ġol-vini fuq perjodu ta' 2-4 sigħat f'jum -2 qabel l-infużjoni taċ-ċelluli staminali (jum 0).
English: Common Dyspnoea, epistaxis
Maltese: Qtugħ ta' nifs, epistassi
English: Trecondi 5 g powder for solution for infusion Colourless type III glass vial, with rubber stopper and aluminium cap containing 5 g of treosulfan.
Maltese: Trecondi 5 g trab għal soluzzjoni għall-infużjoni Kunjett tal-ħġieġ ta' tip III bla kulur, b'tapp tal-lastku u għatu tal-aluminju li fih 5 g ta' treosulfan.
English: Trecondi 1 g powder for solution for infusion Colourless type III glass vial, with rubber stopper and aluminium cap containing 1 g of treosulfan.
Maltese: Trecondi 1 g trab għal soluzzjoni għall-infużjoni Kunjett tal-ħġieġ ta' tip III bla kulur, b'tapp tal-lastku u għatu tal-aluminju li fih 1 g ta' treosulfan.
English: The effect of treosulfan on the pharmacokinetics of fludarabine is not known.
Maltese: L-effett ta' treosulfan fuq il-farmakokinetika ta' fludarabine mhuwiex magħruf.
English: Not known Febrile neutropenia
Maltese: Mhux magħruf Newtropenija bid-deni
English: • Treosulfan 14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0).
Maltese: • Treosulfan 14 g/m² tal-erja tas-superfiċje tal-ġisem (BSA - body surface area) kuljum bħala infużjoni ġol-vini ta' sagħtejn, mogħti fuq tlett ijiem konsekuttivi (jum -6, -5, -4) qabel linfużjoni taċ-ċelluli staminali (jum 0).
English: Analyses of EFS at 2 years for various pre-defined subgroups (donor type, risk group, disease, age group, HCT-CI score, remission status at study entry, and various combinations of these parameters) were always in favour of the treosulfan regimen (hazard ratio [HR] of FT10 vs. FB2 < 1), with only one exception (risk group I of MDS patients; HR 1.14 [95% CI 0.48, 2.63]).
Maltese: Analiżi tal-EFS wara sentejn għal diversi sottogruppi definiti minn qabel (tip ta' donatur, grupp tarriskju, mard, grupp tal-età, punteġġ HCT-CI, stat ta' remissjoni fid-dħul fl-istudju, u diversi kombinazzjonijiet ta' dawn il-parametri) dejjem kienu favur il-kors ta' treosulfan (proporzjoni ta' periklu [HR] ta' FT10 kontra
English: Adults with malignant disease
Maltese: Adulti b'tumuri mhux malinni
English: Five cases of a second malignancy (myelodysplastic syndrome, acute lymphoblastic leukaemia, Ewing's sarcoma) were reported by other investigators after treosulfan-based conditioning.
Maltese: Ħames każijiet ta' tumur malinn sekondarju (sindrome majelodisplastiku, lewkimja limfoblastika akuta, sarkoma ta' Ewing) ġew irrappurtati minn investigaturi oħra wara kkondizzjonar bbażat fuq treosulfan.
English: Intravenous application should be performed using a safe technique.
Maltese: L-applikazzjoni għal ġol-vini għandha titwettaq permezz ta' teknika sigura.
English: Not known Neutropenic colitis
Maltese: Mhux magħruf Kolite newtropenika
English: • high blood sugar level
Maltese: GĦAMLA KWALITATTIVA
English: Stomatitis/mucositis, diarrhoea, nausea, abdominal pain
Maltese: Stomatite/mukożite, dijarea, dardir, uġigħ addominali
English: • inflammation of the colon, inflammation of anus, upset stomach, inflammation of the lining of the rectum, gastrointestinal pain, constipation
Maltese: • infjammazzjoni tal-musrana l-kbira, infjammazzjoni tal-anus, stonku mqalleb , infjammazzjoni tal-kisja tar-rektum, uġigħ gastrointestinali, stitikezza
English: Elderly
Maltese: Denic
English: • muscle weakness
Maltese: • dgħufija fil-muskoli
English: Number of patients Overall survivala; % (95% CI) 71.3 (63.6,
Maltese: HR 1.14 [CI ta' 95% 0.48, 2.63]).
English: Infections and infestations* Very common Infections (bacterial, viral, fungal)
Maltese: Komuni ħafna Infezzjonijiet (batterjali, virali, fungali)
English: • Thiotepa (intensified regimen5 mg/kg twice a day), given as two intravenous infusions over 2
Maltese: • Thiotepa (kors intensifikat ta' 5 mg/kg darbtejn kuljum), mogħti bħala żewġ infużjonijiet ġolvini fuq perjodu ta' 2-4 sigħat f'jum -2 qabel l-infużjoni taċ-ċelluli staminali (jum 0).
English: Conjunctival haemorrhage, dry eye
Maltese: Komuni ħafna Stomatite/mukożite, dardir
English: Non-cardiac chest pain, oedema pyrexiae
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: • abnormal brain function (encephalopathy), bleeding in the brain, restless, repetitive, or involuntary movements and rapid speech (extrapyramidal disorder), fainting, sensation of tingling, pricking or numbness (paraesthesia)
Maltese: • funzjoni anormali tal-moħħ (enċefalopatija), tnixxija ta' demm fil-moħħ, movimenti minħabba nuqqas ta' kwiet, ripetittivi jew mhux volontarji u titkellem tgħaġġel (disturb ekstrapiramidali), tħossok ħażin, sensazzjoni ta' tnemnim, tingiż jew nuqqas ta' sensazzjoni (parestesija)
English: BATCH NUMBER Batch
Maltese: Valur p b
English: • increased liver enzymes, increased C-reactive protein (a marker of inflammation in the body),
Maltese: • żieda fl-enzimi tal-fwied, żieda fil-proteina C-reattiva (markatur ta' infjammazzjoni fil-ġisem), żieda fil-piż, telf ta' piż
English: Gastrointestinal disorders* Very common Stomatitis/mucositis, diarrhoea, nausea, vomiting, abdominal pain
Maltese: Disturbi gastro-intestinali* Komuni ħafna Stomatite/mukożite, dijarea, dardir, rimettar, uġigħ addominali
English: • less acid than normal in the blood (alkalosis), abnormal blood level of electrolytes, decreased blood level of magnesium
Maltese: • inqas aċidu min-normal fid-demm (alkalożi), livell anormali ta' elettroliti fid-demm, tnaqqis fil livell ta' magnesium fid-demm
English: Conventional dose calculation simply based on BSA results in a significantly higher exposure (AUC) of smaller children and infants with low BSA compared to adolescents or adults.
Maltese: Il-kalkolu tad-doża konvenzjonali bbażata sempliċiment fuq riżultati tal-BSA f'esponiment sinifikament ogħla (AUC) ta' tfal iżgħar u trabi b'BSA baxx meta mqabbla ma' adolexxenti jew adulti.
English: 1 g
Maltese: 9/L
English: Mucositis
Maltese: FARMAĊEWTIKU
English: For testing non-inferiority of treosulfan compared to busulfan.
Maltese: Għall-ittestjar tan-noninferjorità ta' treosulfan meta mqabbel ma' busulfan.
English: Pneumonitis, pleural effusion, pharyngeal or laryngeal inflammation, cough, laryngeal pain, hiccups
Maltese: Pulmonite, effużjoni plewrali, infjammazzjoni tal-farinġi jew tallarinġi, sogħla, uġigħ fil-larinġi, sulluzzu
English: 50 vials (suspension)
Maltese: 50 kunjett (suspensjoni)
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: Stimulant AS03 magħmul minn squalene (10.69 milligramma), DL--tocopherol (11.86 milligramma) u polysorbate 80 (4.86 milligramma)
English: A/Indonesia/05/2005 (H5N1) 3.75 micrograms** * propagated in eggs ** haemagglutinin
Maltese: A/Indonesia/05/2005 (H5N1) 3.75 mikrogramma** * imnissla fil-bajd ** emagglutinina
English: 2 x 25 vials (emulsion)
Maltese: 2 x 25 kunjett (emulsjoni)
English: Split influenza virus inactivated, containing antigen* equivalent to:
Maltese: Virus maqsum, mhux attivat tal-influwenza li jkun fih antiġen* ekwivalenti għal:
English: Invented name Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: suspension: 2.5 ml; emulsion: 2.5 ml
Maltese: 2.5 ml; emulsjoni:
English: Intramuscular use suspension (H5N1): vial (glass); emulsion (adjuvant): vial (glass)
Maltese: Suspensjoni (H5N1): kunjett (ħġieġ); emulsjoni (stimulant): kunjett (ħġieġ)
English: Suspension and emulsion for emulsion for injection
Maltese: Suspensjoni u emulsjoni għallemulsjoni għallinjezzjoni
English: After mixing, 1 dose (0.5 ml) contains:
Maltese: Wara li titħallat, doża waħda (0.5 ml) ikun fiha:
English: EU Number
Maltese: suspensjoni:
English: 16 March 2019
Maltese: 16 ta' Marzu 2019
English: 15 May 2019
Maltese: 15 ta' Mejju 2019
English: Adoption of CMDh position:
Maltese: Adozzjoni tal-pożizzjoni tas-CMDh:
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-pożizzjoni mill-Istati Membri (sottomissjoni tal-varjazzjoni midDetentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq):
English: The joint database drug utilisation final study report submitted by the MAHs, together with the joint PASS (physician survey) final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0010), comply with their obligation to conduct a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor the off-label use of the drug as imposed during the referral under Article 31 of Directive 2001/83/EC for domperidone containing products.
Maltese: Ir-rapport tal-istudju finali dwar l-użu tal-mediċini tad-database konġunt sottomess mill-MAHs, flimkien mar-rapport tal-istudju finali konġunt tal-PASS (stħarriġ tat-tabib) sottomess mill-MAHs bħala proċedura separata (EMEA/H/N/PSR/J/0010), jikkonformaw mal-obbligu tagħhom li jwettqu studju dwar l-użu tal-mediċini sabiex tiġi vvalutata l-effettività tal-miżuri tal-imminimizzar tar-riskju u sabiex jiġi ssorveljat l-użu mhux skont it-tikketta tal-mediċina kif impost matul ir-riferiment skont lArtikolu 31 tad-Direttiva 2001/83/KE għal prodotti li fihom id-domperidone.
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tat-traduzzjonijiet tal-annessi għallpożizzjoni:
English: The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure.
Maltese: L-istudju għandu jiġi mwettaq f'aktar minn Stat Membru wieħed u l-protokoll għandu jiġi sottomess lill-PRAC fi żmien 3 xhur mid-Deċiżjoni tal-Kummissjoni għal din il-proċedura.
English: January 2019 CMDh meeting
Maltese: Laqgħa tas-CMDh ta' Jannar 2019
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint PASS (physician survey) final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0010), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Maltese: Għalhekk, fid-dawl tad-data disponibbli rigward ir-rapport tal-istudju finali dwar l-użu tal-mediċini, flimkien mar-rapport tal-istudju finali konġunt (stħarriġ tat-tabib) tal-PASS sottomess bħala proċedura separata (EMEA/H/N/PSR/J/0010), il-PRAC qies li l-bidliet fil-kundizzjonijiet tal-awtorizzazzjoni għattqegħid fis-suq kienu ġġustifikati.
English: The CMDh agrees with the scientific conclusions made by the PRAC.
Maltese: Is-CMDh jaqbel mal-konklużjonijiet xjentifiċi magħmula mill-PRAC.
English: Annex II Conditions to the Marketing Authorisation(s)
Maltese: Anness II
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Maltese: Abbażi tal-konklużjonijiet xjentifiċi għar-riżultati tal-istudju għall-prodott(i) mediċinali li fih/fihom issustanza attiva domperidone u li hu/huma kkonċernat(i) mir-rapport finali tal-PASS, is-CMDh huwa talfehma li l-bilanċ bejn il-benefiċċji u r-riskji tal-prodott(i) mediċinali msemmi(ja) hawn fuq mhuwiex mibdul skont il-bidliet proposti għall-informazzjoni tal-prodott.
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the scientific conclusions are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC għar-rapport finali tal-PASS impost mingħajr intervent għall-prodott(i) mediċinali li fih/fihom is-sustanza attiva domperidone u li huma kkonċernati mir-rapport finali tal-PASS, il-konklużjonijiet xjentifiċi huma kif ġej:
English: per dose.
Maltese: Perjodu ta'
English: ContentPackage size Withdrawal period
Maltese: Kontenut Daqs talpakkett
English: Live attenuated Aujeszky's Disease Virus, strain NIA3783: ≥ 105.2 CCID50*
Maltese: Fjala waħda ta' 10 dożi u flixkun wieħed għarrikostituzzjoni
English: EU Number Tradename Strength
Maltese: Numru ta' l-UE Isem kummerċjali
English: * CCID50 = the quantity of virus, which infects 50% of the cell cultures inoculated.
Maltese: 10 fjali ta' 10 dożi u 10 fliexken għarrikostituzzjoni
English: Page 1 of 1
Maltese: Paġna 1 minn 1
English: 1.2 Application Form - Annex A
Maltese: 1.2 Formola tal-Applikazzjoni - Anness A
English: EU Number Invented name
Maltese: Numru tal-UE Isem Ivvintat Qawwa Għamla
English: Confidential
Maltese: Kunfidenzjali
English: Strength Pharmaceutical Form Route of Administration
Maltese: Il-pakkett li jmiss mal prodott
English: It may harm them,
Maltese: stejatożi epatika,
English: GMR (%) (90%CI) Test Reference
Maltese: GMR (%) (90% CI) Test Referenza
English: M=Excluded
Maltese: M=Esklużi
English: Parameters Test Reference
Maltese: Test Referenza
English: Croscarmellose sodium Hyprolose
Maltese: Croscarmellose sodium
English: Rare photoallergic dermatitis angioedema
Maltese: Rari dermatite fotoallerġika anġjoedema
English: (see section 4.5).
Maltese: (ara sezzjoni 4.5).
English: - if you are over 65.
Maltese: (aktar minn 65 sena).
English: Emtricitabine is a nucleoside analogue of cytidine.
Maltese: Emtricitabine huwa nucleoside analogue ta' cytidine.
English: -3.3 (-8.3% to 2.7%) patients with HIV-1 RNA < 200 copies/ml
Maltese: -3.3% (-8.3% sa 2.7%) pazjenti b'HIV-1 RNA < 200 kopja/ml
English: Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park Carrigtohill
Maltese: Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolised by CYP3A4 (e.g. cyclosporine, tacrolimus, sirolimus)/Efavirenz
Maltese: Immunosoppressanti metabolizzati minn CYP3A4 (eż., cyclosporine, tacrolimus, sirolimus)/Efavirenz
English: patients with HIV-1 RNA < 50 copies/ml
Maltese: pazjenti b'HIV-1 RNA < 50 kopja/ml
English: Difference between Atripla and original treatment regimen (95%CI)
Maltese: Differenza bejn Atripla u rreġim ta' trattament oriġinali (95%CI)
English: • disturbances of coordination and balance
Maltese: • disturbi tal-koordinazzjoni u tal-bilanċ
English: - anorexia
Maltese: - anoreksja
English: Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Maltese: Tenofovir disoproxil jinqeleb in vivo f'tenofovir, analogue ta' nucleoside monophosphate (nucleotide) ta' adenosine monophosphate.
English: - Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) - Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) - Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Maltese: - Efavirenz huwa inibitur non-nucleoside reverse transcriptase (NNRTI) - Emtricitabine huwa inibitur nucleoside reverse transcriptase (NRTI) - Tenofovir huwa inibitur nucleotide reverse transcriptase (NtRTI)
English: Film-coating Iron oxide black Iron oxide red Macrogol 3350
Maltese: Iron oxide black Iron oxide red
English: EU/1/07/430/001 30 film-coated tablets EU/1/07/430/002 90 (3 bottles of 30) film-coated tablets
Maltese: EU/1/07/430/001 30 pillola miksija b'rita EU/1/07/430/002 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Magnesium stearate (E572) Microcrystalline cellulose (E460) Sodium laurilsulfate
Maltese: Magnesium stearate (E572) Microcrystalline cellulose (E460)
English: PVR (KM): Pure virologic response assessed using the Kaplan Meier (KM) method M: Missing
Maltese: PVR (KM): Rispons viroloġiku pur ivvalutat bil-metodu Kaplan Meier (KM) M: Neqsin
English: Verapamil, Felodipine, Nifedipine and Nicardipine
Maltese: Verapamil, Felodipine, Nifedipine u
English: A risk to the infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi mhux eskluż.
English: These metabolites are essentially inactive against HIV-1.
Maltese: Dawn il-metaboliti huma essenzjalment inattivi kontra HIV-1.
English: The systemic clearance of emtricitabine averaged 307 ml/min.
Maltese: It-tneħħija sistematika ta' emtricitabine kellha medja 307 ml/min.
English: hypokalaemia2
Maltese: ipokalimja2
English: Mitochondrial dysfunction following exposure in utero
Maltese: Funzjoni mitokondrijali ħażina wara esponiment in utero
English: Bristol-Myers Squibb spol.
Maltese: Slovenija Bristol-Myers Squibb spol.
English: Norelgestromin (active metabolite):
Maltese: Norelgestromin (metabolit attiv):
English: Uncommon pancreatitis pancreatitis
Maltese: Mhux komuni pankreatite pankreatite
English: There is limited metabolism of emtricitabine.
Maltese: Hemm ftit metaboliżmu ta' emtricitabine.
English: Atripla contains sodium
Maltese: Atripla fih sodium
English: Efavirenz+lamivudine/zid ovudine (N=243)
Maltese: Efavirenz+ lamivudine/ zidovudine (N=243)
English: Gilead Sciences Tél: + 33 (0) 1 46 09 41 00
Maltese: Tél: + 33 (0) 1 46 09 41 00