FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to onset was 4.1 weeks (any grade) and 8.1 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Maltese: Iż-żmien medjan sal-bidu kien ta' 4.1 ġimgħat (kwalunkwe grad) u 8.1 ġimgħat (Grad ≥ 3) fil-grupp ta' lenvatinib flimkien ma' everolimus.
English: • have a history of abnormal passageways (known as a fistula) between different organs in the body or from an organ to the skin
Maltese: • ikollhom storja medika ta' passaġġi mhux normali (magħrufa bħala fistula) bejn organi differenti fil-ġisem jew minn organu lejn il-ġilda
English: Patients with high ECOG performance status
Maltese: Pazjenti bi stat ta' prestazzjoni ECOG għoli
English: Adverse reactions reported in patients treated with lenvatinib
Maltese: Naqqas id-doża u kompli lenvatinib
English: The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively.
Maltese: Il-maġġoranza tal-każijiet irkupraw jew fiequ wara l-interruzzjoni jew it-tnaqqis tad-doża, li seħħew fi 13.0% u 13.4% tal-pazjenti, rispettivament.
English: Discontinuation due to haemorrhagic events occurred in 3.2% of patients in the lenvatinib plus everolimus-treated group.
Maltese: Twaqqif minħabba avvenimenti emorraġiċi seħħ fi 3.2% tal-pazjenti fil-grupp li kien qed jiġi ttratt b'lenvatinib flimkien ma' everolimus.
English: Limited data are available on patients with a body weight below 60 kg with RCC (see also section 4.8, Other special populations).
Maltese: Dejta limitata hi disponibbli fuq pazjenti b'piż tal-ġisem inqas minn 60 kg b'RCC (ara wkoll sezzjoni 4.8, Popolazzjonijiet speċjali oħra).
English: • Use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
Maltese: • Uża kontraċezzjoni effettiva ħafna waqt li tkun qed tieħu din il-mediċina, u għal mill-inqas xahar wara li tispiċċa l-kura.
English: In patients with severe (Child-Pugh C) hepatic impairment, the recommended starting dose of lenvatinib is 10 mg taken once daily in combination with the dose of everolimus recommended for patients with severe hepatic impairment in the everolimus SmPC.
Maltese: F'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C), id-doża rakkomandata tal-bidu ta' lenvatinib hija ta' 10 mg meħuda darba kuljum flimkien mad-doża ta' everolimus rakkomandata għal pazjenti b'indeboliment sever talfwied fl-SmPC ta' everolimus.
English: In patients with DTC, females had a higher incidence of hypertension (including Grade 3 or 4 hypertension), proteinuria, and PPE, while males had a higher incidence of decreased ejection fraction and gastrointestinal perforation and fistula formation.
Maltese: F'pazjenti b'DTC, in-nisa kellhom inċidenza ogħla ta' pressjoni għolja (li tinkludi pressjoni għolja ta' Grad 3 jew 4), proteinurija, u PPE, filwaqt li l-irġiel kellhom inċidenza ogħla ta' porzjon ta' tfigħ 'il barra mnaqqas u perforazzjoni gastrointestinali u l-formazzjoni ta' fistula.
English: Non-GI fistula
Maltese: Ir-Renju Unit
English: The mean terminal exponential half-life of lenvatinib is approximately 28 hours.
Maltese: Il-medja tal-half-life esponenzjali terminali ta' lenvatinib hi ta' madwar 28 siegħa.
English: • hair loss
Maltese: • infjammazzjoni fil-marrara
English: • underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
Maltese: • tirojde mhux attiva biżżejjed (għeja, żieda fil-piż, stitikezza, tħoss il-bard, ġilda xotta)
English: How long to takeKisplyx You will usually carry on taking this medicine as long as you are getting benefit.
Maltese: Għal kemm żmien għandek tieħu Kisplyx Normalment, inti se tkompli tieħu din il-mediċina sakemm tkun qed tikseb benefiċċju.
English: No adjustment of starting dose of the combination is required on the basis of hepatic function in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża tal-bidu tal-kombinazzjoni mhu meħtieġ abbażi tal-funzjoni tal-fwied f'pazjenti b'indeboliment ħafif (Child-Pugh A) jew moderat (Child-Pugh B) tal-fwied.
English: • mini-stroke
Maltese: • nefħa tar-riġlejn
English: Praluent (alirocumab)
Maltese: Praluent (alirokumab)
English: Further information on Praluent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Praluent.
Maltese: ema.europa.eu/en/medicines/human/EPAR/praluent.
English: It contains the active substance alirocumab.
Maltese: Fih is-sustanza attiva alirokumab.
English: Other information about Praluent
Maltese: Informazzjoni oħra dwar Praluent
English: Praluent received a marketing authorisation valid throughout the EU on 23 September 2015.
Maltese: Praluent ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-23 ta' Settembru 2015.
English: Praluent is available as a solution for injection in a pre-filled syringe or pre-filled pen (75 and 150 mg).
Maltese: Praluent jiġi bħala soluzzjoni għal injezzjoni f'siringa mimlija lesta jew pinna mimlija lesta (75 u 150 mg).
English: In a study involving over 18,000 patients who had established heart disease, less than 10% of patients given Praluent had a cardiovascular event (meaning death, heart attack, stroke, chest pain due to problems with the blood flow to the heart leading to hospitalisation) during the study compared with over 11% of patients given placebo.
Maltese: Fi studju li involva ‘l fuq minn 18,000 pazjent li kienu stabbilixxew mard tal-qalb, inqas minn 10 % talpazjenti li ngħataw Praluent kellhom avveniment kardjovaskulari (li jfisser mewt, attakk tal-qalb, puplesija, uġigħ fis-sider minħabba problemi fil-fluss tad-demm lejn il-qalb li jwassal għal ospitalizzazzjoni) matul l-istudju meta mqabbel ma' aktar minn 11 % tal-pazjenti li ngħataw plaċebo.
English: With regard to safety, the Agency noted an acceptable safety profile.
Maltese: Fir-rigward tas-sigurtà, l-Aġenzija nnotat profil ta' sigurtà aċċettabbli.
English: The active substance in Praluent, alirocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific enzyme called PCSK9.
Maltese: Is-sustanza attiva fi Praluent, l-alirokumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel ma' enzima speċifika msejħa PCSK9.
English: Praluent has been studied in 10 main studies involving over 5,000 adult patients with hypercholesterolaemia (including patients with heterozygous familial disease) and mixed dyslipidaemia.
Maltese: Praluent ġie studjat f'10 studji ewlenin li involvew aktar minn 5,000 pazjent adult b'iperkolesterolemija (inklużi pazjenti b'mard eterożigotiku familjali) u dislipidemija mħallta.
English: The usual starting dose is 75 mg every two weeks, but patients requiring bigger reductions of blood fat levels may start with 150 mg every two weeks or 300 mg every 4 weeks.
Maltese: Id-doża normali tal-bidu hija 75 mg kull ġimagħtejn iżda pazjenti li jeħtieġu tnaqqis akbar fil-livelli ta' xaħam fid-demm jistgħu jibdew b'150 mg kull ġimagħtejn jew 300 mg kull 4 ġimgħat.
English: It is used to reduce fat levels in adults with primary hypercholesterolaemia (high levels of blood cholesterol without an identifiable cause, often resulting from the person's genetic makeup) and mixed dyslipidaemia (abnormal levels of different fats in the blood, including cholesterol).
Maltese: Dan jintuża biex inaqqas il-livelli ta' xaħam fl-adulti b'iperkolesterolemija primarja (livelli għoljin ta' kolesterol fid-demm mingħajr kawża identifikabbli, li spiss tirriżulta mill-kompożizzjoni ġenetika talpersuna ) u dislipidemija mħallta (livelli anormali ta' xaħmijiet differenti fid-demm, inkluż il-kolesterol).
English: These studies showed that when Praluent was given on top of a statin it led to a substantial reduction in blood levels of LDL-cholesterol (between 39 and 62% more than placebo) after 6 months of treatment.
Maltese: Dawn l-istudji wrew li meta Praluent ingħata flimkien ma' statin wassal għal tnaqqis sostanzjali fil-livelli ta' kolesterolLDL fid-demm (bejn 39 u 62 % aktar mill-plaċebo) wara 6 xhur ta' kura.
English: When given on top of standard treatment or on its own, Praluent produced a 24 to 36% greater reduction in blood levels of LDL-cholesterol than ezetimibe.
Maltese: Meta jingħata flimkien malkura standard jew waħdu, Praluent pproduċa tnaqqis ta' 24 sa 36 % ikbar fil-livelli ta' kolesterol-LDL fid-demm minn ezetimibe.
English: What are the risks associated with Praluent?
Maltese: X'inhuma r-riskji assoċjati ma' Praluent?
English: The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, treatment with Praluent led to a significant reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular (affecting the heart and blood vessels) disease.
Maltese: L-Aġenzija nnotat li fl-istudji kollha fil-pazjenti b'iperkolesterolemija primarja u dislipidemija mħallta, inklużi pazjenti fuq id-dożi massimi rakkomandati ta' statini jew dawk intolleranti għalihom, kura bi Praluent wasslet għal tnaqqis importanti fil-livelli tal-kolesterol-LDL, li huwa fattur ta' riskju magħruf għal mard kardjovaskulari (li jaffettwa l-qalb u l-vażijiet).
English: As for all medicines, data on the use of Praluent are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Praluent hija ssorveljata kontinwament.
English: How is Praluent used?
Maltese: Praluent?
English: For the full list of side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u tar-restrizzjonijiet, ara lfuljett ta' tagħrif.
English: Atherosclerotic heart disease
Maltese: Mard tal-qalb aterosklerotiku
English: Side effects reported with Praluent are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Praluent huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The most common side effects leading to treatment discontinuation were local injection site reactions.
Maltese: L-effetti sekondarji l-aktar komuni li wasslu biex titwaqqaf il-kura kienu reazzjonijiet lokali fis-sit tal-injezzjoni.
English: In patients with atherosclerotic heart disease, Praluent reduced the number of cardiovascular events, in particular heart attacks and strokes.
Maltese: F'pazjenti b'mard tal-qalb aterosklerotiku, Praluent naqqas in-numru ta' avvenimenti kardjovaskulari, b'mod partikolari l-attakki tal-qalb u l-puplesiji.
English: It is also used to reduce the risk of heart problems and strokes in patients who have atherosclerotic cardiovascular disease (heart problems such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries).
Maltese: Jintuża wkoll biex jitnaqqas ir-riskju ta' problemi tal-qalb u ta' puplesiji f'pazjenti li għandhom mard aterosklerotiku kardjovaskulari (problemi tal-qalb bħall-attakk tal-qalb, puplesija jew problemi oħra tas-sistema ċirkolatorja kkawżati minn depożiti xaħmija li jinbnew fil-ħitan tal-arterji).
English: These receptors control blood levels of cholesterol, especially LDLcholesterol, by removing it from the bloodstream.
Maltese: Dawn ir-riċetturi jikkontrollaw il-livelli ta' kolesterol fid-demm, b'mod speċjali l-kolesterol-LDL, billi jneħħuh mill-fluss tad-demm.
English: By attaching and blocking PCSK9, Praluent prevents the receptors from being broken down inside cells and therefore increases the number of these receptors on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream.
Maltese: Qabel tinbeda l-kura bi Praluent, għandhom jiġu esklużi kawżi oħrajn ta' eċċess ta' kolesterol u livelli anormali ta' xaħam fid-demm.
English: The most common side effects with Praluent (which may affect up to1 in 10 people) are injection site reactions such as pain and redness, problems affecting the nose and throat such as colds, and itching.
Maltese: L-effetti sekondarji l-aktar komuni bi Praluent (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni bħal uġigħ u ħmura, problemi li jaffettwaw l-imnieħer u lgriżmejn bħal irjiħat, u ħakk.
English: The active substance in Rapiscan, regadenoson, is an A2A adenosine receptor agonist.
Maltese: Is-sustanza attiva f'Rapiscan, ir-regadenoson, hija agonista tar-riċettur adenosin A2A .
English: The full EPAR for Rapiscan can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Rapiscan jinstab fis-sit elettroniku tal-Aġenzija taħt EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rapiscan on 6 September 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Rapiscan valida fl-Unjoni Ewropea kollha fis-6 ta' Settembru 2010.
English: It is given as a 10-second injection of 400 micrograms into a vein immediately followed by an injection of sodium chloride (salt) solution.
Maltese: Huwa jingħata bħala injezzjoni ta' 10 sekondi ta' 400 mikrogramm fil-vina immedjatament segwit minn injezzjoni ta' soluzzjoni tas-sodju kloridu (melħ).
English: This is a summary of the European public assessment report (EPAR) for Rapiscan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rapiscan.
English: The most common side effects with Rapiscan (seen in more than 1 patient in 10) are headache, dizziness, ST segment changes (an abnormal reading on the electrocardiogram or ECG), flushing (reddening of the skin), dyspnoea (difficulty breathing), gastrointestinal (stomach and gut) discomfort and chest pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Rapiscan (li dehru f'iktar minn pazjent 1 minn kull 10) huma uġigħ ta' ras, sturdament, bidliet tal-ST segment (qari mhux normali fuq l-elettrokardjogramm jew l-ECG), fwawar (ħmura tal-ġilda), dispnea (diffikultà biex wieħed jieħu nifs), skumdità gastrointestinali (listonku u l-musrana) u uġigħ fis-sider.
English: Rapiscan is a solution for injection that contains the active substance regadenoson.
Maltese: Rapiscan huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva regadenoson.
English: Other information about Rapiscan:
Maltese: Tagħrif ieħor dwar Rapiscan:
English: In two main studies, around 2,000 adult patients first had a myocardial perfusion imaging scan performed using adenosine (another medicine used as a stress agent) followed by a second scan with either adenosine or Rapiscan.
Maltese: F'żewġ studji ewlenin, madwar 2,000 pazjent adult l-ewwel kellhom sken ta' immaġini ta' perfużjoni mijokardijaka li sar bl-użu ta' adenożina (mediċina oħra użata bħala aġent tal-istress) segwit mit-tieni sken bl-użu ta' adenożina jew Rapiscan.
English: What is the risk associated with Rapiscan?
Maltese: X'inhu r-riskju assoċjat ma' Rapiscan?
English: For the full list of all side effects reported with Rapiscan, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Rapiscan, ara l-fuljett ta' tagħrif.
English: Rapiscan must not be used in patients with slow heart rate unless they have a pacemaker, unstable angina (a type of chest pain that changes in severity) that has not been controlled with treatment, severe hypotension (low blood pressure) or decompensated heart failure (when the heart does not work as well as it should).
Maltese: Rapiscan ma għandux jintuża f'pazjenti b'rata tal-qalb baxxa sakemm ma jkollhomx pacemaker, anġina instabbli (tip ta' uġigħ fis-sider li jinbidel fis-severità) li ma ġiex ikkontrollat b'kura, ipotensjoni severa (pressjoni baxxa tad-demm) jew insuffiċjenza tal-qalb dekompensata (meta l-qalb ma taħdimx tajjeb kif suppost).
English: It is used in a type of heart scan called ‘radionuclide myocardial perfusion imaging' to see the blood flow in the heart muscle.
Maltese: Jintuża f'tip ta' sken tal-qalb imsejjaħ ‘immaġini ta' perfużjoni radjonuklida mijokardijaka' (radionuclide myocardial perfusion imaging) sabiex wieħed jara l-fluss tad-demm fil-muskolu tal-qalb.
English: It is used in adult patients (aged 18 years or over) who are unable to exercise enough for a stress test.
Maltese: Huwa jintuża f'pazjenti adulti (età 18 sena jew aktar) li ma jkunux jistgħu jeżerċitaw biżżejjed għal test tal-istress.
English: A risk management plan has been developed to ensure that Rapiscan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Rapiscan jintuża bl-aktar mod sigur possibbli.
English: What is Rapiscan?
Maltese: X'inhu Rapiscan?
English: Rapiscan is for diagnostic use only.
Maltese: Rapiscan jintuża esklussivament għal użu dijanjostiku.
English: This enables the blood flow in the heart to be seen more easily during myocardial perfusion imaging.
Maltese: Dan jippermetti li l-fluss tad-demm fil-qalb jidher aktar faċilment matul l-immaġini ta' perfużjoni mijokardijaka.
English: The CHMP decided that Rapiscan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Rapiscan huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: They should also stop receiving dipyridamole (a medicine used to prevent blood clots) for at least two days before receiving Rapiscan.
Maltese: Huma għandhom ukoll jieqfu jirċievu dipiridamol (mediċina użata biex tipprevjeni emboli tad-demm) għall-inqas jumejn qabel ma jirċievu Rapiscan.
English: How is Rapiscan used?
Maltese: Kif jaħdem Rapiscan?
English: The patient then undergoes the procedures for radionuclide myocardial perfusion imaging, starting with an injection of a radioactive substance 10 to 20 seconds after the sodium chloride injection.
Maltese: Il-pazjent imbagħad jgħaddi mill-proċeduri għallimmaġini ta' perfużjoni radjonuklida mijokardijaka, li jibdew b'injezzjoni ta' sustanza radjuattiva 10-20
English: Why has Rapiscan been approved?
Maltese: Għaliex ġie approvat Rapiscan?
English: For further information on the use of Rapiscan, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar l-użu ta' Rapiscan, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: What measures are being taken to ensure the safe and effective use of Rapiscan?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effikaċi ta' Rapiscan?
English: 50 micrograms
Maltese: 50 mikrogramma
English: Suspension (AS01B Adjuvant System):
Maltese: Sospensjoni (AS01B Sistema Adjuvant):
English: N GMC (mIU/ml) (95% CI)
Maltese: GMC (mIU/ml) (CI ta' 95%)
English: GlaxoSmithKline Biologicals SA Parc de la Noire Epine 20, Avenue Fleming 1300 Wavre
Maltese: GlaxoSmithKline Biologicals SA Parc de la Noire Epine 20, Avenue Fleming 1300
English: EU/1/18/1272/002
Maltese: EU/1/18/1272/001 EU/1/18/1272/002
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2018
Maltese: AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Marzu 2018
English: This protein is not infectious.
Maltese: Din il-proteina ma tqabbadx infezzjoni.
English: Systemic immunosuppressive medications and immunodeficiency
Maltese: Medikazzjonijiet immunosoppressivi sistemiċi u immunodefiċjenza
English: Powder (gE antigen):
Maltese: Trab (antiġen gE):
English: 1Adverse reactions from spontaneous reporting Reporting of suspected adverse reactions
Maltese: 1Reazzjonijiet avversi minn rapportar spontanju Rappurtar ta' reazzjonijiet avversi suspettati
English: Age group (years)
Maltese: Grupp ta' età (snin)
English: Dioleoyl phosphatidylcholine
Maltese: Dioleoyl phosphatidylcholine Cholesterol
English: Median frequency (Q1; Q3)
Maltese: (Q1; Q3)
English: 10 vials: powder (antigen) 10 vials: suspension (adjuvant)
Maltese: kunjett 1: sospensjoni (adjuvant) 10 kunjetti: trab (antiġen) 10 kunjetti: sospensjoni (adjuvant)
English: Rare hypersensitivity reactions including rash, urticaria, angioedema1
Maltese: Rari reazzjonijiet ta' sensittività eċċessiva inkluż raxx, urtikarja, anġjoedema1
English: Varicella Zoster Virus1 glycoprotein E antigen2,3
Maltese: Virus Variċella Zoster 1 glikoproteina E antiġen2,3
English: Month 38**
Maltese: Xahar 38**
English: § Not statistically significant
Maltese: Mhux statistikament sinifikanti
English: Vaccine efficacy [95% CI]
Maltese: [CI ta' 95 %]
English: The humoral immunogenicity and CMI results are presented in Tables 3 and 4, respectively.
Maltese: Ir-riżultati tal-immunoġeniċità umorali u tas-CMI huma ppreżentati f'Tabelli 3 u 4, rispettivament.
English: o Powder: Sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium phosphate.
Maltese: Sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate, dipotassium phosphate.
English: 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms
Maltese: 2 adjuvantat b'AS01B li fih: estratt tal-pjanta Quillaja saponaria Molina, frazzjoni 21 (QS-21) 50 mikrogramma 3-O-desacyl-4'-monophosphoryl lipidu A (MPL, monophosphoryl lipid) minn Salmonella minnesota
English: The adjuvant effect of AS01B is the result of interactions between MPL and QS-21 formulated in liposomes.
Maltese: AS01B huwa r-riżultat tal-interazzjonijiet bejn MPL u QS-21 fformulati f'lipożomi.
English: - ZOE-50 (Zoster-006): 15,405 adults ≥ 50 years were randomised to receive two doses of either
Maltese: - ZOE-50 (Zoster-006): 15,405 adulti ta' ≥ 50 sena ġew randomizzati biex jirċievu żewġ dożi ta' jew
English: Table 1: Shingrix efficacy against HZ
Maltese: Tabella 1: L-effikaċja ta' Shingrix kontra HZ
English: 1 dose (0.5 ml)
Maltese: Sospensjoni doża 1 (0.5 ml)
English: Excipients: sucrose polysorbate 80 sodium dihydrogen phosphate dihydrate dipotassium phosphate dioleoyl phosphatidylcholine cholesterol sodium chloride disodium phosphate anhydrous potassium dihydrogen phosphate water for injections
Maltese: sucrose polysorbate 80 sodium dihydrogen phosphate dihydrate dipotassium phosphate dioleoyl phosphatidylcholine cholesterol sodium chloride disodium phosphate anhydrous potassium dihydrogen phosphate ilma għall-injezzjonijiet
English: B-1330 Rixensart, Belgium
Maltese: B-1330 Rixensart, il-Belġju
English: Table 2: Shingrix efficacy against PHN
Maltese: Tabella 2: L-effikaċja ta' Shingrix kontra PHN
English: Month 3*
Maltese: Xahar 3*
English: The duration of protection beyond 4 years is currently under investigation.
Maltese: Bħalissa qed tiġi investigata d-durata tal-protezzjoni wara 4 snin.
English: Anti-gE immune response^
Maltese: Rispons immuni kontra gE^
English: 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose;
Maltese: globali/doża; 3.8% sever/doża), majalġja (32.9% globali/doża; 2.9% severa/doża), għeja (32.2% globali/doża; 3.0% severa/doża) u uġigħ ta' ras (26.3% globali/doża; 1.9% sever/doża).
English: Ireland GlaxoSmithKline (Ireland) Ltd
Maltese: GlaxoSmithKline (Cyprus) Ltd
English: The safety profile presented below is based on a pooled analysis of data generated in placebo controlled clinical studies on 5,887 adults 50-69 years of age and 8,758 adults ≥ 70 years of age.
Maltese: Il-profil tas-sigurtà ppreżentat hawn taħt huwa bbażat fuq analiżi miġbura ta' dejta ġġenerata fi studji kliniċi kkontrollati bil-plaċebo fuq 5,887 adult ta' età ta' 50-69 sena u 8,758 adult ta' età ta' ≥ 70 sena.
English: gE-specific CD4[2+] T cell response^
Maltese: rispons taċ-ċellula CD4[2+] T speċifiku għal gE^