FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
Maltese: Madankollu, l-effetti sekondarji li ġejjin jidhru f'bejn pazjent 1 u 10 minn kull 1,000: infezzjonijiet fil-parti tan-nifs (irjiħat) fosthom infjammazzjoni talgriżmejn u s-sinus, infezzjoni fl-apparat urinarju (infezzjoni fl-istrutturi li jġorru l-awrina) fosthom linfezzjoni fil-bużżieqa, anemija (tnaqqis fil-għadd ta' ċelloli ħomor tad-demm), iperkalemija (livelli għoja ta' potassju fid-demm), dipressjoni, insonnja (diffikultà fl-irqad), sinkope (tħossok ħażin), mejt (vertiġini, sens ta' tidwir), bradikardija (taħbit tal-qalb mhux mgħaġġel), ipotensjoni (pressjoni baxxa), dispnea (diffikultà fin-nifs), sogħla, uġigħ addominali (uġigħ fl-istonku), dijarrea, dispepsija (ħruq flistonku), flatulenza (gass), remettar, iperidrożi (għaraq eċċessiv), prurite (ħakk), raxx, mijalġija (uġigħ fil-muskoli), uġigħ fid-dahar, spażmi tal-muskolu, indeboliment renali (problemi fil-kliewi) inkluża linsuffiċjenza renali (insuffiċjenza tal-kliewi), uġigħ fis-sider, astenja (djgħufija) u livelli għola ta' kreatina fid-demm (marker tal-kataboliżmu - diżintegrazzjoni tal-muskoli).
English: The full EPAR for Micardis is available on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Micardis is a medicine that contains the active substance telmisartan.
Maltese: Micardis huwa mediċina li fih s-sustanza attiva telmisartan.
English: Various doses of Micardis were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Maltese: Diversi dożi differenti ta' Micardis tqabblu ma' plaċebo (trattament finta) jew ma' mediċini oħra għall-ipertensjoni (atenolol, lisinopril, enalapril u amlodipina).
English: This summary was last updated in 08-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'05-2012.
English: This is a summary of the European public assessment report (EPAR) for Micardis.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Micardis.
English: For the treatment of essential hypertension, Micardis has been studied in 2,647 patients who took Micardis either alone or in combination with hydrochlorothiazide.
Maltese: Għall-kura tal-ipertensjoni essenzjali, Micardis ġie studjat f'2,647 pazjent li ħadu Micardis waħdu jew inkella flimkien mal-idroklorotijażide.
English: For the treatment of essential hypertension, the usual recommended dose of Micardis is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Maltese: Għall-kura tal-ipertensjoni essenzjali, normalment id-doża rakkomandata ta' Micardis hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw mill-użu ta' doża ta' 20 mg darba kuljum.
English: For the prevention of cardiovascular problems, 80 mg Micardis once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Maltese: Għall-prevenzjoni ta' problemi kardjovaskulari, id-doża ta' 80 mg ta' Micardis darba kuljum ġiet studjata fi studju li involva kważi 26,000 pazjent minn 55 sena 'l fuq li kellhom mard fil-qalb jew flarterji, puplesija, jew kellhom id-diabete u kien f'riskju għoli ta' problemi kardjovaskulari.
English: Why has Micardis been approved?
Maltese: Għaliex ġie approvat Micardis?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: M'huwiex rakkomandat li jintuża waqt l-ewwel tliet xhur tat-tqala.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Maltese: Għall-prevenzjoni ta' problemi kardjovaskulari, id-doża rakkomandata hija ta' 80 mg darba kuljum.
English: What is the risk associated with Micardis?
Maltese: X'inhu r-riskju assoċjat ma' Micardis?
English: Micardis was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Maltese: Micardis tqabbel ma' ramipril (mediċina oħra li tipprevjeni problemi kardjovaskulari), kif ukoll mat-taħlita tażżewġ mediċini.
English: What is Micardis?
Maltese: X'inhu Micardis?
English: Hypotension may be more common in patients receiving Micardis to prevent cardiovascular problems.
Maltese: L-ipotensjoni tista' tkun iżjed komuni f'pazjenti li jkunu qed jingħataw Micardis għall-prevenzjoni ta' problemi kardjovaskulari.
English: The active substance in Micardis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Micardis, telmisartan, hija tip ta' “antagonista tar-riċetturi tal-anġjotensina
English: If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Maltese: Jekk il-pressjoni tad-demm mixtieqa ma tintlaħaqx, id-doża tista' tiżdied għal 80 mg, jew inkella tista' tiżdied mediċina oħra għall-ipertensjoni, bħal idroklorotijażide (hydrochlorothiazide).
English: How has Micardis been studied?
Maltese: Kif ġie studjat Micardis?
English: Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day.
Maltese: Ilpazjenti li jbatu minn indeboliment serju fil-kliewi għandhom jingħataw doża aktar baxxa ta' 20 mg darba kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Micardis on 16 December 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Micardis valida fl-Unjoni Ewropea kollha fis-16 ta' Diċmebru 1998.
English: For the full list of all side effects reported with Micardis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Micardis, ara l-fuljett ta' tagħrif.
English: Side effects with Micardis are not common.
Maltese: L-effetti sekondarji b'Micardis m'humiex komuni.
English: Micardis must not be used in people who have severe liver problems or bile problems.
Maltese: Micardis ma għandux jintuża f'persuni li jkollhom problemi gravi fil-fwied jew problemi biljari.
English: In the prevention of cardiovascular problems, Micardis had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Maltese: Għall-prevenzjoni ta' problemi kardjovaskulari, Micardis kellu effett simili għal ramipril, b'madwar 17% tal-pazjenti mietu, iddaħlu l-isptar minħabba problemi kardjovaskulari, jew kellhom attakk tal-qalb jew puplesija.
English: The CHMP decided that Micardis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Micardis huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In the treatment of essential hypertension, Micardis was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Maltese: Għall-kura tal-ipertensjoni essenzjali, Micardis irriżulta aktar effikaċi mill-plaċebo biex inaqqas ilpressjoni tad-demm dijastolika u kellu effetti simili għal mediċini oħra għall-ipertensjoni.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Maltese: Il-pazjenti li jbatu minn indeboliment ħafif jew moderat fil-fwied ma għandhomx jingħataw dożi għola minn 40 mg kuljum.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Maltese: Dan jippermetti wkoll lill-qalb biex tippompja d-demm b'mod iktar faċli, sistema li tista' tgħin biex tnaqqas ir-riskju ta' problemi kardjovaskolari fil-futur.
English: How does Micardis work?
Maltese: Għal xiex jintuża Micardis?
English: Micardis is used to treat essential hypertension (high blood pressure) in adults.
Maltese: Micardis jintuża fit-trattament tal-ipertensjoni essenzjali (pressjoni tad-demm għolja) fl-adulti. ‘Essenzjali' tfisser li l-ipertensjoni ma jkollhiex kawża evidenti.
English: It is available as capsules (50 and 150 mg).
Maltese: Jiġi f'kapsuli (50 u 150 mg).
English: Cystagon mercaptamine
Maltese: Cystagon merkaptamina
English: The full EPAR for Cystagon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The maximum dose should never exceed 1.95 g per m2 per day.
Maltese: Id-doża massima ma għandhiex taqbeż il-1.95 g per m2 kuljum.
English: This summary was last updated in 07-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 07-2013.
English: Cystagon has been investigated in three main studies including 234 patients over a 12-year period.
Maltese: Cystagon ġie investigat fi tliet studji ewlenin li fihom ħadu sehem 234 pazjent fuq perjodu ta' 12-il sena.
English: This is a summary of the European public assessment report (EPAR) for Cystagon.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cystagon.
English: The most common side effects with Cystagon (seen in more than 1 patient in 10) are loss of appetite, vomiting, nausea (feeling sick), diarrhoea, lethargy (lack of energy) and pyrexia (fever).
Maltese: L-effetti sekondarji l-aktar komuni b'Cystagon (li dehru f'aktar minn pazjent 1 minn 10) huma telf ta' aptit, remettar, nawżja (dardir), dijarrea, letarġija (nuqqas ta' enerġija) u piressija (deni).
English: Cystagon is a medicine containing the active substance mercaptamine (also known as cysteamine).
Maltese: Cystagon huwa mediċina li fiha s-sustanza attiva merkaptamina (magħrufa wkoll bħala sisteamina).
English: For patients over the age of 12 and over 50 kg in weight, the recommended daily dose is 2 g divided into 4 doses.
Maltese: Għallpazjenti ta' iktar minn 12-il sena u li jiżnu iktar minn 50 kg, id-doża rakkomandata hi ta' 2g kuljum, maqsuma f'4 dożi.
English: The active substance in Cystagon, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Maltese: Is-sustanza attiva f'Cystagon, il-merkaptamina, tirreaġixxi mas-sistin biex tifforma aċidu ammoniku ieħor, imsejjaħ sisteina, u kompost imsejjaħ melħ sisteina-sisteamina.
English: What is the risk associated with Cystagon?
Maltese: X'inhu r-riskju assoċjat ma' Cystagon?
English: What is Cystagon?
Maltese: X'inhu Cystagon?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cystagon on 23 June 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Cystagon valida fl-Unjoni Ewropea kollha fit-23 ta' Ġunju 1997.
English: Cystagon is used in patients who have nephropathic (kidney) cystinosis.
Maltese: Cystagon jintuża f'pazjenti li għandhom is-sistonożi nefropatika (fil-kliewi).
English: Starting doses should be one quarter to one sixth of the final expected doses.
Maltese: Id-dożi tal-bidu għandhom ikun bejn kwart u wieħed minn kull sitta tad-dożi finali.
English: Why has Cystagon been approved?
Maltese: Għaliex ġie approvat Cystagon?
English: How has Cystagon been studied?
Maltese: Kif ġie studjat Cystagon?
English: Because the disease is very serious, it was not possible for ethical reasons to compare Cystagon directly to placebo (a dummy treatment).
Maltese: Billi l-marda hi sejra ħafna, għal raġunijiet etiċi ma kienx possibbli li Cystagon jitqabbel direttament ma' plaċebo (trattament finta).
English: Cystinosis is a rare inherited disease in which excess amounts of cystine, an amino acid naturally found in the body, build up within cells, especially in the kidneys and the eyes, damaging them.
Maltese: Is-sistonożi hija marda ereditarja rari li fiha ammonti eċċessivi ta' sistin, aċidu amminiku misjub b'mod naturali fil-ġisem, jinġema' fiċ-ċelloli, speċjalment fil-kliewi u l-għajnejn, u jagħmlilhom il-ħsara.
English: For children up to the age of 12 years, the recommended daily dose is calculated according to body surface area (which is calculated from the patient's height and weight), as 1.30 g per m2 divided into 4 doses.
Maltese: Fit-tfal ta' 12-il sena jew inqas, id-doża rakkomandata hija kkalkulata skont l-erja tas-superfiċje talġisem (ikkalkulata skont it-tul u l-piż tal-pazjent), bħala 1.30 g/m2 kuljum maqsuma f'4 dożi.
English: The CHMP decided that Cystagon's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Cystagon huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The comparison was done instead with a group of patients who had been treated with a dummy treatment as part of another, unrelated trial.
Maltese: Il-paragun minflok sar ma grupp ta' pazjenti li kienu ġew trattati bi trattament finta bħala parti minn studju ieħor li m'huwiex relatat.
English: 7.5 micrograms**
Maltese: 7.5 mikrogrammi**
English: CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Maltese: CZ-281 63 Kostelec nad Cernymi lesy Ir-Repubblika Ċeka
English: Preferred MedDRA Term
Maltese: Terminu MedDRA Preferut
English: Day 181
Maltese: Jum 181
English: Frequency1
Maltese: Frekwenza1
English: Immune response against A/California/07/2009(H1N1)v
Maltese: Rispons immuni kontra A/California/07/2009(H1N1)v
English: Frequency 9 - 17 years 3 - 8 years 6 - 35 months
Maltese: Frekwenza 9 sa 17-il sena 3 sa 8 snin 6 - 35 xaħar
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01
Maltese: Vaċċini kontra l-influwenza, Kodiċi ATC J07BB01
English: Day 361
Maltese: Jum 361
English: 3 to 8 years
Maltese: 3 sa 8-il sena
English: 2nd Dose
Maltese: 2ni Doża
English: Uferstrasse 15
Maltese: Baxter AG Uferstrasse 15
English: Anaphylactic reaction*, Hypersensitivity*
Maltese: Reazzjoni anafilattika*, Sensittività eċċessiva*
English: ADR frequency is based upon the following scale: Very Common (≥ 1/10); Common (≥ 1/100< 1/10), Uncommon (≥ 1/1,000 - < 1/100), Rare (≥ 1/10,000 - < 1/1,000), Very Rare (< 1/10,000)
Maltese: Komuni Ħafna (≥ 1/10); Komuni (≥ 1/100 - < 1/10), Mhux Komuni (≥ 1/1,000 - < 1/100), Rari (≥ 1/10,000 - < 1/1,000), Rari Ħafna
English: 12 to 35 months
Maltese: 12 sa 35 xahar
English: Neuralgia, paraesthesia, transient thrombocytopenia.
Maltese: Newralġja, paraesteżija, tromboċitopenja temporanja.
English: SRH Assay
Maltese: Assaġġ SRH
English: In such cases, the Western Blot method is negative.
Maltese: F'każijiet bħal dawn, il-metodu ta' Western Blot ta' riżultati negattivi.
English: • neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
Maltese: • Disturbi newroloġiċi bħal enċefalomajelite (infjammazzjoni tas-sistema nervuża ċentrali), newrite (infjammazzjoni tan-nervi) u tip ta' paralisi magħrufa bħala s-Sindromu Guillain-Barré
English: * MN titre ≥ 1:40 ** > 4-fold increase in MN titre *** geometric mean increase
Maltese: * MN titre ≥ 1:40 ** > żieda 4 darbiet fl-MN titre *** żieda medja ġeometrika
English: The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
Maltese: Is-sustanzi l-oħra huma: trometamol, sodium chloride, ilma għall-injezzjonijiet, polysorbate 80.
English: Clinical Adverse Reactions (H1N1)v Studies System Organ Class (SOC)
Maltese: Kliniċi (H1N1)v Klassi tal-Organu tas-Sistema (SOC)
English: Uncommon:
Maltese: Rari ħafna:
English: It should be noted that the adverse reactions may be intensified.
Maltese: Għandu jkun innotat li r-reazzjonijiet avversi jistgħu jkunu intensifikati.
English: Pandemic Observational Study with Celvapan (H1N1)v
Maltese: Studju ta' Osservazzjoni Pandemika b'Celvapan (H1N1)v
English: Crude vaccine effectiveness of one dose of pandemic vaccine among children was 100% (95%
Maltese: L-effettività crude tat-tilqima ta' doża ta' tilqima kontra l-influwenza pandemika fost it-tfal kienet ta' 100% (95% CI: 70-100%).
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest
Maltese: • Reazzjonijiet avversi li għandhom jingħataw prijorita biex jiġu rapportati, i.e. reazzjonijiet avversi fatali u ta' periklu għall-ħajja, reazzjonijiet avversi severi mhux mistennija, reazzjonijiet avversi ta' interess speċjali (AESI).
English: Seronegative subjects at baseline (≤ 4mm2)
Maltese: Persuni seronegattivi fil-linja bażi (≤ 4mm2)
English: Pandemic vaccine effectiveness against the medically-attended influenza like illness (ILI) with laboratory-confirmation as A(H1N1)v, was assessed for the vaccination campaign in Jersey 2009/2010 in a case control study (test-negative design).
Maltese: L-effettività tat-tilqima kontra l-influwenza pandemika kontra marda qisha influwenza (ILI) medically-attended, b'konferma tal-laboratorju bħala A(H1N1)v, ġiet evalwata għall-kampanja ta' tilqim f'Jersey fl-2009/2010 fi studju tat-tip case control (test-negative design).
English: Children and adolescents aged 6 months to 17 years of age:
Maltese: Tfal u adolexxenti bejn 6 xhur sa 17-il sena:
English: 6 to 11 months
Maltese: 6 sa 11-il xahar
English: 1st Dose
Maltese: 1el Doża
English: Antibody persistence
Maltese: Persistenza tal-antikorpi
English: 1st
Maltese: 1el
English: Vasculitis with transient renal involvement.
Maltese: Vaskulite b'involviment renali temporanju.
English: • Safety and immunogenicity data in special risk groups (immunocompromised and
Maltese: • Dejta dwar is-sigurtà u l-immunoġeniċità fi gruppi f'riskju speċjali (immunokompromessi u morda b'mod kroniku)
English: Younger children 6 months to 9 years received Celvapan, while older children from 9 to 18 years of age received an adjuvanted split pandemic vaccine.
Maltese: Tfal ta' età iżgħar ta' 6 xhur sa 9 snin irċivew Celvapan, waqt li tfal akbar minn 9 sa 18-il sena rċivew tilqima maqsuma adjuvanted kontra l-influwenza pandemika.
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Maltese: Pakkett wieħed ta' 20 kunjett b'ħafna dożi (ħġieġ ta' Tip I) ta' 5 ml ta' suspensjoni (10 dożi x 0.5 ml)
English: *Such reactions have been manifested by respiratory distress, hypotension, tachycardia, tachypnea, cyanosis, pyrexia, flushing, angioedema, and urticaria Musculoskeletal and connective tissue disorders:
Maltese: Anġjoedema *Dawn ir-reazzjonijiet dehru permezz ta' problemi respiratorji, pressjoni baxxa, takikardija, takipnea, ċijanosi, deni, fwawar, anġjoedema, u urtikarja
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, HTLV-1.
Maltese: Wara t-tilqim kontra l-influwenza jistgħu joħorġu riżultati pożittivi foloz f'testijiet seroloġiċi li jużaw il-metodu ELISA biex jirrilevaw antikorpi kontra l-virus ta' immunodefiċjenza tal-bniedem -1 (HIV1), virus ta' epatite Ċ u speċjalment l-HTLV-1.
English: Trivalent seasonal influenza vaccines
Maltese: Tilqim trivalenti kontra influwenza staġjonali
English: Pharyngolaryngeal pain
Maltese: Uġigħ faringolarinġeali
English: From clinical studies limited immunogenicity and safety data are available for Celvapan (H1N1)v in healthy adult and older subjects and in children (see section 4.4, 4.8, and 5.1).
Maltese: Minn studji kliniċi limitati, dejta dwar is-sigurtà u l-immunogenicità hi disponibbli għal Celvapan (H1N1)v f'persuni adulti u f'persuni akbar fl-età b'saħħithom u fit-tfal (ara sezzjoni 4.4, 4.8, u 5.1).
English: See section 6.5 for the number of doses per vial.
Maltese: Ara sezzjoni 6.5 għan-numru ta' dożi f'kull kunjett.
English: 21 Days After nd
Maltese: 21 Jum Wara
English: Common Common
Maltese: Komuni Komuni
English: A-2304 Orth/Donau Austria
Maltese: A-2304
English: Other medicines and Celvapan
Maltese: Mediċini oħra u Celvapan
English: However, some differences in frequency and type of side effects were observed.
Maltese: Madankollu, xi differenzi fil-frekwenza u t-tip ta' effetti sekondarji kienu osservati.
English: Celvapan (H1N1)v to healthy children aged 6 months to 17 years.
Maltese: Celvapan (H1N1)v lil tfal b'saħħithom li kellhom minn 6 xhur sa 17-il sena.
English: Children and adolescents aged 5 to 17 years:
Maltese: Tfal u adolexxenti minn 5 sa 17-il sena:
English: METABOLISM AND NUTRITION DISORDERS
Maltese: FIL-METABOLIŻMU U N-NUTRIZZJONI
English: The immunogenicity of the vaccine containing 7.5 μg non-adjuvanted HA derived from strain A/California/07/2009 (H1N1)v has been evaluated in clinical studies in adults aged 18 years and older (N = 200), in children and adolescents aged 3 to 17 years (N = 102), and in infants and young children aged 6 to 35 months (N = 68) following a 0, 21 day schedule.
Maltese: L-immunoġeniċità tal-tilqima li fiha 7.5 μg non-adjuvanted HA derivat minn razza A/California/07/2009 (H1N1)v, ġiet evalwata fi studji kliniċi li saru fuq persuni adulti li kellhom 18-il sena u aktar (N = 200), fi tfal u adolexxenti li kellhom minn 3 sa 17-il sena (N = 102), u fi trabi u tfal żgħar li kellhom minn 6 sa 35 xahar (N = 68) wara skeda ta' 0, 21 jum.
English: Following a 12-month booster vaccination with a licensed trivalent virosomal influenza vaccine for the 2010/2011 Northern hemisphere influenza season, seroprotection rates, seroconversion rates and serconversion factors (compared to pre-booster antibody levels) for the H1N1 component as measured by SRH and MN assays were as follows:
Maltese: Wara tilqima booster ta' 12-il xahar b'vaċċin virosomali trivalenti tal-influwenza għall-istaġun tal-influwenza fl-emisfera tat-Tramuntana 2010/2011, ir-rati ta' seroprotezzjoni, ir-rati ta' serokonverżjoni u l-fatturi ta' serokonverżjoni (meta mqabbla mal-livelli ta' antikorpi qabel il-booster) għall-komponent H1N1 kif imkejla b'assaġġi SRH u MH, kienu kif ġej:
English: Hypersensitivity reactions, including anaphylaxis, have been reported following CELVAPAN vaccination (see section 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva, li jinkludu anafilassi, kienu rrappurtati wara tilqima b'Celvapan (ara sezzjoni 4.8).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/.
English: CELVAPAN suspension for injection Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Maltese: CELVAPAN suspensjoni għall-injezzjoni Vaċċin kontra l-influwenza (H1N1)v (virijon sħiħ, derivat minn ċelluli Vero, inattivat)