FrancophonIA/ELRC3.0 huggingface dataset:
English: To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a beam, accelerated by an electric field, deflected in a magnetic field, and finally detected.
Maltese: Sabiex jiġi analizzat il-kampjun ta' gass ta' dijossidu karboniku separat, il-molekuli jridu jiġi ijoniżati, magħmula f'raġġ, aċċelerati f'medda elettrika, milwija f'medda manjetika, u fl-aħħar intraċċata.
English: Pour the contents into a drinking glass.
Maltese: Ferragħ il kontenut f'tazza.
English: The breath samples, collected in 10 ml glass- or plastic sample tubes, are analysed by isotope ratio mass spectrometry (IRMS).
Maltese: Il-kampjuni tan-nifs, miġbura f'tubi għal kampjuni, ta' 10 ml, tal-ħġieġ jew tal-plastik, jiġu analizzati permezz ta' isotope ratio mass spectrometry (IRMS).
English: Security access:
Maltese: Aċċess ta' sigurtà:
English: For Mass Spectrometry
Maltese: Għal spettrometrija tal-massa
English: Jar contains 75 mg 13C-urea
Maltese: Vażett wieħed fih 75 mg 13C-urea
English: In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test achieved in a clinical trial on 168 patients from the age of 3 to 11, a sensitivity of 98.4 % [90 %-CI: ≥ 93.9 %], and a specificity of 98.1 % [90 %-CI: ≥ 95.1 %].
Maltese: B'paragun ma' dijanjotiċi biottiċi ta' infezzjoni b'Helicobacter pylori, it-test tan-nifs, waqt provi kliniċi li saru fuq 168 pazjent bejn l-etajiet ta' 3 snin u 11-il sena, kellu sensittività ta' 98.4%
English: Page of labels and sticker Barcode for data sheet for patient documentation Seal-Sticker
Maltese: Barcode għal fuljett ta' l-informazzjoni għad-dokumentazzjoni tal-pazjent
English: This enables measurement of the 13C/12C-ratio at any CO2 concentration above 1 %.
Maltese: Dan jippermetti l-kejl tal-proporzjon 13C/12C f' kull konċentrazzjoni 'l fuq minn 1%.
English: Helicobacter Test INFAI 75 mg powder for oral solution 13C-urea
Maltese: Helicobacter Test INFAI 75 mg trab ta' 13C urea għal soluzzjoni orali
English: The test should be carried out after having fasted 6 hours before application, preferably overnight.
Maltese: Trid tkun sajjem għal 6 sigħat qabel it-teħid, preferibilment wara lejl.
English: A test set contains 50 jars with the additional components:
Maltese: Sett tat-testijiet jikkonsisti minn 50 vażett bil-komponenti addizzjonali li ġejjin:
English: Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: - adults, - adolescents, who are likely to have peptic ulcer disease.
Maltese: Helicobacter Test INFAI jista' jintuża għal dijanjosi in vivo ta' infezzjoni b'Helicobacter pylori flistonku u l-imsaren f': - adulti, - adoloxxenti, li jista' jkollhom mard ta' l-ulċera fl-istonku.
English: Only in Helicobacter pylori-positive patients does the administration of 75 mg labelled urea lead to a significant increase of 13CO2 in the breath sample within the first 30 minutes.
Maltese: Huwa biss f'pazjenti li għandhom Helicobacter pylori li t-teħid ta' 75 mg urea ttikkettata jwassal għal żieda sinifikanti ta' 13CO2 fil-kampjun tan-nifs fi żmien nofs siegħa.
English: You have already been determined as being infected with Helicobacter pylori and have been taking medication aimed to clear up the infection.
Maltese: Inti diġà ġejt determinat li int infettat b'Helicobacter pylori u qed tieħu mediċini mmirati sabiex tfejjaq l-infezzjoni.
English: Only in Helicobacter pylori- positive patients does the administration of 45 mg labelled urea lead to a significant increase of 13CO2 in the breath sample within the first 30 minutes.
Maltese: Huwa biss f'pazjenti li għandhom Helicobacter pylori li t-teħid ta' 45 mg urea ttikkettata jwassal għal żieda sinifikanti ta' 13CO2 fil-kampjun tan-nifs fi żmien nofs siegħa.
English: Children from the age of 3 to 11 must take the contents of 1 jar with 45 mg.
Maltese: Tfal mill-etajiet ta' 3 sa 11-il sena jieħdu l-kontenut ta' vażett b' 45 mg.
English: Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX For the amount of 45 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
Maltese: Għall-ammont ta'45 mg 13C-urea, mogħti għal kull unità fil-perkors tat-test tan-nifs, l-ebda attività farmakodinamika m'hija deskritta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON, PACK SIZE 50
Maltese: KARTUNA TA' BARRA, DAQS TAL-PAKKETT 50
English: CLINIPAC BASIC
Maltese: CLINIPAC
English: Content of the test kit:
Maltese: Kontenut tal-kitt tas-sett:
English: The following are suitable test meals:
Maltese: Analiżi replikati multipli:
English: Then the patient must drink the recommended test meal (100 ml 100 % orange juice).
Maltese: Ser tiġi mitlub tixrob l-ikla rakkomandata tat-test (100 ml ta' 100 % meraq tal-larinġ).
English: [95 %-CI: 94.17 %-103.63 %].
Maltese: ≥93.9%], u speċifiċità ta' 98.1% [90%-CI: ≥ 95.
English: For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
Maltese: Għall-ammont ta' 75 mg 13C-urea, mogħti għal kull unità fil-perkors tat-test tan-nifs, l-ebda attività farmakodinamika m'hija deskritta.
English: 2 Breath bags:
Maltese: Boroż tan-nifs:
English: Storing of operating parameters and of results under security access to avoid later manipulation
Maltese: Il-ħażna tal-parametri tal-operat u tar-riżultati taħt aċċess ta' sigurtà biex tiġi evitata manipulazzjoni iktar tard
English: This ensures the high accuracy of this system, as calculation of the isotopic content in carbon dioxide is done with respect to an independent standard.
Maltese: Dan jiżgura l-preċiżjoni għolja ta' din is-sistema, għax il kalkulazzjoni tal-kontenut isotopiku tal-carbon dioxide issir fir-rigward ta' standard indipendenti.
English: Analysis of breath samples and testing specification for laboratories for infrared analyzer or mass spectrometry (IRMS)
Maltese: Analiżi ta' kampjuni tan-nifs u speċifikazzjoni ta' l-ittestjar għal-laboratorji għal analizzatur infrared jew spettrometrija tal-piż (IRMS)
English: Helicobacter Test INFAI 75 mg powder for oral solution
Maltese: Helicobacter Test INFAI 75 mg trab għal soluzzjoni orali
English: None
Maltese: ISEM
English: Now 200 ml of 100 % orange juice or 1 g citric acid in 200 ml water must be drunk by the patient without delay.
Maltese: Issa 200 ml ta' 100 % meraq tal-larinġ jew 1 g ta' aċidu ċitriku f' 200 ml ilma għandu jinxtorob mingħajr dewmien.
English: containing 75 mg 13C-urea powder for oral solution 2 Data sheet for patient documentation 3 Package leaflet
Maltese: Vażett 1 fih 75 mg trab ta' 13C-urea għal soluzzjoni orali 2 boroż tan-nifs għal kampjuni tan-nifs Strô li jitgħawweġ
English: The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test
Maltese: L-analiżi tal-proporzjoni 13C/12C-ratio ta' dijossidu karboniku fin-nifs jagħmel parti integrali mis-sett dijanjostiku Helicobacter Test INFAI.
English: 1 jar containing 45 mg 13C-urea powder for oral solution
Maltese: Vażett 1 fih 45 mg trab ta' 13C-urea għal soluzzjoni orali
English: 94.05 %-99.72 %], and a specificity range from 96.7 % to 100 %.
Maltese: 72 %], u medda ta' speċifiċità minn 96.7 % sa 100%.[95 %-CI:
English: In the absence of bacterial urease, the whole amount of the administered urea after absorption from the gastrointestinal tract will be metabolised like the endogenous urea.
Maltese: Fin-nuqqas ta' urease batteriku, l-ammont sħiħ ta' l-urea amministrat wara assorbiment mill-apparat ta' l-istonku u ta' l-imsaren għandu jiġi metabolizzat bħal urea endoġenu.
English: Any increase in 13CO2 will be measured by isotopic analysis.
Maltese: Kull żieda f' 13CO2 għandu jiġi mkejjel b'analiżi isotopika.
English: From there it is transported as bicarbonate into the lung and liberated as 13CO2 with the exhaled air.
Maltese: Minn hemm jiġi trasportat bħala bikarbonat filpulmun u liberat bħala 13CO2 fl-arja mitfugħa'l barra.
English: Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 13C-urea
Maltese: Helicobacter Test INFAI għal tfal bejn l-etajiet ta' 3 snin sa 11-il sena 45 mg trab ta' 13C urea għal soluzzjoni orali
English: Helicobacter Test INFAI for children of the age 3-11 is a white, crystalline powder for oral solution.
Maltese: Helicobacter Test INFAI għal tfal li jkollhom 3-11-il sena hu trab abjad u kristallin għal soluzzjoni orali.
English: • The straw and the breath bag labelled “sampling time: 00-minute-value” are taken from the test set.
Maltese: • L-l-istrô u t-tubi tal-kampjuni bit-tikketta “Ħin ta' kampjunar: 00-minuti-valur” jittieħdu mis-sett tat-test.
English: These samples will be analysed to measure the “normal” amount of carbon-13 content in the carbon dioxide in your breath.
Maltese: “normali” li jkun hemm ta' carbon-13 fid-Dijossidu Karboniku fin-nifs tiegħek.
English: Both groups of medicines could influence the results of the Helicobacter Test INFAI for children of the age 3-11.
Maltese: Iż-żewġ gruppi ta' mediċini jistgħu jaffetwaw ir-riżultati ta' Helicobacter Test INFAI għal tfal li jkollhom 3-11-il sena.
English: The package must be sent to a qualified laboratory for analysis.
Maltese: Il-pakkett għandu jintbagħat f'laboratorju kkwalifikat għal analiżi.
English: The modulated infrared beams then enter the infrared detectors, which are double layer transmission detectors with a front, and a rear chamber each filled with one of the isotopicly pure gases (13CO2 or 12CO2, respectively) to be measured.
Maltese: Ir-raġġi infra-red immodulati mbagħad jidħlu fl-intraċċaturi infra-red, li huma intraċċaturi ta' trasmissjoni f'żewġ saffi b'kompartament fuq quddiem u ieħor fuq wara, li kull wieħed minnhom huwa mimli b'gassijiet isotopikament puri (13CO2 jew 12CO2, rispettivament) li jridu jiġi mkejla.
English: Jar (10 ml volume, polystyrene with polyethylene snap cap) containing 75 mg 13C-urea powder for oral solution
Maltese: Vażett (volum ta' 10 ml, tap li jinqasam tal-polystyrene ma' polyethylene) li jkun fih 75 mg 13C trab tal-urea għal soluzzjoni li tittieħed mill-ħalq
English: What Helicobacter Test INFAI for children of the age 3-11 is and what it is used for What you need to know before you take Helicobacter Test INFAI for children of the age 3-11 How to take Helicobacter Test INFAI for children of the age 3-11
Maltese: Anke jekk ir-riżultat minn Helicobacter Test INFAI għal tfal li jkollhom 3-11-il sena huwa pożittiv, aktar testijiet għandhom mnejn ikunu meħtieġa qabel ma jkun jista' jinbeda t-trattament għallinfezzjoni minn Helicobacter pylori.
English: • the enzyme urease, which stimulate the reduction of urea
Maltese: • l-enzima urease, li tistimula t-tnaqqis tal-urea
English: • Fill the 13C-urea jar to the brim with water for a second and third time and add these contents to the drinking glass (total volume of tap water should be approximately 30 ml).
Maltese: • Imla l-vażett 13C-urea sax-xifer b'ilma għat-tieni u tielet darba u żid il-kontenut ta' dawn fit-tazza (volum totali ta' ilma tal-vit għandu jkun madwar 30 ml).
English: A test set contains 1 jar with the additional components:
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Test jikkonsisti minn vażett 1 bil-komponenti addizzjonali li ġejjin:
English: In consequence there is a temperature fluctuation, which in its turn causes a fluctuating pressure in the front chamber of the infrared detector.
Maltese: hemm bidla fit-temperatura, li tikkaġuna bidla fil-pressjoni fil-kompartament ta' quddiem ta' l intraċċatur infra-red.
English: 1 Jar (10 ml volume, polystyrene with polyethylene snap cap) containing 75 mg 13C-urea powder for oral solution
Maltese: 1 Vażett (volum ta' 10 ml, tap li jinqasam tal-polystyrene ma' polyethylene) li jkun fih 75 mg 13C trab tal-urea għal soluzzjoni li tittieħed mill-ħalq Boroż tan-nifs
English: Labelled sample glass- or plastic- containers for sampling, storing and transporting the breath samples for analysis: Sampling time: 00-minute-value Sampling time: 30-minute-value 3 Bendable straw for collection of the breath samples into the corresponding sample containers 4 Data sheet for patient documentation 5 Package leaflet 6 Page of barcode labels and sticker
Maltese: Tletin minuta wara t-teħid tas-soluzzjoni tat-test, iġbor il-kampjuni ta' 30 minuta-valur li qegħdin fil-boroż tan-nifs li fadal fil pakkett tat-test (Tikketta: “Ħin ta' kampjunar: 30-minuta valur”), kif deskritt fl-istadji 3 u 4.Uża t-tikketti tal-kodiċi żbarrati mmarkati “30-minuta-valur”
English: • 1 g citric acid dissolved in 200 ml water
Maltese: aċidu ċitriku f' 200 ml ilma).
English: Both might interfere with the Helicobacter pylori status.
Maltese: Helicobacter pylori.
English: 5 How to store Helicobacter Test INFAI Contents of the pack and other information
Maltese: Kif taħżen Helicobacter Test INFAI Kontenut tal-pakkett u informazzjoni oħra
English: If the patient vomits during the test procedure, repetition of the test is necessary.
Maltese: Jekk il pazjent jirremetti waqt il-proċedura tat-test, ir-ripetizzjoni tat-test hi meħtieġa.
English: Thirty minutes after administration of the test solution (point 7), collect the 30-minute-value samples in the breath sample container (tube or breath bags) (Label “Sampling time: 30-minutevalue”), as described under steps 3 to 4.
Maltese: Tletin minuta wara t-teħid tas-soluzzjoni tat-test (punt 7), iġbor il-kampjuni ta' 30 minuta-valur li jinsabu fiż-żewġ reċipjenti tal-kampjuni tan-nifs (bit-tikketta: “Ħin ta' kampjunar: 30-minutavalur”), kif deskritt taħt punti 3 u 4.
English: Stability:
Maltese: Stabbilità:
English: How to store Helicobacter Test INFAI
Maltese: Tiħux Helicobacter Test INFAI
English: Other medicines and Helicobacter Test INFAI
Maltese: Mediċini oħra u Helicobacter Test INFAI
English: Package leaflet: Information for the user Helicobacter Test INFAI 75 mg powder for oral solution
Maltese: Informazzjoni għall-utent Helicobacter Test INFAI 75 mg trab għal soluzzjoni orali
English: The breath test concept relies on the administration of a specifically 13C-labelled urea whose metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas.
Maltese: Il-kunċett tat-test tan-nifs huwa msawwar fuq it-teħid mill-ħalq speċifiku ta' urea ttikkettat 13C li l-użu metaboliku tiegħu jiġi sorveljat bil-kejl ta' 13CO2 f'nifs 'l barra.
English: 30 minutes after the test solution has been taken (point 6), the “30-minute-value” samples are collected in both containers, which remain in the pack (labelled “sampling time: 30-minutevalue”) as described under points 2 and 3.
Maltese: Tletin minuta wara t-teħid tas-soluzzjoni tat-test (punt 6), iġbor il-kampjuni ta' 30 minuta-valur fiż-żewġ kontenituri li qegħdin fil-pakkett tat-test (bit-tikketta: “Ħin ta' kampjunar: 30-minutavalur”), kif deskritt taħt punti 2 u 3.
English: Other urease producing bacteria were seldom found in the gastric flora.
Maltese: Huwa rari li nstabu batterji oħrajn fil-flora gastrika li jipproduċu l-urease.
English: How to store Helicobacter Test INFAI for children of the age 3-11
Maltese: Tiħux Helicobacter Test INFAI għal tfal li jkollhom 3-11-il sena
English: 6.3 Shelf-life
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: One jar contains 75 mg of 13C-urea powder.
Maltese: U KWANTITATTIVA Vażett 1 fih 75 mg trab ta' 13C-urea għal.
English: Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX
Maltese: Numru tal-Identifikazzjoni tal-Pazjent Data tat-twelid
English: Because only 45 mg 13C-urea is provided overdose is not to be expected.
Maltese: Minħabba li 45 mg 13C-urea ibiss huwa provdut mhux mistenni li jkun hemm doża eċċessiva..
English: 1 jar containing 75 mg 13C-urea
Maltese: Vażett 1 fih 75 mg trab ta' 13C-urea
English: One jar contains 45 mg of 13C-urea powder.
Maltese: U KWANTITATTIVA Vażett 1 fih 45 mg trab ta' 13C-urea għal.
English: OTHER
Maltese: l
English: Date of birth Barcode
Maltese: Barcode
English: 50 Data sheets for patient documentation 50 Barcode labels and sticker
Maltese: Sett tat-testijiet jikkonsisti minn 50 vażett bil-komponenti addizzjonali li ġejjin
English: A drinking vessel and tap water is required to dissolve the 13C-urea powder.
Maltese: Reċipjent tax-xorb u ilma tal-vit huma meħtieġa sabiex jinħall it-trab 13C-urea.
English: None known.
Maltese: Mhux magħrufa.
English: For performance of the test, 200 ml 100 % orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 13C-urea powder) are necessary.
Maltese: Sabiex jitwettaq it-test 100 ml 100 % meraq tal-larinġ għal pazjenti bejn l-etajiet ta' 3 snin sa 11-il sena (bħala ikla ta' test amministrata minn qabel), kif ukoll ilma tal-vit (biex jinħall it-trab 13C-urea) huwa meħtieġ.
English: The corresponding bar-code label must be put on the data sheet for patient documentation.
Maltese: Id-dejta tal-pazjent għandha tkun dokumentata billi tuża l-folja ta' informazzjoni fornuta.
English: None.
Maltese: JIS.
English: For breath test analysis the individual balancing of the carbon dioxide of the sample to a reference standard gas is essential.
Maltese: Għal analiżi ta' test tan-nifs, l-ibbilanċjar individwali tal-carbon dioxide tal-kampjun ma' gass standard ta' referenza hu essenzjali.
English: You must have fasted for 6 hours before application, preferably overnight.
Maltese: Il-pazjent irid ikun sajjem għal aktar minn 6 siegħat, preferibilment għal lejl sħiħ.
English: 5 How to store Helicobacter Test INFAI for children of the age 3-11 Contents of the pack and other information
Maltese: Kif taħżen Helicobacter Test INFAI għal tfal li jkollhom 3-11-il sena Kontenut tal-pakkett u informazzjoni oħra
English: Then the patient must drink the recommended test meal (200 ml 100 % orange juice or 1 g citric acid in 200 ml water).
Maltese: Ser tiġi mitlub tixrob l-ikla rakkomandata tat-test (200 ml ta' 100 % meraq tal-larinġ jew 1 g ta'
English: Marketing Authorisation Holder: INFAI GmbH
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM
English: 50 jars containing 75 mg 13C-urea powder for oral solution
Maltese: Vażett 1 fih 75 mg trab ta' 13C-urea għal soluzzjoni orali
English: After oral ingestion the labelled urea reaches the gastric mucosa.
Maltese: It-test tan-nifs huwa amministrazzjoni waħdanija.
English: Urease is produced in the stomach only by Helicobacter pylori.
Maltese: Urease jiġi prodott fl-istonku b'Helicobacter pylori biss.
English: Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.
Maltese: Alternattivament, kull laboratorju oġġettivament ikkwalifikat jista' iwettaq kull metodu vvalidat kif suppost.
English: To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon dioxide must be separated from the breath and introduced into the mass spectrometer.
Maltese: L-iffissar tal-proporzjoni 13C/12C fid-dijossidu karboniku 13C/12C fin-nifs b'analiżi spettrometrika tal massa, id-dijossidu karboniku għandu jiġi separat minn nifs u mdaħħal fl-ispettrometru tal-massa.
English: One jar contains 45 mg 13C-urea.
Maltese: Vażett 1 fih 45 mg trab ta' 13C-urea
English: Marketing Authorisation Number:
Maltese: Kategorija farmakoterapewtika:
English: It is recommended to perform the test with the patient being in a resting position.
Maltese: Mhux mistenni li l-proċedura tat-test tkun ta' ħsara waqt it-tqala jew l-irdigħ.
English: C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
Maltese: Għaliex għandek bżonn tieħu Helicobacter Test INFAI?
English: The patient data should be documented using the provided data sheet.
Maltese: Kull pazjent għandu jkun dokumentat skond il-folja ta' informazzjoni provduta.
English: Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e.g. ulcer, autoimmune gastritis and malignancies.
Maltese: Jista' jkun hemm bżonn ta' dijanjosi differenzjali b'metodi endoskopiċi invażivi sabiex jiġi stabbilit jekk hemmx xi kundizzjonijiet oħrajn preżenti eż. ulċeri, gastrite awtoimmunitarji u malinni.
English: Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution
Maltese: Helicobacter Test INFAI 45 għal tfal li jkollhom 3-11-il sena
English: In the presence of Helicobacter pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori.
Maltese: Dan hu partikolarment minnu wara terapija biex tneħħi Helicobacter pylori.
English: You may have a gastric infection caused by a bacterium called Helicobacter pylori.
Maltese: Jista' ikun li jkollok infezzjoni fl-istonku kkawżata minn batterju msejjaħ Helicobacter pylori.
English: There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4.
Maltese: Hemm diversi varjetajiet (imsejħa serotipi) tal-virus dengue u Dengvaxia jipproteġi kontro s-serotipi 1, 2, 3 u 4.
English: Further information on Dengvaxia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
Maltese: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
English: Other information about Dengvaxia
Maltese: Informazzjoni oħra dwar Dengvaxia
English: However, among children aged between 9 and 16 years who had not had previous dengue infection, the risk of severe dengue disease if they later became infected with the virus was higher in people vaccinated compared with those given placebo (estimated at 2 additional cases per 1000 people vaccinated over 5 years).
Maltese: Madankollu, fost it-tfal ta' bejn id-9 snin u s-16-il sena li preċedentement ma kellhomx infezzjoni b'dengue, ir-riskju ta' marda serja b'dengue jekk iktar tard jiġu infettati bil-virus kien ogħla f'nies imlaqqmin meta mqabbla ma' dawk li ngħataw il-plaċebo (stmat għal 2 każijiet addizzjonali kull 1000 persuna mlaqqma tul 5 snin).
English: Overall, among children aged between 9 and 16 years and who had previous dengue infection, there were around 79% fewer cases of dengue disease in children vaccinated with 3 doses of Dengvaxia compared with placebo.
Maltese: B'mod ġenerali, fost it-tfal ta' bejn id-9 snin u s-16-il sena u li preċedentement kellhom infezzjoni b'dengue, kien hemm madwar 79 % inqas każijiet tal-marda dengue fit-tfal imlaqqmin bi 3 dożi ta' Dengvaxia meta mqabbla mal-plaċebo.
English: Dengvaxia contains attenuated (weakened) yellow fever viruses that have been manipulated so that they contain proteins from dengue virus.
Maltese: Dengvaxia fih virusijiet tad-deni l-isfar (imdgħajfa) attenwati li ġew manipulati sabiex ikun fihom proteini mill-virus dengue.
English: The most common side effects with Dengvaxia (which may affect more than 1 in 10 people) are headache, injection site pain, malaise (feeling unwell), muscle pain, weakness and fever.
Maltese: L-effetti sekondarji l-aktar komuni b'Dengvaxia (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, uġigħ fis-sit tal-injezzjoni, telqa (tħossok ma tiflaħx), uġigħ fil-muskoli, dgħjufija u deni.
English: Dengvaxia is effective at reducing the number of cases of dengue disease in people aged between 9 and 45 years who have had the infection in the past.
Maltese: Dengvaxia huwa effettiv biex inaqqas in-numru ta' każijiet tal-marda dengue f'nies ta' bejn id-9 snin u l-45 sena li diġa' kellhom l-infezzjoni fil-passat.
English: Children were given either 3 injections of Dengvaxia or 3 injections of placebo (a dummy vaccine) with 6 months between each injection.
Maltese: It-tfal ingħataw jew 3 injezzjonijiet ta' Dengvaxia jew 3 injezzjonijiet tal-plaċebo (vaċċin finta) b'6 xhur bejn kull injezzjoni.
English: What are the risks associated with Dengvaxia?
Maltese: X'inhuma r-riskji assoċjati ma' Dengvaxia?
English: Why is Dengvaxia authorised in the EU?
Maltese: Għaliex Dengvaxia huwa awtorizzat fl-UE?