FrancophonIA/ELRC3.0 huggingface dataset:
English: Dukoral confers protection specific to Vibrio cholerae serogroup O1.
Maltese: Dukoral joffri protezzjoni speċifika kontra Vibrio cholerae serogrupp O1.
English: Frequency classification: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni
English: Valneva Sweden AB S-105 21 Stockholm Sweden infodukoral@valneva.com
Maltese: Valneva Sweden AB, 105 21 Stokkolma, l-Iżvezja. infodukoral@valneva.com
English: A booster dose elicited an anamnestic response indicative of an immune memory.
Maltese: Doża buster qanqlet respons anamnestiku, indikattiv ta' memorja immunoloġika.
English: − A total of 1.25x1011 bacteria of the following strains:
Maltese: - Numru totali ta' 1,25x1011 batterji ta' dawn ir-razzez:
English: Metabolism and nutrition disorder Rare
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Rari
English: - suspension for oral suspension:
Maltese: - suspensjoni għal suspensjoni orali:
English: Dukoral contains sodium
Maltese: Dukoral fih sodium
English: 3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet.
Maltese: 3 ml ta' suspensjoni fi flixkun u 5.6 g ta' granijiet li jfexfxu f'qartas.
English: Serum vibriocidal antibodies against the bacterial components were seen in 35-55% of vaccinated subjects and antitoxic antibodies in 78-87% of vaccinated subjects.
Maltese: Kien osservat li l-antikorpi vibrijoċidali fis-serum ta' kontra l-komponenti tal-batterji kienu preżenti f'3555% tal-persuni vaċċinati, u l-antikorpi antitossiċi kienu preżenti f'78-87% tal-persuni vaċċinati.
English: Dukoral is available in packs of 1, 2 and 20 doses.
Maltese: Dukoral issibu f'pakketti ta' 1, 2 u 20 doża.
English: Booster dose
Maltese: Doża buster
English: Shake the Dukoral® suspension vial (1 vial = 1 dose).
Maltese: Ħawwad is-suspensjoni Dukoral® tal-vaċċin (flixkun 1 = doża 1).
English: Locally produced secretory IgA antibodies in the intestine probably mediate protective immunity.
Maltese: Huwa probabbli li l-antikorpi tat-tip IgA li jnixxu fl-imsaren huma involuti fl-immunità protettiva.
English: Valneva Sweden AB 105 21 Stockholm, Sweden
Maltese: Valneva Sweden AB 105 21 Stockholm, L-Iżvezja
English: Following a booster dose 10-12 months after primary immunisation, the protective efficacy during the second year was 60.5% (95%CI: 28,79).
Maltese: Wara doża buster li ngħatat 10-12-il xahar wara l-ewwel immunizzazzjoni, l-effikaċja tal-protezzjoni fit-tieni sena kienet ta' 60.5% (95%CI: 28,79).
English: The heat-labile toxin (LT) of enterotoxigenic E. coli (ETEC ) is structurally, functionally and immunologically similar to CTB.
Maltese: It-tossina sensittiva għas-sħana (LT) ta' E. coli enterotossiġenika (ETEC), għandha struttura, funzjoni, u kwalitajiet immunoloġiċi simili għal CTB.
English: The immune responses to Dukoral were not studied.
Maltese: Ir respons immuni għal Dukoral ma ġiex studjat.
English: 20x1 dose
Maltese: 20 x doża 1
English: Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.
Maltese: Dukoral huwa indikat bħala immunizzazzjoni attiva kontra l-mard ikkaġunat mill-Vibrio cholerae, sero-grupp O1 f'adulti u tfal minn sentejn 'l fuq, meta jkunu ser imorru f'żoni endemiċi /epidemiċi.
English: The vaccine protects adults and children from 2 years of age against cholera.
Maltese: Il vaċċin jipproteġi l-adulti u tfal mill-età ta' sentejn kontra l-kolera.
English: Other medicines and Dukoral
Maltese: Mediċini oħra u Dukoral
English: Protective effectiveness against cholera was evaluated during two mass-vaccination campaigns conducted in Mozambique (December 2003 - January 2004) and Zanzibar (February 2009 - May
Maltese: L-effikaċja protettiva kontra l-kolera ġiet evalwata matul żewġ kampanji ta' tilqim tal-massa mwettqa fil-Możambik (Diċembru 2003 - Jannar 2004) u f'Żanżibar (Frar 2009 - Mejju 2010).
English: − Recombinant cholera toxin B subunit (rCTB) 1 mg
Maltese: Subunità ta' tossina B tal-kolera rikombinanti (rCTB) 1 mg.
English: (produced in V. cholerae O1 Inaba, classical biotype strain 213.)
Maltese: 1 mg (magħmula fi V. cholerae O1 Inaba, bijo-tip klassiku razza 213.)
English: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated)
Maltese: Vibrio cholerae O1 Inaba, bijo-tip klassiku (inattivat bis-sħana)
English: 2x1 dose
Maltese: 2 x doża 1
English: • The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavour.
Maltese: • Il-granijiet li jfexfxu fihom sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate u essenza tat-tut.
English: 6 months-5 years
Maltese: 6 xhur-5 snin
English: DUKORAL suspension Cholera vaccine (inactivated, oral)
Maltese: DUKORAL suspensjoni Vaċċin tal-kolera , orali)
English: • if you have a disease of the immune system (including HIV infection).
Maltese: • jekk għandek marda fis-sistema immunitarja (inkluż infezzjoni tal-HIV).
English: 3 ml of suspension in a vial.
Maltese: 3 ml ta' sospensjoni fi flixkun
English: DUKORAL suspension Oral use.
Maltese: DUKORAL suspensjoni
English: The effervescent granules are filled in an amount of 5.6 g in sachets with an inner layer of polyester/LD-polyethylene and an outer layer of aluminium/LD-polyethylene.
Maltese: polyethylene u saff fuq barra ta' aluminju/LD-polyethylene.
English: The sodium hydrogen carbonate is supplied as effervescent granules, which should be dissolved in a glass of cool water (approx. 150 ml).
Maltese: Is-sodium hydrogen carbonate huwa fornut bħala granijiet li jfexfxu, li għandhom jinħallu f'tazza ilma frisk (madwar 150 ml).
English: Pack sizes: 1x1 dose, 2x1 dose, 20x1 dose Not all pack sizes may be marketed.
Maltese: Daqsijiet tal-pakketti: doża 1x1, 2 x doża 1, 20 x doża 1
English: In the longitudinal cohort-analysis conducted during the mass-vaccination campaign in Zanzibar, protective effectiveness after 2 doses of Dukoral was 79% (95% CI, 47, 92) for a follow-up period of 15 months.
Maltese: Fl-analiżi koorti lonġitudinali mwettqa matul il-kampanja ta' tilqim tal-massa f'Żanżibar, l-effikaċja protettiva wara 2 dożi ta' Dukoral kienet 79% (95% CI, 47, 92) għal perjodu ta' follow-up ta' 15-il xahar.
English: The duration of the immunological memory was estimated to last for at least 2 years in adults.
Maltese: Il-memorja immunoloġika hija stmata li ddum mill-anqas sentejn fl-adulti.
English: Preliminary results from a clinical study including a limited number of volunteers showed no interaction with the antibody response to Dukoral when a live oral vaccine (enterocapsules) against typhoid was given simultaneously with Dukoral.
Maltese: Riżultati preliminarji minn studju kliniku fuq numru ristrett ta' voluntiera, urew li ma kienx hemm interazzjoni mar-respons ta' l-antikorpi għal Dukoral, meta dan ingħata fl-istess ħin ma' vaċċin (enterokapsuli) ħaj orali ta' kontra t-tifojde.
English: Evaluation of safety varied between trials with respect to mode of surveillance, definition of symptoms and time of follow-up.
Maltese: L-evalwazzjoni tas-sigurtà kienet differenti bejn prova u oħra minħabba varjazzjonijiet fil-mod ta' sorveljanza, ta' definizzjoni tas-sintomi, u t-tul taż-żmien ta' visti sussegwenti.
English: Immunisation does not protect against V. cholerae serogroup O139 or other species of Vibrio.
Maltese: tipproteġix kontra V. cholerae serogrupp O139 jew speċijiet oħrajn ta' Vibrio.
English: Dukoral contains approximately 1.1 g sodium per dose.
Maltese: Doża waħda fiha madwar 1.1 g sodium.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to formaldehyde.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1 jew formaldehyde.
English: Infections and infestations: Gastroenteritis
Maltese: Disturbi gastro-intestinali:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sodium hydrogen carbonate 5.6 g, sachet
Maltese: Sodium hydrogen carbonate, qartas ta' 5.6 g
English: Before ingestion, the suspension should be mixed with the buffer (sodium hydrogen carbonate) solution.
Maltese: Qabel jinbela, is-sospensjoni għandha titħallat mas-soluzzjoni buffer (sodium hydrogen carbonate).
English: Study location
Maltese: KLINIKU
English: The vaccine contains killed whole V. cholerae O1 bacteria and the recombinant non-toxic B-subunit of the cholera toxin (CTB).
Maltese: Il-vaċċin fih batterji sħaħ maqtula ta' l-ispeċi V. cholerae O1, kif ukoll subunità B mhux tossika rikombinanti tat-tossina tal-kolera (CTB).
English: Dukoral is presented as a suspension and effervescent granules for oral suspension.
Maltese: DUKORAL, suspensjoni u granijiet li jfexfxu għal suspensjoni orali.
English: Each dose of vaccine suspension (3 ml) contains:
Maltese: Kull doża tas-suspensjoni (3 ml) tal-vaċċin fiha:
English: In the case-control study conducted during the mass vaccination campaign in Mozambique, protective effectiveness of 2 doses of Dukoral was 84% (95% CI: 43, 95, per-protocol analysis; p=0.005) for the initial 5 months of follow-up.
Maltese: Fl-istudju ta' kontroll tal-każijiet imwettaq matul il-kampanja tat-tilqim tal-massa fil-Możambik, l effikaċja protettiva ta' 2 dożi ta' Dukoral kienet 84% (95% CI: 43, 95, kull analiżi skont il-protokoll;
English: Vascular disorders: Hypertension
Maltese: Paraestesija Disturbi vaskulari:
English: MM/YYYY
Maltese: L-Iżvezja
English: The anti-toxin intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface thereby preventing the toxin-mediated diarrhoeal symptoms.
Maltese: antikorpi ta' l-imsaren ta' kontra t-tossina jimpedixxu t-tossina tal-kolera milli teħel mal-wiċċ mukuż tal-musrana, u b'hekk jiġu evitati s-sintomi tad-dijarea ikkaġunati mit-tossina.
English: − Recombinant cholera toxin B subunit (rCTB) 1 mg. *bacterial content prior to inactivation
Maltese: − Subunità ta' tossina B rikombinanti tal-kolera (rCTB) 1 mg. * kontenut ta' batterji qabel l-inattivazzjoni
English: Caution should be taken in subjects with known hypersensitivity to formaldehyde.
Maltese: Wieħed għandu jeżerċita attenzjoni meta jkun hemm jkun magħruf li l-persuna għandha sensittività eċċessiva għal formaldehyde.
English: Citric acid
Maltese: Sodium hydrogen carbonate Citric acid
English: 5 How to store Dukoral Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: No established immunological correlates of protection against cholera after oral vaccination have been identified.
Maltese: Ma ġewx stabbiliti korrelazzjonijiet immunoloġiċi protettivi kontra l-kolera wara vaċċinazzjoni orali.
English: For children of 2 to below6 years: pour away half of the buffer solution.
Maltese: Għal tfal ta' bejn 2 sa inqas minn 6 snin: armi nofs is-soluzzjoni buffer.
English: In the Bangladesh field trial, protective efficacy of Dukoral in the overall population was 85% (95%CI: 56, 95, per-protocol analysis) for the initial 6 months of follow-up.
Maltese: Dukoral, b'mod ġenerali, fil-popolazzjoni, kienet ta' 85% (95%CI: 56, 95,f'kull analiżi skond il protokoll) fl-ewwel 6 xhur ta' l-istudju ta' wara.
English: In the second trial, conducted in Peru and enrolling military recruits, the short-term protective efficacy against cholera after 2 vaccine doses was 85% (95%CI: 36, 97, per-protocol analysis).
Maltese: Fit-tieni prova li saret il-Peru, fuq rekluti militari, l-effikaċja tal-protezzjoni kontra l-kolera għal żmien qasir, kienet ta' 85% (95%CI: 36, 97, f'kull analiżi skond il-protokoll) wara żewġ dożi talvaċċin.
English: Adverse reactions reported are consistent with those seen after the recommended dosing.
Maltese: L-effetti avversi li ġew irrapportati huma konsistenti għal dawk osservati wara li tingħata id-doża rakkomandata.
English: Pharmacotherapeutic group: Bacterial vaccines, ATC-code: J07AE01
Maltese: Vaċċini batteriċi, Kodiċi ATC:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria*
Maltese: Vibrio cholerae O1 Inaba, bijo-tip El Tor (inattivat bil-formalina) 31,25x109 batterji* Vibrio cholerae O1 Ogawa, bijo-tip klassiku (inattivat bis-sħana) 31,25x109 batterji* Vibrio cholerae O1 Ogawa, bijo-tip klassiku (inattivat bil-formalina) 31,25x109 batterji*
English: Mix by gently stirring.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: Cholera vaccine (inactivated, oral)
Maltese: Vaċċin kontra l-kolera (inattivat, orali)
English: • The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water for injections.
Maltese: • Is-sustanzi l-oħra fis-suspensjoni tal-vaċċin huma sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride u ilma għall-injezzjonijet.
English: Chlorinated water can be used.
Maltese: Jista' jintuża ilma klorinat.
English: 31.25x109 bacteria* of each of the following V. cholerae O1 strains: Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated).
Maltese: (inattivat bis-sħana), bijo-tip Inaba El Tor (inattivat bil-formalina), bijo-tip klassiku Ogawa (inattivat bis-sħana), bijo-tip klassiku Ogawa (inattivat bil-formalina).
English: Respiratory symptoms (including rhinitis and cough) Gastrointestinal disorders Uncommon Diarrhoea, abdominal cramps, abdominal pain, stomach/abdominal gurgling (gas), abdominal discomfort
Maltese: Mhux komuni Dijarea, brim addominali, uġigħ addominali, tgergir fl-istonku/addominali (gass),
English: PACKAGE LEAFLET: INFORMATION FOR THE USER DUKORAL suspension and effervescent granules for oral suspension
Maltese: Informazzjoni għall-utent DUKORAL, suspensjoni u granijiet li jfexfxu għal suspensjoni għal użu orali
English: Respiratory, thoracic and mediastinal disorders: Dyspnoea, increased sputum Gastrointestinal disorders: Flatulence
Maltese: Infezzjonijiet u infestazjonijiet: Gastroenterite Disturbi tad-demm u tas-sistema limfatika:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 sodium hydrogen carbonate sachets)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA DUKORAL - 20 x 1 pakkett ta' doża (kartuna ta' ġewwa għal 20 qartas ta' sodium hydrogen carbonate)
English: Pour the content of the Dukoral® suspension vial into the glass of buffer solution (see 1).
Maltese: 3. Ferra' l-kontenut tal-flixkun tas-suspensjoni Dukoral® fit-tazza tas-soluzzjoni buffer (ara 1).
English: Sodium hydrogen carbonate
Maltese: Granijiet li jfexfxu ta' sodium hydrogen carbonate
English: In addition to the direct protection, it was shown that Dukoral provides significant indirect (herd) protection in the studied setting.
Maltese: Barra mill-protezzjoni diretta, intwera li Dukoral jipprovdi protezzjoni indiretta sinifikanti (fi grupp) fl-ambjent studjat.
English: Raspberry flavour
Maltese: TAGĦRIF
English: After getting the vaccine, your body will make substances called antibodies, which fight the cholera bacteria and toxin that cause diarrhoea.
Maltese: Wara li jitlaqqam, ġismek jagħmel sustanzi msejħin antikorpi, li jiġġieldu l-batterji tal-kolera u t-tossin li jikkawżaw dijarrea.
English: Nervous system disorders Uncommon Headache Rare
Maltese: Disturbi fis-sistema nervuża
English: - granules for oral suspension in a sachet ::
Maltese: - granijiet għal suspensjoni orali f'qartas:
English: There is a poor correlation between serum antibody responses, including vibriocidal antibody response, and protection.
Maltese: Hemm korrelazzjoni batuta bejn ir-respons ta' l-antikorpi fis-serum, li jinkludu r-respons ta' l-antikorpi vibrijoċidali u l-protezzjoni miksuba.
English: Dukoral has been given to children between 1 and 2 years of age in safety and immunogenicity studies, but the protective efficacy has not been studied in this age group.
Maltese: Tfal iżgħar minn sentejn Dukoral ingħata lil tfal ta' bejn 1 u 2 waqt studji dwar is-sigurtà u immunoġeniċità, iżda ma kien hemm l-ebda studju dwar l-effikaċja tal-protezzjoni f'dan il-grupp ta' età.
English: However, immunological and duration of protection data suggest that if up to 2 years have elapsed since the last vaccination for adults and up to 6 months for children aged 2 to below 6 years a single booster dose should be given.
Maltese: Madankollu, informazzjoni immunoloġika u dwar it-tul tal-protezzjoni tissuġerixxi li għandha tingħata doża buster waħda jekk ikunu għaddew sa sentejn minn meta tkun ittieħdet l-aħħar vaċċinazzjoni għal adulti u sa 6 xhur għattfal li għandhom bejn sentejn sa inqas minn 6 snin.
English: Efficacy against cholera
Maltese: Effikaċja kontra l-kolera
English: Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vaccine vial.
Maltese: Tfal bejn 2 sa inqas minn 6 snin ta' età: nofs is-soluzzjoni buffer għandha tintrema u l-bqija (madwar 75 ml) titħallat mal-kontenut kollu tal-flixkun tal-vaċċin.
English: • Flu -like symptoms, chestiness, chills, general pain, weakness
Maltese: • Sintomi bħal tal-influwenza, disturbi tan-nifs, tertir, uġigħ ġenerali, dgħjufija
English: The effervescent granules should be dissolved in approximately 150 ml of cool water to get the buffer solution.
Maltese: Il-granijiet li jfexfxu għandhom jinħallu f'madwar 150 ml ta' ilma frisk sabiex tinkiseb is-soluzzjoni buffer.
English: The vaccine acts by inducing antibodies against both the bacterial components and CTB.
Maltese: Il-vaċċin jaħdem billi jġiegħel l-żvilupp ta' antikorpi kontra l-komponenti tal-batterji u kontra CTB.
English: Elderly
Maltese: Sturdament
English: To prepare the buffer solution,dissolve the effervescent granules in a glass of cool water (approx. 150 ml) by gently stirring.
Maltese: Biex tipprepara s-soluzzjoni buffer, dewweb il-granijiet li jfexfxu f'tazza ilma frisk (madwar 150 ml)
English: Table: Protective efficacy against cholera in the Bangladesh study (per-protocol analysis) Protective efficacy, % (95% CI) Adults and children >6 year
Maltese: Effikaċja ta' protezzjoni, % (95% CI) Adulti u tfal >6 snin Tfal 2-6 snin
English: Data on overdose are limited.
Maltese: Informazzjoni fuq doża eċċessiva hija ristretta.
English: The standard primary course of vaccination with Dukoral against cholera consists of 2 doses for adults and children from 6 years of age.
Maltese: Il-kors primarju standard ta' vaċċinazzjoni kontra l-kolera b'Dukoral, jikkonsisti f'2 dożi għall-adulti,
English: • Diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort
Maltese: • Dijarea, uġigħ fl-istonku, brim fl-istonku, stonku jgerger, stonku minfuħ, gass fl-istonku, skonfort ġenerali ta' l-istonku
English: Suspension and effervescent granules for oral suspension: - Suspension for oral suspension
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni u granijiet li jfexfxu għal suspensjoni orali: - Suspensjoni għal suspensjoni orali - Granijiet għal suspensjoni orali f'qartas.
English: Other side effects (frequency cannot be estimated from the available data)
Maltese: Effetti sekondarji oħrajn (il-frekwenza ma tistax tiġi stmata mid-data disponibbli)
English: Valneva Sweden AB SE-105 21 Stockholm Sweden
Maltese: SE-105 21 Stockholm
English: 1993-95 2 doses 2 weeks apart with a booster dose 1 year later
Maltese: 1993-95 2 dożi b'intervalli ta' ġimgħatejn b'doża buster sena wara
English: Very rare side effects (may affect up to 1 in a 10,000 people)
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000)
English: The antibacterial intestinal antibodies prevent the bacteria from attaching to the intestinal wall thereby impeding colonisation of V. cholerae O1.
Maltese: L-antikorpi ta' kontra l-batterji fl-imsaren, ixekklu l batteri milli jeħlu mal-ħajt ta' l-imsaren u għalhekk ixekklu l-kolonizzazzjoni ta' V. cholerae O1. L
English: No other vaccines/ medicinal products, including oral polio vaccine and antimalarials, have been given simultaneously with Dukoral in clinical studies.
Maltese: Dukoral qatt ma ngħata fl-istess ħin ma' vaċċini/prodotti mediċinali oħrajn, li jinkludu l-vaċċin orali ta' kontra l-poljo u mediċini orali kontra l-malarja fi studji kliniċi.
English: • Sweating, shivering
Maltese: Rimettar, dardir
English: Efficacy against cholera was assessed in three randomised double-blind placebo-controlled clinical trials conducted in Bangladesh (endemic region) and in Peru (non-endemic region).
Maltese: L-effikaċja kontra l-kolera ġiet stmata fi tliet provi kliniċi li kienu randomised double-blind u kontrollati bi plaċebo.
English: − 31.25x109 bacteria* of each of the following V. cholerae O1 strains: Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated).
Maltese: − 31,25x109 batterji* ta' kull wieħed mir-razzez ta' V. cholerae O1 li ġejjin: bijo-tip klassiku Inaba
English: Dukoral contains approximately 1.1 g sodium per dose, which should be taken into consideration by patients on a controlled sodium diet.
Maltese: Dukoral fih bejn wieħed u ieħor 1.1 g sodju għal kull doża.
English: Immunisation should be completed at least 1 week prior to potential exposure to V. cholerae O1.
Maltese: Il-kors ta' immunizzazzjoni għandu jintemm mill-anqas ġimgħa qabel ikun hemm xi espożizzjoni potenzjali għal V. cholerae O1.
English: The suspensionsupplied in a single-dose glass vial is a whitish suspension.. Each vial comes with one sachet package that contains white effervescent granules of sodium hydrogen carbonate.
Maltese: Kull flixkun jiġi f'pakkett ta' qartas wieħed li fih granuli effervexxenti bojod ta' sodium hydrogen carbonate.
English: Rare side effects (may affect up to 1 in a 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: A. LABELLING
Maltese: (rCTB)
English: The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper (bromobutyl rubber) and a screw cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Is-suspensjoni tal-vaċċin hija mimlija f'volum ta' 3 ml fi fliexken (ħġieġ tip I) b'tapp tal-lastku (lastku bromobutyl u għatu tal-kamin.
English: Sodium hydrogen carbonate Effervescent granules
Maltese: Sodium hydrogen carbonate Granijiet li jfexfxu
English: The safety of Dukoral was assessed in clinical trials, including both adults and children from 2 years of age, conducted in endemic and non-endemic countries for cholera and enterotoxigenic Escherichia coli (ETEC) producing heat-labile enterotoxin (LT).
Maltese: Is-sigurtà ta' Dukoral kienet evalwata waqt provi kliniċi, fuq adulti u tfal minn sentejn 'il fuq, kemm f'pajjiżi endemiċi kif ukoll f'pajjiżi mhux endemiċi għall-kolera u Escherichia coli enterotossiġenika (ETEC), li jipproduċu enterotossina li ma tkunx stabbli fis-sħana (LT). 'Il fuq minn 94,000 doża ta' Dukoral intużaw waqt studji kliniċi.
English: 1994 2 doses 7-11 days apart
Maltese: 2 dożi b'intervalli ta' 7-11-il jum 1,563 (18-65 sena)
English: • Swelling irritation inside the nose, and cough.
Maltese: • Irritazzjoni b'nefħa ġewwa l-imnieħer u sogħla.
English: An exploratory analysis suggested that 2 vaccine doses seemed as effective as 3 doses in adults.
Maltese: Stħarriġ esploratorju wera li f'adulti, 2 dożi ta' vaċċinazzjoni dehru li huma effettivi daqs 3 dożi
English: Musculoskeletal and connective tissue disorders Very rare Joint pain
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Like all medicines, Dukoral can cause side effects, although not everybody gets them.
Maltese: Uġigħ, sindrome simili għall-influwenza,