qanastek/EMEA-V3 huggingface dataset:
Its use should be postponed in patients with a short-lived illness affecting the stomach or gut, or with a fever.
L- użu tiegħu għandu jiġi pospost f’ pazjenti b’ mard qasir li jaffettwa l- istonku jew l- imsaren, jew bid- deni.
Why has Dukoral been approved?
Għaliex ġie approvat Dukoral?
The Committee for Medicinal Products for Human Use (CHMP) noted that the risk of cholera for regular tourists is minor, but that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Uman (is- CHMP) innota li r- riskju tal- kolera għal turisti regolari huwa wieħed baxx, iżda li Dukoral jista ’ jkun importanti għal ċerti gruppi ta ’ nies, bħall- ħaddiema tas- saħħa waqt l- epidemiji tal- kolera.
The Committee decided that Dukoral’ s benefits are greater than its risks for active immunisation against disease caused by V. cholerae serogroup O1.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Dukoral huma ikbar mir- riskji tiegħu għat- tilqim attiv kontra l- mard ikkawżat mill- V. cholerae serogrupp O1.
The Committee recommended that Dukoral be given marketing authorisation.
Il- Kumitat irrakkomanda li Dukoral jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Dukoral:
Informazzjoni oħra dwar Dukoral:
The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral to SBL Vaccin AB on 28 April 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Dukoral lil SBL Vaccin AB fit- 28 ta ’ April 2004.
The marketing authorisation was renewed on 28 April 2009.
L- awtorizzazzjoni għat- tqegħid fuq is- suq ġiet imġedda fit- 28 ta ’ April 2009.
The full EPAR for Dukoral can be found here.
2/ 3 L- EPAR sħiħ għal Dukoral jista ’ jinstab hawnhekk.
This summary was last updated in 04-2009.
Dan is- sommarju ġie aġġornat l- aħħar fi 04- 2009.
DUKORAL suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
Vaċċin kontra l- kolera (inattivat, orali).
Each dose of vaccine suspension (3 ml) contains: − A total of 1x1011 bacteria of the following strains:
Kull doża tas- suspensjoni (3 ml) tal- vaċċin fiha:
Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated)
Numru totali ta ’ 1x1011 batterji ta ’ dawn ir- razzez: − 25x109 batterji * Vibrio cholerae O1 Inaba, bijo- tip klassiku (inattivat bis- sħana) 25x109 batterji * Vibrio cholerae O1 Inaba, bijo- tip El Tor (inattivat bil- formalina) 25x109 batterji * Vibrio cholerae O1 Ogawa, bijo- tip klassiku (inattivat bis- sħana) Vibrio cholerae O1 Ogawa, bijo- tip klassiku (inattivat bil- formalina) 25x109 batterji * −
25x109 bacteria* 25x109 bacteria* 25x109 bacteria*
Subunità ta 'Tossina B tal- kolera rikombinanti (rCTB)
− Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in V. cholerae O1 Inaba, classical biotype strain 213.)
(magħmula fi V. cholerae O1 Inaba, bijo- tip klassiku razza 213.)
* Bacterial count before inactivation.
* L- għadd ta ’ batterji qabel ma ġew inattivati.
Sodium dihydrogen phosphate monohydrate 1.7 mg, disodium phosphate dihydrate 9.4 mg, sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg, saccharin sodium 30 mg, sodium citrate 6 mg.
Sodium dihydrogen phosphate monohydrate 1. 7 mg, disodium phosphate dihydrate 9. 4 mg, sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg, saccharin sodium 30 mg, sodium citrate 6 mg.
One dose contains approximately 1.1 g sodium.
Doża waħda fiha madwar 1. 1 g sodium.
Suspension and effervescent granules for oral suspension.
Suspensjoni u granijiet li jfexfxu għal suspensjoni orali.
The suspension, supplied in a vial is whitish.
Is- suspensjoni fornuta f’ kunjett hija bajdanija.
The effervescent granules, supplied in a sachet, are white.
Il- granijiet li jfexfxu, fornuti f' qartas, huma bojod.
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.
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.
The use of DUKORAL should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.
Id- deċiżjoni dwar l- użu ta ’ DUKORAL għandha tiġi stabbilita skond rakkomandazzjonijiet uffiċjali li jqisu kemm il- varjabilità epidemjoloġika kif ukoll ir- riskju li tittieħed il- marda f’ żoni ġeografikament differenti u l- kundizzjonijiet waqt il- vjaġġ.
DUKORAL should not replace standard protective measures.
DUKORAL m’ għandux jissostitwixxi miżuri ta ’ ħarsien standard.
In the event of diarrhoea measures of rehydration should be instituted.
Għandu jinbeda trattament ta ’ re- idratazzjoni f’ każ ta ’ dijarea.
2 The standard primary course of vaccination with DUKORAL against cholera consists of 2 doses for adults and children from 6 years of age.
Skeda tal- vaċċinazzjoni primarja Il- kors primarju standard ta ’ vaċċinazzjoni kontra l- kolera b’ DUKORAL, jikkonsisti f’ 2 dożi għall - adulti, kif ukoll għat- tfal minn 6 snin ’ l fuq.
Children 2 to 6 years of age should receive 3 doses.
Tfal ta ’ bejn 2 u 6 snin, għandhom jingħataw 3 dożi.
Doses are to be administered at intervals of at least one week.
Bejn 2 doża u oħra, għandu jkun hemm intervall ta ’ mill- anqas ġimgħa.
If more than 6 weeks have elapsed between doses, the primary immunisation course should be re-started.
Jekk dan l- intervall ta ’ bejn id- dożi ikun qabeż 6 ġimgħat, il- kors primarju ta ’ l- immunizzazzjoni jrid jinbeda mill- ġdid.
Immunisation should be completed at least 1 week prior to potential exposure to V. cholerae O1.
Il- kors ta ’ immunizzazzjoni għandu jintemm mill- anqas ġimgħa qabel ikun hemm xi espożizzjoni potenzjali għal V. cholerae O1.
Booster dose For continuous protection against cholera a single booster dose is recommended within 2 years for adults and children from 6 years of age, and after 6 months for children aged 2 to 6 years.
Doża buster Għal ħarsien kontinwu kontra l- kolera, huwa rakkomandat li fi żmien sentejn tingħata doża buster lill - adulti u lit- tfal minn 6 snin ’ l fuq, u wara 6 xhur f’ każ ta ’ tfal bejn 2 u 6 snin.
No clinical efficacy data has been generated on repeat booster dosing.
M’ hemmx tagħrif kliniku fuq l- effikaċja ta ’ dożi buster ripetuti.
However, immunological data suggest that if up to 2 years have elapsed since the last vaccination a single booster dose should be given.
Madankollu, informazzjoni immunoloġika tissuġerixxi li għandha tingħata doża buster waħda jekk ikunu għaddew sa sentejn minn meta tkun ittieħdet l- aħħar vaċċinazzjoni.
If more than 2 years have elapsed since the last vaccination the primary course should be repeated.
Il- kors primarju għandu jerġa ’ jingħata jekk ikunu għaddew aktar minn sentejn mill- aħħar vaċċinazzjoni.
Children less than 2 years 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.
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.
Therefore, DUKORAL is not recommended to be used in children less than 2 years of age.
Għalhekk, l- użu ta ’ DUKORAL mhux rakkomandat fi tfal ta ’ anqas minn sentejn.
Elderly There are only very limited data on protective efficacy of the vaccine in subjects aged 65 years and more.
Anzjani Teżisti biss dejta limita ħafna dwar l- effikaċja protettiva tal- vaċċin f’ individwi li għandhom 65 sena u aktar.
Method of administration The vaccine is intended for oral use.
Kif jingħata Il- vaċċin huwa maħsub għal użu orali.
Before ingestion, the vaccine suspension should be mixed with a sodium hydrogen carbonate solution.
Qabel jinbela, is- sospensjoni tal- vaċċin għandha titħallat ma ’ soluzzjoni ta ’ sodium hydrogen carbonate.
150 ml).
Is- sodium hydrogen carbonate huwa fornut bħala granijiet li jfexfxu, li għandhom jinħallu f’ tazza ilma frisk (madwar 150 ml).
The vaccine suspension should then be mixed with the sodium hydrogen carbonate solution and drunk within 2 hours.
Is- suspensjoni tal- vaċċin għandha titħallat mas- soluzzjoni ta ’ sodium hydrogen carbonate, u għandha tinxtorob fi żmien sagħtejn.
Food and drink should be avoided 1 hour before and 1 hour after vaccination.
Ikel u xorb għandu jiġi evitat għal siegħa qabel u siegħa wara l- vaċċinazzjoni.
Oral administration of other medicinal products should be avoided within 1 hour before and after administration of DUKORAL.
Wieħed għandu jevita milli jieħu mediċini mill- ħalq, minn siegħa qabel sa siegħa wara li jingħata DUKORAL.
75 ml) is mixed with the entire contents of the vaccine vial.
Tfal ta ’ bejn 2 sa 6 snin: nofs is- soluzzjoni ta ’ sodium hydrogen carbonate għandha titwarrab, u l- bqija (madwar 75 ml) għandha titħallat mal- kontenut kollu tal- kunjett li fih il- vaċċin.
Hypersensitivity to the active substances, to any of the excipients or to formaldehyde.
Sensittività eċċessiva għas- sustanzi attivi, għal xi sustanzi mhux attivi jew għal formaldehyde.
Administration of DUKORAL should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness.
It- teħid ta ’ DUKORAL għandu jkun differit meta jkun hemm persuni li jbatu minn mard akut tas - sistema gastrointestinali jew mard akut bid- deni.
No clinical data on protective efficacy of DUKORAL against cholera after administration of booster doses are available.
M’ hemmx tagħrif kliniku fuq l- effikaċja tal- protezzjoni ta ’ DUKORAL kontra l- kolera, wara li jingħataw id- dożi buster.
DUKORAL confers protection specific to Vibrio cholerae serogroup O1.
DUKORAL joffri protezzjoni speċifika kontra Vibrio cholerae serogrupp O1.
Immunisation does not protect against V. cholerae serogroup O139 or other species of Vibrio.
L- immunizzazzjoni ma ’ tipproteġix kontra V. cholerae serogrupp O139 jew speċijiet oħrajn ta ’ Vibrio.
In subjects infected with HIV, limited data are available on immunogenicity and safety of the vaccine.
F’ individwi infettati b’ HIV, hemm biss tagħrif ristrettt fuq l- immunoġeniċità u s- sigurtà tal- vaċċin.
Vaccine protective efficacy has not been studied.
L- effikaċja tal- protezzjoni tal- vaċċin ma ġietx studjata.
Immunisation of HIV infected subjects could result in transient increases of viral load.
Meta persuni infettati b’ HIV jiġu mlaqqma, jista ’ jkollhom żjidiet temporanji fil- viral load.
DUKORAL may not induce protective antibody levels in subjects with advanced HIV disease.
Pazjenti infettati b’ HIV b’ mod avvanzat għandhom mnejn ma jiżviluppawx livelli protettivi ta ’ antikorpi meta jingħataw DUKORAL.
However, an effectiveness study in a population with high HIV prevalence showed similar protection as in other populations.
Madankollu, studju tal- effikaċja f’ popolazzjoni bi prevalenza tal- HIV għolja wera protezzjoni simili bħal f’ popolazzjonijiet oħrajn.
3 Antibody response in vaccinees with endogenous or iatrogenic immunosuppression may be insufficient.
3 Respons tal- antikorpi f’ nies imlaqqma b’ immunosuppressjoni endoġena jew jatroġenika jista ’ ma jkunx biżżejjed.
Formaldehyde is used during the manufacturing process and trace amounts may be present in the final product.
Formaldehyde jintuża waqt il- proċess tal- manifattura u għalhekk jista ’ jifdal traċċi fil- prodott finali.
Caution should be taken in subjects with known hypersensitivity to formaldehyde.
Wieħed għandu jeżerċita attenzjoni meta jkun hemm jkun magħruf li l- persuna għandha sensittività eċċessiva għal formaldehyde.
DUKORAL contains approximately 1.1 g sodium per dose, which should be taken into consideration by patients on a controlled sodium diet.
Dan għandu jiġi kkunsidrat mill - pazjenti fuq dieta tas- sodju kkontrollata.
The vaccine does not provide complete protection and it is important to adhere to standard protective measures to avoid cholera.
Il- vaċċin ma jagħtix ħarsien sħiħ, u għalhekk huwa importanti li wieħed isegwi l- miżuri standard ta ’ protezzjoni biex jevita l- kolera.
The vaccine is acid labile.
Il- vaċċin jiġi affettwat bl- aċidu.
Food and/ or drink will increase acid production in the stomach and the effect of the vaccine may be impaired.
L- ikel u x- xorb ser iżidu l- produzzjoni ta ’ l- aċidu fl- istonku u għalhekk l- effett tal- vaċċinazzjoni għandu mnejn ikun imfixkel.
Consequently, food and drink should be avoided 1 hour before and 1 hour after vaccination.
Għalhekk, m’ għandux jittieħed la ikel u lanqas xorb minn siegħa qabel sa siegħa wara li tingħata l- vaċċinazzjoni.
Oral administration of other vaccines and medicinal products should be avoided 1 hour before and 1 hour after vaccination.
Għandu jiġi evitat it- teħid ta ’ vaċċini jew prodotti mediċinali oħrajn mill- ħalq, minn siegħa qabel sa siegħa wara li tingħata l- vaċċinazzjoni.
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.
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.
The immune response to live typhoid vaccine was not investigated in this study.
F’ dan l- istudju ma ġiex studjat ir- respons immuni għal vaċċin ħaj ta ’ kontra t- tifojde.
Similarly, a yellow fever vaccine was given concomitantly with DUKORAL, and there was no interaction observed with the immune response to the yellow fever vaccine.
Bl- istess mod, meta DUKORAL ingħata fl- istess ħin ma ’ vaċċin kontra d- deni isfar, ma kienx hemm interazzjoni osservata mar- respons immuni għall- vaċċin tad- deni isfar.
The immune responses to DUKORAL were not studied.
Ir - respons immuni għal DUKORAL ma ġiex studjat.
No other vaccines/ medicinal products, including oral polio vaccine and antimalarials, have been given simultaneously with DUKORAL in clinical studies.
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.
No animal data on reproduction toxicity are available.
M’ hemmx tagħrif dwar il- ħsara fuq is- sistema riproduttiva f' annimali.
Following careful benefit/ risk assessment the vaccine may be administered during pregnancy and to breast-feeding women although no specific clinical studies have been performed to address this issue.
Wara studju bir- reqqa tar- riskji u l- benefiċji, il- vaċċin jista ’ jintgħata waqt it- tqala u lil ommijiet li jkunu qegħdin ireddgħu għalkemm ma sarux studji kliniċi speċifiċi dwar dan il- punt
There is no evidence of an effect on the ability to drive and use machines.
Ma hemm ebda evidenza ta ’ effett fuq il- ħila ta ’ sewqan u t- tħaddim ta ’ magni.
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).
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.
Over 94,000 doses of DUKORAL were administered during the clinical trials.
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.
Evaluation of safety varied between trials with respect to mode of surveillance, definition of symptoms and time of follow-up.
Fil- biċċa l- kbira ta ’ l- istudji, l- effetti mhux mixtieqa ġew evalwati permezz ta ’ sorveljanza passiva.
In the majority of studies adverse events were assessed by passive surveillance.
L- aktar effetti mhux mixtieqa li kienu rraportati ta ’ spiss, kienu sintomi gastrointestinali bħal uġigħ addominali, dijarea, ippurgar maħlul, dardir u rimettar.
The most frequently reported adverse reactions, such as gastrointestinal symptoms including abdominal pain, diarrhoea, loose stools, nausea and vomiting, occurred at similar frequencies in vaccine and placebo groups.
Il - frekwenza ta ’ dawn ir- rapporti meta ngħatat il- vaċċinazzjoni kienet l- istess bħal tal- gruppi tal- plaċebo.
Frequency classification:
Klassifikazzjoni tal- frekwenzi:
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to ≤ 1/ 100); rare (≥ 1/ 10,000 to ≤ 1/ 1,000); very rare (≤ 1/ 10,000), not known (cannot be estimated form the available data).
Komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000), mhux magħrufa (ma tistax tiġi stmata mid- dejta disponibbli).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
4 Metabolism and nutrition disorder Rare Loss of / or poor appetite Very rare Dehydration
Disturbi fil- metaboliżmu u n- nutrizzjoni Rari Nuqqas t’ aptit/ jew kważi aptit ta ’ xejn Rari ħafna
Nervous system disorders Uncommon Headache Rare Dizziness Very rare Drowsiness, insomnia, fainting, reduced sense of taste
Disturbi fis- sistema nervuża Mhux komuni Uġigħ ta ’ ras Rari Sturdament Rari ħafna
Respiratory, thoracic and mediastinal disorders Rare Respiratory symptoms (including rhinitis and cough)
Disturbi respiratorji, toraċiċi u medjastinali Rari Sintomi respiratorji (li jinkludu rinite u sogħla)
Gastrointestinal disorders Uncommon Diarrhoea, abdominal cramps, abdominal pain, stomach/ abdominal gurgling (gas), abdominal discomfort Rare Vomiting, nausea Very rare Sore throat, dyspepsia
Disturbi gastro- intestinali Mhux komuni Dijarea, brim addominali, uġigħ addominali, tgergir fl- istonku/ addominali (gass), skonfort addominali Rari Rimettar, dardir Rari ħafna
Skin and subcutaneous tissue disorders Very rare Sweating, rash
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Rari ħafna
Musculoskeletal and connective tissue disorders Very rare Joint pain
Disturbi muskolu- skeltrali u tal- connective tissue Rari ħafna
General disorders and administration site conditions Rare Fever, malaise Very rare Fatigue, shivers
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Rari Deni, tħossok mhux f’ tiegħek Rari ħafna
Adverse reactions from post-marketing surveillance Additional adverse reactions reported during post-marketing surveillance are listed below.
Reazzjonijiet avversi irrapportati minn sorveljanza wara li tqiegħed il- prodott fis- suq Din li ġejja hija lista ta ’ effetti mhux mixtieqa rrapportati waqt sorveljanza minn wara li tqiegħed il- prodott fis- suq.
Infections and infestations:
Infezzjonijiet u infestazjonijiet:
Gastroenteritis Blood and lymphatic system disorders:
Gastroenterite Disturbi tad- demm u tas- sistema limfatika:
Lymphadenitis Nervous system disorders:
Limfadenite Disturbi fis- sistema nervuża:
Paraesthesia Vascular disorders:
Paraestesija Disturbi vaskulari:
Hypertension Respiratory, thoracic and mediastinal disorders:
Pressjoni għolja Disturbi respiratorji, toraċiċi u medjastinali:
Dyspnoea, increased sputum Gastrointestinal disorders:
Dispneja, żieda fir- rieq Disturbi gastro- intestinali:
Flatulence Skin and subcutaneous tissue disorders:
Gass Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
Urticaria, angioedema, pruritus General disorders and administration site conditions:
Urtikarja, anġjodema, ħakk Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata:
Pain, flu-syndrome, asthenia, chills
Uġigħ, sindrome ta ’ l- influwenza, astenja, sirdat
Data on overdose are extremely limited.
Informazzjoni fuq doża eċċessiva hija ristretta ħafna.
Adverse reactions reported are consistent with those seen after the recommended dosing.
L- effetti avversi li ġew irrapportati huma konsistenti għal dawk osservati wara li tingħata id- doża rakkomandata.
Bacterial vaccines, ATC-code:
Vaċċini batteriċi, Kodiċi ATC:
Mechanism of action The vaccine contains killed whole V. cholerae O1 bacteria and the recombinant non-toxic B-subunit of the cholera toxin (CTB).
5 Il- mod kif jaħdem Il- vaċċin fih batterji sħaħ maqtula ta ’ l- ispeċi V. cholerae O1, kif ukoll subunità B mhux tossika rikombinanti tat- tossina tal- kolera (CTB).
Bacterial strains of both Inaba and Ogawa serotypes and of El Tor and 5 Classical biotypes are included in the vaccine.
Fil- vaċċin hemm ukoll razzez ta ’ sero- tipi Inaba u Ogawa, kif ukoll bijo- tipi El Tor u Klassiċi.
DUKORAL is taken orally with bicarbonate buffer, which protects the antigens from the gastric acid.
DUKORAL jittieħed mill- ħalq, imħallat ma ’ baffer ta ’ bikarbonat, li jipproteġi l- antiġeni mill- aċidu ta ’ l- istonku.
The vaccine acts by inducing antibodies against both the bacterial components and CTB.
Il- vaċċin jaħdem billi jġiegħel l- żvilupp ta ’ antikorpi kontra l- komponenti tal- batterji u kontra CTB.
The antibacterial intestinal antibodies prevent the bacteria from attaching to the intestinal wall thereby impeding colonisation of V. cholerae O1.
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.
The anti-toxin intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface thereby preventing the toxin-mediated diarrhoeal symptoms.
L - 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.
The heat-labile toxin (LT) of enterotoxigenic E. coli (ETEC) is structurally, functionally and immunologically similar to CTB.
It- tossina sensittiva għas- sħana (LT) ta ’ E. coli enterotossiġenika (ETEC), għandha struttura, funzjoni, u kwalitajiet immunoloġiċi simili għal CTB.
The two toxins cross-react immunologically.
Iż- żewġ tossini jirreaġixxu immunoloġikament b’ mod inkroċjat.
6 Efficacy against cholera 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).
Dawn il- provi saru fil- Bangladexx (żona endemika) u l- Peru (żona li mhix endemika).
The number of patients enrolled, dosage regimens and follow-up periods are shown in the following table.
It- tabella li ġejja turi n- numru tal- pazjenti li ħadu sehem, ir- reġim tad- dożaġġ, u l- perijodi ta ’ visti ta ’ wara:
Study
Żona fejn sar
Year
Sena
Dosage regimen
Reġim tad- dożaġġ
Number
Numru
Follow up
Studju ta ’
(Age groups)
(gruppi skond l- età)
Cholera
wara
Bangladesh
Bangladexx
3 doses at 6 week intervals
3 dożi b’ intervalli ta ’ 6 ġimgħat
89,152 (2-65 years)
89, 152 (2- 65 sena)
6 months-5 years
6 xhur- 5 snin
Peru, military
Peru, militari
2 doses 7-11 days apart
2 dożi b’ intervalli ta ’ 7– 11- il jum
1,563 (18-65 years)
1, 563 (18- 65 sena)
5 months
5 xhur
2 doses 2 weeks apart with a booster dose 1 year later
sentejn
21,924 (2-65 years)
b’ doża buster sena wara
2 years
(2- 65 sena)
In the Bangladesh field trial, protective efficacy of DUKORAL in the overall population was 85% (95%CI:
L- istudju fil- post fejn saret ir- riċerka ġewwa Bangladexx wera li l- effikaċja tal- protezzjoni ta ’ DUKORAL, b’ mod ġenerali, fil- popolazzjoni, kienet ta ’ 85% (95% CI:
56, 95, per-protocol analysis) for the initial 6 months of follow-up.
56, 95, f’ kull analiżi skond il - protokoll) fl- ewwel 6 xhur ta ’ l- istudju ta ’ wara.
Duration of vaccine protection differed by age, lasting for 6 months in children and for 2 years in adults (see table below).
It- tul ta ’ żmien tal- protezzjoni mill- vaċċin varja skond l- età, minn 6 xhur fi tfal, u għal 2 snin fil- kbar (ara t- tabella t’ hawn isfel).
An exploratory analysis suggested that 2 vaccine doses seemed as effective as 3 doses in adults.
Stħarriġ esploratorju wera li f’ adulti, 2 dożi ta ’ vaċċinazzjoni dehru li huma effettivi daqs 3 dożi
Table:
Tabella:
Protective efficacy against cholera in the Bangladesh study (per-protocol analysis) Protective efficacy,% (95% CI)
L- effikaċja tal- protezzjoni kontra l- kolera, skond l- istudju fil- Bangladexx (kull analiżi skond il- protokoll) Effikaċja ta ’ protezzjoni,% (95% CI) 6 xhur
Children 2-6 years
Adulti u tfal > 6 snin 76 (30, 92)
76 (30, 92)
Tfal
100
2- 6 snin 100
1 year 2nd year
L- 1 sena
76 (60, 85) 60 (36, 76)
76 (60, 85)
44 (10, 65) 33 (-23, 64)
44 (10, 65)
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:
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, per-protocol analysis).
36, 97, f’ kull analiżi skond il- protokoll) wara żewġ dożi tal- vaċċin.
The third study, a field trial conducted in Peru, failed to show any protective efficacy against cholera during the first year.
It - tielet studju kien prova li sar fuq il- post ġewwa l- Peru naqas li juri effikaċja tal- protezzjoni kontra l - kolera waqt l- ewwel sena.
Following a booster dose 10-12 months after primary immunisation, the protective efficacy during the second year was 60.5% (95%CI:
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:
Protective efficacy of DUKORAL against cholera has not been studied following repeated booster vaccination.
L- effikaċja tal- protezzjoni ta ’ DUKORAL, kontra l- kolera, ma ġietx studjata meta jingħataw dożi buster ta ’ vaċċinazzjoni b’ mod ripetut.
Immunogenicity No established immunological correlates of protection against cholera after oral vaccination have been identified.
Immunogenicità Ma ġewx stabbiliti korrelazzjonijiet immunoloġiċi protettivi kontra l- kolera wara vaċċinazzjoni orali.
There is a poor correlation between serum antibody responses, including vibriocidal antibody response, and protection.
Hemm korrelazzjoni batuta bejn ir- respons ta ’ l- antikorpi fis- serum, li jinkludu r- respons ta ’ 6 l- antikorpi vibrijoċidali u l- protezzjoni miksuba.
Locally produced secretory IgA antibodies in the intestine probably mediate protective immunity.
Huwa probabbli li l- antikorpi tat- tip IgA li jnixxu fl- imsaren huma involuti fl- immunità protettiva.
The vaccine induced intestinal antitoxin IgA responses in 70-100% of vaccinated subjects.
F’ 70- 100% tal- persuni mlaqqma, il- vaċċin ġiegħel respons ta ’ anti- tossini tat- tip IgA fl- imsaren.
Serum vibriocidal antibodies against the bacterial components were seen in 35-55% of vaccinated subjects and antitoxic antibodies in 78-87% of vaccinated subjects.
Kien osservat li l- antikorpi vibrijoċidali fis- serum ta ’ kontra l- komponenti tal- batterji kienu preżenti f’ 35 - 55% tal- persuni vaċċinati, u l- antikorpi antitossiċi kienu preżenti f’ 78- 87% tal- persuni vaċċinati.
A booster dose elicited an anamnestic response indicative of an immune memory.
Doża buster qanqlet respons anamnestiku, indikattiv ta ’ memorja immunoloġika.
The duration of the immunological memory was estimated to last for at least 2 years in adults.
Il- memorja immunoloġika hija stmata li ddum mill- anqas sentejn fl- adulti.
Not applicable.
Mhux rilevanti.
7 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
No preclinical safety testing with the vaccine has been conducted.
Ma kienx hemm stħarriġ dwar is- sigurtà tal- vaċċin qabel l- użu kliniku.
Suspension:
Suspensjoni:
Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Sodium chloride Water for injections
Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Sodium chloride Ilma għall- injezzjonijiet
Effervescent granules:
Granijiet li jfexfxu:
Sodium hydrogen carbonate Citric acid Sodium carbonate, anhydrous Saccharin sodium Sodium citrate Raspberry flavour
Sodium hydrogen carbonate Citric acid Sodium carbonate, anhydrous Saccharin sodium Sodium citrate Essenza tat- tut
DUKORAL should only be mixed with the supplied effervescent granules dissolved in water.
DUKORAL għandu jitħallat biss mal- granijiet li jfexfxu fornuti, li jinħallu fl- ilma.
After the effervescent granules have been dissolved in water and the vaccine suspension has been added, the mixture should be drunk within 2 hours.
Wara li l- granijiet li jfexfxu jkunu ġew maħlula fl- ilma u s- suspensjoni tal- vaċċin miżjuda, it- taħlita għandha tinxtorob fi żmien sagħtejn.
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2°C – 8°C).
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.
Is- suspensjoni tal- vaċċin hija mimlija f’ volum ta ’ 3 ml f’ kunjetti (ħġieġ tip I) b’ tapp tal- lastku (lastku bromobutyl u għatu tal- kamin.
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.
7 Il- granijiet li jfexfxu huma mimlija f' ammont ta ’ 5. 6 g f’ qartas b’ saff fuq ġewwa ta ’ polyester/ LD - polyethylene u saff fuq barra ta ’ aluminju/ LD- polyethylene.
Each dose of vaccine is supplied with one sachet of effervescent granules.
Kull doża tal- vaċċin hija fornuta b’ qartas ta ’ granijiet li jfexfxu.
1x1 dose, 2x1 dose, 20x1 dose Not all pack sizes may be marketed.
Daqsijiet tal- pakketti: doża 1x1, 2 x doża 1, 20 x doża 1 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
8 The effervescent granules should be dissolved in approximately 150 ml of cool water.
Il- granijiet li jfexfxu għandhom jinħallu f’ madwar 150 ml ta ’ ilma frisk.
The vaccine vial should be shaken and the vaccine suspension should then be added to the sodium hydrogen carbonate solution and mixed well to obtain a colourless slightly opalescent solution.
Wara, il- kunjett tal- vaċċin għandu jitħawwad u mbagħad is- suspensjoni tal- vaċċin għandha tiżdied mas- soluzzjoni ta ’ sodium hydrogen carbonate u mħallta sew sabiex tinkiseb soluzzjoni ta ’ bla kulur kemmxejn opalexxenti.
75 ml) is mixed with the entire contents of the vaccine vial.
Tfal bejn 2 sa 6 snin ta ’ età: nofs is- soluzzjoni ta ’ sodium hydrogen carbonate għandha tintrema u l - bqija (madwar 75 ml) titħallat mal- kontenut kollu tal - kunjett tal- vaċċin.
SBL Vaccin AB S-105 21 Stockholm Sweden
SBL Vaccin AB S- 105 21 Stockholm L- Iżvezja
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA 'L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L- AWTORIZZAZZJONI 9.
Date of first authorisation:
Data tal- ewwel awtorizzazzjoni:
28 April 2004 Date of latest renewal:
28 ta ’ April 2004 Data ta ’ l- aħħar tiġdid:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
9 ANNEX II
8 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT B.
10 A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturers of the biological active substances
Isem u indirizz tal- manufatturi tas- sustanzi bijoloġiċi attivi
SBL Vaccin AB SE-105 21 Stockholm Sweden
SBL Vaccin AB SE- 105 21 Stockholm L- Iżvezja
UniTech BioPharma AB Storjorden 2 SE-864 31 Matfors Sweden
UniTech BioPharma AB Storjorden 2 SE- 864 31 Matfors L- Iżvezja
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- Suq għandu jagħti tagħrif lill- Kummissjoni Ewropea dwar il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
Official batch release: in accordance with Article 114 of Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ KEE kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
LABELLING AND PACKAGE LEAFLET
TIKKETTA
LABELLING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
DUKORAL – 1 dose package, 2x1 dose package, 20x1 dose package (outer sleeve)
DUKORAL – pakkett ta ’ doża waħda, 2 pakketti x doża waħda, 20 pakkett x doża waħda (kartuna ta ’ barra)
DUKORAL suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
Vaċċin kontra l- kolera (inattivat, orali)
Active substances:
Sustanzi attivi:
Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated). − Recombinant cholera toxin B subunit (rCTB) 1 mg.
Doża waħda fiha − 25x109 batterji * ta ’ kull wieħed mir- razzez ta ’ V. cholerae O1 li ġejjin: bijo- tip klassiku Inaba (inattivat mis- sħana), bijo- tip Inaba El Tor (inattivat bil- formalina), bijo- tip klassiku Ogawa (inattivat bis- sħana), bijo- tip klassiku Ogawa (inattivat bil- formalina). − Subunità ta ’ tossina B rikombinanti tal- kolera (rCTB) 1 mg.
*bacterial content prior to inactivation
* kontenut ta ’ batterji qabel l- inattivazzjoni
Contains sodium.
Fih is- sodju.
See the package leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal iktar informazzjoni.
3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet.
3 ml ta ’ suspensjoni f’ kunjett u 5. 6 g ta ’ granijiet li jfexfxu f’ qartas.
1 dose 2x1 dose 20x1 dose
Doża waħda 2x doża 1 20 x doża 1
Instructions 1.
Istruzzjonijiet 1.
150 ml).
Dewweb il- granijiet li jfexfxu f’ tazza ilma frisk (madwar 150 ml).
Children 2-6 years: pour away half of the solution.
Tfal ta 'bejn 2- 6 snin: armi nofs is- soluzzjoni.
Shake the vaccine vial (1 vial = 1 dose).
Ħawwad il- kunjett tal- vaċċin (kunjett 1 = doża 1).
Add the vaccine to the sodium hydrogen carbonate solution.
Żid il- vaċċin mas- soluzzjoni ta ’ sodium hydrogen carbonate.
Mix well and drink the mixture.
Ħawwad sew u ixrob it- taħlita
EXP MM/ YYYY
JIS XX/ SSSS
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
SBL Vaccin AB 105 21 Stockholm, Sweden
SBL Vaccin AB 105 21 Stockholm, L- Iżvezja
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 03/ 263/ 001 1 dose EU/ 1/ 03/ 263/ 002 2x1 dose EU/ 1/ 03/ 263/ 003 20x1 dose
EU/ 1/ 03/ 263/ 001 doża 1 EU/ 1/ 03/ 263/ 002 2 x doża 1 EU/ 1/ 03/ 263/ 003 20 x doża 1
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
DUKORAL – 20x1 dose package (inner carton for 20 vaccine vials)
DUKORAL – 20 x 1 pakkett ta ’ doża waħda (kartuna ta ’ ġewwa għal 20 kunjett tal- vaċċin)
DUKORAL suspension Cholera vaccine (inactivated, oral)
DUKORAL suspensjoni Vaċċin tal- kolera, orali)
Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated). − Recombinant cholera toxin B subunit (rCTB) 1 mg.
Doża waħda fiha − 25x109 batterji * ta ’ kull wieħed mir- razzez ta ’ V. cholerae O1 li ġejjin: bijo- tip klassiku Inaba (inattivat bis- sħana), bijo- tip Inaba El Tor (inattivat mill- formalina), bijo- tip klassiku Ogawa (inattivat bis- sħana), bijo- tip klassiku Ogawa (inattivat bil- formalina). − Subunità ta ’ tossina B rikombinanti tal- kolera (rCTB) 1 mg.
See the package leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
20x1 dose
3 ml ta ’ sospensjoni f’ kunjett 20 x doża 1
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA 'PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Justification for not including Braille accepted
Il- ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
DUKORAL – 20x1 dose package (inner carton for 20 sodium hydrogen carbonate sachets)
DUKORAL – 20 x 1 pakkett ta ’ doża (kartuna ta ’ ġewwa għal 20 qartas ta ’ sodium hydrogen carbonate)
Sodium hydrogen carbonate Effervescent granules
Sodium hydrogen carbonate Granijiet li jfexfxu
20 x 5.6 g
20 x 5. 6 g
To be used with DUKORAL.
Għandu jintuża ma ’ DUKORAL.
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
DUKORAL, vial label 1 dose
DUKORAL, Tikketta tal- kunjett ta ’ doża 1
DUKORAL suspension Oral use.
DUKORAL suspensjoni Użu orali.
EXP MM/ YYYY
EXP XX/ SSSS
1 dose (3 ml)
Doża waħda (3 ml)
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Sodium hydrogen carbonate 5.6 g, sachet
Sodium hydrogen carbonate, qartas ta ’ 5. 6 g
Sodium hydrogen carbonate effervescent granules Oral use.
Granijiet li jfexfxu ta ’ sodium hydrogen carbonate Użu orali
To be used with DUKORAL.
Biex jintuża ma ’ DUKORAL.
5.6 g
5. 6 g
SBL Vaccin AB, Sweden
SBL Vaccin AB, L- Iżvezja
PACKAGE LEAFLET
21 FULJETT TA 'TAGĦRIF:
DUKORAL suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
DUKORAL, suspensjoni u granijiet li jfexfxu għal suspensjoni għal użu orali Vaċċin kontra l- kolera (inattivat, orali)
Read all of this leaflet carefully before you start using this vaccine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu dan il- vaċċin.
- This vaccine has been prescribed for you.
- Dan il- vaċċin ġie mogħti lilek.
Do not pass it on to others.
M’ għandekx tgħaddih lil persuni oħra.
What DUKORAL is and what it is used for 2.
X’ inhu DUKORAL u għalxiex jintuża 2.
Before you use DUKORAL 3.
Qabel ma tuża DUKORAL 3.
How to use DUKORAL 4.
Kif għandek tuża DUKORAL 4.
Possible side effects 5 How to store DUKORAL 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen DUKORAL 6.
WHAT DUKORAL IS AND WHAT IT IS USED FOR
X' INHU DUKORAL U GĦALXIEX JINTUŻA
DUKORAL is an oral vaccine against cholera that stimulates the immunological defence in the gut.
DUKORAL huwa vaċċin orali għal kontra l- kolera li jistimula d- difiża immunoloġika ta ’ l- imsaren.
The vaccine protects adults and children from 2 years of age against cholera.
Il - vaċċin jipproteġi l- adulti u tfal mill- età ta ’ sentejn kontra l- kolera.
BEFORE YOU USE DUKORAL
QABEL MA TUŻA DUKORAL
Do not use DUKORAL
Tużax DUKORAL:
- if you are allergic to any ingredient of the vaccine or to formaldehyde.
- jekk inti allerġiku/ a għal xi sustanza li tinsab fil- vaċċin jew għal formaldehyde.
- if you have an acute stomach disorder or infection with fever (vaccination should be delayed).
- jekk għandek xi problema akuta fl- istonku jew infezzjoni bid- deni (vaċċinazzjoni għandha tiġi
Take special care with DUKORAL
differita).
-
Oqgħod attent ħafna b' DUKORAL:
Tell your doctor if you take a medical treatment that affects the immune system or if you have a disease of the immune system (including AIDS).
Għid lit- tabib tiegħek jekk qed tieħu xi kura medika li taffettwa lis- sistema immunitarja tiegħek jew jekk għandek marda fis- sistema immunitarja (inkluż AIDS).
The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
Il- vaċċin jista ’ jagħtik livell ta ’ protezzjoni aktar baxx minn dak li jipprovdi lil nies b’ sistemi immunitarji b’ saħħithom.
The vaccine does not provide complete protection and it is important to adhere to dietary and hygiene advice to avoid diarrhoeal diseases.
Il- vaċċin ma jagħtix protezzjoni sħiħa u huwa importanti li wieħed jaderixxi mal- parir tad- dieta u iġjene biex jevita mard b’ dijarea.
Using other medicines Do not take other medicine 1 hour before and 1 hour after taking the vaccine.
Meta tuża mediċini oħra Tiħux mediċini oħra siegħa qabel li tkun ħadt il- vaċċin.
Using DUKORAL with food and drink Avoid food and drink 1 hour before and 1 hour after the vaccination.
Evita li tiekol u tixrob minn siegħa qabel sa siegħa wara l- vaċċinazzjoni.
Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant or are breast-feeding.
Tqala u treddigħ Għid lit- tabib tiegħek jekk inti tqila, taħseb li inti tqila jew qed tippjana biex tiħroġ tqila jew inkella jekk tkun qed tredda ’.
Your doctor will decide if you should receive the vaccine DUKORAL ’
It- tabib tiegħek jiddeċiedi jekk għandekx tirċievi l- vaċċin DUKORAL.
Driving and using machines There are no reasons to suspect that DUKORAL will affect your ability to drive or handle machines
Ma hemm ebda raġuni l- għala wieħed għandu jissuspetta li DukoralDUKORAL jaffettwa l- ħila tiegħek li ssuq jew tħaddem magni.
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jiġi kkunsidrat minn pazjenti fuq dieta b’ teħid tas- sodju kkontrollat.
HOW TO USE DUKORAL Adults and children from 6 years of age:
Adulti u tfal mill- età ta '6 snin:
The primary vaccination is 2 doses.
Il- vaċċinazzjoni primarja hija ta ’ 2 dożi.
Doses are to be taken with an interval of 1 to 6 weeks.
Id- dożi għandhom jittieħdu f’ intervall ta ’ bejn ġimgħa sa 6 ġimgħat.
For continuous protection, re-vaccination is recommended after 2 years.
Għal ħarsien kontinwu, vaċċinazzjoni mill- ġdid hija rakkomandata wara sentejn.
If up to 2 years have passed since the last vaccination a single dose is sufficient.
Jekk ikunu għaddew sa sentejn mill- aħħar vaċċinazzjoni, doża waħda hija biżżejjed.
If more than 2 years have passed since the last vaccination, the primary vaccination (2 doses) should be repeated.
Jekk qabżu s- sentejn mill- aħħar vaċċinazzjoni, il- vaċċinazzjoni primarja (2 dożi) għandha tiġi ripetuta.
Children of 2 to 6 years of age:
Tfal mill- età ta 'bejn 2 sa 6 snin:
The primary vaccination is 3 doses.
Il- vaċċinazzjoni primarja hija ta ’ 3 dożi.
Only half of the amount of the sodium hydrogen carbonate solution should be mixed with the vaccine.
Nofs l- ammont biss tas - soluzzjoni ta ’ sodium hydrogen carbonate għandu jitħallat mal- vaċċin.
Doses are to be taken with an interval of 1 to 6 weeks.
Id- dożi għandhom jittieħdu f’ intervall ta ’ ġimgħa sa 6 ġimgħat.
For continuous protection, re-vaccination is recommended after 6 months.
Għal ħarsien kontinwu, vaċċinazzjoni mill- ġdid hija rakkomandata wara 6 xhur.
If more than 2 years have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.
Jekk ikunu qabżu s- sentejn mill- aħħar vaċċinazzjoni, il- vaċċinazzjoni primarja (3 dożi) għandha tiġi ripetuta.
Protection against cholera can be expected about 1 week after the primary vaccination is completed.
Ħarsien mill- kolera għandu jkun mistenni madwar ġimgħa wara li l- vaċċinazzjoni primarja tkun ittieħdet kollha
The vaccine is a whitish suspension supplied in a single-dose glass vial.
Il- vaċċin huwa suspensjoni bajdanija pprovduta b’ kunjett tal- ħġieġ ta ’ doża waħda.
Each dose of vaccine comes with one sachet package that contains white effervescent granules of sodium hydrogen carbonate.
Kull doża tal - vaċċin tiġi f’ pakkett ta ’ qartas wieħed li fih granuli effervexxenti bojod ta ’ sodium hydrogen carbonate.
The granules should be dissolved in a glass of water and mixed with the vaccine.
Il- granuli għandhom jiddewwbu f’ tazza ilma u għandhom jitħalltu mal- vaċċin.
The sodium hydrogen carbonate solution protects the vaccine from the gastric acid.
Is - soluzzjoni ta ’ sodium hydrogen carbonate tipproteġi lill- vaċċin kontra l- aċidu gastriku.
Drink the vaccine within 2 hours after mixing with the sodium hydrogen carbonate solution.
Ixrob il- vaċċin fi żmien sagħtejn wara li tħallat mas- soluzzjoni ta ’ sodium hydrogen carbonate.
Instructions:
Struzzjonijiet:
150 ml).
Dewweb il- granijiet li jfexfxu (sodium hydrogen carbonate) f’ tazza ilma frisk (madwar 150 ml).
Children 2-6 years: pour away half of the solution.
Tfal ta ’ bejn 2- 6 snin: armi nofs is- soluzzjoni
Mix well and drink the mixture.
Ħawwad sew u ixrob it- taħlita.
Like all medicines, DUKORAL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, DUKORAL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data) 24 Uncommon side effects (reported by less than 1 in a 100 but more than 1 in a 1,000 people) include: diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort, headache
23 Il- frekwenza tal- effetti sekondarji possibbli elenkati hawn taħt hija definita skont il- konvenzjoni li ġejja: komuni ħafna (taffettwa aktar minn utent 1 minn kull 10) komuni (taffettwa minn 1 sa 10 utenti minn kull 100) mhux komuni (taffettwa minn 1 sa 10 utenti minn kull 1, 000) rari (taffettwa minn 1 sa 10 utenti minn kull 10, 000) rari ħafna (taffettwa inqas minn utent 1 minn kull 10, 000) mhux magħrufa (il- frekwenza ma tistax tiġi stmata mid- dejta disponibbli)
Rare side effects (reported by less than 1 in a 1,000 but more than 1 in a 10,000 people) include: high temperature, generally feeling unwell, nausea, vomiting, loss of / or poor appetite, runny nose, cough and dizziness.
Effetti oħra mhux komuni (rapportati f’ inqas minn 1 fil- 100 imma aktar minn 1 f’ 1000 ruħ) jinkludu: dijarea, uġigħ fl- istonku, brim fl- istonku, stonku jgerger, stonku minfuħ, gass fl- istonku, skonfort ġenerali ta ’ l- istonku, uġigħ ta ’ ras
Very rare side effects (reported by less than 1 in a 10,000 people) include: fatigue/ feeling tired, shivering, severe diarrhoea, joint pain, sore throat, reduced sense of taste, sweating, being unable to sleep, general pain, hives or nettle rash, other types of rashes, flu-like symptoms, weakness, feeling cold, breathlessness, pins and needles, dehydration (loss of water from the body), swelling of face, high blood pressure, chestiness, itching, and swelling of the lymph glands.
Effetti oħra rari ħafna (rapportati f’ inqas minn 1 f’ 10, 000 ruħ) jinkludu: għeja/ tħossok għajjien, rogħda, dijarrea severa, uġigħ fil- ġogi, uġigħ fil- griżmejn, tnaqqis fis- sens ta ’ togħma, issir għarqan, ma tistax torqod, uġigħ ġenerali, ħorriqija jew urtikarja, tipi oħra ta ’ raxxijiet, sintomi bħal ta ’ l - influwenza, dgħjufija, tħoss il- bard, qtugħ ta ’ nifs, sensazzjoni ta ’ tniggiż, diżidratazzjoni (telf ta ’ ilma mill- ġisem), wiċċ minfuħ, pressjoni għolja tad- demm, disturbi tan- nifs, ħakk, u nefħa tal- glandoli limfatiċi
HOW TO STORE DUKORAL
KIF TAĦŻEN DUKORAL