FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood and lymphatic system disorders: Lymphadenitis Nervous system disorders: Paraesthesia
Slovenian: Bolezni krvi in limfatičnega sistema: limfadenitis Bolezni živčevja: parestezija
English: Over 94,000 doses of Dukoral were administered during the clinical trials.
Slovenian: V teh kliničnih preskušanjih so dali več kot 94.000 odmerkov cepiva Dukoral.
English: Loss of /or poor appetite Very rare Dehydration
Slovenian: Presnovne in prehranske motnje Redki izguba ali poslabšanje apetita Zelo redki dehidracija
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA
English: The antibacterial intestinal antibodies prevent the bacteria from attaching to the intestinal wall thereby impeding colonisation of V. cholerae O1.
Slovenian: Protitelesa proti bakterijam v črevesu preprečujejo bakterijam, da bi se vezale na steno črevesa, in tako onemogočijo kolonizacijo bakterije V. cholerae O1.
English: Each dose of vaccine is supplied as one vial of suspension together with one sachet of effervescent granules.
Slovenian: Vsak odmerek cepiva je na voljo kot ena viala suspenzije z eno vrečico šumečih zrnc.
English: Duration of vaccine protection differed by age, lasting for 6 months in children and for 2 years in adults (see table below).
Slovenian: Trajanje zaščite cepiva se je razlikovalo med starostnimi skupinami in je bilo 6 mesecev pri otrocih ter 2 leti pri odraslih (glejte preglednico spodaj).
English: The effervescent granules should be dissolved in a glass of cool water, and the resulting buffer solution should be mixed with the suspension.
Slovenian: Šumeča zrnca je treba raztopiti v kozarcu hladne vode in dobljeno pufrsko raztopino zmešati s suspenzijo.
English: The vaccine induced intestinal antitoxin IgA responses in 70-100% of vaccinated subjects.
Slovenian: Cepivo je pri 70-100 % cepljenih osebah sprožilo odziv črevesnih protitoksinskih protiteles IgA.
English: The standard primary course of vaccination with Dukoral against cholera consists of 2 doses for adults and children from 6 years of age.
Slovenian: Standardno primarno cepljenje proti koleri s cepivom Dukoral je za odrasle in otroke nad 6 let sestavljeno iz 2 odmerkov.
English: For continuous protection against cholera a single booster dose is recommended within 2 years for adults and children from 6 years of age, and within 6 months for children aged 2 to below 6 years.
Slovenian: Za dolgotrajno zaščito proti koleri je priporočen enojni poživitveni odmerek v 2 letih za odrasle in otroke, starejše od 6 let, ter v 6 mesecih za otroke, stare od 2 do 6 let.
English: DUKORAL suspension Oral use.
Slovenian: DUKORAL suspenzija peroralna uporaba
English: The sodium hydrogen carbonate is supplied as effervescent granules, which should be dissolved in a glass of cool water (approx. 150 ml).
Slovenian: Natrijev hidrogenkarbonat je na voljo v obliki šumečih zrnc, ki jih je treba raztopiti v kozarcu hladne vode (približno 150 ml).
English: • The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water for injections.
Slovenian: • Pomožne snovi v suspenziji za cepljenje so natrijev dihidrogenfosfat, dinatrijev hidrogenfosfat, natrijev klorid in voda za injekcije.
English: It is important to use the buffer solution, as it protects the vaccine from the gastric acid.
Slovenian: Uporaba pufrske raztopine je pomembna, ker ščiti cepivo pred želodčno kislino.
English: The suspension should then be mixed with the buffer solution and drunk within 2 hours.
Slovenian: Suspenzijo je treba nato premešati s pufrsko raztopino in spiti v najkasneje 2 urah.
English: 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.
Slovenian: Najpogostejši neželeni učinki, kot so prebavne težave, vključno z bolečinami v trebuhu, drisko, redkim blatom, slabostjo in bruhanjem, so bili podobno pogosti v skupini, ki je prejemala cepivo, in v skupini, ki je prejemala placebo.
English: Dukoral may not induce protective antibody levels in subjects with advanced HIV disease.
Slovenian: Cepivo Dukoral morda ne bo sprožilo zaščitnih ravni protiteles pri bolnikih, pri katerih je bolezen HIV že napredovala.
English: Valneva Sweden AB S-105 21 Stockholm Sweden infodukoral@valneva.com
Slovenian: Valneva Sweden AB S-105 21 Stockholm Švedska infodukoral@valneva.com
English: It takes about 1 week after the last dose for protection to begin.
Slovenian: Zaščita začne delovati približno 1 teden po zadnjem odmerku.
English: Bacterial strains of both Inaba and Ogawa serotypes and of El Tor and Classical biotypes are included in the vaccine.
Slovenian: Cepivo vsebuje bakterijske seve obeh serotipov, Inaba in Ogawa, ter biotipov El Tor in klasičnega biotipa.
English: Year
Slovenian: Leto
English: Pack sizes: 1x1 dose, 2x1 dose, 20x1 dose Not all pack sizes may be marketed.
Slovenian: Velikosti pakiranj: 1 x 1 odmerek, 2 x 1 odmerek, 20 x 1 odmerek Na trgu morda ni vseh navedenih pakiranj.
English: Suspension and effervescent granules for oral suspension: - Suspension for oral suspension
Slovenian: suspenzija in šumeča zrnca za peroralno suspenzijo: - suspenzija za peroralno suspenzijo
English: Dukoral is taken orally with bicarbonate buffer, which protects the antigens from the gastric acid.
Slovenian: Dukoral se uporablja peroralno, z bikarbonatnim pufrom, ki ščiti antigene pred želodčno kislino.
English: Adults and children from 6 years of age: The primary vaccination is 2 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart.
Slovenian: Odrasli in otroci, starejši od 6 let: Primarno cepljenje obsega 2 odmerka, ki se vzameta peroralno (skozi usta) s presledkom najmanj 1 tedna (do 6 tednov).
English: If more than 2 years have elapsed since the last vaccination (more than 6 months for children aged 2 to below 6 years) the primary course should be repeated.
Slovenian: Če sta od zadnjega cepljenja pretekli več kot 2 leti (oz. več kot 6 mesecev pri otrocih, starih od 2 do 6 let), je treba ponoviti primarno cepljenje.
English: See the package leaflet for further information.
Slovenian: Za dodatne informacije glejte navodila za uporabo.
English: If more than 6 weeks have elapsed between doses, the primary immunisation course should be re-started.
Slovenian: Če je med odmerkoma preteklo več kot 6 tednov, morate ponovno začeti primarno imunizacijo.
English: Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dihydrate Sodium chloride
Slovenian: natrijev dihidrogenfosfat dihidrat dinatrijev hidrogenfosfat dihidrat natrijev klorid voda za injekcije
English: Only half of the amount of the buffer solution should be mixed with the vaccine.
Slovenian: S cepivom je treba zmešati samo pol pufrske raztopine.
English: 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.
Slovenian: V podobni raziskavi so sočasno dajali cepivo proti rumeni mrzlici in cepivo Dukoral ter niso opazili interakcij pri imunskem odzivu na cepivo proti rumeni mrzlici.
English: 5 How to store Dukoral Contents of the pack and other information
Slovenian: Shranjevanje zdravila Dukoral Vsebina pakiranja in dodatne informacije
English: Dukoral is an oral vaccine against cholera that stimulates the immunological defence in the gut.
Slovenian: Dukoral je peroralno cepivo proti koleri, ki spodbuja imunski odziv v črevesu.
English: You can take the 2nd dose of Dukoral up to 6 weeks after the 1st dose (children of 2 to below 6 years have to take 3 doses).
Slovenian: Drugi odmerek zdravila Dukoral lahko vzamete do 6 tednov po prvem odmerku (otroci, stari od 2 do
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).
Slovenian: Po poživitvenem odmerku, danem 10-12 mesecev po primarni imunizaciji, je bila učinkovitost zaščite v drugem letu 60,5-odstotna (interval zaupanja 95 %:
English: How to use Dukoral
Slovenian: Kako uporabljati zdravilo Dukoral
English: After the effervescent granules have been dissolved in water and the vaccine suspension has been added, the mixture should be drunk within 2 hours.
Slovenian: Po raztapljanju šumečih zrnc in dodajanju suspenzije za cepljenje morate mešanico spiti najkasneje v 2 urah.
English: Dukoral contains approximately 1.1 g sodium per dose.
Slovenian: Zdravilo Dukoral vsebuje približno 1,1 g natrija na odmerek.
English: Administration of Dukoral should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness.
Slovenian: Uporabo cepiva Dukoral je treba prestaviti pri bolnikih z akutno boleznijo prebavnega trakta ali akutno povišano telesno temperaturo.
English: The suspension is a whitish suspension supplied in a vial.
Slovenian: Suspenzija je belkasta suspenzija, ki je na voljo v viali.
English: Children of 2 to below 6 years of age: The primary vaccination is 3 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart.
Slovenian: Otroci, stari od 2 do 6 let: Primarno cepljenje obsega 3 odmerke, ki se vzamejo peroralno (skozi usta) s presledkom najmanj 1 tedna (do 6 tednov).
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.
Slovenian: V vzdolžni kohortni analizi, opravljeni med kampanjo množičnega cepljenja v Zanzibarju, je bila učinkovitost zaščite po 2 odmerkih cepiva Dukoral 79 % (95 % interval zaupanja, 47, 92) v 15 mesecih spremljanja.
English: Study location
Slovenian: Kraj raziskave
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.
Slovenian: Otroci, stari od 2 do 6 let: polovico pufrske raztopine zlijte stran in preostanek (približno 75 ml) premešajte s celotno vsebino viale s cepivom.
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 vial.
Slovenian: Otroci, stari od 2 do 6 let: polovico pufrske raztopine zlijte stran in preostanek (približno 75 ml) premešajte s celotno vsebino viale.
English: Skin and subcutaneous tissue disorders: Urticaria, angioedema, pruritus General disorders and administration site conditions: Pain, flu-like syndrome, asthenia, chills
Slovenian: Bolezni kože in podkožja: urtikarija, angioedem, pruritus Splošne težave in spremembe na mestu aplikacije: bolečine, gripi podoben sindrom, astenija, mrzlica
English: Follow up
Slovenian: Sledenje
English: Shake the Dukoral® suspension vial (1 vial = 1 dose).
Slovenian: Pretresite vialo z zdravilom Dukoral® suspenzija (1 viala = 1 odmerek).
English: The effervescent granules are white with a raspberry flavour and are supplied in a sachet.
Slovenian: Šumeča zrnca so bela, z okusom po malinah in pakirana v vrečici.
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).
Slovenian: Varnost cepiva Dukoral so ocenili v kliničnih preskušanjih, v katerih so sodelovali odrasli in otroci, starejši od 2 let, opravljenih v državah, endemičnih in neendemičnih za kolero in enterotoksigeno
English: No established immunological correlates of protection against cholera after oral vaccination have been identified.
Slovenian: Imunološke korelacije zaščite proti koleri po peroralnem cepljenju niso opredelili.
English: If more than 6 months have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.
Slovenian: Če je od zadnjega cepljenja preteklo več kot 6 mesecev, je treba ponoviti primarno cepljenje (3 odmerki).
English: What Dukoral looks like and contents of the pack
Slovenian: Izgled zdravila Dukoral in vsebina pakiranja
English: If less than 6 months have passed since the last vaccination a single dose will renew the protection.
Slovenian: Če je od zadnjega cepljenja preteklo manj kot 6 mesecev, bo en odmerek zadostoval za obnovo zaščite.
English: • The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavour.
Slovenian: • Šumeča zrnca vsebujejo natrijev hidrogenkarbonat, citronsko kislino, natrijev karbonat, natrij saharinat, natrijev citrat in aromo maline.
English: If you had your last dose of vaccine less than 2 years ago a single dose will renew your protection.
Slovenian: Če je od zadnjega odmerka cepiva preteklo manj kot 2 leti, vam bo en odmerek zadostoval za obnovo zaščite.
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.
Slovenian: Suspenzija za cepljenje je polnjena v 3-mililitrskih vialah (steklo tipa I) z gumijastim zamaškom
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.
Slovenian: Vendar imunološki podatki in podatki o trajanju zaščite kažejo, da je treba odraslim, če sta od zadnjega cepljenja pretekli do 2 leti, in otrokom, starim od 2 do
English: Very rare side effects (may affect up to 1 in a 10,000 people)
Slovenian: Zelo redki neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 10.000):
English: Dukoral is presented as a suspension and effervescent granules for oral suspension.
Slovenian: Zdravilo Dukoral je na voljo kot suspenzija in šumeča zrnca za peroralno suspenzijo.
English: For children of 2 to below6 years: pour away half of the buffer solution.
Slovenian: Za otroke od 2 do 6 let: odlijte stran pol pufrske raztopine 2.
English: The anti-toxin intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface thereby preventing the toxin-mediated diarrhoeal symptoms.
Slovenian: Protitelesa proti toksinu preprečujejo toksinu kolere, da bi se vezal na sluznico črevesa, in tako preprečijo simptome driske, ki jih ta toksin povzroča.
English: • Flu -like symptoms, chestiness, chills, general pain, weakness
Slovenian: • gripi podobni simptomi, respiratorni simptomi, mrazenje, splošne bolečine, oslabelost,
English: • Diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort
Slovenian: • driska, bolečine v trebuhu, krči v trebuhu, klokotanje v trebuhu, napenjanje v trebuhu, vetrovi in splošen neprijeten občutek v trebuhu,
English: No animal data on reproduction toxicity are available.
Slovenian: Na voljo ni podatkov o vplivu zdravila na sposobnost razmoževanja pri živalih.
English: • Give the 2nd dose to the child at least 1 week after the 1st dose.
Slovenian: • Otroku dajte drugi odmerek najmanj 1 teden po prvem odmerku.
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.
Slovenian: V študiji primerov, opravljeni med kampanjo množičnega cepljenja v Mozambiku, je bila učinkovitost zaščite 2 odmerkov cepiva Dukoral v prvih 5 mesecih spremljanja 84 % (95 % interval zaupanja: 43, 95, analiza po protokolih, p = 0,005).
English: To be used with DUKORAL.
Slovenian: Za uporabo s cepivom DUKORAL.
English: − Recombinant cholera toxin B subunit (rCTB) 1 mg
Slovenian: − rekombinantno podenoto toksina kolera B (rCTB) 1 mg
English: Protective efficacy of Dukoral against cholera has not been studied following repeated booster vaccination.
Slovenian: Učinkovitosti zaščite cepiva Dukoral po večkratnih poživitvenih cepljenjih niso raziskovali.
English: - granules for oral suspension in a sachet ::
Slovenian: - zrnca za peroralno suspenzijo v vrečici:
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).
Slovenian: V drugem preskušanju, ki so ga opravili pri vojaških nabornikih v Peruju, je bila kratkoročna učinkovitost zaščite proti koleri po dveh odmerkih cepiva 85-odstotna (interval zaupanja 95 %: 36, 97,
English: In subjects infected with HIV, limited data are available on immunogenicity and safety of the vaccine.
Slovenian: Na voljo je le malo podatkov o imunogenosti in varnosti cepiva pri bolnikih, okuženih z virusom HIV.
English: • Give the 1st dose to the child no later than 3 weeks before you leave for your trip.
Slovenian: • Otroku dajte prvi odmerek najpozneje 3 tedne pred odhodom na potovanje.
English: The vaccine acts by inducing antibodies against both the bacterial components and CTB.
Slovenian: Cepivo deluje tako, da sproži nastanek protiteles proti bakterijski komponenti in podenoti B toksina kolere (CTB).
English: Additional adverse reactions reported during post-marketing surveillance are listed below.
Slovenian: Neželeni učinki iz nadzora po prihodu cepiva na trg Drugi neželeni učinki, o katerih so poročali med nadzorom po prihodu cepiva na trg, so našteti spodaj:
English: The vaccine is acid labile.
Slovenian: Cepivo je nestabilno v kislinah.
English: Active substances: 1 dose contains
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Učinkovine: 1 odmerek vsebuje
English: Dukoral contains sodium
Slovenian: Zdravilo Dukoral vsebuje natrij
English: (produced in V. cholerae O1 Inaba, classical biotype strain 213.)
Slovenian: (pridobljen s pomočjo bakterije V. cholerae O1 Inaba, klasičnem biotipu, sev 213)
English: • Take the 2nd dose at least 1 week after the 1st dose and at least 1 week before your trip.
Slovenian: • Vzemite drugi odmerek najmanj 1 teden po prvem in najmanj 1 teden pred potovanjem.
English: 2x1 dose
Slovenian: 2 x 1 odmerek
English: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated)
Slovenian: Vibrio cholerae O1 Inaba, klasični biotip (inaktiviran s toploto)
English: Do not use Dukoral after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: No clinical data on protective efficacy of Dukoral against cholera after administration of booster doses are available.
Slovenian: Na voljo ni nobenih kliničnih podatkov o učinkovitosti zaščite cepiva Dukoral proti koleri po dajanju poživitvenega odmerka.
English: 20x1 dose
Slovenian: 20 x 1 odmerek
English: • Take the 1st dose no later than 2 weeks before you leave for your trip.
Slovenian: • Vzemite prvi odmerek najpozneje 2 tedna pred odhodom na potovanje.
English: If more than 2 years have passed since you had the last vaccine dose, the primary vaccination (2 doses) should be repeated.
Slovenian: Če je od zadnjega odmerka cepiva preteklo več kot 2 leti, morate ponoviti primarno cepljenje (2 odmerka).
English: Valneva Sweden AB, 105 21 Stockholm, Sweden.
Slovenian: Valneva Sweden AB, 105 21 Stockholm, Švedska.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING DUKORAL - 1 dose package, 2x1 dose package, 20x1 dose package (outer sleeve)
Slovenian: DUKORAL - pakiranje po 1 odmerek, pakiranje 2 x 1 odmerek, pakiranje 20 x 1 odmerek (zunanji ovoj)
English: Do not take other medicine starting 1 hour before until 1 hour after taking the vaccine.
Slovenian: Eno uro pred jemanjem cepiva in eno uro po tem ne jemljite drugih zdravil.
English: Vomiting, nausea Very rare Sore throat, dyspepsia
Slovenian: Zelo redki bolečine v grlu, dispepsija
English: Other side effects: Uncommon side effects (may affect up to 1 in a 100 people)
Slovenian: Občasni neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 100):
English: An exploratory analysis suggested that 2 vaccine doses seemed as effective as 3 doses in adults.
Slovenian: odmerka cepiva enako učinkovita kot 3 odmerki.
English: Nervous system disorders Uncommon Headache Rare
Slovenian: Bolezni živčevja Občasni glavobol
English: Mix suspension with buffer solution before drinking.
Slovenian: Pred pitjem suspenzijo zmešajte s pufrsko raztopino.
English: - Granules for oral suspension in a sachet.
Slovenian: - zrnca za peroralno suspenzijo v vrečici
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.
Slovenian: Dukoral v celotni populaciji 85-odstotna (interval zaupanja 95 %: 56, 95, analiza po protokolih).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 sodium hydrogen carbonate sachets)
Slovenian: DUKORAL - pakiranje 20 x 1 odmerek (stična ovojnina za 20 vrečic z natrijevim hidrogenkarbonatom)
English: If you have taken more than one dose at one time, please contact your doctor, pharmacist or nurse.
Slovenian: Če ste vzeli več kot en odmerek naenkrat, se obrnite na svojega zdravnika, farmacevta ali medicinsko sestro.
English: Pour the content of the Dukoral® suspension vial into the glass of buffer solution (see 1).
Slovenian: Prelijte vsebino viale z zdravilom Dukoral® suspenzija v kozarec pufrske raztopine (glejte
English: If you take the doses less than one week apart, contact your doctor, pharmacist or nurse.
Slovenian: Če ste vzeli odmerke z manj kot enim tednom presledka, se obrnite na svojega zdravnika, farmacevta ali medicinsko sestro.
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.
Slovenian: Vsaki viali je priložena ena vrečica z belimi šumečimi zrnci natrijevega hidrogenkarbonata.
English: The immune responses to Dukoral were not studied.
Slovenian: Imunskega odziva na cepivo Dukoral niso raziskovali.
English: No other vaccines/ medicinal products, including oral polio vaccine and antimalarials, have been given simultaneously with Dukoral in clinical studies.
Slovenian: V kliničnih študijah niso skupaj s cepivom Dukoral dajali nobenega drugega cepiva ali zdravila, vključno s cepivom proti otroški paralizi in z antimalariki.
English: Sodium hydrogen carbonate
Slovenian: Natrijev hidrogenkarbonat šumeča zrnca
English: Consequently, food and drink should be avoided 1 hour before and 1 hour after vaccination.
Slovenian: Zato se je uro pred cepljenjem in uro po njem treba izogibati hrani in pijači.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 vaccine vials)
Slovenian: PODATKI NA PRIMARNI OVOJNINI DUKORAL - pakiranje 20 x 1 odmerek (stična ovojnina za 20 vial s cepivom)
English: Dukoral suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
Slovenian: Dukoral suspenzija in šumeča zrnca za peroralno suspenzijo cepivo proti koleri (inaktivirano, peroralno)
English: Valneva Sweden AB SE-105 21 Stockholm Sweden
Slovenian: Valneva Sweden AB SE-105 21 Stockholm Švedska
English: • Generally feeling unwell, feeling dizzy
Slovenian: • splošno slabo počutje, omotica,
English: • Nausea (feeling sick), vomiting, loss of /or poor appetite
Slovenian: • navzea (siljenje na bruhanje), bruhanje, izguba ali poslabšanje apetita, • otekla in razdražena notranjost nosu, kašelj.
English: • Numbness or pins and needles
Slovenian: • otrplost ali mravljinčenje,
English: Valneva Sweden AB 105 21 Stockholm, Sweden
Slovenian: Valneva Sweden AB 105 21 Stockholm, Švedska
English: Adverse reactions reported are consistent with those seen after the recommended dosing.
Slovenian: Neželeni učinki, o katerih so poročali, so skladni s tistimi,